Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01670/USCOURTS-ca13-15-01670-0/pdf.json

Parties Involved:
Medtronic, Inc.
Appellee
NuVasive, Inc.
Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

IN RE: NUVASIVE, INC.,

Appellant

______________________ 

2015-1670

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in No. IPR2013-

00506.

______________________ 

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 

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2 IN RE: NUVASIVE, INC. 

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).

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IN RE: NUVASIVE, INC. 3

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

1 Medtronic initially opposed NuVasive’s appeal, 

but later withdrew as Appellee. The USPTO intervened 

pursuant to 35 U.S.C. § 143 (2012) and, although it did 

not file a brief, participated at oral argument.

 

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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 concluconclusion.” 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 

2 Congress amended § 311 when it enacted the 

Leahy-Smith America Invents Act (“AIA”). Pub. L. 

No. 112-29, § 6(a), 125 Stat. 284, 299 (2011). Although 

the amendments to § 311 did not take effect until September 16, 2012, the amendments “apply to any patent 

issued before, on, or after th[e] effective date” and, thus, 

apply to the ’156 patent. See id. § 6(c)(2)(A), 125 Stat. 

at 304.

3 Congress amended § 102 when it enacted the AIA. 

Pub. L. No. 112-29, § 3(b)(1), 125 Stat. at 285–87. However, because the application that led to the ’156 patent was 

filed before March 16, 2013, the pre-AIA § 102 applies. 

See id. § 3(n)(1), 125 Stat. at 293. 

 

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IN RE: NUVASIVE, INC. 5

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]? 

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6 IN RE: NUVASIVE, INC. 

[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

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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 (1966); United States v. Adams, 383 U.S. 39, 50–52 

(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 (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 

4 Congress amended § 103 when it enacted the AIA. 

Pub. L. No. 112-29, § 3(c), 125 Stat. at 287. However, 

because the application that led to the ’156 patent was 

filed before March 16, 2013, the pre-AIA § 103 applies. 

See id. § 3(n)(1), 125 Stat. at 293. 

 

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8 IN RE: NUVASIVE, INC. 

for specificity pervades [our] authority” on the PTAB’s 

findings on motivation to combine. In re Lee, 277 F.3d 

1338, 1343 (Fed. Cir. 2002) (internal quotation marks and 

citations omitted); see id. (stating that “[t]his precedent 

has been reinforced in myriad decisions[] and cannot be 

dispensed with” and listing supporting precedent). 

B. The PTAB Failed to Articulate a Motivation to 

Combine the Prior Art References

NuVasive argues that, inter alia, the PTAB’s Final 

Written Decision did not make adequately explained 

findings as to why a PHOSITA would have been motivated to combine the prior art references and place the 

radiopaque markers on the medial plane. Appellant’s 

Br. 27–28. According to NuVasive, the PTAB relied on 

only one conclusory statement by Medtronic’s expert that 

the modification would provide “additional information.” 

Id. (emphasis omitted). We agree with NuVasive. 

Two distinct yet related principles are relevant to our 

review. First, the PTAB must make the necessary findings and have an adequate “evidentiary basis for its 

findings.” Lee, 277 F.3d at 1344. Second, the PTAB 

“must examine the relevant data and articulate a satisfactory explanation for its action including a rational 

connection between the facts found and the choice made.” 

Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. 

Co., 463 U.S. 29, 43 (1983) (internal quotation marks and 

citation omitted); see Synopsys, Inc. v. Mentor Graphics 

Corp., 814 F.3d 1309, 1322 (Fed. Cir. 2016) (stating that, 

as an administrative agency, the PTAB “must articulate 

logical and rational reasons for [its] decisions” (internal 

quotation marks and citation omitted)). 

This explanation enables the court to exercise its duty 

to review the PTAB’s decisions to assess whether those 

decisions are “arbitrary, capricious, an abuse of discretion, 

or . . . unsupported by substantial evidence . . . .” 5 U.S.C. 

§ 706(2)(A)–(E) (2012); see Dickinson v. Zurko, 527 U.S. 

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IN RE: NUVASIVE, INC. 9

150, 152 (1999) (holding that § 706 governs our reviews of 

the USPTO’s findings of fact and providing the framework 

for this review). We “cannot exercise [our] duty of review 

unless [we] are advised of the considerations underlying 

the action under review.” SEC v. Chenery Corp., 318 U.S. 

80, 94 (1943). Indeed, “the orderly functioning of the 

process of review requires that the grounds upon which 

the [PTAB] acted be clearly disclosed and adequately 

sustained.” Id. Although we do not require perfect explanations, we may affirm the PTAB’s findings “if we may 

reasonably discern that it followed a proper path, even if 

that path is less than perfectly clear.” Ariosa Diagnostics 

v. Verinata Health, Inc., 805 F.3d 1359, 1365 (Fed. Cir. 

2015) (citation omitted).

The relevant principles apply with equal force to the 

PTAB’s motivation to combine analysis. Our precedent

dictates that the PTAB must make a finding of a motivation to combine when it is disputed. See, e.g., Lee, 277 

F.3d at 1343–45; see also KSR, 550 U.S. at 418 (stating 

that the PTAB’s motivation to combine “analysis should 

be made explicit” (citation omitted)). Although identifying 

a motivation to combine “need not become [a] rigid and 

mandatory formula[],” KSR, 550 U.S. at 419, the PTAB 

must articulate a reason why a PHOSITA would combine 

the prior art references. 

Our recent decisions demonstrate that the PTAB 

knows how to meet this burden. For example, in Nike, 

Inc. v. Adidas AG, we affirmed the PTAB’s finding of a 

motivation to combine where it determined that a 

PHOSITA “interested in Nishida’s preference to minimize 

waste in the production process would have logically 

consulted the well-known practice of flat-knitting, which 

eliminates the cutting process altogether.” 812 F.3d 1326, 

1337 (Fed. Cir. 2016) (emphasis added). Thus, a 

PHOSITA “would have been motivated to address the 

problem identified in Nishida by applying the teachings of 

the Schuessler References to arrive at the invention in 

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10 IN RE: NUVASIVE, INC. 

Nike’s proposed substitute claims.” Id. Similarly, in 

Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, we affirmed the PTAB’s explanation that “a 

skilled artisan could modify Caterpillar in view of Ogawa 

by treating the first jaw like the second” to “allow[] for a 

greater degree of movement between the jaws, without 

impacting the quick change functionality . . . .” 825 F.3d 

1373, 1381 (Fed. Cir. 2016) (emphasis added) (citations 

omitted). In each of these cases, the PTAB identified a 

reason why a PHOSITA would have combined the prior 

art references—i.e., “minimiz[ing] waste” (Nike, 812 F.3d 

at 1337) and “allow[ing] for a greater degree of movement” (Allied, 825 F.3d at 1381)—that had a foundation 

in the prior art.

The PTAB must provide “a reasoned basis for the 

agency’s action,” and “we will uphold a decision of less 

than ideal clarity if the agency’s path may reasonably be 

discerned.” Bowman Transp., Inc. v. Ark.-Best Freight 

Sys., Inc., 419 U.S. 281, 285, 286 (1974). The PTAB’s own 

explanation must suffice for us to see that the agency has 

done its job and must be capable of being “reasonably . . . discerned” from a relatively concise PTAB discussion. In re Huston, 308 F.3d 1267, 1281 (Fed. Cir. 2002).

We have, however, identified some insufficient articulations of motivation to combine. First, “conclusory 

statements” alone are insufficient and, instead, the finding must be supported by a “reasoned explanation.” Lee, 

277 F.3d at 1342, 1345. Second, it is not adequate to

summarize and reject arguments without explaining why 

the PTAB accepts the prevailing argument. See 

Cutsforth, Inc. v. MotivePower, Inc., 636 F. App’x 575, 578 

(Fed. Cir. 2016) (“The majority of the [PTAB]’s Final 

Written Decision is spent summarizing the parties’ arguments and offers only conclusory analysis of its own. 

While the decision does specify when it is rejecting a 

party’s argument, the [PTAB] does not explain why it 

accepts the remaining arguments as its own analysis. 

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This leaves little explanation for why the [PTAB] found 

the claimed invention obvious.”). Third, although reliance 

on common sense may be appropriate in some circumstances, see KSR, 550 U.S. at 421 (“Rigid preventative 

rules that deny factfinders recourse to common 

sense . . . are neither necessary under our case law nor 

consistent with it.”), the PTAB cannot rely solely on 

common knowledge or common sense to support its findings, see Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 

1362 (Fed. Cir. 2016) (“[R]eferences to ‘common 

sense’ . . . cannot be used as a wholesale substitute for 

reasoned analysis and evidentiary support . . . .”); see also 

In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998) (explaining that the Board of Patent Appeals and Interferences cannot simply invoke “the high level of skill in the 

art” as proof positive of its findings).

With these principles in mind, we turn to the PTAB’s 

findings regarding motivation to combine. Here, the 

PTAB acknowledged that the key issue was “whether it 

would have been obvious to [a PHOSITA] to combine the 

cited references,” Medtronic, 2015 WL 996352, at *6, and 

then found that independent claim 1 would have been 

obvious over a combination of Baccelli and either the SVSPR brochure or the Telamon references, see id. at *5–8. 

In reaching this conclusion, the PTAB failed to explain

the reason why a PHOSITA would have been motivated to 

modify either the SVS-PR or Telamon implants, in light of 

Baccelli, to place radiopaque markers “proximate to said 

medial plane” (i.e., near the middle of the implant), as the 

’156 patent teaches. The majority of the PTAB’s analysis 

was limited to summaries of the parties’ arguments, as 

the USPTO acknowledged during oral argument. See 

Oral Argument at 14:30–15:55, http://oralarguments.cafc.

uscourts.gov/default.aspx?fl=2015-1670.mp3. The PTAB 

began by summarizing Medtronic’s and NuVasive’s arguments on whether the “additional information” that could 

be obtained from placing radiopaque markers near the 

middle of the implant would benefit a PHOSITA. See 

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12 IN RE: NUVASIVE, INC. 

Medtronic, 2015 WL 996352, at *6–7 (citing, inter alia,

J.A. 591 (Medtronic’s expert’s statement that a PHOSITA 

“would have considered it to be common sense” to place 

radiopaque markers along the medial plane “to provide 

additional information regarding the orientation or location of an implant”)). The PTAB stated “[w]e are not 

persuaded by [NuVasive]’s argument, because the question is whether it would have been obvious to [a 

PHOSITA] to combine the cited references, and not 

whether any specific implants on the market contain a 

radiopaque marker in a central region.” Id. at *6. In 

addition, the PTAB invoked the high level of skill in the 

art when it “agree[d]” with Medtronic’s assertion that “the 

addition of markers along the medial plane would not 

confuse” a PHOSITA and found that NuVasive’s argument “vastly underestimates the ordinary skill of surgeons in this field.” Id. at *7 (citation omitted). However, 

the PTAB never actually made an explanation-supported 

finding that the evidence affirmatively proved that the 

PHOSITA would have sought this additional information. 

The PTAB avers that it “effectively” adopted Medtronic’s arguments, Oral Argument at 14:52–15:11, 

http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20

15-1670.mp3, but the PTAB neither expressly did so nor 

provided reasoned explanations for crediting the arguments. Medtronic’s arguments amount to nothing more 

than conclusory statements that a PHOSITA would have 

been motivated to combine the prior art references to 

obtain additional information. In its summary of Medtronic’s arguments, the PTAB 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 SVS-PR brochure 

and the Telamon references. It also failed to explain the 

type of additional information a PHOSITA would obtain 

or how the PHOSITA would use that information. Although the PTAB did “credit the testimony” of NuVasive’s 

expert that placing radiopaque markers along the medial 

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plane “would provide . . . better alignment of the implant,” 

Medtronic, 2015 WL 996352, at *7 (internal quotation 

marks, brackets, and citation omitted), NuVasive’s expert’s statement was made in reference to benefits recognized after the priority date of the ’156 patent, J.A. 4893 

(explaining that these “uses were not disclosed in the 

cited prior art references”). This statement addresses

neither the benefits that could have been obtained by 

combining the prior art references nor the PHOSITA’s 

motivation to combine at the time of the invention. 

In sum, the PTAB failed to articulate a reason why

the PHOSITA would have been motivated to modify the 

SVS-PR or Telamon implants, in light of Baccelli, to 

obtain this additional information. Because we cannot 

“reasonably discern” the PTAB’s reasoning as to motivation to combine, Ariosa, 805 F.3d at 1365 (citation omitted), judicial review cannot “meaningfully [be] achieved,” 

Lee, 277 F.3d at 1342. Therefore, the PTAB’s decision is 

vacated and the case remanded for additional PTAB 

findings and explanations regarding the PHOSITA’s 

motivation to combine the prior art references. 

CONCLUSION

We have considered the parties’ remaining arguments 

and find them unpersuasive. For these reasons, the Final 

Written Decision of the U.S. Patent and Trademark 

Office’s Patent and Trial Appeal Board is 

VACATED AND REMANDED

COSTS

Each party shall bear its own costs.

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