Government-Owned Inventions; Availability for Licensing, 41440-41443 [E9-19693]
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Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Citation
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Total
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1There
186
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents in table 1 is based on the
number of regulatory submissions
submitted to TTB for beers that do not
meet the definition of a ‘‘malt beverage’’
under the FAA Act. Based on its records
of submissions received from
manufacturers of such products, TTB
estimates the number of respondents to
be 12 and the number of submissions
annually to be 25. Thus, FDA adopts
TTB’s estimate of 12 respondents, and
an annual frequency per response of 2,
in table 1 of this document.
FDA’s estimate of the hours per
response for each regulation is based on
FDA’s experience with food labeling
under the agency’s jurisdiction. The
estimated hours per response for
§§ 101.3, 101.4, 101.5, 101.9, 101.22,
and 101.105 in table 1 of this document
are equal to, and based upon, the
estimated hours per response approved
by OMB in OMB Control No. 0910–
0381. FDA further estimates that the
labeling burden of section 403(w)(1) of
the FD&C Act, which specifies
requirements for the declaration of food
allergens, will be 1 hour based upon the
similarity of the requirements to that of
§ 101.4. Finally, FDA estimates that a
respondent will spend 1 hour reading
the guidance document, once finalized.
Thus, FDA estimates that 12
respondents will each label two
products annually, for a total of 24
labels. FDA estimates that the
manufacturers will spend 7.25 hours
(0.5 hours + 1 hour + 0.25 hour + 4
hours + 0.5 hour + 1 hour = 7.25 hours)
on each label to comply with FDA’s
labeling regulations and the
requirements of section 403(w)(1), for a
total of 174 hours (24 labels x 7.25 hours
= 174 hours). In addition, 12
respondents will each spend 1 hour
reading the guidance document, for a
total of 12 hours. Thus, FDA estimates
the total hour burden of the proposed
collection of information to be 186
hours (174 hours + 12 hours = 186
hours).
Before the proposed information
collection provisions contained in this
draft guidance become effective, FDA
will publish a notice in the Federal
Register announcing OMB’s decision to
approve, modify, or disapprove the
information collection provisions. An
agency may not conduct or sponsor, and
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a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in
§§ 101.3, 101.4, 101.5, 101.9, 101.22,
and 101.105 have been approved under
OMB Control No. 0910–0381.
III. Comments
Interested persons may submit written
or electronic comments regarding this
draft guidance document, including
comments regarding the proposed
collection of information. Written
comments should be submitted to the
Division of Dockets Management (see
ADDRESSES). Electronic comments
should be submitted to https://
www.regulations.gov. Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/FoodGuidances.
V. References
We have placed the following
references on display in the Division of
Dockets Management (see ADDRESSES).
The references may be seen between 9
a.m. and 4 p.m., Monday through
Friday. FDA has verified the Web site
addresses, but it is not responsible for
any subsequent changes to the Web site
addresses after this document publishes
in the Federal Register.
1. FDA Compliance Policy Guide (CPG)
7101.04 (Dealcoholized Wine and Malt
Beverages- Labeling), available at https://
www.fda.gov/ICECI/ComplianceManuals/
CompliancePolicyGuidanceManual/
ucm074430.htm and CPG 7101.05 (Labeling
—Diluted Wines and Cider with Less Than
7% Alcohol), available at https://
www.fda.gov/ICECI/ComplianceManuals/
CompliancePolicyGuidanceManual/
ucm074431.htm.
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2. Memorandum of Understanding 225–
88–2000 between FDA and Bureau of
Alcohol, Tobacco and Firearms, available at
https://www.fda.gov/AboutFDA/Partnerships
Collaborations/MemorandaofUnderstanding
MOUs/DomesticMOUs/ucm116370.htm.
3. TTB Ruling 2008–3 dated July 7, 2008,
available at https://www.fda.gov/AboutFDA/
PartnershipsCollaborations/Memorandaof
UnderstandingMOUs/DomesticMOUs/
ucm116370.htm.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19640 Filed 8–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Development of a New Carbohydrate
Antibody to GalNac1–3Gal
Description of Technology: The
present invention provides a
monoclonal antibody that binds
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Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
specifically to the antigen GalNAc1–
3Gal present in human cancers,
including squamous cell cancer, human
cervical cancer, human esophageal
cancer, human laryngeal cancer, and
human skin cancer. The antibody can be
used to monitor expression of this
carbohydrate for a variety of purposes.
In immunohistochemical staining of
tissues, the antibody stains a variety of
carcinomas, with good staining of
cervical, larynx, and skin squamous cell
carcinomas. Positive antibody staining
of cervical cancer tissue correlates with
a good prognosis (increased 5 year
survival rate) and as such may be useful
as a prognostic marker. NCI also has the
parent cell line for production of the
antibody and several other variant
antibodies with similar reactivity.
Applications
• Cervical cancer diagnostics and
prognosis.
• A research tool.
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Market
• Cancer is the second leading cause
of death in the U.S.A. There is an acute
need for cancer biomarkers that can be
detected from clinically relevant
samples and used for early diagnosis,
therapeutic follow-up and prognosis of
malignant diseases.
• Estimated new cases and deaths
from cervical (uterine cervix) cancer in
the United States in 2009: 11,270 new
cases; 4,070 deaths according to the
National Cancer Institute.
Inventors: Jeffrey C. Gildersleeve et al.
(NCI).
Patent Status: U.S. Provisional
Application No. 61/165, 675 filed 01
Apr 2009 (HHS Reference No. E–058–
2009/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov.
Deletion of the Beta 20–21 Loop in HIV
GP120 Exposes the CD4 Binding Site for
Improved Antibody Binding and
Antibody
Description of Technology: With the
number of individuals infected with
HIV approaching nearly one percent
(1%) of the world’s population, an
effective vaccine is urgently needed. As
an enveloped virus, HIV hides most of
its proteins and genes from humoral
recognition behind a protective lipid
bilayer. An available exposed viral
target for neutralizing antibodies is the
envelope spike. Genetic, immunologic
and structural studies of the HIV
envelope glycoproteins have revealed
extraordinary diversity as well as
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multiple overlapping mechanisms of
humoral evasion, including selfmasquerading glycan, immunodominant
variable loops, and conformational
masking. These evolutionarily-honed
barriers of antigenic diversity and
immune evasion have confounded
traditional means of vaccine
development. It is believed that
immunization with effectively
immunogenic HIV gp120 envelope
glycoprotein can elicit a neutralizing
response directed against gp120, and
thus HIV. The need exists for
immunogens that are capable of eliciting
a protective immune response.
This application claims isolated
immunogens, including variant gp120
polypeptides and the use of these
polypeptides to induce an immune
response to HIV. This application also
claims virus-like particles including the
variant gp120 polypeptides. More
specifically, this application claims
virus-like particles including variant
gp120–HBsAg hybrid constructs, which
may also include at least one TLR
ligand.
Application: Development of Human
Immunodeficiency Virus (HIV)
vaccines, therapeutics and diagnostics.
Advantages: VLP gp120 vaccine, use
of HBsAg vector for delivery.
Development Status: Vaccine
candidates have been synthesized and
preclinical studies have been
performed.
Inventor: Ira Berkower (FDA).
Publication: I Berkower et al. Targeted
deletion in the beta20-beta21 loop of
HIV envelope glycoprotein gp120
exposes the CD4 binding site for
antibody binding. Virology. 2008 Aug
1;377(2):330–338.
Patent Status: U.S. Provisional
Application 61/155,782 filed 26 Feb
2009 (HHS Reference No. E–299–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Multilayered RF Coil System for
Improving Transmit B1 Field
Homogeneity in High-Field MRI
Description of Technology: Available
for licensing and commercial
development is a multilayered radiofrequency (RF) coil system for
improving the transmit B1 field
homogeneity for magnetic resonance
imaging (MRI) at high field strengths.
The current invention aims at
manipulating the inhomogeneous
profile of the transmit B1 field, which
causes MR images to become less
uniform as the magnetic field strength is
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41441
increased, by utilizing an inner array of
RF elements (e.g. surface coils) within
and coupled to an outer transmit unit
(e.g. a birdcage coil or other volume
coil). Improvement in B1 field
homogeneity is achieved by tuning the
surface coils of the inner layer to an
appropriate resonant frequency and
then passively coupling them to the
outer-layer volume coil. Furthermore,
the amount of coupling is determined
by the intrinsic properties of the
transmit unit and can be adjusted
accordingly. The current design
provides an effective approach for
reducing B1 field homogeneity at high
fields and can be implemented without
the need for independent RF channels,
thereby reducing MRI system
complexity. Furthermore it can be
readily implemented on existing MRI
coil systems by detuning surface coils
rather than decoupling them during the
transmit phase.
Applications
• High-Field MRI.
• Improvement of MR Image
Uniformity.
Market: Manufacturers of MRI
hardware and accessories.
Development Status: The technology
is ready to be used and requires only
testing in humans for development.
Inventors: Alan Koretsky, Jeff Duyn,
Shumin Wang, Hellmut Merkle
(NINDS).
Publications
1. S Wang and JH Duyn, ‘‘ThreeDimensional Automatic Mesh Generation for
Hybrid Electromagnetic Simulations’’, IEEE
Antennas and Propagation Magazine, Vol. 51,
pp. 71–85, April 2009.
2. H Merkle, J Murphy-Boesch, S Wang, P
van Gelderen, AP Koretsky, and JH Duyn,
‘‘Graded Transmit B1 Field Correction at 7T
Using Tunable Inner Elements’’, ISMRM
High-field Workshop, Rome, Italy, October
2008.
3. H Merkle, S Wang, P van Gelderen, TQ
Li, J Murphy-Boesch, AP Koretsky, and JH
Duyn, ‘‘B1 Transmit Field Correction at 7T
Using Coupled Inner Elements’’, ISMRM
2008, Toronto, Canada, May, 2008.
4. S Wang, H Merkle, AP Koretsky, and JH
Duyn, ‘‘Improving High-Field Transmit B1
Field Homogeneity Using Coupled Inner
Elements’’, 15th Scientific Meeting and
Exhibition, International Society for
Magnetic Resonance in Medicine, Berlin,
Germany, May 2007.
Patent Status
• U.S. Provisional Application No.
60/900,972 filed 13 Feb 2007 (HHS
Reference No. E–020–2007/0–US–01).
• PCT Application No. PCT/US2008/
001911 filed 13 Feb 2008 (HHS
Reference No. E–020–2007/0–PCT–02).
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Licensing Status: Available for
licensing.
Licensing Contact: John Stansberry,
Ph.D.; 301/435–5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity:
The Laboratory of Functional and
Molecular Imaging (LFMI) at the
National Institute of Neurological
Disorders and Stroke (NINDS) is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize MRI applications that
aim to provide novel functional and
molecular imaging techniques to study
brain structure and function. Please
contact Melissa Maderia, Ph.D. at
maderiam@mail.nih.gov or 301–451–
3943 for more information.
Quantifying Gene Relatedness via
Nonlinear Prediction of Gene
Expression Levels
Description of Technology: This
invention relates to a new way to
analyze the function of a newly
identified gene. Working together, the
genes within a genomic system
constitute a control system for
modulating gene expression activity and
protein production. Regulation within
this control system depends on
multivariate relations among genes.
Therefore, a key window into
understanding genomic activity is to
quantify the manner in which the
expression profile among a set of genes
can be used to predict the expression
levels of other genes. This invention
provides the experimental, statistical,
and computational basis for nonlinear
and linear multivariate prediction and
co-determination among gene
expression levels, and it is applied in
the context of cDNA microarrays. Using
these measures of multi-gene
interactivity, it is possible to infer
genomic regulatory mechanisms and
thereby identify the manner in which
genetic malfunction contributes to
cancer and developmental anomalies.
Inventors: Michael Bittner (NHGRI),
Yidong Chen (NHGRI), et al.
Patent Status: U.S. Patent No.
7,003,403 issued 21 Feb 2006 (HHS
Reference No. E–059–2000/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jeffrey A. James,
Ph.D.; 301–435–5474;
jeffreyja@mail.nih.gov.
Isolated Helicobacter hepaticus
Description of Technology: An
isolated bacterium of the genus
Helicobacter, characterized by the 16S
ribosomal RNA encoding nucleotide
sequence defined in the Sequence
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Listing as SEQ ID NO:1 is provided. An
isolated nucleic acid having the
nucleotide sequence defined in the
Sequence Listing as SEQ ID NO:1 is
provided. Such a nucleic acid can be
used for diagnosis of infection with H.
hepaticus. A nucleic acid of the present
invention in a vector suitable for
expression of the nucleic acid is also
provided. The vector can be in a host
suitable for expressing the nucleic acid.
A purified antigen specific for H.
hepaticus is provided. A method of
making an animal model for chronic
Helicobacter infection is also provided.
Inventors: Jerrold M. Ward et al.
(NCI).
Patent Status: U.S. Patent 5,610,060
issued 11 Mar 1997 (HHS Reference No.
E–010–1994/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jeffrey A. James,
Ph.D.; 301–435–5474;
jeffreyja@mail.nih.gov.
Recombinant Vaccines Based on
Poxvirus Vectors
Description of Technology: The
technology offered for licensing is
foundational in the area of recombinant
DNA vaccines. In the last several years,
facilitated through a licensing program
of the NIH, the technology has been
broadly applied in the development and
commercialization of several novel
human and veterinary vaccines in the
areas of infectious disease as well as
cancer therapeutics. The NIH wishes to
expand its licensing program of the
subject technology in a variety of
applications that will benefit public
health.
Briefly, the technology describes and
claims methods of constructing
recombinant vaccines utilizing any
recombinant poxvirus, and in particular
vaccinia virus (i.e. Modified Vaccinia
Ankara or other strains) as a backbone
that carries a foreign DNA. The foreign
DNA can be related to a viral pathogen
for example, or to a tumor-associated
antigen. Upon administration of the
recombinant virus to a human or animal
subject, the foreign gene is expressed in
vivo to elicit an immune response
against the respective pathogen or the
respective tumor.
The technology takes advantage of the
unique properties of poxviruses as a
delivering vehicle and of the ease of
preparation of such constructs.
The applications of this technology
have been extensively covered by many
publications, including more than 100
publications from the inventor (see
sampling below). The publications
cover a wide variety of vaccines such as
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HIV, papilloma virus, influenza and
others.
Note: Samples of plasmids and vaccinia
virus used in the invention are deposited in
the American Type Culture Collection and in
the NIH and may be available for licensees
upon request.
Applications
• Prophylactic and/or therapeutic
vaccines.
• Infectious disease and cancer
Human and animal vaccines.
• Immunotherapy.
• Protein expression system.
Advantages: Recombinant Poxviruses
vectors in DNA vaccines have exhibited
some advantages as compared to other
viral vectors such as adenovirus,
retrovirus or papillomavirus:
• High safety profile.
• Wide host range.
• Ability to accommodate large
amounts of foreign DNA including
multiple genes.
• No loss of infectivity upon insertion
of foreign DNA.
• Unique transcriptional regulatory
signals of the virus facilitates flexibility
in genome strategy.
In addition, the following properties
have been demonstrated:
• Immunization with vacciniavectored vaccines provides long-lasting
protection.
• Vaccinia virus is very stable and no
cold-chain is required in distribution
network.
• Induce mucosal immune response.
• Induce humeral and cellular
immunity.
Development Status: Fully developed.
The technology has been already
successfully implemented in
commercial veterinary vaccines (i.e.
rabies) and is in advance clinical trials
in several companies in the area of
cancer immunotherapy.
Market
• The market for vaccines against
infectious diseases is in the multibillion
dollars and keeps growing at an annual
rate of approximately 40%. This is
compared to approximately 8% growth
for the overall pharmaceutical
companies. Live recombinant vaccines
as offered in the subject technology offer
an attractive alternative to existing
vaccines as well as for future vaccines
and therefore may be commercially
attractive for vaccine and
pharmaceutical companies.
• The market for therapeutic cancer
vaccines, which is the subject of this
technology, is expected to mirror the
growth seen in the monoclonal antibody
market and reach sales in excess of $5
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Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
Dated: August 10, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–19693 Filed 8–14–09; 8:45 am]
1. B Moss and PL Earl. Overview of the
vaccinia virus expression system. Curr Protoc
Mol Biol. 2002 Nov; Chapter 16: Unit16.15.
2. HL Robinson, S Sharma, J Zhao, S
Kannanganat, L Lai, L Chennareddi, T Yu,
DC Montefiori, RR Amara, LS Wyatt, B Moss.
Immunogenicity in macaques of the clinical
product for a clade B DNA/MVA HIV
vaccine: elicitation of IFN-gamma, IL–2, and
TNF-alpha coproducing CD4 and CD8 T
cells. AIDS Res Hum Retroviruses. 2007
Dec;23(12):1555–1562.
3. LS Wyatt, PL Earl, J Vogt, LA Eller, D
Chandran, J Liu, HL Robinson, B Moss.
Correlation of immunogenicities and in vitro
expression levels of recombinant modified
vaccinia virus Ankara HIV vaccines. Vaccine
2008 Jan 24;26(4):486–493.
4. M Hebben, J Brants, C Birck, JP Samama,
B Wasylyk, D Spehner, K Pradeau, A Domi,
B Moss, P Schultz, R Drillien. High level
protein expression in mammalian cells using
a safe viral vector: modified vaccinia virus
Ankara. Protein Expr Purif. 2007
Dec;56(2):269–278.
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billion by 2012 according to some
reports.
Overall, the potential commercial
opportunity based on the subject
technology is immense.
Inventors: Bernard Moss et al.
(NIAID).
Publications: The inventor, Dr.
Bernard Moss, is an author of more than
100 publications in the area covered by
the subject patents. The following is just
a sampling of his publications in the
area:
Government-Owned Inventions;
Availability for Licensing
Patent Status: The technology is
described and claimed in the following
four (4) patents that were issued in the
U.S. in 2006 (HHS Reference E–552–
1982/2):
1. USPN 6,998,252 issued February
14, 2006, ‘‘Recombinant Poxviruses
Having Foreign DNA Expressed under
the Control of Poxvirus Regulatory
Sequences’’.
2. USPN 7,015,024 issued March 21,
2006, ‘‘Compositions Containing
Recombinant Poxviruses Having Foreign
DNA Expressed Under the Control of
Poxvirus Regulatory Sequences’’.
3. USPN 7,045,313 issued May 16,
2006, ‘‘Recombinant Vaccinia Virus
Containing Chimeric Gene Having
Foreign DNA Flanked by Vaccinia
Regulatory DNA’’.
4. USPN 7,045,136 issued May 16,
2006, ‘‘Methods of Immunization Using
Recombinant Poxviruses Having Foreign
DNA Expressed Under the Control of
Poxvirus Regulatory Sequences’’.
Licensing Status: Available for
licensing.
Licensing Contacts: Uri Reichman,
Ph.D., MBA; 301–435–4616;
ur7a@nih.gov; RC Tang, JD, LLM; 301–
435–5031; tangrc@mail.nih.gov.
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Superior Method of Preparing
Dendrimers for Use as Magnetic
Resonance Imaging (MRI) Contrast
Agents
Description of Technology: There is a
need to develop more efficient
gadolinium-containing (Gd) contrast
agents for magnetic resonance imaging
(MRI) as the small molecules presently
used clinically have the disadvantage of
being rapidly cleared from circulation
and excreted by the kidneys.
Dendrimer-based macromolecular
MRI contrast agents in which numerous
chelated Gd ions are covalently attached
to a multivalent dendritic architecture
are a promising class of diagnostic
agents for medical imaging applications.
Clinical development of the dendrimerbased agents has been limited as the
current methods for synthesizing them
result in a complex mixture that
produces inconsistent imaging results.
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41443
The present technology describes the
development of a new method of preforming the metal-ligand chelate in
alcohol prior to conjugation to the
dendrimer. Specifically, for example, a
1B4M–DTPA–Gd chelate is preformed
in methanol and purified prior to
conjugation to a PAMAM dendrimer
molecule. This results in a dendrimerbased MRI contrast agent with greatly
improved homogeneity and stability,
and possessing an unexpectedly greater
molar relaxivity that allows the use of
much less of the agent than previously
required to obtain comparable images.
The use of a DOTA–Gd chelate is
equally possible.
Application: An improved method for
synthesis of dendrimer-based MRI
contrast agents that is greatly suited for
clinical development.
Advantages
• Efficient preparation of stable
dendrimer-based contrast agents
suitable for medical imaging.
• Higher molar relaxivity translates
into a lower dosage needed for imaging.
• Ability to control dendrimer size
conducive for development of
compartment-specific imaging agents.
Market: Dendrimers show particular
promise for the development of cancer
imaging agents. The ability to
exquisitely control dendrimer size
enables delivering them to specific
compartments such as small tumors
allowing for early cancer detection.
Gadolinium (Gd) chelates are
extensively used as MRI contrast agents
and have proven to be safe. The
combination of gadolinium chelates
with dendrimer chemistry could greatly
enhance the versatility of MRI imaging.
Inventors: Kido Nwe and Martin W.
Brechbiel (NCI).
Publications
1. K Nwe, H Xu, CA Regino, M Bernardo, L
Ileva, L Riffle, KJ Wong, MW Brechbiel.
A new approach in the preparation of
dendrimer-based bifunctional
diethylenetriaminepentaacetic acid MR
contrast agent derivatives. Bioconjugate
Chem. 2009 Jul;20(7):1412–1418.
2. OA Gansow, MW Brechbiel, MA
Magerstadt. Complexes of functionalized
tetraazacyclododecane chelates with
bismuth, lead, yttrium, actinium, or
lanthanide metal ions. U.S. Patent
5,428,154 issued 27 Jun 1995.
Patent Status: U.S. Provisional
Application No. 61/180,327 filed 21
May 2009 (HHS Reference No. E–207–
2009/0–US–01).
Related Technology: OA Gansow, MW
Brechbiel, MA Magerstadt, ‘‘Complexes
of Functionalized
Tetraazacyclododecane Chelates with
Bismuth, Lead, Yttrium, Actinium, or
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]]>Agencies
[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Pages 41440-41443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19693]
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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.
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.
Development of a New Carbohydrate Antibody to GalNac1-3Gal
Description of Technology: The present invention provides a
monoclonal antibody that binds
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specifically to the antigen GalNAc1-3Gal present in human cancers,
including squamous cell cancer, human cervical cancer, human esophageal
cancer, human laryngeal cancer, and human skin cancer. The antibody can
be used to monitor expression of this carbohydrate for a variety of
purposes. In immunohistochemical staining of tissues, the antibody
stains a variety of carcinomas, with good staining of cervical, larynx,
and skin squamous cell carcinomas. Positive antibody staining of
cervical cancer tissue correlates with a good prognosis (increased 5
year survival rate) and as such may be useful as a prognostic marker.
NCI also has the parent cell line for production of the antibody and
several other variant antibodies with similar reactivity.
Applications
Cervical cancer diagnostics and prognosis.
A research tool.
Market
Cancer is the second leading cause of death in the U.S.A.
There is an acute need for cancer biomarkers that can be detected from
clinically relevant samples and used for early diagnosis, therapeutic
follow-up and prognosis of malignant diseases.
Estimated new cases and deaths from cervical (uterine
cervix) cancer in the United States in 2009: 11,270 new cases; 4,070
deaths according to the National Cancer Institute.
Inventors: Jeffrey C. Gildersleeve et al. (NCI).
Patent Status: U.S. Provisional Application No. 61/165, 675 filed
01 Apr 2009 (HHS Reference No. E-058-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov.
Deletion of the Beta 20-21 Loop in HIV GP120 Exposes the CD4 Binding
Site for Improved Antibody Binding and Antibody
Description of Technology: With the number of individuals infected
with HIV approaching nearly one percent (1%) of the world's population,
an effective vaccine is urgently needed. As an enveloped virus, HIV
hides most of its proteins and genes from humoral recognition behind a
protective lipid bilayer. An available exposed viral target for
neutralizing antibodies is the envelope spike. Genetic, immunologic and
structural studies of the HIV envelope glycoproteins have revealed
extraordinary diversity as well as multiple overlapping mechanisms of
humoral evasion, including self-masquerading glycan, immunodominant
variable loops, and conformational masking. These evolutionarily-honed
barriers of antigenic diversity and immune evasion have confounded
traditional means of vaccine development. It is believed that
immunization with effectively immunogenic HIV gp120 envelope
glycoprotein can elicit a neutralizing response directed against gp120,
and thus HIV. The need exists for immunogens that are capable of
eliciting a protective immune response.
This application claims isolated immunogens, including variant
gp120 polypeptides and the use of these polypeptides to induce an
immune response to HIV. This application also claims virus-like
particles including the variant gp120 polypeptides. More specifically,
this application claims virus-like particles including variant gp120-
HBsAg hybrid constructs, which may also include at least one TLR
ligand.
Application: Development of Human Immunodeficiency Virus (HIV)
vaccines, therapeutics and diagnostics.
Advantages: VLP gp120 vaccine, use of HBsAg vector for delivery.
Development Status: Vaccine candidates have been synthesized and
preclinical studies have been performed.
Inventor: Ira Berkower (FDA).
Publication: I Berkower et al. Targeted deletion in the beta20-
beta21 loop of HIV envelope glycoprotein gp120 exposes the CD4 binding
site for antibody binding. Virology. 2008 Aug 1;377(2):330-338.
Patent Status: U.S. Provisional Application 61/155,782 filed 26 Feb
2009 (HHS Reference No. E-299-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646;
soukasp@mail.nih.gov.
Multilayered RF Coil System for Improving Transmit B1 Field Homogeneity
in High-Field MRI
Description of Technology: Available for licensing and commercial
development is a multilayered radio-frequency (RF) coil system for
improving the transmit B1 field homogeneity for magnetic resonance
imaging (MRI) at high field strengths. The current invention aims at
manipulating the inhomogeneous profile of the transmit B1 field, which
causes MR images to become less uniform as the magnetic field strength
is increased, by utilizing an inner array of RF elements (e.g. surface
coils) within and coupled to an outer transmit unit (e.g. a birdcage
coil or other volume coil). Improvement in B1 field homogeneity is
achieved by tuning the surface coils of the inner layer to an
appropriate resonant frequency and then passively coupling them to the
outer-layer volume coil. Furthermore, the amount of coupling is
determined by the intrinsic properties of the transmit unit and can be
adjusted accordingly. The current design provides an effective approach
for reducing B1 field homogeneity at high fields and can be implemented
without the need for independent RF channels, thereby reducing MRI
system complexity. Furthermore it can be readily implemented on
existing MRI coil systems by detuning surface coils rather than
decoupling them during the transmit phase.
Applications
High-Field MRI.
Improvement of MR Image Uniformity.
Market: Manufacturers of MRI hardware and accessories.
Development Status: The technology is ready to be used and requires
only testing in humans for development.
Inventors: Alan Koretsky, Jeff Duyn, Shumin Wang, Hellmut Merkle
(NINDS).
Publications
1. S Wang and JH Duyn, ``Three-Dimensional Automatic Mesh
Generation for Hybrid Electromagnetic Simulations'', IEEE Antennas
and Propagation Magazine, Vol. 51, pp. 71-85, April 2009.
2. H Merkle, J Murphy-Boesch, S Wang, P van Gelderen, AP
Koretsky, and JH Duyn, ``Graded Transmit B1 Field Correction at 7T
Using Tunable Inner Elements'', ISMRM High-field Workshop, Rome,
Italy, October 2008.
3. H Merkle, S Wang, P van Gelderen, TQ Li, J Murphy-Boesch, AP
Koretsky, and JH Duyn, ``B1 Transmit Field Correction at 7T Using
Coupled Inner Elements'', ISMRM 2008, Toronto, Canada, May, 2008.
4. S Wang, H Merkle, AP Koretsky, and JH Duyn, ``Improving High-
Field Transmit B1 Field Homogeneity Using Coupled Inner Elements'',
15th Scientific Meeting and Exhibition, International Society for
Magnetic Resonance in Medicine, Berlin, Germany, May 2007.
Patent Status
U.S. Provisional Application No. 60/900,972 filed 13 Feb
2007 (HHS Reference No. E-020-2007/0-US-01).
PCT Application No. PCT/US2008/001911 filed 13 Feb 2008
(HHS Reference No. E-020-2007/0-PCT-02).
[[Page 41442]]
Licensing Status: Available for licensing.
Licensing Contact: John Stansberry, Ph.D.; 301/435-5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity: The Laboratory of Functional
and Molecular Imaging (LFMI) at the National Institute of Neurological
Disorders and Stroke (NINDS) is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize MRI applications that aim to
provide novel functional and molecular imaging techniques to study
brain structure and function. Please contact Melissa Maderia, Ph.D. at
maderiam@mail.nih.gov or 301-451-3943 for more information.
Quantifying Gene Relatedness via Nonlinear Prediction of Gene
Expression Levels
Description of Technology: This invention relates to a new way to
analyze the function of a newly identified gene. Working together, the
genes within a genomic system constitute a control system for
modulating gene expression activity and protein production. Regulation
within this control system depends on multivariate relations among
genes. Therefore, a key window into understanding genomic activity is
to quantify the manner in which the expression profile among a set of
genes can be used to predict the expression levels of other genes. This
invention provides the experimental, statistical, and computational
basis for nonlinear and linear multivariate prediction and co-
determination among gene expression levels, and it is applied in the
context of cDNA microarrays. Using these measures of multi-gene
interactivity, it is possible to infer genomic regulatory mechanisms
and thereby identify the manner in which genetic malfunction
contributes to cancer and developmental anomalies.
Inventors: Michael Bittner (NHGRI), Yidong Chen (NHGRI), et al.
Patent Status: U.S. Patent No. 7,003,403 issued 21 Feb 2006 (HHS
Reference No. E-059-2000/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jeffrey A. James, Ph.D.; 301-435-5474;
jeffreyja@mail.nih.gov.
Isolated Helicobacter hepaticus
Description of Technology: An isolated bacterium of the genus
Helicobacter, characterized by the 16S ribosomal RNA encoding
nucleotide sequence defined in the Sequence Listing as SEQ ID NO:1 is
provided. An isolated nucleic acid having the nucleotide sequence
defined in the Sequence Listing as SEQ ID NO:1 is provided. Such a
nucleic acid can be used for diagnosis of infection with H. hepaticus.
A nucleic acid of the present invention in a vector suitable for
expression of the nucleic acid is also provided. The vector can be in a
host suitable for expressing the nucleic acid. A purified antigen
specific for H. hepaticus is provided. A method of making an animal
model for chronic Helicobacter infection is also provided.
Inventors: Jerrold M. Ward et al. (NCI).
Patent Status: U.S. Patent 5,610,060 issued 11 Mar 1997 (HHS
Reference No. E-010-1994/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jeffrey A. James, Ph.D.; 301-435-5474;
jeffreyja@mail.nih.gov.
Recombinant Vaccines Based on Poxvirus Vectors
Description of Technology: The technology offered for licensing is
foundational in the area of recombinant DNA vaccines. In the last
several years, facilitated through a licensing program of the NIH, the
technology has been broadly applied in the development and
commercialization of several novel human and veterinary vaccines in the
areas of infectious disease as well as cancer therapeutics. The NIH
wishes to expand its licensing program of the subject technology in a
variety of applications that will benefit public health.
Briefly, the technology describes and claims methods of
constructing recombinant vaccines utilizing any recombinant poxvirus,
and in particular vaccinia virus (i.e. Modified Vaccinia Ankara or
other strains) as a backbone that carries a foreign DNA. The foreign
DNA can be related to a viral pathogen for example, or to a tumor-
associated antigen. Upon administration of the recombinant virus to a
human or animal subject, the foreign gene is expressed in vivo to
elicit an immune response against the respective pathogen or the
respective tumor.
The technology takes advantage of the unique properties of
poxviruses as a delivering vehicle and of the ease of preparation of
such constructs.
The applications of this technology have been extensively covered
by many publications, including more than 100 publications from the
inventor (see sampling below). The publications cover a wide variety of
vaccines such as HIV, papilloma virus, influenza and others.
Note: Samples of plasmids and vaccinia virus used in the
invention are deposited in the American Type Culture Collection and
in the NIH and may be available for licensees upon request.
Applications
Prophylactic and/or therapeutic vaccines.
Infectious disease and cancer Human and animal vaccines.
Immunotherapy.
Protein expression system.
Advantages: Recombinant Poxviruses vectors in DNA vaccines have
exhibited some advantages as compared to other viral vectors such as
adenovirus, retrovirus or papillomavirus:
High safety profile.
Wide host range.
Ability to accommodate large amounts of foreign DNA
including multiple genes.
No loss of infectivity upon insertion of foreign DNA.
Unique transcriptional regulatory signals of the virus
facilitates flexibility in genome strategy.
In addition, the following properties have been demonstrated:
Immunization with vaccinia-vectored vaccines provides
long-lasting protection.
Vaccinia virus is very stable and no cold-chain is
required in distribution network.
Induce mucosal immune response.
Induce humeral and cellular immunity.
Development Status: Fully developed. The technology has been
already successfully implemented in commercial veterinary vaccines
(i.e. rabies) and is in advance clinical trials in several companies in
the area of cancer immunotherapy.
Market
The market for vaccines against infectious diseases is in
the multibillion dollars and keeps growing at an annual rate of
approximately 40%. This is compared to approximately 8% growth for the
overall pharmaceutical companies. Live recombinant vaccines as offered
in the subject technology offer an attractive alternative to existing
vaccines as well as for future vaccines and therefore may be
commercially attractive for vaccine and pharmaceutical companies.
The market for therapeutic cancer vaccines, which is the
subject of this technology, is expected to mirror the growth seen in
the monoclonal antibody market and reach sales in excess of $5
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billion by 2012 according to some reports.
Overall, the potential commercial opportunity based on the subject
technology is immense.
Inventors: Bernard Moss et al. (NIAID).
Publications: The inventor, Dr. Bernard Moss, is an author of more
than 100 publications in the area covered by the subject patents. The
following is just a sampling of his publications in the area:
1. B Moss and PL Earl. Overview of the vaccinia virus expression
system. Curr Protoc Mol Biol. 2002 Nov; Chapter 16: Unit16.15.
2. HL Robinson, S Sharma, J Zhao, S Kannanganat, L Lai, L
Chennareddi, T Yu, DC Montefiori, RR Amara, LS Wyatt, B Moss.
Immunogenicity in macaques of the clinical product for a clade B
DNA/MVA HIV vaccine: elicitation of IFN-gamma, IL-2, and TNF-alpha
coproducing CD4 and CD8 T cells. AIDS Res Hum Retroviruses. 2007
Dec;23(12):1555-1562.
3. LS Wyatt, PL Earl, J Vogt, LA Eller, D Chandran, J Liu, HL
Robinson, B Moss. Correlation of immunogenicities and in vitro
expression levels of recombinant modified vaccinia virus Ankara HIV
vaccines. Vaccine 2008 Jan 24;26(4):486-493.
4. M Hebben, J Brants, C Birck, JP Samama, B Wasylyk, D Spehner,
K Pradeau, A Domi, B Moss, P Schultz, R Drillien. High level protein
expression in mammalian cells using a safe viral vector: modified
vaccinia virus Ankara. Protein Expr Purif. 2007 Dec;56(2):269-278.
Patent Status: The technology is described and claimed in the
following four (4) patents that were issued in the U.S. in 2006 (HHS
Reference E-552-1982/2):
1. USPN 6,998,252 issued February 14, 2006, ``Recombinant
Poxviruses Having Foreign DNA Expressed under the Control of Poxvirus
Regulatory Sequences''.
2. USPN 7,015,024 issued March 21, 2006, ``Compositions Containing
Recombinant Poxviruses Having Foreign DNA Expressed Under the Control
of Poxvirus Regulatory Sequences''.
3. USPN 7,045,313 issued May 16, 2006, ``Recombinant Vaccinia Virus
Containing Chimeric Gene Having Foreign DNA Flanked by Vaccinia
Regulatory DNA''.
4. USPN 7,045,136 issued May 16, 2006, ``Methods of Immunization
Using Recombinant Poxviruses Having Foreign DNA Expressed Under the
Control of Poxvirus Regulatory Sequences''.
Licensing Status: Available for licensing.
Licensing Contacts: Uri Reichman, Ph.D., MBA; 301-435-4616;
ur7a@nih.gov; RC Tang, JD, LLM; 301-435-5031; tangrc@mail.nih.gov.
Dated: August 10, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-19693 Filed 8-14-09; 8:45 am]
BILLING CODE 4140-01-P
