`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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`Inv. No. 337-TA-1266
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`NOTICE OF INSTITUTION OF INVESTIGATION
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`Institution of investigation pursuant to 19 U.S.C. 1337
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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 a complaint was filed with the U.S. International
`Trade Commission on April 20, 2021, under section 337 of the Tariff Act of 1930, as amended,
`on behalf of AliveCor, Inc. of Mountain View, California. The complaint alleges violations of
`section 337 based upon the importation into the United States, the sale for importation, and 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 claims of U.S.
`Patent No. 10,595,731 (“the ’731 patent”); U.S. Patent No. 10,638,941 (“the ’941 patent”); and
`U.S. Patent No. 9,572,499 (“the ’499 patent”). The complaint further alleges that an industry in
`the United States exists or is in the process of being established as required by the applicable
`Federal Statute.
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`The complainant requests that the Commission institute an investigation and, after the
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`investigation, issue a limited exclusion order and a cease and desist order.
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`ADDRESSES: The complaint, except for any confidential information contained therein, may
`be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. For help
`accessing EDIS, please email EDIS3Help@usitc.gov. Hearing impaired individuals are advised
`that information on this matter can be obtained by contacting the Commission’s TDD terminal
`on (202) 205-1810. Persons with mobility impairments who will need special assistance in
`gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000.
`General information concerning the Commission may also be obtained by accessing its internet
`server at https://www.usitc.gov.
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`FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of Unfair
`Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
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`SUPPLEMENTARY INFORMATION:
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`AUTHORITY: The authority for institution of this investigation is contained in section 337 of
`the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission’s
`Rules of Practice and Procedure, 19 C.F.R. 210.10 (2021).
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`SCOPE OF INVESTIGATION: Having considered the complaint, the U.S. International Trade
`Commission, on May 20, 2021, ORDERED THAT –
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`(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an
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`investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of
`section 337 in the importation into the United States, the sale for importation, or the sale within
`the United States after importation of certain products identified in paragraph (2) by reason of
`infringement of one or more of claims 1-30 of the ’731 patent; claims 1-23 of the ’941 patent;
`claims 1-4, 6-14, 16-20 of the ’499 patent, and whether an industry in the United States exists or
`is in the process of being established as required by subsection (a)(2) of section 337;
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`(2) Pursuant to section 210.10(b)(1) of the Commission’s Rules of Practice and
`Procedure, 19 C.F.R. 210.10(b)(1), the plain language description of the accused products or
`category of accused products, which defines the scope of the investigation, is “Apple Watches
`with ECG functionality, and hardware and software components thereof”;
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`(3) For the purpose of the investigation so instituted, the following are hereby named as
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`parties upon which this notice of investigation shall be served:
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`(a) The complainant is:
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`AliveCor, Inc.
`444 Castro St, Suite 600
`Mountain View, CA 94041
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`(b) The respondent is the following entity alleged to be in violation of section
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`337, and is the party upon which the complaint is to be served:
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`Apple, Inc.
`One Apple Park Way
`Cupertino, CA 95014
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`(c) The Office of Unfair Import Investigations, U.S. International Trade
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`Commission, 500 E Street, S.W., Suite 401, Washington, D.C. 20436; and
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`(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S.
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`International Trade Commission, shall designate the presiding Administrative Law Judge.
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`Responses to the complaint and the notice of investigation must be submitted by the
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`named respondent in accordance with section 210.13 of the Commission’s Rules of Practice and
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`Procedure, 19 C.F.R. 210.13. Pursuant to 19 C.F.R. 201.16(e) and 210.13(a), as amended in 85
`Fed. Reg. 15798 (March 19, 2020), such responses will be considered by the Commission if
`received not later than 20 days after the date of service by the complainant of the complaint and
`the notice of investigation. Extensions of time for submitting responses to the complaint and the
`notice of investigation will not be granted unless good cause therefor is shown.
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`Failure of the respondent to file a timely response to each allegation in the complaint and
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`in this notice may be deemed to constitute a waiver of the right to appear and contest the
`allegations of the complaint and this notice, and to authorize the administrative law judge and the
`Commission, without further notice to the respondent, to find the facts to be as alleged in the
`complaint and this notice and to enter an initial determination and a final determination
`containing such findings, and may result in the issuance of an exclusion order or a cease and
`desist order or both directed against the respondent.
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`By order of the Commission.
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`Issued: May 20, 2021
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`Lisa R. Barton
`Secretary to the Commission
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`3
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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
`
`Inv. No. 337-TA-1266
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`DESIGNATION OF OUII ATTORNEY
`FOR SERVICE OF PROCESS
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`The Office of Unfair Import Investigations (OUII) hereby designates Whitney
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`Winston, Esq. (202) 205-2221, whitney.winston@usitc.gov, as OUII’s lead attorney for
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`service of process. It is requested that all documents served by the Commission or filed by the
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`parties in the above-referenced investigation be served upon this attorney.
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`Respectfully submitted,
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`_________________________
`Margaret Macdonald, Director
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`OFFICE OF UNFAIR IMPORT INVESTIGATIONS
`U.S. International Trade Commission
`500 E Street, S.W., Suite 401
`Washington, D.C. 20436
`(202) 205-2560
`(202) 205-2158 (facsimile)
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`May 20, 2021
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`
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`Inv. No. 337-TA-1266
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`CERTAIN WEARABLE ELECTRONIC DEVICES
`WITH ECG CAPABILITY AND COMPONENTS
`THEREOF
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`Certificate of Service – Page 1
`PUBLIC CERTIFICATE OF SERVICE
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`I, Lisa R. Barton, hereby certify that the attached INSTITUTION OF
`INVESTIGATION has been served via EDIS upon the Commission Investigative Attorney,
`Whitney Winston, Esq., and the following parties as indicated, on May 20, 2021.
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`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
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`Complainant:
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`AliveCor, Inc.
`444 Castro Street
`Suite 600
`Mountain View, CA 94041
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Service to Be
`Completed by Complainant
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`☐ Via Hand Delivery
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`On Behalf of Complainant:
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`S. Alex Lasher, Esq.
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`1300 I Street NW, Suite 900
`Washington, DC 20005
`Email: alexlasher@quinnemanuel.com
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`Respondent:
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`Apple Inc.
`One Apple Park Way,
`Cupertino, CA 95014
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`Government Agencies:
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`Lynda Marshall
`International Section, Antitrust Division
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`CERTAIN WEARABLE ELECTRONIC DEVICES
`WITH ECG CAPABILITY AND COMPONENTS
`THEREOF
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`Certificate of Service – Page 2
`U.S. Department of Justice
`450 5th Street NW, Room 11000
`Washington, DC 20530
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`U.S. Bureau of Customs and Border Protection
`Intellectual Property Rights Branch
`Mint Annex Building
`799 9th Street, NW, 7th floor
`Washington, DC 20229
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`Elizabeth Kraus, Deputy Director
`International Antitrust, Office of International Affairs
`Federal Trade Commission
`600 Pennsylvania Avenue, Room 498
`Washington, DC 20580
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`Dale D. Berkley, Ph.D., J.D.
`Office of the General Counsel, PHD, NIH Branch
`National Institutes of Health
`31 Center Drive
`Bldg. 31, Rm. 47
`Bethesda, MD 20892
`
`
`Inv. No. 337-TA-1266
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`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`
`May 20, 2021
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` S. Alex Lasher
`Quinn Emanuel Urguhart & Sullivan, LLP
`1300 I Street NW, Suite 900
`Washington, DC 20005
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`Re: Certain Wearable Electronic Devices with ECG Capability and Components
`Thereof
`Inv. No. 337-TA-1266
`
`
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`Dear S. Alex Lasher:
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`This letter is to advise you that the U.S. International Trade Commission has instituted an
`investigation pursuant to section 337 of the Tariff Act of 1930 (19 U.S.C. 1337). A copy
`of the Commission's notice of investigation is enclosed. Also enclosed is the Section
`337 Mediation Program brochure. After reviewing the brochure, please sign and return
`the enclosed certification of receipt.
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`Sincerely,
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`Enclosures:
`1. Notice of Investigation
`2. Publication Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
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`Lisa R. Barton
`Secretary
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
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`May 20, 2021
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`AliveCor, Inc.
`444 Castro St, Suite 600
`Mountain View, CA 94041
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`Re: Certain Wearable Electronic Devices with ECG Capability and Components
`Thereof
`Inv. No. 337-TA-1266
`
`Dear Sir/Madam:
`
`This letter is to advise you that the U.S. International Trade Commission has instituted an
`investigation pursuant to section 337 of the Tariff Act of 1930 (19 U.S.C. 1337). A copy
`of the Commission's notice of investigation is enclosed. Also enclosed is the Section
`337 Mediation Program brochure. After reviewing the brochure, please sign and return
`the enclosed certification of receipt.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosures:
`1. Notice of Investigation
`2. Publication Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
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`
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`May 20, 2021
`
`Apple Inc.
`One Apple Park Way
`Cupertino, CA 95014
`Re: Certain Wearable Electronic Devices with ECG Capability and Components
` Thereof
`Inv. No. 337-TA-1266
`
`
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`Dear Sir/Madam:
`This letter is to advise you that the United States International Trade Commission has instituted
`an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C. 1337). Apple Inc.
`is a named respondent in this investigation.
`We are hereby serving you with a copy of the Complaint and the Notice of Investigation issued
`in this matter. Enclosed is a copy of the Code of Federal Regulations. Also enclosed is a the
`Section 337 Mediation Program brochure. After reviewing this brochure, please sign and return
`the enclosed certification of receipt.
`Please note that the Notice requires a response to the allegations in the Complaint and the
`response must be received not later than twenty (20) days after the date of service of the
`Complaint. Failure to file a response may result in inferences being drawn against your interests.
`Sincerely,
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``
`Enclosures:
`1. Complaint
`2. Notice of Investigation
`3. Code of Federal Regulation
`4. Publication Regarding the Section 337 Mediation Program
`5. Certification of Receipt of Mediation Materials
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`Lisa R. Barton
`Secretary
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
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`May 20, 2021
`
`
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`Lynda Marshall
`International Section
`Antitrust Division
`U.S. Dept of Justice
`450 5th Street NW, Room 11000
`Washington, DC 20530
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`Re: Certain Wearable Electronic Devices with ECG Capability and Components
`Thereof
`Inv. No. 337-TA-1266
`
`
`Dear Ms. Marshall:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
`
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`Sincerely,
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` Lisa R. Barton
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` Secretary
`Enclosure:
` 1. Notice of Investigation
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`
`May 20, 2021
`
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`Intellectual Property Rights Branch
`Regulations and Rulings
`Office of International Trade
`U.S. Customs and Border Protection
`90 K Street, NE, 10th floor
`Washington, DC 20229-1177
`
`Re: Certain Wearable Electronic Devices with ECG Capability and Components
`Thereof
`Inv. No. 337-TA-1266
`
`
`Dear Sir/Madam:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
`
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`Sincerely,
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` Lisa R. Barton
`
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` Secretary
`Enclosure:
` 1. Notice of Investigation
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
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`May 20, 2021
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`Elizabeth Kraus, Deputy Director
`International Antitrust, Office of
`International Affairs
`Federal Trade Commission
`600 Pennsylvania Avenue, Room 498
`Washington, DC 20580
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`Re: Certain Wearable Electronic Devices with ECG Capability and Components
`Thereof
`Inv. No. 337-TA-1266
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`Dear Ms. Kraus:
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`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
`
`Sincerely,
`
` Lisa R. Barton
`Secretary
`
`Enclosure:
`1. Notice of Investigation
`
`
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 20, 2021
`
`Dale D. Berkley, Ph.D., J.D.
`Office of the General Counsel, PHD, NIH Branch
`National Institutes of Health
`31 Center Drive
`Bldg. 31, Rm. 47
`Bethesda, MD 20892
`
`Re: Certain Wearable Electronic Devices with ECG Capability and Components
`Thereof
`Inv. No. 337-TA-1266
`
`Dear Mr. Berkley:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
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`Sincerely,
`
` Lisa R. Barton
`Secretary
`
`Enclosure:
`1. Notice of Investigation
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