Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., et al., Nos. 2023-1864, -1940 (Fed. Cir. (PTAB) July 14, 2025). Opinion by Dyk, joined by Lourie and Cunningham.
CSI filed an IPR petition challenging all claims of a Shockwave patent directed to a balloon catheter system for treatment of atherosclerosis. In a final written decision, the Patent Trial and Appeal Board found that CSI proved claims 1-4 and 6-17, but not claim 5, unpatentable as obvious. Shockwave appealed, and CSI cross-appealed as to claim 5.
The Federal Circuit affirmed the unpatentability determination for claims 1-4 and 6-17. The court held that the Board did not improperly rely on applicant admitted prior art (AAPA) to supply a basis for the petition. The court explained that “AAPA may be used as evidence of background knowledge of an ordinary skilled artisan” and that “it is permissible for general knowledge to supply a missing claim limitation in an IPR” so long as it is not the “basis” of a ground.
The Federal Circuit distinguished a recent decision where AAPA was the “basis” for a ground of unpatentability. Unlike the petitioner in that case, here CSI used AAPA “only to show … that the over-the-wire angioplasty balloon catheter was well known in the prior art and that this general background knowledge satisfied the ’371 patent’s claim limitations relating to an over-the-wire configuration.” The court explained: “What matters for the purposes of [35 U.S.C.] § 311(b) is the grounds raised in the petition, and CSI’s petition never phrased the AAPA in terms of constituting a basis for its obviousness arguments.”
Next, the Federal Circuit held that the Board did not error in denying Shockwave’s construction of the claim term “angioplasty balloon.” The court ruled that “nothing in the language of the claims or specification” supported Shockwave’s construction, and the specification contained embodiments not limited in the manner required by Shockwave’s construction. The Federal Circuit also rejected Shockwave’s challenges to three of the Board’s factual findings because substantial evidence supported each of the findings.
As to CSI’s cross-appeal, the Federal Circuit reversed the Board’s determination that claim 5 was not proved unpatentable. To begin, the court ruled that CSI had standing to appeal. CSI had an intravascular lithotripsy (IVL) product in its final stages, CSI had engaged with the FDA and was close to initiating clinical trials for the product, and Shockwave’s President had publicly stated that “we believe that any viable, much less commercially viable, IVL device must contain these elements [of claim 5].” The Federal Circuit thus held that CSI demonstrated engagement in “activity that creates a substantial risk of future infringement” that is “likely to cause the patentee to assert a claim of infringement.”
On the merits, the Federal Circuit ruled that the Board erred in upholding the patentability of claim 5. The Board had predicated its finding on a single prior art reference rather than considering the prior art combination as a whole. The Federal Circuit held that “the Board’s failure to consider the combined teachings of the prior art led it to improperly discount CSI’s argument in its petition”—an argument that demonstrated unpatentability.
Top Brand LLC, et al. v. Cozy Comfort Co. LLC, et al., No. 2024-2191 (Fed. Cir. (D. Ariz.) July 17, 2025). Opinion by Dyk, joined by Reyna and Stark.
Top Brand and Cozy Comfort compete in the market of oversized hooded sweatshirts. Cozy Comfort owns a design patent and two trademarks for “THE COMFY.” Top Brand sought declaratory relief of noninfringement of the design patent, and Cozy Comfort counterclaimed for infringement of the design patent and the two trademarks. A jury found infringement of both the patent and the trademarks. The district court denied Top Brand’s post-trial motions, and Top Brand appealed.
First, although Cozy Comfort argued that the doctrine of prosecution history disclaimer does not apply to design patents, the Federal Circuit disagreed. The court explained that “it would be contrary to the very purpose of design patent prosecution to allow the patentee to make arguments in litigation contrary to the representations which led to the grant of the patent in the first place, and thereby recapture surrendered claim scope.” Thus, the Federal Circuit held that “the principles of prosecution history disclaimer apply to design patents.”
Applied here, the court ruled that “multiple significant aspects of the accused products are the same ones Cozy Comfort disclaimed during prosecution, and they cannot be relied on to show design similarity between the accused and patented designs.” Accordingly, the Federal Circuit held that “Top Brand was entitled to [judgment as a matter of law (JMOL)] of noninfringement of the design patent because the accused infringing design was within the scope of the subject matter surrendered during prosecution.”
Second, the Federal Circuit held that substantial evidence does not support the jury’s verdict of federal trademark infringement. The court ruled that Cozy Comfort’s mark “THE COMFY” is “entitled to weak protection” because the dominant part of the mark, “comfy,” is “descriptive or highly suggestive” of the goods and services at issue. Also, Cozy Comfort did not show secondary meaning. Still further, the evidence failed to establish that Top Brand had used the word “Comfy” as a source identifier; instead, Top Brand had used the word to describe the product and how soft it is. Thus, the Federal Circuit reversed the district court’s denial of JMOL of no trademark infringement.
Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153 (Fed. Cir. (C.D. Cal.) July 18, 2025). Opinion by Taranto, joined by Hughes and Stoll.
Colibri owns a patent that claims a method, for use in trying to implant an artificial heart valve to replace a defective valve, that furnishes a do-over opportunity to the installer to get the positioning right. In the method, the replacement valve is only partially deployed and can be recaptured before full deployment if it appears the positioning will be off. During prosecution of the patent, two independent claims recited such a method of partial deployment: one claimed pushing out the valve from an outer sheath of the delivery apparatus, and one claimed retracting the outer sheath to expose the valve. The examiner rejected the latter claim for lack of written description, and Colibri canceled it. The patent then issued with an independent claim reciting partial deployment by pushing, and no claims expressly reciting partial deployment by retracting.
Colibri sued Medtronic for infringement. In response, Medtronic argued that Colibri’s assertion of infringement under the doctrine of equivalents was barred by prosecution history estoppel, but the district court disagreed. The case proceeded to trial where Colibri asserted infringement of claim 1 under the doctrine of equivalents. A jury found infringement and awarded Colibri more than $106 million in damages. Medtronic appealed.
The Federal Circuit reversed, concluding that “Colibri’s cancellation during prosecution of [a claim], which recited ‘retracting the moveable sheath,’ bars Colibri from asserting infringement under the doctrine of equivalents under the theory that a combination of applying a pushing force to the pusher member while retracting the moveable sheath (what Medtronic’s device does) is equivalent to, i.e., not substantially different from, ‘pressing against the pusher member with a force that moves the pusher member outward from the moveable sheath’ (what claim 1 requires).”
Both in the district court and on appeal, Colibri repeatedly asserted that skilled artisans would understand that pushing necessarily accompanies retracting. Thus, relying on “Colibri’s own affirmative theory of equivalence,” the Federal Circuit concluded that the district court was incorrect that Colibri’s asserted equivalent differed from what was set forth in the claim canceled during prosecution. The Federal Circuit emphasized that “narrowing is a prerequisite to prosecution history estoppel” and observed that “it can exist, and we conclude here does exist, as a substantive matter based on canceling a closely related claim involving such intertwined terminology that canceling one claim necessarily communicated that the scope of the other claim had narrowed.”
The Federal Circuit rejected Colibri’s contention that claim 1 itself had to be amended for prosecution history estoppel to apply. “The close substantive relationship between the canceled and retained claims, by Colibri’s own basic-physics logic for its affirmative assertion of equivalence, is enough to cross the estoppel threshold.” Thus, “in the absence of further arguments about the scope of narrowing or exceptions to the presumption of estoppel, the doctrine of equivalents became unavailable to Colibri for the issued claim 1.”