[Federal Register Volume 90, Number 109 (Monday, June 9, 2025)]
[Notices]
[Pages 24292-24294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10394]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1356]
Certain Dermatological Treatment Devices and Components Thereof;
Notice of a Commission Determination Finding a Violation of Section 337
as to Four Asserted Patents; Issuance of a Limited Exclusion Order and
Cease and Desist Orders; Remand of The Investigation as to One Asserted
Patent; Extension of the Target Date
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that the U.S. International Trade
Commission has found a violation of section 337 and has determined to
issue: a limited exclusion order prohibiting the unlicensed importation
of certain dermatological treatment devices and components thereof that
infringe one or more of claims 1, 9, and 22 of U.S. Patent No.
9,480,836 (``the '836 patent''); claims 11 and 16 of U.S. Patent No.
9,320,536 (``the '536 patent''); claim 14 of U.S. Patent No. 9,775,774
(``the '774 patent''); and claims 5, 13, and 18 of U.S. Patent No.
10,869,812 (``the '812 patent''); cease and desist orders against
Respondents EndyMed Medical Ltd. of Caesarea, Israel; EndyMed Medical,
Ltd. of New York, New York; and EndyMed Medical, Inc. of Freehold, New
Jersey (collectively, ``EndyMed''); and set a bond in the amount of
eighty-five percent (85%) of the entered value of the EndyMed Pure, and
seventy percent (70%) of the entered value of the EndyMed Pro
infringing products imported during the period of Presidential review.
The investigation is terminated with respect to these four patents. The
Commission has also determined to reverse the presiding administrative
law judge's (``ALJ'') finding that asserted claims 4, 6, and 7 of U.S.
Patent No. 11,406,444 (``the '444 patent'') are indefinite, remand the
investigation to the ALJ with respect to that patent consistent with
the concurrently issued Commission opinion and remand order, and extend
the target date for completion of the investigation.
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, California (``Serendia''). 88 FR 20551-52 (Apr. 6, 2023). The
complaint, as supplemented, alleges 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 the '836 patent; claims 1-5, 7-10,
and 15 of U.S. Patent No. 10,058,379; claims 1-10 of the '444 patent;
claims 1, 2, 4, 5, 8, 9, 11-13, 16, and 17 of the '536 patent; claims 1
and 6-15 of the '774 patent; and claims 1, 5-7, 9, 10, and 12-19 of the
'812 patent. Id. at 20551. The complaint further alleges 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
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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. 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; claims 5, 13, and 18 of the '812 patent; and claims 4, 6, and 7
of the '444 patent. 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. 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);
Order No. 64 (Dec.18, 2024), unreviewed by Comm'n Notice (Jan. 17,
2025).
The ALJ held a Markman hearing 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 ALJ found the pending claims
of the '444 patent, claims 4, 6, and 7, indefinite in the Markman Order
and did not consider those claims any further in the Investigation.
Markman (Order No. 35) at 62.
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 19, 2024, the ALJ issued the final initial
determination (``ID'') in this investigation finding a violation of
section 337 as to 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 by respondents EndyMed, Jeisys, and Cynosure.
The ID found that by appearing and participating in the investigation,
the parties 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 further 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 remaining five patents.
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
recommended that ``the Commission enter a bond in the amount of 85% of
the price of value EndyMed Pure product and 70% of the value of the
EndyMed Pro product during the PRP [period of Presidential review].''
Id. at 314.
Regarding Jeisys and Cynosure, the ID noted that they have been
terminated from the investigation by the ALJ, but that given the timing
of the termination, the analyses pertaining to them contained in the ID
would not be deleted. ID at ii n.1. The ID stated that once the
Commission addresses the ID terminating them, ``Jeisys and Cynosure are
no longer parties in this Investigation,'' and their ``accused products
will no longer be at issue in this Investigation and will not be
subject to any determinations set forth in the ID.'' Id.; Order No. 64
(Dec. 18, 2024) (terminating Jeisys and Cynosure from the
investigation), unreviewed by Comm'n Notice (Jan. 17, 2025).
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.
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.
On February 28, 2025, the Commission determined to review the final
ID in part. 90 FR 11433-36 (Mar. 6, 2023). Specifically, the Commission
determined to review the final 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. The
Commission requested briefing on certain issues under review and on
remedy, the public interest, and bonding. Id.
In its notice of review, the Commission vacated the findings in the
ID pertaining to Jeisys and Cynosure due to their termination from the
investigation. 90 FR 11435 (Mar. 6, 2023).
On March 14, 2025, the parties filed initial submissions in
response to the Commission's request for briefing. On March 21, 2025,
the parties filed reply submissions.
Upon review of the parties' submissions, the ID, the RD, evidence
of
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record, and the public interest, the Commission has determined that
EndyMed violated section 337 by reason of importation and sale of
articles that infringe asserted 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. Regarding the issues under
review, the Commission has determined to (1) provide the modification
in the accompanying Commission opinion for the ID's findings on
jurisdiction and standing, (2) affirm the ID's findings on the economic
prong of domestic industry for the reasons provided in the ID as
supplemented in the opinion, (3) take no position on the ID's
contributory infringement finding, (4) affirm the ID's findings on
secondary considerations for the reasons provided in the ID, and (5)
reverse and remand the ID's indefiniteness finding of the asserted
claims of the '444 patent.
For the '444 patent, the Commission has determined to remand to the
ALJ for further proceedings consistent with the Commission's opinion
and remand order. The target date is extended to July 8, 2025. For
remedy, the Commission has determined to issue a limited exclusion
order prohibiting further importation of infringing products and cease
and desist orders against EndyMed. The Commission has also determined
that the public interest factors enumerated in paragraphs 337(d)(1) and
(f)(1) (19 U.S.C. 1337(d)(1), (f)(1)) do not preclude the issuance of
these remedial orders. The Commission has determined to set a bond in
the amount of eighty-five percent (85%) of the entered value of the
EndyMed Pure, and seventy percent (70%) of the entered value of the
EndyMed Pro, for infringing products imported during the period of
Presidential review pursuant to 19 U.S.C. 1337(j). The Commission's
orders were delivered to the President and to the United States Trade
Representative on the day of their issuance.
The Commission vote for this determination took place on June 3,
2025. The investigation is hereby terminated with respect to the '836,
'536, '774, and '812 patents. The '444 patent is remanded to the
ALJ.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: June 3, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-10394 Filed 6-6-25; 8:45 am]
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