`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`
`INTUITIVE SURGICAL, INC.
`
`Petitioner
`
`v.
`
`ETHICON LLC
`
`Patent Owner
`
`
`
`
`
`Case IPR2018-00934
`Patent 8,998,058
`
`______________________
`
`
`
`PETITIONER’S SUR-REPLY TO PATENT’S OWNER’S REPLY
`IN SUPPORT OF ITS CONTINGENT MOTION TO AMEND
`
`
`
`
`
`Proceeding No. IPR2018-00934
`Attorney docket No. 11030-0049IP2
`
`UPDATED EXHIBIT LIST
`
`IS1001
`
`U.S. Patent No. 8,998,058 to Moore, et al. (“the ’058 patent”)
`
`IS1002
`
`Excerpts from the prosecution histories of U.S. Pat. Nos.
`9,084,601 (Serial No. 13/832,522), 8,998,058 (Serial No.
`14/282,494), 8,991,677 (Serial No. 14/283,729), 8,752,749
`(Serial No. 13/118,210), 8,196,795 (Serial No. 12/856,099), and
`7,793,812 (Serial No. 12/031,628)
`
`IS1003
`
`Declaration of Dr. Gregory S. Fischer
`
`IS1004
`
`U.S. Patent No. 5,383,880 to Hooven (“Hooven”)
`
`IS1005
`
`U.S. Patent App. Pub. No. 2005/0131390 to Heinrich et al.
`(“Heinrich”)
`
`IS1006
`
`U.S. Patent No. 5,865,361 to Milliman et al. (“Milliman”)
`
`IS1007
`
`U.S. Patent No. 7,524,320 to Tierney et al. (“the ’320 patent”)
`
`IS1008
`
`U.S. Patent No. 8,196,795 to Moore et al. (“the ’795 patent”)
`
`IS1009
`
`U.S. Patent No. 8,752,749 to Moore et al. (“the ’749 patent”)
`
`IS1010
`
`U.S. Patent No. 5,779,130 to Alesi et al. (“Alesi”)
`
`IS1011
`
`[Reserved]
`
`IS1012
`
`IS1013
`
`
`
`
`
`[Reserved]
`
`U.S. Patent No. 6,783,524 to Anderson et al. (“the ’524 patent”)
`
`IS1014-IS1028
`
`Reserved
`
`IS1029
`
`Webster’s Ninth New Collegiate Dictionary (1991)
`
`i
`
`
`
`IS1030
`
`Supplemental Declaration of Gregory S. Fischer (“Fischer
`
`Supp. Decl.”)
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`IS1031
`
`U.S. Pat. No. 5,954,259 to Viola et al. (“Viola”)
`
`IS1032
`
`U.S. Pat. No. 5,653,374 to Young et al. (“Young”)
`
`IS1033
`
`
`
`Transcript of deposition of Dr. William Cimino, May 29, 2019
`
`IS1034
`
`Transcript of deposition of Dr. William Cimino, August 1, 2019
`
`(Cimino Dep. II)
`
`
`
`ii
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`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`I.
`
`The Substitute Claims Introduce New Matter
`
`As explained in the Opposition, the substitute claim language “said motor
`
`configured for attachment to a power source independent of said housing connector
`
`attachment to the surgical instrument system” improperly introduces new matter
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`because the specification discloses no such embodiment but rather teaches the
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`exact opposite—namely, that “attachment” of the power source to the motor (i.e.,
`
`an electrical connection that allows current to flow there between) is dependent on
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`the housing connector’s attachment to the surgical instrument system. Opp., 2-3.
`
`In arguing to the contrary, PO adopts an absurd definition of “attachment,”
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`namely, that even though the specification teaches that the motor and the power
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`source are electrically decoupled when the housing connector is not attached to the
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`surgical instrument system, they nevertheless remain physically attached in that
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`state because “[t]he power source 526 … is attached to the battery holder 524 …,
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`which is in physical contact with the switch portion 520 of the housing connector
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`200 …, which is also in physical contact with the motor.” MTA Reply, 4. In other
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`words, PO is asserting a claim construction of “attachment” that includes indirect
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`physical connections regardless of how many intermediary components are
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`between the two “attached” objects. Dr. Cimino’s testimony demonstrates just
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`how incredible this construction is: Q: “[I]s the Empire State Building attached to
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`the Great Wall of China?” A: “[T]here is … attachment between the two.” Cimino
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`
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`1
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`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`Dep. II, 177:20-178:8. Extrapolating Dr. Cimino’s testimony, PO’s apparent view
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`is that every object is “attached” to every other object on Earth provided there is an
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`indirect physical connection between them no matter how remote. Of course, this
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`definition renders the term “attached” essentially meaningless as it would exclude,
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`presumably, only objects floating in the air. Consequently, PO’s definition of
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`“attachment” logically cannot be correct. As such, the substitute claims introduce
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`new matter because the embodiment contemplated by the substitute claims has no
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`support in the patent.
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`The absurdity of PO’s position is further revealed by its internal
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`inconsistency. If every object on Earth is “attached” to every other object as PO
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`asserts, then it is impossible for the housing to be unattached from the surgical
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`instrument system because there necessarily is an indirect physical connection
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`between them (e.g., the supposedly unattached housing is resting on a table that
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`touches the same floor that the surgical instrument system touches). Even PO’s
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`expert would agree with this conclusion. See Cimino Dep. II, 170:2-7 (testifying
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`that a bottle of water resting on a table is “attached” to the table).
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`However, if the Board adopts PO’s far-fetched definition of “attached,” it
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`must also find that, in the asserted prior art, the motor (e.g., residing in the
`
`housing) remains “attached” to the power source (e.g., residing in the surgical
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`instrument system) independent of the housing connector’s attachment to the
`
`
`
`2
`
`
`
`surgical instrument system because, under PO’s definition, an indirect physical
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`connection exists between them.
`
`II. The Substitute Claims Would Have Been Obvious
`
`PO’s Reply contains no arguments disputing that the proposed combinations
`
`discloses every limitation of every substitute claim. Instead, the Reply argues that
`
`a POSITA would not have been motivated to combine Viola and Heinrich and/or
`
`that the proposed combination would have been beyond the skill level of a
`
`POSITA. Both of these arguments should be rejected.
`
` A POSITA would have been motivated to combine Viola and
`Heinrich
`
`As explained in the Opposition, a POSITA would have been motivated to
`
`combine Viola and Heinrich for numerous reasons. Opp., 5-8. PO’s Reply ignores
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`nearly all of them. Instead, PO selectively identifies certain implementation details
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`(e.g., specific examples of Viola’s motor, batteries, and other internal components
`
`as well as Heinrich’s housing and electro-mechanical assembly), and alleges that
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`Petitioner has not sufficiently explained how to overcome all of the technical
`
`implementation problems that supposedly would arise when combining Viola and
`
`Heinrich. While factually wrong for the reasons discussed in detail below, PO
`
`misses the point.
`
`There is no legal requirement that Petitioner must prove the structures
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`disclosed in Viola and Heinrich could be physically combined to result in an
`
`
`
`3
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`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`operable device. To the contrary, “[i]t is well-established that a determination of
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`obviousness based on teachings from multiple references does not require an
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`actual, physical substitution of elements.” In re Mouttet, 686 F.3d 1322, 1332
`
`(Fed. Cir. 2012). Thus, whether Petitioner (or the prior art in question) has
`
`provided a detailed blueprint for making a working, physical DLU from elements
`
`of Viola and Heinrich, taking into account every technical issue that could arise in
`
`the process, is irrelevant. And PO’s arguments can be rejected on this basis alone.
`
`PO’s arguments can also be rejected because they rely on several incorrect
`
`assumptions. For example, PO incorrectly assumes that the electro-mechanical
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`assembly that replaces or actuates Viola’s trigger is redundant and over-powered
`
`because it can “generate the forces required to effectively cut and fasten tissue.”
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`MTA Reply, 9; see also id. (“Petitioner’s proposed combination results in a
`
`redundant, over-powered motor”), 10 (“additional redundant components”).
`
`Heinrich, however, simply discloses that electro-mechanical assembly 619
`
`“includes mechanisms for moving and operating [generic] surgical tool instrument
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`620.” Heinrich, ¶137. Thus, in Petitioner’s proposed combination, Viola’s trigger
`
`44 would be replaced by or actuated with an appropriately sized electro-
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`mechanical assembly (e.g., a small servo motor) to enable a new function (i.e.,
`
`remote actuation of the loading unit); not a redundant, over-powered motor as PO
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`suggests. Opp. 5-8; see also Cimino Supp. Dep., 210:5-20 (admitting that the
`
`
`
`4
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`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`electro-mechanical assembly in the proposed combination would be smaller and
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`less powerful than Viola’s motor). There is nothing in the Opposition or Dr.
`
`Fischer’s supplemental declaration suggesting otherwise.
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`PO also incorrectly assumes that a POSITA could have “simply attach[ed]
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`Viola’s loading unit to the existing motor of Heinrich.” MTA Reply, 9. Heinrich,
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`however, does not disclose Viola’s surgical instrument and therefore does not
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`disclose a motor, power source, or drive train designed specifically to operate
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`Viola’s surgical tool. Thus, even if a POSITA would have been motivated to
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`replace Viola’s motor, battery, and other internal components with Heinrich’s
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`motor and power source as PO suggests (although PO identified no evidence to
`
`support this theory), that person would have needed to create a loading unit from
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`scratch to perform the same functions as Viola’s tool, modify Heinrich’s robotic
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`system and power source to control and power the loading unit, and deal with the
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`regulatory hurdles associated with an entirely new or substantially modified
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`device. Opp. 5-8; Fischer Supp. Decl., ¶¶48-49. Accordingly, as explained by Dr.
`
`Fischer and confirmed by Anderson, such an endeavor would have been more
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`expensive and complex than simply starting with Viola’s components.1 Id. Or, in
`
`
`1 PO also argues, without any support, that Anderson applies only if OEM parts are
`
`used as cheaper, replacement parts. Anderson, however, is not so limited. Indeed,
`
`
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`5
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`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`PO’s words, there is no scenario where it would be less expensive and less
`
`complex to completely re-design Viola’s motor, power source, gear set, and
`
`switching assembly.
`
`Relatedly, PO appears to assume that a POSITA would not consider “‘a
`
`loading unit attached to a loading unit,’ which is then attached to a robotic
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`system.” MTA Reply, 9.2 If so, PO is incorrect. As shown below in the
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`composite image of Heinrich Figures 3 and 9, the robotic loading unit resulting
`
`from the adaptation of Heinrich’s Figure 3 stapler for use with Heinrich’s robotic
`
`system is a staple cartridge loading unit 316 attached to a robotic loading unit,
`
`which is then attached to a robotic system. E.g., Heinrich, ¶¶92, 133, Figs. 3, 9.
`
`
`in Anderson, the OEM parts from hand-held tools (including motors and power
`
`sources) were used to avoid designing new tools to perform the same functions.
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`2 PO also argues that the proposed combination requires “incorporating a first DLU
`
`with a motor and power source onto a second DLU with its own motor and power
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`source.” MTA Reply, 7. However, Viola’s handle portion 12 (the alleged first
`
`DLU) is not a DLU. And Heinrich’s DLU 618 (the alleged second DLU) does not
`
`include its own power source; it receives power from the robotic system.
`
`
`
`6
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`
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`Staple cartridge
`loading unit 316
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`Mounting flange
`on the arm of the
`robotic system
`
`Robotic loading unit
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`
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`Finally, Patent Owner argues that “the components Petitioner suggests
`
`should be added to the DLU of Heinrich—Viola’s motor and power cells—are
`
`some of the most expensive components in this type of surgical instrument.” MTA
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`Reply, 7. But there are at least two problems with this argument. First, it is
`
`irrelevant. Lack of economic feasibility does not demonstrate non-obviousness.
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`E.g., In re Farrenkopf, 713 F.2d 714, 718 (Fed. Cir. 1983) (“That a given
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`combination would not be made by businessmen for economic reasons does not
`
`mean that persons skilled in the art would not make the combination because of
`
`some technological incompatibility. Only the latter fact would be relevant.”).
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`Second, Patent Owner misunderstands the proposed combination. As taught by
`
`Heinrich, the proposed combination begins with Viola’s hand-held stapler (not
`
`Heinrich’s DLU) and then (1) replaces or actuates Viola’s trigger with Heinrich’s
`
`electro-mechanical assembly, and (2) replaces Viola’s housing with Heinrich’s
`
`
`
`7
`
`
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`DLU housing to configure Viola’s hand-held stapler for use with Heinrich’s
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`robotic system. Opp., 5-8.
`
`
`
`The proposed combination of Viola and Heinrich was well within
`a POSITA’s abilities
`
`PO also argues that combining Viola and Heinrich as proposed by Petitioner
`
`would have posed technical challenges beyond the skill level of a POSITA. MTA
`
`Reply, 11. To support this argument, PO continues its misguided and legally
`
`irrelevant argument that a POSITA would allegedly be unable to physically
`
`combine specific examples of Viola’s motor, batteries, etc. with specific examples
`
`of Heinrich’s DLU housing and electro-mechanical assembly.
`
`PO also incorrectly assumes that the proposed combination requires
`
`“incorporating two motors and two power sources into the DLU of Heinrich.”
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`MTA Reply, 11. As explained above and in the Opposition (at 5-8), the proposed
`
`DLU includes only one power source (Viola’s batteries) because the power source
`
`for Heinrich’s electro-mechanical assembly is in Heinrich’s robotic system.
`
`Moreover, Heinrich explicitly discloses that the DLU may be “powered locally”
`
`(i.e., include a power source) and include more than one motor. Heinrich, ¶¶131,
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`137. In fact, the loading unit based on Heinrich’s Figure 3 embodiment, would
`
`include at least four motors (one to replace each of the stapler’s actuators for shaft
`
`roll, end effector articulation, firing, and retraction). Thus, it is unclear how the
`
`
`
`8
`
`
`
`proposed combination here would have presented any technical challenges that
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`were not already addressed by Heinrich.
`
`Building on its incorrect assumption that the proposed DLU includes two
`
`motors and two power sources, PO further argues that there is “no additional space
`
`to add Viola’s motor, batteries, and additional components” to the head portion
`
`640 of Heinrich’s DLU. MTA Reply, 9-10. However, Heinrich’s loading unit 618
`
`is a generic loading unit. Heinrich, Fig. 7. And Heinrich does not disclose any
`
`limits on the size of its head portion. Cimino Dep. II, 209:21-24 (admitting same).
`
`Relatedly, Patent Owner also argues that Petitioner somehow oversimplified
`
`the challenge of combining Viola and Heinrich by highlighting only the housing,
`
`motor, and batteries as the components that would be added to the DLU of
`
`Heinrich. MTA Reply, 9-10. However, the Opposition clearly states that it would
`
`have been obvious to incorporate “the components inside Viola’s handle portion
`
`12” into Heinrich’s housing and simply identifies the motor assembly 22 and
`
`power cells 45a-b as examples of those components because they are elements of
`
`the substitute claims. Opp., 4.
`
`Moreover, even if a POSITA would have incorrectly assumed that the
`
`components of the proposed DLU are limited to the specific examples shown in
`
`Viola and Heinrich, then the technical challenge would have remained minimal.
`
`Indeed, unlike the proposed DLU’s in Heinrich, which require a POSITA to
`
`
`
`9
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`
`
`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
`
`replace multiple manual actuators (e.g., the two triggers in Heinrich, Fig. 1 or the
`
`trigger, articulation lever, rotation knob, and retraction knob in Heinrich, Fig. 3)
`
`with an electro-mechanical assembly comprising up to four motors, the proposed
`
`DLU here requires the replacement of only one manual actuator (Viola’s trigger)
`
`with an electro-mechanical assembly comprising only one motor. Opp., 5-8.
`
`Furthermore, PO’s expert admitted that: (1) the cylindrical portion of Viola’s
`
`surgical stapler, which includes Viola’s motor, gear set, and switching assembly,
`
`but not batteries, is roughly the same size as the head portion of Heinrich’s
`
`exemplary DLUs (Cimino Dep. II, 218:25-218:9); (2) Heinrich’s electro-
`
`mechanical assembly would be smaller than Viola’s motor (id., 210:5-20) and
`
`therefore fit within the same diameter housing; (3) Heinrich’s electro-mechanical
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`assembly could replace or actuate Viola’s trigger without requiring a significant
`
`redesign of Viola’s other components (id., 224:22-226:25); and (4) as shown
`
`below, Viola’s incorporation of the Young subject matter, discloses a motor,
`
`batteries, and switching assembly for operating an embodiment of Viola’s surgical
`
`stapler that fits entirely within the elongated shaft housing, which PO’s expert
`
`admits could have a diameter that is less than half the diameter of the exemplary
`
`housings show in Heinrich (id., 211:18-212:5).
`
`
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`10
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`
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`Power cells 98a-c
`
`Motor Assembly 86
`
`
`
`Young, Figs. 1, 4.
`
`Switching assembly 130
`
`
`
`Thus, increasing the size of Heinrich’s head portion 640 (e.g., extending it
`
`longitudinally to accommodate Viola’s batteries and/or Heinrich’s electro-
`
`mechanical assembly on the proximal side of Viola’s switching assembly) or
`
`reducing the size of Viola’s components are the only modifications that may have
`
`been required. However, PO’s expert admitted that both were within the level of
`
`skill in the art. Cimino Dep. II, 220:25-221:10, 214:3-14; see also Young, Fig. 4.
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`
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`11
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`Dated: August 13, 2019
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`Respectfully submitted,
`
`/John C. Phillips/
`John C. Phillips, Reg. No. 35,322
`Steven Katz, Reg. No. 43,706
`Ryan O'Connor, Reg. No. 60,254
`Fish & Richardson P.C.
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`T: 858-678-5070
`F: 877-769-7945
`
`
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`Attorneys for Petitioner
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`12
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`Proceeding No. IPR2018-00934
`Attorney Docket No. 11030-0049IP2
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`
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(1) and 42.6(e)(4)(iii), the undersigned
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`certifies that on August 13, 2019, a complete and entire copy of this Petitioner’s
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`Sur-Reply to Patent Owner’s Reply in support of its Contingent Motion to Amend
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`and Exhibit 1034 were provided via email to the Patent Owner by serving the
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`email correspondence addresses of record as follows:
`
`
`Anish R. Desai
`Elizabeth Stotland Weiswasser
`Robert S. Magee
`Adrian Percer
`Christopher T. Marando
`Christopher M. Pepe
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`
`Email:
`
`Ethicon.IPR.Service@weil.com
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`/Diana Bradley/
`Diana Bradley
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`(858) 678-5667
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