throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`______________________
`
`IPR2018-00934
`U.S. Patent No. 8,998,058
`______________________
`
`PATENT OWNER ETHICON LLC’S
`PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`

`

`INTRODUCTION ....................................................................................... 1
`I.
`BACKGROUND ......................................................................................... 4
`II.
`A. Overview Of The 058 Patent ............................................................... 4
`B.
`Prosecution History............................................................................. 8
`C.
`Statutory Disclaimer Of Claims 11-18 ................................................ 9
`CLAIM CONSTRUCTION .................................................................................. 10
`A.
`instrument” (claim 1) ........................................................................ 10
`III. THE PRIOR ART ....................................................................................... 11
`A. Hooven ............................................................................................. 11
`B.
`Heinrich ............................................................................................ 13
`IV. REASONS WHY THE PETITION SHOULD BE DENIED .................. 20
`A. Hooven In View Of Heinrich Does Not Disclose The Claimed
`Motor Configured To Receive Power From A Power Source ............ 20
`B.
`Reasonable Expectation Of Success .................................................. 23
`1.
`incompatible systems of Hooven and Heinrich. ...................... 24
`2.
`of success. ............................................................................... 27
`3.
`Petitioner relies solely on impermissible hindsight.................. 27
`V.
`CONCLUSION .......................................................................................... 30
`
`“Means for removably attaching said housing to the surgical
`
`
`
`TABLE OF CONTENTS
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`Page
`
`
`Petitioner Does Not Establish A Motivation To Combine Or
`
`Petitioner provides no explanation for how to combine the
`
`Petitioner offers no showing of a reasonable expectation
`
`i
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`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`
`
`
`Cases
`
`Arctic Cat Inc. v. Bombardier Recreational Prod. Inc.,
`876 F.3d 1350 (Fed. Cir. 2017) ........................................................................ 27
`
`Compass Bank v. Intellectual Ventures II,
`IPR2014-00786, Paper 46 .......................................................................... 26, 29
`
`Corning Incorp. v. DSM IP Assets,
`IPR2013-00050, Paper 77 .......................................................................... 26, 29
`
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966)............................................................................................... 3
`
`Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A. De C.V.,
`865 F.3d 1348 (Fed. Cir. 2017) ........................................................................ 23
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ........................................................................ 27
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.
`688 F.3d 1342 (Fed. Cir. 2012) .................................................................. 20, 23
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ..................................................................................... 3, 28
`
`In re Laskowski,
`871 F.2d 115 (Fed. Cir. 1989) ...................................................................... 3, 28
`
`Microsoft Corp. v. Multi-Tech Sys., Inc.,
`357 F.3d 1340 (Fed. Cir. 2004) ........................................................................ 10
`
`Total Containment, Inc. v. Intelpro Corp.,
`217 F.3d 852 (Fed. Cir. 1999) ...................................................................... 3, 28
`
`In re Translogic Tech. Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ........................................................................ 10
`
`ii
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`

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`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`Vectra Fitness, Inc. v. TNWK Corp.,
`162 F.3d 1379 (Fed. Cir. 1998) .......................................................................... 9
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) .......................................................................... 10
`
`Statutes
`
`35 U.S.C. § 253(a) .................................................................................................. 9
`
`Other Authorities
`
`37 C.F.R. § 1.321(a) ............................................................................................... 9
`
`37 C.F.R. § 42.24(a) ............................................................................................. 31
`
`37 C.F.R. § 42.24(d) ............................................................................................. 31
`
`37 C.F.R. § 42.100(b) ........................................................................................... 10
`
`37 C.F.R. § 42.107(e).............................................................................................. 9
`
`77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012)........................................................ 10
`
`
`
`
`
`
`
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`iii
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`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`
`
`
`Ethicon
` Exhibit #
`
`EXHIBIT LIST
`
`Description
`
`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
`
`iv
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`

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`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`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. 8,998,058 (“the 058 Patent”) is one of a family of patents
`
`awarded to Ethicon for innovations relating to motor-powered endocutters. The
`
`058 Patent is directed to a motor-powered surgical stapling and cutting tool that
`
`attaches to a surgical instrument system. The surgical tool employs a motor
`
`configured to receive power from an available power source but only selectively
`
`receives power when a housing connector on the surgical tool is operably
`
`coupled/attached to the surgical instrument system. Ex. 1001 at 2:21-65.
`
`
`1 An endocutter is a surgical instrument that both staples and cuts tissue. The term
`
`“stapler” can also be used to refer to this type of device, but can also refer to a
`
`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.
`
`1
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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`The Petition challenges all claims of the 058 Patent on only one ground,
`
`obviousness over Hooven in view of Heinrich. As Petitioner acknowledges,
`
`Hooven and Heinrich were both made of record during prosecution of the 058
`
`Patent. See Petition at 4. 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 058 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.
`
`First, neither Hooven nor Heinrich teaches a motor in a surgical stapling tool
`
`that is configured to receive power from a power source, but only selectively
`
`receives power when a housing connector of the surgical tool is attached to the
`
`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 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 the power source when a housing connector on the surgical tool is
`
`attached to a surgical instrument system. This is unsurprising, given that the 058
`
`Patent is directed to developments by Ethicon well after the filing of Hooven.
`
`Accordingly, institution should be denied for this reason alone.
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`2
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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`Second, Petitioner’s obviousness ground does not satisfy the basic standard
`
`for establishing obviousness. Petitioner does not explain how the systems of
`
`Hooven and Heinrich would be combined, as the two references disclose different
`
`and competing control systems. Moreover, Petitioner does not offer a legally
`
`cognizable motivation to combine the references. The Petition does not identify
`
`any disclosure in any prior art reference to support a motivation to combine, but
`
`instead relies solely on the 058 Patent to support its reasoning. This is the exact
`
`sort of impermissible hindsight that cannot support obviousness. KSR Int'l Co. v.
`
`Teleflex 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 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 *4 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”). Finally, Petitioner fails to offer any evidence of
`
`reasonable expectation of success in the combination.
`
`3
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`

`

`
`
`For these reasons, and the additional reasons explained in detail below,
`
`Patent Owner respectfully requests that the Board deny institution.
`
`IPR2018-00934
`U.S. Patent No. 8,998,058
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`II. BACKGROUND
`
`A. Overview Of The 058 Patent
`
`The 058 Patent is directed to a novel implementation of a “detachable
`
`motor-powered surgical instrument”—in the case of the asserted claims, a surgical
`
`cutting and stapling instrument. Ex. 1001 at Abstract, 80:8-81:20. The motor-
`
`powered surgical instrument includes a housing connector and an “electric[al]
`
`motor … configured to receive power from a power source such that the electrical
`
`motor can only selectively receive power from the power source when the housing
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`connector is [attached/operably coupled] to the surgical instrument.” Id. at 2:21-65.
`
`The 058 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
`
`once “the procedure is completed, the entire DLU is discarded.” Id. at 2:4-5. The
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`058 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
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`4
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`in order to operate the device. Ex. 1001 at 2:12-14. Thus, “[t]here is a need for a
`
`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 2:14-17. In an
`
`exemplary embodiment, the 058 Patent discloses a motor for driving the DLU that
`
`is “configured to receive power from a power source”—a battery. Id. at 2:62. The
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`battery is configured so that the motor only receives power from the battery when
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`the disposable loading unit is “coupled to the surgical instrument.” Id. at 2:40-43,
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`11:29-58. This configuration of the battery with the motor “prevent[s] the battery
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`526 from being drained during non-use.” Id. at 11:54-58.
`
`Figure 1 of the 058 Patent is not an embodiment of the patent, but discloses
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`“a disposable loading unit 16 of the present invention that is coupled to a
`
`conventional surgical cutting and stapling apparatus 10.” Id. at 10:21-25.
`
`5
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`

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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`Conventional Apparatus
`
`
`
`DLU of Present
`Invention
`
`
`
`The 058 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.” Ex. 1001 at
`
`10:25-32.
`
`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
`
`side of the cut.” Id. at 10:45-48. Tool assembly 17 includes a cartridge assembly
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`18, which is supported in carrier 216, and an anvil 20, which provides a series of
`
`concavities for forming the closures of the staples. Id. at 10:48-55.
`
`6
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`

`

`
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`Figure 2 provides additional detail of the construction of DLU 16:
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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`Tool assembly 17 also includes a sled 234, which is configured to drive the staples
`
`in staple cartridge 220 toward the anvil 20 as the sled is driven down the tool
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`assembly by drive beam 266. Ex. 1001 at 10:58-67. The drive beam 266
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`“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 11:2-5. 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 11:5-9.
`
`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
`
`depicted in greater detail in Figure 3:
`
`7
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`

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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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`Battery 526 is housed in battery holder 524. Ex. 1001 at 11:30-33. There are two
`
`battery contacts, 528 and 530, “mounted in electrical contact with the battery 526
`
`and also protrud[ing] out of the battery holder 524 to slide along the inside wall
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`523 of the battery cavity 522.” Id. at 11:37-41. Battery holder 524 is configured to
`
`receive control rod 52 when DLU 16 is attached to an apparatus. Id. at 11:41-45.
`
`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 11:45-47. Power is selectively provided to the
`
`motor only when the control rod of the surgical instrument system is inserted into
`
`the DLU when the DLU is attached to the surgical instrument system.
`
`B.
`
`Prosecution History
`
`As Petitioner acknowledges, the prosecution history of the 058 Patent and its
`
`parent applications is extensive, and both prior art references were made of record
`
`during prosecution. See Petition at 12-14.
`
`8
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`

`

`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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`The application that issued as the 058 Patent was subject to only one office
`
`action, in which the Examiner rejected the claims on a double patenting rejection.
`
`Ex. 1002 at 78-85. Ethicon filed the necessary terminal disclaimers, and the 058
`
`Patent issued.
`
`C.
`
`Statutory Disclaimer Of Claims 11-18
`
`On September 7, 2018, Ethicon filed with the U.S. Patent and Trademark
`
`Office a statutory disclaimer of claims 11-18 of the 058 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 058 Patent is to be
`
`treated as though claims 11-18 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 11-18, 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 of the 058 Patent.
`
`Ethicon’s disclaimer is relevant to this response. Independent claims 1 and 6
`
`are directed to different embodiments than independent claims 11 and 15. In
`
`relevant part, both claims 1 and 6 are directed to a different arrangement of the
`
`motor and power source as discussed in more detail in Section V below.
`
`9
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`

`

`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`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
`
`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).
`
`A.
`
`“Means for removably attaching said housing to the surgical
`instrument” (claim 1)
`
`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 15. Moreover, Ethicon does
`
`not dispute that the “engagement nubs 254,” illustrated in Figure 2, are one such
`
`corresponding structure. See id.
`
`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
`
`10
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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.”)
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`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 058 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.
`
`Hooven states that endoscopic surgery presents certain challenges, such as the loss
`
`of tactile feedback for the surgeon and the need to provide “the surgeon … greater
`
`control over the instrument.” Id. at 1:64-2:8. The allegedly inventive concept of
`
`Hooven was an endoscopic surgical system that “provid[es] for improved
`
`manipulation and control of the instrument during the procedure” and “sensing
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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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`11
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`

`

`
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`The endoscopic surgical system is illustrated in Figure 1:
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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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.” Ex. 1004 at 4:15-17. The
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`surgical instrument 30 contains a DC motor, the controls for the surgeon, and a
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`“video display switch” to provide feedback to the surgeon in the handle portion.
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`Id. at 4:54-64. Controller 31 includes the power supply for the motor “to supply
`
`power to the instrument.” Id. at 4:17-25.
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`12
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`

`
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`The surgical instrument 30 is illustrated in greater detail in Figure 2:
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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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. Ex. 1004 at 4:54-64. “Extending from this handle
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`portion is a shaft portion 41, which comprises a “rotating axially flexible,
`
`torsionally stiff shaft.” Id. at 4:35-37, 5:14-21. The head (42) is connected to the
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`flexible shaft 41 “either by a press fit or ultrasonic welding or other similar
`
`means.” Id. at 5:31-33. In the embodiment disclosed in Figures 2 through 9, “the
`
`head portion is a linear stapler and cutter.” Id. at 4:45-46.
`
`B. Heinrich
`
`Heinrich was before the Examiner during the prosecution of the 058 Patent.
`
`Heinrich is directed to surgical instruments “and at least one micro-
`
`13
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`

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`IPR2018-00934
`U.S. Patent No. 8,998,058
`
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`electromechanical system (MEMS) device operatively connected to the surgical
`
`instrument for at least one of sensing a condition, measuring a parameter and
`
`controlling the condition and/or parameter.” Ex. 1005 at Abstract; see also [0003]-
`
`[0004].
`
`Heinrich describes MEMS as “integrated micro devices or systems
`
`combining electrical and mechanical components… fabricated using integrated
`
`circuitry.” Id. at [0007]. These devices “range in size from micrometers to
`
`millimeters” and can “sense, control and/or actuate on the micro scale.” Id.
`
`Heinrich describes a need “for surgical instruments that can sense a multitude of
`
`parameters and factors, such as, … the distance between the tissue contacting
`
`surfaces of the surgical instrument.” Id. at [0011]. Thus, Heinrich discloses
`
`“stapling instruments and energy based surgical instruments for monitoring,
`
`controlling and regulating conditions and/or parameters associated with the
`
`performance of various mechanical, electro-mechanical and electrosurgical
`
`procedures.” Id. at [0012].
`
`Heinrich does not disclose any surgical instruments of its own design, but
`
`incorporates by reference other inventors’ instruments and illustrates how MEMS
`
`devices might be applied to said device. Heinrich provides four embodiments of
`
`“surgical staplers including MEMS devices ‘M’.” Id. at [0082]. Figure 1
`
`14
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`

`

`
`illustrates the surgical stapler disclosed in U.S. Patent No. 5,964,394 (“Robinson,”
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`Ex. 2001):
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`Ex. 1005 at [0082], [0087]. Figure 3 illustrates the “endoscopic gastrointestinal
`
`anastomotic stapler” disclosed in Milliman:
`
`
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`15
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`

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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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`Id. at [0092], [0099]. Heinrich further discloses embodiments of “a surgical
`
`instrument for placing clips in laparoscopic or endoscopic procedures” in Figure 5,
`
`and an electrosurgical device for coagulation in Figure 6, both of which have had
`
`MEMS devices added (labeled “M”):
`
`16
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`IPR2018-00934
`IPR2018-00934
`U.S. Patent No. 8,998,058
`US. Patent No. 8,998,058
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`17
`17
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`Ex. 1005 at [0107], [0114]-[0115]. Heinrich discloses that “[p]referably, as seen in
`
`FIG. 6, MEMS devices ‘M’ are electrically coupled to a control box 562 via wire
`
`leads 560.” Id. at [0127]. Of the handheld unpowered tools shown in Figures 1-
`
`6A, only the tool in Figure 3 is a surgical cutting and stapling instrument.
`
`In addition to these embodiments of Heinrich that rely on unpowered
`
`surgical instruments, Heinrich discloses four embodiments of “a robotic system
`
`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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`18
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`IPR2018-00934
`U.S. Patent No. 8,998,058
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`
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`Ex. 1005 at [0064]-[0067]. The embodiment of Figure 9 is an adaptation of the
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`surgical stapler disclosed in Figure 1 (Robertson). Id. at [0142]. Similarly, the
`
`embodiment of Figure 10 is an adaptation of Figure 6, and the embodiment of
`
`Figure 11 is an adaptation of Figure 5. Id. at [0143], [0148]. Heinrich incorporates
`
`19
`
`

`

`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`by reference U.S. Patent No. 6,231,565 (“Tovey”) (Ex. 2002) for the disclosure of
`
`a robotic surgical system. Id. Figures 9-12 of Heinrich are taken directly from
`
`Tovey. Neither Heinrich nor Tovey discloses a surgical cutting and stapling tool
`
`coupled to a robotic system.
`
`V. REASONS WHY THE PETITION SHOULD BE DENIED
`
`Petitioner has advanced only one ground for institution—obviousness based
`
`on Hooven in view of Heinrich. The Petition fails for at least two reasons. First,
`
`Petitioner has failed to show that either prior art reference discloses or renders
`
`obvious the “motor configured to receive power from a power source” limitation
`
`found in independent claims 1 and 6.
`
`Second, Petitioner has failed to carry its burden to show a motivation to
`
`combine the prior art as well as a reasonable expectation of success. See Kinetic
`
`Concepts, Inc. v. Smith & Nephew, Inc. 688 F.3d 1342, 1360 (Fed. Cir. 2012) (It is
`
`the Petitioner’s burden, however, to show “that a skilled artisan would have been
`
`motivated to combine the teachings of the prior art references to achieve the
`
`claimed invention, and that the skilled artisan would have had a reasonable
`
`expectation of success in doing so.”)
`
`A. Hooven In View Of Heinrich Does Not Disclose The Claimed Motor
`Configured To Receive Power From A Power Source
`
`Independent claims 1 and 6 each require a “motor configured to receive
`
`power from a power source.” Ex. 1001 at 80:27-28, 80:67-81:1. Contrary to
`
`20
`
`

`

`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`Petitioner’s argument, this limitation is separate from the limitation that the “motor
`
`can only selectively receive power from said power source when said [housing
`
`connector/means for removably attaching said housing to the surgical instrument]
`
`is [attached/operably coupled] to the surgical instrument [system].” Id. at 80:28-
`
`32; 81:2-4. These separate but related limitations are illustrated in the embodiment
`
`of Figure 3 of the 058 Patent. In this embodiment, the motor is configured to
`
`receive power from the battery 426. Separately, the contact arrangement is
`
`configured such that the motor can only selectively receive power from the battery
`
`when the housing connector of the stapling unit is connected to a surgical
`
`instrument.
`
`The independent nature of these limitations is apparent from the claims
`
`themselves, but it is further highlighted when claims 1 and 6 are contrasted with
`
`claims 11 and 15, which Ethicon has disclaimed. Claim 11 differs from claims 1
`
`and 6 in that it has only one limitation related to the motor and power source: an
`
`“electric motor [that] is configured to receive power from a power supply only
`
`when said housing is attached to the surgical instrument.” Id. at 81:44-46. Unlike
`
`claims 1 and 6, this limitation does not require a configuration of the motor and
`
`power supply separate from the connection between the DLU and surgical
`
`instrument.
`
`21
`
`

`

`
`
`Petitioner relies on Hooven to disclose this limitation. Petition at 38-39.
`
`Petitioner relies on Figure 1 and its associated disclosure:
`
`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`
`Petitioner’s entire argument is that “DC motor 45 is in handle 40… [a]nd the
`
`power supply for DC motor 45 is in controller 31.” Petition at 38. Thus, Petitioner
`
`argues, because the handle is detachable from controller 31, “power can be
`
`supplied to the motor 45 only when handle 40 is attached to controller 31 via cable
`
`205.”2 Id.
`
`
`2 Petitioner’s combination of Hooven and Heinrich provides no additional support.
`
`Petitioner merely states that “Hooven’s DC motor 45, which is in handle 40, would
`
`22
`
`

`

`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`
`Petitioner misses the mark. While Hooven arguably discloses the limitation
`
`of claim 11—an electric motor that is configured to receive power from a power
`
`supply only when said housing is attached to the surgical instrument—it fails to
`
`disclose all of the limitations of claims 1 and 6. Specifically, Hooven does not
`
`disclose a “motor configured to receive power from a power source” independent
`
`of whether the DLU is attached to the surgical instrument. Furthermore, Petitioner
`
`offers no argument that the missing limitation would have been obvious. This
`
`failure applies equally to claims 1 and 6, and thus the Petition should be rejected
`
`on this ground alone.
`
`B.
`
`Petitioner Does Not Establish A Motivation To Combine Or
`Reasonable Expectation Of Success
`
`In an obviousness ground, it is the Petitioner’s burden to show “that a skilled
`
`artisan would have been motivated to combine the teachings of the prior art
`
`references to achieve the claimed invention, and that the skilled artisan would have
`
`had a reasonable expectation of success in doing so.” Kinetic Concepts, Inc. v.
`
`Smith & Nephew, Inc. 688 F.3d 1342, 1360 (Fed. Cir. 2012). In inter partes
`
`review proceedings, “the standard is not whether the patent owner can persuasively
`
`show that one of ordinary skill would have expected failure.” Honeywell Int'l Inc.
`
`
`be configured to receive power from Heinrich’s surgical instrument system, which
`
`includes a power source.” Petition at 39. This provides no additional detail.
`
`23
`
`

`

`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`v. Mexichem Amanco Holding S.A. De C.V., 865 F.3d 1348, 1355 (Fed. Cir. 2017)
`
`(“Rather, the burden is on the Examiner to show that one of ordinary skill would
`
`have had a motivation to combine the references with a reasonable expectation of
`
`success.”).
`
`Petitioner falls well short of meeting its burden for three reasons. First,
`
`Petitioner provides no explanation for how the surgical systems of Hooven and
`
`Heinrich would be combined. This failure is significant, as the two references
`
`disclose incompatible surgical systems. Second, Petitioner provides no showing of
`
`a reasonable expectation of success. Third, Petitioner’s only proffered motivations
`
`to combine Hooven and Heinrich are hindsight based solely off of the disclosures
`
`of the 058 Patent itself. Each of these failures provides an independent basis to
`
`deny the Petition.
`
`1.
`
`Petitioner provides no explanation for how to combine the
`incompatible systems of Hooven and Heinrich.
`
`Petitioner has provided no cognizable combination of Hooven and Heinrich.
`
`Petitioner’s entire description of the proposed combination is that “a POSITA
`
`would have modified Hooven’s stapling system (i.e., instrument 30) to include
`
`Heinrich’s housing connector… to removably attach Hooven’s instrument 30 to
`
`Heinrich’s surgical instrument system (i.e., actuation assembly 612, monitor 614,
`
`and robot 616) as taught by Heinrich.” Petition at 31; see also Ex. 1004 at Fig. 1;
`
`Ex. 1005 at Fig. 7:
`
`24
`
`

`

`
`
`Hooven
`
`Heinrich
`
`IPR2018-00934
`U.S. Patent No. 8,998,058
`
`
`Petitioner’s cursory description does not logically follow from the
`
`
`
`
`
`disclosures of Hooven and Heinrich. As discussed above, Hooven was directed
`
`toward a surgical instrument system that would provide “improved manipulation
`
`and control of the instrument during the procedure” along with providing “sensing
`
`feedback to the surgeon to compensate for the loss of tactile feedback.” Ex. 1004
`
`at 2:36-42. Hooven accomplished these goals by providing the surgeon a surgical
`
`instrument 30, which has a handle 40 with controls for the surgeon and a flexible
`
`shaf

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