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` Charles L. Branch, Jr., MD.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ALPHATEC HOLDINGS, INC.,
` AND ALPHATEC SPINE, INC., Case No:
` Petitioner, IPR2019-00361
` vs. United States Patent
` NUVASIVE, INC., No. 8,187,334
` Patent Owner
`
` Deposition of Charles L. Branch, Jr., MD.
` Tuesday, September 24, 2019
` At 9:00 a.m.
` Charlotte, North Carolina
`
` REVISED
`
`Reported by LeShaunda Cass-Byrd, CSR, RPR
`TSG Job No. 168221
`
`TSG Reporting - Worldwide 877-702-9580
`
`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
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`Page 1
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` Charles L. Branch, Jr., MD.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ALPHATEC HOLDINGS, INC.,
` AND ALPHATEC SPINE, INC., Case No:
` Petitioner, IPR2019-00361
` vs. United States Patent
` NUVASIVE, INC., No. 8,187,334
` Patent Owner
`
` Deposition of Charles L. Branch, Jr., MD.
` Tuesday, September 24, 2019
` At 9:00 a.m.
` Charlotte, North Carolina
`
` REVISED
`
`Reported by LeShaunda Cass-Byrd, CSR, RPR
`TSG Job No. 168221
`
`TSG Reporting - Worldwide 877-702-9580
`
`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`
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`Page 2
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` Charles L. Branch, Jr., MD.
`
`APPEARANCES OF COUNSEL:
`
`On behalf of Nuvasive Inc.:
`
` JAD MILLS, Esq
` SONJA GERRARD, Esq.
` Wilson Sonsini Goodrich & Rosati
` 701 Fifth Avenue
` Seattle, Washington 98104
`
`On behalf of Alphatec Holdings, Inc.,:
` NIMALKA WICKRAMASEKERA, Esq.
` DAVID DALKE, Ph.D., Esq.
` Winston & Strawn
` 333 South Grand Avenue
` Los Angeles, California 90071
`
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`IPR2019-00361
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` Charles L. Branch, Jr., MD.
` EXAMINATION OF CHARLES BRANCH, JR., M.D.,
` By Mr. Mills 4
` DEPOSITION EXHIBITS
` EXHIBIT DESCRIPTION PAGE
` Exhibit 2021 Sketch 117
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`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` Charles L. Branch, Jr., MD.
` CHARLES BRANCH, JR., M.D.,
` having been first duly sworn, was examined and
` testified as follows:
` EXAMINATION
` BY MR. MILLS: 09:07:32
` Q. Good morning. Can you please state your 09:07:32
` name for the record? 09:07:36
` A. Charles L. Branch, Jr. 09:07:38
` Q. It's Dr. Branch, correct? 09:07:39
` A. Correct. 09:07:41
` Q. Dr. Branch, have you been deposed before? 09:07:41
` A. Yes. 09:07:44
` Q. How many times have you been deposed 09:07:44
` before? 09:07:46
` A. Several. 09:07:49
` Q. When was your most recent deposition? 09:07:50
` A. A year ago. 09:07:51
` Q. I may not go through all the ground rules, 09:07:56
` but I will go through a bit of a refresher, if that is 09:08:00
` all right. So from your last deposition, you probably 09:08:03
` recall it's very important that we speak only one at a 09:08:05
` time. Okay? 09:08:08
` A. Yes. 09:08:10
` Q. And that counsel has to think about that as 09:08:11
`
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`IPR2019-00361
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` well. It's something we forget probably even more 09:08:14
` than the witnesses. 09:08:17
` You understood you just took an oath. So 09:08:18
` it's very important that you tell the truth, to the 09:08:22
` best of your ability today. 09:08:26
` Do you understand that? 09:08:28
` A. Yes, I do. 09:08:29
` Q. Is there any reason that you would not be 09:08:30
` able to give the full and true testimony to the best 09:08:31
` of your ability today? 09:08:34
` A. No. 09:08:36
` Q. For example, if you were under the 09:08:36
` influence of any medication or something like that, 09:08:38
` that would impair your ability to testify? 09:08:41
` A. No medicines. 09:08:44
` Q. Okay. If the attorney sitting next to you 09:08:48
` lodges any objections at any point, that doesn't 09:08:51
` excuse you from answering any question. 09:08:54
` Do you understand that? 09:08:56
` A. Yes. 09:08:57
` Q. If you'd like to take a break, you are 09:08:57
` perfectly welcome to take breaks. I will try and take 09:09:01
` breaks every once and a while. If you want a break, 09:09:04
` you just need to say something. But I will ask that 09:09:06
`
`TSG Reporting - Worldwide 877-702-9580
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`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` we not take a break when I've posed a question before 09:09:08
` you've answered the question. 09:09:10
` Is that acceptable to you? 09:09:12
` A. Understood. 09:09:14
` Q. Okay. And you understand that I represent 09:09:20
` Nuvasive, Inc., the patent owner in these proceedings, 09:09:24
` correct? 09:09:26
` A. I do. 09:09:27
` Q. And you understand this deposition today is 09:09:27
` for the IPR proceedings, correct? 09:09:29
` A. Yes. 09:09:31
` Q. You understand that there are three IPR 09:09:32
` proceedings? 09:09:34
` A. Yes. 09:09:34
` Q. And those relate to two patents, correct? 09:09:35
` A. Correct. 09:09:37
` Q. Do you remember which patents? 09:09:38
` A. The last three numbers '156 and '334. 09:09:39
` Q. Okay. And you submitted declarations in 09:09:42
` those three IPRs relating to those two patents, 09:09:47
` correct? 09:09:52
` A. I did. 09:09:52
` Q. Those declarations that you submitted, 09:09:52
` reflected all of your opinions that you have for these 09:09:58
`
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`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` IPRs; is that correct? 09:10:01
` A. Yes. 09:10:02
` Q. In reviewing your declaration, I noticed 09:10:10
` that there is substantial overlap between much of the 09:10:13
` material in the declarations. Do you recall that? 09:10:17
` A. Yes. 09:10:18
` Q. And so when we are discussing the material, 09:10:19
` are you comfortable with us discussing it once, or do 09:10:23
` you want to discuss it three times? 09:10:27
` A. I think whatever we need to do to make sure 09:10:28
` that I give you the most accurate deposition 09:10:31
` testimony. 09:10:33
` Q. Okay. If we are ever discussing anything 09:10:33
` with relation to one of the references or one of the 09:10:37
` declarations and you think that the answer would be 09:10:40
` different for one of your other declarations, if you 09:10:42
` can let us know. Is that all right? 09:10:45
` A. Yes. 09:10:47
` Q. How did you prepare for your deposition 09:10:47
` today? 09:10:50
` A. I read my declaration and the source 09:10:50
` material patents that are in question. I think other 09:10:55
` material petitions and the patent owners' responses, 09:11:04
` some material that I think was pertinent to the 09:11:08
`
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`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` declaration. 09:11:11
` Q. So you said you read your declaration. Did 09:11:12
` you read one of them, or did you read all three of 09:11:16
` them? 09:11:18
` A. I read all three. 09:11:18
` Q. Okay. You said you read the patent owner 09:11:19
` responses. Did you read one of them or did you read 09:11:23
` all three? 09:11:26
` A. All three. 09:11:26
` Q. You said you read other material that you 09:11:27
` thought was pertinent to the declaration. Can you 09:11:31
` tell me what that was? 09:11:33
` A. The petitions that apparently resulted in 09:11:35
` this IPR, or this whatever we call it, IPR. Okay. 09:11:41
` And then the patents themselves that I used, one of 09:11:46
` the '334 and '156 patents, and then the patents that I 09:11:50
` based my opinions on in my declaration. 09:11:56
` Q. Okay. So you have mentioned the petitions, 09:12:00
` the patent owner preliminary responses, the patents at 09:12:05
` issue in the prior art references; is that right so 09:12:10
` far? 09:12:13
` A. Yes. 09:12:13
` Q. Other than those things, was there anything 09:12:13
` else that you reviewed in preparation for your 09:12:16
`
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`IPR2019-00361
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` deposition today? 09:12:17
` A. Not that I recall. 09:12:18
` Q. Did you speak with anyone in preparation 09:12:21
` for your deposition? 09:12:23
` A. I had conferences with my attorneys. 09:12:26
` Q. And are those the two attorneys that are in 09:12:28
` room right now? 09:12:31
` A. Yes. 09:12:31
` Q. When did you most recently have a 09:12:32
` conference in preparation for your deposition? 09:12:36
` A. We -- I guess before we walked in the room, 09:12:38
` we were talking together. But we met yesterday, and 09:12:42
` several times over the summer, I guess. 09:12:48
` Q. When you met yesterday, how long did you 09:12:50
` meet? 09:12:52
` A. Six hours. 09:12:52
` Q. And other than the two attorneys who are in 09:12:56
` the room right now, was anyone else participating in 09:13:01
` those meetings? 09:13:03
` A. No. 09:13:04
` Q. Was anyone else present at those meetings? 09:13:04
` A. No. 09:13:07
` Q. Did anyone call in to those meetings? 09:13:08
` A. Not that I'm aware of. 09:13:10
`
`TSG Reporting - Worldwide 877-702-9580
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`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` Q. You said just a moment ago that you also 09:13:12
` had some preparation meetings with counsel over this 09:13:14
` summer. Do you recall that? 09:13:17
` A. Yes. 09:13:18
` Q. When were those meetings? 09:13:18
` A. Late August and early September. The dates 09:13:20
` I can't remember, but that was the time frame. 09:13:28
` Q. Is it correct that there were two meetings 09:13:30
` over the summer? 09:13:33
` A. Yes. 09:13:33
` Q. The meeting in September, where did that 09:13:33
` take place? 09:13:35
` A. Los Angeles. 09:13:36
` Q. And how long did that meeting last? 09:13:37
` A. Six, seven hours. 09:13:39
` Q. Is it correct that the only people that 09:13:44
` were present at that meeting are the two attorneys 09:13:46
` that are sitting in the room today? 09:13:48
` A. Yes. 09:13:49
` Q. You mentioned an earlier meeting over the 09:13:50
` summer. Where did that take place? 09:13:52
` A. Los Angeles. 09:13:54
` Q. And who was present at that meeting? 09:13:56
` A. Mr. Dalke and the two attorneys that are in 09:13:58
`
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`IPR2019-00361
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` room right here. 09:14:07
` Q. Other than the two attorneys that are in 09:14:08
` the room here today, have you spoken with anyone else 09:14:10
` ever about this case? 09:14:13
` A. Not that I recall. 09:14:19
` Q. You are a medical doctor? 09:14:20
` A. Yes. 09:14:24
` Q. You are a neurosurgeon? 09:14:24
` A. Yes. 09:14:27
` Q. You are not an orthopaedic surgeon? 09:14:28
` A. That is correct. 09:14:32
` Q. What is the difference between an 09:14:33
` orthopaedic surgeon and a neurosurgeon? 09:14:38
` A. We train with a different focus. We both 09:14:39
` complete our medical degree. Neurosurgeons then have 09:14:42
` subsequent training that focuses on treatment of the 09:14:46
` brain and spine and spinal cord, and it's the primary 09:14:48
` focus. Trauma disease, degenerative disease, vascular 09:14:53
` disease of the brain, spine and spinal cord. 09:15:00
` Orthopaedic surgeons have a focus that is 09:15:03
` really more on the musculoskeletal system itself, but 09:15:05
` there is some overlap which includes spine and nerves. 09:15:09
` Q. You have experienced with minimally 09:15:12
` invasive lumbar interbody fusion techniques, correct? 09:15:26
`
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` A. Yes. 09:15:30
` Q. What is a lumbar interbody fusion? 09:15:36
` A. It's -- it describes a technique for 09:15:39
` replacing the disc or shock absorber or cushion 09:15:47
` between two vertebra that has either become diseased 09:15:53
` or injured and is causing some pathology, injury to 09:15:56
` the surrounding nerves or supporting structures of the 09:16:06
` spine. We replace that injured diseased disc with 09:16:10
` bone and support devices that promote growth of the 09:16:19
` two vertebra together. 09:16:23
` Lumbar is the lumbar spine. So we are 09:16:28
` talking about two vertebra in the lumbar spine. 09:16:30
` Interbody is the bone graft and support devices are in 09:16:34
` between the two vertebra. Fusion, the goal of the 09:16:38
` technique is to actually take two moving segments and 09:16:41
` consolidate them into one, and biologically joined or 09:16:46
` fused. 09:16:51
` Q. You agree that the claims at issue in these 09:16:52
` IPR proceedings are directed to interbody fusion 09:16:55
` implants? 09:17:00
` A. Yes. 09:17:01
` Q. You said that in an interbody fusion 09:17:14
` technique, that the interbody fusion implant is 09:17:16
` between the two vertebra bodies; is that correct? 09:17:22
`
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` A. Correct. 09:17:25
` Q. Is it -- is it correct that the interbody 09:17:26
` fusion technique, the interbody fusion implant should 09:17:33
` not exceed the footprint of the two adjacent vertebral 09:17:36
` bodies? 09:17:46
` A. It may exceed, but shouldn't in a way that 09:17:46
` injure surrounding tissue. 09:17:50
` Q. So what surrounding tissues do you have in 09:17:51
` mind? 09:17:53
` A. Well, there are some large blood vessels, 09:17:54
` the distal aorta or iliac arteries, the large vein, 09:17:56
` the vena cava or iliac veins, and then there are 09:18:04
` nerves, individual nerves that leave the spine, and 09:18:09
` call them spinal nerves, or the consolidated nerves 09:18:12
` into these called plexus, that we call the lumbar 09:18:16
` plexus. 09:18:21
` There are some other nerves that are really 09:18:22
` closer to the spine that we call the autonomic nervous 09:18:24
` system as well. So nerves and blood vessels are the 09:18:29
` main concerns, although there are abdominal organs, 09:18:32
` the ureter and other structures in the abdomen that 09:18:40
` are a little more removed from the vertebra that are 09:18:43
` certainly things that we don't want to injure doing 09:18:46
` interbody fusion. 09:18:49
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` Charles L. Branch, Jr., MD.
` Q. Is it correct that the tissues that you 09:19:00
` have to be careful about performing interbody fusion 09:19:02
` depend on the portion of the spine which you are 09:19:05
` performing the fusion technique? 09:19:07
` A. Those structures that I've mentioned, 09:19:09
` nerves, blood vessels, in particular, are a concern 09:19:14
` from cervical to lumbar. But as we move from the 09:19:20
` abdomen or lumbar spine to the thoracic spine, those 09:19:23
` other surrounding structures change from ureter and 09:19:28
` bowel to lungs and -- lungs in particular, or in the 09:19:32
` cervical spine, the esophagus or the windpipe or 09:19:36
` trachea. 09:19:42
` Q. And you personally perform the cervical 09:19:42
` interbody fusion implant technique? 09:19:44
` A. Yes. 09:19:48
` Q. When was the first time you performed 09:19:54
` cervical implant technique? 09:19:57
` A. 1986. 09:20:00
` Q. What was the surgical approach you used 09:20:01
` when you first performed the cervical implant 09:20:09
` technique? 09:20:11
` A. We call them anterior cervical discectomy 09:20:11
` infusion, and that involved making an incision in the 09:20:15
` neck, usually in the skin crease, finding the plane 09:20:23
`
`TSG Reporting - Worldwide 877-702-9580
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`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` Charles L. Branch, Jr., MD.
` between the tracheoesophageal structures which are in 09:20:28
` the midline and the carotid and jugular -- artery and 09:20:33
` jugular vein, which are off finding a plane between 09:20:36
` those two, separating them, visualizing the spine or 09:20:39
` the -- what we call the ventral cervical spine and 09:20:42
` then removing a disc and replacing it with a bone 09:20:45
` graft or implant with bone graft inside it. 09:20:53
` Q. You used the word anterior or cervical 09:20:58
` discectomy? 09:21:01
` A. Yes. 09:21:02
` Q. You used the word anterior. That means 09:21:02
` that you are coming from the front of the person's 09:21:05
` body; is that correct? 09:21:07
` A. That is correct. 09:21:08
` Q. Have you ever performed a cervical 09:21:09
` interbody fusion technique from an approach other than 09:21:12
` an anterior approach? 09:21:17
` A. No. 09:21:18
` Q. Have you ever performed a thoracic 09:21:23
` interbody fusion technique? 09:21:25
` A. Yes. 09:21:26
` Q. How did you -- let me withdraw that and 09:21:26
` start over. 09:21:30
` When did you first perform a thoracic 09:21:30
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`TSG Reporting - Worldwide 877-702-9580
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`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` interbody fusion? 09:21:33
` A. That was probably more in the -- in the 09:21:34
` early '90s. I would say after I completed my 09:21:36
` training. It's '89 or '90, somewhere in that time 09:21:40
` frame. 09:21:44
` Q. What approach? 09:21:44
` A. 1989. 1990. 09:21:45
` Q. What approach did you use for that 09:21:47
` procedure? 09:21:49
` A. A -- I can't recall whether the first one 09:21:49
` was a transthoracic approach, where we actually 09:21:55
` separated the ribs, deflated the lung on the side that 09:21:59
` we were entering, and then once the lung is deflated, 09:22:02
` then it gave us access to the disc space, which we 09:22:06
` then removed the disc and put a graft in. 09:22:09
` Another technique that I've used is more 09:22:12
` posterior, that we call a costotransversectomy, in 09:22:15
` which the approach is more posterior, and we remove 09:22:19
` part of the rib, lift the muscles away from the spine. 09:22:25
` Again, we don't deflate the lung as much, and then put 09:22:31
` a graft in the disc space. Both of those were 09:22:34
` techniques that I began to use in the early 1990s. 09:22:39
` Q. Other than the two approaches you just 09:22:44
` mentioned, are there other approaches that you've used 09:22:47
`
`TSG Reporting - Worldwide 877-702-9580
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`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` for a thoracic interbody fusion technique? 09:22:49
` A. Maybe more recently what we call a 09:22:57
` transpedicular approach. It's a little more 09:23:01
` posterior. And if I can orient you, the transthoracic 09:23:02
` approach, generally, is very lateral. The patient is 09:23:07
` laying on the side, we separate the ribs, deflate the 09:23:09
` lung, and move it out of the way and come in from a 09:23:13
` true lateral approach. 09:23:17
` The costotransversectomy allows me to come 09:23:17
` in what we call posterolateral, angled in from the 09:23:18
` posterior approach into the disc space. The 09:23:23
` transpedicular approach, which is, I think, what I am 09:23:26
` doing more now, is more posterior. But by removing 09:23:30
` the pedicle or one of the support structures of the 09:23:38
` spine, I can actually access the disc space, do my 09:23:41
` interbody fusion with less risk of injury to the lung, 09:23:44
` ribs, intercostal nerves, and yet, being very 09:23:50
` conscious to avoid injury to the spinal cord. So that 09:23:55
` is a more posterior. 09:23:58
` So I've given you three approaches that go 09:24:01
` from lateral, posterolateral and posterior. 09:24:04
` Q. Approximately, when was the first time that 09:24:06
` you performed the posterior transpedicular approach? 09:24:08
` A. Probably 10 years ago. 09:24:12
`
`TSG Reporting - Worldwide 877-702-9580
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`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` Charles L. Branch, Jr., MD.
` Q. When, approximately, was the first time you 09:24:19
` performed the posterolateral -- 09:24:21
` A. Costotransversectomy was in -- that was, 09:24:24
` again, back in the early '90s. 09:24:25
` Q. Approximately, when was the first time that 09:24:46
` you performed the transthoracic lateral approach? 09:24:49
` A. That would have been the same, the early 09:24:52
` '90s as well. 09:24:53
` Q. And that was for a thoracic vertebra, 09:24:55
` correct? 09:24:59
` A. Correct. Yes, sir. 09:24:59
` Q. When was the first time you performed an 09:25:01
` interbody fusion technique for lumbar vertebra? 09:25:06
` A. That was about 1986 as well. '85 or '86. 09:25:09
` Q. What approach did you use? 09:25:18
` A. What we would call a traditional posterior 09:25:19
` bilateral PLIF. PLIF is the acronym for posterior 09:25:25
` lumbar interbody infusion, implies or imparts an 09:25:31
` exposure posteriorly in the midline, where the skin 09:25:38
` and the muscles are pulled away from the spine. 09:25:43
` The roof of the spine is removed, or what 09:25:45
` we call a laminectomy, and then the space between the 09:25:47
` dura sac, which houses the nerves, and the edge of the 09:25:57
` spinal canal, or the pedicle is identified as part of 09:25:59
`
`TSG Reporting - Worldwide 877-702-9580
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`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` Charles L. Branch, Jr., MD.
` the pedicle or facet joint is removed. 09:26:03
` And then from the posterior approach 09:26:06
` through the foramen, we remove the disc material on 09:26:09
` each side of the spine -- on each side of the dural 09:26:13
` sac. 09:26:13
` And then after removing that material, 09:26:18
` repack the disc space with, at that time, bone graft, 09:26:21
` a bone graft that was taken from the bone bank, or 09:26:26
` what we call allograft or donor bone, and then with my 09:26:30
` father, I developed a technique where we actually 09:26:38
` put -- took the bone from the laminectomy, or we 09:26:40
` removed the bone off the roof and packed that bone 09:26:44
` into the disc space so that we didn't have to use 09:26:47
` donor bone allograft bone. 09:26:50
` And that was a development project from '86 09:26:54
` through '89 or '90, and that was my earliest posterior 09:26:57
` lumbar interbody fusion work. 09:27:07
` Q. When you were discussing performing a 09:27:09
` cervical interbody fusion technique in 1986, is that 09:27:12
` using bone material or was that using non-bone 09:27:18
` material? 09:27:21
` A. Using bone material. 09:27:21
` Q. And the same question for your thoracic 09:27:22
` interbody fusion techniques in early 1990s, was that 09:27:28
`
`TSG Reporting - Worldwide 877-702-9580
`
`NUVASIVE - EXHIBIT 2022
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00361
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` Charles L. Branch, Jr., MD.
` using bone material? 09:27:31
` A. I believe it was. It was -- in fact, it 09:27:32
` was donor bone or allograft bone. 09:27:36
` Q. Approximately, when was the first time you 09:27:39
` performed interbody fusion technique using a non-bone 09:27:41
` implant? 09:27:45
` A. 1999 or 2000. '98 to 2000, in that range. 09:27:50
` Q. What implant was
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