Government-Owned Inventions; Availability for Licensing, 11995-11997 [05-4675]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices
survey will be one source of input into
a statutorily mandated assessment and
report to the Congress on special
funding for research on type 1 diabetes
provided by the Balanced Budget Act of
1997, (Pub. L. 105–33), the FY 2001
Consolidated Appropriations Act, (Pub.
L. 106–554), and the Public Health
Service Act Amendment for Diabetes,
(Pub. L. 107–360). Collectively, these
Acts provided $1.14 billion in special
funds to the Department of Health and
Human Services (HHS) for research
aimed at understanding, treating and
preventing type 1 diabetes and its
complications. The Secretary of HHS
subsequently designated to NIDDK the
lead responsibility in the Department
for developing a process for allocation
of these funds. The primary objective of
the survey is to gain information, via a
brief questionnaire, from NIH research
grantees, who were the primary
recipients of these special funds,
concerning their views on the impact of
the type 1 diabetes research funding
with respect to: (1) Advancing scientific
accomplishments involving innovative,
clinically relevant, and
multidisciplinary research on type 1
diabetes; (2) developing resources or
reagents useful for type 1 diabetes
research; and (3) increasing the number
and quality of type 1 diabetes
investigators. The responses will
provide valuable information
concerning how the funds have
facilitated research as intended by these
Acts of Congress. The results will also
help determine how research progress
from these special congressional
initiatives fits within the continuum of
diabetes research, and how these funds
have contributed to the field of type 1
diabetes research and NIH efforts to
combat this challenging health problem.
Information from this study will aid in
evaluation of the process by which the
research goals for use of the special type
1 diabetes funds have been developed
and are being pursued. Responses
already collected from this survey were
analyzed as part of an interim program
assessment that was published by the
NIDDK in April, 2003 https://
www.niddk.nih.gov/federal/planning/
type 1_specialfund/. This revised survey
will contribute to a statutorily mandated
report, due to Congress on January 1,
2007, evaluating the process and efforts
under this program and assessing
research initiatives funded by these Acts
of Congress.
Frequency of Response: The initial
survey will require a one time response;
though, respondents may be contacted
again in the event of future
congressionally mandated reports on the
VerDate jul<14>2003
18:28 Mar 09, 2005
Jkt 205001
use of the special type 1 diabetes
research funds.
Affected Public: Research scientists
who received the special funds about
which Congress has mandated in law
the requirements for an evaluation
report. Type of Respondents: Laboratory
and clinical investigators who have
received support from the special type
1 diabetes funds provided under the
laws previously cited. The annual
reporting burden is as follows:
Estimated Number of Respondents: 500;
Estimated Number of Responses per
Respondent: 1 (Respondents will be
given one questionnaire containing an
estimated fifteen questions.); Average
Burden Hours Per Response: 1; and
Estimated Total Annual Burden Hours
Requested: 500. The annualized total
cost to respondents is estimated at:
$25,000. It is expected that the
respondents will be contacted vie e-mail
and that their responses will be
collected through an Internet-accessible
questionnaire. These measures will
reduce the burden on the respondents
and the overall costs of administering
the study. Because different types of
awards have been made with the special
type 1 diabetes funds, the questionnaire
may be tailored such that respondents
will only be asked to answer a subset of
questions that pertain to their particular
type of award(s). No respondent will be
asked to answer more than a total of
fifteen questions, at least one-third of
which will be answered with a ‘‘yes’’ or
‘‘no’’ or a one-word response. There are
no Capital Costs, Operating or
Maintenance Costs to report.
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
11995
instruments, contact Dr. Shefa Gordon,
Office of Scientific Program and Policy
Analysis, NIDDK, NIH, Building 31,
Room 9A31, 9000 Rockville Pike,
Bethesda, MD 20892, or call non-tollfree number 301–496–6623 or e-mail
your request, including your address to:
gordonshefa@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: March 2, 2005.
Lynell Nelson,
Project Clearance Liaison, NIDDK, National
Institutes of Health.
[FR Doc. 05–4674 Filed 3–9–05; 8:45 am]
BILLING CODE 4140–01–M
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.
Dimer Inhibitory Peptides of CXCR4 as
a Possible Novel Therapy for Cancer
Jinhai Wang and Michael Norcross
(FDA),
DHHS Reference No. E–037–2005/0—
Research Tool,
Licensing Contact: John Stansberry;
(301) 435–5236;
stansbej@mail.nih.gov.
This invention may control or inhibit
cancer metastases by targeting
E:\FR\FM\10MRN1.SGM
10MRN1
11996
Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices
chemokine receptor dimer formation.
Specifically, this invention relates to a
synthetic peptide of the transmembrane
region 4 (TM4) of the Chemokine
receptor (CXCR4). TM4 inhibits CXCR4
dimerization and tumor cell migration.
CXCR4 is highly expressed in human
breast cancer cells, prostate cancer, and
pancreatic cancer. CXCR4 is involved in
breast cancer metastasis and tumor
migration. Immunotherapies or
vaccinations based on blocking
chemokine receptor dimerization with
TM4 could be a useful treatment against
proliferative diseases and cancer.
Carbohydrate-Encapsulated Gold
Nanoparticles as Novel Anti-metastatic
Agents
Drs. Joseph Barchi (NCI), Sergei
Svarovsky (NCI) et al.,
DHHS Reference No. E–001–2005/0–
PCT–01,
Licensing Contact: John Stansberry;
(301) 435–5236;
stansbej@mail.nih.gov.
The invention relates to the
development of a new synthesis for the
tumor-associated, cell-surface
carbohydrate moiety, known as the
Thomsen-Friedenrich T antigen. The
inventors prepared a novel, multivalent
presentation platform by linking this
disaccharide antigen to the surface of
gold nanoparticles and describe the
application of the multivalent system as
an anti-adhesive tool to inhibit
metastasis. The glyconanoparticles
principle described here has the
potential to integrate all the current
knowledge and applications on
processes that involve carbohydrate
molecules (inflammation, viral,
bacterial, and toxin infection, etc.).
Administration of these nanoparticles
into mice bearing breast tumors was
shown to inhibit lung metastases in this
model. This technology establishes the
‘‘proof of principle’’ for possible
biological applications of
glyconanoparticles.
In addition to licensing, the
technology is available for further
development through collaborative
research with the inventors via a
Cooperative Research and Development
Agreement (CRADA).
Methods for the Selection of Subjects
for Multiple Sclerosis Therapy
Roland Martin et al. (NINDS),
International Application No. PCT/
US04/10584 filed 05 Apr 2004 (DHHS
Reference No. E–005–2004/0–PCT–
01),
Licensing Contact: Thomas Clouse;
(301) 435–4076;
clousetp@mail.nih.gov.
VerDate jul<14>2003
18:28 Mar 09, 2005
Jkt 205001
Multiple Sclerosis (MS) is a life-long
chronic autoimmune disease diagnosed
primarily in young adults who have a
virtually normal life expectancy.
Estimates place the annual costs of MS
in the United States in excess of $2.5
billion. There are approximately
250,000 to 400,000 persons in the
United States with MS, and
approximately 2.5 million persons
worldwide suffer from MS. A variety of
therapies are used to treat MS, but there
is no single therapy that can be used to
treat all patients. Furthermore, therapies
that are currently approved for MS are
only moderately effective, and in some
patients they have no effect at all. The
invention provides a method to
determine if a patient with MS will
respond to a therapeutic protocol by
analyzing the expression of genes
expressed by the immune system. For
example, a single gene can be assessed,
or an expression profile of a patient can
be created using an array comprising
gene sequences and analyzed to
determine if the patient will respond to
one or more therapeutic protocols. A
cDNA probe constructed from mRNA of
lymphocytes isolated from a patient can
hybridize with a microarray, and the
extent of hybridization of the probes to
each gene on the microarray can be
determined. The microarray can include
nucleic acid sequences encoding, for
example, IL–8, Bcl–2–interacting
protein, dihydrofolate reductase,
gyanylate-binding protein 1, interferoninduced 17 kDa protein, 2′5′ OAS,
plakoglobin, interferon inducible
proteinkinase, and STAT–1, among
others.
Methods for Identifying, Diagnosing,
and Predicting Survival of Lymphomas
Louis M. Staudt et al. (NCI),
PCT Application No. PCT/US2004/
029041 filed 03 Sep 2004 (DHHS
Reference No. E–234–2003/1–PCT–
01) and U.S. Non-Provisional Patent
Application 10/934,930 filed on 03
Sep 2004 (DHHS Reference No. E–
108–2004/0–US–01),
Licensing Contact: Jeff Walenta; (301)
435–4633; walentaj@mail.nih.gov.
Human lymphomas and leukemias are
a diverse set of cancers. Many of these
cancers, while expressing a similar
phenotype between different
individuals, have a diverse underlying
genetic basis for the disease. This
diverse genetic basis has implications
on the effective treatment of the various
phenotypes of lymphoma. For example,
a drug that was effective against one
individual’s phenotype of lymphoma
will not be effective against a similar
lymphoma in another individual. An
invention that helps clinicians classify a
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
lymphoproliferative disorder would
provide the basis for a
‘‘pharmacogenomic’’ method for treating
such cancers.
The present invention discloses a
novel microarray for obtaining gene
expression profile data to be used in
identifying lymphoma types and
predicting survival in a lymphoma
patient. The present invention further
discloses a variety of methods for
analyzing gene expression data obtained
from a lymphoma sample, and specific
algorithms for predicting survival and
clinical outcome in a subject suffering
from a lymphoma. The gene expression
profile data set was established using a
human genome gene chip set measuring
the expression of over 27,000 genes in
more than 500 lymphoproliferative
tumor samples collected from patients
at numerous healthcare institutions
worldwide.
This invention could be developed
into a useful pharmacogenomic,
diagnostic product. The number of
genes required for an accurate prognosis
is reduced almost ten-fold from the
human genome gene chip, allowing for
lower density microarray technology
and alternative gene expression
measuring platforms. The choice of the
gene set in this invention is optimized
to provide an all in one method for the
diagnosis of all lymphomas.
In addition to licensing, the
technology is available for further
development through collaborative
research with the inventors via a
Cooperative Research and Development
Agreement (CRADA).
HGC–1, a Gene Encoding a Member of
the Olfactomedin-Related Protein
Family
Griffin P. Rodgers, Wen-Li Liu, Jiachang
Zhang (NIDDK),
U.S. Provisional Patent Application 60/
338,759 filed 07 Dec 2001 (DHHS
Reference No. E–166–2001/0–US–01);
PCT Application No. PCT/US02/
39148 filed 09 Dec 2002, which
published as WO 03/050293 on 19 Jun
2003 (DHHS Reference No. E–166–
2001/0–PCT–02),
Licensing Contact: Brenda Hefti; (301)
435–4632; heftib@mail.nih.gov.
The current technology embodies a
newly identified gene, Human
Granulocyte Colony-Stimulating FactorStimulated-Clone-1 (hGC–1) that has
been cloned and characterized, and its
protein sequence has been deduced. The
gene is expressed in the bone marrow,
prostate, small intestine, colon, and
stomach, and has been mapped to
chromosome 13 in a region that contains
a tumor suppressor gene cluster. The
gene is found to be selectively present
E:\FR\FM\10MRN1.SGM
10MRN1
Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices
in normal human myeloid lineage cells
and is believed to play a role in
allowing lymphocytes to differentiate
properly. It is believed that the gene
may play a role in human prostate
cancer, multiple myeloma, B-cell
chronic lymphocytic leukemia and
other types of cancer and can be used
diagnostically as well as in therapeutic
screening activities.
Tyrosyl-DNA Phosphodiesterases (TDP)
and Related Polypeptides, Nucleic
Acids, Vectors, TDP-Producing Host
Cell, Antibodies and Methods of Use
Jeffrey J. Pouliot and Howard A. Nash
(NIMH),
U.S. Patent Application No. 10/110,176
filed 05 Apr 2002 (DHHS Reference
No. E–281–1999/0–US–03), claiming
priority to U.S. Provisional
Application No. 60/157,690 filed 05
Oct 1999 (DHHS Reference No. E–
281–1999/0–US–01),
Licensing Contact: John Stansberry;
(301) 451–7337;
stansbej@mail.nih.gov.
Topisomerases are cellular enzymes
that are vital for replication of the
genome. However, if topisomerase and
DNA form covalent complexes that
prevent the resealing of DNA, this may
lead to cell death. Essentially, this
invention consists of a new isolated and
cloned enzyme, tyrosyl-DNA
phospodiesterase (TDP1) that is capable
of hydrolyzing the covalent complexes
between topisomerase and DNA,
allowing the DNA to reseal. The
mechanism that defines topiosomerases
is their capacity to break DNA and, after
an interval in which topological changes
may occur, to reseal the break without
the intervention of a high-energy
cofactor. The breakage of the DNA is
accompanied by the formation of a
covalent bond between topisomerase
and DNA to create an intermediate that
is resolved during the resealing step.
However, if the resealing step fails, the
covalent intermediates between
topoisomerase I and DNA can form
complexes that lead to cell death. The
failure of the resealing is increased by
some chemotherapies such as
camptothecin. Thus, this technology has
many potential commercial uses
including: a method for screening
camptothecin analogues or other
compounds for their resistance to repair
by this enzyme or to prescreen patients
for their sensitivity to topoisomerase
inhibitors, which could identify patients
most likely to respond to camptothecin
therapy. Further, this invention
provides for a vector comprising of the
nucleic acid molecule for TDP1 as well
as the method of altering the level of
TDP1 in a cell, a tissue, an organ or an
VerDate jul<14>2003
18:28 Mar 09, 2005
Jkt 205001
organism. Finally, this invention
consists of a method for identifying a
compound that stabilizes a covalent
bond complex that forms between DNA
and topoisomerase I, wherein the
covalent bond cannot be cleaved.
Chromatin Insulator Protecting
Expressed Genes of Interest for Human
Gene Therapy or Other Mammalian
Transgenic Systems
Drs. Jay H. Chung and Gary Felsenfeld
(NIDDK),
U.S. Patent 5,610,053 issued 11 Mar
1997 (DHHS Reference No. E–206–
1992/1–US–01), Licensing Contact:
John Stansberry; (301) 435–5236;
stansbej@mail.nih.gov.
The technology provides the isolation
of a functional DNA sequence
comprising a chromatin insulating
element from a vertebrate system and
provides the first employment of the
pure insulator element as a functional
insulator in mammalian cells. The
technology further relates to a method
for insulating the expression of a gene
from the activity of cis-acting regulatory
sequences in eukaryotic chromatin.
This technology could be of major
importance in providing a mechanism
and a tool to restrict the action of cisacting regulatory elements on genes
whose activities or encoded products
are needed or desired to be expressed in
mammalian transgenic systems. This
technology provides the first pure
insulator element to function solely as
an insulator element in human cells.
Accordingly, this technology could have
tremendous practical implications for
transgenic technology and human gene
therapies, either in vitro or in vivo.
The technology further provides a
method and constructs for insulating the
expression of a gene or genes in
transgenic animals such that the
transfected genes will be protected and
stably expressed in the tissues of the
transgenic animal or its offspring. For
example, even if the DNA of the
construct integrates into areas of silent
chromatin in the genomic DNA of the
host animal, the gene will continue to
be expressed. The invention could
provide a means of improving the stable
integration and expression of any
transgenic construct of interest, with
efficiencies higher than are achieved
presently. Use of this invention may
represent a large potential savings for
licensee’s constructing transgenic cell
lines or animals.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
11997
Dated: March 2, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–4675 Filed 3–9–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meetings
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
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel, 05–59, Review F30s.
Date: March 30, 2005.
Time: 2 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Lynn M. King, PhD,
Scientific Review Administrator, Scientific
Review Branch, 45 Center Dr., Rm 4AN–38K,
National Institute of Dental & Craniofacial
Research, National Institutes of Health,
Bethesda, MD 20892–6402, (301) 594–5006.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel, 05–55, Review of R21s.
Date: April 11, 2005.
Time: 11 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Rebecca Roper, MS, MPH,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research, National Inst of Dental &
Craniofacial Research, National Institutes of
Health, 45 Center Dr., room 4AN32E,
Bethesda, MD 20892, (301) 451–5096.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel, 05–56, Review R21s.
E:\FR\FM\10MRN1.SGM
10MRN1
]]>Agencies
[Federal Register Volume 70, Number 46 (Thursday, March 10, 2005)]
[Notices]
[Pages 11995-11997]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4675]
-----------------------------------------------------------------------
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.
Dimer Inhibitory Peptides of CXCR4 as a Possible Novel Therapy for
Cancer
Jinhai Wang and Michael Norcross (FDA),
DHHS Reference No. E-037-2005/0--Research Tool,
Licensing Contact: John Stansberry; (301) 435-5236;
stansbej@mail.nih.gov.
This invention may control or inhibit cancer metastases by
targeting
[[Page 11996]]
chemokine receptor dimer formation. Specifically, this invention
relates to a synthetic peptide of the transmembrane region 4 (TM4) of
the Chemokine receptor (CXCR4). TM4 inhibits CXCR4 dimerization and
tumor cell migration. CXCR4 is highly expressed in human breast cancer
cells, prostate cancer, and pancreatic cancer. CXCR4 is involved in
breast cancer metastasis and tumor migration. Immunotherapies or
vaccinations based on blocking chemokine receptor dimerization with TM4
could be a useful treatment against proliferative diseases and cancer.
Carbohydrate-Encapsulated Gold Nanoparticles as Novel Anti-metastatic
Agents
Drs. Joseph Barchi (NCI), Sergei Svarovsky (NCI) et al.,
DHHS Reference No. E-001-2005/0-PCT-01,
Licensing Contact: John Stansberry; (301) 435-5236;
stansbej@mail.nih.gov.
The invention relates to the development of a new synthesis for the
tumor-associated, cell-surface carbohydrate moiety, known as the
Thomsen-Friedenrich T antigen. The inventors prepared a novel,
multivalent presentation platform by linking this disaccharide antigen
to the surface of gold nanoparticles and describe the application of
the multivalent system as an anti-adhesive tool to inhibit metastasis.
The glyconanoparticles principle described here has the potential to
integrate all the current knowledge and applications on processes that
involve carbohydrate molecules (inflammation, viral, bacterial, and
toxin infection, etc.). Administration of these nanoparticles into mice
bearing breast tumors was shown to inhibit lung metastases in this
model. This technology establishes the `` proof of principle'' for
possible biological applications of glyconanoparticles.
In addition to licensing, the technology is available for further
development through collaborative research with the inventors via a
Cooperative Research and Development Agreement (CRADA).
Methods for the Selection of Subjects for Multiple Sclerosis Therapy
Roland Martin et al. (NINDS),
International Application No. PCT/US04/10584 filed 05 Apr 2004 (DHHS
Reference No. E-005-2004/0-PCT-01),
Licensing Contact: Thomas Clouse; (301) 435-4076;
clousetp@mail.nih.gov.
Multiple Sclerosis (MS) is a life-long chronic autoimmune disease
diagnosed primarily in young adults who have a virtually normal life
expectancy. Estimates place the annual costs of MS in the United States
in excess of $2.5 billion. There are approximately 250,000 to 400,000
persons in the United States with MS, and approximately 2.5 million
persons worldwide suffer from MS. A variety of therapies are used to
treat MS, but there is no single therapy that can be used to treat all
patients. Furthermore, therapies that are currently approved for MS are
only moderately effective, and in some patients they have no effect at
all. The invention provides a method to determine if a patient with MS
will respond to a therapeutic protocol by analyzing the expression of
genes expressed by the immune system. For example, a single gene can be
assessed, or an expression profile of a patient can be created using an
array comprising gene sequences and analyzed to determine if the
patient will respond to one or more therapeutic protocols. A cDNA probe
constructed from mRNA of lymphocytes isolated from a patient can
hybridize with a microarray, and the extent of hybridization of the
probes to each gene on the microarray can be determined. The microarray
can include nucleic acid sequences encoding, for example, IL-8, Bcl-2-
interacting protein, dihydrofolate reductase, gyanylate-binding protein
1, interferon-induced 17 kDa protein, 2'5' OAS, plakoglobin, interferon
inducible proteinkinase, and STAT-1, among others.
Methods for Identifying, Diagnosing, and Predicting Survival of
Lymphomas
Louis M. Staudt et al. (NCI),
PCT Application No. PCT/US2004/029041 filed 03 Sep 2004 (DHHS Reference
No. E-234-2003/1-PCT-01) and U.S. Non-Provisional Patent Application
10/934,930 filed on 03 Sep 2004 (DHHS Reference No. E-108-2004/0-US-
01),
Licensing Contact: Jeff Walenta; (301) 435-4633; walentaj@mail.nih.gov.
Human lymphomas and leukemias are a diverse set of cancers. Many of
these cancers, while expressing a similar phenotype between different
individuals, have a diverse underlying genetic basis for the disease.
This diverse genetic basis has implications on the effective treatment
of the various phenotypes of lymphoma. For example, a drug that was
effective against one individual's phenotype of lymphoma will not be
effective against a similar lymphoma in another individual. An
invention that helps clinicians classify a lymphoproliferative disorder
would provide the basis for a ``pharmacogenomic'' method for treating
such cancers.
The present invention discloses a novel microarray for obtaining
gene expression profile data to be used in identifying lymphoma types
and predicting survival in a lymphoma patient. The present invention
further discloses a variety of methods for analyzing gene expression
data obtained from a lymphoma sample, and specific algorithms for
predicting survival and clinical outcome in a subject suffering from a
lymphoma. The gene expression profile data set was established using a
human genome gene chip set measuring the expression of over 27,000
genes in more than 500 lymphoproliferative tumor samples collected from
patients at numerous healthcare institutions worldwide.
This invention could be developed into a useful pharmacogenomic,
diagnostic product. The number of genes required for an accurate
prognosis is reduced almost ten-fold from the human genome gene chip,
allowing for lower density microarray technology and alternative gene
expression measuring platforms. The choice of the gene set in this
invention is optimized to provide an all in one method for the
diagnosis of all lymphomas.
In addition to licensing, the technology is available for further
development through collaborative research with the inventors via a
Cooperative Research and Development Agreement (CRADA).
HGC-1, a Gene Encoding a Member of the Olfactomedin-Related Protein
Family
Griffin P. Rodgers, Wen-Li Liu, Jiachang Zhang (NIDDK),
U.S. Provisional Patent Application 60/338,759 filed 07 Dec 2001 (DHHS
Reference No. E-166-2001/0-US-01); PCT Application No. PCT/US02/39148
filed 09 Dec 2002, which published as WO 03/050293 on 19 Jun 2003 (DHHS
Reference No. E-166-2001/0-PCT-02),
Licensing Contact: Brenda Hefti; (301) 435-4632; heftib@mail.nih.gov.
The current technology embodies a newly identified gene, Human
Granulocyte Colony-Stimulating Factor-Stimulated-Clone-1 (hGC-1) that
has been cloned and characterized, and its protein sequence has been
deduced. The gene is expressed in the bone marrow, prostate, small
intestine, colon, and stomach, and has been mapped to chromosome 13 in
a region that contains a tumor suppressor gene cluster. The gene is
found to be selectively present
[[Page 11997]]
in normal human myeloid lineage cells and is believed to play a role in
allowing lymphocytes to differentiate properly. It is believed that the
gene may play a role in human prostate cancer, multiple myeloma, B-cell
chronic lymphocytic leukemia and other types of cancer and can be used
diagnostically as well as in therapeutic screening activities.
Tyrosyl-DNA Phosphodiesterases (TDP) and Related Polypeptides, Nucleic
Acids, Vectors, TDP-Producing Host Cell, Antibodies and Methods of Use
Jeffrey J. Pouliot and Howard A. Nash (NIMH),
U.S. Patent Application No. 10/110,176 filed 05 Apr 2002 (DHHS
Reference No. E-281-1999/0-US-03), claiming priority to U.S.
Provisional Application No. 60/157,690 filed 05 Oct 1999 (DHHS
Reference No. E-281-1999/0-US-01),
Licensing Contact: John Stansberry; (301) 451-7337;
stansbej@mail.nih.gov.
Topisomerases are cellular enzymes that are vital for replication
of the genome. However, if topisomerase and DNA form covalent complexes
that prevent the resealing of DNA, this may lead to cell death.
Essentially, this invention consists of a new isolated and cloned
enzyme, tyrosyl-DNA phospodiesterase (TDP1) that is capable of
hydrolyzing the covalent complexes between topisomerase and DNA,
allowing the DNA to reseal. The mechanism that defines topiosomerases
is their capacity to break DNA and, after an interval in which
topological changes may occur, to reseal the break without the
intervention of a high-energy cofactor. The breakage of the DNA is
accompanied by the formation of a covalent bond between topisomerase
and DNA to create an intermediate that is resolved during the resealing
step. However, if the resealing step fails, the covalent intermediates
between topoisomerase I and DNA can form complexes that lead to cell
death. The failure of the resealing is increased by some chemotherapies
such as camptothecin. Thus, this technology has many potential
commercial uses including: a method for screening camptothecin
analogues or other compounds for their resistance to repair by this
enzyme or to prescreen patients for their sensitivity to topoisomerase
inhibitors, which could identify patients most likely to respond to
camptothecin therapy. Further, this invention provides for a vector
comprising of the nucleic acid molecule for TDP1 as well as the method
of altering the level of TDP1 in a cell, a tissue, an organ or an
organism. Finally, this invention consists of a method for identifying
a compound that stabilizes a covalent bond complex that forms between
DNA and topoisomerase I, wherein the covalent bond cannot be cleaved.
Chromatin Insulator Protecting Expressed Genes of Interest for Human
Gene Therapy or Other Mammalian Transgenic Systems
Drs. Jay H. Chung and Gary Felsenfeld (NIDDK),
U.S. Patent 5,610,053 issued 11 Mar 1997 (DHHS Reference No. E-206-
1992/1-US-01), Licensing Contact: John Stansberry; (301) 435-5236;
stansbej@mail.nih.gov.
The technology provides the isolation of a functional DNA sequence
comprising a chromatin insulating element from a vertebrate system and
provides the first employment of the pure insulator element as a
functional insulator in mammalian cells. The technology further relates
to a method for insulating the expression of a gene from the activity
of cis-acting regulatory sequences in eukaryotic chromatin.
This technology could be of major importance in providing a
mechanism and a tool to restrict the action of cis-acting regulatory
elements on genes whose activities or encoded products are needed or
desired to be expressed in mammalian transgenic systems. This
technology provides the first pure insulator element to function solely
as an insulator element in human cells. Accordingly, this technology
could have tremendous practical implications for transgenic technology
and human gene therapies, either in vitro or in vivo.
The technology further provides a method and constructs for
insulating the expression of a gene or genes in transgenic animals such
that the transfected genes will be protected and stably expressed in
the tissues of the transgenic animal or its offspring. For example,
even if the DNA of the construct integrates into areas of silent
chromatin in the genomic DNA of the host animal, the gene will continue
to be expressed. The invention could provide a means of improving the
stable integration and expression of any transgenic construct of
interest, with efficiencies higher than are achieved presently. Use of
this invention may represent a large potential savings for licensee's
constructing transgenic cell lines or animals.
Dated: March 2, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 05-4675 Filed 3-9-05; 8:45 am]
BILLING CODE 4140-01-P
