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`PETERREINS SCHLEY
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`PATENT ATTORNEYS AND ATTORNEYS AT LAW
`
`Peterreins Schley · Patent- und Rechtsanwälte GbR · Hermann-Sack-Straße 3 · 80331 Munich
`
`
`
`District Court of Düsseldorf
`– Patent Litigation Division –
`Werdener Strasse 1
`
`40227 Düsseldorf
`
`
`
`We will serve
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`Munich, August 24, 2016
`Our ref.: 31316-3000LL1
`
`
`4a O 137/15
`
`In the matter
`
`
`
`Peterreins Schley
`Patent- und Rechtsanwälte GbR
`
`Hermann-Sack-Straße 3
`80331 Munich
`Germany
`
`Tel.: +49 (89) 8091338-00
`Fax: +49 (89) 8091338-88
`Email: info@ps-patent.com
`www.ps-patent.com
`
`Dr. Frank Peterreins 1,2,3
`
`Dr. Jan-Malte Schley 2,3
`Markus Coehn 2,3
`Felix Glöckler 2,3
`Dr. Matthias Traut 2,3
`Patrick Wiedemann 2,3
`
`
`
`
`
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`
`
`1 Attorney at law
`2 Patent attorney
`3 European patent attorney
`
`v.
`
`
`Edwards Lifesciences Corp. et al.
`(Bird & Bird)
`
`
`Boston Scientific Scimed, Inc.
`(Peterreins Schley)
`
`
`
`
`A. On the Defendants’ preamble
`
`In their preamble, the Defendants present a number of things confusingly and sometimes even
`incorrectly. The following clarifying comments are therefore required:
`
`A.I On the company history of the Defendants
`
`The company of Defendant 1 was founded in 1958 and was initially involved in developing a
`ball-cage prosthesis (see figure in paragraph 4 of the statement of defense), which was
`implanted into a human for the first time on September 21, 1960. What was not mentioned was
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 1 of 70
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`that, back in 1951, in other words almost 10 years earlier, Charles Hufnagel described a ball-
`cage prosthesis which was implanted in a human for the first time on September 11, 1952. Also
`left unmentioned in the statement of defense were numerous ball-cage prostheses developed at
`the same time, such as the Harken-Soroff ball-cage prosthesis (first implanted in March 1960),
`the Braunwald-Cutter ball-cage prosthesis (first implanted on March 11, 1960), the Magovern-
`Cromie ball-cage prosthesis (first implanted in 1962), the Smeloff-SCDK-Cutter ball-cage
`prosthesis (first implanted in 1964) and the DeBakey ball-cage prosthesis (first implanted in
`1969).
`
`With reference to their ball-cage prosthesis, the Defendants mention patent specification
`DE 1 491 148 B filed by the company founders Miles Lowell Edwards and Albert Starr, but
`this is completely irrelevant to the present proceedings. Firstly, the patent is aimed at a special
`embodiment of a thimble (see claim 1 and the figures) which is used to stitch the ball-cage
`prosthesis at the implantation site, the mitral valve. It is therefore a prosthesis that is to be
`surgically implanted in order to replace the mitral valve. The reference in paragraph number 5
`to a similarity between the thimble and the claimed invention is completely unfounded because
`the claimed apparatus for endovascular replacement of the heart valve does not have a thimble,
`nor is a seal produced through the stitching. Secondly, the irrelevance of patent specification
`DE 1 491 148 B is evident simply from the fact that the Defendant did not introduce this
`document as state of the art in the (ongoing) opposition proceedings before the European Patent
`Office, nor does it refer to it in its petition for a staying of proceedings.
`
`The founding of the company Percutaneous Valve Technologies (PVT) cannot represent a
`milestone in the company history of the Defendants either because the Defendant only took
`over the company in 2004. In addition, PVT was founded back in 1999 and not in 2001 as stated
`by the Defendant.
`
`In the statement of defense, an attempt is made to give the impression that Defendant 1
`developed the first transcatheter valves (see paragraphs 7 to 11 of the statement of defense).
`However, this cannot be accepted because the development of transcatheter valves had already
`begun decades before its takeover of PVT and also before the founding of PVT. This is because
`catheter-based valve prostheses which can assume the function of the aorta valve had been
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 2 of 70
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`described, inter alia, back in 1965 by Davies, in 1971 by Moulopoulos, in 1976 by Phillips and
`in 1977 by Boretos and Poirier.
`
`In 1989, the Danish cardiologist Henning Rud Andersen managed to implant an aorta valve
`prosthesis that permanently remained at the implantation site in a pig using a catheter. In the
`years thereafter, various valve prostheses were developed, such as the Pavcnik transcatheter
`ball-cage prosthesis (1992), the Stevens valve prosthesis (1994) and the Sochman transcatheter
`disc prosthesis (2000), which were likewise tested in an animal model. In 2000, Philip
`Bonhoeffer finally managed the first implantation of a transcatheter valve to replace the
`pulmonary valve in a human. Only two years later, on April 16, 2002, Cribier, one of the
`founders of PVT, carried out the first implantation of a transcatheter valve to replace the aorta
`valve in a human. And only after numerous further implantations in humans did the Defendant
`take over the company PVT in 2004.
`
`The assertion made by the Defendants that Cribier developed "transcatheter aorta valve
`implantation" is therefore incorrect. Although he may have been the first to carry out such
`surgery on a human, the method itself had long been known by that time and had been
`established in an animal model.
`
`The Defendants therefore played a much smaller part in the development of transcatheter heart
`valves than their statements suggest. At best, the Defendants can be credited with successfully
`marketing the transcatheter aorta valve developed by Cribier which was initially distributed by
`the Defendants as the Cribier-Edwards Valve.
`
`A.II On the company history of the Plaintiff
`
`Boston Scientific Corporation is one of the world's leading medical engineering companies and
`develops innovative products, amongst other things, for the diagnosis or treatment of
`cardiovascular, stomach, lung, urological, gynecological and neurological diseases. Boston
`Scientific, as an innovative company, is regularly named as being at the forefront in statistics
`published by the European Patent Office. For example, in 2015, with 260 applications, Boston
`Scientific was ranked 6th in the field of medical engineering and, with 173 granted patents, was
`ranked 46th out of all filers of European patent applications.
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 3 of 70
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`In 2011, Boston Scientific took over the company Sadra Medical founded in 2003 and then
`made the Lotus valve prosthesis ready for the market.
`
`A.III On the problem of paravalvular leakage
`
`One of the main problems that can arise after implanting heart valve prostheses is that, unlike
`healthy heart valves, they do not completely prevent the backflow of blood. Instead, because of
`leaks, a slight backflow of blood occurs. The backflow may be through the valve prosthesis
`itself (what is referred to as "transvalvular leakage") or through spaces between the valve
`prosthesis and the aortic annulus (what is referred to as "paravalvular leakage") and may occur
`with heart valve prostheses which are surgically implanted in exactly the same way as with
`transcatheter valves.
`
`In the case of valve prostheses which are surgically implanted, the problem of paravalvular
`leakage was largely solved by improving the fit of the thimble. However, this type of solution
`is not possible with transcatheter valves because they do not have a thimble and they are also
`supplied with the smallest possible diameter on a catheter.
`
`The company Sadra Medical taken over by Boston Scientific Corporation carried out intensive
`research early on in an attempt to find solutions to prevent or reduce paravalvular leakage in
`transcatheter valves. PCT application WO 2005/065585 A1 ("Salahieh") which was published
`on July 21, 2005 and underlies the patent in suit describes a number of possible ways of sealing
`a transcatheter valve against paravalvular leakage, including a seal which bunches up and sacs
`arranged around the outside of the prosthesis.
`
` A
`
` seal developed by Sadra Medical to prevent paravalvular leakage was described in the
`scientific literature in 2008. The seal referred to as “Adaptive Seal Technology” was described
`in the article entitled "Percutaneous Implantation of The First Repositionable Aortic Valve
`Prosthesis in a Patient With Severe Aortic Stenosis" by Lutz Buellesfeld et al. published in the
`journal "Catheterization and Cardiovascular Interventions" on March 24, 2008. This article and
`a German translation thereof are submitted as:
`
`– Exhibits PS8a and PS8b –.
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 4 of 70
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`It says in this article that a paravalvular leakage occurs in up to 47% of cases owing to
`incomplete paravalvular sealing (page 580, middle of the right-hand column). In order to solve
`this problem, a flexible seal around the outer surface of the lower part of the prosthesis is
`described (page 581, left-hand column, last paragraph):
`
`
`"At the outer surface, the lower part of the prosthesis is surrounded by a flexible sealing
`membrane (Adaptive SealTM) made of polyurethane, which fills potential gaps between
`the prosthesis and the native valve in the final compressed state of the device to minimize
`or even eliminate paravalvular leakage."
`
`The Lotus valve prosthesis, which uses Adaptive Seal Technology, has had CE approval since
`October 2013 and is extolled in the scientific literature for its extremely efficient sealing against
`paravalvular leakage.
`
`In the latest generation of the Sapien valve prosthesis, the Sapien 3 valve prosthesis contested
`here, Defendant 1 has now also added a flexible seal around the lower part of the outer surface.
`The previous version, Sapien XT, which is currently still being marketed by the Defendants,
`has no such seal around the lower part of the outer surface:
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` Sapien 3
`
` Sapien XT
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`This change and the effects thereof are described as follows in the approval documents of the
`US
`licensing authority
`the FDA
`(available at http://www.fda.gov/MedicalDevices/
`ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/
`ucm455223.htm):
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 5 of 70
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`"The SAPIEN 3 THV is the third generation of the SAPIEN THV that FDA originally
`approved in 2011. The device has a major design change that adds a skirt at the base
`of the valve frame to minimize leakage around the valve."
`
`The Sapien 3 valve prosthesis therefore has much lower paravalvular leakage than the Sapien
`XT valve prosthesis owing to the flexible seal added.
`
`Defendant 1 only received CE approval for the Sapien 3 valve prosthesis in January 2014, in
`other words more than eight years after publication of the PCT application underlying the patent
`in suit and nearly six years after publication of the article according to Exhibit PS8a/b.
`
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 6 of 70
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`B. On the subject matter of the patent in suit
`
`In their statement of defense, the Defendants present the subject matter of the patent in suit
`incorrectly in numerous respects. In particular, the attempt made by the Defendants to interpret
`the patent claims more narrowly its the wording is impermissible. The following comments
`therefore need to be made:
`
`B.I Repositionability is irrelevant
`
`The patent in suit relates to an apparatus for endovascularly replacing the heart valve of a patient
`which has a seal (as defined in the patent claims). This is apparent merely from paragraphs 1
`and 17 of the patent in suit (Exhibit PS1b). However, contrary to the opinion expressed by the
`Defendants, the aspect of repositionability during implantation described in the patent in suit is
`completely irrelevant to the patent claims asserted.
`
`
`The description of the patent in suit contains several additional advantageous and inventive
`aspects. As a result, the European Patent Office has already granted a total of 13 patents in the
`patent family related to the patent in suit. However, these additional aspects, such as the aspect
`of repositionability, are not the subject matter of the patent claims of the patent in suit. As a
`result, neither repositionability nor the structural or design features intended to achieve
`repositioning during implantation are mentioned in the patent claims.
`
`The aspect of repositioning is described in the patent in suit in connection with a "deployment
`tool" or a "delivery system", that is to say, in particular, a catheter which can "actively
`foreshorten" a self-expandable anchor (see paragraphs 24 to 36 of the patent in suit and Figures
`1A to 4F, in particular paragraph 25 of the patent in suit). For this purpose, the anchor may
`optionally be provided with interlocking elements 42, 44 to lock a self-expanding heart valve
`implant according to Figures 1A to 4F in the expanded state (see in respect hereof, in particular,
`paragraph 29 of the patent in suit). Locking in the expanded state is advantageous in self-
`expandable anchors so that the anchor can permanently retain a high radial strength (see in
`respect hereof also patent in suit, paragraphs 27 and 28).
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 7 of 70
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`However, the patent in suit expressly clarifies that, instead of self-expandable anchors, balloon-
`expandable anchors can also be used, see in particular paragraph 23:
`
`
`
`"Anchor 30 preferably is fabricated by using self-expanding patterns (laser cut or
`chemically milled), braids, and materials, such as a stainless steel, nickel titanium
`("Nitinol") 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 of balloon expansion."
`
` A
`
` balloon-expandable anchor is also mentioned in patent claim 12 of the patent in suit. Such an
`anchor essentially cannot be repositioned during implantation because a balloon catheter
`presses the anchor radially outward from inside and in the process plastically deforms the struts
`of the anchor. If the pressure is released from the balloon, then the anchor remains in its radially
`expanded position (possibly with a slight reduction in diameter because the natural tissue
`presses against the anchor from outside).
`
`Repositionability and the interlocking of the anchor are therefore at best advantageous
`secondary aspects if a self-expandable anchor according to patent claim 11 is used. However,
`these secondary aspects are unnecessary if a balloon-expandable anchor according to patent
`claim 12 is used. The patent claims asserted are therefore not limited to repositionable anchors.
`
`In paragraphs 4 to 15, the patent in suit quite generally specifies drawbacks of implants
`according to the state of the art. The description of the patent in suit also specifies several ways
`of overcoming these drawbacks. However, these ways, such as the possibility of repositioning
`and the interlocking of a self-expandable anchor, have no connection with the object of
`achieving improved sealing or reducing the undesirable backflow of blood.
`
`Also to be understood against this background is paragraph 16 of the patent in suit according
`to which it is desirable to provide methods and devices that overcome drawbacks in the state of
`the art. However, as is clearly stated in paragraph 17 of the patent in suit, the present invention
`relates to the aspect of sealing. The object of the patent in suit therefore does not consist in
`overcoming all of the drawbacks of the state of the art as the Defendants believe.
`
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 8 of 70
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`B.II On Features 1 to 3
`
`In their statement of defense the Defendants ultimately confirm the Plaintiff's interpretation of
`Features 1 to 3 and do not dispute the use thereof in the Sapien 3 heart valve implant either. As
`a result, no further comments are required in respect hereof.
`
`It is merely mentioned by way of clarification that the anchor according to the invention can
`consist not only of a (self-expandable) plaited framework (see paragraph 30 of the statement of
`defense). Instead, as mentioned, balloon-expandable anchors can also be used (see in particular
`paragraph 23 and patent claim 12), as is the case in the contested embodiment.
`
`B.III On Feature 3.2
`
`1.
`In patent claim 1 (and in paragraphs 17, 62, 99 and 103 of the patent in suit), the verb
`"bunched up" was correctly translated as "aufgebauscht". Our breakdown of features will
`therefore be retained. Conversely, the Defendants' translation as "zusammengeschoben"
`("pushed together") is merely motivated by the desire to arrive at a narrower interpretation of
`Feature 3.2 ("wherein the seal is bunched up in the deployed configuration").
`
`According to the PONS, Collins/PONS and Reverso dictionaries, "bunch up" is translated into
`German as "bauschen", "sich bauschen" or "aufbauschen". The corresponding extracts are
`submitted as:
`
`– Exhibits PS9a, PS9b and PS9c –.
`
`
`It is well known that the English adverb "up" can be translated as "auf", so "aufbauschen" is a
`correct translation of "bunch up", the meaning of the verbs "bauschen" and "aufbauschen" in
`any case being the same in the present case. However, "bunch out" is also translated as
`"hervortreten" according to Exhibit B7 submitted by the Defendants.
`
`2.
`For the purpose of claim constructions, Defendants rely on a “Google Picture search”.
`However, results of a “Google Picture search” are not admissible for claim construction.
`Besides that, there was no “Google Picture Search” available on the priority date (Dec. 23,
`2003) of the patent-in-suit.
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 9 of 70
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`The correct meaning of the verb "bunch up" is highly dependent on the context. In the case of
`a gathering of people, "bunch up" can certainly be translated as "ein Grüppchen bilden" ("form
`a group"). However, the translation "ein Grüppchen bilden" is certainly not appropriate in the
`present case. As a result, also the synonyms and examples given in Exhibits B8 and B9 are
`irrelevant to the specific context. The present case is not about socks or trousers that have been
`pulled down, so the (inadmissible) Google Picture search carried out by the Defendants
`according to Exhibit B10 is meaningless. The Defendants have also presented only a selection
`of the images from their "search". The following image from the Google Picture search (for
`"bunch up") shows that, in the area of textiles, bunching up can also occur without the textile
`being pushed together:
`
`
`In any case, the translation "zusammenschieben" suggested by the Defendants is incorrect. The
`verb "zusammenschieben" is translated into English as "push together" and not "bunch up". As
`
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 10 of 70
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` a
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` result, the verb "zusammenschieben" is not mentioned at all even in Exhibit B7 submitted by
`the Defendants. Exhibit B8, to which the Defendants refer in relation hereto, merely contains
`an explanation of an example on a possible cause for a bunching up.
`
`3.
`There is no legal definition of the term "bunched up seal" in patent in suit. Nor is it a
`common technical term because a bunched up seal was not known in the state of the art in the
`field of heart valve implants. The term "bunched up seal" is therefore to be interpreted in a way
`that is reasonable given the technical function it is supposed to carry out according to the
`inventive concept disclosed.
`
`a)
`According to Feature 3.2, all that is required is that the seal be bunched up in the
`deployed configuration, in other words that it lie loosely on the outer surface of the expandable
`anchor, so that the seal can fill spaces between the anchor and the natural heart valve in order
`to reduce or prevent any paravalvular leakage. The seal must therefore, as far as it is located on
`the outside of the anchor, have excess material so that it can be spaced at least partially away
`from the outer surface of the anchor. This function follows from paragraphs 62 and 103 of the
`patent in suit.
`
`The "spaces" specified in paragraph 62 comprise here any type of spaces or gaps which are
`formed by the natural valve leaflets ("… spaces formed by the native leaflets"), e.g. through
`irregularities resulting from calcification on the valve leaflets. The material of the seal therefore
`does not necessarily have to fill a space between two neighboring natural valve leaflets (as the
`Defendants say in paragraph 136 of their statement of defense).
`
`b)
`The Defendants are of the opinion that the seal should supposedly only be bunched up
`in the deployed (expanded) configuration, not in the delivery configuration (see paragraph 52
`of the statement of defense). However, this opinion is incorrect.
`
`(1)
`The wording of Feature 3.2 refers only to the (bunched up) state of the seal in the
`deployed (expanded) configuration of the anchor. The form of the seal in the delivery
`configuration of the anchor, however, is left open in patent claim 1. Paragraph 62 of the patent
`in suit also refers only to the deployed state. In this respect, the Defendants also translate
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 11 of 70
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`paragraph 62 of the patent in suit incorrectly in their statement of defense (see paragraph 54).
`This is because the phrase:
`
`
`"when deployed, as shown in Figures 23 and 24, fabric seal 380 bunches up …"
`
`
`should in fact be translated as follows (the words in square brackets have been added to the
`translation according to Exhibit PS1b):
`
`
`
`"Eingesetzt [oder wenn eingesetzt], wie in den Figuren 23 und 24 gezeigt, bauscht sich
`die Abdichtung 380 aus Gewebe auf, …"
`
`
`The Defendants' translation "Beim Einsetzen" (see paragraph 54 of the statement of defense)
`would only be correct if the English version of the patent in suit said "During deployment"
`(which is not the case). As a result, feature 3.2 in fact only refers to the configuration of the seal
`in the deployed state.
`
`(2)
`Nor is the Defendants' opinion confirmed by the breakdown of features (see
`paragraph 53 of the statement of defense). The fact that Feature 3.2 only refers to the bunched
`up form of the seal in its deployed state completely precludes the contrary argument that the
`seal has to lie taut on the outside of the anchor in the delivery configuration of the anchor. As
`mentioned above, claim 1 contains no limitation on how the form of the seal has to be
`configured in the delivery configuration.
`
`(3)
`The Defendants make further reference to Figures 22 and 23 of the patent in suit.
`However, these figures are only schematic representations of an exemplary embodiment.
`Nowhere in paragraph 62 of the patent in suit does it say that the seal has to lie taut on the
`outside of the anchor in the delivery configuration of the anchor. This fact alone demonstrates
`that the form of the seal in the delivery configuration is of no particular significance. The sealing
`function instead depends on the deployed (expanded) configuration of the anchor. This is
`because the sealing effect is only produced in the implanted state of the heart valve implant.
`
`Notwithstanding the above, the Defendants overlook the fact that it is not just the exemplary
`embodiment according to Figures 22 to 24 that shows a seal according to the invention, but also
`the exemplary embodiment according to Figures 29A to 29C (see also paragraphs 97 to 99 of
`the patent in suit, in particular paragraph 99, second sentence). In Figure 29A, the anchor 30 is
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 12 of 70
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`shown in the partially expanded state (see right-hand side) and partially in the delivery
`configuration (left-hand side of the anchor 30 in direct connection with the outlet from the
`catheter 600):
`
`
`
`Figure 29A of the patent in suit
`
`
`The seal 60 is at least partially spaced away from the outside of the anchor both in the expanded
`area of the anchor and immediately after the outlet from the catheter (corresponding to the
`delivery configuration of the anchor).
`
`Contrary to the Defendants' opinion, the form of the seal in the delivery configuration is
`therefore left open in patent claim 1.
`
`c)
`The Defendants are also of the opinion that the bunching up of the seal supposedly has
`to occur through a "considerable axial foreshortening of the anchor by 50% or more" (see
`paragraphs 58 and 61 of the statement of defense). This opinion is also incorrect.
`
`(1)
`The wording of patent claim 1 does not require any foreshortening of the anchor in order
`to produce bunching up. It is difficult to see how the Defendants are able to read a "considerable
`foreshortening by 50% or more" into Feature 3.2 ("wherein the seal is bunched up in the
`deployed configuration"). A foreshortening of the anchor per se, i.e. without any amount being
`specified, is only mentioned in dependent patent claim 9.
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 13 of 70
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`(2) By way of justification, the Defendants refer to paragraph 103 and to Figures 22 and 23
`of the patent in suit, wherein the Defendants have again translated the verb "bunch up"
`incorrectly as "zusammenschieben" ("push together") in their German translation (see
`paragraph 59 of the statement of defense).
`
`As already explained in paragraph B.I above, an axial foreshortening during the expansion of a
`self-expandable anchor is advantageous in order to achieve greater radial strength (see patent
`in suit, paragraphs 27 and 28, in particular paragraph 28, sentence 3). However, in paragraph
`23, the patent in suit expressly clarifies that, instead of self-expandable anchors, balloon-
`expandable anchors can also be used. A balloon-expandable anchor is pressed radially outward
`from inside during implantation with the aid of a balloon catheter, the struts of the anchor
`plastically deforming. The main deformation therefore takes place here in a radial direction (i.e.
`from the inside out), a certain axial foreshortening possibly but not necessarily taking place.
`
`Figures 22 and 23 only show an exemplary embodiment in which foreshortening takes place
`(as incidentally is also the case in the contested embodiment, see Section C.I.2 below).
`However, the subject matter of the patent in suit is not limited to heart valve implants in which
`the anchor has to foreshorten, and certainly not by 50% or more.
`
`For example, it is also stated in connection with the exemplary embodiment according to
`Figures 29A to 29C that foreshortening is only optional, see paragraph 99, sentence 2 of the
`patent in suit (emphasis added):
`
`
`
`(3)
`The person skilled in the art neither finds a confirmation of the Defendant’s
`understanding in paragraphs 71 to 73 of the patent in suit.
`
`It is made clear throughout paragraphs 71 and 72 that the dimensions specified are just
`preferred, that is to say in connection with self-expandable anchors, because paragraphs 71 and
`72 refer to paragraph 70 which talks about a self-expandable anchor.
`
`Paragraph 73 of the patent in suit likewise describes the optional nature of the length ratios
`given (in connection with self-expandable anchors) (emphasis added):
`
`"Foreshortening can cause seal 60 to bunch up and create pleats."
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`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 14 of 70
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`"Overall, the ratio of deployed to collapsed/sheathed lengths is preferably between
`about 0.05 and 0.5."
`
`
`And according to paragraph 74 of the patent in suit, the expansion of the anchor through "active
`foreshortening", that is to say through use of axial forces by the delivery apparatus to the anchor,
`is likewise only optional (emphasis added):
`
`
`
`"As seen in Figure 25B, anchor 30 may be expanded to a fully deployed configuration
`from a partial deployed configuration (e.g., self-expanded configuration) by actively
`foreshortening anchor 30 during endovascular deployment. In some embodiments,
`foreshortening of the apparatus involves applying a distally directed force on the
`proximal end of the anchor by one or more anchor actuation elements to move the
`proximal end of the anchor distally, while maintaining the position of the distal end of
`the anchor."
`
`
`In particular, an "active foreshortening" is unnecessary in balloon-expandable anchors. As a
`result, paragraph 74 of the patent in suit also relates only to "some embodiments".
`
`d)
`The Defendants also believe that, according to Feature 3.2, a "circumferential fall of the
`pleats in horizontal alignment" supposedly has to be brought about (paragraphs 60, 65, 71 and
`73 of the statement of defense). This opinion is also incorrect. No fall of the pleats in horizontal
`alignment is specified in the asserted patent claims (in particular in Feature 3.2).
`
`The Defendants refer in this respect to the exemplary embodiment according to Figure 23 of
`the patent in suit. However, Figure 23 is only a schematic representation of an exemplary
`embodiment intended to show possible bunching up. As Figure 23 shows the seal 380 on the
`outside of the anchor in cross section, an exclusively horizontal alignment cannot be seen. The
`Defendants merely interpret a horizontal alignment as existing in Figure 23. As a result, they
`have also altered Figure 23 of the patent in suit reproduced in Exhibit B13 by adding dotted
`circumferential lines.
`
`No mention is made in paragraphs 62, 99 or 103 of the patent in suit of the fact that the bunching
`up has to lead to a fall of the pleats in horizontal alignment. Nor can any horizontally aligned
`pleats be seen in the exemplary embodiment with a bunched up seal according to Figures 29A
`to 29C, see in particular Figure 29C of the patent in suit:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 15 of 70
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`– 16 –
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`Figure 29C of the patent in suit
`
`
`
`
`e)
`The Defendants are of the opinion that bunching up according to Feature 3.2 would
`require a formation of pleats corresponding to the pictures in Exhibit B15 (see paragraphs 75
`to 78 of the statement of defense). This opinion is again incorrect. No pleats are specified in the
`asserted patent claims (in particular in Feature 3.2).
`
`No pleats can be seen in Figures 22 to 23 or 29A to 29C of the patent in suit either, which
`correspond to the pictures in Exhibit B15, in particular no bent pleats with sharp angles. The
`(inadmissible) Google Picture search is also irrelevant here. Such pleats with sharp angles
`occur, for example, when paper is folded. In textiles, such pleats with sharp angles can only be
`achieved through corresponding treatment (for example by applying pressure and/or heat).
`
`However, the description of the patent in suit does not say that the bunched up seal has to have
`pleats with sharp angles (corresponding the pictures in Exhibit B15). Instead, from a functional
`perspective, it is only necessary for the seal to rest loosely on the outer surface of the expandable
`anchor so that the seal can fill spaces between the anchor and the natural heart valve.
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1132, Page 16 of 70
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`– 17 –
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`f)
`The Defendants are finally also of the opinion that Feature 3.2 supposedly requires a
`positioning of the bunched up seal level with the native valve leaflets (see paragraphs 79 to 83
`of the statement of defense). This opinion held by the Defendants is also incorrect.
`
`First of all, patent claim 1 contains no limitation on how the heart valve implant should be
`deployed or positioned. In particular, no requirement is made that the bunched up seal according
`to Feature 3.2 lie level with the native valve leaflets.
`
`Notwithstanding the above, patent claim 1 of the patent in suit is a product claim. The question
`of whether a specific use can avoid being regarded as a patent infringement was answered in
`the negative by the Federal Supreme Court in its "Rangierkatze" decision