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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`__________________
`
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`Case IPR2019-00880
`Patent 7,490,749
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`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
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`PUBLIC VERSION
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`Proceeding No. IPR2019-00880
`Attorney Docket No. 11030-0052IP1
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
`CLAIM CONSTRUCTION ............................................................................ 1
` ARGUMENT ................................................................................................... 1
`A. The Challenged Claims Are Anticipated (Grounds 1-3) .......................... 1
`1. Ground 1: Shelton II Anticipates Because a POSITA Would Have
`Immediately Envisioned Removal of the Retraction Spring .......... 1
`2. Grounds 1-2: Shelton II and Swayze Each Anticipate When the
`Retraction Spring is Disconnected .................................................. 8
`3. Ground 3: Shelton I Anticipates Under Ethicon’s Non-112(6)
`Constructions ................................................................................. 12
`B. The Challenged Claims Are Obvious (Grounds 1-2) ............................. 12
`1.
`The Petition Provides Ample Motivation to Remove the
`Retraction Spring of Shelton II and Swayze ................................. 12
`Removing the Retraction Spring Leaves the Fundamental
`Principles of Operation Unchanged .............................................. 17
`Conventional Wisdom Supports Obviousness .............................. 18
`3.
`Ethicon Conflates Obviousness and Bodily Incorporation ........... 18
`4.
`C. Ethicon Cannot Swear Behind The Prior Art ......................................... 20
` ............ 20
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` ......... 24
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` CONCLUSION .............................................................................................. 25
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`2.
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`EXHIBITS
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`U.S. Patent No. 7,490,749 to Schall, et al. (“’749 Patent”)
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`Excerpts from the Prosecution History of the ’749 Patent (“the
`Prosecution History”)1
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`Declaration of Dr. Knodel, including Curriculum Vitae
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`US Patent Publication No. 2006/0175375 (“Shelton II”)
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`US Patent Publication No. 2005/0178813 (“Swayze”)
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`US Patent No. 8,322,455 (“Shelton I”)
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`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)
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`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)
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`Electronic Comparison of Written Description of Swayze (US
`2005/0178813; Original) to Shelton II (US 2006/0175375;
`Underline/Strikethrough)
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`U.S. Patent No. 5,941,442
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`U.S. Patent No. 5,865,361
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`Excerpts from McGraw-Hill Dictionary of Scientific and
`Technical Terms (6th Edition, 2003)
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`IS1001
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`IS1002
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`IS1003
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`IS1004
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`IS1005
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`IS1006
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`IS1007
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`IS1008
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`IS1009
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`IS1010
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`IS1011
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`IS1012
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`1 Copies of foreign patent references removed.
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`ii
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`IS1013
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`IS1014
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`IS1015
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`IS1016
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`IS1017
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`IS1018
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`IS1019
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`IS1020
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`IS1021
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`IS1022
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`IS1023
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`IS1024
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`IS1025
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`IS1026
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`Proceeding No. IPR2019-00880
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`Declaration of Victoria Salimov (Served)
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`Declaration of Jacob Munford (Served)
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`Transcript of Remote Deposition of Dr. Shorya Awtar dated
`April 7, 20202
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`US Patent Publication No. 2005/0263562
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`US Patent No. 5,865,361
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`US Patent Publication No. 2005/0279804
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`International Publication No. WO 03/030743
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`LAPAROSCOPIC VASCULAR CONTROL TECHNIQUES IN DONOR
`NEPHRECTOMY: EFFECTS ON VESSEL LENGTH (Bernie et al.)
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`US Patent Publication No. 2005/0006432
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`US Patent No. 5,485,952
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`US Patent No. 6,988,649
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`US Patent No. 5,383,880
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`US Patent Publication No. 2007/0175959
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`In the Matter of Certain Reload Cartridges for Laparoscopic
`Surgical Staplers, Inv. No. 337-TA-1167, Ethicon’s
`Infringement Claim Chart for U.S. Patent No. 7,490,749
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`2 While the document is marked “SUBJECT TO PROTECTIVE ORDER,” the
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`parties subsequently agreed that no redactions are necessary.
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`SureForm60, Stapler User Manual (Instruments and
`Accessories User Manual Addendum)
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`In the Matter of Certain Reload Cartridges for Laparoscopic
`Surgical Staplers, Inv. No. 337-TA-1167, Ethicon’s Opening
`Claim Construction Brief
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`Supplemental Declaration of Dr. Knodel
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`Echelon 60 Endopath Stapler Product Sheet, available at
`https://www.medexsupply.com/images/07-
`0743_EC60ProdSheet.pdf
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`IS1027
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`IS1028
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`IS1029
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`IS1030
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`INTRODUCTION
`The Challenged Claims of the ’749 Patent are invalid because they cover
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`subject matter disclosed in at least three earlier patenting efforts by Ethicon
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`attributed to different inventors. These claims are too late, and they are too broad.
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`Ethicon’s ineffective swear-behind attempt and strained patentability arguments
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`cannot change that. Findings of anticipation and obviousness are the appropriate
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`course.
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` CLAIM CONSTRUCTION
`If the Board adopts any of the §112(6) constructions for “retraction
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`assembly,” “firing drive,” or “closure drive,” the Challenged Claims are anticipated
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`and rendered obvious by Shelton II and Swayze (Grounds 1 and 2). If the Board
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`instead adopts non-§112(6) constructions for these terms, as Ethicon requests, then
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`the Challenged Claims are also anticipated by Shelton I (Ground 3).
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` ARGUMENT
`A. The Challenged Claims Are Anticipated (Grounds 1-3)
`1.
`Ground 1: Shelton II Anticipates Because a POSITA Would
`Have Immediately Envisioned Removal of the Retraction Spring
`Shelton II invites removal of the retraction spring from the surgical instrument
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`of its illustrated embodiments. Pet., 37 (citing IS1003 [Knodel Decl.], ¶¶57-62).
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`For example, at Paragraph [0154], Shelton II states that “a manual retraction
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`mechanism consistent with aspects of the invention may be utilized without the
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`assistance of a retraction spring.” From this disclosure, a POSITA would have
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`immediately envisioned a configuration of Shelton II’s surgical instrument 1010
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`lacking the tension/compression spring 1184 and relying solely on the manual
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`retraction assembly. Pet., 37-38; Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
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`780 F.3d 1376, 1381-83 (Fed. Cir. 2015) (“[A] reference can anticipate a claim . . .
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`if a person of skill in the art, reading the reference, would at once envisage the
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`claimed arrangement or combination.”).
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`Ethicon argues that Shelton II’s Paragraph [0154] is merely a reference back
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`to an earlier part of the specification at Paragraph [0144], and therefore adds nothing
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`to the preceding disclosure. POR, 57-58. Ethicon is mistaken. See IS1029 [Knodel
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`Reply Decl.], ¶¶5-8.
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`Paragraph [0154] is part of a broader discussion by Shelton II beginning at
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`Paragraph [0148]. The discussion opens with the proviso that: “Additional
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`advantages and modifications may readily appear to those skilled in the art.” The
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`paragraphs that follow, including Paragraph [0154], provide concrete examples of
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`this “additional” subject matter. See Shelton II, ¶[0149] (single actuation for firing
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`and closing), ¶[0150] (motorized handle assembly), ¶[0151] (straight-rack firing
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`drive), ¶[0152] (manual retraction without automatic retraction), ¶[0153] (single-
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`stroke firing drive), ¶[0154] (retraction spring removal); IS1029 [Knodel Reply
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`Decl.], ¶6.
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`A POSITA reading Shelton II in full would have recognized that Paragraph
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`[0154] does not simply echo Paragraph [0144]. That would have been redundant.
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`See IS1003 [Knodel Decl.], ¶60. Instead, a POSITA expecting additional subject
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`matter following Paragraph [0148] would have interpreted Paragraph [0154] as
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`identifying a modification of Shelton II’s prior illustrated embodiments. See IS1029
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`[Knodel Reply Decl.], ¶7. Thus, Paragraph [0154]’s disclosure of “a manual
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`retraction mechanism . . . without the assistance of a retraction spring” clearly
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`conveys an instrument that retracts without the previously-disclosed spring. An
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`objective analysis of Shelton II leaves no room for Ethicon’s contrary argument.
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`Ethicon offers four reasons in support of its argument, and each are flawed.
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`First, Ethicon contends the automatic retraction spring is too important for a
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`POSITA to envision its removal. See POR, 58. Shelton II suggests otherwise.
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`Shelton II teaches that automatic retraction is purely optional. Shelton II, ¶[0152]
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`(“[W]hile automatic retraction at the end of firing travel may be desirable, a manual
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`retraction may be incorporated without this feature.”); IS1029 [Knodel Reply Decl.],
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`¶9, fn1 (citing IS1016). Optionality is further implied by Shelton II’s independent
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`claims 1 and 18, each reciting manual retraction components with no mention of
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`automatic retraction. That Ethicon already sought a patent by other inventors
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`disclosing and claiming the same thing—manual retraction without automatic
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`retraction—means that the ’749 Patent is anticipated.
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`Ethicon’s second point fares no better than its first. Here, Ethicon says,
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`“removal of the retraction spring would be inconsistent with the invention of Shelton
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`II, which is an instrument that includes a spring that assists in retraction.” POR, 59.
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`But, again, Shelton II did not confine its disclosure or claimed inventions to an
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`automatic retraction spring. See Shelton II, ¶[0152], cls. 1, 18. A POSITA,
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`therefore, would have appreciated the full breadth of Shelton II and properly
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`interpreted Paragraph [0154] to disclose removal of the optional retraction spring.
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`See Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1322-23 (Fed. Cir. 2005)
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`(reference disclosing optional inclusion of a particular component teaches
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`compositions that both do and do not contain that component).
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`That removal of the retraction spring requires the user “to supply the full force
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`necessary to retract the firing member after each use” would not have prevented a
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`POSITA from immediately envisioning such an embodiment. POR, 59; but see
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`IS1029 [Knodel Reply Decl.], ¶10. Quite the opposite. Shelton II inspires
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`consideration of a spring-less embodiment by explaining how the instrument works
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`when the retraction spring is not functional (i.e., disconnected). See Shelton II,
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`¶[0144]; IS1003 [Knodel Decl.], ¶62; IS1029 [Knodel Reply Decl.], ¶10.
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`Again missing the mark, Ethicon argues in its third point that “removal of the
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`spring would be contrary to the conventional wisdom of endoscopic surgical staplers
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`at the time of the 749 Patent.” POR, 59. The argument fails because it lacks a valid
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`premise. Ethicon’s cherry-picked examples of stapling instruments with retraction
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`springs are not representative of conventional wisdom. Intuitive’s Dr. Knodel notes
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`several countervailing examples with fully manual retraction assemblies. See
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`IS1003 [Knodel Decl.], ¶75; IS1029 [Knodel Reply Decl.], ¶¶11-15 (citing EX2019
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`[Awtar Decl.], ¶97; IS1010; IS1011; IS1015 [Awtar Depo.], 76:18-20; IS1017-
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`IS1022). The example below had even been commercialized before the ’749 Patent.
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`The record evidence shows that both configurations—automatic and manual
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`retraction—were part of conventional wisdom. In fact, as explained by Dr. Knodel,
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`conventional wisdom actually would have encouraged a POSITA to envision
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`Shelton II’s surgical instrument without a retraction spring. See IS1029 [Knodel
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`Reply Decl.], ¶¶16-17 (citing EX2018 [Knodel Depo.], 18:12-19:13; IS1011). Dr.
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`Knodel’s testimony on conventional wisdom is buttressed by more than 30 years of
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`experience designing medical devices, several of which were dedicated to
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`endoscopic severing and stapling devices. See IS1003 [Knodel Decl.], p.101;
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`IS1029 [Knodel Repl. Decl.], ¶25. Dr. Awtar, on the other hand, has never designed
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`a surgical stapler; did not even view a surgical stapler in person until 2007 (near the
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`critical date); and did not operate a surgical stapler until 2014 (long after the critical
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`date). See IS1015 [Awtar Depo.], 25:19-25, 28:14-25.
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`The Challenged Claims are no less anticipated in view of Ethicon’s fourth
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`point that “a POSITA would have understand [sic] that Shelton II would not reliably
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`retract the firing member if the spring were removed from the instrument.” POR,
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`61 (citing EX2019 [Awtar Decl.], ¶¶98-101). “The fact that a [particular
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`configuration] is shown to be less than optimal does not vitiate the fact that it is
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`disclosed.” Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed.
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`Cir. 1998). Even if the law of anticipation took such concerns into account (which
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`it does not), none exist in Shelton II. Dr. Awtar conceded as much during deposition,
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`noting that “[t]here is no reference to a binding problem in the text of the Shelton II
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`patent specification.” IS1015 [Awtar Depo.], 71:3-5. As explained by Dr. Knodel,
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`Dr. Awtar’s speculation that removal of the retraction spring might cause a
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`“binding” of the linked-rack firing drive reflects a fundamental misunderstanding of
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`Shelton II. See IS1029 [Knodel Reply Decl.], ¶¶18-21 (citing EX2019 [Awtar
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`Decl.], ¶¶98-100; Shelton II, [0131-0132]; IS1015 [Awtar Depo.], 68:6-14). And,
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`in any event, Dr. Awtar’s illusory “binding” issue (POR, 54) is a routine engineering
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`problem readily solved by a POSITA. See IS1029 [Knodel Reply Decl.], ¶22. It
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`would not have prevented the POSITA from envisioning removal of Shelton II’s
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`retraction spring.
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`Ethicon cannot escape the record, and the record fully supports that a POSITA
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`would have immediately envisioned Shelton II’s surgical instrument 1010 without
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`tension/compression spring 1184. The facts presently before the Board are similar
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`to those where other panels found anticipation under Kennametal’s “immediately
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`envisage” reasoning. E.g., Polaris Indus. Inc. v. Arctic Cat Inc., IPR2016-01713,
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`Paper 29 at 49-50 (PTAB Feb. 15, 2018) (finding anticipation where a POSITA
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`would have understood a feature shown in one figure applied throughout other
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`figures where the feature was not shown). A finding of anticipation is, therefore,
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`likewise appropriate here.
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`Grounds 1-2: Shelton II and Swayze Each Anticipate When the
`Retraction Spring is Disconnected
`Ethicon’s infringement allegations in parallel proceedings against Intuitive
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`2.
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`confirm that Shelton II and Swayze each anticipate the Challenged Claims. Pet., 38-
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`39, 52-53. If, as Ethicon asserts, the claims read on a device with an automatic
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`retraction mechanism and a manual backup mechanism, both Shelton II and Swayze
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`anticipate by disclosing such a structure. Because the arguments here apply equally
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`to Shelton II and Swayze, we refer to them collectively as the Shelton II/Swayze
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`disclosure.
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`The device accused by Ethicon is a surgical stapling instrument that has both
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`an automatic (i.e., robotically-driven) retraction mechanism and a backup manual
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`retraction mechanism. See IS1007, 14-15; IS1026, 8-10; IS1027, 33-34. When the
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`automatic mechanism fails “due to lack of power or a non-recoverable fault,” the
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`user turns a Manual Release Knob “until the I-beam has returned to the home
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`position.” IS1027, 33-34. Shelton II/Swayze similarly discloses a fully manual
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`retraction assembly that can be actuated by the user when the automatic retraction
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`spring fails (i.e., becomes disconnected).
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`Ethicon now attempts to thread the needle by arguing that the claims only read
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`on an automatic retraction mechanism with a backup manual mechanism if the
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`automatic mechanism does not place a drag on the firing drive before disconnecting.
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`See POR, 53-54. But this distinction is irrelevant because it has no basis in the
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`Challenged Claims. Nowhere do the claims require a retraction mechanism that does
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`not place a drag on the firing drive during firing.
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`On the contrary, claim 1 recites “a retraction assembly . . . interfacing with
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`said firing drive such that manual actuation of said retraction assembly causes said
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`firing drive to generate a sole retraction motion.” According to Ethicon, “[t]he
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`specification of the 749 Patent explicitly defines ‘sole retraction motion’ to mean ‘a
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`retraction motion generated by manipulation of the retraction assembly by the
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`clinician without any assistance from additional springs or other force generating
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`members.’” POR, 23 (citing ’749 Patent, 16:23-28). Ethicon does not dispute that
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`Shelton II/Swayze discloses this “sole retraction motion” limitation when the
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`retraction spring is disconnected. See POR, 52-56.
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`Critically absent from both the claim language and Ethicon’s proposed
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`construction of “sole retraction motion” is any recitation of “not placing a drag on
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`the firing drive.” Instead, Ethicon injects this drag limitation into its construction of
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`“retraction assembly.” POR, 16-17. But nothing about the term “retraction
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`assembly” connotes a lack of “drag on the firing drive.” While the specification of
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`the ’749 Patent does discuss reducing drag on the firing drive in connection with
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`certain embodiments, this feature is not recited in the claims, nor invoked by
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`prosecution disclaimer, nor stated in a lexicographer’s definition. See, e.g., ’749
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`Patent, 4:47-5:30, 5:53-59, 12:9-15, 16:14-19 (identifying a “manual retraction
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`assembly” verses the claims’ broader “retraction assembly”). In patent law, “the
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`name of the game is the claim,” In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir.
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`1998), and “courts must not import limitations into the claims from the
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`specification,” Trading Techs. Int'l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1352 (Fed.
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`Cir. 2010).
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`Ethicon’s arguments in the co-pending ITC proceeding further undermine its
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`position here. There, Ethicon argued, and the Chief ALJ agreed, that:
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`Nowhere does the claim or the specification require, as Respondents
`[Intuitive] propose, that the retraction assembly be the only portion of
`the instrument that is capable of generating a retraction motion. . . There
`is no exclusion of other retraction assemblies that work independently
`from the claimed manual retraction assembly.
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`IS1028, 9 (first emphasis in original); EX2016, 16. Given the prevailing ITC
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`position that the Challenged Claims cover independently functioning automatic and
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`manual retraction assemblies, those same claims must also cover the Shelton
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`II/Swayze configuration—a non-functioning automatic retraction spring that is
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`disconnected from, and thus independent of, a functioning manual retraction
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`assembly. See IS1029 [Knodel Reply Decl.], ¶23. Besides, the Challenged Claims
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`employ the open-ended transition term “comprising,” which “does not exclude
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`additional, unrecited elements,” such as a disconnected retraction spring. Cias, Inc.
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`v. All. Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007).
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`Yet another reason to reject Ethicon’s argument is that Shelton II/Swayze
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`discloses a multi-fire instrument. See IS1029 [Knodel Reply Decl.], ¶23 (citing
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`IS1023). If the spring becomes disconnected during a first fire, subsequent fires of
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`the E-beam through a new cartridge after the spring becomes disconnected are not
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`afflicted by a spring that places a drag on the firing drive. Id. In this multi-fire
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`context, Shelton II/Swayze anticipates even under Ethicon’s “drag on the firing
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`drive” theory. Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir.
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`2013) (“It is well settled that an accused device that sometimes, but not always,
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`embodies a claim nonetheless infringes.” (quotes omitted)); Brown v. 3M, 265 F.3d
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`1349, 1352 (Fed. Cir. 2001) (“That which infringes if later anticipates if earlier.”).
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`Ethicon’s only remaining contention is that with the Shelton II/Swayze spring
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`disconnected, “[t]he linked rack would be prone to binding in certain conditions
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`because it would engage obstructions, thus preventing full retraction as required of
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`the claimed retraction assembly.” POR, 54. Even if this were true (it is not),
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`Shelton/Swayze still anticipates. To the extent Ethicon’s position is that the Shelton
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`II/Swayze instrument would not fulfill the Challenged Claims “in certain
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`conditions,” that does not preempt a finding of anticipation. Anticipation is
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`established by disclosure of a device that meets each claim limitation some of the
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`time. See Broadcom Corp., 732 F.3d at 1333; Brown, 265 F.3d at 1352. On the
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`other hand, if Ethicon’s position is that the Shelton II/Swayze instrument is
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`somehow inoperative when the spring becomes disconnected, Ethicon failed to
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`provide the necessary factual predicate to overcome the procedural hurdle that prior
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`art is presumed enabling. E.g., In re Antor Media Corp., 689 F.3d 1282, 1287-89
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`(Fed. Cir. 2012); Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354-
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`55 (Fed. Cir. 2003). Nor could Ethicon have established such a record. As discussed
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`(see supra Section III.A.1), Dr. Awtar’s “binding” concern is unfounded.
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`3.
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`Ground 3: Shelton I Anticipates Under Ethicon’s Non-112(6)
`Constructions
`Ethicon urges the Board to reject all 112(6) constructions presented by
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`Intuitive. See supra Section II (citing POR, 16-24). If Ethicon’s constructions are
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`adopted, the Petition demonstrates the disclosure of each claim element by Shelton
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`I. See Pet., 57-85. Ethicon does not even attempt to refute Intuitive’s analysis. See
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`POR, 81-82. Should the Board (A) reject Ethicon’s attempt to swear behind Shelton
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`I (see infra Section III.C); and (B) adopt Ethicon’s non-112(6) constructions, the
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`Challenged Claims should be found anticipated.
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`B.
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`The Challenged Claims Are Obvious (Grounds 1-2)
`1.
`The Petition Provides Ample Motivation to Remove the
`Retraction Spring of Shelton II and Swayze
`There would have been no shortage of motivation for a POSITA to remove
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`the retraction spring from the Shelton II/Swayze surgical instrument. The Petition
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`provides several independent reasons in support of this modification, and Ethicon
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`fails to rebut them. Shelton II and Swayze are addressed here in parallel for sake of
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`brevity. All parties agree that these references disclose virtually the same surgical
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`stapling and severing instrument (Pet., 50, POR, 46), and the motivation to combine
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`arguments are similar.
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`Ethicon first rehashes its argument that Paragraph [0154] is not disclosing an
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`“additional” embodiment in which the spring is removed. POR, 67 (Shelton II); see
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`also id., 79-80 (Swayze); Pet., 39-40 (Shelton II), 54-55 (Swayze). We have already
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`explained why this argument is wrong and misreads Shelton II. See supra Section
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`III.A.1; IS1029 [Knodel Reply Decl.], ¶24.
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`Ethicon also argues that a POSITA would not have been motivated to decrease
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`firing force “[b]ecause a POSITA would not have recognized a problem with force
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`to fire” in the Shelton II/Swayze instrument. POR, 68 (Shelton II), 80 (Swayze);
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`Pet., 40-41 (Shelton II), 55-56 (Swayze). However, in the context of an instrument
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`like Shelton II/Swayze with a manually-operated firing trigger, a POSITA would
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`have been motivated to reduce the firing force whether or not the pre-existing force
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`requirement presented a “problem.” See IS1029 [Knodel Reply Decl.], ¶¶25-27
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`(citing IS1024; IS1025). Ethicon’s argument is thus belied by a countervailing point
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`on which both experts agree. According to both Dr. Knodel and Dr. Awtar, a
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`POSITA would have understood that the retraction spring of Shelton II/Swayze
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`places a drag on the firing drive and, therefore, increases the force-to-fire. See
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`IS1003 [Knodel Decl.], ¶¶65-66, 77; EX2019 [Awtar Decl.], ¶¶87 (.067), 111.
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`Ethicon does not refute Dr. Knodel’s testimony that removing the retraction
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`spring would reduce the firing force. See IS1003 [Knodel Decl.], ¶¶67, 78; EX2018
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`[Knodel Depo.], 44:3-9, 60:13-61:15; IS1029 [Knodel Reply Decl.], ¶¶25-27. Nor
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`does Ethicon challenge Dr. Knodel’s testimony that reducing the firing force would
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`have been a design consideration on the mind of a POSITA. Id. A POSITA would
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`have perceived further lowering the firing force to be beneficial, the mitigation
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`measures already employed by Shelton II/Swayze notwithstanding. Id.
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`Next, Ethicon argues that a POSITA would not have eliminated the Shelton
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`II/Swayze retraction spring to reduce the number of parts and lower manufacturing
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`costs because such a modification would sacrifice the “unique functionality”
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`provided by the spring. See POR, 68-69 (Shelton II), 80-81 (Swayze); Pet., 41
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`(Shelton II), 56 (Swayze). One aspect of the “unique functionality” touted by
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`Ethicon is that the retraction spring “enables the instrument to automatically retract
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`the firing member without the user having to take affirmative steps (such as
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`ratcheting a retraction lever).” POR, 68-69. As Dr. Knodel explained during
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`deposition, this theoretical advantage of fewer operational steps via automatic
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`retraction is beneficial only “[i]f it works every time[.]” EX2018 [Knodel Depo.],
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`43:1-4; see also id., 41:11-16. But the Shelton II/Swayze automatic retraction spring
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`doesn’t work every time. See Shelton II, [0014] (manual assistance to the automatic
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`retraction spring), [0144] (the spring may become disconnected); Swayze, [0067]
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`(manual assistance), [0155] (disconnected spring); IS1029 [Knodel Reply Decl.],
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`¶¶28-30.
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` With this context in mind, a POSITA would have viewed
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`the retraction spring as an optional, and non-essential, component that could be
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`removed when outweighed by other design considerations—e.g., costs and
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`manufacturability. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed.
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`Cir. 2006) (“a given course of action often has simultaneous advantages and
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`disadvantages, and this does not necessarily obviate motivation to combine”);
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`IS1015 [Awtar Depo.], 55:20-56:14 (conceding that “affordability” is a valid design
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`consideration, and it can be achieved by reducing part count).
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`Yet another of Ethicon’s arguments is that design choice and common sense
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`would not have motivated selection of the Shelton II/Swayze manual retraction
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`assembly in place of the redundant automatic retraction spring. POR, 69-70 (Shelton
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`II), 78 (Swayze); Pet., 42 (Shelton II), 56-57 (Swayze). Here again, Ethicon
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`references the “unique functionality” of the retraction spring and the alleged
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`“conventional wisdom” to include such a spring. Neither point withstands scrutiny.
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`The automatic retraction spring and the manual retraction assembly are
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`redundant because they provide a solution to the same problem—E-beam
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`retraction—and do so in a functionally equivalent manner—by pulling the linked
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`rack firing drive in a proximal direction. See IS1003 [Knodel Decl.], ¶¶69, 73-75.
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`As discussed (see supra Section III.A.1), automatic and manual retraction were both
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`part of the conventional wisdom, and a POSITA would have appreciated the risk of
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`pairing an automatic retraction spring with the Shelton II/Swayze E-beam firing
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`member absent a manual redundancy. See IS1003 [Knodel Decl.], ¶75; EX2018
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`[Knodel Depo.], 18:12-19:13; IS1029 [Knodel Reply Decl.], ¶¶11-17. A POSITA
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`would have viewed automatic retraction as optional and manual retraction as
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`mandatory in this context. See IS1029 [Knodel Reply Decl.], ¶16-17; IS1015 [Awtar
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`Depo.], 23:20-24:2 (characterizing manual retraction as more reliable than
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`automatic). And, as Dr. Knodel has explained, “adding and removing non-essential
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`mechanisms . . . are merely design choices routinely made by those of ordinary
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`skill.” IS1003 [Knodel Decl.], ¶69; see also id., ¶74.
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`2.
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`Removing the Retraction Spring Leaves the Fundamental
`Principles of Operation Unchanged
`Ethicon’s argument based on In re Ratti that removing the retraction spring
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`from the Shelton II/Swayze instrument changes a fundamental principle of operation
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`is factually baseless and wrong. POR, 70-71 (Shelton II) (citing 270 F.2d 810, 813
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`(C.C.P.A. 1959)), 77 (Swayze). Shelton II/Swayze discloses how the instrument
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`operates in a fully manual retraction mode when the automatic retraction spring is
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`not functioning (i.e., becomes disconnected). E.g., Shelton II, [0144]; Swayze,
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`[0155]. The instrument would operate the same way if the retraction spring were
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`removed. See IS1003 [Knodel Decl.], ¶64. A modification cannot alter the
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`principles of operation in a prior art device if the prior art describes how the device
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`would operate when the modification—removal of an optional feature—is
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`implemented. E.g., In re Umbarger, 407 F.2d 425, 430-31, 56 C.C.P.A. 974 (CCPA
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`1969) (finding Ratti inapplicable where the modified apparatus will operate “on the
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`same principles as before”); Ultratec, Inc. v. CaptionCall, L.L.C., IPR2013-00288,
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`Paper 63 at 21 (PTAB Oct. 30, 2014) (“[Patent Owner] does not explain how the
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`elimination of a feature that is described as exemplary somehow would change [the
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`prior art’s] principle of operation.”).
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`3.
`Conventional Wisdom Supports Obviousness
`Removal of the Shelton II/Swayze retraction spring would not have bucked
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`conventional wisdom, as Ethicon contends. POR, 72 (Shelton II), 77 (Swayze).
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`Fully manual retraction assemblies were well known in the art, just like automatic
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`retraction springs. See IS1003 [Knodel Decl.], ¶75; IS1029 [Knodel Reply Decl.],
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`¶¶11-15 (citing IS1010; IS1011; IS1017-IS1022). And Dr. Knodel’s corroborated
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`and unrebutted testimony establishes that conventional wisdom would have led a
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`POSITA towards a fully manual retraction assembly, not away from it. See IS1029
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`[Knodel Reply Decl.], ¶¶16-17 (referencing EX2018 [Knodel Depo.], 18:12-19:13).
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`4.
`Ethicon Conflates Obviousness and Bodily Incorporation
`Ethicon’s argument that “Shelton II [and Swayze] would not reliably retract
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`the firing member in the absence of the spring” finds no support on this record. See
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`POR, 72 (Shelton II), 77-78 (Swayze). As discussed, there is no evidence to support
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`Dr. Awtar’s speculation that “binding” may occur if the Shelton II/Swayze retraction
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`spring is removed. See Section III.A.1. And, even if the evidence did support Dr.
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`Awtar’s “binding” theory, a POSITA would have readily solved this problem. See
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`id (citing IS1029 [Knodel Reply Decl.], ¶22); see also KSR Int’l Co. v. Teleflex Inc.,
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`Procee
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