`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`
`
`IPR2018-01247
`U.S. Patent No. 8,479,969
`______________________
`
`DECLARATION OF DR. ELLIOTT FEGELMAN
`
`
`
`
`
`Ethicon Exhibit 2007.001
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`QUALIFICATIONS AND BACKGROUND ................................................. 1
`
`III. OVERVIEW OF OPEN, TRADITIONAL LAPAROSCOPIC,
`AND ROBOTIC LAPAROSCOPIC SURGICAL
`PROCEDURES ............................................................................................... 3
`
`IV. PASSIVE ARTICULATION WITH ROBOTIC SURGICAL
`TOOLS WOULD NOT HAVE BEEN CLINICALLY
`ACCEPTABLE TO SURGEONS IN THE 2011 TIMEFRAME ................... 9
`
`V.
`
`JURAT ........................................................................................................... 11
`
`
`
`
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`
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`Ethicon Exhibit 2007.002
`Intuitive v. Ethicon
`IPR2018-01247
`
`
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`
`
`I.
`
`INTRODUCTION
`1. My name is Dr. Elliott Fegelman. I have been asked by counsel for
`
`Patent Owner Ethicon LLC (“Patent Owner”) to offer my opinions from the
`
`perspective of a practicing surgeon in connection with the above-captioned
`
`proceeding. I understand from counsel that the 2011 timeframe is the relevant
`
`timeframe for this proceeding, and I was a practicing general surgeon at that time.
`
`2.
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`Unless otherwise stated, the statements in this declaration are based
`
`on my personal knowledge, my experience as a surgeon and hospital administrator
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`for nearly 30 years, and the documents cited in this declaration. I am currently
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`employed by and being compensated by Ethicon Endo-Surgery, Inc. (an affiliate of
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`Patent Owner), but I am not being separately compensated for my time in
`
`preparing this declaration. If called as a witness, I could and would attest to the
`
`statements in this declaration under oath.
`
`II. QUALIFICATIONS AND BACKGROUND
`3.
`I received a Doctor of Medicine degree from Wright State University
`
`in 1988. I then completed my residency in general surgery at the University of
`
`Cincinnati College of Medicine in 1994. After completing my residency, I joined
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`the faculty at the University of Cincinnati as an assistant professor. I continued to
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`be a professor at the University of Cincinnati until 2009.
`
`
`
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`1
`
`Ethicon Exhibit 2007.003
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
`
`4.
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`Starting in 1994, I also was employed at the Christ Hospital in
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`Cincinnati as a general surgeon. I ultimately achieved the position of Chief of
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`Surgery at the Christ Hospital in 2000. I retained that role until July 2002, when I
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`accepted the role of Chief of Surgery at the Jewish Hospital in Cincinnati, Ohio. I
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`retained that position until August 2011.
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`5.
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`Between 1998 and 2012, while in private practice, I consulted for
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`Ethicon Endo-Surgery, Inc. for approximately four hours per week on a variety of
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`surgical matters. In September 2012, I retired from active surgical practice and
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`accepted a full-time role at Ethicon Endo-Surgery, Inc. From 2012 to 2015, I was a
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`medical director in the area of metabolic disease. Starting in 2015, I moved out of
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`that area and now focus on evaluating third-party technologies across the general
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`surgery platform.
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`6.
`
`During my career as a general surgeon, I have performed numerous
`
`open and laparoscopic procedures. During these procedures, I worked extensively
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`with open surgical instruments and hand-held laparoscopic surgical instruments.
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`Examples of laparoscopic surgical instruments that I have used during my career
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`include but are not limited to graspers (forceps), scissors, needle drivers, energy
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`devices, clip appliers, and endocutters.
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`7.
`
`During my career, I also became experienced with robotic surgery
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`systems offered by Intuitive Surgical, Inc. and performed numerous surgeries using
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`
`
`
`2
`
`Ethicon Exhibit 2007.004
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
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`the da Vinci Si surgical system. Examples of robotic laparoscopic surgical
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`instruments that I have used during my career include but are not limited to
`
`graspers (forceps), scissors, needle drivers, energy devices, and clip appliers. At
`
`the time of my retirement, a robotic endocutter was not available.
`
`III. OVERVIEW OF OPEN, TRADITIONAL LAPAROSCOPIC, AND
`ROBOTIC LAPAROSCOPIC SURGICAL PROCEDURES
`8.
`I will start with a general overview of relevant aspects of open,
`
`traditional laparoscopic,1 and robotic laparoscopic surgical procedures.
`
`9.
`
`In an open procedure, a large incision gives the surgeon direct access
`
`to the surgical site. This is illustrated below:
`
`
`Ex. 2001.006 (Excerpts from Ethicon’s Technology Tutorial)
`
`
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`1 By “traditional,” I am referring to laparoscopic procedures that do not involve
`
`robotic systems.
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`
`
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`3
`
`Ethicon Exhibit 2007.005
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
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`10.
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`In contrast, traditional laparoscopic and robotic laparoscopic (i.e.,
`
`“minimally invasive”) procedures involve several smaller incisions. Devices called
`
`trocars (or cannulas)2 are inserted through the incisions, which provide a pathway
`
`to the surgical site. Hand-held or robotic laparoscopic surgical tools are then
`
`inserted through this pathway. A traditional laparoscopic procedure using hand-
`
`held laparoscopic surgical tools is illustrated below. In the illustration, hand-held
`
`laparoscopic surgical tools have been inserted through trocars and the surgeon is
`
`viewing the surgical site on video:
`
`
`Ex. 2001.007 (Excerpts from Ethicon’s Technology Tutorial)
`
`
`
`2 I will use the term trocars in this declaration to refer to both trocars and cannulas,
`
`which I consider interchangeable.
`
`
`
`
`4
`
`Ethicon Exhibit 2007.006
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
`
`11. Because the incisions are small in laparoscopic procedures,
`
`laparoscopic surgical tools typically have a narrow shaft that fits through the trocar
`
`pathway. The portion of the instrument that engages tissue (i.e., the end effector) is
`
`at the end of the shaft that reaches the surgical site.
`
`12. The narrow trocar pathway restricts movement of the shaft of
`
`laparoscopic surgical tools. However, it may be necessary to approach tissue from
`
`multiple different angles. Thus, it may be desirable to move the end effector with
`
`respect to the shaft to change the angle of the end effector with respect to the
`
`tissue. This is also called articulation.
`
`13.
`
`I will elaborate on the operation of endocutter tools to provide an
`
`example of articulation. Endocutters are laparoscopic surgical tools that include an
`
`end effector with stapler jaws. An Ethicon hand-held endocutter is shown below:
`
`
`Ex. 2001.010 (Excerpts from Ethicon’s Technology Tutorial)
`
`5
`
`
`
`
`
`
`Ethicon Exhibit 2007.007
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
`
`14. When an endocutter is fired, a sled translates through the endocutter’s
`
`end effector and drives staples upwards through clamped tissue on opposite sides
`
`of a knife that trails the sled and cuts the tissue. This is illustrated below:
`
`
`Ex. 2001.012 (Excerpts from Ethicon’s Technology Tutorial)
`
`15. Endocutters are used in a variety of procedures, including, for
`
`example, thoracic, bariatric, and colorectal surgeries. These surgeries involve
`
`cutting and stapling tissue.
`
`16. An example of articulating an endocutter end effector from side-to-
`
`side (also called yaw motion) is illustrated below:
`
`
`
`
`6
`
`Ethicon Exhibit 2007.008
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
`
`
`Ex. 2001.011 (Excerpts from Ethicon’s Technology Tutorial)
`
`17. Articulation may be passive or active. Surgical tools that include
`
`passive articulation require external forces to articulate. In other words, passive
`
`articulation requires pressing the exterior of the end effector against another
`
`surgical instrument or structure in the body to articulate the end effector. The
`
`surgeon then locks the end effector in place.
`
`18. Active articulation refers to devices that allow the surgeon to control
`
`articulation without external forces. For example, actively articulated hand-held
`
`laparoscopic surgical tools typically include knobs, buttons, levers, etc. that the
`
`surgeon can operate to articulate the end effector.
`
`19. Because passive articulation brings the end effector into contact with
`
`other structures, passive articulation requires nearly instantaneous, tactile feedback
`
`to ensure that excessive forces are not applied to the structures. This is particularly
`
`
`
`
`7
`
`Ethicon Exhibit 2007.009
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
`
`true when the exterior of the end effector is being pressed against a structure in the
`
`body. With hand-held laparoscopic devices, the surgeon’s grip on the hand-held
`
`portion (which is connected to the end effector through the shaft of the instrument)
`
`provides this tactile feedback. The surgeon also views the surgical site on video;
`
`however, the video does not provide an indication of the forces that are being
`
`applied. Thus, the tactile feedback provided through the surgeon’s grip on the
`
`hand-held portion is critical to the use of passive articulation.
`
`20.
`
`In contrast to hand-held laparoscopic surgical tools, robotic
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`laparoscopic surgical tools are mounted onto an instrument arm of the robotic
`
`system. The surgeon operates the tools remotely from a surgeon console and does
`
`not directly interface with them. This is illustrated below:
`
`
`Ex. 2008.001 (Excerpts from Ethicon’s Technology Tutorial)
`
`
`
`
`
`8
`
`Ethicon Exhibit 2007.010
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
`
`21. Based on my experience using robotic surgical platforms, to the extent
`
`robotic tools could articulate, they were actively articulated by the surgeon at the
`
`console. I am not aware of any passively articulated robotic surgical tools at the
`
`time of my retirement in 2012 nor am I aware of any that exist today.
`
`IV. PASSIVE ARTICULATION WITH ROBOTIC SURGICAL TOOLS
`WOULD NOT HAVE BEEN CLINICALLY ACCEPTABLE TO
`SURGEONS IN THE 2011 TIMEFRAME
`22. As noted above, passive articulation requires pressing the exterior of
`
`the end effector against another structure to articulate the end effector. Performing
`
`passive articulation requires real-time, tactile feedback—and the ability to adapt to
`
`that feedback quickly—to prevent damage to both the surgical tool itself as well as
`
`the structure that is providing the articulation force. In hand-held devices, the
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`surgeon has real-time, tactile feedback because the surgeon is holding the device
`
`and feels it press against another structure. The surgeon also has the ability to make
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`nearly instantaneous decisions based on the tactile feedback.
`
`23.
`
`In the 2011 timeframe, robotic systems did not provide a surgeon with
`
`any type of tactile feedback relating to forces applied to the exterior of the end
`
`effector. Moreover, robotic laparoscopic surgical systems available at this time did
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`not provide haptic feedback relating to forces applied by gripping tools when
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`gripping tissue. See also, e.g., Ex. 2009 at 523, Mucksavage et al., Differences in
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`Grip Forces Among Various Robotic Instruments and da Vinci Surgical Platforms,
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`
`
`
`9
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`Ethicon Exhibit 2007.011
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`
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`Journal Of Endourology, Vol. 25, No. 3 (March 2011) (“Due to the lack of haptic
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`feedback, visual cues are necessary to estimate grip forces and tissue tensions
`
`during surgery.”); id. at 526 (“The current robotic platforms do not employ the use
`
`of haptic feedback.”); id. at 527 (“Although the current technology may be limited
`
`by the lack of direct haptic feedback, this study is the first to establish direct forces
`
`exerted by the robotic instruments.”).
`
`24. Some sort of haptic or other tactile feedback would be necessary in
`
`order to perform passive articulation with a robotic tool safely and effectively.
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`Although video of the surgical site is available, this would not be an acceptable
`
`substitute for tactile feedback for the same reasons that video feedback is not an
`
`acceptable substitute during a traditional laparoscopic procedure. In particular, a
`
`robotic surgeon would have found video feedback alone to be unacceptable when
`
`performing passive articulation because the video does not provide an indication of
`
`the forces being applied.
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`25. Further, from a surgeon’s perspective in the 2011 timeframe, one of
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`the key perceived benefits of a robotic tool was the ability to have complete control
`
`over the movement of the tool from the surgeon console. Passive articulation
`
`relinquishes this control and instead requires external forces to control the
`
`movement of the tool. As a result, passive articulation would negate this key
`
`perceived benefit of robotic surgery tools.
`
`
`
`
`10
`
`Ethicon Exhibit 2007.012
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`
`26.
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`Thus, based on my surgical experience and the discussion above, it is
`
`my opinion that a surgeon would have found a robotic tool with passive
`
`articulation to be clinically unacceptable in the 2011 timeframe.
`
`V. JURAT
`27.
`I declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true;
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`and further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of Title 18 of the United States Code.
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`28.
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`I declare under penalty of perjury that the foregoing is true and correct
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`to the best of my knowledge.
`
`Executed on April 19, 2019
`
`11
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`Ethicon Exhibit 2007.013
`Intuitive v. Ethicon
`IPR2018-01247
`
`
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