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`NOTE: This disposition is nonprecedential.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.
`
`

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`Case: 22-2230 Document: 46 Page: 2 Filed: 03/21/2024
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`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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`Case: 22-2230 Document: 46 Page: 3 Filed: 03/21/2024
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`CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION
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`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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`Case: 22-2230 Document: 46 Page: 4 Filed: 03/21/2024
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`CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION
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`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
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`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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`CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION
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`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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`Case: 22-2230 Document: 46 Page: 7 Filed: 03/21/2024
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`CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION
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`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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`CARDIOVALVE LTD. v. EDWARDS LIFESCIENCES CORPORATION
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`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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`Case: 22-2230 Document: 46 Page: 9 Filed: 03/21/2024
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`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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`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
`
`