Notice2025-20290
Prospective Grant of an Exclusive Patent License: Methods for the Diagnosis and Prognosis of Cancer
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 19, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Cancer Institute and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice to BioncoDx, LLC, a company organized in Delaware.
Full Text
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<title>Federal Register, Volume 90 Issue 221 (Wednesday, November 19, 2025)</title>
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[Federal Register Volume 90, Number 221 (Wednesday, November 19, 2025)]
[Notices]
[Pages 52080-52081]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20290]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Methods for the
Diagnosis and Prognosis of Cancer
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Cancer Institute and the National Institute of
Arthritis and Musculoskeletal and Skin Diseases, institutes of the
National Institutes of Health, Department of Health and Human Services,
are contemplating the grant of an Exclusive Patent License to practice
the inventions embodied in the patent applications listed in the
SUPPLEMENTARY INFORMATION section of this notice to BioncoDx, LLC, a
company organized in Delaware.
[[Page 52081]]
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center on or before December 4, 2025 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated an Exclusive Patent License
should be directed to: Todd Testerman, Ph.D., Technology Transfer
Manager, NCI Technology Transfer Center, Telephone: 240-620-0822;
Email: <a href="/cdn-cgi/l/email-protection#72061d16165c0617010617001f131c321c1b1a5c151d04"><span class="__cf_email__" data-cfemail="cbbfa4afafe5bfaeb8bfaeb9a6aaa58ba5a2a3e5aca4bd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. US Provisional Patent Application No. 61/845,055 filed July 11,
2013, and entitled ``Method for the Diagnosis And Prognosis of Cancer''
[HHS Reference No. E-121-2013-0-US-01];
2. International PCT Application No. PCT/US2014/046294 filed July
11, 2014, and entitled ``Method for the Diagnosis And Prognosis of
Cancer'' [HHS Reference No. E-121-2013-0-PCT-02];
3. US Patent No. 10,393,745 issued 8/27/2019, and entitled ``Method
for the Diagnosis And Prognosis of Cancer'' [HHS Reference No. E-121-
2013-0-US-04];
4. US Patent No. 11,555,818 issued 1/17/2023, and entitled ``Method
for the Diagnosis And Prognosis of Cancer'' [HHS Reference No. E-121-
2013-0-US-05];
5. Europe Patent No. 3019871 issued 10/16/2019, and entitled Method
for the Diagnosis And Prognosis of Cancer'' [HHS Reference No. E-121-
2013-0-EP-03];
6. German Patent No. 3019871 issued 10/16/2019, and entitled
``Method for the Diagnosis And Prognosis of Cancer'' [HHS Reference No.
E-121-2013-0-DE-06];
7. French Patent No. 3019871 issued 10/16/2019, and entitled
``Method for the Diagnosis And Prognosis of Cancer'' [HHS Reference No.
E-121-2013-0-FR-07]; and
8. United Kingdom Patent No. 3019871 issued 10/16/2019, and
entitled ``Method for the Diagnosis And Prognosis of Cancer'' [HHS
Reference No. E-121-2013-0-GB-08].
The patent rights in these inventions have been assigned to the
Government of the United States of America.
The prospective exclusive license territory may be worldwide where
patent rights exist and the field of use may be limited to the
following: ``Use of the Patent Rights to develop, manufacture and
commercialize a Food and Drug Administration (FDA) Premarket Approval
(PMA)--creatine riboside, metabolite 561+, cortisol sulfate, and N-
acetylneuraminic acid metabolite-based prognostic, diagnostic/companion
diagnostic, and general screening tests for cancers of the lung/
thoracic, breast, colorectal, kidney/bladder, prostate, liver, stomach,
pancreatic, GYN (ovary, uterine, cervix) and brain from urine
samples.'' After a negotiated period of time, the exclusive field of
use will be reduced to a subset of three cancer indications with strict
developmental benchmarks for each indication.
The subject technology is a unique, non-invasive screening tool and
diagnostic that can detect cancers, including lung cancer, at an early
stage utilizing liquid chromatography-mass spectrometry for the
detection of four biomarkers--creatine riboside, metabolite 561+,
cortisol sulfate, and N-acetylneuraminic acid--from human clinical
samples, particularly urine samples. Urine samples minimize patient
discomfort, unlike current early detection methods that are invasive,
such as blood or tissue biopsy or bronchoscopy, and can be performed
easily during a routine exam.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published notice, the National
Cancer Institute receives written evidence and argument that
establishes that the grant of the license would not be consistent with
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license that are timely filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive patent license. In response to this Notice,
the public may file comments or objections. Comments and objections,
other than those in the form of a license application, will not be
treated confidentially, and may be made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information in these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: November 17, 2025.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2025-20290 Filed 11-18-25; 8:45 am]
BILLING CODE 4140-01-P
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</html>Indexed from Federal Register on November 19, 2025.
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