Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2011-05-17
2011-05-17
Cook, Lisa V (Department: 1641)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S007100, C436S001000, C436S501000, C436S518000, C424S009100, C424S520000, C422S001000, C422S050000, C530S300000, C530S350000
Reexamination Certificate
active
07943332
ABSTRACT:
The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.
REFERENCES:
patent: 4376110 (1983-03-01), David et al.
patent: 5227159 (1993-07-01), Miller
patent: 5234816 (1993-08-01), Terstappen
patent: 5426029 (1995-06-01), Rittershaus et al.
patent: 5525461 (1996-06-01), Rittershaus
patent: 5667981 (1997-09-01), Groffen et al.
patent: 5700649 (1997-12-01), Morton et al.
patent: 5736137 (1998-04-01), Anderson et al.
patent: 6090365 (2000-07-01), Kaminski et al.
patent: 2002/0019018 (2002-02-01), Christopherson et al.
patent: WO 00/39580 (2000-07-01), None
“Diagnostic tests, evaluation of” In: Encyclopedia of Biostatistics, Armitage & Colton, Eds., John Wiley & Sons, Inc. vol. 2, pp. 1149-1155, 1998.
“Standard error,” In: Encyclopedia of Biostatistics, Armitage & Colton, Eds., John Wiley & Sons, Inc. vol. 6, pp. 4232, 1998.
Belov et al., “Immunophenotyping of leukemias using a cluster of differentiation antibody microarray,”Cancer Res., 61:4483-9, 2001.
Binet et al., “A clincal staging system for chronic lymphocytic leukemia,”Cancer, 40:855-864, 1977.
Center for Drug Evaluation and Research, Application No. 103948/0, Clinical pharmacology and Biopharmaceutics Review(s), found at http://www.fda.gov/cder/foi
da/2000/103948—0000—Campath—ClinPharm.pdf, 2001.
Center for Drug Evaluation and Research, Application No. NDA 21174, Clinical pharmacology and Biopharmaceutics Review(s), found at http://www.fda.gov/cder/foi
da/2000/21174—MYLOTARG—biopharmr.pdf, 2000.
Center for Drug Evaluation and Research, Clinical review of BLA reference No. 97-0260 and BLA 97-0244, found at http://www.fda.gov/cder/biologics/review/ritugen112697-rl.pdf, 1997.
Dillman, “Infusion reactions associated with the therapeutic use of monoclonal antibodies in the treatment of malignancy,”Cancer and Metastasis Reviews, 18:465-71, 1999.
Durant and Fowler, “Chemiluminescent detection systems for protein blotting,” In: Protein Blotting: A Practical Approach, Chapter 11, pp. 141-152, Dunbar, B.S., Ed., Oxford University Press, Inc., 1994.
Ferrone and Pellegrino, “HL-A antigens, antibody, and complement in the lymphocytotoxic reaction,” In: Contemporary Topics in Molecular Immunology, Reisfeld and Mandy, Eds., Plenum Press, vol. 2, pp. 185-235, 1973.
Foran et al., “European phase II study of Rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphomas, immunocytoma, and small B-cell lymphocytic lymphoma,”J. Clin. Oncol., 18:317-24, 2000.
Ginaldi et al., “Levels of expression of CD52 in normal and leukemic B and T cells: correlation with in vivo therapeutic responses to CAMPATH-1H,”Leuk. Res., 22:185-191, 1998.
Haisma et al., “Antibody-antigen complex formation following injection of OC125 monoclonal antibody in patients with ovarian cancer,”Int. J. Cancer, 40:758-62, 1987.
Heegaard and Bjerrum, “Immunoblotting—General principles and procedures,” In: CRC Handbook of Immunoblotting of Proteins, Bjerrum and Heegaard, Eds., CRC Press, vol. 1, pp. 1-25, 1988.
Herold et al., “Successful treatment and re-treatment of resistant B-cell chronic lymphocytic leukemia with the monoclonal anti-CD 20 antibody rituximab,”Ann. Hematol., 79:332-5, 2000.
Manshouri et al., “Clinical relevance of circulating CD20 (cCD20) in patients with chronic lymphocytic leukemia (CLL),”Blood, 96:369a, 2000 (abstract).
Maheu et al., “Immunologic diagnosis and monitoring for chronic lymphocytic leukemia,”Cancer, 40:855-64, 1977.
Manshouri et al., “Soluble CD52 is detectable in the plasma of patients with chronic lymphocytic leukemia,”Blood, 98:149a, 2001 (abstract).
McLaughlin et al., “Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program,”J. Clin. Oncol., 16:2825-33, 1998.
Muñiz et al., “Protein sorting upon exit from the endoplasmic reticulum,”Cell, 104:313-20, 2001.
Nguyen et al., “IDEC-C2B8 anti-CD20 (Rituximab) immunotherapy in patients with low-grade non-Hodgkin's lymphoma and lymphoproliferative disorders: evaluation of response on 48 patients,”Eur. J. Haematol., 62:76-82, 1999.
Office Action, issued in U.S. Appl. No. 10/251,144, mail date: Mar. 12, 2009.
Office Action, issued in U.S. Appl. No. 10/251,144, mail date: Mar. 8, 2007.
Office Action, issued in U.S. Appl. No. 10/251,144, mail date: Feb. 23, 2006.
Office Action, issued in U.S. Appl. No. 10/251,144, mail date: Nov. 16, 2005.
Office Action, issued in U.S. Appl. No. 10/251,144, mail date: Jul. 22, 2005.
Polliach et al., “Myelomonocytic antigens are rarely expressed on B-lymphocytic leukemia cells,”Leukemia and Lymphoma, 9:125-131, 1993.
Rai et al., “Clinical staging of chronic lymphocytic leukemia,”Blood, 46:219-34, 1975.
Random House Webster's Unabridge Dictionary, 2ndEdition, New York, pp. 1242, 1998.
Reference Base, In: NIST/Sematech e-Handbook of Statistical Methods, Section 2.1.1.2, Croarkin, C & Tobias, P., Eds., available at http://www.itl.nist.gov/div898/handbook/, retrieved Apr. 22, 2008.
Sakahara et al., “Effect of circulation antigen on immunoscintigraphy of ovarian cancer patients using anti-CA125 monoclonal antibody,”Japan J. Cancer Res., 87:655-61, 1996.
Schrohenloher et al., “Circulating Antibody—Antigen complexes in human disease: possible occurence in cancer,”Ala. J. Med. Sci., 14:10-20, 1977.
Sievers, “Clinical studies of new “biologic” approaches to therapy of acute myeloid leukemia with monoclonal antibodies and immunoconjugates,”Curr. Opin. Oncol., 12:30-5, 2000.
Weiner, “An overview of monoclonal antibody therapy of cancer,”Semin. Oncol., 26:41-50, 1999.
Extended European Search Report, issued in European Application No. 09168283.1, mailed Jun. 4, 2010.
Dyer et al., “Effects of CAMPATH-1 antibodies in vivo in patients with lymphoid malignancies: influence of antibody isotype,”Blood, 73:1431-1439, 1989.
Green et al., “Application No. 103948/0—Clinical Pharmacology and Biopharmaceutics Review(s),” Apr. 27, 2001, retrieved from http://accessdata.fda.gov/drugsatfda—docs
da/2000/103948—0000—Campath—ClinPharm.pdf, retrieved on Apr. 20, 2010.
Green et al., “Application No. 103948/0—Pharmacology Review,” Apr. 27, 2001, retrieved from http://www.accessdata.fda.gov/drugsatfda—docs
da/2000/103948—0000—Campath—PharmTox.pdf, retrieved on Apr. 20, 2010.
Manshouri et al., “Soluble CD52 is detectable in the plasma of patients with chronic lymphocyte leukemia,”Blood, 98:149a, 2001.
Milennium and ILEX Partners, LP: Campath 10-14 (Alemtuzumab), May 2, 2001, retrieved from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm088606.pdf, retrieved on Apr. 20, 2010.
Rowan et al., “Cross-linking of the CAMPATH-1 antigen (CD52) mediates growth inhibition in human B- and T-lymphoma cell lines, and subsequent emergence of CD52-deficient cells,”Immunology, 95:427-436, 1998.
Albitar Maher
Keating Michael J.
Manshouri Taghi
Board of Regents , The University of Texas System
Cook Lisa V
Fulbright & Jaworski L.L.P.
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