Notice: Government-Owned Inventions; Availability for Licensing

Federal Register: Volume 76, Number 236 (Thursday, December 8, 2011)
                  Pages 76741-76743

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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. 207 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.

ADDRESSES: 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.

Novel NSAIDs for the Treatment of Human Diseases

    Description of Technology: The invention relates to novel compounds 
which are hybrids between two moieties, i.e. non-steroidal anti-
inflammatory drugs (NSAID) and Nitroxyl (HNO) releasing agents as well 
as Nitroxide (an antioxidant and superoxide scavenger). Such modified 
NSAIDs have shown to be advantageous to conventionally used NSAID, as 
their toxicity is significantly reduced and they can thus be used in 
medical treatment for extended periods of time without severe side 
effects. The adverse side effects (i.e. heart attack, thrombosis and 
severe gut toxicity) presented by conventional NSAIDs are well 
documented and some of them (i.e. Vioxx) were therefore withdrawn from 
the market. The present compounds may alleviate these problems, and may 
render more anti-inflammatory agents suitable for human use. The HNO 
releasing moiety of these novel compounds will expand the medical 
utility of these compounds, as HNO releasing agents possess anticancer 
activity as well as good antioxidant activities, a property that is 
beneficial for a variety of human diseases, including acute and chronic 
inflammation. In summary, the hybrid compounds provided in the 
invention can be useful in treatment of variety of human diseases (i.e. 
inflammatory diseases, heart diseases and cancer) with relatively low 
level of side effects.
    Potential Commercial Applications: The drugs of this invention will 
be useful in treatment of anti-inflammatory diseases, and as 
therapeutic or preventative drugs for cardiovascular diseases, diabetes 
and cancer.
    Competitive Advantages: The hybrid structure of the present drugs 
will render them useful in therapy and prevention of a wide variety of 
disorders, with reduced toxicity.
    Development Stage: In vitro data available.
    Inventors: David A. Wink et al. (NCI).
    Publication: Flores-Santana W et al. Redox-Modified Non-Steroidal 
Anti-Inflammatory Drugs as Potential Anti-Cancer Agents with the SOD 
Mimetic Nitroxide. Br J Pharmacol. 2011 Jun 9; doi: 10.1111/j.1476-
5381.2011.01527.x (Epub ahead of print). [PMID 21658022].
    Intellectual Property: HHS Reference No. E-131-2011/0--U.S. 
Provisional

[[Page 76742]]

Application No. 61/472,770 filed 07 Apr 2011.
    Licensing Contact: Betty Tong, Ph.D.; (301) 594-6565; 
tongb@mail.nih.gov.

Fibroblast Growth Factor Receptor 1 (Fgfr1) Conditional Knock Out Mouse

    Description of Technology: Scientists at NIDDK have developed a 
fibroblast growth factor receptor 1 (Fgfr1) conditional knock out 
mouse. Fgfr1 is a member of the Fgfr family of transmembrane protein 
receptors with intrinsic tyrosine kinase activity. Fgfr1 is important 
in multiple biological processes, including mesoderm induction and 
patterning, cell growth and migration, organ formation and bone growth. 
Fgfr1 is highly expressed in central nervous system tissues and plays a 
critical role in proliferation, migration, and survival of neurons and 
glial cells. Additionally, overexpression of Fgfr1 has been associated 
with mammary gland transformation and may be crucial for the 
development of some cancers. The Fgfr1 conditional knockout mouse can 
be used to study development and biological processes in a variety of 
tissues and can provide information on signaling pathways that interact 
with Fgfr1 to induce genes important for critical cellular events, such 
as proliferation, differentiation, adhesion, movement, survival, and 
transformation.

Potential Commercial Applications

     Basic research tool to investigate intracellular pathways 
dependent on Fgfr1.
     Tool to study skeletal and neural development.
     Model of stress-related environments such as bone 
fractures or tumorigenic induction.

Competitive Advantages

     Unlike Fgfr1 null mice that are embryonic lethal, Fgfr1 
conditional knockout mice are viable and can be used to study the role 
of Fgfr1 in tissue and organ development.
     Mice carrying the Fgfr1 conditional knockout mutation can 
be cross-bred using, for example, Cre-expressing mice to generate 
tissue specific knockouts of Fgfr1 and used for more detailed tissue 
studies of Fgfr1 signaling.
    Development Stage: In vivo data available (animal).
    Inventor: Chu-Xia Deng (NIDDK).
    Publication: Xu X, Qiao W, Li C, Deng CX. Generation of Fgfr1 
conditional knockout mice. Genesis. 2002 Feb;32(2):85-86. [PMID 
11857785].
    Intellectual Property: HHS Reference No. E-071-2011/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Jaime M. Greene; (301) 435-5559; 
greenejaime@mail.nih.gov.

Biomarkers for Cancer-Related Fatigue and Their Use in the Management 
of Such Fatigue (CRF)

    Description of Technology: The invention relates to the diagnosis 
and management of cancer-related fatigue (CRF). More specifically the 
invention relates to identification and measurement of a single 
Biomarker or a group of biomarkers (e.g. genes) that are associated 
with cancer related fatigue. The identification and measurement of such 
biomarkers can be utilized in the diagnosis and management of fatigue 
and may facilitate the development of therapy for such fatigue. In 
particular, the invention provides for a method of diagnosing a subject 
with CRF by detecting expression of at least one gene associated with 
CRF in a sample obtained from the subject; and comparing expression of 
the gene to a control. The invention also describes a method of 
treating a patient with CRF by administering to the subject an agent 
that alters expression or activity of a gene associated with CRF. 
Further provided in the invention is array that includes a plurality of 
genes associated with CRF, such as TNFRSF25, SLC6A8, OGT, SNCA, APBA2, 
CASK, OR2W3, MYL4, IL7R, ARHGEF10 and ITGA6. Some of these genes are 
over expressed in a CRF patient (e.g., SNCA and SLC6A8) while others 
(e.g., IL7R, ARHGEF10) are under expressed. The array can provide 
detailed and comprehensive information that can result in improved 
diagnostics and in increased options for therapeutic treatment.
    Potential Commercial Applications: Diagnostics and therapeutics of 
cancer-related fatigue.
    Competitive Advantages: The technology provides for an array of 
multiple biomarkers, all associated with CRF. Thus it may offer a more 
detailed and accurate diagnosis of CRF as well as a larger number of 
therapeutic options.

Development Stage

     In vitro data available (animal).
     In vivo data available (human).
    Inventor: Leorey Saligan (NINR).
    Intellectual Property: HHS Reference E-280-2010/0 -- U.S. 
Provisional Application No. 61/442,605 filed 14 Feb 2011.
    Licensing Contact: Betty Tong, Ph.D.; (301) 594-6565; 
tongb@mail.nih.gov.

Characterizing Compartment Distributions From Diffusion Weighted 
Magnetic Resonance (MR) Data

    Description of Technology: The National Institutes of Health seeks 
licensees with MR software expertise to commercialize a method of 
imaging the structural and dimensional characteristics (microstructure) 
of microscopic specimens. Microstructure is elucidated using MR 
scanning and the diffusion weighted MR signal is transformed into 
statistical moments of the underlying compartment size distribution 
associated with restricted diffusion. Essentially, the method includes 
the steps of: (1) Acquiring diffusion weighted image or spectroscopic 
data, (2) applying the new modeling framework relating pore size 
distribution to the diffusion weighted (DW) data, and (3) using this 
framework to estimate moments of the pore diameter distribution from 
the DW data.
    Potential Commercial Applications: Examination of tissue/cellular 
microstructures.
    Competitive Advantages: Refined imaging.
    Development Stage: In vitro data available.
    Inventors: Evren Ozarslan and Peter J. Basser (NICHD).

Publications

    1. Assaf Y, et al. AxCaliber: a method for measuring axon 
diameter distribution from diffusion MRI. Magn Reson Med. 2008 
Jun;59(6):1347-1354. [PMID 18506799].
    2. Shemesh N, et al. Accurate noninvasive measurement of cell 
size and compartment shape anisotropy in yeast cells using double-
pulsed field gradient MR. NMR Biomed. 2011 July 22. E-pub ahead of 
print, doi: 10.1002/nbm.1737. [PMID 21786354].
    3. Ozarslan E, et al. NMR characterization of general 
compartment size distributions. New J Phys. 2011 Jan;13:15010. [PMID 
21709780].
    4. Komlosh ME, et al. Pore diameter mapping using double pulsed-
field gradient MRI and its validation using a novel glass capillary 
array phantom. J Magn Reson. 2011 Jan;208(1):128-135. [PMID 
21084204].
    5. Nevo U, et al. A system and mathematical framework to model 
shear flow effects in biomedical DW-imaging and spectroscopy. NMR 
Biomed. 2010 Aug;23(7):734-744. [PMID 20886564].
    6. Shemesh N, et al. From single-pulsed field gradient to 
double-pulsed field gradient MR: gleaning new microstructural 
information and developing new forms of contrast in MRI. NMR Biomed. 
2010 Aug;23(7):757-780. [PMID 20690130].
    7. Shemesh N, et al. Noninvasive bipolar double-pulsed-field-
gradient NMR reveals signatures for pore size and shape in 
polydisperse, randomly oriented, inhomogeneous porous media. J Chem 
Phys. 2010 Jul 28;133(4):044705. [PMID 20687674].


[[Page 76743]]


    Intellectual Property: HHS Reference No. E-273-2010/0--U.S. 
Provisional Patent Application No. 61/522,421 filed 11 Aug 2011.

Related Technologies

     HHS Reference No. E-079-2003/0--U.S. Patent 7,643,863 
issued 05 Jan 2010; International Patent Application PCT/US2004/22027 
filed 08 Jul 2004, which published as WO 2005/012926 on 10 Feb 2005.
     HHS Reference No. E-079-2003/1--U.S. Patent Application 
12/114,713 filed 02 May 2008.
    Licensing Contact: Michael Shmilovich, Esq.; (301) 435-5019; 
mish@codon.nih.gov.

One Step Fluorine-18 Peptide Labeling Strategy of Biological Substrates

    Description of Technology: A one-step process is now available for 
licensing that allows direct 18F labeling of any biological substrate 
that is modified with 4-nitro-3-trifluoromethyl arene. Normally, 18F 
labeling requires several time-consuming radio synthesis steps using 
prosthetic groups, resulting in a low labeling yield. Other attempts at 
one step labeling methods have also shown relatively low yields.
    This new process eliminates time-consuming radiosynthesis steps and 
associated low labeling yields with a single step process that 
displaces a nitro group in an arene. Relatively low amounts of 
precursor and short time radiosynthesis times are required compared to 
direct peptide-labeling. Higher yields by this simplified process 
improve time and cost efficiencies and may make 18F labeling more 
amenable for automation.

Potential Commercial Applications

     Radiological imaging.
     Radiological diagnosis.
     Radiological therapy.

Competitive Advantages

     Significantly shorter reaction and synthesis times.
     Lower amounts of precursor required.
     Relatively high yield of specific activity product.

Development Stage

     Early-stage.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Xiaoyuan (Shawn) Chen and Orit J. Weiss (NIBIB).
    Publication: Jacobson O, et al. Rapid and simple one-step F-18 
labeling of peptides. Bioconjug Chem. 2011 Mar 16;22(3):422-428. [PMID 
21338096].
    Intellectual Property: HHS Reference No. E-238-2010/0--U.S. 
Provisional Patent Application No. 61/429,671 filed 04 Jan 2011.
    Licensing Contact: Tedd Fenn; (301) 435-5031; Tedd.Fenn@NIH.gov.
    Collaborative Research Opportunity: The NIBIB is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize the technology 
for One Step Fluorine-18 Peptide Labeling Strategy of Biological 
Substrates. For collaboration opportunities, please contact Shawn Chen, 
Ph.D. at shawn.chen@nih.gov.

    Dated: December 2, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-31553 Filed 12-7-11; 8:45 am]
BILLING CODE 4140-01-P