IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
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`1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,361,156 B2
`Issue Date: January 29, 2013
`Case IPR2013-00506
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,187,334 B2
`Issue Date: May 29, 2012
`Case IPR2013-00507
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,187,334 B2
`Issue Date: May 29, 2012
`Case IPR2013-00508
`---------------------------------------------------
` Examination Under Oath of HANSEN A. YUAN, M.D.,
` held at 211 West Jefferson Street, Suite 21,
` Syracuse, New York, on August 22, 2014, before
` MARITA PETRERA, Registered Professional Reporter,
` and Notary Public in and for the State of New York.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,361,156 B2
`Issue Date: January 29, 2013
`Case IPR2013-00506
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,187,334 B2
`Issue Date: May 29, 2012
`Case IPR2013-00507
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,187,334 B2
`Issue Date: May 29, 2012
`Case IPR2013-00508
`---------------------------------------------------
` Examination Under Oath of HANSEN A. YUAN, M.D.,
` held at 211 West Jefferson Street, Suite 21,
` Syracuse, New York, on August 22, 2014, before
` MARITA PETRERA, Registered Professional Reporter,
` and Notary Public in and for the State of New York.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`28
`probably over 60 percent of total fusions, 60 to
`70 percent.
` Q. So 60 percent to 70 percent of the
`60 percent of your total cases?
` A. Right.
` MR. AMON: Dr. Yuan, please let
` Mr. Schwartz finish his question.
` THE WITNESS: Sorry.
` Q. Okay. Sir, and then of those lumbar
`cases, could you break out anterior procedures
`versus posterior procedures?
` A. There were period of time that we did
`anterior surgery and the anterior surgery that we did
`are actually relatively few. We did a
`laparoscopically, we did open, so the majority of the
`lumbar cases, I would say over 80, 85 percent, either
`going to be posterior, posterolateral. And these all
`happen over a period, so in the early, early days, we
`would have done a lot more anterior -- posterior
`because we didn't have any other, and then for a
`short period of time we went ahead and did a lot of
`anterior, and then towards the end with the
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`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`29
`improvement of the modern interbody spacers, cages,
`we shifted again to posterior and posterolateral and
`then of course the lateral approaches.
` Q. When did you first start doing lateral
`approaches, sir?
` MR. AMON: Objection; vague.
` A. Lateral approaches, for what condition?
` Q. Well, any lateral approach using an
`intervertebral implant for any condition.
` A. I did lateral approaches as early as 1980s.
` Q. 19?
` A. 80s.
` Q. 1980s.
` A. And that included using cages, but those
`are mostly for fractures, and most of those cases are
`in the thoracic, and in the thoracolumbar junction.
` Q. Could you explain what the thoracal lumbar
`junction is?
` A. Between the thoracic which is the ones with
`the ribs and fairly stable and so between the
`thoracic transiting to the lumbar which is more
`flexible, so most of the injuries that's going to
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`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`30
`occur most commonly is between the thoracic and the
`lumbar. So it's pretty much like T11, T12, L1, L2.
` Q. Okay.
` A. And maybe L3.
` Q. Did you do any vertebral body
`replacements?
` A. Yes.
` Q. Did you do any of the vertebral body
`replacements laterally?
` A. Oh, yes.
` Q. The way you said that, "oh, yes," does
`that suggest that that was routine for you to do
`vertebral body replacements laterally?
` A. It isn't routine, because most of the cases
`for a period of time that we did vertebral
`replacement, for example, like in the TB, infections,
`and certainly in certain fractures, but most of the
`fractures we still treat posteriorly.
` Q. You did do some vertebral body
`replacements laterally?
` A. Yes.
` Q. Did you do any anteriorly, from an
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`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`31
`anterior approach?
` A. Vertebral body replacement, is that what
`you're referring to?
` Q. Um-hmm.
` A. I'm trying to, I'm trying to think the
`term. When you make an exposure, if you are going to
`go to replace a whole vertebral body, you can say
`that you're using a lateral incision because in those
`days not so-called minimally invasive, we use a long
`incision. So when you use a long incision, you are
`literally able to approach the spine direct
`anteriorly, so this is why to be specific to answer
`you, I, when I say we are using a lateral approach,
`we are using a lateral incision because it is an open
`procedure and we could replace a vertebral body
`depending on the anatomy of where the major blood
`vessels are, either putting the implant lateral or
`putting an implant in anteriorly.
` Q. Okay. What about an oblique approach,
`sir, did you do any vertebral body replacements
`through what's referred to as an oblique approach?
` A. You tell me what you mean by an oblique.
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`Yuan, M.D., Hansen A.
`August 22, 2014
`
`32
` Q. Maybe I should switch that around. Do you
`have an understanding of what an oblique approach
`is, sir?
` A. Standing by itself, an oblique just means
`you're going at an angle. I don't understand the
`question.
` Q. Sure. Sir, we talked about vertebral body
`replacements going in laterally, and we talked about
`vertebral body replacements going in anteriorly,
`correct. So now I'm asking about variations from
`the lateral and anterior, and what I'm asking is, is
`there something that is angularly different than
`lateral and anterior where you might go in between
`those two? Perhaps I'll rephrase. Strike the
`question. And unfortunately we don't have a video,
`so I can't capture the precision of this.
` But anteriorly, generally we are talking
`about coming in through the belly, right, sir,
`coming in from the surgeon's perspective and, well,
`what I'm pointing to towards the belly, towards,
`towards the spine, correct, sir?
` A. (Nodding.)
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`Yuan, M.D., Hansen A.
`August 22, 2014
`
`33
` Q. And then laterally, generally we are
`talking about from the side of the patient going in
`at an angle towards the side directly into the
`vertebra, or generally, correct, sir?
` A. (Nodding.)
` Q. So for an oblique, I apologize again for
`not having this down.
` A. Go ahead.
` Q. Would be somewhere in between where my
`hand and my pen are, so at an angle something like
`this?
` A. You are still referring, so let me qualify.
`You are still referring to in the thoracolumbar
`junction?
` Q. Correct, sir.
` A. Okay. And the thoracolumbar junction, when
`you are saying going in obliquely, we don't use a
`term because of the, once you open with a long
`incision, you can put the implant in lateral,
`anterior, slightly off anterior, and in adjusting it,
`you can do all of those.
` Q. Okay.
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`Yuan, M.D., Hansen A.
`August 22, 2014
`
`34
` A. So I was a little puzzled why you would ask
`me to describe that, in those levels, an oblique.
`Because I'm, I have the whole area open.
` Q. Okay.
` A. So the implant can go in slightly at an
`angle, direct lateral or anterior.
` Q. So something that would be off an angle
`from the lateral or anterior, you would just
`generally categorize as one of those two, lateral or
`anterior as opposed to calling it an oblique?
` MR. AMON: Objection;
` mischaracterizes Dr. Yuan's testimony.
` A. We have not used the word oblique, so
`that's, excuse me, so we will say you are making a
`lateral approach and then you have the ability to see
`both lateral and anterior, depending on the visceral
`structures, and how the peritoneum falls away,
`whether it is L2 near where the kidney is, you
`definitely cannot go anterior laterally. So consider
`the kidney is, you are going to go laterally. And
`then when you get below the kidney, you going to go
`anterior. So in that area, there is visceral
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`Yuan, M.D., Hansen A.
`August 22, 2014
`
`35
`structures, particularly the thoracolumbar junction,
`so we have never used the term oblique approach.
` Q. Okay.
` A. But you are looking at the whole thing.
` Q. Maybe I can do this by diagrams just so we
`can actually have a record. Well, we'll get to
`that. There will come a document that will perhaps
`help us.
` Getting back to your CV, sir,
`Exhibit 2021, there's a couple of entries that I'd
`like to talk about. If you could turn to Page 27 of
`that document, I'll wait -- okay. Do you see, sir,
`the entry for Thai Orthopedic Association.
` A. Yes.
` Q. And within that is the One Year Follow Up
`on Experiences With BAK in Posterior Interbody and
`Anterior Interbody Fusion For Degenerative Disc and
`Low Grade Degenerative Spondylolisthesis of the
`Lumbar Spine. Do you see that entry, sir?
` A. Yes.
` Q. Can you explain to me, if you recall, what
`that one year follow-up was describing? I realize
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`Yuan, M.D., Hansen A.
`August 22, 2014
`
`36
`it's 20 years ago, sir, so if you don't recall I
`appreciate that.
` A. That's okay. Very simple. I can cover
`that topic.
` As I was testifying before during your
`questioning of what cases, when we did them -- this
`is back in 1994 -- so in 1994 there was a period of
`time as I mentioned we did some anterior approaches.
` So in this case here, we are using the
`either posterior which is the very popular described
`mostly by my neurosurgical colleagues who are
`comfortable doing posterior interbodies, and we are
`kind of developing and pioneering an approach of
`doing laparoscopic anterior.
` So what the caption here reads is a
`minimally invasive, so is no longer an open
`procedure. We are making stab wounds in different
`location and once we make the stab wounds, we
`actually -- we are filling the abdominal cavity with
`air or carbon dioxide. So we insufflating the
`abdominal cavity and then what that does is allow the
`structures to be able to be moved aside. And then we
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`Yuan, M.D., Hansen A.
`August 22, 2014
`
`41
`for one or the other.
` Q. Okay, sir. If you would, I'd like to move
`to another entry. This is on Page 33 of your CV.
`It's the North American Spine Society entry. And
`specifically, sir, do you see that entry?
` A. Yes.
` Q. Specifically, sir, I'm interested in the
`Posterior Lumbar Interbody Fusion With Single
`Posterolateral Threaded Cage Insertion.
` Did I read that correctly?
` A. Yes.
` Q. Can you describe what that was about?
` A. I'm sorry it's taking time.
` Q. Sure, no problem.
` A. I'm reading. I haven't looked at this in
`long time. So I'm thinking back, as you say 1997.
`Northern American Spine we have several papers.
` Q. Okay.
` A. And so I train a lot of fellows, so each
`fellow in the laboratory will be doing different
`studies. So one of the studies, so this here is
`speaking of a cadaver study. It's a cadaver study.
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`Yuan, M.D., Hansen A.
`August 22, 2014
`
`42
`Why I say it's a cadaver study is because we are
`trying to evaluate how a single posterolateral cage
`as far as allowing us to know the stability of the
`segment after it's implanted. So by going in here we
`are testing how instead of using two cages routinely,
`we are using only one cage. And we are also
`evaluating how this one cage will distract and how
`the dynamics and the stability will be on different
`testings.
` Q. Now, when you say posterior lateral cage,
`I think was the word you used, what do you mean by
`that?
` A. It's the same cage that we are talking
`about, is like the -- again, this is in the same
`period that we are doing the BAK, and so we are using
`a single BAK cage.
` Q. Do you recall if it was longer than the
`anterior or posterior cage?
` A. The BAK cage has a series of sizes. The
`BAK cage sizes generally and here, I don't have the
`document in front of me to let me know exactly, I'm
`just doing this all by recall, so it's an estimate.
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`Yuan, M.D., Hansen A.
`August 22, 2014
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`43
`I would say the longest cage probably is
`28 millimeters, okay. That's what I can recall, was
`28 millimeters. So if it was 28-millimeter cage we
`are using here, we are putting one cage from
`posterolateral angle to study the mechanical
`stability and ability to distract a segment.
` When you have like spondylolisthesis,
`meaning the spine is slightly slipped because the
`disc material has settled and the facet joints are
`worn a little bit to allow the slip, so if you go to
`the front and, then the spine is so-called little bit
`kyphotic, tilted to the front, if you distract it and
`actually open the space up and you also somewhat
`reduce the slippage, this is we are talking about is
`really as we say here is a degenerative
`spondylolisthesis, not isthmic, isthmic meaning,
`meaning a crack in the bone along a slip, but
`degenerative meaning just a wear and therefore
`settling.
` Q. Now, you mentioned the posterior lateral
`angle. What is that referring to?
` A. You're going through a transforaminal
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`August 22, 2014
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`44
`approach.
` Q. So you're coming in from the posterior but
`you're going in diagonally across the space?
` A. Correct.
` Q. And you refer to that as posterior
`lateral?
` A. That's correct.
` Q. Okay. Sir, you mentioned that you
`distract and open the space up. About how much
`would you open the space up?
` A. That's a very important comment, because
`once a disc is degenerated particularly from the
`posterior approach or posterolateral approach, you
`can only distract it whatever the ligaments or the
`annular ligaments will allow. You don't have the
`ability of putting in a spreader and jacking it up
`like a jack.
` So what, how we do this is by putting in a
`debrider so you prepare the disc space by cleaning it
`out, and then you use a smaller size bore of a drill
`to drill the space and when you drill the space you
`actually remove bone from both inferior end plate of
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`Yuan, M.D., Hansen A.
`August 22, 2014
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`45
`the level above to the superior end plate of the
`level below, so there's a smaller bore drill, and
`then you put in your cage.
` The front of the cage slightly tapered, so
`the slightly tapered cage will allow you to purchase
`and as it purchase it will slowly raise the level as
`it's implanted. So that's how you distract. So you
`don't distract very much. You distract probably a
`couple millimeters at the most.
` Q. Okay. Would that be a couple millimeters
`on both sides or a couple millimeters in total?
` A. Pretty much in total.
` Q. Okay. Sir, if you would turn to Page 34
`in your CV. You see the entry there for
`January 24th to the 27th of 1998, that begins Spinal
`Surgery dot dot dot?
` A. Yes.
` Q. Specifically my question is with regard to
`the portion dealing with Posterior Lateral Interbody
`Approach With BAK Cage and Facet Fixation. Do
`you see that, sir?
` A. Yes.
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`46
` Q. Perhaps as a shortcut, is that basically
`the same procedure you were just talking about with
`regard to NASS or is there something different?
` A. It is something different.
` Q. Okay. I'm trying to avoid duplication,
`but what were the differences?
` A. The NASS was a presentation of anatomical
`cadaver study. This thing here is the, this
`paragraph really speak about current and innovative
`theories and technique. So it is not, it's not the
`standard of care, it's not what is generally used.
`It is really speaking about either, either anatomical
`studies or small clinical studies, small means small
`number.
` So the idea here is, for example, if you
`look at the whole paragraph to make sense, we're
`using anterior thoracolumbar plates for trauma.
` Q. Okay.
` A. This is a 1998. There's a major question
`whether that is stable after you put in a vertebral
`body replacement, and because the biomechanics of
`this is not as stable as using pedicle screws. So we
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`47
`are using anterior thoracolumbar plates and again
`here is a current and innovative theory and
`techniques that we are talking about.
` So with that the posterolateral in the body
`approach using the BAK cage, a single cage, and then
`once you put the cage in, I shared a little bit with
`you before to say once you distract a segment, that
`segment is a little bit unstable because it has a
`little bit of a slippage or listhesis, and once you
`distract you like to hold that position, so then you
`are using the facet joints to fix the facet joints.
`So it's an addition of adding fixation to that
`segment to give it more stability.
` Q. Okay.
` A. So important thing here is really, again
`the topic goes on to talk about anterior load
`sharing. And you know, it's understanding the
`biomechanics. So this is again a biomechanical study
`and describing these techniques and the testing
`results.
` Q. And the posterolateral interbody approach
`with the BAK cage that's being studied here, is that
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`48
`same single BAK put in at a diagonal?
` A. Yes.
` Q. Okay. Sir, and then further on down that
`same page, you see the Ray TFC Symposium?
` A. Yes, sir.
` Q. And the entry that says "My experience
`with BAK open anterior/posterior laparoscopic and
`transforaminal approach with adjunctive fixation and
`lateral approach using minimally incisional
`approach."
` A. Yes.
` Q. I read that correctly?
` A. That's correct.
` Q. Can you describe what that is and if it's
`the same as something you've already said, you can
`just tell me that.
` A. We've been doing BAKs at that time in the
`beginning all posterior. And then we begin to
`develop the anterior approach, either open or
`laparoscopic. And it's an extension of what we talk
`about using the single cage lateral --
`transforaminally and then begin to start putting in a
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`49
`few of these cages laterally. All of this is done
`pretty much in the upper lumbar spine, thoracolumbar
`junction, upper lumbar spine. The reason for us
`doing these studies is to assess can we go to a
`minimal incisional approach.
` At this particular time, actually Dr. Paul
`McAfee was my fellow -- actually was my resident --
`and so we were doing cases in the laboratory looking
`at the biomechanical and then the, we begin to do a
`few cases clinically. But none of this went on to
`marketing. The reason why is the specifics of that
`cage design, because it has to drill out the end
`plates and then putting in a small cage, even though
`with adjunctive fixation these things collapsed. So
`none of it was developed, none of it went to market.
`Both the mechanical testing results tells us the
`adjunctive fixation might make it work, but
`clinically Paul and I have done a couple lateral
`approach; didn't work. And neither did the
`transforaminal approach.
` Q. Are you done, sir? I don't want to
`interrupt.
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`50
` The couple lateral that you did with Paul,
`were those in human patients?
` A. Yes.
` Q. So living people?
` A. Yes.
` Q. And when you say it didn't work, what do
`you mean by that? They didn't die, did they?
` A. No. Patient didn't die. But spine
`actually we tried to correct it into lordotic posture
`and then as I said, the, the properties are not
`correct because of the end plates being removed to
`use those cages even though they were big cages, and
`the length of them we only had 28s, so those cages
`actually subsided and then the spine basically
`resumed the deformity, which is kyphosis. So a
`kyphotic spine is not a good end result. The
`patients didn't die. But these are done under
`individual hospital IRB approval.
` Q. So the IRB communicated to you that it was
`okay to go ahead with the procedure?
` A. It's all approved and documented. The
`patients' permission and signature and all of this is
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`www.hendersonlegalservices.com
`
`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`51
`notified to the FDA.
` Q. So at least you and Dr. McAfee thought it
`would be safe to do it with a patient?
` A. No. We've done mechanical testing, the
`mechanical testing results indicated to us that
`mechanically we're able to achieve the stability, but
`on the clinical usage of it over time, it didn't
`prove out. So many, many, many things that as we say
`innovative and technical, you go through testing, it
`is safe to use on a patient, but when you do it on a
`patient the outcome is not 100 percent.
` So the outcome in our mind listing here is
`something we should not propagate.
` Q. But before you put it in the patient you
`thought it was safe to do what you ultimately did,
`correct, sir?
` A. It is safe.
` Q. Okay. It is safe?
` A. But it's not efficacious.
` Q. And when you -- before you did the
`procedure, you thought it was reasonable to proceed
`with the procedure, correct?
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`www.hendersonlegalservices.com
`
`
`
`IPR2013-00506; IPR2013-00507; IPR2013-508
`Yuan, M.D., Hansen A.
`August 22, 2014
`
`62
` A. Transforaminal is posterolateral approach.
` Q. You would describe that then as a subset
`of a posterior lateral approach, or a type of
`posterior lateral approach? Strike that.
` Would you describe the transforaminal as a
`type of posterior lateral approach?
` A. The transforaminal is a posterolateral
`approach.
` Q. Okay.
` A. As you probably try to broad
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