UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner
`
`IPR2018-01254
`U.S. Patent No. 8,479,969
`
`
`
`
`
`
`
`DECLARATION OF DR. SHORYA AWTAR
`
`
`
`
`
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`
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`Ethicon Exhibit 2005.001
`Intuitive v. Ethicon
`IPR2018-01254
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`TABLE OF CONTENTS
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`Page
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`I.
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`INTRODUCTION .......................................................................................... 1
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`II.
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`PRIORITY DATE AND LEVEL OF ORDINARY SKILL IN THE
`ART ................................................................................................................. 2
`
`III. QUALIFICATIONS ........................................................................................ 3
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`IV. RELEVANT LEGAL STANDARDS ............................................................. 4
`
`V. OVERVIEW OF THE TECHNOLOGY DISCLOSED IN THE 969
`PATENT .......................................................................................................... 6
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`VI. PROSECUTION HISTORY OF THE 969 PATENT ................................... 16
`
`VII. CLAIM CONSTRUCTION .......................................................................... 16
`
`VIII. OVERVIEW OF THE PRIOR ART CITED BY PETITIONER ................. 17
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`A. Giordano .............................................................................................. 17
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`B.
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`Shelton ................................................................................................. 22
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`C. Wallace ................................................................................................ 25
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`D.
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`Tierney ................................................................................................. 29
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`E.
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`Hueil .................................................................................................... 30
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`IX. PETITIONER HAS NOT DEMONSTRATED THAT ANY
`COMBINATION OF GIORDANO, SHELTON, WALLACE,
`TIERNEY, AND HUEIL RENDERS OBVIOUS THE CLAIMS OF
`THE 969 PATENT ........................................................................................ 32
`
`A.
`
`Claim 24: Combining Shelton’s endocutter with Tierney’s
`robotic system, Wallace’s
`tool mount, and Giordano’s
`articulation mechanism does not result in an instrument that
`includes “a tool mounting portion operably coupled to a distal
`end of said proximal spine portion.” ................................................... 34
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`i
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`Ethicon Exhibit 2005.002
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`B.
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`C.
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`D.
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`E.
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`F.
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`Claims 11 and 24: A person of ordinary skill in the art would
`have been deterred from attempting any of the combinations
`proposed for claims 11 and 24. ........................................................... 38
`
`Claims 11 and 24: A person of ordinary skill in the art would
`not have been motivated to combine Shelton’s endocutter with
`Tierney’s robotic system, Wallace’s tool base, and Wallace’s
`articulation mechanism ....................................................................... 43
`
`Claims 11 and 24: A person of ordinary skill in the art would
`not have had a reasonable expectation of success in combining
`the prior art as proposed. ..................................................................... 49
`
`Claims 1-10: A person of ordinary skill in the art would have
`been deterred from attempting any of the combinations
`proposed for claims 1-10. .................................................................... 58
`
`Claims 1-10: A person of ordinary skill in the art would not
`have had a reasonable expectation of success in combining the
`prior art as proposed. ........................................................................... 58
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`X.
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`JURAT ........................................................................................................... 60
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`ii
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`Ethicon Exhibit 2005.003
`Intuitive v. Ethicon
`IPR2018-01254
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`I.
`
`INTRODUCTION
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`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.
`
`I understand that Petitioner Intuitive Surgical Inc. (“Intuitive”) has
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`asserted that claims 1-11 and 24 of U.S. Patent No. 8,479,969 (the “969 Patent”)
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`are invalid as obvious. I have been asked to give expert opinions and testimony
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`related to the issue of the validity of claims 1-11 and 24 of the 969 Patent,
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`including the background of the technology at issue, and the scope and content of
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`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. 1005), the Patent Owner Response, the transcripts of Dr. Knodel’s
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`depositions (Ex. 2011, as well as his deposition testimony in IPR2018-01247 and
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`IPR2018-01248), and the relevant portions of all exhibits cited in any of the
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`foregoing 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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`as discussed below. All statements made herein of my own knowledge are true,
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`Ethicon Exhibit 2005.004
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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.
`
`PRIORITY DATE AND LEVEL OF ORDINARY SKILL IN THE
`ART
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`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. 1005 at ¶¶ 30-
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`32. 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
`
`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. 1005 at ¶
`
`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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`would additionally have had an understanding as to how the instrument design can
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`Ethicon Exhibit 2005.005
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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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`experienced 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
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`7.
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`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
`
`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,
`
`mechatronic systems, flexible system dynamics and controls, and precision
`
`engineering. Specific research projects that I have worked on include medical
`
`devices for minimally invasive surgery, motion stages for metrology and
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`manufacturing, electromagnetic and electrostatic actuators, and micro-
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`electromechanical systems.
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`3
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`Ethicon Exhibit 2005.006
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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
`
`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.
`
`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
`
`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
`
`$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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`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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`4
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`Ethicon Exhibit 2005.007
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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
`
`challenged claims by a preponderance of the evidence.
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`13.
`
`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
`
`art; 2) the differences between the prior art and the claimed invention; 3) the level
`
`of ordinary skill in the art; and 4) any secondary considerations of non-
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`obviousness.
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`14.
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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
`
`prior art references to achieve the claimed invention. I have also been informed
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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
`
`the claimed invention.
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`15.
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`I have been informed that secondary considerations may show that the
`
`claimed subject matter is not obvious. These secondary considerations can
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`include, for example, commercial success (evidence of commercial success that
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`can be attributed to the merits of the invention), failure of others (evidence that
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`Ethicon Exhibit 2005.008
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`others 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
`
`16. The ’969 Patent was filed on February 9, 2012 as Application No.
`
`13/369,609 (which was based on a series of continuation and continuation-in-part
`
`applications stemming from Application No. 11/651,807, filed on January 10,
`
`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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`17. The 969 Patent generally relates to surgical instruments for use in
`
`minimally invasive surgical procedures. See e.g., Ex. 1001 at 85:37-50 (“In
`
`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,
`
`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
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`jaws that are configured to grasp and clamp on tissue within the body of a patient.
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`Id. 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. 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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`6
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`Ethicon Exhibit 2005.009
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`several rows of staples that secure the tissue. Id. The end effector can also include
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`a cutting instrument, such as a knife, which advances between the rows of staples
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`to cut the tissue after it has been secured with the staples. Id. The figure below
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`provides an exploded view of an exemplary end effector described in the 969
`
`Patent, including the jaw, staple cartridge, lower jaw, and driver for driving the
`
`staples:
`
`
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`Ex. 1001 at Fig. 3
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`Ethicon Exhibit 2005.010
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`18. The 969 Patent discloses handheld instrument embodiments, as well
`
`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
`
`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
`
`system and actuated via a remote console:
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`
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`Ex. 1001 at Figure 22
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`
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`
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`Ex. 1001 at Figure 132
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`19.
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`In either embodiment, the end effector is operably coupled to an
`
`elongate shaft. This arrangement facilitates insertion of the end effector into the
`
`body in a minimally invasive manner.
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`20. The 969 Patent is further directed to implementations of a “surgical
`
`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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`Ethicon Exhibit 2005.011
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`engagement with a gear-driven portion to apply control motions to a selectively
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`moveable component of an end effector. See, e.g., Ex. 1001 at 34:36-43 (“[A]
`
`knife drive gear 2432 is attached to the drive shaft segment 2430 and is meshing
`
`engagement with a drive knife gear 2434 that is attached to the end effector drive
`
`shaft 2336. Thus, rotation of the drive shaft segment 2430 will result in the rotation
`
`of the end effector drive shaft 2336 to drive the cutting instrument 2332 and sled
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`2333 distally through the surgical staple cartridge….”); 85:4-8 (“In various
`
`embodiments, the gears of the knife gear assembly 6560 are sized to generate the
`
`forces needed to drive the cutting instrument through the tissue clamped in the
`
`surgical end effector 6012 and actuate staples therein.”). As shown below in
`
`Figure 132, the claimed surgical instrument includes a tool mounting portion that is
`
`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
`
`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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`9
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`Ethicon Exhibit 2005.012
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`,
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`'\\"\\\‘(\\\
`'lavllarlllnl’l
`
`I
`
`Ex. 1001 at Figure 132
`
`
`
`
`
`
`
`
`
`Gear-Driven Knife Bawr
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`132
`
`
`
`Transmission
`
`Assam bly
`
`Knife Gear
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`Assembiy
`
`L
`
`'
`
`that drives cutting
`instrumentand sled
`
`
`
`
`
` ' ' , '
`
`..
`
`
`
`U '
`
`‘
`
`
`
`Ex. 1001 at Figure 136
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`10
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`Ethicon Exhibit 2005.013
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`21. Claim 24 further requires an elongated shaft comprising proximal and
`
`distal spine portions coupled at an articulation joint to facilitate articulation of the
`
`end effector. See Ex. 1001 at Claim 24. The 969 Patent also discloses exemplary
`
`articulation joints that facilitate articulation about one or two axes. In each of these
`
`exemplary embodiments, the articulation joint is operably coupled to the tool
`
`mounting portion, such that the rotary members, which are controlled remotely
`
`from the surgeon’s console, control the articulation about the articulation joint.
`
`Figure 35, for example, illustrates an articulation joint that facilitates articulation
`
`about a single axis transverse the longitudinal axis of the elongate shaft. See Ex.
`
`1001 at 27:19-47.
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`Ex. 1001 at Fig. 35
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`11
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`Ethicon Exhibit 2005.014
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`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
`
`is, in turn, driven by the rotary motion of articulation drive gear 2274, which
`
`receives rotary motion from articulation gear 2272, which in turn receives rotary
`
`motion from the robotic system through a driven element on the adapter side of the
`
`tool mounting portion. Id. at 31:3-16.
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`Ex. 1001 at Figure 34
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`
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`22. Figure 133 illustrates articulation about two axes, one that is
`
`transverse to the longitudinal tool axis (designated “LT”), and one that is
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`12
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`Ethicon Exhibit 2005.015
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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
`
`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
`
`cables, designated 6144, 6146, 6150, and 6152.
`
`
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`Ex. 1001 at Figure 133
`
`
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`Like the articulation joint of the embodiments in Figures 34-35, the articulation
`
`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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`13
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`Ethicon Exhibit 2005.016
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`operated by rotary motion received from the robotic system. As indicated by the
`
`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.
`
`at 78:51-67.
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`Ex. 1001 at Figure 136
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`
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`23. 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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`Ethicon Exhibit 2005.017
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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
`
`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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`Ex. 1001 at Figure 137
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`
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`24. The 969 Patent describes that the claimed invention provides several
`
`advantages. In particular, the disclosed transmission arrangement enables an
`
`instrument that can (i) articulate about two different axes that are substantially
`
`transverse to each other and the longitudinal tool axis: (ii) rotate the end effector
`
`about the longitudinal tool axis; (iii) open and close the end effector anvil to clamp
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`Ethicon Exhibit 2005.018
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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
`
`art by enabling a surgical instrument that can generate the magnitude of forces
`
`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
`
`25. Ethicon filed Application No. 13/369,609 on February 9, 2012, which
`
`ultimately issued as the 969 Patent on July 9, 2013. The 969 Patent is a
`
`continuation of application No. 13/118,259, which was filed on May 27, 2011, and
`
`is a continuation in part of application No. 11/651/807, which was filed on January
`
`10, 2007.
`
`26. The originally filed claims in the application that resulted in the 969
`
`Patent were initially rejected by the examiner. See Ex. 1002 at p. 280-4. In
`
`response to the rejection, Ethicon added a new claim that ultimately issued as
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`Claim 24. See Id. at p. 289-317. Claim 24 of the 969 Patent was never the subject
`
`of a rejection, and was ultimately allowed by the examiner without amendment.
`
`See Id. at p. 328.
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`VII. CLAIM CONSTRUCTION
`
`27.
`
`I have been informed that the claims of the 969 Patent should be
`
`construed using the broadest reasonable construction in light of the specification of
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`16
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`Ethicon Exhibit 2005.019
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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
`
`invention in the specification, meaning that the interpretation must be consistent
`
`with the specification.
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`28.
`
`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
`
`ordinary skill in the art, in light of the specification.
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`VIII. OVERVIEW OF THE PRIOR ART CITED BY PETITIONER
`
`29.
`
`I understand that Petitioner has asserted that claims 1-11 and 24 of the
`
`969 Patent are invalid as obvious based on various prior art references. Below I
`
`provide a brief description of each reference that Petitioner has relied on.
`
`A. Giordano
`
`30. U.S. Patent Application Publication No. 2008/0167672 (“Giordano”)
`
`was filed on January 10, 2007 and published on July 10, 2008. The named
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`inventors are James R. Giordano, Jeffery S. Swayze, and Frederick E. Shelton, the
`
`latter also being the named inventor of the 969 Patent.
`
`31. Giordano describes a handheld endocutter with a sensor in the end
`
`effector and a control unit in the handle. Ex. 1014 at Abstract. Additionally, the
`
`endocutter described in Giordano had a “power-assist” feature. Id. at [0013]
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`Giordano explains that “power-assist” endocutters had been developed to aid
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`Ethicon Exhibit 2005.020
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`surgeons in performing minimally invasive procedures by reducing the firing force
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`required from the surgeon, i.e., the force with which the surgeon must squeeze the
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`trigger mechanism on a handheld endocutter in order to fire a staple. Id. Because
`
`these power-assist instruments often included electrical components such as
`
`sensors and control systems, which were not found in purely mechanical
`
`endocutters, prior art power-assist designs encountered challenges with the routing
`
`of power or data to and from the end effector, particularly when the instrument
`
`shaft included a “free rotating joint” such as an articulation joint. Id. at [0014].
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`32. To overcome these issues in prior art power-assist endocutters,
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`Giordano’s handheld endocutter featured a passively-powered sensor in the end
`
`effector. The instrument handle included a microcontroller that communicates
`
`wirelessly with the sensor, using the instrument shaft as an antenna to pass signals
`
`between the control unit and sensor in one aspect of the invention. This allowed
`
`the shaft to also incorporate a rotational joint that articulates in one dimension
`
`without the difficulty of routing wires through the joint. Id. at [0015]-[0017].
`
`33.
`
`I will now briefly discuss the relevant aspects of the operation of
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`Giordano’s endocutter, with reference to the embodiment shown in Figures 2 and
`
`7, below.
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`Ethicon Exhibit 2005.021
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`FIG. 2
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`Ex. 1014 at Figure 2
`EX. 1014 at Figure 2
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`Ex. 1014 at Figure 7
`EX. 1014 at Figure 7
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`19
`19
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`Ethicon Exhibit 2005.022
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`Ethicon Exhibit 2005.022
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`34. As shown in Figure 2, which illustrates the surgical instrument, the
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`instrument has an end effector 12 that has a staple cartridge 22 and anvil 24. Ex.
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`1014 at [0036]. The end effector is on the distal end of shaft 8, which features an
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`articulation pivot 14. Id. at [0034].
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`35. The surgeon controls articulation at the pivot 14 using articulation
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`control 16, a mechanism which is situated on the instrument shaft. Id.
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`Additionally, as can be seen on the figure (but not labeled), the instrument has a
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`rotation knob near the reference numeral 6, which the surgeon uses to rotate the
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`shaft. Id.
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`36. The device handle 6 has the closure trigger 18 and firing trigger 20.
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`These triggers control closure of the end effector and firing of the staples,
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`respectively. Id. at [0035].
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`37. Based on the discussion above, it is evident – and a person of ordinary
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`skill in the art would have understood – that Giordano’s endocutter requires four
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`separate inputs from the surgeon in order to control the four different functions
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`discussed: (1) squeezing the closure trigger 18 closes the end effector, (2)
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`squeezing1 the firing trigger 20 fires the stapler, (3) activating articulation control
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`1 Because Giordano’s firing mechanism is power-assisted, the surgeon need not
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`provide the entirety of the force required to fire the stapler, but must still initiate
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`20
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`16 causes the shaft to articulate around pivot 14, and (4) turning the rotation knob
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`causes the shaft to rotate.
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`38. Dr. Knodel opines that Giordano “does not disclose the robotic
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`embodiments of the ’969 Patent.” Ex. 1005 at ¶ 35. I agree with Dr. Knodel that a
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`person of ordinary skill in the art would not have understood Giordano to disclose,
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`teach, or otherwise suggest any embodiments in which Giordano’s endocutter was
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`used with a robotic system.
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`39.
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`I understand that Dr. Knodel has expressed the opinion that Giordano
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`incorporates by reference the entirety of another prior art reference, U.S. Patent
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`No. 6,978,921 (“Shelton”). See Ex. 1005 at ¶ 37. I discuss the Shelton reference
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`in the next section of this declaration. Because the opinions I express regarding the
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`validity of the claims of the 969 Patent do not depend on whether or not Shelton is
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`wholly incorporated by reference into Giordano, I offer no opinion at this time
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`about whether Dr. Knodel’s position on incorporation by reference is correct.
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`the motion of depressing the firing trigger. Additionally, the power-assist
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`mechanism does not assist with providing the force required for closing the end
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`effector to clamp tissue.
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`21
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`B.
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`Shelton
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`40. U.S. Patent No. 6,978,921 (“Shelton”) was filed on May 20, 2003 and
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`issued on December 27, 2005. The named inventors are Frederick E. Shelton,
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`Michael Earl Setser, and William Bruce Weisenburgh, II.
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`41. Shelton also describes a handheld endocutter. Unlike the endocutter
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`discussed above in connection with Giordano, however, Shelton’s endocutter does
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`not include motor-powered firing, and therefore, it does not include any “power-
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`assist” functionality or any of the accompanying electronics.
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`42. Shelton’s Figures 1 and 2, below, illustrate the instrument as a whole
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`and a close-up of the end effector, respectively. Figure 7 provides an exploded
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`view of the handle, showing the various mechanical components.
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`22
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`g.
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`Ulla.
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`
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`FIG. 2
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`154
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`_
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`45
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`_
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`'
`44'
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`"
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`" 7'"
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`Ex. 1015 at Figures 1-2
`EX. 1015 at Figures 1-2
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`23
`23
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`Ethicon Exhibit 2005.026
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`Ex. 1015 at Figure 7
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`
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`43. As can be seen in the figures above, Shelton’s instrument includes a
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`closure sleeve 32 on the instrument shaft. This sleeve opens and closes the end
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`effector when the closure trigger 26 is actuated by the surgeon. Ex. 1015, 5:63-
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`6:3, 7:39-50. A separate firing trigger 28 allows the surgeon to fire the stapler
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`independent of the opening and closing of the end effector. Id., 5:58-62.
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`44. Shelton’s instrument also includes a rotation knob 60, which is shown
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`in Figure 7. It is also shown without the reference numeral in Figure 1, at the
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`24
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`proximal end of the shaft. This knob provides rotation for the shaft when it is
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`turned. Id., 7:16-27.
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`45. As is evident from the description above, and as a person of ordinary
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`skill in the art would have understood, Shelton’s endocutter requires three separate
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`inputs from the surgeon to perform three different instrument operations: (1)
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`pulling closure trigger 26, to close the end effector and clamp tissue; (2) pulling the
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`firing trigger 28, to fire the stapler; and (3) turning the rotation knob to rotate the
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`shaft.
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`46. Shelton does not disclose, teach, or suggest an articulation joint.
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`Shelton also does not disclose, teach, or suggest using its handheld endocutter with
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`a robotic system.
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`C. Wallace
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`47. U.S. Patent No. 6,699,235 (“Wallace”) was filed on June 28, 2002 and
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`issued on March 2, 2004. The named inventors are Daniel T. Wallace, S.
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`Christopher Anderson, and Scott Manzo, and the patent was originally assigned to
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`the Petitioner here, Intuitive Surgical, Inc.
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`48. According to Wallace, existing tools for minimally invasive surgery
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`(which Wallace refers to as “MIS”) often denied the surgeon the flexibility of tool
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`placement that surgeons were used to in open surgery. Ex. 1008, 2:31-34. The
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`rigid shafts found on many laparoscopic tools, for example, made it difficult to
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`25
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`approach the surgical site through small incisions. Id., 2:34-36. When such
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`instruments are used with robotic surgical systems, manipulation and control of the
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`end effectors is a critical aspect. Id., 2:60-61.
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`49. Accordingly, Wallace sought to provide surgical tools that included
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`mechanisms for “three degrees of rotational movement of an end effector around
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`three perpendicular axes to mimic the natural action of a surgeon’s wrist.” Id.,
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`2:61-65. Wallace’s approach to such a mechanism was a rod-based articulation
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`mechanism, shown in Figures 2A and 3:
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`
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`
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`Ex. 1008 at Figures 2A and 3
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`50. The rods of the wrist mechanism are controlled by a robotic tool base
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`62, to which the instrument is coupled. Ex. 1008, 7:37-40. The tool base is shown
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`in Figure 30.
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`26
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`Ex. 1008 at Fig. 30
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`
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`51. The articulation rods 14 in Figures 2A and 3 extend through the shaft
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`of the instrument, and emerge in the tool base as rods 300. Ex. 1008, 13:44-45.
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`On the tool base, the rods are coupled to sector gears 312, which rotate under the
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`control of gears 400. Id., 13:47-54. This rotational input causes individual rods to
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`advance or retract as needed, allowing the instrument to articulate freely in three
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`dimensions around the wrist joint. Id.
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`52. The tool base also includes a gear 420, which rotate