Government-Owned Inventions; Availability for Licensing, 29332-29334 [05-10064]
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29332
Federal Register / Vol. 70, No. 97 / Friday, May 20, 2005 / Notices
on NIDA’s evaluation of the
information, capacities, and plans
provided by potential Collaborator(s).
NIDA follows stepwise development
processes and procedures common to
the medications development paradigm,
i.e., a candidate compound must
successfully complete each necessary
pre-requisite step prior to being
advanced for further testing and
development. It is NIDA’s intention to
provide, assuming pre-requisite
preclinical and clinical safety,
preclinical and clinical trials services
sufficient to permit the completion of
Phase II hypothesis testing trials for
cocaine and methamphetamine
dependence indications. Assuming
demonstration and review of safety and
efficacy at the conclusion of Phase II
trials and subject to negotiation, NIDA
will consider undertaking Phase III
trials sufficient to permit Collaborator to
seek a U.S. New Drug Application
(NDA).
Please note that a CRADA is not a
funding mechanism. No NIH funding
may be provided to a Collaborator under
a CRADA. All assistance is provided
‘‘in-kind’’. Therefore the Collaborator
will bear the financial and
organizational costs of meeting its share
of obligations under any Research Plan
that may be negotiated in connection
with the CRADA.
‘‘Cooperative Research and
Development Agreement’’ or ‘‘CRADA’’
means the anticipated joint agreement to
be entered into by NIDA pursuant to the
Federal Technology Transfer Act of
1986 and Executive Order 12591 of
October 10, 1987 to collaborate on the
specific research project described
below.
The National Institute on Drug Abuse
seeks an agreement with a
pharmaceutical or biotechnology
company for joint research,
development, evaluation, and potential
commercialization of vigabatrin for the
treatment of cocaine and
methamphetamine dependence.
The CRADA aims include the rapid
publication of research results and the
timely exploitation of commercial
opportunities. The CRADA partner will
enjoy rights of first negotiation for
licensing Government rights to any
inventions arising under the agreement
and will advance funds payable upon
signing the CRADA to help defray
Government expenses for patenting
such inventions and other CRADArelated costs.
The expected duration of the CRADA
will be 3 to 5 years.
Selection criteria for choosing the
CRADA partner will include but not be
limited to:
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1. Ability to collaborate with NIDA on
further research and development of
this technology in Phase I and Phase II
clinical studies. All such studies will
occur in the United States and under
FDA IND rules. Demonstration of
experience and expertise in this or
related areas of technology and the
ability to provide intellectual
contribution to the ongoing research and
development. Ability to accomplish
objectives according to an appropriate
timetable to be outlined in the
Collaborator’s proposal. At an absolute
minimum, Collaborator must be able to
provide vigabatrin and placebo
sufficient to complete all clinical and
preclinical studies required in the
Research Plan.
2. Demonstration of the resources
(facilities, personnel and expertise)
necessary to perform research,
development and commercialization of
this technology.
3. Commitment of reasonable effort
and resources on research, development
and commercialization of this
technology.
4. Expertise in the commercial
development, production, marketing
and sales of products related to this area
of technology .
5. The level of financial support, if
any, the Collaborator will supply for
CRADA-related Government activities.
6. A willingness to cooperate with the
National Institute on Drug Abuse in the
publication of research results.
7. An agreement to be bound by the
DHHS rules involving human subjects,
patent rights and ethical treatment of
animals.
8. A willingness to accept the legal
provisions and language of the CRADA
with only minor modifications (if any).
9. Provisions for equitable
distribution of patent rights to any
inventions made during the course of
the subject CRADA research. Generally,
the rights of ownership are retained by
the organization which is the employer
of the inventor, with (1) an irrevocable,
nonexclusive, royalty-free license to the
Government (when a company
employee is the sole inventor) or (2) an
option to negotiate an exclusive or
nonexclusive license to the company on
terms that are appropriate (when a
Government employee is an inventor).
Dated: May 11, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–10066 Filed 5–19–05; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
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.
Synthesis of Phosphocholine Ester
Derivatives and Conjugates Thereof
Louis J. Rezanka (NIA), U.S. Provisional
Application No. 60/623,762 filed 29
Oct 2004 (DHHS Reference No. E–
330–2004/0–US–01)
Licensing Contact: Michael
Shmilovich; (301) 435–5019;
shmilovm@mail.nih.gov.
Available for licensing and
commercial development is a method of
synthesizing EPC (4-Nitrophenyl-6-(Ophosphocholine) hydroxyhexanoate)
and methods of synthesizing
phosphocholine analogues and the
phosphocholine conjugates formed
therefrom. These molecules have
clinical and research applications as
anti-microbial agents. Specifically, EPC
conjugated to protein carriers has been
demonstrated to generate a protective
immune response to Streptococcus
pneumoniae. The invention provides a
process for EPC synthesis as well as for
its reaction intermediates for use in
synthesis.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
E:\FR\FM\20MYN1.SGM
20MYN1
Federal Register / Vol. 70, No. 97 / Friday, May 20, 2005 / Notices
Methods and Compositions for the ex
vivo High-Throughput Detection of
Protein/Protein Interactions
Sankar Adhya and Amos Oppenheim
(NCI), U.S. Provisional Application
No. 60/629,933 filed 23 Nov 2004
(DHHS Reference No. E–264–2004/0–
US–01)
Licensing Contact: Cristina
Thalhammer-Reyero; (301) 435–4507;
thalhamc@mail.nih.gov.
This invention relates to methods and
compositions for the high-throughput
detection of protein-protein interactions
using a lambda phage display system.
One of the central challenges in systems
biology is defining the interactome, or
set of all protein-protein interactions
within a living cell, as a basis for
understanding biological processes for
early diagnosis of disease and for drug
development. The invention provides a
novel proteomic toolbox for highthroughput medical research based in
combining phage lambda protein
display and recent advances in
manipulation of the phage’s genome.
The method uses the bacteriophage
lambda vector to express proteins on its
surface, and is based on the use of
mutant phage vectors such that only
interacting phages will be able to
reproduce and co-infect an otherwise
non-permissive host and produce
plaques. The invention allows for the
characterization of bacteriophage
display libraries that could be easily
adapted to be used in large-scale
functional protein chip assays.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Coacervate Microparticles Useful for
the Sustained Release Administration
of Therapeutics Agents
Phillip Heller (NIA), U.S. Provisional
Application No. 60/602,651 filed 19
Aug 2004 (DHHS Reference No. E–
116–2004/0–US–01)
Licensing Contact: Susan O. Ano;
(301) 435–5515; anos@mail.nih.gov.
The described technology is a
biodegradable microbead or
microparticle, useful for the sustained
localized delivery of biologically active
proteins or other molecules of
pharmaceutical interest. The
microbeads are produced from several
USP grade materials, a cationic polymer,
an anionic polymer and a binding
component (e.g., gelatin, chondroitin
sulfate and avidin), in predetermined
ratios.) Biologically active proteins are
incorporated into preformed microbeads
VerDate jul<14>2003
20:07 May 19, 2005
Jkt 205001
via an introduced binding moiety under
nondenaturing conditions.
Proteins or other biologically active
molecules are easily denatured, and
once introduced into the body, rapidly
cleared. These problems are
circumvented by first incorporating the
protein into the microbead. Microbeads
with protein payloads are then
introduced into the tissue of interest,
where the microbeads remain while
degrading into biologically innocuous
materials while delivering the protein/
drug payload for adjustable periods of
time ranging from hours to weeks. This
technology is an improvement of the
microbead technology described in U.S.
Patent No. 5,759,582.
This technology has two commercial
applications. The first is a
pharmaceutical drug delivery
application. The bead allows the
incorporated protein or drug to be
delivered locally at high concentration,
ensuring that therapeutic levels are
reached at the target site while reducing
side effects by keeping systemic
concentration low. The microbead
accomplishes this while protecting the
biologically active protein from harsh
conditions traditionally encountered
during microbead formation/drug
formulation.
The microbeads are inert,
biodegradable, and allow a sustained
release or multiple-release profile of
treatment with various active agents
without major side effects. In addition,
the bead maintains functionality under
physiological conditions.
Second, the microbeads and
microparticles can be used in various
research assays, such as isolation and
separation assays, to bind target proteins
from biological samples. A disadvantage
of the conventional methods is that the
proteins become denatured. The
denaturation results in incorrect binding
studies or inappropriate binding
complexes being formed. The instant
technology corrects this disadvantage by
using a bead created in a more neutral
pH environment. It is this same
environment that is used for the binding
of the protein of interest as well.
Lepirudin Adsorbed to Catheter
McDonald Horne (CC), U.S. Provisional
Application No. 60/436,439 filed 23
Dec 2002 (DHHS Reference No. E–
295–2002/0–US–01); PCT Application
No. PCT/US03/40888 filed 22 Dec
2003, which published as WO 2004/
058324 A2 on 15 Jul 2004 (DHHS
Reference No. E–295–2002/0–PCT–
02)
Licensing Contact: Michael
Shmilovich; (301) 435–5018;
shmilovm@mail.nih.gov.
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29333
The invention is a method for
preventing venous access device (VAD)
thrombosis by coating the VAD catheter
with lepirudin, which has been found to
be readily adsorbed by the silicone
rubber of the VADs, and is expected to
have good retention properties. VADs
typically remain in place for weeks or
months and sometimes cause clotting
(thrombosis) of the veins. Accordingly,
the simple technique of soaking a
silicone catheter in lepirudin before
venous insertion is the gist of the
invention. Chronically ill patients who
must be catheterized for long periods of
time will benefit particularly from this
technique which promises to reduce
swelling and pain associated with VADinduced thrombosis.
Reference: Horne, MK, Brokaw, KJ.
Antithrombin activity of lepirudin
adsorbed to silicone
(polydimethylsiloxane) tubing.
Thrombosis Research 2003; 112:111–
115.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
VAC–BAC Shuttle Vector System
Bernard Moss, Arban Domi (NIAID),
U.S. Provisional Application No. 60/
371,840 filed 10 Apr 2002 (DHHS
Reference No. E–355–2001/0–US–01);
U.S. Provisional Application No. 60/
402,824 filed 09 Aug 2002 (DHHS
Reference No. E–355–2001/1–US–01);
International Patent Application No.
PCT/US03/11183 filed 10 Apr 2003,
which published as WO 03/087330
A2 on 23 Oct 2003 (DHHS Reference
No. E–355–2001/2–PCT–01); U.S.
Patent Application No. 10/959,392
filed 05 Oct 2004 (DHHS Reference
No. E–355–2001/2–US–02); European
Patent Application No. 037183431
filed 10 Apr 2003 (DHHS Reference
No. E–355–2001/2–EP–03)
Licensing Contact: Robert M. Joynes;
(301) 594–6565; joynesr@mail.nih.gov.
This invention relates to a VAC–BAC
shuttle vector system for the creation of
recombinant poxviruses from DNA
cloned in a bacterial artificial
chromosome. A VAC–BAC is a bacterial
artificial chromosome (BAC) containing
a vaccinia virus genome (VAC) that can
replicate in bacteria and produce
infectious virus in mammalian cells.
The following are some of the uses for
a VAC–BAC:
1. VAC–BACs can be used to modify
vaccinia virus DNA by deletion,
insertion or point mutation or add new
DNA to the VAC genome with methods
developed for bacterial plasmids, rather
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29334
Federal Register / Vol. 70, No. 97 / Friday, May 20, 2005 / Notices
than by recombination in mammalian
cells.
2. It can be used to produce
recombinant vaccinia viruses for gene
expression.
3. It can be used for the production of
modified vaccinia viruses that have
improved safety or immunogenicity.
Advantages of the VAC–BAC shuttle
system:
1. VAC–BACs are clonally purified
from bacterial colonies before virus
reconstitution in mammalian cells.
2. Manipulation of DNA is much
simpler and faster in bacteria than in
mammalian cells.
3. Modified genomes can be
characterized prior to virus
reconstitution.
4. Only virus with modified genomes
will be produced so that virus plaque
isolations are not needed.
5. Generation of a stock of virus from
a VAC–BAC is accomplished within a
week rather than many weeks.
6. Multiple viruses can be generated
at the same time since plaque
purification is unnecessary.
References:
1. Domi, A., and B. Moss. 2002.
Cloning the vaccinia virus genome as a
bacterial artificial chromosome in
Escherichia coli and recovery of
infectious virus in mammalian cells.
Proc. Natl. Acad. Sci. USA 99:12415–
12420.
2. Domi, A., and B. Moss. 2005.
Engineering of a vaccinia virus bacterial
artificial chromosome in Escherichia
coli by bacteriophage lambda-based
recombination. Nature Methods 2:95–
97.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Dated: May 12, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–10064 Filed 5–19–05; 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, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
VerDate jul<14>2003
20:07 May 19, 2005
Jkt 205001
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.
DU145 Camptothecin (CPT)-Resistant
Cell Line
Dr. Yves Pommier (NCI)
DHHS Reference No. E–159–2005/0—
Research Tool
Licensing Contact: John Stansberry; 301/
435–5236; stansbej@mail.nih.gov
Drug resistance is a major limitation
of chemotherapy. Understanding how
drug resistance develops may lead to
more effective treatments. This
invention describes the DU145
Camptothecin (CPT)-resistant prostate
cancer cell line that can be used to
study mechanisms of drug resistance.
For more details see Pommier et al.,
Cancer Research 61, 1964–1969, March
1, 2001.
Mammary Gland Differentiation by 2Methoxyestradiol
Jeffrey E. Green et al. (NCI)
DHHS Ref. No. E–069–2005/0–US–01
Licensing Contact: Thomas P. Clouse;
301/435–4076; clouset@mail.nih.gov
This invention is based on the
discovery that administration of 2Methoxyestradiol (2-ME2) to female
mice at various developmental stages
will result in the differentiation of
mammary epithelial cells to form
rudimentary alveolar structures and to
produce milk proteins. This effect has
also been demonstrated in an in vitro
experimental system. Since 2-ME2 is
highly expressed during late stages of
human pregnancy and pregnancy is
known to reduce the risk of human
bresat cancer, possibly due to
differentiating effects on the mammary
gland, 2ME2 may be developed into a
preventive agent against breast cancer in
women. Additionally, 2-ME2 may be
useful in augmenting mammary gland
differentiation and milk production
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under circumstances where normal
differentiation is compromised.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Methods for Detecting Progression of
Low Grade Cervical Dysplasia
Thomas Ried et al. (NCI)
DHHS Reference No. E–041–2005/0–
US–01
Licensing Contact: Thomas P. Clouse;
301/435–4076; clouset@mail.nih.gov
This invention describes a test that
can be applied to Pap smears to
differentiate low-grade dysplastic
lesions that are likely to progress to
higher-grade dysplasia and cervical
cancer from those that are likely to
regress. The differentiating factor is the
presence of genetic gain on the long arm
of chromosome 3. The inventors have
shown that low grade Pap smears that
progress already exhibit extra copies of
3q, while those that do not show the 3q
gain spontaneously regress.
Around 10–15% of the 3 million Pap
smears with low-grade dysplasia each
year in the United States progress to
higher grade lesions. Currently, HPV
testing is used to stratify these low grade
disease Pap smears, but as the majority
of these Pap smears are already HPV
infected, the test has very low
specificity. The instant 3q test, which
targets the human telomerase gene,
TERC, is a significant improvement in
sensitivity and specificity over the
current methods used for the detection
of progressing versus regressing lesions.
Antibodies to Rheb, a Ras-Related
Protein
Geoffrey J. Clark and Michele Vos (NCI)
DHHS Reference No. E–351–2004—
Research Tool.
Licensing Contact: Mojdeh Bahar; 301/
435–2950; baharm@mail.nih.gov
The invention relates to polyclonal
antibodies that recognize the protein
Rheb, a key player in protein
biosynthesis. Rheb is a small GTPbinding protein that is structurally
related to the oncoprotein Ras, but Rheb
does not activate the same pathways as
Ras. Instead, Rheb binds to the tumor
suppressor TSC2 (Tuberin) and causes
activation of the S6 kinase in a TOR
(Target of Rapamycin) dependent
manner. Rheb likely plays roles in the
response to insulin and the
development of human tumors. Thus,
the antibodies could provide useful
reagents to investigate the functions of
Rheb in these and other biological
processes.
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Notices]
[Pages 29332-29334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, DHHS.
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.
Synthesis of Phosphocholine Ester Derivatives and Conjugates Thereof
Louis J. Rezanka (NIA), U.S. Provisional Application No. 60/623,762
filed 29 Oct 2004 (DHHS Reference No. E-330-2004/0-US-01)
Licensing Contact: Michael Shmilovich; (301) 435-5019;
shmilovm@mail.nih.gov.
Available for licensing and commercial development is a method of
synthesizing EPC (4-Nitrophenyl-6-(O-phosphocholine) hydroxyhexanoate)
and methods of synthesizing phosphocholine analogues and the
phosphocholine conjugates formed therefrom. These molecules have
clinical and research applications as anti-microbial agents.
Specifically, EPC conjugated to protein carriers has been demonstrated
to generate a protective immune response to Streptococcus pneumoniae.
The invention provides a process for EPC synthesis as well as for its
reaction intermediates for use in synthesis.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
[[Page 29333]]
Methods and Compositions for the ex vivo High-Throughput Detection of
Protein/Protein Interactions
Sankar Adhya and Amos Oppenheim (NCI), U.S. Provisional Application No.
60/629,933 filed 23 Nov 2004 (DHHS Reference No. E-264-2004/0-US-01)
Licensing Contact: Cristina Thalhammer-Reyero; (301) 435-4507;
thalhamc@mail.nih.gov.
This invention relates to methods and compositions for the high-
throughput detection of protein-protein interactions using a lambda
phage display system. One of the central challenges in systems biology
is defining the interactome, or set of all protein-protein interactions
within a living cell, as a basis for understanding biological processes
for early diagnosis of disease and for drug development. The invention
provides a novel proteomic toolbox for high-throughput medical research
based in combining phage lambda protein display and recent advances in
manipulation of the phage's genome. The method uses the bacteriophage
lambda vector to express proteins on its surface, and is based on the
use of mutant phage vectors such that only interacting phages will be
able to reproduce and co-infect an otherwise non-permissive host and
produce plaques. The invention allows for the characterization of
bacteriophage display libraries that could be easily adapted to be used
in large-scale functional protein chip assays.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Coacervate Microparticles Useful for the Sustained Release
Administration of Therapeutics Agents
Phillip Heller (NIA), U.S. Provisional Application No. 60/602,651 filed
19 Aug 2004 (DHHS Reference No. E-116-2004/0-US-01)
Licensing Contact: Susan O. Ano; (301) 435-5515; anos@mail.nih.gov.
The described technology is a biodegradable microbead or
microparticle, useful for the sustained localized delivery of
biologically active proteins or other molecules of pharmaceutical
interest. The microbeads are produced from several USP grade materials,
a cationic polymer, an anionic polymer and a binding component (e.g.,
gelatin, chondroitin sulfate and avidin), in predetermined ratios.)
Biologically active proteins are incorporated into preformed microbeads
via an introduced binding moiety under nondenaturing conditions.
Proteins or other biologically active molecules are easily
denatured, and once introduced into the body, rapidly cleared. These
problems are circumvented by first incorporating the protein into the
microbead. Microbeads with protein payloads are then introduced into
the tissue of interest, where the microbeads remain while degrading
into biologically innocuous materials while delivering the protein/drug
payload for adjustable periods of time ranging from hours to weeks.
This technology is an improvement of the microbead technology described
in U.S. Patent No. 5,759,582.
This technology has two commercial applications. The first is a
pharmaceutical drug delivery application. The bead allows the
incorporated protein or drug to be delivered locally at high
concentration, ensuring that therapeutic levels are reached at the
target site while reducing side effects by keeping systemic
concentration low. The microbead accomplishes this while protecting the
biologically active protein from harsh conditions traditionally
encountered during microbead formation/drug formulation.
The microbeads are inert, biodegradable, and allow a sustained
release or multiple-release profile of treatment with various active
agents without major side effects. In addition, the bead maintains
functionality under physiological conditions.
Second, the microbeads and microparticles can be used in various
research assays, such as isolation and separation assays, to bind
target proteins from biological samples. A disadvantage of the
conventional methods is that the proteins become denatured. The
denaturation results in incorrect binding studies or inappropriate
binding complexes being formed. The instant technology corrects this
disadvantage by using a bead created in a more neutral pH environment.
It is this same environment that is used for the binding of the protein
of interest as well.
Lepirudin Adsorbed to Catheter
McDonald Horne (CC), U.S. Provisional Application No. 60/436,439 filed
23 Dec 2002 (DHHS Reference No. E-295-2002/0-US-01); PCT Application
No. PCT/US03/40888 filed 22 Dec 2003, which published as WO 2004/058324
A2 on 15 Jul 2004 (DHHS Reference No. E-295-2002/0-PCT-02)
Licensing Contact: Michael Shmilovich; (301) 435-5018;
shmilovm@mail.nih.gov.
The invention is a method for preventing venous access device (VAD)
thrombosis by coating the VAD catheter with lepirudin, which has been
found to be readily adsorbed by the silicone rubber of the VADs, and is
expected to have good retention properties. VADs typically remain in
place for weeks or months and sometimes cause clotting (thrombosis) of
the veins. Accordingly, the simple technique of soaking a silicone
catheter in lepirudin before venous insertion is the gist of the
invention. Chronically ill patients who must be catheterized for long
periods of time will benefit particularly from this technique which
promises to reduce swelling and pain associated with VAD-induced
thrombosis.
Reference: Horne, MK, Brokaw, KJ. Antithrombin activity of
lepirudin adsorbed to silicone (polydimethylsiloxane) tubing.
Thrombosis Research 2003; 112:111-115.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
VAC-BAC Shuttle Vector System
Bernard Moss, Arban Domi (NIAID), U.S. Provisional Application No. 60/
371,840 filed 10 Apr 2002 (DHHS Reference No. E-355-2001/0-US-01); U.S.
Provisional Application No. 60/402,824 filed 09 Aug 2002 (DHHS
Reference No. E-355-2001/1-US-01); International Patent Application No.
PCT/US03/11183 filed 10 Apr 2003, which published as WO 03/087330 A2 on
23 Oct 2003 (DHHS Reference No. E-355-2001/2-PCT-01); U.S. Patent
Application No. 10/959,392 filed 05 Oct 2004 (DHHS Reference No. E-355-
2001/2-US-02); European Patent Application No. 037183431 filed 10 Apr
2003 (DHHS Reference No. E-355-2001/2-EP-03)
Licensing Contact: Robert M. Joynes; (301) 594-6565;
joynesr@mail.nih.gov.
This invention relates to a VAC-BAC shuttle vector system for the
creation of recombinant poxviruses from DNA cloned in a bacterial
artificial chromosome. A VAC-BAC is a bacterial artificial chromosome
(BAC) containing a vaccinia virus genome (VAC) that can replicate in
bacteria and produce infectious virus in mammalian cells.
The following are some of the uses for a VAC-BAC:
1. VAC-BACs can be used to modify vaccinia virus DNA by deletion,
insertion or point mutation or add new DNA to the VAC genome with
methods developed for bacterial plasmids, rather
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than by recombination in mammalian cells.
2. It can be used to produce recombinant vaccinia viruses for gene
expression.
3. It can be used for the production of modified vaccinia viruses
that have improved safety or immunogenicity.
Advantages of the VAC-BAC shuttle system:
1. VAC-BACs are clonally purified from bacterial colonies before
virus reconstitution in mammalian cells.
2. Manipulation of DNA is much simpler and faster in bacteria than
in mammalian cells.
3. Modified genomes can be characterized prior to virus
reconstitution.
4. Only virus with modified genomes will be produced so that virus
plaque isolations are not needed.
5. Generation of a stock of virus from a VAC-BAC is accomplished
within a week rather than many weeks.
6. Multiple viruses can be generated at the same time since plaque
purification is unnecessary.
References:
1. Domi, A., and B. Moss. 2002. Cloning the vaccinia virus genome
as a bacterial artificial chromosome in Escherichia coli and recovery
of infectious virus in mammalian cells. Proc. Natl. Acad. Sci. USA
99:12415-12420.
2. Domi, A., and B. Moss. 2005. Engineering of a vaccinia virus
bacterial artificial chromosome in Escherichia coli by bacteriophage
lambda-based recombination. Nature Methods 2:95-97.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Dated: May 12, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 05-10064 Filed 5-19-05; 8:45 am]
BILLING CODE 4140-01-P
