Government-Owned Inventions; Availability for Licensing, 72452-72453 [E5-6803]

Download as PDF 72452 Federal Register / Vol. 70, No. 232 / Monday, December 5, 2005 / Notices for formation of a collimated Gaussian laser beam profile for IOL testing. Third, the tip serves as a highly sensitive point receiver of the back reflectance laser emission. Fourth, the fiber coupler provides delivery of the spatially separated back reflected laser emission to a detector system. The combination of these unique features of the confocal fiber-optic laser method provides high accuracy (exceeding 1 µm) in spatially locating the IOL focal point and measuring the IOL power. A unique feature of this method is that it allows for measurement of a wide range of both positive and negative powers including high-magnification IOL’s with power greater than ±20 diopters. The simple and high-sensitive IOL power testing method will provide the CDRH/FDA and the scientific community with an independent source of measurement data and information for evaluating the effectiveness and safety of novel IOL products. Minimally Immunogenic Variants of SDR-Grafted Humanized Antibody CC49 and Their Use Syed Kashmiri (NCI), Jeffrey Schlom (NCI), and Eduardo Padlan (NIDDK) U.S. Provisional Application No. 60/ 493,903 filed 29 Aug 2003 (HHS Reference No. E–323–2003/0-US–01) and PCT Application No. PCT/US04/ 28004 filed 27 Aug 2004 (HHS Reference No. E–323–2003/0-PCT– 02). Licensing Contact: Michelle Booden; 301/451–7337; boodenm@mail.nih.gov. Tumor Associated Glycoprotein 72 (TAG)–72 is an oncofetal antigen expressed on a majority of human carcinomas, including colorectal, gastric, pancreatic, breast, lung, and ovarian. The murine monoclonal antibody (mAb) CC49 specifically recognizes TAG–72 and has a higher affinity for TAG–72 than its predecessor, B72.3. The present invention relates to humanized monoclonal antibodies that have high binding affinity for the tumorassociated glycoprotein (TAG)–72 with minimal immunogenicity. This antiTAG–72 antibody binds to the same epitope as the CC49 murine variant developed at the National Cancer Institute. The variants of CC49 described in this patent application have been shown to have a decreased immune response, with comparable binding affinity, than the parent murine antibodies. These variants have potential benefits for use in the detection and/or treatment of a range of human carcinomas. Certain fields of use may not be available. VerDate Aug<31>2005 17:14 Dec 02, 2005 Jkt 208001 Please contact OTT for information regarding the availability of specific fields of use. This variant was published in Kashmiri et al., ‘‘Minimizing Immunogenicity of the SDR-grafted Humanized Antibody CC49 by Genetic Manipulation of the Framework Residues,’’ Molecular Immunology, 40 (2003), 337–349. Restenosis/Atherosclerosis Diagnosis, Prophylaxis, and Therapy Toren Finkel et al. (NHLBI) U.S. Patent No. 6,183,752 issued 06 Feb 2001 (HHS Reference No. E–258– 1994/0-US–01) Licensing Contact: Fatima Sayyid; 301/ 435–4521; sayyidf@mail.nih.gov. This technology relates to the compositions and methods for the diagnosis, prevention, and therapy of restenosis and atherosclerosis. It involves the use of an agent for decreasing viral load, preferably a vaccine, against cytomegalovirus (CMV) and p53, including a method for providing the therapy and administering the agent. This invention thus relates to stimulating an immune response, preferably a cellular immune response, directed against CMV and p53 to inhibit or prevent restenosis, atherosclerosis, and smooth muscle proliferation. Therefore, the technology offers methods for inducing cell death with the purpose of inhibiting smooth muscle proliferation as a means of preventing or treating restenosis and atherosclerosis. Dated: November 14, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E5–6802 Filed 12–2–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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. Mitotic Spindle ASPM as a Diagnostic Marker for Neoplasia and Uses Thereof Paul K. Goldsmith, Vladmir Larionov, Natalay Kouprina and John I. Risinger (NCI) U.S. Provisional Application No. 60/ 696,212 filed 01 Jul 2005 (HHS Reference No. E–210–2005/0–US–01) Licensing Contact: Mojdeh Bahar; 301/ 435–2950; baharm@mail.nih.gov. Cancer is responsible for approximately 23% of deaths in the United States of America. A high percentage of these deaths are caused by the lack of a precise diagnostic method that can detect malignancy in a particular tissue at an early stage. This invention provides for diagnostic methods, compositions, and kits that are useful for identifying neoplasia by measuring Abnormal Spindle-like Microcephaly associated (ASPM) expression in a patient sample. The ASPM gene is the human ortholog of the Drosophila melanogaster ‘abnormal spindle’ gene (asp), which is essential for normal mitotic spindle function in embryonic neuroblasts. By measuring ASPM expression levels one can also determine if a particular subject has a higher propensity to develop neoplasia. This invention is particularly useful in detecting neoplasia in hard to diagnose cancers like ovarian and uterine cancer. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Monoclonal Antibodies That Bind or Neutralize Hepatitis B Virus Robert H. Purcell (NIAID) et al. U.S. Provisional Application No. 60/ 644,309 filed 14 Jan 2005 (HHS Reference No. E–144–2004/0-US–01) Licensing Contact: Chekesha S. Clingman; 301/435–5018; clingmac@mail.nih.gov.. Hepatitis B virus (HBV) chronically infects over 300 million people worldwide. Many of them will die of chronic hepatitis or hepatocellular E:\FR\FM\05DEN1.SGM 05DEN1 Federal Register / Vol. 70, No. 232 / Monday, December 5, 2005 / Notices carcinoma. The present technology relates to the isolation and characterization of a novel neutralizing chimpanzee monoclonal antibody to HBV. The antibody was identified through a combinatorial antibody library constructed from bone marrow cells of a chimpanzee experimentally infected with HBV. The selected monoclonal antibody has been shown to react equally well with wild-type HBV and the most common neutralization escape mutant variants. Therefore, this monoclonal antibody with high affinity and broad reactivity may have distinct advantages over other approaches to immunoprophylaxis and immunotherapy of chronic HBV infection, as most of the monoclonal antibodies currently in use are not sufficiently and broadly reactive to prevent the emergence of neutralization escape mutants of HBV. This technology describes such antibodies, fragments of such antibodies retaining hepatitis B virus-binding ability, fully human or humanized antibodies retaining hepatitis B virus-binding ability, and pharmaceutical compositions including such antibodies. This invention further describes isolated nucleic acids encoding the antibodies and host cells transformed with nucleic acids. In addition, this invention provides methods of employing these antibodies and nucleic acids in the in vitro and in vivo diagnosis, prevention and therapy of HBV diseases. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Polypeptide Multimers Having Antiviral Activity Carol Weiss et al. (FDA) PCT Application No. PCT/US03/25295 filed 14 Aug 2003, which published as WO 2005/018666 on 03 Mar 2005 (HHS Reference No. E–155–2003/0PCT–01) Licensing Contact: Susan Ano; 301/435– 5515; anos@mail.nih.gov. The technology describes polypeptide multimers that have antiviral and immunogenic activity against HIV. These multimers consist of at least one monomer of the highly conserved N and C heptad regions of gp41 in a ratio of at least 2:1 N to C heptad, with the N and C heptads being connected by linkers. The monomer forms homodimers and homotrimers in solution and mimic fusion intermediate structure. Further, the technology also describes a method of raising a broadly neutralizing antibody response to HIV by administering the polypeptide VerDate Aug<31>2005 17:14 Dec 02, 2005 Jkt 208001 multimers mentioned above. Thus, these polypeptide multimers may be used as antiviral (anti-HIV) agents. Because the structure of these polypeptide multimers mimics the gp41 fusion intermediate, they can also be used to identify compounds that may inhibit the fusion process. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Dated: November 15, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E5–6803 Filed 12–2–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the meeting of the Advisory Committee to the Director, National Institutes of Health (NIH). The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. A portion of the meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(6) and 552b(c)(9)(B), Title 5 U.S.C., as amended, because the disclosure of which would constitute a clearly unwarranted invasion of personal privacy and the premature disclosure of information and the discussions would likely to significantly frustrate implementation of the program. Name of Committee: Advisory Committee to the Director, NIH. Date: December 1–2, 2005. Closed: December 1, 2005, 8:30 a.m. to 9:45 a.m. Agenda: Office of Portfolio Analysis and Strategic Initiatives (OPASI). Place: National Institutes of Health, 9000 Rockville Pike, Building 31, Conference Room 6, Bethesda, MD 20892. Open: December 1, 2005, 10 a.m. to 4:30 p.m. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 72453 Agenda: Among the topics proposed for discussion are: (1) NIH Director’s Report; (2) Clinical and Translational Science Awards; (3) NIH Director’s Council of Public Representatives Liaison Report; and (4) update on NIH Neurosciences Blueprint. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, Conference Room 6, Bethesda, MD 20892. Open: December 2, 2005, 9 a.m. to 12 p.m. Agenda: Among the topics proposed for discussion are: (1) Office of Portfolio Analysis and Strategic Initiatives (OPASI); (2) Public Access Update; and (3) Workgroup Report on Outside Awards for NIH Employees. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, Conference Room 6, Bethesda, MD 20892. Contact Person: Shelly Pollard, ACD Coordinator, Office of Communications and Public Liaison, Office of the Director, National Institutes of Health, 31 Center Drive, Building 31, Room 5B64, Bethesda, MD 20892, Phone: (301) 496–0959, pollards@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance into the building by non-government employees. Persons without a government I.D. will need to show a photo I.D. and signin at the security desk upon entering the building. Information is also available on the Institute’s/Center’s home page: https:// www.nih.gov/about/director/acd.htm where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: November 22, 2005. Nancy Middendorf, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–23590 Filed 12–2–05; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\05DEN1.SGM 05DEN1

Agencies

[Federal Register Volume 70, Number 232 (Monday, December 5, 2005)]
[Notices]
[Pages 72452-72453]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-6803]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

Mitotic Spindle ASPM as a Diagnostic Marker for Neoplasia and Uses 
Thereof

Paul K. Goldsmith, Vladmir Larionov, Natalay Kouprina and John I. 
Risinger (NCI)
U.S. Provisional Application No. 60/696,212 filed 01 Jul 2005 (HHS 
Reference No. E-210-2005/0-US-01)
Licensing Contact: Mojdeh Bahar; 301/435-2950; baharm@mail.nih.gov.

    Cancer is responsible for approximately 23% of deaths in the United 
States of America. A high percentage of these deaths are caused by the 
lack of a precise diagnostic method that can detect malignancy in a 
particular tissue at an early stage. This invention provides for 
diagnostic methods, compositions, and kits that are useful for 
identifying neoplasia by measuring Abnormal Spindle-like Microcephaly 
associated (ASPM) expression in a patient sample. The ASPM gene is the 
human ortholog of the Drosophila melanogaster `abnormal spindle' gene 
(asp), which is essential for normal mitotic spindle function in 
embryonic neuroblasts. By measuring ASPM expression levels one can also 
determine if a particular subject has a higher propensity to develop 
neoplasia. This invention is particularly useful in detecting neoplasia 
in hard to diagnose cancers like ovarian and uterine cancer.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Monoclonal Antibodies That Bind or Neutralize Hepatitis B Virus

Robert H. Purcell (NIAID) et al.
U.S. Provisional Application No. 60/644,309 filed 14 Jan 2005 (HHS 
Reference No. E-144-2004/0-US-01)
Licensing Contact: Chekesha S. Clingman; 301/435-5018; 
clingmac@mail.nih.gov..

    Hepatitis B virus (HBV) chronically infects over 300 million people 
worldwide. Many of them will die of chronic hepatitis or hepatocellular

[[Page 72453]]

carcinoma. The present technology relates to the isolation and 
characterization of a novel neutralizing chimpanzee monoclonal antibody 
to HBV. The antibody was identified through a combinatorial antibody 
library constructed from bone marrow cells of a chimpanzee 
experimentally infected with HBV. The selected monoclonal antibody has 
been shown to react equally well with wild-type HBV and the most common 
neutralization escape mutant variants. Therefore, this monoclonal 
antibody with high affinity and broad reactivity may have distinct 
advantages over other approaches to immunoprophylaxis and immunotherapy 
of chronic HBV infection, as most of the monoclonal antibodies 
currently in use are not sufficiently and broadly reactive to prevent 
the emergence of neutralization escape mutants of HBV. This technology 
describes such antibodies, fragments of such antibodies retaining 
hepatitis B virus-binding ability, fully human or humanized antibodies 
retaining hepatitis B virus-binding ability, and pharmaceutical 
compositions including such antibodies. This invention further 
describes isolated nucleic acids encoding the antibodies and host cells 
transformed with nucleic acids. In addition, this invention provides 
methods of employing these antibodies and nucleic acids in the in vitro 
and in vivo diagnosis, prevention and therapy of HBV diseases.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Polypeptide Multimers Having Antiviral Activity

Carol Weiss et al. (FDA)
PCT Application No. PCT/US03/25295 filed 14 Aug 2003, which published 
as WO 2005/018666 on 03 Mar 2005 (HHS Reference No. E-155-2003/0-PCT-
01)
Licensing Contact: Susan Ano; 301/435-5515; anos@mail.nih.gov.

    The technology describes polypeptide multimers that have antiviral 
and immunogenic activity against HIV. These multimers consist of at 
least one monomer of the highly conserved N and C heptad regions of 
gp41 in a ratio of at least 2:1 N to C heptad, with the N and C heptads 
being connected by linkers. The monomer forms homodimers and 
homotrimers in solution and mimic fusion intermediate structure. 
Further, the technology also describes a method of raising a broadly 
neutralizing antibody response to HIV by administering the polypeptide 
multimers mentioned above. Thus, these polypeptide multimers may be 
used as antiviral (anti-HIV) agents. Because the structure of these 
polypeptide multimers mimics the gp41 fusion intermediate, they can 
also be used to identify compounds that may inhibit the fusion process.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: November 15, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E5-6803 Filed 12-2-05; 8:45 am]
BILLING CODE 4140-01-P
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