Auris Health, Inc. v. Intuitive Surgical Operations

32 F.4th 1154

• Court: Court of Appeals for the Federal Circuit
• Decided: April 29, 2022
• Docket: 21-1732
• Status: Published

Opinion

Case: 21-1732 Document: 44 Page: 1 Filed: 04/29/2022

United States Court of Appeals for the Federal Circuit ______________________

AURIS HEALTH, INC., Appellant

v.

INTUITIVE SURGICAL OPERATIONS, INC., Appellee ______________________

2021-1732 ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2019- 01533. ______________________

Decided: April 29, 2022 ______________________

RYAN C. MORRIS, Sidley Austin LLP, Washington, DC, argued for appellant. Also represented by THOMAS ANTHONY BROUGHAN, III; CHING-LEE FUKUDA, New York, NY; PAUL J. ROGERSON, Chicago, IL.

BENJAMIN AARON SAIDMAN, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Atlanta, GA, argued for appellee. Also represented by JACOB ADAM SCHROEDER, Palo Alto, CA; DANIEL C. TUCKER, Reston, VA. ______________________

Before DYK, PROST, and REYNA, Circuit Judges. Case: 21-1732 Document: 44 Page: 2 Filed: 04/29/2022

Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge REYNA. PROST, Circuit Judge. Auris Health, Inc. (“Auris”) petitioned for inter partes review of all five claims of Intuitive Surgical Operations, Inc.’s (“Intuitive”) U.S. Patent No. 8,142,447 (“the ’447 pa- tent”). In its final written decision, the Patent Trial and Appeal Board (“Board”) determined that Auris failed to demonstrate that the claims were unpatentable as obvious. Auris Health, Inc. v. Intuitive Surgical Operations, Inc., No. IPR2019-01533, Paper 45, 2021 WL 826396 (P.T.A.B. Mar. 3, 2021) (“Final Written Decision”). Although the Board agreed with Auris that its combination of two refer- ences disclosed every limitation of the challenged claims, the Board concluded that a skilled artisan wouldn’t have been motivated to combine those references. Auris ap- peals. Because the Board impermissibly rested its motiva- tion-to-combine finding on evidence of general skepticism about the field of invention, we vacate and remand. BACKGROUND The ’447 patent relates to robotic surgery systems. Specifically, the ’447 patent describes an improvement over Intuitive’s earlier robotic surgery systems, which allow surgeons to remotely manipulate surgical tools using a con- troller. ’447 patent col. 1 ll. 42–52. Surgery often requires a variety of surgical instruments like scissors, scalpels, and graspers, and clinicians must swap out instruments as they move from one surgical task to the next. Instrument swapping can prove tricky in a robotic surgical system where space is limited, different ranges of motion must be calibrated for different surgical instruments, and time is needed to interchange those instruments. The invention embodied by the ’447 patent attempts to address such dif- ficulties via a robotic system with a servo-pulley mecha- nism, which allows clinicians to more quickly swap out Case: 21-1732 Document: 44 Page: 3 Filed: 04/29/2022

AURIS HEALTH, INC. v. INTUITIVE SURGICAL OPERATIONS 3

surgical instruments and thereby reduce surgery time, im- prove safety, and increase reliability of the system. Id. at col. 2 ll. 50–57. The Board determined that Auris’s asserted prior-art combination—Smith and Faraz—disclosed each limitation of the challenged claims. See U.S. Patent No. 5,624,398 (“Smith”); U.S. Patent No. 5,824,007 (“Faraz”). The only issue that remained was whether a skilled artisan would have been motivated to combine Smith and Faraz. Final Written Decision, 2021 WL 826396, at *8. Smith discloses a robotic surgical system that uses an exoskeleton controller, worn by a clinician, to remotely ma- nipulate a pair of robotic arms, each of which holds a sur- gical instrument. Smith Abstract, Fig. 1A. Smith teaches using a servo-pulley system to mimic the clinician’s move- ments in the robotic arms. Id. at col. 6 ll. 46–67. However, Smith also provides that the clinician “may direct [an] Case: 21-1732 Document: 44 Page: 4 Filed: 04/29/2022

assistant to relocate the robot[ic] arms” as necessary. Id. at col. 8 ll. 48–51. Faraz discloses an adjustable support stand that holds surgical instruments. Faraz Abstract, Fig. 1. Faraz’s stand can be adjusted either manually or robotically. Id. at col. 6 ll. 23–29. Faraz provides that its stand “may enable a surgeon to perform surgery with fewer assistants” because its stand “can support multiple surgical imple- ments while [they] are being moved” and “can also provide support for a surgeon’s arms during long or complicated surgery.” Id. at col. 6 ll. 30–43. Case: 21-1732 Document: 44 Page: 5 Filed: 04/29/2022

AURIS HEALTH, INC. v. INTUITIVE SURGICAL OPERATIONS 5

Before the Board, Auris argued that a skilled artisan would be motivated to combine Smith and Faraz to de- crease the number of assistants needed during surgery by roboticizing some of their tasks. Intuitive responded that a skilled artisan wouldn’t have been motivated to combine the references because “surgeons were skeptical about per- forming robotic surgery in the first place, [so] there would have been no reason to further complicate Smith’s already complex robotic surgical system with [Faraz’s] roboticized surgical stand.” Final Written Decision, 2021 WL 826396, at *7–8. The Board agreed with Intuitive and concluded that “the evidence . . . supports the position [that] there is no motivation to complicate Smith’s system when there is skepticism at the time of the invention for using robotic systems during surgery in the first place.” Id. at *9. On appeal, Auris challenges the Board’s reliance on general skepticism about the field of robotic surgery to find a lack of motivation to combine. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A). DISCUSSION The motivation-to-combine inquiry asks whether a skilled artisan “not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis omit- ted). As to the “would have” question, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR Int’l Co. v. Te- leflex Inc., 550 U.S. 398, 420 (2007). It follows that generic industry skepticism cannot, standing alone, preclude a finding of motivation to combine. To be sure, evidence of industry skepticism may play a role in an obviousness inquiry—but as a secondary consid- eration in a significantly different context. See WBIP, Case: 21-1732 Document: 44 Page: 6 Filed: 04/29/2022

LLC v. Kohler Co., 829 F.3d 1317, 1335–36 (Fed. Cir. 2016). Yet even then, the evidence of skepticism must be specific to the invention, not generic to the field. Id. Although In- tuitive suggests that the Board may consider generic in- dustry skepticism in a motivation-to-combine analysis to “place [itself] in the minds of” skilled artisans, Appellee’s Br. 40–41 (citing Interconnect Plan. Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)), it offers no case law to suggest that the Board can rely on generic industry skepticism to find a lack of motivation to combine. And while specific evidence of industry skepticism related to a specific combi- nation of references might contribute to finding a lack of motivation to combine, that’s not what we have here. Here, the Board almost exclusively relied on evidence of general skepticism about the field of robotic surgery to find a lack of motivation to combine Smith and Faraz. In doing so, it credited Intuitive’s vague expert testimony that “there was great skepticism for performing telesurgery” at the time of the invention and, as a result, a skilled artisan “would not have been compelled to complicate Smith’s sys- tem further.” Final Written Decision, 2021 WL 826396, at *8. This is insufficient. It’s unclear how the Board would parse its impermissi- ble reliance on general industry skepticism from the rest of the record evidence on motivation to combine. The Board recited Auris’s evidence that combining Smith and Faraz would reduce the number of assistants but also Intuitive’s evidence that such a combination would come at the ex- pense of precision required for surgery. It would be inap- propriate for this court to weigh that evidence in the first instance on appeal. We therefore remand this case to the Board to examine the sufficiency of the record evidence to establish that there was a motivation to combine utilizing the correct criteria. Case: 21-1732 Document: 44 Page: 7 Filed: 04/29/2022

AURIS HEALTH, INC. v. INTUITIVE SURGICAL OPERATIONS 7

CONCLUSION We have considered the parties’ remaining arguments but find them unpersuasive. For the foregoing reasons, we vacate the Board’s Final Written Decision and remand for further consideration of the parties’ motivation-to-combine evidence. VACATED AND REMANDED COSTS No costs. Case: 21-1732 Document: 44 Page: 8 Filed: 04/29/2022

United States Court of Appeals for the Federal Circuit ______________________

INTUITIVE SURGICAL OPERATIONS, INC., Appellee ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2019- 01533. ______________________

REYNA, Circuit Judge, dissenting. I respectfully dissent. In my view, the Board’s deter- mination that Auris failed to show a motivation to combine is adequately supported by substantial evidence and was not contrary to our law on obviousness. See In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1373 (Fed. Cir. 2016) (“We review the Board’s legal conclusion of obviousness de novo, and underlying factual findings for substantial evi- dence.”); Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938) (Substantial evidence “means such relevant evi- dence as a reasonable mind might accept as adequate to support a conclusion.”). I agree with the majority that skilled artisans’ general skepticism toward robotic surgery, by itself, could be Case: 21-1732 Document: 44 Page: 9 Filed: 04/29/2022

insufficient to negate a motivation to combine. But I disa- gree that it could never support a finding of no motivation to combine. In any event, the Board here relied on more than just general skepticism to find no motivation to com- bine. In fact, the Board dedicated several pages to explain- ing multiple reasons why Auris’s proffered motivation to combine was inadequate. First, the Board credited Dr. Choset’s testimony, sup- ported by evidence, that “there was great skepticism for performing telesurgery, and because of this skepticism one of ordinary skill in the art at the time of the invention would not have been compelled to complicate Smith’s sys- tem further by including a robotic surgical stand.” Auris Health, Inc. v. Intuitive Surgical Operations, Inc., No. IPR2019-01533, 2021 WL 826396, at *8 (P.T.A.B. Mar. 3, 2021) (emphases added). Second, the Board found that the petitioner failed to “articulate how one would have combined Smith and Faraz to achieve the stated goal of re- ducing the number of assistants,” given that “Smith’s exo- skeleton has no remaining input degrees of freedom to control Faraz’s stand.” Id. at *9. Third, the Board credited Dr. Choset’s testimony that the combination would be un- acceptable because it “would have limited a physician’s ability to manipulate Smith’s servo-pulley tray and related components.” Id. Fourth, the Board credited Dr. Choset’s unrebutted testimony that adding joints to the system to achieve Auris’s proposed combination would “make[] it more difficult for the mechanical components in each joint to work with the amount of precision that is required for surgery” and would “create[] an effect known as ‘slop,’ which makes it increasingly difficult to track the position of each joint, as joint components and linkages bend or gear components experience backlash.” Id. The Board’s deter- mination was therefore supported on multiple grounds and did not solely rest on a vague “general skepticism” of ro- botic surgery. Case: 21-1732 Document: 44 Page: 10 Filed: 04/29/2022

I am also concerned that the majority opinion may rea- sonably be understood to announce an inflexible and rigid rule, namely that it is “impermissible” for the Board to con- sider evidence of artisans’ skepticism toward robotic sur- gery in determining motivation to combine. I find no authority for this assertion, and indeed it appears in ten- sion, at a minimum, with the central thrust of KSR. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007) (re- jecting the “rigid approach of the Court of Appeals” and ar- ticulating an “expansive and flexible approach” of determining obviousness). This is particularly true when considering art in fields of endeavor that are inherently dangerous or risky. Indeed, in past cases, this court has accounted for the attitudes of medical professionals toward certain types of procedures when determining whether a motivation to combine has been adequately demonstrated. See, e.g., Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012) (finding no motivation to combine where “doctors were not using the disclosed de- vices and methods to heal wounds with negative pressure because they did not believe that these devices were capa- ble of such healing”). We have also considered whether, as in this case, added complexity would have dissuaded a per- son of ordinary skill in the art from combining references. See, e.g., Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (affirming the Board’s finding of no motivation to combine where the Board “credited Fry- master’s expert’s testimony that following Iwaguchi’s method of diverting and cooling the oil in Kauffman’s sys- tem would introduce ‘additional plumbing and complex- ity’”). These exemplary cases call into question the majority’s holding that it was “impermissible” for the Board to rely on Dr. Choset’s testimony that (i) physicians were skeptical of robotic surgery at the time of invention, and (ii) this skepticism would have dissuaded a skilled ar- tisan from adding complexity by making the proposed com- bination. Case: 21-1732 Document: 44 Page: 11 Filed: 04/29/2022

I recognize that the majority states that skepticism “may play a role in an obviousness inquiry—but as a sec- ondary consideration.” Maj. Op. 5. But this assertion sug- gests, to some extent, that objective indicia are less important or less probative of obviousness or non-obvious- ness than the other Graham factors. The majority cites no case in which this court has endorsed that view, and in fact that view appears inconsistent with a number of our opin- ions. See, e.g., Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016) (en banc) (“A determination of whether a patent claim is invalid as obvious under § 103 requires consideration of all four Graham factors, and it is error to reach a conclusion of obviousness until all those factors are considered.”); Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1573 (Fed. Cir. 1996) (“It is the secondary considerations that are often most proba- tive and determinative of the ultimate conclusion of obvi- ousness or nonobviousness. The district court did not provide reasons for apparently discounting Pro-Mold’s evi- dence of secondary considerations; that was error as a mat- ter of law.”); Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1378 (Fed. Cir. 2012) (“These objective guideposts are pow- erful tools for courts faced with the difficult task of avoid- ing subconscious reliance on hindsight.”). In sum, the majority overlooks multiple reasons why the Board found the proffered motivation to combine insuf- ficient. It also announces a new legal principle that I be- lieve conflicts with KSR and its progeny. For these reasons, I dissent.