Axonics Inc. v. Medtronic Inc.
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New Claim Construction in Patent Owner’s Post-Initiation IPR Response? Sure, Charge Away

Addressing the issue of new claim constructions presented by a patent owner after the institution of inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit found that a petitioner is entitled to argue and present evidence under the new construction so long as it relies on the same prior art embodiments used in the petition. Axonics, Inc. v. Medtronic, Inc., Case No. 22-1532 (Fed. Cir. Aug. 7, 2023) (Dyk, Lourie, and Taranto, JJ.)

Medtronic owns two patents directed to the transcutaneous charging of implanted medical devices via inductive coupling between a primary coil in an external charger and a secondary coil in the implanted device. The relevant claims of each patent require the external charger’s power to be automatically varied based on “a value associated with the current passing through the internal power source” (the value limitation) and “a measured current associated with the current passing through the internal power source” (the measured current limitation).

Axonics filed two IPR petitions challenging Medtronic’s patents, arguing that the claims were anticipated by three prior art references. Axonics’s petitions did not propose any express claim constructions, but its claim charts stated that the measured current limitation simply narrows the “value” in the value limitation to “measured current” and does not require a separate measurement. Under this “one-input” construction, both limitations would be satisfied if the external power source automatically varied its power output based on the implanted device’s current. In its preliminary response, Medtronic agreed that while claim construction was not necessary, the prior art failed to anticipate the claimed device under the one-input construction. In its institutional decision, the Patent Trial & Appeal Board agreed that “no term requires express construction.”

In its patent owner response, Medtronic (for the first time) advanced a new claim construction, arguing that the value limitation and the measured current limitation required separate inputs (the two-input construction). In Axonics’ reply, it defended the one-input construction and further argued that the three prior art references also disclosed the claimed device under the two-input construction. In support of its reply, Axonics submitted a supplemental expert declaration citing additional disclosures in the prior art references pertaining to the same embodiments relied upon in the petition. Medtronic argued that it would be prejudicial for the Board to consider Axonics’ new reply arguments without providing Medtronic an opportunity to submit a supplemental expert declaration. Medtronic, however, did not seek leave to submit a new declaration.

In its final written decision, the Board adopted the two-input construction and declined to consider Axonics’ arguments and evidence under the new construction, considering them to be improper reply arguments. Axonics appealed.

The Federal Circuit acknowledged that a petition is required to identify “in writing and with particularity…the grounds on which the challenge to each claim is based, and the evidence that supports the grounds.” To that end, a petitioner may not submit new evidence or arguments in a reply that could have been raised earlier but may respond to new arguments [...]

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Hit a Nerve? Obviousness Inquiry Must Address Claims at Issue

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board non-obviousness decision, finding that the context of the proposed combination of prior art in the Board’s obviousness inquiry was not directed toward the context of the claim at issue. Axonics, Inc. v. Medtronic, Inc., Case No. 21-1451 (Fed Cir. July 10, 2023) (Lourie, Dyk, Taranto, JJ.)

Axonics filed petitions for inter partes review (IPR) challenging the validity of two patents owned by Medtronic as obvious. During the IPRs, the Board analyzed two prior art references, an article titled, “Electrical Stimulation of the Trigeminal Nerve Root for the Treatment of Chronic Facial Pain” by Ronald Young and a patent assigned to Gerber. The Medtronic patents described percutaneously positioning a lead to stimulate the sacral nerve. By contrast, Gerber described positioning an electrode in the sacral nerve region in a non-percutaneous way, and Young described positioning an electrode percutaneously to stimulate the trigeminal sensory root. The Board found that Medtronic’s patents were not obvious over Young in view of Gerber because of lack of motivation to combine the two prior art references. The Board also noted “that the proposed combination ‘would not be feasible in the trigeminal nerve region.’” Axonics appealed.

The Federal Circuit found that the Board erred in conducting the obviousness analysis. The Board’s proposed analysis centered on Young’s trigeminal sensory root context, not the Medtronic patents’ sacral nerve context. First, the Board questioned whether motivation to use the resulting combination of Young and Gerber existed in the trigeminal nerve context, but not in Medtronic patents’ sacral nerve context. Second, the Board found “that the relevant art [of the Medtronic patents] is medical leads specifically for sacral neuromodulation.”

Addressing the first error, the Federal Circuit explained that the prior art combination must be directed toward meeting the requirement of the claimed patent, not the requirement of the first prior art. The Court found that the Board did not conduct this analysis. Addressing the second error, the Court noted that “the relevant art” of the Medtronic patents was not “limited to medical leads for sacral-nerve stimulation.” The Court examined the specification of the patent as well as its claim and ruled that the scope of the Medtronic patents was broader than what the Board concluded.

The Court found that the Board’s errors were not harmless since the Board relied on these errors in rejecting Axonics’s obviousness arguments and provided no other reason for concluding Medtronic’s claims were not obvious. Therefore, the Court vacated the Board’s decision and remanded for further consideration.

Practice Note: In considering obviousness arguments under 35 U.S.C. § 103, keep in mind the difference between the claim at issue and the considered combination of prior art. The scope of the claim also needs to be considered based on the entirety of the patent.

Woohyeong Cho, a summer associate in the Washington, DC, office, also contributed to this case note.

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