Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2003-12-22
2009-02-17
Navarro, Mark (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C514S012200, C424S184100, C424S234100, C424S247100
Reexamination Certificate
active
07491403
ABSTRACT:
Botulinumtoxin, a well know systemic poison, produces favorable therapeutic effect by virtue of regionally attaching to nerves within the myoneural junction and possibly other tissues in a target region of a particular tissue. The present invention provides compositions ofbotulinumtoxin and a sequestration agent that increase sequestration and delivery of thebotulinumtoxin to neural and associated tissues, as compared with available formulations ofbotulinumtoxins, and thereby produce a beneficial clinical effect. The sequestration agents of the present invention include proteins, lipids and carbohydrates. A preferred composition of the present invention comprises abotulinumtoxin and an albumin. The present invention also provides methods of treating neuromuscular diseases and pain using the disclosed compositions and methods of making the disclosed compositions.
REFERENCES:
patent: 4845042 (1989-07-01), Newman et al.
patent: 4861627 (1989-08-01), Mathiowitz et al.
patent: 5053005 (1991-10-01), Borodic
patent: 5069936 (1991-12-01), Yen et al.
patent: 5437291 (1995-08-01), Pasricha et al.
patent: 5512547 (1996-04-01), Johnson et al.
patent: 5562907 (1996-10-01), Arnon
patent: 5576468 (1996-11-01), Lubowitz
patent: 5696077 (1997-12-01), Johnson et al.
patent: 5756468 (1998-05-01), Johnson et al.
patent: 5846929 (1998-12-01), Johnson et al.
patent: 5939070 (1999-08-01), Johnson et al.
patent: 5965699 (1999-10-01), Schmidt et al.
patent: 5989545 (1999-11-01), Foster et al.
patent: 6051239 (2000-04-01), Simpson et al.
patent: 6087327 (2000-07-01), Pearce et al.
patent: 6100306 (2000-08-01), Li et al.
patent: 6203794 (2001-03-01), Dolly et al.
patent: 6210707 (2001-04-01), Papahadjopoulos et al.
patent: 6214602 (2001-04-01), Zdanovsky
patent: 6306423 (2001-10-01), Donovan et al.
patent: 6312706 (2001-11-01), Lai et al.
patent: 6312708 (2001-11-01), Donovan
patent: 6383509 (2002-05-01), Donovan et al.
patent: 6429189 (2002-08-01), Borodic
patent: 6447787 (2002-09-01), Gassner et al.
patent: 6545126 (2003-04-01), Johnson et al.
patent: 6579847 (2003-06-01), Unger
patent: 6585993 (2003-07-01), Donovan et al.
patent: 6620617 (2003-09-01), Mathiowitz et al.
patent: 7140371 (2006-11-01), Hanin et al.
patent: 7211261 (2007-05-01), Moyer et al.
patent: 2001/0043930 (2001-11-01), Aoki et al.
patent: 2002/0064536 (2002-05-01), Hunt
patent: 2002/0107199 (2002-08-01), Walker
patent: 2003/0086899 (2003-05-01), Jarari
patent: 2003/0108597 (2003-06-01), Chancellor et al.
patent: 2003/0118598 (2003-06-01), Hunt
patent: 2003/0138437 (2003-07-01), Hunt
patent: 2003/0138460 (2003-07-01), Hunt
patent: 2004/0037853 (2004-02-01), Borodic
patent: 2004/0071735 (2004-04-01), Marchini et al.
patent: 2004/0082540 (2004-04-01), Hermida Ochoa
patent: 2004/0126396 (2004-07-01), Aoki et al.
patent: 2004/0151741 (2004-08-01), Borodic
patent: 2004/0175400 (2004-09-01), Borodic
patent: 2004/0247606 (2004-12-01), Borodic et al.
patent: 2005/0031648 (2005-02-01), Brin et al.
patent: 2005/0112146 (2005-05-01), Graham
patent: 2005/0142150 (2005-06-01), Graham
patent: 2005/0208075 (2005-09-01), Borodic
patent: 2005/0208076 (2005-09-01), Hunt
patent: 2005/0214326 (2005-09-01), Hunt
patent: 2005/0238663 (2005-10-01), Hunt
patent: 2005/0238664 (2005-10-01), Hunt
patent: 2005/0238667 (2005-10-01), Hunt
patent: 2006/0147471 (2006-07-01), Borodic et al.
patent: 2006/0269575 (2006-11-01), Hunt
patent: 2007/0020294 (2007-01-01), Marchini et al.
patent: 2007/0026019 (2007-02-01), Hunt
patent: 0593176 (1993-09-01), None
patent: 94/00481 (1994-01-01), None
patent: WO 94/00481 (1994-01-01), None
patent: 96/39166 (1996-12-01), None
patent: WO 96/39166 (1996-12-01), None
patent: 97/35604 (1997-10-01), None
patent: WO 97/35604 (1997-10-01), None
patent: 00/24419 (2000-05-01), None
patent: 01/58472 (2001-08-01), None
patent: WO 01/58472 (2001-08-01), None
patent: 03/041724 (2003-05-01), None
patent: WO 2004/060384 (2004-07-01), None
Epinephrine package insert #58-6165, Abbott Laboratories, pp. 1-5, May 2000.
Botox package insert Allergan Pharmaceuticals, pp. 1-4.
Schmidt, James J. et al, Journal of Protein Chemistry, vol. 16(10, 1997, Endoproteinase activity of type A botulinum neurotoxin: substrate requirements and activation by serum albumin.
Gill, Michael, D, Microbiological Reviews, Mar. 1982, vol. 46(1) pp. 86-94, Bacterial toxins: a table of lethal amounts.
Goodnough, MC et al, Applied and Environmental Microbiology, Oct. 1992, vol. 58(10), pp. 3426-3428, Stabilization of botulinum toxin type A during lyophilization.
Schmidt, James J. et al, J. Pro. Chem., vol. 16(1), 1997, pp. 19-26.
Kalandakanond, Sarinee et al, 2001, The Journal of Pharmacology and Experimental Therapeutics, vol. 296(3), pp. 749-755.
Borodic, “Botulinum A Toxin for (expressionistic) ptosis overcorrection after frontalis sling,” Ophtalmic Plastic & Recostructive Surg. 8(2): 137-142, (1992).
Borodic et al. Botulinum A Toxin for the treatment of spasmodic torticollis, Dysphagia and Regional Toxin Spread. Head & Neck, 12: 392-398 (1990).
Nussgens et al. “Comparison of two botulinum-toxin preparations in the treatment of essential blepharospasm,” Graefes Arch Clin Exp Ophthalmol 235(4): 197-199 (1997).
Bigalke et al. Botulinum A Toxin: DYSPORT improvement of biological availability,: Exp. Neurol. 168(1): 162-170 (2001).
Lew et al. “Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia,” Neurology 49(3): 701-707 (1997).
Borodic et al “Botulinum Toxin: Clinical and Scientific Aspects.” Ophthalmology Clinics of North America 4: 491-503 (1991).
Borodic et al “Botulinum: a toxin for spasmodic torticollis, multiple vs. single point injections per muscle,” Head and Neck 14:33-37 (1992).
Ranoux et al “Respective potencies of Dysport and Botox: a double blind, randomized, crossover study in cervical dystonia,” J. Neuro. Neurosurg. Psychiatry 72: 459-462 (2002).
Holck et al “Comparison of High Dose Botulinum Toxin Type B to Botulinum Type A in the Treatment of Lateral Rhylids,” American Society of Ophthalmic Plastic and Reconstructive Surgeons Annual Meeting, Anaheim, CA Nov. 14, 2003).
Borodic et al “Botulinum B Toxin as an Alternative to Botulinum A Toxin, A Histologic study,” Ophthalmic Plastic and Reconstructive Surgery 9(3): 182-190 (1993).
Borodic et al. “Botulinum A Toxin for Treatment of Aberrant Facial Nerve Regeneration,” Plastic and Reconstructive Surger, 91(6): 1042-1045, 1993.
Troll, Gabriele, et al., “Diplopia After Cataract Surgery Using Forty Percent Lidocaine in the Absence of Wydase (Sodium Hyaluronidase)”, J. Clin. Anesth. vol. 11, Nov. 1999, pp. 615-616.
International Search Report and Written Opinion for PCT/US2006/015459 dated Mar. 1, 2007.
Borodic et al. “Botulinum toxin theraphy, immunologic resistance, and problems with available materials,” Neurology 1996; 46:26-29.
Schantz, Edward J. et al. Standardized Assay for Clostridium boutilum Toxins, Journal of the AOAC, vol. 61, No. 1, 1978.
Rollnik, J. et al., “Low-Dose Treatment of Cervical Dystonia, Blepharospasm and Facial Hemispasm with Albumin-Diluted Botulinum Toxin Type A Under EMG Guidance”, Eur Neurol 2000; 43:9-12.
Goodnough, M. et al., “Stabilization of Botulinum Toxin Type A during Lyophilization,” Allied and Environmental Microbiologu, Oct. 1992, p. 3426-3428.
Gassner, H. et al., “Addition of an Anesthetic Agent to Enhance the Predictability of the Effects of Botulinum Toxin Type A Injections: A Randomized Controlled Study”, Mayo Clin Proc, Jul. 2000, vol. 75.
Johnson, M. et al., “The Use of a Water-Soluble Carbodiimide as a Coupling Reagent in the Passive Hemagglutination Test”, The Journal of Immunology, vol. 97, No. 6.
Langhein, C. et al., “Antiobody response to bacterial antigens covalently bound to biodegradable polymerized serum albumin beads”, Journal of Applied Bacteriology 1987, 63, 443-448.
Internation
Botulinum Toxin Research Associates
Milbank, Tweed, Hadly & McLoy LLP
Navarro Mark
Portner Ginny
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