[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48692-48695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19285]


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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.

Rabbit Antibody to Mouse Sphingosine-1-phosphate (S1P) Lyase

    Description of Technology: The cleavage of sphingoid base 
phosphates by sphingosine-1-phosphate (S1P) lyase to produce 
phosphoethanolamine and a fatty aldehyde is the final degradative step 
in the sphingolipid metabolic pathway. Researchers at NIH injected 
rabbits with the C-terminal peptide of the mouse S1P lyase--551-
TTDPVTQGNQMNGSPKPR-568--to develop an antibody that can be used in 
western blotting to study this pathway.
    Potential Commercial Applications: The antibody can be used to 
detect and measure S1P lyase.
    Competitive Advantages: The antibody works very well for western 
blotting.
    Development Stage: In vitro data available.
    Inventor: Richard L. Proia (NIDDK).
    Publication: Bektas M, et al. Sphingosine 1-phosphate lyase 
deficiency disrupts lipid homeostasis in liver. J Biol Chem. 2010 Apr 
2;285(14):10880-9. [PMID 20097939].
    Intellectual Property: HHS Reference No. E-465-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.

[[Page 48693]]

    Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559; 
[email protected].

Rabbit Antibody to Mouse Sphingosine Kinase 2 (SphK2)

    Description of Technology: Two isoforms of sphingosine kinase, 
sphingosine kinase 1 (SphK1) and sphingosine kinase 2 (SphK2), convert 
sphingosine to sphingosine 1-phosphate (S1P) in mammalian cells. While 
the importance of SphK1 has been known for some time, information about 
SphK2 is still being revealed. Therefore, researchers at NIH have 
developed an antibody against mouse SphK2, which can be used to further 
understand the role of this enzyme.
    Potential Commercial Applications: The antibody can be used to 
detect and measure SphK2.
    Competitive Advantages: The antibody works very well for western 
blotting.
    Development Stage: In vitro data available.
    Inventor: Richard L. Proia (NIDDK).
    Publication: Olivera A, et al. IgE-dependent activation of 
sphingosine kinases 1 and 2 and secretion of sphingosine 1-phosphate 
requires Fyn kinase and contributes to mast cell responses. J Biol 
Chem. 2006 Feb 3;281(5):2515-25. [PMID 16316995].
    Intellectual Property: HHS Reference No. E-466-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559; 
[email protected].

Video Monitoring System for Vivarium Cage Racks

    Description of Technology: This invention pertains to a system for 
continuous observation of rodents in home-cage environments with the 
specific aim to facilitate the quantification of activity levels and 
behavioral patterns for mice housed in a commercial ventilated cage 
rack. The home-cage in-rack provides daytime and nighttime monitoring 
with the stability and consistency of a home-cage environment. The 
system is made up of a dual-video camera hardware design mounted on a 
video rack and an executable software means for automatic detection and 
processing for tracking multiple animals.
    Potential Commercial Applications:
     vivarium monitoring.
     laboratory test animal management.
    Competitive Advantages:
     real-time monitoring.
     day or night monitoring.
    Development Stage: Prototype.
    Inventors: James Mitchell (NCI), Ghadi Salem (CIT), Thomas Pohida 
(CIT).
    Intellectual Property: HHS Reference No. E-090-2013/0--US 
Provisional Patent Application 61/841,064 filed June 28, 2013.
    Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
Video Monitoring System for Vivarium Cage Racks. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

MRI Scanner Bore Covering

    Description of Technology: This invention pertains to a bore 
covering for creating controlled environments and specifically for 
maintaining temperature within the bore of an MRI scanner. The bore 
covering includes a covering sheet with fastening means (e.g., weak-
tack adhesive, pressure-sensitive adhesive or low-tack adhesive) around 
its inner surfaces that permits reversible attachment to the scanner. 
The adhesive ends can be peeled away to expose an edge of the bore 
opening or the entire sheet may be constructed with peel away gaps so 
that warm air can be pumped into the bore. On the inner surface the 
bore covering may include a gap that is connected to a climate control 
device or an exhaust vent to expel air out of the MRI scanner bore.
    Potential Commercial Applications: MR imaging of infants and 
neonates.
    Competitive Advantages:
     Temperature control.
     Comfort.
    Development Stage: Prototype.
    Inventors: Robert Balaban, Robert Lederman, Michael Hansen, Anthony 
Faranesh, Kanishka Ratnayaka (all of NHLBI).
    Intellectual Property: HHS Reference No. E-026-2013/0--US 
Provisional Patent Application 61/836,817 filed June 19, 2013.
    Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute (NHLBI) is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize MRI Scanner Bore Covering. For collaboration 
opportunities, please contact Dr. Denise Crooks at 
[email protected].

Cotranslational Protein Expression System for High-throughput Screening

    Description of Technology: Reporter gene-based assays are used 
extensively in high-throughput screening (HTS) to identify chemical 
modulators of cellular pathways for drug discovery and development. 
However, such screening frequently results in a large number of false 
``hits'' due to interactions of screened compounds with reporter 
proteins, producing confounding results. Thus, validation of results 
using these assays often involves significant time and expense.
    The inventors have developed an assay system that significantly 
improves detection of target-relevant active compounds by 
discriminating between signals arising from the target activity and 
those caused by reporter bias. This system utilizes simultaneous 
detection (also known as ``coincidence detection'') of non-homologous 
reporter proteins with dissimilar properties, such as differing 
catalysis, light emission, or fluorescence characteristics; 
simultaneous observation of signals from these reporters indicates a 
high probability that it is a true target response. The reporters are 
cotranslationally expressed from a single RNA transcript, which ensures 
stable stoichiometry of the expressed proteins.
    Potential Commercial Applications: High-throughput screening of 
chemical libraries in a single assay platform for commercial or 
research use.
    Competitive Advantages: This method will significantly enhance the 
ability to identify and prioritize active compounds from reporter gene-
based assays.
    Development Stage: Early-stage.
    Inventors: James Inglese, Ken C-C Cheng, Samuel A. Hasson (all of 
NCATS).
    Publication: Chan K, Inglese J. A coincidence reporter-gene system 
for high-throughput screening. Nat Methods. 2012 Oct;9(10):937. [PMID 
23018994].
    Intellectual Property: HHS Reference No. E-300-2012/0--PCT 
Application No. PCT/US2013/032184 filed March 15, 2013.
    Licensing Contact: Tara L. Kirby, Ph.D.; 301-435-4426; 
[email protected].
    Collaborative Research Opportunity: The National Center for 
Advancing Translational Sciences (NCATS) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize Cotranslational 
Protein Expression

[[Page 48694]]

System for High-throughput Screening. For collaboration opportunities, 
please contact NCATS Technology Development Coordinator at 
[email protected].

Human Melanoma Metastasis Cell Lines Harboring Bcl-2-Like Protein 12 
(BCL2L12) Mutations

    Description of Technology: Using whole-genome and whole-exome 
sequencing to identify somatic (e.g., tumor-specific) alternations in 
human melanoma samples, the researchers at the NIH have found a 
recurrent synonymous (or silent) somatic mutation in the Bcl-2-Like 
Protein 12 (BCL2L12). The mutant BCL2L12 bound to p53 and inhibited UV-
induced apoptosis more efficiently than wild-type BCL2L12 and therefore 
could be a novel melanoma oncoprotein. This appears to be the first 
report of a mutation that does not alter the encoded protein, yet 
affects the protein function in the cancer genome. Consequently, these 
cell lines could be used to further investigate the effects of BCL2L12 
in melanoma and to develop therapeutics targeting this gene and 
protein.
    Potential Commercial Applications:
     Diagnostic array for the detection of BCL2L12 mutations.
     In vitro and in vivo cell model for the BCL2L12 mutation 
in melanoma. This is a useful tool for investigating BCL2L12 phenotype 
biology, including growth, motility, invasion, and metabolite 
production.
    Competitive Advantages:
     Cell lines are derived from melanoma patients.
     The BCL2L12 mutation is frequent in melanomas.
    Development Stage: Pre-clinical.
    Inventors: Yardena Samuels (NHGRI) and Steven Rosenberg (NCI).
    Publication: Gartner JJ, et al. Whole-genome sequencing identifies 
a recurrent functional synonymous mutation in melanoma. Proc Natl Acad 
Sci USA. 2013 Jul 30; Epub ahead of print. [PMID 23901115].
    Intellectual Property: HHS Reference No. E-145-2012/0--Research 
Tool. Patent protection is not being pursued for the BCL2L12 melanoma 
metastatic cell lines.
    Related Technologies: HHS Reference Nos. E-029-2012/0 (research 
tool), E-013-2011/0 (patent app: US), E-024-2012/0 (research tool), E-
272-2008/0 (patent app: US, EP), E-229-2010/0 (research tool), E-232-
2010/0 (research tool).
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The NHGRI 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 Claire Driscoll, 
Director, NHGRI Technology Transfer Office, at [email protected] or 
301-594-2235.

Gag-Based DNA Vaccines Against HIV

    Description of Technology: Novel DNA vaccine constructs against HIV 
that express highly conserved elements (CE) within the HIV Gag protein 
and elicit strong, cross-clade cellular and humoral responses. The DNA 
vaccine vectors were engineered to express CEs for protection against 
different clades of HIV and prevention of immunodominance, two issues 
associated with current HIV vaccine candidates.
    In vivo studies of Rhesus macaques vaccinated with variants of 
these constructs expressing seven highly CEs covering >99 of all known 
Gag sequences elicited strong, cellular T-cell and humoral antibody 
immune responses. The Gag-specific antibody responses were high titer 
and cross-clade. Cross-clade protection is important given the sequence 
diversity of HIV as is the absence of immunodominant epitopes that 
generate antibodies which are not protective against HIV.
    Potential Commercial Applications: HIV vaccines.
    Competitive Advantages: Addresses two key hurdles faced by current 
HIV vaccines: sequence diversity of HIV and immunodominance.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: George N. Pavlakis (NCI), Barbara K. Felber (NCI), James 
Mullins (University of Washington).
    Intellectual Property: HHS Reference No. E-132-2012/0--PCT 
Application No. PCT/US2013/028932 filed March 4, 2013.
    Related Technology: HHS Reference No. E-308-2000/0--Patent family 
filed in the U.S., Canada, Australia, Europe, and Japan.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected].

Diffusion Through Skull as Route of Delivery for Treatment of Brain 
Injury and Disease

    Description of Technology: Traumatic Brain injury (TBI) often 
results from head impact and is a major cause of death and disability. 
Brain injuries vary in severity and can be associated with 
hemorrhaging, swelling, inflammation, and death of brain tissue. 
Inventors at NINDS developed a novel approach to treating brain 
injuries that involves transcranial application of small molecules. 
They discovered, using two photon laser scanning microscopy, that 
compounds as large as 40,000 molecular weight (MW) can pass directly 
through the intact skull into the underlying cerebral spinal fluid 
(CSF) that circulates through the brain and spinal cord. Small 
molecular weight compounds (e.g. 600 MW) pass through the skull more 
quickly than large ones and appear to do so by simple diffusion. 
Researchers have shown that application of a variety of agents, 
including glutathione, TNP-ATP hydrase (P2X4 inhibitor), oxidated ATP 
(P2X7 inhibitor), MRS2578 (P2Y6 inhibitor), MeSAMP (P2Y12 inhibitor) 
and Carbenoxelone (Connexin Hemichannel Inhibitor) directly to the head 
results in delivery of the agents to the brain. Transcranial drug 
application can be used to pharmacologically target several tiers of 
brain injury responses, from the toxic mediators that cause cell death 
to the molecular signals that drive inflammation. Application can be by 
direct application to the skull through the scalp (e.g. rubbing it in), 
transdermal patch, or subcutaneous injection under the scalp.
    Potential Commercial Applications:
     Treating Traumatic Brain Injury.
     Treating stroke.
     Treating other acute CNS conditions, including 
encephalitis and meningitis.
     Treating chronic CNS disorders such as brain tumors, 
Alzheimer's, Parkinson's, and multiple sclerosis.
    Competitive Advantages:
     Quickly achieves a high local drug concentration at the 
site of brain injury.
     Bypasses the blood brain barrier and allows rapid 
administration of therapeutic agents directly into injured or inflamed 
brain.
     Current therapies to treat Traumatic Brain Injury with 
neuroprotective agents are often limited by ability to achieve 
therapeutic concentrations of therapeutic agent in the brain.
    Development Stage:
     In vitro data available.
     In vivo data available (animal).
    Inventors: Dorian McGavern and Theodore Roth (NINDS).
    Publication: Manuscript in preparation.
    Intellectual Property: HHS Reference No. E-025-2012/0--PCT 
Application No. PCT/US2013/24741 filed February 5, 2013.

[[Page 48695]]

    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Neurological Disorders and Stroke (NINDS) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize treatment of 
brain injury or disease through transcranial drug delivery. For 
collaboration opportunities, please contact Melissa Maderia, Ph.D., 
M.B.A. at [email protected] or 240-276-5533.

Tri-functional Imaging Agent for Monoclonal Antibody Tumor-Targeted 
Imaging

    Description of Technology: This is a novel lysine-based 
trifunctional chelate which bears both a chelating moiety (CHX-A'') for 
sequestering radiometals (86Y or 111In) and a near-infrared dye, e.g., 
Cy5.5, for dual modality PET (or SPECT) and fluorescence imaging. 
Successful conjugation of monoclonal antibody trastuzumab (Herceptin) 
or cetuximab (Erbitux), has also been achieved by efficient thiol-
maleimide chemistry, thereby yielding an immunoconjugate (Signaling 
agent (Cy5.5-Lys(SMCC)-CHX-A'') conjugated to trastuzumab) or 
(Signaling agent (Cy7-Lys(SMCC)-CHX-A'') conjugated to cetuximab). Both 
specifically target antigen expressing cells and internalization of the 
agent has been imaged over time. Trastuzumab can be radiolabeled with 
isothiocyanate derivatives of the bifunctional chelating agents 1B4M 
(2-(4-aminobenzy1)-6-methyldiethylenetriaminepentaacetic acid); and 
CHX-A'' (N-[(R)-2-amino-3-(p-aminophenyl)propyl]-trans-(S,S)-
cyclohexane-1,2-diamine-N,N,N',N'',N''-pentaacetic acid).
    Potential Commercial Applications:
     Cancer imaging.
     Cancer diagnostics.
    Competitive Advantages:
     Target specific.
     Multifunctional (imageable through multiple platforms).
    Development Stage:
     Early-stage.
     In vivo data available (animal).
    Inventors: Martin W. Brechbiel, Heng Wu, Kwamena E. Baidoo (all of 
NCI).
    Publications:
    1. Xu H, et al. Design, synthesis, and characterization of a dual 
modality positron emission tomography and fluorescence imaging agent 
for monoclonal antibody tumor-targeted imaging. J Med Chem. 2007 Sep 
20;50(19):4759-65. [PMID 17725340]
    2. Nayak TK, et al. PET and MRI of metastatic peritoneal and 
pulmonary colorectal cancer in mice with human epidermal growth factor 
receptor 1-targeted 89Zr-labeled panitumumab. J Nucl Med. 2012 
Jan;53(1):113-20. [PMID 22213822]
    3. Dadwal M, et al. Synthesis and evaluation of a bifunctional 
chelate for development of Bi(III)-labeled radioimmunoconjugates. 
Bioorg Med Chem Lett. 2011 Dec 15;21(24):7513-5. [PMID 22047687]
    4. Song HA, et al. Efficient bifunctional decadentate ligand 3p-C-
DEPA for targeted alpha-radioimmunotherapy applications. Bioconjug 
Chem. 2011 Jun 15;22(6):1128-35. [PMID 21604692]
    5. Bumb A, et al. Preparation and characterization of a magnetic 
and optical dual-modality molecular probe. Nanotechnology. 2010 Apr 
30;21(17):175704. [PMID 20368682]
    Intellectual Property: HHS Reference No. E-194-2007/0--US Patent 
Application No. 12/667,790 filed 05 Jan 2010 (allowed).
    Related Technology: HHS Reference No. E-111-2013/0--US Provisional 
Application No. 61/779,016 filed 13 Mar 2013.
    Licensing Contact: Michael A. Shmilovich, Esq., CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Radiation Oncology Branch is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize Trifunctional Imaging Agent for 
Monoclonal Antibody Tumor-Targeted Imaging. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

     Dated: August 6, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-19285 Filed 8-8-13; 8:45 am]
BILLING CODE 4140-01-P