UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`______________________
`
`IPR2018-00935
`U.S. Patent No. 8,991,677
`______________________
`
`PATENT OWNER ETHICON LLC’S
`PRELIMINARY RESPONSE
`
`
`
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`______________________
`
`IPR2018-00935
`U.S. Patent No. 8,991,677
`______________________
`
`PATENT OWNER ETHICON LLC’S
`PRELIMINARY RESPONSE
`
`
`
`
`
`INTRODUCTION ....................................................................................... 1
`I.
`BACKGROUND ......................................................................................... 5
`II.
`A. Overview Of The 677 Patent ............................................................... 5
`B.
`Prosecution History........................................................................... 10
`C.
`Statutory Disclaimer Of Claims 11-15, 18 ........................................ 11
`III. CLAIM CONSTRUCTION ........................................................................ 11
`A.
`instrument” (claims 1, 16) ................................................................. 12
`B.
`from said staple cartridge body” (claims 11, 18) ............................... 13
`IV. THE PRIOR-ART ...................................................................................... 13
`A. Hooven ............................................................................................. 13
`B.
`Heinrich ............................................................................................ 15
`C. Milliman ........................................................................................... 22
`D. Alesi ................................................................................................. 25
`V. REASONS WHY THE PETITION SHOULD BE DENIED .................. 27
`A. Hooven In View Of Heinrich Does Not Disclose The Claimed
`Configuration Of Motor And Power Source ...................................... 28
`1.
`configured to receive power from a power source. .................. 29
`
`“Drive means for converting the rotational motion produced by
`said electric motor to translational motion to eject said staples
`
`
`
`TABLE OF CONTENTS
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`IPR2018-00935
`U.S. Patent No. 8,991,677
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`Page
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`“Means for removably attaching said housing to the surgical
`
`Hooven in view of Heinrich does not disclose a motor
`
`i
`
`
`
`2.
`is “operably connected” and “operably disconnected”. ........... 31
`B.
`Reasonable Expectation Of Success .................................................. 33
`1.
`Heinrich. ................................................................................. 34
`2.
`combine Hooven and Heinrich ................................................ 38
`3.
`Hooven and Milliman. ............................................................ 41
`4.
`Hooven and Alesi. .................................................................. 41
`5.
`of success. ............................................................................... 42
`VI. CONCLUSION .......................................................................................... 43
`
`
`
`Hooven in view of Heinrich does not disclose a motor that
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`IPR2018-00935
`U.S. Patent No. 8,991,677
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`Petitioner Does Not Establish A Motivation To Combine Or
`
`Ground 1: Petitioner provides no explanation for how to
`combine the
`incompatible systems of Hooven and
`
`Ground 1: Petitioner relies on impermissible hindsight to
`
`Ground 2: Petitioner provides no motivation to combine
`
`Ground 3: Petitioner provides no motivation to combine
`
`Petitioner offers no showing of a reasonable expectation
`
`
`
`
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`U.S. Patent No. 8,991,677
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`
`
`Cases
`
`Arctic Cat Inc. v. Bombardier Recreational Prod. Inc.,
`876 F.3d 1350 (Fed. Cir. 2017) .............................................................. 4, 33, 43
`
`Compass Bank v. Intellectual Ventures II,
`IPR2014-00786, Paper 46 .......................................................................... 38, 41
`
`Corning Inc. v. DSM IP Assets,
`IPR2013-00050, Paper 77 .......................................................................... 38, 41
`
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966)............................................................................................... 4
`
`Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A. De C.V.,
`865 F.3d 1348 (Fed. Cir. 2017) .................................................................. 34, 43
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .................................................................. 34, 43
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.
`688 F.3d 1342 (Fed. Cir. 2012) ............................................................ 28, 33, 41
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................... 3, 38, 39
`
`In re Laskowski,
`871 F.2d 115 (Fed. Cir. 1989) ...................................................................... 4, 39
`
`Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) ........................................................................ 32
`
`Microsoft Corp. v. Multi-Tech Sys., Inc.,
`357 F.3d 1340 (Fed. Cir. 2004) ........................................................................ 12
`
`Tech. Patents LLC v. T-Mobile (UK) Ltd.,
`700 F.3d 482 (Fed. Cir. 2012), cert. denied, 134 S.Ct. 67 (2013) ..................... 12
`
`iii
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`Total Containment, Inc. v. Intelpro Corp.,
`217 F.3d 852 (Fed. Cir. 1999) ................................................................ 4, 39, 40
`
`In re Translogic Tech. Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ........................................................................ 12
`
`Vectra Fitness, Inc. v. TNWK Corp.,
`162 F.3d 1379 (Fed. Cir. 1998) ........................................................................ 11
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) .................................................................... 12, 13
`
`Statutes
`
`35 U.S.C. § 253(a) ................................................................................................ 11
`
`Other Authorities
`
`37 C.F.R. § 1.321(a) ............................................................................................. 11
`
`37 C.F.R. § 42.24(a) ............................................................................................. 46
`
`37 C.F.R. § 42.24(d) ............................................................................................. 46
`
`37 C.F.R. § 42.100(b) ........................................................................................... 12
`
`37 C.F.R. § 42.107(e)............................................................................................ 11
`
`77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012)........................................................ 12
`
`
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`iv
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`U.S. Patent No. 8,991,677
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`EXHIBIT LIST
`
`Description
`
`Ethicon
` Exhibit #
`
`Ex. 2001
`
`U.S. Patent No. 5,964,394 (“Robertson”)
`
`Ex. 2002
`
`U.S. Patent No. 6,231,565 (“Tovey”)
`
`Ex. 2003
`
`Excerpts from Technology Tutorial filed in Ethicon LLC, et al. v.
`Intuitive Surgical, Inc., et al., C.A. No. 17-871 (LPS)(CJB)
`(District of Delaware).
`
`Ex. 2004
`
`Statutory Disclaimer
`
`Ex. 2005
`
`Excerpts from the File History of U.S. Patent No. 8,991,677
`
`v
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`U.S. Patent No. 8,991,677
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`I.
`
`INTRODUCTION
`
`Ethicon is a market leader in developing endocutter1 technology and
`
`commercially released its first endocutter in 1996. Since then, Ethicon has
`
`developed numerous endocutters to address changing surgical needs. In 2011,
`
`Ethicon introduced its first motor-powered endocutter – the ECHELON FLEX™
`
`Powered ENDOPATH® Stapler. Ethicon’s motor-powered endocutters offer
`
`numerous benefits including dramatically reducing the force required to operate an
`
`endocutter and providing reliability across a broad range of tissue thicknesses.
`
`U.S. Patent No. 8,991,677 (“the 677 Patent”) is one of a family of patents
`
`awarded to Ethicon for innovations relating to motor-powered endocutters. The
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`677 Patent is directed to a motor-powered surgical stapling and cutting tool that
`
`attaches to a surgical instrument/surgical instrument system. According to the
`
`embodiment of challenged independent claims 1 and 16, the surgical tool employs
`
`a motor configured to receive power from an available power source but only
`
`selectively receives power when a means for removably attaching the surgical tool
`
`
`1 An endocutter is a surgical instrument that both staples and cuts tissue. The term
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`“stapler” can also be used to refer to this type of device, but can also refer to a
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`device that only staples. Exhibit 2003 includes excerpts of a technology tutorial on
`
`endocutters that was filed in the District of Delaware on June 28, 2018.
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`1
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`U.S. Patent No. 8,991,677
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`to a surgical instrument is operably coupled to the surgical instrument. According
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`to the embodiment of challenged independent claims 6 and 17, the surgical tool is
`
`operably disconnected from an available power source when the housing of the
`
`tool is not attached to a surgical instrument system, and operably connected to the
`
`power source when the housing of the tool is attached to the surgical instrument
`
`system. Ex. 1001 at Abstract, 2:22-3:3, 11:62-12:24; 80:40-64; 81:12-41; 82:25-
`
`67.
`
`The Petition challenges all claims of the 677 Patent on one ground—
`
`obviousness over Hooven in view of Heinrich—and it challenges claims 1-5, and
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`16 on two additional grounds—obviousness over Hooven in view of Heinrich and
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`Milliman, and obviousness over Hooven in view of Heinrich and Alesi. As
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`Petitioner acknowledges, all of these references were made of record during
`
`prosecution of the 677 Patent, and Alesi was discussed and analyzed by the
`
`Examiner. See Petition at 4-5. Further, Hooven is an expired patent owned by
`
`Patent Owner affiliate Ethicon, Inc. with priority dating back to 1992. Petitioner’s
`
`sole argument is therefore premised on the allegation that the claims of the 677
`
`Patent with priority in 2008 are obvious over Ethicon’s own technology filed 16
`
`years earlier. To the contrary, Petitioner’s obviousness ground fails for at least two
`
`reasons.
`
`2
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`First, neither Hooven nor Heinrich teaches or renders obvious a motor in a
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`surgical stapling tool that is configured to receive power from a power source, but
`
`only selectively receives power/is operably connected to power when attached to a
`
`surgical instrument/surgical instrument system. Specifically, Hooven and Heinrich
`
`both disclose motors that are either connected to, or disconnected from, a power
`
`source. Neither reference suggests a surgical stapling tool that includes a motor
`
`that is connected to a power source and is capable of receiving power from it, but
`
`that only selectively receives power from /is only operably connected to the power
`
`source when the surgical tool is attached to a surgical instrument/surgical
`
`instrument system. This is unsurprising, given that the 677 Patent is directed to
`
`developments by Ethicon well after the filing of Hooven. Accordingly, institution
`
`should be denied for this reason alone.
`
`Second, Petitioner’s obviousness grounds do not satisfy the basic standard
`
`for establishing obviousness. Petitioner does not explain how the prior art
`
`references would be combined, as the references disclose different and
`
`incompatible systems. Moreover, Petitioner does not offer a legally cognizable
`
`motivation to combine the references. With respect to the first ground, the Petition
`
`relies solely on the 677 Patent to argue that a person of ordinary skill in the art
`
`would have been motivated to combine the references. This is the exact sort of
`
`impermissible hindsight that cannot support obviousness. KSR Int'l Co. v. Teleflex
`
`3
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`Inc., 550 U.S. 398, 421 (2007) (warning against a “temptation to read into the prior
`
`art the teachings of the invention in issue” and instructing courts to “guard against
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`slipping into use of hindsight” (quoting Graham v. John Deere Co. of Kansas City,
`
`383 U.S. 1, 36 (1966))); see also Total Containment, Inc. v. Intelpro Corp., 217
`
`F.3d 852; 1999 WL 717946 at *5 n.4 (Fed. Cir. 1999) (“It is impermissible ‘to use
`
`the claimed invention itself as a blueprint for piecing together elements in the prior
`
`art to defeat the patentability of the claimed invention....’”); In re Laskowski, 871
`
`F.2d 115, 117 (Fed. Cir. 1989) (“the only source of the suggestion is [the patent in
`
`suit]; there is no prior art teaching that would provide the motivation”).
`
`With respect to the second and third grounds, Petitioner fails to set forth any
`
`motivation to combine the references. Specifically, Petitioner offers no motivation
`
`to combine Hooven with Milliman or Alesi.
`
`Finally, Petitioner fails to offer any evidence of reasonable expectation of
`
`success in the combination of any of the references. This failure alone is grounds
`
`to deny institution. See Arctic Cat Inc. v. Bombardier Recreational Prod. Inc., 876
`
`F.3d 1350, 1360–61 (Fed. Cir. 2017) (“where a party argues a skilled artisan would
`
`have been motivated to combine references, it must show the artisan would have
`
`had a reasonable expectation of success from doing so”). 2
`
`
`2 All emphasis added unless otherwise noted.
`
`4
`
`
`
`
`
`For these reasons, and the additional reasons explained in detail below,
`
`Patent Owner respectfully requests that the Board deny institution as all grounds
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`IPR2018-00935
`U.S. Patent No. 8,991,677
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`challenging the 677 Patent.
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`II. BACKGROUND
`
`A. Overview Of The 677 Patent
`
`The 677 Patent is directed to a novel implementation of a “detachable
`
`motor-powered surgical instrument”—in the case of the challenged claims, a
`
`surgical cutting and stapling instrument. Ex. 1001 at Abstract, 80:40-83:17. The
`
`motor-powered surgical instrument includes a housing and a “motor [that] is
`
`configured to receive power from a power source such that the motor can only
`
`selectively receive power from the power source when the means for removably
`
`attaching the housing to the surgical instrument is operably coupled to the surgical
`
`instrument.” Id. at 2:36-42; see also id. at Abstract, 11:62-12:24. The 677 Patent
`
`also describes an “electrical motor [that] is operably disconnected from a power
`
`source when the housing is not attached to the surgical instrument system, and …
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`operably connected to the power source when the housing is attached to the
`
`surgical instrument system.” Id. at 2:65-3:3.
`
`The 677 Patent discloses that surgical staplers were known in the art,
`
`including surgical stapling tools that are “configured to operate with disposable
`
`loading units (DLU’s).” Id. at 1:54-2:4. The advantage to using a DLU is that
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`5
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`once “the procedure is completed, the entire DLU is discarded.” Id. at 2:4-5. The
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`677 Patent identifies the Milliman reference (Ex. 1006) as one of these known
`
`surgical stapling tools, and incorporates the disclosure of Milliman by reference.
`
`Id. at 2:7-11.
`
`The disadvantage to existing surgical stapling tools is that “prior disposable
`
`loading units… require the clinician to continuously ratchet the handle” of the tool
`
`in order to operate the device. Id. at 2:13-15. Thus, “[t]here is a need for a
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`surgical stapling apparatus configured for use with a disposable loading unit that is
`
`driven by a motor contained in the disposable loading unit.” Id. at 2:15-18. In an
`
`exemplary embodiment, the 677 Patent discloses a DLU that includes a motor
`
`configured to receive power from a power source supported within the housing of
`
`the instrument. Id. at 2:33-42. The motor and power source are further configured
`
`so that the motor “can only selectively receive power… when the means for
`
`removably attaching the housing to the surgical instrument is operably coupled to
`
`the surgical instrument.” Id. The 677 Patent also describes an embodiment where
`
`the motor is “operably connected” to an available power source when the housing
`
`of the surgical tool is attached to a surgical instrument system and otherwise
`
`“operably disconnected” from the power source. Id. at 2:65-3:3. This
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`configuration of the power source (a battery) with the motor “prevent[s] the battery
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`526 from being drained during non-use.” Id. at 11:62-12:24.
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`6
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`Figure 1 of the 677 Patent is not an embodiment of the patent, but discloses
`
`“a disposable loading unit 16 of the present invention that is coupled to a
`
`conventional surgical cutting and stapling apparatus 10.” Id. at 10:54-58.
`
`Conventional Apparatus
`
`DLU of Present
`Invention
`
`
`
`The 677 Patent incorporates Milliman by reference to disclose the elements of the
`
`conventional apparatus 10, and does “not discuss the various components of the
`
`apparatus 10 and their operation… beyond what is necessary to describe the
`
`operation of the disposable loading unit 16 of the present invention.” Id. at 10:58-
`
`65.
`
`As illustrated in Figure 1, the DLU 16 includes a “tool assembly 17 for
`
`performing surgical procedures such as cutting tissue and applying staples on each
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`7
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`U.S. Patent No. 8,991,677
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`side of the cut.” Id. at 11:12-14. Tool assembly 17 includes a cartridge 18, which
`
`may contain staples, and an anvil 20, which provides a series of concavities for
`
`forming the closures of the staples. Id. at 11:14-21.
`
`Figure 2 provides additional detail of the construction of DLU 16:
`
`
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`Tool assembly 17 also includes a sled 234, which is configured to drive the staples
`
`in staple cartridge 200 toward the anvil 20 as the sled is driven down the tool
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`assembly by drive beam 266. Id. at 11:24-28, 11:35-38. The drive beam 266
`
`“supports a knife blade 280 and an abutment surface 283 which engages the central
`
`portion of actuation sled 234 during a stapling procedure.” Id. at 11:35-38. This
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`permits the knife blade 280 to travel “slightly behind actuation sled 234… to form
`
`an incision between rows of stapled body tissue.” Id. at 11:38-42.
`
`Figure 2 depicts motor 562 configured to receive power from battery 526
`
`within the housing. The motor cavity 560 and battery switch portion 520 are
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`depicted in greater detail in Figure 3:
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`8
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`Battery 526 is housed in battery holder 524. Id. at 11:62-66. There are two battery
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`contacts, 528 and 530, “mounted in electrical contact with the battery 526 and also
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`protrud[ing] out of the battery holder 524 to slide along the inside wall 523 of the
`
`battery cavity 522.” Id. at 11:66-12:7. Battery holder 524 is configured to receive
`
`control rod 52 when DLU 16 is attached to an apparatus. Id. at 12:7-11. Along the
`
`inside wall 523 is a series of three contacts–540, 542, and 544–that can make
`
`contact with battery contacts 528 and 530 when control rod 52 is inserted into
`
`battery holder 524. Id. at 12:11-24. The battery and motor are operably
`
`connected, and power is selectively provided to the motor, only when the control
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`rod of the surgical instrument system is inserted into the DLU when the DLU is
`
`attached to the surgical instrument system.
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`9
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`B.
`
`Prosecution History
`
`As Petitioner acknowledges, the prosecution history of the 677 Patent and its
`
`parent applications is extensive, and all of the prior art references were made of
`
`record during prosecution. See Petition at 13-16.
`
`Contrary to Petitioner’s argument, the Examiner analyzed Alesi (Ex. 1010)
`
`during prosecution of the 677 Patent, not just its parent applications. See Ex. 2005
`
`p. 5; Petition at 13-16. In the only office action taken during the prosecution of the
`
`677 Patent, the Examiner rejected the claims that would issue as claims 11-15 as
`
`anticipated by Alesi. Id. The Examiner found that all other claims were allowable
`
`over Alesi. Id. at 6. The Examiner further rejected all claims under a double
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`patenting rejection to a number of Ethicon’s ground breaking patents in the field.
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`In response, Ethicon amended claim 11 to add the limitation that the
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`“electric motor selectively receives power from a power source only when said
`
`housing is coupled to said surgical instrument system.” Id. at 13. Ethicon also
`
`executed the necessary terminal disclaimers to resolve the double patenting
`
`rejections. Id.
`
`A notice of allowance for all claims of the 677 Patent issued less than one
`
`month later. Id. at 38.
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`10
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`C.
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`Statutory Disclaimer Of Claims 11-15, 18
`
`On September 7, 2018, Ethicon filed with the U.S. Patent and Trademark
`
`Office a statutory disclaimer of claims 11-15 and 18 of the 677 Patent under 35
`
`U.S.C. § 253(a) and 37 C.F.R. § 1.321(a). A copy of the statutory disclaimer is
`
`submitted as Exhibit 2004 in this proceeding. Based on this disclaimer, the 677
`
`Patent is to be treated as though claims 11-15 and 18 never existed. Vectra
`
`Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (“This court
`
`has interpreted the term ‘considered as part of the original patent’ in section 253 to
`
`mean that the patent is treated as though the disclaimed claims never existed.”).
`
`As a result of the statutory disclaimer of claims 11-15 and 18, and pursuant to 37
`
`C.F.R. § 42.107(e), it is respectfully submitted that the institution decision in this
`
`proceeding should be based only on the remaining challenged claims—1-10, 16,
`
`and 17—of the 677 Patent.
`
`Ethicon’s disclaimer is relevant to this response. Independent claims 1, 6,
`
`16, and 17 are directed to different embodiments than independent claims 11 and
`
`18. In relevant part, the surviving claims are directed to a different arrangement of
`
`the motor and power source, as discussed in detail in Section V, below.
`
`III. CLAIM CONSTRUCTION
`
`Claims of an unexpired patent are construed using the broadest reasonable
`
`construction in light of the specification of the patent. See Office Patent Trial
`
`11
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`Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012); 37 C.F.R.
`
`§ 42.100(b). There is a presumption that claim terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the art in
`
`the context of the entire disclosure. In re Translogic Tech. Inc., 504 F.3d 1249,
`
`1257 (Fed. Cir. 2007). Although it is improper to read a limitation from the
`
`specification into the claims, the claims still must be read in view of the
`
`specification of which they are a part. See Microsoft Corp. v. Multi-Tech Sys., Inc.,
`
`357 F.3d 1340, 1347 (Fed. Cir. 2004). The specification may confirm the plain
`
`meaning of the term. Tech. Patents LLC v. T-Mobile (UK) Ltd., 700 F.3d 482 (Fed.
`
`Cir. 2012), cert. denied, 134 S.Ct. 67 (2013).
`
`A.
`
`“Means for removably attaching said housing to the surgical
`instrument” (claims 1, 16)
`
`For the purposes of this proceeding, Ethicon does not dispute Petitioner’s
`
`argument that the function performed by the “means” is “removably attaching said
`
`housing to the surgical instrument.” See Petition at 16. Moreover, Ethicon does
`
`not dispute that the “engagement nubs 254,” illustrated in Figure 2, are one such
`
`corresponding structure. See id. at 17.
`
`Ethicon disputes the implication in the Petition that “engagement nubs 254,”
`
`are the only such corresponding structure; however, this dispute is not relevant to
`
`any issues in this proceeding and need not be resolved at this stage. See Vivid
`
`12
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`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (terms
`
`are construed “only to the extent necessary to resolve the controversy”).
`
`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)
`
`As discussed in Section II(C), supra, Ethicon has filed a statutory disclaimer
`
`for claims 11-15, and 18. As these claims are no longer in dispute, this term does
`
`not require construction. Vivid Techs., Inc., 200 F.3d at 803.
`
`IV. THE PRIOR-ART
`
`A. Hooven
`
`Hooven is an expired patent that was owned by an affiliate of Patent Owner
`
`and was before the Examiner during the prosecution of the 677 Patent. Hooven is
`
`directed to an endoscopic surgical system which “will automatically sense physical
`
`properties of the tissue on which the procedure is being conducted and/or certain
`
`parameters of an endoscopic surgical instrument.” Ex. 1004 at Abstract, 1:11-16.
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`Hooven states that endoscopic surgery presents certain challenges, such as the loss
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`of tactile feedback for the surgeon and the need to provide “the surgeon … greater
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`control over the instrument.” Id. at 1:64-2:8. The allegedly inventive concept of
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`Hooven was an endoscopic surgical system that “provid[es] for improved
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`manipulation and control of the instrument during the procedure” and “sensing
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`U.S. Patent No. 8,991,677
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`feedback to the surgeon to compensate for the loss of tactile feedback.” Id. at
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`2:36-42.
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`The endoscopic surgical system is illustrated in Figure 1:
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`In this figure, “an endoscopic stapling and cutting instrument 30 is interconnected
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`with a controller 31 and a video display monitor 32.” Id. at 4:15-17. The surgical
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`instrument 30 contains a DC motor, the controls for the surgeon, and a “video
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`display switch” to provide feedback to the surgeon in the handle portion. Id. at
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`4:54-64. Controller 31 includes the power supply for the motor “to supply power
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`to the instrument.” Id. 4:17-25.
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`The surgical instrument 30 is illustrated in greater detail in Figure 2:
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`Handle portion 40 contains the DC motor, control switches for the surgeon, and the
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`optional video display switch. Id. at 4:54-64. “Extending from this handle portion
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`is a shaft portion 41,” which comprises a “rotating axially flexible, torsionally stiff
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`shaft.” Id. at 4:35-37, 5:14-21. The head (42) is connected to the flexible shaft 41
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`“either by a press fit or ultrasonic welding or other similar means.” Id. at 5:31-33.
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`In the embodiment disclosed in Figures 2 through 9, “the head portion is a linear
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`stapler and cutter.” Id. at 4:45-46.
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`B. Heinrich
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`Heinrich was before the Examiner during the prosecution of the 677 Patent.
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`Heinrich is directed to surgical instruments “and at least one micro-electro-
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`mechanical system (MEMS) device operatively connected to the surgical
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`instrument for at least one of sensing a condition, measuring a parameter and
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`controlling the condition and/or parameter.” Ex. 1005 at Abstract; see also id. at
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`[0003]-[0004].
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`Heinrich describes MEMS as “integrated micro devices or systems
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`combining electrical and mechanical components… fabricated using integrated
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`circuitry.” Id. at [0007]. These devices “range in size from micrometers to
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`millimeters” and can “sense, control and/or actuate on the micro scale.” Id.
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`Heinrich describes a need “for surgical instruments that can sense a multitude of
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`parameters and factors, such as, … the distance between the tissue contacting
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`surfaces of the surgical instrument.” Id. at [0011]. Thus, Heinrich discloses
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`“stapling instruments and energy based surgical instruments for monitoring,
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`controlling and regulating conditions and/or parameters associated with the
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`performance of various mechanical, electro-mechanical and electrosurgical
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`procedures.” Id. at [0012].
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`Heinrich does not disclose any surgical instruments of its own design, but
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`incorporates by reference other inventors’ instruments and illustrates how MEMS
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`devices might be applied to said device. Heinrich provides four embodiments of
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`“surgical staplers including MEMS devices ‘M’.” Id. at [0082]. Figure 1
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`illustrates the surgical stapler disclosed in U.S. Patent No. 5,964,394 (“Robertson,”
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`U.S. Patent No. 8,991,677
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`Ex. 2001):
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`Ex. 1005 at [0082], [0087]. Figure 3 illustrates the “endoscopic gastrointestinal
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`anastomotic stapler” disclosed in Milliman:
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`Id. at [0092], [0099]. Heinrich further discloses embodiments of a surgical
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`instrument for placing clips in laparoscopic or endoscopic procedures” in Figure 5,
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`and an electrosurgical device for coagulation in Figure 6, both of which have had
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`MEMS devices added (labeled “M”):
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`Id. at [0107], [0114]-[0115]. Heinrich discloses that “[p]referably, as seen in FIG.
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`6, MEMS devices ‘M’ are electrically coupled to a control box 562 via wire leads
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`560.” Id. at [0127]. Of the handheld unpowered tools shown in Figures 1-6A,
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`only the tool in Figure 3 is a surgical cutting and stapling instrument.
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`In addition to these embodiments of Heinrich that rely on unpowered
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`surgical instruments, Heinrich discloses four embodiments of “a robotic system
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`coupled to a loading unit, including an end effector for applying” surgical staples,
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`electrosurgical energy, vessel clips, and a vascular suture in Figures 9-12,
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`respectively:
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`Id. at [0064]-[0067]. The embodiment of Figure 9 is an adaptation of the surgical
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`stapler disclosed in Figure 1 (Robertson). Id. at [0142]. Similarly, the
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`embodiment of Figure 10 is an adaptation of Figure 6, and the embodiment of
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`Figure 11 is an adaptation of Figure 5. Id. at [0143], [0148]. Heinrich incorporates
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`by reference U.S. Patent No. 6,231,565 (“Tovey”) (Ex. 2002) for the disclosure of
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`a robotic surgical system. Id. The robot (616), monitor (614), and actuation
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`assembly (612) of this robotic surgical system are illustrated in Figure 7:
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`Figures 7 and 9-12 of Heinrich are taken directly from Tovey. Neither
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`Heinrich nor Tovey discloses a surgical cutting and stapling tool coupled to a
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`robotic system.
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`C. Milliman
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`Milliman was disclosed during the prosecution of the 677 Patent, and is
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`incorporated by reference into the 677 Patent’s specification for disclosure of the
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`conventional stapling device. The Examiner had the Milliman reference before
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`him during prosecution. As Petitioner relies on only a portion of Milliman, only
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`the relevant disclosures are discussed below.
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`Milliman is directed to an unpowered “surgical stapling device particularly
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`suited for endoscopic procedures.” Ex. 1006 at Abstract. Figure 1 of Milliman
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`illustrates the preferred embodiment of the surgical stapling apparatus:
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`Id. at 3:21-22. Figure 4 illustrates a perspective view of the handle assembly of
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`Figure 1, and the mechanism by which the user articulates the stapler:
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`Id. at 3:28-29, 6:48-7:10.
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`The user pulls movable handle 24 toward stationary handle 22 “through an
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`actuation stroke to clamp tissue and to effect ejection of staples from the
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`disposable loading unit.” Id. at 2:44-48. When movable handle 24 is articulated,
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`engagement finger 43 of driving pawl 42 is moved “into contact with toothed rack
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`48 of actuation shaft 46 to advance the actuation shaft linearly” away from the
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`handle assembly. Id. at 6:64-67. The actuation shaft causes “corresponding linear
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`advancement of control rod 52.” Id. at 7:1-3. “Control rod 52 is connected at its
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`distal end to axial dive assembly 212 (FIG. 48), including drive beam 266, such
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`that distal movement of control rod 52 effects distal movement of drive beam
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`266.” Id. at 14:3-6. One complete stroke of the handle “advances actuation
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