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’S REPLY IN SUPPORT OF ITS CONTINGENT
`MOTION TO AMEND UNDER 37 C.F.R. § 42.121
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`______________________
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`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’S REPLY IN SUPPORT OF ITS CONTINGENT
`MOTION TO AMEND UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
`
`
`I.
`II.
`
`V.
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`
`INTRODUCTION ........................................................................................... 1
`THE SUBSTITUTE CLAIMS DO NOT INTRODUCE NEW
`MATTER ......................................................................................................... 2
`III. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO
`COMBINE HEINRICH WITH VIOLA .......................................................... 5
`IV. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO
`COMBINE HEINRICH WITH VIOLA AND YOUNG .............................. 11
`CONCLUSION .............................................................................................. 12
`
`i
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`
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Metalcraft of Mayville, Inc. v. The Toro Company,
`848 F.3d 1358 (Fed. Cir. 2017) ............................................................................ 8
`Other Authorities
`37 C.F.R. § 42.24(a) ................................................................................................. 13
`37 C.F.R. § 42.24(d) ................................................................................................ 13
`37 C.F.R. § 42.121 ............................................................................................. 13, 14
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`
`
`ii
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`
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`Exhibit
`Ex. 2001
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`Ex. 2002
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`Ex. 2003
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`Ex. 2004
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`Ex. 2005
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`Ex. 2006
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`Ex. 2007
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`Ex. 2008
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`Ex. 2009
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`Ex. 2010
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`LIST OF EXHIBITS
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`Description
`U.S. Patent No. 5,964,394 (“Robertson”)
`
`U.S. Patent No. 6,231,565 (“Tovey”)
`
`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).
`
`Statutory Disclaimer
`
`Excerpts from the File History of U.S. Patent No. 8,991,677
`
`Declaration of Dr. William Cimino
`
`Deposition of Gregory Fischer, Ph. D., Volume 1 (February
`18, 2019)
`
`Deposition of Gregory Fischer, Ph. D., Volume 2 (February
`20, 2019)
`
`U.S. Pat. Appl. Pub. 2014/0252071 A1 (application
`publication of U.S. Appl. No. 14,283,729) (“the 729
`Application”)
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`U.S. Pat. App. Pub. 2009/0206136 A1 (application
`publication of U.S. Appl. No. 12/031,628) (“the 628
`Application”)
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`Ex. 2011
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`Reserved
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`Ex. 2012
`
`Robert Glasgow et al., The Benefits of a Dedicated Minimally
`Invasive Surgery Program to Academic General Surgery
`Practice, Journal of Gastrointestinal Surgery, 869-73 (Nov.
`2004)
`
`Ex. 2013
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`Reserved
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`iii
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`
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`Exhibit
`Ex. 2014
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`Ex. 2015
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`Ex. 2016
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`Description
`Supplemental Declaration of Dr. William Cimino
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`Excerpts of American Heritage College Dictionary 3d (1993)
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`Deposition Transcript of Dr. Gregory Fischer (July 11, 2019)
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`iv
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`
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`I.
`
`INTRODUCTION
`Petitioner’s opposition to Patent Owner’s contingent motion to amend is
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`based on two primary arguments, both of which should be rejected.
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`First, Petitioner contends that the substitute claims introduce new matter.
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`This argument is based entirely on the incorrect assumption that the phrase “motor
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`configured for attachment to a power source” is limited to an electrical attachment.
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`This assumption is contrary to the plain meaning of “attachment,” the specification
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`of the 677 Patent, the asserted prior art, and Dr. Fischer’s testimony. The
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`fundamental premise of Petitioner’s argument is flawed, and its argument must
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`fail.
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`Second, Petitioner argues that the substitute claims are obvious over the
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`combinations of Viola and Heinrich, and Viola, Heinrich, and Young. Petitioner’s
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`proposed obviousness combinations are redundant and overly complex. Petitioner
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`argues that a POSITA would use the motor of Heinrich, not to drive a surgical
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`instrument as intended, but to connect a second motor to a second power source
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`from Viola in order to drive a surgical instrument. A POSITA would not have
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`been motivated to make the Rube-Goldberg combination that Petitioner has
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`proposed in order to arrive at the claimed invention.
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`
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`1
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`
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`II. THE SUBSTITUTE CLAIMS DO NOT INTRODUCE NEW MATTER
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`First, Petitioner argues that the following limitation introduces new matter:
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`“said motor is configured to receive power from for attachment to a power source
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`independent of said housing connector attachment to the surgical instrument
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`system.” Paper 21 at 2. Petitioner’s argument is based solely on the incorrect
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`assumption that a motor and power source must be electrically attached to be
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`“attached.” This is contrary to the meaning of “attached.” Based on this faulty
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`definition, Petitioner argues that the 677 Patent teaches only that the motor’s
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`attachment to the power source is dependent on whether the housing connector is
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`attached to the surgical instrument system. Id., 2-3.
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`As explained in the contingent motion to amend and again below, the 677
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`Patent teaches a motor that is physically (but not electrically) attached to a power
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`source independent of whether the housing connector is attached to the surgical
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`instrument system. To be attached to the power source, the motor must simply be
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`connected to the power source – this may be physical or electrical. Ex. 2015 at 3
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`(defining “attached” as “1. To fasten, secure, or join. 2. To connect as an adjunct or
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`associated condition or part.”); see also Ex. 2014, ¶¶ 25-30. Nothing in the plain
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`meaning of “attached’ requires an electrical connection between devices.
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`This plain meaning is consistent with the use of the term “attached” in the
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`677 Patent, the Viola reference, and by Dr. Fischer. The 677 Patent is clear that
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`2
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`attaching does not require an “electrical” attachment. For example, the 677 Patent
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`uses the term “attached” to describe a physical connection between the surgical
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`instrument’s control rod and the housing’s battery holder. See Ex. 1001 at 13:8-10
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`(explaining that “battery holder 524 is moved in the distal direction” when “the
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`control rod 52 is attached to the battery holder 524”). Numerous other examples of
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`attachments as physical connections are described in the specification. See e.g.,
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`Ex. 1001 at 19:49-52 (“surgical end effector 2012 is attached to the tool mounting
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`portion 1300 by an elongated shaft assembly 2008”); 22:11-13 (“spine mounting
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`bracket 2057 attached to the tool mounting plate 1032”); 22:17-18 (“the distal end
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`2202 of the knife bar 200 is attached to the cutting instrument 2032”). Similarly,
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`Viola, the prior art relied upon by Petitioner, uses “attachment” to refer to physical
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`rather than electrical connections. Ex. 1031 at 7:48-52 (referring to a physical
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`“attachment” of the cartridge assembly). Petitioner’s expert even acknowledged
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`that attachment is not limited to an electrical attachment and can also encompass
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`“mechanical coupling.” Ex. 2016, 78:20-22. Petitioner’s assumption that
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`“attachment” requires an electrical attachment or connection is clearly inconsistent
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`with how the term is used in the 677 Patent and in the art.
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`When “attachment” is properly construed to include a physical attachment, it
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`is clear that the amended claims do not introduce new matter. The 677 Patent
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`plainly teaches that the motor is physically connected to the power source
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`3
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`independent of whether the housing connector is attached to the surgical
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`instrument system. This is illustrated, for example, in Figure 3 below. The power
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`source 526 (shown in red) is attached to battery holder 524 (shown in orange),
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`which is in physical contact with the switch portion 520 of the housing connector
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`200 (shown in blue), which is also in physical contact with the motor (shown in
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`yellow). Ex. 1001 at 11:62-12:24. Figure 3 further shows that this is true even
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`when the housing connector is not attached to the surgical system (14).
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`Ex. 1001, Figure 3 (annotated)
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`Thus, Patent Owner’s proposed amendments do not introduce new matter because
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`the 677 Patent discloses a motor that is attached to the power source independent
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`of whether the housing connector is attached to the surgical instrument system.
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`See Ex. 2014, ¶¶ 31-36.
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`4
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`
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`III. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO COMBINE
`HEINRICH WITH VIOLA
`Petitioner next argues that the substitute claims are obvious over Viola in
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`
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`view of Heinrich based on the assertion that a POSITA would have been motivated
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`to take Viola’s large batteries, motor, and other internal components, and somehow
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`insert them into Heinrich’s disposable loading unit (“DLU”). Paper 21 at 3-8.
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`Petitioner further claims that a POSITA would have used Heinrich’s original
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`motor, which Dr. Fischer testified is capable of operating the surgical instrument,
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`solely for controlling a switch bar to connect Viola’s motor to the additional
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`batteries. See Paper 21 at 12; Ex. 2016, 133:15-134:2. A POSITA, however,
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`would not have combined the references in this way because Heinrich’s DLU
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`already contains a motor that is connected to an external power source, and there
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`would be no reason for a POSITA to create the Rube-Goldberg type device
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`contemplated by Petitioner. See Ex. 2014, ¶¶ 47-51.
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`Heinrich discloses that it provides an electrical connection “between slots
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`635 and protrusions 638 in order to provide power to electro-mechanical assembly
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`619” from the power source in the surgical instrument system. Ex. 1005, ¶ 134.
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`As Petitioner’s expert Dr. Fischer explains, electro-mechanical assembly 619 is a
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`motor for driving the attached surgical tools. See Ex. 1003, ¶¶114-15; Ex. 2016,
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`131:1-134:2; Ex. 2014, ¶¶ 40-42. Moreover, Petitioner expressly argues—in this
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`5
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`IPR proceeding—that Heinrich’s motor could “generate the forces required to
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`effectively cut and fasten tissue.” Paper 20 at 21.
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`Despite the fact that Heinrich already discloses a motor in its housing
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`capable of driving an attached surgical tool for cutting and fastening tissue, such as
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`Viola’s staple cartridge 16, Petitioner proposes further adding Viola’s motor and
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`battery into Heinrich’s DLU. See Ex. 1030, ¶ 41 (“it would have been obvious to
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`… incorporate the components inside Viola’s handle 12 (e.g., its motor 22 and
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`power cells 45a-b) into Heinrich’s housing”). Petitioner then argues that a
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`POSITA would have been motivated to “replace or actuate Viola’s trigger 44 with
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`Heinrich’s electromechanical assembly 619” – i.e., to use Heinrich’s motor for the
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`sole purpose of activating Viola’s motor. See Paper 21 at 4; Ex. 1030, ¶ 41. As
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`Dr. Fischer testified, rather than simply attaching Viola’s loading unit to the
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`existing motor of Heinrich, he and Petitioner are proposing “a loading unit attached
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`to a loading unit,” which is then attached to Heinrich’s robotic system. Ex. 2016,
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`150:8-151:1.
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`Petitioner’s proposed combination makes no sense. There is no reason to
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`combine a first loading unit, which contains a motor and power source, to a second
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`loading unit, which contains a second motor, to a robotic system, which contains a
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`second power source. Petitioner’s proposed combination results in a redundant,
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`over-powered motor used solely to control power to a different motor, which is
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`6
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`used to perform the same task the first motor was intended to perform. This
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`combination results in a Rube-Goldberg Machine that no POSITA would have ever
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`been motivated to create. See Ex. 2014, ¶¶ 47-51.
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`Petitioner vaguely argues that combining Viola and Heinrich as described
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`would be desirable as a method to convert a hand-held device to a robotic device,
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`and that the combination would result in cost savings and “manufacturing
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`convenience.” Paper 21 at 7. Petitioner’s argument is based on a generic
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`statement in a different patent that original equipment manufacturer (“OEM”) parts
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`may be used from handheld instruments in conjunction with robotic systems “to
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`reduce costs and for manufacturing convenience.” Id. Regardless of whether or
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`not that might be true in some circumstances, it clearly is not true for Petitioner’s
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`proposed combination. See Ex. 2014, ¶¶ 52-54.
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`It does not follow that incorporating a first DLU with a motor and power
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`source onto a second DLU with its own motor and power source would reduce
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`costs or simplify manufacturing. Id. As Dr. Cimino explains, the components
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`Petitioner suggests should be added to the DLU of Heinrich—Viola’s motor and
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`power cells—are some of the most expensive components in this type of surgical
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`instrument. Id., ¶ 52. At most, if a POSITA were motivated to use OEM parts
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`with the robotic system of Heinrich, it would only be to use a staple cartridge with
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`Heinrich’s DLU and motor. Id., ¶¶ 53-54. Notably, these are the exact types of
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`7
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`
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`embodiments disclosed in Heinrich. See e.g., Paper 2 at 31-32; Ex. 1005, Figs. 1,
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`5, 6, 9, 10, 11. There is no scenario where it would be less expensive to
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`completely re-design Heinrich’s DLU to incorporate additional redundant
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`components. See Ex. 2014, ¶¶ 52-55. No POSITA looking to use OEM parts to
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`reduce costs or simplify manufacturing would seek to make the overly complicated
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`combination Petitioner suggests. Id.
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`This combination is wasteful, costly, technically complex, and defies basic
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`logic, begging the question why a POSITA would have been motivated to make
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`such a combination. Here, the only explicable motivation is to try and stitch
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`together limitations in multiple references to attempt to invalidate the substitute
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`claims. Such hindsight bias, however, is improper. See, e.g., Metalcraft of
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`Mayville, Inc. v. The Toro Company, 848 F.3d 1358, 1367 (Fed. Cir. 2017)
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`(affirming district court’s finding that there would not have been a motivation to
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`combine, explaining that the court “cannot allow hindsight bias to be the thread
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`that stitches together prior art patches into something that is the claimed
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`invention.”) (internal citation omitted).
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`
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`Finally, combining Viola and Heinrich as proposed by Petitioner would have
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`posed technical challenges that would have been beyond the skill level of a
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`POSITA. See Ex. 2014, ¶¶ 56-66; see also Ex. 1003, ¶ 27. Specifically,
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`incorporating two motors and two power sources into the DLU of Heinrich would
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`8
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`
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`have been incredibly technically challenging. See Ex. 2014, ¶¶ 56-66. Heinrich’s
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`DLU already contains a motor and other internal components necessary for
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`converting the motor’s power into a driving force to operate a surgical instrument.
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`Id. Laparoscopic tools operate in small spaces and are therefore designed to be no
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`larger than absolutely necessary to house the functional components that are
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`required to operate the tools. Id., ¶ 58. As a result, Heinrich’s DLU is designed to
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`fit the components necessary to operate Heinrich’s DLU and nothing more - there
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`is simply no additional space to add Viola’s motor, batteries, and additional
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`components that Petitioner identifies. Id.
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`Notably, Petitioner oversimplifies the challenges in combining Viola and
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`Heinrich to minimize the technical challenges involved. Petitioner highlights only
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`the housing, motor, and batteries as the components that would be added to the
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`DLU of Heinrich. Paper 21 at 3-4. The actual combination of Viola and Heinrich
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`would actually require far more. As Dr. Cimino explains, a POSITA would have
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`to combine at a minimum the switching assembly 46, link bar 48, gear set 24, and
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`axial drive beam, as highlighted below. Ex. 2014, ¶ 59.
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`9
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`
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`IPR2018-00935, Paper 21 at 4 (Viola Fig. 2a, annotated)
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`In short, Petitioner proposes cramming almost all of Viola’s surgical instrument
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`into the DLU of Heinrich. Id. Incorporating Heinrich’s first motor is already a
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`challenging technical feat – adding numerous additional components would require
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`a complete redesign of Heinrich’s DLU from the ground up in order to house all
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`the components Petitioner proposes including. Id.
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`Despite the complicated nature of the proposed combination of Viola and
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`Heinrich, and the technical challenges in making the combination, neither
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`Petitioner nor Dr. Fischer provides any guidance on how the combination would be
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`made. See e.g., Paper 21 at 5-8; Ex. 1030, ¶¶ 41-50. Notably, Dr. Fischer testified
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`that he “doesn’t specifically say which elements of Viola’s instrument would be
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`10
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`
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`within the housing or not within the housing.” Ex. 2016 123:16-125:5. Dr.
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`Fischer didn’t propose any specific combination or analyze the technical
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`challenges in making the combination. In his own words: “What I’m saying is, it
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`would have been obvious to take some or all of Viola’s instrument and actuate or
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`control it using Heinrich’s robotic system.” Id., 125:1-5 (emphasis added). Dr.
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`Fischer offered no evidence or reasoning to support this opinion.
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`Neither Petitioner nor Dr. Fischer has defined exactly what from Viola
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`might be combined with Heinrich, much less shown that a POSITA would have
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`had a reasonable expectation of success in the combination. Instead of employing
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`Petitioner’s poorly defined and overly complicated solution, a POSITA would have
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`just used Heinrich as-is, and would have seen no reason to go through the great
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`lengths necessary to include Viola’s motor, batteries, and additional components in
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`Heinrich’s DLU.
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`IV. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO COMBINE
`HEINRICH WITH VIOLA AND YOUNG
`A POSITA would not have been motivated to combine Heinrich with Viola
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`
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`and Young for the same reasons described above with respect to the combination
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`of Heinrich and Viola. See Ex. 2014, ¶¶ 67-69.
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`11
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`
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`V. CONCLUSION
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`For the foregoing reasons, should any of claims 1-5 and 16 be determined to
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`be unpatentable, Patent Owner respectfully requests that the Board grant its
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`contingent motion and amend the 677 Patent to include the substitute claims.
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`Dated: July 19, 2019
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`
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`Respectfully submitted,
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`
`
`
`
`/Anish R. Desai/
`Anish R. Desai
`Reg. No. 73,760
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`E: anish.desai@weil.com
`
`
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`12
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`
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`CERTIFICATE OF COMPLIANCE
`Pursuant to 37 C.F.R. § 42.24(d), the undersigned certifies that the
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`
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`foregoing PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION
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`TO AMEND UNDER 37 C.F.R. § 42.121, contains no more than 12 pages and
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`therefore complies with the limitations of 37 C.F.R. § 42.24(a).
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`
`
`
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`Respectfully submitted,
`
`/Anish R. Desai
`Anish R. Desai
`Reg. No. 73,760
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`E: anish.desai@weil.com
`
`
`
`
`
`Dated: July 19, 2019
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`13
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`
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`CERTIFICATE OF SERVICE
`I hereby certify that on July 19, 2019, a copy of PATENT OWNER’S
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`REPLY IN SUPPORT OF ITS MOTION TO AMEND UNDER 37 C.F.R. §
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`42.121 and any accompanying exhibits were served by filing the documents
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`through the PTAB’s E2E Filing System as well as delivering a copy via electronic
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`mail upon the following:
`
`
`John C. Phillips
`Ryan P. O’Connor
`Steven R. Katz
`FISH & RICHARDSON
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`phillips@fr.com
`oconnor@fr.com
`katz@fr.com
`
`IPR11030-0049IP3@fr.com
`PTABInbound@fr.com
`
`
`
`
`
`/Timothy J. Andersen/
`Timothy J. Andersen
`Case Manager
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, DC 20036
`T: 202-682-7075
`E: timothy.andersen@weil.com
`
`14
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