IN THE UNITED STATES PATENT ANO TRADEMARK OFFICE
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`! Examiner: LAU. Jonathan S
`! Group Art Unit 1623
`i Confirmation No.: 4251
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`i i Custom(-}f No.: 26263
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`Applic<.~1tion No.: 121737 ,283
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`Applicant: HELENEt( Mary Jane
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`Filed: May 25, 20'10
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`Titk~~: 30015730 .. ()053
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`Docket No.: Methods and Compositions
`for Adrninistrat!on of Iron
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`FIL.ED EtECTRONIC.Al-L Y VIA EfS .. WEB
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`Cormnissionftr for Patent~~
`P.O. Box ·1450
`Ak~xandria, VA 223·13 .. ·1450
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`I. Richard P, Lawrenco, d~clrn·o and state ns follows:
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`1. I <~H'n Din.~dor of F~~')S<:.'larch and Dev<-)klpment for LuHpokJ Ph~1nnNcouticnls, Inc.
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`2. I havo a B.S, De9ree/Fairlei9h Dickinson University, with a focus in
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`ChHt11i~•try.
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`f am ~1 narm3d inventor in the fol!owino US patt~nts:
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`7,n)4,702
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`M~~thods ~~nd Cornpositlons for AdminsitraUon of lmn
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`'7, 1 ()9,:369
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`Bioequivalenee tt.':iSt for iron"conkiinin9 formulations
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`6,911,342
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`Bio~~iquivalence tf~st for iron--containin9 forrnukltions
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`Pharmacosmos, Exh. 1025, p. 1
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`Application No. ·i:H787,283
`Declarnlkm of f.:.:ic1"1;:m1 P. LawrHncr~
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`LawnsnCt'1, "[)(~Vl~k.1prn1.~nt ;:,1nd Comparison of lmn Dextr:an
`Products," PDA )ournai of f)harmeict":Jt.n'icof ScifWCG· &
`Tfx~tmology, VoL 5~~, No. 5, Scpternbtlr--October 1 Oms, pp.
`·1 G10~·197 _
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`Trainino;
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`BS: Cl·11~rnislry/!\11athornatics, Fairk3iph D!ckinson Univernity,
`Madison, New ,h~t'SE!Y, Jun;;:.i ·1 fi79
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`Position~"> ;
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`Luitpold Pl·iarrnaceuticals, !nc. (Shirk~y. Nevv Y\xk)
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`04/03 .... Presc·mt
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`09/02 '" 04/0:3
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`Din.'1dor, Oua!ity Assurance
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`0Eii02 --- 09i02
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`Director, Oua!ity Control
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`·1 Ol79 ···- 03/83
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`3. i am a narned inventor of the subjeGl rnaHf~r r.::lairned in pres~~int U.S. P;,~1tt:~nt
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`/\ppiication 12/lff7,2H:3 (the ;,•;zg3 appliG<:)tion"), entit!<~d "MHthods and Compositions for
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`Adrninistmtion of Iron", filed on May 2~;, 20'!0 .
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`.(L Based on rny oxporionco, an iron polyisomaltos~~ is H tyw~ or iron
`carbohydrak~ complex that induch:~~;; ison1a!to~~l'9 units in th~'9 carbo!iydrate eornponent
`An isorr1;:,)!t0Sf..'.) is~'' c:H~wccharide slrntlarto tTi<:iltoso, t)ut wiH-1 a a--(1--G)--linkaqe bet'W(~en
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`two 9lucosf.:, units insk'1ad of an o"fl-·4Hlnkane. Onf.:1 ex.:,1mpk-: of an iron polyi~'>O!l1alt.om')
`····.-·11")['1· '')l'.t 1''l'·1t· 1'·::.;
`r'.-)f'f)r~l•:>x· '(' ·-~"' t'f('H·' ;,.,,.)>"i'''·'!l!.,...,"'l."4"'' 1· ~' ,.,
`1>.,1()t"()f'·'/i\ 'Mj··i~'!'"' ti·1<• l''~',,.l)'»~)\•tj<'::•t•.,,,
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`a pure linear chi:.:HTlka! strudum of repe<Jt.in~,1 ai-6 Hnk~'9d 9tucos(~ units. In contrm1t, •~'
`dextran is a branch('9d uluc;.,u-1 with straiqt1t chaim~ havino ol·G g!ycosidic !inka9eH and
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`Pharmacosmos, Exh. 1025, p. 2
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`J.\pplic<oltion No. ·1211m .~~B~)
`D~~dr,irdion of Fici·1ard P Lawrencl'.!
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`br;:·:mches b~~oinnin9 fron) cr1<) linl~n9es, P1·1ysi0Ghernica! properlk·;~> of lhn lron
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`101308 it was known that lsornaito~>t~ o!i9orr1(~ir~; pmv~snt or· b!och: anaphy!axis <:-)nd that
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`later rosearch in the 1 !-:Y70s and ·i DUO~> ~>howod that isornaltr1so oliqorners aGted m:;
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`ha pt.ens a~~F*1~>t drn.datln9 anti--d~~xtran antibodh.~s (~m91~~ 469, col. i, In. S3--EiH, il~:I). F\:H ..
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`,foihn et riL and consist{ml: 1,vith tht'~ understandinn in thB art at !h~~i lirne of tl!inq, a haptl~n
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`can bind an antibody \Nithout inducino anaphylaxis or an immune re:-.>ponse (s~~f~ paoe
`t\c'''l)r·,.-<1'1·"'1 t') f,,,h,··i '''l ·:•!
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`·1,eoo tno dornm1t;:,1I iron) of the the iron isonmltoslde Monofi:jr'''' (i.e., (:if)(:l exan1p!o of <~n
`iron poly!sornalti:.>so) aris~~s from nxlucic~d imrnuno~wnic potential and Db~)E:mG<-) o!'
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`t~-j \,~·~.'!~I~.,,, ~~ ... ,
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`7. Claim ·1 of the '283 application rf-:;dl.e~>, inter <Jlia. ''wh<~roin tho iron
`carbohycJr<:~h::; compk~:i< l'K1S n substantially nein .. irnrnunonenlc carbohydrate component".
`!)'"-~"'".i'-'" ''-''l;(J'~'f' .. "" •i··~"'t ti·'•" ,, . .,.,r·1 i.<-'('\r1··1 ~'i"')'"l.d•" ~· 1l''l1"r"f'"···~''
`1• ''' f''~'.' t)•~1·r··11'1.·v·' ~-.,,~t J·~hr·i "'·I ·;.!
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`e. C!ahn 3 of th(~ '2B3 appfo .. -:afam n:idtf..'lS "whor(.~in the iron cart)ohydralo c.orriplo;<
`has substantially no cmnr> reactivity with anli-·dextrnn antibo\fa-;s". B~~S('Jd on my
`experh:..::nc~'l, cross .. reactivi!y at u·10 tinWJ of fiHn9 was lmderstood .;:m a reaction bol:vveon
`an antibody and ~m anti£ien (that di'ffHrs frorn ;::in irnmunoqen) n~sultino in an imrnurw~
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`response. !n other words, rnere bind!nn of an antibody Hnd an anti9on wng not
`un<:k~rstood ns "cross .. reactivity" in thc-~ absence of an imrnurn.~ rt'}spons(~ . It is rny opinl<:m
`that Jahn et aL provides evidence that the iron isornaltoside Monofor'~'' (i.e .. , one exanip!e
`of <:~n iron polyisornaito~~1~)) h.as sub~~t:antially no crof>s ronctiv!ty 1Nith <::lntHki:xtrHn
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`Pharmacosmos, Exh. 1025, p. 3
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`Apr)licntinn No. ·121787, W~~
`D~~d<:trz~tlon of Richard P. Lavvrnnct~
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`antibodi~~s, L~'i. 1 MonoferM does not. efh:;d ,~l substantial immune nlsponsf1 and there ls
`substanlfa":JUy no doxtrarHnduced anaphalylic ff~~;ictions,
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`l hereby dodare that tt1e statemc:mts made of my own knowledqt-~ are l.ru~'.l <:·rn<J
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`lhat al! swtenwlnts rnado on information mado on belief art1 bdieved to be true.
`acknowledg.e that willful false statf~rtfonts and alike (:m.~ punish~lble by flnt'i or
`irnprisonnwmt or both ("18 U.S,C, § 10o·n and may _!E)oparc1i:w thfi validity ofthe
`<:ipplieation or any patent h:.>i5uin9 th(~rc:3on.
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`Pharmacosmos, Exh. 1025, p. 4