Sustained release formulation

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert

Reexamination Certificate

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C424S423000, C424S484000, C424S489000, C424S490000

Reexamination Certificate

active

08067020

ABSTRACT:
A composition comprises a protein, a polyol, and a metal. The protein is stabilized by the polyol and the metal, and is protected from denaturing when in contact with an organic solvent. The polyol may be a hydrocarbon containing two or more hydroxyl groups (—OH) bonded to carbon. The metal may be divalent.

REFERENCES:
patent: 4016273 (1977-04-01), Sieger et al.
patent: 4297344 (1981-10-01), Schwinn et al.
patent: 4938763 (1990-07-01), Dunn et al.
patent: 4975271 (1990-12-01), Dunn et al.
patent: 5077049 (1991-12-01), Dunn et al.
patent: 5096885 (1992-03-01), Pearlman et al.
patent: 5133981 (1992-07-01), Harkrader et al.
patent: 5242910 (1993-09-01), Damanj
patent: 5278201 (1994-01-01), Dunn et al.
patent: 5278202 (1994-01-01), Dunn et al.
patent: 5324519 (1994-06-01), Dunn et al.
patent: 5324520 (1994-06-01), Dunn et al.
patent: 5340849 (1994-08-01), Dunn et al.
patent: 5368859 (1994-11-01), Dunn et al.
patent: 5411951 (1995-05-01), Mitchell
patent: 5487897 (1996-01-01), Polson et al.
patent: 5556905 (1996-09-01), Frappier et al.
patent: 5589167 (1996-12-01), Cleland et al.
patent: 5591713 (1997-01-01), Igari et al.
patent: 5599552 (1997-02-01), Dunn et al.
patent: 5651986 (1997-07-01), Brem et al.
patent: 5665394 (1997-09-01), Igari et al.
patent: 5747058 (1998-05-01), Tipton et al.
patent: 5780044 (1998-07-01), Yewey et al.
patent: 5783205 (1998-07-01), Berggren et al.
patent: 5851229 (1998-12-01), Lentz et al.
patent: 5889035 (1999-03-01), Strupczewski et al.
patent: 5912015 (1999-06-01), Bernstein et al.
patent: 5945115 (1999-08-01), Dunn et al.
patent: 5968542 (1999-10-01), Tipton
patent: 5972370 (1999-10-01), Eckenhoff et al.
patent: 5981489 (1999-11-01), Stevenson et al.
patent: 6039977 (2000-03-01), Venkatraman et al.
patent: 6051259 (2000-04-01), Johnson et al.
patent: 6051558 (2000-04-01), Burns et al.
patent: 6066619 (2000-05-01), Stevenson et al.
patent: 6080429 (2000-06-01), Cleland et al.
patent: 6087324 (2000-07-01), Igari et al.
patent: 6110503 (2000-08-01), Rickey et al.
patent: 6113943 (2000-09-01), Okada et al.
patent: 6113947 (2000-09-01), Cleland et al.
patent: 6120789 (2000-09-01), Dunn
patent: 6124261 (2000-09-01), Stevenson et al.
patent: 6130200 (2000-10-01), Brodbeck et al.
patent: 6143314 (2000-11-01), Chandrashekar et al.
patent: 6146662 (2000-11-01), Jao et al.
patent: 6165508 (2000-12-01), Tracy et al.
patent: 6174547 (2001-01-01), Dong et al.
patent: 6190700 (2001-02-01), Okada et al.
patent: 6191107 (2001-02-01), Yamagata et al.
patent: 6197350 (2001-03-01), Yamagata et al.
patent: 6245806 (2001-06-01), Dombrowski et al.
patent: 6267958 (2001-07-01), Andya et al.
patent: 6328979 (2001-12-01), Yamashita et al.
patent: 6413536 (2002-07-01), Gibson et al.
patent: 6429296 (2002-08-01), Yamagata et al.
patent: 6719992 (2004-04-01), Jeng et al.
patent: 6992065 (2006-01-01), Okumu
patent: 7318931 (2008-01-01), Okumu et al.
patent: 7340226 (2008-03-01), Ben-Ayun et al.
patent: 2001/0002263 (2001-05-01), Yamagata et al.
patent: 2002/0001631 (2002-01-01), Okumu
patent: 2003/0045454 (2003-03-01), Okumu et al.
patent: 2325554 (1999-03-01), None
patent: 2 316 485 (1999-07-01), None
patent: 0 216 485 (1987-04-01), None
patent: 0216485 (1987-04-01), None
patent: 0216485 (1987-04-01), None
patent: 0351296 (1990-01-01), None
patent: 0389177 (1990-09-01), None
patent: 0 501 375 (1992-09-01), None
patent: 0484387 (1994-01-01), None
patent: 0633020 (1994-07-01), None
patent: 1060741 (2000-12-01), None
patent: 1274459 (2005-11-01), None
patent: 1 456 433 (1976-11-01), None
patent: 62-257990 (1987-11-01), None
patent: 2023866 (1990-01-01), None
patent: 7227282 (1995-08-01), None
patent: T H08-507064 (1996-07-01), None
patent: A H11-158200 (1999-06-01), None
patent: T H11-507278 (1999-06-01), None
patent: WO 89/03671 (1989-05-01), None
patent: WO 90/03768 (1990-04-01), None
patent: WO 91/05544 (1991-05-01), None
patent: WO 92/17200 (1992-10-01), None
patent: WO 92/17200 (1992-10-01), None
patent: WO 9217200 (1992-10-01), None
patent: WO 94/12158 (1994-06-01), None
patent: WO 94/19020 (1994-09-01), None
patent: WO 96/03116 (1996-02-01), None
patent: WO 96/18417 (1996-06-01), None
patent: WO 96/39995 (1996-12-01), None
patent: WO 96/40072 (1996-12-01), None
patent: WO 96/40073 (1996-12-01), None
patent: WO 96/40074 (1996-12-01), None
patent: WO 98/27962 (1998-07-01), None
patent: WO 98/27963 (1998-07-01), None
patent: WO 98/53837 (1998-12-01), None
patent: WO 99/33491 (1998-12-01), None
patent: WO 99/48479 (1999-09-01), None
patent: WO 00/38652 (2000-07-01), None
patent: WO 00/38652 (2000-07-01), None
patent: WO 0038652 (2000-07-01), None
patent: WO 00/78335 (2000-12-01), None
patent: WO 01/28524 (2001-04-01), None
patent: WO 01/78683 (2001-10-01), None
US 5,849,884, 12/1998, Woiszwillo et al. (withdrawn)
Bartus et al., “Sustained delivery of proteins for novel therapeutic products”, Science, United States, vol. 281, No. 5380, pp. 1161-1162, Aug. 21, 1998.
Bartus, R.T., et al.: “Sustained delivery of proteins for novel therapeutic agents.” Science. United States Aug. 21, 1998, vol. 281, No. 5380, pp. 1161-1162.
Smith, D.A., et al.: “A novel parenteral delivery system”, Pharm. Research, NY, NY, US, vol. 13, No. 3, 1996, p. 300 XP001041946, ISSN: 0724-8741.
Gray et al., “Cloning of Human Tumor Necrosis Factor (TNF) Receptor cDNA and Expression of Recombinant Soluble TNF-Binding Protein”, Proc.Natl. Acad. Sci. USA, 87, 7380-7384, (1990).
Kohno et al., “A Second Tumor Necrosis Factor Receptor Gene Product Can Shed a Naturally Occurring Tumor Necrosis Factor Inhibitor”, Proc.Natl. Acad. Sci. USA, 87, 8331-8335, (1990).
Arakawa et al., “Protein-Solvent Interactions in Pharmaceutical Formulations”,Pharmaceutical Research, 8, No. 3, 285-291, (1991).
Timasheff, S.N., “The Control of Protein Stability and Association by Weak Interactions with Water: How Do Solvents Affect These Processes?”Annu. Rev. Biophys. Biomol. Struct., 22, pp. 67-97, (1993).
Kita et al., “Contribution of the Surface Free Energy Perturbation to Protein-Solvent Interactions”,Biochemistry, 33, 15178-15189, (1994).
Timasheff, S.N., “Solvent Stabilization of Protein Structure”,Methods in Molecular Biology, 40, 253-269, (1995).
Johnson et al., “A Month-Long Effect From a Single Injection of Microencapsulated Human Growth Hormone”,Nature Medicine, 2, No. 7, 795-799, (1996).
Lin et al., “On the Role of Surface Tension in the Stabilization of Globular Proteins”,Protein Science, 5, 372-381, (1996).
Xie et al., “The Thermodynamic Mechanism of Protein Stabilization by Trehalose”,Biophysical Chemistry, 64, 25-43, (1997).
Maa at al., “Spray-Drying of Air-Liquid Interface Sensitive Recombinant Human Growth Hormone”,Journal of Pharmaceutical Sciences, 87, No. 2, 152-159, (1998).
Timasheff, S.N., “Control of Protein Stability and Reactions by Weakly Interacting Cosolvents: The Simplicity of the Complicated”,Advances in Protein Chemistry, 51, 355-432, (1998).
Sackett et al., “Multivalent Cations Depress Ligand Binding to Cell-Associated Insulin-Like Growth Factor Binding Protein-5 on Human Glioblastoma Cells”,Endocrinology, 139, No. 4, 1943-1951, (1998).
Lai et al., “Metal and RNA Binding Properties of the hdm2 Ring Finger Domain”,Biochemistry, 37, No. 48, 17005-17015, (1998).
Yang et al., “Effect of Zinc Binding and Precipitation on Structures of Recombinant Human Growth Hormone and Nerve Growth Factor”,Journal of Pharmaceutical Sciences, 89, No. 11, 1480-1485, (2000).
U.S. Appl. No. 60/214,168, filed Jun. 26, 2000.
Handbook of Chemistry and Physics, “Viscosity of Liquids”, David R. Lide, Editor, 72ndEdition, p. 6-159, 1991-1992.
“Crodesta Sugar Esters, Sucrose fatty acid esters”, Croda, Personal Care, pp. 1-4, Feb. 8, 2000.
International Search Report for PCT application No. PCT/US01/12909 dated Dec. 27, 2001.
Notice of Rejection for JP2003-506926 dated

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