Government-Owned Inventions; Availability for Licensing, 71930-71931 [E7-24529]
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Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Notices
the device(s) that would be addressed
by a declaration of conformity.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VI. Electronic Access
National Institutes of Health
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. CDRH maintains a site on the
Internet for easy access to information
including text, graphics, and files that
you may download to a personal
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Updated on a regular basis, the CDRH
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Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 019’’ will be available on the
CDRH home page. You may access the
CDRH home page at https://www.fda.gov/
cdrh.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ through the hyperlink at
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This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
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Government-Owned Inventions;
Availability for Licensing
VII. Submission of Comments and
Effective Date
mstockstill on PROD1PC66 with NOTICES
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) written or
electronic comments regarding this
document. Two copies of any mailed
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that individuals may submit one paper
copy. Comments are to be identified
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modifications to the list of recognized
standards, Recognition List Number:
019. These modifications to the list or
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publication of this notice in the Federal
Register.
Dated: December 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24580 Filed 12–18–07; 8:45 am]
BILLING CODE 4160–01–S
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National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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. 207 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.
ADDRESSES: 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 the
patent applications.
Aquaporin 2 Polyclonal Antibodies
Description of Technology:
Aquaporins, also known as water
channels, form pores in cell membranes
and selectively transport water in and
out of the cell. Aquaporins are involved
in regulation of water balance and blood
pressure, and thirteen different isoforms
have been found in mammals.
Aquaporin 2 (AQP2) is located in the
collecting duct of the kidney, and is
regulated by the peptide hormone
vasopressin. AQP2 expression is
increased in conditions where there is
water retention, such as pregnancy and
congestive heart failure, and mutations
of AQP2 are associated with
nephrogenic diabetes insipidus. Also,
lithium treatment, often administered
for bipolar disorder, can cause acquired
diabetes insipidus by decreasing AQP2
expression.
The inventors have developed rabbit
polyclonal antibodies directed against a
peptide sequence in the C-terminal
region of AQP2
(LKGLEPDTDWEEREVRRRQ). The
sequence is upstream of
phosphorylation sites in this region, and
consequently the antibodies recognize
both unphosphorylated and
phosphorylated AQP2. The sequence is
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identical in human, rat, mouse, cow,
and sheep.
Applications: Western blotting,
immunohistochemistry, and
immunoprecipitation.
Inventor: Mark A. Knepper (NHLBI).
Related Publication: SR DiGiovanni, S
Nielsen, EI Christensen, MA Knepper.
Regulation of collecting duct water
channel expression by vasopressin in
Brattleboro rat. Proc Natl Acad Sci U S
A. 1994 Sep 13;91(19):8984–8988.
Patent Status: HHS Reference No. E–
045–2008/0—Research Tool. Patent
prosecution is not being pursued for this
technology.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Tara L. Kirby, PhD;
301/435–4426; tarak@mail.nih.gov.
Treatment for Chronic Inflammatory
Disease and Cancer by Inhibition of
MMP–1
Description of Technology: The
breakdown of connective tissue is a
feature of many pathological diseases,
including tumors as well as
inflammatory diseases such as
atherosclerosis, rheumatoid arthritis,
and periodontitis. Proteases involved in
connective tissue turnover, such as
matrix metalloproteinases (MMPs) and
the plasminogen activation system, have
been shown to play a pivotal role in
inflammatory disease and in tumor cell
invasion, growth and metastasis. Matrix
metalloproteinase-1 (MMP–1), a
collagenase, is expressed in areas of
rapid remodeling of the extracellular
matrix in both normal and pathological
conditions.
The inventors have determined that
the serine protease plasmin stimulates
MMP–1 production in monocytes
through binding to the annexin A2
heterotetramer. The inventors have also
determined that inactive plasmin is an
inhibitor of plasmin induction of MMP–
1. The invention discloses new methods
of suppressing inflammation and tumors
through inhibition of plasmin activity,
for example by using agents, including
inactive plasmin, to inhibit plasminstimulated MMP–1 production.
Applications: Therapeutics for
inflammatory disease and tumor
suppression.
Market: In the United States,
approximately two percent of the
population have atherosclerosis, more
than five percent have an autoimmune
inflammatory disease, and
approximately fifty percent of all adults
over thirty have periodontitis.
Development Status: Early stage.
Inventors: Yahong Zhang and Larry
M. Wahl (NIDCR).
E:\FR\FM\19DEN1.SGM
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Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Notices
mstockstill on PROD1PC66 with NOTICES
Related Publication: Y Zhang, ZH
Zhou, TH Bugge, LM Wahl. Urokinasetype plasminogen activator stimulation
of monocyte matrix metalloproteinase-1
production is mediated by plasmindependent signaling through annexin
A2 and inhibited by inactive plasmin. J
Immunol. 2007 Sep 1;179(5):3297–3304.
Patent Status: U.S. Provisional
Application No. 60/980,009 filed 15 Oct
2007 (HHS Reference No. E–168–2007/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Tara Kirby, PhD;
301/435–4426; tarak@mail.nih.gov.
Establishment of Two Cell Lines That
Stably Express Luciferase for In Vivo
Tracking
Description of Technology: Available
for licensing are two renal carcinoma
cell lines, 786-O(luc) and 786-O/VHL/
(luc) which both stably express
luciferase. 786-O(luc) lacks von HippelLandau (VHL) protein expression and it
has constitutively high expression of
hypoxia-inducible transcription factor2alpha (HIF–2alpha). The second stably
expresses VHL, a tumor suppressor, and
has minimal HIF–2alpha expression.
These cell lines can be tracked in vivo
and can be used to study VHLdependent and HIF–2alpha-dependent
events such as tumorigenesis. VHL
mutations lead to the clinical
manifestations of von Hippel-Lindau
disease, a rare autosomal dominant
syndrome characterized by abnormal
growth of blood vessels in multiple
organs, including the brain and kidneys.
Applications: Model to study VHL
pathology.
Advantages: Cell lines that stably
express luciferase for in vivo tracking.
Benefits: Easy, ready to use positive
and negative VHL and HIF–2alpha cells
that stably express luciferase for in vivo
tests.
Market: Incidence of VHL syndrome
is 1 in 38,951; HCC is the third leading
cause of cancer death worldwide; HCC
is the fifth most common cancer in the
world; Post-operative five year survival
rate of HCC patients is 30–40%.
Inventor: Leonard M. Neckers,
Marston Linehan (NCI).
Patent Status: HHS Reference No. E–
005–2007/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for nonexclusive licensing.
Licensing Contact: Jennifer Wong;
301/435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute (Urologic
Oncology Branch) is seeking statements
of capability or interest from parties
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21:40 Dec 18, 2007
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interested in collaborative research to
develop further uses for these two cell
lines that stably express luciferase for in
vivo tracking. Please contact John D.
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
HIV gp41-Membrane Proximal Region
Arrayed on Hepatitis B Surface Antigen
Particles for HIV Diagnostic and
Vaccine Applications
Description of Invention: This
technology describes vectors encoding
the membrane proximal region (MPR)
and select variants from HIV–1 gp41
linked to the hepatitis B surface antigen
(HBsAg) and the resulting expressed
particles for use in HIV diagnostic and
vaccine applications. HIV–1 gp41
membrane proximal region contains two
epitopes recognized by broadly
neutralizing human monoclonal
antibodies 2F5 and 4E10. However,
immunization with gp41 MPR or the
2F5 or 4E10 epitopes have failed to raise
neutralizing antibodies. In the subject
technology, the particles were shown to
bind antibodies from broadly
neutralizing human sera and to the two
known broadly neutralizing antibodies
2F5 and 4E10 with high relative
affinities, demonstrating that the
relevant epitopes are accessible for
antibody binding and the potential
utility of the particles in diagnostic
applications. Additionally, these
particles could be used to screen phagedisplay libraries for novel broadly crossreactive neutralizing antibodies, of
which only five are currently known.
These particles could also be used for
selection of MPR specific B cells. Lastly,
these particles have been shown to be
immunogenic and raise antibodies that
recognize HIV–1 Env gp160 expressed
on the cell surface. These immunogens
can elicit neutralizing antibodies
specific for HIV gp41 MPR, the MPR of
gp41 is highly conserved across various
HIV clades and therefore is likely to
generate broadly neutralizing antibodies
when administered in a proper
presentation in a lipid context as is the
case in HBsAg particles. Multiple copies
of the MPR of HIV–1 gp41 arrayed on
the particles could significantly increase
the immunogenic potential compared to
monomeric molecules. An increase of
this nature has been observed with
HBsAg and HPV virus-like particles in
hepatitis B and cervical cancer vaccines,
respectively, suggesting that particulate
array may improve the presentation of
selected epitopes to the immune system.
Applications: HIV vaccines; HIV
diagnostics.
Advantages: These immunogens can
elicit neutralizing antibodies specific for
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71931
HIV gp41 MPR, which is highly
conserved across various HIV clades
and therefore is likely to generate
broadly neutralizing antibodies when
administered in a proper presentation in
a lipid context as is the case in HBsAg
particles. Multiple copies of the MPR of
HIV–1 gp41 arrayed on the particles
could significantly increase the
immunogenic potential compared to
monomeric molecules.
Inventors: Richard T. Wyatt (NIAID),
Sanjay K. Phogat (NIAID), Ira Berkower
(FDA).
Patent Status: U.S. Provisional
Application No. 60/653,930 filed 18 Feb
2005 (HHS Reference No. E–123–2005/
0–US–01); PCT Application No. PCT/
US2006/005613 filed 17 Feb 2006,
which published as WO 2006/112929
on 30 Nov 2006 (HHS Reference No. E–
123–2005/1–PCT–01); U.S. Patent
Application No. 11/816,069 filed 10
Aug 2007 (HHS Reference No. E–123–
2005/1–US–02).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Susan Ano, Ph.D.;
301/435–5515; anos@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID Vaccine Research Center
Structural Virology Section is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize HIV–1 MPR regions
coupled with the hepatitis B surface
antigen particles. Please contact Richard
Wyatt, Ph.D. at richardwyatt@nih.gov
for more information.
Dated: December 11, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–24529 Filed 12–18–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[Federal Register Volume 72, Number 243 (Wednesday, December 19, 2007)]
[Notices]
[Pages 71930-71931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24529]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, 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. 207 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.
ADDRESSES: 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 the patent applications.
Aquaporin 2 Polyclonal Antibodies
Description of Technology: Aquaporins, also known as water
channels, form pores in cell membranes and selectively transport water
in and out of the cell. Aquaporins are involved in regulation of water
balance and blood pressure, and thirteen different isoforms have been
found in mammals. Aquaporin 2 (AQP2) is located in the collecting duct
of the kidney, and is regulated by the peptide hormone vasopressin.
AQP2 expression is increased in conditions where there is water
retention, such as pregnancy and congestive heart failure, and
mutations of AQP2 are associated with nephrogenic diabetes insipidus.
Also, lithium treatment, often administered for bipolar disorder, can
cause acquired diabetes insipidus by decreasing AQP2 expression.
The inventors have developed rabbit polyclonal antibodies directed
against a peptide sequence in the C-terminal region of AQP2
(LKGLEPDTDWEEREVRRRQ). The sequence is upstream of phosphorylation
sites in this region, and consequently the antibodies recognize both
unphosphorylated and phosphorylated AQP2. The sequence is identical in
human, rat, mouse, cow, and sheep.
Applications: Western blotting, immunohistochemistry, and
immunoprecipitation.
Inventor: Mark A. Knepper (NHLBI).
Related Publication: SR DiGiovanni, S Nielsen, EI Christensen, MA
Knepper. Regulation of collecting duct water channel expression by
vasopressin in Brattleboro rat. Proc Natl Acad Sci U S A. 1994 Sep
13;91(19):8984-8988.
Patent Status: HHS Reference No. E-045-2008/0--Research Tool.
Patent prosecution is not being pursued for this technology.
Licensing Status: This technology is available as a research tool
under a Biological Materials License.
Licensing Contact: Tara L. Kirby, PhD; 301/435-4426;
tarak@mail.nih.gov.
Treatment for Chronic Inflammatory Disease and Cancer by Inhibition of
MMP-1
Description of Technology: The breakdown of connective tissue is a
feature of many pathological diseases, including tumors as well as
inflammatory diseases such as atherosclerosis, rheumatoid arthritis,
and periodontitis. Proteases involved in connective tissue turnover,
such as matrix metalloproteinases (MMPs) and the plasminogen activation
system, have been shown to play a pivotal role in inflammatory disease
and in tumor cell invasion, growth and metastasis. Matrix
metalloproteinase-1 (MMP-1), a collagenase, is expressed in areas of
rapid remodeling of the extracellular matrix in both normal and
pathological conditions.
The inventors have determined that the serine protease plasmin
stimulates MMP-1 production in monocytes through binding to the annexin
A2 heterotetramer. The inventors have also determined that inactive
plasmin is an inhibitor of plasmin induction of MMP-1. The invention
discloses new methods of suppressing inflammation and tumors through
inhibition of plasmin activity, for example by using agents, including
inactive plasmin, to inhibit plasmin-stimulated MMP-1 production.
Applications: Therapeutics for inflammatory disease and tumor
suppression.
Market: In the United States, approximately two percent of the
population have atherosclerosis, more than five percent have an
autoimmune inflammatory disease, and approximately fifty percent of all
adults over thirty have periodontitis.
Development Status: Early stage.
Inventors: Yahong Zhang and Larry M. Wahl (NIDCR).
[[Page 71931]]
Related Publication: Y Zhang, ZH Zhou, TH Bugge, LM Wahl.
Urokinase-type plasminogen activator stimulation of monocyte matrix
metalloproteinase-1 production is mediated by plasmin-dependent
signaling through annexin A2 and inhibited by inactive plasmin. J
Immunol. 2007 Sep 1;179(5):3297-3304.
Patent Status: U.S. Provisional Application No. 60/980,009 filed 15
Oct 2007 (HHS Reference No. E-168-2007/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Tara Kirby, PhD; 301/435-4426;
tarak@mail.nih.gov.
Establishment of Two Cell Lines That Stably Express Luciferase for In
Vivo Tracking
Description of Technology: Available for licensing are two renal
carcinoma cell lines, 786-O(luc) and 786-O/VHL/(luc) which both stably
express luciferase. 786-O(luc) lacks von Hippel-Landau (VHL) protein
expression and it has constitutively high expression of hypoxia-
inducible transcription factor-2alpha (HIF-2alpha). The second stably
expresses VHL, a tumor suppressor, and has minimal HIF-2alpha
expression. These cell lines can be tracked in vivo and can be used to
study VHL-dependent and HIF-2alpha-dependent events such as
tumorigenesis. VHL mutations lead to the clinical manifestations of von
Hippel-Lindau disease, a rare autosomal dominant syndrome characterized
by abnormal growth of blood vessels in multiple organs, including the
brain and kidneys.
Applications: Model to study VHL pathology.
Advantages: Cell lines that stably express luciferase for in vivo
tracking.
Benefits: Easy, ready to use positive and negative VHL and HIF-
2alpha cells that stably express luciferase for in vivo tests.
Market: Incidence of VHL syndrome is 1 in 38,951; HCC is the third
leading cause of cancer death worldwide; HCC is the fifth most common
cancer in the world; Post-operative five year survival rate of HCC
patients is 30-40%.
Inventor: Leonard M. Neckers, Marston Linehan (NCI).
Patent Status: HHS Reference No. E-005-2007/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for non-exclusive licensing.
Licensing Contact: Jennifer Wong; 301/435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
(Urologic Oncology Branch) is seeking statements of capability or
interest from parties interested in collaborative research to develop
further uses for these two cell lines that stably express luciferase
for in vivo tracking. Please contact John D. Hewes, PhD at 301-435-3121
or hewesj@mail.nih.gov for more information.
HIV gp41-Membrane Proximal Region Arrayed on Hepatitis B Surface
Antigen Particles for HIV Diagnostic and Vaccine Applications
Description of Invention: This technology describes vectors
encoding the membrane proximal region (MPR) and select variants from
HIV-1 gp41 linked to the hepatitis B surface antigen (HBsAg) and the
resulting expressed particles for use in HIV diagnostic and vaccine
applications. HIV-1 gp41 membrane proximal region contains two epitopes
recognized by broadly neutralizing human monoclonal antibodies 2F5 and
4E10. However, immunization with gp41 MPR or the 2F5 or 4E10 epitopes
have failed to raise neutralizing antibodies. In the subject
technology, the particles were shown to bind antibodies from broadly
neutralizing human sera and to the two known broadly neutralizing
antibodies 2F5 and 4E10 with high relative affinities, demonstrating
that the relevant epitopes are accessible for antibody binding and the
potential utility of the particles in diagnostic applications.
Additionally, these particles could be used to screen phage-display
libraries for novel broadly cross-reactive neutralizing antibodies, of
which only five are currently known. These particles could also be used
for selection of MPR specific B cells. Lastly, these particles have
been shown to be immunogenic and raise antibodies that recognize HIV-1
Env gp160 expressed on the cell surface. These immunogens can elicit
neutralizing antibodies specific for HIV gp41 MPR, the MPR of gp41 is
highly conserved across various HIV clades and therefore is likely to
generate broadly neutralizing antibodies when administered in a proper
presentation in a lipid context as is the case in HBsAg particles.
Multiple copies of the MPR of HIV-1 gp41 arrayed on the particles could
significantly increase the immunogenic potential compared to monomeric
molecules. An increase of this nature has been observed with HBsAg and
HPV virus-like particles in hepatitis B and cervical cancer vaccines,
respectively, suggesting that particulate array may improve the
presentation of selected epitopes to the immune system.
Applications: HIV vaccines; HIV diagnostics.
Advantages: These immunogens can elicit neutralizing antibodies
specific for HIV gp41 MPR, which is highly conserved across various HIV
clades and therefore is likely to generate broadly neutralizing
antibodies when administered in a proper presentation in a lipid
context as is the case in HBsAg particles. Multiple copies of the MPR
of HIV-1 gp41 arrayed on the particles could significantly increase the
immunogenic potential compared to monomeric molecules.
Inventors: Richard T. Wyatt (NIAID), Sanjay K. Phogat (NIAID), Ira
Berkower (FDA).
Patent Status: U.S. Provisional Application No. 60/653,930 filed 18
Feb 2005 (HHS Reference No. E-123-2005/0-US-01); PCT Application No.
PCT/US2006/005613 filed 17 Feb 2006, which published as WO 2006/112929
on 30 Nov 2006 (HHS Reference No. E-123-2005/1-PCT-01); U.S. Patent
Application No. 11/816,069 filed 10 Aug 2007 (HHS Reference No. E-123-
2005/1-US-02).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Susan Ano, Ph.D.; 301/435-5515;
anos@mail.nih.gov.
Collaborative Research Opportunity: The NIAID Vaccine Research
Center Structural Virology Section is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate, or commercialize HIV-1 MPR regions coupled
with the hepatitis B surface antigen particles. Please contact Richard
Wyatt, Ph.D. at richardwyatt@nih.gov for more information.
Dated: December 11, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-24529 Filed 12-18-07; 8:45 am]
BILLING CODE 4140-01-P
