o
`
`0
`
`’ Blrd & Blrd (
`
`Bird & Bird LLP
`
`Maximiliansplatz 22
`
`80333 Miinchen
`Germany
`
`Tel +49 (0) 89 3581 6000
`Fax +49 (0) 89 3581 6011
`twobirds.com
`
`BIRD& BIRD LLP - Maximiliansplatz 22 - D<80333 Miinchen
`
`Via facsimile in advance: +49 89 2399 4465 (without exhibits)
`European Patent Office
`Bob—van-Benthem-Platz 1
`80469 Miinchen
`
`Dr. Daniela Kinkeldey
`Ext: +49 (0) 89 3581 6229
`daniela.kinkeldey@twobirds.com
`
`Munich, 17 March 2016
`
`Our ref. (please always state): EDWLI.0054
`
`The facts and arguments (point VII) for the
`
`MOE
`
`filed in the name and on behalf of Edwards Lifesciences Corporation, 1 Edwards Way
`
`Irvine, CA 92614, USA,
`against
`the European
`“Repositionable heart
`valve”
`(European
`patent
`
`patent EP 2 749 254 Bl
`entitled
`application No. 14 161 991.6)
`of
`
`Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN 55311-1566, USA are
`
`presented in the following:
`
`The opposition fee is to be debited from our account 28002046.
`
`A.
`
`Requests
`
`1.
`
`It is requested to revoke the patent in its entirety, based on the grounds that:
`
`1.
`
`2.
`
`3.
`
`its subject matter is not patentable within the terms of Articles 52 to 57 EPC
`(Art. 100(a) EPC), since it is neither novel'nor based on an inventive step;
`
`the opposed patent does not disclose the invention in a manner sufficiently clear
`and complete for
`it
`to be carried out by a person skilled in the art
`(Art. 100(b) EPC, Art. 83 EPC); and
`
`the subject matter of the opposed patent extends beyond the content of the
`application as filed (Art. 100(c) EPC, Art. 76, 123(2) EPC).
`
`Abu Dhabi & Beijing & Bratislava & Brussels & Budapest& Copenhagen & Dubai & Diisseldorf& Frankfurt & The Hague & Hamburg & Helsinki & Hong Kong
`& London & Luxembourg & Lyon 8: Madrid & Milan & Munich & Paris & Prague & Rome & Shanghai & Singapore & Skanderborg & Stockholm & Sydney & Warsaw
`Bird 8: Bird LLP is! einc Parrnerschaft mit beschrfinkrer Haftung nach englischem Recht, eingetragen im Companies House of England and Wales unter der Nummer 0C340318. Der Name Bird &
`Bird bezeichnet eine internationale Anwaltssozietat, bestehend aus Bird & Bird LLP und ihren verbundenen Sozietaten. Bird & Bird praktiziert in den oben angegebenen Standorten. Weitere
`Informationen finden Sie auf unserer Homepage.
`
`Bankverbindung: Deutsche Bank Privat- und Geschaftskunden AG, Kto. Nr. 1066 398, BLZ 300 700 24, SWIFT/BIC Code DEUTDEDBDUE, [BAN Code DE 71 3007 0024 0106 6398 00
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 1 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 1 of 56
`
`

`

`Bird & Bird
`
`17 March 2016
`page 2
`
`II.
`
`In accordance with the Guidelines for Examination, Part E, Section VII, P0int#4
`accelerated processing is requested since an infringement action in respect of the
`European patent is pending before the regional court of Dusseldorf, Germany (case
`number 4aO 137/15).
`'
`
`III. Oral proceedings pursuant to Art. 116 EPC are requested.
`
`B.
`
`Relevant References
`
`1.
`
`The opposition is based on the following prior art:
`
`1331
`
`BB2
`
`BB3
`
`BB4
`
`BB5
`
`BB6
`
`BB7
`
`BB8
`BBQ
`
`Feature analysis of claim 1 of opposed patent
`
`WC 2005/062980 A2 (PCT application of opposed patent)
`
`WO 98/29057 A1
`
`US 4,084,268 A
`
`US 5,855,601 A
`
`W0 03/047468 A1
`
`EP 1 702 247 A0 (parent application of opposed patent)
`
`US 10/971,535 (priority application of opposed patent)
`Assignments filed with the US Patent Office for priority document of
`
`opposed patent
`
`BB10
`
`WO 2005/102015 A2
`
`BBloA
`
`US 60/565,118 (priority application of BB10)
`
`BB11
`
`BB12
`
`BB13
`
`BB14
`
`BB15
`
`BB16
`
`BB17
`
`BB18
`
`WO 98/55047 A1
`
`US 6,015,431 A
`
`W0 03/037222 A2
`
`US 6,729,356 B1
`
`US 2001/0027338 A1
`
`US 2004/0082989 A1
`
`US 2003/0236567 A1
`
`US 5,411,552 A
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 2 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 2 of 56
`
`

`

`Bird 8: Bird
`
`17 March 2016
`page 3
`
`Feature analysis of claim 1 and the alleged invention
`
`C.
`
`2.
`
`The opposed patent comprises 13 claims including independent claim 1. All claims of
`
`the opposed patent relate to an apparatus for endovascularly replacing a patient’s
`
`heart valve.
`
`1.
`
`3.
`
`Below is a feature analysis of independent claim 1 which provides the following
`
`features:
`
`Apparatus for endovascularly replacing a patient’s heart valve,
`comprising:
`
`the apparatus
`
`1.
`
`an expandable anchor (30)
`
`La) supporting a replacement valve (20),
`1b) the anchor having a delivery configuration and a deployed configuration,
`characterized by
`
`2.
`
`a fabric seal (38o)
`
`2.a) extending from the distal end of the valve (20) proximally over the anchor in
`the delivery configuration,
`
`2.b) wherein the seal is bunched up in the deployed configuration.
`
`4.
`
`The above feature analysis is enclosed as a separate document (Exhibit BB1).
`
`II.
`
`5.
`
`In general, the alleged invention relates to an apparatus for endovascularly replacing a
`heart valve. The apparatus claimed by independent claim 1 of the opposed patent
`includes an expandable anchor (feature group 1) and a fabric seal (feature group 2).
`
`6.
`
`According to feature 2.a) of claim 1, the seal extends from the distal end of the valve
`
`(20) proximally over the anchor in the delivery configuration.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 3 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 3 of 56
`
`

`

`Bird 8: Bird
`
`17 March 2016
`page 4
`
`Feature 2.a) is interpreted to the effect that the seal extends proximally from the distal
`
`end of the valve, i.e. the valve being the reference for the extension of the seal.
`
`Added subject matter (Art. 1001c), 1611! and 1231 2) EPC)
`
`D.
`
`The opposed patent (EP 2 749 254 B1) was filed as a divisional of EP 1 702 247, which
`is based on the PCT application W0 2005/062 980 A2 (hereafter: “W0i98o”,
`Exhibit BB2). The relevant description and the figures of the opposed patent as filed
`are identical. to the description and figures of WO ‘980. Therefore, in the following
`reference will be only made to the disclosure of WO ‘980 and Art 76(1) EPC. However,
`
`the exact same arguments and reasoning also applies for the opposed patent as
`
`originally filed and Art 123(2) EPC.
`
`In accordance with G 1/05 (OJ EPO 2008, 271) and G 1/06 (OJ EPO 2008, 307), it is a
`condition that anything disclosed in the granted patent must be directly and
`unambiguously derivable not only from the original application on which the patent
`has been granted, but also from what was disclosed in each of the preceding
`applications as filed. Accordingly, the subject matter claimed in the granted claims of
`the opposed patent must also be disclosed in WO’980 (Art 76(1) EPC).
`
`10.
`
`11.
`
`In T 219/09 the board of appeal of the EPO held that, according to established case
`law, it will normally not be allowable to base an amended claim on the extraction of
`isolated features from a set of features originally disclosed only in combination, e.g. a
`
`specific embodiment in the description (intermediate generalization).
`
`is only exceptionally
`Omitting features that are originally disclosed in context
`permissible in the absence of any clearly recognizable functional or structural
`relationship among the features of the specific combination originally disclosed
`(cf. decision T 1067/97) and if the omitted feature is not inextricably linked with those
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 4 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 4 of 56
`
`

`

`Bird 8: Bird
`
`17 March 2016
`page 5
`
`features (cf. decision T 714/00). This is not the case here and the claims as granted are
`
`an intermediate generalisation of the disclosure of WO’980.
`
`I.
`
`General Remarks
`
`12.
`
`In WO’980 a heart valve prosthesis is disclosed e.g. in Fig 107C, where the fabric seal
`
`is disclosed to bunch up in the deployed configuration (page 85, 11. 28-29). This
`
`Fig 1070 is pictured below:
`
`70
`
`
`
`13.
`
`The heart valve prosthesis shown above is substantially similar to the prosthesis
`marketed by the patentee as the so-called Lotus Valve. This valve looks as follows as
`may
`be
`taken
`from
`the
`homepage of
`Boston
`Scientific
`(http: //www.bostonscientific.c0m/en—US/products/transcatheter-heart—valve/lotus-
`
`valve-system.htrnl) :
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 5 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 5 of 56
`
`

`

`Bird & Bird
`
`17 March 2016
`page 6
`
`
`
`14.
`
`The heart valve prosthesis disclosed in WO‘980 is a very specific type of heart valve
`prosthesis and the components of this prosthesis are all required in order for the heart
`valve to function properly. The required features,
`including repositionable self—
`expanding frame, active foreshortening of the anchor using actuators, a locking-
`mechanism to maintain the diameter of the foreshortened anchor and additional
`
`features are disclosed as essential for the function of the apparatus as claimed.
`
`15.
`
`The patentee, however, left out numerous essential features in claim 1 that are
`disclosed in the description of WO’980 to stand in clear functional and structural
`
`context with the features specified in claim 1 as granted.
`
`(1)
`
`16.
`
`The introduction part on pages 1-4 of WO’980 sets out which technical problems are
`present in the devices of the prior art. The general part of the description then
`discloses which features of the claimed apparatus allegedly overcome these problems.
`
`17.
`
`First of all, the introductory part of WO’980 (page 3, 11. 21-24) discloses:
`
`“While providing for an aortic approach, devices described in the Garrison
`patent application sufferfrom several drawbacks. First, the stent portion of the
`device is delivered across the native valve as a single piece in a single step,
`which precludes dynamic repositioning of the stent during delivery.”
`[emphasis added]
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 6 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 6 of 56
`
`

`

`Bird 8: Bird
`
`17 March 2016
`page 7
`
`18.
`
`Indeed it
`
`is described throughout
`
`the specification that
`
`the apparatus
`
`is
`
`repositionable, starting already with the title of WO’980 reading “REPOSITIONABLE
`
`HEART VALVE” and including more than 40 instances of
`
`“
`
`reposition” or
`
`“repositioning”.
`
`19.
`
`Thus, the feature of the apparatus to be repositionable is a core element of the
`
`technology disclosed in the opposed patent. Accordingly, the apparatus claimed in the
`
`opposed patent must be repositionable, which is an essential feature that has been
`
`omitted from claim 1.
`
`(2)
`
`20. A further problem of the prior art devices is disclosed on page 2, 11. 11-13 of WO,’980,
`
`namely the relatively large cross-sectional delivery profile of prior art stent valves:
`
`‘iAnother drawback of the PVT device is its relatively large cross-sectional
`delivery profile. The PVT system's stent/valve combination is mounted onto a
`delivery balloon, making retrograde delivery through the aorta challenging.”
`
`[emphasis added]
`
`21. Accordingly, the description teaches in the context of the diameter of the apparatus
`
`(W0’98o, page 23,11. 1-14) that:
`
`“[...] in order to avoid delivery of anchor 30 on a balloonfor balloon expansion,
`a non-hydraulic or non—pneumatic anchor actuator is used.“
`
`[emphasis added]
`
`22.
`
`In other words, leaving out the balloon solves the problem of a relatively large device
`
`diameter. Thus, as will be further outlined in more detail also below, the apparatus
`
`must include a non—hydraulic or non—pneumatic anchor actuator, which is another
`
`essential feature that has been omitted from claim 1.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 7 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 7 of 56
`
`

`

`Bird & Bird
`
`17 March 2016
`page 8
`
`(3)
`
`23.
`
`A further problem to be solved is disclosed on page 3, 11. 3—5 of WO’980, namely that
`
`anchoring of prior art valve stents t0 the vessel walls is problematic:
`
`“However when the stent has a valve fastened inside it, as is the case in aortic
`valve replacement, the anchoring of the stent to vessel walls is significantly
`challenged during diastole.”
`
`[emphasis added]
`
`24.
`
`Accordingly, WO’980 (page 9,11. 1-5) discloses that this problem is solved by including
`
`leaflet engagement elements:
`
`“The expandable anchor filrther includes a leaflet engagement element on its
`proximal end to engage the leaflets of the patient’s heart valve. [...] Moreover,
`once engaged, the leaflet engagement element prevents the distal movement of
`the anchor.”
`
`[emphasis added]
`
`25.
`
`Consequently, the apparatus must include a leaflet engagement element in order to
`prevent movement of the anchor, yet another essential feature that has been omitted
`from claim 1.
`
`(4)
`
`26.
`
`A further problem to be solved is mentioned on page 2, 11. 29-30 and page 3, 11. 9—11 of
`
`WO’980 that the prior art devices lack radial strength:
`
`“Another drawback of prior art self—expanding replacement heart valve
`systems is their lack of radial strength.”
`
`‘Moreover, a self-expanding stent without sufficient radial force will end up
`dilating and contracting with each heartbeat, thereby distorting the valve,
`aflecting itsfunction and possibly migrating and dislodging completely.”
`
`[emphasis added]
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 8 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 8 of 56
`
`

`

`Bird 8: Bird
`
`17 March 2016
`page 9
`
`27.
`
`In the context of the radial force exerted by the stent, page 3, 11. 5—6 of WO’980 teaches
`
`that it is important that the valve stent must prevent blood from flowing back into the
`
`inside of the ventricle. In other words, the valve stent must have sufficient strength to
`
`provide a good sealing property to avoid regurgitation:
`
`“The force to hold back arterial pressure and prevent blood from going back
`inside the ventricle during diastole will be directly transferred to the
`stent/vessel wall interface. Therefore the amount of radial force required to
`keep the self—expanding stent/valve in contact with the vessel wall and not
`sliding will be much higher than in stents that do not have valves inside of
`them.”
`
`28.
`
`This problem is solved by providing an anchor that is actuated using an external non-
`hydraulic or non—pneumatic force to actively foreshorten the anchor. Page 23, ll. 1—2 of
`
`WO’980 discloses:
`
`“Anchorgo may be actuated using external non-hydraulic or. non-pneumatic
`force to activer foreshorten in order to increase its radial strength.”
`
`[emphasis added]
`
`29.
`
`The fact, that an active foreshortening of the anchor is required to increase radial
`
`strength is further disclosed on page 11, 11. 12—16 of WO’980:
`
`“Another aspect of the invention provides an apparatus for endovascularly
`replacing a patient’s heart valve, including: an anchor having a collapsed
`delivery configuration and an expanded deployed configuration; and a
`replacement valve coupled to the anchor, wherein the anchor comprises
`enhanced radial strength in the expanded deployed configuration as compared
`to the collapsed delivery configuration due to imposed foreshortening.”
`
`[emphasis added]
`
`30.
`
`Therefore, the apparatus must additionally include that the non-hydraulic or non—
`pneumatic actuator actively foreshortens the apparatus during deployment, which is
`another essential feature that has been omitted from claim 1.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 9 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 9 of 56
`
`

`

`Bird 8: Bird
`
`17 March 2016
`page 10
`
`(5)
`
`31. On page 4, 11. 1-3 of WO’98o it is further emphasized that the apparatus of the claimed
`invention allegedly solves fl those drawbacks mentioned in the context of the prior
`art:
`
`“In view of drawbacks associated with previously known techniques for
`percutaneously replacing a heart valve,
`it would be desirable to provide
`methods and apparatus that overcome those drawbacks.”
`
`Thus, all features discussed above are clearly essential features of the claimed
`apparatus based on the general description alone. But there are in fact numerous
`further additional features disclosed that are required and essential for the function of
`
`the claimed apparatus which becomes clear in the context of the disclosure of the
`
`specification as a whole and will be explained in the following.
`
`II.
`
`Features omitted in the context of the anchor
`
`(1)
`
`Active foreshortening of anchor with actuators
`
`32.
`
`The foreshortening of the anchor is only disclosed as an active foreshortening of the
`anchor using actuators as is further specified with respect to Figure 107. This follows
`
`from the disclosure on page 85, 11. 26—28 of WO’980, which reads:
`
`“Next, Figure 107C, as the apparatus is actively toreshortened using proximal
`(e.g., fingers) and/or distal actuators
`(e.g., elements 55),
`the leaflet
`engagement elements positively register with the native valve leaflets.”
`
`[emphasis added]
`
`33-
`
`Thus, in the context of the claimed device only an active foreshortening of the anchor
`
`using actuators is disclosed.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 10 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 10 of 56
`
`

`

`Bird 8: Bird
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`17 March 2016
`page 11
`
`34.
`
`Furthermore, an active foreshortening is required to provide the stent with sufficient
`
`radial strength. To this end, WO’980 discloses on page 23, 11. 1-2:
`
`“Anchor 30 may be actuated using external non—hydraulic or non—pneumatic
`force to activelyforeshorten in order to increase its radial strength.”
`
`is expressly mentioned in the
`35. That the increase in radial strength is essential
`introductory section on page 2,11. 29—30 of WO’980. That the radial strength, achieved
`
`by an active foreshortening of the anchor by actuators, is a requirement also for the.
`
`sealing function is explained on page 27, 11. 3—5 of WO’980 as follows:
`
`“Once properly aligned, actuators 50 are retracted relative to actuators 60 to
`impose foreshortening upon anchor 30 and expand apparatus 10 to the fully
`deployed configuration, as in Figure 5D. Foreshortening increases the radial
`strength ofanchor 30 to ensure prolonged patency ofvalve annulus An, as well
`as to provide a better seal for apparatus 10 that reduces paravalvular
`regurgitation. As
`seen
`in Figure
`5E,
`locks 40 maintain
`imposed
`foreshortening.”
`
`[emphasis added]
`
`36. Thus, the essential feature that the anchor must include actuators in the delivery
`configuration to be actively foreshortenable for deployment has been omitted from
`
`claim 1 as granted.
`
`37.
`
`The patent application as originally filed defines the degree of foreshortening by
`referring to the ratio of deployed length to collapsed/delivery length (cf. BB2, page 50, ’
`
`11. 7—8). The smaller this ratio gets the greater the degree of foreshortening.
`
`38. The claimed apparatus is allegedly based on figures 32-34 and 107 and the respective
`description in the patent application as originally filed. However, every apparatus that
`is disclosed foreshortens significantly, namely by a ratio of 0.5 or below. When
`measured, the ratio of the deployed to collapsed lengths shown in originally filed
`figures 107 B/C, 32 and 33 is in each case about 0.4. Also the description does not
`disclose any foreshortening ratios above 0.5 (cf. BB2, page 50,11. 7-8).
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 11 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 11 of 56
`
`

`

`Bird 8: Bird
`
`17 March 2016
`page 12
`
`'
`
`39-
`
`Thus, it has also been omitted from claim 1 as granted that the anchor foreshortens
`
`significantly, namely by a ratio of the deployed to collapsed lengths of 0.5 or below.
`
`Non-hydraulic or non-pneumatic anchor actuators
`
`(2)
`
`4o.
`
`Additionally, the description does not allow the use of any actuator but requires the
`
`use of specific actuators, namely non—hydraulic or non—pneumatic anchor actuators.
`
`41.
`
`On page 21, 11. 25-32 WO’980 discloses that a deployment tool is used to place the
`apparatus of the alleged invention by applying a non-hydraulically expanding or non-
`
`pneumatically expanding force on the anchor:
`
`invention relates to apparatus (...) for endovascularly or
`“The present
`percutaneously delivering and deploying a prothesis, e.g., an aortic prosthesis,
`(...). A delivery system and/or deployment tool is provided including a sheath
`assembly and a guidewirefor placing the prosthetic apparatus endovascularly
`within the patient and a user control allowing manipulation of the prosthetic
`apparatus from external to the patient through the application at a non—
`h draulicall
`e
`andin
`or
`non— neumaticall
`e
`andin
`orce on the
`anchor.”
`
`[emphasis added]
`
`42.
`
`This force applied by the deployment tool obviates the use of a balloon. This is
`
`disclosed e.g. page 23, 11. 12-14 of WO’980:
`
`“A deployment tool is used to actuate, reposition, lock and/or retrieve anchor
`30. In order to avoid delivery of anchor 30 on a balloonfor balloon expansion,
`a non-hydraulic or non—pneumatic anchor actuator is used.”
`
`43.
`
`is also required to actively
`tool/actuator
`the mentioned deployment
`Further,
`foreshorten the anchor. In this connection, the specification of WO’980 discloses on
`
`page 85, 11. 26-28 that the active foreshortening is effected by using proximal and
`distal actuators:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 12 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 12 of 56
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`

`

`Bird & Bird
`
`17 March 2016
`page 13
`
`“Next, Figure 107C, as the apparatus is actively toreshortened using proximal
`Leg,
`fingersZ andgor distal actuators
`(e.g., elements 55),
`the leaflet
`engagement elements positively register with the native valve leaflets.”
`
`,
`
`[emphasis added]
`
`44.
`
`Accordingly, Figure 107 shows this essential feature of the actuators in the context of
`
`the apparatus as claimed.
`
`45.
`
`In the absence of an anchor configured to be controlled by proximal (e.g., fingers)
`
`and/or distal actuators there would be no active foreshortening of the anchor.
`
`Accordingly, a further essential feature has been inadmissibly left out from the claims
`of the opposed patent, namely that the active foreshortening of the anchor is effected
`
`by the use of non-hydraulic or non—pneumatic proximal and/or distal actuators.
`
`.
`
`(3)
`
`Lockable anchor and locks
`
`47.
`
`The anchor of the claimed apparatus must be actively foreshortenable as outlined
`
`above. However, the active foreshortening of the anchor alone is not sufficient for the
`
`apparatus to function properly. Instead, the foreshortened condition of the anchor,
`which follows from an active foreshortening, also needs to be maintained.
`
`This maintenance of the imposed foreshortening is achieved by using a lockable
`
`anchor, which is disclosed on page 11, 11. 16-18 of WO’980 as follows:
`
`“The apparatus may include a locking mechanism [or maintaining imposed
`toreshortening, and it may be configuredfor retrieval prior to actuation of the
`locking mechanism.”
`
`[emphasis added] .
`
`49.
`
`The fact, that a lockable anchor is an essential feature is further confirmed by WO’980
`
`in the section explaining the use of the claimed apparatus. By referring to Figure 107,
`
`WO’980 discloses on page 85, 11. 32-34:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 13 of 56
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 13 of 56
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`

`

`Bird 8: Bird
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`17 March 2016
`page 14
`
`“Once the anchor is fully compressed within the aortic valve, the anchor is
`
`locked the fingers and post mandrels are disengaged, and the seal is adapted
`tofurther limit bloodflow around the replacement valve.”
`
`[emphasis added]
`
`50. Thus, the deployed state can only be maintained by locking the foreshortened state of
`
`the anchor. Thus, the lockability of the anchor is an essential element of the claimed
`
`apparatus as well.
`
`51.
`
`In order for the anchor to be lockable it must comprise locks which maintain the
`
`foreshortened shape of the anchor. This is disclosed by WO’980 on page 27, 11. 3-5:
`
`“Once properly aligned, actuators 50 are retracted relative to actuators 60 to
`impose toreshortening upon anchor 30 and expand apparatus 10 to the fully
`deployed configuration, as in Figure 5D. Foreshortening increases the radial
`strength ofanchor 30 to ensure prolonged patency ofvalve annulus An, as well
`as to provide a better seal for apparatus 10 that reduces paravalvular
`regurgitation. As
`seen
`in Figure
`5E,
`locks 40 maintain imposed
`toreshortening. ”
`
`[emphasis added]
`
`52.
`
`The respective locks are described by WO’980 on page 26, 11. 8-14 with reference to
`
`Figure 5E and to Figures 4D-4F as follows:
`
`“In Figure 4D, continuedforeshortening causes male interlocking elements 44
`of locks 40 to engagefemale interlocking elements 42. The male elements mate
`with the female elements, thereby locking apparatus 10 in the foreshortened
`configuration, as seen in Figure 4E. Actuators 50 are then pulled through
`eyelets 45 of male elements 44 to remove the actuatorsfrom apparatus 10, and
`actuators 62 are pulled through the proximal end of anchor 30 to uncouple
`actuators 60from the apparatus, thereby separating delivery system 100from '
`apparatus 10. Fully deployed apparatus 10 is shown in Figure 4F.”
`
`53.
`
`Similarly, WO’980 (page 48, 11. 28—31) provides by reference to Figures 49B, 50B and
`
`50C:
`
`“Anchor 30 comprises a plurality of anchor lock elements 34, e.g., buckles 34,
`attached to its proximal region, onefor each post 32. Posts 32 may comprise a
`lock element that forms a two—part
`locking mechanism with anchor lock
`
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`17 March 2016
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`elements 34 for maintaining anchor 30 in a deployed or expanded
`configuration (e.g., as illustrated in Figures 493, 503 and 50C).”
`
`54.
`
`As follows from the above passages of WO’980, the claimed apparatus must be
`
`equipped with both, a lockable anchor and locks, which, therefore, both are essential
`
`features of the apparatus according to the teaching of opposed patent.
`
`(4)
`
`Self-expandable anchor
`
`55.
`
`Using a self—expandable anchor relates to a problem stated in the introductory part of
`WO’980, namely to reduce the cross—sectional delivery profile of the apparatus. This is
`
`achieved by means of a self-expandable anchor since an increase in diameter due to
`
`the extra space that would be required by a balloon can be avoided.
`
`The need to eliminate the use of a balloon for delivery of the anchor is set out on
`
`page 23, 11. 12—14 of WO’980 as follows:
`
`“A deployment tool is used to actuate, reposition, lock and/or retrieve anchor
`30. In order to avoid delivery of anchor 30 on a balloon for balloon expansion,
`a non-hydraulic or non-pneumatic anchor actuator is used.”
`
`[emphasis added]
`
`57-
`
`Thus, the configuration of the anchor needs to allow a delivery of the anchor by means
`of a non-hydraulically expanding or non—pneumatically actuator instead of a balloon
`catheter as already set out above. However, this is not the entire disclosure on the
`deployment of the anchor. It is additionally disclosed in relation to Figures 107A—107C
`on page 84, line 34 — page 85, line 2 that:
`I
`
`“As the sheathing catheter is pulled proximally out of the native valve, anchor
`30 and replacement valve 20 become unsheathed. Immediately the portion of
`the unsheathed anchor 30 dynamically self—expands (...).”
`
`Accordingly, it is also an essential feature that the anchor is self—expandable.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 15 of 56
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`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 15 of 56
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`17 March 2016
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`(5)
`
`Repositionable and retrievable anchor
`
`59-
`
`The steps shown in Figures 107A-107C reflect what
`
`is also disclosed in the
`
`specification of WO’980 on page 23, 11. 12—14:
`
`“A deployment tool is used to actuate, reposition, lock and/or retrieve anchor
`30. In order to avoid delivery of anchor 30 on a balloon for balloon expansion,
`a non—hydraulic or non—pneumatic anchor actuator is used.”
`
`6o.
`
`Also in Figure 107 such a deployment tool is used. Thus, the anchor 30 must be
`
`configured to be used with actuators in order to be repositionable. This type of anchor
`
`is used throughout the description.
`
`61.
`
`Furthermore, the heart valve prosthesis is only repositionable with the actuators until
`
`the device is locked. Thus,
`
`the locks are also required in conjunction with a
`
`repositionable valve prosthesis once the correct position has been reached (see also
`
`comments above concerning the requirements for locks).
`
`62.
`
`The anchor is only repositionable if it is also retrievable. Thus, it is an essential feature
`
`that the anchor is also retrievable and repositionable.
`
`(6)
`
`Anchor posts on the inside
`
`The anchor must comprise posts on the inside also because the valve needs to be
`
`attached to the posts there. In this context, WO’980 discloses on page 22, 11. 31-33:
`
`“Annular base 22 of replacement valve 20 preferably is coupled to skirt region
`34 of anchor 30, while commissures 24 of replacement valve leaflets 26 are
`coupled to posts 38.”
`
`As shown in Figure 1 of WO’980, posts 38a, 38b and 38c are attached to the anchor.
`Further embodiments of posts are shown in Figure 18 and Figures 50-62 of WO’980.
`
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`As such, posts are an essential element and are required for an active foreshortening
`
`of the anchor.
`
`65. According to WO’980 the active foreshortening achieved by the anchor posts and
`
`actuators in turn is required to create a seal. This is disclosed for example on page 27,
`
`11. 1—6:
`
`“During foreshortening, actuators 60 push against lip region 32 of anchor 30,
`while actuators 50 pull on posts 38 of the anchor. Once properly aligned,
`actuators 50 are retracted relative to actuators 60 to impose foreshortening
`upon anchor 30 and expand apparatus 10 to the fiilly deployed configuration,
`as in Figure 5D. Foreshortening increases the radial strength of anchor 30 to
`ensure prolonged patency of valve annulus An, as well as to provide a better
`§e_alfor apparatus 10 that reduces paravalvular regurgitation.”
`
`[emphasis added]
`
`66.
`
`Posts are also disclosed in the Figures of WO’980 showing the claimed apparatus. For
`
`example in Figure 1073 which is pictured below, one post of the anchor is marked by
`an arrow.
`
`
`
`FIG. 107B
`
`67. With respect to the embodiments shown in Figures 107A —107C the specification of
`
`WO’980 (page 85, 11. 32-34) further discloses:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 17 of 56
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`“Once the anchor is fully compressed within the aortic valve, the anchor is
`
`locked the fingers and post mandrels are disengaged, and the seal is adapted
`tofurther limit bloodflow around the replacement valve.”
`
`[emphasis added]
`
`68.
`
`Since the posts comprise the locking mechanism which is essential to maintain an
`
`imposed foreshortening and the radial strength of the anchor (see also WO’980,
`
`page 23, 1. 1-2), the posts themselves must be considered as essential elements. This is
`
`further supported by Figures 50—53 of WO’980, which show anchor posts having a
`
`lock alignment feature (see also WO’980, page 18, l. 26 through page 19, l. 3 and point
`
`3 above).
`
`Besides, the posts cannot be located anywhere, but must be attached on the inside of
`
`the anchor as for instance shown in Figure 1073 pictured above. The specification of
`
`WO’980 (page 22,11. 17-19) discloses:
`
`“Anchor 30 has a lip region 32, a skirt region 34 and a body region 36. First,
`second and third posts 38a, 38b and 380, respectively, are coupled to skirt
`region 34 and extend within lumen 31 of anchor 30.”
`
`7o.
`
`In addition, the valve leaflets are coupled to the posts, which is only possible if the
`
`posts are attached to the inside the anchor (cf. WO’980, page 22, 11. 32-33, page 48,
`
`11. 19-24).
`
`71.
`
`Thus, anchor posts attached on the inside of the anchor are an essential feature of the
`
`apparatus as claimed.
`
`(7)
`.
`Leaflet engagement element of anchor
`
`72.
`
`The essential feature of the leaflet engagement elements addresses the problem set out
`
`in the introduction of WO’980 to effectively anchor the stent to prevent migration and
`
`to decrease the risk of blocking the coronary ostia (cf. WO’980, page 3, 11. 3-6, 11. 28-
`
`30, page 3,11. 26-30).
`
`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 18 of 56
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`Edwards Lifesciences Corporation, et al. Exhibit 1148, Page 18 of 56
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`73-
`
`The anchor must also comprise a leaflet engagement element to prevent the distal
`
`movement of the anchor. In this context, WO’98