Notice2021-12181
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 10, 2021
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 86 Issue 110 (Thursday, June 10, 2021)</title>
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[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30964-30965]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12181]
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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: Benjamin Hurley; tel. 240-669-5092;
<a href="/cdn-cgi/l/email-protection#0163646f6b606c686f2f6974736d6478416f68692f666e77"><span class="__cf_email__" data-cfemail="bad8dfd4d0dbd7d3d494d2cfc8d6dfc3fad4d3d294ddd5cc">[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unpublished information related to the invention.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:
FRugally Optimized DNA Octamer (FRODO): DNA Vector and Uses Thereof for
Detecting HIV and SIV
Description of Technology
Quantitative polymerase chain reactions (qPCRs) are commonly
employed to enumerate genes of interest among particular biological
samples. Insertion of PCR amplicons into plasmid DNA is a mainstay for
creation of known quantities of target sequences to standardize
quantitative PCRs. Typically, one amplicon is inserted into one plasmid
construct, the plasmid is then amplified, purified, serially diluted,
and then quantified to be used to enumerate target sequences in unknown
samples. As qPCR is often used to detect multiple amplicons
simultaneously, individual qPCR standards are often desired to be
normalized one to another. Unlike prior methods using separate plasmid
constructs for each target sequence, FRODO incorporates eight amplicons
into one plasmid construct ensuring equivalent template copy numbers
for all amplicons. Amplifying, purifying, diluting and quantifying one
plasmid construct rather than eight individual constructs streamlines
standard curve qPCR analyses, reducing reagents and simplifying
normalization between amplicons.
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
<bullet> Clinical Detection, Monitoring of Nucleic Acid Markers of
HIV and Immunological Health: FRODO may be used to efficiently quantify
target sequences in unknown samples.
<bullet> FRODO is a single plasmid containing 8 amplicons which can
be used to quantify several different strains of SIV and HIV, cell
number equivalents for humans and nonhuman primates, T cell receptor
excision circles (humans and nonhuman primates), and bacterial 16S and
ampicillin resistance DNA.
<bullet> FRODO may offer improved, more affordable, highly-
sensitive nucleic acid-based HIV quantification and/or diagnostic
response times, enhancing patient treatment and interventions.
<bullet> FRODO can be used to quantify levels of bacterial DNA in
clinical samples to determine potential sepsis.
<bullet> This technology is especially useful in translational HIV
research in which human and nonhuman primate models are used to study
HIV pathogenesis, informing public health responses.
Competitive Advantages
<bullet> A simplified workflow for qPCR testing. Amplifying,
purifying, diluting and quantifying one plasmid construct rather than
multiple, individual constructs streamlines standard curve qPCR
analyses, reducing reagents and simplifying normalization between
amplicons.
<bullet> At present, there are a number of antibody-based clinical
tools that may be used for diagnosing/detecting HIV, but there are
fewer products that affordably detect/monitor nucleic acids of HIV
within cells, and immunological health, and efficacy of medicaments
[[Page 30965]]
aimed at reducing cells infected with HIV.
Inventors: Jason Brenchley and Charlotte Langner, both of NIAID.
Publications: Langer, Charlotte A. and Brenchley, Jason M.;
Frugally Optimized DNA Octomer (FRODO) qPCR Measurement of HIV and SIV
in Human and Nonhuman Primate Samples; Current Protocols, 2021.
Intellectual Property: HHS Reference No. E-024-2021; US Provisional
Application No. 63/128,392.
Licensing Contact: To license this technology, please contact
Benjamin Hurley at 240-669-5092 or <a href="/cdn-cgi/l/email-protection#debcbbb0b4bfb3b7b0f0b6abacb2bba79eb0b7b6f0b9b1a8"><span class="__cf_email__" data-cfemail="7517101b1f14181c1b5b1d000719100c351b1c1d5b121a03">[email protected]</span></a>, and
reference E-024-2021.
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 invention. For collaboration
opportunities, please contact Benjamin Hurley; 240-669-5092,
<a href="/cdn-cgi/l/email-protection#bcded9d2d6ddd1d5d292d4c9ced0d9c5fcd2d5d492dbd3ca"><span class="__cf_email__" data-cfemail="1b797e75717a76727535736e69777e625b757273357c746d">[email protected]</span></a>.
Dated: June 2, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-12181 Filed 6-9-21; 8:45 am]
BILLING CODE 4140-01-P
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