Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Blood proteins or globulins – e.g. – proteoglycans – platelet...
Reexamination Certificate
2006-07-18
2006-07-18
Ceperley, Mary E. (Department: 1641)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Blood proteins or globulins, e.g., proteoglycans, platelet...
C435S007930, C435S188000, C436S544000, C436S545000, C436S546000, C436S815000, C530S388900, C530S391300, C530S391700
Reexamination Certificate
active
07078495
ABSTRACT:
An IgG1λ monoclonal antibody to the immunosuppressive drug tacrolimus has improved properties. In particular, this monoclonal antibody, designated 1H6, has reduced cross-reactivity to several tacrolimus metabolites. This antibody is suitable for performance of immunoassays such as homogeneous immunoassays to detect or determine the presence or concentration of tacrolimus in samples such as blood samples. The invention further includes derivatives of tacrolimus derivatized at a non-binding portion of the molecule useful in immunizing antibody-producing animals and in producing such monoclonal antibodies, as well as labeled derivatives of tacrolimus useful as tacrolimus analogues in such assays. The invention further includes immunoassay methods for the detection of tacrolimus and test kits useful in performing such immunoassays.
REFERENCES:
patent: 3817837 (1974-06-01), Rubinstein et al.
patent: 5532137 (1996-07-01), Niwa et al.
patent: 5635406 (1997-06-01), Grenier et al.
patent: 0293892 (1988-12-01), None
patent: WO-94/04700 (1994-03-01), None
patent: WO 94/25022 (1994-11-01), None
L. Backman et al, Transplantation, 57(4): 519-525 (1994).
Exhibit 4 is a publication, G. Wiederrecht et al., “The Mechanism of Action of FK-506 and Cyclosporin A,”Ann. N.Y. Acad. Sci.696:9-19 (1993).
Exhibit 5 is a publication, M.L. Clearly & J. Sklar, “Lymphoproliferative Disorders in Cardiac Transplant Recipients are Multiclonal Lymphomas,”Lancet2:49-493 (1984).
Exhibit 6 is a publication, L.J. Swinnen et al., “Increased Incidence of Lymphoproliferative Disorder After Immunosuppression with a Monoclonal Antibody OKT3 in Cardiac-Transplant Recipients,”N. Engl. J. Med.323:1723-1728 (1990).
Exhibit 7 is a publication, B.Z. Katz et al., “Latent and Replicating Forms of Epstein-Barr Virus DNA and Lymphomas in Lymphoproliferative Diseases,”J. Infect. Dis.,160:589-598 (1989).
Exhibit 8 is a publication, J.S. Huston et al., “Protein Engineering of Antibody Binding Sites: Recovery of Specific Activity in an Anti-Digoxin Single-Chain Fv Analog Produced inEscherichia coli,”Proc. Natl. Acad. Sci. USA85:5879-5883 (1988).
Exhibit 9 is a publication, G.T. Hermanson, “Bioconjugate Techniques” (Academic Press, San Diego, 1996), pp. 570-592.
Exhibit 10 is a publication, P.J. Taylor et al., “Sensitive, Specific Quantitative Analysis of Tacrolimus (FK506) in Blood by Liquid Chromatography-Electrospray Tandem Mass Spectrometry,”Clin. Chem.42: 279-285 (1996).
Exhibit 11 is a publication abstract, H.J. Jeong et al., “New Monoclonal Antibody for the Immunosuppressive Drug Tacrolimus,”Ther. Drug. Monit.21: 444 (Aug. 1999), Abstract No. 65.
Exhibit 12 is a publication abstract, V.W. Armstrong et al., “Evaluation of an EMIT® Tacrolimus Assay: Comparison with Pentamer Formation Assay and Tacrolimus II MEIA,”Ther. Drug. Monit.21: 448 (Aug. 1999), Abstract No. 80.
Publication, J.M. Murthy et al., “Tacrolimus Metabolite Cross-Reactivity in Different Tacrolimus Assays,”Clin. Biochem.31: 613-617 (1998).
Publication, A.M. Akak, “Measurement of Tacrolimus (FK506) and Its Metabolites: A Review of Assay Development and Application in Therapeutic Drug Monitoring and Pharmacokinetic Studies,”Ther. Drug. Monit.19:338-351 (1997).
Davalian Dariush
Jeong Henry
Kasper Kenneth Cornell
Liu Hshiou-ting
Miller Paul Levi
Ceperley Mary E.
Dade Behring Inc.
Farber Michael B.
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