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, 32243-32246 [2023-10701]
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Atlantic City, New Jersey, or the
Monmouth County landfall site in Sea
Girt, New Jersey, or both. Project 1
proposes to produce 1,510 MW. The
MW for Project 2 has not been
determined as Atlantic Shores is still
seeking an offtake power agreement for
Project 2.
Alternatives: BOEM considered 21
alternatives when preparing the DEIS
and carried forward 6 alternatives for
further analysis in the DEIS. These 6
alternatives include 5 action alternatives
and the no action alternative. BOEM did
not analyze in detail 15 of the 21
alternatives because they did not meet
the purpose and need for the proposed
action or did not meet screening criteria,
which are presented in chapter 2 of the
DEIS. The screening criteria included
consistency with law and regulations,
technical and economic feasibility,
environmental impact, and geographic
considerations.
Availability of the DEIS: The DEIS,
COP, and associated information are
available on BOEM’s website at: https://
www.boem.gov/renewable-energy/stateactivities/atlantic-shores-south. BOEM
has distributed digital copies of the
DEIS to all parties listed in appendix M
of the DEIS, which also includes the
location of all libraries receiving a copy.
If you require a digital copy on a flash
drive or paper copy, BOEM will provide
one upon request, if supplies are
available. You may request a flash drive
or paper copy of the DEIS by contacting
Kimberly Sullivan at (702) 338–4766 or
Kimberly.Sullivan@boem.gov.
Cooperating Agencies: The following
nine Federal agencies and State
governmental entities participated as
cooperating agencies in the preparation
of the DEIS: Bureau of Safety and
Environmental Enforcement, U.S.
Environmental Protection Agency,
National Marine Fisheries Service, U.S.
Army Corps of Engineers, U.S. Coast
Guard, U.S. Fish and Wildlife Service,
New Jersey Department of
Environmental Protection, New Jersey
Board of Public Utilities, and New York
State Department of State. The National
Park Service and the Advisory Council
on Historic Preservation were
participating agencies.
Information on Submitting
Comments: BOEM does not encourage
the submittal of anonymous comments.
Please include your name and address
as part of your comment. BOEM makes
your comment, including your name
and address, available for public review
online and during regular business
hours. You may request that BOEM
withhold your name, address, or any
other personally identifiable
information (PII) included in your
VerDate Sep<11>2014
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comment from the public record;
however, BOEM cannot guarantee that it
will be able to do so. If you wish your
name, address, or other PII to be
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prominently in a cover letter and
explain the harm that you fear from its
disclosure such as unwarranted privacy
invasion, embarrassment, or injury.
Even if BOEM withholds your
information in the context of this notice,
your comment is subject to the Freedom
of Information Act (FOIA) and any
relevant court orders. If your comment
is requested under FOIA or a relevant
court order, your information will only
be withheld if a determination is made
that one of the FOIA’s exemptions to
disclosure applies or if the relevant
court order is challenged. Such a
determination will be made in
accordance with the Department of the
Interior’s FOIA regulations and
applicable law.
Please label privileged or confidential
information as ‘‘Contains Confidential
Information,’’ and consider submitting
such information as a separate
attachment. Information that is not
labeled as privileged or confidential
may be regarded by BOEM as suitable
for public release. Consistent with
section 304 of the NHPA (54 U.S.C.
307103(a)) and after consultation with
the Secretary, BOEM is required to
withhold the location, character, or
ownership of historic resources if it
determines that disclosure may, among
other things, risk harm to the historic
resources or impede the use of a
traditional religious site by
practitioners. Tribal entities should
designate information that falls under
section 304 of NHPA as confidential.
All submissions from organizations or
businesses and from individuals
identifying themselves as
representatives or officials of
organizations or businesses will be
made available for public inspection in
their entirety.
Authority: 42 U.S.C. 4231 et seq.
(NEPA, as amended) and 40 CFR 1506.6.
Karen J. Baker,
Chief, Office of Renewable Energy Programs,
Bureau of Ocean Energy Management.
[FR Doc. 2023–10691 Filed 5–18–23; 8:45 am]
BILLING CODE 4340–98–P
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32243
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
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
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 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 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
SUMMARY:
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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
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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
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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
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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
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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
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32245
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.
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Issued: May 15, 2023.
Lisa Barton,
Secretary to the Commission.
INTERNATIONAL TRADE
COMMISSION
[FR Doc. 2023–10701 Filed 5–18–23; 8:45 am]
[USITC SE–23–024]
Sunshine Act Meetings
BILLING CODE 7020–02–P
United
States International Trade Commission.
TIME AND DATE: May 25, 2023 at 11:00
a.m.
PLACE: Room 101, 500 E Street SW,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. Nos. 701–
TA–571–572 and 731–TA–147–1348
(Review)(Biodiesel from Argentina and
Indonesia). The Commission currently
is scheduled to complete and file its
determinations and views of the
Commission on June 2, 2023.
5. Outstanding action jackets: none.
CONTACT PERSON FOR MORE INFORMATION:
Sharon Bellamy, Acting Supervisory
Hearings and Information Officer, 202–
205–2000.
The Commission is holding the
meeting under the Government in the
Sunshine Act, 5 U.S.C. 552(b). In
accordance with Commission policy,
subject matter listed above, not disposed
of at the scheduled meeting, may be
carried over to the agenda of the
following meeting.
AGENCY HOLDING THE MEETING:
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 731–TA–696 (Fifth
Review)]
Pure Magnesium From China
Determination
On the basis of the record 1 developed
in the subject five-year review, the
United States International Trade
Commission (‘‘Commission’’)
determines, pursuant to the Tariff Act of
1930 (‘‘the Act’’), that revocation of the
antidumping duty order on pure
magnesium from China would be likely
to lead to continuation or recurrence of
material injury to an industry in the
United States within a reasonably
foreseeable time.2
Background
The Commission instituted this
review on March 1, 2022 (87 FR 11472)
and determined on June 6, 2022 that it
would conduct a full review (87 FR
35997, June 14, 2022). Notice of the
scheduling of the Commission’s review
and of a public hearing to be held in
connection therewith was given by
posting copies of the notice in the Office
of the Secretary, U.S. International
Trade Commission, Washington, DC,
and by publishing the notice in the
Federal Register on October 27, 2022
(87 FR 65822, November 1, 2022). The
Commission conducted its hearing on
March 14, 2023. All persons who
requested the opportunity were
permitted to participate.
The Commission made this
determination pursuant to section
751(c) of the Act (19 U.S.C. 1675(c)). It
completed and filed its determination in
this review on May 15, 2023. The views
of the Commission are contained in
USITC Publication 5420 (May 2023),
entitled Pure Magnesium from China:
Investigation No. 731–TA–696 (Fifth
Review).
1 The record is defined in § 207.2(f) of the
Commission’s Rules of Practice and Procedure (19
CFR 207.2(f)).
2 Commissioner Randolph J. Stayin did not
participate.
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DEPARTMENT OF JUSTICE
[OMB Number 1121–0094]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Annual
Survey of Jails (ASJ)
The Department of Justice
(DOJ), Office of Justice Programs,
Bureau of Justice Statistics, will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
SUMMARY:
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BILLING CODE 7020–02–P
Bureau of Justice Statistics,
Department of Justice.
ACTION: 30-Day notice.
[FR Doc. 2023–10673 Filed 5–18–23; 8:45 am]
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[FR Doc. 2023–10874 Filed 5–17–23; 4:15 pm]
AGENCY:
By order of the Commission.
Issued: May 15, 2023.
Lisa Barton,
Secretary to the Commission.
PO 00000
By order of the Commission.
Issued: May 17, 2023.
Sharon Bellamy,
Acting Supervisory Hearings and Information
Officer.
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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 [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)
[[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, 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
