Federal Circuit Upholds Import Ban on Apple Watch Over Blood Oxygen Sensor Patents

APPLE INC. v. ITC

Authored by: Jeremy J. Gustrowsky

The Federal Circuit has affirmed the International Trade Commission’s finding that Apple violated Section 337 of the Tariff Act by importing Apple Watch models that infringed patents owned by Masimo Corporation and Cercacor Laboratories. The patents at issue, U.S. Patent Nos. 10,912,502 and 10,945,648, cover wearable devices that noninvasively measure a user’s blood oxygen saturation using light-emitting diodes and photodetectors. When Apple launched the Apple Watch Series 6 in September 2020 with a blood oxygen sensing feature, Masimo brought a complaint to the ITC, which ultimately issued a limited exclusion order barring importation of the infringing watches. Apple appealed, challenging the domestic industry requirement, claim construction, infringement, validity, and prosecution laches. The Federal Circuit rejected every one of Apple’s arguments.

A major portion of the appeal focused on whether Masimo satisfied the “domestic industry” requirement of Section 337, which demands that a U.S. industry exist relating to products protected by the asserted patents. Apple argued that Masimo relied on a “hypothetical” watch rather than an actual, physical product. The court disagreed, finding that Masimo’s complaint identified the “Masimo Watch” as the domestic industry article, and that multiple physical prototypes (referred to as the RevA, RevD, and RevE sensors) existed before the complaint was filed and practiced the asserted patent claims. The court confirmed that circumstantial evidence, including witness testimony about testing the devices’ blood oxygen functionality, was entirely proper to establish that patent-practicing articles existed. The court also rejected Apple’s argument that investments in earlier, non-patent-practicing prototypes (the “Circle” and “Wings” sensors) could not count toward Masimo’s economic investment showing, holding that those investments were part of an iterative design process that directly led to the patent-practicing devices.

On infringement, Apple challenged the ITC’s constructions of two sets of claim terms. First, Apple argued that the terms “over” and “above” required a specific vertical orientation relative to the ground. The court instead agreed with the ALJ that these terms describe how one component covers another within the device, regardless of the device’s physical orientation during use. Second, Apple contended that “openings” and “through holes” must be completely empty of material. The court rejected this too, pointing to claim language and specification passages expressly describing openings filled with optically transparent material like glass. Because Apple’s infringement challenges depended entirely on these alternative claim constructions, the court affirmed the infringement finding.

Apple also challenged the validity of the asserted claims on two grounds. First, Apple argued the patents lacked adequate written description because no single embodiment in the specification disclosed all of the claimed features together. The court found substantial evidence that the specification linked the various embodiments and expressly stated they could be combined, meaning the inventors demonstrated possession of the full claimed invention. Second, Apple argued the claims were obvious over a prior art reference called “Lumidigm” (U.S. Patent No. 7,620,212). The court upheld the ALJ’s finding that Lumidigm does not disclose measuring blood oxygen saturation at all, which is a required limitation of every asserted claim. Testimony from one of Lumidigm’s own inventors confirmed he never made a device that calculated blood oxygen.

Finally, the court rejected Apple’s prosecution laches defense. Apple argued that Masimo unreasonably delayed filing the patent applications that became the asserted patents, waiting from 2008 to September 2020. The ALJ found no unreasonable delay, crediting evidence of continuous prosecution activity throughout that period and finding no evidence that Masimo deliberately timed its claims to target Apple’s products. The Federal Circuit saw no abuse of discretion in that determination and affirmed the ITC’s exclusion order in full.