[Federal Register Volume 71, Number 107 (Monday, June 5, 2006)]
[Notices]
[Pages 32357-32364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5105]


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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.

Multiplex Microarray for Simultaneous Detection of Hepatitis C Virus, 
Hepatitis B Virus, and Human Immunodeficiency Virus Type-1

    Description of Technology: Available for licensing and commercial 
development are patent rights that cover a specific and sensitive 
microarray (TTD-V-1) and multiplex assay for the simultaneous detection 
and discrimination of Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) 
and Human Immunodeficiency Virus Type-1 (HIV-1), which include both RNA 
and DNA genomes. Four specific probes (30-45 bp oligonucleotides) for 
each of these three viruses as well as the two internal controls were 
designed. Totally, each microarray consists of 20 probes immobilized on 
silylated glass slides. The single-stranded Cy5-labeled samples for 
microarray hybridization were obtained from labeling the amplicons 
using primer extension thermocycling. The multiplex microarray assay 
was able to detect and discriminate as low as 3 copies of genotypes A, 
B, C, D, and 10 copies of genotype E of HBV, 10 copies of HCV (genotype 
1b), and 20 copies of HIV-1 (group M, subtype B) in a single multiplex 
reaction. The microarray assay could also detect the coexistence of two 
or three of these viruses and discriminate them simultaneously. The 
results of this study demonstrated the feasibility and performance of 
microarray-based multiplex detection of the three viruses, HCV, HBV, 
and HIV-1 in comparison with conventional individual PCR and gel 
electrophoresis technique.
    Inventors: Chu Chieh Xia, Gerardo Kaplan, Hira Nakhasi, Amy Yang, 
Raj Puri (FDA).
    Patent Status: U.S. Provisional Application No. 60/759,214 filed 
January 17, 2006 (HHS Reference No. E-077-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.

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    Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected].
    Collaborative Research Opportunity: The Food and Drug 
Administration's Center for Biologics Evaluation and Research (CBER) is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this technology. Please contact Beatrice Droke, Technology Development 
Coordinator, FDA, (301) 827-7008 for more information.

Ear Hole Cutter for Animal Identification and Tissue Sampling

    Description of Technology: This invention provides a better way of 
identification and tissue sampling for lab animals. Current systems 
rely on a technology that was never meant for biological use, namely 
the technology of paper punches. Such punches punch a hole through a 
mouse's ear with predictable consequences: ``hanging chads'' of tissue 
that must be excised with scissors, wasting time and further 
traumatizing the mouse's delicate physiology. Equally inefficient, the 
technician must pick up the tissue with a forceps to put it in a tube, 
if DNA typing is needed.
    In contrast, a new device designed by a veterinarian and his 
collaborators allows rapid and painless punching/sampling. It cuts, 
rather than punches, holes of various diameters through animal ears. 
This thumb-powered cutter utilizes stainless steel hypo-tubing (like a 
hypodermic needle, but without the sharp point) to make holes. Instead 
of pressing with all of one's might to punch a hole, just a light press 
on the spring-loaded shaft is sufficient to quickly and nearly-
painlessly cut a perfectly round hole through an ear. A tube can be 
loaded underneath the hypo-tubing to catch the tissue plug for 
genotyping of each animal.
    A prototype of the apparatus is currently available (see figure 
below). Although designed for mice, the device can be scaled for use 
with other rodents, pigs, cows, rabbits, sheep or other animals.

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    Inventors: Brandon P. Reines (NIAID), Andriy Morgun (NIAID), 
Natalia Shulzhenko (NIAID), Franklin Sharpnack (ORS), Howard E. Metger 
(ORS), Jimmie Powell (ORS).
    Patent Status: U.S. Provisional Application No. 60/783,209 filed 
March 16, 2006 (HHS Reference No. E-012-2006/0-US-01).
    Licensing Contact: Michael A. Shmilovich. Esq.; 301/435-5019; 
[email protected].

System and Methods for Detecting and Characterizing Macromolecular 
Interactions in Solution

    Description of Technology: The present invention relates to systems 
and methods for sensitive detection and characterization of 
macromolecular interactions in homogenous or heterogeneous solutions of 
biological and/or synthetic macromolecules. The disclosed method of 
detection does not require labeling or chemical modification of any 
test substance, and it is as rapid or more rapid than presently 
available methods. The system includes a dispenser to dispense a 
solution containing one or more macromolecular solute components whose 
concentrations vary with time in a controlled fashion, and two 
detectors to measure, respectively, the time-dependent static light 
scattering and composition of the dispensed solution. The composition 
of solution may be determined from measurements of either UV-visible 
absorbance or differential refractive index. The light scattering and 
composition detectors are installed in parallel, so that at any given 
time point, both detectors collect data from elements of solution of 
identical composition. High resolution information about the 
stoichiometry and strength of macromolecular interactions is 
subsequently obtained by quantitative analysis of the composition 
dependence of static light scattering. This invention could provide a 
valuable tool for high-throughput proteomics research.
    Inventors: Allen P. Minton et al. (NIDDK).
    Patent Status: U.S. Provisional Application No. 60/703,814 filed 
July 28, 2005 (HHS Reference No. E-167-2005/0-US-01).
    Licensing Contact: Chekesha Clingman, Ph.D.; 301/435-5018; 
[email protected].

Ultrasonic Waves With Nanovessels or Tethered Nanotube/Monoclonal 
Antibody Composites for Cancer Therapy

    Description of Technology: Available for licensing and commercial 
development are compositions and their methods of use for delivering 
therapeutic agents transported on or inside nanostructures to target 
sites for cancer therapy. Ultrasonic waves are aimed at the therapeutic 
site and tuned to open nanostructures delivered to the site. 
Alternately, nanostructures violently exploding by ultrasound may not 
need to contain additional specific therapeutic agents in order to 
destroy cells in close proximity to the blast. Therapeutic site-
specific cloned antibodies (immunoglobulin (IgG)) or other immunity-
based biomolecules are used to carry nanotubes (single wall 
nanovessels). These are covalently bound to the IgGs, to the sites of 
interest.
    Ultrasound waves with a frequency absorbed by the nanotubes (about 
20-40 KHz), are used to explode the carbon nanotubes in proximity to 
the tumor. The concept of using ultrasound waves to explode carbon 
nanotubes is analogous to the ultrasonic method that is used to destroy 
kidney stones. Ultrasound is capable of penetrating deep through tissue 
without tissue damage because the frequency of the waves can be 
adjusted to be absorbed only by the target, here carbon, boron-nitride, 
or other nanostructures. The technique can also be used to deliver 
substances that are cytotoxic to tumor cells, encapsulated inside the 
nanostructures. Once the IgG delivers drug-filled nanostructures to the 
tumor, ultrasonic waves are used to break open the nanostructures and 
release the tumor toxic substances. In each case, antibodies 
(immunoglobulins (IgGs)) are used to carry nanotubes specifically to a 
tumor and ultrasonic waves are used to either explode or break open the 
nanotubes, destroying the tumor. The covalent attachment of the carbon 
nanotubes to the antibody will rely on the terminal carbon atoms of 
each tube. Hydrogen atoms covalently liked to the carbon can be 
nitrogenated to facilitate later attachment to IgG through a linker:

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    Inventors: Jon G. Wilkes (FDA), Dan A. Buzatu (FDA), Dwight W. 
Miller (FDA), Jerry A. Darsey (Univ Arkansas), Thomas M. Heinze (FDA), 
Alexandru S. Biris (Univ Arkansas), Mark Diggs (Diggs & Assocs).
    Patent Status: U.S. Patent Application No. 11/005,380 filed 
December 6, 2004 (HHS Reference No. E-091-2004/0-US-01).
    Licensing Status: All licensing inquiries should be directed to 
Michael McAllister, University of Arkansas at Little Rock, Office of 
Technology Transfer, 2801 South University Avenue, Little Rock, AR 
72204-1099; Phone: 501/569-8658; E-mail: [email protected].
    NIH Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected].

Radio-Activated Boron-Nitride Nanotube-Antibody Conjugates for Cancer 
Therapy and Diagnostics

    Description of Technology: Available for licensing and commercial 
development is a cancer therapy and diagnostic that utilizes a 
variation of ``Boron Neutron Capture Therapy'' (BNCT) using radio-
activate boron-nitride (BN) nanotubes, covalently bound to tumor-cloned 
antibodies (immunoglobulins (IgGs)) to deliver intense, short-lived, 
therapeutic doses of radiation specifically to active tumor sites. The 
therapy involves activation of the BN nanotubes with a neutron beam (as 
in BNCT) once the antibody (immunoglobulin (IgG)) carrier molecules 
reach their target tissue. This invention addresses two important 
limitations in of present BNCT: (1) The ability to target accurately 
the tumor tissue, and (2) the amount of radiation, e.g., how many boron 
atoms can be delivered to the tumor site. Most molecules that are 
currently used by BNCT can only deliver one or two boron atoms per 
molecule and do so without cancer cell target specificity. Thus BNCT is 
only as specific as the columniation of the neutron-activating beam 
allows. The instant BN nanotubes can deliver significant numbers of 
boron atoms (100s to 1000s) specifically to the tumor site while 
avoiding exposures to surrounding tissue. BNCT is a technique that 
relies on (non-radioactive) \10\B delivery specifically to a tumor site 
and then activating it using an accurate beam of epithermal neutrons 
(low energy neutrons with velocities adjusted to penetrate tissue to 
the specific tumor depth where the \10\B has lodged). BN nanotube 
structure is similar to the ``rolled-up-graphite'' structure of a 
carbon nanotube, six member rings but with boron atoms bound to three 
surrounding nitrogen atoms, and the nitrogen atoms bound to surrounding 
boron atoms (no conjugation). Thus, each BN nanotube is composed of a 
substantial number of boron atoms: e.g.,--50%, meaning hundreds to 
thousands for each nanotube. Boron has a relatively large radioactive 
cross section and can be easily made radioactive in a neutron flux. 
Radioactive boron is an alpha and gamma emitter with isotopes of 12B 
and 13B, having gamma energies of 4.439MeV and 3.68MeV, respectively. 
The covalent attachment of the BN nanotubes to the antibody 
(Immunoglobulin (IgG)) will rely on the terminal nitrogen atoms of each 
tube and can be accomplished using the following linker reaction:

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[[Page 32364]]


    Inventors: Dan A. Buzatu (FDA), Jon G. Wilkes (FDA), Dwight W. 
Miller (FDA), Jerry A. Darsey (Univ Arkansas), Thomas M. Heinze (FDA), 
Alexandru S. Biris (Univ Arkansas), Richard Beger (FDA).
    Patent Status: U.S. Patent Application No. 11/005,412 filed 
December 6, 2004 (HHS Reference No. E-090-2004/0-US-01).
    Licensing Status: All licensing inquiries should be directed to 
Michael McAllister, University of Arkansas at Little Rock, Office of 
Technology Transfer, 2801 South University Avenue, Little Rock, AR 
72204-1099; Phone: 501/569-8658; E-mail: [email protected].
    NIH Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected].

    Dated: May 24, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 06-5105 Filed 6-2-06; 8:45 am]
BILLING CODE 4140-01-P