Government-Owned Inventions; Availability for Licensing, 14222-14223 [E6-4077]
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14222
Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices
contemplated license should be directed
to Andrew Watkins, Director,
Technology Transfer Office, Centers for
Disease Control and Prevention (CDC),
4770 Buford Highway, Mailstop K–79,
Atlanta, GA 30341, telephone: (770)
488–8610; facsimile: (770) 488–8615.
Dated: March 14, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E6–4048 Filed 3–20–06; 8:45 am]
BILLING CODE 4163–18–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:
sroberts on PROD1PC70 with NOTICES
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.
Rapid Methods for Human Artificial
Chromosome (HAC) Formation
Vladimir Larionov (NCI), Hiroshi
Masumoto (NCI), Megumi Nakano
(NCI), Vladimir Noskov (NCI), Natalay
Kouprina (NCI), J. Carl Barrett (NCI),
et al.
U.S. Provisional Application No. 60/
669,589 filed April 8, 2005 (HHS
Reference No. E–128–2005/0–US–01)
Licensing Contact: Susan Carson, D.
Phil.; 301/435–5020;
carsonsu@mail.nih.gov.
Human artificial chromosomes
(HACs) provide a unique opportunity to
develop a new generation of vectors for
therapeutic use as gene expression and
VerDate Aug<31>2005
19:01 Mar 20, 2006
Jkt 208001
delivery systems. The advantages of a
high-capacity, non-integrating
chromosome-based vector capable of
autonomous replication and long-term
gene expression are evident for potential
use in gene therapy and this area is one
of active research. In particular, the
generation of a functional centromere (a
complex structure needed for
segregation at cell division) has been
recognized as key in the production of
synthetic chromosomes. However, a
typical human centromere extends over
many millions of base pairs containing
mainly alphoid satellite DNA (171 bp
repeating units) organized into higher
order repeats (HORs), which have been
difficult to fully characterize or modify
readily. There remains a need to
elucidate the structural requirements of
alphoid DNA arrays for efficient de
novo assembly of centromere structure
in order to construct HAC vectors able
to carry intact mammalian genes
capable of fully regulated gene
expression and which can be stably
maintained in the host nucleus for use
in gene therapy.
The group of Dr. Larionov at the NCI
and colleagues have recently developed
a novel strategy to rapidly construct
large synthetic alphoid DNA arrays with
a predetermined structure by in vivo
recombination in yeast (Nucleic Acids
Res., Sep 2005; 33: e130). The invention
is a two step method involving (1)
rolling-circle amplification (RCA) of a
short alphoid DNA multimer (e.g. a
dimer) and (2) subsequent assembly of
the amplified fragments by in vivo
homologous recombination during
transformation with a TransformationAssociated Recombination targeting
vector (TAR–NV) into yeast cells. This
method or Recombinational
Amplification of Repeats (RAR) has
been used to construct sets of different
synthetic alphoid DNA arrays varying in
size from 30 to 120 kb which were
shown to be competent in HAC
formation. Thus, these long arrays are
engineered centromere-like regions that
permit construction of mammalian
artificial chromosomes with a
predefined centromeric region structure.
As any nucleotide can be easily changed
into an alphoid dimer before its
amplification, this new system is
optimal for identifying the critical
regions of the alphoid repeat for de novo
centromere seeding.
The Mammalian Artificial
Chromosome Portfolio [HHS Ref. No.
E–128–2005/0–US–01 and HHS Ref. No.
E–253–2000/0–US–03], including
methods of generating engineered
centromeric sequences, mammalian
artificial chromosomes and methods of
their use is available for licensing and
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
will be of direct use to those interested
in vectors providing long-term regulated
expression of genes used in therapy for
human disease.
Related technologies available for
licensing also include: the TAR cloning
Portfolio [HHS Ref. No. E–121–1996/0US–06 (USPN 6,391,642 and global IP
coverage); HHS Ref. No. E–158–2001/0–
US–02, U.S. Publication No. US2004/
0248289 filed October 4, 2002].
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Transformation-Associated
Recombination (TAR) Cloning
Vladimir Larionov (NCI), Natalay
Kouprina (NCI), Michael A. Resnick
(NIEHS), et al.
U.S. Patent No. 6,391,642 issued May
21, 2002 (HHS Reference No. E–121–
1996/0–US–06) and global IP coverage
Licensing Contact: Susan Carson, D.
Phil., 301/435–5020;
carsonsu@mail.nih.gov.
Transformation-Associated
Recombination (TAR) cloning in yeast is
a unique method for selective isolation
of large chromosomal fragments or
entire genes from complex genomes
without the time-consuming step of
library construction (PNAS (1996) 93,
491–496). The technique involves
homologous recombination during yeast
spheroplast transformation between
genomic DNA and a TAR vector that has
short (approximately 60bp) 5’ and 3’
gene targeting sequences (hooks).
Further, because up to 15% sequence
divergence does not prevent
recombination in yeast, TAR cloning is
highly efficient for isolation of gene
homologs and synthenic regions. Using
this technology, chromosomal regions
up to 250kb can be rescued in yeast as
circular YACs within 3–5 working days
(NAR (2003) 31, e29; Current Protocols
in Human Genetics (1999) 5.17.1).
NIH researchers Drs. Larionov,
Kouprina and Resnick have championed
the use of this technology and TAR
cloning has been used to efficiently
isolate haplotypes, gene families
(Genome Research (2005) 15, 1477) as
well as genomic regions which are not
present in existing BAC libraries.
Known mutations and new
modifications, including point
mutations, deletions and insertions, can
easily be introduced into DNA
fragments hundreds of kilobases in size
without introducing any unwanted
alterations. The modified DNAs can
then be tested functionally in
mammalian cells and transgenic mice.
TAR has also been used for structural
E:\FR\FM\21MRN1.SGM
21MRN1
Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices
sroberts on PROD1PC70 with NOTICES
biology studies, long-range haplotyping,
evolutionary studies, centromere
analysis and analysis of other regions
which cannot be cloned by a routine
technique based on in vitro ligation
(Kouprina and Larionov (2005) Recent
Developments in Nucleic Acids
Research, in press). In particular,
construction of human artificial
chromosome vectors and the combining
of a HAC vector with a gene of interest
can be effectively performed using the
TAR methodology. Human genes
isolated by TAR for expression in HACs
include HPRT (60kb), BRCA1 (84kb),
BRCA2 (90kb), PTEN (120kb), hTERT
(60kb), KA11 (200kb), ASPM (70kb),
SPANX–C (83kb) among others. TAR is
a flexible and efficient means for
employing in vivo recombination in
yeast in order to clone entire genomic
loci which can then be used for
structural and functional analysis and
for expression in HAC vectors for a
variety of uses including for potential
use in gene therapy.
The TAR cloning Portfolio [HHS Ref.
No. E–121–1996/0–US–06 and HHS Ref.
No. E–158–2001/0–US–02, U.S. Patent
Application Publication No. US2004/
0248289 filed 04 Oct 2002], including
methods of use and vectors, is available
for licensing and will be of direct use to
those using a functional genomics
approach in their work.
Related technologies available for
licensing also include: the Mammalian
Artificial Chromosome Portfolio [HHS
Ref. No. E–128–2005/0–US–01, U.S.
Provisional Patent Application No. 60/
669,589 filed 08 Apr 2005 and HHS Ref.
No. E–253–2000/0–US–03, U.S. Patent
Application Publication No. U.S. 2004/
0245317 filed April 8, 2002].
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Monoclonal Antibodies Which
Specifically Bind to the Ligand
Hepatocyte Growth Factor (HGF) and
are Useful in the Treatment of Cancer
Boliang Cao and George Vande Woude
(both of NCI)
U.S. Patent Application No. 10/129,596
filed September 30, 2002 (HHS
Reference No. E–262–1999/1-US–02),
which is a 371 application of PCT/
US00/31036 filed November 9, 2000
and which claims priority to U.S.
Provisional Application No. 60/
164,173 filed November 9, 1999
Licensing Contact: Susan S. Rucker;
301/435–4478;
ruckersu@mail.nih.gov.
The invention described and claimed
in this patent application provides for
VerDate Aug<31>2005
19:01 Mar 20, 2006
Jkt 208001
compositions and methods for the
treatment of cancers associated with
hepatocyte growth factor (HGF). In
particular, the patent application
describes compositions and methods
which employ a combination of
monoclonal antibodies which bind to
HGF and prevent it from binding to its
receptor met in a manner that HGF/met
signaling is neutralized. The
combination of monoclonal antibodies
has been shown to be neutralizing in
tumor-bearing nude mice.
HGF/met signaling has been most
widely studied in settings related to
cancer. It has been demonstrated to have
a role in metastasis and angiogenesis. In
addition to cancer, HGF activity has also
been linked, through its role in
apoptosis, to Alzheimer’s disease and
cardiovascular disease.
The application has been published as
WO 01/34650 (May 17, 2001). The work
has also been published at Cao B, et al
PNAS USA 98(13):7443–8 (June 19,
2001) [https://www.pnas.org/cgi/content/
full/98/13/7443]. The hybridomas
which can be used to produce the
various monoclonal antibodies have
been deposited with the ATCC and are
available to licensees. Only U.S. Patent
protection has been sought for this
technology. There are no foreign
counterpart patent applications. This
application is available for license only.
Licenses for the development of
therapeutics may be exclusive or nonexclusive. The principal investigators
are no longer at the NIH and are not
available for NIH collaborative projects
under the CRADA mechanism.
Dated: March 14, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–4077 Filed 3–20–06; 8:45 am]
14223
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Office of AIDS
Research Advisory Council.
Date: April 6–7, 2006.
Time: 8:30 a.m. to 1 p.m.
Agenda: A Report of the Director
addressing OAR initiatives. The topic of the
meeting will be addressing prevention
research priorities, focusing on microbicides
research.
Place: Fishers Lane Conference Center,
5635 Fishers Lane, Rockville, MD 20852.
Contact Person: Christina Brackna,
Executive Secretary, Office of Aids Research,
Office of the Director, NIH, 2 Center Drive,
MSC 0255, Building 2, Room 4W15,
Bethesda, MD 20892. (301) 402–3555.
cm53v@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: www.nih.gov/
od/oar/index.htm, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
BILLING CODE 4140–01–P
Dated: March 15, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–2728 Filed 3–20–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–M
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Office of AIDS Research Advisory
Council.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[Federal Register Volume 71, Number 54 (Tuesday, March 21, 2006)]
[Notices]
[Pages 14222-14223]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4077]
-----------------------------------------------------------------------
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.
Rapid Methods for Human Artificial Chromosome (HAC) Formation
Vladimir Larionov (NCI), Hiroshi Masumoto (NCI), Megumi Nakano (NCI),
Vladimir Noskov (NCI), Natalay Kouprina (NCI), J. Carl Barrett (NCI),
et al.
U.S. Provisional Application No. 60/669,589 filed April 8, 2005 (HHS
Reference No. E-128-2005/0-US-01)
Licensing Contact: Susan Carson, D. Phil.; 301/435-5020;
carsonsu@mail.nih.gov.
Human artificial chromosomes (HACs) provide a unique opportunity to
develop a new generation of vectors for therapeutic use as gene
expression and delivery systems. The advantages of a high-capacity,
non-integrating chromosome-based vector capable of autonomous
replication and long-term gene expression are evident for potential use
in gene therapy and this area is one of active research. In particular,
the generation of a functional centromere (a complex structure needed
for segregation at cell division) has been recognized as key in the
production of synthetic chromosomes. However, a typical human
centromere extends over many millions of base pairs containing mainly
alphoid satellite DNA (171 bp repeating units) organized into higher
order repeats (HORs), which have been difficult to fully characterize
or modify readily. There remains a need to elucidate the structural
requirements of alphoid DNA arrays for efficient de novo assembly of
centromere structure in order to construct HAC vectors able to carry
intact mammalian genes capable of fully regulated gene expression and
which can be stably maintained in the host nucleus for use in gene
therapy.
The group of Dr. Larionov at the NCI and colleagues have recently
developed a novel strategy to rapidly construct large synthetic alphoid
DNA arrays with a predetermined structure by in vivo recombination in
yeast (Nucleic Acids Res., Sep 2005; 33: e130). The invention is a two
step method involving (1) rolling-circle amplification (RCA) of a short
alphoid DNA multimer (e.g. a dimer) and (2) subsequent assembly of the
amplified fragments by in vivo homologous recombination during
transformation with a Transformation-Associated Recombination targeting
vector (TAR-NV) into yeast cells. This method or Recombinational
Amplification of Repeats (RAR) has been used to construct sets of
different synthetic alphoid DNA arrays varying in size from 30 to 120
kb which were shown to be competent in HAC formation. Thus, these long
arrays are engineered centromere-like regions that permit construction
of mammalian artificial chromosomes with a predefined centromeric
region structure. As any nucleotide can be easily changed into an
alphoid dimer before its amplification, this new system is optimal for
identifying the critical regions of the alphoid repeat for de novo
centromere seeding.
The Mammalian Artificial Chromosome Portfolio [HHS Ref. No. E-128-
2005/0-US-01 and HHS Ref. No. E-253-2000/0-US-03], including methods of
generating engineered centromeric sequences, mammalian artificial
chromosomes and methods of their use is available for licensing and
will be of direct use to those interested in vectors providing long-
term regulated expression of genes used in therapy for human disease.
Related technologies available for licensing also include: the TAR
cloning Portfolio [HHS Ref. No. E-121-1996/0-US-06 (USPN 6,391,642 and
global IP coverage); HHS Ref. No. E-158-2001/0-US-02, U.S. Publication
No. US2004/0248289 filed October 4, 2002].
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Transformation-Associated Recombination (TAR) Cloning
Vladimir Larionov (NCI), Natalay Kouprina (NCI), Michael A. Resnick
(NIEHS), et al.
U.S. Patent No. 6,391,642 issued May 21, 2002 (HHS Reference No. E-121-
1996/0-US-06) and global IP coverage
Licensing Contact: Susan Carson, D. Phil., 301/435-5020;
carsonsu@mail.nih.gov.
Transformation-Associated Recombination (TAR) cloning in yeast is a
unique method for selective isolation of large chromosomal fragments or
entire genes from complex genomes without the time-consuming step of
library construction (PNAS (1996) 93, 491-496). The technique involves
homologous recombination during yeast spheroplast transformation
between genomic DNA and a TAR vector that has short (approximately
60bp) 5' and 3' gene targeting sequences (hooks). Further, because up
to 15% sequence divergence does not prevent recombination in yeast, TAR
cloning is highly efficient for isolation of gene homologs and
synthenic regions. Using this technology, chromosomal regions up to
250kb can be rescued in yeast as circular YACs within 3-5 working days
(NAR (2003) 31, e29; Current Protocols in Human Genetics (1999)
5.17.1).
NIH researchers Drs. Larionov, Kouprina and Resnick have championed
the use of this technology and TAR cloning has been used to efficiently
isolate haplotypes, gene families (Genome Research (2005) 15, 1477) as
well as genomic regions which are not present in existing BAC
libraries. Known mutations and new modifications, including point
mutations, deletions and insertions, can easily be introduced into DNA
fragments hundreds of kilobases in size without introducing any
unwanted alterations. The modified DNAs can then be tested functionally
in mammalian cells and transgenic mice. TAR has also been used for
structural
[[Page 14223]]
biology studies, long-range haplotyping, evolutionary studies,
centromere analysis and analysis of other regions which cannot be
cloned by a routine technique based on in vitro ligation (Kouprina and
Larionov (2005) Recent Developments in Nucleic Acids Research, in
press). In particular, construction of human artificial chromosome
vectors and the combining of a HAC vector with a gene of interest can
be effectively performed using the TAR methodology. Human genes
isolated by TAR for expression in HACs include HPRT (60kb), BRCA1
(84kb), BRCA2 (90kb), PTEN (120kb), hTERT (60kb), KA11 (200kb), ASPM
(70kb), SPANX-C (83kb) among others. TAR is a flexible and efficient
means for employing in vivo recombination in yeast in order to clone
entire genomic loci which can then be used for structural and
functional analysis and for expression in HAC vectors for a variety of
uses including for potential use in gene therapy.
The TAR cloning Portfolio [HHS Ref. No. E-121-1996/0-US-06 and HHS
Ref. No. E-158-2001/0-US-02, U.S. Patent Application Publication No.
US2004/0248289 filed 04 Oct 2002], including methods of use and
vectors, is available for licensing and will be of direct use to those
using a functional genomics approach in their work.
Related technologies available for licensing also include: the
Mammalian Artificial Chromosome Portfolio [HHS Ref. No. E-128-2005/0-
US-01, U.S. Provisional Patent Application No. 60/669,589 filed 08 Apr
2005 and HHS Ref. No. E-253-2000/0-US-03, U.S. Patent Application
Publication No. U.S. 2004/0245317 filed April 8, 2002].
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Monoclonal Antibodies Which Specifically Bind to the Ligand Hepatocyte
Growth Factor (HGF) and are Useful in the Treatment of Cancer
Boliang Cao and George Vande Woude (both of NCI)
U.S. Patent Application No. 10/129,596 filed September 30, 2002 (HHS
Reference No. E-262-1999/1-US-02), which is a 371 application of PCT/
US00/31036 filed November 9, 2000 and which claims priority to U.S.
Provisional Application No. 60/164,173 filed November 9, 1999
Licensing Contact: Susan S. Rucker; 301/435-4478;
ruckersu@mail.nih.gov.
The invention described and claimed in this patent application
provides for compositions and methods for the treatment of cancers
associated with hepatocyte growth factor (HGF). In particular, the
patent application describes compositions and methods which employ a
combination of monoclonal antibodies which bind to HGF and prevent it
from binding to its receptor met in a manner that HGF/met signaling is
neutralized. The combination of monoclonal antibodies has been shown to
be neutralizing in tumor-bearing nude mice.
HGF/met signaling has been most widely studied in settings related
to cancer. It has been demonstrated to have a role in metastasis and
angiogenesis. In addition to cancer, HGF activity has also been linked,
through its role in apoptosis, to Alzheimer's disease and
cardiovascular disease.
The application has been published as WO 01/34650 (May 17, 2001).
The work has also been published at Cao B, et al PNAS USA 98(13):7443-8
(June 19, 2001) [https://www.pnas.org/cgi/content/full/98/13/7443]. The
hybridomas which can be used to produce the various monoclonal
antibodies have been deposited with the ATCC and are available to
licensees. Only U.S. Patent protection has been sought for this
technology. There are no foreign counterpart patent applications. This
application is available for license only. Licenses for the development
of therapeutics may be exclusive or non-exclusive. The principal
investigators are no longer at the NIH and are not available for NIH
collaborative projects under the CRADA mechanism.
Dated: March 14, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E6-4077 Filed 3-20-06; 8:45 am]
BILLING CODE 4140-01-P
