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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MAKO SURGICAL CORP., :
` :
` Petitioner, :
` :
` vs. : Case No.
` : IPR2015-00630
`BLUE BELT TECHNOLOGIES, :
`INC., : Patent No.
` : 6,205,411
` Patent Owner. :
`
` January 12, 2016
`
` Oral deposition of KEVIN CLEARY,
`M.D., taken at the offices of GIBSON DUNN,
`1050 Connecticut Avenue, NW, Washington, DC,
`20036-5306, beginning at 10:31 a.m., before
`Stacey L. Daywalt, a Court Reporter and a
`Notary Public in and for the District of
`Columbia.
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`212-490-3430
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`Mako Exhibit 1010 Page 1
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`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MAKO SURGICAL CORP., :
` :
` Petitioner, :
` :
` vs. : Case No.
` : IPR2015-00630
`BLUE BELT TECHNOLOGIES, :
`INC., : Patent No.
` : 6,205,411
` Patent Owner. :
`
` January 12, 2016
`
` Oral deposition of KEVIN CLEARY,
`M.D., taken at the offices of GIBSON DUNN,
`1050 Connecticut Avenue, NW, Washington, DC,
`20036-5306, beginning at 10:31 a.m., before
`Stacey L. Daywalt, a Court Reporter and a
`Notary Public in and for the District of
`Columbia.
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`Mako Exhibit 1010 Page 1
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`Page 2
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`A P P E A R A N C E S :
`
`MORRISON & FOERSTER
`BY: MATTHEW KREEGER, ESQ.
`425 Market Street
`San Francisco, California 94105
`(415) 268-7000
`mkreeger@mofo.com
`Representing the Petitioner
`
`GIBSON DUNN
`BY: BRIAN M. BUROKER, ESQ.
`1050 Connecticut Avenue, NW
`Washington, DC 20036-5306
`(202) 955-8500
`bburoker@gibsondunn.com
`Representing the Patent Owner
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`Mako Exhibit 1010 Page 2
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`Page 3
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` I N D E X
` - - -
`Testimony of: KEVIN CLEARY, M.D.
`By Mr. Kreeger 4
`By Mr. Buroker 43
`
` - - -
` E X H I B I T S
` - - -
`EXHIBIT NUMBER DESCRIPTION PAGE MARKED
`
`Exhibit 1016 '976 patent 25
`
` - - -
` (Exhibit attached to
`transcript.)
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`Page 4
` KEVIN CLEARY, MD, after having
`been first duly sworn, was examined and
`testified as follows:
` - - -
` EXAMINATION
` - - -
`BY MR. KREEGER:
` Q. Morning, Dr. Cleary. My name is
`Matthew Kreeger. I know we met off the
`record. And I'm here today to take your
`cross-examination by deposition.
` Have you given a deposition
`before?
` A. I have, but it's been about five
`or six years.
` Q. Were you serving as an expert
`witness in that case?
` A. I was.
` Q. And what was that case about?
` A. To be honest, I can't remember
`the details of that case right now.
` Q. Anything to do with patents?
` A. It had to do with patents, yeah.
` Q. And it's just the one time that
`you've been deposed?
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`Page 5
` A. I keep thinking there was a time
`before that about ten years ago, but I only
`recall the one time right now.
` Q. Do you remember what the
`technology was that was involved in that prior
`case?
` A. You know, I want to say it was
`in the medical robotics or image-guided
`surgery field, but I couldn't be absolutely
`sure of that.
` It was certainly a technology
`case.
` Q. And do you remember any of the
`parties involved?
` A. Medtronic was one of the parties
`involved with that, but I don't remember the
`second party.
` Q. And when were you initially
`contacted to become involved in this case?
` A. It was in the fall of this year.
`So I think it was in the October time frame.
` Q. And who contacted you?
` A. I want to say it was Omar from
`this firm who was my first point of contact.
` Sorry. I'm not supposed to look
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`at him.
` Yeah, Omar from this firm I
`think was my first point of contact.
` Q. I see. And how was the project
`described to you at that point?
` A. Right. So he just said he had a
`patent case and asked if I would be free in
`the upcoming weeks and have some time to help
`out with it. And I think that was the initial
`contact, you know, first whether I was allowed
`to do this type of work as part of my job at
`Children's.
` And I said that I would be able
`to help, but I would like to know a little bit
`about the case. And then we went from there.
` Q. Did you know this attorney from
`Gibson Dunn before the call or was this a
`call --
` A. I did not -- I had never met
`attorneys here before.
` Q. And how many hours have you
`spent working on the matter since the
`beginning?
` A. Let's see. I think I probably
`spent about 20 hours preparing the initial
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`deposition.
` Q. Declaration?
` A. Declaration.
` And then we spent some time on
`Friday and on Monday just the last couple days
`preparing for today's testimony.
` Q. Okay. So you actually worked on
`two different declarations for the two
`different --
` A. Yeah, the '411 and '582 as I
`understand it.
` Q. And you'd estimate 20 hours
`working on both of them?
` A. Yes.
` Q. In total?
` A. In total. Well, that was to
`make the declaration and then some time in the
`last -- Friday and Monday to prepare for today
`and to review what I had put in the
`declaration.
` Q. So roughly 20 hours in the
`course of preparing both declarations and then
`additional time preparing for the deposition?
` A. Yes.
` Q. In your declarations you refer
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`to various prior art patents.
` How did those patents come to
`your attention?
` A. Those patents were brought to my
`attention by the attorneys here.
` Q. You hadn't seen them before the
`case?
` A. I may have seen some of them
`before the case there, but I don't
`specifically certainly remember any time going
`over them in detail.
` I had certainly seen the Taylor
`article before. It's a well known article.
` Q. Are you familiar with a patent
`that's where Tim Luth is the named inventor?
` A. I am not familiar with the
`patent. I do know Tim Luth.
` Q. So the attorneys at Gibson
`didn't ask you to look at this patent?
` MR. BUROKER: I'll allow you to
`say yes or no.
` I don't want to reveal any work
`product, but you can say yes or no.
` THE WITNESS: No, I have not
`looked at that patent.
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`BY MR. KREEGER:
` Q. Are you aware that Blue Belt has
`retained a separate expert to offer opinions
`about that patent?
` A. I am not aware.
` Q. And I gather you've brought --
`well, why don't you describe what it is you've
`brought with you today?
` A. Sure. One is a notebook with
`materials on the '582 patent, and the other
`one is a notebook with materials on the '411
`patent.
` Q. And what sort of materials are
`in these notebooks?
` A. So in this one, we have the
`patent itself. We have my declaration here.
`We have the Taylor article and a number of
`other related items.
` Q. Are there any markings or are
`these just clean copies?
` A. These are clean copies.
` Q. In both cases?
` A. In both cases.
` Q. Okay. So I'm going to ask you
`to look at certain exhibits. You should feel
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`Page 10
`free to look at the ones in your notebook or I
`can pass them to you or --
` A. Sure. I can take what you're
`going to give me. And then if I need to refer
`to here, I'll do that.
` Reminds me of the old days of
`NIH review where they used to send us a box of
`materials to review, and now everything's
`electronic.
` (Discussion was held off the
`record.)
`BY MR. KREEGER:
` Q. I'm going to show you what's
`been previously marked as Exhibit 2004 in
`IPR2015-629.
` This is your declaration in the
`'582 case. Is that right?
` A. Can I just check it with the one
`that I have right here?
` Q. Of course.
` A. (Reviewing documents.)
` Okay. Yeah, I agree.
` Q. All right. So I'm just going to
`refer to the beginning portion where you talk
`about your qualifications.
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` A. Okay.
` Q. In Paragraph 4 you describe some
`work that you -- are you still technically the
`director of the Bioengineering Initiative?
` A. I am.
` Q. And what are your
`responsibilities as technical director?
` A. So we have an institute at
`Children's Hospital just up the road here to
`develop biomedical technology for pediatrics.
` So I direct a group with a
`couple faculty and some staff, and we build
`biomedical devices, including image-guided
`surgery and medical robotics for pediatrics.
` Q. And are you currently a
`professor at George Washington?
` A. Yes, I am.
` Q. And what is your role there?
` A. So Children's actually is the
`pediatrics department for George Washington,
`and so our faculty appointments are all done
`through George Washington.
` And we have some involvement
`with them, but most of my work is at the
`Children's main campus.
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` Q. Understood. Is your post with
`the George Washington, is that in the
`engineering school or medical school or
`something else?
` A. It's actually -- the way it's
`set up it's the School of Health Sciences
`there.
` But we do get the faculty
`tuition benefits, but my kids didn't go there.
` Q. Have you ever held an academic
`position in a school of engineering?
` A. I have not.
` I've had, I guess it might be
`called an adjunct in that I've taught medical
`robotics in the University of Maryland some
`time ago.
` And we do a lot of work with
`University of Maryland, including sponsoring
`some senior design projects, but I've not held
`a full-time appointment.
` Q. In Paragraph 5 you say that
`you've developed image-guided medical
`intervention technologies.
` Can you give me an example?
` A. Let's see. Right. Yeah. Sure.
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` So recently we developed a
`system for PET CT image guidance that was
`employed at Georgetown, and we just did
`one case where we would take the PET and the
`CT images and fuse them and then provide
`navigation and guidance for the doctor to do a
`biopsy procedure.
` Q. That's an imaging system to
`assist the surgeon. Is that right?
` A. Right. I would call it an
`image-guided navigation system or a computer
`aided surgery system.
` Q. Have you ever worked on a robot
`surgical system?
` A. Yes. Also when I was at
`Georgetown, we developed, which I think was
`still the world's first system, with Johns
`Hopkins for robotically assisted nerve blocks,
`and we actually did a clinical trial with ten
`patients.
` Q. That's what's described in
`Paragraph 6?
` A. Let me see. Right. The first
`clinical trial of robotically assisted spine
`blocks at Georgetown.
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` Yep. That's correct.
` Q. Do you or your lab receive any
`support from corporate sponsors?
` A. We typically get most of our
`funding from NIH.
` I think in the past we've done
`some small projects from corporate sponsors,
`but we don't have -- I personally don't have
`current funding.
` Well, let's see. I do have some
`small business grants that are done in
`conjunction with small businesses. So I don't
`know if that counts, but that would be the
`type of funding I've had with corporations.
` Q. Have you had any connections
`with Blue Belt prior to this case?
` A. No.
` But one of my post docs does
`work in Blue Belt, former post docs.
` Q. Who is that?
` A. Sorry?
` Q. Who is that?
` A. His name is Rahul Khare,
`K-H-A-R-E.
` Q. He left his work as a post doc
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`with you to join Blue Belt?
` A. That's correct.
` Q. Have you had any connections
`before this case with Smith & Nephew?
` A. No, I have had no connections
`with Smith & Nephew.
` Q. Have you had any connections
`with Stanmore?
` A. I have not had any connections
`with Stanmore.
` Q. You mentioned you know Dr. Luth.
` How do you know Dr. Luth?
` A. We've worked in the same field.
` He, many -- 15 years ago,
`20 years -- 15 years ago probably I visited
`him at Charité in Berlin where he had a
`operating room that was developing
`image-guided surgery and medical robotics.
` And I see him periodically at
`conferences.
` Q. What about Dr. Howell? Do you
`know Dr. Howell?
` A. I do know Dr. Howell.
` Q. And how do you know him?
` A. Same thing, from working in the
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`joint field.
` I see him at conferences and we
`certainly knew each other professionally, but
`I'm not sure we know each other well.
` Q. Does he have a good reputation?
`Dr. Howell, does he have a good reputation in
`the field?
` A. I think so. I think he does
`good work.
` And anybody who survives in this
`field for a while I think is doing okay.
` Q. Do you know Dr. DiGioia?
` A. I do know Dr. DiGioia.
` Q. How do you know him?
` A. I think same thing. I had gone
`to some of the early conferences in the field.
`He had ordered an organized MIS-CAOS
`conference in Pittsburgh, which I want to say
`was around 2000.
` But again, I don't know him
`well, and I'm not sure that he would
`personally recognize me.
` Q. How about the founders of Blue
`Belt?
` There's a Dr. Jaramaz.
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` Do you know him?
` A. I do know him.
` Q. And same thing? Through
`conferences?
` A. Through conferences and -- I
`know him probably a little bit better because
`he's a technology guy, through conferences and
`things like that. But I've never worked with
`him or been funded with him or had close
`collaboration with him.
` Q. What about Craig Markovitz or
`Takeo Kanade? Do you know them?
` A. I don't know Craig Markovitz. I
`know Kanade by reputation only.
` Q. All right. And that ends the
`part of the deposition that's going to be
`common to the two proceedings.
` Q. We're turning to the issue of
`the '411 patent and the associated inter
`partes review.
` Let me start by giving you a
`copy of -- I think you already have this, but
`just so it's handy, a copy of Exhibit 1001,
`the '411 patent itself --
` A. Thank you.
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` Q. -- and also your declaration,
`which is Exhibit 2003.
` A. Thank you.
` Q. Let's start at Paragraph 25 of
`your declaration.
` Actually, no. Let's start with
`the patent itself.
` A. Okay.
` Q. You talk a bit about Figure 2 of
`the patent.
` Do you see that?
` Actually, let's start -- just
`look at Figure 2, if you wouldn't mind.
` A. Yep, I have Figure 2 of the
`patent.
` Q. So this is a flow chart?
` A. That's correct.
` Q. And Steps 40 to 48 you describe
`in your declaration as part of the
`preoperative procedure 50?
` A. Can you point to me in my
`declaration?
` Q. Let's just use the patent.
` In Column 9, beginning at around
`Line 50 -- no, Line 49 -- or 39.
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` A. 39, okay.
` Q. Preoperative procedure.
` A. Preoperative procedure, 50,
`right. They refer to -- yep, 40 to 48, which
`is indicated by 50, yes, the preoperative
`procedure.
` Q. Okay. And then Steps 52 to 56
`are part of 60, which is the intraoperative
`procedure. Right?
` A. I would assume that's so.
` Can we just point to where
`that's --
` Q. I think that's Column 11, Line
`11.
` A. (Reviewing document.)
` The execution of the
`intraoperative procedure 60. Yes, that's
`correct.
` Q. So what is the difference
`between the preoperative and intraoperative?
` A. So the preoperative is the part
`of the procedure that is done before the
`procedure actually begins.
` Sorry? You said difference
`between preoperative and intraoperative.
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`Mako Exhibit 1010 Page 19
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`Page 20
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`Right?
` Q. Yes.
` A. Yeah, preoperative is done --
`the part of the procedure that's done before
`the procedure actually begins.
` And the intraoperative part is
`the part of the procedure that's done in the
`operating room as part of the surgical case.
` Q. So for example, on Column 11
`right after what you just read, it says,
`"During the surgical procedure, the pelvis 76
`of the patient is exposed."
` A. Yes that's correct.
` Q. That would be part of the
`intraoperative procedure?
` A. That would be part of the
`intraoperative procedure.
` Q. Okay. And then further down it
`says, for example, at Line 26, "The
`intraoperative positional data is registered
`with the pelvic model and femur model as shown
`in Figures 10(a) and (b)."
` Is that part of the
`intraoperative procedure as well?
` A. (Reviewing document.)
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`Mako Exhibit 1010 Page 20
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`
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`Page 21
` I'm sorry. I lost the blind
`where we just were.
` That was the 26?
` Q. Talking about registering the --
` A. The 26, right.
` Q. Yeah.
` A. Right. Right. Right. Yeah, it
`says, intraoperatively the pelvic and the
`femur model are registered.
` And that would be part of the
`intraoperative procedure, yes, that
`registration step. Yes.
` Q. Okay. And registration is
`typically performed intraoperatively?
` A. Right. Yeah, registration would
`have to be performed intraoperative.
` Q. At the time the '411 patent was
`filed, was intraoperative biomechanical
`simulation already known?
` MR. BUROKER: Objection to form
`and scope.
` THE WITNESS: Let's see. What
`was the filing date for the '411 patent? So
`what time are we talking about?
`BY MR. KREEGER:
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`Mako Exhibit 1010 Page 21
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`Page 22
`
` Q. '97 or '98.
` A. Okay. And the question is was
`intraoperative biomechanical simulation
`already known?
` No, I don't think that
`intraoperative biomechanical simulation was
`being used then at the time.
` Q. Okay. And what about
`preoperative biomechanical simulation?
` MR. BUROKER: Same objection.
` THE WITNESS: I think there had
`been some research articles on the subject,
`but I'm not sure that it was being used in
`clinical practice anywhere.
`BY MR. KREEGER:
` Q. Are you familiar with the term
`"soft tissue balancing"?
` A. I'm actually not familiar with
`the term "soft tissue balancing."
` Q. All right. Turning to the
`claims of Exhibit 1001, if you could take a
`look at Claim 17, please.
` A. Right. Claim 17. Yeah, I have
`that here.
` Q. That claims refers to something
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`Page 23
`calmed a predetermined range of motion about
`two thirds of the way down the claim.
` Do you see that?
` A. Let's see. It says,
`"Determining an implant position based upon a
`predetermined range of motion and the
`calculated range of motion." Yes.
` Q. And what is the predetermined
`range of motion?
` A. Yeah. I think that is probably
`the range of motion that the clinician would
`like to obtain.
` Q. So that's sort of the desired or
`goal range of motion?
` A. Desired, yeah. The range of
`motion for the procedure.
` Q. And then the claim requires you
`to compare the calculated range of motion to
`the predetermined range of motion?
` A. I guess you could say compare.
`It does say based on predetermined range of
`motion and the calculated range of motion,
`yes.
` Q. And what is the purpose of that?
`Why not just maximize your range of motion?
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` A. It may be that the clinician has
`a certain idea based upon his experience as to
`how he would like to see, you know, the --
`what the desired range of motion is.
` And so that would allow that to
`be taken into account.
` Q. All right. Let's turn to your
`declaration, Paragraph 34.
` A. (Complying.) I'm sorry. I was
`on Page 34. Paragraph 34.
` Q. Paragraph 34.
` A. Yep.
` Q. Here you're taking about the
`'976 patent, the parent patent for the '411.
` Do you recall that?
` A. Right, the '976 is the parent
`patent.
` Q. I have that here for you too if
`you need it.
` A. That would be great. I think I
`have a copy in here.
` Q. Here it is. I'm showing you
`what I guess has not previously been marked.
`It's the '976 patent.
` If it was marked, I don't
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`
`remember.
` MR. BUROKER: I don't think it
`is.
` Do you want to mark it as an
`exhibit?
` MR. KREEGER: Go off the record.
` (Discussion was held off the
`record.)
` - - -
` (Whereupon the document was
`marked, for identification purposes, as
`Exhibit Number 1016.)
` - - -
`BY MR. KREEGER:
` Q. All right. So Dr. Cleary, we
`decided to mark it as an exhibit. It's
`Exhibit 1016.
` A. Yes, I have it.
` Q. This is the '976 patent that
`you're talking about here in Paragraph 34?
` A. Right.
` Q. And here you're talking about a
`patient's joint.
` And you state in your second
`sentence of Paragraph 34, "One of ordinary
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`Page 26
`
`skill in the art would have known in
`February 1997 that a patient's joint can
`include any of a hip joint, knee joint, hand
`and wrist joint, elbow joint, shoulder joint
`and a foot and ankle joint?
` A. Yes. That's correct.
` Q. How many different joints are
`there in the human body?
` A. Gosh, I don't know.
` Q. Hundreds. Right?
` A. There's quite a few, yep.
` Q. So when it referenced a
`patient's joint in the '976 patent, was it
`limited to just the ones you mentioned here or
`do you think it applied to any joint?
` A. I think it could define any
`joint that you could kind of define by bony
`landmarks or that were commonly performed
`orthopedic procedures.
` Q. And can you give me a list of
`all of those?
` A. I don't know if I could give you
`a list of all those, but I think they would
`include the ones listed here.
` Q. Right. I want to know how many
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`
`additional ones there are.
` A. Well, I would have to think
`about that. I guess I can't consult an
`orthopedics or a biomechanics textbook here
`since it's not part of the record.
` Yeah, I couldn't answer that off
`the top of my head.
` Q. Okay. You don't have any
`training in orthopedic surgery, do you?
` A. No, I have no training in
`orthopedic surgery, but I have observed many
`orthopedic procedures and I have worked with
`orthopedic surgeons, if I can add that to my
`statement.
` Q. Please.
` How common was elbow joint
`replacement surgery in 1997 and 1998?
` A. Yeah. I don't know how common
`that was at that time.
` I imagine that the hip and knee
`were the big markets then, and still are.
` Q. You imagine?
` A. The hip and knee were the big
`markets, and still are.
` Q. Do you know how many total elbow
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`replacement surgeries have been performed to
`date?
` A. I do not.
` Q. Do you know of any published
`articles about elbow joint replacement?
` A. I do not.
` Q. In Paragraph 37 of your
`declaration, you state -- and I'm reading from
`the third line from the bottom on Page 21 --
`"Although each joint has a different geometry,
`one of ordinary skill in the art would have
`been able to adapt the discussion of total hip
`replacement surgery provided in the '976
`patent original specification to implantation
`surgeries involving any of these other
`joints."
` A. Yes, that's correct.
` Q. And you indicate that each joint
`has a different geometry. That's how you
`started out that sentence.
` A. Right. Yeah, each joint has a
`different geometry. Right. Right.
` Q. Are there other factors besides
`geometry that would need to be taken into
`account in adapting the hip replacement
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`surgery described in the '976 to perform
`replacements of these other joints?
` A. I'm not exactly sure, but I
`think from a modelling perspective that the
`idea of the rigid body models and the tracking
`could be applied directly to those other
`joints.
` Q. Does it matter whether the joint
`is a weight-bearing joint?
` A. I'm not sure for -- I don't
`think it matters for purposes of tracking the
`motion of the joint.
` Q. Well, the '976 patent is
`involved -- it involves more than just
`tracking the movement. Right?
` A. I would have to review the '976.
` From there I'm talking from a
`tracking and rigid body specification point of
`view.
` Q. Right. But your opinion is
`about what one of ordinary skill in the art
`would have to do to adapt to a discussion of
`total hip replacement surgery to perform
`surgeries on these other joints.
` And I'm asking you whether, if
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`Page 30
`one of skill in the art were attempting to do
`that, would they have to take into account
`whether these other joints were weight-bearing
`joints?
` A. I don't believe they would have
`to take that into account.
` Q. Okay. Would it matter whether
`the implants are mechanically interlocked with
`one another?
` A. Can you tell me what you mean by
`"mechanically interlocked"?
` Q. Well, I'm not an orthopedic
`surgeon.
` A. They're two pieces.
` Q. Well, I mean, for example, a hip
`might be a ball socket; whereas, some of these
`other joints might not be. Correct?
` A. Might not be, correct.
` Q. All right. Let's turn to
`another subject.
` A. Sure.
` Q. In your Paragraph 39, you talk
`about the DiGioia reference.
` A. Yes, I see 39.
` Q. And I have that if you would
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`like to see it.
` A. Yeah, please.
` Q. I'm showing you what's been
`previously marked as Exhibit 1005.
` A. Thank you.
` Q. And on Page 3 of this document
`there is Figure 3.
` Do you see that?
` A. I see Figure 3, yes.
` Q. There's something there called a
`preoperative planner?
` A. There is a preoperative planner.
` Q. Is that a software module?
` A. Yeah, that would be implemented
`software. Yes.
` Q. And below that there is
`something called a range of motion simulator?
` A. Yes, that's correct.
` Q. Is that also a software module?
` A. That would also be a software
`module.
` Q. Okay. And there are arrows
`going between those two modules. Correct?
` A. That is correct.
` Q. And doesn't that mean that the
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`Page 32
`two software modules are communicating with
`one another?
` A. It depends upon, I guess, what
`you mean by "communicating."
` They certainly may pass some
`information back and forth, but it doesn't
`really say at what rate.
` Q. In your declaration you talk
`about something you refer to as a
`semi-autonomous system, which you contrast
`with an autonomous system.
` A. Yeah. Could yo
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