[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54346-54347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22182]



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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.

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; 
[email protected].

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; [email protected].
     Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].
    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; 
[email protected]; or John Stansberry, PhD; 301-435-5236; [email protected].
    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 
[email protected] 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