St. Jude Medical, LLC v. Snyders Heart Valve LLC (Fed. Cir. 2020)

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At least some of the judges on the Federal Circuit have been reported to have voiced some frustration regarding the number of appeals of decisions by the Patent Trial and Appeal Board that are on the Court's docket, particularly Board decisions in inter partes review.  There being little evidence that this trend will not continue, the Court recently rendered its decision of Board decisions in two related appeals, in St. Jude Medical, LLC v. Snyders Heart Valve LLC.

The matter arose in two inter partes review proceedings, wherein St. Jude challenged the claims of U.S. Patent No. 6,540,782, directed to an artificial heart valve and systems for introducing the valve.  More specifically, the '782 patent discloses and claims 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 asserts 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).

The relevant recitations regarding the system for installing the valve in independent claim recites:

an instrument including

a holder having a hollow interior sized for holding the artificial valve when the frame is in the collapsed configuration;

an elongate manipulator attached to the holder for manipulating the holder into position between the upstream region and the downstream region; and

an ejector mounted in the hollow interior of the holder for ejecting the artificial heart valve from the hollow interior of the holder into position between the upstream region and the downstream region.

(relevant claim limitations in italics).

The Board instituted both IPRs  In IPR-105, St. Jude asserted that the challenged claims (1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30) were unpatentable as anticipated by U.S. Patent No. 5,957,949 to Leonhardt or obvious over a combination of the '949 patent and the combination of U.S. Patent No. 4,339,831 to Johnson and U.S. Patent No. 5,413,599 to Imachi.  In IPR-106, St. Jude asserted that claims 1, 2, 6, and 28 were anticipated by U.S. Patent No. 5,855,601 to Bessler or obvious or a combination the '601 patent with the '831 and '599 patents.  (Another patent, to Anderson, asserted against the '782 patent in the IPR-105 proceeding was not considered in the Federal Circuit's opinion.)

The primary reference asserted in the IPR-105 proceeding, the '949 patent, taught artificial valves implanted by catheter into the heart or esophagus.  Its relevant components are "a biological valve, a valve stent, and graft material," the latter component comprising "'thin-walled biocompatible, flexible and expandable, low-porosity woven fabric' [that] is 'arranged to surround [the] stent.'"  The primary reference asserted in the IPR-106 proceeding, the '601 patent, disclosed an artificial heart valve that could be "compressed or expanded, and the installed unit include[d] a rigid stent member and a flexible valve member with a cuff portion."  Secondary references, the '831 patent, disclosed an artificial heart valve with a "durable and flexible membrane," and the '599 patent taught a medical valve apparatus that the opinion characterized as "not [being] the subject of substantial discussion" in the Federal Circuit's opinion.

In the IPR-105 proceeding, the Board held that St. Jude had not established that the challenged claims were anticipated by the '949 patent nor obvious over the combination of the '949 patent taken in light of the '831 patent and the '599 patent.  In the IPR-106 proceeding, the Board held that St. Jude had established that challenged claims 1, 2, 6, and 8 were anticipated by the '601 patent but rejected St. Jude's anticipation arguments with regard to claim 28 and their arguments for all claims regarding obviousness.  Specifically, the opinion identified the dispositive issue as the Board's construction of the claim element "band," as "a structure generally in the shape of a closed strip or ring," which the opinion characterized as "slightly broadening" St Jude's construction from "circular" to "closed."  Under its construction the Board held that St. Jude had not proven that the '949 patent disclosed a band because (according to St. Jude) in the '949 patent disclosure the band "covered the entire length of the frame, like a sleeve" and was accordingly not a "strip" or a "ring."  The Board held that St. Jude thus failed to bear its burden of showing anticipation by a preponderance of the evidence.  Each party filed their appeal on the issues decided against them by the Board.

In an opinion by Judge Taranto, joined by Judges Newman and O'Malley, the Federal Circuit affirmed the Board's decision in IPR-105 and reversed the decision that Bessler anticipated the '782 patent claims in IPR-106.  The Court also affirmed the Board's decision that the challenged claims in both IPRs were not obvious over the combination of asserted prior art.  The opinion identified the sole issue on appeal in IPR-105 to be the Board's claim construction of the term "band."  St Jude's construction of a "circular" band excluded, for example, oval shapes, and that the band disclosed in the '949 patent extended over the entire structure that was not claimed in the challenged '782 patent claims.  Moreover, the panel stated that the Board's conclusions were consistent with elements of its claim construction that St. Jude had either asserted or acquiesced to and specifically rejected St. Jude's argument on appeal referencing a dictionary definition for the word "band."  Nor, according to the panel, were these limitations disclosed in the specification of the '782 patent.  The opinion stated that "[t]he more fundamental problem with St. Jude's basis for its argument, however, is that it simply does not address the terms 'strip' and 'ring' [as components of the band] which St. Jude itself proposed and now accepts as the defining terms of the claim construction."  Under these circumstances the Court stated that "[t]he adopted claim construction governs" and under that construction the '949 patent does not anticipate the '782 patent's challenged claims.

Both parties appealed the Board's decision in IPR-106, Snyders on the grounds that the '601 patent anticipated claims 1, 2, 6, and 8 of the '782 patent and St. Jude on the ground that claim 28 of the '782 patent was not anticipated by the '601 patent.  Snyders argued that the Board had made three errors of claim construction, but the Federal Circuit's decision found that one of these was in error and was sufficient for the panel to reverse the Board's anticipation determination.  The construed term was "how the frame is sized and shaped," which Snyders 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 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 was 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 does 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.

Turning to St. Jude's grounds for appeal, the panel first addressed the argument that the Board had erred in not finding the '601 patent anticipated claim 28, directed to a system for inserting the claimed heart valve.  The panel rejected St. Jude's argument (related to whether the '601 patent disclosed the "manipulator" recited in claim 28 of the '782 patent) because "[c]laim 28 contains exactly the same 'sized and shaped' limitation for the valve as does claim 1, requiring a valve meeting that limitation (among others) in combination with an instrument used to install the valve."  Accordingly, claim 28 is not anticipated by the '601 patent for the same reason the Court held that claims 1, 2, 6, and 8 of the '782 patent were not, and affirmed the Board's decision on that basis.  The Court also rejected St. Jude's argument that the Board erred in not finding claims 1, 2, 6, 8, and 28 of the '782 patent invalid for obviousness over the asserted art.  The Court's basis for this decision was that the grounds for the Board's decision were a factual determination regarding "whether a skilled artisan would be motivated to make the proposed combination to arrive at the claimed invention."  And the panel held that St. Jude had not satisfied its burden to show that the Board did not have substantial evidence supporting its decision.  Because the Federal Circuit must give deference to factual determinations of the Board, unless an appellant can show a lack of substantial evidence, the Court affirmed the Board's decision that the cited references did not render obvious the challenged claims of the '782 patent.

The Court gave costs to Snyders.

St. Jude Medical, LLC v. Snyders Heart Valve LLC (Fed. Cir. 2020)
Panel: Circuit Judges Newman, O'Malley, and Taranto
Opinion by Circuit Judge Taranto

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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