[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Page 40120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Molecular-
Based Cancer Diagnostic and Prognostic

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 patent 
license to Heragen, Inc., which is located in Benicia, California to 
practice the inventions embodied in the following patent applications:

    1. U.S. Provisional Application 61/152,597 filed February 13, 
2009 entitled ``Molecular-Based Method of Cancer Diagnosis and 
Prognosis'' (HHS Ref No. E-023-2009/0-US-01).
    2. International Application PCT/US2010/024026 filed February 
12, 2010 entitled ``Molecular-Based Method of Cancer Diagnosis and 
Prognosis'' (HHS Ref No. E-023-2009/0-PCT-02).
    3. U.S. Patent No. 8,715,928 issued May 6, 2014 entitled 
``Molecular-Based Method of Cancer Diagnosis and Prognosis'' (HHS 
Ref No. E-023-2009/0-US-03).
    4. U.S. Patent Application No. 14/215,574, filed March 17, 2014 
entitled ``Molecular-Based Method of Cancer Diagnosis and 
Prognosis'' (HHS Ref No. E-023-2009/0-US-04).

    The patent rights in these inventions have been assigned to the 
United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of the Licensed Patent 
Rights to develop FDA approved and/or 510K cleared tests and kits for 
the diagnosis and prognosis of breast and lung cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 11, 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: Molecular profiling with high throughput 
assays has gained utility in the management of select cancer patients 
and several gene expression-based assays are now marketed for improved 
prognostic accuracy for patients with cancer.
    This technology describes a genomics based diagnostic assay for the 
diagnosis and prognosis of cancer patients. Using a mouse model of 
breast cancer, the inventors identified a gene expression signature 
that can predict the outcome for human breast cancer patients with as 
few as six genes. The gene signature includes a total of 79 cancer 
survival factor-associated genes and was validated using available 
genomic test sets that were based on previously conducted human 
clinical trials. More recently, the six-gene-model was validated for 
cancers other than breast using multiple, independent, publicly-
available human lung cancer data sets. In addition to predicting the 
outcome of cancer patients, this technology could also be used to 
stratify patients for further therapy and treat patients by 
administering therapeutic agents that alter the activity of one of the 
aforementioned cancer survival factor-associated genes.
    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 part 
404. The prospective exclusive license may be granted unless within 
thirty (30) days from the date of this published notice, 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.
    Any additional 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 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. 2014-16266 Filed 7-10-14; 8:45 am]
BILLING CODE 4140-01-P