Notice2025-09340
Certain Balloon Dilation Devices, Systems, and Components Thereof; Notice of Institution of Investigation
Primary source
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Published
May 23, 2025
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 18, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of Entellus Medical, Inc. of Plymouth, Minnesota, Stryker Corporation of Portage, Michigan, and Stryker Sales, LLC of Portage, Michigan. Supplements to the complaint were filed on April 25 and May 8, 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 balloon dilation devices, systems, and components thereof by reason of the infringement of certain claims of U.S. Patent No. 11,083,878 ("the '878 patent"); U.S. Patent No. 11,090,472 ("the '472 patent"); and U.S. Patent No. 12,274,847 ("the '847 patent"). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute. The complainants request 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 99 (Friday, May 23, 2025)</title>
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[Federal Register Volume 90, Number 99 (Friday, May 23, 2025)]
[Notices]
[Pages 22116-22117]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09340]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1449]
Certain Balloon Dilation Devices, Systems, and Components
Thereof; Notice of 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 April 18, 2025, under section
337 of the Tariff Act of 1930, as amended, on behalf of Entellus
Medical, Inc. of Plymouth, Minnesota, Stryker Corporation of Portage,
Michigan, and Stryker Sales, LLC of Portage, Michigan. Supplements to
the complaint were filed on April 25 and May 8, 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 balloon
dilation devices, systems, and components thereof by reason of the
infringement of certain claims of U.S. Patent No. 11,083,878 (``the
'878 patent''); U.S. Patent No. 11,090,472 (``the '472 patent''); and
U.S. Patent No. 12,274,847 (``the '847 patent''). The complaint further
alleges that an industry in the United States exists or is in the
process of being established as required by the applicable Federal
Statute. The complainants request 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#ca8f8e8399f982afa6ba8abfb9a3bea9e4ada5bc"><span class="__cf_email__" data-cfemail="70353439234338151c003005031904135e171f06">[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 the
Secretary, Docket Services Division, 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 May 20, 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 1-11, 14-15, and 19-30 of the '878 patent; claims 1-16, 18-22,
24-25, 27, and 29-30 of the '472 patent; and claims 1-4, 6-12, 15-20,
and 22 of the '847 patent, and whether an industry in the United States
exists or is in the process of being established 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 ``(a) balloon dilation
devices; (b) systems containing the same for tracking, guiding,
illumination, and/or navigating cavities, and (c) components thereof
consisting of: (i) components of the balloon dilation device; and (ii)
components for tracking, guiding, illuminating, and/or navigating used
in balloon dilation devices and with systems containing the same'';
(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 complainants are:
Entellus Medical, Inc., 3600 Holly Lane North, Suite 40, Plymouth,
Minnesota 55447
Stryker Corporation, 1941 Stryker Way, Portage, Michigan 49002
Stryker Sales, LLC, 1941 Stryker Way, Portage, Michigan 49002
(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:
Fiagon GmbH, Neuendorfstra[szlig]e 23b, 16761 Hennigsdorf, Germany
[[Page 22117]]
Fiagon AG Medical Technologies, Neuendorfstra[szlig]e 23b, 16761
Hennigsdorf, Germany
Fiagon NA Corporation, 3913 Todd Ln., Building 100, Suite 101, Austin,
Texas 78744
Fiagon NA, LLC, 3913 Todd Ln., Building 100, Suite 101, Austin, Texas
78744
Hemostasis, LLC, 5000 Township Pkwy., White Bear Lake, Minnesota 55110
(4) 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: May 20, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-09340 Filed 5-22-25; 8:45 am]
BILLING CODE 7020-02-P
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