Office of the Secretary
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
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`WASHINGTON, DC 20436
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`November 2, 2023
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`VIA EMAIL: joe.re@knobbe.com
`Joseph R. Re, Esq.
`Knobbe, Martens, Olson & Bear
`2040 Main St., 14th Floor
`Irvine, CA 92614
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`Re: Exclusion Order in Certain Light-Based Physiological Measurement
`Devices and Components Thereof, Inv. No. 337-TA-1276
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`Dear Mr. Re:
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`On October 26, 2023, the Commission, having found defaulting respondents in violation
`of Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the above-referenced
`investigation, issued a limited exclusion order. The exclusion order directs U.S. Customs and
`Border Protection to exclude certain lighted-based physiological measurement devices and
`components thereof from entry into the United States while U.S. Patent No. 10,912,502 and
`10.945,648 remain enforce. A copy of the order is attached to this letter.
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`Should the Complainants, Cercacor Laboratories, Inc. and Masimo Corporation, have
`questions about the administration of this order, they may contact the Intellectual Property Rights
`Branch of U.S. Customs and Border Protection at (202) 325-0020. Although Customs will be
`administering the exclusion order, you may also contact Megan Valentine, the Commission’s
`Assistant General Counsel for Section 337 investigations, at (202) 708-2301, if you have
`questions pertaining to the exclusion order.
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`Since FY 2000, the Commission has conducted four surveys of exclusion order holders to
`help assess the effectiveness of such orders, and the Commission anticipates conducting another
`such survey in the future. To facilitate future communications with Complainants about the
`anticipated survey, the Commission requests that Complainants identify a person at Cercacor
`Laboratories, Inc. and Masimo Corporation with knowledge of the order who may be contacted
`in the future regarding the survey. It would be particularly helpful if Complainants would
`provide an e-mail address, along with a name and mailing address, for this contact. The
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`requested contact information may be e-mailed to 337_email@usitc.gov or provided by mail to
`Margaret D. Macdonald, Director, Office of Unfair Import Investigations.
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`Sincerely,
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`Enclosure
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`Lisa R. Barton
`Secretary to the Commission
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`Mr. Re, Esq.
`November 2, 2023
`Page 2
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
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`In the Matter of
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`CERTAIN LIGHT-BASED
`PHYSIOLOGICAL MEASUREMENT
`DEVICES AND COMPONENTS
`THEREOF
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`Investigation No. 337-TA-1276
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`LIMITED EXCLUSION ORDER
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`The United States International Trade Commission (“Commission”) has determined that
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`there is a violation of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337), in
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`the unlawful importation, sale for importation, or sale within the United States after importation
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`by respondent Apple, Inc. of Cupertino, California (“Respondent”) of certain light-based
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`physiological measurement devices and components thereof (as defined in paragraph 2 below)
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`that infringe one or more of claims 22 and 28 of U.S. Patent No. 10,912,502 and claims 12, 24,
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`and 30 of U.S. Patent No. 10,945,648 (“Asserted Patents”).
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`Having reviewed the record in this investigation, including the written submissions of the
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`parties, the Commission has made its determinations on the issues of remedy, the public interest,
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`and bonding. The Commission has determined that the appropriate form of relief is a limited
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`exclusion order prohibiting the unlicensed entry of infringing light-based physiological
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`measurement devices and components thereof manufactured by or on behalf of Respondent or
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`any of its affiliated companies, parents, subsidiaries, agents, or other related business entities, or
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`its successors or assigns.
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`The Commission has also determined that the public interest factors enumerated in
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`19 U.S.C. § 1337(d) do not preclude the issuance of the limited exclusion order, and that the
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`bond during the period of Presidential review shall be in the amount of zero percent (0%, i.e., no
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`bond) of the entered value of the entered value of the articles subject to this Order.
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`Accordingly, the Commission hereby ORDERS that:
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`1.
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`Light-based physiological measurement devices and components thereof that
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`infringe one or more of claims 22 and 28 of U.S. Patent No. 10,912,502 and claims 12, 24, and
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`30 of U.S. Patent No. 10,945,648 and are manufactured abroad by, or on behalf of, or imported
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`by or on behalf of Respondent or any of its affiliated companies, parents, subsidiaries, agents, or
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`other related business entities, or its successors or assigns, are excluded from entry for
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`consumption into the United States, entry for consumption from a foreign-trade zone, or
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`withdrawal from a warehouse for consumption, for the remaining terms of the Asserted Patents,
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`except under license from, or with the permission of, the patent owner or as provided by law; and
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`except for parts necessary to service and repair covered products purchased by consumers prior
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`to the date this Order becomes final within the meaning of 19 U.S.C. § 1337(j)(4), and except for
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`covered products that are replacements for covered products purchased by consumers prior to the
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`date this Order becomes final within the meaning of 19 U.S.C. § 1337(j)(4), provided that
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`replacement is pursuant to a warranty for the replaced article.
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`2.
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`The light-based physiological measurement devices and components thereof
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`subject to this exclusion order (i.e., “covered articles”) are as follows: wearable electronic
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`devices with light-based pulse oximetry functionality and components thereof.
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`3.
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`Notwithstanding paragraph 1 of this Order, covered articles are entitled to entry
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`into the United States for consumption, entry for consumption from a foreign trade zone, or
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`withdrawal from a warehouse for consumption, under bond in the amount of zero percent (0%,
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`i.e., no bond) of their entered value, pursuant to subsection (j) of section 337 (19 U.S.C.
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`§ 1337(j)) and the Presidential Memorandum for the United States Trade Representative of July
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`21, 2005 (70 Fed. Reg. 43,251), from the day after this Order is received by the United States
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`Trade Representative until such time as the United States Trade Representative notifies the
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`Commission that this Order is approved or disapproved but, in any event, not later than sixty (60)
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`days after the receipt of this Order. All entries of covered articles made pursuant to this
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`paragraph are to be reported to U.S. Customs and Border Protection (“CBP”), in advance of the
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`date of the entry, pursuant to procedures CBP establishes.
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`4.
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`At the discretion of CBP and pursuant to the procedures it establishes, persons
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`seeking to import articles may be required to certify that they are familiar with the terms of this
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`Order, that they have made appropriate inquiry, and thereupon state that, to the best of their
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`knowledge and belief, the products being imported are not excluded from entry under paragraph
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`1 of this Order. At its discretion, CBP may require persons who have provided the certification
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`described in this paragraph to furnish such records or analyses as are necessary to substantiate
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`the certification.
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`5.
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`In accordance with 19 U.S.C. § 1337(l), the provisions of this Order shall not
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`apply to covered articles that are imported by and for the use of the United States, or imported
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`for and to be used for, the United States with the authorization or consent of the Government.
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`6.
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`The Commission may modify this Order in accordance with the procedures
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`described in Rule 210.76 of the Commission’s Rules of Practice and Procedure (19 C.F.R.
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`§ 210.76).
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`7.
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`The Secretary shall serve copies of this Order upon each party of record in this
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`investigation that has retained counsel or otherwise provided a point of contact for electronic
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`service and upon CBP.
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`8.
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`Notice of this Order shall be published in the Federal Register.
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`By order of the Commission.
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`Lisa R. Barton
`Secretary to the Commission
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`Issued: October 26, 2023
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