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`IN THE UNITE!) STATES PATENT
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`GFFICE‘
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`Patgnme;
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`Ya:ng at al.
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`USS. 35,897,081}
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`September- 16? 2612
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`March 13,, 2813
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`11W44~80023
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`Mai} ‘Smp Int-er Farms: Raexam
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`15.3,. Patem and Tiademarkflffice
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`Certficate afEFS Web Tratzsrxzissian
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`i’keréby 363??ny {km firis aarrespmdeme is being.
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`imnsmified via the {£81. Pawn! and fi‘adeimxk
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`Michaei ‘1; wakcms: . a KMicfzaei I
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`BECLARAT’IQN OF B. ARLEE ROGUE,
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`UNDER 37
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`§ 1.132
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`Madama:
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`I, 13; Arm- Vli’sraguzej 1311.3, ck; hereby make: the; feltuwing declaration:
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`TecimitaalBaak
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`fiaid 0f pharmacmfieat dwelopmeng and particuiarliy oral {Engage
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`devempmenti far 22' years. I am ainployed by: MomSoi
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`“MemS-ol")3 me. assignea afissued patani
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`for Manufacturing Stfiaiagy and? Innovation.
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`Ihavaa Sin Physical Chginisn‘y ‘fi‘ojm Calaradfl State Uifiversity and a,P}1.E. in Chemical and
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`BiQEngin‘earing fmm
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`Biachemica] Engmeafing atitha Umfiiversity fif‘Vigginia. Ewing my smear, I have been. nammi as
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`an inventm‘ an cvea‘ US. patams am numeroug foreign patants directed ta the foimulatifin,
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`pmmssing andfar packaging (if pharmacautiaal 011a} disintegratin maximums ("tabla-ts
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`swim)? 'I have. iiireet fixpéarience with film mmmemiai
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`sis-arms as wail as
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`testing the: same.
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`1319663535113 “fphamaflgmim film
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`'Iihave read 1:11;; 'IGSIH Patent and the flffi Cis Acfian iSsuaéf {In Navemhef 295-2812 in the" Ffigxfimififlfifln
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`of the: ‘flfifi Pam: 'i’Office Action”) and the refemnees sited therein, and. 1 haw 3130' Kffi‘é’ifiwed- 1316
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`to the indapemdem Glaims set-{faith in Patentee‘s Rspfiy t0 the (1*ffiieaActiaén
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`enncmmndy fi!eé”hemwzith,.
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`am‘andment
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`II.
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`Prnducin marking fitms in :acczm'dance with the "$33 Patent
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`Each 0;? the "’33 iats afresulting filing. (L015 1-?3}:wntaining appmximateiy 2,909,800 individuai
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`ii} for Gamma-rem! use: and mgul‘atgry
`dosagg units par 10’: discussed harem weremafiufactm‘ad:
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`appmvatg {iii} 'inwmpiianw with:
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`regulatiansj inalufiing thcsereiming toanaiytigai Chemisait testing far variatian in anti’vav in. individua}
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`desage units; and {iii} in. acsemt'diame with they iinvaznt-imn dist: 1:03am}. in $164089 Patient, and as; claimad
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`the ‘0 89 Patent; bath. as .i'ssuad and as amended {in ‘thzePatflntefi-k Repiy if; 1125;: Offiw Astian; by:
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`{a} farming axfiowabieipaléymer matrix camprismg a water-smiuble paiymer, a when: and a:
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`matrix hwing asubmamiafléy unifiarm- digitributifln ofsaid. active;
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`phmmacgeutiaal astive,
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`(b1) Wasting: said leWabIe: pfiiymer matrix,
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`viscfisity flan}. about
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`flo-wahie pa‘iymermanix haying a
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`thmugh a pram-:33. mmprising cutawayng saici pniymermatrix
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`thmugh adrying appazmus and evapemting at least :a. partial“: of said 361th in farm 2; W330»
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`having said active subsmntiailiy 1y disti‘ihuted fmughnusts within ,abaut the
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`513i: 4 minutas hydrapicfly 'incrfiafsing the Vis‘fliflsity Gfsaifi paiymex matrix 11130161 initiation 9f
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`drying. ta maintaifi saié substantially ‘unifm-‘m disstrihufizun of‘said .actizvefby baking—in or
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`subsfamialiy pmveufing migrafimwf said acfive within said. viscxahsiagfizc film Whemin the
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`.pelymer matrix temperature is: 108‘ 9EC 03F {353;
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`visefireiastic filmlwhfirein said
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`waiting ghamaaeezutica} film 3121.31.35: waiar saws-rat
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`disffihutien 0f aative: by said laekingéin 0:17 substantially prewntingmigratian {if said. amine is
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`mainiainedfinsh that: unifemity fireman:- in' the amount affine Iactiva
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`sizecl individual dflssaga units, sampleii from different locations cf resuifing pharmafieufigal
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`film, varies by {m mere,- than 19%.; and
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`{‘65) pfix'ifemling analytica} chemical taséts for wifiamaity ofccxntent of said aative Sin.
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`substamially equal sized, individual dazaaga units of said. sampled faulting pharmaeaufical film,
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`said tests, indiaafiiug that uniformity of Gamers? in tha amounmf the active: varies by m mare than
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`[$63 Appenéix A} Said'IESLILfiHg phaflnaqemiaal film suitable foiz"cammemial and
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`regulamry approval, Whgmin said raigmatoty appmval is pfavidefi by this
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`Adfiitionalliys the uniformiiy 0f mutant. fits-31111911111: ofamive: as sampled fmm the 7‘3 101s of
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`making fiim. Writs 119 mm than 136% frsm'the desired amount, 0fthe active as indicated by
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`said aflaiytiwl {331621131631 feasts fffim 4‘23} abuva. [See Appendix B]
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`Anal. 13921,]. asiin .,fmiflniiblfimiy,,Qf'CQntfimfifl’atsnteefs Resulting :; Filmg;
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`demonstrate the unifmmity of individual diisagfi unit fiims, I campijlcd individual dasagfit unit
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`data fm'f individual Lats Ii ’33: all Elf whiqh ware. éififiiasefl in .MQnflSfll‘s
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`Prcixduat Review to the
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`7?. Ten (16) individuai dang units all having the :Same- dimemims were cut {but fi‘emdiffercm
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`ififlafifilm Qf-wgh 9f the: 3’3 Eats af‘rasuiti-ng E11113 using a csaimnamia} Vpaakaging machine, thus
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`provifiing 173G Tandem}? sampled infiifiduat d‘asagevunits, fan each 13an the
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`sampiafi ware analyzed by 1%: Validated .Inefiiad, in mmpfianc‘e With FDA guidefinas and.
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`regulatin Vx'ragarding samg:
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`was extractad and: analyzfisd by High Perfommnce Liquid Chmmatagraghy (HFLC) againsi an
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`enema} standard tie; quantify the ammmt 01?“ active. prawn: in flash individual cimage unit.
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`Accerdinig m the invantive pmmss set {firth and claimed in the 1385:} Patent, and in amortiance
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`with FDA namemiatm‘eg I have prepmfed tables ShGWfl 2:5 Appexrxdifisas A, B and C, reflaefing the
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`wife-unity Qif Wflfrfiflt 0f aetive of individual dusags units within particular Iota: and amass
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`First, tilt}; unifm‘miiy {if 90111231101? activa in a {at is determian Ih‘mugh estflbiishing the; amount 0f
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`active {Aug}; actually presantrin Bafih sampied individual desagya unit fmim. thesame law) as
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`fictermincd. by taking the difim‘enee hatween the: amasth afaetive inthe' 3amp1awith the mag:
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`aefive (Max-WW) minus the amaunt of actiwv in the sample with the least. amaum aflacféivue
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`(#4311371134ng and dividing the: differenca by {he awxiaga amount if acme in the.”le samples (140th
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`Sample Awerage). That. is: CMamem » Min-1mm) f ( {Amm Ami.“ + .Ammfifl The results
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`in Appendix
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`Semnd, the unaiifmim £131 £3312” Czentent flGFQSS diffemnt 30:3 is'dateflninied fhi‘angfh estabfishihg the
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`amaunt flf‘active actualiy prewar in emf: sampled individua} (image unit from a}; 73 1013 am:
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`comparingthat amfiumtflf active with a"‘ta1:gsz’* 0r “zdes-irad“ 211110th (If active, camaineé therein.
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`T1316: target 3111c;th 9f' v'c.1c:f£ibv£2a Wham iris a pharmaeeutiiaai, is areiérmd was
`“Label Claim“, ihus
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`identifing tin:- amcsunt ufpharmaesutiflal active in the film 1:0 amen; The: dasimd amaum
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`186% of the target; amaum; Each individual dasage unit film cut .f-mm any individual fat must
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`have the»; dgsimd 003$th 01“ phamaawtiaai active, varying
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`dagir'ed amgunt; Sets: Appendix
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`@830 Patent i’mcasslmdmss.Fflms. Whit}:
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`mired Unifmmift ofCantanf 0f
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`Th€r~ res-111m Shawn in ‘tha appendices astahfifih that tin: regulfing: fiims produced by the inventive
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`metth {If' 31%: "03830 Patent-as tfiSClfi’sfiz} am} claian haw. the-‘imuired unifermity Of content based
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`(in. anaiyfiflg? chemica} testing; Fitsg 1116 fimmmt cf azfi'v-te varies
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`daaagfi units. :sampikad fmma ‘partjiaular 1m ofrasuhifiggfilm
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`'S-ewniia.'an10unt of activa- amass difimznt his Bf wwlfingfilm variesna mare {ham {8% fmm
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`the desired zmfium 0“? 11m acfive,. See. Appendix 33. Finally, the uniformity 3f mn’tent of the 723
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`101$ Qf'regsulting film mflet‘s iWEfinanre‘Sifingfint standards; fm‘ exampia, the flaw shaws; (i) '46
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`lots Qflffisuifing film wherein maunifmmity (If cant-en: of active is Shawn with the amen-nit 0f
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`actim varying: by less than 5%;
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`active is Shaw-n: with the amount efaetive varying 15:33,: Bess than, 4%; 4 1m of remitng film
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`than 3%.; and 1 East Gf'msuiting
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`1 harem? deciam margin statements made harem of my own hawkeng are true: and that
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`31} 81332611131113 made an infcxrmafifln and befietf are. ‘bsiieved ta: be true; and fizfihar that {base
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`staiements were made with thakmwlisdgfi that @1113)! féise: Statements and the 13m- s‘a maria are
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`punishabie by fihe or imprisanmem, or 50th, 'undmf Sgctieun 11301 ufT‘itla 1:8 0f the United Stags
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`Eadie, andf that such statements. may jéfiflpafd‘ififi the vafidfiity afthaappliwtifin arva 'pai‘gnts
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`issued {harem}.
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`Dated this 13th day oifMamh, X313
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`x
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`Arlie Bague
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`Page 5
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`{Max—Min)ILatSammieAverage
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`1.01%.0 r
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`Page 7
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`Eats. $933.19 W53
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`APPENDIX C.
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`7
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`V
`Lat-iesshan
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`7% D'iiffesrenue
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`Page 8
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`(cid:9)
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`CERTIFICATE OF FIRST CLASS SERVICE
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`It is certified that a copy of this DECLARATION OF B. ARLIE BOGUE, PH.D.
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`UNDER 37 C.F.R. § 1.132 has been served, by first class mail, on March 13, 2013, in its
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`entirety on the third party requester as provided in 37 CFR § 1.903 and 37 CFR § 1.248 at the
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`addess below.
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`DANIELLE L. HERRITT
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`McCARTER & ENGLISH LLP
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`265 FRANKLIN STREET
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`BOSTON, MASSACHUSETTS 02110
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`/Daniel A. Scola Jr./
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`Daniel A. Scola, Jr.
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`Registration No.: 29,855
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`Attorney for the Patentee
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`Page 9
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`Page 9
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