[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40119-40120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16268]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Evaluation Option Exclusive License: 
Development of a Diagnostic and Prognostic for Breast and Prostate 
Cancer Using Spatial Genome Organization

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404, that the National Institutes of Health, Department of Health and 
Human Services, is contemplating the grant of an exclusive evaluation 
option license to practice the inventions embodied in U.S. Provisional 
Application 61/094,318 filed September 4, 2008 entitled ``Method for 
detection of cancer based on spatial genome organization'' (HHS Ref No. 
E-283-2008/0-US-01); International Application PCT/US2009/055857 filed 
September 3, 2009 entitled ``Method for detection of cancer based on 
spatial genome organization'' (HHS Ref No. E-283-2008/0-PCT-02); U.S. 
Patent Application 13/062,247 filed March 4, 2011 entitled ``Method for 
detection of cancer based on spatial genome organization'' (HHS Ref No. 
E-283-2008/0-US-0; and foreign equivalents thereof to Radial Genomics, 
Ltd. (``RG''), a company located in Cambridge, U.K. The patent rights 
in these inventions have been assigned to the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide and the field of use may be limited to the use of the 
Licensed Patent Rights for the diagnosis, prognosis, and prediction of 
cancer.
    Upon the expiration or termination of the exclusive evaluation 
option license, RG will have the exclusive right to execute an 
exclusive commercialization license which will supersede and replace 
the exclusive evaluation option license with no greater field of use 
and territory than granted in the exclusive evaluation option license.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
28, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Whitney A. Hastings, Ph.D., Licensing 
and Patenting Manager, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301) 402-0220; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: The successful treatment of cancer is 
correlated with the early detection of the cancerous cells. 
Conventional cancer diagnosis is largely based on qualitative 
morphological criteria, but more accurate quantitative tests could 
greatly increase early detection of malignant cells. It has been 
observed that the spatial arrangement of DNA in the nucleus is altered 
in cancer cells in comparison to normal cells. Therefore, it is 
possible to distinguish malignant cells by mapping the position of 
labeled marker genes in the nucleus. This NIH invention provides 
methods of detecting abnormal cells in a sample using the spatial 
position of one or more genes within the nucleus of a cell, as well as 
a kit for detecting abnormal cells using such methods. It also provides 
methods of identifying gene markers for abnormal cells using the 
spatial position of one or more genes within the nucleus of a cell. 
Therefore, this invention could be used as a very effective cancer 
diagnostic from tumor biopsies after non-invasive techniques such as a 
mammogram or PSA assay have suggested cancer.
    The primary product arising from this technology would be a 
diagnostic for cancer using tumor biopsies after non-invasive 
techniques such as a mammogram or PSA assay have suggested the presence 
of cancer. This novel in vitro diagnostic test for cancer has use in 
oncology laboratories of hospitals and commercial clinical 
laboratories. It has several advantages

[[Page 40120]]

over other diagnostics including sensitive cancer detection, small 
sample size (100-200 cells), probes to all genomic regions are 
available, and it does not require mitotic chromosomes. Additionally, 
it is applicable to both solid tumors and blood cancers, allows 
analysis of subpopulations from biopsy, measures metastatic potential 
of cancer cells, determines tumor type, and can be alternative to or 
complementary to conventional diagnostics.
    The prospective exclusive evaluation option license, and a 
subsequent exclusive commercialization license, may be granted unless 
the 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 part 404 within fifteen (15) days from the 
date of this published notice.
    Complete applications for a license in the field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive evaluation option license. Comments and 
objections submitted 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: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16268 Filed 7-10-14; 8:45 am]
BILLING CODE 4140-01-P