IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Christopher J. Schall, et al.
`In re Patent of:
`7,490,749
`U.S. Patent No.:
`February 17, 2009
`Issue Date:
`Appl. Serial No.: 11/729,355
`Filing Date:
`March 28, 2007
`Title:
`SURGICAL STAPLING AND CUTTING INSTRUMENT WITH
`MANUALLY RETRACTABLE FIRING MEMBER
`
` Attorney Docket No.: 11030-0052IP1
`
`DECLARATION OF BRYAN KNODEL
`
`1
`
`IS 1003
`
`
`
`Christopher J. Schall, et al.
`In re Patent of:
`7,490,749
`U.S. Patent No.:
`February 17, 2009
`Issue Date:
`Appl. Serial No.: 11/729,355
`Filing Date:
`March 28, 2007
`Title:
`SURGICAL STAPLING AND CUTTING INSTRUMENT WITH
`MANUALLY RETRACTABLE FIRING MEMBER
`
` Attorney Docket No.: 11030-0052IP1
`
`DECLARATION OF BRYAN KNODEL
`
`1
`
`IS 1003
`
`
`
`U.S. Patent No. 7,490,749
`
`TABLE OF CONTENTS
`
`QUALIFICATIONS ........................................................................................ 4
`
` MY UNDERSTANDING OF CLAIM CONSTRUCTION ........................... 6
`
` MY UNDERSTANDING OF CERTAIN LEGAL STANDARDS ................ 7
`
` LEVEL OF ORDINARY SKILL IN THE ART ........................................... 10
`
` OVERVIEW OF CONCLUSIONS ............................................................... 10
`
` OVERVIEW OF THE ’749 PATENT .......................................................... 12
`
`
`
`INTERPRETATION OF THE ’749 PATENT CLAIMS AT ISSUE ........... 21
`
` OVERVIEW OF THE ASSERTED PRIOR ART ........................................ 29
`
` Shelton II .................................................................................................. 29
` Swayze ...................................................................................................... 41
` Shelton I .................................................................................................... 47
`
` APPLICATION OF THE PRIOR ART TO THE ’749 PATENT ................ 54
`
` Shelton II .................................................................................................. 54
` Swayze ...................................................................................................... 72
` Shelton I .................................................................................................... 75
`
`
`
`CONCLUSION ............................................................................................ 100
`
`
`
`
`
`
`
`
`2
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`
`
`U.S. Patent No. 7,490,749
`
`
`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. 7,490,749
`
`entitled “Surgical Stapling and Cutting Instrument With Manually Retractable
`
`Firing Member” attributed to inventors Christopher J. Schall and Chad P.
`
`Boudreaux, filed March 28, 2007 and issued February 17, 2009 (the ’749 Patent). I
`
`understand that the ’749 is currently assigned to Ethicon LLC.
`
`2.
`
`I have reviewed and am familiar with the specification of the ’749
`
`Patent. I will cite to the specification using the following format (’749 Patent, 1:1-
`
`10). This example citation points to the ’749 Patent specification at column 1,
`
`lines 1-10. I also have reviewed and am familiar with the file history of the ’749
`
`Patent IS1002).
`
`3.
`
`I have also reviewed the Petition for inter partes Review of the ’749
`
`Patent and am familiar with the following prior art used in the Petition:
`
`
`
`
`
`
`
`IS1004
`
`
`IS1005
`
`
`IS1006
`
`
`U.S. Patent Publication No. 2006/0175375 to
`Shelton et al. (“Shelton II”)
`
`U.S. Patent Publication No. 2005/0178813 to
`Swayze et al. (“Swayze”)
`
`U.S. Patent No. 8,322,455 to Shelton et al.
`(“Shelton I”)
`
`
`
`3
`
`
`
`4.
`
`I have also reviewed the documents listed below, which I refer to
`
`throughout this Declaration.
`
`U.S. Patent No. 7,490,749
`
`
`
`
`
`
`
`
`
`
`
`IS1008
`
`
`
`
`IS1009
`
`
`
`How Design Teams Use DFM/A to Lower Costs
`and Speed Products to Market (1996) (retrieved
`from http://www.ame.org/sites/default/files/target
`_articles/96q1a2.pdf)
`
`Electronic Comparison of Written Description of
`Swayze (US 2005/0178813; Original) to Shelton II
`(US 2006/0175375; Underline/Strikethrough)
`
`IS1010
`
`U.S. Patent No. 5,941,442
`
`IS1011
`
`U.S. Patent No. 5,865,361
`
`IS1012
`
`
`Excerpts from McGraw-Hill Dictionary of
`Scientific and Technical Terms (6th Edition, 2003)
`
`5.
`
`I have been asked to provide my technical review, analysis, insights
`
`and opinions regarding the ’749 Patent and the above-noted references.
`
`
`
`QUALIFICATIONS
`
`6. My curriculum vitae 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 ’749 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.
`
`
`
`4
`
`
`
`U.S. Patent No. 7,490,749
`
`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 ’749 Patent’s specification as “an
`
`example of a surgical stapler . . . which advantageously provides distinct closing
`
`and firing actions.” ’749 Patent, 2:13-16. My ’895 Patent states (at 1:1-10):
`
`“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.”
`
`Similar to the ’749 Patent, the surgical instrument described in my ’895 Patent
`
`includes a pistol-grip handle assembly supporting a stapling and severing end
`
`effector at the distal end of an elongate shaft assembly, with manually operated
`
`firing and closure triggers. I am thus quite familiar with such mechanisms for
`
`surgical instruments.
`
`
`
`5
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`
`
`U.S. Patent No. 7,490,749
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`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 both a
`
`testifying and non-testifying expert in certain patent proceedings in the area of
`
`medical devices. These matters are listed in my CV.
`
`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 ’749 Patent.
`
` MY UNDERSTANDING OF CLAIM CONSTRUCTION
`
`14.
`
`I understand that, subject to certain exceptions, claim terms are
`
`generally given their plain and ordinary meaning 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.
`
`
`
`6
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`U.S. Patent No. 7,490,749
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` MY UNDERSTANDING OF CERTAIN 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
`
`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
`
`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.
`
`17.
`
`I understand that a claim is invalid if a single prior art 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 ’749 Patent, the filing date is March 28, 2007. My understanding
`
`is that the earliest possible effective filing date of the ’749 Patent is its actual filing
`
`
`
`7
`
`
`
`U.S. Patent No. 7,490,749
`
`date of March 28, 2007, because the ’749 Patent does not claim priority to any
`
`earlier filed applications.
`
`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,
`
`either explicitly or inherently.
`
`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.
`
`22.
`
`I understand that an obviousness analysis should (1) identify the
`
`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
`
`
`
`8
`
`
`
`U.S. Patent No. 7,490,749
`
`that would have inspired a person of ordinary skill in the art to combine prior art
`
`references to solve a problem.
`
`23.
`
`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.
`
`24. 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.”
`
`
`
`
`
`
`
`9
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`
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`U.S. Patent No. 7,490,749
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` LEVEL OF ORDINARY SKILL IN THE ART
`
`25. 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 industry experience may compensate for a deficit in one of the
`
`other aspects of the requirements stated above.
`
`26.
`
`I am a person of at least ordinary skill in the art, and was such a person as
`
`of the ’749 Patent’s earliest possible effective filing date of March 28, 2007.
`
` OVERVIEW OF CONCLUSIONS
`
`27. This Declaration explains the conclusions that I have formed based on
`
`my independent analysis. To summarize, based upon my knowledge, experience,
`
`and my review of the documents listed above, I believe that claims 1 and 3 of the
`
`’749 Patent are anticipated and/or obvious in light of Shelton II, Swayze, and
`
`Shelton I. The chart below provides citations to the paragraphs below where I
`
`discuss the substantive claim features.
`
`
`
`
`
`
`
`10
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`
`
`Claim Feature
`
`Paragraph Numbers
`
`U.S. Patent No. 7,490,749
`
`1[pre]: A surgical instrument,
`comprising:
`
`1[a]: a handle assembly;
`
`Shelton II, ¶90
`
`Swayze, ¶123
`
`Shelton I, ¶132
`
`Shelton II, ¶91
`
`Swayze, ¶124
`
`Shelton I, ¶133
`
`1[b]: an end effector for performing a
`surgical operation, said end effector
`operably coupled to said handle
`assembly and
`
`Shelton II, ¶¶92-94
`
`Swayze, ¶125
`
`Shelton I, ¶¶134-136
`
`1[b.i]: [the end effector] operably
`supporting a firing member that is
`movable from a retracted position to a
`fired position in response to a
`longitudinal firing motion applied
`thereto;
`
`Shelton II, ¶¶95-98
`
`Swayze, ¶126
`
`Shelton I, ¶¶137-139
`
`1[c]: a firing drive supported by said
`handle assembly and configured to
`selectively generate said longitudinal
`firing motion upon actuation of a
`firing trigger operably coupled to said
`handle assembly; and
`
`1[d]: 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
`
`Shelton II, ¶¶99-104
`
`Swayze, ¶127
`
`Shelton I, ¶¶140-151
`
`Shelton II, ¶¶105-112 (see also ¶¶57-69)
`
`Swayze, ¶128 (see also 70-79)
`
`Shelton I, ¶¶152-157
`
`
`
`11
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`
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`U.S. Patent No. 7,490,749
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`motion which is communicated to
`said firing member to cause said
`firing member to move from said
`fired position to said retracted
`position.
`
`3[a]: a closure drive supported by
`said handle assembly and configured
`to generate a closing motion and an
`opening motion; and
`
`Shelton II, ¶¶113-117
`
`Swayze, ¶129
`
`Shelton I, ¶¶158-159
`
`3[b]: an elongate shaft assembly
`coupling said end effector to said
`handle assembly and configured to
`transfer said opening and closing
`motions and said firing and retraction
`motions thereto.
`
`Shelton II, ¶¶118-122
`
`Swayze, ¶130
`
`Shelton I, ¶¶160-162
`
`
`
` OVERVIEW OF THE ’749 PATENT
`
`28. To understand the ’749 Patent’s retraction assembly and how it
`
`provides the claimed “sole retraction motion,” one must understand the operation
`
`of the disclosed embodiments. The ’749 Patent’s Figure 1 (annotated below)
`
`illustrates a surgical stapling and severing instrument 10 featuring a handle
`
`assembly 20 having a pistol grip 36 and supporting an end effector 12 controlled
`
`through user actuation of a closure trigger 26 and a firing trigger 34. ’749 Patent,
`
`5:34-6:35.
`
`
`
`12
`
`
`
`U.S. Patent No. 7,490,749
`
`
`
`29. End effector 12 features a pivoting anvil 14 and an elongate channel
`
`16 housing a staple cartridge 82. ’749 Patent, 7:42-8:18, Figure 2 (annotated
`
`below), 3-6. Staples 92 are “fired” from cartridge 82 by pushing an E-beam 80
`
`through elongate channel 16 in the distal direction from a retracted position (Figure
`
`5, below) to a fired position (Figure 6, below). Id.
`
`30. This firing motion causes E-beam 80 to push a wedge sled driver 88
`
`through staple cartridge 82, which sequentially actuates drivers 90 that forcibly
`
`
`
`
`
`13
`
`
`
`eject (or “fire”) staples 92 upward into the closed anvil 14. Id.
`
`U.S. Patent No. 7,490,749
`
`
`
`31. To move anvil 14 from an open position (Figure 2) to a closed
`
`position (Figure 5), the user pulls closure trigger 26 inward toward pistol grip 36 to
`
`operate a “longitudinally reciprocating” closure tube 24. ’749 Patent, 9:10-14; see
`
`also 5:60-62, Figures 1, 4, 8.
`
`
`
`14
`
`
`
`U.S. Patent No. 7,490,749
`
`
`
`32. As the user pulls closure trigger 26, the trigger’s upper portion 160
`
`pushes a closure yoke 162 in the distal direction (i.e., away from pistol grip 36).
`
`’749 Patent, 9:28-40, Figures 7-8. A closure link 164 is pivotally attached to upper
`
`portion 160 and closure yoke 162, such that rotational movement of upper portion
`
`160 is converted to longitudinal movement of closure yoke 162. Id.
`
`
`
`15
`
`
`
`U.S. Patent No. 7,490,749
`
`
`
`33. Closure yoke 162 then forces closure tube 24 to move longitudinally
`
`in the distal direction, moving pivot pins 54 of anvil 14 distally through kidney
`
`shaped openings 58 of elongate channel 16, which causes anvil 14 to rotate
`
`downward from the open position to the closed position. ’749 Patent, 7:2-23,
`
`Figure 4.
`
`34. Once released (by pressing a closure release button 38), a tension
`
`spring 246 draws closure trigger 26 through a recovery stroke to its starting
`
`position. ’749 Patent, 9:35-10:4, Figures 7-8. This causes the trigger’s upper
`
`portion 160 to pull closure yoke 162, and therefore closure tube 24, in the proximal
`
`direction (i.e., towards pistol grip 36), which moves pivot pins 54 proximally
`
`through kidney shaped openings 58 and rotates anvil 14 upward to the open
`
`
`
`16
`
`
`
`U.S. Patent No. 7,490,749
`
`position. ’749 Patent, 7:2-23, 9:28-35, Figures 4, 7-8.
`
`35. With anvil 14 closed to clamp the patient’s tissue, staples 92 are fired
`
`from staple cartridge 82 into anvil 14 by manual actuation of firing trigger 34.
`
`’749 Patent, 7:42-8:18, 10:4-12:7, Figures 1-6, 8, 10, 11. The user actuates firing
`
`trigger 34 by pulling it towards pistol grip 36. ’749 Patent, 6:8-35. Rotation of
`
`firing trigger 34 towards pistol grip 36 causes the upper portion 204 of firing
`
`trigger 34 to engage the links 196a-d of a linked rack 200 through a side pawl
`
`mechanism 210. ’749 Patent, 10:19-28; see also 11:4-8, 11:25-12:7, Figures 8, 10-
`
`11. More specifically, as the user pulls firing trigger 34, side pawl mechanism 210
`
`engages the ramped track 282 of an adjacent link 196a-d to longitudinally advance
`
`linked rack 200 in the firing (distal) direction. Id. When firing trigger 34 is pulled
`
`by the user through a full firing stroke, side pawl mechanism 210 disengages (or
`
`“kicks out”) from linked rack 200 during the spring-biased return stroke of firing
`
`trigger 34. Id.
`
`
`
`17
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`
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`U.S. Patent No. 7,490,749
`
`
`
`36. The distal end of linked rack 200’s front link 196a is connected to the
`
`proximal end of a firing rod 32 that communicates longitudinal movement from
`
`linked rack 200 to E-beam 80 through a series of components housed by a frame
`
`28 mounted within closure tube 24. ’749 Patent, 11:8-10. As the ’749 Patent
`
`explains, firing rod 32 engages a firing trough member 66, and firing trough
`
`member 66 is attached to a firing bar 76 having an E-beam 80 extending from its
`
`distal end. ’749 Patent, 7:24-42, Figure 4.
`
`
`
`18
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`
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`U.S. Patent No. 7,490,749
`
`
`
`37. The claimed “sole retraction motion” (Element 1[d]) that retracts E-
`
`beam 80 (via firing bar 32) from a fired position within end effector 12 to a
`
`retracted position is generated by the user manually depressing a retraction lever
`
`42. Depressing retraction lever 42 causes a locking pawl 516, which is biased by
`
`an L-shaped spring tab 522, to drivingly engage the teeth of a small ratchet gear
`
`231 projecting into a hub 506 of lever 42. ’749 Patent, 12:55-13:6, Figures 7-17;
`
`see also 12:9-56. This drives (counterclockwise1) a larger second gear 230
`
`connected to ratchet gear 231, which, in turn, drives (clockwise) a first gear 220
`
`
`1 Clockwise/counterclockwise directionality is with specific reference to Figure 12
`
`(annotated below).
`
`
`
`19
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`
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`U.S. Patent No. 7,490,749
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`meshed to a toothed surface 222 of linked rack 200. Id (Figures 16-17 are
`
`illustrative). The meshing engagement between first gear 220 and toothed surface
`
`222, causes linked rack 200, and therefore firing bar 32, to be drawn in the
`
`longitudinal (proximal) retraction direction. Id.
`
`
`
`38. Retracting E-Beam 80 from a fired position to a retracted position
`
`may require multiple actuations of retraction lever 42. Id. Accordingly, a recovery
`
`spring 525 is provided to urge the depressed retraction lever 42 back upwards
`
`towards its starting position, with pawl 516 disengaging from the teeth of ratchet
`
`gear 231 during this motion, permitting the retraction lever 42 to be actuated again.
`
`Id.
`
`
`
`20
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`
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`U.S. Patent No. 7,490,749
`
` INTERPRETATION OF THE ’749 PATENT CLAIMS AT ISSUE
`
`39.
`
`I have been informed by Counsel for Intuitive that claim terms failing
`
`to recite sufficiently definite structure or else reciting function without sufficient
`
`structure for performing that function2 are interpreted under a specific framework
`
`that requires an analysis of the corresponding structure described in the
`
`specification that performs the claimed function. I find that four terms of the ’749
`
`Patent’s claims 1 and 3 should be interpreted in this way.
`
`Claim 1—Firing Member
`
`40. From the perspective of an ordinarily skilled person in the art, the
`
`word “member” has no clear meaning as the name for a specific type of structure.
`
`I note that the McGraw-Hill Dictionary of Scientific and Technical Terms (6th
`
`Edition, 2003) defines the term “member” as “[a] structural unit” or “an individual
`
`object that belongs to a set.” IS1012, 7. This word and its generic definition could
`
`be used to describe almost any component of a mechanical device. The preceding
`
`modifier “firing” is a purely functional term and does not further specify the word
`
`“member” from a structural perspective. The remainder of claim 1 simply
`
`
`2 I have been informed that this legal standard is met when claim terms, viewed
`
`from the perspective of a person having ordinary skill in the art (A) lack meaning
`
`as the name for structure; and (B) are not defined in terms of structure by the
`
`remaining portions of the claim.
`
`
`
`21
`
`
`
`U.S. Patent No. 7,490,749
`
`identifies the function of this “member”—moving between a retracted and fired
`
`position—and is therefore also of little value in terms of clarifying its structure.
`
`41. The claimed functions performed by the “member” are “firing” and
`
`“mov[ing] from a retracted position to a fired position in response to a longitudinal
`
`firing motion applied thereto.” As to these functions, the ’749 Patent explains that
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`E-beam 80 is moved longitudinally from a retracted position to a fired position by
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`a firing rod 32 coupled to a linked rack 200 driven by manual actuation of a firing
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`trigger 34. ’749 Patent, 7:42-8:18, 10:4-12:7, Figures 1-6, 8, 10, 11 . As E-beam
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`80 performs the claimed “mov[ing]” function, it also performs the “firing” function
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`by pushing a wedge sled driver 88 that causes drivers 90 in a staple cartridge 82 to
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`eject staples 92 and form them against clamped anvil 14. ’749 Patent, 7:42-8:18.
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`The corresponding “firing member” structure therefore includes E-beam 80.
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`42. Notably, the ’749 Patent’s E-beam 80 is a three-pin design featuring
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`an upper pin 110, a middle pin 106, and a lower pin 108. ’749 Patent, 7:59-8:18,
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`Figures 2 (below), 5-6. Middle pin 106 drives the staple cartridge 82’s wedge sled
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`driver 883 to effectuate firing of staples 92. Id. Bottom pin 108 engages and slides
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`3 Wedge sled driver 88 is pushed in the distal (firing) direction by E-beam 80, but
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`it does not move in the proximal (retraction) direction with E-beam 80. Thus,
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`wedge sled driver 88 is merely part of staple cartridge 82, not the retractable firing
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`member (i.e., E-beam 80).
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`22
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`U.S. Patent No. 7,490,749
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`along a bottom surface of end effector channel 16. Id. And top pin translates
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`through a slot 114 of anvil 14, so as to maintain spacing between anvil 14 from end
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`effector channel 16 during the stapling/severing process. Id.
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`
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`Claim 1—Retraction Assembly
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`43. From the perspective of an ordinarily skilled person in the art, the
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`word “assembly” has no clear meaning as the name for a specific type of structure.
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`I note that the McGraw-Hill Dictionary of Scientific and Technical Terms (6th
`
`Edition, 2003) defines the term “assembly” as “[a] unit containing the component
`
`parts of a mechanism, machine, or similar device.” IS1012, 3. This word and its
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`generic definition could be used to describe almost any collection of components
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`of a mechanical device. The preceding modifier “retraction” is a purely functional
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`term and does not further specify the word “assembly” from a structural
`
`perspective. According to claim 1, the “assembly” is “supported by said handle
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`assembly and interfac[es] with said “firing drive.” But, while these high-level
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`
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`23
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`U.S. Patent No. 7,490,749
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`statements establish a relationship between the “assembly” and other claim
`
`elements, they do not provide much (if any) information about the structure of the
`
`“assembly” itself.
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`44. The claimed functions performed by the “assembly” are “retract[ing]”
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`and “interfacing” with said firing drive such that manual actuation of said
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`retraction assembly causes said firing drive to generate a sole retraction motion
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`which is communicated to said firing member to cause said firing member to move
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`from said fired position to said retracted position.” As to these retraction
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`functions, the ’749 Patent explains that manually actuating retraction lever 42
`
`drives a gear train via a locking pawl 516 biased by a spring tab 522 residing in a
`
`hub 506 of retraction lever 42. ’749 Patent, 12:9-13:6, Figures 7-17. The gear
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`train includes ratchet gear 231, second gear 230, and first gear 220. Id. First gear
`
`220 meshes with a toothed surface 222 of linked rack 200 to progressively urge
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`linked rack 200—and therefore firing rod 32 and E-beam 80, which are both
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`drivingly coupled to linked rack 200—in the longitudinal (proximal) retraction
`
`direction. Id.
`
`45. The corresponding “retraction assembly” structure (identified above)
`
`therefore includes a first gear 220 meshed to a toothed surface 222 of linked rack
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`200, a second gear 230 meshed to first gear 220 that includes a ratchet gear 231, a
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`spring-biased, multi-stroke retraction lever 42 including a hub 506 into which
`
`
`
`24
`
`
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`ratchet gear 231 extends, and a locking pawl 516 mounted within hub 516 and
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`biased by an L-shaped spring tab 522 against ratchet gear 231.
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`U.S. Patent No. 7,490,749
`
`
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`Claim 1—Firing Drive
`
`46. From the perspective of an ordinarily skilled person in the art, the
`
`word “drive” has no clear meaning as the name for a specific type of structure. I
`
`note that the McGraw-Hill Dictionary of Scientific and Technical Terms (6th
`
`Edition, 2003) defines the term “drive” in noun form as “[t]he means by which a
`
`machine is given motion or power . . ., or by which power is transferred from one
`
`part of a machine to another.” IS1012, 5. This word and its generic definition
`
`could be used to describe almost any component or collection of components that
`
`function in a mechanical device to transfer power. So, while the term “drive” has a
`
`functional meaning to the ordinarily skilled person (i.e., a drive must provide or
`
`
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`25
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`U.S. Patent No. 7,490,749
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`transfer power), it does not have a defined structural meaning (i.e., a drive could
`
`include any means of providing/transferring power). As I noted, the preceding
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`modifier “firing” is a purely functional term, and therefore does not further specify
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`the equally functional word “drive” from a structural perspective. According to
`
`claim 1, the “drive” is “supported by said handle assembly” and “interfac[es]” with
`
`the retraction assembly. But, as with the term “retraction assembly,” these high-
`
`level statements merely establish a relationship between the “drive” and certain
`
`other claim elements; they do not provide much (if any) information about the
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`structure of the “drive” itself.
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`47. The claimed functions performed by the “drive” are “firing” and
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`“selectively generat[ing] said longitudinal firing motion upon actuation of a firing
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`trigger operably coupled to said handle assembly.” As to these functions, the ’749
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`Patent explains that manually actuating firing trigger 34 causes an upper portion
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`204 of firing trigger 34 to engage the links 196a-d of a linked rack 200 through a
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`kick-out side pawl mechanism 210 that interfaces with a ramped track 282
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`presented on one side of each link 196a-d. ’749 Patent, 6:8-35, 10:19-28; see also,
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`11:4-10, 11:25-12:7, Figures 8, 10-11. The distal end of the front link 196a is
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`connected to the proximal end of a firing rod 32 that communicates longitudinal
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`movement from linked rack 200 to E-beam 80 through a series of components
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`26
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`U.S. Patent No. 7,490,749
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`housed by a frame 28 mounted within closure tube 24. ’749 Patent, 11:8-10; see
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`also 7:24-42, Figure 4.
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`48. The corresponding “firing drive” structure (identified above) therefore
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`includes a linked rack 200 including links 196a-d having a ramped track 282, a
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`firing rod 32 attached to linked rack 200, and a side pawl mechanism 210 coupled
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`to a firing trigger 34.
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`
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`Closure Drive—Claim 3
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`49. My prior discussion of the term “drive” (¶45, above) applies equally
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`here. Again, this term has a functional meaning to the ordinarily skilled person,
`
`but it does not have a defined structural meaning. The preceding modifier
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`“closure” is a purely functional term, and therefore does not further specify the
`
`
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`27
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`U.S. Patent No. 7,490,749
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`equally functional word “drive” from a structural perspective. According to claim
`
`3, this “drive” is “supported by said handle assembly.” But these high-level
`
`statements merely establish a relationship between the “drive” and certain other
`
`claim elements; they do not provide much (if any) information about the structure
`
`of the “drive” itself.
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`50. The claimed functions performed by the “drive” are “clos[ing]” and
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`“generat[ing] a closing motion and an opening motion.” As to these functions, the
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`’749 Patent explains that manually actuating closure trigger 26 causes its upper
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`portion 160 to push or pull a closure yoke 162 via a pivotally mounted closure link
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`164. ’749 Patent, 9:10-14, 9:28-40, Figures 7-8. Movement of closure yoke 162
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`causes a closure tube 24 to move longitudinally in the distal or proximal direction,
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`which closes or opens anvil 14. ’749 Patent, 5:60-62, 7:2-23, 9:10-14, 9:28-40,
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`Figures 1, 4, 7-8.
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`51. The corresponding “closure drive” structure (identified above)
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`therefore includes a closure trigger 26 having an upper portion 160 coupled to a
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`closure yoke 162 through a closure link 164 (referred to collectively as closure
`
`drive 23).
`
`
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`28
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`U.S. Patent No. 7,490,749
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`52. Beyond the four terms above, I see no reason that one of ordinary skill
`
`in the art would understand the broadest reasonable interpretation of the terms of
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`the challenged claims of the ’749 Patent to require clarification beyond the plain
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`
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`meaning of those terms.
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` OVERVIEW OF THE ASSERTED PRIOR ART
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`
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`Shelton II
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`53.
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`In my opinion, a person of ordinary skill would find the disclosures of
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`Shelton II and the ’749 Patent very similar. For example, the ’749 Patent and
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`Shelton II each provide the arrangement I previously described—a surgical
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`stapling and severing instrument including a pistol-grip handle assembly
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`supporting an end effector at a distal end of an elongate shaft assembly, in addition
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`
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`29
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`
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`U.S. Patent No. 7,490,749
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`to respective closure and firing drives for operating the end effector by manually
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`actuating corresponding closure and firing triggers. ’749 Patent, 5:3
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