Elekta Limited v. ZAP Surgical Systems, Inc.
Docket No. 2021-1985 (IPR2019-01659) (https://cafc.uscourts.gov/opinions-orders/21-1985.OPINION.9-21-2023_2193832.pdf)
REYNA, STOLL, STARK
September 21, 2023
Brief Summary: Board IPR decision finding Elekta’s claims unpatentable for obviousness affirmed. Summary: Elekta appealed Board IPR final written decision finding US 7,295,648 directed to a device for treating a patient with ionizing radiation unpatentable as obvious. ZAP alleged obviousness in view of several references, three of which are considered in this decision (a first US patent (“Grady”) disclosing an X-ray tube, a publication (“Ruchala) disclosing a CT-type scanner, and a second US patent (“Winter”) disclosing a combination of a CT scanner using radiant energy for imaging “for therapeutically irradiating a target”)). The Board “considered whether a skilled artisan would have been dissuaded from combining the devices because one device was an imaging device, rather than a radiation device, and because the [CT-type scanner’s] weight would render the Grady device inoperable, imprecise, and unsuitable for treatment”, and “concluded that a skilled artisan would have been motivated to combine Grady and Ruchala.” Elekta argued “that the Board’s findings on a motivation to combine are unsupported by substantial evidence”, “that the Board failed to make any findings, explicit or implicit, on a reasonable expectation of success”, “and that even had the Board made such findings, those findings are not supported by substantial evidence”. The FC panel explained that “an obviousness determination does not always require prior art to expressly state a motivation for every obvious combination” or “that a particular combination must be the preferred, or the most desirable, combination described in the prior art in order to provide motivation for the current invention” (OSI, FC 2019; Fleming, FC 2022; Novaris, FC 2019). It also agreed with “the Board’s finding that a skilled artisan would have been motivated to combine the Grady device with Ruchala’s [CT-type scanner] is supported by substantial evidence, including the prosecution history of the ’648 patent, the teachings of the asserted prior art references, and the expert testimony of record.” Elekta also argued “that the Board erred as a matter of law because it failed to articulate any findings on reasonable expectation of success”. The FC panel explained that “[u]nlike a motivation to combine determination, which requires an explicit analysis, …a finding of reasonable expectation of success can be implicit” (KSR, US 2007; Merck & Cie, FC 2015; Packard, FC 2000 (not in tension with requiring “Board to “explain its decisions with sufficient precision, including the underlying factfindings and [its] rationale” under APA); In re NuVasive, FC 2016 (“can ‘reasonably discern’ an implicit finding by the Board on reasonable expectation of success”)). In this decision, the FC panel explained that it “can reasonably discern that the Board considered and implicitly addressed reasonable expectation of success based on the arguments and evidence presented to the Board on motivation to combine” (Merck & Cie, FC 2015). Regarding the reasonable expectation of success, the FC panel explained, that “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 “need not lead to a single conclusion to support a finding of substantial evidence” (Velander, FC 2003). And it concluded the Board correctly concluded the skilled artisan would have had a reasonable expectation of success. The FC panel also rejected Elekta’s argument that ZAP was subject to a “clear and convincing” standard because for an IPR the petioner’s burden is a preponderance of the evidence (35 USC 316(e)). The Board decision was therefore affirmed.