841 F.3d 966
Fed. Cir.2016Background
- NuVasive owns U.S. Patent No. 8,187,334 claiming a spinal-fusion implant with specific dimensional limits: length > 40 mm and length ≥ 2.5 × maximum width.
- Medtronic filed two inter partes review (IPR) petitions challenging the ’334 patent: IPR2013-507 (Frey + Michelson) and IPR2013-508 (SVS-PR/Telamon + Baccelli + Michelson). The Board instituted both proceedings.
- Medtronic’s IPR507 petition cited Michelson including text addressing Figure 18; the IPR508 petition did not cite the Figure 18 material.
- At institution and in final decisions the PTAB relied on Michelson’s Figure 18 (or the related text) to find an implant in the prior art that meets both dimensional limitations, enabling obviousness findings for most challenged claims.
- NuVasive objected that Figure 18 was treated as a new ground raised late (on reply) and that it was denied a meaningful opportunity to respond in IPR508; it appealed. The PTO Director intervened to defend the Board.
- The Federal Circuit affirmed the Board in IPR507, vacated the IPR508 decision, and remanded as to claims 16 and 17 for further proceedings.
Issues
| Issue | NuVasive's Argument | Medtronic / Board's Argument | Held |
|---|---|---|---|
| Whether the Board gave adequate pre-Response notice that Michelson’s Figure 18 disclosed an implant meeting both dimensional limits in IPR507 | Medtronic’s citation was insufficient to put NuVasive on specific notice of the Figure 18-based ratio argument | Petition cited Michelson text discussing Figure 18 and “longer than wide” implants; that was enough notice | Held: notice in IPR507 was minimally sufficient; no APA violation in IPR507 |
| Whether the Board gave adequate notice and opportunity to respond in IPR508 | IPR508 petition did not cite Figure 18; NuVasive had no chance to address that specific factual assertion before Petitioner’s reply | Board/Director: consolidated proceedings and Patent Owner observations provided adequate process | Held: IPR508 lacked required pre-Response notice and post-Reply opportunity to respond; APA violation — vacate and remand for claims 16–17 |
| Whether the Board’s finding that Michelson discloses an implant ≥40 mm and ≥2.5× width was speculative or supported | NuVasive: Figure 18/related text do not clearly disclose the 2.5 ratio; Board relied on speculation and improper combination of references | Medtronic/Board: Michelson’s preferred 42 mm length and 26 mm width plus depiction of multiple narrower implants supports inference that a narrower implant could be ≤13 mm, meeting the ratio; reliance was based on party arguments and intrinsic text | Held: substantial evidence supports Board’s reading of Michelson in IPR507; reliance was not speculative |
| Appropriate remedy given procedural defect in IPR508 | NuVasive: defective process warrants vacatur and remand so it can fully respond and submit evidence | Director: arguments that available procedural vehicles (cross-exam, observations) were sufficient; consolidation obviated separate notice | Held: vacatur and remand for further proceedings on claims 16 and 17; affirmed IPR507 cancellations for other claims |
Key Cases Cited
- In re Stepan Co., 660 F.3d 1341 (Fed. Cir.) (legal standard for when a new ground requires fresh opportunity to respond)
- Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir.) (notice and opportunity to respond under APA in IPR context)
- Dell Inc. v. Acceleron, LLC, 818 F.3d 1293 (Fed. Cir.) (petitioners’ later reliance on different portions of same prior art can create need for additional response opportunity)
- In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364 (Fed. Cir.) (Board may base decision on party-advanced arguments)
- Genzyme Therapeutic Prods. Ltd. v. Biomarin Pharm. Inc., 825 F.3d 1360 (Fed. Cir.) (when additional references merely describe state of the art and are not part of the prima facie case)
- In re Leithem, 661 F.3d 1316 (Fed. Cir.) (new thrust of rejection can create a new ground requiring notice)
- In re Kumar, 418 F.3d 1361 (Fed. Cir.) (vacatur and remand appropriate when Board should allow additional evidence after procedural error)
- In re Biedermann, 733 F.3d 329 (Fed. Cir.) (satisfying Board reply-rule does not alone cure lack of pre-Response notice)