Notice2025-12391
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
July 2, 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 125 (Wednesday, July 2, 2025)</title>
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[Federal Register Volume 90, Number 125 (Wednesday, July 2, 2025)]
[Notices]
[Pages 29029-29030]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12391]
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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#1c7e7e7d757079655c717d757032727574327b736a"><span class="__cf_email__" data-cfemail="583a3a3931343d21183539313476363130763f372e">[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unpublished information related to the invention.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:
EV-D68 Monoclonal Antibodies Isolated From Immunized Rhesus Macaques
Description of Technology:
Enterovirus D68 (EV-D68) has been linked to the widespread
outbreaks of respiratory illness and acute flaccid myelitis (AFM) in
the United States and Europe in 2014, 2016, and 2018. Although EV-D68
is now the most frequently encountered enterovirus (41.1% of cases),
with an estimated global prevalence of 4%, there are no specific, FDA-
approved therapeutic interventions targeting this virus.
Researchers at the Vaccine Research Center (VRC) of the National
Institute of Allergy and Infectious Disease (NIAID) have identified
four monoclonal antibodies that potently bind and neutralize multiple
subclades of EV-D68, including B3 and A2 variants. Animal studies have
indicated that these Rhesus macaque-derived monoclonal antibodies
(mAbs) are likely to confer protection against respiratory illness in
young children (particularly those under age 5) and in individuals with
respiratory or immunocompromising conditions. Analyses conducted using
standard techniques such as cryo-EM have enabled the inventors to
further characterize the epitopes of two unique EV-D68-specific
antibodies, suggesting the value of this technology for developing
multi-specific approaches that confer broad protection against EV-D68.
Humanization and combination of these mAbs with other antibodies
exhibiting unique epitope specificities may prove beneficial for
therapeutic or prophylactic purposes, especially within the context of
a broader pandemic preparedness program. Further, these antibodies
could be incorporated into diagnostic assays/kits for the rapid and
accurate detection of EV-D68 in clinical or non-clinical settings.
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> Prevention or treatment of EV-D68 infection
<bullet> Development of diagnostic assays for rapid, accurate EV-
D68 detection in clinical and non-clinical settings
Competitive Advantages:
<bullet> Development of prophylactic or therapeutic interventions
against EV-D68 that effectively induce broad protection against
multiple circulating subclades
Development Stage: Preclinical
Inventors: Tracy Ruckwardt, Daniel Moss, Peter Krug, Masaru
Kanekiyo (all of NIAID VRC)
Relevant Publications: Krug et al. EV-D68 virus-like particle
vaccines elicit cross-clade neutralizing antibodies that inhibit
infection and block dissemination. Sci. Adv. 2023;9:eadg6076.
DOI:10.1126/sciadv.adg6076
Intellectual Property: HHS Reference No. E-041-2024; Provisional
Patent Application 63/640,619, filed on April 30, 2024, and PCT Patent
Application No. PCT/US2025/027110, filed on April 30, 2025.
Licensing Contact: To license this technology, please contact Brian
Bailey
[[Page 29030]]
at 240-669-5128, or <a href="/cdn-cgi/l/email-protection#7c1e1e1d151019053c111d151052121514521b130a"><span class="__cf_email__" data-cfemail="d1b3b3b0b8bdb4a891bcb0b8bdffbfb8b9ffb6bea7">[email protected]</span></a> and reference E-041-2024.
Dated: June 20, 2025.
Surekha Vathyam,
Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2025-12391 Filed 7-1-25; 8:45 am]
BILLING CODE 4140-01-P
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