Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
1999-11-24
2002-02-19
O'Sullivan, Peter (Department: 1621)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S019300, C514S020800, C514S533000, C514S534000, C514S547000, C514S604000, C514S614000, C514S615000, C554S091000, C554S106000, C560S013000, C560S034000, C560S041000, C564S081000, C564S082000, C564S091000, C564S149000, C564S151000, C564S153000
Reexamination Certificate
active
06348499
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to cationic lipids use fill in synthetic gene delivery systems. It relates particularly to amphiphilic cationic lipids having conjugated polyamine groups.
BACKGROUND OF THE INVENTION
Plasmid based, non-viral gene delivery systems represent a promising approach for the treatment of inherited and acquired diseases, and for the development of a new approach to vaccination.
1-8
However, their efficiencies and clinical potencies are limited today due to low level in vitro and in vivo gene product expression.
6,9
The commonly used approaches for increasing expression of synthetic gene delivery systems involve either improving the DNA delivery system,
3,4,9
or optimizing the DNA sequence at the level of either the promoter, enhancer, intron, or terminator.
10-13
DNA delivery systems include cationic lipids capable of facilitating the transport of biologically active agents, including plasmids, into the cell both in vitro and in vivo, for example, as disclosed in U.S. Pat. No. 4,897,355 to Eppstein et al. and U.S. Pat. No. 5,264,618 to Felgner et al. Synthetic gene delivery systems also comprise the use of cholesterol-based cationic lipids. Lipids such as DC-cholesterol are shown to have both in vivo and in vitro transfection activity
4,14-18
and were the first cationic lipid molecules to be used in human gene therapy clinical trials. It is medically and commercially important to develop improved species of cationic lipids having enhanced transport or transfective potency.
REFERENCES:
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patent: 5459127 (1995-10-01), Felgner et al.
patent: 5847206 (1998-12-01), Pavia et al.
Caplen et al., “Liposome-mediatedCFTRgene transfer to the nasal epithelium of patients with cystic fibrosis,”Nature Medicine, 1/1:39-46, 1995.
Cooper et al., “Safety-modified episomal vectors for human gene therapy,”Proc. Natl. Science, USA, 94:6450-6455, 1997.
Donnelly et al., “DNA Vaccines,”Annu. Rev. Immunol., 15:617-648, 1997.
Philip L. Felgner, “Improvements in Cationic Liposomes for In Vivo Gene Transfer,”Human Gene Therapy, 7:1791-1793, 1996.
Philip L. Felgner, “Nonviral Strategies for Gene Therapy,”Scientific American, 102-106, Jun. 1997.
Felgner and Rhodes, “Gene Therapeutics,”Nature, 349:351-352, 1991.
Felgner et al., “Lipofection: A highly efficient, lipid-mediated DNA-transfection procedure,”Proc. Natl. Acad. Sci. USA, 84:7413-7417, 1987.
Gao and Huang, “A Novel Cationic Liposome Reagent for Efficient Transfection of Mammalian Cells,” 179/1:280-285, 1991.
Gao and Huang, “Potentiation of Cationic Liposome-Mediated Gene Delivery by Polycations,”Biochemistry, 35:1027-1036, 1996.
Gao and Huang, “Cytoplasmic expression of a reporter gene by co-delivery of T7 RNA polymerase and T7 promoter sequence with cationic liposomes,”Nucleic Acids Research, 21/12:2867-2872, 1993.
Gao and Huang, “Cationic liposome-mediated gene transfer,”Gene Therapy, 2:710-722, 1995.
Liang et al., “Novel, high expressing and antibiotic-controlled plasmid vectors designed for use in gene therapy,”Gene Therapy, 3:350-356, 1996.
Mahato et al., “Cationic Lipid-Based Gene Delivery Systems: Pharmaceutical Perspectives,” 14/7:853-859, 1997.
Roman et al., “Immunostimulatory DNA sequences function as T helper-1-promoting adjuvants,”Nature Medicine, 3/8:849-854, 1997.
Ulmer et al., “Heterologous Protection Against Influenza by Injection of DNA Encoding a Viral Protein,”Science, 259:1745-1749, 1993.
Wolff et al., “Direct Gene Transfer into Mouse Muscle in Vivo,”Science, 247:1465-1468, 1990.
Felgner Philip L.
Gao Xiang
Ling Jing
Gene Therapy Systems, Inc.
Gray Cary Ware & Freidenrich
O'Sullivan Peter
Reiter Stephen E.
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