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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE M @j
`
`PATENT DOCKET 15001
`
`f
`
`HECESVED
`
`In re Application of:
`
`SHUEL CABILLY ET AL.
`
`Serial No. 07/205,hl9 Filed: 05/10/33
`
`For:
`
`RECOMBINANT IMMUNOGLOBULIN
`PREPARATIONS
`
`@\J\/\/\/\/\/\/\/\/\/\./
`
`Art Unit:
`
`185
`
`Examiner—in—Chief:
`Mike Nisbet
`EOARD OF PATENT APPEALS
`AND!NTERFERENCES
`
`SEP 25 1991
`
`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
`
`Sir:
`
`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. O6/483,457, now issued as US
`
`Patent 4,816,567.
`
`The ‘S67 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
`
`Sanofi/Regeneron Ex. 1013, pg 433
`
`Mylan Ex. 1013, pg 433
`
`
`
`..-_
`n
`
`4
`
`O7/102,572
`
`Page No.
`
`2
`
`submitted herewith as Groups III and IV.
`
`The Group III
`
`items
`
`relate to the expression of
`
`imunoglobulin mRNA
`
`microinjected into Xenopug
`
`(frog) oocytes
`
`(unfertilized eggs).
`
`These are
`
`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
`
`GROUP I
`
`and light chains.
`
`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(l0):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. 4l:2073—2078 (1981)
`
`Nisonoff et al. Arch, Biochem. Biophys, 93:460—462 (1960)
`
`Glennie et al. Nature 295:712—7l4 (1982)
`
`Eisen Immunology Harper & Row, Publishers, pp. 415 and 428-436 (1974)
`
`Hozumi et al. Nuc. Acids. Res. 5(6):l779-1799
`
`Wetzel et al. gene 16:63-71 (1981)
`
`Sanofi/Regeneron Ex. 1013, pg 434
`
`Mylan Ex. 1013, pg 434
`
`
`
`07/102,572
`
`Page No. 3
`
`Williams et al. Science 2l5:687—689 (1982)
`
`Falkner et al. Nature 298:286—288 (1982)
`
`osium
`Boss et al. Gene Ex ressions—Proc. Cetus—UCLA S
`
`
`pp. 513-522, March 26-
`
`April 1, 1983
`
`Amster et al. Nucleic Acid Research 8(9):2055—206S (1980)
`
`DeBoer et al., Rodriguez et al.
`
`(Ed.) Promoters 462-481 (1982)
`
`Cough Iihg 6(8):203-205 (August, 1981)
`
`Morrison J, of Lmmunologx l23(2):793-800 (August, 1979)
`
`Kohler Proc. Natl, Acad, Sci, 77(4):2l97-2199 (April, 1980)
`
`Roberts Promoters 452-461 (1982)
`
`Kemp et al. Proc. Natl, Acad. Sci, 78(7):4520-4524 (July, 1981)
`
`Valle et al. Nature
`
`300:7l—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 Eukarxotic Viral and Cellular Genes
`
`Pettersson et al.
`
`(Ed.) 295-303 (1981) Academic Pr.
`
`Keshet et al. Nucleic Acids Res. 9(l):19—30 (1981)
`
`Taniguchi et al. Proc. Natl. Acad. Sci. 77(9):5230—5233 (1980)
`
`Ohsuye et al. Nucleic Acids Res. 1l(5):l283—l295 (1983)
`
`Kadonaga et al. J, Biol, Chem. 259(4):2l49-2154 (1984)
`Maniatis
`
`Molecular Cloning p.433 (September, 1985)
`
`Fujisawa et al. Nucleic Acids Res. 11(1l):358l—359l
`
`(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 l9:27ll—2719 (1980)
`
`Sanofi/Regeneron Ex. 1013, pg 435
`
`Mylan Ex. 1013, pg 435
`
`
`
`.,.
`
`4
`
`07/102,572
`
`Page No. 4
`
`Haley et al. QEA 1:1S5—162 (1982)
`
`Gough et a1. Biochemistry 19:2702—27l0 (1980)
`
`Iserentant et a1. gene 9:1-12 (1980)
`
`Seidman et al. Nature 271:582—585 (1978)
`
`GROUP III
`
`Stevens et al. J. Mol, giol, 78:517-525 (1973)
`
`Deacon et al.
`
`Biochem. Soc,
`
`Trans. 4:818-820 (1976)
`
`Colman et al. Cell l7:5l7—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. 90:69l—701 (1974)
`
`Morrison et al. J,
`
`Immunol, 1l4:6S5—659 (1975)
`
`Immunol. 115:955-962 (1975)
`Mosmann et al. J,
`Proc.
`Nat. Acad Sci. 75:2hl1—2h15 (1978)
`Levy et al.
`Robertson et al. Nature 287:390—392 (1980)
`
`Mosmann et a1. gel; 20:283-292 (1980)
`
`Wilde et al. Eur. J.
`
`Immunol.
`
`l0:462—467 (1980)
`
`Ochi et al. Nature 302:340-342 (March 24, 1983)
`
`Kemp et al.
`
`in Nagley et al.,
`
`Eukaryotes Proceedings of
`
`an International Conference,
`
`in
`Ed., Manipulation and Expression of Genes
`12th International
`
`Congress of Biochemistry,
`
`in Australia 9-13 August, 1982 (1983)
`
`Picard et al. Proc. Nat. Acad. Sci. 80:417-A21 (January, 1983)
`
`Oi et al. Proc. Nat. Acad. Sci. 80:825-829 (February, 1983)
`
`Hawley et al. Proc. Nat, Acad. Sci. 7927425-7429 (December, 1982)
`
`Boss et a1.
`
`Immunology Today 6(l):12-13 (1985)
`
`Lewin, Ed. gene; 3rd Edition, 359-360 (1987)
`
`Skerra et al. Science 240:1038—l04O (1988)
`
`Kohler et al. Eur, J,
`
`lmmunol. 6:292-295 (1976)
`
`One copy of each item cited above in Groups II—IV is supplied, along with
`
`a completed Form PTO-1449.
`record.
`
`The Examiner is requested to make the citations of
`
`Sanofi/Regeneron Ex. 1013, pg 436
`
`Mylan Ex. 1013, pg 436
`
`
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`..
`
`L ,.
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`V
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`I
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`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.
`
`WM
`
`ax D. Hensley
`Reg. No. 27, 043
`
`hereby carfify that his correspondence is bell"!
`--posifed with the Uniled Shakes Posial Service 65
`“.4. C155; mail
`in an envelope addressed fo: Com;
`Issioner of Pafenfs and Trademarks. V/aShi“9*°",v_
`I
`O.C.. 20231 on
`_
`
`Dated:
`
`September 18, 1991
`
`(Dafo of
`{\ arm A)
`
`eposii)
`AT
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`a
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`'
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`W D
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`afe o§ Signafure
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`Sanofi/Regeneron Ex. 1013, pg 437
`
`Mylan Ex. 1013, pg 437