Multicellular living organisms and unmodified parts thereof and – Nonhuman animal – The nonhuman animal is a model for human disease
Reexamination Certificate
1993-11-30
2001-05-15
Hauda, Karen M. (Department: 1632)
Multicellular living organisms and unmodified parts thereof and
Nonhuman animal
The nonhuman animal is a model for human disease
C514S002600, C530S387100, C530S403000, C530S387200, C435S325000, C435S335000, C435S375000, C435S352000, C435S007200, C435S091500, C800S011000
Reexamination Certificate
active
06232522
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention is in the field of etiological agents and induction mechanisms of autoimmunity, and specifically is a method of making an animal model for autoimmune disease.
General Discussion of Autoimmunity and Autoimmune Diseases
Autoimmunity is described as an immune response mounted against self-components which ultimately results in pathogenic consequences. Diseases which result from autoimmune responses are widespread and varied in clinical presentation. One common factor shared by many of these disease entities is the lack of a known etiologic agent or triggering event for the production of these aberrant responses.
As used herein, autoimmune diseases are diseases that are primarily autoimmune, as well as diseases which do not appear to be primarily autoimmune but have immune manifestations involving immunoglobulins, antigen specific B cell surface receptors, or antigen-specific T cell receptors. Examples of diseases which fall into these categories are systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, juvenile onset diabetes mellitus, Wegener's granulomatosis, inflammatory bowel disease, polymyositis, dermatomyositis, multiple endocrine failure, Schmidt's syndrome, autoimmune uveitis, Addison's disease, adrenalitis, Graves Disease, thyroiditis, Hashimoto's thyroiditis, autoimmune thyroid disease, pernicious anemia, gastric atrophy, chronic hepatitis, lupoid hepatitis, atherosclerosis, presenile dementia, demyelating diseases, multiple sclerosis, sub acute cutaneous lupus erythematosus, hypoparathyroidism, Dressler's syndrome, myasthenia gravis, autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, pemphigus vulgaris, pemphigus, dermatitis herpetiformis, alopcia aerata, pemphigoid, scleroderma, progressive systemic sclerosis, CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangtasia), adult onset diabetes mellitus (Type II diabetes), male and female autoimmune infertility, ankylosing spondolytis, ulcerative colitis, Crohn's disease, mixed connective tissue disease, polyarteritis nodosa, systemic necrotizing vasculitis, juvenile onset rheumatoid arthritis, glomerulonephritis, atopic dermatitis, atopic rhinitis, Goodpasture's syndrome, Chagas' disease, sarcoidosis, rheumatic fever, asthma, recurrent abortion, anti-phospholipidsyndrome, farmer's lung, erythema multiforme, post cardiotomy syndrome, Cushing's syndrome, autoimmune chronic active hepatitis, bird-fancier's lung, allergic disease, allergic encephalomyelitis, toxic epidermal necrolysis, alopecia, Alport's syndrome, alveolitis, allergic alveolitis, fibrosing alveolitis, interstitial lung disease, erythema nodosum, pyoderma gangrenosum, transfusion reaction, leprosy, malaria, leshmaniasis, trypanosomiasis, Takayasu's arteritis, polymyalgia rheumatica, temporal arteritis, shistosomiasis, giant cell arteritis, ascariasis, aspergillosis, Sampter's syndrome, eczema, lymphomatoid granulomatosis, Behcet's disease, Caplan's syndrome, Kawasaki's disease, dengue, encephalomyelitis, endocarditis, endomyocardial fibrosis, endophthalmitis, erythema elevatum et diutinum, psoriasis, erythroblastosis fetalis, eosinophilic faciitis, Shulman's syndrome, Felty's syndrome, filariasis, cyclitis, chronic cyclitis, heterochronic cyclitis, Fuch's cyclitis, IgA nephropathy, Henoch-Schonlein purpura, glomerulonephritis, graft versus host disease, transplantation rejection, human immunodeficiency virus infection, echovirus infection, cardiomyopathy, Alzheimer's disease, parvovirus infection, rubella virus infection, Hodgkin's and Non-Hodgkin's lymphoma, renal cell carcinoma, multiple myeloma, Eaton-Lambert syndrome, relapsing polychondritis, malignant melanoma cryoglobulinemia, Waldenstrom's macroglobulemia, Epstein-Barr virus infection, mumps, amyotrophic lateral sclerosis, stiff man syndrome and autoimmune gonadal failure. Immunization is any procedure leading to a humoral or cellular immune response to a specific substance. An autoantigen is any protein, or portion of a protein, specifically recognized by and bound to an auto antibody. An etiologic or antigenic agent is any agent eliciting production of autoantibodies, including infectious agents such as bacteria, viruses, viroids, Rickettsia, and fungi, or environmental agents, including foods or chemicals. These agents can be protein, portions of protein, or portion of a protein in combination with a polysaccharide. An auto antibody is any immunoglobulin, antigen specific B cell surface receptor (surface immunoglobulin), or antigen specific T cell receptor binding to or immunoreactive with a self-protein or any portion of a self-protein.
Autoimmune Rheumatic Diseases
Rheumatologis illnesses encompass a large number and wide spectrum of different autoimmune diseases, such as rheumatoid arthritis, scleroderma, dermatomyositis, polymyositis, discoid lupus erythematosus, Sjogren's syndrome and systemic lupus erythematosus. For the most part, the etiologies and pathogenic mechanisms of these disorders are still unknown. One common theme in many of these maladies is the presence of substantial quantities of antibodies immunoreactive with self-components. One example of such a rheumatic disease is systemic lupus erythematosus.
Systemic Lupus Erythematosus: Prevalence, Debilitation, Diagnosis, Clinical Manifestations and Serological Findings
Systemic lupus erythematosus affects at least 100,000, and perhaps up to 500,000 people, in the United States. It is estimated that one in 1000 American Caucasian women between the ages of 14 and 65 have systemic lupus erythematosus, as are up to four of every 1000 American black women in the same age group (Harley, et al.,
Rheum. Dis. Clin. North Amer
. 14:13-56, 1988). Most of these patients have significant morbidity and mortality resulting from both the substantial major organ involvement from this disease process and from the harsh therapeutic interventions implemented in the treatment of this poorly understood clinical entity.
Due to the varied clinical presentations associated with systemic lupus erythematosus, guidelines were revised in 1982 to aid in its diagnosis (Tan, et al.,
Arthritis Rheum
. 25:1271-1277, 1982). Eleven clinical criteria were proposed, four of which must be present to classify a patient as having systemic lupus erythematosus. These criteria include a malar rash; discoid rash; photosensitivity; oral ulcers; arthritis; serositis manifest by pleuritis or pericarditis; nephritis manifest by proteinuria or cellular casts; central nervous system involvement manifest by seizures or psychosis; hematologic involvement manifest by hemolytic anemia, leukopenia, lymphopenia or thrombocytopenia; immunologic involvement manifest by LE cells, biologically false positive serologic test for syphilis or anti-Sm antibodies; anti-native DNA antibodies and anti-nuclear antibodies.
One characteristic shared by many of these patients is the presence of high titers of autoantibodies in their sera. These autoantibodies may be directed against a myriad of host components, such as ribonucleoproteins (Sm, nRNP, Ro and La), DNA, RNA, histones, erythrocytes, and immunoglobulin, as well as other characterized and uncharacterized autoantigens.
Autoantibodies and Autoantigens in Systemic Lupus Erythematosus, Associations with Clinical Manifestations and Disease Prognosis
The near universal presence of autoantibodies is the most convincing data that leads to the general conclusion that lupus is an autoimmune disease. Autoantibodies are found in the serum of the vast majority of patients. Indeed, a positive antinuclear antibody is present in over 98% of lupus patient sera when human tissue culture cells are used as substrates for the test. This result means that patients make an autoantibody that binds a constituent of self which is contained in these cells. Many, perhaps more than 50, different const
Harley John B.
James Judith A.
Scofield R. Hal
Arnall Golden & Gregory LLP
Beckerleg Anne Marie S.
Hauda Karen M.
Oklahoma Medical Research Foundation
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