[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41970-41971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18668]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Apparatus for 
Microarray Binding Sensors Having Biological Probe Materials Using 
Carbon Nanotube Transistors

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Commercialization Patent 
License to practice the inventions embodied in the Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to Nanobernetics, LLC (``Nanobernetics'') located in Maryland.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before September 20, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Jaime M. Greene, Senior Licensing 
and Patenting Manager, NCI Technology Transfer Center, 9609 Medical 
Center Drive, Rm. 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business 
mail), Rockville, MD 20850-9702 Telephone: (240)-276-5530;

[[Page 41971]]

Facsimile: (240)-276-5504 Email: <a href="/cdn-cgi/l/email-protection#b3d4c1d6d6ddd6d9d2daded6f3ded2dadf9ddddadb9dd4dcc5"><span class="__cf_email__" data-cfemail="385f4a5d5d565d525951555d785559515416565150165f574e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    EP Patent 1999277 (Application No. 07753436.0) filed 19 March 
2007, titled ``Apparatus for biosensor microarrays based on carbon 
nanotube transistors having biological probe materials, method for 
its production and method of electronically detecting a biological 
target material'', validated in FR, DE, IE, and GB, HHS Reference 
No.: E-056-2007/0-EP-04;
    Australia Patent 2007227415 (Application No. 2007227415) filed 
10/16/08, titled ``Apparatus for microarray binding sensors having 
biological probe materials using carbon nanotube transistors'', HHS 
Reference No.: E-056-2007/0-AU-05;
    Canada Patent 2646465 (Application No. 2646465) filed 03/19/07, 
titled ``Apparatus for microarray binding sensors having biological 
probe materials using carbon nanotube transistors'', HHS Reference 
No.: E-056-2007/0-CA-06;
    Japan Patent 5048752 (Application No. 2009-501490) filed 03/19/
07, titled ``Apparatus for microarray binding sensors having 
biological probe materials using carbon nanotube transistors'', HHS 
Reference No.: E-056-2007/0-JP-07;
    EP Patent 2570490 (Application No. 12160369.0) filed 03/19/07, 
titled ``Apparatus for microarray binding sensors having biological 
probe materials using carbon nanotube transistors'', validated in 
FR, DE, and GB. HHS Reference No.: E-056-2007/0-EP-08;
    U.S. Patent 8,017,938 (Application No. 11/723,369), filed 19 
March 2007, titled ``Apparatus for Microarray Binding Sensors Having 
Biological Probe Materials Using Carbon Nanotube Transistors'', HHS 
Ref. No.: E-056-2007/0-US-03; and
    PCT Application No. PCT/US2007/06809, filed 19 March 2007, now 
abandoned, titled ``Apparatus for Microarray Binding Sensors Having 
Biological Probe Materials Using Carbon Nanotube Transistors'', HHS 
Ref. No.: E-056-2007/0-PCT-02.
    U.S. Provisional Patent Application No. 60/743,524, filed 17 
March 2006, now abandoned, titled ``Apparatus for Microarray DNA 
Binding Sensors Using Carbon Nanotube Transistors'', HHS Ref. No.: 
E-056-2007/0-US-01.

    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to: ``The development of an FDA-
approved or cleared in vitro diagnostic for the detection of 
hematological malignancies, wherein nucleic acids encoding one or more 
of the following genes are detected: (1) BCR-ABL, (2) FLT3, (3) Btk, 
(4) Alk, (5) Bcl-2, (6) Akt, and (7) PI3K.''
    This technology discloses a microarray apparatus that uses carbon 
nanotubes transistors and electronic circuitry to quantitatively 
measure changes in gene expression levels. Typically, microarrays are 
microscope glass slides spotted with thousands of different genes. The 
array does not have built-in reader, and the detection is performed 
using a fluorescence scanner after hybridization with fluorescent-
tagged target DNA. For simple nucleic acid detection, current methods 
rely upon various combinations of enzymatic amplification of nucleic 
acids and fluorescent labeling of targets, which entail enzymatic 
manipulation of the nucleic acid being tested and chemical labeling, 
respectively. These methods are both time consuming and afford limited 
sensitivity. In cases where microarray technology is used as a tool for 
monitoring gene expression patterns and profiling of micro RNA (miRNA) 
in normal and cancerous tissue, quantification of changes has typically 
been optically-based. While this technique is highly sensitive, use of 
optical methods impedes progress in both system miniaturization and in 
direct interfacing with data collection electronics.
    To overcome the limitation of current microarray technologies, the 
inventors have developed a highly sensitive microarray apparatus that 
uses carbon nanotube transistors for the electronic detection of 
biological probe-target binding. The present invention provides an 
apparatus for biological target material detection which uses an array 
of carbon nanotube transistors, with each being operated as a field 
effect transistor. A single carbon nanotube transistor is associated 
with a distinct biological probe material. The current versus voltage 
characteristics or transconductance between the source and drain 
electrodes is measured before and after a binding event between the 
biological probe and target materials. By using a mathematical 
relationship, the exact amount of target binding can be extracted. 
Importantly, the present apparatus offers a significant advantage in 
simplicity of protocol as the method used therewith does not require 
chemical or enzymatic manipulation of the target being detected.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Commercialization Patent 
License Agreement. 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: August 25, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-18668 Filed 9-1-17; 8:45 am]
 BILLING CODE 4140-01-P


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