Ethicon LLC v. Intuitive Surgical, Inc.
Docket No. 2021-1995, -1997 (IPR2020-00050, -00051) (https://cafc.uscourts.gov/opinions-orders/21-1995.OPINION.5-23-2022_1955050.pdf) (Non-precedential)
NEWMAN (D), REYNA, HUGHES
May 23, 2022
Brief Summary: Board IPR finding of invalidity for obviousness affirmed.
Summary: Ethicon appealed USPTO Board IPR final written decision (FWD) holding the challenged claims of US 9,844,379 B2 directed to surgical stapling instruments invalid for obviousness. Ethicon argued the Board erred in placing the burden of proof on it, the patent owner, and that the Board’s finding of a reasonable expectation of success in combining the prior art (the Green and Solyntjes US patents) is not supported by substantial evidence. This opinion explains that “Green accounts for the majority of the claimed features in the ’379 Patent” and Solyntjes discloses a surgical stapler with a locking pin, as claimed in the ‘379 patent. Ethicon conceded that the two references together “disclose all the elements claimed by the challenged claims” but argued that one of ordinary skill in the art would not have been motivated to make the combination (not addressed here as it conceded the issue at oral argument) or had a reasonable expectation of success in making the combination. Ethicon’s expert testified that the skilled artisan “would be incapable of” modifying Green with Solyntjes but the Board discredited that testimony as “based on little evidentiary support in the record” and “largely premised on…speculation” about “insurmountable” difficulties in doing so. The Board found the testimony of Intuitive’s expert “logical and credible” and that a skilled artisan “would be able to ‘account for routine considerations, e.g., location, positioning, and robustness of a locking mechanism, as a part of Green’s instrument.’” The Board therefore found obviousness was established by a preponderance of the evidence. The FC panel considered the Board’s decision de novo for substantial evidence as whether there was a motivation to combine and a reasonable expectation of success are questions of fact (Randall, FC 2013; Graham, US 1966; Par, FC 2014; Alza, FC 2006). The FC panel explained that “[t]he fact that the petitioner bears the burden of proof in a Board proceeding does not eliminate the patent owner’s burden to proffer opposing evidence against the petitioner’s showing of unpatentability” (Novo, FC 2013; Bos. Sci., FC 2020 (“that the Board addresses the patentee’s counterarguments is not an improper shifting of burdens”)). Here, the FC panel explained, the Board properly “weighed competing evidence and made its determination on the record as a whole”. The FC panel also explained that “[e]vidence of a reasonable expectation of success, just like evidence of a motivation to combine, ‘may flow from the prior art references themselves, the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved’” (Brown & Williamson, FC 2000). And it found the Board’s conclusion based on expert testimony (e.g., “routine considerations”) to be supported by substantial evidence. Judge Newman’s dissent argued that “[t]he court reconstructs a novel surgical device from components of known devices, using the ’379 patent as a template for the reconstruction” (KSR, US 2007 (in which “[s]uch judicial hindsight was negated”)).