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  • Writer's pictureShelly Albaum

Inter Partes Review Oral Hearing Transcript

The PTAB website offers us a 70-page transcript of the oral arguments before in the Inter Partes Review. You can read the transcript here:

I don't have time to study it closely today -- I haven't even read it all -- so I will just make the trascript available now, and maybe have a follow-up post with some analysis.

But here are a couple excerpts that will give a flavor of the transcript:

COUNSEL FOR ELYSIUM: Now, the dispute here really comes down to one of claim construction. So oddly, it comes -- involves claim construction of a very innocuous seeming phrase. The phrase is "a pharmaceutical composition comprising nicotinamide riboside." On its face this phrase seems to be very straightforward in its language. As we said, pharmaceutical compositions include compositions such as food. Comprising is just a transition word that usually in the art means including. And nicotinamide riboside is a well- defined molecule in the art. Despite the plain language of this claim being very straightforward, patent owner has proposed a construction in which they have added the limitation that would require nicotinamide riboside to be in the formulation as the active agent.

JUDGE MITCHELL: Counsel, what do we make of pharmaceutical in that preamble pharmaceutical composition? Does that not add some weight to patent owner's argument?

COUNSEL FOR ELYSIUM: I don't think so. So pharmaceutical composition, to the extent it is a limiting -- to the extent it is limiting would imply that the composition as a whole has some kind of pharmaceutical property. It doesn't necessarily mean that any particular agent in the pharmaceutical composition has a pharmaceutical -- has a pharmaceutical effect.

JUDGE MITCHELL: But the only thing they have named, at least in claim 1, is the nicotinamide riboside. So wouldn't the assumption be when we're reading this claim, if it's a pharmaceutical composition, that we are talking about that as an active agent, the nicotinamide riboside?


JUDGE SCHNEIDER: Counsel, going back to the term "pharmaceutical," I note that patent owner has submitted Exhibit 2004 which is a McGraw-Hill scientific dictionary. And there the definition for pharmaceutical includes a chemical produced industrially for a medicinal drug which is useful in preventive or therapeutic treatment of a physical, mental or behavioral condition. Now, that would sort of imply that you have got to actually make something up rather than milk which just occurs naturally. How does that fit into your definition that milk is a pharmaceutical composition?

COUNSEL FOR ELYSIUM: So first it's pretty clear that even from claim 2 of this which says that the nicotinamide riboside is isolated from a natural or synthetic source that these claims don't actually require the physical or chemical manufacture of any of the agents within here. I think what ends up happening is the claims -- I mean, we need to look at what the patent owner says himself. And in claim 4 he expressly says that it's a formulation that comprises a food. And I think when you look at that and in the specification where it talks about oral formulations can be in the form of food, then I think especially when you are talking about something like this skim milk or buttermilk where there are pieces removed from the food by essentially the hand of man in order to create a different formulation, then you are looking at something that if it's used pharmaceutically, then it could be a pharmaceutical formulation. And also, I just wanted to add that that definition, I don't think, is really applicable here. And that's a definition for the word "pharmaceutical," which is a noun. That's one thing. I think in this case, a pharmaceutical composition, the pharmaceutical is being used as an adjective to describe the composition itself. In other words, getting the intended use of the composition for pharmaceutical purposes. Not that it necessarily contains a particular pharmaceutical.

JUDGE PAULRAJ: Counsel, you bring up the intended use argument. I mean, one of the well established principles about intended use or at least preamble limitations such as this is that if it does breathe life and meaning into the rest of the claims, it should be given some weight. I'm having some trouble as to why we should ignore pharmaceutical all together. If the idea here is that you are trying to treat some disease and you said the claims don't require a disease, require any particular disease to be treated, but the specification, the very first paragraph of the specification talks about pellagra and some other diseases, why shouldn't we consider that in the context of interpreting this claim?


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