IP Law Daily In review of spinal fusion patent, PTAB must explain motivation to combine
Wednesday, December 7, 2016

In review of spinal fusion patent, PTAB must explain motivation to combine

By Thomas Long, J.D.

An inter partes review (IPR) decision finding that 21 challenged claims of a patent related to a system and method of spinal fusion surgery were invalid as obvious has been vacated by the U.S. Court of Appeals for the Federal Circuit. The Patent Trial and Appeal Board failed to articulate a motivation for skilled artisans to combine the prior art references to arrive at a key limitation of the challenged patent’s primary claim. Because the court could not "reasonably discern" the Board’s reasoning as to motivation to combine, judicial review could not be "meaningfully achieved." The case was remanded for additional findings and explanations (In re NuVasive, Inc., December 7, 2016, Wallach, E.).

Patent at issue. The patent at issue was U.S. Patent No. 8,361,156 ("the ’156 patent"), which generally related to a "system and method for spinal fusion comprising a spinal fusion implant of non-bone construction releasably coupled to an insertion instrument dimensioned to introduce the spinal fusion implant into any of a variety of spinal target sites." The only independent claim of the ’156 patent (claim 1) disclosed an implant two parallel radiopaque (opaque to X-rays) markers, which each extended into sidewalls of the implant at positions proximate to the medial plane.

IPR. Medtronic, Inc., filed a petition for IPR, and the Board instituted review of claims 1-14, 19-20, and 23-27. The Board determined that the challenged claims were obvious over various combinations of a Synthes Vertebral Spacer-PR brochure ("SVS-PR brochure"), a Telamon Verte-Stack PEEK Vertebral Body Spacer brochure ("Telamon brochure"), a Telamon Posterior Impacted Fusion Devices guide ("Telamon guide"), and U.S. Patent Application Publication No. 2003/0028249 ("Baccelli").

Arguments on appeal. On appeal, NuVasive argued that: (1) the Board erred in concluding that the SVS-PR brochure and Telamon references were printed publication prior art; and (2) the Board erred in concluding it would have been obvious to include radiopaque markers proximate to the medial plane.

Printed publications—waiver. Pursuant to Section 311(b) of the Patent Act, an IPR petitioner may request to cancel claims of a patent only on the basis of prior art consisting of patents or printed publications. Printed publications must be publicly available to qualify as prior art. The Federal Circuit held that NuVasive waived its arguments as to the Board’s treatment of the prior art references as printed publications. During oral arguments before the Board, NuVasive explicitly declined to pursue arguments regarding the availability of the references and focused entirely on the issue of obviousness, even though the Board warned NuVasive that this would result in waiver. Therefore, the SVS-PR brochure and the Telemon references were treated as publicly accessible prior art.

Obviousness—motivation to combine. The court next determined that the Board failed to adequately set forth findings and explanations as to how claim 1 would have been obvious over the prior art. Specifically, the Board failed to articulate why a person having ordinary skill in the art (PHOSITA) would have been motivated to combine the prior art references and place the radiopaque markers on the medial plane. According to the Federal Circuit, the Board relied on only one conclusory statement by Medtronic’s expert that the modification would provide "additional information." This was not sufficient to provide a "reasoned basis" for the Board’s invalidation of the challenged claims. It was not adequate for the Board to merely summarize NuVasive’s and Medtronic’s arguments without explaining why the Board accepted the prevailing argument and rejected the other. The Board never articulated why the additional information would benefit a PHOSITA when implanting a posterior lumbar interbody fusion implant, such as the implants disclosed by the prior art publications. It also failed to explain the type of additional information a PHOSITA would obtain or how the PHOSITA would use that information.

The Board’s decision was vacated, and the case was remanded for the Board to make additional findings and put forth explanations as to why the evidence affirmatively proved that the PHOSITA would have sought the additional information from the markers as positioned according to the teaching of claim 1.

The case is No. 2015-1670.

Attorneys: Michael T. Rosato (Wilson, Sonsini, Goodrich & Rosati, PC) for NuVasive, Inc. Joseph Matal, Office of the Solicitor, U.S. Patent and Trademark Office.

Companies: NuVasive, Inc.

MainStory: TopStory Patent FedCirNews

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