Notice2025-20148
Certain Light-Based Physiological Measurement Devices and Components Thereof; Notice of a Commission Determination To Institute a Combined Modification and Enforcement Proceeding
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 18, 2025
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that the U.S. International Trade Commission ("Commission") has determined to institute a combined modification and enforcement proceeding to determine whether importation of certain products violates remedial orders issued in this investigation.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 220 (Tuesday, November 18, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 220 (Tuesday, November 18, 2025)]
[Notices]
[Pages 51791-51792]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20148]
=======================================================================
-----------------------------------------------------------------------
INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1276 (Modification/Enforcement)]
Certain Light-Based Physiological Measurement Devices and
Components Thereof; Notice of a Commission Determination To Institute a
Combined Modification and Enforcement Proceeding
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the U.S. International Trade
Commission (``Commission'') has determined to institute a combined
modification and enforcement proceeding to determine whether
importation of certain products violates remedial orders issued in this
investigation.
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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#387d7c716b0b705d5448784d4b514c5b165f574e"><span class="__cf_email__" data-cfemail="87c2c3ced4b4cfe2ebf7c7f2f4eef3e4a9e0e8f1">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. 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 the underlying
investigation on August 18, 2021, based on a complaint filed on behalf
of Masimo Corporation (``Masimo'') and Cercacor Laboratories, Inc.,
both of Irvine, California. 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
Inc. of Cupertino, California (``Apple'') as the sole respondent. Id.
at 46276. The Office of Unfair Import Investigations did not
participate in this investigation. Id.
Before the presiding administrative law judge (``ALJ'') issued the
final initial determination (``Final ID''), Complainants withdrew from
the investigation certain asserted patent claims. See Order No. 25
(Mar. 23, 2022), unreviewed by Comm'n Notice (Apr. 12, 2022); Order No.
33 (May 20, 2022), unreviewed by Comm'n Notice (June 10, 2022). At the
time of the Final ID, 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
remained in the investigation. Claim 18 of the '745 patent remained at
issue for purposes of the domestic industry only.
On January 10, 2023, the ALJ issued the 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 May 15, 2023, the Commission determined to review the Final ID
in part. See 88 FR 32243, 32243-46 (May 19, 2023). The Commission
requested briefing on certain issues under review and on remedy, the
public interest, and bonding. See id.
On October 26, 2023, the Commission issued its final determination
in this 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, 75032-33 (Nov. 1, 2023). The Commission
issued: (1) a limited exclusion order (``LEO'') prohibiting the
importation of light-based physiological measurement devices and
components thereof that infringe one or more of claims 22 and 28 of the
'502 patent and claims 12, 24, and 30 of the '648 patent; and (2) a
cease and desist order (``CDO'') directed to Apple. Id. The Commission
determined that the public interest factors did not preclude issuance
of the limited exclusion order or the cease and desist order. Id. The
Commission further determined that no bond was to be required during
the period of Presidential review. See id.; 19 U.S.C. 1337(j)(3).
On September 8, 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 issued against Apple. See Complainant Masimo's Request for
Clarification, or in the Alternative, Petition for Modification and
Request for Expedited Treatment. Masimo also requested expedited
treatment of its petition. Id. On September 15, 2025, Apple filed a
response to Masimo's petition, including objecting to the use of a
modification proceeding under section 337(k) in this situation. See
Respondent Apple Inc.'s Response to Masimo's Request for Clarification,
or in the Alternative, Petition for Modification and Request for
Expedited Treatment. The Commission shortened the time for Apple to
file its response. See Letter from Commission Secretary Barton to
Counsel for Apple and Masimo, September 9, 2025. On September 22, 2025,
Masimo and Apple provided a list of undisputed facts, disputed facts,
and claim constructions at issue. Joint Proposed List of Undisputed
Facts, Disputed Facts, and Disputed Claim Terms For September 22, 2025
Submission (``Joint Submission'').
The Commission, having reviewed the record in this investigation,
including Masimo's petition, Apple's response thereto, and their Joint
Submission, has determined to institute a combined modification and
enforcement proceeding. Section 337(k)(1) provides for modification
proceedings when ``the conditions which led to such exclusion from
entry or order no longer exist.'' 19 U.S.C. 1337(k)(1). Commission Rule
210.76 implements the Commission's modification proceedings and
provides, in pertinent part: ``Whenever any person believes that
changed conditions of fact or law, or the public interest, require that
[a remedial order] be modified or set aside, in whole or in part, such
person may request . . . that the Commission make a determination that
the conditions which led to the issuance of [the remedial order] no
longer exist.'' 19 CFR 210.76(a)(1). Rule 210.76 further states that
the request ``shall include materials and argument in support
thereof.'' Id. Section 337(b) provides the
[[Page 51792]]
Commission with the authority to enforce its remedial orders, and
Commission Rule 210.75 implements the Commission's enforcement
proceedings. See VastFame Camera, Ltd. v. Int'l Trade Comm'n, 386 F.3d
1108, 1115 (Fed. Cir. 2004).
The Commission has determined that Masimo's petition complies with
section 337(b), section 337(k)(1), and Commission Rules 210.75 and
210.76. The Commission finds that the circumstances which lead to the
LEO no longer exist and there is a changed condition of fact, insomuch
as Apple has presented a newly redesigned watch, the Apple Redesign 2
Watch, which was not presented during the investigation below.\1\ The
Commission further finds that Masimo's modification petition is
tantamount to a request for enforcement of the LEO because it alleges a
violation of the LEO. See 19 CFR 210.75(a). Accordingly, the Commission
has determined that a combined modification and enforcement proceeding
is proper to determine the narrow issue of whether the Apple Redesign 2
Watch should be excluded under the current terms of the LEO. The
Commission notes that Masimo has not requested civil penalties.
Accordingly, the Commission will not consider whether to issue civil
penalties for any violation of the CDO in this proceeding, but may do
so, upon request, in a subsequent proceeding.
---------------------------------------------------------------------------
\1\ This proceeding includes the Apple Redesign 2 Watch
presented to CBP, Joint Submission ] 32 (undisputed fact), and Apple
Watches subject to a recent over-the-air software update in the
United States, id. ]] 46-48, 117-118, which collectively are the
``Apple Redesign Watch 2.'' To the extent that there are any
differences between the watches presented to CBP and the watches
that have been subject to a recent over-the-air update, the ALJ can
address those differences in the first instance. Moreover, to the
extent that the allegedly infringing functionality requires a
software update to an iPhone, it is assumed for this investigation
that such an update has been applied. Id. ]] 46, 116-117.
---------------------------------------------------------------------------
To further define the issues, the Commission finds, as an initial
matter, that the Apple Redesign 2 Watch on its own is a ``wearable
electronic device'' with at least some ``light-based pulse oximetry
functionality'' pursuant to paragraph 2 of the LEO, and as such, it is
potentially subject to the terms of the LEO. See Joint Submission, ]
47; Certain Light-Based Physiological Measurement Devices & Components
Thereof, Ruling Letter, Inv. No. 337-TA-1276, HQ H338254 at 13 (Jan. 7,
2025). The Commission further finds that Apple manufactured and
imported into the United States the Apple Redesign 2 Watch. LEO,
paragraph 1; Joint Submission, paragraphs 46, 47. Accordingly, the sole
issue to be resolved in this proceeding is whether the Apple Redesign 2
Watch ``infringe[s] claims 22 . . . of U.S. Patent No. 10,912,502 and
claims 12, 24, and 30 of U.S. Patent No. 10,945,648.'' LEO, paragraph
1. The Commission has held that the term ``infringe'' as used in the
Commission's LEOs is not limited to direct infringement but may also
refer to, inter alia, induced infringement under 35 U.S.C. 271(b). See
e.g., Certain Voltage Regulators, Components Thereof and Products
Containing Same, Inv. No. 337-TA-564, Enforcement Comm'n Op., 2010 WL
4780068 at *4 (Aug. 3, 2010). Finally, the Commission notes that Masimo
does not seek a determination of whether the Apple iPhone or the
``Apple Redesign 1 Watch,'' see Joint Submission ]] 26-31 (undisputed
facts), should be excluded pursuant to the LEO, nor does Masimo seek a
determination of whether any article infringes claim 28 of the '502
patent.
The Commission has determined to refer the proceedings to the Chief
ALJ to designate a presiding ALJ to administer appropriate proceedings
consistent with the Commission order issued herewith.
The Commission vote for this determination took place on November
13, 2025.
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: November 14, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-20148 Filed 11-17-25; 8:45 am]
BILLING CODE 7020-02-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 18, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.