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Gary Baker, Esq., M.T.
BioPatentSm IP of Quinelaw
Biotech and Intellectual Property
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Many articles talk about what happened, without touching on the how or why. This blog is intended to fill in legal, technical, or political background information left out of the stories.
My topics are varied (auto mechanics, molecular biology, airplanes, patents), so please scan through to topics you care about. Please read hyperlinked stories, then my insightful comments!
The communications on these web pages are not intended to create an attorney-client relationship. Do not act or rely on any information in on these web pages without first seeking legal advice from competent counsel. This material is intended for general information purposes only and does not constitute legal advice.
January 19, 2018
All Limitations in a Reference Does Not Prove Anticipation
All limitations in one reference is not enough for anticipation of a claim. The limitations must be arranged as in the claim; otherwise, the Examiner should move on to an obviousness rejection, if a Reasonable one is available.
This is old law. For example, in Net MoneyIN Inc. v. VeriSign Inc., 88 USPQ2d 1751 (Fed. Cir. 2008) - Prior art reference, in order to anticipate under 35 U.S.C. §102, must not only disclose all elements of claim within four corners of single document, but must also disclose those elements “arranged as in the claim”; this requirement, more accurately understood to mean “arranged or combined in the same way as in the claim,” applies to all types of claims and refers to need for anticipatory reference to show all limitations of claim arranged or combined in same manner recited in claim, not merely in particular order.
January 3, 2018
Life is So Simple that We are Running Out of Drugs to Discover
Peak Pharma. We are simply running out of pharmaceutical targets, as the author would have it. There are too few ways to cure diseases. The pharmaceutical market is becoming like peak oil. But the author fails to note what happened to the alleged peak oil of 2000 after fracking showed up. And … did the whalers experience peak whale oil before their replacement with petroleum products?
It is true that the number of small molecules found to active proteins of interest in arrays that been decreasing. Many (all) were surprised at the small number of active proteins encoded in the genome.
That pharma is mining only about 500 active proteins may be accurate, but active sites in peptides are not the only targets available in animals. Simply enhancing/inhibiting in situ active peptides only represents a small fraction of pharmacological strategies. There are targets and modes of action that are yet to be imagined in the minds of [wo]men. For example, who was considering strategies based on epigenetics or CRISPR 20 years ago?
The article starts with the suggestion “[n]early all regulatory submissions win approval ….” [So available drugs are being claimed too fast?] This can’t be true. Even the hyperlinked article shows only 10 to 20% clinical study success rates.
The “day will come when the average new drug candidate is a money loser.” Shouldn’t take tooo long. There never was a day that the average drug candidate made money.
“Get used to this. Moderately-priced mass-market drugs will disappear. Or rather, they will go off-patent and become generics. With no R&D expenses to recoup, they will become cheap commodities …” Good. We should be used to it already, because that is the way it has Always been, and was intended. How much does an aspirin cost?
“These developments are no kind of tragedy — drugs cannot do much more to lengthen human lifespan. Nor are these developments the result of a conspiracy or of unusual levels of greed. They are just the end-stage of the depletion of a resource.” Yay, the author said something really insightful. Big shocker for me. A journalist said the pharmaceutical business is not a sinister conspiracy. Imagine.
And I thought we reached peak journalism years ago.
December 11, 2017
Engine Covers Stop Shade Tree Mechanics
Anyone who stopped from doing auto mechanics because of the plastic cover on the engine clearly should have his/her tool set taken away.
I have done all my mechanics all my life. See - www.biopatent.com/cars.html. Initially because I was poor, and because it was a cool thing for teenage boys to do in 1970’s Missoula Montana.
When cars became computerized, I was worried that I could not continue working on our newer cars. It was a little difficult before Congress forced the car makers to standardize on board diagnostics (OBD). Now that you can get good OBDII blue tooth devices for $30 for reading on your smart phone, car computers are not a problem.
And, cars are still cars. V-belts have been replaced with serpentine belts, but they still spin water pumps and alternators. Transmissions still have oil seals that wear out. The biggest pain is that every cubic inch of space under the hood is now taken up with some part of some subsystem. It takes me 10 minutes to change spark plugs in my 1972 240z Datsun (Nissan to the uninitiated). I can see the whole engine in the engine compartment and wave my arms around along the sides of the engine. In my wife’s BMW, it takes 15 minutes to get the first spark plug out of the mysterious dark orifice inside the engine; that’s after 10 minutes to take off the mysterious the plastic engine cover.
By the way, when did plastic stop melting?
November 13, 2017
Auto Makers Not Sparing the Spare
Geez, went to buy new tires for my ’73 Datsun 240Z today and found that most the big makers no longer manufacture 14 inch tires. Finally got some from a Korean brand I never heard of. It’s not like I was asking for “white walls” for God’s sake. I guess I should stash a bunch of 14 inch tires in my attic in case they stop selling them enTirely.
Tires. My wife drives a fairly recent BMW. No spare. OK, I can live with the run flat tires. Was worried they would not roll well, but they do. Problem was, time to change them, no one would sell me just two. Some kind of product liability issue around a legal case a few years ago and the yaw control (stability) systems. And … of course the same tire with run flat cost Twice as much as the non-run-flat. And … It took some time to find anyone who had the size I needed.
Too bad that BMW has so much torque. Rear tires go too fast. Even with my mellow Asian wife driving. (Sorry about the statistically valid stereotype.)
November 6, 2017
Synthetic Islet Cells That Can Deliver Insulin On Demand, Without Electronics
Apparently, there are insulin-filled liposomes in a lipid vesicle superstructure – a synthetic “cell”. There are glucose oxidase enzymes that lower the vesicle pH in the presence of too much glucose. The lower pH causes changes in conformation of proteins in liposomes and the vesicle so that they bind each other, leading to exocytosis of the liposome full of insulin.
They mention subcutaneous administration, but there are obvious problems. Such injections may be more unsettling to patients than standard insulin injections. The depot of the synthetic cells probably would not deliver consistent doses, e.g., over a reasonably long time. There are antigenic sensitivity issues to consider.
Because of these problems, they seem to prefer administration through a “patch”. This solves most of the problems above. However, how would the glucose and insulin each cross the skin (sweat, microneedles, solvents?).
The approach is somewhat simple and ingenious. This may ultimately be a feature of a more complex approach wherein the problems of this system are solved, while the system solves some of the problems in treating diabetes.
November 2, 2017
β Amyloid Protein in Blood Causes Plaques in Mouse Brains
This caught me by surprise. A mouse producing amyloid-β protein (Aβ) protein apparently passed it on to the brain of another mouse through a shared circulatory system.
It would be interesting to read the actual Molecular Psychiatry article. I wonder how Aβ crosses the blood/brain barrier?
October 30, 2017
Back to the Past - DeLorean
Many of us may remember the DeLorean story. Still, this is a well done, brief overview of another American car that tried to break the mold.
October 27, 2017
Sugar, La La La La, La La, Diabetes, Cancer
There has been a lot of discussion lately about the network of interactions between sugar, fat tissue, diabetes, and cancer.
There was an interesting article about 6 months ago suggesting that bulky adipose tissue can become relatively anaerobic and stressed causing inflammation and to release cytokines. The inflammation may be damaging pancreas islet cells, leading to diabetes. Here, abundant sugar (from diabetes and diet) promotes Ras gene and anaerobic metabolism of glucose.
The article suggests the sugar and the anerobic metabolism may promote mutations in Ras (or vis versa?). Maybe the inflammation cytokines are involved in the promotion of Ras and cancer.
Oh, what a tangled web we weave when first we gobble down indian corn (the white tips first).
October 25, 2017
US Patent Office Accused of Being Too Easy on Antibody Claims
Hello? The USPTO does not have a habit of issuing broad antibody claims. In the old days, they were broad, but not recently. Particularly where the antigen or epitope is previously known.
Now, even though it is unreasonable, the U.S. and most foreign countries go against their own rules and only issue antibody claims, e.g., comprising the exact sequences of all 6 complementarity-determining regions (CDRs).
Of course, this is unfair to the inventors. It does not provide the inventors a scope commensurate with what they teach in their original specifications. For example, I have cited various journal articles that show that any one RANDOM amino acid change in a CDR would not be expected to destroy specificity and affinity. One of skill in the art could examine the CDRs and make multiple conservative amino acid substitutions that would predictably retain function in the antibody. For example, substituting a valine for an alanine in an alpha helix structure, e.g., on the side of the CDR away from the antigen. In reply, the Examiners make the argument (contrary to PTO guidelines and controlling case law) that one change in one CDR COULD change the affinity. [Maybe, with experimentation trying to destroy the antibody.]
Here, the Court held that the claim was not supported by adequate written description (invention was not in hands of application at time of filing). I have to admit I was surprised at first at the scope of the claim to any antibody that binds in any way at least one of two identified amino acids on a particular target epitope. For example, claimed subject matter included monoclonal antibodies that bind an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3.
However, written description can be adequate where the specification describes a representative number of species across the scope of the claimed genus. Written description is satisfied where there is a correlation between structure and function. This can be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties showing previously unknown epitope. I think this probably was done. There is a nearly 400 page application with tons of alternate sequences and 3D structures. Dependent claims included even more structures and functional interactions.
Sometimes, I have gotten the impression that the Appellate bodies feel the scope of the claim is more than deserved, but for different reasons than those on appeal. Maybe the Court was annoyed that the claim seemed to be directed more to a natural epitope than an antibody, or the fact the claim deemed to hang monoclonal antibody scope on functional limitations. Sometimes it seems the PTAB or Courts reject for a reason other than the reason of record. You know – gut feelings the claims are not deserved.
See patent at: https://patentimages.storage.googleapis.com/f0/ce/e0/fb2cfd824ee486/US8859741.pdf
October 24, 2017
Dem Bones. Cool and Ventilated Cast
I have broken a lot of bones in my life. I love this new design for casts. Skin can breath. And, it should not be hard to find a portal through which to scratch an itch!
Still, since I have broken bones in every quadrant, I hope my share of bones have been broken and I never have to try out the new device.
Hey … but how can all your friends find a flat spot to sigh their names?
October 23, 2017
New Standards Standards Coming Soon. Only Virtual Kilograms Will Have 1Kg Mass.
I had occasionally thought about the standards of measurement. The platinum meter rod, at a particular temperature. The 1 Kg weight. How many atoms are rubbed off these standard objects when they are cleaned, e.g., with a chamois cloth?
The new standards will apparently be mathematical constructs based on trend analysis, e.g., of standards and their allegedly identical copies dispersed about the planet.
Thank god they are doing this. From now on, Kellogg’s will have to stop cheating me out of that last corn flake in the 500 gram cereal box.
October 16, 2017
Pneumococcus Vaccine “Improvement[?]” is an Obvious Invention YEARS After Optimization of Original Vaccine
Pfizer was apparently granted a patent in India wherein the “patent is a mere addition of serotypes to the already established 7-valent vaccine and does not meet the inventive step requirement; it ought to have been rejected.” This is “merely a tactic to preserve Pfizer’s monopoly for many more years.” The vaccine costs “$10 a child, which isn’t accessible to most countries.”
Hmmm. If the new vaccine is not inventive, Pfizer should not get a patent for it. However, if the new formulation is a significant improvement, it must rationally be inventive. Alternately, if it is not a significant improvement, then why do the “Activists” care about the patent at all?
If the new vaccine saves more lives, this was a big motive for anyone to have invented it earlier. If the additional subtypes in the vaccine were so obvious, why didn’t, e.g., the government of India do the obvious thing and improve the vaccine? That would be mean if they didn’t.
If the vaccine is Not an improvement, who cares about it? And, Still, the existence of the modified new vaccine patent does nothing to stop anyone from practicing the good old vaccine, for free. The existence of the new patent does not provide a continued “monopoly” over the old vaccine. On the contrary, it is nice of Pfizer to dedicate the proven life-saving old vaccine to the world on expiration of the original patent.
I once optimized manufacture of a successful Meningococcus vaccine. We probably spent a billion dollars on it, and probably still haven’t gotten the money back (though lives were saved). When the 7-Valent vaccine is in the public domain, maybe India would be nice enough to produce it for $1 a child. That might make it an accessible priority to many more caring governments.
By the way, what are the credentials of an “Activist”? They seem to know a lot.
October 13, 2017
Equination Saved Us From Small Pox
October 12, 2017
Cold and Distant – The Rhinovirus Story
This article has an interesting history of attempts to formulate a vaccine against the common cold(s).
Vaccination against specific subtypes has long been known to provide immunity – against the subtype. What is the benefit of this? We are all immune to a wide variety of subtypes (from immunization due to all the colds we have had) but this does not stop us from getting sick a couple of times a year due to other subtypes, e.g., of Rhinoviruses.
There seems to be resignation in the scientific community that no universal conserved antigen could protect against the bulk of cold viruses. The article suggests there are at least 160 subtypes of cold viruses. There is hope that a vaccine with surface antigens from 50 subtypes could adequately protect individuals.
Why not include all 160 subtypes in the vaccine? Because the more subtypes, the more it costs to validate the manufacturing process and the consistency of the product. I wonder if the FDA could show some flexibility to simplify licensing for this special case?
Vaccines were one of the greatest inventions of all time. Ironic that they, by their nature, fail to adequately motivate businesse$ to develop new vaccines. It is hard to make money on a one-time course for which no one wants to pay more than a few dollars.
October 11, 2017
(PTO Reality Check) Obvious Optimization Rejections Require Facts
Obvious Optimization Rejections Require Facts Beyond Conclusory Statements Based on Hindsight-Generated Gut Feelings. This article and legal case discuss issues that seem to pop up in many applications.
The Examiner can find a prior art reference that is close, and the Examiner can get a gut feeling that the claims are obvious (in hindsight). Then, the Examiner waives his/her hands and says it is obvious to one of skill in the art to copy the claimed invention. This, without actually applying a logical rationale based on facts identified from the prior art.
From my perspective, the article and In re Stepan case (http://www.ipwatchdog.com/wp-content/uploads/2017/08/16-1811.Opinion.8-23-2017.1.pdf) seem to also fail to use facts to explain the holding. The Court accuses the Examiner and PTAB of alleging obvious optimization without articulating a reason “why” OSA optimization is obvious. Spit it out! What is the why? Is the prior art trying to solve the same problem? Does the prior art identify the general conditions of the claimed material and identify a problem solved leading to the claims? Importantly, does the prior art identify a RECOGNIZED Result Effective Variable (RREV) that can be varied to solve the identified problem? See, e.g., MPEP 2144.05 II.
If any answer is no, then there is no case for an obviousness rejection. It is not obvious to solve a problem not stated, and it is not obvious to adjust a variable not taught in the prior art as interacting to provide an identified desired result.
Obvious optimization rejections are even more unreasonable when the rejection requires One of Skill to optimize several parameters at once. I was a research specialist for many years. The greatest criticism was reserved for researchers running experiments trying to modify multiple parameters at once.
How can you tell which parameter is responsible for which change(s) in the experimental result(s)? Yet, an Examiner will say it is obvious to arrive at a specific formula with four ingredients in particular proportions, not found in the prior art. When was the last time the Examiner ran an experiment? One would never arrive at the claimed formula testing changes in all four parameters at once. No experiment can identify multiple optimized values. Alternately, if One of Skill were to optimize a first parameter, then go on to the second, and third, and forth, one at a time in series, there still would be no expectation the result would be the same formula of the claims.
For example, depending on the optimum for the first parameter, the optimum for the second parameter will change. The optimum for each succeeding ingredient will change, depending on the interaction with the newly identified optimum for the preceding ingredients. Depending on what ingredient is tested first, the optimum of other ingredients changes. There is no predictability, expectation of success, obviousness to try, or recognized result-effective result. The result would change depending on the sequence of experimentation, e.g., with no understanding taught in the prior art as to how the sequence of the research will influence the result. Still, Examiners Will Say It is Obvious Optimization to arrive at a complex formulation of several ingredients.
Not all these issues exist in the In re Stepan case of the article, but once I get started, sometimes it is hard to shut me up.
October 10, 2017
Ever Heard of the Classic Datsun 210ZX?
I still drive two (’72 and ’73) Datsun 240Z sport cars as daily drivers. Although they look cool, they are Not aerodynamic. I have added a front air dam and spoiler to the ’72, but in the SF Bay area, I rarely get going fast enough for aerodynamics to matter anyway.
So, the Datsun (Nissan) B210 was not a bad car, and did not need improvement. It looked like a mini 240Z, but was way less powerful but more economical.
Here, for your viewing pleasure, is the ungodly 210ZX. It looks like something out of Mad Maxx. Look at those bulging shoulders. Surely, less aerodynamic than the stock B210. Probably heavier, because I am sure the old fenders and unibody parts are still present under the faux muscular fiberglass applique “aero” kit. For me, it is UGLY and embarrassing.
Now, the Datsun 510, that was a good car; kind of a poor man’s BMW 2002.
October 7, 2017
The Claim Interpretation Standard is Not - Least Unreasonable Interpretation that Supports an Obviousness Rejection In Hindsight.
The Examiner is to employ the broadest reasonable interpretation of claim terms, in light of the specification. It is not reasonable to broaden a term in hindsight, outside the scope of the term in the specification, with the goal of rejecting a claim.
It is not reasonable to expect the specification to state all the things key terms are not. The specification is a guide to what is reasonable to include.
See the discussed Smith case at:
One way to fight the possibility of over-broad interpretations is to include a definition of key terms in the specification. I usually defining all my key claim terms. However, you have to be aware of the risk that definitions can be it can be considered admissions of, e.g., narrower scope of protection in some contexts. Optionally, has anyone tried having a definition, then also including alternate broader descriptions of a key term elsewhere in the Detailed Description?
This case might be useful to quote when an Examiner insists that you cannot import limitations from the specification. This case confirms that the specification, e.g., taken as a whole can limit the scope of term interpretation during prosecution.
Sheesh. I argue with an Examiner insisting that ANY chamber is an assay system that comprises a detection chamber. This, where detection chambers are well known in the art and repeatedly illustrated in the text and figures of the specification. I am sad that the system motivates Examiners to unreasonably broad interpretations, and ridiculous rejections still give Examiners “counts” for their quarterly quota.
Sorry. Grouchy today.
Sorry. Grouchy today.
October 6, 2017
Expression of Eye Color is Not So Simple
My daughters are mixed race. I have blue/green eyes. Maternal eyes are dark brown. Daughters eyes are light brown. So much for simple dominant/recessive control.
And, like mentioned in the article, both my parents have blue eyes, but my eyes are more green.
October 5, 2017
What Food Looked Like Before Human Modification
Kind of a fun slide show of fruits and vegetables before and after human selective activity. We grew only the “best”.
I assume someone is collecting seed banks of the original parental varieties and cousins. Heck, forget the seed bank. Let’s sequence them all and store them in a data bank.
October 4, 2017
New Motor Under Pressure to be Efficient
High compression gasoline engines have problems with ignition timing. Under ideal conditions they can be timed without a spark, or even a timed injection. This engine can fall back on spark timing in non-ideal conditions, e.g., cold starts.
As I recall, greater efficiency in a heat engine can be obtained with higher compression and greater differential between the intake and exhaust temperatures. Seems the Gas Compression-Ignition Engine manages to provide the higher compression. The article also makes much of the lower operating temperatures, e.g., provided by enhanced retention of previously burned gases (exhaust). This should reduce efficiency somewhat and also reduce power (due to effectively reducing air/fuel charge). Apparently these problems are more than made up for by the higher compression.
No comments are made concerning nitrogen oxides (NOx), a major nuisance in diesel engines. Maybe the engine has a smaller carbon burden, but a higher NOx burden. Maybe the exhaust gas retension reduces the NOx. NOx is a major contributor to SMOG (I remember the old days of Brown skies when I lived in the LA basin).
These engines could have a lower carbon footprint than an electric car run on electricity from a coal (natural gas?) power station, but not from a solar power station. Also, the power to weight ratio may not be the best.
October 2, 2017
Ironic Phages Attack Bacteria with CRISPR
It has gotten to the point that we need double and triple attacks to overpower pathogens, which have resistance to our old tricks. Innate and activate immunity are failing more often, especially with compromised patients. Throw in some antibiotics, but there is often resistance, e.g., present on a plasmid carried by the pathogen. What now? How about a phage against the pathogen, but the bacteria has a CRISPR to stop the phage. Help, help!
OK, turn the bacteria’s CRISPR back against it. Ironically load CRISPR into a phage capsid and attack a bacterial sequence with a double strand break. Also load a Gam sequence to block repair.
You need to get the CRISPR system within bacteria. If you have to chemically transform plasmids into the pathogen bacteria, you might as well just bleach them. There might be something to “phagemids” that use phage capsids to (specifically) inject CRISPR system encoding plasmids. Still, the technology seems limited to topical (wound, respiratory, GI) administration.
See more technically described concepts in a patent application:o:
September 26, 2017
Another Take on Cultured Meat – From Stem Cells?
I wouldn’t know (brought up poor and somewhat hungry in Montana, eating wild meat mostly) but I suspect most vegetarians don’t eat meat because they don’t like to kill animals. Believe me, hunting did not make me happy. There are also religious reasons, and the heavy burden it puts on the environment. Maybe some just don’t like the texture or taste of meat.
I have always thought it curious that there may be a big market for fake meat to feed vegetarians. By now, we are all already familiar with the fake hamburger that bleeds red (beet) juice when you bite into it. Would most vegetarians like that? Most vegetarians I know used to like meat, but “became” vegetarians.
The “sophisticated production processes of surimi” are used to solve some problems befalling makers of fake meat. I think the processes are not actually so sophisticated. My brother used to work a giant factory ship off Dutch Harbor in Alaska. He ran a surimi machine right in the ship that pureed the caught white fish and added desired ingredients to make it taste like crab, shrimp, or lobster. The white fish had little flavor of its own. The puree was then cooked and frozen. The process was simple, though the flavor formulations can be quite complex trade secrets.
I think this is all important research. Quality proteins are necessary to good child development. However they are too expensive and burn up too many resources in their procurement. I eat way too much red meat, but can enjoy a GOOD veg burger, hummus, or even surimi.
September 18, 2017
Bacteria Protecting Tumors From Anti-Cancer Drug
This is strange and raises a lot of questions.
Where do the Mycobacteria come from and how do they get to the tumor? The article suggests they may “migrate” from the duodenum. Mycoplasma do not have, e.g., flagella, but some do have a mysterious “gliding” motility.
What is the selective advantage for the bacteria in neutralizing the anticancer drug? They don’t appear to be eating the drug for dinner. Are they symbionts trading protection for a preferred habitat? Are the bacteria enriched at the tumor site or generally dispersed throughout the patient’s body? In any case, the bacteria seem to give the tumor an advantage.
How common is this phenomena?
September 12, 2017
Front Wheel Drive “Drift Mode”?
I have no idea how to race or skid a front wheel drive (FWD) car. I was brought up with Montana winters and enjoyed the way rear wheels slid around in the snow.
So, it seems I have seen front wheel drive cars in movies with their rear wheels sliding to the outside of corners in a serious over steer. Is this special effects; some parking brake move?
The article discusses a new Audi R8 that can be cool drifting on RWD.
September 11, 2017
Stratified Charge Making a Comeback
Seems to me that Honda came out with a Proco stratified charge engine about 35 years ago. It made a ruckus, then faded away. I suppose many problems that existed then have been solved with better computing power, better algorithms, better materials, and he ability to modify the charge and timing for various conditions.
Mazda has this one now, and I guess Ford is a player. Too bad the proco “holy grail” may have come after internal combustion is already on the wane for automobiles. Maybe in a hybrid.
September 8, 2017
Imaging Endoscope Probe Location Through Tissue with Only First Arriving (Unscattered) Photons
Visualization of endoscopy probe is accomplished by detecting 785 nm laser light pulse through thick patient tissues. This, against the background of ambient light of a clinical background.
An extremely sensitive single-photon avalanche detector (SPAD) array not only selectively detects laser photons, but is able to distinguish between photons that arrive relatively directly (sooner, with less scattering in the tissue) and photons that are scattered more and arrive late. The more direct photons can provide an image with high resolution, identifying the location of the endoscopy probe in real time, in ambient light. What an amazing detector.
August 29, 2017
Organic 1-a-Day Vitamins for All Vegetarians! How Depressing.
Got to love this article because the writer is not a journalism major with a political bone (hmm, apple) to pick. It is great how she looked for possible modes of action, yet left open considerations of sample size and the possibility of “reverse causation”. Ay, a writer that knows correlation is not necessarily causation!
Vegans I know, eat huge amounts of food. Try to go on a 5-day camping trip with one. Anyway, it was interesting that they on the average consume more pesticides; unless they want to pay a premium for “organic”.
August 28, 2017
Will Constitutional Policy Rule Over Congressional Intent in Loss of Rights to File a Patent?
The rule has been that if you publish or offer your invention for sale, you have a 12-month grace period in which to file a patent in the U.S. (and may have lost right to file in most foreign countries).
The law (35CFR§102(b)) was rewritten a few years back in the America Invents Act (which also changed the U.S. from a first-to-invent to a first-to-file country). The new section 102(b) included the phrase that the invention cannot be published or sold “or otherwise available to the public”. This new phrase has been interpreted by the Patent Office to mean that a private sale or private disclosure does not start the 12-month grace period for filing a patent.
However, I strongly suspect the federal courts will consider a private sale (with the invention identified in contract terms) to be an offer to sell, initiating the grace period. This is because the Constitution identifies the policy reason for patents as promoting science. Patents give a period of exclusivity (20 years) in exchange for disclosing new and non-obvious inventions. I believe it goes against this policy to allow delay of disclosure, while privately reaping the benefits.
When considering publication or sale (even in private) also consider that the rules in other countries may consider this a disqualifying disclosure, with no grace period.
Also keep in mind that even if the current environment may appear to allow private sales and disclosures, the rules may change with retroactive enforcement, e.g., invalidating issued patents.
August 23, 2017
Can I Patent My Cake Recipe (Formulation)?
Several times I have has clients ask about patenting a food recipe. Talk about an ancient art. Many recipes can be new, but try to argue non-obviousness of using each ingredient for the same use as has long been known. Hmmm … maybe TexMex is old, but how about Serbo-Inuit?
Protection of recipes (e.g., Coke) basically comes down to well administered trade secret protection, as discussed in the article.
It is a lot easier to patent a pharmaceutical formulation, e.g., because there are more likely surprise activities and interactions between ingredients. Or, the active ingredient is newly man-made.
August 22, 2017
If It is Natural, It Must Be Good. If a Little is Good, a Lot is Better.
A little good press, or suggested theoretical benefit, can be taken too far.
Turmeric has many beneficial aspects. It contains a dozen bioactive molecules that can act as reducing agents, inhibit bacterial growth, inhibit cancer cells, color things yellow, inhibit liver enzymes that metabolize pharmaceuticals such as anti-cancer drugs, strongly initiate the coagulation cascade in blood …
Turmeric causes the liver to work pretty hard processing all the complex molecules, such as curcumin, terpenes, and vitamins. I have a friend who used to put 3 tablespoons of turmeric into his morning protein shake, until he ended up in the hospital with acute hepatitis.
I use turmeric a lot. I use it to stop bleeding on days I am doing mechanic work, to make soups store longer in the refrigerator, to promote healing of scrapes, and to color my curries. However, I assume injecting turmeric would immediately cause a serious blood clotting episode that can kill you.
Activated charcoal may be useful in adsorbing toxic organic compounds in water filters. A gastric flush with an activated carbon slurry can help remove overdosed drugs, hydrocarbons, or pesticides from a patient’s stomach in the emergency room. I suppose charcoal could remove some cholesterol (and vitamins) from the digestive tract, not that diet cholesterol is important to blood cholesterol levels. By the way, please do not inhale activated carbon dust to cleanse your lungs.
Peroxide is a rocket fuel that can burn you. Peroxide is not oxygen, but a source of extremely chemically active oxygen radicals. Everyone is raving about the antioxidant benefits of chocolate and blueberries keeping them younger. Meanwhile, are they also freshen their systems with oxidizers (which are actually the main source of ageing). Seems bleach would be cheaper if you wanted to oxidize yourself.
August 21, 2017
Infamous One-Click Purchasing “Technology” Soon in Public Domain
Now, we can get stuff from all stores another 3 seconds sooner than getting in our cars. That’s if I could invent a way to make the postal carrier 3 seconds faster.
Is this the patent that led to the patent system fall from grace with the public? Maybe this and the patent on ways to swing on a swing.
One-click was apparently new in 1997. Obvious? It was run through a full reexamination at the Patent Office in Amazon’s favor. However, given the problem of too many steps in electronic check out through the internet, do you suppose one of skill in the art at the time could have arrived at the one-click solution, e.g., without undue experimentation? I suppose the patent survived because it is not obvious to solve a problem never mentioned in the prior art.
See issued patent 5,960,411, including minor modifications to claims from Reexamination:
I have only used one click a couple of times. I still like to double check all information before sending my money down that optic fiber cable.
August 17, 2017
Did You Wash Your Hands Dr. Billy? Yes Mommy (tee hee).
When I worked as a process engineer, developing and up-scaling pharma manufacturing processes, I thought all the hand washing (and alkaline solutions) were ripping up my hands. But, this was not as bad as when I was a staff Medical Technologist at Stanford Medical Center. I washed my hands so often all my cuticles and finger tips were cracked.
I kind of get how the 3D photo data tracks “pedestrians” (doctors and hospital staph) as they go about their rounds in a hospital wing. It is not clear to me how the system initially identifies each pedestrian.
I have to mention that this is intrusive, but that is what you get in the medical industry. Health and safety trump other factors everywhere in government and medicine.
See more specifics on the technology at:
Think of how the knowing pedestrians could play tricks on the algorithms. There must be ways to trade pedestrian identities with your friends (just like when there was a substitute teacher in 4th grade) or hang out by the wash area, even when not actually washing (gold star hand washer).
August 15, 2017
Joints – Wear and Tear vs “Use It or Lose it”
This is old news. The first thing I learned in my biomedical courses in collage was the old adage – Use It or Lose It.
Connective tissue is continuously repaired and replaced. Much of the information required for reconstruction comes as stress from use. These stresses help orientate the cells and fibers laid down in maintenance.
August 14, 2017
Surprise! Surprises are Not Obvious. Accidental Esterification Renders Drug Stable and Patentable
The inventors (Millennium Pharmaceuticals) were lyophilizing an active peptide drug in the presence of mannitol and were quite surprised to find the product far more stable than expected. They analyzed the material and found a stable active ester prodrug had formed in the lyophilization process.
Millennium filed for a patent for the composition. The Patent Office and District Court rejected essentially on the basis of alleged inherent existence of the product; giving no credit for invention, since it was found accidently. The ester product of lyophilizing an artificial peptide with mannitol was said to inherently obvious.
I believe there is no such thing as an inherently obvious surprise. If the ester had been previously made, without the manufacturer ever knowing, the ester would not be considered new (novel under 35§102) i.e., it would be inherently anticipated. The drug would not be new, because it unknowingly previously existed. However, this was never alleged in the rejections because the Patent Office could not find an example in the prior art of anyone lyophilizing the drug in the presence of mannitol. So, the Patent Office fell back on the inappropriate, and illogical theory of inherent obvious (under 35§103).
Thank goodness the Federal Circuit Court correctly reversed the decision of the lower District Court (and, I assume the Appeal Board and Patent Examiner) by confirming the surprise result was not obvious. No one at the Patent Office gets in trouble for rejecting claims, but many are afraid to allow claims that they feel are obvious in hindsight. $200k+ later, Millennium found a Court that was not stupid (biased? afraid?) and willing to follow the law and precedent.
How crazy is the Patent Office? If you expected the result, it was obvious. If you were surprised by the result, it was inherently obvious. Sheesh.
August 8, 2017
Taxi! – Follow That Bird.
My first emotion about all this talk of flying taxies is the unfairness that I went through all the training to get my pilot’s license and unskilled Johnny-come-latelys want to swoop blindly into MY airspace!
My next thought is annoyance with the Computers that are taking away all the fun. What fun is there is being chauffeured about, and how long ‘til manual flight is pushed aside? The biggest remaining problem for driverless cars is … Drivers. For example, when a driverless car comes up to a 4-way stop sign, how does it deal with the stupid humans that do not know whose turn it is to go? The only solution is to assume the computer is always right and eventually eliminate the human drivers. The same thing is going to happen in the air.
And, the air is going to get crowded. Even near cities, we human pilots can still roam freely VFR outside tower airspace. With the crowded computer controlled airspace, we might all be mandated to Chinese style controlled flight plans, flown by computers.
I guess my main problem is that I feel the licensed pilots are the elite rulers of the sky and it is annoying to realize that we may [soon] be overrun by a bunch of pushy know-nothings. Obama [liked him] called us unlikable elitist “fat cats”. I suppose we General Aviation royalty will eventually be sacrificed for the greater good of the passive flying proletariat.
August 4, 2017
B52 for 30 More Years – New TurboFan Engines?
See the interesting animation video Boeing produced, highlighting the benefits they see in updating the B52 engines over continuing to rebuild the old TF33 jet engines.
August 3, 2017
The Dogma Requiring “Full Course” Antibiotic Administration May Be Breaking
I always wondered about the dogma that one must complete the prescribed course of antibiotics. This rule was the same no matter the patient, antibiotic, or pathogen.
I guess the theory goes that you have to kill every last one of the pathogen, including any subset that is a little more resistant, so a remaining more resistant population does not rise up in a continued infection. However, this seems a little simplistic.
Wouldn’t that new population be about as easy to inhibit with the same antibiotic as it was near the end of the course? How many more beneficial bacteria would have been destroyed by completion of the course? Isn’t the continued course continuing to raise resistance in the pathogen and other species of bacteria in the patient?
Doesn’t an excessively long course release more of the antibiotic into the general environment (and cost more)?
I still see the main problem with antibiotic dosing to be the amazing failure to rapidly and inexpensively identify what antibiotic is most potent against particular pathogens. It is not the course, but the choice of antibiotic that seems most important. When I was working at Stanford Med. Cntr. 30 years ago, we were still doing the Kirby-Bauer antibiotic disk diffusion culture and sensitivities assay. Expensive and slow, and rarely ordered. We already had computers doing cell blood counts then. With all the next gen DNA sequencing breakthroughs, why do we not have a rapid and inexpensive antibiotic sensitivity assay so we can get the right antibiotic and dose to patients?
August 2, 2017
Identifying Edible Mushrooms is Not as Simple as "AI"
The book I use when TRYING to identify mushrooms is Mushrooms Demystified; more than 600 pages thick.
Hmmm. A yummy straw mushroom and Aminata phphalloides (death cap) look pretty much the same, like little eggs, just before they come out of the ground. Identifying mushrooms requires seeing the top, breaking the stock, determining the color of the spores, seeing how the gills branch or attach to the stock. There is more information in the size, smell, and where it is found (e.g., under an oak tree).
There is simply not enough information in a single photo (or several photos) to identify a mushroom confidently.
My wife and I have taught ourselves to know the few mushrooms that are most toxic. Most mushrooms in California will not easily kill you, but many will give you quite a stomach ache. For eating, we stick to the easily identified ones with no similar toxic mushroom – e.g., shaggy mane, shaggy parasol, oyster, many puffballs, many boletes (Satan’s bolete will make you sick, but is identifiable by the beautifully different bright red color).
Growing up in Montana, it was mostly tourists that got killed by grizzly bears. Here in California, sorry to say, it seems recent immigrants are more likely to make the mistake of eating a death cap.
August 1, 2017
Man Throws Ball at (and Hits?) Landing Jet
The photos make it clear that the ball could easily have been sucked into an engine.
July 30, 2017
Giant Time Release Stomach Blob
I have seen a lot of time release formulas. It does not seem crazy to have this pill that swells up in the stomach and slowly degrades to release a drug, e.g., over a week.
With this blob in your stomach, you might even lose weight from loss of appetite.
The mixed polymer lob of alginate and polyacrylamide is unnatural enough not to be quickly dissolved in gastric juices.
One odd thing. I worked in the lab sooo long ago that I used to pour my own polyacrylamide gels. We had to wear gloves and avoid contact with the gels because they were considered toxic. The acrylamide monomer is a neurotoxin. I assume the blob makers go out of their way to leach out all non-polymerized acrylamide from the gel before administering the pill.
Hmmm. The pill comes with an optional “antidote” that quickly breaks down the gel – hopefully not over-dosing the patient on the flood of released drug.
Must I always see problems? The invention actually seems to have its place for administration of compatible oral drugs.
July 26, 2017
BioSimiliar Notice Clarified by Supreme Court
A biosimilar manufacturer of a biologic pharmaceutical can rely in the original owner clinical studies if they can show their product is essentially equivalent physically. However, I believe the rule is that the biosimilar applicant should give notice to the original patent owner at least 180 days before the generic applicant markets the biosimilar (of course in possession of an FDA license for the biosimilar at the time of marketing).
The article gives useful alternative strategies for a biosimilar manufacturer for giving notice to an original patent holder.
July 24, 2017
What? CRISPR is Not Perfect?
No nucleic acid duplication or repair mechanisms are perfect.
In the CRISPR/Cas9 gene drive schemes to wipe out undesirable organisms, errors in repair or insertion to the specific CRISPR target cut can provide a “mutation” rendering the cell immune to the killer gene drive mechanism. That is, the highly specific CRPSR target is changed and no longer a target of the gene drive, so the undesirable organism survives to reproduce.
As has been the case from the start, the imperfection of gene replication provides more long term benefit (e.g., the basis of population evolution in response to changing environments) than a curse (to debilitated individuals).
After the initial hype, we must realize that although CRISPR/Cas9 is a giant step forward in safer engineering of living cells, there are still risks in driving genes and genetic modification of organisms.
July 20, 2017
Brazilian KC390 Competing with C-130 to Lift Military Cargo
Key factor for C-130: It can take off in half the distance as the KC390. Sure a 737 or 747 can beat a C-130 for speed and lift, but they are not military cargo planes because they require about the same distance to take off as the KC390.
The C-130 can land and take off in 4 times as many fields (developed and undeveloped) as the KC390.
July 19, 2017
Charge Electric Car in “Seconds”
How can you get that much energy through a wire into the
car battery in only seconds? That's a lot of kiloamps.
That's a lot of kiloamps.
July 10, 2017
Overturn a PTAB Decision in Federal Court and YOU Pay the PTAB Legal Bills[!?]
This is worse than the rule that requires Appellants to pay $1000 to “forward” an Appeal after receiving the Examiner’s Answer. The Examiner can have a lame Answer, but you have to pay $1000 to have it reviewed.
Now, I see that if the PTAB Decision is bad, they don’t have to worry because they have no negative impact if the Appellant takes them to Court. No matter what, the Appellant has to pay the PTAB Court and Attorney costs. Great deal. I wonder how careful they would be with the money.
Let’s see. Pay $1000 to send an Appeal to a stupid rejection to the PTAB, then pay BOTH the PTAB and your legal fees, even if the Fed Court finds in your favor!
Hmmm. Now, let’s all guess who gets to calculate the PTAB legal bill.
Sheesh. GOVERNMENT, it is superior and has preferred standards over we the [little] people.
July 7, 2017
Rube Goldberg Drug Dosing Pill
I don’t want to appear mean. It does appear a concept like this could be made to work. But … so complicated. There are a lot of materials and engineering problems that I assume have not yet been worked out; interactions that may be inconsistent, complexities that increase cost and can lead to variable dosing.
A [large?] capsule is swallowed. At a certain pH (out of stomach acid) bubbles are formed to force a bellows out of a housing, then to expand laterally, thrusting depot formulated pharmaceutical needles into intestinal walls. The main body of the capsule dissolves, along with the bellows. The needles of sustained release active agent remain in the intestinal wall, slowly dissolving to release the pharmaceutical into the blood. Lots of pushing, dissolving, and releasing; with timing dependent on the mechanics and liquid environment of the intestine.
This is quite a variety of dissolving materials having a variety of mechanical functions. Gasses, pistons, bellows, needles; interacting with contorted intestinal spaces. I am not sure why so many of the parts have to dissolve at all; as long as the bellows collapses and somehow leaves the needles.
A big limitation seems to be that the bioactive agent (peptide) being released must be only a small proportion of the needle mass, and the needles can’t be too big. I can’t see this working for insulin. This may be the best way to deliver for only a few specialized indications (vaccines?). Seems easier, more consistent, and cheaper to just inject the dose subdermal.
What are the advantages of this over the new microneedle skin patch flu vaccination?
July 6, 2017
Is Torque Steer the Most Annoying Thing About Front Wheel Drive Cars?
In my opinion, the “most annoying” thing about front wheel drive is not torque steer. My main complaints are wider turning radius, bad traction on accelerated turns (front having to both turn and increase speed), and unweighting of the drive wheels on a fast start.
But, this article is about torque steer. I never understood torque steer. I thought it had something to do with acceleration of a gyroscope. Well, apparently is mostly has to do with a combination of unequal drive shaft lengths and wheel geometry. The main culprit seems to be the fact that traverse mounted engines, with the differential on one side. This requires a short drive shaft on one side and a long shaft to the other wheel. Depending on the design, the longer shaft can twist more (like a torsion bar) before the force gets to the wheel, and/or the different linkage angles affecting the wheel angle or tire patch (now, I must just be making things up).
Apparently the Honda of the article uses a limited slip differential and a design placing the differential closer to the center line for equal length drive shafts.
[Diverging.] Talk about torque steer. I fly small single engine airplanes, and their direction of flight is constantly influenced by the engine, and propeller angle. In particular, there is a “p-factor” on climb outs wherein the aircraft is angled up and the propeller is tilted back traveling through the air stream. The prop turns clockwise, as seen from the pilot seat. With the nose up on climb out, a propeller has a higher angle of attack into the air stream on the right side, generating more thrust. On the way back up on the left side, the propeller blade is tilted back relative to the air stream with a smaller angle of attack, providing less thrust. More thrust on the right pushes the plane to the left. So, single engine propeller pilots eventually develop a reflex to push right rudder on climb outs to keep the plane from turning left. This phenomena is even more pronounced with helicopters, where the propellers are horizontal and moving at dramatically different speeds left and right through the air stream when the helicopter is moving forward.
Where was I? Oh yeah. The other thing I don’t like about front wheel drive is they are less fun in the snow. I grew up in Montana and had rear wheel drive cars. In the winter I would steer with my rear wheels. With my best studded snow tires on the front of my Ford Econoline hippie van, I could turn a corner with a slight turn of the steering wheel followed by just a little extra gas. The rear end of the van would swing (slide) around until I let off the gas a little. Rear wheel steering. It was fun being a teenage driver in winter Montana. This is the over-steer used by race car drivers to take corners at higher speeds, and one reason race cars are almost never front wheel drive (which tend to experience under-steer).
Sheesh, I guess I am not a big fan of front wheel drive cars.
July 5, 2017
Nanotubes to Cure Spinal Injuries - NOT
Seeing the article title, my first thought was that the nanotubes might be suggested as an unlikely conductor between neurons across nerve damage. Then, maybe as a template directing axon growth.
However, the article seems to merely suggest that a mat of nanotubes can be a growth substrate for neurons in culture. Hmmm. Maybe neural stem cells could be implanted in a nanotube lined conduit across a cut nerve. The nanotubes seem not to be antigenic. Yet I believe they are not very biodegradable. This could be good, or bad.
Not the “best hope for repairing injured spines”. Science fluff article.
June 27, 2017
EpiPen Competition – Is a Cheaper Injector By Another Name As Perscribable?
I had previously blogged that EpiPens are old technology, off patent, and that the high price in the market would inspire competitors …
However, do not underestimate the power of a trademark. Doctors will continue to prescribe EpiPen TM brand because they are familiar with it.
June 26, 2017
All Genes are Some Body – Everything Matters
Ok, ya got ta love the old school Sanger gel the article. Brings back memories. (Sheesh. I actually even did a Maxim-Gilbert.)
All the world is shaped by the mass action of micro-influencers. So, to with genetics. Frustrating that most phenotypes are complex. It makes finding effective drugs more difficult.
I remember my first collage genetics class repeated the old rule that eye color is controlled by dominant and recessive genes. Hmmm. Well, my wife and eye are mixed race, and her dark brown eyes did not totally beat out my green eyes. Our daughter has light brown eyes.
The math seems a little strange in the article. I guess there are about 30,000 (protein encoding) genes in humans, and about half are expressed in any given cell type. I suspect that the de minimus influencers are actually not important, even in their (washed out counter-influencing) mass action. I bet the greater background influencers are non-coding controllers of expression and epigenetic factors.
Then, there is sickle cell …
June 14, 2017
Cool RF Ablation for Pain Relief
Apparently, the hot RFA is more damaging to surrounding tissues so cannot target nerves far from the electrodes. I see similar techniques have been used for back pain. I was unable to readily determine the mechanics of the cooling (is it generalized or cooled at the electrodes themselves?).
The benefits of cool radio frequency ablation (CRFA) last 6 to 12 months. Amazing how nerves grow back so well when you do not want them to.
June 13, 2017
Seems Porsche Diesels have Fancier SMOG Cheat Algorithms
There they go again. It is hard to keep efficiency up with NOx down in a diesel.
Funny the cars tried to trick the smog test by using the momentum detectors (probably the same ones used for automated antiskid yaw control) to identify when the car is on the road, instead of on a dynamometer in a garage.
I wonder why they expected not to get caught.
June 1, 2017
Secondary Considerations are Inconsideration at the PTO, But Maybe Tertiary Now at PTAB
The secondary considerations were supposed to have weight after the Graham v. John Deere decision of 1966, and they were memorialized in the MPEP.
In my whole career, I have never seen an Examiner give secondary considerations any weight during patent prosecution. The Patent Appeal Board (PTAB) almost never gives them any weight. However, there have been a couple of Federal Circuit Court decisions lately respecting secondary considerations, which may explain why they seem to have carried the day in this example at the PTAB.
May 31, 2017
Yes, You do Own the Things You Buy – Patent Exhaustion and SCOTUS
This is great news. The Supreme Court you can sell your used ink cartridges and they can be refilled and resold without infringing patents on the cartridge.
Not being able to refill your printer ink cartridge is bad enough, but I am glad the slippery slope now has sand on it. Imagine if Ford could use the 1000 patents on a car to tell you how you could use or sell the car you just bought? What if you would infringe on a water heater patent by selling hour house.
What was the patent claim allegedly infringed in this case anyway? A claim against the new and non-obvious method of refilling a cartridge? Weird. I glanced through the case and they don’t seem to bring up the subject of What Claim is Allegedly INFRINGED By the Act of Refilling a Cartridge. Shouldn’t that have been the first step in analysis of this case?
Lexmark should have lost a lot of business for the practice of monopolizing their cartridges, used or not, patented or not. One of my old HP printers used to refuse to continue using a perfectly good HP cartridge (never refilled) just because I had removed it and replaced it (like I had put in a refilled cartridge). Sheesh. I was so mad, I never bought an HP printer again. Market forces.
Yes market forces. Lexmark sells printers at fairly low prices. I hear they lost money on the printer but made it up on consumables (cartridges). (Sorry to diverge, but this reminds me of airline business practices lately – cheap ticket but make up on inflated options on food, space, carry on fees?) Now, we just might have to pay for the printer; and get the cartridges cheaper. Good enough.
This is exhausting.
May 30, 2017
FDA Licenses Antibody to Attack Cancer Antigen Instead of Against a Particular “Organ” Cancer
There are a lot of “normal” antigens that are different between cells in different tissues. And the blood flow, connective tissue, immune surveillance, and such are different in different tissues and organs. However, when it comes to fighting cancer it is not the different organs, so much as the difference between the cancer and normal tissue that is important.
For a looong time, the fact the cancer cells were growing Faster than Most normal cells was the main difference exploited by cancer drugs. The drugs generally did not distinguish organ types or cancer types well. Lately, there have been more therapeutics that can distinguish between particular cancers and leave most normal tissue alone. These have been licensed with indications directed to organs, like lung cancer and skin cancers.
The antibodies of this article are taking another route that I hope will be successful. There is a broad array of cancer cell surface antigens that could be attacked with antibodies (e.g., carrying toxins or binding killer cells to the target). These antigen targets can be found across a variety of cancers in different organs. It is a new phase that the FDA is classifying cancer antigens as targets and not just the old system of licensing drugs against particular cancer indications.
Apparently, the antibody here binds to the programmed death-ligand 1 (PD-L1) also known as cluster of differentiation 274 (CD274) surface antigen. This antibody is useful in about 4% of advanced cancers. Down the line, we hope a library of antibodies can be identified to attack most cancers. This, along with quicker diagnostic to identify cancers earlier could hopefully cut cancer deaths in half.
May 25, 2017
What is the Reason for Those Plastic Engine Covers in Modern Cars?
No one seems to really know in this article. Why do most modern cars have a big plastic cover over the engine when you open the hood.
When I was a kid in Montana, most of the guys were into cars. We could drive at 14. Bought old cars and mostly kept them running ourselves. We would pop the hood and lean over the fenders talking about carburetors, timing, and such. Yesterday, I saw a couple guys talking and they popped the hood on a new muscle car, and what the heck were they looking at. Wow! What new technology! Really cool engine cover.
Noise reduction. I vote for appearances and covering the wires and technology young men do not understand now days, anyway.
May 22, 2017
Antibiotics are Soo Cheap That They are Not Available (?).
A lot of the problem with trying to provide quality antibiotics at a low cost is … trying to provide quality antibiotics at a low cost. So, we allow a low quality provider (usually China) to corner the market. And, as would be expected, they try to cut corners to avoid losing money. And, with sources limited, the manufacturers can, at least in the short term, reduce production. Thus, low quality at a low price, with low availability.
When I used to work as a Process Engineer in pharma, it was an expensive (but necessary) nuisance to generate standard operating procedures (SOP documents) and to follow them with stringent discipline. One small error and a million dollar batch was down the drain. I can’t see certain less restrained (ethical?) businesses doing this. They could rationalize that the error did not compromise the product (and they would Usually be right). However, in light of this, it is strongly advisable that those receiving pharmaceutical products or intermediates from the developing world do their own quality control evaluation before releasing to the public.
The antibiotics are off patent. Now they are manufactured and subsidized in developing countries capture most of the market, and these drugs can legally enter other countries. But the (unintentional) side effect is that the market is unattractive for unsubsidized manufacturers everywhere.
Government(s) are causing part of the problem. Now, sorry to say, any solution requires their participation, e.g., helping or not hurting motivation for skilled manufacturers to produce required antibiotics. (Typically, this involves the U.S. and West subsidizing the world directly and indirectly with research and price supports; you’re welcome.) This scenario is somewhat similar to the situations in the U.S. where personal injury lawsuits (the Judicial branch of government) made it too expensive to make vaccines or small airplanes. When the liabilities were lifted (and vaccine profits guaranteed) by Congressional action, vaccines and airplanes began to be manufactured again.
Not mentioned in the article is that one partial solution would be if someone could develop a quick, accurate, and inexpensive technique to IDENTIFY SENSITIVITIES of pathogens to an array of antibiotics. That is, we need to stop blindly administering antibiotics to patients on a hunch. If we identify the most appropriate antibiotic for the particular pathogen up front, the patient will get better sooner (e.g., not die), and we will not be adding selective pressure for resistant pathogens to become super resistant. Proper targeting from our current array of available antibiotics could greatly reduce waste of current antibiotics and reduce our need for NEW antibiotics.
May 11, 2017
Ultra-Sonic Brain Permeation for Alzheimer’s Patients
I wonder how practical this is. I suspect the enhanced permeability is short lived, over a small area, while most drugs would be highly dispersed outside the blood/brain barrier. Really bad pharmacokinetics. But, better than nothing.
Non-invasive. No side effects. I guess there is no inflammation; although, it seems a little inflammation might help enhance the permeability and increase diffusion times.
I had thought the sonic waves could loosen up the endothelial cell junctions without help. But, the method includes injection of micro air bubbles that physically vibrate more than the local water. Seems this would not work well either. Wouldn’t the gas in the bubbles dissolve in the patient’s blood rapidly, given the very high surface to volume ratio? There must be something I am missing.
Ok. I don’t know anything about this.
May 10, 2017
Eating Excessive Salt Reduces Water Consumption - Crazy
How could something this import and well-studied not have been known previously?
If I eat a lot of salt, I am soon quite thirsty, and later urinate more than usual. However, this study suggests that on a regular diet of high salt (6, 9, 12 g/day – the NIH suggests a maximum of 2 g/day) water consumption actually goes down and hunger goes up. All bad. It is not clear from the article, but I suspect this has not been previously discovered because it takes a while for the low water consumption to set in after a high salt diet begins (?).
High salt increases blood pressure for most people. The study suggests high salt eventually increases glucocorticoid levels, leading to immune suppression and muscle breakdown. The breakdown of proteins generates more urea which apparently causes more water to be retained by the kidneys. So … consumption of excessive salt eventually leads to less consumption of water.
Excess salt may result in less use of water by astronauts (and maybe reduced inflammation), but this benefit would seem to be overwhelmed by the other effects of immune suppression, bone loss, muscle loss, and increased hunger. I think astronauts should eat less salt, even if this means drinking more water; it all gets recycled anyway in the space ship.
Again, why is this information new?
May 8, 2017
Phage Should be the Rage in This Antibiotic-Resistant Age
Phages can be a good back-up treatment against bacteria resistant to antibiotics. There are some problems, though.
A particular phage (or family of antigenically similar phages) can only be used once before the patient’s immune system inactivates it with an antibody response. I know E. coli can be attacked by a wide array of totally different phages. Hopefully, we can develop libraries of phages against any particular antibiotic resistant pathogen species (many of the Enterobacteriaceae), so we can switch phages like we switch antibiotics.
The FDA requires that the compassionate use phage dose be purified. Though the product is self-propagating, the first dose should be a strong one and free of endotoxin. I used to be a process engineer and know that one size does not fit all in purification, AND documentation and validation of processes is time consuming and expensive. Hopefully, most phages can be purified in large batches and stably stored until needed.
Patenting. Natural phages cannot be patented. In many countries, methods of treatment cannot be patented. There is case law in the U.S. arguing that combinations of microorganisms, not likely to be natural, are probably not patentable. A method of preparing a phage batch, or unobvious formulations for storage of phage may be patentable. So … the difficulty in obtaining intellectual property rights to these therapies is probably making progress difficult.
The article does not mention passive immune therapy. I know of at least two companies that have developed monoclonal antibodies against Acinetobacter baumannii.
And, “phage” sounds scary. Maybe there would be better acceptance if they had a more friendly name … like, nano-nano friend.
May 6, 2017
This Big Mouth Frog Can Tell You if You are Pregnant, and More
How interesting can the African clawed toad (Xenopus) be? It has no teeth but is the only amphibian with claws to tear apart its prey. It is an invasive species that has wiped out many other amphibians across various continents.
Xenopus was used for decades as the standard confirmation of pregnancy in humans. A bit of a woman’s urine was injected into the frog (toad?). If there was human chorionic gonadotropin (hcg) in the urine, the frog would lay eggs in the next few days.
In molecular biology, the cytoplasm of the large eggs continue to be used for in vitro translation. The mRNA of interest is mixed with the Xenopus egg extract and the associated peptide is translated.
How much do we owe this toad (frog?)? I suppose we are about even, being as how we have spread them all over the world, including the southern U.S., South America, and Europe (the “cane toad” is the winner in Australia).
May 5, 2017
Inherency Rejections are Not Necessarily Difficult to Avoid
Yes, you are creative to use a structure having a previously unknown function. Certainly, this is not obvious. But, the creation may be anticipated, unless the claims employ the previously unknown function in a way not inherently (necessarily) practiced in the cited art.
I love section 102 rejections because they are so straight forward. Either the claimed invention is new or not. If the Examiner “deems” the claim inherent in prior art, all you have to do is use facts to describe a situation where, e.g., the identified structure in the prior art would not have the function.
As the article says, it is good to avoid the rejection, or strengthen arguments against an inherency rejection, by requiring the claimed structure to do something the structure in the prior art does not necessarily do.
The Examiner often follows up with an obviousness rejection in combination with another reference, but what can be Obvious about combining the new reference with the previously Unknown function of the first reference?
May 4, 2017
Angioplasty Catheter that Catches Embolisms Freed by Balloon
I always imagined that debris would float off during a balloon angioplasty.
I guess the device is too long for cardiac angioplasties? Should be good for carotid work, though.
Artery catheters have been around a long time. Still, new, improved, versions of balloons seem to pop up with regularity.
May 3, 2017
More and More Fed Circuit Cases Forcing PTAB and Examiners to USE FACTS
In my experience, it is common for Examiner to make cursory conclusory rejections and place burden on me to apply facts to law, e.g., showing the rejection combination is not obvious. For example, the combination changes the principle of operation in the primary reference and/or requires the limitation incorporated from the secondary reference to function differently; and there is no motive, e.g., because the combination solves no problem of record.
When I am right, I am right. But, that does not mean the Examiner is “persuaded”. So it goes to Appeal, and I usually win (unless the PTAB is wrong too;). And, when I win, I will be dog-goned if the Examiner doesn’t do another search to find cumulative art for new rejections in a new lame non-final Office Action (with more “counts” for the Examiner’s count quota).
Interesting here that it is noted that “examiners must examine an application for all conditions of patentability (and make corresponding rejections) at each office action and are expected to bring forward the best available references in a rejection. See 37 C.F.R. 1.104(a)(1). As a result, when an examiner is reversed, an examiner ‘should never regard such a reversal as a challenge to make a new search”. It would be nice if this were enforced - about half my Appeals would not be necessary because the Examiner would not get rewarded with bad behavior “counts” for answering an Appeal Brief with junk.
Geez. I did not know I was so sensitive about this. Very therapeutic to get this off my chest.
May 2, 2017
Speed Not Driven by 15% of the Fastest Drivers is Safest.
Artificially low speed limits cause a disrespect for authority. (For me, particularly because the police are usually the worst offenders of traffic laws.) And … low speed limits justify crazy slow (unsafe) driving by certain (pick your group) people.
I was raised in Montana, where there was no speed limit on the freeway during the day. I was a 15 year old coming home from work at 105 mph. I needed to “blow the carbon out”. Not crowded out there.
Coming next: Computers driving cars. Fast lane 95 mph, lane two 85 mph, truck lane 75 mph.
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