I wonder why their own patent says the combination of Berberine and Ca-AKG has beneficial effects in C. elegans and mice?
.1. A method of extending lifespan in a subject in need thereof comprising administering to the subject a therapeutically effective amount of berberine, a vitamin A compound, and a-ketoglutarate (AKG).
..and other similar claims
This was the original claim 1. You can find the prosecution history of the patent application here. The applicant amended the claims before it reached an examiner. For reasons unknown to us, they canceled claims for the combination of berberine and AKG, and instead went ahead with claims for either vitamin A plus AKG or vitamin D plus AKG.
We can only speculate on why they chose to drop the berberine claims before the US examiner had even expressed an opinion about them. In Global Dossier, we find that they took the same strategy in the European Patent Office and in Japan (probably others too, I didn’t look).
Don’t read too much into the claims for combinations. It may only be a patent strategy and not really that important scientifically. AKG by itself would not be patentable because it is an unmodified natural product and because of prior art. Combining AKG with other things has a chance of being patentable if the combination is not obvious.
We can see how the strategy has played out so far.
The US examiner required them to choose either vitamin A plus AKG or vitamin D plus AKG for further examination. (This is a common practice; the applicant can go for the things they did not choose in a separate application later). They chose vitamin D plus AKG. So far, the US examiner doesn’t seem to think that using AKG to extend healthspan was really a new idea at the time the application was filed. The examiner is also not convinced that there is anything special about the combination of vitamin D plus AKG. Of course that is just one person’s opinion, which could be overcome with further argumentation or it may be overturned on appeal.
I suspect that they dropped the berberine claims because both berberine and AKG were previously known or suspected to be beneficial for aging and, therefore, by patent legal precedent, the examiner could argue that it would be obvious to combine them. Maybe they wanted to avoid that argument for now. So their strategy of foregoing the berberine claims says nothing about whether the combination actually works. Scientifically though, the actual data in the application does seem to support their use in combination.