Snyders Heart Valve LLC v. St. Jude Medical, LLC

Opinion

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NOTE: This disposition is nonprecedential.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

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. Case: 19-2111 Document: 79 Page: 3 Filed: 10/05/2021

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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 Case: 19-2111 Document: 79 Page: 4 Filed: 10/05/2021

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 Case: 19-2111 Document: 79 Page: 5 Filed: 10/05/2021

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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 Case: 19-2111 Document: 79 Page: 6 Filed: 10/05/2021

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. Case: 19-2111 Document: 79 Page: 7 Filed: 10/05/2021

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 Case: 19-2111 Document: 79 Page: 8 Filed: 10/05/2021

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. 4,339,831 Case: 19-2111 Document: 79 Page: 9 Filed: 10/05/2021

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(“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 Case: 19-2111 Document: 79 Page: 10 Filed: 10/05/2021

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. Case: 19-2111 Document: 79 Page: 11 Filed: 10/05/2021

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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