[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Page 50668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21767]


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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unpublished patent applications.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.

Recombinant RSV B1 Expressing eGFP as a Reporter Gene

    Description of Technology: The inventors have created a reverse 
genetics system for RSV strain B1 of antigenic subgroup B encoding a 
replication-competent recombinant RSV that contains a codon-optimized G 
ORF and expresses enhanced green fluorescence protein (GFP). There are 
two antigenic subgroups of RSV, subgroups A and B, and most of the 
available information and reagents are for subgroup A. Immunity against 
either subgroup has reduced effectiveness in restricting the 
heterologous subgroup, suggesting that an effective RSV vaccine might 
need to contain both subgroups. The sequence of the wild type G gene 
was refractory to cloning into full-length antigenomic cDNA in E. coli, 
and so the inventors made and successfully used a codon optimized 
version. In addition, the inventors inserted an eGFP gene into the 
first gene position (promoter proximal). The resulting virus is 
replication-competent and efficiently expresses GFP in infected cells. 
This virus can be used as a tool to detect RSV-neutralizing antibodies 
to RSV subgroup B in a plaque-reduction assay. It also can be used to 
evaluate RSV infection in vitro and in vivo using GFP fluorescence to 
track infection. The antigenomic cDNA clone also provides the starting 
material for making live-attenuated subgroup B-specific RSV vaccine 
candidates containing defined mutations. These defined mutations can 
include ones that we previously developed for RSV subgroup A, and 
include stabilized point mutations, stabilized codon-deletions, and 
gene-deletions.
    The present invention provides a reverse genetics system encoding 
strain B1 of RSV subgroup B containing a codon-optimized G ORF and 
encoding eGFP. This provides a tool for RSV subgroup B serology assays, 
for tracking RSV infection, and a starting point for making attenuated 
subgroup B strains for vaccine purposes.
    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:

 Viral diagnostics
 Vaccine research
 Serology assays
 Vaccine manufacture

    Competitive Advantages:

 Ease of manufacture
 Unique research tool

    Development Stage:

 In vitro data assessment

    Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID).
    Publications: None.
    Intellectual Property: HHS Reference No. E-159-2018-0.
    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 for development of a vaccine for 
respiratory or other infections. For collaboration opportunities, 
please contact Peter Soukas, J.D., 301-594-8730; [email protected].

    Dated: September 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-21767 Filed 10-5-18; 8:45 am]
BILLING CODE 4140-01-P