Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Gene Therapy and Cell-Based Therapy for Cardiac Arrhythmias, 26794-26795 [2013-10859]
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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7705, JOHNSONJ9@NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Mild
Cognitive Impairment.
Date: June 5, 2013.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: William Cruce, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7704, crucew@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: May 1, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–10854 Filed 5–7–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Use of Oligodeoxynucleotide
as Neuroprotectants in Cerebral and
Other Ischemic Injury
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
license to practice the inventions
embodied in U.S. provisional patent
application No. 60/176/115 (E–078–
2000/0–US–01) filed 1/14/2000; PCT
application No. PCT/US01/01122 (E–
078–2000/0–PCT–02) filed 1/12/2001;
U.S. patent No. 7,521,063 (E–078–2000/
1–US–01) filed 07/12/2002 and issued
04/21/2009; U.S. patent No. 7,919,477
(E–078–2000/1–US–02) filed 05/10/
2007and issued 04/05/2011; U.S. patent
No. 8,232,259 (E–078–2000/1–US–03)
filed 02/11/2011 and issued 07/31/2012;
E.U. patent No. 1322655 (E–078–2000/
0–EP–03) filed 1/12/2001 and issued 11/
14/2007 and validated in AT, GB, and
IE (E–078–2000/0–AT–05, E–078–2000/
0–GB–07, & E–078–2000/0–IE–08) and
issued 12/13/2007 as patent No.
6031430 and validated in Germany (E–
078–2000/0–DE–06); and E.U. patent
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:56 May 07, 2013
Jkt 229001
application No. 07021557.9 (E–078–
2000/0–EP–04) filed 11/05/2007; each
entitled ‘‘Oligodeoxynucleotide and Its
Use to Induce an Immune Response’’; by
Klinman et al. (FDA) to Oregon Health
Sciences University having a place of
business at 3181 SW. Sam Jackson Park
Rd. Portland, Oregon 97239. The patent
rights in this invention have been
assigned to the United States of
America.
DATES: Only written comments and/or
application for a license that are
received by the NIH Office of
Technology Transfer on or before June
7, 2013 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Tedd Fenn, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Email:
fennea@mail.nih.gov; Telephone: 301–
435–5031; Facsimile: 301–402–0220.
SUPPLEMENTARY INFORMATION: The
prospective worldwide 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,
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.
The subject patents relate to
compositions and methods of use of
oligodeoxynucleotides (ODNs)
expressing CpG motifs to induce
immune responses. These ODNs mimic
signals of invading pathogens. ODN
motifs trigger immune system responses
via Toll-like receptor 9 (TLR9). They
also mediate inflammatory responses to
tissue injury, such as those responses
following ischemic damage to the
central nervous system. Structural
differences between various ODNs may
stimulate distinct cell populations,
allowing selective targeting of immune
responses for therapeutic purposes.
Non-human primate and animal models
using specific ODNs for
pharmacological preconditioning have
shown that ODNs may act
therapeutically as neuroprotectants from
ischemic damage. These TLR ligands as
may be useful therapeutically as
neuroprotectants in cerebral ischemic
injury.
The field of use may be limited to
pharmacological preconditioning
against excitotoxic injury, ischemia and/
or hypoxia.
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Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response 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: May 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–10858 Filed 5–7–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up
Exclusive Evaluation Option License
Agreement: Gene Therapy and CellBased Therapy for Cardiac
Arrhythmias
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 a Start-Up
Exclusive Evaluation Option License
Agreement to Pace Biologics, LLC, a
company having a place of business in
Elkridge, Maryland, to practice the
inventions embodied in U.S. Provisional
Patent Application No. 61/180,491, filed
May 22, 2009 (HHS Ref. No. E–134–
2009/0–US–01), PCT Patent Application
No. PCT/US2010/035823, filed May 21,
2010 (HHS Ref. No. E–134–2009/0–
PCT–02), and U.S. Patent Application
No. 13/322,066, filed November 22,
2011 (HHS Ref. No. E–134–2009/0–US–
03), all entitled ‘‘Engineered Biological
Pacemakers.’’ The patent rights in these
inventions have been assigned to the
Government of the United States of
America. The territory of the
prospective Start-Up Exclusive
Evaluation Option License Agreement
may be worldwide, and the field of use
may be limited to ‘‘Gene therapy and
cell-based therapy for cardiac
arrhythmias in humans.’’
Upon the expiration or termination of
the Start-up Exclusive Evaluation
Option License Agreement, Pace
Biologics will have the exclusive right
to execute a Start-Up Exclusive Patent
SUMMARY:
E:\FR\FM\08MYN1.SGM
08MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices
License Agreement which will
supersede and replace the Start-up
Exclusive Evaluation Option License
Agreement, with no greater field of use
and territory than granted in the Startup Exclusive Evaluation Option License
Agreement.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before May
23, 2013 will be considered.
ADDRESSES: Requests for copies of the
patent application(s), inquiries,
comments and other materials relating
to the contemplated Start-Up Exclusive
Evaluation Option License Agreement
should be directed to: Tara L. Kirby,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4426; Facsimile: (301) 402–
0220; Email: tarak@mail.nih.gov. A
signed confidentiality nondisclosure
agreement will be required to receive
copies of any patent applications that
have not been published or issued by
the United States Patent and Trademark
Office or the World Intellectual Property
Organization.
SUPPLEMENTARY INFORMATION: This
invention consists of biological
pacemakers engineered to treat
arrhythmia by generating a normal heart
rhythm. These pacemakers include viral
vectors suitable for gene therapy that
incorporate Ca2+-activated adenylyl
cyclase, as well as cardiac cells or
cardiac-like cells derived from
embryonic stem cells or mesenchymal
stem cells, which are suitable for cellbased therapy.
In contrast to implantable artificial
pacemakers, these biological
pacemakers are not externally powered,
are not subject to interference from
other devices, and have a lower risk of
infection. They would be particularly
appropriate for patients who are not
candidates for artificial pacemakers,
such as children or those who have had
an implantable pacemaker removed due
to complications or other problems.
The prospective Start-Up Exclusive
Evaluation Option License Agreement is
being considered under the small
business initiative launched on October
1, 2011 and will comply with the terms
and conditions of 35 U.S.C. 209 and 37
CFR 404.7. The prospective Start-Up
Exclusive Evaluation Option License
Agreement and a subsequent Start-Up
Exclusive Patent License Agreement
may be granted unless the NIH receives
written evidence and argument, within
fifteen (15) days from the date of this
VerDate Mar<15>2010
17:56 May 07, 2013
Jkt 229001
published notice that establishes, that
the grant of the contemplated Start-Up
Exclusive Evaluation Option License
Agreement would not be consistent with
the requirements of 35 U.S.C. 209 and
37 CFR 404.7.
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 Start-Up Exclusive
Evaluation Option 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: May 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–10859 Filed 5–7–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Announcement of Requirements and
Registration for the National
Radiological and Nuclear Detection
Challenge
Domestic Nuclear Detection
Office, DHS.
ACTION: Notice.
AGENCY:
DNDO announces the
National Radiological and Nuclear
Detection (Rad/Nuc) Challenge, a
participation challenge being conducted
under the America Competes
Reauthorization Act, for state, local, and
tribal law enforcement, other first
responders, public safety officials, and
Civil Support Team members.
DATES: The Rad/Nuc Challenge will be
held from August 20 through August 22,
2013.
ADDRESSES: The Rad/Nuc Challenge will
be hosted at the I.G. Brown Air National
Guard Training and Education Center,
Alcoa, Tennessee, near Knoxville.
FOR FURTHER INFORMATION CONTACT:
Timothy Smith, (202) 254–7297,
Radnucchallenge@hq.dhs.gov. To
register for and find additional
information about the Rad/Nuc
challenge, visit https://
www.radnucchallenge.org.
SUPPLEMENTARY INFORMATION:
SUMMARY:
General
The Department of Homeland
Security (DHS), Domestic Nuclear
Detection Office (DNDO), announces the
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26795
National Radiological and Nuclear
Detection (Rad/Nuc) Challenge, a
participation challenge authorized
under 15 U.S.C. 3719(c)(3), for state,
local, and tribal law enforcement, other
first responders, public safety officials,
and Civil Support Team members. The
purpose of the Rad/Nuc Challenge is to
increase proficiency, improve Concepts
of Operations, and promote proper use
of Radiation and Nuclear Detection
(RND) equipment by state and local
agencies in support of the domestic
RND mission to prevent the illicit use
and/or movement of radioactive
materials within the United States.
The Rad/Nuc Challenge will consist
of a competitive RND search exercise
held over a three-day period. The
competition is designed to develop and
recognize enhanced RND search skills,
train on the use of various pieces of
RND equipment, and influence vendors
and developers to adapt and improve
RND equipment capability and
suitability for field use.
The event will be hosted at the I.G.
Brown Air National Guard Training and
Education Center located in Alcoa,
Tennessee, near Knoxville. Equipment
specific and RND search refresher
training will be provided for all
competitors on the first day of the event
prior to the start of the competition.
I. Subject of Challenge Competition
The purpose of the Rad/Nuc
Challenge is to further DNDO’s vision of
a Nation ready to detect and interdict
terrorist radiological and/or nuclear
threats by the effective and efficient
integration of capabilities and resources
of the Global Nuclear Detection
Architecture (GNDA). Specifically, the
Rad/Nuc Challenge will serve to
coordinate implementation of the
domestic portion of the GNDA,
strengthen its operational relationships,
and improve detection capabilities
across the GNDA. The Rad/Nuc
Challenge will provide a mechanism to
improve radiation detection capabilities
of Federal, state, local, and tribal
stakeholders through competitive
exercise, increased awareness and
cooperation, and first-hand interaction
with RND equipment vendors and
developers. The Rad/Nuc Challenge will
exploit the proven success and costeffectiveness of trade shows and
challenge competitions to advance
capabilities in the RND field.
The Rad/Nuc Challenge is an RND
proficiency competition. Even though it
is designed to incorporate specific RND
job skills or tasks, it may be necessary
to deviate from, or be innovative in the
application of, certain existing protocols
and procedures in order to obtain the
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26794-26795]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10859]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation Option License
Agreement: Gene Therapy and Cell-Based Therapy for Cardiac Arrhythmias
AGENCY: National Institutes of Health, 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 a Start-Up
Exclusive Evaluation Option License Agreement to Pace Biologics, LLC, a
company having a place of business in Elkridge, Maryland, to practice
the inventions embodied in U.S. Provisional Patent Application No. 61/
180,491, filed May 22, 2009 (HHS Ref. No. E-134-2009/0-US-01), PCT
Patent Application No. PCT/US2010/035823, filed May 21, 2010 (HHS Ref.
No. E-134-2009/0-PCT-02), and U.S. Patent Application No. 13/322,066,
filed November 22, 2011 (HHS Ref. No. E-134-2009/0-US-03), all entitled
``Engineered Biological Pacemakers.'' The patent rights in these
inventions have been assigned to the Government of the United States of
America. The territory of the prospective Start-Up Exclusive Evaluation
Option License Agreement may be worldwide, and the field of use may be
limited to ``Gene therapy and cell-based therapy for cardiac
arrhythmias in humans.''
Upon the expiration or termination of the Start-up Exclusive
Evaluation Option License Agreement, Pace Biologics will have the
exclusive right to execute a Start-Up Exclusive Patent
[[Page 26795]]
License Agreement which will supersede and replace the Start-up
Exclusive Evaluation Option License Agreement, with no greater field of
use and territory than granted in the Start-up Exclusive Evaluation
Option License Agreement.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before May
23, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application(s), inquiries,
comments and other materials relating to the contemplated Start-Up
Exclusive Evaluation Option License Agreement should be directed to:
Tara L. Kirby, Ph.D., Senior Licensing and Patenting Manager, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
4426; Facsimile: (301) 402-0220; Email: tarak@mail.nih.gov. A signed
confidentiality nondisclosure agreement will be required to receive
copies of any patent applications that have not been published or
issued by the United States Patent and Trademark Office or the World
Intellectual Property Organization.
SUPPLEMENTARY INFORMATION: This invention consists of biological
pacemakers engineered to treat arrhythmia by generating a normal heart
rhythm. These pacemakers include viral vectors suitable for gene
therapy that incorporate Ca\2+\-activated adenylyl cyclase, as well as
cardiac cells or cardiac-like cells derived from embryonic stem cells
or mesenchymal stem cells, which are suitable for cell-based therapy.
In contrast to implantable artificial pacemakers, these biological
pacemakers are not externally powered, are not subject to interference
from other devices, and have a lower risk of infection. They would be
particularly appropriate for patients who are not candidates for
artificial pacemakers, such as children or those who have had an
implantable pacemaker removed due to complications or other problems.
The prospective Start-Up Exclusive Evaluation Option License
Agreement is being considered under the small business initiative
launched on October 1, 2011 and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective Start-Up
Exclusive Evaluation Option License Agreement and a subsequent Start-Up
Exclusive Patent License Agreement may be granted unless the NIH
receives written evidence and argument, within fifteen (15) days from
the date of this published notice that establishes, that the grant of
the contemplated Start-Up Exclusive Evaluation Option License Agreement
would not be consistent with the requirements of 35 U.S.C. 209 and 37
CFR 404.7.
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 Start-Up Exclusive Evaluation Option
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: May 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-10859 Filed 5-7-13; 8:45 am]
BILLING CODE 4140-01-P
