In Re: Qapsule Technologies, Inc.

Docket No. 2018-1772

March 11, 2019

Brief summary: Board decision of anticipation based on inherent disclosure affirmed.

Summary: Qapsule appealed PTAB (“Board”) decision finding certain claims of its application directed to a synthetic pharmaceutical capsule anticipated by the prior art. Representative claim 1 includes “a shell having a plurality of shell proteins” forming an enclosure as well a “non-naturally occurring” “bifunctional polynucleotides” linking a “cargo protein” to “said enclosure”. The FC panel opinion explains that, in a new ground of rejection, “[t]he Board found that Perez discloses a recombinant influenza A virus and relied upon Mair as evidence of the inherent structural features of such a virus”, “that the ‘M1’ protein met the claim 1 limitation of ‘shell protein,’ that the mutated ‘PB1’ protein of Perez met the limitation of a recombinant ‘cargo protein,’ and the mutated viral RNA of the ‘RNPs’ constituted” a “non-naturally occurring” “bifunctional polynucleotide…capable of binding both the M1 shell protein and the PB1 protein” (as evidenced by Ye and Gonzalez). The FC panel also explains that “[f]aced with the new ground of rejection, Qapsule has the option of reopening prosecution before the examiner” but instead “requested rehearing” in front of the Board. Qapsule argued the prior art did not show recombinant shell proteins but “[t]he Board determined that Qapsule’s reliance on the term” was an improper “attempt to impose a method step into a claim for a product” (In re Dilnot, CCPA 1962 (“addition of a method step in a product claim, which product is not patentably distinguishable from the prior art, cannot impart patentability to the old product”); Ex Parte Finn, PTAB Feb. 1, 2018). In this appeal, Qapsule argued “that Perez does not inherently disclose the ‘bifunctional polynucleotide’ claim limitation” and that “there are structural differences between” Perez and the claimed shell proteins and bifunctional polynucleotide. The FC panel reviewed “the Board’s factual finding of inherent anticipation for support by substantial evidence” (“more than a scintilla of evidence”, “as a reasonable mind might accept as adequate” (In re Kotzab, FC 2000; Consol. Edison, US 1938)). It first disagreed with the PTO’s argument that Qapsule waived arguments regarding the bifunctional polynucleotide, finding the argument to have been “sufficiently developed in the record before us” (Harris, FC 2005). Qapsule’s argument that the “viral assembly in Ye occurs in the presence of ribonucleoprotein” which is not claimed was rejected by the FC panel because “the present claims use the open-ended term ‘comprising,’ and do not exclude capsule assembly in the presence of ribonucleoprotein” (same conclusion here regarding “having”, although it “does not create a presumption that the body of the claim is open” (Crystal, FC 2001)). The FC panel also found that “the Board properly applied the concept of inherency on an element-by-element basis” (In re Best, CCPA 1977 (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of the claimed product.”)) The FC panel also explained that “[u]nclaimed limitations cannot distinguish the claims” (Ventana, FC 2006), and affirmed the Board’s decision.

This entry was posted in Anticipation (35 USC 102), Inherency. Bookmark the permalink.

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