`15
`
`EXHIBIT 23
`
`DECLARATION OF TRENT D. TANNER
`IN SUPPORT OF
`NUVASIVE'S OPPOSITION TO
`DEFENDANTS' MOTIONS IN LIMINE NOS. 1-10
`
`
`
`
`
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`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32575 Page 2 of
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
`
`Case No. 18-cv-00347-MDD-CAB
`
`)))))))))))))
`
`NUVASIVE, INC., a Delaware corporation,
` Plaintiff,
`v.
`
`ALPHATEC HOLDINGS, INC., a Delaware
`corporation, and ALPHATEC SPINE, INC., a
`California corporation,
` Defendants.
`
`SUPPLEMENT TO EXPERT REPORTS OF JIM YOUSSEF
`
`EXHIBIT 23
`Page 526
`
`
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`At the request of counsel for NuVasive, Inc. (“NuVasive”), I hereby provide the following
`
`supplement to my Corrected Opening Expert Report served November 18, 2019, and Responsive
`
`Expert Report served on November 22, 2019. I reserve the right to amend and/or supplement this
`
`expert report based on my continuing review of the currently available evidence and/or if I am
`
`provided with additional evidence of relevance to the opinions set forth herein.
`
`Narrowing of Asserted Claims
`
`1.
`
`I understand from counsel that the asserted claims have been narrowed since service
`
`of my reports. I understand from counsel that the currently asserted claims are the following:
`
`U.S. Patent No. 7,819,801: 1, 2, 15, 16, and 26
`
`U.S. Patent No. 8,355,780: 21, 22, 24, 25, and 27
`
`U.S. Patent No. 8,439,832: 1, 3, 9, 10, 12, 14, and 16
`
`U.S. Patent No. 9,833,227: 2, 6, 13, 15, 17, 22, and 28
`
`U.S. Patent No. 8,753,270: 1, 2, 3, 6, and 12
`
`U.S. Patent No. 9,924,859: 1, 21, 30, 32, and 36
`
`U.S. Patent No. 9,974,531: 1, 5, 10, 32, and 39
`
`Raymond Patent
`
`2.
`
`Dr. Branch’s opening report did not identify a patent number for the “Raymond”
`
`reference discussed in subsection F regarding U.S. Patent No. 9,924,859. Branch ¶ 1079.
`
`3.
`
`In my rebuttal report, I was informed by counsel to assume Dr. Branch was
`
`discussing U.S. Patent No. 8,622,897 (“Raymond ’897”).
`
`4.
`
`After service of my rebuttal report, I was informed by counsel that Dr. Branch’s
`
`opening report was actually discussing U.S. Patent No. 7,491,168 (“Raymond ’168”).
`
`1
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`EXHIBIT 23
`Page 527
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`
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`5.
`
`I reviewed Raymond ’168. It appears to contain the same disclosure as Raymond
`
`’897. As a result, my opinion with respect to Raymond ’168 is the same as it is for Raymond ’897.
`
`Surgical Notes
`
`6.
`
`After I completed and signed my opening report regarding infringement, I reviewed
`
`Dr. Alleyne’s surgery notes regarding a February 14, 2017 procedure. Those notes were provided to
`
`me by counsel and were labeled ALLEYNE000013-17.
`
`7.
`
`It is my opinion that the Alleyne surgery notes reflect direct infringement of claims 2,
`
`6, 13, 15, 17, 22, and 28 of the ’227 patent and claims 12, 14, and 16 of the ’832 patent. Below are
`
`charts reflecting my analysis.
`
`2
`
`EXHIBIT 23
`Page 528
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`
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`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32578 Page 5 of
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`’832 PATENT CLAIM
`
`DR. ALLEYNE NOTES—PROCEDURE PERFORMED WITH ACCUSED PRODUCTS
`
`[12A] A method for accessing a spinal
`disc of a lumbar spine of a patient;
`
`“Preoperative Diagnosis: L2-3, L3-4, L4-5, L5-S1 lumbar spinal stenosis with instability and scoliosis.”
`[ALLEYNE000013 – ALLEYNE000017 at 013]
`“Postoperative Diagnosis: L2-3, L3-4, L4-5, L5-S1 lumbar spinal stenosis with instability and
`scoliosis.” [Id.]
`“Procedure Performed: Part 1 XLIF L2-3, L3-4, L4-5.” [Id.]
`“the anterior longitudinal ligament, posterior longitudinal ligament, the 30 yard line and the trajectory
`path were then marked at L4-5, L3-4, and L2-3…Incision was carried down through the skin down to
`subcutaneous tissue. The fascia was then entered at L4-5 by using the Metz, blunt dissection down to
`the psoas. The surgeon’s hand was then used to sweep and palpate the iliac crest, the TP as well as the
`disc space.” [Id.]
`
`3
`
`EXHIBIT 23
`Page 529
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32579 Page 6 of
`15
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`’832 PATENT CLAIM
`
`DR. ALLEYNE NOTES—PROCEDURE PERFORMED WITH ACCUSED PRODUCTS
`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`[12B] sequentially inserting a plurality of
`sequentially larger diameter dilators into
`said patient along a lateral, trans-psoas
`path to create a distraction corridor along
`said lateral, trans-psoas path toward a
`targeted spinal disc, wherein an initial
`dilator of said plurality of sequentially
`larger diameter dilators is configured to
`receive an elongate inner element,
`wherein at least one of said elongate inner
`element and said sequential dilators
`comprises a stimulation electrode;
`[12C] outputting electrical stimulation
`from said stimulation electrode of said at
`least one of said elongate inner element
`and said sequential dilators for nerve
`monitoring when said stimulation
`electrode is positioned in said lateral,
`trans-psoas path;
`
`“The patient was then meticulously placed onto the operating table in a lateral decubitus position with
`the right side up.” [Id. at ALLEYNE000013]
`“trajectory path [was] then marked at L4-5, L3-4, and L2-3. Incision was carried down through the skin
`down to subcutaneous tissue. The fascia was then entered at L4-5 by using the Metz, blunt dissection
`down to the psoas.” [Id.]
`“The 1st dilator was placed and the thresholds were then checked and noted to be stable
`circumferentially,…” [Id.]
`“Somatosensory motor evoked potentials being performed by Ms. Christina Brady.” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator which was tested.” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator (“and the 2nd dilator
`was circumferentially tested” [Id. at ALLEYNE000014]) which was tested and the retractor blades were
`then placed over the 2nd dilator. The Squadron retractor was then opened and locked into position and
`secured with the bed mount. This was followed by the placement of the shim, under AP fluoro at L4-5
`followed by an annulotomy that was made after the K-wire and the dilators were removed and the floor
`of the disk space was then tested circumferentially for any thresholds.” [Id. at ALLEYNE000013-14]
`“The patient tolerated the procedure well. At no time were there any alterations in somatosensory and
`motor evoked potentials.” [Id.]
`
`4
`
`EXHIBIT 23
`Page 530
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32580 Page 7 of
`15
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`’832 PATENT CLAIM
`
`DR. ALLEYNE NOTES—PROCEDURE PERFORMED WITH ACCUSED PRODUCTS
`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`[12D] simultaneously advancing a
`posterior-most retractor blade, a cephalad-
`most retractor blade, and a caudal-most
`retractor blade of a three-bladed retractor
`tool along said lateral, trans-psoas path
`and over an exterior of an outermost
`dilator of said plurality of sequentially
`larger diameter dilators, said three-bladed
`refractor tool comprising a blade holder
`assembly and said posterior-most,
`cephalad-most, and caudal-most refractor
`blades attached to said blade holder
`assembly;
`
`[12E] removing said plurality of
`sequentially larger diameter dilators from
`said patient after said posterior-most,
`cephalad-most, and caudal-most retractor
`blades are advanced through the psoas
`muscle, wherein an operative corridor
`along the lateral, trans-psoas path to the
`targeted spinal disc is at least partially
`defined by said posterior-most, cephalad-
`most, and caudal-most retractor blades;
`and
`
`“and the retractor blades were then placed over the 2nd dilator.” [Id.]
`“the Squadron retractor was then opened” [Id.]
`“Squadron retractor was then locked to the bed mount.” [ALLEYNE000013 – ALLEYNE000017 at
`ALLEYNE000014]
`Regarding L2-L3: “The first dilator was placed and thresholds were tested, noted be adequate, K-wire
`was then introduced into the L2-3 disk space followed by the 2nd dilator which was checked
`circumferentially followed by the Squadron retractor blades being placed with the retractor uneventfully
`at L2-3 and opened after it was secured to the bed mount.” [Id.].
`
`“the retractor blades were then placed over the 2nd dilator.” [Id. at ALLEYNE000013]
`The opening and locking of the Squadron retractor was followed by “placement of the shim under the
`AP fluoro at L4-5 followed by an annulotomy that was made after the K-wire and the dilators were
`removed and the floor of the disk space was then tested circumferentially for any thresholds.” [Id. at
`ALLEYNE000014]
`“… followed by the Squadron retractor blades being placed with the retractor uneventfully at L2-3 and
`opened after it was secured to the bed mount. Once this was accomplished, the 1st and 2nd dilators were
`removed, K-wire was left in place.” [Id.].
`
`5
`
`EXHIBIT 23
`Page 531
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32581 Page 8 of
`15
`
`’832 PATENT CLAIM
`
`DR. ALLEYNE NOTES—PROCEDURE PERFORMED WITH ACCUSED PRODUCTS
`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`[12F] maintaining said operative corridor
`along said lateral, trans-psoas path using
`said three-bladed retractor tool while
`delivering a spinal implant to a disc space
`of the targeted spinal disc.
`
`[14A] The method of claim 13, wherein
`said blade holder assembly is adjustable
`to move each of the cephalad-most and
`caudal-most retractor blades away from
`the posterior-most retractor blade while
`the posterior-most refractor blade remains
`in a generally stationary position relative
`to the targeted spinal disc.
`
`[16A] The method of claim 12, further
`comprising activating a light emitting
`device to direct light through said
`operative corridor toward the targeted
`spinal disc, the light emitting device being
`coupled to one of the posterior-most,
`cephalad-most, and caudal-most blades.
`
`“the Squadron retractor was then opened” [Id.]
`“15 blade was used to make a rectangular incision in to the anulus on the right side followed by pituitary
`rongeur to remove disc material and annular debris. The trial was then used. We used an 8 x 18 x 55
`trial filled with DBM putty and BMP prior to placing are cage (implant).” [Id.]
`“… the implant was then placed from Alphatec using the impacted with the impactor mallet noted to be
`in good position and our attention was then taken to L2-3.” [Id.].
`“… we used an 8 x 18 x 50 filled with BMP and DBM putty. Impacted with the impactor mallet. Prior
`to doing this, the disc space at L2-3 was scraped, rasped, and further disc debris was removed followed
`by disc space irrigation and suctioning of that disk space. With the cage now in place L2-3
`intraoperative AP and lateral fluoro confirmed the position and orientation at all 3 levels.” [Id.].
`
`“Squadron retractor was then opened.” [Id.]
`See Youssef Opening Report re function of Squadron retractor.
`
`“… [r]etractor blades were then placed over the 2nd dilator and the lights were then inserted.” [Id. at
`ALLEYNE000013].
`“… [r]etractor blades were then inserted. Once this was accomplished, the light was then turned on.”
`[Id. at ALLEYNE000014].
`
`6
`
`EXHIBIT 23
`Page 532
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32582 Page 9 of
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`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`’227 PATENT CLAIM
`
`Not Asserted – Asserted Claims Depend From
`Claim 1
`[1A] A method for forming an operating corridor
`to a lumbar spine of a patient, the patient having
`an anterior aspect, a posterior aspect and two
`lateral aspects, the method comprising:
`
`Not Asserted – Asserted Claims Depend From
`Claim 1
`[1B] inserting a plurality of dilators into the
`patient at an insertion position on one of the two
`lateral aspects of the patient, the plurality of
`dilators comprising a first dilator having a first
`diameter and a second dilator having a second
`diameter, the first diameter being smaller than the
`second diameter;
`[1C] advancing the plurality of dilators along a
`lateral, trans-psoas path to a lateral aspect of a
`target intervertebral disc of the lumbar spine, the
`lateral, trans-psoas path having a path axis that
`extends from the insertion position on the one of
`the two lateral aspects to the other of the two
`lateral aspects of the patient, to create a tissue
`distraction corridor along the lateral, transpsoas
`path through a region of a psoas muscle
`
`DR. ALLEYNE NOTES
`
`“Preoperative Diagnosis: L2-3, L3-4, L4-5, L5-S1 lumbar spinal stenosis with instability and
`scoliosis.” [ALLEYNE000013 – ALLEYNE000017 at ALLEYNE000013]
`“Postoperative Diagnosis: L2-3, L3-4, L4-5, L5-S1 lumbar spinal stenosis with instability and
`scoliosis.” [Id.]
`“Procedure Performed: Part 1: XLIF L2-3, L3-4, L4-5.” [Id.]
`“the anterior longitudinal ligament, posterior longitudinal ligament, the 30 yard line and the
`trajectory path were then marked at L4-5, L3-4, and L2-3. Incision was carried down through
`the skin down to subcutaneous tissue. The fascia was then entered at L4-5 by using the Metz,
`blunt dissection down to the psoas. The surgeon’s hand was then used to sweep and palpate the
`iliac crest, the TP as well as the disc space.” [Id.]
`
`“The patient was then meticulously placed onto the operating table in a lateral decubitus
`position with the right side up.” [Id.]
`“trajectory path [was] then marked at L4-5, L3-4, and L2-3. Incision was carried down through
`the skin down to subcutaneous tissue. The fascia was then entered at L4-5 by using the Metz,
`blunt dissection down to the psoas.” [Id.]
`“The 1st dilator was placed and the thresholds were then checked and noted to be stable
`circumferentially,…” [Id.]
`“Somatosensory motor evoked potentials being performed by Ms. Christina Brady.” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator which was
`tested.” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator (“and the 2nd
`dilator was circumferentially tested” [Id. at ALLEYNE000014]) which was tested and the
`retractor blades were then placed over the 2nd dilator. The Squadron retractor was then opened
`and locked into position and secured with the bed mount. This was followed by the placement
`of the shim, under AP fluoro at L4-5 followed by an annulotomy that was made after the K-
`wire and the dilators were removed and the floor of the disk space was then tested
`7
`
`EXHIBIT 23
`Page 533
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32583 Page 10 of
`15
`
`’227 PATENT CLAIM
`containing nerves to the target intervertebral disc,
`the tissue distraction corridor negotiating past the
`nerves of the psoas muscle;
`[1D] electrically stimulating, using a stimulation
`electrode along a distal region of a dilator of the
`plurality of dilators, the nerves of the psoas
`muscle for monitoring a nerve response, and
`advancing the dilator along the lateral, trans-
`psoas path, based on the monitoring, to avoid
`directly contacting the nerves of the psoas
`muscle;
`
`Not Asserted – Asserted Claims Depend From
`Claim 1
`[1E] moving a plurality of retractor blades along
`the lateral, trans-psoas path to form an operative
`corridor along the lateral, trans-psoas path; and
`
`Not Asserted – Asserted Claims Depend From
`Claim 1
`[1F] adjusting the plurality of retractor blades from
`a first configuration comprising the plurality of
`retractor blades in a first position to a second
`configuration comprising the plurality of retractor
`blades in a second position in which the plurality
`of retractor blades are spaced further apart from
`one another to form the operative corridor along
`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`DR. ALLEYNE NOTES
`circumferentially for any thresholds.” [Id. at ALLEYNE000013-14]
`Regarding L2-L3: “The first dilator was placed and thresholds were tested, noted be adequate,
`K-wire was then introduced into the L2-3 disk space followed by the 2nd dilator which was
`checked circumferentially followed by the Squadron retractor blades being placed with the
`retractor uneventfully at L2-3 and opened after it was secured to the bed mount.” [Id.].
`“The patient tolerated the procedure well. At no time were there any alterations in
`somatosensory and motor evoked potentials.” [Id.]
`
`“and the retractor blades were then placed over the 2nd dilator.” [Id.]
`“the Squadron retractor was then opened” [Id.]
`“Squadron retractor was then locked to the bed mount.” [ALLEYNE000013 –
`ALLEYNE000017 at ALLEYNE000014]
`Regarding L2-L3: “The first dilator was placed and thresholds were tested, noted be adequate,
`K-wire was then introduced into the L2-3 disk space followed by the 2nd dilator which was
`checked circumferentially followed by the Squadron retractor blades being placed with the
`retractor uneventfully at L2-3 and opened after it was secured to the bed mount.” [Id.].
`
`“The Squadron retractor was opened and locked into position. This was followed by the
`placement of the shim, under AP fluoro at L4-5 followed by annulotomy that was made after
`the K-wire and the dilators were removed and the floor of the disk space was then tested
`circumferentially for any thresholds.” [Id.]
`“Squadron retractor was then opened.” [Id.]
`See Youssef Opening Report re function of Squadron retractor.
`
`8
`
`EXHIBIT 23
`Page 534
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32584 Page 11 of
`15
`
`’227 PATENT CLAIM
`the lateral, trans-psoas path, the operative corridor
`negotiating past the nerves of the psoas muscle
`without damaging the nerves and being
`dimensioned to pass an implant therethrough along
`the lateral, trans-psoas path toward the target
`intervertebral disc of the lumbar spine.
`
`[2A] The method of claim 1, wherein moving the
`plurality of retractor blades comprises moving a
`posterior retractor blade.
`
`[6A] The method of claim 2, wherein moving the
`plurality of retractor blades further comprises
`moving a caudal retractor blade and a cephalad
`retractor blade.
`
`[13A] The method of claim 1, wherein electrically
`stimulating the nerves comprises electrically
`stimulating the nerves using a respective
`stimulation electrode along a distal region of each
`of the first dilator and the second dilator.
`
`[15A] The method of claim 1, wherein moving the
`plurality of retractor blades comprises moving the
`plurality of retractor blades over at least one of the
`plurality of dilators.
`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`DR. ALLEYNE NOTES
`
`“The Squadron retractor was then opened.” [Id.]
`See Youssef Opening Report re function of Squadron retractor.
`
`“The Squadron retractor was then opened.” [Id.]
`See Youssef Opening Report re function of Squadron retractor.
`
`“Somatosensory motor evoked potentials being performed by Ms. Christina Brady.” [Id. at
`ALLEYNE000013]
`“The 1st dilator was placed and the thresholds were then checked and noted to be stable
`circumferentially,…” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator which was
`tested.” [Id.]
`See Youssef Opening Report re function of Alphatec dilators.
`
`“the retractor blades were then placed over the 2nd dilator.” [Id.]
`
`9
`
`EXHIBIT 23
`Page 535
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32585 Page 12 of
`15
`
`’227 PATENT CLAIM
`
`DR. ALLEYNE NOTES
`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`Not Asserted – Asserted Claims Depend From
`Claim 16
`[16A] A method for forming an operating corridor
`to a lumbar spine of a patient, the method
`comprising:
`
`Not Asserted – Asserted Claims Depend From
`Claim 16
`[16B] inserting a plurality of dilators into the
`patient at an insertion position on one of two
`anatomically lateral aspects of the patient, the
`plurality of dilators comprising a first dilator
`having a first diameter and a second dilator having
`a second diameter, the first diameter being smaller
`than the second diameter;
`[16C] advancing the plurality of dilators along a
`lateral, trans-psoas path from the insertion position
`on the one of two anatomically lateral aspects of
`the patient to a lateral aspect of a target
`intervertebral disc of the lumbar spine, the
`trajectory of the lateral, trans-psoas path exiting
`the patient at the other of the two anatomically
`lateral aspects of the patient, to create a tissue
`
`“Preoperative Diagnosis: L2-3, L3-4, L4-5, L5-S1 lumbar spinal stenosis with instability and
`scoliosis.” [ALLEYNE000013 – ALLEYNE000017 at ALLEYNE000013]
`“Postoperative Diagnosis: L2-3, L3-4, L4-5, L5-S1 lumbar spinal stenosis with instability and
`scoliosis.” [Id.]
`“Procedure Performed: Part 1: XLIF L2-3, L3-4, L4-5.” [Id.]
`“the anterior longitudinal ligament, posterior longitudinal ligament, the 30 yard line and the
`trajectory path were then marked at L4-5, L3-4, and L2-3. Incision was carried down through
`the skin down to subcutaneous tissue. The fascia was then entered at L4-5 by using the Metz,
`blunt dissection down to the psoas. The surgeon’s hand was then used to sweep and palpate the
`iliac crest, the TP as well as the disc space.” [Id.]
`
`“The patient was then meticulously placed onto the operating table in a lateral decubitus
`position with the right side up.” [Id.]
`“trajectory path [was] then marked at L4-5, L3-4, and L2-3… Incision was carried down
`through the skin down to subcutaneous tissue. The fascia was then entered at L4-5 by using the
`Metz, blunt dissection down to the psoas.” [Id.]
`“The 1st dilator was placed and the thresholds were then checked and noted to be stable
`circumferentially,…” [Id.]
`“Somatosensory motor evoked potentials being performed by Ms. Christina Brady.” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator which was
`tested.” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator (“and the 2nd
`dilator was circumferentially tested” [Id. at ALLEYNE000014]) which was tested and the
`retractor blades were then placed over the 2nd dilator. The Squadron retractor was then opened
`and locked into position and secured with the bed mount. This was followed by the placement
`of the shim, under AP fluoro at L4-5 followed by an annulotomy that was made after the K-
`wire and the dilators were removed and the floor of the disk space was then tested
`circumferentially for any thresholds.” [Id. at ALLEYNE000013-14]
`Regarding L2-L3: “The first dilator was placed and thresholds were tested, noted be adequate,
`10
`
`EXHIBIT 23
`Page 536
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32586 Page 13 of
`15
`
`’227 PATENT CLAIM
`distraction corridor to the target intervertebral disc
`along the lateral, trans-psoas path, the lateral,
`trans-psoas path extending through a region of a
`psoas muscle containing nerves and negotiating
`past the nerves;
`[16C] electrically stimulating, using a stimulation
`electrode along a distal region of the first dilator or
`the second dilator, the nerves of the psoas muscle
`for monitoring a nerve response and advancing the
`first dilator or the second dilator, based on the
`monitoring, along the lateral, trans-psoas path to
`avoid impairment of the nerves of the psoas
`muscle; and
`
`Not Asserted – Asserted Claims Depend From
`Claim 16
`[16D] moving a plurality of retractor blades over at
`least one of the plurality of dilators along the
`lateral, trans-psoas path to form an operative
`corridor along the lateral, trans-psoas path, the
`operative corridor being dimensioned to pass an
`implant therethrough along the lateral, trans-psoas
`path toward the target intervertebral disc of the
`lumbar spine.
`
`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`DR. ALLEYNE NOTES
`K-wire was then introduced into the L2-3 disk space followed by the 2nd dilator which was
`checked circumferentially followed by the Squadron retractor blades being placed with the
`retractor uneventfully at L2-3 and opened after it was secured to the bed mount.” [Id.].
`“The patient tolerated the procedure well. At no time were there any alterations in
`somatosensory and motor evoked potentials.” [Id.]
`
`“and the retractor blades were then placed over the 2nd dilator.” [Id.]
`“the Squadron retractor was then opened” [Id.]
`“Squadron retractor was then locked to the bed mount.” [ALLEYNE000013 –
`ALLEYNE000017 at ALLEYNE000014]
`Regarding L2-L3: “The first dilator was placed and thresholds were tested, noted be adequate,
`K-wire was then introduced into the L2-3 disk space followed by the 2nd dilator which was
`checked circumferentially followed by the Squadron retractor blades being placed with the
`retractor uneventfully at L2-3 and opened after it was secured to the bed mount.” [Id.].
`“15 blade was used to make a rectangular incision in the annulus on the right side followed by
`pituitary rongeur to remove disc material and annular debris. The trial was then used. We used
`an 8 x 18 x 55 trial filled with DBM putty and BMP prior to place cage (implant).” [Id.]
`“… the implant was then placed from Alphatec using the impacted with the impactor mallet
`noted to be in good position and our attention was then taken to L2-3.” [Id.].
`“… we used an 8 x 18 x 50 filled with BMP and DBM putty. Impacted with the impactor
`
`11
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`EXHIBIT 23
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`
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`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32587 Page 14 of
`15
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`’227 PATENT CLAIM
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`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`DR. ALLEYNE NOTES
`mallet. Prior to doing this, the disc space at L2-3 was scraped, rasped, and further disc debris
`was removed followed by disc space irrigation and suctioning of that disk space. With the
`cage now in place L2-3 intraoperative AP and lateral fluoro confirmed the position and
`orientation at all 3 levels.” [Id.].
`
`[17A] The method of claim 16, wherein moving
`the plurality of retractor blades comprises moving
`a posterior retractor blade.
`
`[22A] The method of claim 17, wherein moving
`the plurality of retractor blades further comprises
`moving a caudal retractor blade and a cephalad
`retractor blade.
`
`[28A] The method of claim 16, wherein
`electrically stimulating the nerves comprises
`electrically stimulating the nerves using a
`respective stimulation electrode along a distal
`region of each of the first dilator and the second
`dilator.
`
`“The Squadron retractor was then opened.” [Id.]
`See Youssef Opening Report re function of Squadron retractor.
`
`“The Squadron retractor was then opened.” [Id.]
`See Youssef Opening Report re function of Squadron retractor.
`
`“Somatosensory motor evoked potentials being performed by Ms. Christina Brady.” [Id. at
`ALLEYNE000013]
`“The 1st dilator was placed and the thresholds were then checked and noted to be stable
`circumferentially,…” [Id.]
`“K-wire was then placed into the L4-5 30-yard line, followed by the 2nd dilator which was
`tested.” [Id.]
`See Youssef Opening Report re function of Alphatec dilators.
`
`12
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`Case 3:18-cv-00347-CAB-MDD Document 350-24 Filed 11/06/21 PageID.32588 Page 15 of
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`HIGHLY CONFINDENTIAL-ATTORNEYS’ EYES ONLY
`
`DATED: January 8, 2020
`
`Jim A. Youssef, M.D.
`
`13
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`