UNITED STATES PATENT AND TRADEMARK OEEICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVIISS IONER FOR PATENTS
`P.O Box 1450
`Alexandria. Virginia 22313-1450
`www.uspL0 gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAM ) ENVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`90/013,678
`
`01/08/2016
`
`83
`
`465157US110RX
`
`7585
`
`02/17/2016
`7590
`97262
`VVi1son Sonsini Goodrich & Rosati - Vcrinata
`650 page Mill Road
`Palo Alto, CA 94304
`
`E Hwhk
`
`PONNALURI, PADMASHRI
`
`3991
`
`MAIL DATE
`
`02/17/2016
`
`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)
`
`IPR2013-00276
`Ariosa Exhibit 1053, pg. 1
`
`

`

`T..II\1ITE'l'J $'.['£3.TEE:1 PATENT ANIJ
`
`OFFICE
`
`Cnrnrnissinner for Patents.
`United States Patent and Trademark Office
`F'.O. EID}{‘I45U
`Alexaridria, VA 2231 3-1450
`‘1Ii!\I\A|\FAJS[2fT0.Q0‘I
`
`DO NOT USE IN PALM PRINTER
`
`(THIRD PARTY REQUESTERS CORRESPONDENCE ADDRESS)
`
`OBLON, MCCLELLAND, MAIER & NEUSTADT, LLP
`
`1940 DUKE STREET
`
`ALEXANDRIA. VA 22314
`
`EX PARTE REEXAMINATION COMMUNICATION TRANSMITTAL 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 (Flev.O7-04)
`
`IPR2013-00276
`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-AlA first to invent provisions.
`
`Reexamination: Granting of Request
`
`Procedural Posture:
`
`Third Party Requester’s request for ex parte reexamination 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
`
`IPR2013-00276
`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 examination(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 l—30 are currently subject to reexamination proceeding. Claims l and l9 are
`
`independent claims and claim 1 is reiterated below.
`
`Claim 1. A method for <.lei,e.rinining a presence or absence of a fetal aneiaploi-zly in a fetus for
`each of 3. plurality et‘niate1'nal lzlcoocl samples olitaine-Jl from": a pluralicty of t1ll,l‘l’,ls3t’-fillt
`pregnailt women, :sal<'l niaterr:=.al blood samcples C<JJil1pl,’l.S,lIl g fetal and i.”3‘lEllii°:_l‘Ild,l cel.l~l‘ree genomic
`l)NA. said l'i’1€‘.lll0(l. coniprlsing:
`(:1)
`-Z§l.’3'l£’;lI‘il,l’lg a "fetal Elllfl maternal s:e.ll—l‘ree genomis: EBNA sanipile l'l‘f3l’l’i, easzh of the pl‘ui'al:lt§,« of
`niaterna blood sainples;
`
`selectively enriclinag a plurality of ’(‘Ii'}Fi~1"§il'l£l0E”!‘l polytaucleotlcle '~‘«f5:;’{llti5l’tC'c‘,.‘~‘. of each l'etal anti
`(li)
`inaterna ::ell—free genomic DNA sample cf (:17; to generate a library clerived from each fetal and
`maternai s:ell.—l7ree genoinie l) N/-‘X samgstle -;t‘em'lcl1et'l and indexecl fetal and maternal non—_rant‘lom
`polyn1n;,er_itide seqiienees. Wl'1€‘:“€:l_l‘3
`each l.il:ra.ry el"el1ricl1.et'l and in:'lex.ecl _i'feta.l
`£1.1‘.‘=.Cl niaterr::.a.l 1'10!!-
`l“c1l‘;t.l0H1 polyr1ti<:leotia‘;le sequeliees inclutles an lli&‘.lt'.’.}§ll1_g ilueleoticle sequence Wl1l~‘.<.?l1 idenllfles. a
`matema blood sainple of the E.'Jl'L1l'fllfll.'_'y’ of maternal blood samples,
`‘v'v’l.‘:€:‘.J,'¢':‘ll’1 sa.itl plurality of Uf3tl~l"fil’l(_l0£‘)‘l p<.>l.ym.icleotlcle se::gi;er:=.c;es £‘f.>l?3"t{)l,‘_l.S€:?S at least lllll al,ifferel1'r.
`non--i'ane:l=3m p-olyniicleotlile ,‘;€'3ql.l('I‘.ll£.‘<'):'~; selected. from a first chi'omoson1e tested for being
`aneuplofl and at least l Oil diflferent J'lOll—l‘2lU=‘.'l0lTl pol}/nuszileotlcle sequences selected tiom a
`l’¢'.‘,lC{’.l'€_’.ll-I.?(') cl *omosorne. wherein tlie first el‘:romosot"ne tesateal for being aneuploitl and the
`referen»:<e elnomosoine are different, and VVl‘lCl'Cll"; each of said plurality of non--random
`polsynuc eotlcle sequences is front ll) to lllllll 1'mc:l.e:':tiale bases in lei1gtl:..
`
`pooling the lilxraries generalecl in (la) to produce a pool of et’it“lCl‘3<’:€.l and im'le>ceal fetal arlcl
`(Ce)
`maternal nc>n--ranaloni pa:-lynussleotiele sequences;
`
`perfonning ma.<;siVely parallel sequensziiig of the pool of C‘-i‘tl‘lCl1=3iZl and indexed fetal and
`(cl)
`maternal norrrantlom p='.')lfft1lCl€Ol.l('lf§
`sequencesi of’ (Q) to procliice érlffq‘-.l€3liCi‘: reads c:orrespo:'1ditag
`to -:2i11*icheal and indexed fetal and inaternal 11011-1‘El11(l-3111 prilylni-2leotitle_% sequeriees of each of the
`at least lllll dillerent non-randoni poilymlcfleotide sequences selected l"_r-an‘; the l'lr.~;t eliromosome
`tested for being anetiploitl anal sequence rea<.ls coire5pond.ing to eriiiched and l11tl¢:xe.cl fetal and
`
`IPR2013-00276
`Ariosa Exhibit 1053, pg. 4
`
`

`

`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 4
`
`maternal rxmrrzmdem px:>iy‘ra‘uc§e0iEde sequeraceza of earth 0?" the {it Eezmt 100 ¢’}i{"fe1‘en=; n0n—r;md{m':
`po1y1‘rue]e01'ide s.equenr;e9 seiezsted from the refer:‘:m:e c;hr<>rr:0some;
`
`'::.e<;;uenee, for each of the plurality of maternal bleed
`based on the iradexing zaudeotide.
`(cf)
`samples, enumerathig Sr3qm31’,a-‘.:€'
`reaxzis; ccsrmspohditrg to enriched and indexed fetal and maharhzai
`ram1~r:mdm‘n p01ym:c}.eL':tide Se-rgumcses seieeierl
`fmm.
`the firs‘:
`C}.":1‘=‘.)T_'{‘iOS(.7J'E'1E:
`testecl
`fz'3:"bei_hg
`aneupioid Szlld aeque-_°.11c:e reads correaperldirag teehri<.:11e.d and irrdeamd fetal and n1ater'11L.1 11en—
`rzrndmra p01‘_‘,’f1ElC},t'£i‘§1'id8 sequences selected from the referem';e Ch!°0f1’lOS»‘:,tU'18; and
`
`far each of the reiuraiity <i»’i"1:nate1‘m'aE blood samples, mteryninirig the presence -::~r zalwsenee of
`eff)
`a fetal a11e:.up':0id§: comprising using a 11L1n1be1* of enumerz=.te.-Li seque.11<:.e rezzds eo1*re9.pc-11:.fi11g to
`the first ehromesomre. and 3. number of enumerated sequensse reads sscsrrespondin to the refer-er:<:e
`c}'1mm0s_+c>a‘ne of (6:1).
`
`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. Patent Pub. App. No. 2{I=L=6;'0l2E4:32 to E}}'1:1}E;m H (hereiniafter “‘E}haEEan H“) (}?.:x‘h.
`
`Crzaig et 2:}. Nat. Methods. .‘§{} {l!):€<i€<Z7—9I3
`
`(j2{)0é‘3) ifihereiiaafter “‘{Iraig”) (Exh. F and Q}.
`
`Q5011-a.;~; Bihladera er. 211., PLUS ONE. 2937; 2(2): e197 {hereirrafter “Bi11iadeh""; (Exh. D).
`
`I§1ur:‘1ihzL§3r0ehL:re “I\xIL11tip}exed Sequerreihg with the Hiurnirra Genome Analyzer System” (_”2=I'.308j
`5.
`(hereir1z:i’Lez' “IiEu‘mir.4a 2iIPi§S”V) (Exh. G).
`
`»-.
`P2fi”£1.1’1’)<’:S‘J\.’§i!“?iF1, est 513., Nucleic Acids. R.es.c:a_rc}:¢ 4150 9);z=:33O (.2007) ( ‘m=:rei1‘1:1f,‘t,-.=:r
`
`6.
`
`'“‘Parameswa;'2m"’) (Exh. H and S).
`
`E-1a:‘r;.ady, fit 2.21., Nat. Mt':t}mais, 5(_fi3}:23§~37 (3.008) (3‘1<_%r<.?ine;>a{"1'cr “I§ -iamazig/”) { 1).
`
`US. Patent Pub. App. Na). 2-()G8f0(}9{}239 to Shoemaker, et al. (hereinafter ‘“Simenmke;"’)
`
`€E::h.
`
`J).
`
`E3ha3Ezm I (iiixh. {.7} and Binizaderi were used in the inter Pzmes ReV‘ie\;vs 2(}3,3—=II={)27{rI arid
`
`002774 The grc-und considered in the {PR involved Shoemaker‘ as primary reference and Dhalizm
`
`IPR2013-00276
`Ariosa Exhibit 1053, pg. 5
`
`

`

`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 5
`
`I and Binlaaien were used as secondarj,»‘ ret"er'en<:es. E*£owex'e:f. no final dezsisiorx was issued in
`
`these EPRS. Further‘, Dhalian ii is mesented in a new light in View -zsffiinladen in this request.
`
`liiumiraa. 2098 €:i:.3(i3. G) was used in the appiiacation t.E':a.t resulted in the pmseiit ‘43€l
`
`paterfi. E-iowe*«.«‘e_z‘, in this reqirest, Hiumina ZCHLJE is used in a new light in corjnbination with other
`F«3’iCt31‘€l1C€S.
`
`Dhallan II, Craig, Parameswaran and Hamady were neither cited nor used to reject the
`claims in the application that resulted in the present ‘430 patent.
`
`Sihoeriialzer‘ tiiixh. J) was not used to raise SNQ in this Request.
`
`Additional Documents/Exhibits
`
`The Request and the Information Disclosure Statement filed on 1/8/16 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 2258).
`
`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
`
`IPR2013-00276
`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
`l .
`the ‘430 patent is raised by Dhallan II (Exh. E), Craig (Exh. F) and Illumina 2008 (Exh. G)
`(Request pages 31-34 and 39-64).
`
`Dlmllatt ll describes obtainirtg blood samples from rhu.ltiple pregnant wontert, isolating
`
`CL'L’:ll~'l‘1"€.’.f: DNA _t'_tom ‘th.-we sa.r:=::ples, meth<.>tis for .'trrtplit’ie2ttion (iselective en_t‘i<:l'tt r1et1t} of non-
`
`random pa-Eyittteieotittes for the piturality of mztterraal sampies [t)t'){€()j and [()E27}, detecting the
`
`non-rzmdmta poE;v'ntteleotit’ie.==. for :1 §3l1Jt‘21ll‘f.f,«‘ of maternal satrtples, ertumerating (cotttitingl alleles
`
`at loci of interest, and comparing ratios of alleies at the enriched (9. airapiifietil no-h--:“at1a:iort1
`
`p€_7l}711t1-;Tl€0'(lLli’.S
`
`to determine a eltromosomal abrtormality inttltxttiitg a fetal aneuploidy [GUI-E7 and
`
`ililiilifi. ‘t/'ztr°i-otts mrczthods are disc}-osed to detect the sequence of ztlleles {=II=22;‘3, (it)-$6}.
`
`Craig describes it pcrlyrrticleotide detector technique using l3fi1‘t.‘C:£l£’(,l (“ii1<;lexed"')
`
`tnultipiexedl Sequencing ot'sele::1'eti nucleic :1<:il-sis from ciit"£"e;‘et:t human rhdtivil-;'§‘:.1;tls. Crzlig
`
`diseiioses that the S£‘tE’,‘{J,f-E6‘. sequences from different individuals were initially arnphfied and
`
`pt_3t_>lt:t'i prior to the hgation. of the l7areoé,es (indexes) {page 2 in .E.xper_'ut_1etttal tiesigtz. and
`
`Methods in page 6}. Craig, attached the sample inclexes tllisted in 'l"a‘L7-Ee 3) to the selected. nucleic;
`
`aeizls by hgatioo (_A.t3st:':tet'. Fig‘-.11t*e I zthd page 2} A't‘ter ligati<_m,, the satnples from all imfividuals
`
`were pooled into at single sarhpie {referretl to as istdexeei lihr2tt';v'). purified. enriched by P€.‘.R arm}
`
`seqtreii-red on the llluntina GA (page 2). Once the «copies of the selected nucleic acids were.
`
`seq ueneeei, the seqttehces ofseleete-:1 huezlehz acids front each sennple couid be gr-ottped by virtue
`
`of the santple index for further attalysis {that is, the S~f.’.qtlt311t’_?E):€ were “tiet%o11voluted"’ into .~;a1nple-
`
`specific bins).
`
`llllitlllila 2€.)O8 discloses; that 2: {Scheme Analyzer l»:it is available to lTiEtl~:('. multiplexed
`
`secguetxeing. zmd ata.tes that the multiplexed sequettcing is faster and Chfia per than t1‘2tdit'iona}.
`
`massively paraliel sequencing. in the multiplexed seqtienein ntethcscl, DNA lihrztries are
`
`“t,agged°‘ with imique i-:ient,ifie1'orindex? during sathpie ptepara.tiorL Multiple sa.r;::ples are then
`
`po-:,~Eed into L1 zrirtgle lane on 2; flow ceil and ‘then sequenced together in one ilerttmxe Anal_§;;aer
`tun.
`
`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.
`
`IPR2013-00276
`Ariosa Exhibit 1053, pg. 7
`
`

`

`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Accordingly, the combined teachings of the Dhallan ll, Craig and lllumina 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*arameswar2.n utilized sample indexes ('i.e., “ha:'eodcs“’:) in conjunction with high-
`
`E.l1J,'011gl’1p1l‘l, pyroseque:‘1cir1sg on he £3320 Sequen<:er (4-S4/Rocl'1e’) to simultaneously sequence
`
`nue.t1ei<.< acid lihraries from inclepenclmat sets of 25 barcoded. libraries. Pa1‘ameswara11 added tlie
`
`ha.rco<'le:e1 to the nucleic acids of ir:=.te_test' by irxoluding the l_aar<:<_>des in the p_ri_tners used to ’<‘3.l‘)‘E{.‘9ll,l‘)’
`
`the nucleic acids of €nte.res=.'.
`
`I_.lsi‘:l1g the bar<:«3d3ng, technisque, Parameswaran et al. report that their
`
`pyrosequ-211ci11g l3=2i1‘£.3f,3£.lé.’,a’.l approach allowetl for the unambiguous L-.ssignment of nucleic acid
`
`St3Cp.Et’:fi=‘3t‘.~3‘ from a mixture of lit;-r2u‘ies from up to 48 dit”t}3_rea3t samples {page
`
`Hztmady teaches ei‘1't.>r--correcting DNA barxcodes that allow one run of a ntassively
`
`parallel pyrosteqtiencei‘ to process up to 3,544 samples simulumeotisly (_Ahs.tra.oL). E-lz'3.rt:a-'35,’
`
`zriems:-nstrzates that the use of the sample inclexes with the Rc+che;’454 massively parallel
`
`sequencistg system would lmve had sut‘t‘§c.iet.1taietesxtigm €:1'.i'.lCl,f:1‘}.CJ‘¢v.’
`
`it) allow (.1-.€T?f,£,‘F.l,';'3E'1 of the
`
`p1‘€'StI‘1‘1t2E‘ or ahsetice of fetal aneuploidy in multiple matrzrnal samples analyzed simultaneously.
`
`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 ll, 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
`
`IPR2013-00276
`Ariosa Exhibit 1053, pg. 8
`
`

`

`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`Page 8
`
`21, trisomy l3, trisomy 14, trisomy 15, trisomy 16, trisomy l8 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. 3l, 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 ZOTM 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 GS20 can be applied to PCR-based
`
`assays of multiple homologous PCR products (Abstract).
`
`The combination of Dliallxan l and l':§inlad.en f-msentecl herein i'Cll€‘.S on the
`
`sequemsmg techniques of Efiliallan {being replaced by those described in _8_inl.a<’ien (rf.s:.,
`
`niuitiplexed massively parallel seqtiencing). 'l‘hi;~; particular confsinatiaon -of Dhallan] and
`
`Binladen was not ::<.>nsidere-Li clearing the exa.rn,ina‘tior1. of the applicati.<_m or in other proeeeclings,
`
`The ground considered in the lPl1'. involved E§boemal<er‘s sequencing techniques being.
`
`rnodifieai only to include the use of e::t1*ace.llnlar DNA ffroni Dliallan I) and multiplexiltzg
`
`samples from ineultipie patients {from Biniladen). /—‘lecoi‘dingEy, the :3-;‘,~r1'rl3ina‘1i.r3r1 -of l)h-allari l and
`
`Binl-L-.den provides a technical teacliiiig which was missing from the applied prior .:u‘t.
`
`There is a substantial likelihood that a reasonable examiner would consider these
`
`teachings important in deciding whether or not claims l-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
`
`IPR2013-00276
`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)-(j), 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 C.F.R. 1.530 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 Ponnaluri 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).
`
`IPR2013-00276
`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
`
`lattps://efs.uspto.gev/efile/inyportal/efs—-registered
`
`By Mail to:
`
`Attn: Mail Stop “Ex Parte Reexam”
`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. Witz/
`
`Supervisory Central Reexamination Specialist
`CRU -3991
`
`IPR2013-00276
`Ariosa Exhibit 1053, pg. 11
`
`

`

`Application/Control Number: 90/013,678
`Art Unit: 3991
`
`IPR2013-00276
`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 PTO-892,
`
`b)EI PTO/SB/O8,
`
`c)|:I Other:
`
`1. IZI 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 Ponnaluril
`
`Patent Reexamination Specialist
`CRU 3991
`
`if third party reguester I
`cc:Reguester I
`U S Patent and Trademark Office
`PTOL-471G(Rev. O1-13)
`
`Office Action in Ex Pane Reexamination
`
`Part of Paper No. 20160126
`
`IPR2013-00276
`Ariosa Exhibit 1053, pg. 13
`
`