Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 1006

MEMORANDUM in Support re #1005 MOTION in Limine to Preclude Amgen from Asserting that there Was a Restriction Requirement Separating the '008 Patent Claims From the Claims of the '868 and '698 Patents filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C#4 Exhibit D (Part 1 of 3)#5 Exhibit D (Part 2 of 3)#6 Exhibit D (Part 3 of 3)#7 Exhibit E)(Seluga, Kimberly)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

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Exhibii D, Pan 2

Restriction Group Claim Language
ocumng crythropoictm. Siiid proess compriiig: growmg, under suitable numcni condiiions, prokaryotic or eukaryoiic hes! cdb transformed or trasfC'clcr wilh a
DNA VC".:Of according 10 cJ:iim 62, wid isolating desired pol)ipcpiidc produci, of
thccxprc~siol1orDN/\ scqucnccsins¡¡idvCtIOL

ïG, A pwccss for the pmdiic!km ¡ifr: polypeptide having pan or all ofilic primM)'
$1f!i,~iur;\! cü¡i(onii;l(Ìor¡ ;¡rd one or fl(,n: üfthe bio¡ogic~l! ilctiviiìc5 o( nan.ir;illy-

~)(cl.miiig cryihrop¿¡iciin, said pmc.:" c(impri,ing: growing, imdef wÜ;ibk iwiricf\ (:()ndíiinns, probl),'oiic or cuk;,l)útic host çdb Ir;m,Ùirmcó 0r U;lilSkc!;;d ",Üh a
DNA VCC(Df ;lccMding w claim 63, ;;nd iiolaiing d.:sil'¡;d iw1ypcpliile pmdw:l: or
Ihcexpn;ssio1\ofDNA~equel\cc$ in

s"idvcc\Of.

71. Aprocc$$!ôrlhcproduciioI16f,lpolypcplii!chavìngpartor"ll"fih;;prim:iry

SlfUctun:lç"nrorll:iîolialidoneúrmorcür!hcbíc!G~ìc,ii:ictivilÌeSüfnaturallvoccurring eryhru¡xìctín, said process compri,ing: g~owing, under SllÌt;lhk ni;iricni conditions, prolwryoiìc or cubryoiìc hCl$1 cells tmnsfornied or lraiisJCdcd wiih a DNA VC:d0f nccording 10 claim 65, and i:;olating dc::;ired polypepiide produCl of
ilic expression of DNA sequences in said

vC:;:10r.

'-

.. pmc,-',,, for the proouction ora piilypcplidc h;i\'in~: part Dr ;~11 üi"ihc prini;iry stim:tma! con!\m1l.,liül\ ;\Id (ine or nlere ~¡fik biu!ogi,,¡il activities Ui"ll;IIUf;IIYiJa,,¡rin¡, Cl:-ihrù¡Xliclil\, ;;,:id plO';Ö, (¡;mprìsii\g: ;tr'ì'.iii~. wider 511Iíahk' lH¡¡i~nr

conditions, pr;"L:I)oti,; Of ,'IIj.;lJyoiiç iw,¡ cd!; ii:imfmmd () t:~'n5k:;lcd willi;~ DN:\ vcc(ú: :lçço(Jìrig to cbill 6 Î, and isolating I.bircd ro!yp..pÜde ptoi.hicts ur
ihc cxprei.ifin of DNA sl.'qm:iiç;;., ins;iid

vcctOf.

; i

-I
Aprok:iotiecrcukaryotichostcc-lIst::blytninsfmmc:dortrausfeetcd vcctori\ccurding to c!¡¡im wÍlhil

DNA

37,

!.~ '_'_"_'_'m__~"___'_'o'_'j

CwuplV: Cdls

,

42,

ve-neb:';le cdl:; which c:in oc plùp:igaicd Ùi \'j¡m ¡;niinuou,ly and which upon
growth in Ctilturc nrc ;:;¡p;ibk ofprodiicing in dic medium nÎ thcir t-wwii1 iil ¡:~ccS5

oflÜiJ lof~f)ilw)jl¡)i"lÎl\¡).r ¡(j':;c!i, in ,j$!\m)r';hdcicrmincdhy
r;,di,)imn1lino;i",:i:'

~3 \\'lIcbr,:\1. cdb accürding w cbim .:2 e,p;,b!c ol¡iuJliçing in ¡..~cc,;, iil 5VJ U crythmj\Gidl1 p"r 100;:c!ls in4Show$,
4... VCl1cbralc ;:elb ;\i.vmJing 10 claim 4:; c;'ip::bk of pruducing iii exc.;" of l,(JDO U

etYlÏilùpoîciinpcrIO"ccl15ín4Slio11rs,
45. Vertcbmie cell; according to claim;1:! which ~lrc mammalian or aviim cells,
46. Vcrtcb!iic cell, ¡¡ceording lo claim .~5 which arc COS-L cdl$ or C¡ 10 cells.

i..__'m'",~'._"...
! (¡f(ì(i¡¡V:
I P!i;'l'il\(.'c:.iic,i!

C)1li"K'~¡l¡lIn

55. r\ ph;mnacciiik;il c()l\jwsitî01\ comprising un cff(;çÜvc ;iiiwwlt o!'l r0!Yreplidi.~ ;~~,ç0rJin~ to cbiriis 1, 16, 19, ~¡) ,,1'.;; ilnd a ph;wn;icciiiiculiy a(.\:cp¡ubk dilucni, adjiiv;iiii or carrier.

56, ..\ l1ictli¡;dforpn)vidingcrJ'ihropoi.;linihcmpyl\ain;ml1alcornpri,ing

l_~_____~

adnili.!slCriil~_~l ¡:irce~'y( alll0(J1\( (!~pS'l.n;g:,!h£.1Sçor~2.£!9.ims..I--.l~J');.5(J_.j

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Restriction Group I Claim Laguage

,. i i i,.; !¡!
or41,
miifonnly v:iiyingsequcncc$ orba.¡:s, c:ichofs;;¡d

, ,hcm:iocriikvds. ¡
57, ¡\ method :iceördirig 10 clii¡m 56 wherein the ihempy comprises cnhaiicing ¡
i

~r0UP \':1: ;\s~~'~--II"~- An im~';:~ in Ihc';~cth0d for detection ora "sP;;C¡r¡c single sl~mkd _..-I
I ~ r..1ynuclcotidc of uriknnwii sequence În a hc-¡crogcncolJ, cellubr () \'iml smnpk i

I ¡li¡;lmHn:t muhipk sir\g!e'$tr.mded polynucleotides whcrein: ,
. (,11 a mì.xllire of labeled sii\gle-strmdcd polynucleoiide probes b prepMcJ having ¡
probes being pOlL

'liiìally !

spcdlìc:illy eúmplcmC¡liary to a sequence ofbaies which i, pUl3livdy unique 10 the !

pOlYI1(c!cotìdct¡,bcdetec!cd;

(b) thc,.impkislixcdlOasolidsubsiratc;
te) llicsubslriich:ivingthcs;mp!clixctlhcrciolstr::Mcdtidiniinisli funlicr bindingofpolynudcuiidestkrciocxccplbywiiyofhybridil.1licnlo polynuckotidcsinsaids:mp!c;
(d) lIie trtllltd siibstrai.: having the sample !Ìxci.iheritü is miflsitoriiy COn!:H.:ted wiih said mixture ofbbekd probes und~'l conditions r¡icí!íi:iiive ofhybridil..ti()il only between ioially compkmciii:iry polymic!cotidcs; and
k) the spedlìc pi:lyiiuc!cl)idc i, deleclC'd by ¡ni:mílCirÌf\g fe ¡he rn:~ciice oLI

hybridí/~Hi()il reiieiìnii b;.lwCC'1l ii :ind a !01;Ü!y cmnpkmcni:iry pro¡,y,: wilhin s:Ü¡J

m¡~lu¡c ,iflab;:kil prnll':s. as (.'\;jderic,.¡j by the: prckn;:c ('(it ¡',i.:iicr (k:hÜy Or
!;bc!edm:\h:rj~l()ritj¡e$:lbli:ilc,ii!hc lo.(ISÖlihc sp,;:i!ic pü!yntli:kotide in

comp-iisun 10 r: backgroiind densiiy ofkilidcd m:ilc¡i¡il resi;j¡ing from n()~l-spç;;jjk

bindil1g,)fi¡,bd(:dprob!.~lCthe~a¡bw¡¡e.
,:,id improvement comprising using in exc"ss or 32 mixed probes and !wrforll:in,;,;
of ont: or mort: üfilic fQllow¡ng~

(i) çmpJoying:t nylon-based paper as ~aid solid subSirate;
(2) IrC;ltlng wilhaproieaseìnSlep(c);
(3) cmployingindivíduaJ 1;'lIx:JedprobcconeCtlira¡ionsof;ipproxill;iiclyO.ü25

picemob;mid
(-I) cmpioyingas()f1cofiheh)'briJi/~i1i()nç(mú¡li()ns in Sl,;fl(d)

, ,

sirîng::ni i

i ,

tc:iipefJl(r6 :ippmaching (¡¡ with ,jGC ¡¡WilY frum the lowC$1 cal¡tilm;;d "Id of miy (If I.

t p i em ,~-""---,-"'-_..._-'~h-e-r-d-c-s,~p-lo)'.d._,---,-~_._-"-_.,-,_., _c , .

149. As the Examiners poimed out in this Offce Action, by ¡¡ Preliminary

Amendment filed April 24, J 986, Amgcils couiisclliud sdccied ihe DNA-related inventions
idclltiîkd ilS Group I! for continued cxnnÚiiaiìoii in Dr. Lin's '29: Jpplîca¡íün, Thus, the

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Examiners withdrew the non-elected claims directed 10 the other inventions of

Groups i and il-

VI from fiJI1her consideration in the '298 ¡lpplic¡ltion, When an Examiner withdmws claims

from furth:.r consideration. under USPTO practicc ~ind procedures. it means iliattliüse c!:inis are

not subject to examination in the pri:sent lIpplicaiion, Therefore, alter the Examiners withdrew
the non-elected claims ¡rom further examination in the '298 application, Amgen's counsel's
option for obtaining patents on Dr. Lin's other inventions claimed in Groups i and ILL-VI was to

file udditional applic¡itîons to have those claims examined scpanltely from the claims in the '298

upp!icaiioii (which. ¡is wil! lx' explained in more dewi! bdow, is i..'x;ictly what :\rngcn's cOlinsd
did).

ISO, Dr. tiil's '298 applicaiion u!iímmdy issucd on Odolier 27,1987 ¡¡s the
'008 patent. Dr. Lodish has explained ¡hat. "consistent with Amgcl1 's election 10 have ihe Group

II claims examined in ¡he '298 application, all of

the '008 patent claims fhll within the scope of

restriction Group 11." Lodish ~ 53 I,
B. DR. UN'S '3~9 CL\IMSARE NOT 11"v,\L1Ll FOR OBVIOUSNESS-TYl'e

DOliBU: PATE!"TING OVER DR, IAN'S '008 CLAIMS
1. Ex:imìniiiinn Jlsiory of

Dr. l..n's '3,¡9 Palent
Dr. Lin's '349 patent begins with U.S, P;uent

151. 1'\.1y Jb¡cussion of

Application No, 06/1 i 3, 179 ("the' J 79 applicmion"). Dr. Lin's '179 application was filed on
October 23, i 987, aller the reslriciion requirement thiit was entered diiring examinmion of Dr.

LlIÙ '298 application. The' !79 application wus filed under 37 CF.R. § L60, which ix~niii!ted
Al1gcn's counsel to fik ¡he'! 79 applicJtiolì by siibmiiiing a true copy of

the prior '298

application. incluùing:i copy oCthe ¡)3.tli or deduriii¡OI1 originally ¡¡Icd in Dr. I.iils '298

application, 1n keeping \vith ¡he ctllier restríciion requirement, Amgcrls COiiliSel emiedlcd all

claims that belonged to restriction Group li (which were being examined in Dr. Lin's '298

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applk-aiiol1), and selected original claim I --- whìch belonged to restriction Group i - fÒr

examination in Dr. Un's; 179 application.
152, On June 6,1995, Amgcn's counsel advanced the examination leading 10

the '349 pawnt by filing U,$. Patenl ApplicJtion No. 08/468,369 ("the: '369 application''l Like
the' 179 applic-ation, Dr, Lin's '369 application was filed under 37 C.F.R, § i ,60, which

permitted Amgeils counsel to íìe the '369 application by submitting a true copy otih.: prior
'i ï9 ¡ipplìcmion, includíng ¡l copy orthe oath or dcdaraiion orígiiwlly fikd in Dr. I.in':- , 179

applic;nion. i\ncL ;is i¡ lwd doiie when Jilíng Dr. l.in's' i 79 application, Amgcn's cO\lbeL
coii:;¡sti.nt with the Examiners' 1986 n:strktion reaiiircmeni, c:;incdcd all claims tbm belonged!O

restriction Group II and selected claims from the other, non-elected groups fÖr cxamiimtion in

Dr. Lin's '369 application, Specilìcally, Amgcils counsel selected original claims 42-44, and 46
.._.- which belonged to restriction Group IV --- for further cxmninutioii in Dr. Un's '369
applk;:ltionyi Dr. Un's. 1 ì9 ;ipplication provided continuity for Dr. Un's '369 application to

p(.rmii i!iL' '3ÖiJ applkMion 10 ¡,laini ihe benefii oethe fì!ing. date \ll Dr. I,in's '298 applicmion
under 35 i),S.c. ~ 120,

153. As oncn happens during the course olcxaminatioii or a patent applicarion,

on May 16, 1997, Amgcn's counsel chose io c-aneel the claims then pending in Dr. Un's '369
applicatíon and to lèP!;icc them wiih new chiims to advuncc the examination ofilic appl¡C¡ltion.

!u During i:xarnin,l1iün. Allgi:n püil1tcd out to the Ex¡¡rnincr thai claims 42-4:. and .'l) \i,cn: "siibst:iiitklily idcntÎlal" to cl;:iiis 42.46 in the '298 appliiinion tÌlat w(,n,' assigned to restriction Group iv, ;'drawn 10 cells." (S('(' '349 rile History, Tab S, 12/24/96 Sceünd Prcliminary Amendment (AM-ITC 00942(95)). Amgcn also poímed OLlt to ¡lie Examiner that claim 61 (the pri:dccc$sor or'349 claim 7), although not an orîg.inal '298 claim, was "directed to a method for using the novel vertebrate cell:; or claims 42-44 and 46 for die production of erythropoietin,"
which the '298 specification taught as the intended use of

(he cells claimed in the Group iv

claims, ¡d,

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These new claims. numbered M;- 72. \Vere u1iimately allowed by the Examiner on September 9,
1997, and they issued as claims 1~7 of

Dr. Lin's '349 patent on May 26,1998.

154. 1 may use the following table iii my testimony in right orDr. L.odish's
expert repO!1 to expkiln how ¡he claims in Of. Un's '349 paltin relate to the origimi! claims in

Dr. Un's '298 application that were assignc.d to restriction Group IV:

42. Vencbratc cells which can be propagated in! 1, VeJ1ebrate cells which can be propagated in

\.itrQ COmil1lOiis1y and which upon growth in 1 vitro nnd which arc capubk upon growth in
,

i

culture 3re c¡ipabk oî producing in the medium I culture ofpruducing erythropolciin in ihe

üfihcir grm'.th iii excess of ¡OO U of ¡medium ofiheir growth in excess: of 100 U of
erythropoietin per I (/' cells in 48 hoiirs ;-is I erythropoietin per 10" celis in ,¡8 hours Wi

¡ detcrmined by radioimmunoassay. I dC1Crriined by r:-idioimmuno;issay, said cells
i

-13. Vcrtebr.!c cells :iccording to claim 42
capable of producing iii excess of 5ÜO U

i~ -.
¡ ¡

¡ erythropoietin per! üt. cells in 48 hours.
í 44. Vertebnite cells nccordilH.! to claim 42
f capabh: ofprodudng.in excL'SS M 1,000 U
I erythropoietin per 1 O~ cells in 48 hours.

i 45. Vcrtcbmte cdls according to claini 42

iI íí ii .I erythropoietin.
i i

Ii comprising non-human DNA si:qucnc('s which

! conirol transcription of DNA encoding human

IiofpVcrtcbnitcin cxcess 0(500 to claim i cap:ibk I 2. roducing cells according U erythropoietin j

IperI0(,cellsin4Shours. ¡
13. Vcrtcbmtc cells aecording io cJ,lini i capable I

¡ which arc mammalian or ¡¡vian cells.
i

i of producing in excess of lOOO U I
! erythropoiciin per 106 ceOs in 48 hours. j

,

¡ 46. Vcrtebratc cells according to claim 45

) which arc. CO$-l cells or CHO cells.

14. Vertebrate cells which can be propagated ín

I vitro which comprise transcription col1rol DNA $cqiicnccs, other than hum~n

Ii--..í

! cryt iropoielm transcnpuon contra scqucncL's.

1 for proÓiiciioii ofhuilan eryihmpoiciin. ,!nd

! \'.hich upon growth in ctllwre are capable of
i prodw;ing in ih.: indiUlll of ih::il' gl'owih in
I execs,; of 100 U of cryihropoidin per i Or. cells

1___

¡ .in -"--._--"--~--as-"~----~-"--~"~'bv'' i ._- 48 hours ~- determined ._'
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,¡ i- i I ,i . i
I r.dioinimunoassay.

15. Vcncbratc cells according 10 claim 4 capable I ¡ ¡ of producilìi! in excess of 500 U crvthropoictin !

¡ per 1((' cdls in 4g hours,. .
!

16. Vertebrate cells according to claim 4 capable I

i ofproJucing in excess of 1000 U
I erythropoietin per 106 cells in 48 bours

171 A process lor producing erythropoietin

! comprising ¡he step of culturing. under suii¡iblc ,

1"","","._"",_"

I n\Jricnl conditions, vcl1cbniic cells according : to çlaim i, 2, 3. 4, 5 or 6. ,

2. Under 35 U,S.c. § 121, Dr. Liii's 'OOS P;i1Ctl Cl:iiiis Cannot Be Used ¡is à Rcfcn:ncc to Invalidate Dr. Lin's '3.f9 Patent Claims
i 55. In his report, Mr. Sofoclcous appears !O suggest that the sali: harbor

provisions 01'5 V.S.C. § 121 do not prevent use orDr. i.in's '008 patent claims for purposes of
doubh:-p;itellting against Dr. Un '$ '3.:9 p:ilent because ihe appHc;-itions giving rise 10 Dr. Un's

'3.:9 pi-i.nt did not ,"xpressly state thut ihe c!uims in ihose applications were being fied as a
result ofihe restriction requirement in Dr. Un's '298 application:

In addition, Applicant made no mcinion in the continuation '381 application thaI he was filing ihe claims which issued ;IS ihe '349 in response to the restriction requiremcnt in the '298
applic;:.ion, Jet alone that hc was filing each orthe claims as a result orthat restriction.

SofÒdeous ~ 456.

156. As an initial maller, Dr. Lin's '381 :ipplic:nion, which issiied as Dr. Un's
'698 p(lcnt, is irn:kv¡mt to determining whetlier ~ 12 i prolcc¡ion applie;o to the' 349 P¡¡!çIlL But

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even assuming thaI Mr. Soroeleotls in!Cnded 10 refer 10 Dr. Un's; 179 or '369 applications,
\vhidilcd to Dr. Un's '349 patent 1 disagree wiih :iiiy suggestion tha¡ an applícant must recile

the words "in response to the rcstrìction requiremellt" or "as a result of

the restriction

requirement," or any oiher such phrase, in order 10 gain the protections of § 121, ¡"k Sofocleous
does not cite any legal suppún lì.)r ihis proposiiioii. Nor am I aware of ¡my such legal

requirement. Rather, as explained above, the * 12 i rcquiremeni ihaltlie ¡ipp!íclltion be lilcd "as
a resii!t or a restiction requiremenl" is satisfied if the firsi appliçation giving rise to thC' pa!Cnt-

in-suit ti!cd :lih:r ilh. rcstridion n:quirement containd claims dr,iwii only to thc lion-(.kctcJ

invention or inventions (and nm to the invention ckçied in rC'sponse to ¡he restriction
requirement ror cxamil1:ition in the parent application).
157. liaving revÎcwed the me history for Dr, Lin's '349 palent, and based on

my understanding olihc subject matter of

the claims assigned to the various restriction groups as

informed by Dr. Lodislls expcri report (Lodish";~ 524.53Ü), it is my opinion thrii ¡he
iipplic¡¡tfons givíng. ris'~ to Dr. Un's '349 p:l!cnl were Hid ,ifier the Exrimiiicrs' July 1986
resiric¡ion n:quircmenl ¡nihe '298 application and contained claims drawn 10 the nOI1-ekciCd

invention or inventions and not to the Group il invention elected and prosecuted to issuance in

Dr, Lin's '008 patent Therefore, it is my opinion that the :ipplications giving risc to Dr, Un's
;349 palent s¡H¡sf~' the "lìlcd as:i result of' requirement for § 11 i protection even though ihey
¡in: nOltçchniçaily ¡,ilx;ICJ as dìvisiol1iil ilpplíc,¡¡ions.
15:\. Eb:i:,vlicn:: ¡Illiis rc¡wn, ivlr. Sofocl;.Olb opines ibm claim 7 o!'¡h.. '349

pai¡;nt "broke conson-ince with the July i 986 restriction requirement ihal rcquín:J ¡ill process

claims to be prosecuted together in restriction Group ll," :ind thui, "rals a result, the saIè harbor
provbíoiis of35 U.S.C. § ill do not apply, and the '008 patent cl¡¡ims arc available fordoublc~

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pnienting purposes agaiiisi the '349 pmenl." Sofoc1cous. ~ 457. This (¡pinion is llawed beciwsc it

rdies on the premise that there was:i requirement that ull process claims b\.~ prosecuted together

in restriction Group 11. As Dr. Lodish explains, the local point ofGroiip il was not "process
claims" per se, bm mther the DNA. Ludish CJ 524.

i 59. I have carefully revicwed the July 3, i 986 Olìcc Action in which

Examiners Wiseman and c;icsscr issiicd a restriction requirement ¡or the cb.ims in DLL.in's '298
application. Nü\\h\.rc in tÌie restriction n::quirçrnenl do the Ex;imin~~rs state th;it "ali process
claims ¡muslj be- rn)~\xtl!~'d togctíwr in restiction Group II:. Rather, as quoted ;¡¡)lwe, th\.
Ex:iminci; dcscribed (¡roup 11 as "Cbiiis 14, 15, 17-36,58 and 61-72, drawn to DN;\, cinssifiçd

iii Class 536, subclass 27,"
160. The Examiners' dcscription of

Group ii in tcnns otthc claims assigned to

Group II reneei:; the principle that the line of demarc.ation is drawn around :: restriction group
b~\s.¡d on the subject matter of

the claims assigned to ¡hat group, niiher than any label thai the

E:-aminer may use to ii:ièr (l ¡he gfO\Jp. Tht language Ofihc claims iii Dr. Un's '298 appliratiün
that ¡he Examiners a:-igned to Group II is set forth in ~ 148. above.
16 i, l-lving reviewed each olthe claims in Dr. Un's. '298 application that th\.

Examiners assigned to Group II, and Dr. Lodish's analysis ofihem, i note thaI these claims
included both process and non~process claims. In fact, only .l of the 35 claims assigned io Group
!i wi:n: prü('css dii¡m~, Tit,:rc!(ir\.. I disagree ..~'îili lvlr. Sdi:ìCkoiiS'S sugg\.stiütl ¡hat ¡he Joeal

point ofGmtip II is "¡)f.JL~~ss claims:'
162, As Dr. !,odish explained in his c.\perl repor!. tli\. focal point of

the Cmup

II

cJaims

is

DN:\:
'111C Examiner described Group 1135 ;'druwn 10 DNA," Based on the subject milner of the claims assigned to Group II, I ¡:grcc

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with this characleriz,1Iion. The claims assigned to Group II
included both process and non-process claims. .n1C common featurC" of claims 14, 15, 17-36, 58, and 61-ï2 is ihar each claim

requires n specitk, puriilcd, and isolnted DNA sequcnc",,
encoding either human or monkey erythropoietin ('r on analog

polypeptide rclaicd 10 crythropoIttin in both slriJc!urc and fwiciion. While some ofillcsc cl¡itm~ Me din::cid to Îlo~t çdb
coniaining or processcs using such purified ¡ind isolated DNAs.

nonc are directed 10 erythropoietin pol:ypepiidcs or erythropoietin pharmaceutical compositions. Nor do any or
these claims relate to host cells or processes for use dctìncd by

structures other ihan the introduction of puritied and isolaied DNA encoding the desired polypeptide. Additionally, these claims do not relate to cells or processes defined by a required production level for ¡my polypeptide, Therefore, hosed on the subject mattcr o1'ihe claims assigned to Group li, it is my opinion that ¡he focal point of Group i i was ihe redid DNA.
Lodísh~' 524. Based on Ik Lüdí:-Ils opinion 11m! ihe focal point oJ'ihc Group l! cbinis is DNA,
and not process cb.îJls (as opposed 10 non-process cI,lims), i¡ is my opinìon ihm ¡he men: facl

that '349 claim 7 is a process diiim is ¡rrelcvant 10 determining whether that claim Î$ consonant

with the Examiners' restriction requiremeiit For this same reason, the lact that '349 claim 7
appe¡~rs 10 Mr. Sofodco\Js (a non-rcclmiciil cxpat) to be "very similar" to other process claims.

tluit wen: lied (.inJ rater c;incdlcd) in lk Linos '381 appJicaiiol1 (SotÒckmis~: 454) ¡¡lso is

irrclevmii to determining wheiher ;349 claim 7 is consonant with the Examiners' restriction
requirement,
163. Elsewhere in his report, ¡.-i So1'oclcous asserts that 'Tlaim ï o1'ihe '349

applicaiion reciles a 'process for producing a polypeptide' similar to the restricted Group ii
c!::ìnis 69-72 orihe ':298 application (which1 recite '¡i process ¡or the produciion or a polypeptide

. H comprising. . hosl cells.'" Sofoclcous 'J 453, Then.' are a number of problems with this
argument. First, !\.k, Soíi.icleous mis(haraClcrizcs ili: ie:;t of'349 cl:iim Î. As is pl:in from ihe
text of the ebiln. whidi is set fonh in ~¡ i 5'1, above, '349 d:¡im 7 docs !lot n:clte th\: words

"process I'(-Jr producing n polypeptide." Nor do any of

the other claims of Dr. tin's '349 paient
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Second, It.)!' ihe rc;.s.ons dcsçribcd above, ii is. irrelevant 10 the consonance determination that
'349 claim 7 and claims 69~72 of

Dr. Un's '298 application urc uti process claims. Finally,

because ull Iimiiaiions in a claim are relevant to defining the scope oCthe claim, it also is
irrelevant to thc consonance detcmiination that, by using ellipses to omit the bulk of

the claim

language (including :.;mc orihc vcry limiwiions which diITcrcntinie ihesc claims), Mr.
SO!"OCkOllS caii create the misimprcssion tlwi '349 claim 7 Îs substamivcJy similar to cl;ims 69-

72 orDr. Liii's "298 iippljç;:tion.
164. Dr. Lodish examined ihe substance of Dr. Un's; 349 claims from ¡¡

technical perspective and concluded ihal "fnlonc ofthi; claims ofthc '349 patent 'cross ihe line
ofdt:mUfclltÎOil drawn around restriction Group II, 'drawn 10 DNA.''' Lodish~. 545, Dr. Lodish
cxpl;ined why his opinion w:is not inçonsistcm with the fw.:t thai some or

Or. Un's -349 claims.

¡,ce¡le the ¡crm "DNA";

Although '349 claims 1-3 redic "DN/\ encoding human erythropolctin" they do not cross ihe line of di;l1iircation dnmn
around the Era DNA inventions or restriction Group II because

the '349 claims do require thaI the EPü DNA in the vi;rtebratc
cclls be iSOlaitd or purified at any timc, R:Uher, the DNA

encoding human EPO in these vertebrate cells merely needs to
bi; imnscriptionally controllcd by "non-human DNA

scqtlcm:cs." This interpretation is confirmed by the Fcderal Circuit's holding ihat '349 cliiims i~7 arc infringed by a process
iising "gene activated" ErQ DNA, whcri;in the ErO DNA WIlS never purifieJ or isolated, Amgtlf ll1e. 1'.1!o(~ch.i .Horion
Rousse! fne., 457 F.3d i 293. 13 i 7 (Fed. Cir. 2006).

Lúdish ~ 547. For the rcasons explained in Dr. Lùdish's e;.pi;rl rcpon, it is my opinion that J101li.
ofihc ckiims otDr. Lin's '349 patent cross the line o(dcmarcation drawn around ihe Group 11

invi;ntion cli.cted by ¡\mgi.ils counsel following ¡he E.\amini;rs' 1986 n:slriction rcaiiin..mcni.

165. Equally impOrliml, Dr. Lodish cxamini;d the subst.:ncc olDr. Un's '349
claims as compared to thaI olthe original cliiims in Dr, Un's '298 application and concluded tllM

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u!l the '349 claims, including c1aini 7, Ρill within ihe scope of

Group LV, one of

the restriction

groups no! ckctcd for cx,miin:iiion in the e,irlier '19ll application, Lodìsh ,~; 54'1-547. As Dr.
Lodish explained in his report:
The-cdl claims oror. Lin's '349 p¡tent are vcr:,' simibr to the Dr. Lin's original cell c!ainis that were assigned to restriction Group IV in the '298 npplication. Both sets of claims cover the s;imc iypes of cells (vcrtebr.iic cells), and rcquire ¡he same EPO

production capabilities, The difference bciweCnthe '349 cdl claims and the original cell claims assigned to restriction Group
TV is that original cell claims (numbered 42-46) did not include
any structural limitation regnrding the contents oftlic cells. ...

There/ore, it is clear ¡hilt the '349 claims îaii within the scope of

restriction Group IV and do not rail within the scope of
restriction Group II.
Lodish -¡ 547. ~111c Ianguuge of the claims in Dr. Lin's '298 applic.ation that the Examiners

assigncd to Group LV is set forth in ~.148, ¡¡hove.
J66. Mr. Sojocleous nppc;l$ to suggest that be-caus\: '349 claim 7 is a process

c!¡¡irn and nO! n product claim, ii is not consonant with the original Group IV claims in Dr. tin's
'298 ¡ìpp!ic;¡¡iol1. Sol()cleOllS ~ ,i55. Ibvîng revlcwed each otilw claims in Dr. !.n's '298
application ¡hat ihe E\amin;.rs ¡bsign..d to Groups i-VI, i nOle- th,n oth.:r rcs:iri;.¡jon grülips. such
as Group 111, also coni:i¡ir:d product claims. For this fe-(!SOn, I do noi agre-e thm the loc¡¡! poil1 or

the Group iv claims is "product claims" (as opposed to proccss claims).
i 67, Moreover, Dr. Lodish has cxp)¡iiiied that the local point of

the Group IV

claims is

cells:
The common tcature of c1iiims 42-46 is tliat each claim requires

,1 vertebrate cell that produces the large quantities of erythropoietin polypeptidc required lor the practical iise olthc
protein. 1\'10rço\"çr, tlle celis iii Group!V :ire disiinct from the cells in Group II becaiise tht GroiiI' IV cells do not n:quire ihm

¡hey be transîecicd Of transionncd witli txogcnoiis EPO DN:\. Therefore, based on the subject mailer of the claims assigned to Group JV, it is my opinion that the fÖc;i! point of Group IV was
the recited celIs,

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Lodish ~ 529, Thus, for tliL' n.:~~sons e,xplaini:d in Dr. Lodislls expi:ri ri:pllrt, it is my opinion thm
all the claims of

Dr. Un's '349 patent, including '349 cbill 7, are consonant with ilw cbims in

Dr. Liils '298 appiiçütion ihm ¡he Examiners assigned io restriction Group iv, and ¡hat non.; or
the '349 daims cross the line of dciiiircat¡on dr;wn around the Group !l invention dccicd by

Amgi.Jls counsel iollowing ihe Examin.;rs' 1986 restriction requirement.
16S. For ¡he reasons discussed above, it is m)' opinion that safe harbor

provisionsor35 U.S.c. § i21 apply to Dr. Lin's '349 palent, and that Dr. Un's '008 patent

claims cannm be used fordOtiblc-patcnting purposes 10 iiiwii¡datc Dr. !.n's '349 !niteiit claims.
In connection with my tc,stinioiiy regnrding ihis opinion, I may use cel'ain graphics or

dCllt)f1stniiivcs, such as those included in Exhibii 4 10 my report.
3. Dr. Un's '349 Patent Claimli Arc Patcnt:ibly Distinct from Dr.

Un's '008 Paten! Claims '

169. In his report, Mr. Soloçk\)us wndui.ks that "the ':;':9 p:itcni has not been
termin:i1iy Ji:;(:J¡imeJ ovc" the '008 p;il\J1t, ¡liL'r~~by illprop~'rly cXkliJilig p:itent proiection

.ippro:\illliidy 10 /, ye.irs !x;yond the expira!Íü!1 (~l¡lic '008 puii.nt:' Sojodcüus -l 458. \-If.

Sofoclcous also includes in Exhibit C úlhis report two unnumbcn:d demonstratives, both titled
"Term ofAmgcn EPO Paient.s," which gniphicaiiy depict his conclusion ¡hat Dr. Lin's '349

p¡itcnt improperly extends the term orpmem proteciion for Dr. Un's '008 prncm. Even ir§ 121
did not prohibit use oroI'. Lin's '008 claims for double patenting purposes against Dr. Lin's '349
chÜms (which it docs. ¡or the reasons L'xpl;¡îned above), ii is my opinion that 1vlr. Solodcous's
conclusion in ~ 458 :md rdaicd demoiistratives is lllSllppUl1cd bi:c3use it &::pcnds on ¡hi. unsiated
.ìsswnptioii t!i.H the claims of

Dr. !.n's '349 piìCllt ilrc not p;iicnwbly distinct from the cI;iims in

Dr. Lin's '008 pateni - an issue that Mr. Sofoclcous did not address anywhere in his report.

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170, Moreover, based on the expert report or

Dr, Lodish, ii is my opinion ¡hai,

in addition to being unsupported, Mr. Solòc!eous's conclusion in ~ 458 and relate,d

demonstratives is wrüng. I have been informed thut '349 claim ì is the only claim orDr. Un"s
'349 patent ,isseried in this case, and the only '349 claim which Roche coniciids În invalid fÒr
double pmi:nting over Dr. Un's .008 pment claims, ..\s Dr. L,idish i:xpl¡iitb În detail iii his expert
report, '349 claim 7 is pateniably disiinct from the claims orDr. Lln's '008 paten!. Lodish ~¡~

425-432, One ofthc distinctions Dr. Lodish discusses in his eXpèrt n:pon is ihat "'349 claim 7
docs. not require transfcctcd EPO (or EVQ analog) DNA, the key e!cmênt of

the '008 claims."

LoJish ~ 429. Other dis.tinc¡iol)s between the '349 and 'ü08 paten! chlîms also ¡,n: explaned in

Dr. Lodîslls Çxpcri n:port Lodish ,:~' 430-431.
J 7 ¡. As noted curlier, the obviousness-iype double puwniiiig Joctrine is

designed to prevent improper iiincwise extension orihe p¡neiit right b)' prohibiting claims in a

laier patent which are not patentably distinct rrom claims in a comrnonly-owncd earlier patent

from enjoying a longer patent term. Because. for the reasons discussed in Dr. Lodislls expen
feprin, the claims in Dr. Lin's '349 patent Ilre patentably distinct from the ckiíms: in Dr. Un's
'008 PUkl1, the '349 p¡¡!(nt c1;¡ms ,lo not c\tend the term ofpilcnt protection !()¡ ¡he '008

pillcll,
C. DR, LIN'S '933 AND '080 PATENT CI..\IMS ARE NOT l!'V,\L1D ¡.oi~

OBVIOUSNESS-TYPE DOUBLE PATENTING OH:R DR. U¡.'s '008 p" TENT CLAIi\lS
i. Examination History of Dr, Un's '933 ,lIltl '080 Patents
in. My discussion olihe cxnmimiiion histories of

Dr. Un's '933 and '080

pall..nis begins with U,S, l'¡iient Application No. u6il i 3,l7S C.¡he' in application''), Dr. tin's
'173 application was med 01\ October 23, i 987, uncnhc restriction rcqiiîr~ment that was çntçn:d

during cx¡imîiiiiion of Dr. Un"s '298 application. The; 178 application was fied under 3ï

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C.F,R. § 1.60, which penníl1cd Amgcn'scounsel!O file the '178 application by submitting a true
copy oftlii prior '298 application, including a copy ofthc oath or declaration originally fied in

Dr. Lin's '298 applkaiion. In keeping with ¡he carli::r restriction re-quire-mem. i\mgcn's counsel
çancdkJ all c!;iims ¡hat hclongcd to n:strlclion Group II (which were being examined in Dr.

Lin's '293 application), and selected original claims 1- l 3, 16. 39-4 1,47-49, and 55~57.~~ which

belonged to restriction Groups i and V - for examination in Dr. Lin's' 178 applicmion,
i 73, On Febniary 28, 1994, Amgen's counsel advanced the examination

leading 1Ü ihe '933 :md '080 palCl1S by iìing U.S. Pmeni Application No. 08/202,874 ("¡he '874
;lpP¡¡~'mion"). Dr. i.in's '874 :ipplic:niofl was tikd under 37 c.F.R.. ~ 1.62 and utilized \VIHlI WilS

known ;is ihe "iìk \"nlppcr cOrHinuing" proccdiiri.. As a rcsuh of filing iile '874 appiicaiion

under 37 C.F.R. ~ i .62, the prior' 1 78 ;ipplic-iitíon was abandoned, and its spccilicaiion, claims

and dmwings, including all amendments, were carried forward and "continued" (i.c" physically
included) in Dr. Lin's '874 iipplbitîon, Dr, Un's '178 applíciiiíon provided continuity lanlle

'874 appJic:iiion to permit the '874 applicaiion to c!aimihe beiiefii of

the lìing date üfDr.l.n's

'2% application tlnJ~'f 35 USe. § i:?:.
! 74. On June 6, 1995. :\mg¡;¡ls COtJf\Scl3dvancl.d ¡he eX;liiin:ltion k:¡dìng 1ü

the '080 p:ilcll by tìing U.S. Patent Application No. 08/468,556 ("he '556 application"). The
'556 application waslìed under 37 C.F.R, § 1.60, a provision oftlic USPTO Rules ofPmctice
wlikli permitted i\ingen's counsel 10 file Dr. Un's '556 applicution by submiiiing;i triic copy of
the prior '374 :ippiîc:.níüri. including a copy of¡lie oath or dccJaraiíon origimilly filed in Dr. !.n's

'87.¡ applic:lIlon. Beç:iuse Dr. tin's '556 Uppliciliion was tikd under 37 C.F.R. ~ 1,60 and no!
Illid~'r 37 C.F.R. ~ i .61, ming orihc' 556 application did not automaiically result in abandonment

(¡(the prìor '874 ;ippliç¡ition. The- '874 and' i 79 applications provided continiiit)' for Dr. Lin's

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'556 ¡ipplìc:i:iiüri 10 iy.:rnií¡ ihe '556 application loclaîm ¡he bencli¡ ofilic filing date orDr. Liii'S

'298 :ïppJicalioll under 35 U.S.C. § 120. Clrinis ó9-ï5 ofihc '556 applic~iiil)n were ultimately
allowed by iht Examiner on January 6, 1997, and they issued as claims 1-7 of

Dr, Lin's 'u80

pawn! on April 15, i 997.

i 75. On June 7, 1995, Amgcils counsel advanced the c;.;ï!liniition k'itding 10
¡he '933 patent by lilng U.s. Patent Applicaiion No. 08!4Sì,ì7'¡ ("¡he '774 applicaiion"). Lib;:

the earlier '874 applicniion, Dr. Un's 'ï74 applicaiion utilized the "tile wrapper continuation" procedure under 37 C.F.R. § i ,62. As a result, the '874 application was abandoned, and iis
specification, claims and drawings, including all amendments, were carried forward and
"continued" (i.e" pliysic:.lly included) in Dr. Lin's 'ïï4 application. The '874 and' i ï8
appJic;itions provided con¡imiitj' for Dr. Un's '77'1 applica¡ion to pcnni¡ thi: '77.1 application!O
claim the !1L'"rieni of

the lì¡ing dute orDr. I.in's '298 :i:pplicution under 35 use, f 120. Claims

LOO-! 13 of

the '7Î4 :ipplÌi:¡itioll \wle uliimately :dlü\Ved b;.' ¡he Ex:imiiii:r on t\bn:h 14. 1996,

and they issui:d :iS claims 1-14 orD!". Un's '933 patent on August 20,1996,
176, Bec:iiise Dr. Un's '774 ¡¡/ld '556 applîciiions both contained claims drawn
10 the inventions of

Groups i and V o1'tlic restriction requirement in the '298 upplicaiion,

Amgcn's couiisel voluntarily filed a tcrniÎnril disclaimer to ensure that the end ofihe tenn of

the

'080 patent coincided wiih the end (lfthe term of

the '933 paten!. (5iee '080 File ¡-isiory, Tab 5,

12!20i96 'l'i:rmiiiaì Disc!:imer (1\M-1'1C 00(41986)), Examiner ¡i.l¡lrtindJ stati. in the IiiI.
hisiory ¡hill he W3~ "Üivorubly impressed" by Amgcils Voluiii:.ry decision to li1c:. tcrminai

discJ¡ïimer. (See '080 File History, Tab 4, i Vi 1/96 Interview Summary (AM-ITC 009'¡ 1(82)).
i 77. I may use ihe following table in my testimony in light or

Dr. Lodísh's

cxpcn report 10 cxpl:iin how claims i -8 of Dr, Uii's '933 patent n;l;ic to the original cJ;.ims in

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Dr. Liii's '298 application that were

assigned to restriction Group I;

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R rentative Original Group i Claims '933 Polypeptide Claims
, ,

i. A non~iiatural1y occurring erythropoietin
'i' 1. A purified and isolated polypeptide I conjimnaiiün and one or mon:.' of ihe
i

. having IJim or alt 01 the primary structunil

glycoprotein product having ihe- in vivo

biological aciiviiy OfC:ìlSîng bone marrow
cdls to incrr:asr: production oÎrdinJiocyl:.S

i biologk;il propcnies of naiurally-occurring
! ;;rythropoiç¡in :mJ diarw,:¡erized by being i the product olprocaryoiic or cucaryoiÍ\
expression of an c.'\ogenous DNA

and red blood (tlls and having
glyçosylaiion which differs from ¡hat of

human urinary erythropoietin.
2. The nOI1~naiurally occurring (PO

sequence.

40. A glycoprotein product having a
primary structural conformation

glycoprotein product according to claim i

wherein said producili:is a higher
molecular weight ¡him human urinary EPO

suf!ìcicritly duplic¡:iivc oîihai of a

n.itur;iiiy-oi;curriiig erythropoietin to allow

as measured by SDS-P/\GE.
3.:\ non-naturally occurring glycoprotein
product ofib\: ç~plcssinn in;t ninmm;ilîan

pnssçssion of onL: or mon: ofll1(' biological

propcnks ihcrçof and !i¡ving an average
carbohydrate i;omposiiioii which differs

trom that of naiir:ily-occurring
erythropoietin.

host cdl olmi cxogcnous DNA $I.qu,-~Ilcc

comprising a DNA sl.qucncc cncodîng

human erythropoietin said product
possessing the Ùi I'í\'o biological propr:ny

ol causing bone marrow cd!:; to incn::usc
prodlKtiün ofreikulocytes and I'd blood

cells.
4.:\ nOIHHllUrally occurring human

cryihropoìciin glycoprotein possessing tlie

, in vivo biological properlY of causing bone
,

I marrow cells to inCrC¡lSC production of

I reticulocytes and rcd blood cells which is

¡Ihe product ofilic process comprising the
,

I sirps of:
L___~m'
! t¡ii ~J()\\'mi.. iin()~'1' ~iiitii. t tHllri..¡¡t

I , ' , 'bl '

"',.'""_..'-'"__..._ _'"m_.'''''._____"__"_.__.~._.."

84