CRITICALITY OF CLAIM CONSTRUCTION
| November 16, 2020
ST. JUDE MEDICAL, LLC, Appellant v. SNYDERS HEART VALVE LLC, Cross-Appellant UNITED STATES, Intervenor
October 15, 2020
Newman, O’Malley and Taranto (Opinion by Taranto)
This precedential decision illustrates the importance of claim construction, particularly in considering all terms of a proposed claim construction.
St. Jude filed two petitions for inter partes reviews of U.S Patent No. 6,540,782 owned by Snyders Heart Valve, LLC. The petitions were instituted as “IPR-105” and “IPR-106”. The ‘782 patent is directed to artificial heart valves. The key claim term in IPR-105 was a “band” whereas the key term in IPR-106 was a “manipulator.”
Standards of review are always important and worth noting. Anticipation is a question of fact in which the Board’s determination of what is taught in the prior art reviewed for substantial evidence. For obviousness, the ultimate determination is a legal one reviewed de novo, with underlying factual determinations reviewed for substantial evidence support. Claim construction under the broadest reasonable interpretation is a determination of law reviewed de novo where based on intrinsic evidence with any findings about facts based on extrinsic evidence reviewed for substantial evidence support.
IPR-105
The ‘782 patent describes an artificial heart valve that can be installed via catheter without invasive surgery. The artificial heart valve has three main components: a valve element, a frame, and a band. Independent claim 1 sets forth:
“a band attached to the frame limiting spacing between adjacent anchors of said plurality of peripheral anchors;”
IPR-105 was instituted on the basis that Leonhardt disclosed an artificial heart valve having three main components: a biological valve, a valve stent, and graft material. The graft material is made of low-porosity woven fabric which is arranged to surround the stent.
The Board had essentially adopted St. Jude’s proposed claim construction of the term “band” as “a structure generally in the shape of a closed strip or ring.” This construction was slightly broader than St. Jude’s originally proposed construction of “a structure generally in the shape of a circular strip or ring” to cover shapes including ovals for example. Nonetheless, the Board concluded that graft material of Leonhardt would not be considered a “band” under this claim construction since the graft material of Leonhardt covered the entire length of the stent like a sleeve, and therefore was not a “strip” or “ring.”
St. Jude argued that the Board had erred in not accepting that Leonhardt anticipated claims 1, 2, 4-8 and 28 on the basis that the graft material is a “band.” St. Jude argued that the Board failed to apply its own claim construction of “band” and instead applied a narrower construction. St. Jude argued that one of ordinary skill in the art would understand that there would be no width restriction on what is considered a “band” quoting a dictionary definition of “band” as a thin strip of flexible material used to encircle or bind one object or hold a number of objects.
The CAFC noted a fundamental problem with this argument in that it ignores the terms “strip” and “ring” which were accepted as part of the claim construction. If St. Jude wanted to argue that “band” should not have been limited to a “strip” or “ring’, it should have proposed a different claim construction.
IPR-106
In IPR-106, the Board concluded that St. Jude had proved that claims 1, 2, 6 and 8 were anticipated by Bessler, but that St. Jude failed to prove that Bessler disclosed a “manipulator” required by claim 28. Both St. Jude and Snyders challenged these conclusions.
Snyders challenged the finding of anticipation in regard to the Board’s claim construction of how the frame is “sized and shaped” as well as claim 1’s “attached” limitation. Snyders also challenged the finding that the cuff in Bessler satisfies the requirement of claim 1 that the band limits spacing between adjacent frame members. The CAFC agreed that the Board erred in construing the “sized and shaped” limitation and that Bessler would not anticipate.
Claim 1 requires a “frame sized and shaped for insertion between the upstream region and the downstream region.” The Board 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 position between the upstream region and the downstream region.” The Board did not dispute the express assertion by Snyders that Bessler requires removal of the native valve for installation of the replacement valve.
The CAFC pointed out that claim 1 requires “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” which provides support for Snyders’ assertion. The reference to “repairing” without removal suggests the native valve remains. The CAFC further highlighted the teachings of the specification for clarifying the broadest reasonable interpretation. The specification teaches:
“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.”
This language indicates that “sized and shaped” is not meant to refer only to placement but also to fitting between cusps of the intact native heart. The CAFC concluded that the specification went beyond stating a general preference for leaving the native valve intact to make it unreasonable to read “sized and shaped for insertion” as covering an artificial valve fitted for space after removing the native valve.
St. Jude had relied on its claim construction that the claims cover the situation of a removed native valve and did not dispute the express assertion by Snyders that Bessler requires removal of the native heart valve. As such, the CAFC concluded that Bessler does not anticipate and therefore reverses the Board.
St. Jude challenged the finding that claim 28 was not anticipated in regard to the term “manipulator.” The CAFC concluded that it did not need to address this argument because claim 28 contains the “sized and shaped” limitation noted above.
St. Jude also challenged the finding that St. Jude failed to establish obviousness. Although the Board agreed that prior art advanced by St. Jude could be combined, the Board found that the particular combination proposed by St. Jude would not result. The Board found no adequate or persuasive explanation why one of ordinary skill in the art would keep the “integral” cuff portion while replacing the leaflet portion to which it is attached.
Takeaways
Claim construction is critical. Make sure to understand all terms of a proposed claim construction before accepting.
When challenging an obviousness determination based on a combination of art, remember that even if it would be reasonable to combine the art, the combination may not result in the particular arrangement as claimed.
