[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21636-21638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9642]


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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, Public Health Service, 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

[[Page 21637]]

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.

Thermostable Y-Family Polymerases From Fungi for Use in Forensic DNA 
Services and Analysis of Damaged or Ancient DNA

    Description of Invention: Y-family polymerases are able to bypass 
lesions in DNA that would otherwise block replication by high fidelity 
DNA polymerases and are key to the effective study of ancient DNA and 
for use in forensic medicine. These enzymes are ubiquitous and are 
found in all kingdoms of life: Bacteria, archaea and eukaryotes. The 
number of proteins related to the Y-family polymerases is well over 200 
orthologs and despite being closely related at the phylogenetic level, 
the few polymerases now characterized, each show a unique set of 
properties including processivity, fidelity, and the ability to bypass 
certain types of DNA. Y-family polymerases from thermostable organisms 
are of particular interest because the enzymes isolated from such 
species tend to be more stable, easy to work with and may have more 
utility in assays at higher temperatures, such as Polymerase Chain 
Reaction (PCR). For example, the thermostable archeal Sulfolobus 
solfataricus DinB-like polymerase Dpo4 can bypass lesions by generally 
inserting the correct complementary nucleotide opposite a variety of 
damaged bases and can, under appropriate conditions substitute for Taq 
polymerase in PCR applications [Nucleic Acids Res. 2001 Nov 
15;29(22):4607-4616; HHS Ref. No. E-232-2001/0]. Additionally, 
functional and structural organization of this family of polymerases 
permits domain swapping designed to optimize specific properties of use 
in novel applications [J Biol Chem. 2004 Jul 30;279(31):32932-32940].
    Dr. Woodgate's group at the National Institute of Child Health and 
Development have expanded their earlier work (HHS Ref. Nos. E-166-2004/
0,/1, &/2) and have now cloned and expressed full length Y-family 
polymerases Thermoascus auranticus Pol eta, Thermomyces lanuginosus Pol 
eta, Thermomyces lanuginosus Pol iota, Thermomyces lanuginosus Pol 
kappa, Thermomyces lanuginosus REV1, Sporotrichum thermophile Pol eta, 
Sporotrichum thermophile Pol iota, Sporotrichum thermophile Pol kappa, 
and Sporotrichum thermophile REV1. These full length enzymes may be a 
good substitute for Taq polymerase in applications utilizing 
fluorescent nucleoside triphosphate derivatives. These lesion-bypassing 
polymerases could also be included along with a conventional 
thermostable polymerase in a PCR protocol designed to amplify old or 
damaged DNA samples which could greatly increase recoverability, 
accuracy and length of products. Other applications could include 
labelling or tagging DNA, real-time PCR, detection of SNPs, mismatches 
or DNA lesions, mutagenic PCR, directed-evolution methods and expanding 
the ``DNA alphabet'' utilizing non-natural nucleotides.
    Available for licensing are several full length novel Y-family 
polymerases. These enzymes and methods should be of interest to 
forensic DNA service companies as well as to research reagent companies 
pursuing novel thermophilic enzymes for use in ancient and damaged DNA 
analysis and for novel applications with modified nucleotides.
    Inventors: Roger Woodgate and John P. McDonald (NICHD).
    Patent Status: U.S. Provisional Application No. 61/289,901 filed 23 
Dec 2009 (HHS Reference No. E-254-2009/0-US-01).
    Related Patents and Technologies:
    HHS Reference No. E-166-2004/2--
     U.S. Patent Application No. 11/596,783 filed 17 Nov 2006.
     Australian Patent Application No. 2005245966 filed 20 May 
2005.
     Canadian Patent Application No. 2567563 filed 20 May 2005.
     South African Patent Application No. 2006/10533 filed 20 
May 2005.
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; [email protected].
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Laboratory of Genomic Integrity, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the aforementioned thermostable fungal Y-family DNA polymerases. Please 
contact Joseph Conrad, Ph.D. at 301-435-3107 or [email protected] 
for more information.

Compositions and Methods for Immunotherapy

    Description of Invention: Granulysin is a cytolytic and 
proinflammatory molecule expressed by activated human cytotoxic T 
lymphocytes (CTLs) and natural killer (NK) cells. It has been 
implicated in many of diseases including infection, cancer, 
transplantation, autoimmunity, skin and reproductive maladies. Small 
synthetic forms of granulysin are being developed as novel antibiotics 
and studies suggest that granulysin may be a useful diagnostic 
biomarker and/or therapeutic for a wide variety of diseases.
    The invention relates to methods of stimulating or enhancing an 
immune response using 15 kD granulysin. Investigators at the NIH have 
discovered that 15 kD granulysin (but not 9 kD granulysin) activates 
monocytes and induces them to differentiate into mature dendritic cells 
and activates allospecific T cells. This activation and subsequent 
differentiation induced by 15 kD granulysin may prove important in 
inducing or regulating immune responses in a host. Consequently, this 
invention could be used treat tumors and infections, particularly as an 
adjuvant for vaccines and immunotherapies. Further, this technology 
could be used to treat autoimmune disorders and organ transplant 
rejection.
    Applications:
     Stimulating immunity to vaccinations, tumors or 
infections.
     Blocking the induction of an immune response in an 
autoimmune disease or organ transplant rejection.
    Advantages:
     An immune response activator with broad applicability to 
the treatment of several diseases, including cancer, atherosclerosis, 
diabetes, autoimmune disorders, allergies, and infections.
     Co-administering 15kD granulysin could increase the 
efficacy of vaccines and immunotherapeutics.
    Development Status:
     Pre-clinical stage.
     Animal data available.
    Inventors: Alan M. Krensky and Carol Clayberger (NCI).
    Publications:
    1. Stenger S, Hanson DA, Teitlebaum R, Dewan P, Niazi KR, Froelich 
CJ, Ganz T, Thoma-Uszynski S, Meli[aacute]n A, Bogdan C, Porcelli SA, 
Bloom BR,

[[Page 21638]]

Krensky AM, Modlin RL. An antimicrobial activity of cytolytic T cells 
mediated by granulysin. Science 1998 Oct 2;282(5386):121-125. [PubMed: 
9756476]
    2. Krensky AM and Clayberger C. Biology and clinical relevance of 
granulysin. Tissue Antigens 2009 Mar;73(3):193-198. [PubMed: 19254247]
    Patent Status: U.S. Provisional Application No. 61/250,601 filed 12 
Oct 2009 (HHS Reference No. E-158-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney Hastings, M.S.; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The Center for Cancer Research, 
Laboratory of Cellular and Molecular Biology, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact John Hewes, Ph.D. at 301-435-3131 or 
[email protected] for more information.

Fully-Human Monoclonal Antibodies Against Human EphrinB2 and EphB4 for 
Use in the Study of Cancer Pathogenesis

    Description of Invention: Ephrin receptor tyrosine kinases and 
their ephrin ligands have been implicated in cancer pathogenesis. 
Ephrin receptors and ligands affect tumor growth, invasiveness, 
angiogenesis, and metastasis. Ephrin signaling activities in cancer are 
complex and are only now beginning to be uncovered.
    Researchers at the National Cancer Institute-Frederick, NIH, have 
developed a set of five fully-human monoclonal antibodies against human 
Ephrin-B2 and Ephrin type-B receptor 4 (``EphB4''). The antibodies were 
identified by screening a na[iuml]ve human antibody phage display 
library against Ephrin-B2 and EphB4. These human monoclonal antibodies 
have high affinity and specificity for Ephrin-B2 and EphB4.
    Applications:
     Research reagents for in vitro/in vivo investigation of 
Ephrin receptor and ligand interactions.
     Targeting reagents for in vivo imaging.
     Research reagents for protein co-crystallization.
    Advantages:
     High affinity and antigen specificity.
     Bind both soluble ectodomains and cell surface-expressed 
molecules.
    Inventors: Dimiter S. Dimitrov et al. (NCI).
    Patent Status: HHS Reference No. E-331-2008/0 & E-331-2008/1--
Research Material. Patent protection is not being pursued for this 
technology.
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
[email protected].
    Collaborative Research Opportunity: The Center for Cancer Research 
Nanobiology Program is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact John Hewes, 
Ph.D. at 301-435-3131 or [email protected] for more information.

    Dated: April 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-9642 Filed 4-23-10; 8:45 am]
BILLING CODE 4140-01-P