`
`PATENT DOCKET 150C1
`AND TRADEMARK OFFICE
`
`In re Application of:
`SHMUEL CABILLY ET AL.
`Serial No. 07/205,419
`Filed: 06/10/88
`For: RECOMBINANT IMMUNOGLOBULIN
`PREPARATIONS
`
`RECEIVED
`Art Unit: 185
`SEP 2 5
`Examiner-in-Chief:
`Mike Nisbet
`BOARD OF PATENT APPEALS
`AND INTERFERENCES
`
`460 Point San Bruno Boulevard
`South San Francisco, CA 94080
`(415) 266-1994
`
`INFORMATION DISCLOSURE STATEMENT
`
`Honorable Commissioner of Patents
`and Trademarks
`Washington, D.C. 20231
`
`The following items are supplied to the United States Patent and Trademark
`Office to advance the prosecution of the subject application.
`This application is a continuation of U.S.S.N. 06/483,457, now issued as US
`Patent 4,816,567. The '567 patent is directed to the production of chimeric
`immunoglobulin heavy or light chains. The claims of the '567 patent do not
`exclude the additional expression of light or heavy chain, respectively, and
`therefore cover the production of chimeric immunoglobulins. Therefore, in the
`interests of good order, all of the citations of record in the parent also should
`be made of record here. These citations are listed in Group I below. Copies of
`the citations are not supplied since they are available in the file history of
`the parent. If they should be missing for some reason the undersigned will
`supply an additional copy upon request.
`In addition, this application presently is involved in interference 102,572
`with US Patent 4,816,397 to Boss et al. Group II below contains the citations of
`record from the face of the Boss Patent, copies of which are supplied herewith.
`Further citations have come to the attention of the undersigned, in
`particular from applications related to the Boss and Cabilly Patents. These are
`
`Genzyme Ex. 1013, pg 436
`
`
`
`Page No. 2
`
`07/102,572
`submitted herewith as Groups III and IV.
`The Group III items relate to the expression of immunoglobulin mRNA
`(frog) oocytes (unfertilized eggs).
`microinjected into
`substantially cumulative to Valle et al. (1982) of record in the parent to the
`instant case, but are cited as of interest and to complete the record. Work of
`this sort is readily distinguishable from the instant claims in that the oocytes
`are not transformed with DNA, but instead are used to transiently express mRNA
`preparations.
`For the most part the citations in Group IV are concerned with hybridoma or
`myeloma cells transformed with DNA encoding either an immunoglobulin light or
`heavy chain, or relate to the processing or secretion of immunoglobulins from
`hybridoma and myeloma cells. Thus, they are substantially cumulative to Rice et
`al. (1982), which is of record in the parent, or are of theoretical interest
`only. These disclosures are clearly distinguishable from the instant claims in
`that the cells are not transformed with exogenous DNA encoding both of the heavy
`and light chains.
`
`GROUP I
`
`U.S. Pat. 4,444,878
`U.S. Pat. 4,512,922
`U.S. Pat. 4,518,584
`U.S. Pat. 4,704,362
`EPO 0057107
`EPO 0073656
`EPO 0068763
`EPO 0120694
`Dolby et al. Proc Natl. Acad. Sci. 77(10):6027-6031 (1980)
`Rice et al. Proc. Natl. Acad. Sci. 77:7862-7865 (1982)
`Accolla et al. Proc. Natl. Acad. Sci. 77(1):563-566 (1980)
`Raso et al. Cancer Res. 41:2073-2078 (1981)
`Nisonoff et al. Arch. Biochem. Biophys. 93:460-462 (1960)
`Glennie et al. Nature 295:712-714 (1982)
`Eisen Immunology Harper & Row, Publishers, pp. 415 and 428-436 (1974)
`Hozumi et al. Nuc. Acids. Res. 5(6):1779-1799
`Wetzel et al. Gene 16:63-71 (1981)
`
`Genzyme Ex. 1013, pg 437
`
`
`
`Page No. 3
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`07/102,572
`Williams et al. Science 215:687-689 (1982)
`Falkner et al. Nature 298:286-288 (1982)
`Boss et al. Gene Expressions-Proc. Cetus-UCLA Symposium pp. 513-522, March 26-
`April 1, 1983
`Amster et al. Nucleic Acid Research 8(9):2055-2065 (1980)
`DeBoer et al., Rodriguez et al. (Ed.) Promoters 462-481 (1982)
`Gough Tibs 6(8):203-205 (August, 1981)
`Morrison J. of Immunology 123(2):793-800 (August, 1979)
`Kohler Proc. Natl. Acad. Sci. 77(4):2197-2199 (April, 1980)
`Roberts Promoters 452-461 (1982)
`Kemp et al. Proc. Natl. Acad. Sci. 78(7):4520-4524 (July, 1981)
`Valle et al. Nature 300:71-74 (November 4, 1982)
`Microbiology 3rd edition, Harper Int. Ed. 338-379 (1980)
`Hitzeman et al. Science 219:620-625 (1983)
`Mercereau-Puijalon et al. Expression of Eukaryotic Viral and Cellular Genes
`Pettersson et al. (Ed.) 295-303 (1981) Academic Pr.
`Keshet et al. Nucleic Acids Res. 9(1):19-30 (1981)
`Taniguchi et al. Proc. Natl. Acad. Sci. 77(9):5230-5233 (1980)
`Ohsuye et al. Nucleic Acids Res. 11(5):1283-1295 (1983)
`Kadonaga et al. J. Biol. Chem. 259(4):2149-2154 (1984)
`Maniatis Molecular Cloning p.433 (September, 1985)
`Fujisawa et al. Nucleic Acids Res. 11(11):3581-3591 (1983)
`Roberts Promoters Structures and Function Rodriguez, R. L. (Ed.) 452-461 (1982)
`
`GROUP II
`
`U.S. Pat. 4,403,036
`U.S. Pat. 4,642,334
`EPO 0037723
`EPO 041313
`EPO 041767
`EPO 055945
`EPO 075444
`EPO 088994
`EPO 0125023
`Adams et al. Biochemistry 19:2711-2719 (1980)
`
`Genzyme Ex. 1013, pg 438
`
`
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`Page No. 4
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`07/102,572
`Haley et al. DNA 1:155-162 (1982)
`Gough et al. Biochemistry 19:2702-2710 (1980)
`Iserentant et al. Gene 9:1-12 (1980)
`Seidman et al. Nature 271:582-585 (1978)
`
`GROUP III
`Stevens et al. J. Mol. Biol. 78:517-525 (1973)
`Deacon et al. Biochem. Soc. Trans. 4:818-820 (1976)
`Colman et al. Cell 17:517-526 (1979)
`Valle et al. Nature 291:338-340 (1981)
`Colman et al. J. Mol. Biol. 160:459-474 (September, 1982)
`
`Group IV
`Cowan et al. J. Mol. Biol. 90:691-701 (1974)
`Morrison et al. J. Immunol. 114:655-659 (1975)
`Mosmann et al. J. Immunol. 115:955-962 (1975)
`Levy et al. Proc. Nat. Acad. Sci. 75:2411-2415 (1978)
`Robertson et al. Nature 287:390-392 (1980)
`Mosmann et al. Cell 20:283-292 (1980)
`Wilde et al. Eur. J. Immunol. 10:462-467 (1980)
`Ochi et al. Nature 302:340-342 (March 24, 1983)
`Kemp et al. in Nagley et al., Ed., Manipulation and Expression of Genes in
`Eukaryotes Proceedings of an International Conference, 12th International
`Congress of Biochemistry, in Australia 9-13 August, 1982 (1983)
`Picard et al. Proc. Nat. Acad. Sci. 80:417-421 (January, 1983)
`Oi et al. Proc. Nat. Acad. Sci. 80:825-829 (February, 1983)
`Hawley et al. Proc. Nat. Acad. Sci. 79:7425-7429 (December, 1982)
`Boss et al. Immunology Today 6(1):12-13 (1985)
`Lewin, Ed. Genes 3rd Edition, 359-360 (1987)
`Skerra et al. Science 240:1038-1040 (1988)
`Kohler et al. Eur. J. Immunol. 6:292-295 (1976)
`
`One copy of each item cited above in Groups II-IV is supplied, along with
`a completed Form PTO-1449. The Examiner is requested to make the citations of
`
`Genzyme Ex. 1013, pg 439
`
`
`
`07/102,572
`Page No. 5
`This submission is understood to complement the results of the Examiner's
`own independent search. The submission of this Disclosure Statement should not
`be construed as a representation that a search was made, that the cited items are
`inclusive of all the relevant and material citations that may be available
`publicly, or that designation of membership in a Group means that all disclosure
`relates exclusively to that Group.
`The citation of any item is not an admission that the item is prior art.
`The right is reserved to antedate any item in adherence with standard procedures.
`Respectfully submitted,
`GENENTECH, INC.
`
`Max D. Hensley
`Reg. No. 27, 043
`
`is being
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`
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`
`Genzyme Ex. 1013, pg 440