IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patents of:
`U.S. Patent Nos.:
`
`
`Kyle P. Moore, et al.
`9,084,601
`Attorney Docket Nos.: 11030-0049IP1
`8,998,058
`11030-0049IP2
`8,991,677
`11030-0049IP3
`
`
`DETATCHABLE MOTOR POWERED SURGICAL
`INSTRUMENT
`
`
`Title:
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`DECLARATION OF DR. GREGORY S. FISCHER
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`1
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`IS 1003
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`TABLE OF CONTENTS
`
`QUALIFICATIONS ........................................................................................ 5
`I.
`II. MY UNDERSTANDING OF THE LAW ...................................................... 7
`A. Claim construction .................................................................................... 7
`B. Anticipation ............................................................................................... 7
`C. Obviousness .............................................................................................. 9
`III. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 11
`IV. BACKGROUND OF THE TECHNOLOGIES DISCLOSED IN THE
`CHALLENGED PATENTS .......................................................................... 12
`V. OVERVIEW OF THE CHALLENGED PATENTS .................................... 20
`VI. CLAIM CONSTRUCTION .......................................................................... 29
`A. “Means for removably coupling the housing to an actuator arrangement”
`(’601 patent, claim 17) ............................................................................ 29
`B. “Means for removably attaching said housing to the surgical instrument”
`(’058 patent, claim 1; ’677 patent, claims 1, 16) .................................... 30
`C. “Drive means for converting the rotational motion produced by said
`electric motor to translational motion to eject said staples from said
`staple cartridge body” (’677 patent, claims 11, 18) ................................ 30
`D. “Contact arrangement” (’601 patent, claims 1, 11, and 17) ................... 35
`E. “Means for fastening tissue on each side of a cut line” (’601 patent,
`claim 8) ................................................................................................... 37
`VII. OVERVIEW OF THE PRIOR ART ............................................................. 38
`A. Heinrich ................................................................................................... 38
`B. Milliman .................................................................................................. 42
`C. Hooven .................................................................................................... 44
`D. Alesi ...................................................................................................... 46
`E. Tonet …………………………………………………………………. 47
`VIII. THE ’601 PATENT IS INVALID ................................................................ 50
`A. Claims 1-2, 4-6, 8-11, 13, and 15-20 are anticipated by Heinrich or, if
`necessary, obvious over Heinrich in view of Milliman .......................... 50
`[1.1] A surgical cutting and stapling instrument comprising: ................ 50
`[1.2] a housing including at least one engagement member for
`removably coupling the housing to an actuator arrangement ....... 56
`[1.3] first and second jaws operably coupled to the housing such that at
`least one said jaw is selectively movable relative to the other said
`jaw ................................................................................................. 59
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[1.4] an axial drive assembly movably supported for selective axial
`travel relative to said first and second jaws .................................. 61
`[1.5] a motor supported by said housing and operably interfacing with
`the axial drive assembly to selectively move said axial drive
`assembly between a starting position and an ending position
`relative to the first and second jaws .............................................. 65
`[1.6] a contact arrangement supported by said housing and configured to
`permit power to be supplied to the motor only when the housing is
`operably attached to the actuator arrangement .............................. 70
`[2] The surgical cutting and stapling instrument of claim 1 wherein one
`of the first and second jaws operably supports a fastener cartridge
` ....................................................................................................... 74
`[4.1] The surgical cutting and stapling instrument of claim 1 wherein
`said axial drive assembly comprises ............................................. 75
`[4.2] a drive beam operably coupled to said motor ................................ 75
`[4.3] a tissue cutting edge on said drive beam ........................................ 76
`[5] The surgical cutting and stapling instrument of claim 4 wherein one
`of said first and second jaws comprises an anvil and the other of
`said first and second jaws operably supports a surgical staple
`cartridge therein ............................................................................. 77
`[6] The surgical cutting and stapling instrument of claim 5 wherein said
`drive beam includes at least one camming pin configured to move
`said anvil to a closed position when said axial drive assembly is
`axially driven from the starting position to the ending position ... 77
`[8] The surgical cutting and stapling instrument of claim 1 wherein one
`of said first and second jaws comprises means for fastening tissue
`on each side of a cut line formed therein by a portion of the axial
`drive assembly ............................................................................... 79
`[9] The surgical cutting and stapling instrument of claim 1 wherein the
`first and second jaws are axially displaced from a portion of the
`housing supporting the motor ........................................................ 80
`[10] The surgical cutting and stapling instrument of claim 9 comprising
`a shaft extending between the motor and the axial drive assembly
` ....................................................................................................... 82
`[11.1] A surgical cutting and stapling instrument comprising ............... 84
`[11.2] a housing including at least one engagement member for
`removably coupling the housing to an actuator arrangement ....... 84
`[11.3] a carrier operably coupled to the housing .................................... 84
`[11.4] a surgical staple cartridge operably supported in the carrier ....... 85
`[11.5] an anvil movably supported relative to the carrier....................... 86
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[11.6] a drive beam including a distal cutting edge supported for axial
`travel relative to the carrier ........................................................... 86
`[11.7] a motor supported by said housing and operably interfacing with
`the drive beam to selectively move said drive beam between a
`starting position and an ending position ........................................ 87
`[11.8] a contact arrangement supported by said housing and configured
`to permit power to be supplied to the motor only when the housing
`is operably attached to the actuator arrangement .......................... 87
`[13] The surgical cutting and stapling instrument of claim 11 wherein
`said drive beam includes at least one camming pin configured to
`move said anvil to a closed position when said drive beam is
`axially driven from the starting position to the ending position ... 87
`[15] The surgical cutting and stapling instrument of claim 11 wherein
`the carrier is axially displaced from a portion of the housing that
`supports the motor ......................................................................... 87
`[16] The surgical cutting and stapling instrument of claim 15 comprising
`a shaft extending between the motor and the drive beam. ............ 87
`[17.1] A surgical cutting and stapling instrument comprising ............... 87
`[17.2] an end effector configured to cut and staple tissue ...................... 87
`[17.3] a housing coupled to the end effector and including means for
`removably coupling the housing to an actuator arrangement ....... 88
`[17.4] a motor supported by said housing and operably interfacing with
`a portion of the end effector for selective actuation thereof ......... 89
`[17.5] a contact arrangement supported by said housing and configured
`to permit power to be supplied to the motor only when the housing
`is operably attached to the actuator arrangement .......................... 89
`[18] The surgical cutting and stapling instrument of claim 17 wherein
`the portion of the end effector includes a tissue cutting portion ... 89
`[19] The surgical cutting and stapling instrument of claim 17 wherein
`the motor is located proximal to the end effector within the
`housing .......................................................................................... 89
`[20] The surgical cutting and stapling instrument of claim 17 further
`comprising a shaft extending between the motor and the end
`effector portion .............................................................................. 89
`B. Claims 1-2, 4-11, and 13-20 are obvious over Heinrich in view of Alesi
`and, if necessary, Milliman ..................................................................... 89
`[7] The surgical cutting and stapling instrument of claim 4 further
`comprising a drive screw rotatably supported within the housing
`in operable engagement with the motor, the drive screw in
`threaded engagement with a portion of the drive beam ................ 90
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[10] The surgical cutting and stapling instrument of claim 9 comprising
`a shaft extending between the motor and the axial drive assembly
` ....................................................................................................... 94
`[14] The surgical cutting and stapling instrument of claim 11 further
`comprising a drive screw rotatably supported within the housing
`in operable engagement with the motor, the drive screw in
`threaded engagement with a portion of the drive beam. ............... 96
`[16] The surgical cutting and stapling instrument of claim 15 comprising
`a shaft extending between the motor and the drive beam. ............ 96
`[20] The surgical cutting and stapling instrument of claim 17 further
`comprising a shaft extending between the motor and the end
`effector portion. ............................................................................. 97
`[1]-[2], [4]-[6], [8]-[11], [13], and [15]-[20] .......................................... 97
`C. Claims 3 and 12 are obvious over Heinrich in view of Tonet and, if
`necessary, Milliman ................................................................................ 97
`[3] The surgical cutting and stapling instrument of claim 1 wherein the
`actuator arrangement comprises a portion of a handheld surgical
`instrument ...................................................................................... 97
`[12] The surgical cutting and stapling instrument of claim 11 wherein
`the actuator arrangement comprises a portion of a handheld
`surgical instrument ........................................................................ 99
`IX. THE ’058 PATENT IS INVALID ..............................................................101
`A. Claims 1-18 are obvious over Hooven in view of Heinrich .................101
`[1.1] A disposable loading unit configured for operable attachment to a
`surgical instrument configured to selectively generate at least one
`control motion for the operation of said disposable loading unit,
`said disposable loading unit comprising .....................................101
`[1.2] a carrier operably supporting a cartridge assembly therein .........104
`[1.3] an anvil supported relative to said carrier and being movable from
`an open position to closed positions upon application of at least
`one control motion thereto ..........................................................104
`[1.4] a housing coupled to said carrier, said housing including means for
`removably attaching said housing to the surgical instrument .....104
`[1.5] an axial drive assembly at least partially supported within said
`housing and being supported for selective axial travel through said
`cartridge assembly from a start position to an end position upon
`application of a rotary motion thereto, said axial drive assembly
`comprising ...................................................................................105
`[1.6] a rotary shaft .................................................................................105
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`iv
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[1.7] a motor operably interfacing with said rotary shaft to selectively
`apply said rotary motion thereto, said motor configured to receive
`power from a power source such that said motor can only
`selectively receive power from said power source when said
`means for removably attaching said housing to the surgical
`instrument is operably coupled to the surgical instrument .........105
`[2] The disposable loading unit of claim 1, wherein said cartridge
`assembly comprises a plurality of staples removably stored therein
` .....................................................................................................106
`[3] The disposable loading unit of claim 2, wherein said axial drive
`assembly comprises a sled movable between said start position
`and said end position to eject said staples from said cartridge
`assembly ......................................................................................106
`[4] The disposable loading unit of claim 3, wherein said axial drive
`assembly further comprises a knife configured to incise tissue
`captured between said anvil and said cartridge assembly ...........106
`[5] The disposable loading unit of claim 1, wherein said cartridge
`assembly is configured to be removed from said carrier and
`replaced with a different cartridge assembly ..............................106
`[6.1] A stapling system configured to be operably engaged with a
`surgical instrument system ..........................................................106
`[6.2] a staple cartridge carrier ...............................................................110
`[6.3] a staple cartridge assembly supported by said staple cartridge
`carrier ...........................................................................................111
`[6.4] an anvil supported relative to said staple cartridge carrier and
`movable from an open position to a closed position ...................112
`[6.5] a housing, wherein said staple cartridge carrier extends from said
`housing, and wherein said housing comprises a housing connector
`removably attachable to the surgical instrument system ............114
`[6.6] a rotary shaft .................................................................................118
`[6.7] an axial drive member operably engaged with said rotary shaft,
`wherein said axial drive member is selectively movable through
`said staple cartridge assembly from a start position to an end
`position when a rotary motion is applied to said rotary shaft .....118
`[6.8] an electric motor operably interfacing with said rotary shaft to
`selectively apply said rotary motion to said rotary shaft, wherein
`said electric motor is configured to receive power from a power
`source such that said electrical motor can only selectively receive
`power from said power source when said housing connector is
`attached to the surgical instrument system. .................................121
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[7] The stapling system of claim 6, wherein said staple cartridge
`assembly comprises a plurality of staples removably stored
`therein. .........................................................................................125
`[8] The stapling system of claim 7, wherein said axial drive member
`comprises a sled movable between said start position and said end
`position to eject said staples from said staple cartridge assembly.
` .....................................................................................................126
`[9] The stapling system of claim 8, wherein said axial drive member
`further comprises a knife configured to incise tissue captured
`between said anvil and said staple cartridge assembly. ..............127
`[10] The stapling system of claim 6, wherein said staple cartridge
`assembly is configured to be removed from said staple cartridge
`carrier and replaced with a different cartridge assembly. ...........128
`[11.1] A stapling system configured to be operably engaged with a
`surgical instrument system, said stapling system ........................128
`[11.2] a staple cartridge carrier .............................................................128
`[11.3] a staple cartridge body supported by said staple cartridge carrier
` .....................................................................................................128
`[11.4] a plurality of staples removably stored in said staple cartridge
`body .............................................................................................129
`[11.5] an anvil supported relative to said staple cartridge carrier and
`movable from an open position to a closed position ...................129
`[11.6] a housing, wherein said staple cartridge carrier extends from said
`housing, and wherein said housing is removably attachable to the
`surgical instrument system ..........................................................129
`[11.7] a drive system comprising ..........................................................129
`[11.7.1] a rotatable shaft comprising a threaded portion; and ..............129
`[11.7.2] a translatable drive member operably engaged with said
`threaded portion, wherein said translatable drive member is
`selectively movable through said staple cartridge body when a
`rotary motion is applied to said rotatable shaft ...........................129
`[11.8] an electric motor operably engaging said rotatable shaft to
`selectively apply said rotary motion to said rotatable shaft,
`wherein said electric motor is configured to receive power from a
`power supply only when said housing is attached to the surgical
`instrument system. .......................................................................130
`[12] The stapling system of claim 11, wherein said translatable drive
`member comprises a sled movable between a start position and an
`end position to eject said staples from said staple cartridge body.
` .....................................................................................................130
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[13] The stapling system of claim 12, wherein said translatable drive
`member further comprises a knife configured to incise tissue
`captured between said anvil and said staple cartridge body. ......130
`[14] The stapling system of claim 11, wherein said staple cartridge body
`is configured to be removed from said staple cartridge carrier and
`replaced with a different staple cartridge body. ..........................130
`[15.1] A stapling system configured to be operably engaged with a
`surgical instrument system, said stapling system ........................130
`[15.2] a staple cartridge carrier .............................................................130
`[15.3] a staple cartridge body supported by said staple cartridge carrier
` .....................................................................................................130
`[15.4] a plurality of staples removably stored in said staple cartridge
`body .............................................................................................130
`[15.5] an anvil supported relative to said staple cartridge carrier and
`movable from an open position to a closed position ...................131
`[15.6] a housing, wherein said staple cartridge carrier extends from said
`housing, and wherein said housing is removably coupled to the
`surgical instrument system ..........................................................131
`[15.7] a drive system comprising ..........................................................131
`[15.7.1] a rotatable shaft comprising a threaded portion; and ..............131
`[15.7.2] a translatable drive member operably engaged with said
`threaded portion, wherein said translatable drive member is
`selectively movable through said staple cartridge body when a
`rotary motion is applied to said rotatable shaft ...........................131
`[15.8] an electric motor system operably coupled with said rotatable
`shaft, wherein said electric motor system comprises a first state
`when said housing is coupled to the surgical instrument system
`and a second state when said housing is not coupled to the surgical
`instrument system, wherein said electric motor is configured to
`receive power from a power supply when said electrical motor
`system is in said first state, and wherein said electric motor system
`is decoupled from the power supply when said electric motor
`system is in said second state. .....................................................131
`[16] The stapling system of claim 15, wherein said translatable drive
`member comprises a sled movable between a start position and an
`end position to eject said staples from said staple cartridge body.
` .....................................................................................................134
`[17] The stapling system of claim 16, wherein said translatable drive
`member further comprises a knife configured to incise tissue
`captured between said anvil and said staple cartridge body. ......134
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`X.
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[18] The stapling system of claim 15, wherein said staple cartridge body
`is configured to be removed from said staple cartridge carrier and
`replaced with a different staple cartridge body. ..........................134
`THE ’677 PATENT IS INVALID ..............................................................135
`A. Claims 1-18 are obvious over Hooven in view of Heinrich and, if
`necessary, Milliman or Alesi ................................................................135
`[1.1] A disposable loading unit configured to be operably attached to a
`surgical instrument which is configured to selectively generate at
`least one control motion for the operation of said disposable
`loading unit, said disposable loading comprising .......................135
`[1.2] a carrier operably supporting a cartridge assembly therein .........135
`[1.3] an anvil supported relative to said carrier and being movable from
`an open position to closed positions upon application of at least
`one control motion thereto ..........................................................135
`[1.4] a housing coupled to said carrier, said housing including means for
`removably attaching said housing to the surgical instrument .....135
`[1.5] a rotary drive at least partially supported within said housing ....136
`[1.6] a motor supported within said housing and operably interfacing
`with said rotary drive to selectively apply a rotary motion thereto,
`wherein said motor is configured to receive power from a power
`source such that said motor can only selectively receive power
`from said power source when said means for removably attaching
`said housing to the surgical instrument is operably coupled to the
`surgical instrument ......................................................................137
`[1.7] a linear member coupled with said rotary drive which moves
`axially upon the application of a rotary motion thereto from said
`motor ............................................................................................138
`[2] The disposable loading unit of claim 1, wherein said cartridge
`assembly comprises a plurality of staples removably stored
`therein. .........................................................................................146
`[3] The disposable loading unit of claim 2, wherein said linear member
`comprises a sled movable between a start position and an end
`position to eject said staples from said cartridge assembly ........146
`[4] The disposable loading unit of claim 3, wherein said linear member
`further comprises a knife configured to incise tissue captured
`between said anvil and said cartridge assembly ..........................146
`[5] The disposable loading unit of claim 1, wherein said cartridge
`assembly is configured to be removed from said carrier and
`replaced with a different cartridge assembly ..............................147
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`viii
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[6.1] A stapling sub-system configured to be operably engaged with a
`surgical instrument system, said stapling sub-system comprising
` .....................................................................................................147
`[6.2] a staple cartridge carrier ...............................................................147
`[6.3] a staple cartridge assembly supported by said staple cartridge
`carrier ...........................................................................................147
`[6.4] an anvil supported relative to said staple cartridge carrier and
`movable from an open position to a closed position ...................147
`[6.5] a housing, wherein said staple cartridge carrier extends from said
`housing, and wherein said housing comprises a housing connector
`removably attachable to the surgical instrument system ............147
`[6.6] a rotary drive system, comprising ................................................147
`[6.6.1] a rotary shaft ..............................................................................148
`[6.6.2] a translatable drive member operably engaged with said rotary
`shaft, wherein said translatable drive member is selectively
`translatable through said staple cartridge assembly from a start
`position to an end position when a rotary motion is applied to said
`rotary shaft ...................................................................................148
`[6.6.3] an electric motor operably interfacing with said rotary shaft to
`selectively apply said rotary motion to said rotary shaft, wherein
`said electric motor is operably disconnected from a power source
`when said housing is not attached to the surgical instrument
`system, and wherein said electric motor is operably connected to
`the power source when said housing is attached to the surgical
`instrument system. .......................................................................148
`[7] The stapling sub-system of claim 6, wherein said staple cartridge
`assembly comprises a plurality of staples removably stored
`therein. .........................................................................................150
`[8] The stapling sub-system of claim 7, wherein said translatable drive
`member comprises a sled movable between said start position and
`said end position to eject said staples from said staple cartridge
`assembly. .....................................................................................150
`[9] The stapling sub-system of claim 8, wherein said translatable drive
`member further comprises a knife configured to incise tissue
`captured between said anvil and said staple cartridge assembly.151
`[10] The stapling sub-system of claim 6, wherein said staple cartridge
`assembly is configured to be removed from said staple cartridge
`carrier and replaced with a different staple cartridge assembly. .151
`
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[11.1] A stapling attachment configured to be operably attached to a
`surgical instrument system, said stapling attachment comprising:
` .....................................................................................................151
`[11.2] a staple cartridge carrier .............................................................151
`[11.3] a staple cartridge body supported by said staple cartridge carrier,
`wherein said staple cartridge body comprises a proximal end and a
`distal end ......................................................................................151
`[11.4] a plurality of staples removably stored in said staple cartridge
`body .............................................................................................151
`[11.5] an anvil supported relative to said staple cartridge carrier and
`movable from an open position to a closed position ...................151
`[11.6] a housing, wherein said staple cartridge carrier extends from said
`housing, and wherein said housing is removably attachable to the
`surgical instrument system ..........................................................152
`[11.7] an electric motor configured to produce rotational motion,
`wherein said electric motor selectively receives power from a
`power source only when said housing is coupled to said surgical
`instrument system ........................................................................152
`[11.8] drive means for converting the rotational motion produced by
`said electric motor to translational motion to eject said staples
`from said staple cartridge body ...................................................153
`[12] The stapling attachment of claim 11, wherein said drive means
`comprises a sled movable between a proximal position and a distal
`position to eject said staples from said staple cartridge body .....155
`[13] The stapling attachment of claim 12, wherein said drive means
`further comprises a knife configured to incise tissue captured
`between said anvil and said staple cartridge body ......................155
`[14] The stapling attachment of claim 11, wherein said staple cartridge
`body is configured to be removed from said staple cartridge carrier
`and replaced with a different staple cartridge body ....................155
`[15] The stapling attachment of claim 11, wherein the translational
`motion is directed toward said distal end ....................................155
`[16.1] A loading unit configured to be operably attached to a surgical
`instrument which is configured to selectively generate at least one
`control motion for the operation of said loading unit .................155
`[16.2] an end effector ............................................................................156
`[16.3] a housing including means for removably attaching said housing
`to the surgical instrument ............................................................156
`[16.4] a rotary drive at least partially supported within said housing ..156
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`Attorney Docket No. 11030-0049IP1 through IP3
`IPR of U.S. Patent Nos. 9,084,601, 8,998,058, and 8,991,677
`[16.5] a motor supported within said housing and operably interfacing
`with said rotary drive to selectively apply a rotary motion thereto,
`wherein said motor is configured to receive power from a power
`source such that said motor can only selectively receive power
`from said power source when said means for removably attaching
`said housing to the surgical instrument is operably coupled to the
`surgical instrument ......................................................................156
`[16.6] a linear member coupled with said rotary drive which moves
`axially upon the application of a rotary motion thereto from said
`motor............................................................................................157
`[17.1] A stapling sub-system configured to be operably engaged with a
`surgical instrument system, said stapling sub-system comprising
` ................................................................................