Claim No HC-2015-004574
`
`IN THE HIGH COURT OF JUSTICE
`CHANCERY DIVISION
`PATENTS COURT
`
`BETWEEN:
`
`
`EDWARDS LIFESCIENCES LLC
`
`and
`
`BOSTON SCIENTIFIC SCIMED INC
`
`
`and
`
`(1) EDWARDS LIFESCIENCES CORPORATION
`
`Claimant
`
`Defendant
`
`Third Party
`
`
`(2) EDWARDS LIFESCIENCES SA
`(also known as EDWARDS LIFESCIENCES AG)
`Fourth Party
`
`
`(3) EDWARDS LIFESCIENCES LIMITED
`
`Seventh Party
`
`
`
`DEFENDANT’S CLOSING ARGUMENTS
`
`
`
`
`1
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 1 of 114
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`Overview ........................................................................................................................ 4
`Infringement ............................................................................................................... 4
`The inventions and the Edwards’ history ................................................................... 4
`The prior art ............................................................................................................... 6
`The patents ................................................................................................................. 7
`The witnesses ............................................................................................................. 7
`The skilled team and the way the case was put by Edwards in XX ........................... 8
`Introduction .................................................................................................................... 9
`Technical Background ................................................................................................. 11
`The Skilled Team ......................................................................................................... 13
`The Witnesses .............................................................................................................. 14
`Expert witnesses ....................................................................................................... 14
`Witness to Edwards’ Confidential Amended Product and Process Description ...... 18
`Edwards’ Civil Evidence Act Notice ....................................................................... 19
`Common General Knowledge (“CGK”) ...................................................................... 20
`CGK – the law ......................................................................................................... 20
`CGK – the Primer .................................................................................................... 21
`Issues arising as to the CGK .................................................................................... 24
`PVL as a problem for TAVI ................................................................................ 25
`Knowledge of surgical replacement valves ......................................................... 32
`Knowledge of Stents / Endografts ....................................................................... 33
`Foreshortening ......................................................................................................... 39
`Desirable characteristics for a THV ......................................................................... 39
`The Application ........................................................................................................... 40
`Risk of PVL ............................................................................................................. 41
`First method of sealing replacement valve against leakage ..................................... 42
`Second method of sealing replacement valve against leakage ................................ 43
`The ‘254 Patent ............................................................................................................ 45
`The ‘766 Patent ............................................................................................................ 47
`Construction ................................................................................................................. 49
`Construction: the law ............................................................................................... 49
`Construction: the Virgin point ................................................................................. 53
`Construction: the ‘254 Patent ................................................................................... 54
`The meaning of “bunched up” ............................................................................. 55
`Proximal / Distal .................................................................................................. 57
`“Flaps”, “pockets” and “pleats” of claims 2-5 ..................................................... 58
`Construction: the ‘766 Patent ................................................................................... 58
`The Key Claims ........................................................................................................... 62
`Infringement ................................................................................................................. 62
`Infringement of the ‘254 Patent ............................................................................... 63
`Non-infringement points taken in Edwards’ Skeleton ......................................... 67
`Infringement of the ‘766 Patent ............................................................................... 70
`Validity ........................................................................................................................ 71
`Bessler ...................................................................................................................... 71
`Cribier ...................................................................................................................... 73
`Thornton ................................................................................................................... 75
`Seguin ...................................................................................................................... 77
`Novelty ..................................................................................................................... 80
`Novelty: the law ................................................................................................... 80
`Novelty of ‘254 over Bessler ............................................................................... 81
`
`
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`2
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 2 of 114
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`Novelty of ‘254 over Cribier ................................................................................ 81
`Novelty of claims 1, 2, 6, 7 & 17 of ‘766 over Seguin ........................................ 83
`Novelty of ‘766 over Cribier ................................................................................ 83
`Novelty of ‘766 over Bessler ............................................................................... 84
`Obviousness ............................................................................................................. 84
`Obviousness: the law ........................................................................................... 84
`Obviousness of ‘254 over Bessler ........................................................................ 86
`Obviousness of ‘254 over Cribier ........................................................................ 90
`Obviousness of ‘254 over Thornton .................................................................... 95
`Obviousness of ‘766 over Bessler ...................................................................... 102
`Obviousness of ‘766 over Cribier ...................................................................... 103
`Obviousness of ‘766 over Thornton .................................................................. 103
`Obviousness of ‘766 over Seguin ...................................................................... 103
`Insufficiency .......................................................................................................... 105
`Insufficiency: the law ......................................................................................... 105
`Alleged insufficiency of ‘254 and ‘766 Patents ................................................. 105
`Added matter .......................................................................................................... 107
`Added matter: the law ........................................................................................ 107
`Allegation of added matter against ‘254 Patent ................................................. 111
`Intermediate Generalisation ............................................................................... 111
`Claim 6 of ‘254 Patent ....................................................................................... 113
`Allegation of added matter against ‘766 Patent ................................................. 114
`Conclusions ................................................................................................................ 114
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`3
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 3 of 114
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`Boston has incorporated closing submissions into its Skeleton Argument for Trial.
`Whilst there may be minor changes that have not been marked up, substantial additions
`to the text are indicated by the double sideline. References to “Edwards’ Skeleton” are to
`Edwards’ Skeleton Argument for Trial of 13/1/16.
`
`Overview
`Infringement
`
`1. On infringement, Edwards now advances only a couple of very weak and
`insubstantial construction points, the functional basis for which was not even
`put to Boston’s witnesses. It is entirely clear that the S3 uses the inventions of
`both of the patents.
`
`
`The inventions and the Edwards’ history
`
`2. It is also clear that the use of the inventions has provided a major advance.
`Addition of the outer sealing skirt cut down moderate/severe leakage to zero
`in the Edwards S3 (as compared with the XT), and Boston’s Lotus device
`(also with an outer sealing skirt) has the lowest leakage of all the many
`devices on the market. It is now known that even mild PVL is associated with
`higher mortality, but that knowledge came in 2013.
`
`3. At the priority date in 2003, there was a very different understanding, that
`modest PVL was quite acceptable and not incompatible with a good clinical
`result.
`
`4. Edwards and its predecessor in title PVT worked continuously in this field
`from pre-2003 right up until the present day, with the intimate assistance of Dr
`Cribier. So it knew all about the Cribier prior art (including figure 6d), but did
`not come up with the outer sealing skirt until the fifth generation of its
`product.
`
`
`
`
`4
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 4 of 114
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`5. Nor did any other company (except the patentee, of course): the various other
`companies have come up with the variety of quite different solutions seen at
`GL-23 figure 5, none of which is as good as the Lotus (or S3) in meeting PVL.
`
`6. In the period prior to Edwards coming up with the outer skirt, PVL had to be
`addressed in the Sapien products by the twin approaches of oversizing and
`redilation, but these were both appreciated to be unsatisfactory because they
`could lead to catastrophic annulus rupture among other complications
`(Schymik, GL-14).
`
`7. Edwards could have sought to explain properly why it did not come up with
`the outer sealing skirt idea: as the Court saw in the discussion in relation to the
`evidence of Mr Joseph, Boston clearly flagged well in advance that it was
`going to take the point (by Mr Burdon’s witness statement in July 2016, and in
`Lutter 1 and 2).
`
`8. An obvious person to explain why Edwards failed to come up with it would
`have been Dr Cribier, who is still active and apparently still involved with
`Edwards, and could speak to the whole time period. Instead Edwards
`prepared no evidence and made the extremely late application to bring
`evidence from Mr Joseph, without even putting forward a statement of what
`he would say. During the oral evidence it made various unfounded theoretical
`suggestions of why the skirt might not have been added; they were worthless
`and desperate.
`
`9. The fact that Edwards was in the field, working on the problem, well
`resourced, making other changes to its products to deal with PVL, aware of
`the cited prior art, and had the involvement of Dr Cribier, makes this a
`particularly powerful case of secondary evidence.
`
`
`
`
`5
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 5 of 114
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`The prior art
`
`10. That being said, Boston does not really need secondary evidence because the
`prior art is so weak.
`
`11. By this stage in a patent action, a party attacking validity, if it has a clear and
`focused case, is able to come down to one or at most two citations. But
`Edwards has failed to do this. It is still running four very different citations
`with very different approaches and is just unable to identify its best case.
`
`12. Thus Cribier is a complicated document with many ideas in it, but it would at
`least be seen by the skilled team to have some relation to reality. However,
`the skilled team would know that it was not taken in remotely the direction
`that Edwards say is obvious, and Edwards’ attack is a classic hindsight
`Technograph one (in which the individual steps are also hopeless in a number
`of instances).
`
`13. Bessler, by contrast, is not a real proposal and depends heavily on something
`(ablation of the native valve) which Edwards positively says was regarded as
`being unrealistic. It is also of a significantly different construction from
`Cribier, and is a self-expanding device and so contradictory to the Cribier
`approach, which depended on high radial forces. It is hard to see how Bessler
`can succeed if Cribier fails, and in Edwards’ evidence and opening skeleton it
`was very much an afterthought with just a couple of pages, referring back to
`Cribier. The attempt to breathe fresh life into it during the oral evidence is a
`result of Edwards losing confidence in Cribier.
`
`14. Thornton is from a completely different field altogether. It is an unclear
`exposition of a bad idea, and the attack involves taking one feature from it,
`inverting it, and using it in a completely different context. We remain unclear
`how Edwards will justify the combination of the Thornton flange with a TAVI
`device, but it is clearly abstract, artificial and ill-founded.
`
`
`
`
`6
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 6 of 114
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`15. Seguin comes from yet another direction and contains very numerous ideas,
`many of which are plainly lacking in sense. It is a matter of comment that it is
`maintained despite Dr Buller accepting straight way in XX (in striking
`contrast to his written evidence) that the embodiments he relied on are just not
`feasible.
`
`
`The patents
`
`16. It must not be overlooked that there are two patents and two inventions.
`Edwards seems to take the approach that as long as it can make a case that
`some excess material outside the stent was obvious, then it wins on both
`patents. This is simply not the case as the bunched up patent (‘254) requires
`that that material provide a seal and the sac (‘766) patent requires an outer sac,
`which fills with blood in response to backflow pressure, to provide a seal.
`
`17. Edwards’ XX simply did not even attempt to reach the sac patent, from any of
`the pieces of prior art.
`
`
`The witnesses
`
`18. We make some specific points about details of the witnesses and their
`demeanours and approaches below. The very clear high level distinction,
`however, is simply that Boston’s witnesses had relevant contemporary
`experience and Edwards’ did not. Prof Lutter was directly involved in TAVI
`in 2003 (and continually thereafter), whereas Dr Buller was not until 2007,
`when he embarked on 7+ years’ of work as an expert witness, never having
`any practical experience with patients or TAVI design. Prof Moore was
`closely involved with stent grafts; Prof Fisher did not have relevant
`experience.
`
`19. Edwards sought to set up evidence that its experts got to the inventions from
`the prior art before, and without knowing of, the Patents. This failed because
`Dr Buller knew all about the commercial embodiments and their features and
`
`
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`7
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 7 of 114
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`inferred that the case was about the S3, and for Prof Fisher it is unknown what
`products he was aware of prior to this case, he appears to have been directed
`to the issue of sealing figure 6d in Cribier by Powell Gilbert (or at least that
`cannot be excluded), and he explicitly says in his evidence that the later 5 or 6
`steps in his Technograph analysis from Cribier came after he saw the Patents
`(Fisher 1, paragraph 61).
`
`
`
`The skilled team and the way the case was put by Edwards in XX
`
`20. There was a discrete issue about whether stent grafts were the province of
`interventional cardiologists; Edwards’ case on that has rather collapsed with it
`becoming clear that Dr Buller himself never worked with those devices, at all.
`
`21. However, given the way that Edwards XX’d, a broader point has become
`important.
`
`22. It was and remains common ground that this is a case where the skilled person
`is a skilled team of a clinician and an engineer, and further that the clinician
`would take the lead in most respects, drawing on the engineer where
`necessary. See e.g. Buller 1 paragraph 32.
`
`23. Further, it was not Edwards’ case in its evidence or opening skeleton that
`either Patent was invalid as being obvious to just one member of the team (i.e.
`not a Schlumberger case).
`
`24. This all makes it quite extraordinary that Prof Lutter was not XX’d on the
`cited prior art on obviousness, at all. With the exception of a very cursory
`putting of anticipation by Seguin in the dying moments of his XX, he was not
`asked about the cited art at all. (Prof Moore was not asked about Seguin, but
`was asked about the other citations).
`
`
`
`
`8
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 8 of 114
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`25. Parties often argue that some point was not put in XX and this can be, and
`often is, overdone, e.g. where the point is a minor one or where it has been
`challenged in substance but not in the precise words used by the witness.
`
`26. That is not this case, however. Prof Lutter was just not challenged in his
`evidence on the prior art citations. His evidence on that must be accepted and
`Edwards is not now allowed to advance a case that was not put to him.
`Edwards’ approach is particularly surprising since its opening skeleton
`identified a large number of points of Prof Lutter’s evidence which it said
`were in dispute, and in some instances specifically said would be explored in
`XX (see e.g. paragraph 242 on Bessler).
`
`27. We await Edwards’ explanation of this approach. There are two excuses
`which clearly will not do: it is no answer that Prof Moore was asked, since he
`gives only the engineer’s perspective, and it is no answer that time for XX ran
`short with Prof Lutter.
`
`Introduction
`
`
`28. This action concerns repositionable heart valves for transcathether heart valve
`(or “THV”) replacement procedures that have been designed to prevent the
`problem of paravalvular leakage or “PVL”.
`
`29. Edwards commenced these proceedings originally seeking revocation of one,
`then two, of Boston’s patents: European Patent (UK) 2,749,254 (the ‘254
`Patent) and European Patent (UK) 2,926,766 (the ‘766 Patent). Both Patents
`derive from PCT/US2004/043607 (the “Application”). They are both entitled
`“Repositionable heart valve” and the earliest priority date of both is 23rd
`December 2003 (the “Priority Date”). They are 2 of 15 European patents or
`applications within the same family.
`
`
`
`
`
`9
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 9 of 114
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`30. Both Patents are currently subjects of opposition proceedings at the EPO1.
`Edwards is one of the opponents against both.
`
`31. Boston has counterclaimed that Edwards’ product – the S3 valve – falls within
`the claims of both of the Patents. A Part 20 claim has also been brought
`against other members of the Edwards group. To the extent that there remain
`outstanding issues as to which Edwards’ company is responsible for which
`acts, the parties have agreed to stay those matters until resolution of the
`technical issues2.
`
`32. Thus although Edwards started the proceedings, in substance they are now a
`claim for infringement with invalidity as a defence, and accordingly the issues
`that this Court has to decide are:
`
`
`
`
`
`
`
`(1) Does the S3 valve infringe?
`
`(2) Is the ‘254 Patent valid in light of Edwards’ attacks based on:
`(i)
`Bessler (novelty and obviousness);
`(ii)
`Cribier (novelty and obviousness);
`(iii)
`Thornton (obviousness only);
`(iv)
`Insufficiency: this is advanced by way of squeeze with obviousness
`case;
`Added matter;
`
`(3) Is the ‘766 Patent valid in light of Edwards’ attacks based on:
`(i)
`Bessler (novelty and obviousness);
`(ii)
`Cribier (novelty and obviousness);
`(iii)
`Sequin (novelty of certain claims and obviousness);
`(iv)
`Thornton (obviousness only);
`(v)
`Insufficiency: again, advanced by way of squeeze;
`(vi) Added matter.
`
`(v)
`
`
`
`1 The ‘254 Opposition commenced in September 2015, the ‘766 Opposition commenced in
`June 2016
`2 Consent Order dated 6/10/06 at § 1 B/26
`
`
`
`10
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 10 of 114
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`Technical Background
`
`
`33. The Patents are concerned with heart valves for use in THV replacement
`procedures. Replacement of the aortic valve of the heart by a THV is
`commonly known as “TAVI” – “transcatheter aortic valve implantation”. At
`the Priority Date, TAVI was a largely experimental procedure at an early stage
`of its development. Dr Cribier, one of the leaders in the TAVI field, had
`carried out his first TAVI procedure3 on a human patient only just over 18
`months before the Priority Date. As at the Priority Date, only a handful more
`such procedures had been carried out, all by Dr Cribier. The technique was
`considered to be one of ‘last resort’, used only on the most poorly patients, in
`compassionate circumstances, who would be unable to survive the trauma of
`open-heart surgery. TAVI devices were not approved for use until 2007, some
`four years after the Priority Date. Until very recently, TAVI devices were only
`approved in most countries (including Europe) as an exceptional measure
`where the patient was thought to be at high risk in relation to open-heart
`surgery.
`
`34. Against this background, the inventions disclosed in the Patents are forward
`thinking. The Patents recognise that a potential problem of TAVI devices is
`PVL, namely leakage which can occur both through the frame of the device as
`well as around its edges i.e. in the gaps between the sides of the TAVI device
`and the irregular, calcified native leaflets against which it was positioned
`when deployed.
`
`
`
`35. The Patents then teach two broad types of seal which serve to prevent PVL.
`The ‘254 Patent is concerned with a seal formed of bunched up fabric that is
`designed to fill in the gaps between the exterior of the TAVI device and the
`irregular calcified leaflets against which it is positioned in use. The ‘766
`Patent is concerned with a seal that comprises at least one fabric sac disposed
`externally around the TAVI device which is designed to fill with blood and
`which provides a seal between the exterior of the TAVI device and the
`
`
`
`3 A cardiologist, Dr Philip Bonhoeffer, had previously implanted a small number of
`transcatheter pulmonary valves (in 7 children and 1 adult) – Luttter 1 at §49
`
`
`
`11
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 11 of 114
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`irregular calcified leaflets. Both of these seals were originally disclosed in the
`Application.
`
`36. The teaching of the Patents was truly innovative. No such seal was present on
`early embodiments of TAVI devices. Indeed, Edwards’ own TAVI product
`has gone through a number of development stages. Its first incarnation was as
`the device that Cribier himself used, a device that was manufactured by
`Percutaneous Valve Technologies (“PVT”)4. That original technology was
`developed via the “Sapien”5 and the “Sapien XT”6. However, it was not until
`20147 that Edwards launched the S3 which, for the first time, incorporated an
`outer skirt which was specifically designed “to minimize paravalvular leak”8
`in a way which uses the inventions of the patents in suit:
`
`
`
`
`
`
`
`
`
`
`
`4 Edwards purchased PVT shortly after the Priority Date
`5 Available between 2005 and 2009
`6 Introduced in 2009: the Sapien XT had a new nitinol strut frame design, increased radial
`force, a larger inner skirt and a change to the leaflet design (Lutter 1, §155)
`7 Lutter 1, §§155-157
`8 e.g. Annex 6 Particulars of Infringement B/12
`
`
`
`12
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 12 of 114
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`37. The following photograph9 illustrates the difference between the Sapien (left)
`and the S3 (right) and, in particular, shows the outer skirt of the S3 which
`comprises excess fabric that is only attached at certain points, so as to form a
`number of sacs on the outside of the frame:
`
`
`
`
`
`
`38. Thus Edwards has stated that its devices accomplish that which the patents in
`suit teach (minimising PVL by bunching and sacs), and it is clearly to be
`inferred that it regarded the benefit as worth making a significant change to its
`products. It is also plainly inconsistent with Edwards’ obviousness case that it
`did not introduce this feature until so long after the priority date. Edwards has
`led no evidence to address these matters.
`
`The Skilled Team
`
`
`39. The parties are agreed that the Patents are addressed to a skilled team
`comprising an engineer and a clinician. There is, however, disagreement as to
`whether the clinician would be an interventional cardiologist, a radiologist or a
`cardiac surgeon with an interest in TAVI 10 or would simply be an
`interventional cardiologist11. Boston contends that the Skilled Clinician could
`be any of the three, provided he/she had an interest in TAVI. Edwards
`
`
`
`9 Fig. 6 Lutter 1 at §158
`10 Lutter 1, §88 & Moore 1, §§32 & 36
`11 Buller 2, §§6-7
`
`
`
`13
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 13 of 114
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`contends that only the interventional cardiologist would be interested in the
`teaching of the Patent.
`
`40. Following XX this dispute is of marginal, if any, relevance. It was clear from
`the XX of Prof Lutter that cardiologists and cardiac surgeons work closely
`together in treating patient with heart problems12. Furthermore, whereas an
`interventional cardiologist specialises in using percutaneous catheter-based
`treatments for the hart, he does not usually have experience of the great
`vessels (e.g. treatment of AAAs or TAAs): despite his written evidence to the
`contrary, Dr Buller did not have such experience13. In XX, his evidence was
`that this work would be done by interventional radiologists14 and ascribed his
`interest in endografts to his surgical colleagues15. Prof Lutter’s evidence was
`that interventional cardiologists, interventional radiologists and cardiac
`surgeons all practiced with catheters and wires. It is clear that there is an
`overlap between these specialities; TAVI was an alternative to surgery which
`both cardiologists and surgeons were interested in16. There is therefore no
`reason to exclude the Skilled Cardiac Surgeon from the Skilled Team.
`
`
`The Witnesses
`
`Expert witnesses
`
`
`41. Reflecting the fact that these are Patents directed at a Skilled Team, both
`parties are relying upon the expert evidence of a clinician and an engineer.
`
`42. Boston’s clinical expert witness is Prof Lutter, a cardiac surgeon. Prof Lutter
`has been the Professor of Cardiac Surgery and Head of Department of the
`Experimental Cardiac Surgery and Heart Valve Replacement Department at
`
`
`
`12 T3/p363/24 – p365/14
`13 T4/p646/16-24
`14 T4/p647/22-23
`15 T4/p648/4-13
`16 See e.g. the debate over whether ablation techniques were generally preferred by surgeons -
`T4/p582/4 – p586/24
`
`
`
`14
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 14 of 114
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`the University of Kiel, Germany, since 2008/0917. Prof Lutter’s expert reports
`are at D1/1, D1/9 and D1/11. Prof Lutter has had a general interest in
`transcatheter and minimally invasive, cardiac surgical and cardiological
`procedures throughout his career. He implanted and conducted tests on one of
`the first transcathether aortic devices in animals back in 1997 and, more
`recently, has been interested in the development of transcatheter devices for
`use in replacing or repairing the mitral valve18. He routinely carries out
`transcatheter aortic valve implantation (“TAVI”) procedures at the University
`of Kiel and regularly implants the S3: he estimates that he has carried out
`around 250 implantations of the S3 in the last two years (2015 & 2016)19. He
`has taught physicians to implant both the S3 and its predecessor, the Sapien
`XT20.
`
`
`
`43. Prof Lutter was a very fair witness who did his best to assist the court. Given
`his experience of working on TAVI devices at the Priority Date, he was
`excellently placed to assist the Court as to the thinking of the Skilled Clinician
`at the Priority date. His first-hand experience of implanting TAVI devices21,
`including the S3, also put him in a very good position to advise on the various
`infringement issues. Large parts of Prof Lutter’s evidence were not challenged
`at all (e.g. apart from a cursory challenge on Seguin, he was not challenged on
`any of the prior art). An attempt to sideline him on the basis that his
`experimental TAVI work on pigs involved placement just below or above the
`annulus22, was entirely unconvincing. Similarly, the attempt to sideline him on
`the basis of his interest in ablation of native leaflets fell flat: not least because
`two of the pieces of prior art relied upon by Edwards teach ablation of the
`native leaflets23.
`
`
`
`
`
`44. Boston’s engineering expert witness is Prof Moore. Prof Moore is the
`Professor of Biomedical Engineering at Imperial College, London. His expert
`
`17 Lutter 1, §§1-4
`18 Lutter 1, §§5-6
`19 Lutter 1, §8
`20 Lutter 1, §9
`21 T3/p406/4-p408/11
`22 T3/p433/7-21
`23 T3/p414/24-p436/11 & T4/p475/24-25
`
`
`
`15
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`Edwards Lifesciences Corporation, et al. Exhibit 1145, Page 15 of 114
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`reports are at D1/4, D1/10 and D1/12. Prof Moore is a mechanical engineer
`by background, but has had a general interest in transcatheter and minimally
`invasive cardiovascular procedures throughout his career. Between 2001 and
`2003, he held the position of Director of the Cardiovascular Engineering
`Centre at the Florida International University. He has worked extensively in
`the field of stents, advised numerous biomedical device companies and
`regularly presents conferences around the world as well as teaching
`cardiovascular biomechanics and
`the effects of stenting
`to Masters
`Engineering students24.
`
`45. Prof Moore was a very fair witness who patiently gave his evidence over two
`days. He gave careful answers to the questions he was asked and did his best
`to assist the court on the matters of biomedical engineering that arose. He was
`in an excellent position to assist the court given his breadth of experience in
`designing and developing stents: in particular, he was very knowledgeable and
`experienced in the area of endografts, one of the areas on which Edwards
`placed particular focus. During XX on one piece of prior art (Thornton), he
`dealt with assumption upon assumption, but gave sensible responses which
`reflected the views of the Skilled Engineer who, at the Priority Date (as at any
`other time) was simply interested in whether the teaching would work: if it did
`not, no number of assumptions would make it worthwhile trying25.
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`46. Edwards’ clinical expert witness is Dr Buller, a retired consultant c