Notice2023-10701
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
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Published
May 19, 2023
Issuing agencies
International Trade Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 97 (Friday, May 19, 2023)</title>
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[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Notices]
[Pages 32243-32246]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#5d1819140e6e1538312d1d282e34293e733a322b"><span class="__cf_email__" data-cfemail="783d3c312b4b301d1408380d0b110c1b561f170e">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. 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)
[[Page 32246]]
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, <a href="https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf">https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf</a>). 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
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