Court Opinion

ID: 9953068
Source: CourtListenerOpinion
Date Created: 2024-03-21 15:03:00.061605+00
Date Added: 2024-06-11T14:45:37.683560
License: Public Domain

Case: 22-2230    Document: 46     Page: 1   Filed: 03/21/2024

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

                 CARDIOVALVE LTD.,
                      Appellant

                             v.

     EDWARDS LIFESCIENCES CORPORATION,
         EDWARDS LIFESCIENCES LLC,
                    Appellees
             ______________________

                        2022-2230
                  ______________________

     Appeal from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in No. IPR2021-
 00383.
                  ______________________

                 Decided: March 21, 2024
                 ______________________

     SARA TONNIES HORTON, Willkie Farr & Gallagher LLP,
 Chicago, IL, argued for appellant. Also represented by
 DEVON WESLEY EDWARDS, New York, NY; DAVID PHILLIP
 EMERY, WILLIAM MANDIR, Sughrue Mion, PLLC, Washing-
 ton, DC.

    JOSHUA STOWELL, Knobbe, Martens, Olson & Bear,
 LLP, Irvine, CA, argued for appellees. Also represented by
 BRIAN C. BARNES, CRAIG S. SUMMERS.
Case: 22-2230     Document: 46      Page: 2     Filed: 03/21/2024

 2   CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION

                   ______________________

     Before TARANTO, CHEN, and STOLL, Circuit Judges.
 TARANTO, Circuit Judge.
     Cardiovalve Ltd. owns U.S. Patent No. 10,226,341, ti-
 tled “Implant for Heart Valve.” Edwards Lifesciences Cor-
 poration and Edwards Lifesciences LLC (collectively,
 Edwards) successfully petitioned the Patent and Trade-
 mark Office (PTO) to institute an inter partes review of
 claims 1–3, 5, 6, 8–11, and 13–21 of the ʼ341 patent under
 35 U.S.C. §§ 311–19. After review, the PTO’s Patent Trial
 and Appeal Board determined in relevant part that all of
 the challenged claims were unpatentable for obviousness
 over U.S. Patent No. 7,635,329 (Goldfarb). Edwards
 Lifesciences Corp. v. Cardiovalve Ltd., No. IPR2021-00383,
 2022 WL 2812478, at *40 (P.T.A.B. July 18, 2022) (Board
 Decision). Cardiovalve appeals. We have jurisdiction un-
 der 28 U.S.C. § 1295(a)(4)(A). We affirm.
                                I
      The ʼ341 patent describes, with a particular focus on
 heart valves, “a prosthetic valve support . . . for facilitating
 minimally invasive (e.g., transcatheter and/or translu-
 minal) implantation of a prosthetic valve at a native valve
 of a subject.” ʼ341 patent, col. 1, lines 53–56; see also id.,
 col. 1, lines 31–34. Independent claim 1, which the parties
 agree is representative, recites:
     1. Apparatus for use at a native valve of a subject,
     the native valve including at least a first native
     leaflet and a second native leaflet, the apparatus
     comprising:
     an implant, comprising:
         an annular portion, being configured to
         be placed against an upstream side of the
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 CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION       3

        native valve, and having an inner perime-
        ter that defines an opening, and
        at least one leaflet clip:
            (i) coupled to the annular por-
            tion,
            (ii) comprising:
                at least two clip arms, movable
                with respect to each other to
                open and close the clip; and
                a clip-controller interface, the
                clip-controller interface being
                coupled to at least one of the
                clip arms, and
            (iii) configured:
                to be coupled to a portion of the
                first native leaflet by the clip
                arms being brought together to
                close around the first native
                leaflet,
                to be coupled to a portion of the
                second native leaflet by the clip
                arms being brought together to
                close around the second native
                leaflet, and
                to hold together the portion of
                the first leaflet and the portion
                of the second leaflet; and
    a delivery apparatus, configured to deliver the im-
    plant to the native valve, and comprising at least
    one clip controller, the at least one clip controller
    being reversibly couplable to the clip-controller in-
    terface, and configured to facilitate opening and
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 4   CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION

     closing of the clip, and the delivery apparatus being
     intracorporeally decouplable from the implant.
 Id., col. 27, lines 10–41 (emphases added).
     Goldfarb discloses, in one of its embodiments, a device
 for stabilizing heart valve leaflets. Goldfarb, col. 17, lines
 20–22. Figure 9B of Goldfarb illustrates this device, which
 is being inserted from above, so that upper is proximal and
 lower is distal from the inserter’s perspective:

 Id., fig.9B. The disclosed fixation device, 14, includes two
 proximal elements, 16, and two distal elements, 18, config-
 ured such that a proximal and distal element pair, when
 brought together, form a clip that grasps a heart valve leaf-
 let, LF, from the top and bottom. Id., col. 17, lines 29–37.
 The fixation device also includes flaps, 104, which restrict
 upward motion of the leaflets to better enable the proximal
 and distal elements to grasp the leaflets. Id., col. 17, lines
 38–50. Additionally, Goldfarb discloses that “[o]nce the
 leaflets have been grasped, the flaps . . . may be removed
 . . . or may be left behind to assist in holding the leaflets.”
 Id., col. 17, lines 51–53 (emphasis added).
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 CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION         5

     Cardiovalve does not dispute that Goldfarb discloses
 every limitation of the claims of the ʼ341 patent other than
 the requirement that the implant comprise “at least one
 leaflet clip” “coupled to the annular portion.” Further, Car-
 diovalve accepts that each of Goldfarb’s pairs of proximal
 and distal elements constitutes a “leaflet clip,” that each of
 Goldfarb’s flaps constitutes or contains an “annular por-
 tion,” and that any direct or indirect attachment of Gold-
 farb’s proximal and distal elements to Goldfarb’s flaps is a
 “coupl[ing].” See Cardiovalve Opening Br. at 32–33, 38–47;
 see also Board Decision, at *18. The Board found that Gold-
 farb makes the disputed claim element obvious, id., at *16–
 20, and concluded that Edwards had established obvious-
 ness, id., at *21.
                               II
     On appeal, Cardiovalve’s only challenge is that the
 Board erred in determining that Edwards had shown that
 it would have been obvious to a relevant artisan to attach,
 either directly or indirectly, Goldfarb’s flaps to its proximal
 and distal elements. We reject this challenge.
     “Obviousness is a question of law based on underlying
 findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed.
 Cir. 2009). We decide obviousness de novo but review for
 substantial-evidence support the Board’s subsidiary fact
 findings, including the presence or absence of a motivation
 to combine or modify teachings in the prior art, the pres-
 ence or absence of a reasonable expectation of success, and
 the predictability of results from known methods. See PGS
 Geophysical AS v. Iancu, 891 F.3d 1354, 1363 (Fed. Cir.
 2018); In re Stepan Co., 868 F.3d 1342, 1345–46 (Fed. Cir.
 2017); Intelligent Bio-Systems, Inc. v. Illumina Cambridge
 Ltd., 821 F.3d 1359, 1366 (Fed. Cir. 2016); TriMed, Inc. v.
 Stryker Corp., 608 F.3d 1333, 1341 (Fed. Cir. 2010).
     The Board here invoked the passage in the Supreme
 Court’s opinion in KSR International Co. v. Teleflex Inc.
 that addresses proof of obviousness through a
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 6   CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION

 determination that a “combination” would have been “obvi-
 ous to try.” 550 U.S. 398, 421 (2007); Board Decision, at
 *17–19. The pertinent passage from KSR reads:
     When there is a design need or market pressure to
     solve a problem and there are a finite number of
     identified, predictable solutions, a [relevant arti-
     san] has good reason to pursue the known options
     within his or her technical grasp. If this leads to
     the anticipated success, it is likely the product not
     of innovation but of ordinary skill and common
     sense. In that instance the fact that a combination
     was obvious to try might show that it was obvious
     under § 103.
 KSR, 550 U.S. at 421. We conclude that the Board’s find-
 ings made under this paragraph have substantial-evidence
 support and that its determination of obviousness is not le-
 gally erroneous.
      Relying on Goldfarb’s statement that the flaps “may be
 left behind,” Goldfarb, col. 17, lines 51–53, the Board found
 that the flaps may be left behind, and it is not disputed that
 leaving the flaps behind would necessitate that they be at-
 tached to something fixed. Board Decision, at *18. We
 read the Board’s opinion also to find, and Cardiovalve does
 not dispute, that Goldfarb’s flaps, if left behind, must be
 attached either “(1) to the fixation device [implant] or (2) to
 the heart tissue.” Board Decision, at *18; see id., at *15
 (reciting Cardiovalve’s argument for heart-tissue fixation);
 Cardiovalve Opening Br. at 38–47. Whether or not the
 heart-tissue option might itself be divided into two types of
 tissue (heart wall, and heart-valve annulus), the result, the
 Board determined, was that a relevant artisan would know
 of a “finite number of predictable options.” Board Decision,
 at *19; see id., at *18–20; id., at *16 n.16 (“[W]e decide that,
 even assuming that one option for a [relevant artisan] was
 to attach the flaps to the heart wall, it would have also been
 obvious to attach the flaps to the fixation device as a
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 CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION        7

 predictable option out of a number of options.”). In fact, the
 Board added, it was actually simpler to attach the flaps to
 the implant device (in particular, though perhaps not only,
 to a “coupling member” 19 shown in Goldfarb)—which is
 attaching them to the clips indirectly. Id., at *18–19; see
 also id., at *23 (making that finding in the context of Claim
 11, which raises the same issue).
     The Board’s findings are supported by substantial evi-
 dence. Edwards’s expert explained with concrete reason-
 ing why a relevant artisan would know to attach the flaps
 to the implant device and why such attachment would be
 expected to succeed. See J.A. 1163–68 ¶¶ 77–83, 1637–41
 ¶¶ 15–21, 1644–46 ¶¶ 24–27, 1648–51 ¶¶ 31–34, 1656–63
 ¶¶ 40–50. On appeal, Cardiovalve has concededly not chal-
 lenged the Board’s finding of the relevant expectation of
 success. Oral Arg. at 35:53–36:03.
      Cardiovalve criticizes the Board’s invocation of the ob-
 vious-to-try passage from KSR, but we find the criticisms
 unpersuasive. See Board Decision, at *17–18. First, Car-
 diovalve argues that there was no “finite number of identi-
 fied, predictable solutions,” KSR, 550 U.S. at 421
 (emphasis added); Cardiovalve Opening Br. at 33–36, be-
 cause there are too many possibilities. The Board properly
 determined otherwise. The claims require coupling a leaf-
 let clip to an annular portion, undisputedly allow indirect
 coupling, and are indifferent to where on the device or with
 what specific means the connection between an annular
 portion and the device is made. ʼ341 patent, col. 27, lines
 13–19. The record readily supports placing possibly rele-
 vant heart tissue into two categories—the valve annulus
 and wall tissue. See J.A. 2099–105 ¶¶ 32–45, 2627–28
 ¶¶ 20–23, 1816–20; see also U.S. Patent No. 6,629,534 (St.
 Goar),      U.S.     Patent      Application     Publication
 No. 2003/0120340 (Liska), U.S. Patent Application Publi-
 cation No. 2006/0229708 (Powell); Board Decision, at *18.
 And as already noted, there was ample evidence for why a
 relevant artisan would have found it at least “simpler” to
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 8   CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION

 use the implant for the attachment. See Board Decision, at
 *19; J.A. 1656–63 ¶¶ 40–50, 1816–20. The device-attach-
 ment option would have been obvious, as the Board found,
 whether or not there were a small number of other options
 that were also obvious.
      Second, Cardiovalve argues that, in order to be a
 “known option[]” within the obvious-to-try passage of KSR,
 550 U.S. at 421, the option at issue must have been ex-
 pressed in prior art documents. Cardiovalve Opening Br.
 at 36–38. That proposed document requirement is no-
 where articulated in KSR, and adopting it would be incon-
 sistent with the Supreme Court’s rejection in KSR of a rigid
 demand for the steps in an obviousness analysis to be
 proved by prior-art documents, to the exclusion of the
 knowledge and skill of the relevant artisan. See KSR, 550
 U.S. at 418–22, 427. Nor, contrary to Cardiovalve’s asser-
 tions, does our precedent require such a documentary ba-
 sis. The fact that we relied on documents in the two cases
 Cardiovalve highlights, Uber Technologies and Bayer, does
 not mean that a documentary basis is required. Uber Tech-
 nologies, Inc. v. X One, Inc., 957 F.3d 1334, 1339–40 (Fed.
 Cir. 2020); Bayer Schering Pharma AG v. Barr Laborato-
 ries, Inc., 575 F.3d 1341, 1350 (Fed. Cir. 2009).
      Third, Cardiovalve makes the procedural argument
 that the Board’s invocation of KSR’s obvious-to-try para-
 graph impermissibly injected a new theory different from
 the one raised by the petition. Cardiovalve Opening Br. at
 48–54; see Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990,
 1001–02, 1008 (Fed. Cir. 2023). We reject this argument
 for setting aside the Board’s decision.
     The Board’s obvious-to-try analysis did not change the
 prior art, or the embodiments in the prior art, relied on.
 Edwards argued from the beginning that a relevant artisan
 would have found it obvious to attach Goldfarb’s flaps to its
 fixation device (and therefore indirectly to its proximal and
 distal elements), because the flaps, if left behind, had to be
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 CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION       9

 attached somewhere and this was an obvious location.
 Compare J.A. 174 (“[A] [relevant artisan] would have found
 it obvious to couple the flaps to the [proximal and distal
 elements] so that the entire apparatus could be detached
 and ‘left behind’ together.”), with Board Decision, at *20
 (“[A] [relevant artisan] would have found it obvious to have
 attached the flaps to the [proximal and distal elements] of
 [Goldfarb] . . . as a predictable option when choosing to
 leave the flaps behind.”). Edwards’s expert cited in his
 original declaration to such a method of attachment—via
 coupling member 19 shown in figure 3 of Goldfarb. J.A.
 1166 ¶ 81; see Goldfarb, fig.3. In response, Cardiovalve
 pointed to another solution to the attachment problem,
 namely, attachment to heart tissue (valve annulus or wall),
 and urged that a relevant artisan would have used that so-
 lution. See Board Decision, at *15, *16 (discussing Cardio-
 valve submissions). In its obvious-to-try analysis, the
 Board then said that it need not find that the solution ar-
 gued for by Edwards was the only obvious one, because it
 was enough that, even if Cardiovalve’s submissions about
 alternative attachment locations were to be accepted, the
 Edwards-urged solution was an obvious one among two or
 three a relevant artisan would have known.
     It is the essential point of the KSR passage relied on by
 the Board that, when a relevant artisan would have recog-
 nized a problem, a consideration of whether only a small
 number of solutions existed is a natural part of an evalua-
 tion of whether a patent-claimed solution would have been
 obvious. The Board’s undertaking such consideration here
 was therefore a legitimate exercise of its duty to evaluate
 whether Edwards was right or wrong about the position
 Edwards consistently maintained—that attachment to the
 implant would have been obvious. All the Board did was to
 credit that position even on the assumption that Cardio-
 valve was right that a relevant artisan would have found
 one or two alternatives obvious as well. See Board Deci-
 sion, at *16 n.16 (quoted supra). And Cardiovalve was
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 10 CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION

 given an ample opportunity, through supplemental brief-
 ing, to address this proposed conclusion before the Board
 eventually adopted it. J.A. 871, 885.
     In these circumstances, we see no procedural error on
 the Board’s part in using the obvious-to-try paragraph of
 KSR as it did. We note that Cardiovalve does not mean-
 ingfully challenge that use as incomplete for want of addi-
 tional analysis, after finding the preconditions laid out in
 that paragraph met, to move from the conclusion that the
 at-issue solution “likely” was or “might” have been obvious,
 KSR, 550 U.S. at 421, to a determination that it actually
 would have been obvious. In this regard, it is notable that
 the Board actually found reasons for a relevant artisan to
 choose the Edwards-urged solution over the alterna-
 tive(s)—at the least, greater simplicity. Board Decision, at
 *19, *23. In light of that factual finding, together with the
 unchallenged factual finding of predictability, moreover, it
 may well be that we could affirm the obviousness conclu-
 sion even apart from the obvious-to-try analysis. We need
 not so decide, however, because we are not persuaded that
 there is reversible error in the Board’s analysis.
                              III
     We have considered Cardiovalve’s additional argu-
 ments and find them unpersuasive. For the foregoing rea-
 sons, we affirm the Board’s decision.
                        AFFIRMED