Free Claim Construction Answering Brief - District Court of Delaware - Delaware

Case 1:04-cv-00874—G|\/IS Document 136-2 Filed 03/24/2006 Page 1 of 4

e s2 = T T " " 96; ; ‘* * r*E » % ur t O : 4; r·ue2r rs
Q . , , O. ;;c.&-it; · .—‘ A,. :2;; ‘ -5 _s _: at o
O " ‘ ·—W_ `‘`*— it ·- “ ·.1
.. ` c I ri iw —. _‘ Z` I -_~. I h
_ E f YF ` é " Q 1
O `· A &_ WIP B°°’° ‘. ’ » ‘ ” ~ ` .
O O a O r t
O ‘ Original Eighth Edition, August 2001 g T _
O O Latest Revision August 2005 . gt O ~
U.S. DEPARTMENT OF COMMEREE _
United States Patent and Trademark Office 2
· Loérzl-703—426~O633 Fax-703-426-0833 _ ‘
i WWWMAHEUPUBLISHING.COM

1 * . 093 - ll _!•..n.:.•. To • A 006 Pa e30f4 _
2111;:: = MANUAL OF PATEN’I€-E>rAnw£1NH¤G PROCEDURE
situation;·1expe1is·iet the2·FDA:have$assessed6tize.·ratio—1 is- no knowrrcure for adiseese, however, cannot serve-
n"a1e?sfor‘ihe drug ‘or=·resea1+ch¥stnd3i¥eg¤0n;s2vhioh.san as-the.`basis··for a eoxaelnsion that such anvinvention
asserted .=uti;lity ais' based .-and--·fonnd&" ·it ·satisfactd1°y: lacks utility. Rather, Ofiice personnei must determine
- Thus;.irrchalienging.ntiiity,·0f{iee peassonnekrnast-be it`,,the; asserted,-:u1;iIity,__for .the:.ini{ention iseredible
able.·to}-carry-·rheir’burdene that thQl'B-iiSLHO=$OUlZl€1IH{iO:- basedop tlie-information dis;;losed,in,j:l;e_applieptiori;
nale-for the-asserted·-utility‘everithotigh; experts-zdesigé. Qnlyetiiose claims for yqiiieh-gan asserted ntility-.1is-_nogi
noted by Congress decide the issue Have éfome.·to·an‘ cre_di'ole shouid be rejected. In such cases, the Oiiice
opposite_¤c.one1usion.="FDA·epp1:oval, lioweveséis-not should_-earefnl1y,re;giew,,what isjqeixig elaimeqiby tthe
a-prerequisitedor Ending a-·e0rnpou11d—- usefui applicant; _assertion_iliat;-die.elaimed-,j,nyent;ion_.is
the 1-560;.·34..USPQ2d= i43.6.(Fedz·.=Cir;g`:1995)z(citing.iS'coi‘t, may beeonsideged. eredilglegby a-p,erson,of oigdixiary,
. afienege-Sei-3d-i11583-1*€163i 32 US‘PQ2d¤‘1-115§1120 s§ QFed;§Cjr;:1-9§¢§)).·Y-: .- -¤~ `- 5:-: ..: of eyidenegorlsupgorg-In_jcontrast,; angssseriiong
:-¢es¤s,·-eis1e;es=`-apeaeesr- easy-‘es·-seessies-··sees--ee· ¤11e:¤1¤im¢¢. ievs¤ti¤s; >ri11.=¤¤-;¤ss=1‘=11 ss;§¤¤ess’§·..r-tie.
pas-ise=·ev1desee re show ihsereeeaseesees siese disease may require H Sis¤it1¤e¤i1y;sreet¤se-mauve-<>;€
se eiaesee; se-·ie··issp£ep_ee -ser--‘oeiee{ giesseaieeiere- 1*=*»fi¢~‘=i¤¢i¤1¤y;.s¤11>1¤¤1?¤ &¤·_;be.s¤sSis1¢¤¤d .—¤s¤Qi!¤l¤- by e
- aeqeee ev1eeiiee·-ssssreiy-ie=e1e eeaeieie esseeess, pssseest- 9{Fl?}*?{°?¥Y;.Sl$m. is -11:1s. ees lore -mer.,-ses
ee eegeesssg-·¢rse ·=-= seg; · ee1es=eeeeeeesess.>·see-‘=1s-em E-2d..1;15%e;.19§-USPQQQQ--<§$.GPA -1?7?>a ieee Je!-ke.
seems,-‘5esss.2a*11=s4;=i9s-USPQ2i;e>(ot;1>i$;-1¤9vvg;= 628 F-Zdcl-322-.-.206 US1?12 885 ieee- Haffop; s=1·i=e.22i zéisgnas eosieej si-9-sleeps- Ex Pere F<¢r2w<2¤i 11.71-USRQ 2‘29.€B§rP¤1>—APp--;§¢;
ies;z);‘?ie_>·é Aiii‘F6ziji,*`?l‘14*iF.2d-il$8-32;-l_62‘USPQ?-59?§` inter- 1957)- =¤ - · - ;_ · · ;=
(QCPJ¥?I9‘69)";¥:i ¥·é*‘Fwrsorz",?517 F.2ii=>i%5,-1 B6=U-SPQ -111. these. cases,. it is irnp‘o1·ta;i1;;to:note that sie Food
1-1?9?Z55;,-In-_?reeKPiini>ie1; ii!92 ;F.2‘d ¥945&;:3s§ 0: and-Drug Administration has-proznulgated regulations
2=l5“E(CCPA :.1 96’l)§?. Exé.pzi§i·f;e‘e‘,3’oi5¤Fi2§vii5.s€,* 21.1. that; enable a party toiconduetclinioal- trials- for drugs;
USPQ‘-9'0*i*(B`d. 12at. -Piiijé.-2’3e.I1Etei?!I931§‘.`Ee . . used- to treat lifeihreatening and-severelyedebilitating.
_ -?; .‘.. - ‘‘¤- ls?-ér...¤.·f‘{* zisi?.lr-·=i=.°E2‘i-`!=· ’ illnesses;*even..where-,-noraltemative therapy exists.-
wese:intnnr-i1#ivmNT-s"*0n.§.·;.sPncns1Gisoisnissn See;21 GER.3.12;8DaS8 @$394); Implicit in;these;regn—-
CONDITIONS · _ {ations -is;the érecogni1:io‘n-*tl: -- e€31ai¤¤S-idncciedsteraimetiimi ¤f--treetiils.-srisneies s $:1
d*S¤=-ee fe -wh1·=1= um here 1¤=·=¤ ¤¤ i¤¤v1<>¤s1v Sue eiS.erss-ies rseiseieesiees pier-repay.sseeeasie1u..
oessful treatments or cures warrant earefui review for ,i6SSBS_ -,ThuS_. ag;da.,.i{__,Bvidéuc5A from mpcds-._m-ma, _
°°mP1*“”°?1Y“‘*h·35 U‘·S4‘C· 11011 ·=T*¤=f°¥¤d1bi1i1Yi=¤$¤¤1 art indicating-that there is a reasonable expeetatiornof
assertedruulity for- i:reat1ng.:a·hurnanidisorden.-rnnyi.be: Success, Suppmtcd by Sound masming;;uéuéuy_ShD,,ld,
gui` tcggggk ;°;St“t;’l1ti"·;W1¥8§* °‘j'?€;l** S‘¥*€Tg“§°` be sufneientfte. establish that-suc}1:a¤1tility-isnredibie.;
n ers g- u ges a--rsue =e,=es rwou — e _ _, ic. . ___. , 2 L,} . _:_A_ I __._ .-_
impossible. Sucl1·a;‘determination;lias··always.required- 2111, _ Qlaim , Iprqypgetgtiqg; Bg·q;;g1g§t_
a gDOd:.L`[email protected]{3IidlIElg`Qf the:state‘.0f;tbotart·as‘.uf the it Z . . Reasonable Interpretation _._ _u:_ Z
nmesthaig-tl1e·mvent1on was made;;Eonexa1rip1e;·pr1on . _. _; _ . ,_ ,._,_ ._ , 2. ._._ it-
to;-the-q1980’s, there-were ED‘11lJ1I1b€1'-Gi; oasesrwhere an CLLQMS MUS} BE
HSSB1’f€d HSE RE
as · "inéredibie.Z? ;.In.--i ree-Jalies,i.=,r¤62i§-;;F;2die *lB·22§‘ _ --_ g. ;__;j_ egg, _,_-. -
206·US1?Q~8-8&(CCPA; 1-980); Infe Bering, ·¥1l8·Fr2d During patent examination, the pending claims
540;:}.63. USPQ;6S9 (CCPAsil969); Exrparfe Ste11eiis,- must be Fgiven *>their<-broadest=.reasonable interpre- ‘
16a USPQ2d·‘1379 i(Bd; Pat; App. &.-Inter; i1990);.Ex- tation consistent-with the specincationfi >In me Hyatt; ,_
peers Busse,_=1-USPQ2d‘-1:908-(Bd...Pat;·App;;M¥c;I.nter. 21-1- F.3d $367,-~1372,·-54 USPQ2d:. 1664,. :1667;.·(Fed;· _
i¤986)j Exzparte Krepelka; 23l‘2USPQ 746 .(}3d.iPatQ Cir.- ·20()O).<·Applicant always has the-.opportunity:‘t0- ¢
Appe & Inter. ;1986);€Ex parte Joyariovics, QJLLUSPQ amend the elairnsiduring prosecution, andrbroad iI}t@1;·" - =
90*E·.(Bd.‘Pai.1App.:8e Inter, 1981);-·.'I?he.;ifag§t.t}1atthere pretationby the examiner redocestiie possibility that {
Rev; 3,·August zoos- 2lOG-46

. _ _ - ent 136-2 Filed 03/24/2006 Pa e 4 of 4
- ,; . s = 1 .pArmq¢rA_r31r,rrY.- -: 2-111401.
thei:cEaim;·¤o¤ce..*issued,‘iwiii·"be iriterpreted·o‘more "resto1·e·>11eir growtlfi to! smeazr:. that- the- claimed
broadly-·thm¤·isjascteed. -In··re Rraaa·,.41s me 1393; maeqaa_;aic;aaSes,taa guages: gf haagmam.;-Ja the
l‘404~95‘,?’ 162: USRQ=: 541; ;550-5*1 .— ;(CCPA . .1969) scaIp; (Claim 9Was directed_;to·a procewzofiaxialyzizig data hairjt i · -: - . · . "?*" " C *‘v ‘ ` . * -·
e¤erated·by.m·ass.;s`eetrogra hiotaualysis ofa gas; ; a_._.·;; . : .- .
"iho eroccss comprisgd seiecuig the data totbe aua— Zulegi i*~i*$amUg~·[RT'3i_. sr
Iyzed by subjectirigthe.·data-toa=maHiematioa1·.m%mjp- .; ` . -. - ·~» ¢ ·;¤.:., .
alatcion. {Thi?:bXiiII1iI1€f’T*1}1&dB-?i;B_jBCiibI1S‘l1i}dBI;.3‘5 I- -·—- ..WQRDSi QF A GLAIM:.MU§T...»BE·
U.s.c;—. raeaaatioze raise asezszesttiozaajaaseat. €€BLAIN:21\4ZEAI§¥11iG$?.;:-Iliic
ttici é¤ia1r1ioér·ex§11ai¤ed=that·the clairmwas-aa:ioipa1e·d ;
by-»meata1"§¤ro‘cess€aiigmentedcbypeaoii-aodtpajpei ;;·~v$?EClFI€AHQN.==1:--- . .··0 ·;. · :e .»¤..;

Ssa¤a»aia~¤=e1aat ata :·aar·‘aap1t¤iey sair-raiemaa. tgt?-QE E iH‘?°¥ 3 .—
aaeasaaeeaaam light ot the speciticaaoo,. to ¢iaereby=tozérpres -mates-. p¥?°i?t}?9=;t? ·- c °* EER} >`¥”?g·=??iai¤i?a‘-i$iii’ S. gr
._`` .. .. . —. . ., . BX8,H1,§13t10H,.tI1BrClB.1I}1S_ mustbe mte1‘prete§l·_as
“°”S °"*Pi‘°‘““' ”i°‘*°d’mL“*° °""“‘*° ‘“‘“‘q‘t‘*'·’ ‘m`“°“‘ s}s`asiy¥§S’aiaa-iié2asa‘i¢éas¤aaa1y°aiisaqia aé‘Laae;¤sr
wsgitimiie‘*¤ad*¤g.:‘¤*i*¤“°¤a.. tt the `stmatsn an eases. ieaat- »·eaat—s;a—
*¤¥°`¤ °'e‘m·* ta ?i*€**#’¥’Y’*1i‘?*°W"h¤‘i°"°i’*’ *’f*ii*°>’*"a*i¤ ess-13ea’:’$)o ussoéa teas-· isséfiitédieaq zadéaé
bi ¤?¤¤P1i<=t=tYFatima1dit¤1¤¤¤d*.1ie¤*¤¤¤as¥ir**¤§*=h‘h¤**°‘ (sia-’i3sp¥o site a‘siasieai’srai&Lhaéa1.faskésiisihiag
liUi'€$€pIé$$`ibH$iS‘i11QthB`CIHiIh.” The ·CDI.I1’I;`·f`(ji1ii€{iYtI18t chili] ga le;
aPP*"°¤****’tg‘¤d‘f°°?**“¤ith¤"i“é*·’*<¤%>`*¥?¤·‘*·**¤P’éi**¤ii*· Disasters esieo- asa anaaaétaea saaaésé
· S*“i*‘#"*ss¤°f?#?ii’¤’6is*biséts¤i¤“t* ms *h~‘=‘$P¢¢iHF¤‘i aa;saasis‘=aits5aisasa;ji· its aittaa; ieiféa
““¤`i¤*·*i‘*té"t¥`**“i*=?4"S¢¢’t’$°"1* té *t’°**’*’»‘ *m`t*=3d sista-ataa1.aasi11sa sas was
I‘¥"8?".°?‘*·5‘5··`“4°sUSPQ2¤‘10234 *°2"*2*‘ i997>’i“i“é`*°i¤**`ih°1“?*h** *h°='PT°iS‘¤¤* *é *h*’5*’**iSée°* P*i**€°“*1“#¥‘*6 i¤*¢*¤*s*‘°'é*¤tS`ii*i*iPP”·i me tee; (aaa§saa·‘taiae5;‘ aaa
etisas is the ssswaasss as a we aaai iateee .aa£as·f·ras2= .2iiaas;=a»a»aa,1‘·1aa.;ess z*¤‘;1s~zi; i
ciems ..‘‘ i #1* a**‘?@€¢¥%t¢¤?:.$¥*i*- iFe**i©t·.ii.:FbeZ."P'FO ism-’ ·sé"usr·<§§a"21§si¥{pea; oa. 2d aI$Pii€t°'i° éiii*?@€*.i9¥€ui‘?'§P}T°ii¤iS°‘i ¢1éEi¤1$"@*i€.b*°¤d· Sif§pié‘-·‘si5éi;$ii eQei¤as‘*t}.»eb%§·`¤aeii2ii1ig”t§·?c!aaé’iaiaéi`
¤$*‘*éi‘·S¢H¤t>*¢. méesiaaittthe ‘*1ei¤¤,;i·i‘i*?¢?s`¤¥*’i1¤a1v as~qssaiaaas1aj*aa·ssataaixiaaieairaataar‘eea sees;
usage as they woi1Id¥be’11iidersto6d byooe ofbrdioary 3 ijmiagahu;.Ebhéé)&._.éHaiégé§.·iHéH ‘iié£ji§g’·.aeé*·b6¤;
std!} ia Fas tease. *11*6 west wsaazvst assets- steam;. ata; aaaiyiasaaae as ras; *·aaaia{g’
¢*=2f¤=i=## ¥>W?*¥_L_¤f.`¤sf?¥¤i€i¤s·#. as ¤¤¥¤¥v¥~*¥_%¤.Fs:=~z*.1s¤2=~j>* asaaaaag saa;s;;aasaa¥a‘aaga·ta ‘a*aapaaasa·-
E§;?;€°§i$2iL§;?§ai.iisi§§*?§“ ¥“iS°’T*P *‘i"~*“’“’“"* ‘“
·‘-=` · = `·‘6 Y · F ·‘-- - · · · · ihé des ,. raf sf Ulm Mi! 1¤$i P-.%¤-PYBE; YQ ..,; <’
. The broadest reasonable i;1te1prctatio11 ofthe `oiaimse beasjiiii
H1l.1S¥<°3iS0']b.G.."COHSi$¥€Ht with ·the‘ interpretation that espoeiaiiy iii `hohchemical cases, the iqvordsjii aiclaiag
those sidi1ed‘-.i¤¤1the-artswottld-ireach‘1`Jn;·re···CTorrrighz§ are generally not limited io their meariiug Bj} what is
165 aaa .1353; 1359, 49j-{3SPQ2d 1464,- I4681(FedL=` showii oi Gir.1999) (F1`heBoai·d’s ·co¤s¤-action oi-the claim tim- beZ—FIorsheira.‘Go. u,Medi-adiac., 353 F;.3d‘898g 906;
itatioa.“1:estore hair growth"—as.requiriug-.tHe hair tobe 691USPQ2dY.1.801g.·18O7 (Feds Cir. 1200Z1)(discussiug.
ret1irned.·to. its original state ·was._-held?-to o Hauer *-*. resent cases‘whe;eim·‘tI1e‘.c0uzjt expressly ·rejected¤thei
>i¤co1rect<·i¤te1pretation·ot?the·1imitatio11. The-court c01;1tentio11> that if-a patent¤cdesczihes‘.o1m1y-‘a single`
held that, »co11sistent*with.app1icaut?s disclosure and embodime1it,—the‘..elaims of thepatent-must`be»·`coh¢
the disciosure of three ..pate11ts11i·om`ianalogous arts strued as beimg·iifnited'to that- embodiment). It isoaly
using the same: phrase to’requi1·e‘o11ly someiincreasc when the specification provides definitions for terms
in hair growth; one of‘o1fdix1ary-skill wouidconstrue- appearing ih=the.c1aims that the- specification cars be
2`IOO47 Rev. 3, August 2005