IP Law Daily, PATENT—Fed. Cir.: ITC’s exclusion order against Apple Watch imports over pulse oximetry patents affirmed, (Mar 20, 2026)

By Ravindra Kumar Singh, B.L.

ITC correctly found that the complainant satisfied the domestic industry requirement and that Apple’s devices infringed valid patent claims.

The U.S. Court of Appeals for the Federal Circuit affirmed the International Trade Commission’s final determination that Apple violated Section 337 of the Tariff Act by importing and selling Apple Watch devices that infringed patents covering wearable blood oxygen measurement technology. The appellate court upheld the Commission’s findings that the patent holder satisfied the domestic industry requirement, that Apple’s products infringed the asserted claims, and that the claims were not invalid for lack of written description or obviousness. It further rejected Apple’s prosecution laches defense, concluding that the Commission’s determinations were supported by substantial evidence and involved no legal error (Apple Inc. v. International Trade Commission, No. 24-1285 (Fed. Cir. Mar. 19, 2026)).

Background. The appellant, Apple Inc., is a global technology company engaged in the design and sale of consumer electronics, including wearable devices such as the Apple Watch. The appellee, the International Trade Commission, is the federal agency responsible for adjudicating unfair trade practices under Section 337. The intervenors, Masimo Corporation and Cercacor Laboratories, Inc., are medical technology companies specializing in non-invasive monitoring solutions, including pulse oximetry systems used to measure blood oxygen saturation. The dispute arose from allegations that Apple incorporated Masimo’s patented technology into its smartwatch products without authorization.

The case centered on U.S. Patent Nos. 10,912,502 (the ’502 patent) and 10,945,648 (the ’648 patent). These patents relate to user-worn devices capable of non-invasively measuring physiological parameters, particularly blood oxygen saturation, using optical emitters and photodetectors. The claimed inventions involve configurations of LEDs, photodiodes, and structural elements such as protrusions with openings designed to improve signal accuracy by controlling light transmission through human tissue.

Masimo filed a complaint before the Commission in June 2021 alleging that Apple’s importation and sale of Apple Watch models with blood oxygen sensing functionality violated Section 337. Following a detailed evidentiary hearing, the administrative law judge found that certain Apple Watch models infringed claims of the ’648 patent and that the patent holder had established a domestic industry. The ALJ also concluded that the asserted claims were not invalid.

On review, the Commission affirmed the finding of a Section 337 violation, determining that Apple infringed multiple claims of both patents that were not proven invalid. It issued a limited exclusion order barring the importation of infringing Apple Watch devices into the United States. Apple appealed, challenging the Commission’s findings on domestic industry, infringement, validity, and enforceability.

Domestic industry requirement. The Federal Circuit first addressed whether the complainant satisfied the domestic industry requirement under Section 337, which includes both technical and economic prongs.

On the technical prong, Apple argued that the Commission improperly relied on a “hypothetical” product rather than an actual article practicing the patents. The court rejected this contention, holding that the Commission permissibly relied on evidence of multiple prototype devices collectively constituting the domestic industry product. The court emphasized that neither the Tariff Act nor Commission regulations require identification of a single specific physical article in the complaint. Instead, representative embodiments supported by record evidence suffice.

Citing Lashify v. ITC, 130 F.4th 948 (Fed. Cir. 2025), the court reiterated that the technical prong requires a comparison akin to infringement analysis—whether a domestic article practices at least one claim. It also relied on Medtronic, Inc. v. Teleflex Innovations S.A.R.L., 70 F.4th 1331 (Fed. Cir. 2023), to confirm that circumstantial evidence may support such findings. The court found substantial evidence, including witness testimony and testing data, demonstrating that pre-complaint prototype devices were user-worn and capable of measuring blood oxygen levels.

On the economic prong, the court upheld the Commission’s finding that the complainant made significant domestic investments in research and development. Relying on Motorola Mobility, LLC v. ITC, 737 F.3d 1345 (Fed. Cir. 2013), the court confirmed that investments in precursor prototypes can qualify if they are directed toward the development of the patented article. The court rejected Apple’s challenge to the accounting methodology, holding that it amounted to an impermissible request to reweigh evidence.

Infringement findings. Apple’s infringement challenge focused on claim construction, particularly the terms “over’ / “above” and “openings” / “through holes.” The court reviewed these constructions de novo and affirmed the Commission’s interpretation.

For “over” and “above,” the court agreed that the terms describe relative positioning of components rather than orientation relative to gravity. The court relied on intrinsic evidence and noted that Apple’s construction would exclude disclosed embodiments, contrary to principles articulated in Pacing Technologies, LLC v. Garmin International, Inc., 778 F.3d 1021 (Fed. Cir. 2015).

For “openings” and “through holes,” the court held that the terms do not exclude the presence of material, including transparent material. Citing Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), the court emphasized that claim terms must be interpreted in light of the specification, which expressly contemplates such configurations.

Because Apple’s infringement arguments depended entirely on its proposed constructions, the court affirmed the Commission’s infringement findings.

Written description. Apple argued that the asserted claims lacked adequate written description under 35 U.S.C. § 112(a), contending that the specification did not disclose the claimed combination of features in a single embodiment.

The court rejected this argument, holding that substantial evidence supported the Commission’s finding that the specification conveyed possession of the claimed inventions. Citing Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Cir. 2021), the court reiterated that the written description requirement is satisfied if the specification reasonably conveys possession to a skilled artisan.

The court found that the specification expressly permitted combining features across embodiments and credited expert testimony supporting that interpretation. It distinguished the case from Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013), where claims were found to be an improper “amalgam” of unrelated disclosures.

The court also upheld the Commission’s finding that the patents supported limitations involving multiple emitters with matching wavelengths, relying on figures and textual disclosures indicating identical or equivalent emitters.

Obviousness. Apple further argued that the claims were obvious in view of prior art, particularly a reference disclosing electro-optical sensors. The court affirmed the Commission’s rejection of this defense, emphasizing that the prior art failed to disclose a key limitation—measurement of blood oxygen saturation. Citing Roku, Inc. v. Universal Electronics, Inc., 63 F.4th 1319 (Fed. Cir. 2023), the court reiterated that obviousness is a legal question with underlying factual determinations reviewed for substantial evidence. The court found that the prior art described general physiological sensing but did not teach or enable blood oxygen measurement. It relied on both documentary evidence and inventor testimony to support this conclusion.

Prosecution laches. Finally, Apple argued that the patents were unenforceable due to prosecution laches, alleging an unreasonable delay in filing the patent applications. The court rejected this defense, affirming the Commission’s finding that there was continuous prosecution activity. Citing Symbol Technologies, Inc. v. Lemelson Medical, Education & Research Foundation, 422 F.3d 1378 (Fed. Cir. 2005), the court noted that laches applies only in egregious cases of delay. Further, the court found no evidence that the patent holder deliberately delayed prosecution to target Apple’s products, and it declined to infer such intent based on speculation alone.

Conclusion. The Federal Circuit’s decision leaves intact the Commission’s exclusion order against Apple Watch imports and reinforces the evidentiary flexibility afforded in Section 337 proceedings.

The Case is No. 24-1285.

Judge: Stark, L.

Attorneys: Mark D. Selwyn (Wilmer Cutler Pickering Hale and Dorr LLP) for Apple Inc. Ronald Traud, U.S. International Trade Commission, for International Trade Commission.

Companies: Apple Inc.

Cases: Patent FedCirNews GCNNews