Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or...
Reexamination Certificate
2006-10-10
2006-10-10
Canella, Karen A. (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
C435S006120, C435S007100, C435S007920, C435S040520, C436S501000, C436S506000, C436S536000, C436S064000
Reexamination Certificate
active
07118853
ABSTRACT:
The invention provides a variety of reagents for use in the diagnosis and management of breast cancer. The invention utilizes cDNA microarray technology to identify genes whose expression profile across a large group of tumor samples correlates with that of cytokeratin 5 and cytokeratin 17, markers for basal cells of the normal mammary lactation gland. The invention demonstrates that tumors that express cytokeratin 5/6 and/or 17 have a poor prognosis relative to tumors overall. The invention provides basal marker genes and their expression products and uses of these genes for diagnosis of breast cancer and for identification of therapies for breast cancer. In particular, the invention provides basal marker genes including cadherin3, matrix metalloproteinase 14, and cadherin EGF LAG seven-pass G-type receptor 2. The invention provides antibodies to the polypeptides expressed by these genes and methods of use thereof.
REFERENCES:
patent: 5158893 (1992-10-01), Hackett et al.
patent: WO 98/21242 (1998-05-01), None
patent: WO 98/22139 (1998-05-01), None
patent: WO 99/40434 (1999-08-01), None
Kerr and Thorpe (Immunochemistry LabFax, 1994, pp. 175-177).
Schlom (“Monoclonal Antibodies: They're More and Less Than You Think”, In: Molecular foundations of Oncology, 1991, pp. 95-133).
Abstract of Vlasoff et al (Appl Immunohistochem Mol Morphol. Sep. 2002;10(3):237-41).
Abstract of Ross and Fletcher, Stem Cells. 1998;16(6):413-28.
Abstract of Herms et al (Int J Cancer. Sep. 2000;89(5):395-402).
Abstract of Matsumoto et al (Int J Colorectal Dis. Jul. 1993;8(2):103-5).
Aas, et al., “Specific P53 Mutations are Associated with De Novo Resistance to Doxorubicin in Breast Cancer Patients”,Nat. Med. 2: 811-814, 1996.
Abbas, A. K., Lichtman, A. H. & Pober, J. S. Cellular and Molecular Immunology (Saunders, Philadelphia, 1991.
Alizadeh, et al., “Distinct Types of Diffuse Large B-Cell Lymphoma Identified by Gene Expression Profiling”,Nature, 403(6769): 503-511, 2000.
Alon, et al., “Broad Patterns of Gene Expression Revealed by Clustering Analysis of Tumor and Normal Colon Tissues Probed by Oligonucleotide Arrays”,Proc. Natl. Acad Sci USA, 96: 6745-6750, 1999.
Anderson, et al., “Prognostic Significance of TP53 Alterations in Breast Carcinoma”,Br. J. Cancer, 68:540-548, 1993.
Baxa, C. A. et al. Human Adipocyte Lipid-Binding Protein: Purification of the Protein and Cloning of its Complementary DNA,Biochemistry, 28:8683-8690, 1989.
Berns, E. M. et al. Prevalance of Amplification of the Oncogenes c-myc, HER2
eu, and int-2 in one thousand human breast tumours: correlation with steroid receptors,Eur J Cancer, 28, 697-700, 1992.
Bhargava, V., Kell, D. L., van de Rijn, M. & Warnke, R. A. Bcl-2 Immunoreactivity in Breast Carcinoma Correlates with Hormone Receptor PositivityAm J Pathol, 145:535-540, 1994.
Cahill, et al., Mutations of Mitotic Checkpoint Genes in Human Cancers,Nature, 392, 300-303, 1998.
Cho, et al., “A Genome-Wide Transcriptional Analysis of the Mitotic Cell Cycle”,Mol Cell, 2:65-73, 1998.
Chu, et al., “The Transcriptional Program of Sporulation in Budding Yeast”,Science, 282: (5393): 1421, 1998,Science, 282: 699-705, 1998.
Dairkee, S. H., Mayall, B. H., Smith, H. S. & Hackett, A. J. Monoclonal marker that predicts early recurrence of breast cancer,Lancet, 1:514, 1987.
Dairkee, S. H., Puett, L. & Hackett, A. J. Expression of Basal and Luminal Epithelium-Specific Keratins in Normal, Benign, and Malignant Breast Tissue,J Natl Cancer Inst, 80:691-695,1988.
DeRisi, et al., “Exploring the Metabolic and Genetic Control of Gene Expression on a Genomic Scale”,Science, 278: 680-686, 1997.
Eisen, et al., “DNA Arrays for Analysis of Gene Expression”,Methods Enzymol, 303, 179-205, 1999.
Eisen, et al., “Cluster Analysis and Display of Genome-Wide Expression Patterns”,Proc. Natl. Acad Sci USA, 95: 14863-14868, 1998.
Farnbrough, et al., “Diverse Signaling Pathways Activated by Growth Factor Receptors Induce Broadly Overlapping, Rather than Independent, Sets of Genes”,Cell, 97:727-741, 1999.
Galitski, et al., “Ploidy Regulation of Gene Expression”,Science, 285:251-254, 1999.
Golub, et al., “Molecular Classification of Cancer: Class Discovery and Class Prediction by Gene Expression Monitoring”,Science, 286: 531-537, 1999.
Guelstein, V. I. et al. Monoclonal antibody mapping of keratins 8 and 17 and of vimentin in normal human mammary gland, benign tumors, dysplasias and breast cancerInt J Cancer,42, 147-153, 1988.
Guerin, M., Barrois, M., Terrier, M. J., Spielmann, M. & Riou, G. Overexpression of Either c-myc or c-erbB-2/Neu Proto-Oncogenes in Human Breast Carcinomas: Correlation with Poor Prognosis,Oncogene Res, 3: 21-31, 1988.
Gusterson, B. A. et al. Distribution of myoepithelial cells and basement membrane proteins in the normal breast and in benign and malignant breast diseases,Cancer Res,42:4763-4770 1982.
Heintz, N. H., Leslie, K. O., Rogers, L. A. & Howard, P. L. Amplification of the c-erb B-2 Oncogene and Prognosis of Breast Adenocarcinoma,Arch Pathol Lab Med, 114:160-163, 1990.
Hoch, R. V., Thompson, D. A., Baker, R. J. & Weigel, R. J. GATA-3 is Expressed in Association with Estrogen Receptor in Breast CancerInt J Cancer, 84:122-128, 1999.
Iyer, et al., “The Transcriptional Program in the Response of Human Fibroblasts to Serum”,Science, 283: 83-87, 1999.
Khan, et al., “Gene Expression Profiling of Alveolar Rhabdomyosarcoma with cDNA Microarrays”,Cancer Res, 58: 5009-5013, 1998.
Leek, R. D., Kaklamanis, L., Pezzella, F., Gatter, K. C. & Harris, A. L. bcl-2 in Normal Human Breast and Carcinoma, Association with Oestrogen Receptor-Positive, Epidermal Growth Factor Receptor-Negative Tumours and in Situ Cancer,Br J Cancer, 69:135-139,1994.
Lengauer, et al., “Genetic Instabilities in Human Cancers”,Nature Genetics, 24(3):227-235, 2000.
Li, et al., “Identification of a Human Mitotic Checkpoint Gene: hsMAD2”,Science, 274: 246-248, 1996.
Malzahn, K., Mitze, M., Thoenes, M. & Moll, R. Biological and Prognostic Significance of Stratified Epithelial Cytokeratins in Infiltrating Ductal Breast Carcinomas,Virchows Arch, 433: 119-129,1998.
Miettinen, M., Lindenmayer, A. E. & Chaubal, A. Endothelial Cell Markers CD31, CD34, and BNH9 Antibody to H- and Y- Antigens—Evaluation of Their Specificity and Sensitivity in the Diagnosis of Vascular Tumors and Comparison with Von Willebrand Factor,Mod Pathol, 7:82-90 1994.
Moog-Lutz, C. et al. MLN64 Exhibits Homology with the Steroidogenic Acute Regulatory Protein (STAR) and is Over-Expressed in Human Breast CarcinomasInt J Cancer, 71:183-191,1997.
Nagle, R. B. et al. Characterization of breast carcinomas by two monoclonal antibodies distinguishing myoepithelial from luminal epithelial cells,J Histochem Cytochem,34:869-881 1986.
Osborne, et al., “The Value of Estrogen and Progesterone Receptors in the Treatment of Breast Cancer”,Cancer, 46: 2884-2888, 1980.
Pauletti, G., Godolphin, W., Press, M. F. & Slamon, D. J. Detection and Quantitation of HER-2
eu Gene Amplification in Human Breast Cancer Archival Material using Fluorescence in Situ Hybridization,Oncogene, 13:63-72, 1996.
Perou, et al., “Distinctive Gene Expression Patterns in Human Mammary Epithelial Cells and Breast Cancers”.Proc. Natl Acad Sci USA, 96:9212-9217, 1999.
Pollack, J. R. et al. Genome-Wide Analysis of DNA Copy-Number Changes Using cDNA Microarrays,Nat Genet, 23: 41-46, 999.
Prud'homme, J. F. et al. Cloning of a Gene Expressed in Human Breast Cancer and Regulated by Estrogen in MCF-7 cells,Dna4:11-21,1985.
Ronnov-Jessen, et al., “Cellular Changes Involved in Conversion of Normal to Malignant Breast; Importance of the Stromal Reaction”,Physiol, Rev, 76:69-125, 1996.
Ross, et al., “Systemic Variation in Gene Expression Patterns in Human Cancer Cell Lines”,Nature
Botstein David
Brown Patrick O.
Perou Charles M.
Ring Brian
Ross Douglas
Applied Genomics, Inc.
Board of Trustees of Leland Stanford Junior University
Canella Karen A.
Choate Hall & Stewart LLP
LandOfFree
Methods of classifying, diagnosing, stratifying and treating... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods of classifying, diagnosing, stratifying and treating..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods of classifying, diagnosing, stratifying and treating... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3634817