“Noting that the specification passages made ‘it unreasonable to read the ‘sized and shaped for insertion’ claim language as covering an artificial valve fitted for the space left after removing the native valve,’ the Federal Circuit concluded that the claims were not anticipated.”
On October 15, the United States Court of Appeals for the Federal Circuit (CAFC), in St. Jude Medical, LLC v. Snyders Heart Valve LLC, affirmed an inter partes review (IPR) decision of the United States Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (the Board) rejecting St. Jude Medical, LLC’s (St. Jude) contention that Snyders Heart Valve LLC’s (Snyders) artificial heart valve patent was invalid. The CAFC also reviewed a second IPR decision, wherein it reversed the Board’s decision that certain claims of the patent were invalid and affirmed the Board’s decision that the remaining claims were valid.
Inter Partes Review Proceedings
In 2017, St. Jude filed two IPR petitions with the Board, requesting review of claims 1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30 of U.S. Patent No. 6,540,782 (the ‘782 patent), which was owned by Snyders, and directed to an artificial heart valve and a system for inserting the valve. The Board instituted two reviews, each addressing all the challenged claims. In IPR2018-00105 (IPR-105), the Board ruled that St. Jude had failed to establish unpatentability of any of the challenged claims. In IPR2018-00106 (IPR-106), the Board found that claims 1, 2, 6, and 8 were anticipated by U.S. Patent No. 5,855,601 to Bessler but found that St. Jude’s failed to establish unpatentability as to all other claims. St. Jude appealed to the CAFC, arguing that in IPR-105, the Board erroneously rejected the position that U.S. Patent No. 5,957,949 to Leonhardt anticipated claims 1, 2, 4–8, and 28. With respect to IPR-106, St. Jude argued that the Board erroneously rejected the argument that Bessler anticipated claim 28 and in rejecting St. Jude’s challenge to most of the claims at issue as being obvious over Bessler in view of U.S. Patent No. 4,339, 831 to Johnson and U.S. Patent No. 5,413,599 to Imachi. Snyders cross- appealed the Board’s decision in IPR-106, asserting that the Board erred in finding that claims 1, 2, 6, and 8 were anticipated by Bessler.
With respect to IPR-105, the CAFC explained that the sole issue on appeal was whether the Board erred in rejecting St. Jude’s contention that claims 1, 2, 4–8, and 28 were anticipated by Leonhardt and the sole error alleged by St. Jude was that the Board rejected St. Jude’s assertion that Leonhardt disclosed a “band,” as required by the claims. During the IPR, the Board adopted St. Jude’s proposal for the claim construction of the term “band,” “except for making one small change that broadened, rather than narrowed, St. Jude’s proposal.” In particular, St. Jude proposed that “band” be construed to mean “[a] structure generally in the shape of a circular strip or ring; a band can be integrated with the frame,” but the Board rejected the “can be integrated with the frame” language and substituted the term “circular” with “closed.” In concluding that the Leonhardt graft material did not qualify because, “like a sleeve, it extend[ed] in width … over the entire structure it wraps around,” the Board relied on the terms “strip” and “ring” which came directly from St. Jude. The CAFC explained that St. Jude offered nothing indicate that “strip” and “ring” cannot have any width. Thus, the CAFC rejected St. Jude’s challenge to the decision in IPR-105 and affirmed the Board’s decision that the claims were not anticipated by Leonhardt.
In reviewing Snyders’ cross-appealed of Board’s finding that Bessler anticipated claims 1, 2, 6, and 8, the CAFC agreed with Snyders that the Board’s erred in construing the “sized and shaped” limitation and that Bessler does not anticipate claims 1, 2, 6, and 8. The CAFC noted that [c]laim 1 of the ’782 patent recited an “artificial heart valve for repairing 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 downstream region.” The CAFC also noted that the requirement that the frame be “sized and shaped” a certain way, as recited in the claim, suggested “a focus on how the frame is fitted to the surrounding material (which depends on whether the native valve remains), a focus that goes beyond mere linear ‘position’ between two regions.” The CAFC also referred to passages in the specification of the ‘782 patent that indicated that “sized and shaped” referred to fitting the valve between the cusps of an intact native heart valve. Noting that the specification passages made “it unreasonable to read the ‘sized and shaped for insertion’ claim language as covering an artificial valve fitted for the space left after removing the native valve,” the CAFC concluded that the claims were not anticipated by Bessler on the record of IPR-106 and reversed the Board’s decision with respect to claims 1, 2, 6 and 8.
The CAFC also considered St. Jude’s argument that the Board erred in rejecting its argument with respect to the obviousness of the remaining claims of the ’782 patent over Bessler, Johnson, and Imachi. In the IPR, the “Board found that St. Jude failed to prove that a relevant artisan would have made the particular combination St. Jude proposed—retaining the ‘cuff’ from Bessler … to provide the ‘band’ required by the claims at issue.” The CAFC rejected St. Jude’s challenge, noting that St. Jude did not demonstrate that the Board was unreasonable in determining that “St. Jude did not adequately or persuasively establish the motivation to make the particular combination it proposed in arguing obviousness.” Thus, the CAFC affirmed the Board’s decision that the claims were not obviousness over the applied prior art in IPR-106.