throbber
Barton Sachs, MD - 2/25/2014
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` NUVASIVE, INC., )NO.: IPR2013-00206
`
` Petitioner, ) IPR2013-00208
`
` vs. )
`
` WARSAW ORTHOPEDIC, INC., )
`
` Patent Owner. )
`
` VIDEOTAPED DEPOSITION OF
`
` BARTON SACHS, M.D.
`
` 9:09 a.m.
`
` February 25, 2014
`
` 6650 Rivers Avenue
`
` Charleston, South Carolina
`
` Annette Pacheco, RPR, RMR, CCR-B-2153
`
`PAGES 1 - 185
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`NUVASIVE 1028
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
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`Barton Sachs, MD - 2/25/2014
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`A P P E A R A N C E S O F C O U N S E L
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`O n b e h a l f o f t h e P e t i t i o n e r :
`
` S T E P H E N R . S C H A E F E R , E s q .
`
` M I C H A E L T . H A W K I N S , E s q .
`
` M I C H A E L A M O N , E s q .
`
` F I S H & R I C H A R D S O N
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` 3 2 0 0 R B C P l a z a
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` 6 0 S o u t h S i x t h S t r e e t
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` M i n n e a p o l i s , M i n n e s o t a 5 5 4 0 2
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` 6 1 2 - 3 3 5 - 5 0 7 0
`
` s c h a e f e r @ f r . c o m
`
` h a w k i n s @ f r . c o m
`
` a m o n @ f r . c o m
`
`O n b e h a l f o f t h e P a t e n t O w n e r :
`
` L U K E D A U C H O T , E s q .
`
` S T E V E N A . P A P A Z I A N , E s q .
`
` N I M A L K A R . W I C K R A M A S E K E R A , E s q .
`
` K I R K L A N D & E L L I S L L P
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` 3 3 3 S o u t h H o p e S t r e e t
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` L o s A n g e l e s , C a l i f o r n i a 9 0 0 7 1
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` 2 1 3 - 6 8 0 - 8 2 4 6
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` l u k e . d a u c h o t @ k i r k l a n d . c o m
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` s t e v e n . p a p a z i a n @ k i r k l a n d . c o m
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` n i m a l k a . w i c k r a m a s e k e r a @ k i r k l a n d . c o m
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`A l s o P r e s e n t : J o n a t h a n S p a n g l e r
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` J o h n E n g l i s h
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`Barton Sachs, MD - 2/25/2014
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` INDEX TO EXAMINATIONS
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` Examination Page
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`Examination by Mr. Schaefer 5
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`Examination by Mr. Dauchot 172
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`Examination by Mr. Schaefer 181
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` - - -
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` INDEX TO EXHIBITS
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`Deposition
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` Exhibit Description Page
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`Exhibit 2038 Declaration of Barton L. Sachs,
`
` M.D. in IPR2013-00206 19
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`Exhibit 2038 Declaration of Barton L. Sachs,
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` M.D. in IPR2013-00208 19
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`Exhibit 1027 Page 29 of Exhibit 1003 184
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` (Original Exhibits 2038, 2038 and 1027 have been
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`attached to the original transcript.)
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`Barton Sachs, MD - 2/25/2014
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` (Reporter disclosure made pursuant to
`
` Article 8.B. of the Rules and Regulations of the
`
` Board of Court Reporting of the Judicial Council
`
` of Georgia.) 08:52:10
`
` THE VIDEOGRAPHER: This is the beginning 09:07:10
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` of tape No. 1 in the deposition of Dr. Barton 09:07:32
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` Sachs in the matter of NuVasive, Inc. versus 09:07:36
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` Warsaw Orthopedic, Inc., Case No. IPR2013-00208 09:07:40
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` and Case No. IPR2013-00206. The date today is 09:07:48
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` February 25th, 2014. The time on the monitor is 09:07:57
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` 9:09. 09:08:00
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` My name is Doug White and I'm the 09:08:01
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` videographer. The court reporter is 09:08:03
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` Annette Pacheco. We are with Huseby, 09:08:05
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` Incorporated. Counsel please introduce 09:08:08
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` yourselves after which the court reporter will 09:08:10
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` swear in the witness. 09:08:12
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` MR. SCHAEFER: I'm Steve Schaefer from 09:08:14
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` Fish & Richardson representing the Petitioner 09:08:16
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` NuVasive. 09:08:20
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` MR. HAWKINS: I'm Michael Hawkins from 09:08:23
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` Fish & Richardson representing the Petitioner 09:08:25
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` NuVasive. 09:08:27
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` MR. AMON: Michael Amon on behalf of the 09:08:29
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` Petitioner NuVasive. 09:08:30
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`Barton Sachs, MD - 2/25/2014
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` MR. SPANGLER: Jonathan Spangler from 09:08:32
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` NuVasive. 09:08:33
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` MR. ENGLISH: John English from NuVasive. 09:08:35
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` MR. DAUCHOT: Luke Dauchot on behalf of 09:08:37
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` the patent owner. 09:08:40
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` MR. PAPAZIAN: Steve Papazian on behalf of 09:08:40
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` the patent owner. 09:08:41
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` MS. WICKRAMASEKERA: Nimalka 09:08:41
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` Wickramasekera on behalf of the patent owner and 09:08:43
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` the witness. 09:08:45
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` BARTON SACHS, M.D., 09:08:50
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`having been first duly sworn, was examined and 09:08:50
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`testified as follows: 09:08:50
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` EXAMINATION 09:08:50
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`BY MR. SCHAEFER: 09:08:50
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` Q. Dr. Sachs, I'm Steve Schaefer. As I 09:09:02
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`mentioned, I represent NuVasive in this matter. So 09:09:05
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`we're here to talk about -- 09:09:08
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` A. Nice to meet you. 09:09:09
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` Q. Thank you. So we're here to talk about 09:09:10
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`the '997 patent or U.S. Patent No. 8251997. That's 09:09:14
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`your understanding? 09:09:19
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` A. Yes, sir. 09:09:19
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` Q. You've had your deposition taken before on 09:09:20
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`a number of occasions? 09:09:25
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`Barton Sachs, MD - 2/25/2014
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` A. Yes, I have. 09:09:26
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` Q. And that's been as a fact witness and as 09:09:27
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`an expert witness? 09:09:30
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` A. Yes, that's correct. 09:09:31
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` Q. Okay. How long ago was it that you were 09:09:32
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`last deposed? 09:09:36
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` A. Two -- was it 2000 -- it was actually 09:09:36
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`in -- the deposition in this case. So it was in 2010 09:09:47
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`or 2011. 09:09:50
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` Q. Okay. Okay. 09:09:51
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` A. In February. 09:09:54
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` Q. You've conferred with your counsel about 09:09:54
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`the ground rules for this deposition? 09:09:56
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` A. Yes, sir. 09:09:58
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` Q. Okay. So let me go over a few of those 09:09:59
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`before we begin. First off, my voice is strained a 09:10:03
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`little today, but I'll try to make it through it. 09:10:08
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`But let me finish my questions before you answer so 09:10:11
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`that we don't talk over one another. 09:10:14
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` The second is please answer audibly. 09:10:18
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`Noddings of the head will not be recorded by the 09:10:21
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`court reporter. 09:10:24
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` A. I understand. 09:10:24
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` Q. Okay. Great. The other thing is your 09:10:25
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`counsel may object to some of my questions. I may 09:10:30
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`rephrase those questions or I may not rephrase those 09:10:33
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`questions. But you understand you're to answer my 09:10:37
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`question to the best of your ability unless your 09:10:40
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`lawyer tells you not to answer. You understand that? 09:10:43
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` A. Yes, sir. 09:10:46
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` Q. Okay. Now, this being a special type of 09:10:47
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`deposition, you're under cross-examination. That 09:10:52
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`actually means that during any breaks, you won't be 09:10:56
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`talking to your counsel about anything of substance. 09:10:59
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`You understand that; right? 09:11:03
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` A. Yes. 09:11:04
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` Q. Okay. Let's -- let's start out talking a 09:11:04
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`little bit about your current practice. 09:11:09
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` MR. DAUCHOT: Just to clarify, Counsel, of 09:11:12
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` substance relating to the deposition. 09:11:14
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` MR. SCHAEFER: That's correct. That's 09:11:17
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` correct. Or anything about the '997 patent. 09:11:19
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` MR. DAUCHOT: No. I didn't mean -- you 09:11:27
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` just said anything of substance. 09:11:28
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` Q. (By Mr. Schaefer) Okay. I want to talk a 09:11:33
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`little bit about your current practice. Are you 09:11:35
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`currently practicing medicine? 09:11:38
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` A. Yes, I am. 09:11:39
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` Q. And what kind of practice is that? 09:11:40
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` A. I'm an orthopedic spine surgeon. I have 09:11:42
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`an active orthopedic spine practice. I'm a Professor 09:11:46
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`of Orthopedics at the Medical University of South 09:11:51
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`Carolina where I practice. I see patients as 09:11:53
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`outpatients in clinic settings, evaluate, manage and 09:11:56
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`treat. And I also continue to do surgery and operate 09:12:01
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`on patients for spinal disorders. 09:12:04
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` Q. What types of procedures do you do? 09:12:06
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` A. I do a myriad of various types of spine 09:12:11
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`procedures. Basically anything that involves the 09:12:15
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`cervical spine, the thoracic spine, the lumbar spine 09:12:19
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`in young patients, old patients, middle-aged patients 09:12:23
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`from the anatomic upper portion -- uppermost portion 09:12:27
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`of the spine to the sacrum and lowermost portion of 09:12:31
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`the spine, and various different approaches for 09:12:36
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`whatever particular problem you might be thinking of. 09:12:39
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` Q. What types of approaches do you use? 09:12:42
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` A. Would you like me to list -- list 09:12:45
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`everything? Or I can give you examples of approaches 09:12:49
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`from an anterior approach to the spine, posterior 09:12:54
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`approaches to the spine, minimally invasive surgical 09:12:58
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`approaches to the spine, lateral approaches to the 09:13:02
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`spine, off-angle approaches to the spine. 09:13:05
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` I guess that's -- probably whichever 09:13:11
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`technique and whichever area needs -- I need to get 09:13:16
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`into, whether it's a retroperitoneal approach or a 09:13:20
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`Barton Sachs, MD - 2/25/2014
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`transperitoneal approach or posterior -- or a 09:13:24
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`thoracic approach, basically I have to figure out 09:13:29
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`what the appropriate anatomy -- what the problem is, 09:13:35
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`what the appropriate anatomy is for the patient and 09:13:38
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`how to enter that particular area of the spine in the 09:13:41
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`least destructive manner, be able to perform the 09:13:46
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`operation around the spine that needs to be done, and 09:13:49
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`then exit and put things back together again. 09:13:53
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` Q. Do you perform fusion procedures? 09:13:56
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` A. Yes, I do. 09:14:00
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` Q. And what types of fusion procedures do you 09:14:00
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`perform? 09:14:06
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` A. You're sort of asking me a broad question. 09:14:07
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`I perform spinal arthrodesis and spinal fusion 09:14:11
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`procedures. A fusion procedure is the end result, 09:14:18
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`the outcome of performing an arthrodesis procedure, 09:14:20
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`which is preparing the spine in some way so that it 09:14:23
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`physiologically progresses on and stabilizes and 09:14:26
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`fuses. And I do that in many different manners. I'm 09:14:31
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`not sure what -- what you want me to say about that. 09:14:35
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` Q. Do you do fusion procedures using a direct 09:14:38
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`lateral approach? 09:14:41
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` A. Yes, I do. 09:14:41
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` Q. And what type of -- what levels or types 09:14:43
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`of patients do you do such an approach in? 09:14:49
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` MR. DAUCHOT: Object to the form. 09:14:52
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` THE WITNESS: Now, I take it when you talk 09:14:54
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` about direct lateral approach, you're -- I mean, 09:14:56
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` for me, a lateral approach is basically from -- 09:15:02
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` an approach from the side of the body. It's 09:15:06
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` also from the side of the patient's spine, 09:15:09
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` relatively speaking. 09:15:12
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` Direct lateral, to me, can be a -- a 09:15:15
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` transpsoas approach or a direct transthoracic 09:15:20
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` approach, which I consider basically a 90-degree 09:15:24
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` approach. I also do anterolateral approaches 09:15:29
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` and I do posterolateral approaches to the spine. 09:15:32
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` Posterolateral approaches generally -- 09:15:35
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` well, I've done them in the thoracic region, 09:15:37
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` too. It's costotransversectomies. And I've 09:15:39
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` done them in the lumbar spine. And it's 09:15:40
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` posterolateral approach is more minimally 09:15:43
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` invasive. We're doing TLIF-type procedures. 09:15:46
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` And I do anterolateral approaches, 09:15:50
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` particularly which is coming in relative to the 09:15:50
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` spine in front of the psoas muscle in the lumbar 09:15:56
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` spine, which makes the anterolateral, or in the 09:16:02
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` thoracic spine, which comes in in a manner which 09:16:04
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` is just in front of or ventral to the mid -- 09:16:08
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` midlateral plane. 09:16:14
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` And the reason for that is, as I said, I 09:16:16
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` treat numerous types of conditions, including 09:16:18
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` tumors, fractures, infections, destructive 09:16:23
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` conditions where the spine is unstable, as well 09:16:29
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` as deformity conditions where the spine might be 09:16:31
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` rotated 90 degrees. So in that -- that's why I 09:16:33
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` said you asked me a broad question. 09:16:38
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` I might make an incision from the side of 09:16:40
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` a patient's body, which is a lateral approach, 09:16:42
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` but because the spine is twisted, I end up 09:16:45
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` completely ventral or anterior to the front of 09:16:49
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` the spine if the spine is twisted. 09:16:52
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` So it has to be a combination when I'm -- 09:16:54
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` to answer your question, if you're asking me 09:16:57
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` about a condition, you're asking me about a 09:16:59
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` location of the spine, I can tell you how I 09:17:01
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` might approach that. 09:17:04
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` Q. (By Mr. Schaefer) Okay. So let's talk 09:17:05
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`about the lower lumbar then and interbody fusion. 09:17:07
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`You're familiar with that; right? 09:17:12
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` A. Yes, I am familiar with that. 09:17:14
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` Q. What types of approaches do you currently 09:17:15
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`use to get to the spine in the lumbar region to do an 09:17:17
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`interbody fusion procedure? 09:17:21
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` MR. DAUCHOT: Objection to form. 09:17:23
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` THE WITNESS: As -- I can tell you it's, 09:17:24
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` again, it's not any one particular approach 09:17:28
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` because it depends on the condition. If I'm 09:17:32
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` treating a degenerative spinal condition in the 09:17:34
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` lower part of the lumbar spine, I might very 09:17:38
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` well be going retroperitoneal but anterior 09:17:40
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` direct, anterior approach from the front of the 09:17:44
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` spine, which is behind the peritoneum. 09:17:46
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` I've also done laparoscopic approaches to 09:17:51
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` the front of the spine, which are through small 09:17:55
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` poke holes, which is a transperitoneal approach 09:17:57
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` anteriorly. And I've done direct transpsoas 09:18:00
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` lateral approaches for degenerative disk 09:18:05
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` disease. 09:18:07
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` And if I have a patient with a spine 09:18:07
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` deformity, I will either go anterolateral or 09:18:10
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` posterolateral or directly translateral of the 09:18:16
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` lumbar spine. Again, depending on what the 09:18:19
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` problem is. 09:18:21
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` MR. SCHAEFER: Okay. 09:18:22
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` THE WITNESS: Bless you. 09:18:25
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` Q. (By Mr. Schaefer) We were talking about 09:18:33
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`direct lateral procedures, or what you called 09:18:36
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`90-degree approaches. In your current practice, what 09:18:39
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`systems do you use to perform those? 09:18:46
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` A. If I'm doing a direct lateral approach for 09:18:52
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`a degenerative disk problem, which is a collapsed 09:18:54
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`disk space, and I'm going directly transpsoas, then 09:18:57
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`I've used -- I have used the NuVasive system. I have 09:19:02
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`used the Synthes Oracle system. I've used the DePuy 09:19:06
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`Cougar system. I've used the Globus 09:19:13
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`TransContinental/InterContinental system. I tried 09:19:19
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`the Stryker system one time that I recall. 09:19:23
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` I think that that's the extent of the 09:19:30
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`systems that I've used, if you're talking about that 09:19:33
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`type of an approach. And I've also -- I have also -- 09:19:38
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`again, my practice has evolved over the last 30 09:19:46
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`years -- that's why I have so much gray hair -- and I 09:19:51
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`was -- years ago, in developing, trying to develop 09:19:54
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`techniques for doing lateral approaches to the spine 09:20:02
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`and performing those approaches with different tools 09:20:06
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`and with different techniques. 09:20:11
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` So when you're talking about a system, the 09:20:14
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`system that I was using was really a composite system 09:20:16
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`that used implants and instruments, I should say, 09:20:20
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`instruments from -- that were manufactured by 09:20:25
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`Surgical Dynamics and U.S. Surgical and Ethicon 09:20:30
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`Surgical and Johnson & Johnson Surgical. So I've 09:20:34
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`used those systems as well to go a lateral approach 09:20:38
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`to the lumbar spine. 09:20:43
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` Q. In those that you're talking about, what 09:20:44
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`time frame are you using those types of procedures? 09:20:47
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` A. I started to develop -- again, I was 09:20:54
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`working on developing those techniques, which was -- 09:20:57
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`or what I would say a laparoscopic in the lumbar 09:21:01
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`spine or thoracoscopic approach in the thoracic 09:21:07
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`spine, trying to do the approaches that I was doing, 09:21:10
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`that I had been doing through a large incision, but 09:21:15
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`performing them when I was at Tufts New England 09:21:18
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`Medical Center working with cadavers and working in 09:21:23
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`an animal lab. That's when I first started 09:21:27
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`developing those techniques and working with those 09:21:31
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`instruments and those particular -- that equipment 09:21:32
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`that I was just referencing. 09:21:38
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` And when I first started actually working 09:21:39
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`with people, when I did the procedure on people, it 09:21:42
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`was after I had moved to the Albany Medical Center. 09:21:44
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` Q. Okay. I understand. We'll probably talk 09:21:47
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`about that a little bit more in a bit. But currently 09:21:50
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`now if you were to do a lateral procedure, what 09:21:53
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`manufacturer's equipment would you use? 09:22:02
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` MR. DAUCHOT: Objection to form. 09:22:04
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` THE WITNESS: Again, are you -- which -- a 09:22:07
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` lateral procedure of what area of the spine, for 09:22:11
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` what problem, and what -- 09:22:14
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` Q. (By Mr. Schaefer) Let's take a direct -- 09:22:18
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`you want to do a direct lateral approach in the 09:22:20
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`lumbar spine. What equipment would you presently 09:22:22
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`use? 09:22:27
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` A. If I'm treating a degenerative disk 09:22:28
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`problem in the lumbar spine or even a degenerative 09:22:30
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`probably deformity scoliosis in the lumbar spine in a 09:22:36
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`patient, and I'm doing a -- as a transpsoas-type 09:22:40
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`approach, then probably the -- my preferred equipment 09:22:45
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`right now would be the Globus system, and a second 09:22:53
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`backup would be the -- either the Cougar system by 09:22:57
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`DePuy or the Synthes Oracle system. 09:23:01
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` Q. Why are those your preferred systems? 09:23:09
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` A. Because I, number one, I'm familiar with 09:23:13
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`the equipment and I like the equipment. I find it 09:23:18
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`fairly easy to use. And, secondly, because I get 09:23:21
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`very good support and service from the local 09:23:26
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`representatives in the area to be -- to provide the 09:23:28
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`equipment and provide the tools and any other extra 09:23:33
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`additional instruments that I might need during the 09:23:37
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`surgery. 09:23:39
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` Q. Okay. 09:23:40
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` A. What I refer to with them as value-added 09:23:41
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`service. 09:23:45
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` Q. You mentioned the NuVasive X-LIF system; 09:23:45
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`right? 09:23:53
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` A. Yes, sir. 09:23:53
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` Q. And you have performed X-LIF procedures; 09:23:54
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`right? 09:23:57
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` A. Yes, sir. 09:23:57
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` Q. When did you start doing -- when did you 09:23:58
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`first do an X-LIF procedure? 09:24:00
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` A. The first time I did an X-LIF procedure 09:24:03
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`was when I was at the Texas Back Institute in my 09:24:05
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`practice before Medical University of South Carolina. 09:24:10
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`I had been here for five years. So it was more than 09:24:17
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`five years ago, somewhere in the mid-2000 -- 2000 09:24:20
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`range. 09:24:26
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` Q. Mid-2000? 09:24:26
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` A. Somewhere in there. 09:24:28
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` Q. And at some point you did training at 09:24:28
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`NuVasive for that procedure? 09:24:32
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` A. I'm not sure I ever did -- I don't believe 09:24:33
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`I did go to NuVasive for training for that procedure. 09:24:35
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` Q. How were you trained on that system? 09:24:38
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` MR. DAUCHOT: Objection. Relevance. 09:24:42
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` THE WITNESS: I don't -- you know, I'm 09:24:44
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` not -- I don't -- I don't remember. I know I -- 09:24:49
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` I didn't go to NuVasive. And I believe there 09:24:51
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` might have been a training course that we had at 09:24:55
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` Texas Back Institute because I learned how to do 09:24:57
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` it as well as a number of my partners. And I 09:25:04
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` think that a course was provided for us at TBI. 09:25:07
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` When I was at Texas Back Institute, I also 09:25:13
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` organized and set up a medical conference 09:25:15
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` center. It was a cadaver lab that we had which 09:25:21
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` was used for education and used for surgical 09:25:25
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` training. 09:25:28
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` So we had a number of different courses 09:25:30
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` that -- some that I organized, some that -- that 09:25:31
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` corporate industry would come in and support and 09:25:36
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` put on. And it could have very well been a 09:25:39
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` course like that. But I know I didn't go to 09:25:43
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` California. 09:25:47
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` Q. (By Mr. Schaefer) Approximately how many 09:25:47
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`X-LIF procedures have you performed? 09:25:50
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` A. Using the actual equipment from NuVasive? 09:25:51
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`Is that what you're asking me? 09:25:56
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` Q. Yes. 09:25:58
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` A. Approximately six, half a dozen. 09:25:58
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` Q. When's the last time you did an X-LIF 09:26:01
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`procedure using NuVasive equipment? 09:26:08
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` A. It was when I was at the Texas Back 09:26:09
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`Institute. So it was more than five years ago. 09:26:12
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` Q. Did you do an X-LIF procedure using 09:26:14
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`NuVasive's CoRoent implant? 09:26:21
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` A. I can -- I used the NuVasive implant. I 09:26:26
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`used the NuVasive retractor system. And I used the 09:26:30
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`NuVasive monitoring system. Everything about 09:26:34
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`NuVasive, except for the tools that I used to work 09:26:38
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`and clean out the disk and move around. 09:26:43
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` So the answer to your question is I don't 09:26:46
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`know if it was a CoRoent implant or what it actually 09:26:49
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`was at this point in time. I couldn't tell you. I'm 09:26:53
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`sorry. But the implant that I put in was provided to 09:26:56
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`me by NuVasive coming out of a NuVasive tray with a 09:26:59
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`NuVasive rep there. 09:27:03
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` Q. When was the last time you saw an X-LIF 09:27:06
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`procedure performed? 09:27:14
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` MR. DAUCHOT: Objection. Relevance. 09:27:18
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` THE WITNESS: It was -- the last time I 09:27:22
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` saw a live X-LIF was actually -- you know, I can 09:27:25
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` answer that. I don't know the exact date, but 09:27:29
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` one of the neurosurgeons performs X-LIFs at 09:27:34
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` Medical University of South Carolina. And he's 09:27:39
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` called me into the room at least on one occasion 09:27:43
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` where I -- so I observed part of his procedure, 09:27:47
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` not the full procedure. So that would have been 09:27:50
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` the last time that I saw it. 09:27:53
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` Q. (By Mr. Schaefer) And when would that have 09:27:55
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`been? 09:27:57
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` A. Probably two, two or three years ago. 09:27:57
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` Q. I want to take this time to put your 09:27:59
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`declarations in front of you that you submitted in 09:28:16
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`this case. 09:28:18
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` MR. SCHAEFER: So the first exhibit I'm 09:28:49
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` going to hand you is Exhibit 2038 from 09:28:50
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` IPR2013-00208. 09:29:00
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` (Deposition Exhibit 2038 was marked for 09:29:06
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` identification.) 09:29:11
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` MR. SCHAEFER: And the second exhibit I'm 09:29:11
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` going to hand you is Exhibit 2038 also, but this 09:29:12
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` is from IPR2013-00206. 09:29:16
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` (Deposition Exhibit 2038 was marked for 09:29:22
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` identification.) 09:29:31
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` Q. (By Mr. Schaefer) And these are the 09:29:31
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`declarations that had been submitted to the Patent 09:29:35
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`Office in the various procedures. Do you recognize 09:29:38
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`the documents? 09:29:42
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` A. On the basis of a brief perusal and 09:29:44
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`looking at the table of contents and the page numbers 09:30:12
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`and some of the information that is here, yes, they 09:30:15
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`appear to be the declarations that -- that I'm 09:30:18
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`familiar with and that I submitted. 09:30:23
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` Q. Okay. From my review, these two 09:30:26
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`declarations are exactly the same in terms of the 09:30:31
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`testi

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