[rosspackard]

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?

[bdowling]

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.

[jaredklewis]

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.