Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
2007-05-08
2007-05-08
Horlick, Kenneth R. (Department: 1637)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S091200, C435S091100, C536S024300
Reexamination Certificate
active
10344815
ABSTRACT:
A molecular marker-based method for monitoring and detecting cancer in humans. Aberrant methylation of gene promoters is a marker for cancer risk in humans. A two-stage, or “nested” polymerase chain reaction method is disclosed for detecting methylated DNA sequences at sufficiently high levels of sensitivity to permit cancer screening in biological fluid samples, such as sputum, obtained non-invasively. The method is for detecting the aberrant methylation of the p16 gene, O 6-methylguanine-DNA methyltransferase gene, Death-associated protein kinase gene, RAS-associated family 1 gene, or other gene promoters. The method offers a potentially powerful approach to population-based screening for the detection of lung and other cancers.
REFERENCES:
patent: 4683202 (1987-07-01), Mullis
patent: 5556773 (1996-09-01), Yourno
patent: 5565331 (1996-10-01), Tessier-Lavigne et al.
patent: 5693467 (1997-12-01), Roblin, III et al.
patent: 5786146 (1998-07-01), Herman et al.
patent: 5843649 (1998-12-01), Stoerker et al.
patent: 5871917 (1999-02-01), Duffy
patent: 5948624 (1999-09-01), Rothschild et al.
patent: 5965722 (1999-10-01), Ecker et al.
patent: 6017704 (2000-01-01), Herman et al.
patent: 6033858 (2000-03-01), Bastian
patent: 6117635 (2000-09-01), Nazarenko et al.
patent: 6143504 (2000-11-01), Das et al.
patent: 6200756 (2001-03-01), Herman et al.
patent: 6251594 (2001-06-01), Gonzalgo et al.
patent: 6255293 (2001-07-01), Kimchi
patent: 6331393 (2001-12-01), Laird et al.
patent: 6709818 (2004-03-01), Nelson et al.
patent: 6818404 (2004-11-01), Shuber
patent: 0 519 338 (1991-06-01), None
patent: 406090756 (1994-04-01), None
patent: WO99/63110 (1999-12-01), None
patent: WO 01/06005 (2001-01-01), None
Sato et al. Hum. Genet. 1998, vol. 103, p. 96-101.
Hendricks et al. Cancer Research, 1997, vol. 57, p. 2112-2115.
Virmani et al. Journal of the National Cancer Institute, Aug. 16, 2000, vol. 92(16), p. 1303-1307.
Ahrendt, S.A., et al., “Mollecular Detection of Tumor Cells in Bronchoalveolar Lavage Fluid from Patients with Early Stage Lung Cancer,”J Natl. Cancer Inst., vol. 91, No. 4, pp. 332-339 (Feb. 17, 1999).
Belinsky, S.A., et al., “aberrant Methylation ofp16OML4ais an Early Event in Lung Cancer and a Potential Biomarker for Early Diagnosis,”Proc. Natl. Acad. Sci. USA, vol. 95, pp. 11891-11896 (Sep. 1998).
Danbara, M., et al., “DNA Methylation Dominates Transcriptional Silencing of Pax5 in Terminally Differentiated B Cell Lines,”Molecular Immunology, vol. 38, pp. 1161-1166 (2001).
Esteller, M., et al., “Detection of Aberrant Promotor Hypermethylation of Tumor Suppressor Genes in Serus DNA from Non-Small Cell Lung Cancer Patients,”Cancer Research, vol. 59, pp. 67-70 (Jan. 1, 1999).
Esteller, M., et al., “Inactivation of the DNA Repair GeneO6-Methylguanine-DNA Methyltransferaseby Promoter Hypermethylation is a Common Event in Primary Human Neoplasia,”Cancer Research, vol. 59, pp. 793-797 (Feb. 15, 1999).
Fliss, M.S., et al., “Facile Detection of Mitochondrial DNA Mutations in Tumors and Bodily Fluids,”Science, vol. 287, pp. 2017-2019, (Mar. 17, 2000).
Gazdar, A.F., et al., “Molecular Detection of Early Lung Cancer,”J Natl Cancer Inst., vol. 91, No. 4, pp. 299-301 (Feb. 17, 1999).
Gonzalgo, M.L., et al., “Identification and Characterizationof Differentially Methylated Rgions of Genomic DNA by Methylation-Sensitive Arbitrarily Primed PCR,”Cancer Research, vol. 57, pp. 594-599 (Feb. 15, 1997).
Greenblatt, M.S., “Mutations in thep53Tumor Supressor Gene: Clues to Cancer Etiology and Molecular Pathogenesis,”Cancer Research, vol. 54, pp. 4855-4878 (Sep. 15, 1994).
Hara, E., et al., “Regulation of p16CDKN2Expression and its Implications for Cell Immortalization and Senescence,”Molecular and Cellular Biology, pp. 859-867 (Mar. 1996).
Herman, J.G., et al., “Methylation-Specific PCR: A Novel PCT Assay for Methylation Status of CpG Islands,”Proc. Natl. Acad. Sci. USA, vol. 93, pp. 9821-9826 (Sep. 1996).
Huang, T.H-M, et al., “Identification of DNA Methylation Markers for Human Breast Carcinomas Using the Methylation-Sensitive Restriction Fingerprinting Technique,”Cancer Research, vol. 57, pp. 1030-1034 (Mar. 15, 1997).
Issa, J-P J., et al., “H1C1Hypermethylation is a Late Event in Hemotopoietic Neoplasms,”Cancer Research, vol. 57, pp. 1678-1681 (May 1, 1997).
Johnson, D.H., et al., “Recent Advances with Chemotherapy for NSCLC: The ECOG Experience,”Oncology, Suppl No. 2, pp. 67-69 (Jan. 1998).
Kaneko, M., et al., Peripheral Lung Cancer: Screening and Detection with Low-Dose Spiral CT Versus Radiography,Radiology, vol. 201, pp. 798-802 (Dec. 1996).
Kashiwabara, K., et al., “Correlation Between Methylation Status of thep16/CDKN2Gene and the Expression of p16 and Rb Proteins in Primary Non-Small Cell Lung Cancers,”Int. J. Cancer(Pred. Oncol.), vol. 79, pp. 215-220 (Nov. 1997).
Kratzke, R.A., et al., “Rband p16INK4aExpression in Resected Non-Small Cell Lung Tumors,”Cancer Research, vol. 56, pp. 3415-3420 (Aug. 1, 1996).
Landis, S.H., et al., “Cancer Statistics, 1998,”CA-A Cancer J for Clinicians, vol. 18, No. 1, pp. 6-29 w/ erratum (Jan./Feb. 1998).
Law, M.R., et al., “The Dose-Response Relationship Between Cigarette Consumption, Biochemical Markers and Risk of Lung Cancer,”British J of Cancer, vol. 75, No. 11, pp. 1690-1693 (1997).
Lubin, J.H., et al., “Lung Cancer in Radon-Exposed Miners and Estimation of Risk from Indoor Exposure,”J Natl Cancer Inst., vol. 87, No. 11, pp. 817-827 (Jun. 7, 1995).
Mao, L, et al., “Detection of Oncogene Mutations in Sputum Precedes Diagnosis of Lung Cancer,”Cancer Research, vol. 54, pp. 1634-1637 (Apr. 1, 1994).
Mao, L., et al., “Microsatellite Alterations as Clonal Markers for the Detection of Human Cancer,”Proc. Natl. Acad. Sci. USA, vol. 91, pp. 9871-9875 (Oct. 1994).
Palmisano, W.A., et al., “Predicting Lung Cancer by Detecting Aberrant Promoter Methylation in Sputum,”Cancer Research, vol. 60, pp. 5954-5958 (Nov. 1, 2000).
Rodenhuis, S., “RASOncogenes and Human Lung Cancer,”Lung Cancer: Principles and Practice, edited by Harvy L. Pass, et al., Lippincott-Raven Publ, Phila PA pp. 73-82 (1996).
Saccomanno, G., et al., “Development of Carcinoma of the Lung as Reflected in Exfoliated Cells,”Cancer, vol. 33, pp. 256-270 (1974).
Serrano, M., et al., “Role of theINK4aLocus in Tumor Suspension and Cell Mortality,”Cell, vol. 85, pp. 27-37, (Apr. 5, 1996).
Sone, S., et al., “Mass Screening for Lung Cancer with Mobile Spiral Computed Tomography Scanner,”The Lancet, vol. 351, pp. 1242-1245 (Apr. 25, 1998).
Swafford, D.S., et al., “Frequent Aberrant Methylation ofp16INK4AIN Primary Rat Lung Tumors,”Mollecular and Cellular Biology, pp. 1366-1374 (Mar. 1997).
Toyota, M., et al., “Identification of Differentially Methylated Sequencesin Colorectal Cancer by Methylated CpG Island Amplification,”Cancer Research, vol. 59, pp. 2307-2312 (May 15, 1999).
Toyota, M., et al., “CpG Island Methylator Phenotype in Colorectal Cancer,”Proc. Natl Acad Sci USA, vol. 96, pp. 8681-8686 (Jul. 1999).
Toyota, M., et al., Inactivation ofCACNA1G, a T-Type Calcium Channel Gene, by Aberrant Methylation of Its 5′ CpG Island in Human Tumors,Cancer Research, vol. 59, pp. 4535-4541 (Sep. 15, 1999).
Zheng, S., et al., “Correlations of Partial and Extensive Methylation at the p14ARFLocus with Reduced mRNA Expression in Colorectal Cancer Cell Lines and Clinicopathological Features in Primary Tumors,”Carcinogenesis, vol. 21, No. 11, pp. 2057-2064 (2000).
Albert, Jan , et al., “Simple, Sensitive, and Specific Detection of Human Immunodeficiency Virus Type 1 Clinical Specimens by Polyermase Chain Reaction with Nested Primers”,Journal of Clinical Microbiology, (Jul. 1990),
Belinsky Steven A.
Palmisano William A.
Horlick Kenneth R.
Lovelace Respiratory Research Institute
Peacock & Myers, P.C.
Tung Joyce
Vilven Janeen
LandOfFree
Nested methylation-specific polymerase chain reaction cancer... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Nested methylation-specific polymerase chain reaction cancer..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Nested methylation-specific polymerase chain reaction cancer... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3770948