Certain Dermatological Treatment Devices and Components Thereof; Notice of 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, 11433-11436 [2025-03592]
Download as PDF
11433
Federal Register / Vol. 90, No. 43 / Thursday, March 6, 2025 / Notices
ADDRESSES:
Interested persons are
invited to submit comments regarding
this proposal. Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
Copies of available documents
submitted to OMB may be obtained
from Ms. Guido.
SUPPLEMENTARY INFORMATION: This
notice informs the public that HUD is
seeking approval from OMB for the
information collection described in
Section A. The Federal Register notice
that solicited public comment on the
information collection for a period of 60
days was published on September 24,
2024 at 89 FR 77890.
FOR FURTHER INFORMATION CONTACT:
A. Overview of Information Collection
Anna Guido, Clearance Officer,
Paperwork Reduction Act Division,
PRAD, Department of Housing and
Urban Development, 451 7th Street SW,
Washington, DC 20410; email at
Anna.P.Guido@hud.gov, telephone (202)
402–5535. This is not a toll-free number.
HUD welcomes and is prepared to
receive calls from individuals who are
deaf or hard of hearing, as well as
individuals with speech or
communication disabilities. To learn
more about how to make an accessible
telephone call, please visit https://
www.fcc.gov/consumers/guides/
telecommunications-relay-service-trs.
Title of Information Collection: CDBG
Urban County Qualification/New York
Towns Qualification/Requalification
Process, Notice.
OMB Approval Number: 2506–0170.
Type of Request: Reinstatement with
change.
Form Number: N/A.
Description of the need for the
information and proposed use: The
Housing and Community Development
Act of 1974, as amended (the Act), at
sections 102(a)(6) and 102(e) requires
that any county seeking qualification as
an urban county notify each unit of
general local government within the
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Information collection
Frequency
of response
Responses
per annum
county that such unit may elect to have
its population excluded from that of the
urban county. Section 102(d) of the Act
specifies that the period of qualification
will be three years. Based on these
statutory provisions, counties seeking
qualification or requalification as urban
counties under the CDBG program must
provide information to HUD every three
years identifying the units of general
local governments (UGLGs) within the
county participating as a part of the
county for purposes of receiving CDBG
funds. The population of UGLGs for
each eligible urban county is used in
HUD’s allocation of CDBG funds for all
entitlement and State CDBG grantees.
New York Towns may qualify as
metropolitan cities if they are able to
secure the participation of all of the
villages located within their boundaries.
Any New York Town that is located in
an urban county may choose to leave
that urban county when that county is
requalifying. A New York Town will be
required to notify the urban county in
advance of its decision to decline
participation in the urban county’s
CDBG program and complete the
metropolitan city qualification process.
Burden
hour per
response
Annual
burden
hours
Hourly
cost per
response
Annual cost
2506–0170 .............................................
2506–0170 .............................................
2
65
1
1
2
65
120
67
240
4,355
$48.59
48.59
$11,661.20
211,609.45
Total ................................................
......................
......................
67
..................
4,595.00
..................
223,271.05
B. Solicitation of Public Comment
C. Authority
This notice is soliciting comments
from members of the public and affected
parties concerning the collection of
information described in Section A on
the following:
(1) Whether the proposed collection
of information is necessary for the
proper performance of the functions of
the agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information;
(3) Ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) Ways to minimize the burden of
the collection of information on those
who are to respond; including through
the use of appropriate automated
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
HUD encourages interested parties to
submit comment in response to these
questions.
Section 3507 of the Paperwork
Reduction Act of 1995, 44 U.S.C.
Chapter 35.
VerDate Sep<11>2014
16:42 Mar 05, 2025
Jkt 265001
Anna Guido,
Department Clearance Officer, Office of
Policy Development and Research, Chief Data
Officer.
[FR Doc. 2025–03595 Filed 3–5–25; 8:45 am]
BILLING CODE 4210–67–P
PO 00000
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–1356]
Certain Dermatological Treatment
Devices and Components Thereof;
Notice of 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
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
Notice is hereby given that
U.S. International Trade Commission
(‘‘Commission’’) has determined to
review a final initial determination
(‘‘ID’’) of the presiding administrative
law judge (‘‘ALJ’’), finding a violation of
section 337 as to four asserted patents
and no violation as to one asserted
patent. The Commission requests
written submissions from the parties on
SUMMARY:
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\06MRN1.SGM
06MRN1
lotter on DSK11XQN23PROD with NOTICES1
11434
Federal Register / Vol. 90, No. 43 / Thursday, March 6, 2025 / Notices
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:
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
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 April 6, 2023, based on a complaint
filed by Serendia, LLC of Lake Forest,
CA (‘‘Serendia’’). 88 FR 20551–52 (Apr.
6, 2023). The complaint, as
supplemented, alleged violations of
section 337 of the Tariff Act of 1930, as
amended, 19 U.S.C. 1337, in the
importation into the United States, the
sale for importation, or the sale within
the United States after importation of
certain dermatological treatment devices
and components thereof by reason of
infringement of claims 1, 2, 5, 6, 9, 14,
16, 17, 19, and 22 of U.S. Patent No.
9,480,836 (‘‘the ’836 patent’’); claims 1–
5, 7–10, and 15 of U.S. Patent No.
10,058,379; claims 1–10 of U.S. Patent
No. 11,406,444 (‘‘the ’444 patent’’);
claims 1, 2, 4, 5, 8, 9, 11–13, 16, and 17
of U.S. Patent No. 9,320,536 (‘‘the ’536
patent’’); claims 1 and 6–15 of U.S.
Patent No. 9,775,774 (‘‘the ’774 patent’);
and claims 1, 5–7, 9, 10, and 12–19 of
U.S. Patent No. 10,869,812 (‘‘the ’812
patent’’). Id. at 20551. The complaint
further alleged that a domestic industry
exists. Id. The Commission’s notice of
investigation named as respondents
Sung Hwan E&B Co., LTD. d/b/a SHEnB
Co. LTD of Seoul, Republic of Korea;
Aesthetics Biomedical, Inc. of Phoenix,
Arizona; Cartessa Aesthetics, LLC of
Melville, New York; Lutronic
Corporation of Goyang-si, Republic of
Korea; Lutronic Aesthetics, Inc., also
known as Lutronic, Inc. of Billerica,
Massachusetts; Lutronic, LLC of
Billerica, Massachusetts; Ilooda, Co.,
Ltd. of Anyang-si, Republic of Korea;
VerDate Sep<11>2014
16:42 Mar 05, 2025
Jkt 265001
Cutera, Inc. of Brisbane, California;
Rohrer Aesthetics, LLC of Homewood,
Alabama; Rohrer Aesthetics, Inc. of
Homewood, Alabama; Jeisys Medical
Inc. of Seoul, Republic of Korea
(‘‘Jeisys’’); Cynosure, LLC of Westford,
Massachusetts (‘‘Cynosure’’); and
EndyMed Medical Ltd. of Caesarea,
Israel; EndyMed Medical, Ltd. of New
York, New York; and EndyMed Medical,
Inc. of Freehold, New Jersey (together,
‘‘EndyMed’’). Id. at 20552. The Office of
Unfair Import Investigations (‘‘OUII’’) is
also participating in the investigation.
Id.
The Commission subsequently
terminated the investigation as to all
asserted patent claims except for claims
1, 9, and 22 of the ’836 patent; claims
11 and 16 of the ’536 patent; claim 14
of the ’774 patent; and claims 5, 13, and
18 of the ’812 patent, which remain
pending in this investigation. See Order
No. 16 (June 29, 2023), unreviewed by
Comm’n Notice (July 20, 2023); Order
No. 27 (Sept. 25, 2023), unreviewed by
Comm’n Notice (Oct. 16, 2023); Order
No. 43 (Nov. 8, 2023), unreviewed by
Comm’n Notice (Dec. 12, 2023).
The Commission also subsequently
terminated the investigation as to all
respondents except for EndyMed, Jeisys,
and Cynosure. See Order No. 26 (Sept.
18, 2023), unreviewed by Comm’n
Notice (Oct. 16, 2023); Order No. 38
(Oct. 27, 2023), unreviewed by Comm’n
Notice (Nov. 20, 2023); Order No. 45
(Nov. 15, 2023), unreviewed by Comm’n
Notice (Dec. 15, 2023); Order No. 47
(Nov. 20, 2023), unreviewed by Comm’n
Notice (Dec. 15, 2023); Order No. 53
(Apr. 11, 2024), unreviewed by Comm’n
Notice (May 8, 2024); Order No. 51 (Dec.
13, 2023), unreviewed by Comm’n
Notice (Jan. 10, 2024).
The ALJ held a Markman Order on
July 13, 2023, and issued a Markman
Order on October 25, 2023, construing
certain disputed claim terms. Order No.
35 (Oct. 25, 2023). The Markman Order
found the asserted claims of the ’444
patent indefinite and terminated the
investigation as the ’444 patent.
The ALJ held an evidentiary hearing
on November 1–2, 6–7, 2023 and
December 11–12, 2023, and received
post-hearing briefs thereafter.
Remaining in the investigation at that
time were respondents EndyMed, Jeisys,
and Cynosure and claims 1, 9, and 22
of the ’836 patent; claims 11 and 16 of
the ’536 patent; claim 14 of the ’774
patent; and claims 5, 13, and 18 of the
’812 patent.
On December 18, 2024, the ALJ issued
an ID granting a motion to terminate the
investigation as to respondents Jeisys
and Cynosure based upon settlement.
Order No. 64 (Dec. 18, 2024),
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
unreviewed by Comm’n Notice (Jan. 17,
2025).
On December 19, 2024, the ALJ issued
the final ID finding a violation of section
337 as to the asserted patent claims
remaining in the investigation by
respondents EndyMed, Jeisys, and
Cynosure. Specifically, the ID found
that by appearing and participating in
the investigation, the parties have
consented to personal jurisdiction at the
Commission. ID at 13. The ID found the
importation requirement under 19
U.S.C. 1337(a)(1)(B) satisfied and that
the Commission has in rem jurisdiction,
noting that ‘‘[t]he Private Parties entered
stipulations with respect to the
importation of Accused Products
wherein each Respondent stipulated
that they have imported to the United
States, sold for importation into the
United States, and/or sold within the
United States after importation at least
one Accused Product.’’ Id. The ID found
that Serendia has the exclusive rights
and ownership in the Asserted Patents
and thus has standing to assert the
patents in this investigation. Id. at 23.
The ID found that Serendia successfully
proved that the accused products
directly infringe the Asserted Claims. ID
at 70–88, 173–184, 216–225. The ID
further found that EndyMed also
indirectly infringes the asserted claims
of the ’836 and ’536 patents via
inducement and contributory
infringement. ID at 97–104, 185–188.
The ID found that EndyMed failed to
show that the Asserted Claims are
invalid for obviousness (ID at 120–145,
209–216, 230–232, 257–267). The ID
found that EndyMed also failed to show
that the asserted claims of the’536
patent are invalid for anticipation (ID at
196–209) and also failed to prove that
the asserted claims of the’836 patent are
invalid for lack of enablement (ID at
146–161), lack of written description
support (ID at 161–167), or recite
unpatentable subject matter under
section 101 (ID at 167–173). The ID
found the existence of a domestic
industry that practices the Asserted
Patents as required by 19 U.S.C.
1337(a)(2). ID at 104–110, 189–196,
226–230, 247–256, 267–300.
Accordingly, the ID found a violation of
section 337 as to four of the five patents
remaining in the investigation.
The ID included the ALJ’s
recommended determination on remedy
and bonding (‘‘RD’’). The RD
recommended, should the Commission
find a violation, issuance of a limited
exclusion order and cease and desist
orders against EndyMed. ID/RD at 302–
111. Regarding the amount of bond to be
imposed during the period of
Presidential review, the ID
E:\FR\FM\06MRN1.SGM
06MRN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 90, No. 43 / Thursday, March 6, 2025 / Notices
‘‘recommended that the Commission
enter a bond of 10% for the Accused
Potenza Products’’ but that ‘‘if the
Commission finds that the 10% royalty
rate in the Patent License Agreement is
inapplicable to the Accused Potenza
Products, then it is recommended that a
5–6% bond rate be entered on value
because Respondents conceded that a 5–
6% bond is ‘economically reasonable.’ ’’
Id. at 318.
On January 2, 2025, Jeisys and
Cynosure filed a petition for review,
asking the Commission to set aside the
findings in the ID pertaining to them
because of their termination from the
investigation. The Commission has
determined to review and vacate the
findings in the ID pertaining to Jeisys
and Cynosure due to their termination
from the investigation. See ID at ii n.1.
On January 10, 2025, Serendia and
EndyMed filed respective petitions for
review of the ID. On January 21, 2025,
the parties, including OUII, 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 ID’s findings on jurisdiction,
standing, economic prong of domestic
industry for all five patents,
contributory infringement for the
asserted claims of the ’536, ’774, ’812,
and ’836 patents, secondary
considerations for the ’536 and ’836
patents, and indefiniteness of the
asserted claims of the ’444 patent.
In connection with its review, there is
interest in 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) Does section 337 allow
investments of an implied licensee to
count towards the existence of a
domestic industry?
(2) Under the terms of the agreement
between Serendia and ViOL, could
ViOL grant an implied sublicense to
Benev?
(3) Under the doctrine of patent
exhaustion, did Serendia extinguish its
rights to the domestic industry products
upon ViOL’s sale to Benev? Does it
matter whether Benev is an implied
licensee?
(4) Provide a breakout of the
investments for Benev Personnel,
Medical Professionals, and Medical and
Scientific Advisor presented in CDX–
0003C.48 among the six categories of
investments delineated in the ID at 279.
Please also provide a breakout of the
VerDate Sep<11>2014
16:42 Mar 05, 2025
Jkt 265001
investments on an annual basis and
prior to and after the date of the
agreement in CX–0765C.
(5) To the extent not already briefed,
to what extent are any of the six
categories of investments delineated in
the ID at 279 of the sort that a mere
importer would engage in, including by
addressing if they are activities that
must by their nature be performed in the
United States as a legal or a practical
matter, such that they might not be
distinguishable from the activities of a
mere importer?
(6) Address if there is any distinction
or legal requirement under the statute or
legislative history of Section 337 or by
Commission or Federal Circuit
precedent that certain activities are only
cognizable if (1) the activities must be
performed in the United States or (2) if
the activities are chosen to be performed
in the United States?
(7) What costs for contractors (both
types of services and amounts) are not
included in the data provided for
ViOL’s manufacturing costs (see, e.g.,
RX–2566C at 119:1–11, CPX–0156C)?
Please provide a breakout prior to and
after the date of the agreement in CX–
0765C.
(8) Regarding the ’444 patent, if the
Commission finds that the claims are
not indefinite, what benefit is there in
remanding to the ALJ? Would an
exclusion order naming the’444 patent
cover products that the asserted claims
of the ’836 patent would not cover?
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
11435
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.
If any respondents are requesting that
remedial orders contain an exemption
related to service and/or repair, parties
are invited to address the following
issues, as appropriate.
(1) What is the rationale for providing
an exemption, either under the
Commission’s broad remedial discretion
or under the public interest factors?
Please provide available factual
evidence in support, including any not
currently on the record.
(2) What are the warranty terms, if
any, for the merchandise in question?
(3) Should the exemption apply only
to merchandise under warranty, or to all
needed service and repair?
(4) Should the exemption cover only
parts for service/repair, or should it also
allow complete replacement of
merchandise?
(5) What should the temporal cutoff
be for the exemption, e.g., should the
operative date be the issuance of the
Commission’s final determination or the
end of the Presidential review period,
and should it apply to merchandise sold
prior to such date or imported prior to
such date?
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
E:\FR\FM\06MRN1.SGM
06MRN1
lotter on DSK11XQN23PROD with NOTICES1
11436
Federal Register / Vol. 90, No. 43 / Thursday, March 6, 2025 / Notices
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
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 March 14,
2025. Reply submissions must be filed
no later than the close of business on
March 21, 2025. Opening submissions
are limited to 60 pages. Reply
submissions are limited to 30 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 pursuant to 19 CFR
210.4(f). Submissions should refer to the
investigation number (Inv. No. 337–TA–
1356) 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
VerDate Sep<11>2014
16:42 Mar 05, 2025
Jkt 265001
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 February
28, 2025.
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: February 28, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025–03592 Filed 3–5–25; 8:45 am]
BILLING CODE 7020–02–P
INTERNATIONAL TRADE
COMMISSION
[Investigation Nos. 701–TA–754 and 731–
TA–1732 (Preliminary)]
Temporary Steel Fencing From China
Determinations
On the basis of the record 1 developed
in the subject investigations, the United
States International Trade Commission
(‘‘Commission’’) determines, pursuant
to the Tariff Act of 1930 (‘‘the Act’’),
that there is a reasonable indication that
an industry in the United States is
materially injured by reason of imports
of temporary steel fencing from China,
provided for in subheading 7308.90.95
of the Harmonized Tariff Schedule of
the United States, that are alleged to be
sold in the United States at less than fair
value (‘‘LTFV’’) and alleged to be
subsidized by the government of China.2
1 The record is defined in § 207.2(f) of the
Commission’s Rules of Practice and Procedure (19
CFR 207.2(f)).
2 90 FR 9311 and 90 FR 9315 (February 11, 2025).
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Commencement of Final Phase
Investigations
Pursuant to section 207.18 of the
Commission’s rules, the Commission
also gives notice of the commencement
of the final phase of its investigations.
The Commission will issue a final phase
notice of scheduling, which will be
published in the Federal Register as
provided in § 207.21 of the
Commission’s rules, upon notice from
the U.S. Department of Commerce
(‘‘Commerce’’) of affirmative
preliminary determinations in the
investigations under §§ 703(b) or 733(b)
of the Act, or, if the preliminary
determinations are negative, upon
notice of affirmative final
determinations in those investigations
under §§ 705(a) or 735(a) of the Act.
Parties that filed entries of appearance
in the preliminary phase of the
investigations need not enter a separate
appearance for the final phase of the
investigations. Any other party may file
an entry of appearance for the final
phase of the investigations after
publication of the final phase notice of
scheduling. Industrial users, and, if the
merchandise under investigation is sold
at the retail level, representative
consumer organizations have the right
to appear as parties in Commission
antidumping and countervailing duty
investigations. The Secretary will
prepare a public service list containing
the names and addresses of all persons,
or their representatives, who are parties
to the investigations. As provided in
section 207.20 of the Commission’s
rules, the Director of the Office of
Investigations will circulate draft
questionnaires for the final phase of the
investigations to parties to the
investigations, placing copies on the
Commission’s Electronic Document
Information System (EDIS, https://
edis.usitc.gov), for comment.
Background
On January 15, 2025, ZND US Inc.,
Statesville, North Carolina, filed
petitions with the Commission and
Commerce, alleging that an industry in
the United States is materially injured
or threatened with material injury by
reason of subsidized and LTFV imports
of temporary steel fencing from China.
Accordingly, effective January 15, 2025,
the Commission instituted
countervailing duty investigation No.
701–TA–754 and antidumping duty
investigation No. 731–TA–1732
(Preliminary).
Notice of the institution of the
Commission’s investigations and of a
public conference to be held in
connection therewith was given by
E:\FR\FM\06MRN1.SGM
06MRN1
Agencies
[Federal Register Volume 90, Number 43 (Thursday, March 6, 2025)]
[Notices]
[Pages 11433-11436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-03592]
=======================================================================
-----------------------------------------------------------------------
INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1356]
Certain Dermatological Treatment Devices and Components Thereof;
Notice of 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
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that U.S. International Trade
Commission (``Commission'') has determined to review a final initial
determination (``ID'') of the presiding administrative law judge
(``ALJ''), finding a violation of section 337 as to four asserted
patents and no violation as to one asserted patent. The Commission
requests written submissions from the parties on
[[Page 11434]]
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: 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: The Commission instituted this investigation
on April 6, 2023, based on a complaint filed by Serendia, LLC of Lake
Forest, CA (``Serendia''). 88 FR 20551-52 (Apr. 6, 2023). The
complaint, as supplemented, alleged violations of section 337 of the
Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into
the United States, the sale for importation, or the sale within the
United States after importation of certain dermatological treatment
devices and components thereof by reason of infringement of claims 1,
2, 5, 6, 9, 14, 16, 17, 19, and 22 of U.S. Patent No. 9,480,836 (``the
'836 patent''); claims 1-5, 7-10, and 15 of U.S. Patent No. 10,058,379;
claims 1-10 of U.S. Patent No. 11,406,444 (``the '444 patent''); claims
1, 2, 4, 5, 8, 9, 11-13, 16, and 17 of U.S. Patent No. 9,320,536 (``the
'536 patent''); claims 1 and 6-15 of U.S. Patent No. 9,775,774 (``the
'774 patent'); and claims 1, 5-7, 9, 10, and 12-19 of U.S. Patent No.
10,869,812 (``the '812 patent''). Id. at 20551. The complaint further
alleged that a domestic industry exists. Id. The Commission's notice of
investigation named as respondents Sung Hwan E&B Co., LTD. d/b/a SHEnB
Co. LTD of Seoul, Republic of Korea; Aesthetics Biomedical, Inc. of
Phoenix, Arizona; Cartessa Aesthetics, LLC of Melville, New York;
Lutronic Corporation of Goyang-si, Republic of Korea; Lutronic
Aesthetics, Inc., also known as Lutronic, Inc. of Billerica,
Massachusetts; Lutronic, LLC of Billerica, Massachusetts; Ilooda, Co.,
Ltd. of Anyang-si, Republic of Korea; Cutera, Inc. of Brisbane,
California; Rohrer Aesthetics, LLC of Homewood, Alabama; Rohrer
Aesthetics, Inc. of Homewood, Alabama; Jeisys Medical Inc. of Seoul,
Republic of Korea (``Jeisys''); Cynosure, LLC of Westford,
Massachusetts (``Cynosure''); and EndyMed Medical Ltd. of Caesarea,
Israel; EndyMed Medical, Ltd. of New York, New York; and EndyMed
Medical, Inc. of Freehold, New Jersey (together, ``EndyMed''). Id. at
20552. The Office of Unfair Import Investigations (``OUII'') is also
participating in the investigation. Id.
The Commission subsequently terminated the investigation as to all
asserted patent claims except for claims 1, 9, and 22 of the '836
patent; claims 11 and 16 of the '536 patent; claim 14 of the '774
patent; and claims 5, 13, and 18 of the '812 patent, which remain
pending in this investigation. See Order No. 16 (June 29, 2023),
unreviewed by Comm'n Notice (July 20, 2023); Order No. 27 (Sept. 25,
2023), unreviewed by Comm'n Notice (Oct. 16, 2023); Order No. 43 (Nov.
8, 2023), unreviewed by Comm'n Notice (Dec. 12, 2023).
The Commission also subsequently terminated the investigation as to
all respondents except for EndyMed, Jeisys, and Cynosure. See Order No.
26 (Sept. 18, 2023), unreviewed by Comm'n Notice (Oct. 16, 2023); Order
No. 38 (Oct. 27, 2023), unreviewed by Comm'n Notice (Nov. 20, 2023);
Order No. 45 (Nov. 15, 2023), unreviewed by Comm'n Notice (Dec. 15,
2023); Order No. 47 (Nov. 20, 2023), unreviewed by Comm'n Notice (Dec.
15, 2023); Order No. 53 (Apr. 11, 2024), unreviewed by Comm'n Notice
(May 8, 2024); Order No. 51 (Dec. 13, 2023), unreviewed by Comm'n
Notice (Jan. 10, 2024).
The ALJ held a Markman Order on July 13, 2023, and issued a Markman
Order on October 25, 2023, construing certain disputed claim terms.
Order No. 35 (Oct. 25, 2023). The Markman Order found the asserted
claims of the '444 patent indefinite and terminated the investigation
as the '444 patent.
The ALJ held an evidentiary hearing on November 1-2, 6-7, 2023 and
December 11-12, 2023, and received post-hearing briefs thereafter.
Remaining in the investigation at that time were respondents EndyMed,
Jeisys, and Cynosure and claims 1, 9, and 22 of the '836 patent; claims
11 and 16 of the '536 patent; claim 14 of the '774 patent; and claims
5, 13, and 18 of the '812 patent.
On December 18, 2024, the ALJ issued an ID granting a motion to
terminate the investigation as to respondents Jeisys and Cynosure based
upon settlement. Order No. 64 (Dec. 18, 2024), unreviewed by Comm'n
Notice (Jan. 17, 2025).
On December 19, 2024, the ALJ issued the final ID finding a
violation of section 337 as to the asserted patent claims remaining in
the investigation by respondents EndyMed, Jeisys, and Cynosure.
Specifically, the ID found that by appearing and participating in the
investigation, the parties have consented to personal jurisdiction at
the Commission. ID at 13. The ID found the importation requirement
under 19 U.S.C. 1337(a)(1)(B) satisfied and that the Commission has in
rem jurisdiction, noting that ``[t]he Private Parties entered
stipulations with respect to the importation of Accused Products
wherein each Respondent stipulated that they have imported to the
United States, sold for importation into the United States, and/or sold
within the United States after importation at least one Accused
Product.'' Id. The ID found that Serendia has the exclusive rights and
ownership in the Asserted Patents and thus has standing to assert the
patents in this investigation. Id. at 23. The ID found that Serendia
successfully proved that the accused products directly infringe the
Asserted Claims. ID at 70-88, 173-184, 216-225. The ID further found
that EndyMed also indirectly infringes the asserted claims of the '836
and '536 patents via inducement and contributory infringement. ID at
97-104, 185-188. The ID found that EndyMed failed to show that the
Asserted Claims are invalid for obviousness (ID at 120-145, 209-216,
230-232, 257-267). The ID found that EndyMed also failed to show that
the asserted claims of the'536 patent are invalid for anticipation (ID
at 196-209) and also failed to prove that the asserted claims of
the'836 patent are invalid for lack of enablement (ID at 146-161), lack
of written description support (ID at 161-167), or recite unpatentable
subject matter under section 101 (ID at 167-173). The ID found the
existence of a domestic industry that practices the Asserted Patents as
required by 19 U.S.C. 1337(a)(2). ID at 104-110, 189-196, 226-230, 247-
256, 267-300. Accordingly, the ID found a violation of section 337 as
to four of the five patents remaining in the investigation.
The ID included the ALJ's recommended determination on remedy and
bonding (``RD''). The RD recommended, should the Commission find a
violation, issuance of a limited exclusion order and cease and desist
orders against EndyMed. ID/RD at 302-111. Regarding the amount of bond
to be imposed during the period of Presidential review, the ID
[[Page 11435]]
``recommended that the Commission enter a bond of 10% for the Accused
Potenza Products'' but that ``if the Commission finds that the 10%
royalty rate in the Patent License Agreement is inapplicable to the
Accused Potenza Products, then it is recommended that a 5-6% bond rate
be entered on value because Respondents conceded that a 5-6% bond is
`economically reasonable.' '' Id. at 318.
On January 2, 2025, Jeisys and Cynosure filed a petition for
review, asking the Commission to set aside the findings in the ID
pertaining to them because of their termination from the investigation.
The Commission has determined to review and vacate the findings in the
ID pertaining to Jeisys and Cynosure due to their termination from the
investigation. See ID at ii n.1.
On January 10, 2025, Serendia and EndyMed filed respective
petitions for review of the ID. On January 21, 2025, the parties,
including OUII, 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 ID's findings on jurisdiction, standing, economic prong of
domestic industry for all five patents, contributory infringement for
the asserted claims of the '536, '774, '812, and '836 patents,
secondary considerations for the '536 and '836 patents, and
indefiniteness of the asserted claims of the '444 patent.
In connection with its review, there is interest in 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) Does section 337 allow investments of an implied licensee to
count towards the existence of a domestic industry?
(2) Under the terms of the agreement between Serendia and ViOL,
could ViOL grant an implied sublicense to Benev?
(3) Under the doctrine of patent exhaustion, did Serendia
extinguish its rights to the domestic industry products upon ViOL's
sale to Benev? Does it matter whether Benev is an implied licensee?
(4) Provide a breakout of the investments for Benev Personnel,
Medical Professionals, and Medical and Scientific Advisor presented in
CDX-0003C.48 among the six categories of investments delineated in the
ID at 279. Please also provide a breakout of the investments on an
annual basis and prior to and after the date of the agreement in CX-
0765C.
(5) To the extent not already briefed, to what extent are any of
the six categories of investments delineated in the ID at 279 of the
sort that a mere importer would engage in, including by addressing if
they are activities that must by their nature be performed in the
United States as a legal or a practical matter, such that they might
not be distinguishable from the activities of a mere importer?
(6) Address if there is any distinction or legal requirement under
the statute or legislative history of Section 337 or by Commission or
Federal Circuit precedent that certain activities are only cognizable
if (1) the activities must be performed in the United States or (2) if
the activities are chosen to be performed in the United States?
(7) What costs for contractors (both types of services and amounts)
are not included in the data provided for ViOL's manufacturing costs
(see, e.g., RX-2566C at 119:1-11, CPX-0156C)? Please provide a breakout
prior to and after the date of the agreement in CX-0765C.
(8) Regarding the '444 patent, if the Commission finds that the
claims are not indefinite, what benefit is there in remanding to the
ALJ? Would an exclusion order naming the'444 patent cover products that
the asserted claims of the '836 patent would not cover?
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.
If any respondents are requesting that remedial orders contain an
exemption related to service and/or repair, parties are invited to
address the following issues, as appropriate.
(1) What is the rationale for providing an exemption, either under
the Commission's broad remedial discretion or under the public interest
factors? Please provide available factual evidence in support,
including any not currently on the record.
(2) What are the warranty terms, if any, for the merchandise in
question?
(3) Should the exemption apply only to merchandise under warranty,
or to all needed service and repair?
(4) Should the exemption cover only parts for service/repair, or
should it also allow complete replacement of merchandise?
(5) What should the temporal cutoff be for the exemption, e.g.,
should the operative date be the issuance of the Commission's final
determination or the end of the Presidential review period, and should
it apply to merchandise sold prior to such date or imported prior to
such date?
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
[[Page 11436]]
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 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 March 14, 2025. Reply submissions must be filed no later than the
close of business on March 21, 2025. Opening submissions are limited to
60 pages. Reply submissions are limited to 30 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 pursuant to 19
CFR 210.4(f). Submissions should refer to the investigation number
(Inv. No. 337-TA-1356) 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 February
28, 2025.
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: February 28, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-03592 Filed 3-5-25; 8:45 am]
BILLING CODE 7020-02-P