Chemistry: molecular biology and microbiology – Virus or bacteriophage – except for viral vector or... – Recovery or purification
Reexamination Certificate
2006-02-07
2006-02-07
Housel, James (Department: 1648)
Chemistry: molecular biology and microbiology
Virus or bacteriophage, except for viral vector or...
Recovery or purification
C435S235100, C435S320100
Reexamination Certificate
active
06995006
ABSTRACT:
This invention provides methods and compositions for producing high titer, substantially purified preparations of recombinant adeno-associated virus (AAV) that can be used as vectors for gene delivery. At the onset of vector production, AAV producer cells of this invention typically comprise one or more AAV packaging genes, an AAV vector comprising a heterologous (i.e. non-AAV) transgene of interest, and a helper virus such as an adenovirus. The AAV vector preparations produced are generally replication incompetent but are capable of mediating delivery of a transgene of interest (such as a therapeutic gene) to any of a wide variety of tissues and cells. The AAV vector preparations produced according to this invention are also substantially free of helper virus as well as helper viral and cellular proteins and other contaminants. The invention described herein provides methods of producing rAAV particles by culturing producer cells under conditions, such as temperature and pH, that promote release of virus. Also provided is a quantitative, high-throughput assay useful in the assessment of viral infectivity and replication, as well as in the screening of agent that affect viral infectivity and/or replication.
REFERENCES:
patent: 4797368 (1989-01-01), Carter et al.
patent: 5139941 (1992-08-01), Muzyczka et al.
patent: 5173414 (1992-12-01), Lebkowski et al.
patent: 5316938 (1994-05-01), Keen et al.
patent: 5436146 (1995-07-01), Shenk et al.
patent: 5474931 (1995-12-01), DiSorbo et al.
patent: 5587308 (1996-12-01), Carter et al.
patent: 5652224 (1997-07-01), Wilson et al.
patent: 5656785 (1997-08-01), Trainor et al.
patent: 5658776 (1997-08-01), Flotte et al.
patent: 5756283 (1998-05-01), Wilson et al.
patent: 5837484 (1998-11-01), Trempe et al.
patent: 5856152 (1999-01-01), Wilson et al.
patent: 5866552 (1999-02-01), Wilson et al.
patent: 5871982 (1999-02-01), Wilson et al.
patent: 5872154 (1999-02-01), Wilson et al.
patent: 6001557 (1999-12-01), Wilson et al.
patent: 6143548 (2000-11-01), O'Riordan et al.
patent: 6162796 (2000-12-01), Kaplitt et al.
patent: 6174527 (2001-01-01), Wilson et al.
patent: 6183993 (2001-02-01), Boyce et al.
patent: 6194191 (2001-02-01), Zhang et al.
patent: 6203975 (2001-03-01), Wilson et al.
patent: 6211160 (2001-04-01), Wilson et al.
patent: 6251957 (2001-06-01), Wilson et al.
patent: 6258595 (2001-07-01), Gao et al.
patent: 6261551 (2001-07-01), Wilson et al.
patent: 6270996 (2001-08-01), Wilson et al.
patent: 6274354 (2001-08-01), Wilson et al.
patent: 6281009 (2001-08-01), Boyce
patent: 6281010 (2001-08-01), Gao et al.
patent: 6338953 (2002-01-01), Boyce et al.
patent: 6346415 (2002-02-01), Feldhaus
patent: 6365394 (2002-04-01), Gao et al.
patent: 6436392 (2002-08-01), Engelhardt et al.
patent: 6475769 (2002-11-01), Wilson et al.
patent: 6479273 (2002-11-01), Bogedain et al.
patent: 6482634 (2002-11-01), Wilson et al.
patent: 6537540 (2003-03-01), Burstein et al.
patent: 6541258 (2003-04-01), Allen et al.
patent: 6548286 (2003-04-01), Samuski et al.
patent: 6566118 (2003-05-01), Atkinson et al.
patent: 6596535 (2003-07-01), Carter
patent: 6610290 (2003-08-01), Podsakoff et al.
patent: 6610321 (2003-08-01), Huang et al.
patent: 6632670 (2003-10-01), Wadsworth et al.
patent: 6642051 (2003-11-01), Lynch et al.
patent: 6660514 (2003-12-01), Zolotukhin et al.
patent: 6686200 (2004-02-01), Dong et al.
patent: 2002/0001581 (2002-01-01), Lynch et al.
patent: 2002/0028497 (2002-03-01), Blanche et al.
patent: 2002/0090717 (2002-07-01), Gao et al.
patent: 2002/0131956 (2002-09-01), Walsh et al.
patent: 2002/0164783 (2002-11-01), Feldhaus
patent: 2003/0082145 (2003-05-01), Johnson
patent: 2003/0119191 (2003-06-01), Gao et al.
patent: 2003/0175974 (2003-09-01), Allen
patent: 34470/97 (1998-01-01), None
patent: 2 750 433 (1998-01-01), None
patent: WO 93/24641 (1993-12-01), None
patent: WO 94/13788 (1994-06-01), None
patent: WO 95/06743 (1995-03-01), None
patent: WO 95/13365 (1995-05-01), None
patent: WO 95/13392 (1995-05-01), None
patent: WO 95/27071 (1995-10-01), None
patent: WO 95/34670 (1995-12-01), None
patent: WO 95/34671 (1995-12-01), None
patent: WO 96/13597 (1996-05-01), None
patent: WO 96/13598 (1996-05-01), None
patent: WO 96/17947 (1996-06-01), None
patent: WO 96/26285 (1996-08-01), None
patent: WO 96/26286 (1996-08-01), None
patent: WO 96/27677 (1996-09-01), None
patent: WO 96/39530 (1996-12-01), None
patent: WO 97/06243 (1997-02-01), None
patent: WO 97/08298 (1997-03-01), None
patent: WO 97/09441 (1997-03-01), None
patent: WO 97/17458 (1997-05-01), None
patent: WO 97/21825 (1997-06-01), None
patent: WO 97/32990 (1997-09-01), None
patent: WO 98/09656 (1998-03-01), None
patent: WO 98/09657 (1998-03-01), None
patent: WO 98/10086 (1998-03-01), None
patent: WO 98/10088 (1998-03-01), None
patent: WO 98/11243 (1998-03-01), None
patent: WO 98/23018 (1998-05-01), None
patent: WO 98/27204 (1998-06-01), None
patent: WO 98/27207 (1998-06-01), None
patent: WO 99/11764 (1999-03-01), None
patent: WO 99/14351 (1999-03-01), None
patent: WO 99/15677 (1999-04-01), None
patent: WO 99/15685 (1999-04-01), None
patent: WO 99/20773 (1999-04-01), None
patent: WO 99/20779 (1999-04-01), None
patent: WO 99/47691 (1999-09-01), None
patent: WO 99/60146 (1999-11-01), None
patent: WO 00/14205 (2000-03-01), None
patent: WO 00/28061 (2000-05-01), None
patent: WO 00/55342 (2000-09-01), None
patent: WO 00/73480 (2000-12-01), None
patent: WO 00/75353 (2000-12-01), None
patent: WO 00/75365 (2000-12-01), None
patent: WO 00/77233 (2000-12-01), None
patent: WO 01/23001 (2001-04-01), None
patent: WO 01/23597 (2001-04-01), None
patent: WO 01/25462 (2001-04-01), None
patent: WO 01/25465 (2001-04-01), None
patent: WO 01/40455 (2001-06-01), None
patent: WO 01/44280 (2001-06-01), None
Bantel-Schaal Virology 1991 vol. 182, pp. 260-268.
Wistuba, A. et al. (Feb. 1997). “Subcellular Compartmentalization of Adeno-Associated Virus Type 2 Assembly,”Journal of Virology71(2):1341-1352.
Wobus, C. E. et al. (Oct. 2000). “Monoclonal Antibodies Against the Adeno-Associated Virus Type 2 (AAV-2) Capsid: Epitope Mapping and Identification of Capsid Domains Involved in AAV-2-Cell Interaction and Neutralization of AAV-2 Infection,”Journal of Virology74(19):9281-9293.
Afione, S.A., et al. (May 1996). “In Vivo Model of Adeno-Associated Virus Vector Persistence and Rescue,”J. Virol.70(5):3235-3241.
Allen, J.M. (Sep. 1997). “Identification and Elimination of Replication-Competent Adeno-Associated Virus (AAV) That Can Arise by Nonhomologous Recombination During AAV Vector Production,”J. of Virol.71(9):6816-6822.
Antoni et al. (Jan. 1991). “Adeno-Associated Virus Rep Protein Inhibits Human Immunodeficiency Virus Type 1 Production in Human Cells”.J. Virol.65(1):396-404.
Arispe, N. et al. (Mar. 1992). “Intrinsic Anion Channel Activity of the Recombinant First Nucleotide Binding Fold Domain of the Cystic Fibrosis Transmembrane Regulator Protein,”Proc. Natl. Acad. Sci. USA,Cell Biology 89:1539-1543.
Atkinson, E.M. (1998). “A High-Throughput Hybridization Method for Titer Determination of Viruses and Gene Therapy Vectors,”Nucleic Acids Research26(11):2821-2823.
Ausubel, F.M. et al., Eds. (1995).Current Protocols in Molecular Biology.John Wiley & Sons, Inc. vol. I, Table of Contents, Supplement 39, pp. iii-xii.
Bantel-Schaal, U. (1993). “Carcinogen-Induced Accumulation of Adeno-Associated Parvovirus DNA is Transient as a Result of Two Antagonistic Activities That Both Require de novo Protein Synthesis,”Int. J. Cancer53:334-339.
Barr, D. et al. (1995). “Strain Related Variations in Adenovirally Mediated Transgene Expression from Mouse Hepatocytes in vivo: Comparisons Between Immunocompetent and Immunodeficient Inbred Strains,”Gene Therapy2:151-155.
Berns, K.I. (1990). “Parvoviridae and Their Replication,” Chapter 62 InVirology.2ndedition. Raven Press, NY. pp. 1743-1763.
Bibila, T.A. et al. (1994). “Monoclonal Antibody Process Development Using Medium Concentrates”Biot
Aranha Ian L.
Atkinson Edward M.
Fung Victor P.
Reynolds Thomas C.
Takeya Ryan K.
Hill Myron G.
Housel James
Morrison & Foerster / LLP
Targeted Genetics Corporation
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