Government-Owned Inventions; Availability for Licensing, 38352-38353 [2013-15204]
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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
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meetings. Please visit our Web site at
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AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–15239 Filed 6–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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. 209 and 37 CFR part 404 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.
FOR FURTHER INFORMATION CONTACT:
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.
SUMMARY:
Predicting Age of Onset of NiemannPick Disease
Description of Technology: NiemannPick disease (NPD) refers to a group of
fatal inherited metabolic disorders.
Children with type A or B NPD usually
die within the first few months or years
of life, while NPD type C progresses
more slowly, and affected individuals
may survive into their seventies. The
lifespan of patients with NPD is related
to the age of onset. At present, however,
PO 00000
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there is no effective diagnostic method
to predict the age of NPD disease onset.
The instant invention presents
diagnostic compositions and efficient
methods for predicting the age of onset
of a lysosomal storage disease (e.g.,
NPD) and of diseases associated with
lysosomal of autophagic defects (e.g.,
Parkinson’s disease and Alzheimer’s
disease) in patients. It can also be used
to screen for agents useful in treating
NPD patients.
Potential Commercial Applications:
• Predicting the age of disease onset
in patients with Niemann-Pick disease,
and other diseases associated with
lysosomal or autophagic defects.
• Identifying agents for treating NPD
patients.
Competitive Advantages: A new
method for predicting the age of NPD
disease onset.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vitro data available.
Inventors: William J. Pavan, et al.
(NHGRI).
Intellectual Property: HHS Reference
No. E–060–2013/0—U.S. Provisional
Application No. 61/781,807 filed 14 Mar
2013.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity:
The National Human Genome Research
Institute (NHGRI) is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize diagnostic methods for
predicting the age of onset of lysosomal
disorders, such as NPD and Parkinson’s.
For collaboration opportunities, please
contact Dr. William J. Pavan at
bpavan@nhgri.nih.gov.
Rat Model for Alzheimer’s Disease
Description of Technology: The
present invention is directed to a
transgenic rat model of Alzheimer’s
Disease (AD) termed TgF344–19+/¥.
The invention rat overexpresses two
human genes (APPswe and PS1DE9
genes), each of which are believed to be
independent dominant causes of earlyonset AD. The hemizygote exhibits
major features of AD pathology (i.e.,
dense and diffuse amyloid plaques,
neurofibrillary tangles, cerebral amyloid
angiopathy, hyperphosphorylated tau,
paired-helical filaments, Hirano bodies,
granulovacuolar degeneration, cognitive
impairment, and cortical neuronal loss).
The invention rat is superior to AD
mice models because the rat has a larger
sized brain to accommodate in vivo
imaging studies and complex behavioral
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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
testing. Further, the invention rat has a
longer life span so that studies of longer
duration or studies involving serial
sampling can be conducted. The
invention rat can be used to evaluate
potential treatments for AD and to
further investigate AD physiology.
Potential Commercial Applications:
• In vivo validation of AD
therapeutics.
• Development and validation of
imaging methods to diagnose AD.
• Detailed investigation of AD
pathology and physiology.
Competitive Advantages:
• Rat model in contrast to available
mice models.
• Rat model based on over-expression
of genes responsible for early onset AD.
Development Stage:
• Prototype.
• In vivo data available (animal).
Inventors: Robert M. Cohen, et al.
(NIMH).
Publication: Borchelt DR, et al.
Familial Alzheimer’s disease-linked
presenilin 1 variants elevate Abeta1–42/
1–40 ratio in vitro and in vivo. Neuron.
1996 Nov; 17(5):1005–13. [PMID
8938131]
Intellectual Property: HHS Reference
No. E–211–2012/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
nguyenantczakla@mail.nih.gov.
Prognostic Biomarkers for Patients
With Early Stage Lung Cancer
Description of Technology:
Investigators at the National Cancer
Institute have discovered a set of
biomarkers that can identify patients
with early stage lung cancer who have
a high risk of relapse. Available for
licensing are prognostic assays based on
these biomarkers, which can enable
clinicians to select more effective
therapy and post-operative follow-up
strategies.
Surgery is the standard care for
patients with stage I lung cancer.
Despite successful surgery, 20–30% of
patients will relapse. Chemotherapy can
improve patient survival; however, it is
controversial if early stage cancer
patients should be treated with
chemotherapy since, for many cases, it
will harm quality of life with little
therapeutic benefit. Utilizing patient
samples, the investigators conducted a
retrospective study in eight patient
cohorts that validated the gene classifier
set. These prognostic methods can guide
physicians to select appropriate
treatment and follow-up while sparing
other patients of unnecessary treatment
and negative side-effects of
chemotherapy.
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20:26 Jun 25, 2013
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38353
Potential Commercial Applications:
• Method to determine the prognosis
of patients with lung cancer.
• Method to select more effective
treatment and post-operative follow-up
for patients with early stage lung cancer.
Competitive Advantages: Assays were
validated in human tissue samples and
eight different patient cohorts.
Development Stage:
• Early-stage.
• In vivo data available (human).
Inventors: Curt Harris (NCI), Aaron
Schetter (NCI), Ichiro Akagi (Nippon
Medical School), and Hirokazu
Okayama (Fukushima Medical
University).
Publication: Akagi I, et al.
Combination of protein coding and noncoding gene expression as a robust
prognostic classifier in stage I lung
adenocarcinoma. Cancer Res. 2013 May
2; Epub ahead of print. [PMID
23639940]
Intellectual Property: HHS Reference
No. E–048–2012/0—U.S. Provisional
Application No. 61/691,118 filed 20
Aug 2012.
Related Technology: HHS Reference
No. E–181–2006/0—U.S. Patent Nos.
7,943,318 and 8,377,637 and Australian
Patent No. 2007205234, and related
patent applications pending in
Australia, Canada, China, Europe, Japan
and the U.S.
Licensing Contact: Jennifer Wong,
M.S.; 301–435–4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize an early detection test for
lung cancer. For collaboration
opportunities, please contact John
Hewes, Ph.D. at hewesj@mail.nih.gov.
• Stem cell-based regenerative
medicine.
• Cancer therapeutic that targets
cancer stem cells.
Competitive Advantages: The
retroviral and lentiviral vectors in this
invention allow more selective control
of p53 activities than siRNA or mutant
p53 methods.
Development Stage: Early-stage.
Inventors: Curtis C. Harris (NCI) et al.
Intellectual Property: HHS Reference
No. E–239–2010/0—
• U.S. Provisional Patent Application
No. 61/389,134 filed 01 Oct 2010.
• International Patent Application
PCT/US2011/054304 filed 30 Sep 2011,
which published as WO/2012/044979
on 05 Apr 2012.
• Australian Patent Application
2011308567 filed 30 Sep 2011.
• US Patent Application No. 13/
877,100 filed 29 Mar 2013.
• Applications also pending in CA,
EP, JP (filing nos. unknown).
Related Technologies:
• HHS Reference No. E–033–2008/
0—Therapeutic Applications of a p53
Isoform in Regenerative Medicine,
Aging, and Cancer.
• HHS Reference No. E–137–2010/
0—Research Tool. Patent protection is
not being pursued for this technology.
Licensing Contact: Patrick McCue,
Ph.D.; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Human Carcinogenesis, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
Retroviral and Lentiviral Vectors. For
collaboration opportunities, please
contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Retroviral and Lentiviral Vectors To
Increase Efficiency of Inducible
Pluripotent Stem Cell (iPSC) Production
Description of Technology:
Researchers at the National Cancer
Institute have discovered that
modulating a specific p53 isoform
increases the number of inducible
pluripotent stem cells that can be
obtained from cells that are being reprogrammed to obtain pluripotent cells.
It is known that the activity of p53
regulates the self-renewal and
pluripotency of normal and cancer stem
cells, and also affects re-programming
efficiency of iPS cells. This p53 isoformbased technology provides a more
natural process of increasing iPS cell
production than previous methods of
decreasing p53.
Potential Commercial Applications:
Dated: June 20, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
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[FR Doc. 2013–15204 Filed 6–25–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
E:\FR\FM\26JNN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38352-38353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15204]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, 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. 209 and 37 CFR part 404 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.
FOR FURTHER INFORMATION CONTACT: 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.
Predicting Age of Onset of Niemann-Pick Disease
Description of Technology: Niemann-Pick disease (NPD) refers to a
group of fatal inherited metabolic disorders. Children with type A or B
NPD usually die within the first few months or years of life, while NPD
type C progresses more slowly, and affected individuals may survive
into their seventies. The lifespan of patients with NPD is related to
the age of onset. At present, however, there is no effective diagnostic
method to predict the age of NPD disease onset.
The instant invention presents diagnostic compositions and
efficient methods for predicting the age of onset of a lysosomal
storage disease (e.g., NPD) and of diseases associated with lysosomal
of autophagic defects (e.g., Parkinson's disease and Alzheimer's
disease) in patients. It can also be used to screen for agents useful
in treating NPD patients.
Potential Commercial Applications:
Predicting the age of disease onset in patients with
Niemann-Pick disease, and other diseases associated with lysosomal or
autophagic defects.
Identifying agents for treating NPD patients.
Competitive Advantages: A new method for predicting the age of NPD
disease onset.
Development Stage:
Early-stage.
Pre-clinical.
In vitro data available.
Inventors: William J. Pavan, et al. (NHGRI).
Intellectual Property: HHS Reference No. E-060-2013/0--U.S.
Provisional Application No. 61/781,807 filed 14 Mar 2013.
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity: The National Human Genome
Research Institute (NHGRI) is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize diagnostic methods for predicting
the age of onset of lysosomal disorders, such as NPD and Parkinson's.
For collaboration opportunities, please contact Dr. William J. Pavan at
bpavan@nhgri.nih.gov.
Rat Model for Alzheimer's Disease
Description of Technology: The present invention is directed to a
transgenic rat model of Alzheimer's Disease (AD) termed TgF344-19+/-.
The invention rat overexpresses two human genes (APPswe and
PS1[Delta]E9 genes), each of which are believed to be independent
dominant causes of early-onset AD. The hemizygote exhibits major
features of AD pathology (i.e., dense and diffuse amyloid plaques,
neurofibrillary tangles, cerebral amyloid angiopathy,
hyperphosphorylated tau, paired-helical filaments, Hirano bodies,
granulovacuolar degeneration, cognitive impairment, and cortical
neuronal loss).
The invention rat is superior to AD mice models because the rat has
a larger sized brain to accommodate in vivo imaging studies and complex
behavioral
[[Page 38353]]
testing. Further, the invention rat has a longer life span so that
studies of longer duration or studies involving serial sampling can be
conducted. The invention rat can be used to evaluate potential
treatments for AD and to further investigate AD physiology.
Potential Commercial Applications:
In vivo validation of AD therapeutics.
Development and validation of imaging methods to diagnose
AD.
Detailed investigation of AD pathology and physiology.
Competitive Advantages:
Rat model in contrast to available mice models.
Rat model based on over-expression of genes responsible
for early onset AD.
Development Stage:
Prototype.
In vivo data available (animal).
Inventors: Robert M. Cohen, et al. (NIMH).
Publication: Borchelt DR, et al. Familial Alzheimer's disease-
linked presenilin 1 variants elevate Abeta1-42/1-40 ratio in vitro and
in vivo. Neuron. 1996 Nov; 17(5):1005-13. [PMID 8938131]
Intellectual Property: HHS Reference No. E-211-2012/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; nguyenantczakla@mail.nih.gov.
Prognostic Biomarkers for Patients With Early Stage Lung Cancer
Description of Technology: Investigators at the National Cancer
Institute have discovered a set of biomarkers that can identify
patients with early stage lung cancer who have a high risk of relapse.
Available for licensing are prognostic assays based on these
biomarkers, which can enable clinicians to select more effective
therapy and post-operative follow-up strategies.
Surgery is the standard care for patients with stage I lung cancer.
Despite successful surgery, 20-30% of patients will relapse.
Chemotherapy can improve patient survival; however, it is controversial
if early stage cancer patients should be treated with chemotherapy
since, for many cases, it will harm quality of life with little
therapeutic benefit. Utilizing patient samples, the investigators
conducted a retrospective study in eight patient cohorts that validated
the gene classifier set. These prognostic methods can guide physicians
to select appropriate treatment and follow-up while sparing other
patients of unnecessary treatment and negative side-effects of
chemotherapy.
Potential Commercial Applications:
Method to determine the prognosis of patients with lung
cancer.
Method to select more effective treatment and post-
operative follow-up for patients with early stage lung cancer.
Competitive Advantages: Assays were validated in human tissue
samples and eight different patient cohorts.
Development Stage:
Early-stage.
In vivo data available (human).
Inventors: Curt Harris (NCI), Aaron Schetter (NCI), Ichiro Akagi
(Nippon Medical School), and Hirokazu Okayama (Fukushima Medical
University).
Publication: Akagi I, et al. Combination of protein coding and non-
coding gene expression as a robust prognostic classifier in stage I
lung adenocarcinoma. Cancer Res. 2013 May 2; Epub ahead of print. [PMID
23639940]
Intellectual Property: HHS Reference No. E-048-2012/0--U.S.
Provisional Application No. 61/691,118 filed 20 Aug 2012.
Related Technology: HHS Reference No. E-181-2006/0--U.S. Patent
Nos. 7,943,318 and 8,377,637 and Australian Patent No. 2007205234, and
related patent applications pending in Australia, Canada, China,
Europe, Japan and the U.S.
Licensing Contact: Jennifer Wong, M.S.; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
an early detection test for lung cancer. For collaboration
opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov.
Retroviral and Lentiviral Vectors To Increase Efficiency of Inducible
Pluripotent Stem Cell (iPSC) Production
Description of Technology: Researchers at the National Cancer
Institute have discovered that modulating a specific p53 isoform
increases the number of inducible pluripotent stem cells that can be
obtained from cells that are being re-programmed to obtain pluripotent
cells. It is known that the activity of p53 regulates the self-renewal
and pluripotency of normal and cancer stem cells, and also affects re-
programming efficiency of iPS cells. This p53 isoform-based technology
provides a more natural process of increasing iPS cell production than
previous methods of decreasing p53.
Potential Commercial Applications:
Stem cell-based regenerative medicine.
Cancer therapeutic that targets cancer stem cells.
Competitive Advantages: The retroviral and lentiviral vectors in
this invention allow more selective control of p53 activities than
siRNA or mutant p53 methods.
Development Stage: Early-stage.
Inventors: Curtis C. Harris (NCI) et al.
Intellectual Property: HHS Reference No. E-239-2010/0--
U.S. Provisional Patent Application No. 61/389,134 filed
01 Oct 2010.
International Patent Application PCT/US2011/054304 filed
30 Sep 2011, which published as WO/2012/044979 on 05 Apr 2012.
Australian Patent Application 2011308567 filed 30 Sep
2011.
US Patent Application No. 13/877,100 filed 29 Mar 2013.
Applications also pending in CA, EP, JP (filing nos.
unknown).
Related Technologies:
HHS Reference No. E-033-2008/0--Therapeutic Applications
of a p53 Isoform in Regenerative Medicine, Aging, and Cancer.
HHS Reference No. E-137-2010/0--Research Tool. Patent
protection is not being pursued for this technology.
Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Laboratory of Human Carcinogenesis, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate or commercialize Retroviral and Lentiviral
Vectors. For collaboration opportunities, please contact John D. Hewes,
Ph.D. at hewesj@mail.nih.gov.
Dated: June 20, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-15204 Filed 6-25-13; 8:45 am]
BILLING CODE 4140-01-P
