Preparation and composition of inter-alpha inhibitor...

Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Separation or purification

Reexamination Certificate

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C435S004000, C530S350000

Reexamination Certificate

active

07932365

ABSTRACT:
The invention relates to Inter-alpha inhibitor proteins (IαIp). The invention further relates to processes for purification of IαIp compositions and their use for treatment of human diseases such as sepsis and septic shock, rheumatoid arthritis, cancer and infectious diseases.

REFERENCES:
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patent: 2003/0190732 (2003-10-01), Josic
patent: WO 0163280 (2001-08-01), None
patent: WO-02/30983 (2002-04-01), None
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Lim et al. Correlation between Mortality and the Levels of Inter-Alpha Inhibitors in Plasma of Patients with Severe Sepsis. The Journal of Infectious Diseases, Sep. 15, 2003, vol. 188, pp. 919-926, especially pp. 919, 920 and 925.
Yang et al. Administration of human inter-alpha-inhibitors maintains hemodynamic stability and improves survival during sepsis. Crit. Care. Med., 2002, vol. 30, No. 3, pp. 617-622, especially pp. 617-621.
Wu et al. Delayed administration of human inter-alpha inhibitor proteins reduces mortality in sepsis. Crit. Care. Med., 2004, vol. 32, No. 8 pp. 1747-1752, especially pp. 1747-1751 and Figures 1-5.
Lim et al. Affinity purification and enzymatic cleavage of inter-alpha inhibitor proteins using antibody and elastase immobilized on CIM monolithic disks. Journal of Chromatography A, 2005, vol. 1065, pp. 39-43.
EPO Form 1507.4, EP, Feb. 3, 2010, Supplementary European Search Report for 04810367.
Mizon, C. et al., “Human pre-[alpha]-inhibitor: Isolation from a by-product of industrial scale plasma fractionation and structural analysis of its H3 heavy chain”, Journal of Chromatography B: Biomedical Applications 19970509 NL, vol. 692, No. 2, May 9, 1997.
Michalski, Catherine et al: “Preparation and properties of a therapeutic inter-alpha trypsin inhibitor concentrate from human plasma”, Vox Sanguinis, vol. 67, No. 4, 1994, pp. 329-336.
Carrette, O. et al., “Purification and characterization of pig inter-alpha-inhibitor and its constitutive heavy chains”, CA, STN, ZENT. Biol. chem., Universitaetsklin, Frankfurt, Germany, vol. 1338, No. 1, Mar. 7, 1997, pp. 21-30.
Salier, J.P. et al., ; “Purification of the human serum inter-alpha-trypsin inhibitor by zinc chelate and hydrophobic interaction chromatographies”, Analytical Biochemistry, Academic Press, Inc. New York, vol. 109, No. 2, Dec. 1, 1980, pp. 273-283.
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