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

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The Supreme Court's decision in United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021), at the end of its last term resulted in many cases with pending certiorari petitions that were based on Appointment Clause challenges to be remanded to the Federal Circuit, and many (if not most) of those were remanded back to the Patent Trial and Appeal Board. The decision handed down by the Federal Circuit on Tuesday in Snyders Heart Valve LLC v. St. Jude Medical, LLC is an exception, the Court considering the appeal on the merits and reversing the Board's determination that St. Jude had shown by a preponderance of the evidence that challenged claims 1–3, 8, 9, 22, 23, 31–35, 37–39, and 45 of U.S. Patent No. 6,821,297 were invalid as being either anticipated by U.S. Patent No. 5,855,601 to Bessler or obvious over the '601 patent "in combination with other prior art references."

This is the second appeal of several IPRs between the parties; in an earlier case, St. Jude Medical, LLC v. Snyders Heart Valve LLC (Fed. Cir. 2020), the Board found Snyders' U.S. Patent No. 6,540,782, directed to an artificial heart valve and systems for introducing the valve, to be neither anticipated over U.S. Patent No. 5,957,949 nor rendered obvious over a combination of the '949 patent with U.S. Patent No. 4,339,831 to Johnson and U.S. Patent No. 5,413,599 to Imachi. The Federal Circuit affirmed this decision. In the same appeal, the Federal Circuit reversed the Board's finding that certain of the challenged claims of the '782 patent were anticipated by the Bessler '601 patent based on erroneous claim construction.

In this case, the Court proceeded to a decision on the merits because "all parties agree[d] that Snyders ha[d] waived its Appointments Clause challenge and that remand to the Patent Office for Director review is not proper." But the parties differed, with Snyder asking the Court to reverse based on its decision in the earlier appeal and St. Jude asking that the case be remanded to the Board for its reconsideration in the first instance in view of the intervening Federal Circuit decision.

The Court agreed with Snyders and rendered a decision reversing the PTAB on the same basis that the Board's unpatentability decision was reversed in the earlier appeal, in a decision by Judge O'Malley joined by Judges Newman and Taranto (this was the same panel that heard the earlier appeal; there, Judge Taranto wrote the unanimous opinion). The panel reiterated in brief their reasons for reversing the Board in its earlier decision, which bears at least a synopsis here. According to that earlier opinion, the '782 patent disclosed and claimed an artificial heart valve that can be administered using a catheter (thereby forgoing open heart surgery) and can be placed without removing the patient's damaged valve. The opinion asserted that the claimed artificial valve has three components: "a valve element, a frame, and a band." System claims for introducing the valve recite components for installing the artificial valve comprising "a holder, a manipulator, and an ejector."

Claim 1 of the '782 patent is representative of the artificial heart valve claims at issue:

1. An artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, said artificial valve comprising:
a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream and the downstream region and a central portion located between the plurality of peripheral anchors;
a band attached to the frame limiting spacing between adjacent anchors of said plurality of peripheral anchors; and
a flexible valve element attached to the central portion of the frame and adjacent the band, said valve element being substantially free of connections to the frame except at the central portion of the frame and adjacent the band, said valve element having an upstream side facing said upstream region when the frame is anchored in the position between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored in the position between the upstream region and the downstream region, said valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the element permits downstream flow between said upstream region and said downstream region and a closed position in which the element blocks flow reversal from said downstream region to said upstream region, wherein the valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region [relevant claim limitations in italics].

Relevant to the Court's decision in this appeal, and with regard to the Board's decision on the second IPR challenging claims of the '782 patent, the Federal Circuit found error in the Board's construction of the term "how the frame is sized and shaped," which Snyders had argued was incorrect because "it covers frames sized and shaped for installation with the native valve removed, rather than only with the troubled native valve remaining in place." With regard to this limitation, the Board had found 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 position between the upstream region and the downstream region.'" This was error in the panel's view because the Board did not consider the further disclosure in the '601 patent that the native valve was required to be replaced, which the challenged '782 patent claims expressly did not require. The panel opinion found support for the argument that structural features of the claimed artificial valve were consistent with this lack of a requirement for native valve removal in the plain meaning of the claim language, as well as express disclosure to that effect in the '782 specification. Specifically, the specification disclosed 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" (emphasis in opinion). The significance for the Court was that this language indicated that the term "sized and shaped" "is not meant to refer only to placement in a position between the upstream and downstream regions, but also to fitting between the cusps of the intact native valve." This interpretation is consistent, according to the opinion, with further disclosure in the '782 specification of the benefit of not needing to remove the native heart valve as an improvement over the prior art and in particular the deficiencies in the '601 patent in this regard. Because the '601 patent did not meet the "size and shape" limitation as construed by the Federal Circuit, the panel reversed the Board's determination that the '782 patent claims were invalid for anticipation.

In this appeal, the Court rejected St. Jude's argument for remand that there were differences between the '782 and '297 patents relevant to the Court's decision. The opinion states that "[t]he claims and written descriptions in the two patents are the same in all relevant respects" and accordingly the Court's construction of the "sized and shaped" limitation in the claims of the '782 patent govern proper construction of the claims of the '297 patent at issue here. Even though the Court recognized that the written descriptions in the two specifications are not identical the Court asserted that "all portions of the '782 written description which we found 'resolve[] the interpretive question' of the proper construction of the 'sized and shaped' limitation appear in the '297 patent's written description." The Court dismissed St. Jude's other obviousness arguments as being "vague" or that they did not overcome Snyders' arguments to the contrary based on the structure of the replacement valves or that the arguments were directed to limitations other than the "sized and shaped" limitation that the Court considered dispositive. The panel concluded that:

[A]s in [the panel's earlier decision], 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 relied 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 insertion of its valve. Thus, St. Jude has not preserved any argument on which it might prevail.

On this basis the Federal Circuit reversed the Board invalidity findings.

Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2021)
Nonprecedential disposition
Panel: Circuit Judges Newman, O'Malley, and Taranto
Opinion by Circuit Judge O'Malley

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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