Snyders Heart Valve LLC v. St. Jude Medical, LLC ( 2021 )

Case: 19-2111 Document: 79 Page: 1 Filed: 10/05/2021
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
SNYDERS HEART VALVE LLC,
Appellant
v.
ST. JUDE MEDICAL, LLC,
Appellee
UNITED STATES,
Intervenor
______________________
2019-2111
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2018-
00107.
______________________
Decided: October 5, 2021
______________________
MATTHEW JAMES ANTONELLI, Antonelli, Harrington &
Thompson, LLP, Houston, TX, for appellant. Also repre-
sented by ZACHARIAH HARRINGTON, LARRY D. THOMPSON,
JR.; SARAH RING, Daniels & Tredennick, Houston, TX.
JOHN C. O'QUINN, Kirkland & Ellis LLP, Washington,
DC, for appellee. Also represented by HANNAH LAUREN
Case: 19-2111 Document: 79 Page: 2 Filed: 10/05/2021
2 SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC
BEDARD, JASON M. WILCOX; BRYAN SCOTT HALES, KRISTINA
NICOLE HENDRICKS, Chicago, IL.
MELISSA N. PATTERSON, Appellate Staff, Civil Division,
United States Department of Justice, Washington, DC, for
intervenor. Also represented by JEFFREY B. CLARK,
COURTNEY DIXON, SCOTT R. MCINTOSH; THOMAS W.
KRAUSE, ROBERT MCBRIDE, FARHEENA YASMEEN RASHEED,
Office of the Solicitor, United States Patent and Trade-
mark Office, Alexandria, VA.
______________________
Before NEWMAN, O’MALLEY, and TARANTO, Circuit Judges.
O’MALLEY, Circuit Judge.
This is the second time we have considered this appeal.
We previously vacated and remanded the inter partes re-
view (“IPR”) at issue in this appeal for rehearing by the Pa-
tent Trial and Appeal Board (“Board”) pursuant to our
opinion in Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d
1320 (Fed. Cir. 2019). Snyders Heart Valve LLC v. St. Jude
Med., LLC, 825 F. App’x 888 (Fed. Cir. 2020), cert. granted,
judgment vacated sub nom. Iancu v. Fall Line Pats., No.
20-853, 2021 WL 2637823 (U.S. June 28, 2021). In that
opinion, we reached only Snyders Heart Valve LLC’s
(“Snyders”) arguments under the Appointments Clause.
We did not address the merits of the Board’s decision. The
United States of America, which intervened in the appeal,
sought certiorari to challenge our remand. After its deci-
sion in United States v. Arthrex, Inc., 141 S. Ct. 1970(2021), the Supreme Court vacated and remanded the mat-
ter to us for reconsideration in light of its decision. Iancu,
2021 WL 2637823. On remand, Snyders waives its Ap-
pointments Clause challenge and asks that we address its
appeal on the merits. We do so and reverse the Board’s de-
termination that the challenged claims are unpatentable
because that finding rests on an erroneous claim construc-
tion.
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SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC 3
I. BACKGROUND
In October 2016, Snyders sued St. Jude Medical, LLC
(“St. Jude”) in the Eastern District of Texas. It alleged that
St. Jude had infringed two patents directed to “artificial
heart valves for repairing damaged heart valves”: U.S. Pa-
tent No. 6,540,782 and U.S. Patent No. 6,821,297. ’782 pa-
tent, col. 1 ll. 15–16; ’297 patent, col. 1 ll. 15–16. In October
2017, St. Jude filed four IPR petitions challenging claims
of the two patents.
At issue in this appeal is IPR2018-00107 (“IPR-107”),
in which St. Jude challenged claims 1–3, 8, 9, 22, 23, 31–35,
37–39, and 45 of the ’297 patent. The key prior art in this
appeal is U.S. Patent No. 5,855,601 (“Bessler”). Bessler dis-
closes an artificial heart valve and a method and device for
installing that valve. ’601 patent, col. 2 ll. 55–67.
In its final written decision in IPR-107, the Board
found all challenged claims of the ’297 patent unpatentable
as either anticipated by Bessler or obvious over Bessler in
combination with other prior art references. St. Jude Med.,
LLC v. Snyders Heart Valve LLC, IPR2018-00107, 2019
WL 1978347 (P.T.A.B. May 2, 2019). Snyders appealed to
this court. In its appeal, it raised, inter alia, an Appoint-
ments Clause challenge and challenges to the Board’s final
written decision on the merits. We vacated the Board’s de-
cision and remanded for a new hearing in compliance with
this court’s decision in Arthrex. The United States peti-
tioned the Supreme Court for a writ of certiorari. After the
Supreme Court devised a new remedy for the Appoint-
ments Clause violation in United States v. Arthrex, Inc.,
141 S. Ct. 1970 (2021), it granted the United States’ peti-
tion, vacated, and remanded to this court for further con-
sideration in light of its Arthrex decision.
In other cases where we have received similar remands
from the Supreme Court, we have remanded to the Patent
Office for the Director to review the Board’s decision. But,
in this case, all parties agree that Snyders has waived its
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4 SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC
Appointments Clause challenge and that remand to the Pa-
tent Office for Director review is not proper. Snyders ar-
gues that we should reverse the Board’s unpatentability
decision on the merits in light of our intervening decision
reversing portions of the Board’s decision in one of the ’782
patent IPR proceedings. St. Jude contends that reversal is
not appropriate and that we should, instead, remand to the
Board for reconsideration in light of our intervening deci-
sion concerning the ’782 patent.
We agree with Snyders’ argument and find that, on this
record, reversal is the appropriate course of action. For the
same reasons that we reversed the Board’s unpatentability
decisions as to claims 1, 2, 6, and 8 in the ’782 patent IPR
proceedings, we reverse the Board’s unpatentability deci-
sions as to claims 1–3, 8, 9, 22, 23, 31–35, 37–39, and 45 of
the ’297 patent.
The ’782 Patent IPR Proceedings
In IPR2018-00106 (“IPR-106”), the Board ruled that St.
Jude had shown by a preponderance of the evidence that
claims 1, 2, 6, and 8 of the ’782 patent were unpatentable
but had failed to establish unpatentability of all other chal-
lenged claims. St. Jude Med., LLC v. Snyders Heart Valve
LLC, IPR2018-00106, 2019 WL 1975349 (P.T.A.B. May 2,
2019). St. Jude appealed some of the Board’s findings and
Snyders cross-appealed the Board’s unpatentability find-
ings as to claims 1, 2, 6, and 8. We affirmed the Board’s
findings that certain claims were not shown unpatentable
but reversed the Board’s finding that claims 1, 2, 6, and 8
are unpatentable. St. Jude Med., LLC v. Snyders Heart
Valve LLC, 977 F.3d 1232 (Fed. Cir. 2020). Our opinion as
to claims 1, 2, 6, and 8 focused on the limitation “a flexibly
resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region,”
and, particularly, the “sized and shaped” requirement. We
held that the Board erred in construing the “sized and
shaped” limitation of ’782 patent claim 1. Id. at 1240. We
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SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC 5
reversed the Board’s finding that Bessler anticipated
claims 1, 2, 6, and 8 because it was based on the Board’s
erroneous construction of the “sized and shaped” limitation
and because St. Jude had not preserved any argument that
Bessler disclosed the “sized and shaped” limitation as
properly construed. Id. at 1242.
The Board did not expressly construe the “sized and
shaped” limitation in IPR-106. But, in finding that Bessler
anticipated claims 1, 2, 6, and 8, it determined that “[t]he
claim language does not require the frame be sized and
shaped for insertion into a damaged heart valve,” but “only
that the frame is sized and shaped for insertion in a posi-
tion between the upstream region and the downstream re-
gion.” St. Jude, 2019 WL 1975349 at *9. The Board
rejected Snyders’ argument that Bessler could not read on
the limitation because Bessler’s valve is inserted in a
“much larger space left following the excision and removal
of a damaged heart valve.” Id. Thus, the Board concluded,
Bessler satisfied the claim 1 limitation of a “frame sized
and shaped for insertion between the upstream region and
the downstream region.” Id. at *9.
On appeal, Snyders argued that the Board’s construc-
tion was incorrect because it covers frames sized and
shaped for installation with the native valve removed, ra-
ther than only with the native valve in place. We agreed.
We found support for Snyders’ construction in the lan-
guage of the ’782 claims and written description. Claim 1
of the ’782 patent recites an “artificial heart valve for re-
pairing a damaged heart valve having a plurality of cusps,
separating an upstream region from a downstream region
. . . comprising . . . a flexibly resilient frame sized and
shaped for insertion between the upstream region and the
downstream region.” ’782 patent, col. 10 ll. 22–27. We
found that “[t]he requirement that the frame be ‘sized and
shaped’ a certain way suggests a focus on how the frame is
fitted to the surrounding material (which depends on
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6 SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC
whether the native valve remains), a focus that goes be-
yond mere ‘linear’ position between two regions[.]” St.
Jude, 977 F.3d at 1240. We also found that the Board’s
construction would render claim 1’s reference to the dam-
aged heart valve “having a plurality of cusps” superfluous
because it would include instances where the damaged
heart valve and its cusps are removed. Id. at 1240–41.
We then found evidence in the ’782 specification that
“resolves the interpretive question” under the applicable
broadest reasonable interpretation standard. 1 Id. The ’782
specification states that “the frame is sized and shaped for
insertion between the plurality of cusps C of the damaged
heart valve in a position between an upstream region and
a downstream region.” ’782 patent, col. 5 ll. 48–51 (empha-
sis added). We found that this language “indicates that
‘sized and shaped’ is not meant to refer only to placement
in a position between the upstream and downstream re-
gions, but also to fitting between the cusps of the intact na-
tive valve.” St. Jude, 977 F.3d at 1241. The specification
also stresses that the claimed artificial heart valve can be
inserted without removing the native valve—an improve-
ment over prior art heart valves. See ’782 patent, col. 1 ll.
37–42 (‘‘[M]any [previous] valves also require the damaged
native heart valve to be removed prior to implanting the
artificial valve.’’); id., col. 1 ll. 40–42 (‘‘Removing the native
valve increases the risk that a portion of the valve will mi-
grate through the body and block vessels downstream from
the heart.’’); id., col. 2 ll. 21–25 (‘‘Among the several objects
and features of the present invention may be noted the
1 Challenged claims in IPR petitions filed prior to
November 13, 2018 are construed under the broadest rea-
sonable interpretation standard. 37 C.F.R. § 42.100(b)
(2016); St. Jude, 977 F.3d at 1238 n.3. IPR-106 and IPR-107
were both filed in 2017, so the broadest reasonable interpre-
tation standard applies.
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SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC 7
provision of an artificial heart valve which accommodates
implantation without removing the damaged native heart
valve . . . .’’). Finally, the specification states that the
Bessler heart valve poses problems which the claimed
valve overcomes because the procedure disclosed in Bessler
includes invasive “excision, vacuum removal of the native
valve, cardiopulmonary bypass and backflushing of the cor-
onary arterial tree.’’ Id., col. 2 ll. 14–20 (emphasis added).
We concluded that these specification passages “make it
unreasonable to read the ‘sized and shaped for insertion’
claim language as covering an artificial valve fitted for the
place left after removing the native valve.” St. Jude, 977
F.3d at 1241.
II. DISCUSSION
A. Similarities Between the ’782 and ’297 Patents
St. Jude asks that we remand IPR-107 to the Board ra-
ther than outright reverse the Board’s unpatentability
finding because of differences between the ’782 and ’297
patents. We disagree. The claims and written descriptions
in the two patents are the same in all relevant respects.
Thus, our claim construction holding concerning the ’782
patent’s “sized and shaped” limitation forecloses a different
construction for the “sized and shaped” limitation in the
’297 patent.
All challenged claims of the ’297 patent, like claims 1,
2, 6, and 8 of the ’782 patent, require an “artificial heart
valve for repairing a damaged heart valve having a plural-
ity of cusps separating an upstream region from a down-
stream region . . . comprising . . . a flexibly resilient frame
sized and shaped for insertion between the upstream re-
gion and the downstream region.” Compare ’782 patent,
col. 10 ll. 22–27, with ’297 patent col. 19 ll. 11–16.
The two patents have similar, but not identical, written
descriptions. But all portions of the ’782 written descrip-
tion which we found “resolve[] the interpretive question” of
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8 SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC
the proper construction of the “sized and shaped” limitation
appear in the ’297 patent’s written description. Compare
’782 patent, col. 5 ll. 48–51, with ’297 patent, col. 6 ll. 30–32
(“[T]he frame 20 is sized and shaped for insertion between
the plurality of cusps C of the damaged heart valve in a
position between an upstream region and a downstream re-
gion.”); compare ’782 patent, col. 1 ll. 37– 42, with ’297 pa-
tent, col. 1 ll. 41–43 (‘‘[M]any [previous] valves also require
the damaged native heart valve to be removed prior to im-
planting the artificial valve.’’); compare ’782 patent, col. 1
ll. 40–42, with ’297 patent, col. 1 ll. 43–46 (‘‘Removing the
native valve increases the risk that a portion of the valve
will migrate through the body and block vessels down-
stream from the heart.’’); compare ’782 patent, col. 2 ll.
21–25, with ’297 patent, col. 2 ll. 26–29 (‘‘Among the several
objects and features of the present invention may be noted
the provision of an artificial heart valve which accommo-
dates implantation without removing the damaged native
heart valve . . . .’’); compare ’782 patent, col. 2 ll. 14–20,
with ’297 patent, col. 2 ll. 20–23 (“The Bessler procedure
includes excision, vacuum removal of the native valve, car-
diopulmonary bypass and backflushing of the coronary ar-
terial tree.’’).
Based on these similarities between the ’782 and ’297
patents, we hold that, in the ’297 patent, just as in the ’782
patent, it is “unreasonable to read the ‘sized and shaped
for insertion’ claim language as covering an artificial valve
fitted for the place left after removing the native valve.”
See St. Jude, 977 F.3d at 1241.
B. Similarities Between IPR-106 and IPR-107
St. Jude asks that we remand IPR-107 to the Board ra-
ther than reverse the Board’s unpatentability finding be-
cause of differences between IPR-106 and IPR-107. St.
Jude avers that, in IPR-107, unlike in IPR-106, it argued
that it would have been obvious to reduce Bessler’s size and
that a second reference, U.S. Patent No. 4,339,831Case: 19-2111 Document: 79 Page: 9 Filed: 10/05/2021
SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC 9
(“Johnson”), taught the “sized and shaped” limitation. St.
Jude argues that the Board has not yet addressed those ar-
guments and that it should be given the opportunity to do
so. We disagree. We have reviewed St. Jude’s filings in
IPR-107, and, just as we found in our review of IPR-106,
“St. Jude relied only on its claim-construction argument
that the [] claims cover the situation of a removed native
valve; it did not dispute the express assertion by Snyders
that Bessler ‘requires removal of the native heart valve.’”
See St. Jude, 977 F.3d at 1241 (quoting St. Jude, 2019 WL
1975349 at *9). Thus, here, as there, “St. Jude therefore
has not preserved any argument that Bessler taught a non-
removal alternative that satisfied the ‘sized and shaped’
limitation.” See id. at 1241–42.
The two purportedly different invalidity arguments St.
Jude identifies are unhelpful to its cause. These argu-
ments are either based on the rejected claim construction
or are directed to limitations other than the “sized and
shaped” limitation.
Although St. Jude submits that it presented a theory of
obviousness over Bessler, review of the record reveals that
St. Jude’s only obviousness theories involving Bessler are
directed to limitations other than the “sized and shaped”
limitation. St. Jude never argued that it would be obvious
to modify Bessler to fit within a native valve rather than to
replace a native valve. In its petition, in a section about
the obviousness of all challenged claims over Bessler, but
not directed to any specific limitations, St. Jude stated: “In
this case, given Bessler’s use of the same types of compo-
nents, organized and operating in the same way as
claimed, and in view of the breadth of these claims, minor
modifications to the stent and the [flexible valve element]
as Defined to achieve predictable improvements is the ap-
plication of routine engineering, characteristic of obvious-
ness; nothing more.” Petition at 49, St. Jude Med., LLC v.
Snyders Heart Valve LLC, IPR2018-00107, Paper No. 3.
St. Jude went on to address other limitations specifically
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10 SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC
but did not address the “sized and shaped” limitation or
whether Bessler could be modified for implantation with-
out removal of the native valve. Id. In its Petitioner’s Re-
ply, St. Jude merely reiterated those vague arguments.
Petitioner’s Reply to Patent Owner’s Response at 11–12,
St. Jude Med., LLC v. Snyders Heart Valve LLC, IPR2018-
00107, Paper No. 38. In its Petitioner’s Reply, St. Jude also
asserted that a skilled artisan would have been motivated
to combine the Bessler valve with aspects of a valve dis-
closed by Johnson, despite Snyders’ argument that such a
combination would create a valve that was too large for
transluminal 2 delivery. Id. at 16. St. Jude argued that a
skilled artisan would know that “achieving collapsibility to
a desired size was a matter of routine engineering.” Id.
But this argument was not directed to the “sized and
shaped” limitation. It was directed to a separate limita-
tion—claim 37’s requirement of an included “vascular cath-
eter.” St. Jude never argued that a skilled artisan would
modify Bessler to meet the “sized and shaped” limitation
as properly construed.
Similarly, St. Jude submits that it cited Johnson for the
“sized and shaped” limitation, but review of the record re-
veals that St. Jude’s only unpatentability theory involving
Johnson is an obviousness combination with Bessler in
which St. Jude proposed inserting the valve structure of
Johnson into the outer tubular structure of Bessler. Peti-
tion at 56, St. Jude, IPR2018-00107. In this proposed com-
bination, the tubular structure of Bessler, which is “sized
and shaped” to replace the native valve rather than sit
within the native valve, “performs its known function of
holding the entire structure within the anatomy.” Id.
Thus, St. Jude’s arguments regarding Johnson incorporate
2 “Transluminal” refers to passing through a lumen
of a blood vessel (i.e., vasculature). Petition at 37, St. Jude,
IPR2018-00107.
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SNYDERS HEART VALVE LLC v. ST. JUDE MEDICAL, LLC 11
the error of its arguments regarding Bessler—they fail to
meet the “sized and shaped” limitation as properly con-
strued. That St. Jude’s invalidity theory incorporating
Johnson suffers from the same flaw as its theories involv-
ing Bessler is confirmed by an argument St. Jude made in
its Petitioner’s Reply: “The Bessler and Johnson frames
are both individually sized and shaped for insertion in the
native valve annulus, as would be the combination.” Peti-
tioner’s Reply to Patent Owner’s Response at 17, St. Jude,
IPR2018-00107. St. Jude never argued that Johnson met
the “sized and shaped” limitation as properly construed.
III. CONCLUSION
We conclude that, as in St. Jude, 977 F.3d at 1242, our
rejection of the Board’s claim construction of “sized and
shaped for insertion” precludes an unpatentability finding
as to the challenged claims of the ’297 patent. St. Jude re-
lied only on its now rejected claim construction argument
before the Board. It never disputed Snyders’ assertion that
Bessler requires removal of the native valve before inser-
tion of its valve. Thus, St. Jude has not preserved any ar-
gument on which it might prevail. Accordingly, we reverse
the Board’s unpatentability finding with respect to claims
1–3, 8, 9, 22, 23, 31–35, 37–39, and 45 of the ’297 patent.
REVERSED