Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Filing
567
DECLARATION of Linda A. Sasaki-Baxley in Support of Amgen Inc.'s Opposition to Roche's Motion for Summary Judgment That Claim 1 of the '422 Patent is Invalid Under 35 U.S.C. Sec. 112 by Amgen Inc.. (Attachments: #1 Exhibit Ex. A#2 Exhibit Ex. B#3 Exhibit Ex. C)(Rich, Patricia)
Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Case 1:05-cv-12237-WGY
Document 567-4
Filed 06/29/2007
Page 1 of 10
Dockets.Justia.com
211 .S CSU 53 rednU dilavnI si tnetaP 224' fO 1 mialC
taht tnemgduJ yrammuS rof noitoM s'ehcoR oT noitisoppO s'negmA fo troppuS ni .lceD yelxaB
C TIBIHXE
Doc. 567 Att. 3
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YGW-,·180 I-79 EVA tibihxE lairT
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STTESUHCASSAM FO TCIRTSID TRUOC TCIRTSID SETATS DETINU
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ecneuqes AND eht fo noisserpxe tnanibmocer eht sA .tnetap eht fo 6 erugiF ni htrof tes yb niteioporhtyre namuh gnicudorp fo sdohtem sebircsed tnetap 080' eht fo 01 elpmaxE ma .)"tnetap 080" eht"( 080,126,5 .oN tnetaP setatS detinU fo tnetnoc eht htiw railimaf
.snoitacilppa
yrotaluger
fo
esnecil eht fo
noitaraperp
dna ,tnempoleved ssecorp
gnirutcafunam ,hcraeser lacinilc
,hcraeser yrotarobal gnidulcni stcudorp niteioporhtyre s'negmA fo tnempoleved stcepsa lla ni devlovni saw I ,elor taht nI .7991 fo yluJ litnu yticapac taht ni deunitnoc redael eht emaceb I dna negmA ta maet tnempoleved tcudorp niteioporhtyre eht rof noisserpxe ,4891 rebmevoN nI .sllec nailammam morf niteioporhtyre fo noitcudorp dna
eht rof
elbisnopser
saw
I
,yllacificepS .ygolonhcet
AND tnanibmocer fo
esu
hguorht
fo
negmA ta niteioporhtyre namuh fo noitcudorp dna tnempoleved eht htiw devlovni .tnempoleveD tcudorP neeb dah dna no dekrow I ,7991 yluJ hguorht 3891 morF lleC raluceloM fo daeH fo rotceriD dna ,tnempoleveD tcudorP fo reganaM ,ygoloiB yrotarobaL sa emit emos rof gnivres retfa tnempoleveD tcudorP fo rotceriD roineS yraunaJ
noitisop
eht dleh I
,emit taht
tA .8991
ylsuounitnoc
-oc
saw
dna tsitneicS hcraeseR
a sa
ni deriter I litnu negmA yb deyolpme 1891 ,21 rebotcO no negmA denioj I
ot
.niteioporhtyre
tnanibmocer
etaler hcihw fo ynam ,derohtua
ygoloiB raluceloM
a sedulcni hcihw eativ mulucirruc ro derohtua evah I taht snoitacilbup eht fo tsil saw ym si 1-BKJ RbihxE dekram dna otereh dexennA .2891 ylrae ni dedrawa ym detelpmoc .D.hP ym dna 1891 rebotcO ni krow siseht
ni
eerged
ygoloiB raluceloM ta I .5791 ni selegnA soL ,ainrofilaC fo ytisrevinU eht etutitsnI AND gnitalosi eht ta margorp .D.hP eht deretne I ,gnippam noitcirtser dna ANR dna
sa a
ni
ogeiD
yrotarobaL hcus krow ygoloib ralucelom lareneg fo sepyt suoirav gniod naicinhcet eht sa etutitsnI klaS eht ta raey a gnikrow retfA .4791 ni aciremA fo setatS detinU ym deviecer I ainrofilaC fo ytisrevinU eht morf ygoloiB ni eerged .A.B
naS ta
:tcerroc dna eurt eb ot deveileb
era
feileb
ro
noitamrofni
no
edam stnemetats
taht aciremA
lla taht dna ,tcerroc dna
eurt era
fo-setatS detinU eht fo swal eht rednu
,egdelwonk nwo ym fo niereh edam stnemetats lla yrujrep fo ytlanep rednu eralced ,enworB
.K
yerffeJ ,l
.D.hP ENWORB .K YERFFEJ FO NOITARALCED
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100.$U.Iccdrmh enworb
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.ainrofilaC ,ytnuoC arutneV ni 9991 ,82
rebmetpeS
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.tnetap 080' eht fo 6 erugiF ni 561 ot 1+ sa htrof tes ecneuqes dica onima editpepylop eht si tcudorp niteioporhtyre siht fo ecneuqes dica onima ehT .enobkcab ecneuqes dica onima 561 a htiw nietorpocylg a si tcudorp niteioporhtyre sihT .elpmaxE taht ni debircsed dna detaerc sllec fo noitalupop lanigiro eht morf detceles ,neeb ot enil llec OHC a gnisu ,tnetap 080' eht fo 01 elpmaxE gnidrocca decudorp sah syawla dna ,si ediw-dlrow seesnecil sti dna negmA yb dlos dna edam niteioporhtyre negmA ta niteioporhtyre ehT .5891 ni noitcudorp elacs egral sti nageb negmA ecnis noitcudorp eht htiw railimaf osla ma I ,redael maet niteioporhtyre remrof
namuh fo
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tnempoleveD
tcudorP lacituecamrahP :tnatlusnoC
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.cnI
negmA ,tnempoleveD tcudorP ,rotceriD roineS
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negmA ;ygoloiB lleC raluceloM ,daeH tnemtrapeD
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7791-5791 ,tnarG gniniarT ygoloiB raluceloM .H.I.N 0891 7791 ,tnarG gniniarT sciteneG .H.I.N
:spihsralohcS
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ainrofilaC fo
ytisrevinU ,ygoloiB
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yb ydutS
ta
".slaminA gniviL otni refsnarT eneG detacideM-AND riehT dna seneG nailammaM denolC fo secneuqeS" ,eltiT sisehT .D.hP
.ainrofilaC ,selegnA soL ,selegnA soL ainrofilaC fo ytisrevinU ,etutitsnI ygoloiB raluceloM ,ygoloiB raluceloM1891 .D.hP
:noitacudE
:pihsnezitiC
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setatS detinU nerdlihc eerht ,deirraM 2591 ,92 yraunaJ ainrofilaC ,selegnA soL
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0238-484 )508( 01039 AC ,olliramaC aroruA ellaC 4421
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EATIV MULUCIRRUC
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eht fo
noisserpxE
xoF
dna
,F nitraM ,MG
dna
.4857-0857 ,28 .ASU .icS .dacA ltaN .corP .eneG niteioporhtyrE namuH gninolC .)5891( E ressawdloG dna HP iaL ,MS iwardaB ,Z yksnibatS ,KK trehC ,CJ eifgE ,R gnillamS ,KJ enworB ,H-C niL ,S sgguS ,K-F niL
fo noitaziretcarahC
yeknoM tnanibmoceR
.053-933,191 .seR .loiB dna .nilC .gorP .OPE namuH .)589 !( K-F niL dna P iaL ,KJ enworB ,CJ eirgE
591pg
.28 -36 ,581 .loiB .deM .pxE .vdA .tnanibmoceR suriV eniccaV-EGT a yb dna iloc.E ni desserpxE nietorP ekipS VEGT fo seidutS .)5891( KJ enworB dna R gnillamS ,J ikswezsurB ,S uH
.kroY weN ,robraH gnirpS dloC .052-542 ,)A.R remeL dna MR kconahC .de( .Y.N ,robraH gnirpS dloC ,muisopmyS ;yticinegonumml dna ecneluriV suriV fo sisaB lacimehC dna raluceloM :seniccaV ot sehcaorppA medoM nI .seniccaV tnanibmoceR fo noitcudorP .)4891( AG rettiB dna D notneF ,KJ enworB ,B lamaS ,NW ettemuB
B-sititapeH
desrepsretnI
selepiL ,M
eneG .emoneG eht ni erehweslE namuH .)189 I( W reslaS dna J
.681-771 ,51 dnuoF era secneuqeS ecapS eneG ANR lamosobiR touH ,OM nitraM ,KJ enworB ,DH gnatS ,R ihcugiH
eneG
.Y.N kroY weN .cnI ,ssiL .R nalA .433-313 ,)siuhneiN .A dna soluoponnayotamatS .G .de( II .loV ,seneG nibolG fo noisserpxE dna noitazinagrO nI .eciM gniviL fo slleC worram-enoB otni seneG nibolG namuH tresnI ot slaminA tcatnI ni snoitceleS ecnatsiseR gurD fo esU :seuqinhcet ypareht .)1891( JM enilC dna M ilE-raB ,K alocreM ,KJ enworB ,DH gnatS ,DB gnoT ,W reslaS
fo eneG weN eneG
a
.5301-3301 ,802 ecneicS .eciM fo slleC vxorraM enoB otni fo noitresnI .)0891( JM enilC dna W reslaS ,KJ enworB ,DH gnatS
W reslaS dna J enworB
nigirO lariV ,CK alocreM
.)0891(
.524-224 ,482 erutaN .slaminA tcatnI ni refsnarT ,R thcerpuR ,L esroM ,.K alocreM ,H gnatS ,JM enilC
.6481-2481 ,77 .A.S.U ecneicS .dacA ,ltaN .corP .emoneG suriV sititapeH kcuhcdooW dna B sititapeH namuH eht morf devireD sAND tnanibmoceR fo nosirapmoC dna noitaziretcarahC ,noitalosI .)0891( J sremmuS dna MJ celomS ,LR redynS ,VG relyT ,AW reslaS ,KJ enworB ,WI sgnimmuC .193-983
,591 ecneicS .sdimsalP iloe aihcirehcsE
editoelcuN
.)7791(
otni detresnI eneG nibolG ateB tibbaR morf secneuqeS W reslaS dna CH llednieH ,P ekralC ,A uiL ,VG kcoddaP ,KJ enworB
.402-771,91 .seR sdicA .leuN .gorP .sdimsalP lairetcaB otni noitalosI rieht dna secneuqeS ANRm nibolG fo noitanimreteD .)6791( P rakaZ dna G akcindutS ,J streboR ,G kcoddaP ,R ihcugiH ,H llednieH ,P ekralC ,KJ enworB ,W reslaS
:SNOITACILBUP
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.963-563 SG ssoM dna LH
a
,401 yregruS .noitanoD doolB suogolotuA dna niteioporhtyrE namuH tnanibmoceR .)8891( lagheS ,KJ enworB ,CJ eirgE ,RL lagheS ,AS dluoG ,LA nesoR ,AE eniveL
:92
.29-881 ,38# .ttiM .tsnI gnirheB .troper ssergorp :esaesid laner egats-dne fo aimena eht tcerroc ot )OPE( niteioporhtyrE namuH tnanibmoceR fo esU ehT .)8891( W hcabhcsE dna RM gninwoD ,KJ enworB ,CJ eirgE ,W nosmadA .652-142 pp .yrotarobaL robraH gnirpS dloC .seigolonhceT weN eht gnissessA :snietorP dna seditpeP citueparehT tropeR yrubnaB .niteioporhtyrE namuH tnanibmoceR dna larutaN fo seidutS evitarapmoC .)8891( WT dnalkcirtS dna ,.T ,awakarA ,.F ,niL ,P iaL ,KJ enworB ,CJ eirgE ,.D ,kenpaV
.sserP namuH fo
ytisrevinU
drofxO ,ygolonircodnE raluceloM ni scipoT detceleS nI .seneG niteioporhtyrE yeknoM dna noisserpxE dna gninolC .)7891( S sgguS dna CJ eirgE ,KJ enworB ,HP iaL ,K-F niL
a fo stluseR eht fo noitcerroC
:niteioporhtyrE namuH .)6891( WJ nosmadA
.87-37 ,613 enicideM fo lanruoJ dnalgnE weN .lairt lacinilc II-I esahP tnanibmoceR htiw esaesiD laneR egats-dnE fo aimenA dna KJ enworB ,RM gninwoD ,CJ eirgE ,WJ heabhcsE
yendiK .)DRSE(
tnanibmoceR dloC
N
.)6891(
esaesiD laneR egats-dnE ni tceffE WJ nosmadA dna KJ enworB ,RM
.tnemelppuS lanoitanretnI :)OPEuHr( niteioporhtyrE namuH gninwoD ,CJ eirgE ,WJ hcabhcsE
.seitreporP lacigoloiB
E nostaW
gnibbetS dna
.207-396,15 ygoloiB evitatitnauQ no aisopmyS robraH gnirpS dna ,erutcurtS nietorP ,gninolC eneG :niteioporhtyrE .)6891( ,T dnalkcirtS ,K-F niL ,HP iaL ,CJ eirgE ,MA nehoC ,KJ enworB
,KJ enworB ,K-F niL ,G liarT ,R gnillamS ,MA nehoC ,K ikoA ,J
namuH tnanibmoceR fo stceffE
lacigoloiB
.422-312 ,271 ,ygoloibonummI .niteioporhtyrE dna noitaziretcarahC .)6891( KD seniH dna enaL ,WT dnalkcirtS ,CJ eirgE
.902-102 ,44 ,eneG .eneG niteioporhtyrE namuH eht htiw nosirapmoC dna noisserpxE ,gninolC :eneg niteioporhtyre yeknoM .)6891( S sgguS dna M ortsaC ,KK nehC ,MG xoF ,R gnillamS ,CJ eirgE ,KJ enworB ,HP iaL ,H-C niL ,K-F niL
.021-311
,95 .dnatS .loiB .veD .negitnA
ecafruS B
evitaleR dna
sititapeH devired-AND tnanibmoceR fo snoitaraperP suoiraV fo ytieinegonummI seitreporP .)5891( AG rettiB dna KJ enworB ,B lamaS ,NW ettenruB
.3827-0827 ,28 .ASU .icS .dacA ltaN .corP .slleC yravO retsmaH esenihC ni enomroH gnizinietuL enivoB evitcA yllacigoloiB fo noisserpxE .)5891( .H.J ,nosliN dna RA nosamohT ,MT tteN ,F drofsidnoW ,KJ enworB ,MD lezteaK
dna .nilC no .gorP .niteioporhtyrE yeknoM dna ynoloC etycoyrakageM .)5891( K-F niL dna KJ
.911-501 ,512 .seR .loiB namuH tnanibmoceR fo ytivitcA gnitalumitS enworB ,WT ,dnalkcirtS ,CJ eirgE ,PP sekuD
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.328-318:21 ,lanruoJ
ot aresitna fo
.utis ni noitzazilausiv sti dna V esarefsnartlynimasoculglyteca-N elbulos ,tnanibmocer noitaraperP .)5991( M ecreiP ,N negierF ,J enworB ,B reldA ,N gnahZ ,L nehC
etagujnococylG
.58351-18351 ,862 ,.mehC .loiB fo .J .V-esarefsnartlynimasoculglytecA-N gnidocnE ANDe a fo noisserpxE dna ,noitaziretcarahC ,noitalosI .)3991( M ecreiP ,N neigerF ,P stlahkcuB ,R selppuC ,R usaB ,J nietsnieW ,B reldA ,SG gmeP ,M habierohS
,KJ enworB ,ZD
neW
.lesaB
,regraK
tcudorP
.511-501 .pp ,67 .loV .noitazidradnatS
lacigoloiB
fo
tnempoleveD .ycnetsisnoC
no noitatnemreF fo stceffE .)1991( J enworB ,ebeiW ,R kcinraG ,S redliuB ,R noohtarA ,D eiksdbaZ ,G namressaW ,B atikO ,M akO ,J neilatI'L ,J yawallaC ,K alumunA ,SA ikceinibuL
.dnalreztiwS ,regraK ,lesaB .08-27:88 ,)L kerozeieW ,P allagicS ,W nebeltmaS ,J naroM ,J H dnaduG .de( ygolorhpeN ot snoitubirtnoC .saimenA laneR-noN dna laneR ni niteioporhtyrE :nI .setatS detinU eht ni slairT lacinilC fo stluseR :ahplA-niteopE .)1991( WI. ,nosmadA ,KJ enworB ,RM gninwoD ,CJ eirgE ,WJ hcabhesE
fo
ytefaS
ehT
snikpoH
nhoJ ehT
,)slraeniW
GC dna hcabhcsE
WJ
.nodnoL dna eromitlaB ,sserP .vinU WJ
,nosmadA
:nI
:niteioporhtyrE
:otnoroT
N
,niteioporhtyrE
,velsrE DA .sde( 04-12 .pp ,ygoloiB lacinilC dna ralulleC ,raluceloM fo ygoloiB raluceloM ehT .)1991( KJ ,enworB ,CJ ,eifgE
.21-1 ,secivreS noitacudE lacideM SEM dna erutcurtS nietorP ,gninolC eneG :niteioporhtyrE nI .)0991( dnalkcirtS ,K-F gniL ,HP iaL ,CJ eirgE ,MA nehoC ,KJ enworB
.seitreporP lacigoloiB gnibbetS ,E nostaW ,T
.038-528 ,362 .A.M.AL .niteioporhtyrE namuH tnanibmoceR htiw detaerT stneitaP sisylaidomeH fo efiL fo ytilauQ ehT .)0990 )WJ nosmadA dna K namrekcuZ ,BD kcyW naV ,CJ enotS naV ,P nahcseT ,J W enotS ,J namdvitS ,AE ,ykstuR ,PE ininagaP ,AD nedgO ,RA nosnessiN,PA nidnuL ,KS ztnarK ,MS tebroK ,RN yelaH ,AE nami·eirF ,W deirF ,CJ eirgE ,RM gninwoD ,GB onaleD ,KJ enworB ,WJ hcabhcsE( .puorG lairT lacinilC OPE retnecitluM evitarepooC eht dna LD neinnaM ,L enaiD ,B redaR ,WR snavE lacinilC retnecitluM III esahP
a
.0001-299,1 .enicideM lanretnI fo slannA .lairT fo stluseR :esaesiD laneR egatS- dnE htiw stneitaP cimenA
ni niteioporhtyrE namuH tnanibmoceR .)9890 WJ nosmadA dna K namrekcuZ ,BD kcyW naV ,CJ enotS naV ,P nahcseT ,JW enotS ,J namlevitS ,AE ykstuR ,B redaR ,PE ininagaP ,AD nedgO ,RA nosnessiN ,PA nidnuL ,BS ztnarK ,S tebroK ,RN yelaH ,ES rcbarG ,AE namdeirF ,WR snavE ,CJ edgE ,RM gninwoD ,GB onadD ,KJ enworB ,HM idahludbA ,WJ hcabhcsE .22671-91671 ,462 .mehC .loiB .J .editpeP langiS a htiw rohcnA langiS lanimreT-2HN eht fo tnemecalpeR yb nietorP yroterceS a ot esarcfsnartlylaiS sutarappA igloG a fo noisrevnoC .)9891( CJ nosluaP dna KJ enworB ,B reldA ,UE eeL ,J K yelloC
561-061 ,67 .lorhpeN .rtnoC .stneitaP sisylaidomeH ni stluseR :)negmA( niteioporhtyrE namuH tnanibmoceR htiw lairT lacinilC retnecitluM ASU .)9891( WJ nosmadA dna KJ enworB ,CJ edgE ,RM gninwoD ,/VI. hcabhcsE
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eht fo noitcerroC lanoitanretnI ht5
niteioporhtyrE namuH tnanibmoceR htiw )DRSE( esaesiD laneR egats-dnE fo aimenA .)6891( WJ heabhcsE dna KJ enworB ,RM gninwoD ,CJ eirgE ,WJ nosmadA
.6891 ,02-71 .tpeS ,aimerU no ecnerefnoC irpaC esaesiD laneR egats-dnE ni tceffE :)OPEuHr( niteioporhtyrE namuH WJ nosmadA dna RM gninwoD ,KJ enworB ,CJ eirgE ,WJ hcabhcsE .361 ,301 .loiB lleC .J .slleC OHC detcefsnarT ylbatS ni enomroH fo noitcudorP setalumitS eneG tinubuS-ahplA eht fo noitacifilpmA HJ nosliN dna RA nosamohT ,KJ enworB ,MT tteN ,MD dzteaK
.)DRSE( .tnanibmoceR .)6891(
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.854,31 .lotameH .pxE .niteioporhtyrE tnanibmoceR namuH eruP fo noitaziretcarahC .)5891( ,KJ enworB ,G liarT ,R gnillamS ,K ikoA ,J enaL ,T dnalkciftS ,CJ eirgE
.notsoB ,ygoloisyhP lleC metS no muisopmyS lairomeM namlhotS keifderF launnA ht0 .niteioporhtyrE yeknoM dna namuH tnanibmoceR fo noitaziretcarahC .)4891( PP sekuD dna C yeldarB ,R gnillamS ,KJ enworB ,K-F niL ,J enaL ,J eirgE .753
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:STCARTSBA
dna
.sserp nI .ygolorhpeN .coS .remA .J .stneitaP sisylaiD ni )OPEuHr( afla niteopE )PSEN( nietorP gnitalumitS siseioporhtyrE levoN fo scitenikocamrahP eht fo nosirapmoC .)9991( J ,eirgE ,J ,enworB ,B ,snikneJ ,C ,neerB ,O ,yovEeM ,J S ,yarG ,CI ,llaguodcaM .sserp nI .enicideM yranireteV fo J .sgoD lamroN ni niteioporhtyrE ytieinegitnA .)7991( CJ eirgE ,A relliM ,KJ enworB ,AL laeN ,DL ,lligwoC
no
tnanibmoceR fo
,J S ,bawhcS ,MD ,otomakO ,RA ,nosnessiN ,CJ ,eirgE ,KJ ,enworB ,KW ,notloB ,A ,baraseB
dna 825-125 ,212 .cossA enicideM yranireteV .remA .J .eruliaF laneR htiw staC sgoD ni aimenA fo tnemeganaM rof niteioporhtyrE namuH tnanibmoceR fo esU .)899 I( ,CJ ,eifgE dna ,TR ,reigniboL ,A ,relliM ,BJ ,enworB ,KJ ,yveL ,MK ,semaJ ,DL ,lligwoC
sisylaidomeH
.095-485 ,933 .deM .J .lgnE .N .esaesiD caidraC htiw stneitaP tircotameH cimenA susreV lamroN fo stceffE ehT .)8991( AD ,nikdooG
Case 1:05-cv-12237-WGY
Document 567-4
Filed 06/29/2007
Page 9 of 10
62847900
CTI-MA
951091076MA
.AC ,ocsicnarF naS ,4991 enuJ ,muroF enicideM yranireteV launnA ht21 .enicideM lanretnI yraniretev fo egelloC naciremA .sgoD lamroN ni )OPEuH-r( niteioporhtyre namuH tnanibmoceR fo yticinegitnA .)4991( A ,relliM ,J ,enworB ,J ,eirgE ,L ,laeN ,DL ,lligwoC
.ecitcarP
latipsoH
.J
.slacigoloibfo
lacinilc dna ygolonhcetoiB .)3991( D
,notneF
esu lacinilC :owt trap enicidem dna ,J ,enworB ,AC ,olleraniD ,PR ,snevE
eht fo noitcerroC
naS
niteioporhtyrE namuH tnanibmoceR htiw )DRSE( esaesiD laneR egats-dnE fo aimenA .)6891( WJ nosmadA dna KJ enworB ,RM gninwoD ,CJ edgE ,WJ hcabhcsE
.doolB .AC ,ocsicnarF ,6891 .ceD ,ygolotameH .coS .remA .lairt lacinilc fI-I esahP a fo stluseR :)OPEuHr(
.891,13 lanoitanretnI yendiK .lairT lacinilC
II-I esahP
a
fo stluseR
:)OPEuHr(
Case 1:05-cv-12237-WGY
Document 567-4
Filed 06/29/2007
Page 10 of 10
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