UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`
`
`
`
`
`
`
`
`
`
`
`In the Matter of
`
`CERTAIN LIGHT-BASED
`PHYSIOLOGICAL MEASUREMENT
`DEVICES AND COMPONENTS
`THEREOF
`
`
`
`
`
`Investigation No. 337-TA-1276
`
`
`
`
`
`
`Notice.
`
`NOTICE OF THE COMMISSION’S FINAL DETERMINATION FINDING A
`VIOLATION OF SECTION 337; ISSUANCE OF A LIMITED EXCLUSION ORDER
`AND A CEASE AND DESIST ORDER; TERMINATION OF THE INVESTIGATION
`
`AGENCY: U.S. International Trade Commission.
`
`ACTION:
`
`SUMMARY: Notice is hereby given that the U.S. International Trade Commission has found a
`violation of section 337 in the above-captioned investigation. The Commission has determined
`to issue: (1) a limited exclusion order (“LEO”) prohibiting the unlicensed entry of infringing
`wearable electronic devices with light-based pulse oximetry functionality and components
`thereof covered by certain claims of U.S. Patent Nos. 10,912,502 or 10,945,648 that are
`manufactured by or on behalf of, or imported by or on behalf of, respondent Apple, Inc.
`(“Apple”) or any of its affiliated companies, parents, subsidiaries, or other related business
`entities, or its successors or assigns; and (2) a cease and desist order (“CDO”) directed against
`Apple and any of its affiliated companies, parents, subsidiaries, or other related business entities,
`or its successors or assigns. This investigation is terminated.
`
`FOR FURTHER INFORMATION CONTACT: Ronald A. Traud, Esq., Office of the General
`Counsel, U.S. International Trade Commission, 500 E Street S.W., Washington, D.C. 20436,
`telephone (202) 205-3427. Copies of non-confidential documents filed in connection with this
`investigation may be viewed on the Commission’s electronic docket (EDIS) at
`https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. General
`information concerning the Commission may also be obtained by accessing its Internet server at
`https://www.usitc.gov. Hearing-impaired persons are advised that information on this matter can
`be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.
`
`SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on
`August 18, 2021, based on a complaint filed on behalf of Masimo Corporation and Cercacor
`Laboratories, Inc., both of Irvine, CA (collectively, “Complainants”). 86 FR 46275 (Aug. 18,
`2021). The complaint, as amended, 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. 10,912,501 (“the ’501 patent”); U.S. Patent No. 10,912,502 (“the ’502
`patent”); U.S. Patent No. 10,945,648 (“the ’648 patent”); U.S. Patent No. 10,687,745 (“the ’745
`patent”); and U.S. Patent No. 7,761,127 (“the ’127 patent”). Id. The amended complaint further
`alleged that an industry in the United States exists and/or is in the process of being established as
`required by section 337. Id. The notice of investigation named Apple of Cupertino, California
`as the sole respondent. Id. at 46276. The Office of Unfair Import Investigations is not
`participating in this investigation. Id.
`
`
`Complainants previously withdrew certain asserted claims pursuant to Order No. 25
`(Mar. 23, 2022), unreviewed by Comm’n Notice (Apr. 12, 2022), and Order No. 33 (May 20,
`2022), unreviewed by Comm’n Notice (June 10, 2022). Only claim 12 of the ’501 patent, claims
`22 and 28 of the ’502 patent, claims 12, 24, and 30 of the ’648 patent, claims 9, 18, and 27 of the
`’745 patent, and claim 9 of the ’127 patent remain in the investigation. Claim 18 of the ’745
`patent is still at issue for purposes of the domestic industry only.
`
`
`On January 10, 2023, the presiding administrative law judge (“ALJ”) issued the final
`initial determination (“Final ID”), which found that Apple violated section 337 as to claims 24
`and 30 of the ’648 patent, but not as to claim 12 of the ’501 patent, claims 22 and 28 of the ’502
`patent, claim 12 of the ’648 patent, claims 9 and 27 of the ’745 patent, and claim 9 of the ’127
`patent. See Final ID at 335–36. On January 24, 2023, the ALJ issued a Recommended
`Determination on remedy and bonding (“RD”) should a violation be found in the above-
`captioned investigation. The RD recommended that, if the Commission finds a violation, it
`should issue an LEO directed to certain wearable electronic devices with light-based pulse
`oximetry functionality and components thereof that are imported, sold for importation, and/or
`sold after importation by Apple; and a CDO directed to Apple. RD at 2, 5. The RD additionally
`recommended that the Commission set a zero percent (0%) bond (i.e., no bond) during the sixty-
`day period of Presidential review. Id. at 6. In its notice instituting this investigation, the
`Commission did not instruct the ALJ to make findings and recommendations concerning the
`public interest. See 86 FR at 46275–76.
`
`On January 23, 2023, Complainants and Apple each filed a petition for review. On
`January 31, 2023, Complainants and Apple each filed responses to the other party’s petitions.
`
`On February 23, 2023, the parties filed their public interest statements pursuant to 19
`CFR 210.50(a)(4). The Commission received numerous comments on the public interest from
`non-parties.
`
`On May 15, 2023, after considering the parties’ petitions and responses thereto, the
`Commission determined to review the Final ID in part. See 88 FR 32243, 32243–46 (May 19,
`2023). In particular, the Commission determined to review the following findings of the Final
`ID:
`
`
`
`
`
`
`
`2
`
`

`

`(1) the domestic industry with regard to the ’501 patent, the ’502 patent, the ’648 patent,
`and the ’745 patent;
`
`
`(2) obviousness with regard to the ’501 patent, the ’502 patent, the ’648 patent, and the
`’745 patent;
`
`
`(3) written description with regard to claim 28 of the ’502 patent and claim 12 of the ’648
`patent;
`
`
`(4) claim construction and infringement with regard to the ’745 patent; and
`
`(5) subject matter jurisdiction.
`
`Id. The Commission requested briefing on certain issues under review and on remedy, the public
`interest, and bonding. See id.
`
`On June 5, 2023, the parties filed their written submissions on the issues under review
`and on remedy, public interest, and bonding, and on June 12, 2023, the parties filed their reply
`submissions. The Commission also received numerous comments on the public interest from
`non-parties.
`
`Having reviewed the record in this investigation, including the written submissions of the
`parties, the Commission affirms with modifications the Final ID’s domestic industry findings
`(both economic and technical prong) as to the ’501, ’502, ’648, and ’745 patents. The
`Commission additionally affirms with modifications the Final ID’s conclusion that the asserted
`claims of the ’501 patent are obvious, but the asserted claims of the ’502, ’648, and ’745 patents
`are not obvious. The Commission has determined to reverse the Final ID’s finding that Apple
`proved by clear and convincing evidence that claim 28 of the ’502 patent and claim 12 of the
`’648 patent are invalid for lack of written description. Furthermore, the Commission affirms the
`Final ID’s claim construction related to the recited term “first shape” and the related conclusion
`that the Accused Products do not satisfy elements [1B] and [20B] of the ’745 patent. The
`Commission additionally vacates the Final ID’s finding that the Commission has subject matter
`jurisdiction over the investigation and instead finds that the Commission has statutory authority
`over the investigation. The Commission affirms the remainder of the Final ID that is not
`inconsistent with the Commission’s opinion issued concurrently herewith. As a result, the
`Commission finds that Apple has violated section 337 as to claims 22 and 28 of the ’502 patent
`and claims 12, 24, and 30 of the ’648 patent.
`
`The Commission has determined that the appropriate form of relief is an LEO prohibiting
`(1) the unlicensed entry of infringing wearable electronic devices with light-based pulse
`oximetry functionality and components thereof manufactured by or on behalf of Apple or any of
`its affiliated companies, parents, subsidiaries, or other related business entities, or its successors
`or assigns. The Commission has also determined to issue a CDO against Apple. The
`Commission has determined to include an exemption to the remedial orders for service or repair
`
`
`
`
`3
`
`

`

`or, under warranty terms, replacement of products purchased prior to the end of the period of
`Presidential review.
`
`The Commission has further determined that the public interest factors enumerated in
`subsections (d)(l) and (f)(1) (19 U.S.C. 1337(d)(l), (f)(1)) do not preclude issuance of the above-
`referenced remedial orders. Additionally, the Commission has determined to impose a bond of
`zero (0%) (i.e., no bond) of entered value of the covered products during the period of
`Presidential review (19 U.S.C. 1337(j)). This investigation is terminated.
`
`
`The Commission vote for this determination took place on October 26, 2023.
`
`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).
`
`
`
`
`
`
`By order of the Commission.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Issued: October 26, 2023
`
`
`
`
`
`
`Lisa R. Barton
`Secretary to the Commission
`
`
`
`
`
`4
`
`