Intelectual Property (IP)

A&O Shearman

On September 16, 2024, the United States Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion vacating and remanding a decision from the District Court of Minnesota which held the asserted claims of medical patents to be indefinite.

Vascular Solutions LLC, Teleflex LLC, Arrow International LLC, and Teleflex Life Sciences LLC (collectively, “Teleflex”) own several patents directed to a “coaxial guide catheter that is deliverable through standard guide catheters by utilizing a guidewire rail segment to permit delivery without blocking use of the guide catheter.”

In July 2019, Teleflex sued Medtronic, Inc. and Medtronic Vascular, Inc. (collectively, “Medtronic”) for patent infringement, alleging that Medtronic’s guide-extension catheter telescope product infringes the claims of the asserted patents–which notably differ as to how they claim the catheter’s side opening. For instance, some claims include the side opening as part of the “substantially rigid portion/segment,” while others recite the side opening as separate and distal to the “substantially rigid portion/segment.”

Following the denial of Teleflex’s first preliminary injunction request, the district court stayed the action pending the results of inter partes review (“IPR”) proceedings–where the Patent Trial and Appeal Board (“PTAB”) found that Medtronic had failed to prove unpatentability of all the asserted claims.

Upon filing its second preliminary injunction request, Teleflex applied its various claims to Medtronic’s telescope guide extension catheter. Teleflex identified a portion of Medtronic’s telescope that included the pushwire, spade mark, and rigid plastic as a “substantially stiff portion” (“Group One limitations”) for claims reciting this side opening. For claims reciting a separate []side-opening portion distal from a substantially stiff portion (“Group Two restrictions”), Teleflex indicated the substantially rigid part as stopping at the opening. The district court took issue with Teleflex’s attempt to construe the claims in a way that would allow Teleflex to successfully assert Group One and Group Two limitations against the same accused product, and accordingly denied the second injunction request.Next, the district court turned to the issue of claim construction of the term “substantially rigid portion/segment,” where it reached an impasse after rejecting both proposed constructions. At the parties’ recommendation, former United States Patent and Trademark (“USPTO”) Director Andrei Iancu was appointed to propose his own construction, or in the alternative, provide a written report stating why he finds the terms to be indefinite.Iancu found the term not indefinite and proposed that the term be construed as “the first proximal section of a multi-section guide extension catheter, that ends where there is a material drop in the overall rigidity of the guide extension catheter at or distally to the proximal end of the coaxial lumen where an interventional cardiology device is inserted.” Despite recognizing that Iancu’s construction was inconsistent with the Group Two claims, Teleflex argued that the district court should adopt his construction, as the construction would allow for potential infringement of both Group One and Group Two claims. Medtronic argued this construction would render Group Two claims “nonsensical”, and that the claims are indefinite because they seek to cover a product in a mutually-exclusive manner. Therefore, adopting this interpretation should render all claims null. The district court agreed with Medtronic that the claims should be invalidated because they were mutually exclusive–and thus indefinite.

Teleflex appealed, arguing that the district court erred in finding the claims indefinite. It argued that the boundary of a substantially rigid portion is dependent on the other claim language used in a particular claim, because the claims divide the device in various ways. In some combinations, a side opening may be considered a separate segment while in others it is included in the substantially rigid section. The district court “forced itself into a later conclusion of indefiniteness, which it did not have to do” by finding the claims mutually-exclusive. Accordingly, the CAFC instructed the district court to conduct claim construction on a claim-by-claim basis with the understanding that the claims aren’t necessarily mutually exclusive as each independent claim is a “different ordered combination of limitations.” By finding the claims mutually exclusive, the district court “forced itself into a later conclusion of indefiniteness, which it did not have to do.” Accordingly, the CAFC instructed the district court to conduct claim construction on a claim-by-claim basis with the understanding that the claims are not necessarily mutually exclusive as each independent claim is a “different ordered combination of limitations.”

Further, the CAFC held that the boundary of the “substantially rigid portion/segment” does not have to be consistent across claims because it is a functional limitation wherein “the substantially rigid portion is a portion of the catheter that is substantially rigid enough to achieve some function.” The opinion acknowledges that “a claim term should be construed consistently with its appearance in other places in the same claim or in other claims of the same patent.” Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir. Cir. Co., Ltd. Elm 3DS Innovations, LLC, 992 F.3d 1373,1378 (Fed. Cir. Cir. Cir. However, the CAFC emphasized that this ruling is not inconsistent with precedent, but instead clarifies that the term “substantially rigid portion” can be construed “the same way across the patents, but that construction can be a functional construction that does not specify the boundary of the ‘substantially rigid portion.'” In other words, the meaning of a claim term can vary as it relates to other claim terms without being inconsistent.

The CAFC then vacated and remanded.

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