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Government-Owned Inventions; Availability for Licensing

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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.

Neutralization of Hepatitis C Virus (HCV)

Description of Technology: Available for licensing and commercial development are anti-hepatitis C virus (HCV) vaccines, therapeutics and inhibitors. The invention is based on mapping studies conducted by the inventors of two epitopes within HCV E2: epitope I and epitope II. It has been discovered that epitope I is involved in virus neutralization but that epitope II mediates antibody interference; probably an adaptation of the virus to obfuscate the immune system. The present invention provides compositions and methods for treating and or preventing HCV infection caused by HCV. The invention is directed to a HCV E2 polypeptide substitution of Start Printed Page 40586amino acids LFY of the skein LFY in epitope II. In certain embodiments, the invention is directed to a HCV E2 polypeptide deletion of amino acids LFY of the skein LFY in epitope II. In additional embodiments, the invention is directed to a HCV E2 polypeptide addition of amino acids between LFY of the skein LFY in epitope II. The above are directed to attenuating or disabling the interference effect of HCV-E2 epitope II.

In additional embodiments, the invention is directed to use of epitope II as a molecular decoyant. In further embodiments, the invention is directed to use of epitope II to affinity purify an immune globulin to deplete interfering antibodies from and enrich neutralizing antibodies in the preparation.

Applications: Antiviral; Hepatitis C Virus (HCV) therapy.

Inventors: Pei Zhang, Marian Major, Stephen Feinstone (FDA).

Publications:

1. P Zhang et al. Hepatitis C virus epitope-specific neutralizing antibodies in Igs prepared from human plasma. Proc Natl Acad Sci USA. 2007 May 15;104(20):8449-8454.

2. MY Yu et al. Neutralizing antibodies to hepatitis C virus (HCV) in immune globulins derived from anti-HCV-positive plasma. Proc Natl Acad Sci USA. 2004 May 18;101(20):7705-7710.

Patent Status: U.S. Provisional Application No. 61/002,031 filed 06 Nov 2007 (HHS Reference No. E-276-2007/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: RC Tang, JD, LLM; 301-435-5031; tangrc@mail.nih.gov.

Collaborative Research Opportunity: The FDA Center for Biologics Evaluation and Research, Laboratory of Plasma Derivatives, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Michelle Hawley at 301-827-1991 or michelle.hawley@fda.hhs.gov for more information.

Treatment of Skin Conditions Using DKK1

Description of Technology: This invention discloses a method for inducing non-palmoplantar skin (skin of the trunk, arms, and face etc.) to develop characteristics of palmoplantar skin (skin of the soles and palms). This effect is achieved by use of Dickkopf 1 (DKK1), a protein which is highly expressed by palmoplantar fibroblasts and is a known antagonist of the Wnt signaling pathway. Topical application of DKK1 to non-palmoplantar skin induces the development of increased skin thickness, decreased pigmentation, and decreased hair growth. These characteristics are desirable for treating several dermatological conditions.

The skin thickening caused by topical application of DKK1 can be useful for skin grafts, and skin ulcers or abrasions. Decreased skin pigmentation, experimentally achieved by either topical or in vitro application of DKK1, may be desirable for conditions such as uneven skin pigmentation, pigmented birthmarks, or post inflammatory pigmentation. Suppressed hair growth may be cosmetically desirable for some areas of the skin, and in conditions such hypertrichosis, adrenal hyperplasia, or polycystic ovarian syndrome. DKK1 treatment may also be important for treating or preventing certain melanomas which involve hyperplastic or pre-malignant lesions.

Applications: Useful for skin grafts, skin ulcers, skin abrasions, fragrance dermatitis, vitiligo, etc.; Treatment of several conditions which require decreased skin pigmentation; Decreased hair growth for cosmetic or therapeutic purposes.

Development Status: Early stage.

Inventors: Vincent J. Hearing et al. (NCI).

Publication: Y Yamaguchi, T Passeron, T Hoashi, H Watabe, F Rouzaud, K Yasumoto, T Hara, C Tohyama, I Katayama, T Miki, VJ Hearing. Dickkopf 1 (DKK1) regulates skin pigmentation and thickness by affecting Wnt/β-catenin signaling in keratinocytes. FASEB J. 2008 Apr;22(4):1009-1020.

Patent Status:

U.S. Provisional Application No. 60/873,874 filed 07 Dec 2006 (HHS Reference No. E-321-2006/0-US-01).

PCT Application No. PCT/US2007/086855 filed 07 Dec 2007 (HHS Reference No. E-321-2006/0-PCT-02).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Jasbir (Jesse) S. Kindra, J.D., M.S.; 301-435-5170; kindraj@mail.nih.gov.

Collaborative Research Opportunity: The National Cancer Institute Laboratory of Cell Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of DKK1 or a bioactive fragment of DKK1 to treat abnormal pigmentation of the skin or to regulate hair growth. Please contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.

Flow-Through Thermal-Expansion-Compensated Microcells for Analytical Transmission Infrared Spectroscopy

Description of Technology: Available for licensing and commercial distribution are optical cells spectroscopically stable and can be used for spectroscopic measurement in transmission, sample reflection, back plate reflection, emission, or scattering modes. The cell allows fluid in a sample space to be exchanged without separating a front or a back plate from a spacer, allows a solid sample to be placed in or removed from the sample space, requires only a small amount of sample, and allows for different sample gaps to be easily and inexpensively set. Alternatively, the spacers can be manufactured using a hydrocarbon-resistant polymer so that samples dissolved in organic solvents can be used without the risk of changing the spectral properties of the microcell and solvent leakage from the sample space. The inventive cell and methods allow spectral measurements to be taken over wavelengths ranging at least from the mid-infrared to the vacuum ultraviolet, provide a simple path for light traveling through a sample, and allow fast kinetic processes to be detected and monitored reproducibly and sensitively.

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Applications: Analytics; Spectroscopy; Infrared spectroscopy; Chemical Imaging; Material characterization; Quality control; Chemometrics in chemical and pharmaceutical manufacturing; Forensic applications; Tissue pathology diagnostics

Inventors: Edward Mertz and James Sullivan (NICHD).

Publications:

1. Makareeva E, Mertz EL, Kuznetsova NV, Sutter MB, DeRidder AM, Cabral WA, Barnes AM, McBride DJ, Marini JC, Leikin S. Structural heterogeneity of type I collagen triple helix and its role in osteogenesis imperfecta. J Biol Chem. 2008 Feb 22;283(8):4787-4798.

2. Mertz EL, Leikin S. Interactions of inorganic phosphate and sulfate anions with collagen. Biochemistry. 2004 Nov 30;43(47):14901-14912.

Patent Status:

U.S. Patent 7,355,697 issued 08 Apr 2008 (HHS Reference No. E-096-2004/0-US-01).

International Patent Application No. PCT/US2005/030218 filed 25 Aug 2005, which published as WO 2006/026342 on 09 Mar 2006 (HHS Reference No. E-096-2004/0-PCT-02).

European Patent Application 05786373.9 filed 26 Aug 2005 (HHS Reference No. E-096-2004/0-EP-03).

U.S. Patent Application No. 11/826,806 filed 18 Jul 2007 (HHS Reference No. E-096-2004/1-US-01).

Licensing Status: Available for non-exclusive or exclusive licensing.

Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019; shmilovm@mail.nih.gov.

Collaborative Research Opportunity: The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Section on Physical Biochemistry is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize microcells for infrared and other spectroscopies and their applications to pathology diagnostics. Please contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.

Rapid and Sensitive Detection of Nucleic Acid Sequence Variations

Description of Technology: The ability to easily detect small mutations in nucleic acids, such as single base substitutions, can provide a powerful tool for use in cancer detection, perinatal screens for inherited diseases, and analysis of genetic polymorphisms such as genetic mapping or for identification purposes. Current approaches make use of the mismatch that occurs between complimentary strands of DNA when there is a genetic mutation, the electrophoretic mobility differences caused by small sequence changes, and chemicals or enzymes that can cleave heteroduplex sites. Some of these methods, however, prove to be too cumbersome, are unable to pinpoint mutations, only detect a subset of mutations, or involve the use of hazardous materials.

The current invention takes advantage of the ability of transposons, or mobile genetic elements, to move from one part of the genome to another by the cleavage and joining of their sequences into the target site; a reaction facilitated by a transposase enzyme. The phage Mu transposase is capable of inserting the right end sequence of the Mu transposon into any DNA sequence both in vitro and in vivo. The surprising discovery that the Mu transposase displays a strong preference for inserting Mu-end DNA into mismatched sites, the very sites which occur when DNA is mutated and paired with its complementary strand that does not have the corresponding mutation, makes it a powerful tool for detecting variations in nucleic acid sequences. In this system, the transposition of Mu-end DNA at a site is used to indicate the presence of a nucleic acid mismatch or mutation at that site. The invention can be used with labeled Mu-end DNA to further facilitate the precise mapping of the mutations. This specificity allows Mu to detect even single base mutations among a large quantity of non-specific DNA. The Mu detection system is simple, rapid, and highly sensitive compared to current methods and can find a broad range of use in genetic research and the diagnosis of several diseases such as cystic fibrosis, spinal and bulbar muscular dystrophy, human fragile-X syndrome, and Huntington's disease.

Applications:

Fast, simple screening for genetic mutations in several diseases such as cystic fibrosis, spinal and bulbar muscular dystrophy, human fragile-X syndrome, Huntington's disease, Start Printed Page 40588detection of birth defects, and paternity testing, etc.

Genetic mapping and identification.

Development Status: Early stage.

Inventors: Katsuhiko Yanagihara and Kiyoshi Mizuuchi (NIDDK).

Publication: Yanagihara K and Mizuuchi K. Mismatch-targeted transposition of Mu: a new strategy to map genetic polymorphism. Proc Natl Acad Sci USA. 2002 Aug 20; 99(17):11317-11321.

Patent Status: U.S. Patent No. 7,316,903 issued 08 Jan 2008 (HHS Reference No. E-071-2003/0-US-02).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Jasbir (Jesse) S. Kindra, JD, MS; 301-435-5170; kindraj@mail.nih.gov.

Collaborative Research Opportunity: The Section on Genetic Mechanisms, LMB, NIDDK is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Mu transposition system as a tool for mutation detection and other genetic research/manipulation. Please contact Kiyoshi Mizuuchi at kmizu@helix.nih.gov for more information.

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Dated: July 8, 2008.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E8-16134 Filed 7-14-08; 8:45 am]

BILLING CODE 4140-01-P