[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