Peterreins Schley
`P otent- Lind Reentsanwalte GbR
`
`H erm ann-Sack-Straße 3
`80331 München
`Deutschland
`
`Tel: +49 (89) 8091338-00
`Fox: +49 (89) 8091338-88
`Moil: info@ ps-patent.com
`w w w .ps-paten t.com
`
`Dr. Frank Peterreins ‘
`Dr. Jan-M olte Schley^’ -
`Markus Coehn + ^
`Felix Glöckler +
`Dr. Matthias Trout
`Patrick W iedemann + ^
`
`' R G C h t'iQ n v y a lT
`' P o 'e n to r.w o it
`Europecin P o te rt A tiorney
`
`EPO - Munich
`82
`2 Aug. 2016
`
`P E T E R R E I N S S C H L E Y
`P A T E N T - U N D R E C H T S A N W Ä L T E
`
`P eterreinsSchley • Potsnl- ‘ irifl Rftchtsorw.ólte GbP ■ l-lerrucirin-Sock-StrnBe 3 • 8 0 3 3 L Múfr.hpn
`
`European Patent Office
`
`80298 Munich
`
`Munich, August 24, 2016
`Our ref: 31316-00440PI
`
`Opposition against EP 2 749 254 B l (14 161 991.6)
`Proprietor;
`Boston Scientific Scimed, Inc.
`Opponent 1 :
`Lang & Tomerius
`Opponent 2:
`Edwards Lifesciences Corp.
`Opponent 3:
`Medtronic CV Luxembourg S.à.r.l.
`
`In the name and on behalf of the Proprietor, it is requested
`
`1.
`2 .
`
`to reject the oppositions and to maintain the patent as granted;
`to summon for oral proceedings.
`
`A.
`
`Original Disclosure
`
`A.I
`
`Original Disclosure of Granted Claim 1
`
`The subject-matter of granted claim 1 is originally disclosed.
`
`1.
`The features of the preamble of granted claim 1 are - inter alia - disclosed in the PCT
`application WO 2005/0652980 (BB2) on page 1, lines 3/4, on page 17, lines 23 to 33, on page
`21, lines 25/26, and on page 22, lines 4 to 8 . Original claim 1 of the PCT application W O’980
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 1 of 42
`
`

`

`also provides a suitable disclosure for the preamble of granted claim 1, wherein it is clarified in
`the PCT application that using a braid is only an optional feature, see PCT application W O ’980,
`page 5, lines 4/5:
`
`‘‘The anchor includes an expandable anchor such as a braid. ”
`
`and page 22, lines 21-25:
`
`,.Anchor 30 preferably is fabricated by using self-expanding patterns (laser cut or
`chemically milled), braids, and materials, such as stainless steel, nickel-titanium
`( “Nitinol”) or cobalt chromium, but alternatively may be fabricated using balloon-
`expandable patterns where the anchor is desisned to plastically deform to its fin a l shape
`by means o f balloon expansion. ”).
`
`And finally, also original claims 89 and 340 provide a basis for the preamble of granted claim
`
`1.
`
`The characterizing feature of granted claim 1 is disclosed in context with Figures 32-
`2.
`34, see PCT application W O’980, page 34, lines 26-31:
`
`“Figures 32-34 show another way to seal the replacement valve against leakage. A
`fabric seal 380 extends from the distal end o f valve 20 and back proximally over anchor
`30 during delivery. When deployed, as shown in Figures 33 and 34, fabric seal 380
`bunches up to create fabric flaps and pockets that extend into spaces form ed by the
`native valve leaflets 30 382, particularly when the pockets are filled with blood in
`response to backßow blood pressure. This arrangement creates a seal around the
`replacement valve. ”
`
`and PCT application W O’980, page 8 6, lines 22-32:
`
`“Figures 32-34 illustrate the process o f forming a pleated seal around a replacement
`valve to prevent leakage. Figure 32 illustrates a fabric seal 380prior to deployment and
`foreshortening o f the anchor/valve apparatus. In Figure 32, the fabric seal 380 extends
`from the distal end o f valve 20 proximally over anchor 30 during delivery. During
`deployment, as illustrated in Figure 33, anchor 30 foreshortens and the fabric seal 380
`bunches up to create fabric flaps and pockets that extend into spaces form ed by the
`native valve leaflets 382. The bunched up fabric or pleats occur, in particular, when the
`pockets are filled with blood in response to backßow blood pressure. The pleating can
`create a seal around the replacement 30 valve. Figure 34 illustrates anchor 30,
`surrounded by fabric seal 380 in between native valve leaflets 382. In preferred
`embodiments, at least a portion o f a seal is captured between the leaflets and the wall
`o f the heart when the anchor is folly deployed. ’’
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 2 of 42
`
`

`

`■3 -
`
`The Opponents argue that several features have allegedly been described as being
`3.
`essential features, and that these features are missing in granted claim 1. However, none of
`these features are essential for achieving the sealing effect as explained in the application
`documents. Accordingly, none of these features is contained e.g. in claims 1, 89 and 340 of the
`PCT application W O’980. Indeed, many o f the objections raised are not truly objections under
`Article 123(2) EPC, but are in fact inadmissible objections relating to Article 84 EPC with
`respect to essential features allegedly missing.
`
`A.II Active Foreshortening is no Essential Feature
`
`The aspect of an “active foreshortening” is no essential feature as alleged by the Opponents.
`
`First o f all, an active foreshortening is not even mentioned in any o f independent claims
`1.
`1, 67, 101, 122, 142, 151, 182, 184, 255, 268, 340, 350, 367, 368, 387, 403 and 428 o f the PCT
`application W O’980. In view of these independent claims as originally disclosed, it is not
`understandable why the aspect of an active foreshortening should allegedly be essential.
`
`The aspect of an active foreshortening relates to a specific deliverv catheter - disclosed
`2.
`e.g. in context with Figures 3A to 3F - which axially compresses the anchor (without applying
`any radial forces) to achieve a radial expansion. However, the original application documents
`also clarify that other types of delivery catheters may be used to deploy heart valve implants o f
`the present invention, in particular bv balloon inflation:
`
`•
`
`PCT application W O’980, page 8, lines 15/16:
`
`“Expansion o f the anchor and replacement valve may be bv balloon-expansion, self-
`expansion, and combinations thereof ”
`
`•
`
`PCT application W O’980, page 13, lines 25-27:
`
`“The apparatus may also include a deployment tool coupled to the anchor within the
`catheter and an expandable balloon disposed within the deliverv catheter, the balloon
`beins adapted to expand the anchor. ”
`
`•
`
`PCT application W O’980, page 22, lines 21-25:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 3 of 42
`
`

`

`• 4 -
`
`,,Anchor 30 preferably is fabricated by using self-expanding patterns (laser cut or
`chemically milled), braids, and materials, such as stainless steel, nickel-titanium
`( “N itinol”) or cobalt chromium, but alternatively may be fabricated using balloon-
`expandable patterns where the anchor is designed to plastically deform to its final shape
`by means o f balloon expansion. ”
`
`As a result, the Opponents’ view that the heart valve implant of the present invention can only
`be deployed by an “active foreshortening” (applying axial compression forces), is incorrect.
`
`3.
`In addition, the general disclosure on a bunched-up fabric seal in the PCT application
`W O’980, on page 34, lines 26-31, does not mention any foreshortening:
`
`“Figures 32-34 show another way to seal the replacement yalye against leakage. A
`fabric seal 380 extends from the distal end o f yalye 20 and back proximally oyer anchor
`30 during deliyery. When deployed, as shown in Figures 33 and 34, fabric seal 380
`bunches up to create fabric flaps and pockets that extend into spaces form ed by the
`natiye yalye leaflets 30 382, particularly when the pockets are filled with blood in
`response to backflow blood pressure. This arrangement creates a seal around the
`replacement yalye. ”
`
`4.
`The embodiment of Figures 107A-C on which Opponent 2 is relying its objection, is
`only “another embodiment” as clarified in the PCT application W O ’980 on page 84, line 30.
`However, pointing to an additional alternative embodiment is no suitable argument for an
`essential feature, if the general disclosure of the invention does not require an active
`foreshortening.
`
`But even the embodiment of Figures 107A-C clarifies that achieving a bunched-up shape of the
`seal in the deployed configuration of the heart valve implant does not require any
`foreshortening. The PCT application W O ’980 only mentions on page 85, line 28, that
`“foreshortening can cause seal 60 to bunch up ... ”.
`
`5.
`Opponent 2 assumes that all problems mentioned in the PCT application must be solved
`by the apparatus/implant o f the opposed patent. This view is, however, based on a
`misunderstanding of the original disclosure.
`
`Contrary to Opponent 2 ’s allegation, the PCT application W O’980 does not require on page 4,
`lines 1-3, that all drawbacks mentioned in context with the prior art, must be solved according
`to the present invention (see Opponent 2’s opposition brief, paragraph 31). The words “methods
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 4 of 42
`
`

`

`• 5 -
`
`and apparatus” are mentioned in plural in this text passage. Therefore, the correct understanding
`of this passage is that various different solutions are provided in order to solve certain problems
`of prior art implants. The number and variety o f independent claims as originally filed already
`show that the PCT application discloses various different solutions addressing different
`drawbacks. However, forcing the Proprietor to include all advantageous aspects in an
`independent claim would unduly limit the right to get sufficient protection for an invention.
`
`And finally. Opponent 2 refers to page 27, lines 3-5 of the PCT application W O’980.
`6 .
`However, this passage relates to a different embodiment, namely the embodiment shown in
`Figures 5A to 5F, which does not even have a bunched-up fabric seal, see in particular Figure
`5E. Therefore, also this attempt of Opponent 2 to argue that an active foreshortening is an
`essential feature, must fail.
`
`A.III Non-Hydraullc/Non-Pneumatic Anchor Actuators are no Essential Features
`
`The non-hydraulic or non-pneumatic anchor actuators are no essential features.
`
`First of all, the non-hydraulic or non-pneumatic anchor actuators described in context
`1.
`with some embodiments of the PCT application are features of the delivery/deployment system,
`1.e. o f the catheter, but no features of the heart valve implant. Accordingly, the passage in the
`PCT application W O ’980 on page 21, lines 28-33, only refers to the delivery/deployment
`system, but not to the heart valve implant. Therefore, it is not logical that the non-hydraulic or
`non-pneumatic anchor actuators should allegedly be essential features of the heart valve
`implant.
`
`In addition, the original application documents also clarify that other types of delivery
`2.
`catheters may be used to deploy the heart valve implant o f the present invention, in particular
`bv balloon inflation:
`
`•
`
`PCT application W O ’980, page 8, lines 15/16;
`
`"Expansion o f the anchor and replacement valve may be by balloon-expansion. self­
`expansion, and combinations thereof. ”
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 5 of 42
`
`

`

`•
`
`PCT application W O’980, page 13, lines 25-27:
`
`‘‘The apparatus may also include a deployment tool coupled to the anchor within the
`catheter and an expandable balloon disposed within the deliverv catheter, the balloon
`beins adapted to expand the anchor. ”
`
`•
`
`PCT application W O’980, page 22, lines 21-25:
`
`,,Anchor 30 preferably is fabricated by using self-expanding patterns (laser cut or
`chemically milled), braids, and materials, such as stainless steel, nickel-titanium
`( “Nitinol”) or cobalt chromium, but alternatively may be fabricated using balloon-
`expandable patterns where the anchor is desisned to plastically deform to its final shape
`bv means o f balloon expansion. ”
`
`•
`
`PCT application W O’980, claim 96:
`
`“96. The apparatus o f claim 89 wherein the anchor and the replacement valve are
`adaptedfor expansion from the delivery to the deployed configurations via a mechanism
`chosen from
`the group consisting o f balloon-expansion. self-expansion, and
`combinations thereof”
`
`The embodiment of Figures 32 to 34 does not mention or show any non-hydraulic or
`3.
`non-pneumatic anchor actuators. And as mentioned above, the embodiment o f Figures 107A-
`C is only “another embodiment” (see PCT application W O’980 on page 84, line 30) which
`shows - e contrario - that non-hydraulic or non-pneumatic anchor actuators are no essential
`features of the heart valve implant according to the general teaching of the original application
`documents.
`
`A.IV Lockable Anchor and Locks are no Essential Features
`
`The lockable anchor and locks are no essential features either.
`
`As discussed in sections A.II and A.III above, neither an active foreshortening nor any
`1.
`non-hydraulic or non-pneumatic anchor actuators are essential features, because the anchor may
`- according to the original disclosure - also be balloon-expandable (which may result in some
`foreshortening of the anchor).
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 6 of 42
`
`

`

`■ 7 -
`
`2.
`The passage in the PCT application W O’980 on page 11, lines 16-18, cited by Opponent
`2 again refers to “another aspect o f the invention ” (see page 11, line 12), whereas the locking
`mechanism is explained as being an optional feature:
`
`“The apparatus may include a
`imposed
`locking mechanism fo r maintaining
`foreshortening, and it may be configured fo r retrieval prior to actuation o f the locking
`mechanism. ”
`
`The optional nature of the locking mechanism is also clarified in the summary section in the
`PCT application W O ’980 on page 4, line 31, to page 5, line 1:
`
`“In some embodiments the deplovins step mav include the stev o f exvandins a balloon
`within the anchor, and in some embodiments the deploying step mav include the step
`lockins the anchor in an expanded configuration. “
`
`3.
`The embodiment of Figures 32 to 34 does not mention or show any locking mechanism.
`And as already mentioned above, the embodiment of Figures 107A-C is only another
`embodiment (see PCT application W O’980 on page 84, line 30) which shows - e contrario -
`that the locking mechanism is no essential features of the heart valve implant according to the
`general teaching of the original application documents. Accordingly, the locking mechanism is
`not mentioned in independent claims 1, 89, and 340 as originally filed.
`
`4.
`In this respect. Opponent 2 again refers to page 27, lines 3-5 of the PCT application
`W O’980. However, this passage relates to another different embodiment, namely the
`embodiment shown in Figures 5A to 5F, which does not even have a bunched-up fabric seal,
`see in particular Figure 5E.
`
`A.V
`
`Self-Expandable Anchor is no Essential Feature
`
`The argument that a self-expandable anchor is allegedly an essential feature, is not convincing
`either. Balloon-expandable anchors are disclosed in the PCT application W O’980. Using a self-
`expandable anchor is only an optional feature. This is explicitly clarified in the PCT application
`W O’980 on page 22, lines 21-25:
`
`,,Anchor 30 preferablv is fabricated by using self-expandins patterns (laser cut or
`chemically milled), braids, and materials, such as stainless steel, nickel-titanium
`( “N itinol”) or cobalt chromium, but altemativelv may be fabricated using balloon-
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 7 of 42
`
`

`

`expandable vatterns where the anchor is desisned to plastically deform to its final shape
`bv means o f balloon expansion. ”
`
`A.VI Repositionable/Retrievable Anchor is no Essential Feature
`
`The aspect of repositioning and retrieving the heart valve implant is no essential feature. This
`is only an optional advantageous aspect as e.g. clarified in the PCT application on page 8 , lines
`30-32 ( “The apparatus mav be retrieved, repositioned and redeployed, and the apparatus may
`be locked in its expanded configuration. ”), on page 1 1, line 18 ( “... and it mav be configured
`fo r retrieval ... ”), and on page 13, line 18 ( "... optionallv retrieving ... ”).
`
`The aspect of repositioning and retrieving the heart valve implant is a separate independent
`invention which is defined in original claims 182 and 255 of the PCT application W O’980. But
`this aspect is not contained in any of the other independent claims as originally filed.
`
`A.VII Anchor Posts on the Inside are no Essential Features
`
`Using anchor posts on the inside for coupling the replacement valve to the anchor is no essential
`feature of the present invention.
`
`The disclosure passages in the PCT application W O’980 on page 22, lines 4 to 9, on page 34,
`lines 26 to 31, and on page 8 6, lines 22 to 32 do not even mention posts for connecting the
`replacement valve to the anchor. Original independent claims 1, 67, 89, 101, 122, 142, 151,
`169, 182, 184,255, 268, 340, 368, 387 and 403 do not mention posts on the inside o f the anchor
`either. And finally, the summary section of the PCT application W O’980 on pages 4 to 15 do
`not mention any posts. These facts alone prove that providing the anchor with posts on the
`inside is merely an optional feature.
`
`The sentence in the PCT application W O’980 on page 22, lines 31 to 33, cited by Opponent 2,
`clarifies itself that coupling the replacement valve to posts is only a preferred feature. Posts are
`only an optional feature, if a lockable self-expandable anchor is used. However, as discussed
`above, a lockable self-expandable anchor is not essential for carrying out the claimed invention,
`because a balloon-expandable anchor may altematively be used.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 8 of 42
`
`

`

`9 -
`
`The passage in the PCT application W O’980 on page 27, lines 1 to 6 , also cited by Opponent
`2, relates to an embodiment which does not even have a bunched-up fabric seal. This again
`proves that posts are not essential in context with a bunched-up fabric seal.
`
`Opponent 2 further argues that the embodiment of Figures 107A-C of the PCT application
`W O’980 can also be locked, and that a post is shown in Figure 107B. But Opponent 2 ignores
`that the embodiment of Figures 32 to 34 of the PCT application W O’980 does not show any
`posts. Accordingly, posts are neither mentioned on page 34, lines 26 to 31, nor on page 8 6 , lines
`22 to 32. Therefore, the embodiment of Figures 107A-C of the PCT application W O ’980 has
`only additional advantageous features compared to the embodiment of Figures 32 to 34. But
`those additional features are certainly not essential for the claimed invention.
`
`A.VIII Leaflet Engagement Elements are no Essential Features
`
`Using leaflet engagement elements is no essential feature of the claimed invention as alleged
`by Opponents 2 and 3. Leaflet engagement elements are only another inventive aspect defined
`in original claims 101 and 122. However, this aspect is not mentioned in any other independent
`claim the PCT application W O’980. Accordingly, the disclosure passages in the PCT
`application W O’980 on page 22, lines 4 to 9, on page 34, lines 26 to 31, and on page 8 6 , lines
`22 to 32 do not even mention leaflet engagement elements, and no leaflet engagement elements
`are shown in Figures 32 to 34 either.
`
`A.IX Braided Anchor is no Essential Feature
`
`Using a braided anchor is no essential feature of the claimed invention. The PCT application
`W O’980 clarifies on page 22, line 5, that a braid is only an optional feature ( “... expandable
`anchor such as a braid. ”). The passages on page 22, lines 21 to 25, and on page 39, lines 18 to
`27, explicitly mention that plastically deforming balloon-expandable anchors may be used
`instead of braided anchors. And the disclosure passages in the PCT application W O’980 on
`page 34, lines 26 to 31, and on page 8 6 , lines 22 to 32 do not even mention a braided anchor.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 9 of 42
`
`

`

`- 1 0
`
`The aspects of active foreshortening and using a self-expandable braided anchor which can be
`locked in its expanded state are only other inventive aspects which are not essential in context
`with a bunched-up fabric seal.
`
`A.X Commissures are no Essential Features
`
`Commissures are no essential features in context with a bunched-up fabric seal. None o f the
`independent claims as originally filed contains the feature of commissures. The summary
`section on pages 4 to 15 of the PCT applieation W O’980 does not mention commissures either.
`The sentence in the PCT application W O’980 on page 22, lines 31 to 33, cited by Opponent 2,
`also clarifies that commissures may only be “preferably” used.
`
`A.XI Horizontal Pleats, Flaps and/or Pockets are no Essential Features
`
`The Opponents argue that various aspects relating to the shape and to the arrangement o f the
`bunched-up fabric seal are essential.
`
`In this respect, it should be noted first that claim 1 already contains features on the
`1.
`arrangement of the fabric seal, namely that it is “extending from the distal end o f the valve (20)
`proximally over the anchor in the delivery configuration, wherein the seal is bunched up in the
`deployed configuration”. This wording, which is in line with the disclosure in the PCT
`application W O ’980 on page 34, lines 26 to 28, already clarifies that the fabric seal is at least
`partially arranged around the outside of the anchor. Therefore, Opponent 2 ’s submission in
`paragraph 86 of its opposition brief regarding the arrangement of the fabric seal is not
`understandable.
`
`The word “pleats” is not mentioned in the PCT application W O’980 on page 34, lines
`2.
`26 to 31, either, and cannot be regarded as being an essential feature. The passage on page 85,
`lines 28/29, refers to a different advantageous embodiment and clarifies that “pleats” can
`optionally be formed.
`
`Besides that. Opponent 2 ’s argument is in contradiction to its position in context with novelty
`of the granted claims, because Opponent 2 argues in paragraphs 123, 152 and 179 of its
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 10 of 42
`
`

`

`11
`
`-
`
`opposition brief that “bunched up” is used synonymously to “flaps” and “pleats” in the patent
`specification;
`
`123. The terms “flaps”, “pleats” and “bunched up” seal are used in the specification
`synonymously (see BBa, page 8 5,11. 28-29, page 86,11. 22-23, page 8 6 ,11. 27-28 and
`page 34, 11. 28-29).
`
`Opponents 1 and 3 believe that the wording “to create fabric flaps and pockets that
`3.
`extent into spaces form ed by the native valve leaflets” is missing in granted claim 1. However,
`this phrase only describes the effect which can be achieved by the bunched-up fabric seal during
`use. Granted claim 1 is a product claim, and the features of a product claim must be recognizable
`independent from its use. The relevant structural features on the bunched-up fabric seal are
`already contained in granted claim 1. Therefore, there is no need to include additional
`clarifications on the inventive effect during use.
`
`thus confuse the structural features on the one hand, and the
`Opponents 1 and 3
`technical/medical effect on the other hand. The effect is that - during use - flaps and pockets
`can extend into spaces formed by the native valve leaflets. This is achieved by the bunched-up
`fabric seal.
`
`Opponent 1 tries to base its argument on the words “to” and “that” (see opposition brief, page
`5, paragraph 5), and even admits that the phrase starting with “to” describes the “specific
`functional purpose” (i.e. the technical/medical effect). However, Opponent 1 did not recognize
`that the entire phrase ( “to create fabric flaps and pockets that extent into spaces form ed by the
`native valve leaflets”) starts with the word “to”, i.e. the entire phrase relates to the
`technical/medical effeet achieved by the bunched-up fabric seal.
`
`Referring to Figure 33, Opponent 2 further believes that the fabric seal must comprise
`4.
`circumferential and horizontal pleats. However, the wording “circumferential and horizontal”
`is neither mentioned in the PCT application W O’980 on page 34, lines 26 to 31, nor on page
`8 6, lines 22 to 32. Figure 33 shows a schematic drawing to illustrate an example o f a bunched-
`up fabric seal. Therefore, that the Proprietor cannot be forced to introduce this wording in
`granted claim 1.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 11 of 42
`
`

`

`1 2 -
`
`A.XII Foreshortening is no Essential Feature
`
`The Opponents further believe that the fabric seal and the anchor must foreshorten during
`deployment.
`
`However, a foreshortening of the anchor and/or fabric seal is not mentioned in the relevant text
`passage on PCT application W O’980 on page 34, lines 26 to 31, at all; nothing has been
`“omitted” in this respect. Therefore, it is clear that a foreshortening has not been described as
`being an essential feature.
`
`Figure 33 shows a schematic drawing to illustrate one possible example o f a bunched-up fabric
`seal. Therefore, the Proprietor cannot be forced to introduce such wording in granted claim 1.
`
`It is only essential - as mentioned in granted claim 1 - that the fabric seal is bunched-up in the
`deployed state (which can be seen when the heart valve implant is expanded to its intended
`deployed diameter in air, and which results in that the fabric seal can extend into spaces formed
`by the native valve leaflets when the heart valve implant is implanted into a patient).
`
`The PCT application W O’980 even clarifies on page 85, lines 28/29, that a foreshortening is
`only an optional mechanism to cause bunching up:
`
`“Foreshortenins can cause seal 60 to bunch up and create pleats. ”
`
`As a result, a foreshortening of the fabric seal and/or the anchor is not essential.
`
`A.XIII Shape of the Seal in the Delivery Configuration is no Essential Feature
`
`According to granted claim 1, the fabric seal must have a bunched-up shape in the deployed
`configuration. Contrary to Opponent 2’s submission, it is not essential whether and how much
`the fabric seal is bunched-up in the delivery configuration o f the heart valve implant.
`
`The text passage in the PCT application W O’980 on page 34, lines 26 to 31, is silent on the
`shape of the fabric seal in the delivery configuration o f the heart valve implant. Figure 32 is
`only a schematic drawing illustrating one embodiment of the claimed invention. And the text
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 12 of 42
`
`

`

`13
`
`passage in the PCT application W O’980 on page 85, lines 28/29, mentions that foreshortening
`“can cause seal 60 to bunch up This means that a foreshortening o f the anchor - if present -
`may only be optionally provided for causing the fabric seal to bunch up.
`
`In view of the purpose of the fabric seal to reduce or avoid a reverse blood flow (between the
`implant and the annulus), only the bunched-up shape of the fabric seal in the deployed
`configuration is o f importance, whereas the shape o f the fabric seal in the delivery configuration
`o f the heart valve implant is not relevant for the sealing function.
`
`A.XIV Attachment of the Seal at the Proximal End is no Essential Feature
`
`The relevant text passages describing the fabric seal are silent on whether or not the fabric seal
`is attached to the upper end of the anchor. Opponent 2 ’s argument that this feature missing in
`granted claim 1 allegedly results in an inadmissible intermediate generalization, is not
`understandable. Figure 34 is only a schematic drawing showing the anchor 30 and the native
`leaflets 382. It is clear to the skilled person that such a schematic drawing is not intended to
`show any details on the fixation o f the fabric skirt.
`
`A.XV Wording “proximally over the anchor” is originally disclosed
`
`Opponent 2 believes that the word “back” should be included in granted claim 1. However,
`granted claim 1 already contains the feature that the fabric seal is “extendins from the distal
`end o f the valve (20) proximallv over the anchor
`The wording “back proximally over
`anchor 3 0 ” has the same meaning as the wording “proximally over the anchor", namely that
`the part of the fabric seal which is arranged outside o f the anchor should extend in proximal
`direction.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 13 of 42
`
`

`

`14
`
`30
`
`■20
`
`FIG. 33
`
`380
`
`380
`
`■20
`
`FIG. 32
`
`As can be seen in Figures 32 and 33 of the PCT application, the fabric seal may have an inner
`end which is arranged within the anchor so that the replacement valve, which is fully arranged
`within the anchor, can be connected to the fabric seal. The inner part of the fabric seal may thus
`first extend in distal direction, and then change its direction at the distal end o f the anchor, so
`that the outer part of the fabric seal can then extend in proximal direction.
`
`A.XVI The Features “bunched-up” and “deployed configuration” have been disclosed in
`combination
`
`Opponent 1 argues that the features “bunched-up” and “deployed configuration” have allegedly
`not been disclosed in combination. This is, however, incorrect.
`
`As already mentioned in Section A.I.2 above, these features are disclosed in combination e.g.
`in the PCT application W O’980, on page 34, lines 28 to 31 ;
`
`“When deployed, as shown in Figures 33 and 34, fabric seal 380 bunches up to create
`fabric flaps and pockets that extend into spaces form ed by the native valve leaflets 30
`382, particularly when the pockets are filled with blood in response to baclflow blood
`pressure. This arrangement creates a seal around the replacement valve. ”
`
`This passage refers to the shape of the fabric seal in the deploved state of the heart valve
`implant, and not to the deployment procedure. As discussed in Section A.XII above, a
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 14 of 42
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`

`- 15 -
`
`foreshortening o f the anchor is only optional. In particular, the text passage in the PCT
`application W O’980 on page 85, lines 28/29, mentions that foreshortening “can cause seal 60
`to bunch up The same applies to the question whether or not the fabric seal must additionally
`bunch up as a result of the deployment procedure.
`
`A.XVII Amendments to the Description are admissible
`
`Mentioning the wording of granted claim 1 in the adapted summary section o f the opposed
`patent is no violation of Art. 123 (2) / 76 EPC, because granted claim 1 is originally disclosed.
`
`Opponent 2 objects that there is allegedly no basis in the original application documents for the
`last sentence o f paragraph [0018] of the patent specification { “The seal can be adapted to
`prevent blood flow around the replacement valve and the anchor when the anchor and the
`replacement valve are fully deployed. ”). However, Opponent 2 obviously missed to note
`original claim 119 which provides literal support for this feature.
`
`A.XVIII Dependent Claims 12 and 13 are originally disclosed
`
`W ith regard to granted claim 12, Opponent 2 alleges that there is no original disclosure in the
`PCT application for a balloon-expandable anchor. Opponent 2 obviously did not note the
`disclosure in the PCT application W O’980 on page 8 , lines 15 to 17, on page 22, lines 23/24,
`on page 30, lines 6 to 10, and in original claim 96.
`
`Opponents 2 and 3 also object the original disclosure of granted claim 13. But the features of
`granted claim 13 are disclosed in the PCT application W O’980 on page 8 6 , lines 31/32.
`Opponent 2 ’s objection mentioned in paragraph 107 of its opposition brief seems to be rather
`an objection under Art. 83 EPC, but not under Art. 123 (2) / 76 EPC.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1131, Page 15 of 42
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`- 1 6
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`B.
`
`Sufficiency of Disclosure
`
`Opponent 2 did not submit any suitable argument why the skilled person should not be able to
`carry out the invention in knowledge o f the teaching of the opposed patent. As explained in
`context with Figs. 22 to 24 as well as in context with Figs. 29A to 29C of the opposed patent,
`the fabric seal is — according to the present invention — bunched-up in the deployed state o f the
`heart valve implant to provide an improved sealing effect. A bunched-up fabric seal is suitable
`to better adapt to the irregular surface o f the surrounding tissue at the implantation site.
`
`The additional objection of Opponent 2 that allegedly some essential features are missing in
`granted claim 1, is no suitable objection under Art. 83 EPC. The Opponents raised the same
`objections already under Art. 123 (2) / 76 EPC. However, as discussed in Section A above in
`detail, the arguments of the Opponents on allegedly missing features are not justified.
`
`C.
`
`Novelty of Granted Claim 1
`
`C.I
`
`Subject-matter o f the present invention
`
`Accord