By Thomas Long, J.D.
An inter partes review (IPR) decision cancelling two challenged claims of a patent for implants for spinal fusion surgery has been vacated in part by the U.S. Court of Appeals for the Federal Circuit because the patent holder, NuVasive, Inc., did not receive adequate notice of a particular reading of a key prior art reference and its consequences for the overall obviousness analysis. At issue was a particular figure in a prior art reference that was not raised by the petitioner until its reply to NuVasive’s response to the review petition. The Board denied NuVasive’s request for an opportunity to address the newly asserted material; this refusal violated NuVasive’s rights under the Administrative Procedures Act, the court held. A related IPR decision—which invalidated several of the patent’s claims—was affirmed (In re NuVasive, Inc., November 9, 2016, Taranto, R.).
The patent at issue was U.S. Patent No. 8,187,334 ("the ’334 patent"). The spinal fusion implant of the ’334 patent was designed to be inserted between two vertebrae to replace a damaged or diseased intervertebral disc. Medtronic, Inc. filed two petitions for IPR (IPR507 and IPR508) challenging claims 1-5, 10, 11, and 14-28. The focus of the obviousness challenge was certain dimensions of the claimed implant—specifically a length that was both greater than 40 mm and at least 2.5 times the maximum width. The Patent Trial and Appeal Board cancelled all but one of the challenged claims under 35 U.S.C. §103. Key to its decision was a finding that a prior art patent ("Michelson") taught a spinal fusion implant that met two of the claim requirements of the ’334 patent—having a length both greater than 40 mm and at least 2.5 times its width. On appeal, NuVasive argued that it did not receive adequate notice of or opportunity to address that reading of Michelson. The Federal Circuit agreed in part.
In IPR507, the Board found that a prior art patent ("Frey") taught an implant with a length that was at least 2.5 times the width, and it accepted Medtronic’s argument that it would have been obvious to modify Frey to have a length greater than 40 mm, as taught by Michelson. The Board ultimately held, in IPR507, that claims 1-5, 10, 11, 14, 15, and 19-28 would have been obvious over Frey and Michelson, but it upheld claim 18. Key to the decision was a particular figure in Michelson ("Figure 18"), which taught the relevant length and width limitations. In the Federal Circuit’s view, NuVasive had a sufficient opportunity to respond to the obviousness contention made by Medtronic because the petition put NuVasive on notice of the assertion about Figure 18. The petition cited the Michelson text that specifically discussed Figure 18 in addition to nearby figures, and the petition did so in asserting that the text showed "longer than wide" implants. The court found no error with respect to the merits of the Board’s obviousness conclusions. Accordingly, the Board’s decision in IPR507 was affirmed.
The court reached a different conclusion, however, with respect to IPR508. In IPR508, Medtronic’s petition relied largely on two publications—the Synthes Vertebral Spacer-PR Brochure, Synthes Spine 2002 (SVS-PR), and the Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure and the accompanying Telamon Posterior Impacted Fusion Devices Guide 2003 (jointly, Telamon)—which taught implants whose lengths were at least 2.5 times their widths. Medtronic argued that it would have been obvious to modify either SVS-PR or Telamon to have lengths greater than 40 mm, as taught by Michelson. However, in that petition—unlike the petition in IPR507—Medtronic did not include an assertion about or citation to material encompassing Figure 18. Medtronic did not refer to Figure 18 during the IPR507 proceedings until its replies to NuVasive’s Patent Owner Responses. NuVasive objected to Medtronic’s argument regarding Figure 18, which it contended was a new ground for invalidity asserted for the first time on reply. NuVasive requested leave to file motions to strike or, alternatively, surreplies, which the Board denied. The Board concluded that claims 1-5, 10, 11, 14-17, and 19–28 would have been obvious over either SVS-PR or Telamon in view of Michelson and another reference ("Baccelli"), but it again upheld claim 18.
In IPR508, Medtronic’s petition did not notify NuVasive of the assertions about the pertinent portions of Michelson that were later deemed critical—specifically, the assertions related to Figure 18. In that proceeding, the Board’s ultimate reliance on that material, together with its refusal to allow NuVasive to respond fully once that material was called out, violated NuVasive’s rights under the Administrative Procedure Act. Due to this procedural violation, the Board’s cancellations in IPR508 were vacated, and the case was remanded for further proceedings regarding claims 16 and 17.
The case is Nos. 2015-1672 and 2015-1673.
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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