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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________
` )
`INTUITIVE SURGICAL, INC., )
` )
` Petitioner, ) IPR No.
` ) 2018-01254
` vs. )
` ) U.S. Patent No.
`ETHICON, LLC., ) 8,479,969
` )
` Patent Owner. )
` )
`____________________________________)
`
` CONTINUED DEPOSITION OF SHORYA AWTAR, Ph.D.
`
` Washington, D.C.
`
` June 18, 2019
`
` 10:00 a.m.
`
`REPORTED BY: GOLDY GOLD, RPR
`
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` 1
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`Exhibit 1022
`Intuitive v. Ethicon
`IPR2018-01254
`
`
`
`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 2
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` June 18, 2019
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` 10:00 a.m.
`
` Deposition of SHORYA AWTAR, Ph.D., held
`
` at the offices of Weil Gotshal & Manges, 2001 M
`
` Street, NW, Suite 600 Washington, D.C. 20036
`
` before Goldy Gold, a Registered Professional
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` Reporter and a Notary Public within and for the
`
` State of District of Columbia.
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 3
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`A P P E A R A N C E S:
`
` ON BEHALF OF THE PETITIONER:
`
` FISH & RICHARDSON, PC
`
` BY: STEVEN KATZ, ESQ.
`
` One Marina Park Drive
`
` Boston, Massachusetts 02210
`
` E-mail: katz@fr.com
`
` Telephone: (617) 542-5070
`
` ON BEHALF OF THE PATENT OWNER:
`
` WEIL GOTSHAL & MANGES, LLP
`
` BY: CHRISTOPHER MARANDO, ESQ.
`
` 2001 M Street, NW, Suite 600
`
` Washington, D.C. 20036
`
` E-mail: christopher.marando@weil.com
`
` Telephone: (202) 682-7000
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 4
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` I N D E X
`
` EXAMINATION
`
`WITNESS PAGE
`
`SHORYA AWTAR, Ph.D.
`
` By Mr. Katz 5
`
` ******
`
` E X H I B I T S
` PREVIOUSLY MARKED EXHIBITS
`
`PETITIONER EXHIBITS DESCRIPTION PAGE
`
`Exhibit 2005 Declaration of 6
`
` Dr. Shorya Awtar
`
`Exhibit 1008 Wallace patent, 15
`
` Patent No.: US 6,699,235 B2
`
`Exhibit 1014 Giordano application, 6
`
` Pub. No.: US 2008/0167672 A1
`
`Exhibit 1015 Shelton patent, 13
`
` Patent No.: US 6,978,921 B2
`
`Exhibit 1016 Hueil application, 48
`
` Pub. No.: US 2007/0158385 A1
`
` ******
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`Shorya Awtar, Ph.D. - June 18, 2019
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`WHEREUPON,
`
` SHORYA AWTAR,
`
`Called as a witness, having been duly sworn, was
`
`examined and testified as follows:
`
` EXAMINATION
`
`BY MR. KATZ:
`
` Q. Dr. Awtar, welcome back. So this
`
`deposition is going to be captioned for the
`
`IPR2018-01254 case, same patent we discussed
`
`yesterday, the 8,479,969 Patent.
`
` And today we'll be focusing on your
`
`declaration that discusses the arguments based on the
`
`Giordano references primarily.
`
` A. I just have a request: Because of the
`
`noise, the AC noise, can you speak louder?
`
` Q. Yes. And if at any time you didn't
`
`quite hear my question, just ask me to repeat it and
`
`I'll do so.
`
` A. Thank you.
`
` Q. So I've handed you a copy of your
`
`declaration, if you need to reference that. It's
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 6
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`Exhibit 2005 for this proceeding. I've also handed
`
`you IS-1014, which is the Giordano application, which
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`is US2008/0167672.
`
` A. Yes.
`
` Q. I want to direct your attention to a
`
`statement in paragraph 12 of Giordano.
`
` A. Column 12?
`
` Q. Actually, this is an application, so it
`
`has paragraph numbers. You will not find column
`
`numbers.
`
` A. I'm there. Do you want me to read it?
`
` Q. You can read it in a second. I'll just
`
`point you to the passage. It's most-way down the
`
`page, where it says that the upper limit within the
`
`capabilities of most surgeons is usually around 15 to
`
`30 pounds. So if you could read that paragraph, I've
`
`got a question about that statement.
`
` A. If you give me a minute, I'll just read
`
`through it and I'll let you know.
`
` Q. Sure.
`
` A. I have read it.
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 7
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` Q. So in this passage, it states that the
`
`upper limit of most surgeons is usually around 15 to
`
`30 pounds; is that correct?
`
` A. That is what the paragraph states, yes.
`
` Q. Is that referring to the upper limit of
`
`force that a surgeon's hand can apply to a trigger?
`
` MR. MARANDO: Object to form.
`
` A. That's not what it explicitly states,
`
`but that is what my interpretation would be. A force
`
`that a surgeon can apply to -- and by "trigger," I
`
`want to make it clear, perhaps, since we're looking
`
`at the Giordano patent in the context of this patent,
`
`if we look at Figure 1, my understanding is that the
`
`force limit that they are talking about, the 15 to
`
`30 pounds, is the force that a surgeon can apply
`
`between the handle, 26, and the lever, 18, or for
`
`that matter, between the handle, 26, and the lever,
`
`20.
`
` Q. In your own personal experience in
`
`surgical instrument development, is that consistent
`
`with your own understanding?
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 8
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` A. That is actually much higher than
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`anything that I have experienced. And I have direct
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`experience in the design of handles for surgical
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`instruments. The surgical instruments were not
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`endocutters or surgical staplers. They were more
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`traditional instruments, like graspers and needle
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`drivers and things of that nature, so not a stapler.
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` With that context, this number, 30, is a
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`very high number in my experience, but my
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`understanding is that this number is typical of
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`staplers and endocutters. These numbers may not be
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`typical of other instruments, such as shears,
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`graspers, needle holders, and so on.
`
` Q. My understanding of this passage is, and
`
`correct me if I'm wrong, is that it's saying the
`
`upper limit of the force that a surgeon's hand can
`
`apply, regardless of what the instrument is, is
`
`around 15 to 30 pounds?
`
` MR. MARANDO: Objection to form.
`
` A. I would like to point you to just the
`
`context of this paragraph. This paragraph starts
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`Page 9
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`with the statement, quote, Endoscopic
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`staplers/cutters continue to increase in complexity
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`and function with each generation, end of quote.
`
` The rest of the paragraph, it is my
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`understanding, is referring to a particular kind of
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`instrument, and it's in that context that they
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`mention this particular number. Whether this is --
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`you know, irrespective of the kind of instrument, it
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`very well might be, but I read this information,
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`again, in the context of endocutters and staplers.
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` Q. Have you ever, in your experience,
`
`measured the typical upper limit of force that a
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`surgeon's hand can apply to a trigger device,
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`regardless of what the instrument is?
`
` MR. MARANDO: Objection. Scope.
`
` A. I have not measured what a surgeon --
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`how much force a surgeon can provide in their palm.
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`What I have measured is the amount of gripping force
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`needed in a range of surgical instruments. So I've
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`experimentally tested those, or I and my team have
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`experimentally tested those, to determine typically
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`how much force it takes to close the trigger of a
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`handle in a laparoscopic instrument. And then we
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`have taken those instruments to surgeons and asked
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`them to close -- to apply the closure force. And
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`that manner I have, I would say, indirectly assessed
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`that for the instruments that I was testing, the
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`closure force that those instruments required, the
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`surgeons were able to, within reason -- I wouldn't
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`say comfortably, but it was well within their
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`capability to close these instruments -- and those
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`numbers were well within the 30-pound limit.
`
` Q. Did you ever evaluate a linear stapler?
`
` MR. MARANDO: Objection. Scope.
`
` A. I would request just a bit more clarity.
`
`When you say have I ever evaluated, do you mean in
`
`the context of the force that is applied?
`
` Q. Yes. Let me ask a different question.
`
` Have you ever evaluated the force a
`
`surgeon applies to an Ethicon linear stapler?
`
` A. At the handle?
`
` MR. MARANDO: Objection to form.
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 11
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`BY MR. KATZ:
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` Q. At the handle?
`
` A. I did not.
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` Q. Did you understand that Giordano is
`
`suggesting a power assist feature that can be added
`
`to linear staplers?
`
` A. Among other things, yes.
`
` Q. Did you understand that prior staplers
`
`to Giordano, some staplers, including Ethicon
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`staplers, were hand-powered?
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` A. I understand that, yes.
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` Q. And the closure mechanism coupled the
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`closure trigger through some sort of a linkage to a
`
`closure tube that will close the anvil?
`
` MR. MARANDO: Objection. Scope, form,
`
` foundation.
`
`BY MR. KATZ:
`
` Q. Can you answer that question, yes or no?
`
` A. The only thing I would perhaps say
`
`differently, you mentioned through some linkage
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`mechanism, and I would like to broaden that. It
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 12
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`wouldn't just be a linkage mechanism. It could be a
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`combination of various other transmission elements,
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`such as gears, levers, and so on.
`
` Q. But you are familiar with patents prior
`
`to Giordano describing hand-powered staplers where
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`the closure trigger -- the surgeon would apply a
`
`force to a closure trigger, squeeze the trigger, and
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`the result of that is the linear stapler anvil would
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`close?
`
` A. Yes. Yes, I'm aware of -- I'm aware of
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`certain patents, and I'm aware of products that work
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`in that manner, that are purely mechanical.
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` Q. And I am looking for the Shelton
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`reference. One second.
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` So do you have Exhibit 1015 in front of
`
`you?
`
` A. I do.
`
` Q. And so this is a patent we've been
`
`referring as the Shelton reference. There are a
`
`number of Shelton patents. This one is U.S. Patent
`
`6,978,921.
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 13
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` Is it your understanding that this is
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`one of the patents that is incorporated by reference
`
`into Giordano?
`
` A. I believe so.
`
` Q. And from the patents that both you and
`
`Dr. Knodel discussed in your declarations?
`
` A. Yes.
`
` Q. And can you confirm for me that Shelton
`
`discloses a manually actuated closure tube, where a
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`surgeon would squeeze the closure trigger and the
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`result is that the anvil would close?
`
` A. Just give me a moment.
`
` I'm ready to answer. Can you please
`
`repeat the question?
`
` Q. Can you confirm for me that the Shelton
`
`patent marked as IS-1015 is an example of a surgical
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`stapler with a manual closure trigger that works by
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`having the surgeon squeeze the handle, and the result
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`is that the anvil closes?
`
` A. Yes, I agree.
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` Q. And looking back at what Giordano says
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`Page 14
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`by just reading, am I correct to understand that the
`
`surgeon would be able to close that closure trigger
`
`with an upper limit of around 15 to 30 pounds?
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` MR. MARANDO: Objection.
`
` A. Yes, that is what the Giordano patent
`
`says. They do mention that -- they do indicate that
`
`this is -- it's a high force, and that is what
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`perhaps motivates Giordano to investigate a
`
`power-assist patent. But then they point out that
`
`there are certain limitations to power-assist patent
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`also -- a power-assist stapler.
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` Q. Giordano is essentially saying a stapler
`
`like Shelton may be tough to close, so we're going to
`
`propose power-assist to make it easier for surgeons?
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` MR. MARANDO: Objection.
`
` A. That's one of the things that Giordano
`
`says, yes.
`
`BY MR. KATZ:
`
` Q. But the Shelton device is an operable
`
`device, right? They worked?
`
` MR. MARANDO: Objection to form.
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`Shorya Awtar, Ph.D. - June 18, 2019
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`Page 15
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` A. They worked. In a certain context, yes,
`
`they worked.
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` Q. Well, in the context of surgeries,
`
`right?
`
` A. In the context of --
`
` MR. MARANDO: Objection to form.
`
` A. In the context of certain surgeries
`
`where perhaps articulation was not necessary.
`
` Q. I am going to show you what we've marked
`
`as IS-1008, which is the Wallace patent, which is
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`U.S. Patent 6,699,235. Here is a copy.
`
` A. Okay, I think we do have a copy of the
`
`Wallace patent. Okay. I'm looking at the Wallace
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`patent.
`
` Q. If you look at Figure 3?
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` A. I'm looking at Figure 3.
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` Q. And so we're oriented, can you just
`
`identify for me what Item 20 is in Figure 3 of the
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`Wallace patent?
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` MR. MARANDO: Object to form.
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` A. Let me look at the specification.
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`Page 16
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` Item 20 is referred to as a guide tube
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`within the shaft, 52, which is more clearly
`
`illustrated in Figure 2A.
`
` Q. So Figure 3 discloses guide tube, and
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`through the guide are four rods used for
`
`articulation?
`
` A. Yes.
`
` Q. And the shaft is not shown in Figure 3?
`
` A. I don't believe so.
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` Q. In fact, the only components shown in
`
`Figure 3 are components related to articulation; is
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`that correct?
`
` MR. MARANDO: Object to form.
`
` A. I wouldn't agree. I think it would be
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`hard to characterize component 20 as a component
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`related to articulation. I can definitely, without
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`ambiguity, say that the component 12, the distal
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`member, 12, the guide rods, 14, are all related to
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`articulation.
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` Item 20 is just a guide tube, which I
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`think is a tube that stays within the tool shaft, 52.
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` Q. Isn't the purpose of the guide tube to
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`guide and support the rods labeled 14?
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` MR. MARANDO: Objection to form.
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` A. In one instance, it can be.
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` Q. Okay. And if the guide tube's function
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`is to guide and support rods, 14, it would be part of
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`the articulation structure, correct?
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` MR. MARANDO: Object to form.
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` A. Not necessarily. I want to come to that
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`by looking at Figure 2A. In Figure 2A, the tool
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`shaft, 52, supports element 58. Element 58 is the
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`distal end of the articulation joint. So I would
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`consider at least the proximal portion of 58 to be
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`part of the articulation joint, but I wouldn't
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`consider 52 to be part of the articulation joint.
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` Q. And I didn't ask about 52, and I didn't
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`ask about 2A.
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` What I asked was: In Figure 3, if the
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`guide tube supports and guides the articulation rods,
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`wouldn't that serve an articulation function?
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` MR. MARANDO: Objection to form.
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` A. I will repeat the last part of the
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`question. Wouldn't that serve an articulation
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`function?
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` Q. Yes.
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` A. No.
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` Q. Okay. That's fine. That's your
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`testimony.
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` So in your opinion, a guide tube that
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`guides and supports the articulation rods is not
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`related to the function of articulation?
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` MR. MARANDO: Objection to form.
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` A. Can you repeat the last part of the
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`question?
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` Q. Let me ask it again.
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` The Giordano patent states that the
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`guide tube guides and supports the articulation rods
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`labeled 14?
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` A. And can you point out to where, guides
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`and supports?
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` Q. Look at Column 58, around line 5. It
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`says, "There's a guide tube, 20, within shaft, 52,
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`not shown in Figure 3, which guides and supports
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`rods, 14.
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` A. I see that, yes.
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` Q. So let me take it step by step, because
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`I thought I asked an easy question. I didn't expect
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`any pushback. So let's walk it through and figure
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`out what your opinion is.
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` A. And I'm not trying to push back. I'm
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`just trying to be very clear and precise in my
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`answer.
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` Q. Okay. Yes. So guide tube, 20, one of
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`its functions is to guide the articulation rods, 14,
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`right? That's one of its functions?
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` A. Agreed.
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` Q. Another function of the guide tube is to
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`support articulation rods, 14?
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` A. So my opinion, looking at this, is that
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`those two, even though Wallace may have used those
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`terms separately, I don't see what "support" says or
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`would mean any different from "guide."
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` Q. Okay.
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` A. It's a channel. And, in fact, the guide
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`illustrated and shown in Figure 3, has a -- the rod
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`has a rectangular cross-section, and the guide tube
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`has a rectangular opening, and thereby it provides
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`guiding functionality.
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` Q. Isn't part of the way it guides,
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`although not necessarily exclusively -- part of the
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`way it guides, although not perhaps exclusively, is
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`the rods are going to go through the ends of the
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`tube, as shown in Figure 3A, for example, and so if
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`the rod has to go through these little openings at
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`the end, each end of the tube, that will help guide
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`the rod and keep it going in the right direction?
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` A. Yes.
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` MR. MARANDO: Object to form and scope.
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` A. I agree, yes.
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` Q. So in that sense, would you also agree
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`that the guide tube can be considered part of the
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`articulation structure because it is serving the
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`purpose of guiding the articulation rods?
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` MR. MARANDO: Object to form and scope.
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` A. You said can be considered part of the
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`articulation structure. I don't know what that --
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`what you imply by that term "articulation structure."
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`Do you mean articulation joint?
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` Q. No. All I mean by that is it relates to
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`the articulation function.
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` Let me ask it that way: Would you agree
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`that the guide tube, which guides and supports
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`articulation rods, 14, supports the articulation
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`function?
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` MR. MARANDO: Objection to form and
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` scope.
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` A. Yes, to some extent, yes.
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` Q. In that sense, Figure 13 shows elements
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`that all relate to articulation?
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` MR. MARANDO: Objection to form and
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` scope.
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` A. I will say that all relate to
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`articulation -- articulation function.
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` Q. Okay. And the Wallace patent is really
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`about adding articulation to pre-existing
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`instruments; isn't that right?
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` MR. MARANDO: Objection to form.
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` A. I'm not sure of that. Is there a
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`particular line that you would like to refer me to
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`that explains about that?
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` Q. Okay. That was maybe a little too
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`colloquial.
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` Do you understand that the Wallace
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`patent is entitled "Platform Link Wrist Mechanism"?
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` A. Yes.
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` Q. And that the platform link wrist
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`mechanism is a mechanism that provides articulation?
`
` A. Yes.
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` Q. And would you also agree that the
`
`Wallace patent is mostly a discussion of articulation
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`as opposed to every feature of the mentioned surgical
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`instruments?
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` MR. MARANDO: Objection to form.
`
` A. Sir, please repeat.
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` Q. Would you also agree that the Wallace
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`patent is mostly concerning the articulation function
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`as opposed to all the other aspects of a surgical
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`instrument?
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` MR. MARANDO: Objection to form.
`
`BY MR. KATZ:
`
` Q. And I know you're just looking through
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`the figures.
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` Let me just ask you this: Would you
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`agree that most of the figures focus on the
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`articulation function?
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` A. I would agree to that. I do want to say
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`at one point, even though we're past the question --
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` Q. Sure.
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` A. -- the reason I've been hesitating on
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`this guide tube, 20, as to whether it's part of the
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`articulation system or not, I did say that it
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`supports the articulation function.
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` The reason I'm hesitating, or I was
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`hesitating, in that conversation was I didn't find
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`the guide tube to be critical or necessary -- I just
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`want to add that -- to the articulation function.
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`The articulation function could have very well been
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`performed the way intended with or without this guide
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`tube.
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` So in that regard itself, it's a
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`component that goes inside the tube shaft that guides
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`the articulation rods, but I don't see that as a
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`critical or necessary component of the overall
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`system.
`
` Q. I guess all I was trying to clarify is
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`that Figure 3, the components shown in Figure 3 all
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`really relate to articulation?
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` A. "Components support articulation
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`function" is what I said in my previous response.
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` Q. And Figure 3 does not attempt to
`
`disclose all the other aspects of the instrument
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`shaft?
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` MR. MARANDO: Objection to form.
`
` A. No.
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` Q. In fact, the shaft isn't even shown?
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` A. That's correct.
`
` Q. And all the internals that would be
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`running inside the guide tube, other than the
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`articulation rods, are not shown?
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` MR. MARANDO: Objection to form.
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` A. Wallace doesn't discuss anything other
`
`than that, so then that's the extent of what they
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`discussed or they show in any of the facts or any of
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`the figures.
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` Q. We'll be talking about other figures
`
`later, because I think some figures do show some
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`other (unintelligible) details?
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` A. I didn't want to speculate in saying
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`that it doesn't show -- I know what it shows. I
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`don't know what it doesn't show.
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` Q. Actually, as one of ordinary skill in
`
`the art and one of supposedly more than ordinary
`
`skill in the art and one who's read patents, you know
`
`with certainty that Figure 3 does not show the
`
`entirety of the structure being illustrated?
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` MR. MARANDO: Objection to form.
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` Q. That there are components missing from
`
`Figure 3?
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` MR. MARANDO: Objection to form.
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` A. I know that there's a tool shaft missing
`
`from Figure 3, so that would be at least one
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`component that is missing from Figure 3. That is
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`part of the overall system, overall instrument, that
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`is not included in Figure 3.
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` Q. And you know that there's other aspects
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`missing in Figure 3, in addition to the tool shaft,
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`such as control mechanisms that would be running
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`inside the shaft in addition to the articulation
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`functions?
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` MR. MARANDO: Objection to form.
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` A. I don't know if Wallace ever intended
`
`for there to be control functions. Is that described
`
`somewhere in the patent?
`
` Q. Look at Figure 2A. Isn't that
`
`disclosing a gripper?
`
` A. Yes.
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` Q. And even though not shown in 2A,
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`wouldn't there be a control function to open and
`
`close that gripper?
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` MR. MARANDO: Objection to form.
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` A. If the gripper is intended to be
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`controlled, then there should be a control function
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`and appropriate components that would support that
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`function.
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` Q. And given that Wallace is a robotic
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`instrument, wouldn't you expect the gripper to be
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`controlled?
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` MR. MARANDO: Objection to form.
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` A. I would expect the gripper to be
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`controlled in an open/close manner.
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` Q. Therefore, Figure 2A, for example, that
`
`shows the articulation rods but doesn't show the
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`control mechanisms for the gripper, that doesn't mean
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`there are no control mechanisms, right? It just
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`means Figure 2A isn't showing them?
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` MR. MARANDO: Objection to form.
`
` A. What is clear is that Figure 2 is not
`
`showing that. What was the intent of Wallace -- I
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`know one would expect that to be there, but does
`
`Wallace talk about that? I don't know.
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` Q. And again, my question isn't about what
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`Wallace talks about. This isn't a memory test. We
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`can both read Wallace. That's not my question.
`
` What I'm asking you to do is look at
`
`Figure 2A. You're looking at it now?
`
` A. Yes.
`
` Q. And Figure 2A shows a gripper?
`
` A. Yes, I understand.
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` Q. And you understand that Figure 2A shows
`
`a gripper mechanism that's intended to be connected
`
`to a surgical robot?
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` MR. MARANDO: Objection to form.
`
` A. Yes.
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` Q. And you understand from reading patents
`
`that it is common that patents will show in figures
`
`certain components but not all components of the
`
`structure being depicted?
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` MR. MARANDO: Objection to form.
`
` Foundation.
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` A. Anything that is meant to be shown is
`
`generally shown in a patent figure.
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` Q. And this patent figure, Figure 2A, is
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`meant to show the articulation function, right?
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` MR. MARANDO: Object to form.
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` A. I don't know what Wallace meant. And
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`I'll refer to what we said earlier, that this patent
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`focuses on an articulation link, articulation
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`mechanism, and the title of the patent is "Platform
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`Link Risk Mechanism." To that extent, Wallace shows
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`an articulation mechanism.
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` Whether Wallace intended to show a
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`closure mechanism, I don't know. Just because they
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`show a gripper 70, and, in fact, if you give me a
`
`moment, I want to see how they describe 70 and 72.
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` Q. Let's figure that out what 70 and 72
`
`shows, shall we?
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` A. Again, in column 7, line 47, it says,
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`"Grasping jaws are illustrated in Figure 2A, cautery
`
`isolation effector, 72, is shown in Figure 2B." So
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`they mention grasping jaws.
`
` Q. And you understand that grasping jaws
`
`open and close?
`
` A. Yes.
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` Q. That's how you grasp?
`
` A. Yes.
`
` Q. So is it your testimony that you believe
`
`that Wallace intended to disclose an inoperative
`
`device?
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` MR. MARANDO: Objection to form.
`
` A. No. Again, I don't know what Wallace's
`
`intention was. What is clear to me is that Wallace's
`
`intention was to show an articulation joint at the
`
`end effector for an instrument that would be
`
`controlled by a robot. But whether the intention was
`
`to show an inoperable device is -- I don't know.
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` Q. Okay. So your testimony is you don't
`
`know whether Wallace intended it to be operable or
`
`not?
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` MR. MARANDO: Objection to form.
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` A. Yes. That is a very standard thing in
`
`patents. It's not uncommon.
`
` Q. To disclose inoperative devices?
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` MR. MARANDO: Objection to form.
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` A. To disclose devices that one may find or
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`someone else may find inoperative.
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` Q. Okay. So let's just close this out: Is
`
`it your testimony that one of ordinary skill in the
`
`art, looking at F