Case 3:18-cv-00347-CAB-MDD Document 259-2 Filed 02/07/20 PageID.23893 Page 1 of
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`EXHIBIT 110
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`TO DECLARATION OF WENDY L. DEVINE
`IN SUPPORT OF NUVASIVE, INC.’S
`OPPOSITION TO DEFENDANTS’ MOTION
`TO EXCLUDE THE EXPERT TESTIMONY
`OF JIM YOUSSEF, BLAKE INGLISH, &
`STEPHEN KUNIN
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 259-2 Filed 02/07/20 PageID.23894 Page 2 of
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
`NUVASIVE, INC., a Delaware corporation,
` Plaintiff,
`v.
`
`Case No. 18-cv-00347-MDD-CAB
`
`)))))))))))))
`
`ALPHATEC HOLDINGS, INC., a Delaware
`corporation, and ALPHATEC SPINE, INC., a
`California corporation,
` Defendants.
`
`OPENING EXPERT REPORT OF JIM YOUSSEF
`
`EXHIBIT 110
`PAGE 5
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`

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`TABLE OF CONTENTS
`
`1.
`2.
`3.
`4.
`5.
`6.
`
`7.
`8.
`9.
`10.
`
`ASSERTED PATENTS AND CLAIMS ............................................................................ 1
`EDUCATION AND EXPERIENCE .................................................................................. 1
`COMPENSATION ............................................................................................................. 3
`PRIOR TESTIMONY ......................................................................................................... 4
`MATERIALS CONSIDERED ........................................................................................... 4
`LEGAL STANDARDS PROVIDED BY COUNSEL ....................................................... 4
`A.
`Claim Construction ................................................................................................. 4
`B.
`Infringement ............................................................................................................ 5
`C.
`Non-Infringing Alternatives .................................................................................... 7
`D.
`Objective Indicia of Non-Obviousness ................................................................... 7
`i.
`Nexus .......................................................................................................... 8
`ii.
`Skepticism ................................................................................................... 8
`iii.
`Industry Praise ............................................................................................ 8
`iv.
`Failure of Others ......................................................................................... 8
`v.
`Long-Felt Unmet Need ............................................................................... 8
`vi.
`Copying ....................................................................................................... 8
`vii.
`Teaching Away ........................................................................................... 9
`viii. Unexpected Results ..................................................................................... 9
`Public Interest ......................................................................................................... 9
`E.
`ALPHATEC’S KNOWLEDGE OF THE PATENTS-IN-SUIT ........................................ 9
`LEVEL OF ORDINARY SKILL IN THE ART .............................................................. 10
`SUMMARY OF MY OPINIONS ..................................................................................... 11
`BACKGROUND .............................................................................................................. 13
`
`i
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`A.
`B.
`
`11.
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`12.
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`History of Spinal Fusion Procedures Prior to XLIF ............................................. 13
`XLIF Solves the Problems Associated With Other Procedures ............................ 27
`i.
`Access Tools ............................................................................................. 29
`ii.
`Implant ...................................................................................................... 32
`iii.
`Neuromonitoring ....................................................................................... 33
`iv.
`NuVasive’s Patents ................................................................................... 35
`ALPHATEC’S PRODUCTS ............................................................................................ 35
`i.
`Retroperitoneal Access ............................................................................. 37
`ii.
`Retroperitoneal Approach ......................................................................... 38
`iii.
`Traversing the Psoas ................................................................................. 38
`iv.
`Disc Space Access .................................................................................... 40
`v.
`Disc Preparation ........................................................................................ 41
`vi.
`Implant Sizing & Insertion........................................................................ 42
`vii.
`Supplemental Fixation & Closure ............................................................. 42
`THE ’801 PATENT .......................................................................................................... 43
`A.
`Claim 1 .................................................................................................................. 44
`i.
`[1A]—A system for accessing a surgical target site, comprising: ............ 44
`ii.
`[1B]—a dilator system comprising a plurality of sequential dilators
`deliverable along a lateral, trans-psoas path to a targeted spinal site
`to create a distraction corridor .................................................................. 45
`[1C]—a handle assembly including a first pivotable arm member, a
`second pivotable arm member that pivots relative to said first arm
`member in response to manual adjustment of a component of the
`handle assembly, and a translating member adapted to move
`longitudinally relative to said first and second arm members .................. 47
`[1D]—a first retractor blade having a generally concave inner-
`facing surface and being rigidly coupled to said first pivotable arm
`member prior to introduction toward the targeted spinal site, a
`second retractor blade having a generally concave inner-facing
`surface and being rigidly coupled to said second pivotable arm
`member prior to introduction toward the targeted spinal site, and a
`third retractor blade rigidly coupled to said translating member
`prior to introduction toward the targeted spinal site ................................. 49
`
`iii.
`
`iv.
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`ii
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`vi.
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`[1E]—an intradiscal shim element that releasably mounts to the
`third retractor blade such that a maximum length of the intradiscal
`shim element extends generally parallel to a maximum length of
`the third retractor blade and a distal tip portion of the intradiscal
`shim element extends distally of the distal end of the third retractor
`blade, wherein the intradiscal shim element engages with a groove
`defined by the third retractor blade to penetrate into a spinal disc at
`the targeted spinal site when the intradiscal shim element is
`releasably mounted to the third retractor blade; and ................................. 52
`[1F]—said handle assembly being configured to simultaneously
`introduce said first, second and third retractor blades along the
`lateral, trans-psoas path toward the targeted spinal site in a closed
`position while the generally concave inner-facing surfaces of said
`first and second retractor blades engage with an outermost dilator
`of the dilator system and thereafter opened by pivoting said first
`and second pivotable arm members relative to one another to
`create an operative corridor to said surgical target site. ............................ 55
`Claim 2 .................................................................................................................. 58
`i.
`[2A]—The system of claim 1, further comprising a K-wire
`configured to be advance [sic] along the lateral, trans-psoas path to
`the targeted spinal site and engage an annulus of said spinal disc,
`the K-wire further configured to extend entirely through a dilator
`of said dilator system from the annulus of the spinal disc to a
`position beyond a proximal most end of the dilator system. .................... 58
`Claim 6 .................................................................................................................. 59
`i.
`[6A]—The system of claim 1, wherein at least one of said plurality
`of sequential dilators is equipped with at least one stimulation
`electrode. ................................................................................................... 59
`Claim 15 ................................................................................................................ 60
`i.
`[15A]—The system of claim 1, wherein each of the plurality of
`sequential dilators includes a stimulation electrode at a distal
`region. ....................................................................................................... 60
`Claim 16 ................................................................................................................ 61
`i.
`[16A]—The system of claim 15, further comprising a K-wire
`configured to be advanced to the targeted spinal site and to engage
`an annulus of said spinal disc at the targeted spinal site, wherein at
`least one of the plurality of sequential dilators are deliverable over
`the K-wire. ................................................................................................ 61
`Claim 17 ................................................................................................................ 62
`i.
`[17A]—The system of claim 1, wherein the first retractor blade
`includes a groove formed along said generally concave inner-
`facing surface of the first retractor blade. ................................................. 62
`
`B.
`
`C.
`
`D.
`
`E.
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`F.
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`H.
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`J.
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`Claim 19 ................................................................................................................ 63
`i.
`[19A]—The system of claim 1, wherein the third retractor blade
`includes a generally concave inner-facing surface and the groove
`of the third retractor blade is formed along the generally concave
`inner-facing surface. ................................................................................. 63
`Claim 20 ................................................................................................................ 65
`i.
`[20A]—The system of claim 19, wherein the intradiscal shim
`element includes at least one dovetail element to mate with the
`groove of the third retractor blade. ........................................................... 65
`Claim 21 ................................................................................................................ 66
`i.
`[21A]—The system of claim 1, wherein the second retractor blade
`includes a groove formed along said generally concave inner-
`facing surface of the second retractor blade. ............................................ 66
`Claim 23 ................................................................................................................ 67
`i.
`[23A]—The system of claim 1, wherein said handle is configured
`to simultaneously move said first arm member and said second arm
`member. .................................................................................................... 67
`Claim 26 ................................................................................................................ 69
`i.
`[26A]—The system of claim 1, further comprising a shim insertion
`tool that releasably attaches to the intradiscal shim element during
`introduction of the intradiscal shim element toward the targeted
`spinal site. ................................................................................................. 69
`Claim 28 ................................................................................................................ 70
`i.
`[28A]—The system of claim 1, wherein the handle assembly
`further includes a locking mechanism to selectively lock at least
`the first arm member in a retracted position such that the first
`retractor blade is spaced apart from the second retractor blade. ............... 70
`Claim 29 ................................................................................................................ 70
`i.
`[29A]—The system of claim 1, wherein the first, second, and third
`retractor blades define an operative corridor to the targeted spinal
`site when moved to the opened position such that an implant is
`deliverable through the operative corridor to the targeted spinal
`site. ............................................................................................................ 70
`THE ’780 PATENT .......................................................................................................... 72
`A.
`Claim 21 ................................................................................................................ 73
`i.
`[21A]—A system for forming an operating corridor to a lumbar
`spine, comprising: ..................................................................................... 73
`
`M.
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`K.
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`L.
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`13.
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`iii.
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`iv.
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`v.
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`[21B(i)]—a dilator system to create a distraction corridor along a
`lateral, trans-psoas path to the lumbar spine, wherein said dilator
`system comprises at least two dilators of sequentially larger widths
`deliverable to a spinal disc along the lateral, trans-psoas path to the
`lumbar spine, a second dilator of said at least two dilators being
`slidably engageable with an exterior of a first of said at least two
`dilators, [21B(ii)]- at least one of the first and second dilators
`including a stimulation electrode to deliver electrical stimulation
`for nerve monitoring when the stimulation electrode is positioned
`along the lateral, trans-psoas path to the lumbar spine; ............................ 73
`[21C]- a three-bladed retractor assembly slidable over the dilator
`system toward the spinal disc along the lateral, trans-psoas path, ............ 76
`[21D]—the three-bladed retractor assembly including: a blade
`holder assembly and first, second, and third retractor blades that
`extend generally perpendicularly relative to arm members of the
`blade holder assembly, .............................................................................. 77
`[21E]—wherein the three-bladed retractor assembly is adjustable
`from a first position in which the first, second, and third retractor
`blades are adjacent to one another and slidable over the dilator
`system to a second position in which the second and third retractor
`blades are moved away from the first retractor blade to enlarge the
`distraction corridor and thereby form an operative corridor along
`the lateral, trans-psoas path to the lumbar spine, ...................................... 78
`[21F]—wherein the first retractor blade is linearly movable relative
`to the second and third retractor blades in response to rotation of a
`knob element on the blade holder assembly, ............................................ 80
`[21G(i)]—wherein the second refractor [sic] blade is movable
`relative to the first blade in response to pivoting movement of a
`first pivotable arm member of said arm members which is coupled
`to the second retractor blade, and [21G(ii)]—wherein the third
`retractor blade is movable relative to the first blade in response to
`pivoting movement of a second pivotable arm member of said arm
`members which is coupled to the third refractor [sic] blade; and ............. 81
`[21H(i)]—wherein when the three-bladed retractor assembly is
`adjusted to the second position to form the operative corridor along
`the lateral, trans-psoas path to the lumbar spine, the first retractor
`blade is a posterior-most retractor blade of the first, second, and
`third retractor blades and [21H(ii)]—the operative corridor is
`dimensioned so as to pass an implant through the operative
`corridor and into the lumbar spine. ........................................................... 82
`Claim 22 ................................................................................................................ 83
`i.
`[22A]—The system of claim 21, wherein when the three-bladed
`retractor assembly is adjusted to the second position to form the
`operative corridor, the first retractor blade is the posterior-most
`retractor blade, the second blade is a cephalad-most retractor blade,
`and the third blade is a caudal-most refractor [sic] blade. ........................ 83
`
`viii.
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`vi.
`
`vii.
`
`B.
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`v
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`C.
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`E.
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`F.
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`D.
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`Claim 24 ................................................................................................................ 84
`i.
`[24A]—The system of claim 21, wherein said arm members of the
`blade holder assembly further comprise a translating arm member
`coupled to the first retractor blade, wherein the rotation of the knob
`element of the blade holder assembly causes the translating arm
`member to linearly adjust a position of the first retractor blade
`relative to the second and third retractor blades. ...................................... 84
`Claim 25 ................................................................................................................ 85
`i.
`[25A]—The system of clam 21, wherein the three-bladed retractor
`assembly includes an intradiscal shim element having a proximal
`portion removably engageable with the first retractor blade so that
`a distal portion of the shim element extends from a distal end of
`the first retractor blade and is configured to penetrate into the
`spinal disc, wherein the proximal portion of the shim element is
`slidably engageable with grooves defined along the first retractor
`blade. ......................................................................................................... 85
`Claim 26 ................................................................................................................ 87
`i.
`[26A]- The system of claim 21, wherein the second and third
`retractor blades are configured to simultaneously move in response
`to movement of the first and second pivotable arm members. ................. 87
`Claim 27 ................................................................................................................ 88
`i.
`[27]—The system of claim 21, further comprising an elongate
`member deliverable to a spinal disc along a lateral, transpsoas path
`to the lumbar spine such that a distal tip region of the elongate
`member is configured to penetrate into an annulus of the spinal
`disc, said first dilator being configured to slidably engage an
`exterior of the elongate member. .............................................................. 88
`Claim 28 ................................................................................................................ 89
`i.
`[28A]- The system of claim 21, wherein when the three-bladed
`retractor assembly is in the first position, the first, second, and
`third retractor blades are in generally abutting relation with one
`another....................................................................................................... 89
`THE ’832 PATENT .......................................................................................................... 90
`A.
`Claim 1 .................................................................................................................. 91
`i.
`[1A]- A system for forming an operating corridor to a lumbar
`spine, comprising: ..................................................................................... 91
`[1B]- a distraction assembly to create a tissue distraction corridor
`in a lateral, trans-psoas path to a lumbar spine, wherein said
`distraction assembly includes an elongate inner element and a
`plurality of dilators, the plurality of dilators being configured to
`sequentially advance along the lateral, trans-psoas path to the
`
`G.
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`14.
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`ii.
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`iii.
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`iv.
`v.
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`lumbar spine, the elongate inner element being positionable in a
`lumen of an initial dilator of the plurality of dilators, wherein at
`least one instrument from the group consisting of said elongate
`inner element and said dilators includes a stimulation electrode that
`outputs electrical stimulation for nerve monitoring when the at
`least one instrument is positioned in the psoas muscle; ............................ 92
`[1C]- a three-bladed retractor tool slidable over an exterior of an
`outermost sequential dilator of the dilator system toward the
`targeted spinal disc along the lateral, trans-psoas path, the three-
`bladed retractor assembly including: ........................................................ 95
`[1D]- a blade-holder assembly, and .......................................................... 95
`[1E]- a posterior-most retractor blade, a cephalad-most retractor
`blade, and a caudal-most retractor blade that extend from the
`blade-holder assembly, wherein the posterior-most, cephalad-most,
`and caudal-most retractor blades are slidably advanced over the
`exterior of the outermost sequential dilator while in a first position,
`wherein the blade-holder assembly is adjustable to move the
`posterior-most, cephalad-most, and caudal-most retractor blades to
`a second position in which the cephalad-most and caudal-most
`retractor blades are spaced apart from the posterior-most retractor
`blade to define an operative corridor, ....................................................... 96
`[1F]- wherein three-bladed retractor tool is configured to define the
`operative corridor along the lateral, trans-psoas path to the lumbar
`spine in which a space extending to the targeted spinal disc
`between the posterior-most, cephalad-most, and caudal-most
`refractor blades is dimensioned so as to pass an implant through
`the operative corridor along the lateral, trans-psoas path to the
`lumbar spine. ............................................................................................. 97
`Claim 2 .................................................................................................................. 98
`i.
`[2A]- The system of claim 1, wherein the blade-holder assembly is
`adjustable to move the cephalad-most and caudal-most retractor
`blades away from the posterior-most retractor blade while the
`posterior-most retractor blade remains in a generally stationary
`position relative to the targeted spinal disc. .............................................. 98
`Claim 3 .................................................................................................................. 99
`i.
`[3A]- The system of claim 1, wherein the elongate inner member is
`advanced along the lateral, trans-psoas path to the targeted spinal
`disc such that a distal tip portion of the elongate inner member
`penetrates into an annulus of the targeted spinal disc. .............................. 99
`Claim 4 ................................................................................................................ 100
`i.
`[4A]- The system of claim 1, wherein the elongate inner member
`comprises a K-wire. ................................................................................ 100
`Claim 6 ................................................................................................................ 101
`
`vi.
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`B.
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`C.
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`D.
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`E.
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`i.
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`F.
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`G.
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`H.
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`I.
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`[6A]- The system of claim 1, wherein when the three-bladed
`retractor tool defines the operative corridor, the posterior-most,
`cephalad-most, and caudal-most retractor blades are spaced apart
`and maintained generally parallel to one another. .................................. 101
`Claim 7 ................................................................................................................ 103
`i.
`[7A]- The system of claim 1, wherein when the three-bladed
`retractor tool is in the first position, each of the posterior-most,
`cephalad-most, and caudal-most retractor blades at least partially
`abuts with edges of the other two of the posterior-most, cephalad-
`most, and caudal-most refractor blades. ................................................. 103
`Claim 8 ................................................................................................................ 104
`i.
`[8A]- The system of claim 1, wherein further comprising a light
`emitting device to direct light through the operative corridor
`toward the targeted spinal disc. ............................................................... 104
`Claim 9 ................................................................................................................ 105
`i.
`[9A]- The system of claim 1, further comprising a fourth retractor
`blade that couples with the blade-holder assembly only after the
`blade-holder assembly moves the posterior-most, cephalad-most,
`and caudal-most retractor blades to the second position. ....................... 105
`Claim 10 .............................................................................................................. 106
`i.
`[10A]- The system of claim 1, further comprising a fixation
`element to releasably engage with one of said retractor blades so
`that at least a portion of the fixation element extends distally into
`the lumbar spine, wherein the fixation element is configured to
`releasably engage with the posterior-most retractor blade after the
`posterior-most retractor blade is advanced along the lateral, trans-
`psoas path to the lumbar spine. ............................................................... 106
`J. Claim 12 ...................................................................................................................... 107
`ii.
`[12A]- A method for accessing a spinal disc of a lumbar spine of a
`patient;..................................................................................................... 107
`[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; .............................................................................. 108
`[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; ......................... 110
`
`iii.
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`iv.
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`v.
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`vi.
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`vii.
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`[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; ............................................................................ 112
`[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 ........................................................................................................... 113
`[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. ...................... 114
`K. Claim 13 ..................................................................................................................... 116
`i.
`[13A]- The method of claim 12, further comprising adjusting said
`blade holder assembly so as to move said cephalad-most and
`caudal-most retractor blades away from said posterior-most
`retractor blade to create said operative corridor along said lateral,
`trans-psoas path to said targeted spinal disc, wherein said operative
`corridor is dimensioned so as to pass a spinal implant through said
`operative corridor along said lateral, trans-psoas path to said
`targeted spinal disc. ................................................................................. 116
`Claim 14 .............................................................................................................. 118
`i.
`[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. ........ 118
`Claim 16 .............................................................................................................. 118
`i.
`[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.............................................................................................. 118
`Claim 17 .............................................................................................................. 120
`i.
`[17A]- The method of claim 12, further comprising advancing said
`elongate inner member along said lateral, trans-psoas path and into
`the disc space. ......................................................................................... 120
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`L.
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`M.
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`O.
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`15.
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`ii.
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`iii.
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`Claim 19 .............................................................................................................. 121
`i.
`[19A]- The method of claim 12, wherein each of said plurality of
`sequentially larger diameter dilators comprises a distal end on
`which a respective stimulation electrode is situated, said distal end
`being angled relative to a longitudinal axis of said dilator such that
`said stimulation electrode is angled relative to said longitudinal
`axis. ......................................................................................................... 121
`THE ’227 PATENT ........................................................................................................ 123
`A.
`Claim 1 ................................................................................................................ 124
`i.
`[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: ......................... 124
`[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; .................................. 125
`[1C]- advancing the pluralit