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In re NuVasive, Inc. - Explain Yourself!

In re NuVasive Emphasizes the Importance of Reasoning in the Obviousness Question.

Business Man Holding Contract Agreement Vector Illustration Signed Treaty PaperSince KSR, 127 S.Ct. 1727 (2007), repudiated as “rigid and mandatory” the Federal Circuit “rule” for obviousness –  that the prior art must provide a teaching, suggestion or motivation (TSM) to combine references so as to arrive at the claimed invention. Since then, it is my opinion that reliance on secondary considerations to support obviousness determinations has steadily increased. Such considerations include unexpected results, long-felt need, failure of others, teachings away from the invention, commercial success and the like. Likewise, Examiners have increased their reliance on factors such as common sense and routine optimization.

However, In re NuVasive, the Fed. Cir. vacated a finding of obviousness by the PTAB on the basis that the Board had not adequately set forth its reasoning for ruling that a spinal fusion implant comprising radiopaque markers was obvious in view of the cited art.

KSR is notable for not emphasizing this requirement in any detail, at least when compared to the lengthy analyses the Court applied to explicate the flaws in the TSA test, concluding that “rigid preventative rules that deny factfinders recourse to common sense, however, are neither necessary  under our case law not consistent with it.”

However, unlike the simple KSR device, the Court wrote that, “it will often be necessary to look to interrelated teachings of  multiple  patents; the effects of demands…present in the marketplace; and to the background knowledge possessed by [POSA]…. To determine whether there was an apparent reason to combine the known elements in the fashion claimed the patent at issue. To facilitate review, this analysis should be made explicit. [Citing In re Kahn with approval as requiring articulated reasoning to support a conclusion of obviousness.]…it can be important to identify a reason that would have prompted a [POSA]…to combine the elements in the way the claimed new invention does.” 127 S. Ct. at 1740-41.

In re NuVasive, NuVasive argued that, in making its final decision, the PTAB relied on only one conclusory statement by Medtronic’s expert that the modification would provide “additional information” to the surgeon. The Fed. Cir. relied on Synopsys v. Mentor Graphics, as stating that, “as an administrative agency, the PTAB ‘must articulate logical and rational reasons for [its] decisions” so that the court can review the decisions to determine if they are unsupported by substantial evidence. “The PTAB must articulate a reason why a [POSA] would combine the prior art references.”

Insufficient articulations of motivation to combine include “conclusory statements” alone, not explaining why the PTAB accepts one argument over another, relying solely on common sense or common knowledge or invoking a high level of skill in the art, without more. In re Nuvasive, the Fed. Cir. found all of these instead of the reasoned analysis that KSR requires to support “motivation to combine.” The PTAB’s decision was vacated and remanded for further findings and explanations.

Practitioners, this decision should be added to your kits of tools to rebut obviousness findings. In KSR, the Court provided most of the requirement to explain language in dictum, to the extent that it was discussing the standards applicable to inventions involving components much more complex than the KSR brake assembly, but the Court cited relevant case law with approval.

Read In re: NuVasive, Inc.

Read more on KSR.


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