Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...
Reexamination Certificate
2005-01-24
2008-10-28
Duffy, Patricia A. (Department: 1645)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
C424S141100, C424S142100, C424S150100, C424S164100, C530S387100, C530S388100, C530S388150, C530S388400, C530S389100, C530S389500
Reexamination Certificate
active
07442373
ABSTRACT:
A highly efficient method for generating human antibodies using recall technology is provided. In one aspect, human antibodies which are specific to the anthrax toxin are provided. In one aspect, human peripheral blood cells that have been pre-exposed to anthrax toxin are used in the SCID mouse model. This method results in high human antibody titers which are primarily of the IgG isotype and which contain antibodies of high specificity and affinity to desired antigens. The antibodies generated by this method can be used therapeutically and prophylactically for preventing or treating mammals exposed to anthrax. Thus, in one embodiment, a prophylactic or therapeutic agent used to counter the effects of anthrax toxin, released as a mechanism of bioterrorism, is provided. In one embodiment, a formulation and method for preventing and/or treating anthrax infection comprising a binding agent that prevents the assembly of the PA63 heptamer is also provided. Methods for diagnosis and methods to determine anthrax contamination are also described.
REFERENCES:
patent: 5677274 (1997-10-01), Leppla et al.
patent: 5811524 (1998-09-01), Brams et al.
patent: 5958765 (1999-09-01), Brams et al.
patent: 6329156 (2001-12-01), Cirino et al.
patent: 6387665 (2002-05-01), Ivins et al.
patent: 6413771 (2002-07-01), Brams et al.
patent: 6537809 (2003-03-01), Brams et al.
patent: 6770479 (2004-08-01), Lee et al.
patent: 6828110 (2004-12-01), Lee et al.
patent: 6916474 (2005-07-01), Harvey et al.
patent: 7261900 (2007-08-01), Leppla et al.
patent: 2003/0108556 (2003-06-01), Mekalanos et al.
patent: 2003/0118591 (2003-06-01), Levy
patent: 2003/0143636 (2003-07-01), Simonson et al.
patent: 2003/0202989 (2003-10-01), Collier et al.
patent: 2004/0009178 (2004-01-01), Bowdish et al.
patent: 2004/0009945 (2004-01-01), Lee et al.
patent: 2004/0014707 (2004-01-01), Cirino et al.
patent: 2004/0076631 (2004-04-01), Brams et al.
patent: 2004/0076638 (2004-04-01), Shiloach et al.
patent: 2004/0166120 (2004-08-01), Thomas et al.
patent: 2004/0171121 (2004-09-01), Leppla et al.
patent: 2004/0235075 (2004-11-01), Collum et al.
patent: 2005/0054038 (2005-03-01), Bhatnagar et al.
patent: 2005/0063986 (2005-03-01), Bhatnagar et al.
patent: 2005/0287149 (2005-12-01), Keler et al.
patent: 2006/0258842 (2006-11-01), Groen et al.
patent: WO 03/076568 (2003-09-01), None
patent: WO 2005/120567 (2005-12-01), None
Bendig (Methods: A Companion to Methods in Enzymology 1995; 8:83-93).
Sawada-Hirai et al (Journal of Immune Based Therapies and Vaccines 2:5, May 12, 2004).
Cirino et al (Infection and Immunity, 67(6):2957-2963, Jun. 1999).
Little et al (Infection and Immunity, 65:125171-5175, Dec. 1997).
Choi et al (Abstracts of the Intersceince Conference on Antimicrobial Agents and Chemotherapy; 43:277, Sep. 14-17, 2003).
Bohannon (Science 300:414-415, Apr. 18, 2003).
Bull et al (Science, 297:201-202, Jul. 12, 2002).
Lacy, DB et al. “Crystal structure of the von Willebrand factor A domain of human capillary morphogenesis protein 2: an anthrax toxin receptor.”Proc Natl Acad Sci USAApr. 27, 2004; 101(17):6367-72. Epub Apr. 12, 2004.
Wigelsworth, DJ et al. “Binding Stoichiometry and Kinetics of the Interaction of a Human Anthrax Toxin Receptor, CMG2, with Protective Antigen.”J. Biol. Chem., vol. 279, Issue 22 (May 28, 2004): 23349-23356.
Jonah, G. et al. “Antitoxins: Novel Strategies to Target Agents of Bioterrorism.”Microbiology, vol. 2, 721-726, Sep. 2004.
Sellman, Bret R. et al. “Dominant-Negative Mutants of a Toxin Subunit: An Approach to Therapy of Anthrax.”Science, vol. 292 (Apr. 27, 2001): 695-697.
Mourez, Michael et al. “Designing a polyvalent inhibitor of anthrax toxin.”Nature Biotechnology, vol. 19 (Oct. 2001): 958-961.
“New Approaches Combat Anthrax's Deadly Effects” Respiratoryreviews.com. Zucker, Mimi, Ph.D. Apr. 4, 2005.
“Mechanism of Anthrax Toxins”The Biotech Journal. Nov./Dec. 2003. <www.biotechjournal.com>.
Rodney Boyer. “Anthrax”Interactive Concepts in Biochemistry© 2002, John Wiley & Sons Publishers, Inc. <http://www.wiley.com/legacy/college/boyer/0470003790/cutting—edge/anthrax/anthrax.htm> Dated visited Jan. 7, 2005.
Mosier, Donald E. et al. “Transfer of a functional human immune system to mice with severe combined immunodeficiency.”Nature, vol. 335 (Sep. 15, 1988): 256-259.
Maynard, Jennifer A. et al. “ Protection against anthrax toxin by recombinant antibody fragments correlates with antigen affinity.”Nature Biotechnology. vol. 20 (2002): 597-601.
Turnbull, Peter C. B. et al. “Development of Antibodies to Protective Antigen and Lethal Factor Components of Anthrax Toxin in Humans and Guinea Pigs and Their Relevance to Protective immunity.”Infection and Immunity. vol. 52, No. 2 (May 1986): 356-363.
Welkos, SL et al. “Sequence and analysis of the DNA encoding protective antigen ofBacillus anthracix.” Gene. vol. 69, No. 2 (1988): 287-300. (Abstract).
Novak, Jeanne M. Novak et al. “Functional Characterization of Protease-treatedBacillus anthracisProtective Antigen.”The Journal of Biological Chemistry. vol. 267, No. 24 (1992): 17186-17193.
Wild et al. “Human antibodies from immunized donors are protective against anthrax toxin in vivo.”Nature Biotechnology. vol. 21, No. 11 (Oct. 2003): 1305-1306.
Cirino et al. “Disruption of Anthrax Toxin Binding with the Use of Human Antibodies and Competitive Inhibitors.”Infection and Immunity. vol. 67, No. (Jun. 1999): 2957-2963.
Zolla-Panzer, S. Human Monoclonal Antitoxin to Anthrax Protective Antigen. NLM Doc. No. CRISP/2002/AI53306-01. Pub. Year (as listed): 2002.
Morrow, P.R. “Diverse mix of Human MoAbs to treat Anthrax exposure.” NLM Doc. No. CRISP/2002/AI052901-01A1. Pub. Year (as listed): 2003.
Karginov et al. (FEMS Immunology and Medical Microbiologyl; 40:71-74, 2004—first published on-line Nov. 7, 2003).
Casadevall (Emerging Infectious Diseases, 8(8):833-841, Aug. 2002).
Abbas et al. Cellular and Molecular Immunology, W.B. Saunders Co., 1991, pp. 50-57, 75-89.
Binder et al. (Comp. Immun. Microbiol. Infect. Dis. 26:401-421, 2003).
Physicians' Desk Reference (Edition 55, 2001, pp. 816-818 and 871-876).
Brams et al. Antigen-Specific IgG Responses for Naïve Human Splenocytes: In Vitro Priming Followed by Antigen Boost in the SCID Mouse. The Journal of Immunology. 1998, vol. 160, pp. 2051-2058 (entire document).
Written Opinion of the International Searching Authority of PCT Application No. PCT/US05/01574, filed Jan. 21, 2005.
Little, et al. “Production and Characterization of Monoclonal Antibodies to the Protective Antigen Component ofBacillus anthracisToxin.” infection and Immunity, Jul. 1988. 56:7, 1807-1813.
Peterson, et al. “Human Monoclonal Antibody AVP-21D9 to Protective Antigen Reduces Dissemination of theBacillus anthracisAmes Strain from the Lungs in a Rabbit Model.” Infection and Immunity, Jul. 2007. 75:7, 3414-3424.
Peterson, et al. “Human Monoclonal Anti-Protective Antigen Antibody Completely Protects Rabbits and Is Synergistic with Ciprofloxacin in Protecting Mice and Guinea Pigs against Inhalation Anthrax.” Infection and Immunity, Feb. 2006. 74:2, 1016-1024.
Stiehm, et al. “Passive Immunization” Textbook of Pediatric Infectious Diseases 4th Ed. vol. 2, Philadelphia: WB Saunders Company, pp. 3769-3802, 1998.
Jiang Ivy
Kang Angray S.
Morrow, legal representative Jeanne
Sawada Ritsuko
Scholz Wolfgang
Duffy Patricia A.
Emergent Product Development Gaithersburg Inc.
Sterne Kessler Goldstein & Fox P.L.L.C.
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