`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`______________________
`
`IPR2018-00935
`U.S. Patent No. 8,991,677
`______________________
`
`PATENT OWNER’S CORRECTED CONTINGENT MOTION TO AMEND
`UNDER 37 C.F.R. § 42.121
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`B.
`
`
`I.
`II.
`
`V.
`
`INTRODUCTION ........................................................................................... 1
`THE SUBSTITUTE CLAIMS DO NOT EXPAND THE SCOPE OF
`THE CLAIMS OF THE 677 PATENT ........................................................... 2
`III. PATENT OWNER PROPOSES A REASONABLE NUMBER OF
`SUBSTITUTE CLAIMS ................................................................................. 3
`IV. THE SUBSTITUTE CLAIMS DO NOT ADD NEW SUBJECT
`MATTER ......................................................................................................... 3
`THE PROPOSED SUBSTITUTE CLAIMS RESPOND TO AND
`OVERCOME THE GROUNDS OF RECORD ............................................ 17
`Substitute independent claims 19 and 24 are patentable over the
`A.
`cited art. ............................................................................................... 17
`Substitute dependent claims 20-23 are patentable over the cited
`art. ........................................................................................................ 21
`VI. CONCLUSION .............................................................................................. 21
`
`
`
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Aqua Products, Inc. v. Joseph Matal,
`872 F.3d 1290 (Fed. Cir. 2017) (en banc) ...................................................... 1, 17
`Corning Optical Comm’n RF, LLC v. PPC Broadband, Inc.,
`IPR2014-00441, Paper 19 (P.T.A.B. Oct. 30, 2014) ............................................ 3
`Statutes
`35 U.S.C. § 316(d) ............................................................................................. 1, 2, 3
`35 U.S.C. § 316(e) ................................................................................................... 17
`Other Authorities
`37 C.F.R. § 41.121 ....................................................................................... 1, 2, 3, 17
`
`
`
`
`ii
`
`
`
`LIST OF EXHIBITS
`
`Description
`U.S. Patent No. 5,964,394 (“Robertson”)
`
`U.S. Patent No. 6,231,565 (“Tovey”)
`
`Excerpts from Technology Tutorial filed in Ethicon LLC, et
`al. v. Intuitive Surgical, Inc., et al., C.A. No. 17-871
`(LPS)(CJB) (District of Delaware).
`
`Statutory Disclaimer
`
`Excerpts from the File History of U.S. Patent No. 8,991,677
`
`Declaration of Dr. William Cimino
`
`Deposition of Gregory Fischer, Ph. D., Volume 1 (February
`18, 2019)
`
`Deposition of Gregory Fischer, Ph. D., Volume 2 (February
`20, 2019)
`
`U.S. Pat. Appl. Pub. 2014/0252071 A1 (application
`publication of U.S. Appl. No. 14,283,729) (“the 729
`Application”)
`
`U.S. Pat. App. Pub. 2009/0206136 A1 (application
`publication of U.S. Appl. No. 12/031,628) (“the 628
`Application”)
`
`Reserved
`
`Reserved
`
`Reserved
`
`iii
`
`Exhibit
`Ex. 2001
`
`Ex. 2002
`
`Ex. 2003
`
`Ex. 2004
`
`Ex. 2005
`
`Ex. 2006
`
`Ex. 2007
`
`Ex. 2008
`
`Ex. 2009
`
`Ex. 2010
`
`Ex. 2011
`
`Ex. 2012
`
`Ex. 2013
`
`
`
`
`
`
`
`I.
`
`
`INTRODUCTION
`Pursuant to 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121, Patent Owner
`
`Ethicon LLC submits this contingent motion to substitute proposed claims 19-24
`
`for original claims 1-5, and 16 (collectively, the “Amended Claims”) of U.S.
`
`Patent No. 8,991,677 (“the 677 Patent”) should any of the Amended Claims be
`
`found unpatentable.1 Patent Owner has conferred with the Board prior to filing this
`
`motion, as required by 37 C.F.R. § 42.121, and the Board authorized the filing of
`
`this motion without a conference on February 25, 2019 via email.
`
`
`
`In Aqua Products, Inc. v. Joseph Matal., 872 F.3d 1290, 1327-28 (Fed. Cir.
`
`2017) (en banc), the Federal Circuit held that the burden of persuasion to establish
`
`that proposed amendments are patentable no longer rests with the patent owner.
`
`Instead, it is the petitioner’s burden to prove unpatentability of the proposed
`
`amendments. Id. In a motion to amend, a patent owner need only satisfy its burden
`
`of production under 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121.
`
`
`1 Patent Owner submitted a statutory disclaimer for claims 11-15 and 18 –
`
`accordingly, claims 11-15 and 18 are treated as having never been part of the 677
`
`Patent. See Paper 9 at 9-10. However in order to avoid confusion, Patent Owner
`
`begins numberings its substitute proposed claims at 19.
`
`
`
`1
`
`
`
`
`
`As explained below, the proposed substitute claims satisfy the requisite
`
`showing for a motion to amend. They (1) do not impermissibly enlarge the scope
`
`of the claims; (2) present a reasonable number of substitute claims; (3) do not
`
`introduce new subject matter; and (4) respond to a ground of unpatentability in the
`
`trial. Patent Owner has thus met its burden. Accordingly, should any of the
`
`Challenged Claims be determined to be unpatentable, Patent Owner respectfully
`
`requests that the 677 Patent be amended to include the corresponding substitute
`
`claim(s).
`
`II. THE SUBSTITUTE CLAIMS2 DO NOT EXPAND THE SCOPE OF
`THE CLAIMS OF THE 677 PATENT
`35 U.S.C. § 316(d)(3) and 37 C.F.R. § 42.121(a)(2)(ii) require that an
`
`
`
`amendment not “enlarge the scope of the claims of the patent . . . .” Here, the
`
`proposed substitute claims narrow—and do not broaden—the original claims.
`
`
`
`Substitute independent claims 19 and 24 include all of the original features
`
`of original independent claims 1 and 16, respectively. With respect to independent
`
`claims 1 and 16, Patent Owner has clarified in proposed independent claims 19 and
`
`24 that the claimed motor is configured for attachment to a power source
`
`independent from the means for removably attaching the housing to the surgical
`
`instrument.
`
`
`2 A full claim listing is provided in Appendix A.
`
`
`
`2
`
`
`
`
`
`Proposed dependent claims 20-23 are identical to dependent claims 2-5. The
`
`proposed claims 20-23 are, thus, narrower than the original, granted versions of
`
`those claims.
`
`III. PATENT OWNER PROPOSES A REASONABLE NUMBER OF
`SUBSTITUTE CLAIMS
`35 U.S.C. § 316(d)(1)(B) and 37 C.F.R. § 42.121(a)(3) require that, for each
`
`
`
`challenged claim, Patent Owner “propose a reasonable number of substitute
`
`claims.” There exists a “presumption . . . that only one substitute claim would be
`
`needed to replace each challenged claim.” See 37 C.F.R. § 42.121(a)(3); 35 U.S.C.
`
`§ 316(d)(1)(B); Corning Optical Comm’n RF, LLC v. PPC Broadband, Inc.,
`
`IPR2014-00441, Paper 19 at 3 (P.T.A.B. Oct. 30, 2014) (“The presumption is that
`
`only one substitute claim is needed for each original patent claim.”). Here, that is
`
`exactly what Patent Owner proposes—Patent Owner presents only one substitute
`
`claim for each challenged claim. Accordingly, Patent Owner presents a reasonable
`
`number of substitute claims.
`
`IV. THE SUBSTITUTE CLAIMS DO NOT ADD NEW SUBJECT
`MATTER
`The table below indicates where support can be found for the substitute
`
`
`
`claims from the original disclosure of the 677 Patent—U.S. Pat. App. Pub.
`
`2014/0252071 A1 (Exhibit 2009)—and from the application to which the 677
`
`Patent claims priority—U.S. Appl. No. 12/031,628 (Ex. 2010).
`
`
`
`3
`
`
`
`
`
`
`
`Claim
`
`[[1]]19. 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
`unit comprising:
`
`
`Exemplary Support in 729 and 628 Applications
`Proposed Claim 19
`See, e.g., Ex. 2009 at ¶ [0005]; Ex. 2010 at ¶ [0004] (“One
`type of surgical stapling apparatus is configured to operate
`with disposable loading units (DLU's) that are constructed to
`support a staple cartridge and knife assembly therein. Once
`the procedure is completed, the entire DLU is discarded. Such
`instruments that are designed to accommodate DLU's purport
`to offer the advantage of a “fresh” knife blade for each firing
`of the instrument. Examples of such surgical stapling
`apparatuses and DLU's are disclosed in U.S. Pat. No,
`5,865,361 entitled SURGICAL STAPLING APPARAUTS,
`which issued on Feb. 2, 1999, the disclosure of which is
`herein incorporated by reference in its entirety.)
`
`Ex. 2009 at ¶ [0009]; Ex. 2010 at ¶ [0008] (“In another
`general aspect of various embodiments of the present
`invention, there is provided a surgical cutting and stapling
`apparatus. Various embodiments of the instrument may
`include a handle assembly that operably supports a drive
`assembly therein that is constructed to impart drive motions
`and a retraction motion. A movable handle portion may be
`operably supported on the handle assembly and configured to
`interface with the drive system such that manipulation of the
`movable handle causes the drive system to impart the drive
`motions. An elongated body may protrude from the handle
`assembly and have a distal end that is couplable to a
`disposable loading unit. In various embodiments, the
`disposable loading unit may comprise a carrier that has a
`staple cartridge supported therein. An anvil assembly may be
`movably coupled to the carrier for selective movable travel
`between open and closed positions relative to the staple
`cartridge. An axial drive assembly may be supported within
`the carrier such that the axial drive assembly may move in a
`distal direction from a start position to an end position through
`the carrier and the staple cartridge and also in a proximal
`direction from the end position to the start position. A motor
`may be supported within the carrier and configured to
`
`4
`
`
`
`Claim
`
`a carrier operably
`supporting a
`cartridge assembly
`therein;
`
`Exemplary Support in 729 and 628 Applications
`interface with the axial drive assembly to drive the axial drive
`assembly in the distal and proximal directions. A battery may
`be supported within the carrier and be coupled to the motor
`for supplying power thereto. The battery may be configured to
`interface with a portion of the elongated body to receive the
`drive motions therefrom upon manipulation of the moveable
`handle.”).
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 1;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`See, e.g., Ex. 2009 at ¶ [0157]; Ex. 2010 at ¶ [0025] (“As can
`be seen in FIG. 1, the disposable loading unit 16 may
`generally comprise a tool assembly 17 for performing surgical
`procedures such as cutting tissue and applying staples on each
`side of the cut. The tool assembly 17 may include a cartridge
`assembly 18 that includes a staple cartridge 220 that is
`supported in a carrier 216.”).
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 1;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`
`5
`
`
`
`Claim
`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;
`
`
`a housing coupled
`to said carrier,
`said housing
`including means
`for removably
`attaching said
`housing to the
`surgical
`instrument;
`
`
`Exemplary Support in 729 and 628 Applications
`See, e.g., Ex. 2009 at ¶ [0157]; Ex. 2010 at ¶ [0025] (“An
`anvil assembly 20 may be pivotally coupled to the carrier 216
`in a known manner for selective pivotal travel between open
`and closed positions. The anvil assembly 20 includes an anvil
`portion 204 that has a plurality of staple deforming
`concavities (not shown) formed in the undersurface thereof.”).
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 1;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`See, e.g., Ex. 2009 at ¶ [0159]; Ex. 2010 at ¶ [0027] (“As can
`also be seen in FIG. 1, the disposable loading unit 16 may also
`have a housing portion 200 that is adapted to snap onto or
`otherwise be attached to the carrier 216. The proximal end
`500 of housing 200 may include engagement nubs 254 for
`releasably engaging elongated body 14 of a surgical stapling
`apparatus. Nubs 254 form a bayonet type coupling with the
`distal end of the elongated body portion 14 of the surgical
`stapling apparatus as described in U.S. Pat. No. 5,865,361.”)
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 1;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`
`6
`
`
`
`Claim
`a rotary drive at
`least partially
`supported within
`said housing;
`
`
`Exemplary Support in 729 and 628 Applications
`See, e.g., Ex. 2009 at ¶ [0161]; Ex. 2010 at ¶ [0029] (“As can
`also be seen in FIG. 5, the thrust disc 580 may be formed on a
`proximal end of a drive screw 600 that threadedly engages a
`drive nut 610 that is supported within an engagement section
`270 formed on the distal end of the drive beam 266. In various
`embodiments, the engagement section 270 may include a pair
`of engagement fingers 270a and 270b that are dimensioned
`and configured to be received within a slot in the drive nut
`610 to non-rotatably affix the drive nut 610 to the drive beam
`266. Thus, rotation of the drive screw 600 within the drive nut
`610 will drive the drive beam 266 in the distal direction “DD”
`or in the proximal direction “PD” depending upon the
`direction of rotation of the drive screw 600.”)
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 1;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`
`7
`
`
`
`Exemplary Support in 729 and 628 Applications
`See, e.g., Ex. 2009 at ¶ [0166]; Ex. 2010 at ¶ [0034] (“When
`the clinician desires to fire the instrument 10 (i.e., actuate the
`instrument 10 to cause it to cut and staple tissue), the clinician
`first depresses the plunger 82 of the firing lockout assembly
`80 (FIG. 1) as discussed in U.S. Pat. No. 5,865,361.
`Thereafter, movable handle 24 may be actuated. As the
`movable handle 24 is depressed, the control rod 52 moves the
`battery holder 524 and battery 526 to the position illustrated in
`FIGS. 9 and 10. As can be seen in those Figures, when the
`battery 526 is moved into that position, the battery contacts
`528, 530 are brought into contact with the fire contacts 544.
`The switch 650 is normally closed until it is actuated by the
`knife nut 610. Thus, when the battery contacts 528, 530
`contact the firing contacts 544, power flows from the battery
`526 to the motor 562 which drives the drive screw 600.”).
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 1;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`Claim
`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 for
`attachment to a
`power source
`independent of
`said housing
`connector
`attachment to the
`surgical
`instrument system,
`and wherein 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; and
`
`
`
`8
`
`
`
`Claim
`a linear member
`coupled with said
`rotary drive which
`moves axially
`upon the
`application of a
`rotary motion
`thereto from said
`motor.
`
`Exemplary Support in 729 and 628 Applications
`See, e.g., Ex. 2009 at ¶ [0166]; Ex. 2010 at ¶ [0034] (“As the
`drive screw 600 is rotated, the drive beam 266 and knife nut
`610 are driven in the distal direction “DD” to advance
`actuation sled 234 through staple cartridge 220 to effect
`ejection of staples and cutting of tissue. Once the drive beam
`266 reaches the end of the firing stroke (i.e., all of the staples
`in the staple cartridge 220 have been fired), knife nut 610 is
`positioned to actuate the normally closed switch 650 and
`move it to an open position (illustrated in FIG. 10) which
`stops the flow of power from the battery 526 to the motor 562.
`In various embodiments, a distal indication light or lights 670
`may be mounted on the housing 200 to provide an indication
`to the clinician that the drive beam 266 has reached its distal-
`most fired position.”)
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 1;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`
`
`9
`
`
`
`Claim
`
`[[2]]20. The
`disposable loading
`unit of claim 19
`[[1]], wherein said
`cartridge assembly
`comprises a
`plurality of staples
`removably stored
`therein.
`
`
`[[3]]21. The
`disposable loading
`unit of claim 20
`[[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.
`
`
`Exemplary Support in 729 and 628 Applications
`Proposed Claim 20
`See, e.g., Ex. 2009 at ¶ [0157]; Ex. 2010 at ¶ [0025] (“The
`staple cartridge 220 houses a plurality of pushers or drivers
`(not shown) that each have a staple or staples (not shown)
`supported thereon. An actuation sled 234 is supported within
`the tool assembly 17 and is configured to drive the pushers
`and staples in the staple cartridge 220 in a direction toward the
`anvil assembly 20 as the actuation sled 234 is driven from the
`proximal end of the tool assembly 17 to the distal end 220.
`See FIG. 2.”)
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 2;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`Proposed Claim 21
`See, e.g., Ex. 2009 at ¶ [0157]; Ex. 2010 at ¶ [0025] (“The
`staple cartridge 220 houses a plurality of pushers or drivers
`(not shown) that each have a staple or staples (not shown)
`supported thereon. An actuation sled 234 is supported within
`the tool assembly 17 and is configured to drive the pushers
`and staples in the staple cartridge 220 in a direction toward the
`anvil assembly 20 as the actuation sled 234 is driven from the
`proximal end of the tool assembly 17 to the distal end 220.
`See FIG. 2.”)
`
`See also id. at Abstract, Figs. 1-2, 5-10, ¶¶ [0002], [0005]–
`[0006], [0009]-[0010], [0157]–[0161], [0165]– [0166], claim
`3;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`
`10
`
`
`
`Claim
`
`[[4]]22. The
`disposable loading
`unit of claim 21
`[[3]], wherein said
`linear member
`further comprises
`a knife configured
`to incise tissue
`captured between
`said anvil and said
`cartridge
`assembly.
`
`[[5]]23. The
`disposable loading
`unit of claim 19
`[[1]], wherein said
`cartridge assembly
`is configured to be
`removed from said
`carrier and
`replaced with a
`different cartridge
`assembly.
`
`
`Exemplary Support in 729 and 628 Applications
`Proposed Claim 22
`See, e.g., Ex. 2009 at ¶ [0158]; Ex. 2010 at ¶ [0026] “The
`distal end of drive beam 266 may include a vertical support
`strut 271 which supports a knife blade 280 and an abutment
`surface 283 which engages the central portion of actuation
`sled 234 during a stapling procedure. Knife blade 280 may be
`generally positioned to translate slightly behind actuation sled
`234 through a central longitudinal slot in staple cartridge 220
`to form an incision between rows of stapled body tissue.”
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 4;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`Proposed Claim 23
`See, e.g., Ex. 2009 at ¶ [0005]; Ex. 2010 at ¶ [0004] “One
`type of surgical stapling apparatus is configured to operate
`with disposable loading units (DLU's) that are constructed to
`support a staple cartridge and knife assembly therein. Once
`the procedure is completed, the entire DLU is discarded. Such
`instruments that are designed to accommodate DLU's purport
`to offer the advantage of a “fresh” knife blade for each firing
`of the instrument. Examples of such surgical stapling
`apparatuses and DLU's are disclosed in U.S. Pat. No,
`5,865,361 entitled SURGICAL STAPLING APPARAUTS,
`which issued on Feb. 2, 1999, the disclosure of which is
`herein incorporated by reference in its entirety.”
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 5;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`
`
`11
`
`
`
`Claim
`
`[[16]]24. 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, said
`loading unit
`comprising:
`
`Exemplary Support in 729 and 628 Applications
`Proposed Claim 24
`See, e.g., Ex. 2009 at ¶ [0005]; Ex. 2010 at ¶ [0004] (“One
`type of surgical stapling apparatus is configured to operate
`with disposable loading units (DLU's) that are constructed to
`support a staple cartridge and knife assembly therein. Once
`the procedure is completed, the entire DLU is discarded. Such
`instruments that are designed to accommodate DLU's purport
`to offer the advantage of a “fresh” knife blade for each firing
`of the instrument. Examples of such surgical stapling
`apparatuses and DLU's are disclosed in U.S. Pat. No,
`5,865,361 entitled SURGICAL STAPLING APPARAUTS,
`which issued on Feb. 2, 1999, the disclosure of which is
`herein incorporated by reference in its entirety.).
`
`Ex. 2009 at ¶ [0009]; Ex. 2010 at ¶ [0008] (“In another
`general aspect of various embodiments of the present
`invention, there is provided a surgical cutting and stapling
`apparatus. Various embodiments of the instrument may
`include a handle assembly that operably supports a drive
`assembly therein that is constructed to impart drive motions
`and a retraction motion. A movable handle portion may be
`operably supported on the handle assembly and configured to
`interface with the drive system such that manipulation of the
`movable handle causes the drive system to impart the drive
`motions. An elongated body may protrude from the handle
`assembly and have a distal end that is couplable to a
`disposable loading unit. In various embodiments, the
`disposable loading unit may comprise a carrier that has a
`staple cartridge supported therein. An anvil assembly may be
`movably coupled to the carrier for selective movable travel
`between open and closed positions relative to the staple
`cartridge. An axial drive assembly may be supported within
`the carrier such that the axial drive assembly may move in a
`distal direction from a start position to an end position through
`the carrier and the staple cartridge and also in a proximal
`direction from the end position to the start position. A motor
`may be supported within the carrier and configured to
`interface with the axial drive assembly to drive the axial drive
`assembly in the distal and proximal directions. A battery may
`
`
`
`12
`
`
`
`Claim
`
`an end effector;
`
`Exemplary Support in 729 and 628 Applications
`be supported within the carrier and be coupled to the motor
`for supplying power thereto. The battery may be configured to
`interface with a portion of the elongated body to receive the
`drive motions therefrom upon manipulation of the moveable
`handle.”).
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 16;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`See, e.g., Ex. 2009 at ¶ [0004]; Ex. 2010 at ¶ [0003] (“Known
`surgical staplers include an end effector that simultaneously
`makes a longitudinal incision in tissue and applies lines of
`staples on opposing sides of the incision. The end effector
`includes a pair of cooperating jaw members that, if the
`instrument is intended for endoscopic or laparoscopic
`applications, are capable of passing through a cannula
`passageway. One of the jaw members supports a staple
`cartridge that has at least two laterally spaced rows of staples.
`The other jaw member defines an anvil having staple-forming
`pockets aligned with the rows of staples in the cartridge.”)
`
`Ex. 2009 at ¶ [0157]; Ex. 2010 at ¶ [0025] (“As can be seen in
`FIG. 1, the disposable loading unit 16 may generally comprise
`a tool assembly 17 for performing surgical procedures such as
`cutting tissue and applying staples on each side of the cut. The
`tool assembly 17 may include a cartridge assembly 18 that
`includes a staple cartridge 220 that is supported in a carrier
`216. An anvil assembly 20 may be pivotally coupled to the
`carrier 216 in a known manner for selective pivotal travel
`between open and closed positions. The anvil assembly 20
`includes an anvil portion 204 that has a plurality of staple
`deforming concavities (not shown) formed in the undersurface
`thereof.”)
`
`
`
`
`13
`
`
`
`Claim
`
`a housing
`including means
`for removably
`attaching said
`housing to the
`surgical
`instrument;
`
`a rotary drive at
`least partially
`supported within
`said housing;
`
`Exemplary Support in 729 and 628 Applications
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 16;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`See, e.g., Ex. 2009 at ¶ [0159]; Ex. 2010 at ¶ [0027] (“As can
`also be seen in FIG. 1, the disposable loading unit 16 may also
`have a housing portion 200 that is adapted to snap onto or
`otherwise be attached to the carrier 216. The proximal end
`500 of housing 200 may include engagement nubs 254 for
`releasably engaging elongated body 14 of a surgical stapling
`apparatus. Nubs 254 form a bayonet type coupling with the
`distal end of the elongated body portion 14 of the surgical
`stapling apparatus as described in U.S. Pat. No. 5,865,361.”)
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 16;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`See, e.g., Ex. 2009 at ¶ [0161]; Ex. 2010 at ¶ [0029] (“As can
`also be seen in FIG. 5, the thrust disc 580 may be formed on a
`proximal end of a drive screw 600 that threadedly engages a
`drive nut 610 that is supported within an engagement section
`270 formed on the distal end of the drive beam 266. In various
`embodiments, the engagement section 270 may include a pair
`of engagement fingers 270a and 270b that are dimensioned
`and configured to be received within a slot in the drive nut
`610 to non-rotatably affix the drive nut 610 to the drive beam
`266. Thus, rotation of the drive screw 600 within the drive nut
`610 will drive the drive beam 266 in the distal direction “DD”
`or in the proximal direction “PD” depending upon the
`direction of rotation of the drive screw 600.”)
`
`
`
`
`14
`
`
`
`Exemplary Support in 729 and 628 Applications
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 16;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`See, e.g., Ex. 2009 at ¶ [0166]; Ex. 2010 at ¶ [0034] (“When
`the clinician desires to fire the instrument 10 (i.e., actuate the
`instrument 10 to cause it to cut and staple tissue), the clinician
`first depresses the plunger 82 of the firing lockout assembly
`80 (FIG. 1) as discussed in U.S. Pat. No. 5,865,361.
`Thereafter, movable handle 24 may be actuated. As the
`movable handle 24 is depressed, the control rod 52 moves the
`battery holder 524 and battery 526 to the position illustrated in
`FIGS. 9 and 10. As can be seen in those Figures, when the
`battery 526 is moved into that position, the battery contacts
`528, 530 are brought into contact with the fire contacts 544.
`The switch 650 is normally closed until it is actuated by the
`knife nut 610. Thus, when the battery contacts 528, 530
`contact the firing contacts 544, power flows from the battery
`526 to the motor 562 which drives the drive screw 600.”).
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 16;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`Claim
`
`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 for
`attachment to a
`power source
`independent of
`said housing
`connector
`attachment to the
`surgical
`instrument system,
`and wherein such
`that said motor
`can only
`selectively receive
`power from said
`power source
`when said means
`for removably
`attaching said
`housing to the
`
`
`
`15
`
`
`
`Claim
`surgical
`instrument is
`operably coupled
`to the surgical
`instrument; and
`
`a linear member
`coupled with said
`rotary drive which
`moves axially
`upon the
`application of a
`rotary motion
`thereto from said
`motor.
`
`Exemplary Support in 729 and 628 Applications
`
`See, e.g., Ex. 2009 at ¶ [0166]; Ex. 2010 at ¶ [0034] (“As the
`drive screw 600 is rotated, the drive beam 266 and knife nut
`610 are driven in the distal direction “DD” to advance
`actuation sled 234 through staple cartridge 220 to effect
`ejection of staples and cutting of tissue. Once the drive beam
`266 reaches the end of the firing stroke (i.e., all of the staples
`in the staple cartridge 220 have been fired), knife nut 610 is
`positioned to actuate the normally closed switch 650 and
`move it to an open position (illustrated in FIG. 10) which
`stops the flow of power from the battery 526 to the motor 562.
`In various embodiments, a distal indication light or lights 670
`may be mounted on the housing 200 to provide an indication
`to the clinician that the drive beam 266 has reached its distal-
`most fired position.”)
`
`See also Ex. 2009 at Abstract, Figs. 1-2, 5-10, ¶¶ [0002],
`[0005]–[0006], [0009]-[0010], [0157]–[0161], [0165]–
`[0166], claim 16;
`Ex. 2010 at Abstract, Figs. 1-2, 5-10, ¶¶ [0001], [0004]–
`[0005], [0007]-[0008], [0025]–[0029], [0033]–[0034], claims
`1, 7-8, and 15.
`
`
`16
`
`
`
`
`
`
`
`V. THE PROPOSED SUBSTITUTE CLAIMS RESPOND TO AND
`OVERCOME THE GROUNDS OF RECORD3
`The proposed substitute claims also satisfy the last requirement for a motion
`
`
`
`to amend—they “respond to a ground of unpatentability involved in the trial.” 37
`
`C.F.R. § 42.121(a)(2). In view of Aqua Products, the burden of establishing the
`
`unpatentability of the amended claims has been placed on Petitioner. 872 F.3d at
`
`1327-28. Nevertheless, Patent Owner’s claim amendments overcome the asserted
`
`grounds of unpatentability.
`
`A.
`
`Substitute independent claims 19 and 24 are patentable over the
`cited art.
`Hooven (Ex. 1004) in combination with either Heinrich (Ex. 1005),
`
`
`
`Milliman (Ex. 1006), and/or Alesi (Ex. 1010) fails to disclose that the motor is
`
`configured for attachment to