[Federal Register Volume 70, Number 66 (Thursday, April 7, 2005)]
[Notices]
[Pages 17702-17703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6896]


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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, DHHS.

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.

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.

Identification of Molecular Markers for Endometriosis in Blood 
Lymphocytes Using DNA Microarrays

Idhaliz Flores (NHGRI), et al.
U.S. Provisional Application filed 18 Feb 2005 (DHHS Reference No. E-
068-2005/0-US-01).
Licensing Contact: Marlene Shinn-Astor; (301) 435-4426; 
[email protected].

    Endometriosis is a common, non-malignant gynecological disease that 
affects up to 20% of women during their reproductive years. 
Endometriosis is characterized by the growth of endometrial tissue 
outside the uterus. This growth of tissue causes recurring severe pain 
and can lead to infertility. As the current procedure used for 
diagnosis is invasive and not entirely accurate, there is a need for a 
fast, accurate, and minimally invasive test to test for endometriosis.
    Using DNA microarray analysis of blood lymphocytes, the inventors 
have identified two gene markers expressed in blood that are able to 
discriminate between those women who have endometriosis and those that 
don't. The two gene markers identified are interleukin-2 receptor gamma 
(IL-2RG, a component of cytokine receptors) and lysyl oxidase-like 1 
(LOXL1, which plays an important role in collagen synthesis and has 
also been implicated as a growth regulatory gene). Other genes 
identified in the same manner and which also represent potential 
biomarkers for endometriosis await further validation studies.
    The test would be minimally invasive and quick using a blood sample 
from the patient. Currently, patients must undergo a laparoscopy with 
the diagnosis dependent upon the expertise of the surgeon performing 
the procedure.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Increased Protein Production

Drs. Shankar Adhya and Sudeshna Kar (NCI).
U.S. Provisional Application No. 60/571,943 filed 18 May 2004 (DHHS 
Reference No. E-261-2003/0-US-01).
Licensing Contact: Pradeep Ghosh; (301) 435-5282; [email protected].

    There is a continuing market need to identify biological measures 
to enhance recombinant protein production for therapeutic inventions 
for the treatment of diseases. In general, the field of recombinant 
protein production, including inducement of protein production both by 
cloning and non-cloning methods and incorporation of antibiotic 
resistance genes in vectors appeared to be relatively crowded.

[[Page 17703]]

However, this invention pertains to the creation of a specific 2.4 kb 
gene cassette that includes a specific gene that confers resistance to 
aminoglycoside antibiotics, increases protein levels inside a cell and 
increases yield of production of recombinatant proteins, when inserted. 
In particular, the inventors have identified a specific gene aadA1 
(adenyltransferase gene) that codes for a 28.876 Kd protein that 
normally confers aminoglycoside resistance to cells. Further, the 
inventors have found that a ``gene cassette'' carrying the aadA1 gene 
which when transferred to bacterial strains induces enhancement of 
protein production and accumulation. Additionally, this inducement is 
not restricted by the nature of the vector, induction system or nature 
of protein. In short, the invention provides a method of reconstruction 
of a cell for increased yield of recombinant protein, which involves a 
``one-step procedure of induction of a new gene into the cell.'' 
Therefore, the technology may have a substantial commercial value to 
the pharmaceutical industry.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Endothelial Protective Actions of Cytochrome P450 Epoxygenase-derived 
Eicosanoids

Darryl C. Zeldin (NIEHS), et al.
U.S. Patent Application No. 09/634,369 filed 09 Aug 2000, notice of 
allowance issued (DHHS Reference No. E-252-1999/0-US-02).
Licensing Contact: Marlene Shinn-Astor; (301) 435-4426; 
[email protected].

    Cytochrome P450s catalyze the NADPH-dependent oxidation of 
arachidonic acid to various eicosanoids found in several species 
including humans. The eicosanoids are biosynthesized in numerous 
tissues including pancreas, intestine, kidney, heart, and lung where 
they are involved in many different biological activities.
    The NIH announces a new therapy wherein epoxyeicosatrienoic acid 
(EET) compositions have been found to be useful in preventing 
endothelial cell death due to hypoxia-reoxygenation. Given that 
endothelial injury is an important early event in the development of 
the atherosclerotic plaque and is associated with myocardial 
dysfunction in ischemic heart disease, reduced EET levels are 
speculated to be involved in the pathogenesis of these cardiovascular 
disorders.
    This research is described in Yang et al., Molecular Pharmacology 
60: 310-320, 2001.

T-Cell Receptor Alternate Reading Frame Protein, (TARP) and Uses 
Thereof

Ira Pastan, Magnus Essand, Byungkook Lee, George Vasmatzis, Ulrich 
Brinkman, Paul Duray, and Curt Wolfgang (NCI).
U.S. Patent Application No. 10/031,158 filed 11 Jan 2002, and multiple 
National Stage foreign filings (DHHS Reference No. E-104-1999/2).
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    This invention relates to a tumor-associated protein, TARP, which 
is expressed in breast and prostate cancer cells. This antigen target 
might be a useful tool for the diagnosis and treatment of breast and 
prostate cancer. TARP has shown efficacy in vivo as a potential 
therapeutic for the treatment of cancer. TARP has been the subject of 
several publications, including: J. Biol. Chem. (2004 Jun 4) 
279(23):24561-24568, Epub 2004 Mar 29 as doi:10.1074/jbc.M402492200; 
Cancer Res. (2004 Apr 1) 64(7):2610-2618; Endocrinology (2003 Aug) 
144(8):3433-40; Cancer Res. (2001 Nov 15) 61(22):8122-8126; Proc. Natl. 
Acad. Sci. USA (2000 Aug 15) 97(17):9437-9442.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Method for Reducing the Immunogenicity of Antibody Variable Domains

Eduardo Padlan (NIDDK) et al.
U.S. Patent No. 6,797,492 issued 28 Sep 2004 (DHHS Ref. No. E-163-1991/
2-US-02)
Licensing Contact: Jeff Walenta; (301) 435-4633; [email protected].

    The current invention addresses a limitation of monoclonal 
antibodies used in immunotherapy. Monoclonal antibodies with high 
selectivity for human antigens are commonly produced in mice. However, 
when introduced into humans for therapy, the antibodies can be 
neutralized by the human immune system and their duration and 
effectiveness limited. Modification of non-human antibodies to avoid 
the human immune system often produces antibodies with reduced affinity 
for the antigen and which remain antigenic in humans.
    The current invention provides a method for producing ``humanized'' 
antibodies that retain antigen binding properties but which have 
eliminated or reduced antigenicity. The method comprises substituting 
residues in the variable region of the non-human antibody with residues 
found in the variable region of human antibodies, with particular 
emphasis on residues that are solvent exposed and that are not adjacent 
to complementarity determining regions.
    When tested in monkeys, the serum longevity of the ``veneered'' 
antibodies produced by the current invention was significantly greater 
than that of mouse antibodies or chimeric mouse-human antibodies. 
Accordingly, the technology could enhance the effectiveness of 
monoclonal antibodies designed for therapy of cancer or other diseases.

    Dated: March 25, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-6896 Filed 4-6-05; 8:45 am]
BILLING CODE 4140-01-P