Government-Owned Inventions; Availability for Licensing, 34377-34378 [E6-9302]
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Federal Register / Vol. 71, No. 114 / Wednesday, June 14, 2006 / Notices
suitable CRADA collaborator has not
been selected.
FOR FURTHER INFORMATION CONTACT:
Queries and capability statements
should be addressed to William C.
Ronnenberg, JD, M.I.P., Office of
Technology Development, National
Institute of Allergy and Infectious
Diseases, 6610 Rockledge Drive, Room
4071, MSC 6606, Bethesda, MD 20892–
6606 (Zip Code for Courier: 20817),
telephone 301–451–3522, fax: 301–402–
7123, e-mail:
wronnenberg@niaid.nih.gov.
SUPPLEMENTARY INFORMATION: With the
increased availability of detailed
proteomic data, the main obstacle to
developing realistic software-based
simulation models of cellular signaling
processes is the technical difficulty of
transforming complex biological models
into quantitative simulations. Biological
models typically describe cellular
signaling processes in terms of
bimolecular interactions or the
interaction between specific sites on
two proteins. These bimolecular
interactions can be integrated by
available software into diagrammatic
representations of signaling pathways.
However, these descriptions are
generally qualitative and are not useful
for a quantitative understanding of the
underlying biological systems. For
quantitative representations of
biological models, the current approach
is to ask theorists (mathematicians,
physicists, etc.) to transform these
qualitative models into sets of equations
or automata rules that roughly reflect
the properties of the original model. The
resulting descriptions of complex
biological models are frequently
inadequate because the theorist
involved lacks an understanding of
biological details or the resulting
mathematical descriptions are oversimplified.
The goals of the proposed CRADA are
to integrate an existing software
program for the simulation of multiscale, cellular, biological models with
protein database interfaces and to
improve the software’s graphical user
interface. NIAID has developed, in part,
software that simulates reaction
networks of all possible molecular
interactions in biological systems based
on user inputs. The current
development stage of the software
combines several unique features, such
as a graphical interface for the definition
and simulation of cell biological models
spanning the scale from bi-molecular
interactions to the behavior of cell
populations. Its internal algorithms for
the integration of the partial differential
equations governing the spatio-temporal
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behavior of the simulated biological
system use state-of-the-art approaches to
deal with very large reaction networks
and the stiffness of the equations.
Simulations created with the software
take into account the differential
behavior of cytosolic and membranebound complexes as well as
transmembrane signaling events and
generates the equivalent of a set of
partial differential equations describing
the spatio-temporal dynamics of the
system. The graphical user interface of
the software allows the user to define bimolecular interactions, enzymatic
transformations, (initial) spatial
distribution of the components of
cellular biochemistry and the location of
cells within extracellular spatial
compartments. Based on the initial
distribution of molecules and cells
defined by the user the software then
simulates the behavior of the system
providing a range of different graphical
and tabular representations of the
system’s evolving state. At any time
during the simulations, the user can add
components (cells, molecules) and
query the detailed biochemical state of
cells (localized concentrations of
signaling components) and investigate
how these correlate with the cells’
behavior.
The capability statement must
address, with specificity, each of the
following selection criteria:
(1) A demonstration of expertise and
experience in the areas of design and
coding of biological software with an
extensive GUI component, as well as the
development of supporting
documentation;
(2) A demonstration of and a
willingness to commit reasonable and
adequate resources (including facilities,
equipment, and personnel) the
development of this technology;
(3) A demonstration of the expertise
and ability to commercially develop,
produce, sell, and provide user support
for similar technologies; and
(4) Ability to provide adequate and
sustained funding for CRADA activities.
Dated: June 2, 2006.
Michael R. Mowatt,
Director, Office of Technology Development,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health.
[FR Doc. E6–9301 Filed 6–13–06; 8:45 am]
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34377
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
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.
Generation of Regulatory T Cells for
Immunotherapy
Description of Technology:
Abnormalities in immunoregulation are
responsible for a wide variety of
disorders such as autoimmune disease,
chronic inflammatory diseases, and
allergic diseases. These diseases include
systemic lupus erythematosus,
rheumatoid arthritis, type I diabetes
mellitus, inflammatory bowel disease,
multiple sclerosis, Crohn’s disease and
asthma. The defining event for
induction of an immune-mediated
disorder is the loss of T cell tolerance
to self-antigens, which is provided by
regulatory T cells. Traditional methods
for treating immune-mediated disorders
involve the use of steroids or other
immunosuppressive drugs, which have
significant undesirable side effects.
This invention provides methods for
generating regulatory T cells by
culturing CD4+CD25¥T cells with
autologous antigen-presenting cells
(APCs) in the presence of the Th2
cytokines interleukin-4 (IL-4) and/or
interleukin-13 (IL-13). Immunotherapy
via this mechanism is anticipated to
have a large number of potential
therapeutic applications. Methods are
also provided for treatment of
E:\FR\FM\14JNN1.SGM
14JNN1
34378
Federal Register / Vol. 71, No. 114 / Wednesday, June 14, 2006 / Notices
rwilkins on PROD1PC63 with NOTICES
autoimmune disease or inflammation in
a subject by administration of an IL-4
agonist, as well as methods of treating
cancer by administration of an IL-4
antagonist.
Applications: Therapeutic method for
treatment of autoimmune disease or
inflammation; Therapeutic method to
prevent graft rejection in a transplant
recipient; Therapeutic method for
treatment of cancer; Diagnostic test for
efficacy of an IL-4 antagonist in cancer
treatment.
Development Status: Early stage.
Inventors: Peter E. Lipsky (NIAMS) et
al.
Publication: A Skapenko et al., ‘‘The
IL-4 receptor alpha-chain-binding
cytokines, IL-4 and IL-13, induce
forkhead box P3-expressing CD25+CD4+
regulatory T cells from CD25¥CD4+
precursors,’’ J Immunol. (2005 Nov 1)
175(9):6107–6116.
Patent Status: U.S. Provisional
Application No. 60/728,475 filed 19 Oct
2005 (HHS Reference No. E–010–2005/
1–US–01).
Licensing Status: This technology is
available for exclusive, co-exclusive, or
nonexclusive licensing.
Licensing Contact: Marlene K. Astor,
JD, MS, MIP; 301/435–4426;
ms482m@nih.gov.
Collaborative Research Opportunity:
The NIAMS, Autoimmunity Branch, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize a
process for the generation of regulatory
T cells for immunotherapy. Please
contact Dr. Peter E Lipsky at 301/594–
0596 or lipskyp@mail.nih.gov for more
information.
Method Evolved for Recognition of
Thrombophilia (MERT): Clinical
Predictive Genetic Test for Venous
Thrombosis
Description of Technology: Venous
thrombosis (VT) is one of the leading
causes of mortality and morbidity
resulting in approximately 300,000
hospitalizations and 50,000 fatalities per
year in the United States with an
incidence of 141 per 100,000 AfricanAmericans, 104 per 100,000 Caucasians
and 21 per 100,000 Asian/Pacific
Islanders. However, it is an avoidable
disease if effective preventive measures
such as early thromboprophylaxis are
instituted.
It is highly beneficial to estimate
individual thrombotic risk to aid in
development of individualized riskadapted prophylaxis.
Venous thrombosis is a multifactorial
disorder and occurs as an outcome of a
combination of environmental and
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19:47 Jun 13, 2006
Jkt 208001
genetic risk factors. In addition to wellestablished venous thrombosis
associated acquired or environmental
factors such as surgery, use of oral
contraceptives and/or hormone
replacement therapy, trauma, bone
fractures, prolonged immobilization,
advanced age, previous thrombosis
history, malignancy and pregnancy,
genetic predisposition via a number of
variably penetrant genetic mutations or
polymorphisms impart an increased risk
for venous thrombosis.
In pregnant women, inherited
thrombophilia can greatly increase the
risk of adverse pregnancy outcomes
such as miscarriages, intrauterine
growth restriction, preeclampsia,
placental abruption, or stillbirth as well
as thrombosis during the recovery
period after childbirth.
In addition to the differences in the
prevalence of venous thrombosis among
ethnic groups, there are accumulating
data revealing differences in genetic
determinants among ethnic groups such
as differences in susceptibility
associated genes and even in sequence
alterations of the same gene.
Furthermore some of the mutations and
polymorphisms are mainly restricted to
the specific populations. Such examples
are FV Leiden, prothrombin G20210A
polymorphisms. Whereas FV Leiden
and prothrombin G0210A
polymorphisms are the most prevalent
risk factors for venous thrombosis in
Caucasians, the patients from ethic
populations other than Caucasians
exhibit no or very rare FV Leiden or
prothrombin G20210A polymorphisms.
This invention describes a highlypredictive genetic test to identify
individuals with increased risk for
venous thrombosis. It comprises a rapid,
accurate and affordable genetic screen,
utilizing genomic DNA microarray
technology consisting of a combination
of venous thrombosis associated
mutations and polymorphisms that is
applicable to diverse ethnic
populations. Eight genes (antithrombin
III, PC, PS, fibrinogen, factor V,
prothrombin (factor II), MTHFR and
ACE) are screened for the 143 known
venous thrombosis-associated recurrent
mutations and polymorphisms. This
multi-gene test increases the predictive
power for detection of genetic
susceptibility to thrombosis over 20-fold
compared to single-gene analysis, in
multiple ethnic populations.
Applications: (1) Rapid, cost-effective
predictive test kit to identify
asymptomatic individuals at risk for
venous thrombosis in diverse ethnic
populations; (2) Rapid, cost-effective
predictive test kit to identify pregnant
women at risk for thrombophilia-
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Sfmt 4703
associated adverse pregnancy outcomes
such as miscarriage, intrauterine growth
restriction, preeclampsia, placental
abruption, or stillbirth as well as
postpartum thrombosis; (3) Provides
reduction of the yearly incidence of
venous thrombosis by early
identification of individuals at inherited
risk, allowing protection before they
develop symptoms by instituting
effective preventive measures, such as
early thromboprophylaxis or even
decisions such as avoiding the use of
oral contraceptives or hormone
replacement therapy; (4) Provides
advantages over currently available
plasma-based thrombophilia screening
panel by avoiding underdetermination
of anticoagulant protein deficient
individuals or by avoiding high rates of
false positivity; (5) Allows
individualized management and
anticoagulation treatment of patients
according to inherited thrombophilia
status.
Market: (1) Individuals before or
during exposure to situations that
increase the risk of venous thrombosis,
such as surgery, use of oral
contraceptives and/or hormone
replacement therapy, trauma, bone
fractures, prolonged immobilization,
long air journeys, advanced age,
malignancy, or combinations thereof; (2)
Pregnant women, or women who plan to
become pregnant, as inherited
thrombophilia is a significant risk factor
for adverse pregnancy outcomes such as
miscarriage, intrauterine growth
restriction, preeclampsia, placental
abruption, stillbirth and postpartum
thrombotic events.
Development Status: Validation stage.
Inventors: Cigdem F. Dogulu, Owen
M. Rennert, and Wai-Yee Chan
(NICHD).
Patent Status: PCT Application No.
PCT/US2005/01419 filed 14 Jan 2005,
which published as WO 2005/071114A1
on 04 Aug 2005 (HHS Reference No. E–
282–2003/0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301/435–4521;
sayyidf@mail.nih.gov.
Dated: June 8, 2006.
David R. Sadowski,
Acting Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. E6–9302 Filed 6–13–06; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 71, Number 114 (Wednesday, June 14, 2006)]
[Notices]
[Pages 34377-34378]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9302]
-----------------------------------------------------------------------
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.
Generation of Regulatory T Cells for Immunotherapy
Description of Technology: Abnormalities in immunoregulation are
responsible for a wide variety of disorders such as autoimmune disease,
chronic inflammatory diseases, and allergic diseases. These diseases
include systemic lupus erythematosus, rheumatoid arthritis, type I
diabetes mellitus, inflammatory bowel disease, multiple sclerosis,
Crohn's disease and asthma. The defining event for induction of an
immune-mediated disorder is the loss of T cell tolerance to self-
antigens, which is provided by regulatory T cells. Traditional methods
for treating immune-mediated disorders involve the use of steroids or
other immunosuppressive drugs, which have significant undesirable side
effects.
This invention provides methods for generating regulatory T cells
by culturing CD4+CD25-T cells with autologous antigen-presenting cells
(APCs) in the presence of the Th2 cytokines interleukin-4 (IL-4) and/or
interleukin-13 (IL-13). Immunotherapy via this mechanism is anticipated
to have a large number of potential therapeutic applications. Methods
are also provided for treatment of
[[Page 34378]]
autoimmune disease or inflammation in a subject by administration of an
IL-4 agonist, as well as methods of treating cancer by administration
of an IL-4 antagonist.
Applications: Therapeutic method for treatment of autoimmune
disease or inflammation; Therapeutic method to prevent graft rejection
in a transplant recipient; Therapeutic method for treatment of cancer;
Diagnostic test for efficacy of an IL-4 antagonist in cancer treatment.
Development Status: Early stage.
Inventors: Peter E. Lipsky (NIAMS) et al.
Publication: A Skapenko et al., ``The IL-4 receptor alpha-chain-
binding cytokines, IL-4 and IL-13, induce forkhead box P3-expressing
CD25+CD4+ regulatory T cells from CD25-CD4+ precursors,'' J Immunol.
(2005 Nov 1) 175(9):6107-6116.
Patent Status: U.S. Provisional Application No. 60/728,475 filed 19
Oct 2005 (HHS Reference No. E-010-2005/1-US-01).
Licensing Status: This technology is available for exclusive, co-
exclusive, or nonexclusive licensing.
Licensing Contact: Marlene K. Astor, JD, MS, MIP; 301/435-4426;
ms482m@nih.gov.
Collaborative Research Opportunity: The NIAMS, Autoimmunity Branch,
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize a process for the generation of regulatory T cells for
immunotherapy. Please contact Dr. Peter E Lipsky at 301/594-0596 or
lipskyp@mail.nih.gov for more information.
Method Evolved for Recognition of Thrombophilia (MERT): Clinical
Predictive Genetic Test for Venous Thrombosis
Description of Technology: Venous thrombosis (VT) is one of the
leading causes of mortality and morbidity resulting in approximately
300,000 hospitalizations and 50,000 fatalities per year in the United
States with an incidence of 141 per 100,000 African-Americans, 104 per
100,000 Caucasians and 21 per 100,000 Asian/Pacific Islanders. However,
it is an avoidable disease if effective preventive measures such as
early thromboprophylaxis are instituted.
It is highly beneficial to estimate individual thrombotic risk to
aid in development of individualized risk-adapted prophylaxis.
Venous thrombosis is a multifactorial disorder and occurs as an
outcome of a combination of environmental and genetic risk factors. In
addition to well-established venous thrombosis associated acquired or
environmental factors such as surgery, use of oral contraceptives and/
or hormone replacement therapy, trauma, bone fractures, prolonged
immobilization, advanced age, previous thrombosis history, malignancy
and pregnancy, genetic predisposition via a number of variably
penetrant genetic mutations or polymorphisms impart an increased risk
for venous thrombosis.
In pregnant women, inherited thrombophilia can greatly increase the
risk of adverse pregnancy outcomes such as miscarriages, intrauterine
growth restriction, preeclampsia, placental abruption, or stillbirth as
well as thrombosis during the recovery period after childbirth.
In addition to the differences in the prevalence of venous
thrombosis among ethnic groups, there are accumulating data revealing
differences in genetic determinants among ethnic groups such as
differences in susceptibility associated genes and even in sequence
alterations of the same gene. Furthermore some of the mutations and
polymorphisms are mainly restricted to the specific populations. Such
examples are FV Leiden, prothrombin G20210A polymorphisms. Whereas FV
Leiden and prothrombin G0210A polymorphisms are the most prevalent risk
factors for venous thrombosis in Caucasians, the patients from ethic
populations other than Caucasians exhibit no or very rare FV Leiden or
prothrombin G20210A polymorphisms.
This invention describes a highly-predictive genetic test to
identify individuals with increased risk for venous thrombosis. It
comprises a rapid, accurate and affordable genetic screen, utilizing
genomic DNA microarray technology consisting of a combination of venous
thrombosis associated mutations and polymorphisms that is applicable to
diverse ethnic populations. Eight genes (antithrombin III, PC, PS,
fibrinogen, factor V, prothrombin (factor II), MTHFR and ACE) are
screened for the 143 known venous thrombosis-associated recurrent
mutations and polymorphisms. This multi-gene test increases the
predictive power for detection of genetic susceptibility to thrombosis
over 20-fold compared to single-gene analysis, in multiple ethnic
populations.
Applications: (1) Rapid, cost-effective predictive test kit to
identify asymptomatic individuals at risk for venous thrombosis in
diverse ethnic populations; (2) Rapid, cost-effective predictive test
kit to identify pregnant women at risk for thrombophilia-associated
adverse pregnancy outcomes such as miscarriage, intrauterine growth
restriction, preeclampsia, placental abruption, or stillbirth as well
as postpartum thrombosis; (3) Provides reduction of the yearly
incidence of venous thrombosis by early identification of individuals
at inherited risk, allowing protection before they develop symptoms by
instituting effective preventive measures, such as early
thromboprophylaxis or even decisions such as avoiding the use of oral
contraceptives or hormone replacement therapy; (4) Provides advantages
over currently available plasma-based thrombophilia screening panel by
avoiding underdetermination of anticoagulant protein deficient
individuals or by avoiding high rates of false positivity; (5) Allows
individualized management and anticoagulation treatment of patients
according to inherited thrombophilia status.
Market: (1) Individuals before or during exposure to situations
that increase the risk of venous thrombosis, such as surgery, use of
oral contraceptives and/or hormone replacement therapy, trauma, bone
fractures, prolonged immobilization, long air journeys, advanced age,
malignancy, or combinations thereof; (2) Pregnant women, or women who
plan to become pregnant, as inherited thrombophilia is a significant
risk factor for adverse pregnancy outcomes such as miscarriage,
intrauterine growth restriction, preeclampsia, placental abruption,
stillbirth and postpartum thrombotic events.
Development Status: Validation stage.
Inventors: Cigdem F. Dogulu, Owen M. Rennert, and Wai-Yee Chan
(NICHD).
Patent Status: PCT Application No. PCT/US2005/01419 filed 14 Jan
2005, which published as WO 2005/071114A1 on 04 Aug 2005 (HHS Reference
No. E-282-2003/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301/435-4521;
sayyidf@mail.nih.gov.
Dated: June 8, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-9302 Filed 6-13-06; 8:45 am]
BILLING CODE 4140-01-P
