[Federal Register Volume 73, Number 136 (Tuesday, July 15, 2008)]
[Notices]
[Pages 40585-40588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16134]


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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 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

[[Page 40586]]

amino 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; 
[email protected].
    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 
[email protected] 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/[beta]-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; [email protected].
    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 [email protected] 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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[GRAPHIC] [TIFF OMITTED] TN15JY08.001

    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; 
[email protected].
    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 [email protected] 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,

[[Page 40588]]

detection 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; 
[email protected].
    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 [email protected] for more information.

    Dated: July 8, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-16134 Filed 7-14-08; 8:45 am]
BILLING CODE 4140-01-P