Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
2006-07-13
2009-11-17
Ford, Allison M (Department: 1651)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S028000, C435S004000, C435S014000, C435S029000, C435S034000, C436S001000, C436S815000, C422S001000
Reexamination Certificate
active
07618392
ABSTRACT:
Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. The methods and compositions employ modified bioburden testing and the detection of peptidoglycan. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.
REFERENCES:
patent: 4761237 (1988-08-01), Alexander et al.
patent: 4886789 (1989-12-01), Milner
patent: 4970152 (1990-11-01), Ashida et al.
patent: 5431496 (1995-07-01), Balteau et al.
patent: 6077836 (2000-06-01), Milner
patent: 6248726 (2001-06-01), Alsop et al.
patent: 6329011 (2001-12-01), Oita
patent: 6770148 (2004-08-01), Naggi et al.
patent: 2004/0121982 (2004-06-01), Martis et al.
Kanny G et al.: “Immunochemical Analysis of Peritoneal Dialysate in a Patient with Hypersensitivity to lcodextrin.” Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis, vol. 23, Jul. 2003, pp. 405-406.
Seow Ying-Ying T et al.: “Icodextrin-associated peritonitis among CAPD patients,” Nephrology Dialysis Transplantation, vol. 18, No. 9, Sep. 2003, pp. 1951-1952.
Toure Fatouma et al. “Icodextrin-induced peritonitis: Study of five cases and comparison with bacterial peritonitis,” Kidney International, vol. 65, No. 2, Feb. 2004, pp. 654-660.
Povlsen J. V. et al.: “Exposure to the Peptidoglycan Contaminant in Icodextrin May Cause Sensitization of the Patient Maintained on Peritoneal Dialysis.” Peritoneal Dialysis International, vol. 23, Sep. 2003, pp. 509-510.
Basile Carlo et al.: The impact of relapsing sterile icodextrin-associated pertionitis on pertioneal dialysis outcome.: Journal of Nephrology, vol. 16, May 2003, pp. 384-386.
Glorieux Griet et al.: “Specific Characteristics of Peritoneal leucocyte populations during sterile peritonitis associated with icodextrin CAPD fluids.” Nephrology Dialysis Transplantation, vol. 18, No. 8, Aug. 2003, pp. 1648-1653.
Malberti F et al.: “Sterile Peritonitis Associated with the Use of Icodextrin Solutions in Patients on Peritoneal Dialysis (PD)” Nephrology Dialysis Transplantation, vol. 17, No. Abstracts Supplement 1, 2002, p. 307, XP008048088 & XXXIX Congress of the European Renal Association and the European Dialysis and Transplant Association; Copenhagen, Denmark; Jul. 14-17, 2002.
Minors S et al.:“A Sensitive Chemiluminescence Based Immunoassay For Antibody To Staphylococcal Peptidoglycan” Journal of Immunological Methods, vol. 115, No. 1, 1988, pp. 119-125.
Extraneal letter dated May 22, 2002; 2 pages.
Wako Pure Chemical Industries, Ltd., Osaka, Japan, 6 pages, published prior to Feb. 27, 2004.
Vas, Stephen “Peritonitis,” Peritoneal Dialysis. 3rd ed. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1989:261-84.
Karanicolas et al., “Epidemic of aseptic peritonitis caused by endotoxin during chronic peritoneal dialysis,” N Engl J Med 1977;296:1336-7.
Pool et al., “Differentiation between endotoxin and non-endotoxin pyrogens in human albumin solutions using an ex vivo whole blood culture assay,” J Immunoassay 1999;20:79-89.
Smith et al., “Chemical peritonitis associated with intraperitoneal vancomycin,” Ann Pharm 1991;25:602-3.
Charney et al., “Chemical peritonitis secondary to intraperitoneal vancomycin,” Am J Kidney Dis 1991;17:76-9.
Benevent et al., “Dangers of administration of intraperitoneal amphotericin B in continuous ambulatory peritoneal dialysis,” Press Med 1984;13:1844.
Tuncer et al., “Chemical peritonitis associated with high dialysate acetaldehyde concentrations,” Nephrol Dial Transplant 2000;15:2037-40.
Gokal et al., “‘Eosinophilic’peritonitis in continuous ambulatory peritoneal dialysis (CAPD),” Clin Nephrol 1981;15:328-330.
Wilkie et al., “Icodextrin 7.5% dialysate solution (glucose polymer) in patients with ultrafiltration failure: extension of technique survival,” Perit Dial Int 1997;17:84-7.
Wolfson M., et al. “A randomized controlled trial to evaluate the efficacy and safety of icodextrin in peritoneal dialysis,” Am J Kidney Dis 2002;40:1055-65.
Mujais et al., “Evaluation and management of ultrafiltration problems in peritoneal dialysis,” Perit Dial Int 2000;20 (Suppl 4):S5-S21.
Pinerolo et al., “Recurrent sterile peritonitis at onset of treatment with icodextrin solution,” Perit Dial Int 1999;19:491-2.
Williams, Paul, “Timely initiation of dialysis,” Am J Kidney Dis 34:594-595, 1999.
Williams Paul, “Sterile/allergic peritonitis with icodextrin in CAPD patients,” Perit Dial Int 2002;22:89-90.
Foggensteiner et al., “Timely initiation of dialysis—single-exchange experiences in 39 patients starting peritoneal dialysis,” Perit Dial Int 2002;22:471-6.
Herring et al., “Peritoneal reaction to icodextrin in a female patient on CAPD,” Perit Dial Int 2001;21:323.
Del Rosso et al., “A new form of acute adverse reaction to icodextrin in peritoneal dialysis patient,” Nephrol Dial Transplant 2000;15:927-8.
Goffin et al., “Transient sterile chemical peritonitis in a CAPD patient using icodextrin,” Perit Dial Int 2002;22:90-1.
Tintillier et al., “Transient sterile chemical peritonitis with icodextrin: clinical presentation, prevalence, and literature review,” Perit Dial Int 2002;22:534-7.
Gokal et al., “Icodextrin-associated sterile peritonitis,” Perit Dial Int 2002;22:445-8.
Dinarello et al., “Human leukocyte pyrogen test for detection of pyrogenic material in growth hormone produced by recombinantEscherichia coli,” J Clin Microbiol 1984;20:323-9.
Poole et al., “Detection of pyrogen by cytokine release,” Lancet 1988;1(8577):130.
Tsuchiya et al. “Detection of peptidoglycan and B-glucan with silkworm larvae plasma test,” FEMS Immunol Medical Micrbiol 1996;15:129-34.
Ray et al. “Variability in LPS composition, antigenicity and reactogenicity of phase variants ofBordetella pertussis,” FEMS Microbiol Lett 1991;63:211-7.
Taktak et al., “Assay of pyrogens by interleukin-6 release from monocytic cell lines,” J Pharm Pharmacol 1991;43:578-82.
Fennrich et al. “Detection of endotoxins and other pyrogens using human whole blood,” Dev Biol Stand 1999;101:131-9.
Matsubara et al. “Alicyclobacillus acidiphilussp. Nov., a novel thermo-acidophilic, omega-alicyclic fatty acid-containing bacterium isolated from acidic beverages,” Int J Syst Evol Microbiol 2002; 52:1681-5.
Royce et al., “Endotoxin-like properties of an extract from a symbiotic, eukaryotic cholerella-like green algae,” J Endotoxin Res 1996;3:437-44.
Sriskandan et al., “Gram-positive sepsis,” Bacterial Sepsis and Septic Shock, Philadelphia: W. B. Saunders Company, 1999:397-412.
Garner et al., “Intravenous Injection of candida-derived mannan results in elevated tumor necrosis factor alpha levels in serum,” Infect Immun 1996;64:4561-6.
Schwab, John, “Phlogistic properties of peptidoglycan-polysaccharide polymers from cell walls of pathogenic and normal flora bacteria which colonize humans,” Infect Immun 1993;61:4535-9.
Henderson et al., “Bacterial modulins: a novel class of virulence factors which cause host tissue pathology by inducing cytokine synthesis,” Microbiol Rev 1996;60:316-41.
Nakagawa et al. “Evaluation of the in vitro pyrogen test system
Giertych Joseph A.
Kunzler Jacqueline A.
Martis Leo
Mongoven James W.
Owen, Jr. William F.
Baxter Healthcare S.A.
Baxter International Inc.
Ford Allison M
K&L Gates LLP
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