UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
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`In the Matter of
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG
`FUNCTIONALITY AND COMPONENTS
`THEREOF
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`Investigation No. 337-TA-1266
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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 Apple Inc. (“Apple” or “Respondent”) of certain wearable electronic devices with ECG
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`functionality and components thereof that infringe one or more of claims 12, 13, and 19-23 of
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`U.S. Patent No. 10,638,941 (“the ’941 patent”); and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S.
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`Patent No. 10,595,731 (“the ’731 patent”) (the ’941 and ’731 patents are collectively referred to
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`herein as “the Asserted Patents”).
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`Having reviewed the record in this investigation, including the written submissions of the
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`parties and non-parties, the Commission has made its determination on the issues of remedy, the
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`public interest, and bonding. The Commission has determined that the appropriate form of relief
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`includes a limited exclusion order prohibiting the unlicensed entry of wearable electronic devices
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`with ECG functionality and components thereof that are manufactured abroad by or on behalf of,
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`or imported by or on behalf of, Respondent or any of its affiliated companies, parents,
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`subsidiaries, or other related business entities, or their successors or assigns.
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`The Commission has determined that the public interest factors enumerated in 19 U.S.C.
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`§ 1337(d)(1) do not preclude the issuance of the limited exclusion order, and that the bond
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`during the Presidential review period shall be in the amount of $2 per unit of covered articles
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`imported.
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`Accordingly, the Commission hereby ORDERS that:
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`1.
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`Wearable electronic devices with ECG functionality and components thereof that
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`infringe one or more of claims 12, 13, and 19-23 of the ’941 patent; and claims 1, 3, 5, 8-10, 12,
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`15, and 16 of the ’731 patent that are manufactured abroad by or on behalf of, or imported by or
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`on behalf of, Respondent or any of its affiliated companies, parents, subsidiaries, or other related
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`business entities, or their successors or assigns, are excluded from entry for consumption into the
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`United States, entry for consumption from a foreign trade zone, or withdrawal from a warehouse
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`for consumption, for the remaining terms of the patents, except under license of the patent owner
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`or as provided by law, and except for articles or components imported for use in servicing,
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`repairing, or replacing covered articles that were imported prior to the effective date of this Order
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`pursuant to existing service and warranty contracts.
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`2.
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`The wearable electronic devices with ECG functionality and components thereof
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`that are subject to this Order (“covered articles”) are as follows: Apple Watches with ECG
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`functionality, and hardware and software 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 $2 per unit of
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`covered articles imported pursuant to subsection (j) of section 337 (19 U.S.C. § 1337(j)) and the
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`Presidential Memorandum for the United States Trade Representative of July 21, 2005 (70 Fed.
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`Reg. 43,251), from the day after this Order is received by the United States Trade Representative
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`until such time as the United States Trade Representative notifies the Commission that this Order
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`is approved or disapproved but, in any event, not later than sixty (60) days after the date of
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`receipt of this Order. All entries of covered articles made pursuant to this paragraph are to be
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`reported to U.S. Customs and Border Protection (“CBP”), in advance of the date of the entry,
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`pursuant to procedures CBP establishes.
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`4.
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`The enforcement of this Order, including the bond provision, is suspended
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`pending final resolution of the U.S. Patent and Trademark Office, Patent Trial and Appeal
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`Board’s Final Written Decisions finding the asserted patent claims unpatentable. See Apple, Inc.
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`v. AliveCor, Inc., IPR2021-00971, Patent 10,595,731, Final Written Decision Determining All
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`Challenged Claims Unpatentable (Dec. 6, 2022); Apple, Inc. v. AliveCor, Inc., IPR2021-00972,
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`Patent 10,638,941, Final Written Decision Determining All Challenged Claims Unpatentable
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`(Dec. 6, 2022). See 35 U.S.C. § 318(b).
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`5.
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`At the discretion of CBP and pursuant to procedures that it establishes, persons
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`seeking to import articles that are potentially subject to this Order may be required to certify that
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`they are familiar with the terms of this Order, that they have made appropriate inquiry, and
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`thereupon state that, to the best of their knowledge and belief, the products being imported are
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`not excluded from entry under paragraph 1 of this Order. At its discretion, CBP may require
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`persons who have provided the certification described in this paragraph to furnish such records
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`or analyses as are necessary to substantiate the certification.
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`6.
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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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`7.
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`The Commission may modify this Order in accordance with the procedures
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`described in section 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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`8.
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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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`9.
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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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`Issued: December 22, 2022
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`Katherine M. Hiner
`Acting Secretary to the Commission
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