UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`ETHICON LLC,
`Patent Owner
`
`IPR2018-01248
`U.S. Patent No. 8,479,969
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`
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`DECLARATION OF DR. SHORYA AWTAR
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`Ethicon Exhibit 2021.001
`Intuitive v. Ethicon
`IPR2018-01248
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`ETHICON LLC,
`Patent Owner
`
`IPR2018-01248
`U.S. Patent No. 8,479,969
`
`
`
`
`
`DECLARATION OF DR. SHORYA AWTAR
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`
`
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`
`Ethicon Exhibit 2021.001
`Intuitive v. Ethicon
`IPR2018-01248
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`I.
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`II.
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION .......................................................................................... 1
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`PRIORITY DATE AND LEVEL OF ORDINARY SKILL IN THE
`ART ................................................................................................................. 2
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`III. QUALIFICATIONS ........................................................................................ 3
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`IV. RELEVANT LEGAL STANDARDS ............................................................. 4
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`V. OVERVIEW OF THE TECHNOLOGY DISCLOSED IN THE 969
`PATENT .......................................................................................................... 6
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`VI. PROSECUTION HISTORY OF THE 969 PATENT ................................... 17
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`VII. CLAIM CONSTRUCTION .......................................................................... 17
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`VIII. OVERVIEW OF THE PRIOR ART CITED BY PETITIONER ................. 18
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`A.
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`Ex. 1006, Prisco (U.S. Patent No. 8,545,515) ..................................... 18
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`1.
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`2.
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`Prisco Discloses Cable “Pull-Pull” and Drive Rod “Push-
`Pull” Grip Mechanisms, Which Are Two Distinct Grip
`Mechanisms .............................................................................. 26
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`Prisco’s Shaft Roll Mechanism Does Not Apply a Control
`Motion to a Selectively Movable Component of the End
`Effector ...................................................................................... 31
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`Ex. 1007, Cooper (U.S. Patent No. 6,817,974) ................................... 33
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`Ex. 1008, Wallace (U.S. Patent No. 6,699,235) ................................. 42
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`Ex. 1009, Tierney (U.S. Patent No. 6,331,181) .................................. 45
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`B.
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`C.
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`D.
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`IX. PETITIONER HAS NOT DEMONSTRATED THAT PRISCO
`ANTICIPATES CLAIMS 24-26 OR THAT PRISCO IN
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`i
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`Ethicon Exhibit 2021.002
`Intuitive v. Ethicon
`IPR2018-01248
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`COMBINATION WITH ANY OF THE REMAINING PRIOR ART
`REFERENCES RENDERS OBVIOUS CLAIMS 24-26 ............................. 47
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`A.
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`Petitioner Has Not Demonstrated That Prisco Discloses All
`Limitations Of Claims 24-26, Arranged As In The Claim, and a
`POSITA Would Not Have At Once Envisioned Such An
`Arrangement (Ground 1) ..................................................................... 49
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`1.
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`2.
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`Petitioner’s First Alternative Fails Because Prisco Does
`Not Disclose Combining the Drive Rod “Push-Pull”
`Embodiment With Cooper’s Articulating Wrist
`Mechanism ................................................................................ 51
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`Petitioner’s Second Alternative Relying On Shaft Roll
`Gear 742 Fails Because It Does Not Disclose The Claimed
`Gear-Driven Portion In Operable Communication With A
`Selectively Movable Component And Associated
`Transmission Assembly ............................................................ 60
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`B.
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`Petitioner Has Not Demonstrated That Prisco in View of Cooper,
`Tierney, or Wallace Renders the Challenged Claims Obvious
`(Grounds 2-4) ...................................................................................... 62
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`X.
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`JURAT ........................................................................................................... 68
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`ii
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`Ethicon Exhibit 2021.003
`Intuitive v. Ethicon
`IPR2018-01248
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`I.
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`INTRODUCTION
`1. My name is Dr. Shorya Awtar. I have been retained by counsel for
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`Patent Owner Ethicon LLC (“Ethicon”) in the above captioned inter partes review
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`to consult with counsel, review documents, form opinions, prepare expert
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`declarations, and be available to testify as to my opinions.
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`2.
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`I understand that Petitioner Intuitive Surgical, Inc. (“Intuitive”) has
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`asserted that claims 24-26 of U.S. Patent No. 8,479,969 (the “969 Patent”) are
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`invalid as obvious. I have been asked to give expert opinions and testimony related
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`to the issue of the validity of claims 24-26 of the 969 Patent,1 including the
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`background of the technology at issue, and the scope and content of the prior art.
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`3. My opinions are based on reviewing the Petition, Dr. Knodel’s
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`declaration (Ex. 1003), the Patent Owner Response, the transcripts of Dr. Knodel’s
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`depositions, and the relevant portions of all exhibits cited in any of the foregoing
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`documents and this declaration.
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`4.
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`The opinions I have formed as explained herein are informed by and
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`based on my consideration of the documents listed above, as well as my own
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`knowledge and experience based upon my work in the relevant field of technology,
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`1 I understand that challenged claim 23, which relates to Petitioner’s Grounds 1-3,
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`has been disclaimed. See Ex. 2002.
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`1
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`Ethicon Exhibit 2021.004
`Intuitive v. Ethicon
`IPR2018-01248
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`as discussed below. All statements made herein of my own knowledge are true,
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`and all statements made herein based on information and belief are believed to be
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`true. Although I am being compensated for my time in preparing this declaration,
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`the opinions articulated herein are my own, and I have no stake in the outcome of
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`this proceeding or any related litigation or administrative proceedings. My study is
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`ongoing, and I may supplement or amend these opinions based on the production
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`of additional evidence, as a result of further analysis, or in rebuttal to positions
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`subsequently taken by Intuitive and/or Dr. Knodel.
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`II.
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`PRIORITY DATE AND LEVEL OF ORDINARY SKILL IN THE ART
`5.
`I have been asked to assume that the priority date of the claims of the
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`969 Patent is May 27, 2011. I understand that Intuitive’s expert, Dr. Knodel, has
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`also utilized a priority date of May 27, 2011 in his analysis. See Ex. 1003 at ¶¶ 29-
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`31. I reserve the right to address the priority date of the claims of the 969 Patent
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`should Intuitive subsequently contest this issue.
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`6.
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`I understand that Dr. Knodel has opined that a person of ordinary skill
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`in the art for the 969 Patent would include someone who had the equivalent of a
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`Bachelor’s degree or higher in mechanical engineering with at least 3 years
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`working experience in the design of comparable surgical devices. Ex. 1003 at ¶¶
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`25-26. While I generally agree with the level of education and type of work
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`experience proposed by Dr. Knodel, I note that a person of ordinary skill in the art
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`2
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`Ethicon Exhibit 2021.005
`Intuitive v. Ethicon
`IPR2018-01248
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`would additionally have had an understanding as to how the instrument design can
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`affect the clinical outcomes associated with instrument use (e.g., how effective a
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`particular design is at forming staples). The opinions I express in this declaration
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`are given from the perspective of a person of ordinary skill in the art as of the
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`effective filing date of the 969 Patent, based on the level of education and work
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`experience proposed by Dr. Knodel in conjunction with the understanding of
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`instrument design discussed above. I meet the criteria set forth by Dr. Knodel as
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`well as the additional criteria set forth above, and consider myself a person with at
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`least ordinary skill in the art pertaining to the 969 Patent.
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`III. QUALIFICATIONS
`7.
`I am currently an Associate Professor of Mechanical Engineering at
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`the University of Michigan, a position I have held since 2013. Prior to being
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`promoted to Associate Professor, I was an Assistant Professor at the University of
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`Michigan from 2007-2013. I am also the Director of the Precision Systems Design
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`Laboratory at the University of Michigan (“PSDL”). My research in the PSDL
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`covers machine and mechanism design, flexure mechanisms, parallel kinematics,
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`mechatronic systems, flexible system dynamics and controls, and precision
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`engineering. Specific research projects that I have worked on include medical
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`devices for minimally invasive surgery, motion stages for metrology and
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`3
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`Ethicon Exhibit 2021.006
`Intuitive v. Ethicon
`IPR2018-01248
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`manufacturing, electromagnetic and electrostatic actuators, and micro-
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`electromechanical systems.
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`8.
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`In addition to my employment at the University of Michigan, I am
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`also the cofounder and current Chief Technology Officer of FlexDex Surgical.
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`FlexDex is an early stage technology startup created based on research performed
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`in the PSDL. FlexDex develops surgical tools for use in minimally invasive (i.e.,
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`laparoscopic) surgical procedures.
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`9.
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`I received my Sc.D. in Mechanical Engineering from the
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`Massachusetts Institute of Technology (“MIT”) in 2004. Prior to receiving my
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`Sc.D. at MIT, I earned a Bachelor’s degree in Mechanical Engineering from the
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`Indian Institute of Technology, Kanpur in 1998, and a Master’s degree in
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`Mechanical Engineering from Rensselaer Polytechnic Institute in 2000.
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`10. Further details regarding my education and work experience are
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`contained in my CV as Appendix A. I am being compensated at an hourly rate of
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`$750, which is my standard rate for consulting engagements. My compensation is
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`not dependent on the substance of my statements in this Declaration or the
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`outcome of this case.
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`IV. RELEVANT LEGAL STANDARDS
`11.
`I am not a lawyer, and I offer no legal opinions in this declaration. I
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`have, however, been advised by counsel as to various legal standards that apply to
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`4
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`Ethicon Exhibit 2021.007
`Intuitive v. Ethicon
`IPR2018-01248
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`the technical issues I address in this declaration, and I have applied those standards
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`in arriving at my conclusions.
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`12.
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`I understand that the claims of a patent are presumed valid, and a
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`Petitioner in an inter partes review proceeding must prove invalidity of the
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`challenged claims by a preponderance of the evidence.
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`13.
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`I have been informed that, when determining whether the challenged
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`claims of the 969 Patent are invalid as anticipated, one must determine whether
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`each and every claim limitation as arranged in a claim is found in a single prior art
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`reference, expressly or inherently. I have been informed that a prior art reference
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`does not anticipate a claim if it is missing even one claim limitation.
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`14.
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`I have been informed that, when analyzing whether the challenged
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`claims of the 969 Patent are invalid as obvious, one must determine whether the
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`invention in each claim of the 969 Patent would have been obvious to a person of
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`ordinary skill in the art, taking into account 1) the scope and content of the prior
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`art; 2) the differences between the prior art and the claimed invention; 3) the level
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`of ordinary skill in the art; and 4) any secondary considerations of non-
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`obviousness.
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`15.
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`I have been informed that a determination of obviousness requires that
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`a person of ordinary skill in the art would have had a reason to modify or combine
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`prior art references to achieve the claimed invention. I have also been informed
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`5
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`Ethicon Exhibit 2021.008
`Intuitive v. Ethicon
`IPR2018-01248
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`that a determination of obviousness requires that a person of ordinary skill have a
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`reasonable expectation of success in combining the prior art references to achieve
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`the claimed invention.
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`16.
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`I have been informed that secondary considerations may show that the
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`claimed subject matter is not obvious. These secondary considerations can include,
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`for example, commercial success (evidence of commercial success that can be
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`attributed to the merits of the invention), failure of others (evidence that others
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`have tried and failed to solve the problem or satisfy the need resolved by the
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`claimed invention), and skepticism (evidence that those of skill in the art were
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`skeptical as to the merits of the invention, or even taught away from the invention).
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`V. OVERVIEW OF THE TECHNOLOGY DISCLOSED IN THE 969
`PATENT
`17. The 969 Patent was filed on February 9, 2012 as Application No.
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`13/369,609 (which was based on a series of continuation and continuation-in-part
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`applications stemming from Application No. 11/651,807, filed on January 10,
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`2007, now U.S. Patent No. 8,456,520) and issued on July 9, 2013. The named
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`inventor is Frederick E. Shelton, IV.
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`18. The 969 Patent generally relates to surgical instruments for use in
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`minimally invasive surgical procedures. See, e.g., Ex. 1001 at 85:37-50 (“In
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`addition, the present invention may be in laparoscopic instruments, for example.”).
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`An exemplary surgical instrument described in the 969 Patent is a surgical stapler,
`6
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`Ethicon Exhibit 2021.009
`Intuitive v. Ethicon
`IPR2018-01248
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`which can also be referred to as an endocutter or a linear cutter. See, e.g., id. at
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`1:66-2:24. Surgical staplers include an end effector, which comprises a pair of jaws
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`that are configured to grasp and clamp on tissue within the body of a patient. Id.
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`One of the jaws can include a staple cartridge that holds a plurality of staples,
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`while the other jaw is generally referred to as an anvil. See id. Once the tissue is
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`secured between the jaws, a driver can traverse a channel in the staple cartridge,
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`which drives the staples and causes them to be deformed against the anvil to form
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`several rows of staples that secure the tissue. See id. The end effector can also
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`include a cutting instrument, such as a knife, which advances between the rows of
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`staples to cut the tissue after it has been secured with the staples. See id. The figure
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`below provides an exploded view of an exemplary end effector described in the
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`969 Patent, including the jaw, staple cartridge, lower jaw, and driver for driving the
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`staples:
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`7
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`Ethicon Exhibit 2021.010
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 3
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`19. The 969 Patent discloses handheld instrument embodiments, as well
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`as those intended for use with robotic surgical systems. See e.g., Ex. 1001 at 3:6-
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`4:36. The figure on the left illustrates a handheld instrument embodiment, which
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`can be actuated via a trigger, while the figure on the right illustrates a robotic
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`instrument embodiment, which is configured to be attached to a robotic surgical
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`system and actuated via a remote console:
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`8
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`Ethicon Exhibit 2021.011
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 22
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`Ex. 1001 at Fig. 132
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`20.
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`In either embodiment, the end effector is operably coupled to an
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`elongate shaft. This arrangement facilitates insertion of the end effector into the
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`body in a minimally invasive manner.
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`21. The 969 Patent is further directed to implementations of a “surgical
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`instrument for use with a robotic system.” Ex. 1001, Abstract. The surgical tool of
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`independent claim 24, for example, includes, a transmission assembly in meshing
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`engagement with a gear-driven portion to apply control motions to a selectively
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`movable component of an end effector. See, e.g., Ex. 1001 at 34:36-43 (“[A] knife
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`drive gear 2432 is attached to the drive shaft segment 2430 and is meshing
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`engagement with a drive knife gear 2434 that is attached to the end effector drive
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`shaft 2336. Thus, rotation of the drive shaft segment 2430 will result in the rotation
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`of the end effector drive shaft 2336 to drive the cutting instrument 2332 and sled
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`9
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`Ethicon Exhibit 2021.012
`Intuitive v. Ethicon
`IPR2018-01248
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`2333 distally through the surgical staple cartridge….”); id. at 85:4-8 (“In various
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`embodiments, the gears of the knife gear assembly 6560 are sized to generate the
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`forces needed to drive the cutting instrument through the tissue clamped in the
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`surgical end effector 6012 and actuate staples therein.”). As shown below in Figure
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`132, the claimed surgical instrument includes a tool mounting portion that is
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`operably coupled to the shaft, and is configured to operably interface with a tool
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`drive assembly of a robotic system. Also shown below is Figure 136, which
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`illustrates a transmission that includes a plurality of gears that are in meshing
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`engagement with a gear driven knife bar to apply control motions to the cutting
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`instrument and sled of an end effector. Ex. 1001 at 84:38-85:16.
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`Ex. 1001 at Fig. 132
`10
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`Ethicon Exhibit 2021.013
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 136
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`22. Claim 24 further requires an elongated shaft comprising proximal and
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`distal spine portions coupled at an articulation joint to facilitate articulation of the
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`end effector. See Ex. 1001 at Claim 24. The 969 Patent also discloses exemplary
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`articulation joints that facilitate articulation about one or two axes. In each of these
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`exemplary embodiments, the articulation joint is operably coupled to the tool
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`mounting portion, such that the rotary members, which are controlled remotely
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`from the surgeon’s console, control the articulation about the articulation joint.
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`Figure 35, for example, illustrates an articulation joint that facilitates articulation
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`about a single axis transverse the longitudinal axis of the elongate shaft. See Ex.
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`1001 at 27:19-47.
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`11
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`Ethicon Exhibit 2021.014
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 35
`As shown in Figure 34, which depicts the same embodiment viewed from behind
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`the tool mounting portion, the articulation joint is controlled by articulation nut
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`2260 at the proximal end of the shaft. Id. at 30:65-31:3. The articulation nut 2260
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`is, in turn, driven by the rotary motion of articulation drive gear 2274, which
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`receives rotary motion from articulation gear 2272, which in turn receives rotary
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`motion from the robotic system through a driven element on the adapter side of the
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`tool mounting portion. Id. at 31:3-16.
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`12
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`Ethicon Exhibit 2021.015
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 34
`23. Figure 133 illustrates articulation about two axes, one that is
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`transverse to the longitudinal tool axis (designated “LT”), and one that is
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`transverse to both the first articulation axis and LT. Ex. 1001 at 77:38-46. These
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`axes are designated “TA1” and “TA2” in Figure 133, which provides a more
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`detailed view of the articulation joint 6100. As can be seen in Figure 133, this
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`embodiment of the articulation joint is controlled by two pairs of articulation
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`cables, designated 6144, 6146, 6150, and 6152.
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`13
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`Ethicon Exhibit 2021.016
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 133
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`
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`Like the articulation joint of the embodiments in Figures 34-35, the articulation
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`joint in Figure 133 is operably coupled to the tool mounting portion by the
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`articulation cables 6144, 6146, 6150, and 6152, allowing the articulation joint to be
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`operated by rotary motion received from the robotic system. As indicated by the
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`red lines below in Figure 136, the articulation cables 6144 and 6150 enter the tool
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`mounting portion through passages in the instrument shaft (the cables 6146 and
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`6152, which run parallel to 6144 and 6150, are not visible in this perspective). Id.
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`at 78:51-67.
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`14
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`Ethicon Exhibit 2021.017
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 136
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`24. As shown in Figure 137, below, the articulation cables couple to an
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`articulation control arrangement 6160 on the tool mounting portion. Id. at 79:28-
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`53. As shown in great detail in Figure 137, the articulation control arrangement is,
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`through a series of push cables and gears, coupled to the articulation drive gear
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`6322, which receives rotary motion from the robotic system through a rotary
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`element on the adapter side of the tool mounting portion, thus allowing the robotic
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`system to operate the articulation joint. Id. at 79:54-80:39.
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`15
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`Ethicon Exhibit 2021.018
`Intuitive v. Ethicon
`IPR2018-01248
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`Ex. 1001 at Fig. 137
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`25. The 969 Patent describes that the claimed invention provides several
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`advantages. In particular, the disclosed transmission arrangement enables an
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`instrument that can (i) articulate about two different axes that are substantially
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`transverse to each other and the longitudinal tool axis; (ii) rotate the end effector
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`about the longitudinal tool axis; (iii) open and close the end effector anvil to clamp
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`tissue; and (iv) fire the device to cut and staple tissue. Ex. 1001 at 85:19-32. The
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`969 Patent describes that the disclosed gear-driven system improves upon the prior
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`art by enabling a surgical instrument that can generate the magnitude of forces
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`16
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`Ethicon Exhibit 2021.019
`Intuitive v. Ethicon
`IPR2018-01248
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`required to effectively cut and fasten tissue, which is critical for surgical staplers.
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`Id. at 23:6-29, 84:20-26, 85:4-10.
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`VI. PROSECUTION HISTORY OF THE 969 PATENT
`26. Ethicon filed Application No. 13/369,609 on February 9, 2012, which
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`ultimately issued as the 969 Patent on July 9, 2013. The 969 Patent is a
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`continuation of application No. 13/118,259, which was filed on May 27, 2011, and
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`is a continuation in part of application No. 11/651/807, which was filed on January
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`10, 2007.
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`27. The originally filed claims in the application that resulted in the 969
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`Patent were initially rejected by the examiner. See Ex. 1002 at p. 280-84, 8-30-
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`2012 (Notification Date) Non-Final Rejection. In response to the rejection, Ethicon
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`added a new claim that ultimately issued as Claim 24 (original Claim 26). See id. at
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`p. 289-317, 11-13-2012 Amendment After Non-Final Rejection. Claim 24 of the
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`969 Patent was never the subject of a rejection, and was ultimately allowed by the
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`examiner without amendment. See id. at p. 328, 12-11-2012 Notice of Allowance.
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`VII. CLAIM CONSTRUCTION
`28.
`I have been informed that the claims of the 969 Patent should be
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`construed using the broadest reasonable construction in light of the specification of
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`the patent. I have been informed that the broadest reasonable construction is an
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`interpretation that corresponds with what and how an inventor describes his
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`17
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`Ethicon Exhibit 2021.020
`Intuitive v. Ethicon
`IPR2018-01248
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`invention in the specification, meaning that the interpretation must be consistent
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`with the specification.
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`29.
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`In rendering my opinions, to the extent that I do not provide a
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`construction for a term, I have applied that term’s ordinary meaning to a person of
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`ordinary skill in the art, in light of the specification.
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`VIII. OVERVIEW OF THE PRIOR ART CITED BY PETITIONER
`30.
`I understand that Petitioner has asserted that claims 24-26 of the 969
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`Patent are invalid as anticipated and/or obvious based on various prior art
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`references. Below I provide a brief description of each reference that Petitioner has
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`relied on.
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`A. Ex. 1006, Prisco (U.S. Patent No. 8,545,515)
`31. U.S. Patent No. 8,545,515 (“Prisco”) was filed on November 13,
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`2009, and issued on October 1, 2013. The named inventors are Giuseppe Maria
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`Prisco, Craig R. Gerbi, Theodore W. Rogers, and John Ryan Steger. The patent
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`was originally assigned to an affiliate of Petitioner, Intuitive Surgical Operations,
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`Inc.
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`32. Prisco concerns endoscopic surgical instruments that extend through
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`rigid, curved cannulas. Ex. 1006 at Abstract. In particular, Prisco discloses that the
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`endoscopic surgical instruments are flexible to allow for easier insertion and
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`18
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`Ethicon Exhibit 2021.021
`Intuitive v. Ethicon
`IPR2018-01248
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`removal through the rigid, curved cannulas, while maintaining effective
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`triangulation and action at the surgical site. Ex. 1006 at 1:58-2:42.
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`In one aspect, a surgical system includes a robotic
`manipulator, a curved cannula, and an instrument with a
`passively flexible shaft that extends through the curved
`cannula. The robotic manipulator moves the curved
`cannula around a remote center of motion that is placed at
`an opening into a patient’s body (e.g., an incision, a natural
`orifice) so that the curved cannula provides a triangulation
`angle for the surgical instrument at the surgical site. In one
`implementation, an endoscope and two such curved
`cannulas with distal ends oriented towards a surgical site
`from different angles are used so that effective instrument
`triangulation is achieved, which allows the surgeon to
`effectively work at and view the surgical site.
`
`Ex. 1006 at 1:58-2:3.2
`
`33. Prisco further discloses a control system for a robotic surgical system
`
`that uses kinematic data associated with the curved cannula to provide for an
`
`intuitive control experience for the surgeon.
`
`In another aspect, a control system for a robotic surgical
`system with a curved cannula is disclosed. The control
`
`
`
`2 All emphasis in this declaration is added unless otherwise noted.
`
`19
`
`Ethicon Exhibit 2021.022
`Intuitive v. Ethicon
`IPR2018-01248
`
`
`
`
`
`system uses kinematic data associated with the curved
`cannula. To provide an intuitive control experience for the
`surgeon,
`the control system commands a robotic
`manipulator to move the curved cannula and its instrument
`in response to the surgeon’s inputs at a master manipulator
`as if the instrument were positioned along a straight axis
`that extends from the distal end of the curved cannula,
`generally tangent to the distal end of the cannula's curved
`section.
`
`Ex. 1006 at 2:51-60.
`
`34.
`
`In Figures 4C and 5, Prisco discloses examples of its curved cannula
`
`systems. Figure 4C depicts curved cannulas 416a and 416b, which allow surgical
`
`instruments to be introduced into the surgical site. Figure 5 depicts the surgical
`
`instruments with an end effector 504 and a passively flexible shaft 506 with
`
`sections 506a-506c. The shaft sections 506a-506c are sufficiently rigid to transmit
`
`shaft roll motions.
`
`20
`
`Ethicon Exhibit 2021.023
`Intuitive v. Ethicon
`IPR2018-01248
`
`
`
`
`
`
`
`
`
`Ex. 1006 at Figs. 4C and 5
`
`FIG. 5 is a diagrammatic view of an illustrative flexible
`instrument 500 used with a curved cannula. Instrument
`500
`includes a proximal end
`force
`transmission
`mechanism 502, a distal end surgical end effector 504, and
`a shaft 506 that couples force transmission mechanism 502
`and end effector 504. In one implementation, shaft 506 is
`about 43 cm long. In some implementations, shaft 506 is
`passively flexible and includes three sections-a proximal
`section 506a, a distal section 506c, and a middle section
`
`21
`
`Ethicon Exhibit 2021.024
`Intuitive v. Ethicon
`IPR2018-01248
`
`
`
`
`
`506b that is between proximal and distal sections 506a,
`506c.
`
`Ex. 1006 at 12:8-17.
`
`For instruments that require an end effector roll DOF via
`shaft roll, all three sections 506a-506c are torsionally rigid
`enough to transmit roll motion from the proximal end of
`the instrument to distal surgical end effector 504.
`Examples are described in reference to FIGS. 8A-8D,
`below.
`
`Ex. 1006 at 12:45-49.
`
`35. Because these endoscopic instruments are required to be capable of
`
`passing through a rigid, curved cannula, this significantly increases the complexity
`
`of the instrument shafts’ structures and components.
`
`36. For example, as illustrated in Figures 8A through 8D and described in
`
`the corresponding specification text, Prisco’s instrument includes support tubes
`
`806a and 806b, which “guide tension elements 804a,804b and keep them from
`
`buckling or kinking within shaft 506.” Ex. 1006 at 17:5-8 (“As shown in FIG. 8A,
`
`tension elements 804a,804b extend through support tubes 806a,806b respectively,
`
`which guide tension elements 804a,804b and keep them from buckling or kinking
`
`within shaft 506.”).
`
`37. These support tubes also include friction reducing sheaths 808a, 808b
`
`to reduce friction as the tension elements slide inside their support tubes. Ex. 1006
`22
`
`Ethicon Exhibit 2021.025
`Intuitive v. Ethicon
`IPR2018-01248
`
`
`
`
`
`at 17:12-16 (“To reduce friction as each tension element slides inside its support
`
`tube, a friction reducing sheath 808a,808b is placed between the tension element
`
`and the inner wall of the support tube. In one implementation, sheaths 808a,808b
`
`are PTFE, and other materials may be used.”).
`
`38. Additionally, an inner shaft tube 810 is provided to enclose both
`
`support tubes 806a and b and to provide torsional stiffness during shaft rotation.
`
`Ex. 1006 at 17:16-20 (“Both support tubes 806a,806b are placed within a single
`
`inner shaft tube 810. In one implementation, a flat-spiral stainless steel wire is used
`
`for inner shaft tube 810 to provide torsional stiffness during roll.”).
`
`39. An outer shaft tube 812 surrounds inner shaft tube 810, and is further
`
`surrounded by a skin 814 that “facilitates shaft 506 sliding within the curved
`
`cannula.” Ex. 1006 at 17:20-27 (“An outer shaft tube 812 (e.g., braided stainless
`
`steel mesh or other material suitable to protect the shaft components) surrounds
`
`inner shaft tube 810. An elastomer skin 814 (e.g., Pellothane®, or other suitable
`
`material) surrounds the outer shaft tube 812. Skin 814 protects the inner
`
`components of shaft 506 from direct contamination by, e.g., body fluids during
`
`surgery, and the skin facilitates shaft 506 sliding within the curved cannula. In
`
`some implementations shaft 506 is approximately 5.5 mm (0.220 inches) outer
`
`diameter.”).
`
`23
`
`Ethicon Exhibit 2021.026
`Intuitive v. Ethicon
`IPR2018-01248
`
`
`
`
`
`40. Flexible shaft 506, skin 814, outer tube 812 and inner tube 810,
`
`supports tubes 806a and 806b, friction reducing sheaths 808a and 808b, and
`
`tension elements 804a and 804b are illustrated in Figure 8a below.
`
`Ex. 1006 at Fig. 8A
`
`
`
`41. As illustrated above, these additional structures (such as a support
`
`tubes and friction reducing sheaths) that are necessary for the design of a flexible
`
`instrument that passes through a curved cannula require a significantly more
`
`complicated instrument shaft design than a surgical instrument that passes through
`
`a straight cannula. The inclusion of these components greatly reduces the amount
`
`of available space within the instrument shaft for providing additional mechanisms
`
`that run through the shaft, such as mechanisms that could control articulation.
`
`24
`
`Ethicon Exhibit 2021.027
`Intuitive v. Ethicon
`IPR2018-01248
`
`
`
`
`
`42. Prisco discusses a wrist (i.e., an articulation joint) and incorporates
`
`Cooper—U.S. Patent No. 6,817,974—for the purpose of explaining that a wrist has
`
`been omitted. Specifically, Prisco states that omitting the articulation joint
`
`simplifies the instrument and reduces instrument dimensions. Prisco explains that
`
`“[m]any instrument implementations do not include such a wrist,” and that
`
`“[o]mitting the wrist simplifies the number of actuation force interfaces” between
`
`the robotic surgery system and the instrument. This “omission also reduces the
`
`number of force transmission elements (and hence, instrument complexity and
`
`dimensions) that would be necessary between the force transmission mechanism
`
`404a and the proximal force transmission mechanism 404a and the distally
`
`actuated piece” of the surgical instrument.
`
`A wrist to provide one or more end effector DOF’s (e.g.,
`pitch, yaw; see e.g., U.S. Pat. No. 6,817,974 (filed Jun. 28,
`2002) (disclosing “Surgical Tool Having Positively
`Positionable Tendon-Actuated Multi-Disk Wrist Joint”),
`which is incorporated herein by reference) is optional and
`is not shown. Many instrument implementations do not
`include such a wrist. Omitting the wrist simplifies the
`number of actuation force interfaces between PSM 204a
`and instrument 402a, and the omission also reduces the
`number of force transmission elements (and hence,
`instrument complexity and dimensions) that would be
`
`25
`
`Ethicon Exhibit 2021.028
`Intuitive v. Ethicon
`IPR2018-01248
`
`
`
`
`
`necessary between the proximal force transmission
`mechanism 404a and the distally actuated piece.
`
`Ex. 1006 at 10:43-55.
`
`43. Because Prisco discloses that omitting the wrist articulation
`
`mechanism simplifies the instrument, Prisco does not disclose an instrument for its
`
`curved cannula instrument that includes an articulation joint and mechanisms
`
`associated with such a joint for driving articulation. Rather, Prisco discloses that its
`
`instrument base is a modified version of the da Vinci Surgical System instrument
`
`base. In particular, the instrument base has been modified to eliminate the
`
`articulation mechanisms. Ex. 1006 at 14:59-64 (“As shown in FIG. 7A, the force
`
`transmission mechanism of a surgical instrument used in a da Vinci® Surgic
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