UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`COMFORMIS, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00373 (Patent 8,551,169 B2)
`Case IPR2017-00510 (Patent 7,981,158 B2)
`Case IPR2017-00511 (Patent 7,981,158 B2)
`____________
`
`Record of Oral Hearing
` Held: March 13, 2018
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`
`
`
`Before PATRICK R. SCANLON, BEVERLY M. BUNTING, JAMES A.
`WORTH, and AMANDA F. WIEKER, Administrative Patent Judges.
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`Case IPR2017-00373 (Patent 8,551,169 B2)
`Case IPR2017-00510 (Patent 7,981,158 B2)
`Case IPR2017-00511 (Patent 7,981,158 B2)
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`
`CHRISTY G. LEA, PARTNER
`Knobbe, Martens
`2040 Main Street
`14th Floor
`Irvine, California 92614
`(949) 760-0404
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`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
` SANYA SUKDUANG, PARTNER
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`901 New York Avenue Northwest
`Washington, D.C. 20001
`(202) 408-4377
`
`
`
`
`The above-entitled matter came on for hearing on Tuesday, March 13,
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`2018, commencing at 10:00 a.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`Case IPR2017-00373 (Patent 8,551,169 B2)
`Case IPR2017-00510 (Patent 7,981,158 B2)
`Case IPR2017-00511 (Patent 7,981,158 B2)
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`P R O C E E D I N G S
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`JUDGE WIEKER: Good afternoon, everyone. This is a consolidated
`oral hearing for case numbers IPR2017-00373, IPR2017-00510,
`IPR2017-00511, between Petitioner Smith and Nephew, Inc. and Patent
`Owner, Conformis, Inc. The '373 proceeding concerns U.S. Patent Number
`8,551,169 and the '510 and '511 proceedings concern U.S. Patent Number
`7,981,158. I'm Judge Wieker. I'm accompanied by Judge Worth and Judge
`Bunting for the '373 proceeding, and with respect to the '510 and '511
`proceedings, I'm accompanied by Judge Worth and Judge Scanlon. Judge
`Bunting and Judge Scanlon are appearing remotely. Counsel for the parties,
`please introduce yourselves for the record starting with Petitioner.
`MS. LEA: Good morning, Your Honor. This is Christy Lea from
`Knobbe Martins for Petitioner Smith and Nephew. With me are my partners
`Ben Anger and Colin Heideman. I also have two partners observing today.
`JUDGE WIEKER: Thank you. Patent Owner.
`MR. SUKDUANG: Good morning, Your Honor. Sanya Sukduang
`from Finnegan and Henderson on behalf of the Patent Owner Conformis. I
`have with me my colleague Tim McAnulty, Kassandra Officer, Sydney
`Kaetle, Dan Klodowski, and from Conformis, Patricia Davis.
`JUDGE WIEKER: As we stated in our amended hearing order from
`February 28th, each party will have a total of 40 minutes to present
`arguments for all three proceedings. Petitioner will proceed first and may
`reserve rebuttal time. Patent Owner will respond to Petitioner's case and
`may not reserve rebuttal time. Petitioner will then use any reserved rebuttal
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`time to share their response to Patent Owner's case. I'd like to remind the
`parties that Petitioner bears the burden of proving any proposition of
`unpatentability by a preponderance of the evidence. Also, this is a reminder
`the hearing is open to the public and a full transcript of the hearing will
`become part of the record. Finally, please bear in mind that Judge Bunting
`and Judge Scanlon are attending this hearing by video. Please identify
`clearly and specifically each demonstrative exhibit, for example, by slide or
`screen number, to ensure the clarity of the transcript and to ensure that our
`remote Judges can follow your presentation. With that, Ms. Lea, you may
`begin. Would you like to reserve any rebuttal time?
`MS. LEA: I would, I'd like to reserve 10 minutes.
`JUDGE WIEKER: Okay.
`MS. LEA: And may I hand up my slides?
`JUDGE WIEKER: Of course. Whenever you're ready, please
`proceed.
`MS. LEA: Certainly. We can start with slide 2. Slide 2 gives an
`outline. Today I'm going to talk about the challenged patents, the prior art,
`as well as the motivation to combine the prior art and finally I will address
`Conformis's co-registration arguments. We'll move on to slide 3. Slide 3
`shows Claim 1 from the '158 patent and I know it looks like a long claim but
`it's actually really simple when you boil it down. All of the challenged
`claims are method claims. Method of making a patient-specific instrument,
`just like Claim 1 here, and the claims require obtaining first image data and
`obtaining second image data. And the first image data is used to make the
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`patient-specific surface of the instrument, and the second image data is used
`to orient the guide that aligns the cuts on the instrument.
`JUDGE WORTH: Can I ask you, counselor, why would you
`underline and bold “surface of the joint”?
`MS. LEA: I'm glad you asked. So, the patient-specific surface
`matches the surface of the joint, and the surface of the joint in the '158 IPR
`is a construed term and I believe we have that claim construction on the next
`slide, slide 4. So, if you recall from the past two hearings those arguments
`were about whether the claims require matching cartilage and whether the
`prior art disclosed matching cartilage. Some of the claims in those past two
`cases require matching articular surface and the Board construed that surface
`just like it had in the '158 IPR, to mean the surface of an articulating bone
`that included cartilage and/or exposed subchondral bone. So, in this case the
`claims can match cartilage or bone or both. And Conformis is not disputing
`that the prior art discloses matching bone, so there's no dispute about
`cartilage in this hearing.
`JUDGE WORTH: Do you think that the construction of (inaudible)
`the '373 case?
`MS. LEA: In the '169 patent, yes, it does. In that case you're
`matching the joint which would include the bone or cartilage or both.
`JUDGE WORTH: Can you walk us through how it applies to the
`CAOS and Swaelens references in terms of matching the surface of the
`joint?
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`MS. LEA: Sure. So, those references disclose a patient-specific
`instrument that matches the surface of the joint. CAOS, for example, uses
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`CT scan the surface of the joint and the CT image is going to allow you to
`match the bone, at least the bone in the case of CAOS, and there's no dispute
`about that.
`JUDGE WORTH: What about Swaelens?
`MS. LEA: And the same for Swaelens.
`JUDGE WORTH: Okay. And if it's matching the bone is that
`matching the surface of the joint?
`MS. LEA: Under the claim construction it is, which means matching
`the cartilage or any exposed bone, so whatever's there. It can be just bone or
`bone and cartilage.
`JUDGE WORTH: Okay. And is there anything in the record to
`connect the dots that matching bone matches the surface?
`MS. LEA: There is, we can give you those cites, if you would like.
`Again, there's no dispute about this limitation but we can get them for you
`by the end of the hearing, if you would like.
`JUDGE WORTH: That would be helpful.
`MS. LEA: Okay. Sure, will do. Slide 5, if we could go to slide 5.
`Slide 5 focuses on what is in dispute in this hearing and what the claims are
`covering. The claims here are about two image data sets so, like I just said,
`making a patient-specific instrument where the first image data controls the
`patient-specific surface, and in most of the claims it's not specified what the
`image data must be. It could be either CT or MRI, those were the two
`imaging techniques used and practiced for making a 3D image of the
`patient-specific surface. There are a -- there's one claim that requires CT
`and a handful that require MRI. Then the second image data and about half
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`the claims is the specified as to what that needs to be. The other half require
`X-ray image data, and X-ray image data has long been used to determine the
`patient's mechanical and anatomical axis to align cutting guides. So, that's
`what Conformis has claimed here, in the first image data they claimed all
`possible ways of doing it and with the second they claimed the standard way
`of doing it. Now, Conformis has limited its patentability arguments to the
`half of the claims that require X-ray data for the second image data, so
`there's no dispute that the prior art discloses first and second image data
`from making a patient-specific instrument. Slide 6, slide 6 focuses on the
`broadest claims. So, these are the claims that simply require two image data
`sets. They don't specify what the image data must be. Conformis made no
`patentability arguments about these claims whatsoever, and I list the 31
`claims for you on slide 6. And that is because they admit that CAOS
`discloses making a patient-specific instrument using first and second image
`data. In the case of CAOS it's CT image data and a CT topogram. Slide 7,
`slide 7 focuses in on the first image data combined with the claims that
`require the second image data be X-ray image data. So, again, in most of the
`claims there's no specification as to what the first image data must be. One
`claim, Claim 4 in the '158, required MRI. Claim 7 in the '158 required CT.
`All of the claims listed on slide 7, there's 42 of them, require the second
`image data be X-ray image data. And here there's no dispute the prior art
`discloses every limitation. Conformis simply argued that there's no
`motivation to modify the prior art, to modify CAOS's use of CT topogram to
`use MRI or X-ray. If we could go to slide 8. Slide 8 shows the claims in the
`'169 patent. There are only two claims; Claims 29 and 30, again, these
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`claims are very similar: creating a patient-specific instrument where the first
`image data is MRI and the second image data in the dependent claim is
`X-ray image data. So, we have -- between the two patents we have three
`claims to MRI/X-ray combination. Again, Conformis argued no motivation
`to modify CAOS's use of CT topogram to use MRI/X-ray. So the
`MRI/X-ray combination would render all claims unpatentable except for
`Claim 7, the CT/X-ray claim in the '158 patent. If we could go to slide 9,
`please. Slide 9 is an overview of the grounds in the first '158 IPR. Now, all
`of the ground are based upon CAOS combined with Woolson, and then there
`are a few extra references for some dependent claims. There's no dispute
`about the limitations in those dependent claims, so I will not focus on those
`additional references at the hearing today. I also want to add that all of the
`grounds in the '158 also included Alexander, which was matching cartilage
`or mapping cartilage is why we've included Alexander, and because we
`didn't know at the time when we filed these that Conformis would admit that
`all these claims require is matching bone.
`JUDGE WIEKER: Can I stop you for a minute? So, in your reply
`you talk a bit about the CAOS reference alone rendering obvious certain
`claims because the topogram can be considered an X-ray image, where do
`you have support for that in the initially filed petition?
`MS. LEA: So, in the petition we do refer to the topogram as an
`alternative to X-ray. We also cite Adler that explains that it is X-ray image
`data. But we, again, when we filed the petition we had no idea that
`Conformis's expert was going to admit in his declaration on the Patent
`Owner Preliminary Response that a topogram is X-ray image data. The
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`Board then relied upon that admission in its institution decision in the '158
`IPRs and found that a topogram is X-ray image data. So, certainly from that
`very early institution decision Conformis was aware how this Board was
`using the admission from its expert, its radiology expert, and certainly had
`an opportunity to respond to the Board's use of that and chose not to do so.
`They said nothing about it in their Patent Owner Response. They pretended
`like it wasn't there. They went out and hired a new radiology expert who
`never disputed that a topogram is an X-ray or otherwise commented on the
`first expert's testimony or the Board's use of that testimony.
`JUDGE WIEKER: Let's be clear. The four grounds set forth in the
`petition do not rely on a single reference ground?
`MS. LEA: That is correct, they do not, but the Board did find that a
`topogram is an X-ray.
`JUDGE WIEKER: I understand, thank you.
`MS. LEA: So, I will move on. We show the grounds also on slide 10.
`We'll go on to slide 11. Again, the overview for the ground of the '169.
`Here, for the two claims we have two sets of grounds; the CAOS plus
`Woolson and Radermacher, as well as Swaelens and Woolson. We can go
`on to slide 12. Now, in this case there's no dispute that the prior art discloses
`each claim limitation. Slide 13. So slide 13 is an overview of CAOS.
`CAOS discloses a patient-specific instrument with two sets of image data.
`There's no dispute that is discloses a patient-specific surface derived from a
`CT image. It discloses a guide oriented from the topogram X-ray image data
`and the Patent Owner admits those disclosures in its response at 23. There's
`no dispute that CAOS discloses the planned incorporation of MRI in light of
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`CT drawbacks. So, in light of all the admissions on the disclosures of
`CAOS, CAOS discloses the two image combination in the 31 claims that we
`talked about. The first image X-ray combination and a single CAOS
`instrument, and then they disclose a suggestion to use MRI as an
`improvement and that relates to the three MRI claims. Slide 14, please.
`Now, a topogram is an X-ray. Conformis's first radiology expert admitted
`that a topogram is an X-ray image. Certainly, Smith and Nephew's experts
`agree with him and the literature says that a topogram is an X-ray image.
`Like I said, the Board relied upon Dr. Gaskin’s admission and found that a
`topogram is an X-ray and Conformis certainly had notice and an opportunity
`to respond and chose not to do so.
`JUDGE WORTH: When you say the Board found, you mean in the
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`DI?
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`MS. LEA: I'm sorry?
`JUDGE WORTH: You mean in the decision on institution?
`MS. LEA: That's correct, in the '158.
`JUDGE WORTH: So, that would be a preliminary factual finding?
`MS. LEA: It was, and there's no dispute about that factual finding and
`there's overwhelming evidence to support it. If I can go on to slide 15.
`Now, there is another reference for the X-ray limitation, Woolson discloses
`orienting guides relative to a mechanical axis using X-ray. This was the
`standard way of -- orienting a guide was to use conventional X-ray to do so.
`The mechanical axis runs from the center of the femoral head all the way
`down to the -- you can see the femoral cut line at the bottom of the femur
`there, the center of the intercondylar notch, and you can see the same thing
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`on the tibia. Now, there is some confusion, I think, in the case about
`whether the mechanical axis runs just for the femur and just for the tibia or
`for the entire leg. Certainly the axis is drawn on the femur, but an evaluation
`of the entire leg must be performed for a lot of reasons. Number 1, the
`orthopedic surgeons want to see the leg in its physiological load, that can
`effect the axis, there might be adjustments that are made. They want to see it
`in normal use, they want to check joint spacing, they want to correct for
`various conditions, that's bow legged or knock kneed. All of that goes into
`the mechanical axis determination based upon a full leg X-ray. Slide 16, this
`is an overview, just all of the limitations are disclosed. We've talked about
`CAOS and Woolson. The additional references disclose the limitations as
`well, there's no dispute about that, and I'll move on to motivation to
`combine. So, slide 17, we will focus on the motivation to use MRI and,
`again, there's three claims that call out MRI but using MRI would render all
`of the claims unpatentable except for Claim 7 of the '158 patent. Slide 18,
`so our best motivation to combine comes from the reference itself. CAOS
`says we plan to incorporate MRI, it's hard to imagine a better suggestion to
`one of ordinary skill in the art then when you have the reference itself saying
`the next step is to use MRI. Conformis tries to dismiss this motivation as
`generic. I'm not sure exactly what they're looking for, but when you have a
`reference say we plan to use MRI that's certainty a suggestion for one of
`ordinary skill. There's plenty of Federal Circuit case law that says it's the
`normal desire to improve upon what is already known and certainly one of
`ordinary skill would look to this and say let's try MRI. Slide 19, and one of
`those reasons is CAOS actually recognizes the drawbacks of CT imaging.
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`And then goes on to say we plan to incorporate MRI. Slide 20, now, all of
`the prior art treats MRI and CT as interchangable; Radermacher, Swaelens,
`all say use MRI or CT. Schiffers suggest the MRI improvement and if you'll
`recall from the '953 and '025 hearings Conformis treated MRI and CT as
`interchangable in those hearings. Slide 21, and this is a simple KSR case. In
`practice there are only two options for imaging the patient-specific surface in
`this case and those are MRI and CT. This is Conformis's radiology expert,
`Dr. Kneeland. So, in practice, MRI and CT were the only techniques used
`as of 2001 to develop a 3D image of a patient's joint, I believe that's correct.
`That is correct is --
`JUDGE WORTH: This might be -- maybe you can finish your
`sentence.
`MS. LEA: I was just going to say and in their KSR we have finite
`choices with a reasonable expectation of success.
`JUDGE WORTH: This might be a good time to address Patent
`Owner's argument that, and this is the '373 case, that in the Swaelens's
`combination with Woolson that it would be difficult to combine a pixel with
`a voxel because there is the 2D to 3D difference, can you speak to that?
`MS. LEA: I sure can. So, there's a lot to say. I think you're referring
`to co-registration.
`JUDGE WORTH: I'm not. Let me give you a better place to address
`it. In Patent Owner's Response, page 60 of Patent Owner's Response, they're
`talking about combining pixels and voxels.
`MS. LEA: And I will tell you that that is a sideshow. First of all, the
`claims do not require combining pixels and voxels, or any type of
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`co-registration for that matter, and what they're referring to is the fact that
`we're determining the mechanical axis, based on the X-ray image data. So,
`we're talking about a simple transfer of that mechanical axis to the MRI for
`the 3D image, it's simply drawing a line on the 3D image. Doesn't matter
`about the pixels or the voxels. So, why don't we dive into co-registration a
`little bit deeper on slide 37. So, Petitioner has shown a motivation to
`combine, we have motivations in the reference themselves to use MRI, we
`had the long standard of care of using X-ray to determine mechanical axis.
`It's how it will help their expert does it, our expert does it, how it's always
`been done. We had the reasonable expectation of success by the fact that all
`of the references suggest using MRI. And they never suggest a problem
`with doing so, and all of those references would have required a use of
`determining the mechanical axis using X-ray. So, Conformis's response to
`all of those arguments is that one of ordinary skill in the art would not have
`known how to combine the images, how to co-register the images. But our
`response to that is co-registration was well-known and it's not in these
`claims. Go to slide 38. So, first of all, the patent admits that co-registration
`was well-known. As will be appreciated by those of skill in the art, imaging
`techniques can be combined if desired. Multiple tests can be combined.
`Image fusion of different imaging modalities can be combined. There's
`nothing in the specification that says there's a problem combining images,
`there's nothing in the specification teaching how to combine images, there's
`nothing in the specification explaining what Conformis did to overcome any
`alleged co-registration problem. We'll move on to slide 39, the admissions
`in the specification about combining images are binding on Conformis for
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`purposes of this obviousness inquiry. I put up this basic patent law
`proposition because Conformis argued at the prior hearing that Smith and
`Nephew cannot use the specification against Conformis, and that's just
`legally incorrect. You can see the Federal Circuit in PharmaStem and Smith
`and Nephew supporting this proposition as well as this Board applying it.
`JUDGE WORTH: I think it's a complex issue. There is a sensitivity
`against using hindsight and so that's one of the considerations and the other
`consideration is the interpretation of § 311 in terms of what constitutes a
`reference cognizable under § 311 and I would say that it's a complex area.
`MS. LEA: Well, I would say that the Smith and Nephew v. Rea case
`is completely on point in this situation. It's a situation where the
`combination was disclosed in the prior art, all the limitations were disclosed,
`and the patentee argued that one of ordinary skill would not have known
`how -- it would not have worked if one of ordinary skill had combined them.
`Just as Conformis is saying, you would not have been able to combine the
`MRI and X-ray, and then they're turning around and saying but we did, we
`claim the MRI/X-ray combination, we claim those together. Well, how did
`you make it work, Conformis, what did you do. Smith and Nephew, the
`Federal Circuit in that case, held an unclaimed, undisclosed feature cannot
`be the basis of patentability. Here we have an unclaimed feature and one
`they've admitted in the spec as well-known. So, not even undisclosed but
`they've said combining images were well-known. I'm on slide 39 let's go to
`slide 40. So, I just said the claims do not recite co-registration remember the
`obtaining first image data, obtaining second image data there's no next step
`that says combining image data, co-registrating image data. There's no
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`solution to the co-registration problem, alleged problem in the claim.
`There's no step about making co-registration easier, faster, better. There's
`nothing in the spec about that either. If we go to slide 41.
`JUDGE WORTH: Would you agree that Woolson didn't find a
`problem with using an X-ray to accomplish finding the mechanical axis?
`MS. LEA: That is correct. Woolson used an X-ray to determine the
`mechanical axis, discloses the use of an X-ray to determine mechanical axis.
`JUDGE WORTH: And Woolson indicates that it's the background
`art, it's part of the standard background art?
`MS. LEA: Yes, it's acknowledging that X-ray is the standard way of
`determining the mechanical axis. And their expert acknowledges that over
`and over again as well. Slide 41, the patents do not disclose how to
`co-register image -- this is their expert, Dr. Kneeland, radiology expert
`saying the inventors are really just describing the various possibilities of
`combining images but without really specifics on what can be done. It's just
`a background on combining images. Slide 42, this is from the Smith and
`Nephew v. Rea case that I already talked about and actually I was at that
`hearing and one of the Federal Circuit Judge's actually asked, well, how did
`you make it work, Patent Owner, what did you do to make this work and so
`they put that in their opinion, that Patent Owner's argument that the prior art
`combination would have been inoperable naturally raises the question of
`how the Patent Owner managed to make such a combination work. In that
`case, Patent Owner responded that we invented a specialized screw and the
`Federal Circuit said that's not in your claim, that's not in your specification.
`An unclaimed, undisclosed feature cannot be the basis for finding a patent to
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`be non-obvious. Slide 43, so I just addressed as a legal matter
`co-registration cannot preclude a finding of reasonable expectation of
`success. We have all of the prior art saying use MRI we have none of the
`prior art saying there's a problem with using MRI and X-ray. All of the prior
`art's saying X-ray is the standard of care and so now we come down to as a
`factual matter, co-registration was not a problem. Slide 44, Conformis has
`one sentence to support it's co-registration argument and that's in Dr.
`Kneeland's declaration. Co-registration of images is difficult,
`time-consuming, and often inaccurate, it claims. But we can go to slide 45.
`Dr. Kneeland admitted that he provided no underlying facts or data to
`support his opinion and under the regulations that opinion is entitled to no
`weight. Especially when we go to slide 46 and we consider that Dr.
`Kneeland is not an expert on co-registration, he was not working on
`co-registration in 2001, he did not review or search for any literature on
`co-registration, he does not know how long it took to co-register images in
`2001, and he does not know which co-registration methods are accurate and
`which are inaccurate. Slide 47 --
`JUDGE BUNTING: Counsel, excuse me, I have a question. So, what
`is the level of skill in the art that's required here?
`MS. LEA: So, the level of skill in the art is as the Board found in its
`institution decision --
`JUDGE BUNTING: You mean our preliminary finding?
`MS. LEA: Yes, that's correct. So, and I don't have the words right in
`front of me but it was if someone practicing orthopedic surgery for several
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`years and with a general understanding of imaging technologies as an
`orthopedic surgeon would have.
`JUDGE BUNTING: So, is it your position that Dr. Kneeland is not of
`skill in the art?
`MS. LEA: That is correct. He is an expert on imaging technologies
`but he is not an orthopedic surgeon.
`JUDGE BUNTING: Would one of skill in the art have to be an
`orthopedic surgeon?
`MS. LEA: I believe that's what we have in our proposal and everyone
`agrees on the level of skill in the art.
`JUDGE BUNTING: Thank you.
`MS. LEA: Okay. So, to sum up on Dr. Kneeland his opinion that
`co-registration was difficult, time-consuming, or less accurate was based
`upon hearsay, simply talking to colleagues that he admitted did not perform
`co-registration. Slide 48, Smith and Nephew submitted multiple literature
`references that demonstrate that co-registration was not a problem. It was a
`mature technology in 2001, around for nearly two decades, applied at
`clinical practice. Slide 49, another reference that says co-registration is
`easy, fast, automated. This one actually discusses co-registration of CT or
`MRI with x-ray. Slide 50, co-registration, this reference actually discloses a
`method for co-registration of X-ray images with preoperative MRI and CT
`scans. Disclosed that co-registration is accurate and can be done in just ten
`seconds and they use landmark co-registration in that reference. Slide 51,
`Dr. Gold, he is Smith and Nephews' radiology expert, a radiologist at
`Stanford University testified in 2001 that a radiologist would have
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`understood that co-registration of either CT or MRI image data of the knee
`joint with either a topogram or X-ray, conventional X-ray, would have been
`technically feasible, relatively straightforward, fast and accurate, and that's
`supported by the literature. Slide 52, both, Dr. Mabrey, our orthopedic
`surgeon, and Dr. Gold, the radiologist, testified that co-registration is not
`necessary in this case. You can simply transfer a single line, a mechanical
`axis from the X-ray image over to the MRI. You can do that manually or
`digitally and Dr. Mabrey explained that that would have been relatively
`straightforward in 2001, to manually transfer, that single line from the X-ray
`to the MRI or CT and Dr. Gold on slide 53, agreed with Dr. Mabrey that you
`would simply transfer that single line over to the MRI. That's my time. If
`there's no further questions I will sit down.
`JUDGE WIEKER: Thank you. Mr. Sukduang, whenever you're
`ready to proceed.
`MR. SUKDUANG: Sure. Good morning, Your Honors. Sanya
`Sukduang for Patent Owner Conformis. I'm wondering why I'm standing up
`today because counsel believes that there are actually no disputes with
`respect to what the record discloses. We did submit a paper in response, we
`did submit observations, we did submit papers in response to the Petitioner's
`new arguments in the file, and there are quite a few disputes as to what the
`record actually discloses. There's actually quite a few disputes as to the
`record or representations that counsel presented today that I'll try to address
`during the course of my proceedings, but I want to start with slide 2.
`Petitioner bears the burden of establishing that there is a motivation to
`modify the primary prior art reference, CAOS, and to deconstruct CAOS,
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`which would remove the use of CT images and