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 A COMMISSION DETERMINATION TO REVIEW IN PART A FINAL
`INITIAL DETERMINATION FINDING A VIOLATION OF SECTION 337; REQUEST
`FOR WRITTEN SUBMISSIONS ON THE ISSUES UNDER REVIEW AND ON
`REMEDY, THE PUBLIC INTEREST, AND BONDING; EXTENSION OF THE
`TARGET DATE
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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 to review in part a final initial determination (“ID”) of the
`presiding administrative law judge (“ALJ”), finding a violation of section 337 as to two of the
`three asserted patents. The Commission requests written submissions from the parties on the
`issues under review and from the parties, interested government agencies, and other interested
`persons on the issues of remedy, the public interest, and bonding, under the schedule set forth
`below.
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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.1 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 cease and desist orders 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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`Having reviewed the record of the investigation, including the final ID, the parties’
`submissions to the ALJ, the petitions for review, and the responses thereto, the Commission has
`determined to review the ID in part. Specifically, the Commission has 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.
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`In connection with its review, the Commission requests responses from the parties to the
`following questions. The parties are requested to brief their positions with reference to the
`applicable law and the existing evidentiary record.
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`1 The ALJ issued a corrected final ID on July 26, 2022, correcting the table of contents.
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`(1) Discuss whether the record evidence of “industry praise” and “copying” is sufficient
`to establish the requisite objective indicia of non-obviousness. See Graham v. John
`Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966).
`(2) Please explain whether and how the Complainant’s investments credited by the ID
`under subsection 337(a)(3)(B) are quantitatively and qualitatively significant.
`(3) Please explain whether and how the Complainant’s employment of labor in research
`and development in the exploitation of the patents under subsection 337(a)(3)(C) are
`quantitatively and qualitatively substantial. Please state whether the R&D contract
`labor amount credited by the ID under subsection 337(a)(3)(C) includes foreign
`contract labor and, if so, please quantify such included amounts.
`(4) What is the factual and legal basis for crediting Complainant’s investments in the
`KBP and PRD products toward satisfaction of the domestic industry requirement
`under subsection (C)?
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`The parties are invited to brief only these discrete questions. The parties are not to brief other
`issues on review, which are adequately presented in the parties’ existing filings.
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`In connection with the final disposition of this investigation, the statute authorizes
`issuance of, inter alia, (1) an exclusion order that could result in the exclusion of the subject
`articles from entry into the United States; and/or (2) cease and desist orders that could result in
`the respondent being required to cease and desist from engaging in unfair acts in the importation
`and sale of such articles. Accordingly, the Commission is interested in receiving written
`submissions that address the form of remedy, if any, that should be ordered. If a party seeks
`exclusion of an article from entry into the United States for purposes other than entry for
`consumption, the party should so indicate and provide information establishing that activities
`involving other types of entry either are adversely affecting it or likely to do so. For background,
`see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360,
`USITC Pub. No. 2843, Comm’n Op. at 7-10 (Dec. 1994).
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`The statute requires the Commission to consider the effects of that remedy upon the
`public interest. The public interest factors the Commission will consider include the effect that
`an exclusion order and cease and desist orders would have on: (1) the public health and welfare,
`(2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or
`directly competitive with those that are subject to investigation, and (4) U.S. consumers. The
`Commission is therefore interested in receiving written submissions that address the
`aforementioned public interest factors in the context of this investigation. In particular, the
`Commission requests that the parties, interested government agencies, and interested persons
`respond to the following:
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`(1) Please provide information and argument that responds to the statements on the
`public interest submitted on the public record by the parties and the various third
`parties.
`(2) Please provide data and factual information that specifically addresses whether and to
`what extent each of the four public interest factors would be adversely impacted by
`the remedial orders recommended in the RD, including details regarding the extent to
`which alternatives to the infringing products would be available to replace the
`infringing products and address the public health and welfare concerns raised.
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`If the Commission orders some form of remedy, the U.S. Trade Representative, as
`delegated by the President, has 60 days to approve, disapprove, or take no action on the
`Commission’s determination. See Presidential Memorandum of July 21, 2005, 70 FR 43251
`(July 26, 2005). During this period, the subject articles would be entitled to enter the United
`States under bond, in an amount determined by the Commission and prescribed by the Secretary
`of the Treasury. The Commission is therefore interested in receiving submissions concerning the
`amount of the bond that should be imposed if a remedy is ordered.
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`WRITTEN SUBMISSIONS: The parties to the investigation are requested to file written
`submissions on the questions identified in this notice. Parties to the investigation, interested
`government agencies, and any other interested parties are encouraged to file written submissions
`on the issues of remedy, the public interest, and bonding and to provide factual information and
`data requested above with respect to the public interest, including responding to the submissions
`of the parties and third parties that are in the record of this investigation. Such submissions
`should address the recommended determination by the ALJ on remedy and bonding.
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`In its initial submission, Complainant is also requested to identify the remedy sought and
`Complainant and OUII are requested to submit proposed remedial orders for the Commission’s
`consideration. Complainant is further requested to provide the HTSUS subheadings under which
`the accused products are imported, and to supply the identification information for all known
`importers of the products at issue in this investigation. The initial written submissions and
`proposed remedial orders must be filed no later than close of business on October 6, 2022.
`Reply submissions must be filed no later than the close of business on October 13, 2022. No
`further submissions on these issues will be permitted unless otherwise ordered by the
`Commission. Opening submissions are limited to 75 pages. Reply submissions are limited to 50
`pages. No further submissions on any of these issues will be permitted unless otherwise ordered
`by the Commission.
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`Persons filing written submissions must file the original document electronically on or
`before the deadlines stated above. The Commission’s paper filing requirements in 19 CFR
`210.4(f) are currently waived. 85 FR 15798 (March 19, 2020). Submissions should refer to the
`investigation number (Inv. No. 337-TA-1266) in a prominent place on the cover page and/or the
`first page. (See Handbook for Electronic Filing Procedures,
`https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). Persons with questions
`regarding filing should contact the Secretary, (202) 205-2000.
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`Any person desiring to submit a document to the Commission in confidence must request
`confidential treatment by marking each document with a header indicating that the document
`contains confidential information. This marking will be deemed to satisfy the request procedure
`set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for
`which confidential treatment by the Commission is properly sought will be treated accordingly.
`Any non-party wishing to submit comments containing confidential information must serve
`those comments on the parties to the investigation pursuant to the applicable Administrative
`Protective Order. A redacted non-confidential version of the document must also be filed with
`the Commission and served on any parties to the investigation within two business days of any
`confidential filing. All information, including confidential business information and documents
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`for which confidential treatment is properly sought, submitted to the Commission for purposes of
`this investigation may be disclosed to and used: (i) by the Commission, its employees and
`Offices, and contract personnel (a) for developing or maintaining the records of this or a related
`proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the
`programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or
`(ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes.
`All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential
`written submissions will be available for public inspection on EDIS.
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`The Commission has determined to extend the target date to December 12, 2022.
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`The Commission vote for this determination took place on September 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
`Practice and Procedure (19 CFR Part 210).
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`By order of the Commission.
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`Issued: September 22, 2022
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`Katherine M. Hiner
`Acting Secretary to the Commission
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