CAFC Reverses PTAB Win for St. Jude, Finding Snyders’ Heart Valve Claims Not Unpatentable

“The two purportedly different invalidity arguments St. Jude identifies are unhelpful to its cause. These arguments are either based on the rejected claim construction or are directed to limitations other than the ‘sized and shaped’ limitation.” – CAFC October 5, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed a decision by the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) that Snyders Heart Valve LLC’s (Snyders) patent claims for an artificial heart valve were unpatentable. The court said the PTAB relied on an erroneous claim construction.

The CAFC previously vacated and remanded the appeal after only reaching Snyders’ argument under the Appointments Clause following its decision in Arthrex, Inc. v. Smith & Nephew, Inc. The U.S. government sought certiorari to challenge the remand, and after its decision in United States v. Arthrex Inc. (U.S. Supreme Court, 2021), the Supreme Court vacated the decision of the CAFC and remanded the matter back. Snyders waived the Appointments Clause challenge and asked the CAFC to consider the merits of the case on remand.

Procedural Posture

In October 2016, Synders alleged that St. Jude Medical, LLC (St. Jude) infringed both U.S. Patent No. 6,540,782 (‘782 patent) and U.S. Patent No. 6,821,297 (‘297 patent) directed to “artificial heart valves for repairing damaged heart valves.” In response, St. Jude filed four inter partes review (IPR) petitions challenging various claims of the two patents.

The present appeal surrounds 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 PTAB held that all the challenged claims of the ‘297 patent were either anticipated by U.S. Patent 5,855,601 (‘601 patent) or the claims were obvious over the ‘601 patent in combination with other prior art references.

The CAFC acknowledged that in other cases where they received Arthrex remands from the Supreme Court, the court has typically remanded the appeal back to the Director to examine the PTAB’s decision. However, all parties agreed that Snyders had waived the Appointments Clause issue and that remand to the Director would not be proper, said the CAFC. Snyders argued that the PTAB’s unpatentability decision should be reversed based on one of the CAFC’s intervening decisions on the ‘782 patent, which reversed the decision of the PTAB. St. Jude contended that the appeal should be remanded to the PTAB based on the court’s decision regarding the ‘782 patent. The CAFC found that remand was improper and agreed with Snyders’ argument.

‘782 Patent IPR Results

The PTAB found that St. Jude had shown that some, but not all, of the claims challenged in the ‘782 patent were unpatentable in IPR2018-00106 (IPR-106). St. Jude appealed some of the findings by the PTAB, while Snyders cross-appealed the finding that four of the claims were unpatentable. The CAFC affirmed the finding that not all of the challenged claims were unpatentable, but reversed the ruling that four of the claims were unpatentable.

The CAFC held that the PTAB erred in their construction of the “sized and shaped” limitation of the ‘782 patent after focusing on the limitation, “a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and downstream region” of the ‘782 patent.

Additionally, the court reversed the PTAB’s decision that the ‘601 patent anticipated claims within the ‘782 patent. Based on Snyders’ arguments, the CAFC found that the basis of the PTAB’s erroneous construction of the “sized and shaped” limitation was sufficient to reverse their decision. Snyders argued the construction applied by the PTAB was incorrect because it covered frames sized and shaped for fitting with the native valve detached instead of only when the native valve is installed.

The CAFC found support for Snyders’ argument in the wording of the ‘782 patent claims and written description and the PTABs construction would render a reference in claim 1 to be superfluous. The court found the wording of claim 1 suggested a focus on the frames fitting to its surroundings which goes beyond simply linear position between two regions.

Under the broadest reasonable interpretation standard, the CAFC found evidence in the ‘782 specification which resolved the interpretative question. The language in the specification indicated that “sized and shaped” refers to both the placement of the valve and the valve can be inserted without removing the valve, which was an improvement over the prior art. The CAFC concluded their holding regarding the ‘782 patent by finding language in the specification which states improvements over the ‘601 patent.

Parallels between ‘782 and ‘297 Patents and Proceedings

The court disagreed with St. Jude’s logic that IPR-107 should be remanded back to the PTAB because the ‘782 patent and ‘297 patent are different. The CAFC held that the claims and written descriptions were the same in all relevant aspects of the two patents. Thus, the construction of the claims focused on the “sized and shaped” limitation should be interpreted similarly.

Following similar logic to their argument regarding the patents, St. Jude argued the CAFC should remand IPR-107 to the PTAB because of the differences between IPR-107 and IPR-106. St. Jude claimed that, unlike in IPR-106, in IPR-107 it would have been obvious to reduce the size disclosed in the ‘601 patent and that U.S. Patent 4,339,831 (‘831 patent) taught the “sized and shaped” limitation. Since the PTAB had not addressed these arguments, St. Jude argued they should be given the chance to address these arguments.

The CAFC examined both St. Jude’s arguments in the present case as well as the court’s decision in IPR-107. The court explained:

“The two purportedly different invalidity arguments St. Jude identifies are unhelpful to its cause. These arguments are either based on the rejected claim construction or are directed to limitations other than the ‘sized and shaped’ limitation.”

The court concluded their analysis by highlighting the flaws regarding St. Jude’s arguments of unpatentability through review of the record. St. Jude claimed they presented an argument of obviousness over the ’601 patent, however, the record showed this theory regarding the ‘601 patent was directed towards other limitations than the “sized and shaped” limitation. Citing St. Jude’s petition, the CAFC found that St. Jude did not address whether the ‘601 patent could be modified to operate without removing the native valve and continued to reiterate vague arguments in their reply.

St. Jude asserted that a skilled artisan would have been driven to combine the valve outlined in the ‘601 patent with similar aspects in the ‘831 patent. Snyder refuted this assertion, arguing that combining these two patents would result in a valve that would be too large for transluminal delivery. Addressing this claim by Snyder, St. Jude argued a skilled artisan would have knowledge that reaching the desired size would be a matter of predictable engineering. However, this argument was not directed to the “sized and shaped” limitation, which St. Jude never argued, according to the record.

St. Jude claimed that when addressing the “sized and shaped” limitation, they cited the ‘831 patent. The court found that the record only showed that St. Jude argued that a combination of the ’831 patent and ‘601 patent made the claims obvious and unpatentable. This combination would create a structure of the ‘601 patent which would perform its known function, meaning St. Jude’s argument failed to meet the court’s construction of the “sized and shaped” limitation. Accordingly, the PTAB’s decision was reversed as to the unpatentability findings.

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