Patent application by USC: Fasting condition as dietary treatment of diabetes

For those who want to research this further (including full claim text, history, who examined it, images of the submitted documents, etc):

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.

Could a private citizen following a dietary protocol actually be sued for infringement of a patent? Seems absurd, not to mention highly unenforceable.

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?

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?

OH WAIT. IT ALREADY IS.

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.

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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 the other one feels a certain admiration for Longo et al for having successfully hacked the system to fund the useful results they have produced these past few years. Quantifying the degree to which fasting alters the immune system, and quantifying the degree to which low-calorie diets and fasting are effectively equivalent in altering metabolism, are both helpful new information for those who practice forms of calorie restriction and intermittent fasting. In any case, here is a pointer to the less useful outcome from all of this, which is to say the medical diet. It comes across as a bad parody of itself, but that seems fairly true of most medical diet products - you can go look at ProLon yourself.

"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.

> you must be treating diabetes by performing the method

Does it not say "administer"?

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).

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.

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.

Overall though ... WTF?

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.

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...

I really wish more people knew how to read a patent. These knee-jerk (incorrect) reactions only serve to generate hysteria.

If I'm not mistaken, you can make/do a patented thing as an individual all you want, you just can't commercialize it.

> 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.

It granted, indeed. Albeit with a slightly narrower claim scope. See my analysis of the issued independent claim.