[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Notices]
[Pages 74546-74549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21028]


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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.

[[Page 74547]]


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.

Erythroid Progenitor Cells and Methods for Producing Parvovirus B19 
Therein

    Description of Technology: The present technology offers novel 
methods of cell culture for production of human parvovirus B19 (B19). 
B19, a common infection of children adults, is the cause of fifth 
disease. Symptoms of B19 infection are usually mild in otherwise 
healthy individuals, but some adults can suffer chronic arthopathy. 
Severe health conditions and mortality may result from B19 infection of 
immunocompromised individuals and patients with chronic hemolytic 
anemia such as sickle cell disease. In addition, B19 infection during 
pregnancy may cause hydrops fetalis and fetal death. There is no 
specific antiviral drug for B19, and some forms of chronic infection 
are difficult to diagnose. Vaccination is an effective strategy for 
other animal parvoviruses and is feasible for B19 in humans.
    B19 selectively infects erythroid progenitor cells of bone marrow, 
fetal liver and a small number of specialized cell lines. These 
specific cell lines demonstrate limited infectability and commonly 
produce little or no virus following initial inoculation with B19. 
Current methods for producing infectious B19 require phlebotomy of 
infrequently available infected donors.
    The available technology describes a method of producing pure 
populations of human erythroid progenitor cells that are fully 
permissive to B19 infection. This discovery uses CD34+ hematopoietic 
stem cells present in peripheral blood to supply erythroid progenitor 
cells, which demonstrate a significant increase in viral production 
after initial inoculation. The ability to efficiently generate 
significant amounts of infectious B19V in cells is useful for the 
development of killed or attenuated vaccines, therapeutics and 
efficient diagnostic tools for prevention and treatment of B19V. 
Furthermore, this technology would allow development of new diagnostic 
assays, which use the entire virus as the antigenic target, thus 
providing more sensitive and accurate results than current diagnostic 
tools, which rely on antibodies against a single viral protein.
    Applications: (1) Diagnosis of human parvovirus B19; (2) 
Vaccination of individuals at risk for severe effects of parvovirus 
infection; (3) Research and development of anti-parvovirus agents.
    Development Status: Preclinical data is available at this time.
    Inventors: Susan Wong and Neal Young (NHLBI).
    Related Publications: 1. MC Giarratana, L Kobari, H Lapillonne, D 
Chalmers, L Kiger, T Cynober, MC Marden, H Wajcman, L Douay. Ex vivo 
generation of fully mature human red blood cells from hematopoietic 
stem cells. Nat Biotechnol. 2005 Jan; 23(1):69-74.
    2. JM Freyssinier, C Lecoq-Lafon, S Amsellem, F Picard, R Ducrocq, 
P Mayeux, C Lacombe, S Fichelson. Purification, amplification and 
characterization of a population of human erythroid progenitors. Br J 
Haematol. 1999 Sep; 106(4):912-922.
    Patent Status: U.S. Provisional Application No. 60/808,904 filed 26 
May 2006 (HHS Reference No. E-188-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing and commercial development.
    Licensing Contact: Chekesha S. Clingman, Ph.D.; 301/435-5018; 
[email protected].
    Collaborative Research Opportunity: The NHLBI Hematology Branch is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
novel methods to produce parvovirus B19 and use as diagnostic or 
vaccine. Please contact Dr. Neal Young at 301-496-5093, 
[email protected] for more information.

Small Molecules for Imaging Protein-Protein Interactions

    Description of Technology: Imaging techniques like positron 
emission tomography and photon emission computerized tomography are 
often used with imaging agents to detect the presence and accumulation 
of amyloid plaques within the human brain. These imaging agents have 
high specificity for beta amyloid peptides, and administration of such 
agents aids in the early detection of amyloid plaques in brains of 
Alzheimer's victims. However, currently available imaging agents have 
limited success for detecting pre-plaque beta amyloid proteins because 
they are small and reside within the tissue for a short period of time. 
Therefore, new imaging agents are needed for enhanced identification of 
amyloid deposits.
    Available for licensing and commercial development are small 
molecules for imaging protein-protein interactions in Alzheimer's 
disease. This technology describes a bifunctional molecule with high 
specificity for beta amyloid proteins that is applicable for in vivo 
imaging. The molecule contains two moieties with different binding 
affinities, one moiety has an affinity for amyloid beta proteins, and 
the other moiety has an affinity for a tissue-specific chaperone. The 
different moieties of the subject invention are conjoined by an inert 
linkage group, typically comprised of a hydrocarbon chain, peptide, or 
carbohydrate. The subject invention is affixed with a label, such as a 
fluorophore or radioisotope, which adheres to the binding site of the 
beta amyloid protein, the chaperone, or the linkage group. The choice 
of label makes the subject invention versatile and employable in 
several types of imaging modalities such as single photon emission 
computed tomography (SPECT), positron emission tomography (PET), 
magnetic resonance imaging (MRI), and computerized tomography (CT) 
scans.
    Applications: (1) Applicable for identification of beta amyloid 
plaques in patients with or at risk for Alzheimer's disease and pre-
plaque amyloid beta proteins; (2) Applicable for in vivo imaging 
protein-protein interactions using small molecules; (3) Applicable for 
image guided therapy of Alzheimer's disease.
    Market: (1) Alzheimer's disease affects approximately 4.5 million 
people within the United States; (2) The direct and indirect annual 
costs associated with Alzheimer's disease are at least $100 billion.
    Development Status: Pre-clinical data is available.
    Inventors: King C. Li and S. Narasimhan Danthi (CC).
    Patent Status: U.S. Provisional Application No. 60/815,740 filed 21 
Jun 2006 (HHS Reference No. E-046-2006/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Chekesha S. Clingman , Ph.D.; 301-435-5018; 
[email protected].
    Collaborative Research Opportunity: The National Institutes of 
Health Clinical Center, Laboratory of Diagnostic Radiology Research, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
Small Molecules for Imaging Protein-Protein Interactions. Please 
contact Betty Tong, Ph.D. at 301-594-4263 for more information.

[[Page 74548]]

Methods and Systems for Identifying and Classifying Drug Targets

    Description of Technology: Available for licensing and commercial 
development is a novel method for a-priori evaluation of the 
therapeutic relevance of gene products for various diseases, in order 
to make drug development more cost-efficient. In addition, this 
technology may be used to identify novel therapeutic uses for known 
drugs. For example, the current invention has the potential to uncover 
the role of an established cancer drug target, in an alternative 
disorder such as Alzheimer's disease, thus providing an additional use 
for the available cancer drug.
    The multivariable model used by the method, which is based on a 
training set of targets that have already passed FDA review, is capable 
of ranking drug targets in terms of prospective clinical success. This 
innovative approach integrates multiple datasets that describe each 
single gene product from a broad range of analyses, such as 
microarrays, x-ray crystallography, and phylogenetics, to rapidly 
characterize a proteins structure, function, and gene regulation 
information. An algorithm subsequently scores a protein's potential as 
a drug target for use in future drug design studies. The resulting set 
of targets is enriched 28-fold as compared to randomly selected gene 
products.
    Applications: (1) Early evaluation of a candidate drug target's 
potential to yield a therapeutic effect, given the target's inhibitor 
is provided; (2) Efficient discovery of novel drugs and drug targets; 
(3) Classification of genes according to their involvement in specific 
diseases.
    Development Status: The technology is ready to be used in drug 
discovery and development.
    Inventors: Anatoly L. Mayburd (NCI), James L. Mulshine (NCI), et 
al.
    Patent Status: U.S. Provisional Application No. 60/788,522 filed 31 
Mar 2006 (HHS Reference No. E-268-2005/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; [email protected].

Systems and Methods for Intelligent Quality Control of Instruments and 
Processes

    Description of Technology: Available for licensing and commercial 
development is a cost-effective system and method for evaluation of 
instruments and processes for real-time detection of error. The subject 
invention includes the capacity to identify imprecision in a variety of 
data analysis tools, which may be susceptible to malfunction. Such 
processes include instrumental analysis of patient specimens, assembly 
line manufacturing and general plant or factory operation. This system 
provides an automated platform for the dual purpose of (1) monitoring 
data to detect unusual events in real time and (2) enhancement of human 
and machine recognition and analysis of improper occurrences based on 
time-varying patterns of measured values.
    The scheme of the current system is straightforward and in general 
the method involves the following steps: (1) Collection of data 
elements from an instrument or process (2) counting data elements 
having values within predetermined intervals of the data range (3) 
applying counts of data to a neural network that monitors data trends 
and (4) production of an output based on the neural network, which 
demonstrates whether the instrument or process is generating results 
within an appropriate range. This system is advantageous because output 
is generated in real time and thus available without delay for 
immediate correction of malfunctions.
    Applications: (1) Quality control for processes and instruments; 
(2) Automated system for real time notification of malfunctions in an 
instrument or process for immediate correction of the procedure.
    Development Status: The technology is fully developed.
    Inventors: James M. Deleo (CIT) and Alan T. Remaley (CC).
    Patent Status: U.S. Patent No. 6,556,951 issued 29 Apr 2003 (HHS 
Reference No. E-042-1997/0-US-03).
    Licensing Status: Available for non-exclusive and exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; [email protected].
    Collaborative Research Opportunity: The National Institutes of 
Health Clinical Center, Radiologic and Imaging Sciences, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
Intelligent Quality Control of Instruments. Please contact Elaine Ayres 
at 301/594-3019 for more information.

Sample Delivery System With Laminar Mixing for Microvolume Biosensing

    Description of Invention: The invention is a sample delivery system 
with at least two microchannels connected to a sample chamber 
containing a biosensor. Biosensing for studying molecular recognition 
has become an important biophysical tool for biomedical research. The 
system aspirates a small sample volume into the microfluidic channels 
and applies a periodic oscillatory flow pattern to the sample. This 
prevents sample depletion in the stagnant layer across the sensor 
surface and results in efficient mixing of the sample during the 
biosensor measurement. Because the oscillatory flow pattern does not 
produce a net transport of the sample with time, there is a very long 
incubation time of the sensor surfaces with a very small sample volume. 
The new sample delivery system uses sample volumes of only 3 to 8 
microliters, compared to the 25 to 200 microliter volumes of 
conventional systems, which use cuvette principles or continuous flow 
microfluidics. The present invention is substantially better than 
existing systems with respect to biosensor contact time and required 
sample volume.
    Application: Sample delivery for biosensing.
    Development Status: A prototype of the technology is currently 
being implemented in inventor's lab and technology is ready for 
commercialization.
    Inventor: Peter Schuck (ORS).
    Publication: M Abrantes, MT Magone, LF Boyd, P Schuck. Adaptation 
of a surface plasmon resonance biosensor with microfluidics for use 
with small sample volumes and long contact times. Anal Chem. 2001 Jul 
1;73(13):2828-2835.
    Patent Status: U.S. Patent Application No. 10/415,909 filed 05 May 
2003, claiming priority to 06 Nov 2000 (HHS Reference No. E-143-2000/0-
US-03); European Patent Application No. 01990651.0 filed 11 Jun 2001 
(HHS Reference No. E-143-2000/0-EP-04).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected].
    Collaborative Research Opportunity: The NIH Office of Research 
Services, Division of Bioengineering and Physical Science, Protein 
Biophysics Resource, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize this Sample Delivery System technology. 
Please contact Dr. Peter Schuck at 301-435-1950 or 
[email protected] for more information.

[[Page 74549]]

Vaccine for Dengue Virus

    Description of Technology: The claimed invention relates to viable 
chimeric dengue viruses or their derived recombinant mutants for use as 
vaccines against dengue and other flavivirus diseases, including tick-
borne encephalitis and West Nile encephalitis. Dengue is a mosquito-
transmitted viral disease which occurs in tropical and subtropical 
regions throughout the world. Inactivated whole dengue virus vaccines 
have been shown to be insufficiently immunogenic and live dengue virus 
vaccines prepared by serial passage in cell culture have not been shown 
to be consistently attenuated. A dengue vaccine is still not available. 
The present invention represents a technical breakthrough, which 
provides new approaches to dengue vaccines by construction of chimeric 
dengue viruses of all four serotypes and strategic modification to 
produce attenuated virus strains. Several fields of use remain 
available for licensing.
    Applications: Prevention of dengue outbreaks, severe and fatal 
dengue caused by dengue viruses, a major public health problem in 
tropical and subtropical regions.
    Inventors: Ching-juh Lai, et al. (NIAID).
    Patent Status: U.S. Patent 6,184,024 issued 06 Feb 2001 (HHS 
Reference No. E-171-1988/1-US-02); U.S. Patent 6,676,926 issued 13 Jan 
2004 (HHS Reference No. E-171-1988/1-US-03).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].

Murine Monoclonal Antibodies Effective To Treat Respiratory Syncytial 
Virus

    Description of Technology: Available for licensing through a 
Biological Materials License Agreement are the murine MAbs described in 
Beeler et al, ``Neutralization epitopes of the F glycoprotein of 
respiratory syncytial virus: effect of mutation upon fusion function,'' 
J Virol. 1989 Jul;63(7):2941-2950. The MAbs that are available for 
licensing are the following: 1129, 1153, 1142, 1200, 1214, 1237, 1112, 
1269, and 1243. One of these MAbs, 1129, is the basis for a humanized 
murine MAb (see U.S. Patent 5,824,307 to humanized 1129 owned by 
MedImmune, Inc.), recently approved for marketing in the United States. 
MAbs in the panel reported by Beeler et al. have been shown to be 
effective therapeutically when administered into the lungs of cotton 
rats by small-particle aerosol. Among these MAbs several exhibited a 
high affinity (approximately 109M-1) for the RSV F glycoprotein and are 
directed at epitopes encompassing amino acid 262, 272, 275, 276 or 389. 
These epitopes are separate, nonoverlapping and distinct from the 
epitope recognized by the human Fab of U.S. Patent 5,762,905 owned by 
The Scripps Research Institute.
    Applications: Research and drug development for treatment of 
respiratory syncytial virus.
    Inventors: Robert M. Chanock, Brian R. Murphy, Judith A. Beeler, 
and Kathleen L. van Wyke Coelingh (NIAID).
    Patent Status: HHS Reference No. B-056-1994/1--Research Tool.
    Licensing Status: Available for non-exclusive licensing under a 
Biological Materials License Agreement.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].

    Dated: December 1, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-21028 Filed 12-11-06; 8:45 am]
BILLING CODE 4140-01-P