`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`
`
`IPR2019-00880
`U.S. Patent No. 7,490,749
`______________________
`
`DECLARATION OF DR. SHORYA AWTAR
`
`
`
`
`
`
`
`Ethicon Exhibit 2019.001
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`PRIORITY DATE AND LEVEL OF ORDINARY SKILL IN THE
`ART ................................................................................................................. 3
`III. QUALIFICATIONS ........................................................................................ 4
`IV. RELEVANT LEGAL STANDARDS ............................................................. 5
`V. OVERVIEW OF THE TECHNOLOGY DISCLOSED IN THE 749
`PATENT .......................................................................................................... 7
`A.
`Firing Drive ......................................................................................... 10
`B.
`Retraction Assembly ........................................................................... 14
`VI. CLAIM CONSTRUCTION .......................................................................... 20
`A.
`“firing member” .................................................................................. 22
`B.
`“retraction assembly” .......................................................................... 22
`C.
`“firing drive” ....................................................................................... 26
`D.
`“closure drive” ..................................................................................... 29
`VII. OVERVIEW OF THE PRIOR ART CITED BY PETITIONER ................. 31
`A.
`Shelton II (IS-1004)............................................................................. 31
`B.
`Swayze (IS-1005) ................................................................................ 38
`C.
`Shelton I (IS-1006) .............................................................................. 39
`
`
`IX. SHELTON II DOES NOT ANTICIPATE OR RENDER OBVIOUS
`THE CLAIMS OF THE 749 PATENT ......................................................... 59
`
`
`
`i
`
`Ethicon Exhibit 2019.002
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`A.
`
`B.
`
`2.
`
`X.
`
`B.
`
`C.
`
`Shelton II Does Not Anticipate Claims 1 or 3 Because It Does
`Not Disclose the Claimed Retraction Assembly ................................. 60
`Shelton II Does Not Anticipate Claims 1 or 3 if Its Retraction
`1.
`Spring Becomes Disconnected ................................................. 64
`A POSITA Would Not Immediately Envision the Claimed
`Retraction Assembly ................................................................. 68
`Shelton II Does Not Render Obvious the Claimed Invention of
`the 749 Patent ...................................................................................... 80
`SWAYZE DOES NOT ANTICIPATE OR RENDER OBVIOUS THE
`CLAIMS OF THE 749 PATENT .................................................................. 84
`Swayze Does Not Anticipate Claims 1 or 3 Because It Does
`A.
`Not Disclose the Claimed Retraction Assembly ................................. 85
`Swayze Does Not Anticipate Claims 1 and 3 if Its Retraction
`Spring Becomes Disconnected ............................................................ 87
`It Would Not Have Been Obvious to a Person of Ordinary Skill
`To Remove the Retraction Spring From Swayze’s Device ................ 89
`XI. SHELTON I CANNOT ANTICIPATE OR RENDER OBVIOUS
`THE CHALLENGED CLAIMS OF THE 749 PATENT ............................. 98
`XII. JURAT ........................................................................................................... 99
`
`
`
`
`
`
`ii
`
`Ethicon Exhibit 2019.003
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`I.
`
`INTRODUCTION
`1. My name is Dr. Shorya Awtar. I have been retained by counsel for
`
`
`
`Patent Owner Ethicon LLC (“Ethicon”) in the above captioned inter partes review
`
`to consult with counsel, review documents, form opinions and prepare expert
`
`declarations, and be available to testify as to my opinions.
`
`2.
`
`I understand that Petitioner Intuitive Surgical Inc. (“Intuitive”) has
`
`asserted that Claims 1 and 3 of U.S. Patent No. 7,490,749 (the “749 Patent”) are
`
`invalid as anticipated and/or obvious. I have been asked to give expert opinions
`
`and testimony related to the issue of the validity of Claims 1 and 3 of the 749
`
`Patent, including the background of the technology at issue, and the scope and
`
`content of the prior art.
`
`3. My opinions are based on reviewing the relevant portions of the
`
`documents listed below:
`
`IS-1001
`
`U.S. Patent No. 7,490,749 to Schall, et al. (“749 Patent”)
`
`IS-1002
`
`IS-1003
`
`IS-1004
`
`IS-1005
`
`IS-1006
`
`
`
`Excerpts from the Prosecution History of the 749 Patent (“the
`Prosecution History”)
`
`Declaration of Dr. Knodel, including Curriculum Vitae
`
`US Patent Publication No. 2006/0175375 (“Shelton II”)
`
`US Patent Publication No. 2005/0178813 (“Swayze”)
`
`U.S. Patent No. 8,322,455
`
`1
`
`Ethicon Exhibit 2019.004
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`Complaint for Patent Infringement, Ethicon LLC, et al. v. Intuitive
`Surgical, Inc., et al., Case No. 1:18-cv-01325 (D. Del. Aug. 27,
`2018)
`
`U.S. Patent No. 5,941,442
`
`U.S. Patent No. 5,865,361
`
`Excerpts from McGraw-Hill Dictionary of Scientific and Technical
`Terms
`
`
`
`
`
`
`
`IS-1007
`
`IS-1010
`
`IS-1011
`
`IS-1012
`
`
`
`
`
`
`
`Ex. 2010
`
`U.S. Patent No. 5,465,895 (1995)
`
`Ex. 2011
`
`U.S. Patent No. 5,632,432 (1997)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Ex. 2018
`
`Deposition Transcript of Dr. Bryan Knodel (December 13, 2019)
`
`
`4.
`
`The opinions I have formed as explained herein are informed by and
`
`based on my consideration of the documents listed above, as well as my own
`
`knowledge and experience based upon my work in the relevant field of technology,
`
`as discussed below. All statements made herein of my own knowledge are true,
`
`and all statements made herein based on information and belief are believed to be
`
`
`
`2
`
`Ethicon Exhibit 2019.005
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`true. Although I am being compensated for my time in preparing this declaration,
`
`the opinions articulated herein are my own, and I have no stake in the outcome of
`
`this proceeding or any related litigation or administrative proceedings. My study is
`
`ongoing, and I may supplement or amend these opinions based on the production
`
`of additional evidence, as a result of further analysis, or in rebuttal to positions
`
`subsequently taken by Petitioner and/or Dr. Knodel.
`
`II.
`
`PRIORITY DATE AND LEVEL OF ORDINARY SKILL IN THE
`ART
`5.
`The 749 Patent resulted from the filing of Application No.
`
`11/729,355, which was filed on March 28, 2007. See IS-1001 at page 1.
`
`
`
`
`
`
`
`6.
`
`I understand that Dr. Knodel has opined that a person of ordinary skill
`
`in the art for the 749 Patent would include someone who had the equivalent of a
`
`bachelor’s degree or higher in mechanical engineering with at least 3 years of work
`
`experience in the design of comparable surgical devices. IS-1003 at ¶ 25. Further,
`
`I understand that Dr. Knodel has opined that additional education in a relevant
`
`field, such as mechanical engineering, or industry experience may compensate for
`
`a deficit in one of the other aspects of the requirements above. Id. I have adopted
`
`this level of ordinary skill in the art for the purposes of my analysis set forth in this
`
`declaration. The opinions I express in this declaration are given from the
`3
`
`
`
`Ethicon Exhibit 2019.006
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`perspective of a person of ordinary skill in the art as of the date of invention of the
`
`749 Patent (May 2006).1 I meet the criteria set forth by Dr. Knodel, and consider
`
`myself a person with at least ordinary skill in the art pertaining to the 749 Patent.
`
`III. QUALIFICATIONS
`7.
`I am currently an Associate Professor of Mechanical Engineering at
`
`the University of Michigan, a position I have held since 2013. Prior to being
`
`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
`
`Laboratory at the University of Michigan (“PSDL”). My research in the PSDL
`
`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
`
`manufacturing, electromagnetic and electrostatic actuators, and micro-
`
`electromechanical systems.
`
`
`1 I note that the perspective of a person of ordinary skill in the art would not have
`
`materially changed between May 2006 and the March 2007 filing of the 749
`
`Patent. Accordingly, the difference in dates would not impact my analysis.
`
`
`
`4
`
`Ethicon Exhibit 2019.007
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`8.
`
`In addition to my employment at the University of Michigan, I am
`
`also the cofounder of FlexDex Surgical. 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., laparoscopic) surgical procedures.
`
`9.
`
`I received my Sc.D. in Mechanical Engineering from the
`
`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
`
`Indian Institute of Technology, Kanpur in 1998, and a Master’s degree in
`
`Mechanical Engineering from Rensselaer Polytechnic Institute in 2000.
`
`10. Further details regarding my education and work experience are
`
`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
`
`not dependent on the substance of my statements in this Declaration or the
`
`outcome of this case.
`
`IV. RELEVANT LEGAL STANDARDS
`11.
`I am not a lawyer, and I offer no legal opinions in this report. I have,
`
`however, been advised by counsel as to various legal standards that apply to the
`
`technical issues I address in this declaration, and I have applied those standards in
`
`arriving at my conclusions.
`
`
`
`5
`
`Ethicon Exhibit 2019.008
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`12.
`
`I understand that the claims of a patent are presumed valid, and a
`
`Petitioner in an inter partes review proceeding must prove invalidity of the
`
`challenged claims by a preponderance of the evidence.
`
`13.
`
`I have been informed that determining whether the challenged claims
`
`of the 749 Patent are invalid as “anticipated” requires an analysis of whether each
`
`and every claim element as set forth in a claim is found, expressly or inherently, in
`
`a single prior art reference. I understand that if a prior art reference is missing
`
`even one claim element, then it cannot anticipate a claim.
`
`14.
`
`I have been informed that, when analyzing whether the challenged
`
`claims of the 749 Patent are invalid as obvious, one must determine whether the
`
`invention in each claim of the 749 Patent would have been obvious to a person of
`
`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-
`
`obviousness.
`
`15.
`
`I have been informed that a determination of obviousness requires that
`
`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
`
`that a determination of obviousness requires that a person of ordinary skill have a
`
`
`
`6
`
`Ethicon Exhibit 2019.009
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`reasonable expectation of success in combining the prior art references to achieve
`
`the claimed invention.
`
`16.
`
`I have been informed that secondary considerations may show that the
`
`claimed subject matter is not obvious. These secondary considerations can include,
`
`for example, commercial success (evidence of commercial success that can be
`
`attributed to the merits of the invention), failure of others (evidence that others
`
`have tried and failed to solve the problem satisfy the need resolved by the claimed
`
`invention), and skepticism (evidence that those of skill in the art were skeptical as
`
`to the merits of the invention, or even taught away from the invention).
`
`V. OVERVIEW OF THE TECHNOLOGY DISCLOSED IN THE 749
`PATENT
`17. The 749 Patent relates to a surgical instrument. IS-1001 at 1:17:24
`
`(“The present invention relates in general to endoscopic surgical instruments….”).
`
`The exemplary surgical instrument disclosed in the specification is a surgical
`
`stapler that staples and cuts tissue, which can be referred to as an endocutter or a
`
`linear cutter. IS-1001 at 5:34-41 (“a surgical stapling and severing instrument 10
`
`that is capable of practicing the unique benefits of the present invention”). The
`
`749 Patent describes that the disclosed instrument can be utilized in endoscopic
`
`and other surgical procedures. IS-1001 at 6:56-64.
`
`18. Surgical staplers can include an end effector coupled to a handle
`
`assembly by an elongate shaft, as shown below. IS-1001 at 5:38-43.
`7
`
`
`
`Ethicon Exhibit 2019.010
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`IS-1001 at Figure 1 (annotations in red)
`
`
`
`19. The end effector is configured to secure tissue between a pair of jaws,
`
`which is referred to as clamping. IS-1001 at 5:38-41. One of the jaws is
`
`configured to hold a staple cartridge with a plurality of staples, while the opposing
`
`jaw, which can be referred to as an anvil, has staple-forming pockets aligned with
`
`the rows of staples in the jaw comprising the staple cartridge. IS-1001 at 1:47-50
`
`(“One of the jaw members [i.e., the lower jaw] receives a staple cartridge having at
`
`
`
`8
`
`Ethicon Exhibit 2019.011
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`least two laterally spaced rows of staples. The other jaw member defines an anvil
`
`having staple-forming pockets aligned with the rows of staples in the cartridge.”).
`
`The staple cartridge can be removable, such that a single instrument can be used to
`
`fire multiple staple cartridges.
`
`20. The 749 Patent describes that a firing member can advance through
`
`the jaws of the end effector from a retracted position to a fired position. IS-1001 at
`
`7:39-58. The firing member 80 in a retracted position (Figure 5 and a fired
`
`position (Figure 6) is illustrated below:
`
`IS-1001 at Figures 5 and 6
`
`
`
`21.
`
` In an exemplary embodiment, the 749 Patent describes that the firing
`
`member is an E-beam 80 that drives a sled having a camming surface that drives
`
`
`
`9
`
`Ethicon Exhibit 2019.012
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`the staples out of the staple cartridge, which causes the staples to deform against
`
`the anvil to secure the tissue. IS-1001 at 7:39-56. The 749 Patent further describes
`
`that a cutting surface can advance through the end effector to cut tissue after the
`
`tissue has been stapled. In an exemplary embodiment, a cutting surface along the
`
`distal end of the E-beam cuts the tissue once stapled. IS-1001 at 7:56-58. A
`
`longitudinal view of an exemplary end effector from the 749 Patent is illustrated
`
`below, including the staple cartridge, channel (lower jaw), anvil (upper jaw), and
`
`E-beam firing member:
`
`IS-1001 at Figure 2 (annotations in red)
`
`
`
`
`A.
`
`Firing Drive
`
`10
`
`
`
`Ethicon Exhibit 2019.013
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`22. Claim 1 of the 749 Patent requires that the firing member “is movable
`
`from a retracted position to a fired position in response to a longitudinal firing
`
`motion applied thereto.” Claim 1 further requires that a firing drive “selectively
`
`generate said longitudinal firing motion upon actuation of a firing trigger operably
`
`coupled to said handle assembly.” As described in more detail below, a “drive” is
`
`a well-known term in the mechanical arts, which refers to a class of structures that
`
`transfer power from one part of a system to another. Drives can include well-
`
`known components such as shafts, racks, gears, and cables. The 749 Patent
`
`describes an exemplary firing drive, which comprises a linked rack. A side view
`
`of an exemplary instrument disclosed in the 749 Patent is shown below displaying
`
`a firing trigger 34, linked rack, and firing rod 32:
`
`
`
`11
`
`Ethicon Exhibit 2019.014
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`IS-1001 at Figure 9 (annotations in red)
`
`
`
`The figure below provides an exploded view of an exemplary firing drive, and
`
`illustrates the linked rack in relation to the firing rod 32:
`
`
`
`12
`
`Ethicon Exhibit 2019.015
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`IS-1001 at Figure 10 (annotations in red)
`
`
`
`23. Upon actuation of the firing trigger, the firing drive advances distally
`
`toward the end effector. IS-1001 at 3:32-36, 10:24-42. Distal movement of the
`
`firing drive (e.g., the linked rack and firing rod) causes a firing bar to advance the
`
`firing member distally through the end effector. See IS-1001 at 7:39-42 (“proximal
`
`end of a firing bar 76 that moves with the frame 28, specifically within guide 78
`
`therein, to distally project an E-beam firing member 80 into the end effector 12”).
`
`As described above, advancement of the firing member through the end effector
`13
`
`
`
`Ethicon Exhibit 2019.016
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`causes the ejection of staples and cutting of tissue. See IS-1001 at 7:39-58. An
`
`exploded view of the components of an exemplary shaft assembly and end effector
`
`from the 749 Patent is illustrated below, including an E-beam 80, firing bar 76 and
`
`firing rod 32:
`
`IS-1001 at Figure 4
`
`
`B. Retraction Assembly
`24. The exemplary firing member described in the 749 Patent engages
`
`
`
`both jaws of the end effector as it advances distally, which affirmatively spaces the
`
`jaws to assure proper staple formation. IS-1001 at 8:3-18 (“The top pin 110 of the
`
`E-beam 80 is aligned with an anvil slot 114 in the anvil 14 distal to and
`
`
`
`14
`
`Ethicon Exhibit 2019.017
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`communicating with the anvil pocket 112. In FIG. 6, the E-beam 80 has been fully
`
`fired, with the upper pin 110 translating down the anvil slot 114, affirmatively
`
`spacing the anvil 14 from the elongate channel 16 as the cutting surface 104 severs
`
`clamped tissue.”). Accordingly, the jaws cannot be re-opened until the firing
`
`member is fully retracted to its proximal position in the end effector. This
`
`mandates an effective mechanism for assuring that the firing member can fully
`
`retract after each use.
`
`25. Accordingly, Claim 1 of the 749 Patent also requires “a retraction
`
`assembly supported by said handle assembly and interfacing with said firing drive
`
`such that manual actuation of said retraction assembly causes said firing drive to
`
`generate a sole retraction motion which is communicated to said firing member to
`
`cause said firing member to move from said fired position to said retracted
`
`position.” The specification of the 749 Patent defines a “sole retraction motion” as
`
`a motion generated by manipulation of a retraction member without any assistance
`
`from additional springs or force generating members. IS-1001 at 16:23-28 (“Thus,
`
`the various retraction systems disclosed herein are said to generate the ‘sole’
`
`retraction motion or force. This means that the retraction motions/forces are
`
`generated by manipulation of the various retraction members by the clinician
`
`without any assistance from additional springs or force generating members.”).
`
`The 749 Patent describes that a retraction assembly that can generate a sole
`
`
`
`15
`
`Ethicon Exhibit 2019.018
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`retraction motion is particularly advantageous for articulating surgical instruments,
`
`where the force to fire the instrument may become excessive if a retraction spring
`
`is utilized:
`
`[T]he use of the retraction spring requires additional firing force to be
`generated to overcome the opposing spring force during firing. This problem
`can also be somewhat exacerbated when using articulating end effectors. In
`particular, when an articulating end effector is employed, a larger return
`spring must generally be employed to retract the articulating firing member.
`Use of such larger spring further increases the amount of firing forces that
`must be generated to overcome the spring force and fire the end effector
`components.
`IS-1001 at 2:57-65.
`
`26. The 749 Patent discloses several embodiments of a retraction
`
`assembly that enable the clinician to manually retract a firing member without the
`
`assistance of a spring or other force generating member that places a drag on the
`
`firing drive. In one embodiment, the retraction assembly can comprise, inter alia,
`
`a retraction lever and a gear. See e.g., IS-1001 at 14:31-15:24; see also id. at
`
`Figure 24. As illustrated below, the user can manually actuate a retraction handle
`
`in only one direction to retract the firing member from a fired position to a
`
`retracted position. IS-1001 at 15:13-17 (“To retract the firing rod 32, the clinician
`
`simply pushes the retraction handle in the “H” direction until the second gear rack
`
`
`
`16
`
`Ethicon Exhibit 2019.019
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`800 reaches the position illustrated in FIG. 26 wherein the grip portion 930 is
`
`adjacent the handle housing 154.”). This embodiment is illustrated below:
`
`
`
`IS-1001 at Figure 24
`
`
`
`
`
`IS-1001 at Figure 27
`
`17
`
`
`
`Ethicon Exhibit 2019.020
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`27. An alternative embodiment includes a manual retraction lever, a
`
`locking pawl, and a gear train. IS-1001 at 12:59-13:6. To retract the firing
`
`member, the clinician sequentially depresses and releases the manual retraction
`
`lever, which causes a locking pawl to rotate clockwise and engage a gear 231 that
`
`rotates a second gear 230 also clockwise. IS-1001 at 12:55-64. The clockwise
`
`rotation of gear 230 causes gear 220 to rotate counterclockwise driving the linked
`
`rack 200 in the proximal direction retracting firing rod 32 to a fully retracted
`
`position. IS-1001 at 12:64-13:6. An exploded view of the components of an
`
`exemplary manual retraction assembly disclosed in the 749 Patent is shown below:
`
`
`IS-1001 at Figure 12 (annotations in red)
`
`
`
`18
`
`Ethicon Exhibit 2019.021
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`As illustrated in Figure 17, the user can manually actuate the retraction lever 42
`
`back and forth (as indicated by the arrow A below) to cause the firing drive (e.g.,
`
`linked rack 200) to generate a sole retraction motion that is applied to the firing
`
`member to move it from the fired position to the retracted position. See also IS-
`
`1001 at 12:64-13:6.
`
`IS-1001 at Figure 17 (annotations in red)
`
`
`
`28. The specification also describes other configurations of a retraction
`
`assembly. For example, it explains that the retraction assembly can comprise a
`
`lever and a gear or gears. See IS-1001 at 3:40-46 (“A first gear may be in
`
`meshing engagement with the linked rack and a retraction lever may be movably
`
`
`
`19
`
`Ethicon Exhibit 2019.022
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`supported by the handle assembly and may be configured to interface with the first
`
`gear such that actuation of the retraction lever applies the sole retraction
`
`motion or force to the first gear which thereby transfers the sole retraction
`
`motion to the linked rack.”), 13:44-48 (“[T]he instrument 10' includes a first
`
`gear 620 that is operably mounted to mesh with the toothed upper, left
`
`surfaces 222 of the linked rack 200.”); 14:15-21 (“As the retraction lever 642 is
`
`rotated in that direction, it causes the second gear 630 to also rotate in that
`
`direction. Because the second gear 630 is in meshing engagement with the first
`
`gear 620, the first gear 620 rotates…which draws the linked rack in the proximal
`
`direction until it reaches it starting-unfired position.”).
`
`VI. CLAIM CONSTRUCTION
`29.
`I have been informed that the claims of the 749 Patent should be
`
`construed in accordance with the ordinary and customary meaning of such claim as
`
`understood by one of ordinary skill in the art and the prosecution history pertaining
`
`to the patent . I have applied this standard in my analysis below.
`
`30.
`
`In addition, I understand that a patentee may express a claim
`
`limitation as a means or step for performing a specified function instead of
`
`claiming the limitation by its structure. I understand that claim terms that use this
`
`format are commonly referred to as “means plus function” limitations. I have been
`
`informed that when a patentee utilizes means plus function claim language, the
`
`
`
`20
`
`Ethicon Exhibit 2019.023
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`specification of the patent must provide a sufficient description such that a person
`
`of ordinary skill in the art would understand what structure corresponds to the
`
`claimed function. I have also been informed that when a claim term is determined
`
`to be a means plus function limitation, the scope of the claim is limited to the
`
`corresponding structure described in the specification for performing the claimed
`
`function, as well as its structural equivalents. I further understand that the
`
`corresponding structure should only include the structure necessary for performing
`
`the claimed function, and should not include structure described in a preferred
`
`embodiment that is unrelated to performing the claimed function.
`
`31.
`
`I have been informed that if a claim term uses the phrase “means for,”
`
`it creates a presumption that the claim term is a means plus function limitation. I
`
`have also been informed, however, that if the phrase “means for” is not recited in a
`
`claim limitation, then there is a presumption that the claim term at issue is not a
`
`means plus function limitation. I have been informed that this presumption can be
`
`overcome if the claim term fails to recite sufficiently definite structure or else
`
`recites function without reciting sufficient structure for performing that function. I
`
`understand that a claim term can recite sufficient structure if the words of the claim
`
`are understood by a person of ordinary skill in the art to have a sufficiently definite
`
`meaning as the name for structure.
`
`
`
`
`
`21
`
`Ethicon Exhibit 2019.024
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`A.
`“firing member”
`32. Claim 1 of the 749 Patent requires a “firing member.” See IS-1001 at
`
`Claim 1 (“a firing member” that “is movable from a retracted position to a fired
`
`position in response to a longitudinal firing motion applied thereto.”). I understand
`
`that Petitioner and Dr. Knodel have proposed construing “firing member” as a
`
`means-plus-function limitation, subject to 35 U.S.C. § 112(6). See IS-1003 at ¶¶
`
`40-42. According to Dr. Knodel, the corresponding structure is E-beam 80, which
`
`includes a three-pin design featuring an upper pin 110, a middle pin 106, and a
`
`lower pin 108.
`
`33. The construction of this term is not material to my analysis below.
`
`Accordingly, I have applied Dr. Knodel’s construction. In doing so, I do not agree
`
`that Dr. Knodel’s construction of “firing member” is correct, and reserve the right
`
`to address the meaning of this term at a later time.
`
`B.
` “retraction assembly”
`34. Claim 1 of the 749 Patent requires a “retraction assembly.” See IS-
`
`1001 at Claim 1 (“a retraction assembly supported by said handle assembly and
`
`interfacing with said firing drive such that manual actuation of said retraction
`
`assembly causes said firing drive to generate a sole retraction motion which is
`
`communicated to said firing member to cause said firing member to move from
`
`said fired position to said retracted position”). In the context of the 749 Patent, a
`
`
`
`22
`
`Ethicon Exhibit 2019.025
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`person of ordinary skill would understand a “retraction assembly” to mean an
`
`assembly configured to allow a user to manually retract the firing member, which
`
`does not include any springs or other retraction members that place a drag on the
`
`firing system. This construction is consistent with the specification of the749
`
`Patent, which describes “a retraction assembly” that is “configured to enable the
`
`surgeon to manually retract the firing bar 32 without any other assistance from
`
`springs or other retraction members that serve to place a drag on the firing system
`
`and which ultimately require the generation of higher firing forces to actuate the
`
`firing mechanism.” IS-1001 at 12:9-15; see also id. at 5:53-59 (describing the
`
`invention as “a unique and novel manually actuatable retraction mechanism for
`
`retracting the firing members without any assistance from a retraction spring or
`
`other retraction arrangement, the forces of which must be overcome during
`
`firing”).
`
`35. The specification of the 749 Patent further explains that the disclosed
`
`retraction assembly generates the “sole” retraction motion or force. IS-1001 at
`
`16:23-25 (“Thus, the various retraction systems disclosed herein are said to
`
`generate the ‘sole’ retraction motion or force.”). Sole retraction motion is defined
`
`in the specification as meaning that the retraction forces are generated by the
`
`clinician manually actuating the disclosed retraction members without assistance
`
`from any additional retraction spring or force generating members. IS-1001 at
`
`
`
`23
`
`Ethicon Exhibit 2019.026
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`16:25-28 (“This means that the retraction motions/forces are generated by
`
`manipulation of the various retraction members by the clinician without any
`
`assistance from additional springs or force generating members.”).
`
`36.
`
`I understand that Dr. Knodel has proposed construing “retraction
`
`assembly” as a means-plus-function limitation, subject to 35 U.S.C. § 112(6). See
`
`IS-1003 at ¶¶ 43-45. I disagree that “retraction assembly” should be construed as a
`
`means plus function limitation because claim 1 sets for sufficiently definite
`
`structure for a retraction assembly. First, claim 1 requires that the “retraction
`
`assembly is supported by said handle assembly,” which informs a person of
`
`ordinary skill that the retraction assembly is structurally located within or
`
`otherwise connected (directly or indirectly) to the handle assembly, so that the
`
`handle assembly can support it. Second, claim 1 requires that the retraction
`
`assembly “interfaces with the firing drive,” which provides further structure by
`
`describing its physical relationship to another component in the instrument—the
`
`firing drive. Third, claim 1 requires “manual actuation of said retraction
`
`assembly,” meaning that the retraction assembly must include a portion, such as a
`
`lever, knob, or handle, that a user can actuate to generate the retraction force.
`
`37.
`
`If “retraction assembly” is deemed a means plus function limitation,
`
`in my opinion the correct corresponding structure is a gear(s) and lever, as well as
`
`structural equivalents. For example, the specification describes that a first gear and
`
`
`
`24
`
`Ethicon Exhibit 2019.027
`Intuitive v. Ethicon
`IPR2019-00880
`
`PUBLIC VERSION
`
`
`
`
`
`lever can perform the functions of retracting (and interfacing with)2 the firing
`
`drive. See IS-1001 at 3:40-46 (“A first gear may be in meshing engagement with
`
`the linked rack and a retraction lever may be movably supported by t
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
