Prospective Grant of Exclusive License: The Development of Theranostic Kits for mTOR Analog-based Chemotherapy, 15218 [2015-06487]
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15218
Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
letter, which finds Licensee’s kit to be a
medical device substantially equivalent to
one or more similar legally marketed devices,
and states that the Licensee’s device can be
marketed in the U.S. (i.e., 510(k) cleared),
such test kit to be distributed in commerce
for the purpose of predicting survival,
response to therapy, or cancer recurrence in
breast cancer patients.’’
Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06498 Filed 3–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of
Theranostic Kits for mTOR Analogbased Chemotherapy
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant to
ProVivoX, Inc., of an exclusive
evaluation option license to practice the
inventions embodied in the following
US Patent, US Patent Application, and
International Patent Application (and all
foreign counterparts): US Provisional
Patent Application Serial No. 61/
144,501, filed 14 January 2009, entitled:
‘‘Ratio-based Biomarker of Survival
Utilizing PTEN and Phospho-AKT’’
[HHS Reference No. E–025–2009/0–US–
01]; International Application No. PCT/
US2010/020944, filed on 13 January
2010, entitled: ‘‘Ratio-based Biomarkers
and Methods of Use Thereof’’ [HHS
Reference No. E–025–2009/0–PCT–02];
US Patent Application Serial No. 13/
144,474, filed 13 July 2011 [HHS
Reference No. E–025–2009/0–US–02];
and Canadian Patent Application No.
2,749,601, filed on 13 January 2010
[HHS Reference No. E–025–2009/0–CA–
05]. The patent rights in this invention
have been assigned to the Government
of the United States of America.
The prospective exclusive evaluation
option license territory may be United
States and Canada, and the field of use
may be limited to:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
a. ‘‘Exclusive use of the Licensed Patent
Rights to develop an immunohistochemistry
(IHC)- or tissue microarray-based test kit for
use with human tissue samples and approved
in the United States and Canada as a Class
III medical device, such test kit to be
distributed in commerce for the for the
purpose of predicting survival, response to
therapy, or cancer recurrence in breast cancer
patients.’’
b. ‘‘Non-exclusive use of the Licensed
Patent Rights to develop an
immunohistochemistry (IHC)- or tissue
microarray-based test kit for use with human
tissue samples and for which the United
States FDA issues an order, in the form of a
VerDate Sep<11>2014
16:51 Mar 20, 2015
Jkt 235001
Upon the expiration or termination of
the exclusive evaluation option license,
ProVivoX, Inc., 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 or
applications for a license (or both)
which are received by the NIH Office of
Technology Transfer on or before April
7, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive evaluation
option license should be directed to:
Patrick McCue, 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) 435–5560; Facsimile:
(301) 402–0220; Email: mccuepat@
mail.nih.gov.
The
technology describes a method of
identifying cancer patients that may
benefit from mTOR analog-based
chemotherapy or agents directed against
the AKT pathway.
The prospective exclusive evaluation
license is being considered under the
small business initiative launched on 1
October 2011, and will comply with the
terms and conditions of 35 U.S.C. 209
and 37 CFR part 404. 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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Freedom of Information Act, 5 U.S.C.
552.
Dated: March 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–06487 Filed 3–20–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Prevalence,
Incidence, Epidemiology and
Molecular Variants of HIV in Blood
Donors in Brazil (NHLBI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the FR in
Volume 79 on December 31, 2014 on
page 78876 and allowed 60-days for
public comment. One public comment
was received that was a personal
opinion regarding conducting research
about the Brazil blood donation system.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments To Omb: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: Desk Officer for NIH.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Simone Glynn, MD, Project
Officer/ICD Contact, Two Rockledge
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Page 15218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of
Theranostic Kits for mTOR Analog-based Chemotherapy
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant to ProVivoX, Inc., of an
exclusive evaluation option license to practice the inventions embodied
in the following US Patent, US Patent Application, and International
Patent Application (and all foreign counterparts): US Provisional
Patent Application Serial No. 61/144,501, filed 14 January 2009,
entitled: ``Ratio-based Biomarker of Survival Utilizing PTEN and
Phospho-AKT'' [HHS Reference No. E-025-2009/0-US-01]; International
Application No. PCT/US2010/020944, filed on 13 January 2010, entitled:
``Ratio-based Biomarkers and Methods of Use Thereof'' [HHS Reference
No. E-025-2009/0-PCT-02]; US Patent Application Serial No. 13/144,474,
filed 13 July 2011 [HHS Reference No. E-025-2009/0-US-02]; and Canadian
Patent Application No. 2,749,601, filed on 13 January 2010 [HHS
Reference No. E-025-2009/0-CA-05]. The patent rights in this invention
have been assigned to the Government of the United States of America.
The prospective exclusive evaluation option license territory may
be United States and Canada, and the field of use may be limited to:
a. ``Exclusive use of the Licensed Patent Rights to develop an
immunohistochemistry (IHC)- or tissue microarray-based test kit for
use with human tissue samples and approved in the United States and
Canada as a Class III medical device, such test kit to be
distributed in commerce for the for the purpose of predicting
survival, response to therapy, or cancer recurrence in breast cancer
patients.''
b. ``Non-exclusive use of the Licensed Patent Rights to develop
an immunohistochemistry (IHC)- or tissue microarray-based test kit
for use with human tissue samples and for which the United States
FDA issues an order, in the form of a letter, which finds Licensee's
kit to be a medical device substantially equivalent to one or more
similar legally marketed devices, and states that the Licensee's
device can be marketed in the U.S. (i.e., 510(k) cleared), such test
kit to be distributed in commerce for the purpose of predicting
survival, response to therapy, or cancer recurrence in breast cancer
patients.''
Upon the expiration or termination of the exclusive evaluation
option license, ProVivoX, Inc., 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 or applications for a license (or both)
which are received by the NIH Office of Technology Transfer on or
before April 7, 2015 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
evaluation option license should be directed to: Patrick McCue, 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) 435-5560; Facsimile: (301)
402-0220; Email: mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The technology describes a method of
identifying cancer patients that may benefit from mTOR analog-based
chemotherapy or agents directed against the AKT pathway.
The prospective exclusive evaluation license is being considered
under the small business initiative launched on 1 October 2011, and
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR
part 404. 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: March 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-06487 Filed 3-20-15; 8:45 am]
BILLING CODE 4140-01-P
