Edwards Lifesciences Corporation et al.
`
`Edwards Lifesciences Cororation et a1. Exhibit 1078
`
`v B
`
`oston Scientific Scimed, Inc.
`
`|PR2017-00060 (U.S. Patent No. 8,992,608)
`
`Petitioners’ Demonstrative Exhibits
`
`Oral Argument: December 19, 2017
`
`Edwards Lifesciences Corporation, et al., Exhibit 1078
`
`

`

`The '608 Patent
`
`

`

`’608 Patent: THV with ”flaps” and ”pockets”
`
`
`
`'v430
`
`5‘4
`
`i
`
`‘
`
`“diseased
`
`
`
`"interface"
`
`
`
`aortic valve”
`
`ment creates a seal around the replacement valve.
`
`“native valve
`
`leaflets”
`
`“blood"
`
`- A fabric seal 380 extends from the
`
`distal end of valve 20 and back proximally over anchor 30
`during delivery. When deployed, as shown in FIGS. 33 and
`34, fabric seal 380 bunches up to create fabric flaps and
`pockets that extend into spaces formed by the native valve
`leaflets 382, particularly when the pockets are filled with
`blood in response to backflow blood pressure. This arrange-
`
`Ex. 1001 [’608 Patent] at 14:21—29 and Figs. 13, 32—34; Petition [Paper 1] at 29—34.
`
`3
`
`

`

`The Problem of Leaks Caused by Irregular Vessels Was Known
`
`Surgical Heart Valves
`
`”The sewing ring is upholstered with a ring of compressible cushion material which will
`conform to irregularities in the bed in which the valve is placed whereby a good seal
`is established and leakage between the valve and the tissue is prevented."
`
`Ex. 1011 [Starr—Edwards Patent] at 1:42—46 (emphasis added).
`
`Stent Grafts
`
`”Type | failures relate to leaks between the vascular prosthesis and the vessel wall... Type
`| endoleaks are also caused when circular prostheses are implanted in non-circular
`aortic lumensl which may be caused by irregular vessel formation andlor calcified
`topography of the lumen of the aorta AA."
`
`THVs
`
`Ex. 1005 [Elliot] at 11 [0004] (emphasis added).
`
`
`”Most importantly, the cuff portion of the present invention is intended to reduce
`perivalvular leak around the valve. Using such a cuff to create a seal between the
`valve structure and the aorta prevents perivalvular leak .
`.
`.
`
`Ex. 1059 [Bergheim] at 12 (emphasis added).
`
`Petition [Paper 1] at 3—4, 7—24, 57-62, 66; Reply [Paper 33] at 4—17.
`
`

`

`Fabric Seals Were One of a Number of Known Solutions to
`
`Address Paravalvular Leakage (PVL)
`
`° Seals were known from surgical valves, stent grafts,
`and THVs
`
`- PVL also addressed by, e.g.:
`
`— Proper sizing and ”oversizing" of the prosthesis
`
`— Proper valve placement
`
`— Improved imaging techniques
`
`Seals: e.g., Ex. 1005 [Elliot], 1006 [Cook], 1019 [Thornton]; Ex. 1046 [Wood Dec] at ll 37; Petition [Paper 1] at 3-24; Reply [Paper 33] at 26.
`Proper sizing and oversizing: e.g., Ex. 1046 [Wood Dec.] at 1111 29, 30; Reply [Paper 33] at 26; Ex. 1049 [Patriot Design Rev.] at 39, 41;
`Ex. 1052 [Freeman] at 4, Ex. 2096 [Wood Tr.] at 17:1—10.
`Proper valve placement: 9.9., Ex. 1046 [Wood Dec.] at 1111 30, 31; Reply [Paper 33] at 26; Ex. 2003 [Thourani] at 7.
`Wages: e..,g Ex.1046 [Wood Dec.] at 11 30; Reply [Paper 33] at 26, Ex. 2096 [Wood Tr] at 26:17—27:22, 30:13—31:10.
`
`

`

`The ’608 Patent: Claim 1
`
`Claim Element
`
`Claim No. /
`
`Subpart
`
`1 (preamble)
`
`A system for replacing a heart valve, comprising:
`
`1.1
`
`1.2
`
`1.3
`
`1.4
`
`1.5
`
`1.6
`
`1.7
`
`1.8
`
`1.9
`
`
`
`an expandable anchor having a collapsed delivery configuration and an expanded configuration, the
`expandable anchor comprising a distal end;
`
`a replacement valve commissure support element attached to the expandable anchor;
`
`a commissure portion of a replacement valve leaflet attached to the commissure support element; and
`
`a fabric seal at least partially disposed around an exterior portion of the expandable anchor when the
`anchor is in the expanded configuration,
`
`the fabric seal having an undeployed state and a deployed state,
`
`wherein in the deployed state the fabric seal comprises flaps that extend into spaces formed by
`native valve leaflets;
`
`wherein a distal end of the replacement valve leaflet is attached to the fabric seal
`
`and when the expandable anchor is in the collapsed delivery configuration, the fabric seal extends from
`the distal end of the replacement valve and back proximally over the expandable anchor,
`
`the fabric seal being adapted to prevent blood from flowing between the fabric seal and the heart tissue.
`
`EX. 1001 ['608 Patent] at 22:22-42.
`
`

`

`The ’608 Patent: Claims 2-4
`
`
`
`Clalm NO- /
`Subpart
`
`Claim Element
`
`The system of claim 1, wherein, in the deployed state, the fabric seal defines a
`plurality of pockets
`
`The system of claim 2, wherein the pockets are adapted to fill with blood in
`response to backflow blood pressure.
`
`The system of claim 1, wherein the expandable anchor is formed from stainless
`steal or nickel—titanium alloy.
`
`Ex. 1001 ['608 Patent] at 22:43-48.
`
`

`

`What Is
`
`Required by Claims 1—4?
`
`- Claims do not require use with calcified native leaflets
`
`
`
`— Ex. 1001 ['608 Patent] at 22:22—48; Ex. 1045 [Buller Reply Dec.] at 11 40 (claims require no
`degree of calcification); Reply [Paper 33] at 1, 6-7, 9.
`
`- Claims n_ot limited to a particular type of heart disease
`
`— Ex. 1001 [’608 Patent] at 22:22—48; Ex. 1043 [Brecker Tr.] at 90:24—91:13 (claims cover pure
`aortic regurgitation); Reply [Paper 33] at 7.
`
`- Claims do not require "bunching up" of fabric seal
`
`
`
`— Ex. 1001 ['608 Patent] at 22:22—48; Ex. 1043 [Brecker Tr.] 83:12-84:5 (no requirement that
`flaps and pockets are formed by bunching up); Reply [Paper 33] at 8-11.
`
`

`

`What Is
`
`Required by Claims 1—4?
`
`- Claims n_ot limited to use in the aortic valve
`
`— Ex. 1001 ['608 Patent] at 22:22—48; Ex. 1043 [Brecker Tr.] at 895-909 (not limited to aortic
`valve); Ex. 1045 [Buller Reply Dec.] at 11 40 (same); Reply [Paper 33] at 1, 7, 14.
`
`- Claims do not require foreshortening of anchor
`
`
`
`— Ex. 1001 ['608 Patent] at 22:22-48; Ex. 1043 [Brecker Tr.] at 84:14-85:9 (no foreshortening
`required); Ex. 1045 [Buller Reply Dec.] at ii 32 (same); Reply [Paper 33] at 8.
`
`

`

`Prosecution History of ’608 Patent
`
`"An implantable fabric having pleats and pockets is well known in the art, as taught
`by De Paulis in Figure 2, and it would have been obvious to one of ordinary skill
`in the art to modify seal of Leonhardt et al. to include pleats as an obvious
`alternate design choice."
`
`Ex. 1002 [’608 File History] at 353 (emphasis added); Petition [Paper 1] at 37—38.
`
`Leonhardt THV
`
`De Paulis Graft
`
`circumferential
`
`corrugations 13
`
`or corrugations 16
`
`valve stent 20
`
`longitudinally
`extending pleats
`
`Ex. 1027 [Leonhardt], Fig.2
`
`Ex. 1021 [De Paulis], Fig. 2
`
`10
`
`

`

`PO Further Limited the Fabric Seal to
`
`Claim 9 (Currently Amended):
`
`A system for replacing a heart valve, comprising:
`
`an expandable anchor having a collapsed delivery configuration and an expanded
`
`configuration, the expandable anchor comprising a distal end:
`
`a replacement valve commissure support element attached to the expandable anchor;
`
`a commissure portion of a replacement valve leaflet attached to the commissure support
`
`element; and
`
`a fabric sea] at least partially disposed around an exterior portion ofthe expandable
`
`anchor when the anchor is in the expanded configuration, the fabric seal having an undeploy'ed
`
`state and. a de 10 ed state
`
`-
`'
`'
`
`
`
`wherein in the deployed. state the fabric seal comprises flaps that extend into spaces formed by
`
`native valve leaflets;.—aad
`
`
`wherein a distal end of the replacement valve leaflet is attached to the fabric seal and
`
`the fabric seal being adapted to prevent blood from flowing between the fabric seal and heart
`
`
`tissue.
`
`Ex. 1002 ['608 File History] at 358 (July 9, 2014 Amendment at 2); Petition [Paper 1] at 37-39;
`Ex. 1007 [Buller Dec] at 1l1l 114—17; Ex. 2094 [Buller Reply Tr.] at 55:23—56:18.
`
`11
`
`

`

`PO Argued that a Fabric Seal that “doubles over”
`
`the Anchor Is a Novel Feature
`
`— reproduced
`
`below— Further. paragraph
`
`[00l 12] states, in-part. “a fabric seal 380 extends from the distal end ol‘valve 20 and back
`
`proximally over anchor 30 during delivery."
`
`to prevent blood from flowing between the fabric seal and heart tissue,“ as is claimed.
`
`In contrast.— whether considered independently or
`
`in combination, teaches, suggests, or otherwise—a “when the expandable anchor
`
`is m the collapsed delivery configuration,—
`
`_ the fabric seal being adapted
`
`Ex. 1002 [’608 File History] at 360—61 (July 9, 2014 Response to Office Action at 4—5); Petition at 38—39;
`Ex. 1007 [Buller Dec.] at in 114-17,- Ex. 2094 [Buller Reply Tr.] at 55:23—56:18.
`
`FIG. 32
`
`fabric seal doubles
`over the anchor
`
`12
`
`

`

`— A Fabric Seal that ”doubles over” Anchor Was to a POSITA
`
`Cribier (1996) [Ex. 1003], Fig. 6d
`
`'608 Patent, Fig. 32
`
`1!.
`
`a
`
`19
`
`19
`
`‘
`
`_
`
`-
`
`.
`
`distal end of
`
`replacement
`vaNe
`
`
`
`19'
`I
`fabric seal doubles F___'G_6-d“
`overtheanchor
`
`Petition [Paper 1] at 1-3, 19—22; see also, e.g., Ex. 1033 [Bessler]; Ex. 1009 [Pavcnik]; Ex. 1004 [Spenser].
`
`I FIG 32
`
`fabric seal doubles
`
`over the anchor
`
`13
`
`

`

`’608 Patent’s Alleged Invention
`
`FIGS. 32-34 show another way to seal the replacement
`valve 21 ainst leaka e.
`
`34, fabric seal 380 bunches up to create particularly thn thc pockcts arc fillcd with
`
`When deployed, as shown in FIGS. 33 and
`
`Ex. 1001 ['608 Patent] at 14:21-29; Petition [Paper 1] at 2-3, 37-39.
`
`blood in response to backflow blood pressure. This arrange-
`ment creates a seal around the replacement valve.
`
`Ex. 1001 ['608 Patent] at Figs. 32-34.
`
`14
`
`

`

`Petitioners’ Claim Construction: ”Flaps”
`
`Petitioners’ Claim
`.
`Constructlon
`
`District Court Construction
`
`Reply [Paper 33] at 3 n.4.
`
`"circu mferentially oriented
`folds or unattached ends"
`
`"[f]abric projecting
`from the anchor"
`
`Petition [Paper 1] at 43;
`Ex 1007 [Buller Dec] at 1111 118-27.
`
`Ex. 2032 [D. Del. Claim
`Construction Order] at 3;
`
`- PO did not offer a construction in the IPR
`
`15
`
`

`

`Petitioners’ Claim Construction: ”Pockets”
`
`Petitioners’ Claim
`.
`Constructlon
`
`District Court Construction
`
`"open spaces or cavities
`formed by flaps of the
`fabric seal"
`
`"[c]avities formed by
`the fabric seal"
`
`Reply [Paper 33] at 3 “~4-
`
`Petition [Paper 1] at 45,- Ex. 1007
`[Buller Dec.] at 1111119—24, 128.
`
`Ex. 2032 [D. Del. Claim
`Construction Order] at 3;
`
`- PO did not offer a construction in the IPR
`
`16
`
`

`

`Institution Decision and Trial
`
`

`

`Institution Decision (Obviousness Grounds 7—9)
`
`Reference(s)
`
`Spenser and Elliot
`
`BaSIS
`
`§ 103
`
`Spenser and Thornton
`
`§ 103
`
`Spenser and Cook
`
`Claims
`
`Challenged
`
`§ 103
`
`
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that inter partes review is instituted in IPR2017-00060
`
`with respect to the following grounds of unpatentability:
`
`claims 1—4 as obvious over Spenser and Elliot under 35 U.S.C.
`
`§ 103(a).
`
`claims 1—4 as obvious over Spenser and Thornton under 35 U .S.C .
`
`§ 103(a),
`
`claims l—4 as obvious over Spenser and Cook, under 35 U.S.C.
`
`§ 103(21):
`
`Institution Decision [Paper 7] at 24.
`
`18
`
`

`

`There Is No Dispute that Spenser (2001) Discloses Nearly All Features of Claims 1—4
`
`Support Beam
`
`Annular Support
`Stent
`
`
`
`I?
`
`Cuff Portion
`
`2. J”
`
`4— Tricuspid Valve
`Assem bly
`
`Ex. 1004 [Spenser], Fig. 1; Petition [Paper 1] at 2—3, 21—22, 66-75; Ex. 1007 [Buller Dec] at 1111 83, 175-91; Reply [Paper 33] at 1, 3-5.
`
`19
`
`

`

`Spenser Recognized the Problem of Leakage
`
`
`
`(12)mamumnmmmmmmn
`
`
`
`(l9) Mlnldbunllmrmwm
`Maui—Ll Elle“
`
`
`
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`7
`“I. lwhml r-uml— M
`
`lib-“m (W)
`PCI‘
`W0 ”SKIING! Al
`flthIIflIflMIWW Mllm‘ mwmwnln.mmmuzm
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`a!) mutual my. Nun-am mamas:
`(m wmmmymumu. mum.
`MMD.FQBI~IY.BZCA.GLDL®.CLCIL
`on human-Imam 11 munmaxm)
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`'
`WHILEIMDJLDQBJH mmumuu;
`an "um"
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`on mum-m
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`mmmummnmulmmmm
`nmmmunmmn us
`mm,z,\_m.m
`awe-15.19
`(n) ‘WwflMfl-fi-u—I‘Lfimh
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`can-rm.“
`
`re 61!
`To p v t bakage
`
`flamflleinlet° 13°
`It
`
`“mm“
`m,
`.
`[mum/11mm
`1mm mu; 1
`In All.“
`mgr- wall afthe inlet maths edge. ofthe flame so as topresentmlled-up sleeve-like portion at
`mm: mm
`
`9mg
`11
`‘
`’
`optimally possible to to up 3
`
`‘
`slack
`
` 8A1
`
`3 MAM-me Ammwwcmmmnwhwmhwm. use-win. wage—um
`l‘ mmxmwuuwm-mumuuwuyaimhawmswmma-wmi
`flaw mummwnmnmm II Emmi mhfiflundl’yminnwm hi—flwvdmhby
`\ mat-Winn!“(film-hmmhmwhnmw-mmimWiu-Mm
`“Mldhmfiunkauh‘IhmmullpWWAflu-fltynlhwuuynfldwhuflflnl
`g lawn Ankh w! mama-mum),mnaargummu (syn-ah! In Ibo-Imam (1!)mm
`O swim-amwammnmwunmmmwmmmnmumudccwmm
`-bmupuupln'£uu. uhmawflmizpmd-lxlhalll‘plbh “mdhmwmwmup—mwy
`punt-u Illa-1w” flu mm [In
`
`W ”hm:CW std Exhibit I'M pl “115
`
`
`
`Ex. 1004 [Spenser] at 21, Fig. 1; Petition [Paper 1] at 22;
`Ex. 1007 [Buller Dec.] at 11 83; Reply [Paper 33] at 1-2, 4.
`
`20
`
`

`

`Elliot, Thornton, and Cook All Disclose Flaps/Pockets for Preventing Leakage
`
`Elliot
`
`
`
`1314. be
`
`Ex. 1005 [Elliot].
`
`Flén 50
`
`Thornton
`
`45
`
`’5 /3
`
`22\
`,7//
`2/
`/5 44/
`
`/”
`
`/2
`
`1‘76 6
` Ex. 1019 [Thornton].
`
`Petition [Paper 1] at 11-15, 57-63, 71-73; Ex. 1007 [Buller Dec] at 1111 63-66, 153-63, 165-69, 182-83, 185-87; Reply [Paper 33] at 6-11.
`
`21
`
`

`

`PO’s Flawed Arguments
`
`1. Elliot, Thornton, and Cook are intended for use only in
`"healthy" tissue, rather than calcified tissue
`
`2. Spenser's "tight" seal is inconsistent with the flaps
`disclosed in Elliot, Thornton, and Cook
`
`3. Skirts of Elliot, Thornton, and Cook would not result
`in flaps that extend into spaces formed by native leaflets
`
`4. Objective indicia of non-obviousness
`
`Response [Paper 21] at 21—47.
`
`22
`
`

`

`PO’S Flawed Argu ments
`
`1. Elliot, Thornton, and Cook are intended for use only in
`"healthy" tissue, rather than calcified tissue
`
`2. Spenser’s "tight” seal is inconsistent with the flaps
`disclosed in Elliot, Thornton, and Cook
`
`3. Skirts of Elliot, Thornton, and Cook would not result
`
`in flaps that extend into spaces formed by native leaflets
`
`4. Objective indicia of non-obviousness
`
`Response [Paper 21] at 21—44.
`
`23
`
`

`

`Limited to Calcified Tissue
`
`The Claims Are
`
`a fabric sea] at least partially disposed around an exterior
`portion of the expandable anchor when the anchor is in
`the expanded configuration, the fabric sea] having an
`undeployed state andadeglo ed state whereinin the
`
`
`Ex. 1001 ['608 Patent] at 22:33—35 (claim 1); Reply [Paper 33] at 1, 6—7, 9; Ex. 1045 [Buller Reply Dec.] at 11 40;
`Ex. 1044 [Manganaro Tr.] at 6025-13; Ex. 1043 [Brecker Tr.] at 82223-8323.
`
`24
`
`

`

`The Claims Do
`
`Require Calcified Tissue
`
`PO's Dr. Manganaro’s opinions rest on the erroneous assumption
`that the claims require calcification:
`
`Q
`
`My question here is, when you read the
`
`claima and you determined what the scope of the
`
`claims is,
`
`that is what they cover ——
`
`A
`
`Q
`
`Uh-lhuh.
`
`—- did.you read that the claims require
`
`
`
`Ex. 1044 [Manganaro Tr.] at 6025—13; Reply [Paper 33] at 1, 6-7, 9.
`
`25
`
`

`

`The Claims Do
`
`Require Calcified Tissue
`
`PO's Dr. Brecker's opinions rest on the erroneous assumption that
`the claims require calcification:
`
`9-— then in this matter,
`
`you understood that a person of ordinary skill in the
`
`art reading the claims here would understand that the
`
`
`
`
`
`Ex. 1043 [Brecker Tr.] at 8223—833; Reply [Paper 33] at 1, 6—7, 9.
`
`26
`
`

`

`Require Calcified Tissue
`
`Dr. Brecker Now Admits Claims Do
`
`- But PO’s expert, Dr. Brecker, conceded that the claims include treatment of pure
`aortic regurgitation:
`
`Q.
`
`
`So it's your opinion that viiinii
`
` ilnmird,hm the treatment of
`
`
`
`Ex. 1043 [Brecker Tr.] at 90:24—9iz4; Reply [Paper 33] at 6—7, 9.
`
`- And Dr. Brecker conceded that this does not involve calcified tissue:
`
`It was WNW? native walwo weflwwqitwtimm
` where there would be he malaiumd
`
`EX. 1043 [Brecker Tr.] at 4S:4-46:1; Reply at 6-7.
`
`27
`
`

`

`Fabric Seals Taught by Elliot, Thornton, and Cook Are
`
`to Stent Grafts
`
`- Elliot's tubular prosthesis "[is] not limited to, endovascular grafts
`and stent—grafts," and also includes ”tubular conduits for
`maintaining patency in other bodily passageways."
`
`Ex. 1005 [Elliot] at ll [0001] (emphasis added).
`
`- Thornton’s prosthesis includes a "tubular member—seal member
`combination" for "the outer surfaces of implantable endolumenal
`medical devices."
`
`Ex. 1019 [Thornton] at 7:6—9 (emphasis added).
`
`° Cook's tubular prosthesis includes "an illustrative intraluminal
`prosthesisl such as a stent graft."
`
`Ex. 1006 [Cook] at ll [0006] (emphasis added).
`
`Petition [Paper 1] at 17 no 7; Reply [Paper 33] at 9 n.7, Ex. 1007 [Buller Dec] at llll 63 n.1, 65 n.2, 66 n‘1—3‘
`
`28
`
`

`

`A POSITA Knew that the Same Fabric Sealing Technology Applies to Both THVs
`
`Stent Grafts
`
`[0067] FIGS. 20-27 and 35-41 depict embodiments of
`
`resent inventions in which the device 10 comprises an— 25 that act
`
`together to regulate and au
`duct or vessel 33, or
`
`cut the flow of fluid throu h a
`
`. The coverng 45 of each
`
`
`
`Reply [Paper 33] at 9 n.7.
`
`material. The artificial valve traps retrograde blood flow and
`seals the lumen, while normal blood flow is permitted to
`travel
`throu h the device.
`
`
` . In a first stent graft embodi-
`
`EX. 1009 [Pavcnik] at W [0012], [0067], Fig. 27; Petition [Paper 1] at 24 (Citing
`Pavcnik); see also id. at 9 n.2 (De Paulis) ,17 n.7 (Thornton, Elliot, Cook,
`Spiridigliozzi), 18—19 (Andersen and Leonhardt), 25 n9 (Lunn), 61—62;
`Ex.1007[Bu|ler Decl] at 1m 63 n.1, 6S n.2, 66 n.3, 67 n.5, 87, 87 n.6,163;
`
`29
`
`

`

`PO’S Expert Admitted Stent Grafts Are Relevant to the
`
`’608 Patent
`
`- As PO's expert, Dr. Manganaro, admitted:
`
`Q
`
`And a person of ordinary skill in the art
`
`of the '608 patent would have found their experience
`
`1 to the subject matter of
`
`Ex. 1044 [Manganaro Tr.] at 42:17—21; Reply [Paper 33] at 15.
`
`30
`
`

`

`POSITA Understood that Stent Grafts Were
`
`Used in Calcified Tissue
`
`Thornton expressly discussed use in calcified tissue:
`
`"[A]s shown in FIG. ZOB, it has been observed that the portion of main
`body (700) at and adjacent to the apex strut (716) can be forced away
`from the artery wall particularly in case of calcified tissue. This action
`causes a separation (956) between the outer surface of main body (700)
`and the artery wall..."
`
`Ex. 1019 [Thornton] at 30:27—36 (emphasis added).
`Reply [Paper 33] at 6—7, 16—17; Ex. 1045 [Buller Reply Dec] at 111i 42—43, 45.
`
`Elliot expressly discussed use in calcified tissue:
`
`"Type | failures relate to leaks between the vascular prosthesis and the
`vessel wall...Type | endoleaks are also caused when circular prostheses are
`implanted in non-circular aortic lumens, which may be caused by
`irregular vessel formation and/or calcified topography of the lumen of
`the aorta AA."
`
`Reply [Paper 33] at 6-7; Ex. 1045 [Buller Reply Dec] at fill 42, 44-45.
`
`EX. 1005 [Elliot], ‘ll [0004] (emphasis added).
`
`31
`
`

`

`POSITA Knew that Aortic Calcification Was Common
`
`
`mm! Yawn-lunacy“ 0! W M)
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`
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`
`
`
`
`
`
` 0W mkmwwm (WMMMMREQI
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`mm
`
`
`
`Reply [Paper 33] at 7; Ex. 1045 [Buller Reply Dec.] at 1111 46-47.
`
`Ex. 1060 [Jayalath] at 483.
`
`32
`
`
`
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`POSITA Knew that Aortic Calcification Was Common
`
`
`
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`
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`
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`
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`
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`
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`
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`
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`
`Ex. 1060 [Jayalath] at 480, Fig.1; Reply [Paper 33] at 7;
`Ex. 1045 [Buller Reply Dec.] at 1111 46-47;
`Ex. 2094 [Buller Tr.] at 39:12—40:5, 499—22.
`
`33
`
`

`

`PO’s Flawed Argu ments
`
`1. Elliot, Thornton, and Cook are intended for use only in
`"healthy” tissue, rather than calcified tissue
`
`2. Spenser’s "tight" seal is inconsistent with the flaps
`disclosed in Elliot, Thornton, and Cook
`
`3. Skirts of Elliot, Thornton, and Cook would not result
`
`in flaps that extend into spaces formed by native leaflets
`
`4. Objective indicia of non-obviousness
`
`Response [Paper 21] at 21—47.
`
`34
`
`

`

`Spenser’s Fixed Length Support Beams Provide Anchorage for
`
`the Valve Commissures
`
`”However, the support beams remain at all times constant at their length and
`thus are suitable for serving as the pliable valve assembly's anchorage.
`The valve assembl
`is attached to the su
`ort stent at the su
`ort beams
`
`and due to their constant len th there is no need for slack material as the
`
`attachment points (25) remain at constant distances regardless of the
`position of the valve device (crimped or deployed)."
`
`Ex. 1004 [Spenser] at 22-23 (emphasis added).
`
`Valve assembly 28
`
`
`
`Petition [Paper 1] at 22; Ex. 1007 [Buller Dec] at 11 83; Ex. 1045 [Buller Reply Dec] at 1111 31, 34-39;
`Reply [Paper 33] at 5—6; Ex. 1004 [Spenser] at 22—23, 34—35; Ex. 2080 [Brecker Dec] at 11 49.
`
`35
`
`

`

`Spenser Describes that the Cuff Is Made from ”Slack” Material
`
`"To prevent leakage from the inlet it is optionally possible to roll up some
`slack wall of the inlet over the ed e of the frame so as to present
`
`rolled-up sleeve-like portion at the inlet."
`
`Ex. 1004 [Spenser] at 21 (emphasis added).
`
`Annular
`
` Support Beam
`
`Support Stent
`
`2.1”
`
`4— Tricuspid Valve
`Assembly
`
`Cuff Portion
`
`Petition [Paper 1] at 22; Reply [Paper 33] at 3—4, 5—6; Ex. 1007 [Buller Dec] at ll 83.
`
`36
`
`

`

`PO and Its Expert Offered No Evidence to Support Conclusory Assertion
`
`about the Effect of an Outer Seal on the Potential for Migration
`
`UNITED. STATES; PATENT AND TRADEMARK OFFICE
`
`l
`
`BEFORE: THE; PATENT: TRIAL AND APPEAL, BOARD.
`
`EDWARDS. LIFE aC'IENCES CORPORATION. EDWARDEa
`LIFESflfIENC‘ES LLC.‘ AND. EDW-ARDDI LIFE-SCIENCES AG.
`
`Pcfin'wzws.
`
`"In addition, a person of ordinary skill in the art in 2004 would have
`known that the addition of a loose—fitting fabric seal on the outside of
`the device could compromise stability of the device within the aortic
`annulus. With only a handful of TAVR procedures having been
`done by 2004I a person of ordinary skill in the art would have
`had little real world data on which to base a prediction of the
`effect of such an outer seal on the potential for migration."
`
`Emit-‘23:???
`1
`
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`
`Ex. 2080 [Brecker Dec] at if 30 (emphasis added);
`id. at 1i‘li 24—33 (no citations to any support for opinion on migration).
`Reply [Paper 33] at 4—5, 17 n.11, 28—29;
`Ex. 1045 [Buller Reply Dec] at 1111 28—30.
`
`supra. l “can“! v_ Rmmfipunhfic Spin-0d
`Imnllw us Panoramas!”
`Exhibit 20w
`
`37
`
`

`

`The ’608 Patent Itself Further Confirms that a Fabric Seal Was
`
`Reduce Migration
`
`pec ed
`
`US 8,992,608 82
`14
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`
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`
`Edwards Llfesdumes (hrparaflnu, at a]. Exhibit 10“], p. 79 or83
`
`
`
`38
`
`in
`
`u
`
`A:
`
`EX. 1001 ['608 Patent] at 13:47-49 (emphasis added).
`Reply [Paper 33] at 4; Ex. 1045 [Buller Reply Dec.] at ll 29.
`
`

`

`Spenser Does Not Tie the Cuff to Preventing Migration: Other Features Prevent Migration
`
`
`
`”Figure 17 describes a positioning of a valve device
`310 using an additional deployable stent 320.... and
`
`the additional stent decreases the risk of device
`
`migration."
`
`Ex. 1004 [Spenser] at 30-31 (emphasis added) & Fig. 17.
`
`"Figure 27 illustrates an isometric view of an
`implantable prosthetic valve in accordance with
`another preferred embodiment of the present
`invention having hooks designated to anchor the valve
`assembly to body ducts.... Hooks 453 assures that
`the valve assembly stays in place after deployment,
`and cannot migrate to another position."
`
`Ex. 1004 [Spenser] at 36—37 (emphasis added) & Fig. 27.
`
`Reply [Paper 33] at 4—5, 17 n.11; Ex. 1045 [Buller Reply Dec] at ‘ll 28.
`
`39
`
`

`

`PO’s Flawed Argu ments
`
`1. Elliot, Thornton, and Cook are intended for use only in
`"healthy” tissue, rather than calcified tissue
`
`2. Spenser’s "tight" seal is inconsistent with the flaps disclosed
`in Elliot, Thornton, and Cook
`
`3. Skirts of Elliot, Thornton, and Cook would not result
`in flaps that extend into spaces formed by native leaflets
`
`4. Objective indicia of non-obviousness
`
`Response [Paper 21] at 21—47.
`
`40
`
`

`

`Elliot Discloses Nearly Identical Sealing Structure to ’608 Patent
`
`
`
`’608 Patent
`
`
`
`Ex. 1001 [’608 Patent], Fig. 34.
`
`Petition [Paper 1] at 57-59, 71—72; Ex. 1007 [Buller Dec] at 1111 156, 182—83; Reply [Paper 33] at 9-10.
`
`41
`
`

`

`Elliot Discloses Flaps/Pockets to Prevent Leaks Caused by Surrounding lrregularities
`
`
`
`"[A]s shown in FIG. 3c, at least a portion of the peripheral
`edge 18 may be displaced in response to an irregularity
`in the aorta AA lumen
`
`Ex. 1005 [Elliot] at ll [0029]
`(emphasis added).
`
`"[P]ortion(s) of the peripheral edge 18 can be displaced
`to contact, and form a seal with a surrounding wall.
`Irregularities andlor wall displacement
`can be
`responded to by the skirt 16 in minimizing endoleaks
`about the prosthesis 10."
`
`Ex. 1005 [Elliot] ll [0024]
`(emphasis added).
`
`Petition [Paper 1] at 13, 57—60, 71—72; Ex. 1007 [Buller Dec] at ill] 65, 154—58, 183; Ex. 1005 [Elliot], Figs. 3c, Sc, and 5d.
`
`42
`
`

`

`Elliot Discloses Using More Than One Fabric Skirt
`
`"In addition, as will be understood by those skilled in the art, more than one
`of the skirts 16 ma be rovided on the tubular bod 12 to rovide
`
`redundant seals.
`For example, with respect to FIG. 8, a plurality of the
`skirts 16A, 16B, 16C
`formed in accordance with the second embodiment
`
`herein, may be serially arranged.”
`
`Ex. 1005 [Elliot] at 11 [0040] (emphasis added).
`
`
`
`Ex. 1005 [Elliot] at Figs. 7 and 8; Petition [Paper 1] at 13; Ex. 1007 [Buller Dec.] at 11 156.
`
`43
`
`

`

`Thornton Discloses Nearly Identical Sealing
`
`Structure to ’608 Patent
`
`Thornton
`
`'608 Patent
`
`
`
`_
`
`12
`
`M
`
`\10
`
`FIG.1
`
`,
`
`i
`
`15
`
`-
`
`30
`
`4-»
`
`380
`
`_‘
`
`’
`
`
`
`\
`
`382
`
`—80
`
`“‘21
`‘
`
`§ we???“ '
`
`
`Fla :4
`
` 1
`
`Ex. 1001 [’608 Patent], Fig. 34.
`
`Ex. 1019 [Thornton], Figs. 1 & 3.
`
`Petition [Paper 1] at 58—61;
`Reply [Paper 33] at 9-10.
`44
`
`

`

`Thornton Discloses Flaps/Pockets for Preventing Leakage
`
`Around the Prosthesis
`
`"In one variation of the invention, the implantable medical device has a tubular
`member and a sealing member.... The seal member is secured to the outer
`surface and is ada ted to occlude Ieaka e flow externall around the tubular
`
`wall between the outer surface and the endolumenal wall when the tubular
`
`member is deployed within the endolumenal body space."
`
`"In the case where the flared shape of flange
`(26) is its relaxed geometry, flange (26) may
`include an outward bias to that shape,
`such that when tubular member (10) is
`deployed into an endolumenal space (not
`shown in FIG. 1), flange (26) may engage a
`radially confining endolumenal wall
`defining that space (not shown) and thereby
`enhance the reduction of flow around
`
`tubular member (10) between outer surface
`(18) and the endolumenal wall.”
`
`Ex. 1019 [Thornton] at 7:30—42 (emphasis added).
`
`Ex. 1019 [Thornton] at 3:63—4:10 (emphasis added).
`
`
`
`Petition [Paper 1] at 11—12. 60-62, 71—