CAFC Reverses PTAB Finding for Patent Owner Due to Analysis ‘Doubly Infected by Error’

The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision finding the Patent Trial and Appeal Board (PTAB) erred in too narrowly confining its motivation-to-combine inquiry and improperly limiting its definition of the relevant art to hold that Axonics, Inc. had failed to prove Medtronic, Inc.’s patent claims obvious.

The patents at issue are Medtronic’s U.S. Patent Nos. 8,626,314 and 8,036,756. They cover “a neurostimulation lead and a method for implanting and anchoring the lead.” The ‘314 patent is a grandchild of the ‘756 patent and thus the court referred only to the ‘314 patent specification. The “Field of Invention” section reads:

“This invention relates generally to a method and apparatus that allows for stimulation of body tissue, particularly sacral nerves. More specifically, this invention relates to an implantable medical electrical lead having at least one stimulation electrode adapted to be implanted near the sacral nerves for stimulation of a bundle of sacral nerve fibers and a fixation mechanism for providing chronic stability of the stimulation electrode and lead. Moreover, this invention relates to the method of implantation and anchoring of the medical electrical lead electrodes in operative relation to a selected sacral nerve to allow for stimulation.”

Subsequent sections of the specification refer to uses not confined to sacral nerves and discuss electrostimulation devices for other parts of the body. The CAFC also noted that no claim of the two patents, nor either of their titles, mention or are limited to sacral nerves.

After Medtronic sued Axonics for infringement, Axonics filed two inter partes review (IPR) petitions challenging certain claims of each patent. Axonics argued that the ‘314 patent was obvious over a prior art reference titled Young in view of two other references, Gerber and Lindegren. Axonics said that Gerber and Young, like the ‘314 patent, “reasonably address[] the similar problems of leads adequately stimulating the nerves while limiting electrode migration” and that Gerber, Young and the ‘314 patent are all “from the same field”: “neurostimulation with implantable medical leads with electrode(s) at the distal end of the lead and a proximal anchoring mechanism.” Furthermore, said Axonics, Young’s express statement that the neurostimulator used in the clinical study “could be improved to provide multiple active stimulation sites near the tip” and Gerber’s disclosure of “multiple electrodes on implanted leads for sacral nerve stimulation” and an “anchoring means that fixes by fibrosis” also demonstrated motivation to combine.

The PTAB disagreed with Axonics and began by defining the relevant art and artisan as “focused on sacral-nerve stimulation specifically,” according to the CAFC’s opinion. The Board said that “the relevant art is medical leads specifically for sacral neuromodulation” and the relevant artisan is someone with “at least two years of experience researching and developing medical leads for sacral neuromodulation.” The Board found that Young, Gerber and the ‘314 patent don’t address the same problem—Gerber addresses “the positioning and securement of an electrode that is implanted in the sacral area via a non-percutaneous surgical procedure,” while “Young addresses placement of an implanted, percutaneously placed electrode system for . . .stimulation of the trigeminal sensory root for treatment of chronic facial pain,” and the ’314 patent “addresses the need for a percutaneously implantable lead that is properly and securely positioned to provide sacral nerve stimulation.”

Axonics’ petition on the ‘756 patent relied on the same combination of Young and Gerber as used in the ‘314 patent petition. Ultimately, the PTAB rejected both petitions for failure to show a motivation to combine.

On appeal, the CAFC said the Board’s reasoning was “doubly infected by error.” The Board looked to whether a motivation would exist to combine Young and Gerber for use in the trigeminal nerve context of Young, rather than to arrive at the limitations of Medtronics’ claims, “which are not limited to the trigeminal nerve context,” wrote the court.  “The Board thus improperly limited the Young-Gerber combination analysis to what would work in the trigeminal-nerve area,” wrote the CAFC. “That legally incorrect framing of its motivation inquiry was not harmless…. Vacatur and remand is necessary for this reason.”

The court next found that the PTAB also erred in its definition of the relevant art as being limited to medical leads for sacral-nerve stimulation. Even under the strict substantial evidence standard of review “we conclude that the Board’s ruling on the issue cannot stand,” wrote the court.

While the Field of Invention section of the specification, on which the Board relied for its interpretation, references sacral nerve stimulation, the CAFC said “that paragraph can readily be understood as identifying examples, not narrowing, even if read alone.” When read together with the Summary of the Invention section, which states the invention in general terms not limited to the sacral-nerve context, and the Summary, it is clear that sacral-nerve stimulation was just one preferred embodiment. “The 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,” wrote the court.

The decisions were thus vacated and remanded and costs awarded to Axonics.

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