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Gary Baker, Esq., M.T.

BioPatentSm IP of Quinelaw

Gary Baker, Esq., MT 

Gary Baker, Esq., MT

 

Managing Director of the Quine IP Law Group

Intellectual Property and Biotech Blog

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Many articles talk about what happened, without touching on the how or why. 

 This blog is intended to fill in legal, technical, or political background information left out of the stories. 

Please read hyperlinked stories, then my insightful comments!

Comments herein are opinion and not to be relied on as legal advice.  

 

April 28, 2017

Long Live the King Without Any Clothes

I can see “sovereign immunity” of government agencies for imperfections in carrying out their responsibilities.  But, this seems different. 

An inter partes review (IPR) is more of an attack on the intellectual property (the “res") than the University of Florida.  That is, I can see a policy of protecting the people (yes – the government is the people), but it seems unreasonable to give intellectual property rights to, e.g., “inventions” that maybe are not new. 

April 27, 2017

Big New (OLD) Life Saver in a Small Package

This drug is unusual in many ways.  Cheap, non-toxic, unprotected.   

Tranexamic acid (a cyclohexane carboxylic acid with an amine hanging out para) is an analog of the amino acid lysine.  It provides an antifibrinolytic function by reversibly binding lysine receptor sites on plasminogen or plasmin (enzyme that dissolves clots).   

An inexpensive, non-toxic dose can significantly reduce loss of blood in many situations, including child birth.

So, buy up a lot of stock in Pfeizer and all the other manufacturers of this simple unpatented drug.  Gee, sometimes good things do come in small molecules. 

April 25, 2017

Balanced GMO Review, Based on Facts

See the interesting video in the article. 

April 24, 2017

Another Pharma Activity of Frog Slime

No, this frog slime is not for poison arrows or hallucinogenicisis.  Here the slime component “blows viruses apart”!

No mention of possible mode of action.  Not likely only a hemagglutinin blocker if they expect it to be broad spectrum to HIV, zika and ebola.

And, no mention of the fact it would be one use only, with the patient producing antibodies against it before their next viral illness.

April 18, 2017

CRISPR in Agriculture is Not Genetically Engineered, Frankly  

This article is a good Ag CRISPR review with a great selection of interesting hyperlinks.  Some of the content is a little annoying, with allegedly greedy people taking advantage of everyone.  For example, did you know that starting at least a century ago, our forefathers developed hybrid plants solely so that they could get rich selling single-use seeds, the farmer would have to repurchase every season?  Then there is the excerpt from the upcoming PBS “Seed” series, playing ominous music while suggesting a corporation can take a plant, changing “one gene in ten thousand” and “control the whole plant forever.”  Of course, this is ridiculous because only the specific new plant is owned by the inventor, and patents – expire.  For example, most Roundup Ready patents expire about NOW (Roundup Ready soy beans expired in 2015; now free for anyone to produce, use and sell).

I agree purchasers of food should have all the information they can use to make rational buying decisions.  However, many liberal arts graduate journalists with no science background have misinformed the general public to the extent they see the entire biotech industry as dangerous and greedy.  No matter how a gene has been manipulated (increasing productivity or health), the seed of paranoia has been planted and consumers will be frightened.  The USDA has confirmed they will not be regulating the field testing of non-browning knock out mushrooms.  That is a good start (what will FDA, EPA, and FBI have to say?).  I guess a good compromise would be to label Frankenfood (however generally recognized as safe) and not label knock outs.  

There is quite a section in the article discussing what it means to be “genetically engineered” (GE) or to be a “genetically modified organism” (GMO).  It’s a problem that GMO is associated with “Frankenfood” that, e.g., recombines a gene from one animal with another (gross … with theoretical problems that are avoidable and extremely unlikely).  A plant with a genetically engineered “knock out” deletion is literally GE or a GMO, while the same plant knocked out by natural selection is not.  Would labeling such plants GMO, or GE, or knock out actually provide useful information to the average shopper?  Eskimos (ok, Inuit) have 100 words for “snow”.  Maybe we can train the public to distinguish a variety of genetically engineered products; how about - non-franken, GMO lite, extra CRISPR …  

Industry is pushing for not labeling CRISPR modified organisms because, e.g., gene insertions are more controlled and safe than with the old style endonucleases.  Good luck to them.  Many such modifications may still be considered GMO, and unintended gene modifications are still possible.

I agree it is too bad that major seed suppliers and chemical manufacturers are teaming up.  This produces undesirable motivations to provide seed plants dependent on chemicals.  If nothing else, this continues make the biotech industry look bad.  When I was a kid, I remember walking the rows of Uncle Jimmy’s potato fields pulling weeds by hand.  Worked pretty well.  Got lots of pretty “potato bugs” in my rubber boots.  The weeds did not seem to become resistant.  Instead of poisons, I bet someone could design a robot that zaps of pulls weeds – anyone? 

Another interesting topic in the article is the Broad Institute licensing of CRISPR/Cas9 technology.  Wow, a “non-exclusive license to use CRISPR/Cas9 is valued at $265 million.”  I wonder where they got that number.  That pretty much freezes out small players.  How complicated can this money grab get?  UC Berkeley lost their Interference against the Broad Institute CRISPR in animal patents, but is appealing.  UCB recently was granted CRISPR in cell patents in Europe.  How much of the $265 million will UCB claw back once their U.S. patents issue? 

Importantly, how much less will the CRISPR/Cas9 patents be worth, once they have to compete with the follow-on technologies, e.g. of CRISPR/cpf1?  See: 

https://www.nature.com/articles/ncomms14406

April 17, 2017

Hybrid “Jet” Supported by Boeing. 

OK, this is neat and must have something going for it, if Boeing is involved.

Still the journalist is annoying with his ignorance and/or puffery.

First, this is not a “jet”.  Looks like a jet.  What wing loading. 

The main feature not discussed is battery technology.  If this plane is to run on lithium batteries, it is not going to be fast or have a 700 mile range (without a large generator). 

The article fails to mention what would be the airspeed of this aircraft.  I expect that with a 700 mile range, the speed would have to be slow.  Could be that I am wrong, though, because the author says – “The flights will be shorter, too, because planes will be able to travel faster without burning excess fuel.”  So I must be wrong.

April 14, 2017

UC Berkeley Appeals Patent Board Decision on CRISPR, and Has Issued Patent in Europe

What’s up with the Broad/UCB conflict over CRISPR/Cas9 patent rights?

Apparently UC Berkeley has Appealed their loss in the Interference against the issued Broad Institute patents directed to CRISPR use in animals. 

From my point of view, evidence is strong that the step from animal cells to animals was probably obvious and not patentable.  However, it is an additional burden in the justice system to overturn a finalized Decision.   

I see UCB actually has an issued CRISPR patent under their belt.  The sister case in Europe has issued with claims including CRISPR in cells and methods of use for treatment of a patient.  These claims do not go so far as claiming Use of CRISPR directly in whole animals.  See EPO case history including “claims” at:

https://register.epo.org/application?number=EP13793997&lng=en&tab=doclist

It is becoming more generally agreed that Broad Institute will need to license UCB patents in order to practice CRISPR/Cas9 in animals (e.g., human patients).  Do you think the bigger market might be in UCB CRISPR uses outside of direct medical interventions anyway?  As long as UCB gets claims issued in the U.S. with the same scope as in Europe, I think they will still be the dominant player in CRISPR/Cas9. 

April 12, 2017

Ridiculous Patent Stories are Toast

Human interest stories can be fun.  Sometimes you need a hero and villain to make it fun.  Sometimes, you need ignorance and carelessness to make it work, and this can be found in abundance.  

The “ridiculous patents” stories start with a premise, e.g., that “anything that’s unique is patentable.”  So … if the Patent Examiner search does not find the invention (including some extraneous feature unrelated to the problem solved by the invention) a patent will allegedly be issued.  From there, a patent troll can make demands knowing accused will pay rather than pay the costs of Federal Court.   

Take the ridiculous patents stories.  Isn’t is crazy that someone was able to patent toast?  Actually … not.  The patent at issue (U.S. 6,080,436 - http://www.integrityip.com/Patent_Library/Patents/Topics/6080436.pdf

) is not to toast, but to a new (and non-obvious) method of making toast with a special toaster 2500 F degree or more.  Note that, the red-orange color of heat elements in regular toasters suggest a temperature of not more than 2000 F. 

What is ridiculous is that the journalists suggest that makers of toast and toasters could be sued for infringement, even though we all know these existed (prior art) long before the patent was filed.  You cannot get a patent to something old.  And, a method claim does not cover the method product or machines (whether they are capable of practicing the method or not).     

The ridiculous thing is that citizens are so ignorant that “journalists” can make money on web page traffic baiting with such ridiculous content. 

April 11, 2017

Antibiotic Use In Infants May Change Their Personality As Adults

Another example of how an individual’s gut flora (microbiome) can have an influence on most aspects of health and well-being. 

Changes in the bacteria lining the gut has a big effect on immune responses and levels of inflammation.  Have you ever seen a photomicrograph of intestine histology at an inner surface (mucosa)?  The bulk of it is lymphocytes. 

It is not hard to imagine how changes in microbe and antigen exposure here could change cytokine and other signals influencing the levels of inflammation throughout the body.  And changes in general inflammation could ultimately change the emotional stress experienced by mice and humans. 

This is another reason to avoid unnecessary antibiotic use.  I have rarely intentionally used antibiotics most of my life.  Gosh, I feel happy and unstressed. 

April 10, 2017

India Forces Sale of Patented Bt Seeds at “Reasonable” Price

India is good at determining “reasonable and affordable” costs for Bt GMO cotton seeds, for its citizens in the major cotton producing country, against the bad old foreign corporation (Monsanto).

But wait … if the terms of the original seed contract was unreasonable and unaffordable, why did the Indian seed wholesaler agree to the terms in the first place? 

April 7, 2017

Long and Short-term Memories BOTH Initiated In Real Time

The old theory of memory construction wasn’t exactly dogma, but almost.  And it seemed to jive pretty well with the facts.  Present occurrences were said to be retained in short term memory deep in the brain (hippocampus), then transferred later for safe long-term keeping in the cortex. 

This was probably Wrong.  This new work, concerning memories of stressful situations, suggests that the initial structure of long-term memories is put in place about the same time as the short–term memory (as it happens).  The short term memory is lost, while the structure of the initial long-term memory is “consolidated”.

Still, the hippocampus does retain a central role in helping establish the long-term memory, but more immediately than we thought.

I will have to review this article when I get a chance to read it at work.    See Science Abstract at:

http://science.sciencemag.org/content/356/6333/73

March 30, 2017

Powerful Antibody Against B-cells Dramatically Treats All Forms of MS

This is great news for one of our best friends, and for my wife (who got a T-shirt at Genentech yesterday for the big success in FDA licensing Ocrelizumab treatment for Multiple sclerosis). 

The Ocrelizumab is an antibody against beta lymphocytes (B cells).  The target antigen is CD20, which is apparently present in the membrane of nearly all B cells.  See a little more information at:

http://www.nejm.org/doi/full/10.1056/NEJMoa1601277

CD20 may be a calcium channel somehow associated with attack of “T-cell independent” antigens.  Now that this is out, I should get the details from my wife. 

It does not make sense that “majority of these cells live deep inside the brain, but about 2 percent circulate through the blood”.  The journalist must be talking about some mysterious subset of B cells that are the actors attacking the nerve cell sheaths.

If all B cells have this antigen, why is there no mention of side effects from resduction of the very important beta lymphocytes that are the primary active immunity cells producing antibodies that protect us from disease?

The amazing news is that the Ocrelizumab reduces relapse rates by 47 percent, disability by 43 percent, and shrinks brain lesions by 95 percent!  And, seems to benefit all forms of MS.  Yay.

March 29, 2017

NSAIDs Should Be Prescription Drugs. 

I always hear that if Aspirin were up for an NDA today it would never be licensed for sale.  This article is strongly suggesting it and other NSAIDs not be sold at checkout stands of grocery stores.  However, from the totality of what I have read over the years, I suspect Aspirin saves more lives with open retail sales than without. 

The article notes a 20% “association” of NSAIDs to heart failure.  I suspect this may be because people with heart conditions often take NASIDS.  A proposed mode of causation is that NSAIDS increase blood pressure and likelihood of clot formation.  NSAIDS are all painted with the same broad brush, with Aspirin not distinguished, e.g., from Ibuprophin

At least the article seems to talk scientifically.  Still, I do not want to get a prescription for the “children’s” Aspirin I take every now and then. 

March 23, 2017

State School Tech Transfers are Royal.  No PTAB IPR Reviews.

The PTAB refused to prosecute an Inter Partes Review (IPR) against a patent held by the University of Florida technology transfer office because it is said to have sovereign immunity against prosecution by an essentially Federal  judicial branch entity. 

According to the 11th Amendment to the Constitution (  This does not seem to make sense for a couple of reasons.  The 11th Amendment protects the U.S. government from the courts, but arguably does not protect the States.  And, the University is arguably not even the state.  (OK, I have not studies Constitutional law for 20 years.)

I have heard of “good ole boy” networks, but now we have a “good ole big brother” network.  Government protecting government. 

This makes OTT patents more valuable in technology fields recently devastated by patent eligibility invalidations in IPR proceedings. 

March 22, 2017

siRNA Injection Providing Year of LDL Reduction in Patients

Apparently, there has previously been some success reducing Serum LDL using antibodies against the LDL receptor on hepatocytes.  However, this is expensive and requires shots once a month or more.

Here an RNAse resistant siRNA is injected once or twice a year, entering cells and inhibiting translation of the enzyme PCSK9 that degrades LDL receptors.   The siRNA is engineered with a 3x GalNAc at the sense 3’ end, enabling hepatic-specific uptake via ASGP receptor. 

See a good PowerPoint about the study at:

Side effects are mild (if any) and what you would expect from injection of a foreign RNA – mild flu symptoms.   

http://www.themedicinescompany.com/sites/default/files/pdf/Ray%20et%20al.%202016.pdf

A more complete description of the study is at:

http://www.nejm.org/doi/full/10.1056/NEJMoa1615758#t=article

I see no data on long term benefits.  Just as with cholesterol lowering statins, there may be little clinical benefit if high cholesterol does not CAUSE heart disease. 

March 21, 2017

Circular Track Runways

Ok, we all have to get real good at our side slip controlling.  It looks fun to land on the banked circular runway. 

There could be concentric runways that match the speed of the aircraft type.  Military on the outside, heavies in closer, and single engine piston in the center.  Just be sure you call your .. um, downwind. 

Great too, this complements well the proposed circular traffic pattern. 

The video named all the good things such runways would provide.  Can you think of any problems?

March 17, 2017

NIH Budgeted for a 20% Funding … CUT

OK, I am in shock.  I am not sure how we make America great(er) by reducing scientific research.

I was under the impression that the percent of NIH grant applications funded had already been going down for years.  Now, a 20% across the board reduction in NIH funding.  This is only President Trump’s budget, not yet the law.  Time to make some noise, if we care. 

I had been a little annoyed that the U.S. develop the bulk of innovations in medicine and the rest of the world expects to receive it all for free.  Now we can all enjoy for free all the medical discoveries never made. 

March 16, 2017

Government Research into Treatments and Devices to Mitigate Nuclear Disasters

It is the job of government to consider contingency plans.  Plans to stabilize bone marrow would be more helpful that passing out iodine pills during a radiation crisis. 

And, such advancements should provide benefits in other than times of emergency.

March 14, 2017

Long Term HIV Protection from Infusion of Antibodies

A passive neutralizing anti-HIV antibody combination infusion during acute SHIV infection provides long term benefit.  Apparently, the acute phase treatment reduces damage to the immune system and limits the reservoir of host genome-inserted virus.  The result can be long term reduction in viremia without additional treatments. 

See Nature Letter, at this ridiculously long URL: 

http://www.nature.com/articles/nature21435.epdf?referrer_access_token=RK_L5yg3_RMDtRcm_Tcrn9RgN0jAjWel9jnR3ZoTv0NfFMMCPD05u-ytsF1rzkhcPTHOsmtf11U7k60pORk6KlWjD4sEYzoHBx3CrzBQQnPoJcCr32cVf5y6ecjsnIuIIsGnwlkduaVUXNRGdxgOqkxwbIBnbLEYyXveq8pyfpwKJC1oPbOd_f8TdcXY3Wc8LlIWJEJ0nJrV61j-fV3UZBl8-QJoc3wRsKRYJQdYhvi4oumiJd4mlPsz7pu71mEYY_BNXkddZmaSKLMpyylNaw%3D%3D&tracking_referrer=www.ibtimes.co.uk 

Each of the two neutralizing antibodies were specific for the envelope (env) spike.  Three treatments were given starting 3 days after infection in monkeys. 

Long term protection may involve acute phase generation of immunostimulatory complexes with virus, followed with a delicate balance of continued low level stimulation as antigen leaks out of the weakened virus reservoir.  The acute phase stimulation raises a population of killer cells and maybe beta lymphocytes. 

I suspect it may be hard to infuse just the right initial antibody dosages to consistently protect a diverse population of human patients. 

March 7, 2017

Cessna 172 at 60 has Some Accomplishments Under Its Alternator Belt

OK, it is true that more pilots trained in a Cessna 172 than any other plane.  60 years of manufacture.  But, really? … 800 mile range, 140 to 185 mph?  I want one of those Skyhawks!

March 6, 2017

HOW Now?  The Examiner/PTAB Must Say How Combined Features “Obviously” Copy the Claims (in Hindsight)

I get this all the time.  The Examiner may find separate references for each element of a claim for an obviousness rejection, and then says “therefore” one of skill would be motivated in order to obtain the [hindsight] benefit of the combination.  In my Response, I note the failure of these conclusory rejections, and the Examiner only responds about half the time; requiring an appeal the other half. 

I was working on a Response a couple of weeks ago, where the Examiner said the combination of features would solve a problem (not even of record, nor raised in either reference) but did not identify how the first feature could possibly interact with the second one to provide the benefit.  I asked “HOW”?  It felt great to see the case in the article reiterating the Examiner and PTAB’s responsibility:

 "the Board nowhere clearly explained, or cited evidence showing, how the combination of the two references was supposed to work." 

The PTO has to take the features As They Are Presented In the References and show specifically how these particular features would interact.  This, without changing the principle of operation of the primary reference or change the function of the secondary reference feature.  It is not that complicated.  I believe most second year Examiners understand this, but many fake it for an easy rejection and a count in their quarterly count quota. 

AND, even if the combination COULD WORK, the PTO has to give a motive (absent hindsight), e.g., solving a problem of record, to make the combination.  I was working on a Response today where the first reference used feature 1 to solve a certain problem, and feature 2 of the secondary reference solved a different problem in a different field, and the Examiner suggested the combination could maybe solve a third problem not existing in the context of either reference. 

The strongest evidence of non-obviousness is if the Examiner cannot put on paper how the specific combined features could actually function together.   Thanks to the Federal Circuit - It is not obvious to solve a nonexistent problem, combining two features that are apparently incompatible with each other.   

March 2, 2017

Mixed Technologies for Success Against Cancer (CAR-T/CRISPR?)

Combination technologies are coming together to cure many forms of cancer.  A patient’s own T-lymphocytes can be engineered to express on their surface antibodies specific (or bispecific) to surface antigens common to cancer cells.  

In standard chimeric antigen receptor (CAR) Tcell therapy, there is a danger modifying the patients T-cells, e.g., with a vector that may randomly insert into cell the cell genome.  The danger of hazardous insertion mutagenesis can be reduced with expression vectors that replicate outside the cell genome.   One research group uses certain nonintegrating lentiviral (NILV) vector episomes that can express transgenes or silence targets.  See, https://www.cancer.gov/about-cancer/treatment/research/car-t-cells  .

Another breakthrough in the safety of Car-T systems should be combination with CRISPR/Cas9 technology.  The T-cells could be modified to surface express desired affinity molecules without the danger of random patient cell mutations. 

There have been some impressive success rates against intractable cancers.  The great thing about these technologies is they are so orthogonal to traditional techniques.  The cancer, specialized to survive chemo/radiation, can be caught by surprise unadapted (unadaptable?) to pervasive attack by roaming T-cells that hate them.   

http://www.businessinsider.com/ap-gene-therapy-to-fight-a-blood-cancer-succeeds-in-major-study-2017-2

February Entries:

February 22, 2017

UCB Loses the Patent Interference over CRISPR/Cas9, but So What. 

So ... the Patent Trial and Appeal Board (PTAB) deems the Broad/MIT claims to be non-obvious in light of generic CRISPR/Cas9 technology.  See exemplary patent and claims at https://www.broadinstitute.org/files/shared/osap/pdf/US8697359.pdf.  That is, the PTAB deems the Broad/MIT technology to be an inventive improvement over the pioneering UC Berkeley CRISPR/Cas9 technology. 

The Broad/MIT claims are essentially the generic UC Berkeley CRISPR/Cas9 technology only further limited to the context of eukaryotic cells.  This seems odd to me because it was "obvious to try" and multiple researchers were readily able to independently practice CRISPR/Cas9 technology in eukaryotes "without undue experimentation". 

I do not have all the facts, but ... it would seem reasonable if Broad could get narrow method claims to the specific way (e.g., a surprisingly effective transformation or vector system) of using CRISPR/Cas9 in eukaryotes.  Apparently, Broad did use CRISPR/Cas9 in both human embryonic kidney (HEK) cells and in an algae, using commercial transformation kits, and without unusual expression vector components.  They did this rather rapidly, apparently without running into any major problems to solve.  This seems per se obvious to try, and not inventive. 

In any case, there is a high probability UCB will appeal the ruling out of the U.S. Patent Office PTAB and into a Federal Court. 

The article has an interesting video about the CRISPR/Cas9 technology.  Check it out.

Again note that UCB will probably have a broader patent issued and will require even Broad/MIT licensees to pay royalties.  That is, as the article suggests, Broad/MIT may hold on to rights to green tennis balls, but UBC will probably have rights to ALL tennis balls.

February 21, 2017

Debunking the 9 Top Biotech Myths with New Irrational Myths. 

A biased and illogically self serving article, apparently with the intended goal of belittling biotech.  When the Author (he/she?, not attributed) must admit a benefit of biotech, the default comment is that biotech is still bad because the owners are trying to make money.  Further, biotech is not productive and no one wants it, but it is expensive and widespread (?).

In Myth 1, Author admits biotech products are not rejected in the marketplace.  But ...stupid farmers are buying them (even though they are useless and not productive - see points 2, 3, 5, 7, and 8).

2.  Author says: genetically engineered plants are patented and under private companies which makes them more expensive than indigenous crop for "third world farmers".  However, Author does not acknowledge the seeds may be more expensive, but not necessarily the "crops".  And, most biotech products are FREE to use in most developing countries, because they are not patented there.

3.  Author says the evil biotech is "largely profit-driven".  How bad is that.  I wonder if the author is making a profit.  I wonder if the biotech guys would be considered good if they were losing money? 

4.  The bad boy of biotech is Roundup Ready.  Research about Roundup toxicity changes with the breeze from year to year.  I avoid Roundup because it gives me the creeps.  However, it has toxicity so low that it has been hard to demonstrate scientifically.  In any case, this is irrelevant to the point championed in the article.  I know of no toxic biotech agricultural product - including the "Bt" protein noted in the article.

Myth 5 - Genetic engineered food can be better.  OK, you got me here.  However, Author suggests evil biotech "entices" people to buy GMO fruit by making them more desirable; again, so the selfish sellers can make money.  Bad.

6. Author suggests "weeds" take on biotech herbicide genes, as exemplified by allegedly possible transfers from corn to canola plants, neither of which is a weed. 

7.  Author suggests there are no economic benefits of engineered clops.  Again, that must be why GM crops are admittedly in such widespread use. 

8.  Author suggests biotech could increase plant diversity, but researchers are too greedy and will only make specialized crops.  Of  course, it is extremely expensive license one GM crop for sale, much less a variety of crops. 

9. In the last reasonable comment, the author admits that Bt corn pollen may or may not harm butterflies outside of a laboratory.  Obviously, the author is not biased. 

The article seems to admit to biotech potential, but assumes scientists are greedy bad people and will not use biotech for good.  Maybe this very good Author should show us all how to be a success, e.g., not making a profit without a patent while trying to license diverse crops that do not "entice" people to buy them. 

I am sorry to see this kind of negative propaganda has become so common in the media (apparently written by a journalist with no technical or Econ 101 background).  To make up for it, it seems the same "human interest" website also published an article highlighting successes of biotech: http://explorebiotech.com/10-outcomes-agro-biotech-improving-global-agricultural-sector/

February 18, 2017

USDA GMO Labeling Rules Delayed By Trump Rules

I can't say that more information is a bad thing, unless the receiving person has been intentionally confused about what the information means.  If I say a label saying GMO, I would buy it, just to support an over maligned, and broad brushed group of inventors.

Anyway, it is not clear that (President) Trump favors GMO, as much as dislikes regulations.

February 17, 2017

UC Berkeley Loses First Round.  PTAB Does Not Invalidate MIT CRISPR-Cas9 Patents

Well, this is the end of the first round in the MIT/UCB battle over CRISPR-Cas9 rights. 

I had previously suggested the outcome of this round may be that MIT would have the rights to the narrower claims of their mammalian embodiments. 

Still, there remains a high likelihood that the University of California will eventually have a patent issue with broader claims that encompass uses of the MIT patents.  That is, MIT (and MIT Licensees) may have to pay royalties to UCB to use a broader general patent covering any use of CRISPR-Cas9 technology.  And ... UCB Licensees would have to pay royalties to MIT, if they want to use CRISPR-Cas9 in the narrower field of mammalian embodiments. 

I guess UCB did not win the interference because the PTAB (Patent Appeal Board) believes it was not obvious to go from the pioneering invention of CRISPR-Cas9 to practice the more specific embodiment of editing DNA in eukaryotic cells.  This, even though UCB apparently presented evidence that researchers did in fact promptly practice the technology in eukaryotes without undue experimentation. 

There will be various appeals with UCB trying to show the MIT patents are invalid for obviousness in light of UCB technology.  However, the most interesting next event will be finding out the scope of the (broader?) claims that should issue from the UCB patent application. 

February 14, 2017

Who Makes the Best Planes?

Which aviation manufacturer makes better planes, Boeing or Airbus?  Depends on the definition of "better". 

It appears most of the differences, from the passenger's point of view, are under the control of the airlines, not the plane manufacturer.  The planes are good, from the airline point of view because they provide the flexibility to configure for maximum profit (best cost/benefit value to the customer?). 

As far as technology goes, it appears to be a dead heat between Boeing and Airbus with regard to efficiency and space.  New being better than old, in most cases.   

Good the competition keeps them both on their toes.

February 13, 2017

Patent Pools - the Friendly Trolls

These "patent pools" should be a great way to reduce transaction costs, reduce litigation, and reduce uncertainty - for both the potential infringer and for the inventors.

For the potential infringers (e.g., good people wanting to manufacture a complex product), the pools do not guarantee freedom to operate  - this is not actually "one stop shopping".  There will be other patents not in the pools.  However, the pools can significantly simplify analysis of the intellectual property environment around their product. 

The article does not discuss the benefits to the inventors who throw their patents into the pool.  They also get reduced transaction costs.  They can get value from inventions they may not even practicing, without the litigation costs of attorneys and Federal Court.

These pools are hardly distinguishable from "trolls".  That is, the pools are "non-practicing entities".  They must be ready to sue infringers of the patents in their pool.  Goes to show, if you paint a happy face on something, people like it better. 

February 9, 2017

Advantage USPTO - Better Prior Art Search Engine Than for the Rabble

Yes, the USPTO has an excellent prior art search capability through their Scientific and Technical Information Center (STIC) database. See article hyperlink, below. 

Too bad the patent search web site they make available to the public at USPTO.gov still lags behind.  Though it is a lot better (.pdf copies available) than 10 years ago, I believe key word searches are only available back to about 1978.  Worst yet is the lack of good old fashioned boolian search capabilities.  

Anyway, the article mentions that the STIC is available to the public at the PTO headquarters in Virginia.  I took a tour of the new regional satellite PTO office in San Jose a few weeks ago and noted that the STIC is also available there (and I assume other regional offices) just off the main entrance at an array of computer stations.

Wouldn't it be nice if the PTO would make this database available to the public through the internet, or at least to we elite registered Agents/Attorneys?

February 8, 2017

A Review of Ways to Climb Out and Descend Through a Planet's Atmosphere

This is a very interesting and exhaustive review of ways to leave and return to planets, e.g., depending on the amount of gravity and atmosphere. 

The giant Ragallo winged balloon was my favorite.  With a high surface to mass ratio, it begins slowing high outside the "atmosphere" without building up heat.  Finally, taking on a very high glide ratio (and lots of drag), steering to a home base.  Takes a long time to get down, but there are no difficult special materials required in the structure. 

The various tethers and rotating whips offer angles on lift and descent techniques I have never seen before.

Check it out. 

February 7, 2017

Kind of a Fluffy Piece on Joint Replacements

Sorry to say the article is not all that informative.  Golly gosh, knee replacements can be metal alloy, ceramic or plastic!  How is this a "factor" and what are the "considerations"?

Nice graphic of a titanium knee.

It is true the operation is super common.  There have been several among my family and friends (thank God with all the hiking I do, and sport accidents I have been in, my knees are pretty good).  Some replacements have gone poorly - bad range of motion and still plenty of pain.  Others got big improvements in life style.  Tha main correlations with outcome have been age and weight of the patients. 

Robots and custom 3D?  Seems, in theory, you should get a more precise result, for a better fit and shorter convalescence.  However, if they have not yet been able to generate good statistics to show differences over old technologies, the benefits may not be all that great.  Still, Experience counts (like in patenting).

The thing that always fascinated me was that the prosthetic joints can work at all.  They seem so foreign, without blood supply or membranes.  How do they keep clean, and why do they not irritate the surrounding tissues?

February 6, 2017

A Different Data Base Analysis of American Eating Habits - What's More and Less?

I found these American diet data interesting because they contradicted some information I had from other sources.  This data is not from questionnaires or consumption figures, but is based on calculations of food production minus waste estimates.   

I thought a lot of our present problems (diabetes, obesity, cancer, and heart disease) were from increased fast carbohydrate (sugar/white starch) consumption.  These data suggest sugar consumption is flat while fats and meat are up.  The big story, however, is that total consumption is way up.  That is the problem.

It would be worse, but we have surprisingly followed some of the recent suggested dietary guidelines.  We are eating more unsaturated fat and less red meat. 

They do not mention hydrogenated oils, but I suspect they are way down too; found only in ever diminishing packaged goods.  Sucrose is way down, overwhelmed by corn sugars, while honey languishes at the bottom.

What's up with that big spike in fat consumption in about 1999?  Was this when the low car/high fat weight loss diet craze began?

February 2, 2017

New Soviet (Oops, I mean Russian) Ground Effect Vehicle

Funny the article does not mention the Soviet era Russian experience with the giant Lun (Duck) class ground effect vehicle that trolled the Caspian Sea in the old days.  See: https://www.youtube.com/watch?v=V8Nu94khHoo

Another thing not mentioned is that a plane that can only hop up to 40 feet would not be too welcome or safe on land, but is well suited to "flying" over water.

So, what do we have?  A fairly slow aircraft that can efficiently carry heavy loads over medium distances of open water. 

February 1, 2017

Bispecific Antibodies Can be the Life of the Party, but Don't Call them Cheap

Chimeric antigen receptor (CAR) T-cell antibody therapy has had some successes, along with lots of the same old side effects you get with anything that causes releases of cytokines.  This expensive therapy requires patient autologous T-cells to be engineered to express cell surface receptors that redirect the T cells to a tumor antigen.  This is no simple task.  The receptor is complex with extracellular antigen-binding domain, a transmembrane domain, and a intracellular signal transduction domain; all of which has to be properly integrated into the T-cell membrane.   

But wait, wasn't this article supposed to be about the return of bispecific antibodies?  Yes.  They are coming back, as a less expensive way to get much of the benefit of CARs, and you also get the side effects.  The bonus is bispecific antibody treatments are half the price of the CAR theraphy.  The featured bispecific antibody links together B-cells to T-cells, to really get the T-cell mad. 

I don't know about you, but my vote is for the "trioma".  Let's see, an antibody that has three variable regions.   How about connecting the B-cell, and T-cell right onto the cancer cell antigen.  Now that is an awkward moment at the cocktail party; with the macrophages looking on (what wallflowers; at least they help clean up). 

January Entries:

January 31, 2017

A New Definition for "Side Slip" in Aviation 

This is one of the least flakey airplane seat inventions I have seen in quite a while.  Better than the bicycle seats and "spooning" seats. 

The wide isle during loading is nice, but the best part is probably the wider, lower middle seat with its own arm rests!   

What is the most anxious time if a commercial flight for you?  For me, way back in the coach seats, it is waiting for the crowd in front to exit so I can go.  These seats may save 5 minutes in boarding, maybe 2 minutes in exiting. 

Going in, all the side-slipped isle seats would be out of the way and not require much cooperation from other passengers.  Going out, we might all have a new gripe about the guy who walked off and did not slide his seat in. 

January 30, 2017

May Your Broken Bones Be Fixable

Well, the subject of fracture healing is one dear to my heart.  This is not a bad overview of bone healing and fixing devices.

I am very active and have been involved with a variety of aggressive sports and activities on wheels. In my life, I have broken 12 bones, including bones in each quadrant of my body.  When I got older, I thought only to kids break bones, but still, I broke my scapula and clavicle when hit by a car a few years back, and a rib when I hit a truck on my bike last year.  Bikes are dangerous.  I am not sure if I have broken more bones than my brother, who has ridden motorcycles all his life. 

The broken clavicle did not line up end to end, so is about an inch short now.  I was a little shocked when the surgeon at first said "I can't 'fix' this".  I didn't know "fix" is a term of art meaning align the bones for healing.  Finally he offered to install a plate to align the bones.  I asked him what is the difference between using the plate and not.  He said "the difference between a bump and a scar [misaligned bone or stitches]", and $3000.  I elected to let the bones heal naturally.  In any case, my modeling career is ruined.  

January 27, 2017

FrankenTree May Save American Chestnut

I grew up in Montana, so I know little of American chestnuts (we did have beautiful introduced "horse" chestnut trees in town, though). 

Here is a way genetic engineering can be put to good use as a tool to repair problems humans have introduced.  (I know ... what about unintended consequences?  Note, there are also unintended consequences of doing nothing.)

A gene to an enzyme that prevents oxalate build up in American chestnut trees can possibly eliminate the damage caused by the chestnut blight.  Have you seen oxalate crystals under a microscope?  Looks like a nest of knife blades.  Anyway, there does not seem any obvious unintended consequence to preventing an unnatural buildup of oxalate in a tree.  

I wish them luck, so that squirrels can once again travel from Maine to Ohio on tree branches (many chestnut) without touching the ground. 

January 25, 2017

FDA Empire to Expand Under Trump - GMO Animals are "Drugs" Requiring INDA

This article may be designed to scare us, but you never know to what extreme the new Executive Branch may take us.   

The FDA has published new Guidelines for review wherein a "drug (controlled under their regulatory empire) is any article “intended to affect the structure or any function of the body of man or other animals.”  Under the new rules, any animal "intentionally edited DNA" is a drug under FDA purview.  This includes, e.g., CRISPR modifications that are not transgenic. 

The Guidelins says "[a]n altered genomic DNA in an animal is a drug within the meaning of section 201(g) of the FD&C Act because such altered DNA is an article intended to affect the structure or function of the body of the animal".  As a new drug, intentionally modified animals seem all to be subject to FDA licensing procedures, starting with investigational new drug application (INDA) filing. 

See the proposed Guidelines at:

http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf  

This is pretty upsetting.  The Guideline at least allows the FDA to screen all new genetically edited animal to see if the change in the animal is likely to have a pharmaceutical effect.  At worst, it could require FDA licensing of all intentionally modified (traditionally bred?) animals.  For example, the FDA's authority over new animal drugs is said to come from the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321 et seq.). The definition of a drug, in section 201(g) of the FD&C Act, includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals”.  But the rule also includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

I worked in the pharmaceutical industry for many years and realize how much time and money it takes to get a new "drug" through the FDA regulatory scheme.  Taken to an extreme, as the new Executive appears, this could end almost all intentional adjustments of animals in the U.S.

Did anyone ever hear Trump suggest he would do this during his campaign?

The Guidelines are only "proposed".  Hopefully a loud outcry can stop this, or maybe an act of the new Congress[?].

January 24, 2017

Are Drug Patents a Curse on the Nation and the World?  

Dr. Pearl's article in Forbes suggests that "[patent] rewards for pharmaceutical companies exceed the benefits to our nation."  This may be true in a very small number of cases in the short run, but not for drug patents as a whole.  That is, the exceptions do not make the rule, as Dr. Pearl would have it.  

From a strictly Econ 101 point of view, if each side in a transaction does not think the benefit for them is greater than the cost, the transaction would not take place.  Maybe Dr. Pearl is simply suggesting the pharmaceutical companies are getting more than "their fair share" of the benefit of the bargain when selling patented drugs.  However, this also can't be true in the long run, since only mutually beneficial transactions take place while the patent is enforceable, and all benefit is eventually given to the public after the patent expires.   

It is notable that arguments like Dr. Pearl's are based on painting a whole industry as if all drugs fit into the odd exceptional cases that are hyped in the news.  For example, there have been three highly publicized drug price abuse cases in the media lately.  This, out of the thousands of drugs patented by hard working and risk-taking scientists.  Two of these cases were mentioned in Dr. Pearl's article. 

The price of Epipens was in the news.  Apparently, Mylan drastically raised the price of their trademarked Epipens.  However, please note that epipens have been around since the 1970's and the original patents expired long ago.  This is an example of the market place having a bad outcome due to a lack of competition, not the patent system's fault.  If someone else wants to sell epipens, or make patentable improvements of their own, on epinephrine administration, no one is stopping them.   The 5th branch of government (the Media - can you name the 4th branch? See below.) embarrassed Mylan and they have made some price reductions. 

Then there is the guy (now in jail, I believe) who bought the rights and jacked up the price to the toxoplasmosis drug Daraprim, mostly used by AIDs patients.  Again, this drug was long off patent (and probably would not have existed in the first place without the U.S. patent system).  The price went up because there was only one unkind supplier, not because of a patent.  Within weeks, an independent pharmaceutical compounder was selling the drug at a vastly reduced price.

Finally, there is Sovaldi , the new highly effective cure for hepatitis type C (HCV).  This drug has cured two of my friends that acquired HCV treating patients.  The initial price for a full treatment to cure was probably set politically too high.  However, no one argues that Sovaldi is not a cost-effective treatment (a little more than twice the cost of the old treatment regimen). 

Even if Sovaldi grosses more than $1 billion a year (with the U.S. market reducing as patients are cured) it would take some time to recoup the research, development, manufacturing, and marketing costs it took to develop Sovaldi.  Not to mention the much greater costs of the failed drugs the pharmaceutical maker paid for but never was able to license and sell.  Sovaldi makers have also been embarrassed by the media, and do offer discounts.  And, at some point, this patent will expire.  I assume there are no patents to this drug in most of the world and it is already a gift to humanity there now.  Another huge benefit not discussed is the future benefit of Sovaldi - people who will not ever get HCV not passed on in the future by cured patients. 

Assume half the drugs developed in the U.S. would never have been developed without the patent system  - a conservative estimate in light of the known poor productivity of countries without effective patent systems.  For example, how many drugs in the world's pharmacies were originally developed, e.g., in the old Soviet Union?  Should we trade the immense legacy of patented drugs in exchange for never having aone or two drugs overprices for a few years?  Most drugs were patented at one time but the patents are expired and dedicated as a gift to the public.  

Can it be said that the nation does not benefit from pharma patents?  Can it really be said that pharmaceutical companies in general benefit more than the nation from pharma patents over all?  Profit margins on pharma are in line with other risk taking businesses.  What is the benefit margin for, e.g., a cure, or prevention of HCV?  How much have pharmaceutical companies lost trying to find a cure for HIV?  Will the cure "benefit the nation" less than all those who have worked on HIV for decades? 

Does the motivating reward of patents, and the long term (forever) donation of the inventions to the public after patent expiration provide a net benefit the nation?  Just because of rare instances of overpriced drugs in the news does not make it smart to, e.g., end patenting of drugs. 

4th branch of the U.S. government is the States. 

January 23, 2017

Fluorinated Nanotube Surface for Medical Implants Repels Blood and Platelets

The hydrophobic material, in combination with a topography having mostly large contact angles prevents agueous solutions from wetting the surface.

What makes me nervous is the spaces where bacteria could hang out.

January 22, 2017

Substitute Teacher - Freeze Dried Nanoscale RBCs

I have seen blood substitutes (oxygen solvents and hemoglobin based constructs) come and go.  This one seems different. 

It is a 0.3 um biconcave nanoparticle (RBCs are 7 um) with a trilayer (phil/phob/phil) capsule around hemoglobin (Hgb).  These particles ares small enough not to be sequestered in the spleen, and no free HGB to be taken up by the liver.  Apparently, there are no severe side effects, compared to the oxygen solvents like perfluorocarbons.  (Anybody remember the Dow chemical TV commercials in the 80's where they had a mouse immersed and breathing the stuff?)

The patent application is 2016/0346358, with an initial claim directed to:

"a nanoparticle having a substantially bi-concaved disc shape, wherein the nanoparticle comprises an aqueous core, a bi-layered shell comprising an amphiphilic polymer, and a payload comprising an oxygen-carrying agent, an allosteric effector, and a reducing agent ..."

See at this URL (click "images" for pdf view):

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20160346358.PGNR .

January 21, 2017

PreAppeal Review Conferences (PARC), A Walk in the DARC? 

I have used PreAppeal Review Conferences (PARC) on several occasions.  I consider them a useful tool, but there are problems not mentioned in the article.  See the article PARC is Winning Strategy

The article suggests that use of PARC "correlates" with higher success on Appeal.  I am glad they said correlates, and not "causes".  I love people with technical backgrounds (we ought to all get into politics).  

I use PARC when the Examiner's rejections are so unfounded as to embarrass them in public.  The PARC committee is supposed to be the Examiner, his SPE, and a SPE/QC Specialist from outside the Examiner's art group.  The Examiner has to defend the rejection to two staff members with more experience.

The benefits of the PARC are is it free and has the potential to advance prosecution.  Prosecution is suspended until the PARC Decision is issued, e.g., with a two-month deadline to make your next move.  You are supposed to get a disinterested third party on the Committee to review the rejection(s).  The Brief filed for the PARC is a good start on an Appeal brief, should the Decision not go your way. 

There are two major problems with PARC.   

1) The Decision is only thumbs up or thumbs down. The Decision does not discuss the PARC proceedings or the basis of the judgment. When I file for a PARC, I always ask that a "reasoned finding" be included with the Decision, but I only get one about a quarter of the time. If I don't get a reasoned explanation for the Decision, I will usually call the Examiner and ask for an explanation, and can get some information about half the time. It is hard to make progress without information.

2) The Decision goes against Applicant if there is "one or more issues remaining for Appeal". That is, if there are 5 different rejections, and the PARC agreed with you on four of them, the Decision goes against you. And ... as above, the Committee does not tell you how many or which issues they found in your favor or not. Doesn't this seem unreasonable and unproductive? I have tried to get around this by only arguing my strongest issue (objectively in my favor and should require an allowance) in the PARC brief. I was blown away to have the Decision go against objective facts.  Sadly, the Review Committee could hide behind the lack of a requirement to state the rationale. (I also noticed in that case that the third PARC committee member was a SPE (friend?) in the Same Art Unit.)

I am using PARC less now, but did have several productive PARC filings.  I found it humorous that the "allowances" in the article included allowances in the PARC Decision (scarce as hen's teeth) PLUS allowances after a new non-final Office Action.  I have had several of these.  Instead of allowing the case, the Examiner gets additional counts on his record for issuing a new non-final Office Action (e.g., citing cumulative prior art, subject to the same counter arguments) before issuing the Notice of Allowance. 

So, PARC is like a walk in the park, but you are blindfolded, don't know where you will end up, and certainly not how you got there. 

I think the Post Prosecution Pilot program (P3, now cancelled) was probably designed to address some of the issues I raised above.  The P3 was like a PARC where the lowly Applicant could participate.  I wonder why they terminated the P3 program.    

January 20, 2017

Another Artificial Heart Strategy

This seems like a great idea, Soft Robotic heart support. 

First thing that came to my mind is the same old problem - how will it be powered.  The first artificial heart (Jarvik, 1982) totally replaced the failing heart with an air driven bellows.  But only with the patient attached to a huge pump and controller.  Sheesh, that was 35 years ago. 

The heart uses 7% of the energy in the body (1/3 as much as the brain).  I see references suggesting the heart output is only about 2 Watts.  Even with inefficiencies, a power supply might need only 10W.  Maybe modern batteries can make mobility practical with a soft robo heart.  

January 19, 2017

Classic Cars in China

Here is a article about classic cars where you wouldn't expect to find them. 

Seems like some Chinese are more equal than others. 

January 16, 2017

SSJ Boom Article With More Than Fluff

We have all probably seen fluff articles about the new "Boom" supersonic jet (SSJ - I guess they don't call 'em SSTs anymore).

Anyway, this article is not half bad.  Gives more information than a lot of the articles. 

This Boom group seems to be ahead of the several other consortiums wanting to tap into the market for 3-hour trips between London and NYC. 

The Baby Boom proof of concept jet will 1/3 scale and still use three military grade turbojets.  There is variable geometry throughout the plane to deal with the different conditions between the taxiway and mach 2.2.   

Initial Baby Boom tests will be in the supersonic corridor over Edwards AFB in California.  This is far from my place and I have flown over it many times.  I would love to see (and hear) it go by.  I remember, as a kid in Montana, the Air Force would fly supersonic and there were booms all the time.  I liked it.  Once, I was "camping" out on the front porch of my house with a friend and I remember seeing a light zooming across the sky real fast.  I thought it was a UFO. It passed silently straight overhead and on to the east horizon.  Then ... finally, there it was.  The Boom.  For years, I still thought it was a space ship, but it was probably an F4 phantom, maybe heading back to Malstrom AFB. 

I think there is probably a viable market for supersonic flight.  Do you know how much it costs to fly NYC to London, even business class, much less first class?  This is essentially for a little more leg room and to get out of the plane 10 minutes sooner.  Seems the Boom SSJ could siphon off some of the high rollers wanting to do another 800 kts, and still get the leg room.  The project does not seem crazy.  Competitors with other SSJ projects seem to be at less advanced stages of development, but think they can make money. 

Making a supersonic aircraft is old hat now days.  Too bad there are a lot of other political hurdles that I suspect will be the greater challenge for a success in SSJs.

January 14, 2017

Pan-Resistant "Superbug" Kills Patient in Nevada

A little snippet on another Superbug.  Has at least a lactamase and resistance to tetracyclines.  Who knows what else. 

Originated in India, apparently.  I remember, the first time I was there, any pharmaceutical was available at the local drug store without a prescription. 

Maybe we should send Batman vs the Superbug.  Don't tell me how it turns out, I haven't seen the movie yet. 

Well, the article didn't even say the species of the bacteria (Kleb. pneumo).  See more information at:

https://www.cdc.gov/mmwr/volumes/66/wr/mm6601a7.htm?s_cid=mm6601a7_w

January 13, 2017

Blocking Patents Count - Facts Starting to Come Out in CRISPR-Cas9 Ownership Controversy

As one experienced in patenting pioneering inventions would have expected, the huge patent applications of the CRISPR gene editing ownership controversy include a variety of separate inventions. This has made the opening salvos in the University of California vs Broad (MIT) CRISPR interference proceeding somewhat complex.

See article at: Biotech Patent Dispute 

[An interference proceeding is a case where a first inventor amends their claims to copy the claims of a junior inventor, forcing the Patent Office to determine which party was first to invent and has the right to patent identified technology. This procedure will eventually expire because newer cases are governed under America Invents Act first to file rules.]

UC was the first to file an application. Broad filed later but has patents already because they used an accelerated patent prosecution procedure at the Patent Office. One interesting question may have already been answered. That is, UC seems confirmed as "first to invent" CRISPR-Cas9 because Broad could have challenged with documents showing their invention of CRISPR-Cas9 before the UC filing date, but Broad has not done this.

As Senior party, UC is challenging the issued Broad patents. If UC can show that Broad was not actually the first to document the inventions in the claims, the Broad claims would be invalidated. The question at this point is essentially - to what extent does the earlier work of UC disclose, or at least render obvious, the Board claims (particularly the aspect of using CRISPR in eukaryotes).

Of strategic importance, at this point, is what are the representative Broad claims ("counts") that the Administrative Judge (Dr. Deborah Katz) will review as possibly first invented by UC? Judge Katz has suggested claims in the context of eukaryote biology (where much of the expected utility $hould be). The UC reduction to practice and Examples in their patent application focus on the context of prokaryote biology, but the UC application does envision  eukaryote concepts.

Broad says the interference claim (count) should be directed to CRISPR-Cas9 systems in eukaryotes; saying this was not obvious (was an inventive contribution to the art by Broad/MIT). UC says the considered interference claims should be directed to systems wherein the targeting sequence and Cas9 binding sequence are both on the same single stranded RNA (making UC clearly the pioneer, and Broad suggesting this is obvious).

Blocking patents:

I) It seems to me that there is little argument that UC was the pioneering inventor of the basic CRISPR-Cas9 system. Even if Broad is deemed to be the first inventor of the system in eukaryotes, it seems they would be blocked from practicing their own invention, e.g., having to pay license fees to UC to use the generic CARIPR-Cas9 system. And, for UC (or their licensee) to practice the technology in eukaryotes, they may have to negotiate a license with Broad (if the Judge decides the eukaryote technology was not obvious in light of the UC invention).

II) If the eukaryote invention is supported by the UC application, and the idea is obvious in light of the prokaryotic system, the Broad patents would be declared invalid in the Interference. UC would own it all. In a strange twist, it is possible that the eukaryotic invention could be deemed obvious and unpatentable by Broad, while UC could not patent it either because the UC application may be considered to inadequately describe or enable eukaryotic systems (based on section 112 written description and/or enablement rejections). This may not matter to UC, since eukaryotes are a species of the genus they would control. And no one could get a patent for the eukaryote aspect since the UC and Broad prior art would render the idea old and obvious to new applications.  

III) If the Judge agrees to review the count involving the single stranded RNA embodiment, UC would again control a pioneering claim best mode claim; ownership not disputed by Broad.  

What might happen? I expect US would be considered as first to invent single RNA systems and the generic CRISPR-Cas9 systems. The main question is who was the first to invent (or at least render enabled without undue experimentation) a eukaryotic system. Broad may be shut out if UC enabled the eukaryotic system. Otherwise, Broad could own eukaryotic CRISPR-Cas9 systems, but have to license the generic system rights (and the single RNA aspect, if desired).

Determining whether an invention is obviousness (or enabled) can be highly subjective and unpredictable the realm of patent validity. There is no guessing whether Judge Katz will find the eukaryotic system obvious; or if UC would ever be able to prosecute allowable claims directed to eukaryotic systems.

Then there are the 50 pound gorillas in the rafters. Neither UC nor Broad disclosures discuss apparently better CRISPR systems interacting with proteins other than Cas9, such as the Cpf1 that does more than delete specific DNA sequences by enablings replacement of one DNA sequence with another.

And ... the Interference is not the end of the line, with appeals to higher Courts a certainty. 

ShareShare Blocking Patents Count - Facts Starting to Come Out in CRISPR-Cas9 Ownership Interference.

January 12, 2017

New Decision Makers are Changing the Priorities for Drug and Medical Device Development 

With changes in the overall health care system, priorities in medical technology are evolving.

Traditionally, medical doctors have been the key decision makers in the choice of drugs and medical devices for patients.  Now, with the focus on keeping costs down, and with hospital management making more decisions on standard treatments, investments in research and start ups are appropriately evolving.  Cost-increasing physician choices are starting to take the back seat to cost saving, favorable outcome, and safety enhancing decisions.

I found the SteriPath device interesting ( http://www.magnolia-medical.com//a> ; patent at https://www.google.com/patents/US8197420 ).  When I was a staff Medical Technologist at Stanford M.C., blood cultures required extensive procedures and time.  There were multiple cleaning and sanitizing steps before the skin was pierced.  Typically, we would first take samples for other analyses, of take a small tube for disposal, before taking the sample for blood culture.  Still, if we came up with S. epidermitis, we would consider the sample probably negative (false positive).  Seems this SteriPath device simplifies the procedure. 

So, we are now on the path to reduce false positives, increase safety, and reduce the cost of drugs and medical devices ... finally, the cost of medical care will go down.

January 9, 2016

Progress in Cancer Reduction and Treatment

Good news in cancer rates and deaths reduction. 

The success in childhood cancers (mostly leukemia - that killed my same age cousin when I was a kid) seems to mostly be due to huge improvements in treatment. 

Improvements in adult cancers seems to be mostly lifestyle changes (not that our society is losing weight, but at least not smoking).   

Thyroid and some skin cancers are relatively easy cures.  Lung and prostrate are devastatingly difficult.  The big ones remain breast/prostate, lung, colorectal.

Anyway, with improvements in cancer and heart disease treatment, we may eventually have to die of Alzheimer's or accidents (not funny). 

January 5, 2016

Amazon 1-Click Patent to Expire. 

Goes to show, the patent system does have some benefits.  Imagine, if Amazon had not "invented" one-click shopping, no one in a hundred years would have thought it up and we would all still be stuck at 2 or more clicks.    

I always thought one-click purchasing claims were invalid as obvious over prior business practices, wherein you push a button. 

Personally, I never use 1-click because it makes me nervous.  What was the tax and shipping?  Which of my payment methods did it use?  Was it even the product I intended to buy?

Now, it is one-click for all, and all for one-click.  This is so exciting. 

January 4, 2017

SR71 Radio Call

I couldn't resist posting this one.  Got quite a chuckle. 

I believe I have registered a 180 ground speed in a Cessna 172 - down wind at altitude, of course.

January 3, 2017

Recent Gene Therapy Advances, in Review. 

This is a good review of gene therapy progress, including hyperlinks with more information on specific technologies. 

Could it be that the promises of genetic engineering to cure diseases may finally be coming true? 

Monoclonal antibodies failed miserably in the '80s, now they are having some succeses. 

CRISPR has the potential to cure a wide range of diseases including gene malfunctions, cancer, and viral diseases. 

The problem is, though, the "one is done" scenarios fail to motivate innovation.  This had long been a problem with vaccines, until the government stepped in, at least reducing the liabilities of marketing vaccines. 

Imagine, if you spend 10 billion dollars on a drug (basic research, development, manufacturing, licensing ...) and only 1 in 10 of the drugs make it to market, and you can sell only one dose per patient for a cure.  Then, if there are one million patients with the affliction, you have to charge at least $100,000 per pill, just to break even.  Do you want to start a business taking this risk? 

On the other hand, I did not realize that the periodic doses of Factor VIII treating hemophiliacs could cost more than $200,000, a year.  Looking at cost/benefit ratios, a pill curing hemophilia would be easily worth $1,000,000, but the media would hate the company selling the pill. 

December Entries:

December 29, 2016

Private Individual Builds 2 Airplanes a Second

Looks like most of those airplanes needto have their elevators trimmed.  

December 28, 2016

In Europe Quality is Consistency of Claim Rejections, Not So at the USPTO

Obviousness is the heart of both U.S. section 103 ("obviousness") rejections and European "inventive step" rejections.  The article suggests that the reason European patents are of better quality is because of the more objective and consistent obviousness review using the problem/solution analysis. 

I agree EPO quality is better ... if quality is consistency (but not necessarily fairness).   I believe there are other reasons U.S. patents are less consistent in the evaluation of obviousness (and other patentability issues, such as novelty, written description, and enablement). 

In the U.S. obviousness is ultimately (at least on Appeal) controlled by comparing holdings of controlling case law to the particular facts of the application.  For example, the famous KSR decision found it obvious to combine structures from prior art references to copy the claims, as long as the structures retained the same functions in the combination as the references.   

The biggest contributors to inconsistency in the U.S. system are not mentioned in this article.  The Examiners are not attorneys, they are motivated by a points ("counts") system, and they are judged on their individual decisions by those above them. 

Examiners (Executive branch of government) are not attorneys so tend to ignore controlling case law (Judicial branch).  In the Manual of Patent Examination Procedure (MPEP) Examiners find key words in short quotations from Court cases, then interpret them to suit an obviousness rejection (often where the Court case actually found the claims non-obvious).  Examiners never actually read a Court case to see the full set of facts leading to the decision.  And, with limited facts, Examiners reject inconsistently.  In Europe, they do not seem to use case law fact analysis at the Examiner level.

Every 3-month quarter, Examiners are required to meet a quota of "counts" they obtain, e.g., for issuing an Office Action (rejecting an application) or "disposing" of a case.  At the beginning of a quarter the Examiners are tough on Applicants.  At the end of the quarter, Examiners are often in a rush to get counts by interviewing (e.g., cold calls to Applicant's representatives) and even offering Examiners amendments to allowable claims.  The Examiners are inconsistent in their actions depending on how many counts they have and what time of the quarter it is. 

In Europe, being one vote out of three Examiners on an allowance committee puts much less pressure on the individual Examiners.  It also puts peer pressure on the Examiners not to argue clearly self-serving crazy rejections.  In the U.S., the individual Examiner must defend an allowance (but not a rejection) to more senior personnel.   

Allowances at the USPTO were way down several years ago when it was apparently policy not to have "false positive errors" of allowing an invalid patent (I heard it was grounds to be fired).  There is still a lot of pressure not to allow cases with any patentability question at all. 

So ... I occasionally run into obstructionist Examiners who make up clearly erroneous rejections, to get their counts and avoid having to defend an allowance.  I have one Examiner who has a bunch of templates for different types of inventions and routinely sends out 100 page Office Actions rejecting on every possible ground.  He almost never allows, and many small inventors must give up in the war of attrition and give the Examiner a count by abandoning their application (note, he almost always loses on Appeal).  This would almost never happen if a group of three Examiners were reviewing the case. 

With the present structure of no peer pressure, union protection, and perverse motivating counts, severe inconsistency can result.  In many art units (Examiner technology categories), the biggest variable influencing allowance of your case is what Examiner handles your case. 

Inconsistency in obviousness rejections and allowances is greater in the U.S. for many reasons.   The USPTO Examiner corps is a great group of hard working intelligent people, but the current organizational structure generates inefficiencies and inconsistencies that must result in a lower quality than at the EPO (not that the EPO does not have some irrationality, e.g., in the realm of amendment subject matter support rejections).

December 27, 2016

Ebola Vaccine Yay!

Because passive immunization with ebola survivor serum seemed to be helpful in ebola treatment, there was hope that a vaccine could help conquer ebola. 

I guess it took the fear of spread to developed countries to prompt development of an ebola vaccine.  It was creative how the investigators took advantage of the last stages of the recent outbreak to get their clinical data. 

The vaccine uses a replication-competent vesicular stomatitis virus-based vaccine expressing a surface glycoprotein of Zaire Ebolavirus (rVSV-ZEBOV).  This presentation must be quite immunostimulatory.  See the article on the vaccine proposal from 2015:

http://www.thelancet.com/pb/assets/raw/Lancet/pdfs/S0140673615611175.pdf

December 23, 2016

Intraperitoneal Infusion of Amniotic Stem Cells Strengthens Bones
 
I thought this article was going to be about grafting of stem cells that help directly build bone structure.  Instead, it seems to be about stem cells signaling resident cells to build better connective tissues. 
 
Amniotic mesenchymal stem/stromal cells (AMSCs) are said to be universal allogeneic donors.  The cells are selected from amniotic fluid based on the presence of release mast/stem cell growth factor receptors (SCFR), also known as proto-oncogene c-Kit. 
 
Infused into mouse peritoneum, the AMSCs appear to migrate and take up residence throughout the body.  The odd part about this study is that the mouse model is a "brittle bone" mice with a collagen mutation.  I am not sure this model is representative of a human osteoporosis patent. 
 
Anyway, the infusion of AMSCs resulted in a general stimulation of osteoblasts and other signaling that improved many bone parameters, such as reduced breakage. 
 
Who knows what other general improvements (defects?) these cells provided regarding mesenchymal origin cells throughout the body. 
 
See the full article at:
 
http://www.nature.com/articles/srep39656
 
There is a lot of work being done lately on reconstruction of connective tissues. 
 

December 22, 2016

Are You Curvy or Square?  Car Shape History

Fun video to watch, but they never actually explain why cars went from round body parts in the 30's/40's to squared cars in the 60's/70's. 

I imagine it was the "jet age" styling, and the fact that the sharp panels were easier to stamp and were more rigid. 

People have said my 240Zs look streamlined, but they are not.  Lots of air goes under them, the headlights are flat and the long hood does not taper up into the wind screen.  An after market front air dam and rear spoiler do help some. 

One problem I have heard a lot is that the wind tunnels have made all the cars look alike.

December 21, 2016

Canberra Flight Altitude Record Setter to be Restored

I had heard that the Canberra (first British jet bomber) had set flight altitude records in the late 50's, but I always thought of them as having more glider-like wings (like a U2).  These wings seem almost stubby with a pretty thick chord. 

Anyway, they set several records and had a very long active duty life.  It is good they still have the original in condition repairable to flight certification. 

December 20, 2016

Cartilage Repair Using Autologous Mesenchymal Stem Cells

It appears that this method uses stem cells from the patient's own bone marrow to generate tissue repair cells (TRCs) that go into a matrix for filling in lost or degraded cartilage. 

According to the claims in a Vericel patent, the composition is high in CD90 positive cells (adhesion-associated stem cells), particularly with hematopoietic, mesenchymal and endothelial lineage.  The remaining cells are CD45+ (leukocyte-associated).  The composition included a biodegradable polymeric matrix.  The cells of the patent claim must an anti-inflammatory cytokine or angiogenic factor. 

See the 9,415,071 patent at:

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9,415,071.PN.&OS=PN/9,415,071&RS=PN/9,415,071

(Press "images" to see .pdf version.)

Claim seems to leave open reverse engineering, e.g., wherein there are cells other than CD45+ and CD90+ cells present. 

I wonder if there is any cross-linking of polymers or growth of collagen from the cells before this material is implanted for cartilage repair.    

December 19, 2016/p>

Some Mental Exercise Concerning IFR Partial Panel Choices

My first thought was that the choice of flying an arc over procedure turns would depend on the aircraft and equipment on board. 

December 7, 2016

Abstract Plus Physical Equals 101

When the patent eligibility rejection is based on an ineligible abstract idea, this case shows that a there should be eligibility if the claim can not be practiced in the abstract.  Add "something more" physical to the idea, and the PTO should have to move on to more substantive review. 

How about algorithms?  Add something physical ...?

How about a natural substance?  Hmmm, maybe add an abstract idea.   Seems biotech is in more of a bind (unless the Examiners read the recent more lenient guidelines).  The something more has to be something inventive (non-obvious) and not preempting the field.  Not using the substance, but maybe using an antibody against a particular epitope on the substance.   

Never thought I would see the day the case law seemed easier on software than biology. 

December 6, 2016

Medical Device Patent Protection 

Mr. Harris presents a good overview of issues around patent protection in medical technology.

I agree whole heartedly that you need a "rich disclosure" in your original application.  You can only amend claims (to get around rejections) based on descriptions in your original application supporting the amendments.  The application descriptions must be written by a professional - I have only seen one good patent application drafted by a Scientist in my entire career.  A patent specification is not a journal article. 

I also agree that it is important to "make friends" with the Examiner.  That is, I naturally get along with people and the Examiner is not an adversary.  Getting on the phone with the Examiner can make all the difference in obtaining cooperation and suggestions leading to claims deemed them allowable by the Patent Office.

It is true that the Examiner almost always rejects all claims in the first Office Action (a perverse result of the "points" system used to rate Examiner productivity).  However, in my practice, rejections are often overcome not by amending (and narrowing) the claims, but by making fact-based arguments (based on case law precedent), e.g., showing that the combination of references is NOT obvious.  For example, it is not obvious to combine a feature from a secondary reference in a way that requires the primary reference to change its principle of operation, or to employ a feature from the secondary reference functioning in a way not described in the reference. 

Also note that the Examiner's first Office Action often comes more than 2 years after you have filed the application, but there are procedures to request expedited patent prosecution.

December 5, 2016

Huge New Orders for Boeing 4th Generation Fighters 

I guess the rise of Iran lately has put quite a scare in Qatar and Kuwait.  F15s and F18s are ominous aircraft and can still hold their own against most fighters, if they see the opponent first (or end up in a dog fight).  

What is Good for Boeing is Good for America!

December 4, 2016

WoW! New Sugar - Reformulated to Not Go Into Your Stomach!

When you eat a candy containing hard crystal sugar or caramelized sucrose, a lot of the sugar goes straight into your stomach without you actually ever enjoying the flavor in your mouth. 

The article is mysterious, but I suspect the "new sugar" is sucrose processed to present a higher surface to volume ratio (maybe in a matrix with another substance?).  This way, in the short time the candy is in your mouth, you enjoy the taste of more of the sugar.  Thus, more flavor for the same calorie burden.  Not a formulation, but a structure.

I believe the journalist did not have a clue what he was talking about.  Not a new sugar, not reformulated, not tasted without ending up in your stomach.   

What do you think? 

December 3, 2016

Steel Stealing Cobalt From Tesla Battery Gigafactory

Electric car batteries use more cobalt than lithium.  The problem is, there is a very limited supply of cobalt and no reasonable way to ramp up production.  You can't squeeze blood from a turnip and you can't squeeze more cobalt from current sources.

I am sure Tesla thought of this.  Maybe they think they can pay a higher price to get supplies away from steel producers and such, but the other cobalt users receive high value added for their cobalt use and have inelastic demand.   

The solution, as with all problems, must be improvements in technology.  Maybe Tesla knows of a promising a new electrode formulation replacing cobalt with iron (fat chance!).

December 2, 2016

Sorry, But Another Article About Supersonic Jet Startups

Another supersonic jet article with a lot of talk about end results but not about HOW to get there.  

Most agree (besides noise problems) the big deal is engines to produce economical fuel per person mile results.  The only specifics I saw was to take an established turbofan engines and make the fans smaller.  Can this work?  Can you go 2.2 Mach on a low bypass turbofan?

Hoping for 3x the fuel per passenger over 0.8 Mach flight may not be the most environmentally consciences approach (Sure.  They will run on vegetable oil.)

Should be OK, though, as long as the businessman gets home in time to tuck the kids in bed.  

December 1, 2016

WIPO Wants to Protect Traditional Knowledge - From What?

How do you "protect" traditional knowledge (TK) and what is the damage if it is not protected.

It is clear that public information is public.  It is clear secrets are secrets, and non one is forcing anyone to divulge.  Natural phenomena and substances are not patentable, so can't be stolen. 

So what is not protected?  What are the harms to be avoided.  The article actually does not say. 

If knowledge is old, anyone can use it, as the heritage of mankind.  At this point, vaccines are TK in the West.  Should we protect them?

November Entries:

November 31, 2016

Test Kitchen Trade Secrets Stolen? When They Got there, the Cupboard Was Bare

My wife and I have been scientists.  We like to watch America's Test Kitchen (ATK) because they experiment with recipe variables to determine what is important and not in improving food we cook.  They try to explain some of the science behind the recipe results (but, if I have to hear one more time about forming gluten or the Maillard reaction, I will lose my apatite). 

Apparently, the long-time host Chris (with the bow tie) left the show last year.  He was divorced, then married one of his assistants (also a defendant) from the show more recently.  See the scoop in the pleadings:

http://tsi.brooklaw.edu/sites/tsi.brooklaw.edu/files/filings/america039s-test-kitchen-v-christopher-kimball-et-al/20161031america%E2%80%99s-test-kitchen-sues-former-host-misappropriating-tasty-trade-secrets.pdf

Before he left ATK, Chris apparently received some data such as his contact list and some recipes (developed during the show).  He had not signed a non-compete clause in his employment contract, but it seems his new wife had.  Chris left ATK to start a new show he had already developed. 

Reading the allegations in the complaint, they mostly seem circumstantial, and even immaterial to the issue of Trade Secret misappropriation.  So what if his new show has a lot of features similar to ATK.  These are generally known public features (science, gadget reviews, recipe problem solving) that are apparent by watching the show.   

I don't know about Massachusetts law, but in California the law favors the departing employee.  The most embarrassing aspect for Chris is the accumulation of data from the work files to his home files just before leaving.  A lot of this data was probably in his memory or publicly available, but he probably considered it a part of "his" creation and property as one of the ATK founders and senior executives.  However, much of this information was probably not generally available and had economic value, thus subject to trade secret protection. 

The plaintiff (ATK) wants a preliminary injunction to prevent use of any trade secrets.  I like the fact that plaintiff plead so many specific facts.  However, it is not clear to what extent the data taken by Chris was trade secret, and  up to this point it does not seem there are any damages.   

An entertainer can take his good will with him when he leaves a show, and even play similar roles in similar shows.  Seems most of the allegations are not actionable, but there are some allegations that would not look good in court.  Too bad Chris made this difficult by leaving such an e-mail record of data transfers on his way out. 

November 30, 2016

New HIV Vaccine Trial Hoping for at Least 50% Protection. 

I saw an article in the general press about the new HIV vaccine trial.  Had to look around for an article with more scientific details (see hyperlink).

Apparently, a big part of the three antigen vaccine cocktail is a couple of GP120 antigen subtypes.  Brings back memories.  At my first biotech job in 1985, I synthesized a GP120 polynucleotide on a home made DNA synthesizer. Later, at Chiron corporation, we had a GP120 vaccine that was ineffective. 

Seven years since the last vaccine trial.  The current trial uses some elements of the previous partially successful trial, with more antigens, adjuvants, and doses.  The goal is better than the previous 30% protection rate.  At 50%, they might actually get people to use the vaccine. 

Then, there are the issues of other HIV subtypes in other regions of the world.  Best of luck.

November 29, 2016

I Can't Resist an Article About GMO (I Mean GEO) Bananas

Interesting article showing a wild type banana.  Seeds used to be abundant, large, and hard. 

Bananas are reproduced by cutting "pups" from rhizomal root shoots.  I worked on a banana farm once.  While I was in the field working, I was told to kick and kill the "spears" (male pups identified by their thin and pointy leaves) because they were unproductive.

I have heard bananas are the biggest crop in the world, but they are mostly eaten where they are grown (in village back yards).

Ok.  By genetic engineering (not bad genetic modification) bananas have been developed expressing extra vitamin A.  I hope "golden" bananas fair better than golden rice did.  Hopefully, the golden bananas taste good and are resistant to pests.  Hopefully they will not be rejected by farmers so they can save lives and eyes. 

November 28, 2016

Mazda Rotary Engine Finding a New Niche

I still drive Datsun 240Zs ( www.biopatent.com/cars.html ).  They won the Sports Car of America Championships 4 of 5 years in the '70s.  The year they did not win, it was a Mazda RX 7 with a rotary engine that won.

The RX 7 was no tire burner (nor was the 240Z); low torque, but a lot of horse power in the high revs, was light weight, and had a low center of gravity. 

The rotary engine has a great power to weight ratio.  And, the cross section of a rotary engine looks so cool.  Too bad it is so difficult to do a good job sealing the combustion chamber (engine life) and getting discrete gas exchanges in a valveless rotary design with odd quench zones engines (smog issues). 

 I think it is a great idea to have a small gas burner in electric cars.  It gives more confidence out on the road, and can avoid some of the long recharge times, in a pinch.  A rotary engine is perfect in that role, especially if it can be upgraded to meet modern expectations.  

November 26, 2016

Positive Trends in IT/Bio Patent Claim Eligibility

This article is a good overview of the current state of patent eligibility. 

I'm not sure how long this will take to filter down to the Examiners.  I have a couple of cases on Appeal with section 101 arguments.  Maybe the Examiner's will at least get past conclusory (fact-free) rejections if we start winning some Appeals based on recent interpretations of patent eligibility by the Courts and PTO Guidelines.  Change is slow, because no examiner wants to be the first in their Group to break new ground allowing cases (never a problem with rejecting cases).

So.  If the claims are not monopolizing the algorithm/natural phenomenon, and are not "directed to" it, then the Examiner should get on to prosecution on the merits.  The invention is not directed to the ineligible subject matter if the "something more" in the claim is inventive in its own right. 

November 22, 2016

Successful Drug Companies to Subsidize Unproductive Governments

The authors are not totally wrong, but terribly one sided. 

Most drugs are not patented in poor countries.  So, they are free to make, and even import, most drugs, even when they are still on patent in developed countries. 

Many drugs may be patented in South Africa.  South Africa is a big boy now and should be able to play fair.  Taking the intellectual property (drug inventions) from the drug companies may be viewed as theft from the companies and countries that spent billions developing the drug (that never would have existed, and will be given to the world public when the patent expires).   

The drug companies have their profits (and losses in failed research) and the governments have their taxes. 

Consider this - if South Africa wants cheap drugs for their citizens, how come they don't develop them on their own or subsidize their citizens drug expenses from government coffers; instead of painting the drug companies as the bad guys deserving to be robbed?   

I think those in need should receive help.  But their governments are not heroes.  While the governments are being subsidized by productive foreign Inventors, the governments should at least say "Thanks".

November 21, 2016/p>

Moral Compasses and CRISPR Human Gene Manipulation

It could well be that people in certain countries have never read the science fiction dystopia literature I grew up with.  What could possibly go wrong with government control - of the gene pool?

The West learned lessons from the eugenics movement before and during World War II.  The Western culture, for all its faults, has learned some lessons and retains a moral Compass somewhat independent of government. 

On the other hand, as scientists we know that the strong survive, and science marches forward, and the frog does not hop out of a slowly heated pot. 

China invented the Compass.  China did not discover CRISPR technology, hopefully they will not be the first to abuse it in light of Western standards. 

November 20, 2016

Easy Custom Medicine - Multiplex Cancer Drug Screening 

This is a complex procedure with plenty of variables that could make it fail.  Ironically, this procedure probably has to be custom configured for each custom medicine determination.  Still, I like the aspect that you could screen several anti-cancer drugs at once in a few days.  See full journal article at: http://www.nature.com/articles/ncomms13325

This process in not simple (or free).  Prepare a "nanoparticle" (liposome) containing the anticancer drug and a barcode (DNA oligomer).  A variety of these nanoparticles are prepared with different drugs and barcodes.  Administer the nanoparticles IV and wait for the nanoparticles to fuse with cancer cells and release their load.  Wait for a therapeutic effect.  Take a biopsy of the tumor and analyze the cells for the presence of the bar codes. Generate a database comparing the viability of the cancer cells with the presence of the drug associated with each bar code.  The anti-cancer drug with the highest correlation to dead/dying cancer cells is the choice drug for the patient.

Selective liposome delivery depends on access through the relatively leaky capillary endothelium of many tumors.  Of course, the liposomes could be targeted to particular cancer cell types, e.g., with affinity molecules on the membranes.

It was not clear to me how the efficacy testing dose can be different from the therapeutic dose, since the assay is based on a comparison of tumor cell death to the presence of the barcoded DNA (associated with a drug).  By the time you are getting an assay signal, aren't you already treating the patient?  Perhaps they could do the assay in mice implanted with the patient's tumor cells.  Or, maybe the assay could look for sick (less viable but not dead) cells straight from the patient.  I suppose there are cell sorter techniques that could identify the tumor cells in suspension and separate them according to some viability characteristic.  In my mind, I see a pathologist reviewing tumor biopsy slides and rating viability by morphological differences (sick cells look sick) in identified  cancer cells. 

The assay can identify a single DNA bar code in a cell.  Maybe the dosage delivered could be determined by quantitating the number of barcodes in the cell.  The most sensitive method would probably be some form of in-situ PCR or quantitative PCR (isqPCR?).   

It seems the system could be validated for certain common forms of cancer.

November 19, 2016

The Horror!  A Circular Traffic Pattern.

There are a lot of benefits to cutting the corners from the rectangular traffic pattern. 

Students would become proficient immediately because that is already what they are doing.

One problem may be that there is not that last look along the approach before turning final because the wing is tipped up.  Commercial and military probably do not have this problem because they are typically in a radar environment.

November 18, 2016

Time's 25 Greatest Inventions of 2016

My favorite was the artificial pancreas.  Least favorite was the 360 wheeled car (not actually an invention because they have not reduced it to practice, and was probably in Popular Mechanics 50 years ago).

Haven't these guys heard of CRISPR? 

November 17, 2016

 Preamble and Claim Scope - and the Canon of Term Differentiation

In a coaxial cable, the "continuity member" 70 (continuation of shield through connector) was positioned in the claim to reside "around" the connector body.  The Examiner's broadest "reasonable" interpretation was that "around" can be near, about, or anything Webster's Dictionary suggests, ignoring the context of the specification and drawings.  All this, actually, to make the claim fit the closest combined prior art combination for an obviousness rejection (and so the Examiner can get his points without the stress of allowing the case).  Am I cynical?  

I have recently had a similar case, and will certainly cite this ruling.  I had a claim feature of a chamber "around" another chamber.  The Examiner came up with a chamber near a chamber.  Sheesh. 

Anyway, the Court is not worried about getting points for their quarterly quota and is more focused on the "reasonable" requirement, and fairness to the inventor.  The Court stated that the "fact that 'around' has multiple dictionary meanings does not mean that all of these meanings are reasonable interpretations in light of this specification" and Figures.  This is actually old news, but routinely ignored by Examiners, at their convenience. 

The more instructive aspect of the case was the confirmation that the preamble is not only not limiting to the claim scope (unless required to bring life to the claim), but essentially immaterial to interpretation of key claim limitations, at least regarding some canon of term differentiation. 

November 16, 2016

More PTO Guidelines on Patent Eligibility  - Be Unconventional

New USPTO Guidelines on patent eligibility reiterate and add detail from Court holdings that are stressing that the Examiner has to use facts, and can not merely state that each of the claim limitations, e.g., around an abstract idea are conventional. 

The Examiner must consider whether the combination of elements is unconventional and adds "something more" to the ineligible element.  A strong argument for patent eligibility is still found in the inventiveness (unconventionality [non-obviousness?]) of claim limitation combinations.

Further, when the claim limitations provide specific functional interactions (not just claiming results), the claim is more likely to be inventive and found not to preempt the abstract idea. 

The software patent is not dead, but the BFD (block flow diagram) must be unconventional. 

See new Guidelines, below.

 https://www.uspto.gov/sites/default/files/documents/McRo-Bascom-Memo.pdf

November 7, 2016

Pros/Cons, and Oddities of My First Post-Prosecution Pilot Program (P3) Conference

I have recently had my first P3 (Post-Prosecution Pilot Program) conference with the USPTO discussing final rejection of a patent application.  The P3 was supposed to be essentially a Pre-Appeal Review Conference (PARC) that allows the Applicant to participate. 

See P3 at: https://www.uspto.gov/patent/initiatives/post-prosecution-pilot

See PARC: https://www.uspto.gov/web/offices/com/sol/og/2005/week28/patbref.htm

I have Requested a lot of PARCs, with some success.  However, there are big problems with the PARC procedure.  For example, the Applicant does not get contribute, or even listen in.  Worst of all, the issued PARC "Decision" only says whether the rejection(s) are retained or dismissed.  The PARC Committee does not have to present any facts with the Decision.  If you argued three issues, the Committee may have agreed with Applicant on 2 issues and disagreed on one - the Decision will only say that the case will continue on to Appeal because "at least one issue remains for appeal".  They won't even say what issue that was.  Note that I have had about 40% of my PARC Decisions go in my favor, requiring the Examiner to withdraw rejections; not that this led to an immediate Allowance. 

So, with the PARC, I include a request that any Decision also include a summary of the discussion and any facts key to the decision.  I also only use PARC to focus on only ONE key issue, so I could at least know what the "at least one remaining issue" was.  Well, these strategies have not always worked.  About 1 in 5 times, the Examiner is nice enough to include a statement identifying the remaining issue and the key continued rejection logic.  A few other times, I got on the phone with the Examiner after the PARC Decision and could get some more information.  The big problem with Post Final Review Conferences is the lack of information about the basis of the issued Decision. 

 --------------

HowHow did my first P3 go?

A problem with Request for Pre-Appeal Review seems to be that the Decision can be almost devoid of information, unless the Committee is persuaded on ALL issues. 

With an adverse PreAppeal Review Committee (PARC) Decision, you are not left with any new information, e.g., to strengthen your arguments in an Appeal Brief. The P3 conference has the Applicant teleconference in the conference (same as PARC, with the Examiner, Supervisor, and a neutral Examiner from another art group[?]). The Applicant is supposed to have 20 minutes to state their case to the committee.

I have yet to receive my P3 (Post-Prosecution Pilot Program) Decision from a recent conference. I am not going to get into the details of the case, but this is about how it went.

I started to give my well organized presentation, and was immediately interrupted by a very smart Primary Examiner who raised an issue, not previously of record, concerning claim support. I was a little blind-sided and distracted by this unexpected diversion.

I got back to my key argument (laboriously researched and outlined). The Primary stopped me about 15 seconds into my discussion and the rejection was in error, and I was right. Yay.

I went on to my less objectively clear back-up argument concerning an obviousness rejection issue. I could tell Committee was not convinced, yet they couldn't state clear facts why my literal correctness was unconvincing (they apparently had a gut feeling the prior art taught more than it said).

Next, I got the bad news. They told me, even though I had sent in a final Response before the P3, there would be no Advisory Action issued by the Examiner in reply. Further, they said, they do not have to give a fact-based rationale for any Decision coming out of the P3. I respectfully requested that they present facts with the Decision, but they would not commit. Where does this leave me?

I immediately filed an Interview Summary memorializing the conversation (not that any statements written or spoken by the PTO are binding).  If the P3 Decision finds at least one issue remaining for Appeal, will they tell me what issue it is?  Will I never get a written reply to my filed final Response?  Will I only later know the Examiner's official position from the Examiner's Answer AFTER I file an Appeal Brief?   This is a major problem with P3, if what the P3 committee said is true.  I still need to talk to a PTO Quality Specialist to see if it is really true there is no Advisory Action or fact-based Decision after a P3 conference. 

Depending on the case, there may be little benefit of a P3 (getting to discuss the case with the Committee) if you have to give up the right to receive written Patent Office positions, e.g., on the record  in reply to Applicant's final Response.   

Must I draft the Appeal Brief based on essentially the same information of record that formed the basis of the already filed Response?  I think this P3 is not very useful to Applicants (and not efficient for anyone) if the Examiner does not have to issue an Advisory Action based on the final Response and P3 discussion. 

This is a pilot program.  Hopefully, the USPTO will ensure the results put BOTH the Applicant's and Office's positions on the record after a P3 conference. 

I would appreciate comments of others regarding their P3 experience.

November 2, 2016

Boeing's Most Recent Fighter Concept

Boeing is signaling to the Air Force what direction a 6th generation fighter jet should take. 

The common thread in recent military designs seems to be tailless.  Less drag and radar reflection.   

It is a little surprising they have not abandoned a pilot in control.  Pilots will definitely be gone from penetration fighters at least by the 6.5th generation. 

November 1, 2016

Genetic Tracking of AIDS Origin and Spread Timeline

This research traces AIDS back along to its origins.  Almost 100 years ago in Africa, 50 years ago in Caribbean.  Jump to New York city about 1970; then on to Europe, Australia, and Asia from there! 

Arriving in San Francisco about 1976, where it was noticed and brought to light in the early 80's.  I was working as a Medical Technologist at Stanford Medical Center then, and boy did it raise a ruckus.  Lots of training and fear. 

Much of the time tracking of HIV was based on genetic sequencing of old clinical samples having known sampling dates.  Tracking of particular mutant sequences and mutant offshoot branches helped untangle the transmission routes and timeline.

October Entries:

October 31, 2016

The Standard(s) for Rejection of Design Patents

Design patents cover the ornamental non-functional aspect of a object.  Strangely, the rules for evaluation of inventiveness are similar or identical to the rules used to evaluate inventiveness of a functional device in a utility patent. 

For example, both designs and devices are subject to novelty (35 section 102) and obviousness (35 section 103) rejections.  Case law holdings from one arena are often applied in the other. 

Novelty usually requires that there is not a single prior art reference that is exactly the same as the claimed subject matter (in design patents, the solid line aspects of the figures).  Some design patent case law allows novelty rejections where there is a less than perfect "substantially the same" appearance. 

In utility patents (e.g., claiming functional methods, compositions, or devices), obviousness rejections usually cite a close primary reference and say it would be obvious to modify according to the teachings of a secondary reference to arrive at the claimed subject matter.  This was brought up in the article, with regard to design patents, but I did not notice an example.

Novelty rejections in utility patent applications are usually pretty objective.  Either the single prior art reference describes (actually or inherently) the claim or it does not. 

Obviousness in utility patent applications is a little more subjective, but subject to certain rules, such as a  combination of references should not require elements from a secondary reference to function differently in the combination than in the reference itself.  Of course, since designs are the non-functional aspect, this analysis can not take place. 

I have a gut feeling that many design patent rejections are based on the prior art being close and the Examiner having a gut feeling the design is to close to the prior art.  The Examiner knows obviousness when he/she sees it. 

October 28, 2016

Bayer Buying Monsanto to Control GM

This article is supposed to be about Monsanto, but is actually a good overview of the history of GMO crops in the world.

Back in the 1930s, there was good public transportation in the San Francisco Bay area.  That included commuter trains across the Bay Bridge.  Then, an odd thing happened.  General motors (GM) bought the train systems, and systematically tore out the tracks.  The strategy was to sell more cars.  It took decades before a train crossed between Oakland and San Francisco again (the Bay Area Rapid Transit BART tunnel under the bay). 

I was amused that this time Bayer is buying GM (genetically modified).  Do you suppose they might tear up the Monsanto tracks of GMO crops that need less insecticide; so Bayer can sell more?  Just a thought. 

October 27, 2016

New Species in a Second - Xenopus is Double Chromosome Cross of Two Species

Apparently, many Xenopus frogs are tetraploid.  This has been known for some time.  This article discusses recent sequencing work that strongly indicates the tetraploidy resulted from a combination of all the chromosomes from two different species of frogs ten million years ago.  

The sequencing finds that the two sets of chromosomes have different authors (I assume authors are identified by preferred triplet codon usage and preferred peptide domains in identified proteins).  Interestingly, the chromosomes from one frog species seem to be more well preserved, while those of the other frog seem to be more modified.  Do you suppose the egg chromosomes were better suited and were preserved over the interloper sperm chromosomes?

There is one species of frog in the Xenopus genus that does not have double chromosomes.  I wonder if it should be considered the same species.

Has anyone offered a theory as to why double chromosomes made the frogs bigger?  Need larger cells for all that chromatin, double expression of growth hormone, more ideas ...

It seems doubling of chromosomes and even genomes has been fairly common in early and primitive eukaryotes.  Polyploidy is pretty common in plants, with 4 or more copies of a particular chromosome.  And, I assume that we have 23 pairs because the very first chromosome was doubled, at some point, and again ... 

Still, my mind keeps going back to an image of 200 or more chromosomes trying to line up at the equator for a cell division; or, wondering what the selective advantages and disadvantages of chromosome doubling would be; and, that people with gout should avoid eating xenopus frogs. 

October 26, 2016

Fine Print in CRISPR Licensing Contracts - No Gene Drives

In the early restriction endonuclease days, we established laboratory "P" level containment standards, depending on the threat of a microbial escape. 

Now, we have CRISPR and similar protections should be made preventing the escape of multicellular organisms, depending on the associated risk (near as we can logically ascertain) to the organism's gene pool.  I suspect a yellow fruit fly would not be a great hazard.   

As further protection, research organisms might have kill switches built into their engineered genes.   

There are those who would like to modify mosquitoes with a gene drive rendering them ineligible hosts for Zika.  O, even to wipe out the entire species of Zika carrying mosquitoes (much to the despair of certain bats and swallows).

Here, an MIT inventor suggests that licenses to CRISPR technology (arguably the rightful property of UC Berkeley) require responsible CRISPR users to not experiment in "gene drives".  A gene drive can force insertion of a gene into consecutive generations of a species by cutting chromosomes that don't have the gene drive yet inserted and copying the drive sequence onto the chromosome while the cut is repaired.  This dominant trait is passed on and further modifies second parent chromosomes to spread through the gene pool over many generations.

The restrictions and experimental plan publication terms could be enforced by contract; where people have respect for IP and contracts.

October 25, 2016

Jet has Successful May Day Fuel Exhaustion Blind Landing After 6 Go Arounds

I imagine the jet took off with less than full fuel tanks, as is the norm to save money, even with the bad weather. 

It seems they did go to an alternate airport (hard to pronounce, but possibly the alternate reviewed for weather before filing a flight plan?). 

They might not have broken any regulations, but in hindsight should have headed out earlier to an airport with a known high cloud ceiling.

The only suggestion in the article is that the carrier (Jet Airways in India) should have had a more strict policy on the number of acceptable go arounds. 

Saved by the technology of the venerable 737. 

Not sure what particular facts were the basis for the demotion of the Pilot in Command. 

October 24, 2016

Public Institutions Selling Out to the Patent Trolls

Kind of an odd article.  The interesting part might be what is left unsaid.

University offices of technology transfer do their best to license out their technologies.  If they can't find a licensee, they are not in the business of marketing the product, or even paying maintenance fees.  They do need to justify their existence by generating a net positive cash flow to subsidize the costs of the institution and research. 

So, off go some patents to the evil patent trolls.  However, let it be known that those accused of infringement could have licensed the technology from the University, or ... the Troll. 

October 14, 2016

Success of GMO Crops May Change Their Unfair Reputation

GMO crops have been unfairly maligned as somehow dangerous, though there are few facts backing this up.  

The bigger problem in the long run is that there are Not a lot of facts showing everyday citizens the benefits of GMO.  Every day billions of people eat GMO food without knowing it or thinking about it.  An inserted trait in the corn or soy beans may add a 2% convenience to the farmer, and help reduce the price by 1%, but the end users never notices this. Even the redder tomato, non-browning apple, and golden rice have done poorly in the market, because they were not preferred over alternatives in the market. 

GMOs have to present a better product at a lower price in order to get a good reputation. 

When you turn a traditional food like rice "golden" yellow (vitamin A), you can't expect a traditional society to accept it.  Just because a tomato is redder, or stores longer, does not mean people will buy it, unless it tastes better.  And, if a farmer in Africa can have a better harvest than his neighbor, of a crop everyone wants, then the shift to GMOs will pick up. 

Too bad people tend to listen more to non-scientist journalists and politicians than to objective scientists.   Dramatic GMO improvements to food products can gradually move us away from the Frankenfood hysteria.  Sorry to say, the big danger is if even a minor problem arises (allergy antigen hurts someone, or a gene changes spread harmfully to a wild parent in nature) all progress could be lost. 

Brief - GMO Authorizations of GMO Food Sale

The European Union has a Commission that authorized GMO food sales of food grains with very specific "mutations".  These should be sellable throughout the EU, with proper labeling. 

But, no cultivation.  Wouldn't want mutations to go viral. 

October 12, 2016

Rebuilding a 45 Year Old Sport Car Engine

This will be the story of rebuilding an engine for a '72 Datsun 240Z sport car.  As I make progress, I will file updates.  This is less of a hobby for me than a style of life.  I have done all my auto mechanics since my mid-teens.  I hope some of my followers will find it interesting. 

When I bought my Orange Z ('72 240Z with 280Z block) from a Berkeley professor 20 years ago, it was running horrible and had a lot of issues (see: http://www.biopatent.com/l28.htm ).  It is a long story how I got the engine to run with smoothness and power (different cam timing, computer adjustable distributor timing curve; usual headers, and such).  But, now there are 200,000 miles on the motor (about 400k on car) and I have noticed the number 2 cylinder has slightly lower compression and misses some when the engine is cold.  Time to think about getting a new engine (3rd) ready for the 45 year old car. 

The basis of my new engine will be a 1978 280Z engine I bought from a local guy on Craig's List for $250.  On initial inspection, I see the coolant channels are pretty rusty and there is a light rust on the cam.  On splitting the engine, head (valve train) from block (crank case), I see the timing chain, gears and tensioner system have all been recently replaced. 

I can see why this engine had to be removed from the parent car. There are wear marks on the exhaust valve cam lobes run all the way around the whole cam, not just on the lobe.  The exhaust valve on the number 1 cylinder is all white (over heated and oxidized).  The evidence suggests there was no clearance between the cam and valve even when the valve was supposed to be closed.  This happens when the exhaust valves slowly set deeper and deeper into their valve seats with use, eliminating the valve clearance.  With no clearance between the valve and cam, the valve does not seat fully and can not cool down when closed.  Eventually, the valve burns up for lack of cooling.  For lack of a simple valve clearance adjustment (20 minute task) the exhaust valve in the number 1 cylinder burned and the cylinder lost compression.  Valve clearance must be adjusted every couple of years or so in a 240Z. 

 

The next step in rebuilding this engine will be to remove the pistons and crank shaft for inspection.  I have done this several times with other Zs over the years.  I am always amazed that nothing (Nothing) is ever out of specification in 240Z/280Z blocks, even after 150k miles.  For example, there is not ridge in the cylinders at the top of the piston travel, and no excessive clearances in the bearings.  There are always problems (cracks, worn valve guides) with the aluminum engine heads, but not the blocks. 

 

Next steps:

 - Remove crank shaft and pistons.  Use micrometers to check for wear in the bearings and cylinders.

- Decide what parts need to be repaired or replaced.  Order required parts and rebuild kit (bearings, rings, gaskets, seals).

- Reassemble block with new parts.

- I bought a brand new E88 (240Z) head about 15 years ago, and I will use this head on this project.  Assemble valves and cam shaft into the new head.

- Bolt head onto block, making sure the timing is correct between the crank shaft and cam shaft. 

- Mount intake manifold.  I have a rebuilt pair of stock side draft SU carburetors but will hold off on installation until the engine is in the car (making it much easier to bolt the header exhaust pipes onto the engine).    

- Bolt on final external features, such as water pump, fly wheel, and clutch. 

This may take a while, but no hurry.  My Z still runs fine with the old motor. 

October 11, 2016

More On the Monsanto CRISPR Licensing (and Patent Interference v. UCB) 

This is a more comprehensive article on the licensing of CRISPR technology to Monsanto from the Broad Institute (MIT patent licensing group).  Article, below.

Also follow the more interesting back story concerning who may actually own the CRISPR technology.

https://www.technologyreview.com/s/602195/in-crispr-fight-co-inventor-says-broad-institute-misled-patent-office/

I believe that UC Berkeley may have conceived or practiced CRISPR first, and actually filed a patent application first. Then, MIT strategically filed an application and paid for accelerated patent prosecution so that their patent issued even before there was a first Office Action in the UCB patent application (it often takes more than 2 years for a first Office action without acceleration of the case).  

The invention and application filings happened before the America Invents Act, which changed U.S. patent rights generally from "first to invent" to "first to file".  Under the first to invent system, a later filer can file an "Interference" and show notebooks with an earlier date to obtain seniority over other patent applicants or patent owners. 

So, MIT has filed an Interference attempting to show their several CRISPR patents should have seniority over the UCB CRISPR patent application (13/842,859, with the earlier filing date, still under prosecution and not a granted patent)

See UCB application at:

https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US20140068797.pdf

This will become a battle of the notebooks to see who was actually first to invent.    

October 10, 2016

Can a Turkey Trot at 65 kph from 500 Feet? 

If the area is not "congested", airplanes are supposed to be at least 500 feet above ground level (agl) and 500 feet from people and structures (and at an altitude allowing a safe landing).  In congested areas, the plane has to be at least 1000 feet agl above any structure within a 2000 feet radius.  

Sorry, but that photo shows the turkey being "released" at Less Than 500 feet agl, probably flying somewhere near stall speed, not far from people.  The FAA has been somewhat inconsistent in what they call "congested", e.g., maybe depending on safety or complaint issues.  Here in the Bay Area, it seems common for GA pilots to fly closer than 1000 feet from the Golden Gate Bridge for tourist tours.  In any case , a nearby Turkey Festival may be considered congestion, requiring the "releases from at least 1000 feet.  How far might the turkey fly (drop?) from 1000 feet?

Animal stress issues aside, the Turkey Trot Festival might look into their compliance with regulations.  ... before they have to talk turkey with the FAA. 

October 9, 2016

TM - Color Combination Marks Identifying Product Source

As I recall there have been valid several single color trade dress marks, e.g., yellow for Kodak. 

Now, here with multiple colors, there seems to be a requirement for a specific pattern in the combination of colors (making it essentially logo design); unless you can obtain ($) an adequate survey showing the consuming public uniquely associates the color combination (regardless of pattern) with a specific source of the products (acquired distinctiveness).   

Such marks will remain uncommon because of the huge expense in sales and advertising with the color combination, then the expense of the valid survey required in Court should you ever have to enforce the mark.   

Still, I think I will start a boxing club and try to obtain a trademark on black and blue; or maybe a newspaper that is black and white and read all over. 

October 6, 2016

Non-Engineered Plant Cultivars - A Life's Work

You all know it.  Cross breading, selection, characterization, expansion ...  Slower than genetic engineering, but less monstrous. 

Good thing new deciduous cultivars of most plants can be faithfully reproduced from cuttings (scion wood).  Still, waiting for a tree to bear fruit is like watching grass grow.  Um ... I mean like watching a mountain crumble. 

And, there is a special place at the Patent Office especially for plant patents, protecting plants grown from cuttings.  And, apparently trademarks are especially important in the crowded apple marketplace.

October 3, 2016

Biotech Investments on an Upturn? 

Biotech investments and options (Chiron Corp - HepC, PCR) got me through law school.  After that, biotech investments seemed to languish.  Then, Supreme Court rulings put into question the patent eligibility of certain drugs based on natural sequences, or diagnostics that detect them.  It all got worse when the Media started attacking biotech for Frankenfood and over priced pharmaceuticals.  A lot of bad news. 

The article suggests the pendulum may be swinging.  Although big pharma does not seem able to make their own drug pipeline, the value of small companies with valuable patents is rising.  The Federal Circuit Court has eased up somewhat on patent eligibility rejections of drugs and diagnostics.   

It would be great if some company got super rich actually developing a drug that eliminated a disease - Alzheimer's, breast cancer, MERSA?

September Entries:

September 30, 2016

I'm Not a Number - Just a DNA Sequence in Police Databases

I was remaking to my wife today that the opposite of Orwell's 1984 seems to be happening.  Instead of the government having a camera in every house watching the citizens, the citizens all have cameras watching the government. 

And we have avoided national identification cards, and most people do not have RFID chips under their skin.

The problem is, there is a new form of surveillance and identification that is progressing rapidly.  The police forces have the ability to test all locations and see if we (or sloughings of our bodies - "abandoned DNA") have been there.  They don't even have to get our permission (even if we are minors).  Just as we have no expectation of privacy in a public place, apparently we have no right to our DNA that may be in a public place.  And once they have your DNA, you DO have the equivalent of identity card or identification chip under your skin.  Between all the public cameras, and DNA sampling at locations where you have been photographed, you don't have to volunteer your DNA for you to be identified in a database. 

Why bother to analyze a fingerprint pattern when there is enough DNA in the fingerprint to identify you, and even make a good guess at what your body and face look like?

So, if your DNA is at the site of a crime, you are suspect.  And, if you are a victim, you should give a DNA "elimination" sample so you can be excluded as the perpetrator (and placed in a database).  And, we should all get into the databases anyway because if we did nothing wrong, what do we have to hide?

September 29, 2016

You Can't Sue for Patent Inventorship Change Merely to Inflate Your Resume. 

It is essential to get the inventor list of a patent correct.  However, it is not always clear who the Inventors are of a claimed invention until the claims are finally allowed.  If the listed inventors in the patent application are not correct, a Correction of Inventorship should be filed, preferably between the allowance date and grant date.

If inventorship is intentionally misstated, this can be considered inequity on the Patent Office and the entire patent can be invalidated, for all Inventors and Assignees.   

In many cases (researchers for industry or academia), the inventors have signed Assignment documents passing intellectual property rights to their employer. 

Apparently, in this case an alleged inventor of a formulation at Pepsico believed he was an omitted inventor, and (darn it!) he wanted to be able to put it on his resume.  Sue as he might, to the second highest Court in the land, he did not present a case showing "standing" in the case.  That is, you can not sue with no damages or controversy.  Since the "inventor" had relinquished ownership of the patent, he was not damaged, e.g., in loss of property or licensing rights, in not being a listed inventor.   Hee also could not show material damage to his career, (e.g., e was turned down for a job for lack of a patent).  Because Courts do not like to litigate issues of no value, they deemed the "inventor" had a lack of standing to sue.    

See the Federal Circuit Court decision at:

http://law.justia.com/cases/federal/appellate-courts/cafc/16-1668/16-1668-2016-08-05.html

September 28, 2016

More On GMO/CRISPR (Read the Food Labeling Law)

Sorry to be the GMO/CRISPR guy, but this recent article seems to provide more information than other articles I have seen on the subject.

The new bioengineered food labeling law passed in July defines bioengineered as product of in vitro recombination producing a food not capable of being obtained by conventional breeding.  See the law at:

https://www.congress.gov/bill/114th-congress/senate-bill/764/text

The author of the article seems to think CRISPR can only be used for deletions of genes, so CRISPR products must not be considered bioengineered because deletions or inactivations of genes can be obtained by natural breeding.  Let him and the politicians think that.   

Would it be hard to detect CRISPR deletions?  Yes, according to the author.  However, I expect it would be routine to detect either additions or deletions, if the modification (e.g., point of ligation) were a matter of record. 

September 26, 2016

CRISPR Modified Organisms Are Not GMO?

There was the case where a plant having a gene Removed using CRISPR was not considered to be a genetically modified organism, in the U.S.   That is because there was not a Foreign gene introduced (not "Frankenfood").  I think it is arguable that such modifications are literally genetic modifications.  But may not be considered "recombinant".

CRISPR has the benefit that the modifications can be intelligent and predictable.  For example, random insertions that might cause a truncation or unintentional changes to expression of a gene can be avoided.  I guess this control makes the modified organism less yucky. 

To make things a little more politically correct, the MIT license to Monsanto for use of the CRISPR technology does not allow for production of infertile seeds, or certain tobacco modifications. 

But - Does MIT own the CRISPR technology?  I believe CRISPR is also claimed in a patent application by the University of California.  I wonder what clauses are in the MIT licensing agreement assigning responsibility to defend against possible future infringement claims?

September 21, 2016

Receipt of Contract Manufactured Drugs Did Not Constitute a "Sale" Barring Patent Validity  

It is reiterated that the "on sale" rule disqualifying patents after 12 months in the U.S. (and immediate disqualification in many other countries, subject to their rules) does not apply to contracts for manufacturing services.  That is, it was contract manufacturing services sold, and the receipt of the drug product by the patent holder was not a sale.

A "sale" is identified according to the U.S. Uniform Commercial Code UCC 2-106  -  https://www.law.cornell.edu/ucc/2/2-106 

It may be argued that Medco already owned the drugs manufactured for them under the contract, so the title to the goods was not transferred.

I assume the defendant in the infringement case knew their argument was probably not good, but raised it anyway, as defendants do.  Best practice would be to make it clear in the manufacturing contract that it is a contract for services and not sale of product.  And ... better yet, get a patent filed Before you make contracts involving your inventive product or process.

September 20, 2016

A New Cause of Ageing

Wouldn't it be nice if telomere sequences could be inserted into the transposons and trained with CRISPR to migrate to chromosome ends.  Just when the transposons were getting fired up, the cells would get reinvigorated telomeres, and our wrinkled skin would go away!

If only Barbara McClintock had lived to see this.

September 19, 2016

European Patents "Higher Quality" Than U.S. - Can It Be Motivations of Examiners? 

I believe that patents I get granted in Europe are of higher quality.  This is probably because the European Examiners are not subject to perverse motivations to do other than use facts and logic ensure the inventiveness of claimed subject matter.

It seems counter intuitive, but American Examiners seem to ultimately grant lower quality patents even though they reject all claims in every first Office Action.  I believe this is because the Examiner's put more effort into accumulating their mandatory "counts" for administrative milestones in the Patent Office count system than for providing the most well considered outcome.  For example, why would an Examiner identify allowable subject matter on first Office Action, when the Examiner can get more counts for allowing a case after a first Office Action or causing abandonment of the case?  Not that Examiners are unethical or lazy, but more likely overworked by a count quota system. 

Then, why is the USPTO accused of issuing patents with too broad of claims?   Is it possible that the lack of quality cooperation of Examiners in the U.S. makes their cases look so bad that they later allow poorly prosecuted cases, just to sweep them under the rug?  Maybe the Examiners reject in the first Office Action to get the counts, then force the case into the final phase where they can get a couple more easy counts by converting and making a bad allowance?   

The European Examiner's Reports are typically straight to the point and focus on real fact-based issues.  In turn, they can be persuaded to allow by a logical fact-based Response (on not, by subjective hand waving).  It should not be surprising that the well reasoned and cooperative European prosecution results in higher quality patents.   

Now, if we could just get the European Patent Office to allow claim amendments based on what one of skill would know from reading the original specification. 

September 16, 2016

Optical Defibrillator At the Speed of Light, Sort Of

The optical defibrillation "assumed that a light sensitive protein was genetically introduced into the cardiac tissues".  In initial studies in rats, a "special virus" was introduced onto heart rat ventricular myocardium to make it express the channelrhodopsin-2 transgene.  The expressed gene is an ion channel and exposure to light resulted in depolarization of heart muscle cells.

I guess the problem addressed is the potential to damage heart tissue with an electric defibrillator.  But ... how risky is the intrusion of a virus and illumination hardware into the chest cavity?

There's got to be a better way.  Imagine you are in the airport and someone is having a heart attack.  Do you want to infect his heart with a virus, then shine a light on his open heart? 

September 12, 2016

Beginning to Identify Long Noncoding RNA (lncRNA) Function

The long noncoding RNA (lncRNA) known as Braveheart is associated with development of heart muscle.  Odd that it does not seem to be conserved across other mammals.  

Well, this is a start of a huge amount of work identifying how the dark matter of non-coding sequences form functional complexes with what peptides and/or nucleic acids.  Not to mention that this current study has only linked 2% of this one lncRNA to a function. 

I guess we should not think of the lncRNAs as the dark matter of the gene, since they make up about 80% of transcription and have always been in our cDNA libraries.  This is more evidence that RNA is probably the basic foundation of early life, with DNA coming in second.

I can't wait to hear the surprises that will come out of this research. 

September 11, 2016

New FAA Rule on Slow Flight Requirements

One of my favorite maneuvers is slow flight.  According to the old rule, my instructors had me fly the plane so that it was just on the edge of actual stall (way past the point the stall horn came on), then have me maneuver the plane to any given heading in this condition.  Really radical.  The whole plane shaking and dancing around loss of control.  One time, I had the Cessna 172 holding altitude at 28 knots.  My instructor could not believe it and had to take a photo of the air speed indicator.

Apparently, the new rule would have the pilot only take the aircraft to its 1G stall speed for the maneuvers.  I believe this is about 40 knots in a 172.  That is a big step back.  I could be eating a sandwich while flying a 172 at 40 knots.  Now all the young pilots are going to be soft. 

September 10, 2016

FDA Device Guidance Seems to Take Practical Approaches

I fly airplanes and have been happy recently about the practical approach Federal Aviation Administration (FAA) has taken in allowing modifications and improvements in older aircraft.  For example, they allow modern GPS installations, use of iPads for approach plates, and addition of angle of attack displays in "legacy" aircraft, such as 40 year old Cessnas, without full blown certifications for each plane and model.  Practical ways to increase safety. 

The FDA seems to be following a similar pattern in the various published guidelines (see overview in article), e.g., for the introduction of new technologies into the old mature realm of medical devices. 

September 9, 2016

Mean (Not Nice) Finding of Means Plus Function By Courts

This case (see the Fed Circuit case at: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1732.Opinion.7-26-2016.1.PDF) seems to use bad facts to generate a bad holding.  In the context of the claims and the specification, one of skill in the art (and even one of ordinary language usage) would have known what reasonably would be considered a "symbol generator".  For example, a source of symbols to identify the location of various cell phones on the map.  And, indeed the figures showed examples of individual positions on a map, distinguished by geometric symbols. 

I believe the general rule is approximately that claim terms are interpreted according to what one of skill would understand in light of the specification and art (geez, I assume also at least "common sense").  In this case, it appears that the inventor did not intend to have the term construed as a means plus function under 112, paragraph 6.  But, by unreasonably characterizing it as such, it became a lot harder to argue against indefiniteness, because (the Patent Office knew) there was no extended discussion of various symbol generator means.  With no support for means, the Office did not have to make arguments about reasonably interpretation of the phrase. 

The Fed. Circuit reviewed the District Court holding based on the "clear error" standard, so even though the result was unreasonable, it did not meet the clear error high hurdle.  Remember that one does not have to include the meaning of well known words (e.g., generator and symbol) in the specification.  If the District Court had not erroneously deemed the claim a means plus function claim (focusing in a term not even at the point of novelty) the rejection would have had to argue that no one can figure out what is a symbol or a generator of a symbol. 

Ironically no one argued that symbol generators were not enabled.  Anyone could have devised a proper one for any embodiment,  including generaltion of symbols, in light of the specification. 

What is the lesson?  Make sure every important phrase in your claims is defined in the specification.  Provide definitions, if you are going to be your own lexicographer. 

September 8, 2016

To Withdraw From Opioids (or Life), Please Step Into My Pressurized Oxygen Chamber

Two words: bomb calorimeter.

What a crazy way to get a body mass index (BMI).  Please ask the person in the pressurized 100% oxygen atmosphere not to brush their hair, there may be a spark.

September 7, 2016

Interesting Catheter System with Diverse Capabilities for Visceral Vasculature Manipulations

I am not always sour grapes.  RenovoRx's RenovoCath RC120 catheter seems to be a highly versatile and modular system capable of a variety of interesting procedures.  These capabilities seem well suited to enhancing blood flow and drug delivery in peritoneal organs. 

Forget about pharmacokinetics, with the optional fluid output ports and balloon locations, the system seems capable of depositing therapeutics at a target location of interest, and holding it there for brief time intervals without them being washed away into general distribution.  Further, it appears that the system can perform surgical perforations, angioplasty, (and stint placement?).

See patent at:

https://www.google.com/patents/US8821476?dq=inassignee:RenovoRx&hl=en&sa=X&ved=0ahUKEwjnu_a5ufPOAhUI5CYKHc1yADkQ6AEIHjAA

September 6, 2016

The Hubris and Folly of 3D Liver Designers

It is not hard to imagine how a 3D printer could be used to mimic the order of different cell types in a tissue.  The cells would be laid down in layers and constricted in movement by some kind of matrix, and get a source of oxygen shortly thereafter, as the thickness grows.  One article suggests pre-forming vasculature paths between the cells with dissolvable sugars.

Then, all these cells, in many 2D layers, need to start interacting and connecting to each other.  The article seems to suggest this would happen naturally - "good chance it will continue to grow into a fully functioning organ once implanted in the body".

What caught my attention was the article's suggestion that we would soon be printing "fully functional" livers.  I'm not sure the author understands the complexity and diversity of the king of organs - the liver.  Structurally, the liver is complex, with a regular blood supply (with reticuloendothelial characteristics), a portal blood flow receiving blood straight from the intestines, a lymph system, and bile canals.  This is maybe the most complex array of channels in any organ of the body.  Fully functional structure is not going to happen soon.  I assume the author really meant that hepatocytes surrounded with some fibroblasts and epithelial cells may channel some blood to be detoxified in a liveroid or liverette.

The liver is the organ most famous for regrowing itself.  Seems it might be simpler to take a patient's bad liver tissue (hopefully not too badly scared) and repopulate that structure with healthy hepatocytes. 

I think we will see fully functional ears and breasts long before we see fully functional 3D livers. 

September 3, 2016

Myriad Loss of BRCA Diagnostic Method Patent Was Not Loss of BRCA Gene Database

Even though Myriad lost the patent to the BRCA gene diagnostics (https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf), they retain a trade secret in their BRCA gene sequence database and their proprietary correlations.  The claims to a diagnostic assay for BRCA genes were held in Court to be unpatentable natural phenomenon and correlations.  However, Myriad still has a trade secret database of, e.g., single polynucleotide polymorphisms (SNPs) and mutations correlated to a various subtypes of cancer.  With this data, they can statistically provide even more confident information on breast cancer type and probability of success for various treatments (customized therapy).

Now, Myriad has agreed to release BRCA gene SNP data of individuals to the individuals.  It seems this additional information is of little or no value to the individuals.  And, it would take a concerted effort among a large group of patients to get enough data out to provide a statistically useful database.

Eventually, a more public database will be generated by someone.  Until then, Myriad may still have the most reliable BRCA analysis in the market place.

September 2, 2016

Do You Have to Dog Fight to Be a Fighter Jet?

Everyone has heard the story that when the F4 phantom jet (Vietnam era) came out, the theory was that machine guns/cannons were outdated because there would never be a dog fight because the new air to air missiles would kill the enemy before they ever got close.  To the surprise of many, the F4 often wound up in close up dog fights and was helpless (except for after burners).  The missles did not

work with close targets.  A gun was eventually added to the F4.  The lesson was learned and all fighters in the U.S inventory still have machine guns (am I right?). 

Now, we don't need maneuverability because again, there will be no dog fights.  The F35 is designed to be a pop up fighter (especially the Marine's version), and a stand off fighter.  Do you suppose the F35 will never pop up in proximity to an enemy fighter, or visa versa?

I am no expert.  Maybe we could have an F22 Raptor escort each F35.  Maybe we could rename it the B35 or the A35?

All that aside, my main problem with the F35 is it is not pretty enough.  Nor was the F4.  What a coincidence. 

September 1, 2016

Analgesic Contest - One Wins, But None Actually Work Well

It seems the big seller acetaminophen (Tylenol) barely works for any indication.  None of them do much for chronic pain, but ibuprofin (e.g., Advil) may work the best.

Just looking at the chemical structures, I have stayed away from ibuprofin and acetaminophen because they look hard on the liver; with their nitrogens and rings. 

For me, I take just one aspirin and it usually resolves my minor acute aches and pains.  There is the bleeding thing, but what the heck.  I remember, when I was in medical technology training at Long Beach Memorial Medical Center, we did a bleeding time on one of the students.  Then we gave her an aspirin and took her bleeding time the next day.  It was more than doubled. 

Remember "children's Aspirin" (you know Aspirin used to be a trademark, until it became a generic noun and lost its registration)?  It was accused of causing Reye's Syndrome, so they switched kids over to Tylenol.  Hmmm, kids Are more susceptible to the placebo effect.  Now, they still sell a lot of children's aspirin (83mg) for people on an "aspirin regimen" to reduce blood clots. 

August Entries:

August 31, 2016

Gene Correlations to Facial Characteristics Provides Description of Source Person - For Wanted Posters. 

They correlated enough features (mostly distances between facial features) to genes for a good guess as to what the source persons looks like. 

Can you think of any uses for this other than for wanted posters? 

It is really not such a big deal; all us white crooks look alike. 

August 30, 2016

Information Trickles In On the Behaviors of the CRISPR System

No big surprises. 

Guide RNA is more stable in a complex with protein (Cas9) than on its own. 

Guide RNA mismatches with target result in lower retention times and decreased likelihood of cutting.  

August 29, 2016

Tired of Conclusory Rejections? - So Is the Federal Circuit Court

MPEP 2144.03 allows Examiner to rely on "common knowledge" and KSR International Co v. Teleflex (550 U.S. 398; 82 USPQ2d 1385), leaves room for use of "common sense" in application of cited references in combination.  However, this always seemed non-sense to me.  If something is such common knowledge, why doesn't the Examiner just cite one of the apparently ubiquitous sources of this knowledge? 

In many of the art groups, the Examiners reject all claims all the time (at least in the first Office Action).  If they can't think of a reason to reject a claim, they will simply provide a conclusory statement that it is obvious, without the use of any facts.  At this point, Applicant must note for the record that Official Notice is not accepted of facts not on the record.  Note that the Examiner has not stated a full case (e.g., all limitations, motivation for a combination, and no expectation of success).  In particular note that the Examiner has used no facts, and then provide your own facts contradicting the rejection.  If the Examiner is then not "persuaded", at least you will be in good condition for an Appeal (try the new Post-Prosecution Pilot Program (P3) first).

In the case at hand, claims identify a first type of information and associate it with another type of information.  The Examiner presented a teaching in the Pandit reference (5,859,636) that a computer could recognize characteristics of data (e.g., phone numbers) in a document, then suggest uses for the data.  Based on Pandit alone, the claims were considered obvious as a simple matter of common sense in light of the Examiner's suggestion that one could modify Pandit to include a preliminary step of searching for the identified phone number in an address book "in order to avoid multiple entries of the same address."  The Examiner said it was common sense to solve a problem not in the cited art by taking a step not in the cited art.  The Appeal Board agreed, but the Fed Circuit did not.  

The Fed Circuit said the Examiner could not pull a claim limitation out of thin air.  I also note that the Examiner was doubly deficient because he also pulled a motivation for the combination of limitations out of thin air.  The Examiner could not point to a source of the "common" sense to solve a problem not raised in the prior art with a claim limitation not found in the art.  The statement is conclusory and without supporting evidence suggesting one of skill at the time saw a problem that leads to the suggested solution. 

MPEP 2144.03(C) goes on to say If Applicant Challenges a Factual Assertion as Not Properly Officially Noticed or Not Properly Based Upon Common Knowledge, the Examiner Must Support the Finding With Adequate Evidence.  It is never appropriate to rely solely on “common knowledge” in the art without evidentiary support in the record, as the principal evidence upon which a rejection was based.

Always challenge conclusory or empty assertions necessary to an Examiner's rejections.  This should only have positive outcomes.  The Examiner may be able to dig up evidence, and that is good because at least you have facts against which to make specific arguments (e.g., primary reference rendered non-functional).  Most commonly (in my experience) the Examiner can not provide any evidence for their required modification of the primary reference, but they still pretend they have stated a case.  Less commonly, the Examiner desperately presents an illogical (comical) set of facts.  In these cases, it is best to confront the Examiner gently in an Interview, then go over their head (P3 or Appeal Board) if they can not state a logical case based on facts from the prior art.   

Ironically, there is a flip side to this scenario.  Have you ever had the Examiner disregard your statements as only "opinion of applicant's attorney"?  This usually occurs when you (and the Examiner?) know that it is common sense to one of skill in the art that presented FACTS (e.g., found in their own cited references) would lead to the stated result, rendering the claims non-obvious.  

August 25, 2016

Can a Claim Feature "Comprise" Materials "Consisting Of" Markush  List Members?

A device comprising ... a structure selected from the group consisting of ...X, Y, and Z.  Pretty straight forward. 

In the case of Multilayer Stretch (U.S. 6,265,055) the stretch film comprised ... inner 5 layers selected from the group consisting of 1, 2, 3, 4.  The film comprised the layers, and the layers consisted of alternate selected materials.  But can the materials be blended?

The "consisting of" language required 5 inner layers to only include any of the four alternate materials.  This seems to be old news.  In my opinion, this would not exclude a sixth inner layer with a different material, as long as there are at least 5 inner layers made of materials 1 to 4.  In fact, the inner 5 layers could consist of only 1 of the four materials (with a different material between them since the claim also requires the inner layers not to border another layer of the same material).   

Apparently the controversial issue was whether any of the 5 inner layers can consist of a blend of two or more of the 4 materials.  I would say not, since such a layer would comprise two materials, but not consist of a material selected from an alternative in the group.  If the claim writer wanted to allow blends, the Markush group should have said "selected from the group consisting of 1, 2, 3, 4, and a combination thereof."

However, the Federal Circuit disagrees with me.  And, their reasoning is sound.  The Fed. Circuit was willing to look at the claims in light of the specification (something Examiners do only at their convenience, by the way), and interpreted the claim in light of the fact that blends are frequently discussed in the specification and finding nothing in the prosecution history to suggest that blends are excluded.   

So, to make the claim more clear, the film comprises 5 inner layers, and each layer "comprises only" material selected from the group consisting of 1, 2, 3, and 4.  Apparently some Examiners reject such language, but it means what it means.  There are 5 layers each comprising materials limited to only the 4 materials.    

Anyway, know that the Fed Circuit says a Markush claim in not written in stone and interpretation can be influenced by the specification.  Great, the objective is now subjective.  Thanks Judicial branch. 

August 24, 2016

Another Way Hyperglycemia Can Cause Inflammation and Disease

Some time back, I read an article on how hyperglycemia causes insulin to push glucose into adipose cells.  When the person gets obese, blood circulation is poor in the adipose tissue and inflammation results.  The inflammation is a source of cytokines that result in degradation of tissues all throughout the body (heart disease, Alzheimer's).

Here, advanced glycation endproducts (AGE) result from chemical glycosylation of proteins or lipids.  The most common example is glycosylated hemoglobin (hba1c), but similar glycosylations are generated all over the body depending on glucose levels.   

The body has systems to remove abnormal proteins, and cleaning up debris seems to involve inflammation wherever it occurs, inside and outside of cells.  Inflammation leads to ageing.  Here, the scientists are looking into the effects of AGE on many diseases, such as Alzheimer's and bone disease.

Interestingly, the best preventative to date for Alzheimer's and thin bones is Exercise.  Hmmm, and exercise reduces glucose, obesity ... 

Reduce quick carbohydrate intake, and exercise. 

August 22, 2016

Ban Lifted on Federal Funding of Human/Animal Chimera Research

Hmmm.  How to get human[ized?] organs. 

Apparently CRISPR has been used to provide pigs with up to 62 human genes.  I assume they are mostly for peptides (such as major histocompatibility antigens, MHC) that are presented on the outside of the cells.  So, do they want to permanently transplant these organs into sick people or use them as bridge organs while patients await a human transplant?  In any case it seems strong immunosuppreession would still be required.  Or, could these pigs be the host for growing a fully human organ (from stem cells, embryonic tissue, repopulated tissue scaffolding, or printed organs)? 

It seems that research using human embryonic stem cells hESC still will not be funded, and nor will research funding include insertion of pleuripotent human cells into primate embryos before the end of the blastocyst stage.  However, it would be allowed to make other chimeras using stem cells not derived from human embryos.  The NIH is taking comments on the new policy:  https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-18601.pdf

Also see NPR article at:  http://www.npr.org/sections/health-shots/2016/08/04/488387729/nih-plans-to-lift-ban-on-research-funds-for-part-human-part-animal-embryos .

August 21, 2016

Advance in Prosthetic Heart Valve Design and Installation (Video)

Prosthetic heart valves have come a long way from the old ball in a metal cage design. 

Great materials and design are used in this version of heart valves.  Looks like laminar flow is maintained in a more natural design.  The interesting technique of implanting requires only 3 sutures.  I suppose the complex surfaces of the base are intended to be infused with fibroblasts, and such, to ultimately provide hermetic integration with heart tissues.  I assume there are a lot more sutures reconnecting the aorta. 

Check out the video.

August 20, 2016

GMO Food Labeling Law signed.  Now Everyone is Happy 

GE labeling.  I believe the labeling only applies with gene transfers across species, such as BT corn.  Meat is exempted, so no labeling of that fast growing salmon? 

Warning label can be a smart phone readable bar code.   Labels or advertisements can not claim GE free is better in quality or safety.  See the Senate version at:

https://www.congress.gov/bill/114th-congress/senate-bill/764/text

The law is short on details and leaves it to the FDA to promulgate the specific rules. 

The good news is that the rule would provide unity across state lines.   The rule seems reasonable.  People might calm down about GMO when they find out that 80% of what they eat is GMO ...  and see how healthy they are.

August 19, 2016

Patents, the Friend[?] of Patients in the Developing World

At least one voice in this article admits that patents are not the main cause of poor medicine access in the developing world, and patents are actually part of the solution.

The article did not get in too deep, but from my experience, drug patents benefit most of the world for free.  Drug patents prompt publication of drug compounds and methods of manufacture.  Most inventors do not actually file for patents in most developing countries, so they are free to practice the inventions there. 

If it were not for the development of AIDS drugs in countries with patents, there would be NO access to these drugs in any developing countries.  The article also mentioned that "[p]atents not only foster pharmaceutical innovation, but also inhibit counterfeiting and fake drugs, which are widely recognized as serious barriers to access to high-quality drugs."

The bigger problem, of course, is the lack of money and resources in general for treating patients.  It is not asking too much, even for poor countries to set aside at least 15% of their resources for medical care.  This would not solve all problems, but there are a lot of cost effective (low hanging fruit) treatments for poor citizens, if the governments can set their priorities wisely.  

August 18, 2016

FDA Recommends Clinical Assay License Applicants Make Public Their Gene Sequence Correlation Databases

Because recent Supreme Court decisions have made it hard to patent personalized medicine inventions, it may be difficult to encourage the deposition of variant information in into public databases.  With patent protection questionable, the strongest remaining intellectual property may be trade secret protection.

Any requirement that all databases be made public may be a disincentive for development of methods to identify appropriate personalized medicines.  Because the claims including correlations between gene sequences and disease states are difficult to patent, there is an incentive to retain the correlations as a trade secret.  For example, although Myriad BRCA breast cancer detection methods were held to be ineligible subject matter for patenting, I believe Myriad still holds onto a market using their proprietary mutation database.

The proposed Guidelines say the FDA recommends license applicants make public their genetic variant database in support of their next generation sequencing (NGS) based assays.  I suppose this provides for more peer review to help confirm validity of the assays.  However, why would someone go through the time and expense of licensing a diagnostic or treatment method, if anyone could copy it?  More innovation could probably be provided if developers were able to confirm correlations of diagnostics to disease states without providing all the data in their database to the public.

 See proposed Guidelines at:    

https://www.personalizedmedicinebulletin.com/wp-content/uploads/sites/6/2016/08/FDA_IVD.pdf

Reading between the lines, the "recommendations" in the proposed guidelines may be suggesting that the FDA may penalize license applications that do not disclose all of their intellectual property.  I hope this is not so.  I am no expert.  Any comments?

August 17, 2016

Just Because You Shoot Them With a Stun Gun Doesn't Mean You Don't Care

Seems reasonable, in concept, to monitor the hearts of stun gun patients.  EEG and body temperature might be interesting too. 

It would be technically challenging, though.  For example, the read out would vary quite a bit depending on where the electrodes happened to implant.  But, I guess a basis heart Rate would be easy to detect.  Too bad the information might often be a little late.   

One thing is for sure, the hardware still needs some miniaturization.

August 16, 2016

Go Ask Alice - E-mail Receipt Method Claims Eligible

The Federal District Court in Massachusetts found claims eligible to a patent, e.g., with claims to confirming transmission of an e-mail to a recipient.  See, e.g.:

https://www.google.com/patents/US8209389?dq=8,209,389&hl=en&sa=X&ved=0ahUKEwiatPeOhb_OAhVKyWMKHeDyCxkQ6AEIHjAA

The claims seem to only recite computer implemented steps with servers being the only hardware.  These claims would not be allowable in the Patent Office today (even if they were inventive), but sometimes the courts are better at interpreting the Supreme Court than the Patent Office. 

Back in 1999 (priority date of patent), the steps of sending a message and confirming the servers have transmitted and received the message may have been considered inventive.  This may be all that saved the patent claims.

In my current practice, I use obviousness based arguments to demonstrate "inventiveness" of claims alleged to include patent ineligible subject matter.  It actually helps if the Examiner has also included section 103 obviousness rejections of the same claims.  I argue non-obviousness against the Examiner's best prior art references, then follow up with my arguments against the patent ineligibility rejections noting the claims are inventive (non-obvious "something more" than the natural phenomenon); also including a strong argument that the claims do not monopolize the natural phenomenon. 

Anyway, it is nice to see a software patent beat an Alice challenge, for a change. 

August 11, 2016

HIV Nucleic Acids Protected Inside Capsid, Replicating While Inside Host

I always imagined that all viruses left their capsids at the door or cast them off once they started their metabolic tasks.  I mean, how do the virus' few proteins (e.g., reverse transcriptase and integrase) get out to do their work?

The capsid has pores like a camera shutter that let in nucleotides from the host, while keeping the virus genome hidden from host cell defenses (ribonucleases).  The pore channel is strongly positively charged to attract host nucleotides and the whole capsid would fall apart if not stabilized by the rapidly inflowing nucleotides. 

This explains a lot about how HIV stealth works.  This also presents a great opportunity for development of new anti-HIV drugs. 

See abstract and Figures at:

http://www.nature.com/nature/journal/vaop/ncurrent/full/nature19098.html#access

August 9, 2016

Please Release Me ... Super Bug

Stop the SuperBugs.  Don't let them attach to the outermost layer of skin.  Blocking adhesion at tetraspanins resulted in a bacterial burden reduction by about 50 percent. 

Wow!  And I just reduced my bacterial burden on my outer keratinocyte layer by 90% ... by washing with soap. 

Somebody please impress me.  I am tired of my sour grapes responses.  For example, this technique may reduce bacterial adhesion, but doe not appear to distinguish beneficial bacteria from pathogens, and is less effective than simpler techniques. 

August 8, 2016

Just In Time (Well, Next Day) Manufacture of Personal Biologic Dosages

The journalist article was not too informative, but I did find the actual Nature Communications article:

http://www.nature.com/ncomms/2016/160729/ncomms12211/abs/ncomms12211.html

Without reading, I imagined essentially a stir flask fermentation feeding into an affinity column to purify the peptide product. 

The actual "proof of concept" for the on demand drug manufacture system was something different.  The system has a complex microfluidics system to culture the yeast host, and essentially no purification step beyond filtration through a porous membrane to keep the yeast out of the perfusate product.  Pichia pastoris was a great choice for expression host because it is very stable lyophilized, and can express and secrete eukaryotic glycoproteins. 

By the looks of the protein gel at Figure 5, the perfusate (filtered conditioned media) product is about 60% pure with the desired bioactive protein.  I was a process engineer for a lot of years and 95% purity was usually the milestone for pharmaceuticals.  The other 5% was usually mostly other forms of the product protein, but aggregated or fragmented. 

I haven't given it as much thought as the authors, but it seems they could put less effort into the fermentation of the yeast and more into purification of the product. You could go far in purification steps with all those fancy microfluidics; and it seems the yeast could grow well enough without them. 

As far as availability of drugs goes, the proof of concept may have a niche, e.g., where the drug can't be lyophilized, is very unstable, and you don't need the product for at least 24 hours.  Otherwise, it seems a good lyophilized product would be more available and as easy to store as the lyophilized yeast and process reagents.  (Boy, I've been sour grapes lately.)

One cool aspect is that the expression system includes selectable alternate products using alternately inducible promoters.  Depending on chemical signals in the media, the yeast will produce different desired bioactive products. 

August 4, 2016

EPO Rules On Claim Amendment Support Made Less Strict? 

In my opinion, the European Patent Office is an outlier with the strictest rules on support for claim amendments.  I hope this good news is for real.  We have had false hopes in the past that Europe would join the more reasonable community.    

The EPO rules are essentially the same an U.S. rules.  For example, "a claim should be regarded as supported by the description unless there are well-founded reasons for believing that the skilled person would be unable, on the basis of the information given in the application as filed, to extend the particular teaching of the description to the whole of the field claimed by using routine methods of experimentation or analysis." 

Instead of following this rule, the EPO has been using an extremely strict and arbitrary "unambiguously derivable" standard of review, essentially where support is only found in exact descriptions of the amended claim, e.g., in the same paragraph or sentence.  That is, suppose the specification generically described a cake with a flour, egg, and sugar.  Then, described alternate flours (GP, wheat, cake), sugars (powder, table, brown), and eggs (white and brown) in other paragraphs or sections of the specification. If a claim to cake with whole wheat flour; brown sugar, and white eggs was amended to change the flour to GP flour, the EPO would say the cake with GP flour was not supported in the specification.  This, unless that combination was specifically and separately described (inexplicably termed "unambiguously derivable") in the specification.  What is underivable about choosing the alternate flour from the paragraph dedicated to listing alternate flours?  It got so bad that I would write special specifications (Europeans needed special help) laboriously writing out claim feature combinations and permutations in boring monotony. 

The new EPO Guideline paragraph (H-IV 2.3) is as follows:

“When assessing the conformity of the amended claims to the requirements of Art. 123(2), the focus should be placed on what is really disclosed to the skilled person by the documents as filed as directed to a technical audience. In particular, the examiner should avoid disproportionally focusing on the structure of the claims as filed to the detriment of the subject-matter that the skilled person would directly and unambiguously derive from the application as a whole.” 

So, the Examiner must look at the application as a whole, not just for en express copy of the amended claim in the specification. 

Just to be safe (and to have support in China), don't forget to include multiple dependencies on top of multiple dependencies in claims for PCT and EPO.  Somehow, they think this strange geometric structure (e.g., of Markush claims) supports the amendment, while the better organized and explained original specification does not.

August 3, 2016

Pioneer Inventors Should Get Broad Claim Scope, but Be Careful in Coining Terms Not In the Art.   

It is old news that if an Applicant makes up his own terms (being your own lexicographer), their scope is limited to the description in the specification. 

If terms must be made up in an application, I make a point of having an entry in the Definitions section of the application stating my preferred scope of the term.  This is a difficult paragraph to write.  I will also have examples, and in some cases use of the term in broader and narrower scope than in the Definitions section, as back up positions (I know, be careful).

Claim differentiation (parent claim must have broader scope than the dependent) is mentioned in the article as a way to imply broader scope to a term.  However, I expect that this alone would not expand scope, if there is not support in the specification.

I have had clients with pioneering inventions who had to make up their own terms.  This can be a huge problem, especially if the client initially filed their own application pro se.  However, I have still been able to issue claims with good scope laying the proper history in the file wrapper, and using the Figures, the "totality" of the specification, and external evidence as viewed by a cooperative Examiner. 

August 2, 2016

Proposal: Government Should Step In to Use Patented Drugs and Pay By a Formula 

I was ready for another of those articles where the author suggests the government take away rights to a drug and then also be the one that determines how much compensation to pay (thank goodness for the just compensation requirement of the 5th amendment). 

Well, I was right, but also surprised.  The author actually acknowledged that the just compensation should include not just the cost of manufacture, but the cost of developing the drug, AND the cost of the drugs that failed (risk of drug development).  Wow.  Now I've seen everything:

"We suggest that the government offer patent holding companies compensation keyed to the amount invested in the relevant drug, adjusted for the risk of failure and to permit companies to earn reasonable or average profits ... /span> producing more efficient prices."  (Efficient?) 

The article suggested a multiplier, where a company that invested $500 million with a 1 in 10 chance of success (one estimate of the success rate for drugs entering Phase 1 trials) could earn up to $5 billion (plus even a little more as a profit margin).  The approach to compensation under the suggested statute should focus on the cost of R&D, and not on the cost-effectiveness of drugs.  (What if the cost of R&D price was higher than the cost effectiveness based price?  Would no one get the drug?)

Most drug companies make a reasonable profit, in line with those of other businesses (start ups mostly go under).  Just because there have been a couple of episodes where company charged too much for a drug does not mean we need to create a new Department of Drug Pricing.  

Even the famous Daraprim case (anti-parasitic going from $14 to $700) did not require government intervention.  The company was embarrassed, an alternate compounding pharmacy stepped in at a lower price (and the CEO was ultimately arrested on unrelated charges). 

And, as with many government programs, there would be perverse incentives.  My motto is "don't reward bad behavior".  This is how I raise my kids.  Don't motivate manufacturers to be inefficient, knowing their costs will be part of a payment formula.   

Drug discovery in the U.S. is a goose laying golden eggs.  Best to leave success alone.  The main unreasonable phenomenon is when other countries feel free to take the drugs at only the cost of manufacture.  Then, ignorant U.S. politicians and "activists" wonder why U.S. patients pay more for drugs. 

August 1, 2016

Needle-Less (or Needless) Blood Sampling Device

When I worked at medical centers as a Medical Technologist, years ago, we commonly drew blood from branch lines of catheters.  So, not much new here. 

I looked up the patent application (US20160051174 - https://www.google.com/patents/US20160051174?dq=inassignee:velano&hl=en&sa=X&ved=0ahUKEwjsy-SRj5zOAhVi44MKHTPmC70Q6AEIHjAA

) but Google was not showing the application drawings.  

I went to the USPTO site and see that the catheter has a needle (so the device has two needles, not needle-free) in an accordion housing so it can be pushed forward to intrude into a space at the front of the catheter.  I guess the sliding needle mechanism has a seal to close off catheter fluid flows while the blood is being drawn.  Still, it seems that one would still have to draw a significant amount of fluid back to waste before catheter fluid was no longer significantly contaminating the blood draw. 

A minor improvement over old technology, if it is cost effective. 

June/July Entries:

July 31, 2016

More Titanium Body Parts.  We Can Make Him Stronger!

When I saw the article image of the prosthetic rib cage, I was impressed by the lack of porosity in the 3D printed material. 

Then, the photo showed the roughness.  In the old days, microenvironments for microbe growth were a big issue.  It seems like lately there is less emphasis on smooth surfaces.  Of course some texture is desirable at interfaces where bone is expected to form a bond with the device.   

Anyway, you have got to love the versatility of 3D printing in the medical device field. 

July 29, 2016

Last Universal Common Ancestor (LUCA) of Life Confirmed in Gene Studies

The most ancient common array of genes in Archaea and prokaryotes are a set that one would expect to be found in a cell living in a hot anaerobic environment.  This conveniently fits with the environment found on Earth at the time life emerged.  The authors suspect the early life lived in the dynamic environment near undersea hot vents.  So much of the warm soup in the shallow pools theory I grew up with. 

There was no free oxygen to boost the redox potential in the environment, but the organisms must have found enough potential differences between the different forms of iron, sulfur, and hydrogen, to get by, one electron at a time.  No light required.

The paper also seems to confirm that the first form of life was not a eukaryote. 

July 28, 2016

Buying Your Own Medicine is Not an On-Sale Bar to Patent Eligibility.  

I was a little surprised when the  Hamilton Beach Brands, Inc., v. Sunbeam Products, Inc. case came out in 2013.  The patent holder busted the on sale bar by buying his own invention from the outsource manufacturer in China. 

This case seems may have a slightly different fact pattern, e.g., the Court characterized this transaction as a contract for a manufacturing service, while in Hamilton Beach, the Court saw the manufacturer selling the inventor the goods. 

I am not sure if the UCC definition of a sale helps much here.  "[a] sale is a contract between parties to give and to pass rights of property for consideration which the buyer pays or promises to pay the seller for the thing bought or sold."  The Medicines Company facts could just as well been considered a sale of the drug product to the inventor. 

In fairness, I think the Hamilton Beach case was a blindside attack.  Invalidating a patent for the inventor buying his own product from a foreigner.  It seems the Medicines Company Court got it right in seeing that the "thing" sold was a service and not a product. 

July 21, 2016

Broad Ranging Review of Air Traffic Control and the Airlines

Some of the information seems slightly dated, but an interesting read.

Was interesting to see comparisons of ATC systems in different countries.

I am prechecked (required to fly GSA off of Oakland North Field).  My wife has gotten a  TSA PreCheck for $85, but I had not heard of the U.S. Customs and Border Patrol's Global Entry program for $100.  This gives faster security And customs treatment. 

Better baggage tracking might be nice, to reduce baggage loss.  However, on my last flight to Heathrow, my bags did not make it because the Vancouver hub timed my flight from SFO too close and decided it was too much trouble to get my bag on board (though my wife's made it).

The air up there - I flew on a 787 dreamliner last trip.  The bigger windows and higher ceiling were nice.  The liquid crystal dimming windows were cool, but I was disappointed by their reset time; took a while to go from dark back to transparent.  Best was the air pressure was higher and humidity higher.  That made a difference in my dehydration and sleep.

Now, If They Could Just Devise a Faster Way to Deplane. 

July 15, 2016

Gilead Absolved of Guilt for Not Marketing Drug Fast Enough

Not all business decisions meet the standards of the purest ethics.  Still, Gilead did the research, development, and licensing to provide the world with improved AIDS drugs.  Maybe, not on the time line of the less productive holier than thou. 

The Court found that the company “had no obligation to introduce the improved product at an earlier date.”  I am not sure what was the basis of the suit.  Intentional infliction of emotional distress?

I assume Gilead had patent applications running toward their 20 year expiration and were motivated to get the new drug to market.  After that, it becomes public property.  Thanks.

July 11, 2016

Sensitive DNA Forensics Can Be Sooo Insensitive.

With PCR to sensitive DNA sequencing techniques, I bet every square inch of a hand rail of a commuter rail station has detectable DNA for 100 persons.  If there is a murder committed at the station and the victim brushes against the hand rail when being carried out, does this make 100 people guilty of Murder? 

Good police work will continue to require consideration of motive, opportunity, presence at the crime scene, timing, and witnesses.  I wonder how many innocent people have been wrongfully convicted based on DNA evidence.  More than have been exculpated?

June 9, 2016

Scientist/Lawyer Makes $200 Million Mistake [By Lying?] About HepC Drug

Two drug companies pursuing treatments for the same disease indication can have trouble talking to each other, e.g., for a collaboration.  Non-disclosure agreements (NDAs) can be signed to keep the conversations secret.  The collaboration agreement can stipulate which party get to use the fruits of the collaboration.  It is best to have a patent application filed before discussing your improved technology.  A party that has a previously filed patent application will have a strong position to prove inventorship, but this can still be rebutted, even in the new world of "first to file". 

What if one of the parties is dishonest?  Some Big Pharma are so big that they can promise to keep information received in one part of the corporation (licensing) from personnel in another part of the corporation (research) by building a "firewall" between the parts.  However, in this case, a Chemist, who was also Patent Attorney, was apparently on both sides of the fire wall.  And, it seems he elected to incorporate into a patent application intellectual property from confidential collaboration disclosures into a Merck patent for an HCV nuclease inhibitor molecule structure.  Then, the patent was used to sue Gilead for infringement of the claimed nuclease inhibitor.   

That is all well and good (not really).  But, not telling the truth does not work so well in the Courts or at the Patent Office.  If any owner of a patent lies, e.g., about inventorship, the Patent Office is likely to invalidate the patent completely when the lie is discovered.  Moreover, if you lie about key facts in a Federal lawsuit, you can lose all of the damages awarded in the lawsuit (e.g., $200 million), and then some. 

I assume the Chemist/Attorney will be lucky to keep his law license.  There will likely be more consequences for his employer (Merck), unless there is a successful Appeal.  The patent is invalidated. 

Lying (oops, I mean "intentionally fabricated testimony") is not good business. 

June 6, 2016

Functional Features Can Be Part of a Design Claim

Looking at the life vest design in question, it may actually be considered to be made up entirely of functional features, but in an ornamental combination of structural relationships.

See the Design patent involved in the case discussed at: https://www.google.com/patents/USD623714?dq=D623714&hl=en&sa=X&ved=0ahUKEwjL0KTVw5HNAhVISyYKHZylDUQQ6AEIHTAA

Design patents protect the ornamental non-functional aspects of an object.  It is often hard to decide what parts of an object, subject to a Design Patent, should be in the solid lines for the claim drawings, identifying the claimed ornamental aspect.  This case says you should not be afraid to include structural lines from functional features as PART of your claimed ornamental design claim. 

A pretty functional set of life vest features were included in the Design patent held invalid in the District Court.  However, the Federal Court overturned saying, "district court improperly converted the claim scope from one that covers the overall ornamentation to one that covers individual elements".  This makes sense. 

For example, suppose crossed swards ornamentation also provide cross braces for table legs.  The sword blades are functional, but the over all ornamentation includes the entire swords, including the blades. 

In Utility patent claims we often include parts that are not the inventive aspect, but necessary to putting the invention in context.  We are not claiming the non-inventive aspect, but using it to help define the invention.  So, it seems reasonable to allow functional features that provide part of the overall ornamentation in Design patents. 

June 1, 2016

Stroke Patients Show Dramatic Improvements with Allogenic Support Cell Implants

The article does not seem to make it clear, but the "stem cells" are not from the same patient, but mesenchymal stromal cells from someone else's bone marrow and transiently expressing a notch1 intracellular domain. 

See more on the SB623 support cells at:

http://www.san-bio.com/news/documents/MSCs%20and%20SB623%20cells%20rescue%20neural%20cells%20via%20trophic%20support%20(Tate%202010).pdf 

The cells apparently do not become parts of new neuronal pathways, but merely provide trophic support for the stroke damaged brain cells to get better.  This, up to 6 months after the actual stroke.  Then, the support cells seem to gradually disappear.  No mention of possible immunologic issues from the allogenic transplant (brain immune privilege?).

I guess the most interesting part of this work is that months down the line, remaining non-functional neurons can be brought back to function with a little help from support cells.  Like little nurses helping them to get better from a chronic illness.  Got to love 'em.   

Maybe spinal chord severance injuries could be improved with a cocktail of the patient's own neural stem cells in combination with these support cells?

June 1, 2016

Glucose Sensor in Contact Lens (Cure for Diabetic Retinopathy? - NOT YET)

The general idea of monitoring tear glucose is a good one for real time responses to diabetic blood sugar levels. 

"The circuit has four components: an electrochemical glucose sensor, microcontroller chip, drug-delivery system, and an inductive coil to receive wireless power from the glasses. .... Tests of the sensor placed in an artificial tear solution showed that it worked accurately, with no drop in current, for three weeks when the researchers repeatedly spiked glucose levels." 

That is all well and good for a prototype.  The "tests" only showed that the sensor could be powered for some period of time.  I assume the glucose sensor uses an enzyme (e.g., glucose oxidase driving measurable current at a silver electrode).  Significant levels of glucose would prompt release of insulin (osmotic pump?).  This seems to have been of no practical benefit, so far, and not actually reduced to practice.  Suppose the device released some insulin from the "drug delivery system", how much insulin is there and where would it go?  There could not be a significant amount of insulin in the device.  Even if it were to treat only the eye (much less, the whole body), I assume there would be no significant penetration and would all be washed off the corneal surface and out the lachrymal duct. 

The device is powered like an RFID using electromotive force from a coil in the glasses.  (This, while brain cancer from cell phones is in the news again.) 

The sensor probably works, but not the diabetes treatment.  It seems this could work if they could make the lenses cheap and design the glucose detector component to last at least a month.  The sensor could send a signal back to the glasses, which could signal a more macro-scale glucose pump on the patient's body with enough insulin to control whole body glucose levels. 

Easy for me to talk.

 

April 29, 2016

lcnRNA Double Strand Break Repair Mechanism Protecting Resistant Cancers

Certain cancers, such as triple-negative breast cancer (TNBC, negative for select therapy targets), are also resistant to attacks on their DNA because of a DNA repair mechanism that is up regulated. 

In this article, it is suggested these cancers can be less devastating if we can find a way to inhibit the DNA repair known to use the long-encoding RNA (lncRNA) mechanism.

Seems there would be side effects too, but acute therapeutic attacks on the target cancers are probably a risk worth taking to close down this DNA repair mechanism protecting the cancer.

April 23, 2016

Another Chance for Diagnostics Patent Eligibility at the Supreme Court?

The unanimous Supreme Court (SCOTUS) case of Mayo v. Prometheus was bad law based on bad facts.  The claims (poorly written and confusing) were essentially directed to detection of metabolite levels (ironically of an unnatural drug) in a patient to see if the drug is in a therapeutic range.  Now, we have to live with this unusual fact pattern for comparison in determining patent eligibility for diagnostic tests. 

From Mayo came a set of Guidelines at the Patent Office (http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf ) that should have been good news.  The SCOTUS had at least laid out policy priorities from which weighted factors were to be considered in evaluation of eligibility.  Key among these factors were "inventive concepts" (non-obviousness) providing something more to the natural phenomenon, and lack of natural phenomenon preemption (not monopolizing the phenomenon).    

The article suggests that Sequenom may be a good poster child to argue against over recent aggressive findings of diagnostics patent ineligibility.  The Sequenom claims are methods specifically requiring a maternal blood sample be split into several reaction chambers and the reactions to be evaluated for the presence of both maternal and fetal chromosomes, and the chromosomes evaluated for aneuploidy.  These claims seem far from monopolizing the phenomenon of fetal cells in maternal blood.  The inventiveness may be arguable. 

See the Sequenom patent at: https://www.google.com/patents/US7888017?dq=7,888,017&hl=en&sa=X&ved=0ahUKEwi8odqTvqLMAhUB1WMKHdTFCo0Q6AEIHTAA

The problem I have seen with the court cases and in prosecution of diagnostics patents lately is that the Examiners and Judges seem afraid of Mayo and do not even attempt to apply facts to the guideline factors.  They just wave their arms and say there is a natural phenomenon analyzed by well known techniques.  I have had some recent cases where the claims are focused on a particular use of a natural phenomenon taking up not even 1% of the phenomenon uses; and where the obviousness rejections of the claims are unsupportable.  I have discussed the cases with the Examiners and they have told me their hands are tied by Mayo and Sequenom.  It seems to be an unwritten policy of the PTO to ignore the weight of facts in their own Guidelines. 

My strategy for these cases is typically to draft very strong Appeal Briefs, using the facts and Guidelines, and hoping for a more friendly environment by the time my cases are actually decided by the PTAB (about 3 years). 

With time, the pendulum may swing.  More cases may go in the favor of diagnostics claims and Examiners may not be so frightened standing out from the crowd with an allowance.  The policy issues of non-preemption and inventiveness may be given more respect.  Importantly, maybe the Court or Congress may see the important policy issues of saving lives and keeping the U.S. at the forefront of diagnostic technologies. 

April 20, 2016

Deliver My TP Over the Top, Please

The last word (actually, first word) in how to load a toilet paper roll can be found in the original patent: https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US465588.pdf

Well, Mr. Wheeler did not actually patent the method of mounting a TP roll, or even perforated TP rolls, but only those with serrated perforations with a central trapezoidal  tongue.

However, it is clear from the drawings that TP pioneers were on the right side of history on insisting the roll egress over the top.

April 19, 2016

GMO Plants Get a DoOver in Court of Public Opinion Thanks to CRISPR

USDA did not review a non-browning mushroom and a waxy corn as biotech products since they did not contain a foreign gene, and were transformed using non-randomized insertion.  The USDA said the CRISPR-edited mushroom doesn't contain any "introduced genetic material" or foreign DNA. See article at: http://www.businessinsider.com/the-us-government-says-crop-edited-with-crispr-wont-be-regulated-2016-4  Hopefully, the position of the USDA scientists will result in a fresh image of laboratory modified plants. 

Scientists are basically in agreement that thoughtfully engineered genetically modified organisms do not pose a threat, regardless of the enzymes used to modify the genes.  Countless trials have not shown harm as food.  It seems a lot of the hype from non-scientist journalists against GMOs in the past has had to do with the fact that FOREIGN genes (chimeras!) may have been inserted RANDOMLY (careless Mutations) inserted into a familiar food plant.  This unpredictability and ungodly crossing of species has been a significant part of the fear and ick factor of GMOs. 

Don't say it out loud, but these plants are actually still genetically modified, as are traditional radioactively mutated plant varieties and cross species hybrids (yes, mules are icky).  And, even if the gene engineering is by the old fashioned restriction endonucleases, and somewhat randomly acting expression vectors, the final products can be just as well characterized and screened for theoretical hazards (almost all of which are disadvantageous to the engineered plant and not to the animal that eats it). 

What I am saying is that when it comes to safety of restriction enzyme engineered and CRISPR engineered plants, it is mostly a distinction without a difference.  It is easier to avoid unintended mutations when inserting with CRISPR, but GMOs made with restriction enzymes or with CRISPR can be essentially the same. 

However, just because the USDA gave a blessing of not reviewing this mushroom and corn does not mean they will not be otherwise attacked.  I assume they will at least have to include GMO on the label in Vermont if they become an ingredient of a processed food.  And ... these products Are dangerous.  Yes, non-browning mushrooms may not degrade as fast as other mushrooms and will have an advantage while they spread under our feet to take over the world.   

Still I can hope the press will be nicer to CRISPR technologies.  Engineers in other fields don't seem to catch as much flack from the press; probably because they don't mess with something that goes into our (and our children's) bodies, and because there is so much nostalgia and romance around food.  My bet, though, is that certain journalists (usually non-scientists) will continue making a living cultivating the villain image of laboratory adjusted organisms. 

April 18, 2016

India Realizing Compulsory Licensing of Patented Foreign Drugs is Impractical

India is apparently backing off, for now, on the threat of compulsory licensing for patented drugs it feels are over priced.  India's Commerce Ministry had forced one compulsory license.  More recently, the Petitions by Indian generic drug manufacturers were not granted with the Ministry finding the Indian generic drug manufacturers "did not make a strong enough case".  Interestingly, there have been allegations that certain staff of the Ministry had suggested to foreign pharma that they would not be granting  compulsory licenses for commercial use (leaving open emergency government use).  The Ministry had no comments when information was requested by media on the topic. 

It appears that in reality the best way for India to save money and get cooperation is to work with foreign pharma to have drugs manufactured in India.  Deals can be made to sell drugs as lower cost in India.  Deals can include foreign pharma cooperation in using trade secrets that greatly facilitate manufacture (more similar product without expensive process development research).  Further, the Indian government may be realizing cooperative behavior provides a greater net benefit in foreign investment and reciprocal respect for its own inventions (which are expanding).

Another reason there has been no movement on Petitions to require compulsory licensing is that there is apparently a new Indian intellectual property policy statement due out soon.  No use taking drastic actions when the rules may be about to change. 

With all the fear of compulsory licensing in India and other countries, we may be missing the point that by far the greatest rip off of developed world drug inventions, research, and development costs is price setting by governments in the developed world itself. 

April 15, 2016

Diluting the Anti-GMO Brand

Retail food products are hitting the shelves GMO warnings - "partially produced with genetic engineering".  What will happen when consumers realize that 70% of packaged food contains at least one ingredient derived from a genetically engineered plant?  Of course, they will eventually become habituated to it. 

If tell people no one has ever shown adverse health consequences from eating GMO plants, someone will say, "we need more studies."  This, even though trillions of GMO meals have been served without harm (far fewer incidents than for many "natural" foods). 

But, many people will eventually realize from their own experience that GMO food is not dangerous (unless they are really paranoid and blame every rash on GMO).   Real life experience can sometimes overpower fear of the bogyman.  That is, the people will be desensitized to the fear of GMOs. 

The current laws will only (unfairly) accelerate this desensitization.  For example, take soy bean oil.  If there is a protein that makes soy resistant to glyphosphate (not typically in the soy, and anyway not segregating with lipids in processing), it would not show up in the oil, which contains zero protein.  Even if the protein were present, I assume the protein could be eaten by the tablespoon, without ill effect.  Still, the law requires food made with the clearly (and proven) safe oil to be labeled as a GMO product.    

There are plenty of theoretical problems with GMOs.  But, it is hard to make up reasons not to eat well thought out GMO foods.  For example, just because a peanut or tobacco protein is in a GMO food does not mean you will get addicted, or experience a peanut allergy reaction (the protein in the GMO is not the same one known to cause the peanut allergy).   

I am not sure where the first amendment argument will go.  It does not seem unreasonable to require true information on a food label.  However, what if the information conveys unreasonable fear of something harmless?  I expect the stronger constitutional argument is that the laws are arbitrary and unreasonable vague (not well tailored to an actual identifiable problem, while forcing speech).

The bigger problem with GMOs is that they divert attention away from the real problems.  Who do you know that has been made ill by a GMO?  Who do you know that has diabetes or heart disease from eating hamburgers and fries?

Moderation in all things.  Balance.  What is harder on a family's health - buying half as much expensive organic vegetables, or eating twice as much GMO vegetables with a one in a trillion chance of causing a rash? 

April 13, 2016

Danger in IoT for Medical Devices

OK, what is IoT?  Oh yeah, internet of things - I must have been an IdioT to have forgotten. 

Anyway, with the IT prevalence in medical devices, we all know the time will come when they will be hacked.  Probably little will be done until there is a disastrous incident.  Data out from individual devices may not be the biggest problem.  Who cares what is Jim Johnson's clotting time?  Worse would be data in to change John's pace maker parameters.

Usually, it takes an incident to make people take the necessary steps. 

April 12, 2016

How Times Have Changed - Wright Brother's Flying Machine Original Patent Rediscovered

The Wright brother's original patent was lost and rediscovered.  See the text and figures at:

https://www.google.com/patents/US821393?dq=821393&hl=en&sa=X&ved=0ahUKEwjj7p3esoPMAhUS2mMKHQ56AWYQ6AEIHTAA

This is a large patent for the time.  The wings are quaintly caller "aeroplanes".  The "corners" of the aeroplanes act as ailerons when they are warped by ropes and pullies driven by the pilot shifting a "cradle" on which he is laying.  This also shifts the center of gravity of the aircraft, further aiding in the turn.  It is interesting at page 4 that the Wrights understand that turning is ailerons and the rudder is intended not to turn, but to keep the axis of the fuselage aligned with the direction of flight.  (Note, I am a private pilot.)

At page 5 they explain why they put the "horizontal rudder" (elevator) in the front of the aircraft at a negative angle. Apparently, they intended that this would increase safety by providing lift during stalls to keep the nose up.  This does not make sense to me, because a high nose is what causes most stalls.  However, this is essentially a canard design and no matter their explanation, is generally more safe if the front wing stalls before the main wing. 

Note there are 18 independent claims, ending with "substantially as described."

April 11, 2016

Storing Photos as Ternary Data on DNA Molecules - High Density Storage

The human interest article that mentioned this work was boring, so I had no great expectations.  However, once I found the actual paper, I was pleasantly surprised by the careful consideration and initial experiments to store digital data in DNA. 

Before I read the article, I guessed at the basic principles and problems, and I was mostly right.  Data is stored in short (synthesizable) blocks between PCR primers and barcodes (addresses).  To avoid the problem of primer dimers in such a multiplexed environment, large data files of several addressable blocks must be stored in separate pools, e.g., plate wells (though I have a client with certain primer blocking technology that could minimize this problem).  Then, there are the problems of homopolymers (difficult to sequence accurately) and hairpins in the stored data. 

See the actual research paper at:

https://homes.cs.washington.edu/~luisceze/publications/dnastorage-asplos16.pdf

What they (Bornholt, et al., UoW) propose is a massively parallel synthesized set of somewhat redundant (error checking) 200 base oligonucleotides with paired PCR primer sites and bar codes (random access addresses).  Even with the primer sites designed to avoid primer dimers, they still have to isolate large databases in separate physical pools.  Because the bar codes are randomly addressable, the sequencing step does not have to read the entire database to retrieve a particular sequence of interest.  This technology seems to be inspired by currently available massively parallel sequencing (Illumina) and synthesizing schemes. 

Of particular interest to me was the selection of base 3 as the encoding choice over standard binary or base 4 (natural DNA encoding - A, G, C, T).  The choice allows increased data density over binary.  More interesting is that the DNA 4th base to be used in a rotating encoding scheme inserting some randomization to reduce the sequence redundancies inherent in encoding images and text.  That is, e.g., repetitive data bytes (e.g., orange pixels next to each other in a photo) would encode as homopolymer repeats, which are error prone to read in current sequencing technologies.  Rotating encoding algorithms eliminate this as an issue. 

Working against the DNA data storage system is an apparent one time use problem.  That is, the nucleic acid being read is destroyed, or otherwise unavailable after it has been read.  Also, the best (most stable - I used to have a job setting expiration dates of drugs) storage mode is desiccated.  Dissolving a pool address, to obtain a particular data block, raises the question of whether to use it all or re-dry the left overs.  This all works against the stated goal of obtaining data compactness.    

Anyway, this is good progress.  Apparently DNA can store 100 million times the best current technology today (probably with about the same size reading devices).  This should be no surprise considering the DNA data in one human cell can encode a system of a complex animal with a super computer in her head.  We will probably be using molecular data storage for long term storage in the next couple of decades. 

April 8, 2016

20+ Amino Acids (Canonical, Unusual, and Orthogonal)

It has been long known that amber, ochre, and opal mutations of stop codon usage occurs naturally, resulting in placement of natural amino acids in place of stop signals.

And, it has been known that certain organisms use the stop codons to incorporate unusual amino acids, such as selenocysteine (UGA) and Pyrrolysine (UGA).

The laboratory of Peter Schultz (The Scripps Research Institute) has long been working with genetically engineered aminoacyl synthetase enzymes and modified tRNAs to incorporate any number of unnatural amino acids into peptides in "orthogonal systems".  For example, see a patent of his pioneering work at:  https://www.google.com/patents/US7045337 

We have all been sucked in by the bio-dogma of the 20 amino acids.  I was amazed the first time I read this kind of work. 

April 5, 2016

What to Do After Final Rejection of Your Patent Application 

I don't amend after final so much these days.  Get your amendments out of the way in a good first Response with amendments entered as of right.  Sometimes my first Response will be strong, and/or the Examiner's first search weak, so the Examiner has to present new prior art, allegedly necessitated by your amendments of the first Response.  Typically, new art would require claim amendments, but they will not be entered after final.  Still, I present the amendments and my best arguments at this stage to see what the Examiner will reveal in an Advisory Action.  You don't have to make a "showing" have a good reason why the amendments were not made earlier.  The Examiner will do whatever he wants in any case (knowing it is usually not worth the trouble to fight, and arguing against finality is heavily biased against Applicant).

One option not mentioned in the article is to file a Request for PreAppeal Review Committee.  I find some progress can be made with this option about half the time when the Examiner is clearly making a gross mistake.  The "Committee" is usually made up of the Examiner, her SPE, and a third party (not supposed to be in the same Art Group).  Decisions never are an Allowance, but often the Examiner is embarrassed into withdrawing the rejections and to make up something new, not as clearly in error.  Sometimes, an Allowance is not too far off, after a little administrative face saving. 

The After Final Pilot is a good program, because it gives the Examiner points and motivates a second look, e.g., at the claim amendment suggested after a final rejection based on new prior art. 

I have been Appealing cases a lot lately, and hardly ever using RCE.  If you have not been caught by surprise, there aren't many reasons for an RCE.  The problem is that it can take up to 3 years to get back a Decision from an Appeal (which can be returned in patent term adjustment).  Appeals are great because they are reviewed by a committee that is not biased and which understands application of facts to case law (Examiner's are not lawyers).  Also, I have had several cases where the Examiner was too embarrassed to present his Answer to the PTAB,  so he presented a path to allowance, without having to pay the $1000 fee to forward the case to the PTAB. 

Write a good specification so you have a basis for amendments, use the right of amendment after the first Office Action to place the case in condition for Appeal, talk to the Examiner early and often (they are mostly friendly and helpful, lately), Appeal when you know you are right. 

April 4, 2016

Watch Where You Step When you March In - NIH Threatens to Take Over Overpriced Drugs Based on NIH Grants

Before the Bayh-Dole Act in 1980, National Institutes of Health had all the rights to drugs developed under their grants, but only managed to get 5% licensed for clinical study (and fewer actually to the market). 

Now, the NIH may be pushing to use the contracted "march in" rights to take over patents where they deem the manufacturers charge too high a price.  It is a great threat, but probably will not happen.  Usually, this will be a political ploy to get the inventor/manufacturer to lower their price for the drug.  The NIH can't manufacture (probably couldn't based on the information in the patent application alone), and no one wants to take up the burden when Bayh-Dole does not allow for exclusive licenses. 

Still, this new NIH position has not helped the price of biotech stocks. 

 

March 31, 2016

"Flexibilities" - Avoiding Drug Patents by Manufacturing in Foreign Countries

Countries that have not invented patented drugs can use a variety of strategies to get the drugs to their people at a reduced price.  See WHO report "The Role of Intellectual Property in Local Production in Developing Countries".  The non-inventive country can reduce undesired drug monopolies by: placing barriers on patentability, placing barriers to patent eligibility, requiring compulsory licensing, pressuring cooperation from drug owners, and/or engineering around the invention.  These strategies are more or less fair, depending on your perspective.  A more common problem is that, even for drugs that are not patented in a particular country, most developing countries are not technically or administratively sophisticated enough to reliably manufacture their own drugs.  Drug manufacture can be as complicated as rocket science.

It is common for countries to exclude, e.g., methods of medical treatment from patent eligibility, for ethical reasons.  And, most countries exclude natural materials, such as unmodified bioactive plant alkaloids (e.g., turmeric extracts), from patent eligibility.  Another practice is to prevent extension of patent protection for old drugs ("evergreening") by making improvements to old drugs ineligible for patent protection.  This strategy has never made sense to me because when the old drug patent expires, anyone can practice it, even if someone has later patented an improvement.  If the old drug was just fine for 20 years, why is there a need to prevent new inventive improvements from receiving patent protection?  And, such practices are a two edged sword, also preventing the countries own inventors from patenting improvements.

Even after a valid patent is granted in certain countries, procedures are in place to force availability at a locally reasonable price.  For example, governments can establish compulsory licensing schemes where if the government deems availability inadequate, the government can determine what the government feels is fair for the government to pay for the drug.  Sounds fair.  Or, the government can manufacture the drug themselves and pay a fair reasonable government determined royalty.

I worked in drug manufacturing process development for years.  Just because a drug structure is known does not mean you can manufacture it.  Process development and scale up are very expensive.  Manufacturers have trade secrets that are not necessarily described in their patents or in public drug licensing applications.  Even if a patent is not enforceable (e.g., no application ever filed) in a small country, they may not be able to easily begin manufacturing the drug.

Larger countries that may be able to properly manufacture drugs still usually do not start their own manufacturing, for a variety of reasons.  Typically it is more cost effective to pressure the invention owner to sell the drug at a discount than for the country to make the necessary expenditures in process development, facilities, and manufacturing.  Alternately, the country can pay the drug owner (licensing of trade secrets, patents, and expertise) to cooperate in making the drug manufacturing less expensive and more predictable.  More commonly, the countries will set just the price they are willing to pay for the drug (paying only for the marginal cost of manufacturing drug, but not for the cost to discover and develop the drug) and the owner often agrees to the lower price.  This does not mean the owner was ripping everyone else off, but that it makes business sense to get the marginal gross revenue (while other customers pay for the research).  That is, the country paying the lower price is ripping off the drug owner, by not paying "Their Fair Share" of discovery and development costs. 

No matter where a drug is manufactured by the non-patent holder, it typically can not be imported into a country where the drug remains under patent protection.  For example, in the U.S. see 35 USC §227(g), wherein it is patent infringement to import a product manufactured by a patented process outside the U.S., even if the product itself is not patent protected.

An alternate route to obtain an active drug is to engineer around the patent, e.g., rather than trying to meet the standard of bioequivalent manufacturing.  For example, where a biologic drug patent claim includes a specific protein sequence, one can engineer around the patent by, e.g., changing a valine to an iosvaline in a structural part away from the active site (but watch out for the Doctrine of Equivalents).  Depending on the regulations (or lack thereof) in the country, the "new" drug may be licensed with little or no clinical data.

Nobody files drug applications in all 200 country jurisdictions.  So, it is legal to manufacture and sell most drugs in most countries, even if patents are still enforceable, e.g., in the U.S.  Yet, the drugs are typically not manufactured outside of the patent protected jurisdictions.  This is because there are many barriers to drug manufacturing besides the presence of an enforceable patent. 

March Entries:

March 31, 2016

Copyright Protection with Synthetic DNA

These ideas have been going around for a long time.  I thought the idea of putting bar coded nanoparticles in paint or valuable powders was a good one.

This idea is not well described in the article, but probably involves embedding DNA oligomers in the art media or an attached tag.  I believe I heard the same idea at least 10 years ago.  It probably came up again because useful detectors of DNA sequences have become more practical in size, cost, and speed. 

But, who needs fancy "synthetic" DNA, I am going to kiss all the arrowheads in my collection, leaving my own DNA to show ownership.  This is a major step up from the way dogs and cats have done it for centuries.    

March 29, 2016

Food Processors Beginning to Label GMOs - Gone Will Be the Dread

As goes Vermont, so goes the nation. 

Once GMOs are labeled, there will be no hidden mystery and the irrational fear will probably melt away.  We have all been eating large amounts of GMO foods for years, to no ill effect, but it has not been up front.   

No one puts even theoretically hazardous proteins in food plants for people.  The sooner GMOs become everyday in the eyes of the consumer, the better.   

March 28, 2016

China Files a Large Nomber of Patents - Wow

What an annoying article. Such puffery and misleading statements.

The first sentence is ridiculous - "The economy is not the only area in which China has claimed the top spot." ??? China has a number 2 economy. The U.S. economy is three times the size of China's. Note that if the U.S. grows at 3% and China grows at 9%, they still would never catch up (well, OK, considering that such growth must be sigmoid).

Sooo, China has a command economy with a "five year plan" to produce a number; a propaganda goal of Issuing a larger Number of patents than anyone else.  Half are "model" patents that shouldn't be equated with, e.g., a Utility patent. It's like saying you are the greatest food producer because you raise a larger number of chickens than the number of cattle your neighbor produces. Wow! What a large number you have.  But, you should see how many bacteria I have.

Yes, China is growing and has a lot to be proud of, but it should be beneath their dignity to Invent superlatives.

March 25, 2016

The Relative Carbon Burn for Electric Versus Internal Combustion Cars - Tesla Gross Polluter Fine

It seems electric is about 2/3 as carbon intensive as gasoline cars.  Not as good as most people think. 

They did mention that the production of the batteries for a Tesla is very energy intensive (e.g., mining, transporting, purifying, compounding, assembling).  Even for gasoline cars, I have figured it takes about 2000 gasoline gallons equivalent to manufacture a new car.  Assuming someone buys a new car every 10 years, I have saved more than 9000 gallons of gasoline equivalent by driving my 45 year old Datsun 240Z (sorry it is carbureted).

March 23, 2016

Another Previously Harmless Bacteria Attacks! - Elizabeth the King

Remember when Serratia was just the pink slime in your shower?  Now, a dreaded pathogen. 

This article is about a widely dispersed gram negative rod Elizabethkingia anophelis, named after Elizabeth O. King, who first isolated it  (grows well on blood agar) from a meningitis patient in 1959.  

Well, it is resistant to antibiotics.  What's with that?  The bacteria has hardly been exposed to antibiotics in human patients.  I wonder where else it may have been exposed?  Hmmm, it is widely distributed in water and soil.  It would be interesting to see what plasmids are in these resistant Elizabethkingia and where they may have come from. 

March 22, 2016

BSE, CJD, Alzheimer's, Prions

Good the transmission (not actually Alzheimer's) is through surgery, and not a more common route.  Thankfully, the article is not suggesting a more transmissible route as in CJD or BSE. 

I was raised on wild meat as a child and had some small concern about studies years ago about possible transmission from deer to human through eating neural tissues.  Still is not a good practice to eat your deceased ancestors (as in the Creutzfeldt-Jakob disease).

March 21, 2016

The Curse of Our Neanderthal Genes

Hmmm.  Bad gene.  Correlations.  Thank god they called the identified negative phenotypes "associations".  Got to love scientists.  If the article were a general circulation newspaper, journalists would say the genes cause the problems.  Right.  One gene causes depression or tobacco addiction.  Great.  I happily have 1.5% Neanderthal genes and tobacco makes me sick.  Darn my brow ridges, though. 

Must humans play the victim in every interaction?  If the Neanderthal contributions were so detrimental, how come they were the genes we retained from our ancestral indiscretions?  Just look what OUR gene contribution to Neanderthal did to them; they're extinct!

March 17, 2016

Same Pain Time, New Pain Channel

As with cancer, there is no one trick solution to pain.  The biophysical networks in the body are so complex, you often can not block a pathway without the body finding an alternate route to get a message through. 

My wife is a neurophysiologist in the field of pain for many years and she knows first hand that a single small molecule drug is probably not the answer to chronic pain.  There is hope, though, that a combination of drugs may block a main and alternate pathway to pain.

March 16, 2016

Meta Data May Be Maxi Biased

Metadata is data reviewing a compilation of other data (boring).  It can be a powerful tool in science because it can take the data from various related studies and make statistical inferences from a larger population pool of information.  

We have all heard that positive results get published but negative results do not.  We have also heard that a large portion of published research results are not repeatable.  This is not only in the field of psychology.  However, when results of related studies are biased toward a positive result, so too will be the metadata. 

In hindsight, it is obvious that the bias in result publication would have a significant effect on the reliability of meta-data.  Darn it.  I used to like metadata. 

March 15, 2016

Origami Inspired Surgical Devices

The devices are "origami inspired".  The grasping device is made of stainless steel but seems to have done away with cables and pin joints. 

I still want to see an example of a device that unfolds after insertion.  

March 9, 2016

Wholly Distinctiveness Batman!  Batmobile Character Copyright Affirmed

The copyright infringer was manufacturing full sized Batmobiles and selling them for $90k.  The defense was that a car can not be copyrighted, and that there is not enough uniformity between the various comic book, TV, and movie Batmobiles to compile them as a distinct copyrightable work. 

The Courts have found that the Batmobile "character" need not have a consistent appearance in every context, so long as the character has distinctive character traits and attributes. 

See the case at: http://cdn.ca9.uscourts.gov/datastore/opinions/2015/09/23/13-55484.pdf

There are no fine lines in copyright infringement.  In some cases, exact replication is required.  Other times, infringement only requires production of a work having a combination of distinctive traits.  It did not help here that the derivative works were unarguably intentionally profiting on the Batman context.   

How many Batmobiles would one have to sell to pay costs of this lawsuit?  

March 8, 2106

The Diverse and Unexplained World of Bacterocins

OK.  What is that black fungus growing out of the glass bowl in the article (answer below)?

The author notes that antibiotics have long been thought to provide a competitive advantage by killing or inhibiting competitors.  I still think this must be true.   

However, antibiotics are generally unstable and exist in only very low concentrations, e.g., in soil.  So, they say, could not provide an advantage.  One scientist suggests antibiotics actually "might serve soil bacteria as sources of carbon and nitrogen; in this case inactivation [of antibiotics] (resistance) is really just digestion."  I don't think so.  Why would one bacteria provide nutrition to the environment, and why would the nutrition be configured (at great metabolic cost) to fit so neatly and inhibit, e.g., specific transcription complexes?

Iron.  So important for growth.  Remember the guy who wants to solve global warming problem by dumping iron into the ocean (causing algae blooms that drop to the ocean floor)?  This article says that there is only one atom of iron per 1.6 liter of blood (clearly not counting RBCs and transferrin complexed iron), thus inhibiting growth of microbes in our blood. 

It is said that iron receptors in bacterial membranes should be a good targets to inhibit growth without promoting resistant mutants.  I don't see why the iron receptors should be refractile to functional mutations.  However, in the study, a 70 generation (20 hours?) selection of Pseudomonas for receptor mutations did not seem to enrich for any cells having alternate means to obtain iron from the environment.  Still, I am not convinced that Pseudomonas could not develop strong resistance to iron receptor inhibitors, given time. 

Iron filings in the presence of a strong magnetic field. 

March 2, 2016

Butt Implants Rising

Apparently, this procedure is really big in Brazil.

Best to get it done professionally.  There have been silicone injection parties where industrial silicone gel was injected by amateurs to give the full round look.  Accidentally injected into a blood vessel, "patients" have been killed.  More commonly there is an imbalanced look, and plenty of discomfort. 

March 1, 2016

Carotid Stents Equivalent to Endarterectomy (Reaming?)

I assume the patients with narrowed carotid arteries were randomized.  Off they go to highly skilled surgeons to perform endarterectomy or a stent expansion.  The data show each group had a 7% chance of stroke over 10 years.  What is the percent in a control group? 

I suppose the stent is placed by way of the brachial or caudial artery.  Not so invasive. 

The arterectomy may have been by reaming, but this can send particles into the brain.  The other method, I found is the eversion method where the narrowed section of artery is removed from the patient, turned inside out and scrapped, then turned inside in and reattached.  Wow, and this had the same percent strokes after 10 years.  Seems the convalescence and complications would be worse with the endo-art-ec-tomy. 

The patients had only 1% restenosis in both groups.  This is much less than the average for coronary artery restenosis (30%?). 

Then there is the fact that 90% of the treated patients were asymptomatic.  In countries with socialized medicine, they elect to have far fewer such treatments for asymptomatic carotid occlusion.  Could it be that surgeons are churning people's insurance accounts in the U.S. with little or no benefit to the patients? 

 

February 29, 2016

A New Target for Antibiotic Attack?

Well, the article does not reveal THE "mechanism by which drug-resistant bacterial cells maintain a defensive barrier."  Yes, the lipid barrier of gram negative bacteria, and almost any cell, is part of innate resistance to foreign substances (try to get an antibiotic through the thick acid fast lipid coat of a Mycobacterium). 

This has little to do with multi-drug-resistant bacteria.  Multiple resistance factors, like those often found in the gram negative Pseudomonas, are typically proteins encoded by readily transferred plasmids.  The proteins do things like bind to antibiotics or enhance their removal from the cell.  Other mechanisms of resistance can include mutations in antibiotic targets like ribosomes.   

It is nice that the beta-barrel assembly machinery (BAM) pentamers are important in insertion of other proteins into membranes.  Hopefully, molecules can be found to specifically obstruct the gram negative cell BAM.  It is not promising that similar BAMs are found in mitochondria (a side effect waiting to happen).

February 24, 2016

Lack of Coffee Causes Cirrhosis (Just Kidding)

A meta analysis has determined that there is a strong correlation between drinking of [black?] coffee and a reduced incidence of liver cirrhosis. 

I do appreciate that the authors speak of an "association" and not causation.  In fact they note that there is no proposed mechanism (mode of action; hmmm ... how about antioxidant benefits?) and the data are based on self reporting of the study participants.  It would have been nice if the studies had also included control for, e.g., self reported alcohol drinks per day. 

I was impressed that they reported "there may be an upper limit beyond which there is no further benefit".  Darn!  I was hoping that if I drank 20 cups of black coffee per day, I might actually grow a whole extra liver. 

Mormons are not supposed to drink coffee.  I wonder if they have more cirrhosis? 

February 23, 2016

Medical Technology IP Protection in Asia is Difficult, But Improving 

Asia can be a difficult place to protect intellectual property.  For example, there is typically no protection available for medical treatments or use of medical devices for treatments.  In most Asian jurisdictions, there is no grace period after offers to sell, claim scope is often limited to the embodiments described in the patent application, there are poorly defined inventiveness standards, a need to have a local presence, and spotty enforcement.   

For example, while one can patent a concept in the U.S., the issued patent claims in China are often directed to actual reduction to practice - claims focused on working examples provided in the Examples section of the application.  However, many clients continue to prosecute cases in China because they are a large and expanding market, and in the hope that the issued claims will ultimately be enforced at a scope similar to the Doctrine of Equivalents in the U.S. That is, as Chinese jurisprudence and controlling case law develop, there is hope that enforceable claim scope will be the literal claim scope plus obvious modifications, e.g., employing equivalent features with the same function in the same way for the same result. 

Arguments against obviousness rejections are fairly well developed in the U.S.  However, "inventiveness" (the rough equivalent of obviousness in Asia) can be even more arbitrary and subjective.  For example, in China "inventiveness means that, as compared with the technology existing before the date of filing, the invention has prominent substantive features and represents notable progress".  Prominent substantive notability - probably something is lost in the translation, but it gives you a clue of the flexibility Examiners have to reject claims in China. 

Overall, there is a clear trend of increased fairness in the Asian patent jurisdictions.  I believe this reflects the fact that Asia has more creativity to protect, so must provide protection to get protection (reciprocity). 

February 22, 2016

SCOTUS May Hear Case on When Generic Biologic Can Be Marketed 

I am no expert on the history or facts of this case concerning the first generic biologic drug to market at expiration of a drug patent under the Biologics Price Competition and Innovation Act (BPCIA).  It seems the policy reasons behind the law would mandate allowing the generic manufacturer to obtain a license and start marketing the drug immediately at patent expiration, unless the patent holder can show the generic product would be infringing a valid and still enforceable patent. 

The wording of the law says: 

"The subsection (k) [generic] applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)."

I do not see why this can not be interpreted to allow the generic manufacturer to give notice of intent to market the patented drug, e.g., 181 days before marketing begins, even if the drug is not yet licensed.  If the generic drug is licensed after 181 (or even 600) days, the generic manufacturer would be "marketing the biological product licensed" after the waiting period.  The licensed product would be marketed after the 180 day notice period.  If the biologic were licensed before 180 days, they would have to wait a little while to market.  (They might also have to wait to begin manufacturing, depending on the patent claims.)

With the 180 day notice (most of which would be concurrent with the final days of patent term) the manufacturer can begin marketing the licensed product.  With the 180 day notice, the patent holder has time to make a case for an injunction, if appropriate.

The statute does not seem to guarantee an injunction.  An injunction generally requires the petitioner to show facts, such as: evidence there is a substantial likelihood of success on the merits of the case.  The patent holder has to show FACTS supporting the position, e.g., that they have a valid patent that will still be enforceable against the generic drug, after the patent has expired.  This seems like a hard argument to make. 

For example, the expiration date of the patent may be incorrect, due to confusion in the context to the new America Invents Act (AIA, "first to file") law or an incorrect patient term adjustment (PTA) calculation buy the Patent Office.  These issues should be easy to resolve.  Maybe, the patent holder has another patent covering the drug, e.g., an improvement in manufacturing process or drug formulation.  In such a case, the generic manufacturer could still manufacture the old licensed drug that is going off patent.  If there is a later filed (and later expiring) patent touching on the generic drug intended for marketing, the generic manufacturer should have practiced due diligence and not attempted to manufacture before ALL valid patents to the drug are expired. 

Do not consider my comments as legal advice.  I have not watched the BPCIA cases closely and may be missing something.  Any comments from experts?

February 20, 2016

Update on Preparation of "Gasoline" From Algae

 I haven't followed the fuel from algae technology lately and didn't realize they had attained such high efficiencies in total useful solids and fuel component recoveries.

The fuel production process Scenedesmus acutus green algae biomass having 41% lipid content and 38% sugars (mostly as polymer).  See the journal paper at:

http://www.sciencedirect.com/science/article/pii/S2211926415301351

The fuel extraction process includes an acid pretreatment to hydrolyze sugars from polymers, fermentation to produce alcohol, distillation to harvest alcohol, and hexane phase extraction to harvest fatty acid lipids.  

The improvement in the article is to ferment (Saccharomyces cerevisiae) before removal of solids, thus recovering sugars that would have been lost in the solids, and avoiding the solids recovery (centrifugation or filtration) step.

Overall they claim about 88% recovery of fuel from the biomass.  This seems to be about 700 pounds of fuel (97 gallons) from a ton of biomass (which includes the water weight in the cells?).  Still, there is a way to go at $10 per gallon of fatty acid/ethanol "fuel" (which seems to require additional processing to actually be fuel for a car). 

I wonder what they can use the process waste for (potassium, phosphorous, metals, [proteins?])?  Looks like fertilizer for the next round of algae growth. 

I guess someone has long ago figured out that it does not make sense to just dry and burn the algae in a furnace to make carbon zero electricity. 

February 18, 2016

Another Study Showing No Correlation Between Cholesterol Intake and Heart Disease

Again, they say you can eat eggs without increasing your morbidity/mortality risk.  The study had a moderate number of test subjects tracked over 21 years.  However, this was not a stress test of dietary cholesterol consumption with only a half gram per day consumed on the average.  No statistical risk was detected.   

One egg a day is OK.  Moderation in all things. 

How many eggs did you eat when you were a poor collage student? 

February 17, 2016

"Not Food" Is Food To Save the World

The main concept of the inventors in the video is valid.  If we stopped raising livestock for food, many problems would be mitigated, such as clearing of forests, carbon release, and hunger generally.  To reach this goal, the Not Company makes Not Milk, Not Chocolate, and Not Mayo.  However, I'm Not Sure how this advances their stated goal.

These inventors are business people and they use all the current buzz words - non-GMO, carbon footprint, vegan, AI, local ...  But really?

They say they have a artificial intelligence (AI) software that tells them what ingredients to mix in order to obtain the taste, nutrition, appearance, rheology, and mouth feel to copy a desired animal product food.  However, this artificial intelligence must rely on data input biased by the user, and at best must rely on feedback from the users.  Hmmm, "AI".   It is not clear that the program actually learns from its experience.  

I believe a computer program with a list of potential input materials can select a recipe mimicking the molecular formula of a desired food.  But, why mimic old foods?  Further, how does this save the world?  They show seeds and beans (negative buzz words like soy and gluten being conspicuously absent), but for the AI to work well, the ingredients for recipes would employ, e.g., extracts or processed side materials from the seeds and beans.  You do not make "milk" directly from ground up beans, but semi-purified constituents.  Large bulks of side "waste" materials would result (ironically, best used as animal feed).  This process of down processing and up processing would also be expensive. 

An aspect (most important, as I used to be a process engineer) totally ignored in the article is PROCESS.  It is pretty clear that manufacture of almost all their products will require an a combination of select process steps (extraction, separation, emulsion, extrusion, blending, Maillard reaction, baking).  Many of the presented foods are puddings and cooked puddings.  Many of the foods they want to mimic are not uniform in three dimensions, e.g., having different tissues running in different directions.  They would need to intelligently blend intermediate products with different textures and molecular alignments to more closely mimic the intended animal product.

This all sounds fun to me.  But for most products, this strategy would probably not provide close substitutes for most animal product foods at a low cost (even counting "externalities"). 

I couldn't find any U.S. patents on the record, maybe explaining their failure to answer direct questions about their ingredients and recipes. 

Despite my skepticism, I wish them luck. 

February 10, 2106

Mysterious Odd RNA Splicing Variants

The closest the article gets to explaining the technology is:

"The team developed software to generate LSV maps from RNA-seq data and combine those data with existing RNA databases to yield pictures that include ordinary, known splice variants, as well as complex splice variants that other methods fail to detect.

Would have been nice if they gave a general idea on how the software identifies complex splice variants.  I assume there is a large database of common variants, and the software detects unusual sequence intersections."   

The paper is said to be published at :

http://elifesciences.org 

But, I do not see it there yet. 

Anyway, with all the talk of epigenetics, and such, this data should be important to resolving some mysteries of gene expression. 

February 9, 2016

FDA Approval of Wound Regeneration Matrix

As a child, I required an autograft to heal the worst of  bad burns on my legs.  Thankfully, I was young and had good circulation around the wounds. 

In diabetes, there is often bad circulation around foot ulcers and autografts are often not feasible.  Here, Integra uses a temporary silicone mesh support to present biopolymer (collagen, hyaluronic acid, chondroitin) particles to a freshly debrided wound.  Keep out the germs, keep things hydrated, protect against abrasion; give it time.  Hopefully, this will help some with this common problem. 

See patent at:

https://www.google.com/patents/US8357402?dq=dermal+matrix+silicone+inassignee:integra&hl=en&sa=X&ved=0ahUKEwjYlcDJiOvKAhVC9WMKHVBdCCAQ6AEIKzAC

February 8, 2016

Kill a Calorie - How is It Calculated? 

I did the bomb calorimeter experiment in high school.  When the dry food is burned in the oxygen atmosphere of the calorimeter chamber resultant heat warms water in a jacket surrounding the burning chamber.  The rise in water temperature is directly related to the amount of calories in the food.  However, the heat also includes the burning of indigestible fiber. 

I have wondered for years how this error was eliminated.  I would not have wanted to do the Atwater research - read on ... 

February 4, 2016

Chinese Patent Court Can Be Fair, Even in Process Claim Evidence Discovery

This is an update for me on Chinese patent enforcement.  There has been a difficulty in proving a case in China because there was little Discovery available, e.g., wherein a plaintiff can demand evidence from a defendant.  This has been particularly problematic with regard to methods patents, where an infringer can conceal their dirty deeds in a closed factory.

Now, I see that if the method claim is to a process that produces a New product,  there is an assumption that the process is likely the same as in the claim.  So, where the product is new and the defendant is producing an identical product, the plaintiff need only show a valid patent and that the product is identical, before the burden of proof can be reversed, requiring the defendant to show evidence (e.g., trade secret manufacturing documents?) that they are not infringing on the process.  If the defendant does not cooperate, there can be a presumption of infringement on the process claims. 

The story is more difficult, but not impossible, where the product of the patented process is not a new product.  If the suspected infringer is producing an old product, the plaintiff must show his own evidence of the process used to make the product.  This can be difficult.  However, if the plaintiff can generate enough circumstantial evidence (e.g., raw materials in, unique product properties over old process results, witnesses), the Chinese Court may reverse the burden of proof, even where the process product is an old product.  The reversed burden of proof can force the defendant to disclose their process in use. 

I like the words coming out to the Chinese opinions - balance interests, fairness.  Sounds almost like a U.S. Court, on paper.  Too bad there is not a requirement up front (with protections for trade secrets) for the defendant to disclose relevant information in the case.   

February 3, 2016

Nano-Scale, Nano Useful, for Now 

This article appears not to know that nanotechnology has great potential, but is not significantly developed or valuable, at this point.  For example, see the list of nano-accomplishments in the 4th paragraph.  Most of those commercialized examples are micro, not nano.  We are not sleeping on nanofiber bed sheets, but microfiber.   

What practical use have they been so far in biotechnology?

Not that there is no potential.  Nano tubes have great heat and electric conductivity and amazing surface area;  their tensile strength puts spiders to shame.  I have discussed nano-particles in several patent applications in the field of fuel cells.  But, nano is where   monoclonal antibodies were in the 80's - the magic bullet that couldn't fire for thirty years.

February 1, 2016

Aptamers with Increased Binding and Increased Half Life

I guess we all saw it coming.  Increased binding of aptamers using unnatural bases.  Reduced aptamer sensitivity to DNases using strong hairpins. 

However, antibodies against DNA are found in certain disease states (such as Lupus) and these molecules would seen to be antigenic.  We shall see if such modifications avoid the stated problem of "undesirable immune response" common to antibody therapeutics. 

 

January 28, 2016

Claim Structure May Help in Arguments Against Subject Matter Eligibility Rejections. 

I have found it annoying that, in the context of a section 101 ineligible subject matter rejection, the Examiner merely waves his hands and deems the other features of the claim to be not "something more" than a natural or abstract idea.  No facts, just "one of skill" would routinely do this."  The Examiner should at least have to present specific references showing the other claim features are not inventive. 

As the article says, neatly separating the possibly ineligible subject matter in the preamble may have some advantages.  Distinctly separating the  "something more" may focus the issue and facilitate structuring of arguments for inventiveness.  This can help pressure the Examiner to present actual prior art references supporting obviousness (non-inventiveness) of the features in the body of the claim.

With the inventive aspect clearly distinguished, one can then point to the fact that there are no section 103 obviousness rejections, or refer to the strong arguments against obviousness provided elsewhere in the Response, as evidence Applicants are claiming something more than the abstract/natural idea.  

January 27, 2016

CRISPR Interference is Not Only in Cells, But in Patent Court

University of California filed a CRISPR (Clustered Regularly-Interspaced Short Palindromic Repeats) method of use patent application about 7 months earlier, but MIT fast tracked their application and got a patent issuance after less than 1.5 years of prosecution (April 15, 2014).  The CRISPR technology could enable specific insertion or mutation at a gene desired sequence position.  This avoids the hazard of random insertion associated, e.g., with retrovirus gene therapy. 

But who invented use of CRISPR technologies? 

Since 2013, the U.S. has new rules of "first to file" for priority in a patent application.  However, these applications are older and will be subject to the old (Pre-America Invents Act) "first of invent" rules.  The proper patent applicant will be determined in a  battle of the notebooks to determine who invented CRISPR use methods first. 

The issued MIT patent  (U.S. 8,697,359) can be viewed at:

https://www.google.com/patents/US8697359?dq=crispr+patent+number&hl=en&sa=X&ved=0ahUKEwjp_8-Vo8DKAhUC4mMKHWbrDVoQ6AEIHTAA

The first independent claim is to methods of using guide RNA/type II Cas9 combination in a eukaryotic cell to alter gene expression.  To avoid rejection for allegedly patent ineligible subject matter (e.g., natural phenomenon) the method takes place in eukaryotic cells and the guide RNA is one not normally together with the Cas 9 (a bacterial protein).  The MIT patent appears to be also filed in Canada and Europe.

The University of California application U.S. 2014/0068797 is not issued :

https://www.google.com/patents/US20140068797?dq=Jennifer+Doudna+patent+number&hl=en&sa=X&ved=0ahUKEwjzi9D-o8DKAhUS3mMKHR2OBt0Q6AEIHTAA

The initial UC claims were to a DNA-targeting RNA comprising sequence that is complementary to a sequence in a target DNA, and a segment that interacts with a site-directed modifying polypeptide.  Original claims have been cancelled and replaced with claims that read on the issued MIT claims, for purposes of forcing the Interference process.  The UC application seems to be active in Canada, China, and Europe. 

Did MIT have the invention in their notebooks 7 months before they filed?  Did UC have the invention in their notebooks even sooner than that?  My bet is on the earlier filer. 

January 26, 2016

Bioengineering Strategies to Deal with Global Warming

This is not a bad overview of GMO benefits in light of global warming challenges.

What caught my attention was the mention of a plant anabolic pathway that greatly reduces water loss for plants growing in arid climates.  The crassulacean acid metabolism (CAM) cycle allows capture of carbon dioxide at night for processing during the day, without opening stroma in the hot sun.

See: http://cambiodesign.org/

Some of the other technologies modify expression, perhaps without introduction of dreaded "foreign" genes.

January 25, 2016

What We Will Lose with Driverless Cars

How many of these things will you miss?  How many will not really go away?

When will they make me stop driving my 45 year old Datsun 240Z?  

January 19, 2016

New Next Gen Sequencing, Easy as Threading a Needle. 

At first I imagined this was something like a Coulter counter, where cells going through an orifice between two electrode chambers create a resistance spike.  The profile of the resistance spike allowed counting of particles and even a certain amount of characterization of each cell.  I bet "they" could make a DNA sequencer that works like that.  Pull the chain through a pore and monitor an electronic signal (changed resistance between sides of the graphene, capacitance change, amphometry ...). 

But, this is different.  They create temporary chemical bonds and rely on graphene's capability to convert the mechanical strains from breaking those bonds into measurable blips in electrical current.  That is, the pores in the graphene are ringed with complementary base groups that  temporarily catch their complementary base as it comes by.  Stress on the graphene plane edge changes the conductivity of the graphene, allowing generation of a detectable signal. 

Next, they have to figure out how to stack four graphene/pore ribbons (one for each DNA base) so the DNA strand can be pulled (did you ever try to push a chain) through four pores at once to read all four bases.  

DNA reading schemes are getting more fanciful all the time.   

I can think of ways to thread the DNA into the pores.  Let's see.  There is an array of capture probes on a solid support below the graphene ribbons.  The probes have linker groups to capture a reactive group previously attached to one end of the DNA target.  The probe tips wiggle around a lot at the nano scale and soon have entered the pore from the back side.  Once they capture target DNA on the back side, the solid support and probe cannot retreat without pulling the target through the pore; sequenced as it passes through. 

Or, how about applying a charge to the capture probe and atracting it to the other side of the pore with the opposite charge on the other side ...?

I wonder how they really plan to thread the nano-needle.

January 15, 2016

"Cure for Cancer" May Be an Odd Phrase - How Many Cures are Patentable?

Another way to get as much (or more) money into the fight would be to at least partially reverse some of the Court decisions that make identification of disease processes ineligible subject matter for patenting.  Good news is, the Federal Circuit has been a little less strict in the matter, lately. 

The article said all the things I expected it to say: cancer is not one disease, there have been "wars on cancer" before, how do you define "cure", good to have more attention and funding, ...

There is hope.  Gene sequencing and epigenetics have moved along identification of factors associated with the variety of different cancers. Sequencing has also helped identify patients expected to benefit (customized medicine) from a particular therapy.  Monoclonal antibodies have come back in a big way (too bad it is difficult to get claims beyond specific CDRs). 

Janaury 12, 2016

Negative Claim Limitations Can Give Positive Results

I use negative limitations every now and then in U.S. filings, and a little bit more in U.S. claim amendments to avoid cited art.  However, some foreign jurisdictions require a positive recitation of the negative limitation in the specification (enough with the ... tion), even to support originally filed claims.  Good luck getting a negative limitation amendment in Europe. 

About half the time in the U.S., the Examiner pulls some rejection template out of the MPEP and says there is no support for my negative limitation.  I almost always win the argument because MPEP 2173.05(i) Negative Limitations and In re Johnson allows 558 F2d 1019 say - "If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims" and the "mere absence of a positive recitation is not basis for an exclusion." 

For example, if species of a claim limitation genus is listed in the original specification, or in a Markush group of a claim, individual species can be simply eliminated from the list. 

My new favorite claim - 1. All microfluidic diagnostic devices, other than those of the prior art. 

January 8, 2016

Another Example of the Fed Circuit Court Discomfort with SCOTUS 101 Holdings

Here is another example of the Federal Circuit Court judges feeling uncomfortable with the overly restrictive Supreme Court holdings regarding subject matter eligibility.

For example, Judge Linn concurred that the claims to amplifying and detecting cell-free fetal DNA ("cffDNA") in the plasma of pregnant women was ineligible under Mayo.  However, he joined the decision "only because" he was "bound by the sweeping language of the test set out in Mayo," without which he "see[s] no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible."

January 7, 2016

Case Hints Fed Circuit May Consider Some Personalized Medicine Patent Eligible

It is old news that the species teaches the genus.  Here, the genus was held to also obviously teach the species.  Another interesting aspect is that the Federal Circuit Court may consider non-obvious treatments for specific patients to be non-natural and eligible subject matter for patent protection. 

The article highlights that the Federal Circuit Court, in dicta, suggests that, e.g., methods of treatment may be patent eligible and non-obvious if the claims are directed to treatment of a particular subset of patients having a particular gene even if the treatment method was generally known in the prior art. 

 See the Decision at:

http://law.justia.com/cases/federal/appellate-courts/cafc/14-1634/14-1634-2015-11-10.html

It is nice that the Fed Circuit seems to be stretching the Supreme Court holdings on eligible subject matter.  This, after methods of determining treatment dosages were ineligible "natural phenomenon" in Mayo v. Prometheus, and identifying breast cancer mutations (subject to alternative treatments) were considered ineligible in Myriad.  

January 6, 2016

Generous Generic Drugs Off Patent Will Fair Better in the Long Run.

Can you imagine?  The worst examples of over priced drugs recently are for generic drugs, no longer enjoying patent protection.  The start up administrative and manufacturing cost barriers to entry in the market are so high that a first generic manufacturer of the drug can set the price sky high.  This, even though generic drug manufacturers do not have the costs and unpredictability of drug development, manufacturing, and three phase clinical studies experienced by the pioneering initial patent holder of the drug. 

A major barrier to entry for a second generic manufacturer is market share.  While the first into the market receives the greatest the efficiency of scale and profit margin, the second generic manufacturer into the market is a spoiler for both manufacturers. 

The present system does not seem to have been a total failure.  Generic drugs on average are significantly less expensive (half?) as when the patent was enforceable.  Those who abuse the benefits of being the first (or only) generic manufacturer can experience the wrath of the 5th branch of government (the press, don't forget the States are the 4th), or motivate the entry of a competitor, sooner or later. 

Then, there is the price of not having a patent system allowing temporary exclusive rights to pioneering discoveries.  Price of a drug that would never make it to market if there were no patent system - an average of billions of dollars and thousands of lives lost or made miserable. 

January 4, 2016

Another Zany Car Patent - Unicycle Spare Tire.

This can also work with zany airplanes and motorcycles.

Patent at:

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-adv.htm&r=10&f=G&l=50&d=PTXT&S1=(20151215.PD.+AND+ford.AANM.)&OS=isd/12/15/2015+and+aanm/ford&RS=(ISD/20151215+AND+AANM/ford)

 

December Entries:

December 22, 2015

Put Your Eligible Subject Matter Cards on the Table - Use a Defiant Claim Preamble

Mr. Hall, in the article, sets out a strategy of identifying ineligible subject matter in the claim preamble, then coming right out and saying the claimed invention is "something more".  Brilliant. 

Of course, it is more than a little annoying that the something more has to be laid out in the form of a section 102/103 (novelty/obviousness) argument in the 101 (subject matter) context. 

This strategy lays your cards on the table, and maybe raises a red flag that section 101 should be applied to the claims.  But we all know section 101 is already the darling of the year at the PTO anyway.  Examiners never miss a chance to make a 101 rejection lately, often even where the claims are non-obvious and narrow to the preferred embodiment.

December 17, 2015

R&D Becoming Cost Ineffective

The twelve listed pioneering large pharmaceutical companies are now making half the return on R&D as just a few years ago; a less than 5% return.  Is it worth the risk?  Their declining number of new drugs are experiencing half the peak sales per product.  At least the cost of terminated projects has been cut in half. 

This study has been ongoing 6 years for these relatively large pharma companies.  The trends are not good.  Small to mid-sized pharma has been doing a little better, which is one factor in large companies gobbling up small.  Small start ups are probably doing far worse. 

There is hope for "increased efficiency" and such.  But I do not see efficiency as reversing a trend of this magnitude.  Blockbusters are not in sight.  The short to mid-term savior may be in lower profit boutique (personalized medicine) drugs.  I noticed Genentech licensed two recently. 

In the long run, in order to motivate research, the world might have to pay more for drugs.  Not likely since the non-productive nations will continue to think they should get drugs without paying their share for R&D.   

See more of the study results at:

http://www2.deloitte.com/uk/en/pages/life-sciences-and-healthcare/articles/measuring-return-from-pharmaceutical-innovation.html

December 16, 2015

Devices "Configured To" Interact with Elements Outside the Claim

See December 13, blog at http://www.patentdocs.org/ .

Old news that a claim to a claim to a device configured to hold a camera does not require a camera to infringe.  Funny, I still get rejections where the Examiner ignores the "configured to" or "adapted to" language stating that it "has no patentable weight".  I guess the Examiner is misinterpreting the rule.  The requirement to act with an element outside the claim may have no patentable weight, but the requirement to have a certain capability does have patentable weight.  Still, I have trouble throwing it back in the Examiner's face because I can not find case law directly on point; only cases that do not question "configured to" language.  Anybody?

December 15, 2015

Pig Vaccination with Wild type Virus 

I guess it is a good bet to risk the healthy mother in good weather than to risk all her piglets without IgA against the virus in winter weather. 

Pretty gross, though.

December 14, 2015

ATP Fueled Biomembrane Battery Powers Integrated Circuit

After reading the Science News story, I felt like I did not actually know what was going on with this electric power source.  Apparently, powering an integrated circuit (IC) with biomembranes has not been done before due to a variety of voltage, impedance, and current mismatch issues.

In brief, the biopower source is a synthetic bilayer membrane between a couple of chambers and populated with Na/K ATPase powered ion channels.  In the presence of ATP, the ion channels pump ions and can develop a concentration gradient of Na/k ions (electrochemical membrane potential) that can be converted into an electron flow, using Ag/AgCl electrodes. See the research article here. 

Through a variety of tricks, the authors have managed to run an IC from the ATP fueled DC voltage generator.  First, they prepared a stack of two membranes series with the first feeding ions to the second, in much the same way the voltages of batteries stacked in series each add to the output voltage.  Then, the output voltage is fed into an integrated circuit "voltage doubler" to further enhance the voltage.  Then, the voltage doubler output is fed into a switched capacitor, where electrons are accumulated e.g., for more than an hour until there is enough voltage and capacity to run the CMOS [oscillator?] load for less than 100 milliseconds.  Taa daa!

Not in the news story, of interest to me, was how they convert the ion concentration differential across the membranes into electron current.  I guess they took the obvious way out, in hindsight.  The electrons come from the elemental silver of an Ag/Cl electrode.  Of course, the silver is gradually corroded away, making the electric current somewhat expensive by the amp.

The power of the biological power source could be increased greatly by increasing the membrane loading of the ion channels and by inserting them all in the proper orientation.  Apparently, the ATPase ion channel density in the power source membranes was only 5% of that found in natural nerve fibers, and much less than found in mitochondrial membranes.  My wife (a neurophysiologist) reminded me that electric eels have ion channels sooo concentrated in membranes that they are almost crystallized, and the membranes are arranged in stacks of as much as 1000 membranes to have 600 volt output.  Still hard to beat nature.

December 9, 2015

FDA Releases Environmental Assessment Supporting GMO Salmon Sales in U.S.

The salmon were found to be beneficial and of no environmental risk, to the U.S. 

A major reason the FDA was so confident the AquAdvantage salmon would not be an environmental risk to the U.S. is that it must be raised Outside of the U.S.  The FDA has no authority over what fish are grown in Panama, but assures us that it will not harm the U.S. environment to import the fish from abroad.  I believe this is true, since there are several redundant safegurads that ensure the GMO salmon can not invade natural ecosystems.   

The salmon are retained by layers of physical restraints, not least of which is the fact they are raised inland.

The greater guarantees against intrusion of the fish into the wild are biologic constraints.  The salmon are all triploid females.  This makes them all sterile and incapable of passing on their genes.  Further, the same rapid metabolism that allows them to grow faster as fry and juveniles makes them uncompetitive in nature, where there is no free lunch. 

Interestingly, the salmon do not grow to adults larger than wild type Atlantic salmon, but only they grow faster to that stage.  The FDA has deemed they safe for U.S. import and consumption.  The only problem I can see, not mentioned in the paper, is that they have three sets of genes per cell, so their meat may be less desirable to those with gout. 

December 8, 2015

Prostate Cancer Testosterone Reduction Treatment May Promote Alzheimer's  

Low levels of either testosterone (in men) or estrogen (in women), are associated with increased risk of Alzheimer's disease. 

How is it that after 70 years of testosterone reduction treatment for prostate cancer, no relative mortality data is available?  Does it have a benefit, or not?  Sheesh. 

Seems like the risk/benefit ratio for most prostate cancer treatments is not good.  Yet, many demand treatment.  Time for placebo? - with informed consent, of course. 

December 7, 2015

Incorrect Inventorship - Inequity on the Patent Office and/or Standing for Inventor to Sue

The Federal Circuit Court has held that in inventor can have standing to sue for the injury of alleged incorrect inventorship listing in an issued patent. 

The pretermitted (when was the last time I got to use that word?) inventor has a substantial damage to reputation providing standing as a plaintiff in court.  This, even though inventorship would not give the inventor an ownership interest in the patent (e.g., due to assignment of rights to the employer). 

Not mentioned in the article is the possibility of cancellation of the whole patent.  That is, intentional erroneous listing of inventors can be considered inequity on the Patent Office,  And, inequity on the Office can be a basis for cancellation of rights to all owners, innocent or not.   

Inventorship of claims is only known when allowable claims have been identified at the end of patent prosecution.  The inventors are those persons who have made an inventive contribution to any part of any issued claim.  Apparently, the parties to the suit did not dispute that Dr. Shukh was an inventor. 

When there is a dispute, an inventorship opinion may be necessary.  The claims must be construed and the contributions of those involved reviewed.  How about that ? - notebooks are still useful.  However, moments of conception still often come down to the memories of the parties, e.g., what was said at a meeting. 

Because inventors are often not the owners, inventorship listing is often not considered important at the time of allowance.  However, this case makes it clear inventorship should be reviewed at allowance in every case. 

 

November Entries:

November 30, 2015

Finger Stick Blood Samples Not Representative of Venous Blood

I was a practicing Medical Technologist for several years and collected thousands of venipuncture and finger stick blood samples.  I was always suspicious of that first drop.  We specifically did not use it for CBC (cell type differential counts) or anything having to do with platelets or coagulation.  

In this study, they considered the large venipuncture samples the standard for accurate CBC assays.  It is interesting that results apparently varied drop by drop (with no trend?) for the finger stick samples.  I wonder if the same would be true for coagulation or chemistry (e.g., glucose) assays. 

The part of the study I can not believe is they took at least 7 sample drops from the patient finger sticks without squeezing or "milking" the finger.  Really?  They must have really gouged the patient's finger with a large old fashioned lancet to get that kind of flow without any squeezing (unless the patients had coagulation issues).  Then, are such samples really representative of real world finger stick samples?

November 23, 2015

Contract Manufacturing Can be "Offer to Sell" Your Drug or Device - Federal Court Reviewing Bar to Patentability 

I always tell my clients "if you publish or offer to sell your invention, you have 12 months to file a patent application in the U.S. and have lost the right to file in most foreign jurisdictions."  I was caught by surprise 2 years ago by a case where a Hamilton Beach arranged to have a new crockpot design manufactured in China more than 12 months before filing a patent to the crock pot.  A U.S. Federal Court said the Chinese manufacturer's offer to manufacture and ship the crock pots for a price was an "offer to sell."  Because Hamilton Beach did not file a patent application in the U.S. until after 12-months from the "offer to sell" the Court says the patent is invalid because it was filed too late.  See:  http://patentlyo.com/patent/2013/08/suppliers-offer-to-make-product-invalidates-patent-under-the-on-sale-bar.html

In the field of pharmaceuticals a similar thing has happened.  See: http://www.mondaq.com/article.asp?articleid=444060&email_access=on  The Medicine's Company apparently hired a contractor to manufacture a drug and failed to file a patent on the drug in less than 12 months. Thus, the patent that ultimately issued was considered invalid due to an on sale bar to eligibility.   

The scenario is being reviewed in Federal Court to revisit the question of whether there should be a “supplier exception” to the on sale bar rule.  See: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1469.Order.11-12-2015.1.PDF

Until then, do not fall into the trap of expecting contracting manufacture of your drug or device not to be considered a "sale" or "offer to sell" your invention. 

November 19, 2015p>

GMO Salmon FDA Licensed for Production and (Ugh!) Human Consumption.

Imagine Eating a Salmon with a Growth Hormone Regulator from an "Ocean Pout" - Gross!

Those against have plenty of problems "conceivably caused".  What do you think?  U.S. States already in the salmon market are concerned about escape of the GMO salmon, and not about competition.  Apparently, the licensed GMO salmon are intended for farming inland.  They have genes that prevent fertility in the wild.  If they did escape, and successfully bread, I assume the fast growing aspect would be a disadvantage in the wild.  What do you suppose has the advantage, a fish thrown together with jacked up growth hormones, of a fish living in an environment where growth hormone levels ahve been optimized my nature for tens of millions of years?  Still, it would not hurt to start out small scale. 

I will buy the fish if it has better flavor and texture over more expensive fish.  Good that it is more efficient with feed and does not have to grown in the New Zealand or Alaskan  fjords.   Now, if I could just get over my allergies to GMO corn.  

November 13, 2015

A Shocking Way to Prevent Multi-Drug Resistant Infections on Wound Surfaces

As a child, I had burned my legs (short story - stupidity).  The great fear was infection, particularly Pseudomonas.  They used an antibiotic salve.  It was pretty unpleasant when they tried to remove the bandages (glued on with my body fluids), but I did not get an infection. 

Anyway, there were not so many antibiotic resistant bugs back then ('70s).  Good they have a option for wound surfaces that does not depend on antibiotics alone. 

November 12, 2015

Biotech Patenting Problems at EPO, but Filing Up 

In many ways, the rules are similar to patent eligibility rules in the U.S.  For example, Product by Process claims are allowed if it is the only way to describe the product.  (Good luck actually getting the claims to issue.)

It seems strange that only "usual" meanings are allowed to describe cutting edge technologies at the EPO.   In the U.S., the Applicant can be his own lexicographer.  That is, we can make up our own terms, as long as the term does not conflict with a usual usage.  We can use an unusual word.  If we have a pioneering invention, we can make up our own word. 

No plants or animals, no unusual words, no product by process.  "No, no, no, "bad children; play nice."  And yet, biotech is up in Europe.  Now if we can get them to eat "Frankenfish".

November 11, 2015

Interesting Article on Next Gen Sequencing Pitfalls

What a lot of trade offs.  There is a need to use plenty of controls and employ the technique best suited to your samples and goals.  For example, though PCR can cause certain artifacts, it also enhances sensitivity.  Some next gen sequencing (e.g., Illumina DNA colony technique) techniques inherently amplify.  For others, it has been suggested that sensitivity can be enhanced with less artifacts, using a lower cycle PCR.

November 5, 2015

Can a Drug Product Insert Result in Infringement of a Patent Method Claim?

What a path to the deep and unsympathetic pockets.  Let's see, the doctor is said to directly infringe the method, even though he/she never actually practiced any of the method claim steps.  Then, to get big pharma's pockets, the manufacturer is said to indirectly infringe by providing a product insert with instructions on how to combine the folic acid, methylmalonic acid lowering agent (e.g., B12) followed by administering an effective amount of pemetrexed. 

"Because the defendants' proposed generic drug-labeling instructs physicians to follow the patented administration, the court found they would be liable for inducing the physicians' infringement."  In order to avoid suing the patient or doctor, the patent holder sued the generic drug maker based on the maker's product insert instructing another to practice the claimed method of administering the drug.  Best to sue the deep pockets of evil pharma, and stay away from the bad PR of suing doctors and patients.  

Actually is seems that at most that providing the product insert was at most indirect infringement (knowing end users would infringe the patented method).  And the doctor may also have indirectly infringed, because she probably never actually practiced any of the method steps.  Finally a nurse or the patient may have directly practiced the method (or even each contributed a step, so no one directly practiced the method). 

Wow.  I believe this is actually a case of inducement to induce to directly (or contributorily) infringe.  Sounds like a hard case to make, but not so hard if there are deep pockets at one end of the chain. 

Find the drug administration patent at:

https://www.google.com/patents/US7772209?dq=7,772,209&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMI5oToypT3yAIVVN5jCh37VA18

I expect that the Court had a "gut feeling" (in equity) that the drug company was the main culprit benefiting, so went out of their way to construct a colorable theory of guilt. 

November 4, 2015

Malicious Filing of Patent Application to Gain a "Monopoly" - Don't Trust This. 

What I find astounding is that an eddy current braking system would be considered novel, much less non-obvious.  The only new thing about the brake system on an amusement park ride, is that it was on an amusement park ride.

See the 6,062,350 patent at:

https://www.google.com/patents/US6062350?dq=6,062,350&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMI3cawrf71yAIVQs9jCh0juAHI

That aside, the article is annoyingly vague about the date of conception (1994), offer to sell (1995) and patent filing date (1996).  I assume the Plaintiff did not have these facts, and failed to obtain them in discovery.  Without, there was no case.  Too bad for the Plaintiff.  If Intamin, the ride designer, offered the brake system as claimed more than a year before filing the patent, the patent is invalid for lack of novelty.   

This is a new one for me.  Sherman Anti-Trust for alleged intentional filing of an invalid patent.  Step one should have been presentation of what Intamin knew and when they knew it.  See the Court case at:  http://cdn.ca9.uscourts.gov/datastore/opinions/2015/09/14/13-56119.pdf 

Basic lesson - don't make conclusory allegations you can not back up. 

November 3, 2015

OMG Human DNA in Food Prepared by "People"

You know the Clear Food co-founder is being disingenuous from the following:

Journalist - "Wouldn’t a dish I made with my bare hands be likely to contain human DNA?

Ghorashi disagreed with my supposition that handmade food would necessarily contain human DNA and said that they were just trying to be objective."

Ghorashi knows the extremely sensitive DNA assays WOULD likely show human DNA in hand prepared food, but I believe he avoided the admission because it goes against his business model. 

Too bad the article makes no effort to describe the DNA detection technologies involved.  Even the Clear Labs web page seems to only refer to "third party testing". 

November 2, 2015

Wither Indian Plants?

India has often railed about westerners stealing their plant medicine heritage (which Western rules for patentability (e.g., no natural compositions) do not allow). So, I expected this article to be about leafy plants.   We all have our narrow perspectives on life.

I used to design and scale up GMP drug manufacturing in the U.S., so I know a think about GMP manufacturing. 

I have also spent a lot of time over the years in India.  Years ago, it would have been impossible to do GMP manufacturing in India at the standards required in the U.S.  I suppose it is possible now.  At least the utilities (e.g., electricity) are a lot more reliable now.  Still, there are physical, infrastructural, and cultural challenges in India that would require very high levels of oversight in order to avoid GMP violations in India. 

One can save money on labor in India, but the savings can be at least partly lost in extra efforts required to maintain quality. 

October Entries:

October 30, 2015

Fun Article that Makes You Think About Patent/TS/TM Strategies

For many consumer products, the Silly String hypothesis is worth testing.

October 29, 2015

Using Facts to Argue Against Claim Rejections

More advice on how to get past section 101 subject matter ineligibility rejections. 

I think the author is right about the Examiner's "comfort zone", but it has not been my experience that it revolves around case law. 

Rejections for whatever reason (101, novelty, obviousness, ...) are all about the Examiner's comfort zone and her need to have something on the record justifying withdrawal of a rejection.  If an Examiner has a gut feeling there may be obviousness, they often do not have time to dig up the facts and use logic, so they make conclusory statements and put the burden on the Applicant to present facts on the record against the rejection.  Facts on the record can make the Examiner more comfortable, e.g., with presenting an allowance to their supervisor.  (Funny, they do not seem to be embarrassed by their initial lame rejection.)

Another source of "comfort" in subject matter eligibility is definitely the scope of the claim.  If the Examiner can get you to add a limitation focusing on your intended narrow market segment, that can lower the pressure.  Narrower claims have a lower profile and this provides comfort.  Claims focused on a particular device or method provide a fact pattern for allowance in alignment with the PTO Guidelines and MPEP.

I like the statement in the article that "[f]actual findings supporting arguments that the claims are to patentable subject matter should outweigh unfounded assertions that they are not."  The Guidelines ( http://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf ) list factors the Examiner should weigh to determine if the balance is for or against patent eligibility.  There is no bright line here.  But ... where the Examiner has not provided any facts, your use of facts can "persuade" the Examiner to drop the rejection. 

I do differ with the author's position that facts to Case Law makes Examiners comfortable.  I find Examiners focus on the MPEP and the little snippets of case law they find there.  Key words in the snippets are often twisted by the Examiner to support rejection when the case law actually holds for the opposite.  It is not unusual for Applicant's facts not to persuade the Examiner over their lack of facts applied to case law.  However, the fall back position is that some supervisors, and the Appeal Board members, do understand case law holdings, and application of facts. 

October 28, 2015

More Details on the Google Books Case

Here is a more detailed analysis of the Google Books case. 

The policy reason for copyright is ti avail the public of creative works.  Most of the works searchable through Google books are out of print or forgotten.  The ability to search them can bring them back to life in the public eye.

Meanwhile the snippets available from the search are not a substitute for the full work and are only available in a transformed embodiment.

Further, I assume Google is not going to make back its expenses any time soon on this adventure.  We all know how altruistic Google is. 

October 26, 2015

Things to Avoid When Trying to Patent Methods of Treatment

Oh, boy.  Methods of treatment.  So many issues. 

Many countries exclude methods of treatment from patent eligibility.  They believe it is unethical to restrict treatment of a patient.  They probably have a point.  However, this must be balanced against the lost benefits.  (They don't notice the unknown patients that did not get treated because no one was motivated to invent the treatment -  and no one notices something that does not happen.)  However, in some of these countries, you can still claim the method of treatment using "Swiss style" claiming, e.g.,  the use of a substance for the manufacture of a medicament for treating disease X, even where the substance was previously known. 

Then, there are the section 101 patent eligibility issues in the U.S., wherein the response of the body to the treatment may be considered a patent ineligible "natural phenomenon".  How can we forget Mayo v. Prometheus (  http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf ) where monitoring the metabolites of an Unnatural drug in a patient to adjust dosage was held ineligible by the (somewhat ignorant) Supreme Court as an ineligible natural phenomenon:

Mayo claimed - A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered ... 

Note the two steps.  Even if the Mayo claim were valid, one (two?) could avoid infringement by having the administering step done by a first person and the determining step by another person. 

The article gives good advice on how to draft method claims to include only one actor.  For customized treatments, the use of a past tense step seems like a good idea.  For example, treating the patient for a indication (disease)  "previously determined", where it is immaterial who did the determining (identifying, assaying) step.    

I like the back-up advice on using the doctrine of claim differentiation to confirm that a broad treatment claim does not require a determining step.  The doctrine of claim differentiation creates a presumption that each claim of a patent has different scope.  So, the article presents the great idea of including dependent claims wherein the parent genus claim "further comprises" the determining step.  Logically, if the broad parent claim already included a determining step, then there would be no need for the claim "further comprising" a determining step.  The presence of the dependent claim further comprising the determining step gives the Patent Attorney strong evidence against the Patent Examiner (or infringer) interpreting the broad parent claim to require a determining step.  Simple!

Now, for my best advice.  Do not write the claim that makes the ill patient the infringer.   Let's see, don't write: "the steps of having your blood tested and receiving a treatment".  You don't want to be the bad guy making the evening news for suing a sick person.  

October 22, 2015

Algae Virus Invades Human Cell 

My first thought is - how do these viruses cross both mammal cell membranes and algae cell walls?  I suppose the mammal cells engulf them. 

The Chlorella viruses are large and have many unusual properties, including ion channels and endonucelases.  See, e.g., http://www.ncbi.nlm.nih.gov/pubmed/16877063 .

I will have to be careful next time I clean out my pond.

October 21, 2015

Men Demand Libido Equality!

I want a drug that improves my sense of humor. 

By the way, Viagra does NOT improve a man's sexual desire.  It treats erectile dysfunction.  So, to be fair, and to keep men from "being left out of the [Addyi] revolution", we demand a drug that has barely any efficacy and lots of side effects too!

October 20, 2015

Good Review of Design Patent Prosecution Compared to Utility Patents

This is a good focused primer on Design patent prosecution issues and concerns. 

As with Utility patents, the claims are the intellectual property.  The claims must be supported by the original description and FIGURES. 

The Figures must be totally accurate and use lines according to special Design patent rules. 

Check out this good review.

October 19, 2015

Fed Court Holds Google Scanned Book Search Not Copyright Infringement.

Not much content here, but big news in copyright. 

I believe Google is not intending to present full text (but for ancient texts) as search results.  Might even help sales of books easier to identify.  And should make available searches to out of print volumes.

October 18, 2015

What is New Under the Sun in Microfluidics?

The article is directed to the credibility of a diagnostic device company.  This should not be an issue, because the data should tell the story, not hype, emotions, or product marketing puffery. 

I snooped around a little, but didn't find much remarkable in the Theranos patent applications.  Maybe they still have some unpublished applications, but breakthroughs forming the basis of a company usually come out early. 

The first (Canadian) Theranos patent application I found is not issued and I believe has excessively broad scope claims, making it probably not novel. 

https://www.google.com/patents/CA2896407A1?cl=en&dq=inassignee:Theranos&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMIxcKqxIzGyAIVF0uICh2p5gJY

The second application I found may have a new combination of several routine assay device elements, but would probably have a hard time arguing against the inevitable obviousness rejections. 

Microfluidics is an old and crowded field.  I could not readily identify some breakthrough technology (some amazing cornel of inspiration - no polymerase chain reaction here)  in patents that makes would give Theranos a significant advantage in the field.  They may have trade secrets, but these are hard to protect in device technologies.  Does anyone know of anything special about Theranos? 

In any case, validation of device parameters is routine.  What are the sensitivity, precision, accuracy, repeatability, ruggedness, etc. of these assays.  If they have something special, they should spit out the numbers?

"Cheaper, faster, and more efficient blood testing technology" compared to what?  Let's see the comparison data  - the numbers.  The facts (they must have in hand) could lay to rest any controversy about how special they are.  Sorry, just my process and assay validation background coming through. 

October 17, 2015

What is the Magic New Model to Lower Drug Prices?

Drug pricing outliers are in the news lately.  You know, the expensive (but cost effective) drug against HepC, and the no competition price rise by the young hustler CEO for the generic against parasite infestations, e.g., in AIDS patients.

The article mentions that (god forbid) pharmaceutical companies have the same profit margin as (evil) banks!  I bet the data do not take into account all the small (and medium) start ups that that lose millions for years, more likely than not to go our of business, or  get bought up for less than their accumulated losses.  That is, the overall profit margin for all pharma (including those that never make it to a licensed product) is probably lower than for banks.  And, the hope of profit (and good deeds; really) is what starts all those small drug companies that have been the main pipeline.  This does not come free, and someone has to ultimately pay for this risk. 

So, what is the better model, e.g., better than the extremely successful model in the free world (how many new drugs did the Soviet Union develop?) suggest by the article?  They discuss the model at https://www.chathamhouse.org/publication/towards-new-global-business-model-antibiotics-delinking-revenues-sales

To me subsidies for antibiotic development looks like a well worn model that works in certain circumstances.  For example, this is similar to government subsidies for orphan drugs.  Nothing wrong with that, in its place.  But, it is not a general solution to high drug prices. 

October 16, 2015

Satellite Patent Office Opens Today in San Jose

I hope they have Examiners in the main fields I work in.  I am good on the phone, but you can not beat face to face.  There are a lot of biotech and high tech inventions coming out of the Bay Area.  

October 15, 2015

Surprise Me! - You Can't Avoid Infringement By Imagining Additional Limitations to the Issued Claims

Boy, this is old news.  Seems to be a story of a defendant trying to make unreasonable new laws to exculpate themselves from clear guilt. 

Apparently, the infringer chose to practice a less preferred embodiment of the invention (severable strip releasable along one score line instead of the preferred two). 

To get out of the infringement accusation, the defendant suggested claim construction based on limiting the claim severable strip element to the preferred two score line embodiment.

Now, wait a minute!  What did the claim say?  See U.S. 7,118,003 - https://www.google.com/patents/US7118003?dq=7,118,003&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMIvP3uip3ByAIVVtNjCh1CZQWl

Claim 1. A tamper-resistant/evident container comprising:

a) a plastic, transparent cover portion including an outwardly extending peripheral flange;

b) a base portion including an upper peripheral edge forming at least in part an upwardly projecting bead extending substantially about the perimeter of the base portion and configured to render the outwardly extending flange of the cover portion relatively inaccessible when the container is closed; and

c) a tamper evident bridge ["scores" are not even mentioned] connecting the cover portion to the base portion.

The claim does not even touch on the aspect of score lines.  Straw man argument.  "I am not guilty because the claims are to red apples and my red apples also have a sticker on them.  Therefore I am not infringing." 

Further, "claim differentiation" requires that, e.g., if a dependent claim limits an element to one of two possible options, then the parent claim must have included additional options.  Thus, the dependent claim is differentiated from the parent and of narrower scope. 

Dependent Claim 4. A tamper-resistant/evident container as recited in claim 2, wherein the frangible section of the [tamper evident bridge] hinge is delimited at least in part by a pair of parallel score lines.

That is, if claim 4 further limits, claim 1, then claim 1 must include the recited parallel score lines, and at least other alternatives (e.g., a single score line) listed in the original application.   

Anyway, it is old law that the claims as issued define the intellectual property.  The claims properly construed reflect admissions and compromises in the prosecution history (file wrapper).  However, The claims are not limited in scope to preferred aspects the infringer chooses to thrust into the claims.  Otherwise we [not me, but maybe you] could all run around infringing on patents and (when caught) just say" the claims are limited to aspects I are not practicing.  I win!"

October 13, 2015

What Aspects of Your Medical Device and Methods are Eligible for Patent Protection?

Here is a good example of what is patent eligible and not in a diagnostic device.   

The following claim was found ineligible in Federal Court under 35 section 101 (https://www.law.cornell.edu/uscode/text/35/101) of the patent code for allegedly being merely the application of a Law of Nature using well-understood, routine, or conventional step:

Claim 51 - A method of detecting human body temperature comprising: measuring temperature of a region of skin of the forehead; and processing the measured temperature to provide a body temperature approximation based on heat flow from an internal body temperature to ambient temperature.

The claim was written in a patent application before certain Supreme Court rulings that made patent subject matter eligibility more restrictive.  After that, the USPTO provided Examiners with Guidelines (http://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf  ) with factors to consider in determining, e.g., whether the claim adds "something more" (inventive concept) to the ineligible natural phenomenon.

What the article does not mention is that many other method and device claims in the patent (U.S. 7,787,938 - https://www.google.com/patents/US7787938?dq=7,787,938&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMIsPSxu9m1yAIVBJeICh3IEAdP) were not held to be invalid for ineligibility.  For example, see claim 14:

Claim 14 - A method of detecting human body temperature comprising making at least three radiation readings per second while moving a radiation detector to scan across a region of skin over an artery to electronically determine a body temperature approximation, distinct from skin surface temperature.

So, include specific devices and method steps in the claims (narrowing focus on your particular invention, not monopolizing the natural phenomenon) to make them patent eligible. 

October 12, 2015

Apple Rivaling Tesla in E-Car Technology - Stealing Employees

I like driving my 43 year old car (240Z), shifting, and looking out the window (though I did install a moving map).  And, I do like looking out the window when I drive (though I am studying instrument flight of airplanes for a certificate, so I don't have to look out the window.  Hmm.)

Anyway, the iCar may be streamlined, but seems to be essentially a delivery device (See:

http://www.nbcnews.com/tech/tech-news/apple-graveyard-failed-tesla-employees-elon-musk-n441616). 

The special thing about humans is their ability to process information.  It seems in the not too distant future, we will not be needed for that anymore.  Great.  Then, we can all just go dream in sensory depravation chambers like that Apple car. 

October 6, 2015

You can Still Get a Nobel Prize (But Maybe Not a Patent?) for Nature-Based Medicines

Avermectin is apparently a macrocyclic lactone antiparasitic agent from a family of compounds first identified in Streptomyces sps.  At first it was found to have antihelmenthic properties, bringing some aid to the hundreds of millions infested with parasitic worms in any part of the body.  We in the West are more familiar with avermectin for its use in pet flea medicines due to its insecticidal properties. 

Apparently avermectin has such a broad range because it blocks nerve activity in invertebrates generally.  Avermectin apparently opens up glutamate channels allowing hyperpolarization by influx of chloride ions into the neurons.

A quick look for related patents finds though the avermectin may be a unique compound (modified by man?), the patents mostly concern methods of administration (to avoid rejection as ineligible natural subject matter).  See, e.g.:    https://www.google.com/patents/US20100087492?dq=parasite+ininventor:William+ininventor:Campbell&cl=en

October 5, 2015

Pacific Rim Trade Deal Short on Biologic Drug Protection

U.S. negotiated for 12 years exclusivity, AU and NZ wanted 5 years, deal is 3 Years? 

We will see how this plays out in Congress.

October 3, 2015

Playing the Logical Song with Examiners

I often use logic (or more often illogic of a rejection) to successfully argue against rejections in claims.

It is quite common for Examiner to frame rejections in the language of logic - "since the prior art teaches this ... therefore the one of skill would be motivated to combine the references."  Take these statements apart and they often are devoid of facts supporting the conclusion, or the conclusion does not follow the premise.  I actually bought a collage logic text the brush up, and it has helped. 

The most common error in logic of rejections is conclusory statements - "because the claims are obvious, they are obvious."  I note the Examiner has presented no facts.  Then, I systematically present application of facts that objectively prove the Examiner is wrong.  Sometimes the facts have to be applied to the corresponding facts found in a holding of controlling case law and things can get a little more subjective.

After a good logical argument against a bad rejection, the Examiner will often just ignore the strong points and attack minor side arguments.  Alternatively, the Examiner often presents a "straw man" (false premise) argument where he forcefully argues against an intentionally or ignorantly misinterpreted version of your argument against rejection.  That is, arguing against a weakened of different version of the argument you presented.  The best way around these continued rejections bring the error to light in an Examiner Interview and force the Examiner to present a logical counter argument (sometimes I find I was the one who was wrong!).  Eventually, logical arguments can be the most successful on Appeal. 

October 2, 2015

HERV-K "Virus" Escapes Human Genome and Causes ALS, Etc. 

Does anyone know more about this?

The article suggests that the virus is propagating, but I suspect the "virus" is a transposon. 

I imagine many archaic viruses hidden in our genome are causing any number of disease states ... and providing sequences useful in our day to day lives. 

 

September 30, 2015

Vermont Can Tread On GMOs But Not On Nature

Vermont passed laws intended to control the use of the phrase "natural" in food products and requiring conspicuous labeling of "genetic engineered" products. 

I am inclined to favor full disclosure in most cases.  But, for some reason, I find the GMO product labeling rules annoying.  This is probably mostly because I worked so long in the biotech industry and can not envision a mode of action for a toxicity caused by the specific modified proteins in food products.  I am confident that GMO products are a net benefit and ignorant people will be hurt by the rule the labeling rules.  For example, when I was growing up, we were poor.  I was always excited to see a new gallon of milk in the refrigerator.  It really bugs me to see a gallon of milk going for $8 because the dairy cows were not fed GMO corn.  How many mommies think they are raising healthy kids, but are actually cheating them of nutrition for no material reason.

Another thing I find annoying is that certain people have their minds made up (like those arguing against global warming) that all GMOs must be bad.  No amount of studies can persuade them otherwise.  They just keep on the drum beat of "we need more studies" - until there is proof of a negative, e.g., that GMO corn is not going to give you cancer. 

I have to believe that in the long run, GMO will win in the market.  Quality products at a good price should ultimately win the day.  Already GMO haters are failing to refuse the genetically modified medicines that are already saving lives every day. 

Anyway, apparently Vermont can not control the use of the word "natural", mostly because they did a bad job of writing the law.  What is with that uncertain phrase - all natural or "any words of similar import"?  Laws that do not give clear notice to the citizens should not be enforceable.  I guess there is no ambiguity in the terms "genetically engineered."

Ironic that, in patenting, some genetically engineered inventions are not considered eligible for patent protection because their DNA or protein sequences are too "natural"!

September 28, 2015

Layered Defense to Prevent Infection of Implant Surfaces

It looks like these films on the prosthetic surfaces don't last forever, but long enough for a convalescence.

For example, a hip replacement outer surface can have a non-antigenic polymer, then a antibacterial peptide, followed by our old friend nano-silver.   Follow that with a an extremely fine polish to remove opportunities for microbes to loiter.

Maybe, then, antibiotics could be held in reserve.

September 27, 2015

Investigations into Permanent Contraceptive Device  

When the alleged complications present as such a diverse array, it is likely that many of them are not actually caused by the medical device, though one or more may. 

They should take complaints seriously and look into any possible problems.  If there is actually a problem caused in some women, how would you identify it against the background?  If they are lucky, they might find a clear cut case and at least have a model and mechanism to identify countra indications. 

September 26, 2015

Experts Review the Effects of Patent Eligibility Restrictions on Inventions in Biology

Experts agree these are relatively difficult times for diagnostics, software, and biomolecule patents.   

Patent eligibility (35 § 101) depends on factors, such as whether there is a physical device involved in the claimed invention, a physical transformation, and/or a narrow focus (thus not monopolizing a natural phenomenon).

It is often easier to avoid these eligibility issues with carefully crafted claims and supporting application.  See factors weighing in favor of eligibility in the current Patent Office Guidelines - http://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf .  The problems are more difficult with patent applications drafted before the new restrictions of recent Supreme Court holdings.

These new restrictions will reduce innovation in medical diagnostics, analyses, and medical devices.  Hopefully, the pendulum will swing back a little when the politicians realize the current policies are counter productive. 

September 25, 2015

Tiffany Trademark Not Generic Just Because Tiffany Style Setting is Generic to Jewelers

Jewelers know a Tiffany setting as a generic type of setting.  However, the term is probably not generic within the buying public, as a whole. 

Costco may have done better if they had called it a "Tiffany style setting", to minimize confusion.

September 24, 2015

Patent Law Damages a Good Basis for Reasonable RAND Rate

However, Fed 9th Circuit still requires totality of circumstances approach to determining reasonable and nondiscriminatory (RAND) rates in agreements and damages for pooled use of standard essential patents. 

September 21, 2015

Male/Female Fetal Risk Varies Through the Trimesters (and Beyond) 

I always figured there was a bias toward males at conception, e.g., to make up for the higher male mortality during infancy (and beyond). 

Here they have identified several phases of gestation where the greater risk of prepartum death alternates between male and female. 

September 18, 2015

Happy Birthday to You - Again.

Here is a little more information on the dramatic story of the Happy Birthday song. 

It would be nice if it were to finally enter the public domain.  I can hardly take it when the staff at a restaurant has to come up with some alternate rousing Birthday song when they give away a birthday muffin with a candle in it to someone who "says" it is his birthday. 

Still, the original Happy Birthday to You is not free of its own problems.  If only people could hit the high note. 

September 16, 2015

Miraculous High Tech Medical Devices Reduce Malaria Deaths 60%

What Can I say?

I wonder how many of the billion mosquito nets were paid for by Bill Gates?

September 15, 2015

New Perspectives from Hallucinogen Treat Opiate Addiction 

The new perspectives of a hallucinogenic Ibogaine plant extracts can reset the priorities in life for opioid drug addicts.

Besides the mental attitude change, an unexplained (and unrelated?) phenomenon is the drug actually limits physical withdrawal symptoms. 

Hmmm.  Both these benefits from one drug.  Maybe the extracts are complex and there are several plant compounds providing the multiple effects.

Wow. 

September 14, 2015

Unproven Concepts in Public FDA Licensing Documents Do Not Render Drugs/Devices Unpatentable

This is good news for bio/device companies trying to FDA license and patent their inventions.

It appears that in order to manufacture a patented drug, a potential infringer filed a challenge (IPR - inter partes review) at the U.S. Patent Office alleging that the claimed drug was not new.  The basis of the challenge was that a preliminary generic study and Phase II proposal allegedly published the invention (dimethyl fumarate for use against MS), rendering the method not novel (and not patentable).  The actual results of FDA studies were not published before filing of the patent application. 

It is nice that the Patent Review Board (PTAB) found that the publicly available information cited by the challenger did not actually anticipate the claimed invention.  This is a little more generous than many patent Examiners who would have deemed the invention as "obvious to try" in light of the suggestions in the cited publications.  Of course, the argument against such an obviousness rejection would be that "obvious to try" requires facts showing that at the time of the invention, there had been a recognized problem or need in the art with a finite number of identified, predictable potential solutions.  See, MPEP 2143.  Although MS was known as a problem and maybe suggested as a possible treatment, use of DMF in treatment was not predictably efficacious.  Anyway, the PTAB is generally less biased toward rejection than the average Patent Examiner. 

Another reason the PTAB  held the claims to be novel is probably political.  Think how many past and future licensed drugs and devices could be deemed unpatentable for lack of novelty if preliminary proposals (a wish and hope), e.g., in public licensing submissions, were deemed to anticipate inventions not yet confirmed by reduction to practice.  For these policy reasons, this case may be going against the general situation that actual physical reduction to practice is not required to support a claim in a patent application or in a cited reference to render the claim old or obvious.  That's one less blow against the protection of intellectual property in the drug and device industries.  

September 11, 2015

Patent Fun - Stacked Wings on Aerocars (Idea Stolen From Red Baron)

They left more out than just the propulsion configuration.  The aerocar might obtain adequate lift, with at least 5 operating wings, but there would be a lot of drag and so much vertical stabilization that it might be hard to turn.  Most aircraft rely on ailerons out at the wing tips with a lot of leverage to turn the craft by rolling.  Here there is no leverage and a lot of forces working against roll.  So much turbulence behind the wings that that elevators and rudder would not work.  Seems all you get is lift and no control.  (Sorry about my private pilot cynicism.) 

Still, this design does address the most perplexing problem with flying cars - how to reduce their width after they land.

Maybe this could be used by Amazon as a way to deliver cars.

Try, if blocked:  http://blog.caranddriver.com/toyota-two-inventors-file-patent-for-aerocar-with-dynamic-stackable-wing-system/

September 9, 2015

Enhanced PK in Deuterated Drugs

The bonds deuterium forms with carbon atoms are stronger than those formed between carbon and normal hydrogen.  Who knew?  Apparently this was well known since the '70s.  So, for some drugs with pharmacokinetics heavily influenced by degradation at the bond, PK can be improved by deuterating key H-C bonds.  I guess this may help in 15% of cases.  This shouldn't cause an activity problem except, e.g., the unusual case where activity depends on proton donation.  

Here is another example of where maturation of a technology will eventually render similar products obvious and unpatentable.  Like the stereo isomers example. 

In another aspect, it is sorry that donation of an idea to the public domain (e.g., expiration of a patent) actually leads to disuse of the idea because a successful new application of the idea can not be monopolized.  I know ... maybe I should patent tritiated drugs?

September 8, 2015

No Need to "Defang" CRISPR for Use in Specific Gene Regulation

Here is a finding that mere use of a shortened guide RNA can allow Cas9 to bind a specific target sequence but prevent the cleavage. 

Apparently, cas9 can be fused to a controllable protein to turn a target gene off and on (not sure how the Cas9/coltroller structures interact for this function).  Anyway, a cool new aspect of the ability of the CRISPR/Cas systems to target specific sequences in living eukaryotic cells. 

September 7, 2015

In Europe, Can a Priority Application Anticipate a Claim, While the Same Priority Application Can Not Support Filing of the Same Claim?

No wonder I have had trouble clarifying the issues of novelty over parent applications, partial priority(?), and toxic divisionals in Europe (EPO).  Apparently, the Europeans still have not figured it out themselves.

I will have to ask my EP Attorney about this OR wait for the 2016 decision in the discussed case.

Am I missing something here, or "isn't it ironic?" that the EPO will NOT find support for claims in a parent priority document for a filed or amended claim, yet finds the same parent document IS toxic prior art over the divisional?  Hmmm, the parent does not describe the claims, yet renders them not new.   

Isn't the EPO over the top in finding novelty destruction in the context of claim rejections, while the same support is inadequate in the context of claim amendments during prosecution?  I am not an EPO attorney; just trying to understand the logic or politics for these EPO policies. 

September 3, 2015

Problem with Implanted Artery Clot Filters

I have worked on a few stents, but I have never even heard of this device.  Do they permanently implant them in 45 year old women?  Coated titanium, I guess?

Gosh.  If a clot can push a filter clear into the heart wouldn't there have been a catastrophic myocardial infarction in any case?

Game theory.  At what point do you recall a device on hearing of problems?  Don't all devices have some problems?

September 1, 2015

"Means" Language Makes a Computer Algorithm Inventive and Patent Eligible

The method is an algorithm, but the Court was unwilling to go to that 101 issue for failure of IPR challenger's conclusory arguments.  The 101 subject matter eligibility analysis continued to step 2 where the general purpose computer issue was reviewed. 

Ultimately, the means plus function claim element generated, in effect, a “special purpose computer” providing a meaningful limitation on the claimed abstract idea.  The key aspect saving eligibility here appears to have been the "means plus function" language.  Hmmm.  The narrow means may have rendered the invention patent eligible because it was considered inventive (non-obvious in light of cited art). 

Warning: Now I Am Being Kind Of Funny (too many readers take me serious at all times) -  From now on, I am going to use means plus function claims.  How about, "a special purpose nucleic acid means" adapted to hybridize to a natural sequence correlated to a disease state."?

August Entries:

August 31, 2015

Nano-Technology Still Seems to Have Nono-Utility in Medical Devices

Many nano-device concepts seem a little unrealistic, like the predictions of the future at the 1939 World's Fair.  Several seem to describe nano-scale structures in the wrong context.  For example, descriptions of nano-scale devices as if there were gravity and frictional interactions, which often diminish to irrelevance as nano-scales are approached. 

The only place we seem to have a realistic and short term promise for nano-technology in medical devices is fibers and fabrics.  And here, their structures do seem to function in ways similar to analogous macro-fibers and biomolecules, e.g., transmitting tension forces along a line. 

Factories, robots, welders, and walkers.   I guess nanotechnology is so new we have to use macro-scale terminology to help describe imagined analogous phenomena. 

If the promise of nanotechnology seems a little over stretched for now, it also seems the dangers are a bit overblown, given current information.  As noted in the article, we can only hope the promises will be fulfilled without irrational fears that have nearly stifled GMO technologies in some circumstances. 

August 30, 2015

Don't Cite "Probably" Prior Art. 

Next time I get a flaky "prior art reference" from a the Patent Office in a section 102/103 rejection, I am going to demand the Examiner provide evidence that the material was published specifically to "those in the art" and demand an exact publication day (e.g., for web references or nucleic acid sequences). 

Oh yeah, do not use  © (circa/about) for a critical reference citation in an adversarial proceeding.

August 25, 2015

You Don't Have to Be a Glutton to Like Gluten

My favorite bread flour is "high gluten" flour.  You get a nice crispy tasty crust. 

I know several people who actually have a severe problem with the real gluten sensitivity of celiac disease.  We have special recipes for baked goods we bring when visiting them. 

Still, there has been some hysterical anti-gluten media reports that have caused a reverse placebo effect in society.  It is crazy.  Do you want your bananas and fish to be gluten free?  Then, we can sell you some, for a slight premium. 

It is easy to place blame in error for an illness (just look at the whole vaccine debacle).  Whatever you were doing at the time of the symptom must be the cause (hind sight, anecdotal evidence). 

I remember I was eating Chex Mix as a child when I came down with the measles.  For about 10 years I could not eat Chex Mix (or even look at it); even though Chex Mix did not cause my measles.  Imagine how such errors can be catalyzed by relentless negative media accusations (and marketing promotions).    

August 24, 2015

Apple Screen Surface Design Patent Invalid for Obviousness

These Apple design patents have been annoying me for years.  Design patents are supposed to protect an Ornamental Non-Functional aspect of a product.  It was crazy that Samsung had to pay Apple hundreds of millions of dollars over the highly functional aspect of "rounded corners" (do you want sharp corners in your pocket phone?) design patent.  See: http://www.google.com/patents/USD670286?dq=D670,286&hl=en&sa=X&ei=zgWdUNGqIIHo0QGsz4HQDQ&sqi=2&pjf=1&ved=0CDQQ6AEwAA

Now, at least one of the three Apple design patents has been invalidated; not for claiming a functional aspect (which the screen face topography is substantially) but for obviousness based on prior art references.  I suggest the prior art references had similar screen face layouts because of convergent evolution based on efficient Function. See screen layour design patent at: https://www.google.com/patents/USD618677?dq=D618,677&hl=en&sa=X&ved=0CB4Q6AEwAGoVChMIh-D1g9y_xwIVAzGICh3Kig9r

Why does the PTAB not invalidate design patents based on claimed features being functional?

August 23, 2015

Dimmable Control of mRNA Expression (and Some Cool New Acronyms)

Nice to see Los Alamos National Laboratory is keeping their information systems busy in biology.

I haven't read the actual ACS article, but it appears that the cis-repressor RNA (crRNA) binds to the ribosomal binding sequence to block transcription of the targeted mRNA.  Since the ribosomal binding sequence is not unique to each mRNA, I assume the crRNA binding sequence also includes a short set of bases complementary (not complimentary - I learned that lesson) to the early peptide encoding sequence of the mRNA. 

Then, a trans-activator RNA (taRNA) must have sequences capable of competing for the crRNA, thus removing the crRNA from the target mRNA at some rate (variable to have the fine "dimmer switch" extent). 

Not having read the article, I wonder if I am right.  If they are doing it a different way, maybe I should write a patent application within the next 12 months.

See: a Figure accompanying the Abstract at:  http://pubs.acs.org/doi/abs/10.1021/acssynbio.5b00041

August 21, 2015

Patent Term Adjustment From Slow PTO Review Not Added to Later Sister Applications

This is only reasonable because the Applicant could have pursued sister applications in parallel (have you ever done this?).  At least the Terminal Disclaimer is not going to hurt.

August 20, 2015

Treating Generic Primary Malignancies, Custom Mutants, and Mixed Mode Cancers

The faulty genes associated with dedifferentiation and uncontrolled cell division must only number in the low hundreds (right?).  Can't we develop a therapy (miRNA, small molecule, antibody ...) individually for most of them?  There must be a lot of common mutations treatable across a variety of malignancies.  Even now, we are seeing effective uses of drugs for non-approved conditions.  Not a bad back up position, if the primary cancer type therapies fail.

Soon, more drugs and biologics will be licensed on mutation indications (customized treatments) instead of based on generic primary carcinoma indications.

Then, there are the cancers expressing combinations of various mutations.  Maybe we can mix up a combination of therapeutics.  Bartender, bring me a cocktail.

August 18, 2015

What Analgesic Works Best?

They say acetaminophen does not work well, then show data that it works almost as well as ibuprofen. 

Aspirin works pretty well for me. Usually I get relief (mild headache) with only one 350 mg tablet. I never started on the other analgesics after the first time I saw their chemical structures.  Aspirin looks nicer. 

August 14, 2015

Prophecy is the Solution to All 102, 103, and 112 Rejections.

Who knew an imaginary experiment in an examples section could deliver so much ammunition against both written description and enablement rejections.  And, they didn't even have to offer up an expert Declaration or post-filing data. 

I use Inherency arguments all the time against novelty rejections: 

Ex parte Levy, (17 USPQ2d 1461, 1464) which states that "[i]n relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art."  Just because an Examiner's reference could describe the claim doesn't mean it anticipates, unless all embodiments of the prior art meets the claim.  

Here, inherency comes again to the rescue, but this time in the context of section 112 rejections.  In Alergan v. Sandoz (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1275.Opinion.7-31-2015.1.PDF), glaucoma eye drops were held non-obvious, described, and enabled based on the promise in the applicationthat the formulation will work better than a standard old formulation.   

Written Description was adequate because the Applicants had possession of a formulation that in fact was apparently better than the standard.  The Applicant said it would work in the imaginary experiment of Example 5, but never actually showed any data.   

The claim was enabled because the claimed composition could readily be prepared and Example 5 said it should work to reduce intraocular pressure more than the standard treatment.  A patent does not need to guarantee that the invention works for a claim to be enabled. 

Great.  I am going to add imaginary Examples to alll my applications from now on.  Say the composition functions, and you can avoid novelty, obviousness, written description and enablement rejections based on a functional (wherein clause) element of the claim.  Now, how to get around that pesky section 101 subject matter rejection.

I wonder how well this would work in China. 

August 13, 2015

Proposed Reduction in Corporate Taxes on Profits Associated with U.S. Innovation

Considering the U.S. has the second Highest Corporate Income Tax in the whole World, it would be nice if the tax was reduced.  What better way to reward research and marketing of novel ideas?

Too bad the initial proposal includes a complex (and subject to abuse?) formula.  Hmmm, the tax break is based on "qualified gross receipts derived from the sale, lease or license of qualified IP", subtracting the expenses and deductions attributable to qualified gross receipts, and multiplying by the ratio of domestic research and development expenses to all expenses over the past five years to provide a reduced income for taxation.  Might cost me as much for my tax guy to figure as I would save in taxes.  Could be a big benefit to evil large corporations, though. 

Anything to reduce corporate taxes in the U.S. and motivate innovation.  Even President Obama admits Corporate taxes are tooo high. 

August 12, 2015

Another Hypersonic Jet Patent that Will Never Be Infringed

First, the TIME article shows the author's failure to understand either aviation or patents.  I guess Airbus "won" a patent which was approved for a one-year term".

The aircraft seems a bit me-too with three thrust sources (turbojet, ram jet, and rocket).  Seems to have issued because it has a weird combination of the three engines, the ram withdrawn into the fuselage and the rocket behind a door; running on hydrogen, with a delta wing ...

Still, fun to dream. 

See patent U.S. 9.079,661 at :   http://time.com/3982901/airbus-patent-supersonic-jet/

August 11, 2015

Antibiotic Resistance and Transfer of Resistance Readily Accomplished, Even Though Multiple Mutations Required

I am not sure what are the "strategies" in the article title to outsmart the pathogen - be more sparing in antibiotic use?   

Things are happening in the antibiotic resistance experiment, but I am not sure why after reading the article.  The culture of E. faecalis is exposed to tigecycline resulting in increased copy number and transfer of conjugative transposon (Tn916), originally a tetracyclene resistance factor.  Isn't this just bare bones selection?  Bacteria not upping tetM expression and transferring resistance in conjugation are at a selective disadvantage in the population of the culture.

It was interesting that the tetM (blocking tetracyclene) over expression is capable of blocking the related tigecycline.  Apparently through a similar (competitive) interaction for a ribosomal binding site, but requiring higher tetM concentrations to be effective against tigecycline. 

 See Abstract at - http://mbe.oxfordjournals.org/content/early/2015/06/24/molbev.msv133

August 10, 2015

Conjugated MenC Vaccine is Difficult to $cale Up

The last project I worked on at Chiron as a Process Engineer (before I got my first Patent Attorney job) was the conjugated MenC vaccine.  I heard it got licensed and saved the lives of a few collage students and military service recruits. 

Too bad the vaccine is so expensive and difficult to scale up; particularly, in a developing country.  I do recall that the process of manufacturing the vaccine was particularly difficult, hazardous, and expensive. 

Seems the product must be off patent by now (never was patented in Nigeria).  This should be one time low cost manufacturing (in India) may be appropriate.

August 8, 2015

EPO Productivity Up - Another Tale of Low Hanging Fruit

The turn over of EPO patent application files has increased substantially recently.  How about that 33% increase in grants! 

However, just like many statistics in life, you can't expect them to continue on forever.  Wherever extra efforts are made in a damaged environment result in more improvement than the same efforts in an already healthy environment.  Look at the recent growth in China, or improvements in some bad schools compared to successful schools.   

I just hope some of the cherry picked patents for grant are some of mine that have languished at the EPO for years.

August 7, 2015

Not all U.S. Utility Patent Applications Publish at 18 Months

It is so routine in my office to file a provisional and go on to utility that I was surprised to see that most applications do not publish 6 months after the U.S. utility filing date.

Still, the publication dates are 18 month, just 18 from what.  I remember a few years ago that cases often did not publish on the 18 month date because the USPTO seemed to get behind and publish at 19 or 20 months.

August 6, 2015

3D Printing of Pills - What Shape the Layers?

Pills in the photo look pretty plain.  They should have made them shaped like hollow teddy bears. 

Applying binding liquid to powder layers to eventually form a pill.  This may be new to pills, but is old in other areas.  I wonder how many licenses Aprecia needed to practice and what is the advantage over simpler candy coating technologies.

See a patent here:  https://www.google.com/patents/US20140065194?dq=8888480

August 5, 2015

Again, Stopping Indian Medicine Pirates.

Hmmm.  Bio-Piracy.   

It is not piracy to apply for a patent.  If your idea is not new, the patent will not issue.   

Of course ancient treatments are not patentable.  However, new methods of treatment, new processes of preparing compositions, extracts that have never been prepared, and new combinations of old compositions should be patentable.

Imagine the color of a man's head after hair loss treatment with turmeric!

August 4, 2015

Mitochondria and MS

It is possible that this work eyeing mitochondria is closer to the root of the MS problem than simple autoimmunity. 

The problem with many diseases without pathogens (bacteria, fungus, virus) is that they are complex with any number of system degradation results easily mistaken for causes.  What came first in MS, myelin sheath degradation, mitochondrial damage, or autoimmunity?  Causation, correlation, coincidence.  At least politics are not involved.   

Boy, have mitochondria been in the news a lot lately. 

August 3, 2015

Lame Rejections - Not a Work at Home Problem, but Lack of Effective Supervisory Authority. 

Just yesterday I was reviewing two Office Actions for my clients.  Each was a final Office Action that failed to address key arguments of my prior Response. 

In one case, there was never ANY discussion of rejected dependent claim 6 on the record.  This is because the cited prior art did not teach the claim.  Instead of allowing claim 6, the Examiner just ignored it, even after being challenged to state a case in the first Response.  It appears the Examiner wanted to get the case off her desk and it was too much work to process an allowance past her Supervisors. 

In the other case, claims were rejected in a conclusory fashion without application of any FACTS.  In fact, the facts show that the suggested combination of prior art elements would change the principle of operation in the primary reference and render it inoperable.  Rather that find new references, or present a fact based argument (too much work), I get these conclusory rejections.   

I am not saying the Examiner's are overstating their time, but are probably reacting to perverse motivations in the Patent Office system (under the protection of their Union and/or embarrassed Management, since Supervisors seem powerless?). 

Anyway, I routinely go over the head of such Examiners with Request for PreAppeal Review (RPAR) and Appeal Briefs.  And I almost always (eventually) win the Decision.

Maybe the PTO should have a policy of weighing Appeal Decisions against Examiners.  Maybe we should all Appeal more often.  Usually, I don't have to wait too long (though last week I did win a 3-year-old Appeal Decision) because I win the RPAR, or the Examiner does not want to put a childish Appeal Answer on the record. 

P.S.  I have arranged to Interview these with the Examiner and her SPE, which can ofter avoid steps to Appeal. 

[Finally found something of interest to write about after returning from a family funeral in Australia.]

 

July Entries:

July 27, 2015

Malaria Vaccine Prevents Only One in Three Cases, but Also Avoids 6 New Cases for Every Child Vaccinated. 

The benefit of the vaccine (plus combined preventive measures) is greater in reducing spread epidemiology than at preventing cases in particular individuals.  This is the bigger story. 

And, they have only spent $300 million on it so far. See the GSK release at:

https://www.gsk.com/en-gb/media/press-releases/2015/gsk-s-malaria-candidate-vaccine-mosquirix-rtss-receives-positive-opinion-from-european-regulators-for-the-prevention-of-malaria-in-young-children-in-sub-saharan-africa/

July 24, 2015

Long Disrespect for Unmet Needs - Obviousness

You think long felt need is a waste of time in litigation, try this argument in prosecution with an Examiner.

Too bad.  Long felt unmet need is strong evidence of non-obviousness.  If it was obvious to make this improvement, why did thousands of people with this problem for many years not come to this solution?

July 23, 2015

European Unitary Patent Fees May Be Down Drastically

A few months ago the suggested fees for a Unitary European Patent covering all EPO contracting states was stratospheric.   No one would have used the Unitary scheme.  I was sure the EPO committees would ever drop the fees enough to make validation in all EPO countries attractive.  Yet, here I see they may have found a formula that can work for some patentees, the EPO, and European national patent offices. 

The renewal fees for total European protection may be set at about the level as if the patentee had validated in the top 4 most commonly validated nations.  The article makes much of the fact that election of a Unitary patent would only save a few Euros over the 5 to 10 year renewal period.  But the real bonuses are much lower fees through the 10 to 20 year renewal periods AND the fact that the patent is enforceable throughout the 38(?) contracting states.  All this for the price of 4 countries. 

I am also surprised that the numbers represent a 5 year break even for the EPO (no big EPO profits, in contrast to the initial proposal), and the small rarely validated countries appear to have backed down on requiring the unitary patent to be a monetary windfall for them.

July 5, 2015

No Xenophobia for Engineered Transplants

First with the standard comments against xenotransplants - no swine for jewish patients (or is this actually not against the rule?).  Inhuma[i]n[e]  Hmmm.

I remember when I was studying blood banking, as a Med Tech intern.  I was surprised at the large number (beyond ABO/Rh) of antigens known to cause adverse reactions in whole blood cell recipients.  In transplants, the number is even higher (far beyond MAJOR histocampatibility - MHC antigens).  I can not imagine how many genes would have to be modified in a pig lung to reduce the host versus transplant rejection to an acceptable level.  Still, I suppose it is manageable, in the long run. 

July 4, 2015

Are Antibiotics Causing Our Obesity Epidemic?

 More on the influence of the microbiome on a person's health at all stages of life.  Attack a single species pathogen with antibiotics, and, wooops, you also wipe out a hundred other useful species.  The unintentional side effect is loss of protective commensal organisms, as has been well known for decades. 

Now, we see that these organisms, intimately associated with our immune systems and processing of nutrients (have you ever seen how many lymphocytes there are in all layers of the GI tract?), have a strong influence on the shape of our bodies.  That is, the undesirable balance of microbiome species after antibiotics can promote in obesity, and  later diabetes and high blood pressure.  See:

http://blogs.scientificamerican.com/food-matters/antibiotics-and-obesity-an-unexpected-casualty-in-the-war-on-microbes/

Thank god I was too poor to go to the doctor when I was a kid.  Amazing that modern pampered kids go through a course of antibiotics at least once a year (probably for viral infections).  This has got to stop. 

July 2, 2015

What Defines Chinese Bioethics?

Apparently there is some international peer pressure on Chinese researchers not to use CRISPR to modify germ lines.

I am curious.  What is the basis of Chinese ethics?  The article raises Confucianism.  How well has it survived communism, the cultural revolution, and the rise of capitalism?  Anybody?    

July 1, 2015

Plastic Surgeons Must Consider Client Culture in Breast Implant Surgery

What can I say.  Apparently desired breast shape, size, and appearance varies north to south and young to old. 

June 30, 2015

How Y. Pestis Became a Pest

I am not sure how acquisition of an entire new gene can be considered "single small genetic change" in Y. pestis.  The article does not mention that Pla exhibits a plasminogen (Plg) activator activity (PAA) that promotes the cleavage of Plg to the active serine-protease form called plasmin.  This probably makes the pest less subject to certain passive immunity cascades. 

June 29, 2015

If 85% of Patents are Invalid, Why Hasn't the Market Responded?

The value of patents has always been clouded by compounded assumption errors.  The average value of patents has never been accurate to within 25% [I just made this up; like everyone else does].  And, the value of specific patents is always biased by the dreams of the owners. 

OK.  85% of the inter partes reviews have gone against patent holders.  This is low hanging fruit and will taper off.  This surge of invalidations was just a big wave flowing past because the AIA had lowered the transaction cost to dispute validity.  The wave also surging due to certain recent Supreme Court holdings and dicta. 

I suppose one reason that the "grief process" has gone straight from denial to acceptance is that there had really been no denial.  The dirty little secret may have been that the weakness of many patents was rumored and already priced into the market.     

June 25, 2015

Relative Patent Numbers Show Electronics Over Mechanics in Cars

Just another data set that shows cars are becoming rolling computers. 

I can't complain too loudly.  I just finished putting a computer programmable multi-spark ignition controller in one of my 42 year old Datsun 240Zs and found I am getting 10% (!) more gas mileage.  Though, the first controller I put in was unreliable.  And, I have a backup wiring set in the glove compartment to take the controller out of the circuit, if if ever goes bad on the road. 

Maybe not surprising that the 100 year old engine patent category was not near the top in numbers of patents. 

June 23, 2015

One of Skill Can See Structure and Scope, Even in a Software Claim. 

The abundant functional and result oriented language in software claims has often made me cringe.  However one of skill in the high tech arts knows the options, and specific structural language is often not required in this field. 

Here, in Williamson v. Citrix, ( http://patentlyo.com/media/2014/12/13-1130.Opinion.11-3-2014.1.pdf ), a "graphical display" limitation was deemed to have relatively broad scope by the Federal Circuit, and a "module" limitation had enough structure to avoid being deemed a means plus function limitation. 

The infringers were claiming non infringement due to narrow construction of the graphical display, and invalidity for alleged lack of an embodiment in the specification for a means plus function limitation.  The Federal Circuit disagreed on both counts. 

The claims required graphical display representative of a classroom.  The infringers wanted to limit this to only the exemplary display of the figures.  The Court found no suggestion on the record that Williamson intended or one of skill would have so limited the term. 

The infringers wanted the "module" term to be interpreted as a "means" (for alleged lack of structure of the term in the claim) so that they could trigger indefiniteness invalidation for lack of description in the specification.  They even went so far as to argue the point citing an unpublished case.  However, a module is a structure, and the whole phrase "a module for providing a first graphical display" offers even more structure to one of skill.  So the Court held it to be more than a means limitation.

In the end, the "district court erred: (1) in failing to appreciate that the word 'module' has a number of dictionary meanings with structural connotations; (2) in placing undue emphasis on the word 'module' separate and apart from the claimed expression 'distributed learning control module'; and (3) in failing to give proper weight to the surrounding context of the rest of the claim language and the supporting text of the specification in reaching the conclusion that the drafter employed means plus-function claiming."

To put a cherry on top, the Court awarded costs to Williamson.  Makes me feel a little more comfortable drafting software applications an claims, even in light of recent negative holdings. 

June 17, 2015

PTAB Patent Eligibility "Threshold" Not Always Higher Than Novelty/Obviousness - First 6 Months 

It does not seem logical.  Having a threshold step more stringent than the following steps is a faulty process.  The article mentions a case where the claims are considered routine and conventional (35 section 101) even though they are not obvious (35 section 130).  How can something you wouldn't think of be routine?    

The article does mention several instances where one Guideline factor (e.g., lack of preemption in the field, or the presence of a simple device) provided eligibility, even where other factors were not in favor.  However, PTAB decisions are non-precedential.  A lowly Examiner will no way take the risk of allowing subject matter by giving significant weight to one factor alone.  In fact, if a claim is weak on one point of the weighted subject matter eligibility factors (see - http://www.uspto.gov/sites/default/files/patents/law/exam/bilski_guidance_27jul2010.pdf) , the Examiner will often focus on that weak point and dismiss favorable factors. 

Still, it is good news that a case can get through section 101 if there is a limited scope (no preemption, means claims) further limited by a machine and/or transformation.  Software, business methods, and apps out there - focus on your business plan embodiments and make it do something physical. 

At least the first 6 months of PTAB decisions give me some hope.  If you are willing to appeal (and I am), and have a lot of TIME to await an Appeal Decision of the PTAB, you might receive an allowance of your claims having the dreaded natural or logical aspect. 

June 15, 2015

Thanks for the Natural Phenomenon, Now Go Away! Fed Circ Invalidates Fetal NA Detection Method

Sequenom has finally lost in the Federal Circuit.  Validity of generic claims to detecting paternal nucleic acid sequences of fetal origin in maternal blood are held to be invalid.  The presence of the fetal nucleic acid is a natural phenomenon. 

The good news for Sequenom is the priority date for the US6258540 patent is 1997.   See https://www.google.com/patents/US6258540?dq=6,258,540&hl=en&sa=X&ved=0CB4Q6AEwAGoVChMIma_A_fuMxgIVBqWICh3oYwk7 . I hope they got a lot of good years out of their ineligible invention before the rules changed with Mayo in the Supreme Court. 

There is a lot of focus on the generic independent claims in the Court's discussion.  See Claim 1:

1.  A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

I wonder if things might have gone differently had an independent claim been narrow to the intended market embodiment.  The Court (see - http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1139.Opinion.6-10-2015.1.PDF ) said the absence of complete preemption does not demonstrate patent eligibility, but the weight of the preemption factor could have been minimized with narrower claims.  Focus on the "best mode" or intended market product may well have enhanced other factors, such as providing a diagnostic device or physical transformation of the sample. 

June 12, 2015

Who Owns CRISPR IP? - Notebooks, Filing Dates, Publication Dates, Fast Track

I imagine the disclosures of the earlier UC Berkeley and MIT patent applications do not totally overlap.  Under the controlling old first-to-invent rules the intellectual property of CRISPR may be divided depending on what they have in their specifications and notebooks.   

The whole thing could have been simplified for UCB if they had requested early publication.  I have a similar situation with one client (less dramatic subject matter) and I will be watching how events turn. 

June 11, 2015

Review of Rules Impacting Protection of Life Science Inventions

This article is a pretty good review of issues around protection of biologic products. 

Having been in the biopharma industry for more than 30 years, I find it amusing that the article refers to life sciences patents as an "emerging area".  Actually, there was a boom in the '80s and a lull in the '90s.  Small molecules screened from arrays have not met their promise yet.  However, the genome projects, improvements in MABs, and miRNA applications have boosted biologic patenting.   

Not mentioned in the article was forces against the emergence of biologic intellectual property.  Yes, there must be a use for the nucleic acid sequence, after the Court ruling that single nucleotide polymorphisms (SNPs) do not have utility, in themselves.  But, further, the sequence can not be a natural sequence (cDNA qualifies for having introns unnaturally removed).   

The "trend" in biologics and medical device businesses has been alliances and acquisitions for some time (how old is the author?).  More often than not, research does not go as desired or expected.  Often research leads down interesting paths not in the corporate business plan.  It is far more predictable and inexpensive to buy a smaller company what has proven technology that fits the plan.  (I remember my brother spent $20k fixing up a Corvette that someone else eventually bought for $11k.) 

A real trend may be the combination of devices and biologics.  It is becoming more and more common for medical devices and prosthetics to have a biologic component, e.g., to generate a signal, deliver an activity, or enhance functions of devices.  

In order to qualify for patent protection, it is best if the invention is different from natural materials in some way, does not monopolize a natural phenomenon, and is in combination with other unique structures non-obviously solve a defined problem.  See, e.g.,  http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products.pdf  and  http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf

June 9, 2015

Alice was Less a Mutant than Funk and Flook

The article does not seem to make total sense.  Yes, the Funk Brothers and Flook  decisions were judicial error ("mutant"), but it does not follow from the facts that Alice is also a mutant.  

I believe the Supreme Court (SCOTUS) was incorrect in the precedential Funk brothers case (https://www.law.cornell.edu/supremecourt/text/333/127 ) holding that a novel combination of nitrogen fixing bacteria, working in inventive ways was not subject matter for patenting.  Section 101 provides that new compositions of matter are patent eligible. It is routinely acknowledged that all inventions are combinations of natural things.  The Funk composition was a new combination of Rhizobium, e.g., in association with certain legumes.  At least seeds inoculated with the new combination should have been considered eligible for patenting.   

In Flook the claims were directed to updating alarm limits during catalytic conversion method in a device.  The claimed  method was identical to prior art systems except for the use of a mathematical algorithm to precisely control timing of a process point in an old old method stepno hardware.  (See, https://supreme.justia.com/cases/federal/us/437/584/ ).  The inventive aspect was essentially the algorithm. 

I do not see how these cases bestow a mutation onto Alice.  It may have been a mistake to deem Funk and Flook as patent ineligible, because they at least had some elements of compositions or systems.  Meanwhile, Alice, though a method, seems to be simply a mental data manipulation adapted for increased speed and efficiency with the obvious computer implementation.  Even then, the independent claim did not even bother to cite a computer.    

For me, the annoying part is much talk of "inventive concept" in these cases.  Sounds like the European Inventive Step or U.S. obviousness analysis.  Throughout all these cases it seems the SCOTUS analysis starts with evaluation of whether the claim is solely to a natural phenomenon or algorithm, then moves on to an analysis evaluating obvious of the  combination (which would have been better reviewed under the more clear rules of section 103 obviousness analysis). 

Back to Alice ( http://www.supremecourt.gov/opinions/13pdf/13-298_7lh8.pdf ): the claims at issue were directed to an the abstract idea of intermediated financial settlements. Under “the longstanding rule that ‘[a]n idea of itself is not patentable.’"  Quoting Mayo "an element or combination of elements [must be] sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.”  However, there was no machine or transformation of anything physical in Alice, with only information flow carried out in existing computers long in use.  Alice may have been a non-mutant ruling.  

See Bilski Guidelines for weight to be given factors in determining elegibility of software methods:  http://www.uspto.gov/sites/default/files/patents/law/exam/bilski_guidance_27jul2010.pdf

June 8, 2015

Multi-GMO Potato Fights Rust, Bruises, Worms, Cancer, and Fighter Jets. 

Yes, but wouldn't such a Multi-GMO potato come up out of the ground and knock down buildings in Tokyo, while being fired upon by fighter jets?  

June 6, 2015

Brains Have Lymph Flow Through Dura Mater (Exciting!) 

So strange.  I had just asked my neurophysiologist wife about brain lymph (interstitial fluids) a couple of weeks ago and she wasn't sure where brain lymph flows, but into the cerebro-spinal fluid (CSF).  We had been talking about the recent papers on how the space between brain cells expands to clear waste while we sleep (see, http://www.nih.gov/news/health/oct2013/ninds-17.htm).  (Interesting dinner conversations we have.) 

I knew there had to be some way the brain handled interstitial fluid flows besides just dumping them into the CSF. 

June 5, 2015

The Magic Bullets Against Cancer are Information and Immunotheraphy

I was at Cetus/Chiron when we licensed Proleukin (IL-2).  It seemed to help some with melanoma, and for some orphan indications.  There was experimentation with treating patient T-cells in vitro with the cancer cells to expand the killer T-cells specific to the tumor.  Helped a percent, and made another percent not feel good. 

The article dances around it, but gene sequencing and bioinformatics should be the key to identifying those who would benefit from certain "magic bullet" treatments, and those who will not. 

June 4, 2015

How Long to Train a Good IP Judge - Chinese Judges Leaving Bench

The Chinese justice system will never retain the best until the Judicial System is a Co-Equal to the Communist Party

June 3, 2015

Print My Organ in Living Color

A common thread with most 3D printing is there is a single media, e.g., a plastic polymer or metal.  Printing 3D organs should not be all that difficult in the long run once the stream of media can be intermittently changed to provide the variety of different materials required in a tissue or organ.  This could be accomplished with a serial or parallel ejection of, e.g., minerals, polymers, fibroblasts, glandular cells, endothelial cells, to print a picture of a tissue cross section (maybe based on photographs of actual tissue cross sections). 

It might not be that far away for simple tissues.  And, there should not be too much politics against this, as long as the cell source is the patient's own body.

June 2, 2015

Using CRISPR to Attack Nosocomial Infections

When I first saw this article title, I thought there would be a lot of problems in using phages to fight a toxemia.  For example, rapid clearance, limited bacterial genus targeting, patient immune response.  The irony of attacking the bacteria with their own "immune memory" system did not escape me.

In reading the article, I see they intend a more practical use.  The idea of targeting nosocomial infections by killing bacterial in hospital surfaces is a good one.  This, particularly since the phages are configured to provide a selective pressure against bacteria having antibiotic resistance. 

June 1, 2015

Latest Humanized Bispecific Antibody Links Killer T to Target Lukemia Cells

The bispecific antibody has a T-cell specific (CD3) arm and an arm against CD20 (common in certain leukemias). 

Genentech expects it may have a complementary action with the current Rituximab (anti-CD20) monoclonal.  Although the two antibodies appear to target the same antigen on leukemia cells, Genentech expects that competition won't be an issue, and the bispecific antibody can help recruit additional T-cells to attack the opsonized leukemia target.

The “knobs-into-holes” technology (http://www.ncbi.nlm.nih.gov/pubmed/8844834) to minimize homodimer contaminants is apparently old news, but a fun way to favor heterodymers during bispecific antibody production. 

 

May Entries

May 29, 2015

Most Important Invention - Device to Test Antibiotic Sensitivity

Rapid determination of antibiotic resistance is one of the most important technologies on the planet.  The old Kerby-Bauer assay using antibiotic disks on a lawn of the bacteria took a couple of days, but at least also gave a quantitative level of sensitivity.  However, the result was often too late because the patient was already being treated.  And, the doctors never ordered the test because is was slow and expensive.  

Contrary to the comments in the article, I do not believe the resazurin is metabolized (directly) by the bacteria, but undergoes a redox reaction due to the presence of metabolizing bacteria in the nanochamber confines. 

It should not be hard to develop a means to provide the antibiotics in an array, and in a range of concentrations for identification and quantification of resistance.   

I have been amazed at how long it has been taking to develop a good practical test for bacterial antibiotic sensitivity.  These inventions could save thousands of lives every year AND slow the progress of antibiotic resistance evolution.  

May 28, 2015

Filing early AND often is the good rule. 

If you file early, you may not have the best details and variety of species, and best mode.  But, first-to-file forces this hand.  To cure the defects of early filing, you must diligently further develop the invention and file a follow-on provisional application whenever you have substantial new material.  By the end of the 12-month provisional period, you should have a strong position against competitors (unless they have been filing during the 18-month period before publication of their application!). 

More good news is that filing additional provisional applications is not expensive (particularly for small and micro-entities).  Just throw your new examples onto the end of the previous application and make some adjustments to the general text referring to the new material. 

May 27, 2015

Adjusting Car Computer Software Said to Infringe Copyright, and Risk Death

If I buy a book and cross out a sentence and replace it with one I like better, I am not violating copyright law.  This is what happens with a car's software is changed, e.g., to modify the rpm at which the transmission shifts. 

The article seems naive.  Perhaps the copyright issue arises when a third party sells a whole new set of software code wherein a part is changed, and the rest remains as in the original code.  The third party has copied the "creative" original work.  

The annoying part are disingenuous arguments about safety when the real motivation is to keep control of the dealer's high margin service. 

Reminds me of the old days when the car makers each had different on board diagnostics (OBD) standards, again, so they could control service and repair of cars they manufactured.  Was a time a machine to read the computer data for a car cost thousands of dollars and worked only one make.  Even the independent auto mechanics couldn't afford the capital expense of buying all the OBD readers for all the makes.  After Congress interfered (law requiring a uniform OBD standard), now I can read the OBD on all cars with a $35 blutooth adaptor talking to my smart phone. 

I still do all my own car mechanics, even on new model cars.  Computers are not an issue on my 1972 240Z.  http://www.biopatent.com/cars.html

May 26, 2015

Software Claimed as a Device Must have the Structural Means

Device claims were invalidated as ineligible software subject matter for allegedly not including any of the four patentable subject matter types of processes, machines, manufactures, and compositions of matter.  I am not sure why the patentee admitted that the claim elements are all software elements. 

 Invalidated claim 60 was to, e.g., a data input means, output means, audio playback means.  Wouldn't the audio playback means include speaker systems?  Means plus function claims are limited to those examples in the specification, and ... examples of audio playback means included, e.g., D-A converters and audio speakers.  There were exemplary hardware means too for the input and output means.   See patent specification at: https://www.google.com/patents/WO2001031634A1?cl=en&dq=5,799,273&hl=en&sa=X&ei=hQRhVdPXI8y2oQSqiIDoDA&ved=0CCwQ6AEwAg

Claims were rejected based on the statement that “[s]oftware may be patent eligible, but when a claim is not directed towards a process, the subject matter must exist in tangible form. Here, the disputed claims merely claim software instructions without any hardware limitations.”

Lesson one, I guess, is not to have the claim novel software as a device, e.g., without uniquely interacting hardware.   In any case,  one should not place all their bets on software claims with solely functional limitations (means limitations not listed in the specification), even if the claims are process claims. 

When the preamble characterizes the claim as a device, the claim drafter better put up or shut up.  I guess software claims may do better in the form of a process.  Still, it kind of gets on my nerves when I read software patents and see so much talk of means and results without specific examples.  I guess the expectation is that one of skill in the art would know how to mash together code to practice the invention without undue experimentation.  However, it is looking more and more like this kind of specification writing and claims are not going to fly anymore. 

Worse yet, as here, it appeared there was hardware and examples of "means" yet the Court gave it no weight.  See case at:

http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1258.Opinion.5-19-2015.1.PDF

May 25, 2015

Innocence of Muslims Copyright Takedown Reversed

The movie may be distasteful, but the take down had so many flaws it is amazing the CA Federal Court granted the injunction and take down. 

It is unworkable that each actor in a movie would have a copyright interest.  "I was the bearded extra in the crowd waving a flag in Gone with the Wind.  Stop showing it because I am no longer comfortable with my performance." 

Ms. Garcia seems to have been genuinely mislead by the movie producers.  However, she did not herself fix an integrated work.  It is old law that she did not have a copyright.  

The worst mistake of the CA Fed Ct was the unconscionable prior restraint on political speech (the content of which they probably did not agree with).  Not in America.  Here, we have a right to say things that make us look mean or stupid.  Then, others can judge our stupidity (unless someone interferes). 

May 24, 2015

Patents Can Issue to Correlations of a Natural Sequence to a Disease State

Well, we have here an example of claims issued in a patent for a correlation of a natural nucleic acid sequence to a disease state. 

The independent claims are methods requiring, e.g., obtaining a sample of a skin lesion ... detecting the presence of a nucleic acid molecule expressed from C6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218, and ... comparing the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample to the presence of C6orf218 in a non-melanoma sample. 

Well, you can not practice these claims in your head.  But this looks like the natural sequences rejected in Myriad and the correlation of natural substances to disease states rejected in Mayo.  Still the allowance.  Why?

The claims incorporate steps that amount to significantly more than the natural principles themselves because the steps do not merely incorporate conventional, routine techniques while failing to incorporate some other inventive concept.  Was this case issued without a section 101 subject matter rejection because the claims were not obvious? 

The claims are more than the natural phenomenon, and go out of their way to not monopolize the natural sequence.  The claims are greatly narrowed by the limitation that detection be by labeled probes.  The claims do not monopolize the natural nucleic acid. 

The history of the patent prosecution shows that the Examiner agreed that "detecting melanoma in a human subject" or "diagnosing melanoma in a subject," by "detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample," is not taught, alone or in combination, by the art cited in the Action.  I believe this is inappropriate analysis of claim obviousness (35 section 103) in a section 101 rejection, but I am starting to get used to it.  The key here seems to be that, compared to some rejections, the Examiner does not unreasonably start with the assumption that the natural principle is known.  (Although many Examiners believe the Patent Office Guidelines require analysis based on a construct as if the natural phenomenon were previously published.)  Anyway, it does help if the analyte detected in the assay was not previously known or if the analyte was known but not associated previously with the disease state.

So, an allowance can be had where the analyte was not known and the inventors graciously limited detection to what they intend to practice in the market place (even if one could obviously engineer around the claims by detecting the nucleic acid without a labeled probe).

If DermTech starts making any money on this, we will see if 1) the claims hold up under the scrutiny of post grant review at the Patent and Trademark Appeal Board (PTAB), and/or 2) someone else sets up an assay quantitating the C6orf218 without using a labeled probe.   

May 22, 2015

I Want a Copyright on my Patent ... and a Patent on My Copyright

I had always been under the impression that text and images of a patent application were in the public domain.  Maybe, defacto, since no one ever files a suit alleging copyright infringement of patent content. 

May 21, 2015

Design Your Patent to Take Total Infringer Profits

The case seems unfair to Samsung.  Just because the PTO let issue an improper Design patent claims to functional elements, Samsung is stuck with huge damages, mostly not associated with the infringement.  The Court even admits, in the context of trade dress, that the claimed design is functional: 

"Here, all factors weighed in favor of the trade dresses being functional and thus unprotectable under trademark law."

See the case at: http://patentlyo.com/media/2015/05/Apple-v-Samsung.pdf

Yet in the context of the design patent  ... “Samsung contends that rectangular form and rounded corners are among such elements that should be ignored in the infringement analysis.”  Id.  But, the court held, the precedent cited by Samsung did not support a rule “to eliminate elements from the claim scope of a valid patent in analyzing infringement.”  

That is, even though the design is acknowledged as functional (Design patents are supposed to protect only the ornamental, non-functional, aspects of a product), the Court hands were tied because the functional elements (e.g., rounded corners) were in the scope of the issued patent, which is presumed valid. 

Here is a great place to offer Inter Partes Review (available to Utility patent infringers, but not Design, I believe). 

Then, damages were killer.  35 U.S.C. § 289 - whoever sells or exposes for sale any article of manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit, but not less than $250.  Because the Samsung phone had rounded corners, they have to disgorge all profits on the phones sold. 

I am going to recommend Design patents to my clients more often. 

May 20, 2015

Do We Need A CRISPR Human Gene Pool?

Ironically "they missed the target a fair amount of time and hit a lot of other targets."  Isn't the powerful thing about CRISPR that it is highly specifically directed?

May 19, 2015

Trans-Pacific IP Protection vs Generic Drug Availability

Considering their constituency, I suppose the amfAR positions are rational for them.  Weaker IP protection for U.S. inventions around the Pacific would probably not reduce innovation in the U.S. much, but provide more generic drugs in the foreign (less inventive) countries.  Essentially, a transfer of information wealth from the U.S. would benefit a number of people around the Pacific.   

amfAR suggests they "fully recognizes the important role that IP plays in incentivizing investment in lifesaving medicines, the precise levels of protection necessary to adequately support this research and development are highly debatable." 

See more at:

http://www.amfar.org/Issue-Brief-Trans-Pacific-Partnership-PR/

And, actual amfAR Brief at:

http://www.amfar.org/Issue-Brief-Trans-Pacific-Partnership-PR/

Still, some of their statements seem naive or to intentionally misstate facts to justify their political position.  For example, they state it is unfair for infringers to have to show invalidity of a patent.  amfAR suggests the proposed Trans Pacific Partnership (TTP) agreement would "reverse the burden of responsibility so that patent challengers would have to prove a patent’s invalidity rather than the patent owner".   I assume this poorly constructed statement meant to say the old rule required the patent owner to prove patent validity before they could accuse an infringer.  Well, the actual old rule has long held that a patent is presumed valid (because it has been granted after review by a patent office).  So, the TPP restatement of the rule is not a reversal of the burden; and, in fact the burden demanded has been met, to first show validity.  It should not be considered unreasonable for an infringer to then show invalidity of a patent, if they choose this as a defense to an infringement accusation. 

Next, amfAR goes into the usual mischaracterization of "improvement" patents as some way for "multinational corporations" (code words for bad guys) to unfairly extend the terms of their patents.  amfAR says: 

“[T]he TPP requires that countries provide patent protection to any new uses or methods of using a known product.” Such provisions have been used to continually extend periods of patentability through a practice known as “evergreening" ...to prevent generic production." 

First, please note that almost all inventions are "improvements" over prior technology, and this is recognized in the definition of what is patent eligible subject matter the world over (see, e.g., U.S. 35§101).  If the improvement is new and not obvious over the old drug, it is patent eligible.  If it is an obvious improvement (e.g., "minor changes are made to existing patented drugs in order to justify a new patent"), the "improvement" would not be issued in a patent.  If the improvement is new and non-obvious, it is a contribution worthy of a reward of patent. 

Second, even if the improvement is patentable, it in fact (literally) does not "prevent generic production".  The generic drug, as originally licensed with expensive clinical trials by the mean old multinational corporation, can be practiced as generic drug with support from those clinical trials.  The original patent is expired and a gift to the public domain for all to practice.  It is untrue that protecting patentable improvements "would allow the re-patenting of older drugs with minor modifications."  The improvement can not be practiced 1) because it is patented, and 2) there may not yet be clinical trial data on the improved drug. 

So, amfAR is probably right that more lives may be made longer and more comfortable if the levels of protection are not increased for patented drugs.   However, they could be less political by not mischaracterizing the facts, and maybe by saying thanks to those who have spent their lives inventing life-saving drugs.  What drugs has amfAR developed?

May 18, 2015

European Unitary Patent Fees Still Do Not Add Up

Wow, maybe we in the U.S. should start charging renewal fees Every Year and get rich, like the Europeans!  Humor aside, the price is way tooo high, even for my bigger clients. 

What is not mentioned in the article is the politics within the EU on the topic of patent fees.  As with the monetary union, there those who generate the most income, and those that want a windfall by "sharing".  In order to satisfy all the 30, or so, members, they would have to either demand even larger fees (killing the unitary concept) or requiring one country (Germany?) to subsidize the others.  

May 16, 2015

Preamble Limitations Can Not Save Claim Body in Subject Matter Rejection

There is a general rule that limitations of a preamble must be considered, e.g., if necessary to complete the structure of the claim.  The Examiner's often ignore this rule in 102/103 rejections.  When they do, instead of arguing, I simply amend the preamble limitation into the claim body. 

See, e.g., MPEP 111.02   Effect of Preamble - “If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim.” Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999).  

Here, it seems the rule is even less respected in the context of section 101 eligible subject matter rejections.  Still, the bigger problem may have been the failure to connect the claim body better with the preamble limitations, e.g., by reciting interacting structural elements or physical interactions.

May 15, 2015

New Rules for Reporting Nanoparticle Production

There are many exemptions, including wherein use is for R&D or medical devices. 

May 14, 2015

Not the Patent Rolls, Dir. Kappos, but the Trolls

I think the main premise of the article is misplaced. I have not seen so much anti-patent as anti-"troll" hysteria. And the problem there is not the patents so much as the Federal Court system configured to allow victory to those most able to win a battle of attrition.

May 12, 2015

Virtual Software Does Not an Allowable Patent Make 

I do most of my patent drafting in medical technology and mechanics (although I do have staff who do work software).  I have to describe how structures interact to provide a desired functional result.  From this perspective, I have been somewhat disturbed in reading software patents when I see purely functional language.  Seems it was the style in software inventions for quite a while.

Of course, it is not necessary to write in your specification what is commonly known in the art.  See, e.g., In re Myers, 161 USPQ 668, 671 (CCPA 1969).  However, if this can stand in for your claim function, maybe your invention is not new (or at least obvious). 

Seems all the software patent drafters needed to do was to provide a block flow diagram of the software algorithm and some text describing alternates for each step of the process. One should be able to patent an invention involving software, but the data is the work piece and  the inventor should be able to describe how the data is manipulated to provide a desired result. 

May 11, 2015

America Invents Act - Solutions and Remaining Problems

Funny thing, of the seven changes brought by AIA, there is no mention of first-to-file.   

Anyway, I think AIA has been a good thing, by enhancing patent quality.  I get a little nervous though, after the quality initiative of Director Dudas, wherein Examiners were terrified to issue even a good patent for fear of losing their jobs.  Big focus was on preventing "false positive" allowances, and no consideration was given to the huge loss given to inventors receiving false negative rejections. 

Yes, the whole patent assertion thing had gotten out of hand.  The main value of the portfolios (of the PAEs and giant corporations too) was the fear of Federal Court lawsuit(s) costs, not the value to the IP.  OK, we are addressing the assertion of invalid patents, e.g., with inter partes review.  It is great that AIA has provided a much cheaper and faster route to resolving patent validity issues. 

However, a major issue still being ignored (in patents and all litigation) is the unethical use of expensive Federal Courts in battles of attrition, where evil doers force innocent parties to accept injustice.  Loser pays may help this a little, but will not solve the abuse of the Court system.    

May 9, 2015

Measles Infection Causes Immune Suppression - Vaccine Avoids

Geez.  And I thought I was strengthened by my childhood measles.  What does not kill you does not necessarily make you stronger. 

May 8, 2015

SCOTUS May Affirm Obviousness of Solving a Problem Not Found in the Prior Art  

After KSR (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2006)) first came out, everyone thought it would destroy our ability to argue against obviousness (103 rejections) based on combinations of references.  Before KSR, there was more weight given to the fact that two references were in different fields of technology.  More importantly, pre-KSR one could argue against obviousness by pointing out that there was no express "suggestion" in the cited prior art to actually make the combination of elements describing the claim. 

Well, my allowance success rate actually went up because KSR also strengthened the concept that it is not obvious to take an element from a secondary reference and incorporate it into a primary reference in a way that requires it to function differently.  After KSR there also seemed to be more respect for the argument that it is not obvious to incorporate an element that would require the primary reference to change its principle of operation.  So, KSR was not the disaster we had expected.

KSR also reiterated that "obviousness" depends on whether evidence shows that persons of ordinary skill in the art had a "reason to combine" earlier technologies into the claimed invention, such as to address a "known problem." 

Now I see that Federal Circuit case SCIENTIFIC PLASTIC PRODUCTS, INC., v. BIOTAGE AB (  http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1219.Opinion.9-5-2014.1.PDF ) will go before the Supreme Court.  Here the "obvious" combination solved an unstated problem, but the problem was found to be subjectively "implicit".   

The facts show that the invalidated patent protected certain low pressure chromatography cartridges with an easy open cap sealed with complementary inclined sealing surfaces to prevent leakage.  The primary reference used an o-ring seal and the secondary reference presented a soda bottle cap seal with complementary inclined sealing surfaces. 

OK, I have a gut feeling that it would have been obvious to combine the inclined seals with the primary reference cartridge.  However, this may be another example of a bad facts making bad law.  From my point of view, adding the inclined surface seal would change the principle of operation (o-ring) in the primary reference.  More to the point, the only place a problem is identified concerning the need to seal the low pressure cartridge is in the patent specification itself.  The Court finds it obvious to solve a problem that can not be found in the prior art, but only in the patentee's specification. 

For me, this could be a big problem.  If an Examiner can just say he has a gut feeling that the problem was implicit, that "guts" the problem solving requirement of KSR.  What would we have left?  In light of recent SCOTUS decisions, I have little hope Scientific Plastics will be overturned.  I just hope the Justices do not throw in a holding (dicta is usually enough for an Examiner) that further supports hindsight identification of the problem solved by reference to the patentee's specification. 

If Scientific Plastics is affirmed, let's hope it is ultimately no more a disaster than KSR was. 

May 7, 2015

One Way to Get More Value Out of Your Mayweather Fight Ticket

Boy, this journalist really does not like boxing.  But he has a point that filming a boxing match is not copyright infringement.

May 6, 2015

Vermont - The Non-GMO Mouse That Roared

In the long run this may be a good thing for GMOs.  There is so much erroneous bad press on GMOs that maybe it is time for people to find out that GMOs have always been everywhere and done no harm.  And, to find out it will cost more for lower quality food if they decline GMO.

May 5, 2015

Design Patents - Ornamental and Non-Functional?

The article fails to mention clearly that design patents protect the ornamental, non-functional, aspects of the object.  For example, the attractive contours or relief designs on a pump handle.  This should not cover the functional aspect of the handle, e.g., structure ergonomically presenting the hand grip. 

Maybe the lapse is intentional.  There have been cases where functional aspects were protected by Courts that seem to misunderstand the limitations of design patents.  I was blown away by the victory of Apple in protecting a cell phone shape of a rectangle with rounded corners.  Rectangles are a standard functional shape for packaging (oh, yeah, design patent subject matter has to be NEW) device components, and must have rounded edges for toughness and to avoid tearing at people and pockets.  Do you want a smart phone with sharp edges?

See the iPad design.  Note the grey or dotted aspects are not protected - only the solid lines. 

http://www.businessinsider.com/apple-ipad-design-patent-2012-11#heres-the-overall-look-of-the-first-ipad-1 

Anyway, I have noticed an increased interest in design patents lately.  In many cases, you can get a lot of bang for the buck.

May 4, 2015

More on Biosimilarity and the Patent Cliff  

"Biosimilarity" is the biologic drug counterpart for "Equivalency" in the generic drug field.   

Of the three hurdles to marketing biosimilar drugs (regulatory exclusivity periods, regulatory proof of biosimilarity, and patent exclusivity periods) the most difficult seems to be the patent exclusivity aspects.  Biosimilar manufactures can meet the FDA regulatory hurdles, but often try to get a head start in the race to the market and become entangled in tit-for-tat patent actions.   

As a patent approaches the end of enforcement, the biosimilar makers can choose to correspond and cooperate with the original manufacturer (though the Courts have confirmed this is not a requirement).  We are not seeing this optional up front communication between original and biosimilar manufacturers.

Meanwhile original manufacturers monitor regulatory filings to see if the new biosimilar manufacturers are trying to develop data for regulatory approval, so they can sue early. 

To counter, the biosimilars file IPRs (interpartes review) cases at the PTAB (patent and trademark appeal board) alleging the patents are not valid.   

To counter, the original maker may also assert their improvement patents (e.g., dosage methods, improved formulations, manufacturing) which were filed later and have later expiration dates.  

Such a cat and mouse game.  At least "pay to delay" is out the window for generic drugs and is expected to apply to biosimilars, as well.  See Federal Trade Commission at:

https://www.ftc.gov/news-events/press-releases/2014/12/ftc-staff-issues-fy-2013-report-branded-drug-firms-patent

 

April Entries:

April 29, 2015

You Turn Me Inside Out - Flipping Algae Gastrulas

In the process of embryo formation, a morula of cells becomes a hollow blastula sphere. The sphere evaginates to become a cup-shaped gastrula, and eventually the gastrula everts to flatten out as a three layered (exoderm/mesoderm/endoderm) structure. 

This article and film show how an algae accomplishes the tasks of evagination and eversion solely by changing the shapes of the cells. 

Although study of algae may provide clues, it is suggested mammalian embryology is more complex, e.g., requiring more complex molecular, intracellular and extracellular interactions over a much longer period of time.  

April 28, 2015

Toyota Out Front Again with Fuel Cell Cars

Toyota was the one that made hybrids acceptable in America.  They can probably do it again with hydrogen. 

Too bad the article is short on technology.  Is the hydrogen stored in a solid matrix or as a pressurized gas in a canister?  What are the details of the preferred technology for separating hydrogen from methane?

April 27, 2015

Patent Classes Flat Lining - Are We Running Out of Pioneering Inventions?

I have heard it many times, so it must be true - at the turn of the 20th century the Director of Patent Office suggested the Office be closed because there was nothing left to invent.  All the inventions were merely combinations of old stuff.  All the industrial machines were just the same old iron levers and wheels. 

This article suggests that we are again running out of pioneering classes of inventions, or at least that issued patents are weighing more heavily toward combinations of old elements.  Is this because we are less adventurous? ... more lazy? ... or in a universe with a limited number of fundamentals?

Maybe there are a finite number of fundamental technologies and once they are used up all new patents will be combinations from old classes.  This is not contradicted by the continued log growth of patent numbers while the number of invention classes has flat lined.  We have discovered light, and gravity, and smelting, and N-P junctions.  How much more is there out there that we have not detected with our technologically amplified senses?   

What other explanations are there be for the growth in new patent classes falling behind the growth of patents issued?   Patenting outside of marketability might be a factor.  Whereas patents used to focus on monopolizing a market, many patents are now pursued to impress investors with quantity, or to stuff a Scientist resume.  There is also a large group of first time inventors excited about patents (e.g., due to shows like Shark Tank) and thinking they have something in a combination, e.g., paint brush/can opener/flashlight. 

Still, it's not over 'til it's over, and it will never be over.  The article mentions biotechnology.  Look at some recent new classes - several totally different gene sequencing technologies, CRISPR, miRNAs, epigenetics ...

See the actual article at:

http://rsif.royalsocietypublishing.org/content/12/106/20150272

April 26, 2015

When Will Robots Draft Patent Applications?

I thought the article was going to be about software that drafted patent applications.  There are computers that write novels, and such, you know.  Maybe a computer could even draft a crude application based on a presented outline, and an Attorney could smooth out the rough edges.  But, it will be a long time before a computer can actually draft an application, much less proper claims.

Alas.  The software merely simplifies formatting and numbering tasks.  Claims and paragraph numbering, section formatting, insertion of literal claim support. 

I wouldn't exactly call this "automating the patent application process" but the software could save some time with original and updated application drafts.   

Over the years my law group has developed our own version of formatting and numbering tools using Word features, such as styles, document merging, and macros.  Still, if you don't want to develop these features, it might be nice to buy them premade.  Probably better than my system.  Not sure what it costs. 

See brief "demo" at:

https://turbopatent.patentnavigation.com/demos

April 24, 2015

Are Malaria Vaccine Final Data Disappointing?  

The article makes it sound like the vaccine was a disappointment.  However, the vaccine works across all forms of malaria; that is amazing.  Serious adverse events are reduced more than 30%. 

Some of the odd information in the article includes that even with boosters the incidence of malaria in vaccinated children did not go down as they got older.  Still, one would think lives would be saved because the greatest losses occur in the youngest children.

Odd too that the incidence of meningitis was much higher in vaccinated versus control children. 

Missing data includes incidence of mortality.  Did this save lives?

See Lancet publication at:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60721-8/abstract

April 22, 2015

Inventively Missing a Prior Art Reference

It seems strange from the viewpoint of a U.S. practitioner that any consideration is given, when evaluating novelty or obviousness, to how hard it would have been for one of skill in the art to have found a prior art reference. 

See the lines 75 to 79 discussion of the case at:   http://www.austlii.edu.au/au/cases/cth/APO/2015/14.html

To be relevant to inventive step (in Australia) a cited prior art document must be one that the relevantly skilled person would have ascertained (among other things).   I guess they consider a patent document not readily ascertained in a routine search less damning (less obvious). 

I remember a case hurt late in prosecution because neither we, nor the Examiner, were using the right search terms.  Everyone was searching "eye glasses".  Much later, someone thought to search "spectacles" and found a reference devastating to our claims.  I guess in Australia, the claims may still have been considered inventive because we had trouble finding the reference. 

Novelty is a matter of fact.  Either the invention was previously documented or not.  The same should be true for Inventive Step (obviousness) analysis.  GIVEN the prior art that exists, would it be obvious to use of combine as in the claim.  Is it inventive to miss prior art reference in a routine search?

April 21, 2015

Even With Money EPO Examiners Not Happy 

I had always thought the quality, succinctness, and cooperation of EPO examiners was above the rest. However, I had also noticed lately a little less cooperation and less reasonableness. Maybe they are getting crotchety, even if well paid. Sounds like a management problem. 

April 20, 2015

Ford 11-Speed Tranny 

Got to love planetary gears, but this is over the top.  After 10 gears isn't that really a CVT?

See patent app at: 

http://www.autoguide.com/blog/wp-content/uploads/2015/04/Ford-11-speed-transmission-patent.pdf

April 19, 2015

BHT.  Another Magic Bitter Pill

When you starve or over exercise, blood glucose can go low, glycogen sources can be depleted.  With the body running mostly off of fat, many ketones and organic acids result in the metabolism of fatty acids.  Ketoacidosis results. 

Still, the brain can continue to run on certain ketones, such as β-hydroxybutyrate (BHT). 

Apparently there is a whole system, I never heard of, called the inflammasomes. sounds like a vesicle, but they are protein complexes assembled in a variety of different ways, e.g., depending on the source of irritation (virus, nucleic acids, asbestos, TNF).  Geez, I do not have time to memorize all the acronyms:

http://www.invivogen.com/review-inflammasome  

Anyway, the article below says BHT interferes with inflammasomes (e.g., reducing Alzheimer's - is this why exercise is the best way to prevent congantive impairment?). 

AND, BHT can help one lose weight, not just being a product of losing weight. 

April 16, 2015

PTO Does Not Know (and Doesn't Want to Know?) When Examiners are Doing Bad Work

We don't want to go back to the bad old days when all Examiners were afraid to allow a patent, for fear the review panel would find an error in their work (with no such review for non-allowances). 

The article touches on the weak hand of supervisors, but drops the ball.  I have run across maybe three really incompetent or lazy Examiners in my career, apparently intentionally obstructing prosecution of cases.  They were so outrageous in their rejections that I had to go over their head to their SPE (supervisor).  Each time, the SPE agreed with my comments about the errors in the Examiner's work.  What really struck me though was the SPE seemed afraid to confront the Examiner with the facts for their bad work.  I always wondered why.  Does anyone know?  Anyway, I would go further over the SPE's head to a QC Specialist, and usually got some productive action (although in two cases the Examiner was not reassigned, hated me, and continued obstructionist behaviors). 

I see three big chances for the PTO to improve Examiner performance.  1) Stop rewarding volume and rejections.  2) Give SPEs a freer hand in disciplining Examiners (are these guys Unionized?).  3) Do a thorough prosecution history review of cases where the Examiner loses an Appeal or Decision in a Request for PreAppeal Review.

----------

I have received comments from an anonymous previous Examiner suggesting that the SPEs are not innocent and that SPEs intentionally turn a blind eye to lame rejections.  Some even "demand new examiners reject all claims in every application no matter how 'bogus' the rejection is."

What is the motive for this?  Less work?  It is easy to reject all claims, especially on the first Office Action.  No one reviews this.  Allowances are more visible.   

Sometimes there is a reasonable rejection of independent claim, but the dependent claims appear allowable in light of prior art on the record.  Maybe, the SPE and Examiner are too lazy to search further and make the additional arguments, but have a "gut feeling" the dependent claims shouldn't be allowable either.  Patent prosecution is complex, and it can be difficult to do all the searches and make all the arguments on a tight time line (PTO quota system).  

In a completely opposite strategy, I have seen Examiners throw in every possible rejection (valid or not) including all rejection rationales.  30 page Office Actions, in a battle of attrition hoping to discourage the Applicant into abandoning the case; while the Examiner gets credits for "disposing" the case. 

I must note that in general, most Examiners do a good job, but the problem ones make for more interesting conversation.  

April 14, 2015

Bacteria Can Have Autoimmune Disease

This is great.  Bacteria can have autoimmune disease wherein they attack their own genome. 

The CRISPR system only memorizes foreign sequences that are being replicated rapidly and which do not contain abundant Chi sites (common in the bacteria, but not the phage).   

I was going to comment that it might be a good strategy for the phage to add some Chi sites (about 8 bases).  Was surprised to find that Chi sites were originally found in lambda phage.

April 12, 2015

Triplet Code Dogma Amazingly Shattered

It is old news that some microorganisms have mutations (amber, ochre, opal) that allow read through of stop codons.  So, it should not be surprising that, out of all life forms, some read animo acids into a "stop" codon, as a matter of course. 

Life is flexible.  I have done a lot of work on engineered organisms that incorporate unnatural (not of "the" 20) amino acid at a stop codon instruction.  Heck, you only need one stop codon, and they have two extras. 

The biggest surprise for me was that such "reassignments" were found in eukaryotes, but not Archaea. 

April 10, 2015

New Antibodies in the Mutation Race Against HIV 

The race is on.  While the human immune system is undergoing affinity maturation to strongly target the HIV antigen, the HIV is mutating to avoid the ever stronger antibodies.  The article says:

"Broadly neutralizing antibodies are produced naturally in some 10 to 30 percent of people with HIV, but only after several years of infection. By that time the virus in their bodies has typically evolved to escape even these powerful antibodies."

Why don't these broadly evasive evolved HIV become the norm more generally?  Maybe difficult antigens low in stimulation and slow to prompt the high affinity antibody.  Anyway, no cure.  300x HIV reduction of HIV is not dramatic. 

But these are great clues.  Further, these antibodies may provide another ingredient in the ever improving treatment cocktail combinations.   

See the NBC fluff piece at:

http://www.nbcnews.com/health/health-news/magic-bullet-antibody-can-suppress-aids-virus-n338066

April 9, 2015

Patent Filing Costs

This is a good review of patent costs. 

My practice differs a little on the searches compared to the discussion in the article.    Most of my clients are experts in their fields (PhD researchers) and are very familiar with the state of the art.  We are hardly ever asked to do a search.   

For relatively simple inventions, e.g., consumer products, I usually do a quick search on my own.  There have been several times a client said he has "never seen anything like it", and I found it right away with a Google search, saving them thousands of dollars.

Although we rarely have a search done, it has been extremely rare that we were caught totally by surprise by devastating spot on prior art during prosecution.  There was the time even the Examiner didn't find the devastating art 'til way down the line.  Big waste of money, but rare. 

Another major difference in my experience is in the cost converting a Provisional application to U.S. Utility application.  Typically, in my practice, the cost of conversion is very low.  We typically draft Provisional applications and claims so formal that there are no significant changes required to file directly as a Utility application, unless the Applicant has new matter to be added.  

Then, there are foreign filing costs ...

April 7, 2015

Contortions in Applications Attempting to Include EPO Claim Amendment Support

I just filed a 150 page patent application yesterday with the intention to prosecute in at least the U.S. and Europe.  Last year, I filed the Provisional application with Europe in mind.  The inventions involve a generic DNA assay with claims to compositions and methods with many specific examples.  I described the assay generically and specifically in a way that would provide adequate support in the U.S. (e.g., with a genus paragraph followed with paragraphs with specific variants of each limitation aspect).  Then, for the Europeans, I included paragraphs systematically listing combinations and permutations of all species of each claim element with every other species of other elements.   

When the 12-month date rolled around for formal filing, I worked with a European patent attorney and further enhanced the ability of the application to meet the strict added subject matter rules for claim amendment in Europe.   

Under Art. 123(2), it is impermissible to add to a European application subject-matter which is not directly and unambiguously derivable from the disclosure of the invention as filed, also taking into account any features implicit to a person skilled in the art in what is expressly mentioned in the document.

http://www.epo.org/law-practice/legal-texts/html/guidelines/e/h_iv_2_3.htm

1. We started by adding statements that the examples can be used alone or in combination (probably does no good). 

2.  We expanded comprehensive descriptions of practiced embodiments and embodiments expected to be marketed.  The descriptions were in Single Paragraphs, with favored alternates.  It seems (absurdly) that the EPO deems the exact same text broken into two paragraphs no longer shows One of Skill in the Art the applicant envisioned the whole concept that was in one paragraph.   

3. For each independent claim, we put a paragraph in the Summary of the Invention generically describing the invention and listing alternatives (Markush lists) of each claim limitation.  For some reason, the EU attorney suggested such paragraphs provide better claim amendment in the SoI than in the Examples section (anybody?).

4. We took the entire claim set of 150 claims and added it to the end of the application with paragraph numbers.  No one can say we did not have support for the original claims.  Further, we will be filing a Preliminary Amendment removing most of the claims to avoid excess claims fees in most countries (e.g., if we go into China, the PA will not avoid the excess claim fee).

A lot of this seems crazy to me.  If I describe a generic concept with five elements, and describe variants of each element, and I affirm that the alternates of each element will work with the variants of the other elements, it seems unreasonable to suggest I didn't describe the combinations.  This is worse yet, when One of Skill would actually be confident that the alternates would indeed function in certain combinations (proposed in amendments).    

The European rules literally seem reasonable, but enforcement is perverse.  For example, For example, if I describe a generic apple with a size and a color. Then I list large, medium, and small in a paragraph outlining sizes; and red, yellow, and green in a paragraph outlining colors, the EPO WOULD NOT FIND SUPPORT FOR A LARGE RED APPLE!

So, because the EPO rules are soooo unreasonable, we had to address them with a silly and unattractive witch's brew of redundant contortions to convince the EPO we know what everyone reasonable already knows we know - No?  Are "features implicit to a person skilled in the art" different in the U.S. because Americans are smarter?  OK, emoticon time:   ;- )

Seems a few months ago I was reading that the EPO may be loosening interpretation of these rules in favor of Applicant claim amendment support.  What ever came of that? 

April 3, 2015

Improved Trisomy 21 Detection from Blood Sample

I am not sure what is the "standard" method of trisomy 21 detection compared to the cfDNA technique of the article. 

I remember working as a Med Tech years ago and the technique was to stain and photograph the chromosomes of the fetus from an amniocentesis sample.  We actually shot a Polaroid instant photo and used scissors to cut out the image of each chromosome.  Then, we lined them up according to size, shape, and bar patterns into pairs on a paper chare.  If you came up with three chromosome 21 copies, voila - trisomy 21!

I suppose this is still the standard confirmation, using digital equipment.   

I assume the cfDNA technique is some kind of quantitative PCR.

April 1, 2015

Quick Assay for Apoptosis Protein Distinguishes Viral from Bacterial Infections 

TNF-related apoptosis-inducing ligand (TRAIL), is a protein functioning as a ligand that induces the process of cell death called apoptosis.

See patent at:

https://www.google.com/patents/WO2013117746A1?cl=en&dq=WO+2013117746&hl=en&sa=X&ei=3RcYVaaREsT2oASvuoGQBg&ved=0CB4Q6AEwAA   

This is very important work.  If we could exclude half the instances where antibiotics are prescribed for viruses, that would be monumental.  Still, there would remain the issues of secondary bacterial infections, and prescribing the wrong antibiotic even when the infection is bacterial. 

March Entries:

March 31, 2015 

Scientists Joust Over Shrinking Ebola Study Territory

It has been a problem with Ebola that clinical studies can only take place during an epidemic. 

Clinical studies in West Africa are ongoing for the  tobacco antibody and an iRNA.  One group is concerned that "the likelihood of catching Ebola is only big enough in the area around Conakry", the Guinea capital.  Another that they "hear rumors that NIH have reached an agreement with the Sierra Leone government to conduct the ZMapp trial in any Ebola treatment unit ...If this is correct, it will jeopardize ongoing trials and lead to conflict" with the TKM-Ebola study. 

It may be good news for now that the territories for Ebola clinical studies are shrinking.  At least there will be more drug and vaccine candidates available up front next it pops its head up. 

March 30, 2015

"Bionic Eye" has Finally Been Tested in Patient 16 Years After Priority Date  

Priority Date of 1999 for this technology.  Will they be making money before the patent expires?

See a copy of the patented invention:

https://www.google.com/search?tbm=pts&hl=en&q=7668599

The "bionic eye" is a photodiode array and the processor sends signals past the patient's damaged retina to the still functional optic nerve.  Sounds like pretty difficult micro surgery.

The patient can then see general shapes of doorways, and such.  I assume the patient's brain would get used to it and gradually provide even greater resolutions and interpretations of the signals. 

Step one.  Are some pioneering inventions worth anything?

March 28, 2015

If You Use IPR to Manipulate, Use Due Diligence

Clearly, it is against the law you arrange a short sale of a stock, then disseminate false rumors, to make a profit on the sale.  So, at a minimum, such practitioners must document due diligence in confirming the truth of their statements to the public.  If they lose the IPR (not statistically likely, lately), this might be used as evidence the public statement was false. 

It still seems unfair to buy stock short and then initiate even a well founded Inter Partes Review (IPR).  But it is hard to make a case of insider trading on non-public information.  I suppose the questionable validity of the stock's patents might be considered public (obtainable) information.  And, stock traders are not subject to "insider" trading rules if the information did not originate from within the business of the stock issuer. 

But is still seems an unfair advantage over the market when the short buyer manipulates the market and controls the timing of the IPR filing.  The stock involved can easily go down 5%, and profits can be huge if the short seller is using leveraged transactions.  The money comes from other blindsided stock holders.   

Hey, all you lawyers out there, give me some theories on what causes of action could be presented against these IPR filing short sellers - intentional infliction of emotional distress?

March 27, 2015

NewBridge - Place Name TM Allowed If No One Ever Heard of It

This is particularly true if the type of product is not a major industry of the town place, or if the maker is not actually in the place. 

Don't try to trademark "Venice" blown glass made in Venice. 

March 26, 2015

Fed Circuit Case May Expand Preamble Terms Held to be Limiting

Here is another case that reiterates that one should not describe what is "the" invention in the specification.  The case also seems to place far more preamble phrases into limiting terms of the claim. 

The preamble, which recited a "repetitive motion pacing system for pacing a user," was deemed limiting because it provided antecedent basis for terms appearing in the body of the claim.  Because "a user" was in the preamble before "the user" in the claim body, the preamble terms were held limiting.  This case seems to modify the previous case law (e.g., Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305) in identifying any preamble with an antecedent term to be limiting.  Maybe we should all start our claims with "a device comprising:"

The article states "practitioners should be careful about using the phrases 'present invention' or 'principal object' of the invention in the specification.  As the Federal Circuit in Pacing Technologies found, such statements may serve to limit the claims even when the plain and ordinary meaning of claim terms connotes a broader meaning.  Indeed, as the Federal Circuit noted, if a disclaimer is found based on such statements in the specification, the disclaimer may be enforced even if it excludes an embodiment described elsewhere in the specification."  This is pretty much old news.  However I find they missed a key point - "the" invention.  I usually discuss "an aspect" or the "invention, or the invention includes, e.g., "  Never just flat out say what "the invention is".

March 25, 2015

Obviousness - My Favorite Subject (Mixing Paint is Way Different From Mixing Grout)

I am constantly using the argument that a combination of references is not obvious because the combination requires the primary reference change its principle of operation (In re Ratti, 270 F.2d 810, 123 USPQ 349), or require the structure incorporated from the secondary reference to function differently in the combination than the original reference (KSR or  Sundance v DelMonte, 550 F.3d 1356).  Also see MPEP § 2143.01. 

I can usually succeed with these arguments against an Office Action, if not on Appeal.  These controlling cases do NOT require that the combination changes a principle of operation that was essential to the inventiveness of the cited prior art.  However, this fact would apparently be strengthen the fact based arguments. 

The "intended purpose" argument seems like a variant of European problem/solution, or even KSR rationales, that structures have to retain function in the combination.  What is interesting about this case is that Examiners often argue that the incorporated element has some broadly generic function that covers the claim.  Here, such a rejection rationale was not good enough.  The PTAB found it non-obvious because the combined element didn't address the more specific intended purpose (not obvious to apply paint in a technique that before applied calking).  

Interesting cases - too bad not precedential. 

March 24, 2015

Tetracyclene Toxic to All Life Forms - Damages Mitochondrial Protein Translation 

This is pretty dramatic.  Tetracycline is a broad spectrum bacterostatic antibiotic that blocks protein translation by blocking attachment of charged tRNAs to the ribosome.  Mitochondria are believed to be Archaebacteria that provided energy to early eukaryotic cells.  Amazing the RNA structures blocked by tetracyclines have been so conserved over the hundreds of millions of years, apparently across all life forms.

It has been known for a half century that tetracycline harms the metabolism of mitochondria.  Many functional protein complexes in mitochondria include both proteins translated in the mitochondria, from mitochondrial DNA and proteins translated and  imported from the cell nucleus.  If mitochondrial proteins are not manufactured adequately, there is an imbalance with imported proteins so that functional complexes are not assembled. 

The article makes it clear that tetracycline and tet-on/tet-off expression systems can be a very bad choice, particularly for studies of cell metabolism.  Worse yet for the public in general is the huge amount of tetracycline fed to animals intended for consumption.  

March 23, 2015

Patent Professionals Must Guarantee the Quality of Documents They File

This kind of client instruction, requiring Counsel to file poorly written documents without modification, is one reason why our firm has received far fewer new cases from certain educational institutions in recent years.  They required us to simply file "quick and dirty" versions of their soon to be published journal articles.  We have had to refuse such work.  A journal article is not a patent application.  Modified journal articles often make good Examples at the end of an application.  However, in order to receive proper claim scope, and to avoid predictable written description and enablement issues, the specification must be designed with Office Actions in mind.  

If nothing else, the client must allow the Attorney to read the document and point out problems that should be addressed.  Sometimes the Attorney can at least delete a statement that may be construed as an admission of obviousness, or broaden out a statement of what the invention "is".   

In the case discussed, I don't see disbarment, or suspension as the worst penalty.  How embarrassing to be dressed down in public by the Supreme Court!

March 21, 2015

Abuse of the PTAB to Make Money Shorting Stock

Depending on the PTAB outcome, the stocks may come back to where they would have been, however, by that time the short sellers and hedge funds have already sold out. 

I wonder why the following issue was not discussed? - If you have material non-public insider information (knowing the fact you will start third party review of a patent), it is illegal to trade on the stock.   I guess the insider must be a person associated with the corporation that issued the stock.  Still, it seems they may be transgressing a statute or ethical behavbior with what appears to be kind of a reverse "pump and dump".

March 20, 2015

Drugs from Federal Financed Research Do Not Reach Market without Patent Protection

Here are some data that starkly demonstrate the value of patent "monopolies". 

"Prior to the passage of the act [Bayh-Dole - allowing Universities to license out inventions], no drugs had apparently been commercialized based on the results of the government R&D spending.  Subsequently over 183 drugs have been developed", once the Bayh-Dole act allowed technology transfer. 

Some argue that patent rights provide no net benefit to society.  This is strong evidence that they do.

Some argue that the research was with public funds and should be placed in the public domain.  However, note that the public did not benefit from the previous inventive drugs without patent protection.  Further the public is paid back many ways - jobs, motivation for more drugs, and money back to the education system.

March 19, 2015

More Stable Second Generation Formulations are Obvious in India  

Section 3(d) of the patent act prohibits grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance.  In this context "enhanced efficacy" apparently means enhanced therapeutic effect.  They say just because you find a new more stable formulation by trial and error, this does not mean the new formulation is inventive.  However, if the formulation is not a drug, such improvements are inventive.  Hmmm. 

Even if India had not withdrawn the issued patent to the more stable tiotropium formulation, no one can make the drug until its original patent expires.  There is no "evergreening" because when the old patent expires anyone can practice it.  The only difference is that now anyone can also practice the more stable formulation.  But this right is traded off for the reduced motivation to discover such formulations and to practice them in India.

I believe the new formulation is inventive, e.g., because it is not obvious.  If it was not inventive, why didn't Boehringer use it as the original formulation?  And since when is the unexpected result of trial and error experimentation not inventive.  I worked in Formulations and Stability in large pharma for many years, and I can tell you formulation improvements are not obvious.

It seems the India Patent Office has set up a separate standard of inventiveness for drug formulations for political, not scientific, reasons. 

March 18, 2015

Young Man - Terminate Your Copyright Transfer

Like co-inventors (joint ownership), co-copyright holders have independent (separate) rights. 

Certain artists that gave up their rights after 1978 are eligible to terminate the transfer after 35 years.  See:  http://www.copyright.gov/docs/203.html

Here, Victor Willis (Village People Cop) seems about to have his 50% interest in several songs returned.    

March 17, 2015

Slow Browning Apples Proud to be GMO - Patented and Now FDA Licensed

The second FDA licensed GMO fruit is out.  Arctic®Apples have an RNAi that suppresses polyphenol oxidase (PPO) enzymes that cause browning in cut or bruised fluit. 

CSIRO uses the ARTIC trademark to label the apples, e.g., Arctic®Fuji as GMO in the market place. 

CSIRO has apparently licensed the PPO sequences.  I am not sure why.  The PPO sequences are not cloned into the apple products.  In fact, the Artic apples suppress the PPO genes and I wonder why CSIRO did not just delete the PPO genes, or at least the most browning inducing isotypes.  Like many genes, there are multiple functions (beyond browning of fruit) that may make deletion deleterious or lethal.  Anyway, CSIRO went the route of RNAi (RNA interference with complementary mRNA target) to inhibit the enzymes. 

Maybe CSIRO licensed the PPO genes to avoid law suits around the use of the genes in the design of the particular associated RNAi sequences.  Of course the issue of PPO gene patent claim validity (35 USC 101 subject matter eligibility) has to be mentioned here.  If the PPO gene patents include only natural sequences the claims may be invalid.  However, I suspect the RNAi sequences are directed to cDNA (mRNA) sequences found eligible for patenting by the Supreme Court in Myriad (unless, e.g., the sequence does not bridge an exon?). 

Cool article - patents, trademarks, licensing, GMOs, you name it. 

See PPO gene patent at:

https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US6936748.pdf   

See RNAi patent at:

https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US8563805.pdf 

March 16, 2015

Requirement to Report All Clinical Study Data Mostly Ignored

Scientists know that negative results are often more valuable than positive results.  Some of the greatest scientific breakthrough of all time were based on negative results.  If the haldron collider had not found the Higgs boson, that would have been as monumental as finding it.

I see that FDAAA 801 establishes penalties for responsible parties who fail to comply with clinical study summary release. These penalties include civil monetary penalties (up to $10,000/day), and for federally funded studies, the withholding of grant funds.

See UCSF PowerPoint at:   http://health.usf.edu/NR/rdonlyres/06665185-29B7-47EA-A42A-02D49C038167/44956/ClinicalTrialsgov2813.pdf

Apparently, as with many other laws on the books, there is a lack of enforcement.  Clearly this is the reason for universal lack of compliance. 

March 15, 2015

PTO is Serious (Again) About Enhancing Quality of Prosecution

Feeew.  Scared me.  Last time the PTO was concerned about "Quality" they thought it meant not issuing any patents for fear a "false positive" allowance might occur.  I remember an Associate Director gave a talk back in those days at a "PTO comes to the Bay Area" conference.  He went on and on about quality.  See how the false positives are down.  I got to the microphone and asked him how the false negative (rejections of valid claims) was going.  He made some funny sounds and didn't have an answer that made any sense.   

See the new Quality Initiative Request at:

https://www.federalregister.gov/articles/2015/02/05/2015-02398/request-for-comments-on-enhancing-patent-quality

The Six Quality Proposals (my comments):

Proposal 1.   Requests for quality review in a particularly bad Office Action.  Applicant who receives a very low quality office action would be able to seek review in this more informal manner without appeal or RCE.  Currently, I use Request for a PreAppeal Review Conference.  Just today I got a Decision in my favor.  Usually embarrasses the Examiner into being more cooperative.  But, wouldn't it be great when you get a totally ridiculous Office Action if you could just have someone with power, and no skin in the game, give a reality check (without making the Examiner mad)?  It would be worth a lot if Examiners had to worry early about being embarrassed by bad or lazy work. 

2.  Seems a combination of an automated search and the best (of the few IDS references;) would be a good starting place for pre-examination review. 

3.  Thank God, some years ago the PTO finally made available OCR .pdf copies of the files.  Still, I have to do major review and editing if I want to quote the Examiner, or get a copy of the claims for a case just transferred in (anyone ever have a client who could not find a copy of their specification or claims?).  Yes, .xml files would be nice.

4.  The PTO motivation system and Examiner performance are intertwined.  The Examiners are mostly focused on how to please the PTO and earn their motivating points, often to the detriment of fairness and the quality or expense of the patent.  Things are better than the bad old days when Examiners were extremely frightened of allowing a case, for fear they missed a detail and made a dreaded "false positive" allowance that could ruin their career.  Still, I routinely receive Office Actions with all claims rejected, with some claims actually having no rational reason on the record for non-allowance.  Why can't they just allow a narrow dependent claim now and then, if it is not arguably obvious?  /span>

5.  I have stopped using RCEs, and have filed more Appeals (including Requests for PreAppeal Review - PARC) in the last 2 years than the previous 10 years.  I set things up in the first Response, and when I am right, I am right.  Time to Appeal.  It is good that the PTO now facilitates negotiations in the After Final Pilot Program where Examiners get credit for entering agreed amendments after final. 

There is one thing about the Pre-Appeal Review program that should be fixed - The Decision says nothing.  If there were three issues and the Review Committee agreed with Applicant on two of the issues, all the Decision says is "there is at least one issue remaining for Appeal".  So, I only use PARC for cases where there are only 1 or 2 simple issues to be addressed. 

6.  I am pretty convincing over the phone.  Still, I am sure person to person would be effective and I look forward to Interviewing with Examiners here in the Bay Area, once the opportunity comes to fruition. 

March 14, 2015

Clueless About Risk/Benefit Ratios 

Wow, talk about lack of informed consent.  Are your client/inventors clueless too?

This meta-analysis finds a patients are almost never well informed about the risks and benefits of procedures and drugs. 

http://archinte.jamanetwork.com/article.aspx?articleid=2038981

I don't know what can be done.  People are hopeful and only hear what they want to hear.  I see this all the time in my patent practice.  At the outset, I tell the clients about all the costs and delays inherent in patent prosecution, then they wonder why their case is not issued at low cost in 18 months. 

It is worse in medicine.  At least most people have a clue about time and money.  Try to explain to a plumber about his pancreas. 

The best we can hope for is a benevolent dictatorship.  Well informed doctors with all the information, prompting us toward the best decision.  Problem is, I have seen doctors biased for me to have a surgery with no net benefit (setting broken clavicle with metal plate) just because I was insured. 

On the positive side, maybe "precision medicine" can change some of the risk/benefit ratios for the better in the future.  As a patent practitioner, I try to keep up to date on patent allowance trends, generally and in my office, so I can answer the question - "What are the odds this case will be granted?"

March 13, 2015

They Say We Actually Get the Flue Only Every 5 Years. 

Personally, I don't remember getting the flu more than a few times in my life.  Probably, I have been sub-clinical a lot of times.  About once every 2 years sounds as I expected for kids. 

I am not sure how this study could have worked.  They used the word "assumed" a lot, but they must be right, because they used calculus.  I did wonder about how they resolved whether the antibody titer against a strain was due to an actual infection and a vaccination.  Because immune responses from actual infection are stronger, and to a larger variety of antigens, it could have been possible to determine whether titers were from vaccination or illness.  This, particularly if vaccination records were available.  However, at one point, they did mention "note that we do not distinguish between live infection and vaccination in the model." 

See the journal article, here: 

http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1002082  

I wonder if the frequency of infection eventually goes back up with age?  I wonder if people with kids get the flu more than every 5 years?  

--------------

You are Not in Control of Your Drug Licensing Path

A lot of new drug candidates are not identified by understanding some brilliant relationship of structure and function.  Many drugs are discovered by accident (e.g., penicillin).  So keep your eyes open. 

There are usually some animal studies before the human Phase I study.  If  the drug works in animals, they test safety with low doses in human volunteers (Phase I).  Now you have spent a lot of money and usually have no data on whether the drug works or has significant side effects at effective doses in humans. 

Sometimes clinical studies do not go well.  If the FIRST Phase III study suggests a different end point than the design, or if the database is not large enough to confirm statistical significance of an end point (see Cetus' IL-2, Proleukin) you might elect to go on to a second Phase III study.

Not an easy path.     

March 12, 2015

Colors Prefiltered Before They Arrive at Cones and Rods

Apparently color vision does not depend just no the absorbance frequencies of the cone cell pigments.  This article suggests there is some prefiltering by the layer of tissue in front of the light sensitive cones and rods in the retina. 

Still, I have a little trouble with the article.  They discuss "light guides" and "piping" suggestive optic fibers.  However, light pipes work on the principle of reflection (from the inner walls of the pipe).  This looks more like a diffraction phenomenon to me, e.g., more like a grating. 

What do you think?

New Era - NYT Says Most Brand-Name Drugs Eventually Lose Their Patent Protection; First Biosimilar Licensed

Amgen used to be the only maker of granulocyte  colony stimulating factor (G-CSF, under the name  Neupogen.  A synthetic DNA sequence encoding human G-CSF was expressed in the bacteria E. coli (OMG No, a GMO!) and purified as a drug to treat certain cancers.   

Now, the FDA has licensed a similar product, probably manufactured at a lower cost (low R&D and more efficient modern manufacturing processes) to be sold by the Novatis subsidiary Sandoz. 

March 11, 2015

Federal Judge Says Dentist Has "Unclean Hands" (In Equity)

More On the Dentist Who Forbade Negative Reviews and Claimed Copyright to Reviews

The Dentist really hated bad reviews.  Tough business.  Probably got bad review for a reason.

The Dentist's "contract" apparently included fines for bad reviews.  To fight the reviews he fined his patients and claimed copyright to the reviews.   

The Fed Judge found against the dentist based on first amendment commentary and "unclean hands" for the Dentist bad acts in equity. 

Imagine being a dentist labeled by a Federal Judge as having unclean hands.  Gross.  The Dentist has disappeared and there is no expectation the patient will collect his 45000 or that the dentist will ever practice in the U.S. again, under his real name.  

March 10, 2015

Newest Estimate of the Average Cost of Bringing One Drug to the Market $2.6 B

Finally an estimate that includes all the costs, especially the costs of failures and R&D.  OK, and another cost non-economists do not understand - the opportunity cost (money investors would have made in another investment over the years it took to make it to market; not just the money back they put in).  Anyone wanting free drugs likes to ignore these costs.

Good news is that the cost of IP protection is only 1% of the development cost.  We are a bargain. 

And, of those drugs making it to market, only 20% ultimately make more than the average $2.6 billion to get their money back.  In those 20% are blockbusters that earn back 10x the investment.  In that 80% are a lot of failed projects in big companies, and small companies crashing when their clinical data does not match the animal models. 

So, if governments around the world want to pay a "fair" price for successful drugs, they should also pay a premium over the present cost to manufacture the successful drug. 

March 9, 2015

Indian Formulations Taste Better - Not a Trade secret Any More

No wonder every old Indian mother has a trade secret masala formulation.  "What is the recipe for this great curry?"  - A little of this and that and masala.  "What masala?"  My masala.  "What are the ingredients of your masala?"  I can't tell you.

 Now "science" has figured out the main secret to a good Indian dish.  The spices all have different flavor ingredients.  Cardamom is different from cinnamon, from mustard, from garlic.  None of this black pepper, red pepper stuff.. 

----

Ok Yeah, a big mistake in the article - chicken tikka-masala is not Indian (English) and tends to taste more like Spaghetti-Os.

March 8, 2015

Rockets - What Good are Method Claims With Steps You Can't Practice Within One Country? 

Funny thing about spacecraft methods, even if you make the rocket in Russia and have a patent there, all you have to do is practice the actual method somewhere else. 

In fact, the spaceship landing is on a barge, out in the ocean -international waters without any patent enforcement jurisdiction.  Too bad they did not file in Vanuatu. 

 March 7, 2015

Mustaches Popular at the PTO During Mustache Week

Some of those mustache trademarks look pretty similar.  Good thing they are not in the same international class. 

I had a beard and mustache for 15 years.  Started when I went on a long trip and did not want to have to shave every day.  When I finally shaved it off (working in pharma manufacturing, it was inconvenient), my little daughter did not even recognize me.

Mustaches have gone from about 50% of men in the 1870 to only about 10%.  The real looser seems to be sideburns.  See:

http://www.vox.com/2015/3/1/8123457/beard-history-chart

March 6, 2015

Why, Why, Are Men the Way They Are?

Another good example of how biased population sampling can lead to the result one wants to dramatize.  You think this study of XYY men was good, maybe someone should do a non-biased study of XXX women in a population of exotic dancers.   

I suspect this is another example of non-scientists (non-statisticians) carelessly (or intentionally) sensationalizing a "human interest" story to up readership.  Not that there is anything wrong with that.

March 5, 2015

Of Rats, Fleas, Lice, Gerbils, and Other Cute Disease Carrying Creatures

There has been a lot of press lately about the fact that waves of the black death plague - Yersinia pestis) in Europe corresponded with peaks in giant gerbils in Asia. See - http://www.npr.org/2015/02/28/389595442/rats-blamed-for-bubonic-plague-but-gerbils-may-be-the-real-villains   

Some of the press misunderstood and assumed that the Asian gerbils were directly infesting Europeans with fleas.  However, I believe the population of gerbils and their fleas in Asia went up, causing an increase in plague in Asia.  Then, caravans from Asia reseeded the plague in Europe.  

Note, it the cute little prairie dogs that carry plague now days in America. 

Anyway, this article is correct that the black rats infested the Europeans with the fleas, once the disease was passed in from the Asian gerbils.  Wow, this is the first time in almost 100 years that a survey of rat body insects has been completed.  I would have though some undergrad would have had the privilege at least once a year!

March 4, 2015

How Do You Promote Effective Early Communications with Potential Clients?

1.  How many potential clients have left a long clear message, then rattled off their phone number like an indecipherable machine gun?  My answering machine says - "If you want me to call you back, please say your phone number slowly and clearly."

2.  Small clients often want their patent services local.  However, I explain to them that I don't actually see most of my clients during the prosecution of their patents.  My first patent was for oil drilling equipment invented by a couple living in Australia, whom I never saw.  With modern (inexpensive) communications, face to face is not absolutely necessary (if not as efficient).

3.  There is nothing riskier than giving an opinion.  I will only give them with all the realistic liability reducing caveats.  This can never be done in a rush, particularly without all the information.  And,... it doesn't hurt to get paid for it.

4.  Many small clients are so uninitiated that I actually enjoy the free consultation because the time is so valuable to the potential client.  Arranging a consultation with the client, I systematically list the materials and information that would be most useful in evaluating their case.  With all the information, it is much easier to make an estimation of what their costs will be to the point of filing an application. 

March 3, 2015

It's a Suture, It's a Glue, It's Super Clot 

At first I thought this stuff was superglue (methyl 2-cyanoacrylate,)  and I wasn't too far wrong. 

The technique calls for n-butyl-2-cyanoacrylate (previously sued as an instant glue suture for wound closures) to be injected from a catheter directly into a varicose vein.  The glue can not travel far because it rapidly polymerizes in the presence of water.  Even though it looks like two poisons (cyano  acrylate), it is apparently safely biodegradable. 

I assume the veins shrink and fibrose before the glue biodegrades, leaving slender beautiful legs.   

March 2, 2015

If You Can Not Patent the Old, Make It New By Putting It in a Truck

A patent on delivering products by printing them on a truck near your house.  

Am I dreaming?  The first claim (see hyperlink to patent application, below) is to "A computer-implemented method".  Are they asking for an ineligible subject matter rejection?

See patent at:

http://regmedia.co.uk/2015/02/25/amazon3dpatent.pdf

Can this not be obvious based on the prior art?  Of course, the claims will be narrowed, if they make it past parent eligibility requirements. 

March 1, 2015

Boeing Patents Aspect of Multiple Lift Carrier Satellite Launcher

The patent is not actually claiming a four stage launch system.  Here are the claims of the patent issued:

U.S. 8,955,791

1. A vehicle comprising: a first stage aircraft; a second stage aircraft; and an interstage coupler for coupling a nose section of the first stage aircraft to an aft portion of the second stage aircraft's fuselage prior to in-flight separation, and for decoupling the first and second stage aircraft to initiate in-flight separation, wherein the interstage coupler includes a plurality of retractable arms spaced about a perimeter of a nose section of the first stage aircraft, first ends of the arms hinged to the nose section, and second ends of the arms securable to the aft portion of the second stage aircraft.  

The "patented vehicle" does not actually include a four stage system.  There are a lot of two stage (jet with rocket) or three stage systems that have been conceived.  All that aside, I still think the overall concept of multiple specialized lift vehicles is a good one, if unpatentable (e.g., obvious). 

February 28, 2015

For a Half a Billion Dollars, Couldn't They Just Deem the Software Claims Patent Ineligible?  

I don't hear anyone shouting invalidity. 

I'm sooo smart (how smart am I?) that I could carry out all those claim steps in my head.  Therefore, I deem the claim ineligible subject matter!

See claims at:

http://www.google.com/patents/US7334720

February 27, 2015

Short DNA Comes Up Short in Patent Eligibility 

Certain claims at issue in the original Myriad case were "15-mer" sections of the BRCA sequence.  Such claims have been found not to be patent eligible subject matter, particularly since being "isolated" no longer cut it.

Another problem, though, with short sequences is that they are not new.  Apparently, there were thousands of sequences throughout human and other animal chromosomes that have at least a 15 base sequence also found somewhere in BRCA.  So, even if the 15-mer were patent eligible, there would still be the issue of (inherent?) anticipation or obviousness.  It is hard to patent short DNA sequences without "something more" than isolation, or unattached 5'/3' ends. 

February 26, 2015

If You Can Not Patent the Old, Make It New By Putting It in a Truck

A patent on delivering products by printing them on a truck near your house. 

Am I dreaming?  The first claim (see hyperlink to patent application, below) is to "A computer-implemented method".  Are they asking for an ineligible subject matter rejection?

http://regmedia.co.uk/2015/02/25/amazon3dpatent.pdf

February 25, 2015

California Wants to Determine if Drug Cost is Reasonable

The one cost they left out in their "transparent" evaluation of why drugs are expensive is the cost of the nine other drug candidates that failed, but have to be paid for by the successful drug. 

What goes 'round comes 'round.  Maybe someone should see if California costs are reasonable. 

February 24, 2015

Rid of Your Allergies for Peanuts!

Desensitization, or is it familiarization.  I used to be allergic to my cat.  I kept is, and not no allergy at all.  When is our culture going to move away from "protecting" children from routine exposure to the natural world? 

Anyway, good news on peanuts, and now on to other allergens. 

February 23, 2015

More Details on How Bacteria Remember and Attack Phages

In hindsight, we all knew that prokaryotes had to have some mechanism to archive a memory of a phage attack.  So we have "adaptive immunity" in bacteria.  This has been known at least since 2007.  However, the present article outlines some of the mechanisms of the CRISPR complexes.  

Viral DNA Nucleic acid sequences of phage genomes are actually stored in individual bacteria so they can pass on the memory of previously contacted phages.  This allows the bacteria, and their progeny, to block replication of the same phage through a form of RNA interference.    

It is most interesting here that the phage sequence is stored in the bacteria without a "PAM" side sequence that is recognized by Cas9, thus targeting only the PAM containing phage version for miRNA cutting.  Otherwise, the system would cut its own archived phage sequences.

I wonder how much space is dedicated to these archives in bacteria and how they turn over with time. 

February 22, 2015

Side Effects of Anti-Addiction Drugs

All is in balance.  You can not get something for nothing.  The addictive drugs may provide pleasure that is paid for in pain.  The anti-addiction drugs, the same.  Some are fairly effective, though, when the user is motivated. 

February 21, 2015

TATA IP Strategies Still Seem to Reflect the Old Monopolistic Days

First time I was in India (1980s), about the only truck maker was TATA.  I was told they were licensing ancient German designs.  No competition at the time do to huge import taxes.  They essentially had a monopoly on several other industries also. 

Now, I see this article.  TATA Group conglomerate, boasts around just 60 patents. 

Also ..."so there is a lot of emphasis on trade secrets, but formally there is no policy on trade secrets."  Boy, that is a good one.  If you have no policy, you in fact do not have enforceable trade secrets at their U.S. facilities (could the law be so different in India?). 

No problem, TATA gets around this by "managing knowledge" with a company policy dictating that every year engineers must submit three or four papers among their colleagues, who then rate the work they have produced.  Thereby knowledge is captured and organized in a way that it can be re-used, and that the re-use of IP helps productivity.  Too bad this does not generate any intellectual property if they do not patent and don't know how to protect trade secrets.   Hmm ...

-----------------

I see, on further research, that TATA actually now has about 90 patents in the U.S. and about 250 applications pending.  

I wish them well. It is hard to dig yourself out of an earlier lack of competition. Too bad the Nano microcar project did not go better.

February 20, 2015

Beware of Overbroad "Reasonable" Claim Term Construction. 

Construction of claims is often broader in the PTAB than by Examiners in prosecution or the Federal Courts.  Here, the PTAB finds any sequencing of fetal DNA generally also (inherently) sequencing the "predetermined sequences" of the claim.  See patent at:  https://www.google.com/patents/US8296076?dq=8,296,076&hl=en&sa=X&ei=4ATmVIqrF4S0yQTvvoEQ&ved=0CB4Q6AEwAA  The PTAB deems sequencing of predefined sequences does not require predefined specific sequences to be targeted in the sequencing.  Thus, opening up the scope relevant prior art for the 102 rejection. 

In another case I am familiar with, claims requiring "sequencing" have been rejected based on art wherein a possibly complementary nucleic acid may HYBRIDIZE to the sequence of interest, e.g., even though this does not require 100% identity. 

In these cases, the reviewers fail to construe the terms according to what one of skill in the art would believe in light of reading the specification.  I know some patent practitioners cringe at the suggestion of providing express definitions in a Definitions section of the specification.  However, I believe key claim terms should be unambiguously defined so Examiners and the PTAB cannot suggest far out interpretations are "reasonable".  As a back up, you can always include other descriptions of key elements having alternate scope as support for amendments. 

I believe Stanford is appealing this PTAB decision.

At least this case is not rejected for alleged ineligible subject matter.   

February 19, 2015

Experimental and Regulatory Use Exceptions for Patented Drugs and Devices in China and U.S.

In the U.S. the rules for non-infringing "experimental use" are more strict than China.  This is generally acknowledged as the countries tailoring policies to their more or less developed high tech and biotech manufacturing environments.  One assumes China will become more strict when they have more to lose from infringement exceptions.    

In the U.S., use of patented inventions must be for non-commercial "amusement, to satisfy idle curiosity, or for strictly philosophical inquiry."  A further exception in drugs (and medical devices) is provided in Hatch-Waxman framework, 271(e)(1) broadly encompassing any use reasonably related to the development and submission of information under a federal law that regulates the manufacture, use, or sale of drugs or veterinary biological products (and medical devices).  This includes preclinical testing and testing data not ultimately included in the drug application.  Drug manufacturers are strictly prohibited from using a patented invention to develop their own different product.   

Initially, China was the opposite, with it being OK to copy an invention to make improvements, but not in the field of clinical experimentation.  Lately, this has been expanded to generally allow experimentation in all fields to characterize and/or improve the invention, even for business purpose.  In clinical inventions, China still does not include a patent term extension to make up for time lost in regulatory review.   

So, generally, China is more open in exceptions to "experimental use" of patented inventions without infringement.   

http://www.mondaq.com/article.asp?articleid=374754&email_access=on

February 18, 2015

Did They Steal Monopoly or Only Fame?

It appears Elizabeth Magie Philips deserves a lot of credit for outlining and inspiring the current Monopoly game.  However, she was apparently not good at marketing. 

She apparently applied for a patent in 1903, but never generated much interest or sales.  Patents last 17 years.  Darrow had a popular different version of the game, sold to Parker Brothers, apparently not infringing because Ms. Philips only "complained" in 1936.  She may have had a copyright, but the Darrow game apparently looked quite different. 

I do not see Ms. Phillips as a victim, based on the facts.  She did not self-promote or market well.  Good she at least gets some recognition now, but it does not appear anyone stole any property from her.   

February 17, 2015

Fake Journals Targeting Poor Helpless Developing Country Researchers

"What angers Shrime more than anything is that fake journals seem to target doctors and researchers in developing countries for whom $500 is an enormous sum of money. 'When you dig into these publications, it’s clear that the vast majority of authors on their table of contents come from lower-income countries,' he says. 'They’re preying on people who aren’t able to get into the mainstream medical journals because they come from a university that nobody recognizes or they have some other scientific disadvantage.'"

This comment assumes developing world researchers are not smart, and that scientists with little money don't carefully consider how they spend it. 

If research is good it will get published.  The respected journals are not in the business of brown nosing expensive schools or disrespecting foreigners (though good English writing skills can be important).   

Robbers don't target victims with no money.   Sellers search for a market with demand.  Here, developing world researchers have generated a demand for publishing services.  The bulk of the demand for these services is from scientists that are intentionally padding their resumes.  See, for example, the enormous pressure in China to publish, any way you can - http://phys.org/news/2013-11-reveals-black-china-paper-authoring.html

February 16, 2015

Bionic Leaf Process May be All Wet 

I recently read another article (http://www.greencarcongress.com/2015/02/20150210-silver.html) that stated a 3% efficiency using the direct cobalt catalyst creating the hydrogen/oxygen from sunlight to feed the bacteria generating isopropyl alcohol (IPA).

The suggestion to use photoelectrics (at least 25% efficient with energy conversion to electricity) for electrolysis (high efficiency) to make hydrogen (and separate useful oxygen) would very likely produce an overall IPA conversion efficiency overall of at least 5% (in a controlled bioreactor).  Then, one would have to separate the IPA from the water and bacteria.  (Boy, this is getting complicated.)  Maybe they could feed the excess biomass to goats. 

Possibly, it would be better if we could just keep working on a better way to store hydrogen (for internal combustion or fuel cell). 

(Anyone think I use parenthesis tooo much?)

February 13, 2015

Biology Soon to Conquer Electronics in Information Technology (With a Little Help From Electronics)

It is awful tempting to use the amazingly compact information storage of biomolecules.   

The slow aspects of molecular data storage have always been read/write.  However, e.g., with variants of maturing massively parallel sequencing technologies (e.g., ion torrent or fluor torrent), we may soon be able to challenge the supremacy of electronics even in rates of data transfer.   For example, with the nanocell volumes and molecular solution kinetics read/write could be fairly fast.  In certain embodiments, parallel read/writes in multiple cells could speed the process and even provide error correction. 

February 12, 2015

Improvements are Patentable, but Obvious Prior Art Combinations Don't Have to Be Improvements

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor.  That does not mean that obviousness analysis requires that combinations of art in rejections must be improvements over the art. 

February 11, 2015

Aluminum Cell Battery - Fill 'er Up

Like they say, this is a primary cell and can not be recharged by simply reversing the voltage. To recharge a car, one would have to install a hundred pounds of ingot anodes.  Can't pump them in, but should be able to devise a simple way for a machine to do it.

Finally, to reach their price point, they would still want to recycle the aluminum oxide hydrate slurry back to metal.  

Overall, it might be simpler way to convert electricity to a battery fuel than production and storage of hydrogen.   

Thanks, Victor, for the interesting article.

February 9, 2015

Tractor Manufacturers Use Proprietary Software to Tie Hands of Farmers

How frustrating.  I remember my uncle Jimmy in the Montana Bitteroot Valley when I was a kid used to do all his own work on the bulldozer and tractor.  Not sure about the "combine".  I can just see him now, black grease up to his elbows from doing routine maintenance at the end of the day.  He was mostly a potato farmer.

I just put a computer programmable ignition system in my 42 year old 240Z.  What a mistake that was.  Made the car a little faster, but less reliable.  I also do my own work on my modern pick up and wife's BMW.  It is great that government stepped in years ago and required a common standard for the OBD (on board diagnostics) systems by all auto makers selling in the U.S.  Lately, I have been using a $30 OBD blue tooth device and my smart phone to talk to the computers in the cars.   Without that, I would have to pay Ford and BMW.  

Real shame the big tractor manufacturers are playing an IP game with the farmers.  I can't see the government stepping in.  Maybe the farmers could have a boycott, or bargain for better access to their black boxes.  It is clear the manufacturers are reducing the value of their product to the farmers with these practices.  Maybe the first manufacturer with open code will receive a windfall in sales.   

I do not work in software IP much.  Seems strange that it would be a patent infringement to look at the software or modify it.  Probably a click-through software licensing agreement is the basis for this abuse of the farmers.  I am sure the restrictions are not even mentioned by the tractor salespersons.  

February 8, 2015

Digital Rights Management (DRM) Can Make Enemies of Your Customers. 

I quit buying HP printers the first time a refill of their own cartridge was not recognized.  Worst yet, I had an original first use HP cartridge I took out to clean and the HP printer would not use it because it assumed their own good cartridge was a refill, even though it was still half full of original ink.  So mad, I vowed to never do business with HP again.  I never go back on these vows (there is a long list).  (I wanted to vow not to deal with ComCast again, but didn't because they are no worse than the whole list of dishonest and manipulating ISPs and cable providers.)

It is a bad idea to make it clear you do not trust your own customers, even if some may be infringing IP (intentionally or not). 

Anyway, my staff insisted just last week that we get a Keurig coffee maker.  I argued against because the machines are so complicated, they always break down.  They finally talked me into buying a cheaper model; still uses the old cups.  No cup reader, and I intend to use what ever cups are the best deal.  If the machine breaks down too soon - "I will never buy another Keurig product again." 

February 7, 2015

Should an Invention be Patent Eligible if We are Allowed to Experiment ON (not WITH) the Invention?

So, with all that, we know that we do not know where we stand on experimental use of a patented idea.  

The article repeatedly tries to raise hope that experimentation ON the invention should not be considered an infringement.  Meanwhile, experimentation WITH the invention is infringement. 

The play of words seems to be in some fanciful hope that if it is clearly held experimentation ON an invention is not infringement, then a key policy basis for the recent tightening of subject matter patent eligibility would dissolve (just like government was supposed wither away to under communism).  Not likely.  That is, if experimentation on an invention is not infringement, researchers can continue making improvements, and maybe it is OK to allow patents. 

If such ideas could remove some of the gut feeling "unfairness" the SCOTUS seems to feel about monopolistic patenting of mankind's heritage, maybe the next wave of patent eligibility decisions 20 years from now will swing the pendulum toward greater eligibility, a little. 

February 5, 2015

Upgrade Your Children's Mitochondria

 Mitochondria are critical to our vigor and ageing processes.  See, also:

http://www.medicaldaily.com/mitochondrial-disease-more-present-older-moms-could-improve-genetic-counseling-306909

“In reality, it is a macabre form of eugenic cloning, in which a human being with a medical condition is killed and his or her parts are used to create a new human being with an improved biological state,"   

Not true.  There is no 46 chromosome "human" that is ever disassembled or killed.  The donor egg loses it's nucleus, the mother's cytoplasm (and bat mitochondria) are discarded.  Then a reassembled egg is fertilized into a potential baby.  In the course of a woman's life time almost all of her 100k+ eggs are lost, but all but the most politically driven would label eggs human.

The whole thing is a little strange, and not too useful, yet.    

February 4, 2015

"Patent Pending" Provisional Rights Against Infringers Rarely Enforceable
 
I often inform clients that they have certain rights against infringers while they have a published patent pending.  Today, I decided to look into this further.  The story is not pretty for patent applicants. 
 
After an inventor (Applicant) has a pending patent published, they can give notice to an infringer and eventually get damages (reasonable royalties) if the infringer continues to infringe and the patent issues with ‘substantially identical’ claims to those published.  See, 35§154(d) - http://www.law.cornell.edu/uscode/text/35/154
 
Case law essentially holds that the issued claims are substantially identical if they have the same scope.  In particular, claims can be amended and remain substantially identical if the scope has not narrowed.  I can argue both sides, but this seems odd to me.  Sadly, the case law does not reflect the fact that "substantially" means "being largely [mostly] but not wholly that which is specified" - Webster's. 
 
The case law seems to hold that any small narrowing of the claims means they are not substantially similar.  But, suppose the issued claims end up broader.  Then, the infringer has not had adequate notice, and was caught in an expanding trap.  Not fair.  On the other hand, if the claims are narrowed, the party given notice may not be considered an infringer because the narrowed claims shrink away from what the party given notice is doing.  The potential infringer given notice has avoided the net.  I guess the policy reason for not providing pre-issuance damages for narrowed claims is so Applicants do not use initial broad claims to scare possible competitors, and so that Applicants present claims likely to be non-obvious and enabled. 
 
One holding I find particularly unreasonable is  Honeywell Int’l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1140 (Fed. Cir. 2004) (en banc), where issued dependent claims are given no respect before issuance.  See - http://caselaw.findlaw.com/us-federal-circuit/1371896.html   Where a parent claim incorporates a dependent claim in an amendment during prosecution, it still has the same scope as the originally published dependent claim.  Yet this is somehow considered to be a narrowing amendment of the invention provided in the notice.  I haven't read the case, but doesn't make sense because the infringer was in fact given notice of a published claim that issued. 
 
The law subjecting pre-issuance infringers to damages was written to keep people from stealing inventions during "patent pending" prosecution and to motivate Applicants to publish.  Near as I can tell, the law is a joke since it is construed so narrowly that in practice it is rarely enforceable.

February 3, 2015

President Would "Save Money" by Reducing Drug Patent Terms.   

Certain people are quite willing to trade greater long term benefits for short term rewards.  That's why some people drop out of high school, and why some would rather have goose now than golden eggs later. 

Yes, the government can save money by taking money out of the pay back period needed to make up for research and licensing costs of the pharma industry.  No one will notice later that certain patients will not receive a cure for their disease because government has taken money that could have found a cure.  At least certain  people can feel good showing the short term benefit, and can paint the drug company fat cats as bad guys. 

The government would save "$3.5 billion in federal health spending over 10 years."  To follow through with the logic of the policy, Maybe the government should do away entirely with exclusivity periods for all name brand drugs.  Then, they could save $7 billion in the short run (and no one would even notice the good politicians policy led to the deaths of thousands around the world that never get treated in the long run with drugs never developed). 

February 2, 2015

Japanese Policy on Invention Ownership Not Working and May Change Again. 

If someone invents something, they own it.  If they invent something using some one else's facility, with an employment contract stipulating all work related inventions will be assigned to the company, then the inventor is an inventor and the owner of the patent application is the employer.  What business would employ someone to do research, and pay for all the overhead, then agree that any inventions belong to the employee? 

Inventors should only be "furious" if they a company takes their invention without a previous agreement that inventions would be assigned to the company.  If there is no assignment contract, too bad for the company.    

The article erroneously states that the "U.S. is able to acquire many global elites because they insist on giving large awards to innovators and contributors."  This is generally not true.  Many global elites start their own businesses in the U.S. and are both owners and inventors of their creations.  Most scientists in America have Assignment clauses in their employment contracts that require all work related inventions will be owned by the employer.  In exchange, the Scientists get guaranteed high salaries whether or not they stumble upon a breakthrough.  Many highly successful biotech companies pay very high salaries with great fringe benefits, but stipulate that if the Scientist does not publish and patent, they will be "let go", e.g., after 5 years, or so. 

A contract is a contract.  Both sides benefit, or they would not sign it.  A patent law requiring negotiations up front between Researchers and their Employers is a good idea, so any unsophisticated party is not taken by surprise, in the rare event a great invention is created at work. 

 

 

January Entries:

January 31, 2015

Non-Scientists Disagree with Scientists on Science.   

It might be argued that scientists are too close to science to have unbiased opinions on the subject.  Balderdash! 

Should uneducated people make decisions about science and technology, based on the teachings of Associates of the Arts?  That would be democracy.  The fifth branch of government is the media.  Problem is, media seems biased toward reporting sensational black and white stories where there is an antagonist and victim.  However, this is wrong.  Everything is life is a trade off.  A balance of factors pursuing the optimum benefit - like life itself.  In the long run, have there been more lives saved by pesticides feeding people, than poisoning them?  Haven't the scientists monitored and removed the worst culprits, like DDT?

All GMOs are bad.  Or so they say.  What if a GMO provided an inexpensive oil (as food and fuel) in brackish soil?  Would that be worth the risk that a foreign gene would disturb the overall balance of genes in the plant, leading to production of a toxin that would slowly kill half the population before we noticed what was happening (I am not making this up)? 

We should have more scientists in the media.  They are actually popular entertainers with their whiz-bang stuff on radio and TV.  Problem is, scientists like science (and journalism is a crowded field, paying little).  So ... should scientists just keep saving lives and pay no heed to ignorantly biased influence of the media?  Hopefully, success in science (green energy, cancer treatments, speedier communications) will continue to engender some confidence in science from the general public (without the help of talking heads). 

------ [More]

More mandatory  STEM (science, technology, engineering and mathematics) education in schools would help a lot, so high school graduates working in any profession could have educated skepticism of any claims. 

There has been a lot of talk about STEM lately (and during the space race 40 years ago).  Seems the problem is the competition with Federal Standardized Testing requirements for classroom TIME (the problem is not necessarily money; everyone was poor in Montana when I grew up and we were always at the top of the math scores).     

  

January 30, 2015

Inventor Heroes Get Out of Jail Free in China

Perversity again in China.  Things can look good on paper (remember the Constitution of the USSR?) but lead to perverse results.  Especially still, sorry to say, in China. 

Write a law that rewards contributions to society by reducing a prison sentence.  What do you get?  Probably a net increase in corruption and irony. 

First, the prisoner has a patent.  Who owns it? - the prisoner.  He made his own property.  He has the right to exclude.  He did not donate the invention to the public domain.  Maybe they should have a credit system so that people who already have a patent can commit crimes and not even have to go to jail at all, while getting rich on their wonderful patents.  Great idea.  Wish I had thought of it. 

Is the patent really worth anything?  Patents have been issued like running water in China for some time, but many have little value; and are rarely enforced.  I am not sure if the Chinese program includes the essentially unexamined Utility Model Patents. 

The worst aspect (reminding me of bribery and test taking scandals to get IN to good schools) is the buying and selling of patents in order to qualify for getting OUT of jail with a reduced sentence.  Let's see, commit fraud on the Chinese Patent Office, pay a crook for spoiled merchandise, commit fraud on the prison system, enjoy undeserved intellectual property, and get out of jail early for good behavior. 

You know, it would be easy to catch these guys, if anyone (not bribed) made the slightest effort.  If caught, they should spend extra years.   

January 29, 2015

Counterfeit Cancer Drug Smuggler Sentenced

How low can you go?  Fake Viagra is one thing, but what kind of person would take a few bucks to put a cancer patient's life at risk?

Good news is the U.S. supply chain includes relatively good chain of possession records to back track the bad guys.  The real problem is the drug supply in developing nations where you can never be sure of what you are getting.

January 28, 2015

The Taste of Good Health

Another causation/correlation case.  At least this one is not political.

Does the ability to taste umami cause good health?

January 27, 2015

The Solution to Batteries is Not a Solution, but a Dryness

Dry. Now I know why we lyophilized so many different drugs when I was a process engineer.  Now, if I could only make my humor more dry.

What if we could gust get these batteries into a Tesla?  Think how far we could go, and how long it would take to get there. 

January 26, 2015

A Machine Proves Women are More Emotional!

Women are more emotional and more emotionally expressive.  Who knew? 

It seems strange this is the first time a researcher has used fMRI (functional magnetic resonance imaging) to demonstrate this difference. 

Personally, I am a guy and, like other men, I am very much in control of my emotional expression and temper.  

--------------------

Army Gets the Lead Out, But Pays the Green to Be Green in Bullet Infringement Loss

More than just a lead slug.  The infringed bullet has hard front and back ends connected with a weaker connecting material.  The connecting material can be softer (like a copper alloy, but preferably not lead) to interact with the rifling in the weapon barrel.  See:

https://www.google.com/patents/US7748325?dq=7,748,325&hl=en&sa=X&ei=LMvBVPjaJoOnNr_dg4AO&ved=0CB8Q6AEwAA 

On impact, the front and back sections split from each other.  Not a Dum Dum, but fragmenting.  There may be a void between the front and back to include various lethality enhancing substances. 

The good news is the bullets replace soft lead with less toxic soft metal alloys.  "Green" bullet because while lead has a specific gravity of 11.3 g/cm3, certain claims require less dense material.  Funny, many claims state outcomes without defining the structures or materials.

It is amazing that very time I shot at a rabbit as a child (hunting at 11 in Montana), I left a couple grams of led in the environment.  I could make any number of jokes, but I will leave it at that. 

January 25, 2015

Did the Apple Camera Patent "Cause" the GoPro Stock Drop? 

Here is another article with insightful comments about the GoPro stock drop. 

http://www.mondaq.com/article.asp?articleid=366966&email_access=on

The issued claims are very narrow and would be hard to actually infringe.  It is not like Apple was granted a patent to small portable video camera, or something:

http://www.techattache.com/files/2015/01/pat8934045.pdf

The stock drop may actually have been "caused" by the patent grant.  (Although I thought the market was more sophisticated and could have followed the prosecution all along on PAIR.)  The cause was psychological.  The patent showed seriousness.  The Figures show advanced designs. 

How many times the size of GoPro is Apple?  No one likes the thought of being squished. 

Anyway, got to love these cameras.  Now, I have a movie of me falling out of an airplane at 170 mph.  How cool is that?

January 24, 2015

Super Complex Cars - The New Planned Obsolescence

What I find disturbing about new cars is a new system of planned obsolescence has been introduced, apparently unnoticed. 

In the old days, cars were designed to fall apart (e.g., 120K miles max on an engine) in 10 years, so you had to buy a new one.  That was before Japanese quality showed up and ruined everything for the non-competitive U.S. auto market. 

Now, cars are extremely reliable.  However, even with very high levels of quality and reliability, cars are again going to be basket cases when they reach 10 years of use.  While my 1972 Datsun 240Z has maybe 10 systems (heat, wipers, radio, lights, gages, manual seat, mechanical window, interior lighting ...), new cars will have 100 systems.  Even with a 1% failure rate per year, something will be breaking down every year (at first), only to increase with time. 

I have a fairly modern truck I drive, when necessary.  It thinks a door is ajar, when it is not.  The dome light comes on when I get in and will not go off when I an trying to back up in the dark, then again does not go off for 10 minutes after I park it.  Maybe I need a new $800 computer (which will not actually fix the problems).  

I can only imagine how many unfixable parts there will be in current cars 40 years from now.  Will there then be any fully functional 2015 "classics" in 2055? 

All the systems work on my 240Z, except the computer I installed to replace my mechanical distributor points set (what is wrong with me?)

January 23, 2015

Milk Cows with Human Antibodies Against Ebola

Not as much of a fluff piece as I expected from NBC News. 

Holstein-Jersey cows with "fully humanized immune systems" are subjected to DNA vaccine against Ebola.  I couldn't tell how many antigens were encoded.  These cows are milk cows.  I wonder if they would get any IgA?   

Even is the serum is not a cure, I imagine it would at least help patients a little, especially if given early. 

January 22, 2015

Loopy Complexes at the Heart of Chromatin Organization and Expression Control. 

Well, I am caught unaware, again.  I had never heard of these chromatin loops.  What blows my mind is the huge number (billions) of nucleic acid (NA) sequence alignments and contacts that occur at any given time in a single cell.  The amount of information in the contacts alone is incredible, much less the much more complex information being passed by NAs and proteins associated with each contact.  The information passing in a single cell due to the loop phenomena alone seems to rival the information passing in a neural network (brain). 

Although not mentioned in the article, of course, there are certain peptides facilitating the contact interactions of the NAs.  For example, there is a CCCTC-Binding factor (CTCF, a Zn finger protein) in a complex with cohesin complex.   Did I say COMPLEX.  See a 2012 article on the subject:

 http://www.pnas.org/content/109/51/21081.short

January 21, 2015

Another Link Between Chronic Inflammation and Cancer

I guess the connection between inflammation and cancer has been has been on the radar screen for many years.  I even remember a report years ago suggesting a connection between throat cancer and drinking carbonated water; you know that burning in your throat when you drink it too fast.  Then, there are liver cancer with chronic HepC, cancer reductions with regular aspirin use, etc.

I also read another article recently where cancers were associated with excessive turn over (divisions) of cells, often caused by inflammation:

http://www.bioquicknews.com/node/2088 

The interesting aspect of the current MIT article is the fact that the incidence of cancer is not increased much by acute inflammation because the DNA repair systems have a chance to clear damage.  But, chronic inflammation leads to higher levels of oxidation and DNA damage.  The damage is increased, and repairs less effective, in conditions where cells are dividing a lot.   

So, moderation in all things.  Avoid alkylating agents, take aspirin, and don't guzzle your Perrier. 

January 20, 2015

 Software Eligibility Overview in Light of Accumulated Court Cases

This is a good overview of the new guidelines and court cases around patent eligibility of software. 

It may be a good strategy to present claims in a way that influences the subjective biases of readers to characterize the claims as directed to other than an algorithm.  Thus avoiding rejection based on part one of the two-part analysis. 

Ironically, one of the best ways to influence the part one analysis is by presenting claim elements in a way that passes part two analysis.   Draft the claims so that they are narrow (not monopolizing humanity's heritage of the all powerful algorithm), adding physical elements that make the claim "more than" the algorithm.  As a practical matter, it seems you may have to ultimately focus the claims on the specific embodiment you intend to practice in the market place to have a good chance of allowance and IPR validity.

January 19, 2015

Pole Dancer Takes on Martial Artist with Venum
 
This case makes some sense because a trademark registrant can not be totally sure of the timing and areas of use down the line. 
 
Regarding the starting when to start the three year clock on nonuse of a mark constituting prima facie evidence of mark abandonment, it is nice to have precedent for an objective standard. 

January 18, 2015

Bio/Pharma R&D Down in U.S Without Recession for Excuse.   

Charts make more sense if you know they are normalized to 2012.  So, Pharma/med R&D are up across the board, but not keeping up with inflation.  Biotech is growing more than I expected. 

With all the talk about how difficult grants are to obtain in recent years, I had expected NIH spending to be way down.  Maybe it seems that way because there are more people filing for grants, or fewer people getting bigger grants?

China R&D investment growth was 17% over 7 years, to almost $10 billion; against the U.S. $117 billion.  Much is made of the U.S. fall from 57% of the world total to 44%.  Well it is easy for other giant countries to grow from 2% to 4%, but you can not grow from 57% to 114%.  It will be great when other countries pay back the U.S. back by saving some of our lives with their new drugs. 

Still the main message is not lost.  Biotech spending should be increasing in the U.S.  Some problems are that the media vilifies biotech (charging sick people money pills they need to live), foreign countries paying for manufacture but not R&D losses, the patent office now considers many hard found discoveries not to be patent eligible, and taxes and regulations make it easier to do research almost anywhere else.   

See the actual JAMA article at:

http://jama.jamanetwork.com/article.aspx?articleid=2089358

January 17, 2015

Why Can't Most Big Corporations Innovate on a Big Scale?

On introduction, sales go only to the "innovator" purchasers; accounting to only 2.5% of the total product cycle sales.  The article bemoans the fact that there is a time lag between innovators and the much larger group of "early adopters".  The article does not mention that, for MOST products, the sequence stops at the innovators.  At least some of the development losses are mitigated by the prices innovators are willing to pay for new stuff.   

The only consistent way for big companies to grow in the long term is to not lose money on the average new product.  They need to do lots of well managed small projects.  Eventually, they will get a big ("blockbuster"?) product to go with the other one that made them big in the first place.  The problem with a lot of mid to large-sized pharma companies is they get a big head and rest on their laurels (am I mixing metaphors?) thinking they can ride the first product forever, or that they are special and will soon come up with another big product.  It Ain't Gunna Happen. 

I suppose really big companies could run dozens of small well conceived projects intended to complement the over all business plan, with each project headed by a Director or VP with skin in the game.  Then, on the average, there could be incremental small successes that provide good growth.  Who does this?  Instead, most large pharma corporations just look around and buy the successes of others (whether they are a good fit or not). 

Lucky can make a small company a success, but not a large company.  Big companies can afford to buy success, but not by going on a buying spree.  They have to wait for opportunities to buy perfect fit small companies with market values far below the value added to the big company.  Too bad most large companies do not seem to be good at waiting or fitting.    

January 16, 2015

USPTO Program to Delay Missing Parts Expenses is Extended

It is pretty rare I have a client needing another twelve months to decide if they want to go through with conversion of their Provisional application to a Utility application.  Where this would be more valuable is if they could put off the much higher Patent Cooperation Treaty (PCT) fees a while longer.

January 15, 2015

Complicated Cancer Treatment.  But, Heck, If bDNA Can Work, Anything Can

Boy, this seems too complicated. OK, toxins with ligands directed to cancer cell targets. Stem cells (not sure the advantage over non-stem cells - but they are the cells on all our lips!) in protective capsules secreting the toxins, which diffuse through the capsules. Implantation near the cancer cells. All in a day's work.

What could go wrong? Immortal cells. Pluripotential - what will they differentiate into? I suppose the capsules are biodegradable. Hmmm. Maybe I should read the journal article.

Sorry, I am usually a cheer leader, but not today. I just put a computer in my 42 year old car to run the previously mechanical ignition system, and it is giving me no end of trouble. Too complicated.

January 14, 2015

Big Spike in Drug Approvals.  Is it a trend?  

This is great news and long in coming.  The drug business has been getting over ripe.  Didn't I read the other day that only about 10% of drug sales are not generic?

Not to be sour grapes, but these approvals have long lead times and reflect conditions some 5 years ago.  Hopefully the bad press to pharma, difficult new challenges in patenting biologics, likelihood of increased government (foreign and domestic)  interference in the market, and the greater competition for key markets will not blunt this trend of increased approvals. 

January 13, 2015

Diversity in Cloned Stem Cells Influences Implantation Results

I had been wondering about so called somatic stem cells.  There has been some media suggesting that they were all so wonderfully pluripotent.  However, from my embryology courses, I had a gut feeling that it would not be so easy, e.g., to force a stem cell from a mesoderm-derived tissue to differentiate into cells of a tissue normally derived from ectoderm.   

This review by Hart (J. Biomedical Science and Engineering, 2014, 7, 526-532) gives a great overview of issues, but asks more questions it answers.  Mesenchymal stem/progenitor cells (MSC/MPC) were found to vary in multi-lineage differentiation potential.  Standard characterization of stem cell clones by surface antigens failed to identify the diversity of the clones derived from adult tissues. 

Consistent stem cell harvests were difficult to obtain (making clinical use unpredictable).  Variants may be due to age, sex, genetics, environmental factors (inflammation, nutrition, stress), replicative senescense, and epigenetics.  Stem cells may be influenced by mircoenvironments within the same tissues where they are harvested or implanted.  In any case, different batches of stem cells seem biased toward different differentiation results, based on unidentified factors. 

I was very skeptical of a recent article concerning preparation and implantation of "fat stem cells" to treat any number of pathologies, e.g., including Parkinson's, MS, MD , and Alzheimer's.   See:  http://health-innovations.org/2015/01/02/scientists-identify-new-immune-response-via-human-fat-cells/   Other research has shown that only a very small percentage of implanted stem cells eventually reside at the intended cite and differentiate as members of a damaged tissue.   The fate of the rest of the cells remains unclear. 

In another rather crude experiment, a spinal cord damaged patient received nasal tissue thought to contain neural stem cells.  Although some neurons with fibers did grow in the injury site, they did not integrate functionally.  Meanwhile, mucus cells also seemed to reside and produce their excretions.  See: http://www.newscientist.com/article/dn25859-stem-cell-treatment-causes-nasal-growth-in-womans-back.html#.VLFjvivF98E

Implantation of diverse stem cells could actually provide a better result by providing multiple cells types necessary in normal tissue.  However, what do you think the risks could be to implanting stem cells that are not fully characterized? 

January 12, 2015

Higher Maintenance Fees Tend to Prompt Lapse of Lower Quality Patents.  Imagine That.   

No surprises here.  With higher maintenance fees, patents rated lower in parameters thought associated with quality patents tend to be dropped, while higher quality patents are retained.   

Patents held by owners with large patent portfolios tend to be higher quality.  Large portfolios also tend to drop fewer than lower rated patents.  I suppose single patent holders have less money and less experience marketing their inventions, so are more likely to allow lapse of their patents, regardless of quality. 

January 11, 2015

New Family of Super Antibiotics? Teixobactin Against Peptidoglycan Formation

I saw in the general U.S. news media that there was a antibiotic family that does not prompt resistance which kills famous super bugs. So I went to BBC and got a bit more real information. 

Well, it is nice to have a new family of antibiotic.  You may be able to view the Nature article at:

http://www.nature.com/articles/nature14098.epdf?referrer_access_token=Vw2XuTrPtaUhN-4-uwl_3NRgN0jAjWel9jnR3ZoTv0PvwA6rMMnycnymQk5ZOpb5ktLjj6cTh7j_4Otw8h3aTCNKRJecp4ZZwKptnKS1oJfw_lflS93HhwOUNLnez6M_

The technique of cultivating bacterial in their own natural environment is not so new:

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5&f=G&l=50&co1=AND&d=PG01&s1=135960.APN.&OS=APN/135960&RS=APN/135960

Anyway, teixobactin was isolated from Eleftheria terrae and is apparently a strong inhibitor of peptidoglycan formation (best against gram positive bacteria) with good pharmacokinetics.  Teixobactin binds to several targets, none of which is a peptide, so resistance may not be easy to evolve.   Even if it is not as good ay hyped, it may well be a good starting point for modification and improvement. 

January 10, 2015

Far and Away Most Cancers Due to Random Mutation in Stem Cells, Not Environmental Factors

So, colon cancer is just a c**p game.  Sorry.  Couldn't resist.

The correlation coefficient is very high between published stem cell turn over rates in tissues and rate of cancers in those tissues.  I bet even many environmental causes of cancer are merely due to stem cell turn over due to irritation from the environment (smoking, asbestos, sun).   

That being the case, the author is right that efforts might be better spent on early cancer detection than fighting environmental or life style causes. 

Makes you wonder if lives saved avoiding pesticide residues on fruits and vegetables to avoid cancer are more than made up by death from obesity in those that eat fries instead. 

January 9, 2015

PTAB Claim Amendment Standards Require Disclosure of "Known" Universe 

The patent owner "is expected to reveal its relevant knowledge."  Known art.  That is a small universe.  At least they are not expected to do a search and prove a negative.  This standard for PTAB proceedings amendment seems the same as regular prosecution. 

The same for written support.  I always provide a description of where to find support for any amendments during prosecution.  Otherwise, the Examiner may object; sometimes without actually looking for himself.  

Not sure what is up with this requirement that the patent owner must identify written description support for the entirety of a substitute claim in the original disclosure, not the issued patent specification.  Does this refer to the rare amendments to the specification, e.g., identifying material incorporated by reference, or describing in text what is in the figures? 

Over all, the TPAB standards seem pretty usual, and maybe generous, considering they are allowing amendments in a post prosecution proceeding.   

January 8, 2015

What Information Does a "GMO" Label Provide?

On the news yesterday I heard a politician suggest that everyone has a right to know if a product is GMO, and there ought to be labels.  In the next breath he admitted that almost no one knows what a GMO is.  In any case, he said, until GMOs are proven safe, there ought to be a label.

I am all for information availability, but the information should be useful.  If everyone is afraid of GMOs (e.g., frankenfood) without a reason, what good is a simple "GMO" label?  Maybe it would be better to label GMO products like any other products.  That is, where there is a known hazard, e.g., allergen (peanuts), toxin (cigarettes), health issue (hydrogenated oils), it should be on the label, case by case. 

I see little chance the general public will ever understand GMOs generally.  Where there is a significant issue with a GMO product specifically, the media and pundits can raise the issues (e.g., on Good Morning America) and get the specific useful information out so consumers can make an informed choice. 

January 7, 2015

Difficult Times Still Ahead for Patent Enforcement and Litigation in 2015?

I like this well written prediction of trends in patents and patent litigation for 2015.

Thank god my law firm is not heavy into patent litigation.  Litigation is already way down due to the inter partes review (IPR) options, and reduced expectations of enforceability for patents written in a different era.  It will only get worse if the fee shifting legislation takes hold in 2015. 

I have to say, I think that fee shifting and simpler dispute resolution (i.e., IPR) are generally a good thing.  The negative aspect of these changes is the attitude of politicians and media that may go too far and harm, e.g., non practicing entities (NPRs), or even harm practicing patentees trying to diligently protect their valid intellectual property. 

From the point of view of patent prosecution, the news could be good for firms that draft quality applications and strongly argue legitimate points during patent prosecution.  The best defense against the post-grant hazards should be a broadly supportive specification, a patent prosecution history, and indisputable claims. 

January 6, 2015

CAMP Kills Microbes in Skin

Well, for starters, they might have given the antimicrobial peptide a different acromyn than CAMP.  Naming a molecule in biology is getting like trying to find a name for a trademark or ID in Google mail.  Now, how is cyclic adenosine monophosphate killing bacteria?

Anyway, it appears that fat (stem?) cells secrete cathelicidin antimicrobial peptide or CAMP in the presence of bacteria.  CAMP is apparently a part of the innate immune system that can destroy the lipoprotein membranes of microbes.  Historically, this was shown to take place in phagosomes containing bacteria after fusion with lysosomes in macrophages.  Here, the fat cell CAMP is apparently secreted on contact with bacteria.  I assume there is also a pathway wherein the presence of this CAMP calls immune cells to the site. 

Obese subjects have been observed to have more CAMP in their blood than subjects of normal weight.  Although obese patients are more sensitive to Staph infections. 

It has been suggested that the diverse family of CAMP peptides should be reviewed as a source of potential "antibiotics".  Call me an old grump, but I have a gut feeling that CAMPs are not generally highly potent, and may produce side effects when taken out of their normal balance.   

January 5, 2015

Cellulose/Lignin Construction not a Path, but a Thicket 

How can we get that nasty ole lignin out of the way so wood can be used to make biofuel?

Well, I guess this is a breakthrough in understanding of how cellulose and lignin production is moderated in plant cells.  The less good news is that the network of protein/DNA interactions is extremely complicated and unlikely to be disentangled any time soon. 

See figures from the article at:

http://www.nature.com/nature/journal/vaop/ncurrent/full/nature14099.html

January 4, 2015

Peptide Synthesis by Quality Control Protein in Cells

The protein in need of repair is not shown in the figure presented, so guessing the interactions is difficult.  And, is the mRNA already released?

I believe we have a subscription to Science in my office.  I will look into this further. 

I had thought such faulty proteins usually went about their inefficient business, or were destroyed by quality control proteases.  This is the first I have heard of a system attempting adjustments to a protein in the process of translation. 

The author raises issues around disease states in neurology (CJD does come to mind as relevant).  Seems errors in other master signaling proteins, and such could also be to blame for other disease states. 

Anyway, the diversity of information control in cells never ceases to amaze me.

January 2, 2015

Generics Lined Up to sell Viagra Everywhere But U.S.

Apparently, Viagra (sildenafil) was patented by Pfizer in 2002, and the composition patent expired in 2012.  Initially, the indications were hypertension. 

Pfizer retains a patent US6469012 (https://www.google.com/patents/US6469012?dq=6469012&hl=en&sa=X&ei=zW2kVPr0EeOr7AbSv4HoCg&ved=0CB8Q6AEwAA) for methods of ED treatment.  So, even if you get Viagra prescribed to treat your hypertension, you are infringing if it also cures your erectile dysfunction (though you do not want to know how Pfeizer is going to find out). 

Does anyone know about the court case that apparently extended the methods of treatment patent term?

See more information at:   

http://www.accessrx.com/research/viagra-patent-expires/  method of treatment ED

January 1, 2015

Disney Sued for Frozen Plot 

What goes 'round comes around.  Disney seems to stretch their copyright infringement accusations too. 

I suppose the Snowman makers are now enjoying some additional press and may get a small settlement (or a huge legal bill).

-----

Generic Drug Prices Jacked Up?

What the article apparently fails to mention is why the price of the listed generic drugs can sky rocket.  

I have seen reports for some generic drugs where the price got so low, all manufacturers but one got out of the market. Then, the remaining manufacturer jacked up the price. I assume that the high priced generics are almost exclusively for drugs with only one manufacturer. And I assume (and hope) that new manufacturers will enter these markets and force prices down some.

However, we know the cost leaving is low and the cost of entry is high in drug manufacturing.

December Entries:

December 31, 2014

Rampamycin Does It All - Longer Life Anyone?

Wow, Rapamycin does it all.  Is this the next aspirin? 

Rapamycin was initially discovered as a antifungal compound produced by a Streptomyces species on Easter Island.  How cool is that?  Then, they discovered that it has immunosuppressive effects in humans.  Have to be careful, because the immunosuppression is associated with increased chances of certain cancers. 

But wait, in mice it apparently reduces certain common cancers and extends their life span, though it apparently does not inhibit most signs of ageing.  Rapamycin influences SLE and muscular dystrophy.  Spread it on a stent to prevent restenosis. 

Also see 2013 article:

http://www.sciencedaily.com/releases/2013/07/130725141715.htm

 

December 30, 2014

Nucleic Acid Cross-Linking Reduces Pathogens and GVH in Platelets 

I recently read an article (http://www.drugs.com/news/fda-approves-first-pathogen-reduction-plasma-54304.html) wherein UV activated DNA cross-linking was used to inactivate pathogens in plasma.  No reason it should not work in the clean up of platelets, which have no nucleus. 

Still, I have questions.  "The platelets are then purified to remove the chemical and its byproducts."  If the chemical (psoralen derivative?) is cross-linking nucleic acids (e.g., in a virus, bacteria, white cell, or even the RNA in the platelet cytoplasm) how can it be removed? 

OK.  I looked into it further.  See, e.g., http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3132977/

The psoralen derivative amotosalen is adsorbed with a "compound adsorption device" (CAD).  No article appears to actually discuss the nature of the CAD.  For example, what is the nature of the ligand binding the amotosalen.  Seems unlikely that it would be able to bind cross-linked nucleic acids inside cells. 

In any case, the maker (Intercept) reports no cancers caused by their technology.  They report no toxicity, even at 1000X the clinically used levels of the amotosalen, e.g., even if the blood product is not depleted with the CAD system. 

I would still like to find out more about how this system works.   

December 29, 2014

Here Come Fat Stem Cells to Save the Day

I do not have all the facts, but the "infusion" of expanded "stem cells" from fat for a fee does not seem ethical or legal, in many cases. 

Expansion of stem cells from fat probably is a significant modification because of the expansion and likely change in the character of the cells.  Infusion back into the patient should probably be considered an implant of a medical device, subject to FDA rules.

Fat is mesoderm origin.  I am not sure what disease state could be cured by "IV drip" of fat stem cells.  Certainly not MS or Parkinson's.  Where would you inject for MS?  Wouldn't the cells have to be at least partly differentiated and injected into the brain to treat Parkinson's?

I hope someone is at least collecting data on these chaotic experiments.  As far as I am concerned, fully informed desperate people should have options.  But maybe they should not be charged until data show safety and efficacy for their particular indication. 

December 28, 2014

Would the Price of Chinese "Import Substitution" be Isolation?

"Import Substitution" has not worked for China in the past, or for anyone. 

I was in India in the old days, when they practiced import substitution and protection of internal business.  Everything was expensive junk. 

A strategy of expanded trade secrets and import substitution might work in China, in the short run.  When the government runs everything, who needs patents?  Trade secrets would work as well in many cases.  The Chinese government can control who uses what technologies and trade secrets internally, without worrying about reciprocity when it comes to foreign patent enforcement.   

I do not see things going that way, though.  The present system has been working well for the Chinese, now that they have inventions of their own needing protection around the world.   Further, lack of reciprocity and manipulation of markets may lead WTO trade disputes.    

The main reason I do not see China going too far down the path of import substitution is that the isolation may waste energy generating products not suitable for the export market.  Why do you think they bought IBM?  If they spend too much time reinventing the wheel and producing incompatible technologies, they may kill the golden export goose that has drug them out of the 19th century.

December 26, 2014

India Court Sides with Novatris in Onbrez Patent and TM cases. 

The fact that Cipla intentionally mimicked the Onbrez trademark shows they have an adversarial attitude and act in bad faith. 

Then, Cipla apparently filed for compulsory licensing without any attempt to obtain negotiated licensing. 

Don't these guys (Cipla) obey any rules?

Good the India Court has followed their own rules and played no politics in this case.  Still, if Novartis is not practicing the technology of the drug in India, they might be wise to negotiate a rate reflecting Indian demand and resources. 

December 21, 2014

"Comprising" is an Open Ended Universe.  Don't Suggest it is an Unduly Difficult Universe.

Promega claims required products to include all three loci.  The claims were rejected for alleged lack of enablement for products comprising the three loci Plus Additional Loci. 

According to the Court's logic, Promega could have claimed  products "consisting of" the three loci, but could not claim products having the three loci plus one unidentified loci.  Hopefully, the PTO will not take this a generic holding and deem that no "comprising" claims are enabled, only "consisting of" claims.  . 

An important fact here is that Promega represented to the Patent Office that the addition of even a single locus to an existing loci combination rendered that new loci combination

patentable.

How could they have claimed more than just the array reduced to practice?  Maybe avoid the word "comprising" with "including"?  Maybe not stating in the specification that additional loci are difficult to practice.  Maybe by ensuring that the specification teaches a generic method of identifying additional loci. 

December 20, 2014

Can PTO Give What They Do Not Own?  New 101 Guidelines

I had always argued that new combinations of two or more natural substances should be patent eligible (contrary to the now discontinued [discredited?] gun powder example). 

There is also the news that claims that do not tie up a natural substance should be subject to streamlined review.  And, where there are two or more natural phenomenon, it seems that facts show one is eligible, the Examiner does not have to go on to the next (we shall see).  Among the variety of new Guideline options, Biotech seems to now have a stronger position.

But, the PTO does not Legislate, and Judicial case law trumps, so get ready to argue facts applied to closest case law (if Examiners even know what that is).

December 19, 2014

More Data May Enable Broader Monoclonal Antibody Claims

Fascinating discussion of combined antibody and protein conformation definition to provide advantageous "edges and angles" in peptide engineering. 

This is very important from the point of view of patenting peptides and interactions.  Even though a protein engineer could modify a protein (even an antibody variable region) with the expectation of retaining (or even improving) binding affinity, most patent offices around the world have long limited most antibody claims to a very specific set of 6 CDR sequences. 

Because Dr. Lawson, and UCB (apparently not one of my clients - UC Berkeley) Pharma, can present so much specific data on protein/protein and antibody/epitope interactions, they can be justified in obtaining antibody patents of broader scope!  The Examiners brush off my enablement arguments based on Goa's work (e.g., Human Mutation, 30 (8),1161–1166, 2009). 

Finally, a way to "persuade" an Examiner away from the unique sequence dogma that has settled into the antibody patent prosecution. 

December 18, 2014

Technology to Reduce Pathogens in Plasma

Amotosalen is a psoralen compound that cross links nucleic acids in the presence of ultraviolet light.  Plasma for injection into patients is exposed to the chemical and ultraviolet light.  Then the Amosalen is removed.  Does anyone know the method of removal (and does the method also remove the crosslinked nucleic acids)?  

The clinical study showed no additional adverse effects of using Amotosalen to reduce viral loads in plasma.  However, the chemical only reduces and is not guaranteed to eliminate pathogens.  I did not see any data showing a reduction of transmitted blood born diseases. 

See Intercept corp  product description at:

http://www.interceptbloodsystem.com/product-overview/amotosalen-mechanism-of-action

December 17, 2014

New Patent Office Patentable Subject Matter Guidelines Really are New. 

Well, this is a surprisingly exhaustive reconstruction of the patentable subject matter Guidelines for the Patent Office.   

There is one simple block flow diagram controlling analysis for both process and products.  See it early in the document.   

Look up "streamlined" review (Part I.3.) wherein if the claim "clearly does not seek to tie up any judicial exception such that others cannot practice it. Such claims do not need to proceed through the full analysis ..."  That is, if the claims do not tie up a substantial range of used for the natural product, the Examiner does not have to go on to see if the claim is "directed to" the natural product and to see if "additional elements amount to significantly more" the judicial exception (e.g., natural product or mental process).  There is some logic in this (imagine this at the PTO).  If a natural phenomenon is not tied up by the claim, there must be significantly more to the claim.  This opens up better arguments for some of my cases, where the bulk of uses for the natural product are not within the scope of my applicant's claims. 

The Examples section of the Guidelines essentially sticks to descriptions of controlling case law.  Gone is the example where gunpowder was considered a natural product.  If the claim includes several natural products, only one natural product need be reviewed.  If the combination with other natural products adds significantly more [or narrow the claim so the first natural product is not "tied up"?] subject matter should be considered patent eligible. 

Again, the Guidelines reiterate that the Examiner must still do a full analysis of novelty, obviousness, enablement, etc.  I have had some first Office Actions lately with only a section 101 subject matter rejection.  I got the feeling the lame 101 rejection was just a way for the Examiner to avoid the work of actually examining the application, while still getting his/her points.   

Overall, it appears the Patent Office has become a little more rational, and maybe fair.  We will see how the new Guidelines are implemented. 

December 16, 2014

How Can We Avoid Wars of Attrition with Patent Ogres?  

The reason a bully on a school ground is willing to push littler kids around is he knows he will only be hurt 1/10 as much in a fight as the littler kid.  And, the fight will never happen. 

Regarding patent ogres, the case is the same.  With the current legal system, I see no solution to motivate big businesses not to behave as ogres.  Even if you make them pay the little guy's fees, should the ogre lose, the ogre still has relatively minor injuries.  And, more often than not, the guilty ogre is never shown to be guilty, because the case "settles" or the small guy runs out of money before a verdict.

There is one direct way to make the litigation as painful to the ogre as the small guy (and I do not support it as a first step).  Remember that law in Sweden that hands out speeding tickets in proportion to the wealth of the speeder?  The speeding ticket is assessed according to the wealth of the speeder.  A poor speeder with a wealth of $10k is fined, e.g., 1% of wealth- $100.  A rich speeder with a wealth of $10 million is fined $100k for the same offense.  

What are the problems with such a system?  Well, first of all, who would get the money, and what perverse incentives would it spawn? We could probably get the government to write such a law, if the fines went into general tax revenues.  If the little guy got the money, what productive actions would they take with the windfall?  Because big companies have a much higher level of exposure, wouldn't they be swarmed with many small guys, perhaps leading to their destruction? 

Another analogy.  In nature, a grizzly bear will not tussle with a badger, even though the bear has a 20x size advantage.  The bear could eat the badger, but has a significant chance of receiving a substantial wound.  When the bear and badger come across each other, there is a lot of posturing, while they size each other up.  If the facts show that the badger is in a good position, e.g., defended in his den entrance, the bear will decide it is not worth it to attack. 

How can we apply this to the world of big and small IP parties?  The parties should be provided a good way to present the real facts for a simple resolution, followed with the significant chance of harm to the party that ignores the facts. 

It seems the only way for fair resolution, that does not become an unbalanced battle of attrition, would be to have a two phased justice system.  The first part of the system would be simple and inexpensive. The two parties would be required to present up front FACT BASED arguments supporting their position.  This could work, e.g., where the infringement is to a device patent where discovery could be as simple as examining an allegedly infringing gadget.  If a party lost the simple case, and wanted to move on to an Appeal, then, maybe they could be subject to fines proportional to their worth.  Hmmm....

Any ideas?  

December 14, 2014

Who Does Not Need a Patent?

I agree that patents are more important for biotech and medical devices than for high tech inventions.   

Who does not need a patent?  About half the time I advise small unsophisticated clients that a patent would probably not be cost effective for them.  They are often starry eyed and need a reality check on the time and costs of patenting and marketing an idea.  Or ... their idea is not new. 

Regarding early stage companies, I differ with the statement that "early stage companies pay three times more" than larger corporations.  I could not find such data in the linked report (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1429049).  With my early stage cost consciousness of start up clients, we often find ways to reduce costs and focus on early priorities.  I often provide low cost or free advice, to help them get started and build a relationship.  I imagine other firms do this, but maybe not.

December 12, 2014

Court Orders Maker to Continue Sales of Alzheimer's Drug Near Patent Expiration

I believe the patent on the original Namenda Alzheimer's drug will expire next year.  Namenda XL is a one dose extended release form with more years left on the patent. 

maker is trying to force all patients to switch to the XL dosage before the original patent expires.  My understanding is they are trying to accomplish this by ending sales of the original patent expires and generics have not yet started sales.  By the time the patent expires Actavis (the maker) will have retained their full market share and patients would have an administrative burden of switching to generics.   

Seems pretty manipulative.  The New York Attorney General has sued based on anittrust allegations. 

December 10, 2014

China's Patent Filing Great Leap Forward.

I have seen fragments of this data before, but Reuters has put it all together.

I had seen that China filed more patents than anyone else, but thought many must be those low quality "utility Model" patents.  Nope, they file more Invention patents requiring strict review in prosecution.  Still, there must be something not quite right, considering the very low number of CN patents filed in other countries.  If they were valuable, wouldn't they file outside? 

The rate of filing CN to JP is very low, while the filing from JP to CN is high.   Any ideas why with is? Lots of foreigners (US and JP) file in CN, even though they are not selling much there - trying to reduce manufacture for export from CN?

It caught my eye that China files far more (world dominant) patents in the field of alkaloids and plant extracts.  Two comments: 1) they mention this is mostly China claiming their 2000 years of medicines have been IN USE for more than two thousand years (hmmm), and 2) why waste your time with these "inventions" in the USA where many would be ineligible subject matter under section 101

Forward citations of patents by later applications is very low in Asia.  Probably due to language issues.  It is 5 times higher in the U.S.

December 9, 2014

3D Printed Fuel Cells - Well, at Least the Inks  

I can readily imagine how they make anodes and cathodes.  Even, how they could use emulsions or localized drying to get the porosity for adequate surface areas. 

I am not sure how they would prepare the necessary proton permeable membranes with adequate exchange rates.  I can't find a patent application for this.  I wonder when the details will be published.    

December 8, 2014

Patenting is as Easy as Falling Off a Log

We have seen other data lately, but I can not remember.  It seems some sectors (communications?) make up a far higher proportion of the patent issue increase than others.

Considering the amount of subject matter rejections, post grant review problems, and discouraging Court cases recently, I suppose this log chart may go sigmoid soon.

December 7, 2014

CFF Charity Sells Out Royalties on Ivacaftor for $3.3 Billion

Wow.  $3.3 Billion is a lot of money for a drug Ivacaftor with indications for only 5% of cystic fibrosis cases. 

http://www.chemspider.com/Chemical-Structure.17347474.html

The Cystic Fibrosis Foundation must have been collecting huge royalties on the drug, for Vertex to sell them out for this amount. 

Remember Vertex was being run through the mill for the price charged for this drug?  Why was the media so silent about the fact that a big chunk of that money was going to CFF?

December 6, 2014

Previously Secret PTO Policy to Prevent Embarrassment Delays Pioneering Patents

Self centered government out of control again, forgetting they less important than the People.    

The stated policy reasons for the program are pretty bad.  http://hho4free.com/documents/patent_screening_uspto%20memo.pdf  Your application may be sidelined in a Patent Office defensive committee limbo for years if - your case is deemed "controversial or noteworthy", if it may "generate unfavorable publicity" for the PTO, or if you have an "application with pioneering scope".   

If these are the motives they were willing to put into writing, what are the unstated motives? 

Sometimes Applicants are paranoid, and sometimes the Man really is out to get them.  Heaven forbid if you have a breakthrough pioneering invention.   

How could they have done this differently?

December 4, 2014

Just In! Red Wine May Reduce Cancer and Mediterranean Diet Extends Telomeres!

Old news, but fun to hear it confirmed again.  Mechanisms may be unfolding in continued research. 

MMediterranean Diet:

http://www.scienceworldreport.com/articles/19584/20141202/mediterranean-diet-might-help-keep-you-young-study-shows.htm/a>

Red Wine:

http://www.scienceworldreport.com/articles/19636/20141203/could-drinking-red-wine-prevent-cancer.htm

Too bad I drink beer with my Med diet. 

December 3, 2014

HIV Strains Trending Toward Less Virulent Forms in Response to Selective Pressures

This is not the kind of data I expect to see in the normal course of a lifetime.  Most evolution of pathogen populations and host populations takes place over hundreds of years.  Here, we have the fast evolving HIV and the intense selective pressures exerted by human behavior and the pharmaceutical industry. 

Actually, recent data suggest HIV originally jumped into human hosts a hundred years ago from primates.  On introduction, there was no balance and HIV has been unusually lethal and tenacious.  However, eventually the interactions of host and pathogen should normally reach a balance where the virus may be more successful.  Extremely virulent pathogens are typically not very successful.  HIV may have started out too virulent and is trending toward less virulence in humans.   

See the full article at: 

http://www.pnas.org/content/early/2014/11/26/1413339111.full.pdf+html

At first the theory seemed a little flakey to me.  Why would adoption of HIV to more resistant hosts be an advantage, unless the initial compliant hosts were being killed off?  Why would the reduction of viral load from antiretroviral therapy select for Less virulent HIV strains?  

Well, it is true if the host lives longer, more transmission can take place.  And, some of the retroviral drugs act only against active viruses, so the less aggressive HIV may be selected (much the same as with some antibiotics and cancer drugs.). 

So, when will we come into balance with a less aggressive form of HIV?  I doubt a balance will ever be reached, in the "Natural" course of things.  New drugs will change selective pressures.  New treatments, such as a Therapeutic Virus (Looking for research and development partner (US 20140030792 : https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US20140030792.pdf )  may eradicate HIV?

December 2, 2014

Joint Ownership and Inventorship Complications in Patent Rights

All these problems in the article can be avoided with proper contracts - Assignments, collaboration agreements, and joint development agreements. 

Without clear and valid inventorship and preexisting agreements, joint ownership can lead to any number of problems, particularly with unsophisticated "inventors".  For most of my clients, all named inventors have assigned their rights to a common entity (their employer) - a school or corporation).  This avoids the problems stated in the article. 

However, here are a few problems I have seen regarding inventors and owners: 

Applications with inventors added with no actual inventive contribution.  Hot shots that paid for some of the work, or who want another entry in their resume.  This has to be correct by the time of issuance.  If inventorship is intentionally incorrect, it may be considered inequitable conduct on the Patent Office and the whole patent can be invalidated.   

Collaborations between contracting entities where the staff of one entity did not actually contribute to the claims that issue.  Just because ownership is designated by contract, does not mean the application can list improper inventors.  I have had to provide an inventorship analysis in such cases, even though it was immaterial to ownership of the patent. 

One instance that particularly bugs me is a small inventor who had discussions with a large entity before filing an application.  The large entity staff claim to be inventors of the present claims (even though the claims are outside their area of expertise) and have insisted on listing the large entity as an owner Applicant.  Meanwhile, they feign no interest and will not contribute to prosecution costs.  Again, inventorship (controlling ownership since there is no contract) must be verified when allowable claims are identified. Inventorship analysis is not free, and this will be a burden on the small inventor. 

Inventorship determinations can change joint ownership rights.  Don't let ownership get out of your control, or you may be subject to the problems identified in the article, and more. 

November Entries:

November 29, 2014

Big Pharma Dropping Off Patent Cliff

Pipelines.  Not oil, but drugs.  Just because they certain pharmaceutical companies are big, does not mean they are lucky.  Research runs at least 50% on serendipity.  Throwing huge amounts of money into research does not guarantee the next blockbuster.  I believe that lately big pharma research expenditures have not even kept up with inflation.  Often, it is easier for them to spend $100 million on a startup with a phase I drug candidate than to spend $200 million trying to find a candidate from scratch.  This is good news for well directed small companies

A big lesson from the article is that big and small pharma rely almost exclusively on patent position to as a basis for their valuation and to assure compensation in the marketplace.  Small pharma, without even a net profit, is not going to be bought out for $100 million without their patent portfolio in place.

Another lesson is that patents do run out.  After 5 to 10 years developing a drug, a pharmaceutical company may have only 10 years of sales to recoup the research and development expenses.  Because of this, pharma does not have the profit margin the cynics imagine. http://yourbusiness.azcentral.com/average-profit-margin-pharmaceuticals-20671.html.  Even the often quoted profit margin of about 12% is cherry picked data - not including the widespread negative burn rate of struggling small pharma start ups.    

Eventually the hard work and creativity of the researchers become a gift to society (and generics manufacturers.  THANKS. 

November 27, 2014

Parasitic Worms Send Calming miRNA Messages to Host Immune Cells Using Exosomes

Every few months I hear more exciting news about miRNA functions.  Here is a copy of the full article:

http://www.nature.com/ncomms/2014/141125/ncomms6488/full/ncomms6488.html  

Apparently, the gastrointestinal nematode parasite (Heligmosomoides polygyrus) incorporates miRNAs into vesicles (exosomes) derived from host membranes to assemble a Trojan horse for entry into host immune system cells.  The miRNAs are homologues to mammal host miRNAs controlling immune responses so they can send a false signal local immune cells not to attack. The exosomes fuse and discharge contents through non-specific membrane fusions not requiring peptide interactions.  Such a simple way to avoid host immune responses.  What other pathogens use similar strategies? 

The authors enriched parasite-derived exosomes by centrifugation and applied them intranasally to mice.  Then, when the mice were exposed to inflamatory Alternaria mold extract the normal eosinophilia was sharply reduced.  A treatment for allergies or asthma?

November 25, 2014

University OTTs - Trolls or Just NPEs?

Even the most successful university technology transfer office (OTT) does no better than $2 for $1 spent administering the portfolio.  The data are incomplete ( http://www.insidepolitics.org/brookingsreports/University_Tech_Transfer.pdf ), but I suspect many OTTs barely pay their way.  Of course, the $2.5 billion received by OTTs will never make a big dent in the $90 billion the Feds spend on academic research, but that is not the point.

Some say it would be a good idea to find grants based on patents issued instead of on journal articles published.  Sorry to say, funding based on patents granted would probably increase the number of patents with worthless claims.  At least with a publication, some independent journal (maybe not a Chinese journal, but that is a different story) found value and prestige in the article.   

I believe the real success story is when university scientists exercise their option to practice their inventions (where the university has found no licensee) and they start new businesses. 

Trolls?  Not universities.  NPEs (Non-Practicing Entities).  I do not think there are many examples of universities suing companies just to settle for the value of avoiding litigation.  More pointedly, most universities do not have the assets to win a battle of attrition in the Federal Courts.

November 21, 2014

Who Needs Bone Marrow Stem Cells When You Have Nails?

Interestingly, after loss of a nail (e.g., due to trauma; raise your hand if this has happened to you), the shift between skin and nail production is signaled by bone morphogenetic proteins (BMPs).  At first I found this surprising because skin and nail are ectoderm origin, and bone mesoderm.  However, come to find BMPs are a family of growth factors than can influence tissue architecture throughout the body. 

BMPs are available clinically, e.g., to aid in healing of spinal fusions and oral surgery.  Apparently, certain members of the BMP family can be purchased for off label use (80% are sold off label), even over the counter.  The negative side effects of these usages are not well understood.  I wonder if they give you thicker more luxurious nails?

University of Southern California - Health Sciences. "Nail stem cells prove more versatile than press-ons." ScienceDaily. ScienceDaily, 21 November 2014.

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November 19, 2014

Bioequivalence Testing Continues After Marketing to Identify Statistically Different Generics

Here are some administrative processes I was not familiar with in the field of small molecule generic drugs.  Generic copies of a drug against attention deficit hyperactivity disorder (ADHD) are suspected of not being bioequivalent.  The FDA has put them on probation, of sorts.  The therapeutic equivalence (TE) rating for two generic products were changed from AB to BX, allowing continued subscription, but not with equivalent status required by most pharmacies and insurance carriers.  See - http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm .

Apparently, the extended release of the generics is different.  The generic makers have 6 months to confirm bioequivalence, or exit the market.  Manufacturing a copy delayed release may not be as simple as formulating to a similar in vitro stir dissolution assay.   

November 18, 2014

Turmeric - The Solution to All Problems

I wrote a patent application concerning use of turmeric extracts in wound healing when I first started doing patent prosecution.  Ever since, I can't help but notice all the benefits it is said to bestow (it's like not noticing how many VW cars there are until after you own one).  

Here, turmeric in the morning provides better working memory to pre-diabetics in the afternoon.  

No proposed mechanism is suggested.  Let's see, curcumin reduces oxidative the cholinergic neurotransmitters (http://www.ncbi.nlm.nih.gov/pubmed/19221412 ).  Or, how 'bout this - turmeric reduces blood glucose levels?  (http://www.emaxhealth.com/1275/turmeric-improves-blood-glucose-type-2-diabetes )  Hey, wait a minute, doesn't the brain need glucose to think?  But, not if there is too much glucose.  (http://www.medicalnewstoday.com/articles/267727.php ).

Who says you have to do research to solve problems?  In any case, you CAN solve all problems with turmeric.  Just don't spill any on your kitchen floor; you will never get the yellow stain out.

November 17, 2014

Do You Want Super Sized Acrylamide with Your Fries? 

Even though the genetically modified potato would be healthier and suffer less spoilage, McDonalds refuses them based not on science, but the negative media atmosphere generated by the politically and emotionally (paranoid) driven press.  I guess they prefer neurological symptoms, decreased fertility, and cancer. 

See the application Low Acrylamide Foods: https://www.google.com/patents/EP1974039B1?cl=en&dq=acrylamide+inassignee:simplot&hl=en&sa=X&ei=4HhpVLnjB46fyASQpoC4Cw&ved=0CEkQ6AEwBg

Asparagine and reducing react in the presence of heat to form acrylamide (neurotoxin familiar to lab technicians that used to pour their own gels for polyacrylamide gel electrophoresis (PAGE)).   The constructs inserted into the potato down-regulate expression of asparagine synthetase genes or up-regulated asparaginase to reduce asparagine in the starchy tissues.  The result is a food plant with no unnatural nutritional elements, but reduced in free asparagine amino acid. 

Seems a little snooty for those selling or eating a salty oily food, famous as a source of the obesity epidemic, to turn up their noses at a safer product.  I was going to say they get what they deserve, but actually - shame of the ignorant media.   

November 16, 2014

Crazy Combination of Microfluidics, FRET/Fat FACS Identified Pathogen Bacteria in Microliter Blood Samples

A cool combination of some old tricks.  A bit of a fluorescent resonance energy transfer (FRET) probe, with some nice diluting water in oil microfluidics, read in a fat fluorescence-activated cell sorting (FACS) that passes by the detector in a vortex to read batches of particles at once, instead of waiting for them to pass by one at a time. 

I think the most interesting part is the DNAzyme construct that sets up the FRET detection for specific bacteria of interest.  The DNAzyme constructs can have different probe sequences triggering different fluorescence wavelengths so that several different bacteria can be screened in the same assay.  See details at:

http://www.nature.com/ncomms/2014/141113/ncomms6427/full/ncomms6427.html

This is a great idea, whose time has come.  I get tired of waiting around for culture plate pathogen identification.  So too are the doctors who often skip culture entirely and just make a guess as to the most likely pathogen. 

November 14, 2014

Even "Reasonable" Little Guys Can Get Hurt in "Loser Pays"

The big guys are essentially self insured, and the little guys have no insurance.  That is, the big guys routinely, and continuously, experience demand letters (reasonable and not).  They win some and lose some.  On the average, they have a consistent cost of business.  And, if they are aggressive, on the average, their costs go down due to their earned reputation for willingness to fight a war of attrition.   

Meanwhile, the little guys have to take each of their rare cases more seriously.  Even when they are right, and may even win court costs, there is a chance that if they lose the case they would be ruined by the years of their own costs compounded by the crushing debt of suddenly having to pay the fees of the prevailing party.  Would you take a one in 20 chance of losing your business over an infringement lawsuit?  A presumption of fees to winners promises eventual relief if they win, but devastation if they lose. 

The bill probably will not become law.  See HR3309 estimated a 36% chance of being enacted: https://www.govtrack.us/congress/bills/113/hr3309/text  .

285.Fees and other expenses

(a)  Award

The court shall award, to a prevailing party, reasonable fees and other expenses incurred by that party in connection with a civil action in which any party asserts a claim for relief arising under any Act of Congress relating to patents, unless the court finds that the position and conduct of the nonprevailing party or parties were reasonably justified in law and fact or that special circumstances (such as severe economic hardship to a named inventor) make an award unjust.  

So ... The presumption mentioned in the article is not a rebuttable presumption that the loser must pay fees, so much a requirement that the loser's case be reviewed to see if it was unreasonable.  And ... the door remains open for the judge to decline to order fees, where it would ruin the small party. 

If reasonably applied, the law may not be a disaster (not that I am for it).  For example, I usually do not appeal patent application rejections, unless I know my case is more than reasonable, reducing the chance of the rare crazy decision against me.  The same should be practiced in infringement suits.  If your case is somewhat doubtful, don't sue (if you had, there is a significant chance the Court would find your case unreasonable and order payment of defendant fees).  If you have a great case, the likelihood of both losing and having your complaint held unreasonable is vastly reduced. 

November 12, 2014

Tesla, the Long Story

The Tesla team was smart to break the mold and show case the inherent advantages of electric propulsion (instant torque, low center of gravity).  I suppose part of the success was a freak in timing: advanced materials, more efficient Li-Ion batteries (from personal electronic devices ) became available, better power control systems, and the doomed "zero emissions" standard in California all came together. 

I did not know the basic chassis was based on the Lotus Elise. 

Living in the SF Bay area, I am quite happy they took over the old Numi motors manufacturing plant, and brought back some manufacturing jobs to the region.  Too bad it made no sense to also build the giant battery factory (giant factory, not giant batteries) here, but in Nevada. 

Tesla gives free access to its patented technology.  So what are their patents anyway?  Batteries, I guess.  Nothing new about the chassis or power train, it there?

November 11, 2014

Another DNA Assay Bites the Dust?

I do not see a lot of hope for this patent in light of recent Court holdings.   Claim 1 of the patent U.S. 6,258,540 is directed to amplifying and detecting the presence of a paternally inherited nucleic acid of fetal origin in a maternal blood sample.  Generic embodiments of detecting natural subattances in their natural environment do not seem to pass the Patent Office lately. 

For example, in Myriad, even synthetic DNA strands of a natural sequence were found ineligible for patenting.  In  Mayo v. Prometheus, the correlation of a UNNATURAL metabolite to drug efficacy was held to be an ineligible natural phenomenon (crazy). 

Here, how could the natural phenomenon of unmodified fetal DNA in maternal blood pass such a high eligibility standard, linked only to generic detection methods in the claims?

Novenber 10, 2014

Another AIDS "Cure" - Requires CRISPR Attack of Patient-Harvested Immune Stem Cells 

HIV enters T cells through chemokine receptor type 5 (CCR5), apparently found unnecessary to adequate functioning of the T cell.  The gene can be very selectively knocked out using a bacterial CRISPR/cas (clustered regularly interspaced short palindromic repeats) system, normally used to cut bacteriophages in bacteria "immune systems".   

HIV patient blood stem cells are harvested, treated, and returned.  The CRISPR/cas system does not cause any random mutations in the stem cell.  Even if the knock out treatment is not 100% efficient, those cells converted to CCR5 negative can take up residence in the patient's bone marrow and provide a HIV incompatible line of T cells. 

This system is a little more complicated to practice than the previously noted therapeutic virus (TV) system (https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US20140030792.pdf ), which would theoretically require only administration of the TV to the patient.  However, this system appears to be a promising option to rebuild immunity in AIDS patients.     

November 9, 2014

Illegal Photography of Public Buildings in Europe

Seems a little absurd that someone can place a structure in the cityscape and have the nerve to tell people they can no longer point their camera that way. 

At first, I thought this article may be about security.  I remember climbing a mountain outside Seoul KR years ago and being warned not to take any photos of the city.  Now with all the satellite images, it hardly matters.  (Remember when the street maps of Moscow were all drawn out of scale so they could not be used to target missiles?) 

Reminds me of the old legal case of product placement in movies.  A movie producer was sued for including a retail product (like a VW car, or something) in the movie.  The U.S. Federal Court found for the defendant's right to include incidental images of products in movies.  Otherwise, how could one shoot a movie?   Funny, now the retailers have to pay producers to include their product in a movie.  . 

Same with the Eiffel Tower.  I am going to send Paris a bill for product placement of the Tower in my vacation slides. 

November 8, 2014

Vascular Tissue from FibroBlasts Treated with an RNA and Growth Factor(s?)

The unpublished work apparently includes a step of freaking out fibroblasts with a so-called small molecule poly I:C (polyinosinic:polycytidylic acid) double-stranded RNA that gives the impression of a virus attack.  Then the fibroblasts were  treated with growth factors, such as vascular endothelial growth factor (VEGF, which binds to the host cell receptor TLR3) to miraculously not only transform some fibroblasts into endothelial cells, but creates an environment wherein vessel structures anastomose in functional relation with previously existing with normal vessels, e.g., to improve circulation in a mouse model.  (Sorry about the long sentence, but it is so exciting.)  Introduction of the treated cells into a wound could bridge gaps and aid healing.    

Now, I know why they call them fibroBLASTs?  Both the fibroblasts and resultant endothelial cells are of mesoderm germ layer origin.  So, it is not too big a stretch. 

Great work.  I am amazed how certain seemingly simple techniques sometimes have such complex results.   

November 7, 2014

Therapeutic Virus Can Only Reproduce in Infected Cells While Encoded miRNAs Neutralize Resident Pathogen - A Cure for AIDS?

            The therapeutic virus (TV) is a modified form of the pathogenic virus.  The TV is non-infectious to normal cells not infected by the pathogenic virus. This is achieved by selectively mutating residues in an active site of one or more of the enzymes essential for the propagation of the TV.  The TV is only saved if infections virus is present to donate the essential enzyme.  On the other hand, the TV encodes an miRNA that disables the infections virus. 

            The TV has the ability enter all normal host cells of the pathogenic virus.  For example, any modifications to the enzymes of the TV do not impart significant changes to the three dimensional structure of the enzymes thus maintaining normal packing within the capsid.  Because the TV is missing enzymes essential for the propagation, e.g., no functional reverse transcriptase (RT) and/or integrase enzymes, it can not reproduce without the presence the enzymes from the pathogenic virus in that cell. 

            The TV has pre-miRNAs inserted into its UTR region.  In the case of a TV for HIV-1, the miRNA can be inserted after the stop codon of the Nef domain and become part of the host genome in the infected cell.  When the TV genome is replicated, mRNAs are produced for the pre-miRNA portions and processed by the dicer and drosha enzymes.   The resulting miRNAs bind to the transcripts of the infectious virus and interfere with the production of other key viral enzymes necessary to the propagation of the infectious virus.

            In the TV, the miRNA binding target sites are modified so the miRNAs do not interfere with the production of the TV.  Therefore, while the reproduction of HIV is blocked by the TV miRNA, the TV can be normally packaged and secreted.  The secreted TV can then infect more cells to propagate their beneficial function.  The production of the TV continues until all the infected cells in the patient die. 

            The therapeutic virus that can only grow and reproduce in cells previously infected by pathogenic target virus.  The TV is harmless to uninfected host cells.  However, the TV encodes an miRNA destructive of the targeted infections virus resident in the same cell but not to the TV.  The TV is self limiting to reproduce only, e.g., in otherwise HIV infected cells, where is reproduces itself, while destroying the HIV. 

Similar concepts can function against other viruses, such as Hep C.   Applicant is interested in partner to collaborate in further studies.  See Therapeutic Anti-Virus VLPS US 20140030792 A1,   Application number 13/940,122      Contact Baker@BioPatent.com

November 6, 2014

Not the First Bra, but First Patented "Improvement"

The word brassiere was well in use by the time of the patent, and the specification discusses improvements thereof.

Not the most comfortable looking design (not that I would know). No contours to the cups. Probably would sell well, though, in the upcoming flat chested flapper era.

See original patent at:

https://www.google.com/patents/US1115674?dq=US1115674&hl=en&sa=X&ei=wIVaVL3KEIKwogT-1YKICQ&ved=0CB8Q6AEwAA

Surprising Progress in Battery Energy Storage

The NiCd and Ni metal hydride batteries seem to have saturated their theoretical maximum energy density.  Can the Li-ion batteries continue on for another doubling?  After that, what is left?  You can not get much lighter and concentrated than LiCoO2 , and the electrolytes can only be so concentrated. 

Seems the next step will have to be some process wherein reactants are refueled, e.g., hydrogen. 

Anyway, the progress in energy density is more significant than I would have guessed. 

November 5, 2014

Fortifying Your Applications Against the (Current) PTAB Onslaught

Fortifying Your Applications Against the (Current) PTAB Onslaught

This was an easy to read and informative article on how to strengthen applications for possible review at the PTAB, as it now exists.  The good news for me is that most of the practices to strengthen an application in the PTAB environment are the same as I practice in the context of routine prosecution.   

Everything has risks and benefits.  I have heard some writers suggest it is a bad thing to include a Background of the Invention, or even a Definitions section.  There is the risk of admissions or narrowing definitions, but these can be avoided with care, or traded for a stronger application in the context of the invention intended for market. 

It seems like there has been a move lately to draft initial claims more focused on the intended market.  I have a habit of tailoring independent claims to broadest scope avoiding known art, then backing them up with more focused dependent claims.  Lots of claims in the initial filing, but reduced claims before excess claims fees kick in.  I had not considered annoying Inter Partes Review filers with a large array of dependent claims.  For my clients, this would generally not have a good cost/benefit ratio, since IPR is expected to be rare.  But excessive claims may be something to be considered, depending on the nature of the subject matter and market. 

The biggest problem I see in these strategies is they live in the present and the rules keep changing retroactively far down the line.  Structuring my applications now for the present environment, will I give up claim scope in the more patent friendly environment of 2020?

First Strike From Trademark Empire

Seems certain trademark Kingdoms aggressively dispute, more as a warning to others in the future than to stop a current new mark.  Lucas would probably be willing to spend more on this dispute than the value of any maximum losses they would theoretically incur.  But, Lucas aggressive opposition behavior may stifle future  unwanted "nods" to their trademark Empire.  

Telomerase Arond the Clock

Circularized yeast chromosomes were opened with a telomerizing inserts at various positions.  Interesting all remained viable but for where essential genes were too close to the new telomers.

Now constructs can be opened anywhere to present more eukaryotic linear structure. 

November 4, 2014

Another Challenge to Patentable Subject Matter - Stem Cells Challenged in SCOTUS

I thought it was overblown that Dr. Loring, the stem cell patent opponent at Scripps, stated " it's very important to just wipe this thing off the books".  Well, yes and no.  The patent is a "thing", but maybe there is no rush to get it off the books.   

See SCOTUS Petition at:

http://www.consumerwatchdog.org/resources/consumer_watchdog_petition103114.pdf

"Loring has said other qualified scientists could have isolated the cells with methods used for finding animal embryonic stem cells, so the advance was obvious.

Moreover, embryonic stem cells are a product of nature and therefore not patentable according to a 2012 Supreme Court ruling, they say."   

The methods do appear routine, maybe even for 1995 - monitor and mate female primate and harvest blastocyst embryo by flushing, disaggregated cells onto fibroblast feeder cells, grow, freeze, and store.  See, the issued patent:  http://www.google.com/patents/US7029913  .  It is possible the methods were new, and arguably non-obvious, however this is not what is claimed: 

1. A replicating in vitro cell culture of human embryonic stem cells comprising cells which (i) are capable of proliferation in in vitro culture for over one year without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.

OK, what have we got here?  A generic composition claim without structure and distinguished  only by desired characteristics.  How did this get through the patent office, even in 2006?  The cells probably inherently existed (burden on Applicant to prove otherwise), so they are not new (failing Title 35 § 102 and 103 requirements).  The claim is to all cells with these characteristics, even though they only show a couple of similar ways to obtain them, therefore the claim fails to meet the standards of enablement and written description (Title 35 §112) requirements.  The cells appear to be in an unmodified natural state (unless the process, not in the claims, significantly modified them in some way), so they would fail patent eligibility under Title 35 §101, even under the pre-Myriad standards.  The patent is a "thing". 

Best case, the particular method of isolation and maybe a product by process (MPEP 2113 - http://www.uspto.gov/web/offices/pac/mpep/s2113.html) claim should reasonably have issued. 

All that said - what is all the hullabaloo about?  The priority date is 1995 to a Continuation in Part application and Continuation application filing date is 2001, so there can not possibly be much time left in this patent in any case (2015 max?).  I guess this is just one more chance for a bad case to make more bad law at the Supreme Court. 

 November 3, 2014

Easy Overview of Eligible Material for Patenting

Here is relatively easy to understand overview of patent eligibility challenges for inventions in the biosciences.

It is more important than ever to support and claim "something more" than natural phenomena.  You can only claim what is disclosed in your application.  So, there must be a description of the aspects of the invention (composition, device and/or method) in the application that distinguishes it from what is found in nature. 

In biotech, it can often be easier to patent claims directed to biomolecules if, e.g., they are modified away from the natural sequence, or used in a way that focuses on solving a problem in a non-obvious way. 

November 2, 2014

PTO Crowd Sourcing Novelty Searches

At first glance, novelty always seems such a straight-forward issue to me.  But I am not the one who has to do the search. 

The PTO seems pretty good at searching patent and journal databases.  However, there are a lot of publications (and offers to sell?) not so easy to find.  Maybe Google will have some suggestions.

Benefits of Cell Cluster Metastatic Growth Outweigh Mobility Disadvantage?

Benefits of Cell Cluster Metastatic Growth Outweigh Mobility Disadvantage?

It makes sense that tumor cell clusters would be more successful in metastases, and that plakaglobin (gamma-catenin) would have something to do with the adhesion necessary for clustering. 

 Working against metastasis is the fact that most metastasis involve migration in and out of vessels through tight endothelial layers.  It is hard for me to imagine clusters accomplishing this feat. 

 For example, try to imagine a cluster of cells doing THIS:

http://labroots.com/user/account-file/view-video/type/public-wall/id/822

November 1, 2014

Malaria Vaccine is More Than Just a Me Too Vaccine

It is hard to criticize a malaria vaccine that prevents illness in half the children. One would hope that even those that come down with the disease will have a milder form. If the kids can make it to an older age, their chances of survival go way up. And this is the first vaccine. More to come later, I hope. Thanks Gates Foundation.

October Entries:

October 31, 2014

Broadest Reasonable PTAB

My biggest day to day problem with the Broadest Reasonable Interpretation (BRI) standard is that it is typically unreasonable.  Often it is unreasonable interpretation of terms in ordinary context.  Most often, the BRI as asserted by Examiners, fails to acknowledge a key part of the standard - the BRI In Light of the SPECIFICATION. 

Will the PTAB also over extend the BRI by ignoring the context of the specification?  I doubt they will not prepare a fact supported construction table (considering the file wrapper?).  Hopefully, they will at least not go on a "gut feeling".  

NPEs Can No Longer Afford to Fight

When I was a scientist, I ran my experiments changing only one variable at a time.  It seems the Courts and Congress are trying to run an experiment changing three variables at once.  No guessing how it will come out and what it will mean.   

One thing is for sure, the pendulum has swung too far.  Now that the trolls and mean ol' NPEs are in their place, do you suppose the media will start singing the praises again of the noble inventors changing the world from their garages? 

October 30, 2014

New EPO Guidelines Published

Although we are a U.S. firm, we instruct a lot of prosecution at the EPO. I have downloaded the new Guidelines.

http://documents.epo.org/projects/babylon/eponet.nsf/0/7D528617043B66F5C1257D62003F5DB4/$FILE/guidelines_for_examination_2014_preview_en.pdf

 It is great that the changes are so clear to see in the mark up.

My favorite part is the Inventive Step analysis.

A thorn in my side has been "added matter" rejections during claim amendments. I couldn't find a good discussion of that. Hmmm. Where is it?

-----------

On further review I see Art 123(2) - The European patent application or European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed.

From there, I wonder where they get - the content of the application as filed must not be considered to be a reservoir from which individual features pertaining to separate embodiments can be combined in order to artificially create a particular combination" ? Part H, ChV 3.2.1

I always thought teaching two generic elements, each with a variety of species, would teach the smart people skilled in the art that any of the combinations were considered inventive alternatives.  The combinations, expressed logically (without having to list each combination separately) should be considered "unambiguously derivable"; but that is just me.  For example Teaching A1 or A2 and B1 or B2 should be considered to teach 4 alternatives. 

However, the new section at Part H, ChIV 2.3. states "When assessing the conformity of the amended claims to the  requirements of Art. 123(2), the focus should be placed on what is  really disclosed to the skilled person by the documents as filed as  directed to a technical audience. In particular, the examiner should  avoid disproportionally focusing on the structure of the claims as filed  to the detriment of the subject-matter that the skilled person would  directly and unambiguously derive from the application as a whole."  This gives me hope that the EPO will realize that just because an inventor uses convenient means to describe combinations and permutations does not mean the combinations are not taught to one of skill in the art. 

We will see if the EPO will ultimately see the objectively taught logic of "or" and "and".   

October 29, 2014

Soft Where? - in Patents.  A Basic Overveiw of Software Patents

Here is a basic overview of software patents.   

I was surprised at the small percentage of IT companies that actually bother to patent their software.   

The funny thing about software patents to me (mostly working in molecular biology/medical devices) is that subject matter is such big deal in software.  From what I see in the structureless result oriented phraseology of software claims, the bigger issue should be section 112 enablement and written description.   

What software really needs is a copyright with a Doctrine of Equivalence, I think.

October 28, 2014

Ebola Vaccine Balue Not In Annual Sales, But In Peace of Mind

Ebola Vaccine Value Not In Annual Sales, But In Peace of Mind

While Influenza may have a multibillion dollar annual market, Ebola would usually have only a multimillion dollar market.  Still, the benefit of vaccinating people endemic areas is multibillion.  So, although private businesses can not rationally invent billions, it is good that governments are willing to subsidize. 

Once a vaccine is in place (and it will be, e.g., since Ebola does not present many of the problems inherent in HIV vaccines), West Africa could be generally protected and/or outbreaks could be promptly encircled with a multilayer ring of vaccinated populations. 

SScare the West enough and we will spend.  Now, how about malaria? 

October 27, 2014

An miRNA Influencing Binge Drinking

Now ... to identify the control system for the miRNA. Hmmm, can you make an miRNA that cleaves a miRNA?

-----------------

I have been asked on the side why I would want to cut the miRNA with another miRNA. Actually, it was intended as a joke. I have a nasty habit of throwing in a joke on serious sites without using a smiley emoticon ;) 

In many instances, I believe miRNAs cleave target mRNAs (e.g., encoding BDNF). I would not be surprised if there are subclasses of miRNAs that attack other miRNAs. However, this may not be a preferred mode to solve alcoholism, since it would require direction of an expression vector into the brain of a patient. 

October 26, 2014

How Can We Detect Differences in Licensed Biosimilars?

It seems each state has the option of modifying the Federal mandate to allow the biosimilar option.  Several states believe there would be a net benefit to require the prescribing physician be notified if the patient is given a biosimilar over the name brand drug prescribed. 

How similar is "biosimilar"?   Biosimilar means that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”  That is easier said than done, but is probably successful in the majority of cases.  See:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf  

The manufacturer of a proposed biosimilar product will likely have a  different manufacturing process (e.g., different cell line, raw materials, equipment, processes,  process controls, acceptance criteria) from that of the reference product and No Direct  Knowledge of the Manufacturing Process for the Reference Product.   

I worked designing purification processes for recombinant peptide therapeutics for many years.  There are many routes to a purification, and the product will never be exactly the same (lyse cells, precipitate proteins, affinity column, size exclusion, concentration/formulation; or, lyse cells, affinity column, hydrophobic interaction, size exclusion, concentration/formulation).  The active peptide and impurities would be different all along the way.  The product Will be different, particularly if there is peptide refolding of covalent modifications, such as pegylation involved. 

Should the prescribing doctor be informed?  The whole cost/benefit analysis seems to depend on informatics.  Notice of a switch to a biosimilar seems like an administrative burden, and most doctors will probably ignore or be unaware of the notice.  On the other hand, the biosimilar manufacturer may be required to provide clinical data, but the statistics may not be strong.  Once the biosimilar gets out for full scale use, minor differences in efficacy and side effects may become detectable, but only if observations are systematically received from the clinical environment.

Data from notified doctors would probably be sporadic, anecdotal, retrospective, and include their biases.  My best guess is that it may be more effective for the information to be systematically  retained in databases and a comparison of name brand and biosimilar compared in the whole population of outcomes.  But it may not hurt to inform the doctors, if they have time to listen. 

October 25, 2014

Attack the Genius ... I mean the Genus

It is fun to be overly simplistic, so here I go ...

The main problem is a vicious cycle of government and media feeding off each other identifying "problems" (real or imagined), and "doing something" whether it is directed to a problem, or not. 

Often too, the problem is generic laws attacking specific problems. 

October 24, 2014

Despite Media Hype, Patents (and Applications) Still Offer Advantages to All

Thomas Jefferson would spin in his grave to hear all the folks suggesting that "patents stifle innovation". 

Small companies may feel like patents are blocking their progress, particularly in crowed or high tech fields.  For example, a high tech device may include 50 patented technologies; no one company owning more than 10. A small company with just one relevant patent can not even practice their own invention because of the other patented elements in the device. Worse yet, their patent may be to a specific improvement to a active pioneer patent owned by another (however note neither can the pioneer practice the improvement).   

Ironically you hear large companies proclaiming the loudest that patents are stifling.  They may be annoyed, but they can practice in the field by using their portfolio of defensive patents.  Mutual Assured Destruction can ensue if one big guy sues another for infringement.  "If you sue me based on your patent '789, I will sue you for your infringement of my patent '345 in this field, and for your infringement of my patent '567 in an entirely different field!"  If the big guys do ultimately get in a legal fight, they typically arrange confidential settlements, so the next guy will not know the exposed strengths and weaknesses of each parties positions.  Trial to verdict is not the norm. 

So, what about the small guy?  With a patent (or application) in hand, you can approach the big guys, even without an NDA.  The big guy may buy you out.  But if they try to steal your patented ideas, you at least have the law on your side.  No amount of fancy attorneys can change the facts or the law.  They may try to win a battle of legal attrition, but the Federal Courts have shown more of a propensity lately to award legal costs to the winner. 

All that Big versus Little stuff aside ...  Patents, and even applications, can create uncertainty and a major barrier to entry for competitors.  You never hear the story about the cat that did not get caught in the tree.  How many competitors elected not to enter a market just because their main competitor would have an advantage protected by a patent? 

R&D Cash Flow at Amgen?

This seems really strange.  The suggestion is that Amgen should split the R&D group from the manufacturing and sales? 

R&D, even at Amgen, is highly unpredictable.  You can not force serendipity.  Moreover, the only asset is the intellectual property and the "people".  But this has no cash flow. 

Sounds like a bad idea, unless there is something I am missing. 

Evidence Suggests There is Not a New Patent Litagation Problem

The main problem is a vicious cycle of government and media feeding off each other identifying "problems" (real or imagined), and "doing something" whether it is directed to a problem, or not. 

October 23, 2014

What Drugs are Hiding in Your Micro-Biome?

I always thought the balance between normal micro-biome members would be found in the microenvironments they create, e.g., inhospitable to other organisms. Interesting that a "new antibiotic" interacting in a human habitat.

I have read a lot of micro-biome research lately.  Lots of correlations.  What would be more interesting would be more data on proof of causation. 

---------

October 22, 2014

Children of Mayo are Not Routine and Well Understood

It seems the Court rulings (especially the SCOTUS) have been based on gut feelings that the patents were inappropriately broad.  Then, subjective (not subject to ready scrutiny) bases for rejection were fabricated in non-fact-based obviousness analysis to "justify" the desired outcome.  Too bad the presented analyses are now affecting a range of different cases in unforeseen ways.

I used to think section 103 arguments were subjective, but in comparison to 101 lately, 103 incorporated structure/function, recognized result effective variable, and motivational arguments seem down right objective. 

October 21, 2014

Desire of Great Charity Does Not Take "Property" Out of IP

Doctors without Boarders is great.  However, the importance of enabling a charity to give cheap drugs is immaterial to intellectual property rights and provides only a short term benefit. 

Regarding the "novelty and inventiveness" requirement in India.  It seems strange that improvements are not considered in isolation on their merits.  That is, if the improvement is a new drug, the standard of novelty and inventive step is different than when the improvement is to a new and inventive change to a drug formulation. 

When the original drug patent expires, everyone is free to make and sell the drug.  What Is The Problem?  If someone develops an improved formulation, they can patent that improvement, without stopping use of the expired formulation.  And, if the new  formulation improvement were so obvious (and allegedly not inventive), why didn't the Indian pharma companies make the improvement themselves before the western companies taught the new formulation in their applications? 

There is no such thing as "evergreening".  Patents expire.  New and inventive improvements can be developed through new research later and the improvement has a separate patent application.  Again, this does NOT prevent anyone from practicing the expired parent patent.   

Why must those, apparently feeling guilty for taking something that they do not own, justify the taking by vilifying the owner?  Again, when will the takers ever say Thank You? 

October 20, 2014

Patents That Kill - Researchers Allegedly Divert Away from Cancer Cures

Patents that kill - there are said to be 30 times more clinical trials for recurrent cancer drugs than for preventive drugs.  The author suggests researchers divert funds away from cures and prevention to the more hopeless indications.  No clear motivation is given.  How about this - recurrent patients are more willing and appropriate for experimental drugs. 

It is notable that prevention of cancer is a more generic idea and would have more focused strategies than attacking each of the various cancers specifically.  Further, I suspect the author's data ignores research in the fields most important in the prevention of cancer.  Prevention of cancer is not a new pill, but a social cure for smoking, drinking and over eating.   

Old story, but controversial.  What do you think?

October 19, 2014

NGS Detects Exome Abnormality in 25% of Patients with Suspected Genetic Disorder

The next generation sequencing (NGS) method is not new, only the mode of data analysis.  The Illumina HiSeq next generation sequencing technique was used, wherein even rare sequences are first amplified in a bridge cloning scheme on a solid support.  Next, a polymerase sequentially adds blocked fluorescent NTPs to any clone on the solid support requiring that NTP.  Fluorescence data for each clone location on the solid support is collected.  The whole solid support is deblocked before the addition of the next different NTP to the whole solid support.   

The actual article is available at:

Clinical Exome Sequencing for Genetic Identification of Rare Mendelian Disorders. JAMA, http://jama.jamanetwork.com/article.aspx?articleid=1918774

The technique allows redundant sequencing of the patient's sample, so each exome may be sequenced hundreds of times.  This allows detection of patients who only carry the mutation in a small percentage of their cells (low-level mosaicism). 

I was wondering why the researchers focused only on the Exome of peptide encoding sequences.  The HiSeq is quite capable of detecting any number of sequence variations at introns and exons.  The exon focus is probably due to the legacy of Mendelian clinical data including only mutations in proteins.  In any case, 25% of the patients with unexplained conditions presented a diagnostic mutation.  87% of the detected mutations were de novo in the patient; some somatic. 

The adverse side effect of whole-exome sequencing was about a 2% rate of suspected nonpaternity by at least one parent. 

October 17, 2014

Notice Pleading of Patent Infringement Gone - for Pro Bono and Trolls 

The judicial Conference has eliminated the Rule 84 asnd associated Appendix forms.  http://www.insidecounsel.com/2014/09/22/the-judicial-conference-of-the-us-makes-small-rule

Patent trolls will no longer be able to blindly shot-gun Complaints against any number of Defendants (nor will pro bono Plaintiffs be able to simply file).   

Fedreal Rules of Civil Procedure - Forms:

The forms in the Appendix suffice under these rules and illustrate the simplicity and brevity that these rules contemplate. 

Here is the form for pleading patent infringement: 

COMPLAINT FOR PATENT INFRINGEMENT

1.         <Statement of Jurisdiction.  See Form 7.>

            <a.  For diversity-of-citizenship jurisdiction.>   The plaintiff is [a citizen of State A] [a corporation incorporated under the laws of State A with its principal place of business in State A].  The defendant is [a citizen of State B] [a corporation incorporated under the laws of State B with its principal place of business in State B].  The amount in controversy, without interest and costs, exceeds the sum or value specified by 28 U.S.C. § 1332.

            <b.  For federal-question jurisdiction.>  This action arises under [the United States Constitution; specify the article or amendment and the section] [a United States treaty; specify] [a federal statute, ___U.S.C. § ___].

            <c.  For a claim in the admiralty or maritime jurisdiction.>  This is a case of admiralty or maritime jurisdiction.  <To invoke admiralty status under Rule 9(h) use the following:  This is an admiralty or maritime claim within the meaning of Rule 9(h).>

2.         On <Date>, United States Letters Patent No. <__________________> were issued to the plaintiff for an invention in an electric motor.  The plaintiff owned the patent throughout the period of the defendant's infringing acts and still owns the patent.

3.         The defendant has infringed and is still infringing the Letters Patent by making, selling, and using electric motors that embody the patented invention, and the defendant will continue to do so unless enjoined by this court. 

4.         The plaintiff has complied with the statutory requirement of placing a notice of the Letters Patent on all electric motors it manufactures and sells and has given the defendant written notice of the infringement.

            Therefore, the plaintiff demands:

            (a)        a preliminary and final injunction against the continuing  infringement;

            (b)        an accounting for damages; and

            (c)        interest and costs.

Date:  <Date>  <Signature of the attorney or unrepresented party>

________________________________________

<Printed name>

<Address>

<E-mail address>

<Telephone number>  [END]

All one had to do was fill out this form with a generic allegation to state an initial case.  This helped small inventors who could not easily afford counsel.  Like so many other things, because some abuse opportunities, they are lost to all.  The good news is that the initial quality of pleadings must improve - minimum notice pleadings are gone. 

October 15, 2014

Damage to Old Mom Mitochondrial DNA Can Be Passed to Next Generation

The article is a little fluffy, but has some interesting points.  In hindsight it does not seem surprising that the rate of mutated mitochondrion genes raises in the eggs of older women.  It interesting to see confirmation.  However, I do not see how this helps in educating older mothers.  The information in generalized and of no specific use with regard to a particular woman or a particular fetus (unless probabilities seem high enough to justify sampling and DNA analysis).   

And, the mutations are generalized.  Rates of mutations are higher with age, but not for any particular gene.  So, I don't see any big benefit in useful information to mothers.

Still the part about the mitochondrial DNA bottle neck was interesting.  I would like to know more about how mitochondria keep their genes fresh over the generations. 

The Cost of Restricting Patentable Biotech Subject Matter

It may be reasonable to deem a natural sequence, correlation, or even an expert system to be non-eligible subject matter.  It is pushing it to deem analysis of a natural phenomenon to be non-inventive (obvious).  Now, I suppose it would be deemed obvious to discover a sequence, elucidate a correlation with a disease state, and develop a clinical dataset to direct best practices - three previously unknown things, in combination, that are obvious all together.    

The policy basis in the Constitution for patent law is to promote the progress of science and useful arts.  Where are the proclamations of obviousness from the technically ignorant going to lead?  There comes a point where they will be poisoning the well. 

October 14, 2014

A Direct Approach to Myriad - Or Is It that Simple?

The article provides a simpler analysis to the same outcome as the SCOTUS, but it seems to me a hindsight construction, with contrived premises.   

For example, a "composition" may a product of two or more substances.  But the article starts with the premise that the product is the substance.  The article says "an isolated naturally-occurring DNA segment does not fall within the above definition because it is a single substance and not a mixture of substances."   The article cites no case law suggesting a mixture of substances integrated in a reaction to a unitary product can not be a composition.   In fact, the article finds the unitary product of a "synthetically created" nucleic acid to be a composition of substances.    So, it looks like the simpler path to ineligibility was fabricated by misinterpreting composition and by biasing a composition depending on the rout to production.  In fact, common usage of the term "composition" does not depend on how the composition of two or more things got to their present state.  Further, a new composition can be a new combination of fewer substances.  Or, a composition can be new if it is changed in even a minor way, e.g., such as by cutting a strand and producing previously existing 3' and 5' ends.   So the isolated BRCA gene was a composition (e.g., of many nucleotide bases) that are different from a chromosome containing BRCA.   

Because the article deemed isolated genes not to be compositions, it had to further show in simple hindsight that isolated genes are also not items of manufacture.  Of course this can not be done, since isolated DNA is in fact the product of an isolation manufacturing process.  To get around this annoying fact, (and regrettably losing the desired simplicity of analysis) the argument is presented that the manufactured genes have no new utility.  However, it is notable that "new" and "useful" aspects of section 101 are treated separately, and alleged lack of utility does not somehow destroy newness of a composition or item.  This is immaterial though, because isolated genes do have utility, and it is different from the utility of the natural un-isolated genes.  For example, the isolated genes can be inserted directly into an expression construct, can be easily melted to separate strands, or hybridized to a specific target only associated with the isolated sequence. 

So, the simple route said to provide the same outcome seems faulty to me.  An isolated nucleic acid strand is a composition, composition claims are not subject to the method of their production, utility is not required for a composition to be new, and a composition with inherent advantages solving real problems does have utility.   

Different perspectives on the facts can lead to opposite conclusions.  I am not saying the Myriad claims were valid, only that the compositions should have passed section 101 for review under sections 102, 103, and 112. 

October 13, 2014

PCR to Triage Possible Ebola Patients

Ok, reverse transcription to PCR is not the kind of thing that provides results useful at the airport.  However, it could be useful in triage of patients instead of days of quarantine.    

Primerdesign has a $6000 quantitative PCR machine and some hot start reverse transcriptase kits to do a pretty quick detection of about any RNA virus (among other things).  http://www.primerdesign.co.uk/products/9633  

If the kits are not too expensive, it could be cost effective, even in developing countries, to know right away if a patient with fever  and other suggestive factors is indeed infected with Ebola, or not. 

China Says Genetically Modified Organisms (GMOs) May Not Be All Bad

Some find it fun to be political and show how smart you are by pointing out the negative side of every compromise.  But, eventually reality strikes.  Yes, there may be negative aspects of GMOs (e.g., selecting for glyphosphate resistance [not sure why those hating glyphosphate whine about this]).  (BTW glyphosphate is not natural, and it makes me nervous to use, but see the MSDS for yourself http://www.alligare.com/assets/pdf/Glyphosate_54_MSDS.pdf [but I digress - as usual]). 

Anyway, China knows that the most promising way to get more nutritious food (e.g., golden rice, and fast growing fish) to her population is through GMO foods.  How about drought resistant crops?  Water usage and fertilizers of the 60's green revolution have been pushed to the limits.  Too bad western media paints GMOs with such a broadly negative brush.  However, in the West too, the reality of GMO benefits will eventually win over hearts (and pocketbooks). 

Moderation in all things.  Life is in balance.  We can not throw out your options based on general prejudices unsupported by (sorry to say it) risk/benefit analysis. 

October 10, 2014

Blood Filter Away Our Ebola Problems?

Hey, wait a minute, weren't viruses first called "filterable agents" because they passed through filters? 

See a copy of a related patent at:  

https://www.google.com/patents/CA2630823A1?cl=en&dq=CA2630823&hl=en&sa=X&ei=UCA2VIjsGIKi8QHIhIDACA&ved=0CB8Q6AEwAA

 Apparently these filters present carbohydrates having an affinity for any number of viruses and other sources of pathology.  Still, knowing little, I suspect little benefit can be derived from capturing some of the virus in a patient's blood, given much of the virus is resident in endothelial and liver cells. 

Anyway, it may not hurt to look into this. 

October 9, 2014

No Need to Be Defensive - Patent Litigation is Down

One of the most powerful aspects of a patent (or even patent pending) is the uncertainty it causes in the market place.  Sometimes there is more value in having a presumed valid patent of record than taking the risky step of enforcing the claims (even at risk of providing a laches defense).   

There have been occasions where clients have requested a validity opinion after they received a cease and desist letter suggesting possible infringement of a patent.  When I developed strong evidence of invalidity, the client elected to continue practicing the claims.  The patentee never sued, knowing their patent was invalid.  They preferred to avoid a finding of invalidity so they could continue holding the patent over the heads of other players not having the funds to obtain an opinion or sophistication to call their bluff. 

The option of post grant review procedures has also probably reduced federal litigation, as it was intended.  I assume settlements are up, shifted more in favor of possible defendants.

October 8, 2014

"Good Wife" Not Totally Negative on GMOs

It is hard to prove a negative, especially when people's minds are made up already.  How to prove "Frankenfood" is not going to kill us, maybe, someday?  The biggest problem seems to be the human interest aspect of GMO sensationalism.  Framing GMO as a danger sells more news. 

The other problem with the image of GMOs is the aspect of worm killing and enabling more pesticide use.  The media does not seem interested in praising the GMOs that enhance nutrition or lower food costs.  The public does not even know about GMOs that can provide life saving recombinant drugs, with the possible exception of the recent ZMAP anti-ebola antibodies ( http://time.com/3457472/see-how-ebola-drugs-grow-in-tobacco-leaves/ ). 

Even with the cost/benefit ratio clearly in favor of GMOs, I do not see a trend toward an improved image.  I believe some people find it entertaining or fulfilling to be cynical. 

October 7, 2014

What One of Skill in Europe Knows - Will EPO Lighten Up on Added Matter Rejections?

One of the most frustrating things for me in patent practice in the last few years has been the illogical and unfair added subject matter rejections in Europe.  For example, if I outline a disclosure with a generic description of A+B+C elements in the introductory paragraph, then had paragraphs each describing alternate species elements a1, a2, a3; b1, b2, b3; c1, c2, c3, the EPO says I have not described an embodiment of a1+b2+c3.  That is, in Europe one of skill from reading the disclosure would not understand that one alternate of a first element can be practiced with an alternate of a second element. 

I have seen situations where an embodiment was described in a paragraph, and alternate elements for the embodiment in the next.  The EPO would insist one of skill would not know to practice any one of the alternates in combination with the immediately preceding embodiment.  It was like the paragraph of listed alternates did not exist at all.  The EPO insisted, combinations with alternates were "new matter" unless all elements of the combination were single paragraph, or in a single sentence.   It got so bad, I began the practice of drafting special paragraphs for Europe wherein I would systematically describe each permutation of the invention - a1+b1+b1, a1+b1+c2, a1+b1+c3, a1+b2+c1 ...  It was not pretty.

I know they have policy reasons to prevent inventors from falling back on alternate  embodiments to avoid novelty rejections.  But they threw our the baby with the bath water.   

The old added matter guidelines ( http://www.epo.org/law-practice/legal-texts/html/epc/2013/e/ar123.html ) stated:

“may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed”

There is hope.  The new guidelines  (Art. 123(2) EPC) state:

“When assessing the conformity of the amended claims to the requirements of Art. 123(2), the focus should be placed on what is really disclosed to the skilled person by the documents as filed as directed to a technical audience.   In particular, the examiner should avoid disproportional focusing on the structure of the claims as filed to the detriment of the subject-matter that the skilled person would directly and unambiguously derive from the application as a whole.”

Great! "what is really disclosed to the skilled person ...[in] the application as a whole."  Yay. 

Maybe now the European Union will have more respect for what even their less bright ones of skill in Europe would know from reading a disclosure with alternatives.  Where the theme is disclosed and variations are disclosed in the context of the theme, variants of the theme are understood by one of skill.  Some variations may not be as good, but even Mozart knew that. 

October 5, 2014

HIV Originated in the 1920's Kinchasa

Amazing that HIV did not venture substantially out of Africa for the first 50 years.  Further, the earlier O strain of HIV remained only in Cameroon. 

October 4, 2014

Don't Rush to Finalize Manufacturing Process Description

That was a good overview.  Fun to read because it relates to my prior experience developing purification processes.

Although there is a rush, I see no need to move to small scale batches with cGMP too early.  Best to focus more on the best process early.  There have been many times I have seen the process formalized too early.  Once the process becomes part of licensing documents, it tends to be written in stone and improvements are hard to insert.  I can think of products that used ridiculously inefficient and expensive processes for 20 years of manufacturing, that could have been improved early.

That was good advice on preparing additional example compounds.  You want to find the overall (PK, Activity, stability) compound for yourself.  Importantly, in order to claim a genus of compound, most patent offices require that you reduce to practice (actually or constructively) a variety of species of the compound across the full range of the genus.   Some countries (e.g., China) tend to only allow claim protection to those particular compounds you actually synthesize and characterize. 

October 2, 2014

Another Attack on Patent Claim Scope - Festo Expanded?

Another couple of attacks have occurred on the doctrine of equivalence.  First, a summary judgment where there are still material facts requiring review.  Second, whereas Festo (SCOTUS 2002)  http://scholar.google.com/scholar_case?case=8250508786110786578&q=Festo+Corp.+v.+Shoketsu&hl=en&as_sdt=2006&as_vis=1 ) has disallowed equivalents for specific claim elements narrowed in prosecution, here the larger associated structure also lost equivalents.   

An amendment during prosecution, not associated with the an aspect critical to showing infringement, was raised to eliminate reasonable equivalents to a larger element.  Instead of revoking equivalents to the precise sub-elements subject to the narrowing amendment (as held in Festo), this Fed Circuit case revokes equivalents the entire structure they were a part of.  This really muddies the waters because the Court does not describe where the loss of equivalents ends.  Does it include any part in contact with the amended (poisoned) part?   

The patent holder had amended the aspect of "the seal has a first end comprised of a bellows-shaped part sealingly attached to said holder, and a second end comprising a self-sealing membrane portion interiorly formed at an end of said bellows part". 

The amendment concerned part of a seal, which was a part of a trensfer member, the Fed Court, I believe misinterpreting Festo, decided to disqualify equivalents to the entire transfer member.  The Court insisted that:

"Although the applicant eliminated the “after use” language, the applicant nonetheless added the requirement that the seal have a first and second end with distinct elements. This narrows the seal limitation, which in turn narrows the transfer member limitation." 

An infringement defendant employing an equivalent of a claim element wins a summary judgment because an unrelated part of the element was narrowed in amendment during prosecution.  This is like losing equivalents to an entire car because you amended to narrow fuel system to carburetor, then having an infringer released because they used a mechanical fuel pump instead of an electrical fuel pump (the court not allowing equivalents to an electric fuel pump just because the patentee had amended the claims to require a carburetor).  [I use car analogies a lot - http://www.biopatent.com/cars.html ]

I remember when Festo first came out.  I thought it would be a disaster.   But, now this.  Where is the line of lost equivalents to be drawn now?  Change a "fastener" to a "bolt", do you lose the whole car (without even a hearing of facts)?  

October 1, 2014

Distinguishing "Identical" Twins with SNPs

A company called Eurofins apparently detects single nucleotide polymorphisms (SNPs) that arise soon after the twin cells split.  They must be fairly rare mutations.  I wonder if there are always enough of these mutations for the technique to work. Typically there are only about 10-6 mutations per cell division.  One estimate is that each individual carries, on the average, approximately 359 post-zygotic mutations that happened early in development.  There is often mosaicism, so the mutations are not present in every tissue sample.  I guess out of all those mutations, some show up on the Eurofins SNP library.  Or, do they just brute force it and do some systematic gene sequencing? 

Eurofins says rare mutations will occur early after or before the ovum has split into two, and that such mutations will be carried on into body and sperm cells, and these are what they detect.  http://www.eurofins.com/en/forensic-services/forensic-dna.aspx

Wall Wall Street Journal report on a similar topic.  http://online.wsj.com/article/PR-CO-20131210-900237.html

 

September 2014 Entries:

September 30, 2014

Inventions Lost in the Translation - Inventor Drafted Applications

Why should professionals draft patent specifications?  Because the intellectual property is the claims, AND you can only claim subject matter supported by the specification. 

I actually draft the claims first, then determine what is necessary to support the full scope of the claims.  I further fill the specification with a variety of fall back positions (as insurance against surprise prior art references).  The specification is the tool box have to depend on to work around the inevitable rejections in the first Office Action. 

You need to describe a range of species to support a generic range for each claim element.  If you are going into Europe, you must describe a range of specific preferred embodiments, not just ranges of each element (for some reason, one of skill in EP can not derive the combination of A and D from A or B with C or D).   

Often when Examiners can not find combinations of prior art references that reasonably render your claims obvious, they construe a critical term beyond reason in order to make it mimic this aspect in their best reference.   If your specification has unambiguous definitions of all key terms, you can prove a different interpretation is unjustified.  If the definition includes bracketed parameter ranges for the term, you can use alternate parameters to adjust the term outside the range of cited art.   

I find specifications by laymen often include admissions (e.g., what is not new) that work against them. Another common problem is describing devices according to what they accomplish rather than how structures interact to provide a function.   

I will not even discuss claims beyond the fact I have never seen layman claims that were not ambiguous or hopelessly narrow. 

There is the expression - you can pay me now, or you can pay me later.  Actually, it is not true in this case.  If your specification is unprofessional, is it already too late to obtain claims of reasonable scope, at any price.   

September 29, 2014

Who is More Biased About Patents - Federal Circuit, SCOTUS, or Media?

In 1982 the Fed Circuit was assigned the unusual and complex task of reviewing cases in the field of patent law.  The policy for assigning the Fed Circuit to patents was to have a single expert for these unusual cases. 

I disagree with the basic premise in the article that the Fed Circuit is somehow "captured" by the patent bar and biased toward it (e.g., supporting biopatents).  The comment is conclusory, with no supporting facts.  The Fed Circuit always hears both sides and there is no evidence that they have made buddies with one side.  The comment in the article shows the bias of the journalist writing the article.   

The biggest problem with the Fed Circuit/Supreme Court (SCOTUS) axis is that the SCOTUS are patent law inexperienced.  Even the article acknowledges that SCOTUS has had long periods of inexperience ignoring patent law, since the Fed Circuit was tasked with patent rulings.  SCOTUS can not even read claims (nor can most inventors, but that is another story).   

Let's review some facts.  The claims in the Mayo v. Prometheus case (method of adjusting dosage of a therapeutic) were poorly crafted.  For example, they could have linked administering and determining to active dosage adjustment instead of the scope broadening "wherein" clause outlining the correlation of metabolites to effective dosage in a disembodied fashion.  The only real steps in the Mayo method claims were "administering" a drug providing 6-thioguanine and "determining" the level of the metabolite in the patient.  These steps were old in the art and the claim should have been invalidated on section 102 anticipation grounds.   However, as a procedural matter, section 102 was not an issue presented to SCOTUS in Mayo.  SCOTUS had a gut feeling the claim was invalid, but section 101 was the only issue before the Court.  So, they just made up some disjointed  confusing nonsense and deemed the claim ineligible for patenting.  For example, this this muddle was presented in support of the invalidation:   

"the administering step simply refers to the relevant audience [huh? Where and how does the claim do this?], namely doctors who treat patients with certain diseases with thiopurine drugs. That audience is a pre-existing audience [what?]; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims [Oh, a section 102 anticipation argument].

The only sensible thing in the rejection is the anticipation argument, inappropriate in the context of the law suit at hand.  This was not a basis for a 101 rejection.    

OK, this is water long under the bridge, but is one example showing SCOTUS is the one misunderstanding patent claims and biased by public opinion.  SCOTUS is not all wrong on all the recent decisions, but my point is that the article concludes the Fed Circuit is biased, without providing any facts.  There is a good reason to have the Federal Circuit handle all patent controversies.  They are more expert.  It is an insult to suggest a bias toward patent attorneys (ironically by journalists biased against patents). 

September 28, 2014

Inter Partes Review (IPR) Remains Between the Parties

It is not a surprise to hear the majority of inter partes review (IRP) parties elect to settle.  As with other expensive tribunals, settlement is the norm.  Here, the additional fee of $14000 on PTAB acceptance (institution on determination a reasonable likelihood petitioner will prevail) is a significant cost.  As important is the possible loss of the invalidated claims, and the reserved value to intimidate other "infringers".  The value of the remaining uncertainty remains high after settlement (terms of which remain typically remain confidential). 

I believe a loss to the patent holder leaves open the possibility to appeal (e.g., Federal Court), but we know what that costs.  Best to settle, on reasonable terns to the petitioner, in many cases.  /span>

I believe the IPR is only available against patents filed on or after March 16, 2013.  With a 12-month time limit, cases with actual PTAB decisions should start to flow in faster.  Should be interesting to see the trends, once a representative population of decisions are available for analysis. 

Until then, it might be good not to be a beta tester for the system.  Avoid the patent death squad. 

SSeptember 25, 2014

India's Wiggle Room to Confuscate Drugs Affordably/a>

International law is all about wiggle room and give and take to adjust for the different priorities of the counties. 

It hurts to see intellectual property confiscated, but the insult is only psychological where the owner was not working the invention in the country and/or the product was so "unaffordable" in the market that there are actually no significant lost sales.   

India's wiggle room is not a nightmare unless they allow products to diffuse to the viable markets.  Someone has to compensate the good creators of beneficial compositions and devices for their years of work and risks taken for the benefit of all. 

September 23, 2014/strong>

Dangerous USPTO Advice

A USPTO update had crossed through my e-mail concerning the non-infringement toolkit, but never read it, until today.  I am not trying to be mean, but ...I was surprised by the bias and dangerous simplicity of the infringer's patent litigation "toolkit"  ( http://www.uspto.gov/patents/litigation/ ).

I have only had time to read the part on what to do when "... I Have Been Sued."

I assume a bureaucrat, not a registered Patent Attorney wrote the document.  I seriously believe that if a private Attorney (not protected by sovereign immunity) had published this treatise, they would be in danger of bar discipline and lawsuits for incompetence and malpractice.    

Even a highly competent attorney has a tough and unpredictable time navigating the paths laid out in the "...I've Been Sued" toolkit page the PTO has published.  http://www.uspto.gov/patents/litigation/Patent_Infringement_Lawsuit.jsp

First, the page never once suggests the person sued might consider whether they should STOP INFRINGING THE PATENT!  The default assumption is that an evil troll has sued an innocent victim, who is falsely accused of infringing.  However, step one, if you have accidentally (or intentionally) infringed a patent, you must stop immediately (even if the Plaintiff is a troll).  I can not believe stop infringing is not a listed "option" for when you are sued.  Such bad advice they are giving.

Next thing you know, the PTO is suggesting a layman should generate their own Validity Opinion regarding the raised patent in the law suit.  An opinion is among the most sophisticated tasks performed by a patent attorney with decades of education, training, and experience.  Now, the PTO is suggesting the biased, untrained, defendant should generate an opinion on validity of the subject patent.  Warning - Minefield. 

We have all had clients say their invention or practices are different from those in a prior art patent.  They will talk about the doohickey on their device that is not on the one described in the patent.  This, ignoring the fact that the doohickey is not an element of any of the claims.  Layman do not understand claims, and have no idea what is a claim construction table (required for duly diligent competent opinions).  The PTO "toolkit" mentions the existence of the file wrapper, and suggests it can provide "context".   The fact is, I have rarely found a file wrapper useful for "context" of claim term meaning.  More often, I have mined the file wrapper for critical fact patterns and juicy nuggets only understood in the context of controlling case law (subtle admissions on claim elements, loss of equivalents for narrowing amendments) - things laymen would not know.  Why is the PTO dangerously instilling false confidence in defendants to construe claims they are accused of infringing?   

Finally, the PTO suggests reading a glossary of concepts is all you need to see if the subject patent is valid or not.  Forget law school and the PTO reg exam.  What a fool I was!  With all this valuable information in hand, the next step is to simply file a Request for Reexamination, or such. 

It would all be funny if it were not so biased against certain citizens, and harmful to others.    

Next thing you know, the FAA is going to be publishing a toolkit so we can all fly a Boeing 747 without the need of expert advice.    

September 22, 2014

Where Are Those Inventions We Expected, but Never Arrived?

Where are those amazing things I expected to happen in my lifetime?  Yes there have been the moon shot, end of cold war (sort of), substantial clean up of industry (see the copper smelting town Anaconda, MT, where is was raised), and treatments for AIDS.  All these advances have been kind of mediocre and not well followed through on.  Except for maybe the internet. 

Where are the flying cars (one in the 60s, several now, but not common), cure for cancer (or even muscular dystrophy or nail fungus), trans-sonic jets, detection of intelligent life (on any planet), landing on Mars, energy so cheap you don't have to meter it ...?

Instead we have new big problems like "countries" that can not control mass murder by their uneducated people, and global warming. 

The long article by the admittedly anarchist author offers no solutions, but to tear down the present system.  Still, the article did wake me up to my personal disappointment over failed expectations in business, transportation, and medicine. 

How can we better motivate enterprise to achieve higher goals?

Spetember 18, 2014

Can Patent Expiration Reduce Availability of a Drug?

One of the scenarios I run across a lot when I talk to "inventors" of consumer products is that they have an idea that must be new because they have never before seen it on the market.  I will do a quick search and find that the idea was patented 100 years ago.  The inventor can not believe it.  Why isn't anyone making and selling this great product? 

Ironically, the product is not on the market because the idea has been dedicated to the public domain.  Anyone can practice it, so no one does.  There is the fear that if the product takes off, someone will jump into the market and destroy the profit. 

I wonder if this will ever happen in the pharmaceuticals market.  Has it already happened?  Seems like there was a time everyone abandoned the vaccines market.  The sales did not justify the cost of liability insurance.  Government stepped in.  Aside from the issue of being sued for not being perfect in saving lives, I wonder if the problem of old drug supply could be solved by the marketplace.  Lowest cost reliable honest producers.  Hmmm ... China .... try India?   AZ, GSK?

September 16, 2014

Opinions on Genetic Patent Eligibility in Australia v. U.S.

I suspect that Australian law also does not allow patenting of substances in their natural form.  And that is right.

However, a problem with the current U.S. case law is that, e.g., a new and non-obvious method of using information about the substance is now typically challenged as not patent eligible. 

September 15, 2014

Small Inventors - Accidental Targets?

I agree that laws directed to trolls (e.g., NPEs) can be a scatter gun hitting more than the intended target.  Some of the patent accumulators are indeed trolls.  But the laws can also injure small inventors, e.g., not diligently identified or negotiated with by the big practicing entities.      

On the other hand, I do not see the post grant review procedures as purely a disadvantage to small inventors.  If the patent is found valid in the review, the small inventor is in a much stronger position against the infringer.  Also, the infringer pays the surprisingly high PTO fee for the review.  In the mentioned Inter Partes Review, the patent holder is not subject to the recent section 101 (eligible subject matter) case law, but only anticipation and obviousness based on patents and publications.   

Over all, small inventors are unintended targets of recent regulations, court holdings, and price increases.  But it is not all bad news. 

September 12, 2014

Give Examiners a Break ... But Not Too Long a Break

I am sure there is anecdotal evidence of Examiners abusing work from home.

http://arstechnica.com/tech-policy/2014/08/patent-examiners-are-routinely-abusing-work-from-home-privileges/  However, I suppose the abuse would be just as bad if they were working in cubicles. 

One thing I noticed when I first started in patent prosecution was that Examiner's are generally over worked and stressed out (although they seem to get paid well enough).  However, ever since they started work form home, the Examiners seem less stressed and more friendly.  Also, being on the West Coast, I have been surprised to catch them in the evenings, their time. 

Those caught abusing lack of oversight should be punished accordingly (two strikes - Union be damned).  But they are adult professionals and generally to be trusted. 

I do not mind the occasional laughing baby or dog barking in the background. 

September 11, 2014

Personalized Medicine Patent Issues

The court cases seem to come up with the "inventive concept" standard for evaluation of the "significantly different" requirement.  I work a lot on European patent applications, where they have "inventive step", as the stand-in for obviousness analysis.  Inventive step is evaluated according to whether the "objective technical problem, would have been obvious to the skilled person".  ( http://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vii_5.htm ) "Inventive concept" reads "inventive step" to me and I can not help but think they are saying not obvious. 

The 101 subject matter evaluation seems to require obviousness analysis wherein, e.g., the newly discovered natural peptide is assumed to be obvious old art in itself, and must be combined with, e.g., an unexpected solution of the problem of detecting the peptide.  A western blot or ELISA will not do.  Even if the peptide had a previously unknown interaction with another peptide useful in a new analysis technique, this unknown (natural) interaction would still be considered obvious and lacking patentable inventive concept (though, I could make some good arguments). 

SSeems one of the few remaining strategies is to claim a highly specific use or analysis, so that not monopolizing the natural phenomenon would weigh heavily for patent eligibility.  Arguments could be made that the particular method has aspects making it not "obvious to try". 

September 10, 2014

Google to Make Us All Old

Interesting overview.  I had almost forgotten this Calico initiative. Will it be a success?  Of course.  But the goal was not lofty - “focus on health and well-being, in particular the challenge of ageing and associated diseases."  All they have to do is provide focus to a diverse group of scientists. 

Ironically, the article confirms that the project is already going in the opposite direction.   There is not a focus, but a plan to conglomerate diverse technologies and resources (like the "fully integrated" biopharma failures of the past).  It is true that no one discipline can solve the problems of ageing.  More than money and desire, I think the key variable is - Timing.  Are all these fields of computation, biology, (medical ethics) and pharmacology mature enough to fuse into a grand theory?  I doubt it.   

But it is fun to have a caprice when you have money to throw around.  Now, I know what all those patent attorneys Google hired last year are doing.    They are waiting around the virtual water cooler wondering how they will convince a patent Examiner that a grand theory is eligible subject matter for patent protection. 

September 9, 2014

 No Open Floodgates of Loser Pays - Yet

The holdings in Octane Fitness v. Icon Health & Fitness, 12-1184, and Highmark v. Allcare Health Management Systems, 12-1163, are not opening the floodgates of fees for winners of Federal Court cases.  Loser pays in the dominant system in most of the rest of the world.  http://www.bloomberg.com/news/2014-04-29/supreme-court-eases-rules-for-winners-to-collect-patent-fees.html

In HOMELAND HOUSEWARES v. SORENSON RESEARCH, the defendant was found in a summary judgement to infringe Prevention of void-based-irregularity formation in thin-wall, injection-molded plastic product  (https://www.google.com/patents/US6599460?dq=6,599,460&hl=en&sa=X&ei=XhAPVN_tK8aH8gHv24GgBg&ved=0CB8Q6AEwAA).  Defendant filed a appeal, including petition for legal fees, based on facts immaterial to the holding.  Fees were not awarded on a technicality, and on the opinion Appellant's Appeal was not adequately frivolous.   

A simple Appeal had cost one party a quarter million dollars.  Too bad we can have no expectation that winning parties will avoid such costs any time soon. 

September 8, 2014

Best New Antibiotics May Be Protecting the Old Antibiotics 

The search for new antibiotics has been dismally slow.  Pharmaceutical companies may be having more success rehabilitating old antibiotics.  Merck is studying the intravenous β-lactam antibiotic Imipenem in combination with Cilastatin and its Relebactam.  The FDA has fast tracked their application. 

Cilastatin inhibits the human enzyme dehydropeptidase, that can destroy lactamases in the kidney.  This helps the pharmacokinetics of the Imipenem.

Relebactam is not actually an "antibiotic" but inhibits bacterial lactamases from destroying lactam antibiotics.  So, Relebactam helps retain lactam antibiotic activity as it attacks bacterial cell walls. 

Next thing we know, we will all be using the first beta-lactamase antibiotic again - penicillin!  And so the world turns. 

September 4, 2014

 Disney in a Tussle Over Ears of a Dead Mouse

The Disney trademark shown in the article is number 73717780 ( http://tsdr.uspto.gov/#caseNumber=7371778&caseType=SERIAL_NO&searchType=statusSearch  in international class 025 clothing with a description of hats. 

You judge if there would be a likelihood of confusion.  Not sure why Disney did not raise their trademarks in the entertainment class 41, except the designs are less similar.  For example, see:  http://tsdr.uspto.gov/#caseNumber=85705877&caseType=SERIAL_NO&searchType=statusSearch

IIt seems there might be a small amount of confusion, and I believe the deadmou5 mark may have been intended to get some publicity from Disney.  Still, (unusual for me), I do not have a strong opinion either way, absent more facts than I have.  I just know, I would not want a tussle with Disney over one of their marks. 

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August Entries:

August 31, 2014

Are Electrolytes the "Cure" for Ebola?

Based on the comments of Mr, Ribner, the cure for ebola is usually standard supportive care.  The reason fatalities are so high in Africa is that patients often start out in poor health, are not routinely evaluated by standard simple lab tests (electrolytes, CBC, albumin), and do not have standard infusions available.   

This reminds me of the story about cholera.  Vibrio cholera mostly kills by action of cholera toxin that allows chloride channels to release chloride ions uncontrollably, followed by associated cations and water into the gut.  The result is perfuse rice water stools, removing water and electrolytes from the patient.  Some years back, researchers found that even without antibiotics, the mortality rate for cholera was reduced many fold by simply providing the patient with a source of rehydration, electrolytes, and glucose; even while the diarrhea continued.  See :  http://rehydrate.org/ors/rice-based-ors.htm

With ebloa, things are a lot more complicated.  Still, there is the similarity that survival may mostly require maintenance of proper blood chemistry.  Yet, a vaccine would be nice.   What do you think?

August 29, 2014

 Is Your HCV Treatment Quality-Adjusted Life Year Cost Effective?

Does Soldavi provide a cost effective alternative to other treatments at current prices?  Apparently, it costs four times more for Soldavi than previous treatments, while providing 1.6 quality-adjusted life years over standard care without drugs, and actually less benefit to the average patient than the IFN/ribavirin guided with genetic marker customized medicine.  Near as I can tell, Soldavi provides 1.6 years for $100k, while IFN/ribavirin in identified patients provides 2.8 years for the same price as treatment without drugs.   

12 weeks of Sovaldi in combination with ribavirin  (SOF/SMV) costs approximately $150,000, with sustained virologic response (SVR) rates ranging from 89% to 100%.  SOF/SMV yielded quality-adjusted life years (QALYs) of 14.69 QALYs.  

No drug treatment (symptom care only) strategy was associated with a cost of $38,747 and 13.10 QALYs.  The strategy using viral genotyping first and then adjusting the duration of combination therapy based on genotype was associated with a cost of $37,263 for 15.89 QALYs. http://onlinelibrary.wiley.com/doi/10.1002/hep.510300518/abstract

A QALY is is additional years of life, reduced by any suboptimal life quality.  See,

QALYhttp://www.medicine.ox.ac.uk/bandolier/booth/glossary/QALY.html . 

So, it seems the Soldavi treatment regimen provided benefits of 1 QALY for about $68k.  Years ago it was said that if you could not get a QALY for $50k the money was better spend elsewhere.  But is Soldavi a better deal than alternatives?  The Soldavi regime has the additional benefit of being more effective at clearing the virus from patients, making them less infections.  What is the value of the reduced transmission to other patients (or the eradication of HCV from the planet)?

This informal analysis compares separate studies, introducing many errors.  However, for those patients with gene analysis showing higher expected efficacy for IFN/ribavirin, this have the best cost/benefit ratio.  What do you think?

August 25, 2014

siRNAs May Offer Ebola Protection

It is interesting how far we have gotten with siRNA and liposome technologies.  The combination should apparently work to stifle Marburg viruses infecting or residing along the bloodstream.  siRNAs against the virus polymerase are encapsulated and injected into the patient days after infection with a lethal dose.  It is not a cure, but inhibits the virus to such an extent that the lethality is reduced substantially.   

Similar work was successful in primates infected with Ebola in 2010.  http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60357-1/fulltext   Small interfering RNAs (siRNAs) targeting the Zaire Ebola virus (ZEBOV) RNA polymerase L protein formulated in stable nucleic acid-lipid particles (SNALPs) succeeded in protecting macaques.   

The liposome technology is fascinating, with multicomponent formulations having different functions at different phases of manufacturing, adsorption, and cytoplasmic release.  The incorporation of fusogenic lipids such as dioleoylphosphatidylethanolamine (DOPE) improved the efficiency of endosomal release by encouraging fusion events between the liposomal and endosomal bi-layers solving the problem of endosome release.   http://tekmira.com/docs/Protiva_Heyes_et_al_2005.pdf

Here is a patent for liposomes by Tekmira Pharmaceuticals who made the medicine in the article.  https://www.google.com/patents/US20110256175?dq=20110256175&hl=en&sa=X&ei=34H4U5L1HJbJsQSg0IA4&ved=0CB8Q6AEwAA

TToo bad such technology probably would not work in AIDS, as these technologies do not seem to cure, and HIV hides in certain reservoirs not necessarily accessible by a simple injection.   

August 11, 2014

Trolls Will Not Be Jousting at Windmills

Patent Applications.  It is ridiculous to think someone is going to come out of the blue with five wind turbine patent applications that will ISSUE with unavoidable valid broad claims.  If they did, that would be great!  What a contribution to wind power and reduction of carbon foot print. 

It is not going to happen.   

These are APPLICATIONS (can you tell this has got me excited?).  They may start with grandiose original claims, but will be whittled down to focused claims (particularly with the pressure on Examiners generated by this publicity) easily engineered around, if they issue at all.

Further, there are no damages before issuance of a patent unless the infringers receive actual notice AND the claims issue essentially as originally filed.  I believe there is also no possibility of triple damages, e.g., for intentional infringement before the patent issues.  

"Infringers" will have time to make adjustments before issuance of any claims.  Then there are post grant procedures to challenge the issued patent claims:

Post grant review (PGR within 9 months of issuing - http://www.law.cornell.edu/uscode/text/35/321 )

Inter partes review (IPR - after 9 months http://www.uspto.gov/web/offices/pac/mpep/s2609.html ), and

Ex parte reexamination (any time after issuance - http://www.uspto.gov/web/offices/pac/mpep/s2209.html). 

Expect that the issued claims will have to meet tests of fire challenging their validity at the US Patent Office. 

If valid claims ultimately issue, infringers should pay reasonable royalties to practice, if they desire.  Alternately, the claims will NOT be as broad as the author is suggesting and likely can be engineered around.  The wind world is not ending. 

AIDS a Cure for MS, or AIDS Cure a Cure for MS?

Doctors reviewed large populations of AIDS and MS patients to discover that they had treated only one HIV/AIDS patient for MS.  Typical MS prevalence is very low but the two populations were large enough to notice a disparity.  See full article at - http://jnnp.bmj.com/content/early/2014/07/16/jnnp-2014-307932.full.  Then, they noticed AIDS patients with MS had symptoms reversed when treated for AIDS.  Hmmm.  Wouldn't be the first time MS had been inhibited by an antiviral - IFN-beta (Betaseron). 

Doctors hold open the possibility the infection may be inhibiting MS.  For example, the AIDS immunosuppression may be inhibiting autoimmunity.  The hypothesis does not seem to fit for me though, because the MS was further suppressed once the patient started taking the anti-AIDS drugs.  

There probably was no bias in that the control group was not limited to a population at high risk of HIV infection. 

I praise the UK system for having reviewable records.  I doubt we could do the same in the US. 

August 9, 2014

"The Invention Includes" Is Admitting Tooo Much

Pfeeew, that was a close one.  I thought written description might be going the way of the European added subject matter rejections where they require express unitary descriptions of all claim limitations in the specification.  However, the day was saved by having the subject matter in the original claims (said to be part of the original specification?) and some respect for what one of skill would have known from reading the totality of the application. 

See the Court case at: 

https://www.google.com/patents/US6910601?dq=6,910,601&hl=en&sa=X&ei=-sbmU5CyNoPE8QGX_4HYDg&ved=0CB4Q6AEwAA

What bugged me is that even one Not skilled in the art would know the sensors were not necessary to the function of the invention (or novelty/non-obviousness), yet the lower Court invalidated the claims based on the position that no reasonable jury could have found that the inventors were in possession of the concept of a device not requiring sensors.  This was based solely on the statement in the specification that "the invention includes" sensors.  Sheesh.  The Court thought the inventors were unable to run the machine without sensors just because the application included sensors as part of THE "invention". 

Lesson - have a broad array of claims in your original (provisional) application. 

Lesson - never describe the limits of "the invention" in your specification.  For example, "embodiments can include ..." may be better.

August 5, 2014

Strategies Combining New FDA Companion Diagnostic Guidelines with USPTO Patent Eligibility Guidelines

The Food and Drug Administration (FDA) has just released Guidelines for In Vitro Companion Diagnostic Devices (IVDs).  An IVD companion diagnostic device is an in vitro diagnostic device and method that provides information essential for the safe and effective use of a corresponding therapeutic product.  The FDA intends to require separate marketing applications for a therapeutic product and the IVD intended for use with that therapeutic product. 

See FDA Guidelines at:  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf

The United States Patent and Trademark Office (USPTO) has previously issued Guidelines for Determining Eligible Subject Matter for Patent Protection.  Ineligible subject matter includes, e.g., natural products, such as natural peptides or nucleic acids and their sequences (Myriad decision), correlations between drug metabolites and effective dosing regimens (Mayo decision), or expert systems that suggest treatments (Smartgene decision).  See:

Myriad - http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf

Mayo - http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf

Smartgene - http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1186.Opinion.1-22-2014.1.PDF

Well, this is quite a mine field of FDA and USPTO prosecution to go through, e.g., if you have a biomarker associated with a disease and you want some protection in the market place. 

To provide patent eligibility at the USPTO, claim your biomarker in compositions and methods using a combination of aspects that direct the Examiner away from an ineligible subject matter rejection: 

1) Claim the marker in an unnatural form, e.g., as a cDNA, linker modified, reporter modified, bound to a ligand/receptor.

2) Focus on the best mode, or your market plan.  Do not try to claim the generic concept.

3) Claim the natural phenomenon (biomarker/correlation) in combination with a machine and/or transforming method.  This works best if the machine or transformation provide a solution to a problem addressed by the claim, and are not just an extra-solution activity. 

4) Preferably, the elements or steps added to the natural phenomenon are the least obvious way to detect or measure the phenomenon. 

Once you get past the patent eligibility (35 § 101) question you will still have to defend against obviousness (35 § 103) rejections at the USPTO. 

Once you have a patent from the USPTO for compositions and methods for determining if a patient has your biomarker, you may still have to deal with the FDA.  If the method (e.g., assay) is essential for the safe and effective use of a therapeutic product (or to be used in a decision whether or not to use the therapeutic), the FDA will require submission of an application validating the method and associated device.  You will be required to, e.g., document the correlation with a patient population, specificity, accuracy, sensitivity, robustness, linearity, range, ruggedness ...  This can be a difficult license to obtain but is also a barrier to entry for competitors. 

The good news is that even if you have to narrow your claims to get a patent, and competitors can engineer around your claim scope, you can still obtain large competitive advantages.  If competitors engineer around your patent, they are likely going to settle on a second best method or device.  Typically, the competitor engineered alternative will be obvious in light of your application, so they would not be able to obtain a patent.  If their engineered alternative is a patentable improvement on your claimed invention, they would have to license your generic concept in order to practice their species improvement.  No matter how you look at it, you would be in a better position than the competitor.   

Even if a competitor manages to get past the patent barriers to your market, they may still have a huge obstacle in licensing at the FDA.  If you have a patent on a new therapeutic  composition, you may qualify for a period of exclusivity, e.g., beyond the patent term to compensate for the inability to use the invention during the FDA licensing process (Hatch-Waxman exclusivity period).  Sorry to say, there is no FDA exclusivity periods for medical devices. 

Finally, depending on the risk involved to patients, a competitor with an identical device or method may be required to file an FDA application establishing their device is "substantially equivalent" to your device.  If their device or method is different, they may be required to file a new medical device license application from scratch, with associated cost and delay. 

So, depending on the particular facts of your case, strategies are available to gain market place advantages for your biomarker, therapeutic, and/or medical device.  To determine a strategy best for your situation, contact a professional with knowledge of FDA licensing and patent prosecution at the USPTO (e.g., contact me at Baker@BioPatent.com)

August 3, 2014

TEVA Accused of Evergreening - Good for Them

It seems TEVA's initial patent for Copaxone (glatiramer acetate) for treatment of multiple sclerosos (MS) is about to expire.  See  glatiramer acetate for treatment of CNS diseases - https://www.google.com/patents/WO2001093828A1?dq=intitle:Glatiramer+intitle:acetate&ei=HvjcU8ehGMPC8QGb4IDoCg&cl=en

TEVA has tried everything to retain control of Copaxone from generics, including going to the Supreme Court (http://sblog.s3.amazonaws.com/wp-content/uploads/2014/04/CA-Alend-draft-petition-FINAL_for-Wilson-Epes.pdf ).

Worst of all, they have even tried to improve the drug, dosing, and processes, to remain competitive in the market.  Funny, drug companies can get a bad reputation for improving their drugs.  Evergreening.   

I was reading an article on the TEVA roll out of a new formulation and dosing regimen.  One patient noted:

"As a consumer, I dislike this kind of thing more than I despise needles. While I don't know what Teva's development schedule for this product has been, but as a patient, I have questions. I wonder if it could have introduced this new product, with its advantageous dosing, years ago. However, it's strategically better to extend the new patent on this particular variation as far into the future as possible and not overlap with the classic seven-shots-a-week version, and also move patients onto the new and improved version as soon as possible."

I do not know TEVA's motivation for their product roll out timing of the improved product.  However, TEVA did expedite prosecution of the patent (starting with a provisional application in 2009 and issuing in 2010), and had the product available soon thereafter.  See: https://www.google.com/patents/US7855176?dq=WO2011008274&ei=9fvcU5KkJual8gHJuoGoBw&cl=en   However, they have now converted 60% of their MS patient base over to the new (and patented to 2030) formulation.  Is this evil evergreening? 

Is it a bad thing when a company invents a drug that reduces relapses of a disease and then (later) makes improvements?  Is it an evil plan when the inventors continue research in their area of expertise and develop new and non-obvious improvements? 

Soon, several other drug companies can begin marketing copies of the original Copaxone.  (The drug being a randomized series of four amino acids, it is questionable that the copies will actually be identical to the original.)  That is their right.  And patients can continue taking the old version at a lower price.  In fact, TEVA has developed more efficient methods of manufacture (WO2013065071A1 - https://www.google.com/patents/WO2013065071A1?cl=en&dq=WO2013065071A1&hl=en&sa=X&ei=xvncU-3UPIr38AGtiYDICA&ved=0CB4Q6AEwAA ), so they could even provide the original version at a lower price than the other generic sellers, or help reduce the cost of their improved formulation. 

Seems like all good news to me.  Too bad the general public does not seem to know that when a patent expires it goes to the public domain and anyone can practice it.  One can not extend a patent another 20 years by putting the drug in a new excipient (e.g., buffer).  Typically, such a new claim would be old or obvious and the patent invalid.  If the patent is valid, we should thank the inventor for the improvement.  Buy the improved product, if it is worth the extra cost over the old version. 

Thank You Evergreeners!

By the way, I established the shelf life of Betaseron and occasionally helped technicians in manufacturing.  It is still perplexing to me that an antiviral has a mode of action in an autoimmune disease, like MS.  That crazy network of cytokine interactions.   

July Entries:

July 25, 2014

Tylonol Does Not Cure Back Pain - Who Knew?

Good study population size, so that makes the study pretty convincing.  Bad end point though for an analgesic study - median time to recovery.  Seems strange an analgesic being evaluated as a cure.  Also, the study did not include a group that did not receive any treatment, i.e., no placebo patients.  The data did not include short term relief from the pills, only the end point criteria of pain-free for seven continuous days. 

The study was published in The Lancet July 23, 2014

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60805-9/fulltext

I used to have lower back pain, mostly from an imbalance resulting from a construction injury.  The pain went away for good once I started exercising 3 times a week.  Biking seemed to help the most. 

July 24, 2014

India Not Too Unfair - Evergreening of Patents is a  Myth 

I have never had a bad time patenting in India, but for some minor administrative glitches, to be expected.  Nothing unfair.   

It is annoying when foreign countries steal inventor's intellectual property in the name of saving those that can not afford the product.  If it is so important, why doesn't the foreign government pay for it?  Easier to steal it, I guess.  However, India has only exercised the compulsory "licensing" clause once, that I know of. 

In my opinion, there is generally no such thing as "evergreening" (repatenting) of a drug.  If a drug company has a pioneering product nearing the end of the patent term, anyone can practice the product after it expires - this, even if the company manages to receive a new patent, e.g., with the drug in a new buffer or time release form.  That does not evergreen the pioneering patent.  Further, the new buffer formulation for the drug is generally obvious and should not ever be granted.  There should be no such thing as evergreening in a standard patent system that is functioning properly. 

July 21, 2014

Jets without Pilot Windows

OK.  Everyone liked the Airbus bicycle seats so much, I decided to also show their other great new idea: jets with no window for the pilot.  See patent application at:

https://www.google.com/patents/US20140180508?dq=20140180508&hl=en&sa=X&ei=SJu1U8fWMtOTqgbcgYKwBQ&ved=0CBwQ6AEwAA 

I am a private pilot and ever since GPS moving maps commonly entered cockpits (about the last 5 years) pilots are looking out the window less and less.  The GPS flat screens even have a lady who yells at you and tells you when another airplane gets within 5 miles of you.  A screen pops up and shows you where the other plane is.

Private pilots are actually trained to fly the plane without looking out the window (even before moving maps using "steam gauges": attitude indicator, altitude gauge, turn coordinator, heading indicator; running on gyroscopes, and such) - see, old Cessna instrument panel: http://www.biopatent.com/panel.html.  This training is in case the pilot ever flies into a cloud (what are the odds?).  So, what I am saying is, even private pilots in small planes are looking out the window less and less. 

Apparently the pilots of airliners are also not looking out of the front window, e.g., see Ariana 214 crash in San Francisco (side story - I was on a US Air flight just hours after that crash and our jet almost went off the shorter alternate runway at SFO while the firefighters were goofing on the main runway).  If you look out of the windscreen and see that the runway threshold seems to be going higher and higher, you are not going to make it to the runway - is that too complicated?  All you have to do is look.  But the pilots were letting the computer fly. 

Actually, even my small rental Cessna has a moving map and autopilot that could allow you it to go on an entire flight without a pilot, right down to the approach.  However, it requires a pilot to flare and land softly on the runway. 

So, windows are on their way out ... and so are the pilots.

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Avoid Admissions of Claim Scope in Your Application

"A tension in drafting a patent application to improve the chances of actually receiving a patent and drafting the application to ensure that the resulting patent claims are not construed narrowly based on the specification embodiments."   

See case at:

http://caselaw.findlaw.com/us-federal-circuit/1671883.html

I do not see the tension, or even a problem.  I have never experienced a time when I convinced an Examiner to allow claims because a feature in the claims or in the specification was "essential".   One can not back track from an Admission.  I just reviewed an inventor's disclosure (his version of a provisional application) and removed all references to "necessary", and "required" aspects in my filed version. 

How about trying this - put the "essential" aspect in a dependent claim?  The independent claim can still have broad scope.  If unknown prior are arises without the essential feature, put it in the independent claim from the dependent claim (shouldn't even be a written description rejection, even in Europe).  On top of it, the case may be strengthened by an expert declaration confirming the essential status, if it ever came to it, and it almost never would as a practical matter. 

Not that I am a litigator.  Maybe I am missing something. 

July 14, 2014

Spicy Eye for Alzheimer's Dx

Curcumin is a bit of a wonder molecule (antibacterial, antioxidant, cancer reducing, blood clotting, makes messy stains in my kitchen).  It is even cited (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2781139/ ) as a Treatment (not just diagnostics) for Alzheimer's. 

I did some searching, and found the patent for imaging with curcumin (http://worldwide.espacenet.com/publicationDetails/originalDocument?CC=WO&NR=2011119602A2&KC=A2&FT=D&ND=3&date=20110929&DB=worldwide.espacenet.com&locale=en_EP ), and another article on more bioavailable curcumin ( http://www.ccsenet.org/journal/index.php/jfr/article/view/36189/20874 ).

The whole turmeric and curcumin thing raised a big ruckus years ago when patent applicants tried to claim methods of using them to treat or prevent any number of illnesses.  India, for one, complained the ancient practice was being stolen.  Of course, patenting rules foreclose patenting of something not new, but that seemed to go over everyone's heads. 

Still, this all leaves open the question of how the apparently oral curcumin actually crosses the blood/brain barrier.   

Any ideas?

July 11, 2014

Put Up Your Dukes

What is up with Duke University? They have a registered trademark design that includes the word DUKE in the international class 025 for clothing. http://tmsearch.uspto.gov/bin/showfield?f=doc&state=4807:qimqxg.5.33

There are at least 60 live trademarks in the alcohol class (033) that include Duke of terms that sound like Duke. For example, DUKES FAMILY VINEYARDS, THE DUKE MUNICH DRY GIN. and THE DUKE (whiskey http://tmsearch.uspto.gov/bin/showfield?f=doc&state=4807:qimqxg.4.2).

Why is it Duke U. the one raising this ruckus? There would be little likelihood of confusion between Duke bourbon and Duke U. t-shirts. Duke U. is probably trying to get leverage for a settlement with Duke bourbon promising to modify the trademark, and stay away from clothing.

One thing is for sure, Duke Bourbon got more money's worth of advertising out of this than their litigation costs, so far.

July 7, 201

Intent to Use Trademark Application Can Not Be Used to Hold a Mark While You Look for Inventors

There has to be a process in place to screen out trademark filers with no real current intent to actually use the mark, e.g., on goods.  A hope is not good enough.  The goods should come first, not the mark.  "What will I name my goods?"  Not, "What goods should I put this cool mark on?" 

It only costs $325 to file a mark.  After the mark is found appropriate and not conflicting with a confusingly similar mark, you have 6 months to file a Statement of Use, showing evidence that you have used the mark in association with sale of the goods.  Various 6-month extensions ($150 fee - http://www.uspto.gov/web/offices/ac/qs/ope/fee010114.htm#tm) are available to continue swearing you have a bona-fide intention to use the mark. 

You can see that a person without a product but only the trademark application can shop around for years trying to find a product or partner.  By paying minimal fees the applicant can hold the cool mark trying to keep others from using it.     

This abuse may be minimized a little by a recent case Lincoln National v. Anderson  ( http://e-foia.uspto.gov/Foia/ReterivePdf;jsessionid=B58B29D60C54D908FF42EFAE0F6B5A8F.prod_cidmext_jboss1_jvm2?system=TTABIS&flNm=91192939-02-21-2014 ).  In Lincoln, the trademark applicant for "FUTURE" was shopping for a licensee, not a product, and lost his rights. 

Worse yet, such behaviors can come back to haunt you.  Even if you eventually get the big money licensee or partner and start actually selling goods with the mark, the mark could be taken away if the facts show you did not actually have the necessary intent AT THE TIME YOU FILED. 

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Why Does Big Pharma Have a Bad Reputation, After It Has Saved So Many Lives?

I don't think the bad image is due to lack of advertising.  Actually, to the contrary, I have heard a lot of criticism in the media of the money pharma spends on advertisments. 

Ironically, the big problem is that we help sick people.  But ... we have to charge them money Years ago, Genentech had a big summer party for the employees and actually hired the Rolling Stones.  What an uproar.  "Taking money from sick people and having a big party!"  Now Genentech's summer party is always a big charity event - Genentech "gives back".   If Pharma makes any profit, they can not spend it without being accused of spending blood money.

Although successful pharma makes a nominal profit, considering the risk, the accusation is always that the profits are excessive.  The most hurting example is when pharma charges $1000 of a dose that costs $75 to manufacture (not counting the expense of the research to discover and develop the drug, and THE EXPENSE OF THE NINE OTHER FAILED DRUGS THAT NEVER MADE IT TO MARKET).  No one wants to pay for research or failures (especially countries that have no productive research of their own) so they vilify pharma so they don't have to feel like they are stealing. 

Of course, politicians are the big heroes that show how humane they are by asking questions like "why are drugs cheaper in Canada?" 

What to do?  Let those who will listen know the NET PROFITS of the AVERAGE drug company (including small ones and ones that FAIL every day (sorry about the yelling)) are not out of line.  Ask those who complain about drug prices to see if they can do a better job, if developing druigs is such a gold mine. 

Something that might help ... elect politicians that have the real facts.  I am a member of a general aviation group (Aircraft Owners and Pilots Association) that has only 200,000 members but we manage to have significant influence in matters of importance to us.  How many voters are there in the pharmaceutical industry?

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Where are the Biotech Jobs, Really?

A recent article ( http://www.bostonglobe.com/business/2014/06/18/mass-leads-nation-life-sciences-jobs/MOuNJRZsdk3bNtcGnTvtVN/story.html ) states that the "undisputed leader" " Mass. leads nation in life sciences jobs", and I was quite surprised.  Had the combination of federal taxes, state taxes, anti-business climate, excessive regulations, and arrogant attitude, driven all the biotech jobs out of California?

My wife's previous biotech employer pulled out of Cal. and went to more friendly Germany. 

Looking into it, I see that California has three times as many biotech jobs as Mass, and Mass is actually number 3 (or 6?) in terms of total jobs, after at least Illinois (http://medcitynews.com/2012/06/these-7-states-really-know-biotech-and-probably-have-jobs/ ).   San Francisco Bay Area and greater Boston each have about 50,000 biotech jobs.  But Cal. also has San Diego. 

SSo ... Mass has the most biotech jobs PER CAPITA. 

I am not so sure Mass. is the "undisputed leader" in biotech.  Reminds me of the cold war (not that SF is at war with the Boss) when the Soviet Union had the "biggest" everything, but was that heaviest, longest, densest, tallest, most massive, most volume, or most expensive and least functional (airplanes that were only good for propaganda)?

July 3, 2014

10 Problems with 3D Printing

The universe is in balance, and there are pros and cons to everything.  It is good to think of these things in advance and avoid problems without having to experience them.

For example, the issues of toxic residues and microenvironments for bacteria on 3D printed dishes can be resolved with higher resolution printing and appropriate choice of printing media.  First generation printers will be energy hogs, but they will become more efficient with time; and there are trade offs, such as not requiring energy to transport the item to the end user. 

The article raises several legal issues.  Copyright and patent licensing issues are already being addressed for legitimate sales; and there will be pirates, as in the music and video industry. 

I believe the problem number 8 regarding printing of drugs is misstated.  Although drugs (e.g., pills) may be printed (replacing the pill press), the printer requires starting media already containing the drug.  See, e.g., https://www.google.com/patents/CN103393543A?cl=en&dq=3d+printing+of+drugs&hl=en&sa=X&ei=3HS1U8-oM9GWqAaU4ILQCg&ved=0CB4Q6AEwAA.  The 3D printer will not carry out reactions of pro-drug starting materials (which themselves are often difficult to obtain).

The printing of tissues and organs can be a great thing for many patients.  Of course there are the ethical issues (like the old proposal to transplant pig hearts into humans (not for those of the Jewish persuasion).  Hold the dog muscles in my new toe!  The good news is that innocuous printed scaffoldings can be populated with stem cells from the same patient to receive the organ, to avoid physical and emotional rejection of the body part. 

I will keep an eye out (not literally) and will immediately send a cease and desist letter if ANYONE tries to 3D print a copy of my beautiful nose. 

 I.  June Entries

June 30, 2014

Supreme Court is Confusing Obviousness with Ineligible Subject matter

You can not patent a natural phenomenon, or an abstract idea (such as the Pythagorean theorem).  However you can patent a method (see 35 § 101) .

The analysis in the article and in the Mayo holding is totally screwed up (a legal term of art).  The article says:

" If a particular software patent’s claims can be distilled to a general concept that was in existence long before someone thought to implement the concept in software, there is a good chance it is an unpatentable abstract idea. ... the only way to convert these otherwise unpatentable abstract ideas into a patentable invention is to show something else in the patent’s claims that make it a new invention. 

Excuse me, but this is 35 § 103 OBVIOUSNESS analysis and § 102 NOVELTY analysis!  The method in the claims deemed patent ineligible is not a natural phenomenon, or an abstract idea.  It the method section 101 eligible subject matter unpatentable for obvious under section 103.

A method of taking seeds from a cotton ball by carding it through brushes is not an abstract idea, it is the the basis of Eli Whitney's cotton gin.  What is left to patent if everything is an ineligible "abstract concept"?  IMHO, the SCOTUS should get out of the business of analyzing intellectual property in light of the constitution and laws until they get registered at the PTO.

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Aereo Trhough the Heart - Off Air Recording Service is "Public Performance"

There goes SCOTUS running on their gut feelings again in IP law, when the facts do not support the holding.  SCOTUS has a gut feeling Aereo is using technicalities to get around the law (and they are).  But this is no reason to get back at them by intentionally mischaracterizing the facts.

"Breyer said that Aereo's activities are substantially similar to that of cable companies."  However, Aereo is not broadcasting programmed material like a cable company.  Their procedures are more like a recording a show for later playback, like I do from an attic antenna at my house to a hard drive on my computer for later viewing.  What?  Are they going to throw me in jail now for recording and later viewing off the air waves?

"Aereo still transmits copyrighted programs to a large group of people [at different times watching different shows] who are unrelated and unknown to each other, and they constitute "the public,"  Bull ... oney!  Aereo relaease a program to a viewer who elected to store it for later viewing.  The viewers watch their show when they decide to present the show to themselves.  Aero never transmits a show to a large group of strangers. 

What a twist of the facts SCOTUS used to provide the outcome they felt was more "fair".  SCOTUS should remember their place is to apply facts to law, not to make up facts to fit the legal outcome they desire. 

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Inhalable Insulin Approved By FDA

Apparently, fumaryl diketopiperazine (FDKP) enhances passive transport across cell membranes, and eventually into the blood stream.  See http://professional.diabetes.org/Content/Posters/2004/p484-P.pdf

See patent at: http://www.google.com.ar/patents/US20040077528

BioPatent behind the story.

 

June 27, 2014

Agarose versus Polyacrylamide: Not All DNA Gels Are Created Equal

 

Do lab technicians still pour their own gels? I suspect they are all retail products now days. It should be a right of passage to make all new technicians pour a PAGE gel.

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Study on genetically modified corn, herbicide and tumors reignites controversy

Apparently, the negative control rat population was small and number of spontaneous tumors, though known to be high, was not evaluated. Positives were considered across a variety of different tumor types. 


I suggest the article should not have been reprinted, but the study should be redone with a more statistically valid population of test animals. 

As a side, has anyone suggested a mode of action for carcinogenesis of a variety of different tumors when EPSPS (glyphosphate resistance peptide) is EATEN and digested?

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New Bill Aims To End Bias Against Women In Clinical Trials

At risk of not being PC, I think the issue of political "fairness" does not belong in science. It makes sense to randomize a population of males and female animals (humans) for end game study. 

However, if you are doing a study of a small molecule activity on a cell, do you want to be required to do the study on a set of female cells (HeLa) and also on a set of male cells (SheLa?) 

Who is for politicians and journalists setting the rules for scientific research? Raise your hand.

June 24, 2014 - The Patent Trial and Appeal Board (PTAB) is Not the Patent Death Squad

Managing Director of the Quine IP Law Group

I found various sources stating that 76% of post issuance procedures at the PTAB end in a finding of patent invalidity. This does not have to happen to you.

There are a lot of caveats behind these numbers, though. I only looked into it for a few minutes, but it seems there are a lot of cases not considered in this figure (correct me if I am wrong). 

For starters, post issuance review is somewhat self selected for weak cases. That is, a patent is more likely to be challenged if it is clear it has a significant flaw. So, possibly a higher portion of unchallenged patents are valid. 

Next, keep in mind, not all patents found invalid were "junk". Patent professionals try to obtain the broadest valid patents they can for their clients under the prevailing law. However, the law keeps changing, and lately the pendulum is swinging away from patent protection. For example, there have been recent court decisions that expanded the range of subject matter considered ineligible for patent protection (correlations of metabolites to does efficacy; certain gene sequences). There are also recent cases making it easier to challenge the enabled scope of claims (invalidating "overbroad" claims). A patent practitioner can not be expected to predict the outcome of court cases over the course of a 20 year patent term (although they can try to include backup positions in the claim set).

Then there are settl