Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1994-12-16
2002-02-19
Crouch, Deborah (Department: 1632)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S209100, C424S130100, C424S184100, C424S200100, C435S235100, C435S320100, C435S252300, C435S173300, C435S242000, C435S242000, C514S002600, C514S330000
Reexamination Certificate
active
06348449
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods for introducing genetic material into the cells of an individual. The methods of the invention can be used to deliver genetic material that encodes protein targets for immunization. The methods of the present invention induce mucosal immunity.
BACKGROUND OF THE INVENTION
The direct introduction of a normal, functional gene into a living animal has been studied as a means for replacing defective genetic information. In some studies, DNA is introduced directly into cells of a living animal without the use of a viral particle or other infectious vector. Nabel, E. G., et al., (1990)
Science
249:1285-1288, disclose site-specific gene expression in vivo of a beta-galactosidase gene that was transferred directly into the arterial wall in mice. Wolfe, J. A. et al., (1990)
Science
247:1465-1468, disclose expression of various reporter genes that were directly transferred into mouse muscle in vivo. Acsadi G., et al., (1991)
Nature
352:815-818, disclose expression of human dystrophin gene in mice after intramuscular injection of DNA constructs. Wolfe, J. A., et al., 1991
BioTechniques
11(4):474-485, which is incorporated herein by reference, refers to conditions affecting direct gene transfer into rodent muscle in vivo. Felgner, P. L. and G. Rhodes, (1991)
Nature
349:351-352, disclose direct delivery of purified genes in vivo as drugs without the use of retroviruses.
The use of direct gene transfer as an alternative anti-pathogen vaccination method has been suggested. Use of direct gene transfer by single injection is suggested as a possible vaccination strategy against HIV. A cellular immune response to HIV gp120 resulting from introduction of plasmid DNA encoding the same into cells is reported to have been observed. PCT International Application Number PCT/US90/01515 published Oct. 4, 1990 discloses methods of immunizing an individual against pathogen infection by directly injecting naked polynucleotides into the individual's cells in a single step procedure. The use of transfecting agents other than lipofectins is specifically excluded from the disclosed methods. The stimulation of inoculated cells is neither disclosed nor suggested. An HIV vaccine is disclosed which consists of the introduction of polynucleotides that encode the viral protein gp120. The operability of this vaccine is not evidenced.
SUMMARY OF THE INVENTION
The present invention relates to methods of inducing mucosal immunity against proteins and peptides in an individual. The methods of the present invention comprise the step of administering by topical or lavage administration to mucosal tissue of an individual, a nucleic acid molecule that comprises a nucleotide sequence that encodes a desired peptide or protein. The mucosal tissue is selected from the group consisting of rectal, vaginal, urethral, sublingual and buccal.
The present invention relates to methods of immunizing an individual against pathogens. The methods comprise the step of inducing mucosal immunity against a pathogen antigen in an individual by administering by topical or lavage administration to the mucosal tissue of an individual, a nucleic acid molecule that comprises a nucleotide sequence that encodes a peptide which comprises at least an epitope identical or substantially similar to an epitope displayed on a pathogen antigen. The mucosal tissue is selected from the group consisting of rectal, vaginal, urethral, sublingual and buccal.
The present invention relates to methods of immunizing an individual against a hyperproliferative disease or an autoimmune disease. The methods comprise the steps of administering by topical or lavage administration to the mucosal tissue of said individual cells, a nucleic acid molecule that comprises a nucleotide sequence that encodes a peptide that comprises at least an epitope identical or substantially similar to an epitope displayed on a hyperproliferative disease-associated protein or an autoimmune disease-associated protein, respectively. The mucosal tissue is selected from the group consisting of rectal, vaginal, urethral, sublingual and buccal.
The present invention relates to pharmaceutical compositions which comprise a nucleic acid molecule and a suitable carrier or diluent for topical or lavage administration.
REFERENCES:
patent: 4224404 (1980-09-01), Viza et al.
patent: 4394448 (1983-07-01), Szoka, Jr. et al.
patent: 4806463 (1989-02-01), Goodchild et al.
patent: 4945050 (1990-07-01), Sanford et al.
patent: 5017487 (1991-05-01), Stunnenberg et al.
patent: 5036006 (1991-07-01), Sanford et al.
patent: 5185254 (1993-02-01), Linnenbach
patent: 5264618 (1993-11-01), Felgner et al.
patent: 5294441 (1994-03-01), Curtiss, III
patent: 5468485 (1995-11-01), Curtiss, III
patent: 5589466 (1996-12-01), Felgner et al.
patent: 5679647 (1997-10-01), Carson et al.
patent: 6214804 (2001-04-01), Felgner et al.
patent: WO 90/11092 (1990-10-01), None
patent: WO 91/12329 (1991-08-01), None
patent: WO 93/17706 (1993-09-01), None
patent: WO 93/23552 (1993-11-01), None
patent: WO 94/16737 (1994-08-01), None
patent: WO 94/17792 (1994-08-01), None
patent: WO 94/23738 (1994-10-01), None
patent: WO 96/14876 (1996-05-01), None
Marshall, Science, 269, 1995, 1050-1055.*
Langermann et al., Nature, 372, 1994, 552-555.*
McGhee et al., Reprod. Fertil. Dev., 6, 1994, 369-379.*
Fynan et al., DNA and Cell Biol., 12(9), 1993, 785-789.*
Staats et al., Curr. Opin. Immunol., 6, 1994, 572-583.*
Daynes et al., Ann. NY Acad. Sci, Aug. 15, 1994, 144-161.*
Service, Science, 265, 1994, 1522-1524.*
Holmgren et al., Immunobiol., 184, 1992, 157-179.*
Davis et al., Human Mol. Genetics, 2(11), 1993 1847-1851.*
Ulmer et al., Science, 259, 1993, 1745-1748.*
Tang et al., Nature, 356,1992, 152-154.*
Tijhaar et al., Vaccine 12(11): 1004-1011, 1994.*
Research News (1994) Science 269, 1522-1524.*
Editorial, “More Patent Troubles About Genes”,Nature1994, 372, 485.
Acsadi et al., “Human Dystrophin Expression in Mdx Mice After Intramuscular Injection of DNA Constructs”,Nature352: 815-818 (1991).
Anderson, W. French, “Prospects for Human Gene Therapy,”Science226:401-409, 1984.
Benoit et al., “Destruction and regeneration of skeletal muscle after treatment with a local anaesthetic, bupivacaine (Marcaine®),”J. Anat. 107:547-556, 1970.
Benvenisty et al., “Direct introduction of genes into rats and expression of the genes,”Proc. Natl. Acad. Sci. USA, 83:9551-9555, 1986.
Brandsma et al., “Use of a rapid, efficient inoculation method to induce papillomas by conttontail rabbit papillomavirus DNA shows that the E7 gene is required,”Proc. Natl. Acad. Sci. USA, 88:4816-4820, 1991.
Brigham et al., “Rapid Communication: In Vivo Transfection of Murine Lungs with a Functioning Prokaryotic Gene Using A Liposome Vehicle,”American Journal of the Medical Sciences, 298:278-281, 1989.
Butini, L. et al., “Comparative Analysis of HIV-Specific CTL Activity in Lymphoid Tissue and Peripheral Blood” J. of Cell Biochem. Suppl 18B: 147 (Abstract J306 (1994).
Dubensky et al., “Direct transfection of viral and plasmid DNA into the liver of spleen of mice,”Proc. Natl. Acad. Sci. USA, 81:7529-7533, 1984.
Felgner and Rhodes, “Gene Therapeutics”Nature 349: 351-352 (1991).
Fleckenstein et al., “Tumour induction with DNA of oncogenic primate herpesviruses,”Nature, 274:57-59, 1978.
Friedmann et al., “Progress Toward Human Gene Therapy,”Science, 244:1275-1281, 1989.
Hall-Craggs, E.C.B., “Rapid Degeneration and Regeneration of a Whole Skeletal Muscle Following Treatment with Bupivacain (Marcain),”Experimental Neurology, 43:349-358, 1974.
Haynes, B.F., “Scientific and Social Issues of Human Immunodeficiency Virus Vaccine Development” Science 260: 1279-1286 (1993).
Howley, Peter M., “Papillomavirinae and Their Replication,”Virology, Chapter 58:1625-1650, 1990.
Israel et al., “Biological Activity of Polyoma Viral DNA in Mice and Hamsters,”J. of Virology, 29:990-996, 1979.
Kaneda et al., “Increased Expression of DNA Cointroduced with Nuclear Protein in Adult Rat Liver,”Science, 243:375-378, 1989.
Klein et al., “Transformation
Ugen Kenneth E.
Wang Bin
Weiner David B.
Crouch Deborah
The Trustees of the University of Pennsylvania
Woodcock & Washburn LLP
LandOfFree
Methods of inducing mucosal immunity does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods of inducing mucosal immunity, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods of inducing mucosal immunity will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2983554