throbber
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-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
`
`

`

`Bird Bird
`
`23 June 2016
`
`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
`
`

`

`Bird Bird
`
`23 June 2016
`
`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
`
`

`

`Bird Bird
`
`23 June 2016
`
`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
`
`

`

`Bird Bird
`
`23 June 2016
`
`
`
`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
`
`

`

`Bird Bird
`
`23 June 2016
`
`(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
`
`

`

`Bird Bird
`
`23 June 2016
`
`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
`
`

`

`Bird Bird
`
`23 June 2016
`
`(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
`
`

`

`Bird Bird
`
`23 June 2016
`
`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
`
`

`

`Bird Bird
`
`23 June 2016
`
`“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
`
`

`

`Bird Bird
`
`23 June 2016
`
`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
`
`

`

`Bird Bird
`
`23 June 2016
`
`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
`
`

`

`Bird Bird
`
`
`
`44. The locks shown in Fig. 15A comprise male interlocking elements 44, eyelets 45 and
`
`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
`
`

`

`Bird Bird
`
`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
`
`

`

`Bird Bird
`
`(5)
`
`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
`
`

`

`Bird Bird
`
`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
`
`

`

`Bird Bird
`
`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).
`
`63. Thus, anchor posts attached on the inside of the anchor are also an essential feature of
`
`the apparatus as claimed.
`
`(8)
`
`External cover
`
`64. Without an external cover, covering the anchor, even the attachment of sacs on the
`
`outside at various heights would not prevent regurgitation from occurring in between
`
`the sacs and through the anchor. Thus, a further essential feature also shown in the
`
`figures (e.g. figures 6, 7 and 15) has been omitted from claim 1, namely that the anchor
`
`must externally be covered by a sealing cover.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 17 of 50
`
`

`

`Bird Bird
`
`III.
`
`Features omitted in the context of the valve
`
`65. The valve must comprise commissures. Nothing else is shown in the figures (e.g. Figs.
`
`12 and 13).
`
`In addition, commissures are disclosed on page 22 of WO ’980 in the section defining
`
`the valve 20. In this context WO ’980 (page 22, 11. 31-33) provides:
`
`“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.”
`
`Further, the commissures are also required in View of a further essential feature,
`
`namely the anchor posts (see above).
`
`IV.
`
`Features omitted in the context of the sacs
`
`(1)
`
`Sacs distributed at various heights
`
`68. On page 32,
`
`11. 23-28 W0 ’980 mentions the risk of paravalvular leakage or
`
`regurgitation around the apparatus and explains with reference to figure 13 that this
`
`leakage occurs through the gaps between the leaflets L and the anchor 30:
`
`“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.”
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 18 of 50
`
`

`

`Bird Bird
`
`
`
`From figure 13 it is clearly visible that the gaps occur over the entire outer surface of
`
`the anchor 30.
`
`For this reason, all sacs disclosed in the specification cover a substantial portion on
`
`the exterior of the anchor in order to provide not only a local, spot-like seal but a
`
`“more efficient” seal along the entire irregular interface I (page 32, 11. 30—31 in
`
`conjunction with Figs. 5F, 6F, 13 (showing the irregular interface between leaflets L
`
`and anchor 30), 14 and 15). The sacs must therefore always be located at various
`
`heights on the exterior of the anchor.
`
`Sacs other than those located at various heights are not originally disclosed. Thus, the
`
`subject-matter of claim 1 constitutes a non-disclosed intermediate generalization.
`
`72. A failure to provide sacs at multiple heights on the outside of the device would
`
`inevitably also result in a lack of enablement (Art 83 EPC - this is further outlined
`
`below under the respective section), since the leakage would not be avoided in
`
`accordance to the opposed patent.
`
`(2)
`
`Compliant sacs
`
`73. The description only discloses compliant sacs (page 32, 11. 30-31). Non—compliant sacs
`
`are nowhere disclosed, but are currently included within the scope of claim 1. Also for
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 19 of 50
`
`

`

`Bird Bird
`
`this reason the subject-matter of granted claim 1 goes beyond the content of the
`
`originally filed specification.
`
`Inadmissible amendments to the dependent claims
`
`V.
`
`(1)
`
`None of the dependent claims comprises all essential features that have been omitted
`
`from claim 1 as granted (see above). Thus, each and every dependent claim also
`
`violates Art. 76 EPC for the same reasons set out above for claim 1.
`
`(2)
`
`Claim 2 specifies that the at least one sac (200) is “adapted to” be filled with blood.
`
`This claim is not originally disclosed for the following reasons:
`
`First, the original disclosure with respect to sacs that can be filled with blood is found
`
`on page 32, 11. 31-32 in the context of figure 14:
`
`
`
`Thus, this embodiment requires interconnected tubing connecting the sacs 200.
`
`Furthermore, nowhere is it mentioned that the sacs are “adapted” to be filled. Rather,
`
`the disclosure on page 32 makes it clear that the sacs may in preferred embodiments
`
`be filled with said appropriate material. In other words, in preferred embodiments the
`
`sacs comprise said material.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 20 of 50
`
`

`

`Bird Bird
`
`Any alternative embodiments where blood is used to fill the sacs are disclosed only in
`
`conjunction with very specific other features that are, however, missing from granted
`
`claim 2 (such as ‘fish-scale’ slots 202 that may be back-filled with blood passing
`
`through replacement valve or sacs that are open to lumen 31 of anchor 30 and can be
`
`filled by blood washing past the sacs as the blood moves through apparatus 10 l.
`
`Thus, claim 2 clearly represents a non-disclosed intermediate generalization.
`
`(3)
`
`Claim 3 is originally only disclosed in the context of further features in particular the
`
`sacs having multiple openings to lumen 31, i.e. to the inside of the anchor (cf. BB2,
`
`page. 33,11. 11-13).
`
`This embodiment disclosed in the description is also the only one that could possibly
`
`function (Art 83 EPC), since the blood can “wash past” the apparatus, i.e. move with
`
`velocity only on the lumen side / inside of the prosthesis. The exterior side of the
`
`apparatus is in direct contact with the blood vessel wall and on this exterior side the
`
`blood will not “wash” over the surface.
`
`(4)
`
`Claim 4 specifies that the at least one sac (200) comprises one or more slots (202)
`
`that can be used to back—fill the at least one sac with ambient blood passing through
`
`the replacement valve (20).
`
`It was omitted that the slots are shaped like fish scales as expressly mentioned in the
`
`description (page 33, ll. 9-10) and as shown in Fig. 16A, resulting in an impermissible
`
`and non-disclosed generalization of the scope.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 21 of 50
`
`

`

`Bird Bird
`
`(5)
`
`86. Claim 5 specifies that the at least one sac comprises one or more pores (204) that can
`
`be used to fill the at least one sac (200).
`
`87. However, the disclosure found in the description (page 33, 11. 10-11) only refers to “the
`
`sacs comprise pores 204 that may be used to fill the sacs”. Thus, no embodiment is
`
`disclosed wherein a single sac comprises pores nor where multiple sacs comprise a
`
`single pore. Thus, the subject—matter of granted claim 5 referring to “at least one sac”
`
`and “one or more pores” extends beyond the disclosed embodiment, in conflict with
`
`Art. 76 EPC.
`
`(6)
`
`88. Claim 6 defines that the at least one sac (200) is adapted to provide a seal along an
`
`irregular interface between the native valve leaflets and the anchor (30).
`
`89. However, the respective disclosure in BB2 on page 32,11. 30—31 reads:
`
`“Compliant sacs 200 may be disposed about the exterior of anchor 30 to
`provide a more efficient seal along irregular interface I.”
`
`90. The omission of the sacs being compliant contravenes the provision of Art. 76 EPC.
`
`(7)
`
`91. Claim 7 specifies that the at least one sac (200) is provided as a continuous cylinder.
`
`92. The only disclosure found in the original PCT application related to continuous
`
`cylinders is found on page 33, first paragraph, which refers to Fig. 15B and specifies
`
`that “the sacs are provided as continuous cylinders at various heights”. The sacs at
`
`various heights are marked by arrows added to Fig. 15B:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1152, Page 22 of 50
`
`

`

`Bird Bird
`
`::>"
`$5200
`
`FIG: I58
`
`93. Thus, an embodiment as covered by claim 7 with only a single sac provided as
`
`continuous cylinder is nowhere disclosed. Furthermore, it was omitted from granted
`
`claim 7 that said continuous cylinders are provided at various heights, r

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket