Prospective Grant of Exclusive License: FDA Cleared Pediatric Cancer Diagnostics and Prognostics, 49289-49290 [E7-16930]

Download as PDF Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Notices form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.879, Medical Library Assisance, National Institutes of Health, HHS) Dated: August 22, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–4215 Filed 8–27–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Closed Meetings pwalker on PROD1PC71 with NOTICES 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 meetings. The meetings 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 Library of Medicine Special Emphasis Panel; G08–R01– R21. Date: October 15, 2007. Time: 1 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Zoe E. Huang, MD, Health Scientific Administrator, Extramural Programs, National Library of Medicine, Rockledge 1 Building, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968, 301– 594–4937, huangz@mail.nih.gov. Name of Committee: Biomedical Library and Informatics Review Committee. Date: November 6–7, 2007. Time: November 6, 2007, 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, Building 38, 2nd Floor, Board Room, 9000 Rockville Pike, Bethesda, MD 20894. Time: November 7, 2007, 8 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. VerDate Aug<31>2005 19:52 Aug 27, 2007 Jkt 211001 Place: National Library of Medicine, Building 38, 2nd Floor, Board Room, 9000 Rockville Pike, Bethesda, MD 20894. Contact Person: Arthur A. Petrosian, PhD, Scientific Review Administrator, Division of Extramural Programs, National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968, 301–496–4253, petrosia@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 onto the NIH campus. All visitor vehicles, including taxicabs. hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: August 22, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–4223 Filed 8–27–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: FDA Cleared Pediatric Cancer Diagnostics and Prognostics National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(I), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in Patent Applications U.S. 10/133,937, filed 04/25/2002, entitled ‘‘Methods for Analyzing High Dimensional Data for Classifying, Diagnosing, Prognosticating and/or Predicting Diseases and Other Biological States’’; and U.S. 10/159,563, filed 05/ 31/2002, entitled ‘‘Selections of Genes And Methods of Using The Same For Diagnosis And For Targeting The Therapy of Select Cancers’’; to Althea Technologies, Inc. having a place of business in San Diego, California. The patent rights in this invention have been PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 49289 assigned to the United States of America (PHS ref E–324–2001/0,1). DATE: Only written comments and/or application for a license that are received by the NIH Office of Technology Transfer on or before October 29, 2007 will be considered. ADDRESS: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Cristina Thalhammer-Reyero, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; e-mail: ThalhamC@mail.nih.gov; Telephone: 301–435–4507; Facsimile: 301–402– 0220. SUPPLEMENTARY INFORMATION: The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. The invention relates to a method of using supervised pattern recognition methods for classifying, diagnosing, predicting, or prognosticating various diseases. The method includes obtaining high dimensional experimental data, such as gene expression profiling data, filtering the data, reducing the dimensionality of the data through use of one or more methods, training artificial neural networks (ANN, a supervised pattern recognition method), ranking individual data points from the data, choosing multiple data points from the data based on the relative ranking, and using the multiple data points to determine if an unknown set of experimental data indicates a diseased condition, a predilection for a diseased condition, or a prognosis about a diseased condition. Further, the invention relates to sets of genes expressed in cancer cells that function to characterize each cancer type, and methods of using the sets of genes for diagnosis and for targeting the therapy of selected cancers. In particular, the methods apply to classify cancers which often present diagnostic dilemmas in clinical practice, such as the pediatric small round blue cell tumors (SRBCTs), including neuroblastoma (NB), rhabdomyosarcoma (RMS), Burkitt’s lymphoma (BL), and the Ewing family of tumors (EWS). Specifically, the invention is an application of ANNs for E:\FR\FM\28AUN1.SGM 28AUN1 49290 Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Notices the diagnostic classification of cancers based on gene expression profiling data derived from cDNA microarrays. The ANNs were first trained to be used as models, and then correctly classified all samples tested and identified the genes most relevant to the classification. Their study demonstrated the potential applications of these methods for tumor diagnosis and for the identification of candidate targets for therapy. The uniqueness of this method is taking gene expression data generated by microarrays, minimizing the genes from the original 1000s to less than 100, identifying which genes are the most relevant to a classification, which gives an immediate clue to the actual biological processes involved, not just surrogate markers which have no bearing on the biology. The field of use may be limited to ‘‘FDA Cleared Pediatric Cancer Diagnostics and Prognostics’’. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: August 20, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–16930 Filed 8–27–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Method for Determining the Redox Status of a Tissue National Institutes of Health, Public Health Service, HHS. ACTION: Notice. pwalker on PROD1PC71 with NOTICES AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(I), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: PCT Application No. PCT/ US2006/031208 (E–258–2005/0–PCT– 02) filed August 10, 2006 claiming priority to U.S. Provisional Application No. 60/707,518 (E–258–2005/0–US–01), titled ‘‘Method for Determining the VerDate Aug<31>2005 19:52 Aug 27, 2007 Jkt 211001 Redox Status of a Tissue’’ (Inventors: Dr James Mitchell et al.) to Mitos Pharmaceutical, Inc. (hereafter Mitos), having a place of business in Newport Beach, California. The patent rights in these inventions have been assigned to the United States of America. DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before October 29, 2007 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Chekesha Clingman, PhD, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; e-mail: clingmac@mail.nih.gov; Telephone: (301) 435–5018; Facsimile: (301) 402–0220. SUPPLEMENTARY INFORMATION: The present invention relates to a method of determining the redox status of tissues by administering a cell-permeable nitroxide, such as 4-hydroxy-2,2,6,6tetramethylpiperidine-1-oxyl (or Tempol), as a contrast agent and employing magnetic resonance imaging (MRI). Also provided by the invention are a method for diagnosing a tumor and other pathologies associated with oxidative stress and a method for determining a cancer treatment protocol. Tumor tissues exhibit viable but hypoxic regions that allow them to reduce nitroxide compounds more efficiently than normal tissue. The paramagnetic relaxivity of nitroxide compounds makes it possible to use standard MRI scanners to determine the redox status of tissue in vivo. By determining the redox status of a tumor it is possible to not only diagnose a tumor due to its enhanced reduction of intracellular nitroxide contrast agent, but also to determine appropriate radiation treatment fields spatially to deliver therapeutic doses of radiation, and to determine appropriate timing sequences after the administration of a nitroxide contrast agent such that the maximum difference between normal and tumor tissue with respect to the radioprotective form of the nitroxide is present in the normal tissue, thereby limiting collateral damage to the normal tissue. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. The field of use may be limited to methods for determining the redox status of tissues by utilizing nitroxide contrast agents in combination with MRI for diagnosis of cancer and other pathologies. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: August 20, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–16931 Filed 8–27–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Policy for Sharing of Data Obtained in NIH Supported or Conducted GenomeWide Association Studies (GWAS) AGENCY: National Institutes of Health, HHS. ACTION: Notice. Background The NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition.1 Whole genome information, when combined with clinical and other phenotype data, offers the potential for increased understanding of basic biological processes affecting human health, improvement in the prediction of disease and patient care, and 1 To meet the definition of a GWAS, the density of genetic markers and the extent of linkage disequilibrium should be sufficient to capture (by the r2 parameter) a large proportion of the common variation in the genome of the population under study, and the number of samples (in a case-control or trio design) should provide sufficient power to detect variants of modest effect. E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Notices]
[Pages 49289-49290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: FDA Cleared Pediatric 
Cancer Diagnostics and Prognostics

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(I), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the invention embodied in Patent 
Applications U.S. 10/133,937, filed 04/25/2002, entitled ``Methods for 
Analyzing High Dimensional Data for Classifying, Diagnosing, 
Prognosticating and/or Predicting Diseases and Other Biological 
States''; and U.S. 10/159,563, filed 05/31/2002, entitled ``Selections 
of Genes And Methods of Using The Same For Diagnosis And For Targeting 
The Therapy of Select Cancers''; to Althea Technologies, Inc. having a 
place of business in San Diego, California. The patent rights in this 
invention have been assigned to the United States of America (PHS ref 
E-324-2001/0,1).

DATE: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before October 
29, 2007 will be considered.

ADDRESS: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Cristina Thalhammer-Reyero, Ph.D., M.B.A., 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; e-mail: 
ThalhamC@mail.nih.gov; Telephone: 301-435-4507; Facsimile: 301-402-
0220.

SUPPLEMENTARY INFORMATION: The prospective exclusive license will be 
royalty bearing and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be 
granted unless, within 60 days from the date of this published Notice, 
NIH receives written evidence and argument that establishes that the 
grant of the license would not be consistent with the requirements of 
35 U.S.C. 209 and 37 CFR 404.7.
    The invention relates to a method of using supervised pattern 
recognition methods for classifying, diagnosing, predicting, or 
prognosticating various diseases. The method includes obtaining high 
dimensional experimental data, such as gene expression profiling data, 
filtering the data, reducing the dimensionality of the data through use 
of one or more methods, training artificial neural networks (ANN, a 
supervised pattern recognition method), ranking individual data points 
from the data, choosing multiple data points from the data based on the 
relative ranking, and using the multiple data points to determine if an 
unknown set of experimental data indicates a diseased condition, a 
predilection for a diseased condition, or a prognosis about a diseased 
condition. Further, the invention relates to sets of genes expressed in 
cancer cells that function to characterize each cancer type, and 
methods of using the sets of genes for diagnosis and for targeting the 
therapy of selected cancers. In particular, the methods apply to 
classify cancers which often present diagnostic dilemmas in clinical 
practice, such as the pediatric small round blue cell tumors (SRBCTs), 
including neuroblastoma (NB), rhabdomyosarcoma (RMS), Burkitt's 
lymphoma (BL), and the Ewing family of tumors (EWS). Specifically, the 
invention is an application of ANNs for

[[Page 49290]]

the diagnostic classification of cancers based on gene expression 
profiling data derived from cDNA microarrays. The ANNs were first 
trained to be used as models, and then correctly classified all samples 
tested and identified the genes most relevant to the classification. 
Their study demonstrated the potential applications of these methods 
for tumor diagnosis and for the identification of candidate targets for 
therapy. The uniqueness of this method is taking gene expression data 
generated by microarrays, minimizing the genes from the original 1000s 
to less than 100, identifying which genes are the most relevant to a 
classification, which gives an immediate clue to the actual biological 
processes involved, not just surrogate markers which have no bearing on 
the biology.
    The field of use may be limited to ``FDA Cleared Pediatric Cancer 
Diagnostics and Prognostics''.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection, and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: August 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-16930 Filed 8-27-07; 8:45 am]
BILLING CODE 4140-01-P

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