Government-Owned Inventions; Availability for Licensing, 4569-4570 [2010-1667]
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4569
Federal Register / Vol. 75, No. 18 / Thursday, January 28, 2010 / Notices
In addition to questions required for
registration, there will be a series of
short surveys to collect information on
such things as military history,
occupations, and family history that
would not likely be available from other
sources.
This project proposes to collect
information on individuals with ALS
which can be combined with
information obtained from existing
sources of information. This combined
data will become the National ALS
Registry and will be used to provide
more accurate estimates of the incidence
and prevalence of disease as well as the
demographic characteristics of the
cases. Information obtained from the
surveys will be used to better
characterize potential risk factors for
ALS which will lead to further in-depth
studies.
The existence of the Web site will be
advertised by ATSDR and advocacy
groups such as the Amyotrophic Lateral
Sclerosis Association (ALSA) and the
Muscular Dystrophy Association
(MDA). There are no costs to the
respondents other than their time. The
estimated annualized burden hours are
2300.
ESTIMATED ANNUALIZED BURDEN HOURS
Forms for ALS
respondents
Validation questions .........................................................................................................
Registration of ALS cases ...............................................................................................
Cases of ALS completing 1-time surveys .......................................................................
Cases of ALS completing twice yearly surveys ..............................................................
Dated: January 22, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention, Agency for
Toxic Substances and Disease Registry.
[FR Doc. 2010–1718 Filed 1–27–10; 8:45 am]
BILLING CODE 4163–18–P
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.
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.
mstockstill on DSKH9S0YB1PROD with NOTICES
ADDRESSES:
VerDate Nov<24>2008
17:16 Jan 27, 2010
Jkt 220001
Diagnostic Tool for Diagnosing Benign
Versus Malignant Thyroid Lesions
Description of Invention: This
technology describes a 72 gene model
that has been developed for diagnosing
less common forms of thyroid cancer
like follicular carcinoma and others.
The technology detects thyroid cancer
using fine needle aspiration (FNA)
biopsy and the analysis of differentially
expressed thyroid (DET) genes and their
encoded proteins. These results provide
a molecular classification system for
thyroid tumors and this in turn provides
a more accurate diagnostic tool for the
clinician managing patients with
suspicious thyroid lesions. It is related
to earlier technology out of the
laboratory of Dr. Libutti, US Application
No. 11/547,995 entitled ‘‘Diagnostic
Tool for Diagnosing Benign vs.
Malignant Thyroid Lesions’’ (HHS
Reference No. E–124–2004). This latter
invention was drawn to a 6 and 10 gene
model that distinguishes benign vs.
malignant papillary thyroid lesions.
Application: The identification of
markers that can determine a specific
type of tumor, predict patient outcome
or the tumor response to specific
therapies.
Advantage: The use of gene profiles to
detect thyroid malignancy has the
advantage that it complements the
current method of diagnosis using FNA,
but greatly increases the accuracy of
detecting malignant thyroid lesions.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market: It is expected that more than
37,340 new cases of thyroid cancer will
be diagnosed in the United States this
year. Women will be disproportionately
affected constituting 76% of these new
PO 00000
Number of
responses per
respondent
Number of
respondents
Frm 00047
Fmt 4703
Sfmt 4703
6,000
4,667
2,334
2,334
Average burden
per response
(in hours)
1
1
6
2
2/60
7/60
5/60
5/60
cases. Fortunately, this is one of the
least deadly cancers; the percentage of
people living at least 5 years after being
diagnosed is about 97%. However,
current methods of diagnosis are
inaccurate and many biopsy results are
inconclusive and labeled as suspicious
or indeterminate because of difficulties
in distinguishing benign and malignant
thyroid tumors solely on cellular
features. Since most nodules usually
end up being benign, treatment
decisions are greatly impacted because
patients with benign nodules may be
subjected to unnecessary surgery that
will impact their lives considerably.
Thus, there is a compelling need to
develop more accurate diagnostic tests
to detect thyroid cancer.
Inventors: Steven K. Libutti (NCI) et
al.
Related Publications:
1. Prasad NB, Somervell H, Tufano
RP, Dackiw AP, Marohn MR, Califano
JA, Wang Y, Westra WH, Clark DP,
Umbricht CB, Libutti SK, Zeiger MA.
Identification of genes differentially
expressed in benign versus malignant
thyroid tumors. Clin Cancer Res. 2008
Jun 1;14(11):3327–3337. [PubMed:
18519760]
2. Rosen J, He M, Umbricht C,
Alexander HR, Dackiw AP, Zeiger MA,
Libutti SK. A six-gene model for
differentiating benign from malignant
thyroid tumors on the basis of gene
expression. Surgery. 2005
Dec;138(6):1050–1056; discussion 1056–
1057. [PubMed: 16360390]
3. Mazzanti C, Zeiger MA, Costouros
NG, Umbricht C, Westra WH, Smith D,
Somervell H, Bevilacqua G, Alexander
HR, Libutti SK. Using gene expression
profiling to differentiate benign versus
malignant thyroid tumors. Cancer Res.
E:\FR\FM\28JAN1.SGM
28JAN1
4570
Federal Register / Vol. 75, No. 18 / Thursday, January 28, 2010 / Notices
2004 Apr 15;64(8):2898–2903. [PubMed:
15087409]
Patent Status: PCT Application No.
PCT/US2008/10139 entitled ‘‘Diagnostic
Tool for Diagnosing Benign Versus
Malignant Thyroid Lesions’’ filed
August 27, 2008 (HHS Reference No.
E–326–2007/0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research, Surgery
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Diagnostic Tool for
Diagnosing Benign Versus Malignant
Thyroid Lesions. Please contact John D.
Hewes, Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
mstockstill on DSKH9S0YB1PROD with NOTICES
Imaging of Extracellular Proteases in
Cells Using Mutant Anthrax Toxin
Protective Antigens
Description of Invention: The claimed
invention provides highly specific and
sensitive methods for in vivo, in vitro,
or ex vivo imaging of specific
extracellular protease activity using an
anthrax binary toxin system. The system
targets cells that express extracellular
proteases of interest. Such a system
would be highly useful since various
studies have demonstrated a positive
correlation between the activity of
extracellular proteases and various
diseases and undesirable physiological
conditions. For example, breakdown of
the extracellular matrix by extracellular
proteases is a prerequisite for the
invasive growth of malignant cells,
metastatic spread of tumors, and other
pathological remodeling of tissue. In
this case, methods are provided for the
imaging of a specific extracellular
protease by contacting a cell with: (1) A
mutant anthrax toxin protective antigen
(mPrAg) that binds to a cell surface
receptor of a cell expressing an
extracellular protease and is cleaved by
a specific extracellular protease
expressed by the cell and 2) a ligand
that specifically binds to the cleaved
mPrAg and is linked to a moiety that is
detected by an imaging procedure,
thereby forming a ligand-mPrAg
complex that is translocated into the
cell. The detectable moiety linked to the
ligand in the ligand-mPrAg complex can
be imaged before, during, or after
translocation. Specific disease examples
might include, but are not necessarily
limited to, cancer, inflammation, and
tumor progression or regression.
VerDate Nov<24>2008
17:16 Jan 27, 2010
Jkt 220001
Inventors: Thomas H. Bugge et al.
(NIDCR).
Patent Status: U.S. Patent Application
No. 10/488,806 filed 04 Mar 2004 (HHS
Reference No. E–295–2001/0–US–03).
Licensing Status: Available for
licensing.
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
A Basal Cell Carcinoma Tumor
Suppressor Gene
Description of Invention: Novel
human nucleic acid sequences and
polypeptides derived from the tumor
suppressor, PTC or patched gene which
have been mapped to human
chromosome 9q22.3-q31, have been
discovered for use in cancer diagnosis
and therapy. Mutations of this gene are
associated with Nevoid Basal Cell
Carcinoma Syndrome (NBCCS) a disease
associated with skin cancer and human
developmental defects such as Gorlin
Syndrome comprising skeletal defects,
craniofacial and brain abnormalities.
Methods of detection of PTC in a tissue
sample have been found as well as
recombinant cells, antibodies, and
pharmacological compositions useful in
treatment of the disease. Methods of
diagnosis of and therapy for NBCCS
have also been found. The PTC gene is
thought to encode a protein which
selectively switches off growth factor
production in certain cells by
interaction with members of the family
of proteins encoded by the ‘‘hedgehog’’
gene, which instructs cells during
development and growth. NBCCS is the
result of abnormal PTC gene products
that encode non-functional or
functionally reduced NBCCS
polypeptides. This lack of function may
be caused by insertions, deletions, point
mutations, splicing errors, premature
termination codons, missing initiators,
etc. The tumors caused by NBCCS are
slow growing tumors that rarely
metastasize, but which can cause
significant morbidity and occasional
mortality from local invasion. The PTC
gene is also associated with
medulloblastomas and
trichoepitheliomas.
Newly discovered germline and
sporadic mutations associated with
NBCCS have been disclosed and
claimed in the International (PCT)
application.
Inventors: Michael C. Dean (NCI) et al.
Patent Status:
• U.S. Patent No. 6,552,181 issued 22
Apr 2003 (HHS Reference No. E–104–
1996/1–US–01).
• U.S. Patent No. 7,317,086 issued 08
Jan 2008 (HHS Reference No. E–104–
1996/1–US–02).
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
• Related international patents/patent
applications.
Licensing Status: Available for
licensing.
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–1667 Filed 1–27–10; 8:45 am]
BILLING CODE 4140–01–P
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.
Signal-to-Noise Enhancement in
Imaging Applications Using a TimeSeries of Images
Description of Invention: The
invention offered for licensing relates to
the field of imaging and specifically to
the field of medical imaging. The
apparatus and method of the invention
provide for noise reduction in imaging
applications that use a time-series of
images. In one embodiment of the
invention, a time-series of images is
acquired using a same imaging protocol
of the same subject area, but the images
are spaced in time by one or more time
intervals (e.g. 1, 2, 3 * * * seconds
apart). A sub-region is projected across
E:\FR\FM\28JAN1.SGM
28JAN1
]]>Agencies
[Federal Register Volume 75, Number 18 (Thursday, January 28, 2010)]
[Notices]
[Pages 4569-4570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1667]
-----------------------------------------------------------------------
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.
Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions
Description of Invention: This technology describes a 72 gene model
that has been developed for diagnosing less common forms of thyroid
cancer like follicular carcinoma and others. The technology detects
thyroid cancer using fine needle aspiration (FNA) biopsy and the
analysis of differentially expressed thyroid (DET) genes and their
encoded proteins. These results provide a molecular classification
system for thyroid tumors and this in turn provides a more accurate
diagnostic tool for the clinician managing patients with suspicious
thyroid lesions. It is related to earlier technology out of the
laboratory of Dr. Libutti, US Application No. 11/547,995 entitled
``Diagnostic Tool for Diagnosing Benign vs. Malignant Thyroid Lesions''
(HHS Reference No. E-124-2004). This latter invention was drawn to a 6
and 10 gene model that distinguishes benign vs. malignant papillary
thyroid lesions.
Application: The identification of markers that can determine a
specific type of tumor, predict patient outcome or the tumor response
to specific therapies.
Advantage: The use of gene profiles to detect thyroid malignancy
has the advantage that it complements the current method of diagnosis
using FNA, but greatly increases the accuracy of detecting malignant
thyroid lesions.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market: It is expected that more than 37,340 new cases of thyroid
cancer will be diagnosed in the United States this year. Women will be
disproportionately affected constituting 76% of these new cases.
Fortunately, this is one of the least deadly cancers; the percentage of
people living at least 5 years after being diagnosed is about 97%.
However, current methods of diagnosis are inaccurate and many biopsy
results are inconclusive and labeled as suspicious or indeterminate
because of difficulties in distinguishing benign and malignant thyroid
tumors solely on cellular features. Since most nodules usually end up
being benign, treatment decisions are greatly impacted because patients
with benign nodules may be subjected to unnecessary surgery that will
impact their lives considerably. Thus, there is a compelling need to
develop more accurate diagnostic tests to detect thyroid cancer.
Inventors: Steven K. Libutti (NCI) et al.
Related Publications:
1. Prasad NB, Somervell H, Tufano RP, Dackiw AP, Marohn MR,
Califano JA, Wang Y, Westra WH, Clark DP, Umbricht CB, Libutti SK,
Zeiger MA. Identification of genes differentially expressed in benign
versus malignant thyroid tumors. Clin Cancer Res. 2008 Jun
1;14(11):3327-3337. [PubMed: 18519760]
2. Rosen J, He M, Umbricht C, Alexander HR, Dackiw AP, Zeiger MA,
Libutti SK. A six-gene model for differentiating benign from malignant
thyroid tumors on the basis of gene expression. Surgery. 2005
Dec;138(6):1050-1056; discussion 1056-1057. [PubMed: 16360390]
3. Mazzanti C, Zeiger MA, Costouros NG, Umbricht C, Westra WH,
Smith D, Somervell H, Bevilacqua G, Alexander HR, Libutti SK. Using
gene expression profiling to differentiate benign versus malignant
thyroid tumors. Cancer Res.
[[Page 4570]]
2004 Apr 15;64(8):2898-2903. [PubMed: 15087409]
Patent Status: PCT Application No. PCT/US2008/10139 entitled
``Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid
Lesions'' filed August 27, 2008 (HHS Reference No. E-326-2007/0-PCT-
02).
Licensing Status: Available for licensing.
Licensing Contact: Whitney Hastings; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Surgery Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize Diagnostic Tool for Diagnosing Benign Versus
Malignant Thyroid Lesions. Please contact John D. Hewes, Ph.D. at 301-
435-3121 or hewesj@mail.nih.gov for more information.
Imaging of Extracellular Proteases in Cells Using Mutant Anthrax Toxin
Protective Antigens
Description of Invention: The claimed invention provides highly
specific and sensitive methods for in vivo, in vitro, or ex vivo
imaging of specific extracellular protease activity using an anthrax
binary toxin system. The system targets cells that express
extracellular proteases of interest. Such a system would be highly
useful since various studies have demonstrated a positive correlation
between the activity of extracellular proteases and various diseases
and undesirable physiological conditions. For example, breakdown of the
extracellular matrix by extracellular proteases is a prerequisite for
the invasive growth of malignant cells, metastatic spread of tumors,
and other pathological remodeling of tissue. In this case, methods are
provided for the imaging of a specific extracellular protease by
contacting a cell with: (1) A mutant anthrax toxin protective antigen
(mPrAg) that binds to a cell surface receptor of a cell expressing an
extracellular protease and is cleaved by a specific extracellular
protease expressed by the cell and 2) a ligand that specifically binds
to the cleaved mPrAg and is linked to a moiety that is detected by an
imaging procedure, thereby forming a ligand-mPrAg complex that is
translocated into the cell. The detectable moiety linked to the ligand
in the ligand-mPrAg complex can be imaged before, during, or after
translocation. Specific disease examples might include, but are not
necessarily limited to, cancer, inflammation, and tumor progression or
regression.
Inventors: Thomas H. Bugge et al. (NIDCR).
Patent Status: U.S. Patent Application No. 10/488,806 filed 04 Mar
2004 (HHS Reference No. E-295-2001/0-US-03).
Licensing Status: Available for licensing.
Licensing Contact: Whitney Hastings; 301-451-7337;
hastingw@mail.nih.gov.
A Basal Cell Carcinoma Tumor Suppressor Gene
Description of Invention: Novel human nucleic acid sequences and
polypeptides derived from the tumor suppressor, PTC or patched gene
which have been mapped to human chromosome 9q22.3-q31, have been
discovered for use in cancer diagnosis and therapy. Mutations of this
gene are associated with Nevoid Basal Cell Carcinoma Syndrome (NBCCS) a
disease associated with skin cancer and human developmental defects
such as Gorlin Syndrome comprising skeletal defects, craniofacial and
brain abnormalities. Methods of detection of PTC in a tissue sample
have been found as well as recombinant cells, antibodies, and
pharmacological compositions useful in treatment of the disease.
Methods of diagnosis of and therapy for NBCCS have also been found. The
PTC gene is thought to encode a protein which selectively switches off
growth factor production in certain cells by interaction with members
of the family of proteins encoded by the ``hedgehog'' gene, which
instructs cells during development and growth. NBCCS is the result of
abnormal PTC gene products that encode non-functional or functionally
reduced NBCCS polypeptides. This lack of function may be caused by
insertions, deletions, point mutations, splicing errors, premature
termination codons, missing initiators, etc. The tumors caused by NBCCS
are slow growing tumors that rarely metastasize, but which can cause
significant morbidity and occasional mortality from local invasion. The
PTC gene is also associated with medulloblastomas and
trichoepitheliomas.
Newly discovered germline and sporadic mutations associated with
NBCCS have been disclosed and claimed in the International (PCT)
application.
Inventors: Michael C. Dean (NCI) et al.
Patent Status:
U.S. Patent No. 6,552,181 issued 22 Apr 2003 (HHS
Reference No. E-104-1996/1-US-01).
U.S. Patent No. 7,317,086 issued 08 Jan 2008 (HHS
Reference No. E-104-1996/1-US-02).
Related international patents/patent applications.
Licensing Status: Available for licensing.
Licensing Contact: Whitney Hastings; 301-451-7337;
hastingw@mail.nih.gov.
Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-1667 Filed 1-27-10; 8:45 am]
BILLING CODE 4140-01-P
