Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Structurally-modified antibody – immunoglobulin – or fragment...
Reexamination Certificate
2002-07-25
2008-07-22
Ewoldt, G. R. (Department: 1644)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Structurally-modified antibody, immunoglobulin, or fragment...
C424S145100, C424S158100, C530S387300, C530S388240
Reexamination Certificate
active
07402313
ABSTRACT:
A method of controlling preeclampsia includes the steps of providing a supply of digoxin immune Fab (ovine), calculating an appropriate dosage of the digoxin immune Fab (ovine) based on a patient's weight and using an assumed endogenous digitalis-like factor level, administering the appropriate dosage as an intravenous bolus, and repeating the administration of the appropriate dosage on a fixed schedule.
REFERENCES:
patent: 4767720 (1988-08-01), Lingwood
patent: 5770376 (1998-06-01), Bagrov
patent: 6290657 (2001-09-01), Adams et al.
patent: 6699676 (2004-03-01), Orlov et al.
patent: 6835715 (2004-12-01), Valdes, Jr. et al.
patent: 2004/0133929 (2004-07-01), Davisson
patent: 2005/0123999 (2005-06-01), Valdes, Jr. et al.
patent: 2006/0263891 (2006-11-01), Puschett
patent: WO 2004/071273 (2004-08-01), None
patent: WO 2004/071273 (2004-08-01), None
patent: WO 2004/071273 (2004-08-01), None
Adair et al. Elevated endotoxin-like factor complicating a multifetal second trimester pregnancy. 1996, Am. J. Nephrol. 16:529-531.
The Merck Manual of Diagnosis and Therapy, 17th edition, 1999, Beers and Berkow, editors, Merck Research Laboratories, p. 2057-2058.
Product Information Insert for Digibind (GlaxoSmithKline) Digoxin Immune FAB (Ovine) 2001, p. 1-8.
Webster's New World Dictionary, third college edition, editor V. Neufeldt, Simon and Schuster, Inc., 1988, p. 68.
Adair, D. et al.: Effects of Fab Digozin-Specific Antibody (Fab) On Mean Arterial Pressure (MAP) in Severe Preclampsia (PE) AJH 1997, pp. 10:11A-12A.
Goodlin, R.C.: Will Treatment With Digoxn Antibody Benefit Pregnant Patients With Toxemia and Elevated Digoxin Like Factor? Medical Hypotheses, 1987, vol. 24(1), pp. 107-110.
Adair, D. et al.: Elevated Endoxin-Like Factor Complicating a Multifetal Second Trimester Pregnancy: Treatment Digoxin-Binding Immunoglobulin; Am. J. Nephrol 1996, vol. 16, pp. 529-531.
Goodlin, R.C.: Antidigoxin Antibodies in Eclampsia, The New England Journal of Medicine, 1988, pp. 518-519.
Miyagi H, Higuchi M, Nakayama M, et al. Ouabain-Like Na+,K=-ATPase Inhibitory Activity of a Plasma Extract in Normal Pregnancy and Pregnancy Induced Hypertension, Japan J Pharmacol 1991: 57:571-581.
Beyers AD, Odendaal HJ, Spruyt LL, Parkin DP. The Possible Role of Endogenous Digitalis-Like Substance in the Causation of Pre-Eclampsia, SA Medical Journal 1984: 65:883-885.
Lopatin DA Ailamazian EK, Dmitrieva RI, et al. Circulating Bufodienolide and Cardenolide Sodium Pump Inhibitors in Preeclampsia, J Hypertens 1999: 17:1179-1187.
Craig RH, Knight A, Valdes R. Binding of Endogenous Digoxin-Like Immunoreactive Factor to Serum Proteins During Normal and Hypertensive Pregnancy, J Clin Immunoassay 1991: 14:245-250.
Ghione S, Balzan S, Decollogne S, et al. Endogenous Digitalis-Like Activity in the Newborn. J Cardiovasc Pharmacol 1993; 22(Suppl. 2):25-28.
Adair D, Wang Y, Lewis D, et al. Digoxin Binding Fragment Immunoglobulin Antibody (Digibind DFAB) Inhibits Thromboxane Production in Preeclamptic Placentas, Hypertension in Pregnancy 2000: 19(1):57 (Abstract).
Product Information Insert for DigiFab, Nov. 2001.
protherics.com/products/antibody.htm, Jan. 21, 2003.
Clinical Product Monograph for DigiFab final release, Feb. 4, 2002.
Product Information for Digiband, Aug. 2001.
Crossey, Michael J et al.; “Effects of Digoxin-Like Immunoreactive Substance and Digoxin FAB Antibodies on the New Digoxin Microparticle Enzyme Immunoassay”, Therapeutic Drug Monitoring, vol. 19, No. 2, 1997, pp. 185-190.
Krep Hennig et al.; “Volume Sensitive Hypertension and the Digoxin-Like Factor: Reversal by a FAB Directed Against Digoxin in DOCA-Salt Hypertensive Rats.” American Journal of Hypertension, vol. 8, No. 9, 1995, pp. 921-927.
Ghione S. et al.; “Endogenous Digitalis-Like Activity in the Newborn” Journal of Cardiovascular Pharmacology, vol. 22, No. Suppl. 2, 1993, pp. S25-S28.
Goto A et al.; “Ouabain-Like Factor.” Current Opinion in Nephrology and Hypertension, United States Mar. 1998, vol. 7, No. 2, pp. 189-196.
Baily Benoit.; “Are There Teratognic Risks Assoicated With Antidotes Used in the Acute Management of Poisoned Pregnant Women?”, Birth Defects Research, vol. 67, No. 2, Feb. 2003, pp. 133-140.
M. Johansson et al., “Activity and Protein Expression of Na+/K+ ATPase Are Reduced in Microvillous Syncytiotrophoblast Plasma Membranes Isolated from Pregnancies Complicated by Intrauterine Growth Restriction”, J. Clin. Endocrinol Metab., Jun. 2003, 88, (6), pp. 2831-2837.
Aizman, O. et al., “Ouabain, a steroid hormone that signals with slow calcium oscillations”,PNAS, 2001, vol. 98, No. 23, pp. 13420-13424.
Amorium, M.M.R., et al., “Corticosteriod therapy for prevention of respiratory distress syndrome in severe preeclampsia”,Am. J. Obstet. Gyngol., 1999, vol. 180, No. 5, pp. 1283-1288.
Bagrov, A. Y., et al., “Characterization of a Urinary Bufodienolide Na+, K+-ATPase Inhibitor in Patients After Acute Myocardial Infarction”,Hypertension, 1998, vol. 31, pp. 1097-1103.
Ball, W. J. Jr. et al., “Isolation and Characterization of Human Monoclonal Antibodies to Digoxin”,The Journal of Immunology, 1999, vol. 163, pp. 2291-2298.
Butler, V. et al., “Digoxin-Specific Antibodies”,Proc. Natl. Acad. Sci. USA(Physiology), 1967, vol. 57, pp. 71-78.
Dasgupta, A. et al, “Monitoring Free Digoxin Instead of Total Digoxin in Patients with Congestive Heart Failure and High Concentrations of Dogoxin-like Immunoreactive Substances”,Clin. Chem., 1990, vol. 36, No. 12, pp. 2121-2123.
“Deaths Associated with a Purported Aphrodisiac—New York City, Feb. 1993-May 1995”,Morbidity and Mortality Weekly Report, 1995, vol. 44, No. 46, pp. 853-861.
Dimitrieva, R.I. et al., “Cardiotonic Steroids: Potential Endogenous Sodium Pump Ligands with Diverse Function”,Exp. Biol. Med., 2002, vol. 227, No. 8, pp. 561-569.
Doris, P.A. et al., “Endogenous Sodium Pump Inhibitors and Blood Pressure Regulation: An Update on Recent Progress”,Proc. Soc. Exp. Biol. Med., 1998, vol. 218, pp. 156-167.
El-Masri, M.A. et al., “Human Adrenal Cells in Culture Produce Both Ouabain-like and Dihydrooubain-like Factors”,Clin. Chem., 2002, vol. 48, No. 10, pp. 1720-1730.
Eddleston, M. et al., “Management of acute yellow oleander poisoning”,Q. J. Med., 1999, vol. 92, pp. 483-485.
Fedorova, O.V. et al., “Marinobufagenin, and Endogenous α-1 Sodium Pump Ligand, in Hypertensive Dahl Salt-Sensitive Rats”,Hypertension, 2001, vol. 37 part 2, pp. 462-466.
Fedorova, O.V. et al., “Endogenous Na,K Pump Ligands Are Differentially Regulated During Acute NaCl Loading of Dhal Rats”,Circulation, 2000, vol. 102, pp. 3009-3014.
Federova, O.V. et al., “Endogenous Ligand of α1Sodium Pump, Marinobufagenin, Is a Novel Mediator of Sodium Chloride-Dependent Hypertension”,Circulation, 2002, vol. 105, pp. 1122-1127.
Federova, O.V. et al., “Antibody to marinobufagenin lowers blood pressure in pregnant rates on a high NaC1 intake”,J. Hypertension, 2005, vol. 00, No. 00, pp. 1-9.
Gonzalez, A. R. et al., “Digoxin-like immunoreactive substance in pregnancy”,AM. J. Obstet. Gynecol., 1987, vol. 157, pp. 660-664.
Goto, A. et al., “Putative Roles of Ouabainlike Compound in Hypertension: Revisited”,Hypertens. Res., 2000, Supp. 23, pp. S7-S13.
Gottlieb, S.S. et al., “Elevated Concentration of Endogenous Ouabain in Patients with Congestive Heart Failure”,Circulation, 1992, vol. 86, No. 2, pp. 420-425.
Di Grande, A. et al., “Release of a Substance from the Human Placenta Having Digoxin-Like Immunoreactivity”,Clin. Exp. Pharmacol. Physiol., 1993, vol. 20, pp. 603-607.
Graves, S.W. et al., “An endogenous Ouabain-Like Factor Associated with Hypertensive Pregnant Women”,J. Clin. Endocrinol. Metabl., 1984, vol. 59, pp. 1070-1074.
Gusdon, J. P. Jr. et al., “A digoxin-like
Ewoldt G. R.
Hunton & Williams LLP
Szperka Michael
LandOfFree
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