Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Blood proteins or globulins – e.g. – proteoglycans – platelet...
Reexamination Certificate
2008-01-22
2008-01-22
Blanchard, David J. (Department: 1643)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Blood proteins or globulins, e.g., proteoglycans, platelet...
C530S388100, C530S388220, C530S388730, C530S388800, C424S133100, C424S141100, C424S144100, C424S155100, C435S069600, C435S070210
Reexamination Certificate
active
07321026
ABSTRACT:
Framework (FR)-patching is a novel approach to modify immunoglobulin for reducing potential immunogenicity without significant alterations in specificity and affinity. Unlike previous described methods of humanization, which graft CDRs from a donor onto the frameworks of a single acceptor immunoglobulin, we patch segments of framework (FR1, FR2, FR3, and FR4), or FRs, to replace the corresponding FRs of the parent immunoglobulin. Free assortment of these FRs from different immunoglobulins and from different species can be mixed and matched into forming the final immunoglobulin chain. A set of criteria in the choice of these FRs to minimize or eliminate the need to reintroduce framework amino acids from the parent immunoglobulin for patching is described. The approach gives greater flexibility in the choice of framework sequences, minimizes the need to include parent framework amino acids, and, most importantly, reduces the chances of creating new T- and B-cell epitopes in the resultant immunoglobulin.
REFERENCES:
patent: 4704362 (1987-11-01), Itakura et al.
patent: 5693761 (1997-12-01), Queen et al.
patent: 5693762 (1997-12-01), Queen et al.
patent: 5789554 (1998-08-01), Leung et al.
patent: 5859205 (1999-01-01), Adair et al.
patent: 5908925 (1999-06-01), Cohen et al.
patent: 6187287 (2001-02-01), Leung et al.
patent: 6632927 (2003-10-01), Adair et al.
patent: 4225853 (1994-02-01), None
patent: 0239400 (1987-09-01), None
patent: 8702671 (1987-05-01), None
patent: WO 97/34632 (1997-09-01), None
patent: WO 98/41641 (1998-09-01), None
patent: WO 99/55369 (1999-11-01), None
Rudikoff et al., PNAS 79:1979, 1982.
Paul, Fundamental Immunology, Raven Press, NY, Chapter 8, p. 242, 1993.
Chatterjee et al., Cancer immunol. Immunother. 38:75-82, 1994.
Gura, Science 278:1041-2, 1997.
Ohtomo et al (Molecular Immunology 32:407-416, 1995.
Rudikoff et al (Proc Natl Acad Sci USA 1982 vol. 79 p. 1979.
Benhar et al. Proc. Natl. Acad. Sci. USA, 91(25):12051-12055, Dec. 6, 1994.
Jones et al., Nature, 321: 522-525, 1986.
Verhoyen et al., Science, 239: 1534-1536, 1988.
Huston et al. Proc. Natl. Acad. Sci. USA. 85: 5879-5833, 1988.
Bird et al., Science 242:423-426, 1988.
Hunkapiller and Hood, Nature 323:15-16, 1986.
Davis et al., J. Clin. Oncol. 17:1851-1857, 1999.
Coiffier et al., Blood 92:1927-1932, 1998.
McLaughlin et al., J. Clin. Oncol. 16:2825-2833, 1998.
Amit et al., Science, 233:747-753, 1986.
Chothia and Lesk, J.Mol.Biol.196:901, 1987.
Chothia et al., Nature 342:877, 1989.
Tramontano et al., J. Mol. Biol. 215:175, 1990.
Levy et al., Biochemistry 28:7168-7175, 1989.
Bruccoleri et al., Nature 335:564-568, 1988.
Chothia et al., Science 233:755-758, 1986.
Shaw et al., J Immunol. 138:4534-4538, 1987.
Leung et al., Molecular Immunol. 32:1413-1427, 1995.
Daugherty et al., Nucl. Acid Res. 19:2471-2476, 1991.
Gillam and Smith, Gene 8:81-97, 1979.
Roberts et al., Nature 328:731-734, 1987.
Li et al., Cell Immunol. 118:85, 1989.
Mansfield et al., Blood 90:2020-2026, 1997.
Sanger et al., PNAS 74:5463-5467, 1977.
Sep. 19, 2002, Int'l Search Report.
PCT Notification of Transmittal of the International Preliminary Examination Report for Leung, Shawn Shui-on, Int'l Application No. PCT/US02/18512, Filed Jun. 10, 2002, Dated Dec. 19, 2003.
PCT Written Opinion Leung, Shawn Shui-on, Int'l Application No. PCT/US02/18512, Filed on Jun. 10, 2002, Dated Jan. 16, 2003.
Complaint for Declaratory Judgment and Permanent Injunction (Civil Action No. 2471-N), including Exhibits A-G.
Motion for Special Process Servers (Civil Action No. 2471-N), and Order Appointing Special Process Servers (Civil Action No. 2471-N).
Supplemental Information Pursuant to Rule 3(a) of the Rules of the Court of Chancery.
Lewis, et al. “Generation of humanized monoclonal antibodies by ‘best fit’ framework selection and recombinant polymerase chain reaction” Year Immunology, vol. 7, 110-118, 1993.
Roguska, et al. “A comparison of two murine monoclonal antibodies humanized by CDR-grafting and variable domain resurfacing” Protein Engineering, vol. 9, 895-904, 1996.
Singer, et al. “Optimal humanization of 1B4, an anti-CD18 murine monoclonal antibody, is achieved by correct choice of human V-region framework sequences” J. Immunol., vol. 150, 2844-2857, 1993.
Hamilton, et al. “A humanized antibody against Human Cytomegalovirus (CMV) gpUL75 (gH) for prophylaxis or treatment of CMV infections” J. Infect. Diseases, vol. 176, 59-68, 1997.
Riechmann, et al. “Reshaping human antibodies for therapy” Nature, vol. 332, 323-327, 1998.
Rosok, et al. “A combinatorial library strategy for the rapid humanization of anticarcinoma BR96 Fab” J. Biol. Chem., vol. 271, 22611-22618, 1996.
Shearman, et al. “Construction, expression and characterization of humanized antibodies directed against the human alpha/beta T cell receptor” J. Immunol., vol. 147, 4366-4373, 1991.
Jan. 30, 2007 Supplementary European Search Report from the European Patent Office for European Patent Application No. EP 02734771, filed Jan. 26, 2004.
Fiona Adair, “Immunogenicity: The Last Hurdle for Clinically Successful Therapeutic Antibodies”,BioPharm, pp. 42-46 (Oct. 2000).
Man Sung Co et al., “Humanized Antibodies for Antiviral Therapy”,PNAS USA, vol. 88: 2869-2973 (Apr. 1991).
Elvin A. Kabat et al., “Identical V Region Amino Acid Sequences and Segment of Sequences in Antibodies of Different Specificities”,Journal of Immunology, vol. 147 (5): 1709-1719 (Sep. 1991).
Eduardo A. Padlan, “Anatomy of the Antibody Molecule”,Molecular Immunology, vol. 31 (3): 169-217 (1994).
Tai Te Wu et al., “Possible Use of Similar Framework Region Amino Acid Sequences Between Human and Mouse Immunoglobulins for Humanizing Mouse Antibodies”,Molecular Immunology, vol. 29 (9): 1141-1146 (1992).
Shan, Daming et al., “Characterization of scFV-Ig Constructs Generated from the Anti-CD20 mAb 1F5 Using Linker Peptides of Varying Lengths”, Journal of Immunology, vol. 162: 6589-6595 (1999).
Wu, Tai Te, “From Esoteric Theory to Therapeutic Antibodies”, Applied Biochem and Biotech, vol. 47:107-118 (1994).
Zhengxing, Qu et al., “Humanization of Immu31, an αFetoprotein-specific Antibody”, Clinical Cancer Research, vol. 5 (Suppl.): 3095s-3100s (Oct. 1999).
Blanchard David J.
Skytech Technology Limited
Smith Chalin A.
Smith Patent Consulting
LandOfFree
Framework-patched immunoglobulins does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Framework-patched immunoglobulins, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Framework-patched immunoglobulins will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2778020