[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20667-20669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07917]


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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. 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.

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.

Highly Potent and Selective Deubiquitinating Enzyme Inhibitor

    Description of Technology: Available for licensing are inhibitors 
that target the USP1/UAF1 deubiquitnating enzyme (DUB) complex. The FDA 
approval and commercial success of

[[Page 20668]]

Velcade[supreg], a small molecule proteasome inhibitor, has established 
the ubiquitin-proteasome system (UPS) as a valid target for anticancer 
treatment. However, proteasome inhibitors in general suffer from a 
narrow therapeutic index and acquired resistance. A promising 
alternative to proteasome inhibition has been to target the enzymes 
upstream of proteasome-mediated protein degradation, i.e. the ubiquitin 
conjugation and deconjugation, to generate more specific, less toxic 
therapeutic agents. The investigators have developed small molecules 
that target the USP1/UAF1 DUB complex that acts upstream of UPS and has 
been implicated in the DNA damage response. These compounds are the 
most potent and selective DUB inhibitors reported to date. Moreover, 
the inhibitors act synergistically with cisplatin, a DNA damaging anti-
cancer drug, to overcome chemoresistance and enhance cytotoxicity. 
These results suggest the inhibitors may also improve the efficacy and 
potency of other commonly prescribed chemotherapeutic agents that are 
known to induce DNA damage.
    Potential Commercial Applications:
     Method to treat cancer
     Method to overcome chemoresistance to cisplatin
     Pharmaceutical compositions
    Competitive Advantages:
     Represents the most potent and selective DUB inhibitor 
reported to date.
     Promising alternative to proteasome inhibition offering 
the potential of more selective and less toxic therapeutic agents.
     Acts synergistically with DNA damaging agents to overcome 
chemoresistance.
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: David Maloney (NCATS), Andrew Rosenthal (NCATS), Ajit 
Jadhav (NCATS), Thomas Dexheimer (NCATS), Anton Simeonov (NCATS), 
Zhihao Zhuang (University of Delaware), Qin Liang (University of 
Delaware), Diane Luci (NCATS)
    Intellectual Property: HHS Reference No. E-043-2013/0--US 
Provisional Application No. 61/747,052 filed 28 December 2012
    Related Technologies:
     HHS Reference No. E-208-2007/0--US Patent Application No. 
12/669,361 filed 15 January 2010
     HHS Reference No. E-156-2012/0--US Provisional Application 
No. 61/692,560 filed 23 August 2012
     HHS Reference No. E-231-2002/0--US Patent No. 7,498,336 
issued 3 March 2009
     HHS Reference No. E-070-2005/0--US Patent No. 8,242,160 
issued 14 June 2012 and US Patent Application No. 13/547,417 filed 12 
July 2012
    Licensing Contact: Jennifer Wong, M.S.; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Center for 
Advancing Translational Sciences 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 Lili Portilla at [email protected].

Therapeutic Applications of a Carboxy-Terminal RTDL Motif

    Description of Technology: Mesencephalic Astrocyte-derived 
Neurotrophic Factor (MANF) is a secreted neurotrophic factor with known 
anti-neurodegenerative properties. The inventors discovered that the C-
terminal RTDL motif of MANF is involved in the anti-degenerative 
properties of MANF and association of extracellular MANF with the cell 
surface. Isolated peptides, including the C-terminal RTDL motif of 
MANF, potentially can be used as a treatment for neurodegenerative 
disorders and ischemia.
    Potential Commercial Applications: Treating neurodegenerative 
diseases, such as Alzheimer's disease, Parkinson's disease, Huntington 
disease, etc.
    Competitive Advantages: Secreted novel peptides.
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
    Inventors: Brandon K Harvey, et al. (NIDA)
    Intellectual Property: HHS Reference No. E-249-2012/0--US 
Provisional Application 61/732, 241 filed 30 Nov 2012
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected]

HIV-Neutralizing Polypeptides: A Novel Use for Platelet Factor 4 or Its 
Derivatives

    Description of Technology: The subject invention describes the 
method for using Platelet Factor 4 (PF4), also called CXCL4, to inhibit 
HIV viral entry by blocking GP120 independent of HIV receptor. It also 
demonstrates that the active polypeptide fragment(s) of PF-4 could be 
used to identify potential peptide mimics or small molecules that could 
be used to inhibit HIV infection. PF4 and/or its derivatives may be 
developed as a systemic therapy or preventive measure using topical 
applications, such as microbicides. In addition, CXCL4 serum/plasma 
testing could be used as a clinical marker of HIV disease status to 
predict/monitor the efficacy of treatment and determine the prognosis 
of a subject with HIV infection.
    Potential Commercial Applications:
     Treatment and prevention of HIV-1 infection.
     Topical application as microbicides.
     A vaccine adjuvant to boost the vaccine efficacy.
     A clinical marker of HIV disease status or to predict/
monitor the efficacy of treatment or vaccines.
    Competitive Advantages:
     A new HIV-1 inhibitory molecule that acts through a new 
inhibitory mechanism.
     Any potential derivative or mimicking compound would be 
unique and have the advantage of hitting a previously unrecognized 
molecular target in the HIV life cycle.
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Paolo Lusso and David J. Auerbach (NIAID)
    Publication: Auerbach DJ, et al. Identification of the platelet-
derived chemokine CXCL4/PF-4 as a broad-spectrum HIV-1 inhibitor. Proc 
Natl Acad Sci USA 2012 Jun 12;109(24):9569-74. [PMID 22645343]
    Intellectual Property: HHS Reference No. E-140-2012/0--US 
Application No. 61/649,150 filed 19 Jun 2012
    Related Technology: The CXCL4 sequence is in the public domain.
    Licensing Contact: Sally Hu, Ph.D., MBA; 301-435-5606; 
[email protected].

Polarimetric Accessory for Colposcope

    Description of Technology: Available for licensing and commercial 
development is a colposcope accessory device that compensates and 
resolves tissue borne specular reflections. In medical diagnostic 
procedures for examining the cervix and the tissues of the vagina and 
vulva, long working-distance (-30 cm) lighted binocular microscope 
(colposcope) that provide up to 25x optical magnification are used to 
create an illuminated magnified view. Speculum dilations can give rise 
to specular reflections from the tissue surface. The present 
polarimetric accessory overcomes this limitation and enhances the 
visibility of subsurface structures of the scattering object. Linearly 
polarized light is used for cervical illumination and imaging is

[[Page 20669]]

performed through an additional polarizer that separates the specularly 
reflected light from the diffusely backscattered light, which 
originates in deeper tissue layers, allowing enhanced imaging of the 
hidden subsurface tissue structure (texture). The region of interest is 
illuminated by linearly polarized light, and backscattered light passes 
through the polarization filter to be detected by a digital camera. A 
custom optical design preserves the polarization state of the 
backscattered light in the microscope, without interfering with the 
standard optical path and operation of the microscope, including its 
binocular system. Special algorithms to visualize regions of 
statistical similarity in the image have been developed. Though the 
diffusely backscattered light presents only a small fraction of the 
detected light, its analysis, using the customized design and image 
processing procedures, provides useful information about internal 
structures of biological tissues. The polarimetric accessory includes a 
linear polarizer for the illuminating beam, two beam splitters for 
preserving polarization state, lens system for imaging, polarization 
analyzer, band-pass optical filter, digital camera, and electronic 
triggering system.
    Potential Commercial Applications: Gynecological examinations
    Competitive Advantages:
     Image quality
     Resolution of tissue structures at close microscopic 
distances
    Development Stage: Prototype
    Inventors: Amir Gandjbakhche (NICHD), Victor Chernomordik (NICHD), 
Moinuddin Hassan (NICHD), Alexander Sviridov (NICHD), Zachary Alissi 
(NICHD), Paul Smith (NIBIB), Albert Boccara (NICHD)
    Publications:
    1. Jacques SL, et al. Imaging superficial tissues with polarized 
light. Lasers Surg Med. 2000;26(2):119-29. [PMID 10685085]
    2. Jacques SL, et al. Imaging skin pathology with polarized light. 
J Biomed Opt. 2002 Jul;7(3):329-40. [PMID 12175282]
    3. Ramella-Roman JC, et al. Design, testing, and clinical studies 
of a handheld polarized light camera. J Biomed Opt. 2004 Nov-
Dec;9(6):1305-10. [PMID 15568952]
    4. Sviridov AP, et al. ``Analysis of Biological Tissue Textures 
Using Measurements of Backscattered Polarized Light'' (presented at the 
Optical Society of America--Biomedical Optics Topical Meeting, Fort 
Lauderdale, Florida, March 2006).
    5. Sviridov AP, et al. Visualization of biological texture using 
correlation coefficient images. J Biomed Opt. 2006 Nov-
Dec;11(6):060504. [PMID 17212522]
    Intellectual Property: HHS Reference No. E-084-2012--US Provisional 
Patent Application No. 61/620,295 filed 04 Apr 2012
    Licensing Contact: Michael A. Shmilovich, Esq., CLP; 301-435-5019; 
[email protected]

CpG Oligonucleotides Treatment To Prevent Chemotherapy-Induced 
Pulmonary Toxicity

    Description of Technology: Bleomycin (BLM) is a chemotherapy agent 
used to treat multiple types of cancer, but its side effects are life 
threatening for some patients. About 20% of patients undergoing BLM 
chemotherapy develop interstitial pneumonitis which may develop to life 
threatening fibrosis. In such cases, BLM chemotherapy cannot be 
continued.
    This invention identifies a method of pre-treatment using 
immunostimulatory CpG Oligonucleotide (ODN) molecules to prevent 
chemotherapy-induced pulmonary toxicity. Administration of certain ODN 
molecules induces inflammation via stimulation of inflammatory genes 
(Toll-like receptor 9/TLR9). This stimulation is subsequently down-
regulated. This technology makes use of this counter regulatory 
mechanism to reduce the side effects of chemotherapy agents, such as 
BML. A properly timed pre-administration of ODN molecules, prior to BML 
therapy, prevents the lethal side effect of BLM-induced pulmonary 
inflammation and down-regulates promoters of BLM toxicity (IL-17A and 
TGF-beta1). Because toxicity from pulmonary inflammation is a side 
effect limiting use of many chemotherapeutic agents and ODN molecules 
are relatively inexpensive and have a favorable safety profile, this 
technology may be useful to improve treatment protocols for many 
chemotherapy agents.
    Potential Commercial Applications: Therapeutic to reduce harmful 
side effects of pulmonary inflammation caused by chemotherapy.
    Competitive Advantages:
     Pulmonary toxicity during chemotherapy is dangerous side 
effect, this technology uses ODN molecules that are relatively 
inexpensive and have a favorable safety profile to reduce this side 
effect.
     This technology may increase the safety and availability 
of many chemotherapy treatments.
    Development Stage:
     Early-stage
     In vivo data available (animal)
    Inventors: Dennis Klinman and Takeshi Kinjo (NCI)
    Publication: Kinjo T, et al. The counter regulatory response 
induced by CpG oligonucleotides prevents bleomycin induced pneumopathy. 
Respir Res. 2012 Jun 18;13:47. [PMID 22708497]
    Intellectual Property: HHS Reference No. E-077-2012/0--U.S. 
Provisional Patent Application No. 61/643,088 filed 04 May 2012
    Licensing Contact: Edward (Tedd) Fenn; 301-435-5031; 
[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 
CpG oligonucleotides for use to down-modulate inflammatory reactions. 
For collaboration opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

    Dated: April 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-07917 Filed 4-4-13; 8:45 am]
BILLING CODE 4140-01-P