[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59261-59262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22151]


-----------------------------------------------------------------------

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.

Chromatography Apparatus and Method

Yoichiro Ito (NHLBI)
U.S. Provisional Application Filed 24 Aug 2004 (DHHS Reference No. E-
277-2004/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing for industrial scale-up production and 
commercial distribution is an improved countercurrent chromatography 
apparatus comprising a disk having a series of interconnected and 
elongated compartments coupled by ducts that form a portion of a groove 
in a surface of the disk. At least some of the elongated compartments 
have an aspect ratio of at least greater than two and a width greater 
than twice the width of the connecting ducts and a length of about 10 
to 20 times the length of the connecting ducts. This apparatus may also 
be used for a large-scale industrial separation by coaxially rotating 
in centrifugal or gravitational fields.
[GRAPHIC] [TIFF OMITTED] TN04OC04.040

HIV-1 Infection Detection Assay for Seroconverted HIV-1 Vaccine 
Recipients

Hana Golding, Surender Khurana (FDA/CBER)
U.S. Provisional Application Filed 08 Sep 2004 (DHHS Reference No. E-
259-2004/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing and commercial distribution is an assay 
method and kit having diagnostic peptide fragments derived from human 
immunodeficiency virus-1 (HIV-1). The new serology assay includes HIV-1 
peptide fragments epitopes that map to HIV-1 GAG-p6, and gp41 genes. 
These epitopes are broadly reactive with early sera from HIV infected 
individuals, do not illicit protective antibodies, do not illicit 
immunologic cytotoxicity and are readily removable from current and 
future HIV-1 candidates. The assay is advantageous in detecting HIV-1 
early breakthrough infections in seroconverted vaccine recipients while 
being able to distinguish between individuals with bonafide 
breakthrough infections versus non-HIV infected vaccine recipients 
presenting only vaccine borne antibodies. For example, 90% of vaccine 
recipients receiving a Canarypox construct expressing a plurality of 
HIV antigens (Env, Gag, Pol, HIV Protease, Nef) followed by an envelope 
protein boost, scored positive in FDA licensed enzyme immunoassay, 
rapid test, and Western blot (Marta-Louise Ackers et al., J Infect Dis. 
187:879 (2003)). Such seroconversion has a negative impact on phase III 
efficacy trials of prophylactic HIV vaccines that require early 
detection of breakthrough infections and also exclude non-HIV infected 
vaccine recipients from the pool of potential blood donors.

Flow-Through, Thermal-Expansion-Compensated Microcells for Analytical 
Transmission Infrared and Other Light Spectroscopies

Edward Mertz (NICHD), James Sullivan (ORS)

[[Page 59262]]

U.S. Patent Application No. 10/926,405 Filed 26 Aug 2004 (DHHS 
Reference No. E-096-2004/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing and commercial distribution are optical 
cells that are spectroscopically, thermally and mechanically stable and 
can be used for spectroscopic measurement in transmission, reflection, 
transmission-reflection, emission, or scattering modes without 
modification of standard spectrometers. The cell handles liquid samples 
and biological or solid samples equilibrated with bathing fluid which 
does not interfere with the light beam, allows liquid sample or bathing 
fluid to be exchanged without cell reassembly, requires only a small 
amount of sample (down to 0.1[mu]l), allows for different sample gaps 
(0.2-1000[mu]m) to be easily and inexpensively set, and allows spectral 
measurements to be taken over wavelengths ranging at least from the 
mid-infrared to the vacuum ultraviolet. The inventive cell and methods 
allows sensitive and reproducible monitoring spectra and their changes 
(down to at least 10-4 absorbance units) caused by changes 
in temperature or in composition of bathing fluid or by fast kinetic 
processes.
    This research is described, in part, in Mertz E.L., Leikin S. 
``Interactions of Inorganic Phosphate and Sulfate Anions with 
Collagen'', Biochemistry, in press.

Device for Sequential Protein Transfer From a Gel

Jozsef Antal, Zsuzsanna Buzas, Andreas Chrambach (NICHD)
DHHS Reference No. E-346-2003/0-US-01 filed 09 July 2004
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing and commercialization is a device for 
sequentially eluting proteins and peptides. The device comprises a 
separation medium having an outlet, and a collector having a first 
receptacle and second receptacle that can be sequentially brought into 
contact with the outlet of the separation medium by translating 
(rotating) the first receptacle and the second receptacle in relation 
to the outlet of the separation medium. The invention is adaptable to 
capillary electrophoresis as well. Multiple sequential protein transfer 
from SDS-PAGE gel to a mass spectrometer is made possible. Separated 
protein bands sequentially electrophorese into low melting agarose 
plugs distributed along the surface of a plastic drum. The effective 
electroelution of a protein from a gel band to an agarose filled slot. 
The drum is rotated to receive each band individually. Migrating SDS 
linearized proteins are electrophoresed into the receptacle slot drum. 
The drum is rolled until each protein of interest is separated. Agarose 
plugs are lifted from the drum slots; enzymatically dissolved, and 
loaded directly onto a MALDI spectrometer. Between two agarose layers, 
gel free collection chambers can be formed inside the drum providing 
solution phase fraction collection.
[GRAPHIC] [TIFF OMITTED] TN04OC04.041

    This research is described in: Buzas Z, Antal J, Gilligan JJ, 
Backlund PS, Yergey AL, Chrambach A. An electroelution apparatus for 
sequential transfer of sodium dodecyl sulfate-proteins into agarose and 
mass spectrometric identification of Li-Na-dodecyl sulfate-proteins 
from solubilized agarose. Electrophoresis. 2004 Apr;25(7-8):966-9.

Simultaneous HDL/LDL/Total Lipoprotein Single Tube Homogeneous Assay

Alan T. Remaley, Maureen Sampson, Gyorgy Csako (CC)
DHHS Reference No. E-090-1999: U.S. Patent App. 09/980,751 Filed 01 Nov 
2001; European Patent App. Ser. No. 00939404.0 Filed 26 May 2000; 
Canadian Patent. App. 2375210 Filed 26 May 2000; Australian Pat. App. 
54493/00 filed 26 May 2000; Japanese Patent App. 2001-500866 filed 26 
May 2000
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing is an invention in which a single tube 
assay is used for determining high-density lipoprotein HDL-cholesterol 
(HDL-C), low density lipoprotein (LDL-C) and total cholesterol (total-
C), from a single serum sample. This assay is an efficient tool for use 
in determining patient risk factors for heart disease. Previously, 
multiple costly tests were performed in order to determine low-density 
lipoprotein LDL-C and HDL-C by measuring total-C, total triglyceride, 
and HDL-C. That method of testing had limitations and was complex. 
Using this methodology, the homogeneous assay for HDL-C does not 
require physically separating HDL. The new assay developed is 
efficient, less costly, and compares favorably to current assays for 
HDL-C, total cholesterol, and triglyceride. This technology may also be 
used to simplify the procedure for the point of care testing of 
hyperlipidemia.

    Dated: September 22, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-22151 Filed 10-1-04; 8:45 am]
BILLING CODE 4140-01-P