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  • Shelly Albaum

Elysium's IPR Petition DENIED


Elysium has challenged two Dartmouth patents before the PTAB: the '086 patent and the '807 patent. The PTAB yesterday DENIED Elysium's challenge to the '807 Patent. We're likely to hear back soon on the '086 Patent, and I would guess the response will be similar. You can read the PTAB's denial here:

PTAB's Denial of IPR for '807 Patent

We covered Elysium's original petition and Dartmouth's (ChromaDex's) response here.

The short story is that the '807 patent claims "isolated" nicotinamide riboside, and the PTAB rejected Elysium's claim that nicotinamide riboside is already "isolated" in cow's milk. If the cow's milk is not at least 25% NR, says the PTAB, then the NR has not yet been isolated, and therefore:

"Having considered the arguments and the evidence presented, for the reasons described below, we determine that Petitioner has not demonstrated that there is a reasonable likelihood that it would prevail with respect to at least one of the claims challenged by the Petition. Accordingly, we decline to institute an inter partes review."

The PTAB's ex parte process to reconsider patents is notorious and has been called a "graveyard" for patents, and a challenge is currently pending before the SCOTUS.

That means it doesn't take much to convince the PTAB to initiate a review, and once a review is initiated, a frequent outcome is the revocation of one or more claims.

That Elysium's petition falls into the small set of IPR review requests that is denied from the outset indicates that Elysium's challenge to this patent is farfetched. How farfetched? Let's see what the PTAB has to say.

Elysium's primary challenge to the '807 patent is that "isolated" nicotinamide riboside isn't a new invention because it already exists in milk. The PTAB says that the Nicotinamide Riboside in the milk is not yet "isolated:"

"We determine that the broadest reasonable interpretation of the term “isolated” requires that the nicotinamide riboside is separated or substantially free from at least some of the other components associated with the source of the molecule such that it constitutes at least 25% (w/w) of the composition."

The PTAB considered Elysium's argument that: “[t]he milk disclosed in Goldberger et al. inherently comprises a composition comprising isolated nicotinamide riboside in combination with tryptophan and nicotinamide” and that "the nicotinamide riboside in the Goldberger et al.’s skim milk is 'isolated' because it is removed from the cow and further isolated during the process of converting the whole milk from the cow to skim milk by removing fat."

The PTAB rejected Elysium's interpretation on these grounds:

we have construed the claim term “isolated” when read in light of the Specification of the ’807 patent to require that the nicotinamide riboside be separated or substantially free from at least some of the other components associated with the source of the molecule such that it constitutes at least 25% (w/w) of the composition. Although Petitioner has offered evidence that the skim milk disclosed in Goldberger et al. comprises nicotinamide riboside that has been separated from fat, it does not teach that the nicotinamide riboside comprises at least 25% of the skim milk, nor do the other Trammell references on which Petitioner relies to show the inherent presence of nicotinamide riboside in Goldberger et al.’s skim milk. See Pet. 10. In fact Trammell I suggests that the amount of nicotinamide riboside present in raw cow’s milk is less than 25%. See Ex. 1007, 3 (Milk samples contain 4.3 ± 2.6 μmol of nicotinamide riboside/liter.). Thus on the record before us, Petitioner has not shown that nicotinamide riboside in skim milk is “isolated” as required by claim 1...

In consideration of the foregoing, it is hereby:

ORDERED that the Petition is denied as to all challenged claims of the ’807 patent and no trial is instituted.

What About The '087 Patent

I would expect that the 25% interpretation in the '807 patent will prove fatal to Elysium's challenge to the '086 patent, as well -- at least with respect to Claim 2 -- because both patents include an "isolation" component, and the prior art cited by Elysium is also the Goldberger studies.

But as a reminder, these are the arguments that Dartmouth/ChromaDex asserted in opposition to IPR for the '086 patent:

First, Petitioner has not provided any evidence that either of its prior art references of the proposed Grounds discloses a pharmaceutical composition as recited in claim 1 and in each of the dependent claims of the ’086 patent. Because neither prior art reference of the proposed Grounds discloses a pharmaceutical composition as described and claimed in the ’086 patent, Petitioner cannot establish that the references anticipate claim 1 of the ’086 patent.

Second, Petitioner has not provided any evidence that either of its prior art references of the proposed Grounds discloses the essential claim element of a pharmaceutical composition comprising nicotinamide riboside formulated “in admixture with a carrier” as claimed in independent claim 1 of the ’086 patent. Because neither asserted prior art reference discloses nicotinamide riboside formulated in admixture with a pharmaceutically acceptable carrier as disclosed in the ’086 patent, Petitioner cannot establish that the references anticipate claim 1 of the ’086 patent.

Third, Petitioner has not provided any evidence that either of its prior art references of the proposed Grounds discloses compositions comprising nicotinamide riboside that “is isolated from a natural or synthetic source,” as required by claim 2 of the ’086 patent. Petitioner instead relies on an improper claim construction and questionable expert testimony for its argument that nicotinamide riboside present in milk or buttermilk is “isolated” from a natural source when milk is removed from a cow. Petitioner cannot establish that the references anticipate claim 2 of the ’086 patent.

Fourth, Petitioner has not provided any evidence that either of its prior art references of the proposed Grounds discloses a pharmaceutical composition comprising nicotinamide riboside that “increases NAD+ biosynthesis upon oral administration,” as required by dependent claim 5 of the ’086 patent. Petitioner instead relies on an argument regarding milk that was already considered by the Examiner and overcome during prosecution of the parent application to the ’086 patent. Petitioner cannot establish that the references anticipate claim 5 of the ’086 patent. (emphasis added)

They all seem strong to me. We'll see.

#CDXC #ChromaDex #ElysiumHealth #Litigation

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