Government-Owned Inventions; Availability for Licensing, 3437-3440 [2013-00738]
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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices
reporting is launched, CTP estimates
that it will receive, on average, 100
voluntary adverse event and product
problem reports annually over the next
3 years. Thus, FDA estimates that over
the next 3 years it will receive annually
1,513 voluntary adverse event reports
submitted via the SRP, with a burden of
907.8 hours, rounded to 908 hours, as
reported in table 2, row 1 (1,413 + 100
= 1,513).
Mandatory adverse event reports
submitted via the SRP (other than RFR
Reports) include reports of adverse
animal drug experiences and product/
manufacturing defects associated with
approved NADAs and ANADAs. CVM
received 144 such adverse event reports
in 2010, 537 reports in 2011, and 212
reports in the first four months of 2012,
and estimates that for the full 12 months
of 2012 it will receive 636 reports.
Based on this experience, CVM
estimates that it will receive, on average,
636 reports of adverse drug experiences
and product/manufacturing defects
associated with approved NADAs and
ANADAs annually over the next 3 years.
Thus, FDA estimates that over the next
3 years it will receive annually 636
mandatory adverse event reports
submitted via the SRP, with a burden of
636 hours, as reported in table 2, row 2.
Adverse event reports submitted via
the ESG include reports of adverse
experiences related to drugs, biological
products, and medical devices, as well
as, adverse animal drug experiences and
product/manufacturing defects
associated with approved NADAs and
ANADAs. FDA received 586,229 such
adverse event reports in 2010; 850,161
reports in 2011; and 497,076 reports in
the first 4 months of 2012; and estimates
that for the full 12 months of 2012 it
will receive 1,491,228 reports. Based on
this experience, FDA estimates that it
will receive, on average, 1,491,228
adverse event reports submitted via the
ESG, with a burden of 894,736.8 hours,
rounded to 894,737 hours, as reported
in table 2, row 3.
FDA estimates that over the next 3
years it will receive annually 1,413
mandatory and voluntary RFR Reports
submitted via the SRP, as reported in
table 2, row 4. The Center for Food
Safety and Applied Nutrition (CFSAN)
received 845 such adverse event reports
in 2010; 1,293 reports in 2011; and 471
reports in the first four months of 2012;
and estimates that for the full 12 months
of 2012 it will receive 1,413 reports.
Based on this experience, CFSAN
estimates that it will receive, on average,
1,413 mandatory and voluntary RFR
Reports submitted via the SRP annually
over the next 3 years, with a burden of
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847.8 hours, rounded to 848 hours, as
reported in table 2, row 4.
The burden hours required to
complete paper FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and
1932a) are reported under OMB control
numbers 0910–0284 and 0910–0291.
While FDA does not charge for the
use of the ESG, FDA requires
respondents to obtain a public key
infrastructure certificate in order to set
up the account. This can be obtained inhouse or outsourced by purchasing a
public key certificate that is valid for 1
year to 3 years. The certificate typically
costs from $20 to $30.
Dated: January 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–00761 Filed 1–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
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:
Optical Microscope Software for Breast
Cancer Diagnosis
Description of Technology: The
instant invention discloses a software to
analyze optical microscopic images of
human breast tissue sections for
diagnosing cancer by using the
differences in spatial positioning of
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certain genes. The software uses the
inherent hierarchy in the data and stores
all the analysis and manual interaction
information in a highly structured XML
file. It is a user-friendly software to
discriminate normal and cancerous
human breast tissue section images that
can be used for large experiments.
Additionally the software uses a cluster
of computers in the background to
reduce the analysis time for large image
datasets. Furthermore, the software of
instant invention provides a set of tools
for performing diagnostic or prognostic
assays on new unseen datasets.
Potential Commercial Applications:
• The software could be an essential
part of an integrated diagnostic or
prognostic assay for breast cancer
detection.
• The software could be a key tool for
biomedical research to test new markers
and their applicability for diagnostic
purposes.
• The use of the software could
provide important information for
understanding the underlying causes of
gene repositioning.
Competitive Advantages:
• The software of instant invention
can be used to analyze relatively large
datasets.
• To reduce the processing time by at
least 10 fold.
• The software can be used in a broad
range of quantitative image analysis
applications.
Development Stage:
• Prototype
• Clinical
• In vitro data available (human)
Inventors: Kaustav Nandy (SAICFrederick, Inc), Stephen J. Lockett
(SAIC-Frederick, Inc), Prabhakar R.
Gudla (SAIC-Frederick, Inc), William
Cukierski (NCI), Renee Qian (NCI),
Karen J. Meaburn (NCI), Tom Misteli
(NCI).
Publications:
1. Gudla PR, et al. A high-throughput
system for segmenting nuclei using
multiscale techniques. Cytometry A.
2008 May;73(5):451–66. [PMID
18338778]
2. Nandy K, et al. Automatic nuclei
segmentation and spatial FISH analysis
for cancer detection. Conf Proc IEEE Eng
Med Biol Soc. 2009;2009:6718–21.
[PMID 19963931].
3. Meaburn KJ, et al. Disease-specific
gene repositioning in breast cancer. J
Cell Biol. 2009 Dec 14;187(6):801–12.
[PMID 19995938].
4. Cukierski WJ, et al. Ranked
retrieval of segmented nuclei for
objective assessment of cancer gene
repositioning. BMC Bioinformatics.
2012 Sep 12;13:232. [PMID: 22971117].
5. Nandy K, et al. Supervised learning
framework for screening nuclei in tissue
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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices
sections. Conf Proc IEEE Eng Med Biol
Soc. 2011;2011:5989–92. [PMID
22255704]
Intellectual Property: HHS Reference
No. E–286–2012/0—Software. Patent
protection is not being pursued for this
technology.
Licensing Contact: Susan Ano, Ph.D.;
301–435–5515; anos@mail.nih.gov.
Collaborative Research Opportunity:
The SAIC-Frederick Optical Microscopy
and Analysis Laboratory is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact John Hewes, Ph.D., at
hewesj@mail.nih.gov.
mstockstill on DSK4VPTVN1PROD with
Simple Direct Zirconium-89 Cell PET
Label, 89Zr-Labeled Cells, and Methods
for Real-Time In Vivo Pet Imaging
Description of Technology: The
capability to image cells and cellular
processes in real time over a scale of
days could dramatically improve
research insights and the effectiveness
of cell-based therapies. Zirconium-89
(89Zr) has a half-life of over three days
(78.4 hours) over 44 times longer
compared to Fluorine (18F) the most
commonly used PET isotope (half-life of
1 hour and 50 minutes). 89Zr is also
advantageous compared to other long
half-life isotopes because it is not
limited by high background activity and
cell toxicity. Labeling cells with 89Zr, is
currently accomplished by indirect
methods using secondary cell-type
specific reagents such as antibodies.
This technology is a PET imaging
complex of 89Zr and polycation that is
internalized by the cells. This complex
has been able to directly label a wide
range of cells, without the use of
secondary reagents. 89Zr-labeled cells of
lymphocytic lineage, including T cells,
natural killer T-cells, macrophages,
dendritic cells, and stem cells, have
been produced and imaged in vivo with
minimal damage to the cells. This PET
imaging agent can be readily combined
with an MR imaging agent for combined
PET/MR imaging of cells. The imaging
capabilities enabled by this technology
may significantly improve cell
therapies, cell level diagnostics and aid
research for non-cell based therapies.
Potential Commercial Applications:
• Imaging
• Diagnostic
• Cell therapies
• Transplantation and transfusion
Competitive Advantages:
• Direct labeled cells (versus indirect
techniques)
• Longer half-life
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• Not limited by high background
activity and cell toxicity
Development Stage:
• Early-stage
• Pre-clinical
• In vivo data available (animal)
Inventors: Omer Aras (CC), Peter
Choyke (NCI), Joseph Frank (CC),
Noriko Sato (CC), Jeremy Pantin
(NHLBI).
Intellectual Property: HHS Reference
No. E–056–2012/0—US Provisional
Application No. 61/611964 filed 16 Mar
2012.
Licensing Contact: Tedd Fenn; 301–
435–5031; Tedd.Fenn@nih.gov
Collaborative Research Opportunity:
The NCI is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact John Hewes, Ph.D., at
hewesj@mail.nih.gov.
Small, Stable, Functional, Soluble,
Monomeric IgG1 Fc Molecules
Engineered Therapies
Description of Technology: This
technology relates to small (∼27 kDa)
antibody fragments that are potentially
useful for therapeutic development.
These are monomeric IgG fragment
crystalizable (mFc) compositions; they
are long half-lived, functional (pH
dependent binders of neonatal Fc
receptor—FcRn); and they are soluble
and express efficiently in E. coli. These
molecules may serve as a platform for
development of engineered mFc-based
antibodies and fusion proteins with
therapeutic applications. Efforts to
engineer antibody-based therapeutics, to
date, have encountered technical
limitations due to the relatively large
fragment size and short fragment halflife. The IgG fragment crystalizable (Fc)
is a dimer of two constant domains
(CH2–CH3 chains). Fc has a long halflife, which makes it promising as a
candidate for engineering antibody
therapeutics. Fusion proteins based on
Fc dimer molecules demonstrate
extended half-life, due to the ability to
bind FcRn at acidic pH. However, the
relatively large size of the Fc domains
(∼50 kD) is not optimal. This technology
uses smaller (∼27 kDa) mFc
compositions that retain efficient
binding to human FcRn and
demonstrate long half-life. These mFc
compositions are promising for the
development of novel therapeutics
because the smaller size may allow for
superior access to targets and tissues
compared to full sized mAbs and larger
fragment-based therapeutics, while also
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retaining important function
characteristics.
Potential Commercial Applications:
Therapeutics—human and veterinary,
engineered antibody and fusion
proteins.
Competitive Advantages: Smaller size
results better tissue penetration,
reduced steric hindrance, increased
therapeutic efficiency and lower cost.
Development Stage:
• Early-stage
• Pre-clinical
Inventors: Dimiter S. Dimitrov and
Tianlei Ying (NCI).
Publication: Ying T, et al. Soluble
monomeric IgG1 Fc. J Biol Chem. 2012
Jun 1; 287(23):19399–408. [PMID
22518843].
Intellectual Property: HHS Reference
No. E–019–2012/0—U.S. Patent
Application No. 61/612,138 filed 16 Mar
2012.
Related Technologies: HHS Reference
No. E–003–2007/0—
• U.S. Patent Application No. 61/
063,245 filed 31 Jan 2008
• PCT Application No. PCT/US2009/
0326 and related international
applications filed on 30 Jan 2009 in
Australia, Canada, China, Europe, Japan,
and India
• U.S. Patent Application No. 12/
864,758 filed 27 Jul 2010
Licensing Contact: Tedd Fenn; 301–
435–5031; Tedd.Fenn@nih.gov
Collaborative Research Opportunity:
The NCI/CCR/NP is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize Small, Stable,
Functional, Soluble, Monomeric IgG1 Fc
Molecules Engineered Therapies. For
collaboration opportunities, please
contact John Hewes, Ph.D., at
#hewesj@mail.nih.gov.
Virus-Like Particles Mediated Protein
and RNA Delivery
Description of Technology: The
invention is directed to novel virus-like
particles (VLPs) that are capable of
binding to and replicating within a
target mammalian cell, including
human cells. The claimed VLPs are safer
than viral delivery because they are
incapable of re-infecting target cells.
The present VLPs can optionally
comprise inhibitory recombinant
polynucleotides, such as microRNA,
antisense RNA or small hairpin RNA, to
down regulate or turn off expression of
a particular gene within the target cell.
Alternatively, recombinant
polynucleotides packaged within VLPs
can comprise a gene encoding a
therapeutic protein so as to enable
expression of that protein within the
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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices
target cell. Specifically, VLPs of the
invention are composed of an
alphavirus replicon that contains a
recombinant polynucleotide, a retroviral
gag protein, and a fusogenic envelope
glycoprotein.
While the claimed VLPs have a
variety of applications, therapeutic uses
of the VLPs include directing antibody
synthesis and converting cancer cells
into antigen presenting cells. Additional
applications include using VLPs to
induce fast (approx. 3–4 hrs) and high
levels of protein production in
mammalian cells.
Potential Commercial Applications:
• Delivery of microRNA and small
hairpin RNA to reduce express of
targeted genes in a human cell
• Delivery of coding RNA for robust
expression in mammalian systems
• Direct antibody production by in
vivo injection of replicons (no antigen
purification)
• Therapeutic applications
Competitive Advantages:
• High level (∼million copies per cell)
of RNA production/synthesis within
target cell
• Fast expression (approx. 3–4 hrs
compared to 1–2 days) following VLP
introduction into target cells
• Obviates need to use expensive
antigen purification for proteins or
antigens produced inside target cells
Development Stage:
• Pilot
• Pre-clinical
• In vitro data available
• In vivo data available (animal)
Inventors: Stanislaw J. Kaczmarczyk
and Deb K. Chatterjee (NCI).
Intellectual Property: HHS Reference
No. E–264–2011/0—US Application No.
61/615,687 filed 26 Mar 2012.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
lauren.nguyen-antczak@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 Novel Delivery of
Packaged RNA to Mammalian Cells. For
collaboration opportunities, please
contact Kevin Brand at
brandk@mail.nih.gov.
mstockstill on DSK4VPTVN1PROD with
A Combinatorial Cloning Platform for
Construction of Expression Vectors for
Protein Production
Description of Technology: The
Combinatorial Cloning Platform (CCP)
of this invention is a collection of
vectors for use with the Gateway
Multisite Recombination System (Life
Technologies). The CCP that is currently
available includes plates of 192 glycerol
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stocks of E. coli each containing one of
the library plasmids, and a collection of
24 DNAs that are the downstream
vectors for expression in different hosts.
Uses of this CCP include construction of
protein expression constructs with
various fusion tags, generation of
expression constructs with different
promoters for in vivo expression, and
production of clones with fluorescent
tags for localization experiments. The
advantage of the CCP is based on the
exquisite specificity of the Multisite
Gateway reactions, which permit
linkage of multiple elements in a
directional fashion and involve no
additional DNA amplification. There is
also no need for restriction-based
cloning processes, which have a high
rate of failure and may require
optimization depending on the sites
available in a given clone. The CCP
library includes clones for fluorescent
and luminescent reporters, epitope and
solubility fusion tags, bimolecular
fluorescence complementation (BiFC)
fusions, 18 different eukaryotic
promoters, and many other useful
clones. In addition, the destination
vector collection contains two flavors of
Gateway destination vectors for E. coli,
baculovirus, mammalian, and lentiviral
expression.
Potential Commercial Applications:
• Construction of protein expression
constructs with various fusion tags
• Generation of expression constructs
with different promoters for in vivo
expression
• Production of clones with
fluorescent tags for localization
experiments
• Generation of constructs for making
mutant cell lines or transgenic animals
• Production of vectors for shRNA or
miRNA delivery
Competitive Advantages: The CCP is
considerably more flexible than
currently available commercial systems
for construction of protein expression
constructs.
Development Stage:
• Prototype
• Pre-clinical
• In vitro data available
Inventor: Dominic Esposito (NCI).
Publication: Hopkins RF, et al.
Optimizing transient recombinant
protein expression in mammalian cells.
Methods Mol Biol. 2012;801:251–68.
[PMID 21987258].
Intellectual Property: HHS Reference
No. E–164–2011/0—Research Tools.
Patent protection is not being pursued
for these technologies.
Licensing Contact: Suryanarayana
Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
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3439
Therapeutic Peptide Treatment for
Dyslipidemic and Vascular Disorders
Description of Technology: This
invention is directed to use of certain
peptide analogs comprising multiple
amphipathic helical domains that are
able to promote cellular lipid efflux and
stimulate lipoprotein lipase activity. As
a result, administration of invention
peptides lead to reduced incidences of
hypertriglyceridemia without inducing
toxicity. Existing peptides that stimulate
efflux of lipids from cells exhibit
unacceptably high toxicity. Invention
peptides are superior to existing
peptides and can also be used to treat
or prevent a vast range of vascular
diseases, and their dyslipidemic
precursors. Exemplary vascular diseases
and conditions that could benefit from
treatment with the invention peptides
include: dyslipidemia, hyperlipidemia,
hypercholesterolemia, HDL deficiency,
coronary heart disease, atherosclerosis,
and thrombic stroke.
Potential Commercial Applications:
• Treatment of dyslipidemic and
vascular disorders
• Method of identifying therapeutic
non-cytotoxic peptides
Competitive Advantages:
• Specific control of lipid efflux and
transport
• Transient hypertriglyceridemia
with no reported toxicity
Development Stage:
• Early-stage
• Pre-clinical
• In vitro data available
• In vivo data available (animal)
Inventors: Alan T Remaley and
Marcelo A Amar (NHLBI).
Publications:
1. Remaley AT, et al. Synthetic
amphipathic helical peptides promote
lipid efflux from cells by an ABCA1dependent and an ABCA1-independent
pathway. J Lipid Res. 2003
Apr;44(4):828–36. [PMID 12562845].
2. Sviridov DO, et al. Helix
stabilization of amphipathic peptides by
hydrocarbon stapling increases
cholesterol efflux by the ABCA1
transporter. Biochem Biophys Res
Commun. 2011 Jul 8;410(3):446–51.
[PMID 21672528].
3. Osei-Hwedieh DO, et al.
Apolipoprotein mimetic peptides:
Mechanisms of action as antiatherogenic agents. Pharmacol Ther.
2011 Apr;130(1):83–91. [PMID
21172387].
Intellectual Property: HHS Reference
No. E–138–2008/0—US Patent
Application No. 12/937,974 filed 14 Oct
2010.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
lauren.nguyen-antczak@nih.gov.
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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices
Dated: January 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–00738 Filed 1–15–13; 8:45 am]
BILLING CODE 4140–01–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:
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.
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.
mstockstill on DSK4VPTVN1PROD with
SUMMARY:
Transmission-Blocking Malaria
Vaccine
Description of Technology: There is
no vaccine for malaria, and there is
growing resistance to existing antimalarial drugs. Sexual stage-specific
antigens are of interest as vaccine
candidates because disruption of these
antigens would reduce the fertility and,
thus, the infectivity of the parasite.
This invention claims methods and
compositions for delivering a
Plasmodium P47 vaccine or antibody to
P47 to prevent Plasmodium falciparum
or Plasmodium vivax malaria. P47 and
other antigens have been mentioned as
potential transmission-blocking
vaccines due to their surface location on
gametes. The gene for P47 antigens is
also well characterized. Recent
discoveries have noted that P47 allows
the parasite to suppress or evade the
immune system, thereby ensuring the
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mosquitoes’ survival. Recent discoveries
have also shown the mechanism by
which P47 enables survival of the
parasite by manipulation of the
mosquito immune system. Based on the
critical role of P47 antigens in
transmission, the disruption of the
function of P47 by various means can be
an innovative and forceful means to
control and/or reduce the prevalence of
malaria.
Potential Commercial Applications:
Malaria vaccine, diagnostic and
therapeutic.
Competitive Advantages:
• Single protein malaria
transmission-blocking vaccine.
• Cost-effective, simple
manufacturing process for vaccine.
• Potentially lower-cost malarial
vaccine for developing/developed
countries.
Development Stage:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: Carolina Barillas-Mury and
Alvaro Molina-Cruz (NIAID).
Publication: Molina-Cruz A, et al.
Some strains of Plasmodium falciparum,
a human malaria parasite, evade the
complement-like system of Anopheles
gambiae mosquitoes. Proc Natl Acad Sci
U S A. 2012 Jul 10;109(28):E1957–62.
[PMID 22623529]
Intellectual Property: HHS Reference
No. E–222–2012/0 — US Application
No. 61/684,333 filed 17 Aug 2012.
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases (NIAID) is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize malaria vaccines,
diagnostics and therapeutics. For
collaboration opportunities, please
contact Tristan J. Mahyera at
tristan.mahyera@nih.gov or 301–827–
0251.
Methods and Composition for
Identification of Variants of JC Virus
DNA; An Etiologic Agent for
Progressive Multifocal
Leukoencephalopathy (PML)
Description of Technology: JC Virus
causes a fatal disease in the brain called
progressive multifocal
leukoencephalopathy (PML) that occurs
in many patients with
immunocompromised conditions. The
finding of JCV DNA in the patients with
neurological symptoms of PML is a
diagnostic criterion and is needed to
confirm the diagnosis of PML to rule out
other neurological conditions. Certain
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JC virus variants are known to have a
greater association with PML. For
example, ‘‘Prototype’’ JC virus is far
more pathogenic than ‘‘Archetype’’ JC
virus.
This invention claims novel assays for
identifying Archetype and/or Prototype
JC virus by detecting the presence or
absence of the unique Archetype
nucleic acid sequence in the non-coding
regulatory region of JC virus. While the
sequences of Archetype and Prototype
JC virus are known, these are the first
assays that allow discrimination
between Prototype and Archetype JC
virus in a simple assay without the need
for DNA sequencing. The identification
of a JC virus as a prototype can lead to
early treatment of infected individuals.
Potential Commercial Applications:
• JCV diagnostic kits.
• JCV diagnostics.
Competitive Advantages:
• DNA sequencing not required.
• Single assay format using same
template to identify prototype and
archetype with 10c/ml sensitivity.
Development Stage:
• Clinical.
• In vitro data available.
• In vivo data available (human).
Inventors: Eugene O. Major and
Caroline F. Ryschkewitsch (NINDS).
Publication: Perkins MR, et al.
Changes in JC Virus-Specific T Cell
Responses during Natalizumab
Treatment and in NatalizumabAssociated Progressive Multifocal
Leukoencephalopathy. PLoS Pathog.
2012 Nov;8(11):e1003014. [PMID
23144619]
Intellectual Property: HHS Reference
No. E–088–2012—US Application No.
61/661,289 filed 18 Jun 2012.
Related Technology: HHS Reference
No. E–152–2009/0—Research Material.
Patent protection is not being pursued
for this technology.
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Neurological
Disorders and Stroke is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize assays for the detection
of JC Virus. For collaboration
opportunities, please contact Melissa
Maderia at maderiam@mail.nih.gov or
301–451–3943.
Cross-Reactive Dengue Fully Human
Monoclonal Antibodies
Description of Technology: Among the
arthropod-borne flaviviruses, the four
dengue virus serotypes, dengue type 1
virus (DENV–1), dengue type 2 virus
(DENV–2), dengue type 3 virus (DENV–
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[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3437-3440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00738]
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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.
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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.
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.
Optical Microscope Software for Breast Cancer Diagnosis
Description of Technology: The instant invention discloses a
software to analyze optical microscopic images of human breast tissue
sections for diagnosing cancer by using the differences in spatial
positioning of certain genes. The software uses the inherent hierarchy
in the data and stores all the analysis and manual interaction
information in a highly structured XML file. It is a user-friendly
software to discriminate normal and cancerous human breast tissue
section images that can be used for large experiments. Additionally the
software uses a cluster of computers in the background to reduce the
analysis time for large image datasets. Furthermore, the software of
instant invention provides a set of tools for performing diagnostic or
prognostic assays on new unseen datasets.
Potential Commercial Applications:
The software could be an essential part of an integrated
diagnostic or prognostic assay for breast cancer detection.
The software could be a key tool for biomedical research
to test new markers and their applicability for diagnostic purposes.
The use of the software could provide important
information for understanding the underlying causes of gene
repositioning.
Competitive Advantages:
The software of instant invention can be used to analyze
relatively large datasets.
To reduce the processing time by at least 10 fold.
The software can be used in a broad range of quantitative
image analysis applications.
Development Stage:
Prototype
Clinical
In vitro data available (human)
Inventors: Kaustav Nandy (SAIC-Frederick, Inc), Stephen J. Lockett
(SAIC-Frederick, Inc), Prabhakar R. Gudla (SAIC-Frederick, Inc),
William Cukierski (NCI), Renee Qian (NCI), Karen J. Meaburn (NCI), Tom
Misteli (NCI).
Publications:
1. Gudla PR, et al. A high-throughput system for segmenting nuclei
using multiscale techniques. Cytometry A. 2008 May;73(5):451-66. [PMID
18338778]
2. Nandy K, et al. Automatic nuclei segmentation and spatial FISH
analysis for cancer detection. Conf Proc IEEE Eng Med Biol Soc.
2009;2009:6718-21. [PMID 19963931].
3. Meaburn KJ, et al. Disease-specific gene repositioning in breast
cancer. J Cell Biol. 2009 Dec 14;187(6):801-12. [PMID 19995938].
4. Cukierski WJ, et al. Ranked retrieval of segmented nuclei for
objective assessment of cancer gene repositioning. BMC Bioinformatics.
2012 Sep 12;13:232. [PMID: 22971117].
5. Nandy K, et al. Supervised learning framework for screening
nuclei in tissue
[[Page 3438]]
sections. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:5989-92. [PMID
22255704]
Intellectual Property: HHS Reference No. E-286-2012/0--Software.
Patent protection is not being pursued for this technology.
Licensing Contact: Susan Ano, Ph.D.; 301-435-5515;
anos@mail.nih.gov.
Collaborative Research Opportunity: The SAIC-Frederick Optical
Microscopy and Analysis Laboratory is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate or commercialize this technology. For
collaboration opportunities, please contact John Hewes, Ph.D., at
hewesj@mail.nih.gov.
Simple Direct Zirconium-89 Cell PET Label, \89\Zr-Labeled Cells, and
Methods for Real-Time In Vivo Pet Imaging
Description of Technology: The capability to image cells and
cellular processes in real time over a scale of days could dramatically
improve research insights and the effectiveness of cell-based
therapies. Zirconium-89 (\89\Zr) has a half-life of over three days
(78.4 hours) over 44 times longer compared to Fluorine (\18\F) the most
commonly used PET isotope (half-life of 1 hour and 50 minutes). \89\Zr
is also advantageous compared to other long half-life isotopes because
it is not limited by high background activity and cell toxicity.
Labeling cells with \89\Zr, is currently accomplished by indirect
methods using secondary cell-type specific reagents such as antibodies.
This technology is a PET imaging complex of \89\Zr and polycation that
is internalized by the cells. This complex has been able to directly
label a wide range of cells, without the use of secondary reagents.
\89\Zr-labeled cells of lymphocytic lineage, including T cells, natural
killer T-cells, macrophages, dendritic cells, and stem cells, have been
produced and imaged in vivo with minimal damage to the cells. This PET
imaging agent can be readily combined with an MR imaging agent for
combined PET/MR imaging of cells. The imaging capabilities enabled by
this technology may significantly improve cell therapies, cell level
diagnostics and aid research for non-cell based therapies.
Potential Commercial Applications:
Imaging
Diagnostic
Cell therapies
Transplantation and transfusion
Competitive Advantages:
Direct labeled cells (versus indirect techniques)
Longer half-life
Not limited by high background activity and cell toxicity
Development Stage:
Early-stage
Pre-clinical
In vivo data available (animal)
Inventors: Omer Aras (CC), Peter Choyke (NCI), Joseph Frank (CC),
Noriko Sato (CC), Jeremy Pantin (NHLBI).
Intellectual Property: HHS Reference No. E-056-2012/0--US
Provisional Application No. 61/611964 filed 16 Mar 2012.
Licensing Contact: Tedd Fenn; 301-435-5031; Tedd.Fenn@nih.gov
Collaborative Research Opportunity: The NCI is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize this technology.
For collaboration opportunities, please contact John Hewes, Ph.D., at
hewesj@mail.nih.gov.
Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules
Engineered Therapies
Description of Technology: This technology relates to small (~27
kDa) antibody fragments that are potentially useful for therapeutic
development. These are monomeric IgG fragment crystalizable (mFc)
compositions; they are long half-lived, functional (pH dependent
binders of neonatal Fc receptor--FcRn); and they are soluble and
express efficiently in E. coli. These molecules may serve as a platform
for development of engineered mFc-based antibodies and fusion proteins
with therapeutic applications. Efforts to engineer antibody-based
therapeutics, to date, have encountered technical limitations due to
the relatively large fragment size and short fragment half-life. The
IgG fragment crystalizable (Fc) is a dimer of two constant domains
(CH2-CH3 chains). Fc has a long half-life, which makes it promising as
a candidate for engineering antibody therapeutics. Fusion proteins
based on Fc dimer molecules demonstrate extended half-life, due to the
ability to bind FcRn at acidic pH. However, the relatively large size
of the Fc domains (~50 kD) is not optimal. This technology uses smaller
(~27 kDa) mFc compositions that retain efficient binding to human FcRn
and demonstrate long half-life. These mFc compositions are promising
for the development of novel therapeutics because the smaller size may
allow for superior access to targets and tissues compared to full sized
mAbs and larger fragment-based therapeutics, while also retaining
important function characteristics.
Potential Commercial Applications: Therapeutics--human and
veterinary, engineered antibody and fusion proteins.
Competitive Advantages: Smaller size results better tissue
penetration, reduced steric hindrance, increased therapeutic efficiency
and lower cost.
Development Stage:
Early-stage
Pre-clinical
Inventors: Dimiter S. Dimitrov and Tianlei Ying (NCI).
Publication: Ying T, et al. Soluble monomeric IgG1 Fc. J Biol Chem.
2012 Jun 1; 287(23):19399-408. [PMID 22518843].
Intellectual Property: HHS Reference No. E-019-2012/0--U.S. Patent
Application No. 61/612,138 filed 16 Mar 2012.
Related Technologies: HHS Reference No. E-003-2007/0--
U.S. Patent Application No. 61/063,245 filed 31 Jan 2008
PCT Application No. PCT/US2009/0326 and related
international applications filed on 30 Jan 2009 in Australia, Canada,
China, Europe, Japan, and India
U.S. Patent Application No. 12/864,758 filed 27 Jul 2010
Licensing Contact: Tedd Fenn; 301-435-5031; Tedd.Fenn@nih.gov
Collaborative Research Opportunity: The NCI/CCR/NP is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules
Engineered Therapies. For collaboration opportunities, please contact
John Hewes, Ph.D., at hewesj@mail.nih.gov">#hewesj@mail.nih.gov.
Virus-Like Particles Mediated Protein and RNA Delivery
Description of Technology: The invention is directed to novel
virus-like particles (VLPs) that are capable of binding to and
replicating within a target mammalian cell, including human cells. The
claimed VLPs are safer than viral delivery because they are incapable
of re-infecting target cells. The present VLPs can optionally comprise
inhibitory recombinant polynucleotides, such as microRNA, antisense RNA
or small hairpin RNA, to down regulate or turn off expression of a
particular gene within the target cell. Alternatively, recombinant
polynucleotides packaged within VLPs can comprise a gene encoding a
therapeutic protein so as to enable expression of that protein within
the
[[Page 3439]]
target cell. Specifically, VLPs of the invention are composed of an
alphavirus replicon that contains a recombinant polynucleotide, a
retroviral gag protein, and a fusogenic envelope glycoprotein.
While the claimed VLPs have a variety of applications, therapeutic
uses of the VLPs include directing antibody synthesis and converting
cancer cells into antigen presenting cells. Additional applications
include using VLPs to induce fast (approx. 3-4 hrs) and high levels of
protein production in mammalian cells.
Potential Commercial Applications:
Delivery of microRNA and small hairpin RNA to reduce
express of targeted genes in a human cell
Delivery of coding RNA for robust expression in mammalian
systems
Direct antibody production by in vivo injection of
replicons (no antigen purification)
Therapeutic applications
Competitive Advantages:
High level (~million copies per cell) of RNA production/
synthesis within target cell
Fast expression (approx. 3-4 hrs compared to 1-2 days)
following VLP introduction into target cells
Obviates need to use expensive antigen purification for
proteins or antigens produced inside target cells
Development Stage:
Pilot
Pre-clinical
In vitro data available
In vivo data available (animal)
Inventors: Stanislaw J. Kaczmarczyk and Deb K. Chatterjee (NCI).
Intellectual Property: HHS Reference No. E-264-2011/0--US
Application No. 61/615,687 filed 26 Mar 2012.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; lauren.nguyen-antczak@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
Novel Delivery of Packaged RNA to Mammalian Cells. For collaboration
opportunities, please contact Kevin Brand at brandk@mail.nih.gov.
A Combinatorial Cloning Platform for Construction of Expression Vectors
for Protein Production
Description of Technology: The Combinatorial Cloning Platform (CCP)
of this invention is a collection of vectors for use with the Gateway
Multisite Recombination System (Life Technologies). The CCP that is
currently available includes plates of 192 glycerol stocks of E. coli
each containing one of the library plasmids, and a collection of 24
DNAs that are the downstream vectors for expression in different hosts.
Uses of this CCP include construction of protein expression constructs
with various fusion tags, generation of expression constructs with
different promoters for in vivo expression, and production of clones
with fluorescent tags for localization experiments. The advantage of
the CCP is based on the exquisite specificity of the Multisite Gateway
reactions, which permit linkage of multiple elements in a directional
fashion and involve no additional DNA amplification. There is also no
need for restriction-based cloning processes, which have a high rate of
failure and may require optimization depending on the sites available
in a given clone. The CCP library includes clones for fluorescent and
luminescent reporters, epitope and solubility fusion tags, bimolecular
fluorescence complementation (BiFC) fusions, 18 different eukaryotic
promoters, and many other useful clones. In addition, the destination
vector collection contains two flavors of Gateway destination vectors
for E. coli, baculovirus, mammalian, and lentiviral expression.
Potential Commercial Applications:
Construction of protein expression constructs with various
fusion tags
Generation of expression constructs with different
promoters for in vivo expression
Production of clones with fluorescent tags for
localization experiments
Generation of constructs for making mutant cell lines or
transgenic animals
Production of vectors for shRNA or miRNA delivery
Competitive Advantages: The CCP is considerably more flexible than
currently available commercial systems for construction of protein
expression constructs.
Development Stage:
Prototype
Pre-clinical
In vitro data available
Inventor: Dominic Esposito (NCI).
Publication: Hopkins RF, et al. Optimizing transient recombinant
protein expression in mammalian cells. Methods Mol Biol. 2012;801:251-
68. [PMID 21987258].
Intellectual Property: HHS Reference No. E-164-2011/0--Research
Tools. Patent protection is not being pursued for these technologies.
Licensing Contact: Suryanarayana Vepa, Ph.D., J.D.; 301-435-5020;
vepas@mail.nih.gov.
Therapeutic Peptide Treatment for Dyslipidemic and Vascular Disorders
Description of Technology: This invention is directed to use of
certain peptide analogs comprising multiple amphipathic helical domains
that are able to promote cellular lipid efflux and stimulate
lipoprotein lipase activity. As a result, administration of invention
peptides lead to reduced incidences of hypertriglyceridemia without
inducing toxicity. Existing peptides that stimulate efflux of lipids
from cells exhibit unacceptably high toxicity. Invention peptides are
superior to existing peptides and can also be used to treat or prevent
a vast range of vascular diseases, and their dyslipidemic precursors.
Exemplary vascular diseases and conditions that could benefit from
treatment with the invention peptides include: dyslipidemia,
hyperlipidemia, hypercholesterolemia, HDL deficiency, coronary heart
disease, atherosclerosis, and thrombic stroke.
Potential Commercial Applications:
Treatment of dyslipidemic and vascular disorders
Method of identifying therapeutic non-cytotoxic peptides
Competitive Advantages:
Specific control of lipid efflux and transport
Transient hypertriglyceridemia with no reported toxicity
Development Stage:
Early-stage
Pre-clinical
In vitro data available
In vivo data available (animal)
Inventors: Alan T Remaley and Marcelo A Amar (NHLBI).
Publications:
1. Remaley AT, et al. Synthetic amphipathic helical peptides
promote lipid efflux from cells by an ABCA1-dependent and an ABCA1-
independent pathway. J Lipid Res. 2003 Apr;44(4):828-36. [PMID
12562845].
2. Sviridov DO, et al. Helix stabilization of amphipathic peptides
by hydrocarbon stapling increases cholesterol efflux by the ABCA1
transporter. Biochem Biophys Res Commun. 2011 Jul 8;410(3):446-51.
[PMID 21672528].
3. Osei-Hwedieh DO, et al. Apolipoprotein mimetic peptides:
Mechanisms of action as anti-atherogenic agents. Pharmacol Ther. 2011
Apr;130(1):83-91. [PMID 21172387].
Intellectual Property: HHS Reference No. E-138-2008/0--US Patent
Application No. 12/937,974 filed 14 Oct 2010.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; lauren.nguyen-antczak@nih.gov.
[[Page 3440]]
Dated: January 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-00738 Filed 1-15-13; 8:45 am]
BILLING CODE 4140-01-P
