Chemistry: analytical and immunological testing – Lipids – triglycerides – cholesterol – or lipoproteins
Reexamination Certificate
1998-09-04
2001-10-30
Le, Long V. (Department: 1641)
Chemistry: analytical and immunological testing
Lipids, triglycerides, cholesterol, or lipoproteins
C435S007100, C435S007200, C435S007210, C435S007920, C435S007930, C435S007940, C435S007950, C435S967000, C435S973000, C436S540000, C436S546000, C436S548000, C436S013000, C436S015000, C436S071000, C436S809000, C530S380000, C530S388100, C530S388150, C530S388250
Reexamination Certificate
active
06309888
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the field of coronary artery disease. More specifically, it relates to detecting with a clinically sufficient degree of diagnostic accuracy whether a human patient from the general population has coronary artery disease (“CAD”) and, if so, to determining with a clinically sufficient degree of diagnostic accuracy which stage of CAD the patient has.
Steinberg D, “Lewis A. Conner Memorial Lecture, Oxidative Modification Of LDL And Atherogenesis,”
Circulation
1997, 95: 1062-1071, notes that deaths from coronary heartdisease continue to outnumber deaths from any other single cause in the United States. Kolata, “A New Generation Of Tests To Determine Heart Trouble,”
New York Times News Service
(Nov. 26, 1995), reports that half of the 600,000 Americans who have heart attacks each year have no symptoms beforehand and that as many as 30% of heart disease patients do not have any obvious risk factors such as high blood pressure, high cholesterol levels, diabetes, or a family history of heart disease. (All of the documents mentioned or otherwise referenced herein are incorporated herein in their entireties for all purposes.)
The ability to accurately determine whether a patient has coronary artery disease and, if so, what stage the patient has, has been a long-standing (but heretofore unachieved) goal of medical science. There have been many attempts to provide monoclonal antibodies that recognize in humans and other animals various low density lipoprotein (“LDL”) substances and/or other substances that might be associated with atherosclerosis and/or thrombosis. There have also been attempts to provide methods for determining possible markers for atherosclerosis and coronary injury. See, e.g., U.S. Pat. Nos. 5,024,829, 5,026,537, 5,120,834, 5,196,324, 5,223,410, 5,362,649, 5,380,667, 5,396,886, 5,453,359, 5,487,892, 5,597,726, 5,658,729, 5,690,103, and 5,756,067; EPO Published Application 0 484 863 A1; PCT/EP97/03287 (unpublished application); PCT/EP97/03493 (unpublished application); PCT Published Application WO 94/23302; Adarns et al., “Cardiac Troponin I. A Marker With High Specificity For Cardiac Injury,”
Circulation
1993; 88(1): 101-106; American Biogenetic Sciences Inc., 1995
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24 pages (1995);
American Biogenetic Sciences, Focus on Diagnostic Tests: A Technology Analysis, Updated Full Report,
Paisley and Habermas, Inc. (Jun. 3, 1996); Antman et al., “Cardiac-Specific Troponin I Levels To Predict The Risk Of Mortality In Patients With Acute Coronary Syndromes,”
N. Eng. J. Med.
1996; 335(18): 1342-1349; AtheroGenics, Inc. Web Site (WWW.ATHEROGENICS.COM); Hamm et al., “Emergency Room Triage Of Patients With Acute Chest Pain By Means Of Rapid Testing For Cardiac Troponin T Or Troponin I,”
N. Eng. J. Med.
1997; 337(23): 1648-1653; Hammer et al., “Generation, Characterization, And Histochemical Application Of Monoclonal Antibodies Selectively Recognizing Oxidatively Modified ApoB-Containing Serum Lipoproteins,”
Arterioscler. Thromb. Vasc. Biol.
1995; 15(5): 704-713; Hoff et al., “Lesion-Derived Low Density Lipoprotein And Oxidized Low Density Lipoprotein Share A Lability For Aggregation, Leading To Enhanced Macrophage Degradation,” Arterioscler. Thromb. 1991; 11(5): 1209-1222; Hoffmeister et al., “Alterations Of Coagulation And Fibrinolytic And Kallikrein-Kinin Systems In The Acute And Post-Acute Phases In Patients With Unstable Angina Pectoris,”
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Thromb. Haemost.
1996; 76(5): 663-669; Holvoet, Collen, et al., “Correlation Between Oxidized Low Density Lipoproteins And Coronary Artery Disease In Heart Transplant Patients,” Abstract published in
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of 66th Congress of the European Atherosclerosis Society, Florence (Italy), Jul. 13-14, 1996,
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page 47; Holvoet, Collen, et al., “Oxidized Low Density Lipoproteins In Patients With Transplant-Associated Coronary Artery Disease,”
Arterioscler. Thromb. Vasc. Biol.
January 1998; 18(1): 100-107; Holvoet, Collen, et al., Presentation at 70th Scientific Session Of The American Heart Association, Orlando, Fla., November 9-12, and published in abstract form in
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1997; 96(Suppl. I): I417 (Abstract 2328); Itabe et al., “A Monoclonal Antibody Against Oxidized Lipoprotein Recognizes Foam Cells In Atherosclerotic Lesions: Complex Formation Of Oxidized Phosphatidylcholines And Polypeptides,”
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(Nov. 26, 1995); Kotani et al., “Distribution Of Immunoreactive Malondialdehyde-Modified Low-Density Lipoprotein In Human Serum,”
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However, as noted in the literature, there is no currently available method for determining with a clinically sufficient degree of diagnostic accuracy the presence of coronary artery disease in a patient and, if the disease is present, for distinguishing with a clinically sufficient degree of diagnostic accuracy between or among the non-acute (i.e., chronic) and acute stages of that disease, the non-acute stages being stable angina and presumably asymptomatic coronary artery disease and the acute stages being unstable angina and acute myocardial infarction.
For example, U.S. Pat. No. 5,380,667 (issued Jan. 10, 1995) notes that rar most individuals with heart disease are largely asymptomatic until their first heart attack, that the major risk factors thus far identified in the
Collen Désiré J.
Holvoet Paul N.
Bryan Cave LLP
Gabel Gailene R.
Gilbert Stephen P.
Le Long V.
Leuven Research & Development VZW
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