Government-Owned Inventions; Availability for Licensing, 29763-29766 [2010-12794]
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Federal Register / Vol. 75, No. 102 / Thursday, May 27, 2010 / Notices
visit our Web site at https://healthit.hhs.gov
for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (Pub. L. 92–
463, 5 U.S.C., App. 2).
Dated: May 17, 2010.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2010–12715 Filed 5–26–10; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Assessing the Long-Term
Impacts of the John E. Fogarty
International Center’s Research and
Training Programs
ACTION:
Notice.
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
John E. Fogarty International Center, the
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Assessing the Long-Term
Impacts of the John E. Fogarty
International Center’s Research and
Training Programs.
Type of Information Collection
Request: New collection.
Need and Use of Information
Collection: This study will inform
investment decisions and strategies
employed by the Fogarty International
Center for the purpose of strengthening
biomedical research capacity in low and
middle income countries. The primary
objective of the study is to develop
detailed case studies of the long-term
impacts of Fogarty’s research and
training programs on educational
institutions located in low and middle
income countries. The findings will
provide valuable information
concerning return on the Center’s
investments over the past twenty years
and effective strategies for promoting
research capacity development in the
future.
Frequency of Response: Once.
Affected Public: Individuals.
Type of Respondents: Current and
former NIH grantees; Current and former
NIH trainees in countries of interest;
Leaders and administrators at
institutions of interest; Policy-makers
and scientific leaders in countries of
interest.
Estimated Number of Respondents:
105 per institution; total of 10
institutions over five years.
Estimated Number of Responses per
Respondent: 1.
Average Burden Hours per Response:
1 hour for interview participants; 2
hours for focus group participants.
Estimated Total Annual Burden
Hours Requested: 290 and the
annualized cost to respondents is
estimated at $4,841.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Number of
institutions per
year
Number of
responses per
respondent
Interviews with U.S.-based principal investigators ..............
Focus groups with selected trainees and follow-on survey
Interviews with university leadership ...................................
Interviews with trainees .......................................................
Interviews with foreign grantees ..........................................
Interviews with foreign policy-makers/scientific leaders ......
20
40
4
13
20
8
2
2
2
2
2
2
1
1
1
1
1
1
1
2
1
1
1
1
40
160
8
26
40
16
Total ..............................................................................
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Number of
respondents/
participants
per institution
105
........................
........................
........................
290
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.
ADDRESSES: You may submit comments
via regular mail to Dr. Linda Kupfer,
VerDate Mar<15>2010
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Average
burden hours
per response
Estimated total
annual burden
hours
requested
Fogarty International Center, National
Institutes of Health, 16 Center Drive,
MSC 6705, Building 16, Room 202,
Bethesda, MD 20892 or via electronic
mail to kupferl@mail.nih.gov.
Dated: May 19, 2010.
Timothy J. Tosten,
Executive Officer, Office of Administrative
Management and International Services, John
E. Fogarty International Center, National
Institutes of Health.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Linda Kupfer,
Fogarty International Center, National
Institutes of Health, 16 Center Drive,
Building 16, Room 202, Bethesda, MD
20892, or call 301–496–1491 (this is not
a toll-free number), or E-mail your
request, including your address to:
kupferl@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.
[FR Doc. 2010–12782 Filed 5–26–10; 8:45 am]
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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
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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.
Simple, Quantitative and Highly
Specific Antibody Detection of Lyme
Disease
Description of Invention: This
invention uses the Luciferase
Immunoprecipitation System (LIPS) as a
highly specific and high throughput
method for diagnosing Borrelia
burgdorferi (Bb) infection, a causative
agent of Lyme disease. Many antigens,
fused to the renilla luciferase (RUC)
system, were tested for their ability to
detect the disease; however, a novel
synthetic protein called VOVO
displayed the highest sensitivity and
specificity of those tested. VOVO
demonstrated 94% sensitivity and 100%
specificity and markedly out-performed
the C6 ELISA test (currently the most
sensitive test available, with 76%
sensitivity and 98% specificity) in an
analysis of independent validation
serum sets. Unlike the C6 ELISA, the
VOVO LIPS assay displayed a wide
dynamic range of antibody detection
spanning over a 10,000-fold range
without serum dilution. These results
indicate that LIPS screening method
using VOVO or other Bb antigens offer
a more convenient, efficient and
quantitative approach to serological
screening of antibodies to Lyme disease.
The VOVO LIPS test may benefit from
a large market as it could potentially
become part of a routine screening panel
for Lyme disease. In addition to its high
sensitivity and specificity, the test also
provides a rapid, simple and highthrough-put approach for efficient
screening of the disease. It may also be
adapted for detection of Borrelia species
endemic to other regions of the world.
Applications:
• Increased sensitivity and specificity
for detection of Lyme disease.
• Rapid and convenient detection of
Lyme disease.
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Development Status: Early Stage.
Market: 29,000 new cases per year in
the U.S.
Inventors: Peter D. Burbelo (NIDCR),
Michael J. Iadarola (NIDCR), Adriana R.
Marques (NIAID).
Publication: PD Burbelo et al. Rapid,
Simple, Quantitative, and Highly
Sensitive Antibody Detection for Lyme
Disease. Clin Vaccine Immunol. 2010
Apr 14; Epub ahead of print,
doi:10.1128/CVI.00476–09. [PubMed:
20392886]
Patent Status: U.S. Provisional
Application No. 61/312,520 filed 10 Mar
2010 (HHS Reference No. E–036–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Susan Ano, PhD;
301–435–5515; anos@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Dental and
Craniofacial Research, Laboratory of
Sensory Biology, Neurobiology and Pain
Therapeutics Section, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact David W. Bradley, PhD at 301–
402–0540 or bradleyda@nidcr.nih.gov.
Software System for Processing and
Analysis of Multi-Dimensional NMR
Data
Description of Invention: Available for
licensing is a software system useful in
applications involving nuclear magnetic
resonance (NMR). The software system,
called NMRPipe, is written in the C
programming language, and makes use
of the TCL/TK scripting environment.
The system includes over 500 modules
for processing and analyzing
experimental data of one to four
dimensions collected on NMR
spectrometers. The system exploits the
UNIX computer operating system
facilities of pipelines and scripts to link
modules in a highly flexible, userdefinable manner. NMR is a widely
used analytical method, applied to both
solution and solid state samples. The
information obtained from such data
pertains to the structure, motion, and
interactions of molecular systems,
including proteins, nucleic acids, and
organic molecules.
Applications:
• Biomedical research for studying
protein and nucleic acid structures and
their interactions.
• Chemical applications involving
synthesis, identification, or production
of organic molecules.
Development Status:
• The software is mature.
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• Binary executables of the software
have been widely distributed, both to
academic institutions as well as
commercial organizations.
• The software is under active
development.
• The software will be readily
available upon request.
Inventors: Frank Delaglio (NIDDK).
Related Publications:
1. Kontaxis G, Delaglio F, Bax A.
Molecular fragment replacement
approach to protein structure
determination by chemical shift and
dipolar homology database mining.
Methods Enzymol. 2005;394:42–78.
[PubMed: 15808217]
2. Delaglio F, Wu Z, Bax A.
Measurement of homonuclear proton
couplings from regular 2D COSY
spectra. J Magn Reson. 2001
Apr;149(2):276–281. [PubMed:
11318630]
3. Cornilescu G, Delaglio F, Bax A.
Protein backbone angle restraints from
searching a database for chemical shift
and sequence homology. J Biomol NMR.
1999 Mar;13(3):289–302. [PubMed:
10212987]
4. Delaglio F, Grzesiek S, Vuister GW,
Zhu G, Pfeifer J, Bax A. NMRPipe: a
multidimensional spectral processing
system based on UNIX pipes. J Biomol
NMR. 1995 Nov;6(3):277–293. [PubMed:
8520220]
Patent Status: HHS Reference No. E–
076–2009/0—Software. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing.
Licensing Contacts: Uri Reichman,
PhD, MBA; 301–435–4616;
UR7a@nih.gov; or John Stansberry, PhD;
301–435–5236; js852e@nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize the
NMRPipe software system. Please
contact Cindy Fuchs at 301–451–3636
or Frank Delaglio at
frankde@niddk.nih.gov for more
information.
Target Activated Microdissection—Kits
and High Throughput Applications
Description of Invention: A variety of
techniques have been used to
microdissect specific cells or cell
populations from a histological sample
under direct microscopic visualization.
Original microdissection techniques
involved painstaking (and sometimes
clumsy) manual dissection using
needles or other micro-manipulation
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devices to isolate individual cells based
on visible, histological characteristics.
The subject technology is a novel
method of performing specific target
activated transfer from a biological
sample (i.e. tissue) for analysis using a
device system that can be automated for
high throughput analysis or using
benchtop kits. The method employs a
localized reagent, such as an absorbative
stain or immunoreagent that specifically
determines the microadhesion of
desired cellular material in a tissue
sample to a transfer surface such as a
thermoplastic polymer film. The energy
from a light or heat source causes the
specific microadhesion of the target
cells or cell populations to the
thermoplastic transfer surface without
damage to the cells. Subsequent
separation of the film from the tissue
section selectively removes the adhered
target from the tissue section. The
method is specific and eliminates the
need for direct manual visualization.
Kits based on the method have the
distinct advantage of not requiring
expensive equipment; and thus, are a
cost effective option for microdissection
and analysis.
Applications:
• Microdissection and analysis kits
for histological samples.
• High throughput analysis of
biological samples.
Advantages:
• Does not require a visual detection
step.
• Kits based on the method are low
cost options for microdissection.
• Automated high throughput
microdissection and analysis
capabilities.
Development Status: In vitro data can
be provided upon request.
Inventors: Michael R. Emmert-Buck
(NCI), Robert F. Bonner (NICHD), et al.
Publications:
1. Tangrea MA, Chuaqui RF, Gillespie
JW, Ahram M, Gannot G, Wallis BS,
Best CJ, Linehan WM, Liotta LA, Bonner
RF, Emmert-Buck MR. Expression
microdissection: operator-independent
retrieval of cells for molecular profiling.
Diagn Mol Pathol. 2004 Dec;13(4):207–
212. [PubMed: 15538110]
2. Grover A, Woodson KA, Tangrea
MA, Wallis BS, Hanson J, Chuaqui RF,
Gillespie JW, Erickson HS, Bonner RF,
Pohida T, Emmert-Buck MR, Libutti SK.
Tumor-associated endothelial cells
display GSTP1 and RAR beta2 promoter
methylation in human prostate cancer. J
Translational Med. 2006 Mar 2;4:13.
[PubMed: 16512911]
3. Hanson JC, Rodriguez-Canales J,
Bonner RF, Pohida T, Tangrea MT,
Emmert-Buck MR. Expression
Microdissection Adapted to Commercial
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Laser Dissection Instruments (Submitted
for publication).
Patent Status:
HHS Reference No. E–113–2003/0—
• U.S. Patent Application No. 10/
543,218 filed 22 Jul 2005, allowed.
• U.S. Patent Application No. 12/
753,566 filed 02 Apr 2010.
• Australian Patent 2003256803
issued 21 Jan 2010.
• Australian Patent Application No.
2009250964 filed 23 Jul 2009.
• Canadian Patent Application No.
2513646 filed 23 Jun 2003.
HHS Reference No. E–113–2003/1—
• U.S. Patent 7,695,752 issued 13 Apr
2010.
• U.S. Patent Application No. 12/
713,105 filed 24 Feb 2010.
Licensing Status: Available for
licensing.
Licensing Contact: Kevin W. Chang,
PhD; 301–435–5018;
changke@mail.nih.gov.
• U.S. Patent Application No. 11/
571,879 filed 09 Jan 2007, claiming
priority to 09 Jul 2004 (HHS Reference
No. E–249–2004/1–US–02).
• U.S. Patent Application No. 12/
426,901 filed 20 Apr 2009, claiming
priority to 01 Nov 2000 (HHS Reference
No. E–308–2000/0–PCT–02); and related
international patent/patent applications.
Licensing Status: Available for
licensing.
Licensing Contact: Kevin W. Chang,
PhD; 301–435–5018;
changke@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 HIV DNA vaccines.
Please contact John D. Hewes, PhD at
301–435–3121 or hewesj@mail.nih.gov
for more information.
Therapeutic HIV Vaccine and
Associated Protocols
Description of Invention: This
technology describes a therapeutic HIV
DNA vaccine to be administered to
individuals who have previously
experienced or are undergoing
antiretroviral therapy (ART). The
therapeutic DNA vaccine can also be
administered in combination with a
vector encoding an IL–15 and/or IL–15
receptor alpha (IL–15Ra) polypeptide. In
primate studies, the technology was
found to be particularly effective when
the vaccine composition was
administered by electroporation and
expressed six (6) HIV antigens
(including two (2) gag polypeptides and
two (2) envelope polypeptides) and IL–
15 and IL–15Ra. The antigens are
typically modified with a destabilizing
sequence, a secretory polypeptide and/
or a degradation signal. Successive
administration up to as many as nine
resulted in continual boost of the
immune response against the encoded
antigen. A potent immunotherapeutic
vaccine as described here could be an
important technology for the fight
against HIV/AIDS.
Applications: Therapeutic HIV DNA
vaccines.
Development Status: Primate data
available.
Inventors: Barbara Felber et al. (NCI).
Patent Status:
• U.S. Patent Application No. 12/
522,775 filed 10 Jul 2009, claiming
priority to 12 Jan 2007 (HHS Reference
No. E–103–2007/0–US–03).
• U.S. Patent Application No. 12/
160,263 filed 08 Jul 2008, claiming
priority to 13 Jan 2006 (HHS Reference
No. E–254–2005/2–US–12); and related
international patent applications.
A Novel Chimeric Bifunctional Protein
for Prevention and Treatment of HIV
Infection
Description of Invention: This
invention relates to bifunctional fusion
proteins effective in HIV neutralization.
Specifically, the invention is a
genetically engineered chimeric protein
composed of a soluble extracellular
region of human CD4 (sCD4) attached
via a flexible polypeptide linker to a
single-chain construct of a human
monoclonal antibody directed against a
CD4-induced, highly conserved gp120
determinant involved in co-receptor
interaction and virus entry.
Mechanistically, the binding of the
sCD4 moiety to the HIV gp120 Env
glycoprotein induces a conformational
change that enables the antibody moiety
to bind, thereby blocking Env function
and virus entry. This novel design
provides the protein with unique
characteristics that enables its extremely
strong binding to gp120, thus rendering
it a potential effective antiviral agent
against HIV. Recent studies (Lagenaur et
al. Retrovirology 7:11, 2010) indicate
that this novel bispecific protein
displays extremely broad neutralizing
activity against genetically diverse
primary HIV–1 isolates, with breadth
much greater than previously described
(Dey et al. J. Virology 77:2859, 2003).
The potency is generally at least 10-fold
greater than the best described HIV–1
neutralizing monoclonal antibodies, and
the protein is highly active against many
HIV–1 isolates that are refractory to
neutralization by these antibodies. The
bifunctional protein is comparably
potent against isogenic virions produced
from a human cell line versus PBMC; by
contrast, the broadly-reactive
monoclonal antibodies are much less
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potent against virions produced from
PBMC, perhaps due to differences in
glycosylation. Importantly, the
bifunctional protein is composed of
almost entirely human sequences. It
potentially can be linked to other
functional moieties to achieve desired
properties (longer plasma half-life,
selective killing of HIV-infected cells,
imaging of viral reservoirs, etc.).
The chimeric protein of this invention
has considerable potential for
prevention of HIV–1 infection, both as
a topical microbicide and as a systemic
agent to protect during and after acute
exposure (e.g. vertical transmission,
post exposure prophylaxis). It also has
potential utility for treatment of chronic
infection, including gene therapy
strategies involving hematopoietic stem
cells and/or viral vectors. Such proteins,
nucleic acid molecules encoding them,
and their production and use in
preventing or treating viral infections
are claimed in the patents issued for this
invention.
Applications:
• Prophylactic and/or therapeutic
treatment for HIV infection.
• Topical microbicide treatment to
protect against HIV infection.
• Imaging of HIV infected cells in
tissues.
Advantages:
• High neutralization efficiency due
to unique bifunctional binding
characteristics.
• Potentially minimally immunogenic
or toxic (human sequences and possibly
low treatment doses).
• Broad neutralizing activity.
• Mechanism of action less
susceptible to resistance.
Development Status:
• Reproducible production and scaleup of chimeric protein has been
demonstrated.
• Potent and broad neutralization of
genetically diverse HIV–1 clinical
isolates was demonstrated.
Market: The race to develop effective
antiviral strategies against HIV infection
is ongoing. The problems exhibited by
conventional drugs such (i.e. toxicity
and resistance) have triggered the
pursuit of alternative approaches to
HIV/AIDS prevention and treatment.
One of the new approaches is the
development of neutralizing antibodies
against the HIV envelope proteins. This
approach has not yet yielded any
commercially viable treatment. It is
believed that the approach presented in
the subject invention will circumvent
many of the shortcomings of the existing
drugs and other pursued approaches. If
this approach is successful the
commercial rewards will be huge
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because of the global magnitude of HIV
epidemics.
Inventor: Edward A. Berger (NIAID).
Related Publications:
1. Lagenaur LA, Villarroel VA,
Bundoc V, Dey B, Berger EA. sCD4–17b
bifunctional protein: Extremely broad
and potent neutralization of HIV–1
pseudotyped viruses from genetically
diverse primary isolates. Retrovirology
2010 Feb 16; 7:11. [PubMed: 20158904]
2. Dey B, Del Castillo CS, Berger EA.
Neutralization of human
immunodeficiency virus type 1 by
sCD4–17b, a single-chain chimeric
protein, based on sequential interaction
of gp120 with CD4 and coreceptor. J
Virol. 2003 March; 77(5):2859–2865.
[PubMed: 12584309]
Patent Status:
HHS Reference No. E–039–1999/0—
• U.S. Patent No. 7,115,262, issued 03
Oct 2006.
• U.S. Application No. 11/535,957,
filed 27 Sep 2006, published 18 Oct
2007 as 20070243208.
• Australian Patent No. 765218,
issued 30 Jul 2003.
• European Patent No. 1161445
issued 03 Sep 2008 for France,
Germany, Great Britain, Italy.
• Applications pending in Canada,
Japan.
Licensing Status: Available for
licensing.
Licensing Contacts: Uri Reichman,
PhD, MBA; 301–435–4616;
ur7a@nih.gov; or Susan Ano, PhD, 301–
435–5515; anos@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID, Office of Technology
Development, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize ‘‘A Novel Chimeric
Protein for Prevention and Treatment of
HIV Infection.’’ Please contact
Marguerite J. Miller at 301–435–8619 for
more information.
Dated: May 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–12794 Filed 5–26–10; 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.
PO 00000
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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.
UOK 257, the First BHD Tumor Cell
Line, and UOK257–2 Wild Type FLCNRestored Renal Cell Line as In Vitro
and In Vivo Models of Energy/Nutrient
Sensing Through the AMPK and mTOR
Signaling Pathways
Description of Invention: Scientists at
the National Institutes of Health (NIH)
have developed a novel renal cell
carcinoma (RCC) cell line designated
UOK257, which was derived from the
surgical kidney tissue of a patient with
hereditary Birt-Hogg-Dube’ (BHD)
syndrome and companion cell line
UOK257–2 in which FLCN expression
has been restored by lentivirus
infection. These cell lines harbors a
germline mutation of FLCN gene (alias
BHD) and displays loss of
heterozygosity, can grow as xenograft in
nude mice. Patients affected with BHD
develop skin papules
(fibrofolliculomas), lung cysts,
spontaneous pneumothorax and an
increased risk for bilateral multifocal
renal tumors. Loss of both copies of the
FLCN gene has been documented in
BHD renal tumors; however, the
molecular mechanisms by which
inactivation of the encoded protein,
folliculin, leads to the BHD phenotype
are currently unknown. They have
developed an important research tool
for in vitro folliculin functional studies.
The companion cell line will be
extremely useful for comparative
biochemical analyses of cell culture
systems in which the FLCN gene is
either expressed or inactivated,
including identification of renal tumor
biomarkers, alteration of biochemical
pathways resulting from loss of FLCN
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]]>Agencies
[Federal Register Volume 75, Number 102 (Thursday, May 27, 2010)]
[Notices]
[Pages 29763-29766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12794]
-----------------------------------------------------------------------
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
[[Page 29764]]
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.
Simple, Quantitative and Highly Specific Antibody Detection of Lyme
Disease
Description of Invention: This invention uses the Luciferase
Immunoprecipitation System (LIPS) as a highly specific and high
throughput method for diagnosing Borrelia burgdorferi (Bb) infection, a
causative agent of Lyme disease. Many antigens, fused to the renilla
luciferase (RUC) system, were tested for their ability to detect the
disease; however, a novel synthetic protein called VOVO displayed the
highest sensitivity and specificity of those tested. VOVO demonstrated
94% sensitivity and 100% specificity and markedly out-performed the C6
ELISA test (currently the most sensitive test available, with 76%
sensitivity and 98% specificity) in an analysis of independent
validation serum sets. Unlike the C6 ELISA, the VOVO LIPS assay
displayed a wide dynamic range of antibody detection spanning over a
10,000-fold range without serum dilution. These results indicate that
LIPS screening method using VOVO or other Bb antigens offer a more
convenient, efficient and quantitative approach to serological
screening of antibodies to Lyme disease.
The VOVO LIPS test may benefit from a large market as it could
potentially become part of a routine screening panel for Lyme disease.
In addition to its high sensitivity and specificity, the test also
provides a rapid, simple and high-through-put approach for efficient
screening of the disease. It may also be adapted for detection of
Borrelia species endemic to other regions of the world.
Applications:
Increased sensitivity and specificity for detection of
Lyme disease.
Rapid and convenient detection of Lyme disease.
Development Status: Early Stage.
Market: 29,000 new cases per year in the U.S.
Inventors: Peter D. Burbelo (NIDCR), Michael J. Iadarola (NIDCR),
Adriana R. Marques (NIAID).
Publication: PD Burbelo et al. Rapid, Simple, Quantitative, and
Highly Sensitive Antibody Detection for Lyme Disease. Clin Vaccine
Immunol. 2010 Apr 14; Epub ahead of print, doi:10.1128/CVI.00476-09.
[PubMed: 20392886]
Patent Status: U.S. Provisional Application No. 61/312,520 filed 10
Mar 2010 (HHS Reference No. E-036-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Susan Ano, PhD; 301-435-5515; anos@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Dental and Craniofacial Research, Laboratory of Sensory Biology,
Neurobiology and Pain Therapeutics Section, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact David W. Bradley, PhD at 301-402-0540 or
bradleyda@nidcr.nih.gov.
Software System for Processing and Analysis of Multi-Dimensional NMR
Data
Description of Invention: Available for licensing is a software
system useful in applications involving nuclear magnetic resonance
(NMR). The software system, called NMRPipe, is written in the C
programming language, and makes use of the TCL/TK scripting
environment. The system includes over 500 modules for processing and
analyzing experimental data of one to four dimensions collected on NMR
spectrometers. The system exploits the UNIX computer operating system
facilities of pipelines and scripts to link modules in a highly
flexible, user-definable manner. NMR is a widely used analytical
method, applied to both solution and solid state samples. The
information obtained from such data pertains to the structure, motion,
and interactions of molecular systems, including proteins, nucleic
acids, and organic molecules.
Applications:
Biomedical research for studying protein and nucleic acid
structures and their interactions.
Chemical applications involving synthesis, identification,
or production of organic molecules.
Development Status:
The software is mature.
Binary executables of the software have been widely
distributed, both to academic institutions as well as commercial
organizations.
The software is under active development.
The software will be readily available upon request.
Inventors: Frank Delaglio (NIDDK).
Related Publications:
1. Kontaxis G, Delaglio F, Bax A. Molecular fragment replacement
approach to protein structure determination by chemical shift and
dipolar homology database mining. Methods Enzymol. 2005;394:42-78.
[PubMed: 15808217]
2. Delaglio F, Wu Z, Bax A. Measurement of homonuclear proton
couplings from regular 2D COSY spectra. J Magn Reson. 2001
Apr;149(2):276-281. [PubMed: 11318630]
3. Cornilescu G, Delaglio F, Bax A. Protein backbone angle
restraints from searching a database for chemical shift and sequence
homology. J Biomol NMR. 1999 Mar;13(3):289-302. [PubMed: 10212987]
4. Delaglio F, Grzesiek S, Vuister GW, Zhu G, Pfeifer J, Bax A.
NMRPipe: a multidimensional spectral processing system based on UNIX
pipes. J Biomol NMR. 1995 Nov;6(3):277-293. [PubMed: 8520220]
Patent Status: HHS Reference No. E-076-2009/0--Software. Patent
protection is not being pursued for this technology.
Licensing Status: Available for licensing.
Licensing Contacts: Uri Reichman, PhD, MBA; 301-435-4616;
UR7a@nih.gov; or John Stansberry, PhD; 301-435-5236; js852e@nih.gov.
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize the NMRPipe
software system. Please contact Cindy Fuchs at 301-451-3636 or Frank
Delaglio at frankde@niddk.nih.gov for more information.
Target Activated Microdissection--Kits and High Throughput Applications
Description of Invention: A variety of techniques have been used to
microdissect specific cells or cell populations from a histological
sample under direct microscopic visualization. Original microdissection
techniques involved painstaking (and sometimes clumsy) manual
dissection using needles or other micro-manipulation
[[Page 29765]]
devices to isolate individual cells based on visible, histological
characteristics.
The subject technology is a novel method of performing specific
target activated transfer from a biological sample (i.e. tissue) for
analysis using a device system that can be automated for high
throughput analysis or using benchtop kits. The method employs a
localized reagent, such as an absorbative stain or immunoreagent that
specifically determines the microadhesion of desired cellular material
in a tissue sample to a transfer surface such as a thermoplastic
polymer film. The energy from a light or heat source causes the
specific microadhesion of the target cells or cell populations to the
thermoplastic transfer surface without damage to the cells. Subsequent
separation of the film from the tissue section selectively removes the
adhered target from the tissue section. The method is specific and
eliminates the need for direct manual visualization. Kits based on the
method have the distinct advantage of not requiring expensive
equipment; and thus, are a cost effective option for microdissection
and analysis.
Applications:
Microdissection and analysis kits for histological
samples.
High throughput analysis of biological samples.
Advantages:
Does not require a visual detection step.
Kits based on the method are low cost options for
microdissection.
Automated high throughput microdissection and analysis
capabilities.
Development Status: In vitro data can be provided upon request.
Inventors: Michael R. Emmert-Buck (NCI), Robert F. Bonner (NICHD),
et al.
Publications:
1. Tangrea MA, Chuaqui RF, Gillespie JW, Ahram M, Gannot G, Wallis
BS, Best CJ, Linehan WM, Liotta LA, Bonner RF, Emmert-Buck MR.
Expression microdissection: operator-independent retrieval of cells for
molecular profiling. Diagn Mol Pathol. 2004 Dec;13(4):207-212. [PubMed:
15538110]
2. Grover A, Woodson KA, Tangrea MA, Wallis BS, Hanson J, Chuaqui
RF, Gillespie JW, Erickson HS, Bonner RF, Pohida T, Emmert-Buck MR,
Libutti SK. Tumor-associated endothelial cells display GSTP1 and RAR
beta2 promoter methylation in human prostate cancer. J Translational
Med. 2006 Mar 2;4:13. [PubMed: 16512911]
3. Hanson JC, Rodriguez-Canales J, Bonner RF, Pohida T, Tangrea MT,
Emmert-Buck MR. Expression Microdissection Adapted to Commercial Laser
Dissection Instruments (Submitted for publication).
Patent Status:
HHS Reference No. E-113-2003/0--
U.S. Patent Application No. 10/543,218 filed 22 Jul 2005,
allowed.
U.S. Patent Application No. 12/753,566 filed 02 Apr 2010.
Australian Patent 2003256803 issued 21 Jan 2010.
Australian Patent Application No. 2009250964 filed 23 Jul
2009.
Canadian Patent Application No. 2513646 filed 23 Jun 2003.
HHS Reference No. E-113-2003/1--
U.S. Patent 7,695,752 issued 13 Apr 2010.
U.S. Patent Application No. 12/713,105 filed 24 Feb 2010.
Licensing Status: Available for licensing.
Licensing Contact: Kevin W. Chang, PhD; 301-435-5018;
changke@mail.nih.gov.
Therapeutic HIV Vaccine and Associated Protocols
Description of Invention: This technology describes a therapeutic
HIV DNA vaccine to be administered to individuals who have previously
experienced or are undergoing antiretroviral therapy (ART). The
therapeutic DNA vaccine can also be administered in combination with a
vector encoding an IL-15 and/or IL-15 receptor alpha (IL-15Ra)
polypeptide. In primate studies, the technology was found to be
particularly effective when the vaccine composition was administered by
electroporation and expressed six (6) HIV antigens (including two (2)
gag polypeptides and two (2) envelope polypeptides) and IL-15 and IL-
15Ra. The antigens are typically modified with a destabilizing
sequence, a secretory polypeptide and/or a degradation signal.
Successive administration up to as many as nine resulted in continual
boost of the immune response against the encoded antigen. A potent
immunotherapeutic vaccine as described here could be an important
technology for the fight against HIV/AIDS.
Applications: Therapeutic HIV DNA vaccines.
Development Status: Primate data available.
Inventors: Barbara Felber et al. (NCI).
Patent Status:
U.S. Patent Application No. 12/522,775 filed 10 Jul 2009,
claiming priority to 12 Jan 2007 (HHS Reference No. E-103-2007/0-US-
03).
U.S. Patent Application No. 12/160,263 filed 08 Jul 2008,
claiming priority to 13 Jan 2006 (HHS Reference No. E-254-2005/2-US-
12); and related international patent applications.
U.S. Patent Application No. 11/571,879 filed 09 Jan 2007,
claiming priority to 09 Jul 2004 (HHS Reference No. E-249-2004/1-US-
02).
U.S. Patent Application No. 12/426,901 filed 20 Apr 2009,
claiming priority to 01 Nov 2000 (HHS Reference No. E-308-2000/0-PCT-
02); and related international patent/patent applications.
Licensing Status: Available for licensing.
Licensing Contact: Kevin W. Chang, PhD; 301-435-5018;
changke@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 HIV DNA vaccines. Please contact John D. Hewes, PhD at
301-435-3121 or hewesj@mail.nih.gov for more information.
A Novel Chimeric Bifunctional Protein for Prevention and Treatment of
HIV Infection
Description of Invention: This invention relates to bifunctional
fusion proteins effective in HIV neutralization. Specifically, the
invention is a genetically engineered chimeric protein composed of a
soluble extracellular region of human CD4 (sCD4) attached via a
flexible polypeptide linker to a single-chain construct of a human
monoclonal antibody directed against a CD4-induced, highly conserved
gp120 determinant involved in co-receptor interaction and virus entry.
Mechanistically, the binding of the sCD4 moiety to the HIV gp120 Env
glycoprotein induces a conformational change that enables the antibody
moiety to bind, thereby blocking Env function and virus entry. This
novel design provides the protein with unique characteristics that
enables its extremely strong binding to gp120, thus rendering it a
potential effective antiviral agent against HIV. Recent studies
(Lagenaur et al. Retrovirology 7:11, 2010) indicate that this novel
bispecific protein displays extremely broad neutralizing activity
against genetically diverse primary HIV-1 isolates, with breadth much
greater than previously described (Dey et al. J. Virology 77:2859,
2003). The potency is generally at least 10-fold greater than the best
described HIV-1 neutralizing monoclonal antibodies, and the protein is
highly active against many HIV-1 isolates that are refractory to
neutralization by these antibodies. The bifunctional protein is
comparably potent against isogenic virions produced from a human cell
line versus PBMC; by contrast, the broadly-reactive monoclonal
antibodies are much less
[[Page 29766]]
potent against virions produced from PBMC, perhaps due to differences
in glycosylation. Importantly, the bifunctional protein is composed of
almost entirely human sequences. It potentially can be linked to other
functional moieties to achieve desired properties (longer plasma half-
life, selective killing of HIV-infected cells, imaging of viral
reservoirs, etc.).
The chimeric protein of this invention has considerable potential
for prevention of HIV-1 infection, both as a topical microbicide and as
a systemic agent to protect during and after acute exposure (e.g.
vertical transmission, post exposure prophylaxis). It also has
potential utility for treatment of chronic infection, including gene
therapy strategies involving hematopoietic stem cells and/or viral
vectors. Such proteins, nucleic acid molecules encoding them, and their
production and use in preventing or treating viral infections are
claimed in the patents issued for this invention.
Applications:
Prophylactic and/or therapeutic treatment for HIV
infection.
Topical microbicide treatment to protect against HIV
infection.
Imaging of HIV infected cells in tissues.
Advantages:
High neutralization efficiency due to unique bifunctional
binding characteristics.
Potentially minimally immunogenic or toxic (human
sequences and possibly low treatment doses).
Broad neutralizing activity.
Mechanism of action less susceptible to resistance.
Development Status:
Reproducible production and scale-up of chimeric protein
has been demonstrated.
Potent and broad neutralization of genetically diverse
HIV-1 clinical isolates was demonstrated.
Market: The race to develop effective antiviral strategies against
HIV infection is ongoing. The problems exhibited by conventional drugs
such (i.e. toxicity and resistance) have triggered the pursuit of
alternative approaches to HIV/AIDS prevention and treatment. One of the
new approaches is the development of neutralizing antibodies against
the HIV envelope proteins. This approach has not yet yielded any
commercially viable treatment. It is believed that the approach
presented in the subject invention will circumvent many of the
shortcomings of the existing drugs and other pursued approaches. If
this approach is successful the commercial rewards will be huge because
of the global magnitude of HIV epidemics.
Inventor: Edward A. Berger (NIAID).
Related Publications:
1. Lagenaur LA, Villarroel VA, Bundoc V, Dey B, Berger EA. sCD4-17b
bifunctional protein: Extremely broad and potent neutralization of HIV-
1 pseudotyped viruses from genetically diverse primary isolates.
Retrovirology 2010 Feb 16; 7:11. [PubMed: 20158904]
2. Dey B, Del Castillo CS, Berger EA. Neutralization of human
immunodeficiency virus type 1 by sCD4-17b, a single-chain chimeric
protein, based on sequential interaction of gp120 with CD4 and
coreceptor. J Virol. 2003 March; 77(5):2859-2865. [PubMed: 12584309]
Patent Status:
HHS Reference No. E-039-1999/0--
U.S. Patent No. 7,115,262, issued 03 Oct 2006.
U.S. Application No. 11/535,957, filed 27 Sep 2006,
published 18 Oct 2007 as 20070243208.
Australian Patent No. 765218, issued 30 Jul 2003.
European Patent No. 1161445 issued 03 Sep 2008 for France,
Germany, Great Britain, Italy.
Applications pending in Canada, Japan.
Licensing Status: Available for licensing.
Licensing Contacts: Uri Reichman, PhD, MBA; 301-435-4616;
ur7a@nih.gov; or Susan Ano, PhD, 301-435-5515; anos@mail.nih.gov.
Collaborative Research Opportunity: The NIAID, Office of Technology
Development, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize ``A Novel Chimeric Protein for Prevention
and Treatment of HIV Infection.'' Please contact Marguerite J. Miller
at 301-435-8619 for more information.
Dated: May 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-12794 Filed 5-26-10; 8:45 am]
BILLING CODE 4140-01-P
