[Federal Register Volume 70, Number 121 (Friday, June 24, 2005)]
[Notices]
[Page 36612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12597]


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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, DHHS.

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.

Infectious Particle Composition and Methods of Use Thereof

Chava Kimchi-Sarfaty and Michael M. Gottesman (NCI),
DHHS Reference No. E-138-2005/0-US-01.
Licensing Contact: Michelle A. Booden; (301) 451-7337; 
[email protected].

    Current methods for delivery of small interfering RNA (siRNA) and 
short hairpin RNA (shRNA) such as cationic lipid or polyplex delivery 
systems, do not efficiently deliver siRNAs or shRNAs into a wide range 
of cell types. Subsequent innovations have resulted in shRNA, but not 
siRNA, expression cassettes that have been adapted to be compatible 
with most DNA-based viral vector systems including retroviruses, 
adenoviruses, lentiviruses, and adeno-associated viruses. As with the 
transfer of cDNAs, all of these delivery systems require a significant 
degree of optimization and are often only useful in specific cell 
systems. Additionally, some viral vectors also have the disadvantage of 
low titer and large genome size. Further, some of the above viral 
delivery systems are dependent on helper viruses or packaging cell 
lines, and some are not able to transduce non-dividing cells, or cells 
in suspension. Also inherent in current DNA viral delivery systems is a 
lack of efficiency in delivering the DNA or RNA of interest to the 
nucleus. Instead, the DNA vector and concomitant siRNA insert remains 
in the cytoplasm.
    siRNA is emerging as a powerful tool for gene silencing and has 
much potential for anticancer and antiviral applications. However, 
efficient delivery of these specific siRNAs to the nucleus of a cell is 
an important aspect of interfering with specific DNA transcription. The 
present invention provides compositions and methods for use of 
infectious particles, such as papovavirus pseudovirions, to deliver 
siRNAs into a variety of mammalian cells. More specifically, the 
infectious particles may comprise the SV40 capsid protein VP1, 
papilloma virus capsid protein L1, polyoma virus capsid protein VP1, or 
several SV40 capsid proteins. The claims further comprise methods for 
in vivo transfer of siRNA as well as a kit comprising the infectious 
particle and instructions for use as a siRNA delivery system. This 
pseudovirions technology has proved to be an excellent alternative to 
DNA-viral vectors for siRNA delivery with high capacity, very high 
efficiency, and no viral DNA complications. The pseudovirion delivery 
technology is described in the following background publications: 
Kimchi-Sarfaty et al., Human Gene Therapy 13: 299-310, 2002; Kimchi-
Sarfaty et al., Human Gene Therapy 14: 167-177, 2003; and Kimchi-
Sarfaty et al., Gene Ther Mol Biol 8: 439-450, 2004.
    This technology is available for licensing on an exclusive or a 
non-exclusive basis. In addition to licensing, the technology is 
available for further development through collaborative research 
opportunities with the inventors.

Polyclonal Antibodies to Human Thyroid Hormone Beta Receptor, JC8-
TR[beta]1 And JC16-TR[beta]1

Dr. Sheue-yann Cheng,
DHHS Reference No. E-153-2003/0--Research Tool.
Licensing Contact: Marlene Shinn-Astor; (301) 435-4426; 
[email protected].

    In human tissues, there are five thyroid hormone receptor subtypes, 
TR[beta]1, TR[beta]2, TR[beta]3, TR[alpha]1, and TR[alpha]2. High 
affinity polyclonal and monoclonal antibodies have been developed to 
specifically recognize TR[beta] and TR[alpha]1 in human and mouse 
tissues. These antibodies have been designated as JC8-TR[beta]1 and 
JC16-TR[beta]1. These antibodies could be used by researchers worldwide 
in both clinical and research applications.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: June 15, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-12597 Filed 6-23-05; 8:45 am]
BILLING CODE 4140-01-P