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`STATEMENT BY APPLICANT
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`Bennett celsa
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`r 2338-10230
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`Aflorna Docket Number
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`U.S. PATENT DOCUMENTS
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`NON-PATENT LITERATURE DOCUMENTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Examiner Bonl
`Initials
`No.
`
`Include name of lhe author (In CAPITAL l.ElTERs). title 0! the article [when appropriate]. Iltle ul Ine item (hook. megaune, Journal.
`serial. symposium. catalog. elm. dale. pageio). volume-lseuo numborto). publisher. city endlor oounlry where published.
`
`Abbas ell aI.. Cellular and Molecular Immunology, Second Edition pps. 33-39 (1994;
`Abstract. Journal of Nuclear Medicine. May, 1990, No. 513 (Exhibit 1177, um No. 104.532)
`Abstract. The Society of Nuclear Medicine 37"‘ Annual Meeting. Washington Convention Cenler—Washington . D.C..
`Tuesday. June 19-Friday . June 22. 1990 (Exhibit 1130. int. No. 104.532)
`
`
`
`no. 104.532)
`
`Aoslraol. World Federation ofNuclear Medicine 3.Biology. Abstractsubmlllocl January 15. 1990 (Exhibit 1:73. int.
`Achord atal. 1978. Human D-glucuronidasez in lrivoclearance and In vitro uptake by a giycoprcltein recognition
`system on relicuioendothalial cells. Cell 15:269-278
`
`Wiilll Albert-3 elal. Molecular Biology of The Cell, pp. 285 and 375. Garland Publishing, Inc.. (1983)
`1
`
`
`
`
`‘EXAMINER: Ini .r ‘ii rel -—-rloe oorlsldemd. vlrhetheror nolcilatlon is in eonlorrnanoa mm M.P.E.P. § 609. Draw line tllrough cilatian if no! in
`ooniormance fig not considered. include copy oi’ this lonn uritn next oornrnunlcation to Applicant
`ocoocsnlzvsau
`
`3
`3
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`itF°RW*°N °'S°t°5"RE
`STATEMENTV Ati’“°t“T
`
`Attorne Doclretlilurnber
`
`Bennett ceisa
`or 338-10230
`
`NON-‘PATENT LITERATURE DOCUMENTS
`
`serial. symposium. catalog. etc]. date. pagetel. iiolurrie-issue numbartel. putitieher. city andlor country where published.
`
`
`includenameorthe author(InCAPITALLETTERS). titleofthe article(whenappropriate).titleofthe item(hook.magazine.journal.
`Alberts. e. lliloielcularblologle der Zelle. Weinheim: VCH p. 1075 (1937)
`‘
`
`All at al. 'Immunoglot.iulin heavy-chain expression and class switching in a murlne leukaemia cell line.” Nature. Vol.
`298. p. 325-31. (Mar. 25. 1982)
`Andrews. o.w. and JD. Capra. 1980. Clinical lmmunobiology. pp 1-18. we Sanders
`I. Arathoon. etal.- Large-ScaleCell Culture inBiotechnologypages 1390-1395. Science.Vol. 232.June 1988
` (E:id'Iibil 1157: Int. No. 104.532)
`Arthritis 8. Rheumallsrn. Abstract Suppl. Vol. 39. No. 9. Sept 1998. p. 5244
`Ashlord el al. 1993 ‘Site-specific Glycosylation of Recombinant Rat and Human Soluble CD4 Variants Expressed in
`Chinese Hamster Ovary Cells“. J BioL Chem. 268. 3260-3267
`
`
`
`
`
`Initials
`
`Mo.
`
`
`
`
`
`
`
`Bagdasarian etal.. ‘Activityofthe hybrid trplac (lac) promoterclpulida. construction01broad-host-range.
`Baldwin. R.W.atal. 1990. MonoclonalAntibodiesand lmmunoooniugates.TheParthenon Publishing Group(UK). p.
`
`controlled-expression vectors’ Gen 26 (2-3): 273-282 (December 1983)
`
`209
`
`
`
`
`Banerji et al.. ‘A Lymphocyte-Specific Cellular Enhancer ls Located Downstream of the Joining Region in
`lmmunogiobulin Heavy Chain Genes." Coll. vol. 33. 729-740 (July 1982)
`'
`
`J.Baselgaetal..‘RecombinantHumanizedAnti-HER2Antibody(I-lerceptin“')EnhancestheAnlitumorActivityol
`
`Paclitaxe! and Doirombicin against I-lER2i'neu Overeitpressing Human Breast Cancer Xenografls°. Cancer Res.
`(1988) 58: 2825-2831
`
`Beatty et al.. Cancer Research {Suppl.) 50:922s-9265 (Fehniary 1. 1890) {Erhibit 1011: int. No. 104.532)
`Beatly et al.. Cancer Research 49558?-1594 {March 15. 1989) (Exhibit 1010; Int. No. 104.532)
`Bogent et al.. Br. J. Cancer. 62:48? (1990) (Exhibit 1088; Int. No. 104.532)
`
`Benoist. 0.. et al.. ‘In irlvo sequence requirements ofthe SV40 earty promoter region.‘ Nature. 290: 304-310 (1981)
`Bergman. Y.. et al., ‘Two regulatory elements for immunoglobulin kappa light chain gene expression. ‘’ Proc. Natl.
`
`Aced. Sci. 81 :7041-45(1984)
`
`Bemian et al.. Science. 1983 Nov. 4; 22201823): 524-7
`Bemier."ProliferativeDisordersoftheImmune Systern.'Chapter21 (pages622-843)in Bellantl.lmmugglggg II
`onocgenesie.‘ Science. 212: 9-11-43 (1981)
`
`(1978)
`
`Bindcn et al. 1985. Therapeutic potential of monoclonal antibodies to the leukocyte-comrnon antigen. Synergy and
`interference in complement-mediated lysls. Transplantation 40(5):538-44 (Exhibit 2072: int. No. 104.532)
`
`Blatt. C. and J. Haimovlch. 1981. The selective effect of tunicamycin on the secretion of lglit and IgG produced by
`the same cells. European Journal Of Immunology 11:65-66
`
`Blair. DG. et al.. ‘Activation of the trarisiomiirig potential ol a nomial cell sequence: a molecular model (or
`
`
`
`
`
`I
`
`
`
`‘BIAMINER: Initial ir relerierioe considered. whether or not citation is in oorttonnarioe with M.P.E.P. 5 609.Dravr1tne tru-ougii citation it not in
`centorrnanoe @ not considered. lnctude copy of this form with next co:-nmunicelion to Applmnt.
`ocoocsiezrssaa
`
`4
`
`

`
`
`
`' " "°°"°" """"'°' :
`HNFORWIATIIONI DISCLOSURE
`rm 2. o
`Hr;Na:::d lmmr
`STATEMENT BY APPLICANT
`Bennett celsa
`
`
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`
`
`
`
`
`Include name at the author (in CAPITAL LETTERS). title or the artide {when appropriate). title at the Item (book. magazirte.]ourr1aI.
`serial. symposium. catalog. etc). date. pagets). vetume-Issue nurnberls). publisher. city andlor country where published.
`
`Breathnach. R.. et at. “Corrected spticing of a chicken ovelbumin gene transcript in mouse L cells.‘ Proc. Natl. Acad.
`Sci. 7?: 740-44 (1980)
`
`Bruggemann et at. 1987. comparison of the effector functions ct human lrnmunoglobullns using a matched set of
`chimeric antibodies. Journal of Experimental Merflclne 166{5):1351-51 (Exhibit 2079; Int. No. 104.532)
`
`Cabllly. S. and AD. Riggs. 1985. Immunoglobulin transcripts and molecular history of a hybridorna that produces
`antibody to carcinoembryonic antigen. Gene 40(l}:157-B1 (Exhlblt 2073; Int. No. 104,532)
`
`Cabilly. Shmuel. ‘Growth at sub-opllrnal temperatures allows the production of functional. antigen-binding Fab '
`fragments in Escherichia coli’ Gene 85:553-5? (1939)
`
`CancerPrinciples3. Practiceolonoology.5thE1:Iillon.Volume 1. Chapter 13.pages 3eo.372(Exhibit 1131; Int. No.
`
`104.532)
`
`Carter el al., ‘High Level Escltenchla coli Brptesston and Production of a Blvalent Hurnanized Antibody Fragment’
`Bioffechnology 10(2):153—167{Feb 1992)
`
`Chang. E.. et al.. "transformation by cloned Harvey sarcoma vlme DNN elficiency increased by long terrnlnal repeat
`DNA." Science. 210: 1249-51 (1930)
`
`Chang at al.. Proc. Natl. Acad. Sci. USA. Vol. 84. pp 5640-5544 (1957) (Ettltibit 1107; It'll. No. 104.532)
`ll Ctynesetal.. 2000‘InhibitoryFc receptorsmodulateinvivacytoxicityagainsttumorantigens‘NatureMed 6:4143- I
`Cohboldetal.. BoneMarrowPurgingandProcessing.pages 139-154 (January 1. 1990){Exhibit 1027; Int. No.
`
`104.532)
`
`448
`
`Cobbolcl. S.P. and H. Waldmenn, ‘Therapeutic potential of rnonotralent monoclonal antibodies’ Nature
`3oe{595e):4eo-52 (1984) {Exhibit 2063; Int. No. 104.532)
`Code of Medirat Ethlw and Current Opinions. excerpts from pp. 339-379 (Exhibit 2269. Int. No. 104.532)
`Catcher et al., Cancer Res. 49:173B-17o15{t989){Exhlblt 1047: Int. No. 104.532)
`Crowd. at al.. A Clinical Experimental Immunology. 1992. 67. pages 105-110 (Exhibit 1070: Int. No. 104.532)
`Davies. J.. at al.. “A new selective agent for eukaryotic cloning vectors.’ Am J. Trop. Med. Hyg.. 29 (5 Suppl): 1069-
`
`Davis at al. 1990. ‘High Level Expression in Chinese Hamster ovary cells of Soluble Forms of CD4 T Lymphocyte
`Glycoprotetn Including Glycosylation Variants.‘ J Biol. Chem. 235. 10410-10418 (Exhibit 2189: Int. No. 104.532)
`
`Davis. ‘lmmunoglobulin molecules and genes‘ Microbiology Including Immunology and Molecular Gene1lcs.Thlrd
`edition, 1980. Chapter 17, pp. 338-3?9. Harper & Row. Hagerstown. MD
`
`De Waele et al. 1953. Expression in non-tyrnphoid cells of mouse recombinant imrnunoglobulin directed against the
`tumor marker human placental alkailne phosphatase. Euopean Journal of Blochernlslry 1T8:28T-295 {Exhibit 2109;
`Int. No. 104.532)
`
`‘EXAMINER: Initial ll relerence considered. whether or not citation Is In conlorrnartce with M.P.E.P. § 509. Draw line through dtalion ll’ not ln
`Ooftlorrltance and not considered. Include copy ol this form with next cornmunlcalion to Appttcam.
`DCDOCSr'52T59u1.'I
`
`5
`
`

`
`~-~ tutainrlwm IMSNPTO E IMBBIFTO
`
`
`
`
`INFOREWATIJON DIISCILOSURE
`SYATEMENT BY APPLIICANT
`
`
`
`
`
`
`
`
`
`Examiner Box
`Initials
`No.
`
`
`
`
`
`
`
`
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`
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`
`
`
`
`
`Ettinger, et al. Cancer Treatment Reports Vol. 83, No. 1, pages 131-134, January, 1979 (Exhibit 1129; int. No.
`104,532)
`.
`‘
`
`
`
`
`
`
`
`
`Glaser et al.,’ Functional interrelationship between two tandem E.coli ribosornal RNA promoters“ Nature
`302(59031:74-76 (Mar 3, 1983)
`
`
`
`Goeddel et al. 1979. Direct expression in Escherichia coil of a DNA sequence coding for human growth hormone.
`Nature 281(5732):544-8 (Exhibit 2038; Int. No. 104.532)
`
`Goeddel et al.. "Synthesis of Human Fibroblast interferon by E.coli° Nucleic Acids Research 8(18):4057-4074 (1980)
`
`Gillies et al., ‘Expression of cloned immunoglobulin genes introduced into mouse L cells.‘ Nucl. Acids Res., Vol. 11.
`No. 22. Pp. 7982-97 (1983)
`
`
`Finnegan et al.. J. Rheumatology 1997, 24:7, 1448-1449 (Exhibit 1069; int. No. 104,532)
`Fittleretal..‘Lolizationin Mouse-L-CellChromosomal SitesofTransferred lmmunoglobulin Genes.‘Chromosome
`
`
`(Bert) 84, 717-727 (1982)
`Fleischman, J. Bioscience Report 5:893-899 (1985) (Exhibit 1080 Case No. CIV S-00-1252 WES GGH)
`Frenkel etal. 1980. Analysisand detectionofBcell neoplasms. Blood Cells 6:783-793 (Exhibit2123: Int. No.
`104,532)
`
`
`Friend et al.. Transplantation 48:248-253 (August 1. 1989) (Exhibit 1023; Int. No. 104.532)
`Fundenberg and Kolstinen, ‘Human Allotype Detection by Passive Hemagglutlnation. with Special Reference to
`
`lmmunoglobulin A Allotypes° Chapter 103 (pages 767-774) in Rose and Friedman, Manual of Clinical Immunology,
`Second Edition (1980)
`
`
`Geisse et al. 1996. Eukaryotic expression systems: a comparison. Protein Expression and Purification 8:271-282
`(Exhibit 2025; Int. No. 104,532)
`
`
`
`
`
`‘O4;
`-
`'
`Considered
`5’nature
`‘EXAMINER: Initial if reference considered, whether or not citation is in conformance with M.P.E.P. § 609. Draw line through citation if not In
`conformance ag not considered. Include copy of this form with next communication to Applicant.
`DCDOCSI627594.1
`
`
`
`6
`
`NON-PATENT LITERATURE DOCUMENTS
`
`include name of the author (in CAPITAL LETTERS). title of the article (when appropriate), title at the item (book. magazine. journal.
`serial. symposium, catalog. etc.). date. P39e(s). volume-issue numberis). publisher. city and/or country where published.
`
`Dean, C.J. 1994. Preparation and characterization of monocional antibodies to proteins and other cellular
`components. Methods in Molecular Biology 32:361-379 (Exhibit 2026; int. No. 104.532)
`
`
`
`
`
`
`
` DeBoer, ‘The tac promoter. A functional hybrid derived from the trp and lac Promoters" Proc. Natl. Ad. Sci. USA
`80:21-25 (1983)
`
`
`
`Devita et al.. Cancer: Principles & Practice of Oncology, 1997, 5th
`Lippincott-Raven, Philadelphia. PA
`
`
`
`Vol. 1, Chapter 18. VT. Dewta (Ed.),
`
`
`
`Duda et al., J. Surgical Oncology 44:73-77 (June 1990) (Exhibit 1014; Int. No. 104.532)
`Dyer et al.. Blood 73:1431-1439 (May 1, 1989) (Exhibit 1025; int. No. 104.532)
`Emery 8: Adair, Exp. Opln. Invest. Dnrgs (1994) 3(3):241-251(Exhibit 1087; Int. No. 104.532)
`Estabrook A. and J. A. K. Patterson, "lmmunotherapy using
`monoclonal antibodies.’ J. of Cutaneous Pathology 10: 559-66 (1983).
`
`
`
`

`
`
`
`
`
`=
`
`H‘ lorrn '|44'BAr'P'I'O I lM93I‘P'I’0
`
`
`
`
`
`INFORHIAWON [DBSCELOSURE
`STAYEMENT BY APPLICANT
`
`
`
`
`Emlfltljj Atrorne oockemumber
`
`
`
`
`v M0230
`
`NON-PATENT LITERATURE DOCUMENTS
`
`tni
`
`ts
`
`.
`
`serial. syrnposium. catatog. etc}. date. panels). vottn-ne-issue l'llJi'l'Ih8i'[8), puhtisher. city andror country where published.
`
`Includename oitheauthor{incaprrar.LETFERSJ,weofthearticle(whenappropriate).titteertheitem(book.rnagazine..Joun'Iat.
`Goeddel. MethodsinEnzyrnology.Volume 185.AGeneExpressionTechnology(1990)(Exhibit 1077; int. No.
`InGold etat. 1978. Carcinoembryonicantigen {CEA)in cilntcal medicine. Cancer421399-1405{Exl1ibil2135; int. No.
`
`-'
`
`104.532)
`
`104.532)
`
`Goachee el al. 1991. "111e Oligosaocharides of Glyooproteins: BieProcess Factors Affecting Oltgosaocheride
`Structure and their Effect on Glycopmteln Properties“. Bio Technology 9. 1347-1355 {Exhibit 2187; Int. No. 104.532)
`
`Goochee. C. F.. and T. Monica. 1990. Environmental effects on protein glyoosyiation. Bio Technology 8:421-427
`(Exhibit 2023; int. No. 104.532)
`
`Goodman and MacDonald. ‘Cloning of honmne genes front a mixture of cDNA mo!ecuies' Methods in Enzyrnoloqy
`
`68:75-90 (1979) Greipp. P. 1992. Advances in the diagnosis and management of myeloma. Serninare tn Hematology 2913: Suppl.
`
`21:24-45{Exhihit2020: Int. No. 104.532)
`
`-
`
`Grillo-Lopez at al. 1999. Ovenriew of the clinical development of ritunirnab: tirst monootonal antibody treatment
`approved for the treatment of lymphoma. Seminars In Oncology 26:66-73 (Exhibit 2144; Int. No. 104.532)
`
`Gross et al. ‘Bone marrow Purging and Processing. ' International Symposium on Bone Marrow Purging and
`Processing (2nd. Apr. 27 and 28. 1939 Cancun. Mexico) Gross et al. {Ed.). Wiley-Lise. NY
`
`II Grossbard. M.L. 1998. MonoclonalAntibodyBasedTherapyofCancer. MarcelDekker.p.451 (Exhibit2094; Int.
`
`No. 104.532}
`
`-
`
`Gruse. P.. et al.. "Simian virus 40 tandem repeated sequences as an element of the early promoter.’ Proc. Natl.
`Aced. Set. 78: 943-47 (1931)
`_
`
`Habara et al. "Rauscher Murine Leukemia Virus: Molecular Cionlng of infectious integrated Proviral DNA.'. J. of
`Virology. vol. 44. no. 2. pp. 731-35 [No.v 1982)
`
`Hale et al. 1985. Reactivity of rat monoclonal antibody CAMPATH- I with human leukemia oeits and its poesibte
`application for autologoue bone marrow transplantation. British Journal of Hematology 60(I}:41-B (Exhibit 2074: Int.
`No. 104.532)
`
`Haleetal. 1988. RemissioninductioninnonHodgkin lymphomawith reshapedhuman monoclonalantibody
`GAMPATH- I H. Lancet 2 (86251:1394-1399 (Exhibit 2015 and 1024: lint. No. 104.532)
`Hale at al., 1990. The Campath- 1 antigen (CDw52). Tissue Antigens 35:11:;-127 [Exhibit 2049 int. No. 104,532)
`Hale. "Effects oi Monoclonal Anti-tyrnphocyle Antibodies in Vhro in Monkeys and Hurnans'. Moi Bio! Med (1983) 1.
`321-334 {Exhibit 2249; Int. No. 104.532}
`
`I-tale. Progress Report {May 1990 - December 31 , 1990), MRC welloome Therapeutic Antibody center (Exhibit
`1072; int. No. 104.532)
`
`Hamilton. R.. “Application of engineered chimeric antibodies to the calibration of human antibody standards“ Annales
`de Biologle Clinigue 49 {4}:24t2-248 (1991)
`
`I
`
`Harris.‘ExpressionoiEukeryoticGenesinE.eotr‘Genetic Engineering. R.WiIIiamson.4''edition pps. 127-185
`
`(1983)
`
`-
`
`‘EXAMINER: Initial ll‘ reference considered. whether or not citation is in conformance with M.P.E.P. 9 609. Drew line throtrgh citation it not in
`conformance am not considered. tnctude oopy of this lorrn with next oornmunicelton to Applicant
`ocoocerezrseau
`
`7
`
`

`
`
`
`
`
`-- llcaiion Number
`:-
`Filln Date
`
`
`
`
`
`HNFORMATBON ISCILOSURE
`STATEMENT Y APPLICANT
`
`
`Bennett Celsa
`-
`
`EH5-IIE__ Marne Docket Numb“
`2333-10230
`
`NON-PATENT IIJTERATURE DOCUMENTS
`
`Initials
`
`lndudename 01theauthor{inCAPITAL LETTERS). titleofthearticle{when appropriate),title oftheitarn(book.rnagaz1ne.louma!.
`serial. symposium. catalog. etc}. date. Bagels}. volume-issue nurnbents). publisher. city sndror country where putztlshed.
`&M Harris. at al., Proceedings of the 34th Oholo Conference. Eiiat. Israel (1990) (Exhibit 1073; int. No. 104.532]
`Hayn and Welssrnann. ‘Conslitulive. long—tenn production of human inlerferons by hamster cells containing
`multiple copies of a cloned interferon gene.‘ (1983) Nucl. Acid. Res.. Vol. 11 No. 3. pp. 687-706 {Exhibit 1109; Int.
`No. 104.532)
`
`Hodge. J.w. 1995. carcinoembryonic antigen as a target for cancer vaccines. Cancer Immunol and lrnmunother
`431127-1341{Exhiblt 2032; Int. No. 104.532]
`
`I-luynh at al.. 1984. Constructing and screening cDNA libraries In lcgt IO and kgtl 1. DNA Cloning. Vol I- A practical
`Approach 49-78. Glover. D[EcIitor}. IRL Press. Oxford (Exhibit 2050; Int. No. 104.532)
`
`Jackson and Davis. 'Quantitatlon of lmmurtoglobullns.‘ Chapter 14 (pages 109-120) in Rose and Friedman. Manual
`of glinfi I Irnmunglggg. Second Edition {1980}
`
`Jefferis et al. 1998. lgG-Fc-mediated efiector functions: rnoleculardefinilion of interaction sites for effector ligands
`and the role at glycosylation. Immunological Reviews 163:59-76 (Exhibit 2095; Int. No. 104.532)
`
`Joziasse, et al.. 2000 '33-Gaiactosylated glycoprotelns can bind to the hepaticasialoglyooptotein receptor’ Eur. J
`Blochem. 26?':6501-6508 {Exhibit 1037; Int. No. 104.532}
`
`Kabat et al. Sequences of Proteins of lmrnunoloqlcal Interest. Bethesda. MD: National Institute of Health pipe. 1, mi.
`mi (1933)
`
`Kabat et al.. ‘Sequences oi immunoglobulin chains: tabulation and analysis of amino acid sequences of precursors.
`V-regions. C-regions. J-chain and [beta]:-mlcroglobulins ....."The Kabet Database oi Sequences oi Proteins or
`lmmunologicailntare-st.'1979. Publication No. 602008. p. 185. National institute of Health. Bethesda. MD.
`(GNE-MED 52580)
`
`Kaetzel et al. 1985. Expression of biologically active bovine lutelnizing hormone in Chinese barrister ovary cells.
`Proc. Natl Aoad sci USA 82:7280-7283 (Exhibit 2152; Int. No. 104.532}
`
`Y: J Biol Chem 1988 Nov 25:263(33):1?503-15 (Exhibit 1153; Int. No. 104.532)
`
`Kaufman el al. 1987. Goampiifimiion and ooexpresslon of human tissue-type plasminogen activator and rnurine _
`dihydrofolate neductase sequences in Chinese hamster ovary cells. Molecular and Cellular Biology 5:17.50-1759
`(Exhibit 2075; Int. No. 104.532}
`
`Kipnyanov at al. 1999. Generation of recombinant antibodies. Molecular Biotechnology 12:173-201 (Exhibit 2017;
`It'll. No. 104.532)
`
`some —_
`14-
`
`is in conformance with M.P.E.P. § 609. Draw line through citation it not in
`'|NER: Initial it refers -- -. dared. whther or not
`conformance am not considered. induce copy if this town with next cornrnunlcation to Applicant.
`oa:ocsra2'rse4.1
`
`8
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`INFORNIAWON DISCLOSURE
`STATEMENT 3* W”°i‘‘*”
`
`
`
`
`
`
`
`NON-PATENT LITERATURE DOCUMENTS
`
`’
`
`serial. symposiurn. catalog. lllc.}. date. pagetsl. volume-issue numberisi. publisher. dry andrcr country were published.
`
`Initials
`
`.
`
`Examiner. Includenameoftheauthor[inCAPITAL LETTERS}.titleofthearticle (wrrenappropriate).title oftheitem lboolt. rnagazlrre.journal.
`Kohler. G. Bioscienoe Reports 5:533-549 (1935) (Plaintiff Exhibit 1108. case No. ON S-00-1252WBS GGH}
`Krag at al.. J. Biological Chemistry. Vol. 257. No. 14, 9 8-424 (1983) (Ezdtihit 1115; Int. No. 104.532)
`-I Krag. J. Biol. Chem. 2543916?-91?? (1979) {Exhibit 1043: Int. No. 104.532]
`Krolick et al. 1932. In vivo therapy of a Murine B cell tumor (BCL I} using antibody-ricin a chain immunotoadns. J Exp.
`Med. 155:179?-1809 (Exhibit 2122: Int. No. 104.532)
`
`-
`
`Friedman. Manual cl’ Clinical Imrrrigy. Second Edition (1980)
`
`Kyle,‘Classificationand DiagnosisofMonoclonalGammopathiosfChapter 16(pages 135-150)inRoseand
`I. Levy.R. and RA Miller. 1983.Biologicalandclinicalimpliratlonsoflymphocyte hybridornas: tumortherapywith
`monoclonal antibodies. Ann. Rev. Med-34:10?-116 {Exhibit 2121: Int. No. 104.532)
`Liiely et al.. Glycobioloiitr. Vol. 5 No. 8: 813-822. 1995 (Exhibit 1170: Int. No. 104.532}
`Lingappa et al. 1930. Signal sequences for early events in protein secretion and membrane assembly. Ann.
`Nwtcad. Sci. 3-l3:356-61 (Exhibit 214?: int No. 104.532]
`-
`Linscotfs Directory {formerly Catalog) of Immunological and Biological Reagents. second edition 1982-83. pp. 1-57
`Lofluglioand Saleh,Am.J. MedicalSciences.Sept. 1992Vol. 304. No. 3. pp. 214-224 (Exhibit 1150: Int. No.
`LiuetaI.. ‘Expressionofmouse: humanirnmunoglobulinheavy-chaincDNAinlymphoidcells"Gene54{1}:33-40
`
`‘
`
`104.532)
`
`(1987)
`
`MD. Pegram at al.. ‘Antibody dependent cell-mediated cytotoxicity in breast ncer patients in Phase III clinical trials
`of a humanized anti-HER2 antibody“. Proc Am. Assoc. cancer Res.. 1997. 38:B02 (#-t044){Exl1|blt 2248: Int. No.
`
`Ma. S. and W. Nashabeh. 1999. Carbohydrate analysis of a chimeric recombinant monoclonal antibody by capillary
`electrophoresis with laser-induced fluorescence detection. Analytical Chemistry 71:5185-5192 (Exhibit 2145; Int. No.
`104,532)
`
`Maniatls. T.. E.F. Fricsch. and J. Sarnbroolr. 1932. Table of contents: ‘Extraction. Purification. and Analysis of MRNA
`from Eultaryolic Cells“. 187-209; ‘Synthesis and cloning of CDNA'. 211-246; and ‘Construction of Genomic
`Libraries’. 269-307. in Molecular Cloning A Laboratory Manual. New York: Cold Spnng Harbor Laboratory (Exhibit
`2008; int. No. 104.532}
`
`Marguiies et aI.. “Regulation of immunoglobulin expression in mouse myeloma cells‘ lmmunoglobuiin Expression pp.
`781-791 (1977) (GNE-MED 31462]
`-
`
`Marx, J. Science 229:455-456 (1985) (Plaintifi Exhibit No. 1118. Case No. CIV S-00-1252 WBS GGH)
`Martinis at al., ‘Monoclonal antibodies with dual antigen specificity!‘ Oncology pp. 311-316
`P-latsuuchi et al. 981. An analysis of heavy chain glyoopepiides cf hybrldoma antibodies: correlation between
`antibody specificity and sialic acid content. Journal of immunology 127{5):2t88-90 {Exhibit 2050: Int. No. 104.532)
`
`|sinccnformanceuithM.P.EP.§6D9. Drawlinetlrroughcllalionilnotin
`s--==-n=-
`.
`‘
`=
`=
`confcrrnsnce mgr, not considered. include copy ct this form with next comrnurrlcatlon to Applicant.
`ocoocsaezrssu
`
`
`
`9
`
`

`
`
`
`- «Ilcation Number
`Fmm Date
`INFORMATION DISCLOSURE
`STATEMENT BY AIPPLHCANT
`Hm Named Inventor
`
`-j Attorne Docket Number
`rt 333-10230
`
`
`
`
`
`
`
`NON-PATENT LITERAVU RE DOOUM ENT5
`
`.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Morrison et al. 1988. Production and characterization of genetically engineered antibody molecules. Clinical
`Chemistry 3-1l{9):1668-75 (Delendant Exitiblt 5009. case No. CW S-00-1252 was GGH)
`l1ilorrison,vS. Hospital Practioe 24(10):65-80 (1989) (GNE-MED 077476)
`.
`
`I. Morrison. 8.,‘Invitroantibodies: strategiesforproductionand appiition"AnnualReviewofinununotogy 1D:239- _
`
`
`
`265 (1992)
`
`.
`
`
`
`Mulligan. RC. at al.. ‘Selection for animal cells that express the Escheriolrla coll gene coding for xanthlne-guanine
`phosphoribosyllransierase." Proc. Natl. Acad. Sci. 78 :20?2-76 (1980)
`
` Munro. ‘Uses of chimeric antibodies.” Nature 312597 (1934)
`
`Noubergsr. M. rues 347-349 (1985) (Plaintiff Exhibit 1130 {Case No. cw soo.r252 was GGH)
`'
`
`Neuhaus Bl ai.. JACCt4:1566-1569{Novsmber15,1989){Exhii:1it1032;lnt. No. 104.532}
`
`Neumaier et al. Cancer Research 50:2128-213-1 (April 1, 1990) {Exhibit 1013: int. No. 104.532)
`
`Nose. M. and H. Wigzell. 1983. Biological signilioanoo of carbohydrate chains on monoclonal antibodies. Proo. Natl.
`Aoad. SOL USA 80:6632-6636 (Exhibit 2022; Int. No. 104.532]
`
`
`
`
`Oi at al.. 'immunogiobulin Gene Expressin in Transformed Lymphoid Cells.‘ Proo. Nail. Ad. Sci, Vol. 80. No. 3. p.
`B25-59 (Feb. 1, 1983}
`
`Di 8. Morrison BioTechniques 4(3):214-221 (1938) (Plaintiff Exhibit 1135. case No. CIV S-OD-1252 WBS GGH)
`
`IIFDldharn. R. 1983. Monoclonalantibodies inneartherapy.JournalofClinicalOncology 1:582-590(Exhibit2119:
`
`
`I.“ Drtila el al.. "lrnrnunoliuoresoenoe study of“non-idiopathic‘ renal amyloidosisf Horn. Pathoi- 14(-11:36:-'l' (1983)
`Peaitman at al., Hum. Antibod. Hyiarldornas 5165-74 (1994) {Exhibit 1038; int. No. 104.532)
`
`
`._._
`__
`. 3 ._ _._ ..
`_
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`Si
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`Considered
`r
`‘EXAMINER: Initial ll reference considered, who -= or
`-- citation is in oonlorrnanoo with M.P.E.P. § 609. Draw line than citation it not in
`oonlorrnanoe and not oonsirlsrod. Include copy ol this form with next oornrnunioatlon to Apflinant.
`DCDOCSl“62i'59ll.1
`
`
`
`Int. 104,532)
`
`
`
`10
`10
`
`Includenameoftheauthor(incapmu. LE‘|'l'ERs).li1laoithe article {whenallllmvriatel.titleorthe item(book. magazine,journal.
`Meredith at al.. J. Nuol. Med. Jan. 1992. 332329 {pp 13-19)
`Meredith et ai.. J. Nucl. Matt. V0133. No. 9: 1515-1653. Sept. 1992
`Meredith. et aI.. Hurn. Anlibod. Hybridomas. 1993. 4:190-19? (Exhibit 1033: Int. No. 104.532)
`Miles Biochemicals 1979-50. p. 14o-142
`Miller at al. ."l'ransfection of human lymphoblastoid calls with herpes simplex viral DNA.‘ Pros. Natl. Acad. Sol.. Vol.
`76. No. 2. PD. 949-53 (Feb. 1979)
`
`
`
`Initials
`
`No.
`
`serial. symposium. catalog. ate). data. panels). volume-issue numberls). pubfisher. city andlor oountnr where published.
`
`
`
`
`
`
`
`Morrison SL. etal.. ‘Amousernyaiomavariantwithadefectinlightchainsynthesis.“Eur.J.lrnrnunot. &461435
`
`II Morrisonelal. 1988. Geneticallyengineeredantibodymolecules: newtoolsforcancertherapy. CanoerInvestigation
`
`
`
`
`Moreil el al. 1971. The role of sterile acid in determining the survival of glyooprotelrls in the circulation. J Biol Chem.
`2-16:1-161-1-167 (Exhibit 2117: |nL No. 104.532)
`
`(1979)
`
`
`
`6{2}.'185-92 (Exhibit 2085: Int. No. 104.532)
`
`

`
`
`
`
`
`rr ti
`N
`b
`Fmn°;a;" W‘ ‘"
`Hm Named Inventor
`
`v- Tutelorlcn-rntu9NPT06I4498IP1’O
`
`
`
`
`
`INFORMATION ISCLOSURE
`STATEMENT BY APPILIICANT
`
`
`
`Emlilljrij Marne Docket Number
`338-10230
`
`NON-PATENT LITERATURE DOCUMENTS
`
`
`
`serial. symposium. catalog. etc). date. page(s). volume-issue number(s). publisher. city andlor country were published.
`
`Include nameoftheauthor(inCAPTTAL LETTERS).titleotthearticle (whenappropriate).title olthe Item (book, magazine.journal,
`Page et al., Biotech, 9:64-68 (1991)
`Picard et al.. ‘Correct transcription of a cloned mouse immunoglobulin gene in viva.‘ Proc. Natl. Ad. Sci., Vol. 80,
`pp.. 417-21 (Jan. 1983)
`
`
`
`Initials
`
`No.
`
`
`
`
`Potamlanos et al. 2000. "Radio|mmunosclntigraphy and Radioimmunotherapy in Cancer: Principles and Application.
`Anticancer Research 20, 925-948 (Exhibit 2185; Int. No. 104,532)
`
`
`
`33(3):741-748 (Jul 1983)
`
`
`
`
`
`
`
`
`
`
`Primus et al., Cancer lmmunol. lmmunotherapy (1990) 31 :349-357 (Exhibit 1164; Int. No. 104,532)
`Queen and Baltimore. "lmmunoglobulingenetranscriptionisactivated bydownstream sequenceelements"Cell
`Queen. C. ‘Comparison of mouse and human V-kappa domains’ (submitted by PDL 3/27/1997)
`Queen, 0., “Comparison of human and mouse VH domains” (Submitted by PDL on 3/27/1997
`
`Rademacher et al. (1988) Ann. Rev. Biochem. 572785-838 (Exhibit 2165; Int. No. 104.532)
`
`Raju et al. 2000. Species-specific variation in glyoosylation of I96: evidence for the species-specific sialylation and
`
`
`
`
`branch-specific galactosylation and importance for engineering recombinant glyooprotein therapeutics. Glyoobiology
`10(5):477-486 (Exhibit 2027; Int No. 104.532)
`-
`Reff et al.. Blood, Vol. 83. No. 2. pp 435-445 (1994) (Exhibit 1111: Int. No. 104,532)
`
`
`Renner et al. 1997. Monoclonal antibodies in the treatment of non-Hodgkin's lymphoma: recent results and future
`
`prospects. Leukemia 11(2):S55-S59 (Exhibit 2019; Int. No. 104.532)
`Rhodes and Birch Biotechnology 6:518, 521. 523 (1988) (Exhibit 1046; Int. No. 104,532)
`Rhodes, Adv. Anim. Cell. Biol. Technol. Bioprocess.. 472-74 (1988) (Exhibit 1045; Int. No. 104.532)
`Riechmann et al. 1988. Expression of an antibody Fv fragment in myeloma cells. Journal of Molecular Biology
`203(3):825-8 (Exhibit 2087; Int. No. 104,532)
`
`
`
`Riechmann etal. 1988. Reshaping humanantibodies fortherapy. Nature3221323-327 (Exhibit 1022; Int. No.
`
`104.532)
`
`
`
`
`
`
`Rosen et al. 1983. Application of monoclonal antibodies to tumor diagnosis and therapy. Annals of Clinical and
`Laboratory Science 13:173-184 (Exhibit 2120; Int. No. 104.532)
`Routledge et al.. Eur. J. lmmunol. 1991. 21:2717-2725 (Exhibit 1068; Int. No. 104.532)
`Schein et al.. "Formation of Soluble Recombinant Proteins in Escherichia coli
`is Favored by Lower Growth
`
`
`
`
`Temperature” BloTechnoloqy 6:291 -294 (1988)
`Schein. Catherine H., “Production of soluble recombinant proteins in bacteria‘ Bio/Technoloqy 721141-1149
`
`
`
`
`l
`
`Sekigawa et al.. J. Virology 6425194-5198 (October 1990) (Exhibit 1056; Int. No. 104.532)
`Sheeley et al.. Analytical Biochemistry 247, 102-110 (1997) (Exhibit 1096; Int. No. 104.532)
`
` , L
`‘EXAMINER: Initial it reference considered. whther or not tion is in conlormence with M.P.E.P. § 609. Draw line through citation it not In
`conlorrnence mg not considered. Include copy cl this lonn with next communication to Applicant.
`DCDOCSl627594.1
`
`Q
`
`11
`11
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`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`
`
`
`
`
`
`Emiiflmjj ettnrne Docket Number
`
`
`
`
`233840230
`
`-
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS). Elle oi the artists {men appropriate). title at the item [book magazine. journal.
`serial. symposium. cataiog. etc). data. pagete). volumetssue numberts}. publisher. city andior country where published.
`
`Sldman. C. 1981. Differing requirements for glyoosylation in the secretion of related glyooproteins is determined
`neither by the producing cell nor by the relative number at oligosaocharide units. Joumal at Biol. Chem.
`256{1B):937-1-9376 {Exhibit 2100; Int. No. 104.532)
`
`Solomon. “Hence-Jones Proteins and Light chains of irnrnurtoglobulinsf Scand. J. lmmunol.. Vol.5. 585-895 (1976)
`Southem. PJ et at. "Transformation of mammalian cells to antibiotic resistance with a bacterial gene under uantrol of
`the SV40 earty region promoter.‘ J. Mo1ec.Appt. Genet, 1:327-41 (1982)
`
`Spellman et al.. 1989. J. Bio. Chem. 264:14100-14111 (Exhibit ‘I151; Int. No. 104.532)
`StaitordandQueen.‘Cell-typespecificexpressionof atransfected immunoqlobulin qene'Nature30E-(5938)-77-79
`
`(Nov 3. 1983)
`
`Stevenson et al.. 1999. A Chimeric Antibody with Dual Fc Regions (b!sFabFo} Prepared by Manipulaliens at the lgG
`Hinge. Antiocancer Drug Design 3. 219-230 {Exhibit 2182: int. No. 104.532)
`
`Stevenson et al.. Blood ?7:10'r'1-1079 (March 1. 1991) (Ethiblt 1026: Int. No. 104.532)
`Summers el al.. ‘Stable expression in mouse cells of nuclear neoantigen alter transfer of a 3.4-megadatlon cloned
`fragment oi Epstein-Barr virus DNA.‘ Proc.. Natl. Acad.
`Vol. 79. pp. 5638-92 (Sept. 1982)
`
`Sun et at. 198?. Chimeric antibody with human constant regions and mouse variable regions directed against
`carcinorna-associated antigen 17-IA. Proc. Nat! Atrad. Sci. 8-t(t)214-9 (Exhibit 2080: Int. No. 104.532)
`
`I. T.E. Hotalingat al..“The humanized anti—HER2 antibody rhuMAb HER2 mediates antibodydependent cell-mediated
`cytotoxiclty via FcyR III‘. Proc. Am. Assoc. Cancer Res.. 1995. 37:471 (#3215)
`Talteda et at. Nature a14:452-454 {19B5}(PieintiftExhibit 1171. Case No. cw s-oo-1252 was GGH}
`Talteietat. 1980. MonoclonalantibodyI-i9l25reactswithfunctionalsubsetsof1'and Bcells: killer. hitterprecursor
`Takeuchl at al.. J. Biol. Chem. 263:3857-3663. {Exhibit 1152; lni. No. 104.532}
`Tan et al. 1995. A human-mouse dtimetic In lrnmunoglobulin gene with a human variable region is expressed in
`mouse myalorna oetts