[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16348-16351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06404]
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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 inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 209 and 37 CFR part 404 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: Licensing information and copies of
the U.S. patent applications listed below may be obtained by writing to
the indicated licensing contact at the Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to
receive copies of the patent applications.
Discovery of Novel PARP Inhibitors That Synergize With Topoisomerase I
Inhibitors for Cancer Treatment
Description of Technology: Scientists at the NCI discovered new
inhibitors of poly ADP ribose polymerase (PARP). These inhibitors can
synergize with topoisomerase I (Top 1) inhibitors, such as camptothecin
(CPT), as well as with other cancer therapeutic agents, such as DNA
alkylating agents (temozolomide), to enhance the efficacy of current
anticancer treatments. The mechanism of action is inhibition of DNA
repair mechanism. PARP is a partner of trosyl-DNA phosphodiesterase I
(TDP1), a DNA repair enzyme inside the XRCC1 multiprotein-DNA repair
complex.
Potential Commercial Applications:
Used in combination therapy with approved cancer therapeutic
agents
Treatment for BRCA- and homologous repair-deficient cancers
Competitive Advantages: Should boost the efficacy of current anti-
cancer treatments
Development Stage: In vitro data available
Inventors: Chrisophe R. Marchand, J. Murai, Yves G. Pommier (all of
NCI)
Publications:
1. Maxwell KN, Domchek SM. Cancer treatment according to BRCA1 and
BRCA2 mutations. Nat Rev Clin Oncol. 2012 Sep;9(9):520-8. [PMID
22825375]
2. Marchetti C, et al. Olaparib, PARP1 inhibitor in ovarian cancer.
Expert Opin Investig Drugs. 2012 Oct;21(10):1575-84. [PMID 22788971]
3. Ellisen LW. PARP inhibitors in cancer therapy: Promise, progress
and puzzles. Cancer Cell. 2011 Feb 15; 19(2):165-7. [PMID 21316599]
4. Papeo G, et al. Poly(ADP-ribose) polymerase inhibition in cancer
therapy: Are we close to maturity? Expert Opin Ther Pat. 2009
Oct;19(10):1377-400. [PMID 19743897]
Intellectual Property: HHS Reference No. E-075-2014/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technology: HHS Reference No. E-199-2010/0--US Patent
Application No. 13/293,282 filed 27 Oct 2011 (allowed)
Licensing Contact: Uri Reichman, Ph.D., MBA; 301-435-4616;
[email protected]
Deconvolution Software for Modern Fluorescence Microscopy
Description of Technology: This software invention pertains to
Joint Richardson-Lucy (RL) deconvolution methods used to combine
multiple images of an object into a single image for improving
resolution in modern fluorescence microscopy. RL deconvolution merges
images with very different point spread functions, such as in multi-
view light-sheet microscopes, while preserving the best resolution
information present in each image. RL deconvolution is also easily
applied to merge high-resolution, high noise
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images with low-resolution, low noise images, relevant when
complementing conventional microscopy with localization microscopy. The
technique can be performed on images produced via different simulated
illumination patterns, relevant to structured illumination microscopy
(SIM) and image scanning microscopy (ISM) resulting in image qualities
at least as good as standard inversion algorithms, but follows a
simpler protocol that requires little mathematical insight. RL
deconvolution can also be used to merge a series of several images with
varying signal and resolution levels. This combination is relevant to
gated stimulated-emission depletion (STED) microscopy and shows that
high-quality image merges are possible even in cases where no explicit
inversion algorithm is known.
Potential Commercial Applications: Microscopy
Competitive Advantages: High image precision for fast moving
samples
Development Stage:
Early-stage
In vitro data available
Inventors: George H. Patterson, Maria DM Ingaramo, Andrew York,
Hari Shroff (all of NIBIB)
Publications:
1. Richardson, William Hadley. Bayesian-Based Iterative Method of
Image Restoration. J Opt Soc Am. 1972;62 (1): 55-9. [http://dx.doi.org/10.1364/JOSA.62.000055]
2. Wu Y, et al. Volumetric Isotropic Imaging with Dual-view Plane
Illumination Microscopy. Nat Biotechnol., in press.
3. Lucy LB. An iterative technique for the rectification of observed
distributions. Astron J. 1974;79(6):745-54. [http://dx.doi.org/10.1086/111605]
Intellectual Property: HHS Reference No. E-038-2014/0--Software
Materials. Patent protection is not being pursued for this technology.
Related Technologies: HHS Reference No. E-005-2012/2--PCT
Application No. PCT/US2013/27413 filed 22 Feb 2013, which published as
WO 2013/126762 on 29 Aug 2013 (claiming priority to 23 Feb 2012)
Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019;
[email protected]
Collaborative Research Opportunity: The National Institute of
Biomedical Imaging and Bioengineering is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize Multifocal High
Resolution Microscopy. For collaboration opportunities, please contact
Henry Eden, M.D., Ph.D. at [email protected] or 301-435-1953.
Human Influenza Virus Real-Time RT-PCR: Detection and Discrimination of
Influenza A (H3N2) Variant From Seasonal Influenza A (H3N2) Viruses,
Including H3v and Seasonal H3 Assays
Description of Technology: This invention relates to methods of
rapidly detecting influenza, including differentiating between type and
subtype. CDC researchers have developed a rapid, accurate, real-time
RT-PCR assay that has several advantages over culture and serological
tests, which require 5 to 14 days for completion; this assay can also
be easily implemented in kit form. To date, hundreds of human cases of
infection with the H3N2 variant virus have been confirmed. The
increased numbers of human infection of H3N2 variant virus has led to a
need for a highly sensitive and specific assay for the diagnosis and
confirmation of the H3N2 variant virus.
Potential Commercial Applications:
Influenza diagnostic using clinical specimens
High-throughput sample screening
Government, regional influenza surveillance programs
Competitive Advantages:
Especially useful for H3N2 screening
Sensitive detection
Specific discrimination of influenza subtypes
Easily formatted as kit or array
Faster than culturing and serological identification methods
Less laborious and more objective than immunoassays
Development Stage: In vitro data available
Inventors: Bo Shu, Stephen Lindstrom, Kai-Hui Wu, LaShondra Berman
(all of CDC)
Publications:
1. Lindstrom S, et al. Human infections with novel reassortant
influenza A(H3N2)v viruses, United States, 2011. Emerg Infect Dis.
2012 May;18(5):834-7. [PMID 22516540]
2. Cox CM, et al. Swine influenza virus A (H3N2) infection in human,
Kansas, USA, 2009. Emerg Infect Dis. 2011 Jun;17(6):1143-4. [PMID
21749798]
3. Jhung MA, et al. Outbreak of variant influenza A(H3N2) virus in
the United States. Clin Infect Dis. 2013 Dec;57(12):1703-12. [PMID
24065322]
Intellectual Property: HHS Reference No. E-562-2013/0--US Patent
Application No. 61/894,291 filed 22 Oct 2013
Related Technologies:
HHS Reference No. E-274-2013/0
HHS Reference No. E-331-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Improved Methods To Measure Hyaluronan Acid
Description of Technology: The invention is directed to an improved
method for measuring the amount of hyaluronan acid (HA) in a biological
sample using an ELISA based system. HA is a disaccharide polymer that
is expressed at elevated levels in patients afflicted with certain
autoimmune diseases, including Graves' ophthalmopathy and rheumatoid
arthritis. The amount and the length of HA present in a patient sample
varies.
When compared to existing assays, the invention assay provides a
more accurate and sensitive way to measure HA. Specifically, the first
step in the invention assay involves determining the size range of the
average molecular weight of HA in the sample. Next, the amount of HA in
the sample is quantified using an ELISA system wherein HA binds to
hyaluronan binding protein (HABP). Then, the binding results are
compared against a control sample containing HA at an average molecular
weight similar to that of HA in the sample being tested. Thus, the
invention assay takes into account two variables that lead to
significant errors in calculating the concentration of HA in a
biological sample: (1) The wide range of HA particle sizes in a sample,
and (2) differing binding efficiencies between HABP and HA at different
particle sizes.
Potential Commercial Applications:
Diagnostic Test
Personalized Medicine
Competitive Advantages: More accurate and sensitive quantification
of HA in biological samples when compared to commercially available
ELISA kits.
Development Stage:
Early-stage
In vitro data available
Prototype
Inventors: Marvin C. Gershengorn and Christine C. Krieger (NIDDK)
Publication:
Krieger CC, Gershengorn MC. A modified ELISA accurately measures
secretion of high molecular weight hyaluronan (HA) by Graves'
disease orbital cells. Endocrinology. 2014 Feb;155(2):627-34. [PMID
24302624]
Intellectual Property: HHS Reference No. E-538-2013/0-US-01--US
Application No. 61/860,722 filed 31 Jul 2013
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; [email protected]
[[Page 16350]]
Human iPSC-Derived Mesodermal Precursor Cells and Differentiated Cells
Description of Technology: Cells, cell culture methods, and cell
culture media compositions useful for producing and maintaining iPSC-
derived cell lines that are of higher purity and maintain cell type
integrity better than current iPSC-derived cell lines are disclosed.
Human induced pluripotent stem cells (hiPSCs) can be generated by
reprogramming somatic cells by the expression of four transcription
factors. The hiPSCs exhibit similar properties to human embryonic stem
cells, including the ability to self-renew and differentiate into all
three embryonic germ layers: Ectoderm, endoderm, or mesoderm. Human
iPSCs can be induced into any cell type and, since they can be
maintained over many passages, they can serve as an almost unlimited
source to generate cells from any given person. These properties make
iPSC-derived cells a valuable product for cell therapies and toxicology
or pharmaceutical high throughput screens. NIH investigators disclose
an iPSC-derived mesodermal precursor cell line, positive for CD34 and
CD31 expression, that may be used to produce at least four different
cell types. When cultured under appropriate conditions, these
mesodermal precursor cells can be used to produce hematopoietic stem
cells, mesenchymal stem cells, smooth muscle cells, or unlimited
functional endothelial cells.
Potential Commercial Applications:
The iPSC-derived mesodermal precursor cell (MPC) line
described here can be used to produce hematopoietic stem cells,
mesenchymal stem cells, smooth muscle cells, or unlimited functional
endothelial cells.
The differentiated cells produced using the disclosed methods
and MPC can be used for screening, as well as therapeutic applications.
Competitive Advantages: The mesodermal precursor cells have the
ability to maintain their phenotype for extended periods without
differentiating, when maintained under appropriate conditions.
Development Stage:
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Drs. Manfred Boehm (NHLBI), Guibin Chen (NHLBI),
Mahendra Rao (NIAMS), and Andr[eacute] Larochelle (NHLBI)
Intellectual Property: HHS Reference No. E-342-2013/0--US
Provisional Application No. 61/885,209 filed 01 Oct 2013
Related Technologies:
HHS Reference No. E-762-2013/0--US Provisional Application No.
61/904,999 filed 15 Nov 2013
HHS Reference No. E-763-2013/0--US Provisional Application No.
61/905,002 filed 15 Nov 2013
Licensing Contact: Sury Vepa, Ph.D., J.D.; 301-435-5020;
[email protected]
Collaborative Research Opportunity: The National Heart, Lung, and
Blood Institute is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize this technology. For collaboration
opportunities, please contact Denise Crooks at [email protected].
Silica Exposure Safety: Mini-Baghouse Systems and Methods for
Controlling Particulate Release From Large Sand Transfer Equipment
Description of Technology: CDC scientists have developed an
effective control for release of silica-containing dusts by using
retrofitted mini baghouses for thief hatches on sand transfer trucks.
Retrofit of the mini baghouses on sand transfer trucks will
significantly reduce silica dust release and silica exposures in the
workplace and surrounding community.
In the U.S., virtually every new oil and gas well is hydraulically
fractured (HF) to stimulate well production. Each HF operation has 2-4
sand transfer trucks in use, and tens of thousands of pounds of sand
are used for each stage of each multi-stage fracturing. Currently,
there are no truck-mounted engineering controls for silica release at
HF operations, posing an elevated risk of silica exposure to personnel
and surrounding areas. CDC results have shown that silica workplace
exposures at HF sites are completely uncontrolled at present (with the
exception of personal respirator use), and silica exposures are likely
to be the most significant and hazardous occupational chemical exposure
on HF sites. Additionally, CDC field research has shown that personal
breathing zone silica concentrations regularly exceed the maximum use
concentration for both half-mask and full-face air purifying
respirators. Use of this mini baghouse technology (multiple mini
baghouse retrofits to sand trucks) will serve to limit release of
silica dust, thereby diminishing silica exposure and increasing safety.
Potential Commercial Applications:
Controlling occupational exposure to silica, especially for
work involving sand transfer trucks
Retrofitting currently operating heavy equipment
Gas and oil well-workers' well-being concern groups
Hydraulic fracturing operations situated near populated areas
and associated insurers
Occupationally-mandated pneumoconiosis, and/or silicosis
prevention programs for complying with safety regulations
Competitive Advantages:
Designed for retrofitting ``thief hatches'' of existing
machinery
This technology will reduce silica exposure near hydraulic
fracturing sites, helping to diminish one of the most hazardous
exposure risks of such operations
Provides previously unavailable truck mounted engineering
controls for silica release at hydraulic fracturing operations
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Eric J. Esswein, Michael Breitenstein, John E. Snawder,
Michael G. Gressel, Jerry L. Kratzer (all of CDC)
Intellectual Property: HHS Reference No. E-291-2013/0--US
Application No. 13/802,265 filed 13 Mar 2013
Related Technologies:
HHS Reference No. E-312-2013/0
HHS Reference No. E-498-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Dengue Vaccines: Tools for Redirecting the Immune Response for Safe,
Efficacious Dengue Vaccination
Description of Technology: This CDC-developed invention relates to
dengue vaccines that have been specifically developed for improved
efficacy and directed immune response to avoid antibody-dependent
enhancement (ADE) safety issues that, theoretically, may be associated
with dengue vaccines and vaccinations. Dengue viral infection typically
causes a debilitating but non-lethal illness in hosts. However, dengue
hemorrhagic fever (DHF), the much more severe and life-threatening
condition, is generally attributed to secondary dengue infections
caused by a serotype different from the initial infection serotype by
way of ADE. This effect, particularly notable in dengue viruses, should
be given special consideration during vaccine design and construction.
This in vivo-validated technology provides a strategy and mechanism
for increasing the safety of dengue vaccines and diminishing the
likelihood of such
[[Page 16351]]
vaccines inadvertently harming a recipient due to ADE-mediated effects.
Any safe, effective dengue vaccine must produce well-balanced and
tetravalent (for all four dengue serotypes) protective immunity.
Despite decades of investigative effort there remains no effective,
commercially available dengue vaccine and the greatest hurdle has been
the difficulty of rapidly inducing this balanced immunity to all four
dengue serotypes.
With this invention, CDC researchers have developed a cross-
reactivity reduced dengue serotype 1 (DENV-1) DNA vaccine engineered to
directly address ADE-related vaccine safety concerns. In vivo murine
testing of wild-type and cross-reactivity-reduced vaccines demonstrated
that this theoretical vaccine safety concern is real and that the
cross-reactivity reduced DNA vaccine dramatically reduces dengue
vaccination safety risk while increasing protective antibody responses.
Properly developed and implemented, this novel vaccination strategy
should help overcome this previously-unaddressed hindrance to dengue
vaccine development.
Potential Commercial Applications:
Creation of a safe, efficacious and well-balanced dengue virus
vaccine
Improving currently developed/developing dengue vaccines to
mitigate potential antibody-dependent enhancement safety issues
Research tools for vaccine development programs for other
flaviviruses, HIV
Competitive Advantages:
Murine in vivo studies indicating proof-of-principle, safety
and efficacy
Addresses a long-standing ``serotype immunity balancing''
issue for dengue vaccine development
Presently there are no safe, effective commercially available
dengue vaccines
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Gwong-Jen Chang, Wayne Crill, Holly Hughes, Brent Davis
(all of CDC)
Publication:
Crill WD, et al. Sculpting humoral immunity through dengue
vaccination to enhance protective immunity. Front Immunol. 2012 Nov
8;3:334. [PMID 23162552]
Intellectual Property: HHS Reference No. E-289-2013/0-
US Application No. 61/549,348 filed 20 Oct 2011
PCT Application No. PCT/US2013/060872 filed 18 Oct 2012
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Dated: March 19, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-06404 Filed 3-24-14; 8:45 am]
BILLING CODE 4140-01-P