Notice2026-11370
Certain Clear Aligners and Components Thereof; Notice of a Commission Determination Not To Review an Initial Determination Granting In Part a Motion To Amend the Complaint and Notice of Investigation
Primary source
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Published
June 8, 2026
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding chief administrative law judge's ("CALJ") initial determination ("ID") (Order No. 11) granting a motion to amend the complaint and notice of investigation ("NOI") to (1) add allegations of infringement of claim 24 for U.S. Patent No. 11,766,313 ("the `313 patent"); (2) add allegations of infringement of claim 28 for U.S. Patent No. 11,766,314 ("the `314 patent"); (3) add allegations of infringement of claims 2 and 14 for U.S. Patent No. 8,866,977 ("the `977 patent"); and (4) add allegations of infringement of claim 9 for U.S. Patent No. 10,980,616 ("the `616 patent").
Full Text
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<title>Federal Register, Volume 91 Issue 109 (Monday, June 8, 2026)</title>
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[Federal Register Volume 91, Number 109 (Monday, June 8, 2026)]
[Notices]
[Pages 34651-34652]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11370]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1471]
Certain Clear Aligners and Components Thereof; Notice of a
Commission Determination Not To Review an Initial Determination
Granting In Part a Motion To Amend the Complaint and Notice of
Investigation
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 determined not to review the presiding chief
administrative law judge's (``CALJ'') initial determination (``ID'')
(Order No. 11) granting a motion to amend the complaint and notice of
investigation (``NOI'') to (1) add allegations of
[[Page 34652]]
infringement of claim 24 for U.S. Patent No. 11,766,313 (``the `313
patent''); (2) add allegations of infringement of claim 28 for U.S.
Patent No. 11,766,314 (``the `314 patent''); (3) add allegations of
infringement of claims 2 and 14 for U.S. Patent No. 8,866,977 (``the
`977 patent''); and (4) add allegations of infringement of claim 9 for
U.S. Patent No. 10,980,616 (``the `616 patent'').
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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#51141518026219343d211124223825327f363e27"><span class="__cf_email__" data-cfemail="591c1d100a6a113c3529192c2a302d3a773e362f">[email protected]</span></a>. 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>. Hearing-impaired persons are advised that information on
this matter can be obtained by contacting the Commission's TDD
terminal, telephone (202) 205-1810.
SUPPLEMENTARY INFORMATION: On December 29, 2025, the Commission
instituted this investigation based on a complaint filed by Align
Technology, Inc. of Tempe, Arizona (``Align''). 90 FR 245 (Dec. 29,
2025). The complaint alleged violations of section 337 of the Tariff
Act of 1930, as amended, based on the importation into the United
States, the sale for importation, or the sale within the United States
after importation of certain clear aligners and components thereof 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 U.S. Patent No. 12,059,321; claims 1, 12, and
20 of the `616 patent; and claims 1, 17, and 21 of U.S. Patent No.
11,490,996 (``the `996 patent''). Id. The Commission's notice of
investigation named the following respondents: Angelalign Technology
Inc. of Shanghai, China; Wuxi EA Medical Instruments of Jiangsu, China;
Wuxi EA Bio-Tech Co., Ltd. of Jiangsu, China; Shanghai EA Medical
Instruments Co. of Shanghai, China; and USA Angelalign Technology Corp.
of Newark, Delaware (collectively, ``Respondents''). The Office of
Unfair Import Investigations is not participating in this
investigation. Id.
On April 14, 2026, Align moved under 19 CFR 210.14 to amend the
complaint and NOI to (1) withdraw allegations of infringement of claim
16 and add allegations of infringement of claim 24 for the `313 patent;
(2) withdraw allegations of infringement of claim 21 and add
allegations of infringement of claim 28 for the `314 patent; (3)
withdraw allegations of infringement of claims 1 and 9 and add
allegations of infringement of claims 2 and 14 for the `977 patent; (4)
withdraw allegations of infringement of claim 1 and add allegations of
infringement of claim 9 for the `616 patent; and (5) withdraw
allegations of infringement of all asserted claims, claims 1, 17, and
21, of the '996 patent. Id. at 1-2. Align argued that good cause exists
for this amendment because it promptly moved to add the new claims
after it received Respondents technical information and inspected
Respondents' treatment plans and determined it had sufficient
information to assert the new claims in good faith. Align further
argued that terminating claims would narrow the case and streamline the
investigation. Id. at 3. Respondents opposed the motion, arguing that
`` Align had all the information it needed to assert the New Claims
when it filed the Complaint in September 2025, and chose not to do
so.'' Id. at 4. Respondents further argued that `` `Align's purported
narrowing of its own case is illusory' in that the new claims `depend
directly or indirectly from the independent claims Align purports to
remove' and thus `the limitations of the independent claims purportedly
being removed are still part of this Investigation.' '' Id. at 3.
On March 7, 2022, the CALJ issued the subject ID, granting the
motion but only as to adding the new claims. The ID observed that
Commission Rule 210.14(b) proves in part that
[a]fter an investigation has been instituted, the complaint and notice
of investigation may be amended only by leave of the Commission for
good cause shown and upon such conditions as are necessary to avoid
prejudicing the public interest and the rights of the parties to the
investigation.
Id. at 2 (citing 19 CFR 210.14(b)). The ID found that good cause
exists to amend the complaint and NOI to add the new claims because
``adjudicating the proposed claims here--rather than postponing them to
subsequent litigation--will be a more efficient use of judicial and
party resources.'' Id. at 4. The ID also found that Respondents were
``on notice that Align intended to assert the new claims at least as
early as February 27, 2026, when it received Align's initial responses
to contention interrogatories'' and ``will have had time to explore
defenses before the close of fact discovery on May 7, 2026, and the
close of expert discovery on June 15, 2026.'' Id. The ID denied Align's
motion to withdraw claims because Align did not comply with Commission
Rules for terminating claims. Id. (citing 19 CFR 210.21(a)(1)).
On May 11, 2026, Respondents filed a petition for review
challenging the ID's finding that Align showed good cause to amend the
complaint and NOI. On May 18, 2026, Align filed a response to
Respondents' petition.
Having reviewed the current record of the investigation, including
the ID, the parties' submissions to the CALJ, the petitions for review,
and the responses thereto, the Commission has determined not to review
the subject ID. The Commission notes that Align is adding allegations
of infringement with respect to dependent claims found in patents that
are already asserted in the investigation. Moreover, Align timely moved
to add these claims after it received technical information necessary
to evaluate infringement of the new claims. See ID at 4. In addition,
Align has stated that it is amenable to Respondents supplementing their
contention interrogatory responses and other adjustments ``to address
the Dependent Claims'' added by the amendment. Id. The Commission
further notes that nothing prevents the Respondents from petitioning
the CALJ to extend the time to accommodate the newly asserted dependent
claims if necessary. The following claims have been added to the
investigation: (1) claim 24 of the `313 patent; (2) claim 28 of the
`314 patent; (3) claims 2 and 14 of the `977 patent; and (4) claim 9 of
the `616 patent.
The Commission vote for this determination took place on June 3,
2026.
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, 2026.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2026-11370 Filed 6-5-26; 8:45 am]
BILLING CODE 7020-02-P
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