IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Christopher J. Schall, et al.
`In re Patent of:
`7,490,749 Attorney Docket No.: 11030-0052IP1
`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
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT
`NO. 7,490,749 PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`TABLE OF CONTENTS
`
`I.
`
`MANDATORY NOTICES—37 C.F.R § 42.8 ................................................ 1
`A. Real Party-In-Interest—37 C.F.R. § 42.8(b)(1) ........................................ 1
`B. Related Matters—37 C.F.R. § 42.8(b)(2) ................................................. 1
`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ..................... 2
`D. Service Information .................................................................................. 2
`
`II.
`
`PAYMENT OF FEES—37 C.F.R. § 42.103 ................................................... 2
`
`III. REQUIREMENTS FOR IPR—37 C.F.R. § 42.104 ........................................ 3
`A. Grounds for Standing—37 C.F.R. § 42.104(a) ......................................... 3
`B. Challenge and Relief Requested—37 C.F.R. § 42.104(b) ....................... 3
`
`IV. OVERVIEW OF THE ’749 PATENT ............................................................ 4
`
`V.
`
`PROSECUTION OF THE ’749 PATENT ...................................................... 5
`
`VI. RELATION TO EX PARTE PROSECUTION ............................................... 5
`
`VII. THE ’749 PATENT’S SURGICAL INSTRUMENT ..................................... 8
`
`VIII. CLAIM CONSTRUCTION .......................................................................... 15
`A. Firing Member ........................................................................................ 16
`B. Retraction Assembly ............................................................................... 18
`C. Firing Drive ............................................................................................. 20
`D. Closure Drive .......................................................................................... 22
`
`IX. LEVEL OF ORDINARY SKILL .................................................................. 23
`
`X.
`
`THE CHALLENGED CLAIMS ARE UNPATENTABLE .......................... 24
`A. [GROUND 1]—Shelton II Anticipates and/or Renders Obvious the
`Challenged Claims Under Both 112(6) and Non-112(6) Interpretations ...
`
` ....................................................................................................... 24
`B. [GROUND 2]—Swayze Anticipates and/or Renders the Challenged
`Claims Obvious Under Both 112(6) and Non-112(6) Interpretations .... 50
`C. [GROUND 3]—Shelton I Anticipates the Challenged Claims Under a
`Non-112(6) Construction ........................................................................ 57
`
`XII. CONCLUSION .............................................................................................. 86
`
`
`
`
`
`
`i
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`EXHIBITS
`
`IS1001
`
`U.S. Patent No. 7,490,749 to Schall, et al. (“’749 Patent”)
`
`IS1002
`
`Excerpts from the Prosecution History of the ’749 Patent (“the
`Prosecution History”)1
`
`IS1003
`
`Declaration of Dr. Knodel, including Curriculum Vitae
`
`IS1004
`
`US Patent Publication No. 2006/0175375 (“Shelton II”)
`
`IS1005
`
`US Patent Publication No. 2005/0178813 (“Swayze”)
`
`IS1006
`
`US Patent No. 8,322,455 (“Shelton I”)
`
`IS1007
`
`IS1008
`
`IS1009
`
`Complaint for Patent Infringement, Ethicon LLC, et al. v.
`Intuitive Surgical, Inc., et al., Case No. 1:18-cv-01325 (D. Del.
`Aug. 27, 2018)
`
`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)
`
`
`1 Copies of foreign patent references removed.
`
`ii
`
`

`

`Intuitive Surgical, Inc. (“Petitioner”) petitions for Inter Partes Review
`
`(“IPR”) of claims 1 and 3 (“the Challenged Claims”) of U.S. Patent No. 7,490,749
`
`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`(“the ’749 Patent”).
`
`I. MANDATORY NOTICES—37 C.F.R § 42.8
`
`A. Real Party-In-Interest—37 C.F.R. § 42.8(b)(1)
`
`Intuitive Surgical, Inc. is the real party-in-interest.
`
`B. Related Matters—37 C.F.R. § 42.8(b)(2)
`
`Petitioner is not aware of any disclaimers, reexamination certificates, or
`
`petitions for IPR of the ’749 Patent. The ’749 Patent is the subject of Civil Action
`
`No. 1:18-cv-01325, filed on August 27, 2018 in the District Court for the District
`
`of Delaware. And the following IPRs involve patents that belong to Patent Owner
`
`and have been asserted against Petitioner in the District of Delaware: Intuitive
`
`Surgical, Inc. v. Ethicon LLC, Case Nos. IPR2018-00933, -934, -935, -936, -938, -
`
`1247, -1703, -1248, and -1254.
`
`
`
`
`
`1
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`Petitioner provides the following designation of counsel.
`
`LEAD COUNSEL
`Steven R. Katz, Reg. No. 43,706
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 617-542-5070 / Fax 877-769-7945
`
`BACK-UP COUNSEL
`Joshua A. Griswold, Reg. No. 46,310
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 214-292-4034
`
`Kenneth W. Darby, Jr., Reg. No. 65,068
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 512-226-8126
`
`John C. Phillips, Reg. No. 35,322
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 858-678-5070
`
`Ryan P. O’Connor, Reg. No. 60,254
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 858-678-5070
`
`
`
`D.
`
`Service Information
`
`Please address all correspondence and service to the address listed above.
`
`Petitioner consents to electronic service by email at IPR11030-0052IP1@fr.com
`
`(referencing No. 11030-0052IP1 and cc’ing PTABInbound@fr.com, katz@fr.com,
`
`griswold@fr.com, kdarby@fr.com, phillips@fr.com, and oconnor@fr.com).
`
`II.
`
`PAYMENT OF FEES—37 C.F.R. § 42.103
`
`Petitioner authorizes the Office to charge Deposit Account No. 06-1050 for
`
`the petition fee set in 37 C.F.R. § 42.15(a) and for any other required fees.
`
`2
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`III. REQUIREMENTS FOR IPR—37 C.F.R. § 42.104
`
`A. Grounds for Standing—37 C.F.R. § 42.104(a)
`
`Petitioner certifies that the ’749 Patent is available for IPR, and Petitioner is
`
`not barred or estopped from requesting IPR.
`
`B. Challenge and Relief Requested—37 C.F.R. § 42.104(b)
`
`Petitioner requests IPR of claims 1 and 3 of the ’749 Patent on the grounds
`
`listed below. A declaration from Dr. Knodel (IS1003) is included in support.
`
`Ground
`
`Claims
`
`Basis
`
`Ground 1
`
`Ground 2
`
`Ground 3
`
`1, 3
`
`1, 3
`
`1, 3
`
`Anticipated and/or Obvious by Shelton II (IS1004)
`
`Anticipated and/or Obvious by Swayze (IS1005)
`
`Anticipated by Shelton I (IS1006)
`
`Shelton II (US 2006/0175375) was published August 10, 2006. Shelton II
`
`lists entirely different inventors than the ’749 Patent, and was published before the
`
`’749 Patent’s earliest effective filing date (March 28, 2007). Shelton II, therefore,
`
`is prior art under pre-AIA 35 U.S.C. §§ 102(a) and 102(e).
`
`Swayze (US 2005/0178813) was published August 18, 2005, more than a
`
`year before the ’749 Patent’s earliest effective filing date. Swayze, therefore, is
`
`prior art under pre-AIA 35 U.S.C. § 102(b).
`
`Shelton I (US 8,322,455) was filed June 27, 2006 and issued December 4,
`
`2012. Shelton I lists entirely different inventors than the ’749 Patent, and Shelton
`
`I’s filing date antedates the ’749 Patent’s earliest effective filing date. Shelton I,
`
`3
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`therefore, is prior art under pre-AIA 35 U.S.C. § 102(e).
`
`IV. OVERVIEW OF THE ’749 PATENT
`
`The ’749 Patent describes endoscopic surgical instruments—surgical
`
`staplers “capable of applying lines of staples to tissue while cutting the tissue
`
`between those staple lines,” in particular. ’749 Patent, 18-25. And the ’749 Patent
`
`focused on such an instrument “with a manually actuatable retraction mechanism”
`
`and “[without] an additional retraction means.” ’749 Patent, 2:66-3:4. The ’749
`
`Patent removed the commonly used retraction springs that tend to “increase[] the
`
`amount of firing forces that must be generated to overcome the spring force and
`
`fire the end effector components.” ’749 Patent, 2:34-65. As shown below,
`
`however, a manual retraction mechanism lacking a retraction spring was already
`
`known.
`
`
`
`
`
`4
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`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`V.
`
`PROSECUTION OF THE ’749 PATENT
`
`Prosecution leading to the ’749 Patent was short. A first Office Action
`
`raising a restriction requirement was mailed on June 16, 2008 (IS1002, 105-110),
`
`and a Notice of Allowance issued less than four months later on October 1, 2008
`
`(IS1002, 13-18). While the ’749 Patent lists hundreds of applicant-submitted prior
`
`art references, the examiner made no prior art rejections. See IS1002, 52-56, 105-
`
`110.
`
`The examiner’s articulated rationale for allowing the ’749 Patent does not
`
`support the allowed claims. For example, the examiner’s statement emphasizes
`
`elements that are not the independent claims (e.g., “retraction member,” “firing
`
`mechanism,” “driving mechanism”). IS1002, 55. The examiner’s statement also
`
`refers to unidentified “closest prior art” that describes “retraction mechanisms
`
`which manually move the firing mechanisms in both directions proximally and
`
`distally.” Id. But the examiner did not explain how such a teaching is
`
`distinguishable from the ’749 Patent’s claims. And, more importantly, the
`
`examiner’s finding that this teaching is “the closest prior art” suggests other more
`
`pertinent references—such as Shelton II, Swayze, and Shelton I that have a
`
`different retraction mechansim—were overlooked.
`
`VI. RELATION TO EX PARTE PROSECUTION
`
`While Shelton II, Swayze, and Shelton I were among hundreds of references
`
`5
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`before the examiner, the prosecution record reflects the examiner did not fully
`
`appreciate the teachings of these references. For example, in the thousands of
`
`pages of applicant-submitted prior art2, the examiner missed Shelton II’s express
`
`statement that its manual retraction assembly “could be utilized without the
`
`assistance of a retraction spring,” which would yield the ’749 Patent’s “sole
`
`retraction motion” feature identified in the examiner’s reasons for allowance. See
`
`Shelton II, ¶0154; IS1002, 55; analysis infra at Ground 1, Element 1[d]. The
`
`examiner also lacked the benefit of Patent Owner’s broad infringement allegations
`
`against Petitioner, in which Patent Owner contends the “sole retraction motion”
`
`feature is met when a primary retraction mechanism malfunctions, leaving only a
`
`backup manual retraction mechanism. See IS1007, 14 (alleging infringement
`
`against a “Manual Release Knob” used when there is “[a] lack of power or a non-
`
`recoverable fault”). Under these allegations, the “sole retraction motion” is
`
`likewise met by the disclosures in Shelton II and Swayze of manual retraction
`
`assemblies that serve as a redundancy to an automatic retraction spring that “may
`
`become disconnected.” Shelton II, ¶0144, Swayze, ¶0155; see also analysis infra
`
`
`2 IS1002, 35-40, 82-90, 115-116, 121-123, 134-135.
`
`6
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`at Ground 1, Element 1[d]3.
`
`It is not surprising that the full teachings of Shelton I, Swayze, and Shelton
`
`II were overlooked. Not only was the examiner burdened by hundreds of
`
`references submitted by the applicant, but each of the invalidating references used
`
`here are voluminous. For example, Shelton II is 61-pages within which the
`
`examiner could have easily overlooked the critical teaching that the manual
`
`retraction assembly “could be utilized without assistance of a retraction spring”
`
`(¶0154).
`
`The examiner also could not have known how Patent Owner would later
`
`characterize its claims in fashioning an overly broad infringement theory that
`
`requires a malfunctioning primary mechanism to be ignored when assessing
`
`whether the backup manual mechanism causes the “sole” retraction motion.
`
`IS1007, 14-15. Critically, this teaching is disclosed by both Shelton II and Swayze
`
`(also a 61-page reference), which state that the automatic retraction spring “may
`
`become disconnected,” thus requiring use of the manual backup retraction
`
`mechanism. Shelton II, ¶0144, Swayze, ¶0155. For at least these reasons, despite
`
`
`3 These arguments are based solely on Patent Owner’s infringement allegations and
`
`their implicit claim constructions, with which Petitioner does not concede
`
`subjective agreement.
`
`7
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`the wealth of references listed on the face of the patent, the issued claims of the
`
`’749 Patent have yet to be fully tested against the prior art.
`
`Accordingly, there is no basis for a determination under 35 U.S.C. § 325(d)
`
`that substantially similar prior art and/or arguments have already been presented to
`
`the Office. Cf. Becton, Dickinson and Company v. B. Braun Melsungen AG,
`
`IPR2017-01586, Paper 8 at 17-28 (PTAB Dec. 15, 2017 (informative)).
`
`VII. THE ’749 PATENT’S SURGICAL INSTRUMENT
`
`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. See generally ’749 Patent, 5:34-6:35.
`
`
`
`
`
`
`
`8
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`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`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.
`
`
`
`
`
`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 eject (or
`
`“fire”) staples 92 upward
`
`into the closed anvil 14. Id.
`
`9
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`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`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 id.,
`
`5:60-62, Figures 1, 4, 8.
`
`
`
`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.
`
`10
`
`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`
`
`Closure yoke 162 then forces closure tube 24 to move longitudinally in the distal
`
`direction (see id.), 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.
`
`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), moving pivot pins 54 proximally through kidney shaped
`
`openings 58 and rotates anvil 14 upward to the open position. ’749 Patent, 7:2-23,
`
`9:28-35, Figures 4, 7-8.
`
`11
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`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`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. See
`
`generally ’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 id., 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
`
`
`
`12
`
`

`

`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
`
`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`trigger 34. Id.
`
`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.
`
`
`
`
`
`13
`
`
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`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`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.
`
`IS1003, ¶37. 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 id., 12:9-56.
`
`This drives (counterclockwise4) a larger second gear 230 connected to ratchet gear
`
`231, which, in turn, drives (clockwise) a first gear 220 meshed to a toothed surface
`
`
`
`
`4 Clockwise/counterclockwise directionality is with specific reference to Figure 12.
`
`14
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`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`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.
`
`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.
`
`VIII. CLAIM CONSTRUCTION
`
`Terms of the Challenged Claims should generally be given their plain and
`
`ordinary meaning consistent with the ’749 Patent’s specification, which we have
`
`done here, unless otherwise noted. For example, as discussed below, four terms at
`
`issue in this proceeding require a 112(6) construction.
`
`
`
`
`
`15
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`

`

`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`A.
`
`Firing Member
`
`The term “member” is a nonce term and the purely functional nature of the
`
`modifier “firing” would not have connoted structure to a POSITA. IS1003, ¶40
`
`(explaining that the term “member” and its generic dictionary definition5 has no
`
`clear meaning to a POSITA for a specific type of structure). The surrounding
`
`claim language also fails to suggest structure. Id. As such, the negative
`
`presumption against 112(6) treatment under Williamson v. Citrix Online, LLC, 792
`
`F.3d 1339 (Fed. Cir. 2015) is overcome.
`
`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,” which require no further construction. As to these
`
`functions, the ’749 Patent explains (see Section VII, supra) that E-beam 80 is
`
`moved longitudinally from a retracted position to a fired position by a firing rod 32
`
`coupled to a linked rack 200 driven by manual actuation of a firing trigger 34. See
`
`generally ’749 Patent, 7:42-8:18, 10:4-12:7, Figures 1-6, 8, 10, 11. As E-beam 80
`
`performs the claimed “mov[ing]” function, it also performs the “firing” function by
`
`pushing a wedge sled driver 88 that causes drivers 90 in a staple cartridge 82 to
`
`
`5 The term “member” is defined as “[a] structural unit” or “an individual object that
`
`belongs to a set.” IS1012, 7.
`
`16
`
`

`

`eject staples 92 and form them against clamped anvil 14. ’749 Patent, 7:42-8:18.
`
`The corresponding “firing member” structure therefore includes E-beam 80.
`
`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
`
`IS1003, ¶¶41-42.
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`Notably, the ’749 Patent’s E-beam 80 is a three-pin design featuring an
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`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 88 to effectuate firing of staples 92. Id. Bottom pin 108 engages and slides
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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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`17
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`B. Retraction Assembly
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`The term “assembly” is a nonce term and the purely functional nature of the
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`modifier “retraction” would not have connoted structure to a POSITA. IS1003,
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`¶43 (explaining that the term “assembly” and its generic dictionary definition6 has
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`no clear meaning to a POSITA for a specific type of structure). The surrounding
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`claim language also fails to suggest structure. Id. As such, the negative
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`presumption against 112(6) treatment under Williamson is overcome.
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`The claimed functions performed by the “assembly” are “retract[ing]” and
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`“interfacing with said firing drive such that manual actuation of said retraction
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`assembly causes said firing drive to generate a sole retraction motion which is
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`communicated to said firing member to cause said firing member to move from
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`said fired position to said retracted position,” which require no further
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`construction. As to these retraction functions, the ’749 Patent explains (see
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`Section VII, supra) that manually actuating retraction lever 42 drives a gear train
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`via a locking pawl 516 biased by a spring tab 522 residing in a hub 506 of
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`retraction lever 42. See generally ’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
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`6 The term “assembly” is defined as “[a] unit containing the component parts of a
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`mechanism, machine, or similar device.” IS1012, 3.
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`18
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`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
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`direction. Id.
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`The corresponding “retraction assembly” structure (identified above)
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`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
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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. IS1003, ¶¶44-45.
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`19
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`C.
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`Firing Drive
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`The term “drive” is a nonce term and the purely functional nature of the
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`modifier “firing” would not have connoted structure to a POSITA. IS1003, ¶46
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`(explaining that the term “drive” and its generic dictionary definition7 has no clear
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`meaning to a POSITA for a specific type of structure). The surrounding claim
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`language also fails to suggest structure. Id. As such, the negative presumption
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`against 112(6) treatment under Williamson is overcome.
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`The claimed functions performed by the “drive” are “firing” and “selectively
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`generat[ing] said longitudinal firing motion upon actuation of a firing trigger
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`operably coupled to said handle assembly,” which require no further construction.
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`As to these functions, the ’749 Patent explains (see Section VII, supra) that
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`manually actuating firing trigger 34 causes an upper portion 204 of firing trigger
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`34 to engage the links 196a-d of a linked rack 200 through a kick-out side pawl
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`mechanism 210 that interfaces with a ramped track 282 presented on one side of
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`each link 196a-d. ’749 Patent, 6:8-35, 10:19-28; see also id., 11:4-10, 11:25-12:7,
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`Figures 8, 10-11. The distal end of the front link 196a is connected to the proximal
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`7 The term “drive” in noun form is defined as “[t]he means by which a machine is
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`given motion or power . . ., or by which power is transferred from one part of a
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`machine to another.” IS1012, p. 5.
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`20
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`end of a firing rod 32 that communicates longitudinal movement from linked rack
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`200 to E-beam 80 through a series of components housed by a frame 28 mounted
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`within closure tube 24. ’749 Patent, 11:8-10; see also 7:24-42, Figure 4.
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`The corresponding “firing drive” structure (identified above) therefore includes a
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`linked rack 200 including links 196a-d having a ramped track 282, a firing rod 32
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`attached to linked rack 200, and a side pawl mechanism 210 coupled to a firing
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`trigger 34. IS1003, ¶¶47-48.
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`21
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`D. Closure Drive
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`The term “drive” is a nonce term and the purely functional nature of the
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`modifier “closure” would not have connoted structure to a POSITA. IS1003, ¶49
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`(explaining that the term “drive” and its generic dictionary definition has no clear
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`meaning to a POSITA for a specific type of structure). The surrounding claim
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`language also fails to suggest structure. Id. As such, the negative presumption
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`against 112(6) treatment under Williamson is overcome.
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`The claimed functions performed by the “drive” are “clos[ing]” and
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`“generat[ing] a closing motion and an opening motion,” which require no further
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`construction. As to these functions, the ’749 Patent explains (see Section VII,
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`supra) that manually actuating closure trigger 26 causes its upper portion 160 to
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`push or pull a closure yoke 162 via a pivotally mounted closure link 164. ’749
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`Patent, 9:10-14, 9:28-40, Figures 7-8. Movement of closure yoke 162 causes a
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`closure tube 24 to move longitudinally in the distal or proximal direction, which
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`closes or opens anvil 14. ’749 Patent, 5:60-62, 7:2-23, 9:10-14, 9:28-40, Figures 1,
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`4, 7-8.
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`22
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`The corresponding “closure drive” structure (identified above) therefore includes a
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`closure trigger 26 having an upper portion 160 coupled to a closure yoke 162
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`through a closure link 164 (referred to collectively as closure drive 23). IS1003,
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`
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`¶¶50-51.
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`IX.
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`LEVEL OF ORDINARY SKILL
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`A person of ordinary skill in the art at the time of the claimed invention
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`(“POSITA”) would have had the equivalent of a Bachelor’s degree or higher in
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`mechanical engineering, or a related field directed towards medical mechanical
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`systems, and at least 3 years working experience in research and development for
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`surgical instruments. IS1003, ¶25.
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`23
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`X.
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`THE CHALLENGED CLAIMS ARE UNPATENTABLE
`
`A.
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`[GROUND 1]—Shelton II Anticipates and/or Renders Obvious
`the Challenged Claims Under Both 112(6) and Non-112(6)
`Interpretations
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`Overview of Shelton II
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`The disclosures of Shelton II and the ’749 Patent are very similar. See
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`generally IS1003, ¶¶53-54. The similarities will be discussed in detail in the
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`element-by-element analysis of the claims that follows this overview. Starting
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`with the ’749 Patent, as discussed (see Section VII, supra), its surgical stapling and
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`severing instrument features a pistol-grip handle assembly supporting an end
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`effector at a distal end of an elongate shaft assembly, in addition to respective
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`closure and firing drives for operating the end effector by manually actuating
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`corresponding closure and firing triggers. See generally ’749 Patent, 5:34-6:35,
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`9:27-13:25. Shelton II describes the same arrangement, as demonstrated by the
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`following side-by-side comparison of figures. See generally Shelton II, ¶¶0125-
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`0132, 0135-0141.
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`*
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`*
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`24
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`*
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`As discussed (see Section VII, supra), the ’749 Patent further describes a
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`manually-actuated retraction assembly that interfaces with the firing drive to
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`retract a firing member from its fired position within the end effector to a retracted
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`25
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`position. ’749 Patent, 12:9-13:6. Shelton II describes such a retraction assembly
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`as well, as demonstrated by the following comparison. Shelton II, ¶¶0141-0144.
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`
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`Shelton II also describes an automatic retraction spring and an anti-backup
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`mechanism that prevents premature activation of the retraction spring. Shelton II,
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`¶¶0131-0134; IS1003, ¶55. In the preferred embodiments of Shelton II’s surgical
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`instrument, the automatic retraction spring serves as the primary manner of
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`retracting the firing member, with the manually-actuated retraction assembly
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`serving as a redundancy for when the retraction spring malfunctions. Shelton II,
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`¶0144.
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`Thus, the preferred embodiment of Shelton II differs from the ’749 Patent’s
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`claimed embodiment in that the ’749 Patent’s claimed embodiment eliminates the
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`retraction spring, and recites that the retraction assembly “causes said firing drive
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`to generate a sole retraction motion” (thus, without any springs or force
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`generators). ’749 Patent, 16:14-28; IS1003, ¶56. However, manual retraction
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`26
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`Attorney Docket No. 11030-0052IP1
`IPR of U.S. Patent No. 7,490,749
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`without the need for a spring was not new, and was, in fact, already disclosed by
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`Shelton II. Shelton II’s manual retraction assembly causes its firing drive to
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`generate a retraction motion “without the assista