PATENT COOPERATION TREATY
`
`From the
`INTERNATIONAL SEARCHING AUTHORITY
`
`To: BENJAMIN D. CASHDOLLAR
`PERKINS COIE LLP
`P.O. BOX 1247
`SEATTLE, WA 98111-1247
`
`§--i~R~~NS t)tJ~~ tl,J~
`
`Appfo:ant's or &gent's file n:ference
`i 11552~8033WO00
`fotermstiomsl applic&fam No,
`PCT/US 23/60927
`
`i Intemationrtl filing dare (daylmonthlyrtar)
`I 19 January 2023 (19.01.2023)
`:
`Intem:s.t1m:m! P:s.tent Cl:s.ssHi.ciifam (IPC) or lmili natiomsl classifi,;mtion and IPC
`. !NV. A6iM 25/18, A61M 39/10 (2023,01)
`!PC
`ADD,
`
`PCT
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SE.ARCHING AUTHO.RlTY
`
`(PCT Rule 43bis.1)
`
`Date of m&iling
`(doylrnonthl,i;;;or)
`
`I~ ~ ~ 2 (}
`
`~~ ,❖ ~'-'
`
`'
`
`FOR FURTHER ACTION
`See pisrn:grnph 2 bek1w
`
`Priority date (dq)lmontht)~)
`08 February 2022 (08.02.2022)
`
`..............................
`
`CPC "
`
`INV, A61 M 25/0097, A61 M 39/1011
`
`ADD.
`Applicant !NARI MEDICAL, lNC.
`
`Bas:s ofthe opinion
`
`n L __ .J Box No, m Nmi-establishment of opfoi,m wit¾ rngru-d to novesliy, inventive step and ifldustrhiJ applio::ability
`[X1 Box No, !V Lack of unity of invention
`rxl Box No, V
`Reasoned statement under Rule 43M,d(a}(i) whh regru-d ID novelly, inventive step &nd industrial appfo,ability;
`c1tafamr, and explanatlmw supporting 8uch gtatement
`□
`□
`□
`
`Box No, VI Certain documents ciwd
`
`2, FURTHER ACTION
`U' t\ drrn~nd ~Or ink:·~~i1;stfrJn:1! pt~1frnb·mt)' :...:~Rn1.in~tkn~ ~~ n·m.&i~.: thi:i opitSk~n ~,.~:~H h~ t:cs~n:sh.1ef~rl ts:l hr & "'"'1'it!t~rs t1pinfrln tsf ihe
`lnt~nnatk:rmJ Pre! ~fJ~ina:-y E~J~nlnh~g 1\i~th~~·~ty f' .. [PEl\ ::~) exc~'!pt thS;t this doe~ ~1~t ;~pp~y ·\~•he.r~~ the: appH~t&nt choo~~ an i~:uthortty
`s.::th::sr th~tn this n:;1~ t~i b~ the H?E~4. ~nd the cht-::ss..:n gpEl:i .. h~s notified ihe h.1t~ET:.~tk-:n~i Httr~:i:-s undtr Rt~fo 6ti, l&~i.t(b) ifafil \.'~nHi~n
`opin1m1s of this Intemational Se!lrching Authority will not be so considered,
`lfth~s oph1io~ is~;.,~ pr(3Vif~~rl ab~3V~~ con~idered to ht! r~ \~•Jk::t~~1 t3p~nk1~1 ufthe IPE,A~ the &RPH~~nt is: fr:v~t~d to ~t~btnit to the; JPE~.:\
`~ i~ · :d , : i l - :J i . r~p~y t~..-:~~ethcr~ i~ ·h , - :_n~ ;s ,ppn . .-rpf~tt~t~ ~NH t ~~nt:~dn.1{:·iiti~ b~ f ! } ; '~ th~ {::,-.:;:pSra~]on ~ ) f3 ~ i1on . th~ , ; ii"o~r:. tht d~~tt ~tf~1m,Hfrig t~fF'ot~n
`PCT.i!SA.i220 t;r }mft1t~ th~ t~~piniHon ~~f J2. n1t1n~}m t1~~}}11 sh::;'! prk;rity date~ i¥hiche\•·er e~ph'ts 1;tter.
`For forther opt1ons, see Form PCT/ISA/2:W,
`
`I Authorl~ed officer
`Imperative Care v. Inari Medical
`U.S. Patent 11,974,910
`Imperative Care Ex. 1002
`
`PCT Halp Dasi;
`\ Telephone No. 5?1-2724300
`
`K<1r! Roddqt.J~z
`
`, 1,
`
`
`
`N&me and m&l!ing address of the 1SN!JS Do1te of completion ofthill opinion
`Mail Slop PCT, Attn: ISAiUS
`Ccmm\&slormr for P3ie~ts
`P,0. Bm,; 145tl, f\laxsr.drls, Virginia 2;t313-1450
`Facsimile Na, 5?1-273-8300
`Form PCT/1SA!237 (cover she;st) {revised J\J!y 2022)
`
`12 April 2023 (12.04.2023)
`
`-576-
`
`

`

`WIDTTEN OPINION OF THE
`INTERNATIONAL SEARCIDNG AUTHORITY
`
`• fo.ternatimm.1 appHcation No.
`
`PCT/US 23/60927
`
`1. With regard to the l:rnguasge, this opinion has been esta.bliahed on the basis of:
`Ll:g• the international application ln the language in whfoh it wa.~ filed.
`D !l. tmn:slafam of the interrmtimml application iiito -----------------------"--·-- which is the la,."lgu;i.ge ofa translation
`
`famished forth" purposes of intern!ltional search (Rul1J:1 12.3(a) imd 2'.U (b)).
`
`2.. D This opinion him been established taking into m:eount the n)etlfie11ti,m of 1111 11bvfous mist:ike authorized by or notified to
`
`thi;; Aufoori!y under Rule 9! (Rule 43bk l(b)).
`
`Wi!h reg<!rd to any imele!!tlne <!ndfoi- arnim, add ~eque11ee disdolJed in the international applii:ation, this opinion h!l.'l been
`established on the basis of a sequence listing:
`
`a. D forming part of the international llpp!lmitkm as filed.
`b. 0 fornfohed subseq_mm, to the intema.tlona.! filing date for the pUl"poses ofintematkmal ae&rch (Rule l3terJ(a)),
`D aeeompnnkd by a. 81,}Jcm(;)nt to the effect that the seq1ience listing doea not go beyond the dladar,;ure in
`
`the ,ntcrnistfona.l a)?µ!watlon aa filed.
`
`\Slith n~g;~n .. i to an_y ntml~~;tide .i~1ctA1r a.{nino at:Jd s.~quer:t.-:e. d~s.c{o~~d in the intern~ti~;n~l app!ic£Ssion~ th.ls op~nk~u b~:s t~~':~n
`e,tablisht:d t~ H°tf ~~ttnt that a. ~~1!:~S1ingirl! l)p•inK1i1 Cl)t~ki bi~ :fon)"'S;crl \~iiht~tit a. \V1P() St!irldard ::rr~:1.6 t:(}sn11Hant ~tqt~tEt€e
`Hating.
`
`:i. Add1tkmal comments:
`
`-577-
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTI-IORJTY
`
`1ntemationa! applkatkm No,
`
`PCT/US 23/$0927
`
`Bo:1<: No. IV
`
`Las:k of unity of inv.:aitiol'l
`
`l, [XI In re$ponse to the invitntkm (Form J'CT/lSAJW6) to pny additional. fue;; the applicant has, witbio fue applicable time Hmi.t:
`D paid addit:oml1 foes.
`C paid addi!ioms1 fee!l under protest and, where app!it:able, the protest foe.
`D paid add1tfonal fees under protest but the applicable protest fee was not paid,
`!Z] not p11id additional fees,
`2, D Thi!l Authority found that the requirement ofimity ofinvention is not complied with and chose not to invite the applicant to
`
`pay additional fees,
`
`3. This Authority con~idern that the requirement ofuoizy ofi1Jvention in accordance with Rule B, 1, 132 imd 13.3 is
`
`D complied with.
`!Z] not complied with for the followfog reasons:
`
`Thi!l lllpp!icatlon cor:tairns tl'1e fo!lowi1:g inventlorns or growps of inventiona which are not !lo !inked ais to form a single genera! inventive
`concept 1.mder PCT Rule 13. 1. In order for al! inventions to be searched. the <1ppmpri::1te .iddltlonal search foes must be peild.
`
`Group I: Claims 1-13 directed to a cap assembly for a cathetar.
`
`The inventions listed as Group& HI do not relate to a sing le general hwentlve concept under PCT Rule i :I, 1 becarnie, under PCT Rule
`132, they leek Hie same or corraspm1ding special technical features for tlle following reasons:
`
`SPECIAL TECHNICAi. FEATURES
`
`The Invention of Group I Includes the special technical features of (a tlrst cap Including a locldng member), wherein [the locking member)
`Includes a11 and portion and [a tab) positioned proximate the end portion; and [a sacond cap including a locking feature], wherein the
`kicking fsature lnc!udes a slot e)(temling at least partially through [the second cap), in [the locked pos!Uon), [the locking featwre is
`conl1gurad to rece,ve tt1e locking member] tl'1mugt1 the idot [such thlllt tl'ie tab engages l3I portion of the second cap] to inhibit movement of
`the [t1rnt cap] relatl11e tc !the second cap], rmt required In Growp II.
`
`The irwantion of Gmwp II inc:udes the spaclal technlcal features of a vascular accass system, comprising: a valve having a proximal end
`and a distal end: a catheter defining a lumen and coupled to !he diata! end of the valve, the catheter defining a longitwdlnal axia of the
`vascw!ar acces,s, syl3tem; l3 dilator configured to extend at !east partlB!!y through me vs:alve ,md the lumen; wherein [me cap l3l3l3emb!y]
`Includes (I) !a] valve !cap] connected to the proximal end of the 11al11e and pncludlng 2 coupling feature], and (ii) [a] dl!Btor (cap) cowpled to
`U:e di:ator r:ind (Including aJ coupling mb lmmrtab!e Into the coupling feature], wherein [in the locked configuration, the coupling feature il3
`configurad to receive the cm.ip:lng tab swch tllat the coupling tab engages a portion of the) valva [cap) to inhibit mooament of tha dilator
`relative to the velve along tt1e longltudirml axis, not raquired in Group L
`
`4.
`
`Consequently, th!s opinion has been established in respect of the following parts ofthe internatlorn,l application:
`
`D S!l!pS!rts,
`lZ] the parts relating to claims Nos, _1_-1_3 ______________________________ ~
`
`-578-
`
`

`

`WRITTEN OPINION OP THE
`Il\ffERNATlONAL SEARCHlNG AUTHORITY
`
`i Intematiomi.l application No.
`1 PCT/US 23/60927
`
`Reasomed $fatiemfnt s.mder Rufo 4lbfa.l(a)(i) with riegara t!I Mvdty, inventivf $tep and indu$!ria! ::applicability;
`citathuss and cxp!anathms supporting such statl':mt1nt
`
`Claims
`Claims
`
`Claim§
`Claims
`
`Claims
`
`Claims
`
`H2
`
`None
`i-13
`
`None
`
`fodustrfa! applicability (IA)
`
`YES
`NO
`
`YES
`NO
`
`YES
`NO
`
`2. Citations and cxplanatkms;
`Claims i~2, 5, and 7-ii lack novelty under PCT Artlcle 33(2} aa being an!ioipated by CN 106178227 A to Shanghai Mioroport Medb,I
`Group Co .. Ltd. (hereinaftsa, 'Shanghai').
`
`Regarding clalm i, Sh,mghEi teaches a cap assembly for a catheter (devlce that locks and unlocks catheter sheaths and dilators,
`Abstract, Fifl 4; Note: all Cltatim1s !o Shanghai are to the translation of Shanghai), the cap mrnembly comprising:
`a lirat mp (dilator !Seat 1, Flg. 4, pg. i 1} includlrig a locklrig member (claw buckle 9, Fig. 4, pg. 12}, wherein the k,cklng member includes
`an end pcrtlon (distal iind portion of o3rm of claw buoklii 9, Fig. 4) and o3 iab poaitionm:! proxlmat., the iind portion (distal to3b eldendlng from
`a distal end of lhe a,m of claw buckle f::1, Fig, 4); and
`a secor.d cap (sheath seat 5, Fi!l 4, pg. i 1) including a locking feature (recess in seat 5 fur receiving claw buckle 9, Fig, 4, pg, 12),
`wherein tt1e locking feature indudes a !Slot extending at least partially !hrough the second cap (Flg, 4), o3nd wherein ....
`ttm first cap Is confagur.,d to be &!loured !c th., i,econd cap in a locked position (push clo3w buckle 9 Into sheath semt 5 to achieve
`locking, pg. 11 ), In the locked position, the locking feature Is contigtired to recelw the locking member through the slot such that lhe tab
`engages e portion ot the second cap to Inhibit movement ot the iirnt esp relative to the imcond cap (claw buckle 9 and irwerted buckle 10
`,.map to achieve locking, Fig, 6, pg. 11), and
`!he llm! cap is configured !c rotate relatlve to the seoond cap to move !he tab ou! of engagement with the seoond i:;ap to move the first
`cap from the locked position to o3n unlocked possl!lon (during th., sepam!ion process, turn dllo3tor seat 1 clockwise or oounterclockw!s., i,o
`lhat it Ir:; separated from the sheath ooat 5 until the claw buckle 9 is detached from !he inverted buckle 10, Fig. 9, pg. 12).
`
`Regarding clalm 2, Shanghai teaches the cap assembly of claim i wherein the first cap Includes an upper smtace (upper surface of dilator
`aeo3! i, Fig. 4), arid wheriiln thii locking membiir !lJdiinda from the upper ssurfaro In a direction geri!lraUy perpendicular to the upper surfai:;ii
`(Fig. 4), o3nd whiireir; !he !lnd portion of the locking membiir la oppoait<l !he upper m.irfaoii (Fig. 4).
`
`Regarding claim 5, Shanghai teaches the cap assembly of claim 1 wherein the locking member ls flexible (claw buckle 9 can move axial!y
`and elastically defarm radially inward, Fig, 4, pg, 12). and wherein the second cap ls configured to bend the locking member when the firnt
`C!lp moveis betweer. the unlocked po!litior. and the locked position (buckle 1 {l of sheath seat 5 !o deform !he claw buckle 9, Flgs. 4, 9, 6,
`pg. 11).
`
`Regarding claim 7, Shanghai teaches the cap assembly of claim 1 wherein the locking feature includes an angled insertion surface
`(angled upper surface of buckle 10, Fig. 4) positioned to engage and deflect !he locking member when the first cap rw:.wes tram the
`unlocked position icwo3rd !he looked posl!icn (Fig. 4: claw buckle 9 can move o3Xlo3lly and elo3stically deform radially inward, pg. i 1;
`intended use, the angled upper surface of buckle 10 can elastically defurm the btick!e 9 inward for locking).
`
`Regarding claim 8, Sha:1ghai teaches the cap o3ssembly of claim 7 wherein the cap assembly ini:;ludes a longitudinal axis (Fig. 4). o3nd
`where the Insertion surface is ang:e'-1 to bend the locking member inward toward the longitudinal aids (Fig. 4, pg. 11}.
`
`Regarding claim 8, st1anghai teaches the cap !lissembly of claim i wherein the locking feature Includes a mdial removal surfeoo (lower
`ar;glsad surface of buckls 10, Fig. 4), and whemln ths radi<il removal surface is angled to det1act the tab inward when !he first cap is rotated
`,eiative to the second cap (Fig. 4: claw buckle f::1 can move axially and elastica!ly deform radially inward, pg, 11; daw Sis detached from
`!he inverted buckie 10 for separation. pg, 12; Intended use, !he angled lower surface of buckle 10 can eiasUca!!y deform the buckle 9
`inward for un!ocklrig}.
`
`Regarding clalm 10, Shanghai teaches the cap assembly of claim 1 wherein the locking fueture lncludes an ai,;ial removal surface
`po!litioned proxlma!e tt;e s!ot (lower angled !lUrf!lce of buckle 10 proximate to !he recess ln at1eath iseat 5, Flg, 4) and angled to move the
`first cap mNay from the second cap when !he firs! cap is rotatiid relo3tlve to the second cap (Fig. 4; claw buckle 9 i:;an movii o3Xlally and
`alm,tlcally deform radially inward, pg, 11; claw 9 is ds!achad from ths Inverted buckle 10 fur sep<!ratlon, pg. 12; intended ame. thsa angled
`lower surface of buck!e 10 can elestfca!!y deform the buckle 9 inward for unlocking).
`
`-579-
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`fotemational application No.
`
`PCT/US 23160927
`
`Supphems.mta1I Box
`;--------------------------------------------------········
`fo cmie thse ~p111ce in 11111.y of thse pi-ecedil'!g boxie11 is 1mt sufficient.
`Contim.1ation of:
`-•-Baj( No. IV.J - LBck of ,mity-•-
`
`COMMON TECHNICAL FEATURES
`
`Tim lnventlm1s of Groups; HI :lh!llm the !echnlcal feBtures of s c!llp sm,embly, the esp aimembly includlng fimt esp including a ioeklng
`member, where:n the locking member includes a tab, and a second r;;ap including a locking feature, wherein the cap assembly is movable
`between a locked configuration end an unlocked configuration, wherein in the locked configuration, the locking feature is configured to
`receive ihe locking member such that !he telb engages el portion of !he seoond cap to inhibit movement, and the lirnt cap is configured to
`rotate relative !o the second cap !o move the tab out of engagement with the second cap to move the first cap from Um locked poisi!lon lo
`!lln 1.mlccked position. The commcn ti'lchnical foetums !life known In prior Br! BS simwn in US i.i,~'!91. i 52 A to Petterncn {heralnsfter
`'P!lltterson'), Therefore, Grotips 1-11 leek unity since the sh1:1rnd technim,I features do not represent 1:1 contribution mmr:
`
`Peliternor. teelches a cap elisisembly (hubis of catheter assembly complemeniel)' elnd rotatably engelgeable, Abstract, Figs. 7-9), the i:;ap
`aisisembly lndwdir.g:
`a first cap (hub 2.5, Fig. 7, cot 5, In 24-29) Including a locking member (locking member deftned by tirnt tab 29, Fig. 7, col. 5, In 29-34 ),
`wherein the locking member fnciudes a tab (pin 100 axially disposed on distal end offlrsttab 29, Fig. 7, col. 5, In 29--31). and
`e second cap (hub 35, Fig. 7•9, coL 5, In 24-29) inciwdlng a locking f!letum {locking element of hub 35 Including tlrst projection 150 and
`first eslot i05, Flg. 7-9, coL 5, In. 3'!"34),
`wherein ihe csip mmembly is movable between a locked configuration amJ an unloci<ed contlguratlon (d!!ator hub 25 ,md introducer hub
`35 are mleasably interlocked, col. 5, In 24-29),
`wherein in the locked cor;f;guration, the locking feature Is configured to receive the locking member (mechenlcai!y Interlocked by insertlng
`wb 29 with pin 100 into enlarged open end of slat 105, i::ol. 5, in 45-49) such that ihe tab engages el portion of !he second cap io inhibit
`mmmmer:t (once tab 29 with pin mo us engaged with &lot 105, mdal disengagement ls precluded by projection 150, cot 5, In 50-55), ,md
`where!n the first cap is configured ta rotate relative to the second cap to mmm the mb out of engagement with the seoond cap to move
`the f:rst cap from the locked position to an unlocked position (dilator hub 25 and introducer hub 35 are releasably interlocked to provide
`resistance to rotational dlsengagement, cot 5, In 24--29; resistance posed by interfering portions of slot 105 inhibits accidental ro!ational
`disengagemen! [:n the apposite circumferen!ial diredlonl, i:;ol. 5, in 53--55, coL 4, In 42-46; unlocked position, Fig. 7; implicitly, hub!! 25 and
`35 car. be lntent!onaily ro!ated In the opposlie circumferential direction to overoome the resistance posed and to ro!eaise the interlock},
`
`As the common features were known In !he mt a! !he t!me of the lnven!lon, they cannot l:le considered specie! technical features that wot1ld
`o!hefWlss unify the groups.
`
`Therefore, Gmups HI lack unity umfor PCT Rule 13 because they do not share a ,mme or corresponding special techniCBI feature,
`
`-580-
`
`

`

`'\-VRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AlITHOlUTV
`
`foternsfoirn,l applicatiM No.
`
`PCT/US 23/6tX:!27
`
`In case tile splice in :u1y of thee preeedillg bol'.e~ i~ llot suffidce&it
`Car;tinuatiar; of:
`'"•~Box No. V.2 - Ci!atio,m and expl1>nafa:mes-•-
`
`F{agard~ng ~~a~rr; 1 i, t)hi~ngh;~J t&i3t.11es thi~ Qap i~iS$~~11tl~Y r:sf c~ah't1 ·; \:-Jhere~n:
`th~ firs;t ti:ESP lnt:h.idi:3S ~·H; t~ppar &t1~fac:~ (l,ap~r &:tut~1~rs t.JiS t".m~1it.sr s{:1;:~t ·1: F;fs.• .-t) .. ar!d fi)~1 k;t~~~nrJ nli:S~r:b~r ~~xtt~nd::s §).··.:m~ th~ upper surf;::H;a in
`~ c::.:s<.E<tn ~t•¥~ .. <~t)Jk:t.::~1~ to ~h,~ Hp;..t,2:? t,;tJSt~..z .. ,t::., (r\s.- e~)~
`tMi~ ~otklng rn~~~:h~~r ~s ?1i~~b~i~ (df3"-~ bt~~~~ i) t~~r~ n1ov* B~iBt~y ~~~'1d ~~ist~t~~;~f d~ixr::1 r!:lctla~t~l ln\-Vf3R~: r:~g. -~- pg. i :<_} and t~'1fitjur~d k.~
`di:?nect \.Vhen ~he first c~1p n~ove~ b$f-..;,•li~er: !he tsnit~t.~~~ p!~$i~on ~it1d th!! !iJ~~ed pQs~tk:n {bl:c~de 'itl ofsh~aih seat 5 Ao di3~rrri the rJa\~
`tn.:cJ~{~ ll. Figs;,-$, t1 .. 6~ p~. 1 i l:
`the tab de!imis ;s rsialning Eu1faoe {n~ce:5':5' defined be!wser: diet1>I !ab of cl.iw b-idde .ind mm of claw buc~le, Fig. 4) per.mimed to co:-i!isci
`.i! least .s porfa:;n i:if !he esecorn:l c;sp in !he !oe::km:! poesili!:ln {poslUomsd io con!ac! !i'Sl-',m, angled smfuice !:If brn-::k!e 1 O in locked poesltlon, Fig.
`6); am!
`H1~ ~.c-c~:~nn ~~**' •r* l,>f!~ '\i~s, ..... -
`a locking surface pm,,Homsd lo ai least pisr!!ally mn!act !he mielning l.urfss.,~ of !he tab In !he locked position (pmjeclion oi buckle to
`wn!isc! rm::eEes of c!aw buckle in locked position. Fig. 6),
`1im irmm\ion m.iffsce {,mg!ed upper srnf;:ice cf bl,e::kle ·10, Fig, 4} po:,ilionoo w be s! l;si;:i&! part!.si!y .s!lgn;sid w!!h ihe !oi::king mwnber (Fig.
`4) and sngled !c deflm~t !he locking membis,r lfll,'-1.Srd whim \his, f:rnt c.sp mrivis,s wom the w,!t,e::ksd posrnon \O','\.'S,d !he lm:l-led poolii,.,n {Fig. 4;
`c!aw buckle 9 can mo.ve axially and i!la:siir-aily oofom, radially lnwi:lfd, pg, 11; intended use, thil angled upper smfacil of buckle 10 can
`e!aetlc.i!,y detorm !he buck,e 9 Inward fo;- ltJckinQ).
`~ radh]~ refS'1~vi~: :s::..H·k~~~ pt1Si~tiot)~d pr~x!r=-~~tss U:fs it~b of· thfi ~'3ck~n~ IT~~-:rnb~r in u-~s::~ kx::k:.:"'!cl pQs;ltk1n {t~ppssr zsng:::-::d ~s .. Ht~,t~~ ~f' '-'~k::.~v bt~~1~tfs
`!~. Fig .. l}} 1 ,~f1~:~1!f'i ~h~ r~ilss! r:.:1ff}~~v~i :S.tirfx~c~ !~ ssng~~d k~ ~~:t~v* tf~-3 t~h r~xi~~U>• h:-...'io•ssRi wt:ssn th& f~ns.t tss~ rno~ffSt3 fh .. 1n1 th~1 h.1i-:~ssd possW~n
`tO'.-\'~S:"{~ th~3 L:r~k)C~~uj :JO~~m~3n {flg,, 4~ C!i~¾V bt~Ckh:~ f:S C~f~ B1~V~3 ii}:.;2~tt ~r~d ~.;itUt~:h,~ d~3kWfYl i\~t3~~3i~y ~niN2ft§~ pg. 'i "): l~k~t:-..• ~:) s~ df~l~ch~~ij fn.ini
`th~ kr-JfS?t~d bu~!-:J~ 1'.0 R)r s~:-)[Sr:..~t~on~ P~l- 'i ~~; ~n~~ndtsd :..~Si&\ th* ~sng~*cl m.:rfa~::ts iJf thk~ ~k~~v ~~i~~h~r t:vi~h ttu~ bt~~~!~ '] tl ~11f3~• t~~:.ni~ ih~ ~~~\.\'
`9 t~, f'l~)V~ k\,~•";?'l.i ,"';Ur:r,:-; :..n-..:t)t'Vit•f.!}. ... :~10
`~3n ~~~a! :~~11:tsv~3~ m.:rf:sc~ pt3sak)~1ssd pni~irn~tss th& &hl~ {~x".~~~-'~t ;.~rtg~t3d :St~rff3C~ of tx.~~·J:J~ i~) p~tJ~~n1:.:::tt3 k1 th1!3 r~~:t3ss 3n ~:J1~S31h. s.e~t 5, F~g.
`4} an~ ~~:~i~~i t~ mO\if: th~ flrst tssp !tJn~ih.s~Jn~Hs• ~~.;;a:f fR;rn ~h& ~~~cx)~:d c~3p wh:s:n ~~i"~ nnst t~p ~novs::~~ fr:..1~"1~ l~S? ks~;~i~ p~~)'its~~ed t~~~~f3rd
`th~! tmi~c~ed pQsmon (F~~- 4~ di3\~? b;..~~:k!~1 9 c;s~ ~~1~',J& ;;~~fai!~y ~~rid ~~ii~$i~caHy d~1ft)~rti r~d~E3~~-· !~~~'E3tU~ tJQ,. ii: d~w ~) ~ d~~t~ch~d fi1.1~~1 H1e:
`lnv~:tt~d buckle it~ f~"}:" 5~~-..~~~t~an, pg. ·12; ifft~nd~td l~S:~~ ~ht1 t:SSlg~tXi ~t.~\:ssr ~UJ:'1~c:e tJf b.t~t~d~i '10 ~:}~~tht:H' ~¥Ith th~ ::1Nij~d ~l~tf~Ct1 t1f th~~ t":J::1\-.'\f
`can elsisiicislly deform !he tmckle 9 inws,d for unlocking).
`
`Claims i, 3-4, 6, ai.d 12 lack novelty undar PCT Article 33(2) as being m1ticlpated by US 5,31,)1, 152 A io Patterson.
`
`R~~g~~tling ~lah-rl ·1 ~ P;.~Ussri-:..1~: i~1~t~'m:S a tSS~ ;.~s;.s~n1b~·t &-:sr :.::: tf3ihetf!t {htJb:S -:..1f Cf31hQtsr ass&sn1b!·t cornpk~rrmr:t:.~~y· Eind rol~tfS~J!}:' ~~ngagi~abte,
`i\-h~tr~~ctil ~~!g~~- f'~-ll}. ~f:f3 c::1p ;~ss*rnb~y eo:"1:p~is.in9:
`
`
`
`,;~1!;!~,(~~:l (~:;~:;;;• n~~:;l~~~~~~~j~;~:~i:~;;!l~t~l;;;~~;:~ \~~,:~~~:!~,~~~l;;:r~!~~f~'.'};!;:•;)1~~~1 ~•~!~"~:i:~:~•~~l!;i~~!t~ -~il~~;-;;' ~!:~1;;;,l;/,,;;
`
`,~ .. ,~ \ \ h~ :;J}l-3'1 ); ;:en~i
`i PO ~!,p.•·i.,:.:By rlkti'n;s~ .. ~i tr1 dis:tt~~ ~,rt:! _.,~: ~:rs:t eah ?·P~ F·;fJ,. 7 1
`~ s;~e:.."-t::~id &;~p {ht.3b a5. f-=lg. 7--9, t~)!~ 51 !:1 24<29) inckKiing ;.~ k1tidr~g t~::1ttJn.~ (k:c~Sng S?~ss~nt1r~t rJf' hub 35 Bndtsdk:g t1n~t prf .. ~F3~~Son i 50 ;.~rid
`rlrt~t ~~~t ll15, ~~lg, 1-·lt co:. 51 tr.:, (~i-·3-4) ~~~1e.u~hi th¾~ k~cklng f~attifl.~ h"~ch..H:·Si~~ ~ s~ot ~X~QNdSng !:li ~~~i~~t p[HiiaU)$ t~~S"O~~g~~ ii~~ ~~i~~nd t~sp {tk)t
`1 tlt1~ Fig., 7· .. g;, ;;u1d \Vhiffe!n-----·
`tha m~~ s:;:~;,J ls c,)r:flgt::·i~d t~) be s~u;twf::~j ~c tMt~ -s~)c:and c:~3p in a ~cr;k~ffl pos;~t~cn {ht.~l~ .25 ;;~nd ht.tb ~)£.t S1":~1)-: tH~ ~-:1~£i;h~3r~~ca~~1J h'di~rk-:cked~ t~tJt
`5. ;~1 -:t5,~1i1). in th~ h."3tk~-::-d pt':::sm~)~1) ih~1 !~1-:::h:Jng ff$~tutf:S iss c.:..1f:fl@:Jred k':: ff;:lt~lvss tha kX":kh"::~) rtH:~nib$r H)?t~ilijh U~ft Ek-:i {ts"1~ch~tSSt;;aH}~
`~ni~r!rsdtssd by fr~ssssrtk:9 t:.1b :i\1 ~\4th p~n 1 DG hik1 ssn~:.1~·1~~-::d opt-::rs ffnd rii ssl~i 1 t1.:5, Ct'!!L 5~ !r: t~.5-"'4i1) sstH.-:h !h3St the:: i:.~b S?ng:.1g~~s a µr.3rfa:'!!n ti th~
`S~t'tS:"~d ~~p {:-)fOjt;.-C~k)f": ·1 tiO of h~Jb 3t~ !t Ct~P(p!i~1,~ni~IY v~dth pSn lOt)~ s-.·i.lt Jj~ ks :~(}-:~4} 3.--S i~~h~b~t ino\.~Qrn~nt oi fhQ firr~l Ci~P r~!i~Uve tt3 th*
`~~~~XW:d t.~3,p {r~n,~ t~~b ~:o ¼i:fth ph: ']{lt1 U$ ~;1gE~get"i \'\•·~U1 ~!ot it~~.1 1 ~x:·fs~ dk~i~ng~sg~r:~~ni ;s p~~~duQ~d b$' proJ*ti~~n ·1ti0~ ~ot ti~ k~ 5il:55) .. ~nd
`tr;ss fks;t c.£:Sp i~ ct1r!f~g;.::·~d at.$ rt)iat~ .r~l2:SHv~~ ft.3 lh{:1 e;i$~~nd n..:sp to ~1":n\•·tz ~1~ tab ~)t:t of' ~"!~l~f:S§~1~1'3~nt \"'~th iht1 s;fSQ-:.w:d ~i$p it) ~-r3i"...~v~~ th~ g§rst
`~~P frorn thi:B !Oc~~d f.SGB,iU~1:: ~o t:1~1 t:nk1tkf-tci p~~mrsn {ciU::sior ht?b ~~5 and Sntn.1cluc~r hub ~~5 ~r~ releass~b~$· ~nt~rk:ck.::-::d to prrJv;oe ~··f~ssfasU.3nc{:1
`lo rr~f;~tk1nt3l ·d!s~r:gi3g~rrn~~~tl ~":01, £~.i ~n 24--:~£1; ~~3ir~t:.~r~t"f~ post~d bi k~ttnfer]s-]~ Pf3itk~~1& ~;f sk)t 1 t~fj h1h~bSts~ i~ccidQn~i3~ r~1tfs1~!)na~
`tilse:1~e]ge~1;~t:t n~ the op~-so~i~!i~ c;Stt;u1~1Th1:·et:~~: dir~ctk~f?.L eat 5. ;s1 s:1,Iit~l ·t~1l, 4, h1 4I~-... 46: unk$t}ki~ pos!t.§t)~1l F~!fJ .. ~.;'•~ lir1µ!ijdUy. h1.Jbt 2s 2~1d
`35 ca:: b~ h)i&nik.·H1ti!iy n.'::tatad !n ~fH:: l1f$-postte d:'tt~~·rst~r~~NH2:S! rHn"t.ciltw~ to t~v~~r~~1n-:e th~ rt1s;~s;t;jnce ~tJs~d and lo s-~-::~~1asa U)e ir~!I$~'ks~:J~).
`
`Regarn!ng claim 3, Palteroon teaches Um cap assembly of claim 1 wherein !he tab i!:l(tends perperid!cu!miy frnm the locklng member {pin
`100 e:-o:tsnde perpandic,::ariy from distal e;id of !ab 29, Flg. 7).
`
`Hegiini!ng r~ii3$n; 4 1 F~~~tie:·i~t)n ti~i3cii*S ifle ~~3 ai~er11t1lv of (j[~in1 ·1 \.vher·~~n thi~ i~t3 Q*fo"'!e-s a rr~li~~n~ng surtac~3 (phi ·HJt) di3fines r~~c~~~
`bet\"'leen ~ln 1Ctl anil tat; 29, F!g .. 1) pt')$!tklned ft)t;ont.;~ct ~~t ~~~ast ~~ por~"'k.)n cfih~~ s~":l~Und cap \.,~tu~r: b-,t~ fa"'$t c.;~p is ~~1~;p~i~d tl1 the $~ftXlnti
`c~1~· (t{:1t:tiS,n~ ~1n-zjf$~Uon ·1 SO, F~g~ 1. Ct)i _ 5. !n 3 i .. ;.~~-).-
`
`Riigard!n~ cla!rn 8, Patt~f!£on ~ead1i~ii ~h~ tt1p ~s;~~i~n-:b!;·· t:lf ~~t3l~11 i ,~:her~1S~ !he iotJd~g Th":t3!i,~~1:z Si·n;h"~es; Ei ~ock~~1g s;un\)c~z (,prt1j~!r;t~on i 50.
`Fig. ·7, c.::.:1t. S, in ~1 i .. ~)4) po5Wont~d to ::~1 ~f$~St ~f:Stt:::1i~y cl1ntact th~ t:1b tif t:1fi !t1c};h1~1 ~1s~n1brU"· ~vh~n ihe fl~nt c:.~p I$ t":t)l~p!~cl it) the ~ect1nd c~p
`(pr~jsscl~e~n ·15t1 ~1f hub 35 is ,":.ornpHrr~-~rst~ry v1m: ~in it;O. et1L 5, ~n aO"'·~l4; tJnc~ tf.3b .~!9 \i!.,4tt~ pin 10(1 an.~ *ng~~)~fl '-!¥iU1 sk1t itJi\ as:;i~!
`a:~~:1~fSij~rnsr~t is p~·~ch.Jcl~d hy projt3cHan i~O. ::~t 5. !~1 5fl-&~}.
`
`R~~fJBn.i~t~~ t":h:dni i 2~ Fi~tr~$~:St1n h~~·::1~\~rs ~'m t"'.2~P ~$z;~rr~h~y ri c:k~:rn i vlh~"!ni!n ~h~'!- &1tidNQ n:iin1ber ~-s a flt$t k.1c}dnt) ~1'3§:n1biff {Fig. 7). \-Vh:::~~1~~n
`th:?.$ !rJ~~lng f~i:Sh.:r::~ I$ B t1~~-st kx-::king !~:.~tiff~ {.Fig, ·i\~i1), ~~h~rak! thS? n~-st t'.;:~fJ jnctt:d~~ &)~-:{:~ tsr n1~r{:~ S!:?.$~ond-h::s~kSng rn$?n1bt1rs (s~~Qnci k~b 21::l.
`FlR "'l), ~vht~ITs3n th::1 s~:.-:an~ c:aµ !n~!1Jd~S: ran~ rsr t~:or~ sss,xx~d ~ot*Sng ~~.s~s._ir~~ (E~tor~d p~13§8clk)n 150 ~rsd S.*S:t"::"nd s.k1t 1~1f5~ F]~,- f .• f§}~ and
`~v~~{:1rs!n \nd~vki~~i~l cn::1S: of ttH~ :s:~cond kxJ:JNg; n--..~1;nbt1IT~ ;.~rt.3 s;:or)~1gur*d S~3 r~c~.:S\ft3 ;.~~id msctWt3 ;:.~rrss~po:ndin~) t3nss-_:s of ~h~1 s~t-:rJnd kx~k!rii1
`m!Smber:s in th!S locked po~ltion {mechan!cally in!ef!oclmd by !n:s;sirtlng !ab :,w wi!h pin ·1 tm !11!0 enlarged open end cf slot '105, col. 5, in 45-
`• 49) such that \he tab engages a portion of !he secm;d cap {projection n.,o af hub 35 is r.omplirnen!my wi!h pin 1 OD, col. 5, In 30-34 ).
`
`-581-
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCH1NG AUTHORITY
`
`PCT/US 23f6092i'
`
`In casf tile ~p::u:s: in smy of tile pirs:s:s:ding boxs:s; is; ant ~~ffident
`Continuation of:
`-'-Supplemental Box • Box No, V,2 • Citations and explani3tions-•-
`
`Claim 13 lacks an hweritive step under PCT Article 33(3) as being abvlous aver Patterson in vlew of US 2021/0404464 A1 to S.PJ\~ Fl.-.iw
`Contml. Inc, (hereinafter 'Flow').
`
`Regarding claim 13, Patlerson teaches the cap i3ssembly of claim 1. While Patternon tei3ches di!1>tor hub 25 and lnl:mducer hub 35 are
`releasably interlocked to pmvlde reslstam:e ta mtatimml disengagement Patterson foils to teach wherein the locking feature is configured
`ta be mtatlonal!y agnastic such that rntatlor. of the first cap relative to the second cap !n a first direct!ori and a secaml dlrectian opposite
`the first direction moves !he tab cut of er;gagement wiJ:h the i;eccnd c1,p to move the flrn! cap fmm tt1e lacked pm,ltlm1 !o an wn!ocked
`poi;ltlon.
`F!o<,'ii timches el system (Abstmct) wherein a locking feature ls configured to be rotatloni3lly i3gno,itlc (moving from el 1lrnt position to a
`second posltkm in either a clockwise dlrection or a cmmierdockwise direction, pam. {0011)) mJCh that rotation of a flmt element ra!aihm to
`a second element lr. a first direction and a secand direction opposite to the !he first dlrection maves a tab owt m engagement with the
`second cap to move the flrn! cap from the locked position to an wn!ocked position {plug 196 can be rotated within pert 166 in a clockwri;e
`direction or a counterclockwise direction from the locked position to ihe wnlocked position, pam. [0074!; m,!ocked poslilon wherein the at
`least one key !s al!gned w!th the keyhole, Abstract, locked position where a sidewall ofthe keyway blocks the key from backing owl, para.
`[0008)). It would have beer. obvious to one of ordinary skm in the art that the assembly of Patterson could have been modmed 1.:11, claimed
`In view of Flow to al!aw for qwick detachment ofthe locklng elements of Patternon.
`
`Clalms 1·13 have industr:al applicability as defined by PCT Article 33(4) becawse the subject matter can be made or used by lndui,try.
`
`-582-
`
`

`

`(19)
`
`(12)
`
`Europaisches
`Patentamt
`
`European
`Patent Office
`
`Office europeen
`des brevets
`
`111111111111111111111111111111111111111111111111111111111111111111111111111
`
`(11)
`
`EP301340481
`
`EUROPEAN PATENT SPECIFICATION
`
`(45) Date of publication and mention
`of the grant of the patent:
`15.04.2020 Bulletin 2020/16
`
`(21) Application number: 14818501.0
`
`(22) Date of filing: 27.06.2014
`
`(51) Int Cl.:
`A61M 25101 (2006•01J
`A61M 39108 (2006-01)
`A61 L 29108 (20o6.o1J
`
`A61M 25106 (2006•01J
`A61L 29102 (2oo6.0tJ
`A61 M 25/00 <2006•01!
`
`(86) International application number:
`PCT/US2014/044519
`
`(87) International publication number:
`WO 2014/210427 (31.12.2014 Gazette 2014/53)
`
`(54) INTRODUCER SHEATH FOR RADIAL ARTERY ACCESS
`
`EINF0HRSCHLEUSE FOR RADIALEN ARTERIENZUGANG
`
`GAINE D'INTRODUCTEUR POUR ACCE.S ARTERIEL RADIAL
`
`(84) Designated Contracting States:
`ALATBEBGCHCYCZDEDKEEESFIFRGB
`GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO
`PL PT RO RS SE SI SK SM TR
`
`(30) Priority: 28.06.2013 US 201361840764 P
`
`(43) Date of publication of application:
`04.05.2016 Bulletin 2016/18
`
`(73) Proprietor: NorMedix, Inc.
`Plymouth, Minnesota 55447 (US)
`
`(72) Inventors:
`• WELCH, Jeffrey M.
`Maple Grove, Minnesota 55311 (US)
`
`• SUTTON, Gregg Stuart
`Plymouth, Minnesota 55447 (US)
`
`(7 4) Representative: Schwegman Lundberg Woessner
`Limited
`Hillington Park Innovation Centre
`1 Ainslie Road
`Glasgow G52 4RU (GB)
`
`(56) References cited:
`EP-A2-1 068 876
`WO-A2-2005/072806
`US-B1- 6 197 014
`
`WO-A1-2013/003835
`US-A- 5 938 587
`US-B1- 6 689 120
`
`Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent
`Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the
`Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been
`paid. (Art. 99(1) European Patent Convention).
`
`Printed by Jouve, 75001 PARIS (FR)
`
`-583-
`
`

`

`[0009] Examples of the disclosure include a radial ar(cid:173)
`tery catheter introducer sheath for introducing interven-
`tional catheters into the vasculature comprising: a main
`tubular shaft comprising a distal tip, a proximal end, an
`inner layer, a main structural layer and an outer layer;
`[0002] Currently, vascular introducer sheaths used to
`wherein the inner layer comprises one or more layers of
`polymer with a thickness of 0.0254 - 0.127 mm (0.001 -
`access radial or femoral arteries suffer from various lim(cid:173)
`itations. These include buckling or "roll-back" of the very
`0.005 inches), the main structural layer comprises one
`or more metallic helically wound multi-filar wires with a
`distal tip upon entry into the skin. This is caused by a
`wall thickness of 0.0381 mm to 0.254 mm (0.0015 inches
`poor or abrupt transition or step between the introducer
`to 0.010 inches); wherein the outer layer comprises an
`tip and the dilator that is inside the introducer to provide
`a transition from the guidewire to the sheath. Roll-back
`outer polymer jacket that at least partially covers the inner
`can also be caused by inadequate mechanical structure
`layer at the distal tip, and the outer polymer jacket is
`of the sheath tip.
`coupled to the main structural layer; wherein the outer
`[0003] Another limitation of current vascular introducer
`polymer jacket has a thickness of O. 0254 mm - 0 .254 mm
`(0.001 inches to0.010 inches); wherein the distal tip com(cid:173)
`sheaths is the overall diameter of the introducer can be
`prises 2 or more layers, these layers formed of the outer
`too large, such that excessive bleeding upon removal
`and/or arterial spasm during use can be caused. This
`polymer and inner polymer, and the distal tip has a length
`of 1.27 mm and 7.62 mm (0.05 inches and 0.30 inches).
`limitation can be due to excessive wall thickness of the
`[0010]
`In an embodiment, the main tubular shaft can
`introducer related to current introducer construction
`have an outer diameter of 1.524 mm to 4.064 mm (0.060
`methods.
`[0004] A further limitation of current introducer is kink-
`inches to 0.160 inches). The main tubular shaft can com(cid:173)
`ing or buckling during manipulation, insertion, or with-
`prise an inner polymer layer, a main structural layer com(cid:173)
`prised of multi-filar wires that have been swaged into a
`drawal of the catheter through the sheath or due to ex-
`rectangular cross-section and covered with a metallic
`cessive cutaneous tissue thickness. The kinking and
`buckling of the introducer can be inherent in the construc(cid:173)
`wire braid and an outer polymer jacket. The distal tip can
`also comprise two or more layers, such as a layer of
`tion and design of currently available introducer.
`[0005] EP 1 068 876 A2 discloses a catheter inserted
`PTFE and a layer of Pebax.
`[0011] This summary is an overview of some of the
`into, for example, a blood vessel for use and a method
`teachings of the present application and is