[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Notices]
[Pages 48544-48546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19912]


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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.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

Rabbit Antisera to Various Matrix, Matricellular, and Other Secreted 
Proteins

    Description of Technology: The extracellular matrix (ECM) is 
composed of a group of proteins that regulate many cellular functions, 
such as cell shape, adhesion, migration, proliferation, and 
differentiation. Deregulation of ECM protein production or function 
contributes to many pathological conditions, including asthma, chronic 
obstructive pulmonary disease, arthrosclerosis, and cancer. Scientists 
at the NIH have developed antisera against various ECM components such 
as proteoglycan, sialoprotein, collagen, etc. (http://www.nidcr.nih.gov/Research/NIDCRLaboratories/CranioSkeletal/Antisera.htm). These antisera can be used as research tools to study 
the biology of extracellular matrix molecules.
    Potential Commercial Applications: Studying the biology of 
extracellular matrix molecules.
    Development Stage: Early-stage.
    Inventor: Larry Fisher (NIDCR).
    Intellectual Property: HHS Reference No. E-135-2008/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; 
[email protected]
    Collaborative Research Opportunity: The National Institute for 
Dental and Craniofacial Research is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize antibodies for studying the biology 
of extracellular matrix molecules. For collaboration opportunities, 
please contact David Bradley, Ph.D. at [email protected].

mNFHcre Transgenic Mice

    Description of Technology: Knockout mouse is a valuable model to 
study biological functions of target genes. When Cre expressing mice 
are bred with mice containing a loxP-flanked gene, the gene between the 
loxP sites will be deleted in the offsprings. Scientists at the NIH 
have generated mNF-H-cre transgenic mouse lines that express Cre 
recombinase under the control of the promoter of the neurofilament-H 
gene, which is expressed in the late stage of neuronal maturation. The 
transgenic mice express cre in neurons (but not astrocytes) with 
highest expression in

[[Page 48545]]

the cortex and hippocampus. The mNF-H-cre transgenic mouse line can be 
used to generate conditional knockout mice with targeted excision of 
neuron-specific genes during the late stage of mouse development. This 
mouse model will be useful for the study of neuronal functions of 
particular genes.
    Potential Commercial Applications: Generating conditional knockout 
mice for neurobiological, neuro-developmental, or aging studies 
involving neurons of the brain and the spinal cord.
    Competitive Advantages: Transgenic mice express Cre recombinase 
selectively in neurons (but not in astrocytes) in the late stage of 
brain development.
    Development Stage: In vivo data available (animal)
    Inventor: Ashok Kulkarni (NIDCR)

Publications

    1. Hirasawa M,et al. Neuron-specific expression of Cre 
recobinase during the late phase of brain development. Neurosci Res. 
2001 Jun; 40(2):125-32. [PMID 11377750].
    2. Hirasawa M, et al. Perinatal abrogation of Cdk5 expression in 
brain results in neuronal migration defects. Proc Natl Acad Sci USA. 
2004 Apr 20; 101(16):6249-54. [PMID 15067135]

    Intellectual Property: HHS Reference No. E-293-2009/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; 
[email protected]
    Collaborative Research Opportunity: The National Institute for 
Dental and Craniofacial Research is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize knockout mice for neurobiological 
studies. For collaboration opportunities, please contact David Bradley, 
Ph.D. at [email protected].

Novel Vaccine for Prevention and Treatment of Chlamydia Infection

    Description of Technology: The invention provides novel vectors, 
attenuated pathogens, compositions, methods and kits for preventing 
and/or treating chlamydia infections.
    Chlamydia trachomatis is an obligate intracellular human pathogen 
with a unique biphasic developmental growth cycle. It's the etiological 
agent of trachoma, the world's leading cause of preventable blindness 
and the most common cause of bacterial sexually transmitted disease. C. 
trachomatis isolates maintain a highly conserved plasmid and naturally 
occurring plasmidless clinical isolates are rare, implicating its 
importance in chlamydial pathogenesis. Understanding the plasmid's role 
in chlamydial pathogenesis at a molecular level is an important 
objective for the future control of chlamydial infections. The NIAID 
inventor had studied chlamydia strains in both non-human primate and 
murine infectious models providing evidence that plasmids play an 
important role in chlamydial pathogenesis. In addition, the study 
results of macaque model of trachoma supports the use of plasmid-
deficient organisms as novel live-attenuated chlamydial vaccines.
    Potential Commercial Applications: Novel live-attenuated chlamydial 
vaccines.

Competitive Advantages

     Virulence attenuated vectors that can be used as vaccines 
against chlamydia.
     Combination of vector with attenuated pathogenic agent 
improves the stability and replicative capacity of the pathogen.
     Features nucleic acids, attenuated pathogens, 
compositions, methods and kits to treat and prevent chlamydia 
infections.

Development Stage

     In vitro data available.
     In vivo data available (animal).
     In vivo data available (human).
     Prototype.
    Inventor: Harlan D. Caldwell (NIAID).

Publications

    1. Song L, et al. Chlamydia trachomatis plasmid-encoded Pgp4 is 
a transcriptional regulator of virulence associated genes. Infect 
Immun. 2013 Mar;81(3):636-44. [PMID 23319558].
    2. Kari L, et al. A live-attenuated chlamydial vaccine protects 
against trachoma in nonhuman primates. J Exp Med. 2011 Oct 
24;208(11):2217-23. [PMID 21987657].

    Intellectual Property: HHS Reference No. E-133-2012/0--
     US Provisional Application No. 61/753,320 filed 16 Jan 
2013.
     PCT Application No. PCT/US2014/011799 filed 16 Jan 2014, 
which published as WO 2014/113541 on 24 Jul 2014.
    Licensing Contact: Peter Soukas; 301-435-4646; [email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Laboratory of Clinical Infectious 
Diseases, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize chlamydia vaccine. For collaboration opportunities, 
please contact Harlan D. Caldwell, Ph.D. at [email protected].

Anti-CD47 Antibodies for the Treatment of Cancer

    Summary: Researchers at the National Cancer Institute found that 
CD47 enhances renewal of breast cancer stem cells, and antibody 
targeting of CD47 forces these stem cells to differentiate.
    Description of Technology: High expression of CD47, a cell surface 
receptor on several types of cancer cells, has been identified as a 
`don't eat me signal' that inhibits their killing by macrophages, 
cytotoxic T cells, and NK cells. Conversely, the CD47 antibody B6H12 
that blocks SIRP[alpha] binding enhances macrophage-dependent clearance 
of tumors in several mouse models, although others have shown that such 
clearance can be independent of SIRP[alpha] signaling.
    Cancer stems cells (CSCs) are tumorigenic cells that are difficult 
to target with conventional chemotherapies due to their 
undifferentiated state. Stem cells also play an important role in the 
pathogenesis of cancer. CSCs have been reported to express elevated 
CD47 levels, but the role of CD47 in directly regulating cancer stem 
cell function has not been examined.
    Researchers at the National Cancer Institute's Laboratory of 
Pathology found in nonmalignant cells and tissues that the absence of 
CD47 enhances stem cell renewal in vitro and in vivo by increasing 
expression of four stem cell transcription factors (see related 
technologies below). Conversely, cancer stem cells often express high 
levels of CD47, and decreasing CD47 is associated with loss of stem 
cell characteristics. More recently, they discovered methods to force 
differentiation of breast cancer stem cells by targeting the receptor 
CD47. These methods disrupt EGF receptor signaling and up-regulate 
tumor suppressor gene expression in breast cancer stem cells from 
triple negative breast cancers, but have no effect on normal mammary 
epithelial cells.

Potential Commercial Applications

     Treatment for breast cancer and other cancers.
     Antibodies for biomedical research.
    Competitive Advantages: Monoclonal antibodies that directly target 
CD47-expressing cancers.
    Development Stage: Pre-clinical (in vivo).
    Inventors: David D. Roberts and Sukhbir Kaur (NCI).

[[Page 48546]]

Publication

    Kaur S, et al. Role of CD47 in triple negative breast cancer. 
FASEB J. 2015 April;29(1 Supplement); Abstract 890.5. [http://www.fasebj.org/content/29/1_Supplement/890.5]

    Intellectual Property: HHS Reference No. E-263-2014/0--US 
Application No. 62/062,675 filed October 10, 2014.

Related Technologies

     HHS Reference No. E-227-2006/5--US Patent 8,236,313 issued 
August 7, 2012; US Patent 8,557,788 issued October 15, 2013; US Patent 
8,865,672 issued October 21, 2014.
     HHS Reference No. E-153-2008/0--US Patent No. 8,951,527 
issued February 10, 2015.
     HHS Reference No. E-086-2012/1--US Patent Application No. 
61/735,701 filed December 11, 2012.
     HHS Reference No. E-296-2011/0--Application PCT/US2014/
025989 filed March 13, 2014.
    Licensing Contact: Jaime M. Greene; 301-435-5559; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Laboratory of Pathology, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
methods to differentiate cancer stem cells. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

Prevention or Treatment of Viral Infections by Inhibition of the 
Histone Methyltransferases EZH1/2

    Description of Technology: Herpes simplex viral infections, 
including herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), are 
exceptionally common worldwide. These viruses establish lifelong 
persistent infections with cycles of lytic reactivation to produce 
recurrent diseases including oral and genital lesions, herpetic 
keratitis/blindness, congenital-developmental syndromes, and viral 
encephalitis. Infection with HSV-2 increases the rate of human 
immunodeficiency virus (HIV) transmission in coinfected individuals. 
DNA replication inhibitors are typically used to treat herpesvirus 
infections. However, these compounds do not completely suppress 
infection, viral shedding, reactivation from latency, and the 
inflammation that contributes to diseases such as keratitis. An unmet 
need continues to exist for methods of preventing or treating 
herpesviral infections. The application claims methods of preventing or 
treating herpesviral infection of a host, comprising administering to 
the host an effective amount of an inhibitor of the EZH1/2 histone 
methyltransferase activities. The application is not limited to herpes 
simplex virus but rather is applicable to other viral infections as 
well.

Potential Commercial Applications

 HSV therapeutics
 HSV vaccines

Competitive Advantages

 Low-cost production
 Ease of synthesis

Development Stage

 In vitro data available
 In vivo data available (animal)
    Inventors: Thomas M. Kristie and Jesse H. Arbuckle (NIAID)
    Intellectual Property: HHS Reference E-141-2015/0--US Provisional 
Patent Application 62/155,704 filed 01 May 2015

Related Technologies

     HHS Reference E-275-2008/0--US Patent Number 8,916,596 
issued 23 Dec 2014; US Application No. 14/543,321 filed 17 Nov 2014; 
PCT Application No. PCT/US2009/051557 filed 23 Jul 2009
     HHS Reference E-184-2010/0--US Patent Number 8,871,789 
issued 28 Oct 2014; PCT Application No. PCT/US2011/044835 filed 21 Jul 
2011
    Licensing Contact: Peter Soukas; 301-435-4646; [email protected]

    Dated: August 7, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-19912 Filed 8-12-15; 8:45 am]
BILLING CODE 4140-01-P