LANG & TOMERIUS
`Patentanwaltspartnerschaft mbB
`
`Rosa—Bavarese-Str. 5
`D-80639 Miinchen
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`LANG & TOMERIUS - Rosa-Bavarese—Str. 5 - D-80639 Miinchen
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`
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`EPo
`
`. Mu ,
`50 Inch
`02- 390- 2015
`
`FRIEDRICH LANG
`Diplom—lngenieur
`'
`(bis September 2013)
`
`DR. ISABEL TOMERIUS
`Diplom<Chemikeri n
`Tomerius@ patented.de
`
`DR. PHILIPP HEIDLER
`Pharrnazeut ‘ Approb. Apodweker
`Heidler@patented.de
`Patentanwalte
`
`European Patent Attorneys
`European Trademark Attorneys
`European Design Attorneys
`
`ANNA FRIESER
`
`Angestellte Rechtsanwaltin
`Frieser@patented.de
`
`MONIKA BANDOUCH
`
`Angestellte Rechtsanwa'ltin
`Fachanwaltin flir Gewerb-
`lichen Rechtsschutz
`Bandouch@patented.de
`
`Partnerschaftsregister
`AC Mijnchen - PR 1363
`
`Ihr Zeichen
`
`Your Ref.
`
`Unser Zeichen HP 785 EP
`
`Datum 02.09.2015
`
`Our Ref.
`
`TO/pe
`
`Date
`
`Patent No.
`Owner:
`
`2749254 (Patent Application No. 141619916)
`Boston Scientific Scimed, Inc.
`
`Opponent:
`
`Lang & Tomerius Patentanwaltspartnerschaft mbB
`
`NOTICE OF OPPOSITION
`
`I.
`
`AN OPPOSITION IS FILED AGAINST
`
`Patent No.:
`
`Application No.:
`Date of grant:
`Title:
`
`ll.
`
`PATENT OWNER
`
`2749254
`
`14161991 .6
`
`22 December 2004
`
`Repositionable heart valve
`
`Boston Scientific Scimed, Inc.
`One Scimed Place
`
`Maple Grove, MN 55311-1566
`United States of America
`
`‘Zur Kaeee
`
`Was (a
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 1 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 1 of 16
`
`

`

`III. OPPONENT
`
`IV.
`
`REQUESTS
`
`Lang & Tomerius Patentanwaltspartnerschaft mbB
`Rosa-Bavarese-Str. 5
`
`80639 MUnchen
`
`Germany
`
`1.
`
`It is requested to revoke the patent in its entirety, based on the grounds that
`
`-
`
`-
`
`-
`
`its subject-matter extends beyond the content of the application as filed (Art. 100(c) EPC and Art.
`
`123(2)/Art 76(1) EPC);
`
`its subject-matter is not novel.(Art. 100(a) EPC and Art. 54 EPC);
`
`its subject-matter does not involve an inventive step (Art. 100(a) EPC and Art. 56 EPC).
`
`2. Oral proceedings are requested in the event that the patent cannot be revoked on the basis
`
`of the written proceedings.
`
`V.
`
`PRIOR ART
`
`The opposition is based on the following prior art:
`
`D1
`
`D2
`
`D3
`
`D4
`
`D5
`
`D6
`
`D7
`
`WO 98/29057 A1 (D1); published on 09 July 1998,
`
`FR 2 826 863 A1 (D2); published on 10January 2003,
`
`US 5,957,949 A (D3); published on 28 September 1999,
`
`US 4,084,268 A (D4); published on 18 April 1978,
`
`WO 01/76510 A2 (D5); published on 18 October 2001,
`
`US 2002/0032481 A1 (D6); published on 14 March, 2002,
`
`Extract from online Macmillan dictionary for the term "bunch up”
`
`("www.macmilland ictionary.com/dictionary/british/bunch_2 ”).
`
`VI.
`
`REASONS
`
`1 . The opposed patent EP 2 749 254 B1
`
`1.1
`
`Subject matter
`
`The opposed patent (hereinafter the "patent in suit”) relates to an apparatus for endovas-
`
`cularly replacing a heart valve comprising a seal (claim 1).
`
`The patent in suit shows a heart valve which comprises a seal. The seal comprises a fabric
`
`seal which extends from the distal end of valve 20 proximally over anchor during delivery
`
`([0121]). During deployment, as illustrated in Figure 23, anchor 30 foreshortens and the
`
`fabric seal 380 bunches up to create fabric flaps and pockets that extend into spaces
`
`formed by the native valve leaflets 382 ([0121]). The bunched up fabric or pleats may oc—
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 2 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 2 of 16
`
`

`

`cur, when the pockets are filled with blood in response to backflow blood pressure
`
`([0121]). Figure 24 illustrates anchor 30, surrounded by fabric seal 380 in between native
`
`valve leaflets 382 ([0121]).
`
`In preferred embodiments, at least a portion of a seal is cap-
`
`tured between the leaflets and the wall of the heart when the anchor is fully deployed
`
`([0121], [0326]).
`
`380
`
`1.2 Claim 1
`
`The patent in suit comprises one independent claim with the following features of the
`
`preamble:
`
`(P1) Apparatus for endovascularly replacing a patient's heart valve, the apparatus com-
`
`prising:
`
`(P2)
`
`an expandable anchor (30),
`
`(P3)
`
`supporting a replacement valve,
`
`(P4)
`
`the anchor (20) having a delivery configuration and a deployed configuration, the
`
`object is allegedly solved with the following features of the characterizing portion:
`(C1) a fabric seal,
`I
`
`(C2) extending from the distal end of the valve (20) proximally over the anchor in the de-
`
`livery configuration,
`
`(C3) wherein the seal is bunched up,
`
`(C4)
`
`in the deployed configuration.
`
`2. Added subject matter (Art. 100(c) [PC and Art. 76(1) EPC or Art. 123(2) EPC)
`
`The application to the patent in suit was filed as a divisional application of EP 1 702 247 (parent
`
`application), originally published as international application WO 2005/062980 A2.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 3 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 3 of 16
`
`

`

`Hereinafter, references to the text of the parent application as filed are made with respect to
`
`WO 2005/062980 A2 as published. «
`
`2.1
`
`lnadmissible extraction of an isolated feature as compared to WO 2005/062980 A2
`
`Features C1-C3 of claim 1 as granted are not based on a claim as filed in the parent appli-
`
`cation but solely on the description on page 24, lines 1—7, and page 60, lines 9-20, and
`
`figures 32-34 of the original application (according to the Examiner — see annex to the
`
`Communication ofJune 18, 2014).
`
`Claim 1 as granted contains inadmissiny extracted isolated features of the apparatus for
`
`endovascularly
`
`replacing
`
`a
`
`heart
`
`valve
`
`described
`
`in
`
`the
`
`original
`
`application
`
`WO 2005/062980 A2 (published July 14, 2005). Thus, claim 1 contains intermediate
`
`generalizations concerning the features fabric flaps and pockets that extend into spaces
`
`formed by the native leaflets and foreshortening:
`
`a)
`
`Fabric flaps and pockets that extend into spaces formed by the native leaflets
`
`The parent application reads on page 34, lines 26-31:
`
`"Figures 32-34 show another way to seal the replacement valve against leakage. A fab-
`
`ric seal 380 extends from the distal end of valve 20 and back proximal/y 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 formed by the
`
`native valve leaflets 382, particularly when the pockets are filled with blood in re-
`
`sponse to backflow blood pressure. This arrangement creates a seal around the re-
`
`placement valve".
`
`The features missing in claim 1 of the patent in suit (underlined above) are:
`
`creating fabric flaps and pockets
`
`-
`
`that extend into spaces formed by the native valve leaflets.
`
`These features are not to be omitted since they are presented as essential features in
`
`combination with the features C3 and C4 incorporated into claim 1 whenever originally
`
`mentioned:
`
`”anchor 30 foreshortens and the fabric seal 380 bunches up to create fabric flaps and
`
`pockets that extend into spaces formed by the native valve leaflets 382” — see page 86,
`
`lines 26-27 of the parent application.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 4 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 4 of 16
`
`

`

`Omitting these individual features is an unallowable extension of the subject matter as ini-
`
`tially filed in the parent application. The desired sealing effect is o_nly possible due to the
`
`fabric flaps and pockets which extend into spaces formed by the native valve leaflets. On-
`
`ly thereby a sealing effect is reached, which is acknowledged by the proprietor. A mere
`
`bunching up is obviously insufficient.
`
`Referring to D7, the term l’bunch” or "bunch up” also has a very general meaning which
`
`does not inherently result
`
`in the creation of flaps and pockets extending into spaces
`
`formed by native valve leaflets. The term "bunch up" generally means to form into a tight
`
`round shape, and the term “bunch” for cloth means to come together in small folds. Just
`
`referring to "bunching up” therefore covers (i) even a small amount of folding or bending
`
`not necessarily sufficient to form flaps and pockets that will extend into spaces formed by
`
`native valve leaflets; and (ii) forming a rounded shape without necessarily forming flaps
`
`and pockets; and (iii) bunching of the fabric at a different position not even in contact
`
`with the native valve leaflets (e.g. internally of the anchor).
`
`Therefore, the granted claim has been significantly broadened compared to the disclosure
`
`of the original WO 2005/062980 A1 .
`
`The unallowable generalization or omission becomes even more apparent in view of the
`
`fact that both omitted features are clearly related to each other:
`
`In the present case, a skilled reader cannot be assumed to have any doubts as to whether
`
`missing features are in a structural or functional relationship with claimed features C3 and
`
`C4 (T 1067/97). This follows from the conjunctions "to" and "that" and from the fact that
`
`there is no disclosure indicating that the above features may be selected separately. The
`
`conjunction "to" emphasizes the specific functional purpose of the bunching up (i.e. cre-
`
`ating fabric flaps and pockets) and the conjunction "that" describes structural features (i.e.
`
`extending into spaces formed by the native valve leaflets) of the bunching up.
`
`Moreover the patent language clearly distinguishing between single facultative features
`
`(see e.g. the end of the same sentence, p. 34, I. 30-31 ; "particularly when the pockets are
`
`filled with blood”) appears to be consistent in this respect.
`
`Therefore, the isolation of features C3/C4 without the structurally and/or functionally re-
`
`lated features "creating fabric flaps and pockets” and "that extend into spaces formed by
`
`the native valve leaflets” leads to an inadmissible intermediate generalization.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 5 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 5 of 16
`
`

`

`
`
`Hence, the generalized claim 1 lacks basis in the parent application and claim 1 thus con-
`
`travenes Art. 76(1) EPC.
`
`b)
`
`Foreshortening
`
`The parent application reads on page 86, lines 26-27:
`
`"anchor 30 foreshortens and the fabric seal 380 bunches up to create fabric flaps and
`
`pockets that extend into spaces formed by the native valve leaflets 382”.
`
`The feature missing in claim 1 of the patent in suit (underlined above) is that the anchor
`
`foreshortens in order to bunch the fabric seal up.
`
`This feature is not to be omitted since it is presented as an essential feature in combina-
`
`tion with the features C3 and C4 incorporated into claim 1 whenever originally men-
`tioned:
`
`Figures 32-34 show another way to seal the replacement valve against leakage. A fabric
`
`seal 380 extends from the distal end of valve 20 and back proximally over anchor 30 dur-
`
`ing 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 formed by the native valve” - see
`
`page 34, lines 26-31 of the parent application“;
`
`The figures 32-34illustrate a deployment process (fig. 32) of the device. During delivery
`
`(fig. 32) the seal is not bunched up, whereas during deployment (fig. 33 and 34) the an-
`
`chor foreshortens and the seal bunches up. Thus, they are clearly functionally related.
`
`Omitting this feature is an unallowable extension of the subject matter as initially filed in
`
`In the parent application the desired bunching up is only shown
`the parent application.
`when the anchor is in the foreshortened state.
`
`A skilled reader cannot be assumed to have any doubts as to whether the missing feature
`
`is in a structural or functional relationship with claimed features C3 and C4 (T 1067/97).
`
`This follows from the use of the conjunction “and” and from the fact that there is no dis-
`
`closure indicating that the above features may be selected separately.
`
`Moreover the patent language clearly distinguishing between single facultative features
`
`(see e.g. the end of the same paragraph p. 86,
`
`I. 31-32; ” n preferred embodiments, at
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 6 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 6 of 16
`
`

`

`least a portion of a seal is captured between the leaflets and the wall of the heart when the
`
`anchor is fully deployed”) appears to be consistent in this respect.
`
`Hence, the generalized claim 1
`
`lacks basis in the parent application and claim 1 thus con-
`
`travenes Art. 76(1) EPC.
`
`c)
`
`Summary
`
`For the above reasons, claim 1 contains several inadmissible extractions of isolated fea-
`
`tures (T 25/03) and the subject matter of claim 1 extends beyond the subject matter of the
`
`earlier application as filed (Art. 76 (1) EPC).
`
`2.2 New combination of features (features C3 and C4)
`
`Features C3 and C4 also represent a new combination of features that extends beyond
`
`the original disclosure.
`
`Features C3 and C4 define merely that the seal is bunched up (C3) in the deployed con-
`
`figuration (C4). However, features C3 and C4 are silent about the state of the seal prior to
`
`being in the deployed configuration. For example, claim 1
`
`is not limited to whether the
`
`seal is “bunched” or “non-bunched" when in the delivery configuration, provided that the
`
`seal extends somehow “over” the anchor (C2). However, the term "over" just means
`
`“outside”, and does not require the seal to be flat and non-bunched in the delivery con-
`
`figuration. The word “over” has no relation to whether or not material is bunched.
`
`Thus there is nothing in the claim language that excludes the same bunching of material in
`
`the delivery configuration, or some other configuration. For example, claim 1 does not
`
`define bunching only in the deployed configuration. Nor does claim 1 define that bunch-
`ing takes place during deployment of the anchor.
`I
`
`In
`
`stark
`
`contrast,
`
`the
`
`corresponding
`
`text
`
`passages
`
`the
`
`original
`
`application
`
`(WO 2005/062980 A1) on which claim 1 is allegedly based, read:
`
`"When deployed, as shown in Figures 33 and 34, fabric seal 380 bunches up to cre—
`
`ate fabric flaps and pockets that extend into spaces formed by the native valve leaf-
`
`lets” - p. 34, I. 28-31.
`
`"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
`
`formed by the native valve leaflets 382” — p. 86, I. 25-27.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 7 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 7 of 16
`
`

`

`
`
`Therefore, in the original application, the bunching up takes place specifically "during de-
`
`ployment”, or said differently the seal bunches up as a direct result "when deployed”.
`
`This only includes heart valves configured to deploy with a deployment step involving
`
`bunching up of the seal. However, the combination of features C3 and C4 extends to any
`
`heart valve with a bunched up seal regardless of how and when the fabric seal is bunched
`
`up. For example, the new combination of features C3 and C4 extends to a valve in which
`
`a seal is bunched up during its fabrication process and left unaltered with respect to the
`
`bunching during any of the deployment steps in a later implantation. Such a valve would
`
`include a seal that "is bunched up in the deployed configuration” and consequently be
`
`covered by Claim 1
`
`(assuming features P1 -C2 are shown as well). Clearly this proposed
`
`valve is not disclosed in the parent application but within the scope of protection of
`claim 1.
`
`Therefore, the combination of features C3 and C4 is not directly and unambiguously de-
`
`rivable from WO 2005/062980 A1 (see C 1/06) and represents added subject matter
`
`within the meaning of Art. 76(1) EPC.
`
`3.
`
`Lack of novelty (Art 100(a) EPC and Art. 54 EPC) over WO 98/29057 A1 (D1)
`
`Document D1 was filed on December 31, 1997 and published on July 9, 1998, Le. prior to the
`
`alleged priority date of the patent in suit of December 23, 2003. D1 therefore constitutes prior
`
`art according to Art. 54(2) EPC.
`
`
`
`FlG-4b
`
`
`(P1) Apparatus for endovascularly replacing a patient's heart valve, the apparatus comprising:
`
`D1 discloses a valve prosthesis for implantation in body channels, more particularly but not only
`
`to, cardiac valve prosthesis (see p. 1, |. 4-6).
`
`Hence, D1 anticipates feature P1.
`
`(P2) An expandable anchor.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 8 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 8 of 16
`
`

`

`The valve prosthesis includes an expandable frame 10 (see p. 14, l. 13, p. 18, l. 10 and figs. 4a
`
`and 4b).
`
`Hence, D1 anticipates feature P2.
`
`(P3) Supporting a replacement valve.
`
`The valve prosthesis further comprises a valvular structure 14 which is constituted by a soft tissue
`
`(see p. 18, l. 16). The tissue is fastened to the frame (see p. 18, l. 18) and thus the frame 10 sup-
`
`ports the valvular structure 14.
`
`Hence, D1 anticipates limitation P3.
`
`(P4)
`
`the anchor (20) having a delivery configuration and a deployed configuration, characterized
`
`by
`
`The valve prosthesis, and thus the frame (10) as well, have a compressed and an expanded con-
`
`figuration (see p. 18, |. 1—4 and figs. 4a and 4b).
`
`Hence, P4 is shown in D1.
`
`(C1 /C4)
`
`A fabric seal.
`
`As can be seen in fig. 6d, the valve prosthesis contains an external cover 19". The external cover
`
`is made from the same tissue as the valvular structure (p. 22, I. 13-14), wherein this tissue may
`
`be made of Dacron (see p. 8, I. 14-15). Dacron is a commonly utilized fabric in cardiac surgery
`
`(see D4, col. 3, l. 47). The external cover 19" limits a flow around the frame'10 and thus acts as
`
`a paravalvular seal.
`
`Hence, feature C1 is shown in D1.
`
`(C2/C4)
`
`Extending from the distal end of the valve (20) proximally over the anchor in the de-
`
`livery configuration.
`
`As can be clearly observed from fig. 6d, the cover 19 extends from a distal end of the valvular
`
`structure, around the distal end of the frame 10 and proximally over the anchor like in figs. 22
`
`and 23 of the patent in suit. Hence, C2 is shown in D1. ‘
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 9 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 9 of 16
`
`

`

`1O
`
`(C3/C4)
`
`wherein the seal is bunched up in the deployed configuration.
`
`The external cover 19” is moulded, glued or soldered to bars 11 of frame 10 (see p. 22, l. 25-
`
`26). When the frame is in its expanded state the frame has a height of approximately between
`
`10 and 15 mm and in its fully compressed frame, a height of approximately 20 mm (see p. 14,
`
`I. 16-17).
`
`This foreshortening is also observable when comparing the relation of the longitudinal dimen-
`
`sions of base 15 and valvular structure 15 in figures 4a (compressed configuration) and 4b (ex-
`
`panded configuration). The rhombical orifices of the frame 10 are expanded in a circumferential
`
`direction and shortened in a longitudinal direction of the stent.
`
`Thus, like the anchor in the patent in suit, the frame 10 foreshortens during deployment. Since
`
`the frame 10 is foreshortened there is excessive material of the external cover in the longitudinal
`
`direction of the frame. As the external cover is attached to the bars, the excessive material is in—
`
`herently bunched up in the deployed configuration.
`
`The fact
`
`that bunching up occurs as a response to foreshortening was common general
`
`knowledge in the art at the alleged priority date as explained for example in D3 (D3, col. 5,
`
`|. 53-61).
`
`Moreover, claim 1 covers any amount of bunching up of the fabric, even a modest or small
`
`amount, and irrespective of whether or not the bunching forms flaps and pockets that extend in-
`
`to spaces formed by the native valve leaflets.
`
`Hence, features C3 and C4 are shown in D1.
`
`Thus, D1 discloses all features of claim 1 and claim 1 lacks novelty over D1.
`
`4. Lack of novelty (Art 100(a) EPC and Art. 54 EPC) over FR 2 826 863 A1 (D2)
`
`Document D2 was published on January 10, 2003, Le. prior to the alleged priority date of the
`
`patent in suit of 23.12.2003. D2 therefore constitutes prior art according to Art. 54(2) EPC.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 10 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 10 of 16
`
`

`

`
`
`11
`
`
`
`mm:
`
`'Y1 '
`
`
`
`
`
`
`
`,[llofofololilr
`. .
`
`V ,
`4:010:in .
`u imam
`
`
`
`-
`
`3
`
`
`
`(P1) Apparatus for endovascularly replacing a patient's heart valve, the apparatus compris-
`
`ing:
`
`D2 discloses means and methods for replacing a heart valve in a minimally invasive manner (see
`
`p. 1, I. 1-3).
`
`Hence, D2 anticipates feature P1.
`
`(P2) An expandable anchor.
`
`D2 shows an assembly that comprises a radially expandable armature, called “stent”, with at
`
`least one zone that is expandable (see p. 1, l. 1-3).
`
`Hence, D2 anticipates feature P2.
`
`(P3) Supporting a replacement valve.
`
`Furthermore means to mount a valve on the stent are shown in D2 (see p. 2, I. 11-13).
`
`Hence, D2 anticipates feature P3.
`
`(P4) The anchor having a delivery configuration and a deployed configuration, character-
`
`ized by
`
`Since the radially expandable armature is expandable as described above, it has at least two con-
`
`figurations. The deployed configuration ("état expansé”) is described on p. 2, |. 6—10 and a deliv-
`
`ery configuration ("état de non-expansion”) of the anchor is shown in figure 5 and on p. 7, l. 17-
`18.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 11 of 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 11 of 16
`
`

`

`12
`
`Hence, D2 anticipates feature P4.
`
`(C1 ) A fabric seal.
`
`The assembly of D2 comprises a sheath ("gaine 3”). This sheath is made of a biocompatible, im-
`
`permeable material such as Dacron (p. 10,
`
`I. 25-28). Dacron is a commonly utilized fabric in
`
`cardiac surgery (see D4, col. 3,
`
`|. 47). This sheath is a means for sealing between the stent and
`
`the wall of the vessel (p. 5, l. 21 —22).
`
`Hence, D2 anticipates feature C1.
`
`(C2) Extending from the distal end of the valve (20) proximally over the anchor in the de-
`
`livery configuration,
`
`The wording “extending from the distal end of the valve proximally” includes a seal which in-
`
`cludes a part located close to a distal end of a valve and extends directly proximally without cir-
`
`cling the distal end of the anchor. “Over the anchor” is anticipated by a seal simply covering a
`
`radially exterior side of the anchor.
`
`In the patent in suit in the implanted state a proximal direction points from the aorta to the left
`
`ventricle.
`
`In contrast, D2 defines proximal direction to point from the left ventricle to the aorta
`
`(p. 8,
`
`I. 15-20). Therefore the proximal end of a valve 4 in D2 is equivalent to the distal end of
`
`the valve in the patent in suit. Hereinafter, for the sake of simplicity, the directions proximal and
`
`distal are utilized according to the convention of the patent in suit.
`
`The sheath 3 in D3 extends over the radially exterior side of the anchor from a distal end of the
`
`stent to a proximal end of the stent (figs. 9). The valve 4 is mounted in a region 10 (fig. 1) within
`
`the stent. Thus, the sheath also extends from the distal end of the valve proximally over the an-
`
`chor. Since the sheath is fixed to the stent with seams, it is implicitly understood that the sheath
`
`is mounted before the implantation (p. 10, I. 30-34).
`
`Thus,
`
`it extends proximally over the anchor
`
`in the delivery configuration ("état de non-
`
`expansion”) as required by claim 1.
`
`Hence, D2 anticipates feature C2.
`
`(C3C4)
`
`Wherein the seal is bunched up in the deployed configuration.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 12 of 16
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`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 12 of 16
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`

`

`13
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`in D2 the sheath 3 may be considered "bunched up in the deployed configuration” in any or all
`
`of the following ways:
`
`First, when the stent is deployed it foreshortens as seen in figures 5 to 7. The stent compriSes
`
`hooks 15 (p. 9,
`
`I. 15—16). The hooks 15 are inserted into the wall of vessel upon deployment
`
`(p. 9,
`
`I. 25-27). Upon an expansion of the stent the stent foreshortens such that the hook is
`
`pushed outwards, as can be seen from figures 5 to 7. Since the sheath 3 is fixed to the stent with
`
`seams, it will be stretched in a circumferential direction. In the longitudinal direction the stent is
`
`foreshortened such that within the orifices excessive material will bunch up during deployment.
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`Secondly, the sheath 3 contains flaps 40 and 42 (see figs. 2 and 10) which are folded over sheath
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`3 in both configurations. The folded flaps are bunched up.
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`Thirdly, within the flaps 40 and 42 there are inflatable chambers 41 and 43. These chambers
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`may be inflated when the stent is in the deployed configuration to form a tight seal between the
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`sheath and the wall of the ventricle (p. 11, l. 1-2). Thus, the champers are bunched up in a de-
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`ployed configuration.
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`Hence, D2 anticipates features C3 and C4.
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`Thus, D2 discloses all features of claim 1 and hence claim 1 lacks novelty over D2.
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`5. Lack of novelty over WO 2003/047468 A1 (05)
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`Document D5 was published on 18 October 2001, Le. prior to the alleged priority date of the
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`patent
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`in suit of 23 December 2003. D5 therefore constitutes full prior art according to
`
`Art. 54(2) EPC.
`
`Fig. 6
`
`
`
`
`aur-
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`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 13 of 16
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`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 13 of 16
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`

`

`14
`
`(P1) Apparatus for endovascularly replacing a patient's heart valve, the apparatus compris-
`
`ing:
`
`D5 discloses expandable heart valve prostheses, especially for use in minimally—invasive surgeries
`
`(see p. 1,
`
`l. 5), and introduction via the patent’s vasculature and to the aorta (see p. 17,
`
`|. 4—5;
`
`page 17, |. 12-14; and Figs. 16a-c).
`
`Hence, D5 anticipates feature P1.
`
`(P2) An expandable anchor.
`
`The valve prosthesis includes a tissue engaging base 104 (embodiment of Figs. 6-15). The tissue
`
`engaging base 104 is said to be radially compressed and delivered through a catheter or cannula
`
`(see p. 12,
`
`I. 19-21). The tissue engaging base 104 is radially expandable for deployment (see
`
`p. 18, |. 22-23; and Fig. 16C).
`
`Hence, D5 anticipates feature P2.
`
`(P3) Supporting a replacement valve.
`
`The valve prosthesis further comprises a valve in the form of prosthetic leaflets (108) mounted on
`
`a wireform 106 (see p. 12, I. 27-28), as part of leaflet sub—assembly 102. The sub-assembly 102
`
`is coupled to the base 104 (see p. 13, lines 31-32).
`
`Hence, D5 anticipates limitation P3.
`
`(P4)
`
`The anchor (20) having a delivery configuration and a deployed configuration, character-
`
`ized by
`
`As already described, the tissue engaging base 104 is radially compressible, and expandable. The
`
`tissue engaging base thereby has a compressed and an expanded configuration.
`
`Hence, P4 is shown in D1.
`
`(C1 )
`
`A fabric seal.
`
`The leaflet subassembly 102 comprises a fabric skirt 110 (see p.12, |. 28; Figs. 6, 12, and 16c).
`
`‘
`
`Upon implantation, the fabric skirt 110 is captured between the tissue engaging base 104 and
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 14 of 16
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`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 14 of 16
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`

`

`15
`
`the surrounding tissue. The fabric skirt forms a flow channel for blood entering the inflow end of
`
`the valve (see p. 18, I. 27-31). The fabric skirt thereby avoids leakage of blood around the pros-
`
`thesis, and acts as a seal.
`
`Hence, feature C1 is shown in D5.
`
`(C2)
`
`extending from the distal end of the valve (20) proximal/y over the anchor in the
`
`delivery configuration.
`
`In claim 1 of the patent in suit, the references to "distal" and “proximal” do not have any limiting
`
`effect because claim 1 does not define any point of reference with respect to which something
`
`may be considered "proximal" or "distal". The claim language merely defines features of a heart
`
`valve, and in such case it is in fact conventional to refer to the patient’s heart as the point of ref-
`
`erence. However,
`
`in the absence of any specific definition or medical indication of the valve in
`
`the claim (the claim covers any kind of heart valve), these terms are understood merely to be la-
`
`bels, defining opposite ends and directions of the prosthesis.
`
`As can be clearly observed from Fig. 6, assuming the upper end of the valve to be a "distal" end,
`
`and the lower end of the valve to be a "proximal" end, then the skirt 110 extends from the up-
`
`per (distal) region of the valve leaflets 108 downwardly (proximally) over the tissue engaging
`
`base 104. Such disposition of the skirt 110 occurs in all assembled states of the prosthesis,
`
`in-
`
`cluding the delivery configuration. Hence, C2 is shown in D1.
`
`(C3/C4)
`
`wherein the seal is bunched up in the deployed configuration.
`
`Referring to Fig. 12, and the annotated copy below (in which the fabric 110 is emphasized in
`
`black), the fabric 110 is bunched—up at the junction with the leaflets 108:
`
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 15 of 16
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`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 15 of 16
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`

`

`16
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`In particular, the fabric 110 includes a tight 180° fold around the wireform 106, and an adjacent
`
`tight 180° back—fold around the leaflet 108. The folds are pulled tight by stitching 182, forming
`
`the bunched-up shape of the fabric with folds and pockets (see p. 15, I. 18-22). One pocket re-
`
`ceives the leaflet edge; another pocket receives the wireform.
`
`The bunching shown in Fig. 12 is carried out during manufacture of the leaflet sub-
`
`assembly 102. Therefore, the bunched-up fabric is present in all configurations of the prosthesis,
`
`including the deployed configuration as defined in feature C4.
`
`Hence, features C3 and C4 are shown in D5.
`
`Thus, D5 discloses all features of claim 1 and claim 1 lacks novelty over D5.
`
`6. Lack of inventive step (Art 100(a) EPC and Art. 56 EPC) over WO 98/29057 A1 (D1) or
`
`FR 2 826 863 A1 (D2)
`
`Should the Opposition Division come to the conclusion that claim 1
`
`is novel over D1, D2 and
`
`D5, then the objection of lack of inventive step is not a fresh ground for opposition and can con-
`
`sequently be examined without the agreement of the patentee according to the principles set
`
`forth in T 131/01.
`
`In addition to the documents already referred to above, document D6 may be referred to. For
`
`example, document D6 shows that a heart valve replacement procedure may be carried out
`
`endovascularly either via a retrograde approach (see Figs. 20-22) or via an antegrade approach
`
`(see Fig. 11).‘
`
`VII. DEPENDENT CLAIMS
`
`Even if lack of novelty and lack and inventive step in the present reasons for opposition have not
`
`been discussed in detail with respect to the dependent claims, the dependent claims are implicitly
`
`covered by the extension of grounds relating to the independent claims (see (39/91).
`
`Furthermore, the dependent claims only refer to features which are known from D1, D2 or D5 or
`
`which are obvious for a skilled person in the art.
`
`/ '
`/
`W car—7
`
`Dr. Isabel Tomerius
`
`Patentanwaltin
`
`.
`
`Enclosures:
`
`D1 WO 98/29057 A1
`D2
`FR 2 826 863 A1
`D3 us 5,957,949 A
`D4 us 4,084,268 A
`D5 wo 01/76510 A2
`
`D6 US 2002/0032481 A1
`
`D7 Extract from online Macmillan dictionary
`EPO Form Payment of Fees
`Copy of Opposition with D1 to D7
`
`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 16 of 16
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`Edwards Lifesciences Corporation, et al. Exhibit 1151, Page 16 of 16
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`