Aortic Innovations LLC v. Edwards Lifesciences Corp

Authored by: Jeremy J. Gustrowsky

In a recent decision, the U.S. Court of Appeals for the Federal Circuit addressed a patent dispute between Aortic Innovations LLC and Edwards Lifesciences over innovative devices used in transcatheter aortic valve replacement—a minimally invasive procedure to treat diseased heart valves. Aortic accused Edwards’ SAPIEN 3 Ultra valve of infringing four related patents that describe prosthetic valves with specific frame designs. These patents focus on “dual-frame” structures, where an inner frame holds the valve leaflets and an outer frame provides support and sealing to prevent leaks. The core issue centered on how to interpret the term “outer frame” in the patent claims, which led to a stipulated non-infringement judgment in the lower court.

The disagreement boiled down to claim construction, a process where courts define key patent terms to determine their scope. Aortic argued that “outer frame” simply meant a frame positioned outside the inner one, allowing for broader coverage that could include Edwards’ balloon-expandable design. Edwards, however, contended that the patents redefined “outer frame” to specifically mean a “self-expanding frame”—one made from shape-memory material that naturally springs open after delivery via catheter, unlike balloon-expandable frames that require inflation to deploy. The district court in Delaware sided with Edwards, finding that the patent’s description treated “outer frame” and “self-expanding frame” as interchangeable, effectively acting as the inventor’s own dictionary definition.

The Federal Circuit agreed with this interpretation after a detailed review of the patent’s shared specification. The court noted that the document repeatedly used the terms synonymously when describing the relevant structures in both “dual-frame” and “serial-frame” embodiments, without ever suggesting an outer frame could lack self-expanding properties. For instance, the summary section explicitly described transcatheter valves as combining a balloon-expandable frame with a self-expanding one, implying this dual nature is essential across all versions. This consistent usage, the judges ruled, clearly limited the term’s meaning for someone skilled in the field, overriding its plain, everyday interpretation.

As a result, the appeals court affirmed the non-infringement ruling for three of the patents, as Edwards’ product uses only a single balloon-expandable frame without a self-expanding outer one. The fourth patent’s claims were canceled by the U.S. Patent and Trademark Office during the appeal, mooting that part of the case. This ruling underscores how the patent disclosure can narrow claim scope in some instances through implied definitions, potentially affecting future disputes thus emphasizing the importance of precise language in patent filings.