Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2003-04-11
2010-02-16
Haddad, Maher M (Department: 1644)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S007900, C435S007920
Reexamination Certificate
active
07662569
ABSTRACT:
The invention provides a method of diagnosing or predicting susceptibility to a clinical subtype of Crohn's disease in a subject having Crohn's disease by determining the presence or absence of IgA anti-I2 antibodies in the subject, where the presence of the IgA anti-I2 antibodies indicates that the subject has a clinical subtype of Crohn's disease. In one embodiment, a method of the invention is practiced by further determining the presence or absence in the subject of a NOD2 variant, anti-Saccharomyces cerevisiaeantibodies (ASCA), IgA anti-OmpC antibodies, or perinuclear anti-neutrophil cytoplasmic antibodies (pANCA). The methods of the invention can be used to diagnose or predict susceptibility to a clinical subtype of Crohn's disease, for example, a fibrostenotic subtype, a subtype characterized by the need for small bowel surgery, or a subtype characterized by the absence of features of ulcerative colitis.
REFERENCES:
patent: 5691151 (1997-11-01), Braun et al.
patent: 5750355 (1998-05-01), Targan et al.
patent: 5830675 (1998-11-01), Targan et al.
patent: 5874233 (1999-02-01), Targan et al.
patent: 5916748 (1999-06-01), Targan et al.
patent: 5937862 (1999-08-01), Targan et al.
patent: 5968741 (1999-10-01), Plevy et al.
patent: 6074835 (2000-06-01), Braun et al.
patent: 6309643 (2001-10-01), Braun et al.
patent: 7138237 (2006-11-01), Targan et al.
patent: 2004/0053263 (2004-03-01), Abreu et al.
patent: WO 00/66067 (2000-11-01), None
patent: WO 01/89361 (2001-05-01), None
Immunology, 5thEdition, Kuby et al., WH Freeman, Publisher, 2003, pp. 62-67.
Targan et al., Gastroenterology, vol. 122, No. 4, Supplement, p. A-177, No. S1176.
Dubinsky et al. ‘Serum immune responses rpredict rapid disease progression among children with crohn's disease immune responses predict disease progression.’ Am. J. Gastroenterol. 101:360-367, 2006.
Landers et al. ‘IgA serum antibody reactivity with I2, a novel Crohn's disease marker: Anti-I2 level is independent from ASCA and ANCA levels, even though IgA ASCA positivity is correlated with anti-I2 positivity.’ Gastroenterology. 118(4) Suppl. 2, part 1 A348.
Abreu et al. ‘Mutations in NOD2 are associated with fibrostenosing diseas in patients with Crohn's disease.’ Gastroenterol. 123(3):679-688, 2002.
Arnott et al. ‘Sero-Reactivity to Microbial Components in Crohn's Disease is Associated with Disease Severity and Progression, but not NOD2/CARD15 Genotype. ’ Am J. Gastroenterol. 99:2376-2384, 2004.
Abreu et al., “Mutations inNOD2Are Associated With Fibrostenosing Disease in Patients with Crohn's Disease,”Gastroenterology123:679-688 (2002).
Ahmad et al., “The Molecular Classification of the Clinical Manifestations of Crohn's Disease,”Gastroenterology122:854-866 (2002).
Dalwadi et al., “The Crohn's disease-associated bacterial protein I2 is a novel enteric T cell superantigen,”Immunity15:149-158 (2001).
Gasche et al., “A simple classification of Crohn's disease: report of the Working Party for the World Congresses of Gastroenterology, Vienna 1998,”Inflamm. Bowel Dis. 6:8-15 (2000).
Greenstein et al., “Perforating and non-perforating indications for repeated operations in Crohn's disease: evidence for two clinical forms,”Gut29:588-592 (1988).
Hampe et al., “Association between insertion mutation inNOD2gene and Crohn's disease in German and British populations,”Lancet357:1925-1928 (2001).
Hugot et al., “Mapping of a susceptibility locus for Crohn's Disease on chromosome 16,” ,Nature379:821-823-(1996).
Hugot et al., “Association of NOD2 leucine-rich repeat variants with susceptibility to Crohn's disease,”Nature411:599-603 (2001).
Landers et al., “Selected Loss of Tolerance Evidenced by Crohn's Disease-Associated Immune Responses to Auto- and Microbial Antigens,”Gastroenterology123:689-699 (2002).
Lesage et al., “Card15/NOD2Mutational Analysis and Genotype-Phenotype Correlation in 612 Patients with Inflammatory Bowel Disease,”Am. J. Hum. Genet. 70:845-857 (2002).
Mow et al., “Antibodies Against the Crohn's disease (CD)-associated bacterial sequence I2 (anti-I2) are an independent marker of fibrostenosing CD,” title only, published on DDW.org website as of Feb. 21, 2003.
Ogura et al., “A frameshift mutation inNOD2associated with susceptibility to Crohn's Disease,”Nature411:603-606 (2001).
Saxon et al., “A distinct subset of antineutrophil cytoplasmic antibodies is associated with inflammatory bowel disease,”J. Allergy Clin. Immunol. 86:202-210 (1990).
Sendid et al., “Specific antibody response to oligomannosidic epitopes in Crohn's disease,”Clin. Diagn. Lab Immunol. 3:219-226 (1996).
Sugimura et al., “A novel NOD2/CARD15 haplotype conferring risk for Crohn disease in Ashkenazi Jews,”Am. J. Hum. Genet. 72:509-518 (2003).
Sutton et al., “Identification of a novel bacterial sequence associated with Crohn's disease,”Gastroenterology119:23-31 (2000).
Vasiliauskas et al., “Marker antibody expression stratifies Crohn's disease into immunologically homogeneous subgroups with distinct clinical characteristics,”Gut47:487-496 (2000).
Vasiliauskas et al., “Perinuclear antineutrophil cytoplasmic antibodies in patients with Crohn's disease define a clinical subgoup,”Gastroenteroloy110: 1810-1819 (1996).
Wei et al., “Pseudomonas fluorescensencodes the Crohn's disease-associated I2 sequence and T-cell superantigen,”Infect. Immun.70:6567-6575 (2002).
Annese et al., “Familial expression of anti-Saccharomyces cerevisiaemannan antibodies in Crohn's disease and ulcerative colitis: a GISC study.”Am. J. Gastroenterology96: 2407-2412, 2001.
Cuthbert et al., “The contribution NOD2 gene mutations to the risk and site of disease in inflammatory bowel disease.”Gastroenterology122: 867-874, 2002.
Elson, “Genes, microbes, and T cells—new therapeutic targets in Crohn's disease.”New Engl. J. Med.346: 614-616, 2002.
Helio et al., “CARD15/NOD2 gene variants are associated with familially occurring and complicated forms of Crohn's disease.”Gut52: 558-562, 2003.
Inohara et al., “Host recognition of bacterial muramyl dipeptide mediated through NOD2. Implications for Crohn's diseae”J. Biol. Chem.278: 5509-5512, 2003.
Louis et al., “Early development of stricturing or penetrating pattern in Crohm's disease is influenced by disease location, number of flares, and smoking but not by NOD2/CARD15 genotype.”Gut52: 552-557, 2003.
Mow et al., “Antibodies against the Crohn's disease (CD)-associated bacterial sequence I2 (anti-I2) are an independent marker of fibrostenosing CD.”Gastroenterolog124(4 Supple1): A2 Abstract #26, Apr. 2003.
Quinton et al., “Anti-Saccharomyces cerevisiaemannan antibodies combined with antineutrophil cytoplasmic autoantibodies in inflammatory bowel disease: prevalence and diagnostic role.”Gut42: 788-791, 1998.
Radlmayr et al., “The c-insertion mutation of the NOD2 gene is associated with fistulizing and fibrostenotic phenotypes in Crohn's disease.”Gastroenterology122: 2091-2092, 2002.
Sutton et al., “Familial expression of Anti-Saccharomyces cerevisiaemannan antibodies in affected and unaffected relatives of patients with Crohn's disease.”Gut46: 58-63, 2000.
Mow, et al., “Association of Antibody Responses to Microbial Antigens and Complications of Small Bowel Crohn's Disease.”Gastroenterology126: 414-424, 2004.
Papp, et al.; Seroreactivity to Microbial Components in Crohn's Disease is Associated with Ileal Involvement, Noninflammatory Disease Behavior and NOD2/CARD15 Genotype, But Not with Risk for Surgery in a Hungarian Cohort of IBD Patients;Inflamm Bowel Dis; vol. 13, No. 8; Aug. 2007; 984-992.
Fleshner Phillip R.
Mow William S.
Rotter Jerome I.
Targan Stephan R.
Vasiliauskas Eric A.
Cedars-Sinai Medical Center
Haddad Maher M
Rooney Nora M
Townsend and Townsend / and Crew LLP
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