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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.
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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