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]


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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.

-----------------------------------------------------------------------

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


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