[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Notices]
[Pages 32243-32246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10701]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1276]


Certain Light-Based Physiological Measurement Devices and 
Components Thereof; Notice of a Commission Determination To Review in 
Part a Final Initial Determination; Request for Written Submissions on 
the Issues Under Review and on Remedy, the Public Interest, and Bonding

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. The Commission 
requests written submissions from the parties on the issues under 
review and submissions 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: Ron Traud, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone 202-205-3427. 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: The Commission instituted this investigation 
on August 18, 2021, based on a complaint filed on behalf of Masimo 
Corporation and Cercacor Laboratories, Inc., both of Irvine, CA 
(collectively, ``Complainants''). 86 FR 46275 (Aug. 18, 2021). The 
complaint, as amended, alleged violations of section 337 of the Tariff 
Act of 1930, as amended, 19 U.S.C. 1337, based upon the importation 
into the United States, the sale for importation, and the sale within 
the United States after importation of certain light-based 
physiological measurement devices and components

[[Page 32244]]

thereof by reason of infringement of certain claims of U.S. Patent No. 
10,912,501 (``the '501 patent''), U.S. Patent No. 10,912,502 (``the 
'502 patent''), U.S. Patent No. 10,945,648 (``the '648 patent''), U.S. 
Patent No. 10,687,745 (``the '745 patent''), and U.S. Patent No. 
7,761,127 (``the '127 patent''). Id. The amended complaint further 
alleged that an industry in the United States exists and/or is in the 
process of being established as required by section 337. Id. The notice 
of investigation named Apple Inc. of Cupertino, CA (``Apple'') as a 
respondent. Id. at 46276. The Office of Unfair Import Investigations is 
not participating in this investigation. Id.
    Complainants previously withdrew certain asserted claims pursuant 
to Order No. 25 (Mar. 23, 2022), unreviewed by Comm'n Notice (Apr. 12, 
2022), and Order No. 33 (May 20, 2022), unreviewed by Comm'n Notice 
(June 10, 2022). Only claim 12 of the '501 patent, claims 22 and 28 of 
the '502 patent, claims 12, 24, and 30 of the '648 patent, claims 9 and 
27 of the '745 patent, and claim 9 of the '127 patent remain in the 
investigation. Claim 18 of the '745 patent is still at issue for 
purposes of the domestic industry.
    On January 10, 2023, the ALJ issued the Final ID, which found that 
Apple violated section 337 as to claims 24 and 30 of the '648 patent, 
but not as to claim 12 of the '501 patent, claims 22 and 28 of the '502 
patent, claim 12 of the '648 patent, claims 9 and 27 of the '745 
patent, and claim 9 of the '127 patent. See Final ID at 335-36. On 
January 24, 2023, the ALJ issued a Recommended Determination on remedy 
and bonding (``RD'') should a violation be found in the above-captioned 
investigation. The RD recommended that, if the Commission finds a 
violation, it should issue a limited exclusion order directed to 
certain wearable electronic devices with light-based pulse oximetry 
functionality and components thereof that are imported, sold for 
importation, and/or sold after importation by Apple; and a cease and 
desist order directed to Apple. RD at 2, 5. The RD found the record did 
not support Apple's request for an exemption for service and repair. 
Id. at 2-3. The RD additionally recommended that the Commission set a 
zero percent (0%) bond (i.e., no bond) during the sixty-day period of 
Presidential review. Id. at 6.
    On January 23, 2023, Complainants and Apple each filed a petition 
for review. On January 31, 2023, Complainants and Apple each filed 
responses to the respective petitions. On February 23, 2023, the 
parties filed their public interest statements pursuant to 19 CFR 
210.50(a)(4). The Commission received numerous comments on the public 
interest from non-parties.
    Having reviewed the record of the investigation, including the 
Final ID, the parties' submissions to the ALJ, and the petitions and 
responses thereto, the Commission has determined to review the Final ID 
in part. Specifically, the Commission has determined to review (1) the 
domestic industry with regard to the'501 patent, the '502 patent, the 
'648 patent, and the '745 patent; (2) obviousness with regard to 
the'501 patent, the '502 patent, the '648 patent, and the '745 patent; 
(3) written description with regard to claim 28 of the '502 patent and 
claim 12 of the '648 patent; (4) claim construction and infringement 
with regard to the '745 patent; and (5) subject matter jurisdiction. 
The Commission has determined not to review the remaining findings of 
the Final ID, including the finding of no violation as to the '127 
patent. The Commission notes that on pages 282-83 of the Final ID, in 
the section entitled ``Element[9]: `a thermistor,''' the ALJ refers to 
claim 1 as the independent claim from which claim 9 depends. The 
Commission understands that reference to be a typographical error and 
notes that the reference should be to claim 7.
    In connection with its review, the Commission requests responses to 
the following questions. The parties are requested to brief their 
positions with reference to the applicable law and the existing 
evidentiary record.
    (1) What evidence and argument was presented to the ALJ that shows 
that Complainants were developing, as of the filing of the Complaint, 
the Masimo Watch and that the Masimo Watch would practice the Poeze and 
`745 patent claims?
    (2) Should the Commission consider evidence post-dating the 
Complaint, such as the final design of the Masimo Watch, to establish 
that Complainants were developing a physical article that would 
practice the Poeze patents and the '745 patent?
    (3) If the Commission considers the Masimo Watch to be a domestic 
industry product in the process of being established for the Poeze 
patents and the '745 patent, what investments and activities should the 
Commission consider in its analysis?
    (4) What should be considered as a domestic industry product for 
purposes of an industry in the process of being established--the Rev 
Sensor products, the Masimo Watch or both? What activities and 
investments should be considered toward satisfying the domestic 
industry requirement with respect to that DI product(s)? Was it 
appropriate to consider investments related to the Circle and Wing 
Sensors (assuming they are not shown to practice the Poeze patents or 
the `745 patent prior to the filing of the Complaint) leading to the 
development of the Rev Sensor products, in finding that a domestic 
industry exists or is in the process of being established for the Poeze 
and `745 patents? See ID at 301-24. If the Masimo Watch is a DI product 
for an industry in the process of being established, would it be 
appropriate to consider activities and investments in products (that 
themselves do not practice the Poeze patents prior to the filing of the 
Complaint) that contributed to the development of the Masimo Watch? 
What investments were made for the Circle sensor, Wing sensor, and 
Masimo Watch prior to the Complaint being filed and what investments 
were made after? Should the Commission consider investments made after 
the Complaint was filed?
    (5) Should recruiting labor expenditures be considered to 
contribute towards the satisfaction of the economic prong?
    (6) Should executive labor expenditures generally, and executive 
legal labor expenditures specifically, be considered to contribute 
towards the satisfaction of the economic prong? How closely does their 
work have to be connected to the domestic industry product to be 
included? With respect to the executive labor included in the Final 
ID's analysis of a domestic industry (see ID at 311-313), what evidence 
shows the extent to which the executives' work was connected to the 
domestic industry product?
    (7) Is there a statutory basis for considering only certain types 
of labor expenses with respect to articles protected by the asserted 
patent for purposes of satisfaction of the domestic industry 
requirement under section 337(a)(3)(B)?
    (8) Is there a legislative history or caselaw basis for considering 
only certain types of labor expenses with respect to articles protected 
by the asserted patent for purposes of satisfaction of the domestic 
industry requirement under section 337(a)(3)(B)?
    (9) Does Figure 7B in the Poeze Patents show two emitters, each 
labeled 104, where each emitter has LEDs that can emit light at or 
about 1610 nm, about 1640 nm, and about 1665 nm? Was Complainants' 
argument regarding 37 CFR 1.84(p)(4) raised in front of the ALJ, and if 
not, can the Commission still consider the argument? Is 37 CFR 
1.84(p)(4) binding authority on the Commission and does it require the

[[Page 32245]]

Commission to presume that each emitter set 104 is identical? If so, is 
that disclosure in Figure 7B sufficient to convey with reasonable 
clarity to those skilled in the art that, as of the filing date, the 
inventor was in possession of two sets of LEDs each with ``an LED 
configured to emit light at a first wavelength and an LED configured to 
emit light at a second wavelength?''
    The parties are invited to brief only the discrete issues requested 
above. 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 respondents 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 addition, the Commission requests specific briefing to address 
the following questions relevant to the public interest considerations 
in this investigation, and responses are encouraged to include evidence 
in support of their statements:
    (1) Please identify any ongoing or formally planned studies that 
use the blood oxygen features of the Apple Watches. Should the 
Commission allow an exemption or delay the effective date of any 
remedial relief so as to permit importation of the infringing Apple 
Watches for purposes of conducting such studies? Please explain the 
rationale and the scope of any such exemption or delay.
    (2) How should the Commission define a reasonable substitute for 
the infringing Apple Watches?
    (3) Please identify whether any reasonable substitutes for the 
infringing Apple Watches are available to consumers and whether they 
are capable of meeting any public health and welfare concerns raised by 
any remedial relief in this investigation. Is or would there be 
sufficient supply of any such reasonable substitutes for the infringing 
Apple Watches? Is the Masimo W1 watch a reasonable substitute and to 
what extent would supply of these products be available to fill the 
demand?
    (4) Please explain how easily the infringing features of the Apple 
Watches could be removed and whether Apple is working on any redesigns 
with respect to the infringing features and how long implementation of 
any redesigns would take?
    (5) Is there any production of like or directly competitive 
products in the United States and how would such production be impacted 
by any remedial relief?
    (6) Should the Commission include an exemption for repair and/or 
replacement of broken products impacted pursuant to any potential 
remedy, and if so, should the exemption only apply under warranty? If a 
repair and/or replacement exemption is included, should the cutoff date 
for repair and replacement be the date of the Order or the date the 
Order becomes final within the meaning of 19 U.S.C. 1337(j)(4)? See 
Certain Fitness Devices, Streaming Components Thereof, and Systems 
Containing Same, Inv. No. 337-TA-1265, Comm'n Op. at 88-92 (Mar. 23, 
2023) (Public Version); Certain Robotic Floor Cleaning Devices and 
Components Thereof, Inv. No. 337-TA-1252, Comm'n Op. at 76-82 (Apr. 13, 
2023) (Public Version). Should the exemption apply to products imported 
prior to the cutoff date or only to products sold to an end user as of 
the cutoff date? Should the exemption cover only parts for repair, or 
should it permit replacement of entire units? Please cite and discuss 
the evidence of record relevant to whether the Commission should 
include a repair and/or replacement exemption.
    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 issues 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. Such 
submissions should address the RD by the ALJ on remedy and bonding.
    In its initial submission, Complainants are also requested to 
identify the remedy sought and are requested to submit proposed 
remedial orders for the Commission's consideration. Complainants are 
also requested to identify and explain, from the record, articles that 
it contends are ``components thereof'' of the subject products, and 
thus potentially covered by the proposed remedial orders, if imported 
separately from the subject products. See 86 FR 46275-76. Failure to 
provide this information may result in waiver of any remedy directed to 
``components thereof'' the subject products, in the event any violation 
may be found. Complainants are 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 June 5, 2023. Reply submissions must be filed no 
later than the close of business on June 12, 2023. No further 
submissions on these issues will be permitted unless otherwise ordered 
by the Commission. Opening submissions are limited to 100 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)

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are currently waived. 85 FR 15798 (March 19, 2020). Submissions should 
refer to the investigation number (Inv. No. 337-TA-1276) 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 vote for this determination took place on May 15, 
2023.
    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: May 15, 2023.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2023-10701 Filed 5-18-23; 8:45 am]
BILLING CODE 7020-02-P