UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: (i()l\/lVI]SS[()N}-{R FOR P/\'l'|-INTS
`P.O Buy. 1450
`Alexandria. Virginia 22313-1450
`wWw.uspto.g0v
`
`yea
`47
`it
`‘ 5 UNITED STATES PATENT AND TRADEMARK OFFICE
`-
`-
`5
`
`
`
`
`APPLICATION NO.
`FILING DATE
`FIRST NAMED INVENTOR
`ATTORNEY DOCKET NO.
`CONFIRMATION NO.
`7585 90/013,678 01/08/2016 8318430 465l57L'Sll0RX
`
`
`
`
`
`
`
`
`
`02/17/2016
`7590
`97262
`Wilson Sonsini Goodrich & Rosati - Verinata
`650 page Mill Road
`Palo Alto, CA 94304
`
`EKAMNER
`
`PONNALURI, PADMASIIRI
`
`3991
`
`MAIL DATE
`
`02/17/1016
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`|PR2013—00277
`
`Ariosa Exhibit 1053, pg. 1
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 1
`
`

`
`TJNJ. TED ESTATES PATENT .€3'.NIJ
`
`OIE‘FlCE
`
`Cnrnrhlssinnsar for Pete ms
`United States Patent and Tradernark Office
`P.O. EIo><1450
`Alexaridria, VA 223-l 3-1 450
`uuwnwspro gov
`
`DO NOT USE IN PALM PRINTER
`
`(THIRD PARTY REQuESTER'S CORRESPONDENCE ADDRESS)
`
`OBLON, MCCLELLAND, MAIER & NEUSTADT, LLP
`
`1940 DUKE STREET
`
`ALEXANDRIA, VA 22314
`
`EX PARTE REEXAMINATION COMMUNICATION TRANSM|'|'|'AL FORM
`
`REEXAMINATION CONTROL NO. 90/013 678.
`
`PATENT NO. 8318430.
`
`ART UNIT 3991.
`
`Enclosed is a copy of the latest communication from the United States Patent and Trademark
`Office in the above identified ex parte reexamination proceeding (37 CFR 1.550(f)).
`
`Where this copy is supplied after the reply by requester, 37 CFR 1.535, or the time for filing a
`reply has passed, no submission on behalf of the ex parte reexamination requester will be
`acknowledged or considered (37 CFR 1.550(g)).
`
`PTOL-465 (Rev.07-O4)
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 2
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 2
`
`The present application is being examined under the pre—AIA first to invent provisions.
`
`Reexamination: Granting of Request
`
`Procedural Posture:
`
`Third Party Requester’s request for ex parte reexaminafion of claims 1-30 of US Patent
`
`Number 8,318,430 to Chuu et al filed on 1/8/16 is acknowledged.
`
`Decision Granting the Order
`
`A substantial new question of patentability affecting claims 1-30 of US Patent 8,318,430
`
`(the ‘430 patent) is raised by the request for reexamination.
`
`Information Disclosure Statement
`
`The Information disclosure statement (PTO/SB/08) filed on 1/8/16 by the Requester is
`
`considered.
`
`Priority
`
`US patent 8,318,430 was issued from application 13/368,035, filed on Feb. 7, 2012;
`which is a Continuation of application 13/012,222, filed on Jan. 24, 2011, now
`abandoned;
`
`Which claims priority to Provisional application 61/297,755, filed on Jan. 23, 2010.
`
`Substantial New Question ofPatentability (SNQ) Raised By the Request
`
`For “a substantial new question of patentability” to be present, it is only necessary that:
`The prior art patents and/or printed publications raise a substantial question of
`A.
`patentability regarding at least one claim i.e. the prior art teaching is such that there is a
`substantial likelihood that a reasonable examiner would consider the teaching to be important in
`deciding whether or not the claim is patentable; and it is not necessary that the prior art establish
`a prima facie case of unpatentability and;
`B.
`The same question of patentability as to the claim has not been decided by the Office in a
`previous examination or pending reexamination of the patent or in a final holding of invalidity
`by the Federal Courts in a decision on the merits involving the claim. See MPEP 2242.
`For a reexamination that was ordered on or after November 2, 2002 (‘the date of
`enactment of Public Law 107-273; see Section 13105, of the Patent and Trademark Office
`
`Authorization Act of 2002), reliance solely on old art (as the basis for a rejection) does not
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 3
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 3
`
`necessarily preclude the existence of a substantial new question of patentability (SNQ) that is
`based exclusively on that old art. Determinations on whether a SNQ exists in such an instance
`shall be based upon a fact—specific inquiry done on a case—by—case basis. For example, a SNQ
`may be based solely on old art where the old art is being presented/Viewed in a new light, or in a
`different way, as compared with its use in the earlier concluded exarr1ination(s), in View of a
`material new argument or interpretation presented in the request. MPEP 2258.01.
`
`The Chuu ’s Patented (the ‘430 patent) Invention
`
`Claims 1-30 are currently subject to reexamination proceeding. Claims 1 and 19 are
`
`independent claims and claim 1 is reiterated below.
`
`Claim 1. A method for rletertrnniilg a presence or absence of a fetal aneuploitly in
`each of a plturality of maternal blood samples Ol‘1l.'8.lIl6£l tron: a ;'.sE:n‘allty of different
`pregnant. women, sairl rnaternal blood sarrlples C<.>lil1{.‘?l,'l,Sll'lg "fetal and maternal eeltlwfree genoritie
`IJNA. said method a:on1pn'sing:
`la)
`-ribtalrilng
`and maternal a;'ell—t‘ree genomls; lC)NA SE1i'l‘:p:l€.
`Weaternal blood samples;
`
`l’..l‘t’)F11,€EL&;‘l3 oltbe plurality of
`
`fetus for
`
`selezztively en ri::l1ln_.<g 2'l.pl.‘l1J'?illl.'j;' of n-;:n—randon'1 nolynuc:le<':tl<le sequences of ezlel: fetal ancl
`(la)
`tnatenial eell—fre-e genomic DNA S§§,lTll?-la) of (a) to generate i;l library €.l€.l‘l\/Cd
`from each fetal and
`maternal s:ell—free genomic l)N/-2 saitiple of enrlchetl and lnderxecl fetal and maternal nomrandonl
`polynneleotide seqneliees. Wl'1<:?l“E:lIl eaeli l,ibr-my of enrlt:bee'l ané. indexed ,l"<:‘.‘t,-al anrl l’l‘lE1‘f,f:1‘rl,'(ll non-
`1':i1‘l(_l0111p0l}’l11.H.‘l€O’€l§.l§_?
`sequences inelugl-es an iiidexiiig nucleotide sequence which identifies a
`maternal blood sample of the plurality ol‘ rnalemal blood samples,
`I.‘l,llll'4-f.‘.I'-f.?l'1‘l,
`‘Wllf.§l,‘t.’.l,Fl
`:9.znr.l r_>l.i1i*alily of n<'>n~randon‘1 §}€_‘rl:§Fl‘ll.lClt§OlJ_lEi€.5
`st:qut:r:=.ees ;:ornpl'lses at least. l€l=Cl
`non--ranllom pol;.'nueleotii:le sequences selected. ll‘Dl“l‘l a first ehroinosonie testecl for belong
`aneuploltl and at l,east l 00 different l'tOll—I‘2-.l'lvL'lOl“l’l polynuszileotitle sequences seleclescl t‘rotn a
`refei'e.nee c.?ln'o,mo.sen1e. wherein the first ehroniosorne tested for being aiieuploitl and the
`reference ssliromosorne are tlifferent, and wherein each of
`plurality of non--rand orn
`p<_ll.yi'1neleot,lde seqnetaees is l:l%'orn 10 to lllljll nocl,eotitle bases in leng:t}a,
`
`lb‘; to protlucse a pool. of enrielied and inrle ed fetal and
`pooll.i‘1g the l.ibra.ries ;__tenerate<l
`(cs)
`maternal l1C»l‘l--1'3ll{lOE"l“i pr-lyiiits: leotirle sequences;
`
`perforrning inassively parallel seqnenlsing of the pool of enricl1ea:l and lndexesl fetal and
`Ed)
`maternal non—ranrl<_>in pnlyntleleoticle sequences of (C) to p_l‘=.'){'l.‘:i£2€ seqiienee rearls c:orl'espoi'1dlng
`to enriched and imiexed fetal and tnaternsfl non—rantlon1 pe-lyiineleotide. seqlieintes of each of the
`at least lillil different non-randorn p0:l§,’ll':.1€3:lt30ll(3l€5
`sequences selected {Tr-;‘,~n'i tlie first cltrolnosome
`tested for being; aneuplo,lt_l and :~‘.equen<:e reads c:orrespon«;i.ing to enrlel*:e.<l 3.l’:(l
`in-rlex-s_=cl fetal and
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 4
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 4
`
`matema3 non-random p<3}yra‘ueie0tide sequences» of each of the at ieazat
`p:_>}y:'1u<:3e0ride '~;e:';;uer:ee.<‘. szeiedied from ‘fine referemxe c‘r1rc;m<'>.~s0n‘1e;
`
`.100 difl"eren=; nou—1‘andon1
`
`based on the inciexing nucleotide :~geque11ce,., for each of the plurality of n13.terr121i blood
`(e)
`samples, enumerating sequence :'ead:~; s:orr+:.spondingj to enriched and indexed fetai sand matermi
`um1~r:1ndom praljm::e}.ez':tide seqL1e:1;‘e:5 (selected ’é"rx.';sm.
`the
`‘tit ehrm‘m‘:a<.m'1e zesteci
`f«.'3:’being
`aneupieid aurd ~36-qua-use re'a.<:Es eer‘r‘egp<_\r1a.iir1g Loer1r‘i<.*11ed and i11de,\;ed fem} 5:11-:1 1£13.i.€.’i'l1:‘J.1
`110:1-
`random poiyr1uC}eotici.e :x;eq‘ue‘nees aeiecieci irorn the referensze chromosome; and
`
`for each of the ;':Eur:11ity 0f1‘nat£:_z‘m1E blood samrples, cleiermining the presence. -::,=r absence of
`(37,)
`a fetal ;meup1<_:iciy eorrlprising uzeing :1 11121113391‘ of enumerated se.que.11ee. reads e0rre;~,;p:_111di11g to
`the first chromossgmrs and .1 number of -:=z:umerated sequence reacls CCr1‘1’ESpO11d.iI1g ‘(Q the referem:e
`chro.mr_>som.e of { 3.
`
`Document cited in the Request
`
`U.S. Patent No. 7,332,277. Issued on Feb. 19, 2008 to Dhallan (hereinafter "Dhallan I")
`1.
`(EXh.C).
`
`2.
`E).
`3.
`
`US. P§1€‘,e:“31' Pub. App. No. 200€»,’0l2‘i-452 to ET}h;13Ean FF (§'1erein;1fLer“E}%13§E:Im H”) (Eixh.
`
`Craig et
`
`Nat. Methods, 5:11 (3):887—93 {Z003} (herei;:aftez‘ "‘€:Iraig”’)
`
`(iiixh. E? and Q),
`
`Jonas Biniadeil e‘: 211., PLeS GEE. 2007; 2(2): e197 {he1'ei11af’zer “Bir;iaden’°} (Exh. D).
`
`Iihamiraa E%r::»e§'n.:re “]\/Iultipiexed Sequencing Wiih flae H1m'ni1'2:3. Genome Aruzaiyzel‘ .‘3y:<:iem” {"2008}
`5.
`(he:"einai’Ler' ‘iiiuiniriza 2¥I}€}8”_)
`ILEXE1. U).
`
`Paramesv ‘:”£iFi, et 3]., Nucleic ,,A,eic1:»,1 Resea.r‘eh, 35;’_ E97,‘-:e‘§30 (2907) (herein::E7t.er
`6.
`*‘P2ar*ames;waran"’) (Exh. H and S1).
`
`E-L'.u‘nad;«‘. er z'.:,E,., Nat. _'=.‘vie1'heds,, 5€jfi\}:23§»3'7 (3008) {_31e:“e:3r;,af1'eJ' “Ii-§ara%a£§}’”) {Ex.E:1. 1).
`
`US. Patent P”-ab. App. No. 20(38:’(3(}‘9G239 to Shsjemaker, et al. {hereinafter “S§mem:akei"”)
`
`(EXE1. J).
`
`E)}1a}Ezm E {EEixh. {,7} and Eiiniaderi were used in the inter Furies Reviews 3(f333-=CE=T)27{i and
`
`00277. The gm’?-rind -;:m1si¢fle1'r3c1 in the B§’i~‘t involved Shoemaker‘ a.<; prima1'yreferene:3 and Dhaiian
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 5
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 5
`
`E and Biitiatien were used as secondary ret‘ei'enees. H<_>weve2', no final dezsision was issued in
`
`these IPRS. E§7u.rthe:,', Dhaiian ii is presented in a new light in view -;',~fl§—,iitladen in this request.
`
`llluinina 2068 (Exh. G) was used in the application that resulted in the _pr:.=sent ‘£133
`
`patent. E-imvtswsr,
`refei‘eiiees.
`
`this request, il,ii.11’Ji‘:lJ'}£1 2=I)i)?§ is 11st:<'i in a new }.i;_zht in <:ornbir:atien with miter
`
`Dhallan ll, Craig, Parameswaran and Hamady were neither cited nor used to reject the
`claims in the application that resulted in the present 430 patent.
`
`Eilwemalcei‘ iiiixh. J) was not used to raise 593542); in this iieqtiest.
`
`Additional Documents/Exhibits
`
`The Request and the Information Disclosure Statement filed on 1/8/ l6 included Exhibits
`B, J —P, R, T—W, which are not used to raise SNQ, which are either evidentiary references or only
`used to show the state of the prior art.
`
`Declarations
`
`Dr. Rosenberg Declaration (Exhibit 0)
`
`The Requester discussed the Rosenberg declaration and the documents cited in the
`
`declaration.
`
`The reexamination proceeding provides a complete reexamination of the patent claims on the
`basis of prior art patents and printed publications. (See MPEP 225 8).
`
`Affidavits or declarations which explain the contents or pertinent dates of prior art patents or
`printed publications in more detail may be considered in reexamination. See MPEP §2258.
`
`Since the Rosenberg declaration is neither a printed publications nor a prior art patent, the
`
`declaration by itself does not raise SNQ. However, the declaration may be used in combination
`
`with other prior art to reject the claims.
`
`Discussion of the cited documents and SNQ
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 6
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 6
`
`The Requester considers that a substantial new question of patentability of claims 1-30 of
`1.
`the ‘430 patent is raised by Dhallan ll (Exh. E), Craig (Exh. F) and lllumina 2008 (Exh. G)
`(Request pages 31-34 and 39-64).
`
`Diiailan ll describes obtaining bleed samples f1’iJ11‘l multiple pregnant wiani-er‘:
`
`isolating
`
`cell,-'fi'ee DNA _l"_s.'t‘::‘_':.: tllese Si’l.l‘l.l}'ll€.‘>\
`
`1‘iiel,ln>:5;,<_; _l"o_r ain.plil’icatinn {sele<;tis;e eii.ricliii'1ez‘;.tl til" lien-
`
`random pelynucleotisies for the plurality of maternal samples llllliilill and [t")lZ7]._ detecting the
`
`hen-ranclmn ;iel;.rniiclentit'les for a pllll"<ll,l‘l,j," of maternal S¥il‘Tl,plc‘3:S, fiti,l1l‘Ti,t':I‘al'l,ll_g (_ceiin‘t,ing‘,l alleles
`
`at loci of interest, ancl comparing l'&lClQ_~; of alleles at the enriehecl (9.3-., aiiiplifietlfl lie-it--random
`
`p:_ilyiiticleotitl-es to i.‘lCE€‘.l”l‘i’i_‘il’1€ a i.?l11'0l1‘lfJSOlIlal abnorinality inclii-:.lii'ig-g a fetal anenploiily [0047 and
`
`Qll{i2:l. ‘v'ztri-ails nietiiods are {l’l24.(.3l-J§14:(;‘£1l to detect the zsequeilce ell" alleles lllllfill, ililiiél.
`
`Craig describes a polyiiucleoticle i.lClt.’.ClOi‘l€Cl1i’ll£li.lC using barcotl-:?d (“iii«;lexetl°’}
`
`iiiultiplexed seq uencing of selected nucleic acids froin tliilereiit hum-an ll‘LdlVl,fl'i1ZllS. Craig
`
`discloses that the sample sequences fI’C)“:”l1 different ihclividuals; were initially arnpli ed and
`
`prielecl prior t0 the ligation ol" the liai'c:_ié.es {indexes} {page 2 in Ex p£:‘.l,'li‘Tlt’:1‘l’f3l tlesigii and
`
`Methods in page ti‘-. ljiraig attacliecl the sample indexes (listed in 'lT'a‘l7-le 3‘; to the selected. nucleic
`
`acids by ligation l_Ai’3Sll‘1iClt Figiire l and page 2). After ligatimi, the samples lroni all individuals
`
`were pooled into a sitigle sample =fi*et‘ei‘retl to as indexed liln‘ai'y), puitilied, eiiriclied by PCR anal
`
`s-eqiieiieed on the llliiniina GA (page 2}, Oiice ll‘ls‘.’. copies of the selected nucleic a-:i=;ls W-‘sic
`
`seq aeiicetl, the sea nenees ol‘ S€lt3C'l€t’l
`
`iiticileic acids {rent each Sanipile could he gr‘-atipe-gl by virtue
`
`of the saniple index fer ll.l1'Ll'i€l‘ arialysis {that let the secjiieiices W-‘sic "-Lleeoiivelutszrci"' into sari1ple--
`
`specilic l'Jli'lSi.
`
`lllumiiia EL‘-C"8 discloses that a 5:“-t3llDlTi-.3 Aiialyzer kit is available to make rnnltiplexetl
`
`Ss’:‘.qll€llCll’l,g, and tes that the m'ul,tiple:<ed sequencing is 'l,'as=.er and chea per than ll‘.5l€lil'l0lliil,
`
`massively parallel sequencing“ ln the niiiltiplexecl sequeiiciiig; §’l'lt3l.llClCl_ DNA ll'lIil‘3.l'lCS are
`
`““t2i.;g_:;_::t=:(l" with tlY.E.l{l‘:.‘€:
`
`l-(l»‘:l'1‘l,l tier Oi“ index, :i.iitin.g.¢: sarnple }’3l”C‘pE!l‘;’l‘;i.€_lll,
`
`,t~/l iilti1*ale .<ra.r:=::nles are llieia
`
`pnelezi into a single lane on El llow cell anal then 5e€iZ}'l1€l’lCf§Cl
`run.
`
`together lll one (:i‘:':l’lOl’l'téi
`
`.»?xaial‘y;_ter
`
`There is a substantial likelihood that a reasonable examiner would consider these
`
`teachings important in deciding whether or not claims 1-30 of the ‘430 patent are patentable.
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 7
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Accordingly, the combined teachings of the Dhallan II, Craig and Illurnina 2008 raise a
`
`substantial new question of patentability as to claims 1-30 of the ‘430 patent.
`
`The Requester considers that a substantial new question of patentability of claims 1-30 of
`2.
`the ‘430 patent is raised by Dhallan II (Exh. E), Parameswaran (EXh.H) and Hamady (Exh. I and
`R) (Request pages 64-97).
`
`The teachings of Dhallan II are as discussed above.
`
`i’at'ai1ieswat‘::-.n utilized sample indexes (i.e., “liai‘eodes”) in conjunction with high-
`
`tluoughput pyroseqoelicing on the (3320 Sequencer (454/Rfitltf) to siitiuitaneotisiy‘ setguehce
`
`nucleic: .~3s:id. li’lir3i'ie‘~: from irtcleperlcleiit sets of 25 bai'cod.ed. libraries. Par'ai7ier~;w.ai'aii added. the
`
`har::ot'ie:~‘. to the n=.:e‘seic acids of intere.<;t' hy including the lJ(;ll"€€}£i~f.?S
`
`in the primers usetl to amplify
`
`the nucleic acids of interest, Using the hztrwding technique, Pai'ameswaran et al. vet:-:::rt that their
`
`py'1‘oseqt1eiieing batttodeti appmach ;a.llc»‘»~'~«'etl for the uiiambiguous assignment of riucl-:>.ic acid
`
`sequenees from 2: mixture of librai'ies frotii up to 48 tlifferent samples (page 8).
`
`Halriady teaches t’_’.l'l'D£”--COl”l‘r6i.“ilI1g Dlkl/3‘; bzti"eoa.les Ll:-L-.4: allow one run {if a 11lEtSSi\:’Cly
`
`parallel pyrosequetwer to pwszess up to l,5<£-4 samples simultzmetausly (Abstract). l-§zn‘ita<.i'y
`
`Cleinaiistrates that the use of the sample indexes with the Roche.-‘£54 massively parallel
`
`seqiienelng system would liave had suifieleiat detection etficieney to allow detection of the
`
`presence or ahsen-ee of fetal aheuploidy in multiple maternal samples analyzed simultaiieeiisly.
`
`There is a substantial likelihood that a reasonable examiner would consider these
`
`teachings important in deciding whether or not claims 1-30 of the ‘430 patent are patentable.
`
`Accordingly, the combined teachings of the Dhallan II, Parameswaran and Hamady raise a
`
`substantial new question of patentability as to claims 1-30 of the ‘430 patent.
`
`The Requester considers that a substantial new question of patentability of claims 1-30 of
`3.
`the ‘430 patent is raised by Dhallan I (US Patent 7,332,277) (Exh. C) and Binladen (Exh. D)
`(Request pages 97-135).
`
`Dhallan I discloses methods for detection of genetic disorders and specifically discloses
`
`non-invasive methods for detection of chromosomal abnormalities in a fetus (Abstract). The
`
`method is especially useful for detection of aneuploidy, polyploidy, monosomy, trisomy, trisomy
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 8
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 8
`
`21, trisomy 13, trisomy 14, trisomy 15, trisomy 16, trisomy 18 and trisomy 22 (col. 26, lines 2-5)
`
`in the blood samples of a pregnant women (col. 16, Lines 32-37). The blood samples are
`
`prepared to obtain cell-free fetal and maternal DNA (template DNA) (col. 31, lines 44-48). The
`
`template DNA is amplified using known methods (col. 47, lines 38-46; 48, lines 6; 66, lines 31-
`
`34).
`
`Binladen discloses conventional PCR method with 5‘-nucelotide tagged primers to
`
`generate homologous DNA amplification products from multiple specimens, followed by
`
`sequencing through the high-throughput Genome Sequence 2OTM DNA sequencing system
`
`(GS20, Roche/454 Life Sciences). Each DNA sequence is subsequently traced back to its
`
`individual source through 5‘—tag analysis (Abstract). Binladen demonstrates that the 5‘—primer
`
`tagging is useful method in which the sequencing power of GS2O can be applied to PCR—based
`
`assays of multiple homologous PCR products (Abstract).
`
`The combination of Dliallan l and Binladen present-r:cl herein relies on the
`
`sequencing tecirnques of Dlmllan lbeing replaced by those 5.e.sei'ibed in Binia<'ien
`
`rnultiplexed inassiiv-sly parallel seqnencrihg). "l‘his; particular ».’;-.":-i‘iril‘riiiati:7.-ii of lifiliallazq ii and
`
`Binladen was not C(.‘=i‘:S-Li£‘lCi'tB<.i during the e><a.mina'tion of the applicati:_m or in other ;;*.>roeeedings.
`
`The ground considered in the TPR i'twol'~/ed f§ZEioemal<er‘s seqiaeitcing techniques beirzg
`
`iriodifieii only to inciude the use of extrac.-elliilai‘ DNA (from Dliallan I) and nniitipiexiiig
`
`samples from 1l1L1l?.i;'§i€ patients (from :i?i‘ii}:l;'lClt5F1:}. /-M':C01'dl£}gi 5/, the C-f,‘1’i'J‘l‘Eii1l1'ElO'!”1
`
`lifihallan l and
`
`Biriladen provides 3. i:eehr1i:.*ai teacliing wlii€.*l"i
`
`missing frorn the appliizd prior ar=..
`
`There is a substantial likelihood that a reasonable examiner would consider these
`
`teachings important in deciding whether or not claims 1-30 of the ‘430 patent are patentable.
`
`Accordingly. the combined teachings of the Dhallan I and Binladen raise a substantial new
`
`question of patentability as to claims 1-30 of the ‘430 patent.
`
`In View of the above, the request for reexamination of claims 1-30 of the ‘430 patent is
`GRANTED.
`
`Conclusion
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 9
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Patent Owner Amendment
`
`Patent owner is notified that any proposed amendment to the specification and/or claims
`
`in this reexamination proceeding must comply with 37 CFR 1.530(d)—(i), must be formally
`
`presented pursuant to 37 CFR 1.52(a) and (b), and must contain any fees required by 37 CFR
`
`1.20(c).
`
`Waiver of Rights to File Patent Owner Statement
`
`In a reexamination proceeding, Patent Owner may expedite the reexamination proceeding by
`
`filing a waiver the right under 37 C.F.R. 1.530 to file a Patent Owner Statement. The document needs to
`
`contain a statement that Patent Owner waives the right under 37 (I.F.R. 1.53() to file a Patent Owner
`
`Statement and proof of service in the manner provided by 37 C.F.R. 1.248, if request for reexamination
`
`was made by a third party requester, see 37 C.F.R. 1.550(0). The Patent Owner may consider using the
`
`following statement in a document waiving the right to file a Patent Owner Statement:
`
`Patent Owner waives the right under 3 7 C.F.R 1.530 to file a Patent Owner Statement.
`
`Ongoing Duty to Disclose
`
`The patent owner is reminded of the continuing responsibility under 37 CFR 1 .565(a) to
`apprise the Office of any litigation activity, or other prior or concurrent proceeding, involving
`Patent No. 8,318,430 throughout the course of this reexamination proceeding. See MPEP §§
`2207,2282 and 2286.
`The third party requester is also reminded of the ability to similarly apprise the Office of
`any such activity or proceeding throughout the course of this reexamination proceeding. See
`MPEP §§ 2207, 2282 and 2286.
`
`Future Correspondences
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Padmashri Ponnaluii whose telephone number is 571-272-0809.
`The examiner can normally be reached on Monday through Friday between 7 AM and 3.30 PM.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`supervisor Jean Witz can be reached on 571-272-0927. The fax phone number for the
`organization where this application or proceeding is assigned is 571-273-9900.
`Information regarding the status of an application may be obtained from the Patent
`Application Information Retrieval (PAIR) system. Status information for published applications
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`applications is available through Private PAIR only. For more information about the PAIR
`system, see http://pair—direct.uspto.gov. Should you have questions on access to the Private PAIR
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll—free).
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 10
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`All correspondence relating to this Ex parte Reexamination proceeding should be
`
`directed to:
`
`By EFS:
`
`Registered users may submit via the electronic filing system EFS-Web at
`
`E1ttps://efs.uspto.goviefile/myportal/efs-registered
`
`By Mail to:
`
`Attn: Mail Stop “Ex Partc Rccxam”
`Central Reexamination Unit
`Commissioner for Patents
`P. O. Box 1450
`Alexandria VA 22313-1450
`
`By FAX to:
`(571) 273-9900
`Central Reexamination Unit
`
`Hand-Deliver any communications to:
`Customer Service Window
`Attn: Central Reexamination Unit
`
`Randolph Building, Lobby Level
`401 Dulany Street
`Alexandria, VA 22313
`
`/Padmashri Ponnaluri/
`
`Central Reexamination Specialist
`CRU -3991
`
`/Johnny Railey/
`Central Reexamination Specialist
`CRU -3991
`
`/Jean C. Witzl
`
`Supervisory Central Reexamination Specialist
`CRU -3991
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 11
`
`

`
`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 12
`
`

`
`Order Granting Request For
`Ex Parte Reexamination
`
`Control No.
`
`90/013,678
`Examiner
`
`Patent Under Reexamination
`
`8318430
`Art Unit
`
`PADMASHRI PONNALURI
`
`3991
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`
`The request for ex parte reexamination filed 08 January 2016 has been considered and a determination has
`been made. An identification of the claims, the references relied upon, and the rationale supporting the
`determination are attached.
`
`Attachments: a)I:I PTO—892,
`
`b)XI PTO/SB/O8,
`
`c)I:I Other:
`
`1.
`
`The request for ex parte reexamination is GRANTED.
`
`RESPONSE TIMES ARE SET AS FOLLOWS:
`
`For Patent Owner's Statement (Optional): TWO MONTHS from the mailing date of this communication
`(37 CFR 1.530 (b)). EXTENSIONS OF TIME ARE GOVERNED BY 37 CFR1.550(c).
`
`For Requester's Reply (optional): TWO MONTHS from the date of service of any timely filed
`Patent Owner‘s Statement (37 CFR 1.535). NO EXTENSION OF THIS TIME PERIOD IS PERMITTED.
`If Patent Owner does not file a timely statement under 37 CFR 1.530(b), then no reply by requester
`is permitted.
`
`/Padmashri P0n11aluri/
`
`Patent Reexunlinalion Specialist
`CRU 3991
`
`if third art
`cc:Reuester
`U 8 Patent and Trademark Office
`PTOL—471G(Rev_ 01-13)
`
`reuester
`
`Office Action in Ex Parte Reexamination
`
`Part of Paper No. 20160126
`
`IPR2013-00277
`Ariosa Exhibit 1053, pg. 13