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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

Biotech and Intellectual Property

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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. 

My topics are probably annoyingly varied (auto mechanics, molecular biology, airplanes, patents).  Please scan through to topics you care about.  Please read hyperlinked stories, then my insightful comments!

The communications on these web pages are not intended to create an attorney-client relationship.  Do not act or rely on any information in on these web pages  without first seeking legal advice from competent counsel.  This material is intended for general information purposes only and does not constitute legal advice.    

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/p>

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 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.

May Entries:

May 31, 2016

It Did Not Take an Oracle to See Function Name Use by Google Was Fair Use

"Oracle argued that the list of Java function names and features constitutes a creative work ..."  Oh, yes.  Very ornamental and artistic.  I can see that it is not "functional" to use the address names of "functions". 

There was the case where it was not copyright infringement to steal an entire phone book listing, in the same order.  And the Lotus case where it was not infringement to utilize spread sheet functions in a functional order. 

What does a copyright protect? ... original works of authorship including literary, dramatic, musical, and artistic works, such as poetry, novels, movies, songs, computer software, Web sites, and architecture.  Here, it seems Google has employed function identifiers, that may have descriptive names, to make their Android software compatible with Java.  It seems doubtful anyone would consider any one of the function names to be a work of art, or even the listing of names in any particular order.  It seems even less of the "creative heart" of the functions would be taken where the function names are used scattered throughout original Android programming.  Doesn't look like copyright infringement to me.  But, I have not read the published cases.

In this second local Federal Court case, the issue at hand was "fair use".  So, I guess this presupposes that the material was copyrightable.  According to Google Legal Help - "Borrowing small bits of material from an original work is more likely to be considered fair use than borrowing large portions. However, even a small taking may weigh against fair use in some situations if it constitutes the 'heart' of the work."  So ... you (and the Federal Circuit) be the judge - is smattering function identifiers in whatever order in a functional computer program constitute a taking the "heart" of the Java function listing? 

I wonder how music sampling case law relates to this.  At least the music is actually art.

May 30, 2016

Magnetic Device Forms Beneficial Intestine Anastomosis Without Incisions, or Sutures

Remember the danger of kids or dogs swallowing two or more of the really strong neodymium magnets found in some toys?  They can track to different parts of your intestines capture each other through the intestine walls, form an adhesion, and maybe a necrotic breach. 

Well, it is not all that bad.  This invention actually creates a port between intestine segments, short cutting digestion and reducing sugar surges that cause long tern harm to diabetics.  I imagine there is some weight reduction involved too.  Interesting that there were no peritonitis episodes.

May 29, 2016

Food Production Problems Are Big Enough for Both Selection and Genetic Engineering

The article suggests that old school selective breeding is still far better at solving real problems than genetic engineering of crops.  It may be so, but I think not.   

Genetic engineering has it's place in solving simple one-gene problems, like fruit browning caused mostly by a particular enzyme.  It seems a lot of genetic engineered food products have failed for reasons other than failure of the engineering.  For example, government regulation, anti-GMO hysteria, and even failure to have a market (who knew people wanted traditional white rice and not "golden" rice, with extra vitamin A?

Selection of root morphology is admittedly not solving the combination of conflicting problems we are experiencing.  Lateral roots for phosphate, long roots for nitrogen and water.  I also suspect that many of the "selected" crops are hybrids, that do not breed true in the later generations, so they are less desirable in poor countries where lack of water and fertilizer are bigger issues. 

There would obviously be benefits in using both selection and genetic engineering to obtain the combinations of desirable features in the shortest amount of time.  How about engineering the selected plant with lateral roots requiring less phosphate to also have the engineered trait of an improved nitrogen alanine aminotransferase (AlaAT) to minimize nitrogen fertilizer requirements?

Geez ... what's better genetic engineering or selective breeding?  or both?

See the full Nature News article at:

http://www.nature.com/news/the-race-to-create-super-crops-1.19943

May 28, 2016

Spinal Implant Sterility May Soon Be Mandatory

Ok, I was surprised that sterile packaging was not already a requirement (in the U.S. ? - the article appears to be from UK) for certain implants.  I suppose this may have been because many medical devices are complex and comprise materials that do not hold up well to typical sterilization techniques (autoclaving, oxidizing chemicals). 

May 27, 2016

Removal of HIV Sequences in Mice and Men (T-Cells) 

An adeno associated virus (AAV) vector expressing the CRISPR/cas9 system was used to remove HIV sequences and stop replication in cultured human HIV patient T-cells.  An AAV vector was also used in vivo in a HIV-1 mouse model to remove "the viral genome in every single tissue throughout the body (the brain, kidney, liver, spleen, blood, etc)."

I find it fascinating that the AAV, administered intravenously, finds its way in to such a variety of tissues. 

Too bad AAV is typically a one use vector.  Use it for any particular indication, and immune response may ruin it for any other use (or even the first use may be ruined, if you have had AAV with your "cold". 

May 26, 2016

A Good Life - Side Effect: Less Cancer

The article says that about 40% of cancers could be prevented with healthy lifestyle.  This, compared to those in the study group that had a less healthy lifestyle. 

Then the author noted that the "less healthy" group were actually more healthy than average citizens (all subjects were health care professionals), therefore they say the data are an overestimate.  To me, it seems the number would be an under estimate, with the differences even greater if the less healthy group were even more unhealthy.  Maybe I missed something. 

Anyway, exercise, eat healthy (e.g., cook your own food), don't be too stressed (like you are in control of that).  The side effects are feeling better, spending less, enjoying better food, and being more happy.  Yeah?  But ... what are the side effect of that?

May 25, 2016

Exhaustive Compilation of GMO Studies Finds Them Safe to Eat. 

The only comments against the conclusion that GMOs are as safe for human health as non-GMO foods are "conspiracy" theories (NSA is in pocket of Agriculture giants). 

Of course, some GMOs can have undesired negative impacts.  These should be reviewed and mitigated.  But ... all progress has such impacts.  If you disagree, stop using modern transportation.  Wait, there were problems with horses.  Wait, even walking to your destination is a bad idea - do you know how many calories and negative externalities are associated with feeding yourself just one candy bar (even if it is not GMO)?

May 24, 2016

Sticky Car Not a Hit With Me

I have been hit by cars several times (only once my own fault).  There can be a first impact with the front of the car, some rotation and an impact with the hood, some sliding and an impact on the wind shield, a bounce, and a slide back down the hood.  

The energy is gradually dissipated.  I don't think it is a good idea to be stuck and have the energy all dissipated in the same place.  Then, there are the other problems like the shelf life of the sticky stuff in the sun, stability of the paint job, who is going to have your clothes dry cleaned,  and what to do with all the butterflies. 

May 23, 2016

Protein Snippets are Like Servers in the Internet.  Wow. 

As often happens, the title of the article is misleading to make things more grand.  Scientists have LONG known that there is modularity in protein sequence snippets going back to archaic organisms.  

And, this is not with regard only to loops, but beta sheets, alpha helices, and a variety of catalytic pockets of enzymes.

May 21, 2016

Columbia Threatens to Break Novartis Drug Patent for Lower Price. 

Another example of a government using threats to "break" patents to negotiate for a lower price.  Here, at least, there are generic alternates available on the international market so the Columbian government would not have to figure out a way to manufacture the drug themselves.

Columbia may be making a mistake, though.  They could end up saving a few million dollars on a cheaper priced generic, but generate a greater loss in good will with developed countries.  And, this for a drug having a patent in is set to expire 2018 in Columbia.

Geez, it is a little ironic that Columbia is complaining about the high price of imported drugs, in light of the price they charge for THEIR drug exports. 

May 20, 2016

Open Chromatin Regions are 1% of Sequences and 40% of Phenotype Control

It makes sense that the expression controlling regions of chromatin should be exposed to the nucleoplasm environment.  It is also interesting, and confirmed, that these relatively naked regions are common cross-over points for recombination.

I believe the research  article ( http://www.pnas.org/content/early/2016/05/13/1525244113.full ) says 3% of corn sequences are expressed genes and 1% is open chromatin regions that strongly influence expression of the genes.  The open chromatin regions (identified by their susceptibility to micrococcal nuclease (MNase) digestion) appear to control 40% of phenotype variance, while the genes themselves control 60%. 

Wow, what a demotion of "genes".  There may be some desirable phenotypes that we can only engineer with a better understanding of open chromatin regions. 

Then ... there is the dark matter of the other 96% of corn DNA sequences.  Too bad Barbara McClintock is not here to help us out.

May 19, 2016

What is a Fair (Cost Effective?) Price for a Drug?

I think a fair price for a drug is a price that would finally generate a return (at least 5% over time) on the investment it took to identify, develop, license, and market the drug.  This includes the cost of the several other "drugs" that the company studied, but were found not to be safe and effective.  Some say only about 1 in 10 drug candidates make it to the market.  I think this is high, if you include candidates that never even make it past the rodent model testing.  In my 15 years in drug development, I think there were two out of about 20 that were licensed by the FDA (but most of these had already been screened in pre-clinical studies). 

This article seems to take a simpler approach - essentially, a "benefit of the bargain" contract approach.  I have an item to offer that is worth $5 to me.   You want the item, and it is worth $10 to you.  The contract benefit both parties, e.g., at any price between $6 and $10.  But who will get the most of the benefit of the bargain?  The article seems to say the drug price is fair right up to the point where the buyer gets at least a slightly better benefit than from the available alternatives. 

The "greatest benefit of the bargain" theory may work up to a point.  The inventor discovered something that gives a greater benefit for the price than what was previously available.  The offer of the drug is simply that - an option (not previously available) that gives the buyer more choices.  That's nice. 

However, this model starts to fall apart when poor people's lives are at stake and the marginal cost of manufacturing a pill is a small (ignoring the cost the maker incurred to develop the pill).  If we force the maker to sell the drug at a price not allowing recapture of development costs, this inhibits the development of new drugs that will save lives in the future (Who cares?  We won't even know who they are.).  Should we proudly force the owner to sell the drug at a lower cost (with the un-measurable loss of lives due to future drugs not developed?), do nothing, rob Peter to pay Paul, or have some government (typically someone else's government) pay the difference?

May 18, 2016

Many 3D Printing Patents Expiring.

Wow.  Really?  Patents expire and the inventions are donated to the public domain?  The mean people do not keep them?  

Listening to the media you would think these important patents would be "evergreened" into the next millennia, with minor improvements retaining control of the technical field (doesn't work).  Of course, the inventors have patented specific improvements to the technologies, and published them for everyone else to make further improvements.

For most patents, the invention is merely a concept at the time of patent filing.  There are years of reduction to practice.  And, the inventor is working on patent prosecution, licensing, and marketing for the first half of the patent term.  So, the inventor is lucky to have a product to protect for only half the patent term.  Alternately, the inventor can not afford the cost of development so is searching for an investor, or buyer (evil patent troll).

Anyway, it seems the basic 3D "printing" technologies patents are expiring.  Time for you to go out and make your own 3D printer.  Don't be surprised if you stumble upon patentable improvements in the process.

May 17, 2016/p>

Metabolic Attack Approach to Cancer Therapy Reconsidered

Instead of attacking a cancer cell's ability to divide (e.g., nucleotide analogs or radiation), another approach can be to attack the cancer cell metabolism. 

This seems a problematic approach to me.  It is suggested some metabolism attacks on highly metabolizing cancer cells can have minimal side effects.  But, blocking the Krebs cycle with a poison, such as 3-bromopyruvate, seems like a touchy approach.  What normal high metabolism cells would also be at risk - heart, brain, marrow? 

Realistically, the article does not suggest these cancer treatments would be a cure. The best hope for these therapies is apparently to keep cancer smoldering in the background. 

May 16, 2016

Nitrogen Fixing Bacteria Spreading Under Our Feet in an Ocean of Soil

Thanks UC Irvine.  We have such a limited understanding of soil microorganisms that if the makeup of soil populations is changing, we wouldn't know it.  Hopefully, nothing bad is happening and we just don't know it, yet. 

The number of species in a milliliter of ocean water has been studied for several years now.  Boy were they surprised when they detected a huge variety of ocean microbes (and viruses) as signaled by the presence of their nucleic acid sequences.  I wonder how they are all interacting with each other in those strange mixing suspensions.  While it may be possible to culture a few ocean microbes in a laboratory, there were many times more detectable only by their DNA sequences.  I wonder if similar studies have been done with soil.   

Anyway, it would be nice to find competitive nitrogen fixing organisms, particularly those that can be symbiotic with agricultural crops. 

May 13, 2016

Does "Marching In" Reduce Drug Costs, or Drug Availability?

The Bayh-Dole Act allowed, e.g., universities to license out inventions supported by government grants.  The schools themselves certainly are not in a position to manufacture and market drugs.  The Act has been more successful than anything that came before in getting the most useful drugs off paper and on to the market. 

Even after a drug discovery is "supported" by the government, there are even greater expenses involved with many drugs, such as FDA licensing, product development, and marketing.  What licensee would take these risks and pay these expenses if the government could just "march in" at any time?

To many it sounds good politically for the government to be mean to the bad guys that charge too much to save lives.  And, if the price were causing a health emergency, the government could march in under Bayh-Dole.  But, suppose they did march in?  Wouldn't they look silly?  Is the government going to make the drug?  Would they be able to find another company interested in walking into that unpredictable mess, and manufacturing at a lower price?  Usually not. 

This reminds me of the "march in" rules in India.  They have only been used once, because it is so impractical to take over drug manufacturing from someone else. 

The Bayh-Dole Act works fairly well because it is predictable.  No amount of political grand standing, and fist shaking at the drug company fat cats will make this difficult business of pharmaceuticals work more efficiently.  Threats from government will usually only reduce the number of competent manufacturers willing to license from universities and make great efforts to possibly bring drugs to the market. 

May 12, 2016

Variable Displacement Engine

I had the same idea, but I was going to change the bore sizes instead of the stroke ;).

May 11, 2016

Value Returns to Diagnostics Patents!  New PTO Eligibility Guidelines Find Biologic Phenomena ARE Patent Eligible.

The new Patent Eligibility Guidelines ( http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf ) seem to actually read the Supreme Court (SCOTUS) holdings. on proper subject matter.  That is, you can not monopolize a natural phenomenon, but you can put it to a specific practical, inventive use. 

Also see the Director's comments at: http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-memo.pdf

Reading the new Guideline examples, has blown my mind.  For example, I saw a list of seven example diagnostics claims (see Guidelines, page 10) associated with a disease-correlated protein, and I knew that an Examiner would reject ALL the listed claims.  I figured I could eventually obtain an allowance (on Appeal) maybe for the claims requiring a specific antibody for detection of the protein.  Then, I got to the punch line ... 6 of the 7 examples were deemed subject matter eligible!  Even claim 1 is eligible where the protein is merely detected using an antibody.  Such a claim would NEVER be allowed, before issuance of these new Guidelines. 

Frankly, in the last couple of years, the Patent Office has been abusing biotech inventors.  My Firm has been receiving a lot of section 101 patent eligibility rejections wherein the phenomenon (or an unusual combination of several phenomena) were elements of focused methods employing a non-obvious combination of specific steps.  According to previous USPTO Guidelines, the claims should have been considered eligible because the eligibility factors were heavily weighted for eligibility.  That is, the claimed methods only covered a small portion of the possible uses of the identified natural phenomenon, and the combination of steps in the claimed method were inventive (as shown in my strong fact-based arguments against section 103 obviousness rejections).   The Examiners continued rejections.  I talked to the Examiners and they told me their hands were tied and they can not allow my claims in the present political environment. 

The SCOTUS in their patent eligibility decisions had focused on the policies of not allowing monopolization of a natural phenomenon and requiring the claims to be "inventive".  Still, the USPTO was rejecting diagnostic methods focused on a narrow use of a natural phenomenon, wherein the method steps were non-obvious.  (Am I repeating myself?  I am soo excited!)  These new Guidelines suggest the USPTO heard the cries of the biotech industry.  And, maybe they actually reread the SCOTUS cases Mayo and Myriad,, noting the whole universe is a natural phenomenon but eligible inventions must be creative and must not monopolize natural phenomena.   

My strategy has been to make the strong arguments on a final Response, and Appeal Brief.  I have told clients that the Patent Office has been misreading the holdings of the Supreme Court (SCOTUS) cases and the pendulum should swing back to something reasonable (or Congress may step in) in the next few years.  Meanwhile, with the backup at the Patent and Trademark Appeal Board (PTAB), it could easily take 3 years to receive an Appeal Decision in their case.  By the time the PTAB picks up their case, the environment would most likely be more favorable to the eligibility of their claims. 

Well, these new Guidelines suggest the wait for reasonable eligibility review may have come a lot sooner than I expected.  I actually have Appeals Briefs awaiting Examiner's Answers.  Maybe, I should file Supplemental Briefs.  With these new Guidelines, there is a good chance the Examiner will drop the Appeal, and negotiate an allowance. 

Further, previously issued patents may be safer against invalidity attacks, e.g., in i>inter partes review (IPR). 

A bright new day for biotechnology/diagnostics inventors?

May 10, 2016

Another Fanciful Electric Light Sport Airplane

Where is the center of gravity on this thing?  Good thing it has the pop out ducted fan canards.  Looks like there is a bit of a lifting body function too. 

----------

F35 Fighter Jay AOA Better, but Criticized. 

F35 has a wider controlled angle of attack range than F16.  Publicity for the F#% has been so bad lately (e.g., with regard to ground attack compared to the A10) that even a good thing is being criticized. 

May 9, 2016

Microwaving Diabetics in Non-Invasive Blood Glucose Assay Device

OK, various resonant circuits in proximity to conductive fluids can be influenced by the fluids resistance (e.g., reluctance, dielectric properties).  I suppose a salt solution (human serum), changes in resistance depending on the amount of sugar in it.  I believe the assay must be non-specific to glucose, and highly influenced also by the amount of fat, water, and/or salt also present; and by the topography of the interface between the skin and sensor.  The glucose only "specifically" detected, if all the other variables can be held constant.  

I found several articles since 2010 where microwave radiation was used to measure glucose in water or serum in vitro.  See, e.g., : http://www.sciencedirect.com/science/article/pii/S0956566314008197   The detectors were immersed.  In this article, I can't find a description of how the device actually works, but I bet they have big problems with calibration on more complex in vivo environment of a patient's skin. 

I assume, the changes in body fluid resistance to the microwave interrogation caused by glucose concentrations are small, against a large background of responses from other materials in a patient's body.  Detecting a change in a large signal is not an ideal situation for an assay (a positive signal against a zero background being more desirable).  So, this is a challenging assay, e.g., with non-specific background signals varying with, e.g., the density of the human tissue adjacent to the "biosensor", and factors, such as hydration of the patient. 

They may eventually get this to work, but I have more hope that "non-invasive" glucose assays not using Blood to work better with Sweat and Tears, as samples. 

May 6, 2016

Triplet Modification Mechanics Stopped Amino Acids at 20.  Why These 20? 

The triplet code has room for 63 amino acids and a stop codon.  Why do we have only the  20 amino acids (AAs) and three stop codons?   Why didn't any of the 20 change to alternate AAs between species (given the billions of years available)? 

Near as I can tell, Saint-Leger, et al., (published - http://advances.sciencemag.org/content/2/4/e1501860.full ) noted that the eukaryotic family of tRNAs and aminoacyl-tRNA systhetase (RS) families evolved to work with a deamidase dimer based on a prokaryotic tRNA-specific adenosine deaminase (TadA).  The eukaryotic deaminase has limited potential in its ability to deamidate the mRNA triplet code third base.  (Unless I misunderstood this on reading the article twice.)  This does not seem to answer any of the questions for me. 

I have prosecuted many patents relating to incorporation of unnatural amino acids (UAA) into peptides with orthogonal tRNA/RS pairs (see, e.g., https://www.google.com/patents/US7915025?dq=7915025&hl=en&sa=X&ved=0ahUKEwjZnrKq28DMAhUQwmMKHVRWDpcQ6AEIHTAA ).  Working with the Schultz portfolio at Scripps, I believe there have been at least 40 different UAAs that we have described.  The possible UAAs seem to be limited mostly by steric hindrance and failure of the ORS libraries to provide good interactions with some UAAs in the binding pocket.  That is, it seemed possible to get any number of strange UAAs to functionally interact with an ORS.  The orthogonal tRNAs seemed very flexible.  Sometimes the ORS could charge tRNAs with more than one different UAA (lack of specificity), but the ORS did not significantly charge with any of the 20 natural amino acids.  Do you suppose the lack of adequate selectivity is the evolutionary burden to difficult to cross?

So, I wonder, in 3 billion years, we have been stuck with the number 20 for possible amino acids (apparently addressed in the Saint-Leger article), but why the same 20?  Is the same mechanism that limits the number of "natural" amino acids the same mechanism that prevents the selection of natural amino acids from changing?

Can anyone read the article and explain it in two sentences?  Any answers to the many questions I am asking?

May 5, 2016

The Lack of a Problem with GMO Does Not Prove There Has Not Been Enough Research

Regarding GMOs, "[i]f a problem is not clearly disproved with scientific results, it is no longer considered a threat," Knirsch said, voicing fears.   

This statement says it all.  First, it starts with the presumption that the problem actually exists.  Then "it" (the problem they know exists, but can't be proven not to exist) can't be called a threat.  So, we have to be exposed to "its" horrible (undefined) dangers.

Why can't Knirsch show there is a problem?  [Because there are mostly  none.]  Then, it could be addressed.  But it is ridiculous to require the feared (and probably nonexistent problem) to be shown before a GMO can enter the market, only to be removed as dangerous.  If there is a problem identified, then it must stay out of the EU.  If there is no problem, then it must be kept out of the EU until the problem is identified. 

Everything in moderation.   Everything has a risk benefit ratio.  The perfect can not disqualify the good. 

For example, if cattle are fed a trillion bushels of GMO corn for 10 years, and no one can find a problem, the benefit probably outweighs the risks.  If a problem were eventually found (and there will be some) it is more likely the problem is small.  But, the lack of an identified problem does not prove that a problem must be found. 

May 4, 2016

Update on India Status on U.S. IP Priority [Bad Actor] List

India has made some headway with protecting IP of Developed countries.  Still India stays on the list of potentially abusive IP practices (e.g., stealing medical intellectual property).

As long as the drug developers do not have valid patents in India, India should have a right to manufacture the medicine for Indian use, and even for other countries where the drug is not patented.  However, I guess the U.S. has India on a watch list of potential abusers, in that it still seems possible (depending on the swing of Indian politics) that infringements could not be prosecuted in India or unreasonalbe compulsory licensing, and unreasonable characterization of inventive drug improvements as "evergreening" (which I argue does not actually exist, since the original product is dedicated to the public on expiration of the patent). 

May 3, 2016

Key White Light LED Patent Found Obvious Near Expiration Date. 

This is a Federal Circuit Appeal from a Decision of the Patent and Trademark Appeal Board (PTAB) on an ex Parte reexamination of white light LEDs of Cree, Inc.  See the Fed Circuit holding at: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1365.Opinion.3-17-2016.1.PDF

The Cree patent (U.S. 6,600,175 - https://www.google.com/patents/US6600175?dq=6600175&hl=en&sa=X&ved=0ahUKEwimxaGYwbnMAhVHz2MKHfrKAAoQ6AEIHTAA ) was filed in 1996, claiming down converting shorter LED wavelengths to multiple longer wavelengths to produce white light.  This is the revolution that made modern LED ambient lighting practical. 

Obviousness rejections on reexamination were based on a primary reference that used a blue laser shining on multiple phosphors to generate black and white images on a screen.  Secondary references taught that short wavelength LEDS can be down converted to optional primary colors. 

The rejections by the reexamination Examiner and PTAB seem a little conclusory.  I assume they had a "gut feeling" the claims were obvious in hindsight.  Or maybe they are not sophisticated enough to make the logical arguments they could have made, e.g., based on application of facts to law. 

The continued rejections were only aided by the weak counter arguments.  For example, Cree suggested the white LEDs were not obvious because down converting through multiple phosphors in a single LED was inefficient and not preferred in the prior art.  Such arguments reek of desperation.  Just because a known technique is not the best technique does not make it unobvious. 

Then, there is the continued PTO/PTAB disrespect for the Graham v. John Deere  secondary factor evidence against obviousness.  The PTAB was not convinced that willingness of licensees and commercial success showed non-obviousness.  Also, I am not sure why Cree did not suggest "long felt need" evidence, since more than 20 years passed between the filing of the references cited in the rejections and Cree filing their application.  If it was so obvious, why didn't someone file an application and commercialize white LEDs in the interim?

It is also not clear to me what will be the financial consequences.  If the patent is invalid now, so it was in 2003, when it issued.  Cree has been able to reap the benefits of the "invention", license payments, and exclusion of an unknown stifled number of competitors, all this time.  I wonder what their licensing agreements said on this contingency?  Punitive damages would seem unreasonable, since they probably believed the patent was valid (as did the licensees).  Cree does not owe anything to companies that declined to enter the market, based on the patent.  Seems Cree may have made out OK, but for the loss of the last 4[?] years of their '175 patent.   

May 2, 2016

What is a Quality Patent Application?

I think a Quality patent is one that is granted and protects the owner's interests.  At the time of filing, it is often hard to know what challenges the application will meet at the Patent Office, and how competitors might challenge in the market place.  So, a quality patent needs to have at least a broadly descriptive specification.

A quality specification will describe the invention the owner wants to sell in the market place.  Sometimes I have trouble explaining to individual inventors of small businesses that the application also needs to describe embodiments they do not want to practice.  This gives flexibility to support claim amendments around surprise prior art during prosecution, and an opportunity to file a continuation with claims blocking a competitor's engineer around. 

Taking it further, good Figures are important to support aspects of the invention that may not be in the specification text (drawings tell 1000 words), and are required to show all elements of a device that are mentioned in the claims.  Multiple examples are important to fight enablement rejections, particularly in Asia and Europe. 

Finally, it can be important to customize your application depending on what foreign countries are intended for filing.  For example, for European applications, I often expressly separately describe combinations of features (e.g., a1/ba/ca; a2/b1/c1 ...a2/b3/c3 ...) because of their ridiculous position (in subject matter rejections) that one of skill would not know that expressly listed species of genera can be combined in a variety of combinations and permutations.

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