Snyders Heart Valve LLC v. St. Jude Medical S.C., Inc.

Background

Snyders Heart Valve LLC asserted that St. Jude Medical S.C. Inc., St. Jude Medical, Cardiology Division, Inc., and St. Jude Medical, LLC infringed two patents relating to artificial heart valves used in minimally invasive heart-valve replacement surgery. This opinion addressed claim construction—the court’s determination of the meaning and scope of patent-claim language—for the phrase “sized and shaped” in U.S. Patent No. 6,540,782.

The relevant claim describes an artificial valve with a flexibly resilient frame “sized and shaped for insertion in a position between the upstream region and the downstream region.” Snyders proposed construing that language to mean “fitted for insertion between the unremoved cusps of the damaged heart valve.” St. Jude proposed adding a dimensional exclusion: either “sized and shaped, but not frames 1.5 cm and larger in expanded diameter” or, alternatively, “sized and shaped, but not frames between 1.5–3.5 cm in expanded diameter.”

Federal Circuit Decision and Prosecution Disclaimer

St. Jude argued that the Federal Circuit’s earlier decision in parallel patentability proceedings required the court to adopt a size-based construction. The court rejected that argument. It explained that the Federal Circuit’s decision turned on whether the artificial valve was designed for insertion with the native valve removed or with the native valve remaining in place. The Federal Circuit did not discuss the valves’ measurements, centimeter ranges, or whether the prior-art valve was too large.

St. Jude also argued that Snyders’s statements during the patentability proceedings clearly disclaimed a construction that was not based on valve dimensions. The court explained that prosecution disclaimer—the rule preventing a patent owner from later reclaiming a meaning clearly given up during patent proceedings—applies only when the earlier statements clearly and unmistakably limited the claim’s meaning. The court found that Snyders’s earlier references to the “larger space” left after removal of the native valve could reasonably refer to the status of the native valve and the insertion space, rather than to specific dimensions. Snyders had not referred to the particular 1.5-centimeter threshold or the 1.5-to-3.5-centimeter range proposed by St. Jude.

Claim Construction

The court held that the claim language did not refer to valve-frame dimensions or limit the claim to frames smaller than 1.5 centimeters. It also found that St. Jude’s proposed dimensional limitation conflicted with the patent’s preferred embodiments, which described dimensions between 3 and 5 centimeters in some circumstances and between 2 and 3 centimeters in others. The court concluded that the proposed limitation would also invalidate dependent claims requiring frame diameters between 3 and 5 centimeters or between 2 and 3 centimeters.

The court therefore rejected St. Jude’s proposed construction and adopted Snyders’s construction because it matched the claim’s plain language, the patent’s specification, and the Federal Circuit’s binding interpretation. The final construction of “sized and shaped” was: “fitted for insertion between the unremoved cusps of the damaged heart valve.” The order did not determine infringement in this opinion.

Disposition

The court adopted the construction of the “sized and shaped” claim term stated in the memorandum opinion.