IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Frederick E. 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.: 11030-0049IPA
`
`
`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
`(GIORDANO AS PRIMARY REFERENCE)
`
`
`
`
`
`
`
`
`1
`
`IS 1005
`
`

`

`U.S. Patent No. 8,479,969
`
`TABLE OF CONTENTS
`
`
`
`I.
`
`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
`
` Giordano ................................................................................................... 12
` Shelton ...................................................................................................... 15
` Wallace ..................................................................................................... 18
` Tierney ...................................................................................................... 20
` Hueil ......................................................................................................... 23
`
`X. APPLICATION OF THE PRIOR ART TO THE ’969 PATENT ................ 23
`
` Claims 1-11 and 24 are invalid as obvious over Giordano in view
`of Wallace ................................................................................................. 23
` Claims 1-11 and 24 are invalid as obvious over Giordano in view
`of Wallace and further in view of Tierney ............................................. 102
` Claims 1-6 and 9-10 are invalid as obvious over Shelton in view of
`Wallace and Tierney ............................................................................... 103
` Claims 7, 8, 11, and 24 are invalid as obvious over Shelton in view
`of Giordano and further in view of Wallace and Tierney ...................... 103
` Claims 5 and 6 are invalid as obvious over Giordano in view of
`Wallace and Tierney, and further in view of Hueil ................................ 104
`
`XI. CONCLUSION ............................................................................................ 107
`
`
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`2
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`U.S. Patent No. 8,479,969
`
`
`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
`
`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:
`
`
`
`
`
`IS1014
`
`U.S. Patent App. No. 2008/0167672 to Giordano et al.
`(“Giordano”)
`
`IS1008
`
` U.S. Patent No. 6,699,235 to Wallace et al. (“Wallace”)
`
`1
`
`3
`
`

`

`U.S. Patent No. 8,479,969
`
`IS1009
`
`U.S. Patent No. 6,331,181 to Tierney et al. (“Tierney”)
`
`IS1015
`
`U.S. Patent No. 6,978,921 to Shelton et al. (“Shelton”)
`
`IS1016
`
`U.S. Patent App. No. 2007/0158385 to Hueil et al.
`(“Hueil”)
`
`I have been asked to provide my technical review, analysis, insights
`
`
`
`
`
` 
`
`
`
`5.
`
`and opinions regarding the ’969 Patent and the above-noted references.
`
`
`
`QUALIFICATIONS
`
`6. 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.
`
`7.
`
`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.
`
`8.
`
`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.
`
`9.
`
`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
`
`2
`
`4
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`

`U.S. Patent No. 8,479,969
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`“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.
`
`10. Beginning in 1998, I have been a consultant for medical device
`
`companies and law firms. I have consulted in the areas of conceptual design,
`
`prototyping, and turnkey product design.
`
`11.
`
`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,
`
`GERD, bariatrics, CABG, heart valve repair, hernia, general surgical procedures,
`
`and surgical stapling, which is the general subject matter of the patent-at-issue.
`
`12. 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.
`
`3
`
`5
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`U.S. Patent No. 8,479,969
`
`13.
`
`I have not testified as an expert witness at trial or by deposition during
`
`the previous four years.
`
`14.
`
`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
`
`15.
`
`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
`
`16.
`
`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
`
`technical experts in forming opinions regarding meaning and validity of patent
`
`claims.
`
`4
`
`6
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`U.S. Patent No. 8,479,969
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`17. 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
`
`following:
`
`
`
`
`
`
`
`the levels of education and experience of persons working in the field;
`
`the types of problems encountered in the field; and
`
`the sophistication of the technology.
`
`18.
`
`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.
`
`19.
`
`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.
`
`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
`
`5
`
`7
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`

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`U.S. Patent No. 8,479,969
`
`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.
`
`20.
`
`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.
`
`21.
`
`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.
`
`22.
`
`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.
`
`23.
`
`I understand that an obviousness analysis should (1) identify the
`
`particular references that, singly or in combination, make the patent obvious; (2)
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`6
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`8
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`U.S. Patent No. 8,479,969
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`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.
`
`24.
`
`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 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.
`
`25. 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
`
`would improve similar devices in the same way, using the technique is obvious
`
`unless its actual application is beyond that person’s skill.”
`
`7
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`9
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`U.S. Patent No. 8,479,969
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` LEVEL OF ORDINARY SKILL IN THE ART
`
`26. A person of ordinary skill in the art at the time of the alleged invention
`
`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.
`
`27.
`
`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 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 ’520 patent.
`
` OVERVIEW OF THE ’969 PATENT
`
`28. 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 original application filed in 2007—i.e.,
`
`Giordano. In 2011, the applicant filed a “continuation-in-part” application that
`
`added new material related to a robotic embodiment, essentially adapting the
`
`handheld surgical instruments disclosed in Giordano to work with then-existing
`
`surgical robot systems, such as those made by Intuitive Surgical. Each of the
`
`8
`
`10
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`

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`U.S. Patent No. 8,479,969
`
`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
`
`29. 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
`
`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
`
`9
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`11
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`

`U.S. Patent No. 8,479,969
`
`was well-known to those of skill in the art, as shown in the 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
`
`30. 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 (IS1014) that
`
`led to the ’520 Patent provides written description support for the challenged
`
`claims (nos. 19-26) of the ’969 Patent, and it is my opinion that it does not. In
`
`particular, each challenged claim of the ’969 Patent claims a “tool mounting
`
`
`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.
`
`10
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`12
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`

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`U.S. Patent No. 8,479,969
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`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.
`
`31. The grandparent ’807 Application (IS1014) 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 understand it to disclose – only a
`
`handheld “endoscopic surgical instrument” with a mention that the instrument may
`
`be used in “robotic-assisted surgery.” IS1014, ¶¶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.
`
`32. 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
`
`would be the date of the CIP application (the ’259 Application), which is May 27,
`
`11
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`13
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`U.S. Patent No. 8,479,969
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`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
`
`33. 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 understand them to be synonymous at least as used
`
`within the disclosure of the ’969 Patent.
`
`34. Beyond the clarification above, I see no reason that one of ordinary
`
`skill in the art would understand 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
`
` Giordano
`
`35. Giordano is the published grandparent application to which the ’969
`
`CIP patent claims priority. Giordano. It does not disclose the robotic
`
`embodiments of the ’969 Patent, but it does disclose the same hand-held, two
`
`12
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`14
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`U.S. Patent No. 8,479,969
`
`stroke cutting and fastening instrument 10 disclosed in the ’969 Patent. Compare
`
`Giordano with the ‘969 Patent. The Giordano instrument discloses a surgical
`
`stapler that can articulate about an articulation joint. Giordano also incorporates by
`
`reference various other patent applications for various features and thus the
`
`Giordano reference includes many different surgical stapler embodiments. For
`
`example, as shown below in Fig. 2 of Giordano, instrument 10 includes an
`
`articulation joint and an articulation control mechanism. Giordano, Fig. 2.
`
`Articulation control mechanism
`
`Articulation joint
`
`
`
`36. The surgical stapler has a firing mechanism to drive a knife and staple
`
`pusher through the stapler end effector (such as end effector 12 in FIG. 2). Figure
`
`7 illustrates an exemplary firing mechanism, which is gear-driven using rotary
`
`gears. Instrument 10 also includes a gear-driven rotary closure tube assembly, and
`
`an elongated shaft assembly that rotates and articulates the end effector. E.g.,
`
`Giordano, Figs. 2, 7. The rotary drive transmission of the rotary firing mechanism
`
`13
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`15
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`

`

`is shown in FIG. 7 and illustrates various gears to transmit rotary motion from the
`
`motor to the drive shafts to drive the knife and stapler components.
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`U.S. Patent No. 8,479,969
`
`Rotary drive
`transmission
`
`
`
`Giordano, Fig. 7. Giordano also discloses a closure tube assembly for closing the
`
`anvil. The closure tube has both proximal and distal portions (one on either side of
`
`an articulation joint). The closure tube assembly is part of Giordano’s elongated
`
`shaft assembly, along with the drive shafts, which provide the rotary motions to the
`
`knife for firing the stapler:
`
`14
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`16
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`U.S. Patent No. 8,479,969
`
`Drive shafts
`
`End effector
`
`Closure tube
`
`
`
`Giordano, Fig. 5.
`
`
`
`Shelton
`
`37. Giordano broadly and unequivocally states that it incorporates Shelton
`
`by reference because it “provides more details about such two stroke cutting and
`
`fastening instruments.” Giordano, ¶39. Thus, one or ordinary skill in the art
`
`would have understood Giordano to incorporate at least Shelton’s description of
`
`two stroke cutting and fastening instruments as though the text were copied into
`
`Giordano. One of ordinary skill in the art would have recognized that Shelton not
`
`only provides additional details about Giordano’s staplers, but also provides
`
`15
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`17
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`U.S. Patent No. 8,479,969
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`alterative embodiments of various structures, which may be useful and desirable
`
`depending on the goals of the instrument designer. One of ordinary skill in the art
`
`would have further recognized that aspects of the Shelton stapler could be
`
`combined with aspects of the Giordano staplers to create a composite stapler based
`
`on the teachings of Shelton and/or Giordano.
`
`38. Shelton discloses a hand-held, two stroke cutting and fasting
`
`instrument 10 (“the Shelton stapler”) that has gear-driven firing and closure
`
`mechanisms, a closure tube assembly, and an elongated shaft assembly that rotates
`
`the end effector. Shelton, Fig. 1. The Shelton transmission mechanism is depicted
`
`in FIG. 7.
`
`End effector
`
`Elongated shaft assembly
`
`
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`16
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`18
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`U.S. Patent No. 8,479,969
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`Gear driven firing
`and closing
`mechanisms
`
`Closure tube
`
`39.
`
`I understand that because Shelton is incorporated by reference into
`
`
`
`Giordano, Giordano should be treated as though it includes the Shelton disclosure.
`
`However, if Giordano is deemed not to disclose the Shelton subject matter, then it
`
`would have been obvious to a person of ordinary skill in the art to combine
`
`Giordano and Shelton to arrive at the same subject matter. One of ordinary skill in
`
`the art would have been motivated to combine Giordano and Shelton specifically
`
`because Giordano cites to Shelton (and indeed, incorporates it by reference). Such
`
`a person would have been motivated to modify Shelton to add the articulation
`
`mechanism of Giordano because, as I explain below, adding articulation improves
`
`a surgical instrument by increasing its degrees of freedom. Although Giordano
`
`17
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`19
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`U.S. Patent No. 8,479,969
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`discloses its own firing and closure mechanisms, one of ordinary skill in the art
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`would recognize that not all aspects of Giordano need be used together, and the
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`Giordano teachings related to articulation could be applied to Shelton without
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`taking all the other teachings of Giordano. As I explain below, one of ordinary
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`skill in the art would have known how to combine the various technical teachings
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`of the references and would have had reason to do so.
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`40.
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` One of ordinary skill in the art would also have been motivated to
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`modify Shelton to add the drive screw firing mechanism of Giordano because
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`using a drive screw allows for increased torque over a longitudinal mechanism and
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`thus offers improvements over the mechanism in Shelton. Thus, one of ordinary
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`skill in the art would have recognized that either or both of the articulation or drive
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`screw structures could be added to the Shelton stapler depending on the
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`requirements of the stapler designer.
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` Wallace
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`41. The Wallace reference teaches “a robotic surgical tool for use in a
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`robotic surgical system.” Wallace, Figs. 1, 2A; Abstract; 7:33-56. Wallace also
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`incorporates Tierney, which is the robotic surgical reference that the ’969 Patent
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`itself incorporates by reference. Accordingly, via the incorporation of Tierney,
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`Wallace and the ’969 Patent share a common disclosure concerning the surgical
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`robot components and the interface between the robot manipulator and the
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`U.S. Patent No. 8,479,969
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`detachable surgical tool. (’969 Patent, 23:35-37 (incorporating by reference U.S.
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`Pat. No. 7,524,320, which is a continuation of a division of the application that
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`issued as the Tierney patent and Wallace, 1:16-18.
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`42. Wallace also describes a surgical tool designed for attachment to a
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`surgical robot. The tool has a “tool base 62” which provides the interface to the
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`robot arm. Wallace explains: “The surgical tool 50 includes a rigid shaft 52 having
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`a proximal end 54, a distal end 56 and a longitudinal axis there between. The
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`proximal end 54 is coupled to a tool base 62. The tool base 62 includes an
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`interface 64 which mechanically and electrically couples the tool 50 to a
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`manipulator on the robotic arm cart.” Wallace, 7:33-56. The surgical tool also
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`includes an elongated shaft assembly that rotates and articulates an end effector.
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`Wallace, 7:57-65, 13:6-14:15, FIGs. 1, 30.
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`21
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`U.S. Patent No. 8,479,969
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`Tool base
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`Fig. 1
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` Tierney
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`43. Wallace broadly and unequivocally incorporates “the full disclose of”
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`Tierney by reference. Wallace, 1:10-41. Thus, one of ordinary skill in the art
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`would have understood Wallace to incorporate all of Tierney. Not only did the
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`’969 Patent incorporate Tierney as well, but the ’969 Patent includes figures of
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`surgical robot embodiments that are quite similar to the figures in Tierney. For
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`example, the basic robotic instrument shape, surgeon control unit, and manipulator
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`20
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`22
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`appear to have been largely copied from Tierney:
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`’969 Patent
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`Tierney
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`U.S. Patent No. 8,479,969
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`21
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`23
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`’969 Patent
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`Tierney
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`U.S. Patent No. 8,479,969
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`44. Because Wallace incorporates Tierney, it is as though Wallace
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`contains the Tierney disclosure. If Wallace is deemed not to disclose the Tierney
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`subject matter, then it would have been obvious to combine Wallace and Tierney.
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`One of ordinary skill in the art implementing the embodiments of Wallace would
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`have been motivated to combine them with Tierney for at least two reasons. First,
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`Wallace leaves many details concerning surgical robots to prior art references and
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`assumes that the reader is familiar with the cited prior art, including Tierney, and
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`therefore, one of ordinary skill in the art would look to Tierney for details
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`concerning the implementation of the surgical robot on which Wallace is based.
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`Wallace focuses on the articulation mechanism for a robotic surgical instrument
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`and teaches one of ordinary skill in the art that the robotic portions are disclosed in
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`detail elsewhere. Second, Wallace explicitly directs one of ordinary skill in the art
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`22
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`24
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`U.S. Patent No. 8,479,969
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`to Tierney and thus such a person would naturally be motivated to look to Tierney
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`for the information contained therein. Wallace, 1:10-12, 16-18.
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` Hueil
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`45. Hueil discloses a handheld surgical stapler that is very similar to the
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`Shelton and Giordano staplers. Like Shelton, Hueil discloses an articulating
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`surgical stapler with a knife bar. Hueil discloses an additional feature where the
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`knife bar and knife are different components. Hueil further explains the benefit of
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`such an arrangement, and thus suggests adding that feature to other prior art
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`surgical staplers, such as Shelton. Hueil explains that the knife bar may be made
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`of a laminate for increased bendability to accommodate articulation. One of
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`ordinary skill in the art would have recognized that the knife would not want to be
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`made this way because the knife should be stiff and not bend in the lateral
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`direction.
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` APPLICATION OF THE PRIOR ART TO THE ’969 PATENT
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` Claims 1-11 and 24 are invalid as obvious over Giordano in view
`of Wallace
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`46.
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`It appears that claims 1-11 and 24 basically take the prior art hand-
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`held surgical staplers disclosed in Giordano (and the incorporated Shelton
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`reference) and adapt them to work with prior art surgical robots, such as those
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`described in the patents assigned to Intuitive Surgical, the petitioner here. Such
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`adaptation would have been obvious to one of ordinary skill in the art, and in fact,
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`23
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`25
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`U.S. Patent No. 8,479,969
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`would have been expected. The surgical robot patents, such as those I discuss
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`here, are designed to work with a variety of surgical instruments and thus it would
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`have been expected, natural, and obvious to adapt prior art hand-held surgical
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`staplers, such as those disclosed in Giordano (and the ’969 Patent) for use with the
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`robotic systems. This adaptation would generally involve removing the handle
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`from the hand-held instrument and replacing it with a tool base, or tool mounting
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`portion,
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`47. For example, Giordano (which incorporates by reference the prior art
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`surgical stapler of Shelton), when adapted for use with a surgical robot as
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`suggested by Wallace (which incorporates the surgical robotic system of Tierney)
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`would produce the robotic surgical stapler disclosed and claimed in the ’969
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`Patent.
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`24
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`26
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`Giordano’s incorporation of Shelton Wallace’s incorporation of Tierney
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`U.S. Patent No. 8,479,969
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`Shelton, FIG. 22
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`Wallace, Fig. 4
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`’969 Patent, FIG. 26.
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`48.
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`I note that FIG. 26 discloses an articulation joint, which is not
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`illustrated in Shelton. However, each of Giordano, Wallace, and Tierney disclose
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`articulation of the end effector, and Giordano discloses articulation using a
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`proximal and distal spine portion, In addition, both Wallace and Tierney teach a
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`robotic system that couples to articulating surgical instruments and thus both teach
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`one of ordinary skill in the art that instruments adapted for use with the system