Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
2008-07-15
2008-07-15
Horlick, Kenneth R. (Department: 1637)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S091200
Reexamination Certificate
active
11421492
ABSTRACT:
This invention relates to detection of specific extracellular nucleic acid in plasma or serum fractions of human or animal blood associated with neoplastic or proliferative disease. Specifically, the invention relates to detection of nucleic acid derived from mutant oncogenes or other tumor-associated DNA, and to those methods of detecting and monitoring extracellular mutant oncogenes or tumor-associated DNA found in the plasma or serum fraction of blood by using rapid DNA extraction followed by nucleic acid amplification with or without enrichment for mutant DNA. In particular, the invention relates to the detection, identification, or monitoring of the existence, progression or clinical status of benign, premalignant, or maligant neoplasms in humans or other animals that contain a mutation that is associated with the neoplasm through detection of the mutated nucleic acid of the neoplasm in plasma or serum fractions. The invention permits the detection of extracellular, tumor-associated nucleic acid in the serum or plasma of humans or other animals recognized as having a neoplastic or proliferative disease or in individuals without any prior history or diagnosis of neoplastic or proliferative disease. The invention provides the ability to detect extracellular nucleic acid derived from genetic sequences known to be associated with neoplasia, such as oncogenes, as well as genetic sequences previously unrecognized as being associated with neoplastic or proliferative disease. The invention thereby provides methods for early identification of colorectal, pancreatic, lung, breast, bladder, ovarian, lymphoma and all other malignancies carrying tumor-related mutations of DNA and methods for monitoring cancer and other neoplastic disorders in humans and other animals.
REFERENCES:
patent: 4965188 (1990-10-01), Mullis
patent: 5182377 (1993-01-01), Manos
patent: 5283171 (1994-02-01), Manos
patent: 5496699 (1996-03-01), Sorenson
patent: 5512439 (1996-04-01), Hornes
patent: 5512441 (1996-04-01), Ronai
patent: 5527676 (1996-06-01), Vogelstein
patent: 5527898 (1996-06-01), Bauer
patent: 5639871 (1997-06-01), Bauer
patent: 5705627 (1998-01-01), Manos
patent: 5814448 (1998-09-01), Silverstein
patent: RE36713 (2000-05-01), Vogelstein
patent: 6090566 (2000-07-01), Vogelstein
patent: 7282335 (2007-10-01), Gocke et al.
patent: WO8900206 (1989-11-01), None
patent: WO9615139 (1996-05-01), None
patent: WO9515792 (1996-06-01), None
patent: WO9734015 (1997-09-01), None
Aggarwal, et al., (Mar. 1975) “Cell-Surface-Associated Nucleic Acid in Tumorigenic Cells Made Visible with Platinum-Pyrimidine Complexes by Electron Microscopy.”Proc. Nat. Acad. Sci., vol. 72, No. 3, pp. 928-932.
Aoki et al., (Sep. 1995) “Liposome-mediatedin vivoGene Transfer of Antisense K-ras Construct Inhibits Pancreatic Tumor Dissemination in the Murine Peritoneal Cavity.”Cancer Research, 55:3810-3816.
Ausuker et al., Editions Short Protocols in Molecular Biology John Wiley & Sons, New. York pp. 72-80, 1989.
Barz et al., (1985) “Characterization of cellular and extracellular plasma membrane vesicles from a non-metastasizing lymphoma (Eb) and its metastasizing variant (EESb).”Biochimica et Biophysica Acta, 814:7-84.
Blackburn et al., (1991) “Electrochemiluminescence Detection of Immunoassays and DNA Probe Assays for Clinical Diagnostics.”Clin. Chem., vol. 37, No. 9, pp. 1534-1539.
Bobo et al., (Sep. 1990) “Diagnosis of Chylamydia trachomatis Cervical Infection by Detection of Amplified DNA with and Enzyme Immunoassay.”Journal of Clinical Microbiology, vol. 28, No. 9, 1968-973
Boland, Richard, (Sep. 1996) “Setting microsatellites free”Nature Medicine, vol. 2, No. 9, pp. 972-974.
Boom et al., (Mar. 1990) “Rapid and Simple Method for Purification of Nucleic Acids.”Journal of Clinical Microbiology, vol. 28, No. 3, pp. 495-303.
Boom et al., (Sep. 1991) “Rapid Purification of Hepatitis B Virus DNA from Serum.”Journal of Clinical Microbiology, vol. 29, No. 9, pp. 1804-1811.
Bos et al., (May 1987) “Prevalence of ras gene mutations in human colorectal cancers.”Nature, vol. 327, pp. 293-297.
Carr et al., (Nov. 1985) “Circulating Membrane Vesicles In Leukemic Blood.”Cancer Research, 45:5944-5951.
Chaubert et al., (1994) “K-ras Mutations and p53 Alterations in Neoplastic and Nonneoplastic Lesions Associated with Longstanding Ulcerative Colitis.”Amer. Jrnl. Of Path., vol. 144, No. 4, pp. 767-774.
Chen et al., (1991) “A Method to Detect ras Point Mutations in Small Subpopulations of Cells.”Analytical Biochemistry, 195:51-56.
Chen et al., (Sep. 1996) “Microsatellite alterations in plasma DNA of small cell lung cancer patients.”Nature Medicine, vol. 2, No. 9, pp. 1033-1035.
Chen et al., “Detecting Tumor-related Alteractions in Plasma or Serum DNA of patients Diagnosed with Breast Cancer,”Clinical Cancer Research, Sep. 1999 vol. 5, 2297-2302.
Cheung et al., (Oct. 1994) “Rapid and Sensitive Method for Detection of Hepatitis C Virus RNA by Using Silica Particles.” vol. 32, No. 10, pp. 2593-2597.
Chomczynski, Piotr, (1993) “A Reagent For the Single-Step Simultaneous Isolation of RNA, DNA and Proteins from Cell and Tissue Samples.”Biotechniques, vol. 15, No. 3, pp. 532-536.
Christa et al., (1992) “Nested polymerase chain reaction of cellular DNA in plasma: a rapid method to investigate th collagen type I A2 Mspl polymorphic restriction site in alcoholic patients.”Human Genetics, 88:537-540.
Chua et al., 1996, Int. J. Cancer, 69: 54-59.
Cleary et al., “Cloning and Structural Analysis of cDNAs for bcl-2 and a Hybrid bcl-2/Immunoglobulin Transcript Resulting from the t(14;18) Translocation ,” Cell. 47:19-28, Oct. 10, 1985.
Coutlee et al., (1989) “Immunodetection of DNA with Biotinylated RNA Probes: A Study of Reactivity of a Monoclonal Antibody to DNA-RNA Hybrids.”Analytical Biochemistry, 181: 96-105.
DiCesare et al., (1993) “A High-Sensitivity Electrochemiluminescence-Based Detection Systems for Automated PCR Product Quantitation.”BioTechniques, vol. 15, No. 1, pp. 152-157.
Emanuel et al., (1993) “Amplification of Specific Gene Products from Human Serum.”GATA, vol. 10, No. 6, pp. 144-146.
Fearon et al., (June 1990) “A Genetic Model for Colorectal Tumorigenesis,”Cell, vol. 61, pp. 759-767.
Fearon et al., (Oct. 1987) “Clonal Analysis of Human Colorectal Tumors.”Science, vol. 238, pp. 193-196.
Fedorov et al., (1987) DNA Assay In Human Blood Plasma. Translated fromByuleten Eksperimentsl Biologii i Meditsiny, vol. 102, No. 9, pp. 281-281.
Fey et al., (1991) “The Polymerase Chain Reaction: A New Tool for the Detection of minimal Residual Disease In Haematological Malignancies.”Eur. J. Cancer., vol. 27, No. 1, pp. 89-94.
Finney et al., (Jun. 1993) “Predisposition of Neoplastic Transformation Caused by Gene Replacement of H-rasl.”Science, vol. 260, pp. 1524-1527.
Fournie et al., (1986) “Recovery of Nanogram Quantities of DNA from Plasma and Quantitive Measurement Using Labeling by Nick Translation.”Analytical Biochemistry, 158:220/256.
Fournie et al., (Feb. 1995) “Plasma DNA as a marker of cancerous cell death. Investigation in patients suffering from lung cancer and in nude mice bearing human tumors.”Cancer Letters, 91: 221-227.
Fowke et al., (1995) “Genetic analysis of human DNA recovered from minute amounts of serum of plasma.”Journal of Immunological Methods, 180, pp. 45-51.
Gocke et al., “p53 and APC Mutations are Detectable in the Plasma and Serum of Patients with Colorectal Cancer (CRC) or Adenomas,” Annals New York Academy of Sciences, p. 44-50 (1999).
Gocke et al., “Serum BCL2/IGH DNA in Follicular Lymphoma Patients: A Minimal Residual Disease Marker,” Leukemia and Lymphoma 2000, 39 (1-2) pp. 165-172.
Greenblatt et al., (1994) “Mut
Benko Floyd A.
Gocke Christopher D.
Kopreski Michael S.
Horlick Kenneth R.
McDonnell Boehnen & Hulbert & Berghoff LLP
The Penn State Research Foundation
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