`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner
`_____________
`
`Case IPR2018-00933 (Patent 9,084,601 B2)
`Case IPR2018-00934 (Patent 8,998,058 B2)
`Case IPR2018-00935 (Patent 8,991,677 B2)1
`____________
`
`Record of Oral Hearing
`Held September 5, 2019
`_____________
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`
`
`BEFORE: Josiah C. Cocks, Benjamin D.M. Wood, and Matthew S. Meyers,
`Administrative Patent Judges.
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`Case IPR2018-00933 (Patent 9,084,601 B2)
`Case IPR2018-00934 (Patent 8,998,058 B2)
`Case IPR2018-00935 (Patent 8,991,677 B2)1
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`
`
`APPEARANCES
`
`
`ON BEHALF OF PETITIONER:
`STEVEN R. KATZ, ESQUIRE
`RYAN P. O'CONNOR, ESQUIRE
`FISH & RICHARDSON
`1000 Maine Street SW
`Washington, DC 20024
`202-783-2331
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`ANISH R. DESAI, ESQUIRE
`ROBERT S. MAGEE, ESQUIRE
`WEIL, GOTSCHAL & MANGES LLP
`2001 M Street NW
`Suite 600
`Washington, DC 20024
`202-682-7000
`
`
`
` The above-entitled matter came on for hearing on September 5, 2019,
`commencing at 9:29 a.m., at the U.S. Patent and Trademark Office, USPTO
`Madison Building, 600 Dulany Street, Alexandria, VA 22314.
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`Case IPR2018-00934 (Patent 8,998,058 B2)
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`(Proceedings begin at 1:28 p.m.)
` JUDGE COCKS: We're here today for consolidated oral
`argument for three proceedings, IPR2018-00935, '934, and '935
`involving three patents, 9,084,601, 8,998,058, and 8,991,677.
` Would counsel for the Petitioner please introduce
`themselves?
` MR. O'CONNOR: Ryan O'Connor.
` MR. KATZ: And Steven Katz, Petitioner's.
` JUDGE COCKS: All right. Thank you.
` And counsel for the Patent Owner?
` MR. DESAI: Anish Desai.
` MR. MAGEE: And Bob Magee.
` JUDGE COCKS: All right. Thank you.
` Now, as we set forth in the trial hearing order,
`each side has 60 minutes of arguing time. The Petitioner will
`present their case first for both the challenge claims and the
`substitute claims and may reserve rebuttal time. The Patent
`Owner will then argue its opposition to Petitioner's case, and
`Patent Owner may reserve surrebuttal time. Patent Owner will
`then -- I mean, Petitioner will then argue its rebuttal, and
`we will conclude with Patent Owner arguing its surrebuttal.
` So, Mr. O'Connor?
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`Case IPR2018-00935 (Patent 8,991,677 B2)1
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` Actually, before you begin, a point of order. The --
`there are several proceedings involving these saved parties
`and this Panel that are before the Board, and there are
`currently oral arguments set forth, September 18th and October
`17th; is that correct?
` MR. O'CONNOR: That's right. It's correct.
` JUDGE COCKS: There was recently a request from
`Petitioner to go ahead and consolidate cases on October 17th,
`and the Panel was amenable. Did the Patent Owner have any
`objection?
` MR. DESAI: Yeah. No objection.
` JUDGE COCKS: Okay. So that leaves one last point.
`There's currently then one case scheduled for September 18th
`that IPR2018-00936, the Panel wanted to inquire if there'd be
`any procedural efficiency to argue that case on the 17th as
`well. We are mindful, that would be five cases on the 17th,
`which presents potentially understandable difficulty, but --
` MR. DESAI: I just need to confirm that it works for
`the person who is slotted to schedule it.
` JUDGE COCKS: Okay.
` MR. DESAI: To argue that one. But if that's the
`case, we're okay with it.
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` JUDGE COCKS: Mr. O'Connor?
` MR. O'CONNOR: No objection.
` JUDGE COCKS: No objection?
` MR. O'CONNOR: From our side.
` JUDGE COCKS: After you have conferred, if you would
`please go ahead and email the Board, indicating that that
`would be okay?
` MR. DESAI: Absolutely.
` JUDGE COCKS: Okay.
` All right. Mr. O'Connor, the podium is yours. Do
`you wish to reserve any rebuttal time?
` MR. O'CONNOR: Yes, Your Honor. We'd like to
`reserve 30 minutes for rebuttal.
` JUDGE COCKS: 30 minutes, okay.
` MR. O'CONNOR: And I have hard copies of the slides,
`if you'd like.
` JUDGE COCKS: We will take them.
` MR. O'CONNOR: Okay.
` JUDGE COCKS: You may approach. Thank you. Thank
`you. Whenever you are ready, you may begin.
` MR. O'CONNOR: Thank you very much.
` As you noted, Your Honor, the challenged patents are
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`the '601, '058, and '677 Patents, which are related and share
`a common specification and figures. As described in the
`abstract, the challenged patents disclose a detachable
`motor-powered surgical instrument, for example, a surgical
`stapler, that permits power to be supplied to the motor only
`when the housing of the instrument is operably attached to an
`actuator arrangement. In some embodiments, the surgical
`instrument is operably attached to a conventional handheld, a
`surgical cutting and stapling instrument, Label 10. In other
`embodiments, the surgical instrument is operably attached to a
`robotic surgical instrument labelled 1000.
` Slide 3. On December 14, 2018, the Board instituted
`the foregoing IPRs. As demonstrated in the Petitions, each of
`the challenged claims are either anticipated by or obvious
`over prior art that discloses a motor-powered surgical stapler
`that is removably connected to a robotic surgical system,
`controlled by the robotic surgical system, and receives power
`from the robotic surgical system.
` For the '601 Patent, Patent Owner did not file a
`response to the Petition. Instead, Patent Owner filed a
`Motion to Amend that attempts to avoid the prior art by adding
`a requirement to each of the challenged claims, that the motor
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`be coupled to a power source when the instrument housing is
`not coupled to the surgical instrument system.
` Patent Owner has proposed amendments to the claims
`of the '058 and '677 Patent's attempt to achieve the same
`result. And because the Patent Owner did not file a response
`after the Board instituted a review of the first IPR for the
`'601 Patent, I will begin with the substitute claims of the
`'601 Patent and because the prior art -- the same prior art
`applies to the substitute claims of the '058. And '677
`Patents, I'll address all the substitute -- the obviousness of
`the substitute claims together, and then I'll address the
`obviousness of the original claims of the '058 --
` JUDGE COCKS: Counsel, I have a question for you.
` MR. O'CONNOR: Yeah.
` JUDGE COCKS: I think I heard you say that the
`amendments for the three patents attempts to obtain the same
`result. Is it -- did I hear you correctly?
` MR. O'CONNOR: In general, yes.
` JUDGE COCKS: In general? I mean, it's different
`language, but you're saying it's essentially the same?
` MR. O'CONNOR: Yes. So in the '058 and '677
`Patents, the substitute claims require the motor to be
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`configured for attachment to a power source, independent of
`the housing connector attachment to the surgical instrument
`system. So they're slightly different at which --
` JUDGE COCKS: I just wanted to clarify what you had
`said.
` MR. O'CONNOR: Yes, thank you.
` JUDGE COCKS: Thank you.
` MR. O'CONNOR: Slide 6. As explained in the
`oppositions to the Motions to Amend, each substitute claim for
`each patent at issue would have been obvious over Viola in
`view of Heinrich.
` Slide 7. Heinrich, for example, discloses a robotic
`surgical system and the adaptation of various handheld
`surgical instruments for use with the robotic surgical system.
`In addition to the specific examples shown in Figures 9 and
`11, as shown in this slide, Heinrich, in Paragraph 133,
`confirms that the robotic surgical instrument can be based on
`the surgical cutting and stapling instrument shown in Figure 3
`of Heinrich. And Paragraph 135 of Heinrich states, By way of
`example only and in no way to be considered as limiting,
`potential surgical instruments or systems, which can interface
`with robotic system 600, include various hand instruments, for
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`example, stapling or fastener-applying instruments, cutting
`instruments, and/or any combination thereof.
` As explained by Dr. Fischer, a person of ordinary
`skill in the art would have understood that the manual
`actuators of the handheld instruments are replaced with
`Heinrich's electromechanical assembly, which is labelled 619,
`to enable remote actuation of the robotic instruments.
` Slide 8. Notably, Heinrich also discloses that the
`robotic surgical instruments may be powered locally. In
`Paragraph 131 and in Paragraph 137, Heinrich teaches that the
`robotic surgical instrument can include multiple motors to
`actuate the surgical instrument.
` Slide 9.
` JUDGE WOOD: Can I ask a quick question?
` MR. O'CONNOR: Yes.
` JUDGE WOOD: How does Viola's instrument differ from
`the stapler in Heinrich Figure 3?
` MR. O'CONNOR: It differs in a couple ways. The end
`effector of Viola is more or less the same as the end effector
`in Figure 3, which comes from the Milliman Patent. The
`differences, I would say, are in the handle portion.
` So in Heinrich's surgical tool, the instrument
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`includes a variety of actuators. You have an actuator to fire
`the instrument, you have an actuator to articulate the end
`effector, you have an actuator or knob to rotate the end
`effector, and then there's another knob to retract the firing
`mechanism after it has been fired.
` In Viola, you just have the single actuator. It's a
`trigger that's coupled to a switching mechanism that controls
`the flow power between the power source and the motor to try
`the end effector.
` JUDGE WOOD: Okay.
` MR. O'CONNOR: Okay.
` JUDGE WOOD: All right. Thanks.
` MR. O'CONNOR: I may have hit some of this already,
`but Viola, like Heinrich, discloses another handheld surgical
`stapler. Importantly, the housing of Viola surgical stapler,
`which is shown in yellow, houses a motor, which is shown in
`red, and a power source, which is also shown in red. The
`stapler also includes the switching assembly near the back of
`the device with a proximal end that controls the flow of power
`to the motor and is controlled by the manual trigger, which I
`mentioned, which is shown in blue.
` Slide 10. Viola also incorporates the subject
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`matter that's disclosed in the Young Patent, which
`demonstrates that Viola's motor power source and switching
`assembly, which are labelled in Figure 4 on Slide 10, can be
`implemented using components that fit inside just the shaft
`person of the device, which can be two and three times smaller
`than the specific example of a housing that's shown in Figure
`2A of Viola.
` Slide 11. The substitute claims would have been
`obvious over Viola in view of Heinrich for several reasons.
`For example, there was a designed need to provide a way to
`manipulate surgical instruments during a procedure, and there
`are finite number of identified, predictable solutions from
`manipulating a surgical instrument, for example, by hand or
`using a robotic system. Thus, as explained in KSR [ph], the
`device resulting from the proposed combination was likely the
`product not of innovation, but of ordinary skill and common
`sense.
` Slide 12. Furthermore, the prior art disclosed a
`variety of robotic systems, and top that, robotic systems
`increase surgical dexterity compared to handheld tools, and
`may also permit a surgeon to operate on a patient in an
`intuitive manner. Excuse me. For example, US Patent number
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`6783524 to Anderson, which is identified as prior art in the
`challenged patents, discloses the known benefits of robotic
`surgical systems, and, like Heinrich, discloses the adaptation
`of handheld tools for use with the robotic surgical systems.
`Importantly, Anderson teaches a person of ordinary skill in
`the art adapting handheld tools for use with the robotic
`system to use the existing components of the handheld tool to
`reduce costs and to improve manufacturing convenience.
` Slide 14. Applying the teachings of Heinrich to
`Viola, a person of ordinary skill in the art would have
`replaced Viola's manually actuated trigger with Heinrich's
`electromechanical assembly to enable remote actuation of the
`tool and then incorporated the components inside Viola's
`housing into Heinrich's disposable loading unit housing to
`reduce costs and improve manufacturing convenience.
` As explained by Mr. Fischer, the only expert in this
`case that has done any work designing, developing, or using
`the surgical robots and staplers, such a modification of Viola
`would have been well within a person of ordinary skill in the
`art's abilities for several reasons. For example, it would
`have been merely the application of a known technique,
`specifically adapting a handheld surgical instrument for use
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`with a robotic system by replacing the manually actuatable
`trigger with the robotically controlled actuator to known
`system, Viola's instrument, in the same field of endeavor,
`surgical staplers in unknown way, specifically the way that's
`taught by Heinrich, as well as Anderson.
` Furthermore, in combination, each element,
`specifically Heinrich's robot and Viola's instrument, performs
`the same function as it does separately, and the combination
`of Viola and Heinrich proposed here would have yielded
`predictable results without altering or hindering the
`functions performed by Viola's device or Heinrich's robotic
`system.
` JUDGE WOOD: The trigger is basically a switch,
`right?
` MR. O'CONNOR: The trigger -- actually, it's a
`switch. It's a separate switching mechanism in -- you're
`referring to Viola?
` JUDGE WOOD: Yes. So if you substituted Heinrich's
`electromechanical actuation assembly for Viola's trigger,
`would you retain that switching mechanism?
` MR. O'CONNOR: Yes.
` JUDGE WOOD: So why would you need an
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`electromechanical actuation assembly if you're just basically,
`you know, closing a contact? I mean, that's all the trigger
`does, right?
` MR. O'CONNOR: You could replace or actuate the
`switching mechanism using the robotic system as well. We were
`-- the argument is based on the teachings of Heinrich and
`Viola, which, in general, teach the replacement of the manual
`actuator and not necessarily the replacement or actuation of a
`switching assembly inside of a device. So we thought that was
`the most logical approach the person of ordinary skill in the
`art would take.
` JUDGE WOOD: But doesn't Heinrich's control assembly
`already have some kind of mechanism, you know, analogous to
`the trigger, to Viola's trigger?
` MR. O'CONNOR: Can you repeat that question? I'm
`sorry.
` JUDGE WOOD: I'm just wondering. You know, Heinrich
`has a control assembly, and my question is, would Heinrich
`already have something analogous to the trigger?
` MR. O'CONNOR: Something -- yeah. My understanding
`is that the electromechanical assembly is referring to
`something like a servo motor, so that would be similar to a
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`trigger.
` JUDGE WOOD: Again, I'm sorry, but my terminology
`was not completely accurate.
` Heinrich has an actuation assembly, and that's -- my
`understanding is that is what the physician would use to
`control the robot.
` MR. O'CONNOR: I'm sorry. So when you refer to
`actuation assembly, you're referring to the box that is
`actually operated by the physician?
` JUDGE WOOD: Exactly.
` MR. O'CONNOR: Could you -- Slide 7. The box
`labelled 612 in Figure 7?
` JUDGE WOOD: Exactly.
` MR. O'CONNOR: Yeah, okay. And is your question, is
`that component similar to a switch?
` JUDGE WOOD: Right, exactly. I mean --
` MR. O'CONNOR: Yes. Yes. So the point of the
`combination is to allow the surgeon to operate the device
`remotely. So you're moving the functionality of the switch to
`the actuation assembly, 612 in Figure 7 and then adding an
`actuator to the device that can be controlled remotely from
`the actuation assembly.
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` JUDGE WOOD: It just seems like if you're going to
`replace the trigger, the actuation assembly would already have
`something, you know, along those lines, and you wouldn't need
`that electromechanical assembly as part of the combination.
` MR. O'CONNOR: And maybe that's why I'm back to your
`initial question. You could use the switch, for example, on
`the actuation assembly 612 --
` JUDGE WOOD: Right.
` MR. O'CONNOR: -- to control the switch in Viola's
`device.
` JUDGE WOOD: Exactly.
` MR. O'CONNOR: Yes. I think that's certainly
`possible.
` JUDGE WOOD: Okay. All right. All right, thanks.
` JUDGE COCKS: And, Counsel, I have one question.
`This may be self-evident, but the reason we're considering
`Viola is because Heinrich does not account for the limitation
`of said motors coupled to a power source when the said housing
`is not coupled to the surgical instrument system.
` JUDGE WOOD: This is for your --
` JUDGE COCKS: No. This is for the '933 case.
` JUDGE WOOD: Okay.
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` MR. O'CONNOR: For the substitute claims?
` JUDGE COCKS: Substitute.
` MR. O'CONNOR: Yeah.
` JUDGE COCKS: Which I think we're talking about
`right now.
` MR. O'CONNOR: Yes, we are.
` JUDGE COCKS: The reason we're considering Viola is
`because Heinrich does not account for the limitations -- one
`limitation is sought to be added, which is, wherein said
`motor is coupled to a power source when the said housing is
`not coupled to the surgical instrument system.
` MR. O'CONNOR: I would say -- I'll say yes with a
`caveat.
` JUDGE COCKS: Okay.
` MR. O'CONNOR: Heinrich does specifically disclose
`locally-powered instruments. It also contemplates instruments
`that are self-powered.
` JUDGE COCKS: Okay.
` MR. O'CONNOR: But Viola contains the additional
`details of the interaction between the motor and the switching
`assembly that we thought was -- better landed itself to the --
`all of the limitations in the claims.
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` JUDGE COCKS: Okay. All right. Go ahead. Thank
`you.
` MR. O'CONNOR: I think the last point I was going to
`make on the reason for expectations of success is that the
`challenged patents concede that a person of ordinary skill in
`the art would have known how to use a wide variety of
`alternative robotic structures. And then we'll note that
`Patent Owner's reply to Petitioner's oppositions do not
`dispute that the combination of Viola and Heinrich discloses
`every limitation of every substitute claim.
` So, now, I'll turn to the obviousness of the
`original claims in Slide 21. Like the substitute claims, the
`remaining claims of the '058 and '677 Patents are invalid
`because they would have been obvious -- specifically would
`have been obvious over Hooven in view of Heinrich.
` Slide 22. As we previously discussed, Heinrich
`discloses this -- a robotic surgical instrument system and the
`adaptation of various handheld surgical instruments for use
`with that system.
` Slide 23. And like Viola, Hooven discloses a
`handheld motor-powered surgical stapler. In Hooven, however,
`the stapler is removably connected to a controller, which
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`includes the power supply for the motor in the stapler. In
`the proposed combination of Hooven and Heinrich, Hooven's
`handheld stapler would be adapted for use with Heinrich's
`robotic system for essentially the same reasons that a person
`of ordinary skill in the art would have combined Viola with
`Heinrich. And in the resulting system, the functions
`performed by Hooven's controller and monitor would be
`integrated into Heinrich's robotic system.
` As explained by Dr. Fischer, the proposed
`modification of Hooven for use with Heinrich's robotic system
`would have been well within a person of ordinary skill in the
`art's abilities for the same reasons that the proposed
`combination of Viola and Heinrich would have been well within
`a person of ordinary skill in the art's abilities.
` In response to the proposed combination of Hooven
`and Heinrich, Patent Owner proposed constructions of the
`challenged claims that rewrite various limitations to require,
`among other things, a power source that is attached to the
`surgical tool's motor, even when the surgical tool is not
`attached to the surgical instrument system.
` Slide 24. This slide includes a comparison of the
`original claim of the '058 Patent and Patent Owner's proposed
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`construction. The text highlighted in gray is the original
`claim language, and the text highlighted in yellow is the new
`claim language. Thus, it's clear the Patent Owner has simply
`replaced the phrase, Configured to receive power from, with
`the phrase, That it's attached to. They replaced the word,
`only, with a long phrase highlighted in yellow at the end of
`Patent Owner's proposed construction, and they deleted the
`term selectively.
` In addition to improperly reading the term
`selectively out of the challenged claims, Patent Owner's
`proposed construction is clearly inconsistent with the plain
`meaning of the construed terms. Furthermore, in support of
`its argument that the Board should read in a requirement that
`the claim to motor be attached to the power source, Patent
`Owner argues that the claim describes two separate
`limitations, describing two separate connections. However,
`Patent Owner's argument ignores such that language that are
`underlined in Slide 24, which makes clear that the clause,
`Said motor can only selectively receive power from said power
`source when said means for removably attaching said housing to
`the surgical instrument is operably coupled to the surgical
`instrument. It defines the clause, Said motor configure to
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`receive power. Thus, the two clauses are not separate
`limitations, but, rather, only a single limitation.
` Slide 26. Likewise, in Claims 6 and 17 of the '677
`Patent, Patent Owner added the word, Attached, to the claim
`and replaced the word, operably, with the word, electrically.
`In addition to being inconsistent with the plain meaning of
`the term, operably, the term, electrically, is clearly broader
`than the term, operably, because, as explained by Dr. Fischer,
`it's clearly possible for a motor and a power source to have
`an electrical connection that is not operable.
` Furthermore, the construction of operably appears to
`be moot because the motor and power source in the proposed
`combination of Hooven and Heinrich are, in fact, electrically
`disconnected when the housing of the loading unit is not
`attached to the robotic system, and they're also electrically
`connected when the housing of the loading unit is attached to
`the robotic system. Thus, the motor in the proposed
`combination is operably connected to and disconnected from the
`power source, even under Patent Owner's proposed construction
`of operably.
` Slide 28. Furthermore, Patent Owner's proposed
`constructions are inconsistent with the embodiment shown in
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`Figure 3 of the challenged patents, on which Patent Owner
`primarily relies to support his proposed construction. Under
`Patent Owner's proposed construction, the motor must be
`physically attached to the power source when the disposable
`loading unit is not attached to the handheld surgical
`instrument system. However, the specification of the
`challenged patents confirms the opposite is true. As shown
`here, the power source is disconnected from and does not
`attach to the motor when the disposable loading unit is not
`attached to the surgical instrument system. In fact, the
`power source is purposefully detached from the motor and the
`housing, so that the power source can move inside the tools
`housing.
` Not surprisingly, Patent Owner does not cite
`anything in the specification describing the motor as
`physically attached to the power source.
` Similarly, in support of its proposed construction,
`Patent Owner also argued that the motor must be configured to
`receive power independent on whether or not the housing
`connector is attached to the surgical instrument system, but
`the words, Independent on whether or not the housing connector
`is attached to the surgical instrument system, do not appear
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`in the claims or in the specification. In fact, the '058
`Patent clearly teaches the opposite. Again, it specifically
`teaches that the motors configure to receive power dependent
`on whether or not the housing connector is attached to the
`surgical instrument system.
` Slide 29. For the challenged claims of the '058
`Patent, in Claims 1 and 16 of the '677 Patent, Patent Owner's
`proposed construction is also inconsistent with other uses of
`the phrase, configured to receive in the specification. As
`shown in this slide, the tool mounting portion 1300, which is
`shown on the left, it's on Figure 14, is configured to receive
`a corresponding rotary output motion from the tool drive
`assembly at the robotic system, which is shown in Figure 18 on
`the right, but it's clear from the specification that the tool
`mounting portion 1300 is not attached to the tool drive
`assembly of the robotic system when the tool is not connected
`to the robotic system.
` Slide 30. Patent Owner's proposed construction also
`improperly reads out the embodiments described in the
`challenged patents, wherein the motor of the loading unit
`receives power from the surgical instrument system in exactly
`the same way as the proposed combination of Hooven and
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`Heinrich.
` JUDGE COCKS: Well, Counsel --
` MR. O'CONNOR: Yeah?
` JUDGE COCKS: -- would the Patent Owner come back
`and say that, Well, the second -- the alternative embodiment
`is not encompassed by the claims?
` MR. O'CONNOR: That is their position, yeah.
` JUDGE COCKS: All right.
` MR. O'CONNOR: And I would respond that there is
`nothing in the specification, or the file history, or the
`plain language of the claims that excludes this embodiment.
` Slide 31. Finally, Patent Owner relied on the
`testimony of its expert, Dr. Cimino, to support its proposed
`constructions, but Dr. Cimino was not even aware of the
`embodiments in the challenged patents, wherein the motor
`receives power from the surgical instrument system.
` All right. And with that, I'll -- if there are no
`further questions on that part, I'll pass to Mr. Katz.
` JUDGE COCKS: Thank you.
` MR. KATZ: So I'm just going to address the ability
`of the substitute claims apart from the prior art issues, and
`there are three issues. Number one is that the substitute
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