[Federal Register Volume 82, Number 159 (Friday, August 18, 2017)]
[Notices]
[Pages 39443-39444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17438]


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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: Peter Soukas, J.D., (301) 594-8730; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at 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unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Development of a Transferrable Norwalk Virus Epitope and Detector 
Monoclonal Antibody

Description of Technology

    Noroviruses are now recognized as the major cause of non-bacterial 
gastroenteritis in all age groups, and efforts are underway to develop 
an effective vaccine. The lack of a robust cell culture system for 
human noroviruses has complicated vaccine development. Hence, norovirus 
virus like particles (VLPs) have played an important role in the 
understanding of virus structure, immune response, antigenic diversity, 
and vaccine design. The development of monoclonal antibodies (MAbs) 
against norovirus VLPs has allowed the identification and 
characterization of key antigenic sites of the virus capsid and 
facilitated the development of diagnostic assays. During 
characterization of a panel of MAbs raised against Norwalk virus (NV), 
a prototype norovirus strain, the inventors identified a monoclonal 
antibody (MAbNV10) that proved useful in the identification of NV in 
tissue and in the characterization of an insertion site in the feline 
calicivirus (FCV) genome. The inventors mapped the precise binding site 
of the MAb by peptide screening and discovered that the epitope could 
be expressed when fused to other proteins. The sequence of this peptide 
(epitope) along with the detector antibody could be used as a new way 
to tag proteins for functional studies. The small size of the linear 
epitope, along with the strong avidity of the detector monoclonal 
antibody makes this system especially useful for many techniques, 
including immunofluorescence, Western blot, immunoprecipitation 
(including ``pulldown'' assays), and immunohistochemistry. The 
inventors' epitope system may be comparable to that of the HA tag of 
influenza virus that is widely used in molecular biology.
    This technology is further described in Parra et al., ``Mapping and 
modeling of a strain-specific epitope in the Norwalk virus capsid inner 
shell,'' Virology. 2016 May;492:232-41. doi: 10.1016/
j.virol.2016.02.019. Epub 2016 Mar 21.
    Materials available for licensing comprise: (1) Hybridoma cell line 
NV10, (2) Plasmid expressing NV10 epitope as positive control, and (3) 
Plasmid expressing the NV10 scFV.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

 Diagnostics
 Vaccines

Competitive Advantages

 Cross-reactive norovirus antibody

[[Page 39444]]

 Ease of manufacture
 Efficient norovirus detection

Development Stage

 In vivo data available (animal)

    Inventors: Kim Green, Ph.D. (NIAID); Gabriel Parra, Ph.D. (NIAID); 
Stanislav Sosnovtsev, Ph.D. (NIAID); Karin Bok, Ph.D. (NIAID); Carlos 
Sandoval-Jaime, Ph.D. (NIAID); Eugenio Abente, Ph.D. (NIAID)
    Intellectual Property: HHS Reference No. E-101-2013/0.
    Licensing Contact: Peter Soukas, J.D., (301) 594-8730; 
[email protected]. 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 norovirus 
diagnostics or vaccines. For collaboration opportunities, please 
contact Peter Soukas, J.D., (301) 594-8730; [email protected].

    Dated: August 3, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-17438 Filed 8-17-17; 8:45 am]
BILLING CODE 4140-01-P