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IPR2015-00291 decided a petition filed by Daiichi Sankyo Co. against USPN 8,168,181 owned by Alethia Biotherapeutics, Inc. The decision illustrates the potential of intervening art not considered during prosecution and also illustrates the shifting legal view of the patentability of antibody-based technologies.

The ‘181 patent issued from a continuation-in-part of the U. national phase of a PCT application and contains claims drawn to methods of impairing osteoclast differentiation, useful in treating various bone diseases. Bone metabolism involves a balance between new bone growth mediated by osteoblast cells and bone resorption or loss mediated by osteoclast cells.

Intervening between the PCT filing date and the CIP filing date was a PCT publication of Hiruma that led to USPN 8,546,540.

In response to Petitioner’s assertion that Hiruma anticipated the claims of the ‘181 patent, the Patent Owner conceded that Hiruma, if properly available against the claims, did destroy their novelty. Petitioner and Patent Owner argued the enablement issue, with Petitioner citing the factors and arguing that undue experimentation would have been required to identify a specific anti-Siglec-15 antibody that exhibited the function of inhibiting Siglec-15’s effect on osteoclast differentiation and bone loss.

Both Petitioner and Patent Owner relied on witnesses to establish or deny prior conception and reasonable diligence by Patent Owner from a time prior to publication of Hiruma until constructive reduction to practice by filing the CIP application.

A PCT application was filed that disclosed this information and described general techniques for generating and testing antibodies specifically binding and inhibiting Siglec-15.

Subsequently, the CIP application maturing into the ‘181 patent was filed that added disclosure of the actual generation of specific anti-Siglec-15 antibodies.

The Patent Owner argued that Hiruma was not available as prior art because, first, a priority claim established an effective filing date for the challenged claims that was earlier than publication of Hiruma and, second, that even if Hiruma were available against the claims, Patent Owner could antedate Hiruma. The Board agreed that the priority PCT application provided no guidance or exemplification of functional anti-Siglec-15 antibodies.

Petitioner challenged entitlement to the priority date claimed in the ‘181 patent, asserting that the priority PCT application didn’t disclose the claimed invention in a manner that satisfied 35 U. Petitioner also argued lack of adequate written description to support the issued claims and Patent Owner relied on the “whole antigen characterization” theory of , asserting that Siglec-15, the antigen, was fully characterized in the priority PCT application and this should suffice to provide written description for a specific anti-Siglec-15 antibody having a known general antibody structure.

As a consequence, the priority claim fell and Hiruma became § 102(a) art against the ‘181 claims.

The Board then turned to Patent Owner’s second argument based on antedating the Hiruma reference.

The Board noted that the law had progressed through a series of court decisions beyond .

Search for antedating a reference:

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The Board concluded that the issued claims failed to satisfy the written description requirement.

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