`
`'
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`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-Eenthem-Platz 1
`80469 Munchen
`
`Dr. Daniela Kinkeldey
`Dr. Michael Alt
`Ext: +49 (0) 89 3581 6229
`daniela.kinkeldey@twobirds.com
`michael.alt@twobirds.com
`
`Munich, 23 June 2016
`
`Our ref. (please always state): EDWLI.0056
`
`The facts and arguments (point VII) for the
`
`OPPOSITION
`
`filed in the name and on behalf of Edwards Lifesciences LLC, 1 Edwards Way Irvine, CA
`
`92614, against the European patent EP 2 926 766 B1 entitled “Repositionable heart valve”
`
`(European patent application No. 15 167 832.3) of Boston Scientific Scimed, Inc., One
`
`Scimed Place, Maple Grove, MN 55311-1566 / US are presented in the following:
`
`The opposition fee is to be debited from our account 28002046.
`
`A.
`
`Requests
`
`It is requested to revoke the patent in its entirety, based on the grounds that:
`
`its subject-matter is not patentable within the terms of Arts. 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. 1oo(b) EPC, Art. 83 EPC); and
`
`the subject-matter of the opposed patent extends beyond the content of the
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 1 of 50
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`In accordance with the Guidelines for Examination, Part E, Section VII, Point 4
`accelerated processing is requested since an infringement action in respect of the
`European patent is pending before the regional court of Dusseldorf, Germany (current
`case number 4a 0 28/16).
`
`III. Oral proceedings pursuant to Art. 116 EPC are requested.
`
`B.
`
`References
`
`Feature analysis of claim 1
`
`BB2 WC 2005/062980 A2 (PCT application of opposed patent)
`
`EP 1 702 247 (parent application)
`
`BB4 WO 02/36048 A1 (“Seguin I”)
`
`BB4A AU 2002212418 B2 (certified translation of BB4)
`
`BB5 W0 03/003949 A2 (“Seguin II”)
`
`US 5,957,949 (“Leonhardt”)
`
`US 2001/0027338 A1 (“Greenberg”)
`
`US 6,015,431 (“Thornton”)
`
`BB9 W0 03/ 037222 (“Lawrence Brown“)
`
`BB10 US 10/746,280 (priority application of opposed patent)
`
`BB11 US 6,729,356 Bl (“Baker”)
`
`BB12 US 2004/082989 A1 (“Cook”)
`
`BB13 US 5,693,088 (“Lazarus”)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 2 of 50
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`Feature analysis of claim 1 and the alleged invention
`
`C.
`
`The opposed patent comprises 17 claims including independent claim 1. All claims
`
`relate to an apparatus for endovascularly replacing a patient’s heart valve.
`
`Below is a feature analysis of independent claim 1:
`
`Apparatus for endovascularly replacing a patient's heart valve,
`
`the apparatus
`
`comprising:
`
`an expandable cylindrical anchor (30)
`
`La) supporting a replacement valve (20),
`
`1b) the anchor (30) having a delivery configuration and a deployed configuration,
`
`at least one sac (200)
`
`2.a) disposed about the exterior of the anchor (30)
`
`2.b) to provide a seal.
`
`The above feature analysis is enclosed as a separate document (Exhibit BB1).
`
`Added subject-matter {Art 1001c), 1611) and 12312) EPC!
`
`D.
`
`The opposed patent (EP 2 926 766 Bl) had been filed as a divisional of EP 1 702 247,
`
`which is based on the PCT application WO 2005/062980 A2 (hereafter: “WO ’980”,
`
`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
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 3 of 50
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`23 June 2016
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`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 W0 ’980 (Art. 76(1) EPC).
`
`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).
`
`Omitting features that are originally disclosed in context
`
`is only exceptionally
`
`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
`
`features (cf. decision T 714/00).
`
`1.
`
`General Remarks
`
`In W0 ’980 a heart valve prosthesis is disclosed e.g. in Figs. 5A — I and in particular in
`
`Fig. 5F, which shows sacs (200). This figure is pictured below:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 4 of 50
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`23 June 2016
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`
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`10. However,
`
`the patentee left out numerous essential
`
`features disclosed in the
`
`description of WO ’980 which stand in clear functional and/or structural context With
`
`the features specified in claim 1 as granted, resulting in an inadmissible intermediate
`
`generalization.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 5 of 50
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`(1)
`
`The introduction part on pages 1-4 of WO ’980 sets out which technical problems are
`
`created by the devices of the prior art. The general part of the description then
`
`discloses which features of the claimed apparatus allegedly overcome these problems.
`
`First of all, the introductory part on page 3, 11. 21-24 discloses:
`
`“While providing for an aortic approach, devices described in the Garrison
`patent application sufi'erfrom several drawbacks. First, the stent portion of the
`device is delivered across the native value as a single piece in a single step,
`which precludes dynamic repositioning of the stent during delivery.”
`
`[emphasis added]
`
`Indeed it is described throughout the entire specification that the apparatus must be
`
`repositionable, starting already with the title of WO ’980 reading “REPOSITIONABLE
`
`HEART VALVE” and including more than 40 instances of “reposition” or
`
`“repositioning”.
`
`Thus, the feature that the apparatus must 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 — an essential feature that has been omitted
`
`from claim 1 as granted.
`
`(2)
`
`A further problem of the prior art devices is disclosed on page 2, 11. 11-13, namely the
`
`relatively large cross-sectional delivery profile of prior art stent valves:
`
`“Another 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]
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 6 of 50
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`Accordingly, the description teaches in the context of the diameter of the apparatus
`
`(cf. page 23, 11. 1-14) that
`
`“in order to avoid delivery of anchor 30 on a balloon for balloon expansion, a
`non-hydraulic or non-pneumatic anchor actuator is used.“
`
`In other words, leaving out the balloon solves the problem of a relatively large
`
`diameter.
`
`Thus, the apparatus must include a non-hydraulic or non—pneumatic actuator —
`
`another essential feature that has been omitted from claim 1 as granted.
`
`(3)
`
`A further problem to be solved is disclosed on page 3, 11.3—5 that the anchoring of
`
`prior art valve stents to 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 ot the stent to vessel walls is significantly
`challenged during diastole.”
`
`[emphasis added]
`
`Accordingly, page 9, 11. 1—5 discloses that this problem is solved by including leaflet
`
`engagement elements:
`
`“The expandable anchor further 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.”
`
`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.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 7 of 50
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`(4)
`
`21. A further problem to be solved is mentioned on page 2, 11. 29-30 and page 3, 11.9—11
`
`that the prior art devices lack radial strength:
`
`“Another drawback of prior art self—expanding replacement heart valve
`systems is their lack of radial strengt .”
`
`“Moreover, a self-expanding stent without suficient 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]
`
`In the context of the radial force on page 3, 11. 5-6 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 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.”
`
`23. 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, 11. 1-2 of
`
`WO ’980 discloses:
`
`“Anchor 30 may be actuated using external non-hydraulic or non-pneumatic
`(force to actively foreshorten in order to increase its radial strengt .”
`
`[emphasis added]
`
`24. The fact that 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
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 8 of 50
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`delivery configuration and an expanded deployed configuration; and a
`replacement value 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]
`
`Therefore, the apparatus must additionally include non—hydraulic or non—pneumatic
`
`actuators that actively foreshorten the apparatus during deployment in order to
`
`achieve enhanced radial strength — a further essential feature that has been omitted
`
`from claim 1 as granted.
`
`(5)
`
`On page 4, 11.1-3 of WO ’980 it is emphasized that the apparatus of the alleged
`
`invention solves all 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
`
`The anchor must be actively foreshortenable with actuators
`
`(1)
`
`An active foreshortening of the anchor is also required to provide the stent with
`
`sufficient radial strength. W0 ’980 discloses on page 23, 11. 1—2:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 9 of 50
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`“Anchor 30 may be actuated using external non-hydraulic or non-pneumatic
`force to activelyforeshorten in order to increase its radial strengt .”
`
`29. That the increase in radial strength is essential
`
`is expressly mentioned in the
`
`introductory section on page 2, 11.29—30 of WO ’980. This radial strength is only
`
`achieved by an active foreshortening of the anchor by actuators and is also a
`
`requirement for the sealing function as 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 toreshortening upon anchor 30 and expand apparatus 10 to the fully
`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 seal for apparatus 10 that reduces paravalvular
`regurgitation. As
`seen
`in Figure
`5E,
`locks 40 maintain imposed
`foreshortening. ”
`
`[emphasis added]
`
`As disclosed on page 32, 11. 30-31, compliant sacs 200 are disposed about the exterior
`
`of anchor 30 to provide a “more efficient sea ”:
`
`“Compliant sacs 200 may be disposed about the exterior of anchor 30 to
`provide a more efi’icient seal along irregular interface I.”
`
`Thus, the description discloses that the apparatus described must already have sealing
`
`means even without the sacs. The sealing quality is then allegedly further improved by
`
`adding the sacs. Accordingly, the apparatus must further be configured to actively
`
`foreshorten by use of actuators to provide a seal which is then allegedly further
`
`improved by the sacs.
`
`Thus, actuators are also shown in the context of figure 5 showing anchor 30, sacs 200
`
`and actuators 50, 60 (see also W0 ‘980, page 27, first sentence).
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 10 of 50
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`Thus, the essential feature that the anchor must include actuators in the delivery
`
`configuration to actively foreshorten for deployment has been omitted from claim 1 as
`
`granted.
`
`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.
`
`The claimed apparatus is inter alia based on figure 5 and the respective description in
`
`the patent application as originally filed. However, every apparatus that is disclosed in
`
`the context of a device comprising sacs 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 figure 5 (figures 5F and 5C) is about 0.4. Also the description does not
`
`disclose any foreshortening ratios above 0.5 (cf. BB2, page 50,11. 7-8).
`
`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)
`
`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.
`
`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 guidewire for placing the prosthetic apparatus endovascularly
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 11 of 50
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`apparatus from external to the patient through the application of a non-
`h draulicall
`e
`andin
`or non- neumaticall
`e
`andin
`orce on the
`anchor.”
`
`[emphasis added]
`
`39. This force applied by the deployment tool obviates the use of a balloon. This is
`
`disclosed on 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 balloon for balloon expansion,
`a non—hydraulic or non-pneumatic anchor actuator is used.”
`
`Accordingly, a further essential feature has been inadmissibly left out from granted
`
`claim 1 of the opposed patent, namely that the active foreshortening is effected by the
`
`use of non-hydraulic or non—pneumatic anchor actuators.
`
`(3)
`
`Lockable anchor and locks
`
`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 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 for maintaining imposed
`foreshortening, and it may be configuredfor retrieval prior to actuation of
`the locking mechanism.”
`
`[emphasis added]
`
`That this essential feature is required for the apparatus as claimed is also confirmed in
`
`Fig. 15A, relating to the use of sacs, which details the apparatus (10), the sacs (200)
`
`and the locks (see arrow):
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 12 of 50
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`44. The locks shown in Fig. 15A comprise male interlocking elements 44, eyelets 45 and
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`triangular shaped female interlocking elements 42' as further shown in more detail in
`
`Fig. 11A:
`
`40'\44
`
`45/40'
`
`42'
`
`O
`
`38
`
`FIG //.4
`
`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 of anchor 30 to ensure prolonged patency of valve 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]
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 13 of 50
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`46. As follows from the above passage 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
`
`47. 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.
`
`48. 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]
`
`49. 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 Figure 5 on page
`
`26, lines 23-25 that:
`
`“Apparatus 10 is deployed from lumen 112 of sheath 110, for example, under
`fluoroscopic guidance, such that anchor 30 of apparatus 10 dynamically self-
`expands to a partially deployed configuration, as in Figure 5C.”
`
`50. Accordingly, it is also an essential feature that the anchor is self-expandable. In fact, it
`
`is indispensable that the anchor is self—expandable also because the apparatus must be
`
`repositionable (see point 6 below).
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 14 of 50
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`(5)
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`Anchor must comprise barb elements
`
`In all figures shown in the opposed patent, such as Figs. 5F, 6F, 13 and 15, the anchor
`
`comprises barb elements 37. These barb elements are marked as small “X” shaped
`
`items as shown for example in figure 15A:
`
`
`
`52. No disclosure is found in the specification that the barb elements can be omitted from
`
`embodiments that comprise sacs. Rather, the specification discloses that the barb
`
`elements are used to reduce paravalvular regurgitation (cf. page 27, 11. 13—14). In
`
`accordance, all figures showing sacs (see figures 5F, 6F and 15) also show barb
`
`elements. Thus, the claimed apparatus is still lacking this essential feature which has
`
`been omitted during the examination proceedings when amending claim 1.
`
`(6)
`
`Repositionable anchor
`
`53. As outlined in the introduction, the apparatus must be repositionable. 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. Furthermore, the anchor must
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 15 of 50
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`be a self-expanding structure (see also above under point 4) since a balloon—
`
`expandable plastically deformable structure would not be readily retractable and
`
`repositionable after it has been plastically deformed.
`
`The anchor is only repositionable if it is also retrievable. Thus, it is an essential feature
`
`that the anchor is also retrievable and repositionable.
`
`(7)
`
`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, W0 ’980 discloses on page 22, 11. 31-33:
`
`“Annular base 22 of replacement value 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 Fig. 1 of WO ’980, posts 38a, 38b and 38c are attached to the anchor.
`
`Further embodiments of posts are shown in Fig. 18 and Figs. 50-62 of WO ’980. As
`
`such, posts are an essential element and are required for an active foreshortening of
`
`the anchor.
`
`This context is disclosed in the general part of the description on page 25, 11. 9—10:
`
`“During foreshortening, actuators 60 push against lip region 32 of anchor 30,
`while actuators 50 pull on posts 38 of the anchor.”
`
`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,
`
`“During foreshortening, actuators 60 push against lip region 32 of anchor 30,
`while actuators 5o pull on posts 38 of the anchor. Once properly aligned,
`actuators 50 are retracted relative to actuators 60 to impose foreshortening
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 16 of 50
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`upon anchor 30 and expand apparatus 10 to the fully 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
`Mfor apparatus 10 that reduces paravalvular regurgitation.”
`
`[emphasis added]
`
`59. Accordingly, posts are also included in the figures showing the claimed apparatus. The
`
`end of one post is marked by an arrow in the above shown Fig. 15A.
`
`60. The posts are furthermore essential because they comprise the locking mechanism
`
`which is essential to maintain an imposed foreshortening and to maintain the radial
`
`strength (see also page 23, ll. 1 — 2).
`
`Last but not least, the posts cannot be at any location, but must be attached on the
`
`inside of the anchor, as is shown in Figs. 12C and 15A.
`
`62. Additionally, it is repeatedly pointed out that the valve leaflets are coupled to the
`
`posts, which is only possible if the posts are attached to the inside of the anchor
`
`(e.g. page 22,11. 32 — 33, page 48,11. 19 — 24).
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`63. Thus, anchor posts attached on the inside of the anchor are also an essential feature of
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`the apparatus as claimed.
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`(8)
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`External cover
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`64. Without an external cover, covering the anchor, even the attachment of sacs on the
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`outside at various heights would not prevent regurgitation from occurring in between
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`the sacs and through the anchor. Thus, a further essential feature also shown in the
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`figures (e.g. figures 6, 7 and 15) has been omitted from claim 1, namely that the anchor
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`must externally be covered by a sealing cover.
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`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 17 of 50
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`III.
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`Features omitted in the context of the valve
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`65. The valve must comprise commissures. Nothing else is shown in the figures (e.g. Figs.
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`12 and 13).
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`In addition, commissures are disclosed on page 22 of WO ’980 in the section defining
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`the valve 20. In this context WO ’980 (page 22, 11. 31-33) provides:
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`“Annular base 22 of replacement value 20 preferably is coupled to skirt region
`34 of anchor 30, while commissures 24 of replacement value leaflets 26 are
`coupled to posts 38.”
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`Further, the commissures are also required in View of a further essential feature,
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`namely the anchor posts (see above).
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`IV.
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`Features omitted in the context of the sacs
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`(1)
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`Sacs distributed at various heights
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`68. On page 32,
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`11. 23-28 W0 ’980 mentions the risk of paravalvular leakage or
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`regurgitation around the apparatus and explains with reference to figure 13 that this
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`leakage occurs through the gaps between the leaflets L and the anchor 30:
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`“With reference now to Figure 13, a risk of paravalvular leakage or
`regurgitation around apparatus of the present invention is described. (...) The
`surface of native valve leaflets L is irregular, and interface I between leaflets L
`and anchor 30 may comprise gaps where blood B may seep through.”
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`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 18 of 50
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`From figure 13 it is clearly visible that the gaps occur over the entire outer surface of
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`the anchor 30.
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`For this reason, all sacs disclosed in the specification cover a substantial portion on
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`the exterior of the anchor in order to provide not only a local, spot-like seal but a
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`“more efficient” seal along the entire irregular interface I (page 32, 11. 30—31 in
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`conjunction with Figs. 5F, 6F, 13 (showing the irregular interface between leaflets L
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`and anchor 30), 14 and 15). The sacs must therefore always be located at various
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`heights on the exterior of the anchor.
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`Sacs other than those located at various heights are not originally disclosed. Thus, the
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`subject-matter of claim 1 constitutes a non-disclosed intermediate generalization.
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`72. A failure to provide sacs at multiple heights on the outside of the device would
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`inevitably also result in a lack of enablement (Art 83 EPC - this is further outlined
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`below under the respective section), since the leakage would not be avoided in
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`accordance to the opposed patent.
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`(2)
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`Compliant sacs
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`73. The description only discloses compliant sacs (page 32, 11. 30-31). Non—compliant sacs
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`are nowhere disclosed, but are currently included within the scope of claim 1. Also for
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`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 19 of 50
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`this reason the subject-matter of granted claim 1 goes beyond the content of the
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`originally filed specification.
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`Inadmissible amendments to the dependent claims
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`V.
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`(1)
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`None of the dependent claims comprises all essential features that have been omitted
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`from claim 1 as granted (see above). Thus, each and every dependent claim also
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`violates Art. 76 EPC for the same reasons set out above for claim 1.
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`(2)
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`Claim 2 specifies that the at least one sac (200) is “adapted to” be filled with blood.
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`This claim is not originally disclosed for the following reasons:
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`First, the original disclosure with respect to sacs that can be filled with blood is found
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`on page 32, 11. 31-32 in the context of figure 14:
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`Thus, this embodiment requires interconnected tubing connecting the sacs 200.
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`Furthermore, nowhere is it mentioned that the sacs are “adapted” to be filled. Rather,
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`the disclosure on page 32 makes it clear that the sacs may in preferred embodiments
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`be filled with said appropriate material. In other words, in preferred embodiments the
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`sacs comprise said material.
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`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 20 of 50
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`Any alternative embodiments where blood is used to fill the sacs are disclosed only in
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`conjunction with very specific other features that are, however, missing from granted
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`claim 2 (such as ‘fish-scale’ slots 202 that may be back-filled with blood passing
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`through replacement valve or sacs that are open to lumen 31 of anchor 30 and can be
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`filled by blood washing past the sacs as the blood moves through apparatus 10 l.
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`Thus, claim 2 clearly represents a non-disclosed intermediate generalization.
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`(3)
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`Claim 3 is originally only disclosed in the context of further features in particular the
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`sacs having multiple openings to lumen 31, i.e. to the inside of the anchor (cf. BB2,
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`page. 33,11. 11-13).
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`This embodiment disclosed in the description is also the only one that could possibly
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`function (Art 83 EPC), since the blood can “wash past” the apparatus, i.e. move with
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`velocity only on the lumen side / inside of the prosthesis. The exterior side of the
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`apparatus is in direct contact with the blood vessel wall and on this exterior side the
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`blood will not “wash” over the surface.
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`(4)
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`Claim 4 specifies that the at least one sac (200) comprises one or more slots (202)
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`that can be used to back—fill the at least one sac with ambient blood passing through
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`the replacement valve (20).
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`It was omitted that the slots are shaped like fish scales as expressly mentioned in the
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`description (page 33, ll. 9-10) and as shown in Fig. 16A, resulting in an impermissible
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`and non-disclosed generalization of the scope.
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`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 21 of 50
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`(5)
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`86. Claim 5 specifies that the at least one sac comprises one or more pores (204) that can
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`be used to fill the at least one sac (200).
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`87. However, the disclosure found in the description (page 33, 11. 10-11) only refers to “the
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`sacs comprise pores 204 that may be used to fill the sacs”. Thus, no embodiment is
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`disclosed wherein a single sac comprises pores nor where multiple sacs comprise a
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`single pore. Thus, the subject—matter of granted claim 5 referring to “at least one sac”
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`and “one or more pores” extends beyond the disclosed embodiment, in conflict with
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`Art. 76 EPC.
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`(6)
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`88. Claim 6 defines that the at least one sac (200) is adapted to provide a seal along an
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`irregular interface between the native valve leaflets and the anchor (30).
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`89. However, the respective disclosure in BB2 on page 32,11. 30—31 reads:
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`“Compliant sacs 200 may be disposed about the exterior of anchor 30 to
`provide a more efficient seal along irregular interface I.”
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`90. The omission of the sacs being compliant contravenes the provision of Art. 76 EPC.
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`(7)
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`91. Claim 7 specifies that the at least one sac (200) is provided as a continuous cylinder.
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`92. The only disclosure found in the original PCT application related to continuous
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`cylinders is found on page 33, first paragraph, which refers to Fig. 15B and specifies
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`that “the sacs are provided as continuous cylinders at various heights”. The sacs at
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`various heights are marked by arrows added to Fig. 15B:
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`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 22 of 50
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`::>"
`$5200
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`FIG: I58
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`93. Thus, an embodiment as covered by claim 7 with only a single sac provided as
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`continuous cylinder is nowhere disclosed. Furthermore, it was omitted from granted
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`claim 7 that said continuous cylinders are provided at various heights, r