Government-Owned Inventions; Availability for Licensing, 28702-28703 [E7-9845]
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Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices
the Administrator, Health Resources
and Services Administration. The
Bureau of Primary Health Care includes
the following components:
(1) Office of the Associate
Administrator (RC);
(2) Office of Minority and Special
Populations (RCG);
(3) Office of Policy and Program
Development (RCH);
(4) Office of Quality and Data (RCK);
(5) Eastern Division (RCN);
(6) Central Mid-Atlantic Division
(RCP);
(7) Western Division (RCQ);
(8) Division of National Hansen’s
Disease Programs (RC7); and
(9) Division Immigration Health
Service (RC9).
Section RC–20, Functions
(1) Delete the functional statement for
the Office of the Associate
Administrator (RC) and replace in its
entirety; and (2) Delete the functional
statement for the Office of
Administrative Management (RCM).
Office of the Associate Administrator
(RC)
jlentini on PROD1PC65 with NOTICES
Provides overall leadership, direction,
coordination, and planning in support
of Bureau of Primary Health Care
programs that are designed to improve
the health of the Nation’s underserved
communities and vulnerable
populations by assuring access to
comprehensive, culturally competent,
quality primary health care services.
Specifically, (1) Establishes program
goals, objectives and priorities, and
provides oversight as to their execution;
(2) plans, directs, coordinates and
evaluates Bureau-wide management
activities; (3) maintains effective
relationships within HRSA and with
other Department of Health and Human
Services (HHS) organizations, other
Federal agencies, State and local
governments, and other public and
private organizations concerned with
primary health care, eliminating health
disparities, and improving the health
status of the Nation’s underserved and
vulnerable populations; and (4) plans,
directs, and coordinates Bureau-wide
administrative management activities,
i.e., budget, finance, personnel,
procurements, delegations of authority,
emergency planning, training, executive
secretariat, and has responsibilities
related to the awarding of BPHC grant
and contract funds.
Section RC–30, Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
VerDate Aug<31>2005
18:21 May 21, 2007
Jkt 211001
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
the date of signature.
Dated: May 15, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–9786 Filed 5–21–07; 8:45 am]
BILLING CODE 4165–15–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
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.
Compositions and Methods for
Increasing Recombinant Protein Yields
Through the Modification of Cellular
Properties
Description of Technology: This
technology relates to compositions and
methods for improving the growth
characteristics of cells engineered to
produce biologically active products
such as antibodies or glycosylated
proteins. Featured is a method that uses
gene candidates (e.g., cdkl3, siat7e, or
lama4), or their expressed or inhibited
products in cell lines, such as Human
Embryonic Kidney (including HEK–
293), HeLa, or Chinese Hamster Ovary
(CHO). The gene expression modulates
growth characteristics, such as adhesion
properties, of the cell lines thereby
PO 00000
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Fmt 4703
Sfmt 4703
increasing recombinant protein yields
and reducing product production costs.
Applications: This technology may be
used to improve production of
therapeutic and/or diagnostic
compounds, including therapeutic
proteins or monoclonal antibodies from
mammalian cells. Optimization of
mammalian cells for use as expression
systems in the production of
biologically active products is very
difficult. For certain applications,
anchorage-independent cell lines may
be preferred, whereas for other
applications, a cell line that adheres to
a surface, e.g. is anchorage-dependent,
may be preferable. This technology
provides a method for identifying a gene
whose expression modulates such
cellular adhesion characteristics. This
method thus leads to an increase in the
expression or yield of polypeptides,
including therapeutic biologicals, such
as antibodies, cytokines, growth factors,
enzymes, immunomodulators,
thrombolytics, glycosylated proteins,
secreted proteins, and DNA sequences
encoding such polypeptides and a
reduction in the associated costs of such
biological products.
Advantages: This technology offers
the ability to improve yields and reduce
the cost associated with the production
of recombinant protein products
through the selection of cell lines
having: Altered growth characteristics;
altered adhesion characteristics; altered
rate of proliferation; improvement in
cell density growth; improvement in
recombinant protein expression level.
Market: Biopharmaceuticals,
including recombinant therapeutic
proteins and monoclonal antibodybased products used for in vivo medical
purposes and nucleic acid based
medicinal products now represent
approximately one in every four new
pharmaceuticals on the market. The
market size has been estimated at $33
billion in 2004 and is projected to reach
$70 billion by the end of the decade.
The list of approved biopharmaceuticals
includes recombinant hormones and
growth factors, mAB-based products
and therapeutic enzymes as well as
recombinant vaccines and nucleic acid
based products.
Mammalian cells are widely used
expression systems for the production of
biopharmaceuticals. Human embryo
kidney (including HEK–293) and
Chinese hamster ovary (CHO) are host
cell of choice. The genes identified in
this technology (e.g., cdkl3, sia7e, or
lama4) can be used to modify these
important cell based systems.
This technology is ready for use in
drug/vaccine discovery, production and
development. The technology provides
E:\FR\FM\22MYN1.SGM
22MYN1
Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices
jlentini on PROD1PC65 with NOTICES
methods for identification of specific
gene targets useful for altering the
production properties of either existing
cell lines to improve yields or with new
cell lines for the production of
therapeutic and or diagnostic
compounds from mammalian cells.
Companies that are actively seeking
production platforms based on
mammalian cell lines that offer high
efficiency, high throughput systems for
protein production or analysis at lower
cost and ease of scale-up would be
potential licensors of this technology.
Development Status: Late Stage—
Ready for Production.
Inventors:Joseph Shiloach (NIDDK),
Pratik Jaluria (NIDDK).
Related Publication: P Jaluria et
al.Application of microarrays to identify
and characterize genes involved in
attachment dependence in HeLa cells.
Metab Eng. 2006 Dec 13, Epub ahead of
print, doi:10.1016/j.ymben.2006.12.001.
Patent Status: U.S. Provisional
Application No. 60/840,381 filed 24
Aug 2006 (HHS Reference No. E–149–
2006/0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases,
Biotechnology Core Laboratory, is
seeking parties interested in
collaborative research projects directed
toward the use of this technology with
cells for drug and vaccine production
and development, including growth
optimization, production and product
recovery processes. For more
information, please contact Dr. Joseph
Shiloach, josephs@intra.niddk.nih.gov,
or Rochelle S. Blaustein at
Rochelle.Blaustein@nih.gov.
In Vitro Model for Hepatitis C Virion
Production
Description of Technology: This
invention provides an in vitro hepatitis
C virus (HCV) replication system that is
capable of producing viral particles in a
culture medium. Hepatitis C is a major
public health problem, the development
of therapeutics for which has been
hampered by a lack of a robust model
system to study the complete viral life
cycle. This invention provides a new
model system for the complete
replication cycle of hepatitis C virus and
virion production, assembly and release.
The model is useful for screening
antiviral agents against HCV.
A full length HCV construct, CG1b of
genotype 1b which is known to be
infectious, was placed between two
VerDate Aug<31>2005
18:21 May 21, 2007
Jkt 211001
ribozymes designed to generate the
exact 5′ and 3′ ends of HCV when
cleaved. Using this system, HCV
proteins and positive and negative RNA
strands have been shown to reproduce
intracellularly, and viral particles that
resemble authentic HCV virions are
produced and secreted into the culture
medium.
The patent application includes
claims directed toward the following: a
construct comprising specific nucleic
acid sequences including HCV genotype
1b, genotype 1a, genotype 2a or
potentially other genotypes; a method
for identifying a cell line that is
permissive for infection with HCV; a
method for propagating HCV in vitro; a
method for screening agents capable of
modulating HCV replication or activity;
a method for testing the level of HCV
replication or activity; a HCV vaccine
comprising HCV virus particles.
Applications: The model offers a
novel method for investigating the
entire HCV life cycle including
replication and pathogenesis and is
useful for high-throughput antiviral
screening. This technique may also be
useful for making infectious particles
that are useful in the production of HCV
vaccines.
Advantages: This system provides a
new, stable and efficient cell culture
model to further study the life cycle and
biology of HCV, and to test potential
therapeutic targets for hepatitis C. This
model has also been used to generate in
cell culture HCV strains infectious for
chimpanzees, the only experimental
animal susceptible to infection with the
hepatitis C virus, a critical step in the
development of new vaccines for
Hepatitis C.
Market: Hepatitis C virus (HCV)
chronically infects approximately 200
million people worldwide and increases
the risk of developing cirrhosis and
hepatocellular carcinoma. This
technology would be useful for studying
the HCV life cycle, screening for
therapeutic agents against multiple HCV
strains, including Genotype 1a, 1b and
2a, and the development of HCV
vaccines. HCV genotypes 1 and 2 are the
major genotypes with worldwide
distribution; they are known to be
associated with different clinical
profiles and therapeutic responses.
Hence, the model may be used to screen
for varying levels of effectiveness of
therapeutics against the major HCV
genotypes.
Development Status: This technology
is available for use in diagnostics, drug/
vaccine discovery, production and
development. Current work is directed
toward studies into the HCV life cycle
and replication and the pathogenesis of
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
28703
HCV screening for antiviral agents
against multiple HCV strains. This
model has been used to generate in cell
culture HCV strains infectious for
chimpanzees, the only experimental
animal susceptible to infection with the
hepatitis C virus, a critical step in the
development of new vaccines for
Hepatitis C. Future work may be
directed toward the use of this system
for development of vaccine candidates
against HCV.
Inventors: T. Jake Liang (NIDDK),
Theo Heller (NIDDK)
Related Publications:
1. Z Hu et al. Altered proteolysis and
global gene expression in hepatitis B
virus X transgenic mouse liver. J Virol.
2006 Feb;80(3):1405–1413.
2. T Heller et al. An in vitro model of
hepatitis C virion production. Proc Natl
Acad Sci USA. 2005 Feb
15;102(7):2579–2583.
Patent Status: PCT Application No.
PCT/US2005/035487 filed 30 Sep 2005
(HHS Reference No. E–324–2004/3–
PCT–01), based on: U.S. Provisional
Application No. 60/615,301 filed 30 Sep
2004 (HHS Reference No. E–324–2004/
0–US–01), now abandoned; U.S.
Provisional Application No. 60/642,210
filed 06 Jan 2005 (HHS Reference No. E–
324–2004/1–US–01), now abandoned;
and U.S. Provisional Application No.
60/720,692 filed 26 Sep 2005 (HHS
Reference No. E–324–2004/2–US–01),
now abandoned.
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases, Liver
Diseases Branch, is seeking parties
interested in collaborative research
directed toward molecular strategies for
vaccine and antiviral development, and
animal models of viral hepatitis C.
Please contact Dr. T. Jake Liang at 301–
496–1721, jliang@nih.gov or Rochelle S.
Blaustein at Rochelle.Blaustein@nih.gov
for more information.
Dated: May 14 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer,Office of Technology
Transfer,National Institutes of Health.
[FR Doc. E7–9845 Filed 5–21–07; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 72, Number 98 (Tuesday, May 22, 2007)]
[Notices]
[Pages 28702-28703]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9845]
-----------------------------------------------------------------------
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.
Compositions and Methods for Increasing Recombinant Protein Yields
Through the Modification of Cellular Properties
Description of Technology: This technology relates to compositions
and methods for improving the growth characteristics of cells
engineered to produce biologically active products such as antibodies
or glycosylated proteins. Featured is a method that uses gene
candidates (e.g., cdkl3, siat7e, or lama4), or their expressed or
inhibited products in cell lines, such as Human Embryonic Kidney
(including HEK-293), HeLa, or Chinese Hamster Ovary (CHO). The gene
expression modulates growth characteristics, such as adhesion
properties, of the cell lines thereby increasing recombinant protein
yields and reducing product production costs.
Applications: This technology may be used to improve production of
therapeutic and/or diagnostic compounds, including therapeutic proteins
or monoclonal antibodies from mammalian cells. Optimization of
mammalian cells for use as expression systems in the production of
biologically active products is very difficult. For certain
applications, anchorage-independent cell lines may be preferred,
whereas for other applications, a cell line that adheres to a surface,
e.g. is anchorage-dependent, may be preferable. This technology
provides a method for identifying a gene whose expression modulates
such cellular adhesion characteristics. This method thus leads to an
increase in the expression or yield of polypeptides, including
therapeutic biologicals, such as antibodies, cytokines, growth factors,
enzymes, immunomodulators, thrombolytics, glycosylated proteins,
secreted proteins, and DNA sequences encoding such polypeptides and a
reduction in the associated costs of such biological products.
Advantages: This technology offers the ability to improve yields
and reduce the cost associated with the production of recombinant
protein products through the selection of cell lines having: Altered
growth characteristics; altered adhesion characteristics; altered rate
of proliferation; improvement in cell density growth; improvement in
recombinant protein expression level.
Market: Biopharmaceuticals, including recombinant therapeutic
proteins and monoclonal antibody-based products used for in vivo
medical purposes and nucleic acid based medicinal products now
represent approximately one in every four new pharmaceuticals on the
market. The market size has been estimated at $33 billion in 2004 and
is projected to reach $70 billion by the end of the decade. The list of
approved biopharmaceuticals includes recombinant hormones and growth
factors, mAB-based products and therapeutic enzymes as well as
recombinant vaccines and nucleic acid based products.
Mammalian cells are widely used expression systems for the
production of biopharmaceuticals. Human embryo kidney (including HEK-
293) and Chinese hamster ovary (CHO) are host cell of choice. The genes
identified in this technology (e.g., cdkl3, sia7e, or lama4) can be
used to modify these important cell based systems.
This technology is ready for use in drug/vaccine discovery,
production and development. The technology provides
[[Page 28703]]
methods for identification of specific gene targets useful for altering
the production properties of either existing cell lines to improve
yields or with new cell lines for the production of therapeutic and or
diagnostic compounds from mammalian cells.
Companies that are actively seeking production platforms based on
mammalian cell lines that offer high efficiency, high throughput
systems for protein production or analysis at lower cost and ease of
scale-up would be potential licensors of this technology.
Development Status: Late Stage--Ready for Production.
Inventors:Joseph Shiloach (NIDDK), Pratik Jaluria (NIDDK).
Related Publication: P Jaluria et al.Application of microarrays to
identify and characterize genes involved in attachment dependence in
HeLa cells. Metab Eng. 2006 Dec 13, Epub ahead of print, doi:10.1016/
j.ymben.2006.12.001.
Patent Status: U.S. Provisional Application No. 60/840,381 filed 24
Aug 2006 (HHS Reference No. E-149-2006/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases, Biotechnology Core
Laboratory, is seeking parties interested in collaborative research
projects directed toward the use of this technology with cells for drug
and vaccine production and development, including growth optimization,
production and product recovery processes. For more information, please
contact Dr. Joseph Shiloach, josephs@intra.niddk.nih.gov, or Rochelle
S. Blaustein at Rochelle.Blaustein@nih.gov.
In Vitro Model for Hepatitis C Virion Production
Description of Technology: This invention provides an in vitro
hepatitis C virus (HCV) replication system that is capable of producing
viral particles in a culture medium. Hepatitis C is a major public
health problem, the development of therapeutics for which has been
hampered by a lack of a robust model system to study the complete viral
life cycle. This invention provides a new model system for the complete
replication cycle of hepatitis C virus and virion production, assembly
and release. The model is useful for screening antiviral agents against
HCV.
A full length HCV construct, CG1b of genotype 1b which is known to
be infectious, was placed between two ribozymes designed to generate
the exact 5' and 3' ends of HCV when cleaved. Using this system, HCV
proteins and positive and negative RNA strands have been shown to
reproduce intracellularly, and viral particles that resemble authentic
HCV virions are produced and secreted into the culture medium.
The patent application includes claims directed toward the
following: a construct comprising specific nucleic acid sequences
including HCV genotype 1b, genotype 1a, genotype 2a or potentially
other genotypes; a method for identifying a cell line that is
permissive for infection with HCV; a method for propagating HCV in
vitro; a method for screening agents capable of modulating HCV
replication or activity; a method for testing the level of HCV
replication or activity; a HCV vaccine comprising HCV virus particles.
Applications: The model offers a novel method for investigating the
entire HCV life cycle including replication and pathogenesis and is
useful for high-throughput antiviral screening. This technique may also
be useful for making infectious particles that are useful in the
production of HCV vaccines.
Advantages: This system provides a new, stable and efficient cell
culture model to further study the life cycle and biology of HCV, and
to test potential therapeutic targets for hepatitis C. This model has
also been used to generate in cell culture HCV strains infectious for
chimpanzees, the only experimental animal susceptible to infection with
the hepatitis C virus, a critical step in the development of new
vaccines for Hepatitis C.
Market: Hepatitis C virus (HCV) chronically infects approximately
200 million people worldwide and increases the risk of developing
cirrhosis and hepatocellular carcinoma. This technology would be useful
for studying the HCV life cycle, screening for therapeutic agents
against multiple HCV strains, including Genotype 1a, 1b and 2a, and the
development of HCV vaccines. HCV genotypes 1 and 2 are the major
genotypes with worldwide distribution; they are known to be associated
with different clinical profiles and therapeutic responses. Hence, the
model may be used to screen for varying levels of effectiveness of
therapeutics against the major HCV genotypes.
Development Status: This technology is available for use in
diagnostics, drug/vaccine discovery, production and development.
Current work is directed toward studies into the HCV life cycle and
replication and the pathogenesis of HCV screening for antiviral agents
against multiple HCV strains. This model has been used to generate in
cell culture HCV strains infectious for chimpanzees, the only
experimental animal susceptible to infection with the hepatitis C
virus, a critical step in the development of new vaccines for Hepatitis
C. Future work may be directed toward the use of this system for
development of vaccine candidates against HCV.
Inventors: T. Jake Liang (NIDDK), Theo Heller (NIDDK)
Related Publications:
1. Z Hu et al. Altered proteolysis and global gene expression in
hepatitis B virus X transgenic mouse liver. J Virol. 2006
Feb;80(3):1405-1413.
2. T Heller et al. An in vitro model of hepatitis C virion
production. Proc Natl Acad Sci USA. 2005 Feb 15;102(7):2579-2583.
Patent Status: PCT Application No. PCT/US2005/035487 filed 30 Sep
2005 (HHS Reference No. E-324-2004/3-PCT-01), based on: U.S.
Provisional Application No. 60/615,301 filed 30 Sep 2004 (HHS Reference
No. E-324-2004/0-US-01), now abandoned; U.S. Provisional Application
No. 60/642,210 filed 06 Jan 2005 (HHS Reference No. E-324-2004/1-US-
01), now abandoned; and U.S. Provisional Application No. 60/720,692
filed 26 Sep 2005 (HHS Reference No. E-324-2004/2-US-01), now
abandoned.
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases, Liver Diseases Branch, is
seeking parties interested in collaborative research directed toward
molecular strategies for vaccine and antiviral development, and animal
models of viral hepatitis C. Please contact Dr. T. Jake Liang at 301-
496-1721, jliang@nih.gov or Rochelle S. Blaustein at
Rochelle.Blaustein@nih.gov for more information.
Dated: May 14 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-9845 Filed 5-21-07; 8:45 am]
BILLING CODE 4140-01-P
