In re: NuVasive, Inc.

Docket No. 2015-1670 (IPR2013-00506)

December 7, 2016

Brief Summary: PTAB IPR decision vacated and remanded as it failed to provide an adequate explanation of the motivation to combine the cited references.

Summary: NuVasive appealed final written decision finding claims 1-14, 19-20 and 23-27 of its US 8,361,156 relating to “spinal fusion implant[s]” invalid as obvious over four prior art documents (“SVS-PR brochure”, “Telamon brochure”, “Telamon guide” and “Baccelli” (US 2003/0028249)). The FC panel opinion explains that the PTAB’s factual determinations are reviewed for substantial evidence (i.e., “more than a mere scintilla of evidence” (In re Kotzab, FC 2000), “evidence as a reasonable mind might accept as adequate to support a conclusion” (In re Appld. Mat., FC 2012)) and its legal determinations de novo (In re Gartside, FC 2000). The FC panel first considered “whether NuVasive preserved its public accessibility arguments for appeal” and concluded it did not because it “failed to challenge public accessibility during the trial phase”, even “explicitly declin[ing] to make further arguments”, “even through the PTAB had warned NuVasive [its position] would result in waiver.” It then considered “whether the PTAB adequately set forth findings and explanations to support the conclusion” of obviousness of sole independent claim 1. It explained that although it reviews factual findings regarding motivation for substantial evidence, “‘[t]he factual inquiry whether to combine references must be thorough and searching,’ and ‘[t]he need for specificity pervades [our] authority’ on the PTAB’s findings on motivation to combine” (In re Lee, FC 2002). The FC panel agreed with NuVasive that the PTAB “relied on one conclusory statement by Medtronic’s expert that the modification would provide ‘additional information’” and that this was not sufficient. The opinion states that “[f]irst, the PTAB must make the necessary findings and have an adequate ‘evidentiary basis for its findings’” and “must examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made” (Motor Veh. Mfrs. Assn., US 1983; Synopsys, FC 2016 (“the PTAB ‘must articulate logical and rational reasons for [its] decisions”)). It is that explanation that “enables the court to exercise its duty to review the PTAB’s decisions to assess whether those decisions are ‘arbitrary, capricious, an abuse of discretion, or…unsupported by substantial evidence” (5 USC § 706(2)(A)-(E) (2012; Dickinson v. Zurko, US 1999). It noted that it does “not require perfect explanations” and “may affirm the PTAB’s findings ‘if [it can] reasonably discern that it followed a proper path, even if that path is less than perfectly clear’” (Ariosa, FC 2015; Bowman Transp., US 1974). Thus, it explained “the PTAB must articulate a reason why (italicized) a PHOSITA would combine the prior art references” (citing Nike, FC 2016; Allied Erecting, FC 2016; Cutsforth, FC 2016) and “cannot rely solely on common knowledge or common sense to support its findings” (Arendi S.A.R.L., FC 2016; In re Rouffet, FC 1998). Here, it found the PTAB failed to provide an adequate explanation of the motivation to combine the cited references, and therefore vacated and remanded the decision.

This entry was posted in Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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