Motivation to Combine to Arrive at Actual Claim Limitation

The motivation-to-combine portion of the obviousness inquiry is whether a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention. Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016); see also Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007).

A claim defines the invention whose obviousness is being assessed, and a skilled artisan may be motivated to combine particular features of different references, e.g., to secure some benefits at the expense of others, even when bodily incorporation would be impossible or inadvisable. See, e.g., In re Yamamoto, 740 F.2d 1569, 1573 (Fed. Cir. 1984); In re Urbanski, 809 F.3d 1237, 1243–44 (Fed. Cir. 2016). The issue is “why a person of ordinary skill in the art would have combined elements from specific references in the way the claimed invention does.” ActiveVideo Networks, Inc. v. Verizon Communications, Inc., 694 F.3d 1312, 1328 (Fed. Cir. 2012).

Implantable Electrode Leads for Sacral Nerve Stimulation

The Federal Circuit recently reiterated how to frame the motivation-to-combine question in Axonics Inc. v. Medtronic Inc., Nos. 2022-1451 & 2022-1452, __ F.4th __ (Fed. Cir. July 10, 2023).

The two patents-in-suit were directed towards an implantable neurostimulation lead and a method for implanting and anchoring the medical lead for stimulation of body tissue, particularly sacral nerves in one “preferred embodiment.” The patents describe and show 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.” The claims and titles of the patents, however, neither mentions nor is limited to sacral nerves.

This was an appeal of PTAB decisions from two IPRs which had held all the challenged claims were not unpatentable for obviousness based on a combination of a medical journal article (“Young”) in view of U.S. Patent No. 6055456 (“Gerber”). The PTAB defined the relevant art as sacral-nerve stimulation specifically, relying on the “field of the invention” statements.

The PTAB found that a relevant artisan would not 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—because they do not solve the same problem. Specifically, the patent-in-suit was directed towards providing sacral nerve stimulation; and Gerber addressed electrode implants in the sacral area via a non-percutaneous surgical procedure; but “Young addresses placement of an implanted, percutaneously placed electrode system for . . . stimulation of the trigeminal sensory root for treatment of chronic facial pain.” In short, the PTAB’s decision rested that finding on its determination that the proposed combination “would not be feasible in the trigeminal nerve region.”

The Federal Circuit, however, concluded that the PTAB’s rationale was “doubly infected by error.”

First, even if the Board was correct to treat the Medtronic patents at issue as limited in the problem they address to the sacral-nerve context, the Board committed a fundamental legal 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—to which the Medtronic patents are not limited. Second, the Board was incorrect in its view that “the relevant art is medical leads specifically for sacral neuromodulation,” J.A. 13, as the Medtronic patents’ claims are not limited to the sacral-nerve context and the shared specification, properly read, is not so limited either.

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The obviousness inquiry is not whether a relevant artisan would combine a first reference’s feature with a second reference’s feature to meet requirements of the first reference that are not requirements of the claims at issue.

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            The Board adopted a legally incorrect framing of the motivation-to-combine question 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. That context is not part of the Medtronic patents’ claims. The proper inquiry is whether the relevant artisan would be motivated to make the combination to arrive at the claims’ actual limitations, which are not limited to the trigeminal-nerve context. And the Board made no finding, and the parties have not pointed to evidence, that the space constraints of that context, on which the Board relied for finding no motivation to make the combination for trigeminal-nerve stimulation, are applicable to other nerve-stimulation contexts covered by the claims at issue, which include sacral-nerve stimulation.

The Federal Circuit further concluded that the PTAB erred in limiting its definition of “the relevant art” to medical leads for sacral-nerve stimulation.

            The Medtronic patent claims make no reference to sacral anatomy or sacral neuromodulation, and they cannot be properly construed as so limited. Neither the Board nor Medtronic has cited any authority for treating the relevant art as limited to a narrow subset of what the claims of a patent cover—a conclusion that would risk curtailing prior-art analysis of a claim to less than its exclusive-rights-protecting scope. And we have repeatedly ruled that what constitutes “analogous art” for section 103 purposes is tied to “the claimed invention.” See Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc., 66 F.4th 1373, 1377–78 (Fed. Cir. 2023) (citing and quoting cases).

The Federal Circuit also noted that “[t]he expressly broad scope of what was identified as invented is not negated by the fact that the specification notes a ‘need’ in the sacral-nerve context that may have supplied the inventor’s starting point.”

Finding that the error was not harmless, the Federal Circuit vacated the PTAB’s decision.

 

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