`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALPHATEC HOLDINGS, INC., and
`ALPHATEC SPINE, INC.,
`Petitioners,
`vs,
`NUVASIVE, INC.,
`Patent Owner.
`
`Case No. IPR2019-00362
`US Patent No. 8,361,156
`
`DEPOSITION OF
`CARL R. McMILLIN, Ph.D.
`Durango, Colorado
`January 8, 2020
`9:14 a.m.
`
`Reported by: Heidi K. Konsten, RPR, CCR
`Nevada CCR No. 845 - NCRA RPR No. 816435
`JOB NO. 596166
`
`1
`2
`
`3 4 5
`
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC
`IPR2019-00362, Ex. 1051, p. 1 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`★★★★*★
`
`Page 2
`
`ALPHATEC HOLDINGS, INC., and
`ALPHATEC SPINE, INC.,
`Petitioners,
`vs,
`NUVASIVE, INC.,
`Patent Owner.
`
`Case No. IPR2019-00361
`US Patent No. 8,187,334
`
`1
`2
`3
`
`4 5 6 7 8
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC
`IPR2019-00362, Ex. 1051, p. 2 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`★★★★*★
`
`Page 3
`
`ALPHATEC HOLDINGS, INC., and
`ALPHATEC SPINE, INC.,
`Petitioners,
`vs,
`NUVASIVE, INC.,
`Patent Owner.
`
`Case No. IPR2019-00546
`US Patent No. 8,187,334
`
`1
`2
`3
`
`4 5 6 7 8
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC
`IPR2019-00362, Ex. 1051, p. 3 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Deposition of CARL R. McMILLIN, Ph.D.,
`Volume 1, taken at 501 Camino del Rio, Durango,
`Colorado, on Wednesday, January 8, 2020, at 9:14
`a. m.
`, before Heidi K. Konsten, Certified Court
`Reporter in and for the State of Nevada.
`
`Page 4
`
`APPEARANCES OF COUNSEL
`For the Petitioners:
`DAVID P. DALKE, ESQ.
`WINSTON Sc STRAWN
`333 South Grand Avenue
`Los Angeles, California 90071
`(213) 598-9084
`(213) 565-1750
`For the Patent Owner:
`JAD M. MILLS, ESQ.
`SONJA R. GERRARD, ESQ.
`Wilson Sonsini Goodrich & Rosati
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, California 94105
`(415) 947-2027
`(415) 947-2000 Fax
`
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`
`6 7
`
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 4 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`INDEX
`
`Page 5
`
`CARL R. McMILLIN, Ph.D.
`Examination by Mr. Dalke
`Examination by Mr. Mills
`
`Page
`
`6
`55
`
`EXHIBITS
`
`No.
`
`Description
`(None marked.)
`
`Page
`
`★ ★ ★ ★ ★
`
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1 2 3 4 5 6 7 8
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 5 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`DURANGO, COLORADO
`Wednesday, January 8, 2020
`9:14 a.m.
`DEPOSITION OF CARL R. McMILLIN, Ph.D.
`******
`
`Page 6
`
`CARL R. McMILLIN, PH.D.,
`having been first duly sworn, was examined and
`testified as follows:
`
`EXAMINATION
`
`BY MR. DALKE:
`Q
`Good morning.
`A
`Good morning.
`Q
`My name is David Dalke. I'm an attorney
`representing Alphatec in some of these proceedings
`that have been filed. And we're here obviously to
`take your deposition. I'm going to ask you some
`questions.
`
`One of the -- I see that you brought
`something with you; is that accurate?
`A
`Yes.
`Q
`What did you bring?
`A
`I have three clean copies of the
`declaration,
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`
`6 7
`
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 6 of 61
`
`
`
`Page 7
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Okay. And by "declaration," you mean
`Q
`the declarations that were filed in these IPR
`proceedings?
`That's correct.
`A
`Can I hand -- oh, jeez.
`Q
`A
`Certainly.
`Q
`This isn't going to work very well, is
`it? Thank you. Okay. I'll pass those back to
`you, if you need them.
`Have you ever been deposed before.
`
`Doctor?
`A
`Q
`rules.
`
`Yes.
`Okay. So I'm sure you know the ground
`
`When was the last time you were deposed?
`I think somewhere in -- five to ten
`
`A
`years ago.
`Do you remember -- was that the only
`Q
`time you've been deposed?
`A
`No.
`Q
`How many times?
`A
`Somewhere between six and ten or a
`dozen.
`Q
`And the most recent was five to ten
`years ago; is that correct?.
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 7 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 8
`
`To my recollection.
`A
`Q Do you recall generally what the subject
`matter was of those depositions?
`A
`They varied.
`Q
`Could you give me an example?
`A
`The first time was when I was a director
`of R&D at AcroMed, and it was a case on marketing
`of spine plates. I was deposed several times in
`the Bard vs. Gore patent dispute over the original
`patents on expanded PTFE, vascular grafts.
`I've been deposed by a spine company
`that was accused of making their instruments too
`sharp by a patient that -- a surgeon had cut the
`vena cava with one of the surgical instruments.
`And my opinion on that was if there was anything
`that the company should do, it would be to make
`the instruments sharper.
`I believe I was deposed on a contractual
`manufacturing dispute on spine -- some spine
`product.
`In any of the cases that you have
`Q
`previously been deposed, was the subject matter
`spinal fusion implants that we're here to talk
`about today?
`A
`.Yes. , The most recent one was Bianco vs.
`Litigation Services j 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 8 of 61
`
`
`
`Page 9
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Globus on a theft of trade secrets case on an
`expandable spine fusion cage.
`Q And who did you represent or who were
`you working for in that case?
`A I was working with Dr. Bianco.
`Q And do you recall when that deposition
`
`was?
`
`It was likely about five years ago.
`A
`Do you remember generally what your
`Q
`opinions were in that case? I don't need -- you
`know, nothing confidential. Just in general.
`A In general, the gist of the case was
`that Dr. Bianco had provided drawings to Globus,
`and they declined to make -- they told him they
`declined to make his implant. And then later on
`they introduced a very similar implant by
`themselves, and I was asked to be an expert on the
`design of spine implants.
`And essentially my opinion was that
`oftentimes companies are given drawings of
`implants and instruments that are not totally
`ready for production, and it's common for the
`companies to then modify them to make them work.
`Q Did you provide testimony at trial in
`that case?Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1 234 5 67 8
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 9 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`A
`Q
`
`Yes.
`Do you remember where that trial was
`
`Page 10
`
`held?
`
`In Texas, very close to Louisiana.
`A
`Okay. Thank you. All right. I kind of
`Q
`went sideways a little bit here.
`Would you state your name and spell your
`name for the record, please.
`A
`Carl, C-A-R-L, McMillin,
`M-C-M-I -L-L-I-N.
`And state your home address, please.
`Q
`A
`6099 Warblers Roost, W-A-R-B-L-E-R-S,
`R-O-O-S -T, in Brecksville, B-R-E-C-K-S-V-I-L-L-E,
`Ohio.
`
`And you understand you took an oath
`
`Q
`today?
`A
`Yes, I do.
`It's the same kind of oath and has the
`Q
`same force and effect as if you take the same oath
`in a court of law.
`Do you understand?
`A
`Yes, I understand that.
`So during our time together, if you
`Q
`don't understand any of my questions, would you
`please let me know?
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 10 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 11
`
`I will.
`A
`Q
`And if I -- if you answer a question
`that I ask, can we agree that you will
`understood -- that you will have understood the
`question?
`A
`To the best of my ability, I will
`have -- I will assume that I understand your
`question. I can envision circumstances where
`after the fact I might be confused, but I can't --
`Q
`Sure, and that's fine. I guess that
`goes to my next point.
`If at any point you want to -- decide to
`change any of your answers, let me know, and I'm
`happy to have that discussion with you. Okay?
`A
`Okay.
`Q
`Is there any reason today that you can't
`give full and complete testimony?
`A
`No.
`Q
`And obviously, as you have seen, we have
`a court reporter here. So to make her job easier
`and make the record more clean, if you would.
`please, give verbal answers as opposed to head
`shakes and the like. That would be helpful for
`the record.
`Will you do that? .
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 11 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 12
`
`A I will do that.
`Q I also suspect that in -- from time to
`time, your attorney may interject some objections
`to my questions. And unless he instructs you not
`to answer, will you please nonetheless answer my
`question, even if he has an objection?
`A
`Would you say that again?
`Q
`Yes.
`There may be times during our time
`together where your attorney may lodge an
`objection to my question. Unless he instructs you
`not to answer, I'm still entitled to the answer to
`the question.
`Do you understand?
`Okay.
`A
`We can take breaks whenever
`All right.
`Q
`you like and when it makes sense to take a break.
`The only question -- the only caveat to that,
`though, is I would appreciate that you don't ask
`for a break if there is a question pending.
`A
`Okay.
`So what were the documents
`Q
`All right.
`that you brought with you today. Doctor? Those
`are the declarations that you filed in this case;
`is that correct?
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1 2345 6 7 8
`
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 12 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 13
`
`A
`That1s correct.
`And for the record, you filed
`Q
`declarations that are Exhibit No. 2057 in three
`different IPRs. The case numbers are IPR
`2019-00361, IPR 2019-00362, and IPR 2019-00546; is
`that correct?
`A
`That's correct.
`Are there any sub -- aside from the
`Q
`cover page, are there any substantive differences
`in the declarations that you filed?
`A
`To my knowledge, they are all totally
`identical except for the cover page.
`So I'm going to hand you. Doctor, what
`Q
`is Exhibit 2057 in IPR 2019-00361.
`MR. DALKE: Sorry, Jad.
`MR. MILLS: Thank you.
`BY MR. DALKE:
`Do you recognize that document. Doctor?
`Q
`A
`It appears to be identical to the copy
`that I was just given ten minutes ago.
`Great.
`Q
`If you turn to page 25 of that exhibit,
`please. Doctor, it's the last page.
`Is that your signature on that page?
`That is my signature.
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`A
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 13 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 14
`
`To the best of my knowledge, they were
`
`When you signed that declaration --
`Q
`these declarations on October 29, 2019, were they
`accurate?
`A
`accurate.
`Are they accurate today?
`Q
`A
`To the best of my knowledge, they1 re
`still accurate.
`Is there anything that you want to
`Q
`change in any of your declarations?
`A
`No, there's nothing that I want to
`change.
`Do you understand that there were
`Q
`petitions that were filed in each of these
`proceedings?
`A
`Yes, I understand that.
`Did you review each of the petitions in
`Q
`each of the cases?
`A
`I read through each of the -- the
`petitions
`Q
`A
`Q
`petitions
`A
`
`And when did you do that?
`Early on in the case.
`How many times have you read those
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Once or twice.
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 14 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 15
`Do you understand that Alphatec retained
`Q
`an expert by the name of Dr. Charles Branch in
`these proceedings?
`A
`Yes, I do.
`Do you know Dr. Branch?
`Q
`A
`No, I don11.
`Do you -- do you understand that
`Q
`Dr. Branch filed three declarations, one in each
`of the IPRs that we're discussing today?
`A
`I was unaware of the numbers that he had
`filed.
`I was aware that he had filed at least one
`declaration.
`One declaration in each one of the
`Q
`proceedings. Is that -- is that your
`understanding?
`A
`I have no idea.
`Okay. Do you understand that these
`Q
`three proceedings cover --or are directed to. I
`guess, two different United States patents?
`A
`Yes, I'm aware of that.
`And one of those patents is United
`Q
`States Patent No. 8187334. Maybe paragraph ten
`might help you on your --
`A
`The number again was?
`,8187334.
`Q
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 15 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 16
`
`A
`Yes.
`And the other patent that's at issue in
`Q
`these proceedings is United States Patent
`No. 8361156.
`A
`Yes, I agree.
`And so if we just use -- if I use the --
`Q
`the shorthand and refer to the '334 patent, will
`you understand what I'm talking about today?
`A
`Yes, I will.
`And similarly, if I use the shorthand
`Q
`'156, will you understand that's the patent I'm
`referring to today?
`A
`Yes, I will.
`Were you aware of either the '334 or the
`Q
`'156 patents before your work in the case?
`A
`No, I was not.
`Are you aware that the -- the '334 and
`Q
`the '156 patents were previously subject to IPR
`proceedings? So not this case, but earlier?
`A
`I seem to recall seeing something like
`that in the IPRs.
`Do you recall what -- for example, what
`Q
`the outcome of the IPR proceeding that Medtronic
`brought -- I'm sorry, that involved Medtronic and
`NuVasive about ,the '334 patent? Do you have an
`Litigation Services J 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 16 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 17
`
`understanding of what the outcome of that was?
`A
`To my recollection, they disallowed
`several of the claims.
`Are you trained as a medical doctor?
`Q
`A
`No, I'm not.
`Have you ever performed any spine
`Q
`surgeries on a living patient?
`A
`I have scrubbed in and viewed spine
`surgeries , but I've not actually performed them
`myself.
`About how many times have you scrubbed
`Q
`in and viewed spine surgeries?
`A
`Somewhere between six and a dozen.
`And over what period of time? What --
`Q
`so when. I guess, would those -- let's start with
`when.
`
`When would those 6 to 12 times have
`
`occurred?
`Those would have been while I was an
`A
`employee of AcroMed Corporation.
`Over what period of time?
`Q
`A
`You have a copy of my CV. I would
`review the exact dates on that, but it's --
`Let's see. Maybe paragraph three of the
`Q
`declaration,that you have in front of you will
`Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 17 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 18
`
`help refresh your recollection.
`A
`Yes. So I was at AcroMed between 1989
`and 1997.
`So the --
`Q
`And so it was within that period that I
`A
`viewed and scrubbed in on spine surgeries.
`Okay. Have you ever performed any spine
`Q
`surgeries on a cadaver?
`A
`I do not believe so, no.
`So going back to the 6 to 12 times that
`Q
`you scrubbed in and viewed surgeries while you
`were working with AcroMed, what were the
`circumstances for -- why were you attending those
`surgeries 9
`Most of the times I had developed a new
`A
`implant or a new instrument, and the surgeon
`requested my presence to see how the instrument or
`the implant functioned and to review how it was
`used and if any problems occurred.
`Okay. So of those 6 to 12 times. can
`Q
`you recall how many dealt specifically with
`implants versus instruments?
`A
`It was probably about two-thirds
`implants and one-third instruments.
`And by "instruments," do you mean
`Q
`Litigation Services J 800-33U-1112
`www.litigationservices.com
`
`--
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 18 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 19
`
`well, you tell me. What do you mean by
`"instruments"?
`A Instruments could include retractors or
`broaches or curettes or any of the types of
`instruments that are routinely used to do spine
`surgery.
`Q Do you recall whether any of the
`implants that you were -- that were involved in
`the surgeries that you attended, were any of those
`the so-called Brantigan implants?
`A I don't recall. There may have been.
`Q Okay. And when I refer to the
`"Brantigan implants," do you have an understanding
`of what I'm asking you?
`A As a matter of fact, I do not. Because
`I was involved in several different -- both his
`PLIFs, the ALIFs, and the stackable vertebral body
`replacements.
`Q I'm going to hand you what's been marked
`as Exhibit 1007 in IPR 2019-00621. It's a
`document entitled -- it's U.S. Patent No.
`and the author is Brent Brantigan.
`Do you recognize that document,
`A Yes, I do.
`Have you seep it before today?
`Q
`day?
`Litigation Services
`800-330-1112
`www. litigationservices.com
`
`5192327,
`
`Doctor?
`
`1 2 3 4 5 67 8
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 19 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 20
`
`Yes, I have.
`A
`Were the implants that you were
`Q
`observing the surgeries for, were those the same
`kinds of implants that are described in the
`Brantigan '327 patent?
`A
`I don't recall whether I specifically
`scrubbed into these, but I helped design them,
`so . . .
`And when you -- what do you mean by you
`Q
`helped design them?
`A
`I developed materials, optimized
`dimensions, oversaw the development of instruments
`for the implantation of the devices -- although I
`don't recall any instruments that I specifically
`developed for this -- for the Brantigan one -- and
`other aspects of it.
`Q
`Okay. I believe you said that you
`optimized dimensions.
`What do you mean by "optimized
`dimensions"?
`A
`If you look at Figure 8 and Figure 9,
`you will see that the vertebral body replacement
`is stacked one on top of another to make a long
`implant. It was desired at the time that we be
`able to make any length of implant from a Segal
`Litigation Services | *800-330-1112
`3
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 20 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 21
`implant up to perhaps 150 or 175 millimeters tall.
`And I -- you make that by having
`different heights that stack together. And they
`wanted every -- within every 2 millimeters a --
`some combination of these cages that would fit
`together to give the precise dimensions so that
`you -- it would be feasible to put it into any
`patient that they would encounter.
`So I was the one that had to look at the
`various thicknesses of the cages to enable them to
`stack up. I also had to make sure that the teeth
`were aligned properly so that they would
`interdigitate as the spine goes in. I generated
`the CAD drawings that went out for manufacture.
`We made the splines out of both titanium
`and out of carbon fiber composite. When the cages
`came in, I inspected them for dimensional
`correctness, evaluated which material of the
`spline would work best in the device. As it
`turned out, the titanium slid out too easily. So
`it would be feasible, as the surgeon was trying to
`implant the construct, it would fall apart in his
`hands.
`
`So it's that type of -- of things that
`you need to.do .to qo from a .concept to a final
`Litigation Services | 800-S30-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 21 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`device and other aspects of it.
`Q Did you -- when you were working on
`optimizing the design, did you do any work with
`respect to the length and the width of the
`implants?
`
`Page 22
`
`MR. MILLS: Objection. Form.
`THE WITNESS: I can't recall at this
`time whether or not -- I had been developing
`dimensions for artificial spinal disks, functional
`spinal disks at the time. And
`I do not recall
`whether we used any of that information in the
`finalization of the dimensions of these. So I --
`I may or may not have been involved with that. I
`was certainly aware of it.
`BY MR. DALKE:
`Q
`Well, how do you mean -- go ahead.
`A
`Because I was doing CAD-CAM drawings to
`send out for prototypes.
`Q
`So how did that make you aware of the
`length and width dimensions?
`A
`Well, because if you're sending
`something out to have somebody make it, you need
`to tell them what sizes to make it and you have to
`develop the tolerances. And the tolerances in
`this turneid.out, to be very critical, that the --
`Litigation Services j 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 22 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 23
`
`for example, the spline and the grooves in the
`stacked one had to be a little bit tighter
`tolerance than common for that type of dimension
`so that it would -- you could assemble it and it
`would not fall apart.
`When you say "spline," what are you
`Q
`referring to? Is there -- is that component -- is
`the spline component reflected anywhere in the
`drawings of the Brantigan '327 patent?
`A
`Yes. That's the central component in
`Figure 8 , is the bar or spline, and we called it a
`spline.
`I'm not sure what he calls it in --
`So if you look at Figure 8, for example.
`Q
`of the 1 327 patent, there's a -- a No. 15.
`Do you see the No. 15 in the -- towards
`the bottom of the image?
`A
`Yes.
`Is that the spline that you're referring
`Q
`
`to?
`
`A
`Q
`
`Yes.
`Okay. Thank you.
`Do you know -- I'm talking about -- I
`want to ask you a couple of questions about
`surgical approaches.
`Do you know whether the Brantigan
`Litigation Services | 800-330-1112^
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 23 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 24
`implants, as described in the '327 patents, can be
`inserted using an anterior approach?
`A Yes. Both the single level spine fusion
`cage and the corpectomy cage are routinely
`implanted using the anterior approach.
`Q Now, you said corpectomy implant. Can
`you -- again, referring to the Brantigan '321, can
`you point to or help me identify with an image
`there that reflects what you mean by corpectomy?
`A Figure 8.
`Q And what do you mean by "corpectomy
`cage," Doctor?
`A In a corpectomy surgery, you are
`generally removing an entire vertebral body or two
`and then stabilizing the spine by a construct that
`attaches the remaining vertebral bodies. As
`opposed to a fusion cage, where you are removing a
`disk and getting the -- just two adjacent
`vertebral bodies to fuse together.
`Q Okay. Thank you for that clarification.
`Going back to the surgical approaches,
`are you aware whether the Brantigan '327 -- the
`implants that are described in the Brantigan '327
`patents, can those be inserted in a posterior
`approach?Litigation Services | 800-330-1112
`www.litigationservices.com
`
`1 2 3 4 5 6 7 8
`
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 24 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 25
`
`In Figure 2, Brantigan shows a
`A
`hemi-device that was never developed commercially.
`But that would likely be put in by a posterior
`approach , one on one side of the spinal cord and
`the other on the other side of the spinal cord.
`And similarly, I guess the last
`Q
`question , are you aware of -- the Brantigan
`implants as described in the '327 patents, can
`they be inserted via a lateral approach?
`A
`I have never seen anybody implant them
`in a lateral approach, and it's not designed to do
`that.
`
`I'm not sure if I asked you this or not.
`Q
`I apologize if I did.
`Prior to your work on this case, had you
`seen the Brantigan '327 patent?
`A
`Yes, I had.
`In what circumstances?
`Q
`A
`I kept an Evergreen list of all of the
`commercial and experimental spine fusion cage
`patents and disclosures and articles. And I'm
`sure I included this as a -- one in there, along
`with, you know -- just because we were routinely
`using it, yes.
`What do vou mean by "we were routinely
`Q
`Litigation "Services | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 25 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 26
`
`using it"?
`A Well, we were designing and selling
`these devices.
`Q You mean when you were
`A
`When I worked at AcroMed.
`Q
`Okay. I'm going to hand you another
`document, Doctor. It is Exhibit No. 1040 that was
`filed in IPR 2019-00352. And it's United States
`Patent Publication No. U.S. 2002/0165550, and the
`first named inventor is Frey. I'm not going to
`throw this one at you.
`And I'm going to point him to that, if
`you want to just -- thanks.
`Do you recognize that document, Doctor?
`Take your time. We're ultimately going to get to
`that Figure 59 there, so if you keep your finger
`there while you're thumbing through, that will
`save a little time.
`A
`Okay.
`Q
`Do you recognize that document, Doctor?
`A
`Yes, I do.
`Q Okay. Have you seen it prior to your
`work on this case?
`A Not to my recollection.
`Q
`And if I could direct your attention.
`Litigation Services ] 80CT-330-1112
`www.litigationservices.com
`
`1 2 34 5 67 8
`
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 26 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 27
`
`please, to Figure 59 in that patent.
`Do you recognize that figure, Doctor?
`A
`Yes, I do.
`And what is -- what is shown in that
`Q
`figure, Doctor?
`A
`What's shown is generally what's
`described these days, at least, as a boomerang
`implant.
`And if we refer -- during the purposes
`Q
`of our discussions today, if we refer to that as a
`Frey implant, will you understand what I'm talking
`about?
`A
`Yes.
`In the work that you did where you were
`Q
`observing surgeries 6 to 12 times during your time
`at AcroMed, were you ever involved in -- were you
`ever witness to a surgery that implanted a Frey
`implant?
`A
`Q
`Thank you ■
`
`No, I was not.
`Now, you can put that down, Doctor.
`
`What did you do to form the opinions
`that you expressed in your declarations. Doctor?
`A
`That's a rather broad question.
`Right,. So maybe we can go down -- we'll
`Q
`Litigation Services f 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 27 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 28
`
`how did you --
`I could say I reviewed documents and --
`Sure.
`Yeah.
`When -- who -- let's start with when --
`
`just --
`A
`Q
`A
`Q
`or who.
`
`Who contacted you about serving --
`potentially serving as an expert in this case?
`A
`I was originally contacted through ORC
`Consulting and asked whether I felt I had the
`expertise to be an expert on this case. And I
`did. And that my information was then sent to the
`law firm, I assume, who must have decided that I
`was an appropriate expert and contracted through
`ORC to hire me as a consultant on the case.
`I'm not sure, are you saying -- is it
`Q
`the letters O-R-C or is it -- is it --
`A
`It's the letters O-R-C. It had
`several -- it's a big consulting firm that finds
`experts
`Q
`A
`
`All right.
`And I've done several cases through
`
`them.
`
`Q
`A
`
`Okay. When --
`So my. file -- my CV was on file, and ...
`Litigation Services J 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 28 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Page 29
`
`Q And when did they contact you?
`A I would have to check my e-mails to give
`you a date on that.
`Q Can you give me an estimate of how --
`how soon -- how much time prior to the date you
`filed your declaration, which was October 29 of
`2019? A month? Two months?
`A Probably two months. Let me look again.
`Perhaps two months.
`Q And what was the next step after you
`worked with ORC?
`MR. MILLS: I'm just going to issue a
`caution or instruction that in this line of
`questioning -- I don't think he's asking you for
`the content of communications with counsel. But
`I'm cautioning you not to go into any -- the
`content of any communications with counsel.
`BY MR. DALKE:
`Q Yeah, I just want to know what happened
`next. I'm not interested at all in conversations
`that you had with counsel who are here sitting in
`the room or any other counsel you had retained.
`I'm just trying to get a feel for what happened
`after you spoke with -- or interacted with ORC.
`What was the next.step?
`Litigation Services | 8o0-330-1112
`www.litigationservices.com
`
`1 2 34 5 67 8
`
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 29 of 61
`
`
`
`CARL MCMILLIN, PH.D. - 01/08/2020
`
`Page 30
`
`A
`I talked with the law firm lawyers.
`They then sent me documents, which I reviewed, and
`we then discussed those documents.
`Do you remember who you spoke with.
`Q
`which lawyers? Not what you said, just who you
`spoke with.
`A
`Well, the lead one was Sonja.
`Anyone else?
`Q
`A
`If I can guess at a name, I think there
`was a Mike Rosato or ...
`Okay. Anyone else?
`Q
`A
`None that I can recall.
`Do you recall what kind of documents you
`Q
`reviewed?
`
`MR. MILLS: I'm going to caution the
`witness , based on my prior instruction, you can
`identify documents that you considered or relied
`on for forming your opinions.
`THE WITNESS: The --a copy of the IPRs,
`a copy of the relevant patents.
`BY MR. DALKE:
`Anything else?
`Q
`A
`I'm trying to recall if there were
`other - - there was at least one document authored
`by Dr. Brantiqan on sizing..
`Litigation Services^ | 800-330-1112
`www.litigationservices.com
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1051, p. 30 of 61
`
`
`
`CARL MCMILLIN, PH.D.
`
`01/08/2020
`
`Q
`A
`
`Anything else?
`Nothing else that I can recall at this
`
`Page 31
`
`time.
`
`So if you turn to paragraph nine of your
`Q
`declaration. Doctor, in the second sentence of
`that paragraph, it says your -- "My opinions are
`based on my skills, knowledge, training,
`education, and experience in spinal fusion implant
`design and my examination of the materials cited
`in this declaration."
`Did I read that correctly?
`Yes.
`A
`Did you rely on anything in forming your
`Q
`opinions that was not cited in this declaration?
`A Nothing I can think of that had a
`substantial input on my opinions.
`Q
`So I'm not sure what you mean by had a
`substantial input on your opinions.
`A
`Well, one of the other things that I saw
`was the commercial Medtronic brochure on the
`boomerang implant. So that did not specifically
`change my opinions, but it confirmed opinions that
`I already had.
`Q
`And that may or may not be cited i