Notice2025-23801
Certain Clear Aligners and Components Thereof; Institution of Investigation
Primary source
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Published
December 29, 2025
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 23, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of Align Technology, Inc. of Tempe, Arizona. A letter supplementing the complaint was filed on November 20, 2025. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain clear aligners and components thereof by reason of the infringement of certain claims of U.S. Patent No. 11,766,313 ("the '313 patent"); U.S. Patent No. 11,766,314 ("the '314 patent"); U.S. Patent No. 8,899,977 ("the '977 patent"); U.S. Patent No. 12,059,321 ("the '321 patent"); U.S. Patent No. 10,980,616 ("the '616 patent"); and U.S. Patent No. 11,490,996 ("the '996 patent"). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Full Text
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<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
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[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Page 60740]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23801]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1471]
Certain Clear Aligners and Components Thereof; Institution of
Investigation
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that a complaint was filed with the
U.S. International Trade Commission on September 23, 2025, under
section 337 of the Tariff Act of 1930, as amended, on behalf of Align
Technology, Inc. of Tempe, Arizona. A letter supplementing the
complaint was filed on November 20, 2025. The complaint, as
supplemented, alleges violations of section 337 based upon the
importation into the United States, the sale for importation, and the
sale within the United States after importation of certain clear
aligners and components thereof by reason of the infringement of
certain claims of U.S. Patent No. 11,766,313 (``the '313 patent'');
U.S. Patent No. 11,766,314 (``the '314 patent''); U.S. Patent No.
8,899,977 (``the '977 patent''); U.S. Patent No. 12,059,321 (``the '321
patent''); U.S. Patent No. 10,980,616 (``the '616 patent''); and U.S.
Patent No. 11,490,996 (``the '996 patent''). The complaint further
alleges that an industry in the United States exists as required by the
applicable Federal Statute.
The complainant requests that the Commission institute an
investigation and, after the investigation, issue a limited exclusion
order and cease and desist orders.
ADDRESSES: The complaint, except for any confidential information
contained therein, may be viewed on the Commission's electronic docket
(EDIS) at <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#50151419036318353c201025233924337e373f26"><span class="__cf_email__" data-cfemail="b0f5f4f9e383f8d5dcc0f0c5c3d9c4d39ed7dfc6">[email protected]</span></a>. Hearing impaired individuals are advised that
information on this matter can be obtained by contacting the
Commission's TDD terminal on (202) 205-1810. Persons with mobility
impairments who will need special assistance in gaining access to the
Commission should contact the Office of the Secretary at (202) 205-
2000. General information concerning the Commission may also be
obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>.
FOR FURTHER INFORMATION CONTACT: Susan Orndoff, The Office of Docket
Services, U.S. International Trade Commission, telephone (202) 205-
1802.
SUPPLEMENTARY INFORMATION:
Authority: The authority for institution of this investigation is
contained in section 337 of the Tariff Act of 1930, as amended, 19
U.S.C. 1337, and in section 210.10 of the Commission's Rules of
Practice and Procedure, 19 CFR 210.10 (2025).
Scope of Investigation: Having considered the complaint, the U.S.
International Trade Commission, on December 19, 2025, ordered that--
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of
1930, as amended, an investigation be instituted to determine whether
there is a violation of subsection (a)(1)(B) of section 337 in the
importation into the United States, the sale for importation, or the
sale within the United States after importation of certain products
identified in paragraph (2) by reason of infringement of one or more of
claims 1 and 16 of the '313 patent; claims 1,11, and 21 of the '314
patent; claims 1 and 9 of the '977 patent; claim 1 of the '321 patent;
claims 1, 12, and 20 of the '616 patent; and claims 1, 17, and 21 of
the '996 patent, and whether an industry in the United States exists as
required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of
Practice and Procedure, 19 CFR 210.10(b)(1), the plain language
description of the accused products or category of accused products,
which defines the scope of the investigation, is ``clear plastic
aligners used to treat misaligned teeth and bites, and components of
those aligners including the tri-layer material used to construct the
aligner'';
(3) For the purpose of the investigation so instituted, the
following are hereby named as parties upon which this notice of
investigation shall be served:
(a) The complainant is:
Align Technology, Inc., 410 North Scottsdale Road, Suite 1300, Tempe,
Arizona 85288
(b) The respondents are the following entities alleged to be in
violation of section 337, and are the parties upon which the complaint
is to be served:
Angelalign Technology Inc., 6/F-7/F, Building No. 7, KIC Business
Center, No. 500 Zhengli Road, Yangpu District, Shanghai, China
Wuxi EA Medical Instruments, Technologies Co., Ltd., No.1619, Huishan
Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu 214174, China
Wuxi EA Bio-Tech Co., Ltd., No. 36 Guanshan Road, Xinwu District, Wuxi,
Jiangsu 214000, China
Shanghai EA Medical Instruments Co., Ltd., Room 601-603, No. 500
Zhengli Road, Yangpu District, Shanghai 200433, China
USA Angelalign Technology Corp., 300 Creek View Rd Ste 209, Newark, DE
19711-8548
(3) For the investigation so instituted, the Chief Administrative
Law Judge, U.S. International Trade Commission, shall designate the
presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as
a party in this investigation.
Responses to the complaint and the notice of investigation must be
submitted by the named respondents in accordance with section 210.13 of
the Commission's Rules of Practice and Procedure, 19 CFR 210.13.
Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be
considered by the Commission if received not later than 20 days after
the date of service by the Commission of the complaint and the notice
of investigation. Extensions of time for submitting responses to the
complaint and the notice of investigation will not be granted unless
good cause therefor is shown.
Failure of a respondent to file a timely response to each
allegation in the complaint and in this notice may be deemed to
constitute a waiver of the right to appear and contest the allegations
of the complaint and this notice, and to authorize the administrative
law judge and the Commission, without further notice to the respondent,
to find the facts to be as alleged in the complaint and this notice and
to enter an initial determination and a final determination containing
such findings, and may result in the issuance of an exclusion order or
a cease and desist order or both directed against the respondent.
By order of the Commission.
Issued: December 19, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-23801 Filed 12-23-25; 8:45 am]
BILLING CODE 7020-02-P
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