[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]
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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.
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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
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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