[Federal Register Volume 59, Number 210 (Tuesday, November 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26971]


[[Page Unknown]]

[Federal Register: November 1, 1994]


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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.

ACTION: Notice.

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    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 U.S. 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 contacting Girish C. 
Barua, Technology Licensing Specialist, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804 (telephone 301/496-7735 ext. 263; fax 
301/402-0220). A signed Confidential Disclosure Agreement will be 
required to receive copies of the patent applications. Issued patents 
may be obtained from the Commissioner of Patents, U.S. Patent and 
Trademark Office, Washington, DC 20231.

Anti-HIV Compositions Containing Native And Recombinant Peptides

Fischinger, P.J., Wong-Staal, F., Gallo, R.C., Matthews, T.J. (NCI)
Filed 23 Feb 89
Serial No. 07/314,664

    A kit containing substantially pure native and recombinant HIV 
glycoproteins is valuable for testing anti-HIV vaccines or as 
diagnostic aids for detecting HIV infection. Previously, it has been 
difficult to obtain large, pure quantities of HIV proteins for use in 
vaccines or diagnostic procedures. This kit contains deglycosylated 
envelope proteins as well as recombinant fusion molecules containing 
HIV and non-HIV amino acid sequences.

Production Of Complementary DNA Representing Hepatitis A Viral 
Sequences By Recombinant DNA Methods And Uses Therefor

Ticehurst, J., Baltimore, D., Feinstone, S.M., Purcell, R.H., 
Racaniello, V.R., Baroudy, B.M., Emerson, S.U. (NIAID)
Filed 6 Nov 91
Serial No. 07/788,262 (CIP of 07/256,135, CON of 06/654,942, CIP of 06/
536,911)

    A method for the production and use of single- and double-stranded 
(ds) cDNA representing hepatitis A virus (HAV) sequences has been 
discovered, including an infectious, full-length cDNA clone of wild-
type HAV. Large quantities of the novel HAV cDNA can be harvested at a 
relatively low cost via insertion of the cDNA molecules into a 
recombinant DNA vector and subsequent transformation in appropriate 
cells; modification of bacteria by genetic engineering permits for the 
production of ds HAV cDNA. The cDNA molecules hold substantial 
diagnostic potential because they are highly specific and very 
sensitive to HAV; they can also be used in the production of either HAV 
antigen or antibodies to HAV antigen for possible vaccine development. 
Currently, no vaccine is available for protection against HAV 
infection.

Mammalian Guanine Nucleotide-Binding Protein With An ADP-
Ribosylation Factor Domain (ARD1)

Moss, J., Mishima, K., Nightingale, M.S., Tsuchiya, M. (NHLBI)
Filed 19 Apr 93
Serial No. 08/049,473

    ADP-ribosylation factors (ARFs) constitute one family of the 
-20-kDa guanine nucleotide-binding ras superfamily. ARFs 
regulate secretory, endocytic, exocytic, and nuclear fusion events and 
activate phospholipase D and cholera toxin. ARD1 is a 64-kDa protein 
containing an ARF domain at its carboxy terminus. This invention 
includes a cell line transfected with an expression vector containing 
either rat or human ARD-1 DNA and an immunoassay kit for detecting ARD 
proteins in samples.

Hepatitis A Vaccine

Nainan, O.V., Margolis, H.S., Robertson, B.H., Brinton, M.A., Ebert, 
J.W. (CDC)
Filed 6 Jul 93
Serial No. 08/087,016 (FWC of 07/678,828)
    A hepatitis A virus (HAV) was isolated from cynomolgus macaques, 
and the capsid region of this new HAV was sequenced. It was found that 
the amino acid sequence within the immunodominant site of the capsid 
region is significantly different from that of other HAV isolates. This 
new virus is suitable for preparing a whole virus vaccine for 
preventing hepatitis A in animals and, potentially, in humans.

Hepatitis A Vaccine

Cohen, J.I., Purcell, R.H., Feinstone, S.M., Ticehurst, J.R. (NIAID)
Filed 13 Sep 93
Serial No. 08/120,646 (FWC of 07/789,640, CON of 07/462,916, CON of 07/
088,220)

    A full-length DNA analog of the hepatitis A virus genome and RNA 
transcripts of the DNA analog can be mutated to produce an infectious 
hepatitis A virus suitable for a vaccine. Prior technologies have used 
cell culture techniques, rather than recombinant DNA methods, in an 
attempt to produce an acceptable hepatitis A entity. This new method 
overcomes the difficulties associated with the random mutation 
processes that occur with conventional methods.

Nucleic Acids Of A Novel Hantavirus And Reagents For Detection And 
Prevention Of Infection

Nichol, S.T. (CDC)
Filed 7 Oct 93
Serial No. 08/133,591 (CIP of 08/084,724)

    An outbreak of acute illness in the Four-Corners region of the 
United States in the spring of 1993 has been associated with the Muerto 
Canyon strain of hantavirus. The identification of specific nucleotide 
sequence information for this virus will aid in the development of 
diagnostic assays and vaccines.

Plasmids For Efficient Expression Of Synthetic Genes In E. Coli

Fields, H.A., Khudyakov, Y. (CDC)
Filed 25 Oct 93
Serial No. 08/141,917

    This invention covers the development of a recombinant gene 
encoding the hepatitis C nucleocapsid protein, which offers to 
significantly improve the detection and diagnosis of this disease. 
Hepatitis C virus (HCV) is a recently identified agent responsible for 
most cases of post-transfusion non-A, non-B hepatitis worldwide. The N-
terminal region of the HCV polyprotein is processed into proteins C (a 
nucleocapsid) and EI and E2/NS1 (envelope proteins). Previously, there 
has been no acceptable immunoassay kit for detecting HIV infection 
because growing the virus in bacteria has been difficult. Therefore, 
there has been no large-scale source of HCV proteins from which to 
stimulate the production of antibodies for immunoassays. This problem 
has been addressed by cloning the sequence from HCV nucleocapsid 
protein and inserting it into an expression vector with a Shine-
Dalgarno, which enhances expression of the protein encoded by the 
nucleotide sequence. Thus, an E. coli can be used as a host for the 
vector, and large amounts of protein are produced even when there is 
low copy number of the vector.

Clones Encoding Mammalian ADP-Ribosylarginine Hydrolases

Moss, J., Stanley, S.J., Nightingale, M.S., Murtagh, J.J., Monaco, L., 
Takada, T. (NHLBI)
Serial No. 08/183,214 (DIV of 07/888,231)

    ADP-ribosylation of arginine residues in proteins may be involved 
in cell adhesion and is crucial for the action of cholera toxin and E. 
coli heat-labile enterotoxin, agents involved in the pathogenesis of 
cholera and traveller's diarrhoea, respectively. ADP-ribosylation is 
reversed by ADP-ribosylarginine hydrolases, which cleave the ADP-
ribose-arginine bond.
    ADP-ribosylarginine hydrolases from a variety of mammalian species 
and tissues were isolated, and the coding regions for the hydrolases 
were cloned and expressed. The availability of this new hydrolase cDNA 
and expression system provides a novel molecular approach for studying 
the role of ADP-ribosylation in cell function. The gene products may be 
useful in treating or preventing a variety of bacterial diseases, 
including cholera, that appear to be mediated via ADP-ribosylation.

Novel Anti-Mycobacterial Compositions And Their Use For The 
Treatment Of Tuberculosis And Related Diseases

Barry, C.E., Yuan, Y. (NIAID)
Filed 18 Mar 94
Serial No. 08/210,519

    This invention comprises a number of novel anti-mycobacterial 
compositions, which offer to significantly improve the treatment of 
mycobacterial infection such as tuberculosis. Mycobacterium is a genus 
of bacteria encompassing a number of organisms, many of which are 
highly pathogenic in humans. The most well known of these are M. 
tuberculosis, which causes pulmonary tuberculosis, and M. leprae, which 
causes leprosy. Tuberculosis is a major worldwide problem, especially 
among HIV-infected and other immune-compromised individuals. Present 
treatments for tuberculosis often have toxic side effects or have 
limited utility because of the growing number of multi-drug resistant 
strains of M. tuberculosis. These newly discovered anti-mycobacterial 
compounds, which are analogs of thiatetracosanoate, have been shown 
effective in the treatment of mycobacterial infections and are 
relatively nontoxic. They may be given alone or in combination with 
standard anti-mycobacterial drugs and are valuable as antiseptics as 
well as therapeutics.

    Dated October 21, 1994.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 94-26971 Filed 10-31-94; 8:45 am]
BILLING CODE 4140-01-P