Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues
Reexamination Certificate
1993-03-08
2002-01-29
Carlson, Karen Cochrane (Department: 1653)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Reexamination Certificate
active
06342583
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention concerns nucleic acid sequences which code for carcinoembryonic antigen (CEA) antigen family peptide sequences.
2. Background Information
Carcinoembryonic antigen was first described by Gold and Freedman,
J. Exp. Med.,
121, 439-462, (1965). CEA is characterized as a glycoprotein of approximately 200,000 molecular weight with 50-60% by weight of carbohydrate. CEA is present during normal human fetal development, but only in very low concentration in the normal adult intestinal tract. It is produced and secreted by a number of different tumors.
CEA is a clinically useful tumor marker for the management of colorectal cancer patients. CEA can be measured using sensitive immunoassay methods. When presurgical serum levels of CEA are elevated, a postsurgical drop in serum CEA to the normal range typically indicates successful resection of the tumor. Postsurgical CEA levels that do not return to normal often indicate incomplete resection of the tumor or the presence of additional tumor sites in the patient. After returning to normal levels, subsequent rapid rises in serum CEA levels usually indicate the presence of metastages. Slower postsurgical rises from the normal level are most often interpreted to indicate the presence of new primary tumors not previously detected. Post surgical management of colon cancer patients is thus facilitated by the measurement of CEA.
CEA is a member of an antigen family. Because of this, the immunoassay of CEA by presently available methods is complicated by the fact that CEA is but one of several potentially reactive antigens. There have been at least sixteen CEA-like antigens described in the literature. Since some of these appear to be the same antigen described by different investigators, the actual number of different antigens is somewhat less than this number. Nonetheless, there is a complex array of cross-reactive antigens which can potentially interfere with an immunoassay of the CEA released by tumors. It is known that serum levels of CEA-like antigens are elevated in many non-cancerous conditions such an inflammatory liver diseases and also in smokers. It is important that immunoassays used for the monitoring of cancer patient status not be interfered with by these other CEA-like antigens. Conversely, it is important to be able to distinguish the antigens by immunoassays because of the possibility that different tumor types may preferentially express different forms of CEA. If so, then the ability to reliably measure the different forms of CEA can provide the means to diagnose or more successfully treat different forms of cancer.
The members of the “CEA family” share some antigenic determinants. These common epitopes are not useful in distinguishing the members of the antigen family and antibodies recognizing them are of little use for measuring tumor-specific CEA levels.
U.S. Pat. No. 3,663,684, entitled “Carcinoembryonic Antigen and Diagnostic Method Using Radioactive Iodine”, concerns purification and radioiodination of CEA for use in a RIA.
U.S. Pat. No. 3,697,638 describes that CEA is a mixture of antigens (components A and B in this case). U.S. Pat. No. 3,697,638 mentions methods for separating and radioiodinating each component and their use in specific RIA's.
U.S. Pat. No. 3,852,415, entitled “Compositions for Use in Radioimmunoassay, as Substitute for Blood Plasma Extract in Determination of Carcinoembryonic Antigen” relates to the use of a buffer containing EDTA and bovine serum albumin as a substitute for plasma as a diluent for CEA RIA's.
U.S. Pat. No. 3,867,363, entitled “Carcinoembryonic Antigens”, is directed to the isolation of CEA components A and B, their labelling and use in a RIA.
U.S. Pat. No. 3,927,193, entitled “Localization of Tumors by Radiolabelled Antibodies”, concerns the use of radiolabelled anti-CEA antibodies in whole body tumor imaging.
U.S. Pat. No. 3,956,258, entitled “Carcinoembryonic Antigens”, relates to the isolation of CEA components A and B.
U.S. Pat. No. 4,086,217, entitled “Carcinoembryonic Antigens”, is directed to the isolation of CEA components A and B.
U.S. Pat. No.4,140,753, entitled “Diagnostic Method and Reagent”, concerns the purification of a CEA isomer called CEA-S1 and its use in a RIA.
U.S. Pat. No. 4,145,336, entitled “Carcinoembryonic Antigen Isomer”, relates to the antigen CEA-S1.
U.S. Pat. No. 4,180,499, entitled “Carcinoembryonic Antigens”, describes a process for producing CEA component B.
U.S. Pat. No. 4,228,236, entitled “Process of Producing Carcinoembryonic Antigen”, is directed to the use of the established cell lines LS-174T and LS-180 or clones or derivatives thereof for the production of CEA.
U.S. Pat. No. 4,272,504, entitled “Antibody Adsorbed Support Method for Carcinoembryonic Antigen Assay”, concerns two concepts for the radioimmunoassay of CEA. First, U.S. Pat. No. 4,272,504 relates to a sample pretreatment in the form of heating to 65 to 85° C. at pH 5 to precipitate and eliminate extraneous protein. Second, it describes the use of a solid phase antibody (either on beads or tubes) as a means to capture analyte and radiolabelled CEA tracer.
U.S. Pat. No. 4,299,815, entitled “Carcinoembryonic Antigen Determination”, concerns diluting a CEA sample with water and pretreating by heating to a temperature below which precipitation of protein will occur. The pretreated sample is then immunoassayed using RIA, EIA, FIA or chemiluminescent immunoassay.
U.S. Pat. No. 4,349,528, entitled “Monoclonal Hybridoma Antibody Specific for High Molecular Weight Carcinoembryonic Antigen”, is directed to a monoclonal antibody reacting with 180 kD CEA, but not with other molecular weight forms.
U.S. Pat. No. 4,467,031, entitled “Enzyme-Immunoassay for Carcinoembryonic Antigen”, relates to a sandwich enzyme immunoassay for CEA in which the first of two anti-CEA monoclonal antibodies is attached to a solid phase and the second monoclonal is conjugated with peroxidase.
U.S. Pat. No. 4,489,167, entitled “Methods and Compositions for Cancer Detection”, describes that CEA shares an antigenic determinant with alpha-acid glycoprotein (AG), which is a normal component of human serum. The method described therein concerns a solid-phase sandwich enzyme immunoassay using as one antibody an antibody recognizing AG and another antibody recognizing CEA, but not AG.
U.S. Pat. No. 4,578,349, entitled “Immunoassay for Carcinoembryonic Antigen (CEA)”, is directed to the use of high salt containing buffers as diluents in CEA immunoassays.
EP 113072-A, entitled “Assaying Blood Sample for Carcinoembryonic Antigen—After Removal of Interfering Materials by Incubation with Silica Gel”, relates to the removal from a serum of a plasma sample of interfering substances by pretreatment with silica gel. The precleared sample is then subjected to an immunoassay.
EP 102008-A, entitled “Cancer Diagnostics Carcinoembryonic Antigen—Produced from Perchloric Acid Extracts Without Electrophoresis”, relates to a procedure for the preparation of CEA from perchloric acid extracts, without the use of an electrophoresis step.
EP 92223-A, entitled “Determination of Carcinoembryonic Antigen in Cytosol or Tissue—for Therapy Control and Early Recognition of Regression”, concerns an immunoassay of CEA, not in serum or plasma, but in the cytosol fraction of the tumor tissue itself.
EP 83103759.6, entitled “Cytosole-CEA-Measurement as Predictive Test in Carcinoma, Particularly Mammacarcinoma”, is similar to EP 92223-A.
EP 83303759, entitled “Monoclonal Antibodies Specific to Carcinoembryonic Antigen”, relates to the production of “CEA specific” monoclonal antibodies and their use in immunoassays.
WO 84/02983, entitled “Specific CEA-Family Antigens, Antibodies Specific Thereto and Their Methods of Use”, is directed to the use of monoclonal antibodies to CEA-meconium (MA)-, and NCA-specific epitopes in immunoassays designed to selectively measure each of these individual components in a sample.
All of the heretofore CEA assays utilize either monoclonal or pol
Barnett Thomas R.
Elting James J.
Kamarck Michael E.
Kretschmer Axel W.
Bayer Corporation
Carlson Karen Cochrane
Norris & McLaughlin & Marcus
Schnizer Holly
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