UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`__________________
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`INTUITIVE SURGICAL, INC.,
`Petitioner,
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`v.
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`ETHICON LLC,
`Patent Owner.
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`Case IPR2019-00880
`Patent 7,490,749
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`SUPPLEMENTAL DECLARATION OF DR. BRYAN KNODEL
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`1
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`IS 1029
`Intuitive Surgical v. Ethicon
`IPR2019-00880
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`__________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2019-00880
`Patent 7,490,749
`
`
`
`
`
`SUPPLEMENTAL DECLARATION OF DR. BRYAN KNODEL
`
`
`
`
`
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`1
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`IS 1029
`Intuitive Surgical v. Ethicon
`IPR2019-00880
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`IPR2019-00880
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`I, Bryan Knodel, declare as follows:
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`INTRODUCTION
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`1.
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`I have been engaged as an expert by Fish & Richardson P.C. on behalf
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`of Intuitive Surgical, Inc. (“Intuitive”) for the above-captioned inter partes review.
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`I understand that this proceeding involves United States Patent No. 7,490,749
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`entitled “Surgical Stapling and Cutting Instrument With Manually Retractable Firing
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`Member” attributed to inventors Christopher J. Schall and Chad P. Boudreaux, filed
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`March 28, 2007 and issued February 17, 2009 (the ’749 Patent). I understand that
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`the ’749 Patent is currently assigned to Ethicon LLC (“Ethicon”).
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`2.
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`I understand that this declaration will be submitted in support of
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`Intuitive’s Reply to Ethicon’s Response to the Petition for inter partes review of the
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`’749 Patent. This declaration supplements, and is intended to be read in conjunction
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`with, my declaration in support of Intuitive’s Petition (IS1003, “my Prior
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`Declaration”). In my Prior Declaration, I address many topics, including (but not
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`limited to) my background and qualifications, the level of skill in art, an overview
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`of the ’749 Patent, claim construction, certain legal standards explained to me by
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`Intuitive’s counsel, and a detailed analysis of the prior art against claims 1 and 3 of
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`the ’749 Patent. The opinions and explanations expressed in my Prior Declaration
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`apply equally here.
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` MATERIALS CONSIDERED
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`3.
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`I have reviewed and am familiar with the’749 Patent (IS1001) and its
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`file history (IS1002). I am also familiar with the following prior art used in the
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`Petition: Shelton II (IS1004), Swayze (IS1005), and Shelton I (IS1006). In addition
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`to these items, I have reviewed the Declaration of Dr. Shorya Awtar (EX2019, public
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`version) and the transcript of Dr. Awtar’s deposition (IS1015). I will discuss these
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`and several other documents in detail below.
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` TECHNICAL DISCUSSION
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`4.
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`The analysis and opinions expressed in my Prior Declaration fully
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`explain why each and every feature of the’749 Patent’s claims 1 and 3 is provided
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`in the prior art. I offered additional explanation in my subsequent deposition
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`(EX2018). Dr. Awtar has considered my opinions and offered his own, some of
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`which are inconsistent with my view. I will address some of those points below.
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`The fact that I have not addressed all of Dr. Awtar’s opinions should not be
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`interpreted as agreement with them.
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` A Person of Ordinary Skill in the Art Would Have Immediately
`Envisioned Removal of Shelton II’s Retraction Spring
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`5.
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`I concluded in my Prior Declaration that Shelton II’s instruction at
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`Paragraph [0154] to eliminate the tension/compression spring 1184 (a retraction
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`spring) would have been enough to place such a configuration in the mind of an
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`ordinarily skilled person. IS1003, ¶62. I understand that Dr. Awtar has reached a
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`different conclusion. In Dr. Awtar’s opinion, “a person of ordinary skill would have
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`interpreted Paragraph [0154] to refer to the description in Paragraph [0144] of
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`Shelton II,” which pertains to operation of the device when the retraction spring
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`becomes disconnected. EX2019, ¶92. I preemptively addressed Dr. Awtar’s
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`position in my Prior Declaration. There, I explained that interpreting Paragraph
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`[0154] in a manner that adds nothing of substance to Paragraph [0144] would have
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`been redundant, and therefore incorrect. IS1003, ¶60. The following discussion
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`further expounds on this in view of Shelton II’s surrounding disclosure.
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`6.
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`At Paragraph [0148], Shelton II suggests that the paragraphs to follow,
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`including Paragraph [0154], describe “[a]dditional advantages and modifications
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`[that] may readily appear to those skilled in the art.” As Dr. Awtar pointed out,
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`Paragraph [0144] already alludes to the advantage of a manual backup mechanism—
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`i.e., “the user can actuate the manual retraction mechanism if the spring were to
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`disconnect from the firing drive.” EX2019, ¶92. It would therefore not make sense
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`to interpret Paragraph [0154] as describing the same thing, especially when
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`Paragraph [0148] prepares the reader for additional subject matter.
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`7.
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`Each paragraph following Paragraph [0148] describes something
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`additional—an embodiment modified from those illustrated in Shelton II’s figures
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`and described in the preceding sections of the specification. Paragraph [0149]
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`describes an alternative configuration where a single actuation mechanism is used
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`for both closing and firing operations. The illustrated embodiments have separate
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`triggers for closing and firing. IS1004 [Shelton II], Figure 1 (elements 34/36),
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`Figure 35 (elements 1034/1036). Paragraph [0150] describes an embodiment where
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`“a motorized or otherwise powered handle” replaces the “manually actuated handle”
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`of the illustrated embodiments. Paragraph [0151] indicates that the linked-rack
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`firing drive can be replaced by “a straight rack” firing drive. Paragraph [0152]
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`makes clear that automatic retraction, as described with reference to the illustrated
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`embodiments, “may be desirable” but is not mandatory—i.e., “a manual retraction
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`may be incorporated without this feature.” Paragraph [0153] notes that a “single
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`stroke firing mechanism” can be substituted in place of the “multi-stroke firing
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`mechanism” of the illustrated embodiments.
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`8. With all of these neighboring paragraphs plainly describing subject
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`matter beyond the illustrated embodiments, a person of ordinary skill would not have
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`expected anything different of Paragraph [0154]. From this perspective, when
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`Paragraph [0154] says “a manual retraction mechanism consistent with aspects of
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`the invention may be utilized without the assistance of a retraction spring,” the
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`logical way to interpret this is that the same devices shown and discussed throughout
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`the specification can be provided “without” the retraction spring. Again, it would
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`not make sense to read this statement as referencing a scenario where the retraction
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`spring becomes disconnected, as this was already described at Paragraph [0144] and
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`illustrated at Figure 44.
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`9.
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`Dr. Awtar offers four reasons in support of his mistaken interpretation
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`of Shelton II’s Paragraph [0154]. First, Dr. Awtar says that “Shelton II focuses on
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`the advantages of incorporating the retraction spring,” and therefore the retraction
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`spring is clearly a significant feature” of Shelton II. EX2019 [Awtar Decl.], ¶93.
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`As I noted above, Paragraph [0152] of Shelton II makes clear that the retraction
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`spring is “desirable” but “a manual retraction may be incorporated without this
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`feature.” From the perspective of an ordinarily skilled person, this means the
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`retraction spring is optional1. When paired with Paragraph [0154]’s further
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`statement that “a manual retraction mechanism . . . may be utilized without the
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`assistance of a retraction spring,” it is clear that Shelton II is encouraging a person
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`of skill to consider an embodiment where the optional spring is removed.
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`1 I note that an earlier Ethicon patent publication to Shelton et al. (US 2005/0263562;
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`IS1016) describes a similar device and states: “Retraction of the firing components
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`may be automatically initiated upon full travel. Alternatively, a retraction lever 46
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`may be drawn aft to effect retraction.” IS1016, [0037] That Shelton (the inventor)
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`viewed the automatic and manual retraction mechanisms as viable alternatives
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`further supports my view that Shelton II intended to disclose an alternative fully
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`manual embodiment at Paragraphs [0152] and [0154].
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`10. Dr. Awtar’s second point is that removal of the retraction spring “would
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`significantly alter how the user would operate Shelton II’s device” in that “the user
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`would be required to supply the full force necessary to retract the firing member after
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`each use.” EX2019 [Awtar Decl.], ¶94. This is irrelevant. That a modification
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`would change how the device is operated by a user does not negate the fact that
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`Shelton II discloses such a modification. For example, Shelton II discloses an
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`alternative single-stroke firing mechanism at Paragraph [0153] that would change
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`how the user operates the device—i.e., one stroke of the trigger to fire instead of
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`multiple. And yet, despite this change in operation, a person of skill would have
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`readily envisioned the alternative single-stroke embodiment. Likewise with removal
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`of the retraction spring. This modification of the illustrated embodiments would
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`require the user to manually retract the firing drive every time, yet it is still disclosed
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`at Paragraph [0154]. And, as discussed in my Prior Declaration, a POSITA would
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`have readily envisioned how such a device would have worked because Shelton II
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`describes its operation at Paragraphs [0142-0144]. EX1003, ¶62. Shelton II’s
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`device without a retraction spring would work the same way as when the retraction
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`spring is disconnected. In each instance, the spring has no effect, and the user pulls
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`back on the manual lever to retract the firing drive.
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`11. The third point raised by Dr. Awtar is that “removal of the spring would
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`be contrary to the conventional wisdom of endoscopic surgical staplers at the time
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`of the invention of the 749 Patent.” EX2019 [Awtar Decl.], ¶95. According to Dr.
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`Awtar, “the conventional wisdom was to utilize a spring to assist in retracting the
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`firing member.” EX2019 [Awtar Decl.], ¶95. These statements are inaccurate. The
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`limited examples of endoscopic surgical staplers with automatic retraction springs
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`that Dr. Awtar identified are not representative of the entire state of the art. EX2019
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`[Awtar Decl.], ¶96. By the time of the ’749 Patent, the 2006-2007 timeframe, both
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`automatic retraction and fully manual2 retraction mechanisms were part of the
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`conventional wisdom. I illustrated this point in my Prior Declaration by noting two
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`examples of surgical staplers with fully manual retraction mechanisms—US
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`5,941,442 (IS1010) and U.S. Patent No. 5,865,361 (IS1011)3.
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`12. The ’361 Patent to Milliman et al. (“Milliman”) is of particular interest
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`2 By “fully manual” I mean that the device does not include a spring (or any other
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`force generating component) that provides a retraction force.
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`3 I understand that, during deposition, Dr. Awtar clarified his statement that IS1011
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`(Milliman) “discloses the use of a spring to proximally bias the actuation shaft that
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`advances the firing member.” EX2019 [Awtar Decl.], ¶97. I agree with Dr. Awtar’s
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`statement during deposition that this spring is not a retraction spring, meaning it
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`“does not contribute to a retraction force as one is trying to retraction the firing rod.”
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`IS1015 [Awtar Depo.], 76:18-20.
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`to this discussion of “conventional wisdom.” Like Shelton II and the ’749 Patent,
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`Milliman describes a pistol-grip surgical stapling device suitable for endoscopic
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`procedures. IS1011 [Milliman], Abstract, Figure 1. This particular design, featuring
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`manually actuated “retractor knobs” for retracting an “actuation shaft,” was the
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`subject of multiple patents and patent applications published before the ’749 Patent.
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`E.g., U.S. Patent No. 5,865,361 (IS1017), U.S. Patent Publication No. 2005/0279804
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`(IS1018), International Patent Publication No. WO 03/030743 (IS1019). Milliman’s
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`design was also commercialized under the moniker Endo GIA years before the ’749
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`Patent by U.S. Surgical (and later Tyco, and even later Covidien). I can say from
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`my own personal experience that this was a well-known device.
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`13. Milliman’s design was not the only fully manual pistol-grip endo-
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`stapler sought by U.S. Surgical (as a division of Tyco). U.S. Patent Publication No.
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`2005/0006432 (IS1021), for example, describes an endoscopic severing and stapling
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`device with a manually operated trigger and a “shift ring assembly” that transitions
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`the trigger between firing and retracting modes. IS1021, [0011], [0126], Figures 1,
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`9, 14-16, 29-36. This patent application published on January 13, 2005, more than
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`two years before the ’749 Patent was filed on March 28, 2007.
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`14. Even before the above-discussed pistol grip designs were developed,
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`U.S. Surgical had already patented an endo-stapler with a fully manual retraction
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`mechanism. U.S. Patent No. 5,485,952 (IS1022), for example, describes an
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`endoscopic severing and stapling device with a manually operated handle used for
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`both firing and retracting. IS1022, 7:61-8:5, 9:5-35, Figures 4, 13, 14.
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`15. A person of ordinary skill in the art aware of these U.S. Surgical
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`designs, particularly Milliman’s commercialized pistol-grip instrument, would have
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`appreciated that fully manual retraction mechanisms were deeply rooted in the
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`conventional wisdom of endoscopic surgical staplers, just as automatic retraction
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`springs were.
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`16. On this same topic, the Milliman design is illustrative of a point I raised
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`during my deposition—“spring returns were very common before E-beams and I-
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`beams because the risk to the patient of any malfunction was negligible.” EX2018
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`[Knodel Depo.], 18:12-19:13. Unlike prior designs, an E-beam firing member, such
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`as Shelton II (and Swayze) describes, must be fully retracted to unclamp the jaws of
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`the end effector. That is because an E-beam holds the end effector jaws closed. If
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`the automatic retraction mechanism were to malfunction (e.g., not provide sufficient
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`retraction force or become disconnected), and if there was not a backup manual
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`retraction mechanism, the end effector would have to be surgically removed. For
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`this reason, retraction springs were viewed less favorably after E-beams and I-beams
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`became prevalent than they were before.
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`17. Milliman’s design is consistent with this line of reasoning; it pairs an
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`E-beam firing member (below, left) with a fully manual retraction mechanism, and
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`therefore lessens the risk of having to surgically remove a jammed end effector due
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`to a retraction spring malfunction. In this context, Shelton II’s indication at
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`Paragraph [0152] that the automatic retraction spring is merely an optional feature
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`makes sense, and it further supports my reading of Paragraph [0154] as disclosing
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`an embodiment with the optional retraction spring removed. Such an alternative
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`embodiment certainly would not have gone against conventional wisdom.
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`18. Dr. Awtar’s fourth, and last, point is that “the manual retraction
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`mechanism could not fully retract the firing member in a reliable manner under all
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`conditions” if the retraction spring were removed from Shelton II. EX2019 [Awtar
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`Decl.], ¶98. Dr. Awtar’s reasoning is that “the retraction spring serves to guide the
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`linked rack down into the pistol grip.” [Awtar Decl.], ¶99. This statement is not
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`correct; it reflects a fundamental misunderstanding of Shelton II.
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`19. At Paragraphs
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`[0131-0132], Shelton
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`II explains
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`that
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`the
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`tension/compression spring 1184 (the retraction spring) exerts a retraction force on
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`the firing drive’s linked rack 1200 through a steel band 1192. More specifically,
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`Shelton II says that the tension/compression spring’s non-moving end 1186 is
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`connected to the instrument’s housing 1154 and its moving end 1188 is connected
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`to the proximal end 1190 of the steel band 1192. IS1004 [Shelton II], [0131]. The
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`distal end 1194 of the steel band 1192 is attached to the front (distal) link 1196a of
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`the linked rack 1200. IS1004 [Shelton II], [0132]. To summarize, the retraction
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`force of the tension/compression spring 1184 is applied to the firing drive through
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`the steel band 1192 at the front link 1196a.
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`20.
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`Importantly, the tension/compression spring 1184 does not control
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`movement of the rear (proximal) link 1196d, which is what Dr. Awtar says would
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`potentially engage obstructions and cause a binding condition. EX2019 [Awtar
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`Decl.], ¶100 (“the proximal end of the linked rack would likely engage obstructions
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`that would prevent it from returning to the pistol grip of the handle assembly”). This
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`is because the steel band 1192, which conveys the retraction force from the
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`tension/compression spring 1184, is connected to the opposite, distal end of the
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`linked rack 1200—i.e., link 1196a, not link 1196d. Dr. Awtar was mistaken during
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`his deposition when he said that “the uppermost loop of the spring is connected to
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`the proximal-most link of the linked rack.” IS1015 [Awtar Depo.], 68:6-14. This
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`statement directly contradicts the disclosure from Shelton II at Paragraphs [0131-
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`0132], and it is likely the source of Dr. Awtar’s misunderstanding. To be clear there
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`is no connection between the rear (proximal) link of the linked rack and the retraction
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`spring in any of Shelton II’s embodiments.
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`21. Because Shelton II’s retraction spring does not guide the proximal end
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`of the linked rack, its removal would not lead to the binding problem alleged by Dr.
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`Awtar. If such a problem existed in Shelton II’s device, it would have been present
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`regardless of the retraction spring. But Shelton II’s says nothing about a potential
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`binding problem, which tends to suggest that no such problem exists.
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`22.
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`In any event, even if there were such a binding problem (with or without
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`the retraction spring), a person of ordinary skill would have readily solved it. For
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`example, a track or guide surface built into the housing could be used to direct the
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`linked rack into the handle of the device. This would have been a trivial matter for
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`an ordinarily skilled person to resolve. In fact, I would be surprised to find that such
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`a solution was not already integrated into Shelton II’s device, despite the fact that it
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`is not illustrated in the drawings. The various cross-sections and partial views in
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`Shelton II (and Swazye) do not show every aspect of every component.
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` Disconnection of the Shelton II and Swayze Retraction Spring
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`23.
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`I disagree with two technical points raised by Dr. Awtar related to the
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`disclosure in Shelton II and Swayze indicating that the retraction spring (i.e.,
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`tension/compression spring 1184) may become disconnected. IS1004 [Shelton II],
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`[0144]; IS1005 [Swayze], [0155]. First, I do not agree that the Shelton II/Swayze
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`“retraction system still includes a retraction spring” when the spring has become
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`disconnected. EX2019 [Awtar Decl.], ¶89. When the spring is disconnected it is
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`non-functional and, therefore, not part of any assembly in the device (including the
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`retraction assembly). Second, I do not agree that the retraction spring necessarily
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`“would have placed a drag on the firing drive during firing.”4 EX2019 [Awtar
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`Decl.], ¶89. A person of ordinary skill reading Shelton II/Swayze would have
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`understood that the illustrated embodiments are multi-fire devices. In fact, Shelton
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`II and Swayze each cite U.S. Ser. No. 10/441,565 (now U.S. Patent No. 6,988,649;
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`IS1023) as a source of “greater detail” about the end effector, and this document
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`expressly states that “[i]t is often advantageous to build an end effector for the
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`surgical stapler that is reusable.” IS1023, 1:66-2:8; IS1004 (Shelton II), [0081];
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`IS1005 (Swayze), [0081]. As a result, the reusable Shelton II/Swayze device could
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`4 Not to mention that the ’749 Patent’s claims say nothing about drag on the firing
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`drive.
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`be fired again after the cycle of operation where the retraction spring became
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`disconnected. In this case, the retraction spring would not place a drag on the firing
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`drive.
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` A Person of Ordinary Skill in the Art Would Have Been Motivated
`to Remove the Shelton II/Swayze Retraction Spring
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`24.
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`In my Prior Declaration, I discussed several independent reasons why
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`a person of skill would have been prompted to remove the retraction spring from the
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`illustrated embodiments of Shelton II/Swazye. IS1003, ¶¶64-69 (Shelton II), ¶¶72-
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`79 (Swayze). I understand that Dr. Awtar has contested my rationale and also raised
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`some reasons of his own in support of a conclusion that a person of skill would have
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`lacked motivation. As to Dr. Awtar’s reasons, they are virtually the same as the four
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`points I addressed above at Section III.A. EX2019 [Awtar Decl.], ¶104 (Shelton II),
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`¶¶116-117 (Swayze). My analysis above therefore applies equally here. As to Dr.
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`Awtar’s assessment of the rationale in my Prior Declaration, I will address that
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`below.
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`25. Dr. Awtar criticizes my opinion that a person of skill would have
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`recognized that the Shelton II/Swayze retraction spring increases the firing force of
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`the device, and therefore would have considered removing the spring for the benefit
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`of achieving a lower firing force. EX2019 [Awtar Decl.], ¶104 (Shelton II), ¶126
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`(Swayze). In one aspect, Dr. Awtar suggests that I have no evidence to support this
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`opinion. EX2019 [Awtar Decl.], ¶104. But, as I stated in my Prior Declaration, I
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`know from personal experience that reducing the necessary firing force would have
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`been one of several considerations assessed by a person of ordinary skill. IS1003,
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`¶67. I have been designing medical devices for more than 30 years. And from
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`February of 1990 to December of 1997, I worked at Ethicon designing endoscopic
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`severing and stapling devices of the same general type as the ’749 Patent and the
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`prior art at issue here. I have spent numerous hours discussing these devices with
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`surgeons to understand their point of view from a user perspective. Topics covered
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`in these discussions include: how the device is used during surgical procedures, what
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`features are necessary and desirable, which aspects of a particular design tend to be
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`problematic, etc. I have dedicated even more time addressing the design
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`considerations arising from the surgeons’ feedback. With this background
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`knowledge, I did not need to consult other documents to determine that reducing the
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`force to fire an endo-stapler like Shelton II would be a design consideration that a
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`person of skill would deem beneficial. This is a fundamental principle of designing
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`endoscopic staplers.
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`26. And while I do not need such a document, I have found documents in
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`the patent literature that support my opinion. Ethicon’s U.S. Patent No. 5,383,880
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`(IS1024), for example, describes a powered endoscopic surgical stapler and provides
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`the following illustrative discussion on the subject of firing force:
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`While endoscopic surgical procedures have substantial benefits
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`to the patient, they do present certain problems to the surgeon
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`conducting the procedure. For example, because the active part
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`of the instrument is further removed from the manipulative part
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`of the instrument, any slight movement of that manipulative part
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`is magnified when it reaches the active part. Hence, when placing
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`and forming a staple in tissue, the hand of the surgeon must be a
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`lot steadier during the endoscopic procedure than If that same
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`procedure was done during standard open surgery. . . Hence, in
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`designing endoscopic surgical instruments, considerable effort
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`is made to reduce the force required in order to operate the
`
`instrument and allow the surgeon to have greater control over
`
`the
`
`instrument. Also,
`
`from an engineering standpoint,
`
`considerable design engineering is required to permit function of
`
`the active portion of the instrument given the physical limits of
`
`force and stroke of the surgeon’s hand.
`
`IS1024, 1:49-2:4. As this document illustrates, a person of ordinary skill in the art
`
`would have understood that reducing the force to fire a surgical instrument enhances
`
`the surgeon’s ability to control the end effector, which is of paramount importance
`
`in an endoscopic procedure. Further, the person of skill would have known that
`
`different surgeons have different physical limits in terms of how much firing force
`
`can be comfortably applied without sacrificing end effector control. Thus, designing
`
`for a lower firing force would make the device usable by a greater number of
`
`surgeons.
`
`
`
`19
`
`
`
`IPR2019-00880
`
`27. Another patent application filed by Ethicon before the ’749 Patent—
`
`U.S. Ser. No. 11/343,562 (published as US2007/0175959; IS1025)—further
`
`confirms that lowering the firing force of endo-staplers was a well-known design
`
`consideration. The following discussion is illustrative:
`
`Endoscopic staplers/cutters continue to increase in complexity
`
`and function with each generation. One of the main reasons for
`
`this is the quest for lower force-to-fire (FTF) to a level that all
`
`or a great majority of surgeons can handle.
`
`IS1025, [0021]. As noted in the excerpt above, “the quest for lower force-to-fire”
`
`was continuing to influence the design of endoscopic surgical staplers at the time of
`
`the ’749 Patent. Thus, while the Shelton II/Swayze device incorporates certain
`
`mechanisms to mitigate the firing force, modifications to further reduce it would
`
`have been considered, and viewed as beneficial, by a person of ordinary skill.
`
`28. Another point of critique raised by Dr. Awtar is that removal of the
`
`Shelton II/Swayze retraction spring “could not possibly improve the reliability of
`
`[the] instrument because it would mean that the instrument would have fewer ways
`
`of providing retraction force to return the firing member.” EX2019 [Awtar Decl.],
`
`¶121. In my experience as a designer of endoscopic staplers (and other medical
`
`devices), “reliability” is a broad design consideration that covers more than just the
`
`number of redundancies; it also addresses how consistent the device is from the
`
`surgeon’s point of view—i.e., does the device work the same way every time.
`
`
`
`20
`
`
`
`IPR2019-00880
`
`29. As I explained during my deposition, a manual retraction assembly is
`
`incorporated in the Shelton II/Swayze device because the automatic retraction spring
`
`does not work every time. EX2018, 45:13-47:8; see also id., 41:14-43:4, 44:3-12.
`
`As a result, the Shelton II/Swayze device will work differently under different
`
`circumstances. If the retraction spring can provide sufficient force, automatic
`
`retraction occurs. IS1004 [Shelton II], [0135-0137]; IS1005 [Swayze], [0143-0146].
`
`If the retraction spring cannot provide sufficient force, the user manually retracts
`
`with the assistance of the spring. IS1004 [Shelton II], [0126] (“A manual firing
`
`release lever 1042 allows retraction before full firing travel if desired and allows
`
`assistance to retract in the presence of binding or a failure in the retraction bias.”);
`
`IS1005 [Swayze], [0133]. And if the retraction spring becomes disconnected, the
`
`user manually retracts by providing the full retraction force. IS1004 [Shelton II],
`
`[0144]; IS1005 [Swayze], [0155].
`
`30. This device is unreliable in the sense that the surgeon cannot predict
`
`with certainty how retraction will occur at any given time. On the other hand, if the
`
`retraction spring were removed, the exact same procedure would be performed each
`
`and every time. In my experience, surgeons typically prefer a routine that deviates
`
`as little as possible, even if it requires an extra step, as manual retraction would
`
`compared to automatic retraction.
`
`
`
`21
`
`
`
`IPR20l9-00880
`
`IV. CONCLUSION AND JURAT
`3 1 . I hereby declare that all staternents made herein of rny own knowledge
`
`are true and that all statements made on information and belief are believed to be true.
`
`I further declare that these statements are made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both
`
`(under Section l00l of Title lB of the United States Code).
`
`Executed this 4teday of April, 2020.
`
`22
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`
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