`
`EXHIBIT 57
`
`TO DECLARATION OF WENDY L. DEVINE
`IN SUPPORT OF NUVASIVE, INC.’S
`OPPOSITION TO DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY
`ADJUDICATION
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 261-5 Filed 02/07/20 PageID.24993 Page 2 of 44
`
`UNITED STATES DISTRICT COURT
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
`SOUTHERN DISTRICT OF CALIFORNIA — SAN DIEGO DIVISION
`NUVASIVE, INC., a Delaware corporation,
`NUVASIVE, INC., a Delaware corporation,
` Plaintiff,
`Plaintiff,
`v.
`v.
`
`ALPHATEC HOLDINGS, INC., a Delaware
`ALPHATEC HOLDINGS, INC., a Delaware
`corporation, and ALPHATEC SPINE, INC., a
`corporation, and ALPHATEC SPINE, INC., a
`California corporation,
`California corporation,
` Defendants.
`Defendants.
`
`
`
`)))))))))))))
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`1
`OPENING EXPERT REPORT OF JIM YOUSSEF
`OPENING EXPERT REPORT OF JIM YOUSSEF
`
`Case No. 18-cv-00347-MDD-CAB
`Case No. 18-cv-00347-MDD-CAB
`
`EXHIBIT 57
`PAGE 15
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 261-5 Filed 02/07/20 PageID.24994 Page 3 of 44
`
`TABLE OF CONTENTS
`TABLE OF CONTENTS
`
`1.
`1.
`2.
`2.
`3.
`3.
`4.
`4.
`5.
`5.
`6.
`6.
`
`7.
`7.
`8.
`8.
`9.
`9.
`10.
`10.
`
`ASSERTED PATENTS AND CLAIMS ............................................................................ 1
`1
`ASSERTED PATENTS AND CLAIMS
`EDUCATION AND EXPERIENCE .................................................................................. 1
`1
`EDUCATION AND EXPERIENCE
`COMPENSATION ............................................................................................................. 3
`3
`COMPENSATION
`PRIOR TESTIMONY ......................................................................................................... 4
`4
`PRIOR TESTIMONY
`MATERIALS CONSIDERED ........................................................................................... 4
`4
`MATERIALS CONSIDERED
`LEGAL STANDARDS PROVIDED BY COUNSEL ....................................................... 4
`4
`LEGAL STANDARDS PROVIDED BY COUNSEL
`A.
`Claim Construction ................................................................................................. 4
`A.
`4
`Claim Construction
`B.
`Infringement ............................................................................................................ 5
`B.
`5
`Infringement
`C.
`Non-Infringing Alternatives .................................................................................... 7
`C.
`Non-Infringing Alternatives
`7
`D.
`Objective Indicia of Non-Obviousness ................................................................... 7
`D.
`7
`Objective Indicia of Non-Obviousness
`i.
`Nexus .......................................................................................................... 8
`i.
`8
`Nexus
`ii.
`Skepticism ................................................................................................... 8
`ii.
`Skepticism
`8
`iii.
`Industry Praise ............................................................................................ 8
`iii.
`Industry Praise
`8
`iv.
`Failure of Others ......................................................................................... 8
`iv.
`8
`Failure of Others
`v.
`Long-Felt Unmet Need ............................................................................... 8
`v.
`8
`Long-Felt Unmet Need
`vi.
`Copying ....................................................................................................... 8
`Copying
`vi.
`8
`vii.
`Teaching Away ........................................................................................... 9
`vii.
`Teaching Away
`9
`viii. Unexpected Results ..................................................................................... 9
`viii. Unexpected Results
`9
`Public Interest ......................................................................................................... 9
`E.
`E.
`Public Interest
`9
`ALPHATEC’S KNOWLEDGE OF THE PATENTS-IN-SUIT ........................................ 9
`9
`ALPHATEC'S KNOWLEDGE OF THE PATENTS-IN-SUIT
`LEVEL OF ORDINARY SKILL IN THE ART .............................................................. 10
`LEVEL OF ORDINARY SKILL IN THE ART
`10
`SUMMARY OF MY OPINIONS ..................................................................................... 11
`11
`SUMMARY OF MY OPINIONS
`BACKGROUND .............................................................................................................. 13
`13
`BACKGROUND
`
`i i
`
`EXHIBIT 57
`PAGE 16
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`
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`Case 3:18-cv-00347-CAB-MDD Document 261-5 Filed 02/07/20 PageID.24995 Page 4 of 44
`
`A.
`A.
`B.
`B.
`
`History of Spinal Fusion Procedures Prior to XLIF ............................................. 13
`History of Spinal Fusion Procedures Prior to XLIF
`13
`XLIF Solves the Problems Associated With Other Procedures ............................ 27
`27
`XLIF Solves the Problems Associated With Other Procedures
`i.
`Access Tools ............................................................................................. 29
`29
`i.
`Access Tools
`ii.
`Implant ...................................................................................................... 32
`ii.
`32
`Implant
`iii.
`Neuromonitoring ....................................................................................... 33
`iii.
`Neuromonitoring
`33
`iv.
`NuVasive’s Patents ................................................................................... 35
`iv.
`35
`NuVasive's Patents
`11.
`ALPHATEC’S PRODUCTS ............................................................................................ 35
`11. ALPHATEC'S PRODUCTS
`35
`i.
`Retroperitoneal Access ............................................................................. 37
`37
`i.
`Retroperitoneal Access
`ii.
`Retroperitoneal Approach ......................................................................... 38
`ii.
`Retroperitoneal Approach
`38
`iii.
`Traversing the Psoas ................................................................................. 38
`iii.
`Traversing the Psoas
`38
`iv.
`Disc Space Access .................................................................................... 40
`iv.
`40
`Disc Space Access
`v.
`Disc Preparation ........................................................................................ 41
`Disc Preparation
`41
`v.
`vi.
`Implant Sizing & Insertion........................................................................ 42
`vi.
`Implant Sizing & Insertion
`42
`vii.
`Supplemental Fixation & Closure ............................................................. 42
`vii.
`42
`Supplemental Fixation & Closure
`THE ’801 PATENT .......................................................................................................... 43
`THE '801 PATENT
`43
`A.
`Claim 1 .................................................................................................................. 44
`A.
`Claim 1
`44
`i.
`[1A]—A system for accessing a surgical target site, comprising: ............ 44
`44
`i.
`[lAl—A system for accessing a surgical target site, comprising:
`ii.
`[1B]—a dilator system comprising a plurality of sequential dilators
`[1I3]—a dilator system comprising a plurality of sequential dilators
`ii.
`deliverable along a lateral, trans-psoas path to a targeted spinal site
`deliverable along a lateral, trans-psoas path to a targeted spinal site
`to create a distraction corridor .................................................................. 45
`45
`to create a distraction corridor
`[1C]—a handle assembly including a first pivotable arm member, a
`[1q—a handle assembly including a first pivotable arm member, a
`second pivotable arm member that pivots relative to said first arm
`second pivotable arm member that pivots relative to said first arm
`member in response to manual adjustment of a component of the
`member in response to manual adjustment of a component of the
`handle assembly, and a translating member adapted to move
`handle assembly, and a translating member adapted to move
`longitudinally relative to said first and second arm members .................. 47
`47
`longitudinally relative to said first and second arm members
`[1D]—a first retractor blade having a generally concave inner-
`[1D]—a first retractor blade having a generally concave inner-
`facing surface and being rigidly coupled to said first pivotable arm
`facing surface and being rigidly coupled to said first pivotable arm
`member prior to introduction toward the targeted spinal site, a
`member prior to introduction toward the targeted spinal site, a
`second retractor blade having a generally concave inner-facing
`second retractor blade having a generally concave inner-facing
`surface and being rigidly coupled to said second pivotable arm
`surface and being rigidly coupled to said second pivotable arm
`member prior to introduction toward the targeted spinal site, and a
`member prior to introduction toward the targeted spinal site, and a
`third retractor blade rigidly coupled to said translating member
`third retractor blade rigidly coupled to said translating member
`prior to introduction toward the targeted spinal site ................................. 49
`49
`prior to introduction toward the targeted spinal site
`
`12.
`12.
`
`iii.
`iii.
`
`iv.
`iv.
`
`ii ii
`
`EXHIBIT 57
`PAGE 17
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`
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`Case 3:18-cv-00347-CAB-MDD Document 261-5 Filed 02/07/20 PageID.24996 Page 5 of 44
`
`v.
`v.
`
`vi.
`vi.
`
`[1E]—an intradiscal shim element that releasably mounts to the
`[1E]—an intradiscal shim element that releasably mounts to the
`third retractor blade such that a maximum length of the intradiscal
`third retractor blade such that a maximum length of the intradiscal
`shim element extends generally parallel to a maximum length of
`shim element extends generally parallel to a maximum length of
`the third retractor blade and a distal tip portion of the intradiscal
`the third retractor blade and a distal tip portion of the intradiscal
`shim element extends distally of the distal end of the third retractor
`shim element extends distally of the distal end of the third retractor
`blade, wherein the intradiscal shim element engages with a groove
`blade, wherein the intradiscal shim element engages with a groove
`defined by the third retractor blade to penetrate into a spinal disc at
`defined by the third retractor blade to penetrate into a spinal disc at
`the targeted spinal site when the intradiscal shim element is
`the targeted spinal site when the intradiscal shim element is
`releasably mounted to the third retractor blade; and ................................. 52
`releasably mounted to the third retractor blade; and
`52
`[1F]—said handle assembly being configured to simultaneously
`[1F]—said handle assembly being configured to simultaneously
`introduce said first, second and third retractor blades along the
`introduce said first, second and third retractor blades along the
`lateral, trans-psoas path toward the targeted spinal site in a closed
`lateral, trans-psoas path toward the targeted spinal site in a closed
`position while the generally concave inner-facing surfaces of said
`position while the generally concave inner-facing surfaces of said
`first and second retractor blades engage with an outermost dilator
`first and second retractor blades engage with an outermost dilator
`of the dilator system and thereafter opened by pivoting said first
`of the dilator system and thereafter opened by pivoting said first
`and second pivotable arm members relative to one another to
`and second pivotable arm members relative to one another to
`create an operative corridor to said surgical target site. ............................ 55
`create an operative corridor to said surgical target site
`55
`Claim 2 .................................................................................................................. 58
`Claim 2
`58
`i.
`[2A]—The system of claim 1, further comprising a K-wire
`i.
`[2A]—The system of claim 1, further comprising a K-wire
`configured to be advance [sic] along the lateral, trans-psoas path to
`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 targeted spinal site and engage an annulus of said spinal disc,
`the K-wire further configured to extend entirely through a dilator
`the K-wire further configured to extend entirely through a dilator
`of said dilator system from the annulus of the spinal disc to a
`of said dilator system from the annulus of the spinal disc to a
`position beyond a proximal most end of the dilator system. .................... 58
`position beyond a proximal most end of the dilator system.
`58
`Claim 6 .................................................................................................................. 59
`Claim 6
`59
`i.
`[6A]—The system of claim 1, wherein at least one of said plurality
`[6A]—The system of claim 1, wherein at least one of said plurality
`i.
`of sequential dilators is equipped with at least one stimulation
`of sequential dilators is equipped with at least one stimulation
`electrode. ................................................................................................... 59
`59
`electrode.
`Claim 15 ................................................................................................................ 60
`Claim 15
`60
`i.
`[15A]—The system of claim 1, wherein each of the plurality of
`[15A]—The system of claim 1, wherein each of the plurality of
`i.
`sequential dilators includes a stimulation electrode at a distal
`sequential dilators includes a stimulation electrode at a distal
`region. ....................................................................................................... 60
`region.
`60
`Claim 16 ................................................................................................................ 61
`Claim 16
`61
`i.
`[16A]—The system of claim 15, further comprising a K-wire
`[16A]—The system of claim 15, further comprising a K-wire
`i.
`configured to be advanced to the targeted spinal site and to engage
`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
`an annulus of said spinal disc at the targeted spinal site, wherein at
`least one of the plurality of sequential dilators are deliverable over
`least one of the plurality of sequential dilators are deliverable over
`the K-wire. ................................................................................................ 61
`the K-wire.
`61
`Claim 17 ................................................................................................................ 62
`Claim 17
`62
`i.
`[17A]—The system of claim 1, wherein the first retractor blade
`i.
`[17A]—The system of claim 1, wherein the first retractor blade
`includes a groove formed along said generally concave inner-
`includes a groove formed along said generally concave inner-
`facing surface of the first retractor blade. ................................................. 62
`62
`facing surface of the first retractor blade.
`
`B.
`B.
`
`C.
`C.
`
`D.
`D.
`
`E.
`E.
`
`F.
`F.
`
`iii
`iii
`
`EXHIBIT 57
`PAGE 18
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 261-5 Filed 02/07/20 PageID.24997 Page 6 of 44
`
`H.
`H.
`
`I.
`I.
`
`J.
`J.
`
`G.
`G.
`
`Claim 19 ................................................................................................................ 63
`Claim 19
`63
`i.
`[19A]—The system of claim 1, wherein the third retractor blade
`i.
`[19A]—The system of claim 1, wherein the third retractor blade
`includes a generally concave inner-facing surface and the groove
`includes a generally concave inner-facing surface and the groove
`of the third retractor blade is formed along the generally concave
`of the third retractor blade is formed along the generally concave
`inner-facing surface. ................................................................................. 63
`inner-facing surface.
`63
`Claim 20 ................................................................................................................ 65
`Claim 20
`65
`i.
`[20A]—The system of claim 19, wherein the intradiscal shim
`[20A]—The system of claim 19, wherein the intradiscal shim
`i.
`element includes at least one dovetail element to mate with the
`element includes at least one dovetail element to mate with the
`groove of the third retractor blade. ........................................................... 65
`groove of the third retractor blade.
`65
`Claim 21 ................................................................................................................ 66
`Claim 21
`66
`i.
`[21A]—The system of claim 1, wherein the second retractor blade
`i.
`[21Al—The system of claim 1, wherein the second retractor blade
`includes a groove formed along said generally concave inner-
`includes a groove formed along said generally concave inner-
`facing surface of the second retractor blade. ............................................ 66
`facing surface of the second retractor blade.
`66
`Claim 23 ................................................................................................................ 67
`Claim 23
`67
`i.
`[23A]—The system of claim 1, wherein said handle is configured
`i.
`[23A]—The system of claim 1, wherein said handle is configured
`to simultaneously move said first arm member and said second arm
`to simultaneously move said first arm member and said second arm
`member. .................................................................................................... 67
`member.
`67
`Claim 26 ................................................................................................................ 69
`Claim 26
`69
`i.
`[26A]—The system of claim 1, further comprising a shim insertion
`[26A]—The system of claim 1, further comprising a shim insertion
`i.
`tool that releasably attaches to the intradiscal shim element during
`tool that releasably attaches to the intradiscal shim element during
`introduction of the intradiscal shim element toward the targeted
`introduction of the intradiscal shim element toward the targeted
`spinal site. ................................................................................................. 69
`spinal site.
`69
`Claim 28 ................................................................................................................ 70
`Claim 28
`70
`i.
`[28A]—The system of claim 1, wherein the handle assembly
`i.
`[28A]—The system of claim 1, wherein the handle assembly
`further includes a locking mechanism to selectively lock at least
`further includes a locking mechanism to selectively lock at least
`the first arm member in a retracted position such that the first
`the first arm member in a retracted position such that the first
`retractor blade is spaced apart from the second retractor blade. ............... 70
`retractor blade is spaced apart from the second retractor blade
`70
`Claim 29 ................................................................................................................ 70
`Claim 29
`70
`i.
`[29A]—The system of claim 1, wherein the first, second, and third
`i.
`[29A]—The system of claim 1, wherein the first, second, and third
`retractor blades define an operative corridor to the targeted spinal
`retractor blades define an operative corridor to the targeted spinal
`site when moved to the opened position such that an implant is
`site when moved to the opened position such that an implant is
`deliverable through the operative corridor to the targeted spinal
`deliverable through the operative corridor to the targeted spinal
`site. ............................................................................................................ 70
`site.
`70
`THE ’780 PATENT .......................................................................................................... 72
`THE '780 PATENT
`72
`A.
`Claim 21 ................................................................................................................ 73
`A.
`Claim 21
`73
`i.
`[21A]—A system for forming an operating corridor to a lumbar
`[21A]—A system for forming an operating corridor to a lumbar
`i.
`spine, comprising: ..................................................................................... 73
`spine, comprising:
`73
`
`K.
`K.
`
`L.
`L.
`
`M.
`M.
`
`13.
`13.
`
`iv iv
`
`EXHIBIT 57
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`
`ii.
`ii.
`
`iii.
`iii.
`
`iv.
`iv.
`
`v.
`v.
`
`[21B(i)]—a dilator system to create a distraction corridor along a
`[21B(i)]—a dilator system to create a distraction corridor along a
`lateral, trans-psoas path to the lumbar spine, wherein said dilator
`lateral, trans-psoas path to the lumbar spine, wherein said dilator
`system comprises at least two dilators of sequentially larger widths
`system comprises at least two dilators of sequentially larger widths
`deliverable to a spinal disc along the lateral, trans-psoas path to the
`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
`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
`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
`dilators, [21B(ii)]- at least one of the first and second dilators
`including a stimulation electrode to deliver electrical stimulation
`including a stimulation electrode to deliver electrical stimulation
`for nerve monitoring when the stimulation electrode is positioned
`for nerve monitoring when the stimulation electrode is positioned
`along the lateral, trans-psoas path to the lumbar spine; ............................ 73
`73
`along the lateral, trans-psoas path to the lumbar spine;
`[21C]- a three-bladed retractor assembly slidable over the dilator
`[21C]- a three-bladed retractor assembly slidable over the dilator
`system toward the spinal disc along the lateral, trans-psoas path, ............ 76
`system toward the spinal disc along the lateral, trans-psoas path,
`76
`[21D]—the three-bladed retractor assembly including: a blade
`[21D]—the three-bladed retractor assembly including: a blade
`holder assembly and first, second, and third retractor blades that
`holder assembly and first, second, and third retractor blades that
`extend generally perpendicularly relative to arm members of the
`extend generally perpendicularly relative to arm members of the
`blade holder assembly, .............................................................................. 77
`blade holder assembly,
`77
`[21E]—wherein the three-bladed retractor assembly is adjustable
`[21E]—wherein the three-bladed retractor assembly is adjustable
`from a first position in which the first, second, and third retractor
`from a first position in which the first, second, and third retractor
`blades are adjacent to one another and slidable over the dilator
`blades are adjacent to one another and slidable over the dilator
`system to a second position in which the second and third retractor
`system to a second position in which the second and third retractor
`blades are moved away from the first retractor blade to enlarge the
`blades are moved away from the first retractor blade to enlarge the
`distraction corridor and thereby form an operative corridor along
`distraction corridor and thereby form an operative corridor along
`the lateral, trans-psoas path to the lumbar spine, ...................................... 78
`the lateral, trans-psoas path to the lumbar spine,
`78
`[21F]—wherein the first retractor blade is linearly movable relative
`[21Fl—wherein the first retractor blade is linearly movable relative
`to the second and third retractor blades in response to rotation of a
`to the second and third retractor blades in response to rotation of a
`knob element on the blade holder assembly, ............................................ 80
`knob element on the blade holder assembly,
`80
`[21G(i)]—wherein the second refractor [sic] blade is movable
`[21G(i)]—wherein the second refractor [sic] blade is movable
`relative to the first blade in response to pivoting movement of a
`relative to the first blade in response to pivoting movement of a
`first pivotable arm member of said arm members which is coupled
`first pivotable arm member of said arm members which is coupled
`to the second retractor blade, and [21G(ii)]—wherein the third
`to the second retractor blade, and [21G(ii)]—wherein the third
`retractor blade is movable relative to the first blade in response to
`retractor blade is movable relative to the first blade in response to
`pivoting movement of a second pivotable arm member of said arm
`pivoting movement of a second pivotable arm member of said arm
`members which is coupled to the third refractor [sic] blade; and ............. 81
`81
`members which is coupled to the third refractor [sic] blade; and
`[21H(i)]—wherein when the three-bladed retractor assembly is
`[21H(i)]—wherein when the three-bladed retractor assembly is
`adjusted to the second position to form the operative corridor along
`adjusted to the second position to form the operative corridor along
`the lateral, trans-psoas path to the lumbar spine, the first retractor
`the lateral, trans-psoas path to the lumbar spine, the first retractor
`blade is a posterior-most retractor blade of the first, second, and
`blade is a posterior-most retractor blade of the first, second, and
`third retractor blades and [21H(ii)]—the operative corridor is
`third retractor blades and [21H(ii)]—the operative corridor is
`dimensioned so as to pass an implant through the operative
`dimensioned so as to pass an implant through the operative
`corridor and into the lumbar spine. ........................................................... 82
`corridor and into the lumbar spine.
`82
`Claim 22 ................................................................................................................ 83
`Claim 22
`83
`i.
`[22A]—The system of claim 21, wherein when the three-bladed
`i.
`[22A]—The system of claim 21, wherein when the three-bladed
`retractor assembly is adjusted to the second position to form the
`retractor assembly is adjusted to the second position to form the
`operative corridor, the first retractor blade is the posterior-most
`operative corridor, the first retractor blade is the posterior-most
`retractor blade, the second blade is a cephalad-most retractor blade,
`retractor blade, the second blade is a cephalad-most retractor blade,
`and the third blade is a caudal-most refractor [sic] blade. ........................ 83
`and the third blade is a caudal-most refractor [sic] blade.
`83
`
`viii.
`viii.
`
`vi.
`vi.
`
`vii.
`vii.
`
`B.
`B.
`
`v v
`
`EXHIBIT 57
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`
`C.
`C.
`
`D.
`D.
`
`E.
`E.
`
`F.
`F.
`
`Claim 24 ................................................................................................................ 84
`Claim 24
`84
`i.
`[24A]—The system of claim 21, wherein said arm members of the
`i.
`[24A]—The system of claim 21, wherein said arm members of the
`blade holder assembly further comprise a translating arm member
`blade holder assembly further comprise a translating arm member
`coupled to the first retractor blade, wherein the rotation of the knob
`coupled to the first retractor blade, wherein the rotation of the knob
`element of the blade holder assembly causes the translating arm
`element of the blade holder assembly causes the translating arm
`member to linearly adjust a position of the first retractor blade
`member to linearly adjust a position of the first retractor blade
`relative to the second and third retractor blades. ...................................... 84
`relative to the second and third retractor blades.
`84
`Claim 25 ................................................................................................................ 85
`Claim 25
`85
`i.
`[25A]—The system of clam 21, wherein the three-bladed retractor
`i.
`[25A]—The system of clam 21, wherein the three-bladed retractor
`assembly includes an intradiscal shim element having a proximal
`assembly includes an intradiscal shim element having a proximal
`portion removably engageable with the first retractor blade so that
`portion removably engageable with the first retractor blade so that
`a distal portion of the shim element extends from a distal end of
`a distal portion of the shim element extends from a distal end of
`the first retractor blade and is configured to penetrate into the
`the first retractor blade and is configured to penetrate into the
`spinal disc, wherein the proximal portion of the shim element is
`spinal disc, wherein the proximal portion of the shim element is
`slidably engageable with grooves defined along the first retractor
`slidably engageable with grooves defined along the first retractor
`blade. ......................................................................................................... 85
`blade.
`85
`Claim 26 ................................................................................................................ 87
`Claim 26
`87
`i.
`[26A]- The system of claim 21, wherein the second and third
`i.
`[26A]- The system of claim 21, wherein the second and third
`retractor blades are configured to simultaneously move in response
`retractor blades are configured to simultaneously move in response
`to movement of the first and second pivotable arm members. ................. 87
`to movement of the first and second pivotable arm members.
`87
`Claim 27 ................................................................................................................ 88
`Claim 27
`88
`i.
`[27]—The system of claim 21, further comprising an elongate
`i.
`[27]—The system of claim 21, further comprising an elongate
`member deliverable to a spinal disc along a lateral, transpsoas path
`member deliverable to a spinal disc along a lateral, transpsoas path
`to the lumbar spine such that a distal tip region of the elongate
`to the lumbar spine such that a distal tip region of the elongate
`member is configured to penetrate into an annulus of the spinal
`member is configured to penetrate into an annulus of the spinal
`disc, said first dilator being configured to slidably engage an
`disc, said first dilator being configured to slidably engage an
`exterior of the elongate member. .............................................................. 88
`exterior of the elongate member.
`88
`Claim 28 ................................................................................................................ 89
`Claim 28
`89
`i.
`[28A]- The system of claim 21, wherein when the three-bladed
`i.
`[28A]- The system of claim 21, wherein when the three-bladed
`retractor assembly is in the first position, the first, second, and
`retractor assembly is in the first position, the first, second, and
`third retractor blades are in generally abutting relation with one
`third retractor blades are in generally abutting relation with one
`another....................................................................................................... 89
`another
`89
`THE ’832 PATENT .......................................................................................................... 90
`THE '832 PATENT
`90
`A.
`Claim 1 .................................................................................................................. 91
`A.
`Claim 1
`91
`i.
`[1A]- A system for forming an operating corridor to a lumbar
`i.
`[1A]- A system for forming an operating corridor to a lumbar
`spine, comprising: ..................................................................................... 91
`spine, comprising:
` 91
`[1B]- a distraction assembly to create a tissue distraction corridor
`[1B]- a distraction assembly to create a tissue distraction corridor
`in a lateral, trans-psoas path to a lumbar spine, wherein said
`in a lateral, trans-psoas path to a lumbar spine, wherein said
`distraction assembly includes an elongate inner element and a
`distraction assembly includes an elongate inner element and a
`plurality of dilators, the plurality of dilators being configured to
`plurality of dilators, the plurality of dilators being configured to
`sequentially advance along the lateral, trans-psoas path to the
`sequentially advance along the lateral, trans-psoas path to the
`
`G.
`G.
`
`14.
`14.
`
`ii.
`ii.
`
`vi vi
`
`EXHIBIT 57
`PAGE 21
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 2