The General Hospital Corporation v. Sienna Biopharmaceuticals, Inc.

Docket No. 2017-1012

May 4, 2018

Brief summary: PTAB claim construction affirmed but denial of GHC’s motion to introduce a new claim vacated and remanded.

Summary: GHC appealed PTAB dismissal of an interference (with Sienna’s US 8,821,941) after determining that it lacked standing because the claims of U.S. Ser. No. 13/789,575 relating to “methods of removing hair using nanoparticles to damage hair follicles” lacked written description under § 112, and its denial of GHC’s contingent motion to add a new claim. Disputed ‘575 claim 65 is directed to a method using “unassembled plasmonic particles” with “a concentration of about 6.6×10[11] particles per ml of the composition”, with “about” being construed to mean “within 10%”. Sienna argued for unpatentability because the ‘575 “disclosure…describes formulations by reference to optical density (OD) rather than particles per ml”. Accepting Sienna’s expert’s testimony that “an extinction coefficient of 4.2” should be used to convert “optical density to concentration in particles per ml”, the PTAB construed claim 65 as “encompass[ing]…a range of at most from 5.94×10[11] to 7.26×10[11] particles per ml” and found a lack of written description thereof. GHC moved to add new claim 74 limiting the nanoparticles to a particular optical density, but the PTAB denied its motion because, e.g., “GHC…failed to provide supporting evidence that this claim was patentable.” The FC panel reviewed the WD decision for substantial evidence (Inphi, FC 2015; Perfect Surgical, FC 2016), the question being “whether the disclosure…reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” (Ariad, FC 2010 (en banc)). The FC panel found that the PTAB properly construed “about” and the corresponding claimed range (e.g., neither the intrinsic or extrinsic evidence support GHC’s construction of +/-20% and GHC did not present an alternative construction). Based on this definition, the FC panel also found that “substantial evidence supports the Board’s findings that none of the disclosed values within the ‘575 application fall within 10% of the claimed value” (Purdue, FC 2000 (“where a specification discloses a broad range…the disclosure must allow one skilled in the art to ‘immediately discern the limitation at issue in the claims’…one cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention.”); “a disclosed range that minimally overlaps with the claimed range does not provide written description support for the claimed range” (Eiselstein, FC 1995 (“the range of ‘about 45-55%…is not the same as a very different range, viz., 50-60%’”)). The FC panel also reviewed the PTAB’s denial of GHC’s motion to amend “to determine if it is arbitrary or capricious” (Veritas, FC 2016), finding that it was because GHC complied with the PTAB’s Standing Order requiring GHC “to ‘certify’ that it was not aware of any reason why the claim was not patentable” and GHC “put forth sufficient evidence to establish proposed claim 74 would have been rendered obvious by claim 1 of the ‘941 patent” (Galderma, FC 2013; Alcon, FC 2012; In re Peterson, FC 2003; In re Baird, FC 1994; Genetics Inst., FC 2011 (all relating to the obviousness of ranges)). Thus, the PTAB’s denial of GHC’s motion to add a new claim was vacated and remanded.

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