`
`
`
`ING or
`(c) DATE
`
`11/09/2007
`
`GRP ART
`UNIT
`
`60/986,665
`
`
`
`U\ I'I'IIII) S'I'A'I'IIIS DEPAR'I'M IIN'I' ()Ir' (IOM VIIIIIUH
`United States Patent and Trademark Office
`Address COMMISSIONER FOR PATENTS
`11.0. Box 1450
`Alexandn'a, Vngmia 22313-1450
`wwnspmgmr
`
`FIL FEE REC'D
`105
`
`ATTY.DOCKET.NO
`17487-63503
`
`TOT CLAIMS IND CLAHVIS
`
`24728
`MORRIS MANNING MARTIN LLP
`3343 333333333 3333, NE
`1600 ATLANTA FINANCIAL CENTER
`ATLANTA, GA 30326
`
`CONFIRMATION NO. 21 77
`
`FILING RECEIPT
`
`llll|l|l||ll||l|lll|||llIlIIlIIIlIIlIIIIITIIIIIIIIIIIIll||ll||||||l||||||||||
`
`Date Mailed: 12/21/2007
`
`It will not be examined for patentability and will
`Receipt is acknowledged of this provisional patent application.
`become abandoned not later than twelve months after its filing date. Any correspo ndenoe concerning the application
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`Applicant(s)
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`** SMALL ENTITY **
`Title
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`PLACENTAL TISSUE GRAFTS AND IMPROVED METHODS OF PREPARING AND USING THE
`SAME IN PERIDONTICS
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`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
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`effect as a regular national patent application in each PCT-member country. The PCT process simplifies the filing
`of patent applications on the same invention in member countries, but does not result in a grant of "an international
`page 1 of 3
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`MTF Ex. 1038, pg. 1
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`patent" and does not eliminate the need of applicants to file additional documents and fees in countries where patent
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`LICENSE FOR FOREIGN FILING UNDER
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`page 2 of 3
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`MTF Ex. 1038, pg. 2
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`Security, Department of Commerce (15 CFR parts 730—774); the Office of Foreign AssetsControl, Department of
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`page 3 of 3
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`MTF Ex. 1038, pg. 3
`
`
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`PTO/SBI14 (07-07)
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`Attorney Docket Number 17487—63503
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`PLACENTAL TISSUE GRAFTS AND IMPROVED METHODS OF PREPARING AND USING THE SAME IN
`Title of Invention PERIDONTICS
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`Daniel
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`GA
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`US
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`City Woodstock
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`301 Stillwater Cove
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`24728
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`jtodd@mmmlaw.com
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`Title of the Invention
`gkfinczEEIETSIE—FIIIESHESSAFTS AND IMPROVED METHODS OF PREPARING AND USING THE
`
`
`Attorney Docket Number
`17487—63503
`Small Entity Status Claimed
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`MTF Ex. 1038, pg. 4
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`PTO/SBI14 (07-07)
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`Attorney Docket Number 17487—63503
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` PLACENTAL TISSUE GRAFTS AND IMPROVED METHODS OF PREPARING AND USING THE SAM: IN
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`Address 2
`Suite 60
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`
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`City
`Kennesaw
`StatelProvince
`GA
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`PLACENTAL TISSUE GRAFTS AND IMPROVED METHODS OF PREPARING AND USING THE SAM: IN
`
`Title of Invention
`PERIDONTICS
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`Attorney Decker Nn.: 17487-13593
`P Ail“ E NT
`
`PLACENTAL TISSUE GRAFTS AND IMPROVED
`
`R’IE'I‘IJIUDS 0F PREPARING AND USING THE SANIE IN
`
`PERIODQNTICS
`
`{JR
`
`3 0‘
`
`FIELD OF THE INVENTION
`
`The present im'emion relamg generally m: tissue allografis and, in particular, :0
`
`placemal :‘nembrane iissue grafts; (amnion and sharing“) and merhods 01' premjring,
`
`pres wring. and l'ncaliwl uses for {he same;
`
`BACKGROUND OF THE INVENTION
`
`Humam placental membrane (fig amnimic nmmbrane or tissue) has- bcen used thr
`
`varirms types afreconsu‘uc-tive surgical procedures since the early @005. The membrane
`
`games as a substrate material, more mmnmnly refen‘ed to as; a bialugical {3:633ng 01‘
`
`patch graft. Such membrane has aim been used widcly fur mp'lilihalmic procedures in {his
`
`United Stills-S and in mummies in the southern hem‘isphfim.
`
`'§")-'picallly, such n‘r-embra'ne is
`
`Either frozen or drlad l‘m" .preSer\-=aiion and Stamge Lmlil mauled. for surgery.
`
`Such placemal liiasuz: is lypicaliy harvested filler an Elective Cesarean surgery.
`
`The plarscma has trs-‘Qprimary layers of lissm including amnimic membrane and uhurimr
`
`The 21mm Oil-:1 mentllarana is a mm-vascular tissue. film! is the innermostlaycr ofthe
`
`placemm and censisvis Ufa single.- laycr, which is attached in a basrzmem membrane.
`
`l‘IllSlOlUg‘lC-al e. [al.ualiml indicates lhai the membrane layers 0? the amniotic memln‘anc
`
`canals? of epilhelium cell‘s. thin reticular fibers {basement mmub fame), a {hick cmnpacl‘
`
`layer; and fibroblast layer,
`
`'l‘h'e fibrous layer of amnion {i.e., {he basement membrane)
`
`contains cell armlmring collagen types W, V, and V114 Tbs ClmriQn is also considered as
`
`part mfthe fetal nmn'brzxrm; hummer, the amnicxtic layer and chorlen layer are separate.
`
`and separable entities.
`
`skinniotis membram: and chorim: tissue. provide unique grafiing characteristics
`
`when used For surgical pmcsdums, iz‘istludlng providing at 1112111624. far Cellular
`
`migrutianfpro1ifermion, providing a natural hi0.l0gicail barrier, arr: lion-1mmunogenic,
`
`MTF Ex. 1038, pg. 8
`
`
`
`U2
`
`ll}
`
`Attorney Docket Nu: 1748163503
`PA'I‘ENTI‘
`
`prmrmm increased self-hmling, are susceptible 01“ being fixed in place using {iifferem'
`
`techniques including fibrin glue 01' suturing. Alida such grafis, wlwn pmpsrly preparad,
`
`can be stored al mom {empera’lure 1hr exiemled periuds Uf‘llfllt, without mead fur
`
`efrigel'ation or freezing, umil. needecl for a surgical. pmcedure.
`
`Known clinical proceduras or applications l‘br such amnion grails inslude
`
`Sclumiderian Membrane repair (Le. sinus lift), guided iissuc rc‘gcnemfion {GIRL general
`
`weund care, and. primary ClDSuTC nwn‘ibwne. Known clinical procedures or applications
`
`far such clam‘lon grafts include: biglagical would dressing.
`
`A dcmilcd 100k at the hisic-ry and pracedure for harvesting and. using “live”
`
`amniotic. tissue for surgical pmccdux‘es and a mealmd for harvesting and freezing amniotic-
`
`11' 3511-3 grafts ‘lh'r apl'ithalmic procedures is described in US Pal No. 6,132,142 issued m
`
`'l‘scng Which is incormmmfi herein by reference. in ils entirely;
`
`‘l‘here is a need far 'imprm‘ed pmcedurcs. fer hawesti-ng, pmtcgging anti preparing
`
`amnion and/0r clam‘ion tissue for 12119? Surgical gl'a'fling procedures.
`
`The-re is a need for imprm'eil pmcedurcs for processing and preparing multiple
`
`layers of amnim’l audfo'r chorio'n tissue 170$ later surgical grafiing proccdures.
`
`"lllmrr: is. a need fer preparing and filming such tissue such that the S’lmma and
`
`baSement Sides (if 1116. [issue are easily and quickly l-demiil‘lable by a Surgecm when using
`
`Such {issue in a surgical 'pmcechlrel
`
`For these. and many mker masons, {here is a general need fur a method l'ur
`
`preparing placenta msmbrane tissue. grails ibr medical uscr and that includtt‘s [11:3 slcps :11“
`
`slamming a. placenta fmm a. subject, cleaning the placenta, separating thc Ql‘iOI‘lQn fmm
`
`ll’lE amni‘atic mumbling“; dislnlbcling the chericm €321er amnimlc membrane, mouming a
`
`scammed layer Whither the ablation or the amnioticnmmbrane (mm a drying fixturci,
`
`claihydmllng the selectttcl layer an ilk: drying fixture, and cutting the seicctedlaytr into a
`
`plurality of l’lsguevgrafix. There. is an addilimml used fill: 21 drying fixture {hat includes
`
`gram-cs; 0r raised edges thai define the outer cnntnurs oft-rash desired tissue graft and that
`
`makes cutting of the grafts marl, accurate and 6333..
`
`'l‘hcrc‘: is a 'Fu'rtlmr nee-cl for a drying
`
`fixture: that includes raised. or Endented 1981051 textures; (lBSJgns, or text that emboss the:
`
`MTF Ex. 1038, pg. 9
`
`
`
`Attorney Docket No; 17487-63503-
`PATENT
`
`middle. area offhfit tissue gmfis during dehydration and {hat enables an. end user. to be able.
`
`m distinguish [he top surface from, the helium surface of the grail; which is often
`
`necessary tr; lumw prior 10 using, such grafts in a medical application er surgical
`
`pmceduref Such legu‘s, Textures? designs, or 12fo can be used fer lnlbrrrmli‘(anal purposes
`
`{)1
`
`car they can? additienally and advantageously be used for markeiing er advertising
`
`purposes. There is a new for grafts that are comprised of'singlc layers of amnion or
`
`chm-rem nmltiple layers r3‘l“anmir.m er Charmin, or mulriple layers of a eon-"lbmaiien of
`
`meme-n. and, ehorion.
`
`The present inn-melon meers one or mere of the abeve~refereneecl needs as
`
`ll}
`
`described herein ingreafier detail.
`
`SillllrilViAR‘r’ BE THE ENVENTI ON
`
`One emboclin‘iem or" the present invent-ion is directed to one or more methods of
`
`preparing placenta meJ-nbrane {issue grails, comprising the steps of obtaining 2-3 placenta.
`
`From a subjecti wherein the placenta ineludes an anmimle membrane layer and a ChOTlDTl
`
`tisSue layer, cleaning the placenta in a solution; separating the chmion [issue layer from
`
`the amnietir membrane layer, mounting a selected layer of either the clmrien tissue layer
`
`or the amulmir membrane layer £th a surface 01‘1er drying fixture. dehydrating the
`
`selected layer on the drying 'l‘ixmre, and thereafter, cutting the seleeied layer into a
`
`pluralily of placenta membrane lisaue galls. The placenta membrane tissue grafts can be
`
`either amniotic.membrane tissue grafts or cherion. tissue grafts. Since anmiotie
`
`membrane has a slmmal side and an apposite, basement. side, when dehydrating an
`
`amniotic membrane layer, such layer is mouniecl onto the drying fixture wiih the
`
`basement side .l‘ecing dawn and enamel side facing up.
`
`Prel’7erably,~1l1e drying fixture ineluder a texture or design adapted 1'0 embess sue-l1
`
`lcxmre or design 51121} the plattmta mer‘nbrmle tissue grafts during, the step Df (lehydraiiinn
`
`wherein the lexlure er design embessed intuihe placenta membrane liSSue enable a user
`
`m identify a lap and bermm surface el‘thie'plueema membrane rissue.
`
`Pre Terably, the placenta is cleaned- in a hypfirisomnic solutian wherein the
`
`m
`
`MTF Ex. 1038. pg. 10
`
`
`
`Attarney Bracket Nth“: 1748163503
`PATENT
`
`lrypm‘isotoni:c solution wmpris’as NaCl concentration in a: range. of tram abmlt 30% to
`
`abuut 3036‘
`
`In, smut? entbocfittrsnts, the metflmd further comprises the step 0'1: after scpai‘atian
`
`ut’ the (thOl‘lUn tissue: layer firm the amniotic membrane lat-r, snaking the selected layer
`
`Ur
`
`in an antibitatic solution. Optimrtally, the. method then also inuludrzs the step of rinsing the
`
`salcctcd layer to remove the antibiotic solution.
`
`tin 5mm: tambudirrtarrts, this mstlmd further includes the step 0f, after separatiun of
`
`this cttorian tissue layer from the amniotic mambrane layer, physically cleaning ths:
`
`selgtsted layer to renters bland clots and Other contmnittatcs.
`
`In ttt‘lmr ibaturcsl 1hr: step 01’ (lcltydrating thesalcated layer [11.111le comprises
`
`placing t‘liia drying fixture. in a hrmthablr: bag and heating the bag fur a- pradctern‘tin‘ed
`
`period utitimc.
`
`l-‘rc'l‘cmbly, the bag is. heatad at. a terttperature olf'tnetwacn 35 dag-eats. and
`
`56* degrees Celsius and the predeterminedperiod ot‘timc is betwcenfifit} and lEtl minute‘s,
`
`wherein 45 {tagrees Celeius and 45 mimrtes at" time in a non-vacum‘n (Wet Or incultalm‘
`
`1J1
`
`for a single layer oftissuc: gartttratly seems ideal.
`
`in one arrangement; the Surface. ot‘the drying fixture has a plurality 9f grooves
`
`that defines; the outer contours; ofeach of the plurality ofplacenta mambranc l'iSS'lic grafts
`
`and what-sin the step Ufa-titling comprises cutting the, selected layer along the gt‘ocwezs.
`
`In another arr'angt:mattrl-a tits Surface fifths drying fixture has a plurality afrairtcd
`
`edgefi that define the Outer contours 61" each of the pl uralitfy Qf placenta membrane tissue
`
`grafts and wherein the Step of cutting ccmrprises rolling a taller across the top of the
`
`selected? lay-Ct and pressing the seiectfid layer agairtgt the raised edges.
`
`In another that'ure, the method :l‘urther comprises ths Step (if mmmting one or more
`
`additional layers at chorion tissue (tr anmitttic layer onto the surface of the drying fixture
`
`prior to the step at“ dehydration to create it plurality of lmnimttcd placenta membrane.
`I
`tissue grafts having a thickness and strength greater than a single lath-fer of placenta
`
`r‘l
`
`in}
`
`membrane t'iixsue grafts.
`
`in a further tbature, each of tilt: plurality cf placenta membrantx ti ssrie. grafts i5
`
`tohycit‘ated prim to use Df the respectiva graft for a medital procedure.
`
`MTF Ex. 1038. pg. 11
`
`
`
`Atmrney Bucket Ne»: 17487“63503
`FATE N!
`
`in yci’ filrihctr i’sa‘lurcs. {hf present ‘inventian includes risisuc‘: grafts pl‘OCCSSCd and
`
`praparizd according [0 any 0f the methods Seacribcd herein.
`
`in another El]1i30d.in‘16fit_, the present inve‘mion is direutad ta 3 tissue graft that.
`
`comprises a {lehydraicit piacen‘ta tissue having a top and bomm surface and an outer
`
`:1
`
`cummir sized and shaped Em use in a suitable medical procedure, wherein a texture or
`
`design is embossed within the dehydrated? placenta {issue and wherein the Embossn'icnl
`
`distinguiéihes {he um from the {301mm surface of the placema tissue; and wherein she
`
`dahydrated, placenta tissue grim. is: usabls in the suiiabie medical procedure after being
`
`rehydramdi
`
`In a feature of this embedimcm, the dehydraied, piacenla tissue comprises
`
`If)
`
`either an amniotic membrane. layer ma chmion tissue layer.
`
`in yet anoiiier ’l’eature. the
`
`dehydfaifid? plan-11m iisme comprises two or 11mm layers of amniotic membrane and
`
`chariun tissum whcrain til-f3. M0 in“ more iayers include a plurality m“ amniotic membrane,
`
`a plurality of clmrion tissue, 0i 3 pluraiity (if amnimic membrane and chafimi tissue.
`
`Ti‘lE‘SG and mhei‘ asp‘flcts O’Fthe present inveniian will. became appai‘em from the
`
`L}!
`
`fbiimwing dcscripiimn fifths prefarmd e‘mhmiimcnt 32-11mm in coniuncliun wiéh the
`
`fiiiimwing drawings, although variatimns and iiio‘difications therein may be affected
`
`without departing from the spirit and scope of the: new]. concepts of the disclosure.
`
`U’x
`
`MTF Ex. 1038. pg. 12
`
`
`
`Atmrney Backet NIL: l7¢37~635fl3
`PATENT
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Further features anti benefits of the present inventmn will be apparent from a
`
`detailed de‘setiptioh ef‘ prefiermd embodiments thereoftaken in conjurmtnn with the:
`
`"frilltj‘wing drawingsj wherein similar Elements are referred 3'0. with Similar rethrence
`
`5}:
`
`mrmbers, and wlmrein:
`
`FIG. 1 is a high. tewl flaw chart of the primary steps perfumed in a prcferrcd
`
`embodiment 0f the present invention;
`
`FIG. ,2 is {-111 smmplary tissua ch‘eckin farm used with the: preferred Embudiment
`
`Of tits: :pressmt imr‘cntiun;
`
`FIG‘ 3 is art GXemplary raw tissue assessment. form used with the. preferred
`
`cmbadiment attire: present irwerttimt;
`
`FIG. 4 is an exemplary dehydration pmcess form used'with the pmfcrrcd
`
`Embodiment of the pa‘aserrt invamion;
`
`FIG. 5 is a pergpective View 01’ an exemplary drying fixture for use With a
`
`pmffirred errtbodiiittsm. mt the! pt‘C-SCJH. invention;
`
`F1G. {6 is a ISPI‘ESCDM‘UVC side View of the finmirjtic mambrzms tifisue [Gr
`
`periodontat use within an {rmbadi'merrt fifths present invention;
`
`FIG. 7 £5 a top View efths amniutic membrane tissue with a perfm'ate’d metsh for
`
`periodontal was within an emboditrtentj offha- prescnt invsntion.
`
`MTF Ex. 1038. pg. 13
`
`
`
`Atturney {111161161 1510.: 13187—63503-
`PATENT
`
`DETAILED DESCRIPTIQN OF THE PREFERRED EMBODIMENTS
`
`Thar 131656111 1113161111011 15 1111316 particularly (16561111611 111 1116 lbilnwing 611111119165
`
`and 6111b0d§11161115 that El‘G 1111611611361 as illustrative only 511166 11111116111113 modi fimtiens and
`
`11111111116113 111616.111 sail! 116 131391116111 16 $1656 511111611111 1116 311116116115 611113611111161115 011116
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`
`1111516111161 “1116" 11161616165 plural
`
`116176161166 u11less 1116 661116111 616111131 dictates 6111611111136.
`
`1.1111161, as 1.16611 1111.116 description
`
`11616111111161 throughout" 1116 61611113111611 follow, 1116 11166111119101‘ in11161111163 “111111161 “(111”
`
`11111633 {I16 66111661 6161111}: 6116111163 61116111136. 31161661161, 1111653 01‘ 56611116616616 ’66 115611 in
`
`1116 specification 16111316: 66111’611161166'61721 1666161; which 21161161 111161111611 10 111111161166 1116
`
`36696. of 1'l'16 917636111 11111611111311.
`
`(”1.1161111011111133 5111116 1611111; 115611 in 11113 3136561 {361111611 1116
`
`111616631*361266‘113611lly 1161311661 136161116
`
`V1111113111 11116111 111 “11111 1111: 361396 1‘3£ 111611.11611111111 62661171131111}:111311‘1111161113.
`
`119111116111115x 111611101151 and li’lC‘ll" 1'61111‘611 16311116116601111119 10111166111130dim6111‘s althe 9116116111.
`
`li'l‘v’iimlfln 616 3.1111611 below N616 1}at [11.611 01 31111111163 may" be used.111 the dissussian 11f
`
`6X61’1’1plary 61111306111116.1115 131’ 1116 1316116111 1111161111011 for COI‘IVfinifJnC-e of 51116111161“, which 1'11 110
`
`11111): sl111ul1‘llh1’11121l16 860131;? of the inventlnn. Mara-3131.161. certain 111601363 .1116 prep-011611 and
`
`disclosed 11616111; 116116-1161, in 111.1 way 11163.1, Wl'lfllhfll‘ 1116}; .2116 1*i ght 1:11: wrong, Should Iim 11
`
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`
`1111111111111 regard fer any 921111611 [111 themy or 561161136 6f action.
`
`OVERVIEW 0}? THE PROCE SS
`
`Tummg first 11?) {Tii: 1, M11613 level 613161View 100 6.1 lhe65116135 u11d61tak611 1'0
`
`1111166111. 1311366511, and 11.16131116- placental 111211611111 17131: 13161- 1156 as a.11111111g111l."115 disclnsed.
`
`TX}
`
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`
`1‘11.
`
`11 hinhl.616] inits‘allx 1116 plm:61116 US$111: is COllC6.16 clfrom 66111186111161; 9111i6111.l‘ri'llm'wing
`
`11.11 {Eli-SCETH-“G {16311161111 13111rg61y {111613 130). 11161111116116] is 91:6661‘11611611111.1111151113116111 in
`
`6611111111111161 11515116 91666116111011 11111111161: to a s11i111bl6 1316665311111, 101.511.1011 or facility 1111‘
`
`61166»l<111 11111161’1111121116n (516 p 1'20). 131st processing, handling. and separation 6f 1116
`
`MTF Ex. 1038. pg. 14
`
`
`
`Atmmey Bucket N11,: l?487~635tl3
`PATENT
`
`tissue layers then takes place (slap 1.3.0). Acceptabls tissue is than demutamina‘ted {step
`
`tit-U}, dehydrated (step 150}, out and packaged (step lfiOLand reieased {step 170) to the.
`
`market for use! by surgeons and rather medicat‘pmfijssiomts in sppmpriats: Surgitzal
`
`procedures and for wuund care.
`
`‘Jt
`
`Initi 211' Ti ssue Cnilectimg t Stats 1 i0}
`
`’1‘1123 recovery 0't7placenm tissue QI‘iginfltGS in. a l‘mspitgllp xarliere it is ctollectsd
`
`d'tii‘itig a Cesarean section birth. "the-timing referring to the. mather who is almmtto giw:
`
`birth, voluntarily submits to a comprehensive screening process designed to» provide. the
`
`it)
`
`sal'hst tissue possible for tr‘aiisplanttttim. "The screening process prefm‘ab'ly tests rm
`
`antibodies to the. human immmmdeficimay virus, type i and typt: 2 (anti-liiV—i and anti~
`
`HIV—2L Ilispettitis B Surface antigcns {HIBs-Ag), antilmtiics to the hepatitis C’VETHS {ami-
`
`l-ICV), antibcdics to the human ’lllymphatropic. virus type: i and type II (antiaivl’l‘liV—i and
`
`anti-HTLV-ilL CMV, and syphilis, using cmwcntioi‘ial SCTQ-lflgicai tests. 1113'is2 list
`
`‘15
`
`attests is examplary mil}; as more, rim-Er, or different Vttzsts may hit {lasit‘ed or necessary
`
`aver time or based upmt the intended use cafthe gratis: as will be apprgci-at-cd by those
`
`skilled in the art.
`
`Based upon a ‘t'C‘r‘tCW 05th:: donor’s titlbtfn'tatimi and Stll‘fifjfllflg test results, this
`
`dunes will either be: dCC-I‘Kicd acacptaatblc or net.
`
`In addition, at the time of delivery;
`
`30
`
`cultures are taken to dctsrmine the presence 0:1: {bi emanate, Ciostrialium 0r
`
`SitcptocDC-cus.
`
`l'fithi: dt'lnmfjs infm‘matiom screening tests, and the delivery cultures are
`
`all nsgative (1.62,, do not indicate any risks 01?" indicate acceptable level of risk}, the clamor
`
`is apprwcd and the tissue spacimcn is designated as initially eligible for l’urtlisr
`
`J
`
`5}:
`
`tar-imaging and evaluation.
`
`Human placentss "that inset the abut-'3 salection criteria an: pi‘cl’crablt bagged in a
`
`saline sslutinn ”m a sterile shipmem bag and stared in a container of wet ice for shipment
`
`t0 :1 processing location
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