[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58819-58821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20959]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1266]


Certain Wearable Electronic Devices With ECG Functionality and 
Components Thereof; 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

AGENCY: U.S. International Trade Commission.

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.

FOR FURTHER INFORMATION CONTACT: Panyin A. Hughes, Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 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 
[email protected]. 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 
on (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.\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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    \1\ The ALJ issued a corrected final ID on July 26, 2022, 
correcting the table of contents.
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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.
    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.
    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.
    (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

[[Page 58820]]

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)?
    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.
    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).
    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:
    (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.
    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.
    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.
    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.
    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.
    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 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.
    The Commission has determined to extend the target date to December 
12, 2022.
    The Commission vote for this determination took place on September

[[Page 58821]]

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 Practice and Procedure (19 
CFR part 210).

    By order of the Commission.
    Issued: September 22, 2022.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2022-20959 Filed 9-27-22; 8:45 am]
BILLING CODE 7020-02-P