`______________________
`
`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
`IPR2018-00935 – U.S. Patent No. 8,991,677
`______________________
`
`DECLARATION OF DR. WILLIAM CIMINO
`
`
`Ethicon Exhibit 2006.001
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`I.
`QUALIFICATIONS AND COMPENSATION .............................................. 4
`II.
`III. RELEVANT LEGAL STANDARDS ............................................................. 6
`IV. BACKGROUND OF THE TECHNOLOGY .................................................. 7
`V.
`THE POWER PATENTS AND THEIR CLAIMS ....................................... 11
`A. Overview of the Power Patents ........................................................... 11
`B.
`Statutory Disclaimers of Claims 11-15 and 18 of the 677 Patent
`and Claims 11-18 of the 058 Patent .................................................... 18
`The Challenged Claims ....................................................................... 18
`1.
`Overview of the Challenged Independent Claims of the
`677 Patent .................................................................................. 19
`Overview of the Challenged Independent Claims of the
`058 Patent .................................................................................. 21
`VI. CLAIM CONSTRUCTION .......................................................................... 24
`A.
`The 677 Patent ..................................................................................... 24
`1.
`“stapling sub-system comprising: … an electric motor …
`wherein said electric motor is operably disconnected
`from a power source when said housing is not attached to
`the surgical instrument system, and wherein said electric
`motor is operably connected to the power source when
`said housing is attached to the surgical instrument
`system” (Claims 6, 17) .............................................................. 24
`“[disposable] loading unit comprising: … a motor …
`wherein said motor is configured to receive power from a
`power source such that said motor can only selectively
`receive power from said power source when said means
`for removably attaching said housing to the surgical
`instrument is operably coupled to the surgical
`instrument.” (Claims 1, 16) ....................................................... 34
`The 058 Patent ..................................................................................... 42
`1.
`“stapling system comprising … an electric motor …
`configured to receive power from a power source such
`
`2.
`
`2.
`
`C.
`
`B.
`
`
`
`i
`
`Ethicon Exhibit 2006.002
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`that said electrical motor can only selectively receive
`power from said power source when said housing
`connector is attached to the surgical instrument system”
`(Claim 6) / “disposable loading unit comprising: … a
`motor … configured to receive power from a power
`source such that said motor can only selectively receive
`power from said power source when said means for
`removably attaching said housing to the surgical
`instrument is operably coupled to the surgical
`instrument” (Claim 1) ............................................................... 42
`VII. THE PRIOR ART .......................................................................................... 44
`A. Hooven ................................................................................................ 44
`B.
`Heinrich ............................................................................................... 51
`C. Milliman .............................................................................................. 59
`VIII. REASONS WHY CLAIMS 1-10, 16, AND 17 OF THE 677 PATENT
`ARE NOT RENDERED OBVIOUS BY THE PRIOR ART ....................... 62
`A. Hooven In View Of Heinrich Does Not Disclose The Power
`Limitations of the 677 Patent .............................................................. 63
`1.
`677 Patent Claims 6 and 17: Hooven in view of Heinrich
`does not disclose a motor that is “operably connected”
`and “operably disconnected” from an attached power
`source ........................................................................................ 63
`677 Patent Claims 1 and 16: Hooven in view of Heinrich
`does not disclose a motor configured to only selectively
`receive power from an attached power source .......................... 71
`IX. REASONS WHY CLAIMS 1-10 OF THE 058 PATENT ARE NOT
`RENDERED OBVIOUS BY THE PRIOR ART .......................................... 77
`PETITIONER DOES NOT ESTABLISH A MOTIVATION TO
`COMBINE HOOVEN WITH HEINRICH/MILLIMAN .............................. 77
`A. Heinrich and Milliman Discourage Combining Hooven with
`Heinrich ............................................................................................... 78
`A POSITA Would Not Have Had A Reasonable Expectation Of
`Success In Combining Hooven With the Teachings of Heinrich ....... 80
`XI. SUMMARY OF OPINIONS CONCERNING THE DISCLOSURES
`OF HOOVEN AND HEINRICH .................................................................. 84
`
`2.
`
`X.
`
`B.
`
`
`
`ii
`
`Ethicon Exhibit 2006.003
`Intuitive v. Ethicon
`IPR2018-00934
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`
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`XII. JURAT ........................................................................................................... 85
`
`
`
`
`
`
`iii
`
`Ethicon Exhibit 2006.004
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`
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`I, Dr. William Cimino, hereby declare as follows:
`
`1.
`
`I have personal knowledge of the facts stated in this declaration and, if
`
`called upon to do so, could and would attest to these facts under oath.
`
`2.
`
`I make this declaration at the request of Ethicon LLC (“Patent
`
`Owner”), in connection with the petitions for inter partes review submitted by
`
`Intuitive Surgical, Inc. (“Petitioner”) for U.S. Patent Nos. 8,998,058 (“the 058
`
`Patent”) and 8,991,677 (“the 677 Patent”), which I will refer to collectively as the
`
`“Power Patents.” All statements made herein of my own knowledge are true, and
`
`all statements made herein based on information and belief are believed to be true.
`
`Although I am being compensated for my time in preparing this declaration, the
`
`opinions articulated herein are my own, and I have no stake in the outcome of this
`
`proceeding or any related litigation or administrative proceedings.
`
`I.
`
`INTRODUCTION
`3.
`In the preparation of this declaration, I have reviewed the relevant
`
`portions of the following documents:
`
`Ex. 1001 (058
`Patent)1
`
`U.S. Patent No. 8,998,058 to Moore, et al. (“the 058 Patent”)
`
`
`1 I understand that the 058 Patent and the 677 Patent share a common specification
`
`and figures and that both have been provided as Exhibit 1001 in IPR2018-00934
`
`
`
`1
`
`Ethicon Exhibit 2006.005
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ex. 1001 (677
`Patent)
`Ex. 1002
`
`U.S. Patent No. 8,991,677 to Moore, et al. (“the 677 Patent”)
`
`Excerpts from the prosecution histories of U.S. Pat. Nos.
`9,084,601 (Serial No. 13/832,522), 8,998,058 (Serial No.
`14/282,494), 8,991,677 (Serial No. 14/283,729), 8,752,749
`(Serial No. 13/118,210), 8,196,795 (Serial No. 12/856,099),
`and 7,793,812 (Serial No. 12/031,628)
`
`Ex. 1003
`
`Declaration of Dr. Gregory S. Fischer
`
`Ex. 1004
`
`U.S. Patent No. 5,383,880 to Hooven (“Hooven”)
`
`Ex. 1005
`
`U.S. Patent App. Pub. No. 2005/0131390 to Heinrich et al.
`(“Heinrich”)
`
`Ex. 1006
`
`U.S. Patent No. 5,865,361 to Milliman et al. (“Milliman”)
`
`Ex. 1008
`
`U.S. Patent No. 8,196,795 to Moore et al. (“the 795 Patent”)
`
`Ex. 1009
`
`U.S. Patent No. 8,752,749 to Moore et al. (“the 749 Patent”)
`
`Ex. 1010
`
`U.S. Patent No. 5,779,130 to Alesi et al. (“Alesi”)
`
`Ex. 1013
`
`U.S. Patent No. 6,783,524 to Anderson et al. (“the 524
`Patent”)
`
`Ex. 2001
`
`U.S. Patent No. 5,964,394 to Robertson (“Robertson”)
`
`Ex. 2002
`
`U.S. Patent No. 6,231,565 to Tovey et al. (“Tovey”)
`
`Ex. 2007
`
`Deposition of Gregory Fischer, Ph. D., Volume 1 (February
`18, 2019)
`
`
`and IPR2018-00935. I will therefore identify which patent’s specification I am
`
`referring to whenever I cite to Exhibit 1001 in my declaration.
`
`
`
`2
`
`Ethicon Exhibit 2006.006
`Intuitive v. Ethicon
`IPR2018-00934
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`
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`Ex. 2008
`
`Ex. 2012
`
`Deposition of Gregory Fischer, Ph. D., Volume 2 (February
`20, 2019)
`
`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)
`
`4.
`
`The opinions I have formed as explained herein are informed by and
`
`based on my consideration of the documents listed above and those documents
`
`cited herein, as well as my own knowledge and experience based upon my work in
`
`the relevant field of technology, as discussed below.
`
`5.
`
`For my analysis, I am instructed to assume a priority date of February
`
`14, 2008, the same priority date assumed by Petitioner’s consultant Dr. Gregory S.
`
`Fischer. See Ex. 1003, ¶ 2. I am familiar with the technology described in the
`
`Power Patents and am aware of the state of the art around February 14, 2008. I
`
`understand that Dr. Fischer has defined a person of ordinary skill in the art
`
`(“POSITA”) as one who has “the equivalent of a Bachelor’s degree or higher in
`
`mechanical engineering, electrical engineering, biomedical engineering, or a
`
`related field directed towards medical electro-mechanical systems and at least 3
`
`years working experience in research and development for surgical instruments.”
`
`Ex. 1003, ¶ 27. I understand that the Board has applied Dr. Fischer’s definition of a
`
`POSITA in its institution decision. For the purpose of this declaration, I apply this
`
`level of ordinary skill.
`
`
`
`3
`
`Ethicon Exhibit 2006.007
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`6.
`
`As my CV indicates, I held at least the qualifications of a POSITA as
`
`of February 2008. My analyses and opinions herein are given from the perspective
`
`of a POSITA as of February 2008, unless stated otherwise. I am familiar with the
`
`knowledge and experience of a POSITA because of my years of experience
`
`working with such people of such a skill level.
`
`II. QUALIFICATIONS AND COMPENSATION
`7.
`I received a Bachelor of Science degree in Aerospace Engineering
`
`from the University of Colorado in 1983, a Master of Science degree in
`
`Engineering (Mechanical) from Purdue University in 1985, and a Ph.D. degree in
`
`Bioengineering from the University of Utah in 1992.
`
`8.
`
`I have over 30 years of engineering experience, including over 25
`
`years of experience in the research, design, and development of medical surgical
`
`instruments, including ultrasonic surgical instruments for neurosurgery and plastic
`
`surgery, electrosurgical instruments, cardiac catheters, and tissue processing
`
`systems. In addition, I have significant experience in the design and development
`
`of robotic systems.
`
`9.
`
`I am currently CEO of The GID Group (a biotechnology company).
`
`Before that, I was CEO/President of Sound Surgical for about 10 years (an
`
`ultrasonic instrument company). I also worked for five years at Valleylab, Inc.
`
`(Pfizer, U.S. Surgical), where I was directly involved in the design, development,
`
`
`
`4
`
`Ethicon Exhibit 2006.008
`Intuitive v. Ethicon
`IPR2018-00934
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`
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`and evaluation of ultrasonic and electrosurgical instruments for use in fragmenting,
`
`dissecting, and coagulating tissue. I spent four years working on cardiac catheter
`
`design and development, one year at Heart Rhythm Technologies (Eli Lilly) and
`
`three years at the Center for Engineering Design (Utah). I also worked for 4½
`
`years at Boeing Aerospace where I was involved in control system design and
`
`structural interaction analysis. In addition, at Boeing I was responsible for the
`
`design and development of control systems used in connection with robotic arms
`
`systems used in space for interaction with space stations and vehicles. A current
`
`copy of my curriculum vitae is attached as Appendix A.
`
`10.
`
`I have published a number of scientific papers, including a Master’s
`
`degree thesis on kinematic analysis and control of robotic systems. A list of my
`
`publications is included in my CV (Appendix A). I am a named inventor on over
`
`40 U.S. patents, most relating to surgical instruments, and also on several
`
`additional related patents that have issued abroad.
`
`11.
`
`I am being compensated for my time expended in connection with this
`
`matter at the rate of $425 per hour, plus reimbursement of expenses. I have no
`
`financial stake in the outcome of this matter, and my compensation is not
`
`contingent upon the outcome of this matter.
`
`
`
`5
`
`Ethicon Exhibit 2006.009
`Intuitive v. Ethicon
`IPR2018-00934
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`
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`III. RELEVANT LEGAL STANDARDS
`12.
`I have been asked to provide my opinions regarding whether certain
`
`claims of the Power Patents are rendered obvious by the prior art.
`
`13.
`
`I understand that a claimed invention is not patentable under 35
`
`U.S.C. § 103 if the differences between the invention as claimed and the prior art
`
`are such that the subject matter as a whole would have been obvious at the time the
`
`invention was made to a person of ordinary skill in the art. I also understand that an
`
`analysis of obviousness considers the level of ordinary skill in the art, the scope
`
`and content of the prior art, the differences between the prior art and the claimed
`
`subject matter, and any secondary considerations which may suggest that the
`
`claimed invention was not obvious.
`
`14.
`
`I am informed that the courts have recognized several rationales for
`
`combining references or modifying a reference to show the obviousness of claimed
`
`subject matter. I understand these include: combining prior art elements according
`
`to known methods to yield predictable results; the substitution of one known
`
`element for another to obtain predictable results; use of a known technique to
`
`improve a similar device in a known way; applying a known technique to a known
`
`device to yield predictable results; choosing from a finite number of identified,
`
`predictable solutions, with a reasonable expectation of success; and some
`
`motivation in the prior art that would have led a person of ordinary skill in the art
`
`
`
`6
`
`Ethicon Exhibit 2006.010
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`to modify the prior art reference or to combine prior art reference teachings to
`
`arrive at the claimed invention.
`
`15.
`
`I understand through legal counsel that courts have emphasized that a
`
`purported combination of references must include a rationale for a motivation to
`
`combine the references, and further that a person of ordinary skill in the art must
`
`have a had a reasonable expectation of success in making the combination.
`
`IV. BACKGROUND OF THE TECHNOLOGY
`16.
` Minimally invasive surgical procedures incorporate the use of
`
`specialized surgical techniques and tools to gain access to a patient through several
`
`smaller incisions as opposed to one (or more) larger incisions. The associated
`
`benefits are well documented – studies have shown that minimally invasive
`
`surgeries reduce the length of stay and cost for the patient, shorten recovery time,
`
`and result in improvements in operating room efficiency. See Ex. 2012 at Abstract.
`
`17. A commonly used tool in certain types of minimally invasive
`
`procedures is a surgical stapler capable of both cutting and stapling tissue. Referred
`
`to as an endocutter or a linear cutter, these devices include an end effector
`
`comprising a pair of jaws that are configured to grasp and clamp onto tissue within
`
`the body of a patient. Typically, one of the jaws includes a staple cartridge that
`
`holds a plurality of staples, while the other jaw (usually referred to as an anvil) is
`
`
`
`7
`
`Ethicon Exhibit 2006.011
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`articulable to clamp down on tissue and secure it between the jaws. This is
`
`illustrated in the figure below:
`
`
`
`18.
`
`In addition to the staple cartridge, the end effector also includes a
`
`cutting instrument, such as a knife. Once tissue is secured between the jaws, a
`
`driver element traverses the channel in the staple cartridge, driving the staples and
`
`causing them to deform against the anvil to form several rows of staples that
`
`secures the tissue. At the same time, the knife may advance between the rows of
`
`staples to bisect the tissue after it has been secured with the staples.
`
`19. Some of the first endocutters released to market were handheld
`
`instruments that required significant power from the operator to drive the stapling
`
`and cutting actions. This would typically be accomplished through the repeated
`
`
`
`8
`
`Ethicon Exhibit 2006.012
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`retraction of a trigger mechanism to incrementally cause the driver element to
`
`traverse the channel, thus effecting both the stapling and cutting actions. An
`
`example of a so-called unpowered endocutter is illustrated below in Figure 1:
`
`
`
`Ex. 1006 at Fig. 1. The need to provide manual force presented several
`
`disadvantages. For example, differences in tissue thickness could make it more
`
`difficult to achieve a secure cut and staple line in certain procedures. In addition,
`
`repeated retraction of the trigger mechanism to advance the driver element could
`
`introduce unwanted motion at the end effector and produce a faulty cut or damage
`
`tissue. Furthermore, the force required to cut and staple could present a barrier to
`
`entry for surgeons with insufficient grip strength. The introduction of powered
`
`endocutters resolved many of these issues.
`
`
`
`9
`
`Ethicon Exhibit 2006.013
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`20.
`
`In a powered endocutter, an electric motor receives power from a
`
`power source, which it converts to rotational torque to advance the driver element.
`
`This tends to result in a more consistent staple line because the cutting and stapling
`
`actions are performed through a single, smooth advancement of the driver element,
`
`as compared to the multi-stage advancement produced by each retraction of the
`
`trigger in an unpowered endocutter.
`
`21. Powered endocutters may have resolved certain issues associated with
`
`unpowered endocutters, but they also presented unique problems of their own.
`
`Supplying power to an electric motor requires an electrical connection, which is
`
`further complicated by the need to maintain a sterile environment when operating
`
`an endocutter. To promote sterility and because the staples are consumed during
`
`use, the endocutter DLU is typically thrown out after use, whereas the surgical
`
`instrument itself (e.g. the handheld body that the endocutter DLU attaches to) may
`
`continue to be used during a single surgical episode. In order to provide electricity
`
`to the prior-art DLU’s electric motor, electrical contacts are required between the
`
`DLU and its point of attachment to the surgical instrument. .
`
`
`
`10
`
`Ethicon Exhibit 2006.014
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`V. THE POWER PATENTS AND THEIR CLAIMS
`A. Overview of the Power Patents
`22. The Power Patents share a common specification that is identical
`
`other than the summary of the invention. Thus, it should be understood that
`
`specification citations to either the 058 or 677 Patent apply equally to both of them.
`
`23. The Power Patents are directed to a “detachable motor-powered
`
`surgical instrument.” Ex. 1001 (058 Patent) at Abstract, 80:8-81:20. As discussed
`
`further below, the challenged claims are specifically directed to a surgical cutting
`
`and stapling instrument. Unlike prior surgical stapling systems, the Power Patents
`
`describe a system where power is provided to a motor separate from the point of
`
`attachment of the surgical instrument. This distinction is captured in each of the
`
`Power Patents’ challenged claims and provides several benefits over prior cutting
`
`and stapling systems.
`
`24. As the Power Patents disclose, surgical staplers were known in the art,
`
`including surgical stapling tools that were “configured to operate with disposable
`
`loading units (DLU’s).” Id. at 1:54-2:4. When using a DLU, once “the procedure is
`
`completed, the entire DLU is discarded.” Id. at 2:4-5. This reduces the risk of
`
`spreading infections between procedures. The Power Patents identify 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.
`
`
`
`11
`
`Ethicon Exhibit 2006.015
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`25. The disadvantage of those surgical stapling tools was that they lacked
`
`an electric motor to assist with clamping and firing. As the Power Patents explain,
`
`“prior disposable loading units… require[d] the clinician to continuously ratchet
`
`the handle” of the tool in order to operate the device. Id. at 2:12-14. This made it
`
`more difficult for the surgeon to maintain a straight staple line, especially through
`
`particularly thick tissue. Thus, “[t]here [was] a need for a surgical stapling
`
`apparatus configured for use with a disposable loading unit that [was] driven by a
`
`motor contained in the disposable loading unit.” Id. at 2:14-17.
`
`26. Figure 1 of the Power Patents discloses “a disposable loading unit 16
`
`… that is coupled to a conventional surgical cutting and stapling apparatus 10.” Id.
`
`at 10:21-25.
`
`
`
`12
`
`
`
`Ethicon Exhibit 2006.016
`Intuitive v. Ethicon
`IPR2018-00934
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`
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`27. 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 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.
`
`28. Figure 2 provides additional detail of the construction of DLU 16.
`
`Particularly, the DLU includes a motor 562 and an attached power source (battery
`
`526). 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 assembly by drive beam 266. Id. at 10:58-67. 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 11:2-5. This 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.
`
`
`
`13
`
`
`
`Ethicon Exhibit 2006.017
`Intuitive v. Ethicon
`IPR2018-00934
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`
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`29. The configuration of the motor 562 and battery 526 are shown in more
`
`detail in Figure 3. Battery 526 is housed in battery holder 524. Id. at 11:30-33.
`
`There are two battery contacts, 528 and 530. These contacts are “mounted in
`
`electrical contact with the battery 526 and also protrud[ing] out of the battery
`
`holder 524 to slide along the inside wall 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. Inside wall 523 includes 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. As Figure 3 plainly illustrates, the motor 562 receives power from the battery
`
`through a connection that is separate from the attachment of the DLU to the
`
`apparatus (connection 500 and pins 254 in Figure 2). However, attachment of the
`
`DLU to the apparatus is still necessary in order to permit power to be supplied
`
`from the battery to the motor.
`
`
`
`14
`
`Ethicon Exhibit 2006.018
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`
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`30. As the specification explains, once the DLU and apparatus are
`
`
`
`attached “the distal end 276 of the control rod 52 has been coupled to the battery
`
`holder 524.” Id. at 12:40-42. The control rod may then move the battery holder in a
`
`distal direction in response to user input, such that power will be “permitted to
`
`flow from the battery 526 to the motor 562” to operate the surgical stapler. Id. at
`
`12:63-65. This is visually apparent in Figures 7 and 9, which illustrate how
`
`attachment of the DLU to the apparatus permits power to flow for closing and
`
`firing, respectively.
`
`
`
`15
`
`Ethicon Exhibit 2006.019
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
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`
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`
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`
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`
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`
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`permitted to flow to motor
`
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`
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`
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`
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`
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`
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`
`Control rod 52 of
`
`surgical instrument
`system is attached
`to DLU
`
`
`
`Ethicon Exhibit 2006.020
`
`Intuitive v. Ethicon
`
`lPR2018-00934
`
`Ethicon Exhibit 2006.020
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`31. This is also described in the specification text relating to Figures 7 and
`
`9.
`
`As can be seen in FIG. 7, as the control rod 52 is initially moved in the
`distal direction during the anvil close stroke, the battery holder 524
`moves the battery 526 to a position wherein the battery contacts 528,
`530 contact the anvil close contacts 542. Power is now permitted to
`flow from the battery 526 to the motor 562 which rotates the drive
`screw 600 and causes the drive beam 266 to move distally. … When
`the clinician desires to fire the instrument 10 (i.e., actuate the
`instrument 10 to cause it to cut and staple tissue), the clinician first
`depresses the plunger 82 of the firing lockout assembly 80 (FIG. 1) as
`discussed in U.S. Pat. No. 5,865,361. Thereafter, movable handle 24
`may be actuated. As the movable handle 24 is depressed, the control
`rod 52 moves the battery holder 524 and battery 526 to the position
`illustrated in FIGS. 9 and 10. As can be seen in those Figures, when
`the battery 526 is moved into that position, the battery contacts 528,
`530 are brought into contact with the fire contacts 544. The switch 650
`is normally closed until it is actuated by the knife nut 610. Thus, when
`the battery contacts 528, 530 contact the firing contacts 544, power
`flows from the battery 526 to the motor 562 which drives the drive
`screw 600.
`
`Id. at 12:59-13:24.
`
`
`32. The specification explains that this configuration is advantageous
`
`because it “prevent[s] the battery 526 from being drained during non-use.” Id. at
`
`11:54-58.
`
`
`
`17
`
`Ethicon Exhibit 2006.021
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`33. Additionally, patient safety can be improved by avoiding inadvertent
`
`firing of the DLU before it is attached to a system that controls it.
`
`34. The benefits described above can be realized by employing the
`
`claimed inventions of the Power Patents over prior art systems that deliver power
`
`directly through the physical interface between a surgical instrument system and a
`
`DLU.
`
`B.
`Statutory Disclaimers of Claims 11-15 and 18 of the 677 Patent
`and Claims 11-18 of the 058 Patent
`35.
`I understand from counsel that Patent Owner has filed a statutory
`
`disclaimer of claims 11-15 and 18 of the 677 Patent and that as a result of this
`
`statutory disclaimer the institution decision in this proceeding is based only on the
`
`remaining challenged claims 1-10, 16, and 17 of the 677 Patent.
`
`36.
`
`I also understand from counsel that Patent Owner has filed a statutory
`
`disclaimer of claims 11-18 of the 058 Patent and that as a result of this statutory
`
`disclaimer the institution decision in this proceeding is based only on the
`
`remaining challenged claims 1-10 of the 058 Patent.
`
`C. The Challenged Claims
`37. Challenged claims of both of the Power Patents describe embodiments
`
`where the stapler’s motor may only “selectively receive power from the power
`
`source” when the stapler is connected to an apparatus (e.g., a handheld surgical
`
`instrument or a robotic surgical instrument system). See Ex. 1001 (058 Patent) at
`
`
`
`18
`
`Ethicon Exhibit 2006.022
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`2:37-43; Ex. 1001 (677 Patent) at 2:32-42. In addition, some challenged claims of
`
`the 677 Patent also describe an embodiment where the stapler’s motor “is operably
`
`disconnected from a power source” when the stapler is not attached to the
`
`apparatus, and “operably connected to the power source” when the stapler is
`
`attached to the apparatus. See Ex. 1001 (677 Patent) at 2:62–3:3. These
`
`embodiments are illustrated in Figures 3, 7 and 9 – the battery and motor are
`
`operably connected, and 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.
`
`1. Overview of the Challenged Independent Claims of the 677
`Patent
`Independent Claims 6 and 1 of the 677 Patent are representative of the
`
`38.
`
`all of the challenged claims of that patent. These claims are reproduced below.
`
`6. A stapling sub-system configured to be operably engaged with a
`surgical instrument system, said stapling sub-system comprising:
`
`a staple cartridge carrier;
`
`a staple cartridge assembly supported by said staple cartridge
`carrier;
`
`an anvil supported relative to said staple cartridge carrier and
`movable from an open position to a closed position;
`
`
`
`19
`
`Ethicon Exhibit 2006.023
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`a housing, wherein said staple cartridge carrier extends from said
`housing, and wherein said housing comprises a housing connector
`removably attachable to the surgical instrument system; and
`
`a rotary drive system, comprising
`
`a rotary shaft;
`
`a translatable drive member operably engaged with said rotary
`shaft, wherein said translatable drive member is selectively translatable
`through said staple cartridge assembly from a start position to an end
`position when a rotary motion is applied to said rotary shaft; and
`
`an electric motor operably interfacing with said rotary shaft to
`selectively apply said rotary motion to said rotary shaft, wherein said
`electric motor is operably disconnected from a power source when said
`housing is not attached to the surgical instrument system, and wherein
`said electric motor is operably connected to the power source when said
`housing is attached to the surgical instrument system.
`
`677 Patent Claim 6.
`
`
`1. A disposable loading unit configured to be operably attached to a
`surgical instrument which is configured to selectively generate at least
`one control motion for the operation of said disposable loading unit,
`said disposable loading unit comprising:
`
`a carrier operably supporting a cartridge assembly therein;
`
`
`
`20
`
`Ethicon Exhibit 2006.024
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`an anvil supported relative to said carrier and being movable
`from an open position to closed positions upon application of at least
`one control motion thereto;
`
`a housing coupled to said carrier, said housing including means for
`removably attaching said housing to the surgical instrument;
`
`
`
`
`a rotary drive at least partially supported within said housing;
`
`a motor supported within said housing and operably interfacing
`with said rotary drive to selectively apply a rotary motion thereto,
`wherein said motor is configured to receive power from a power source
`such that said motor can only selectively receive power from said power
`source when said means for removably attaching said housing to the
`surgical instrument is operably coupled to the surgical instrument; and
`
`a linear member coupled with said rotary drive which moves
`axially upon the application of a rotary motion thereto from said motor.
`
`677 Patent Claim 1.
`
`
`2. Overview of the Challenged Independent Claims of the 058
`Patent
`Independent Claims 6 and 1 of the 058 Patent are representative of the
`
`39.
`
`challenged claims of that patent. These claims are reproduced below.
`
`6. A stapling system configured to