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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`
`INTUITIVE SURGICAL, INC.
`Petitioner
`v.
`ETHICON LLC
`Patent Owner
`
`
`Case IPR2018-00934
`Patent 8,998,058
`
`
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`PETITIONER’S OPPOSITION TO
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`PATENT OWNER’S CONTINGENT MOTION TO AMEND
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`TABLE OF CONTENTS
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`I.
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`II.
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`INTRODUCTION ........................................................................................... 1
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`THE SUBSTITUTE CLAIMS INTRODUCE NEW MATTER .................... 1
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`III.
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`THE SUBSTITUTE CLAIMS ARE OBVIOUS ............................................ 3
`
`A.
`
`Substitute claims 19-22 and 24-27 are obvious over Viola in view of
`Heinrich ................................................................................................. 3
`Substitute clams 23 and 28 are obvious over Viola in view of Heinrich
`and, if necessary, further in view of Young ........................................ 18
`IV. CONCLUSION .............................................................................................. 20
`
`B.
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`i
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`IS1001
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`IS1002
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`IS1003
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`IS1004
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`IS1005
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`IS1006
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`IS1007
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`IS1008
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`IS1009
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`IS1010
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`IS1011
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`IS1012
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`IS1013
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`EXHIBITS
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`U.S. Patent No. 8,998,058 to Moore, et al. (“the ’058 patent”)
`
`Excerpts from the prosecution histories of U.S. Pat. Nos.
`9,084,601 (Serial No. 13/832,522), 8,998,058 (Serial No.
`14/282,494), 8,991,677 (Serial No. 14/283,729), 8,752,749
`(Serial No. 13/118,210), 8,196,795 (Serial No. 12/856,099), and
`7,793,812 (Serial No. 12/031,628)
`
`Declaration of Dr. Gregory S. Fischer
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`U.S. Patent No. 5,383,880 to Hooven (“Hooven”)
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`U.S. Patent App. Pub. No. 2005/0131390 to Heinrich et al.
`(“Heinrich”)
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`U.S. Patent No. 5,865,361 to Milliman et al. (“Milliman”)
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`U.S. Patent No. 7,524,320 to Tierney et al. (“the ’320 patent”)
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`U.S. Patent No. 8,196,795 to Moore et al. (“the ’795 patent”)
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`U.S. Patent No. 8,752,749 to Moore et al. (“the ’749 patent”)
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`U.S. Patent No. 5,779,130 to Alesi et al. (“Alesi”)
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`[Reserved]
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`[Reserved]
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`U.S. Patent No. 6,783,524 to Anderson et al. (“the ’524 patent”)
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`IS1014-IS1028
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`Reserved
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`IS1029
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`Webster’s Ninth New Collegiate Dictionary (1991)
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`ii
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`IS1030
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`IS1031
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`IS1032
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`Supplemental Declaration of Gregory S. Fischer (“Fischer
`Supp. Decl.”)
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`U.S. Pat. No. 5,954,259 to Viola et al. (“Viola”)
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`U.S. Pat. No. 5,653,374 to Young et al. (“Young”)
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`IS1033
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`
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`Transcript of deposition of Dr. William Cimino, May 29, 2019
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`iii
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`I.
`
`INTRODUCTION
`The Board should deny Patent Owner’s Contingent Motion to Amend
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`(“MTA”) seeking to substitute proposed claims 19-28 (“substitute claims”) for
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`original claims 1-10. MTA at 1. For the reasons discussed below, Petitioner re-
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`quests that the Board deny the MTA because each substitute claim: (1) introduces
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`new matter; and (2) is obvious over the prior art.
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`II. THE SUBSTITUTE CLAIMS INTRODUCE NEW MATTER
`An MTA may not present substitute claims that introduce new subject
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`matter. 35 U.S.C. § 316(d); 37 C.F.R. § 42.121(A)(2)(ii). New matter is any
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`addition to the claims without support in the original disclosure. TurboCare Div.
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`of Demag Delaval Turbomach. v. Gen. Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir.
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`2001). And a claim element without support in the original disclosure merits a
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`rejection under 35 U.S.C. § 112 for lack of written description support. In re
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`Rasmussen, 650 F.2d 1212, 1214 (C.C.P.A. 1981). When amending a claim to add
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`a new claim element, the disclosure as filed must “actually or inherently disclose
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`the claim element” to satisfy the written description requirement. PowerOasis,
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`Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008). And
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`pursuant to 35 U.S.C. § 316(d), the Board may properly consider Section 112 and
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`rely on it to reject proposed substitute claims, as it should here. See, e.g., Apple
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`Inc. v. Valencell, Inc., Case No. IPR2017-00315, Paper 45 at 44 (PTAB May 31,
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`1
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`2018) (“[W]e agree with Petitioner that the proposed substitute claims do not pass
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`muster under 35 U.S.C. § 112 because they are indefinite.”).
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`Here, each of the substitute claims includes the following amendment: “said
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`motor configured to receive power from for attachment to a power source
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`independent of said housing connector attachment to the surgical instrument
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`system, and wherein such that.” MTA at 14, 22. However, this amendment does
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`not have written description support (and thus introduces new matter) because the
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`portions of the ’058 patent and all of its priority applications identified by Patent
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`Owner clearly teach the opposite; namely, that “attachment” of the power source to
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`the motor (i.e., an electrical connection that allows current to flow there between)
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`is dependent on the housing connector’s attachment to the surgical instrument
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`system.
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`More specifically, the ’058 patent discloses that “switch portion 520 …
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`movably houses a battery 526 therein,” (shown in Fig. 3) and switch portion 520 is
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`configured to move between a contact state and a non-contact state depending on
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`whether the disposable loading unit is attached to the handheld surgical cutting and
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`stapling instrument 10. ’058 patent, 11:29-48; Fischer Supp. Decl., ¶¶33-36.
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`Accordingly, the ’058 patent discloses no means for “attaching” the motor to
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`the power source apart from attaching the housing of the disposable loading unit or
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`the tool mounting portion to the surgical instrument system. Id. Consequently,
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`“attachment” of the motor to the power source is necessarily dependent on the
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`housing connector’s attachment to the surgical instrument system, in direct
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`contradiction with the requirements of the amended claims.
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`In sum, the alternative embodiment contemplated by the substitute claims
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`has no written description support in the ’058 patent and thus constitutes the
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`impermissible introduction of new matter.
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`III. THE SUBSTITUTE CLAIMS ARE OBVIOUS
`A.
`Substitute claims 19-22 and 24-27 are obvious over Viola in view
`of Heinrich
`Viola discloses a surgical cutting and stapling instrument (surgical stapler
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`10) in which the power source (power cells 45a-b) and the motor (motor assembly
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`22) both reside within the same housing (handle 12, excluding trigger 44). The
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`power cells 45a-b and motor assembly 22 are highlighted in red, the housing is
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`highlighted in yellow, and trigger 44 is highlighted in blue in Figure 2a below.
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`Fischer Supp. Decl., ¶¶38-40; Viola, Abstract, 4:18-57, Figs. 1, 2a.
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`Proceeding No. IPR2018-00934
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`Motor
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`Housing
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`Trigger (replaceable with electro-
`mechanical assembly 619)
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`It would have been obvious in view of Heinrich to combine Viola’s
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`Power source
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`
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`instrument 10 with Heinrich’s surgical instrument system (actuation assembly 612,
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`monitor 614, and robot 616). Fischer Supp. Decl., ¶¶41-50; see also IPR2018-
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`00934, Paper No. 9 (instituting review on the basis that the challenged claims
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`would have been obvious over Heinrich in view of Hooven’s motor-powered
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`surgical stapler); IPR2018-00935, Paper No. 9 at 23-27 (same). Specifically, it
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`would have been obvious to (1) incorporate the components inside Viola’s handle
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`12 (e.g., motor assembly 22 and power cells 45a-b) into Heinrich’s housing, and
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`(2) replace or actuate Viola’s trigger 44 with Heinrich’s electromechanical
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`assembly 619, which is also included in the housing of disposable loading unit 618
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`and is controlled by Heinrich’s robotic system as shown below in Figure 8. Id.
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`Disposable loading unit 618
`containing electromechanical
`assembly 619
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`Robot arm 616 of ro-
`botic system that con-
`trols electromechani-
`cal assembly 619
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`The resulting device (the Viola/Heinrich loading unit, highlighted in yellow)
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`is shown below connected to Heinrich’s robotic arm in the composite image of
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`Heinrich’s Fig. 9 with Viola’s Fig. 1:
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`Housing, which includes
`motor and power source
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`Trigger (replaceable
`with Heinrich’s elec-
`tro-mechanical actu-
`ation assembly 619)
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`
`
`Heinrich’s housing of head
`portion 640, including elec-
`tromechanical assembly 619,
`modified to include Viola’s
`motor and power source
`When, as here, “there are a finite number of identified, predictable solutions,
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`
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`a person of ordinary skill has good reason to pursue the known options within his
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`or her technical grasp.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`In this case, Viola describes one predictable solution for manipulating the surgical
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`instrument (by hand) and Heinrich describes another predictable solution (using a
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`robotic system). Heinrich, ¶132, Fig. 7; Fischer Supp. Decl., ¶43.
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`A POSITA would have been motivated to configure Viola’s instrument 10
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`for operable attachment to Heinrich’s robotic system for several reasons.1 For
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`example, as shown by Heinrich, making a handheld surgical stapler compatible
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`with a robotic system was desirable. Fischer Supp. Decl., ¶¶44-47. Indeed,
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`Heinrich expressly motivates replacing one or more manual actuators, e.g., as
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`shown below in Heinrich’s Figure 1, with electromechanical assembly 619, which
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`is controlled by Heinrich’s robotic system as shown above in Figure 8. Id.
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`Housing
`
`Fig. 1
`
`Fig. 9
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`Actuators replaceable with
`robot-controlled electro-
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`mechanical assembly 619
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`Housing, which includes
`robot-controlled electro-
`mechanical assembly 619
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`
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`1 See also IPR2018-00934, Paper No. 9 at 20 (“Petitioner demonstrates adequate
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`reasoning to combine the teachings of Hooven with Heinrich”); IPR2018-00935,
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`Paper No. 9 at 24 (same).
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`Proceeding No. IPR2018-00934
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`Heinrich provides additional examples of replacing the manual actuators of various
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`handheld tools with a robotically controlled electromechanical assembly 619 to
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`create loading units that can be removably attached to the robotic system. Compare
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`Heinrich, Figs. 5, 6 with Heinrich, Figs. 11, 10; see also Petition at 27 (illustrating
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`same). And Heinrich specifically envisions the use of “locally powered” surgical
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`instruments, like the instruments disclosed in Viola. Heinrich, ¶131; Fischer Supp.
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`Decl., ¶46. Accordingly, a POSITA would have recognized that Heinrich’s robotic
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`system is an effective and efficient mechanism for manipulating handheld surgical
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`staplers, like Viola’s instrument 10. Fischer Supp. Decl., ¶47.
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`Further motivation, as recognized by the ’058 patent, is provided by the
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`prior art teaching that “[m]any [robotic] systems are disclosed in [the prior art]”
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`and that “robotic (or ‘telesurgical’) systems . . . increase surgical dexterity [and]
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`permit a surgeon to operate on a patient in an intuitive manner.” ’058 patent,
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`14:60-63; see also Anderson, 2:37-55 (describing advantages of robotic systems
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`over manual systems; e.g. “The surgeon can [also] typically perform the surgical
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`procedure at [a] location remote from the patient”). Notably, that same prior art
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`also teaches that loading units for robotic systems “may include OEM parts” from
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`handheld instruments, like the parts disclosed in Viola, “to reduce costs and for
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`manufacturing convenience.” Anderson, 7:6-7, see also 15:8-13. Thus, like the
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`inventors in Anderson, a POSITA modifying Viola’s instrument for use with
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`Proceeding No. IPR2018-00934
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`Heinrich’s robotic system would not move Viola’s power source into Heinrich’s
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`robotic system because such a modification would significantly increase the cost
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`and complexity of the task. Fischer Supp. Decl., ¶¶48-49.
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`Moreover, such a modification of Viola would have been well within a
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`POSITA’s abilities. Indeed, it would have been merely the application of a known
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`technique (adapting a handheld surgical instrument for use with a robotic system
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`by replacing manually actuatable triggers with robotically controlled actuators) to a
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`known system (Viola’s instrument) in the same field of endeavor (surgical staplers)
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`in a known way. Fischer Supp. Decl., ¶50; Anderson, 7:6-15; 18:25-49, Figs., 4-9,
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`12A-D, 20, 26-36; Heinrich, Figs. 1, 5, 6, 9-12; KSR, 550 U.S. at 417; see also
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`’058 patent, 16:40-47 (conceding that a POSITA would have known how to use a
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`“wide variety of alternative robotic structures.”). In combination, each element
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`(Heinrich’s robot and Viola’s instrument) merely performs the same function as it
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`does separately. Fischer Supp. Decl., ¶50. And the combination of Viola and
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`Heinrich proposed here would have yielded predictable results without
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`significantly altering or hindering the functions performed by Viola’s device. Id.
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`As shown in the claim chart below, the Viola/Heinrich loading unit discloses
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`each limitation of substitute claims 19-22 and 24-27.
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`Proceeding No. IPR2018-00934
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`8
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`Fig. 5
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`
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`channel 80)
`cartridge carrier (housing
`90) supported by the staple
`(fastener retaining cartridge
`Staple cartridge assembly
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`See, e.g., Viola, 5:59-6:59, Fig. 5; Fischer Supp. Decl., ¶¶87, 121.
`
`
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`staple cartridge carrier;
`assembly supported by said
`[24.3] a staple cartridge
`
`(housing channel 80)
`Staple cartridge carrier
`See, e.g., Viola, 5:44-6:20, 7:14-55, Figs. 5, 8. Fischer Supp. Decl., ¶¶86, 120.
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`carrier;
`[24.2] a staple cartridge
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`
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`¶¶107, 119.
`See, e.g., Viola, Abstract, Fig. 1; Heinrich, Figs. 1-4, 8-9; Fischer Supp. Decl.,
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`Substitute claims 24-28
`
`Viola/Heinrich loading unit
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`a surgical instrument system (Heinrich’s robotic surgical system)
`ably engaged (via attachment platform 642 and mounting flange 636) with
`A stapling system (the Viola/Heinrich loading unit) configured to be oper-
`
`
`
`stapling system comprising:
`instrument system, said
`engaged with a surgical
`configured to be operably
`[24.1] A stapling system
`
`Substitute Claims
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`9
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`(axial drive screw 78)
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`Rotary shaft
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`
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`Fig. 5
`
`
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`124.
`See, e.g., Viola, 5:43-7:13, 7:56-8:16, Figs. 5, 9-10; Fischer Supp. Decl., ¶¶80,
`portion of the housing
`tends from the shaft 14
`(housing channel 80) ex-
`Staple cartridge carrier
`
`tachable to the surgical instrument system
`642 and protrusions 638) removably at-
`Housing connector (attachment platform
`
`Housing (housing of head portion 640 and shaft 14)
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`Fischer Supp. Decl., ¶¶54-61, 123.
`See, e.g., Heinrich, ¶134, Fig. 7; Viola, 4:18-39, Figs. 1-2a; Petition at 51-52;
`
`
`
`Fig. 5
`
`an open position to a closed position
`flanges 84a and 84b and movable from
`tive to the staple cartridge carrier by
`Anvil (anvil member 86) supported rela-
`
`122.
`See, e.g., Viola, 6:3-20, Figs. 5, 9-10; Fischer Supp. Decl., ¶¶59-61, 79, 86,
`Viola/Heinrich loading unit
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`[24.6] a rotary shaft;
`
`surgical instrument system;
`removably attachable to the
`comprises a housing connector
`wherein said housing
`from said housing, and
`staple cartridge carrier extends
`[24.5] a housing, wherein said
`
`position;
`open position to a closed
`carrier and movable from an
`relative to said staple cartridge
`[24.4] an anvil supported
`Substitute Claims
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`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`10
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`113-15, 126.
`See, e.g., Viola, 4:40-5:12, 7:56-8:16, Figs. 2a-b; Fischer Supp. Decl., ¶¶65-73,
`
`
`
`position
`Ending
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`
`position
`Starting
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`
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`said rotary shaft, wherein said
`apply said rotary motion to
`rotary shaft to selectively
`operably interfacing with said
`[24.8] an electric motor
`
`tion when a rotary motion is applied to the rotary shaft (36)
`tridge assembly (34) from a start (proximal) position to an end (distal) posi-
`with the rotary shaft (78) and selectively movable through the stapler car-
`104, beam 100, follower housing 95, and follower nut 94) operably engaged
`Axial drive member (cutting blade 130, sled 120, cam beam 108, cam roller
`
`
`
`
`
`
`
`Axial drive screw 78
`
`Fig. 5
`
`See, e.g., Viola, 5:44-7:13, Fig. 5; Fischer Supp. Decl., ¶¶62-70, 125.
`Viola/Heinrich loading unit
`
`and
`applied to said rotary shaft;
`when a rotary motion is
`position to an end position
`cartridge assembly from a start
`movable through said staple
`drive member is selectively
`rotary shaft, wherein said axial
`operably engaged with said
`[24.7] an axial drive member
`Substitute Claims
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`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`11
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`
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`and cartridge coupling 76
`via gear set 24, drive shaft 42,
`faces with the rotary shaft (78)
`The motor (22) operably inter-
`
`
`
`Motor assembly 22
`
`
`
`Viola, Figs. 2, 8, 9
`
`screw 78
`Axial drive
`
`
`
`
`
`Viola, Fig. 2a Viola/Heinrich loading unit
`
`
`
`der Patent Owner’s apparent construction of this term.
`nector attachment to the surgical instrument system un-
`power source (45a-b) independent of the housing con-
`motor (22) is thus configured for “attachment” to the
`640 of the Viola/Heinrich loading unit’s housing. The
`(power cells 45a-b) are both included in head portion
`Viola’s motor (motor assembly 22) and power source
`
`Viola/Heinrich loading unit
`
`system.
`to the surgical instrument
`housing connector is attached
`said power source when said
`selectively receive power from
`electrical motor can only
`system, and wherein said
`to the surgical instrument
`housing connector attachment
`source independent of said
`for attachment to a power
`electric motor is configured
`Substitute Claims
`
`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`12
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`
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`the Viola/Heinrich loading unit is attached to the robotic system.
`619 that replaces trigger 44 to move link bar 48 can only be actuated when
`source to the motor, but the robot-controlled electromechanical assembly
`minals T5, T6 (or T1, T2) to permit power to be supplied from the power
`link bar 48 must be moved to connect terminals T3, T4 with respective ter-
`the housing connector is attached to the surgical instrument system because
`The motor can only selectively receive power from the power source when
`
`
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`
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`Viola, Fig. 2b
`
`motor and the power source
`assembly 46 to connect the
`T6 (or T1, T2) in switching
`with respective terminals T5,
`nects middle terminals T3, T4
`Movement of link bar 48 con-
`
`
`
` Viola, Fig. 2a Viola/Heinrich loading unit
`
`
`
`
`sembly 619, controls switching assembly 46.
`and distally by Heinrich’s electromechanical as-
`housing. Link bar 48, which is moved proximally
`also included in the Viola/Heinrich loading unit’s
`Viola’s switching assembly 46 and link bar 48 are
`
`Viola/Heinrich loading unit
`
`Substitute Claims
`
`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`13
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`
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`8-9; Petition at 49-50; Fischer Decl., ¶191; Fischer Supp. Decl., ¶107.
`See, e.g., Viola, Abstract, Figs. 1-2; Heinrich, ¶¶132-33, 136-37, 191, Figs. 1-4,
`
`Substitute claims 19-23
`
`Supp. Decl., ¶¶62-64, 77, 129.
`See element [24.7] (cutting blade 130); see also Viola, 6:40-44, Fig. 5; Fischer
`
`128.
`See element [24.7] (sled 120); Viola, 6:29-32; Fischer Supp. Decl., ¶¶62-70,
`
`See, e.g., Viola, 5:59-6:59, Fig. 5; Fischer Supp. Decl., ¶¶81, 127.
`Viola/Heinrich loading unit
`
`one control motion for the
`selectively generate at least
`instrument configured to
`attachment to a surgical
`unit configured for operable
`[19.1] A disposable loading
`
`staple cartridge assembly.
`between said anvil and said
`to incise tissue captured
`comprises a knife configured
`drive member further
`claim 26, wherein said axial
`[27] The stapling system of
`assembly.
`from said staple cartridge
`position to eject said staples
`start position and said end
`sled movable between said
`drive member comprises a
`claim 25, wherein said axial
`[26] The stapling system of
`removably stored therein.
`a plurality of staples
`cartridge assembly comprises
`claim 24, wherein said staple
`[25] The stapling system of
`Substitute Claims
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`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`14
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`
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`instrument”).
`claimed “means for removably attaching said housing to the surgical
`patent’s engagement nubs 254,” which is a structure corresponding to the
`protrusions 638 are “the same as, or, at a minimum, equivalent to, the ’058
`See elements [24.5]; see also Petition at 51-52 (explaining why Heinrich’s
`
`104) thereto).
`upon application of at least one control motion (e.g., the motion of cam roller
`(confirming that the anvil is movable from an open position to closed positions
`See elements [24.4] (anvil); see also Viola, 6:60-67, 7:56-8:16, Figs. 5, 9-10
`
`See elements [24.2]-[24.3].
`
`
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`loading unit) for the operation of said disposable loading unit
`ment of electro-mechanical assembly 619 to operate, the Viola/Heinrich
`least one control motion (e.g., the movements to position, and the move-
`Heinrich’s robotic surgical system is configured to selectively generate at
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`
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`instrument;
`housing to the surgical
`removably attaching said
`including means for
`said carrier, said housing
`[19.4] a housing coupled to
`one control motion thereto;
`upon application of at least
`position to closed positions
`being movable from an open
`relative to said carrier and
`[19.3] an anvil supported
`assembly therein;
`supporting a cartridge
`[19.2] a carrier operably
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`636) to a surgical instrument (Heinrich’s robotic surgical system)
`operable attachment (via attachment platform 642 and mounting flange
`A disposable loading unit (the Viola/Heinrich loading unit) configured for
`
`Viola/Heinrich loading unit
`
`loading unit comprising:
`loading unit, said disposable
`operation of said disposable
`Substitute Claims
`
`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`15
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`
`
`
`
`See element [24.8].
`See element [24.6].
`
`Decl., ¶¶62-64, 111.
`supported on axial drive screw 78 for selective axial travel. Id.; Fischer Supp.
`within the shaft portion of the Viola/Heinrich loading unit’s housing and
`follower nut 94 is an axial drive assembly that is at least partially supported
`cam beam 108, cam roller 104, actuation beam 100, and follower housing 95,
`See element [24.7]. The combination of Viola’s cutting blade 130, sled 120,
`Viola/Heinrich loading unit
`
`to the surgical instrument.
`instrument is operably coupled
`housing to the surgical
`removably attaching said
`source when said means for
`ceive power from said power
`motor can only selectively re-
`ment system, and wherein said
`ment to the surgical instru-
`said housing connector attach-
`power source in-dependent of
`configured for attachment to a
`motion thereto, said motor
`selectively apply said rotary
`facing with said rotary shaft to
`[19.6] a motor operably inter-
`[19.5.1] a rotary shaft; and
`assembly comprising
`thereto, said axial drive
`application of a rotary motion
`to an end position upon
`assembly from a start position
`travel through said cartridge
`supported for selective axial
`within said housing and being
`at least partially supported
`[19.5] an axial drive assembly
`Substitute Claims
`
`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`16
`
`
`
`
`
`See element [24.5], claim [27].
`
`See element [24.5], claim [26].
`
`See element [25].
`Viola/Heinrich loading unit
`
`cartridge assembly.
`between said anvil and said
`to incise tissue captured
`comprises a knife configured
`axial drive assembly further
`unit of claim 21, wherein said
`[22] The disposable loading
`assembly.
`staples from said cartridge
`said end position to eject said
`between said start position and
`comprises a sled movable
`axial drive assembly
`unit of claim 20, wherein said
`[21] The disposable loading
`removably stored therein.
`a plurality of staples
`cartridge assembly comprises
`unit of claim 19, wherein said
`[20] The disposable loading
`Substitute Claims
`
`
`
`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`17
`
`
`
`B.
`
`Substitute clams 23 and 28 are obvious over Viola in view of Hein-
`rich and, if necessary, further in view of Young
`Claims 23 and 28 each recites “wherein said cartridge assembly is config-
`
`ured to be removed from said carrier and replaced with a different cartridge assem-
`
`bly.” It would have been obvious in view of Young to modify the Viola/Heinrich
`
`loading unit to use an end effector with a staple cartridge assembly configured to
`
`be removed from the staple cartridge carrier and replaced with a different cartridge
`
`assembly. Fischer Supp. Decl., ¶¶13-36.
`
`When, as here, “there are a finite number of identified, predictable solutions,
`
`a person of ordinary skill has good reason to pursue the known options within his
`
`or her technical grasp.” KSR, 550 U.S. at 421. Indeed, at the time of the alleged
`
`invention, there were two solutions for replacing a staple cartridge in a surgical sta-
`
`pler—replacing the cartridge or replacing a loading unit containing the cartridge.
`
`Fischer Supp. Decl., ¶132. Viola describes both. Id.
`
`More specifically, Viola discloses a “cartridge assembly 16 [that] is config-
`
`ured as a separate unit which is detachably connected to the distal end of elongated
`
`body portion 14. This enables the apparatus to be reloaded with a fresh cartridge
`
`for additional application of rows of fasteners.” See Viola, 5:44-54; Fischer Supp.
`
`Decl., ¶¶133-34.
`
`Viola also incorporates by reference “the contents” of U.S. Pat. App. No.
`
`08/287,455. Viola, 1:7-11. A POSITA would have understood that this statement
`
`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`18
`
`
`
`
`
`incorporates all of the ’455 application into Heinrich as if it were set out expressly
`
`rather than through incorporation. Fischer Supp. Decl., ¶134. Young is a continu-
`
`ation of the ’455 application and therefore includes the same disclosure as the ’455
`
`application.
`
`Notably, Young, which discloses an embodiment very similar to Viola’s, is
`
`assigned to the same company as Viola, and names many of the same inventors,
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`discloses that “the staple cartridge 44 can be removable so that … staple cartridge
`
`44 can be removed and replaced with a loaded staple cartridge.” Young, 8:26-32,
`
`Fig. 4; Fischer Supp. Decl., ¶134. And it was known at the time of the alleged in-
`
`vention that either solution could be used. See, e.g., Alesi, 9:20-35, Figs. 4, 14
`
`(disclosing both solutions as alternative embodiments); Fischer Supp. Decl., ¶134.
`
`If Viola is deemed not to disclose the Young subject matter incorporated by
`
`reference, it would have been obvious to combine the Viola/Heinrich loading unit
`
`with Young to arrive at the same subject matter. Fischer Supp. Decl., ¶135. A
`
`POSITA implementing the Viola/Heinrich loading unit with a replaceable staple
`
`cartridge would have been motivated to combine the Viola/Heinrich loading unit
`
`with Young because Heinrich conveniently and explicitly directs a POSITA to
`
`Young’s parent application. Id.; Viola, 1:7-11.
`
`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`19
`
`
`
`
`
`IV. CONCLUSION
`For the above reasons, Patent Owner’s Motion to Amend should be denied.
`
`
`
`Date: June 11, 2019
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`
`/John C. Phillips/
`John C. Phillips, Reg. No. 35,322
`Steven Katz, Reg. No. 43,706
`Ryan O'Connor, Reg. No. 60,254
`Fish & Richardson P.C.
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`T: 858-678-5070
`F: 877-769-7945
`
`Attorneys for Petitioner
`
`
`
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`
`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`20
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`
`
`Proceeding No. IPR2018-00934
`Attorney docket No. 11030-0049IP2
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(1) and 42.6(e)(4)(iii), the undersigned certi-
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`fies that on June 11, 2019, a complete and entire copy of this Petitioner’s Opposi-
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`tion to Patent Owner’s Motion to Amend and accompanying Exhibits were pro-
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`vided via email to the Patent Owner by serving the email correspondence ad-
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`dresses of record as follows:
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`
`
`Anish R. Desai
`Elizabeth Stotland Weiswasser
`Robert S. Magee
`Adrian Percer
`Christopher T. Marando
`Christopher M. Pepe
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`
`Email: Ethicon.IPR.Service@weil.com
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`/Diana Bradley/
`
`Diana Bradley
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(858) 678-5667
`
`
`
`
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