Government-Owned Inventions; Availability for Licensing, 17097-17098 [05-6638]

Download as PDF 17097 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices Estimated number of responses per respondent Estimated number of respondents Type of respondents Average burden per response (in hours) Total burden (in hours) Principal Investigators awarded grants funded by PAR 99–006 (Dec. 1999– Nov. 2001) .................................................................................................... 80 1 0.75 60.0 Total .......................................................................................................... ........................ ........................ ........................ 60.0 There is no cost to respondents. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information those who are able to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Veronica Chollette, RN, MS Program Director, Applied Cancer Screening Research Branch, Behavioral Research Program Division of Cancer Control and Population Sciences, National Cancer Institute, 6130 Executive Blvd., Room 4100, Rockville, MD 20852 or call nontoll free number 301–435–2837 or email your request to: vc24a@nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. VerDate jul<14>2003 15:19 Apr 01, 2005 Jkt 205001 Dated: March 21, 2005. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 05–6604 Filed 4–1–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, DHHS. ACTION: Notice. AGENCY: 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. Biomarkers for Tissue Status Joseph Riss and J. Carl Barrett (NCI). U.S. Provisional Application No. 60/ 649,208 filed 01 Feb 2005 (DHHS Reference No. E–064–2005/0–US–01). Licensing Contact: Thomas P. Clouse; (301) 435–4076; clouset@mail.nih.gov. Certain biomarkers are differentially expressed in various tissue samples, including those of renal cancer and in kidney ischemia/reperfusion. The technology relates to methods of quickly and accurately diagnosing and monitoring progression of cancer and PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 ischemically-injured tissue. The technology provides sensitive diagnostic and therapeutic methods using identified biomarkers associated with RCC, acute renal failure, renal regeneration and repair (RRR), organ transplantation and shipment, wound healing, tumors, and organ failure. The potential market for diagnostics and therapeutics in this area is substantial. For example, Renal Cell Carcinoma (RCC) accounts for three (3) percent of all adult male malignancies in the United States. Patent protection for this technology is pending. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Methods of Diagnosing and Treating VHL Associated and Sporadic Renal Cell Carcinoma, and Other VHL Associated and Sporadic Counterpart Tumors Which Co-Express Epo and the Epo Receptor Zhengping Zhuang et al. (NINDS). U.S. Provisional Application No. 60/ 611,616 filed 20 Sep 2004 (DHHS Reference No. E–274–2004/0–US–01). Licensing Contact: Thomas P. Clouse; (301) 435–4076; clouset@mail.nih.gov. While von Hippel-Lindau (VHL) gene germline mutations have been identified as the cause of tumors in VHL patients, the link between gene mutation and tumor development has remained unclear, e.g., it is unknown why only selected organs and cell types are affected. The inventors have discovered that EPO and EPOR are co-expressed in tumors of VHL patients. The coexpression of the EPO and EPO-receptor is also related to the tumor growth and progression in sporadic renal tumors and tumors in kidney dialysis patients. Since the co-expression of EPO and EPOR are not present in most normal adult tissues, ligands that bind to EPOR but do not activate the receptor can target specific tumor cells with minimal detrimental effect on normal cells. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. E:\FR\FM\04APN1.SGM 04APN1 17098 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices Metastasis Suppressor Gene on Human Chromosome 8 and Its Use in the Diagnosis, Prognosis and Treatment of Cancer J. Carl Barrett et al. (NCI). U.S. Provisional Application No. 60/ 591,028 filed 26 Jul 2004 (DHHS Reference No. E–226–2004/0–US–01). Licensing Contact: Mojdeh Bahar; (301) 435–2950; baharm@mail.nih.gov. This invention is directed to an isolated or purified ribonucleic acid (RNA) molecule comprising a nucleotide sequence encoded by a human Tey1 metastasis suppressor gene located at p21–p12 on chromosome 8 or a fragment thereof, wherein the isolated or purified RNA molecule comprises from about 10 to about 100 nucleotides. The invention also provides methods of diagnosis, prognosis, and treatment of cancer, such as prostate cancer, using the isolated or purified RNA molecule. Use of a Promoter of T-Cell Expansion and an Inducer of CD40 Stimulation in the Treatment or Prevention of a Pathologic State William J. Murphy et al. (NCI). U.S. Patent Application No. 10/ 226,959 filed 23 Aug 2002 (DHHS Reference No. E–150–2001/1–US–01). Licensing Contact: Michelle A. Booden; (301) 451–7337; boodenm@mail.nih.gov. Originally described as a protein important in humoral immune responses, it is now known that CD40 plays a wider role in regulating immune function by increasing both costimulatory molecules and antigen presentation. CD40 also contributes to the inflammatory process by inducing the secretion of various inflammatory cytokines including interleukin (IL)–1, IL–6, IL–12, and TNF-a. CD40 is expressed on a variety of cell types including monocytes, dendritic cells, endothelial cells, and carcinomas. The expression of CD40 on a variety of carcinoma cells including but not limited to those of the bladder, kidney, ovary, skin, and breast and the role of CD40 in the promotion of immune function makes CD40 an attractive target for immunotherapy. Single agent modalities in disease therapy often fail, particularly when given for advanced disease. Previous studies have reported that CD40 stimulation can result in significant antitumor effects in various preclinical models. Additionally, various cytokines such as IL–2 and IL–12 have also been shown to have antitumor efficacy in preclinical and clinical trials. The present invention describes a method for treating or preventing a VerDate jul<14>2003 15:19 Apr 01, 2005 Jkt 205001 disease state such as cancer by administrating a combination of a promoter of T-cell expansion, a cytokine such as IL–2 or IL–12, and an inducer of CD40 stimulation. As claimed in the above patent and reported in several publications by Murphy et al, the combination of a cytokine and a CD40 stimulator can result in synergistic antitumor effects in multiple advanced disease models in which neither agent alone resulted in protection or efficacy. This preventative or therapeutic intervention could be directed toward multiple human carcinomas as well as viral, bacterial, or fungal infections and allergic reactions. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Nucleotide and Deduced Amino Acid Sequences of a New Tumor Gene, Int6 Robert Callahan, Antonio Marchetti, Fiamma Buttitta, Gilbert Smith (NCI). U.S. Patent 6,255,104 issued 03 Jul 2001 (DHHS Reference No. E–265–1994/1– US–01), claiming priority to U.S. Patent Application No. 08/385,998 filed 09 Feb 1995, now abandoned (DHHS Reference No. E–265–1994/0–US–01) and PCT Application No. PCT/US96/01884 filed 09 Feb 1996, which published as WO 96/24672 on 15 Aug 1996 (DHHS Reference No. E–265–1994/0–PCT–02). U.S. Patent 6,342,392 issued 29 Jan 2002 (DHHS Reference No. E–265–1994/ 1–US–02). U.S. Patent 6,737,251 issued 18 May 2004 (DHHS Reference No. E–265–1994/ 1–US–03). U.S. Patent Application No. 10/ 783,415 filed 19 Feb 2004 (DHHS Reference No. E–265–1994/1–US–04). Licensing Contact: Jesse Kindra; (301) 435–5559; kindraj@mail.nih.gov. Murine retroviruses have been useful in the identification of mammalian genes involved in tumor development. Five loci have been previously identified as integration sites for one specific retrovirus, mouse mammary tumor virus (MMTV). This work describes a sixth site of integration for MMTV, the Int6 gene. The Int6 gene is highly conserved among vertebrate species, including humans. This invention embodies a series of reagents derived from the nucleic acid and amino acid sequences of the Int6 gene and the use of these reagents in diagnostic methods, immunotherapy, gene therapy, and as vaccines. In addition to licensing, the technology is available for further development through collaborative PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 research opportunities with the inventors. Dated: March 24, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–6638 Filed 4–1–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed 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 following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Spore in Ovarian—GYN Cancer. Date: May 19–20, 2005. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Hotel and Convention Center, 5701 Marinelli Road, North Bethesda, MD 20852 Contact Person: Shamala K. Srinivas, PhD, Scientific Review Administrator, Grants Review Branch, Division of Extramural Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, Room 8133, Bethesda, MD 20892, (301) 594–1224. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: March 24, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee. [FR Doc. 05–6616 Filed 4–1–05; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17097-17098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6638]


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

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.

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

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.

Biomarkers for Tissue Status

Joseph Riss and J. Carl Barrett (NCI).
U.S. Provisional Application No. 60/649,208 filed 01 Feb 2005 (DHHS 
Reference No. E-064-2005/0-US-01).
Licensing Contact: Thomas P. Clouse; (301) 435-4076; 
clouset@mail.nih.gov.

    Certain biomarkers are differentially expressed in various tissue 
samples, including those of renal cancer and in kidney ischemia/
reperfusion. The technology relates to methods of quickly and 
accurately diagnosing and monitoring progression of cancer and 
ischemically-injured tissue. The technology provides sensitive 
diagnostic and therapeutic methods using identified biomarkers 
associated with RCC, acute renal failure, renal regeneration and repair 
(RRR), organ transplantation and shipment, wound healing, tumors, and 
organ failure. The potential market for diagnostics and therapeutics in 
this area is substantial. For example, Renal Cell Carcinoma (RCC) 
accounts for three (3) percent of all adult male malignancies in the 
United States. Patent protection for this technology is pending.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Methods of Diagnosing and Treating VHL Associated and Sporadic Renal 
Cell Carcinoma, and Other VHL Associated and Sporadic Counterpart 
Tumors Which Co-Express Epo and the Epo Receptor

    Zhengping Zhuang et al. (NINDS).
    U.S. Provisional Application No. 60/611,616 filed 20 Sep 2004 (DHHS 
Reference No. E-274-2004/0-US-01).
    Licensing Contact: Thomas P. Clouse; (301) 435-4076; 
clouset@mail.nih.gov.
    While von Hippel-Lindau (VHL) gene germline mutations have been 
identified as the cause of tumors in VHL patients, the link between 
gene mutation and tumor development has remained unclear, e.g., it is 
unknown why only selected organs and cell types are affected. The 
inventors have discovered that EPO and EPOR are co-expressed in tumors 
of VHL patients. The co-expression of the EPO and EPO-receptor is also 
related to the tumor growth and progression in sporadic renal tumors 
and tumors in kidney dialysis patients. Since the co-expression of EPO 
and EPOR are not present in most normal adult tissues, ligands that 
bind to EPOR but do not activate the receptor can target specific tumor 
cells with minimal detrimental effect on normal cells.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

[[Page 17098]]

Metastasis Suppressor Gene on Human Chromosome 8 and Its Use in the 
Diagnosis, Prognosis and Treatment of Cancer

    J. Carl Barrett et al. (NCI).
    U.S. Provisional Application No. 60/591,028 filed 26 Jul 2004 (DHHS 
Reference No. E-226-2004/0-US-01).
    Licensing Contact: Mojdeh Bahar; (301) 435-2950; 
baharm@mail.nih.gov.
    This invention is directed to an isolated or purified ribonucleic 
acid (RNA) molecule comprising a nucleotide sequence encoded by a human 
Tey1 metastasis suppressor gene located at p21-p12 on chromosome 8 or a 
fragment thereof, wherein the isolated or purified RNA molecule 
comprises from about 10 to about 100 nucleotides. The invention also 
provides methods of diagnosis, prognosis, and treatment of cancer, such 
as prostate cancer, using the isolated or purified RNA molecule.

Use of a Promoter of T-Cell Expansion and an Inducer of CD40 
Stimulation in the Treatment or Prevention of a Pathologic State

    William J. Murphy et al. (NCI).
    U.S. Patent Application No. 10/226,959 filed 23 Aug 2002 (DHHS 
Reference No. E-150-2001/1-US-01).
    Licensing Contact: Michelle A. Booden; (301) 451-7337; 
boodenm@mail.nih.gov.
    Originally described as a protein important in humoral immune 
responses, it is now known that CD40 plays a wider role in regulating 
immune function by increasing both costimulatory molecules and antigen 
presentation. CD40 also contributes to the inflammatory process by 
inducing the secretion of various inflammatory cytokines including 
interleukin (IL)-1, IL-6, IL-12, and TNF-[alpha]. CD40 is expressed on 
a variety of cell types including monocytes, dendritic cells, 
endothelial cells, and carcinomas. The expression of CD40 on a variety 
of carcinoma cells including but not limited to those of the bladder, 
kidney, ovary, skin, and breast and the role of CD40 in the promotion 
of immune function makes CD40 an attractive target for immunotherapy.
    Single agent modalities in disease therapy often fail, particularly 
when given for advanced disease. Previous studies have reported that 
CD40 stimulation can result in significant antitumor effects in various 
preclinical models. Additionally, various cytokines such as IL-2 and 
IL-12 have also been shown to have antitumor efficacy in preclinical 
and clinical trials.
    The present invention describes a method for treating or preventing 
a disease state such as cancer by administrating a combination of a 
promoter of T-cell expansion, a cytokine such as IL-2 or IL-12, and an 
inducer of CD40 stimulation. As claimed in the above patent and 
reported in several publications by Murphy et al, the combination of a 
cytokine and a CD40 stimulator can result in synergistic antitumor 
effects in multiple advanced disease models in which neither agent 
alone resulted in protection or efficacy. This preventative or 
therapeutic intervention could be directed toward multiple human 
carcinomas as well as viral, bacterial, or fungal infections and 
allergic reactions.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Nucleotide and Deduced Amino Acid Sequences of a New Tumor Gene, Int6

    Robert Callahan, Antonio Marchetti, Fiamma Buttitta, Gilbert Smith 
(NCI). U.S. Patent 6,255,104 issued 03 Jul 2001 (DHHS Reference No. E-
265-1994/1-US-01), claiming priority to U.S. Patent Application No. 08/
385,998 filed 09 Feb 1995, now abandoned (DHHS Reference No. E-265-
1994/0-US-01) and PCT Application No. PCT/US96/01884 filed 09 Feb 1996, 
which published as WO 96/24672 on 15 Aug 1996 (DHHS Reference No. E-
265-1994/0-PCT-02).
    U.S. Patent 6,342,392 issued 29 Jan 2002 (DHHS Reference No. E-265-
1994/1-US-02).
    U.S. Patent 6,737,251 issued 18 May 2004 (DHHS Reference No. E-265-
1994/1-US-03).
    U.S. Patent Application No. 10/783,415 filed 19 Feb 2004 (DHHS 
Reference No. E-265-1994/1-US-04).
    Licensing Contact: Jesse Kindra; (301) 435-5559; 
kindraj@mail.nih.gov.
    Murine retroviruses have been useful in the identification of 
mammalian genes involved in tumor development. Five loci have been 
previously identified as integration sites for one specific retrovirus, 
mouse mammary tumor virus (MMTV). This work describes a sixth site of 
integration for MMTV, the Int6 gene. The Int6 gene is highly conserved 
among vertebrate species, including humans. This invention embodies a 
series of reagents derived from the nucleic acid and amino acid 
sequences of the Int6 gene and the use of these reagents in diagnostic 
methods, immunotherapy, gene therapy, and as vaccines.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: March 24, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-6638 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-P

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