[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Notices]
[Pages 42504-42505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17497]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of a 
Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions

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, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in PCT 
Patent Application No. PCT/US2005/12289, U.S. Patent No. 7,901,881, 
U.S. Patent Application No. 13/024,845 and foreign equivalents thereof 
entitled ``Diagnostic Tool for Diagnosing Benign Versus Malignant 
Thyroid Lesions'' (HHS Ref. No. E-124-2004/0,1,2) and PCT Patent 
Application No. PCT/US2008/010139 and U.S. Patent Application No. 12/
675,209 entitled ``Diagnostic Tool for Diagnosing Benign Versus 
Malignant Thyroid Lesions'' (HHS Ref. No. E-326-2007/0) to Veracyte, 
Inc., which is located in San Francisco, California. The patent rights 
in these inventions have been assigned to the United States of America.
    Other than license applications submitted as objections to this 
Notice of Intent to Grant an Exclusive License, no further license 
applications will be considered for the exclusive field of use set 
forth below if Veracyte, Inc. is granted an exclusive license pursuant 
to this Notice of Intent to Grant an Exclusive License. The prospective 
exclusive license territory may be worldwide and the field of use may 
be limited to the use of Licensed Patent Rights for the diagnosis and 
prognosis of thyroid 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 20, 2012 will be considered, in addition to the current non-
exclusive applications under consideration, for the prospective license 
territory and field of use to be granted under the contemplated 
exclusive patent license.

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: This technology is based on the discovery of 
differentially expressed thyroid (DET) genes and their encoded proteins 
whose expression levels can be correlated to benign or malignant states 
in a thyroid cell. Specifically, this data arose from a microarray 
analysis of genes expressed in the eight subtypes of thyroid tumors 
that are typically difficult to diagnose by cytology of fine needle 
aspiration (FNA) biopsies. Analysis of the (DET) genes led to the 
development of 6 gene and 10 gene models that distinguish benign vs. 
malignant papillary thyroid tumors. Subsequently, a 72 gene model has 
been developed for diagnosing less common forms of thyroid cancer such 
as follicular carcinoma. These results provide a molecular 
classification system for thyroid tumors and this in turn provides a 
more accurate diagnostic tool for the clinician managing patients with 
suspicious thyroid lesions. In addition to diagnostics, this invention 
can be used in the staging of thyroid malignancies by measuring changes 
in DET gene and protein expression relative to reference cells. 
Finally, this invention can also be used in the discovery of 
therapeutic agents through the detection in changes of DET gene and 
protein levels prior to and after treatment.
    The prospective exclusive license and any further license 
applications received as objections to this Notice of Intent to Grant 
an 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 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 404.7.
    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.

[[Page 42505]]

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 13, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-17497 Filed 7-18-12; 8:45 am]
BILLING CODE 4140-01-P