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Krav
Fullmektig i Norge:
Fullmektig i EP:
2007.04.03, EP 07006988
2007.04.03, EP 07006990
2008.03.13, EP 08004741
2007.04.24, US 931688 P
DA COSTA L ET AL: "Immune recruitment by bispecific antibodies for the treatment of Hodgkin disease" CANCER CHEMOTHERAPY AND PHARMACOLOGY, SPRINGER VERLAG, BERLIN, vol. 46, no. SUPPL, 1 January 2000 (2000-01-01), pages S33-S36, XP002955294 ISSN: 0344-5704 (B1)
HAYASHI HIROKI ET AL: "A highly effective and stable bispecific diabody for cancer immunotherapy: cure of xenografted tumors by bispecific diabody and T-LAK cells." CANCER IMMUNOLOGY, IMMUNOTHERAPY : CII JUN 2004, vol. 53, no. 6, June 2004 (2004-06), pages 497-509, XP002499717 ISSN: 0340-7004 (B1)
WO-A-2005/061547 (B1)
WO-A-2005/118635 (B1)
WO-A-2007/033230 (B1)
WO-A-2007/042261 (B1)
"A Critical Analysis of Monoclonal Antibodies in Transplantation Therapy", Extract from Burlingham, 1992, (B2)
02 phage display alanine scanning (B2)
ARNETT ET AL. "Crystal structure of a human CD3-E/5 dimer in complex with a UCHT1 single-chain antibody fragment."Proceedings of the National Academy of Sciences of the United States of America, Vol. 101, No. 46,16268-16273,(November 16,2004) (B2)
Alibaud et al. "A New Monoclonal Anti-CD3? Antibody Reactive on Paraffin Sections." Journal of Histochemistry &Cytochemistry 48(12): 1609-1616, 2000 (B2)
Alignment of CD3e extracellular domains from D28-D33 ( filedby 01), prepared by 01 (B2)
Alignment of SP34 variable domains with SEQ ID NOs 2 and 4from D6 (B2)
Alignment of human, Callithrlx jacchus, Sanguinus oedipusand Saimiri sciureus CD3e N-terminal sequences, prepared bythe 01 (B2)
Alignment of sequences of human, cynomolgus and marmoset CD3e of D34, D35 and D36 (filed by 07) (B2)
Alignment of variable domains from the prior art and the patent (B2)
Amino acid sequence alignment of SP34 with SEQ.ID NOs: 2,4 of WO 2007/042261 (B2)
Amino acid sequence alignments of CD3e (human/monkey) (B2)
Amino acid sequences from human, cynomolgus, C. jacchus,S. oedipus and S. sciureus CD3e (B2)
Angeletti, 1999. Journal of Biomolecular Techniques, 10:2-10 (B2)
Archived webpage from 7 September 2006 (B2)
BAKER et al.: "protein x-ray crystallography", Handbook of Neurochemistry and Molecular Neurobiology, 2007, page 466, (B2)
BD Pharmingen Data Sheet on SP34 (product #556611) (B2)
BD Pharmingen Data sheet on SP34 (product #557052, (B2)
BD Pharmingen Safety Sheet on SP34 (product #556611) (B2)
BD Pharmingen: Technical Data Sheet for SP34 (dated13.05.2003) (B2)
BELLO ET AL. "Loss of N-terminal Charged Residues of MouseCD3e Chains Generates Isoforms Modulating Antigen T Cell Receptor-mediated Signals and T Cell Receptor-CD3Interactions." The Journal of Biological Chemistry, Vol. 282,No. 31, 22324-22334, (August 3, 2007) (B2)
BERKHOUTT ET AL. "Transfection of genes encoding the T cell receptor-associated CD3 complex into COS cells results in assembly of the macromolecular structure. " The Journal of Biological Chemistry, Vol. 263 No. 17, 8528-8536, (June 15, 1988) (B2)
BRISCHWEIN et al.: "strictly target cell dependent activation of T cells by bispecific single chain antibody constructs of the Bite Class", J. Immunotherapy, vol. 30, no. 8, 2007, pages 798-807, (B2)
Blumberg et al., 1990, "Structure of the T-cell antigen receptor: Evidence for two CD3e subunits in the T-ceilreceptor-CD3 complex", Proc. Natl. Acad. Sci. USA Immunology, vol. 87, pp. 7220-7224 (B2)
Bortoletto, N. et al.; Eur. J. Immunol. 2002, 32:3102-3107(2002) (B2)
Brok et al., 2001. Cytometry, 45:294-303 (B2)
CD3e N-terminal peptide bound to the CDRs ofSP34. (B2)
CDR sequence comparison of CD3e antibodies of the patent and prior art (B2)
COLE et al.: "human IgG2 variants od chimeric anti CD3 are nonmitogenic to T cells", The Journal of Immunology, vol. 159, 1997, pages 3613-3621, (B2)
CRIADO ET AL. "Variability of invariant mouse CD3e chains detected by anti-CD3 antibodies." European Journal of Immunology, Vol. 30.1469-1479 (2000) (B2)
Callithrix jacchus CD3e, published 25th September 2005 (B2)
Carter.; Nature Reviews, Immunology (2006); 6:343-357 (B2)
Conrad et al., 2007. International Society For Analytical Cytometry, 71A:925-933 (B2)
Contamin H. et al., J Immunol. Meth. 297 (2005) 61-71 (B2)
Da Costa et al., 2000. Cancer Chemotherapy and Pharmacology, 46: S33-S36 (B2)
Data of Opponent regarding SEQ ID NO: 12 of D6 (B2)
Declaration of Patrick-Peter Hoffmann filed by the patentee in relation to EP2155788 (B2)
Definition of "epitope" from Oxford Dictionary of Biochemistry & Molecular Biology (B2)
EP-A2- 2 520 590 (B2)
Email from BO Biosciences confirming (i) the date ofavailability of SP34 and SP34-2 and (ii) that their binding specificities are identical (B2)
Experimental data from 02 (B2)
Experimental data of 06 regarding SP34 antibody (B2)
Experimental report showing SP34 binding specificity to N-terminus of Callithrix jacchus and Sanguinus oedipus CD3e (B2)
Extract from Meloen et al. (1997) in Immunology Methods Manual, Academic Press Ltd (B2)
Extracts from the Wetherall report, (B2)
FDA guidance on NonClinical safety studies (B2)
FRASER-REID et al.: "synthesis and applications of biologically relevant glycopeptides", Glycoscience - Chemistry and Chemical Biology, 2001, (B2)
FSE mutation data (B2)
Further cytokine secretion data (B2)
Gilliland et al., 1998. PNAS, 85:7719-7723 (B2)
Hayashi et al., 2004. Cancer Immunol. Immunother. 53:497-509 (B2)
Human CD3e, published 28th February 2007 (B2)
In vitro T cell assay data (B2)
Interactions between CD3e and SP34 CDR residues (B2)
Investigation of human CD3e variants binding to monoclonal antibodies, prepared by 07 (B2)
KJER-NIELSEN ET AL. "Crystal structure of the human T cell receptor CD3ey heterodimer complexed to the therapeutic mAb OKT3." Proceedings of the National Academy of Sciences of the United States of America, Vol. 101, No. 20,7675-7680,(May 18, 2004) (B2)
Kontermann, 2005. Acta Pharmacologica Sinica, 1:1-9 (B2)
Kornackeret al., 2006. Cytotherapy, 8:13-23 (B2)
LOBO et al.: "murine monoclonal IgG antibodies: differences in their IgG isotypes can affect the antibody effector activity when using human cells", Immunology and Cell Biology, vol. 75, 1997, pages 261-274, (B2)
Liao et al.; Oncology Reports (1996); 3: 637-644 (B2)
Loisel et al.; Critical Reviews in Oncology/Hematology (2007);62: 34-42 Available online 2 January 2007 (see annex to D20) (B2)
Macaca fascicularis CD3e FN18+ allele, published 9thNovember 2001 (B2)
Macaca fascicularis CD3e FN18- allele, published 9thNovember 2001 (B2)
Macaca mulatta CD3e, published 14th June 2006 (B2)
Mansfield.; Comparative Medicine (2003); 53(4): 383-392 (B2)
Model of the N-terminal residues 1-11 of CD3e ina fully extended conformation folded back on theCD3s molecule (B2)
NPH Reagent Resource , archived webpage of 17 January 2006 (B2)
New experimental data.from 02 (B2)
Non-human primates reagent resource at Harvard University (B2)
Nucleotide and amino acid sequence of human CD3e(December 23,2003) (B2)
Opposition Brief of Hoffmann-La Roche AG in opposition against EP2155788 (B2)
Opposition Brief of Janssen Biotech Inc. in opposition against EP2155788 (B2)
PEARLMAN et al.: "Formulation, Characterisation and Stability of Protein Drugs", Case Histories, 1996, (B2)
Package insert for SP34 antibody dated 27 December 2001 (B2)
Page 192 of BD Biosciences catalogue - on archived webpage from 24 November 2005 (B2)
Pan troglodytes CD3e, published 15th September 2006 (B2)
Patentee?s SP34 affinity experiments (B2)
Peptide scan analysis of SP34 binding epitope (B2)
Pessano et al.; EMBO Journal (1985); 4(2): 337-344 (B2)
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, U. S.Department of Health and Human Services, Food and Drug Administration, 28 February 1997 (B2)
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, ICH Harmonised Tripartite Guideline S6(R1)of the International Conference on Harmonistaion of Technical Requirements for Registration of Pharmaceuticals for Human Use, 15 July 1997 (B2)
RICHARD et al.: Methods in Enzymology, vol. 463, no. 2nd Edition, 2009, (B2)
Results of alanine-scanning experiment of the terminal 27amino acids of CD3e using SP34 carried out by 04 (B2)
Results of alanine-scanning experiment of the terminal 27amino acids of CD3e using SP34, A2J and H2C carried out by02 (B2)
Results of alanine-scanning experiment of the terminal amino acids of CD3e using SP34 carried out by 02 in connection with their Opposition to EP 2 155 788 B1 (B2)
Reusch et al., 2006. Clin Cancer Res, 12:183-190 (B2)
Rogers et al., 2004. Immunology, 113:178-186 (B2)
Rogers et al? 2006. J Immunol, 177:3848-3856 (B2)
Rossi et al., 2008, International Immunology, 20:1247-1258 (B2)
SALMERON ET AL. "A conformational epitope expressed upon association of CD3e with either CD3-6 or CD3-y is the main target for recognition by anti-CD3 monoclonal antibodies."The Journal of Immunology, Vol. 147,3047-3052, (November1,1991) (B2)
SP34 binding experiments prepared by 02 (B2)
SP34 product insert (B2)
STRYER: Biochemistry, 1999, (B2)
SUN ET AL "Solution structure of the CD3e8 ectodomain and comparison with CD3ey as a basis for modeling T cell receptor topology and signaling." Proceedings of the National Academy of Sciences of the United States of America, Vol. 101, No.48,16867-16872, (November 30, 2004) (B2)
Sambrook, Joseph, and David W. Russell, Molecular cloning: a laboratory manual - third edition, 2001, Cold Spring Harbor Laboratory Press, New York, USA; Appendix 7.1 "Codons and Amino Acids" (B2)
Sambrook, Joseph, and David W. Russell, Molecular cloning: a laboratory manual - third edition, 2001, Cold Spring Harbor Laboratory Press, New York, USA; Information panel 13.81,"Alanine-scanning Mutagenesis" (B2)
Sancho et al., 1992. The Journal of Biological Chemistry, 267:7871-7879 (B2)
Scheuermann and Racila, 1995, "CD19 antigen in leukemia and lymphoma diagnosis and immunotherapy" (Abstract), Leuk Lymphoma, vol. 18(5-6), pp. 385-97 (B2)
Schlereth B. et al., Cancer Res 65 (2005) 2882-2889 (B2)
Schlereth et al.; Cancer Immunol Immunother (2006); 55:503 -514 (B2)
Sequence analysis from examples of D6 (B2)
Sequence comparison of the N-terminal protein sequences ofGD3e inhumans and Callithrix jacchus (common marmoset),Saguinus oedipus (cotton-top tamarin) and Saimiri sciureus(squirrel monkey) prepared by 04 (B2)
Sequence data relating to antibody SP34 (B2)
Sequence of Callithrix jacchus (white tufted-ear marmoset)CD3e (B2)
Sequence of Human CD3e (B2)
Sequencing of SP34 (B2)
Superposition of the SP34:peptide structure and the CD3e structure (B2)
Technical data sheet for SP34- 2 (Purified mouse anti-humanCD3) (B2)
Technical report prepared by the 01 (B2)
UDA ET AL. "Identification of an amino acid responsible forthe CD3 polymorphism in cynomolgus monkeys (Macaca fascicularis)" Journal of Medical Primatology, Vol. 32,105-110, (2003) (B2)
US-A- 6 037 453 (B2)
US-A1- 2002 173 629 (B2)
US-A1- 2006 177 896 (B2)
WANG AND NEVILLE. "Expression and characterization of recombinant soluble monkey CD3 molecules: mapping theFN18 polymorphic epitope." Molecular Immunology, Vol. 40,1179-1188,(2004) (B2)
WO-A1-2004/106383 (B2)
WO-A1-91/06319 (B2)
WO-A1-99/54440 (B2)
WO-A2-00/41474 (B2)
WO-A2-03/087131 (B2)
WO-A2-2004/106380 (B2)
WO-A2-2005/056606 (B2)
WO-A2-2005/061547 (B2)
WO-A2-2005/099755 (B2)
WO-A2-2005/118635 (B2)
WO-A2-2007/033230 (B2)
WO-A2-2007/042261 (B2)
WO-A2-99/01556 (B2)
WU: Column Handbook for Size Exclusion Chromatography, 1999, page 90, (B2)
Wilson et al., 1994. Journal of Immunological Methods, 178: 195-200 (B2)
Yoshino N. etal., Exp. Anim.49,97-110, 2000 (B2)
actual data sheet of SP34 (B2)
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