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NOTE: This disposition is nonprecedential.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