IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Kyle P. Moore, et al.
`In re Patent of:
`Attorney Docket No.: 11030-0049IP2
`8,998,058
`U.S. Patent No.:
`
`April 7, 2015
`Issue Date:
`
`Appl. Serial No.: 14/282,494
`
`Filing Date:
`May 20, 2014
`Title:
`DETATCHABLE MOTOR POWERED SURGICAL
`INSTRUMENT
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT
`NO. 8,998,058 PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`
`
`
`
`
`Kyle P. Moore, et al.
`In re Patent of:
`Attorney Docket No.: 11030-0049IP2
`8,998,058
`U.S. Patent No.:
`
`April 7, 2015
`Issue Date:
`
`Appl. Serial No.: 14/282,494
`
`Filing Date:
`May 20, 2014
`Title:
`DETATCHABLE MOTOR POWERED SURGICAL
`INSTRUMENT
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT
`NO. 8,998,058 PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`
`
`
`
`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`TABLE OF CONTENTS
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`I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8 .................................... 1
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ................................ 1
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2) ......................................... 1
`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ..................... 2
`D. Service Information .................................................................................. 2
`II.
`PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................... 2
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 ............................ 3
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)................................. 3
`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested ............... 3
`IV. SUMMARY OF THE ’058 PATENT ............................................................. 4
`V.
`SUMMARY OF THE PROSECUTION HISTORY ..................................... 12
`VI. CLAIM CONSTRUCTION .......................................................................... 14
`A. “Means for removably attaching said housing to the
`surgical instrument” (claim 1) ................................................................ 15
`VII. SUMMARY OF THE PRIOR ART .............................................................. 16
`A. Hooven .................................................................................................... 16
`B. Heinrich ................................................................................................... 17
`VIII. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE
`CLAIM OF THE ’058 PATENT IS UNPATENTABLE ............................. 21
`A. Ground 1: Claim 1-18 are obvious over Hooven
`in view of Heinrich ................................................................................. 21
`IX. CONCLUSION .............................................................................................. 53
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`
`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
`
`U.S. Patent No. 5,383,880 to Hooven (“Hooven”)
`
`U.S. Patent App. Pub. No. 2005/0131390 to Heinrich et al.
`(“Heinrich”)
`
`U.S. Patent No. 5,865,361 to Milliman et al. (“Milliman”)
`
`U.S. Patent No. 7,524,320 to Tierney et al. (“the ’320 patent”)
`
`U.S. Patent No. 8,196,795 to Moore et al. (“the ’795 patent”)
`
`U.S. Patent No. 8,752,749 to Moore et al. (“the ’749 patent”)
`
`U.S. Patent No. 5,779,130 to Alesi et al. (“Alesi”)
`
`[Reserved]
`
`[Reserved]
`
`U.S. Patent No. 6,783,524 to Anderson et al. (“the ’524 patent”)
`
`IS1001
`
`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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`ii
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`Intuitive Surgical, Inc. (“Petitioner”) petitions for Inter Partes Review
`
`(“IPR”) of claims 1-18 of U.S. Patent 8,998,058 (“the ’058 patent”). The ’058
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`patent relates to a “detachable motor-powered surgical instrument” in general and
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`to a “surgical cutting and stapling instrument” in particular. The claimed motor is
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`“configured to receive power from a power source such that said electrical motor
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`can only selectively receive power from said power source when said housing
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`connector is attached to the surgical instrument system.” IS1001, Claim 6.
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`Such instruments were not new at the time of the alleged priority date of the
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`’058 patent. As explained below, claims 1-18 are obvious over U.S. Patent No.
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`5,383,880 to Hooven (“Hooven”) in view of U.S. Patent App. Pub. No.
`
`2005/0131390 to Heinrich et al. (“Heinrich”). Petitioner therefore requests IPR of
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`the challenged claims.
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`I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`Intuitive Surgical, Inc. is the real party-in-interest. No other party had
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`
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`access to the Petition, and no other party had any control over, or contributed to
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`any funding of, the preparation or filing of the present Petition.
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`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`Petitioner is not aware of any disclaimers, reexamination certificates, or
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`petitions for IPR of the ’058 patent. The ’058 patent is the subject of Civil Action
`
`No. 1:17-cv-00871-LPS, filed on June 30, 2017 in the United States District Court
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`1
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`
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`for the District of Delaware. Petitioner was served with the complaint in that
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`action on July 12, 2017. Concurrently with this petition, Petitioner filed IPR
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`petitions for U.S. Pat. Nos. 8,991,677 and 9,084,601, which are related to the ’058
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`patent.
`
`C.
` Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Petitioner provides the following designation of counsel.
`
`LEAD COUNSEL
`John C. Phillips, Reg. No. 35,322
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 858-678-5070 / Fax 877-769-7945
`
`BACK-UP COUNSEL
`Steven R. Katz, Reg. No. 43,706
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 617-542-5070
`
`Ryan P. O’Connor, Reg. No. 60,254
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 858-678-5070
`
`
`D.
`Service Information
`Please address all correspondence and service to the address listed above.
`
`Petitioner consents to electronic service by email at IPR11030-0049IP2@fr.com
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`(referencing No. 11030-0049IP2 and cc’ing PTABInbound@fr.com,
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`phillips@fr.com, katz@fr.com, and oconnor@fr.com).
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`II.
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`PAYMENT OF FEES – 37 C.F.R. § 42.103
`Petitioner authorizes the Office to charge Deposit Account No. 06-1050 for
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`the petition fee set in 37 C.F.R. § 42.15(a) and for any other required fees.
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`2
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner certifies that the ’058 patent is available for IPR, and Petitioner is
`
`not barred or estopped from requesting IPR.
`
`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`Petitioner requests IPR of claims 1-18 of the ’058 patent on the following
`
`ground. Dr. Gregory S. Fischer’s declaration (IS1003) is included in support.
`
`Ground
`Ground 1
`
`Claims
`1-18
`
`Basis for Rejection
`Obvious under 35 U.S.C. § 103 over
`Hooven (IS1004) in view of Heinrich
`(IS1005).
`
`
`The ’058 patent issued from U.S. App. No. 14/282,494, filed on May 20,
`
`2014, which is a continuation of U.S. App. No. 13/832,522, filed on Mar. 15, 2013,
`
`now U.S. Pat. No. 9,084,601, which is a continuation of U.S. App. No. 13/118,210,
`
`filed on May 27, 2011, now U.S. Pat. No. 8,752,749, which is a continuation-in-
`
`part of U.S. App. No. 12/856,099, filed on Aug. 13, 2010, now U.S. Pat. No.
`
`8,196,795, which is a continuation of U.S. App. No. 12/031,628, filed on Feb. 14,
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`2008, now U.S. Pat. No. 7,793,812. Accordingly, the earliest possible date to
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`which the ’058 patent could claim priority (hereinafter the “earliest effective filing
`
`date”) is Feb. 14, 2008.
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`Petitioner does not concede that the challenged claims of the ’058 patent are
`
`entitled to this priority date, but has elected not to argue the issue in the present
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`3
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`Petition because all prior art references identified in the Ground presented below
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`predate the earliest possible priority date for the ’058 patent. However, Petitioner
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`reserves the right to present such an argument in this proceeding or other
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`proceedings involving the ’058 patent.
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`Hooven (IS1004) published on Jan. 24, 1995, which is more than one year
`
`before the earliest effective filing date, and thus qualifies as prior art under 35
`
`U.S.C. § 102(b). Hooven was made of record during prosecution of the ’058
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`patent, but never was discussed by the examiner or the applicant.1
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`Heinrich (IS1005) published on June 16, 2005, which is more than one year
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`before the earliest effective filing date, and thus qualifies as prior art under 35
`
`U.S.C. § 102(b). Heinrich was made of record during prosecution of the ’058
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`patent, but it never was discussed by the examiner or the applicant.
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`IV. SUMMARY OF THE ’058 PATENT
`The ’058 patent describes a detachable motor-powered stapling system, such
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`as a surgical stapler, that is removably attachable to a surgical instrument system,
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`such as a surgical robot or hand-held actuator, and permits the motor residing in
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`the stapling system to receive power only when the stapling system’s housing is
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`operably attached to the surgical instrument system. IS1001, Abstract.
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`
`1 Applicants cited more than 4000 references during prosecution of the ’058 patent.
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`4
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`In a first embodiment, “a disposable loading unit 16 [(i.e., stapling system)]
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`is coupled to a conventional surgical cutting and stapling apparatus 10.” IS1001,
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`10:21-25, Fig. 1.
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`As explained in more detail below, disposable loading unit 16 includes a
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`mechanism that separates its motor from its power source (i.e., battery) when the
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`disposable loading unit 16 is detached from the handle assembly 12 (i.e., surgical
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`instrument system) of the surgical cutting and stapling apparatus 10. IS1001,
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`11:29-58, Figs. 2-12.
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`Figs. 13-14 show a second embodiment2 in which a surgical tool 1200 (i.e.,
`
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`2 Applicants added this robotic embodiment to the specification for the first time
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`on May 27, 2011. Thus, May 27, 2011 may be the earliest priority date for one or
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`more claims of the ’058 patent.
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`5
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`stapling system) is coupled to a robotic system 1000 (i.e., surgical instrument
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`system) comprising a robotic arm cart 1100 and a controller 1001. IS1001, 15:25-
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`30, 15:45-47, Figs. 13-14. The motor 3011 to drive the tool 1200, and its power
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`source (i.e., battery 3022), can reside within a detachable tool mounting portion
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`3010. See, e.g., IS1001, 38:17-39:50, Fig. 52. In this embodiment, an on-off
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`solenoid powered switch 3024 electrically isolates the motor from its power source
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`when the tool mounting portion 3010 is detached from the robot 1100. Id. Thus,
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`power can be supplied to the motor only when the tool mounting portion 3010 is
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`attached to the robotic system 1000. Id.; IS1003, ¶ 54.
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`“Examples of [robotic system 1000] are disclosed in U.S. Pat. No. 7,524,320
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`which [is] incorporated by reference” into the ’058 patent. IS1001, 15:30-32.
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`Indeed, Figures 13, 14, and 16 all appear to be taken from the prior art ’320 patent.
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`Compare IS1001, Figs. 13, 14, 16 with IS1007, Figs. 2, 3A, 8B.
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`6
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`With regard to the first embodiment shown in Figs. 1 and 2, “the disposable
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`loading unit 16 may generally comprise a tool assembly 17 for performing surgical
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`procedures such as cutting tissue and applying staples on each side of the cut. The
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`tool assembly 17 may include a cartridge assembly 18 that includes a staple
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`cartridge 220 that is supported in a carrier 216. An anvil assembly 20 may be
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`pivotally coupled to the carrier 216 in a known manner for selective pivotal travel
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`between open and closed positions. . . . An actuation sled 234 is supported within
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`the tool assembly 17 and is configured to drive [] pushers and staples in the staple
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`cartridge 220 in a direction toward the anvil assembly 20 as the actuation sled 234
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`is driven from the proximal end of the tool assembly 17 to the distal end 220.”
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`IS1001, 10:45-63, Fig. 2.
`
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`“The disposable loading unit 16 may further include an axial drive assembly
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`212 that comprises a drive beam 266. . . . The distal end of drive beam 266 may
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`7
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`include a vertical support strut 271 which supports a knife blade 280 and an
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`abutment surface 283 which engages the central portion of actuation sled 234
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`during stapling procedure.” IS1001, 10:64-11:5, Fig. 2.
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`The housing 200 of disposable loading unit 16 may further include: (1) “a
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`switch portion 520 that movably houses a battery 526 therein”; (2) a motor 562; (3)
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`a drive screw 600; and (4) a knife nut 610. IS1001, 11:29-12:51, Fig. 5.
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`8
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`Battery 526 provides power to the motor 562, the operation of which causes an
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`output shaft 566 to rotate. Id. Rotation of output shaft 566 effects “rotation of the
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`drive screw 600 within the drive nut 610 [to] drive the drive beam 266 in the distal
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`direction ‘DD’ or in the proximal direction ‘PD’ depending upon the direction of
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`rotation of the drive screw 600.” Id.
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`When the disposable loading unit (“DLU”) 16 is detached from
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`surgical/stapling apparatus 10, battery 526 is disconnected from the motor 562
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`(i.e., a biasing/spring member 550 is not providing connectivity between battery
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`526 and motor 562) resulting in no power being supplied to the motor 562. Id.
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`Battery 526 makes contact with contacts 540, 542, or 544 (thereby supplying
`
`power to the motor 562) when the DLU 16 is connected to the surgical apparatus
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`10. Id. Surgical apparatus 10 includes a control rod 52 that inserts into a control
`
`rod socket 532 of the housing 200 of DLU 16 to cause the battery contacts 528,
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`530 to make a connection with contacts 540, 542, or 544. Id. Conversely, when
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`the control rod 52 is not inserted into the control rod socket 532 (i.e., when the
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`DLU 16 is detached from the surgical apparatus 10), there is no longer any contact
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`between battery 526 and motor 562. Id. This breaks the electrical connection
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`between the battery 526 and the contacts 540, 542, 544. Id. Consequently, the
`
`battery 526 supplies power to motor 562 only when the housing 200 of DLU 16 is
`
`attached to the surgical apparatus 10. Id. The ’058 patent states that the purpose
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`9
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`of this mechanism is to “prevent the battery 526 from being drained during non-
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`use.” Id.
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`In the second embodiment, the ’058 patent describes a tool mounting portion
`
`3010 that sits in between the surgical tool 3000 and the robotic system 1000. See,
`
`e.g., IS1001, 38:17-39:43, Fig. 52.
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`10
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`The surgical tool 3000 is detachable from the tool mounting portion 3010, which in
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`turn is detachable from the robotic system 1000. Id. The tool mounting portion
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`3010 has a control circuit 3020, which includes “a power supply in the form of a
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`battery 3022 that is coupled to an on-off firing solenoid powered switch 3024.” Id.
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`“Thus, when the controller 1001 of the robotic system 1000 supplies an appropriate
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`control signal, switch 3024 will permit battery 3022 to supply power to the double
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`pole switch 3028… to supply power to the motor 3011.” Id. Because the switch
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`3024 will change from an open (off) state to a closed (on) state only upon receiving
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`a control signal from the robotic system 1000, power can be supplied to the motor
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`3011 only when an electrical connection is made between tool mounting portion
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`3010 and robotic system 1000 (e.g., the housing of tool mounting portion 3010 is
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`physically attached to robotic system 1000). Id.; IS1003, ¶ 52.
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`“In alternative embodiments, [however,] the power supply may comprise
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`alternating current ‘AC’ that is supplied to the motors by the robotic system 1000.
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`That is, the AC power would be supplied from the system powering the robotic
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`system 1000 through the tool holder and adapter. In still other embodiments, a
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`power cord or tether may be attached to the tool mounting portion 3300 to supply
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`the requisite power from a separate source of alternating or direct current.”
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`IS1001, 44:1-12; see also 52:33-38 (“In one form or embodiment, the control
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`circuit 3910 includes a power supply in the form of a battery 3912. . . . In other
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`11
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`embodiments, however, the power supply may comprise a source of alternating
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`current.”). In this latter embodiment, the electrical connection between the motor
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`and the robotic system supplies power to the motor and this power is cut off when
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`the housing of tool-mounting portion 3010 is detached from the robotic system
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`1000. IS1003, ¶ 53.
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`V.
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`SUMMARY OF THE PROSECUTION HISTORY
`The chain of applications to which the ’058 patent claims priority is
`
`provided above. See Section III.B, supra. Notably, the ’210 continuation-in-part
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`priority application added descriptions of various robotic systems that were not
`
`disclosed in the earlier priority applications. Compare IS1008 (’795 patent) with
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`IS1009 (’749 patent) (adding the text at 3:8-4:5, 15:18-80:2, and Figs. 13-130 to
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`the ’795 patent). During prosecution of the ’058 patent’s priority applications, the
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`USPTO rejected one or more of applicant’s original claims as anticipated by Alesi
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`or obvious over Alesi in view of other references. IS1002, 2-6, 21-22, 38. Like
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`the ’058 patent, Alesi discloses a self-contained powered surgical stapler.
`
`IS1010, Fig. 1.
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`12
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`In response to these rejections, applicant amended all of the pending claims
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`to require a battery/power source in the housing of the disposable loading unit that
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`is movable from a disconnected position to a connected position when attached to a
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`control rod/member of a surgical instrument. IS1002, 10-15, 26-31.
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`The claims presented in the application that issued as the ’058 patent,
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`however, included no such limitations. IS1002, 74-77. As a result, they are
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`broader than the claims examined during prosecution of the ’058 patent’s priority
`
`applications. For example, instead of the specific movable battery configuration
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`claimed in the earlier priority applications, the ’058 patent’s claims require only
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`“an electric motor… configured to receive power from a power source such that
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`[the] electrical motor can only selectively receive power from [the] power source
`
`when [the] housing connector is attached to the surgical instrument system.”
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`IS1001, Claim 6; see also Claims 11 and 15 (same). There is no requirement that
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`the surgical instrument include its own power source at all, much less one that is
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`movable from a disconnected position to a connected position. Id. The examiner,
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`however, appears to have incorrectly assumed that the challenged claims had the
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`same or narrower scope as the claims allowed in the parent applications. Thus,
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`provisional non-statutory double patenting rejections in view of claims in pending
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`applications co-owned by applicant were the only rejections of the ’058 patent’s
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`claims during prosecution.
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`13
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`The broader scope of the ’058 patent’s claims encompasses known devices.
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`Indeed, numerous references disclose the purportedly missing feature—i.e., an
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`electric motor configured to receive power from a power source only when the
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`stapling system’s housing is attached to the surgical instrument system. Hooven
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`and Heinrich, for example, each discloses an electric motor housed within a
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`disposable loading unit that is removably connected to a surgical instrument
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`system wherein the surgical instrument system supplies power to the motor.
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`IS1004; IS1005; IS1003, ¶¶ 78, 83. Thus, these motors are configured to receive
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`power from the surgical instrument system (i.e., the power source) only when the
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`disposable loading unit’s housing is attached to the surgical instrument system, as
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`required by the ’058 patent’s claims. IS1003, ¶¶ 78, 83.
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`VI. CLAIM CONSTRUCTION
`For the purposes of this IPR only, Petitioner submits that the terms of the
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`’058 patent are to be given their broadest reasonable interpretation as understood
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`by one of ordinary skill in the art at the time in view of the specification (“BRI”).3
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`3 Petitioner acknowledges that the Office has proposed to change from the BRI
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`standard to the standard applied in District Courts. See 83 Fed. Reg. 21221
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`(proposed May 9, 2018). Petitioner submits that the prior art discussed herein
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`invalidates the challenged claims under either standard. If the Office changes the
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`14
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`37 C.F.R. § 42.100(b). Also, for purposes of this IPR only, Petitioner submits the
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`following specific constructions for certain terms.
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`A.
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`“Means for removably attaching said housing to the surgical
`instrument” (claim 1)
`This claim element includes the words “means” and therefore presumptively
`
`invokes 35 U.S.C. § 112, ¶ 6. The claimed function performed by the “means” is
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`“removably attaching said housing to the surgical instrument,” which requires no
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`further construction. IS1001, Claim 1. The corresponding structures in the ’058
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`patent that perform this function include engagement nubs 254. IS1001, 11:23-28,
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`Fig. 2; IS1003, ¶¶ 62-65.
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`Fig. 2 of the ’058 patent shows “engagement nubs 254 [on disposable
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`loading unit 16] for releasably engaging elongated body 14 of a surgical stapling
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`apparatus [10].” IS1001, 11:23-28, Fig. 2.
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`rule after the filing of the Petition and applies the new standard to this proceeding,
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`then due process requires the Office afford Petitioner an opportunity to provide
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`additional argument and evidence on that issue.
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`15
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
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`VII. SUMMARY OF THE PRIOR ART
`A. Hooven
`Hooven discloses a controller 31 removably connected to a disposable
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`loading unit (i.e., endoscopic surgical cutting and stapling instrument 30) that is
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`capable of applying lines of staples to tissue while cutting the tissue between those
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`staple lines. E.g., IS1004, Figs. 1, 3, 6; IS1003, ¶¶ 82-83.
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`As shown below, Hooven’s surgical cutting and stapling instrument 30
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`includes a closure nut 77, a firing nut 86, a knife 82, and a wedge 83 that are all
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`driven by a motor-powered threaded rod 71. Id. The motor 45 residing in the
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`instrument 30 is disconnected from its power source, which resides in controller
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`31, when the instrument 30 is not attached to the controller 31, and is connected to
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`the power source when the instrument 30 is attached to the controller 31. Id.;
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`IS1004, 4:24-26. In other words, the motor can receive power only when the
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`surgical stapler is connected to the surgical instrument system that controls the
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`stapler. Id.
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`B. Heinrich
`Heinrich discloses an actuation assembly 612 and a robotic arm 616
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`removably attached to a motor powered disposable loading unit 618 that can be a
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`surgical stapler. See, e.g., IS1005, ¶¶ 132, 140, Figs. 7, 9. “Disposable loading
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`unit 618 . . . includes a head portion 640 for housing an electro-mechanical
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`assembly 619 (see Fig. 8) therein for operating surgical instrument 620 and an
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`attachment platform 642 for releasably attaching disposable loading unit 618 to
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`robot 616 via mounting flange 636.” IS1005, ¶ 134; see also claim 37.
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`The motor (i.e., electro-mechanical assembly 619) residing in the disposable
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`loading unit 618 is disconnected from its power source in the robotic surgical
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`system 600 when the disposable loading unit 618 is not attached to the robotic
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`surgical system 600, and is connected to the power source when the disposable
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`loading unit 618 is attached to the robotic surgical system 600. See, e.g., IS1005, ¶
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`134, Fig. 8; IS1003, ¶ 78. Thus, the motor can receive power only when the
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`disposable loading unit is connected to the robotic surgical system.
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`Like the ’058 patent, Heinrich incorporates by reference the entire contents
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`of Milliman for a more detailed explanation of the operation of the surgical stapler.
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`IS1005, ¶ 99; IS1003, ¶ 76. Specifically, Milliman discloses an endoscopic surgi-
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`cal cutting and stapling apparatus 10 comprising disposable loading units 16 that
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`are capable of applying lines of staples to tissue while cutting the tissue between
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`those staple lines. E.g., IS1006, Fig. 1.
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`Milliman also discloses an axial drive assembly 212 that includes a drive
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`beam 266 that supports a knife blade 280, a camming pin 286, and an abutment
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`surface 283 that engages the central portion of a sled during a stapling procedure.
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`IS1006, Figs. 32-34, 49.
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
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`And Milliman discloses the internal structure of the surgical stapler, includ-
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`ing its carrier 216 and removable staple cartridge 220. IS1006, Fig. 21.
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`VIII. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE
`CLAIM OF THE ’058 PATENT IS UNPATENTABLE
`For the reasons explained below, claims 1-18 of the ’058 patent are invalid.
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`A. Ground 1: Claim 1-18 are obvious over Hooven in view of
`Heinrich
`Because claims 6-18 have been asserted in litigation, we begin with those
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`claims.
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`Claims 6-18
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`[6.1] A stapling system configured to be operably engaged with a surgical
`instrument system, said stapling system comprising
`If this preamble is deemed to be a limitation, Hooven discloses it. IS1003,
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`¶¶ 205-12.
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`“Stapling system”
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`Hooven discloses a stapling system (i.e., endoscopic stapling and cutting
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`instrument 30). Id.; IS1004, 4:15-17; see also IS1004, 2:58-63 (“[E]ndoscopic
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`instrument [30] has a head portion for carrying out a step in an endoscopic
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`procedure. The step may be . . . stapling, cutting, . . . etc. or combinations of these
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`steps.”), 4:45-53 (“In the embodiment depicted in FIGS. 2 through 9, the head
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`portion is a linear stapler and cutter.”), Figs. 1-9.
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`IPR of U.S. Patent No. 8,998,058
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`“Configured to be operably engaged with a surgical instrument system”
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`As shown above, Hooven’s stapling system (i.e., endoscopic stapling and
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`cutting instrument 30) is configured to be operably engaged with a surgical
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`instrument system (i.e., the combination of controller 31 and video display monitor
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`32) by a cable. IS1003, ¶ 207; IS1004, 4:13-17 (“an endoscopic stapling system
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`[30] is interconnected with a controller 31 and a video display monitor 32”), Fig. 1;
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`see also 8:57-59 (“The endoscopic instrument [200] is . . . connected to the
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`controller [203] by a cable 205.”), 9:1-3 (“All sensors, switches, and motors [204]
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`[in instrument 200] are connected to the controller [203] via the interface cable
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`205.”), Fig. 18.
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`If Hooven is deemed not to disclose a “surgical instrument system,” then it
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`would have been obvious in view of Heinrich to combine Hooven’s stapling
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`system (i.e., endoscopic stapling and cutting instrument 30) with a surgical
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`instrument system. IS1003, ¶¶ 208-12. As shown below, Heinrich discloses a
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`surgical instrument system (i.e., the combination of actuation assembly 612,
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`monitor 614, and robot 616) that is very similar to a surgical instrument system
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`disclosed in the ’058 patent.
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`When, as here, “there are a finite number of identified, predictable solutions,
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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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`In this case, Hooven describes one predictable solution for manipulating the
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`surgical instrument—i.e., partially by hand and partially based on signals received
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`from the control unit 31. And Heinrich describes another predictable solution—
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`i.e., using a robotic arm. IS1005, ¶ 132 (“[L]oading unit 618 [is] releasably
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`attached to robot 616.”), Fig. 7.
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`A POSITA would have been motivated to configure Hooven’s stapling
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`system for operable attachment to Heinrich’s robotic surgical instrument system
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`for several reasons. For example, as recognized by the ’058 patent, “robotic (or
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`‘telesurgical’) systems . . . increase surgical dexterity [and] permit a surgeon to
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`operate on a patient in an intuitive manner.” IS1001, 14:60-63; see also 14:63-
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`15:7 (incorporating U.S. Pat. No. 6,783,524 by reference); IS1013 (’524 patent),
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`2:37-55 (describing advantages of robotic systems over manual systems and noting
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`that: “The surgeon can [also] typically perform the surgical procedure at [a]
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`location remote from the patient”).
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`Moreover, such a modification of Hooven’s endoscopic stapling and cutting
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`instrument 30 would have been well within a POSITA’s abilities. Indeed, it would
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`have been merely the application of a known technique (e.g., using a robotic arm)
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`to a known system (e.g., Hooven’s disposable loading unit) in the same field of
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`endeavor (i.e., remote controlled surgical staplers). IS1003, ¶ 211; KSR, 550 U.S.
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`at 417 (“[W]hen a patent simply arranges old elements with each performing the
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`same function it had been known to perform and yields no more than one would
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`expect from such an arrangement, the combination is obvious.”) (internal quotation
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`marks omitted). In combination, each element (i.e., Heinrich’s robotic system and
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`Hooven’s disposable loading unit) merely performs the same function as it does
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`separately. IS1003, ¶ 211. And the combination of Hooven and Heinrich
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`proposed here would have yielded predictable results without significantly altering
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`or hindering the functions performed by Hooven’s device. Id. Not surprisingly,
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`the ’058 patent explicitly concedes that a POSITA would have known how to use a
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`“wide variety of alternative robotic structures.” IS1001, 16:40-47.
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`Finally, it would have been an obvious design choice. IS1003, ¶ 212. As
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`recognized by the ’058 patent, “[m]any [robotic] systems are disclosed in [the prior
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`art].” IS1001, 14:63-15:21; see also 15:47-53, 16:9-16, 16:40-47. And, as shown
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`by Heinrich, making a manual surgical stapler compatible with a robotic system
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`was desirable. IS1003, ¶ 212. Accordingly, a POSITA would have recognized
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`that a robotic system, like Heinrich’s, is an effective and efficient mechanism for
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`manipulating Hooven’s endoscopic stapling and cutting instrument 30. Id.
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`[6.2] a staple cartridge carrier
`Hooven discloses this limitation. IS1003, ¶ 213. Hooven discloses a staple
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`holding portion and a staple cartridge holding member 161, which are staple
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`cartridge carriers. Id.; IS1004, 6:3-9 (“Mounted in the staple holding portion of the
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`instrument is a removable staple cartridge 80. The cartridge holds four rows of
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`Attorney Docket No. 11030-0049IP2
`IPR of U.S. Patent No. 8,998,058
`staples 81. The rows are parallel and in adjacent rows
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