[Federal Register Volume 65, Number 191 (Monday, October 2, 2000)]
[Notices]
[Pages 58777-58778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25175]


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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 agencies 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.

Method and Device for Analysis of Biological Specimens

M. Emmert-Buck (NCI), C. Englert (NCI), R. Bonner (NICHD), and L. 
Liotta (NCI)
DHHS Reference No. E-197-00/0 filed 26 Jul 2000
Licensing Contact: Uri Reichman; 301/496-7736 ext. 240; e-mail: 
[email protected]

    The invention discloses methods for selective analysis of cellular 
samples, and more particularly it provides methods for selective 
analysis of tissue samples, such as tumors. The methods include placing 
the tissue on a surface such as membrane for example, and activating 
the surface at selected sites adjacent to the cells of interest. The 
activated sites become permeable and thus transferable to fluids. The 
cells adjacent to the permeable sites can than be selectively extracted 
and their content analyzed by standard biochemical procedures or by 
applying the extract to microarray devices, such as cDNA arrays, for 
analysis of gene expression etc. The technique presents a convenient 
alternative to existing methods of tissue microdissection. For further 
convenience, the technique can be readily combined with a variety of 
analytical devices such as microarrays biochips or other devices which 
include multiple regions carrying multiple capture molecules.

Hepatitis A Virus Clones Adapted for Growth in African Green Monkey 
Kidney (AGMK) Cells and Vaccines Comprising said Clones

Robert H. Purcell et al. (NIAID)
DHHS Reference No. E-008-95/0 filed 06 Aug 1999
Licensing Specialist: Carol Salata; 301/496-7735 ext. 232; e-mail: 
[email protected]

    The present invention relates to hepatitis A virus clones adapted 
to growth in African Green Monkey Kidney Cells intended to be used as a 
live attenuated vaccine. Several cell culture-adapted strains of 
hepatitis A virus (HAV) are currently being used as inactivated 
vaccines. However, the inactivated vaccines have the limitation that 
multiple doses are required for effective immunization. Thus, a live 
vaccine could have the advantage of inducing life-long immunity 
following administration of only a single dose.
    Preclinical studies have been done using virus isolates of this 
invention. Preliminary observations suggest that some of the HM-175 P39 
virus isolates analyzed may be promising candidates for use as a live 
attenuated vaccine. HM-175 P39 clone 15 appears to have the growth and 
attenuation properties that are desirable in a live vaccine for HAV as 
it is partially attenuated for tamarins and fully attenuated for 
chimpanzees. HM-175 P39 clone 13 may also be a potential vaccine 
candidate as it replicates efficiently in tamarins, resulting in 
moderate increases in serum liver enzyme and early seroconversion to 
anti-HAV positivity but is still fully attenuated for chimpanzees.

Method of Predicting Susceptibility to HIV Infection or Progression 
of HIV Disease

Michael W. Smith, Hyoung Doo Shin, Stephen J. O'Brien (NCI)
DHHS Reference No. E-066-99/0 filed 09 Apr 1999 and DHHS Reference No. 
E-066-99/1 filed 06 Apr 2000
Licensing Contact: J. P. Kim; 301/496-7056 ext. 264; e-mail: 
[email protected]

    This invention identifies the importance of a variant in the IL 10 
gene (-592-5'A) that is commonly found in the population with HIV-1/
AIDS. Individuals that inherit one or two copies of this form of IL 10 
are at a greater risk for progression from HIV-1 infection to the 
development of clinical AIDS or death. The effects of IL 10-592 are 
particularly evident 5 years after infection. The gene variant and its 
product may be of diagnostic value in testing to determine treatment 
regimens for patients and mimicking the effect of the IL 10-5'A gene 
variant may be useful in developing therapies for HIV infection. The 
polymorphism of the present invention can be used in association with 
other alleles, such as CCR5-D32, CCR2-64I, CCR5- +.P1.+, HLA-B35 and 
HLA homozygosity, to determine an individual's susceptibility to HIV 
infection, and provide a prognosis for disease progression in those who 
have been infected. The potential therapies derived from the IL 10-592 
genetic variant may be particularly applicable to patients on triple 
drug therapy since these patients have generally been infected for a 
number of years prior to treatment.

[[Page 58778]]

Isolation of Cellular Material Under Microscopic Visualization

Liotta et al. (NCI)
Serial No. 08/203,780 filed 01 Mar 1994, issued as U.S. Patent No. 
5,843,644; Serial No. 08/544,388 filed 10 Oct 1995, issued as U.S. 
Patent No. 5,843,657; Serial No. 08/882,699 filed 25 Jun 1997; Serial 
No. 08/925,894 filed 08 Sep 1997, issued as U.S. Patent No. 6,010,888; 
Serial No. 09/388,805 filed 02 Sep 1999
Licensing Contact: J. P. Kim; 301/496-7056 ext. 264; e-mail: 
[email protected]

    The present technology provides methods and devices for the 
isolation and analysis of cellular samples on a molecular or genetic 
level. More particularly, the invention relates to methods and devices 
for the microdissection, for example, utilizing laser capture 
microdissection (LCM), and the diagnosis and analysis of cellular 
samples which may be used in combination with a number of different 
technologies that allow for analysis of enzymes, antigens, mRNA, DNA, 
and the like from pure populations or subpopulations of particular cell 
types.

Nucleic Acid Constructs Containing HIV Genes with Mutated 
Inhibitory/Instability Regions and Methods of Using Same

George N. Pavlakis, Barbara K. Felber (NCI)
Serial No. 07/858,747 filed 27 Mar 1992; U.S. Patent 5,972,596 issued 
26 Oct 1999; U.S. Patent 5,965,726 issued 12 Oct 1999; Serial No. 09/
414,117 filed 08 Oct 1999; PCT/US93/02908
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: 
[email protected]

    This invention describes methodology for modifying the inhibitory/
instability sequences (INS) of mRNA by making multiple nucleotide 
substitutions without altering the coding capacity of the mRNA of 
interest. Mutating INS allows for or increases the expression of genes 
that would otherwise have not been expressed or would have been poorly 
expressed because of the INS normally present on the mRNA transcript. 
This novel approach also improves the stability of the mRNA. These 
methods can be used to increase the production of protein from many 
genes producing, for example, growth hormone, interferons, 
interleukins, and HIV Gag and env. DNA constructs are described which 
encode Gag protein which is highly expressed and does not require HIV 
rev for production. Thus it is a potentially useful HIV DNA vaccine. 
Assays have also been developed to facilitate detection of the 
boundaries of INS sequences of any mRNA.

    Dated: September 20, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 00-25175 Filed 9-29-00; 8:45 am]
BILLING CODE 4140-01-P