In Re: Nuvasive, Inc.
842 F.3d 1376
| Fed. Cir. | 2016Background
- NuVasive owns U.S. Patent No. 8,361,156 covering a non-bone spinal fusion implant with radiopaque markers positioned “proximate to said medial plane.”
- Medtronic petitioned for inter partes review (IPR), asserting claims 1–14, 19–20, and 23–27 were obvious over prior art including the SVS‑PR brochure, Telamon brochure/guide, and Baccelli.
- The PTAB instituted review and issued a Final Written Decision finding the challenged claims obvious over combinations of those references.
- NuVasive appealed, arguing (1) the SVS‑PR and Telamon materials were not printed publications (i.e., not publicly accessible), and (2) the PTAB failed to show a PHOSITA would have been motivated to place radiopaque markers near the medial plane.
- The Federal Circuit found NuVasive waived its public-accessibility challenge by not pressing it at trial before the PTAB, but concluded the PTAB’s obviousness analysis lacked adequate, explainable findings about motivation to combine and vacated and remanded for further explanation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the SVS‑PR brochure and Telamon references qualify as printed publications (publicly accessible) for IPR grounds | NuVasive: they were not publicly accessible and thus not proper printed publications | Medtronic/PTAB: treated the references as prior art printed publications | Waived — NuVasive abandoned the public‑accessibility challenge at the PTAB trial phase, so appellate review is foreclosed |
| Whether the PTAB adequately explained why a PHOSITA would be motivated to combine the prior art to place radiopaque markers proximate to the medial plane (obviousness) | NuVasive: PTAB failed to articulate a reasoned basis or evidentiary support showing motivation to combine | Medtronic/PTAB: argued a PHOSITA would combine references to obtain "additional information" and that the change is within ordinary skill/common sense | Not adequate — PTAB’s decision lacked reasoned, fact‑based findings on motivation to combine; vacated and remanded for fuller explanation |
Key Cases Cited
- In re Gartside, 203 F.3d 1305 (Fed. Cir.) (standard of review: factual findings substantial evidence; legal de novo)
- In re Kotzab, 217 F.3d 1365 (Fed. Cir.) (definition of substantial evidence)
- In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir.) (substantial evidence standard explained)
- In re Watts, 354 F.3d 1362 (Fed. Cir.) (appellate review confined to PTAB record; waiver principles)
- Harris Corp. v. Ericsson Inc., 417 F.3d 1241 (Fed. Cir.) (court discretion on waiver)
- Graham v. John Deere Co., 383 U.S. 1 (U.S.) (Graham factors for obviousness)
- United States v. Adams, 383 U.S. 39 (U.S.) (obviousness framework)
- In re Lee, 277 F.3d 1338 (Fed. Cir.) (need for specific, reasoned motivation‑to‑combine findings)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (U.S.) (motivation to combine and role of common sense)
- Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (U.S.) (agency must articulate satisfactory explanation)
- Synopsys, Inc. v. Mentor Graphics Corp., 814 F.3d 1309 (Fed. Cir.) (PTAB must give logical, rational reasons)
- Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir.) (affirmation allowed if agency path reasonably discernible)
- In re Huston, 308 F.3d 1267 (Fed. Cir.) (concise PTAB discussion must permit discernment of rationale)
- Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355 (Fed. Cir.) (cannot substitute unsupported "common sense" for reasoned analysis)
- In re Rouffet, 149 F.3d 1350 (Fed. Cir.) (cannot rely only on high level of skill in art without evidence)
