Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2011-07-05
2011-07-05
Allen, Marianne P (Department: 1647)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S001100, C530S350000, C530S395000
Reexamination Certificate
active
07973009
ABSTRACT:
Methods for increasing and maintaining hematocrit in a mammal comprising administering a hyperglycosylated analog of erythropoietin are disclosed. An analog may be administered less frequently than an equivalent molar amount of recombinant human erythropoietin to obtain a comparable target hematocrit and treat anemia. Alternatively, a lower molar amount of a hyperglycosylated analog may be administered to obtain a comparable target hematocrit and treat anemia. Also disclosed are new hyperglycosylated erythropoietin analogs, methods of production of the analogs, and compositions comprising the analogs.
REFERENCES:
patent: 4397840 (1983-08-01), Takezawa et al.
patent: 4419446 (1983-12-01), Howley et al.
patent: 4667016 (1987-05-01), Lai et al.
patent: 4703008 (1987-10-01), Lin
patent: 4806524 (1989-02-01), Kawaguchi et al.
patent: 5041376 (1991-08-01), Gething et al.
patent: 5217881 (1993-06-01), Park
patent: 5218092 (1993-06-01), Sasaki et al.
patent: 5378808 (1995-01-01), D'Andrea et al.
patent: 5416071 (1995-05-01), Igari et al.
patent: 5480981 (1996-01-01), Goodwin et al.
patent: 5541158 (1996-07-01), Vance et al.
patent: 5559093 (1996-09-01), Yoshitomi et al.
patent: 5661125 (1997-08-01), Strickland
patent: 5716644 (1998-02-01), Zale et al.
patent: 6333306 (2001-12-01), Lehmann
patent: 6340742 (2002-01-01), Burg et al.
patent: 6548653 (2003-04-01), Young et al.
patent: 6583272 (2003-06-01), Bailon
patent: 7217689 (2007-05-01), Elliott et al.
patent: 7304150 (2007-12-01), Egrie et al.
patent: 2002/0037841 (2002-03-01), Papadimitriou
patent: 2002/0115833 (2002-08-01), Burg et al.
patent: A 59145/90 (1991-01-01), None
patent: 2231192 (1998-03-01), None
patent: 2284910 (1999-09-01), None
patent: 0 148 605 (1985-07-01), None
patent: 0 267 678 (1988-05-01), None
patent: 0 357 804 (1990-03-01), None
patent: 0 370 205 (1990-05-01), None
patent: 0 428 267 (1991-05-01), None
patent: 0 640 619 (1995-03-01), None
patent: 0 640 619 (1997-07-01), None
patent: 2171303 (1986-08-01), None
patent: 2172303 (1986-08-01), None
patent: WO 89/03840 (1989-05-01), None
patent: WO 90/14363 (1990-11-01), None
patent: WO 91/05867 (1991-05-01), None
patent: WO 95/05465 (1995-02-01), None
patent: 97/09996 (1997-03-01), None
patent: WO 99/02711 (1999-01-01), None
patent: WO 99/11781 (1999-03-01), None
patent: WO 00/24893 (2000-05-01), None
patent: WO 00/61169 (2000-10-01), None
patent: WO 00/67769 (2000-11-01), None
patent: WO 00/67776 (2000-11-01), None
patent: WO 01/03737 (2001-01-01), None
U.S. Appl. No. 08/479,892, filed Jun. 6, 1995, Elliott et al.
Ashwell et al., “A Protein from Mammalian Liver That Specifically Binds Galactose-Terminated Glycoproteins”,Methods Enyzmol., 50: 287-288 (1978).
Boissel et al., “Erythropoietin Structure-Function Relationships”,The Biology of Hematopoiesis, pp. 227-232 (1990).
Boissel et al., “Erythropoietin Structure-Function Relationships”,J. Biol. Chem., 268: 15983-15993 (1993).
Bontempo, John A., “Formulation Development”,Development of Biopharmaceutical Parenteral Dosage Forms, by Marcel Dekker, Inc., Chapter 5, pp. 109-142 (1997).
Bradford, Marion M., “A Rapid and Sensitive Method for the Quantitation of Microgram Quantities of Protein Utilizing the Principle of Protein-Dye Binding”,Anal. Biochem., 72: 248-254 (1976).
Briggs et al., “Hepatic Clearance of Intact and Desialylated Erythropoietin”,Am. J. Physiol., 227: 1385-1388 (1974).
Broudy et al., “Recombinant Human Erythropoietin: Purification and Analysis of Carbohydrate Linkage”,Arch. Biochem. Biophys., 265: 329-336 (1988).
Burbaum et al., “Understanding Structural Relationships in Proteins of Unsolved Three-Dimensional Structure”,Proteins-Structure, Function and Genetics, 7(2): 99-111 (1990).
Burnette, W. Neal, “Western Blotting: Electrophoretic Transfer of Proteins from Sodium Dodecyl Sulfate-Polyacrylamide Gels to Unmodified Nitrocellulose and Radiographic Detection with Antibody and Radioiodinated Protein A”,Anal. Biochem., 112: 195-203 (1981).
Cheetham et al., “NMR Structure of Human Erythropoietin and a Comparison with its Receptor Bound Conformation”,Nature Structural Biology, 5(10): 861-866 (1998).
Cheng et. al., “Effective Amplication of Long Targets from Cloned Inserts and Human Genomic DNA”,Proc. Natl. Acad. Sci. USA, 91: 5695-5699 (1994).
Chern et al., “Structural Role of Amino Acids 99-110 in Recombinant Human Erythropoietin”,Eur. J. Biochem., 202: 225-229 (1991).
Chou et al., “Prediction of the Secondary Structure of Proteins from their Amino Acid Sequence”,Adv. Enzymol, 47: 45-148 (1978).
Cotes et al., “Bio-Assay of Erythropoietin in Mice Made Polycythaemic by Exposure to Air at a Reduced Pressure”,Nature, 191: 1065-1067 (1961).
Cunningham et al., “High-Resolution Epitope Mapping of hGH-Receptor Interactions by Alanine-Scanning Mutagenesis”,Science, 244: 1081-1085 (1989).
DeLorme et al., “Role of Glycosylation on the Secretion and Biological Activity of Erythropoietin”,Biochemistry, 31: 9871-9876 (1992).
Davis et al., “Characterization of Recombinant Human Erythropoietin Produced in Chinese Hamster Ovary Cells”,Biochemistry, 26: 2633-2638 (1987).
Dorado et al., “Electrophoretic Behavior of Erythropoietin in Polyacrylamide Gel”,Biochem Medicine, 6: 238-245 (1972).
Dordal et al., “The Role of Carbohydrate in Erythropoietin Action”,Endocrinology, 116(6): 2293-2299 (1985).
Dube et al., “Glycosylation at Specific Sites of Erythropoietin is Essential for Biosynthesis, Secretion, and Biological Function”,J. Biol. Chem., 263(33): 17516-17521 (1988).
Egrie et al., “Characterization and Biological Effects of Recombinant Human Erythropoietin”,Immunobiol., 172: 213-224 (1986).
Egrie et al., “Pharmacokinetics of Recombinant Human Erythropoietin (rHuEpo) Administered to Hemodialysis (HD) Patients”,Kidney Intl., 33: (Abstract) p. 262 (1988).
Egrie et al., “The Role of Carbohydrate on the Biological Activity of Erythropoietin”,Glycoconjugate J., 10: (Abstract S7.7) p. 263 (1993).
Egrie et al, “Novel Erythropoiesis Stimulating Protein (NESP) Has a Longer Serum Half-Life and Greater in vivo Biological Activity than Recombinant Human Erythropoietin (rHuEPO)”Blood(Journal of the American Society of Hematology); 90(10) Suppl 1, Part 1; Abstract 243-I, pp. 56a-57a (1997).
Egrie et al., “Development and Characterization of Novel Erythropoiesis Stimulating Protein (NESP)”,British Journal of Cancer, 84 (suppl. 1): 3-10 (2001).
Egrie et al., “Development and Characterization of Novel Erythropoiesis Stimulating Protein (NESP)”,Nephrology Dialysis Transplantation, 16(suppl. 3): 3-13 (2001).
Elliott et al., “Characterization of Anti Erythropoietin Monoclonal Antibodies”,Blood, 74(Supp. 1), A 1228 (1989).
Elliott et al., “Secretion of Glycosylated Human Erythropoietin from Yeast Directed by thealpha-Factor Leader Region”,Gene, 79: 167-180 (1989).
Elliott et al., “An Immunological Approach to Determination of Protein Structure: Human Erythropoietin”,J. Cell. Biochem., Supp. 15G: Abstract No. R215, p. 192 (1991).
Elliott et al., “Structural Requirements for O-Linked Glycosylation of Human Erythropoietin”,Abstracts of the Protein Society, 5th Symp, Abstract No. M43 (1991).
Elliott et al., “Structural Requirements for O-Linked Glycosylation of Human Erythropoietin”, Abstract of Presentation at Keystone Symposium, Mar. 21-27, (1992).
Elliott et al., “Effect of Disulfide Bonds on the Structure and Activity of Erythropoietin”,J. Cell. Biochem., Supp. 17B,: Abstract No. E318, p. 89 (1993).
Elliott et al, “Structural Requirements for Addition of O-linked Carbohydrate to Recombinant Erythropoietin”,Biochemistry, 33(37): 11237-11245 (1994).
Elliott et al., “Isolation and Chara
Browne Jeffrey K.
Egrie Joan C.
Elliott Steven G.
Sitney Karen C.
Allen Marianne P
Amgen Inc.
DeBerry Regina M
Winter Robert B.
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