[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

[[Page 16349]]

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