• INTERNATIONAL SEARCH REPORT
`
`lnter11•tlo.,•I .Aocillctuo" No PCT/US89/05857
`I , CL.A881,,CATION Of DUBJKCT MATTlft Ill uveral CltUlf1c1tton 1ymbo11 apply, indicate all) l
`
`II. FllL.D8 8EA"CHCD
`
`,.
`
`M1r1lmum Oocume111011011 Searched •
`_e_1_•_•_•i_r._ca_1_1o_n_s_,_•_1•_m__.l:---------------------~C-l•_•_•_lfl_c_1_11_o_n_s_y_m_b_o_I• _____________________ __
`U.S.
`530/387; 424/85; 435/69.1,172.3; 536/27; 435/240.l
`
`----------------------------------·-·
`
`Cocumentellon 8a1rched other than Mlnlmotm Documentation
`to ll'lt £ttent tllat """ Docurnentl are tn"1.1d•d In the fleld• 5oarc11eis •
`
`··.
`
`Ill. DOCUMCNTS CONSIDUUD TO ai; IHUVANT 1•
`Cete11ory • !
`~-------------------------~-
`-
`C It a U on ot Document, •~ w11n lnclleauon, •11ue 1pproot11tt, of cne re••••nt Pl•HO•• 1 r
`1 Rele•1n1 10 c1a1"' No. 1 •
`- ------
`
`Y,P
`
`US,A
`
`Issued
`(CABILLY ET AL)
`4,816,567
`28 Ma?:ch 1989, See entire document.
`
`.
`Issued 30 September 1987 ;
`!
`, .
`
`1-22
`
`18-22
`1-17
`..
`
`18-22
`1-17
`
`1-22
`
`i
`
`'
`i
`!
`' I
`
`x
`y
`
`X.J:
`y
`
`x
`y
`
`I EP,A
`..
`
`WO,A
`
`239,400
`(WINTER)
`See entire document.
`..
`Is&UE!d
`( BODMER El' AL)
`89/01783
`09 March 1969, See entire document.
`
`GB,A
`
`'' ·:
`
`I
`
`'
`
`2188941
`Issued
`(DIAMANISTEIN EI AL)
`14 October 1987. See entire document •
`...
`Science. Volme 238 Issued ··20 November 1987
`(VITETI:A Et AL) "Rede.signing 'nature's poisons
`create anti.-tunor reagents" • pp 1098-1104.
`See entire document.
`
`to
`
`• 8pec11t cllegoriH al c ited dacum•nta; ' '
`. .. ,... document 11enn1n11 tho eene,.I etet• of 11'1• 8't wl'llcn I• not
`ce,.eloereo to be ef 1ut1c1110r t•l•••nce
`·1• • ., ... , .S1Kument 11ut 1>ut1111nac1 on or altar tne lntern111onal
`flllnt •et•
`•L. • document wntch may tl\row doll Ille on prlorUy c la1mc1) or
`whleh I• 01tad lo eelebllel\ Iha pullllcatlon dete ol e1101her
`CllltlOf\ or other epeclal r•••on (•• epecllled)
`•o• doaarment referring to •" orel cu1clo•11re, 11••· a•11111111011 or
`otllet moan•
`.
`. ... ·
`.
`• ,.. dM1.1ment 11ullllahed prior to th• l11ttrn1t1ofl1t tlllno date bu.1
`Iller Chan tl'le arlarll1 d•I• clalm•d
`
`IV. CIRTIFICATION
`D•l.8 •f the Ac;tual Comple11011 of Illa 111 .. rnallonal S.ucl'I •
`.. ..
`-
`01 June 1990
`lnl.8m•Uan1I a..,1:111no A utl'lortty •
`
`ISA/US
`Porm PCT/ISA/21D I.._,., ehff!) (Mey 11891
`
`(con't)
`•r• leter document isubll•he• •h•r the lnter11•1tonel flhno d•t•
`or oriorit,, d•I• and not In col\fllcl will\ Iha eoohcelion llul
`clttd to und•ratend Iha prl11ciol• or tl'l•O'Y 11notrly111a 1110
`1n .. an11on
`•x• eeeument of 111r11eutu ••leva11c•: tfte c•••"'•d 1n.,en11on
`c1nno1 be conetderect no•el or · c•n"ot be con•lderell to
`1nwo1.,. an lnventlwe 1te11
`·v~ 11oc11mont al p1rtlcwter rele•1nc•t the cltlm•d ;11.,e111ion
`cannot oe cone111ertc1 10 ln•olw• • " 1n . . !\llvo 1101> wnen t'lo
`oocu,..a111 lo comllinad w ill\ on• or "'ore other • .,.,,. isocu·
`menl•. •uch eomblMllon 11011111 ell•lou• to • per•an •~ill•d
`In ll'I• ere.
`.
`, .
`• ,. 11ocu1'\0nt meml>er of the eamo 0110111 lemlly
`
`•:
`
`! D••• of Ma1111111 of thl• 1nw1na t1o na 1 :uareh Repon •
`02JUL1990 .
`' I
`~~atur• ol Aut11or11e111 ~··. • d
`I-Michelle Mark~
`.
`
`346 of 1033
`
`BI Exhibit 1002
`
`

`

`WO 90/07861
`
`• ••
`
`.,./US89/05857
`
`7/ 8
`
`A
`
`HUT-102
`IOOO~----------
`
`B
`IOOO~----H_UT_-_10_2 ___ _
`
`~ j\
`: i . :
`\
`~:
`
`:
`' :
`
`~
`
`;
`
`I
`
`' -
`
`HUMANIZED ANT I-TAC
`
`ANTI-TAC
`
`c
`JURKAT
`1000....-----------
`
`D
`
`JURKAT
`IOOO - - - - - - - - - - -
`
`. '
`
`FIG.-9.
`
`347 of 1033
`
`BI Exhibit 1002
`
`

`

`WO 90/07861
`
`./US89/0S857
`
`. ( ,
`
`A
`
`;"'"
`
`\ .
`
`B
`
`' '• ,,
`
`8/8
`
`···-·- ·-··-··--
`
`0 NG ANTI-TAC
`10 NG
`20 NG
`40 NG
`
`0 NG ANTI-TAC
`20 NG ANTI-TAC
`20 NG HUMANIZED ANTl·TAC
`
`FIG._JO.
`
`348 of 1033
`
`BI Exhibit 1002
`
`

`

`U.S. DEPARTMENT OF COMMERCE· Pau:n1 and Tndcnr.rt Office
`
`NOTICE OF ORAFTSPEll.SON'S PATENT ORA WING REVIEW
`
`PTO Draftpcrsons n:view all originally flied drawings regardless oC whc1her I.hey nre designated as fonnal or infonnal. Addiuonally,
`patent Examiners will review the drawings for compliance wilh the regulation.~. Direct telephone inquiries concerning this review to
`the Dr.iwing Review Branch. 703-305-8404.
`
`Tiic~ruw·ug<filcdli~datc)_tJ fL
`
`. .~
`
`nm objcc1ed to by the Diat;/;/sr ,
`er J7 CFR 1.IW<it I. I !12.
`A._
`. ob)cctcdtohylhcDr.lflspmooundd37CFR t.84 nr l.IS2~•
`B.
`indl
`ktw. The ~1incr wlll rcquin: subrni>Sion ol new, com:crnl
`e1
`cllawinp when nc.c:cuary. Currcc1cJ drawings m"'' be wbmiucJ
`aa:ordina to U>c instructions on the back ot itu. NOllc:c.
`
`L DRAWINGS. 37CFR l.8-1\1): Ac<"tpl3blC~ccuticsor.1r:1wings:
`Block in.I.. c;,,1,,,..
`_ Nut !>lac.le: •olitl lines. Fl~(J) _____ _
`_ Color dra"ings :ire Ol~ ill:.:Cf'lahlc un1il flClilion I< "1J'llcd.
`
`2 PHOTOORAPHS. 37 CFR l.S4(bJ
`_ Phol<>graplu .,.. 1101 ... ..,cpablc urnil rc1itioo i! gnn1td.
`
`3. GRAPHIC FORMS. 37 CFK 1.84 tdl
`_ Chcmlcnl or malhcmallc::ll rormuJ• Olll lai:>tlcd as ~flln!• figun~
`Fl~(,), ____ _
`_ Group or wovcfnnm not ptc,<entcd .., a single r.,un:. u.d11g
`co1JUuon vertical :I.Xis wuh lime extt:ndin& alung bcJn1on1·a.1 Ui)_
`A&(•l·- - - -
`Individuals wavcroon ooc ill<nlifial with • scJ'3'1lt lt11U
`cJcil1n.Uon l!ldj:><Xm In lilt vertical a.tis. Ag(<). _____ ,
`
`-
`
`"· TYP6 OF PAPER. 37 en l.iS4(c)
`Paper Ml nc>.iblc, •trong, while, s111wll>, n<mSlliny, and durdblc.
`_
`Shccll1) _____ _
`_ En.1uns. alca.Uoni. o~cln&~ illlcrlinealians, eta<'ks. crcnsr'1.
`and folds oot allowed. Shtclt•>·--- - - -
`~- SIZE OP p /\PER. 37 CFR 1.114(1): ll=pcublc P•r•uiics:
`21.6 ~m. by 3$.6c111.1R112 by 14 inches)
`21.6 rm. by JJ. I cm. (8 112 by 13 lndl<'S)
`21.6 cm. by 27.9 en~ t8 112 by 11 inches}
`21.0 cm. by 29.7 cm. (DIN <izc 114)
`All clla'4'W' shccL< oot 11\c Slllllt <l:r.e. Shtc1\s) ____ _
`Onwing ~ not an acccpcOlble site. Sl1«t(•) - - - - -
`
`1.
`
`b)
`REMINDER: Specifk~lon may rcqul~ m-•sfon ltl corrc.'pood m
`drawing cllangcs.
`All views me grouped coecth<r. Fi&(s) _____ _
`_
`VitWli amncacd by pmjcClion lines. Fig(s). _____ _
`_
`Views ooncain ccnlt.r lina. l'i¥(1) __ __ _
`_
`Partial view~. 37 CF1I t .84\h)(2)
`ScJ'IU"IO •httlS""' linked cJgo 10 edge.
`Fig(•l· - - -- -
`Vlcw :inU enlorgtd view Olll labclctl sepv:11cly.
`fl&(•>·--- - - -
`~~ic.w rclilllamhir bc1,.ccn diffemu paru oot dear llPll
`unambiguout. J7 CFR l.ll4(1t)(2)(ii)
`Fig(•l·- - - -- -
`Secuooal views. 37 CFR l.1141h)(3)
`H:11cllln& noc indic111ct1 for ~looal (>Onion.< nl 1111 objc.:1.
`Fi&(s). _ _ ___ _
`Haidllng ol rqutmy spoc<d ohlique ponllld lines Mt lp:nd
`suJ'Ocicnlly. Fig(•~-----
`HJSclling OOl ;a subs11111ial angle to 5W1Wlldin: ..cs"' !lrincip;~
`lillC$. Fi&(•>------
`Cross Retioo no.I druwn SIUllC. us view \NhJ1 pans in CfOSS scCliUfl
`w\111 "~utttrly ql:ll"td panlld <iblique stmi.:.:..
`Flg(s) ____ _
`HllL'bing or juxlaflOSCd d\Hcmtl ekmcnts noc uncled in a dilfcmm
`way. A&(s.,_ _ _ __ _
`Ahtma!ellOliOOn. 37CFR l~hM4 t
`_
`
`F;~(ll ___ __ _
`
`A ...,,....c. \Oew n:quiml f0< o moved rnsuiou.
`IZ
`
`ATTACHMEITT1vPAPER NO.
`
`Modified form, 37 CFR 1.84(b)(S)
`M11dlr.ed f(lnl.- of coosttualoo lllWif be sho-.11 in S<p:itWC views.
`Fig(sl _ __ _ _ _
`
`~ ARRANGEMENT OF VIEWS. '31 CFR 1.S4cl)
`V"iew rl:iccd """"onochc.r view (Jf .. ill>in nutlinc nr m10lha
`Figt.o. _____ _
`Wonb do OOl "llf'Cllr in a ltorirnnull, lef1-10-righ1 "''hiOn whCJl
`pogc is citl>cr urrighl or IUmcd Ml lhlll lhc IUI> beC0"1C.< Ille riChl
`side. cacq>l fa< t;r.llJlu.. Fig(s). ____ _ _
`
`9. SCl\LE. 37 CFR 1.114(~}
`
`Scale noo lorgc coough 10 '"°"' 111<eh.1ni<m wi!Mul cruwJinc
`
`whco dr•"'inl: is reduced in st1.e 10 cwo-thirds in repn)Jucoon.
`Fog{sl _ __ __ _
`lndie11uun well"' "actual oi>A>" ()r "1calc 112" nol (lCnnincJ.
`Fi2(>) ____ _
`EJcmtnL< (I(~ view nm In fll'OP<lltlon 10 each Olhtr.
`Fig(s) __ ___ _
`
`10. Oll\Rl\CTER OF LINES, NUMBERS. lit. LETTERS. 37 CFR 1.84(1)
`Lina. numllctl; & lellttl ooc uniformly lhiclc an<! well dd"uicd.
`_
`clCUI, dumblc, und 1>12<:k (CACCpl for COier cllaw""').
`Re<•>------
`
`11. SHADING. 37 CFR l.84(ml
`Sltafui& ... cc1 fm Dllttt lhal1 shepc.ol' spbcrical, cyllncltialJ, und
`ooo1e11 ctancnu or an obj«t. or ror na pans.
`Fig(~.~-----
`Soli<l bl:tek sh:Wing are:l.I llOI rocnn!Ucd. Fig{s._ ____ _
`
`12. NUMBERS, t.mnRS. & REFERENCE CHARACTERS. 37 CFR
`l.Sil(p)
`Nuntbcis W>cJ .. r= ch:>rllclcn not plain 1IDd tcgibl<. 37 CFll.
`1.~p)(IJ FigCs). ____ _
`Numbc11 and rdC1Cl>CIC Clline1eri U.'4:d in ainjuctlon with
`nkcts. Ul\'Cr1UI comm:is. Of Gnclosai "ilhin Ollllioa. 31 CFR
`l.84CpXI) Fig(s). ____ _
`Numher$ and rcfenmcc cbara:lnl not oricnled in '"""" direction a.<
`lhc view. 3'7 CFR UW(p}\I) Fi&{s).__ _ ___ _
`Engli<b alphabclDot used. 37 CFR I .84(p)(2)
`Fig(1). _____ _
`Numbers. tcucrs. incl rc:fCttJU ch3rec1£11 ll0 DOI measure DI !em
`.32 cm. (1/11 hldl) in bclgl\l. 31 ()'11.(p)(J)
`Fig(•>·- - - ---
`
`13. LEAD LI1'ES. 31 CFR 1.IW(ql
`Lead wie. c:mss elldt other. Fig(sJ _____ _
`_
`LeaJ liou missing. Fig\sJ _ __ __ _
`_
`Lclld lines""' u ohQn as po»ibk Fig(•------
`_
`
`., LMBERINO OF SHEETS OF DRAWlNfiS~,.c;FR 1.84<•)
`~~umber "R'C"" in wp =rgln. Fl&('>/.+¥--
`Numl1Cf nol Larger llwt rcfet'Clla: chariiCI'".
`-
`Fi'(I) _____ _
`Sh«ll not numN:rtJ coruecutivcly, and ill Ar.tbic numcralt.
`bcgiMinc with ownbcr I. Sbccll•>·-- - - --
`
`IS. ~UMBER OF VIEWS. 31 CFR 1.84(u)
`Views Ml aumhCftd consccull•·cly, and in Arabic numerals,
`begiMiJ1& will> nwnbcr I. Fig(~l------
`Vicw u<W11'c1l POI pn:cxdcd by Ille abbrt:vjulion Fig.
`Fig'(s). __ __ _
`Sin&le view r::oo~ns a ~· ... numb« and lhc obbrcvi111icn Fi&.
`_ Nwnbcr> noi ~: c=cc dwat1en.
`Fig(•)
`'
`
`l.ll4(w1
`16. CORRECTIONS. 17
`ComoctlMS llOC dllr11blc llnd pcnnancnl. Fi;(s.,_ __ __ _
`_
`
`17. DESIGNDRllWING. 37CFR l.ISl
`Surf:icuhorling>holm no1 ~lie. FitC•>·----- -·
`Sulld bl:icl< ohad'utt..,. ...... Tor cnlor CM<n)L
`Fig(1) _____ _
`
`349 of 1033
`
`BI Exhibit 1002
`
`

`

`•
`
`•
`
`PATENT DOCKET P
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of
`
`Carter and Presta
`..
`1
`Serial Nd~. 08/146,206
`
`Filed: 17 November 1993
`
`For: METHOD OF MAKING HUMANIZED
`ANTIBODIES
`
`Group Art Unit: 1801?~
`Examiner: ADAMS_11p.
`r.." ,,.,~
`
`. "
`
`INFORMATION DISCLOSURE STATEMENT
`
`Honorable Commissioner of Patents
`and Trademarks
`Washington, D.C. 20231
`
`Sir:
`
`Applicants submit herewith patents, publications or other information (attached hereto and listed
`
`on the attached Form PTO-1449) of which they are aware, which they believe may be material to the
`
`examination of this application and in respect of which there may be a duty to disclose in accordance
`
`with 37 CFR § 1 .56.
`
`This Information Disclosure Statement:
`
`(al [)
`
`accompanies the new patent application submitted herewith. 37 CFR § 1 .97(a).
`
`lb) []
`
`is filed within three months after the filing date of the application or within three
`months after the date of entry of the national stage of a PCT application as set forth
`in 37 CFR§1.491 .
`
`(c) CJ
`
`as far as is known to the undersigned, is filed before the mailing date of a first Office
`action on the merits.
`
`(di [x) is filed after the first Office Action and more than three months after the application's
`filing date or PCT national stage date of entry filing but, as far as is known to the
`undersigned, prior to the mailing date of either a final rejection or a notice of allowance,
`whichever occurs first, and is accompanied by either the fee ( $ 21 Ol set forth in 3 7 CFR
`§ 1. 17(p) or a certification as specified in 37 CFR § 1. 97(e), as checked below. Should
`any fee be due, the U.S. Patent and Trademark Office is hereby authorized to charge
`Deposit Account No. 07-0630 in the amount of $210.00 to cover the cost of this
`Information Disclosure Statement. Any deficiency or overpayment should be charged
`or credited to this deposit account. A duplicate of this sheet is enclosed.
`
`350 of 1033
`
`BI Exhibit 1002
`
`

`

`..
`
`. ,
`
`•
`
`08/146,206
`
`Page 2
`
`(e) []
`
`is filed after the mailing date of either a final rejection or a notice of allowance,
`whichever occurred first, and is accompanied by the fee ( $130) set forth in 37 CFR
`§ 1.17(i)( 1) and a certification as specified in 37 CFR § 1.97(e). as checked below. This
`document is to be considered as a petition requesting consideration of the information
`disclosure statement.
`
`[If either of boxes (d) or (el is checked above, the following "certification" under 37 CFR
`
`§1.97(e) may need to be completed.] The undersigned certifies that:
`
`D
`
`[]
`
`Each item of information contained in the information disclosure statement was cited
`in a communication mailed from a foreign patent office in a counterpart foreign
`application not more than three months prior to the filing of this information disclosure
`statement.
`
`No item of information contained in this information disclosure statement was cited in
`a communication mailed from a foreign patent office in a counterpart foreign application
`or, to the knowledge of the undersigned after making reasonable inquiry, was known
`to any individual designated in 37 CFR § 1.56(c) more than three months prior to the
`tiling of this information disclosure statement.
`
`A list of the patent(s) or pubfication(s) is set forth on the attached Form PT0-1449 (Modified).
`
`A copy of the items on PT0-1449 is supplied herewith:
`Cxl each [) none (] only those fisted below:
`
`Those patent(s) or publication(s) which are marked with an asterisk ( •) in the attached PT0-1449 form
`
`are not supplied because they were previously cited by or submitted to the Office in a prior application
`
`Serial No. , filed and relied upon in this application for an earlier filing date under 35 USC § 120.
`
`A concise explanation of relevance of the items listed on PT0-1449 is:
`
`[x)
`
`not given
`
`CJ
`
`[)
`
`[]
`
`given for each listed item
`
`given for only non-English language listed item(s) {Required)
`
`in the form of an English language copy of a Search Report from a foreign patent office,
`issued in a counterpart application, which refers to the relevant portions of the
`references.
`
`The Examiner is reminded that a "concise explanation of the relevance" of the submitted prior
`
`art "may be nothing more than identification of the particular figure or paragraph of the patent or
`
`publication which has some relation to the claimed invention," MPEP §609.
`
`351 of 1033
`
`BI Exhibit 1002
`
`

`

`. .
`
`08/146,206
`
`Page 3
`
`While the information and references disclosed in this Information Disclosure Statement may
`
`be "material" pursuant to 37 CFR § 1 .56, it is not intended to constitute an admission that any patent,
`
`publication or other information referred to therein is "prior art" for this invention unless specifically
`
`designated as such.
`
`In accordance with 37 CFR §1 .97(b), the filing of this Information Disclosure Statement shall
`
`not be construed to mean that a search has been made or that no other material information as defined
`
`in 37 CFR §1 .56(al exists. It is submitted that the Information Disclosure Statement is in compliance
`
`with 37 CFR § 1.98 and MPEP §609 and the Examiner is respectfully requested to consider the listed
`
`references .
`
`A copy of a document pursuant to 37 C.F.R. § 10.9(b) is attached as proof of the authorization
`
`of the undersigned to prosecute the above-mentioned application. The original of this document is on
`
`file in the Office of Enrollment and Discipline.
`
`Dare: April 13, 1995
`
`460 Pt. San Bruno Blvd.
`So. San Francisco, CA 94080-4990
`Phone: (415) 225-1994
`Fax: (415) 952·9881
`
`352 of 1033
`
`BI Exhibit 1002
`
`

`

`. I
`
`"" FORM PT0· 1449
`
`U.S. 'Dept. of Commerce
`~~~\.. R~
`LIST OF DISCLOSURES CITED BY APPLICAtf 37 APR
`I
`(Use several sheets if necessary)
`\~ 1995 JI!~
`"\:.!alDE~~TENT DOCUMENTS
`
`and Trademark Office
`
`-
`
`.. 17
`
`Atfy Docket No.
`· P0709Pl
`Applicant
`Carter and Presta
`Filing Date
`17 Nov 1993
`
`of
`
`4
`
`Sheet 1
`Serial No.
`08/146, 206
`
`Group
`1806
`
`Document Number
`4,816,567
`
`Date
`28 , 03 . 89
`
`Cabilly et al .
`
`Name
`
`Subclass
`Class
`\~o ?9'7.3
`
`Filing Date
`
`FOREIGN PATENT DOCUMENTS
`
`:xaminer
`niti~s
`~·
`
`l
`
`Examiner
`nitials
`
`Document Number
`
`Date
`
`I i,,'
`
`10 ?"lQ · - -
`
`2
`~ 0 620 276
`WO 89/01783
`WO 89/06692
`-- -
`... - - ........ -.
`
`r
`
`-
`···-
`.fl
`~ ~ ..s.
`- ~ WO 91/09967
`-
`-a-
`
`WO 92/22653
`WO 93/02191
`
`Country
`
`Class
`
`Subclass
`
`-
`
`-
`
`.
`
`Translation
`No
`Yes
`
`-
`
`---
`EPO
`PCT
`PCT
`---
`
`PCT
`
`PCT
`PCT
`
`" ' nQ 87
`' 19.10.94
`09.03.89
`27.07.89
`- - ...............
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`ll.07.91
`23.12.92
`04.02.93
`
`I
`
`~
`
`1~
`'
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`iv
`
`'1
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`:J.2
`
`OTHER DISCLOSURES (Including Author, Title, Date, Pertinent Pages, etc.)
`Arnzel and Poljak, "Three-dimensional structure of immunoglobulins" Ann Rey Biochem 48:961-967 !1979)
`
`Bindon et al . , "Human monoclonal 1gG isotypes differ in complement activating function at the level of
`C4 as well as Clq• .r1:nu:nal gf i::·l!J:21u:im!ii:ntal M!ii:d.i!::ill!ii: 168(1) :127 - 142 (July 1988)
`
`I... ee al., "l'rodu•ction of {i.mceional chimaeric mouse/human antibody • ~ 312(5995):643-
`Boulianne, G.
`646 (December 1984)
`
`~13
`
`Brown et al. , "Anti-Tac-H, a hw~anized antibody to the interleukin 2 receptor, prolongs primate cardiac
`al l ograft survival" fi:.:2c N~tl. 8cag, :Zci, l.!:Z8 88:2663-2667 (1991)
`-- - -14 ~ (erratum to article in N•ature 335 (6190): 564-568 and) 336:266 11988)
`
`Bruccoleri, "Structure of antib1ody hypervariable loops reproduced by a conformational search algorithm"
`
`15
`
`---- ,16
`
`-=- 17
`
`Bruggemann, M. et al., "Compari.son of the effector functions of human immunoglobulins using a .matched
`set of chimeric antiboq~,es" .I2l.l:Clal gf ~e~imental Mecicine 166:1351-1361 (1987)
`
`Burgess et al. , "Possi.ble Disso•ciation of the Heparin-binding and M1togen1c Activities of Heparin-
`binding !Acidic Fibroblast) Growth Factor-1 from Its Receptor-binding Activities by Site-directed
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`Carter et al . , "Humanization of an anti- pl851fEll2 antibody for human cancer therapy" Proc , N~tl .
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`
`..
`
`18
`
`Cheetham, J.' "Reshaping the antibody· combining site by CDR replacement-tailoting or tinkering to fit?"
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`
`Chothia and Lesk, "Canonical St:ructures for the Hypervariable Regions" J.' MQJ.. BiQl, 196:901-917 (1987)
`
`·19
`
`20
`
`Chothia et a l. , "The predicted :structure of immunoglobulin Dl.3 and its comparison with the crystal
`structure" s!;.i§lni::;!i;l 233:755- 758 (Aug. 15, 1986)
`"
`ILj/l>
`,,_ -
`,
`·Examiner: Initial if reference considered, whether or not citation is in confonnance with MPEP 609; draw line through citation
`if not in conformance and not considered. Include co:py of this form with next communication to applicant
`
`Examiner
`
`I Date Considered 1t1)s);
`
`USCOMM·DC 80·398.
`
`-
`,-=. .,.,;=:=; -
`
`'
`j
`
`353 of 1033
`
`BI Exhibit 1002
`
`

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`
`FORM PT0-1449
`
`LIST OF DISCLOSURES CITED BY APPLICANT
`(Use several sheets tt necessary)
`
`i
`U.S. Dept. of Commerce
`
`Patent and Trademar1< Office
`
`Atty Docket No.
`P0709Pl
`
`Applicant
`Carter and Presta
`Filing Date
`17 Nov 1993
`
`.. Sheet 2
`
`of 4
`
`OTHER OISCLCISURES (Including Author, litle, Date, Pertinent Pages, etc.)
`Chot.hia. c . et al . , • conformations of immunoglobulin hypervariable regions • N.a.t..uI:e. 342(6252) : 877- 883
`(1989)
`
`I Serial No.
`I Group
`
`08111-fd,0.,6a n ; ...... ~
`U'J~~ ~~Hu:.~'-' lldl
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`I 11·1. 1 1
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`21
`
`22
`
`23
`
`24
`
`25
`
`26
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`27
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`28
`
`29
`
`30
`
`31
`
`32
`
`33
`
`34
`
`35
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`36
`
`37
`
`38
`
`39
`
`Chothia. Cyrus. •oomain a ssocia tion in immunoglobulin molecules: The packing o f variable domains• J..._
`1:1'21. fliQl. 186:651-663 (1985)
`
`Clark et al ., •The improved lytic f unction and in vivo efficacy of monovalent monoclonal CD]
`antibodies • E~~gg~~ D Jg~~D~ l gf I mmungl Qs::t 19:381-388 (1989)
`
`Co et. al., "Humanized a ntibodies for a ntiviral therapy• e i::s:u;;, l:ill.tl
`
`a s:oag
`
`:ii;;i. !.!5A 88:2869-2873 (19911
`
`Coussens et. al . , •Tyrosine Kinas'e Receptor with Extensive Homology to EGF Receptor shares Chromosomal
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`
`Daugherty. BL et al ., 'Pol ymeras1e cna1n react1on fac1l1tates the cloning, CDR·gra f ting. and rapid
`expression of a murine monoclonal antibody directed against the CDl8 C0111Ponent of leukocyte integrins ·
`.,,.~,.,.;,.. 1'~;~~ n • • • • _,..., 19 (9) :247.l 2476 (May 11 19911
`-
`Davies. D. R. et al. .
`·Ant ibody-,!Ultigen Complexes • Ano Be:11:. Bi gi;;bem. 59: 439-473 (1990)
`
`-
`
`Epp et al., "The molecular structure of a dimer composed of the variable portions of the Bence- Jones
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`
`fendly et al., "Characteri2ation of murine monoclonal antibodies reactive to either the hwnan epidermal
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`
`Furey et al., · structure of a novel Bence- Jones protein (Rhel fragment at 1.6 A resolution• J:
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`l:lgl
`
`Gorman. so et al., "Reshaping a 1Lllerapeutic CD4 antibody• f ;cgs;; Ha t l As;;ag Si: i USA 88(10) : 4181- 4185
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`'The solution co11Jonnations of the subcl asse s o f human lgG dedu ced from sedimentation
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`
`Hale et al .• "Remission induction in non -hodgkin l ymphoma with reshaped human monoclonal ant ibody
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`
`Harris and Emery. •Therapeutic aJ~tibodies -
`
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`
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`
`Hud2iaJt et al ., •pl85IWU Monoclonal Antibody Has Antiproliferat ive Effects In Vitro and
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`Jaffers . G. J. e t al .• "Monoclonal antibody therapy. Anti·idiotypic and non -anti-idiotypic antibodies
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`Jones , P. T. et al . , • Repla cing t:he complementarity-determining regions in a human antibody with those
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`
`Junghans et al .• "Anti-Tac- H, a h~ized antibody to the interleukin 2 recep tor with new features for
`immunotherapy in malignant and i~rimune d isorders • caoi:ei:: Besea:ccb 50151 : 1495-1502 (Ma r 1, 1990)
`
`Examiner a . ' r}--Arr'L_
`
`p,!1;
`
`Kabat et al . s1un.ums;;es gf e i::2 teius gf Imml.Ula l Qgis;;al Ioteust . Bethesda . MD: Nationa l Institu tes of
`40 Health pps . iii-xxvii, 41 - 176 (1!187 )
`
`I Date Considere0
`1~1,/96
`·~C.
`'Examiner: Initial if reference considered, whether or not citation is in ronfonnance with M~; draw line through c~ation
`if not in confonnance and not considered. Include COP)' of this form with "1~ communica ·
`t applicant.
`.
`/> ./'.,
`<\)fl~L;V
`
`US COMM·DC 60·398.
`
`354 of 1033
`
`BI Exhibit 1002
`
`

`

`-
`., FORM PT0-1449
`
`'.l7
`
`- ·~
`
`-~ ,
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`'u.S. Dept. of Commerce
`.l. '
`~ 1995
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`LIST OF DISCLOSURES CITED 1.1 , ,,,.,'LICANT
`
`Patent and Trademark Office
`
`(Use several sheets if necessary)
`
`•
`
`Atty Docket No.
`P0709Pl
`Applicant
`Carter and Presta
`Filing Date
`17 Nov 19'93
`
`Sheet l..._ of
`
`4
`
`- -
`
`Serial No.
`l
`08/146 , 206
`
`Group
`1806
`
`'~
`
`qi
`
`OTHER DISCLOSURES (Including Author, Title, Date, Pertinent Pages, etc.)
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`
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`
`~ ~ -4·3
`
`Love et al, "Recombinant antibodies possessing novel effector functions" MetbQQ~ in 1::n~m2l2ro:: 178:515-
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`' Direct interaction of a ligand for the erbB2 oncogene product with the EGF receptor and
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`·- ·-.-.-- 44' p185erbll2• Ss::ience 249:1552-1555 (1990}
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`
`6:535-554 (19881
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`-- - . 45
`··- .46
`-·-- -47- Kol and i ts antigen-binding fragment at 3.0 A and 1 . 0 A resolution• J.
`
`Margolies et al., "Diversity of light chain variable region sequences among rabbit antibodies elicited
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`Marquart et al., "Crystallographi..c refinement and atomic model s of the intact immunoglobulin molecule
`.MQl' IliQl, 141(4) : 369-391 (Aug
`
`25, 1980)
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`IHQl
`
`- - -- •48
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`
`Morrison, s . L. <>t al... "Chima:ric hwnan antibody 11\o lecul.:.s, mouse antigen-bindincr domains with human
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`
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`.
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`---- ~s1.- -(December 1984)
`
`1985}
`Pluckthun, Andreas, "Antibody engineering: advances frol!I the use of escherichia coli expression
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`!>!>
`
`56
`
`- · _
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`Neuberger , M. s . e t al . , "A hapten-specific chirnaeric IgE antibody with human physiological effector
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`Sci. USA 86:10029-10033 {19891 ~V -
`·--··-.. - }~ - .
`,_.
`
`·- _ ,
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`-
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`Saul et al. , "Preliminary refinement and structural analysis of the Fab fragment from hwuan
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`lo ..... • +-t-
`
`5?
`
`-= f"• "59.
`
`I_
`
`Seg<il et <il.,
`'The three -dimensional structure of a phosphorylcholine- binding mouse imrnunoglobulin Fab
`60 ' and the nature o f the an tigen binding site" !:';:~~
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`tlsi.tl As::.:i.!J Ss;;i
`
`I Date Considered
`I /J ;z.>'. q;,.
`Initial if reference considered, whether or not citation is in conformance with MPEP 609; draw line' through citation
`'Examiner:
`if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`'}) (J-'()l '-~
`
`Examiner
`
`fbu1n1!/
`
`M
`'
`
`I
`
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`
`to/<.9 r/ot
`
`fl
`
`(./
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`I SCOMM·DC 80-398.
`
`. ~A ,.-
`
`355 of 1033
`
`BI Exhibit 1002
`
`

`

`, -
`
`FORM PT0· 1449
`
`U.S. Dept. of Commerce
`,,
`Patent and Trademari< Office
`
`LIST OF DISCLOSURES CITED BY APPLICANT
`(Use several sheets tt necessary)
`
`.. Sheet 4
`
`of
`
`4 -
`
`,I
`
`S~ria.l No.,
`l.~ l J 'L ·~ d t
`OBY.:1"46';206'1
`
`I
`
`1
`
`' /'~
`IJLu ~'. (J °\'~'15
`
`Alty Docket No.
`P0709Pl
`Applicant
`Carter and Presta
`Filing Date
`17 NOV 1993
`
`cl'·r= 1Kii/ . ;'- ',; I.
`PN Sha.Lal:>y et a.L .. "Development of hwnaruzed bispecific antibodies reactive with cytotoxic lymphocytes ana
`
`OTHER DISCLOSURES (Including Author, Title, Date, Pertinent Pages, etc.)
`
`)
`
`61
`
`62
`
`63
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`64
`
`65
`
`66
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`67
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`68
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`69
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`70
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`71
`
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`
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`
`Sherman et al., "Hal operidol binding to monoclonal antibodies• .ia1.101al Qf BiQl i;igii;;al Chemistry 263:4064-
`4074 (1988)
`
`Silverton et al. I "Three-dimensional struct-ure of an intact human il!Ullunoglobulin • fZ::Qs;:
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`Si;;i
`
`l::lat.l
`
`acad
`
`Slamon et al. • "Hwnan Breast Cancer; Correlation of Relaps e and Survival 111ith Amplification of the HER-
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`
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`.and Gf:cetics, Alan
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`Sox et al., "Attachment of carbohydrate to the variable region of myeloma i!11111unoglubUlin light chains•
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`
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`
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`72 Constant Region• J.
`llllllll.ID'2l
`
`·1•rameworit resiciue IJ. is a maJor Cleterminant ot tne position ana conrormatcion or tcne
`1Tramoncano et aJ.. ,
`second hypervariable region in the VH domains of immunoglobulins• J.-MQl-Bi Ql 215(1) : 175-182 (Sep 5,
`1990)
`Verhoeyen, IL et al.. •Reshaping human antibodies: grafting an antilysozyme activity• science
`239(4847) : 1534-1536 (Mar 25 , 1988)
`
`Waldmann, T . , ".Monoclonal antibodies in d1a.qnos1s and therapy• Ss;:;u::ns;:e 252:1657-1662 ( 19911
`
`Wallick et al., "Glycosylation of a Vii residue of a monocl onal antibody against alpha fl--·-6) dextran
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`
`Winter and Milstein, "Man-made antibodies• ~ 349(6307) :293-299 (Jan 24 , 1991)
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`Yamamoto et al ., • similarity of protein encoded by the human c-e.rb-B-2 qen.e to epidermal growth factor
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`
`73
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`74
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`75
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`76
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`77
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`j
`. tY
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`p/\/ 78
`
`Examiner lj i
`
`.__,_,. ,~
`
`/ML-
`
`I Date~~de~i
`/Z~l//9'6
`J YVJJ
`'Examiner: Initial tt referenct considered, whether or not citation is in conformance with MPEP 609; dr~R6-through citation
`ff not in conformance and not considered. Include copy of this form with next comm~cation ~· amiJica t.
`I -
`-
`cl"\A rp--
`
`USCOMM-OC 80-398.
`
`356 of 1033
`
`BI Exhibit 1002
`
`

`

`PATENT DOCKET 709P1~
`
`Paul J . Carter et al.
`
`Serial No. 08/146,206
`
`Filed: 17 November 1 993
`
`For:
`
`METHOD FOR MAKING HUMANIZED
`ANTIBODIES
`
`REQUEST FOR A CORRECTED FllLING RECEIPT
`
`Honorable Commissioner of Patents
`and Trademarks
`Washington. D.C. 20231
`
`Sir:
`
`Attached is a copy of the Official Filing Receipt received from the PTO in the above application
`
`for which issuance of a corrected filing receipt is respectfully requested . Please make the correction
`
`as follows: Under ''CONTINUING DATA AS CLAIMED BY APPLICANT-" , please delete "07/ 715,222
`
`06/14/91 PAT D 335, 559" and insert --07/715,272 06/ 14/91 ABO--.
`
`The correction is not due to any error by applicant and no fee is believed to be due. However,
`
`in the event that the Patent Office determines that fees are due in connection w ith the filing of this
`
`document, we hereby authorize the Commissioner to charge such fees to our Deposit Account No. 07-
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`0630.
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`A copy of a document pursuant to 37 C.F.R. § 10.9(b} is attached as proof of the aut horization
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`of the undersigned to prosecute the above-mentioned applica1tion. The original of this document is on
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`t
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`. Date: