SEP—23-1998
`
`12:45
`
`_- PEG HC PRTENT DIU.
`
`_
`
`513 622 33% P.B3/1'5
`
`
`
`llhvifihficn-hhlh-Ihhu .'
`n “uni—fink. Mull
`«fig——
`
`SEP 2 3 i998
`
`GHOUP 1600
`INTHEUNITEDSTATESPATENTANDTRADEMARKOFFICE
`:fl
`
`Case 67111!
`
`:
`In the Application of
`I ‘
`:
`PAUL ALBERT SAGEL, ET AL.
`Group A“ Unit 1614
`;
`Serial No. o9/o4o,ooo
`,
`»
`Examiner 5. Rose
`:
`mum 17, 1993
`For ADELIVERY SYSTEMpom-mommausmoAsm‘m or
`MATERIAL HAVING LOWHm smmsss
`
`flag;
`_
`#77“ 6/
`W/q’
`
`I
`
`:
`
`g
`
`3
`
`Assistant Commiisioner for Pm
`
`Washington. no. 20231
`
`mm
`
`Inmponsemtho Ofio'erdondaIdMay‘l, 1998, thefimetor'eepondbclngmdedhym
`
`months. plus: reconsider the above-idmfifi'al applieutioa in view of the following maximal: and
`remark. A Terminal Disclaimer and lnfomm'on Disclosure Statement also included
`
`,
`Plume delete Gym 12
`Plus: amend Claims' 1 and 20 n'foilm:
`
`:-
`i e
`1. (Arnended) A delivery system for delivering a tooth wiiilening substance to' fro r
`Plunlity of adiaunt lathWWW
`
`Wm. slid delivery syrm comprising:
`a.
`a strip of flexible marerial having a sufficient flexibility to form a curved shape on a
`
`‘
`
`plurality of adjammr teeth. said strip of material being readily conformable to tooth
`surface: and to intersfitial
`tooth spaces without permanent defamation when said
`delivery system is planar! thereaguinst; and
`
`b. a moth Whitening submniz applied to said suifi‘of material such um when said
`delivery oystem-is placed on a surface of raid man; said rum comets said surface '
`providing In naive onto said surface. arid substance also providing adhe'nive
`
`!
`
`($2 I
`
`
`
`ice/za/ss WED 12:4‘8 [TX/RX N0 9752] I003
`
`6
`
`CLIO USA
`EXHIBIT 1012
`PAGE 000001
`
`
`PAGE 000001
`
`CLIO USA
`
`EXHIBIT 1012
`
`

`

`SEP—23—1998
`
`12:45
`
`“\Pac HC PRTENT DIU.
`
`_
`
`513 62 33cm
`
`F.04/15
`
`1
`
`.
`
`fi '”J"
`
`'-
`
`attachment betweensaid,strip ofmaterial and said curtain: to hold said delivery system
`
`in place for a Sufficient time to allow said active to act upon said surface.
`
`i1 }((Amandcd) A method of-delivering a tooth whitening substance to mm a plurality of
`adjacent teeth. said method comprising the steps of:
`I
`a.
`applying said substaticc onto a conformable strip of material having a sufficient
`flexibility to form a curved shape around a plurality of adjacent teeth and said strip of
`
`_
`i
`'
`
`.
`
`% 74
`
`,
`
`l
`
`3
`
`material being readily conformable to tooth urine: and to interstitial tooth spaces
`without permanent defamation; and
`.
`
`b. applyingsaidconformablestripofmaterialWithsaidsubstahce‘thereontosaidplurality
`
`of adjacent teeth without permanent deformation of said strip of material such that said
`
`substance contacts said surface. said substance providing an active onto said plurality
`of adjacent rah, said substance also providing adhulve attachment between said strip
`of material and said plurality of adjacent teeth to hold said delivery system in place for
`a sufficient time to allow said active to act upon said surface.
`
`l
`i
`I
`
`/ I
`l
`Plaso insert the following new Claims:
`
`.
`
`CLO/Hf
`
`A delivery system for delivering a tooth whitening substance to a plurality of adjacent
`teeth. said delivery system comprising:
`.
`'a.
`a strip of flexible material having a suificient flexibility to form a curved shape on a
`plurality of adjacent teeth, said strip of material being readily confonnablc to tooth
`
`surfaces and to interstitial tooth spans Wilhmtt permanent deformation when said
`
`delivery system is placed rhemgainst and said strip of material containing 'an array of
`shallow pockets: and
`'
`
`b. a tooth whitening substance applied to said strip of material such that when said -
`delivery system is placed on a surface of-said teeth. said substance contacts said surface
`providing an active onto said surface. said substance also providing adhmivc
`attachment between said strip ofmaterial and said surface to hold said delivery system
`inplace forasuffieienttirneto allowsaid activeto aetupon said surfaer.
`
`..
`
`.
`
`5,)!
`26.
`
`A deiivet? systun for delivering 1W whitening substance to a plurality of adjacent
`teeth. said delivery system comprising:
`.
`a. a strip of flexible material having a sufficient disability to form a curved shape on a
`plurality of adjacent teak, said strip of material being mdily conformable to tooth
`
`(9%
`
`09/23/98 WED 12:46
`
`69
`
`[TX/RX N0 97521-004
`
`PAGE 000002
`
`PAGE 000002
`
`

`

`SEP-23-1998
`
`12:46
`
`>
`
`P&G HC PRTENT DIU.
`
`513 622 3302
`
`RES/15
`
`3
`
`tooth spaces without permanent deformation when said
`surfaces and no interstitial
`delivery system is placed thereagainst:
`'
`
`la.
`
`a tooth whitening substance applied to said strip of material such that when said
`
`delivery system is placed on a surface of said teeth, said substance contacts sald susface
`
`i
`
`said substance also providing adhesive
`providing an active onto said surface.
`attachment between said strip of material and said stufabc to hold said delivery system
`in place for a sufficlent time to allots! said active to act upon said surface: and
`a release liner.
`
`c.
`
`9/
`
`3 ”33
`
`§{ A delivery system for dellvering a tooth whitening substance to a plurality of-adjacent
`
`‘
`
`.
`
`V teeth, said delivery system comprising:
`_
`.
`a. a strip of-tlexible damn made of polyethylene; and
`b. a tooth. Whitening substance applied to said strip of material such that when said
`delivery system is placed on a surface of said teeth, said substance contacts said surface
`
`‘
`
`providing an active onto said stnface. said substance also providing adhesive
`attachment between said strip of material and said surface to held said delivery system
`in place for a sufficient time In allow said active to act upon said. surface.
`
`
`
`.
`
`' BEMAEKS
`
`Claims 1-11 and 13-23 tannin pleading in this appliance Antecedent language for the
`amendmenthlaims l aed'zoieseuedeepagea.lime37udpeges, lieee la-zl. Asshowninlhe
`figures,thesn-ipofrnaterial my'alsobc_aflachedmthebnd<sideoftheteethntaddifiontothefiont
`side. Antecedent languagefortheothersmendlne’ntmadetoClaim l maybehundanpage 4, fins 13-
`14. The language “substantially n'ansp'asmt and almost unnndeenble when worn" includes when the
`delivery system is the color of the leaner adieu the delivery system iii-substantially u-anslucerlt.‘
`Antecedent languagcforthealrayofshallowpwketsis foundonpage 8, lines 3-11. Anal-ray of
`shadowpockes'eeeompasssofdeeeripdonnlaningmorelhanenepoeket. Antecedentlzuguagefor
`the release liner in Claim 22 is found seepage-l2, lines 33-37-and on page 13. lines lo-ll. Antecedent
`language for polyethylenein Claim 23 isi'ollnd onpage 7, lines 19 and 21-22.
`
`The Exantirulrhas' tejcted Claims l-20 as being unpatesmable over Sehiraldi and Hand. Ame
`etal., Metals, orEngelbertetal., takrallvith Cultisetal. anduyeneofNewmanctaL. Gold-stein at
`al. or McLaughlin et al., and in further view of Warren and Eismhut. This rejection is respectfully
`traversed.
`'
`
`Schilaldidisclosesanesn'udedfilmincorponfingamedim. Therefimeedoeenotmeh
`orsuggmasubshneebrwhiteningtheteflhesrequiredinparth)ofthein¢pemlentelaims.l
`Selliraldi only discloses ntcdiummtsand den not disclose anytype ofmetl: whining substances;
`
`
`
`"559nm“; .llED 12:46
`
`[TX/Rx NO 97521- @005
`
`6‘9
`
`
`
`PAGE 000003
`
`PAGE 000003
`
`

`

`
`
`SEP-23-1998
`
`12:46
`
`P85 HC PRTENT DIU.
`
`_\
`
`_
`
`513 622 3308
`
`RES/15
`
`“Schiraldidiselomthatthefilmmusthehydratedtoheflexihlewhiehdounotmeettheflaihilityas
`required in past (a) afthe indeputdmt claims. Additionally, Schiraldl does'nottmch or 31153th the
`ddivewsysmusdforwhitmingmybemhshafifllymmadalmstmudeahiewhm
`worn,-m’mmmmnmmyotmwwmummeaummmm
`whiteningmayincludeateleaseliner. Onehavingordinatyskillintheartwnldnothavebeen
`
`motivatedhythedkdmmehiSchhalditndevelopeddiepmmflydaimeddeflvuysymfm
`delivei'iiigalnothwhiteningsuhmnee.
`-
`Hanoi,Manual,Moiais.andEngleheiteachdi§cloSemmtialsthatmayheusedintheoml
`cavity. Hanel disclaim aniaifieulasiun or occlusion material which is used to determine inmfetmcos
`
`and contactsinthemouth. Thismaurialccnfiinsa'dy'e. Hanclonlydisclosutheuseofflwmtflisl
`
`fordeteminmginwrfnuteesandcomaminthcmomhbyhafingapusonhkcdownon‘fl'iematerial
`iwiihthefips oftheteeth foreshoi'ipeiiodofiime. maintained also discloses a method for
`cvaluafinghitechanflerisfiumdaldngimprssiouofthcmh. Moraisdiselcsesadenlalmodel
`articulate: having a strip of flexible material as part of the atticulator. Englebcrt. et al. discloses
`improved nonwoveu fabrie which may he used to: personal ear: or health are products such as
`sanitaiy napkins. diapers,
`ineonfinenae gamma. scrubbing devious, ballasts, and washclothes.
`Time referenca are in eontrast to the present invention wherein the claimed delivery system
`adheres to a plurality of teeth for a sufficient time for the naive to act upon the teeth surface.
`Theelaimeddeliveiysysuncoinaimanadhesiveandmymainonfliesurfaeesoftheteethfiera
`suflieieitiengihoftime. Additionally.fliecitedwfitmcadonotmchot suggestathatflicmamial
`
`oomainasubstaneefarwhitaingdietathasMuirdinpaitth)oftheindepa1dentclaims. Thedted
`references do not teach or suggest that the delivery system used for whitening may be substantially
`tianspamit and almost unnotieable when worn. that the material may contain an array of shallow
`pockets. orthatthedeliwryqstuntuedfotwhimingmyincludeareleaseliner. Therefore. one
`having ordinaiy skill in the an would not have hem motivated by the disclosure in Hanel, Arcan et al,
`Morais, or Englebett ta‘develop the pitsciit invatfioii.
`
`Curtis et a1. dieeiosa an eieefie putty-like matsrialtha: is radii)! moldahle and may be shaped
`andp‘rssedagalnsuhetathandgiimsurfieu.Thematetialisstrongaoughtoflifidtesumfissuc
`away from the tooth to expose the giny'val surface”. (colinnn 3, lines 12-14) Additionally, the material
`will haye suficient rebound admittance [in slump] total-lain inplaee and to retain its shape when
`molded. (column3,linesaB-40) TheiiiateiialsdmribdbyCuifisetal.m“tahemoldedandshaped
`while being suficimtlyenhereutm heha'ridled as am". (column 4. Esau-46) This is incanttast
`tothepminvu'ifionwheretheflmhlemfialis unfotnahletntoothsutfaeesaadspucsandis
`not
`liefmanently deformable. as claimed in part. (a) of the Wanda: claims. The dental.
`mmpositiondmerihu‘linCurtisetal. isheldngaivsttheteethhytheptoperfies ofthepuny—lilte
`material. CmmariltheflexihleMiialafdtcpruuitimenfion ishddonfliesiufimoftheteeth by
`the tooth whitening substanee which provides the adhesive attachinent henna the material and
`tooth surface. Without a tooth whitening suhmnee. the material of the present invention would not:
`
`63
`
`09/23/98 WED 12:46
`
`[TX/RX NO 9752']
`
`.006
`
`
`PAGE 000004
`
`
`PAGE 000004
`
`

`

`SEP-23-1998
`
`12346
`
`_: P&G HC PRTENT DIU.
`
`"n
`
`513 622 3300
`
`P.67/15
`
`"attachtothauah. Addiiionally, Curtis 3:]. dosnuitanhorsuggutthntthndcliverysym or
`' mrial may be substantially unspmt and almofi unnoticcabic when warn. that the material may
`conuinanamyofshailowpoclzas orthatflmdnfivuysymmormfialmyincludcamlmsciim.
`'mmuhsmmdmpolyanylmmudsclosamcwaal (calms, lin: l4)
`Howcverfihepolyahylmewnxisdiscloseduamdiablcnnmrialtoaapsulammanmandismt
`disclosed as a mum: minis] for the puny-line inninxial. Wiihnut hindsight reconstruction, one
`havingordinarysldllin'flwmmuldngthavabemmufiwlbdtodfldnplhcpminvemicnbasedon
`til: discloses ofCurfisaal.
`I
`
`nnuidauamnabyumanionidminninmndmuuguinanl.“cumin:
`traditional dcuinl my and blanhinggiuzhainnybqnsndinuun-ays. Nonnnfmnnniclns teach or
`
`‘wggentheuseofnflaiblemmialthnkmtpmapaflydcfomlable. Thadescfibedmysue
`anuhcdtbapmm'amhbythdsnugfitflnuayhmidu. Onehnvingordinmskfllinthemwonld
`mhawbunmfimtslbdbvdopdnpminvmficnbadmthediscloaaochwmaal.,'
`Goldstunetal. anndLIughlmetal.
`
`Wmdisclosesathinfiimmfilbawnaithcteethandddiverfluofidb.
`
`'I'hcrcfcmncedos
`
`winchorsuggst-asubmacfnrwhitmifigthctflhasmquimiinpanm)ofthcindcpcudmt
`claims. Wmdisclnm-ihamefihnisnnlyminfiimmumudm:«aluminum
`oflhcu‘cth. Additionally, Warrendbesnotmho‘r suggstthanh: deliverysyslmiusei for Winning
`maybesubsunfinuynmpmandahnonmfiabbwhmwomthnthcmmiaimaymminm
`my ofshailaw pockets. or uni the delivery symm used for whining may include a mime lin‘cr.
`onchnvingordinniyninuinlhnmwnuldmhnvnbanmivmdbymcdis'clnsminWmmm
`dcveiopdtheprcscufly claimed thlivexysystcrnfot deiivexingatnothwhitming substance.
`
`_
`
`AmPslaJim ofthg Eisnhut punt disclmaholding ship for filling materiaL The only use
`'disclnsdinEkmhutisfoxthefiflil‘lgofmh. Thimiemisinennmiomcpmni‘invmian
`‘ whcmhunchhnaddgfiwlysymisfordcfivcfingamrhwhhwingsubmme. Eisenhutdosnet
`whorsuggma substance rnrwhizailngihemifis requiradiapan (blame independm claim.-
`Additionally. The-cirdnfernwdoumttnchor suggnsiihniilnadiverysysinmnindfinwhiming
`maybe substandallyuansparmuhdahnost unnafiaablc when Womdmthemawrial mayccmzinan
`
`may ot‘shallaw pedals, orxhal thcdcliva'ly imam used foi- whining may incind: “clans: liner.
`TthxaminerhasmdthazTiguRZiEnS'upoékfl-iikz”. Fromthcu'anshtionitisshcwnthat
`i'iansinuiennddlnpnnoruiem-ipinwhichunmlhgmmdalmmkamlyMam.
`EmifiianSwaspukfi-lflc.flfisbdisfingliishdfimnthepmhvcnfimwhichmycomaina-
`
`shallowmyofpocketsmauimplyunniamupockst monetizvingordilwysldliinfilean
`wouldnot havehumotivaxdbythcdiscidsuiainEisdlhutmdevdoplhcpmunhvmfian.
`
`In an intendewwiththe Examiner, th: Emfimralso chdtwu’rsmga a]. 11319113654058!
`111435321132). Tsmgclaidisciascinsustainad-mlas: "mixfordmxalappliafiun which contains
`wand-microbial agmoramlonmflmrisralfiudwhnthnmuixcnmm. Tsalgetal.
`mammals matrix ispaltofal: oral brush. Tleng :taL-dau not land: or suggest flat tl'iis
`
`ED
`
`09/23/98 WED 12:46
`
`[TX/Rx No 975211007
`
`
`
`PAGE 000005
`
`PAGE 000005
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`

`

`
`
`SEP-23-1998
`
`1214'?
`
`11>F'8.G HC PRTENT DIU.
`
`-'\
`
`513 E22 3338
`
`REE/15
`
`' matrix could be applied to the teed: surf-m I: required by the claimed inmtion. Additionally.
`Tungoul. dounottanhorwggmuytypcofmbmafiwrwhmningthzuflnumuhdhpan
`(b)officind¢p'=ndmtclsims. Tn'e'ngetal. dodinotuchorsuggmtlnnhoddivaysyfleinusodfor
`Whitminguuyqubmfianyuammnndalmonunnofimble whalwom asthemanixmynot
`mbewomhyapemthatthemuulalmycominmmyofshaflowpocken. cor-thank:
`dofivuysyflmusdfcrwhhningmyincludeaxflaso-Iimr. Onohavingordinalysldllinihem
`
`would nothnvcbccnmafivamihyilhsdisclminTsmgctnl. todcvclopoddicpmmtlyclahnad
`delivery systnn for dclivcring a m whining substance,
`
`.
`Wang '
`Inmeimemewwimmenumim. meEx'ammezhusmddummeclauns maybe rejected
`under the judicially created doctxine of obvioumess—type doublo patenting a being unpatantable
`over copcndiug application Serial No. 08/870,330 which was filed on June 6. 1997. Attached to
`
`this mpome is a Temfinal Disclaimer our application Serial No. 08/870,330.
`
`QOEQLQSIOE
`
`Applicants have and: an artist efi'ott to distinguish the claimed invanfion flora the applied
`document. Rmnsldumiun of this application in vial! of the madman, remarks, and terminal
`
`disclaim provided and allowance «>me 1-11 and 13-23 are mqufilnd.
`
`
`
`Angela Mane Stone
`Agent for Applicants!)
`Wan No. 41,335
`(513) 622-3054
`'
`
`Sepmbez1i 1993
`5711!!“
`
`[TX/RX N0 9752] I008
`> 09/23/98 WED 12:46
`
`
`M2
`:29 /
`
`PAGE 000006
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`PAGE 000006
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