Drug – bio-affecting and body treating compositions – Digestive system regulator containing solid synthetic...
Reexamination Certificate
2007-11-06
2007-11-06
Hartley, Michael G. (Department: 1618)
Drug, bio-affecting and body treating compositions
Digestive system regulator containing solid synthetic...
C424S400000, C514S892000
Reexamination Certificate
active
10277620
ABSTRACT:
Stimulant laxative in combination with an osmotic laxative produces safe and effective bowel and colon cleansing with a reduced volume of liquid input. Administering to a patient an oral stimulant laxative, such as bisacodyl, followed, after a biologically determined interval, by a reduced volume of a PEG in water solution cleanses the bowels and colon in preparation for diagnostic colonoscopy, without the profuse uncontrollable diarrhea that typically follows either ingestion of large volume isotonic ravages, or smaller volume hypertonic lavages.
REFERENCES:
patent: 5197950 (1993-03-01), Clayton
patent: 5616346 (1997-04-01), Aronchick
patent: 5670158 (1997-09-01), Davis et al.
patent: 5710183 (1998-01-01), Halow
patent: 5997906 (1999-12-01), Wood et al.
patent: 6162464 (2000-12-01), Jacob et al.
Brady et al. Effect of Bisacodyl on Gut Lavage Cleansing for Colonoscopy (1987; 19:34-38; Gastroenterology Service and General Surgery Dept, Wilford Hall USAF Medical Center, San Antonio, Texas, USA).
Adams et al., Bisacodyl Reduces the Volume or Polyethylene Glycol Solution Required for Bowel Preparation (1994; 37:229-234; Colorectal Unit, St George Hospital, Sydney, Australia).
Grundel et al., Improvements in Mechanical Bowel Preparation for Elective Colorectal Surgery (Dis Colon Rectum 1997; 40:1348-1352).
1998 (52ndedition) Physician Desk Reference at p. 1810 for DULCOLAX.
W. Adams, et al., “Bisacodyl Reduces the Volume of Polyethylene Glyco Solution Required for Bowel Preparation”, Colorectal Unit, Sst. George Hospital, Sydney, Australia, Dis Colon Rectum, Mar. 1994. p. 229-235.
B. Bokemeyer, “Koloskopievorbereitung”, Verdauungskrankheiten, 18: 17-24, 2000.
C.E. Brady, et al., “Effect of Bisacodyl on Gut Lavage Cleansing for Colonoscopy”, Analysis of Clinical Reseach, Analysis of Clinical Research 19:34-38, 1987.
W.K. Clarkston and O.J.Smith, “The Use of GoLYTELY and Dulcolax in Combination in Outpatient Colonoscopy”, J. Clinical Gastronenterology 17(2):146-8, 1993.
G.R. Davis, et al., “Development of a Lavage Solution Associated with Minimal Water and Electrolyte Absorption or Secretion”, Gastroenterology May 1980:78,991-995.
K. Grundel,et al., “Improvements in Mechanical Bowel Preparation for Elective Colorectal Surgery”, Dis Colon Rectum, Nov. 1997:40(11) :1348-1352.
E. Lind and J.N. Wiig, “Peroral emptying of the colon. A randomized comparison of 4 and 1.5 liter regimens”, Tidssky Nor Laegenforen, 110(11):1357-8, 1990.
V.K.Sharma, et al., Prospective, randomized, controlled comparison of the use of polyethylene glycol electrolyte lavage solution in four-liter versus two-liter volumes and pretreatment with either magnesium citrate or bisacodyl for colonoscopy preparation, Gastrointestinal Endoscopy 1998,47:2:167-171.
M.Vilien and M.Rytkonen, “Golytely Preparation for Colonoscopy: 1.5 Liters is Enough for Outpatients”, Endoscopy 22:168-170, 1990.
“Safety of Sodium Phosphates Oral Solutions” Sep. 17, 2001, Food and Drug Administration Science Background, U.S. Food & Drug Administration, Center for Drug Evaluation and Research. Web address: http;//www.fda.gov/cder/drug/safety/sodiumphosphate.htm.
InKine Pharmaceutical Company, Inc. package insert 2000, Visicol Tablets.
Prescribing information from Fleet “Fleet Phospho-soda OTC, An oral saline laxative”, Web address: http//www.phosphosoda.com/HCP/HCPPDR.asp, Feb. 18, 2003.
Ziegenhagen, et al., “Senna vs. Bisacodyl in Addition to Golytely Lavage for Colonoscopy Preparation—a Prospective Randomixed Trial,”Z Gastroenterol, (1992), pp. 17-19, vol. 30.
Toledo, et al., “Review Article: Colon Cleansing Preparation for Gastrointestinal Procedures,”Aliment Pharmacol Ther, (2001), pp. 605-611, vol. 15.
Description of Clinical Trials, Jul. 2002.
Chan, et al., “Use of Oral Sodium Phosphate Colonic Lavage Solution by Canadian Colonscopists: Pitfalls and Complications”,Canadian Journal of Gastroenterology, vol. 11(4), pp. 334-338 (1997).
Ahmed, et al., “Oral Sodium Phosphate Catharsis and Acute Renal Failure”,American Journal of Gastroenterology, vol. 91(6), pp. 1261-1262 (1996).
DiPalma, et al., “Biochemical Effects of Oral Sodium Phosphate”,Digestive Diseases and Sciences, vol. 41(4), pp. 749-753 (1996).
Kolts, et al., “A Comparison of the Effectiveness and Patient Tolerance of Oral Sodium Phosphate, Castor Oil, and Standard Electrolyte Lavage for Colonoscopy or Sigmoidoscopy Preparation”,American Journal of Gastroenterology, vol. 88(8), pp. 1218-1223 (1993).
Vanner, et al., “A Randomized Prospective Trial Comparing Oral Sodium Phosphate with Standard Polyethylene glycol-based lavage solution (Golytely) in the Preparation of Patients for Colonoscopy”,American Journal of Gastroenterology, vol. 85(4), pp. 422-427 (1990).
Cleveland Mark V B.
Dennett, Jr. Edmund V.
Pelham Russell W.
Raleigh, Jr. Robert M.
Braintree Laboratories Inc.
Fubara Blessing
Hartley Michael G.
Wilmer Cutler Pickering Hale and Dorr LLP
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