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`Dr. Paul McAfee - 12/6/2013
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` NUVASIVE, INC.
` Petitioner
` v.
` WARSAW ORTHOPEDIC, INC.
` Patent Owner
` Patent Number: 8,251,997 B2
` Issue Date: August 28, 2012
` Title: METHOD FOR INSERTING AN ARTIFICIAL
` IMPLANT BETWEEN TWO ADJACENT VERTEBRAE
` ALONG A CORONAL PLANE
` Case IPR2013-00206
` and
` Case IPR2013-00208
`
` The deposition of PAUL MCAFEE, M.D., M.B.A.
`was held on Friday, December 6, 2013, commencing at
`3:50 p.m., at 20 South Charles Street, Suite 901,
`Baltimore, Maryland 21201, before Ronald E. Bennett,
`Notary Public.
`Job No: 68459
`
`TSG Reporting - Worldwide (877)702-9580
`
`WARSAW2039
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
`
`Page 1
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`Dr. Paul McAfee - 12/6/2013
`
`Page 1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` NUVASIVE, INC.
` Petitioner
` v.
` WARSAW ORTHOPEDIC, INC.
` Patent Owner
` Patent Number: 8,251,997 B2
` Issue Date: August 28, 2012
` Title: METHOD FOR INSERTING AN ARTIFICIAL
` IMPLANT BETWEEN TWO ADJACENT VERTEBRAE
` ALONG A CORONAL PLANE
` Case IPR2013-00206
` and
` Case IPR2013-00208
`
` The deposition of PAUL MCAFEE, M.D., M.B.A.
`was held on Friday, December 6, 2013, commencing at
`3:50 p.m., at 20 South Charles Street, Suite 901,
`Baltimore, Maryland 21201, before Ronald E. Bennett,
`Notary Public.
`Job No: 68459
`
`TSG Reporting - Worldwide (877)702-9580
`
`WARSAW2039
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
`
`Page 1
`
`
`
`Dr. Paul McAfee - 12/6/2013
`
`Page 2
`
`APPEARANCES:
`
` ON BEHALF OF NUVASIVE, INC.:
` TODD MILLER, ESQUIRE
` Fish & Richardson
` 12390 El Camino Real
` San Diego, California 92130
`
` - AND -
`
` STEPHEN SCHAEFER, ESQUIRE
` Fish & Richardson
` 3200 RBC Plaza
` 60 South Sixth Street
` Minneapolis, Minnesota 55402
`
`APPEARANCES (Continued on the Next Page)
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`Dr. Paul McAfee - 12/6/2013
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`Page 3
`
` PAUL MCAFEE, M.D., M.B.A.
`
`APPEARANCES CONTINUED:
`
` ON BEHALF OF WARSAW ORTHOPEDIC, INC.:
` LUKE DAUCHOT, ESQUIRE
` STEVEN PAPAZIAN, ESQUIRE
` NIMALKA WICKRAMASEKERA, ESQUIRE
` Kirkland & Ellis
` 333 South Hope Street
` Los Angeles, California 90071
`
`ALSO PRESENT: James Garrett, Esquire, VP NuVasive
` Jonathan Spangler, Esquire, VP NuVasive
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`
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`Dr. Paul McAfee - 12/6/2013
`
`Page 4
`
` INDEX
` Deposition of PAUL McAFEE, M.D., M.B.A.
` December 6, 2013
`
`Examination By: Page
`Mr. Dauchot 5
`
`Exhibit No. Marked
`Exhibit 2028 Trial Testimony 46
`Exhibit 2029 Article 50
`Exhibit 2030 Article 50
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`Dr. Paul McAfee - 12/6/2013
`
`Page 24
` A. I don't remember, for example, being on a
`Board of Directors or -- not within the last five
`years, at least. I'll correct that. In the early
`forms of NuVasive, they had a meeting called Spine
`Evolution Nucleus, and I participated in those
`meetings, which I would describe as a think tank. But
`I don't regard that as being a formal position in the
`company.
` Q. When did that end?
` A. In the early 2000s.
` Q. I want to shift gears and touch on the
`subject of fusions in general. You'll agree with me
`that there are many types of spinal fusions?
` A. Yes.
` Q. And you will agree with me that a fusion is
`a procedure designed to correct a pathology with the
`vertebra or the intervertebral space?
` A. It can be.
` Q. What else can it be?
` A. It could correct a problem within the
`vertebrae itself.
` Q. And you're thinking about a corpectomy or
`partial corpectomy?
` A. Yes, sir.
` Q. Beyond what we have covered here, do you
`
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`Dr. Paul McAfee - 12/6/2013
`
`Page 26
` Q. Right. Just for clarification let's look
`at Page 5 of 38, right, that Declaration? Is that
`where you are?
` A. Page 5 of 208.
` Q. Okay. So Page 5 of 41 submitted in the 208
`proceeding?
` A. Yes, sir.
` Q. Okay. And you'll agree with me that fusion
`procedures exist with respect to just the posterior
`part of the vertebral body, correct?
` A. They can do that, yes.
` Q. And that would, for example, be a fusion of
`the spinal processes, right?
` A. Yes.
` Q. And those fusions don't involve the
`implantation of an implant, correct?
` A. No.
` Q. Am I correct?
` A. No.
` Q. They do involve the implantation of an
`implant?
` A. They certainly could.
` Q. They could. But my question is, do they
`necessarily involve that?
` A. A spine fusion anywhere can be with or
`
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`without an implant.
` Q. Okay. I want to shift gears and focus for
`a minute on the anatomy of the nerves. If we look at
`the top part of the spinal column, we have a spinal
`cord that runs up and down the back of the vertebral
`column, right?
` A. No.
` Q. Okay. We do have a spinal cord, right?
` A. Yes.
` Q. Where does the spinal cord run?
` A. It runs within the spinal column. It runs
`directly posterior to the middle column.
` Q. Up and down, right?
` A. Correct.
` Q. Now at some point -- we call that,
`depending on what level, we call that the dural sac?
` MR. MILLER: Objection, form.
` THE WITNESS: No.
`BY MR. DAUCHOT:
` Q. Okay. What is the dural sac?
` A. The dural sac is the covering or menages
`around the spinal cord and around the nerve roots.
` Q. Okay. At some point the dural sac -- you
`don't have a dural sac around the spinal nerves that
`run up and down the column, correct?
`
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`Dr. Paul McAfee - 12/6/2013
`
`Page 37
` Q. Okay. Certainly, when we are talking about
`general background along these lines, it applies to
`both, right?
` A. My previous answer stands.
` Q. Okay. So it's your testimony, just so I'm
`clear, and the Board understands, that when we are
`talking, for example, I want to make sure the Board is
`clear about your position, when we are talking about
`Page 7 in the diagram you have here.
` And I'm going -- this diagram that you have
`on Page 7 of 41 of the 208 report, that your answers
`with respect to that diagram will be different from
`those on Page 7 of 38 in your 206 report?
` MR. MILLER: Objection, form. Counsel, Dr.
`McAfee --
` MR. DAUCHOT: You are not allowed to make
`speaking objections under the Rules. I'm happy to call
`the Court back.
` MR. MILLER: I'm going to make a
`stipulation. Where the text is the same, then what you
`are trying to do is fine.
` MR. DAUCHOT: Terrific. I thought you were
`lodging an objection. It's a little antsy.
`BY MR. DAUCHOT:
` Q. Let's go to Page 7 of 41, which is the 208
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`Page 38
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`report. You indicate a number of approaches to the,
`surgical approaches to the spine, as part of your
`discussion in column, in Paragraph 10, correct?
` A. Yes.
` Q. You note, as illustrated below, the various
`approaches that may be taken to the anterior column of
`the spine include posterior, postero-lateral, far
`direct lateral, antero-lateral and anterior. Do you
`see that?
` A. Yes.
` Q. Okay. So, when one refers to the term
`"lateral" generally, depending on the particular
`circumstances and context, it could mean
`antero-lateral, direct lateral or postero-lateral,
`correct?
` MR. MILLER: Objection, form.
` THE WITNESS: It's a nonspecific term,
`correct.
`BY MR. DAUCHOT:
` Q. And you are also aware of physicians who
`use persons in the art, skilled in the art and the
`relevant art here who use the term "lateral" to
`describe something that is adjacent to the midline,
`lateral to the midline of the vertebral body, right?
` MR. MILLER: Objection, form.
`
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`Dr. Paul McAfee - 12/6/2013
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`Page 39
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` THE WITNESS: Yes.
`BY MR. DAUCHOT:
` Q. I want to focus on the claim language
`that's contained in a number of the claims of the '997
`Patent, quote, being sized to occupy substantially the
`full transverse width of the vertebral bodies of two
`adjacent vertebra.
` Are you familiar with that language?
` A. Yes. But I would like to take a look at
`the patent.
` Q. Okay. We are handing you what has been
`NuVasive 1002. That is a copy of the '997 Patent.
` A. Can you tell me where you are reading from?
` Q. Sure. If we look at Claim 1, for example,
`and let me just refer to the column. Column 23,
`Line 26 and 27 and part of 28.
` A. I'm sorry. Column 22.
` Q. Column 23. Lines 26 through 28.
` A. Yes, I have that.
` Q. Okay. Now in your Declaration -- we can go
`back to -- Dr. McAfee, how do you construe that term or
`that phrase for purposes of your opinions in this
`matter?
` A. The phrase being sized to occupy the full
`transverse width. For direction I look at Figure 23,
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`Dr. Paul McAfee - 12/6/2013
`
`Page 40
`which I have also listed on Page 11 of my Declaration.
`And I construe that to be representative within the
`patent. So I construe that to mean a device which is
`at least 73 percent of the full transverse width of one
`of the adjacent vertebral bodies.
` Q. Okay. You said: Full transverse width.
`In Column 23, Lines 26 and 30, say: Substantially, the
`full transverse width. Do you see that?
` A. My answer refers to the phrase the -- my
`answer refers to the phrase, sized to occupy
`substantially the full transverse width of the
`vertebral bodies of the two adjacent vertebrae.
` Q. Okay. And you defined that to be
`73 percent, based on the example shown in Figure 23?
` A. Correct.
` Q. And the measurements you took with respect
`thereto?
` A. Correct. That would be the best mode.
` Q. What do you mean, "that would be the best
`mode"?
` A. It would be the best mode or representation
`of the claim language.
` Q. Why is that the best representation of the
`claim language?
` A. Because it's my understanding that the
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`Page 41
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`figures are a demonstration of what's listed in the
`patent claims.
` Q. That's your understanding?
` A. With regard to this phrase, yes.
` Q. Okay. Now any other grounds for believing
`that substantially the full width is 73 percent?
` MR. MILLER: Objection, form.
` THE WITNESS: No.
`BY MR. DAUCHOT:
` Q. Okay. Can we go -- let's shift gears and
`go to the last column of the patent, which is Column
`28. You with me?
` A. I'm in Column 28.
` Q. Okay. Good. I'm directing your attention
`to Line 8. The length of said implant being sized to
`occupy the full transverse width. Do you see that?
` A. Yes, sir.
` Q. You see that this is not modified by
`substantial. See that?
` A. Yes.
` Q. Okay. Now how do you read that phrase?
` A. It says: The length of said implant being
`sized to occupy the full transverse width of the
`vertebral bodies of the two adjacent vertebrae. The
`length of said implant being greater than the depth of
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`the disc space.
` So that means the implant has to be longer
`than the depths of the disc space, but it's sized to
`occupy the full transverse width of the vertebral
`bodies.
` Q. Okay. And do you read "full transverse
`width" to be anything other than the full transverse
`width of the vertebral body?
` A. No.
` Q. You'll agree with me that full transverse
`width doesn't mean 73 percent, or it wouldn't be full,
`correct?
` A. That's correct.
` Q. Let's shift gears and focus for a moment on
`the Michelson '247 Patent. And that is marked NuVasive
`1008. Are you familiar with this reference?
` A. Yes, sir.
` Q. You'll agree with me that the Michelson
`'247 Patent does not disclose a direct lateral approach
`to the spine, correct?
` A. That's correct. Not within the four
`corners of the document.
` Q. In fact, the only specific approach
`referenced in the '247 Patent is a posterior approach,
`correct?
`
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`Page 43
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` A. Yes, I believe that's correct.
` Q. You'll agree with me, Dr. McAfee, that the
`insertion of an implant posteriorly into the
`intervertebral space carries certain risks that you may
`not have with other approaches to implant an implant to
`the intervertebral space, correct?
` A. Correct.
` Q. And one of the risks associated with the
`posterior implantation of an implant is damage to the
`spinal nerves running up and down the column, right?
` A. Yes.
` Q. And another risk with a posterior to
`anterior insertion is that, as the implant is being
`pressed towards an anterior or in an anterior
`direction, one needs to be very careful about not
`interfering with the blood vessels that are situated to
`the front of the vertebra, correct?
` A. Yes.
` Q. And in placing an implant into the space
`from a posterior to anterior direction, one needs to be
`careful that there is no risk after the procedure of
`the implant either migrating anteriorly towards the
`vessels or migrating backwards towards the nerves
`running up and down the back of the vertebra, correct?
` A. Those are risks, yes.
`
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`
`Page 44
` Q. Now you'll agree with me that illustrations
`in a patent are not always representative of true
`anatomy. Fair enough?
` A. Yes.
` Q. And in understanding the teachings of a
`patent, you certainly wouldn't -- a person of ordinary
`skill in the art certainly wouldn't assume that the
`illustrations are, in fact, dimensionally speaking, and
`otherwise, true representations of the actual anatomy,
`correct?
` MR. MILLER: Objection, form.
` THE WITNESS: I would have to say that they
`should attempt to be representative, but they are not
`necessarily a line-to-line, as far as detail.
`BY MR. DAUCHOT:
` Q. And so as a person of ordinary skill in the
`art trying to understand the teachings isn't going to
`rely exclusively on the illustrations, correct?
` A. That is correct.
` MR. MILLER: Objection, form.
` THE WITNESS: That's correct. They
`wouldn't only base their opinions or their
`understandings on the diagrams.
`BY MR. DAUCHOT:
` Q. Okay. Or assume at face value that the
`
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`diagrams are, in fact, accurate from an anatomical
`perspective, correct?
` MR. MILLER: Object, form.
` THE WITNESS: I would agree with that.
`BY MR. DAUCHOT:
` Q. Is there anything in the '247 Patent that
`actually states, and I'm, in writing here, that an
`implant inserted from an anterior to posterior
`direction should, in fact, span as much of the length
`from an anterior to posterior direction of the
`intervertebral space as possible?
` A. I'm sorry. I didn't understand the
`question.
` (The reporter read back as requested.)
` THE WITNESS: I agree the patent does not
`state that.
`BY MR. DAUCHOT:
` Q. Let's shift gears to general anatomical
`propositions again, Dr. McAfee.
` Dr. McAfee, I'm going to hand you a
`document that's been marked 2028 for purposes of the
`206 proceeding and 2029 for purposes of the 208
`proceeding.
` And it's trial testimony that was given
`during the trial of the NuVasive's infringement of the
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` MR. MILLER: Same objection.
` THE WITNESS: Yes, I see that.
`BY MR. DAUCHOT:
` Q. So he sees the apophyseal ring and the end
`plate as two different features, correct? Apparently,
`given his testimony, what we are reading here?
` MR. MILLER: Objection, form.
` THE WITNESS: Taken to itself this specific
`statement would be that the apophyseal ring and
`cortical bone are parts of the end plate. That's what
`I believe.
`BY MR. DAUCHOT:
` Q. He says: The cortical bone on the
`periphery is the apophyseal ring, not the end plate.
` MR. MILLER: Objection, form. Also, I'll
`note for the record that the document is hearsay. Go
`ahead and answer the question.
` THE WITNESS: The most accurate answer I
`can give is that the apophyseal ring is confluent with
`the cortical bone on the periphery.
`BY MR. DAUCHOT:
` Q. Doctor, that's not my question. My
`question is as follows. If we read what Dr. Brantigan
`said here under oath at trial, okay, is it fair, from
`this reading, to take away that Dr. Brantigan considers
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`Page 49
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`the end plate and the apophyseal ring to be two
`distinct structures?
` MR. MILLER: Objection, form.
` THE WITNESS: And I would say that in some
`cases, Dr. Brantigan is correct.
`BY MR. DAUCHOT:
` Q. Okay. Now this is the same Dr. Brantigan
`who is the inventor on the '327 Patent, correct?
` A. Correct.
` Q. You testified that the end plate -- at some
`point the end plate is confluent with the apophyseal
`ring, right?
` A. What I said was, that the hard cortical
`bone is confluent with the apophyseal ring in most
`circumstances in adults.
` Q. Okay. So the hard cortical bone is part of
`the end plate and at a certain point that becomes
`confluent with the apophyseal ring, right?
` A. Correct.
` Q. Okay. And then at some point, as you get
`closer to the edge of the vertebra, it's all apophyseal
`ring?
` MR. MILLER: Objection, form.
` THE WITNESS: That's correct.
`BY MR. DAUCHOT:
`
`TSG Reporting - Worldwide (877)702-9580
`
`Page 18
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`Dr. Paul McAfee - 12/6/2013
`
`Page 50
` Q. Now on the same page of the trial testimony
`I asked the following of Dr. Brantigan on Page 1520.
`Question: You'll agree with me that capillaries do not
`grow out of the apophyseal ring along the perimeter of
`the vertebral body; am I correct?
` And his answer was: You are correct.
` Do you see that?
` A. Yes.
` Q. Do you agree with him?
` A. Yes.
` Q. I'm going to hand you what would be
`marked -- we're going to shift to another exhibit here,
`Deposition Exhibit 2029 for purposes of the 206
`proceeding and 2030 for purposes of the 208 proceeding.
` (McAfee Exhibit 2029-2030 marked for
`purposes of identification.)
`BY MR. DAUCHOT:
` Q. This is an article that addresses a
`revision procedure for a NuVasive implant inserted
`through an XLIF, initially inserted through an XLIF
`process where the implant had migrated and so the
`implant needed to be removed.
` Let me start off with this question, Dr.
`McAfee. You are familiar with the XLIF procedure at
`NuVasive?
`
`TSG Reporting - Worldwide (877)702-9580
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`Page 19
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`Dr. Paul McAfee - 12/6/2013
`
`Page 52
`not inserted along the full transverse width of the
`vertebral space?
` MR. MILLER: Objection, form.
` THE WITNESS: Yes.
`BY MR. DAUCHOT:
` Q. In what cases does that happen?
` MR. MILLER: Same objection.
` THE WITNESS: If we are talking in general,
`in some of my cases that I performed.
`BY MR. DAUCHOT:
` Q. Okay. When do you not go the full length?
` A. Well, when I get an x-ray and it looks as
`though it's not spanned the full length.
` Q. I'm sorry. My question is, generally
`speaking, is NuVasive's XLIF procedure designed to
`insert an implant along the full transverse width of
`the intervertebral space?
` MR. MILLER: Objection, form.
` THE WITNESS: That would be a true
`statement.
`BY MR. DAUCHOT:
` Q. Now you'll agree with me that in order to
`place an implant along the full transverse width of the
`intervertebral space one does not need to actually
`remove the contra-lateral annulus, correct?
`
`TSG Reporting - Worldwide (877)702-9580
`
`Page 20
`
`
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