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`PUBLIC VERSION
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`Office of the Secretary
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
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`Washington, D.C. 20436
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`October 26, 2023
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`Dax Terrill, Chief
`Exclusion Order Enforcement Branch
`U.S. Customs and Border Protection
`Regulations and Rulings – Office of Trade
`90 K Street NE – 10th Floor
`Washington, DC 20229-1177
`
`Re:
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`Limited exclusion order issued by the U.S. International Trade Commission in
`Investigation No. 337-TA-1276, Certain Light-Based Physiological Measurement
`Devices and Components Thereof.
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`Dear Mr. Terrill:
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`On October 26, 2023, the United States International Trade Commission issued a limited
`exclusion order prohibiting Apple, Inc. of Cupertino, California from importing into the United States
`light-based physiological measurement devices and components thereof that infringe one or more of
`claims 22 and 28 of U.S. Patent No. 10,912,502 and claims 12, 24, and 30 of U.S. Patent No.
`10,945,648 (collectively, the “subject patents”).
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`The owner of the subject patents is Masimo Corporation of Irvine, California. Kendall M.
`Loebbaka (tel. (949) 760-0404), of the law firm Knobbe, Martens, Olson & Bear, LLP, was counsel
`for complainant in the proceedings before the Commission.
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`The products in question are believed to be imported under at least HTSUS Number
`8517.62.0090.
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`The Commission’s order is in effect until the subject patent(s) expire(s) or one or more of its
`claims are rendered invalid or unenforceable. The expiration date for both patents is August 25,
`2028. A copy of each of the subject patents is enclosed. We separately transmitted the limited
`exclusion order to you, along with the Commission record, on the day of its issuance.
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`Per the limited exclusion order, the covered products are entitled to entry for consumption
`into the United States, entry for consumption from a foreign trade zone, or withdrawal from a
`warehouse for consumption with no bond (i.e., 0% bond) from the day after this order is received by
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`Chief Tenill
`October 26, 2023
`Page2
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`the United States Trade Representative, pursuant to subsection G) of section 337 of the Tariff Act of
`1930, as amended, and the Presidential Memorandum of July 21, 2005 (70 FR 43251), until such time
`as the Representative notifies the Commission of approval or disapproval of this action but, in any
`event, not later than sixty (60) days after the date of receipt of this action.
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`If you have any questions concerning the limited exclusion order, please feel free to contact
`Ron Traud (202-205-3427, ronald.traud@usitc.gov) or Michelle Klancnik (202-205-3104,
`michelle.klancnik@usitc.gov).
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`Sincerely,
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`Lisa R. Barton
`Secreta1y to the Commission
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`Enclosures
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`cc:
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`Office of the General Counsel
`Office of the United States Trade Representative
`600 17th Street, N.W.
`Washington, D.C. 20508
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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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`
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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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`2
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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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`3
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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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`4
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