Notice2025-10921
Government-Owned Inventions; Availability for Licensing
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
June 16, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Full Text
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25347-25348]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10921]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The invention listed below is owned by an agency of the U.S.
Government and is available for licensing to achieve expeditious
commercialization of results of federally funded research and
development. Foreign patent applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
FOR FURTHER INFORMATION CONTACT: Brian Bailey at 240-669-5128, or
<a href="/cdn-cgi/l/email-protection#41233328202f6f2320282d2438012f28296f262e37"><span class="__cf_email__" data-cfemail="ceacbca7afa0e0acafa7a2abb78ea0a7a6e0a9a1b8">[email protected]</span></a>. Licensing information may be obtained by
communicating with the Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852: tel. 301-496-2644. A signed
Confidential Disclosure Agreement will be required to receive copies of
unpublished information related to the invention.
SUPPLEMENTARY INFORMATION: Technology description follows:
Pan-GI Norovirus Monoclonal Antibody and Its Use
Description of Technology
Norovirus is a leading cause of vomiting, diarrhea, and foodborne
illness worldwide, with 700 million cases and 200,000 deaths occurring
each year. Despite decades of work in the field, there are no
preventive or therapeutic strategies specifically approved for even the
most prevalent forms of human norovirus (i.e., GI, GII genogroups),
which are highly contagious and carry an increased risk of severe
complications in children, older adults, and those with
immunocompromising conditions.
Researchers at the Vaccine Research Center of the National
Institute of Allergy and Infectious Diseases (NIAID) have isolated the
first broadly reactive monoclonal antibody against GI genogroup
noroviruses (mAbs16E10) using samples from a human blood donor. Results
of in vitro and in vivo analyses further supported the antibody's broad
binding and blocking specificity to the entire GI norovirus genogroup,
neutralization of the GI.1 type, and abrogation of infection in a non-
human primate challenge. These complementary findings highlight the
technology as a promising candidate for clinical applications,
including prophylaxis for at-risk populations, diagnostics, and the
development of candidate vaccines based on the newly discovered
epitope.
This technology is available for licensing for commercial
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
Potential Commercial Applications:
<bullet> Immunotherapy for immunocompromised populations
<bullet> Prophylactic treatment for at-risk populations
<bullet> Development of novel diagnostic, detection, and isolation
methods
<bullet> Development of vaccine candidates that effectively induce
broadly neutralizing antibodies with the potential to intervene against
multiple noroviruses within the GI genogroup
Competitive Advantages:
<bullet> First broadly reactive monoclonal antibody against GI
genogroup
<bullet> Exceptionally large binding epitope with high binding affinity
<bullet> Promising preliminary results in non-human primates
Development Stage: Preclinical.
Relevant Publications: Rimkute I, et al. A broadly protective human
antibody
[[Page 25348]]
for GI genogroup noroviruses. Nat Microbiol. 2025. <a href="https://doi.org/10.1038/s41564-025-01952-6">https://doi.org/10.1038/s41564-025-01952-6</a>.
Inventors: Mario Roederer, Inga Rimkute, Peter Kwong, Adam Olia,
Rafaello Verardi (all of NIAID VRC).
Intellectual Property: HHS Reference No. E-025-2024; Provisional
Patent Application 63/653,691, filed on May 30, 2024.
Licensing Contact: To license this technology, please contact Brian
Bailey at 240-669-5128 or <a href="/cdn-cgi/l/email-protection#d5b7a7bcb4bbfbb7b4bcb9b0ac95bbbcbdfbb2baa3"><span class="__cf_email__" data-cfemail="aeccdcc7cfc080cccfc7c2cbd7eec0c7c680c9c1d8">[email protected]</span></a>, and reference E-025-
2024.
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize this technology. For collaboration
opportunities, please contact Brian Bailey at 240-669-5128 or
<a href="/cdn-cgi/l/email-protection#690b1b000807470b0800050c1029070001470e061f"><span class="__cf_email__" data-cfemail="f1938398909fdf9390989d9488b19f9899df969e87">[email protected]</span></a>, and reference E-025-2024.
Dated: June 9, 2025.
Surekha Vathyam,
Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2025-10921 Filed 6-13-25; 8:45 am]
BILLING CODE 4140-01-P
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