Certain Balloon Dilation Devices, Systems, and Components Thereof; Notice of a 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 Remedy, the Public Interest, and Bonding; Extension of Target Date

Issuing agencies

Abstract

Notice is hereby given that the U.S. International Trade Commission has determined to review, in part, a final initial determination ("FID") of the presiding administrative law judge ("ALJ") finding a violation of section 337 of the Tariff Act of 1930, as amended. The Commission requests written submissions from the parties on 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. The Commission has also determined to extend the target date for completion of the above-captioned investigation to November 13, 2026.

Full Text

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<title>Federal Register, Volume 91 Issue 179 (Thursday, September 17, 2026)</title>
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[Federal Register Volume 91, Number 179 (Thursday, September 17, 2026)]
[Notices]
[Pages 58914-58916]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19045]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1449]


Certain Balloon Dilation Devices, Systems, and Components 
Thereof; Notice of a 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 Remedy, the Public 
Interest, and Bonding; Extension of 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 determined to review, in part, a final initial 
determination (``FID'') of the presiding administrative law judge 
(``ALJ'') finding a violation of section 337 of the Tariff Act of 1930, 
as amended. The Commission requests written submissions from the 
parties on 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. The Commission has also determined to extend the 
target date for completion of the above-captioned investigation to 
November 13, 2026.

FOR FURTHER INFORMATION CONTACT: Paul Lall, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-2043. 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#d693929f85e59eb3baa696a3a5bfa2b5f8b1b9a0"><span class="__cf_email__" data-cfemail="bffafbf6ec8cf7dad3cfffcaccd6cbdc91d8d0c9">[email&#160;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 May 23, 2025, the Commission instituted 
this investigation based on a complaint filed by Entellus Medical, Inc. 
of Plymouth, Minnesota; Stryker Corporation of Portage, Michigan; and 
Stryker Sales, LLC of Portage, Michigan (collectively, 
``Complainants''). 90 FR 22,116-17 (May 23, 2025). The complaint 
alleged violations of section 337 of the Tariff Act of 1930, as 
amended, 19 U.S.C. 1337 (``section 337'') based on the importation into 
the United States, the sale for importation, or the sale within the 
United States after importation of certain balloon dilation devices, 
systems, and components thereof by reason of infringement of one or 
more of claims 1-11, 14, 15, and 19-30 of U.S. Patent No. 11,083,878 
(``the '878 patent''); claims 1-16, 18-22, 24, 25, 27, 29, and 30 of 
U.S. Patent No. 11,090,472 (``the '472 patent''); and claims 1-4, 6-12, 
15-20, and 22 of U.S. Patent No. 12,274,847 (``the '847 patent''). Id. 
The Commission's notice of investigation named the following 
respondents: Fiagon GmbH of Hennigsdorf, Germany; Fiagon AG Medical 
Technologies of Hennigsdorf, Germany; Fiagon NA Corporation of Austin, 
Texas; Fiagon NA, LLC of Austin, Texas; and Hemostasis, LLC of White 
Bear Lake, Minnesota (collectively, ``Fiagon''). The Office of Unfair 
Import Investigations is

[[Page 58915]]

not participating in this investigation. Id.
    On September 8, 2025, the ALJ held a Markman hearing on claim 
construction, and on December 8, 2025, the ALJ issued Order No. 15 
construing certain claim terms. See Order No.15 (Dec. 8, 2025).
    On January 29, 2026, the Commission terminated the investigation as 
to claims 2-11, 15, 19, 21, and 24-30 of the '878 patent; claims 2-16, 
18-22, 24, 25, 27, 29, and 30 of the '472 patent; and claims 2-4, 6-10, 
12, 15-20, and 22 of the '847 patent. See Order No. 17 (Jan. 6, 2026), 
unreviewed by Comm'n Notice (Jan. 29, 2026).
    The ALJ held an evidentiary hearing on January 14-16 and 20-21, 
2026. As of the evidentiary hearing, the following claims remained in 
the investigation: claims 1, 14, 20, 22, and 23 of the '878 patent; 
claim 1 of the '472 patent; and claims 1 and 11 of the '847 patent 
(collectively, ``the Asserted Claims'').
    On June 26, 2026, the presiding ALJ issued the FID, finding a 
violation of section 337 in the importation into the United States, the 
sale for importation, and/or the sale in the United States after 
importation of certain balloon dilation devices, systems, and 
components thereof with respect to certain claims of the asserted 
patents. Specifically, the FID finds that: (1) Complainants have 
satisfied the importation requirement for the accused products; (2) 
Complainants have shown infringement as to claims 1, 14, 20, 22, and 23 
of the '878 patent, claim 1 of the '472 patent, and claims 1 and 11 of 
the '847 patent; (3) Fiagon has not shown invalidity as to claims 1, 
14, 20, 22, and 23 of the '878 patent, claim 1 of the '472 patent, or 
claims 1 and 11 of the '847 patent; (4) Fiagon has not shown that the 
'878, '472 are unenforceable; and (5) Complainants have satisfied the 
technical and economic prongs of the domestic industry requirement for 
the '878, '472, and '847 patents.
    The FID also includes a Recommended Determination on Remedy and 
Bonding (``RD''). Id. at 168-74. The RD recommends that the Commission 
issue a limited exclusion order and cease and desist orders against all 
respondents in the event the Commission finds a violation of section 
337. Id. at 168-72. The RD also recommends that the Commission impose a 
of 61% for certain accused products, but no bond for other accused 
products during the period of Presidential Review. Id. at 174.
    On July 27, 2026, Complainants submitted a public interest 
statement pursuant to Commission Rule 210.50(a)(4), 19 CFR 
210.50(a)(4). On the same day, Fiagon also submitted a public interest 
statement pursuant to Commission Rule 210.50(a)(4). On July 28, 2026, 
Congressman Bill Huizenga from Michigan submitted a letter responding 
to the Commission's July 2, 2026 notice in the Federal Register. See 91 
FR 40,588-89 (July 2, 2026). In addition, on July 29 and 30, 2026, 
Fiagon submitted separate letters from six doctors related to the 
public interest.
    On July 10, 2026, Fiagon filed a petition for review of several of 
the FID's findings concerning claim construction, whether the accused 
articles are ``articles that infringe,'' induced infringement, validity 
under the written description requirement, and obviousness. On July 17, 
2026, Complainants filed a response to Fiagon's petition.
    Having reviewed the record of the investigation, including the 
parties' petitions for review and related submissions, the Commission 
has determined to review the FID in part. Specifically, the Commission 
has determined to review the FID's findings that: (1) Complainants have 
satisfied the importation requirement for the accused products; (2) 
Complainants have established induced infringement of the Asserted 
Claims; (3) Fiagon failed to establish by clear and convincing evidence 
that any asserted claim is invalid for lack of written description 
under 35 U.S.C. 112; (4) Fiagon failed to establish by clear and 
convincing evidence that any asserted claim is invalid as obvious under 
35 U.S.C. 103; and (5) Complainants have satisfied the economic prong 
of the domestic industry requirement for the '878, '472, and '847 
patents.
    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). In connection with these findings, the Commission 
requests responses from the parties to the following questions:
    (1) Please explain whether and how the FID finds a violation of 
Section 337 based on Fiagon's own direct infringement of any Asserted 
Claim. Please discuss whether, including under the framework 
articulated by Commissioner Kearns in his Additional Views in Certain 
High-Density Fiber Optic Equipment and Components Thereof, Inv. No. 
337-TA-1194, the imported components (namely those combined with U.S.-
sourced components and assembled into complete VenSure devices/systems 
at Fiagon's site in Minnesota) should be considered articles that 
directly infringe the asserted claims of the '878 and '472 patents and 
therefore are ``articles that infringe'' under section 337. See FID at 
17-18; Certain High-Density Fiber Optic Equipment and Components 
Thereof, Inv. No. 337-TA-1194, Comm'n Op. at 98-104, Additional Views 
of Chair Kearns Regarding ``Articles that Infringe'' (Aug. 23, 2021).
    (2) Complainants argued before the ALJ that Fiagon takes actions to 
instruct or encourage physicians and healthcare facilities to use the 
Accused Products in a manner that constitutes direct infringement. The 
FID finds that the complaint, with its allegations of direct, induced, 
and contributory infringement, put Fiagon on notice of its 
infringement. Please identify evidence in the record showing that 
Fiagon took such actions after receipt of the complaint in this 
investigation.
    The parties are invited to brief only the discrete issues requested 
above, with reference to the applicable law and limited to arguments 
and evidence in the existing evidentiary record. The parties are not to 
brief other issues on review, which are adequately presented in the 
parties' existing filings.
    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. To the 
extent that any party in this investigation asserts that the proposed 
remedy would adversely impact the public interest, please identify and 
describe specific evidence supporting this assertion and where in

[[Page 58916]]

the record such evidence was first submitted to the ALJ. If such 
evidence was not submitted to the ALJ, please explain why the 
Commission should give such evidence any weight at this stage in the 
investigation.
    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: 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 RD by the ALJ on 
remedy and bonding.
    In its initial submission, Complainants are also requested to 
identify the remedy sought, and Complainants are requested to submit 
proposed drafts of remedial orders for the Commission's consideration. 
Complainants are 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. All initial written submissions, from the 
parties and/or third parties/interested government agencies, and 
proposed remedial orders from the parties must be filed no later than 
close of business on September 28, 2026. All reply submissions must be 
filed no later than the close of business on October 5, 2026. Opening 
submissions from the parties are limited to 50 pages. Reply submissions 
from the parties are limited to 25 pages. All submission from third 
parties and/or interested government agencies are limited to 10 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. The 
Commission's paper filing requirements in 19 CFR 210.4(f) are currently 
waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the 
investigation number (``Inv. No. 337-TA-1449'') in a prominent place on 
the cover page and/or the first page. (See Handbook for Electronic 
Filing Procedures, <a href="https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf">https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf</a>). 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 target date for completion of the investigation is extended to 
November 13, 2026. The Commission's vote on this determination took 
place on September 14, 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: September 14, 2026.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2026-19045 Filed 9-16-26; 8:45 am]
BILLING CODE 7020-02-P


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