PY{),tA.iAl26- (04.-13)
`ApprOV-$•::! for use ;ri,c~h 04;'3t,,'2{l13. OMS OOSHH:31
`Li.S. Patent 3M 1 rawrna,l<: Otfu:,;; U.S. OEJ-'AR.TMENT OF COMi'v!ERC!:::
`:;;;der the Papero•,;nrk i~,od:_;ci;,;,n .<,.ct cf ·i 9~5. no ::xmsa,:.s are requ;f>z~ lo resp<>f'd ~o a ~-:tJon ¢! ;nform.<>lit~- w•,!e1,,.<> :! d•s::>!ai,-s a v.i.;lid OM a ron~roi numb<'f.
`TERMINAL DISCLAIMER TO OBVIATE A DOUBLE PA TENTING
`REJECHON OVER A "PRIOR" PA TENT
`
`;::-Heu. Mat 5, 2017
`
`F,:,r. Antagonist Antibodies D;recte<l Against Caldtt<nin Gene- Relate<l PepUde and tv1ethods Using Same
`
`The aµ~>lk:-am, Teva Pharmaceufa::als irltemational GmbH, o>«1n,ef ol 100 p~rcent ,nte,est ln the irs,;,tant app!i~tlon tiereoy dis<_":lalms.
`e,xcepl ;as prc,,,,dm1 below, !'ha t&rmina! p«M. of lhe stmH!ory tmm of an,· pmer.t granmd on the fm,t.:nt Bpp!ication wnk:h 1-s.,,u!d eictef:d hay,md
`ihe exµit1l1im~ date of the fu~ si?lh.itory lerm of prior pa~nt No. 8]34,802 a~ the tmn1 ~f said pr~r pat.1-nt is presmiU~· shtntenecl by any
`terminal disc.l,aimec Th;:; apph:.:;nt ~~,by ,agre;:;s thal mw patent M gramed on th;s jnstan! appl!uati,m shall !:le enfortea~!;s on!,• for an<l d1ilir.:g
`such ~fit.<d t.r:,al it ;mq tl:,, prior patJ:1nt ;mi oornmont,, own~d, This ;;:grne~nt n.ms with any pat~m! ~,,mt;s-d on ft:e if1s;;,mt appliwtKm an.ct is
`hinctiniJ ,ipon th,, gr,mteis, its successor;; ,-;r assigns.
`
`!n making !he ab>~ve disclaimer. the app!iC<'lnt <:foe;; not ~fa,daim !he lerminal part of th,e term eif an)' patent granteti on ihe im,tanl :;ippfo::aii...,'1
`!!'mt 1>1,-.::;,.i;;j extend Iv !he expiration date of the fui! stat,.it0,-y tenn of tt!e pril:I( patimt, ·as !he term of $aid i:,rl~r pistent is pres,mtly shortemect h~•
`?lny terminal tiisc!aimer," in the event that said prior ~wnt later:
`e:,qiirns fu< ~i!ure to p;;y a rnalnt~nance foe;
`is he!ti wamiorceab!e:
`is found im.-a,kl by a c-ourt of competent j;,iisdictkm,
`i;; &t?lti.:tori!)' dl$Clalmeci iti whole or lermlN,!!y ciisclalrn,;;ci :.mder 37 CFR 1.3Z ~;
`has al! dt:sims "-<Snceled by a reei<.m,ii,alion certi11c.a,,,-;
`is re;sstied: ,Jr
`is in any manner terminated prior to the ei<;:,irati<Jn of its fuli sta!utory farm M pr,:1s,,;mtly shorteneti by any terminal disc!aimei-,
`
`Check e\U;er box, <Jr 2 t.<-ek.~"'- if .app:-opiiate,
`1 . ls] The ,mdarsignect ,:s tM app!k:aflt. !f U,i3 app!k:anl ls ,m !3ssignee, tr,.'3 undensigned ls atit:1crizw to act on beha~f of !he assignee.
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`I him,by a6:nowleiJ.9e tnat ar;y wmfol false statements ff'~'>de am prn1ls.hab!e under Hi lJ S. G. '! iXl i ;;.y fine or im;x-,s-0nrneflt cf not more
`th.an f;..:e (5) \tears, or boH,.
`2.0 The w·1de;-s,gn;;i<l is an at!cn1e-\t or agent ot" ro?~ord.
`/!:~~~f1~$ .. {.:~J2 ti:;r_~~::~.'
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`H~nmnn Russ
`MarntM Offi{:${
`
`WARNING~ informBt!on on tills form may becmne pu~lic, Crnclit card infarmatkm $hou!d not
`l:lt< included on th!$ form. f!,ov!<fo ~m:id!t card informatkm and au!h-Oti:t.atl<in ¢n ?TO•l!'.!33.
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`T:i!s ,"..<Jfa:'H,":·fa~r~ ,...J :nf!:;fffi~tic,.~ ~~ r~~q.ufrOO ~'? 37 Cf'.'R ·L32.1. Th~ iniofrtl3Eon ~s re~ui:::~ to ~~n .c:r retain u ~en~!ft bi th& pubnc W.~ i$ to fr!t: {and ~'Y !?"!e USPTO
`\c pr<Xesi;) an '3fJi:,l,~on. Cm,!lo'em,s.!l!\t is gov~m0;!.l:<r 35 lf.S.C. 122 &:\<i ~7 CFR 1.1 ·;an<!,. ·i,t This c,;:~!eclion is ee;.1lm&ied lo t~e 12 m,r.ut.:::s. to C¢rrlpicte,
`i;,,:,t:m;g gatn1S,'f!!J. p<ep<i<?°i"'l• a-<>d su!:<rr.~tli:'19 the o-;,mp!eted apl,>lic~wm k>tm ;,:, !ho.-. t:SPH). Tim.,, v;m v,HY deµ;;,Ming tit'"'"· \he ,,,,;f,,rict,.;al c..se. A.ny <.:-11mmenl~ ,1n
`the ~:101..tnt cf ~~e y~u tt):q;..~m io ct~n~ete 1.h.s f~rm and;ct sugg~sth:.iTS tt"ff reducin.g, th}'$, l:.iJJfd~"':. s~KXJki he ~nt t~ the Cti}ei h1K1:rt~~fr>!"'! O:~~er. lJ.S Pat.ant and
`Trad.,m;sr~ Ofilc<'. U !::<. ~f:,'lrlm!<nl <:t C'.<>mm«,,~, P:O. B<r,< 14SB .. At ... ~,~,,l,i$, V.t.. ,:,:M:3-14SB. QO :'.'{ff $ENO ~Ef:~; OR C(lMPLETf:i.i FORMS ·;c; THIS
`ADOR:ESS. SEND 1'0; Crnnm!sslfil~{>< fo~ l"a~'$~ls, ~.0, &x 1..V..O, Me¾;;mfri:;;, VA llJ13-1~.
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`

`

`(-04• i 3,),
`PTO/A!Al2€-
`AfJ·?:"nY~ fr..;f 1JS,e thH."?;.tgh {),4f:~tV2{Y~3. QM8 oo~·:.--0a-~i
`l.t$~ ?.at~!':t a~~ -r~;sr3!::(n~rk O~k~: U,S. DEPARTMENT or- {:Q~t\.1ERCE
`:JndeJ .,n~ PiSt:•~f).""Cr~: Reriu-::tior: Aci Qf ·i S*S.._ n•:t ~f&Ons esr,;-,. t!S..:;t:kOO tc !~pend ~G ~ cclJe-t.~·dcn i:,f ;J~c1r:r.~o:1 un;e§s :t d:$fJ!ay·s ~ vafo3 Ot..16 corrt:-0:'. m.nn~&
`TERMINAL DISClAJMEFt TO OBVIATE A DOUBLE PATENTING
`REJECTION OVER. A "PRIOR" PATEN1'
`
`Appfoc!fa:>r, N0.: 15/588,490
`
`Fl>ed: May 5, 2017
`
`For: Antagonist .Antibodies Directed Against Ca!cltonin Gene~ Related Peptide and Methods Using Same
`
`The app!ic13nt, ·Teva Ph arm ace uticals I nternation a! GmbH. m1,1n,3, or 100 J)€'rt~~nt
`:nleresl in lrie R,;;,;mt apr.~lcat,,,n t~erel3y ,.Fs\'.'J&•m::;.
`el<,c:;epl as providoo tm!ow, the iem,ina! part of the ;,t.a!.lik),·y te,r.,; oi. ,my p&i~mt granlBd m, ih'2l i11stan1 app!icatk>n which wocitd exteno t~YQnd
`tne expiration date of the fu!l staMor1 term of prlor pa1.¢nt !'{o 9,328. ·~68 as trir, term of~;,j prtor pat~nt is pmsl3,nt!y sriortened t,~, any
`terrntna! disdairnsr. The eppiic,mt herei)y .agtees that any patent ::;o granted on U1e hst.;ri! app!;<::.au,.m sha!! be enforwable only for and d;.iring
`S!X'.h perioo tha, ii and !r,e ~nor pawm are comm(cid:144)nly owned. This ag1eemen! 1un1> v,,1U1 any ~hml gr.,;nted on the im,lant aµp!katirm and i~
`bmdmg "ipon th<:> gr<mt,:;,e. its SllX~ssor!:> o:- ass,!,}ns.
`
`ln rniS!-:inij tne abo\.<e cii<'x..!aime,, the ,,pp/icant ooes not c!sclsirn the ter:;-nms! ;:,a!i of !he t,Brm 0f .;my paten! ~r;,,nted on the instanl a,i:;p!ica!ion
`t,'mt woul<i .elden!i' lo thf, expiration mue ot' Um fol! s.tat-..:tory term ,,! ihe pr~or patent ·· as the tenn of $Bid prior p.at~·mt ls prns,mtly srirniene<.i by
`any le,,ninal discJsi!nef: inc the event Um! said prior patent lakr:
`expires fur failure t,, pay a mmntenam::e foe:
`:s held unenforc.,Bb!e;
`,s fo,md inva!ld t:,y a court ,;,f compatent jurts.dk:tion:
`is statutorily di~c!.,;me<i in w!x,,e m term~,ally 1isdaim0<i uMer T? GFR ·1. 321;
`ilas a~ c!alrns canceled by a ree;,,:amination certificate;
`is reissued: or
`ss in .sny rnarmer terminate~ prior to !r.e e:q,if13tion of its f,I!i staltJtory tern. as presently snortiene,ct !J.Y any terminal disclaimer.
`
`Ctec!>: eitn.er !ms: 1 or 2 below; if ;;i;pprnp-ria!e.
`1. 0J Thlt- tmdei-signad is t~ .applicant lf trfe app!icarr! ls an ass~nee. the tim:lern,'gned ls au!!,urizerl ta &.:'.i on tienBlf of Um assignee.
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`l he!,;,~y a,:kn:0w~d11e thatarw wi!!fu! false !;\atem,mts :-r;a,je ,ui:i punishabl;:; 1Jnoer rn ltS.C. '!001 by fine or i,ilprlsomr:eflt,;)fnot mere
`than five (5) years. or tm1h.
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`2. (cid:143)
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`The tm1iensifJ!'li:id is ari a1t:0m~y w agent ;.}f tiK"'lfd.
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`l\::.::;~---f_t~~t ·t>~::f ~tt<::i~'.~:~:::.
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`\_
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`Reg. Ne;.
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`Dal~
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`Title
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`WARNING: lnrormafum ~n this form m~y ~c.m~ i:su~lic- Crndit .:~rtt inf~rmatl~n sh!)uM net
`~ lm:!uded oa thls form. P~vidl!! crorlit t:,ml infurm3tli:m and authomats~n ;;jn PTO,::Wlll.
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`Thi$. ,x,lk;;.:11,m <>~ anf,:,,:mm'i<.>,s ls ,equi,w t;y :11 (;;;:;:._I:~;?~. 11,,, :nfo,sm.$bn iis r,;<.iu:roo t::i ::,,:,lair: nrrelai;, a benei;t !,y !he pcl!;l:'°whid'l is iu f!!e iar:<l i:.>ylhe US.PTO
`~o fJff.h:::es}=>} Bf5 f.:ifJfJiicatit~1. Comkis-nt}·~:ty ~s gO'v"f:.ffied hy 35 U.S_.C. 122 ~lli ~i' er:;~ _·l .11 ~r~rJ ~- t4,. -rnts .::.~!i,et.··fa-:n is -.ssttnl&iofJ H:t t~k:e i~ H'tjn;.ites tO ¢-G~i~e,
`fr:-.·duct;r:g gathe:1rnJ, ~repsring. and sub.rrntting the e:::,r:":piete-d .spp~c.atlor: fon1) to the US.PTO. Tir,-,e•w:U v-~ry Cep<:r,di~i.g up!Jr, the k1mvid~ C:a~f:. µ,zly r,_.on1n~~t.:;. on
`the ~rr~~t oft~~ •:f(){; reqi.Jl~ ~-c-- comp:e.i.e thi~~ fom1 &ndfct sug~S'"Jc~ tor r~:.:c!ng ~:1.:~ ~rde~~ sho~~ 00 Si-.:':'-!""tt to- the .Ch~ef infonn:3t!on Off:~~,• U.S. P.otent ~.ct
`Tra¢erriaf!( Oftie(;!, U.S. Dep;;rtmem ,:~· Commer<>:. P.O, Box 'l4SO, .<\ielfandria, VA ~3·t3-·!4$0. 00 NOT S!2Ntl FE!::S OR COMPLETED FORMS TO :Hts
`AlX,r~tt;S, $ENO l'O: Commi,S$i(t~t' f{>t l"ll~t,S, f',0, Bo>t 1<18'0, Al<!!>'.,!ndl'i;s, VA .!l31:S·'l4cS~,
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`PTOiNA:26 (04-nl
`Ap:prwed fer t~,se th-rot.."9h 0:4f$C'-."'l013. OMS 005-f .... QOJ ~
`U.S. Y-zt!:l!'1t ~nti 'fn.=t:..~;-:-v$rk {}f~-~!'"...e:. U.S. !)E,:P.C..JXT~iE.NT ()F C·OMr .. ~ER.CE
`t.:nde:-~he Psp~:--'l,<1ork Red:..:ct;.i:;~ ;t',ct cl ·tB~5. M pe(i£.t-f::S 3te req~~red to re»~~1d le ij .;.{~Js--,.ct~-or-: cl infvnn~H!Y.: un!>s~s rt clispfr,)l:S ~ ''"~fo-:.: 0MB :x-:mr~ rt!)mber,
`TERMINAL DlSCLAIMER TO OBVIATE A DOUBLE PATENT~NG
`REJECTION OVER A "PRIOR" PATENT
`
`436t2-000201 5
`
`I f}oci;:N N~;ml,ei· (Opt:oria!)
`
`ni(c"1· t.,.'!ay 5, 2017
`
`Fr,w .Antagonist Antib-Odies Directed Against Calcitonin Geney Ra!ated Peptide and Methods Using s~une
`
`The app~cant Teva Phan·naceutlcals lntematlona!. GrnbH. owner of 10(} l)eff~ni ir:t~mst ;;, iris ir.<s!ant appl,~tion he-re;by dh,da!ms,
`e:>lc;spt ,s;, provK!e~ befow, fue termil,~l part oftt.e statua,;:y term of any patent g,anled on tr1e ;,,stam a,:,p!ivat:<m whid1 woukl extend beyon<!
`the explrsllml dare of the full stmutory lerm cf prior fmtei,t N'o. 9,365;64§ as tM terrn {)f s,;ir.j prk-.r pa~ent lS prfzsentty· stmitermcl by m1y
`terrnmal di;;c!almer. The applicant r:ete!))' a{l~e$ that any p•,'*mt -s-o gra;;ied on thlc' instant 1.3pp!ication st!atl t,.,;. anfort.~.ab-l<e- un!y 0, ~nd dming
`sur.n peiiod mat it and th.e j'.H'!Of patent em comm,1n!y owned. This agreement rum; \'.'lU1 any f>alimt granted t.>tl the ~m;tant applie,"3lion an-ct is
`bin<l::ng upon th.e tmmtN,. i!s suceflssors or assigns.
`
`!n mak,ng th,:s a!:xnle disdaimer, !~le ai;r.,t,r.an, coas not <iis<-.laim t.n!l terminal part of the terrn or any !,latent {}rnnte<:! an the in!.>iant application
`H~t would e:,:tand to UH? e>:piratkm date (;f ,he fuil staJut<1ry !.s-n-n of the prh,.r patl,mt, "as the teiw, of sale priQf ~lat!mt is presen~'y shortened by
`mw terminal ciesclaimei," in !he eveN !hat s.atd prior p.ster1t la~r:
`e>lpims fm taill:re io pay « mainteriance t~;
`rs t!;;!d unenfora;.,,:mtire;
`is found Envaiid bi;· a C(cid:144)Ufl of comr:.ment jun~l(:tiur,,
`is slatti!mily olsclaimect fo wtm§e or t.,,mir:a!!.y !:iisclaimed m,,_1er 37 CFR 1. 32. t:
`has. a§ claims cam;$.Bd by a mexamtnatk:.n c~rtif:cata;
`is r~;1.,zet.~d; or
`is in any manner lennina!ed prim to the .;;:;;,!ration uf I!$ full i;;,sb.itot:i term m, pr~s"'ntiy sr,0rtaned b;r a,iy terminal d,sclaime.-.
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`! her£by acl<:nt:>Wiati~e it1at any wfl!fu! false sta!1::ments. m;.,de ate punlstmbli, m1cter rn u.S.C. ,OU'1 l:l\.' t:r,e ,;ir im:prisomnen, ot not mon;;
`than f!v,;, (5} years .. or both,
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`,,,(cid:143)
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`lt. ~ f _____ _ TM tm~rsignect is ;;.r, alt91"ne¥ or .~iNrtt of re--~sf Reg. No.
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`O~vicd Koch
`~~!fOirR'~W---·--·-·
`
`Signah.:re
`
`Hermi:.irm Ru$$
`~~ing Officer
`
`WARMING; lnf(cid:144)fmat!on 1:tn this form may b&t.GfM puMlc, Cl't!cdit CMd !nf(nmatkm $fl'Ol!fd not
`b~ inc!ud~d on th\$ form, Pl'1:t¥id~ ers::-i:!it ,~.1rd lnform;stion ami author!3".at!on on f'TOA21ntt
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`Thi$ t-d!ectir;n cl k:f0:rHfmc>~~· $s re-f~t:hro t-.,< 37 CFR 1 :3-1.1._ -~ Ne :ntu!tl1~1.•>r1 i'$ r~~~S:re<t t-.::, ):-.,~t~n c; retat~ :a OOnef~ t<t the pui:ilk: \\(~<ti ls to 'fl~ {and by the·l.JSPTO
`to proc~S:s) an .spt,iic»iiu~). CQf}"!jd~•-n.?Jsht)' 12 qt}v~r~i(;,.~ by 35 U,S,C-. 1~~-: ~nd 3\> CFR 1 i1 ~N 1.1.-:t. Th!$ {'.;_~ectior:: ~s ~-i!mm~-d to t~ke 52 :"r:fr°M .. a~s tc o~r-:1µl~'fe,
`int".R:~n,,s gai~~'"lt':'6~ p<ep..:c:ti~?- ~t:d s.:.:Cmrtttng the com~h:1~00 ~p~ic~~~:cn1 !oJ:n t~ t:he USPTO. -r~rr~ ~<m ?...r~y dap<:tn!1!ng u~o.::-i th~ S~d!\.id!.;~t ;-_:~s-e, Any ccm9~nts en
`i.~ am-:tunJ of ~irr~ ~cu reqt~m ~c• -t-0mp~~$ th:s ft:•t:Y, ZiJ'ldl¢r suggesti•'j.tiS tor" :~d:~tin¥ t:;~!<: buf-da-.~: sh,;,.•\~«i ~ sx-:nt it1 tht~ Ghief !r.fr;rw>-"mon Ott:car, :J,S. Pate~~ and
`l!So<i,:,ma,l<; ()ftl~•\ \)S. (~t,;:,/'trr;l'!frt <:if Commere<e. P.O. B,x< '450, A!,s:<andri;,, V/:\ zz-::;n-Mso. ;::,o NOT SE~'O FEES CR COMPLETED FORMS TC n-os
`ADDRESS SEND TO: Cnmmissiom-<Y for .~atenhs, P.0" El¢): 1.4-SO, A~J(andri;s,. '<,'A 223.t3-1450.
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`PTO;Al}>/16 ;fl~-·:2,1
`.».ppR1,.,'<dtJ f:.if ~:$~;: ~h:'~~igh D:4{~('./.2013. -OMB 05:Si.-cD:Q.3--1
`t.LS. Pate~ ~f>~ T:r .. -7}tit-:n~k Offk:s~. U.S., fJE?.4J~Tt.1£NT OF Cot~i',.'1ERCE
`t:~r !..ha Pa_~.;,•<::rk Re<itKt:¢r: Act-~(f i 9&t:. no ~rsc;:s ere r~uu:~ m :-es~:,-,:c to a o-'J!~:on cl i:r-:rorr~1a6cn ~'!*S~l it_ i!s~,J~'.t'"s. ;3_ ,~fo:.i ot .. 18. c.ontrci :,Lln~=--
`TERMINAL rnscLAlMERTO OBVIATE A DOUBLE PATENTING
`REJECTION OVER A "PRIOR" PA TENT
`
`f !lao: May 5, 2017
`
`Fof: .Antagonist Antibodies Directed Against Ca!dtonin G~.me-- Related Peptide and Methods Usir1g Same
`Thr~ app!k~ant Teva Pharmacewtlca!s intema:tionatJimltl:J., zy,.-ner (,f 100 pemmt intere;;i in the insiant app!,ca!icn heretv ui:sc!aims,
`exG&f-"- a$ provide<:J oeimw, ihe tem1:nal part of !h~ statu!o;y tern~ of Bny parent granted on the mst,r;t appllcat,oa whk:h ;.,,-ou!d extend beyond
`the expiration rjate o! the fol; siatlltMY term of ~n~r p&Wf!1 No. ?,586,045 a,; ;ne terrn of said prior patQr,f ls prnsenUy stiwtened hy i3ny
`terminal d!$Ciaime:. The ar,p!,c;,nt hereby .agrees tt1ai any paient so ~rarilea on the lf',SSant app,lcation srmil be ,mforceable only for and d;.,;<in!:J
`sudi ~r;,Jd that it and the prior ~wnt are conu-nor,{y ~wned. Thi;; sgrr,ement mns wi!h any pa;ent wanted w1 the irisii3nt applic.3lron and i:,
`binding upon the granf~e; its. succ*SS'1rs- or ass~ns~
`
`ln ma~;tng the a~ve disc!a.irnef, the ampllamf doe& noi aisclalm t/)e terminal pait of ine term of any ;:,.ater.t gr$nted on the irn;Im1t a~-p!;cmkm
`trial would extend tD ine explr<,iion date of lhe fol! st.aa,smy term ,;it i11e prior ~.stent, ·'as tb.z !erm ,1f :s;;;irl prior pa~nt is pi'es~ntt-1 short».med by
`any wrmf:1al dl$c!aimer," in the e~.znl mat ~«lid prtl:)f p;gtent later:
`explfes fo, failure to~<>:,,' a rnaintensnre tee:
`is he!(! un~nrcrceab!E=:
`is found iiwa!kl by a r..ot.,"i of competent jurisdictton:
`is .statotoril)' disclaime~ ;n whole or tem1l.-:1aky <liscia,rnea under 37 CfR i ,321:
`rias al! ctalrns cam::eleo l:w a reexarnina!itm certttk-.ate;
`is rei$Sued: v;
`;s ln any 1nanner iermirm;ed prim to the expiratiofl of •!s 'i',iu statutory teim as p:resenUy shortened l':;',' ;;;ny terminai disclaimer;
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`I hereby ac:l<n:::sw,edge th;§l any wi!liui fa!se sta~ml:ir:ts rnmfo are purnshab!e w1der Hi U S.C. 100i by fine or im$)r:sonment of not more
`!nan fr,w {$} ysai~, or hot!'i.
`
`t, (cid:143)
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`The imdersignect is an attorney or ait~ni of rec•;:ir~l.
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`.t(zti~i,_,Jt~~✓l
`
`D~vld Kach
`MatM{Jtl;ffOffl?Jijf'.
`
`He_r-IDMn Russ
`MooagingO~
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