Opinions — Friday, June 5, 2026

The Federal Circuit affirmed-in-part and dismissed-in-part the Patent Trial and Appeal Board's final written decisions finding all challenged claims of Carolyn Hafeman's U.S. Patent Nos. 10,325,122, 10,789,393, and 9,892,287 unpatentable in inter partes review proceedings initiated by Google LLC and Microsoft Corporation. The court held that 35 U.S.C. § 314(d) barred review of Hafeman's argument that the Board should have terminated the IPRs after LG Electronics—named as a real party in interest—allegedly violated a so-called "Sotera stipulation" in parallel district court litigation, because this challenge sought to dislodge institution itself rather than address a separate post-institution error. On the merits, the court affirmed the Board's claim construction of the "without assistance by a user" limitation, holding that the phrase modifies only the action of "initiating or changing" return information displayed to the user, not the antecedent step of establishing remote communication, and thus prior art reference Jenne—which disclosed remotely updating commercial messages after a user logged in—taught the limitation. The court also affirmed the Board's rejection of Hafeman's secondary considerations evidence, agreeing that she failed to establish nexus between her Retriever product and evidence of praise, commercial success, and copying.

This decision reinforces that § 314(d)'s bar on judicial review extends beyond direct challenges to institution decisions to encompass challenges that substantively seek to unwind institution even when framed as attacks on final written decisions or post-institution Board conduct. The court's analysis makes clear that where the requested remedy—here, termination of the IPRs based on a petitioner's or real party in interest's violation of a Sotera stipulation that influenced the institution decision—would effectively reverse institution, § 314(d) forecloses appellate review regardless of whether the alleged violation occurred post-institution. The claim construction holding provides guidance on parsing functional limitations involving user interaction, distinguishing between actions performed by users to enable system functionality and actions that must occur without user involvement once the system is operational. The nexus analysis underscores that patent owners must rigorously connect commercial products to specific claimed features when relying on objective indicia of nonobviousness, particularly where the commercial embodiment may incorporate both claimed and unclaimed features.

The Federal Circuit affirmed the district court's finding that Nexus Pharmaceuticals infringed Melinta's U.S. Patent Nos. 9,084,802 and 9,278,105, which claim methods of treating bacterial infections with minocycline formulations containing magnesium to reduce injection site hemolysis. Nexus challenged the district court's claim construction and written description findings for the '802 patent, arguing that its generic product did not infringe because the claimed "composition" excludes diluents required for intravenous administration and that the patent lacked written description support for comparing the claimed formulation to compositions containing other metal cations like calcium. The court declined to reach validity challenges to the '105 patent because both patents share the same expiration date.

On claim construction, the Federal Circuit held that while claim 1 uses the closed term "consists of" and does not list a diluent as an ingredient, intrinsic and extrinsic evidence—including the specification's admixture preparation instructions, expert testimony, and prescribing information—established that a person of ordinary skill would understand dilution is necessary before administration. On written description, the court applied clear error review and held that the claim limitation requiring reduced hemolysis "relative to intravenous administration of a composition that does not include magnesium" naturally compares the claimed formulation to the prior art minocycline product lacking any metal cations, not to formulations containing calcium or other divalent cations, based on the specification's focus, the inventor's testimony, and prosecution history statements identifying the closest prior art.