[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 75032-75033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24071]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1276]


Certain Light-Based Physiological Measurement Devices and 
Components Thereof; 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: Notice.

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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: 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 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 SW, 
Washington, DC 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 
[email protected]. 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

[[Page 75033]]

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:
    (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 
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.
Katherine Hiner,
Supervisory Attorney.
[FR Doc. 2023-24071 Filed 10-31-23; 8:45 am]
BILLING CODE 7020-02-P