In re Nuvasive, Inc.

• Decision Date: 07 December 2016
• Docket Number: 2015-1670
• Citation: 842 F.3d 1376,120 U.S.P.Q.2d 1821
• Parties: IN RE: NUVASIVE, INC., Appellant
• Court: U.S. Court of Appeals — Federal Circuit

842 F.3d 1376

120 U.S.P.Q.2d 1821

IN RE: NUVASIVE, INC., Appellant

2015-1670

United States Court of Appeals, Federal Circuit.

Decided: December 7, 2016

Michael T. Rosato , Wilson, Sonsini, Goodrich & Rosati, PC, Seattle, WA, argued for appellant. Also represented by Andrew Swanson Brown; Richard Torczon , Washington, DC; Grace J. Pak, Paul David Tripodi II, Los Angeles, CA.

Joseph Matal , Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for intervenor Michelle K. Lee. Also represented by Nathan K. Kelley, Scott Weidenfeller .

Before Moore, Wallach, and Taranto, Circuit Judges.

Wallach, Circuit Judge.

Appellant NuVasive, Inc. ("NuVasive") appeals the final written decision of the U.S. Patent and Trademark Office's ("USPTO") Patent Trial and Appeal Board ("PTAB"), finding claims 1–14, 19–20, and 23–27 of U.S. Patent No. 8,361,156 ("the '156 patent") invalid as obvious. See Medtronic, Inc. v. NuVasive, Inc. , No. IPR2013–00506, 2015 WL 996352, at *2 (P.T.A.B. Feb. 11, 2015). We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A) (2012). We vacate and remand.

BACKGROUND

NuVasive is the assignee of the '156 patent, which generally relates 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." '156 patent, Abstract. The '156 patent includes one independent claim (claim 1) and 26 dependent claims (claims 2–27). Illustrative claim 1 recites in relevant part:

A spinal fusion

implant of non-bone construction positionable within an interbody space between a first vertebra and a second vertebra, said implant comprising:

...

at least first and second radiopaque markers oriented generally parallel to a height of the implant, wherein said first radiopaque marker extends into said first sidewall at a position proximate to said medial plane , and said second radiopaque marker extends into said second sidewall at a position proximate to said medial plane .

Id. col. 12 ll. 32–67 (emphases added).

In response to Medtronic, Inc.'s ("Medtronic") petition,¹ the PTAB instituted the subject inter partes review to determine whether claims 1–14, 19–20, and 23–27 would have been obvious over, inter alia, a Synthes Vertebral Spacer–PR brochure ("SVS–PR brochure") (J.A. 769–70), a Telamon Verte–Stack PEEK Vertebral Body Spacer brochure ("Telamon brochure") (J.A. 771–72), a Telamon Posterior Impacted Fusion Devices guide ("Telamon guide") (J.A. 773–82), and U.S. Patent Application Publication No. 2003/0028249 ("Baccelli") (J.A. 744–51). See Medtronic, Inc. v. NuVasive, Inc. , No. IPR2013–00506, 2014 WL 1253040, at *11–12 (P.T.A.B. Feb. 13, 2014). The PTAB later issued the Final Written Decision concluding the claims would have been obvious over various combinations of, inter alia, the SVS–PR brochure, the Telamon brochure and Telamon guide (collectively, "the Telamon references"), and Baccelli. See Medtronic , 2015 WL 996352, at *14.

DISCUSSION

NuVasive argues that the PTAB's Final Written Decision should be reversed for two reasons: (1) "the [PTAB] erred in concluding that the SVS–PR brochure and Telamon references are printed publication prior art"; and (2) "the [PTAB] erred in concluding it would have been obvious to include radiopaque markers proximate to the medial plane." Appellant's Br. 22, 26 (capitalization omitted). After articulating the applicable standard of review, we address these arguments in turn.

I. Standard of Review

We review the PTAB's factual determinations for substantial evidence and its legal determinations de novo. See In re Gartside , 203 F.3d 1305, 1316 (Fed. Cir. 2000). "Substantial evidence is something less than the weight of the evidence but more than a mere scintilla of evidence."

In re Kotzab , 217 F.3d 1365, 1369 (Fed. Cir. 2000) (citation omitted). It is "such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." In re Applied Materials, Inc. , 692 F.3d 1289, 1294 (Fed. Cir. 2012) (internal quotation marks and citation omitted).

II. NuVasive Waived Its Arguments as to the PTAB's Treatment of the Prior Art References as Printed Publications

As an initial matter, the court must consider whether the SVS–PR brochure and Telamon references were publicly accessible such that they qualify as printed publications pursuant to 35 U.S.C. § 311(b)² and 35 U.S.C. § 102 (2006).³ Pursuant to § 311(b), "[a] petitioner in an inter partes review may request to cancel as unpatentable [one] or more claims of a patent only on a ground that could be raised under [§] 102 or [§] 103 and only on the basis of prior art consisting of patents or printed publications." 35 U.S.C. § 311(b). Section 102 provides that prior art includes "printed publication [s]" describing the invention either "before the invention thereof" or "more than one year prior to the date of the [patent] application...." 35 U.S.C. § 102(a), (b).

We first must determine whether NuVasive preserved its public accessibility arguments for appeal. In appeals from the PTAB, "we have before us a comprehensive record that contains the arguments and evidence presented by the parties and our review of the [PTAB]'s decision is confined to the four corners of that record." In re Watts , 354 F.3d 1362, 1367 (Fed. Cir. 2004) (internal quotation marks and citation omitted). While the court "retains case-by-case discretion over whether to apply waiver," Harris Corp. v. Ericsson Inc. , 417 F.3d 1241, 1251 (Fed. Cir. 2005) (citations omitted), we have held that a party waives an argument that it "failed to present to the [PTAB]" because it deprives the court of "the benefit of the [PTAB]'s informed judgment," Watts , 354 F.3d at 1367–68.

NuVasive waived its public accessibility arguments before the PTAB and may not raise them on appeal. NuVasive challenged the public accessibility of the prior art references during the preliminary proceedings of the inter partes review, J.A. 159–63 (section of NuVasive's Preliminary Response that addresses public accessibility), but failed to challenge public accessibility during the trial phase, J.A. 227–93 (NuVasive's Trial Response that fails to address public accessibility). In fact, during oral argument before the PTAB, NuVasive explicitly declined to make further arguments as to public accessibility of the Telamon references:

[PTAB Judge]: I take it you no longer are disputing the public availability of the Telamon reference[s]?

[NuVasive's Attorney]: That is correct , we're leaving that issue aside. We're focusing entirely on the obviousness to modify these markers in the medial plane. We're not abandoning the other arguments in our Patent Owner response, specifically with the dependent claims, we're just not addressing them right now because they're already addressed.

So, we're going to assume that these are prior art....

J.A. 527 (emphases added). NuVasive abandoned its challenge to the public accessibility determination even though the PTAB had warned NuVasive that this would result in waiver. J.A. 201–02 (where the PTAB indicated in a scheduling order that "[t]he patent owner is cautioned that any arguments for patentability not raised and fully briefed in the response will be deemed waived"). Because NuVasive no longer contested the public accessibility of the prior art references, the PTAB did not address this issue in the Final Written Decision. See generally Medtronic , 2015 WL 996352. As a result, we do not have "the benefit of the [PTAB]'s informed judgment" on the public accessibility issue, Watts , 354 F.3d at 1368, and NuVasive waived its arguments on this issue.

III. The PTAB Did Not Adequately Explain How Claim 1 of the '156 Patent Would Have Been Obvious Over the Prior Art

Having determined that NuVasive waived its arguments that the SVS–PR brochure and Telamon references were publicly accessible prior art, we examine whether the PTAB adequately set forth findings and explanations to support the conclusion that a combination of these prior art references would have rendered claim 1 of the '156 patent obvious. It did not.

A. Legal Standard for Obviousness

A patent claim is invalid as obvious "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the [relevant] art [ (‘PHOSITA’) ]...." 35 U.S.C. § 103(a) (2006).⁴ The ultimate determination of obviousness is a question of law, but that determination is based on underlying factual findings. See Gartside , 203 F.3d at 1316. The underlying factual findings include (1) "the scope and content of the prior art," (2) "differences between the prior art and the claims at issue," (3) "the level of ordinary skill in the pertinent art," and (4) the presence of secondary considerations of nonobviousness such "as commercial success, long felt but unsolved needs, failure of others," and unexpected results. Graham v. John Deere Co. , 383 U.S. 1, 17–18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966) ; United States v. Adams , 383 U.S. 39, 50–52, 86 S.Ct. 708, 15 L.Ed.2d 572 (1966).

In assessing the prior art, the PTAB "consider[s] whether a PHOSITA would have been motivated to combine the prior art to achieve the claimed invention." In re Warsaw Orthopedic, Inc. , 832 F.3d 1327, 1333 (Fed. Cir. 2016) (internal quotation marks, brackets, and citation omitted); see KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) ("[I]t can be important to identify a reason that would have prompted a [PHOSITA] to combine the elements in the way the claimed new invention does."). Although we review this factual finding for substantial evidence, "[t]he factual inquiry whether to combine references must be thorough and searching," and "[t]he need for specificity...