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Axonics v. Medtronic
Friday, December 15, 2023

The Federal Circuit vacated and remanded two Patent Trial and Appeal Board (“PTAB”) decisions because the PTAB erred in its obviousness analysis and found that Axonics failed to show a motivation to combine as to Medtronic’s ‘314 and ‘756 patents.

Background

Medtronic sued Axonics for patent infringement. Medtronic’s invention concerns a medical device that stimulates sacral nerves. Axonics filed two inter partes review (IPR) petitions to challenge various claims of the U.S. Patent Nos. 8,626,314 and 8,036,756 (“the Medtronic Patents”) for obviousness under 35 U.S.C. §§ 311-319. No claim of the Medtronic Patents is limited to sacral nerves. Axonics argued that the Medtronic Patents were invalid based on preexisting patents and other publications that disclosed the same technology, particularly Young and Gerber. Both of Axonics’ petitions relied on the same combination of Young and Gerber.

The PTAB ruled for Medtronic, finding that Axonics failed to show a motivation to combine. It concluded that Axonics failed to show that a relevant artisan would have a motivation to combine the teachings of Young and Gerber because the proposed combination “would not be feasible in the trigeminal nerve region.” The Board reached that finding by defining the relevant art as limited to medical leads for sacral-nerve stimulation. Axonics appealed under 35 U.S.C. § 142 and 37 C.F.R. § 90.3(a)(1).

Issues

(1) Did the PTAB err in confining its motivation-to-combine inquiry to what would work in the trigeminal nerve context?; and (2) Did the PTAB err in limiting its definition of the relevant art to medical leads specifically for sacral neuromodulation?

Holding(s)

The Federal Circuit vacated and remanded the PTAB’s decisions finding that: (1) the PTAB adopted a legally incorrect framing of the motivation-to-combine inquiry when it confined the inquiry to whether a motivation would exist to make the Gerber-Young combination for use in the Young-specific trigeminal-nerve context; and (2) the PTAB erred in its definition of the relevant art as being limited to medical leads for sacral-nerve stimulation.

Reasoning

First, the Board committed a fundamental error in confining the motivation inquiry to whether a motivation would exist to make the proposed combination for use in the Young-specific trigeminal-nerve context because the Medtronic Patents are not limited to that context. The “real question” is “why a person of ordinary skill in the art would have combined elements from specific references in the way the claimed invention does.” Second, the PTAB was incorrect in limiting the definition of “the relevant art” to medical leads for sacral-nerve stimulation because the Medtronic patent claims are not so limited. In fact, they make no reference to sacral neuromodulation.

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