CHAIRMAN
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C. 20436
`
`December 22, 2022
`
`The President
`The White House
`Washington, D.C. 20500
`
`Dear Mr. President:
`
`In accordance with subsection (j) of section 337 of the Tariff Act of 1930, as amended
`(19 U.S.C. § 1337) (“Section 337”), and the July 21, 2005 Memorandum for the United States
`Trade Representative (70 Fed. Reg. 43251), I am transmitting to you and the United States Trade
`Representative copies of the Commission’s limited exclusion order and cease and desist order, as
`described below, and the record upon which the Commission based its determination.
`
`On December 22, 2022, the United States International Trade Commission issued a
`limited exclusion order and a cease and desist order pursuant to Section 337 in USITC
`Investigation No. 337-TA-1266, Certain Wearable Electronic Devices with ECG Functionality
`and Components Thereof.
`
`The limited exclusion order prohibits Respondent Apple Inc., of Cupertino, California
`(“Apple”) from importing into the United States wearable electronic devices with ECG
`functionality and components thereof that infringe one or more of claims 12, 13, and 19-23 of
`U.S. Patent No. 10,638,941; and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S. Patent No.
`10,595,731 (“covered products”), except under license of the patent owner or as provided by law,
`and except for articles or components imported for use in servicing, repairing, or replacing
`covered articles that were imported prior to the effective date of this Order pursuant to existing
`service and warranty contracts. The cease and desist order prohibits Apple from further
`importing, selling, or distributing covered products in the United States.
`
`The Commission concluded that the statutory public interest factors enumerated in
`subsections (d)(1) and (f)(1) of Section 337 do not preclude the issuance of this remedy. The
`Commission determined that, during the period of Presidential review, the products described
`
`Confidential Removed SDB
`
`

`

`The President
`December 22, 2022
`page 2
`
`above, manufactured abroad or imported by, for, or on behalf of Apple, may be imported and
`sold in the United States with the posting a bond in the amount of $2 per unit imported.
`
`The Commission, however, has determined to suspend enforcement of the orders,
`including the bond provision, pending final resolution of the U.S. Patent and Trademark Office,
`Patent Trial and Appeal Board’s Final Written Decisions finding the asserted patent claims
`unpatentable. See 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).
`
`
`Sincerely,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`David S. Johanson
`Chairman
`
`Enclosures
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`CHAIRMAN
`
`
`
`
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C. 20436
`
`December 22, 2022
`
`The Honorable Janet L. Yellen
`Secretary of the Treasury
`Washington, D.C. 20220
`
`Dear Madame Secretary:
`
`In accordance with subsection (d) of Section 337 of the Tariff Act of 1930, as amended
`(19 U.S.C. § 1337) (“Section 337”), I am transmitting to you a copy of the Commission’s limited
`exclusion order, as described below, and the record upon which the Commission based its
`determination.
`
`On December 22, 2022, the United States International Trade Commission issued a
`limited exclusion order pursuant to Section 337 in USITC Investigation No. 337-TA-1266,
`Certain Wearable Electronic Devices with ECG Functionality and Components Thereof.
`
`The limited exclusion order prohibits Respondent Apple Inc., of Cupertino, California
`from importing into the United States wearable electronic devices with ECG functionality and
`components thereof that infringe one or more of claims 12, 13, and 19-23 of U.S. Patent No.
`10,638,941; and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S. Patent No. 10,595,731, except under
`license of the patent owner or as provided by law, and except for articles or components
`imported for use in servicing, repairing, or replacing covered articles that were imported prior to
`the effective date of this Order pursuant to existing service and warranty contracts.
`
`The Commission concluded that the statutory public interest factors enumerated in
`subsections (d)(1) of Section 337 do not preclude the issuance of this remedy. The Commission
`determined that, during the period of Presidential review, the products described above,
`manufactured abroad or imported by, for, or on behalf of Respondent Apple, may be imported
`and sold in the United States with the posting of a bond in the amount of $2 per unit imported.
`
`The Commission, however, has determined to suspend enforcement of the orders,
`including the bond provision, pending final resolution of the U.S. Patent and Trademark Office,
`
`

`

`Secretary Yellen
`December 22, 2022
`page 2
`
`Patent Trial and Appeal Board’s Final Written Decisions finding the asserted patent claims
`unpatentable. See 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).
`
`
`Sincerely,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`David S. Johanson
`Chairman
`
`Enclosures
`
`Dax Terrill, Chief
`Exclusion Order Enforcement
`Office of International Trade
`Regulation and Rulings
`U.S. Customs and Border Protection
`90 K Street, N.E.
`Washington, D.C. 20229-1177
`
`cc:
`
`
`
`

`

`CHAIRMAN
`
`
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`
`Washington, D.C. 20436
`
`December 22, 2022
`
`
`
`The Honorable Katherine Tai
`United States Trade Representative
`Washington, D.C. 20508
`
`Dear Ambassador Tai:
`
`In accordance with subsection (j) of Section 337 of the Tariff Act of 1930, as amended
`(19 U.S.C. § 1337) (“Section 337”), and the July 21, 2005, Memorandum for the United States
`Trade Representative (70 Fed. Reg. 43251), I am transmitting to you and the President copies of
`the Commission’s limited exclusion order and cease and desist order, as described below, and the
`record upon which the Commission based its determination.
`
`On December 22, 2022, the United States International Trade Commission issued a
`limited exclusion order and a cease and desist order pursuant to Section 337 in USITC
`Investigation No. 337-TA-1266, Certain Wearable Electronic Devices with ECG Functionality
`and Components Thereof.
`
`The limited exclusion order prohibits Respondent Apple Inc., of Cupertino, California
`(“Apple”) from importing into the United States wearable electronic devices with ECG
`functionality and components thereof that infringe one or more of claims 12, 13, and 19-23 of
`U.S. Patent No. 10,638,941; and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S. Patent No.
`10,595,731 (“covered products”), except under license of the patent owner or as provided by law,
`and except for articles or components imported for use in servicing, repairing, or replacing
`covered articles that were imported prior to the effective date of this Order pursuant to existing
`service and warranty contracts. The cease and desist order prohibits Apple from further
`importing, selling, or distributing covered products in the United States.
`
`The Commission concluded that the statutory public interest factors enumerated in
`subsections (d)(1) and (f)(1) of Section 337 do not preclude the issuance of this remedy. The
`Commission determined that, during the period of Presidential review, the products described
`
`

`

`Ms. Tai
`December 22, 2022
`page 2
`
`above, manufactured abroad or imported by, for, or on behalf of Apple, may be imported and
`sold in the United States with the posting of a bond in the amount of $2 per unit imported.
`
`The Commission, however, has determined to suspend enforcement of the orders,
`including the bond provision, pending final resolution of the U.S. Patent and Trademark Office,
`Patent Trial and Appeal Board’s Final Written Decisions finding the asserted patent claims
`unpatentable. See 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).
`
`
`Sincerely,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`David S. Johanson
`Chairman
`
`
`Enclosures
`
`cc:
`
`
`
`Shannon M. Nestor, Esq.
`Office of the General Counsel
`Office of the United States Trade Representative
`
`

`

`
`
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG FUNCTIONALITY
`AND COMPONENTS THEREOF
`
`
`
`
`
`
`Investigation No. 337-TA-1266
`
`
`
`
`
`
`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
`
`AGENCY: U.S. International Trade Commission.
`
`ACTION: Notice.
`
`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.
`
`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.
`
`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
`
`

`

`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.
`
`
`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).
`
`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.
`
`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.
`
`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.
`
`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,
`
`
`
`2
`
`

`

`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.
`
`The Commission has determined to deny Apple’s motion for leave to file a sur-reply to
`AliveCor’s reply submission.
`
`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.
`
`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.
`
`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).
`
`
`
`The Commission’s vote on this determination took place on December 22, 2022.
`
`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
`
`
`
`3
`
`

`

`Practice and Procedure (19 CFR 210).
`
`
`By order of the Commission.
`
` Issued: December 22, 2022
`
`Katherine M. Hiner
`Acting Secretary to the Commission
`
`
`
`
`
`4
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`
`
`In the Matter of
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG
`FUNCTIONALITY AND COMPONENTS
`THEREOF
`
`
`
`Investigation No. 337-TA-1266
`
`
`LIMITED EXCLUSION ORDER
`
`The United States International Trade Commission (“Commission”) has determined that
`
`
`
`there is a violation of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337), in
`
`the unlawful importation, sale for importation, or sale within the United States after importation
`
`by Apple Inc. (“Apple” or “Respondent”) of certain wearable electronic devices with ECG
`
`functionality and components thereof that infringe one or more of claims 12, 13, and 19-23 of
`
`U.S. Patent No. 10,638,941 (“the ’941 patent”); and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S.
`
`Patent No. 10,595,731 (“the ’731 patent”) (the ’941 and ’731 patents are collectively referred to
`
`herein as “the Asserted Patents”).
`
`Having reviewed the record in this investigation, including the written submissions of the
`
`parties and non-parties, the Commission has made its determination on the issues of remedy, the
`
`public interest, and bonding. The Commission has determined that the appropriate form of relief
`
`includes a limited exclusion order prohibiting the unlicensed entry of wearable electronic devices
`
`with ECG functionality and components thereof that are manufactured abroad by or on behalf of,
`
`or imported by or on behalf of, Respondent or any of its affiliated companies, parents,
`
`subsidiaries, or other related business entities, or their successors or assigns.
`
`The Commission has determined that the public interest factors enumerated in 19 U.S.C.
`
`§ 1337(d)(1) do not preclude the issuance of the limited exclusion order, and that the bond
`
`

`

`during the Presidential review period shall be in the amount of $2 per unit of covered articles
`
`imported.
`
`Accordingly, the Commission hereby ORDERS that:
`
`1.
`
`Wearable electronic devices with ECG functionality and components thereof that
`
`infringe one or more of 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 that are manufactured abroad by or on behalf of, or imported by or
`
`on behalf of, Respondent or any of its affiliated companies, parents, subsidiaries, or other related
`
`business entities, or their successors or assigns, are excluded from entry for consumption into the
`
`United States, entry for consumption from a foreign trade zone, or withdrawal from a warehouse
`
`for consumption, for the remaining terms of the patents, except under license of the patent owner
`
`or as provided by law, and except for articles or components imported for use in servicing,
`
`repairing, or replacing covered articles that were imported prior to the effective date of this Order
`
`pursuant to existing service and warranty contracts.
`
`2.
`
`The wearable electronic devices with ECG functionality and components thereof
`
`that are subject to this Order (“covered articles”) are as follows: Apple Watches with ECG
`
`functionality, and hardware and software components thereof.
`
`3.
`
`Notwithstanding paragraph 1 of this Order, covered articles are entitled to entry
`
`into the United States for consumption, entry for consumption from a foreign-trade zone, or
`
`withdrawal from a warehouse for consumption under bond in the amount of $2 per unit of
`
`covered articles imported pursuant to subsection (j) of section 337 (19 U.S.C. § 1337(j)) and the
`
`Presidential Memorandum for the United States Trade Representative of July 21, 2005 (70 Fed.
`
`Reg. 43,251), from the day after this Order is received by the United States Trade Representative
`
`until such time as the United States Trade Representative notifies the Commission that this Order
`
`is approved or disapproved but, in any event, not later than sixty (60) days after the date of
`2
`
`

`

`receipt of this Order. All entries of covered articles made pursuant to this paragraph are to be
`
`reported to U.S. Customs and Border Protection (“CBP”), in advance of the date of the entry,
`
`pursuant to procedures CBP establishes.
`
`4.
`
`The enforcement of this Order, including the bond provision, is suspended
`
`pending final resolution of the U.S. Patent and Trademark Office, Patent Trial and Appeal
`
`Board’s Final Written Decisions finding the asserted patent claims unpatentable. See 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). See 35 U.S.C. § 318(b).
`
`5.
`
`At the discretion of CBP and pursuant to procedures that it establishes, persons
`
`seeking to import articles that are potentially subject to this Order may be required to certify that
`
`they are familiar with the terms of this Order, that they have made appropriate inquiry, and
`
`thereupon state that, to the best of their knowledge and belief, the products being imported are
`
`not excluded from entry under paragraph 1 of this Order. At its discretion, CBP may require
`
`persons who have provided the certification described in this paragraph to furnish such records
`
`or analyses as are necessary to substantiate the certification.
`
`6.
`
`In accordance with 19 U.S.C. § 1337(l), the provisions of this Order shall not
`
`apply to covered articles that are imported by and for the use of the United States, or imported
`
`for, and to be used for, the United States with the authorization or consent of the Government.
`
`7.
`
`The Commission may modify this Order in accordance with the procedures
`
`described in section 210.76 of the Commission’s Rules of Practice and Procedure (19 C.F.R.
`
`§ 210.76).
`
`3
`
`

`

`8.
`
`The Secretary shall serve copies of this Order upon each party of record in this
`
`investigation that has retained counsel or otherwise provided a point of contact for electronic
`
`service and upon CBP.
`
`9.
`
`Notice of this Order shall be published in the Federal Register.
`
`By order of the Commission.
`
`
`Issued: December 22, 2022
`
`
`
`
`Katherine M. Hiner
`Acting Secretary to the Commission
`
`
`4
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`
`
`In the Matter of
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG
`FUNCTIONALITY AND COMPONENTS
`THEREOF
`
`
`
`Investigation No. 337-TA-1266
`
`
`CEASE AND DESIST ORDER
`
`IT IS HEREBY ORDERED THAT Apple Inc., of Cupertino, California, cease and
`
`
`
`desist from conducting any of the following activities in the United States: importing, selling,
`
`offering for sale, marketing, advertising, distributing, transferring (except for exportation),
`
`soliciting United States agents or distributors, and aiding or abetting other entities in the
`
`importation, sale for importation, sale after importation, transfer (except for exportation), or
`
`distribution of wearable electronic devices with ECG functionality and components thereof that
`
`infringe one or more of claims 12, 13, and 19-23 of U.S. Patent No. 10,638,941 (“the ’941
`
`patent”); and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S. Patent No. 10,595,731 (“the ’731
`
`patent”) (collectively, the “Asserted Patents”) in violation of section 337 of the Tariff Act of
`
`1930, as amended (19 U.S.C. § 1337).
`
`I.
`Definitions
`
`As used in this Order:
`
`(A)
`
`“Commission” shall mean the United States International Trade Commission.
`
`(B)
`
`“Complainant” shall mean AliveCor, Inc., of Mountain View, California.
`
`(C)
`
`“Respondent” shall mean Apple Inc., of Cupertino, California.
`
`

`

`
`
`(D)
`
`“Person” shall mean an individual, or any non-governmental partnership, firm,
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`association, corporation, or other legal or business entity other than Respondent or
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`its majority-owned or controlled subsidiaries, successors, or assigns.
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`(E)
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`“United States” shall mean the fifty States, the District of Columbia, and Puerto
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`Rico.
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`(F)
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`The terms “import” and “importation” refer to importation for entry for
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`consumption under the Customs laws of the United States.
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`(G)
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`The term “covered products” shall mean Certain Wearable Electronic Devices
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`with ECG Functionality and Components Thereof that infringe one or more of
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`claims 12, 13, and 19-23 of the ’941 patent; and claims 1, 3, 5, 8-10, 12, 15, and
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`16 of the ’731 patent. The Certain Wearable Electronic Devices with ECG
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`Functionality and Components Thereof subject to this order are as follows: Apple
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`Watches with ECG functionality, and hardware and software components thereof.
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`Covered products shall not include articles for which a provision of law or license
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`avoids liability for infringement.
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`II.
`Applicability
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`The provisions of this Cease and Desist Order shall apply to the Respondent and to any of
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`its principals, stockholders, officers, directors, employees, agents, distributors, controlled
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`(whether by stock ownership or otherwise) and majority-owned business entities, successors, and
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`assigns, and to each of them, insofar as they are engaging in conduct prohibited by section III,
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`infra, for, with, or otherwise on behalf of, Respondent.
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`2
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`III.
`Conduct Prohibited
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`The following conduct of Respondent in the United States is prohibited by this Order.
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`For the remaining terms of the Asserted Patents, Respondent shall not:
`
`(A)
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`import or sell for importation into the United States covered products;
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`(B) market, distribute, sell, offer to sell, or otherwise transfer (except for exportation)
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`(C)
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`(D)
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`(E)
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`in the United States imported covered products;
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`advertise imported covered products;
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`solicit U.S. agents or distributors for imported covered products; or
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`aid or abet other entities in the importation, sale for importation, sale after
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`importation, transfer (except for exportation), or distribution of covered products.
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`IV.
`Conduct Permitted
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`Notwithstanding any other provision of this Order, specific conduct otherwise prohibited
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`by the terms of this order shall be permitted:
`
`(A)
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`service, repair, or replacement of wearable electronic devices with ECG
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`functionality that were imported prior to the effective date of this Order pursuant
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`to existing service and warranty contracts,
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`(B)
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`if in a written instrument, the owner of the ’941 and ’731 patents licenses or
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`authorizes such specific conduct, or
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`(C)
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`if such specific conduct is related to the importation or sale of covered products
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`by or for the United States.
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`The enforcement of this Order, including the bond provision, is suspended pending final
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`resolution of the U.S. Patent and Trademark Office, Patent Trial and Appeal Board’s Final
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`Written Decisions finding the asserted patent claims unpatentable. See Apple, Inc. v. AliveCor,
`
`Inc., IPR2021-00971, Patent 10,595,731, Final Written Decision Determining All Challenged
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`Claims Unpatentable (Dec. 6, 2022); Apple, Inc. v. AliveCor, Inc., IPR2021-00972, Patent
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`10,638,941, Final Written Decision Determining All Challenged Claims Unpatentable (Dec. 6,
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`2022). See 35 U.S.C. § 318(b).
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`V.
`Reporting
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`For purposes of this requirement, the reporting periods shall commence on July 1 of each
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`year and shall end on the subsequent June 30. The first report required under this section shall
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`cover the period from the date of issuance of this order through June 30, 2023. This reporting
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`requirement shall continue in force until such time as Respondent has truthfully reported, in two
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`consecutive timely filed reports, that it has no inventory of covered products in the United States.
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`Within thirty (30) days of the last day of the reporting period, Respondent shall report to
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`the Commission (a) the quantity in units and the value in dollars of covered products that it has
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`(i) imported and/or (ii) sold in the United States after importation during the reporting period,
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`and (b) the quantity in units and value in dollars of reported covered products that remain in
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`inventory in the United States at the end of the reporting period.
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`When filing written submissions, Respondent must file the original document
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`electronically on or before the deadlines stated above. Submissions should refer to the
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`investigation number (“Inv. No. 337-TA-1266”) in a prominent place on the cover pages and/or
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`the first page. (See Handbook for Electronic Filing Procedures,
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`http://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf).
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`Persons with questions regarding filing should contact the Secretary (202-205-2000). If
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`Respondent desires to submit a document to the Commission in confidence, it must file the
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`original and a public version of the original with the Office of the Secretary and must serve a
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`copy of the confidential version on Complainant’s counsel.1
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`Any failure to make the required report or the filing of any false or inaccurate report shall
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`constitute a violation of this Order, and the submission of a false or inaccurate report may be
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`referred to the U.S. Department of Justice as a possible criminal violation of 18 U.S.C. § 1001.
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`VI.
`Record-Keeping and Inspection
`
`(A)
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`For the purpose of securing compliance with this Order, Respondent shall retain
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`any and all records relating to the sale, marketing, or distribution in the United
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`States of covered products, made and received in the usual and ordinary course of
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`business, whether in detail or in summary form, for a period of three (3) years
`
`from the close of the fiscal year to which they pertain.
`
`(B)
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`For the purposes of determining or securing compliance with this Order and for
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`no other purpose, subject to any privilege recognized by the federal courts of the
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`United States, and upon reasonable written notice by the Commission or its staff,
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`duly authorized representatives of the Commission shall be permitted access and
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`the right to inspect and copy, in Respondent’s principal offices during office
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`1 Complainant mu