In our Case of the Week, the Federal Circuit upheld a major ruling from the International Trade Commission against Apple Inc. in its patent dispute with Masimo Corporation, confirming that certain Apple Watch models infringed Masimo’s blood-oxygen monitoring patents and were properly the subject of an exclusion order barring their importation.

The patents at issue, U.S. Patent Nos. 10,912,502 and 10,945,648, cover “wearable technology that measures user physiological metrics by way of optical emitters and photodetection.” The patents claim methods for emitting light into the skin, detecting how much light is absorbed by oxygenated versus deoxygenated blood, and processing that data to produce blood oxygenation readings. The innovations at issue focused on improving measurement accuracy in small, wearable devices, particularly by reducing noise from motion and low perfusion, which are common challenges in wrist-based monitoring devices like smartwatches.

After the launch of the Apple Watch Series 6, Masimo filed a complaint with the International Trade Commission (ITC) under Section 337 of the Tarriff Act, alleging that Apple’s importation and sale of Apple Watches that measure blood oxygenation infringed Masimo’s patents. After conducting a Section 337 investigation, the ITC found that Apple’s devices infringed Masimo’s ‘648 and ‘502 patents and that Masimo had established a domestic industry based on its U.S. research and development activities. The full Commission reviewed and largely adopted these findings, ultimately issuing a limited exclusion order barring the importation of infringing Apple Watches, along with a cease-and-desist order restricting Apple’s domestic activities related to those products. On appeal, Apple challenged the ruling on multiple grounds, including ITC’s findings of infringement, validity, and satisfaction of the “domestic industry” requirement under Section 337.

First, the Federal Circuit affirmed ITC’s finding that Masimo met the “domestic industry” requirement, which requires a complainant to establish that it practices the asserted patents and that it has made significant investments in the United States related to those patents. The Court held that Masimo’s evidence, which included prototype devices of Masimo watch products, reflected embodiments of the asserted claims, and rejected Apple’s view that reliance on circumstantial evidence is improper. The Court also affirmed the Commission’s findings that Masimo’s substantial U.S.-based research and development, even without widespread commercial sales, satisfied the domestic industry requirement.

Second, the Federal Circuit affirmed infringement of Masimo’s ‘648 and ‘502 patents. Apple had challenged certain of the ITC’s claim constructions, but the Court found those constructions aligned with the plain and ordinary meaning of the words as used in the field of wearable medical equipment and the patents’ shared specifications.

The Federal Circuit also rejected Apple’s argument that the asserted claims were invalid due to inadequate written description, holding that the ITC’s findings were reasonable and supported by substantial evidence. The Federal Circuit also rejected Apple’s obviousness challenge, holding that Masimo’s patents were not rendered obvious by the prior art. The Court found that the combination of prior art references cited by Apple did not disclose or suggest the specific claimed methods for accurately measuring blood oxygen, and emphasized the testimony of an inventor of the prior art who stated that “he never made a device that calculated blood oxygen.”

Finally, the Court rejected Apple’s laches defense, concluding that Masimo’s delay in prosecuting its patents was not unreasonable or prejudicial. The Federal Circuit noted that there was continuous prosecution activity between 2008 when the provisional applications were filed, and 2020 when Masimo filed the applications that led to the asserted patent claims.

The opinion can be found here.

By Brittani Gambrell