[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58817-58818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26937]


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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: Dr. Natalie Greco, 301-761-7898; 
[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unpublished patent applications.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.

Monoclonal Antibody Specific for DNA/RNA Hybrid Molecules

Description of Technology

    NIAID has a hybridoma available for non-exclusive licensing that 
produces a monoclonal antibody specific for DNA/RNA hybrids. This 
antibody, which has been extensively characterized by NIH researchers, 
is already a widely-used research tool. It is currently the only 
monoclonal antibody available that is specific for DNA/RNA hybrids, 
making it a unique reagent. It is used in immuno-fluorescence (IF) 
microscopy, where it can be used to detect sites of transcriptional 
activity and potentially sites of viral replication. It has also been 
used in DNA/RNA immunoprecipitation (DRIP) experiments by a variety of 
researchers.
    Aside from its use as a research tool, this antibody has potential 
to be used in diagnostic kits for viral/bacterial infections, cancers, 
and a variety of other human diseases. DNA/RNA hybrids arise during 
normal cellular function, but they are typically present in cells at 
low levels. When DNA/RNA hybrids are found at high levels in a cell, it 
indicates that the cell is ``abnormal''. For example, the cell may be 
cancerous or infected with a virus. NIH researchers have also 
incorporated the antibody into a micro-array platform, expanding its 
potential for use in diagnostic devices.
    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.

[[Page 58818]]

Potential Commercial Applications

    Research tool:

 Detection and visualization of DNA/RNA hybrids, ``R-loops'', 
or sites of viral replication in cells
 DNA/RNA immunoprecipitation (DRIP) studies
 Antibody based micro-arrays

    For use in diagnostic kits that detect:

 Viral/bacterial infections
 miRNA biomarkers of disease (i.e. certain cancers)

Competitive Advantages

 Only available monoclonal antibody specific for DNA/RNA 
hybrids
 Binding properties extensively characterized by NIH 
researchers
 Widely-accepted as a key research reagent
 Antibody based micro-arrays are inexpensive, efficient, and 
increase detection of small or structured transcripts, as well as 
transcripts present at low levels

Development Stage

 in vitro data available

Inventors

    S. Leppla, C. Leysath, D. Phillips, D. Garboczi, L. Lantz (all of 
NIAID).

Publications

 Phillips DD, et al. (2013)--PMID: 23784994--PMCID: 
PMC4061737--The sub-nanomolar binding of DNA-RNA hybrids by the single-
chain Fv fragment of antibody S9.6
 Hu Z, et al. (2006)--PMID: 16614443--PMCID: PMC1435976--An 
antibody-based microarray assay for small RNA detection

    Intellectual Property: HHS Reference No. E-738-2013
    Licensing Contact: Dr. Natalie Greco, 301-761-7898; 
[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 antibodies produced by the S9.6 
hybridoma. For collaboration opportunities, please contact Dr. Natalie 
Greco, 301-761-7898; [email protected].

    Dated: December 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-26937 Filed 12-13-17; 8:45 am]
BILLING CODE 4140-01-P