Axonics, Inc. v. Medtronic, Inc.
Docket No. 2022-1451, -1452 (IPR2020-00715, -00679) (https://cafc.uscourts.gov/opinions-orders/22-1451.OPINION.7-10-2023_2154482.pdf)
LOURIE, DYK, TARANTO
July 10, 2023
Brief Summary: Board IPR decision finding Axonics did not show Medtronic’s patents to be obvious reverses as based on incorrect narrowing of the prior art.
Summary: Axonics timely appealed IPR final written decisions in which the Board found it had not shown Medtronic’s claims (of US 8,626,314 and 8,036,756) directed to implantable nerve stimulation systems obvious. The claims include “features key to the present appeal: at least two electrodes at the distal end of the lead, with ‘a plurality M of tine elements arrayed . . . along a segment of the lead proximal to the stimulation electrode array’” (figure provided in this opinion). Axionics alleged obviousness over Young (a non-patent publication) in view of Gerber (a US patent) and Lindegren (a published PCT application), arguing that “a relevant artisan would have been motivated ‘to replace the one electrode of Young with multiple electrodes at the distal end distal to the anchoring mechanism, as taught in Gerber, in order to provide more flexibility in activation of a wider area and provide the possibility for bipolar electrical stimulation, as taught in Young.’” Axionics argued “that Young and Gerber ‘reasonably address[] the similar problems of leads adequately stimulating the nerves while limiting electrode migration”—a problem that Axonics contended [Medtronic’s] patent also addresses’” and are “‘from the same field’: ‘neurostimulation with implantable medical leads with electrode(s) at the distal end of the lead and a proximal anchoring mechanism’” (citing Tokai, FC 2011). “Axonics also argued that Young expressly provides a motivation to make the asserted combination when it states that the neurostimulator used in the clinical study “could be improved to provide multiple active stimulation sites near the tip” and “that, at the priority date, there were a “limited number of devices available . . . to anchor by fibrosis,” tines being the predominant one.” The Board disagreed with Axonics, acknowledging “that it had ‘demonstrated each limitation of independent claim 1 in its proposed combination” but finding it relied “on the ‘field of the invention’ statements to narrow the field in that way even though the claims are not limited to sacral nerves”. The Board found that “Axonics, Young, Gerber, and the [Medtronics] patent do not solve the same problem” (“implanted, percutaneously placed electrode system for . . . stimulation of the trigeminal sensory root” and “positioning and securement of an electrode that is implanted in the sacral area via a non-percutaneous surgical procedure”, respectively) and there would not have been a motivation to combine the references. The FC panel review the Board’s obviousness decision de novo as it is a question of law based on factual findings such as the prior art, the level of skill in the field, and the motivation to combine references, citing Henny Penny (FC 2019) and PAR Pharm. (FC 2014). It found the Board erred in confining the motivation inquiry to the trigeminal nerve context, which “is not part of the Medtronic patents’ claims” (and “the only reasonable reading of the specification is contrary to the Board’s narrow definition”), and incorrectly viewed the relevant art as limited to medical leads for sacral neuromodulation, despite the claims not being so limited (Sanofi, FC 2023 (“what constitutes ‘analogous art’ for section 103 purposes is tied to ‘the claimed invention’”). These errors were not considered harmless, leading to the vacating of the Board’s decisions and a remand for further proceedings.