`
`
`Kyle P. Moore, et al.
`In re Patent of:
`Attorney Docket No.: 11030-0049IP3
`8,991,677
`U.S. Patent No.:
`
`March 31, 2015
`Issue Date:
`
`Appl. Serial No.: 14/283,729
`
`Filing Date:
`May 21, 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. 8,991,677 PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`
`
`
`
`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`TABLE OF CONTENTS
`
`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) ......................................... 2
`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ..................... 2
`D. Service Information .................................................................................. 2
`PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................... 3
`II.
`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 ’677 PATENT ............................................................. 5
`V.
`SUMMARY OF THE PROSECUTION HISTORY ..................................... 13
`VI. CLAIM CONSTRUCTION .......................................................................... 16
`A. “Means for removably attaching said housing to the
`surgical instrument” (claims 1, 16) ......................................................... 16
`B. “Drive means for converting the rotational motion produced
`by said electric motor to translational motion to eject said
`staples from said staple cartridge body” (claims 11, 18) ........................ 17
`VII. SUMMARY OF HOOVEN AND HEINRICH ............................................. 22
`A. Hooven .................................................................................................... 22
`B. Heinrich ................................................................................................... 24
`VIII. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE
`CLAIM OF THE ’677 PATENT IS UNPATENTABLE ............................. 27
`A. Ground 1: Claims 1-18 are obvious over Hooven
`in view of Heinrich ................................................................................. 27
`B. Ground 2: Claims 1-5 and 16 are obvious over Hooven
`in view of Heinrich and further in view of Milliman ............................. 69
`C. Ground 3: Claims 1-5 and 16 are obvious over Hooven
`in view of Heinrich and further in view of Alesi .................................... 70
`IX. CONCLUSION .............................................................................................. 72
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`i
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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`EXHIBITS
`
`U.S. Patent No. 8,991,677 to Moore et al. (“the ’677 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
`
`IS1003
`
`IS1004
`
`IS1005
`
`IS1006
`
`IS1007
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`IS1008
`
`IS1009
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`IS1010
`
`IS1011
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`IS1012
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`IS1013
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`
`
`
`
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`
`ii
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`Intuitive Surgical, Inc. (“Petitioner”) petitions for Inter Partes Review
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`(“IPR”) of claims 1-18 of U.S. Patent No. 8,991,677 (“the ’677 patent”). The ’677
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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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`operably disconnected from a power source when the housing of the stapling sub-
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`system is not attached to the surgical instrument system, and operably connected to
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`the power source when the housing of the stapling sub-system is attached to the
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`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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`’677 patent. As explained below, claims 1-18 are obvious over U.S. Patent No.
`
`5,383,880 to Hooven (“Hooven”) in view of U.S. Patent App. Pub. No.
`
`2005/0131390 to Heinrich et al. (“Heinrich”), U.S. Patent No. 5,779,130 to Alesi et
`
`al. (“Alesi”), and/or U.S. Patent No. 5,865,361 to Milliman et al. (“Milliman”).
`
`Petitioner therefore requests IPR of the challenged claims on Grounds 1-3 below.
`
`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
`
`any funding of, the preparation or filing of the present Petition.
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`1
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`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 ’677 patent. The ’677 patent is the subject of Civil Action
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`No. 1:17-cv-00871-LPS, filed on June 30, 2017 in the United States District Court
`
`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. 8,998,058 and 9,084,601, which are related to the ’677
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`patent.
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`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 IPR11030-0049IP3@fr.com
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`(referencing No. 11030-0049IP3 and cc’ing PTABInbound@fr.com,
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`phillips@fr.com, katz@fr.com, and oconnor@fr.com).
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`2
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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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.
`
`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 ’677 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 ’677 patent on the following
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`grounds. Dr. Gregory S. Fischer’s declaration (IS1003) is included in support.
`
`Ground
`Ground 1
`
`Claims
`1-18
`
`Ground 2
`
`1-5, 16
`
`Ground 3
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`1-5, 16
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`Basis for Rejection
`Obvious under 35 U.S.C. § 103 over
`Hooven (IS1004) in view of Heinrich
`(IS1005)
`Obvious under 35 U.S.C. § 103 over
`Hooven (IS1004) in view of Heinrich
`(IS1005) and further in view of
`Milliman (IS1006)
`Obvious under 35 U.S.C. § 103 over
`Hooven (IS1004) in view of Heinrich
`(IS1005) and further in view of Alesi
`(IS1010)
`
`
`The ’677 patent issued from U.S. App. No. 14/283,729, filed on May 21,
`
`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,
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`3
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`filed on May 27, 2011, now U.S. Pat. No. 8,752,749, which is a continuation-in-
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`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 ’677 patent could claim priority (hereinafter the “earliest effective filing
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`date”) is Feb. 14, 2008.
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`Petitioner does not concede that the challenged claims of the ’677 patent are
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`entitled to this priority date, but has elected not to argue the issue in the present
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`Petition because all prior art references identified in the Grounds presented below
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`pre-date the earliest possible priority date for the ’677 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 ’677 patent.
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`Hooven (IS1004) issued 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 ’677
`
`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
`
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`1 Applicants cited more than 4000 references during prosecution of the ’677 patent.
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`4
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`U.S.C. § 102(b). Heinrich was made of record during prosecution of the ’677
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`patent, but never was discussed by the examiner or the applicant.
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`Milliman (IS1006) issued on Feb. 2, 1999, 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). Milliman was made of record during prosecution of the ’677
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`patent. In fact, it is incorporated by reference into the specification of the ’677
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`patent. However, it never was discussed by the examiner.
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`Alesi (IS1010) issued on July 14, 1998, which is more than one year before
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`the earliest effective filing date, and thus qualifies as prior art under 35 U.S.C. §
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`102(b). Alesi was cited by the examiner during prosecution of the ’677 patent’s
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`priority applications.
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`IV. SUMMARY OF THE ’677 PATENT
`The ’677 patent describes a detachable motor-powered stapling sub-system,
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`such as a surgical stapler, that is removably attachable to a surgical instrument
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`system, such as a surgical robot or hand-held actuator. The motor residing in the
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`stapling sub-system is disconnected from its power source when the stapling sub-
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`system’s housing is not attached to the surgical instrument system, and is
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`connected to the power source when the housing is attached to the surgical
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`instrument system. IS1001, Abstract, Claim 6. In other words, the motor can
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`receive power only when the surgical stapler is connected to the surgical
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`5
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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`instrument system that controls the stapler.
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`In a first embodiment, “a disposable loading unit 16 [(i.e., stapling sub-
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`system)] is coupled to a conventional surgical cutting and stapling apparatus 10.”
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`IS1001, 10:54-58, Fig. 1.
`
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`As explained below, disposable loading unit 16 includes a mechanism that
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`separates its motor from its power source (i.e., battery) when the disposable
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`loading unit 16 is detached from the handle assembly 12 of the surgical cutting and
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`stapling apparatus 10. IS1001, 11:62-12:24, Figs. 2-12. “The construction and
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`general operation of a cutting and stapling apparatus 10 is described in [Milliman],
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`the disclosure of which [is] incorporated by reference” into the ’677 patent.
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`IS1001, 10:58-61; compare IS1001, Fig. 1 with IS1006, Fig. 1.
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`Figs. 13 and 14 show a second embodiment in which the surgical tool 1200
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`(i.e., stapling sub-system) is coupled to a robotic system 1000 (i.e., surgical
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`6
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`instrument system) comprising a robotic arm cart 1100 and a controller 1001.2
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`IS1001, 15:58-63, 16:11-13, Figs. 13-14. The motor 3011 to drive the tool 1200,
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`and its power source (i.e., battery 3022), reside within a detachable tool mounting
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`portion 3010. IS1001, 38:46-40:5, Fig. 52. As explained below, in this example,
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`an on-off solenoid powered switch 3024, which is controlled by a signal from the
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`robotic system 1000, electrically isolates the motor from its power source when the
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`tool-mounting portion 3010 is detached from the robot 1100. Id. Thus, power can
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`be supplied to the motor only when the tool mounting portion 3010 is attached to
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`the robotic arm cart 1100 and controller 1001. Id.; IS1003, ¶ 54.
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`2 Applicants added this robotic embodiment to the specification for the first time
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`
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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 ’677 patent.
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`7
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`“Examples of [robotic system 1000] are disclosed in U.S. Pat. No. 7,524,320, [one
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`of Petitioner’s prior art patents,] which [is] incorporated by reference” into the
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`’677 patent. IS1001, 15:60-65. Indeed, Figures 13, 14, and 16 all appear to be
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`taken from Petitioner’s prior art ’320 patent. Compare IS1001, Figs. 13, 14, 16
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`with IS1007, Figs. 2, 3A, 8B.
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`With regard to the first embodiment shown in Figs. 1 and 2 of the ’677
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`patent, “the disposable loading unit 16 may generally comprise a tool assembly 17
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`for performing surgical procedures such as cutting tissue and applying staples on
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`each side of the cut. The tool assembly 17 may include a cartridge assembly 18
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`that includes a staple cartridge 220 that is supported in a carrier 216. An anvil
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`assembly 20 may be pivotally coupled to the carrier 216 in a known manner for
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`selective pivotal travel between open and closed positions. . . . An actuation sled
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`234 is supported within the tool assembly 17 and is configured to drive . . . pushers
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`and staples in the staple cartridge 220 in a direction toward the anvil assembly 20
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`as the actuation sled 234 is driven from the proximal end of the tool assembly 17 to
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`the distal end 220.” IS1001, 11:11-29, Fig. 2.
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`8
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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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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`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 a stapling procedure.” IS1001, 11:30-38, Fig. 2.
`
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`The housing 200 of disposable loading unit 16 (“DLU 16”) may further
`
`include: (1) a switch portion 520 that movably houses a battery 526 therein; (2) a
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`motor 562; (3) a drive screw 600; and (4) a drive nut 610. IS1001, 11:62-12:48,
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`13:3-17, Fig. 5.
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`9
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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`
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`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 DLU 16 is detached from surgical/stapling apparatus 10, battery 526
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`is disconnected from the motor 562 (i.e., a biasing/spring member 550 is not
`
`providing connectivity between battery 526 and motor 562) resulting in no power
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`being supplied to the motor 562. Id. Battery 526 makes contact with contacts 540,
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`542, or 544 (thereby supplying power to the motor 562) when the DLU 16 is
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`connected to the surgical apparatus 10. Id. Surgical apparatus 10 includes a
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`10
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`control rod 52 that inserts into a control rod socket 532 of the housing 200 of DLU
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`16 to cause the battery contacts 528, 530 to make a connection with contacts 540,
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`542, or 544. Id. Conversely, when the control rod 52 is not inserted into the
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`control rod socket 532 (i.e., when the disposable loading unit 16 is detached from
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`the surgical apparatus 10), there is no longer any contact between battery 526 and
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`motor 562. Id. This breaks the electrical connection between the battery 526 and
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`the contacts 540, 542, 544. Id. Consequently, the battery 526 supplies power to
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`motor 562 only when the housing 200 of DLU 16 is attached to the surgical
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`apparatus 10. Id. The ’677 patent states that the purpose of this mechanism is to
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`“prevent the battery 526 from being drained during non-use.” Id.
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`In the second embodiment, the ’677 patent describes a tool mounting portion
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`3010 that sits in between the surgical tool 3000 and the robotic system 1000. See,
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`e.g., IS1001, 38:46-40:5, Fig. 52.
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`Attorney Docket No. 11030-0049IP3
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`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
`
`battery 3022 that is coupled to an on-off solenoid powered switch 3024.” IS1001,
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`39:37-55. “Thus, when the controller 1001 of the robotic system 1000 supplies an
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`appropriate control signal, switch 3024 will permit battery 3022 to supply power to
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`the double pole switch 3028 . . . to supply power to the motor 3011.” Id. Because
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`the switch 3024 will change from an open (off) state to a closed (on) state only
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`upon receiving a control signal from the robotic system 1000, power can be
`
`supplied to the motor 3011 only when an electrical connection is made between
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`tool mounting portion 3010 and robotic system 1000 (e.g., the housing of tool
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`mounting portion 3010 is physically attached to robotic system 1000). Id.; IS1003,
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`¶¶ 47, 52.
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`12
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`“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, 44:29-40; see also 52:61-66 (“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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`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 ’677 patent claims priority is
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`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
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`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 ’677 patent’s priority applications, the
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`13
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`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 ’677 patent, Alesi discloses a self-contained powered surgical stapler.
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`IS1010, Fig. 1.
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`
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`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 ’677 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 ’677 patent’s priority
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`applications. For example, instead of the specific movable battery configuration
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`claimed in the earlier priority applications, the ’677 patent’s claims require only
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`“an electric motor . . . [that] is operably disconnected from a power source when
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`[the] housing [of the stapling sub-system] is not attached to the surgical instrument
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`system, and . . . is operably connected to the power source when [the] housing is
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`14
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`attached to the surgical instrument system.” IS1001, Claim 6. There is no
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`requirement that the surgical instrument include its own power source at all, much
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`less one that is movable from a disconnected position to a connected position. Id.
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`The examiner, however, appears to have incorrectly assumed that the challenged
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`claims had the same or narrower scope as the claims allowed in the parent
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`applications. Thus, provisional non-statutory double patenting rejections in view
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`of claims in pending applications co-owned by applicant were the only rejections
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`of the ’677 patent’s claims during prosecution.
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`This broader scope of the ’677 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 that is operably disconnected from a power source when the housing
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`of the stapling sub-system is not attached to the surgical instrument system, and is
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`operably connected to the power source when the housing is attached to the
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`surgical instrument system. Hooven and Heinrich, for example, disclose an
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`electric motor in the housing of a stapling sub-system that is removably connected
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`to a surgical instrument system wherein the surgical instrument system supplies
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`power to the motor. IS1004; IS1005; IS1003, ¶¶ 78, 83. Thus, the motor is
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`operably disconnected from a power source when the housing of the stapling sub-
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`system is not attached to the surgical instrument system, and is operably connected
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`to the power source when the housing is attached to the surgical instrument system,
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`15
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`as required by the ’677 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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`’677 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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`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” (claims 1, 16)
`This claim element includes the words “means” and therefore presumptively
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`invokes 35 U.S.C. § 112, ¶ 6 (“112/6”). The claimed function performed by the
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`“means” is “removably attaching said housing to the surgical instrument.” IS1001,
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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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`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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`16
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`Claim 1. The corresponding structures in the ’677 patent that perform this function
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`include engagement nubs 254. IS1001, 11:56-59, Fig. 2; IS1003, ¶¶ 62-65.
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`Fig. 2 of the ’677 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, 11:56-59.
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`B.
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`“Drive means for converting the rotational motion produced by
`said electric motor to translational motion to eject said staples
`from said staple cartridge body” (claims 11, 18)
`This claim element includes the words “means for” and therefore
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`
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`presumptively invokes 112/6. The claimed functions performed by the “means”
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`are “driv[ing]” and “converting the rotational motion produced by said electric
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`motor to translational motion to eject said staples from said staple cartridge body,”
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`which require no further construction. IS1001, Claims 11 and 18. The
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`corresponding structures in the ’677 patent that perform this function include (1)
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`the combination of drive nut 610, axial drive assembly 212, and actuation sled 234;
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`(2) the combination of cutting instrument 2332, sled portion 2333, and the drive
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`17
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`nut to which they are attached; and (3) the combination of screw nut arrangement
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`3038, firing bar 3003, cutting instrument 3002, and sled 2033. IS1003, ¶¶ 66-69.
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`In the first embodiment of the ’677 patent, “a drive screw 600 . . . threadedly
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`engages a drive nut 610 that is supported within an engagement section 270 formed
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`on the distal end of the drive beam 266.” IS1001, 12:36-40, Figs. 2, 5; see also
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`11:30-31 (“[A]xial drive assembly 212 . . . comprises a drive beam 266.”). “The
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`distal end of drive beam 266 may include a vertical support strut 271 which
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`supports a knife blade 280 and an abutment surface 283 which engages the central
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`portion of actuation sled 234 during a stapling procedure.” IS1001, 11:35-38.
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`“[R]otation of the drive screw 600 [by motor 562] within the drive nut 610 will
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`drive the drive beam 266 in the distal direction ‘DD’ or in the proximal direction
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`‘PD’ depending upon the direction of rotation of the drive screw 600.” IS1001,
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`12:45-48; see also 14:15-16 (“the motor 562 . . . rotate[s] the drive screw 610”).
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`“As the drive screw 600 is rotated, the drive beam 266 and knife nut 610 are driven
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`in the distal direction ‘DD’ to advance actuation sled 234 through staple cartridge
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`220 to effect ejection of staples and cutting of tissue.” IS1001, 13:57-61. Thus, a
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`POSITA would have understood that the combination of drive nut 610, axial drive
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`assembly 212, and actuation sled 234 performs the claimed functions of the “drive
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`means.” IS1003, ¶ 67.
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`18
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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`In an embodiment of the ’677 patent added to the CIP application, the
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`cutting instrument 2332 “may be, for example, a knife” that “has a sled portion
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`2333 formed thereon.” IS1001, 24:47-54, Figs. 34-38. “[R]otation of the end
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`effector drive shaft 2336 [produced by the electric motor] will cause the cutting
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`instrument 2332 and sled portion 2333 to axially travel through the surgical staple
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`cartridge 2334 to move between a starting position and an ending position. The
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`direction of axial travel of the cutting instrument 2332 depends upon the direction
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`in which the end effector drive shaft 2336 is rotated.” IS1001, 24:54-61; see also
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`19
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`IPR of U.S. Patent No. 8,991,677
`24:67-25:8 (“When the end effector drive shaft 2336 is rotated, the cutting
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`instrument 2332 and sled 2333 will travel longitudinally through the surgical staple
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`cartridge 2334 from the starting position to the ending position, thereby cutting
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`tissue clamped within the surgical end effector 2312. The movement of the sled
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`2333 through the surgical staple cartridge 2334 causes the staples therein to be
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`driven through the severed tissue and against the closed anvil 2324, which turns
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`the staples to fasten the severed tissue.”), 28:63-30:13. Thus, a POSITA would
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`have understood that cutting instrument 2332 and sled portion 2333 are attached to
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`a drive nut, and that the combination of the drive nut, cutting instrument 2332, and
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`sled portion 2333 performs the functions of the “drive means.” IS1003, ¶ 68.
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`
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`In another embodiment added to the CIP application, motor 3011 of surgical
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`tool 3000 generates a “driving force necessary to drive the cutting instrument 3002
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`through tissue and to drive and form staples.” IS1001, 39:56-63. “[T]he driven
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`20
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
`gear 3034 is coupled to a screw shaft 3036 that is in threaded engagement with a
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`screw nut arrangement 3038 that is constrained to move axially (represented by
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`arrow ‘D’). The screw nut arrangement 3038 is attached to the firing bar 3003.
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`Thus, by rotating the screw shaft 3036 in a first direction, the cutting instrument
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`3002 is driven in the distal direction ‘DD’ and rotating the screw shaft in an
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`opposite second direction, the cutting instrument 3002 may be retracted in the
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`proximal direction ‘PD’.” IS1001, 39:63-40:5, Fig. 52; see also 38:46-55
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`(“[S]urgical tool 3000 includes a surgical end effector . . . of the types and
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`constructions described above.”), 19:19-31 (“[S]urgical end effector 2012 further
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`includes a cutting instrument 2032 and a sled 2033. . . . As the cutting instrument
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`2032 is driven distally . . . it forces the sled 2033 distally as well. As the sled 2033
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`is driven distally, its ‘wedged-shaped’ configuration contacts the movable staple
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`drivers and drives them vertically toward the closed anvil 2024.”), Fig. 28. Thus, a
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`POSITA would have understood that the combination of screw nut arrangement
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`3038, firing bar 3003, cutting instrument 3002, and sled 2033 performs the
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`functions of the “drive means.” IS1003, ¶ 69.
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`21
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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`
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`VII. SUMMARY OF HOOVEN AND HEINRICH
`A. Hooven
`Hooven discloses a controller 31 removably connected to an endoscopic
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`surgical cutting and stapling instrument 30 that is capable of applying lines of
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`staples to tissue while cutting the tissue between those staple lines. E.g., IS1004,
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`Figs. 1, 3, 6; IS1003, ¶ 82.
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`22
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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`As shown below, Hooven’s instrument 30 includes a closure nut 77, a firing
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`nut 86, a knife 82, and a wedge 83 that are all driven by a motor-powered threaded
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`rod 71. Id. The motor 45 residing in the instrument 30 is disconnected from its
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`power source, which resides in controller 31, when the instrument 30 is not
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`attached to the controller 31, and is connected to the power source when the
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`instrument 30 is attached to the controller 31. IS1003, ¶ 83; IS1004, 4:24-26. In
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`other words, the motor can receive power only when the surgical stapler is
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`connected to the surgical instrument system that controls the stapler. Id.
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`23
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`Attorney Docket No. 11030-0049IP3
`IPR of U.S. Patent No. 8,991,677
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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, Fig