SUPPLEMENTARY INFORMATION:

The Commission instituted the underlying investigation in August 2021, based on an amended and supplemented complaint filed by complainants Masimo Corporation (“Masimo”) and Cercacor Laboratories, Inc. (together with Masimo, “Complainants”). 86 FR 46275-76 (Aug. 18, 2021). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain light-based physiological measurement devices and components thereof by reason of infringement of certain claims of U.S. Patent No. 10,912,502 (“the '502 patent”), U.S. Patent 10,945,648 (“the '648 patent,” and together with the '502 patent, “Asserted Patents”), U.S. Patent No. 10,912,501, U.S. Patent No. 10,687,745, and U.S. Patent No. 7,761,127. Id. The Complaint further alleged that an industry in the United States exists and/or is in the process of being established. Id. The notice of investigation named Apple Inc. of Cupertino, California (“Apple”) as the sole respondent. Id. at 46276. The Commission's Office of Unfair Import Investigations (“OUII”) did not participate in the underlying investigation. See id.

In January 2023, the ALJ issued the final initial determination on violation (“FID”), which found that Apple violated section 337 as to only claims 24 and 30 of the '648 patent. In May 2023, the Commission determined to review the FID in part. See88 FR 3224-44 (May 19, 2023).

In October 2023, the Commission issued its final determination in the underlying investigation, finding Apple in violation of section 337 as to claims 22 and 28 of the '502 patent and claims 12, 24, and 30 of the '648 patent. 88 FR 75032-33 (Nov. 1, 2023). To remedy Apple's violation, the Commission issued both a limited exclusion order (“LEO”) and a cease and desist order (together with the LEO, “Remedial Orders”). Id.

On September 9, 2025, Masimo filed a petition with the Commission pursuant to Commission Rule 210.76 requesting clarification of, or in the alternative, a modification proceeding to modify, the Remedial Orders.

On November 18, 2025, the Commission instituted this combined modification and enforcement proceeding to determine whether Apple's second redesigned products infringe the Asserted Patents. 90 FR 51791-92 (Dec. 2, 2025). OUII did not participate in this proceeding. See id.

On March 18, 2026, the ALJ issued the EID, which ultimately concluded that the accused redesigned products did not infringe the asserted claims of the Asserted Patents. On March 25, 2026, Masimo and Apple each filed a petition for Commission review of the EID. On March 30, 2026, the parties each filed responses to the respective petitions.

The Commission has determined not to review the EID. This combined proceeding is hereby terminated in its entirety with the conclusion that the accused redesigned products do not infringe the Asserted Patents, and therefore, they should not be excluded pursuant to the terms of the LEO.

The Commission vote for this determination took place on April 17, 2026.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

91 FR 21510