Court Opinion

ID: 6346506
Source: CourtListenerOpinion
Date Created: 2022-06-03 14:02:37.322518+00
Date Added: 2024-06-11T09:18:19.871333
License: Public Domain

Case: 21-1995     Document: 42    Page: 1   Filed: 05/23/2022

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                   ______________________

                     ETHICON LLC,
                       Appellant

                             v.

                INTUITIVE SURGICAL, INC.,
                          Appellee
                   ______________________

                    2021-1995, 2021-1997
                   ______________________

     Appeals from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in Nos. IPR2020-
 00050, IPR2020-00051.
                  ______________________

                   Decided: May 23, 2022
                   ______________________

    ANISH R. DESAI, Weil, Gotshal & Manges LLP, New
 York, NY, argued for appellant. Also represented by ADAM
 BANKS, ELIZABETH WEISWASSER; PRIYATA PATEL,
 CHRISTOPHER PEPE, Washington, DC.

    STEVEN KATZ, Fish & Richardson PC, Boston, MA, ar-
 gued for appellee. Also represented by KENTON W.
 FREEMAN, JR., Washington, DC; RYAN PATRICK O'CONNOR,
 JOHN C. PHILLIPS, San Diego, CA.
                 ______________________
Case: 21-1995     Document: 42       Page: 2   Filed: 05/23/2022

 2                     ETHICON LLC   v. INTUITIVE SURGICAL, INC.

     Before NEWMAN, REYNA, and HUGHES, Circuit Judges.
      Opinion for the court filed by Circuit Judge REYNA.
      Dissenting opinion filed by Circuit Judge NEWMAN.
 REYNA, Circuit Judge.
     Appellant Ethicon LLC appeals a final written decision
 issued in two consolidated inter partes review proceedings
 where the Patent Trial and Appeal Board concluded that
 the challenged claims are unpatentable as obvious. Ethi-
 con contends that the Board committed legal error by plac-
 ing the burden of proof on Ethicon, the patent owner.
 Ethicon also contends that the Board’s finding of a reason-
 able expectation of success in combining the asserted prior
 art is unsupported by substantial evidence. 1 We affirm.
                         BACKGROUND
     Ethicon owns U.S. Patent No. 9,844,379 B2 (the
 “’379 Patent”), titled “Surgical stapling instrument having
 a clearanced opening.” The ’379 Patent relates to an endo-
 scopic surgical stapling tool. The purported novelty of the
 claimed invention is the use of both an I-beam firing mem-
 ber and a no-cartridge safety lockout, such that the lockout
 blocks the advancement of an I-beam firing member when
 there is no staple cartridge loaded in the stapling assembly.
 See Appellant’s Br. 1–3. This safety mechanism is partic-
 ularly useful for endoscopic procedures, which require a

      1   Ethicon also argued in its opening brief that the
 Board’s finding of a motivation to combine is unsupported
 by substantial evidence. Appellant’s Br. 56–69. Ethicon
 conceded this issue at oral argument, so we do not reach
 the question here. Oral Arg. 8:00–8:30. We note, however,
 that the absence of that waiver would not affect our dispo-
 sition in this case.
Case: 21-1995      Document: 42     Page: 3   Filed: 05/23/2022

 ETHICON LLC   v. INTUITIVE SURGICAL, INC.                  3

 surgeon to work with reduced visual and tactile feedback
 as compared to open surgery. Id.
     On October 16, 2019, Appellee Intuitive Surgical, Inc.
 (“Intuitive”) filed two petitions for inter partes review
 (“IPR”) of claims 1–3 of the ’379 Patent. Intuitive Surgical,
 Inc. v. Ethicon LLC, Nos. IPR2020-00050, IPR2020-00051,
 2021 WL 1158290, at *1 (P.T.A.B. Mar. 26, 2021). On
 March 31, 2020, the Board instituted the IPRs on the
 ground that claims 1–3 are unpatentable as obvious over
 U.S. Patent No. 4,429,695 (“Green”) in view of U.S. Patent
 No. 5,413,267 (“Solyntjes”). 2 Id.
     Green, titled “Surgical instruments,” describes a “sur-
 gical stapling instrument” with “upper and lower elongate
 jaws for receiving a staple cartridge and an anvil respec-
 tively.” J.A. 5157. Green accounts for the majority of the
 claimed features in the ’379 Patent, including a frame, a
 distal end, a first jaw with a channel, and a channel re-
 tainer. See Intuitive Surgical, 2021 WL 1158290, at *6–7.
     Solyntjes, titled “Surgical stapler with spent cartridge
 sensing and lockout means,” is directed to surgical stapling
 instruments “for applying linear parallel rows of staggered
 staples through compressed living tissue.” J.A. 5146.
 Solyntjes teaches that there are benefits to equipping a
 surgical stapler instrument with a locking pin to prevent
 the instrument’s firing when it is loaded with an empty sta-
 pler cartridge, as doing so “reduces the chances of unneces-
 sary tissue trauma, blood loss, inadequate hemostasis, and
 squandered time during surgery.” Solyntjes col. 2 ll. 65–
 68.

     2   The Board also instituted IPR on other grounds.
 See Intuitive Surgical, 2021 WL 1158290, at *1. We do not
 address those grounds, as they are not at issue on appeal.
Case: 21-1995    Document: 42       Page: 4   Filed: 05/23/2022

 4                    ETHICON LLC   v. INTUITIVE SURGICAL, INC.

             BOARD’S FINAL WRITTEN DECISION
     During IPR, Ethicon conceded that Green and
 Solyntjes disclose all the elements claimed by the chal-
 lenged claims. Intuitive Surgical, 2021 WL 1158290, at *7.
 Ethicon argued, however, that a person of ordinary skill in
 the art (“POSITA”) (1) would not have been motivated to
 combine Green with Solyntjes, and (2) would not have had
 a reasonable expectation of success in doing so. Id. On
 March 26, 2021, the Board issued a consolidated final writ-
 ten decision addressing both issues.
                   Motivation to Combine
      With respect to the question of a motivation to combine,
 Intuitive relied on testimony from its expert, Dr. Knodel,
 to argue that a POSITA would have recognized Solyntjes’s
 locking mechanism would make Green’s instrument safer
 and more efficient. Id. at *6–8. Ethicon, on the other hand,
 relied on testimony from its own expert, Dr. Fronczak, to
 argue that there would be no motivation to combine the ref-
 erences because Green already provides the user with tac-
 tile and visual feedback as to the presence or absence of a
 staple cartridge. Id. at *7–8. The Green instrument was
 for use in open surgery whereby the instrument was in the
 surgeon’s field of vision. See Appellant’s Br. 3.
     The Board determined that Dr. Fronczak’s expert opin-
 ion relied too much on “speculation as to a user’s awareness
 or cognizance during use of Green’s surgical stapler instru-
 ment as to the presence or absence of a stapler cartridge.”
 Id. at *7. The Board instead found that a POSITA would
 have been motivated to combine the references because:
     In particular, Solyntjes clearly sets forth that a
     locking mechanism is valuable, as the dangers of
     firing a surgical stapler instrument without a sta-
     pler cartridge being present are significant, includ-
     ing the risk of “unnecessary tissue trauma, blood
Case: 21-1995      Document: 42     Page: 5   Filed: 05/23/2022

 ETHICON LLC   v. INTUITIVE SURGICAL, INC.                  5

    loss, inadequate hemostasis, and squandered time
    during surgery.” [Solyntjes col. 2 ll. 65–68].
    [. . .]
    It defies reason to conclude that a skilled artisan
    would not have recognized readily the benefit of
    employing a locking mechanism specifically di-
    rected to preventing such firing. That is logically
    so even if a user may already have an avenue to
    recognize the presence or absence of a staple car-
    tridge, such as through visual or tactile feedback,
    as mere recognition in that regard is not under-
    stood to actually prevent the firing of a cartridge-
    less stapler. [Suppl. Decl. of Dr. Knodel ¶¶ 15–20].
 Id. The Board also noted that Dr. Fronczak admitted it
 would be “catastrophic” and a “hazard” if a user failed to
 notice the absence of a stapler cartridge before attempting
 to fire the instrument. Id. Accordingly, the Board found
 that Intuitive sufficiently established a motivation to com-
 bine Green with Solyntjes.
               Reasonable Expectation of Success
     With respect to the question of a reasonable expecta-
 tion of success, Ethicon proffered testimony from
 Dr. Fronczak supporting its contention that a POSITA
 “would be incapable of implementing a ‘spring-and-pin
 lockout mechanism,’ such as that disclosed in Solyntjes,
 into a surgical stapler instrument having the particular
 structural characteristic of Green’s instrument.” Id. at *8.
 The Board discredited this testimony because it was “based
 on little evidentiary support in the record” and “instead
 largely premised on Dr. Fronczak’s speculation that physi-
 cal difficulties or impediments in modifying Green’s instru-
 ment would have been insurmountable.” Id.
     The Board credited the testimony of Dr. Knodel that a
 POSITA would know how to modify Green’s stapler with
 the lockout taught in Solyntjes. Id. at *9. The Board found
Case: 21-1995     Document: 42      Page: 6   Filed: 05/23/2022

 6                    ETHICON LLC   v. INTUITIVE SURGICAL, INC.

 Dr. Knodel’s testimony “logical and credible,” as “appropri-
 ately reflect[ing] the types of design assessments that such
 a skilled artisan would have employed in seeking to im-
 prove Green’s instrument based on Solyntjes’s teachings as
 to a locking pin mechanism so as to harness the benefits of
 such a mechanism.” Id. Recalling that “[b]oth parties
 agree[d] that the level of ordinary skill in the relevant art
 includes someone with a degree in mechanical engineering
 and at least three years of design experience in surgical in-
 struments,” the Board found that a motivated POSITA
 would be able to “account for routine considerations, e.g.,
 location, positioning, and robustness of a locking mecha-
 nism, as a part of Green’s instrument.” Id.
     Ultimately, the Board concluded that Intuitive estab-
 lished by a preponderance of the evidence that claims 1–3
 of the ’379 Patent are unpatentable as obvious. Id. at *10.
 Ethicon appeals.      We have jurisdiction pursuant to
 28 U.S.C. § 1295(a)(4)(A).
                    STANDARD OF REVIEW
     We review the Board’s legal conclusions de novo and its
 factual findings for substantial evidence. ACCO Brands
 Corp. v. Fellowes, Inc., 813 F.3d 1361, 1365 (Fed. Cir.
 2016). Substantial evidence “means such relevant evi-
 dence as a reasonable mind might accept as adequate to
 support a conclusion.” In re Gartside, 203 F.3d 1305, 1312
 (Fed. Cir. 2000) (quoting Consol. Edison Co., Inc. v. NLRB,
 305 U.S. 197, 229–30 (1938)).
     Obviousness is a question of law with underlying fac-
 tual issues relating to the scope and content of the prior
 art, differences between the prior art and the claims at is-
 sue, the level of ordinary skill in the pertinent art, and any
 objective indicia of non-obviousness. Randall Mfg. v. Rea,
 733 F.3d 1355, 1362 (Fed. Cir. 2013) (citing KSR Int’l Co.
 v. Teleflex Inc., 550 U.S. 398, 406 (2007); Graham v. John
 Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966)).
 Whether a skilled artisan would have been motivated to
Case: 21-1995      Document: 42     Page: 7   Filed: 05/23/2022

 ETHICON LLC   v. INTUITIVE SURGICAL, INC.                  7

 combine references in an obviousness determination is a
 pure question of fact, which we review for substantial evi-
 dence. Par Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d
 1186, 1196 (Fed. Cir. 2014) (quoting Alza Corp. v. Mylan
 Lab’ys, Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006)).
 Whether a skilled artisan would have had a reasonable ex-
 pectation of success in combining references is also a ques-
 tion of fact. Id. (citation omitted).
                          DISCUSSION
     On appeal, Ethicon argues that the Board improperly
 placed the burden on Ethicon as the patentee to disprove
 that a POSITA would have had a reasonable expectation of
 success in combining Green and Solyntjes. Appellant’s
 Br. 41–51. Ethicon also argues that the Board’s finding of
 a reasonable expectation of success is unsupported by sub-
 stantial evidence. Id. at 51–56.
                                I
     We first address whether the Board improperly placed
 the burden of proof on Ethicon. The fact that the petitioner
 bears the burden of proof in a Board proceeding does not
 eliminate the patent owner’s burden to proffer opposing ev-
 idence against the petitioner’s showing of unpatentability.
 See Novo Nordisk A/S v. Caraco Pharm. Lab’ys, Ltd.,
 719 F.3d 1346, 1353 (Fed. Cir. 2013). In resolving a claim
 of obviousness, the Board should consider the totality of ev-
 idence proffered by both parties to resolve any subsidiary
 factual inquiries, such as the scope and content of the prior
 art, the existence of a motivation to combine, the existence
 of a reasonable expectation of success, or the existence of
 any objective indicia of non-obviousness. The petitioner
 bears the burden to demonstrate by a preponderance of the
 evidence that the patent is invalid. See 35 U.S.C. § 316.
 And while the unpatentability inquiry must remain fo-
 cused on whether the petitioner has borne its burden, that
 the Board addresses the patentee’s counterarguments is
 not an improper shifting of burdens. See, e.g., Bos. Sci.
Case: 21-1995    Document: 42       Page: 8   Filed: 05/23/2022

 8                    ETHICON LLC   v. INTUITIVE SURGICAL, INC.

 SciMed, Inc. v. Iancu, 811 F. App’x 618, 626 (Fed. Cir.
 2020) (citing Novo Nordisk, 719 F.3d at 1353).
      Here, the Board received competing expert testimony
 and found Intuitive’s expert, Dr. Knodel, more credible
 than Ethicon’s expert, Dr. Fronczak. The Board found that
 Dr. Knodel logically and credibly opined that a POSITA
 would have had a reasonable expectation of success in com-
 bining Green with Solyntjes because an individual with a
 mechanical engineering degree and at least three years of
 experience designing surgical instruments would have
 been capable of performing routine modifications to imple-
 ment Solyntjes’s lockout mechanism in Green’s stapler.
 The Board also found Dr. Fronczak’s testimony unsup-
 ported by the record and largely speculative. This is not
 indicative of a situation where the Board improperly
 shifted the burden of proof on the patent owner to establish
 non-obviousness in the first instance, as Ethicon argues.
 Rather, the Board weighed competing evidence and made
 its determination on the record as a whole.
                              II
     We also conclude that substantial evidence supports
 the Board’s finding that a POSITA would have had a rea-
 sonable expectation of success in combining Green and
 Solyntjes. Evidence of a reasonable expectation of success,
 just like evidence of a motivation to combine, “may flow
 from the prior art references themselves, the knowledge of
 one of ordinary skill in the art, or, in some cases, from the
 nature of the problem to be solved.” Brown & Williamson
 Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125
 (Fed. Cir. 2000) (citing Pro-Mold & Tool Co. v. Great Lakes
 Plastics, Inc., 75 F.3d 1568, 1573 (Fed. Cir. 1996)).
     Here, as discussed above, the Board credited
 Dr. Knodel’s testimony that a POSITA would have had a
 reasonable expectation of success in modifying the surgical
 stapling instrument of Green to include the lockout mech-
 anism of Solyntjes. Intuitive Surgical, 2021 WL 1158290,
Case: 21-1995      Document: 42      Page: 9   Filed: 05/23/2022

 ETHICON LLC   v. INTUITIVE SURGICAL, INC.                   9

 at *9. The Board acknowledged Ethicon’s argument that
 the combination would require some modifications to fit
 pieces of the invention together. The Board relied, how-
 ever, on Dr. Knodel’s testimony that a POSITA would know
 how to account for “routine considerations” such as “loca-
 tion, positioning, and robustness of a locking mechanism,
 as a part of Green’s instrument.” Id. And although
 Dr. Fronczak testified that a POSITA would be “incapable”
 of combining the references, the Board discredited his tes-
 timony as speculative and unsupported by evidence in the
 record. Id. at *8. In view of the foregoing, we conclude that
 the Board’s finding of a reasonable expectation of success
 is supported by substantial evidence, especially in light of
 the parties’ stipulation regarding the relative skill and ex-
 perience level of a POSITA in this case.
                          CONCLUSION
     In summary, we hold that the Board did not misplace
 the burden of proof on the patentee and that substantial
 evidence supports the Board’s finding that a POSITA
 would have had a reasonable expectation of success in com-
 bining the asserted references. Thus, we affirm the Board’s
 final written decision concluding that claims 1–3 of the ’379
 Patent are unpatentable as obvious.
                         AFFIRMED
                             COSTS
 Costs to Appellee.
Case: 21-1995     Document: 42     Page: 10   Filed: 05/23/2022

         NOTE: This disposition is nonprecedential.

    United States Court of Appeals
        for the Federal Circuit
                   ______________________

                      ETHICON LLC,
                        Appellant

                              v.

                INTUITIVE SURGICAL, INC.,
                          Appellee
                   ______________________

                    2021-1995, 2021-1997
                   ______________________

     Appeals from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in Nos. IPR2020-
 00050, IPR2020-00051.
                  ______________________
 NEWMAN, Circuit Judge, dissenting.
     I respectfully dissent. The court reconstructs a novel
 surgical device from components of known devices, using
 the ’379 patent as a template for the reconstruction. The
 court finds that an engineer with at least three years of ex-
 perience in designing surgical instruments would have
 been capable of designing the claimed device. However, the
 patentability question is not whether such an engineer
 would be capable of designing the instrument of the ’379
 patent. The patentability question is whether the prior art
 teaches or suggests the structure of the ’379 instrument as
 a whole. Although the court finds that it would have been
 obvious to combine the Solyntjes and Green reference
Case: 21-1995    Document: 42     Page: 11     Filed: 05/23/2022

 2                    ETHICON LLC   v. INTUITIVE SURGICAL, INC.

 mechanisms, it is not disputed that the Solyntjes’ spring-
 and-pin mechanism is not a spent-cartridge lockout, and
 that a simple combination does not produce the ’379 instru-
 ment.
     There is no teaching or suggestion in the prior art of
 the ’379 patent’s structure as a whole, although the prior
 art shows closely related surgical instruments. No refer-
 ence shows or suggests a spring-and-pin lockout within the
 jaws of an endoscopic cutting and stapling instrument.
 And the inventors’ description in the ’379 specification of
 the problem to be solved is not prior art against their solu-
 tion. Although my colleagues now find it obvious to make
 the ’379 instrument, no one did so despite the advantages
 and benefits here achieved.
      The ’379 instrument has advantages and benefits not
 possessed by prior endoscopic instruments. Such an
 achievement is of particular relevance in the field of medi-
 cal technology, where afflicted patients may be benefitted
 by any technological advantage. Such opportunity for ben-
 efit is a purpose of the patent system, thereby serving the
 public interest. The purpose of encouraging development
 of new technology warrants recognition of the varied attrib-
 utes of the myriad fields of technological ecommerce.
     The panel majority finds the elements of the ’379 in-
 vention in assorted prior art references, which the majority
 then plugs into the claims. Such judicial hindsight was ne-
 gated in KSR International, where the Supreme Court ob-
 served that “inventions in most, if not all, instances rely
 upon building blocks long since uncovered, and claimed dis-
 coveries almost of necessity will be combinations of what,
 in some sense, is already known.” KSR Int’l Co. v. Teleflex
 Inc., 550 U.S. 398, 418–19 (2007).
     From my colleagues’ analysis and conclusion, I re-
 spectfully dissent.