Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...
Reexamination Certificate
2005-08-23
2005-08-23
Chan, Christina (Department: 1644)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
C424S178100, C530S350000, C530S389100, C530S391100
Reexamination Certificate
active
06932967
ABSTRACT:
Pooled human plasma is processed by cold ethanol fractionation to produce purified immunoglobulin G antibodies for intravenous administration. Immunoglobulin A is an unwanted by-product since intravenous administration of immunoglobulin A-containing immunoglobulin G can cause life-threatening anaphylaxis in some people. The present invention is the aerosol administration, by metered dose inhaler or nebulizer, of by-product immunoglobulin A for the prevention or treatment of diseases including immunodeficiencies and infections. Antigen-specific monoclonal immunoglobulin A may be used. Immunoglobulin A from any of the aforementioned sources may then be coupled with recombinant J chain, and may then be additionally coupled with recombinant secretory component in order to render the immunoglobulin A more physiologically active. Immunoglobulin A, with or without J chain and secretory component, is then administered by aerosol inhalation.
REFERENCES:
patent: 4482483 (1984-11-01), Curry et al.
patent: 4695068 (1987-09-01), Kawamoto et al.
patent: 5210183 (1993-05-01), Lindahl et al.
patent: 5258177 (1993-11-01), Uemura et al.
patent: 5670626 (1997-09-01), Chang
patent: 5808000 (1998-09-01), Mannhalter et al.
patent: 6019968 (2000-02-01), Platz et al.
patent: 6063905 (2000-05-01), Capra et al.
patent: 6124132 (2000-09-01), Blake
patent: 6165463 (2000-12-01), Platz et al.
patent: 4122784 (1993-01-01), None
patent: 1 068 871 (2001-01-01), None
Rindisbacher et al, J Biol Chem 270(3): 14220-28; 1995.
Zikan et al, Mol Immunol 23(5): 541-4, May 1986, Abstract.
Jones et al, Biochim Biophys Acta 429(1): 265-74, Dec. 1998.
Johansen et al, Eur J Immunol 29: 1701-1708, 1999.
Boros et al, Immunologiae Hungaricae 17: 57-61, 1974.
Lindh et al, Eur J Biochem 62(2): 263-70, 1976.
Symersky et al, Molecular Immunol 37: 133-140, Feb.-Mar. 2000.
Berzofsky, J.A., Berkower, I.J., Epstein, S.L., Monoclonal Antibodies in Chapter 12, Antigen-Antibody Interactions and Monoclonal Antibodies, pp. 455-465 in Fundamental Immunology, Third Edition, WE Paul (ed), Raven Press, NY 1993.
Cohn, E.J., Strong, L.E., Hughes, W.L., Jr., Mulford, D.J., Ashworth, J.N., Melin, M., Taylor, H.L., Preparation and Properties of Serum and Plasma Proteins IV. A System for the Separation into Fractions of the Protein and Lipoprotein Components of Biological Tissues and Fluids, J. Am Chem Soc. 1946; 68;459-475.
Corthesy, B., Recombinent Secretory IgA for Immune Intervention Against Mucosal Pathogens, Biochem Soc Trans. 1997, 25;471-475.
Crottet, P., Cottet, S., Corthesy, B., Expression, Purification and Biochemical Characterization of Recombinant Murine Secretory Component, A Novel Tool in Mucosal Immunology, Biochem J 1999, 341;299-306.
Fahy, J.V., Cockcroft, D.W., Boulet, L.P., Wong, H.H., Deschesnes, F., David, E.E., Ruppel, J., Su, J.Q., Adelman, D.C., Effect of Aerosolized Anti-IgE (E25) on Airway Responses to Inhaled Allergen in Asthmatic Subjects. Am J Respir Crit Care Med 1999, 160:1023-1027.
Fruchtman, M.H., Mauceri, A.A., Wigley, F.M., Waldman, R.H., Aerosol Administration of Human Gamma Globulin as Prophylaxis against Influenza Virus Challenge. Clin Med 1972 (Sep.), 79:17-20.
Giraudi, V., Riganti, C., Torales, M.R., Sedola, H., Gaddi, E., Upper Respiratory Infections in Children, Response to Endonasal Administration of IGA. Int J Prediatr Otorhinolarynol, 1997; 39:103-110.
Heikkinen, T., Ruohola, A., Ruuskanen, O., Waris, M., Uhari, M., Hammarstrom, L., Intranasally Administered Immunoglobulin for the Prevention of Rhinitis in Children; Pediatr Infect Dis J 1998; 17:367-372.
Hemmingsson, M., Hammarstrom, L., Nasal Administration of Immunoglobulin as Effective Prophylaxis Against Infections in Elite Cross-Country Skiers. Scand J Infect Dis 1993; 25:73-75.
Johansen, F-E., Norderhaug, I. N., Roe, M., Sandlie, I. and Brandtzaeg, P., Recombinant expression of polymeric IgA: incorporation of J chain and secretory component of human origin, Eur. J. Immunol. 1999; 29: 1701-1708.
Kohler, G., Milstein, C., Continuous Cultures of Fused Cells Secreting Antibody of Predetermined Specificity, Nature 1975;256;495-497.
Lindberg, K., Berglund, B., Effect of Treatment with Nasal IgA on the Incidence of Infectious Disease in World-Class Canoeists. Int J Sports Med 1996; 17:235-238.
Lullau, E., Heyse, S., Vogel, H., Marison, I., von Stockar, U., Kraehanbuhl, J-P., Corthesy, B., Antigen Binding Properties of Purified Immunoglulin A Antibodies, J Biol Chem 1996; 271:16300-16309.
Mazanec, M.B., Lamm, M.E., Lyn, D., Portner, A., Nedrud, J.G., Comparison of IgA versus IgG Monoclonal Antibodies for Passive Immunization of the Murine Respiratory Tract. Virus Res 1992; 23:1-12.
Mazanec, M.B., Nedrud, J.G., Lamm, M.E., Immunoglobulin A Monoclonal Antibodies Protect against Sendai Virus. J. Virol. 1987; 61:2624-2626.
Oncley, J.L., Melin, M., Richert, D.A., Cameron, J.W., Gross, P.M., Jr., The Separation of the Antibodies, Isoagglutinins, Prothrombin, Plasminogen and β1-Lipoprotein into Subfractions of Human Plasma. J Am Chem Soc 1949;71:541-550.
Outlaw, M.C., Dimmock, N.J., Mechanisms of Neutralization of Influenza Virus on mouse Tracheal Ephithelial Cells by Mouse Monoclonal Polymeric IgA and Polyclonal IgM directed against the Viral Haemaglutinin. J Gen Virol 1990;71:69-76.
Rimensberger, P.C., Schaad, U.B., Clinical Experience with Aerosolized Immunoglobulin Treatment of Respiratory Syncytial Virus Infection in Infants. Pediatr Infect Dis J 1994;13:328-330.
Rindisbacher, L., Cottet, S., Wittek, R., Kraehenbuhl, J.P., Corthesy, B., Production of Human Secretory Component with Dimeric IgA Binding Capacity Using Viral Expression Systems. J Biol Chem 1995;270:14220-14228.
Strong, L.E., Blood Fractionation, pp. 576-602 in vol. 3, Kirk-Othmer Encyclopedia of Chemical Technology. Second Edition, H.F. Mark, J.J. McKetta, D.F. Othmer (eds), Interscience Publishers, NY 1963.
Symersky, J., Novak, J., McPherson, D.T. DeLucas, L., Mestecky, J., Expression of the Recombinant Human Immunoglobulin J Chain inEscheria coli. Mol Immunol 2000, 37:133-140.
Tamara, S., Funato, H., Hirabayashi, K., Kikuta, K., Suzuki, Y., Nagamine, T., Aizawa, C., Kurata, T., Cross-Protection against Influenza A Virus Infection by Passively Transferred Respiratory Tract IgA Antibodies to different Haemagglutinin Molecules. Eur J Immunol 1991;21:1337-1344.
Tamura, S., Funato, H., Hirabayashi, K., Kikuta, K., Suzuki, Y., Nagamine, T., Aizawa, C., Nakagawa, M., Kurata, T., Functional Role of Respiratory Tract Haemagglutinin-Specific IgA Antibodies in Protection against Influenza. Vaccine 1990;8:479-485.
Taylor, H. P., Dimmock, N.J., Mechanism of Neutralization of Influenza Virus by Secretory IgA is Different from that of Monomeric IgA or IgG. J Exp Med 1985;161:198-209.
Weltzin, R., Hsu, S.A., Mittler, E.S., Georgakopoulas, K., Monath, T.P., Intranasal Monoclonal Immunoglobulin A against Respiratory Synctial Virus Protects against Upper and Lower Respiratory Tract Infections in Mice. Antimicrob Agents Chemother. 1994;38:2785-2791.
Weltzin, R., Traina-Dorge, V., Soike, K., Zhang, J.Y., Mack, P., Soman, G., Drabik, G., Monath, T.P., Intranasal Monoclonal IgA Antibody against Respiratory Syncytial Virus Protects Rhesus Monkeys against Upper and Lower Respiratory Tract Infection. J Infect Dis 1996;174:256-261.
Wolff, R.K., Niven, R.W., Generation of Aerosolized Drugs. J Aerosol Med 1994;7:89-106.
Bezares et al. “Prevencion de infecctiones en pacientes con sindromes linfoproliferativos y mieloma por nebulizacion de un concentrado de IgA” Sangre 1997; 42(3):219-222.
Sanchez Avaios et al. “Nebulizaciones con IgA humana en pacientes con hipogammaglobullnemia e infecciones de las vias aeras secundararias a enfermedades linfoproliferativas” Medicina (Buenos Aires) 1995; 55(6):727-729.
Leibel et al. “Method for the isolation of biologically active monomeric immunoglobulin A from a plasma fraction” Journal of chromatography B, 678 (1996) 173-180.
Document bibliography and abstract, Patent WO 0103727.
Document bibliography and abstract, Patent CS242310.
Chan Christina
Gifford, Krass, Groh Sprinkle, Anderson & Citkowski, P.C.
Huynh Phuong
LandOfFree
Human medical treatment by aerosol inhalation of... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Human medical treatment by aerosol inhalation of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Human medical treatment by aerosol inhalation of... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3459362