Government-Owned Inventions; Availability for Licensing, 54346-54347 [2010-22182]
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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
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.
SUMMARY:
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Vortex Counter-Current
Chromatography (CCC) System
Description of Invention: Available for
licensing and commercial development
is a vortex counter-current
chromatography system. The system has
a rotary frame engaged to a vortex
separation column for rotation in one
direction through a vortex separation
shaft engaged to a pulley system. The
rotary frame is engaged to a central shaft
that rotates the rotary frame in a
direction opposite that of the vortex
separation column such that planetary
motion is imparted to the vortex
separation column. The vortex
separation column may be configured to
receive a solvent system separable
between two immiscible liquid phases
introduced into the vortex separation
column. A pulley system is operatively
engaged to the separation column shaft
and the central shaft for rotating the
separation column shaft and the cortex
separation column in a synchronous
rotational direction opposite to the
rotational direction of the rotary frame
for imparting a type-I planetary motion
to the vortex separation column. A
counter-weight column is engaged at a
symmetrical position opposite the
vortex separation column along the
VerDate Mar<15>2010
15:24 Sep 03, 2010
Jkt 220001
rotary frame, wherein the two
immiscible liquid phases undergo a
vortex motion during rotation of the
vortex separation column such that
mixing of the two immiscible liquid
phases takes place with a plane
perpendicular to an axis of the vortex
separation column.
Compared with conventional CCC
systems, the vortex system has much
higher partition efficiency in terms of
height equivalent to a theoretical plate
(only 2 cm compared with 20 cm that
is required for the conventional system).
The vortex system also provides an
advantage of low column pressure
which facilitates application of a large
industrial-scale separation without a
risk of leakage of solvent and column
damage caused by high pressure.
Applications
• Drug Discovery.
• Chromatography.
• Natural Products Research.
Inventors: Yoichiro Ito (NHLBI).
Publications
1. Ito Y, Bowman RL. Countercurrent
chromatography with flow-through coil
planet centrifuge. Science
1971;173:420–422. [PubMed: 5557320]
2. Ito Y, Bowman RL. Countercurrent
chromatography with flow-through coil
planet centrifuge. J Chromatogr Sci.
1973;11:284–291.
Patent Status: U.S. Provisional
Application No. 61/368,157 filed 27 Jul
2010 (HHS Reference No. E–196–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Superresolution Microscopy via Azicon
Beam Polarization Devices
Description of Invention: The
technology offered for licensing pertains
to novel polarizers that produce
tangentially and radially polarized
beams. The polarizers and polarizing
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
beam splitter of the technology include
one or more pairs of axicons (also
known as conical lenses) that are
configured to separate an input beam
into a radially polarized component and
a tangentially (or azimuthally) polarized
component. A second axicon pair can be
positioned to recombine the tangentially
polarized component so as to provide a
more uniform beam intensity. The radial
polarized component can be reflected or
otherwise directed so that one or both
the radial and tangential components
are available for use.
Applications
The disclosed methods and apparatus
of the technology can be used to provide
radially or tangentially polarized beams
(or both) to many applications. In
particular, the technology can be
effectively utilized in applications such
as:
• Multi-photon microscopy.
• Microlithography.
• Ultrafine imaging in conjunction
with the use of fluorophores.
Advantages: The technology provides
higher optical resolution for certain
applications as compared with currently
used methodologies.
Development Status: The invention is
fully developed.
Inventors: Jay R. Knutson (NHLBI).
Patent Status: U.S. Provisional
Application No. 61/308,202 filed 25 Feb
2010 (HHS Reference No. E–251–2009/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contacts
• Uri Reichman, Ph.D., MBA; 301–
435–4616; UR7a@nih.gov.
• Michael Shmilovich, Esq.; 301–
435–5019; shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The NHLBI Laboratory of Molecular
Biophysics is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact Brian Bailey at 301–594–4094
for more information.
Mucosal Cytotoxic T Lymphocyte
Responses
Description of Invention: The
invention offered for licensing provides
methods and compositions for
induction of an antigen-specific,
mucosal cytotoxic T lymphocyte (CTL)
response useful in preventing and
treating infections with pathogens that
gain entry via a mucosal surface. The
methods of the invention involve
administering either a soluble antigen
itself, or a polynucleotide encoding the
E:\FR\FM\07SEN1.SGM
07SEN1
EN07SE10.000</GPH>
54346
Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
soluble antigen, to a mucosal surface.
The soluble antigens can be full length,
naturally occurring polypeptides or
fragments (i.e. peptides) derived from
them. The soluble antigen is
administered with an adjuvant at the
mucosal site or without an adjuvant.
Adjuvants can be, for example, Cholera
toxin (CT), mutant CT (MCT), E. coli
heat labile enterotoxin (LT) and others.
Cytokines like IL–12 or IFNg can also be
administered to enhance the
immunoreactivity. Mucosal routes of
administration include intrarectal (IR),
intranasal (IN), intragastric (IG),
intravaginal (IVG) or intratratracheal
(IT). Soluble antigens can be derived
from pathogenic viruses (e.g. HIV,
influenza, or hepatitis virus), bacteria
(e.g. Listeria monocytogenes), or
prozoans. Furthermore, the soluble
antigen can be tumor-associated antigen
for cancer applications.
The utility of the technology has been
extensively demonstrated when applied
to HIV. Details about the HIV studies are
provided in the eight (8) publications
cited below.
Applications
• Immunization to treat infectious
diseases.
• Possible applications in cancer
therapy.
Development Status: Proof of concept
has been demonstrated, in particular as
related to HIV.
Inventors: Jay A. Berzofsky (NCI) et al.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Relevant Publications
1. Belyakov IM, Derby MA, Ahlers JD,
Kelsall BL, Earl P, Moss B, Strober W,
Berzofsky JA. Mucosal immunization
with HIV–1 peptide vaccine induces
mucosal and systemic cytotoxic T
lymphocytes and protective immunity
in mice against intrarectal recombinant
HIV-vaccinia challenge. Proc Natl Acad
Sci USA. 1998 Feb 17;95(4):1709–1714.
[PubMed: 9465081]
2. Belyakov IM, Ahlers, JD,
Brandwein BY, Earl P, Kelsall B, Moss
B, Strober W, Berzofsky JA. The
importance of local mucosal HIVspecific CD8+ cytotoxic T lymphocytes
for resistance to mucosal viral
transmission in mice and enhancement
of resistance by local administration of
IL–12. J Clin Invest. 1998 Dec
15;102(12):2072–2081. [PubMed:
9854042]
3. Belyakov IM, Ahlers JD, Clements
JD, Strober W, Berzofsky JA. Interplay of
cytokines and adjuvants in the
regulation of mucosal and systemic HIVspecific CTL. J Immunol. 2000 Dec
1;165(11):6454–6462. [PubMed:
11086085]
VerDate Mar<15>2010
15:24 Sep 03, 2010
Jkt 220001
4. Belyakov IM, Hel Z, Kelsall B,
Kuznetsov VA, Ahlers JD, Nacsa J,
Watkins DI, Allen TM, Sette A, Altman
J, Woodward R, Markham PD, Clements
JD, Franchini G, Strober W, Berzofsky
JA. Mucosal AIDS vaccine reduces
disease and viral load in gut reservoir
and blood after mucosal infection of
macaques. Nat Med. 2001
Dec;7(12):1320–1326. [PubMed:
11726972]
5. Belyakov IM, Kuznetsov VA,
Kelsall B, Klinman D, Moniuszko M,
Lemon M, Markham PD, Pal R,
Clements JD, Lewis MG, Strober W,
Franchini G, Berzofsky JA. Impact of
vaccine-induced mucosal high avidity
CD8+ CTLs in delay of AIDS-viral
dissemination from mucosa. Blood 2006
Apr 15;107(8):3258–3264. [PubMed:
16373659]
6. Belyakov IM, Isakov DV, Zhu Q,
Dzutsev A, Berzofsky JA. A novel
functional CTL avidity/activity
compartmentalization to the site of
mucosal immunization contributes to
protection of macaques against simian/
human immunodeficiency viral
depletion of mucosal CD4+ T cells. J
Immunol. 2007 Jun 1;178(11):7211–
7221. [PubMed: 17513770]
7. Belyakov IM, Ahlers JD, Nabel GJ,
Moss B, Berzofsky JA. Generation of
functionally active HIV–1 specific CD8+
CTL in intestinal mucosa following
mucosal, systemic, or mixed primeboost immunization. Virology 2008 Nov
10;381(1):106–115. [PubMed: 18793787]
8. Sui Y, Zhu Q, Gagnon S, Dzutsev
A, Terabe M, Vaccari M, Venzon D,
Klinman D, Strober W, Kelsall B,
Franchini G, Belyakov IM, Berzofsky JA.
Innate and adaptive immune correlates
of vaccine and adjuvant-induced control
of mucosal transmission of SIV in
macaques. Proc Natl Acad Sci USA.
2010 May 25;107(21):9843–9848.
[PubMed: 20457926]
Patent Status: HHS Reference No. E–
268–1997/2—
• U.S. Patent Application No. 09/
508,552, which issued as U.S. Patent
No. 6,749,856 on 15 Jun 2004.
• Foreign patents issued in Australia
(Application Number 93862/98 and
Patent Number 757310) and in
European countries (Application
Number 98946965.5 and Patent Number
1011720): Germany, France, Ireland,
United Kingdom, Italy, Portugal and
Spain.
• Divisional U.S. Patent Application
No. 10/815,340 filed 30 Mar 2004.
Licensing Status: Available for
licensing and commercial development.
Licensing Contacts: Uri Reichman,
PhD, MBA; 301–435–4616;
UR7a@nih.gov; or John Stansberry, PhD;
301–435–5236; js852e@nih.gov.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
54347
Collaborative Research Opportunity:
The Center for Cancer Research, Vaccine
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Mucosal Cytotoxic T
Lymphocyte Responses. Please contact
John D. Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: August 31, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–22182 Filed 9–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0426]
Draft Guidance for Industry: Bar Code
Label Requirements—Questions and
Answers (Question 12 Update);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Bar Code Label
Requirements—Questions and Answers
(Question 12 Update)’’ dated August
2010. This draft guidance provides you,
manufacturers of a licensed vaccine,
with advice concerning compliance
with the bar code label requirements. In
this guidance, FDA is proposing to
amend our response to question 12
(Q12) in the ‘‘Bar Code Label
Requirements—Questions and Answers’’
guidance dated October 2006 (Bar Code
Guidance), to provide recommendations
to manufacturers of licensed vaccines in
connection with the use of alternative
coding technologies. When this
guidance is finalized, we intend to
incorporate the revised response to Q12
into the Bar Code Guidance, but
otherwise continue with our
recommendations for bar code label
requirements as currently provided in
the Bar Code Guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
SUMMARY:
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54346-54347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22182]
[[Page 54346]]
-----------------------------------------------------------------------
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.
Vortex Counter-Current Chromatography (CCC) System
Description of Invention: Available for licensing and commercial
development is a vortex counter-current chromatography system. The
system has a rotary frame engaged to a vortex separation column for
rotation in one direction through a vortex separation shaft engaged to
a pulley system. The rotary frame is engaged to a central shaft that
rotates the rotary frame in a direction opposite that of the vortex
separation column such that planetary motion is imparted to the vortex
separation column. The vortex separation column may be configured to
receive a solvent system separable between two immiscible liquid phases
introduced into the vortex separation column. A pulley system is
operatively engaged to the separation column shaft and the central
shaft for rotating the separation column shaft and the cortex
separation column in a synchronous rotational direction opposite to the
rotational direction of the rotary frame for imparting a type-I
planetary motion to the vortex separation column. A counter-weight
column is engaged at a symmetrical position opposite the vortex
separation column along the rotary frame, wherein the two immiscible
liquid phases undergo a vortex motion during rotation of the vortex
separation column such that mixing of the two immiscible liquid phases
takes place with a plane perpendicular to an axis of the vortex
separation column.
Compared with conventional CCC systems, the vortex system has much
higher partition efficiency in terms of height equivalent to a
theoretical plate (only 2 cm compared with 20 cm that is required for
the conventional system). The vortex system also provides an advantage
of low column pressure which facilitates application of a large
industrial-scale separation without a risk of leakage of solvent and
column damage caused by high pressure.
[GRAPHIC] [TIFF OMITTED] TN07SE10.000
Applications
Drug Discovery.
Chromatography.
Natural Products Research.
Inventors: Yoichiro Ito (NHLBI).
Publications
1. Ito Y, Bowman RL. Countercurrent chromatography with flow-
through coil planet centrifuge. Science 1971;173:420-422. [PubMed:
5557320]
2. Ito Y, Bowman RL. Countercurrent chromatography with flow-
through coil planet centrifuge. J Chromatogr Sci. 1973;11:284-291.
Patent Status: U.S. Provisional Application No. 61/368,157 filed 27
Jul 2010 (HHS Reference No. E-196-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Superresolution Microscopy via Azicon Beam Polarization Devices
Description of Invention: The technology offered for licensing
pertains to novel polarizers that produce tangentially and radially
polarized beams. The polarizers and polarizing beam splitter of the
technology include one or more pairs of axicons (also known as conical
lenses) that are configured to separate an input beam into a radially
polarized component and a tangentially (or azimuthally) polarized
component. A second axicon pair can be positioned to recombine the
tangentially polarized component so as to provide a more uniform beam
intensity. The radial polarized component can be reflected or otherwise
directed so that one or both the radial and tangential components are
available for use.
Applications
The disclosed methods and apparatus of the technology can be used
to provide radially or tangentially polarized beams (or both) to many
applications. In particular, the technology can be effectively utilized
in applications such as:
Multi-photon microscopy.
Microlithography.
Ultrafine imaging in conjunction with the use of
fluorophores.
Advantages: The technology provides higher optical resolution for
certain applications as compared with currently used methodologies.
Development Status: The invention is fully developed.
Inventors: Jay R. Knutson (NHLBI).
Patent Status: U.S. Provisional Application No. 61/308,202 filed 25
Feb 2010 (HHS Reference No. E-251-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contacts
Uri Reichman, Ph.D., MBA; 301-435-4616; UR7a@nih.gov.
Michael Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The NHLBI Laboratory of
Molecular Biophysics is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize this technology. Please contact Brian Bailey
at 301-594-4094 for more information.
Mucosal Cytotoxic T Lymphocyte Responses
Description of Invention: The invention offered for licensing
provides methods and compositions for induction of an antigen-specific,
mucosal cytotoxic T lymphocyte (CTL) response useful in preventing and
treating infections with pathogens that gain entry via a mucosal
surface. The methods of the invention involve administering either a
soluble antigen itself, or a polynucleotide encoding the
[[Page 54347]]
soluble antigen, to a mucosal surface. The soluble antigens can be full
length, naturally occurring polypeptides or fragments (i.e. peptides)
derived from them. The soluble antigen is administered with an adjuvant
at the mucosal site or without an adjuvant. Adjuvants can be, for
example, Cholera toxin (CT), mutant CT (MCT), E. coli heat labile
enterotoxin (LT) and others. Cytokines like IL-12 or IFN[gamma] can
also be administered to enhance the immunoreactivity. Mucosal routes of
administration include intrarectal (IR), intranasal (IN), intragastric
(IG), intravaginal (IVG) or intratratracheal (IT). Soluble antigens can
be derived from pathogenic viruses (e.g. HIV, influenza, or hepatitis
virus), bacteria (e.g. Listeria monocytogenes), or prozoans.
Furthermore, the soluble antigen can be tumor-associated antigen for
cancer applications.
The utility of the technology has been extensively demonstrated
when applied to HIV. Details about the HIV studies are provided in the
eight (8) publications cited below.
Applications
Immunization to treat infectious diseases.
Possible applications in cancer therapy.
Development Status: Proof of concept has been demonstrated, in
particular as related to HIV.
Inventors: Jay A. Berzofsky (NCI) et al.
Relevant Publications
1. Belyakov IM, Derby MA, Ahlers JD, Kelsall BL, Earl P, Moss B,
Strober W, Berzofsky JA. Mucosal immunization with HIV-1 peptide
vaccine induces mucosal and systemic cytotoxic T lymphocytes and
protective immunity in mice against intrarectal recombinant HIV-
vaccinia challenge. Proc Natl Acad Sci USA. 1998 Feb 17;95(4):1709-
1714. [PubMed: 9465081]
2. Belyakov IM, Ahlers, JD, Brandwein BY, Earl P, Kelsall B, Moss
B, Strober W, Berzofsky JA. The importance of local mucosal HIV-
specific CD8+ cytotoxic T lymphocytes for resistance to mucosal viral
transmission in mice and enhancement of resistance by local
administration of IL-12. J Clin Invest. 1998 Dec 15;102(12):2072-2081.
[PubMed: 9854042]
3. Belyakov IM, Ahlers JD, Clements JD, Strober W, Berzofsky JA.
Interplay of cytokines and adjuvants in the regulation of mucosal and
systemic HIV-specific CTL. J Immunol. 2000 Dec 1;165(11):6454-6462.
[PubMed: 11086085]
4. Belyakov IM, Hel Z, Kelsall B, Kuznetsov VA, Ahlers JD, Nacsa J,
Watkins DI, Allen TM, Sette A, Altman J, Woodward R, Markham PD,
Clements JD, Franchini G, Strober W, Berzofsky JA. Mucosal AIDS vaccine
reduces disease and viral load in gut reservoir and blood after mucosal
infection of macaques. Nat Med. 2001 Dec;7(12):1320-1326. [PubMed:
11726972]
5. Belyakov IM, Kuznetsov VA, Kelsall B, Klinman D, Moniuszko M,
Lemon M, Markham PD, Pal R, Clements JD, Lewis MG, Strober W, Franchini
G, Berzofsky JA. Impact of vaccine-induced mucosal high avidity CD8+
CTLs in delay of AIDS-viral dissemination from mucosa. Blood 2006 Apr
15;107(8):3258-3264. [PubMed: 16373659]
6. Belyakov IM, Isakov DV, Zhu Q, Dzutsev A, Berzofsky JA. A novel
functional CTL avidity/activity compartmentalization to the site of
mucosal immunization contributes to protection of macaques against
simian/human immunodeficiency viral depletion of mucosal CD4+ T cells.
J Immunol. 2007 Jun 1;178(11):7211-7221. [PubMed: 17513770]
7. Belyakov IM, Ahlers JD, Nabel GJ, Moss B, Berzofsky JA.
Generation of functionally active HIV-1 specific CD8+ CTL in intestinal
mucosa following mucosal, systemic, or mixed prime-boost immunization.
Virology 2008 Nov 10;381(1):106-115. [PubMed: 18793787]
8. Sui Y, Zhu Q, Gagnon S, Dzutsev A, Terabe M, Vaccari M, Venzon
D, Klinman D, Strober W, Kelsall B, Franchini G, Belyakov IM, Berzofsky
JA. Innate and adaptive immune correlates of vaccine and adjuvant-
induced control of mucosal transmission of SIV in macaques. Proc Natl
Acad Sci USA. 2010 May 25;107(21):9843-9848. [PubMed: 20457926]
Patent Status: HHS Reference No. E-268-1997/2--
U.S. Patent Application No. 09/508,552, which issued as
U.S. Patent No. 6,749,856 on 15 Jun 2004.
Foreign patents issued in Australia (Application Number
93862/98 and Patent Number 757310) and in European countries
(Application Number 98946965.5 and Patent Number 1011720): Germany,
France, Ireland, United Kingdom, Italy, Portugal and Spain.
Divisional U.S. Patent Application No. 10/815,340 filed 30
Mar 2004.
Licensing Status: Available for licensing and commercial
development.
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 Center for Cancer Research,
Vaccine Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize Mucosal Cytotoxic T Lymphocyte Responses.
Please contact John D. Hewes, PhD at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Dated: August 31, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-22182 Filed 9-3-10; 8:45 am]
BILLING CODE 4140-01-P
