I think that "method" patents don't get enough scrutiny by the public. If you read claim one, what they are preventing is: anyone identifying someone with diabetes and then putting that person on a calorie restricted diet.
It's not clear to me why the government should grant a monopoly on this technique, even from a theoretical standpoint.
Somewhere in my innocent heart flickers the hope that patenting fasting wouldn't be possible even in a parallel universe where it's not part of Islam, Hinduism, Jainism or Buddhism...
That seems very anti-competitive. So basically, if fasting is a free treatment for diabetes, you can't promote it without paying these guys a royalty? Boooooo
Telling a patient to fast is basically a clinical practice. Almost like checking blood pressure. No actual supplies needed, just behavioral counseling.
By the same logic, could I patent checking blood pressure?
> Does that mean people can't fast without violating the patent?
From the language, it would suggest that you'd have to administer this as a treatment for diabetes. And it's a very specific form of fasting, not fasting in general.
1. This link is to the as-filed application. The recited claims are not what ultimately issued. Linking to the application rather than the granted patent is dubious. https://www.google.com/patents/US9386790
2. A patent practitioner will utilize method claims in order to apply something known in the art, such as general fasting, in a new and novel manner. This does NOT cover plain-ole fasting. You can fast without violating this patent. What you cannot do without a license to the patent is perform the method in its entirety.
The independent claim recites:
1. A method of treating a symptom of diabetes, the method comprising:
identifying a subject exhibiting symptoms caused by pancreatic beta cell destruction,
the subject having a normal caloric intake; and
administering multiple cycles of a diet protocol to the subject wherein a fasting
mimicking diet is provided for a first time period and a re-feeding diet is provided
for a second time period, the fasting mimicking diet providing less than about
50% of the normal caloric intake of the subject with both protein restriction and
sugar restriction and the re-feeding diet providing 60-100 percent of the normal
caloric intake of the subject, depending on a need to lose weight wherein the first
time period is from 2 days to 6 days and the second time period is from 7 days to 85 days.
The take-aways form the claim language are:
A. This is a method of treating a symptom of diabetes. In order to infringe, you must be treating diabetes by performing the method.
B. You must actively identify a subject exhibiting symptoms caused by pancreatic beta cell destruction, and the subject must have a normal caloric intake. If you are an individual who is fasting to treat your diabetes, you don't infringe by performing this method. You did not identify a subject exhibiting symptoms caused by pancreatic beta cell destruction. You are merely fasting.
C. You must administer multiple cycles of this fasting and refeeding, within the exact caloric-intake ranges required by the claim, and within the exact time frame required by the claim.
TL;DR: It's toothless for all except treatment centers which diagnose and identify this "subject exhibiting symptoms caused by pancreatic beta cell destruction" which could potentially prescribe this very specific dietary regime to "treat a symptom of diabetes."
"Linking to the application rather than the granted patent is spreading misinformation and is click-bait"
This strikes me as unduly harsh for an honest mistake at worst. Updated information is always preferable, but I have a hard time seeing any bad intent in the original comment.
I appreciate your informative explanation. I think it's important that we have the facts when discussing this.
I will say that you've sort of missed what I think is the important part:
We as a society have decided that it's acceptable to legally bar medical practitioners from performing life saving treatment of sick individuals.
The only explanations I've heard for why that might not be crazy has unfortunately been simple and hand-wavey. Specifically I've heard that patents protect innovators, and the idea is that protecting innovators by intentionally granting them a limited monopoly on the use of their invention will create a society more likely to produce new innovations. The idea is that despite clear negatives, patents offer a net benefit to society.
The problem is I can easily imagine scenarios for either side of that argument, but I've never heard a comprehensive argument in favor of the current way of doing things. I also can't help but notice that patents often protect the establishment by granting the wealthy more monopoly power. Given that the legal system is in many ways captured by the wealthy establishment, I question whether the patent system continues to exist because it is truly beneficial to all or because it benefits the elite that also extert significant power over the legal system.
If the latter were true, then it could also be said that patents are another example of the establishment hurting the masses for their own gain. And in this case (again, as you pointed out the practical effect of this example may be small), the patent system is creating a risky legal situation for those who would try to provide medical care for sick members of our society.
As an anecdote, 3D printers were $30k until several major patents expired. Then small companies formed and in less than 10 years we created excellent 3D printers that cost $329 (I just bought one of those).
I can't help but wonder what the cumulative effect of artificial monopolies is on our society. Because it's invisible it's hard to calculate, but it's clear to me the effect is large.
I'm open to any insight into these matters. My plan is to promote the voluntary open sourcing of engineered works, but I'd sure love to stop supporting the patent system in the first place (I think).
I think you've identified the key issue: "What patent policy is in the best interests of society?" In granting monopoly rights to inventors, we incentivize innovation and society gets the benefit of new and useful inventions that might not have otherwise occurred as soon. On the other hand, society pays a higher price than it would if anyone were allowed to copy those inventions and distribute the benefits in the most economically efficient way.
There are various safeguards in the law that make this trade more appealing to the public. Since the monopoly rights are so strong (there is no "fair use", for example), there is a high level of scrutiny before granting them. And there are high standards that must be met ("subject-matter eligibility", "novelty", "non-obviousness", "definiteness", "enablement"). And even after a patent is granted, it is contestable (but, litigation is expensive). The big safeguard is that patents are limited to a term of 20 years (in the U.S.) and after that the invention is dedicated to the public.
I am pretty sure that the 20 year term is non-ideal. For some types of inventions (e.g., those requiring only a small investment of time or money to innovate) society may be granting inventors too long of a term. For other types of inventions, the term may be too short (e.g., where an innovation required a huge amount of investment). As you pointed out, the effects on society are hard to calculate.
Because the rules are "one size fits all", I am pretty sure we don't have an ideal system. However, I don't know if adding more rules would make the system better or worse. At least interested parties can petition for changes either through the courts or through the legislatures.
Valter D. Longo and Chia-Wei Cheng are the "inventors". This is a blatant attempt at taking advantage of the indifference of the uspo and the ignorance of the public to what is going on at the uspo. This is despicable and I think we as somewhat more informed participants in this little thing called civilization need to do more to have our voices heard and vilify those who keep taking advantage of society. This includes those that at the uspo that are actually reading these patents and issuing them. Can anyone find out who they are?
On another note, I wonder if there is any form of moral hazard in the uspo office, possibly in the form of workers being incentivized to issue patents, or workers from certain companies going to work for patent offices that are sought out by those companies for their patents. Maybe offices or workers are granting patents for the sake of being able to show a high number of patents issued at the end of the year. Maybe this makes them look good when it comes time for performance review. idk. I do know that something needs to change, a change that hopefully adds transparency and holds people responsible. Should we write our congress representatives? (lol)
This post shows that you, too, are a member of "the public" which is ignorant "to what is going on at the uspo." It's the USPTO, by the way.
Can anyone find out who they are?
Of course you can. You can find the examiner who reviewed this patent, you can find the references cited in the rejection, which precipitated the amendments to the claims. You can even find his phone number and email address.
I wonder if there is any form of moral hazard in the uspo office,
possibly in the form of workers being incentivized to issue patents
They are incentivized to reject applications multiple times, to force an RCE, etc. via a point-based performance metric. Prosecuting a patent is not a walk in the park. Rejections get you points. Allowances do not get you points.
Maybe offices or workers are granting patents for the sake of being
able to show a high number of patents issued at the end of the year.
This shot in the dark is totally baseless, and incorrect.
I do know that something needs to change, a change that
hopefully adds transparency and holds people responsible.
How transparent do you want it? Do you want every office action made public? Do you want all communication between the examiner and the applicant to be made public? Do you want all responses to the rejections and references asserted as prior art for purposes of anticipation (novelty) or obviousness (inventive step) to be listed out for the entire world to see?
> This post shows that you, too, are a member of "the public" which is ignorant "to what is going on at the uspo." It's the USPTO, by the way.
Thanks for ignoring the qualifier I used, how convenient for your own accusation.
> You can even find his phone number and email address.
Glad to hear this, but after a quick glance at the document I still cant find it. I'll try again.
> They are incentivized to reject applications multiple times
How? A source would be nice but the explanation will suffice.
> This shot in the dark is totally baseless, and incorrect
Could be incorrect, therefor the qualifier, again...
>OH WAIT. IT ALREADY IS
Where? Thanks for correctly informing another citizen. Your civility was much appreciated.
Also, I would like to reiterate my call for responsibility. Although you said the examiners and applicants all known, I still dont think they are held accountable enough for the bad patents that get issued.
I think you are mixing up 'Patent application' vs 'Patent'. Anyone can submit a patent application. Whether it makes it through and is granted is a different story. Also the title and abstract of the invention don't really mean much. The claims are what defines the patentable invention.
This is a fair explanation of what is going on here under the hood. The innovation here has to do with how to get funding into an area that Big Pharma has ignored.
------------
One of the more recent innovations in calorie restriction research has nothing to do with the science, and everything to do with figuring out how to pull more funding into the field. There is never enough funding for research in any field: going by how funds flow through our societies, it is easy to say that to a first approximation no-one really cares about progress in medicine. Bread and circuses, yes. Better technologies, better understanding of biology, and less disease, no. There is also a large difference between the funds available for non-commercial research versus money available and interested in investment in for-profit ventures. The latter is at least ten times the former, and much more easily arranged as well. Writing grants and raising philanthropic funding is a considerably harder job than pitching angels and venture firms; more effort for fewer dollars at the end of the day. But without the funding for non-profit research initiatives, there will be no new technologies ready to be carried forward in for-profit companies. It is one of the great frustrations of patient advocacy to know that the owners of countless millions of dollars are sitting on their hands, waiting for viable biotech companies, while the important research projects that will generate those companies struggle to raise hundreds of thousands to sustain shoestring budgets.
Calorie restriction is a particular challenge in this context. It is a lifestyle choice, not a drug or an antibody or something else that the medical industry understands how to package, market, and sell. It is nothing more than eating sensibly and eating less. Anyone can choose to do it. It is free and straightforward and well-documented. Yet the effects on long-term health and aging in ordinary individuals are much larger than anything that can be generated by the presently available panoply of drugs and other interventions. That, I should say, is more a statement on the poor quality of present medicine when it comes to treating aging as a medical condition than it is on the benefits of calorie restriction. It is a case of something being better than nothing: no presently available medicine deliberately addresses the root causes of aging, for all that the first therapies that will do that are in development at various stages. The nature of calorie restriction means that there has been little to no for-profit investment aiming to better characterize its benefits. Rather, all that funding was directed towards mapping the biochemistry and haphazardly testing the established drug libraries to find something that triggered any of the same effects. The search for such calorie restriction mimetics is well documented elsewhere, so I won't dwell on that, beyond noting that the outcome of ten to fifteen years of work and a great deal of money is, so far, nothing of any practical use.
So to calorie restriction itself, and how to obtain for-profit funding for research into eating less, and eating less in an effective way. The innovators here are Valter Longo and colleagues, who have achieved the goal of pulling in for-profit funding on the backs of turning specific implementations of fasting and low-calorie diets into FDA-approved therapies, such as an adjuvant in cancer treatment. The magic of regulation means that companies can manufacture a medical diet on the basis of research, and then use the barriers set up via intellectual property and regulatory pronouncements to charge an inordinate amount for what is, basically, a little bit of food that anyone could throw together after reading the papers to obtain the target calories, protein, micronutrient levels, and so on. That in turn means that the principals of these companies are willing to pay for the supporting research. On the one hand it's a depressing example of the distorted priorities that emerge from regulation of medicine, on ...
It is regrettable that funding systematically favors for-profit research. I tried looking for the sources of funding Valter D. Longo used for his papers because I doubt he didnt use any government grants, especially after you iterated the challenges calorie restriction research faces. Unfortunately my superficial search didnt find it and I cant spend more time at the moment.
It doesn't seem too different from the Atkins diet. Bodybuilders do all kinds of cycled carbohydrate restriction although they don't usually lowball their protein intake.
This issued as US patent 9,386,790, so it's not just an application.
Most can keep fasting intermittently without infringing at least claim 1, typically the broadest claim. If you don't have (and know you have) "pancreatic beta cell destruction," you don't infringe. Even then, if you only cut to 51% of your normal intake or more, you don't infringe. Even then, if you restrict sugar but not protein, you don't infringe. Even then, if your re-feed at greater than 100% of your normal diet (which is common), you don't infringe.
3.) In the "Search for Application" form, select the radio button for 'patent number'
4.) Type '9,386,790', without quotes, into the 'Enter Number' text box.
5.) Click on the SEARCH button.
This will take you to the patent page with each of the tabs having different information about the patent. If you get a notification that the system is busy, just wait a few seconds and try again.
These same steps with different patent and application numbers can be used in the future if you run into other US patent related inquiries.
For a claim to be literally infringed, every element of the claim must be present in the allegedly infringing use. Since the first element of the first claim is "identifying a subject exhibiting symptoms...", that element would need to be present in the private citizen's use as well. A single private citizen following a dietary protocol is probably not "identifying a subject exhibiting symptoms..."
Further, the language "administering multiple cycles of a diet protocol to the subject" seems to imply that multiple persons are needed in order to carry out this method, so it could be argued that a single private citizen could not infringe the claim by himself in any circumstances.
The same reasoning applies to all of the other claims since all of the claims as issued depend from claim 1 or from claims 16, 25, or 28, which have similar limiting language.
I am really curious how the first method/process claim was granted.
'1. A method of treating a symptom of diabetes, the method comprising:
identifying a subject exhibiting symptoms caused by pancreatic beta cell destruction, the subject having a normal caloric intake; and administering multiple cycles of a diet protocol to the subject wherein a fasting mimicking diet is provided for a first time period and a re-feeding diet is provided for a second time period, the fasting mimicking diet providing less than about 50% of the normal caloric intake of the subject with both protein restriction and sugar restriction and the re-feeding diet providing 60-100 percent of the normal caloric intake of the subject, depending on a need to lose weight wherein the first time period is from 2 days to 6 days and the second time period is from 7 days to 85 days.'
This seems like un-patentable subject matter based on USPTO guidelines (https://www.uspto.gov/sites/default/files/web/offices/pac/da...). It seems to me that it fails the machine or transformation test for a process patent (https://en.wikipedia.org/wiki/Machine-or-transformation_test). The only way I could reason that it was patentable is if the 'diet protocol' has to be followed strictly based on the definition in the patent. The diet protocol has a long section with very specific micro-nutrient content. So that is the 'product', a calorie restricted diet with a narrowly defined micronutrient supplementation.
If there is anyone well versed, what is your opinion on the patentability of the first claim?
Patentable subject matter is explicitly broad, and the machine or transformation test is only a rough guideline, as your link points out. Most patents eventually get approved, but when the patent office does reject a patent it is not usually for subject matter.
First of all, a patent is presumed valid unless proven otherwise. (35 U.S.C. §282). However, this is challengable. In litigation, the patentee would argue that the invention at issue is a process and that, in the language of your citation, is one to "transform a particular article into a different state." Here the "article" in question is a "subject exhibiting symptoms..." who is transformed into the state of being a subject who has been treated.
The scope of the invention is stated by the claims, not what is disclosed in the specification. So, as you wrote, the "diet protocol" does have to be followed exactly, and all other other elements of the claim need to be present in order for there to be literal infringement of that claim.
Not just diabetes, it appears to enhance the efficacy (such as it is) of cytotoxic chemotherapy as well.
Not sure how someone would actually file an infringement lawsuit for not eating, though. This therapy has a little tiny bit of prior art (e.g. several hundred million years).
Patent applications and prosecutions are difficult, much more difficult than I think most realize. Try it yourself (be sure to have at least a spare $13000 lying around) and come back in a year or so with your scars, if you're one of the folks randomly sniping about the process. It's far, far, far from perfect; but it evolves (see for example Myriad, Prometheus, and Alice for important recent cases) and the worst mistakes do get corrected.
They wouldn't file infringement suits for not eating. They'd file them against people who build a business out of controlling the diet of diabetic patients in this particular way. And given that it's been studied, health insurance companies are willing to pay for diabetic patients to have their diet controlled in this particular way.
IMO, it's not an attempt to monopolize the results of the research. Rather, it's an attempt to monopolize extracting money out of health insurance companies that are only willing to pay for proven treatments.
It's probably my ignorance and preconceived notions showing but this seems so bizarre when contrasted with something like medication. If patenting methods is possible could I patent a particular type of high intensity interval training?
Not a patent dude, and I just skimmed. The things that stood out to me were "method of identifying," which is not just the diet, but knowing you have beta cell damage, i.e. "the dude has diabetes." And also, a list of nutrients seemed relevant.
Health insurance companies will pay for proven-effective diabetes treatments. This prevents competitors from free-riding on the effectiveness proof of this diabetes treatment to charge money to health insurance companies.
Before insulin was discovered, all manner of restricted diets were tried - all they did was postpone the inevitable.
A detailed search of prior art from 1800 should kick this application to the curb.
Allen was not the first person to recommend treatment of diabetes by diet; as Ramachandran and Viswanathan (1998) point out, dietary treatment of diabetes mellitus was used in ancient Egypt as long ago as 3,500 B.C., and was being used in India about 2,500 years ago. These authors note that in the eighteenth century, John Rollo had observed that glycosuria in diabetics could be reduced if sufferers of diabetes mellitus reduced the quantity of their food consumed. However, Allen became famous in his own day for his recommendations, and Allen and his co-workers published their work on the diabetic diet in 1919, in a work entitled "Total Dietary Regulation in the Treatment of Diabetes". Today, however, diabetologists would take quite different views on this subject to those promoted by Allen. Indeed, Joslin, in 1922, suggested different diet recommendations to those of Allen, suggesting a reduction of fat rather than carbohydrate, with the overall goal of reduction in calorie intake (Hockaday, 1981). Allen has been named as one of the two leading diabetologists, along with Elliott P. Joslin, in the period 1910 to 1920.
Apparently it was used way before that period as well.
51 comments
[ 2.9 ms ] story [ 117 ms ] threadI think that "method" patents don't get enough scrutiny by the public. If you read claim one, what they are preventing is: anyone identifying someone with diabetes and then putting that person on a calorie restricted diet.
It's not clear to me why the government should grant a monopoly on this technique, even from a theoretical standpoint.
How is that going to be enforced especially considering fasting is part of Islam, Hinduism, Jainism and Buddhism?
Telling a patient to fast is basically a clinical practice. Almost like checking blood pressure. No actual supplies needed, just behavioral counseling.
By the same logic, could I patent checking blood pressure?
From the language, it would suggest that you'd have to administer this as a treatment for diabetes. And it's a very specific form of fasting, not fasting in general.
1. This link is to the as-filed application. The recited claims are not what ultimately issued. Linking to the application rather than the granted patent is dubious. https://www.google.com/patents/US9386790
2. A patent practitioner will utilize method claims in order to apply something known in the art, such as general fasting, in a new and novel manner. This does NOT cover plain-ole fasting. You can fast without violating this patent. What you cannot do without a license to the patent is perform the method in its entirety.
The independent claim recites:
The take-aways form the claim language are:A. This is a method of treating a symptom of diabetes. In order to infringe, you must be treating diabetes by performing the method.
B. You must actively identify a subject exhibiting symptoms caused by pancreatic beta cell destruction, and the subject must have a normal caloric intake. If you are an individual who is fasting to treat your diabetes, you don't infringe by performing this method. You did not identify a subject exhibiting symptoms caused by pancreatic beta cell destruction. You are merely fasting.
C. You must administer multiple cycles of this fasting and refeeding, within the exact caloric-intake ranges required by the claim, and within the exact time frame required by the claim.
TL;DR: It's toothless for all except treatment centers which diagnose and identify this "subject exhibiting symptoms caused by pancreatic beta cell destruction" which could potentially prescribe this very specific dietary regime to "treat a symptom of diabetes."
This strikes me as unduly harsh for an honest mistake at worst. Updated information is always preferable, but I have a hard time seeing any bad intent in the original comment.
Does it not say "administer"?
I will say that you've sort of missed what I think is the important part:
We as a society have decided that it's acceptable to legally bar medical practitioners from performing life saving treatment of sick individuals.
The only explanations I've heard for why that might not be crazy has unfortunately been simple and hand-wavey. Specifically I've heard that patents protect innovators, and the idea is that protecting innovators by intentionally granting them a limited monopoly on the use of their invention will create a society more likely to produce new innovations. The idea is that despite clear negatives, patents offer a net benefit to society.
The problem is I can easily imagine scenarios for either side of that argument, but I've never heard a comprehensive argument in favor of the current way of doing things. I also can't help but notice that patents often protect the establishment by granting the wealthy more monopoly power. Given that the legal system is in many ways captured by the wealthy establishment, I question whether the patent system continues to exist because it is truly beneficial to all or because it benefits the elite that also extert significant power over the legal system.
If the latter were true, then it could also be said that patents are another example of the establishment hurting the masses for their own gain. And in this case (again, as you pointed out the practical effect of this example may be small), the patent system is creating a risky legal situation for those who would try to provide medical care for sick members of our society.
As an anecdote, 3D printers were $30k until several major patents expired. Then small companies formed and in less than 10 years we created excellent 3D printers that cost $329 (I just bought one of those).
I can't help but wonder what the cumulative effect of artificial monopolies is on our society. Because it's invisible it's hard to calculate, but it's clear to me the effect is large.
I'm open to any insight into these matters. My plan is to promote the voluntary open sourcing of engineered works, but I'd sure love to stop supporting the patent system in the first place (I think).
There are various safeguards in the law that make this trade more appealing to the public. Since the monopoly rights are so strong (there is no "fair use", for example), there is a high level of scrutiny before granting them. And there are high standards that must be met ("subject-matter eligibility", "novelty", "non-obviousness", "definiteness", "enablement"). And even after a patent is granted, it is contestable (but, litigation is expensive). The big safeguard is that patents are limited to a term of 20 years (in the U.S.) and after that the invention is dedicated to the public.
I am pretty sure that the 20 year term is non-ideal. For some types of inventions (e.g., those requiring only a small investment of time or money to innovate) society may be granting inventors too long of a term. For other types of inventions, the term may be too short (e.g., where an innovation required a huge amount of investment). As you pointed out, the effects on society are hard to calculate.
Because the rules are "one size fits all", I am pretty sure we don't have an ideal system. However, I don't know if adding more rules would make the system better or worse. At least interested parties can petition for changes either through the courts or through the legislatures.
On another note, I wonder if there is any form of moral hazard in the uspo office, possibly in the form of workers being incentivized to issue patents, or workers from certain companies going to work for patent offices that are sought out by those companies for their patents. Maybe offices or workers are granting patents for the sake of being able to show a high number of patents issued at the end of the year. Maybe this makes them look good when it comes time for performance review. idk. I do know that something needs to change, a change that hopefully adds transparency and holds people responsible. Should we write our congress representatives? (lol)
edit: wording, punctuation, hoopla
OH WAIT. IT ALREADY IS.
Thanks for ignoring the qualifier I used, how convenient for your own accusation.
> You can even find his phone number and email address.
Glad to hear this, but after a quick glance at the document I still cant find it. I'll try again.
> They are incentivized to reject applications multiple times
How? A source would be nice but the explanation will suffice.
> This shot in the dark is totally baseless, and incorrect
Could be incorrect, therefor the qualifier, again...
>OH WAIT. IT ALREADY IS
Where? Thanks for correctly informing another citizen. Your civility was much appreciated.
Also, I would like to reiterate my call for responsibility. Although you said the examiners and applicants all known, I still dont think they are held accountable enough for the bad patents that get issued.
------------
One of the more recent innovations in calorie restriction research has nothing to do with the science, and everything to do with figuring out how to pull more funding into the field. There is never enough funding for research in any field: going by how funds flow through our societies, it is easy to say that to a first approximation no-one really cares about progress in medicine. Bread and circuses, yes. Better technologies, better understanding of biology, and less disease, no. There is also a large difference between the funds available for non-commercial research versus money available and interested in investment in for-profit ventures. The latter is at least ten times the former, and much more easily arranged as well. Writing grants and raising philanthropic funding is a considerably harder job than pitching angels and venture firms; more effort for fewer dollars at the end of the day. But without the funding for non-profit research initiatives, there will be no new technologies ready to be carried forward in for-profit companies. It is one of the great frustrations of patient advocacy to know that the owners of countless millions of dollars are sitting on their hands, waiting for viable biotech companies, while the important research projects that will generate those companies struggle to raise hundreds of thousands to sustain shoestring budgets.
Calorie restriction is a particular challenge in this context. It is a lifestyle choice, not a drug or an antibody or something else that the medical industry understands how to package, market, and sell. It is nothing more than eating sensibly and eating less. Anyone can choose to do it. It is free and straightforward and well-documented. Yet the effects on long-term health and aging in ordinary individuals are much larger than anything that can be generated by the presently available panoply of drugs and other interventions. That, I should say, is more a statement on the poor quality of present medicine when it comes to treating aging as a medical condition than it is on the benefits of calorie restriction. It is a case of something being better than nothing: no presently available medicine deliberately addresses the root causes of aging, for all that the first therapies that will do that are in development at various stages. The nature of calorie restriction means that there has been little to no for-profit investment aiming to better characterize its benefits. Rather, all that funding was directed towards mapping the biochemistry and haphazardly testing the established drug libraries to find something that triggered any of the same effects. The search for such calorie restriction mimetics is well documented elsewhere, so I won't dwell on that, beyond noting that the outcome of ten to fifteen years of work and a great deal of money is, so far, nothing of any practical use.
So to calorie restriction itself, and how to obtain for-profit funding for research into eating less, and eating less in an effective way. The innovators here are Valter Longo and colleagues, who have achieved the goal of pulling in for-profit funding on the backs of turning specific implementations of fasting and low-calorie diets into FDA-approved therapies, such as an adjuvant in cancer treatment. The magic of regulation means that companies can manufacture a medical diet on the basis of research, and then use the barriers set up via intellectual property and regulatory pronouncements to charge an inordinate amount for what is, basically, a little bit of food that anyone could throw together after reading the papers to obtain the target calories, protein, micronutrient levels, and so on. That in turn means that the principals of these companies are willing to pay for the supporting research. On the one hand it's a depressing example of the distorted priorities that emerge from regulation of medicine, on ...
It is regrettable that funding systematically favors for-profit research. I tried looking for the sources of funding Valter D. Longo used for his papers because I doubt he didnt use any government grants, especially after you iterated the challenges calorie restriction research faces. Unfortunately my superficial search didnt find it and I cant spend more time at the moment.
http://www.telegraph.co.uk/wellbeing/diet/why-weve-all-been-...
https://thequantifiedbody.net/fast-mimicking-diet/
Most can keep fasting intermittently without infringing at least claim 1, typically the broadest claim. If you don't have (and know you have) "pancreatic beta cell destruction," you don't infringe. Even then, if you only cut to 51% of your normal intake or more, you don't infringe. Even then, if you restrict sugar but not protein, you don't infringe. Even then, if your re-feed at greater than 100% of your normal diet (which is common), you don't infringe.
1.) Navigate to http://portal.uspto.gov/pair/PublicPair
2.) Enter the CAPTCHA if prompted
3.) In the "Search for Application" form, select the radio button for 'patent number'
4.) Type '9,386,790', without quotes, into the 'Enter Number' text box.
5.) Click on the SEARCH button.
This will take you to the patent page with each of the tabs having different information about the patent. If you get a notification that the system is busy, just wait a few seconds and try again.
These same steps with different patent and application numbers can be used in the future if you run into other US patent related inquiries.
Further, the language "administering multiple cycles of a diet protocol to the subject" seems to imply that multiple persons are needed in order to carry out this method, so it could be argued that a single private citizen could not infringe the claim by himself in any circumstances.
The same reasoning applies to all of the other claims since all of the claims as issued depend from claim 1 or from claims 16, 25, or 28, which have similar limiting language.
'1. A method of treating a symptom of diabetes, the method comprising: identifying a subject exhibiting symptoms caused by pancreatic beta cell destruction, the subject having a normal caloric intake; and administering multiple cycles of a diet protocol to the subject wherein a fasting mimicking diet is provided for a first time period and a re-feeding diet is provided for a second time period, the fasting mimicking diet providing less than about 50% of the normal caloric intake of the subject with both protein restriction and sugar restriction and the re-feeding diet providing 60-100 percent of the normal caloric intake of the subject, depending on a need to lose weight wherein the first time period is from 2 days to 6 days and the second time period is from 7 days to 85 days.'
This seems like un-patentable subject matter based on USPTO guidelines (https://www.uspto.gov/sites/default/files/web/offices/pac/da...). It seems to me that it fails the machine or transformation test for a process patent (https://en.wikipedia.org/wiki/Machine-or-transformation_test). The only way I could reason that it was patentable is if the 'diet protocol' has to be followed strictly based on the definition in the patent. The diet protocol has a long section with very specific micro-nutrient content. So that is the 'product', a calorie restricted diet with a narrowly defined micronutrient supplementation.
If there is anyone well versed, what is your opinion on the patentability of the first claim?
The scope of the invention is stated by the claims, not what is disclosed in the specification. So, as you wrote, the "diet protocol" does have to be followed exactly, and all other other elements of the claim need to be present in order for there to be literal infringement of that claim.
Not sure how someone would actually file an infringement lawsuit for not eating, though. This therapy has a little tiny bit of prior art (e.g. several hundred million years).
Patent applications and prosecutions are difficult, much more difficult than I think most realize. Try it yourself (be sure to have at least a spare $13000 lying around) and come back in a year or so with your scars, if you're one of the folks randomly sniping about the process. It's far, far, far from perfect; but it evolves (see for example Myriad, Prometheus, and Alice for important recent cases) and the worst mistakes do get corrected.
JMHO
IMO, it's not an attempt to monopolize the results of the research. Rather, it's an attempt to monopolize extracting money out of health insurance companies that are only willing to pay for proven treatments.
Overall though ... WTF?
Stay away from food and insulin resistance goes down. Duh. Everyone knows this.
And you can't exactly go around sending people cease and desist letters saying "You're not eating, you're violating our patent."
What's the incentive to even file this?
Starvation is the way they used to treat the disease in the early part of the twentieth century.
https://en.wikipedia.org/wiki/Frederick_Madison_Allen
Allen was not the first person to recommend treatment of diabetes by diet; as Ramachandran and Viswanathan (1998) point out, dietary treatment of diabetes mellitus was used in ancient Egypt as long ago as 3,500 B.C., and was being used in India about 2,500 years ago. These authors note that in the eighteenth century, John Rollo had observed that glycosuria in diabetics could be reduced if sufferers of diabetes mellitus reduced the quantity of their food consumed. However, Allen became famous in his own day for his recommendations, and Allen and his co-workers published their work on the diabetic diet in 1919, in a work entitled "Total Dietary Regulation in the Treatment of Diabetes". Today, however, diabetologists would take quite different views on this subject to those promoted by Allen. Indeed, Joslin, in 1922, suggested different diet recommendations to those of Allen, suggesting a reduction of fat rather than carbohydrate, with the overall goal of reduction in calorie intake (Hockaday, 1981). Allen has been named as one of the two leading diabetologists, along with Elliott P. Joslin, in the period 1910 to 1920.
Apparently it was used way before that period as well.