Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2005-10-25
2005-10-25
Bockelman, Mark (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S522000, C604S021000
Reexamination Certificate
active
06958060
ABSTRACT:
A method is disclosed for delivering molecules such as pharmaceutical drugs and nucleic acids into skeletal muscle in vivo. The molecule is first injected into the muscle at one or multiple sites. Immediately or shortly after injection, electrodes are placed flanking the injection site and a specific amount of electrical current is passed through the muscle. The electrical current makes the muscle permeable, thus allowing the molecule to enter the cell. In the case where nucleic acid is injected, the efficiency of transfer permits expression of protein encoded by the nucleic acid in an amount that exhibits systemic biological activity and which generates a robust immune response.
REFERENCES:
patent: 5273525 (1993-12-01), Hofmann
patent: 5304120 (1994-04-01), Crandell et al.
patent: 5318514 (1994-06-01), Hofmann
patent: 5389069 (1995-02-01), Weaver
patent: 5468223 (1995-11-01), Mir
patent: 5501662 (1996-03-01), Hofmann
patent: 5674267 (1997-10-01), Mir et al.
patent: 5702359 (1997-12-01), Hofmann et al.
patent: 5810762 (1998-09-01), Hofmann
patent: 5944710 (1999-08-01), Dev et al.
patent: 5964726 (1999-10-01), Korenstein et al.
patent: 5993434 (1999-11-01), Dev et al.
patent: 6009347 (1999-12-01), Hofmann
patent: 6041252 (2000-03-01), Walker et al.
patent: 6261281 (2001-07-01), Mathiesen et al.
patent: 6610044 (2003-08-01), Mathiesen
patent: 2003/0018006 (2003-01-01), Tao et al.
patent: WO 95/23211 (1995-08-01), None
patent: WO 98/27966 (1998-07-01), None
patent: WO 98/43702 (1998-10-01), None
patent: WO 99/21175 (1999-01-01), None
patent: WO 00/45823 (2000-08-01), None
Alhara, et al., “Gene Transfer into Muscle by Electroporation In Vivo”,Nature Biotechnology, (1998), 867-870, vol. 16.
Bachy, Monique, et al: “Electric Pulses Increase The Immunogenicity Of An Influenza DNA Vaccine Injected Intramuscularly In The Mouse”Vaccine, (2001), 1688-1693, 19: 13-14, Elsevier Science Ltd,www.elsevier.com/locate/vaccine.
Bhatt, D.; et al.; “Rhabdomyolysis Due to Pulsed Electric Fields”Plastics and Reconstructive Surgery, (1990), 1-11, 86:1.
Block, T.A., et al., “Nonthermally Mediated Muscle Injury and Necrosis in Electrical Trauma”,Journal of Burn Care & Rehabilitation, (1995), 581-588, 16:6.
Collas, P., et al., “The Nuclear Localization Sequence of the SV40 T Antigen Promotes Transgene Uptake and Expression in Zebrafish Embryo Nuclei”,Transgenic Research, (1996), 451-458, vol. 5.
Danko, I., et al, “Pharmacological Enhancement Of in Vivo Foreign Gene Expression In Muscle”Gene Therapy, (1994) 114-121, 1:2, Macmillan Press Ltd., BASINGSTOKE, GB, Mar. 1994.
Davis, H.L., et al., “Direct Gene Transfer into Skeletal Muscle In Vivo: Factors Affecting Efficiency of Transfer and Stability of Expression”,Human Gene Therapy, (1993), 151-159, vol. 4.
Heller, R., et al., “In Vivo Gene Electroinjection and Expression in Rat Liver” (1996), FEBS Letter, 225-228, vol. 389.
Hiroyuki, A., et al., “Gene Transfer into Muscle by Electroporation In Vivo”,Nature Biotechnology, (1998), 867-870, vol. 16.
Hoffman, G.A., “Cell in Electric Fields”,In Electroporation and Electrofusion in Cell Biology, ed.,Neuman, E.; Sowers, A.E. & Jordan, C.A., (1989), 3849-407, Plenum Publishing Corporation.
Katsumi, et al., “Humoral and Cellular Immunity to an Encoded Protein Induced by Direct DNA Injection”,Human Gene Therapy, (1994), 1335-1339, vol. 5.
Kadowaki, Shin-Etsu, et al: “Protection Against Influenza Virus Infection in Mice Immunized By Administration Of Hemagglutinin-Expressing DNAs With Electroporation”Vaccine, (2000), 2779-2788, vol. 18, Elsevier Science Ltd.,www.elsevier.com/locate/vaccine.
Le Borgne, Sylvie, et al., “In Vivo Induction Of Specific Cytotoxic T Lymphocytes In Mice And Rhesus Macaques Immunized With DNA Vector Encoding An HIV Epitope Fused With Hepatitis B Surface Antigen.”Virology, (1998), 304-315, 240:2, Article No.: VY978942, Academic Press.
Lee, R.C., et al., “Transient and Stable Ionic Premeabilization of Isolated Skeletal Muscle Cells After Electrical Shock”,Journal of Burn Care & Rehabilitation, (1993), 528-540, 14:5.
Lim, et al., “Potentiation of Antigen-Specific, Th1 Immune Responses by Multiple DNA Vaccination with an Ovalbumin/Interferon-13Hybrid Construct”,Immunology, (1998), 135-141, vol. 94.
Manthorpe, M., et al., “Gene Therapy by Intramuscular Injection of Plasmid DNA: Studies on Firefly Luciferase Gene Expression in Mice”,Human Gene Therapy, (1993), 419-431, vol. 4.
Martinez, et al., “Combining DNA and Protein Vaccines for Early Life Immunization Against Respiratory Syncytial Virus in Mice”,European Journal of Immunology, (1999), 3390-3400, 29:10 Abstract.
Marthiesen, I.: “Electropermeabilization Of Skeletal Muscle Enhances Gene Transfer In Vivo.”Gene Therapy, (1999), 508-514, 6:4, Stockton Press,www.stockton.press.co.uk/gt.
Mendiratta, Sanjeev Kumar, et al: “Therapeutics tumor immunity induced by polyimmunization with melanoma antigens gp100 and TRP-2”Cancer Research, (2001) 859-863, 61:3.
Miklavcic, D., et al., “The Importance of Electric Field Distribution for Effective In Vivo Electroporation of Tissues”,Biophysical Journal, (1998), 2152-2158, vol. 74.
Nishi, T., et al., “High-Efficiency in Vivo Gene Transfer Using Intraarterial Plasmid DNA Injection Following In Vivo Electroporation”,Cancer Research, (1996), 1050-1055, vol. 56.
Pelegrin, et al., “Genetically Engineered Antibodies In Gene Transfer and Gene Therapy”,Human Gene Therapy, (1998), 2165-2175, vol. 9.
Potter, H., “Electroporation in Biology: Methods, Applications, and Instrumentation”, [Review],Analytical Biochemistry, (1998), 361-373, vol. 174.
Prausnitz, M.R., et al., “Electroporation of Mammalian Skin: A Mechanism of Enhance Transdermal Drug Delivery”,Proc. Natl. Acad. Sci. USA, (1993), 10504-10508, vol. 90.
Richmond, et al., “Studies of the Neutralizing Activity and Avidity of Anti-Human Immunodeficiency Virus Type 1 Env Antibody Elicited by DNA Priming and Protein Boosting”,Journal of Virology, (1998), 9092-9100, 72:11 Abstract.
Rols, M.P., et al., “Electropermeabilization of Mammalian Cells: Quantitative Analysis of the Phenomenon”,Biophysical Journal, (1990), 1089-1098, vol. 58.
Rols, M.P., et al., “In Vivo Electrically Mediated Protein and Gene Transfer in Murine Melanoma”,Nature Biotechnology, (1998), 168-171, vol. 16.
Selby, Mark, et al., “Enhancement of DNA vaccine potency by electroporation in vivo,”Journal Of Biotechnology, (2000), 147-152, 83:1-2, Elsevier Science B.V., www.elsevier.com/locate/biotec.
SIN, Jeong-Im, et al., “DNA priming-protein boosting enhances both antigen-specific antibody and Th1-type cellular Immune reponses in a murine herpes simplex virus-2 gD vaccine model”,DNA And Cell Biology, (1999), 771-779, 18:10.
Smith, L.C., et al., “Advances In Plasmid Gene Delivery And Expression In Skeletal Muscle”,Curr. Opin. Mol. Ther.,(2000), 150-154, vol. 39.
Tekle, E., et al., “Electroporation by Using Bipolar Oscillating Electric Field: An Improved Method for DNA Transfection of NIH 3T3 Cells”,Pro. Natl. Acad. Sci. USA, (1991), 4230-4234, vol. 88.
“The Effects of a Single High Voltage Electrical Stimulation with an Anticancer Drug in In Vivo Growing Malignant Tumors”,Japanese Journal of Surgery, (1990), 197-204, 20:2.
Widera, G., et al., “Increased DNA Vaccine Delivery and Immunogenecity by Electroporation In Vivo”,The Journal of Immunology, (2000), 4635-4640, vol. 164.
Wolf, H., et al., “Control by Pulse Parameters of Electric Field-Mediated Gene Transfer in Mammalian Cells”,Biophysical Journal(1994), 524-531, vol. 66.
Wolff, J.A., et al., “Long-Term Persistence of Plasmid DNA and foreign Gene Expression in Mouse
Lomo Terje
Mathiesen Iacob
BioTechnology Law Group
Bockelman Mark
Chambers Daniel M.
Genetronics Inc.
Murdock Douglas C.
LandOfFree
Method for muscle delivery of drugs, nucleic acids and other... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for muscle delivery of drugs, nucleic acids and other..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for muscle delivery of drugs, nucleic acids and other... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3475605