throbber
EDWARDS v BOSTON
`
`27 JANUARY 2017
`
`PROCEEDINGS DAY 7
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`IN THE HIGH COURT OF JUSTICE Claim No. HC-2015-004574
`CHANCERY DIVISION
`PATENTS COURT
` The Rolls Building
` 7 Rolls Buildings
` London EC4A 1NL
` Fetter Lane
` Friday, 27th January 2017
` Before:
` HIS HONOUR JUDGE HACON
` (Sitting as a Judge of the High Court)
` ---------------
`BETWEEN:
` EDWARDS LIFESCIENCES LLC
` (a company incorporated under the laws of the state of
` Delaware)
` Claimant
` - and -
` BOSTON SCIENTIFIC SCIMED, INC.
` (a company incorporated under the laws of the state of
` Minnesota)
` Defendant
` - and -
` (1) EDWARDS LIFESCIENCES CORPORATION
` (a company incorporated under the laws of the state of
` Delaware)
` Third Party
` (2) EDWARDS LIFESCIENCES AG
` (also known as EDWARDS LIFESCIENCES SA)
` (a company incorporated under the laws of Switzerland)
` Fourth Party
` (3) EDWARDS LIFESCIENCES LIMITED
` Seventh Party
` ---------------
` (Computer-aided transcript of the Stenograph Notes of
` Marten Walsh Cherer Ltd., 1st Floor, Quality House,
` 6-9 Quality Court, Chancery Lane, London WC2A 1HP.
` Telephone No: 020 7067 2900. Fax No: 020 7831 6864
` e-mail: info@martenwalshcherer.com)
` ---------------
`DR. PIERS ACLAND QC and MR. MILES COPELAND (instructed by Powell
` Gilbert LLP) appeared for the Claimant.
`MR. RICHARD MEADE QC and MS. KATHRYN PICKARD (instructed by
` Olswang LLP) appeared for the Defendant.
` ---------------
` PROCEEDINGS
` DAY 7
` ---------------
`
`[Page 965]
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` PIERS ACLAND QC
`
`JUDGE HACON: Yes?
`
`MR. ACLAND: Good morning. I have two memory sticks which contain
`
`[Page 966]
`
` PIERS ACLAND QC
`
` shown in figure 16 are certainly double-walled -- two layers.
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` What this really goes to is the construction of the term
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` "disposed about the exterior of the anchor", which now,
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` although you have just been looking at the Sac Patent, is an
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` issue in the Bunched-up Patent. You want to look at the
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` bunched-up claims, claim 1. Sorry, what am I talking about?
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` That is completely off the page. The Sac Patent claims.
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`JUDGE HACON: We are back to the Sac Patent.
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`MR. ACLAND: Sorry. So it is the language at the end of claim 1,
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` "at least one sac (200) disposed about the exterior of the
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` anchor (30)." So this is what this is going to. If they are
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` double-walled the double walls both have to be outside the
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` scope of the anchor. We are talking about a sealing function,
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` whereas my learned friend's case is that in so far as
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` double-walled sacs are allowed, they can be both within and
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` without the anchor. Do you remember, fabric, metal, fabric?
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`JUDGE HACON: Yes. He says the sac presumably need not include
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` both walls.
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`MR. ACLAND: Well, I think in so far as he says a sac has two
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` walls, because of course his construction is, it does not have
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` to have necessarily two walls, it can just be a volume-filling
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` space.
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`JUDGE HACON: Well, we leave that. I do not want to take up your
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` time.
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`[Page 967]
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` PIERS ACLAND QC
`
`MR. ACLAND: Can I tell you, "disposed around the exterior of the
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` anchor", there are two submissions on that. First of all, as
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` the electronic documents.
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`JUDGE HACON: Very helpful.
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`MR. ACLAND: I am sure you do not need them right now. My Lord,
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` I have an hour left and can I tell you how I propose to use
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` that hour.
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`JUDGE HACON: Yes, please.
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`MR. ACLAND: We were dealing with construction and what I am going
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` to do is to articulate as concisely as I can what our
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` contentions are on the two patents and what we see are the
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` deficiencies with Boston's construction.
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` Now, in those circumstances it may not be fruitful to
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` spend any more time debating whether figure 15 in the
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` Sac Patent discloses double layered sacs. I will let
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` Mr. Meade explain why they are necessarily single-walled. But
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` what is clear and if you have the -- I am looking at the
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` Sac Patent.
`
`JUDGE HACON: Yes, do you want me to get that out?
`
`MR. ACLAND: Yes. So it is page 53 is the first part of figure 15
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` and then the top of page 54 is the second. So figure 15, at
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` least as far as double-walled is concerned, they are the sac
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` that you see in figure 14, or the two sacs one sees in
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` figure 14 are certainly double-walled and the sacs that are
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` a matter of ordinary English, what is "disposed about the
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` exterior"? It means that whatever is your sac needs to be
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` disposed exterior of the anchor. That is tremendously
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` straightforward. Then as a matter of purpose there is
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` a technical reason for having your sac, whatever it is,
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` disposed outside of the exterior because the sealing that one
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` is seeking to achieve is between the outside of the stent and
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` the annulus.
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` Now, Dr. Buller was cross-examined on this. The
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` references are given in our skeleton. But I can summarise the
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` point I was making which was, if you had a sac -- I will just
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` find you the references for that in our skeleton. It is
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` page 178. Do you see that? He says it is a sac. He would
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` understand the purpose to be to inflate or fill gaps between
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` the stent and the wall. He said it would therefore be nice if
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` it was situated between the anchor and the wall, otherwise
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` part of the inflation could be wasted with it blowing up on
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` the other side.
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` So, it is certainly not the case that one would not
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` achieve any space-filling properties with a sac which was both
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` inside and outside, but certainly it makes sense for it to be
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` outside in accordance with the ordinary English.
`
`MARTEN WALSH CHERER LTD
`TEL: (020) 7067 2900
`
`1ST FLOOR, 6-9 QUALITY COURT, CHANCERY LANE
`E-MAIL: info@martenwalshcherer.com
`
`LONDON, WC2A 1HP
`FAX: (020) 7831 6864
`
`[1] (Pages 0 to 967)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1146, Page 1 of 82
`
`

`

`EDWARDS v BOSTON
`
`27 JANUARY 2017
`
`PROCEEDINGS DAY 7
`
`[Page 968]
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`[Page 970]
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` PIERS ACLAND QC
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`JUDGE HACON: Okay.
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`MR. ACLAND: So that is "disposed about the exterior".
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` Now, as far as the Bunched-up Patent is concerned, so if
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` you can take claim 1 of that patent, but before we look at the
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` claim, let us just remind ourselves of the figures that depict
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` bunching-up. So it is figures 22-24 on page 47. What clearly
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` emerges from what is described there or depicted there are
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` three points which are relevant for what I am going to say in
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` relation to construction.
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` First of all the valve, 20 is right at the distal end of
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` the stent, as indeed are all the valves which are depicted in
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` PIERS ACLAND QC
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` folds getting into them.
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`JUDGE HACON: Yes, I just want to be clear where it is going. You
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` are saying if the folds are not close, that would fall outside
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` the claim.
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`MR. ACLAND: Yes. If you only had two folds, one right at the top
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` and one at the bottom ----
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`JUDGE HACON: That is what I am seeking to clarify. Are you
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` talking about the number of folds? What do you mean by "close
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` folds"?
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`MR. ACLAND: What I mean by close folds is essentially what one
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` sees in figure 24. Now, obviously that is only schematic,
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` the specification. Secondly, upon deployment, so we have two
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` deployed configurations which are 23 and then 24 when it is
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` within the native annulus, we see circumferential folds being
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` introduced. And thirdly, and this is described in the
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` specification, one can see it, that is achieved by
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` foreshortening of the stent.
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` So if we then go to the claims, and that is obviously
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` only the context, but, as I said yesterday, there is
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` a precious little to teach the skilled person what is meant by
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` bunching-up or indeed sacs in this specification. Anyway,
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` that is what is shown. Claim 1, so the first point is
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` bunched up. What would "bunched up" be understood to mean?
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` It is not a term of art and therefore we submit that the
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` but ----
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`JUDGE HACON: Just help me out a bit. Explain in regular language
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` what you mean by close folds.
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`MR. ACLAND: I mean like the sort of thing one sees in figure 23.
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`JUDGE HACON: If it is not like that, it is outside the claim; is
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` that what you mean?
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`MR. ACLAND: No, it obviously admits of variation, and plainly
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` that is only schematic, but if your Lordship puts it to me,
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` I am not suggesting it has to look exactly like that to
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` infringe.
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`JUDGE HACON: I am not trying to be difficult, Mr. Acland, but you
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` are placing emphasis on the words "close folds", so I am
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` asking you what quite do you mean? You say, figure 23, but it
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`[Page 971]
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`[Page 969]
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` PIERS ACLAND QC
`
` ordinary meaning is certainly a reasonable starting point for
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` what "bunched up" would be understood to mean. That is where
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` we turn to the dictionary. We see the dictionary, gathered
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` together into close folds.
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` The ordinary English is a starting point. One has to
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` then turn to purpose. The purpose of the claimed inventioning
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` in the Bunched-up Patent is to seal against an irregular
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` interface, an interface whose precise topography not only
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` varies from patient to patient, but even within a patient the
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` number, the location and size of what I call seep gaps is
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` unknown. Therefore, there is a technical reason that supports
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` my construction, which is more than just gathered together,
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` PIERS ACLAND QC
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` could vary, obviously that is schematic, so there could be
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` variations. Just explain a little bit more. What do you mean
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` by close folds? Do you mean by a minimum number or enough
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` folds that there are folds adjacent to each other without
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` gaps? What do you mean?
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`MR. ACLAND: What I mean is whether one look at the device, look
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` at the outer skirt, first of all, and identify folds. Those
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` folds do not have to be directly adjacent like little spikes
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` in cross-section.
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`JUDGE HACON: Okay, but they have to be close, so what does that
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` mean?
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`MR. ACLAND: The folds, rather than having a fold and then
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` but gathered together into close folds, because with close
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` folds one improves the prospects of sealing against an
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` unpredictable topography. That is the technical reason. That
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` supports -- it is entirely consistent with -- the natural
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` ordinary English language. That is the first point.
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`JUDGE HACON: Are you emphasising close folds or what?
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`MR. ACLAND: Yes, I am.
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`JUDGE HACON: Close?
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`MR. ACLAND: Yes, two things: one is folds and the other is close,
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` because of the inherent unpredictability of what you are
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` seeping into. If your little seep gaps are very close
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` together -- close folds -- you have a better chance of your
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` a length of fabric, then another fold, they run together.
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` Essentially, as one sees figure 23: they are a series of
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` continual folds.
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`JUDGE HACON: Right, so you mean between each fold there must be
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` an acute angle I think is what you mean, so there is no space,
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` there is no ----
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`MR. ACLAND: Yes, they are not displaced from one another.
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`JUDGE HACON: There is an acute angle between folds, so in that
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` sense one is closely located to the next.
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`MR. ACLAND: In that sense they are close, yes.
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`JUDGE HACON: I see. That is what you mean by close.
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`MR. ACLAND: It is what I mean.
`
`MARTEN WALSH CHERER LTD
`TEL: (020) 7067 2900
`
`1ST FLOOR, 6-9 QUALITY COURT, CHANCERY LANE
`E-MAIL: info@martenwalshcherer.com
`
`LONDON, WC2A 1HP
`FAX: (020) 7831 6864
`
`[2] (Pages 968 to 971)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1146, Page 2 of 82
`
`

`

`EDWARDS v BOSTON
`
`27 JANUARY 2017
`
`PROCEEDINGS DAY 7
`
`[Page 972]
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`[Page 974]
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` PIERS ACLAND QC
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`JUDGE HACON: I think I understand, and if they are not close,
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` they are outside the claim.
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`MR. ACLAND: Yes, my Lord -- circumferential folds, okay? So we
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` are now talking about the orientation of the folds.
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`JUDGE HACON: Yes. Is that in the claim?
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`MR. ACLAND: It is not in the claim, but I am going to submit to
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` you why it would be necessarily understood to be imported into
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` the claim. We see in figures 23 and 24 those horizontal folds
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` -- I will call them. They are the natural consequence of
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` foreshortening. What your Lordship is being asked to do is to
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` adopt one or two constructions, my construction and Boston's
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` PIERS ACLAND QC
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`MR. ACLAND: In other words, the fabric that forms the seal must
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` be found proximal to that distal end. That is how we read
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` that claim, not as Boston reads that claim, because Boston's
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` construction says this integer provides for the fabric seal to
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` extend from the distal end of the valve in the distal
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` direction and then in the proximal direction. In other words,
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` if you look at figure 22, what they say is what is allowed is
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` you can have a valve which is anywhere up inside the stent, so
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` if the valve is higher up in the stent than is shown in figure
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` 22, or indeed anywhere else in the specification, what this
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` language contemplates is that the fabric that forms the outer
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` construction. Boston's construction allows for vertical folds
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` because, on Boston's construction, it is silent, it is blind
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` to how those folds are configured. In other words, my Lord,
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` their construction embraces folds that actually create leak
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` paths.
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`JUDGE HACON: You mean their construction embraces exclusively
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` vertical folds.
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`MR. ACLAND: No, not at all, includes vertical folds.
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`JUDGE HACON: That is why I said embraces.
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`MR. ACLAND: Yes, I see -- embraces, absolutely right.
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`JUDGE HACON: "Includes", if you prefer. You say if their
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` construction includes vertical folds that would be
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` non-functional.
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` skirt can run distally round the bottom and then
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` proximally ----
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`JUDGE HACON: Presumably they say as long as it extends from the
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` distal end proximally over the anchor, whatever else it does
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` does not matter; is that what they say?
`
`MR. ACLAND: That just is not ----
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`JUDGE HACON: Is that what they say? Mr. Meade will explain.
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` I could conceive that as one possible construction.
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`MR. ACLAND: In effect, the reason my learned friend is construing
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` the claim in the way that he does, in other words, allowing
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` the fabric to extend distally first, is because he is trying
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` to catch the inner skirt in the S3 device. That is why he is
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` doing that. Does that make sense?
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`[Page 975]
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`[Page 973]
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` PIERS ACLAND QC
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`MR. ACLAND: Correct.
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`JUDGE HACON: So it cannot be right.
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`MR. ACLAND: That is a reason to reject their construction. It
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` creates a leak path. If it creates a leak path, it cannot be
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` sealed.
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`JUDGE HACON: You say on any view these folds must create a seal,
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` so they must take a form which allows for that function to be
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` performed.
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`MR. ACLAND: Correct. The next issue arises, going back to
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` claim 1, from the language -- do you see -- a fabric seal
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` extending from the distal end of the valve, proximally over
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` the anchor. Would you just read that to yourself again, my
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` PIERS ACLAND QC
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`JUDGE HACON: He is trying to catch the inner skirt.
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`MR. ACLAND: That is what he is trying to do.
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`JUDGE HACON: Why does he need to do that, because it has an outer
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` skirt?
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`MR. ACLAND: That is what he does, my Lord.
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`JUDGE HACON: All right. If the claim covers a valve with the
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` outer skirt, S3, that is enough.
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`MR. ACLAND: No, because it has to extend ----
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`JUDGE HACON: Why does he need to worry about the inner skirt?
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`MR. ACLAND: Plainly, it has to extend from the distal end of the
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` valve.
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`JUDGE HACON: Understood.
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` Lord, just as a matter of ordinary English as a starting
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` point? The valve has a distal end. The fabric must extend
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` from that distal end in the proximal direction. That is
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` how ----
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`JUDGE HACON: I am just making doubly sure I have it right. On
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` figures 22, 23 and 24, the distal end is ----
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`MR. ACLAND: It is the bottom end.
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`JUDGE HACON: The top is the proximal end.
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`MR. ACLAND: That is right. You can see in figure 22 the outer
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` fabric is extending from the distal end of the valve in the
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` proximal direction.
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`JUDGE HACON: Yes.
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`MR. ACLAND: That is why he relies on the inner skirt, because he
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` says the outer fabric has to extend to the valve.
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`JUDGE HACON: I see. Are you saying because it has to extend you
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` have to follow it from its origin to where it goes and that
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` includes going initially in the distal direction before it
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` goes in the proximal direction?
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`MR. ACLAND: Exactly. That is the fly in the ointment as far as
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` my learned friend's construction is concerned. That is why he
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` has to write in not just extending from the distal end in the
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` proximal direction, but extend distally and then proximally.
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`JUDGE HACON: The extension must be traced from origin to finish.
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` Part of that extension, you say, is extending distally;
`
`MARTEN WALSH CHERER LTD
`TEL: (020) 7067 2900
`
`1ST FLOOR, 6-9 QUALITY COURT, CHANCERY LANE
`E-MAIL: info@martenwalshcherer.com
`
`LONDON, WC2A 1HP
`FAX: (020) 7831 6864
`
`[3] (Pages 972 to 975)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1146, Page 3 of 82
`
`

`

`EDWARDS v BOSTON
`
`27 JANUARY 2017
`
`PROCEEDINGS DAY 7
`
`[Page 976]
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`[Page 978]
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` PIERS ACLAND QC
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` therefore, it falls outside the claim when we get to
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` infringement.
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`MR. ACLAND: Yes.
`
`JUDGE HACON: I see.
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`MR. ACLAND: That is a way of looking at it. There is actually an
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` easier way of looking at it, which is one looks at the
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` position, the distal end of the valve.
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`JUDGE HACON: I should not have put it in terms of infringement.
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` You say the extension must only go in one direction.
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`MR. ACLAND: Correct.
`
`JUDGE HACON: When you trace the extension from source to finish,
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` PIERS ACLAND QC
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` is bunched-up? Secondly, does the claim support
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` circumferential folds? Then, lastly, extending from the
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` distal end of the valve proximally.
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`JUDGE HACON: "Does the claim support circumferential folds"?
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`MR. ACLAND: Yes, I am sorry, I am talking about fabric folds of
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` the seal.
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`JUDGE HACON: Is that what you mean -- really? I thought you
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` meant does the claim support ----
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`MR. ACLAND: No, is it confined to circumferential folds.
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`JUDGE HACON: Okay. When you said does the claim support, what do
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` you mean? Is the claim limited to circumferential folds?
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` if it does not only go in the proximal direction ----
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`MR. ACLAND: You are out.
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`JUDGE HACON: You are out, I understand.
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`MR. ACLAND: Because you are only looking at what is on the
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` outside of the stent. You look at what is outside the stent,
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` and you say where does that start, where does that finish and
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` you have to have that material extending proximally from
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` the distal end of the valve.
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`JUDGE HACON: Throughout the extension, if I can put it that way.
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`MR. ACLAND: Throughout the exterior extension.
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`JUDGE HACON: You cannot have a beginning bit that goes in the
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` distal direction; is that right?
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`MR. ACLAND: Correct. We not only submit that my learned friend
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`MR. ACLAND: Yes.
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`JUDGE HACON: All right. What is five?
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`MR. ACLAND: That was 5. 4 was is it limited to circumferential
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` folds. 5 was extending from the distal end of the valve
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` proximally. In so far as the Sapien 3 device is concerned, we
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` have summarised in paragraph 194 how those issues of
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` construction give rise to non-infringement. I have just one
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` additional point to make in relation to the Sapien 3. My
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` clients have provided a PPD. They had proffered a witness,
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` Mr. Joseph, to be cross-examined on that PPD and in the end he
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` was not required for cross-examination. Nevertheless, what
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` you will see in Boston's closing submissions is that they
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` continue to rely upon the photographs of Dr Lutter's sample to
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`[Page 979]
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`[Page 977]
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` PIERS ACLAND QC
`
` is wrong on the natural meaning of the English, but also wrong
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` on purpose because the purpose of this bunching is to provide
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` an external seal, a seal against the irregular annulus,
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` outside the stent. Therefore, on his construction, in so far
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` as it allows material that comes up inside, what is that
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` material doing for the purposes of sealing that exterior
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` surface? It serves no sealing function.
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`JUDGE HACON: Do you mean the initial part of the extension?
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`MR. ACLAND: Correct.
`
`JUDGE HACON: The distal direction part of the extension serves no
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` sealing function.
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`MR. ACLAND: Correct.
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` PIERS ACLAND QC
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` establish infringement. The issue is whether the S3 -- Sapien
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` 3 -- as supplied by my clients infringes. We do not accept
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` the provenance of Dr Lutter's device. We think it has been
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` partly crimped, and certainly when Dr. Buller inspected it, it
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` had a reduced diameter of something more like 20 mm. We have
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` written to Boston's solicitors on the matter, but we have had
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` no reply. What I would be inviting your Lordship to do is to
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` -- and certainly as far as your judgment is concerned -- to
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` consider the device as it is described and depicted in the
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` PPD.
`
`JUDGE HACON: Okay.
`
`MR. ACLAND: Can I now do Cribier, first of all, and can you take
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`JUDGE HACON: It is only the proximal part, as it goes up the
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` outside, which can do that.
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`MR. ACLAND: As far as the language of the claim is concerned ----
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`JUDGE HACON: I understand, yes.
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`MR. ACLAND: To summarise, the issues that we think you have to
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` decide on construction are five-fold.
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`JUDGE HACON: Are they listed here?
`
`MR. ACLAND: They are in our skeleton, but I just wanted to make
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` it clear.
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`JUDGE HACON: By all means.
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`MR. ACLAND: First of all, twin-walled or double-walled; secondly,
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` disposed about the exterior. On the Bunched-up Patent, what
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` two bundles: bundles A3 and C1. What I am going to do -- and
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` this applies to both Cribier and also Bessler and Thornton,
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` and I can tell you that the detail and the evidence references
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` of what I am going to be suggesting to you are to be found in
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` our closing submissions -- is articulate the simplicity of the
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` case that arises as far as we are concerned on the three bits
`
` of prior art, the essential points. In so far as Cribier is
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` concerned, if you turn to internal page 11, at the top of the
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` page, the first three lines, "The invention will now be
`
` explained and another advantage and features will appear with
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` reference to the accompanying schematical drawings." Do you
`
` see that?
`
`MARTEN WALSH CHERER LTD
`TEL: (020) 7067 2900
`
`1ST FLOOR, 6-9 QUALITY COURT, CHANCERY LANE
`E-MAIL: info@martenwalshcherer.com
`
`LONDON, WC2A 1HP
`FAX: (020) 7831 6864
`
`[4] (Pages 976 to 979)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1146, Page 4 of 82
`
`

`

`EDWARDS v BOSTON
`
`27 JANUARY 2017
`
`PROCEEDINGS DAY 7
`
`[Page 980]
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`[Page 982]
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` PIERS ACLAND QC
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`JUDGE HACON: Yes.
`
`MR. ACLAND: We then turn to figure 6. I am sure your Lordship is
`
` now familiar with figure 6d: we have a valve leaflet, or
`
` rather a valve structure. We have a stent, the black line,
`
` and we have an outer cover together with an inner cover. Now,
`
` in bundle C1, if you "turn to Professor Fisher's first report,
`
` which is behind tab 4 and turn to paragraph 58, you will see
`
` what he is explaining, and let us just read it together:
`
` "After my initial review of the Cribier Patent" -- so
`
` this is the first document he saw in the case -- "before I had
`
` seen or reviewed the Patents, Powell Gilbert asked me to
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` PIERS ACLAND QC
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` your Lordship that the engineer when looking at figure 6d
`
` would implement the device so as to deliberately arrive at
`
` a taut external cover when the device was implanted.
`
` Not only does Cribier nowhere state that the external
`
` cover must be taut, but Boston's approach requires the skilled
`
` engineer to treat figure 6d as a design blueprint which it is
`
` plainly not. It is to use the language of the Cribier patent,
`
` one of a number of schematic drawings. So that is the first
`
` two points. There is much more to it than that because a taut
`
` external cover would also defeat the purpose which
`
` Professor Fisher identified, namely to enhance the
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` comment on the sealing means described in the Cribier Patent.
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` It was not surprised that the Cribier Patent proposed the
`
` abovementioned covers as a way of sealing to reduce leakage
`
` after implementation."
`
` Then can you read the whole of paragraph 59 to yourself?
`
` So you have taken 59 on board. You will recall
`
` Professor Fisher was cross-examined on this and it was
`
` suggested to him that Powell Gilbert had specifically asked
`
` him to look at figure 6d. He said absolutely not. The
`
` professor himself had drawn attention to figure 6d and the
`
` reason was because it had an external cover that he felt was
`
` important in the context of sealing. Can I give you that
`
` evidence reference? It is T5, page 821. Are you not writing
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` space-filling provided by an excess of material. So it
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` defeats the purpose. Yet further, my Lord, with a material
`
` such as Dacron, the engineer will have to find a way of
`
` overcoming the inevitable consequences of the changing
`
` geometry of the stent between its fully expanded and its
`
` deployed configuration. I think you heard that.
`
` Cribier, the patent, Cribier the man, used
`
` a balloon-expandable stent. When the balloon is deflated, the
`
` stent will recoil to some degree. In Cribier 2002, the
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` circulation paper, the reduction in diameter was about 8.5%.
`
` We have given the reference in our skeleton. With the recoil
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` obviously the circumference gets smaller. They will
`
` inevitably introduce some excess, but it is not just recoil
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`[Page 983]
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`[Page 981]
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` PIERS ACLAND QC
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` it down, my Lord.
`
`JUDGE HACON: It is on the transcript.
`
`MR. ACLAND: It is 821, line 16 to 822, line 24. Furthermore, the
`
` attractiveness of figure 6d had been apparent to the professor
`
` from the outset from his initial review of Cribier. That is
`
` T5, 827, lines 22 to 828, line 4. So he, like the skilled
`
` person, had focused on figure 6d because it offered attractive
`
` sealing solutions or an attractive sealing function. In his
`
` report then, if you turn on to paragraph 71 -- I am looking at
`
` 71 and 72 -- this follows. As far as the valvular tissue is
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` concerned, he considers that the engineer would use
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` pericardium, and as far as the external cover is concerned he
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` because the stent disclosed in the Cribier patent
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` foreshortens, as would the stent described in Cribier 2002,
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` although to a lesser extent. As the stent expands against the
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` lumen, it shortens in height.
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` Implications of foreshortening in relation to excess
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` material can be seen in Professor Fisher's first report,
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` paragraphs 67 and 68, so that is page 17. These diagrams are
`
` just illustrating a principle.
`
`JUDGE HACON: Yes, this is not in dispute, is it, that if you
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` foreshorten you will get some excess fabric?
`
`MR. ACLAND: If you take any of those cells in the top figure and
`
` imagine the fabric that is taut across that, when the device
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` would use PET (Dacron). The reason for using Dacron is the
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` reason he uses there and if you go back to paragraph 44 it is
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` because of the common-general-knowledge use of PET for other
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` applications in this field and he refers to vascular grafts.
`
` Do you see 44?
`
`JUDGE HACON: Yes.
`
`MR. ACLAND: And he said in cross-examination that he would have
`
` come to that view or rather the skilled person would have
`
` formed the same view as he did because the same combination of
`
` pericardium plus Dacron had been used in surgical heart
`
` valves. That is T5, 834, line 14 to 835, line 7.
`
` In order to get round Cribier, Boston has to convince
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` is crimped, the sides come together, the top goes out. And if
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` you read on to paragraph 80 of the professor's evidence:
`
` "... as can be seen by comparing the structures of figures 4
`
` and 5 above the intersection points of struts either move
`
` towards each other (in the horizontal direction) or away from
`
` each other ... It would therefore be logical to incorporate
`
` excess material in the expanded configuration to accommodate
`
` the increase in height ..." And then 81: "Incorporating such
`
` excess material would form circumferentially oriented folds of
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` material in the expanded configuration."
`
` As I say, in order for Boston to get round that
`
` evidence, they have to establish that what the professor
`
`MARTEN WALSH CHERER LTD
`TEL: (020) 7067 2900
`
`1ST FLOOR, 6-9 QUALITY COURT, CHANCERY LANE
`E-MAIL: info@martenwalshcherer.com
`
`LONDON, WC2A 1HP
`FAX: (020) 7831 6864
`
`[5] (Pages 980 to 983)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1146, Page 5 of 82
`
`

`

`EDWARDS v BOSTON
`
`27 JANUARY 2017
`
`PROCEEDINGS DAY 7
`
`[Page 984]
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`[Page 986]
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