Before ZHENYU YANG, TINA E. HULSE, and TAWEN CHANG, Administrative Patent Judges.

The Trustees of Columbia University in the City of New York (“Patent Owner”) did not file a Preliminary Response to the Petition.

We determined that Petitioner had shown a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’432 Patent and instituted an inter partes review of all challenged claims on all asserted grounds.

Patent Owner then informed the Board that it “has abandoned the contest in IPR2024- 00312.” Id. at 1.

Patent 9,486,432 B2 For PETITIONER: Jad A. Mills Michael T. Rosato Matthew Bresnahan

As to Patent Owner’s argument that “Petitioner failed to establish a motivation due to ... its reliance on speculation and conjecture (‘likely’),” the Decision explains why, “[a]t this stage of the proceeding, we find Petitioner has provided sufficient evidence, in the form of declaration testimony and prior art references, to support its position that a skilled artisan would reasonably have expected that replacing hydrogen with deuterium at C20 of a retinoid in the A2E biosynthetic pathway will retard the accumulation of A2E,” which is part of Petitioner’s stated reason for combining the asserted references.

In particular, although we agree with the general proposition that motivation and expectation of success are separate requirements of obviousness, see, e.g., Eli Lilly & Co. v. Teva Pharms Int’l GmbH, 8 F.4th 1331, 1344 (Fed. Cir. 2021), in this case they are intertwined.

In that case, the district court found, and the Federal Circuit agreed, that “on a purely mechanical level,” an ordinarily skilled artisan would have had a reasonable expectation of success of manufacturing the claimed extended release formulation once motivated to use the recited active ingredient.

Addressing this argument, the Federal Circuit determined that “[t]he issues ... reduce essentially to whether one of ordinary skill in the art ... would have had a reasonable expectation that [the recited active ingredient] would be colonically absorbed and therefore would have been motivated to produce the claimed extended release formulation.” Id. at 1293–1294 (emphasis added).

The Federal Circuit found no clear error in the district court’s factual findings that the evidence sufficiently showed an ordinarily skilled artisan “would ... have perceived a reasonable likelihood of success and ... been motivated to combine prior art to make the claimed invention.” Id. at 1295.

In stipulating to move any due dates in the scheduling order, the parties must be cognizant that the Board requires four weeks after the filing of an opposition to the motion to amend (or the due date for the opposition, if none is filed) for ...

Petitioner further contends that that POSA “may have worked in consultation with a team including, e.g., a practicing physician who diagnoses and treats macular degeneration” and would have had “practical knowledge about biological studies, pharmaceutical formulation, and the deuterium isotope effect.” Id. (citing Ex. 1002 ¶¶ 47–50; Ex. 1004 ¶¶ 38–40).

Specifically, Petitioner argues that a POSA would have understood by September 2007 that making use of Bergen’s deuterated compounds for biological studies would have involved formulation in a pharmaceutically acceptable carrier, as corroborated by Furr’s success in doing so.

Accordingly, at this stage of the proceeding, having considered the arguments and evidence set forth in the Petition, we find Petitioner has shown a reasonable likelihood of prevailing on its assertion that Claims 1–4 would have been obvious in light of the combination of Bergen and Furr.

For example, regarding claim 7, Petitioner asserts that Widder teaches a pharmaceutical composition comprising an effective amount of fenretinide co-administered with vitamin A to inhibit the development or reoccurrence of macular degeneration.

At this stage of the proceeding, having considered Petitioner’s arguments and evidence, we are persuaded that Petitioner has shown sufficiently that a POSA would have combined Widder’s composition with Ortho Pharma and Bergen to reach the invention of claims 7, 24, and 26 with a reasonable expectation of success.

59 IPR2024-00313 Patent RE47,045 Finally, Patent Owner argues that “none of the art or arguments advanced by the Petition would have affected the outcome.” Prelim. Resp. 63.

In stipulating to move any due dates in the scheduling order, the parties must be cognizant that the Board requires four weeks after the filing of an opposition to the motion to amend (or the due date for the opposition, if none is filed) for ...