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Gary Baker, Esq., M.T.
BioPatentSm IP of Quinelaw
Intellectual Property and Biotech Blog
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Many articles talk about what happened, without touching on the how or why.
This blog is intended to fill in legal, technical, or political background information left out of the stories.
Please read hyperlinked stories, then my insightful comments!
Comments herein are opinion and not to be relied on as legal advice.
April 29, 2016
lcnRNA Double Strand Break Repair Mechanism Protecting Resistant Cancers
Certain cancers, such as triple-negative breast cancer (TNBC, negative for select therapy targets), are also resistant to attacks on their DNA because of a DNA repair mechanism that is up regulated.
In this article, it is suggested these cancers can be less devastating if we can find a way to inhibit the DNA repair known to use the long-encoding RNA (lncRNA) mechanism.
Seems there would be side effects too, but acute therapeutic attacks on the target cancers are probably a risk worth taking to close down this DNA repair mechanism protecting the cancer.
April 23, 2016
Another Chance for Diagnostics Patent Eligibility at the Supreme Court?
The unanimous Supreme Court (SCOTUS) case of Mayo v. Prometheus was bad law based on bad facts. The claims (poorly written and confusing) were essentially directed to detection of metabolite levels (ironically of an unnatural drug) in a patient to see if the drug is in a therapeutic range. Now, we have to live with this unusual fact pattern for comparison in determining patent eligibility for diagnostic tests.
From Mayo came a set of Guidelines at the Patent Office (http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf ) that should have been good news. The SCOTUS had at least laid out policy priorities from which weighted factors were to be considered in evaluation of eligibility. Key among these factors were "inventive concepts" (non-obviousness) providing something more to the natural phenomenon, and lack of natural phenomenon preemption (not monopolizing the phenomenon).
The article suggests that Sequenom may be a good poster child to argue against over recent aggressive findings of diagnostics patent ineligibility. The Sequenom claims are methods specifically requiring a maternal blood sample be split into several reaction chambers and the reactions to be evaluated for the presence of both maternal and fetal chromosomes, and the chromosomes evaluated for aneuploidy. These claims seem far from monopolizing the phenomenon of fetal cells in maternal blood. The inventiveness may be arguable.
See the Sequenom patent at: https://www.google.com/patents/US7888017?dq=7,888,017&hl=en&sa=X&ved=0ahUKEwi8odqTvqLMAhUB1WMKHdTFCo0Q6AEIHTAA
The problem I have seen with the court cases and in prosecution of diagnostics patents lately is that the Examiners and Judges seem afraid of Mayo and do not even attempt to apply facts to the guideline factors. They just wave their arms and say there is a natural phenomenon analyzed by well known techniques. I have had some recent cases where the claims are focused on a particular use of a natural phenomenon taking up not even 1% of the phenomenon uses; and where the obviousness rejections of the claims are unsupportable. I have discussed the cases with the Examiners and they have told me their hands are tied by Mayo and Sequenom. It seems to be an unwritten policy of the PTO to ignore the weight of facts in their own Guidelines.
My strategy for these cases is typically to draft very strong Appeal Briefs, using the facts and Guidelines, and hoping for a more friendly environment by the time my cases are actually decided by the PTAB (about 3 years).
With time, the pendulum may swing. More cases may go in the favor of diagnostics claims and Examiners may not be so frightened standing out from the crowd with an allowance. The policy issues of non-preemption and inventiveness may be given more respect. Importantly, maybe the Court or Congress may see the important policy issues of saving lives and keeping the U.S. at the forefront of diagnostic technologies.
April 20, 2016
Deliver My TP Over the Top, Please
The last word (actually, first word) in how to load a toilet paper roll can be found in the original patent: https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US465588.pdf
Well, Mr. Wheeler did not actually patent the method of mounting a TP roll, or even perforated TP rolls, but only those with serrated perforations with a central trapezoidal tongue.
However, it is clear from the drawings that TP pioneers were on the right side of history on insisting the roll egress over the top.
April 19, 2016
GMO Plants Get a DoOver in Court of Public Opinion Thanks to CRISPR
USDA did not review a non-browning mushroom and a waxy corn as biotech products since they did not contain a foreign gene, and were transformed using non-randomized insertion. The USDA said the CRISPR-edited mushroom doesn't contain any "introduced genetic material" or foreign DNA. See article at: http://www.businessinsider.com/the-us-government-says-crop-edited-with-crispr-wont-be-regulated-2016-4 Hopefully, the position of the USDA scientists will result in a fresh image of laboratory modified plants.
Scientists are basically in agreement that thoughtfully engineered genetically modified organisms do not pose a threat, regardless of the enzymes used to modify the genes. Countless trials have not shown harm as food. It seems a lot of the hype from non-scientist journalists against GMOs in the past has had to do with the fact that FOREIGN genes (chimeras!) may have been inserted RANDOMLY (careless Mutations) inserted into a familiar food plant. This unpredictability and ungodly crossing of species has been a significant part of the fear and ick factor of GMOs.
Don't say it out loud, but these plants are actually still genetically modified, as are traditional radioactively mutated plant varieties and cross species hybrids (yes, mules are icky). And, even if the gene engineering is by the old fashioned restriction endonucleases, and somewhat randomly acting expression vectors, the final products can be just as well characterized and screened for theoretical hazards (almost all of which are disadvantageous to the engineered plant and not to the animal that eats it).
What I am saying is that when it comes to safety of restriction enzyme engineered and CRISPR engineered plants, it is mostly a distinction without a difference. It is easier to avoid unintended mutations when inserting with CRISPR, but GMOs made with restriction enzymes or with CRISPR can be essentially the same.
However, just because the USDA gave a blessing of not reviewing this mushroom and corn does not mean they will not be otherwise attacked. I assume they will at least have to include GMO on the label in Vermont if they become an ingredient of a processed food. And ... these products Are dangerous. Yes, non-browning mushrooms may not degrade as fast as other mushrooms and will have an advantage while they spread under our feet to take over the world.
Still I can hope the press will be nicer to CRISPR technologies. Engineers in other fields don't seem to catch as much flack from the press; probably because they don't mess with something that goes into our (and our children's) bodies, and because there is so much nostalgia and romance around food. My bet, though, is that certain journalists (usually non-scientists) will continue making a living cultivating the villain image of laboratory adjusted organisms.
April 18, 2016
India Realizing Compulsory Licensing of Patented Foreign Drugs is Impractical
India is apparently backing off, for now, on the threat of compulsory licensing for patented drugs it feels are over priced. India's Commerce Ministry had forced one compulsory license. More recently, the Petitions by Indian generic drug manufacturers were not granted with the Ministry finding the Indian generic drug manufacturers "did not make a strong enough case". Interestingly, there have been allegations that certain staff of the Ministry had suggested to foreign pharma that they would not be granting compulsory licenses for commercial use (leaving open emergency government use). The Ministry had no comments when information was requested by media on the topic.
It appears that in reality the best way for India to save money and get cooperation is to work with foreign pharma to have drugs manufactured in India. Deals can be made to sell drugs as lower cost in India. Deals can include foreign pharma cooperation in using trade secrets that greatly facilitate manufacture (more similar product without expensive process development research). Further, the Indian government may be realizing cooperative behavior provides a greater net benefit in foreign investment and reciprocal respect for its own inventions (which are expanding).
Another reason there has been no movement on Petitions to require compulsory licensing is that there is apparently a new Indian intellectual property policy statement due out soon. No use taking drastic actions when the rules may be about to change.
With all the fear of compulsory licensing in India and other countries, we may be missing the point that by far the greatest rip off of developed world drug inventions, research, and development costs is price setting by governments in the developed world itself.
April 15, 2016
Diluting the Anti-GMO Brand
Retail food products are hitting the shelves GMO warnings - "partially produced with genetic engineering". What will happen when consumers realize that 70% of packaged food contains at least one ingredient derived from a genetically engineered plant? Of course, they will eventually become habituated to it.
If tell people no one has ever shown adverse health consequences from eating GMO plants, someone will say, "we need more studies." This, even though trillions of GMO meals have been served without harm (far fewer incidents than for many "natural" foods).
But, many people will eventually realize from their own experience that GMO food is not dangerous (unless they are really paranoid and blame every rash on GMO). Real life experience can sometimes overpower fear of the bogyman. That is, the people will be desensitized to the fear of GMOs.
The current laws will only (unfairly) accelerate this desensitization. For example, take soy bean oil. If there is a protein that makes soy resistant to glyphosphate (not typically in the soy, and anyway not segregating with lipids in processing), it would not show up in the oil, which contains zero protein. Even if the protein were present, I assume the protein could be eaten by the tablespoon, without ill effect. Still, the law requires food made with the clearly (and proven) safe oil to be labeled as a GMO product.
There are plenty of theoretical problems with GMOs. But, it is hard to make up reasons not to eat well thought out GMO foods. For example, just because a peanut or tobacco protein is in a GMO food does not mean you will get addicted, or experience a peanut allergy reaction (the protein in the GMO is not the same one known to cause the peanut allergy).
I am not sure where the first amendment argument will go. It does not seem unreasonable to require true information on a food label. However, what if the information conveys unreasonable fear of something harmless? I expect the stronger constitutional argument is that the laws are arbitrary and unreasonable vague (not well tailored to an actual identifiable problem, while forcing speech).
The bigger problem with GMOs is that they divert attention away from the real problems. Who do you know that has been made ill by a GMO? Who do you know that has diabetes or heart disease from eating hamburgers and fries?
Moderation in all things. Balance. What is harder on a family's health - buying half as much expensive organic vegetables, or eating twice as much GMO vegetables with a one in a trillion chance of causing a rash?
April 13, 2016
Danger in IoT for Medical Devices
OK, what is IoT? Oh yeah, internet of things - I must have been an IdioT to have forgotten.
Anyway, with the IT prevalence in medical devices, we all know the time will come when they will be hacked. Probably little will be done until there is a disastrous incident. Data out from individual devices may not be the biggest problem. Who cares what is Jim Johnson's clotting time? Worse would be data in to change John's pace maker parameters.
Usually, it takes an incident to make people take the necessary steps.
April 12, 2016
How Times Have Changed - Wright Brother's Flying Machine Original Patent Rediscovered
The Wright brother's original patent was lost and rediscovered. See the text and figures at:
This is a large patent for the time. The wings are quaintly caller "aeroplanes". The "corners" of the aeroplanes act as ailerons when they are warped by ropes and pullies driven by the pilot shifting a "cradle" on which he is laying. This also shifts the center of gravity of the aircraft, further aiding in the turn. It is interesting at page 4 that the Wrights understand that turning is ailerons and the rudder is intended not to turn, but to keep the axis of the fuselage aligned with the direction of flight. (Note, I am a private pilot.)
At page 5 they explain why they put the "horizontal rudder" (elevator) in the front of the aircraft at a negative angle. Apparently, they intended that this would increase safety by providing lift during stalls to keep the nose up. This does not make sense to me, because a high nose is what causes most stalls. However, this is essentially a canard design and no matter their explanation, is generally more safe if the front wing stalls before the main wing.
Note there are 18 independent claims, ending with "substantially as described."
April 11, 2016
Storing Photos as Ternary Data on DNA Molecules - High Density Storage
The human interest article that mentioned this work was boring, so I had no great expectations. However, once I found the actual paper, I was pleasantly surprised by the careful consideration and initial experiments to store digital data in DNA.
Before I read the article, I guessed at the basic principles and problems, and I was mostly right. Data is stored in short (synthesizable) blocks between PCR primers and barcodes (addresses). To avoid the problem of primer dimers in such a multiplexed environment, large data files of several addressable blocks must be stored in separate pools, e.g., plate wells (though I have a client with certain primer blocking technology that could minimize this problem). Then, there are the problems of homopolymers (difficult to sequence accurately) and hairpins in the stored data.
See the actual research paper at:
What they (Bornholt, et al., UoW) propose is a massively parallel synthesized set of somewhat redundant (error checking) 200 base oligonucleotides with paired PCR primer sites and bar codes (random access addresses). Even with the primer sites designed to avoid primer dimers, they still have to isolate large databases in separate physical pools. Because the bar codes are randomly addressable, the sequencing step does not have to read the entire database to retrieve a particular sequence of interest. This technology seems to be inspired by currently available massively parallel sequencing (Illumina) and synthesizing schemes.
Of particular interest to me was the selection of base 3 as the encoding choice over standard binary or base 4 (natural DNA encoding - A, G, C, T). The choice allows increased data density over binary. More interesting is that the DNA 4th base to be used in a rotating encoding scheme inserting some randomization to reduce the sequence redundancies inherent in encoding images and text. That is, e.g., repetitive data bytes (e.g., orange pixels next to each other in a photo) would encode as homopolymer repeats, which are error prone to read in current sequencing technologies. Rotating encoding algorithms eliminate this as an issue.
Working against the DNA data storage system is an apparent one time use problem. That is, the nucleic acid being read is destroyed, or otherwise unavailable after it has been read. Also, the best (most stable - I used to have a job setting expiration dates of drugs) storage mode is desiccated. Dissolving a pool address, to obtain a particular data block, raises the question of whether to use it all or re-dry the left overs. This all works against the stated goal of obtaining data compactness.
Anyway, this is good progress. Apparently DNA can store 100 million times the best current technology today (probably with about the same size reading devices). This should be no surprise considering the DNA data in one human cell can encode a system of a complex animal with a super computer in her head. We will probably be using molecular data storage for long term storage in the next couple of decades.
April 8, 2016
20+ Amino Acids (Canonical, Unusual, and Orthogonal)
It has been long known that amber, ochre, and opal mutations of stop codon usage occurs naturally, resulting in placement of natural amino acids in place of stop signals.
And, it has been known that certain organisms use the stop codons to incorporate unusual amino acids, such as selenocysteine (UGA) and Pyrrolysine (UGA).
The laboratory of Peter Schultz (The Scripps Research Institute) has long been working with genetically engineered aminoacyl synthetase enzymes and modified tRNAs to incorporate any number of unnatural amino acids into peptides in "orthogonal systems". For example, see a patent of his pioneering work at: https://www.google.com/patents/US7045337
We have all been sucked in by the bio-dogma of the 20 amino acids. I was amazed the first time I read this kind of work.
April 5, 2016
What to Do After Final Rejection of Your Patent Application
I don't amend after final so much these days. Get your amendments out of the way in a good first Response with amendments entered as of right. Sometimes my first Response will be strong, and/or the Examiner's first search weak, so the Examiner has to present new prior art, allegedly necessitated by your amendments of the first Response. Typically, new art would require claim amendments, but they will not be entered after final. Still, I present the amendments and my best arguments at this stage to see what the Examiner will reveal in an Advisory Action. You don't have to make a "showing" have a good reason why the amendments were not made earlier. The Examiner will do whatever he wants in any case (knowing it is usually not worth the trouble to fight, and arguing against finality is heavily biased against Applicant).
One option not mentioned in the article is to file a Request for PreAppeal Review Committee. I find some progress can be made with this option about half the time when the Examiner is clearly making a gross mistake. The "Committee" is usually made up of the Examiner, her SPE, and a third party (not supposed to be in the same Art Group). Decisions never are an Allowance, but often the Examiner is embarrassed into withdrawing the rejections and to make up something new, not as clearly in error. Sometimes, an Allowance is not too far off, after a little administrative face saving.
The After Final Pilot is a good program, because it gives the Examiner points and motivates a second look, e.g., at the claim amendment suggested after a final rejection based on new prior art.
I have been Appealing cases a lot lately, and hardly ever using RCE. If you have not been caught by surprise, there aren't many reasons for an RCE. The problem is that it can take up to 3 years to get back a Decision from an Appeal (which can be returned in patent term adjustment). Appeals are great because they are reviewed by a committee that is not biased and which understands application of facts to case law (Examiner's are not lawyers). Also, I have had several cases where the Examiner was too embarrassed to present his Answer to the PTAB, so he presented a path to allowance, without having to pay the $1000 fee to forward the case to the PTAB.
Write a good specification so you have a basis for amendments, use the right of amendment after the first Office Action to place the case in condition for Appeal, talk to the Examiner early and often (they are mostly friendly and helpful, lately), Appeal when you know you are right.
April 4, 2016
Watch Where You Step When you March In - NIH Threatens to Take Over Overpriced Drugs Based on NIH Grants
Before the Bayh-Dole Act in 1980, National Institutes of Health had all the rights to drugs developed under their grants, but only managed to get 5% licensed for clinical study (and fewer actually to the market).
Now, the NIH may be pushing to use the contracted "march in" rights to take over patents where they deem the manufacturers charge too high a price. It is a great threat, but probably will not happen. Usually, this will be a political ploy to get the inventor/manufacturer to lower their price for the drug. The NIH can't manufacture (probably couldn't based on the information in the patent application alone), and no one wants to take up the burden when Bayh-Dole does not allow for exclusive licenses.
Still, this new NIH position has not helped the price of biotech stocks.
March 31, 2016
"Flexibilities" - Avoiding Drug Patents by Manufacturing in Foreign Countries
Countries that have not invented patented drugs can use a variety of strategies to get the drugs to their people at a reduced price. See WHO report "The Role of Intellectual Property in Local Production in Developing Countries". The non-inventive country can reduce undesired drug monopolies by: placing barriers on patentability, placing barriers to patent eligibility, requiring compulsory licensing, pressuring cooperation from drug owners, and/or engineering around the invention. These strategies are more or less fair, depending on your perspective. A more common problem is that, even for drugs that are not patented in a particular country, most developing countries are not technically or administratively sophisticated enough to reliably manufacture their own drugs. Drug manufacture can be as complicated as rocket science.
It is common for countries to exclude, e.g., methods of medical treatment from patent eligibility, for ethical reasons. And, most countries exclude natural materials, such as unmodified bioactive plant alkaloids (e.g., turmeric extracts), from patent eligibility. Another practice is to prevent extension of patent protection for old drugs ("evergreening") by making improvements to old drugs ineligible for patent protection. This strategy has never made sense to me because when the old drug patent expires, anyone can practice it, even if someone has later patented an improvement. If the old drug was just fine for 20 years, why is there a need to prevent new inventive improvements from receiving patent protection? And, such practices are a two edged sword, also preventing the countries own inventors from patenting improvements.
Even after a valid patent is granted in certain countries, procedures are in place to force availability at a locally reasonable price. For example, governments can establish compulsory licensing schemes where if the government deems availability inadequate, the government can determine what the government feels is fair for the government to pay for the drug. Sounds fair. Or, the government can manufacture the drug themselves and pay a fair reasonable government determined royalty.
I worked in drug manufacturing process development for years. Just because a drug structure is known does not mean you can manufacture it. Process development and scale up are very expensive. Manufacturers have trade secrets that are not necessarily described in their patents or in public drug licensing applications. Even if a patent is not enforceable (e.g., no application ever filed) in a small country, they may not be able to easily begin manufacturing the drug.
Larger countries that may be able to properly manufacture drugs still usually do not start their own manufacturing, for a variety of reasons. Typically it is more cost effective to pressure the invention owner to sell the drug at a discount than for the country to make the necessary expenditures in process development, facilities, and manufacturing. Alternately, the country can pay the drug owner (licensing of trade secrets, patents, and expertise) to cooperate in making the drug manufacturing less expensive and more predictable. More commonly, the countries will set just the price they are willing to pay for the drug (paying only for the marginal cost of manufacturing drug, but not for the cost to discover and develop the drug) and the owner often agrees to the lower price. This does not mean the owner was ripping everyone else off, but that it makes business sense to get the marginal gross revenue (while other customers pay for the research). That is, the country paying the lower price is ripping off the drug owner, by not paying "Their Fair Share" of discovery and development costs.
No matter where a drug is manufactured by the non-patent holder, it typically can not be imported into a country where the drug remains under patent protection. For example, in the U.S. see 35 USC §227(g), wherein it is patent infringement to import a product manufactured by a patented process outside the U.S., even if the product itself is not patent protected.
An alternate route to obtain an active drug is to engineer around the patent, e.g., rather than trying to meet the standard of bioequivalent manufacturing. For example, where a biologic drug patent claim includes a specific protein sequence, one can engineer around the patent by, e.g., changing a valine to an iosvaline in a structural part away from the active site (but watch out for the Doctrine of Equivalents). Depending on the regulations (or lack thereof) in the country, the "new" drug may be licensed with little or no clinical data.
Nobody files drug applications in all 200 country jurisdictions. So, it is legal to manufacture and sell most drugs in most countries, even if patents are still enforceable, e.g., in the U.S. Yet, the drugs are typically not manufactured outside of the patent protected jurisdictions. This is because there are many barriers to drug manufacturing besides the presence of an enforceable patent.
March 31, 2016
Copyright Protection with Synthetic DNA
These ideas have been going around for a long time. I thought the idea of putting bar coded nanoparticles in paint or valuable powders was a good one.
This idea is not well described in the article, but probably involves embedding DNA oligomers in the art media or an attached tag. I believe I heard the same idea at least 10 years ago. It probably came up again because useful detectors of DNA sequences have become more practical in size, cost, and speed.
But, who needs fancy "synthetic" DNA, I am going to kiss all the arrowheads in my collection, leaving my own DNA to show ownership. This is a major step up from the way dogs and cats have done it for centuries.
March 29, 2016
Food Processors Beginning to Label GMOs - Gone Will Be the Dread
As goes Vermont, so goes the nation.
Once GMOs are labeled, there will be no hidden mystery and the irrational fear will probably melt away. We have all been eating large amounts of GMO foods for years, to no ill effect, but it has not been up front.
No one puts even theoretically hazardous proteins in food plants for people. The sooner GMOs become everyday in the eyes of the consumer, the better.
March 28, 2016
China Files a Large Nomber of Patents - Wow
What an annoying article. Such puffery and misleading statements.
The first sentence is ridiculous - "The economy is not the only area in which China has claimed the top spot." ??? China has a number 2 economy. The U.S. economy is three times the size of China's. Note that if the U.S. grows at 3% and China grows at 9%, they still would never catch up (well, OK, considering that such growth must be sigmoid).
Sooo, China has a command economy with a "five year plan" to produce a number; a propaganda goal of Issuing a larger Number of patents than anyone else. Half are "model" patents that shouldn't be equated with, e.g., a Utility patent. It's like saying you are the greatest food producer because you raise a larger number of chickens than the number of cattle your neighbor produces. Wow! What a large number you have. But, you should see how many bacteria I have.
Yes, China is growing and has a lot to be proud of, but it should be beneath their dignity to Invent superlatives.
March 25, 2016
The Relative Carbon Burn for Electric Versus Internal Combustion Cars - Tesla Gross Polluter Fine
It seems electric is about 2/3 as carbon intensive as gasoline cars. Not as good as most people think.
They did mention that the production of the batteries for a Tesla is very energy intensive (e.g., mining, transporting, purifying, compounding, assembling). Even for gasoline cars, I have figured it takes about 2000 gasoline gallons equivalent to manufacture a new car. Assuming someone buys a new car every 10 years, I have saved more than 9000 gallons of gasoline equivalent by driving my 45 year old Datsun 240Z (sorry it is carbureted).
March 23, 2016
Another Previously Harmless Bacteria Attacks! - Elizabeth the King
Remember when Serratia was just the pink slime in your shower? Now, a dreaded pathogen.
This article is about a widely dispersed gram negative rod Elizabethkingia anophelis, named after Elizabeth O. King, who first isolated it (grows well on blood agar) from a meningitis patient in 1959.
Well, it is resistant to antibiotics. What's with that? The bacteria has hardly been exposed to antibiotics in human patients. I wonder where else it may have been exposed? Hmmm, it is widely distributed in water and soil. It would be interesting to see what plasmids are in these resistant Elizabethkingia and where they may have come from.
March 22, 2016
BSE, CJD, Alzheimer's, Prions
Good the transmission (not actually Alzheimer's) is through surgery, and not a more common route. Thankfully, the article is not suggesting a more transmissible route as in CJD or BSE.
I was raised on wild meat as a child and had some small concern about studies years ago about possible transmission from deer to human through eating neural tissues. Still is not a good practice to eat your deceased ancestors (as in the Creutzfeldt-Jakob disease).
March 21, 2016
The Curse of Our Neanderthal Genes
Hmmm. Bad gene. Correlations. Thank god they called the identified negative phenotypes "associations". Got to love scientists. If the article were a general circulation newspaper, journalists would say the genes cause the problems. Right. One gene causes depression or tobacco addiction. Great. I happily have 1.5% Neanderthal genes and tobacco makes me sick. Darn my brow ridges, though.
Must humans play the victim in every interaction? If the Neanderthal contributions were so detrimental, how come they were the genes we retained from our ancestral indiscretions? Just look what OUR gene contribution to Neanderthal did to them; they're extinct!
March 17, 2016
Same Pain Time, New Pain Channel
As with cancer, there is no one trick solution to pain. The biophysical networks in the body are so complex, you often can not block a pathway without the body finding an alternate route to get a message through.
My wife is a neurophysiologist in the field of pain for many years and she knows first hand that a single small molecule drug is probably not the answer to chronic pain. There is hope, though, that a combination of drugs may block a main and alternate pathway to pain.
March 16, 2016
Meta Data May Be Maxi Biased
Metadata is data reviewing a compilation of other data (boring). It can be a powerful tool in science because it can take the data from various related studies and make statistical inferences from a larger population pool of information.
We have all heard that positive results get published but negative results do not. We have also heard that a large portion of published research results are not repeatable. This is not only in the field of psychology. However, when results of related studies are biased toward a positive result, so too will be the metadata.
In hindsight, it is obvious that the bias in result publication would have a significant effect on the reliability of meta-data. Darn it. I used to like metadata.
March 15, 2016
Origami Inspired Surgical Devices
The devices are "origami inspired". The grasping device is made of stainless steel but seems to have done away with cables and pin joints.
I still want to see an example of a device that unfolds after insertion.
March 9, 2016
Wholly Distinctiveness Batman! Batmobile Character Copyright Affirmed
The copyright infringer was manufacturing full sized Batmobiles and selling them for $90k. The defense was that a car can not be copyrighted, and that there is not enough uniformity between the various comic book, TV, and movie Batmobiles to compile them as a distinct copyrightable work.
The Courts have found that the Batmobile "character" need not have a consistent appearance in every context, so long as the character has distinctive character traits and attributes.
See the case at: http://cdn.ca9.uscourts.gov/datastore/opinions/2015/09/23/13-55484.pdf
There are no fine lines in copyright infringement. In some cases, exact replication is required. Other times, infringement only requires production of a work having a combination of distinctive traits. It did not help here that the derivative works were unarguably intentionally profiting on the Batman context.
How many Batmobiles would one have to sell to pay costs of this lawsuit?
March 8, 2106
The Diverse and Unexplained World of Bacterocins
OK. What is that black fungus growing out of the glass bowl in the article (answer below)?
The author notes that antibiotics have long been thought to provide a competitive advantage by killing or inhibiting competitors. I still think this must be true.
However, antibiotics are generally unstable and exist in only very low concentrations, e.g., in soil. So, they say, could not provide an advantage. One scientist suggests antibiotics actually "might serve soil bacteria as sources of carbon and nitrogen; in this case inactivation [of antibiotics] (resistance) is really just digestion." I don't think so. Why would one bacteria provide nutrition to the environment, and why would the nutrition be configured (at great metabolic cost) to fit so neatly and inhibit, e.g., specific transcription complexes?
Iron. So important for growth. Remember the guy who wants to solve global warming problem by dumping iron into the ocean (causing algae blooms that drop to the ocean floor)? This article says that there is only one atom of iron per 1.6 liter of blood (clearly not counting RBCs and transferrin complexed iron), thus inhibiting growth of microbes in our blood.
It is said that iron receptors in bacterial membranes should be a good targets to inhibit growth without promoting resistant mutants. I don't see why the iron receptors should be refractile to functional mutations. However, in the study, a 70 generation (20 hours?) selection of Pseudomonas for receptor mutations did not seem to enrich for any cells having alternate means to obtain iron from the environment. Still, I am not convinced that Pseudomonas could not develop strong resistance to iron receptor inhibitors, given time.
Iron filings in the presence of a strong magnetic field.
March 2, 2016
Butt Implants Rising
Apparently, this procedure is really big in Brazil.
Best to get it done professionally. There have been silicone injection parties where industrial silicone gel was injected by amateurs to give the full round look. Accidentally injected into a blood vessel, "patients" have been killed. More commonly there is an imbalanced look, and plenty of discomfort.
March 1, 2016
Carotid Stents Equivalent to Endarterectomy (Reaming?)
I assume the patients with narrowed carotid arteries were randomized. Off they go to highly skilled surgeons to perform endarterectomy or a stent expansion. The data show each group had a 7% chance of stroke over 10 years. What is the percent in a control group?
I suppose the stent is placed by way of the brachial or caudial artery. Not so invasive.
The arterectomy may have been by reaming, but this can send particles into the brain. The other method, I found is the eversion method where the narrowed section of artery is removed from the patient, turned inside out and scrapped, then turned inside in and reattached. Wow, and this had the same percent strokes after 10 years. Seems the convalescence and complications would be worse with the endo-art-ec-tomy.
The patients had only 1% restenosis in both groups. This is much less than the average for coronary artery restenosis (30%?).
Then there is the fact that 90% of the treated patients were asymptomatic. In countries with socialized medicine, they elect to have far fewer such treatments for asymptomatic carotid occlusion. Could it be that surgeons are churning people's insurance accounts in the U.S. with little or no benefit to the patients?
February 29, 2016
A New Target for Antibiotic Attack?
Well, the article does not reveal THE "mechanism by which drug-resistant bacterial cells maintain a defensive barrier." Yes, the lipid barrier of gram negative bacteria, and almost any cell, is part of innate resistance to foreign substances (try to get an antibiotic through the thick acid fast lipid coat of a Mycobacterium).
This has little to do with multi-drug-resistant bacteria. Multiple resistance factors, like those often found in the gram negative Pseudomonas, are typically proteins encoded by readily transferred plasmids. The proteins do things like bind to antibiotics or enhance their removal from the cell. Other mechanisms of resistance can include mutations in antibiotic targets like ribosomes.
It is nice that the beta-barrel assembly machinery (BAM) pentamers are important in insertion of other proteins into membranes. Hopefully, molecules can be found to specifically obstruct the gram negative cell BAM. It is not promising that similar BAMs are found in mitochondria (a side effect waiting to happen).
February 24, 2016
Lack of Coffee Causes Cirrhosis (Just Kidding)
A meta analysis has determined that there is a strong correlation between drinking of [black?] coffee and a reduced incidence of liver cirrhosis.
I do appreciate that the authors speak of an "association" and not causation. In fact they note that there is no proposed mechanism (mode of action; hmmm ... how about antioxidant benefits?) and the data are based on self reporting of the study participants. It would have been nice if the studies had also included control for, e.g., self reported alcohol drinks per day.
I was impressed that they reported "there may be an upper limit beyond which there is no further benefit". Darn! I was hoping that if I drank 20 cups of black coffee per day, I might actually grow a whole extra liver.
Mormons are not supposed to drink coffee. I wonder if they have more cirrhosis?
February 23, 2016
Medical Technology IP Protection in Asia is Difficult, But Improving
Asia can be a difficult place to protect intellectual property. For example, there is typically no protection available for medical treatments or use of medical devices for treatments. In most Asian jurisdictions, there is no grace period after offers to sell, claim scope is often limited to the embodiments described in the patent application, there are poorly defined inventiveness standards, a need to have a local presence, and spotty enforcement.
For example, while one can patent a concept in the U.S., the issued patent claims in China are often directed to actual reduction to practice - claims focused on working examples provided in the Examples section of the application. However, many clients continue to prosecute cases in China because they are a large and expanding market, and in the hope that the issued claims will ultimately be enforced at a scope similar to the Doctrine of Equivalents in the U.S. That is, as Chinese jurisprudence and controlling case law develop, there is hope that enforceable claim scope will be the literal claim scope plus obvious modifications, e.g., employing equivalent features with the same function in the same way for the same result.
Arguments against obviousness rejections are fairly well developed in the U.S. However, "inventiveness" (the rough equivalent of obviousness in Asia) can be even more arbitrary and subjective. For example, in China "inventiveness means that, as compared with the technology existing before the date of filing, the invention has prominent substantive features and represents notable progress". Prominent substantive notability - probably something is lost in the translation, but it gives you a clue of the flexibility Examiners have to reject claims in China.
Overall, there is a clear trend of increased fairness in the Asian patent jurisdictions. I believe this reflects the fact that Asia has more creativity to protect, so must provide protection to get protection (reciprocity).
February 22, 2016
SCOTUS May Hear Case on When Generic Biologic Can Be Marketed
I am no expert on the history or facts of this case concerning the first generic biologic drug to market at expiration of a drug patent under the Biologics Price Competition and Innovation Act (BPCIA). It seems the policy reasons behind the law would mandate allowing the generic manufacturer to obtain a license and start marketing the drug immediately at patent expiration, unless the patent holder can show the generic product would be infringing a valid and still enforceable patent.
The wording of the law says:
"The subsection (k) [generic] applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)."
I do not see why this can not be interpreted to allow the generic manufacturer to give notice of intent to market the patented drug, e.g., 181 days before marketing begins, even if the drug is not yet licensed. If the generic drug is licensed after 181 (or even 600) days, the generic manufacturer would be "marketing the biological product licensed" after the waiting period. The licensed product would be marketed after the 180 day notice period. If the biologic were licensed before 180 days, they would have to wait a little while to market. (They might also have to wait to begin manufacturing, depending on the patent claims.)
With the 180 day notice (most of which would be concurrent with the final days of patent term) the manufacturer can begin marketing the licensed product. With the 180 day notice, the patent holder has time to make a case for an injunction, if appropriate.
The statute does not seem to guarantee an injunction. An injunction generally requires the petitioner to show facts, such as: evidence there is a substantial likelihood of success on the merits of the case. The patent holder has to show FACTS supporting the position, e.g., that they have a valid patent that will still be enforceable against the generic drug, after the patent has expired. This seems like a hard argument to make.
For example, the expiration date of the patent may be incorrect, due to confusion in the context to the new America Invents Act (AIA, "first to file") law or an incorrect patient term adjustment (PTA) calculation buy the Patent Office. These issues should be easy to resolve. Maybe, the patent holder has another patent covering the drug, e.g., an improvement in manufacturing process or drug formulation. In such a case, the generic manufacturer could still manufacture the old licensed drug that is going off patent. If there is a later filed (and later expiring) patent touching on the generic drug intended for marketing, the generic manufacturer should have practiced due diligence and not attempted to manufacture before ALL valid patents to the drug are expired.
Do not consider my comments as legal advice. I have not watched the BPCIA cases closely and may be missing something. Any comments from experts?
February 20, 2016
Update on Preparation of "Gasoline" From Algae
I haven't followed the fuel from algae technology lately and didn't realize they had attained such high efficiencies in total useful solids and fuel component recoveries.
The fuel production process Scenedesmus acutus green algae biomass having 41% lipid content and 38% sugars (mostly as polymer). See the journal paper at:
The fuel extraction process includes an acid pretreatment to hydrolyze sugars from polymers, fermentation to produce alcohol, distillation to harvest alcohol, and hexane phase extraction to harvest fatty acid lipids.
The improvement in the article is to ferment (Saccharomyces cerevisiae) before removal of solids, thus recovering sugars that would have been lost in the solids, and avoiding the solids recovery (centrifugation or filtration) step.
Overall they claim about 88% recovery of fuel from the biomass. This seems to be about 700 pounds of fuel (97 gallons) from a ton of biomass (which includes the water weight in the cells?). Still, there is a way to go at $10 per gallon of fatty acid/ethanol "fuel" (which seems to require additional processing to actually be fuel for a car).
I wonder what they can use the
process waste for (potassium, phosphorous, metals, [proteins?])?
Looks like fertilizer for the next round of algae growth.
Looks like fertilizer for the next round of algae growth.
I guess someone has long ago figured out that it does not make sense to just dry and burn the algae in a furnace to make carbon zero electricity.
February 18, 2016
Another Study Showing No Correlation Between Cholesterol Intake and Heart Disease
Again, they say you can eat eggs without increasing your morbidity/mortality risk. The study had a moderate number of test subjects tracked over 21 years. However, this was not a stress test of dietary cholesterol consumption with only a half gram per day consumed on the average. No statistical risk was detected.
One egg a day is OK. Moderation in all things.
How many eggs did you eat when you were a poor collage student?
February 17, 2016
The main concept of the inventors in the video is valid. If we stopped raising livestock for food, many problems would be mitigated, such as clearing of forests, carbon release, and hunger generally. To reach this goal, the Not Company makes Not Milk, Not Chocolate, and Not Mayo. However, I'm Not Sure how this advances their stated goal.
These inventors are business people and they use all the current buzz words - non-GMO, carbon footprint, vegan, AI, local ... But really?
They say they have a artificial intelligence (AI) software that tells them what ingredients to mix in order to obtain the taste, nutrition, appearance, rheology, and mouth feel to copy a desired animal product food. However, this artificial intelligence must rely on data input biased by the user, and at best must rely on feedback from the users. Hmmm, "AI". It is not clear that the program actually learns from its experience.
I believe a computer program with a list of potential input materials can select a recipe mimicking the molecular formula of a desired food. But, why mimic old foods? Further, how does this save the world? They show seeds and beans (negative buzz words like soy and gluten being conspicuously absent), but for the AI to work well, the ingredients for recipes would employ, e.g., extracts or processed side materials from the seeds and beans. You do not make "milk" directly from ground up beans, but semi-purified constituents. Large bulks of side "waste" materials would result (ironically, best used as animal feed). This process of down processing and up processing would also be expensive.
An aspect (most important, as I used to be a process engineer) totally ignored in the article is PROCESS. It is pretty clear that manufacture of almost all their products will require an a combination of select process steps (extraction, separation, emulsion, extrusion, blending, Maillard reaction, baking). Many of the presented foods are puddings and cooked puddings. Many of the foods they want to mimic are not uniform in three dimensions, e.g., having different tissues running in different directions. They would need to intelligently blend intermediate products with different textures and molecular alignments to more closely mimic the intended animal product.
This all sounds fun to me. But for most products, this strategy would probably not provide close substitutes for most animal product foods at a low cost (even counting "externalities").
I couldn't find any U.S. patents on the record, maybe explaining their failure to answer direct questions about their ingredients and recipes.
Despite my skepticism, I wish them luck.
February 10, 2106
Mysterious Odd RNA Splicing Variants
The closest the article gets to explaining the technology is:
"The team developed software to generate LSV maps from RNA-seq data and combine those data with existing RNA databases to yield pictures that include ordinary, known splice variants, as well as complex splice variants that other methods fail to detect.
Would have been nice if they gave a general idea on how the software identifies complex splice variants. I assume there is a large database of common variants, and the software detects unusual sequence intersections."
The paper is said to be published at :
But, I do not see it there yet.
Anyway, with all the talk of epigenetics, and such, this data should be important to resolving some mysteries of gene expression.
February 9, 2016
FDA Approval of Wound Regeneration Matrix
As a child, I required an autograft to heal the worst of bad burns on my legs. Thankfully, I was young and had good circulation around the wounds.
In diabetes, there is often bad circulation around foot ulcers and autografts are often not feasible. Here, Integra uses a temporary silicone mesh support to present biopolymer (collagen, hyaluronic acid, chondroitin) particles to a freshly debrided wound. Keep out the germs, keep things hydrated, protect against abrasion; give it time. Hopefully, this will help some with this common problem.
See patent at:
February 8, 2016
Kill a Calorie - How is It Calculated?
I did the bomb calorimeter experiment in high school. When the dry food is burned in the oxygen atmosphere of the calorimeter chamber resultant heat warms water in a jacket surrounding the burning chamber. The rise in water temperature is directly related to the amount of calories in the food. However, the heat also includes the burning of indigestible fiber.
I have wondered for years how this error was eliminated. I would not have wanted to do the Atwater research - read on ...
February 4, 2016
Chinese Patent Court Can Be Fair, Even in Process Claim Evidence Discovery
This is an update for me on Chinese patent enforcement. There has been a difficulty in proving a case in China because there was little Discovery available, e.g., wherein a plaintiff can demand evidence from a defendant. This has been particularly problematic with regard to methods patents, where an infringer can conceal their dirty deeds in a closed factory.
Now, I see that if the method claim is to a process that produces a New product, there is an assumption that the process is likely the same as in the claim. So, where the product is new and the defendant is producing an identical product, the plaintiff need only show a valid patent and that the product is identical, before the burden of proof can be reversed, requiring the defendant to show evidence (e.g., trade secret manufacturing documents?) that they are not infringing on the process. If the defendant does not cooperate, there can be a presumption of infringement on the process claims.
The story is more difficult, but not impossible, where the product of the patented process is not a new product. If the suspected infringer is producing an old product, the plaintiff must show his own evidence of the process used to make the product. This can be difficult. However, if the plaintiff can generate enough circumstantial evidence (e.g., raw materials in, unique product properties over old process results, witnesses), the Chinese Court may reverse the burden of proof, even where the process product is an old product. The reversed burden of proof can force the defendant to disclose their process in use.
I like the words coming out to the Chinese opinions - balance interests, fairness. Sounds almost like a U.S. Court, on paper. Too bad there is not a requirement up front (with protections for trade secrets) for the defendant to disclose relevant information in the case.
February 3, 2016
Nano-Scale, Nano Useful, for Now
This article appears not to know that nanotechnology has great potential, but is not significantly developed or valuable, at this point. For example, see the list of nano-accomplishments in the 4th paragraph. Most of those commercialized examples are micro, not nano. We are not sleeping on nanofiber bed sheets, but microfiber.
What practical use have they been so far in biotechnology?
Not that there is no potential. Nano tubes have great heat and electric conductivity and amazing surface area; their tensile strength puts spiders to shame. I have discussed nano-particles in several patent applications in the field of fuel cells. But, nano is where monoclonal antibodies were in the 80's - the magic bullet that couldn't fire for thirty years.
February 1, 2016
Aptamers with Increased Binding and Increased Half Life
I guess we all saw it coming. Increased binding of aptamers using unnatural bases. Reduced aptamer sensitivity to DNases using strong hairpins.
However, antibodies against DNA are found in certain disease states (such as Lupus) and these molecules would seen to be antigenic. We shall see if such modifications avoid the stated problem of "undesirable immune response" common to antibody therapeutics.
January 28, 2016
Claim Structure May Help in Arguments Against Subject Matter Eligibility Rejections.
I have found it annoying that, in the context of a section 101 ineligible subject matter rejection, the Examiner merely waves his hands and deems the other features of the claim to be not "something more" than a natural or abstract idea. No facts, just "one of skill" would routinely do this." The Examiner should at least have to present specific references showing the other claim features are not inventive.
As the article says, neatly separating the possibly ineligible subject matter in the preamble may have some advantages. Distinctly separating the "something more" may focus the issue and facilitate structuring of arguments for inventiveness. This can help pressure the Examiner to present actual prior art references supporting obviousness (non-inventiveness) of the features in the body of the claim.
With the inventive aspect clearly distinguished, one can then point to the fact that there are no section 103 obviousness rejections, or refer to the strong arguments against obviousness provided elsewhere in the Response, as evidence Applicants are claiming something more than the abstract/natural idea.
January 27, 2016
CRISPR Interference is Not Only in Cells, But in Patent Court
University of California filed a CRISPR (Clustered Regularly-Interspaced Short Palindromic Repeats) method of use patent application about 7 months earlier, but MIT fast tracked their application and got a patent issuance after less than 1.5 years of prosecution (April 15, 2014). The CRISPR technology could enable specific insertion or mutation at a gene desired sequence position. This avoids the hazard of random insertion associated, e.g., with retrovirus gene therapy.
But who invented use of CRISPR technologies?
Since 2013, the U.S. has new rules of "first to file" for priority in a patent application. However, these applications are older and will be subject to the old (Pre-America Invents Act) "first of invent" rules. The proper patent applicant will be determined in a battle of the notebooks to determine who invented CRISPR use methods first.
The issued MIT patent (U.S. 8,697,359) can be viewed at:
The first independent claim is to methods of using guide RNA/type II Cas9 combination in a eukaryotic cell to alter gene expression. To avoid rejection for allegedly patent ineligible subject matter (e.g., natural phenomenon) the method takes place in eukaryotic cells and the guide RNA is one not normally together with the Cas 9 (a bacterial protein). The MIT patent appears to be also filed in Canada and Europe.
The University of California application U.S. 2014/0068797 is not issued :
The initial UC claims were to a DNA-targeting RNA comprising sequence that is complementary to a sequence in a target DNA, and a segment that interacts with a site-directed modifying polypeptide. Original claims have been cancelled and replaced with claims that read on the issued MIT claims, for purposes of forcing the Interference process. The UC application seems to be active in Canada, China, and Europe.
Did MIT have the invention in their notebooks 7 months before they filed? Did UC have the invention in their notebooks even sooner than that? My bet is on the earlier filer.
January 26, 2016
Bioengineering Strategies to Deal with Global Warming
This is not a bad overview of GMO benefits in light of global warming challenges.
What caught my attention was the mention of a plant anabolic pathway that greatly reduces water loss for plants growing in arid climates. The crassulacean acid metabolism (CAM) cycle allows capture of carbon dioxide at night for processing during the day, without opening stroma in the hot sun.
Some of the other technologies modify expression, perhaps without introduction of dreaded "foreign" genes.
January 25, 2016
What We Will Lose with Driverless Cars
How many of these things will you miss? How many will not really go away?
When will they make me stop driving my 45 year old Datsun 240Z?
January 19, 2016
New Next Gen Sequencing, Easy as Threading a Needle.
At first I imagined this was something like a Coulter counter, where cells going through an orifice between two electrode chambers create a resistance spike. The profile of the resistance spike allowed counting of particles and even a certain amount of characterization of each cell. I bet "they" could make a DNA sequencer that works like that. Pull the chain through a pore and monitor an electronic signal (changed resistance between sides of the graphene, capacitance change, amphometry ...).
But, this is different. They create temporary chemical bonds and rely on graphene's capability to convert the mechanical strains from breaking those bonds into measurable blips in electrical current. That is, the pores in the graphene are ringed with complementary base groups that temporarily catch their complementary base as it comes by. Stress on the graphene plane edge changes the conductivity of the graphene, allowing generation of a detectable signal.
Next, they have to figure out how to stack four graphene/pore ribbons (one for each DNA base) so the DNA strand can be pulled (did you ever try to push a chain) through four pores at once to read all four bases.
DNA reading schemes are getting more fanciful all the time.
I can think of ways to thread the DNA into the pores. Let's see. There is an array of capture probes on a solid support below the graphene ribbons. The probes have linker groups to capture a reactive group previously attached to one end of the DNA target. The probe tips wiggle around a lot at the nano scale and soon have entered the pore from the back side. Once they capture target DNA on the back side, the solid support and probe cannot retreat without pulling the target through the pore; sequenced as it passes through.
Or, how about applying a charge to the capture probe and atracting it to
the other side of the pore with the opposite charge on the other side ...?
Or, how about applying a charge to the capture probe and atracting it to the other side of the pore with the opposite charge on the other side ...?
I wonder how they really plan to thread the nano-needle.
January 15, 2016
"Cure for Cancer" May Be an Odd Phrase - How Many Cures are Patentable?
Another way to get as much (or more) money into the fight would be to at least partially reverse some of the Court decisions that make identification of disease processes ineligible subject matter for patenting. Good news is, the Federal Circuit has been a little less strict in the matter, lately.
The article said all the things I expected it to say: cancer is not one disease, there have been "wars on cancer" before, how do you define "cure", good to have more attention and funding, ...
There is hope. Gene sequencing and epigenetics have moved along identification of factors associated with the variety of different cancers. Sequencing has also helped identify patients expected to benefit (customized medicine) from a particular therapy. Monoclonal antibodies have come back in a big way (too bad it is difficult to get claims beyond specific CDRs).
Janaury 12, 2016
Negative Claim Limitations Can Give Positive Results
I use negative limitations every now and then in U.S. filings, and a little bit more in U.S. claim amendments to avoid cited art. However, some foreign jurisdictions require a positive recitation of the negative limitation in the specification (enough with the ... tion), even to support originally filed claims. Good luck getting a negative limitation amendment in Europe.
About half the time in the U.S., the Examiner pulls some rejection template out of the MPEP and says there is no support for my negative limitation. I almost always win the argument because MPEP 2173.05(i) Negative Limitations and In re Johnson allows 558 F2d 1019 say - "If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims" and the "mere absence of a positive recitation is not basis for an exclusion."
For example, if species of a claim limitation genus is listed in the original specification, or in a Markush group of a claim, individual species can be simply eliminated from the list.
My new favorite claim - 1. All microfluidic diagnostic devices, other than
those of the prior art.
My new favorite claim - 1. All microfluidic diagnostic devices, other than those of the prior art.
January 8, 2016
Another Example of the Fed Circuit Court Discomfort with SCOTUS 101 Holdings
Here is another example of the Federal Circuit Court judges feeling uncomfortable with the overly restrictive Supreme Court holdings regarding subject matter eligibility.
For example, Judge Linn concurred that the claims to amplifying and detecting cell-free fetal DNA ("cffDNA") in the plasma of pregnant women was ineligible under Mayo. However, he joined the decision "only because" he was "bound by the sweeping language of the test set out in Mayo," without which he "see[s] no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible."
January 7, 2016
Case Hints Fed Circuit May Consider Some Personalized Medicine Patent Eligible
It is old news that the species teaches the genus. Here, the genus was held to also obviously teach the species. Another interesting aspect is that the Federal Circuit Court may consider non-obvious treatments for specific patients to be non-natural and eligible subject matter for patent protection.
The article highlights that the Federal Circuit Court, in dicta, suggests that, e.g., methods of treatment may be patent eligible and non-obvious if the claims are directed to treatment of a particular subset of patients having a particular gene even if the treatment method was generally known in the prior art.
See the Decision at:
It is nice that the Fed Circuit seems to be stretching the Supreme Court holdings on eligible subject matter. This, after methods of determining treatment dosages were ineligible "natural phenomenon" in Mayo v. Prometheus, and identifying breast cancer mutations (subject to alternative treatments) were considered ineligible in Myriad.
January 6, 2016
Generous Generic Drugs Off Patent Will Fair Better in the Long Run.
Can you imagine? The worst examples of over priced drugs recently are for generic drugs, no longer enjoying patent protection. The start up administrative and manufacturing cost barriers to entry in the market are so high that a first generic manufacturer of the drug can set the price sky high. This, even though generic drug manufacturers do not have the costs and unpredictability of drug development, manufacturing, and three phase clinical studies experienced by the pioneering initial patent holder of the drug.
A major barrier to entry for a second generic manufacturer is market share. While the first into the market receives the greatest the efficiency of scale and profit margin, the second generic manufacturer into the market is a spoiler for both manufacturers.
The present system does not seem to have been a total failure. Generic drugs on average are significantly less expensive (half?) as when the patent was enforceable. Those who abuse the benefits of being the first (or only) generic manufacturer can experience the wrath of the 5th branch of government (the press, don't forget the States are the 4th), or motivate the entry of a competitor, sooner or later.
Then, there is the price of not having a patent system allowing temporary exclusive rights to pioneering discoveries. Price of a drug that would never make it to market if there were no patent system - an average of billions of dollars and thousands of lives lost or made miserable.
January 4, 2016
Another Zany Car Patent - Unicycle Spare Tire.
This can also work with zany airplanes and motorcycles.
December 22, 2015
Put Your Eligible Subject Matter Cards on the Table - Use a Defiant Claim Preamble
Mr. Hall, in the article, sets out a strategy of identifying ineligible subject matter in the claim preamble, then coming right out and saying the claimed invention is "something more". Brilliant.
Of course, it is more than a little annoying that the something more has to be laid out in the form of a section 102/103 (novelty/obviousness) argument in the 101 (subject matter) context.
This strategy lays your cards on the table, and maybe raises a red flag that section 101 should be applied to the claims. But we all know section 101 is already the darling of the year at the PTO anyway. Examiners never miss a chance to make a 101 rejection lately, often even where the claims are non-obvious and narrow to the preferred embodiment.
December 17, 2015
R&D Becoming Cost Ineffective
The twelve listed pioneering large pharmaceutical companies are now making half the return on R&D as just a few years ago; a less than 5% return. Is it worth the risk? Their declining number of new drugs are experiencing half the peak sales per product. At least the cost of terminated projects has been cut in half.
This study has been ongoing 6 years for these relatively large pharma companies. The trends are not good. Small to mid-sized pharma has been doing a little better, which is one factor in large companies gobbling up small. Small start ups are probably doing far worse.
There is hope for "increased efficiency" and such. But I do not see efficiency as reversing a trend of this magnitude. Blockbusters are not in sight. The short to mid-term savior may be in lower profit boutique (personalized medicine) drugs. I noticed Genentech licensed two recently.
In the long run, in order to motivate research, the world might have to pay more for drugs. Not likely since the non-productive nations will continue to think they should get drugs without paying their share for R&D.
See more of the study results at:
December 16, 2015
Devices "Configured To" Interact with Elements Outside the Claim
See December 13, blog at http://www.patentdocs.org/ .
Old news that a claim to a claim to a device configured to hold a camera does not require a camera to infringe. Funny, I still get rejections where the Examiner ignores the "configured to" or "adapted to" language stating that it "has no patentable weight". I guess the Examiner is misinterpreting the rule. The requirement to act with an element outside the claim may have no patentable weight, but the requirement to have a certain capability does have patentable weight. Still, I have trouble throwing it back in the Examiner's face because I can not find case law directly on point; only cases that do not question "configured to" language. Anybody?
December 15, 2015
Pig Vaccination with Wild type Virus
I guess it is a good bet to risk the healthy mother in good weather than to risk all her piglets without IgA against the virus in winter weather.
Pretty gross, though.
December 14, 2015
ATP Fueled Biomembrane Battery Powers Integrated Circuit
After reading the Science News story, I felt like I did not actually know what was going on with this electric power source. Apparently, powering an integrated circuit (IC) with biomembranes has not been done before due to a variety of voltage, impedance, and current mismatch issues.
In brief, the biopower source is a synthetic bilayer membrane between a couple of chambers and populated with Na/K ATPase powered ion channels. In the presence of ATP, the ion channels pump ions and can develop a concentration gradient of Na/k ions (electrochemical membrane potential) that can be converted into an electron flow, using Ag/AgCl electrodes. See the research article here.
Through a variety of tricks, the authors have managed to run an IC from the ATP fueled DC voltage generator. First, they prepared a stack of two membranes series with the first feeding ions to the second, in much the same way the voltages of batteries stacked in series each add to the output voltage. Then, the output voltage is fed into an integrated circuit "voltage doubler" to further enhance the voltage. Then, the voltage doubler output is fed into a switched capacitor, where electrons are accumulated e.g., for more than an hour until there is enough voltage and capacity to run the CMOS [oscillator?] load for less than 100 milliseconds. Taa daa!
Not in the news story, of interest to me, was how they convert the ion concentration differential across the membranes into electron current. I guess they took the obvious way out, in hindsight. The electrons come from the elemental silver of an Ag/Cl electrode. Of course, the silver is gradually corroded away, making the electric current somewhat expensive by the amp.
The power of the biological power source could be increased greatly by increasing the membrane loading of the ion channels and by inserting them all in the proper orientation. Apparently, the ATPase ion channel density in the power source membranes was only 5% of that found in natural nerve fibers, and much less than found in mitochondrial membranes. My wife (a neurophysiologist) reminded me that electric eels have ion channels sooo concentrated in membranes that they are almost crystallized, and the membranes are arranged in stacks of as much as 1000 membranes to have 600 volt output. Still hard to beat nature.
December 9, 2015
FDA Releases Environmental Assessment Supporting GMO Salmon Sales in U.S.
The salmon were found to be beneficial and of no environmental risk, to the U.S.
A major reason the FDA was so confident the AquAdvantage salmon would not be an environmental risk to the U.S. is that it must be raised Outside of the U.S. The FDA has no authority over what fish are grown in Panama, but assures us that it will not harm the U.S. environment to import the fish from abroad. I believe this is true, since there are several redundant safegurads that ensure the GMO salmon can not invade natural ecosystems.
The salmon are retained by layers of physical restraints, not least of which is the fact they are raised inland.
The greater guarantees against intrusion of the fish into the wild are biologic constraints. The salmon are all triploid females. This makes them all sterile and incapable of passing on their genes. Further, the same rapid metabolism that allows them to grow faster as fry and juveniles makes them uncompetitive in nature, where there is no free lunch.
Interestingly, the salmon do not grow to adults larger than wild type Atlantic salmon, but only they grow faster to that stage. The FDA has deemed they safe for U.S. import and consumption. The only problem I can see, not mentioned in the paper, is that they have three sets of genes per cell, so their meat may be less desirable to those with gout.
December 8, 2015
Prostate Cancer Testosterone Reduction Treatment May Promote Alzheimer's
Low levels of either testosterone (in men) or estrogen (in women), are associated with increased risk of Alzheimer's disease.
How is it that after 70 years of testosterone reduction treatment for prostate cancer, no relative mortality data is available? Does it have a benefit, or not? Sheesh.
Seems like the risk/benefit ratio for most prostate cancer treatments is not good. Yet, many demand treatment. Time for placebo? - with informed consent, of course.
December 7, 2015
Incorrect Inventorship - Inequity on the Patent Office and/or Standing for Inventor to Sue
The Federal Circuit Court has held that in inventor can have standing to sue for the injury of alleged incorrect inventorship listing in an issued patent.
The pretermitted (when was the last time I got to use that word?) inventor has a substantial damage to reputation providing standing as a plaintiff in court. This, even though inventorship would not give the inventor an ownership interest in the patent (e.g., due to assignment of rights to the employer).
Not mentioned in the article is the possibility of cancellation of the whole patent. That is, intentional erroneous listing of inventors can be considered inequity on the Patent Office, And, inequity on the Office can be a basis for cancellation of rights to all owners, innocent or not.
Inventorship of claims is only known when allowable claims have been identified at the end of patent prosecution. The inventors are those persons who have made an inventive contribution to any part of any issued claim. Apparently, the parties to the suit did not dispute that Dr. Shukh was an inventor.
When there is a dispute, an inventorship opinion may be necessary. The claims must be construed and the contributions of those involved reviewed. How about that ? - notebooks are still useful. However, moments of conception still often come down to the memories of the parties, e.g., what was said at a meeting.
Because inventors are often not the owners, inventorship listing is often not considered important at the time of allowance. However, this case makes it clear inventorship should be reviewed at allowance in every case.
November 30, 2015
Finger Stick Blood Samples Not Representative of Venous Blood
I was a practicing Medical Technologist for several years and collected thousands of venipuncture and finger stick blood samples. I was always suspicious of that first drop. We specifically did not use it for CBC (cell type differential counts) or anything having to do with platelets or coagulation.
In this study, they considered the large venipuncture samples the standard for accurate CBC assays. It is interesting that results apparently varied drop by drop (with no trend?) for the finger stick samples. I wonder if the same would be true for coagulation or chemistry (e.g., glucose) assays.
The part of the study I can not believe is they took at least 7 sample drops from the patient finger sticks without squeezing or "milking" the finger. Really? They must have really gouged the patient's finger with a large old fashioned lancet to get that kind of flow without any squeezing (unless the patients had coagulation issues). Then, are such samples really representative of real world finger stick samples?
November 23, 2015
Contract Manufacturing Can be "Offer to Sell" Your Drug or Device - Federal Court Reviewing Bar to Patentability
I always tell my clients "if you publish or offer to sell your invention, you have 12 months to file a patent application in the U.S. and have lost the right to file in most foreign jurisdictions." I was caught by surprise 2 years ago by a case where a Hamilton Beach arranged to have a new crockpot design manufactured in China more than 12 months before filing a patent to the crock pot. A U.S. Federal Court said the Chinese manufacturer's offer to manufacture and ship the crock pots for a price was an "offer to sell." Because Hamilton Beach did not file a patent application in the U.S. until after 12-months from the "offer to sell" the Court says the patent is invalid because it was filed too late. See: http://patentlyo.com/patent/2013/08/suppliers-offer-to-make-product-invalidates-patent-under-the-on-sale-bar.html
In the field of pharmaceuticals a similar thing has happened. See: http://www.mondaq.com/article.asp?articleid=444060&email_access=on The Medicine's Company apparently hired a contractor to manufacture a drug and failed to file a patent on the drug in less than 12 months. Thus, the patent that ultimately issued was considered invalid due to an on sale bar to eligibility.
The scenario is being reviewed in Federal Court to revisit the question of whether there should be a “supplier exception” to the on sale bar rule. See: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1469.Order.11-12-2015.1.PDF
Until then, do not fall into the trap of expecting contracting manufacture of your drug or device not to be considered a "sale" or "offer to sell" your invention.
November 19, 2015p>
GMO Salmon FDA Licensed for Production and (Ugh!) Human Consumption.
Imagine Eating a Salmon with a Growth Hormone Regulator from an "Ocean Pout" - Gross!
Those against have plenty of problems "conceivably caused". What do you think? U.S. States already in the salmon market are concerned about escape of the GMO salmon, and not about competition. Apparently, the licensed GMO salmon are intended for farming inland. They have genes that prevent fertility in the wild. If they did escape, and successfully bread, I assume the fast growing aspect would be a disadvantage in the wild. What do you suppose has the advantage, a fish thrown together with jacked up growth hormones, of a fish living in an environment where growth hormone levels ahve been optimized my nature for tens of millions of years? Still, it would not hurt to start out small scale.
I will buy the fish if it has better flavor and texture over more expensive fish. Good that it is more efficient with feed and does not have to grown in the New Zealand or Alaskan fjords. Now, if I could just get over my allergies to GMO corn.
November 13, 2015
A Shocking Way to Prevent Multi-Drug Resistant Infections on Wound Surfaces
As a child, I had burned my legs (short story - stupidity). The great fear was infection, particularly Pseudomonas. They used an antibiotic salve. It was pretty unpleasant when they tried to remove the bandages (glued on with my body fluids), but I did not get an infection.
Anyway, there were not so many antibiotic resistant bugs back then ('70s). Good they have a option for wound surfaces that does not depend on antibiotics alone.
November 12, 2015
Biotech Patenting Problems at EPO, but Filing Up
In many ways, the rules are similar to patent eligibility rules in the U.S. For example, Product by Process claims are allowed if it is the only way to describe the product. (Good luck actually getting the claims to issue.)
It seems strange that only "usual" meanings are allowed to describe cutting edge technologies at the EPO. In the U.S., the Applicant can be his own lexicographer. That is, we can make up our own terms, as long as the term does not conflict with a usual usage. We can use an unusual word. If we have a pioneering invention, we can make up our own word.
No plants or animals, no unusual words, no product by process. "No, no, no, "bad children; play nice." And yet, biotech is up in Europe. Now if we can get them to eat "Frankenfish".
November 11, 2015
Interesting Article on Next Gen Sequencing Pitfalls
What a lot of trade offs. There is a need to use plenty of controls and employ the technique best suited to your samples and goals. For example, though PCR can cause certain artifacts, it also enhances sensitivity. Some next gen sequencing (e.g., Illumina DNA colony technique) techniques inherently amplify. For others, it has been suggested that sensitivity can be enhanced with less artifacts, using a lower cycle PCR.
November 5, 2015
Can a Drug Product Insert Result in Infringement of a Patent Method Claim?
What a path to the deep and unsympathetic pockets. Let's see, the doctor is said to directly infringe the method, even though he/she never actually practiced any of the method claim steps. Then, to get big pharma's pockets, the manufacturer is said to indirectly infringe by providing a product insert with instructions on how to combine the folic acid, methylmalonic acid lowering agent (e.g., B12) followed by administering an effective amount of pemetrexed.
"Because the defendants' proposed generic drug-labeling instructs physicians to follow the patented administration, the court found they would be liable for inducing the physicians' infringement." In order to avoid suing the patient or doctor, the patent holder sued the generic drug maker based on the maker's product insert instructing another to practice the claimed method of administering the drug. Best to sue the deep pockets of evil pharma, and stay away from the bad PR of suing doctors and patients.
Actually is seems that at most that providing the product insert was at most indirect infringement (knowing end users would infringe the patented method). And the doctor may also have indirectly infringed, because she probably never actually practiced any of the method steps. Finally a nurse or the patient may have directly practiced the method (or even each contributed a step, so no one directly practiced the method).
Wow. I believe this is actually a case of inducement to induce to directly (or contributorily) infringe. Sounds like a hard case to make, but not so hard if there are deep pockets at one end of the chain.
Find the drug administration patent at:
I expect that the Court had a "gut feeling" (in equity) that the drug company was the main culprit benefiting, so went out of their way to construct a colorable theory of guilt.
November 4, 2015
Malicious Filing of Patent Application to Gain a "Monopoly" - Don't Trust This.
What I find astounding is that an eddy current braking system would be considered novel, much less non-obvious. The only new thing about the brake system on an amusement park ride, is that it was on an amusement park ride.
See the 6,062,350 patent at:
That aside, the article is annoyingly vague about the date of conception (1994), offer to sell (1995) and patent filing date (1996). I assume the Plaintiff did not have these facts, and failed to obtain them in discovery. Without, there was no case. Too bad for the Plaintiff. If Intamin, the ride designer, offered the brake system as claimed more than a year before filing the patent, the patent is invalid for lack of novelty.
This is a new one for me. Sherman Anti-Trust for alleged intentional filing of an invalid patent. Step one should have been presentation of what Intamin knew and when they knew it. See the Court case at: http://cdn.ca9.uscourts.gov/datastore/opinions/2015/09/14/13-56119.pdf
Basic lesson - don't make conclusory allegations you can not back up.
November 3, 2015
OMG Human DNA in Food Prepared by "People"
You know the Clear Food co-founder is being disingenuous from the following:
Journalist - "Wouldn’t a dish I made with my bare hands be likely to contain human DNA?
Ghorashi disagreed with my supposition that handmade food would necessarily contain human DNA and said that they were just trying to be objective."
Ghorashi knows the extremely sensitive DNA assays WOULD likely show human DNA in hand prepared food, but I believe he avoided the admission because it goes against his business model.
Too bad the article makes no effort to describe the DNA detection technologies involved. Even the Clear Labs web page seems to only refer to "third party testing".
November 2, 2015
Wither Indian Plants?
India has often railed about westerners stealing their plant medicine heritage (which Western rules for patentability (e.g., no natural compositions) do not allow). So, I expected this article to be about leafy plants. We all have our narrow perspectives on life.
I used to design and scale up GMP drug manufacturing in the U.S., so I know a think about GMP manufacturing.
I have also spent a lot of time over the years in India. Years ago, it would have been impossible to do GMP manufacturing in India at the standards required in the U.S. I suppose it is possible now. At least the utilities (e.g., electricity) are a lot more reliable now. Still, there are physical, infrastructural, and cultural challenges in India that would require very high levels of oversight in order to avoid GMP violations in India.
One can save money on labor in India, but the savings can be at least partly lost in extra efforts required to maintain quality.
October 30, 2015
Fun Article that Makes You Think About Patent/TS/TM Strategies
For many consumer products, the Silly String hypothesis is worth testing.
October 29, 2015
Using Facts to Argue Against Claim Rejections
More advice on how to get past section 101 subject matter ineligibility rejections.
I think the author is right about the Examiner's "comfort zone", but it has not been my experience that it revolves around case law.
Rejections for whatever reason (101, novelty, obviousness, ...) are all about the Examiner's comfort zone and her need to have something on the record justifying withdrawal of a rejection. If an Examiner has a gut feeling there may be obviousness, they often do not have time to dig up the facts and use logic, so they make conclusory statements and put the burden on the Applicant to present facts on the record against the rejection. Facts on the record can make the Examiner more comfortable, e.g., with presenting an allowance to their supervisor. (Funny, they do not seem to be embarrassed by their initial lame rejection.)
Another source of "comfort" in subject matter eligibility is definitely the scope of the claim. If the Examiner can get you to add a limitation focusing on your intended narrow market segment, that can lower the pressure. Narrower claims have a lower profile and this provides comfort. Claims focused on a particular device or method provide a fact pattern for allowance in alignment with the PTO Guidelines and MPEP.
I like the statement in the article that "[f]actual findings supporting arguments that the claims are to patentable subject matter should outweigh unfounded assertions that they are not." The Guidelines ( http://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf ) list factors the Examiner should weigh to determine if the balance is for or against patent eligibility. There is no bright line here. But ... where the Examiner has not provided any facts, your use of facts can "persuade" the Examiner to drop the rejection.
I do differ with the author's position that facts to Case Law makes Examiners comfortable. I find Examiners focus on the MPEP and the little snippets of case law they find there. Key words in the snippets are often twisted by the Examiner to support rejection when the case law actually holds for the opposite. It is not unusual for Applicant's facts not to persuade the Examiner over their lack of facts applied to case law. However, the fall back position is that some supervisors, and the Appeal Board members, do understand case law holdings, and application of facts.
October 28, 2015
More Details on the Google Books Case
Here is a more detailed analysis of the Google Books case.
The policy reason for copyright is ti avail the public of creative works. Most of the works searchable through Google books are out of print or forgotten. The ability to search them can bring them back to life in the public eye.
Meanwhile the snippets available from the search are not a substitute for the full work and are only available in a transformed embodiment.
Further, I assume Google is not going to make back its expenses any time soon on this adventure. We all know how altruistic Google is.
October 26, 2015
Things to Avoid When Trying to Patent Methods of Treatment
Oh, boy. Methods of treatment. So many issues.
Many countries exclude methods of treatment from patent eligibility. They believe it is unethical to restrict treatment of a patient. They probably have a point. However, this must be balanced against the lost benefits. (They don't notice the unknown patients that did not get treated because no one was motivated to invent the treatment - and no one notices something that does not happen.) However, in some of these countries, you can still claim the method of treatment using "Swiss style" claiming, e.g., the use of a substance for the manufacture of a medicament for treating disease X, even where the substance was previously known.
Then, there are the section 101 patent eligibility issues in the U.S., wherein the response of the body to the treatment may be considered a patent ineligible "natural phenomenon". How can we forget Mayo v. Prometheus ( http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf ) where monitoring the metabolites of an Unnatural drug in a patient to adjust dosage was held ineligible by the (somewhat ignorant) Supreme Court as an ineligible natural phenomenon:
Mayo claimed - A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered ...
Note the two steps. Even if the Mayo claim were valid, one (two?) could avoid infringement by having the administering step done by a first person and the determining step by another person.
The article gives good advice on how to draft method claims to include only one actor. For customized treatments, the use of a past tense step seems like a good idea. For example, treating the patient for a indication (disease) "previously determined", where it is immaterial who did the determining (identifying, assaying) step.
I like the back-up advice on using the doctrine of claim differentiation to confirm that a broad treatment claim does not require a determining step. The doctrine of claim differentiation creates a presumption that each claim of a patent has different scope. So, the article presents the great idea of including dependent claims wherein the parent genus claim "further comprises" the determining step. Logically, if the broad parent claim already included a determining step, then there would be no need for the claim "further comprising" a determining step. The presence of the dependent claim further comprising the determining step gives the Patent Attorney strong evidence against the Patent Examiner (or infringer) interpreting the broad parent claim to require a determining step. Simple!
Now, for my best advice. Do not write the claim that makes the ill patient the infringer. Let's see, don't write: "the steps of having your blood tested and receiving a treatment". You don't want to be the bad guy making the evening news for suing a sick person.
October 22, 2015
Algae Virus Invades Human Cell
My first thought is - how do these viruses cross both mammal cell membranes and algae cell walls? I suppose the mammal cells engulf them.
The Chlorella viruses are large and have many unusual properties, including ion channels and endonucelases. See, e.g., http://www.ncbi.nlm.nih.gov/pubmed/16877063 .
I will have to be careful next time I clean out my pond.
October 21, 2015
Men Demand Libido Equality!
I want a drug that improves my sense of humor.
By the way, Viagra does NOT improve a man's sexual desire. It treats erectile dysfunction. So, to be fair, and to keep men from "being left out of the [Addyi] revolution", we demand a drug that has barely any efficacy and lots of side effects too!
October 20, 2015
Good Review of Design Patent Prosecution Compared to Utility Patents
This is a good focused primer on Design patent prosecution issues and concerns.
As with Utility patents, the claims are the intellectual property. The claims must be supported by the original description and FIGURES.
The Figures must be totally accurate and use lines according to special Design patent rules.
Check out this good review.
October 19, 2015
Fed Court Holds Google Scanned Book Search Not Copyright Infringement.
Not much content here, but big news in copyright.
I believe Google is not intending to present full text (but for ancient texts) as search results. Might even help sales of books easier to identify. And should make available searches to out of print volumes.
October 18, 2015
What is New Under the Sun in Microfluidics?
The article is directed to the credibility of a diagnostic device company. This should not be an issue, because the data should tell the story, not hype, emotions, or product marketing puffery.
I snooped around a little, but didn't find much remarkable in the Theranos patent applications. Maybe they still have some unpublished applications, but breakthroughs forming the basis of a company usually come out early.
The first (Canadian) Theranos patent application I found is not issued and I believe has excessively broad scope claims, making it probably not novel.
The second application I found may have a new combination of several routine assay device elements, but would probably have a hard time arguing against the inevitable obviousness rejections.
Microfluidics is an old and crowded field. I could not readily identify some breakthrough technology (some amazing cornel of inspiration - no polymerase chain reaction here) in patents that makes would give Theranos a significant advantage in the field. They may have trade secrets, but these are hard to protect in device technologies. Does anyone know of anything special about Theranos?
In any case, validation of device parameters is routine. What are the sensitivity, precision, accuracy, repeatability, ruggedness, etc. of these assays. If they have something special, they should spit out the numbers?
"Cheaper, faster, and more efficient blood testing technology" compared to what? Let's see the comparison data - the numbers. The facts (they must have in hand) could lay to rest any controversy about how special they are. Sorry, just my process and assay validation background coming through.
October 17, 2015
What is the Magic New Model to Lower Drug Prices?
Drug pricing outliers are in the news lately. You know, the expensive (but cost effective) drug against HepC, and the no competition price rise by the young hustler CEO for the generic against parasite infestations, e.g., in AIDS patients.
The article mentions that (god forbid) pharmaceutical companies have the same profit margin as (evil) banks! I bet the data do not take into account all the small (and medium) start ups that that lose millions for years, more likely than not to go our of business, or get bought up for less than their accumulated losses. That is, the overall profit margin for all pharma (including those that never make it to a licensed product) is probably lower than for banks. And, the hope of profit (and good deeds; really) is what starts all those small drug companies that have been the main pipeline. This does not come free, and someone has to ultimately pay for this risk.
So, what is the better model, e.g., better than the extremely successful model in the free world (how many new drugs did the Soviet Union develop?) suggest by the article? They discuss the model at https://www.chathamhouse.org/publication/towards-new-global-business-model-antibiotics-delinking-revenues-sales .
To me subsidies for antibiotic development looks like a well worn model that works in certain circumstances. For example, this is similar to government subsidies for orphan drugs. Nothing wrong with that, in its place. But, it is not a general solution to high drug prices.
October 16, 2015
Satellite Patent Office Opens Today in San Jose
I hope they have Examiners in the main fields I work in. I am good on the phone, but you can not beat face to face. There are a lot of biotech and high tech inventions coming out of the Bay Area.
October 15, 2015
Surprise Me! - You Can't Avoid Infringement By Imagining Additional Limitations to the Issued Claims
Boy, this is old news. Seems to be a story of a defendant trying to make unreasonable new laws to exculpate themselves from clear guilt.
Apparently, the infringer chose to practice a less preferred embodiment of the invention (severable strip releasable along one score line instead of the preferred two).
To get out of the infringement accusation, the defendant suggested claim construction based on limiting the claim severable strip element to the preferred two score line embodiment.
Now, wait a minute! What did the claim say? See U.S. 7,118,003 - https://www.google.com/patents/US7118003?dq=7,118,003&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMIvP3uip3ByAIVVtNjCh1CZQWl
Claim 1. A tamper-resistant/evident container comprising:
a) a plastic, transparent cover portion including an outwardly extending peripheral flange;
b) a base portion including an upper peripheral edge forming at least in part an upwardly projecting bead extending substantially about the perimeter of the base portion and configured to render the outwardly extending flange of the cover portion relatively inaccessible when the container is closed; and
c) a tamper evident bridge ["scores" are not even mentioned] connecting the cover portion to the base portion.
The claim does not even touch on the aspect of score lines. Straw man argument. "I am not guilty because the claims are to red apples and my red apples also have a sticker on them. Therefore I am not infringing."
Further, "claim differentiation" requires that, e.g., if a dependent claim limits an element to one of two possible options, then the parent claim must have included additional options. Thus, the dependent claim is differentiated from the parent and of narrower scope.
Dependent Claim 4. A tamper-resistant/evident container as recited in claim 2, wherein the frangible section of the [tamper evident bridge] hinge is delimited at least in part by a pair of parallel score lines.
That is, if claim 4 further limits, claim 1, then claim 1 must include the recited parallel score lines, and at least other alternatives (e.g., a single score line) listed in the original application.
Anyway, it is old law that the claims as issued define the intellectual property. The claims properly construed reflect admissions and compromises in the prosecution history (file wrapper). However, The claims are not limited in scope to preferred aspects the infringer chooses to thrust into the claims. Otherwise we [not me, but maybe you] could all run around infringing on patents and (when caught) just say" the claims are limited to aspects I are not practicing. I win!"
October 13, 2015
What Aspects of Your Medical Device and Methods are Eligible for Patent Protection?
Here is a good example of what is patent eligible and not in a diagnostic device.
The following claim was found ineligible in Federal Court under 35 section 101 (https://www.law.cornell.edu/uscode/text/35/101) of the patent code for allegedly being merely the application of a Law of Nature using well-understood, routine, or conventional step:
Claim 51 - A method of detecting human body temperature comprising: measuring temperature of a region of skin of the forehead; and processing the measured temperature to provide a body temperature approximation based on heat flow from an internal body temperature to ambient temperature.
The claim was written in a patent application before certain Supreme Court rulings that made patent subject matter eligibility more restrictive. After that, the USPTO provided Examiners with Guidelines (http://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf ) with factors to consider in determining, e.g., whether the claim adds "something more" (inventive concept) to the ineligible natural phenomenon.
What the article does not mention is that many other method and device claims in the patent (U.S. 7,787,938 - https://www.google.com/patents/US7787938?dq=7,787,938&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMIsPSxu9m1yAIVBJeICh3IEAdP) were not held to be invalid for ineligibility. For example, see claim 14:
Claim 14 - A method of detecting human body temperature comprising making at least three radiation readings per second while moving a radiation detector to scan across a region of skin over an artery to electronically determine a body temperature approximation, distinct from skin surface temperature.
So, include specific devices and method steps in the claims (narrowing focus on your particular invention, not monopolizing the natural phenomenon) to make them patent eligible.
October 12, 2015
Apple Rivaling Tesla in E-Car Technology - Stealing Employees
I like driving my 43 year old car (240Z), shifting, and looking out the window (though I did install a moving map). And, I do like looking out the window when I drive (though I am studying instrument flight of airplanes for a certificate, so I don't have to look out the window. Hmm.)
Anyway, the iCar may be streamlined, but seems to be essentially a delivery device (See:
The special thing about humans is their ability to process information. It seems in the not too distant future, we will not be needed for that anymore. Great. Then, we can all just go dream in sensory depravation chambers like that Apple car.
October 6, 2015
You can Still Get a Nobel Prize (But Maybe Not a Patent?) for Nature-Based Medicines
Avermectin is apparently a macrocyclic lactone antiparasitic agent from a family of compounds first identified in Streptomyces sps. At first it was found to have antihelmenthic properties, bringing some aid to the hundreds of millions infested with parasitic worms in any part of the body. We in the West are more familiar with avermectin for its use in pet flea medicines due to its insecticidal properties.
Apparently avermectin has such a broad range because it blocks nerve activity in invertebrates generally. Avermectin apparently opens up glutamate channels allowing hyperpolarization by influx of chloride ions into the neurons.
A quick look for related patents finds though the avermectin may be a unique compound (modified by man?), the patents mostly concern methods of administration (to avoid rejection as ineligible natural subject matter). See, e.g.: https://www.google.com/patents/US20100087492?dq=parasite+ininventor:William+ininventor:Campbell&cl=en
October 5, 2015
Pacific Rim Trade Deal Short on Biologic Drug Protection
U.S. negotiated for 12 years exclusivity, AU and NZ wanted 5 years, deal is 3 Years?
We will see how this plays out in Congress.
October 3, 2015
Playing the Logical Song with Examiners
I often use logic (or more often illogic of a rejection) to successfully argue against rejections in claims.
It is quite common for Examiner to frame rejections in the language of logic - "since the prior art teaches this ... therefore the one of skill would be motivated to combine the references." Take these statements apart and they often are devoid of facts supporting the conclusion, or the conclusion does not follow the premise. I actually bought a collage logic text the brush up, and it has helped.
The most common error in logic of rejections is conclusory statements - "because the claims are obvious, they are obvious." I note the Examiner has presented no facts. Then, I systematically present application of facts that objectively prove the Examiner is wrong. Sometimes the facts have to be applied to the corresponding facts found in a holding of controlling case law and things can get a little more subjective.
After a good logical argument against a bad rejection, the Examiner will often just ignore the strong points and attack minor side arguments. Alternatively, the Examiner often presents a "straw man" (false premise) argument where he forcefully argues against an intentionally or ignorantly misinterpreted version of your argument against rejection. That is, arguing against a weakened of different version of the argument you presented. The best way around these continued rejections bring the error to light in an Examiner Interview and force the Examiner to present a logical counter argument (sometimes I find I was the one who was wrong!). Eventually, logical arguments can be the most successful on Appeal.
October 2, 2015
HERV-K "Virus" Escapes Human Genome and Causes ALS, Etc.
Does anyone know more about this?
The article suggests that the virus is propagating, but I suspect the "virus" is a transposon.
I imagine many archaic viruses hidden in our genome are causing any number of disease states ... and providing sequences useful in our day to day lives.
September 30, 2015
Vermont Can Tread On GMOs But Not On Nature
Vermont passed laws intended to control the use of the phrase "natural" in food products and requiring conspicuous labeling of "genetic engineered" products.
I am inclined to favor full disclosure in most cases. But, for some reason, I find the GMO product labeling rules annoying. This is probably mostly because I worked so long in the biotech industry and can not envision a mode of action for a toxicity caused by the specific modified proteins in food products. I am confident that GMO products are a net benefit and ignorant people will be hurt by the rule the labeling rules. For example, when I was growing up, we were poor. I was always excited to see a new gallon of milk in the refrigerator. It really bugs me to see a gallon of milk going for $8 because the dairy cows were not fed GMO corn. How many mommies think they are raising healthy kids, but are actually cheating them of nutrition for no material reason.
Another thing I find annoying is that certain people have their minds made up (like those arguing against global warming) that all GMOs must be bad. No amount of studies can persuade them otherwise. They just keep on the drum beat of "we need more studies" - until there is proof of a negative, e.g., that GMO corn is not going to give you cancer.
I have to believe that in the long run, GMO will win in the market. Quality products at a good price should ultimately win the day. Already GMO haters are failing to refuse the genetically modified medicines that are already saving lives every day.
Anyway, apparently Vermont can not control the use of the word "natural", mostly because they did a bad job of writing the law. What is with that uncertain phrase - all natural or "any words of similar import"? Laws that do not give clear notice to the citizens should not be enforceable. I guess there is no ambiguity in the terms "genetically engineered."
Ironic that, in patenting, some genetically engineered inventions are not considered eligible for patent protection because their DNA or protein sequences are too "natural"!
September 28, 2015
Layered Defense to Prevent Infection of Implant Surfaces
It looks like these films on the prosthetic surfaces don't last forever, but long enough for a convalescence.
For example, a hip replacement outer surface can have a non-antigenic polymer, then a antibacterial peptide, followed by our old friend nano-silver. Follow that with a an extremely fine polish to remove opportunities for microbes to loiter.
Maybe, then, antibiotics could be held in reserve.
September 27, 2015
Investigations into Permanent Contraceptive Device
When the alleged complications present as such a diverse array, it is likely that many of them are not actually caused by the medical device, though one or more may.
They should take complaints seriously and look into any possible problems. If there is actually a problem caused in some women, how would you identify it against the background? If they are lucky, they might find a clear cut case and at least have a model and mechanism to identify countra indications.
September 26, 2015
Experts Review the Effects of Patent Eligibility Restrictions on Inventions in Biology
Experts agree these are relatively difficult times for diagnostics, software, and biomolecule patents.
Patent eligibility (35 § 101) depends on factors, such as whether there is a physical device involved in the claimed invention, a physical transformation, and/or a narrow focus (thus not monopolizing a natural phenomenon).
It is often easier to avoid these eligibility issues with carefully crafted claims and supporting application. See factors weighing in favor of eligibility in the current Patent Office Guidelines - http://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf . The problems are more difficult with patent applications drafted before the new restrictions of recent Supreme Court holdings.
These new restrictions will reduce innovation in medical diagnostics, analyses, and medical devices. Hopefully, the pendulum will swing back a little when the politicians realize the current policies are counter productive.
September 25, 2015
Tiffany Trademark Not Generic Just Because Tiffany Style Setting is Generic to Jewelers
Jewelers know a Tiffany setting as a generic type of setting. However, the term is probably not generic within the buying public, as a whole.
Costco may have done better if they had called it a "Tiffany style setting", to minimize confusion.
September 24, 2015
Patent Law Damages a Good Basis for Reasonable RAND Rate
However, Fed 9th Circuit still requires totality of circumstances approach to determining reasonable and nondiscriminatory (RAND) rates in agreements and damages for pooled use of standard essential patents.
September 21, 2015
Male/Female Fetal Risk Varies Through the Trimesters (and Beyond)
I always figured there was a bias toward males at conception, e.g., to make up for the higher male mortality during infancy (and beyond).
Here they have identified several phases of gestation where the greater risk of prepartum death alternates between male and female.
September 18, 2015
Happy Birthday to You - Again.
Here is a little more information on the dramatic story of the Happy Birthday song.
It would be nice if it were to finally enter the public domain. I can hardly take it when the staff at a restaurant has to come up with some alternate rousing Birthday song when they give away a birthday muffin with a candle in it to someone who "says" it is his birthday.
Still, the original Happy Birthday to You is not free of its own problems. If only people could hit the high note.
September 16, 2015
Miraculous High Tech Medical Devices Reduce Malaria Deaths 60%
What Can I say?
I wonder how many of the billion mosquito nets were paid for by Bill Gates?
September 15, 2015
New Perspectives from Hallucinogen Treat Opiate Addiction
The new perspectives of a hallucinogenic Ibogaine plant extracts can reset the priorities in life for opioid drug addicts.
Besides the mental attitude change, an unexplained (and unrelated?) phenomenon is the drug actually limits physical withdrawal symptoms.
Hmmm. Both these benefits from one drug. Maybe the extracts are complex and there are several plant compounds providing the multiple effects.
September 14, 2015
Unproven Concepts in Public FDA Licensing Documents Do Not Render Drugs/Devices Unpatentable
This is good news for bio/device companies trying to FDA license and patent their inventions.
It appears that in order to manufacture a patented drug, a potential infringer filed a challenge (IPR - inter partes review) at the U.S. Patent Office alleging that the claimed drug was not new. The basis of the challenge was that a preliminary generic study and Phase II proposal allegedly published the invention (dimethyl fumarate for use against MS), rendering the method not novel (and not patentable). The actual results of FDA studies were not published before filing of the patent application.
It is nice that the Patent Review Board (PTAB) found that the publicly available information cited by the challenger did not actually anticipate the claimed invention. This is a little more generous than many patent Examiners who would have deemed the invention as "obvious to try" in light of the suggestions in the cited publications. Of course, the argument against such an obviousness rejection would be that "obvious to try" requires facts showing that at the time of the invention, there had been a recognized problem or need in the art with a finite number of identified, predictable potential solutions. See, MPEP 2143. Although MS was known as a problem and maybe suggested as a possible treatment, use of DMF in treatment was not predictably efficacious. Anyway, the PTAB is generally less biased toward rejection than the average Patent Examiner.
Another reason the PTAB held the claims to be novel is probably political. Think how many past and future licensed drugs and devices could be deemed unpatentable for lack of novelty if preliminary proposals (a wish and hope), e.g., in public licensing submissions, were deemed to anticipate inventions not yet confirmed by reduction to practice. For these policy reasons, this case may be going against the general situation that actual physical reduction to practice is not required to support a claim in a patent application or in a cited reference to render the claim old or obvious. That's one less blow against the protection of intellectual property in the drug and device industries.
September 11, 2015
Patent Fun - Stacked Wings on Aerocars (Idea Stolen From Red Baron)
They left more out than just the propulsion configuration. The aerocar might obtain adequate lift, with at least 5 operating wings, but there would be a lot of drag and so much vertical stabilization that it might be hard to turn. Most aircraft rely on ailerons out at the wing tips with a lot of leverage to turn the craft by rolling. Here there is no leverage and a lot of forces working against roll. So much turbulence behind the wings that that elevators and rudder would not work. Seems all you get is lift and no control. (Sorry about my private pilot cynicism.)
Still, this design does address the most perplexing problem with flying cars - how to reduce their width after they land.
Maybe this could be used by Amazon as a way to deliver cars.
Try, if blocked:
Try, if blocked:http://blog.caranddriver.com/toyota-two-inventors-file-patent-for-aerocar-with-dynamic-stackable-wing-system/
September 9, 2015
Enhanced PK in Deuterated Drugs
The bonds deuterium forms with carbon atoms are stronger than those formed between carbon and normal hydrogen. Who knew? Apparently this was well known since the '70s. So, for some drugs with pharmacokinetics heavily influenced by degradation at the bond, PK can be improved by deuterating key H-C bonds. I guess this may help in 15% of cases. This shouldn't cause an activity problem except, e.g., the unusual case where activity depends on proton donation.
Here is another example of where maturation of a technology will eventually render similar products obvious and unpatentable. Like the stereo isomers example.
In another aspect, it is sorry that donation of an idea to the public domain (e.g., expiration of a patent) actually leads to disuse of the idea because a successful new application of the idea can not be monopolized. I know ... maybe I should patent tritiated drugs?
September 8, 2015
No Need to "Defang" CRISPR for Use in Specific Gene Regulation
Here is a finding that mere use of a shortened guide RNA can allow Cas9 to bind a specific target sequence but prevent the cleavage.
Apparently, cas9 can be fused to a controllable protein to turn a target gene off and on (not sure how the Cas9/coltroller structures interact for this function). Anyway, a cool new aspect of the ability of the CRISPR/Cas systems to target specific sequences in living eukaryotic cells.
September 7, 2015
In Europe, Can a Priority Application Anticipate a Claim, While the Same Priority Application Can Not Support Filing of the Same Claim?
No wonder I have had trouble clarifying the issues of novelty over parent applications, partial priority(?), and toxic divisionals in Europe (EPO). Apparently, the Europeans still have not figured it out themselves.
I will have to ask my EP Attorney about this OR wait for the 2016 decision in the discussed case.
Am I missing something here, or "isn't it ironic?" that the EPO will NOT find support for claims in a parent priority document for a filed or amended claim, yet finds the same parent document IS toxic prior art over the divisional? Hmmm, the parent does not describe the claims, yet renders them not new.
Isn't the EPO over the top in finding novelty destruction in the context of claim rejections, while the same support is inadequate in the context of claim amendments during prosecution? I am not an EPO attorney; just trying to understand the logic or politics for these EPO policies.
September 3, 2015
Problem with Implanted Artery Clot Filters
I have worked on a few stents, but I have never even heard of this device. Do they permanently implant them in 45 year old women? Coated titanium, I guess?
Gosh. If a clot can push a filter clear into the heart wouldn't there have been a catastrophic myocardial infarction in any case?
Game theory. At what point do you recall a device on hearing of problems? Don't all devices have some problems?
September 1, 2015
"Means" Language Makes a Computer Algorithm Inventive and Patent Eligible
The method is an algorithm, but the Court was unwilling to go to that 101 issue for failure of IPR challenger's conclusory arguments. The 101 subject matter eligibility analysis continued to step 2 where the general purpose computer issue was reviewed.
Ultimately, the means plus function claim element generated, in effect, a “special purpose computer” providing a meaningful limitation on the claimed abstract idea. The key aspect saving eligibility here appears to have been the "means plus function" language. Hmmm. The narrow means may have rendered the invention patent eligible because it was considered inventive (non-obvious in light of cited art).
Warning: Now I Am Being Kind Of Funny (too many readers take me serious at all times) - From now on, I am going to use means plus function claims. How about, "a special purpose nucleic acid means" adapted to hybridize to a natural sequence correlated to a disease state."?
August 31, 2015
Nano-Technology Still Seems to Have Nono-Utility in Medical Devices
Many nano-device concepts seem a little unrealistic, like the predictions of the future at the 1939 World's Fair. Several seem to describe nano-scale structures in the wrong context. For example, descriptions of nano-scale devices as if there were gravity and frictional interactions, which often diminish to irrelevance as nano-scales are approached.
The only place we seem to have a realistic and short term promise for nano-technology in medical devices is fibers and fabrics. And here, their structures do seem to function in ways similar to analogous macro-fibers and biomolecules, e.g., transmitting tension forces along a line.
Factories, robots, welders, and walkers. I guess nanotechnology is so new we have to use macro-scale terminology to help describe imagined analogous phenomena.
If the promise of nanotechnology seems a little over stretched for now, it also seems the dangers are a bit overblown, given current information. As noted in the article, we can only hope the promises will be fulfilled without irrational fears that have nearly stifled GMO technologies in some circumstances.
August 30, 2015
Don't Cite "Probably" Prior Art.
Next time I get a flaky "prior art reference" from a the Patent Office in a section 102/103 rejection, I am going to demand the Examiner provide evidence that the material was published specifically to "those in the art" and demand an exact publication day (e.g., for web references or nucleic acid sequences).
Oh yeah, do not use © (circa/about) for a critical reference citation in an adversarial proceeding.
August 25, 2015
You Don't Have to Be a Glutton to Like Gluten
My favorite bread flour is "high gluten" flour. You get a nice crispy tasty crust.
I know several people who actually have a severe problem with the real gluten sensitivity of celiac disease. We have special recipes for baked goods we bring when visiting them.
Still, there has been some hysterical anti-gluten media reports that have caused a reverse placebo effect in society. It is crazy. Do you want your bananas and fish to be gluten free? Then, we can sell you some, for a slight premium.
It is easy to place blame in error for an illness (just look at the whole vaccine debacle). Whatever you were doing at the time of the symptom must be the cause (hind sight, anecdotal evidence).
I remember I was eating Chex Mix as a child when I came down with the measles. For about 10 years I could not eat Chex Mix (or even look at it); even though Chex Mix did not cause my measles. Imagine how such errors can be catalyzed by relentless negative media accusations (and marketing promotions).
August 24, 2015
Apple Screen Surface Design Patent Invalid for Obviousness
These Apple design patents have been annoying me for years. Design patents are supposed to protect an Ornamental Non-Functional aspect of a product. It was crazy that Samsung had to pay Apple hundreds of millions of dollars over the highly functional aspect of "rounded corners" (do you want sharp corners in your pocket phone?) design patent. See: http://www.google.com/patents/USD670286?dq=D670,286&hl=en&sa=X&ei=zgWdUNGqIIHo0QGsz4HQDQ&sqi=2&pjf=1&ved=0CDQQ6AEwAA
Now, at least one of the three Apple design patents has been invalidated; not for claiming a functional aspect (which the screen face topography is substantially) but for obviousness based on prior art references. I suggest the prior art references had similar screen face layouts because of convergent evolution based on efficient Function. See screen layour design patent at: https://www.google.com/patents/USD618677?dq=D618,677&hl=en&sa=X&ved=0CB4Q6AEwAGoVChMIh-D1g9y_xwIVAzGICh3Kig9r
Why does the PTAB not invalidate design patents based on claimed features being functional?
August 23, 2015
Dimmable Control of mRNA Expression (and Some Cool New Acronyms)
Nice to see Los Alamos National Laboratory is keeping their information systems busy in biology.
I haven't read the actual ACS article, but it appears that the cis-repressor RNA (crRNA) binds to the ribosomal binding sequence to block transcription of the targeted mRNA. Since the ribosomal binding sequence is not unique to each mRNA, I assume the crRNA binding sequence also includes a short set of bases complementary (not complimentary - I learned that lesson) to the early peptide encoding sequence of the mRNA.
Then, a trans-activator RNA (taRNA) must have sequences capable of competing for the crRNA, thus removing the crRNA from the target mRNA at some rate (variable to have the fine "dimmer switch" extent).
Not having read the article, I wonder if I am right. If they are doing it a different way, maybe I should write a patent application within the next 12 months.
See: a Figure accompanying the Abstract at: http://pubs.acs.org/doi/abs/10.1021/acssynbio.5b00041
August 21, 2015
Patent Term Adjustment From Slow PTO Review Not Added to Later Sister Applications
This is only reasonable because the Applicant could have pursued sister applications in parallel (have you ever done this?). At least the Terminal Disclaimer is not going to hurt.
August 20, 2015
Treating Generic Primary Malignancies, Custom Mutants, and Mixed Mode Cancers
The faulty genes associated with dedifferentiation and uncontrolled cell division must only number in the low hundreds (right?). Can't we develop a therapy (miRNA, small molecule, antibody ...) individually for most of them? There must be a lot of common mutations treatable across a variety of malignancies. Even now, we are seeing effective uses of drugs for non-approved conditions. Not a bad back up position, if the primary cancer type therapies fail.
Soon, more drugs and biologics will be licensed on mutation indications (customized treatments) instead of based on generic primary carcinoma indications.
Then, there are the cancers expressing combinations of various mutations. Maybe we can mix up a combination of therapeutics. Bartender, bring me a cocktail.
August 18, 2015
What Analgesic Works Best?
They say acetaminophen does not work well, then show
data that it works almost as well as ibuprofen.
Aspirin works pretty well for me. Usually I get relief (mild headache) with only one 350 mg tablet. I never started on the other analgesics after the first time I saw their chemical structures. Aspirin looks nicer.
August 14, 2015
Prophecy is the Solution to All 102, 103, and 112 Rejections.
Who knew an imaginary experiment in an examples section could deliver so much ammunition against both written description and enablement rejections. And, they didn't even have to offer up an expert Declaration or post-filing data.
I use Inherency arguments all the time against novelty rejections:
Ex parte Levy, (17 USPQ2d 1461, 1464) which states that "[i]n relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Just because an Examiner's reference could describe the claim doesn't mean it anticipates, unless all embodiments of the prior art meets the claim.
Here, inherency comes again to the rescue, but this time in the context of section 112 rejections. In Alergan v. Sandoz (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1275.Opinion.7-31-2015.1.PDF), glaucoma eye drops were held non-obvious, described, and enabled based on the promise in the applicationthat the formulation will work better than a standard old formulation.
Written Description was adequate because the Applicants had possession of a formulation that in fact was apparently better than the standard. The Applicant said it would work in the imaginary experiment of Example 5, but never actually showed any data.
The claim was enabled because the claimed composition could readily be prepared and Example 5 said it should work to reduce intraocular pressure more than the standard treatment. A patent does not need to guarantee that the invention works for a claim to be enabled.
Great. I am going to add imaginary Examples to alll my applications from now on. Say the composition functions, and you can avoid novelty, obviousness, written description and enablement rejections based on a functional (wherein clause) element of the claim. Now, how to get around that pesky section 101 subject matter rejection.
I wonder how well this would work in China.
August 13, 2015
Proposed Reduction in Corporate Taxes on Profits Associated with U.S. Innovation
Considering the U.S. has the second Highest Corporate Income Tax in the whole World, it would be nice if the tax was reduced. What better way to reward research and marketing of novel ideas?
Too bad the initial proposal includes a complex (and subject to abuse?) formula. Hmmm, the tax break is based on "qualified gross receipts derived from the sale, lease or license of qualified IP", subtracting the expenses and deductions attributable to qualified gross receipts, and multiplying by the ratio of domestic research and development expenses to all expenses over the past five years to provide a reduced income for taxation. Might cost me as much for my tax guy to figure as I would save in taxes. Could be a big benefit to evil large corporations, though.
Anything to reduce corporate taxes in the U.S. and motivate innovation. Even President Obama admits Corporate taxes are tooo high.
August 12, 2015
Another Hypersonic Jet Patent that Will Never Be Infringed
First, the TIME article shows the author's failure to understand either aviation or patents. I guess Airbus "won" a patent which was approved for a one-year term".
The aircraft seems a bit me-too with three thrust sources (turbojet, ram jet, and rocket). Seems to have issued because it has a weird combination of the three engines, the ram withdrawn into the fuselage and the rocket behind a door; running on hydrogen, with a delta wing ...
Still, fun to dream.
See patent U.S. 9.079,661 at : http://time.com/3982901/airbus-patent-supersonic-jet/
August 11, 2015
Antibiotic Resistance and Transfer of Resistance Readily Accomplished, Even Though Multiple Mutations Required
I am not sure what are the "strategies" in the article title to outsmart the pathogen - be more sparing in antibiotic use?
Things are happening in the antibiotic resistance experiment, but I am not sure why after reading the article. The culture of E. faecalis is exposed to tigecycline resulting in increased copy number and transfer of conjugative transposon (Tn916), originally a tetracyclene resistance factor. Isn't this just bare bones selection? Bacteria not upping tetM expression and transferring resistance in conjugation are at a selective disadvantage in the population of the culture.
It was interesting that the tetM (blocking tetracyclene) over expression is capable of blocking the related tigecycline. Apparently through a similar (competitive) interaction for a ribosomal binding site, but requiring higher tetM concentrations to be effective against tigecycline.
See Abstract at - http://mbe.oxfordjournals.org/content/early/2015/06/24/molbev.msv133
August 10, 2015
Conjugated MenC Vaccine is Difficult to $cale Up
The last project I worked on at Chiron as a Process Engineer (before I got my first Patent Attorney job) was the conjugated MenC vaccine. I heard it got licensed and saved the lives of a few collage students and military service recruits.
Too bad the vaccine is so expensive and difficult to scale up; particularly, in a developing country. I do recall that the process of manufacturing the vaccine was particularly difficult, hazardous, and expensive.
Seems the product must be off patent by now (never was patented in Nigeria). This should be one time low cost manufacturing (in India) may be appropriate.
August 8, 2015
EPO Productivity Up - Another Tale of Low Hanging Fruit
The turn over of EPO patent application files has increased substantially recently. How about that 33% increase in grants!
However, just like many statistics in life, you can't expect them to continue on forever. Wherever extra efforts are made in a damaged environment result in more improvement than the same efforts in an already healthy environment. Look at the recent growth in China, or improvements in some bad schools compared to successful schools.
I just hope some of the cherry picked patents for grant are some of mine that have languished at the EPO for years.
August 7, 2015
Not all U.S. Utility Patent Applications Publish at 18 Months
It is so routine in my office to file a provisional and go on to utility that I was surprised to see that most applications do not publish 6 months after the U.S. utility filing date.
Still, the publication dates are 18 month, just 18 from what. I remember a few years ago that cases often did not publish on the 18 month date because the USPTO seemed to get behind and publish at 19 or 20 months.
August 6, 2015
3D Printing of Pills - What Shape the Layers?
Pills in the photo look pretty plain. They should have made them shaped like hollow teddy bears.
Applying binding liquid to powder layers to eventually form a pill. This may be new to pills, but is old in other areas. I wonder how many licenses Aprecia needed to practice and what is the advantage over simpler candy coating technologies.
See a patent here: https://www.google.com/patents/US20140065194?dq=8888480
August 5, 2015
Again, Stopping Indian Medicine Pirates.
It is not piracy to apply for a patent. If your idea is not new, the patent will not issue.
Of course ancient treatments are not patentable. However, new methods of treatment, new processes of preparing compositions, extracts that have never been prepared, and new combinations of old compositions should be patentable.
Imagine the color of a man's head after hair loss treatment with turmeric!
August 4, 2015
Mitochondria and MS
It is possible that this work eyeing mitochondria is closer to the root of the MS problem than simple autoimmunity.
The problem with many diseases without pathogens (bacteria, fungus, virus) is that they are complex with any number of system degradation results easily mistaken for causes. What came first in MS, myelin sheath degradation, mitochondrial damage, or autoimmunity? Causation, correlation, coincidence. At least politics are not involved.
Boy, have mitochondria been in the news a lot lately.
August 3, 2015
Lame Rejections - Not a Work at Home Problem, but Lack of Effective Supervisory Authority.
Just yesterday I was reviewing two Office Actions for my clients. Each was a final Office Action that failed to address key arguments of my prior Response.
In one case, there was never ANY discussion of rejected dependent claim 6 on the record. This is because the cited prior art did not teach the claim. Instead of allowing claim 6, the Examiner just ignored it, even after being challenged to state a case in the first Response. It appears the Examiner wanted to get the case off her desk and it was too much work to process an allowance past her Supervisors.
In the other case, claims were rejected in a conclusory fashion without application of any FACTS. In fact, the facts show that the suggested combination of prior art elements would change the principle of operation in the primary reference and render it inoperable. Rather that find new references, or present a fact based argument (too much work), I get these conclusory rejections.
I am not saying the Examiner's are overstating their time, but are probably reacting to perverse motivations in the Patent Office system (under the protection of their Union and/or embarrassed Management, since Supervisors seem powerless?).
Anyway, I routinely go over the head of such Examiners with Request for PreAppeal Review (RPAR) and Appeal Briefs. And I almost always (eventually) win the Decision.
Maybe the PTO should have a policy of weighing Appeal Decisions against Examiners. Maybe we should all Appeal more often. Usually, I don't have to wait too long (though last week I did win a 3-year-old Appeal Decision) because I win the RPAR, or the Examiner does not want to put a childish Appeal Answer on the record.
P.S. I have arranged to Interview these with the Examiner and her
SPE, which can ofter avoid steps to Appeal.
P.S. I have arranged to Interview these with the Examiner and her SPE, which can ofter avoid steps to Appeal.
[Finally found something of interest to write about after returning from a family funeral in Australia.]
July 27, 2015
Malaria Vaccine Prevents Only One in Three Cases, but Also Avoids 6 New Cases for Every Child Vaccinated.
The benefit of the vaccine (plus combined preventive measures) is greater in reducing spread epidemiology than at preventing cases in particular individuals. This is the bigger story.
And, they have only spent $300 million on it so far. See the GSK release at:
July 24, 2015
Long Disrespect for Unmet Needs - Obviousness
You think long felt need is a waste of time in litigation, try this argument in prosecution with an Examiner.
Too bad. Long felt unmet need is strong evidence of non-obviousness. If it was obvious to make this improvement, why did thousands of people with this problem for many years not come to this solution?
July 23, 2015
European Unitary Patent Fees May Be Down Drastically
A few months ago the suggested fees for a Unitary European Patent covering all EPO contracting states was stratospheric. No one would have used the Unitary scheme. I was sure the EPO committees would ever drop the fees enough to make validation in all EPO countries attractive. Yet, here I see they may have found a formula that can work for some patentees, the EPO, and European national patent offices.
The renewal fees for total European protection may be set at about the level as if the patentee had validated in the top 4 most commonly validated nations. The article makes much of the fact that election of a Unitary patent would only save a few Euros over the 5 to 10 year renewal period. But the real bonuses are much lower fees through the 10 to 20 year renewal periods AND the fact that the patent is enforceable throughout the 38(?) contracting states. All this for the price of 4 countries.
I am also surprised that the numbers represent a 5 year break even for the EPO (no big EPO profits, in contrast to the initial proposal), and the small rarely validated countries appear to have backed down on requiring the unitary patent to be a monetary windfall for them.
July 5, 2015
No Xenophobia for Engineered Transplants
First with the standard comments against xenotransplants - no swine for jewish patients (or is this actually not against the rule?). Inhuma[i]n[e] Hmmm.
I remember when I was studying blood banking, as a Med Tech intern. I was surprised at the large number (beyond ABO/Rh) of antigens known to cause adverse reactions in whole blood cell recipients. In transplants, the number is even higher (far beyond MAJOR histocampatibility - MHC antigens). I can not imagine how many genes would have to be modified in a pig lung to reduce the host versus transplant rejection to an acceptable level. Still, I suppose it is manageable, in the long run.
July 4, 2015
Are Antibiotics Causing Our Obesity Epidemic?
More on the influence of the microbiome on a person's health at all stages of life. Attack a single species pathogen with antibiotics, and, wooops, you also wipe out a hundred other useful species. The unintentional side effect is loss of protective commensal organisms, as has been well known for decades.
Now, we see that these organisms, intimately associated with our immune systems and processing of nutrients (have you ever seen how many lymphocytes there are in all layers of the GI tract?), have a strong influence on the shape of our bodies. That is, the undesirable balance of microbiome species after antibiotics can promote in obesity, and later diabetes and high blood pressure. See:
Thank god I was too poor to go to the doctor when I was a kid. Amazing that modern pampered kids go through a course of antibiotics at least once a year (probably for viral infections). This has got to stop.
July 2, 2015
What Defines Chinese Bioethics?
Apparently there is some international peer pressure on Chinese researchers not to use CRISPR to modify germ lines.
I am curious. What is the basis of Chinese ethics? The article raises Confucianism. How well has it survived communism, the cultural revolution, and the rise of capitalism? Anybody?
July 1, 2015
Plastic Surgeons Must Consider Client Culture in Breast Implant Surgery
What can I say. Apparently desired breast shape, size, and appearance varies north to south and young to old.
June 30, 2015
How Y. Pestis Became a Pest
I am not sure how acquisition of an entire new gene can be considered "single small genetic change" in Y. pestis. The article does not mention that Pla exhibits a plasminogen (Plg) activator activity (PAA) that promotes the cleavage of Plg to the active serine-protease form called plasmin. This probably makes the pest less subject to certain passive immunity cascades.
June 29, 2015
If 85% of Patents are Invalid, Why Hasn't the Market Responded?
The value of patents has always been clouded by compounded assumption errors. The average value of patents has never been accurate to within 25% [I just made this up; like everyone else does]. And, the value of specific patents is always biased by the dreams of the owners.
OK. 85% of the inter partes reviews have gone against patent holders. This is low hanging fruit and will taper off. This surge of invalidations was just a big wave flowing past because the AIA had lowered the transaction cost to dispute validity. The wave also surging due to certain recent Supreme Court holdings and dicta.
I suppose one reason that the "grief process" has gone straight from denial to acceptance is that there had really been no denial. The dirty little secret may have been that the weakness of many patents was rumored and already priced into the market.
June 25, 2015
Relative Patent Numbers Show Electronics Over Mechanics in Cars
Just another data set that shows cars are becoming rolling computers.
I can't complain too loudly. I just finished putting a computer programmable multi-spark ignition controller in one of my 42 year old Datsun 240Zs and found I am getting 10% (!) more gas mileage. Though, the first controller I put in was unreliable. And, I have a backup wiring set in the glove compartment to take the controller out of the circuit, if if ever goes bad on the road.
Maybe not surprising that the 100 year old engine patent category was not near the top in numbers of patents.
June 23, 2015
One of Skill Can See Structure and Scope, Even in a Software Claim.
The abundant functional and result oriented language in software claims has often made me cringe. However one of skill in the high tech arts knows the options, and specific structural language is often not required in this field.
Here, in Williamson v. Citrix, ( http://patentlyo.com/media/2014/12/13-1130.Opinion.11-3-2014.1.pdf ), a "graphical display" limitation was deemed to have relatively broad scope by the Federal Circuit, and a "module" limitation had enough structure to avoid being deemed a means plus function limitation.
The infringers were claiming non infringement due to narrow construction of the graphical display, and invalidity for alleged lack of an embodiment in the specification for a means plus function limitation. The Federal Circuit disagreed on both counts.
The claims required graphical display representative of a classroom. The infringers wanted to limit this to only the exemplary display of the figures. The Court found no suggestion on the record that Williamson intended or one of skill would have so limited the term.
The infringers wanted the "module" term to be interpreted as a "means" (for alleged lack of structure of the term in the claim) so that they could trigger indefiniteness invalidation for lack of description in the specification. They even went so far as to argue the point citing an unpublished case. However, a module is a structure, and the whole phrase "a module for providing a first graphical display" offers even more structure to one of skill. So the Court held it to be more than a means limitation.
In the end, the "district court erred: (1) in failing to appreciate that the word 'module' has a number of dictionary meanings with structural connotations; (2) in placing undue emphasis on the word 'module' separate and apart from the claimed expression 'distributed learning control module'; and (3) in failing to give proper weight to the surrounding context of the rest of the claim language and the supporting text of the specification in reaching the conclusion that the drafter employed means plus-function claiming."
To put a cherry on top, the Court awarded costs to Williamson. Makes me feel a little more comfortable drafting software applications an claims, even in light of recent negative holdings.
June 17, 2015
PTAB Patent Eligibility "Threshold" Not Always Higher Than Novelty/Obviousness - First 6 Months
It does not seem logical. Having a threshold step more stringent than the following steps is a faulty process. The article mentions a case where the claims are considered routine and conventional (35 section 101) even though they are not obvious (35 section 130). How can something you wouldn't think of be routine?
The article does mention several instances where one Guideline factor (e.g., lack of preemption in the field, or the presence of a simple device) provided eligibility, even where other factors were not in favor. However, PTAB decisions are non-precedential. A lowly Examiner will no way take the risk of allowing subject matter by giving significant weight to one factor alone. In fact, if a claim is weak on one point of the weighted subject matter eligibility factors (see - http://www.uspto.gov/sites/default/files/patents/law/exam/bilski_guidance_27jul2010.pdf) , the Examiner will often focus on that weak point and dismiss favorable factors.
Still, it is good news that a case can get through section 101 if there is a limited scope (no preemption, means claims) further limited by a machine and/or transformation. Software, business methods, and apps out there - focus on your business plan embodiments and make it do something physical.
At least the first 6 months of PTAB decisions give me some hope. If you are willing to appeal (and I am), and have a lot of TIME to await an Appeal Decision of the PTAB, you might receive an allowance of your claims having the dreaded natural or logical aspect.
June 15, 2015
Thanks for the Natural Phenomenon, Now Go Away! Fed Circ Invalidates Fetal NA Detection Method
Sequenom has finally lost in the Federal Circuit. Validity of generic claims to detecting paternal nucleic acid sequences of fetal origin in maternal blood are held to be invalid. The presence of the fetal nucleic acid is a natural phenomenon.
The good news for Sequenom is the priority date for the US6258540 patent is 1997. See https://www.google.com/patents/US6258540?dq=6,258,540&hl=en&sa=X&ved=0CB4Q6AEwAGoVChMIma_A_fuMxgIVBqWICh3oYwk7 . I hope they got a lot of good years out of their ineligible invention before the rules changed with Mayo in the Supreme Court.
There is a lot of focus on the generic independent claims in the Court's discussion. See Claim 1:
1. A method for detecting a
paternally inherited nucleic acid of fetal origin performed on a maternal serum
or plasma sample from a pregnant female, which method comprises
I wonder if things might have gone differently had an independent claim been narrow to the intended market embodiment. The Court (see - http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1139.Opinion.6-10-2015.1.PDF ) said the absence of complete preemption does not demonstrate patent eligibility, but the weight of the preemption factor could have been minimized with narrower claims. Focus on the "best mode" or intended market product may well have enhanced other factors, such as providing a diagnostic device or physical transformation of the sample.
June 12, 2015
Who Owns CRISPR IP? - Notebooks, Filing Dates, Publication Dates, Fast Track
I imagine the disclosures of the earlier UC Berkeley and MIT patent applications do not totally overlap. Under the controlling old first-to-invent rules the intellectual property of CRISPR may be divided depending on what they have in their specifications and notebooks.
The whole thing could have been simplified for UCB if they had requested early publication. I have a similar situation with one client (less dramatic subject matter) and I will be watching how events turn.
June 11, 2015
Review of Rules Impacting Protection of Life Science Inventions
This article is a pretty good review of issues around protection of biologic products.
Having been in the biopharma industry for more than 30 years, I find it amusing that the article refers to life sciences patents as an "emerging area". Actually, there was a boom in the '80s and a lull in the '90s. Small molecules screened from arrays have not met their promise yet. However, the genome projects, improvements in MABs, and miRNA applications have boosted biologic patenting.
Not mentioned in the article was forces against the emergence of biologic intellectual property. Yes, there must be a use for the nucleic acid sequence, after the Court ruling that single nucleotide polymorphisms (SNPs) do not have utility, in themselves. But, further, the sequence can not be a natural sequence (cDNA qualifies for having introns unnaturally removed).
The "trend" in biologics and medical device businesses has been alliances and acquisitions for some time (how old is the author?). More often than not, research does not go as desired or expected. Often research leads down interesting paths not in the corporate business plan. It is far more predictable and inexpensive to buy a smaller company what has proven technology that fits the plan. (I remember my brother spent $20k fixing up a Corvette that someone else eventually bought for $11k.)
A real trend may be the combination of devices and biologics. It is becoming more and more common for medical devices and prosthetics to have a biologic component, e.g., to generate a signal, deliver an activity, or enhance functions of devices.
In order to qualify for patent protection, it is best if the invention is different from natural materials in some way, does not monopolize a natural phenomenon, and is in combination with other unique structures non-obviously solve a defined problem. See, e.g., http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products.pdf and http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf
June 9, 2015
Alice was Less a Mutant than Funk and Flook
The article does not seem to make total sense. Yes, the Funk Brothers and Flook decisions were judicial error ("mutant"), but it does not follow from the facts that Alice is also a mutant.
I believe the Supreme Court (SCOTUS) was incorrect in the precedential Funk brothers case (https://www.law.cornell.edu/supremecourt/text/333/127 ) holding that a novel combination of nitrogen fixing bacteria, working in inventive ways was not subject matter for patenting. Section 101 provides that new compositions of matter are patent eligible. It is routinely acknowledged that all inventions are combinations of natural things. The Funk composition was a new combination of Rhizobium, e.g., in association with certain legumes. At least seeds inoculated with the new combination should have been considered eligible for patenting.
In Flook the claims were directed to updating alarm limits during catalytic conversion method in a device. The claimed method was identical to prior art systems except for the use of a mathematical algorithm to precisely control timing of a process point in an old old method stepno hardware. (See, https://supreme.justia.com/cases/federal/us/437/584/ ). The inventive aspect was essentially the algorithm.
I do not see how these cases bestow a mutation onto Alice. It may have been a mistake to deem Funk and Flook as patent ineligible, because they at least had some elements of compositions or systems. Meanwhile, Alice, though a method, seems to be simply a mental data manipulation adapted for increased speed and efficiency with the obvious computer implementation. Even then, the independent claim did not even bother to cite a computer.
For me, the annoying part is much talk of "inventive concept" in these cases. Sounds like the European Inventive Step or U.S. obviousness analysis. Throughout all these cases it seems the SCOTUS analysis starts with evaluation of whether the claim is solely to a natural phenomenon or algorithm, then moves on to an analysis evaluating obvious of the combination (which would have been better reviewed under the more clear rules of section 103 obviousness analysis).
Back to Alice ( http://www.supremecourt.gov/opinions/13pdf/13-298_7lh8.pdf ): the claims at issue were directed to an the abstract idea of intermediated financial settlements. Under “the longstanding rule that ‘[a]n idea of itself is not patentable.’" Quoting Mayo "an element or combination of elements [must be] sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.” However, there was no machine or transformation of anything physical in Alice, with only information flow carried out in existing computers long in use. Alice may have been a non-mutant ruling.
See Bilski Guidelines for weight to be given factors in determining elegibility of software methods: http://www.uspto.gov/sites/default/files/patents/law/exam/bilski_guidance_27jul2010.pdf
June 8, 2015
Multi-GMO Potato Fights Rust, Bruises, Worms, Cancer, and Fighter Jets.
Yes, but wouldn't such a Multi-GMO potato come up out of the ground and knock down buildings in Tokyo, while being fired upon by fighter jets?
June 6, 2015
Brains Have Lymph Flow Through Dura Mater (Exciting!)
So strange. I had just asked my neurophysiologist wife about brain lymph (interstitial fluids) a couple of weeks ago and she wasn't sure where brain lymph flows, but into the cerebro-spinal fluid (CSF). We had been talking about the recent papers on how the space between brain cells expands to clear waste while we sleep (see, http://www.nih.gov/news/health/oct2013/ninds-17.htm). (Interesting dinner conversations we have.)
I knew there had to be some way the brain handled interstitial fluid flows besides just dumping them into the CSF.
June 5, 2015
The Magic Bullets Against Cancer are Information and Immunotheraphy
I was at Cetus/Chiron when we licensed Proleukin (IL-2). It seemed to help some with melanoma, and for some orphan indications. There was experimentation with treating patient T-cells in vitro with the cancer cells to expand the killer T-cells specific to the tumor. Helped a percent, and made another percent not feel good.
The article dances around it, but gene sequencing and bioinformatics should be the key to identifying those who would benefit from certain "magic bullet" treatments, and those who will not.
June 4, 2015
How Long to Train a Good IP Judge - Chinese Judges Leaving Bench
The Chinese justice system will never retain the best until the Judicial System is a Co-Equal to the Communist Party
June 3, 2015
Print My Organ in Living Color
A common thread with most 3D printing is there is a single media, e.g., a plastic polymer or metal. Printing 3D organs should not be all that difficult in the long run once the stream of media can be intermittently changed to provide the variety of different materials required in a tissue or organ. This could be accomplished with a serial or parallel ejection of, e.g., minerals, polymers, fibroblasts, glandular cells, endothelial cells, to print a picture of a tissue cross section (maybe based on photographs of actual tissue cross sections).
It might not be that far away for simple tissues. And, there should not be too much politics against this, as long as the cell source is the patient's own body.
June 2, 2015
Using CRISPR to Attack Nosocomial Infections
When I first saw this article title, I thought there would be a lot of problems in using phages to fight a toxemia. For example, rapid clearance, limited bacterial genus targeting, patient immune response. The irony of attacking the bacteria with their own "immune memory" system did not escape me.
In reading the article, I see they intend a more practical use. The idea of targeting nosocomial infections by killing bacterial in hospital surfaces is a good one. This, particularly since the phages are configured to provide a selective pressure against bacteria having antibiotic resistance.
June 1, 2015
Latest Humanized Bispecific Antibody Links Killer T to Target Lukemia Cells
The bispecific antibody has a T-cell specific (CD3) arm and an arm against CD20 (common in certain leukemias).
Genentech expects it may have a complementary action with the current Rituximab (anti-CD20) monoclonal. Although the two antibodies appear to target the same antigen on leukemia cells, Genentech expects that competition won't be an issue, and the bispecific antibody can help recruit additional T-cells to attack the opsonized leukemia target.
The “knobs-into-holes” technology (http://www.ncbi.nlm.nih.gov/pubmed/8844834) to minimize homodimer contaminants is apparently old news, but a fun way to favor heterodymers during bispecific antibody production.
May 29, 2015
Most Important Invention - Device to Test Antibiotic Sensitivity
Rapid determination of antibiotic resistance is one of the most important technologies on the planet. The old Kerby-Bauer assay using antibiotic disks on a lawn of the bacteria took a couple of days, but at least also gave a quantitative level of sensitivity. However, the result was often too late because the patient was already being treated. And, the doctors never ordered the test because is was slow and expensive.
Contrary to the comments in the article, I do not believe the resazurin is metabolized (directly) by the bacteria, but undergoes a redox reaction due to the presence of metabolizing bacteria in the nanochamber confines.
It should not be hard to develop a means to provide the antibiotics in an array, and in a range of concentrations for identification and quantification of resistance.
I have been amazed at how long it has been taking to develop a good practical test for bacterial antibiotic sensitivity. These inventions could save thousands of lives every year AND slow the progress of antibiotic resistance evolution.
May 28, 2015
Filing early AND often is the good rule.
If you file early, you may not have the best details and variety of species, and best mode. But, first-to-file forces this hand. To cure the defects of early filing, you must diligently further develop the invention and file a follow-on provisional application whenever you have substantial new material. By the end of the 12-month provisional period, you should have a strong position against competitors (unless they have been filing during the 18-month period before publication of their application!).
More good news is that filing additional provisional applications is not expensive (particularly for small and micro-entities). Just throw your new examples onto the end of the previous application and make some adjustments to the general text referring to the new material.
May 27, 2015
Adjusting Car Computer Software Said to Infringe Copyright, and Risk Death
If I buy a book and cross out a sentence and replace it with one I like better, I am not violating copyright law. This is what happens with a car's software is changed, e.g., to modify the rpm at which the transmission shifts.
The article seems naive. Perhaps the copyright issue arises when a third party sells a whole new set of software code wherein a part is changed, and the rest remains as in the original code. The third party has copied the "creative" original work.
The annoying part are disingenuous arguments about safety when the real motivation is to keep control of the dealer's high margin service.
Reminds me of the old days when the car makers each had different on board diagnostics (OBD) standards, again, so they could control service and repair of cars they manufactured. Was a time a machine to read the computer data for a car cost thousands of dollars and worked only one make. Even the independent auto mechanics couldn't afford the capital expense of buying all the OBD readers for all the makes. After Congress interfered (law requiring a uniform OBD standard), now I can read the OBD on all cars with a $35 blutooth adaptor talking to my smart phone.
I still do all my own car mechanics, even on new model cars. Computers are not an issue on my 1972 240Z. http://www.biopatent.com/cars.html
May 26, 2015
Software Claimed as a Device Must have the Structural Means
Device claims were invalidated as ineligible software subject matter for allegedly not including any of the four patentable subject matter types of processes, machines, manufactures, and compositions of matter. I am not sure why the patentee admitted that the claim elements are all software elements.
Invalidated claim 60 was to, e.g., a data input means, output means, audio playback means. Wouldn't the audio playback means include speaker systems? Means plus function claims are limited to those examples in the specification, and ... examples of audio playback means included, e.g., D-A converters and audio speakers. There were exemplary hardware means too for the input and output means. See patent specification at: https://www.google.com/patents/WO2001031634A1?cl=en&dq=5,799,273&hl=en&sa=X&ei=hQRhVdPXI8y2oQSqiIDoDA&ved=0CCwQ6AEwAg
Claims were rejected based on the statement that “[s]oftware may be patent eligible, but when a claim is not directed towards a process, the subject matter must exist in tangible form. Here, the disputed claims merely claim software instructions without any hardware limitations.”
Lesson one, I guess, is not to have the claim novel software as a device, e.g., without uniquely interacting hardware. In any case, one should not place all their bets on software claims with solely functional limitations (means limitations not listed in the specification), even if the claims are process claims.
When the preamble characterizes the claim as a device, the claim drafter better put up or shut up. I guess software claims may do better in the form of a process. Still, it kind of gets on my nerves when I read software patents and see so much talk of means and results without specific examples. I guess the expectation is that one of skill in the art would know how to mash together code to practice the invention without undue experimentation. However, it is looking more and more like this kind of specification writing and claims are not going to fly anymore.
Worse yet, as here, it appeared there was hardware and examples of "means" yet the Court gave it no weight. See case at:
May 25, 2015
Innocence of Muslims Copyright Takedown Reversed
The movie may be distasteful, but the take down had so many flaws it is amazing the CA Federal Court granted the injunction and take down.
It is unworkable that each actor in a movie would have a copyright interest. "I was the bearded extra in the crowd waving a flag in Gone with the Wind. Stop showing it because I am no longer comfortable with my performance."
Ms. Garcia seems to have been genuinely mislead by the movie producers. However, she did not herself fix an integrated work. It is old law that she did not have a copyright.
The worst mistake of the CA Fed Ct was the unconscionable prior restraint on political speech (the content of which they probably did not agree with). Not in America. Here, we have a right to say things that make us look mean or stupid. Then, others can judge our stupidity (unless someone interferes).
May 24, 2015
Patents Can Issue to Correlations of a Natural Sequence to a Disease State
Well, we have here an example of claims issued in a patent for a correlation of a natural nucleic acid sequence to a disease state.
The independent claims are methods requiring, e.g., obtaining a sample of a skin lesion ... detecting the presence of a nucleic acid molecule expressed from C6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218, and ... comparing the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample to the presence of C6orf218 in a non-melanoma sample.
Well, you can not practice these claims in your head. But this looks like the natural sequences rejected in Myriad and the correlation of natural substances to disease states rejected in Mayo. Still the allowance. Why?
The claims incorporate steps that amount to significantly more than the natural principles themselves because the steps do not merely incorporate conventional, routine techniques while failing to incorporate some other inventive concept. Was this case issued without a section 101 subject matter rejection because the claims were not obvious?
The claims are more than the natural phenomenon, and go out of their way to not monopolize the natural sequence. The claims are greatly narrowed by the limitation that detection be by labeled probes. The claims do not monopolize the natural nucleic acid.
The history of the patent prosecution shows that the Examiner agreed that "detecting melanoma in a human subject" or "diagnosing melanoma in a subject," by "detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample," is not taught, alone or in combination, by the art cited in the Action. I believe this is inappropriate analysis of claim obviousness (35 section 103) in a section 101 rejection, but I am starting to get used to it. The key here seems to be that, compared to some rejections, the Examiner does not unreasonably start with the assumption that the natural principle is known. (Although many Examiners believe the Patent Office Guidelines require analysis based on a construct as if the natural phenomenon were previously published.) Anyway, it does help if the analyte detected in the assay was not previously known or if the analyte was known but not associated previously with the disease state.
So, an allowance can be had where the analyte was not known and the inventors graciously limited detection to what they intend to practice in the market place (even if one could obviously engineer around the claims by detecting the nucleic acid without a labeled probe).
If DermTech starts making any money on this, we will see if 1) the claims hold up under the scrutiny of post grant review at the Patent and Trademark Appeal Board (PTAB), and/or 2) someone else sets up an assay quantitating the C6orf218 without using a labeled probe.
May 22, 2015
I Want a Copyright on my Patent ... and a Patent on My Copyright
I had always been under the impression that text and images of a patent application were in the public domain. Maybe, defacto, since no one ever files a suit alleging copyright infringement of patent content.
May 21, 2015
Design Your Patent to Take Total Infringer Profits
The case seems unfair to Samsung. Just because the PTO let issue an improper Design patent claims to functional elements, Samsung is stuck with huge damages, mostly not associated with the infringement. The Court even admits, in the context of trade dress, that the claimed design is functional:
"Here, all factors weighed in favor of the trade dresses being functional and thus unprotectable under trademark law."
See the case at: http://patentlyo.com/media/2015/05/Apple-v-Samsung.pdf
Yet in the context of the design patent ... “Samsung contends that rectangular form and rounded corners are among such elements that should be ignored in the infringement analysis.” Id. But, the court held, the precedent cited by Samsung did not support a rule “to eliminate elements from the claim scope of a valid patent in analyzing infringement.”
That is, even though the design is acknowledged as functional (Design patents are supposed to protect only the ornamental, non-functional, aspects of a product), the Court hands were tied because the functional elements (e.g., rounded corners) were in the scope of the issued patent, which is presumed valid.
Here is a great place to offer Inter Partes Review (available to Utility patent infringers, but not Design, I believe).
Then, damages were killer. 35 U.S.C. § 289 - whoever sells or exposes for sale any article of manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit, but not less than $250. Because the Samsung phone had rounded corners, they have to disgorge all profits on the phones sold.
I am going to recommend Design patents to my clients more often.
May 20, 2015
Do We Need A CRISPR Human Gene Pool?
Ironically "they missed the target a fair amount of time and hit a lot of other targets." Isn't the powerful thing about CRISPR that it is highly specifically directed?
May 19, 2015
Trans-Pacific IP Protection vs Generic Drug Availability
Considering their constituency, I suppose the amfAR positions are rational for them. Weaker IP protection for U.S. inventions around the Pacific would probably not reduce innovation in the U.S. much, but provide more generic drugs in the foreign (less inventive) countries. Essentially, a transfer of information wealth from the U.S. would benefit a number of people around the Pacific.
amfAR suggests they "fully recognizes the important role that IP plays in incentivizing investment in lifesaving medicines, the precise levels of protection necessary to adequately support this research and development are highly debatable."
See more at:
And, actual amfAR Brief at:
Still, some of their statements seem naive or to intentionally misstate facts to justify their political position. For example, they state it is unfair for infringers to have to show invalidity of a patent. amfAR suggests the proposed Trans Pacific Partnership (TTP) agreement would "reverse the burden of responsibility so that patent challengers would have to prove a patent’s invalidity rather than the patent owner". I assume this poorly constructed statement meant to say the old rule required the patent owner to prove patent validity before they could accuse an infringer. Well, the actual old rule has long held that a patent is presumed valid (because it has been granted after review by a patent office). So, the TPP restatement of the rule is not a reversal of the burden; and, in fact the burden demanded has been met, to first show validity. It should not be considered unreasonable for an infringer to then show invalidity of a patent, if they choose this as a defense to an infringement accusation.
Next, amfAR goes into the usual mischaracterization of "improvement" patents as some way for "multinational corporations" (code words for bad guys) to unfairly extend the terms of their patents. amfAR says:
“[T]he TPP requires that countries provide patent protection to any new uses or methods of using a known product.” Such provisions have been used to continually extend periods of patentability through a practice known as “evergreening" ...to prevent generic production."
First, please note that almost all inventions are "improvements" over prior technology, and this is recognized in the definition of what is patent eligible subject matter the world over (see, e.g., U.S. 35§101). If the improvement is new and not obvious over the old drug, it is patent eligible. If it is an obvious improvement (e.g., "minor changes are made to existing patented drugs in order to justify a new patent"), the "improvement" would not be issued in a patent. If the improvement is new and non-obvious, it is a contribution worthy of a reward of patent.
Second, even if the improvement is patentable, it in fact (literally) does not "prevent generic production". The generic drug, as originally licensed with expensive clinical trials by the mean old multinational corporation, can be practiced as generic drug with support from those clinical trials. The original patent is expired and a gift to the public domain for all to practice. It is untrue that protecting patentable improvements "would allow the re-patenting of older drugs with minor modifications." The improvement can not be practiced 1) because it is patented, and 2) there may not yet be clinical trial data on the improved drug.
So, amfAR is probably right that more lives may be made longer and more comfortable if the levels of protection are not increased for patented drugs. However, they could be less political by not mischaracterizing the facts, and maybe by saying thanks to those who have spent their lives inventing life-saving drugs. What drugs has amfAR developed?
May 18, 2015
European Unitary Patent Fees Still Do Not Add Up
Wow, maybe we in the U.S. should start charging renewal fees Every Year and get rich, like the Europeans! Humor aside, the price is way tooo high, even for my bigger clients.
What is not mentioned in the article is the politics within the EU on the topic of patent fees. As with the monetary union, there those who generate the most income, and those that want a windfall by "sharing". In order to satisfy all the 30, or so, members, they would have to either demand even larger fees (killing the unitary concept) or requiring one country (Germany?) to subsidize the others.
May 16, 2015
Preamble Limitations Can Not Save Claim Body in Subject Matter Rejection
There is a general rule that limitations of a preamble must be considered, e.g., if necessary to complete the structure of the claim. The Examiner's often ignore this rule in 102/103 rejections. When they do, instead of arguing, I simply amend the preamble limitation into the claim body.
See, e.g., MPEP 111.02 Effect of Preamble - “If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim.” Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999).
Here, it seems the rule is even less respected in the context of section 101 eligible subject matter rejections. Still, the bigger problem may have been the failure to connect the claim body better with the preamble limitations, e.g., by reciting interacting structural elements or physical interactions.
May 15, 2015
New Rules for Reporting Nanoparticle Production
There are many exemptions, including wherein use is for R&D or medical devices.
May 14, 2015
Not the Patent Rolls, Dir. Kappos, but the Trolls
I think the main premise of the article is misplaced. I have not seen so much anti-patent as anti-"troll" hysteria. And the problem there is not the patents so much as the Federal Court system configured to allow victory to those most able to win a battle of attrition.
May 12, 2015
Virtual Software Does Not an Allowable Patent Make
I do most of my patent drafting in medical technology and mechanics (although I do have staff who do work software). I have to describe how structures interact to provide a desired functional result. From this perspective, I have been somewhat disturbed in reading software patents when I see purely functional language. Seems it was the style in software inventions for quite a while.
Of course, it is not necessary to write in your specification what is commonly known in the art. See, e.g., In re Myers, 161 USPQ 668, 671 (CCPA 1969). However, if this can stand in for your claim function, maybe your invention is not new (or at least obvious).
Seems all the software patent drafters needed to do was to provide a block flow diagram of the software algorithm and some text describing alternates for each step of the process. One should be able to patent an invention involving software, but the data is the work piece and the inventor should be able to describe how the data is manipulated to provide a desired result.
May 11, 2015
America Invents Act - Solutions and Remaining Problems
Funny thing, of the seven changes brought by AIA, there is no mention of first-to-file.
Anyway, I think AIA has been a good thing, by enhancing patent quality. I get a little nervous though, after the quality initiative of Director Dudas, wherein Examiners were terrified to issue even a good patent for fear of losing their jobs. Big focus was on preventing "false positive" allowances, and no consideration was given to the huge loss given to inventors receiving false negative rejections.
Yes, the whole patent assertion thing had gotten out of hand. The main value of the portfolios (of the PAEs and giant corporations too) was the fear of Federal Court lawsuit(s) costs, not the value to the IP. OK, we are addressing the assertion of invalid patents, e.g., with inter partes review. It is great that AIA has provided a much cheaper and faster route to resolving patent validity issues.
However, a major issue still being ignored (in patents and all litigation) is the unethical use of expensive Federal Courts in battles of attrition, where evil doers force innocent parties to accept injustice. Loser pays may help this a little, but will not solve the abuse of the Court system.
May 9, 2015
Measles Infection Causes Immune Suppression - Vaccine Avoids
Geez. And I thought I was strengthened by my childhood measles. What does not kill you does not necessarily make you stronger.
May 8, 2015
SCOTUS May Affirm Obviousness of Solving a Problem Not Found in the Prior Art
After KSR (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2006)) first came out, everyone thought it would destroy our ability to argue against obviousness (103 rejections) based on combinations of references. Before KSR, there was more weight given to the fact that two references were in different fields of technology. More importantly, pre-KSR one could argue against obviousness by pointing out that there was no express "suggestion" in the cited prior art to actually make the combination of elements describing the claim.
Well, my allowance success rate actually went up because KSR also strengthened the concept that it is not obvious to take an element from a secondary reference and incorporate it into a primary reference in a way that requires it to function differently. After KSR there also seemed to be more respect for the argument that it is not obvious to incorporate an element that would require the primary reference to change its principle of operation. So, KSR was not the disaster we had expected.
KSR also reiterated that "obviousness" depends on whether evidence shows that persons of ordinary skill in the art had a "reason to combine" earlier technologies into the claimed invention, such as to address a "known problem."
Now I see that Federal Circuit case SCIENTIFIC PLASTIC PRODUCTS, INC., v. BIOTAGE AB ( http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1219.Opinion.9-5-2014.1.PDF ) will go before the Supreme Court. Here the "obvious" combination solved an unstated problem, but the problem was found to be subjectively "implicit".
The facts show that the invalidated patent protected certain low pressure chromatography cartridges with an easy open cap sealed with complementary inclined sealing surfaces to prevent leakage. The primary reference used an o-ring seal and the secondary reference presented a soda bottle cap seal with complementary inclined sealing surfaces.
OK, I have a gut feeling that it would have been obvious to combine the inclined seals with the primary reference cartridge. However, this may be another example of a bad facts making bad law. From my point of view, adding the inclined surface seal would change the principle of operation (o-ring) in the primary reference. More to the point, the only place a problem is identified concerning the need to seal the low pressure cartridge is in the patent specification itself. The Court finds it obvious to solve a problem that can not be found in the prior art, but only in the patentee's specification.
For me, this could be a big problem. If an Examiner can just say he has a gut feeling that the problem was implicit, that "guts" the problem solving requirement of KSR. What would we have left? In light of recent SCOTUS decisions, I have little hope Scientific Plastics will be overturned. I just hope the Justices do not throw in a holding (dicta is usually enough for an Examiner) that further supports hindsight identification of the problem solved by reference to the patentee's specification.
If Scientific Plastics is affirmed, let's hope it is ultimately no more a disaster than KSR was.
May 7, 2015
One Way to Get More Value Out of Your Mayweather Fight Ticket
Boy, this journalist really does not like boxing. But he has a point that filming a boxing match is not copyright infringement.
May 6, 2015
Vermont - The Non-GMO Mouse That Roared
In the long run this may be a good thing for GMOs. There is so much erroneous bad press on GMOs that maybe it is time for people to find out that GMOs have always been everywhere and done no harm. And, to find out it will cost more for lower quality food if they decline GMO.
May 5, 2015
Design Patents - Ornamental and Non-Functional?
The article fails to mention clearly that design patents protect the ornamental, non-functional, aspects of the object. For example, the attractive contours or relief designs on a pump handle. This should not cover the functional aspect of the handle, e.g., structure ergonomically presenting the hand grip.
Maybe the lapse is intentional. There have been cases where functional aspects were protected by Courts that seem to misunderstand the limitations of design patents. I was blown away by the victory of Apple in protecting a cell phone shape of a rectangle with rounded corners. Rectangles are a standard functional shape for packaging (oh, yeah, design patent subject matter has to be NEW) device components, and must have rounded edges for toughness and to avoid tearing at people and pockets. Do you want a smart phone with sharp edges?
See the iPad design. Note the grey or dotted aspects are not protected - only the solid lines.
Anyway, I have noticed an increased interest in design patents lately. In many cases, you can get a lot of bang for the buck.
May 4, 2015
More on Biosimilarity and the Patent Cliff
"Biosimilarity" is the biologic drug counterpart for "Equivalency" in the generic drug field.
Of the three hurdles to marketing biosimilar drugs (regulatory exclusivity periods, regulatory proof of biosimilarity, and patent exclusivity periods) the most difficult seems to be the patent exclusivity aspects. Biosimilar manufactures can meet the FDA regulatory hurdles, but often try to get a head start in the race to the market and become entangled in tit-for-tat patent actions.
As a patent approaches the end of enforcement, the biosimilar makers can choose to correspond and cooperate with the original manufacturer (though the Courts have confirmed this is not a requirement). We are not seeing this optional up front communication between original and biosimilar manufacturers.
Meanwhile original manufacturers monitor regulatory filings to see if the new biosimilar manufacturers are trying to develop data for regulatory approval, so they can sue early.
To counter, the biosimilars file IPRs (interpartes review) cases at the PTAB (patent and trademark appeal board) alleging the patents are not valid.
To counter, the original maker may also assert their improvement patents (e.g., dosage methods, improved formulations, manufacturing) which were filed later and have later expiration dates.
Such a cat and mouse game. At least "pay to delay" is out the window for generic drugs and is expected to apply to biosimilars, as well. See Federal Trade Commission at:
April 29, 2015
You Turn Me Inside Out - Flipping Algae Gastrulas
In the process of embryo formation, a morula of cells becomes a hollow blastula sphere. The sphere evaginates to become a cup-shaped gastrula, and eventually the gastrula everts to flatten out as a three layered (exoderm/mesoderm/endoderm) structure.
This article and film show how an algae accomplishes the tasks of evagination and eversion solely by changing the shapes of the cells.
Although study of algae may provide clues, it is suggested mammalian embryology is more complex, e.g., requiring more complex molecular, intracellular and extracellular interactions over a much longer period of time.
April 28, 2015
Toyota Out Front Again with Fuel Cell Cars
Toyota was the one that made hybrids acceptable in America. They can probably do it again with hydrogen.
Too bad the article is short on technology. Is the hydrogen stored in a solid matrix or as a pressurized gas in a canister? What are the details of the preferred technology for separating hydrogen from methane?
April 27, 2015
Patent Classes Flat Lining - Are We Running Out of Pioneering Inventions?
I have heard it many times, so it must be true - at the turn of the 20th century the Director of Patent Office suggested the Office be closed because there was nothing left to invent. All the inventions were merely combinations of old stuff. All the industrial machines were just the same old iron levers and wheels.
This article suggests that we are again running out of pioneering classes of inventions, or at least that issued patents are weighing more heavily toward combinations of old elements. Is this because we are less adventurous? ... more lazy? ... or in a universe with a limited number of fundamentals?
Maybe there are a finite number of fundamental technologies and once they are used up all new patents will be combinations from old classes. This is not contradicted by the continued log growth of patent numbers while the number of invention classes has flat lined. We have discovered light, and gravity, and smelting, and N-P junctions. How much more is there out there that we have not detected with our technologically amplified senses?
What other explanations are there be for the growth in new patent classes falling behind the growth of patents issued? Patenting outside of marketability might be a factor. Whereas patents used to focus on monopolizing a market, many patents are now pursued to impress investors with quantity, or to stuff a Scientist resume. There is also a large group of first time inventors excited about patents (e.g., due to shows like Shark Tank) and thinking they have something in a combination, e.g., paint brush/can opener/flashlight.
Still, it's not over 'til it's over, and it will never be over. The article mentions biotechnology. Look at some recent new classes - several totally different gene sequencing technologies, CRISPR, miRNAs, epigenetics ...
See the actual article at:
April 26, 2015
When Will Robots Draft Patent Applications?
I thought the article was going to be about software that drafted patent applications. There are computers that write novels, and such, you know. Maybe a computer could even draft a crude application based on a presented outline, and an Attorney could smooth out the rough edges. But, it will be a long time before a computer can actually draft an application, much less proper claims.
Alas. The software merely simplifies formatting and numbering tasks. Claims and paragraph numbering, section formatting, insertion of literal claim support.
I wouldn't exactly call this "automating the patent application process" but the software could save some time with original and updated application drafts.
Over the years my law group has developed our own version of formatting and numbering tools using Word features, such as styles, document merging, and macros. Still, if you don't want to develop these features, it might be nice to buy them premade. Probably better than my system. Not sure what it costs.
See brief "demo" at:
April 24, 2015
Are Malaria Vaccine Final Data Disappointing?
The article makes it sound like the vaccine was a disappointment. However, the vaccine works across all forms of malaria; that is amazing. Serious adverse events are reduced more than 30%.
Some of the odd information in the article includes that even with boosters the incidence of malaria in vaccinated children did not go down as they got older. Still, one would think lives would be saved because the greatest losses occur in the youngest children.
Odd too that the incidence of meningitis was much higher in vaccinated versus control children.
Missing data includes incidence of mortality. Did this save lives?
See Lancet publication at:
April 22, 2015
Inventively Missing a Prior Art Reference
It seems strange from the viewpoint of a U.S. practitioner that any consideration is given, when evaluating novelty or obviousness, to how hard it would have been for one of skill in the art to have found a prior art reference.
See the lines 75 to 79 discussion of the case at: http://www.austlii.edu.au/au/cases/cth/APO/2015/14.html
To be relevant to inventive step (in Australia) a cited prior art document must be one that the relevantly skilled person would have ascertained (among other things). I guess they consider a patent document not readily ascertained in a routine search less damning (less obvious).
I remember a case hurt late in prosecution because neither we, nor the Examiner, were using the right search terms. Everyone was searching "eye glasses". Much later, someone thought to search "spectacles" and found a reference devastating to our claims. I guess in Australia, the claims may still have been considered inventive because we had trouble finding the reference.
Novelty is a matter of fact. Either the invention was previously documented or not. The same should be true for Inventive Step (obviousness) analysis. GIVEN the prior art that exists, would it be obvious to use of combine as in the claim. Is it inventive to miss prior art reference in a routine search?
April 21, 2015
Even With Money EPO Examiners Not Happy
I had always thought the quality, succinctness, and cooperation of EPO examiners was above the rest. However, I had also noticed lately a little less cooperation and less reasonableness. Maybe they are getting crotchety, even if well paid. Sounds like a management problem.
April 20, 2015
Ford 11-Speed Tranny
Got to love planetary gears, but this is over the top. After 10 gears isn't that really a CVT?
See patent app at:
April 19, 2015
BHT. Another Magic Bitter Pill
When you starve or over exercise, blood glucose can go low, glycogen sources can be depleted. With the body running mostly off of fat, many ketones and organic acids result in the metabolism of fatty acids. Ketoacidosis results.
Still, the brain can continue to run on certain ketones, such as β-hydroxybutyrate (BHT).
Apparently there is a whole system, I never heard of, called the inflammasomes. sounds like a vesicle, but they are protein complexes assembled in a variety of different ways, e.g., depending on the source of irritation (virus, nucleic acids, asbestos, TNF). Geez, I do not have time to memorize all the acronyms:
Anyway, the article below says BHT interferes with inflammasomes (e.g., reducing Alzheimer's - is this why exercise is the best way to prevent congantive impairment?).
AND, BHT can help one lose weight, not just being a product of losing weight.
April 16, 2015
PTO Does Not Know (and Doesn't Want to Know?) When Examiners are Doing Bad Work
We don't want to go back to the bad old days when all Examiners were afraid to allow a patent, for fear the review panel would find an error in their work (with no such review for non-allowances).
The article touches on the weak hand of supervisors, but drops the ball. I have run across maybe three really incompetent or lazy Examiners in my career, apparently intentionally obstructing prosecution of cases. They were so outrageous in their rejections that I had to go over their head to their SPE (supervisor). Each time, the SPE agreed with my comments about the errors in the Examiner's work. What really struck me though was the SPE seemed afraid to confront the Examiner with the facts for their bad work. I always wondered why. Does anyone know? Anyway, I would go further over the SPE's head to a QC Specialist, and usually got some productive action (although in two cases the Examiner was not reassigned, hated me, and continued obstructionist behaviors).
I see three big chances for the PTO to improve Examiner performance. 1) Stop rewarding volume and rejections. 2) Give SPEs a freer hand in disciplining Examiners (are these guys Unionized?). 3) Do a thorough prosecution history review of cases where the Examiner loses an Appeal or Decision in a Request for PreAppeal Review.
I have received comments from an anonymous previous Examiner suggesting that the SPEs are not innocent and that SPEs intentionally turn a blind eye to lame rejections. Some even "demand new examiners reject all claims in every application no matter how 'bogus' the rejection is."
What is the motive for this? Less work? It is easy to reject all claims, especially on the first Office Action. No one reviews this. Allowances are more visible.
Sometimes there is a reasonable rejection of independent claim, but the dependent claims appear allowable in light of prior art on the record. Maybe, the SPE and Examiner are too lazy to search further and make the additional arguments, but have a "gut feeling" the dependent claims shouldn't be allowable either. Patent prosecution is complex, and it can be difficult to do all the searches and make all the arguments on a tight time line (PTO quota system).
In a completely opposite strategy, I have seen Examiners throw in every possible rejection (valid or not) including all rejection rationales. 30 page Office Actions, in a battle of attrition hoping to discourage the Applicant into abandoning the case; while the Examiner gets credits for "disposing" the case.
I must note that in general, most Examiners do a good job, but the problem ones make for more interesting conversation.
April 14, 2015
Bacteria Can Have Autoimmune Disease
This is great. Bacteria can have autoimmune disease wherein they attack their own genome.
The CRISPR system only memorizes foreign sequences that are being replicated rapidly and which do not contain abundant Chi sites (common in the bacteria, but not the phage).
I was going to comment that it might be a good strategy for the phage to add some Chi sites (about 8 bases). Was surprised to find that Chi sites were originally found in lambda phage.
April 12, 2015
Triplet Code Dogma Amazingly Shattered
It is old news that some microorganisms have mutations (amber, ochre, opal) that allow read through of stop codons. So, it should not be surprising that, out of all life forms, some read animo acids into a "stop" codon, as a matter of course.
Life is flexible. I have done a lot of work on engineered organisms that incorporate unnatural (not of "the" 20) amino acid at a stop codon instruction. Heck, you only need one stop codon, and they have two extras.
The biggest surprise for me was that such "reassignments" were found in eukaryotes, but not Archaea.
April 10, 2015
New Antibodies in the Mutation Race Against HIV
The race is on. While the human immune system is undergoing affinity maturation to strongly target the HIV antigen, the HIV is mutating to avoid the ever stronger antibodies. The article says:
"Broadly neutralizing antibodies are produced naturally in some 10 to 30 percent of people with HIV, but only after several years of infection. By that time the virus in their bodies has typically evolved to escape even these powerful antibodies."
Why don't these broadly evasive evolved HIV become the norm more generally? Maybe difficult antigens low in stimulation and slow to prompt the high affinity antibody. Anyway, no cure. 300x HIV reduction of HIV is not dramatic.
But these are great clues. Further, these antibodies may provide another ingredient in the ever improving treatment cocktail combinations.
See the NBC fluff piece at:
April 9, 2015
Patent Filing Costs
This is a good review of patent costs.
My practice differs a little on the searches compared to the discussion in the article. Most of my clients are experts in their fields (PhD researchers) and are very familiar with the state of the art. We are hardly ever asked to do a search.
For relatively simple inventions, e.g., consumer products, I usually do a quick search on my own. There have been several times a client said he has "never seen anything like it", and I found it right away with a Google search, saving them thousands of dollars.
Although we rarely have a search done, it has been extremely rare that we were caught totally by surprise by devastating spot on prior art during prosecution. There was the time even the Examiner didn't find the devastating art 'til way down the line. Big waste of money, but rare.
Another major difference in my experience is in the cost converting a Provisional application to U.S. Utility application. Typically, in my practice, the cost of conversion is very low. We typically draft Provisional applications and claims so formal that there are no significant changes required to file directly as a Utility application, unless the Applicant has new matter to be added.
Then, there are foreign filing costs ...
April 7, 2015
Contortions in Applications Attempting to Include EPO Claim Amendment Support
I just filed a 150 page patent application yesterday with the intention to prosecute in at least the U.S. and Europe. Last year, I filed the Provisional application with Europe in mind. The inventions involve a generic DNA assay with claims to compositions and methods with many specific examples. I described the assay generically and specifically in a way that would provide adequate support in the U.S. (e.g., with a genus paragraph followed with paragraphs with specific variants of each limitation aspect). Then, for the Europeans, I included paragraphs systematically listing combinations and permutations of all species of each claim element with every other species of other elements.
When the 12-month date rolled around for formal filing, I worked with a European patent attorney and further enhanced the ability of the application to meet the strict added subject matter rules for claim amendment in Europe.
Under Art. 123(2), it is impermissible to add to a European application subject-matter which is not directly and unambiguously derivable from the disclosure of the invention as filed, also taking into account any features implicit to a person skilled in the art in what is expressly mentioned in the document.
1. We started by adding statements that the examples can be used alone or in combination (probably does no good).
2. We expanded comprehensive descriptions of practiced embodiments and embodiments expected to be marketed. The descriptions were in Single Paragraphs, with favored alternates. It seems (absurdly) that the EPO deems the exact same text broken into two paragraphs no longer shows One of Skill in the Art the applicant envisioned the whole concept that was in one paragraph.
3. For each independent claim, we put a paragraph in the Summary of the Invention generically describing the invention and listing alternatives (Markush lists) of each claim limitation. For some reason, the EU attorney suggested such paragraphs provide better claim amendment in the SoI than in the Examples section (anybody?).
4. We took the entire claim set of 150 claims and added it to the end of the application with paragraph numbers. No one can say we did not have support for the original claims. Further, we will be filing a Preliminary Amendment removing most of the claims to avoid excess claims fees in most countries (e.g., if we go into China, the PA will not avoid the excess claim fee).
A lot of this seems crazy to me. If I describe a generic concept with five elements, and describe variants of each element, and I affirm that the alternates of each element will work with the variants of the other elements, it seems unreasonable to suggest I didn't describe the combinations. This is worse yet, when One of Skill would actually be confident that the alternates would indeed function in certain combinations (proposed in amendments).
The European rules literally seem reasonable, but enforcement is perverse. For example, For example, if I describe a generic apple with a size and a color. Then I list large, medium, and small in a paragraph outlining sizes; and red, yellow, and green in a paragraph outlining colors, the EPO WOULD NOT FIND SUPPORT FOR A LARGE RED APPLE!
So, because the EPO rules are soooo unreasonable, we had to address them with a silly and unattractive witch's brew of redundant contortions to convince the EPO we know what everyone reasonable already knows we know - No? Are "features implicit to a person skilled in the art" different in the U.S. because Americans are smarter? OK, emoticon time: ;- )
Seems a few months ago I was reading that the EPO may be loosening interpretation of these rules in favor of Applicant claim amendment support. What ever came of that?
April 3, 2015
Improved Trisomy 21 Detection from Blood Sample
I am not sure what is the "standard" method of trisomy 21 detection compared to the cfDNA technique of the article.
I remember working as a Med Tech years ago and the technique was to stain and photograph the chromosomes of the fetus from an amniocentesis sample. We actually shot a Polaroid instant photo and used scissors to cut out the image of each chromosome. Then, we lined them up according to size, shape, and bar patterns into pairs on a paper chare. If you came up with three chromosome 21 copies, voila - trisomy 21!
I suppose this is still the standard confirmation, using digital equipment.
I assume the cfDNA technique is some kind of quantitative PCR.
April 1, 2015
Quick Assay for Apoptosis Protein Distinguishes Viral from Bacterial Infections
TNF-related apoptosis-inducing ligand (TRAIL), is a protein functioning as a ligand that induces the process of cell death called apoptosis.
See patent at:
This is very important work. If we could exclude half the instances where antibiotics are prescribed for viruses, that would be monumental. Still, there would remain the issues of secondary bacterial infections, and prescribing the wrong antibiotic even when the infection is bacterial.
March 31, 2015
Scientists Joust Over Shrinking Ebola Study Territory
It has been a problem with Ebola that clinical studies can only take place during an epidemic.
Clinical studies in West Africa are ongoing for the tobacco antibody and an iRNA. One group is concerned that "the likelihood of catching Ebola is only big enough in the area around Conakry", the Guinea capital. Another that they "hear rumors that NIH have reached an agreement with the Sierra Leone government to conduct the ZMapp trial in any Ebola treatment unit ...If this is correct, it will jeopardize ongoing trials and lead to conflict" with the TKM-Ebola study.
It may be good news for now that the territories for Ebola clinical studies are shrinking. At least there will be more drug and vaccine candidates available up front next it pops its head up.
March 30, 2015
"Bionic Eye" has Finally Been Tested in Patient 16 Years After Priority Date
Priority Date of 1999 for this technology. Will they be making money before the patent expires?
See a copy of the patented invention:
The "bionic eye" is a photodiode array and the processor sends signals past the patient's damaged retina to the still functional optic nerve. Sounds like pretty difficult micro surgery.
The patient can then see general shapes of doorways, and such. I assume the patient's brain would get used to it and gradually provide even greater resolutions and interpretations of the signals.
Step one. Are some pioneering inventions worth anything?
March 28, 2015
If You Use IPR to Manipulate, Use Due Diligence
Clearly, it is against the law you arrange a short sale of a stock, then disseminate false rumors, to make a profit on the sale. So, at a minimum, such practitioners must document due diligence in confirming the truth of their statements to the public. If they lose the IPR (not statistically likely, lately), this might be used as evidence the public statement was false.
It still seems unfair to buy stock short and then initiate even a well founded Inter Partes Review (IPR). But it is hard to make a case of insider trading on non-public information. I suppose the questionable validity of the stock's patents might be considered public (obtainable) information. And, stock traders are not subject to "insider" trading rules if the information did not originate from within the business of the stock issuer.
But is still seems an unfair advantage over the market when the short buyer manipulates the market and controls the timing of the IPR filing. The stock involved can easily go down 5%, and profits can be huge if the short seller is using leveraged transactions. The money comes from other blindsided stock holders.
Hey, all you lawyers out there, give me some theories on what causes of action could be presented against these IPR filing short sellers - intentional infliction of emotional distress?
March 27, 2015
NewBridge - Place Name TM Allowed If No One Ever Heard of It
This is particularly true if the type of product is not a major industry of the town place, or if the maker is not actually in the place.
Don't try to trademark "Venice" blown glass made in Venice.
March 26, 2015
Fed Circuit Case May Expand Preamble Terms Held to be Limiting
Here is another case that reiterates that one should not describe what is "the" invention in the specification. The case also seems to place far more preamble phrases into limiting terms of the claim.
The preamble, which recited a "repetitive motion pacing system for pacing a user," was deemed limiting because it provided antecedent basis for terms appearing in the body of the claim. Because "a user" was in the preamble before "the user" in the claim body, the preamble terms were held limiting. This case seems to modify the previous case law (e.g., Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305) in identifying any preamble with an antecedent term to be limiting. Maybe we should all start our claims with "a device comprising:"
The article states "practitioners should be careful about using the phrases 'present invention' or 'principal object' of the invention in the specification. As the Federal Circuit in Pacing Technologies found, such statements may serve to limit the claims even when the plain and ordinary meaning of claim terms connotes a broader meaning. Indeed, as the Federal Circuit noted, if a disclaimer is found based on such statements in the specification, the disclaimer may be enforced even if it excludes an embodiment described elsewhere in the specification." This is pretty much old news. However I find they missed a key point - "the" invention. I usually discuss "an aspect" or the "invention, or the invention includes, e.g., " Never just flat out say what "the invention is".
March 25, 2015
Obviousness - My Favorite Subject (Mixing Paint is Way Different From Mixing Grout)
I am constantly using the argument that a combination of references is not obvious because the combination requires the primary reference change its principle of operation (In re Ratti, 270 F.2d 810, 123 USPQ 349), or require the structure incorporated from the secondary reference to function differently in the combination than the original reference (KSR or Sundance v DelMonte, 550 F.3d 1356). Also see MPEP § 2143.01.
I can usually succeed with these arguments against an Office Action, if not on Appeal. These controlling cases do NOT require that the combination changes a principle of operation that was essential to the inventiveness of the cited prior art. However, this fact would apparently be strengthen the fact based arguments.
The "intended purpose" argument seems like a variant of European problem/solution, or even KSR rationales, that structures have to retain function in the combination. What is interesting about this case is that Examiners often argue that the incorporated element has some broadly generic function that covers the claim. Here, such a rejection rationale was not good enough. The PTAB found it non-obvious because the combined element didn't address the more specific intended purpose (not obvious to apply paint in a technique that before applied calking).
Interesting cases - too bad not precedential.
March 24, 2015
Tetracyclene Toxic to All Life Forms - Damages Mitochondrial Protein Translation
This is pretty dramatic. Tetracycline is a broad spectrum bacterostatic antibiotic that blocks protein translation by blocking attachment of charged tRNAs to the ribosome. Mitochondria are believed to be Archaebacteria that provided energy to early eukaryotic cells. Amazing the RNA structures blocked by tetracyclines have been so conserved over the hundreds of millions of years, apparently across all life forms.
It has been known for a half century that tetracycline harms the metabolism of mitochondria. Many functional protein complexes in mitochondria include both proteins translated in the mitochondria, from mitochondrial DNA and proteins translated and imported from the cell nucleus. If mitochondrial proteins are not manufactured adequately, there is an imbalance with imported proteins so that functional complexes are not assembled.
The article makes it clear that tetracycline and tet-on/tet-off expression systems can be a very bad choice, particularly for studies of cell metabolism. Worse yet for the public in general is the huge amount of tetracycline fed to animals intended for consumption.
March 23, 2015
Patent Professionals Must Guarantee the Quality of Documents They File
This kind of client instruction, requiring Counsel to file poorly written documents without modification, is one reason why our firm has received far fewer new cases from certain educational institutions in recent years. They required us to simply file "quick and dirty" versions of their soon to be published journal articles. We have had to refuse such work. A journal article is not a patent application. Modified journal articles often make good Examples at the end of an application. However, in order to receive proper claim scope, and to avoid predictable written description and enablement issues, the specification must be designed with Office Actions in mind.
If nothing else, the client must allow the Attorney to read the document and point out problems that should be addressed. Sometimes the Attorney can at least delete a statement that may be construed as an admission of obviousness, or broaden out a statement of what the invention "is".
In the case discussed, I don't see disbarment, or suspension as the worst penalty. How embarrassing to be dressed down in public by the Supreme Court!
March 21, 2015
Abuse of the PTAB to Make Money Shorting Stock
Depending on the PTAB outcome, the stocks may come back to where they would have been, however, by that time the short sellers and hedge funds have already sold out.
I wonder why the following issue
was not discussed? - If you have material non-public insider information
(knowing the fact you will start third party review of a patent), it is illegal
to trade on the stock. I guess the insider must be a person
associated with the corporation that issued the stock. Still, it seems
they may be transgressing a statute or ethical behavbior with what appears to be
kind of a reverse "pump and dump".
I guess the insider must be a person associated with the corporation that issued the stock. Still, it seems they may be transgressing a statute or ethical behavbior with what appears to be kind of a reverse "pump and dump".
March 20, 2015
Drugs from Federal Financed Research Do Not Reach Market without Patent Protection
Here are some data that starkly demonstrate the value of patent "monopolies".
"Prior to the passage of the act [Bayh-Dole - allowing Universities to license out inventions], no drugs had apparently been commercialized based on the results of the government R&D spending. Subsequently over 183 drugs have been developed", once the Bayh-Dole act allowed technology transfer.
Some argue that patent rights provide no net benefit to society. This is strong evidence that they do.
Some argue that the research was with public funds and should be placed in the public domain. However, note that the public did not benefit from the previous inventive drugs without patent protection. Further the public is paid back many ways - jobs, motivation for more drugs, and money back to the education system.
March 19, 2015
More Stable Second Generation Formulations are Obvious in India
Section 3(d) of the patent act prohibits grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance. In this context "enhanced efficacy" apparently means enhanced therapeutic effect. They say just because you find a new more stable formulation by trial and error, this does not mean the new formulation is inventive. However, if the formulation is not a drug, such improvements are inventive. Hmmm.
Even if India had not withdrawn the issued patent to the more stable tiotropium formulation, no one can make the drug until its original patent expires. There is no "evergreening" because when the old patent expires anyone can practice it. The only difference is that now anyone can also practice the more stable formulation. But this right is traded off for the reduced motivation to discover such formulations and to practice them in India.
I believe the new formulation is inventive, e.g., because it is not obvious. If it was not inventive, why didn't Boehringer use it as the original formulation? And since when is the unexpected result of trial and error experimentation not inventive. I worked in Formulations and Stability in large pharma for many years, and I can tell you formulation improvements are not obvious.
It seems the India Patent Office has set up a separate standard of inventiveness for drug formulations for political, not scientific, reasons.
March 18, 2015
Young Man - Terminate Your Copyright Transfer
Like co-inventors (joint ownership), co-copyright holders have independent (separate) rights.
Certain artists that gave up their rights after 1978 are eligible to terminate the transfer after 35 years. See: http://www.copyright.gov/docs/203.html
Here, Victor Willis (Village People Cop) seems about to have his 50% interest in several songs returned.
March 17, 2015
Slow Browning Apples Proud to be GMO - Patented and Now FDA Licensed
The second FDA licensed GMO fruit is out. Arctic®Apples have an RNAi that suppresses polyphenol oxidase (PPO) enzymes that cause browning in cut or bruised fluit.
CSIRO uses the ARTIC trademark to label the apples, e.g., Arctic®Fuji as GMO in the market place.
CSIRO has apparently licensed the PPO sequences. I am not sure why. The PPO sequences are not cloned into the apple products. In fact, the Artic apples suppress the PPO genes and I wonder why CSIRO did not just delete the PPO genes, or at least the most browning inducing isotypes. Like many genes, there are multiple functions (beyond browning of fruit) that may make deletion deleterious or lethal. Anyway, CSIRO went the route of RNAi (RNA interference with complementary mRNA target) to inhibit the enzymes.
Maybe CSIRO licensed the PPO genes to avoid law suits around the use of the genes in the design of the particular associated RNAi sequences. Of course the issue of PPO gene patent claim validity (35 USC 101 subject matter eligibility) has to be mentioned here. If the PPO gene patents include only natural sequences the claims may be invalid. However, I suspect the RNAi sequences are directed to cDNA (mRNA) sequences found eligible for patenting by the Supreme Court in Myriad (unless, e.g., the sequence does not bridge an exon?).
Cool article - patents, trademarks, licensing, GMOs, you name it.
See PPO gene patent at:
See RNAi patent at:
March 16, 2015
Requirement to Report All Clinical Study Data Mostly Ignored
Scientists know that negative results are often more valuable than positive results. Some of the greatest scientific breakthrough of all time were based on negative results. If the haldron collider had not found the Higgs boson, that would have been as monumental as finding it.
I see that FDAAA 801 establishes penalties for responsible parties who fail to comply with clinical study summary release. These penalties include civil monetary penalties (up to $10,000/day), and for federally funded studies, the withholding of grant funds.
See UCSF PowerPoint at: http://health.usf.edu/NR/rdonlyres/06665185-29B7-47EA-A42A-02D49C038167/44956/ClinicalTrialsgov2813.pdf
Apparently, as with many other laws on the books, there is a lack of enforcement. Clearly this is the reason for universal lack of compliance.
March 15, 2015
PTO is Serious (Again) About Enhancing Quality of Prosecution
Feeew. Scared me. Last time the PTO was concerned about "Quality" they thought it meant not issuing any patents for fear a "false positive" allowance might occur. I remember an Associate Director gave a talk back in those days at a "PTO comes to the Bay Area" conference. He went on and on about quality. See how the false positives are down. I got to the microphone and asked him how the false negative (rejections of valid claims) was going. He made some funny sounds and didn't have an answer that made any sense.
See the new Quality Initiative Request at:
The Six Quality Proposals (my comments):
Proposal 1. Requests for quality review in a particularly bad Office Action. Applicant who receives a very low quality office action would be able to seek review in this more informal manner without appeal or RCE. Currently, I use Request for a PreAppeal Review Conference. Just today I got a Decision in my favor. Usually embarrasses the Examiner into being more cooperative. But, wouldn't it be great when you get a totally ridiculous Office Action if you could just have someone with power, and no skin in the game, give a reality check (without making the Examiner mad)? It would be worth a lot if Examiners had to worry early about being embarrassed by bad or lazy work.
2. Seems a combination of an automated search and the best (of the few IDS references;) would be a good starting place for pre-examination review.
3. Thank God, some years ago the PTO finally made available OCR .pdf copies of the files. Still, I have to do major review and editing if I want to quote the Examiner, or get a copy of the claims for a case just transferred in (anyone ever have a client who could not find a copy of their specification or claims?). Yes, .xml files would be nice.
4. The PTO motivation system and Examiner performance are intertwined. The Examiners are mostly focused on how to please the PTO and earn their motivating points, often to the detriment of fairness and the quality or expense of the patent. Things are better than the bad old days when Examiners were extremely frightened of allowing a case, for fear they missed a detail and made a dreaded "false positive" allowance that could ruin their career. Still, I routinely receive Office Actions with all claims rejected, with some claims actually having no rational reason on the record for non-allowance. Why can't they just allow a narrow dependent claim now and then, if it is not arguably obvious? /span>
5. I have stopped using RCEs, and have filed more Appeals (including Requests for PreAppeal Review - PARC) in the last 2 years than the previous 10 years. I set things up in the first Response, and when I am right, I am right. Time to Appeal. It is good that the PTO now facilitates negotiations in the After Final Pilot Program where Examiners get credit for entering agreed amendments after final.
There is one thing about the Pre-Appeal Review program that should be fixed - The Decision says nothing. If there were three issues and the Review Committee agreed with Applicant on two of the issues, all the Decision says is "there is at least one issue remaining for Appeal". So, I only use PARC for cases where there are only 1 or 2 simple issues to be addressed.
6. I am pretty convincing over the phone. Still, I am sure person to person would be effective and I look forward to Interviewing with Examiners here in the Bay Area, once the opportunity comes to fruition.
March 14, 2015
Clueless About Risk/Benefit Ratios
Wow, talk about lack of informed consent. Are your client/inventors clueless too?
This meta-analysis finds a patients are almost never well informed about the risks and benefits of procedures and drugs.
I don't know what can be done. People are hopeful and only hear what they want to hear. I see this all the time in my patent practice. At the outset, I tell the clients about all the costs and delays inherent in patent prosecution, then they wonder why their case is not issued at low cost in 18 months.
It is worse in medicine. At least most people have a clue about time and money. Try to explain to a plumber about his pancreas.
The best we can hope for is a benevolent dictatorship. Well informed doctors with all the information, prompting us toward the best decision. Problem is, I have seen doctors biased for me to have a surgery with no net benefit (setting broken clavicle with metal plate) just because I was insured.
On the positive side, maybe "precision medicine" can change some of the risk/benefit ratios for the better in the future. As a patent practitioner, I try to keep up to date on patent allowance trends, generally and in my office, so I can answer the question - "What are the odds this case will be granted?"
March 13, 2015
They Say We Actually Get the Flue Only Every 5 Years.
Personally, I don't remember getting the flu more than a few times in my life. Probably, I have been sub-clinical a lot of times. About once every 2 years sounds as I expected for kids.
I am not sure how this study could have worked. They used the word "assumed" a lot, but they must be right, because they used calculus. I did wonder about how they resolved whether the antibody titer against a strain was due to an actual infection and a vaccination. Because immune responses from actual infection are stronger, and to a larger variety of antigens, it could have been possible to determine whether titers were from vaccination or illness. This, particularly if vaccination records were available. However, at one point, they did mention "note that we do not distinguish between live infection and vaccination in the model."
See the journal article, here:
I wonder if the frequency of infection eventually goes back up with age? I
wonder if people with kids get the flu more than every 5 years?
You are Not in Control of Your Drug Licensing Path
A lot of new drug candidates are not identified by understanding some brilliant relationship of structure and function. Many drugs are discovered by accident (e.g., penicillin). So keep your eyes open.
There are usually some animal studies before the human Phase I study. If the drug works in animals, they test safety with low doses in human volunteers (Phase I). Now you have spent a lot of money and usually have no data on whether the drug works or has significant side effects at effective doses in humans.
Sometimes clinical studies do not go well. If the FIRST Phase III study suggests a different end point than the design, or if the database is not large enough to confirm statistical significance of an end point (see Cetus' IL-2, Proleukin) you might elect to go on to a second Phase III study.
Not an easy path.
March 12, 2015
Colors Prefiltered Before They Arrive at Cones and Rods
Apparently color vision does not depend just no the absorbance frequencies of the cone cell pigments. This article suggests there is some prefiltering by the layer of tissue in front of the light sensitive cones and rods in the retina.
Still, I have a little trouble with the article. They discuss "light guides" and "piping" suggestive optic fibers. However, light pipes work on the principle of reflection (from the inner walls of the pipe). This looks more like a diffraction phenomenon to me, e.g., more like a grating.
What do you think?
New Era - NYT Says Most Brand-Name Drugs Eventually Lose Their Patent Protection; First Biosimilar Licensed
Amgen used to be the only maker of granulocyte colony stimulating factor (G-CSF, under the name Neupogen. A synthetic DNA sequence encoding human G-CSF was expressed in the bacteria E. coli (OMG No, a GMO!) and purified as a drug to treat certain cancers.
Now, the FDA has licensed a similar product, probably manufactured at a lower cost (low R&D and more efficient modern manufacturing processes) to be sold by the Novatis subsidiary Sandoz.
March 11, 2015
Federal Judge Says Dentist Has "Unclean Hands" (In Equity)
More On the Dentist Who Forbade Negative Reviews and Claimed Copyright to Reviews
The Dentist really hated bad reviews. Tough business. Probably got bad review for a reason.
The Dentist's "contract" apparently included fines for bad reviews. To fight the reviews he fined his patients and claimed copyright to the reviews.
The Fed Judge found against the dentist based on first amendment commentary and "unclean hands" for the Dentist bad acts in equity.
Imagine being a dentist labeled by a Federal Judge as having unclean hands. Gross. The Dentist has disappeared and there is no expectation the patient will collect his 45000 or that the dentist will ever practice in the U.S. again, under his real name.
March 10, 2015
Newest Estimate of the Average Cost of Bringing One Drug to the Market $2.6 B
Finally an estimate that includes all the costs, especially the costs of failures and R&D. OK, and another cost non-economists do not understand - the opportunity cost (money investors would have made in another investment over the years it took to make it to market; not just the money back they put in). Anyone wanting free drugs likes to ignore these costs.
Good news is that the cost of IP protection is only 1% of the development cost. We are a bargain.
And, of those drugs making it to market, only 20% ultimately make more than the average $2.6 billion to get their money back. In those 20% are blockbusters that earn back 10x the investment. In that 80% are a lot of failed projects in big companies, and small companies crashing when their clinical data does not match the animal models.
So, if governments around the world want to pay a "fair" price for successful drugs, they should also pay a premium over the present cost to manufacture the successful drug.
March 9, 2015
Indian Formulations Taste Better - Not a Trade secret Any More
No wonder every old Indian mother has a trade secret masala formulation. "What is the recipe for this great curry?" - A little of this and that and masala. "What masala?" My masala. "What are the ingredients of your masala?" I can't tell you.
Now "science" has figured out the main secret to a good Indian dish. The spices all have different flavor ingredients. Cardamom is different from cinnamon, from mustard, from garlic. None of this black pepper, red pepper stuff..
Ok Yeah, a big mistake in the article - chicken tikka-masala is not Indian (English) and tends to taste more like Spaghetti-Os.
March 8, 2015
Rockets - What Good are Method Claims With Steps You Can't Practice Within One Country?
Funny thing about spacecraft methods, even if you make the rocket in Russia and have a patent there, all you have to do is practice the actual method somewhere else.
In fact, the spaceship landing is on a barge, out in the ocean -international waters without any patent enforcement jurisdiction. Too bad they did not file in Vanuatu.
March 7, 2015
Mustaches Popular at the PTO During Mustache Week
Some of those mustache trademarks look pretty similar. Good thing they are not in the same international class.
I had a beard and mustache for 15 years. Started when I went on a long trip and did not want to have to shave every day. When I finally shaved it off (working in pharma manufacturing, it was inconvenient), my little daughter did not even recognize me.
Mustaches have gone from about 50% of men in the 1870 to only about 10%. The real looser seems to be sideburns. See:
March 6, 2015
Why, Why, Are Men the Way They Are?
Another good example of how biased population sampling can lead to the result one wants to dramatize. You think this study of XYY men was good, maybe someone should do a non-biased study of XXX women in a population of exotic dancers.
I suspect this is another example of non-scientists (non-statisticians) carelessly (or intentionally) sensationalizing a "human interest" story to up readership. Not that there is anything wrong with that.
March 5, 2015
Of Rats, Fleas, Lice, Gerbils, and Other Cute Disease Carrying Creatures
There has been a lot of press lately about the fact that waves of the black death plague - Yersinia pestis) in Europe corresponded with peaks in giant gerbils in Asia. See - http://www.npr.org/2015/02/28/389595442/rats-blamed-for-bubonic-plague-but-gerbils-may-be-the-real-villains
Some of the press misunderstood and assumed that the Asian gerbils were directly infesting Europeans with fleas. However, I believe the population of gerbils and their fleas in Asia went up, causing an increase in plague in Asia. Then, caravans from Asia reseeded the plague in Europe.
Note, it the cute little prairie dogs that carry plague now days in America.
Anyway, this article is correct that the black rats infested the Europeans with the fleas, once the disease was passed in from the Asian gerbils. Wow, this is the first time in almost 100 years that a survey of rat body insects has been completed. I would have though some undergrad would have had the privilege at least once a year!
March 4, 2015
How Do You Promote Effective Early Communications with Potential Clients?
1. How many potential clients have left a long clear message, then rattled off their phone number like an indecipherable machine gun? My answering machine says - "If you want me to call you back, please say your phone number slowly and clearly."
2. Small clients often want their patent services local. However, I explain to them that I don't actually see most of my clients during the prosecution of their patents. My first patent was for oil drilling equipment invented by a couple living in Australia, whom I never saw. With modern (inexpensive) communications, face to face is not absolutely necessary (if not as efficient).
3. There is nothing riskier than giving an opinion. I will only give them with all the realistic liability reducing caveats. This can never be done in a rush, particularly without all the information. And,... it doesn't hurt to get paid for it.
4. Many small clients are so uninitiated that I actually enjoy the free consultation because the time is so valuable to the potential client. Arranging a consultation with the client, I systematically list the materials and information that would be most useful in evaluating their case. With all the information, it is much easier to make an estimation of what their costs will be to the point of filing an application.
March 3, 2015
It's a Suture, It's a Glue, It's Super Clot
At first I thought this stuff was superglue (methyl 2-cyanoacrylate,) and I wasn't too far wrong.
The technique calls for n-butyl-2-cyanoacrylate (previously sued as an instant glue suture for wound closures) to be injected from a catheter directly into a varicose vein. The glue can not travel far because it rapidly polymerizes in the presence of water. Even though it looks like two poisons (cyano acrylate), it is apparently safely biodegradable.
I assume the veins shrink and fibrose before the glue biodegrades, leaving slender beautiful legs.
March 2, 2015
If You Can Not Patent the Old, Make It New By Putting It in a Truck
A patent on delivering products by printing them on a truck near your house.
Am I dreaming? The first claim (see hyperlink to patent application, below) is to "A computer-implemented method". Are they asking for an ineligible subject matter rejection?
See patent at:
Can this not be obvious based on the prior art? Of course, the claims will be narrowed, if they make it past parent eligibility requirements.
March 1, 2015
Boeing Patents Aspect of Multiple Lift Carrier Satellite Launcher
The patent is not actually claiming a four stage launch system. Here are the claims of the patent issued:
1. A vehicle comprising: a first stage aircraft; a second stage aircraft; and an interstage coupler for coupling a nose section of the first stage aircraft to an aft portion of the second stage aircraft's fuselage prior to in-flight separation, and for decoupling the first and second stage aircraft to initiate in-flight separation, wherein the interstage coupler includes a plurality of retractable arms spaced about a perimeter of a nose section of the first stage aircraft, first ends of the arms hinged to the nose section, and second ends of the arms securable to the aft portion of the second stage aircraft.
The "patented vehicle" does not actually include a four stage system. There are a lot of two stage (jet with rocket) or three stage systems that have been conceived. All that aside, I still think the overall concept of multiple specialized lift vehicles is a good one, if unpatentable (e.g., obvious).
February 28, 2015
For a Half a Billion Dollars, Couldn't They Just Deem the Software Claims Patent Ineligible?
I don't hear anyone shouting invalidity.
I'm sooo smart (how smart am I?) that I could carry out all those claim steps in my head. Therefore, I deem the claim ineligible subject matter!
See claims at:
February 27, 2015
February 27, 2015
Short DNA Comes Up Short in Patent Eligibility
Certain claims at issue in the original Myriad case were "15-mer" sections of the BRCA sequence. Such claims have been found not to be patent eligible subject matter, particularly since being "isolated" no longer cut it.
Another problem, though, with short sequences is that they are not new. Apparently, there were thousands of sequences throughout human and other animal chromosomes that have at least a 15 base sequence also found somewhere in BRCA. So, even if the 15-mer were patent eligible, there would still be the issue of (inherent?) anticipation or obviousness. It is hard to patent short DNA sequences without "something more" than isolation, or unattached 5'/3' ends.
February 26, 2015
If You Can Not Patent the Old, Make It New By Putting It in a Truck
A patent on delivering products by printing them on a truck near your house.
Am I dreaming? The first claim (see hyperlink to patent application, below) is to "A computer-implemented method". Are they asking for an ineligible subject matter rejection?
February 25, 2015
California Wants to Determine if Drug Cost is Reasonable
The one cost they left out in their "transparent" evaluation of why drugs are expensive is the cost of the nine other drug candidates that failed, but have to be paid for by the successful drug.
What goes 'round comes 'round. Maybe someone should see if California costs are reasonable.
February 24, 2015
Rid of Your Allergies for Peanuts!
Desensitization, or is it familiarization. I used to be allergic to my cat. I kept is, and not no allergy at all. When is our culture going to move away from "protecting" children from routine exposure to the natural world?
Anyway, good news on peanuts, and now on to other allergens.
February 23, 2015
More Details on How Bacteria Remember and Attack Phages
In hindsight, we all knew that prokaryotes had to have some mechanism to archive a memory of a phage attack. So we have "adaptive immunity" in bacteria. This has been known at least since 2007. However, the present article outlines some of the mechanisms of the CRISPR complexes.
Viral DNA Nucleic acid sequences of phage genomes are actually stored in individual bacteria so they can pass on the memory of previously contacted phages. This allows the bacteria, and their progeny, to block replication of the same phage through a form of RNA interference.
It is most interesting here that the phage sequence is stored in the bacteria without a "PAM" side sequence that is recognized by Cas9, thus targeting only the PAM containing phage version for miRNA cutting. Otherwise, the system would cut its own archived phage sequences.
I wonder how much space is dedicated to these archives in bacteria and how they turn over with time.
February 22, 2015
Side Effects of Anti-Addiction Drugs
All is in balance. You can not get something for nothing. The addictive drugs may provide pleasure that is paid for in pain. The anti-addiction drugs, the same. Some are fairly effective, though, when the user is motivated.
February 21, 2015
TATA IP Strategies Still Seem to Reflect the Old Monopolistic Days
First time I was in India (1980s), about the only truck maker was TATA. I was told they were licensing ancient German designs. No competition at the time do to huge import taxes. They essentially had a monopoly on several other industries also.
Now, I see this article. TATA Group conglomerate, boasts around just 60 patents.
Also ..."so there is a lot of emphasis on trade secrets, but formally there is no policy on trade secrets." Boy, that is a good one. If you have no policy, you in fact do not have enforceable trade secrets at their U.S. facilities (could the law be so different in India?).
No problem, TATA gets around this by "managing knowledge" with a company policy dictating that every year engineers must submit three or four papers among their colleagues, who then rate the work they have produced. Thereby knowledge is captured and organized in a way that it can be re-used, and that the re-use of IP helps productivity. Too bad this does not generate any intellectual property if they do not patent and don't know how to protect trade secrets. Hmm ...
I see, on further research, that TATA actually now has about 90 patents in the U.S. and about 250 applications pending.
I wish them well. It is hard to dig yourself out of an earlier lack of competition. Too bad the Nano microcar project did not go better.
February 20, 2015
Beware of Overbroad "Reasonable" Claim Term Construction.
Construction of claims is often broader in the PTAB than by Examiners in prosecution or the Federal Courts. Here, the PTAB finds any sequencing of fetal DNA generally also (inherently) sequencing the "predetermined sequences" of the claim. See patent at: https://www.google.com/patents/US8296076?dq=8,296,076&hl=en&sa=X&ei=4ATmVIqrF4S0yQTvvoEQ&ved=0CB4Q6AEwAA The PTAB deems sequencing of predefined sequences does not require predefined specific sequences to be targeted in the sequencing. Thus, opening up the scope relevant prior art for the 102 rejection.
In another case I am familiar with, claims requiring "sequencing" have been rejected based on art wherein a possibly complementary nucleic acid may HYBRIDIZE to the sequence of interest, e.g., even though this does not require 100% identity.
In these cases, the reviewers fail to construe the terms according to what one of skill in the art would believe in light of reading the specification. I know some patent practitioners cringe at the suggestion of providing express definitions in a Definitions section of the specification. However, I believe key claim terms should be unambiguously defined so Examiners and the PTAB cannot suggest far out interpretations are "reasonable". As a back up, you can always include other descriptions of key elements having alternate scope as support for amendments.
I believe Stanford is appealing this PTAB decision.
At least this case is not rejected for alleged ineligible subject matter.
February 19, 2015
Experimental and Regulatory Use Exceptions for Patented Drugs and Devices in China and U.S.
In the U.S. the rules for non-infringing "experimental use" are more strict than China. This is generally acknowledged as the countries tailoring policies to their more or less developed high tech and biotech manufacturing environments. One assumes China will become more strict when they have more to lose from infringement exceptions.
In the U.S., use of patented inventions must be for non-commercial "amusement, to satisfy idle curiosity, or for strictly philosophical inquiry." A further exception in drugs (and medical devices) is provided in Hatch-Waxman framework, 271(e)(1) broadly encompassing any use reasonably related to the development and submission of information under a federal law that regulates the manufacture, use, or sale of drugs or veterinary biological products (and medical devices). This includes preclinical testing and testing data not ultimately included in the drug application. Drug manufacturers are strictly prohibited from using a patented invention to develop their own different product.
Initially, China was the opposite, with it being OK to copy an invention to make improvements, but not in the field of clinical experimentation. Lately, this has been expanded to generally allow experimentation in all fields to characterize and/or improve the invention, even for business purpose. In clinical inventions, China still does not include a patent term extension to make up for time lost in regulatory review.
So, generally, China is more open in exceptions to "experimental use" of patented inventions without infringement.
February 18, 2015
Did They Steal Monopoly or Only Fame?
It appears Elizabeth Magie Philips deserves a lot of credit for outlining and inspiring the current Monopoly game. However, she was apparently not good at marketing.
She apparently applied for a patent in 1903, but never generated much interest or sales. Patents last 17 years. Darrow had a popular different version of the game, sold to Parker Brothers, apparently not infringing because Ms. Philips only "complained" in 1936. She may have had a copyright, but the Darrow game apparently looked quite different.
I do not see Ms. Phillips as a victim, based on the facts. She did not self-promote or market well. Good she at least gets some recognition now, but it does not appear anyone stole any property from her.
February 17, 2015
Fake Journals Targeting Poor Helpless Developing Country Researchers
"What angers Shrime more than anything is that fake journals seem to target doctors and researchers in developing countries for whom $500 is an enormous sum of money. 'When you dig into these publications, it’s clear that the vast majority of authors on their table of contents come from lower-income countries,' he says. 'They’re preying on people who aren’t able to get into the mainstream medical journals because they come from a university that nobody recognizes or they have some other scientific disadvantage.'"
This comment assumes developing world researchers are not smart, and that scientists with little money don't carefully consider how they spend it.
If research is good it will get published. The respected journals are not in the business of brown nosing expensive schools or disrespecting foreigners (though good English writing skills can be important).
Robbers don't target victims with no money. Sellers search for a market with demand. Here, developing world researchers have generated a demand for publishing services. The bulk of the demand for these services is from scientists that are intentionally padding their resumes. See, for example, the enormous pressure in China to publish, any way you can - http://phys.org/news/2013-11-reveals-black-china-paper-authoring.html
February 16, 2015
Bionic Leaf Process May be All Wet
I recently read another article (http://www.greencarcongress.com/2015/02/20150210-silver.html) that stated a 3% efficiency using the direct cobalt catalyst creating the hydrogen/oxygen from sunlight to feed the bacteria generating isopropyl alcohol (IPA).
The suggestion to use photoelectrics (at least 25% efficient with energy conversion to electricity) for electrolysis (high efficiency) to make hydrogen (and separate useful oxygen) would very likely produce an overall IPA conversion efficiency overall of at least 5% (in a controlled bioreactor). Then, one would have to separate the IPA from the water and bacteria. (Boy, this is getting complicated.) Maybe they could feed the excess biomass to goats.
Possibly, it would be better if we could just keep working on a better way to store hydrogen (for internal combustion or fuel cell).
(Anyone think I use parenthesis tooo much?)
February 13, 2015
Biology Soon to Conquer Electronics in Information Technology (With a Little Help From Electronics)
It is awful tempting to use the amazingly compact information storage of biomolecules.
The slow aspects of molecular data storage have always been read/write. However, e.g., with variants of maturing massively parallel sequencing technologies (e.g., ion torrent or fluor torrent), we may soon be able to challenge the supremacy of electronics even in rates of data transfer. For example, with the nanocell volumes and molecular solution kinetics read/write could be fairly fast. In certain embodiments, parallel read/writes in multiple cells could speed the process and even provide error correction.
February 12, 2015
Improvements are Patentable, but Obvious Prior Art Combinations Don't Have to Be Improvements
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor. That does not mean that obviousness analysis requires that combinations of art in rejections must be improvements over the art.
February 11, 2015
Aluminum Cell Battery - Fill 'er Up
Like they say, this is a primary cell and can not be recharged by simply reversing the voltage. To recharge a car, one would have to install a hundred pounds of ingot anodes. Can't pump them in, but should be able to devise a simple way for a machine to do it.
Finally, to reach their price point, they would still want to recycle the aluminum oxide hydrate slurry back to metal.
Overall, it might be simpler way to convert electricity to a battery fuel than production and storage of hydrogen.
Thanks, Victor, for the interesting article.
February 9, 2015
Tractor Manufacturers Use Proprietary Software to Tie Hands of Farmers
How frustrating. I remember my uncle Jimmy in the Montana Bitteroot Valley when I was a kid used to do all his own work on the bulldozer and tractor. Not sure about the "combine". I can just see him now, black grease up to his elbows from doing routine maintenance at the end of the day. He was mostly a potato farmer.
I just put a computer programmable ignition system in my 42 year old 240Z. What a mistake that was. Made the car a little faster, but less reliable. I also do my own work on my modern pick up and wife's BMW. It is great that government stepped in years ago and required a common standard for the OBD (on board diagnostics) systems by all auto makers selling in the U.S. Lately, I have been using a $30 OBD blue tooth device and my smart phone to talk to the computers in the cars. Without that, I would have to pay Ford and BMW.
Real shame the big tractor manufacturers are playing an IP game with the farmers. I can't see the government stepping in. Maybe the farmers could have a boycott, or bargain for better access to their black boxes. It is clear the manufacturers are reducing the value of their product to the farmers with these practices. Maybe the first manufacturer with open code will receive a windfall in sales.
I do not work in software IP much. Seems strange that it would be a patent infringement to look at the software or modify it. Probably a click-through software licensing agreement is the basis for this abuse of the farmers. I am sure the restrictions are not even mentioned by the tractor salespersons.
February 8, 2015
Digital Rights Management (DRM) Can Make Enemies of Your Customers.
I quit buying HP printers the first time a refill of their own cartridge was not recognized. Worst yet, I had an original first use HP cartridge I took out to clean and the HP printer would not use it because it assumed their own good cartridge was a refill, even though it was still half full of original ink. So mad, I vowed to never do business with HP again. I never go back on these vows (there is a long list). (I wanted to vow not to deal with ComCast again, but didn't because they are no worse than the whole list of dishonest and manipulating ISPs and cable providers.)
It is a bad idea to make it clear you do not trust your own customers, even if some may be infringing IP (intentionally or not).
Anyway, my staff insisted just last week that we get a Keurig coffee maker. I argued against because the machines are so complicated, they always break down. They finally talked me into buying a cheaper model; still uses the old cups. No cup reader, and I intend to use what ever cups are the best deal. If the machine breaks down too soon - "I will never buy another Keurig product again."
February 7, 2015
Should an Invention be Patent Eligible if We are Allowed to Experiment ON (not WITH) the Invention?
So, with all that, we know that we do not know where we stand on experimental use of a patented idea.
The article repeatedly tries to raise hope that experimentation ON the invention should not be considered an infringement. Meanwhile, experimentation WITH the invention is infringement.
The play of words seems to be in some fanciful hope that if it is clearly held experimentation ON an invention is not infringement, then a key policy basis for the recent tightening of subject matter patent eligibility would dissolve (just like government was supposed wither away to under communism). Not likely. That is, if experimentation on an invention is not infringement, researchers can continue making improvements, and maybe it is OK to allow patents.
If such ideas could remove some of the gut feeling "unfairness" the SCOTUS seems to feel about monopolistic patenting of mankind's heritage, maybe the next wave of patent eligibility decisions 20 years from now will swing the pendulum toward greater eligibility, a little.
February 5, 2015
Upgrade Your Children's Mitochondria
Mitochondria are critical to our vigor and ageing processes. See, also:
“In reality, it is a macabre form of eugenic cloning, in which a human being with a medical condition is killed and his or her parts are used to create a new human being with an improved biological state,"
Not true. There is no 46 chromosome "human" that is ever disassembled or killed. The donor egg loses it's nucleus, the mother's cytoplasm (and bat mitochondria) are discarded. Then a reassembled egg is fertilized into a potential baby. In the course of a woman's life time almost all of her 100k+ eggs are lost, but all but the most politically driven would label eggs human.
The whole thing is a little strange, and not too useful, yet.
February 4, 2015
"Patent Pending" Provisional Rights Against Infringers
I often inform clients that they have certain rights against infringers while they have a published patent pending. Today, I decided to look into this further. The story is not pretty for patent applicants.
After an inventor (Applicant) has a pending patent published, they can give notice to an infringer and eventually get damages (reasonable royalties) if the infringer continues to infringe and the patent issues with ‘substantially identical’ claims to those published. See, 35§154(d) - http://www.law.cornell.edu/uscode/text/35/154
Case law essentially holds that the issued claims are substantially identical if they have the same scope. In particular, claims can be amended and remain substantially identical if the scope has not narrowed. I can argue both sides, but this seems odd to me. Sadly, the case law does not reflect the fact that "substantially" means "being largely [mostly] but not wholly that which is specified" - Webster's.
The case law seems to hold that any small narrowing of the claims means they are not substantially similar. But, suppose the issued claims end up broader. Then, the infringer has not had adequate notice, and was caught in an expanding trap. Not fair. On the other hand, if the claims are narrowed, the party given notice may not be considered an infringer because the narrowed claims shrink away from what the party given notice is doing. The potential infringer given notice has avoided the net. I guess the policy reason for not providing pre-issuance damages for narrowed claims is so Applicants do not use initial broad claims to scare possible competitors, and so that Applicants present claims likely to be non-obvious and enabled.
One holding I find particularly unreasonable is Honeywell Int’l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1140 (Fed. Cir. 2004) (en banc), where issued dependent claims are given no respect before issuance. See - http://caselaw.findlaw.com/us-federal-circuit/1371896.html Where a parent claim incorporates a dependent claim in an amendment during prosecution, it still has the same scope as the originally published dependent claim. Yet this is somehow considered to be a narrowing amendment of the invention provided in the notice. I haven't read the case, but doesn't make sense because the infringer was in fact given notice of a published claim that issued.
The law subjecting pre-issuance infringers to damages was written to keep people from stealing inventions during "patent pending" prosecution and to motivate Applicants to publish. Near as I can tell, the law is a joke since it is construed so narrowly that in practice it is rarely enforceable.
February 3, 2015
President Would "Save Money" by Reducing Drug Patent Terms.
Certain people are quite willing to trade greater long term benefits for short term rewards. That's why some people drop out of high school, and why some would rather have goose now than golden eggs later.
Yes, the government can save money by taking money out of the pay back period needed to make up for research and licensing costs of the pharma industry. No one will notice later that certain patients will not receive a cure for their disease because government has taken money that could have found a cure. At least certain people can feel good showing the short term benefit, and can paint the drug company fat cats as bad guys.
The government would save "$3.5 billion in federal health spending over 10 years." To follow through with the logic of the policy, Maybe the government should do away entirely with exclusivity periods for all name brand drugs. Then, they could save $7 billion in the short run (and no one would even notice the good politicians policy led to the deaths of thousands around the world that never get treated in the long run with drugs never developed).
February 2, 2015
Japanese Policy on Invention Ownership Not Working and May Change Again.
If someone invents something, they own it. If they invent something using some one else's facility, with an employment contract stipulating all work related inventions will be assigned to the company, then the inventor is an inventor and the owner of the patent application is the employer. What business would employ someone to do research, and pay for all the overhead, then agree that any inventions belong to the employee?
Inventors should only be "furious" if they a company takes their invention without a previous agreement that inventions would be assigned to the company. If there is no assignment contract, too bad for the company.
The article erroneously states that the "U.S. is able to acquire many global elites because they insist on giving large awards to innovators and contributors." This is generally not true. Many global elites start their own businesses in the U.S. and are both owners and inventors of their creations. Most scientists in America have Assignment clauses in their employment contracts that require all work related inventions will be owned by the employer. In exchange, the Scientists get guaranteed high salaries whether or not they stumble upon a breakthrough. Many highly successful biotech companies pay very high salaries with great fringe benefits, but stipulate that if the Scientist does not publish and patent, they will be "let go", e.g., after 5 years, or so.
A contract is a contract. Both sides benefit, or they would not sign it. A patent law requiring negotiations up front between Researchers and their Employers is a good idea, so any unsophisticated party is not taken by surprise, in the rare event a great invention is created at work.
January 31, 2015
Non-Scientists Disagree with Scientists on Science.
It might be argued that scientists are too close to science to have unbiased opinions on the subject. Balderdash!
Should uneducated people make decisions about science and technology, based on the teachings of Associates of the Arts? That would be democracy. The fifth branch of government is the media. Problem is, media seems biased toward reporting sensational black and white stories where there is an antagonist and victim. However, this is wrong. Everything is life is a trade off. A balance of factors pursuing the optimum benefit - like life itself. In the long run, have there been more lives saved by pesticides feeding people, than poisoning them? Haven't the scientists monitored and removed the worst culprits, like DDT?
All GMOs are bad. Or so they say. What if a GMO provided an inexpensive oil (as food and fuel) in brackish soil? Would that be worth the risk that a foreign gene would disturb the overall balance of genes in the plant, leading to production of a toxin that would slowly kill half the population before we noticed what was happening (I am not making this up)?
We should have more scientists in the media. They are actually popular entertainers with their whiz-bang stuff on radio and TV. Problem is, scientists like science (and journalism is a crowded field, paying little). So ... should scientists just keep saving lives and pay no heed to ignorantly biased influence of the media? Hopefully, success in science (green energy, cancer treatments, speedier communications) will continue to engender some confidence in science from the general public (without the help of talking heads).
More mandatory STEM (science, technology, engineering and mathematics) education in schools would help a lot, so high school graduates working in any profession could have educated skepticism of any claims.
There has been a lot of talk about STEM lately (and during the space race 40 years ago). Seems the problem is the competition with Federal Standardized Testing requirements for classroom TIME (the problem is not necessarily money; everyone was poor in Montana when I grew up and we were always at the top of the math scores).
January 30, 2015
Inventor Heroes Get Out
of Jail Free
Perversity again in China. Things can look good on paper (remember the Constitution of the USSR?) but lead to perverse results. Especially still, sorry to say, in China.
Write a law that rewards contributions to society by reducing a prison sentence. What do you get? Probably a net increase in corruption and irony.
First, the prisoner has a patent. Who owns it? - the prisoner. He made his own property. He has the right to exclude. He did not donate the invention to the public domain. Maybe they should have a credit system so that people who already have a patent can commit crimes and not even have to go to jail at all, while getting rich on their wonderful patents. Great idea. Wish I had thought of it.
Is the patent really worth anything? Patents have been issued like running water in China for some time, but many have little value; and are rarely enforced. I am not sure if the Chinese program includes the essentially unexamined Utility Model Patents.
The worst aspect (reminding me of bribery and test taking scandals to get IN to good schools) is the buying and selling of patents in order to qualify for getting OUT of jail with a reduced sentence. Let's see, commit fraud on the Chinese Patent Office, pay a crook for spoiled merchandise, commit fraud on the prison system, enjoy undeserved intellectual property, and get out of jail early for good behavior.
You know, it would be easy to catch these guys, if anyone (not bribed) made the slightest effort. If caught, they should spend extra years.
January 29, 2015
Counterfeit Cancer Drug Smuggler Sentenced
How low can you go? Fake Viagra is one thing, but what kind of person would take a few bucks to put a cancer patient's life at risk?
Good news is the U.S. supply chain includes relatively good chain of possession records to back track the bad guys. The real problem is the drug supply in developing nations where you can never be sure of what you are getting.
January 28, 2015
The Taste of Good Health
Another causation/correlation case. At least this one is not political.
Does the ability to taste umami cause good health?
January 27, 2015
The Solution to Batteries is Not a Solution, but a Dryness
Dry. Now I know why we lyophilized so many different drugs when I was a process engineer. Now, if I could only make my humor more dry.
What if we could gust get these batteries into a Tesla? Think how far we could go, and how long it would take to get there.
January 26, 2015
A Machine Proves Women are More Emotional!
Women are more emotional and more emotionally expressive. Who knew?
It seems strange this is the first time a researcher has used fMRI (functional magnetic resonance imaging) to demonstrate this difference.
Personally, I am a guy and, like other men, I am very much in control of my emotional expression and temper.
Army Gets the Lead Out, But Pays the Green to Be Green in Bullet Infringement Loss
More than just a lead slug. The infringed bullet has hard front and back ends connected with a weaker connecting material. The connecting material can be softer (like a copper alloy, but preferably not lead) to interact with the rifling in the weapon barrel. See:
On impact, the front and back sections split from each other. Not a Dum Dum, but fragmenting. There may be a void between the front and back to include various lethality enhancing substances.
The good news is the bullets replace soft lead with less toxic soft metal alloys. "Green" bullet because while lead has a specific gravity of 11.3 g/cm3, certain claims require less dense material. Funny, many claims state outcomes without defining the structures or materials.
It is amazing that very time I shot at a rabbit as a child (hunting at 11 in Montana), I left a couple grams of led in the environment. I could make any number of jokes, but I will leave it at that.
January 25, 2015
Did the Apple Camera Patent "Cause" the GoPro Stock Drop?
Here is another article with insightful comments about the GoPro stock drop.
The issued claims are very narrow and would be hard to actually infringe. It is not like Apple was granted a patent to small portable video camera, or something:
The stock drop may actually have been "caused" by the patent grant. (Although I thought the market was more sophisticated and could have followed the prosecution all along on PAIR.) The cause was psychological. The patent showed seriousness. The Figures show advanced designs.
How many times the size of GoPro is Apple? No one likes the thought of being squished.
Anyway, got to love these cameras. Now, I have a movie of me falling out of an airplane at 170 mph. How cool is that?
January 24, 2015
Super Complex Cars - The New Planned Obsolescence
What I find disturbing about new cars is a new system of planned obsolescence has been introduced, apparently unnoticed.
In the old days, cars were designed to fall apart (e.g., 120K miles max on an engine) in 10 years, so you had to buy a new one. That was before Japanese quality showed up and ruined everything for the non-competitive U.S. auto market.
Now, cars are extremely reliable. However, even with very high levels of quality and reliability, cars are again going to be basket cases when they reach 10 years of use. While my 1972 Datsun 240Z has maybe 10 systems (heat, wipers, radio, lights, gages, manual seat, mechanical window, interior lighting ...), new cars will have 100 systems. Even with a 1% failure rate per year, something will be breaking down every year (at first), only to increase with time.
I have a fairly modern truck I drive, when necessary. It thinks a door is ajar, when it is not. The dome light comes on when I get in and will not go off when I an trying to back up in the dark, then again does not go off for 10 minutes after I park it. Maybe I need a new $800 computer (which will not actually fix the problems).
I can only imagine how many unfixable parts there will be in current cars 40 years from now. Will there then be any fully functional 2015 "classics" in 2055?
All the systems work on my 240Z, except the computer I installed to replace my mechanical distributor points set (what is wrong with me?)
January 23, 2015
Milk Cows with Human Antibodies Against Ebola
Not as much of a fluff piece as I
expected from NBC News.
Holstein-Jersey cows with "fully humanized immune systems" are subjected to DNA vaccine against Ebola. I couldn't tell how many antigens were encoded. These cows are milk cows. I wonder if they would get any IgA?
Even is the serum is not a cure, I imagine it would at least help patients a little, especially if given early.
January 22, 2015
Loopy Complexes at the Heart of Chromatin Organization and Expression Control.
Well, I am caught unaware, again. I had never heard of these chromatin loops. What blows my mind is the huge number (billions) of nucleic acid (NA) sequence alignments and contacts that occur at any given time in a single cell. The amount of information in the contacts alone is incredible, much less the much more complex information being passed by NAs and proteins associated with each contact. The information passing in a single cell due to the loop phenomena alone seems to rival the information passing in a neural network (brain).
Although not mentioned in the article, of course, there are certain peptides facilitating the contact interactions of the NAs. For example, there is a CCCTC-Binding factor (CTCF, a Zn finger protein) in a complex with cohesin complex. Did I say COMPLEX. See a 2012 article on the subject:
January 21, 2015
Another Link Between Chronic Inflammation and Cancer
I guess the connection between inflammation and cancer has been has been on the radar screen for many years. I even remember a report years ago suggesting a connection between throat cancer and drinking carbonated water; you know that burning in your throat when you drink it too fast. Then, there are liver cancer with chronic HepC, cancer reductions with regular aspirin use, etc.
I also read another article recently where cancers were associated with excessive turn over (divisions) of cells, often caused by inflammation:
The interesting aspect of the current MIT article is the fact that the incidence of cancer is not increased much by acute inflammation because the DNA repair systems have a chance to clear damage. But, chronic inflammation leads to higher levels of oxidation and DNA damage. The damage is increased, and repairs less effective, in conditions where cells are dividing a lot.
So, moderation in all things. Avoid alkylating agents, take aspirin, and don't guzzle your Perrier.
January 20, 2015
Software Eligibility Overview in Light of Accumulated Court Cases
This is a good overview of the new guidelines and court cases around patent eligibility of software.
It may be a good strategy to present claims in a way that influences the subjective biases of readers to characterize the claims as directed to other than an algorithm. Thus avoiding rejection based on part one of the two-part analysis.
Ironically, one of the best ways to influence the part one analysis is by presenting claim elements in a way that passes part two analysis. Draft the claims so that they are narrow (not monopolizing humanity's heritage of the all powerful algorithm), adding physical elements that make the claim "more than" the algorithm. As a practical matter, it seems you may have to ultimately focus the claims on the specific embodiment you intend to practice in the market place to have a good chance of allowance and IPR validity.
January 19, 2015
Pole Dancer Takes on Martial Artist with Venum
This case makes some sense because a trademark registrant can not be totally sure of the timing and areas of use down the line.
Regarding the starting when to start the three year clock on nonuse of a mark constituting prima facie evidence of mark abandonment, it is nice to have precedent for an objective standard.
January 18, 2015
Bio/Pharma R&D Down in U.S Without Recession for Excuse.
Charts make more sense if you know they are normalized to 2012. So, Pharma/med R&D are up across the board, but not keeping up with inflation. Biotech is growing more than I expected.
With all the talk about how difficult grants are to obtain in recent years, I had expected NIH spending to be way down. Maybe it seems that way because there are more people filing for grants, or fewer people getting bigger grants?
China R&D investment growth was 17% over 7 years, to almost $10 billion; against the U.S. $117 billion. Much is made of the U.S. fall from 57% of the world total to 44%. Well it is easy for other giant countries to grow from 2% to 4%, but you can not grow from 57% to 114%. It will be great when other countries pay back the U.S. back by saving some of our lives with their new drugs.
Still the main message is not lost. Biotech spending should be increasing in the U.S. Some problems are that the media vilifies biotech (charging sick people money pills they need to live), foreign countries paying for manufacture but not R&D losses, the patent office now considers many hard found discoveries not to be patent eligible, and taxes and regulations make it easier to do research almost anywhere else.
See the actual JAMA article at:
January 17, 2015
Why Can't Most Big Corporations Innovate on a Big Scale?
On introduction, sales go only to the "innovator" purchasers; accounting to only 2.5% of the total product cycle sales. The article bemoans the fact that there is a time lag between innovators and the much larger group of "early adopters". The article does not mention that, for MOST products, the sequence stops at the innovators. At least some of the development losses are mitigated by the prices innovators are willing to pay for new stuff.
The only consistent way for big companies to grow in the long term is to not lose money on the average new product. They need to do lots of well managed small projects. Eventually, they will get a big ("blockbuster"?) product to go with the other one that made them big in the first place. The problem with a lot of mid to large-sized pharma companies is they get a big head and rest on their laurels (am I mixing metaphors?) thinking they can ride the first product forever, or that they are special and will soon come up with another big product. It Ain't Gunna Happen.
I suppose really big companies could run dozens of small well conceived projects intended to complement the over all business plan, with each project headed by a Director or VP with skin in the game. Then, on the average, there could be incremental small successes that provide good growth. Who does this? Instead, most large pharma corporations just look around and buy the successes of others (whether they are a good fit or not).
Lucky can make a small company a success, but not a large company. Big companies can afford to buy success, but not by going on a buying spree. They have to wait for opportunities to buy perfect fit small companies with market values far below the value added to the big company. Too bad most large companies do not seem to be good at waiting or fitting.
January 16, 2015
USPTO Program to Delay Missing Parts Expenses is Extended
It is pretty rare I have a client needing another twelve months to decide if they want to go through with conversion of their Provisional application to a Utility application. Where this would be more valuable is if they could put off the much higher Patent Cooperation Treaty (PCT) fees a while longer.
January 15, 2015
Complicated Cancer Treatment. But, Heck, If bDNA Can Work, Anything Can
Boy, this seems too complicated. OK, toxins with ligands directed to cancer cell targets. Stem cells (not sure the advantage over non-stem cells - but they are the cells on all our lips!) in protective capsules secreting the toxins, which diffuse through the capsules. Implantation near the cancer cells. All in a day's work.
What could go wrong? Immortal cells. Pluripotential - what will they differentiate into? I suppose the capsules are biodegradable. Hmmm. Maybe I should read the journal article.
Sorry, I am usually a cheer leader, but not today. I just put a computer in my 42 year old car to run the previously mechanical ignition system, and it is giving me no end of trouble. Too complicated.
January 14, 2015
Big Spike in Drug Approvals.
Is it a trend?
This is great news and long in coming. The drug business has been getting over ripe. Didn't I read the other day that only about 10% of drug sales are not generic?
Not to be sour grapes, but these approvals have long lead times and reflect conditions some 5 years ago. Hopefully the bad press to pharma, difficult new challenges in patenting biologics, likelihood of increased government (foreign and domestic) interference in the market, and the greater competition for key markets will not blunt this trend of increased approvals.
January 13, 2015
Diversity in Cloned Stem Cells Influences Implantation Results
I had been wondering about so called somatic stem cells. There has been some media suggesting that they were all so wonderfully pluripotent. However, from my embryology courses, I had a gut feeling that it would not be so easy, e.g., to force a stem cell from a mesoderm-derived tissue to differentiate into cells of a tissue normally derived from ectoderm.
This review by Hart (J. Biomedical Science and Engineering, 2014, 7, 526-532) gives a great overview of issues, but asks more questions it answers. Mesenchymal stem/progenitor cells (MSC/MPC) were found to vary in multi-lineage differentiation potential. Standard characterization of stem cell clones by surface antigens failed to identify the diversity of the clones derived from adult tissues.
Consistent stem cell harvests were difficult to obtain (making clinical use unpredictable). Variants may be due to age, sex, genetics, environmental factors (inflammation, nutrition, stress), replicative senescense, and epigenetics. Stem cells may be influenced by mircoenvironments within the same tissues where they are harvested or implanted. In any case, different batches of stem cells seem biased toward different differentiation results, based on unidentified factors.
I was very skeptical of a recent article concerning preparation and implantation of "fat stem cells" to treat any number of pathologies, e.g., including Parkinson's, MS, MD , and Alzheimer's. See: http://health-innovations.org/2015/01/02/scientists-identify-new-immune-response-via-human-fat-cells/ Other research has shown that only a very small percentage of implanted stem cells eventually reside at the intended cite and differentiate as members of a damaged tissue. The fate of the rest of the cells remains unclear.
In another rather crude experiment, a spinal cord damaged patient received nasal tissue thought to contain neural stem cells. Although some neurons with fibers did grow in the injury site, they did not integrate functionally. Meanwhile, mucus cells also seemed to reside and produce their excretions. See: http://www.newscientist.com/article/dn25859-stem-cell-treatment-causes-nasal-growth-in-womans-back.html#.VLFjvivF98E
Implantation of diverse stem cells could actually provide a better result by providing multiple cells types necessary in normal tissue. However, what do you think the risks could be to implanting stem cells that are not fully characterized?
January 12, 2015
Higher Maintenance Fees Tend to Prompt Lapse of Lower Quality Patents. Imagine That.
No surprises here. With higher maintenance fees, patents rated lower in parameters thought associated with quality patents tend to be dropped, while higher quality patents are retained.
Patents held by owners with large patent portfolios tend to be higher quality. Large portfolios also tend to drop fewer than lower rated patents. I suppose single patent holders have less money and less experience marketing their inventions, so are more likely to allow lapse of their patents, regardless of quality.
January 11, 2015
New Family of Super Antibiotics? Teixobactin Against Peptidoglycan Formation
I saw in the general U.S. news media that there was a antibiotic family that does not prompt resistance which kills famous super bugs. So I went to BBC and got a bit more real information.
Well, it is nice to have a new family of antibiotic. You may be able to view the Nature article at:
The technique of cultivating bacterial in their own natural environment is not so new:
Anyway, teixobactin was isolated from Eleftheria terrae and is apparently a strong inhibitor of peptidoglycan formation (best against gram positive bacteria) with good pharmacokinetics. Teixobactin binds to several targets, none of which is a peptide, so resistance may not be easy to evolve. Even if it is not as good ay hyped, it may well be a good starting point for modification and improvement.
January 10, 2015
Far and Away Most Cancers Due to Random Mutation in Stem Cells, Not Environmental Factors
So, colon cancer is just a c**p game. Sorry. Couldn't resist.
The correlation coefficient is very high between published stem cell turn over rates in tissues and rate of cancers in those tissues. I bet even many environmental causes of cancer are merely due to stem cell turn over due to irritation from the environment (smoking, asbestos, sun).
That being the case, the author is right that efforts might be better spent on early cancer detection than fighting environmental or life style causes.
Makes you wonder if lives saved avoiding pesticide residues on fruits and vegetables to avoid cancer are more than made up by death from obesity in those that eat fries instead.
January 9, 2015
PTAB Claim Amendment Standards Require Disclosure of "Known" Universe
The patent owner "is expected to reveal its relevant knowledge." Known art. That is a small universe. At least they are not expected to do a search and prove a negative. This standard for PTAB proceedings amendment seems the same as regular prosecution.
The same for written support. I always provide a description of where to find support for any amendments during prosecution. Otherwise, the Examiner may object; sometimes without actually looking for himself.
Not sure what is up with this requirement that the patent owner must identify written description support for the entirety of a substitute claim in the original disclosure, not the issued patent specification. Does this refer to the rare amendments to the specification, e.g., identifying material incorporated by reference, or describing in text what is in the figures?
Over all, the TPAB standards seem pretty usual, and maybe generous, considering they are allowing amendments in a post prosecution proceeding.
January 8, 2015
What Information Does a "GMO" Label Provide?
On the news yesterday I heard a politician suggest that everyone has a right to know if a product is GMO, and there ought to be labels. In the next breath he admitted that almost no one knows what a GMO is. In any case, he said, until GMOs are proven safe, there ought to be a label.
I am all for information availability, but the information should be useful. If everyone is afraid of GMOs (e.g., frankenfood) without a reason, what good is a simple "GMO" label? Maybe it would be better to label GMO products like any other products. That is, where there is a known hazard, e.g., allergen (peanuts), toxin (cigarettes), health issue (hydrogenated oils), it should be on the label, case by case.
I see little chance the general public will ever understand GMOs generally. Where there is a significant issue with a GMO product specifically, the media and pundits can raise the issues (e.g., on Good Morning America) and get the specific useful information out so consumers can make an informed choice.
January 7, 2015
Difficult Times Still Ahead for Patent Enforcement and Litigation in 2015?
I like this well written prediction of trends in patents and patent litigation for 2015.
Thank god my law firm is not heavy into patent litigation. Litigation is already way down due to the inter partes review (IPR) options, and reduced expectations of enforceability for patents written in a different era. It will only get worse if the fee shifting legislation takes hold in 2015.
I have to say, I think that fee shifting and simpler dispute resolution (i.e., IPR) are generally a good thing. The negative aspect of these changes is the attitude of politicians and media that may go too far and harm, e.g., non practicing entities (NPRs), or even harm practicing patentees trying to diligently protect their valid intellectual property.
From the point of view of patent prosecution, the news could be good for firms that draft quality applications and strongly argue legitimate points during patent prosecution. The best defense against the post-grant hazards should be a broadly supportive specification, a patent prosecution history, and indisputable claims.
January 6, 2015
CAMP Kills Microbes in Skin
Well, for starters, they might have given the antimicrobial peptide a different acromyn than CAMP. Naming a molecule in biology is getting like trying to find a name for a trademark or ID in Google mail. Now, how is cyclic adenosine monophosphate killing bacteria?
Anyway, it appears that fat (stem?) cells secrete cathelicidin antimicrobial peptide or CAMP in the presence of bacteria. CAMP is apparently a part of the innate immune system that can destroy the lipoprotein membranes of microbes. Historically, this was shown to take place in phagosomes containing bacteria after fusion with lysosomes in macrophages. Here, the fat cell CAMP is apparently secreted on contact with bacteria. I assume there is also a pathway wherein the presence of this CAMP calls immune cells to the site.
Obese subjects have been observed to have more CAMP in their blood than subjects of normal weight. Although obese patients are more sensitive to Staph infections.
It has been suggested that the diverse family of CAMP peptides should be reviewed as a source of potential "antibiotics". Call me an old grump, but I have a gut feeling that CAMPs are not generally highly potent, and may produce side effects when taken out of their normal balance.
January 5, 2015
January 5, 2015
Cellulose/Lignin Construction not a Path, but a Thicket
How can we get that nasty ole lignin out of the way so wood can be used to make biofuel?
Well, I guess this is a breakthrough in understanding of how cellulose and lignin production is moderated in plant cells. The less good news is that the network of protein/DNA interactions is extremely complicated and unlikely to be disentangled any time soon.
See figures from the article at:
January 4, 2015
Peptide Synthesis by Quality Control Protein in Cells
The protein in need of repair is not shown in the figure presented, so guessing the interactions is difficult. And, is the mRNA already released?
I believe we have a subscription to Science in my office. I will look into this further.
I had thought such faulty proteins usually went about their inefficient business, or were destroyed by quality control proteases. This is the first I have heard of a system attempting adjustments to a protein in the process of translation.
The author raises issues around disease states in neurology (CJD does come to mind as relevant). Seems errors in other master signaling proteins, and such could also be to blame for other disease states.
Anyway, the diversity of information control in cells never ceases to amaze me.
January 2, 2015
Generics Lined Up to sell Viagra Everywhere But U.S.
Apparently, Viagra (sildenafil) was patented by Pfizer in 2002, and the composition patent expired in 2012. Initially, the indications were hypertension.
Pfizer retains a patent US6469012 (https://www.google.com/patents/US6469012?dq=6469012&hl=en&sa=X&ei=zW2kVPr0EeOr7AbSv4HoCg&ved=0CB8Q6AEwAA) for methods of ED treatment. So, even if you get Viagra prescribed to treat your hypertension, you are infringing if it also cures your erectile dysfunction (though you do not want to know how Pfeizer is going to find out).
Does anyone know about the court case that apparently extended the methods of treatment patent term?
See more information at:
http://www.accessrx.com/research/viagra-patent-expires/ method of treatment ED
January 1, 2015
Disney Sued for Frozen Plot
What goes 'round comes around. Disney seems to stretch their copyright infringement accusations too.
I suppose the Snowman makers are now enjoying some additional press and may get a small settlement (or a huge legal bill).
Generic Drug Prices Jacked Up?
What the article apparently fails to mention is why the price of the listed generic drugs can sky rocket.
I have seen reports for some generic drugs where the price got so low, all manufacturers but one got out of the market. Then, the remaining manufacturer jacked up the price. I assume that the high priced generics are almost exclusively for drugs with only one manufacturer. And I assume (and hope) that new manufacturers will enter these markets and force prices down some.
However, we know the cost leaving is low and the cost of entry is high in drug manufacturing.
December 31, 2014
Rampamycin Does It All - Longer Life Anyone?
Wow, Rapamycin does it all. Is this the next aspirin?
Rapamycin was initially discovered as a antifungal compound produced by a Streptomyces species on Easter Island. How cool is that? Then, they discovered that it has immunosuppressive effects in humans. Have to be careful, because the immunosuppression is associated with increased chances of certain cancers.
But wait, in mice it apparently reduces certain common cancers and extends their life span, though it apparently does not inhibit most signs of ageing. Rapamycin influences SLE and muscular dystrophy. Spread it on a stent to prevent restenosis.
Also see 2013 article:
December 30, 2014
Nucleic Acid Cross-Linking Reduces Pathogens and GVH in Platelets
I recently read an article (http://www.drugs.com/news/fda-approves-first-pathogen-reduction-plasma-54304.html) wherein UV activated DNA cross-linking was used to inactivate pathogens in plasma. No reason it should not work in the clean up of platelets, which have no nucleus.
Still, I have questions. "The platelets are then purified to remove the chemical and its byproducts." If the chemical (psoralen derivative?) is cross-linking nucleic acids (e.g., in a virus, bacteria, white cell, or even the RNA in the platelet cytoplasm) how can it be removed?
OK. I looked into it further. See, e.g., http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3132977/
The psoralen derivative amotosalen is adsorbed with a "compound adsorption device" (CAD). No article appears to actually discuss the nature of the CAD. For example, what is the nature of the ligand binding the amotosalen. Seems unlikely that it would be able to bind cross-linked nucleic acids inside cells.
In any case, the maker (Intercept) reports no cancers caused by their technology. They report no toxicity, even at 1000X the clinically used levels of the amotosalen, e.g., even if the blood product is not depleted with the CAD system.
I would still like to find out more about how this system works.
December 29, 2014
Here Come Fat Stem Cells to Save the Day
I do not have all the facts, but the "infusion" of expanded "stem cells" from fat for a fee does not seem ethical or legal, in many cases.
Expansion of stem cells from fat probably is a significant modification because of the expansion and likely change in the character of the cells. Infusion back into the patient should probably be considered an implant of a medical device, subject to FDA rules.
Fat is mesoderm origin. I am not sure what disease state could be cured by "IV drip" of fat stem cells. Certainly not MS or Parkinson's. Where would you inject for MS? Wouldn't the cells have to be at least partly differentiated and injected into the brain to treat Parkinson's?
I hope someone is at least collecting data on these chaotic experiments. As far as I am concerned, fully informed desperate people should have options. But maybe they should not be charged until data show safety and efficacy for their particular indication.
December 28, 2014
Would the Price of Chinese "Import Substitution" be Isolation?
"Import Substitution" has not worked for China in the past, or for anyone.
I was in India in the old days, when they practiced import substitution and protection of internal business. Everything was expensive junk.
A strategy of expanded trade secrets and import substitution might work in China, in the short run. When the government runs everything, who needs patents? Trade secrets would work as well in many cases. The Chinese government can control who uses what technologies and trade secrets internally, without worrying about reciprocity when it comes to foreign patent enforcement.
I do not see things going that way, though. The present system has been working well for the Chinese, now that they have inventions of their own needing protection around the world. Further, lack of reciprocity and manipulation of markets may lead WTO trade disputes.
The main reason I do not see China going too far down the path of import substitution is that the isolation may waste energy generating products not suitable for the export market. Why do you think they bought IBM? If they spend too much time reinventing the wheel and producing incompatible technologies, they may kill the golden export goose that has drug them out of the 19th century.
December 26, 2014
India Court Sides with Novatris in Onbrez Patent and TM cases.
The fact that Cipla intentionally mimicked the Onbrez trademark shows they have an adversarial attitude and act in bad faith.
Then, Cipla apparently filed for compulsory licensing without any attempt to obtain negotiated licensing.
Don't these guys (Cipla) obey any rules?
Good the India Court has followed their own rules and played no politics in this case. Still, if Novartis is not practicing the technology of the drug in India, they might be wise to negotiate a rate reflecting Indian demand and resources.
December 21, 2014
"Comprising" is an Open Ended Universe. Don't Suggest it is an Unduly Difficult Universe.
Promega claims required products to include all three loci. The claims were rejected for alleged lack of enablement for products comprising the three loci Plus Additional Loci.
According to the Court's logic, Promega could have claimed products "consisting of" the three loci, but could not claim products having the three loci plus one unidentified loci. Hopefully, the PTO will not take this a generic holding and deem that no "comprising" claims are enabled, only "consisting of" claims. .
An important fact here is that Promega represented to the Patent Office that the addition of even a single locus to an existing loci combination rendered that new loci combination
How could they have claimed more than just the array reduced to practice? Maybe avoid the word "comprising" with "including"? Maybe not stating in the specification that additional loci are difficult to practice. Maybe by ensuring that the specification teaches a generic method of identifying additional loci.
December 20, 2014
Can PTO Give What They Do Not Own? New 101 Guidelines
I had always argued that new combinations of two or more natural substances should be patent eligible (contrary to the now discontinued [discredited?] gun powder example).
There is also the news that claims that do not tie up a natural substance should be subject to streamlined review. And, where there are two or more natural phenomenon, it seems that facts show one is eligible, the Examiner does not have to go on to the next (we shall see). Among the variety of new Guideline options, Biotech seems to now have a stronger position.
But, the PTO does not Legislate, and Judicial case law trumps, so get ready to argue facts applied to closest case law (if Examiners even know what that is).
December 19, 2014
More Data May Enable Broader Monoclonal Antibody Claims
Fascinating discussion of combined antibody and protein conformation definition to provide advantageous "edges and angles" in peptide engineering.
This is very important from the point of view of patenting peptides and interactions. Even though a protein engineer could modify a protein (even an antibody variable region) with the expectation of retaining (or even improving) binding affinity, most patent offices around the world have long limited most antibody claims to a very specific set of 6 CDR sequences.
Because Dr. Lawson, and UCB (apparently not one of my clients - UC Berkeley) Pharma, can present so much specific data on protein/protein and antibody/epitope interactions, they can be justified in obtaining antibody patents of broader scope! The Examiners brush off my enablement arguments based on Goa's work (e.g., Human Mutation, 30 (8),1161–1166, 2009).
Finally, a way to "persuade" an Examiner away from the unique sequence dogma that has settled into the antibody patent prosecution.
December 18, 2014
Technology to Reduce Pathogens in Plasma
Amotosalen is a psoralen compound that cross links nucleic acids in the presence of ultraviolet light. Plasma for injection into patients is exposed to the chemical and ultraviolet light. Then the Amosalen is removed. Does anyone know the method of removal (and does the method also remove the crosslinked nucleic acids)?
The clinical study showed no additional adverse effects of using Amotosalen to reduce viral loads in plasma. However, the chemical only reduces and is not guaranteed to eliminate pathogens. I did not see any data showing a reduction of transmitted blood born diseases.
See Intercept corp product description at:
December 17, 2014
New Patent Office Patentable Subject Matter Guidelines Really are New.
Well, this is a surprisingly exhaustive reconstruction of the patentable subject matter Guidelines for the Patent Office.
There is one simple block flow diagram controlling analysis for both process and products. See it early in the document.
Look up "streamlined" review (Part I.3.) wherein if the claim "clearly does not seek to tie up any judicial exception such that others cannot practice it. Such claims do not need to proceed through the full analysis ..." That is, if the claims do not tie up a substantial range of used for the natural product, the Examiner does not have to go on to see if the claim is "directed to" the natural product and to see if "additional elements amount to significantly more" the judicial exception (e.g., natural product or mental process). There is some logic in this (imagine this at the PTO). If a natural phenomenon is not tied up by the claim, there must be significantly more to the claim. This opens up better arguments for some of my cases, where the bulk of uses for the natural product are not within the scope of my applicant's claims.
The Examples section of the Guidelines essentially sticks to descriptions of controlling case law. Gone is the example where gunpowder was considered a natural product. If the claim includes several natural products, only one natural product need be reviewed. If the combination with other natural products adds significantly more [or narrow the claim so the first natural product is not "tied up"?] subject matter should be considered patent eligible.
Again, the Guidelines reiterate that the Examiner must still do a full analysis of novelty, obviousness, enablement, etc. I have had some first Office Actions lately with only a section 101 subject matter rejection. I got the feeling the lame 101 rejection was just a way for the Examiner to avoid the work of actually examining the application, while still getting his/her points.
Overall, it appears the Patent Office has become a little more rational, and maybe fair. We will see how the new Guidelines are implemented.
December 16, 2014
How Can We Avoid Wars of Attrition with Patent Ogres?
The reason a bully on a school ground is willing to push littler kids around is he knows he will only be hurt 1/10 as much in a fight as the littler kid. And, the fight will never happen.
Regarding patent ogres, the case is the same. With the current legal system, I see no solution to motivate big businesses not to behave as ogres. Even if you make them pay the little guy's fees, should the ogre lose, the ogre still has relatively minor injuries. And, more often than not, the guilty ogre is never shown to be guilty, because the case "settles" or the small guy runs out of money before a verdict.
There is one direct way to make the litigation as painful to the ogre as the small guy (and I do not support it as a first step). Remember that law in Sweden that hands out speeding tickets in proportion to the wealth of the speeder? The speeding ticket is assessed according to the wealth of the speeder. A poor speeder with a wealth of $10k is fined, e.g., 1% of wealth- $100. A rich speeder with a wealth of $10 million is fined $100k for the same offense.
What are the problems with such a system? Well, first of all, who would get the money, and what perverse incentives would it spawn? We could probably get the government to write such a law, if the fines went into general tax revenues. If the little guy got the money, what productive actions would they take with the windfall? Because big companies have a much higher level of exposure, wouldn't they be swarmed with many small guys, perhaps leading to their destruction?
Another analogy. In nature, a grizzly bear will not tussle with a badger, even though the bear has a 20x size advantage. The bear could eat the badger, but has a significant chance of receiving a substantial wound. When the bear and badger come across each other, there is a lot of posturing, while they size each other up. If the facts show that the badger is in a good position, e.g., defended in his den entrance, the bear will decide it is not worth it to attack.
How can we apply this to the world of big and small IP parties? The parties should be provided a good way to present the real facts for a simple resolution, followed with the significant chance of harm to the party that ignores the facts.
It seems the only way for fair resolution, that does not become an unbalanced battle of attrition, would be to have a two phased justice system. The first part of the system would be simple and inexpensive. The two parties would be required to present up front FACT BASED arguments supporting their position. This could work, e.g., where the infringement is to a device patent where discovery could be as simple as examining an allegedly infringing gadget. If a party lost the simple case, and wanted to move on to an Appeal, then, maybe they could be subject to fines proportional to their worth. Hmmm....
December 14, 2014
Who Does Not Need a Patent?
I agree that patents are more important for biotech and medical devices than for high tech inventions.
Who does not need a patent? About half the time I advise small unsophisticated clients that a patent would probably not be cost effective for them. They are often starry eyed and need a reality check on the time and costs of patenting and marketing an idea. Or ... their idea is not new.
Regarding early stage companies, I differ with the statement that "early stage companies pay three times more" than larger corporations. I could not find such data in the linked report (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1429049). With my early stage cost consciousness of start up clients, we often find ways to reduce costs and focus on early priorities. I often provide low cost or free advice, to help them get started and build a relationship. I imagine other firms do this, but maybe not.
December 12, 2014
Court Orders Maker to Continue Sales of Alzheimer's Drug Near Patent Expiration
I believe the patent on the original Namenda Alzheimer's drug will expire next year. Namenda XL is a one dose extended release form with more years left on the patent.
maker is trying to force all patients to switch to the XL dosage before the original patent expires. My understanding is they are trying to accomplish this by ending sales of the original patent expires and generics have not yet started sales. By the time the patent expires Actavis (the maker) will have retained their full market share and patients would have an administrative burden of switching to generics.
Seems pretty manipulative. The New York Attorney General has sued based on anittrust allegations.
December 10, 2014
China's Patent Filing Great Leap Forward.
I have seen fragments of this data before, but Reuters has put it all together.
I had seen that China filed more patents than anyone else, but thought many must be those low quality "utility Model" patents. Nope, they file more Invention patents requiring strict review in prosecution. Still, there must be something not quite right, considering the very low number of CN patents filed in other countries. If they were valuable, wouldn't they file outside?
The rate of filing CN to JP is very low, while the filing from JP to CN is high. Any ideas why with is? Lots of foreigners (US and JP) file in CN, even though they are not selling much there - trying to reduce manufacture for export from CN?
It caught my eye that China files far more (world dominant) patents in the field of alkaloids and plant extracts. Two comments: 1) they mention this is mostly China claiming their 2000 years of medicines have been IN USE for more than two thousand years (hmmm), and 2) why waste your time with these "inventions" in the USA where many would be ineligible subject matter under section 101
Forward citations of patents by later applications is very low in Asia. Probably due to language issues. It is 5 times higher in the U.S.
December 9, 2014
3D Printed Fuel Cells - Well, at Least the Inks
I can readily imagine how they make anodes and cathodes. Even, how they could use emulsions or localized drying to get the porosity for adequate surface areas.
I am not sure how they would prepare the necessary proton permeable membranes with adequate exchange rates. I can't find a patent application for this. I wonder when the details will be published.
December 8, 2014
Patenting is as Easy as Falling Off a Log
We have seen other data lately, but I can not remember. It seems some sectors (communications?) make up a far higher proportion of the patent issue increase than others.
Considering the amount of subject matter rejections, post grant review problems, and discouraging Court cases recently, I suppose this log chart may go sigmoid soon.
December 7, 2014
CFF Charity Sells Out Royalties on Ivacaftor for $3.3 Billion
Wow. $3.3 Billion is a lot of money for a drug Ivacaftor with indications for only 5% of cystic fibrosis cases.
The Cystic Fibrosis Foundation must have been collecting huge royalties on the drug, for Vertex to sell them out for this amount.
Remember Vertex was being run through the mill for the price charged for this drug? Why was the media so silent about the fact that a big chunk of that money was going to CFF?
December 6, 2014
Previously Secret PTO Policy to Prevent Embarrassment Delays Pioneering Patents
Self centered government out of control again, forgetting they less important than the People.
The stated policy reasons for the program are pretty bad. http://hho4free.com/documents/patent_screening_uspto%20memo.pdf Your application may be sidelined in a Patent Office defensive committee limbo for years if - your case is deemed "controversial or noteworthy", if it may "generate unfavorable publicity" for the PTO, or if you have an "application with pioneering scope".
If these are the motives they were willing to put into writing, what are the unstated motives?
Sometimes Applicants are paranoid, and sometimes the Man really is out to get them. Heaven forbid if you have a breakthrough pioneering invention.
How could they have done this differently?
December 4, 2014
Just In! Red Wine May Reduce Cancer and Mediterranean Diet Extends Telomeres!
Old news, but fun to hear it confirmed again. Mechanisms may be unfolding in continued research.
Too bad I drink beer with my Med diet.
December 3, 2014
HIV Strains Trending Toward Less Virulent Forms in Response to Selective Pressures
This is not the kind of data I expect to see in the normal course of a lifetime. Most evolution of pathogen populations and host populations takes place over hundreds of years. Here, we have the fast evolving HIV and the intense selective pressures exerted by human behavior and the pharmaceutical industry.
Actually, recent data suggest HIV originally jumped into human hosts a hundred years ago from primates. On introduction, there was no balance and HIV has been unusually lethal and tenacious. However, eventually the interactions of host and pathogen should normally reach a balance where the virus may be more successful. Extremely virulent pathogens are typically not very successful. HIV may have started out too virulent and is trending toward less virulence in humans.
See the full article at:
At first the theory seemed a little flakey to me. Why would adoption of HIV to more resistant hosts be an advantage, unless the initial compliant hosts were being killed off? Why would the reduction of viral load from antiretroviral therapy select for Less virulent HIV strains?
Well, it is true if the host lives longer, more transmission can take place. And, some of the retroviral drugs act only against active viruses, so the less aggressive HIV may be selected (much the same as with some antibiotics and cancer drugs.).
So, when will we come into
balance with a less aggressive form of HIV? I doubt a balance will ever be
reached, in the "Natural" course of things. New drugs will change
selective pressures. New treatments, such as a Therapeutic Virus (Looking
for research and development partner (US 20140030792 :
December 2, 2014
Joint Ownership and Inventorship Complications in Patent Rights
All these problems in the article can be avoided with proper contracts - Assignments, collaboration agreements, and joint development agreements.
Without clear and valid inventorship and preexisting agreements, joint ownership can lead to any number of problems, particularly with unsophisticated "inventors". For most of my clients, all named inventors have assigned their rights to a common entity (their employer) - a school or corporation). This avoids the problems stated in the article.
However, here are a few problems I have seen regarding inventors and owners:
Applications with inventors added with no actual inventive contribution. Hot shots that paid for some of the work, or who want another entry in their resume. This has to be correct by the time of issuance. If inventorship is intentionally incorrect, it may be considered inequitable conduct on the Patent Office and the whole patent can be invalidated.
Collaborations between contracting entities where the staff of one entity did not actually contribute to the claims that issue. Just because ownership is designated by contract, does not mean the application can list improper inventors. I have had to provide an inventorship analysis in such cases, even though it was immaterial to ownership of the patent.
One instance that particularly bugs me is a small inventor who had discussions with a large entity before filing an application. The large entity staff claim to be inventors of the present claims (even though the claims are outside their area of expertise) and have insisted on listing the large entity as an owner Applicant. Meanwhile, they feign no interest and will not contribute to prosecution costs. Again, inventorship (controlling ownership since there is no contract) must be verified when allowable claims are identified. Inventorship analysis is not free, and this will be a burden on the small inventor.
Inventorship determinations can change joint ownership rights. Don't let ownership get out of your control, or you may be subject to the problems identified in the article, and more.
November 29, 2014
Big Pharma Dropping Off Patent Cliff
Pipelines. Not oil, but drugs. Just because they certain pharmaceutical companies are big, does not mean they are lucky. Research runs at least 50% on serendipity. Throwing huge amounts of money into research does not guarantee the next blockbuster. I believe that lately big pharma research expenditures have not even kept up with inflation. Often, it is easier for them to spend $100 million on a startup with a phase I drug candidate than to spend $200 million trying to find a candidate from scratch. This is good news for well directed small companies
A big lesson from the article is that big and small pharma rely almost exclusively on patent position to as a basis for their valuation and to assure compensation in the marketplace. Small pharma, without even a net profit, is not going to be bought out for $100 million without their patent portfolio in place.
Another lesson is that patents do run out. After 5 to 10 years developing a drug, a pharmaceutical company may have only 10 years of sales to recoup the research and development expenses. Because of this, pharma does not have the profit margin the cynics imagine. http://yourbusiness.azcentral.com/average-profit-margin-pharmaceuticals-20671.html. Even the often quoted profit margin of about 12% is cherry picked data - not including the widespread negative burn rate of struggling small pharma start ups.
Eventually the hard work and creativity of the researchers become a gift to society (and generics manufacturers. THANKS.
November 27, 2014
Parasitic Worms Send Calming miRNA Messages to Host Immune Cells Using Exosomes
Every few months I hear more exciting news about miRNA functions. Here is a copy of the full article:
Apparently, the gastrointestinal nematode parasite (Heligmosomoides polygyrus) incorporates miRNAs into vesicles (exosomes) derived from host membranes to assemble a Trojan horse for entry into host immune system cells. The miRNAs are homologues to mammal host miRNAs controlling immune responses so they can send a false signal local immune cells not to attack. The exosomes fuse and discharge contents through non-specific membrane fusions not requiring peptide interactions. Such a simple way to avoid host immune responses. What other pathogens use similar strategies?
The authors enriched parasite-derived exosomes by centrifugation and applied them intranasally to mice. Then, when the mice were exposed to inflamatory Alternaria mold extract the normal eosinophilia was sharply reduced. A treatment for allergies or asthma?
November 25, 2014
University OTTs - Trolls or Just NPEs?
Even the most successful university technology transfer office (OTT) does no better than $2 for $1 spent administering the portfolio. The data are incomplete ( http://www.insidepolitics.org/brookingsreports/University_Tech_Transfer.pdf ), but I suspect many OTTs barely pay their way. Of course, the $2.5 billion received by OTTs will never make a big dent in the $90 billion the Feds spend on academic research, but that is not the point.
Some say it would be a good idea to find grants based on patents issued instead of on journal articles published. Sorry to say, funding based on patents granted would probably increase the number of patents with worthless claims. At least with a publication, some independent journal (maybe not a Chinese journal, but that is a different story) found value and prestige in the article.
I believe the real success story is when university scientists exercise their option to practice their inventions (where the university has found no licensee) and they start new businesses.
Trolls? Not universities. NPEs (Non-Practicing Entities). I do not think there are many examples of universities suing companies just to settle for the value of avoiding litigation. More pointedly, most universities do not have the assets to win a battle of attrition in the Federal Courts.
November 21, 2014
Who Needs Bone Marrow Stem Cells When You Have Nails?
Interestingly, after loss of a nail (e.g., due to trauma; raise your hand if this has happened to you), the shift between skin and nail production is signaled by bone morphogenetic proteins (BMPs). At first I found this surprising because skin and nail are ectoderm origin, and bone mesoderm. However, come to find BMPs are a family of growth factors than can influence tissue architecture throughout the body.
BMPs are available clinically, e.g., to aid in healing of spinal fusions and oral surgery. Apparently, certain members of the BMP family can be purchased for off label use (80% are sold off label), even over the counter. The negative side effects of these usages are not well understood. I wonder if they give you thicker more luxurious nails?
University of Southern California - Health Sciences. "Nail stem cells prove more versatile than press-ons." ScienceDaily. ScienceDaily, 21 November 2014.
November 19, 2014
Bioequivalence Testing Continues After Marketing to Identify Statistically Different Generics
Here are some administrative processes I was not familiar with in the field of small molecule generic drugs. Generic copies of a drug against attention deficit hyperactivity disorder (ADHD) are suspected of not being bioequivalent. The FDA has put them on probation, of sorts. The therapeutic equivalence (TE) rating for two generic products were changed from AB to BX, allowing continued subscription, but not with equivalent status required by most pharmacies and insurance carriers. See - http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm .
Apparently, the extended release of the generics is different. The generic makers have 6 months to confirm bioequivalence, or exit the market. Manufacturing a copy delayed release may not be as simple as formulating to a similar in vitro stir dissolution assay.
November 18, 2014
Turmeric - The Solution to All Problems
I wrote a patent application concerning use of turmeric extracts in wound healing when I first started doing patent prosecution. Ever since, I can't help but notice all the benefits it is said to bestow (it's like not noticing how many VW cars there are until after you own one).
Here, turmeric in the morning provides better working memory to pre-diabetics in the afternoon.
No proposed mechanism is suggested. Let's see, curcumin reduces oxidative the cholinergic neurotransmitters (http://www.ncbi.nlm.nih.gov/pubmed/19221412 ). Or, how 'bout this - turmeric reduces blood glucose levels? (http://www.emaxhealth.com/1275/turmeric-improves-blood-glucose-type-2-diabetes ) Hey, wait a minute, doesn't the brain need glucose to think? But, not if there is too much glucose. (http://www.medicalnewstoday.com/articles/267727.php ).
Who says you have to do research to solve problems? In any case, you CAN solve all problems with turmeric. Just don't spill any on your kitchen floor; you will never get the yellow stain out.
November 17, 2014
Do You Want Super Sized Acrylamide with Your Fries?
Even though the genetically modified potato would be healthier and suffer less spoilage, McDonalds refuses them based not on science, but the negative media atmosphere generated by the politically and emotionally (paranoid) driven press. I guess they prefer neurological symptoms, decreased fertility, and cancer.
See the application Low Acrylamide Foods: https://www.google.com/patents/EP1974039B1?cl=en&dq=acrylamide+inassignee:simplot&hl=en&sa=X&ei=4HhpVLnjB46fyASQpoC4Cw&ved=0CEkQ6AEwBg
Asparagine and reducing react in the presence of heat to form acrylamide (neurotoxin familiar to lab technicians that used to pour their own gels for polyacrylamide gel electrophoresis (PAGE)). The constructs inserted into the potato down-regulate expression of asparagine synthetase genes or up-regulated asparaginase to reduce asparagine in the starchy tissues. The result is a food plant with no unnatural nutritional elements, but reduced in free asparagine amino acid.
Seems a little snooty for those selling or eating a salty oily food, famous as a source of the obesity epidemic, to turn up their noses at a safer product. I was going to say they get what they deserve, but actually - shame of the ignorant media.
November 16, 2014
Crazy Combination of Microfluidics, FRET/Fat FACS Identified Pathogen Bacteria in Microliter Blood Samples
A cool combination of some old tricks. A bit of a fluorescent resonance energy transfer (FRET) probe, with some nice diluting water in oil microfluidics, read in a fat fluorescence-activated cell sorting (FACS) that passes by the detector in a vortex to read batches of particles at once, instead of waiting for them to pass by one at a time.
I think the most interesting part is the DNAzyme construct that sets up the FRET detection for specific bacteria of interest. The DNAzyme constructs can have different probe sequences triggering different fluorescence wavelengths so that several different bacteria can be screened in the same assay. See details at:
This is a great idea, whose time has come. I get tired of waiting around for culture plate pathogen identification. So too are the doctors who often skip culture entirely and just make a guess as to the most likely pathogen.
November 14, 2014
Even "Reasonable" Little Guys Can Get Hurt in "Loser Pays"
The big guys are essentially self insured, and the little guys have no insurance. That is, the big guys routinely, and continuously, experience demand letters (reasonable and not). They win some and lose some. On the average, they have a consistent cost of business. And, if they are aggressive, on the average, their costs go down due to their earned reputation for willingness to fight a war of attrition.
Meanwhile, the little guys have to take each of their rare cases more seriously. Even when they are right, and may even win court costs, there is a chance that if they lose the case they would be ruined by the years of their own costs compounded by the crushing debt of suddenly having to pay the fees of the prevailing party. Would you take a one in 20 chance of losing your business over an infringement lawsuit? A presumption of fees to winners promises eventual relief if they win, but devastation if they lose.
The bill probably will not become law. See HR3309 estimated a 36% chance of being enacted: https://www.govtrack.us/congress/bills/113/hr3309/text .
285.Fees and other expenses
The court shall award, to a prevailing party, reasonable fees and other expenses incurred by that party in connection with a civil action in which any party asserts a claim for relief arising under any Act of Congress relating to patents, unless the court finds that the position and conduct of the nonprevailing party or parties were reasonably justified in law and fact or that special circumstances (such as severe economic hardship to a named inventor) make an award unjust.
So ... The presumption mentioned in the article is not a rebuttable presumption that the loser must pay fees, so much a requirement that the loser's case be reviewed to see if it was unreasonable. And ... the door remains open for the judge to decline to order fees, where it would ruin the small party.
If reasonably applied, the law may not be a disaster (not that I am for it). For example, I usually do not appeal patent application rejections, unless I know my case is more than reasonable, reducing the chance of the rare crazy decision against me. The same should be practiced in infringement suits. If your case is somewhat doubtful, don't sue (if you had, there is a significant chance the Court would find your case unreasonable and order payment of defendant fees). If you have a great case, the likelihood of both losing and having your complaint held unreasonable is vastly reduced.
November 12, 2014
Tesla, the Long Story
The Tesla team was smart to break the mold and show case the inherent advantages of electric propulsion (instant torque, low center of gravity). I suppose part of the success was a freak in timing: advanced materials, more efficient Li-Ion batteries (from personal electronic devices ) became available, better power control systems, and the doomed "zero emissions" standard in California all came together.
I did not know the basic chassis was based on the Lotus Elise.
Living in the SF Bay area, I am quite happy they took over the old Numi motors manufacturing plant, and brought back some manufacturing jobs to the region. Too bad it made no sense to also build the giant battery factory (giant factory, not giant batteries) here, but in Nevada.
Tesla gives free access to its patented technology. So what are their patents anyway? Batteries, I guess. Nothing new about the chassis or power train, it there?
November 11, 2014
Another DNA Assay Bites the Dust?
I do not see a lot of hope for
this patent in light of recent Court holdings. Claim 1 of the patent
6,258,540 is directed to amplifying and detecting the presence of a
paternally inherited nucleic acid of fetal origi n in a maternal blood
sample. Generic embodiments of detecting natural subattances in their
natural environment do not seem to pass the Patent Office lately.
n in a maternal blood sample. Generic embodiments of detecting natural subattances in their natural environment do not seem to pass the Patent Office lately.
For example, in Myriad, even synthetic DNA strands of a natural sequence were found ineligible for patenting. In Mayo v. Prometheus, the correlation of a UNNATURAL metabolite to drug efficacy was held to be an ineligible natural phenomenon (crazy).
Here, how could the natural phenomenon of unmodified fetal DNA in maternal blood pass such a high eligibility standard, linked only to generic detection methods in the claims?
Novenber 10, 2014
Another AIDS "Cure" - Requires CRISPR Attack of Patient-Harvested Immune Stem Cells
HIV enters T cells through chemokine receptor type 5 (CCR5), apparently found unnecessary to adequate functioning of the T cell. The gene can be very selectively knocked out using a bacterial CRISPR/cas (clustered regularly interspaced short palindromic repeats) system, normally used to cut bacteriophages in bacteria "immune systems".
HIV patient blood stem cells are harvested, treated, and returned. The CRISPR/cas system does not cause any random mutations in the stem cell. Even if the knock out treatment is not 100% efficient, those cells converted to CCR5 negative can take up residence in the patient's bone marrow and provide a HIV incompatible line of T cells.
This system is a little more complicated to practice than the previously noted therapeutic virus (TV) system (https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US20140030792.pdf ), which would theoretically require only administration of the TV to the patient. However, this system appears to be a promising option to rebuild immunity in AIDS patients.
November 9, 2014
Illegal Photography of Public Buildings in Europe
Seems a little absurd that someone can place a structure in the cityscape and have the nerve to tell people they can no longer point their camera that way.
At first, I thought this article may be about security. I remember climbing a mountain outside Seoul KR years ago and being warned not to take any photos of the city. Now with all the satellite images, it hardly matters. (Remember when the street maps of Moscow were all drawn out of scale so they could not be used to target missiles?)
Reminds me of the old legal case of product placement in movies. A movie producer was sued for including a retail product (like a VW car, or something) in the movie. The U.S. Federal Court found for the defendant's right to include incidental images of products in movies. Otherwise, how could one shoot a movie? Funny, now the retailers have to pay producers to include their product in a movie. .
Same with the Eiffel Tower. I am going to send Paris a bill for product placement of the Tower in my vacation slides.
November 8, 2014
Vascular Tissue from FibroBlasts Treated with an RNA and Growth Factor(s?)
The unpublished work apparently includes a step of freaking out fibroblasts with a so-called small molecule poly I:C (polyinosinic:polycytidylic acid) double-stranded RNA that gives the impression of a virus attack. Then the fibroblasts were treated with growth factors, such as vascular endothelial growth factor (VEGF, which binds to the host cell receptor TLR3) to miraculously not only transform some fibroblasts into endothelial cells, but creates an environment wherein vessel structures anastomose in functional relation with previously existing with normal vessels, e.g., to improve circulation in a mouse model. (Sorry about the long sentence, but it is so exciting.) Introduction of the treated cells into a wound could bridge gaps and aid healing.
Now, I know why they call them fibroBLASTs? Both the fibroblasts and resultant endothelial cells are of mesoderm germ layer origin. So, it is not too big a stretch.
Great work. I am amazed how certain seemingly simple techniques sometimes have such complex results.
November 7, 2014
Therapeutic Virus Can Only Reproduce in Infected Cells While Encoded miRNAs Neutralize Resident Pathogen - A Cure for AIDS?
The therapeutic virus (TV) is a modified form of the pathogenic virus. The TV is non-infectious to normal cells not infected by the pathogenic virus. This is achieved by selectively mutating residues in an active site of one or more of the enzymes essential for the propagation of the TV. The TV is only saved if infections virus is present to donate the essential enzyme. On the other hand, the TV encodes an miRNA that disables the infections virus.
The TV has the ability enter all normal host cells of the pathogenic virus. For example, any modifications to the enzymes of the TV do not impart significant changes to the three dimensional structure of the enzymes thus maintaining normal packing within the capsid. Because the TV is missing enzymes essential for the propagation, e.g., no functional reverse transcriptase (RT) and/or integrase enzymes, it can not reproduce without the presence the enzymes from the pathogenic virus in that cell.
The TV has pre-miRNAs inserted into its UTR region. In the case of a
In the TV, the miRNA binding target sites are modified so the miRNAs do not interfere with the production of the TV. Therefore, while the reproduction of HIV is blocked by the TV miRNA, the TV can be normally packaged and secreted. The secreted TV can then infect more cells to propagate their beneficial function. The production of the TV continues until all the infected cells in the patient die.
The therapeutic virus that can only grow and reproduce in cells previously infected by pathogenic target virus. The TV is harmless to uninfected host cells. However, the TV encodes an miRNA destructive of the targeted infections virus resident in the same cell but not to the TV. The TV is self limiting to reproduce only, e.g., in otherwise HIV infected cells, where is reproduces itself, while destroying the HIV.
Similar concepts can function
against other viruses, such as Hep C. Applicant is interested in
partner to collaborate in further studies. See Therapeutic Anti-Virus VLPS
November 6, 2014
Not the First Bra, but First Patented "Improvement"
The word brassiere was well in use by the time of the patent, and the specification discusses improvements thereof.
Not the most comfortable looking design (not that I would know). No contours to the cups. Probably would sell well, though, in the upcoming flat chested flapper era.
See original patent at:
Surprising Progress in Battery Energy Storage
The NiCd and Ni metal hydride batteries seem to have saturated their theoretical maximum energy density. Can the Li-ion batteries continue on for another doubling? After that, what is left? You can not get much lighter and concentrated than LiCoO2 , and the electrolytes can only be so concentrated.
Seems the next step will have to be some process wherein reactants are refueled, e.g., hydrogen.
Anyway, the progress in energy density is more significant than I would have guessed.
November 5, 2014
Fortifying Your Applications Against the (Current) PTAB Onslaught
Fortifying Your Applications Against the (Current) PTAB Onslaught
This was an easy to read and informative article on how to strengthen applications for possible review at the PTAB, as it now exists. The good news for me is that most of the practices to strengthen an application in the PTAB environment are the same as I practice in the context of routine prosecution.
Everything has risks and benefits. I have heard some writers suggest it is a bad thing to include a Background of the Invention, or even a Definitions section. There is the risk of admissions or narrowing definitions, but these can be avoided with care, or traded for a stronger application in the context of the invention intended for market.
It seems like there has been a move lately to draft initial claims more focused on the intended market. I have a habit of tailoring independent claims to broadest scope avoiding known art, then backing them up with more focused dependent claims. Lots of claims in the initial filing, but reduced claims before excess claims fees kick in. I had not considered annoying Inter Partes Review filers with a large array of dependent claims. For my clients, this would generally not have a good cost/benefit ratio, since IPR is expected to be rare. But excessive claims may be something to be considered, depending on the nature of the subject matter and market.
The biggest problem I see in these strategies is they live in the present and the rules keep changing retroactively far down the line. Structuring my applications now for the present environment, will I give up claim scope in the more patent friendly environment of 2020?
First Strike From Trademark Empire
Seems certain trademark Kingdoms aggressively dispute, more as a warning to others in the future than to stop a current new mark. Lucas would probably be willing to spend more on this dispute than the value of any maximum losses they would theoretically incur. But, Lucas aggressive opposition behavior may stifle future unwanted "nods" to their trademark Empire.
Telomerase Arond the Clock
Circularized yeast chromosomes were opened with a telomerizing inserts at various positions. Interesting all remained viable but for where essential genes were too close to the new telomers.
Now constructs can be opened anywhere to present more eukaryotic linear structure.
November 4, 2014
Another Challenge to Patentable Subject Matter - Stem Cells Challenged in SCOTUS
I thought it was overblown that Dr. Loring, the stem cell patent opponent at Scripps, stated " it's very important to just wipe this thing off the books". Well, yes and no. The patent is a "thing", but maybe there is no rush to get it off the books.
See SCOTUS Petition at:
"Loring has said other qualified scientists could have isolated the cells with methods used for finding animal embryonic stem cells, so the advance was obvious.
Moreover, embryonic stem cells are a product of nature and therefore not patentable according to a 2012 Supreme Court ruling, they say."
The methods do appear routine, maybe even for 1995 - monitor and mate female primate and harvest blastocyst embryo by flushing, disaggregated cells onto fibroblast feeder cells, grow, freeze, and store. See, the issued patent: http://www.google.com/patents/US7029913 . It is possible the methods were new, and arguably non-obvious, however this is not what is claimed:
1. A replicating in vitro cell culture of human embryonic stem cells comprising cells which (i) are capable of proliferation in in vitro culture for over one year without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.
OK, what have we got here? A generic composition claim without structure and distinguished only by desired characteristics. How did this get through the patent office, even in 2006? The cells probably inherently existed (burden on Applicant to prove otherwise), so they are not new (failing Title 35 § 102 and 103 requirements). The claim is to all cells with these characteristics, even though they only show a couple of similar ways to obtain them, therefore the claim fails to meet the standards of enablement and written description (Title 35 §112) requirements. The cells appear to be in an unmodified natural state (unless the process, not in the claims, significantly modified them in some way), so they would fail patent eligibility under Title 35 §101, even under the pre-Myriad standards. The patent is a "thing".
Best case, the particular method of isolation and maybe a product by process (MPEP 2113 - http://www.uspto.gov/web/offices/pac/mpep/s2113.html) claim should reasonably have issued.All that said - what is all the hullabaloo about? The priority date is 1995 to a Continuation in Part application and Continuation application filing date is 2001, so there can not possibly be much time left in this patent in any case (2015 max?). I guess this is just one more chance for a bad case to make more bad law at the Supreme Court.
November 3, 2014
Easy Overview of Eligible Material for Patenting
Here is relatively easy to understand overview of patent eligibility challenges for inventions in the biosciences.
It is more important than ever to support and claim "something more" than natural phenomena. You can only claim what is disclosed in your application. So, there must be a description of the aspects of the invention (composition, device and/or method) in the application that distinguishes it from what is found in nature.
In biotech, it can often be easier to patent claims directed to biomolecules if, e.g., they are modified away from the natural sequence, or used in a way that focuses on solving a problem in a non-obvious way.
November 2, 2014
PTO Crowd Sourcing Novelty Searches
At first glance, novelty always seems such a straight-forward issue to me. But I am not the one who has to do the search.
The PTO seems pretty good at searching patent and journal databases. However, there are a lot of publications (and offers to sell?) not so easy to find. Maybe Google will have some suggestions.
Benefits of Cell Cluster Metastatic Growth Outweigh Mobility Disadvantage?
Benefits of Cell Cluster Metastatic Growth Outweigh Mobility Disadvantage?
It makes sense that tumor cell clusters would be more successful in metastases, and that plakaglobin (gamma-catenin) would have something to do with the adhesion necessary for clustering.
Working against metastasis is the fact that most metastasis involve migration in and out of vessels through tight endothelial layers. It is hard for me to imagine clusters accomplishing this feat.
For example, try to imagine a cluster of cells doing THIS:
November 1, 2014
Malaria Vaccine is More Than Just a Me Too Vaccine
It is hard to criticize a malaria vaccine that prevents illness in half the children. One would hope that even those that come down with the disease will have a milder form. If the kids can make it to an older age, their chances of survival go way up. And this is the first vaccine. More to come later, I hope. Thanks Gates Foundation.
October 31, 2014
Broadest Reasonable PTAB
My biggest day to day problem with the Broadest Reasonable Interpretation (BRI) standard is that it is typically unreasonable. Often it is unreasonable interpretation of terms in ordinary context. Most often, the BRI as asserted by Examiners, fails to acknowledge a key part of the standard - the BRI In Light of the SPECIFICATION.
Will the PTAB also over extend the BRI by ignoring the context of the specification? I doubt they will not prepare a fact supported construction table (considering the file wrapper?). Hopefully, they will at least not go on a "gut feeling".
NPEs Can No Longer Afford to Fight
When I was a scientist, I ran my experiments changing only one variable at a time. It seems the Courts and Congress are trying to run an experiment changing three variables at once. No guessing how it will come out and what it will mean.
One thing is for sure, the pendulum has swung too far. Now that the trolls and mean ol' NPEs are in their place, do you suppose the media will start singing the praises again of the noble inventors changing the world from their garages?
October 30, 2014
New EPO Guidelines Published
Although we are a U.S. firm, we instruct a lot of prosecution at the EPO. I have downloaded the new Guidelines.
It is great that the
changes are so clear to see in the mark up.
It is great that the changes are so clear to see in the mark up.
My favorite part is the Inventive Step analysis.
A thorn in my side has been "added matter" rejections during claim amendments. I couldn't find a good discussion of that. Hmmm. Where is it?
On further review I see
On further review I seeArt 123(2) - The European patent application or European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed.
From there, I wonder where they get - the content of the application as filed must not be considered to be a reservoir from which individual features pertaining to separate embodiments can be combined in order to artificially create a particular combination" ? Part H, ChV 3.2.1
I always thought teaching two generic elements, each with a variety of species, would teach the smart people skilled in the art that any of the combinations were considered inventive alternatives. The combinations, expressed logically (without having to list each combination separately) should be considered "unambiguously derivable"; but that is just me. For example Teaching A1 or A2 and B1 or B2 should be considered to teach 4 alternatives.
However, the new section at Part H, ChIV 2.3. states "When assessing the conformity of the amended claims to the requirements of Art. 123(2), the focus should be placed on what is really disclosed to the skilled person by the documents as filed as directed to a technical audience. In particular, the examiner should avoid disproportionally focusing on the structure of the claims as filed to the detriment of the subject-matter that the skilled person would directly and unambiguously derive from the application as a whole." This gives me hope that the EPO will realize that just because an inventor uses convenient means to describe combinations and permutations does not mean the combinations are not taught to one of skill in the art.
We will see if the EPO will ultimately see the objectively taught logic of "or" and "and".
October 29, 2014
Soft Where? - in Patents. A Basic Overveiw of Software Patents
Here is a basic overview of software patents.
I was surprised at the small percentage of IT companies that actually bother to patent their software.
The funny thing about software patents to me (mostly working in molecular biology/medical devices) is that subject matter is such big deal in software. From what I see in the structureless result oriented phraseology of software claims, the bigger issue should be section 112 enablement and written description.
What software really needs is a copyright with a Doctrine of Equivalence, I think.
October 28, 2014
Ebola Vaccine Balue Not In Annual Sales, But In Peace of Mind
Ebola Vaccine Value Not In Annual Sales, But In Peace of Mind
While Influenza may have a multibillion dollar annual market, Ebola would usually have only a multimillion dollar market. Still, the benefit of vaccinating people endemic areas is multibillion. So, although private businesses can not rationally invent billions, it is good that governments are willing to subsidize.
Once a vaccine is in place (and it will be, e.g., since Ebola does not present many of the problems inherent in HIV vaccines), West Africa could be generally protected and/or outbreaks could be promptly encircled with a multilayer ring of vaccinated populations.
SScare the West enough and we will spend. Now, how about malaria?
October 27, 2014
An miRNA Influencing Binge Drinking
Now ... to identify the control system for the miRNA. Hmmm, can you make an miRNA that cleaves a miRNA?
I have been asked on the side why I would want to cut the miRNA with another miRNA. Actually, it was intended as a joke. I have a nasty habit of throwing in a joke on serious sites without using a smiley emoticon ;)
In many instances, I believe miRNAs cleave target mRNAs (e.g., encoding BDNF). I would not be surprised if there are subclasses of miRNAs that attack other miRNAs. However, this may not be a preferred mode to solve alcoholism, since it would require direction of an expression vector into the brain of a patient.
October 26, 2014
How Can We Detect Differences in Licensed Biosimilars?
It seems each state has the option of modifying the Federal mandate to allow the biosimilar option. Several states believe there would be a net benefit to require the prescribing physician be notified if the patient is given a biosimilar over the name brand drug prescribed.
How similar is "biosimilar"? Biosimilar means that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” That is easier said than done, but is probably successful in the majority of cases. See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
The manufacturer of a proposed biosimilar product will likely have a different manufacturing process (e.g., different cell line, raw materials, equipment, processes, process controls, acceptance criteria) from that of the reference product and No Direct Knowledge of the Manufacturing Process for the Reference Product.
I worked designing purification processes for recombinant peptide therapeutics for many years. There are many routes to a purification, and the product will never be exactly the same (lyse cells, precipitate proteins, affinity column, size exclusion, concentration/formulation; or, lyse cells, affinity column, hydrophobic interaction, size exclusion, concentration/formulation). The active peptide and impurities would be different all along the way. The product Will be different, particularly if there is peptide refolding of covalent modifications, such as pegylation involved.
Should the prescribing doctor be informed? The whole cost/benefit analysis seems to depend on informatics. Notice of a switch to a biosimilar seems like an administrative burden, and most doctors will probably ignore or be unaware of the notice. On the other hand, the biosimilar manufacturer may be required to provide clinical data, but the statistics may not be strong. Once the biosimilar gets out for full scale use, minor differences in efficacy and side effects may become detectable, but only if observations are systematically received from the clinical environment.
Data from notified doctors would probably be sporadic, anecdotal, retrospective, and include their biases. My best guess is that it may be more effective for the information to be systematically retained in databases and a comparison of name brand and biosimilar compared in the whole population of outcomes. But it may not hurt to inform the doctors, if they have time to listen.
October 25, 2014
Attack the Genius ... I mean the Genus
It is fun to be overly simplistic, so here I go ...
The main problem is a vicious cycle of government and media feeding off each other identifying "problems" (real or imagined), and "doing something" whether it is directed to a problem, or not.
Often too, the problem is generic laws attacking specific problems.
October 24, 2014
Despite Media Hype, Patents (and Applications) Still Offer Advantages to All
Thomas Jefferson would spin in his grave to hear all the folks suggesting that "patents stifle innovation".
Small companies may feel like patents are blocking their progress, particularly in crowed or high tech fields. For example, a high tech device may include 50 patented technologies; no one company owning more than 10. A small company with just one relevant patent can not even practice their own invention because of the other patented elements in the device. Worse yet, their patent may be to a specific improvement to a active pioneer patent owned by another (however note neither can the pioneer practice the improvement).
Ironically you hear large companies proclaiming the loudest that patents are stifling. They may be annoyed, but they can practice in the field by using their portfolio of defensive patents. Mutual Assured Destruction can ensue if one big guy sues another for infringement. "If you sue me based on your patent '789, I will sue you for your infringement of my patent '345 in this field, and for your infringement of my patent '567 in an entirely different field!" If the big guys do ultimately get in a legal fight, they typically arrange confidential settlements, so the next guy will not know the exposed strengths and weaknesses of each parties positions. Trial to verdict is not the norm.
So, what about the small guy? With a patent (or application) in hand, you can approach the big guys, even without an NDA. The big guy may buy you out. But if they try to steal your patented ideas, you at least have the law on your side. No amount of fancy attorneys can change the facts or the law. They may try to win a battle of legal attrition, but the Federal Courts have shown more of a propensity lately to award legal costs to the winner.
All that Big versus Little stuff aside ... Patents, and even applications, can create uncertainty and a major barrier to entry for competitors. You never hear the story about the cat that did not get caught in the tree. How many competitors elected not to enter a market just because their main competitor would have an advantage protected by a patent?
R&D Cash Flow at Amgen?
This seems really strange. The suggestion is that Amgen should split the R&D group from the manufacturing and sales?
R&D, even at Amgen, is highly unpredictable. You can not force serendipity. Moreover, the only asset is the intellectual property and the "people". But this has no cash flow.
Sounds like a bad idea, unless there is something I am missing.
Evidence Suggests There is Not a New Patent Litagation Problem
The main problem is a vicious cycle of government and media feeding off each other identifying "problems" (real or imagined), and "doing something" whether it is directed to a problem, or not.
October 23, 2014
What Drugs are Hiding in Your Micro-Biome?
I always thought the balance between normal micro-biome members would be found in the microenvironments they create, e.g., inhospitable to other organisms. Interesting that a "new antibiotic" interacting in a human habitat.
I have read a lot of micro-biome research lately. Lots of correlations. What would be more interesting would be more data on proof of causation.
October 22, 2014
Children of Mayo are Not Routine and Well Understood
It seems the Court rulings (especially the SCOTUS) have been based on gut feelings that the patents were inappropriately broad. Then, subjective (not subject to ready scrutiny) bases for rejection were fabricated in non-fact-based obviousness analysis to "justify" the desired outcome. Too bad the presented analyses are now affecting a range of different cases in unforeseen ways.
I used to think section 103 arguments were subjective, but in comparison to 101 lately, 103 incorporated structure/function, recognized result effective variable, and motivational arguments seem down right objective.
October 21, 2014
Desire of Great Charity Does Not Take "Property" Out of IP
Doctors without Boarders is great. However, the importance of enabling a charity to give cheap drugs is immaterial to intellectual property rights and provides only a short term benefit.
Regarding the "novelty and inventiveness" requirement in India. It seems strange that improvements are not considered in isolation on their merits. That is, if the improvement is a new drug, the standard of novelty and inventive step is different than when the improvement is to a new and inventive change to a drug formulation.
When the original drug patent expires, everyone is free to make and sell the drug. What Is The Problem? If someone develops an improved formulation, they can patent that improvement, without stopping use of the expired formulation. And, if the new formulation improvement were so obvious (and allegedly not inventive), why didn't the Indian pharma companies make the improvement themselves before the western companies taught the new formulation in their applications?
There is no such thing as "evergreening". Patents expire. New and inventive improvements can be developed through new research later and the improvement has a separate patent application. Again, this does NOT prevent anyone from practicing the expired parent patent.
Why must those, apparently feeling guilty for taking something that they do not own, justify the taking by vilifying the owner? Again, when will the takers ever say Thank You?
October 20, 2014
Patents That Kill - Researchers Allegedly Divert Away from Cancer Cures
Patents that kill - there are said to be 30 times more clinical trials for recurrent cancer drugs than for preventive drugs. The author suggests researchers divert funds away from cures and prevention to the more hopeless indications. No clear motivation is given. How about this - recurrent patients are more willing and appropriate for experimental drugs.
It is notable that prevention of cancer is a more generic idea and would have more focused strategies than attacking each of the various cancers specifically. Further, I suspect the author's data ignores research in the fields most important in the prevention of cancer. Prevention of cancer is not a new pill, but a social cure for smoking, drinking and over eating.
Old story, but controversial. What do you think?
October 19, 2014
NGS Detects Exome Abnormality in 25% of Patients with Suspected Genetic Disorder
The next generation sequencing (NGS) method is not new, only the mode of data analysis. The Illumina HiSeq next generation sequencing technique was used, wherein even rare sequences are first amplified in a bridge cloning scheme on a solid support. Next, a polymerase sequentially adds blocked fluorescent NTPs to any clone on the solid support requiring that NTP. Fluorescence data for each clone location on the solid support is collected. The whole solid support is deblocked before the addition of the next different NTP to the whole solid support.
The actual article is available at:
Clinical Exome Sequencing for Genetic Identification of Rare Mendelian Disorders. JAMA, http://jama.jamanetwork.com/article.aspx?articleid=1918774
The technique allows redundant sequencing of the patient's sample, so each exome may be sequenced hundreds of times. This allows detection of patients who only carry the mutation in a small percentage of their cells (low-level mosaicism).
I was wondering why the researchers focused only on the Exome of peptide encoding sequences. The HiSeq is quite capable of detecting any number of sequence variations at introns and exons. The exon focus is probably due to the legacy of Mendelian clinical data including only mutations in proteins. In any case, 25% of the patients with unexplained conditions presented a diagnostic mutation. 87% of the detected mutations were de novo in the patient; some somatic.
The adverse side effect of whole-exome sequencing was about a 2% rate of suspected nonpaternity by at least one parent.
October 17, 2014
Notice Pleading of Patent Infringement Gone - for Pro Bono and Trolls
The judicial Conference has eliminated the Rule 84 asnd associated Appendix forms. http://www.insidecounsel.com/2014/09/22/the-judicial-conference-of-the-us-makes-small-rule
Patent trolls will no longer be able to blindly shot-gun Complaints against any number of Defendants (nor will pro bono Plaintiffs be able to simply file).
Fedreal Rules of Civil Procedure - Forms:
The forms in the Appendix suffice under these rules and illustrate the simplicity and brevity that these rules contemplate.
Here is the form for pleading patent infringement:
COMPLAINT FOR PATENT INFRINGEMENT
1. <Statement of Jurisdiction. See Form 7.>
<a. For diversity-of-citizenship jurisdiction.> The plaintiff is [a citizen of State A] [a corporation incorporated under the laws of State A with its principal place of business in State A]. The defendant is [a citizen of State B] [a corporation incorporated under the laws of State B with its principal place of business in State B]. The amount in controversy, without interest and costs, exceeds the sum or value specified by 28 U.S.C. § 1332.
<b. For federal-question jurisdiction.> This action arises under [the United States Constitution; specify the article or amendment and the section] [a United States treaty; specify] [a federal statute, ___U.S.C. § ___].
<c. For a claim in the admiralty or maritime jurisdiction.> This is a case of admiralty or maritime jurisdiction. <To invoke admiralty status under Rule 9(h) use the following: This is an admiralty or maritime claim within the meaning of Rule 9(h).>
2. On <Date>, United States Letters Patent No. <__________________> were issued to the plaintiff for an invention in an electric motor. The plaintiff owned the patent throughout the period of the defendant's infringing acts and still owns the patent.
3. The defendant has infringed and is still infringing the Letters Patent by making, selling, and using electric motors that embody the patented invention, and the defendant will continue to do so unless enjoined by this court.
4. The plaintiff has complied with the statutory requirement of placing a notice of the Letters Patent on all electric motors it manufactures and sells and has given the defendant written notice of the infringement.
Therefore, the plaintiff demands:
(a) a preliminary and final injunction against the continuing infringement;
(b) an accounting for damages; and
(c) interest and costs.
Date: <Date> <Signature of the attorney or unrepresented party>
All one had to do was fill out this form with a generic allegation to state an initial case. This helped small inventors who could not easily afford counsel. Like so many other things, because some abuse opportunities, they are lost to all. The good news is that the initial quality of pleadings must improve - minimum notice pleadings are gone.
October 15, 2014
Damage to Old Mom Mitochondrial DNA Can Be Passed to Next Generation
The article is a little fluffy, but has some interesting points. In hindsight it does not seem surprising that the rate of mutated mitochondrion genes raises in the eggs of older women. It interesting to see confirmation. However, I do not see how this helps in educating older mothers. The information in generalized and of no specific use with regard to a particular woman or a particular fetus (unless probabilities seem high enough to justify sampling and DNA analysis).
And, the mutations are generalized. Rates of mutations are higher with age, but not for any particular gene. So, I don't see any big benefit in useful information to mothers.
Still the part about the mitochondrial DNA bottle neck was interesting. I would like to know more about how mitochondria keep their genes fresh over the generations.
The Cost of Restricting Patentable Biotech Subject Matter
It may be reasonable to deem a natural sequence, correlation, or even an expert system to be non-eligible subject matter. It is pushing it to deem analysis of a natural phenomenon to be non-inventive (obvious). Now, I suppose it would be deemed obvious to discover a sequence, elucidate a correlation with a disease state, and develop a clinical dataset to direct best practices - three previously unknown things, in combination, that are obvious all together.
The policy basis in the Constitution for patent law is to promote the progress of science and useful arts. Where are the proclamations of obviousness from the technically ignorant going to lead? There comes a point where they will be poisoning the well.
October 14, 2014
A Direct Approach to Myriad - Or Is It that Simple?
The article provides a simpler analysis to the same outcome as the SCOTUS, but it seems to me a hindsight construction, with contrived premises.
For example, a "composition" may a product of two or more substances. But the article starts with the premise that the product is the substance. The article says "an isolated naturally-occurring DNA segment does not fall within the above definition because it is a single substance and not a mixture of substances." The article cites no case law suggesting a mixture of substances integrated in a reaction to a unitary product can not be a composition. In fact, the article finds the unitary product of a "synthetically created" nucleic acid to be a composition of substances. So, it looks like the simpler path to ineligibility was fabricated by misinterpreting composition and by biasing a composition depending on the rout to production. In fact, common usage of the term "composition" does not depend on how the composition of two or more things got to their present state. Further, a new composition can be a new combination of fewer substances. Or, a composition can be new if it is changed in even a minor way, e.g., such as by cutting a strand and producing previously existing 3' and 5' ends. So the isolated BRCA gene was a composition (e.g., of many nucleotide bases) that are different from a chromosome containing BRCA.
Because the article deemed isolated genes not to be compositions, it had to further show in simple hindsight that isolated genes are also not items of manufacture. Of course this can not be done, since isolated DNA is in fact the product of an isolation manufacturing process. To get around this annoying fact, (and regrettably losing the desired simplicity of analysis) the argument is presented that the manufactured genes have no new utility. However, it is notable that "new" and "useful" aspects of section 101 are treated separately, and alleged lack of utility does not somehow destroy newness of a composition or item. This is immaterial though, because isolated genes do have utility, and it is different from the utility of the natural un-isolated genes. For example, the isolated genes can be inserted directly into an expression construct, can be easily melted to separate strands, or hybridized to a specific target only associated with the isolated sequence.
So, the simple route said to provide the same outcome seems faulty to me. An isolated nucleic acid strand is a composition, composition claims are not subject to the method of their production, utility is not required for a composition to be new, and a composition with inherent advantages solving real problems does have utility.
Different perspectives on the facts can lead to opposite conclusions. I am not saying the Myriad claims were valid, only that the compositions should have passed section 101 for review under sections 102, 103, and 112.
October 13, 2014
PCR to Triage Possible Ebola Patients
Ok, reverse transcription to PCR is not the kind of thing that provides results useful at the airport. However, it could be useful in triage of patients instead of days of quarantine.
Primerdesign has a $6000 quantitative PCR machine and some hot start reverse transcriptase kits to do a pretty quick detection of about any RNA virus (among other things). http://www.primerdesign.co.uk/products/9633
If the kits are not too expensive, it could be cost effective, even in developing countries, to know right away if a patient with fever and other suggestive factors is indeed infected with Ebola, or not.
China Says Genetically Modified Organisms (GMOs) May Not Be All Bad
Some find it fun to be political and show how smart you are by pointing out the negative side of every compromise. But, eventually reality strikes. Yes, there may be negative aspects of GMOs (e.g., selecting for glyphosphate resistance [not sure why those hating glyphosphate whine about this]). (BTW glyphosphate is not natural, and it makes me nervous to use, but see the MSDS for yourself http://www.alligare.com/assets/pdf/Glyphosate_54_MSDS.pdf [but I digress - as usual]).
Anyway, China knows that the most promising way to get more nutritious food (e.g., golden rice, and fast growing fish) to her population is through GMO foods. How about drought resistant crops? Water usage and fertilizers of the 60's green revolution have been pushed to the limits. Too bad western media paints GMOs with such a broadly negative brush. However, in the West too, the reality of GMO benefits will eventually win over hearts (and pocketbooks).
Moderation in all things. Life is in balance. We can not throw out your options based on general prejudices unsupported by (sorry to say it) risk/benefit analysis.
October 10, 2014
Blood Filter Away Our Ebola Problems?
Hey, wait a minute, weren't viruses first called "filterable agents" because they passed through filters?
See a copy of a related patent at:
Apparently these filters present carbohydrates having an affinity for any number of viruses and other sources of pathology. Still, knowing little, I suspect little benefit can be derived from capturing some of the virus in a patient's blood, given much of the virus is resident in endothelial and liver cells.
Anyway, it may not hurt to look into this.
October 9, 2014
No Need to Be Defensive - Patent Litigation is Down
One of the most powerful aspects of a patent (or even patent pending) is the uncertainty it causes in the market place. Sometimes there is more value in having a presumed valid patent of record than taking the risky step of enforcing the claims (even at risk of providing a laches defense).
There have been occasions where clients have requested a validity opinion after they received a cease and desist letter suggesting possible infringement of a patent. When I developed strong evidence of invalidity, the client elected to continue practicing the claims. The patentee never sued, knowing their patent was invalid. They preferred to avoid a finding of invalidity so they could continue holding the patent over the heads of other players not having the funds to obtain an opinion or sophistication to call their bluff.
The option of post grant review procedures has also probably reduced federal litigation, as it was intended. I assume settlements are up, shifted more in favor of possible defendants.
October 8, 2014
"Good Wife" Not Totally Negative on GMOs
It is hard to prove a negative, especially when people's minds are made up already. How to prove "Frankenfood" is not going to kill us, maybe, someday? The biggest problem seems to be the human interest aspect of GMO sensationalism. Framing GMO as a danger sells more news.
The other problem with the image of GMOs is the aspect of worm killing and enabling more pesticide use. The media does not seem interested in praising the GMOs that enhance nutrition or lower food costs. The public does not even know about GMOs that can provide life saving recombinant drugs, with the possible exception of the recent ZMAP anti-ebola antibodies ( http://time.com/3457472/see-how-ebola-drugs-grow-in-tobacco-leaves/ ).
Even with the cost/benefit ratio clearly in favor of GMOs, I do not see a trend toward an improved image. I believe some people find it entertaining or fulfilling to be cynical.
October 7, 2014
What One of Skill in Europe Knows - Will EPO Lighten Up on Added Matter Rejections?
One of the most frustrating things for me in patent practice in the last few years has been the illogical and unfair added subject matter rejections in Europe. For example, if I outline a disclosure with a generic description of A+B+C elements in the introductory paragraph, then had paragraphs each describing alternate species elements a1, a2, a3; b1, b2, b3; c1, c2, c3, the EPO says I have not described an embodiment of a1+b2+c3. That is, in Europe one of skill from reading the disclosure would not understand that one alternate of a first element can be practiced with an alternate of a second element.
I have seen situations where an embodiment was described in a paragraph, and alternate elements for the embodiment in the next. The EPO would insist one of skill would not know to practice any one of the alternates in combination with the immediately preceding embodiment. It was like the paragraph of listed alternates did not exist at all. The EPO insisted, combinations with alternates were "new matter" unless all elements of the combination were single paragraph, or in a single sentence. It got so bad, I began the practice of drafting special paragraphs for Europe wherein I would systematically describe each permutation of the invention - a1+b1+b1, a1+b1+c2, a1+b1+c3, a1+b2+c1 ... It was not pretty.
I know they have policy reasons to prevent inventors from falling back on alternate embodiments to avoid novelty rejections. But they threw our the baby with the bath water.
The old added matter guidelines ( http://www.epo.org/law-practice/legal-texts/html/epc/2013/e/ar123.html ) stated:
“may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed”
There is hope. The new guidelines (Art. 123(2) EPC) state:
“When assessing the conformity of the amended claims to the requirements of Art. 123(2), the focus should be placed on what is really disclosed to the skilled person by the documents as filed as directed to a technical audience. In particular, the examiner should avoid disproportional focusing on the structure of the claims as filed to the detriment of the subject-matter that the skilled person would directly and unambiguously derive from the application as a whole.”
Great! "what is really disclosed to the skilled person ...[in] the application as a whole." Yay.
Maybe now the European Union will have more respect for what even their less bright ones of skill in Europe would know from reading a disclosure with alternatives. Where the theme is disclosed and variations are disclosed in the context of the theme, variants of the theme are understood by one of skill. Some variations may not be as good, but even Mozart knew that.
October 5, 2014
HIV Originated in the 1920's Kinchasa
Amazing that HIV did not venture substantially out of Africa for the first 50 years. Further, the earlier O strain of HIV remained only in Cameroon.
October 4, 2014
Don't Rush to Finalize Manufacturing Process Description
That was a good overview. Fun to read because it relates to my prior experience developing purification processes.
Although there is a rush, I see no need to move to small scale batches with cGMP too early. Best to focus more on the best process early. There have been many times I have seen the process formalized too early. Once the process becomes part of licensing documents, it tends to be written in stone and improvements are hard to insert. I can think of products that used ridiculously inefficient and expensive processes for 20 years of manufacturing, that could have been improved early.
That was good advice on preparing additional example compounds. You want to find the overall (PK, Activity, stability) compound for yourself. Importantly, in order to claim a genus of compound, most patent offices require that you reduce to practice (actually or constructively) a variety of species of the compound across the full range of the genus. Some countries (e.g., China) tend to only allow claim protection to those particular compounds you actually synthesize and characterize.
October 2, 2014
Another Attack on Patent Claim Scope - Festo Expanded?
Another couple of attacks have occurred on the doctrine of equivalence. First, a summary judgment where there are still material facts requiring review. Second, whereas Festo (SCOTUS 2002) http://scholar.google.com/scholar_case?case=8250508786110786578&q=Festo+Corp.+v.+Shoketsu&hl=en&as_sdt=2006&as_vis=1 ) has disallowed equivalents for specific claim elements narrowed in prosecution, here the larger associated structure also lost equivalents.
An amendment during prosecution, not associated with the an aspect critical to showing infringement, was raised to eliminate reasonable equivalents to a larger element. Instead of revoking equivalents to the precise sub-elements subject to the narrowing amendment (as held in Festo), this Fed Circuit case revokes equivalents the entire structure they were a part of. This really muddies the waters because the Court does not describe where the loss of equivalents ends. Does it include any part in contact with the amended (poisoned) part?
The patent holder had amended the aspect of "the seal has a first end comprised of a bellows-shaped part sealingly attached to said holder, and a second end comprising a self-sealing membrane portion interiorly formed at an end of said bellows part".
The amendment concerned part of a seal, which was a part of a trensfer member, the Fed Court, I believe misinterpreting Festo, decided to disqualify equivalents to the entire transfer member. The Court insisted that:
"Although the applicant eliminated the “after use” language, the applicant nonetheless added the requirement that the seal have a first and second end with distinct elements. This narrows the seal limitation, which in turn narrows the transfer member limitation."
An infringement defendant employing an equivalent of a claim element wins a summary judgment because an unrelated part of the element was narrowed in amendment during prosecution. This is like losing equivalents to an entire car because you amended to narrow fuel system to carburetor, then having an infringer released because they used a mechanical fuel pump instead of an electrical fuel pump (the court not allowing equivalents to an electric fuel pump just because the patentee had amended the claims to require a carburetor). [I use car analogies a lot - http://www.biopatent.com/cars.html ]
I remember when Festo first came out. I thought it would be a disaster. But, now this. Where is the line of lost equivalents to be drawn now? Change a "fastener" to a "bolt", do you lose the whole car (without even a hearing of facts)?
October 1, 2014
Distinguishing "Identical" Twins with SNPs
A company called Eurofins apparently detects single nucleotide polymorphisms (SNPs) that arise soon after the twin cells split. They must be fairly rare mutations. I wonder if there are always enough of these mutations for the technique to work. Typically there are only about 10-6 mutations per cell division. One estimate is that each individual carries, on the average, approximately 359 post-zygotic mutations that happened early in development. There is often mosaicism, so the mutations are not present in every tissue sample. I guess out of all those mutations, some show up on the Eurofins SNP library. Or, do they just brute force it and do some systematic gene sequencing?
Eurofins says rare mutations will occur early after or before the ovum has split into two, and that such mutations will be carried on into body and sperm cells, and these are what they detect. http://www.eurofins.com/en/forensic-services/forensic-dna.aspx&
Wall Wall Street Journal report on a similar topic. http://online.wsj.com/article/PR-CO-20131210-900237.html
September 2014 Entries:
September 30, 2014
Inventions Lost in the Translation - Inventor Drafted Applications
Why should professionals draft patent specifications? Because the intellectual property is the claims, AND you can only claim subject matter supported by the specification.
I actually draft the claims first, then determine what is necessary to support the full scope of the claims. I further fill the specification with a variety of fall back positions (as insurance against surprise prior art references). The specification is the tool box have to depend on to work around the inevitable rejections in the first Office Action.
You need to describe a range of species to support a generic range for each claim element. If you are going into Europe, you must describe a range of specific preferred embodiments, not just ranges of each element (for some reason, one of skill in EP can not derive the combination of A and D from A or B with C or D).
Often when Examiners can not find combinations of prior art references that reasonably render your claims obvious, they construe a critical term beyond reason in order to make it mimic this aspect in their best reference. If your specification has unambiguous definitions of all key terms, you can prove a different interpretation is unjustified. If the definition includes bracketed parameter ranges for the term, you can use alternate parameters to adjust the term outside the range of cited art.
I find specifications by laymen often include admissions (e.g., what is not new) that work against them. Another common problem is describing devices according to what they accomplish rather than how structures interact to provide a function.
I will not even discuss claims beyond the fact I have never seen layman claims that were not ambiguous or hopelessly narrow.
There is the expression - you can pay me now, or you can pay me later. Actually, it is not true in this case. If your specification is unprofessional, is it already too late to obtain claims of reasonable scope, at any price.
September 29, 2014
Who is More Biased About Patents - Federal Circuit, SCOTUS, or Media?
In 1982 the Fed Circuit was assigned the unusual and complex task of reviewing cases in the field of patent law. The policy for assigning the Fed Circuit to patents was to have a single expert for these unusual cases.
I disagree with the basic premise in the article that the Fed Circuit is somehow "captured" by the patent bar and biased toward it (e.g., supporting biopatents). The comment is conclusory, with no supporting facts. The Fed Circuit always hears both sides and there is no evidence that they have made buddies with one side. The comment in the article shows the bias of the journalist writing the article.
The biggest problem with the Fed Circuit/Supreme Court (SCOTUS) axis is that the SCOTUS are patent law inexperienced. Even the article acknowledges that SCOTUS has had long periods of inexperience ignoring patent law, since the Fed Circuit was tasked with patent rulings. SCOTUS can not even read claims (nor can most inventors, but that is another story).
Let's review some facts. The claims in the Mayo v. Prometheus case (method of adjusting dosage of a therapeutic) were poorly crafted. For example, they could have linked administering and determining to active dosage adjustment instead of the scope broadening "wherein" clause outlining the correlation of metabolites to effective dosage in a disembodied fashion. The only real steps in the Mayo method claims were "administering" a drug providing 6-thioguanine and "determining" the level of the metabolite in the patient. These steps were old in the art and the claim should have been invalidated on section 102 anticipation grounds. However, as a procedural matter, section 102 was not an issue presented to SCOTUS in Mayo. SCOTUS had a gut feeling the claim was invalid, but section 101 was the only issue before the Court. So, they just made up some disjointed confusing nonsense and deemed the claim ineligible for patenting. For example, this this muddle was presented in support of the invalidation:
"the administering step simply refers to the relevant audience [huh? Where and how does the claim do this?], namely doctors who treat patients with certain diseases with thiopurine drugs. That audience is a pre-existing audience [what?]; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims [Oh, a section 102 anticipation argument].
The only sensible thing in the rejection is the anticipation argument, inappropriate in the context of the law suit at hand. This was not a basis for a 101 rejection.
OK, this is water long under the bridge, but is one example showing SCOTUS is the one misunderstanding patent claims and biased by public opinion. SCOTUS is not all wrong on all the recent decisions, but my point is that the article concludes the Fed Circuit is biased, without providing any facts. There is a good reason to have the Federal Circuit handle all patent controversies. They are more expert. It is an insult to suggest a bias toward patent attorneys (ironically by journalists biased against patents).
September 28, 2014
Inter Partes Review (IPR) Remains Between the Parties
It is not a surprise to hear the majority of inter partes review (IRP) parties elect to settle. As with other expensive tribunals, settlement is the norm. Here, the additional fee of $14000 on PTAB acceptance (institution on determination a reasonable likelihood petitioner will prevail) is a significant cost. As important is the possible loss of the invalidated claims, and the reserved value to intimidate other "infringers". The value of the remaining uncertainty remains high after settlement (terms of which remain typically remain confidential).
I believe a loss to the patent holder leaves open the possibility to appeal (e.g., Federal Court), but we know what that costs. Best to settle, on reasonable terns to the petitioner, in many cases. /span>
I believe the IPR is only available against patents filed on or after March 16, 2013. With a 12-month time limit, cases with actual PTAB decisions should start to flow in faster. Should be interesting to see the trends, once a representative population of decisions are available for analysis.
Until then, it might be good not to be a beta tester for the system. Avoid the patent death squad.
SSeptember 25, 2014
India's Wiggle Room to Confuscate Drugs Affordably/a>
International law is all about wiggle room and give and take to adjust for the different priorities of the counties.
It hurts to see intellectual property confiscated, but the insult is only psychological where the owner was not working the invention in the country and/or the product was so "unaffordable" in the market that there are actually no significant lost sales.
India's wiggle room is not a nightmare unless they allow products to diffuse to the viable markets. Someone has to compensate the good creators of beneficial compositions and devices for their years of work and risks taken for the benefit of all.
September 23, 2014/strong>
Dangerous USPTO Advice
A USPTO update had crossed through my e-mail concerning the non-infringement toolkit, but never read it, until today. I am not trying to be mean, but ...I was surprised by the bias and dangerous simplicity of the infringer's patent litigation "toolkit" ( http://www.uspto.gov/patents/litigation/ ).
I have only had time to read the part on what to do when "... I Have Been Sued."
I assume a bureaucrat, not a registered Patent Attorney wrote the document. I seriously believe that if a private Attorney (not protected by sovereign immunity) had published this treatise, they would be in danger of bar discipline and lawsuits for incompetence and malpractice.
Even a highly competent attorney has a tough and unpredictable time navigating the paths laid out in the "...I've Been Sued" toolkit page the PTO has published. http://www.uspto.gov/patents/litigation/Patent_Infringement_Lawsuit.jsp
First, the page never once suggests the person sued might consider whether they should STOP INFRINGING THE PATENT! The default assumption is that an evil troll has sued an innocent victim, who is falsely accused of infringing. However, step one, if you have accidentally (or intentionally) infringed a patent, you must stop immediately (even if the Plaintiff is a troll). I can not believe stop infringing is not a listed "option" for when you are sued. Such bad advice they are giving.
Next thing you know, the PTO is suggesting a layman should generate their own Validity Opinion regarding the raised patent in the law suit. An opinion is among the most sophisticated tasks performed by a patent attorney with decades of education, training, and experience. Now, the PTO is suggesting the biased, untrained, defendant should generate an opinion on validity of the subject patent. Warning - Minefield.
We have all had clients say their invention or practices are different from those in a prior art patent. They will talk about the doohickey on their device that is not on the one described in the patent. This, ignoring the fact that the doohickey is not an element of any of the claims. Layman do not understand claims, and have no idea what is a claim construction table (required for duly diligent competent opinions). The PTO "toolkit" mentions the existence of the file wrapper, and suggests it can provide "context". The fact is, I have rarely found a file wrapper useful for "context" of claim term meaning. More often, I have mined the file wrapper for critical fact patterns and juicy nuggets only understood in the context of controlling case law (subtle admissions on claim elements, loss of equivalents for narrowing amendments) - things laymen would not know. Why is the PTO dangerously instilling false confidence in defendants to construe claims they are accused of infringing?
Finally, the PTO suggests reading a glossary of concepts is all you need to see if the subject patent is valid or not. Forget law school and the PTO reg exam. What a fool I was! With all this valuable information in hand, the next step is to simply file a Request for Reexamination, or such.
It would all be funny if it were not so biased against certain citizens, and harmful to others.
Next thing you know, the FAA is going to be publishing a toolkit so we can all fly a Boeing 747 without the need of expert advice.
September 22, 2014
Where Are Those Inventions We Expected, but Never Arrived?
Where are those amazing things I expected to happen in my lifetime? Yes there have been the moon shot, end of cold war (sort of), substantial clean up of industry (see the copper smelting town Anaconda, MT, where is was raised), and treatments for AIDS. All these advances have been kind of mediocre and not well followed through on. Except for maybe the internet.
Where are the flying cars (one in the 60s, several now, but not common), cure for cancer (or even muscular dystrophy or nail fungus), trans-sonic jets, detection of intelligent life (on any planet), landing on Mars, energy so cheap you don't have to meter it ...?
Instead we have new big problems like "countries" that can not control mass murder by their uneducated people, and global warming.
The long article by the admittedly anarchist author offers no solutions, but to tear down the present system. Still, the article did wake me up to my personal disappointment over failed expectations in business, transportation, and medicine.
How can we better motivate enterprise to achieve higher goals?
Spetember 18, 2014
Can Patent Expiration Reduce Availability of a Drug?
One of the scenarios I run across a lot when I talk to "inventors" of consumer products is that they have an idea that must be new because they have never before seen it on the market. I will do a quick search and find that the idea was patented 100 years ago. The inventor can not believe it. Why isn't anyone making and selling this great product?
Ironically, the product is not on the market because the idea has been dedicated to the public domain. Anyone can practice it, so no one does. There is the fear that if the product takes off, someone will jump into the market and destroy the profit.
I wonder if this will ever happen in the pharmaceuticals market. Has it already happened? Seems like there was a time everyone abandoned the vaccines market. The sales did not justify the cost of liability insurance. Government stepped in. Aside from the issue of being sued for not being perfect in saving lives, I wonder if the problem of old drug supply could be solved by the marketplace. Lowest cost reliable honest producers. Hmmm ... China .... try India? AZ, GSK?
September 16, 2014
Opinions on Genetic Patent Eligibility in Australia v. U.S.
I suspect that Australian law also does not allow patenting of substances in their natural form. And that is right.
However, a problem with the current U.S. case law is that, e.g., a new and non-obvious method of using information about the substance is now typically challenged as not patent eligible.
September 15, 2014
Small Inventors - Accidental Targets?
I agree that laws directed to trolls (e.g., NPEs) can be a scatter gun hitting more than the intended target. Some of the patent accumulators are indeed trolls. But the laws can also injure small inventors, e.g., not diligently identified or negotiated with by the big practicing entities.
On the other hand, I do not see the post grant review procedures as purely a disadvantage to small inventors. If the patent is found valid in the review, the small inventor is in a much stronger position against the infringer. Also, the infringer pays the surprisingly high PTO fee for the review. In the mentioned Inter Partes Review, the patent holder is not subject to the recent section 101 (eligible subject matter) case law, but only anticipation and obviousness based on patents and publications.
Over all, small inventors are unintended targets of recent regulations, court holdings, and price increases. But it is not all bad news.
September 12, 2014
Give Examiners a Break ... But Not Too Long a Break
I am sure there is anecdotal evidence of Examiners abusing work from home.
http://arstechnica.com/tech-policy/2014/08/patent-examiners-are-routinely-abusing-work-from-home-privileges/ However, I suppose the abuse would be just as bad if they were working in cubicles.
One thing I noticed when I first started in patent prosecution was that Examiner's are generally over worked and stressed out (although they seem to get paid well enough). However, ever since they started work form home, the Examiners seem less stressed and more friendly. Also, being on the West Coast, I have been surprised to catch them in the evenings, their time.
Those caught abusing lack of oversight should be punished accordingly (two strikes - Union be damned). But they are adult professionals and generally to be trusted.
I do not mind the occasional laughing baby or dog barking in the background.
September 11, 2014
Personalized Medicine Patent Issues
The court cases seem to come up with the "inventive concept" standard for evaluation of the "significantly different" requirement. I work a lot on European patent applications, where they have "inventive step", as the stand-in for obviousness analysis. Inventive step is evaluated according to whether the "objective technical problem, would have been obvious to the skilled person". ( http://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vii_5.htm ) "Inventive concept" reads "inventive step" to me and I can not help but think they are saying not obvious.
The 101 subject matter evaluation seems to require obviousness analysis wherein, e.g., the newly discovered natural peptide is assumed to be obvious old art in itself, and must be combined with, e.g., an unexpected solution of the problem of detecting the peptide. A western blot or ELISA will not do. Even if the peptide had a previously unknown interaction with another peptide useful in a new analysis technique, this unknown (natural) interaction would still be considered obvious and lacking patentable inventive concept (though, I could make some good arguments).
SSeems one of the few remaining strategies is to claim a highly specific use or analysis, so that not monopolizing the natural phenomenon would weigh heavily for patent eligibility. Arguments could be made that the particular method has aspects making it not "obvious to try".
September 10, 2014
Google to Make Us All Old
Interesting overview. I had almost forgotten this Calico initiative. Will it be a success? Of course. But the goal was not lofty - “focus on health and well-being, in particular the challenge of ageing and associated diseases." All they have to do is provide focus to a diverse group of scientists.
Ironically, the article confirms that the project is already going in the opposite direction. There is not a focus, but a plan to conglomerate diverse technologies and resources (like the "fully integrated" biopharma failures of the past). It is true that no one discipline can solve the problems of ageing. More than money and desire, I think the key variable is - Timing. Are all these fields of computation, biology, (medical ethics) and pharmacology mature enough to fuse into a grand theory? I doubt it.
But it is fun to have a caprice when you have money to throw around. Now, I know what all those patent attorneys Google hired last year are doing. They are waiting around the virtual water cooler wondering how they will convince a patent Examiner that a grand theory is eligible subject matter for patent protection.
September 9, 2014
Open Floodgates of Loser Pays - Yet
No Open Floodgates of Loser Pays - Yet
The holdings in Octane Fitness v. Icon Health & Fitness, 12-1184, and Highmark v. Allcare Health Management Systems, 12-1163, are not opening the floodgates of fees for winners of Federal Court cases. Loser pays in the dominant system in most of the rest of the world. http://www.bloomberg.com/news/2014-04-29/supreme-court-eases-rules-for-winners-to-collect-patent-fees.html
In HOMELAND HOUSEWARES v. SORENSON RESEARCH, the defendant was found in a summary judgement to infringe Prevention of void-based-irregularity formation in thin-wall, injection-molded plastic product (https://www.google.com/patents/US6599460?dq=6,599,460&hl=en&sa=X&ei=XhAPVN_tK8aH8gHv24GgBg&ved=0CB8Q6AEwAA). Defendant filed a appeal, including petition for legal fees, based on facts immaterial to the holding. Fees were not awarded on a technicality, and on the opinion Appellant's Appeal was not adequately frivolous.A simple Appeal had cost one party a quarter million dollars. Too bad we can have no expectation that winning parties will avoid such costs any time soon.
September 8, 2014
Best New Antibiotics May Be Protecting the Old Antibiotics
The search for new antibiotics has been dismally slow. Pharmaceutical companies may be having more success rehabilitating old antibiotics. Merck is studying the intravenous β-lactam antibiotic Imipenem in combination with Cilastatin and its Relebactam. The FDA has fast tracked their application.
Cilastatin inhibits the human enzyme dehydropeptidase, that can destroy lactamases in the kidney. This helps the pharmacokinetics of the Imipenem.
Relebactam is not actually an "antibiotic" but inhibits bacterial lactamases from destroying lactam antibiotics. So, Relebactam helps retain lactam antibiotic activity as it attacks bacterial cell walls.
Next thing we know, we will all be using the first beta-lactamase antibiotic again - penicillin! And so the world turns.
September 4, 2014
Disney in a Tussle Over Ears of a Dead Mouse
The Disney trademark shown in the article is number 73717780 ( http://tsdr.uspto.gov/#caseNumber=7371778&caseType=SERIAL_NO&searchType=statusSearch in international class 025 clothing with a description of hats.
You judge if there would be a likelihood of confusion. Not sure why Disney did not raise their trademarks in the entertainment class 41, except the designs are less similar. For example, see: http://tsdr.uspto.gov/#caseNumber=85705877&caseType=SERIAL_NO&searchType=statusSearch
IIt seems there might be a small amount of confusion, and I believe the deadmou5 mark may have been intended to get some publicity from Disney. Still, (unusual for me), I do not have a strong opinion either way, absent more facts than I have. I just know, I would not want a tussle with Disney over one of their marks.
August 31, 2014
Are Electrolytes the "Cure" for Ebola?
Based on the comments of Mr, Ribner, the cure for ebola is usually standard supportive care. The reason fatalities are so high in Africa is that patients often start out in poor health, are not routinely evaluated by standard simple lab tests (electrolytes, CBC, albumin), and do not have standard infusions available.
This reminds me of the story about cholera. Vibrio cholera mostly kills by action of cholera toxin that allows chloride channels to release chloride ions uncontrollably, followed by associated cations and water into the gut. The result is perfuse rice water stools, removing water and electrolytes from the patient. Some years back, researchers found that even without antibiotics, the mortality rate for cholera was reduced many fold by simply providing the patient with a source of rehydration, electrolytes, and glucose; even while the diarrhea continued. See : http://rehydrate.org/ors/rice-based-ors.htm
With ebloa, things are a lot more
complicated. Still, there is the similarity that survival may mostly
require maintenance of proper blood chemistry. Yet, a vaccine would be
nice. What do you think?
What do you think?
August 29, 2014
Your HCV Treatment Quality-Adjusted Life Year Cost Effective?
Is Your HCV Treatment Quality-Adjusted Life Year Cost Effective?
Does Soldavi provide a cost effective alternative to other treatments at current prices? Apparently, it costs four times more for Soldavi than previous treatments, while providing 1.6 quality-adjusted life years over standard care without drugs, and actually less benefit to the average patient than the IFN/ribavirin guided with genetic marker customized medicine. Near as I can tell, Soldavi provides 1.6 years for $100k, while IFN/ribavirin in identified patients provides 2.8 years for the same price as treatment without drugs.
12 weeks of Sovaldi in combination with ribavirin (SOF/SMV) costs approximately $150,000, with sustained virologic response (SVR) rates ranging from 89% to 100%. SOF/SMV yielded quality-adjusted life years (QALYs) of 14.69 QALYs.
No drug treatment (symptom care only) strategy was associated with a cost of $38,747 and 13.10 QALYs. The strategy using viral genotyping first and then adjusting the duration of combination therapy based on genotype was associated with a cost of $37,263 for 15.89 QALYs. http://onlinelibrary.wiley.com/doi/10.1002/hep.510300518/abstract
A QALY is is additional years of life, reduced by any suboptimal life quality. See,
So, it seems the Soldavi treatment regimen provided benefits of 1 QALY for about $68k. Years ago it was said that if you could not get a QALY for $50k the money was better spend elsewhere. But is Soldavi a better deal than alternatives? The Soldavi regime has the additional benefit of being more effective at clearing the virus from patients, making them less infections. What is the value of the reduced transmission to other patients (or the eradication of HCV from the planet)?
This informal analysis compares separate studies, introducing many errors. However, for those patients with gene analysis showing higher expected efficacy for IFN/ribavirin, this have the best cost/benefit ratio. What do you think?
August 25, 2014
siRNAs May Offer Ebola Protection
It is interesting how far we have gotten with siRNA and liposome technologies. The combination should apparently work to stifle Marburg viruses infecting or residing along the bloodstream. siRNAs against the virus polymerase are encapsulated and injected into the patient days after infection with a lethal dose. It is not a cure, but inhibits the virus to such an extent that the lethality is reduced substantially.
Similar work was successful in primates infected with Ebola in 2010. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60357-1/fulltext Small interfering RNAs (siRNAs) targeting the Zaire Ebola virus (ZEBOV) RNA polymerase L protein formulated in stable nucleic acid-lipid particles (SNALPs) succeeded in protecting macaques.
The liposome technology is fascinating, with multicomponent formulations having different functions at different phases of manufacturing, adsorption, and cytoplasmic release. The incorporation of fusogenic lipids such as dioleoylphosphatidylethanolamine (DOPE) improved the efficiency of endosomal release by encouraging fusion events between the liposomal and endosomal bi-layers solving the problem of endosome release. http://tekmira.com/docs/Protiva_Heyes_et_al_2005.pdf
Here is a patent for liposomes by Tekmira Pharmaceuticals who made the medicine in the article. https://www.google.com/patents/US20110256175?dq=20110256175&hl=en&sa=X&ei=34H4U5L1HJbJsQSg0IA4&ved=0CB8Q6AEwAA
TToo bad such technology probably would not work in AIDS, as these technologies do not seem to cure, and HIV hides in certain reservoirs not necessarily accessible by a simple injection.
August 11, 2014
Trolls Will Not Be Jousting at Windmills
Patent Applications. It is ridiculous to think someone is going to come out of the blue with five wind turbine patent applications that will ISSUE with unavoidable valid broad claims. If they did, that would be great! What a contribution to wind power and reduction of carbon foot print.
It is not going to happen.
These are APPLICATIONS (can you tell this has got me excited?). They may start with grandiose original claims, but will be whittled down to focused claims (particularly with the pressure on Examiners generated by this publicity) easily engineered around, if they issue at all.
Further, there are no damages before issuance of a patent unless the infringers receive actual notice AND the claims issue essentially as originally filed. I believe there is also no possibility of triple damages, e.g., for intentional infringement before the patent issues.
"Infringers" will have time to make adjustments before issuance of any claims. Then there are post grant procedures to challenge the issued patent claims:
Post grant review (PGR within 9 months of issuing - http://www.law.cornell.edu/uscode/text/35/321 )
Inter partes review (IPR - after 9 months http://www.uspto.gov/web/offices/pac/mpep/s2609.html ), and
Ex parte reexamination (any time after issuance - http://www.uspto.gov/web/offices/pac/mpep/s2209.html).
Expect that the issued claims will have to meet tests of fire challenging their validity at the US Patent Office.
If valid claims ultimately issue, infringers should pay reasonable royalties to practice, if they desire. Alternately, the claims will NOT be as broad as the author is suggesting and likely can be engineered around. The wind world is not ending.
AIDS a Cure for MS, or AIDS Cure a Cure for MS?
Doctors reviewed large populations of AIDS and MS patients to discover that they had treated only one HIV/AIDS patient for MS. Typical MS prevalence is very low but the two populations were large enough to notice a disparity. See full article at - http://jnnp.bmj.com/content/early/2014/07/16/jnnp-2014-307932.full. Then, they noticed AIDS patients with MS had symptoms reversed when treated for AIDS. Hmmm. Wouldn't be the first time MS had been inhibited by an antiviral - IFN-beta (Betaseron).
Doctors hold open the possibility the infection may be inhibiting MS. For example, the AIDS immunosuppression may be inhibiting autoimmunity. The hypothesis does not seem to fit for me though, because the MS was further suppressed once the patient started taking the anti-AIDS drugs.
There probably was no bias in that the control group was not limited to a population at high risk of HIV infection.
I praise the UK system for having reviewable records. I doubt we could do the same in the US.
August 9, 2014
"The Invention Includes" Is Admitting Tooo Much
Pfeeew, that was a close one. I thought written description might be going the way of the European added subject matter rejections where they require express unitary descriptions of all claim limitations in the specification. However, the day was saved by having the subject matter in the original claims (said to be part of the original specification?) and some respect for what one of skill would have known from reading the totality of the application.
See the Court case at:
What bugged me is that even one Not skilled in the art would know the sensors were not necessary to the function of the invention (or novelty/non-obviousness), yet the lower Court invalidated the claims based on the position that no reasonable jury could have found that the inventors were in possession of the concept of a device not requiring sensors. This was based solely on the statement in the specification that "the invention includes" sensors. Sheesh. The Court thought the inventors were unable to run the machine without sensors just because the application included sensors as part of THE "invention".
Lesson - have a broad array of claims in your original (provisional) application.
Lesson - never describe the limits of "the invention" in your specification. For example, "embodiments can include ..." may be better.
August 5, 2014
Strategies Combining New FDA Companion Diagnostic Guidelines with USPTO Patent Eligibility Guidelines
The Food and Drug Administration (FDA) has just released Guidelines for In Vitro Companion Diagnostic Devices (IVDs). An IVD companion diagnostic device is an in vitro diagnostic device and method that provides information essential for the safe and effective use of a corresponding therapeutic product. The FDA intends to require separate marketing applications for a therapeutic product and the IVD intended for use with that therapeutic product.
See FDA Guidelines at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf
The United States Patent and Trademark Office (USPTO) has previously issued Guidelines for Determining Eligible Subject Matter for Patent Protection. Ineligible subject matter includes, e.g., natural products, such as natural peptides or nucleic acids and their sequences (Myriad decision), correlations between drug metabolites and effective dosing regimens (Mayo decision), or expert systems that suggest treatments (Smartgene decision). See:
Myriad - http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf
Mayo - http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf
Smartgene - http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1186.Opinion.1-22-2014.1.PDF
Well, this is quite a mine field of FDA and USPTO prosecution to go through, e.g., if you have a biomarker associated with a disease and you want some protection in the market place.
To provide patent eligibility at the USPTO, claim your biomarker in compositions and methods using a combination of aspects that direct the Examiner away from an ineligible subject matter rejection:
1) Claim the marker in an unnatural form, e.g., as a cDNA, linker modified, reporter modified, bound to a ligand/receptor.
2) Focus on the best mode, or your market plan. Do not try to claim the generic concept.
3) Claim the natural phenomenon (biomarker/correlation) in combination with a machine and/or transforming method. This works best if the machine or transformation provide a solution to a problem addressed by the claim, and are not just an extra-solution activity.
4) Preferably, the elements or steps added to the natural phenomenon are the least obvious way to detect or measure the phenomenon.
Once you get past the patent eligibility (35 § 101) question you will still have to defend against obviousness (35 § 103) rejections at the USPTO.
Once you have a patent from the USPTO for compositions and methods for determining if a patient has your biomarker, you may still have to deal with the FDA. If the method (e.g., assay) is essential for the safe and effective use of a therapeutic product (or to be used in a decision whether or not to use the therapeutic), the FDA will require submission of an application validating the method and associated device. You will be required to, e.g., document the correlation with a patient population, specificity, accuracy, sensitivity, robustness, linearity, range, ruggedness ... This can be a difficult license to obtain but is also a barrier to entry for competitors.
The good news is that even if you have to narrow your claims to get a patent, and competitors can engineer around your claim scope, you can still obtain large competitive advantages. If competitors engineer around your patent, they are likely going to settle on a second best method or device. Typically, the competitor engineered alternative will be obvious in light of your application, so they would not be able to obtain a patent. If their engineered alternative is a patentable improvement on your claimed invention, they would have to license your generic concept in order to practice their species improvement. No matter how you look at it, you would be in a better position than the competitor.
Even if a competitor manages to get past the patent barriers to your market, they may still have a huge obstacle in licensing at the FDA. If you have a patent on a new therapeutic composition, you may qualify for a period of exclusivity, e.g., beyond the patent term to compensate for the inability to use the invention during the FDA licensing process (Hatch-Waxman exclusivity period). Sorry to say, there is no FDA exclusivity periods for medical devices.
Finally, depending on the risk involved to patients, a competitor with an identical device or method may be required to file an FDA application establishing their device is "substantially equivalent" to your device. If their device or method is different, they may be required to file a new medical device license application from scratch, with associated cost and delay.
So, depending on the particular facts of your case, strategies are available to gain market place advantages for your biomarker, therapeutic, and/or medical device. To determine a strategy best for your situation, contact a professional with knowledge of FDA licensing and patent prosecution at the USPTO (e.g., contact me at Baker@BioPatent.com)
August 3, 2014
TEVA Accused of Evergreening - Good for Them
It seems TEVA's initial patent for Copaxone (glatiramer acetate) for treatment of multiple sclerosos (MS) is about to expire. See glatiramer acetate for treatment of CNS diseases - https://www.google.com/patents/WO2001093828A1?dq=intitle:Glatiramer+intitle:acetate&ei=HvjcU8ehGMPC8QGb4IDoCg&cl=en .
TEVA has tried everything to retain control of Copaxone from generics, including going to the Supreme Court (http://sblog.s3.amazonaws.com/wp-content/uploads/2014/04/CA-Alend-draft-petition-FINAL_for-Wilson-Epes.pdf ).
Worst of all, they have even tried to improve the drug, dosing, and processes, to remain competitive in the market. Funny, drug companies can get a bad reputation for improving their drugs. Evergreening.
I was reading an article on the TEVA roll out of a new formulation and dosing regimen. One patient noted:
"As a consumer, I dislike this kind of thing more than I despise needles. While I don't know what Teva's development schedule for this product has been, but as a patient, I have questions. I wonder if it could have introduced this new product, with its advantageous dosing, years ago. However, it's strategically better to extend the new patent on this particular variation as far into the future as possible and not overlap with the classic seven-shots-a-week version, and also move patients onto the new and improved version as soon as possible."
I do not know TEVA's motivation for their product roll out timing of the improved product. However, TEVA did expedite prosecution of the patent (starting with a provisional application in 2009 and issuing in 2010), and had the product available soon thereafter. See: https://www.google.com/patents/US7855176?dq=WO2011008274&ei=9fvcU5KkJual8gHJuoGoBw&cl=en However, they have now converted 60% of their MS patient base over to the new (and patented to 2030) formulation. Is this evil evergreening?
Is it a bad thing when a company invents a drug that reduces relapses of a disease and then (later) makes improvements? Is it an evil plan when the inventors continue research in their area of expertise and develop new and non-obvious improvements?
Soon, several other drug companies can begin marketing copies of the original Copaxone. (The drug being a randomized series of four amino acids, it is questionable that the copies will actually be identical to the original.) That is their right. And patients can continue taking the old version at a lower price. In fact, TEVA has developed more efficient methods of manufacture (WO2013065071A1 - https://www.google.com/patents/WO2013065071A1?cl=en&dq=WO2013065071A1&hl=en&sa=X&ei=xvncU-3UPIr38AGtiYDICA&ved=0CB4Q6AEwAA ), so they could even provide the original version at a lower price than the other generic sellers, or help reduce the cost of their improved formulation.
Seems like all good news to me. Too bad the general public does not seem to know that when a patent expires it goes to the public domain and anyone can practice it. One can not extend a patent another 20 years by putting the drug in a new excipient (e.g., buffer). Typically, such a new claim would be old or obvious and the patent invalid. If the patent is valid, we should thank the inventor for the improvement. Buy the improved product, if it is worth the extra cost over the old version.
Thank You Evergreeners!
By the way, I established the shelf life of Betaseron and occasionally helped technicians in manufacturing. It is still perplexing to me that an antiviral has a mode of action in an autoimmune disease, like MS. That crazy network of cytokine interactions.
July 25, 2014
Tylonol Does Not Cure Back Pain - Who Knew?
Good study population size, so that makes the study pretty convincing. Bad end point though for an analgesic study - median time to recovery. Seems strange an analgesic being evaluated as a cure. Also, the study did not include a group that did not receive any treatment, i.e., no placebo patients. The data did not include short term relief from the pills, only the end point criteria of pain-free for seven continuous days.
The study was published in The Lancet July 23, 2014
I used to have lower back pain, mostly from an imbalance resulting from a construction injury. The pain went away for good once I started exercising 3 times a week. Biking seemed to help the most.
July 24, 2014
India Not Too Unfair - Evergreening of Patents is a Myth
I have never had a bad time patenting in India, but for some minor administrative glitches, to be expected. Nothing unfair.
It is annoying when foreign countries steal inventor's intellectual property in the name of saving those that can not afford the product. If it is so important, why doesn't the foreign government pay for it? Easier to steal it, I guess. However, India has only exercised the compulsory "licensing" clause once, that I know of.
In my opinion, there is generally no such thing as "evergreening" (repatenting) of a drug. If a drug company has a pioneering product nearing the end of the patent term, anyone can practice the product after it expires - this, even if the company manages to receive a new patent, e.g., with the drug in a new buffer or time release form. That does not evergreen the pioneering patent. Further, the new buffer formulation for the drug is generally obvious and should not ever be granted. There should be no such thing as evergreening in a standard patent system that is functioning properly.
July 21, 2014
Jets without Pilot Windows
OK. Everyone liked the Airbus bicycle seats so much, I decided to also show their other great new idea: jets with no window for the pilot. See patent application at:
I am a private pilot and ever since GPS moving maps commonly entered cockpits (about the last 5 years) pilots are looking out the window less and less. The GPS flat screens even have a lady who yells at you and tells you when another airplane gets within 5 miles of you. A screen pops up and shows you where the other plane is.
Private pilots are actually trained to fly the plane without looking out the window (even before moving maps using "steam gauges": attitude indicator, altitude gauge, turn coordinator, heading indicator; running on gyroscopes, and such) - see, old Cessna instrument panel: http://www.biopatent.com/panel.html. This training is in case the pilot ever flies into a cloud (what are the odds?). So, what I am saying is, even private pilots in small planes are looking out the window less and less.
Apparently the pilots of airliners are also not looking out of the front window, e.g., see Ariana 214 crash in San Francisco (side story - I was on a US Air flight just hours after that crash and our jet almost went off the shorter alternate runway at SFO while the firefighters were goofing on the main runway). If you look out of the windscreen and see that the runway threshold seems to be going higher and higher, you are not going to make it to the runway - is that too complicated? All you have to do is look. But the pilots were letting the computer fly.
Actually, even my small rental Cessna has a moving map and autopilot that could allow you it to go on an entire flight without a pilot, right down to the approach. However, it requires a pilot to flare and land softly on the runway.
So, windows are on their way out ... and so are the pilots.
Avoid Admissions of Claim Scope in Your Application
"A tension in drafting a patent application to improve the chances of actually receiving a patent and drafting the application to ensure that the resulting patent claims are not construed narrowly based on the specification embodiments."
See case at:
I do not see the tension, or even a problem. I have never experienced a time when I convinced an Examiner to allow claims because a feature in the claims or in the specification was "essential". One can not back track from an Admission. I just reviewed an inventor's disclosure (his version of a provisional application) and removed all references to "necessary", and "required" aspects in my filed version.
How about trying this - put the "essential" aspect in a dependent claim? The independent claim can still have broad scope. If unknown prior are arises without the essential feature, put it in the independent claim from the dependent claim (shouldn't even be a written description rejection, even in Europe). On top of it, the case may be strengthened by an expert declaration confirming the essential status, if it ever came to it, and it almost never would as a practical matter.
Not that I am a litigator. Maybe I am missing something.
July 14, 2014
Spicy Eye for Alzheimer's Dx
Curcumin is a bit of a wonder molecule (antibacterial, antioxidant, cancer reducing, blood clotting, makes messy stains in my kitchen). It is even cited (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2781139/ ) as a Treatment (not just diagnostics) for Alzheimer's.
I did some searching, and found the patent for imaging with curcumin (http://worldwide.espacenet.com/publicationDetails/originalDocument?CC=WO&NR=2011119602A2&KC=A2&FT=D&ND=3&date=20110929&DB=worldwide.espacenet.com&locale=en_EP ), and another article on more bioavailable curcumin ( http://www.ccsenet.org/journal/index.php/jfr/article/view/36189/20874 ).
The whole turmeric and curcumin thing raised a big ruckus years ago when patent applicants tried to claim methods of using them to treat or prevent any number of illnesses. India, for one, complained the ancient practice was being stolen. Of course, patenting rules foreclose patenting of something not new, but that seemed to go over everyone's heads.
Still, this all leaves open the question of how the apparently oral curcumin actually crosses the blood/brain barrier.
July 11, 2014
Put Up Your Dukes
What is up with Duke University? They have a registered trademark design that
includes the word DUKE in the international class 025 for clothing. http://tmsearch.uspto.gov/bin/showfield?f=doc&state=4807:qimqxg.5.33
There are at least 60 live trademarks in the alcohol class (033) that include Duke of terms that sound like Duke. For example, DUKES FAMILY VINEYARDS, THE DUKE MUNICH DRY GIN. and THE DUKE (whiskey http://tmsearch.uspto.gov/bin/showfield?f=doc&state=4807:qimqxg.4.2).
Why is it Duke U. the one raising this ruckus? There would be little likelihood of confusion between Duke bourbon and Duke U. t-shirts. Duke U. is probably trying to get leverage for a settlement with Duke bourbon promising to modify the trademark, and stay away from clothing.
One thing is for sure, Duke Bourbon got more money's worth of advertising out of this than their litigation costs, so far.
July 7, 201
Intent to Use Trademark Application Can Not Be Used to Hold a Mark While You Look for Inventors
There has to be a process in place to screen out trademark filers with no real current intent to actually use the mark, e.g., on goods. A hope is not good enough. The goods should come first, not the mark. "What will I name my goods?" Not, "What goods should I put this cool mark on?"
It only costs $325 to file a mark. After the mark is found appropriate and not conflicting with a confusingly similar mark, you have 6 months to file a Statement of Use, showing evidence that you have used the mark in association with sale of the goods. Various 6-month extensions ($150 fee - http://www.uspto.gov/web/offices/ac/qs/ope/fee010114.htm#tm) are available to continue swearing you have a bona-fide intention to use the mark.
You can see that a person without a product but only the trademark application can shop around for years trying to find a product or partner. By paying minimal fees the applicant can hold the cool mark trying to keep others from using it.
This abuse may be minimized a little by a recent case Lincoln National v. Anderson ( http://e-foia.uspto.gov/Foia/ReterivePdf;jsessionid=B58B29D60C54D908FF42EFAE0F6B5A8F.prod_cidmext_jboss1_jvm2?system=TTABIS&flNm=91192939-02-21-2014 ). In Lincoln, the trademark applicant for "FUTURE" was shopping for a licensee, not a product, and lost his rights.
Worse yet, such behaviors can come back to haunt you. Even if you eventually get the big money licensee or partner and start actually selling goods with the mark, the mark could be taken away if the facts show you did not actually have the necessary intent AT THE TIME YOU FILED.
Why Does Big Pharma Have a Bad Reputation, After It Has Saved So Many Lives?
I don't think the bad image is due to lack of advertising. Actually, to the contrary, I have heard a lot of criticism in the media of the money pharma spends on advertisments.
Ironically, the big problem is that we help sick people. But ... we have to charge them money Years ago, Genentech had a big summer party for the employees and actually hired the Rolling Stones. What an uproar. "Taking money from sick people and having a big party!" Now Genentech's summer party is always a big charity event - Genentech "gives back". If Pharma makes any profit, they can not spend it without being accused of spending blood money.
Although successful pharma makes a nominal profit, considering the risk, the accusation is always that the profits are excessive. The most hurting example is when pharma charges $1000 of a dose that costs $75 to manufacture (not counting the expense of the research to discover and develop the drug, and THE EXPENSE OF THE NINE OTHER FAILED DRUGS THAT NEVER MADE IT TO MARKET). No one wants to pay for research or failures (especially countries that have no productive research of their own) so they vilify pharma so they don't have to feel like they are stealing.
Of course, politicians are the big heroes that show how humane they are by asking questions like "why are drugs cheaper in Canada?"
What to do? Let those who will listen know the NET PROFITS of the AVERAGE drug company (including small ones and ones that FAIL every day (sorry about the yelling)) are not out of line. Ask those who complain about drug prices to see if they can do a better job, if developing druigs is such a gold mine.
Something that might help ... elect politicians that have the real facts. I am a member of a general aviation group (Aircraft Owners and Pilots Association) that has only 200,000 members but we manage to have significant influence in matters of importance to us. How many voters are there in the pharmaceutical industry?
Where are the Biotech Jobs, Really?
A recent article ( http://www.bostonglobe.com/business/2014/06/18/mass-leads-nation-life-sciences-jobs/MOuNJRZsdk3bNtcGnTvtVN/story.html ) states that the "undisputed leader" " Mass. leads nation in life sciences jobs", and I was quite surprised. Had the combination of federal taxes, state taxes, anti-business climate, excessive regulations, and arrogant attitude, driven all the biotech jobs out of California?
My wife's previous biotech employer pulled out of Cal. and went to more friendly Germany.
Looking into it, I see that California has three times as many biotech jobs as Mass, and Mass is actually number 3 (or 6?) in terms of total jobs, after at least Illinois (http://medcitynews.com/2012/06/these-7-states-really-know-biotech-and-probably-have-jobs/ ). San Francisco Bay Area and greater Boston each have about 50,000 biotech jobs. But Cal. also has San Diego.
SSo ... Mass has the most biotech jobs PER CAPITA.
I am not so sure Mass. is the "undisputed leader" in biotech. Reminds me of the cold war (not that SF is at war with the Boss) when the Soviet Union had the "biggest" everything, but was that heaviest, longest, densest, tallest, most massive, most volume, or most expensive and least functional (airplanes that were only good for propaganda)?
July 3, 2014
10 Problems with 3D Printing
The universe is in balance, and there are pros and cons to everything. It is good to think of these things in advance and avoid problems without having to experience them.
For example, the issues of toxic residues and microenvironments for bacteria on 3D printed dishes can be resolved with higher resolution printing and appropriate choice of printing media. First generation printers will be energy hogs, but they will become more efficient with time; and there are trade offs, such as not requiring energy to transport the item to the end user.
The article raises several legal issues. Copyright and patent licensing issues are already being addressed for legitimate sales; and there will be pirates, as in the music and video industry.
I believe the problem number 8 regarding printing of drugs is misstated. Although drugs (e.g., pills) may be printed (replacing the pill press), the printer requires starting media already containing the drug. See, e.g., https://www.google.com/patents/CN103393543A?cl=en&dq=3d+printing+of+drugs&hl=en&sa=X&ei=3HS1U8-oM9GWqAaU4ILQCg&ved=0CB4Q6AEwAA. The 3D printer will not carry out reactions of pro-drug starting materials (which themselves are often difficult to obtain).
The printing of tissues and organs can be a great thing for many patients. Of course there are the ethical issues (like the old proposal to transplant pig hearts into humans (not for those of the Jewish persuasion). Hold the dog muscles in my new toe! The good news is that innocuous printed scaffoldings can be populated with stem cells from the same patient to receive the organ, to avoid physical and emotional rejection of the body part.
I will keep an eye out (not literally) and will immediately send a cease and desist letter if ANYONE tries to 3D print a copy of my beautiful nose.
I. June Entries
June 30, 2014
Supreme Court is Confusing Obviousness with Ineligible Subject matter
You can not patent a natural phenomenon, or an abstract idea (such as the Pythagorean theorem). However you can patent a method (see 35 § 101) .
The analysis in the article and in the Mayo holding is totally screwed up (a legal term of art). The article says:
" If a particular software patent’s claims can be distilled to a general concept that was in existence long before someone thought to implement the concept in software, there is a good chance it is an unpatentable abstract idea. ... the only way to convert these otherwise unpatentable abstract ideas into a patentable invention is to show something else in the patent’s claims that make it a new invention.
Excuse me, but this is 35 § 103 OBVIOUSNESS analysis and § 102 NOVELTY analysis! The method in the claims deemed patent ineligible is not a natural phenomenon, or an abstract idea. It the method section 101 eligible subject matter unpatentable for obvious under section 103.
A method of taking seeds from a cotton ball by carding it through brushes is not an abstract idea, it is the the basis of Eli Whitney's cotton gin. What is left to patent if everything is an ineligible "abstract concept"? IMHO, the SCOTUS should get out of the business of analyzing intellectual property in light of the constitution and laws until they get registered at the PTO.
Aereo Trhough the Heart - Off Air Recording Service is "Public Performance"
There goes SCOTUS running on their gut feelings again in IP law, when the facts do not support the holding. SCOTUS has a gut feeling Aereo is using technicalities to get around the law (and they are). But this is no reason to get back at them by intentionally mischaracterizing the facts.
"Breyer said that Aereo's activities are substantially similar to that of cable companies." However, Aereo is not broadcasting programmed material like a cable company. Their procedures are more like a recording a show for later playback, like I do from an attic antenna at my house to a hard drive on my computer for later viewing. What? Are they going to throw me in jail now for recording and later viewing off the air waves?
"Aereo still transmits copyrighted programs to a large group of people [at different times watching different shows] who are unrelated and unknown to each other, and they constitute "the public," Bull ... oney! Aereo relaease a program to a viewer who elected to store it for later viewing. The viewers watch their show when they decide to present the show to themselves. Aero never transmits a show to a large group of strangers.
What a twist of the facts SCOTUS used to provide the outcome they felt was more "fair". SCOTUS should remember their place is to apply facts to law, not to make up facts to fit the legal outcome they desire.
Inhalable Insulin Approved By FDA
Apparently, fumaryl diketopiperazine (FDKP) enhances passive transport across cell membranes, and eventually into the blood stream. See http://professional.diabetes.org/Content/Posters/2004/p484-P.pdf
See patent at: http://www.google.com.ar/patents/US20040077528
BioPatent behind the story.
June 27, 2014
Do lab technicians still pour their own gels? I suspect they are all retail products now days. It should be a right of passage to make all new technicians pour a PAGE gel.
Apparently, the negative control rat population was small and number of spontaneous tumors, though known to be high, was not evaluated. Positives were considered across a variety of different tumor types.
I suggest the article should not have been reprinted, but the study should be redone with a more statistically valid population of test animals.
As a side, has anyone suggested a mode of action for carcinogenesis of a variety of different tumors when EPSPS (glyphosphate resistance peptide) is EATEN and digested?
At risk of not being PC, I think the issue of political "fairness" does not
belong in science. It makes sense to randomize a population of males and female
animals (humans) for end game study.
However, if you are doing a study of a small molecule activity on a cell, do you want to be required to do the study on a set of female cells (HeLa) and also on a set of male cells (SheLa?)
Who is for politicians and journalists setting the rules for scientific research? Raise your hand.
Great idea to get the information out in the market place, so buyers can make informed decisions on relative efficacy and cost benefit ratios.
Great idea to make the end user
feel some of the pain in the pricing.
If they want something special, let them pay for it.
I know patients in the
The one thing the
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:
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:
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
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.
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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