IPR2018-00919 (US Pat. No. 8,008,001 B2)
Decision denying institution (October 12, 2018)
Brief summary: Merial’s request for IPR denied because “the same or substantially the same prior art or arguments” were presented during prosecution of IV’s ‘001 patent.
Summary: Merial requested IPR of IV’s US ‘001 patent directed to “[a] method for the protection of piglets that are Porcine circovirus type 2 (PCV-2) maternally derived antibody (MDA) positive against PCV-2 infection, comprising administering a vaccine comprising at leat 20 micrograms/dose of ORF-2 protein of PCV-2.” Merial alleged 12 different ground for obviousness against subsets of ‘001 claims 1-8. The person of skill in the art was determined to be a veterinarian (DVM) or equivalent, as proposed by Merial. The Board interpreted the claims “using the ‘broadest reasonable construction [BRC] in light of the specification of the patent” (§ 42.100(b); Cuozzo, US 2016; Trivascular, FC 2016; note, however, that the PTO recently issued a memorandum explaining that as of Nov. 13, 2018 the BRC will be replaced by the Phillips (FC 2005) standard). Merial, also relying on an expert declaration, argued that the various references disclose the claimed method and the claims therefore would have been obvious (e.g., “an ordinarily skilled artisan would have understood the vaccines disclosed…to have at least 20 micrograms of antigen”). IV argued the Board should “deny institution because Petitioner fails to raise ‘a single argument that [was not] considered and overcome during prosecution.” The Board explained that it has discretion to deny institution “when ‘the same or substantially the same prior art or arguments previously were presented to the Office’” under § 325(d) (Becton, Dickinson, IPR2017-01586 (non-exclusive factors are weighed, e.g., “similarities and material differences”, “cumulative nature of the asserted art”, “the extent to which the asserted art was evalulated during examination”, “the extent of the overlap between the arguments”, “whether Petition has pointed out sufficiently how the Examiner erred”, “the extent to which additional evidence and facts…warrant reconsideration”)). The Board found that “the Examiner considered many of the same prior art references” during prosecution; the “Meng” reference, while not included in a rejection during prosecution was “listed as one of only 10 references on the front cover of the patent”, “is cumulative to the prior art the Examiner previously evaluated during prosecution” (similar conclusion reached as the “Van Woensel” reference); “that the Examiner evaluated Jestin, Blanchard” (the references about which Meng was found to be cumulative) “and the cumulative reference Van Woensel during examination…and substantively applied their teachings to reject the claims”; Merial’s “analysis here is substantially the same as the Examiner’s during prosecution”; Merial “fails to point out whether or how the Examiner erred in evaluating the asserted prior art”; and Merial did not explain and it did not find that its expert testimony “is a sufficient reason” for reconsideration of “the same or substantially the same prior art that the Examiner considered”. Thus, the Board concluded “that the factors weigh in favor of exercising [its] discretion” and denied institution.