Patent Owner Finds Success: Petitioner's Argument Had Too Much Picking And Choosing, Conclusory Statements, And Failed To Overcome Strong Evidence Of Unexpected Results

• Published date: 29 June 2023
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Ms Amanda Murphy, Umber Aggarwal and Stacy Lewis

In Transgene v. Replimune Ltd., PGR2022-00014, Paper 38 (P.T.A.B. May 25, 2023), Transgene challenged claims 1-8 and 10-26 of Replimune's U.S. Patent No. 10,947,513 ("the '513 patent"). Replimune filed a statutory disclaimer of claims 1-8, 10-12, and 14-26 as part of its Patent Owner Preliminary Response.

Claim 13, the only remaining claim in the proceeding, depended on claims 1 and 11, each of which is reproduced below.

1. An oncolytic virus comprising:

(i) a heterologous GM-CSF-encoding gene; and

(ii) a heterologous CTLA-4 inhibitor encoding gene, wherein both heterologous genes are inserted into the genome of the virus.

11. The virus of claim 1, which is a herpes simplex virus (HSV).

13. The virus of claim 11, wherein the GM-CSF-encoding gene and the CTLA-4 inhibitor encoding gene are inserted into the ICP34.5 encoding locus, either by insertion, or partial or complete deletion, in a back to back orientation in relation to each other, each under separate regulatory control.

Anticipation

The Board first addressed the merits of the challenge to claim 11, despite the statutory disclaimer, and was not persuaded that claim 11 was anticipated. Silvestre, the asserted reference, did "not disclose a single embodiment of an oncolytic HSV that includes both a heterologous GM-CSF encoding gene and a heterologous CTLA-4 inhibitor encoding gene." Id. at *19. Instead, Transgene attempted to "randomly" select from "broader lists of possible oncolytic virus classes, immune checkpoint targets, and therapeutic genes," but the Board found this tactic involved too much "picking and choosing" and undermined Transgene's anticipation ground. And although the Board ultimately concluded that Transgene was too late in raising the argument that one skilled in the art could "immediately envisage" the HSV of claim 11, the Board nevertheless commented that Transgene's argument was not persuasive because it required reading too much into statements about preferred embodiments in the specification and was still based on too much "picking and choosing" from different portions of the reference. Id. at *21-23.

Since challenged claim 13 depended from claim 11, the Board considered its anticipation analysis sufficient for claim 13. Id.at *19.

Obviousness

The Board also found Transgene did not carry its burden with respect to proving claim 13 obvious because Transgene's motivation to combine arguments were unconvincing.

First, the Board addressed Transgene's expert's testimony that the...