Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ortho-hydroxybenzoic acid or derivative doai
Reexamination Certificate
2004-12-28
2008-08-26
Padmanabhan, Sreeni (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ortho-hydroxybenzoic acid or derivative doai
C514S160000, C514S161000, C514S162000, C514S163000, C514S164000, C514S165000, C514S166000, C514S474000
Reexamination Certificate
active
07417037
ABSTRACT:
Inflammatory bowel diseases are represented by two idiopathic disorders, which include ulcerative colitis and Crohn's disease. Ulcerative colitis is restricted to the colon and involves uncertain and inflammation of the lining (mucosa) of the large intestine. Crohn's disease, on the other hand, can involve the mucosa of the small and/or large intestine and may involve deeper layers of the bowel wall. The present invention is a combination of 5-aminosalicylic acid and one or more antioxidants (e.g., N-acetylcysteine) for treating such inflammatory bowel diseases.
REFERENCES:
patent: 4496553 (1985-01-01), Halskov
patent: 4904474 (1990-02-01), Theeuwes et al.
patent: 4980173 (1990-12-01), Halskov
patent: 5013727 (1991-05-01), Halskov
patent: 5041431 (1991-08-01), Halskov
patent: 5294630 (1994-03-01), Blake et al.
patent: 5378470 (1995-01-01), Lahr
patent: 5409711 (1995-04-01), Mapelli et al.
patent: 5519014 (1996-05-01), Borody
patent: 5541170 (1996-07-01), Rhodes et al.
patent: 5541171 (1996-07-01), Rhodes et al.
patent: 5552439 (1996-09-01), Panetta
patent: 5604231 (1997-02-01), Smith et al.
patent: 5945411 (1999-08-01), Larson et al.
patent: 5948818 (1999-09-01), Buser et al.
patent: 5973009 (1999-10-01), Tailhan-Lomont et al.
patent: 6004581 (1999-12-01), Jepsen et al.
patent: 6028095 (2000-02-01), Guglietta
patent: 6258852 (2001-07-01), Flitter et al.
patent: 6271265 (2001-08-01), Flitter et al.
patent: 6277836 (2001-08-01), Borody
patent: 6387952 (2002-05-01), Mazurek et al.
patent: 6413494 (2002-07-01), Lee et al.
patent: 6444221 (2002-09-01), Shapiro
patent: 6551620 (2003-04-01), Otterbeck
patent: 6632454 (2003-10-01), Beckert et al.
patent: 6689788 (2004-02-01), Bergeron, Jr.
patent: 6699894 (2004-03-01), Earle et al.
patent: 6717012 (2004-04-01), Wang et al.
patent: 6730702 (2004-05-01), Kono et al.
patent: 6773720 (2004-08-01), Villa et al.
patent: 6797729 (2004-09-01), Byrne et al.
patent: 2006/0141057 (2006-06-01), Harty
patent: 2003/0264409 (2006-11-01), Harty
patent: PCT/US05/09269 (2005-08-01), None
patent: WO 95/31194 (1995-11-01), None
Farinati et al, Effects of N-Acetyl-L-Cysteine in Patients with Chronic Atrophic Gastritis and Nonulcer Dyspepsia: A Phase III Pilot Study, 1997, Current Therapeutic Research, vol. 58, No. 10, pp. 724-733.
Seril et al, Inhibition of Chronic Ulcerative Colitis-Associated Colorectal Adenocarcinoma Development in a Murine Mode by N-Acetylcysteine, 2002, Carcinogenesis, vol. 23, No. 6, pp. 993-1001.
www.en.wikipedia.org (Wikipedia)—Entry titled “Propagation of Uncertainty,” last modified on Oct. 2006, pp. 1-4.
www.teacher.nsrl.rochester.edu—Description of Error Analysis, Propagation of Uncertainty, p. 10.
www.merck.com (merck Manuals)—Entries on Inflammatory Bowel Disease, Ulcerative Colitis, Collagenous Colitis and Lymphocytic Colitis, Crohn's Disease, last reviewed/revised Feb. 1, 2003.
Siddiqui et al, Antioxidatn Therapy with N-Acetylcysteine Plus Mesalamine Accelerates Mucosal Healing in a Rodent Model of Colitis, 2006, Digestive Diseases and Sciences, vol. 51, No. 4, pp. 698-705.
Jurjus et al, Animal Models of Inflammatory Bowel Disease, 2004, Journal of Pharmacological and Toxicologial Methods, vol. 50, pp. 81-92.
Ross et al, Medical Therapy for Ulcerative Colitis: The State of the Art and Beyond, 2004, Current Gastroenterology Reports, vol. 6, pp. 488-495.
Guijarro et al, Supplemental N-Acetyl-L-Cysteine Improves the Efficacy of Mesalazine in the Treatment of Mild to Moderate Ulcerative Colitis, Randomized, Placebo-Controlled, Pilot Study, Apr. 2004, Gastroenterology, vol. 126, No. 4, Suppl. 2, Abstract No. T1295.
Simmonds et al., “Antioxidant effects of aminosalicylates and potential new drugs for inflammatory bowel disease: assessment in cell-free systems and inflamed human colorectal biopsies”, Aliment Pharmacol. Ther. 1999, vol. 13, pp. 363-372.
Konstantions, A., et al. “Current theories on the causes of inflammatory bowel disease.”Gastroenterology Clinics of North America,vol. 28, No. 2: pp. 283-296; Jun. 1999.
Sands, B.E., “Novel therapies for inflammatory bowel disease.”Gastroenterology Clinics of North America,vol. 28, No. 2: pp. 323-351; Jun. 1999.
Sands, B.E., “Crohn's Disease. In: Gastrointestinal and Liver Disease.” Eds. M Feldman, LS Friedman, MH Sleisenger. Saunders; New York, 7thEdition: pp. 2005-2038; 2002.
Grisham, M.B., “Oxidants and free radicals in inflammatory bowel disease.”Lancet,vol. 344: pp. 859-861' Sep. 1994.
Krieglstein, C.F., et al., “Regulation of murine intestinal inflammation by reactive metabolites of oxygen and nitrogen: Divergent roles of superoxide and nitric oxide.”J Exp Med,vol. 194, No. 9: pp. 1207-1218; Nov. 2001.
Rachmilewitz, D., et al. “Experimental colitis is ameliorated by inhibition of nitric oxide synthase activity.”Gut,vol. 37: pp. 247-255; 1995.
McCafferty, D.M., et al., “Role of inducible nitric oxide synthase in Trinitrobenzene sulphonic acid induced colitis in mice.”Gut,vol. 45: pp. 864-873; 1999.
Ardite, E., et al., “Replenishment of glutathione levels improves mucosal function in experimental acute colitis.”Laboratory Investigation,vol. 80, No. 5: pp. 735-744; May 2000.
Naito, Y., et al. “α Phenyl-N-tert-Butylnitrone provides protection from dextran sulfate sodium-induced colitis in mice.”Antioxidants and Redox Signaling,vol. 4, No. 1: pp. 195-206; 2002.
Morris, G.P., et al., “Hapten-induced model of chronic inflammation and ulceration in the rat colon.”Gastroenterology,vol. 96: pp. 795-803; 1989.
Wallace, J.I., “Release of platelet-activating factor (PAF) and accelerated healing induced by a PAF antagonist in an animal model of chronic colitis.”Can J Physiol Pharmacol,vol. 66: pp. 422-425; 1988.
Gálvez, J., et al., “The intestinal anti-inflammatory activity of UR-12746S on reactivated experimental colitis is mediated through downregulation of cytokine production.”Inflammatory Bowel Diseases,vol. 9, No. 6: pp. 363-371; Nov. 2003.
Loguercio, C., et al., “Glutathione supplementation improves oxidative damage in experimental colitis.”Dig Liver Dis,vol. 35, No. 9: pp. 635-641; Sep. 2003.
Grisham, M.B., “A radical approach to treating inflammation.”Trends in Pharmacological Sci,vol. 21, Issue 4: pp. 119-120; Apr. 2000.
Bantel, H., et al., “Mesalazine inhibits activation of transcription factor NF-κKB in inflamed mucosa of patients with ulcerative colitis.”Am J Gastroenterol,vol. 95, No. 12: pp. 3452-3457;2000.
MacDermott, R.P., “Progress in understanding the mechanism of action of 5-aminosalicylicacid.”Am J Gastroenterol,vol. 95, No. 12: pp. 3343-3345; 2000.
Green field, S.M., et al., “Inhibition of leucocyte adhesion molecule upregulation by tumor necrosis factor α: a novel mechanism of action of sulphasalazine.”Gut,vol. 34: pp. 252-256; 1993.
Keshavarzian, A., et al., “Role of reactive oxygen metabolites in experimental colitis.”Gut,vol. 31: pp. 786-790; 1990.
Miller, M.J., et al., “SOD prevents damage and attenuates eicosanoid release in a rabbit model of necrotizing enterocolitis.”Am J Physiol,vol. 255: pp. G556-G565; 1988.
Rachmilewitz, D., et al., “Experimental colitis is ameliorated by inhibition of nitric oxide synthase activity.”Gut,vol. 37: pp. 247-255; 1995.
McCafferty, D.M., et al., “Role of inducible nitric oxide synthase in trinitrobenzene sulphonic acid induced colitis in mice.”Gut,vol. 45: pp. 864-873; 1999.
Zingarelli, B., et al., “Reduced oxidative and nitrosative damage in murine experimental colitis in the absence of inducible nitric oxide synthase.”Gut,vol. 45: pp. 199-209; 1999.
Kubes, P., et al., “Nirtic oxide and intestinal inflammation.”Am J Med,vol. 109: pp. 150-158; Aug. 1999.
Svartz, N., “Salazopyrin, a new sulfanilamide preparation.”Acta Med Scand,vo
Biotechnology Law Group
Claytor Renee
Padmanabhan Sreeni
Tahmassebi Sam K.
The Board of Regents of the University of Oklahoma
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