throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Shelton, IV
`Patent of:
`
`8,479,969
`U.S. Pat. No.:
`July 9, 2013
`Issue Date:
`Appl. Serial No.: 13/369,609
`Filing Date:
`Feb. 9, 2012
`Title:
`DRIVE INTERFACE FOR OPERABLY COUPLING A
`MANIPULATABLE SURGICAL TOOL TO A ROBOT
`
`
`
`Attorney Docket No.: 11030-0049IP5
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`DECLARATION OF DR. BRYAN KNODEL IN SUPPORT OF PETITION
`FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,479,969
`(ANDERSON AS PRIMARY REFERENCE)
`
`
`
`
`
`
`
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`1
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`IS 1004
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`

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`U.S. Patent No. 8,479,969
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`
`
`
`I.
`
`TABLE OF CONTENTS
`
`QUALIFICATIONS ........................................................................................ 2
`
`II. MY UNDERSTANDING OF CLAIM CONSTRUCTION ........................... 4
`
`III. LEGAL STANDARDS ................................................................................... 4
`
`IV. LEVEL OF ORDINARY SKILL IN THE ART ............................................. 8
`
`V. OVERVIEW OF THE ’969 PATENT ............................................................ 8
`
`VI. PROSECUTION HISTORY OF THE ’969 PATENT ................................... 9
`
`VII. THE ’969 PATENT’S PRIORITY DATE .................................................... 10
`
`VIII. INTERPRETATION OF THE ’969 PATENT CLAIMS AT ISSUE ........... 12
`
`IX. OVERVIEW OF THE ASSERTED PRIOR ART ........................................ 12
`
` Anderson .........................................................................................................12
`
` Cooper.............................................................................................................15
`
` Timm...............................................................................................................15
`
` Wallace ...........................................................................................................16
`
` Knodel.............................................................................................................18
`
` Viola ...............................................................................................................20
`
`X. APPLICATION OF THE PRIOR ART TO THE ’969 PATENT ................ 21
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`U.S. Patent No. 8,479,969
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` Ground 1: Anderson View of Cooper ............................................................21
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` Ground 2: Anderson in View of Timm ..........................................................41
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` Ground 3: Anderson in View of Timm and Wallace .....................................66
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` Ground 4: Anderson in View of Knodel ........................................................75
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` Ground 5: Anderson in View of Viola ...........................................................85
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`XI. CONCLUSION ............................................................................................. 96
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`U.S. Patent No. 8,479,969
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`
`I, Bryan Knodel, declare as follows:
`
`1.
`
`I have been engaged as an expert by Fish & Richardson P.C. on behalf
`
`of Intuitive Surgical, Inc. (“Petitioner”) for the above-captioned inter partes review.
`
`I understand that this proceeding involves United States Patent No. 8,479,969
`
`entitled “Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a
`
`Robot” by Frederick E. Shelton IV, filed February 9, 2012, and issued July 9, 2013
`
`(the “’969 Patent” or “’969”). I understand that the ’969 Patent is currently
`
`assigned to Ethicon LLC.
`
`2.
`
`I have reviewed and am familiar with the specification of the ’969
`
`Patent. I will cite to the specification using the following format (’969 Patent, 1:1-
`
`10). This example citation points to the ’969 Patent specification at column 1,
`
`lines 1-10.
`
`3.
`
`I have reviewed and am familiar with the file history of the ’969 Patent
`
`(“FH”). I understand that the file history is being provided as an exhibit in a
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`single PDF document. I will cite to the PDF pages when I cite to the file history.
`
`4.
`
`I have also reviewed the Petition for Inter Partes Review of the ’969
`
`Patent and am familiar with the following prior art used in the Petition:
`
`
`
`
`
`
`
`
`
`IS1007
`
`U.S. Patent No. 6,817,974 to Cooper et al. (“Cooper”)
`
`IS1008
`
`U.S. Patent No. 6,699,235 to Wallace et al. (“Wallace”)
`
`IS1009
`
`U.S. Patent No. 6,331,181 to Tierney et al. (“Tierney”)
`
`1
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`4
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`U.S. Patent No. 8,479,969
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`
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`
`
`
`
`
`
`
`
`IS1010
`
`U.S. Patent No. 6,783,524 to Anderson et al.
`(“Anderson”)
`
`IS1011
`
`U.S. Patent No. 7,510,107 to Timm et al. (“Timm”)
`
`IS1012
`
`U.S. Patent No. 5,465,895 to Knodel et al. (“Knodel”)
`
`IS1013
`
`U.S. Patent No. 5,954,259 to Viola et al. (“Viola”)
`
`I also considered U.S. Published Application No. 2008/0167672
`(IS1014), which is the grandparent application to the ’969 Patent
`(filed as U.S. Application No. 11/651,807 (“’807 Application”)).
`
`I have been asked to provide my technical review, analysis, insights and
`
`opinions regarding the ’969 Patent and the above-noted references.
`
`
`
`QUALIFICATIONS
`
`5. My resume is being provided with this Declaration. As indicated there,
`
`I have eight publications and I am a named inventor on over 130 patents for
`
`medical devices. I have extensive experience with surgical instruments, and
`
`surgical staplers in particular, which is the subject matter of the ’969 Patent.
`
`6.
`
`Specifically, I have been involved in the research and development,
`
`design, and manufacture of medical devices including surgical cutting and stapling
`
`devices since 1992, and am qualified to present the analysis provided in this declaration.
`
`7.
`
`I was employed in the Research and Development department as an
`
`engineer of Ethicon Endo-Surgery. I was the lead design engineer for endoscopic
`
`linear staplers/cutters. In this lead design engineer role, it was my responsibility to
`
`understand every aspect of these devices.
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`
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`U.S. Patent No. 8,479,969
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`8.
`
`One early patent of mine is U.S. Patent No. 5,465,895, entitled
`
`“Surgical Stapler Instruments,” and granted on November 14, 1995. This patent is
`
`referenced in the Background section of the ’969 Patent’s specification as
`
`“disclos[ing] an endocutter with distinct closing and firing actions,” but was not
`
`cited by the Examiner during prosecution. ’969 Patent, 2:13-16. The ’895 Patent
`
`states: “The present invention relates in general to surgical stapler instruments
`
`which are capable of applying lines of staples to tissue while cutting the tissue
`
`between those staple lines and, more particularly, to improvements relating to
`
`stapler instruments and improvements in processes for forming various
`
`components of such stapler instruments.” My ’895 Patent specifically discloses
`
`jaws that open and close and a gear-driven knife to cut stapled tissue. I am thus
`
`generally familiar with such mechanisms for surgical instruments.
`
`9.
`
`Beginning in 1998, I have been a consultant for medical device
`
`companies and law firms. I have consulted in the areas of conceptual design,
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`prototyping, and turnkey product design.
`
`10.
`
`In addition, I have worked on a variety of surgical products for use in
`
`a wide range of surgical procedures including female reproductive system, female
`
`incontinence, female pelvic floor dysfunction, lung volume reduction, colon,
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`GERD, bariatrics, CABG, heart valve repair, hernia, general surgical procedures,
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`and surgical stapling, which is the general subject matter of the patent-at-issue.
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`U.S. Patent No. 8,479,969
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`11. As part of my consulting practice, I have also acted as a non-testifying
`
`expert in a patent litigation case in the area of medical devices.
`
`12.
`
`I have not testified as an expert witness at trial or by deposition during
`
`the previous four years.
`
`13.
`
`I am being compensated at my usual and customary rate of $200/hour
`
`for my work on this case, plus reimbursement for actual expenses. My
`
`compensation is not contingent upon the conclusions I reach, the outcome of this
`
`inter partes review, or any litigation involving the ’969 Patent.
`
` MY UNDERSTANDING OF CLAIM CONSTRUCTION
`
`14.
`
`I understand that claim terms are read in light of the patent’s
`
`specification and file history as understood by a person of ordinary skill in the art
`
`at the time of the purported invention. I further understand that in an inter partes
`
`review proceeding of an unexpired patent, such as the ’969 Patent, the claim terms
`
`are to be given their broadest reasonable interpretation (“BRI”) consistent with the
`
`specification. I understand that constructions under the BRI standard should be at
`
`least as broad as constructions under the plain and ordinary meaning standard used
`
`in district court litigation.
`
` LEGAL STANDARDS
`
`15.
`
`I am not a lawyer and do not provide any legal opinions. Although I
`
`am not a lawyer, I have been advised that certain legal standards are to be applied by
`
`
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`U.S. Patent No. 8,479,969
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`technical experts in forming opinions regarding meaning and validity of patent
`
`claims.
`
`16. As part of this inquiry, I have been asked to consider the level of
`
`ordinary skill in the field that someone would have had at the time the claimed
`
`invention was made. In deciding the level of ordinary skill, I considered the
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`following:
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`
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`
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`
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`the levels of education and experience of persons working in the field;
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`the types of problems encountered in the field; and
`
`the sophistication of the technology.
`
`17.
`
`I understand that a claim is invalid if a single prior art reference
`
`(including information that the single prior art reference specifically incorporates by
`
`reference) discloses a claimed invention (the invention thus lacks novelty) or if the
`
`claim would have been obvious to one of ordinary skill in the art at the time of the
`
`purported invention based on the teachings of one or more prior art references.
`
`18.
`
`I understand that the time of the purported invention is the earliest
`
`possible effective filing date of the application that discloses the claimed subject
`
`matter. For the ’969 Patent, the filing date is February 9, 2012. The ’969 Patent
`
`claims priority as a continuation of application No. 13/118,259 (the “’259
`
`application”), filed on May 27, 2011, which is a continuation-in-part of application
`
`No. 11/651,807 (the “’807 application”), filed on Jan. 10, 2007 and issued as U.S.
`
`
`
`5
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`U.S. Patent No. 8,479,969
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`Patent No. 8,459,520 (“the ’520 patent”). I reviewed the ’807 application and saw
`
`no disclosure of a robotic instrument interface to a tool drive assembly having
`
`rotatable body portions, as required by the claims, and therefore I understand that
`
`the ’969 Patent cannot use the ’807 application’s filing date for an effective filing
`
`date. My understanding, therefore, is that the ’969 Patent has a priority date no
`
`earlier than May 27, 2011.
`
`19.
`
`I am informed that a claim can be invalid based on anticipation if each
`
`limitation of the claim is found in the four corners of a single prior art reference
`
`(including any incorporated material), either explicitly or inherently.
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`20.
`
`I am informed that a claim can be invalid based on obviousness in light
`
`of a single prior art reference alone (based on general knowledge in the art), or
`
`based upon a combination of prior art references, where there is some reason one
`
`of ordinary skill in the art would make the combination.
`
`21.
`
`I am informed that when evaluating whether an invention would have
`
`been obvious, the question is whether the differences between the subject matter
`
`sought to be patented and the prior art are such that the subject matter as a whole
`
`would have been obvious to a person of ordinary skill in the art at the time the
`
`purported invention was made. In other words, the question is not whether a single
`
`element “would have been obvious” but whether the claim as a whole would have
`
`been obvious given what was known in the prior art.
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`U.S. Patent No. 8,479,969
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`22.
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`I understand that an obviousness analysis should (1) identify the
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`particular references that, singly or in combination, make the patent obvious; (2)
`
`specifically identify which elements of the patent claim appear in each of the
`
`asserted references; and (3) explain a motivation, teaching, need or market pressure
`
`that would have inspired a person of ordinary skill in the art to combine prior art
`
`references to solve a problem. I understand that certain objective indicia should be
`
`considered, if available, regarding whether a patent claim would have been obvious
`
`or nonobvious. Such indicia include: commercial success of products covered by
`
`the patent claims; a long-felt need for the invention; failed attempts by others to
`
`make the invention; copying of the invention by others in the field; unexpected
`
`results achieved by the invention as compared to the closest prior art; praise of the
`
`invention by the infringer or others in the field; the taking of licenses under the
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`patent by others; expressions of surprise by experts and those skilled in the art at the
`
`making of the invention; and the patentee proceeded contrary to the accepted
`
`wisdom of the prior art. I am not aware of any such indicia that would be pertinent
`
`to the challenged claims.
`
`23. Furthermore, I understand that the United Sates Supreme Court in its
`
`KSR vs. Teleflex decision ruled that “if a technique has been used to improve one
`
`device, and a person of ordinary skill in the art would have recognized that it
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`U.S. Patent No. 8,479,969
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`would improve similar devices in the same way, using the technique is obvious
`
`unless its actual application is beyond that person’s skill.”
`
` LEVEL OF ORDINARY SKILL IN THE ART
`
`24. A person of ordinary skill in the art at the time of the alleged invention
`
`(“POSITA”) would have had the equivalent of a Bachelor’s degree or higher in
`
`mechanical engineering with at least 3 years working experience in the design of
`
`comparable surgical devices. Additional education in a relevant field, such as
`
`mechanical engineering or robotics (to the extent pertinent), or industry experience
`
`may compensate for a deficit in one of the other aspects of the requirements stated
`
`above.
`
`25.
`
`I am a person of at least ordinary skill in the art, and was such a person as
`
`of the priority date of the ’969 Patent, which I am informed by counsel that, for purposes
`
`of this petition, is May 27, 2011. I was also a person of at least ordinary skill in the
`
`art as of January 10, 2007, the filing date of the grandparent ’807 application.
`
` OVERVIEW OF THE ’969 PATENT
`
`26. The ’969 Patent’s specification generally has two parts. It first
`
`discusses a hand-held embodiment at length (at roughly columns 11-22), and this
`
`material generally comes from the grandparent ’807 application filed in 2007. In
`
`2011, the applicant filed a “continuation-in-part” application that added new
`
`material related to a robotic embodiment, essentially adapting the handheld
`
`
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`U.S. Patent No. 8,479,969
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`surgical instrument to work with then-existing surgical robot systems, such as
`
`those made by Intuitive Surgical. Each of the claims of the ’969 Patent concern
`
`the robotic embodiments as each requires a “tool mounting portion” to interface to
`
`“rotatable body portions” on a robotic “tool drive assembly.” ’969 Patent at 11:12-
`
`42; 23:50-24:39; accord ’969 Patent, Title. The robotic surgical systems disclosed
`
`and claimed by the ’969 Patent include components that were both typical and
`
`expected of systems in the art at the time of the priority date of the ’969 Patent.
`
`These components include a “master controller” and “robotic arm cart” and a tool
`
`drive assembly with multiple rotary drive members controlling surgical end
`
`effectors. ’969 Patent, 23:50-62; 24:62-25:29; FIGs. 26-27. Each of these
`
`components may be found in the prior art, and in particular the prior art of
`
`Petitioner Intuitive Surgical. Compare ’969 Patent, FIGs. 27 and 29 (“tool drive
`
`assembly”) with Tierney FIGs. 7J and 7E (Driven disks, receiving rotary drive
`
`motions from rotary drive elements on tool drive assembly of robotic surgical
`
`system).
`
` PROSECUTION HISTORY OF THE ’969 PATENT
`
`27. While the application that led to the ’969 Patent was pending, the
`
`Patent Office issued one and only one rejection, over Tierney, directed to two
`
`independent claims. FH at 280-284. The Patent Office also indicated that a
`
`number of dependent claims were allowable, FH at 284, and Applicant amended
`
`
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`U.S. Patent No. 8,479,969
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`the independent claims to include the subject matter identified as allowable. FH at
`
`295-310. However, as discussed below, the subject matter identified as allowable
`
`was well-known to those of skill in the art, as shown in Anderson, Cooper and the
`
`other references cited here. The Examiner then issued a notice of allowance, FH at
`
`328-330, and Patent Owner filed a request for continued examination containing
`
`over 2,000 new references on February 22, 2013. FH at 357-438, 471. A new
`
`Notice of Allowance followed two weeks later on March 7, 2013. FH at 547-552.
`
` THE ’969 PATENT’S PRIORITY DATE
`
`28. As discussed above, the ’969 Patent claims priority as a continuation
`
`of application No. 13/118,259, filed on May 27, 2011, which is a continuation-in-
`
`part of application No. 11/651,807, filed on Jan. 10, 2007 and issued as the ’520
`
`Patent. I have not been asked to consider, and so have not considered, whether the
`
`parent ’259 Application provides written description support for the ’969 Patent.1 I
`
`have, however, considered whether the grandparent ’807 Application that led to the
`
`’520 Patent provides written description support for the challenged claims (nos.
`
`
`1 I understand that Intuitive has not conceded that any previously-filed application
`
`provides written description support for any claim of the ’969 Patent, but merely
`
`does not challenge the priority claim to the parent ’259 Application for purposes of
`
`this Petition.
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`13
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`U.S. Patent No. 8,479,969
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`19-26) of the ’969 Patent, and I have concluded that it does not. In particular, each
`
`challenged claim of the ’969 Patent claims a “tool mounting portion” “being
`
`configured to operably interface with the tool drive assembly” and further recites
`
`that the “tool drive assembly” is part of a robotic system. ’969 Patent, 88:13-
`
`96:60. The claims also recite that the recited instrument has components that
`
`interface with “rotatable body portions” on the robotic tool drive assembly.
`
`29. The grandparent ’807 Application does not disclose, and one of
`
`ordinary skill at the time of the priority date of the ’969 Patent would not have
`
`understood the ’807 Application to disclose, these limitations. Rather, it discusses
`
`– and thus one of ordinary skill in the art would have understood it to disclose –
`
`only a “handheld endoscopic surgical instrument” with a mention that the
`
`instrument may be used in “robotic-assisted surgery.” ’807 Application, ¶¶15, 89,
`
`FIGs. 1-2. There is no disclosure in the ’807 Application of the details of any
`
`surgical robot and no mention of the tool drive assembly, the tool mounting
`
`portion, or the rotatable body portions on the tool drive assembly. A person of
`
`skill in the art would not understand the inventors to have possession of the alleged
`
`invention of the challenged claims prior to the filing of the 2011 application.
`
`30. Because the ’807 Application does not disclose the robotic limitations
`
`of the claims, I understand that the ’969 Patent is not entitled to the filing date of
`
`the ’807 Application, and thus the earliest possible filing date the ’969 Patent
`
`
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`11
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`U.S. Patent No. 8,479,969
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`would be the date of the ’259 Application, which is May 27, 2011. Again, I offer
`
`no opinion as to whether the parent ’259 Application provides written description
`
`support for any claim of the ’969 Patent, and understand that the burden to show
`
`such a disclosure in an alleged priority document falls on the patentee.
`
` INTERPRETATION OF THE ’969 PATENT CLAIMS AT ISSUE
`
`31. As a preliminary matter, I observe that the ’969 Patent uses the terms
`
`“instrument” and “tool” interchangeably. E.g., ’969 Patent, Title, Abstract, 1:54-
`
`65, 2:21-24, 2:50-3:2, 3:6-22, 3:66-4:3, 4:10-20, 10:64-11:42, 24:11-43. The
`
`specification does not describe any difference between these terms, and one of
`
`ordinary skill in the art would have understood them to be synonymous at least as
`
`used within the disclosure of the ’969 Patent.
`
`32. Beyond the clarification above, I see no reason that one of ordinary
`
`skill in the art would have understood the broadest reasonable interpretation of the
`
`terms of the challenged claims of the ’969 Patent to require clarification beyond
`
`the plain meaning of those terms.
`
` OVERVIEW OF THE ASSERTED PRIOR ART
`
` Anderson
`
`33. Anderson (U.S. Patent No. 6,783,524 assigned to petitioner, Intuitive
`
`Surgical, Inc.) describes a surgical robot, and is assigned to Intuitive Surgical, the
`
`Petitioner here. The surgical robot in Anderson is specifically designed to
`
`interface with a variety of surgical instruments, such as surgical staplers, tissue
`
`
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`12
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`U.S. Patent No. 8,479,969
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`graspers, and tissue cutters. Anderson, 7:6-25; 11:32-65; 16:25-36; FIGs. 2-3;
`
`12A-D. Anderson describes a surgical robot of the same type as that disclosed in
`
`the Tierney reference considered by the Examiner and referenced in the ’969
`
`Patent, and further contains additional disclosure pertinent to the ’969 Patent
`
`claims. Anderson discloses that its system is for use with surgical tools similar to
`
`those described in the ’969 Patent and depicts surgical tools which have end
`
`effectors that can be rotated by either a cable drum or gear configuration.
`
`Specifically, Anderson’s surgical tool comprises an end effector connected via an
`
`elongate shaft to a base which mounts the tool to a robotic surgical system.
`
`Anderson FIG. 2, 11:32-65. Anderson’s shaft rotates about the longitudinal axis
`
`shown in FIG. 2. Anderson’s end effector may include, for example, a pivotable
`
`gripper for gripping tissue. Anderson 15:30-60. Anderson’s base has a plurality of
`
`“transmission members” that transmit rotational motion from a robotic arm to the
`
`end effector. Anderson 11:66-12:22; 16:7-23. Anderson teaches an end effector
`
`that may be rotated using a cable-driven system, and also discloses “a gear train”
`
`that may be used, and, in particular, “a right-angled helical gear pair.” Anderson
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`16:37-46; 23:25-36.
`
`34. Also of note is that the figures of the ’969 Patent have a striking
`
`resemblance to those of the prior-art Anderson reference:
`
`
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`13
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`16
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`U.S. Patent No. 8,479,969
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`Robotic Controller
`
`’969 Patent
`
`Anderson
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`
`
`
`
`
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`Robotic Manipulator
`
`’969 Patent
`
`Anderson
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`U.S. Patent No. 8,479,969
`
`Surgical Tool With Proximal Tool Holder
`
`’969 Patent
`
`Anderson
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`
`
`
`
`
`
` Cooper
`
`35. Cooper (U.S. Patent No. 6,817,974 also assigned to petitioner,
`
`Intuitive Surgical, Inc.) discloses a surgical tool, such as a stapler, for surgical
`
`robots similar to that of Anderson, with a focus on various articulating wrists.
`
`Cooper at FIG. 36; 17:26-50. In addition, Cooper has a figure depicting a gear-
`
`driven embodiment in which a helical gear pair, including a tube gear, is used to
`
`rotate the shaft and end effector. Cooper at FIG. 64; 24:1-23.
`
` Timm
`
`36. Timm discloses a surgical stapler with an articulation joint. Timm,
`
`2:25-55; 1:42-53; Abstract, FIG 1. In particular, the surgical stapler of Timm
`
`discloses an elongate shaft with articulation ball joint 2760, a proximal spine
`
`segment 2720 on one side of the ball joint, and a distal spine segment 2740 on the
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`15
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`U.S. Patent No. 8,479,969
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`other, where the spine and end effector may be “removably associated with” a
`
`“robotic or computer” actuator. Timm, FIG. 52; 28:50-29:3; see also FIGs. 62-66;
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`8:3-7; 12:1-3; 28:45-49; 31:62-32:31; 30:58-31:35. Timm also discloses a gear-
`
`driven knife that is selectively movable with respect to the lower jaw of the stapler.
`
`E.g., Timm, Abstract
`
` Wallace
`
`37. The Wallace reference (U.S. Patent No. 6,699,235 also assigned to
`
`petitioner, Intuitive Surgical, Inc.) teaches a “robotic surgical tool for use in a
`
`robotic surgical system” that, similar to the instruments of Anderson, includes a
`
`shaft supporting a surgical end effector with a “tool base 62 [that] includes an
`
`interface 64 which mechanically and electrically couples the tool 50 to a
`
`manipulator on the robotic arm cart.” Wallace, FIGs. 1, 2A; Abstract; 7:33-56:
`
`
`
`16
`
`19
`
`

`

`U.S. Patent No. 8,479,969
`
`38. Wallace also teaches a “wrist joint or mechanism” operated by
`
`
`
`
`
`moving articulation rods using gears, as shown in Figure 30. Wallace, 7:57-65;
`
`13:6-14:15, FIG. 30 (including “sector gears 312” and “gears 400”).
`
`
`
`17
`
`20
`
`

`

`U.S. Patent No. 8,479,969
`
`
`
` Knodel
`
`39. Knodel teaches “[a] surgical stapler instrument … for applying lateral
`
`lines of staples to tissue while cutting the tissue between those staple lines.”
`
`Knodel, Abstract. The surgical instrument of Knodel also has a shaft that supports
`
`an end effector, as may be seen in FIG. 1:
`
`
`
`18
`
`21
`
`

`

`U.S. Patent No. 8,479,969
`
`Knodel, FIG. 1; 5:52-6:10. Knodel also teaches a shaft supporting a drive bar that
`
`it refers to as “drive member 164” and which moves distally within the shaft
`
`thereby imparting driving force on wedge work member 162 and knife 161 as
`
`shown in FIG. 2:
`
`
`
`
`
`19
`
`22
`
`

`

`U.S. Patent No. 8,479,969
`
`Knodel, FIG. 2; 9:10-17; 10:65-11:12; 10:10-18; see also FIG. 6; 10:65-11:12;
`
`
`
`9:10-35.
`
` Viola
`
`40. Viola discloses a surgical stapling tool with an end effector stapler
`
`that uses a drive screw. The end effector of Viola may be attached via “J-shaped
`
`engagement slot 156 formed in body portion 14”:
`
`
`
`20
`
`23
`
`

`

`U.S. Patent No. 8,479,969
`
`Viola, 7:44-45, Fig. 2a.
`
`41. Viola also discloses an end effector that can be rotatably attached to
`
`the elongated shaft using “engagement pins 158a and 158b”:
`
`
`
`
`
`Viola, 7:46, Fig. 10.
`
` APPLICATION OF THE PRIOR ART TO THE ’969 PATENT
`
` Ground 1: Anderson View of Cooper
`
`42. Claim 23 of the ’969 Patent would have been obvious to one of
`
`ordinary skill in the art over Anderson taken in view of Cooper. For example,
`
`
`
`21
`
`24
`
`

`

`U.S. Patent No. 8,479,969
`
`Anderson discloses all limitations of claim 23 except for an explicit disclosure of a
`
`“tube gear” for rotating the end effector. Cooper discloses the tube gear.
`
`43.
`
`I note that although Anderson was before the Examiner during
`
`prosecution, it was not used in any rejection and there is no evidence in the
`
`prosecution record that the Examiner considered Anderson in connection with the
`
`Cooper reference. I examine each limitation of the relevant claims of the ’969
`
`Patent and I discuss the motivation to combine Anderson with Cooper. One of
`
`skill in the art would have readily understood that supplementing Anderson’s
`
`disclosure with details from Cooper concerning Cooper’s helical drive and tube
`
`gears is merely the application of a known technique (generate shaft rotation by
`
`using tube gears) to a known system (e.g., the surgical instrument of Anderson
`
`which has a gear option) ready for improvement to yield predictable results.
`
`44. One of skill in the art would find many reasons to modify Anderson to
`
`include the gear arrangement of Cooper. First, one of skill in the art would have
`
`understood that the gear structure of Cooper and Anderson’s disclosure of a “right-
`
`angled helical gear pair” are extremely similar. Anderson, 22:59-23:30. Indeed,
`
`one of skill in the art would have been motivated to replace Anderson’s spool 94
`
`and roll drum 96 with Cooper’s helical drive gear 840 and follower gear 842
`
`because Anderson specifically discloses that the pictured roll drum/spool pair
`
`shown in FIG. 13 may be replaced by a “right-angled helical gear pair.” Anderson,
`
`
`
`22
`
`25
`
`

`

`U.S. Patent No. 8,479,969
`
`22:59-23:30.
`
`45. One of skill in the art would recognize that Cooper discloses that its
`
`teachings would result in “improved efficiency and cost-effectiveness” over
`
`conventional way of conveying motion, Cooper, 24:21-23, and one of skill in the
`
`art would apply the gear arrangement of Cooper into the system taught by
`
`Anderson to achieve these benefits. In addition, the gear arrangement of Cooper
`
`can provide greater torque than the arrangement of Anderson, which would have
`
`served to reduce the size and possibly expense of the motor required. In addition,
`
`Cooper’s gear structure is significantly less complex than the cable embodiment
`
`and related components. Anderson, 22:59-23:30.
`
`46. Finally, one of skill in the art would have modified the teachings of
`
`Anderson to include the teachings of Cooper because both teach surgical
`
`instruments that may be releasably attached to a robotic surgical system that may
`
`provide rotational driving motion, and thus modifying Anderson as I describe here
`
`would have led to predictable results without significantly altering or hindering the
`
`functions performed by Anderson’s system. Indeed, Anderson teaches that
`
`“various alternatives, modifications and equivalents may be used” and Cooper
`
`suggests such an improvement. Anderson at 25:10-11.
`
`
`
`23
`
`26
`
`

`

`U.S. Patent No. 8,479,969
`
`1.
`
`[23.P] A surgical tool for use with a robotic system that has a
`tool drive assembly that is operatively coupled to a control
`unit of the robotic system that is operable by inputs from an
`operator and is configured to provide at least one rotary
`output motion to at least one rotatable body portion supported
`on the tool drive assembly, said surgical tool comprising:
`
`47. One of ordinary skill in the art would have understood Anderson to
`
`disclose this limitation.
`
`48. Regarding the phrase “[a] surgical tool for use with a robotic system,”
`
`Anderson teaches “a robotic surgical instrument for use with a robotic surgical
`
`system,” and that “surgical instrument 28” is “configured to releasably engage a
`
`robotic surgical system”, which may be viewed in Figure 2:
`
`Anderson, FIG. 2; 16:7-23; 11:32-42; 10:65-11:31; 4:7-11; Abstract.
`
`49. Regarding the phrase “has a tool drive assembly that is operatively
`
`coupled to a control unit,” Anderson teaches “control station 12” that controls
`
`“surgical workstation” 20 which has the surgical tool drive assembly and attendant
`
`
`
`
`
`24
`
`27
`
`

`

`U.S. Patent No. 8,479,969
`
`surgical tools, and one of skill in the art would have understood that the control
`
`station corresponds to the “control unit” claimed by the ’969 Patent. Anderson,
`
`FIG. 1; 10:21-64. This may be seen below:
`
`
`
`50. Regarding the phrase “operable by inputs from an operator,” control
`
`station 12 may be operated by “operator control input” from “a surgeon or other
`
`user.” Anderson, 10:40-64; 11:59-65; 5:61-6:8.
`
`51. Regarding the phrase “configured to provide at least one rotary output
`
`motion to at least one rotatable body portion supported on the tool drive
`
`assembly,” one of ordinary skill in the art would have understood that the
`
`Anderson manipulator has motors that drive rotating “engaging members” which
`
`drive shafts 70.1, 72.1, 74.1, and 76.1 on the attached instrument, as disclosed by
`
`
`
`25
`
`28
`
`

`

`Anderson:
`
`U.S. Patent No. 8,479,969
`
`
`
`Anderson, FIG. 3 (in red). Anderson teaches that the above base 34 attaches to a
`
`robotic arm assembly 26, including its motors and engaging members that attach to
`
`and apply rotary motion to the above shafts. Anderson, FIG. 3; 11:66-12:22;
`
`Abstract. Anderson teaches that the engaging members have rotary motion applied
`
`by “actuators,” which may include “electric motors or the like, to cause selective
`
`angular displacement of each engaging member” to the interface of the rotatable
`
`shafts within base 34. Anderson, FIG. 3; 11:66-12:22; Abstract. For these
`
`reasons, one of ordinary skill in the art would have readily understood that
`
`Anderson teaches “rotatable body portions supported on the tool drive assembly.”
`
`2.
`
`[23.1] a surgical end effector comprising at least one
`component portion that is selectively movable between first
`and second positions re

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