Government-Owned Inventions; Availability for Licensing, 42527-42528 [2013-16947]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 136 / Tuesday, July 16, 2013 / Notices
(2) the withdrawal of ‘‘Compliance
Policy Guide Sec. 690.700 Salmonella
Contamination of Dry Dog Food.’’ The
enforcement policy in the CPG
supersedes the policies articulated in 21
CFR 500.35 and CPG Sec. 690.700.
II. Comments
Interested persons may submit either
electronic comments regarding the CPG
to https://www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the CPG at either https://
www.fda.gov/ora/compliance_ref/cpg/
default.htm or at https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
CPG.
Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16975 Filed 7–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:49 Jul 15, 2013
Jkt 229001
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of patent
applications.
Islet Beta Cell Only M3 Muscarinic
Acetylcholine Receptor Knockout
Mouse
Description of Technology:
Researchers at NIH have developed islet
beta cell M3 muscarinic acetylcholine
receptor knockout mouse. The mice
were generated by crossing floxed
mouse M3 muscarinic acetylcholine
receptor mice with mice in which Cre
recombinase was controlled by the betacell specific rat insulin promoter (RIPCre mice).
Potential Commercial Applications:
Study of the physiological role of betacell M3 muscarinic receptors in the
regulation of glucose homeostasis and
insulin release in vivo.
Competitive Advantages: Allows for
study of the role of the M3 receptors in
the pancreas without whole body effects
confounding the results.
Development Stage: In vivo data
available (animal)
¨
Inventor: Jurgen Wess, Ph.D. (NIDDK)
Publication: Gautam D, et al. A
critical role for beta cell M3 muscarinic
acetylcholine receptors in regulating
insulin release and blood glucose
homeostasis in vivo. Cell Metab. 2006
Jun;3(6):449–61. [PMID 16753580]
Intellectual Property: HHS Reference
No. E–452–2013/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Jaime M. Greene,
M.S.; 301–435–5559;
greenejaime@mail.nih.gov.
Transgenic Mice With Constitutively
Active M3 Muscarinic Receptor in Islet
Beta Cells
Description of Technology: Q490L
point mutation was introduced into the
rat M3 muscarinic receptor cDNA to
confer persistent, constitutive (ligandindependent) activity. Expression of the
M3 receptor mutant was placed under
the control of a 650 bp fragment of the
rat insulin promoter II (RIP II) to limit
expression to the islet beta cell.
Potential Commercial Applications:
Diabetes research, especially type II
Diabetes.
Competitive Advantages: Beneficial
metabolic effects of this mouse model
include high basal insulin secretion,
improved glucose tolerance, increased
serum insulin, and resistance to high-fat
diet-induced glucose intolerance and
hyperglycemia.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
42527
Development Stage: In vivo data
available (animal)
¨
Inventor: Jurgen Wess, Ph.D. (NIDDK)
Publication: Gautam D, et al.
Beneficial metabolic effects caused by
persistent activation of beta-cell M3
muscarinic acetylcholine receptors in
transgenic mice. Endocrinology. 2010
Nov;151(11):5185–94. [PMID 20843999]
Intellectual Property: HHS Reference
No. E–453–2013/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Jaime M. Greene,
M.S.; 301–435–5559;
greenejaime@mail.nih.gov.
Transgenic Mice Overexpressing Islet
Beta Cell M3 Muscarinic Acetylcholine
Receptors
Description of Technology:
Researchers at NIH have generated
transgenic mice in which the M3
muscarinic receptor is overexpressed in
pancreatic beta cells. This was done by
placing the receptor gene under the
control of the 650 bp rat insulin
promoter II (RIP II). The resulting mice
show a pronounced increase in glucose
tolerance and enhanced plasma insulin
levels. Strikingly, these mutant mice
were resistant to diet-induced glucose
intolerance and hyperglycemia.
Potential Commercial Applications:
Diabetes research, especially type II
Diabetes.
Competitive Advantages: These
transgenic mice overexpress the M3
muscarinic acetylcholine receptor only
in pancreatic beta cells but notably are
resistant to diet-induced glucose
intolerance and hyperglycemia.
Development Stage: In vivo data
available (animal).
¨
Inventor: Jurgen Wess, Ph.D. (NIDDK).
Publication: Gautam D, et al. A
critical role for beta cell M3 muscarinic
acetylcholine receptors in regulating
insulin release and blood glucose
homeostasis in vivo. Cell Metab. 2006
Jun;3(6):449–61. [PMID 16753580].
Intellectual Property: HHS Reference
No. E–455–2013/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Jaime M. Greene,
M.S.; 301–435–5559;
greenejaime@mail.nih.gov.
An Improved System for Production of
Recombinant Baculovirus
Description of Technology:
Baculoviruses have been used for
decades to produce proteins in insect
cell hosts. Current systems for
generating recombinant baculovirus
have several shortcomings which
prevent their easy use in highthroughput applications. The present
E:\FR\FM\16JYN1.SGM
16JYN1
42528
Federal Register / Vol. 78, No. 136 / Tuesday, July 16, 2013 / Notices
invention discloses an improved system
to quickly and efficiently generate
recombinant baculoviruses which
produce recombinant proteins. In the
new system, the baculovirus transfer
vector, transposition helper plasmid and
E. coli strain carrying the bacmid DNA
were modified to eliminate the need for
screening positive clones and improve
the efficiency of baculovirus
production. Taken together, these
improvements permit facile highthroughput recombinant baculovirus
production at reduced cost and
improved speed over the currently
available systems.
Potential Commercial Applications:
• High-throughput protein
production
• Generation of virus-like particles in
insect cells
Competitive Advantages:
• Elimination of background plasmid
DNA during recombinant baculovirus
production
• Elimination of nonproductive
transposition events leading to false
positives
• Lower cost production of
baculovirus
• Increased speed of baculovirus
production (allowing high-throughput
production with limited screening)
• Higher efficiency cloning of
baculovirus constructs
Development Stage:
• Prototype
• Pilot
• In vitro data available
Inventor: Dominic Esposito (NCI).
Intellectual Property: HHS Reference
No. E–287–2012/0—Research Tool.
Patent protection is not being pursued
for this technology.
Related Technology: HHS Reference
No. E–164–2011—Combinatorial
Cloning Platform.
Licensing Contact: Susan Ano, Ph.D.;
301–435–5515; anos@mail.nih.gov.
Dated: July 9, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–16947 Filed 7–15–13; 8:45 am]
BILLING CODE 4140–01–P
emcdonald on DSK67QTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Alternative Medicine; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Mar<15>2010
18:49 Jul 15, 2013
Jkt 229001
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Complementary and Alternative Medicine
Special Emphasis Panel RFA–AT–11–011:
Mechanistic Research on CAM Natural
Products (R01).
Date: September 13, 2013.
Time: 7:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Martina Schmidt, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Complementary
& Alternative Medicine, NIH, 6707
Democracy Blvd., Suite 401, Bethesda, MD
20892, 301–594–3456,
schmidma@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: July 10, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–16940 Filed 7–15–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Risk, Prevention and Health
Behavior.
Date: July 24, 2013.
Time: 10:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Kristen Prentice, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3112,
MSC 7808, Bethesda, MD 20892, 301–496–
0726, prenticekj@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 10, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–16939 Filed 7–15–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; EUREKA.
Date: August 14, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave. NW., Washington, DC 20037.
Contact Person: Natalia Strunnikova,
Ph.D., Scientific Review Officer, Scientific
E:\FR\FM\16JYN1.SGM
16JYN1
]]>Agencies
[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Notices]
[Pages 42527-42528]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16947]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious
commercialization of results of federally-funded research and
development. Foreign patent applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the U.S. patent applications listed below may be obtained by writing to
the indicated licensing contact at the Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to
receive copies of patent applications.
Islet Beta Cell Only M3 Muscarinic Acetylcholine Receptor Knockout
Mouse
Description of Technology: Researchers at NIH have developed islet
beta cell M3 muscarinic acetylcholine receptor knockout mouse. The mice
were generated by crossing floxed mouse M3 muscarinic acetylcholine
receptor mice with mice in which Cre recombinase was controlled by the
beta-cell specific rat insulin promoter (RIP-Cre mice).
Potential Commercial Applications: Study of the physiological role
of beta-cell M3 muscarinic receptors in the regulation of glucose
homeostasis and insulin release in vivo.
Competitive Advantages: Allows for study of the role of the M3
receptors in the pancreas without whole body effects confounding the
results.
Development Stage: In vivo data available (animal)
Inventor: J[uuml]rgen Wess, Ph.D. (NIDDK)
Publication: Gautam D, et al. A critical role for beta cell M3
muscarinic acetylcholine receptors in regulating insulin release and
blood glucose homeostasis in vivo. Cell Metab. 2006 Jun;3(6):449-61.
[PMID 16753580]
Intellectual Property: HHS Reference No. E-452-2013/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
greenejaime@mail.nih.gov.
Transgenic Mice With Constitutively Active M3 Muscarinic Receptor in
Islet Beta Cells
Description of Technology: Q490L point mutation was introduced into
the rat M3 muscarinic receptor cDNA to confer persistent, constitutive
(ligand-independent) activity. Expression of the M3 receptor mutant was
placed under the control of a 650 bp fragment of the rat insulin
promoter II (RIP II) to limit expression to the islet beta cell.
Potential Commercial Applications: Diabetes research, especially
type II Diabetes.
Competitive Advantages: Beneficial metabolic effects of this mouse
model include high basal insulin secretion, improved glucose tolerance,
increased serum insulin, and resistance to high-fat diet-induced
glucose intolerance and hyperglycemia.
Development Stage: In vivo data available (animal)
Inventor: J[uuml]rgen Wess, Ph.D. (NIDDK)
Publication: Gautam D, et al. Beneficial metabolic effects caused
by persistent activation of beta-cell M3 muscarinic acetylcholine
receptors in transgenic mice. Endocrinology. 2010 Nov;151(11):5185-94.
[PMID 20843999]
Intellectual Property: HHS Reference No. E-453-2013/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
greenejaime@mail.nih.gov.
Transgenic Mice Overexpressing Islet Beta Cell M3 Muscarinic
Acetylcholine Receptors
Description of Technology: Researchers at NIH have generated
transgenic mice in which the M3 muscarinic receptor is overexpressed in
pancreatic beta cells. This was done by placing the receptor gene under
the control of the 650 bp rat insulin promoter II (RIP II). The
resulting mice show a pronounced increase in glucose tolerance and
enhanced plasma insulin levels. Strikingly, these mutant mice were
resistant to diet-induced glucose intolerance and hyperglycemia.
Potential Commercial Applications: Diabetes research, especially
type II Diabetes.
Competitive Advantages: These transgenic mice overexpress the M3
muscarinic acetylcholine receptor only in pancreatic beta cells but
notably are resistant to diet-induced glucose intolerance and
hyperglycemia.
Development Stage: In vivo data available (animal).
Inventor: J[uuml]rgen Wess, Ph.D. (NIDDK).
Publication: Gautam D, et al. A critical role for beta cell M3
muscarinic acetylcholine receptors in regulating insulin release and
blood glucose homeostasis in vivo. Cell Metab. 2006 Jun;3(6):449-61.
[PMID 16753580].
Intellectual Property: HHS Reference No. E-455-2013/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
greenejaime@mail.nih.gov.
An Improved System for Production of Recombinant Baculovirus
Description of Technology: Baculoviruses have been used for decades
to produce proteins in insect cell hosts. Current systems for
generating recombinant baculovirus have several shortcomings which
prevent their easy use in high-throughput applications. The present
[[Page 42528]]
invention discloses an improved system to quickly and efficiently
generate recombinant baculoviruses which produce recombinant proteins.
In the new system, the baculovirus transfer vector, transposition
helper plasmid and E. coli strain carrying the bacmid DNA were modified
to eliminate the need for screening positive clones and improve the
efficiency of baculovirus production. Taken together, these
improvements permit facile high-throughput recombinant baculovirus
production at reduced cost and improved speed over the currently
available systems.
Potential Commercial Applications:
High-throughput protein production
Generation of virus-like particles in insect cells
Competitive Advantages:
Elimination of background plasmid DNA during recombinant
baculovirus production
Elimination of nonproductive transposition events leading
to false positives
Lower cost production of baculovirus
Increased speed of baculovirus production (allowing high-
throughput production with limited screening)
Higher efficiency cloning of baculovirus constructs
Development Stage:
Prototype
Pilot
In vitro data available
Inventor: Dominic Esposito (NCI).
Intellectual Property: HHS Reference No. E-287-2012/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technology: HHS Reference No. E-164-2011--Combinatorial
Cloning Platform.
Licensing Contact: Susan Ano, Ph.D.; 301-435-5515;
anos@mail.nih.gov.
Dated: July 9, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-16947 Filed 7-15-13; 8:45 am]
BILLING CODE 4140-01-P
