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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
`
`
`SMITH & NEPHEW, INC.,
`Petitioners,
`
`v.
`
`CONFORMIS, INC,
`Patent Owner.
`_____________
`
`Case IPR2017-00115
`Patent 9,216,025 B2
`____________
`
`Record of Oral Hearing
`Held: January 8, 2018
`____________
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`
`
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`
`
`Before BEVERLY M. BUNTING, JAMES A. WORTH, and AMANDA
`F. WIEKER, Administrative Patent Judges.
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`Case IPR2017-00115
`Patent 9,216,025 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`JOSEPH R. RE, ESQUIRE
`Knobbe Martens
`2040 Main Street
`14th floor
`Irvine, CA 92614
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`SANYA SUKDUANG, ESQUIRE
`Finnegan, Henderson, Farrabow, Garrett & Dunner, LLP
`901 New York Avenue, N.W.
`Washington, D.C. 20001
`
`
`
`
`
`The above-entitled matter came on for hearing on Monday,
`January 8, 2018, at 10 a.m., at the U.S. Patent and Trademark Office,
`Madison Building East, 600 Delany Street, Alexandria, Virginia, before
`Walter Murphy, Notary Public.
`
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`Case IPR2017-00115
`Patent 9,216,025 B2
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`P R O C E E D I N G S
`- - - - -
`JUDGE WORTH: Please be seated. Judge Bunting, can you hear
`us? We can’t hear you --
`JUDGE BUNTING: Can you hear me now?
`JUDGE WORTH: Yes.
`JUDGE BUNTING: I think I was muted. Okay, thank you.
`JUDGE WORTH: Okay. We’re ready to begin. This is an oral
`hearing in PTAB case No. IPR2017-00115 between Petitioner Smith &
`Nephew, Inc., and Owner of U.S. Patent 9,216,025 B2, ConforMIS, LLC.
`My name is Judge Worth, on my right is Judge Wieker and participating
`from the Midwest Regional Office is Judge Bunting.
`As you know, per our Order each side has 30 minutes to present
`their arguments. Because Petitioner has the burden to show
`unpatentability of the original claims, Petitioner will proceed first
`followed by Patent Owner. Petitioner may reserve rebuttal time, but may
`only use this time to rebut Patent Owner’s arguments.
`A brief comment regarding any objections. Each party may state
`objections, for example, to demonstratives, during it’s allotted time and
`we will take the objections under advisement for the final written
`decision. That being said, counsel are asked to refrain from using any
`demonstratives that introduce material not already submitted in briefing
`or exhibits that are of record. When rendering our final written decision,
`we will disregard any new evidence or argument. In the hopes of
`keeping this hearing focused on the merits, we ask that counsel not
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`interrupt the other side to make objections. Any objections may be
`discussed during the party’s time at the podium.
`Petitioner, would you like to reserve time?
`MR. RE: I would, Your Honor, at least five minutes for rebuttal.
`JUDGE WORTH: I’d like to ask the parties to introduce
`themselves, starting with Petitioner please.
`MR. RE: Good morning, Judge Worth. Good morning, Judge
`Wieker and Judge Bunting. My name is Joseph Re from the law firm of -
`-
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`JUDGE BUNTING: Excuse me. I’d like to remind everyone to
`step up to the podium because I can’t hear you if you’re not standing at
`the podium.
`MR. RE: How about now? Is this good?
`JUDGE BUNTING: Now I can hear you. Thank you.
`MR. RE: Okay. My name is Joseph Re and with me are my
`partners Colin Heideman to my right, and Christy Lea, and for the client
`is Bill Clemmons and with him is his colleague Brad Lennie.
`MR. SUKDUANG: Good morning, Your Honors. Sanya
`Sukduang from Finnegan, Henderson on behalf of ConforMIS. I have
`with me my colleagues, Tim McAnulty, Sydney Kestle, Kassandra
`Officer, Dan Klodowski and from ConforMIS Dave Cerveny.
`JUDGE WORTH: One moment, please. I would like to remind
`counsel that because Judge Bunting is participating by teleconference,
`please keep in mind that she may not be able to see, for example, what is
`on the screen and so it’s helpful for the record and for Judge Bunting to
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`call out the demonstrative number. Petitioner, you may begin when
`ready.
`MR. RE: Thank you, Your Honor. This oral argument is going to
`sound very, very familiar to you because we were all here on December
`8, and we are basically discussing the identical issues because Patent
`Owner is relying upon the same characteristic for patentability as they
`did back on December 8 when we were before you and Judge Scanlon.
`And so, time permitting, I want to say I want to discuss the patent
`and we’re talking about the disclosure or understanding that the template
`in knee replacement surgery could rest against the cartilage as opposed to
`the bone. That seems to be the magic that the Patent Owner believes they
`invented and that is having an inner surface which matches or
`substantially matches -- these claims are a little broader than the ’953
`patent you had last month -- against the cartilage as opposed to the bone.
`Then we’ll discuss the motivation to combine the references and lastly,
`the other limitations are really not at issue. Patent Owner is not relying
`upon the mechanical axis which is shown in Woolson or that it’s used
`with implants which is shown in Biscup, so those are undisputed and
`really we don’t need to spend time on those additional bells and whistles.
`This picture should look familiar to you. I’m sure you’ve been
`looking at it quite a bit, but you’ll notice that the ’025 patent on the left is
`virtually the identical pictures and disclosure with regard to this aspect of
`the invention from the ’953 --
`JUDGE BUNTING: Counsel, excuse me. What slide are you
`looking at?
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`MR. RE: This is slide 3, I apologize. Slide 3 just shows the
`pictures --
`JUDGE BUNTING: Please announce the slide numbers.
`MR. RE: I will. I apologize.
`JUDGE BUNTING: Thank you.
`MR. RE: Okay. And so they were called guides in the ’025. They
`were called slits in the ’953. But we’re basically talking about the same
`template, and the disclosure in these patents is critical to really determine
`how these experts -- we have conflicting experts on some points -- and
`you are tasked with judging the credibility of these declarants, and what I
`ask is how you can really determine on this record who is using hindsight
`and who isn’t.
`Most of the time your answer will be revealed by the specification,
`and here on slide 4, I am showing what does the specification say about
`the so-called invention about aligning and using the inner surface of the
`cartilage rather than the bone. And I have before you -- and this is true
`throughout the spec – the spec gives no significance whatsoever whether
`you’re matching the bone or the cartilage. It identifies no problem with
`cartilage. It shows no magic. There’s no preparation to the cartilage.
`The invention is simply either. They are simply claiming all of the
`available alternatives and there’s only two alternatives, cartilage or bone,
`and the spec shows they invented nothing with regard to either.
`And so all this information about the undesirable characteristics of
`cartilage, it’s not borne out in the spec. The spec, written in 2001
`obviously before they had Radermacher, they make no distinction
`between cartilage or bone, and that’s just what my expert says. Dr.
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`Mabrey says this was never a problem. Cartilage is so thin, and if you
`look at the pictures in Alexander, it’s so thin that it does not in any way
`interfere with putting on a template for purposes of sawing and cutting
`and drilling the end of a femur.
`So here’s the next surprising aspect, and I can’t wait to hear Patent
`Owner explain some of these questions that I have. Here are the two sets
`of claims. This is slide 5. Slide 5 shows the first set of claims which all
`their briefing is on, are claims 1 to 14. There’s no briefing. There’s no --
`I should say there’s no evidence or real argument on claims 15 to 20 -- 15
`to 20 are broader because they claim articular surface and you remember
`from your claim construction, which both parties have embraced and it is
`correct. But articular surface means the surface of the articulating bone
`that includes either cartilage or bone. Now you remember in the ’953,
`they --
`JUDGE BUNTING: Counsel, sorry to interrupt you.
`MR. RE: Yes.
`JUDGE BUNTING: Because you just – it sounds like you’re
`talking about two options, cartilage or bone. But looking at our claim
`construction I see the “or” in there, so could you have cartilage and bone,
`or cartilage only, or bone only?
`MR. RE: Yes.
`JUDGE BUNTING: There’s three different options?
`MR. RE: Yes. If you want to treat -- yes, it’s whatever is there,
`cartilage, bone or any combination thereof, that is correct. That is
`absolutely correct. And so obviously claims 15 to 20 include bone only.
`Now in the ’953 case they disclaimed all the claims that were to articular
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`joint surface, you might recall that, and we had a discussion about the
`need for adverse judgment, you might remember that, and Judge Worth
`you asked some questions about why adverse judgment matters and
`whether or not the Board should do adverse judgment.
`Well this case is a good example, and there’s many cases like this
`where ConforMIS is still trying to get claims to articular surface, even
`though articular surface could be bone only or cartilage only, or any
`combination thereof as Judge Bunting pointed out, and their expert was
`told to opine on claims 1 to 14 only. But what’s so incredible about this
`case is that ConforMIS cannot even keep the surfaces straight and they
`argue to you at least three or four times in their brief that claims 15 to 20
`should be allowed or not cancelled for the same reasons as claims 1 to 14
`and they say that on page 1, page 33, pages 78, 79, and when they argue
`those claims they point to cartilage surface. So even ConforMIS, in their
`own brief, cannot keep straight the fact that there’s a major distinction in
`their own case between cartilage and articular surface and this is why
`adverse judgment matters because they are trying to get articular surface
`claims regardless of the -- and there’s lots of patents pending but they
`keep getting rejected on articular surface -- but here they are, here’s a
`subsequent patent to the ’953 and they’re going for articular surface.
`Let’s take a closer look at the claims now. This is just like the
`’953, cartilage surface. It’s a little broader, and I’ve italicized the
`language that differentiates it from the ’953.
`JUDGE WORTH: We’re on slide 6.
`MR. RE: Slide 6, thank you, Judge Worth. Slide 6. This is just
`like the ’953. This is the cartilage surface claims 1 through 14 and we’ll
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`be discussing claim 1. And here is claim 15, 15 to 20 is articular surface
`and they’re not relying on the two drilling holes for patentability. So
`their expert said nothing about these claims. These claims should have
`been disclaimed and I don’t know why they weren’t disclaimed.
`So now let’s get down to the grounds. The Board took all the
`references and instituted, looking at the references collectively, this is
`slide 8, and we’re only debating the red. That is Radermacher in
`combination with Alexander or Fell, which Alexander and Fell are
`explicit about the cartilage, and so most of this debate we’re having is
`about Radermacher. You must be tired of hearing about Radermacher.
`But Radermacher is a -- I’ve had another case, it’s a well known
`reference. Here’s the debate between the parties. They read
`Radermacher, and this was their slide from the last hearing and this is
`their slide from this hearing. The red is mine on slide 10.
`Slide 10. The only disagreement we really have about
`Radermacher is they believe Radermacher’s embodiments are bone only.
`They read in the word only throughout their briefing. I think that’s an
`over-reading of Radermacher. Radermacher talks about bones generally
`because Radermacher’s entire disclosure is using templates throughout
`the human body. It’s a general description, and so he uses No. 17
`throughout to point to the osseous structure or the bone. I don’t think
`osseous structure or bone and how it’s defined gets us anywhere, because
`that’s a general description and they take us to task for always relying
`upon a sentence that’s specific.
`There’s only one sentence in Radermacher that’s specific to the
`characteristics of the surface itself, and this is slide 11. This is the
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`language that we rely upon that they really have no answer for and
`what’s great about this sentence is that it caused the parties to join. This
`is a specific disclosure about the characteristics of the surface and the
`surface is the natural not pretreated surface of the osseous structure
`intraoperatively accessed by the surgeon, and this language -- remember
`they gave us a hard time about relying so heavily on this sentence -- well
`their expert agrees this is one of the goals of Radermacher is to have no
`pretreatment and no pretreatment means the cartilage remains. That’s
`why we believe Radermacher does at least suggest cartilage remaining
`and when you put on the template.
`JUDGE WORTH: Dr. Clark might not dispute that but
`understands the template to interface with the bone that’s exposed.
`MR. RE: Bone only. Yes, that is correct. He believes it somehow
`avoids the cartilage, so he created an option where it avoids the cartilage
`and contacts the bone only. Only, that’s key. Hey, we’re of the view if it
`contacts the bone, great, but it’s going to contact the cartilage as well.
`That’s where we differ.
`So let’s delve a little closer into Radermacher and here are the
`pictures of Radermacher, and I’m sure you’ve seen these. This is slide
`12, and slide 12 shows Radermacher on a femur. Clearly we all agree
`that’s a cohesive region, this is the femur upside down rotated, and the
`patient specific surface is whatever’s there, the natural not pretreated
`surface in our view and guess what? We’re both in agreement that the
`cartilage is present and imaged in Radermacher. This we didn’t know at
`the time of our petition. We didn’t know that they would agree that
`cartilage is present and imaged in Radermacher and there are the citations
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`where both experts agree that the vast majority of knee replacement
`patients have some articular cartilage. You can’t avoid the fact that the
`vast majority of patients have cartilage when they get a new knee and
`they agree, and it’s undisputed, that Radermacher uses MRI and the MRI
`would have imaged the cartilage. That’s another concession we didn’t
`know they would make at the time we filed our petition.
`So when we filed our petition, this is slide 14 Judge Bunting. Slide
`14 we just put together what we thought were the two options and Judge
`Bunting is correct. The first option is match the cartilage and any
`exposed bone. So that’s -- we treat that as one. Whatever is there, match
`what’s there. Or No. 2 is remove the cartilage and just match the
`underlying bone and our expert says it’s no big deal either one you do.
`Just like the specification, it’s no big deal, a) or b).
`And so that was how we premised our petition and we felt very
`good arguing and this statement, at least four reasons you can glean from
`this statement, that Radermacher discloses matching the natural surface
`and any physician knows that the natural surface of the femur or tibia is
`coated in that thin, thin layer and that thin layer is so thin it’s the
`compressibility their expert called is microscopic, and so it doesn’t
`interfere with the template and so this statement natural, not pretreated,
`and their expert agrees not pretreated means don’t scrape off the
`cartilage, surface, this is specific to the surface of the osseous structure
`intraoperatively accessed. What’s there when you open it up? So we
`thought there’s at least four reasons why this suggests cartilage and they
`agreed. So this statement that they gave us such a hard time for relying
`on so heavily, they embrace in their own brief.
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`Slide 16 comes right from their brief where they argue that
`Radermacher sought to eliminate preliminary treatments, and this is page
`42 of their opposition, and that a POSITA would have considered
`Radermacher’s statement of a natural not pretreated surface of the
`osseous structure in the context with how Radermacher uses the term
`treatment and they take the treatments and say these are like
`pretreatments and therefore Radermacher’s goal was to eliminate
`pretreatments, and we agreed, and Radermacher achieves its goal of a
`safe, fast and precise procedure by eliminating the preliminary steps
`before attaching the individual template. That’s their brief, and we agree.
`JUDGE WORTH: I know that you have a prepared presentation
`and I want to allow you to do what you’ve prepared, but with an eye on
`the time --
`MR. RE: Yes.
`JUDGE WORTH: -- assuming that we disagree with you about
`what Radermacher discloses, can you talk about the combination of
`Radermacher and Alexander and whether there would have been let’s say
`a reasonable likelihood of success of mating a cutting tool with cartilage,
`assuming we disagree with you about what Radermacher discloses.
`MR. RE: Okay. Well, first of all the specification itself tells you it
`was not a problem. There is no problem, there’s no -- what is the
`problem that they’re presenting where somebody would have some
`reason to believe it wouldn’t be successful? Why would it not be
`successful to put it against the cartilage? And so whatever excuse they
`come up with, Dr. Clark, like it’s compressible, it’s frayed, it might
`degenerate, none of that is in the patent. So I know they’re the ones
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`using hindsight because the patent never explains any problem with the
`cartilage, just as our expert says.
`So, already trying to think of combining references to overcome
`some problem with reasonable expectation of success, that assumes a
`problem. But this record doesn’t reflect a problem and the patent doesn’t
`reflect a problem, so who’s fixing what? Nobody is fixing anything. Just
`like the specification shows, you have two options -- cartilage or bone, or
`any combination thereof. That’s the state of the art. It still is today.
`That’s what the record shows the parties do and so it’s very difficult to
`talk about the problem that they’re trying to overcome because they have
`to kind of make it up and the problem they’re trying to overcome is what
`Radermacher already did.
`JUDGE WIEKER: So let’s assume he’s right. I understand, and
`you understand, that it is the Petitioner’s burden to show that the claims
`would have been obvious in light of --
`MR. RE: Yes.
`JUDGE WIEKER: -- (indiscernible) Radermacher and Alexander,
`so what evidence in the record is there that in that combination, one
`skilled in the art would have expected predictable results or would have
`had a reasonable expectation of success in that combination. I
`understand your position regarding the Patent Owner’s briefing but it
`remains your burden.
`MR. RE: Yes. And the first reason, this is slide 36, let’s go
`through some of the reasons why people would know it’s successful.
`Slide 36, the motivation to combine Radermacher with Alexander. First
`of all, you know there’s only two choices. This is a basic application of
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`KSR. What choices do you have? Two, and the combination of the two,
`and so to us it’s a finite number of identified predictable solutions with a
`reasonable expectation of success because cartilage was never a problem.
`There’s nothing in this record reflecting any problems with matching
`cartilage and the patent doesn’t reflect it either.
`Now obviously doing less, avoiding cartilage removal, simplifies
`the surgery. It’s doing less and their expert agrees a goal is always to
`minimize time. You always want to do surgery as quickly as possible
`and they agree on that and they agree, and their expert says scraping off
`the cartilage often damages the bone. We agree. That’s another reason
`why you wouldn’t just scrape off the cartilage. Leave it on. And also
`relative to their avoiding recess argument that they make, you want to
`have as much surface area as possible. So that’s the third, increase your
`template surface area. Everybody would know that more surface area is
`better.
`JUDGE WORTH: But what is Exhibit 1203?
`MR. RE: 1203 is -- oh, this is Dr. Clark’s deposition at page 196,
`11 to 16, that’s Dr. Clark, Exhibit 1203. He agrees you’d want more
`surface area. That’s common sense. Wouldn’t you want more surface
`area than less? Would you rather have your house on stilts or on a slab?
`Obviously we would have -- this is also Dr. Mabrey, Exhibit 1202 which
`is to the right, paragraphs 30 and 48, where he explains obviously you
`want more surface area and he particularly points out that one of skill in
`the art would know that would be more successful. It’s more successful
`to have more surface area. It’s also consistent with Radermacher’s own
`teaching, and you can look to Radermacher itself to suggest the
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`combination, and Radermacher itself suggests to go to the natural not
`pretreated surface, okay?
`And lastly, this is a -- not less, it’s probably more -- this is a known
`easy substitution. Everyone agrees that Alexander is seven, eight years
`later. Alexander has a wonderful disclosure and in fact, again, what leads
`you to freedom is the patent itself. The patent itself tells you to go to
`Alexander to learn how to map cartilage and the patent itself refers to
`Alexander at least five times, and Alexander itself provides the
`reasonable expectation of success because it explains the detail at which
`you can map the cartilage, and so Alexander, and the Patent Owner
`agrees, Alexander is a great disclosure that the patent itself keeps telling
`the reader to go to to learn how to map cartilage because it has great
`detail.
`JUDGE WORTH: What about the compressibility issue? Is there
`something in the record to rebut Dr. Clark’s testimony about
`compressibility?
`MR. RE: Dr. Clark himself. Dr. Clark, in his deposition, even
`says the compressibility is microscopic he called it and I have that, I’ll
`give you that citation, I have it on one of my slides. I’ll give it to you
`before this hearing’s up. He calls it microscopic. So remember you’re
`not putting huge pressure on the femur when you put the template on.
`You’re not trying to crush it, you’re just trying to place it so that it
`doesn’t move and this -- if we look at Alexander you can see how thin
`microscopic layers of cartilage actually are. Okay.
`JUDGE BUNTING: Counsel, I have a question for you about
`claim 1. You just talked about how microscopic the cartilage is, and in
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`claim 1 it talks about the diseased or damaged cartilage surface. So how
`would you construe the term diseased or damaged cartilage surface?
`MR. RE: It wasn’t construed, but I would just construe that as
`thin. It could be thin. It could be just a little frayed. It could be missing,
`when you say it’s diseased or damaged sometimes it’s missing. So we
`didn’t construe that term.
`JUDGE BUNTING: So the patent itself -- does the patent itself
`describe what diseased or damaged cartilage is?
`MR. RE: Not with respect to these embodiments. It has some
`cartilage repair in other sections of the patent, but with regard to this
`embodiment that we’re talking about I essentially showed you all the
`statements and the patent is consistent that the choices are a) or b), KSR,
`those are your two choices.
`But there’s two more reasons that, on slide 38, why the
`combination. Alexander is later technology. Everyone recognizes it
`shows greater detail that’s not in Radermacher and even Dr. Clark
`recognizes the exciting ground breaking nature of Alexander and the
`detail in which it shows how carefully you can map cartilage, and I think
`that’s another ground and this is from Dr. Clark. And obviously in
`creating the template, what do you think is easier? To create a template
`with a rounded smooth surface or one that’s on stilts to try to match the
`little teeny pieces of exposed bone.
`And so we gave lots of reasons, and if there’s any doubt about the
`combination with Alexander, this is Dr. Clark, and he says on slide 39,
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`“If you were designing a patient specific instrument like
`Radermacher discloses, you would be interested in imaging and modeling
`of an articular surface that Alexander describes.”
`All right. So I don’t know how they can poo-poo Alexander when
`their expert, the patent, relies so heavily on Alexander as the reference
`that shows the details of cartilage mapping.
`The citation to microscopic by the way, it’s the Clark in this
`proceeding, Exhibit 1206 at page 106: line 23 to page 107: line 1, and for
`Mabrey on the reasonable expectation of success that I referred to it’s
`paragraph 94 of the Mabrey declaration. And if there are no further
`questions, I’d like to reserve my time for rebuttal.
`JUDGE WORTH: Okay.
`MR. SUKDUANG: May I begin?
`JUDGE WORTH: Please.
`MR. SUKDUANG: Good morning, Your Honor. Again, Sanya
`Sukduang from Patent Owner ConforMIS. Going to slide 2. The claims
`that are challenged here, the ’025 patent claims, all require a substantial
`negative of diseased or damaged cartilage and the prior art does not --
`JUDGE WORTH: What about claim 15?
`MR. SUKDUANG: Claim 15 is articular surface and it still
`requires diseased or damaged cartilage, just as claim 1. So with respect
`to claim 1, the claim requires cartilage and/or bone and the interpretation
`of that is cartilage would be required to be present, at least under the
`Board’s interpretation of that claim and --
`JUDGE WORTH: Well if there were bone that were matched.
`MR. SUKDUANG: Yes.
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`JUDGE WORTH: Could that anticipate an articular surface that
`was exposed bone?
`MR. SUKDUANG: It could not anticipate here because
`anticipation is not a ground that is present before the Board and, in fact,
`Petitioner actually argued Radermacher alone with respect to all of those
`claims and that ground was not adopted, and the reason why these claims
`were not disclaimed is because there needs to be a motivation to combine
`with a reasonable expectation of success of three references,
`Radermacher and Alexander and Woolson, or Radermacher, Fell and
`Woolson, and Petitioner has not established a reasonable motivation with
`an expectation of success of combining those references. That
`combination is required -- is required -- for those grounds with those
`claims and as you’ve heard today they’re just relying on Radermacher
`alone. That is not a basis for unpatentability here.
`JUDGE WORTH: I believe that the Board was treating the ground
`as a whole in lieu of --
`MR. SUKDUANG: Actually --
`JUDGE WORTH: -- with identifying each individually. MR.
`SUKDUANG: Sure. Actually if you look at the Institution Decision you
`do mention the Radermacher alone and you say that it does not -- and it’s
`a footnote -- it’s not your position as the panel to pick and choose among
`the various options presented by the Petitioner which they’ve done here,
`and so you chose the option where Radermacher teaches bone and
`Alexander and Fell are used to teach the articular cartilage, and that’s
`what they’ve argued here today.
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`Now going to, with respect to the claims at issue here, claim 1, the
`Petitioner here I think fully exemplified why their position is incorrect,
`and in every answer to every question posed by the panel today and
`throughout their presentation their answer was the ConforMIS spec does
`not teach something. That is classic hindsight analysis. The burden is
`not what the spec teaches, and the fact that they need to look to the
`specification to find things shows that they’re not interpreting the prior
`art in light of what the prior art teaches. They’re trying to interpret the
`prior art in light of what the claim requires and again, when you look at
`the transcripts, when you look at the slides, when you look at their
`papers, nowhere do they ever provide any evidence -- either in the
`declaration or in their petition or in their reply, or their slide deck today –
`where you will see the words reasonable expectation of success with
`evidence supporting it.
`Now the prior art, Radermacher, teaches matching a template that
`matches bone. Petitioner has a slide that establishes that and I’ll get to
`that in a moment. Alexander only maps cartilage but Alexander never
`utilizes that cartilage in any implant, tool, or device. Petitioner says that
`ConforMIS, or the Patent Owner, has cited Alexander in its own patent.
`It’s not the same Alexander. It’s a partly different Alexander and that
`Alexander reference is an author where one of our own inventors is the
`author and that Alexander reference actually talks about how you might
`use imaging technology in templates. This Alexander reference they’re
`relying on does not teach that. Why they chose this Alexander reference
`over the other, I don’t know, but that was their choice primarily because
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`the Alexander cited in our patent, it’s questionable as to whether it is
`actually prior art.
`JUDGE WORTH: There is case law about whether a complainant
`may use cross-examination testimony for its affirmative proof. So
`without deciding the issue today, it would be helpful if you could address
`Petitioner’s arguments including what Dr. Clark may have said in the
`deposition.
`MR. SUKDUANG: Sure. So I think we can also use Mr.
`Mabrey’s testimony as well, and let me jump to slide 3. Here again, all
`the requirements are three prior art references. They have the burden of
`establishing obviousness in combination of three references in total.
`Would you like me to address Dr. Clark first or address Dr. Mabrey first?
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`JUDGE WORTH: Either one.
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`MR. SUKDUANG: Either one. Let me go to Dr. Mabrey. These
`statements, and you’ve seen them before out of Radermacher, Petitioner
`argued that their paragraph 1 on page 12 is the specific discussion that
`should be relevant. No.
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`JUDGE WIE
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