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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 WEARABLE ELECTRONIC
`DEVICES WITH ECG FUNCTIONALITY
`AND COMPONENTS THEREOF
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`Investigation No. 337-TA-1266
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`NOTICE OF THE COMMISSION’S FINAL DETERMINATION FINDING A
`VIOLATION OF SECTION 337; ISSUANCE AND SUSPENSION OF A LIMITED
`EXCLUSION ORDER AND A CEASE AND DESIST ORDER; TERMINATION OF THE
`INVESTIGATION
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`AGENCY: U.S. International Trade Commission.
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`ACTION: Notice.
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`SUMMARY: Notice is hereby given that the U.S. International Trade Commission
`(“Commission”) has determined that there is a violation of section 337 in the above-captioned
`investigation. The Commission has further determined to issue a limited exclusion order and a
`cease and desist order and to set a bond in the amount of $2 per unit of covered articles imported
`or sold during the period of Presidential review. The enforcement of these orders, including the
`bond provision, is suspended pending final resolution of the U.S. Patent and Trademark Office,
`Patent Trial and Appeal Board’s (“PTAB”) Final Written Decisions finding the asserted patent
`claims unpatentable.
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`FOR FURTHER INFORMATION CONTACT: Panyin A. Hughes, Office of the General
`Counsel, U.S. International Trade Commission, 500 E Street, S.W., Washington, D.C. 20436,
`telephone (202) 205-3042. 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 EDIS3Help@usitc.gov. 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, telephone (202) 205-1810.
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`SUPPLEMENTARY INFORMATION: On May 26, 2021, the Commission instituted this
`investigation based on a complaint filed by AliveCor, Inc. of Mountain View, California
`(“AliveCor”). 86 FR 28382 (May 26, 2021). The complaint alleged violations of section 337
`based on the importation into the United States, the sale for importation, or the sale within the
`United States after importation of certain wearable electronic devices with ECG functionality
`and components thereof by reason of infringement of one or more of claims 1-30 of U.S. Patent
`No. 10,595,731 (“the ’731 patent”); claims 1-23 of U.S. Patent No. 10,638,941 (“the ’941
`patent”); and claims 1-4, 6-14, 16-20 of U.S. Patent No. 9,572,499 (“the ’499 patent”). Id. The
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`Commission’s notice of investigation named Apple Inc. of Cupertino, California (“Apple”) as
`the sole respondent. The Office of Unfair Import Investigations (“OUII”) is named as a party in
`this investigation. Id.
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`On February 23, 2022, the ALJ issued an initial determination granting AliveCor’s
`motion to terminate the investigation as to (1) claims 1-4, 6-14, and 18-20 of the ’499 patent; (2)
`claims 2, 4, 6, 7, 11, 13, 14, and 17-30 of the ’731 patent; and (3) claims 1-11, 14, 15, 17, and 18
`of the ’941 patent based upon withdrawal of allegations from the complaint as to those claims.
`Order No. 16 (Feb. 23, 2022), unreviewed by Notice (Mar. 18, 2022).
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`On June 27, 2022, the ALJ issued the final initial determination (“ID”) finding a violation
`of section 337 as to the ’941 and ’731 patents, and no violation of section 337 as to the ’499
`patent. The ID found that the parties do not contest personal jurisdiction and that the
`Commission has in rem jurisdiction over the accused products. ID at 18. The ID further found
`that the importation requirement under 19 U.S.C. 1337(a)(1)(B) is satisfied. Id. (citing CX-
`0904C (Apple stipulating that it imports the accused products into the United States)).
`Regarding the ’941 patent, the ID found that AliveCor has proven infringement of the asserted
`claims, claims 12, 13, 19, and 20-23, and that Apple failed to show that any of the asserted
`claims are invalid. Id. at 30-45, 60-98. For the ’731 patent, the ID found that AliveCor has
`proven infringement of the asserted claims, claims 1, 3, 5, 8-10, 12, 15, and 16, but that Apple
`has proven that claims 1, 8, 12, and 16 are invalid for obviousness. Id. at 105-108, 113-127. For
`the ’499 patent, the ID found that AliveCor failed to prove infringement of the asserted claims,
`claims 16 and 17, and that claim 17 is invalid for lack of patentable subject matter under 35
`U.S.C. 101. Id. at 129-138, 140-152. Finally, the ID found that AliveCor has proven the
`existence of a domestic industry that practices the asserted patents as required by 19 U.S.C.
`1337(a)(2). Id. at 152-183. The ID included the ALJ’s recommended determination on remedy
`and bonding (“RD”). The RD recommended that, should the Commission find a violation,
`issuance of a limited exclusion order and a cease and desist order would be appropriate. ID/RD
`at 190-193. The RD also recommended imposing no bond for covered products imported during
`the period of Presidential review. ID at 193-95.
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`On July 11, 2022, Apple filed a petition for review of the ID, and AliveCor filed a
`combined petition and contingent petition for review of the ID. On July 19, 2022, the private
`parties and OUII’s investigative attorney filed responses to the petitions.
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`On September 22, 2022, the Commission determined to review the final ID in part. 87
`Fed. Reg. 58819-21 (Sept. 28, 2022). Specifically, the Commission determined to review the
`final ID’s invalidity findings, including patent eligibility under 35 U.S.C. 101 and obviousness
`under 35 U.S.C. 103, and the economic prong of the domestic industry requirement for all three
`patents. Id. The Commission requested briefing from the parties on certain issues under review.
`The Commission requested briefing from the parties, interested government agencies, and
`interested persons on remedy, the public interest, and bonding. Id.
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`On October 6, 2022, the parties filed initial submissions in response to the Commission’s
`request for briefing. On October 14, 2022, the parties filed reply submissions. On October 21,
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`2022, Apple moved for leave to file a sur-reply to AliveCor’s reply submission. On October 24,
`2022, AliveCor filed an opposition. OUII filed a response in opposition on November 2, 2022.
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`The Commission has determined to deny Apple’s motion for leave to file a sur-reply to
`AliveCor’s reply submission.
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`On December 7, 2022, Apple filed an emergency motion, asking “the Commission to
`suspend any remedial orders or, in the alternative, extend the December 12, 2022 Target Date of
`its Final Determination and stay all proceedings prior to issuance of any Final Determination
`pending final resolution of any appeal of the PTAB’s decisions” finding the asserted patent
`claims unpatentable. Apple Emergency Motion at 1. On December 9, 2022, AliveCor filed an
`opposition to Apple’s motion. On December 16, 2022, OUII filed a response in support of
`Apple’s motion, but only to the extent that any remedy the Commission issues be suspended
`pending appeal of the PTAB decisions. OUII Reply to Emergency Motion at 4.
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`Upon review of the parties’ submissions, the ID, the RD, evidence of record, and public
`interest filings, the Commission has determined that Apple violated section 337 by reason of
`importation and sale of articles that infringe asserted claims 12, 13, and 19-23 of the ’941 patent;
`and claims 1, 3, 5, 8-10, 12, 15, and 16 of the ’731 patent. Regarding the issues under review,
`the Commission has determined to affirm the ID’s economic prong of the domestic industry
`findings with the modifications described in the accompanying Commission opinion.
`Concerning invalidity, the Commission has determined to affirm the ID’s patent eligibility
`findings under 35 U.S.C. 101 as to one claim with modifications explained in the Commission
`opinion and reverse as to another; and to correct the ID for not considering objective indicia of
`non-obviousness for certain asserted claims. For remedy, the Commission has determined to
`issue a limited exclusion order prohibiting further importation of infringing products and a cease
`and desist order against Apple. The Commission has determined that the public interest factors
`do not counsel against issuing remedial orders. The Commission has determined that a bond in
`the amount of $2 per unit of covered articles is required for covered products imported or sold
`during the period of Presidential review.
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`The enforcement of these orders, including the bond provision, is suspended pending
`final resolution of the PTAB’s Final Written Decisions finding the asserted patent claims
`unpatentable. See 35 U.S.C. 318(b); Apple, Inc. v. AliveCor, Inc., IPR2021-00971, Patent
`10,595,731, Final Written Decision Determining All Challenged Claims Unpatentable (Dec. 6,
`2022); Apple, Inc. v. AliveCor, Inc., IPR2021-00972, Patent 10,638,941, Final Written Decision
`Determining All Challenged Claims Unpatentable (Dec. 6, 2022).
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`The Commission’s vote on this determination took place on December 22, 2022.
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`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
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`Practice and Procedure (19 CFR 210).
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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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