Government-Owned Inventions; Availability for Licensing, 46641-46642 [E7-16400]
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46641
Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Notices
April 2000. OMB clearance is being
sought for the contact of physicians and
participant proxies to obtain
information about clinical CVD events
that participants experience during the
follow-up period. Frequency of
Response: Once per CVD event. Affected
Public: Individuals. Types of
Respondents: Physicians and selected
proxies of individuals recruited for
MESA. The annual reporting burden is
as follows: Estimated Number of
Estimated
number of
respondents
Type of respondents
Respondents: 550; Estimated Number of
Responses per Respondent: 1.0; and
Estimated Total Annual Burden Hours
Requested: 36.7.
There are no capital, operating, or
maintenance costs to report.
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated
total annual
burden hours
requested
Physicians ..................................................................................................
Participant proxies .....................................................................................
250
300
1.0
1.0
0.20
0.20
16.7
20
Total ....................................................................................................
550
1.0
0.20
36.7
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 will have practical utility;
(2) The accuracy of the agency’s
estimate of 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
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.
To
request more information on the
proposed project or to obtain a copy of
data collection plans and instruments,
contact Dr. Jean Olson, Division of
Prevention and Population Sciences,
NHLBI, NIH, II Rockledge Centre, 6701
Rockledge Drive, Suite 10018, MSC #
7936, Bethesda, MD 20892–7936, or call
non-toll-free number 301–435–0397, or
e-mail your request, including your
address to: olsonj@nhlbi.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.
FOR FURTHER INFORMATION CONTACT:
rmajette on PROD1PC64 with NOTICES
Dated: August 9, 2007.
Michael Lauer,
Chief, Division of Prevention and Population
Sciences, NHLBI, National Institutes of
Health.
Approved: August 9, 2007.
Suzanne Freeman,
NHLBI Project Clearance Officer, National
Institutes of Health.
[FR Doc. E7–16402 Filed 8–20–07; 8:45 am]
BILLING CODE 4140–01–P
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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:
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.
Prophylactic Vaccines and Therapeutic
Monoclonal Antibodies Against
Influenza
Description of Technology: This
technology describes development of
H5N1 influenza vaccine candidates in
which mutations have been introduced
to increase affinity of the hemagglutinin
(HA) for the sialic acid receptor found
in humans, which have a different sialic
acid linkage than the corresponding
avian receptor. These mutations could
therefore result in a higher immune
response in vaccines, producing a more
robust response than other H5N1
vaccine candidates that retain their
PO 00000
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Fmt 4703
Sfmt 4703
avian receptor preferences. These
mutations also changed antibodysensitivity of the vaccine candidates.
The H5 modifications can be expressed
from DNA or adenoviral vectors, or the
proteins themselves can be
administered. Additionally, these
mutated HAs can be used to develop
therapeutic monoclonal antibodies. The
technology describes three (3) unique
monoclonal antibodies that react with
wild-type H5, wild-type H5 and mutant
HA equivalently, and the mutant HA,
respectively.
Applications: Prophylactic influenza
vaccine; Therapeutic antibodies.
Inventors: Gary J. Nabel et al. (VRC/
NIAID).
Patent Status: U.S. Patent Application
No. 60/850,761 filed 10 Oct 2006 (HHS
Reference No. E–306–2006/0–US–01).
U.S. Patent Application No. 60/
860,301 filed 20 Nov 2006 (HHS
Reference No. E–306–2006/1–US–01).
U.S. Patent Application No. 60/
920,874 filed 30 Mar 2007 (HHS
Reference No. E–306–2006/2–US–01).
U.S. Patent Application No. 60/
921,669 filed 02 Apr 2007 (HHS
Reference No. E–306–2006/3–US–01).
Development Status: Animal (mouse)
data available.
Licensing Status: Available for
licensing.
Licensing Contact: Susan Ano, Ph.D.;
301/435–5515; anos@mail.nih.gov.
Antiviral Compounds With Broad
Neutralization Capabilities
Description of Technology: The NIH is
pleased to announce as available for
licensing a technology that provides for
novel antiviral compounds effective
against a broad spectrum of viruses. The
compounds utilize soluble
phospholipases, exemplified by PLA2–X
and others, either alone or as a fusion
protein with a viral binding
polypeptide. These compositions are
able to inactivate viruses through
enzymatic degradation of the viral
membrane without affecting target cells
E:\FR\FM\21AUN1.SGM
21AUN1
46642
Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Notices
rmajette on PROD1PC64 with NOTICES
of infection. The potential broad
application of these compounds could
address a significant health need for
effective antivirals.
Applications: This technology
provides compositions and methods for
the treatment of viral infection and has
human and veterinary applications.
Advantages: The compounds
described by the current technology are
not necessarily specific for a type of
virus or viral strain like many currently
available antiviral compounds, and
therefore have broad therapeutic
antiviral applications. Further, virions
resistant to damage by antibody and
complement have been shown to be
lysed by compounds of the invention
suggesting antiviral surveillance
independent of a humoral immune
response.
Development Status: Proof of concept
in vitro studies using human cells have
shown antiviral activity with viruses
pseudotyped with envelope proteins
from Ebola, HIV, Marburg and
MoMuLV.
Inventors: Gary Nabel and Jae-Ouk
Kim (VRC/NIAID).
Publication: J-O Kim et al. Lysis of
human immunodeficiency virus type 1
by a specific secreted human
phospholipase A2. J Virol. 2007
Feb;81(3):1444–1450.
Patent Status: PCT Application No.
PCT/US2007/004471 filed 21 Feb 2007
(HHS Reference No. E–013–2006/1–
PCT–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Susan Ano, Ph.D.;
301/435–5515; AnoS@mail.nih.gov
Design of Multi-Functional RNA
Nanoparticles and Nanotubes
Description of Invention: The
characteristic function of nanoparticles
is their ability to deliver drug across
biological barriers to the target site
while protecting the drugs from the
biological environment until they reach
the target site. The present invention
provides polyvalent RNA
nanostructures comprising RNA I
inverse (RNA Ii) or RNA II inverse (RNA
IIi) like motifs that have multiple
positions available for conjugation of
therapeutic, diagnostic or delivery
agents. The nanoparticles of the
invention do not induce significant
immune response by themselves and are
smaller than currently available
nanoparticles and therefore allow for
increased efficiency of administration.
The nanoparticles of this invention have
the ability to deliver one or more
different therapeutic agents in a single
particle. Further, the RNA nanoparticles
are also capable of self-assembly into
VerDate Aug<31>2005
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nanotubes of various shapes which offer
potentially broad uses in medical
implants, gene therapy, nanocircuits,
scaffolds and medical testing.
Applications:
1. Use as diagnostic tool.
2. Use as drug delivery composition to
treat various diseases or conditions.
3. Use in screening or identifying
potential chemotherapeutic agents.
4. Use in riboswitch aptamers,
ribozymes or beacons.
5. Use in nanocircuits, medical
implants, gene therapy, scaffolds and
medical testing.
Market: Broad application in various
fields, such as therapeutics, drug
delivery, diagnostics, provides a wide
market potential.
Development Status: Early stage.
Inventors: Bruce A. Shapiro and
Yaroslava G. Yingling (NCI).
Publication: YG Yingling and BA
Shapiro. Computational Design of an
RNA Hexagonal Nanoring and an RNA
Nanotube. Nano Lett. 2007 Jul 6. Epub
ahead of print,.doi 10.1021/nl070984r.
Patent Status: U.S. Provisional
Application No. 60/810,283 filed 02 Jun
2006 (HHS Reference No. E–233–2006/
0–US–01).
U.S. Provisional Application No. 60/
918,181 filed 14 Mar 2007 (HHS
Reference No. E–233–2006/1–US–01).
Licensing Status: Available for
exclusive and non-exclusive licensing.
Licensing Contact: Robert M. Joynes
J.D., M.S.; 301/594–6565;
joynesr@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute’s
Nanobiology Program (https://wwwlecb.ncifcrf.gov/bshapiro/) is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
RNA nanostructures. Please contact
John D. Hewes, Ph.D. at 301–435–3121
or hewesj@mail.nih.gov for more
information.
Methods for Preparing Complex
Multivalent Immunogenic Conjugates
Description of Technology: Claimed in
this application are novel methods for
preparing complex multivalent
immunogenic conjugates and conjugate
vaccines. The multivalent conjugates
and conjugate vaccines are synthesized
by conjugating mixtures of more than
one polysaccharide at a desired ratio of
the component polysaccharides to at
least one carrier protein using hydrazide
chemistry. Because of the high
efficiency of hydrazide chemistry in
conjugation, the polysaccharides are
effectively conjugated to the carrier
protein(s) so that the resulting complex
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
synthesized vaccine conjugate products,
without requiring tedious and
complicated purification procedures
such as chromatography and/or
ammonium sulfate precipitation, are
efficacious in inducing antibodies in
mice against each component
polysaccharide. The methods claimed in
this application simplify the preparation
of multivalent conjugate vaccines by
utilizing simultaneous conjugation
reactions in a single reaction mixture or
batch that includes at least two
immunogenic-distinct polysaccharides.
This single-batch simultaneous reaction
eliminates the need for multiple parallel
synthesis processes for each
polysaccharide vaccine conjugate
component as employed in
conventional methods for making
multivalent conjugate vaccines.
Application: Cost effective and
efficient manufacturing of conjugate
vaccines.
Inventors: Che-Hung Robert Lee
(CBER/FDA).
Patent Status: PCT Application No.
PCT/US2007/006627 filed 16 Mar 2007
(HHS Reference No. E–085–2005/0–
PCT–02).
Licensing Status: Available for
exclusive or non-exclusive licensing.
The technology is not available for
licensing in the field of use of
multivalent meningitis vaccines.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Dated: August 13, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–16400 Filed 8–20–07; 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:
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
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Notices]
[Pages 46641-46642]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16400]
-----------------------------------------------------------------------
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.
Prophylactic Vaccines and Therapeutic Monoclonal Antibodies Against
Influenza
Description of Technology: This technology describes development of
H5N1 influenza vaccine candidates in which mutations have been
introduced to increase affinity of the hemagglutinin (HA) for the
sialic acid receptor found in humans, which have a different sialic
acid linkage than the corresponding avian receptor. These mutations
could therefore result in a higher immune response in vaccines,
producing a more robust response than other H5N1 vaccine candidates
that retain their avian receptor preferences. These mutations also
changed antibody-sensitivity of the vaccine candidates. The H5
modifications can be expressed from DNA or adenoviral vectors, or the
proteins themselves can be administered. Additionally, these mutated
HAs can be used to develop therapeutic monoclonal antibodies. The
technology describes three (3) unique monoclonal antibodies that react
with wild-type H5, wild-type H5 and mutant HA equivalently, and the
mutant HA, respectively.
Applications: Prophylactic influenza vaccine; Therapeutic
antibodies.
Inventors: Gary J. Nabel et al. (VRC/NIAID).
Patent Status: U.S. Patent Application No. 60/850,761 filed 10 Oct
2006 (HHS Reference No. E-306-2006/0-US-01).
U.S. Patent Application No. 60/860,301 filed 20 Nov 2006 (HHS
Reference No. E-306-2006/1-US-01).
U.S. Patent Application No. 60/920,874 filed 30 Mar 2007 (HHS
Reference No. E-306-2006/2-US-01).
U.S. Patent Application No. 60/921,669 filed 02 Apr 2007 (HHS
Reference No. E-306-2006/3-US-01).
Development Status: Animal (mouse) data available.
Licensing Status: Available for licensing.
Licensing Contact: Susan Ano, Ph.D.; 301/435-5515;
anos@mail.nih.gov.
Antiviral Compounds With Broad Neutralization Capabilities
Description of Technology: The NIH is pleased to announce as
available for licensing a technology that provides for novel antiviral
compounds effective against a broad spectrum of viruses. The compounds
utilize soluble phospholipases, exemplified by PLA2-X and
others, either alone or as a fusion protein with a viral binding
polypeptide. These compositions are able to inactivate viruses through
enzymatic degradation of the viral membrane without affecting target
cells
[[Page 46642]]
of infection. The potential broad application of these compounds could
address a significant health need for effective antivirals.
Applications: This technology provides compositions and methods for
the treatment of viral infection and has human and veterinary
applications.
Advantages: The compounds described by the current technology are
not necessarily specific for a type of virus or viral strain like many
currently available antiviral compounds, and therefore have broad
therapeutic antiviral applications. Further, virions resistant to
damage by antibody and complement have been shown to be lysed by
compounds of the invention suggesting antiviral surveillance
independent of a humoral immune response.
Development Status: Proof of concept in vitro studies using human
cells have shown antiviral activity with viruses pseudotyped with
envelope proteins from Ebola, HIV, Marburg and MoMuLV.
Inventors: Gary Nabel and Jae-Ouk Kim (VRC/NIAID).
Publication: J-O Kim et al. Lysis of human immunodeficiency virus
type 1 by a specific secreted human phospholipase A2. J
Virol. 2007 Feb;81(3):1444-1450.
Patent Status: PCT Application No. PCT/US2007/004471 filed 21 Feb
2007 (HHS Reference No. E-013-2006/1-PCT-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Susan Ano, Ph.D.; 301/435-5515;
AnoS@mail.nih.gov
Design of Multi-Functional RNA Nanoparticles and Nanotubes
Description of Invention: The characteristic function of
nanoparticles is their ability to deliver drug across biological
barriers to the target site while protecting the drugs from the
biological environment until they reach the target site. The present
invention provides polyvalent RNA nanostructures comprising RNA I
inverse (RNA Ii) or RNA II inverse (RNA IIi) like motifs that have
multiple positions available for conjugation of therapeutic, diagnostic
or delivery agents. The nanoparticles of the invention do not induce
significant immune response by themselves and are smaller than
currently available nanoparticles and therefore allow for increased
efficiency of administration. The nanoparticles of this invention have
the ability to deliver one or more different therapeutic agents in a
single particle. Further, the RNA nanoparticles are also capable of
self-assembly into nanotubes of various shapes which offer potentially
broad uses in medical implants, gene therapy, nanocircuits, scaffolds
and medical testing.
Applications:
1. Use as diagnostic tool.
2. Use as drug delivery composition to treat various diseases or
conditions.
3. Use in screening or identifying potential chemotherapeutic
agents.
4. Use in riboswitch aptamers, ribozymes or beacons.
5. Use in nanocircuits, medical implants, gene therapy, scaffolds
and medical testing.
Market: Broad application in various fields, such as therapeutics,
drug delivery, diagnostics, provides a wide market potential.
Development Status: Early stage.
Inventors: Bruce A. Shapiro and Yaroslava G. Yingling (NCI).
Publication: YG Yingling and BA Shapiro. Computational Design of an
RNA Hexagonal Nanoring and an RNA Nanotube. Nano Lett. 2007 Jul 6. Epub
ahead of print,.doi 10.1021/nl070984r.
Patent Status: U.S. Provisional Application No. 60/810,283 filed 02
Jun 2006 (HHS Reference No. E-233-2006/0-US-01).
U.S. Provisional Application No. 60/918,181 filed 14 Mar 2007 (HHS
Reference No. E-233-2006/1-US-01).
Licensing Status: Available for exclusive and non-exclusive
licensing.
Licensing Contact: Robert M. Joynes J.D., M.S.; 301/594-6565;
joynesr@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute's
Nanobiology Program (https://www-lecb.ncifcrf.gov/bshapiro/)
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize RNA nanostructures. Please contact John D. Hewes, Ph.D.
at 301-435-3121 or hewesj@mail.nih.gov for more information.
Methods for Preparing Complex Multivalent Immunogenic Conjugates
Description of Technology: Claimed in this application are novel
methods for preparing complex multivalent immunogenic conjugates and
conjugate vaccines. The multivalent conjugates and conjugate vaccines
are synthesized by conjugating mixtures of more than one polysaccharide
at a desired ratio of the component polysaccharides to at least one
carrier protein using hydrazide chemistry. Because of the high
efficiency of hydrazide chemistry in conjugation, the polysaccharides
are effectively conjugated to the carrier protein(s) so that the
resulting complex synthesized vaccine conjugate products, without
requiring tedious and complicated purification procedures such as
chromatography and/or ammonium sulfate precipitation, are efficacious
in inducing antibodies in mice against each component polysaccharide.
The methods claimed in this application simplify the preparation of
multivalent conjugate vaccines by utilizing simultaneous conjugation
reactions in a single reaction mixture or batch that includes at least
two immunogenic-distinct polysaccharides. This single-batch
simultaneous reaction eliminates the need for multiple parallel
synthesis processes for each polysaccharide vaccine conjugate component
as employed in conventional methods for making multivalent conjugate
vaccines.
Application: Cost effective and efficient manufacturing of
conjugate vaccines.
Inventors: Che-Hung Robert Lee (CBER/FDA).
Patent Status: PCT Application No. PCT/US2007/006627 filed 16 Mar
2007 (HHS Reference No. E-085-2005/0-PCT-02).
Licensing Status: Available for exclusive or non-exclusive
licensing. The technology is not available for licensing in the field
of use of multivalent meningitis vaccines.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Dated: August 13, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-16400 Filed 8-20-07; 8:45 am]
BILLING CODE 4140-01-P
