Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Glycoprotein – e.g. – mucins – proteoglycans – etc.
Reexamination Certificate
2011-01-14
2011-12-13
Hobbs, Lisa J (Department: 1657)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Glycoprotein, e.g., mucins, proteoglycans, etc.
C530S383000, C435S068100, C525S054100
Reexamination Certificate
active
08076463
ABSTRACT:
The present invention relates to a proteinaceous construct (also designated as polymer-VWF-conjugate) comprising plasmatic and/or recombinant von Willebrand factor (VWF), said VWF being bound to at least one physiologically acceptable polymer molecule, as well as to a complex between said proteinaceous construct and at least one factor VIII (FVIII) protein. The physiologically acceptable polymer molecule can be, for instance, polyethylene glycol (PEG) or polysialic acid (PSA). Further the present invention relates to methods for prolonging the in vivo-half-life of VWF or FVIII in the blood of a mammal having a bleeding disorder associated with functional defects of or deficiencies of at least one of FVIII or VWF.
REFERENCES:
patent: 4179337 (1979-12-01), Davis et al.
patent: 4356170 (1982-10-01), Jennings et al.
patent: 4757006 (1988-07-01), Toole, Jr. et al.
patent: 4877608 (1989-10-01), Lee et al.
patent: 4965199 (1990-10-01), Capon et al.
patent: 4970300 (1990-11-01), Fulton et al.
patent: 5122614 (1992-06-01), Zalipsky
patent: 5298643 (1994-03-01), Greenwald
patent: 5328694 (1994-07-01), Schwinn
patent: 5470954 (1995-11-01), Neslund et al.
patent: 5539063 (1996-07-01), Hakimi et al.
patent: 5565427 (1996-10-01), Freudenberg
patent: 5605884 (1997-02-01), Lee et al.
patent: 5618788 (1997-04-01), Capon et al.
patent: 5621039 (1997-04-01), Hallahan et al.
patent: 5733873 (1998-03-01), Osterberg et al.
patent: 5763401 (1998-06-01), Nayar
patent: 5846951 (1998-12-01), Gregoriadis
patent: 6005077 (1999-12-01), Schwarz et al.
patent: 6037452 (2000-03-01), Minamino et al.
patent: 6379933 (2002-04-01), Johnson et al.
patent: 6455639 (2002-09-01), Yasukohchi et al.
patent: 6566506 (2003-05-01), Greenwald et al.
patent: 6586573 (2003-07-01), Besman et al.
patent: 6864350 (2005-03-01), Harris
patent: 7199223 (2007-04-01), Bossard et al.
patent: 2004/0132640 (2004-07-01), DeFrees et al.
patent: 2004/0247634 (2004-12-01), Martinod et al.
patent: 2006/0160948 (2006-07-01), Scheiflinger et al.
patent: 0774261 (1997-05-01), None
patent: 0784632 (1997-07-01), None
patent: 0977584 (2000-02-01), None
patent: 1258497 (2002-01-01), None
patent: 1260582 (2002-11-01), None
patent: WO-86/06096 (1986-01-01), None
patent: WO-93/00357 (1993-01-01), None
patent: WO-94/29370 (1994-02-01), None
patent: WO-94/15625 (1994-07-01), None
patent: WO 94/15625 (1994-07-01), None
patent: WO-97/19701 (1997-06-01), None
patent: WO-98/25969 (1998-06-01), None
patent: WO-98/38219 (1998-09-01), None
patent: WO-00/49047 (2000-08-01), None
patent: WO-01/05434 (2001-01-01), None
patent: WO-01/37893 (2001-05-01), None
patent: WO-03/040211 (2003-05-01), None
patent: WO-2004/075923 (2004-09-01), None
patent: WO-2004/081053 (2004-09-01), None
patent: WO-2005/032581 (2005-04-01), None
patent: WO-2005/058366 (2005-06-01), None
patent: WO-97/11957 (2007-04-01), None
Avigad et al., The D-galactose oxidase of Polyporus circinatus.J. Biol. Chem., 237: 2736-43 (1962).
BI et al., Targeted disruption of the mouse factor VIII gene produces a model of haemophilia A.Nat. Genet. 10: 119-21 (1995).
Blood coagulation factor derivatives with side chain of amino acids moiety bound via coupling agent to poly:alkylene glycol [abstract], Derwent, Sep. 29, 1984, (JP 01 742043, Nippon Chemiphar Co., Mar. 15, 1993).
Brown et al., An ELISA test for the binding of von Willebrand antigen to collagen.Thromb. Res., 43: 303-11 (1986).
De Romeuf et al., Heparin binding assay of von Willebrand factor (vWF) in plasma milieu—evidence of the importance of the multimerization degree of vWF.Thromb. Hamost., 69: 436-40 (1993).
Denis et al., A mouse model of severe von Willebrand disease: defects in hemostasis and thrombosis.Proc. Natl. Acad. Sci. USA, 95: 9524-9 (1998).
Elodi, et al., Kinetics of formation of factor IXa-factor VIII complex on the surface of platelets.Thromb. Res., 21: 695-700 (1981).
European Pharmacopoeia (Ph. Eur.) 3rd Ed., 2.7.4 (1997).
Favaloro, Collagen binding assay for von Willebrand factor (VWF:CBA): detection of von Willebrands Disease (VWD), and discrimination of VWD subtypes, depends on collagen source.Thromb. Haemost., 83: 127-35 (2000).
Fernandes et al., Polysialylated asparaginase: preparation, activity and pharmacokinetics.Biochem. Biophys. Acta, 1341: 26-34 (1997).
Fischer et al., Structural analysis of recombinant von Willebrand factor: identification of hetero- and homo-dimers.FEBS Lett. 351: 345-8 (1994).
Fischer et al., Biochemical and functional characterization of recombinant von Willebrand factor produced on a large scale.Cell. Mol. Life Sci., 53: 943-50 (1997).
Fischer et al., Structural analysis of recombinant von Willebrand factor produced at industrial scale fermentation of transformed CHO cells co-expressing recombinant furin.FEBS Lett. 375: 259-62 (1995).
Girma et al. Structure-function relationship of the A1 domain of von Willebrand factor.Thromb. Haemost. 74: 156-60 (1995).
Gregoriadis et al., Polysialic acids: potential in drug delivery.Febs Lett., 315: 271-6 (1993).
Gregoriadis et al., Polysialic acids: potential in improving the stability and pharmokinetics of proteins and other therapeutics.CMLS Cell. Mol. Life Sci., 57: 1964-9 (2000).
Gregoriadis et al., Polysialylated proteins: an approach to improving enzyme stability and half-life in the blood circulation.Sciences Techniques et Pratiques STP, 9: 61-6 (1999).
Jain et al., Polysialylated insulin: synthesis, characterization and biological activity in vivo.Biochim. Biophys. Acta, 1622: 42-9 (2003).
Jain et al., Polysialylation: the natural was to improve the stability and pharmacokinetics of protein and peptide drugs,DDS&S, 4:3-9 (2004).
Jennings et al., Immunochemistry of groups A, B, and C meningococcal polysaccharide-tetanus toxoid conjugates.J. Immunol., 127: 1011-8 (1981).
Kaersgaard et al., Isolation of the factor VIII-von Willebrand factor complex directly from plasma by gel filtration.J. Chromatogr. 715: 357-67(1998).
Lankhof et al., von Willebrand factor without the A2 domain is resistant to proteolysis.Thromb. Haemost.,77: 1008-13 (1997).
Lee et al., N-terminal site-specific mono-PEGylation of epidermal growth factor.Pharm. Res., 20: 818-25 2003.
Lenting et al., An experimental model to study the in vivo survival of von Willebrand factor. Basic aspects and application to the R1205H mutation.J. Biol. Chem. 279(13): 12102-9 (2004).
Lewis et al., A facile, water-soluble method for modification of proteins with DOTA: use of elevated temperature and optimized pH to achieve high specific activity and high chelate stability in radiolabeled immunoconjugates.Bioconj. Chem., 6: 565-76 1994.
Luo et al., A hyaluronic acid-taxol antitumor bioconjugate targeted to cancer cells [abstract].Biomacromolecules, 1: 208-18 (2000).
Luo et al., Synthesis and selective cytotoxicity of a hyaluronic acid-antitumorbioconjugate [abstract].Bioconj. Chem., 10: 755-63 (1999).
MacFarlane et al., Letter: A method for assaying von Willebrand factor (ristocetin cofactor).Thromb. Diath. Haemorrh., 34: 306-8 (1975).
Migneault et al., Glutaraldehyde: behavior in aqueous solution, reaction with proteins, and application to enzyme crosslinking.Biotechniques, 37: 790-6 (2004).
Pietu et al., Production inEscherichia coliof a biologically active subfragment of von Willebrand factor corresponding to the platelet glycoprotein lb, collagen and heparin binding domains.Biochem. Biophys. Res. Commun., 164: 1339-47 (1989).
Roberts et al., Chemistry for peptide and protein PEGylation.Adv. Drug Del. Rev., 54: 459-76 (2002).
Roussi et al., Effects of human recombinant, plasma-derived and porcine von Willebrand factor in pigs with severe von Willebrand disease.Blood Coagul. Fibrinolysis, 9(4): 361-72 (1998).
Ruggeri et al., The complex multimeric composition of factor VIII/von Willebrand factor.Blood, 57(6): 1140-3 (1981).
Ruggeri, Structure and function of von Willebrand factor.Thromb. Haemost. 82: 576-84 (1999).
Saenko et al., Strategies towards a longer acting factor VIII.Haemophil, 12: 42-51 (2006).
Schlokat et al., Production of highly homogeneous and structurally intact recombinant v
Scheiflinger Friedrich
Siekmann Juergen
Turecek Peter
Baxter Healthcare S.A.
Baxter International Inc.
Hobbs Lisa J
Marshall & Gerstein & Borun LLP
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