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`EXHIBIT 1
`TO TRENT TANNER DECLARATION ISO
`NUVASIVE’S COMBINED MOTIONS IN LIMINE
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`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`LEV TSUKERMAN (SBN: 319184)
`ltsukerman@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`BRIAN J. NISBET (Pro Hac Vice)
`bnisbet@winston.com
`SARANYA RAGHAVAN (Pro Hac Vice)
`sraghavan@winston.com
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile: (312) 558-5700
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`
`NUVASIVE, INC., a Delaware
`corporation,
`
`Plaintiff,
`
`v.
`ALPHATEC HOLDINGS, INC., a
`Delaware corporation and
`ALPHATEC SPINE, INC., a
`California corporation,
`Defendants.
`
`Case No. 3:18-CV-00347-CAB-MDD
`[Assigned to Courtroom 4C – Honorable
`Cathy Ann Bencivengo]
`OPENING EXPERT REPORT OF
`CHARLES L. BRANCH, JR., M.D.
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`Complaint Filed: February 13, 2018
`Jury Trial Demanded
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`OPENING EXPERT REPORT OF CHARLES L. BRANCH, JR., M.D.
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`EXHIBIT 1, Page 1 of 37
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`TABLE OF CONTENTS
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`INTRODUCTION .....................................................................................................................1
`I.
`QUALIFICATIONS ..................................................................................................................1
`II.
`III. MATERIALS CONSIDERED ..................................................................................................3
`IV.
`COMPENSATION....................................................................................................................3
`V.
`PRIOR TESTIMONY ...............................................................................................................3
`VI.
`LEGAL STANDARDS .............................................................................................................4
`A.
`Anticipation ...................................................................................................................4
`B.
`Obviousness...................................................................................................................5
`C.
`The Written Description Requirement...........................................................................7
`D.
`Priority Date...................................................................................................................8
`
`PERSON OF ORDINARY SKILL IN THE ART ....................................................................8
`VII.
`VIII. BACKGROUND .......................................................................................................................9
`A.
`Overview of the Human Spine ......................................................................................9
`B.
`Development of Lateral Lumbar Interbody Fusion .....................................................10
`C.
`NuVasive’s Approach Merely Used Ubiquitous Surgical Tools to Perform
`Well-Known Minimally Invasive Lateral, Trans-Psoas Spine Surgery ......................16
`1.
`Minimally Invasive Lateral, Trans-Psoas Spine Surgery Was Well-
`Known in the Prior Art ....................................................................................16
`Sequential Dilators Were Well-Known in the Prior Art..................................19
`K-Wires Were Well-Known in the Prior Art...................................................23
`Three-Bladed Retractors Were Well-Known in the Prior Art .........................25
`Neuromonitoring Was Well-Known in the Prior Art ......................................31
`Intradiscal Shims Were Well-Known in the Prior Art.....................................34
`Other Ubiquitous Surgical Tools Used in Minimally Invasive Spinal
`Surgeries Were Well- Known in the Prior Art ................................................39
`Similar Claims in Related Patents Have Been Invalidated......................................................47
`A.
`The Board Determined that Certain Claims of Related U.S. Patent No.
`8,016,767 Were Invalid ...............................................................................................47
`The Board Determined that Certain Claims of Related U.S. Patent No.
`7,207,949 Were Invalid ...............................................................................................50
`The Board Determined that Certain Claims of Related U.S. Patent No.
`7,691,057 Were Invalid ...............................................................................................52
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`2.
`3.
`4.
`5.
`6.
`7.
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`IX.
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`B.
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`C.
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`D.
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`E.
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`The Board Determined that Certain Claims of Related U.S. Patent No.
`8,192,356 Were Invalid ...............................................................................................54
`1.
`IPR2014-00073................................................................................................55
`2.
`IPR2014-00074................................................................................................57
`The Board Determined that Certain Claims of Related U.S. Patent No.
`7,582,058 Were Invalid ...............................................................................................59
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`3.
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`5.
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`6.
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`Invalidity of the Asserted Claims ............................................................................................60
`A.
`The Asserted Claims of the ’832 Patent Would Have Been Obvious .........................60
`1.
`Claim 1 of the ’832 Patent Would Have Been Obvious Over Branch in
`view of Maeda or Büttner-Janz, further in view of Friedman,
`Kossmann, or Obenchain, and further in view of Kelleher or Blewett ...........62
`Claim 2: 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. .........................................................................................72
`Claim 3: 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.......................................................74
`Claim 4: The system of claim 1, wherein the elongate inner member
`comprises a K-wire. .........................................................................................75
`Claim 6: 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...................................................75
`Claim 7: 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............................................................................77
`Claim 8: The system of claim 1, wherein further comprising a light
`emitting device to direct light through the operative corridor toward
`the targeted spinal disc.....................................................................................79
`Claim 9: 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....................................................80
`Claim 10: 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.....................................................................................................81
`Claim 12...........................................................................................................84
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`Claim 12 Would Have Been Obvious Over Branch in view of Maeda
`or Büttner-Janz, further in view of Friedman, Kossmann, or
`Obenchain, and further in view of Kelleher or Blewett.................................. 85
`
`Claim 13: 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. ....... 95
`
`Claim 14: 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. ................................... 96
`
`Claim 16: 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 retractor
`blades. ............................................................................................................. 97
`
`Claim 17: The method of claim 12, further comprising advancing said
`elongate inner member along said lateral, trans-psoas path and into the
`disc space. ....................................................................................................... 98
`
`Claim 19: 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. .................. 99
`
`17. Motivation to Combine the Prior Art References ......................................... 102
`
`B.
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`The Asserted Claims of the ’780 Patent Would Have Been Obvious ...................... 107
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`1.
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`2.
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`3.
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`4.
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`Claim 21 of the ’780 Patent Would Have Been Obvious Over Branch
`in view of Maeda or Büttner-Janz, further in view of Friedman,
`Kossmann, or Obenchain, further in view of Kelleher or Blewett, and
`Nathanson ..................................................................................................... 108
`
`Claim 22: 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. ............................ 122
`
`Claim 24: 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. ....................................................... 123
`
`Claim 25: 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
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`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. ..................125
`Claim 26: 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. ..........................129
`Claim 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 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. .........................................................................................................130
`Claim 28: 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. ............131
`Motivation to Combine the Prior Art References..........................................133
`8.
`The Asserted Claims of the ’531 Patent Would Have Been Obvious .......................134
`1.
`Claim 1 of the ’531 Patent Would Have Been Obvious over Branch in
`view of Maeda or Büttner-Janz, further in view of Friedman,
`Kossmann, or Obenchain, further in view of Kelleher or Blewett, and
`further in view of Nathanson and Onimus.....................................................136
`Claim 2: The system of claim 1, wherein the first dilator has a length
`that is greater than the length of the second dilator. ......................................150
`Claim 3: The system of claim 2, wherein the first dilator includes a
`stimulation electrode situated at a distal end region of the first dilator
`that is electrically connectable to a nerve surveillance system for
`detecting nerves situated in the tissue along the lateral, trans-psoas
`path to the lumbar spine.................................................................................152
`Claim 4: The system of claim 2, wherein the second dilator includes a
`stimulation electrode situated at a distal end region of the second
`dilator that is electrically connectable to a nerve surveillance system
`for detecting nerves situated in the tissue along the lateral, trans-psoas
`path to the lumbar spine.................................................................................155
`Claim 5: The surgical access system of claim 4, further including a
`connector that releasably couples to a proximal connecting region of
`the first and second dilators for establishing electrical connection with
`a nerve surveillance system. ..........................................................................158
`Claim 6: The surgical access system of claim 5, wherein the spinal
`fusion implant comprises bone products or bone morphogenetic
`protein. ...........................................................................................................159
`Claim 7: The system of claim 1, further including a K-wire configured
`to extend through the first dilator and penetrate into the targeted
`intervertebral disc. .........................................................................................160
`Claim 8: The system of claim 1, wherein the first, second, and third
`retractor blades are adjacent to one another in the closed position the
`first, second, and third retractor blades abut one another. .............................161
`Claim 9: The surgical access system of claim 8, wherein the first,
`second, and third retractor blades define a distraction corridor between
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`them that is circular in cross-sectional shape when in the closed
`position. .........................................................................................................163
`Claim 10: The surgical access system of claim 9, wherein the first,
`second, and third retractor blades define a distraction corridor that is
`non-circular in cross-sectional shape when opened.......................................164
`Claim 11: The surgical access system of claim 1, wherein the first arm
`extender includes a post extending from a distal end of the first arm
`extender that is received within an opening in a proximal end of the
`first arm..........................................................................................................165
`Claim 12: The surgical access system of claim 11, wherein the second
`arm extender includes a post extending from a distal end of the second
`arm extender that is received within an opening in a proximal end of
`the second arm. ..............................................................................................168
`Claim 13: The surgical access system of claim 1, wherein moving the
`first arm extender towards the second arm extender pivots the first arm
`to move the first blade away from the second and third blades.....................170
`Claim 14: The surgical access system of claim 13, wherein moving
`the second arm extender towards the first arm extender pivots the
`second arm to move the second blade away from the first and third
`blades. ............................................................................................................171
`Claim 15: The surgical access system of claim 14, wherein the first
`arm extender and the second arm extender are squeezed together
`simultaneously to move the first blade away from the second and third
`blades simultaneously with moving the second blade away from the
`first and third blades. .....................................................................................172
`Claim 16: The surgical access system of claim 1, wherein the third
`blade extends from a proximal end having a mounting structure for
`connecting to the third connector to a distal end spaced longitudinally
`from the proximal end. ..................................................................................173
`Claim 17: The surgical access system of claim 16, wherein the third
`blade includes an exterior face and an interior face, the interior face
`including a track extending longitudinally along at least a portion of
`the interior face of the third blade for receiving a connectable element. ......174
`Claim 18: The surgical access system of claim 17, wherein the interior
`face further includes a plurality of horizontally oriented grooves
`spaced longitudinally along at least a portion of the interior face.................176
`Claim 19: The surgical access system of claim 18, wherein the track
`comprises a first longitudinally extending receptacle adjacent a first
`edge of the third blade and a second longitudinally extending
`receptacle adjacent a second edge of the third blade.....................................178
`Claim 20: The surgical access system of claim 19, wherein the
`plurality of horizontally oriented grooves lie between the first
`longitudinally extending receptacle and the second longitudinally
`extending receptacle. .....................................................................................179
`Claim 21: The surgical access system of claim 20, wherein the first
`retractor blade extends from a proximal end having a mounting
`structure for connecting to the first connector to a distal end spaced
`longitudinally from the proximal end, the interior face including a
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`track extending longitudinally along at least a portion of the interior
`face of the third blade. ...................................................................................180
`Claim 22: The surgical access system of claim 21, wherein the track
`along the interior face of the first blade comprises a first longitudinally
`extending receptacle adjacent a first edge of the first blade and a
`second longitudinally extending receptacle adjacent a second edge of
`the first blade. ................................................................................................181
`Claim 23: The surgical access system of claim 22, wherein the second
`retractor blade extends from a proximal end having a mounting
`structure for connecting to the second connector to a distal end spaced
`longitudinally from the proximal end, the interior face including a
`track extending longitudinally along at least a portion of the interior
`face of the second blade.................................................................................182
`Claim 24: The surgical access system of claim 23, wherein the track
`along the interior face of the second blade comprises a first
`longitudinally extending receptacle adjacent a first edge of the second
`blade and a second longitudinally extending receptacle adjacent a
`second edge of the second blade....................................................................183
`Claim 25: The surgical access system of claim 23, further comprising
`a light emitting element connectable to at least one of the first, second,
`and third blades..............................................................................................184
`Claim 26: The surgical access system of claim 20, wherein the
`connectable element comprises an intradiscal shim. .....................................185
`Claim 27: The surgical access system of claim 26, wherein the
`intradiscal shim includes a proximal portion that slidably engages with
`the track along the interior face of the third blade and a distal
`extension configured to extend distally beyond the distal end of the
`third retractor blade and penetrate into the targeted intervertebral disc
`when the proximal portion is advanced to a distal position along the
`third retractor blade........................................................................................187
`Claim 28: The surgical access system of claim 27, wherein the
`proximal portion includes a first longitudinally extending engagement
`element that is received in the first longitudinally extending receptacle
`and a second longitudinally extending engagement element that is
`received in the second longitudinally extending receptacle. .........................190
`Claim 29: The surgical access system of claim 28, wherein the
`proximal portion further includes a tooth situated between the first
`longitudinally extending engagement element and second
`longitudinally extending engagement element that engages with the
`horizontally extending grooves......................................................................192
`Claim 30: The surgical access system of claim 29, wherein the tooth is
`situated on a flexible tab. ...............................................................................193
`Claim 31: The surgical access system of claim 30, wherein the distal
`extension has a maximum lateral width that is less than a minimum
`lateral width of the proximal portion and a tapered distal end. .....................193
`Claim 32: The system of claim 31, further including a k-wire
`configured to extend through the first dilator and penetrate into the
`targeted intervertebral disc, and wherein the first dilator has a length
`that is greater than the length of the second dilator, the first dilator
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`including a first stimulation electrode situated at a distal end region of
`the first dilator and the second dilator including a second stimulation
`electrode situated at a distal end of the second dilator, the first
`stimulation electrode and second stimulation electrode being
`electrically connectable to a nerve surveillance system for detecting
`nerves situated in the tissue along the lateral, trans-psoas path to the
`lumbar spine...................................................................................................195
`Claim 33: The system of claim 32, wherein when the first, second,
`and third retractor blades are adjacent to one another in the closed
`position the first, second, and third retractor blades abut one another
`and define a distraction corridor between them that is circular in cross-
`sectional shape, and wherein the first, second, and third retractor
`blades define a distraction corridor that is non-circular in cross-
`sectional shape when opened.........................................................................196
`Claim 34: The surgical access system of claim 32, wherein the first
`arm extender includes a post extending from a distal end of the first
`arm extender that is received within an opening in a proximal end of
`the first arm and the second arm extender includes a post extending
`from a distal end of the second arm extender that is received within an
`opening in a proximal end of the second arm, and wherein moving the
`first arm extender towards the second arm extender pivots the first arm
`to move the first blade away from the second and third blades, and
`moving the second arm extender towards the first arm extender pivots
`the second arm to move the second blade away from the first and third
`blades. ............................................................................................................196
`Claim 35: The surgical access system of claim 34, wherein the first
`retractor blade extends from a proximal end having a mounting
`structure for connecting to the first connector to a distal end spaced
`longitudinally from the proximal end, the interior face including a
`track extending longitudinally along at least a portion of the interior
`face of the third blade, the track comprising a first longitudinally
`extending receptacle adjacent a first edge of the first blade and a
`second longitudinally extending receptacle adjacent a second edge of
`the first blade. ................................................................................................197
`Claim 36: The surgical access system of claim 35, wherein the second
`retractor blade extends from a proximal end having a mounting
`structure for connecting to the second connector to a distal end spaced
`longitudinally from the proximal end, the interior face including a
`track extending longitudinally along at least a portion of the interior
`face of the second blade, wherein the track along the interior face of
`the second blade comprises a first longitudinally extending receptacle
`adjacent a first edge of the second blade and a second longitudinally
`extending receptacle adjacent a second edge of the second blade.................197
`Claim 37: The surgical access system of claim 36, further comprising
`a light emitting element connectable to at least one of the first, second,
`and third blades..............................................................................................198
`Claim 38: The surgical access system of claim 36, further including a
`spinal fusion implant sized and shaped to insert through the operative
`corridor formed between the first, second and third retractor blades
`along the lateral, trans-psoas path..................................................................198
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`OPENING EXPERT REPORT OF CHARLES L. BRANCH, JR., M.D.
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`EXHIBIT 1, Page 8 of 37
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`Case 3:18-cv-00347-CAB-MDD Document 342-2 Filed 10/29/21 PageID.31310 Page 10 of
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`Claim 39: The surgical access system of claim 1, further including a
`spinal fusion implant sized and shaped to insert through the operative
`corridor formed between the first, second and third retractor blades
`along the lateral, trans-psoas path..................................................................198
`40. Motivation to Combine the Prior Art Reference ...........................................198
`The Asserted Claims of the ’801 Patent Would Have Been Obvious .......................201
`1.
`Claim 1 of the ’801 Patent Would Have Been Obvious Over Branch in
`view of Maeda or Büttner-Janz , further in view of Friedman,
`Kossmann, or Obenchain, further in view of Kelleher or Blewett ................203
`Claim 2: The system of claim 1, further comprising a K-wire
`configured to be advance[d] 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.....................................................220
`Claim 6: the system of claim 1, wherein at least one of said plurality
`of sequential dilators is equipped with at least one stimulation
`electrode.........................................................................................................224
`Claim 15: The system of claim 1, wherein each of the plurality of
`sequential dilators includes a stimulation electrode at a distal region...........228
`Claim 16: 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. ...............................................................................................................231
`Claim 17: 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..................................................................233
`Claim 19: 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.................................................................................................235
`Claim 20: 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. ............................................................................238
`Claim 21: The system of claim 1, wherein the second retractor blade
`includes a groove formed along said generally concave inner-facing