UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`CONFORMIS, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`____________
`
`Record of Oral Hearing
`Held: April 18, 2018
`____________
`
`
`
`
`
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`
`
`Before PATRICK R. SCANLON, JAMES A. WORTH, and AMANDA
`F. WIEKER, Administrative Patent Judges.
`
`
`
`
`
`
`
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`
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`CONFORMIS, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`____________
`
`Record of Oral Hearing
`Held: April 18, 2018
`____________
`
`
`
`
`
`
`
`
`
`
`Before PATRICK R. SCANLON, JAMES A. WORTH, and AMANDA
`F. WIEKER, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`COLIN HEIDEMAN, ESQUIRE
`CHRISTY G. LEA, ESQUIRE
`NATHAN REEVES, ESQUIRE
`Knobbe Martens
`2040 Main Street
`Fourteenth Floor
`Irvine, California 92614
`
`ON BEHALF OF PATENT OWNER:
`
`
`SANYA SUKDUANG, ESQUIRE
`TIMOTHY P. McANULTY, ESQUIRE
`SYDNEY R. KESTLE, ESQUIRE
`KASSANDRA M. OFFICER, ESQUIRE
`Finnegan, Henderson, Farabow, Garrett& Dunner, LLP
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`
`
`The above-entitled matter came on for hearing on Wednesday,
`April 18, 2018, commencing at 10:00 a.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
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` 2
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`
`P R O C E E D I N G S
`JUDGE SCANLON: Good morning. This is a consolidated
`hearing for IPR2017-00544, IPR2017-00778, ’779 and ’780. The ’544
`proceeding pertains to patent number 7,534,263 and the ’778, ’779 and
`’780 proceedings all pertain to patent number 8,062,302.
`I'm Judge Scanlon in our Detroit office. And with me today on
`the panel are Judge Worth and Judge Wieker, who is participating
`remotely. I'll start with appearances. Who is here for petitioner, please?
`MR. HEIDEMAN: Good morning, Your Honors. Colin
`Heideman from Knobbe Martens on behalf of petitioner, Smith &
`Nephew. With me is Christy Lea and Nathan Reeves, also from Knobbe
`Martens. We also have Bill Clemmons from Smith & Nephew as well as
`an associate observing today.
`JUDGE SCANLON: Thank you. And for patent owner?
`MR. SUKDUANG: Good morning, Your Honor. Sanya
`Sukduang from Finnegan on behalf of patent owner, ConforMIS. I have
`with me my colleagues from Finnegan, Tim McAnulty, Kassandra
`Officer, Sydney Kestle and Dan Klodowski. And I have from
`ConforMIS Patricia Davis and Nick Stroeher.
`JUDGE SCANLON: Very good. Thank you. As set forth in
`the hearing order, each party will have 30 minutes to present arguments.
`Petitioner will present its case first and may reserve time for rebuttal.
`Patent owner will then present its case, and then petitioner may use any
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`reserved time for rebuttal. I ask each presenter to be sure to speak into
`the microphone. Otherwise, we may not be able to hear you clearly. I
`also ask each presenter to identify demonstratives referred to by slide
`number. We find that to be helpful to follow along. In the interest of
`keeping this hearing focused on the merits, I ask counsel not to interrupt
`the other side to make objections. Counsel may raise and discuss any
`objections during their allotted time.
`Counsel for petitioner, would you like to reserve any time for
`rebuttal today?
`MR. HEIDEMAN: We would like to reserve eight minutes,
`
`please.
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`ready.
`
`JUDGE SCANLON: Eight minutes?
`MR. HEIDEMAN: Yes, please.
`JUDGE SCANLON: In that case, please proceed when you are
`
`MR. HEIDEMAN: Your Honor, we do have a hard copy of the
`demonstratives. Could we pass those up?
`JUDGE SCANLON: Certainly.
`MR. HEIDEMAN: Good morning. I would like to start on
`slide 2. We have an overview of the grounds. And as the Board will see,
`the grounds here are virtually identical to those that the Board has seen
`previously in the IPRs for the '025 and '953 patents. The main disputed
`issue again is the combination of Radermacher and Alexander and
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`whether it would have been obvious to have a template that matches a
`cartilage surface.
`JUDGE WORTH: I'm sorry, could you speak a little louder.
`MR. HEIDEMAN: Sure. Now, because the Board has heard
`these issues a few times, I want to focus today's presentation on the new
`evidence that's of record in the IPR that was not of record in the '953 IPR
`for which the Board recently issued its final written decision.
`In particular, I want to focus on some additional admissions
`from ConforMIS' expert, Dr. Clark. For virtually every issue, Dr. Clark's
`admissions now support Smith & Nephew's positions, not ConforMIS',
`and so I want to highlight those. ConforMIS has argued in prior hearings
`as if Dr. Clark's cross-examination testimony does not exist.
`So I want to skip -- we have several slides in the beginning
`about Radermacher's disclosure. I want to skip over most of those
`because there are findings with respect to Radermacher in the '953
`written decision. And as the Board will see in our slides, we have those
`findings in yellow boxes at the top of the slides, and we have the
`evidence of record in this case that supports those findings here. It's all
`the same evidence, essentially, as was of record in the '953 proceeding.
`So I want to skip ahead to slide 15. Slide 15 has the first
`important admission from Dr. Clark in this proceeding. Again, this was
`not of record in the '953 IPR. You'll recall that Dr. Clark and
`ConforMIS' theory of Radermacher was that Radermacher discloses
`using recesses to avoid the cartilage surface and it matched bone only.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`On slide 15, we have Dr. Clark's admission from the deposition in this
`case, that's Exhibit 1219 is his deposition transcript from this case, and he
`was asked whether it would have been obvious -- let me back up. A
`person of ordinary skill in the art reading Radermacher in 1993 when it
`published would have known that they can make a template that matches
`cartilage, right? And his response was, “Yes.”
`So regardless of how the Board or ConforMIS construes
`Radermacher, ConforMIS' own expert has admitted that it would have
`been obvious in view of Radermacher alone to match the cartilage
`surface. This is consistent with Dr. Mabrey's opening declaration where
`he said Radermacher discloses matching the cartilage surface. And even
`if it didn't, it would have been obvious to a person of skill in the art in
`view of Radermacher alone.
`Now, of course the Board instituted these IPRs based on a
`combination of Radermacher and Alexander. The Board is familiar with
`Alexander. I'm not going to go through that again. The Board already
`found there was a motivation to match cartilage and combine the
`references. So I want to talk for a minute about obviousness under KSR
`on slide 19, because we have again more admissions from ConforMIS'
`expert that are highly relevant to this point.
`We know from KSR that where there's a finite number of
`options and all of those options were within the technical skill or grasp of
`a person of ordinary skill in the art, all of the options are obvious. And
`on slide 20, here in this case we have Radermacher who identified the
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`design need, the need for a patient-specific instrument that takes the
`intraoperative alignment work and shifts it to the preoperative planning
`phase so that you have an instrument that you can just set on the surface,
`make your cuts, and in the context of knee arthroplasty eliminates the
`need for the rod-based system.
`So Radermacher identified the need. There's no dispute that
`there's only two options here, a finite number of options, and that is to
`match the cartilage or the bone. And so under KSR, the only question,
`the only question is whether it was within the capability of a person of
`skill in the art to match cartilage. And again, on slide 21, this issue was
`resolved by ConforMIS' own expert.
`On slide 21 we have Dr. Clark's testimony where he admitted
`that a person of ordinary skill in the art who wanted to make a
`cartilage-matching total knee template could have done so in 2001 based
`on the images in Alexander. So under KSR, there's no dispute that there
`are only two options. Both of those options were within the skill of a
`person of ordinary skill in the art.
`JUDGE WORTH: Is this a reasonable-expectation-of-success-
`type argument? In other words, what you are arguing is that under KSR
`the reasonable expectation collapses into within the technical risk.
`MR. HEIDEMAN: Exactly, Your Honor. And I think this
`admission on slide 21 addresses both of those. It would have been
`known to a person of skill in the art and they could have done it. But we
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` 7
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`have more admissions on reasonable expectation of success, and I'm
`going to skip ahead to those now.
`JUDGE SCANLON: Quick question, counsel. So on your
`slide 21, one of patent owner's arguments is that Alexander does not
`relate to knee replacement. Is it your position that this admission refutes
`that argument?
`MR. HEIDEMAN: Certainly it does in part. There's a lot of
`evidence, a lot of admissions from Dr. Clark that support the idea that
`Alexander was highly relevant. The Board cited many of those in its '953
`final written decision. We'll get to a few more of those in minute, but
`you'll recall in the prior two hearings for the '953 and '025 we had a slide
`with a big box where Dr. Clark said unequivocally that he would have
`looked to Alexander if he was designing a patient-specific template as
`disclosed in Radermacher. So I don't think there's any really dispute that
`the Board has found in the '953 final written decision that Alexander was
`analogous art. I think that's well supported by the evidence cited in that
`decision.
`We had several other motivations to combine that I want to skip
`over because I think the Board has heard most of those before. On slide
`26 we have the analogous art findings from the '953. There's no reason
`that that finding would be any different here.
`So Judge Worth, to your point on reasonable expectation of
`success, starting on slide 27, when we filed the petition, the open
`question, to the extent there was any with respect to Radermacher, was
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`Radermacher disclosed taking your MRI, generating a 3D reconstruction
`and then generating a template that would match the natural surface. If
`there's any question, the only open question would have been was it
`within the skill of a person of ordinary skill in the art to generate a
`cartilage surface map so that they could then make a corresponding
`template.
`And Dr. Mabrey explained that in his opening declaration. A
`person of ordinary skill in the art had a reasonable expectation of success
`because it was known that MRI could determine the contour of the
`cartilage. And once you had the contour of the cartilage surface,
`everybody agrees you can make a matching template. And of course
`their patent confirms this. Their patent confirms that all you had to do is
`get a surface map as in Alexander and make a matching template. The
`ConforMIS patents rely solely on prior art imaging methods. They say
`that all the imaging methods were conventional and explained fully in the
`literature.
`On slide 28 we have more admissions from Dr. Clark from this
`proceeding. He was asked, “if someone came to you in 2001 and had the
`idea to match both bone and cartilage, you are saying they would have
`been reasonable in expecting that to work, right?”
`And he said, “I would want to see the rationale behind that idea,
`but it may very well be reasonable.”
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`And at the bottom of slide 28 we have another cite, another
`quote where he said, “I could see a reasonable person having that
`expectation,” meaning that a cartilage-matching template would work.
`On slide 29 we have another admission, and this one
`specifically with respect to Alexander.
`JUDGE WORTH: When you say admission, do you mean a
`party admission?
`MR. HEIDEMAN: Well, it's an admission by their expert. As
`a result of that, both experts agree and the evidence is undisputed that a
`person of skill in the art would have had a reasonable expectation of
`success. So whether ConforMIS' attorneys want to accept that or not,
`their arguments are not supported by the record. Both experts here agree
`that a person of skill in the art would have had a reasonable expectation
`of success.
`On slide 29, Dr. Clark was asked specifically about Alexander,
`and he responded the same way with respect to Alexander saying that a
`person of skill in the art and him specifically in 2001, if someone came to
`him and wanted to make a template that matches the surface shown on
`Figure 22B of Alexander, which is mostly cartilage and a little bit of
`exposed bone, he would have said that it could work.
`JUDGE WORTH: I'm sorry, which record are you in now?
`MR. HEIDEMAN: Pardon me?
`JUDGE WORTH: Which record are you in?
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`MR. HEIDEMAN: This is Exhibit 1219 is Dr. Clark's
`cross-exam testimony from this proceeding.
`JUDGE WORTH: Which proceeding?
`MR. HEIDEMAN: So we had a single deposition that covered
`both the '302 patent and '263 patents. So just as we consolidated this
`hearing today, we consolidated the experts' depositions and had a single
`deposition.
`JUDGE WORTH: You are saying it's in four -- it was entered
`in four --
`MR. HEIDEMAN: It's a single deposition transcript that was
`entered in all proceedings.
`JUDGE WORTH: Proceedings --
`JUDGE SCANLON: I believe Exhibit 1219 is the same in each
`of the four proceedings; is that correct?
`MR. HEIDEMAN: That's correct, Your Honor.
`JUDGE WORTH: Was this of record in the ’1874 case -- I'm
`using Board numbers here -- with the ’115 case or any of the other
`related proceedings in the family?
`MR. HEIDEMAN: So these specific admissions were from
`these proceedings. They would not have been of record for the '953
`patent, which was the final written decision that just issued last month.
`And it was not in the proceeding for the '025 patent which might be the
`one that you are referring to. So this is new deposition testimony from
`his latest cross-exam deposition in these four cases.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`JUDGE WORTH: Would you like to make the argument that
`applies? What is your position on that?
`MR. HEIDEMAN: It certainly applies. I think all of these
`admissions just confirm everything that we've presented at the prior
`hearings.
`JUDGE WORTH: Do you have any case law for the
`proposition that the record in one administrative proceeding can apply to
`another administrative proceeding?
`MR. HEIDEMAN: I don't have any off the top of my head. I
`would be happy to look at that and submit a paper on it. I think this was
`just really confirmation of what Dr. Mabrey had already said. He had
`already explained the reasonable expectation of success. It was
`ConforMIS who has really raised this issue at the last hearing on the '025
`patent. And this deposition was really cross-examining what their
`attorneys had represented to the Board in the '025 hearing.
`JUDGE WORTH: So he said that it may very well have been
`reasonable and it could have worked?
`MR. HEIDEMAN: Exactly, which is all obviousness requires.
`He was asked these questions repeatedly, and he never once said, no, a
`person of skill in the art would not have expected that to work. That
`never came out of his mouth. He repeatedly said, yes, it could work. I
`would want to see if it would work. I would say let's try it and see how it
`goes. That's classic obviousness, especially under KSR.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
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`
`So the only arguments that we've heard from ConforMIS as to
`why a person of skill in the art allegedly would not have been motivated
`to match cartilage or why they might not have had a reasonable
`expectation of success are the physical characteristics of the cartilage
`itself, and that is the fraying, compressibility, or degeneration problems
`that they have raised repeatedly in their briefs. As we talked about in the
`'025 hearing, there's nothing in the ConforMIS patents about these
`problems. It never suggests a problem. It never describes how they
`overcame the problem. And in fact, it presents bone and cartilage as
`equally viable alternatives. As we talked about in some detail in the '025
`hearing, the case law does not allow you to make this argument after the
`fact.
`
`But again, we have admissions from their expert confirming
`that these rationales are totally made up. So if we start on slide 31, this is
`the compression problem. You'll recall that Dr. Clark and ConforMIS
`argued that cartilage is more compressible than bone, so a person of skill
`in the art wouldn't have had a reasonable expectation of success. We
`talked in the prior hearing about how that compression would be
`microscopic and wouldn't impact the template. And Dr. Clark admitted
`that in his most recent deposition.
`The second bullet point on slide 31, Dr. Clark admitted that any
`compression would not prevent a person of skill in the art from matching
`cartilage. This idea is totally made up and has no support in the record
`from either expert.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`JUDGE WORTH: It seems like compressibility would possibly
`help your client in the sense that if cartilage is compressible, that could
`help a surgeon place a template and keep it in place to overcome any
`microscopic deficiencies in the matching.
`MR. HEIDEMAN: Could very well help, but their argument is
`that a person of skill in the art would not have been motivated to match
`because of this compression, because it's slightly more compressible than
`bone, which they don't have any support for.
`But Dr. Clark also admitted that if you have a template that
`matches bone and cartilage, which is what we are talking about here, the
`bone-matching portion would prevent any compression of the
`cartilage-matching portion, which is just common sense. So their
`cartilage compression problem is totally made up. No support for it
`anywhere in the record.
`JUDGE WORTH: When you say common sense, are you
`referencing something in the record?
`MR. HEIDEMAN: No. I think it's just common sense that if
`you have two portions of your template and some of it matches bone,
`some of it matches cartilage, and they are saying the cartilage portion is
`slightly more compressible, that bone is not compressible at all, but if
`you put that template on both, it can compress the cartilage because the
`bone-matching portion is hard and won't compress. So it won't move at
`all when you put it on there.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`JUDGE WIEKER: I assume that admission doesn't relate to the
`circumstance where you have a surface that's entirely covered by
`cartilage; is that correct?
`MR. HEIDEMAN: That's correct. The last bullet point would
`not apply to that situation. But that situation would be covered by the
`rest of his admissions which are -- that would never have prevented
`anyone from doing so. That argument is totally made up. There's no
`support anywhere in the record for that argument.
`On slide 32, cartilage degeneration --
`JUDGE WORTH: Can you address the notion that where there
`is compression that might actually not be matching, to the extent that a
`surgeon would be compressing, that that would be relying on something
`other than matching?
`MR. HEIDEMAN: There's no evidence that the cartilage
`would compress any meaningful amount. Neither of the doctors -- they
`both said they have never noticed cartilage compress when they do a
`knee surgery. This whole idea is made up. Both experts agreed that if
`you place the template on the cartilage, it will work just fine. That would
`not have prevented someone from making a cartilage-matching template.
`On slide 32, cartilage degeneration, they argued and want you
`to believe that cartilage would degenerate so quickly that between the
`time the imaging is done and a few weeks later when the surgery occurs
`that the template would no longer fit because the cartilage would
`degenerate so much that that template wouldn't fit.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`JUDGE WORTH: Is that the argument or is the argument that
`if there's something that is not a smooth surface already, you already
`have degeneration at the time that you have knee arthroplasty that is
`difficult to match and is not a smooth surface.
`MR. HEIDEMAN: I think that's a reference to the fraying
`argument, that the cartilage surface might not be smooth and might be
`hard to match. I have the next slide on that. But the degeneration
`argument is this idea that cartilage degenerates faster than bone, and it
`degenerates so fast that this template wouldn't fit at the time of surgery.
`Dr. Clark, in his deposition in this case, actually it was in the
`'953 case, admitted that he doesn't know how long it takes cartilage to
`degenerate. In this case he said, I don't know whether it would have
`prevented someone from making a cartilage-matching template.
`Dr. Mabrey, on the other hand, said that type of degeneration
`takes months, if not years to occur, so it couldn't possibly affect a
`template. And a person of skill in the art would not have considered that
`a problem in making a cartilage-matching template. Again, made up.
`Neither expert has testified in any way that supports that.
`So with respect to fraying, this is the picture they put in their
`brief, the little piece of cartilage that's shown floating in saline. Both
`experts agree that that type of fraying does not occur on the femoral
`condyles or the tibia, which is the part of the knee joint that we are
`talking about.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`JUDGE WORTH: I'm not sure that's what the fraying
`argument is. I think there was a distinction between two types of
`cartilage and that there was cartilage that was attached and detached. So
`my understanding of that is that if you have something that's not going to
`move with the bone and that you are not even talking about that in this
`context.
`MR. HEIDEMAN: So that is another issue they raised which I
`think is another red herring, which is delaminated cartilage, cartilage
`that's separated from the subchondral bone and is floating in the knee
`joint loose. No surgeon is going to try to match that cartilage. They are
`going to take an MRI of the knee, they are going to see that cartilage
`floating somewhere, and they are going to match the bone instead. That
`is a total sideshow, I think, as Christy mentioned at a prior hearing.
`The fraying argument is the one that they rely on most heavily
`and they provide that picture of the seaweed appearance, and they keep
`referring to that seaweed appearance and the crab meat appearance. That
`doesn't happen on this surface of the joint that we are talking about here.
`That happens on the backside of the patella, the kneecap. And as
`Dr. Mabrey explained, that occurs on the backside of the kneecap. It
`happens normally when the kneecap gets dislocated, it tears or frays the
`cartilage on the back.
`If you look at Dr. Clark's declaration, the article he cites,
`Exhibit 2009, is an article discussing fraying on the back of the patella.
`That's in knee arthroscopy where you inject saline into the knee and it
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`causes that frayed piece of the cartilage on the back of the patella to float.
`That's totally irrelevant to what we are talking about here, which is knee
`arthroplasty, knee replacement where there's no injection of saline. And
`both experts agree that any frayed cartilage, if there was any on the
`surfaces that we are talking about, would never appear in any imaging for
`the knee arthroplasty.
`JUDGE WORTH: I'm not sure I understand your argument.
`So let's put aside the saline because we are not talking about that in this
`context. Do you have testimony that there's no fraying or you can use
`synonyms for that on the surfaces that we are talking about?
`MR. HEIDEMAN: Absolutely. It's the first bullet point there
`has the admissions from Dr. Clark where he admitted that this typically
`occurs on the patella and the trochlea which is not the femoral condyle
`part of the articular surface that we are talking about. And in our reply at
`23 to 24 we have the cite to Dr. Mabrey where he explains that this
`virtually never occurs on the surfaces that we are talking about.
`JUDGE WORTH: So to honor the record you are referring to
`Exhibit 1219, page 39, lines 14 to 19; and page 35, line 25 to page 36,
`line 7; is that correct?
`MR. HEIDEMAN: That's correct. And we have in
`Dr. Mabrey's declaration, it's Exhibit 1202, paragraph 35 where he
`addresses this.
`JUDGE WORTH: Where is this in your brief?
`MR. HEIDEMAN: In the reply at 23 to 24.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`So I want to move ahead a little quickly. I know I'm running
`out of my opening time. The result of all of this is the Board's finding in
`the '953 final written decision with respect to Radermacher and
`Alexander should be the same here. All of ConforMIS' argument as are
`made up and lack support in the record.
`I want to skip ahead quickly to Woolson on slide 37. There's a
`couple aspects of Woolson that we've relied on here. The first is aligning
`the guides relative to the mechanical axis. There's no dispute that
`Woolson discloses that. There's no dispute that it was conventional. And
`on slide 38 there's no real dispute that a person of skill in the art would
`have been motivated to combine the teachings of the references.
`They do have an argument saying that it wouldn't have been
`obvious to combine or there would have been no motivation to combine
`because it would have been obvious in view of Radermacher alone to
`align those guides relative to the mechanical axis. But of course, if it was
`obvious in view of Radermacher alone, it was also obvious in view of
`Radermacher and a reference like Woolson that expressly teaches
`aligning relative to the mechanical axis and the importance of doing so.
`We also rely on Woolson for its disclosure, and I'm on slide 40,
`of the drilling holes and the cutting slots and the configuration really of
`the cutting guide. Woolson discloses that this is a conventional cutting
`guide. This is a conventional configuration. Both experts agree that the
`standard cutting guides in the 1990s had this configuration with two
`holes, multiple cutting slots.
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`Case IPR2017-00544 (Patent 7,534,263 B2)
`Case IPR2017-00778 (Patent 8,062,302 B2)
`Case IPR2017-00779 (Patent 8,062,302 B2)
`Case IPR2017-00780 (Patent 8,062,302 B2)
`
`
`For the most part, it's undisputed that Woolson discloses all of
`the additional limitations of the dependent claims in the '302 patent, just
`like it's undisputed that Hofmann and Biscup disclose the additional
`limitations.
`There's also no real dispute that a person of skill in the art
`would have been motivated to modify Radermacher's template to have
`that more common, classic geometry with two drilling holes and multiple
`cutting slots.
`The only disputed claims in this set are shown on slide 42
`where there's a dispute as to whether Woolson discloses cuts that have an
`angle of something other than 0 and 90 degrees. We have two cutting
`slots highlighted in red with an angle between them. The case law that
`we cited in our reply brief is very clear that you can rely on patent
`drawings when it's a nonspecific claim limitation and simple observation
`is all that's necessary to know what's disclosed. Both experts agree that
`that's the case here.
`Lastly, there are some articular surface claims in the '302
`patent. So we have been talking so far about cartilage surface, matching
`templates. There are some broader claims that just require matching the
`articular surface in general. And on slide 45 we have a listing of those
`claims. ConforMIS argued that they are patentable for substantially the
`same reasons as the cartilage surface claims. Clearly that can't be the
`case because they don't have that limitation.
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