UNTIED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INTUITIVE SURGICAL,
`
`INC.,
`
`Petitioner,
`
`v.
`
`ETHICON LLC,
`
`Patent Owner
`
`CERTIFIED COPY
`
`IPR2019-00880
`
`U.S. Patent No. 7,490,749
`
`eetaeNaeeeNeNeNeSeSeeSee
`
`No. 20-90236
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`
`SUBJECT TO PROTECTIVE ORDER
`
`REMOTE DEPOSITION OF
`
`SHORYA AWTAR, PH.D.
`
`TUESDAY, APRIL 7, 2020
`
`Reported by:
`CINDY L. SEBO, RMR, CRR, RPR, CSR, CCR,
`CLR, RSA, LiveDeposition Authorized Reporter
`
`S THE SULLIVAN GROUP
`
`OF COURT REPORTERS
`SULLIVANCOURTREPORTERS.COM
`
`PHONE 855.525.3860 | 323.938.8750
`
`1
`
`IS 1015
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`IS 1015
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`1
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INTUITIVE SURGICAL,
`
`INC.,
`
`Petitioner,
`
`v.
`
`ETHICON LLC,
`
`Patent Owner
`
`CERTIFIED COPY
`
`IPR2019-00880
`
`U.S. Patent No. 7,490,749
`
`eetaeNaeeeNeNeNeSeSeeSee
`
`No. 20-90236
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`
`SUBJECT TO PROTECTIVE ORDER
`
`REMOTE DEPOSITION OF
`
`SHORYA AWTAR, PH.D.
`
`TUESDAY, APRIL 7, 2020
`
`Reported by:
`CINDY L. SEBO, RMR, CRR, RPR, CSR, CCR,
`CLR, RSA, LiveDeposition Authorized Reporter
`
`S THE SULLIVAN GROUP
`
`OF COURT REPORTERS
`SULLIVANCOURTREPORTERS.COM
`
`PHONE 855.525.3860 | 323.938.8750
`
`1
`
`IS 1015
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`IS 1015
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`1
`
`
`
`·1· · · · · ·UNTIED STATES PATENT AND TRADEMARK OFFICE
`
`·2· · · · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`·3
`
`·4· · INTUITIVE SURGICAL, INC.,· ·)
`· · · · · · · · · · · · · · · · · )
`·5· · · · · · · Petitioner,· · · ·)
`· · · · · · · · · · · · · · · · · )
`·6· · · · · · · v.· · · · · · · · )· IPR2019-00880
`· · · · · · · · · · · · · · · · · )· U.S. Patent No. 7,490,749
`·7· · ETHICON LLC,· · · · · · · · )
`· · · · · · · · · · · · · · · · · )
`·8· · · · · · · Patent Owner· · · )
`· · · ____________________________)
`·9
`
`10
`
`11
`
`12· · · · · ·CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`
`13· · · · · · · · · SUBJECT TO PROTECTIVE ORDER
`
`14· · · · · · · · · · · REMOTE DEPOSITION OF
`
`15· · · · · · · · · · · ·SHORYA AWTAR, PH.D.
`
`16· · · · · · · · · · ·TUESDAY, APRIL 7, 2020
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`· · ·Reported by:
`24· ·CINDY L. SEBO, RMR, CRR, RPR, CSR, CCR,
`· · ·CLR, RSA, LiveDeposition Authorized Reporter
`25· ·No. 20-90236
`
`2
`
`
`
`·1· · · · · · · · · · ·A P P E A R A N C E S:
`
`·2· · · · · · · · ·(All Via Video Teleconference)
`
`·3· ·COUNSEL FOR PATENT OWNER:
`
`·4· ·BY - CHRISTOPHER M. PEPE, ESQ.
`
`·5· ·WEIL, GOTSHAL & MANGES LLP
`
`·6· ·2001 M Street, Northwest, Suite 600
`
`·7· ·Washington, D.C. 20036
`
`·8· ·Christopher.pepe@weil.com
`
`·9
`· · ·COUNSEL FOR PETITIONER:
`10
`· · ·BY - ROGER A. DENNING, ESQ.
`11
`· · ·FISH & RICHARDSON
`12
`· · ·12390 El Camino Real
`13
`· · ·San Diego, California 92130
`14
`· · ·denning@fr.com
`15
`· · · · · · -and-
`16
`· · ·BY - KENNETH W. DARBY, ESQ.
`17
`· · ·111 Congress Avenue, Suite 810
`18
`· · ·Austin, Texas 78701
`19
`· · ·kdarby@fr.com
`20
`· · · · · · -and-
`21
`· · ·BY - JOSHUA A. GRISWOLD, ESQ.
`22
`· · ·1717 Main Street, Suite 5000
`23
`· · ·Dallas, Texas 75201
`24
`· · ·griswold@fr.com
`25
`
`3
`
`
`
`·1· · · · · · · · · · · · · · ·INDEX
`
`·2
`
`·3· ·SHORYA AWTAR, PH.D.· · · · · · · · · · · · · · PAGE
`
`·4· · · · BY MR. KATZ· · · · · · · · · · · · · · · · ·4
`
`·5· · · · BY MR. PEPE· · · · · · · · · · · · · · · · 79
`
`·6
`
`·7
`
`·8· · · · · · · · · · ·(No Exhibits Marked.)
`
`·9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`4
`
`
`
`·1· · · · · · · · · · P R O C E E D I N G S
`
`·2
`
`·3· · · · · · · · · · · Remote Deposition
`
`·4· · · · · · · · · ·April 7, 2020; 10:02 a.m.
`
`·5
`
`·6· · · · ·(It is stipulated no party to the litigation
`
`·7· ·will object to the remote deposition on the grounds
`
`·8· ·that the certified stenographer may not have the
`
`·9· ·legal authority to swear in the witness.)
`
`10
`
`11· · · · · · · · · · · · · ·-· - -
`
`12· · · · · · · · · · ·SHORYA AWTAR, PH.D.,
`
`13· · · · ·after having been first duly sworn remotely
`
`14· · · by the certified stenographer, was examined and
`
`15· · · · · · · · · ·testified as follows:
`
`16· · · · · · · · · · · · · ·-· - -
`
`17· · · · · · · · · · · · · ·-· - -
`
`18· · · · · · EXAMINATION BY COUNSEL FOR PETITIONER
`
`19· · · · · · · · · · · · · ·-· - -
`
`20· · BY MR. KATZ:
`
`21· · · · ·Q.· · ·Welcome, Dr. Awtar.
`
`22· · · · · · · · So I understand that you've provided
`
`23· · a declaration in this particular IPR proceeding
`
`24· · which involves U.S. Patent 7,490,749.
`
`25· · · · ·A.· · ·That is correct.
`
`5
`
`
`
`·1· · · · Q.· · ·And as part of your analysis, you
`
`·2· ·discussed an actual prototype instrument that you
`
`·3· ·had physically handled and inspected?
`
`·4· · · · A.· · ·That is correct.
`
`·5· · · · Q.· · ·All right.· And so I take it you were
`
`·6· ·not involved in the design of that physical
`
`·7· ·instrument?
`
`·8· · · · A.· · ·I was not involved in the design of
`
`·9· ·that prototype instrument.
`
`10· · · · Q.· · ·And you were not involved in the
`
`11· ·manufacture of that prototype instrument?
`
`12· · · · A.· · ·I was not involved in the
`
`13· ·manufacturing.
`
`14· · · · Q.· · ·And I take it you first saw the
`
`15· ·prototype instrument in, what, this year, 2020?
`
`16· · · · A.· · ·That is right, yes.
`
`17· · · · Q.· · ·All right.· Did you get the prototype
`
`18· ·instrument from a person at Ethicon or from a
`
`19· ·person at Ethicon's outside law firm?
`
`20· · · · A.· · ·I think -- I think it was the outside
`
`21· ·law firm at the Weil office in Washington, D.C.
`
`22· · · · Q.· · ·Okay.· So you inspected the
`
`23· ·instrument at the Weil office in
`
`24· ·Washington, D.C.?
`
`25· · · · A.· · ·That is correct.
`
`6
`
`
`
`·1· · · · Q.· · ·Okay.· On one occasion or more than
`
`·2· ·one occasion?
`
`·3· · · · A.· · ·At least one occasion.· It could have
`
`·4· ·been more than one occasion, but at least one
`
`·5· ·occasion.
`
`·6· · · · Q.· · ·Okay.· So at this time, you only
`
`·7· ·recall one occasion?
`
`·8· · · · A.· · ·I've had multiple meetings -- I've
`
`·9· ·had multiple meetings at Weil office, multiple
`
`10· ·interactions, multiple times that I've looked at
`
`11· ·multiple prototypes.· And, therefore, I mean, I
`
`12· ·can't count the number of times I've held that
`
`13· ·particular instrument in my hand.· At least once,
`
`14· ·likely more.
`
`15· · · · Q.· · ·And did you arrange for the CT scans
`
`16· ·of the instrument, or were you provided scans?
`
`17· · · · A.· · ·I did not personally arrange for the
`
`18· ·CT scans.· I was provided those scans by -- by
`
`19· ·the Weil attorneys.
`
`20· · · · Q.· · ·All right.· Do you know where those
`
`21· ·CT scans were created, where -- where the scans
`
`22· ·took place?
`
`23· · · · A.· · ·The actual lab?· That -- I do not
`
`24· ·have a recollection of the actual facility or lab
`
`25· ·that conducted that CT scan.
`
`7
`
`
`
`·1· · · · Q.· · ·Okay.· Do you know when the CT scans
`
`·2· ·were created?
`
`·3· · · · A.· · ·I would -- I can -- my recollection
`
`·4· ·is that it's within the last year.· The exact
`
`·5· ·date I would not be able to -- to recall.
`
`·6· · · · Q.· · ·Okay.· And other than the attorneys
`
`·7· ·representing to you that the CT scans were of the
`
`·8· ·instrument that you held and you have pictures of
`
`·9· ·in your declaration, do you have any independent
`
`10· ·knowledge yourself to confirm that the CT scans
`
`11· ·are, in fact, scans of the identical physical
`
`12· ·instrument that you held and placed pictures of
`
`13· ·in your declaration?
`
`14· · · · A.· · ·Well, there is some -- there are
`
`15· ·aspects of the instrument that I held in my hand,
`
`16· ·and I inspected and I used it.· And then when I
`
`17· ·compare that to the CT scans, the two, in terms
`
`18· ·of the outwardly visible components and the
`
`19· ·instrument and the components that I see in the
`
`20· ·scan, they -- they all correlate, as I would
`
`21· ·expect.
`
`22· · · · · · · ·So there was nothing that would make
`
`23· ·me question or wonder whether the scan was a scan
`
`24· ·of the instrument that I've held, but it -- do I
`
`25· ·think -- I didn't take those scans myself --
`
`8
`
`
`
`·1· ·since I didn't coordinate the scan myself, you
`
`·2· ·know, I -- I cannot say that this is -- the scan
`
`·3· ·is -- is that exactly of the instrument, but
`
`·4· ·there's no reason for me to -- to think
`
`·5· ·otherwise.
`
`·6· · · · Q.· · ·Okay.· And do you have a copy of your
`
`·7· ·declaration handy?
`
`·8· · · · A.· · ·I do, yes.
`
`·9· · · · Q.· · ·Okay.· And because we're only going
`
`10· ·to be discussing exhibits that are in the patent
`
`11· ·record of this IPR, I'm not going to be marking
`
`12· ·any exhibit numbers; I'll just simply be
`
`13· ·referring to exhibits that have already been
`
`14· ·filed.
`
`15· · · · · · · ·Do you understand that?
`
`16· · · · A.· · ·I do.· And for that -- for that
`
`17· ·reason, can you reference the exhibit number,
`
`18· ·even though I know what you're talking about,
`
`19· ·just to confirm?
`
`20· · · · Q.· · ·Right.· So, first, I'm going to
`
`21· ·discuss Exhibit 2019, which is your declaration.
`
`22· · · · A.· · ·I have that open in front of me.
`
`23· · · · Q.· · ·Okay.· If you turn to Paragraph 24,
`
`24· ·please, and the last half of that paragraph,
`
`25· ·which is on Page 15 of your declaration.
`
`9
`
`
`
`·1· · · · · · · ·MR. KATZ:· We'll just pause one
`
`·2· · · · minute.· I have a question for the court
`
`·3· · · · reporter.
`
`·4· · · · · · · ·(Pause.)
`
`·5· ·BY MR. KATZ:
`
`·6· · · · Q.· · ·Dr. Awtar, look at -- if we look at
`
`·7· ·Paragraph 24 of your declaration.
`
`·8· · · · · · · ·Just let me know when you're there.
`
`·9· · · · A.· · ·I'm there.
`
`10· · · · Q.· · ·Okay.· And at the end of that
`
`11· ·paragraph, you say -- and I'm quoting --
`
`12· ·Accordingly, the jaws cannot be reopened until
`
`13· ·the firing member is fully retracted to its
`
`14· ·proximal position in the end effector.· This
`
`15· ·mandates an effective mechanism for assuring that
`
`16· ·the firing member can fully retract after each
`
`17· ·use.
`
`18· · · · · · · ·Do you see that text?
`
`19· · · · A.· · ·Yes.
`
`20· · · · Q.· · ·And there are -- you know, you're
`
`21· ·basically saying that if, in fact, you have an
`
`22· ·instrument where the jaws can't open -- excuse
`
`23· ·me.· Let me be more precise.
`
`24· · · · · · · ·If you have a surgical stapler where
`
`25· ·the jaws cannot open until the firing member is
`
`10
`
`
`
`·1· ·retracted, it's very important to have an
`
`·2· ·effective mechanism to be able to retract that
`
`·3· ·firing member because, otherwise, you could be in
`
`·4· ·a situation where you can't open the jaws?
`
`·5· · · · · · · ·MR. PEPE:· Object to the form.
`
`·6· · · · · · · ·THE WITNESS:· Yeah.
`
`·7· · · · · · · ·And I'll -- I'll restate what I
`
`·8· · · · said in my report.· I think -- this is a
`
`·9· · · · clear statement -- that the jaws cannot be
`
`10· · · · open until the firing member is fully
`
`11· · · · retracted to its proximal position in the
`
`12· · · · effector all the way to the back.
`
`13· · · · · · · ·This effectively requires that
`
`14· · · · there is a -- a reliable mechanism for
`
`15· · · · assuring that the firing member can be
`
`16· · · · fully retracted after each use so that,
`
`17· · · · subsequently, jaws can be opened.
`
`18· ·BY MR. KATZ:
`
`19· · · · Q.· · ·Right.· And I guess this sort of
`
`20· ·statement, would you agree, applies to any linear
`
`21· ·surgical stapler where the jaws cannot open until
`
`22· ·the firing member is fully retracted?
`
`23· · · · A.· · ·I would not reach that conclusion.
`
`24· · · · · · · ·This is a description here of the
`
`25· ·retraction assembly in the '749 patent, and
`
`11
`
`
`
`·1· ·that -- it's a description of the '749 patent.
`
`·2· · · · · · · ·Does this description hold true of
`
`·3· ·every surgical stapler?· I would -- yeah, I would
`
`·4· ·not make that statement.
`
`·5· · · · Q.· · ·All right.· Let me be a little more
`
`·6· ·precise, then.
`
`·7· · · · · · · ·I have a surgical stapler that has an
`
`·8· ·I-beam instead of an E-beam, for example, but the
`
`·9· ·I-beam needs to be fully retracted before the
`
`10· ·jaws can open.
`
`11· · · · · · · ·Would you agree in that circumstance
`
`12· ·it would be important to have an effective
`
`13· ·mechanism to ensure that the firing member can be
`
`14· ·fully retracted after each use?
`
`15· · · · · · · ·MR. PEPE:· Object to form.
`
`16· · · · · · · ·THE WITNESS:· So I would like to
`
`17· · · · just request restating that question, if
`
`18· · · · you could do it just a bit slowly.· I want
`
`19· · · · to just follow every step of the question.
`
`20· ·BY MR. KATZ:
`
`21· · · · Q.· · ·Sure.· I'll break it down -- or maybe
`
`22· ·we'll try it in reverse.
`
`23· · · · · · · ·Are you stating in this paragraph
`
`24· ·that the reason you need an effective mechanism
`
`25· ·to ensure that the firing member is fully
`
`12
`
`
`
`·1· ·retracted after each use is specifically because,
`
`·2· ·in this design, you can't open the jaws until the
`
`·3· ·firing member is fully retracted?
`
`·4· · · · · · · ·MR. PEPE:· Same objection.
`
`·5· · · · · · · ·THE WITNESS:· Just give me a moment
`
`·6· · · · to review and I'll get back as soon as I
`
`·7· · · · can.
`
`·8· · · · · · · ·(Whereupon, the witness reviews
`
`·9· · · · · · · · the material provided.)
`
`10· · · · · · · ·THE WITNESS:· So this particular
`
`11· · · · design is one that makes use of an E-beam
`
`12· · · · firing member.· And the E-beam firing
`
`13· · · · member has certain features that engage
`
`14· · · · with both -- both components of the jaw:
`
`15· · · · the -- the cartridge holder channel as
`
`16· · · · well as the anvil.
`
`17· · · · · · · ·And if the firing member is
`
`18· · · · somewhere in a partially fired position,
`
`19· · · · then because of those features on -- on
`
`20· · · · the E-beam firing element, it would not be
`
`21· · · · physically possible to open the jaws in
`
`22· · · · the particular design that we are
`
`23· · · · evaluating -- that I'm evaluating, as is
`
`24· · · · shown in the '749 patent.
`
`25· · · · · · · ·That is what I'm saying.· That is
`
`13
`
`
`
`·1· · · · what I implied by this paragraph.
`
`·2· ·BY MR. KATZ:
`
`·3· · · · Q.· · ·Okay.· And I guess the only thing I'm
`
`·4· ·trying to clarify is the issue you're talking
`
`·5· ·about is that the top of the E-beam will hold the
`
`·6· ·jaws closed unless it's fully retracted?
`
`·7· · · · A.· · ·Unless -- unless it is fully
`
`·8· ·retracted to the point that -- that that
`
`·9· ·particular feature on the E-beam, the topmost pin
`
`10· ·on the E-beam, is no longer engaged with the --
`
`11· ·the mating feature -- the corresponding feature
`
`12· ·on the anvil.· It has to be retracted far enough
`
`13· ·so that that engagement doesn't happen.
`
`14· · · · · · · ·And once it's retracted far enough to
`
`15· ·its fully retracted position, that engagement
`
`16· ·doesn't happen, and then the jaws can be opened.
`
`17· · · · Q.· · ·Okay.· And so this is a feature with
`
`18· ·a linear stapler with an E-beam whereby if the
`
`19· ·E-beam is not fully retracted, the top of the
`
`20· ·E-beam will hold the jaws closed?
`
`21· · · · A.· · ·It is -- it is a feature of the
`
`22· ·E-beam in the particular patent that I am
`
`23· ·analyzing.
`
`24· · · · · · · ·If the exact same design were to be
`
`25· ·repeated in a different device or a different
`
`14
`
`
`
`·1· ·instrument or a different patent, then a similar
`
`·2· ·argument or similar logic may be extended.
`
`·3· · · · · · · ·I -- I am just hesitating to make a
`
`·4· ·blanket statement for every linear stapler.· This
`
`·5· ·particular one, because I've analyzed it
`
`·6· ·carefully, I'm able to say that with some level
`
`·7· ·of -- of confidence; but for any other linear
`
`·8· ·stapler, I would just hesitate to make that
`
`·9· ·blanket statement.
`
`10· · · · Q.· · ·Okay.· So at least in the context of
`
`11· ·an E-beam where the jaws are kind of forced
`
`12· ·closed until it's fully retracted, you're saying
`
`13· ·it's important to have a mechanism to guarantee
`
`14· ·you can retract it?
`
`15· · · · A.· · ·And then maybe -- maybe I'll just
`
`16· ·repeat what I said.
`
`17· · · · · · · ·In the context of an E-beam as used
`
`18· ·in the '749 patent, yes.· Because "E-beam" is a
`
`19· ·term that is being referenced, and it's being
`
`20· ·described in the '749 patent.· And if you give me
`
`21· ·a second, I'll also find an appropriate image to
`
`22· ·describe, you know, and -- to describe that
`
`23· ·E-beam feature.
`
`24· · · · · · · ·It's on Page 9 of my report.· And
`
`25· ·Page 9 of my report refers to Figure 5 and
`
`15
`
`
`
`·1· ·Figure 6.· And in there, on that E-beam, which is
`
`·2· ·component 80, 8-0, has a pin, which is 110, and
`
`·3· ·that engages or mates with a channel in the
`
`·4· ·anvil, which is 114.
`
`·5· · · · · · · ·So for this particular patent,
`
`·6· ·referring to this E-beam, this figure that I'm
`
`·7· ·showing you, it's evidence here that one has to
`
`·8· ·retract the firing element 80 -- adequately
`
`·9· ·retracted in the proximal direction so that the
`
`10· ·pin no longer -- pin 110 is no longer engaged
`
`11· ·with or mating with the channel 114 because, if
`
`12· ·it were, then the anvil would not be able to
`
`13· ·open.
`
`14· · · · · · · ·If there is another patent and
`
`15· ·instrument -- another design that is the exact
`
`16· ·same design feature or design characteristics as
`
`17· ·is shown by Figure 5 and Figure 6, then the same
`
`18· ·argument would extend.
`
`19· · · · · · · ·Again, I don't want to get caught in
`
`20· ·the terminology of "E-beam" because some
`
`21· ·other patent may use the term "E-beam" to refer
`
`22· ·to something else.· I would rather just focus on
`
`23· ·the specific features of the firing element 80,
`
`24· ·as I've already just done.
`
`25· · · · · · · ·And in the context of these design
`
`16
`
`
`
`·1· ·features, I -- I would say that, yes, you cannot
`
`·2· ·open the anvil unless the firing element is fully
`
`·3· ·retracted.
`
`·4· · · · Q.· · ·Okay.· So let's make it concrete, for
`
`·5· ·example.· So let's go to Exhibit 1004, which is
`
`·6· ·what we've been calling Shelton II.
`
`·7· · · · A.· · ·Yes, I'm there.
`
`·8· · · · Q.· · ·And Figure 5 -- okay.· Let's look at
`
`·9· ·Figure 5 and 6 of Shelton II, which is
`
`10· ·Exhibit 1004.
`
`11· · · · · · · ·Would you agree that what you just
`
`12· ·discussed with regard to the '749 patent would
`
`13· ·apply to this same E-beam design shown in
`
`14· ·Figures 5 and 6 of Shelton II?
`
`15· · · · A.· · ·I would agree.
`
`16· · · · Q.· · ·Okay.· And so -- and when you say
`
`17· ·it's important to fully retract -- or excuse me.
`
`18· ·Let me go back to your actual words.
`
`19· · · · · · · ·So, again, Paragraph 24 -- bear with
`
`20· ·me one second.
`
`21· · · · · · · ·(Pause.)
`
`22· ·BY MR. KATZ:
`
`23· · · · Q.· · ·Yeah.· So in Paragraph 1 -- excuse
`
`24· ·me.
`
`25· · · · · · · ·Can you go back to Paragraph 24 of
`
`17
`
`
`
`·1· ·your declaration, which is Exhibit 2019?
`
`·2· · · · A.· · ·I'm there.
`
`·3· · · · Q.· · ·Okay.· And you say a structure such
`
`·4· ·as an E-beam that holds the jaw closed, that
`
`·5· ·mandates an effective mechanism for assuring that
`
`·6· ·the firing member can fully retract after each
`
`·7· ·use so that, in fact, you can always be able to
`
`·8· ·reopen the jaws.
`
`·9· · · · · · · ·Is that correct?
`
`10· · · · A.· · ·That is correct.
`
`11· · · · Q.· · ·Okay.· And doesn't that suggest that
`
`12· ·you always want to have a manual retraction
`
`13· ·mechanism and that you wouldn't want to rely
`
`14· ·exclusively on an automatic retraction mechanism?
`
`15· · · · A.· · ·I'm not sure if it implies that.
`
`16· · · · · · · ·The importance of the ability to
`
`17· ·open -- and that is understood, and that is what
`
`18· ·I've said here -- the importance of the firing
`
`19· ·member to be fully retracted to be able to open
`
`20· ·the jaws -- that is also what I said here.
`
`21· · · · · · · ·But does that suggest that you always
`
`22· ·have to have a manual retraction?· That -- I'm
`
`23· ·not sure if it provides sufficient argument that
`
`24· ·you have to have -- you absolutely have to have a
`
`25· ·manual retraction and -- in a -- in a linear
`
`18
`
`
`
`·1· ·stapler.
`
`·2· · · · Q.· · ·I think you just went silent on your
`
`·3· ·final statement, or maybe it was just a lag in
`
`·4· ·the video.
`
`·5· · · · · · · ·Did you say anything after you said
`
`·6· ·you absolutely have to have a manual retraction
`
`·7· ·in a linear stapler?
`
`·8· · · · A.· · ·I think I was -- yeah, that was the
`
`·9· ·last thing I said.
`
`10· · · · Q.· · ·Okay.· It was just a video -- a video
`
`11· ·glitch, then.
`
`12· · · · · · · ·All right.
`
`13· · · · · · · ·Okay.· So maybe you're kind of
`
`14· ·bothered by the word "always," so let me ask it
`
`15· ·this way:· If you were going to be using a linear
`
`16· ·stapler with an E-beam that had to be fully
`
`17· ·retracted in order to open, would you feel
`
`18· ·comfortable relying solely on an automatic
`
`19· ·retraction mechanism without a manual backup?
`
`20· · · · · · · ·MR. PEPE:· Object to form.
`
`21· · · · · · · ·THE WITNESS:· So perhaps I can -- I
`
`22· · · · understand your question, and maybe I can
`
`23· · · · ask just for a little bit of context.
`
`24· · · · · · · ·Would you ask -- are you asking
`
`25· · · · this question in my trying to put myself
`
`19
`
`
`
`·1· · · · in the shoes of a surgeon as to whether
`
`·2· · · · they would be willing to use an instrument
`
`·3· · · · like that?· Are you asking this question
`
`·4· · · · in the context of, for example, my senior
`
`·5· · · · design engineer, who is -- who's meant to
`
`·6· · · · approve the design of a certain product,
`
`·7· · · · like, you know, someone who is responsible
`
`·8· · · · for -- for the design of a certain
`
`·9· · · · instrument that's going to go into
`
`10· · · · clinical use, or are you asking this in
`
`11· · · · the context of me being a POSITA and what
`
`12· · · · my -- how would I think if I were a
`
`13· · · · POSITA?
`
`14· · · · · · · ·If you can just help provide that
`
`15· · · · context, it will be -- it will be easier
`
`16· · · · for me to answer the question.
`
`17· ·BY MR. KATZ:
`
`18· · · · Q.· · ·Sure.
`
`19· · · · · · · ·First of all, do you view that the
`
`20· ·answer would change depending on the context?
`
`21· · · · A.· · ·I think it might.· It might.
`
`22· · · · Q.· · ·Okay.· When you are looking at
`
`23· ·a patent disclosure from the perspective of a
`
`24· ·person of ordinary skill in the art, does that
`
`25· ·person consider the needs and desires of a
`
`20
`
`
`
`·1· ·surgeon?
`
`·2· · · · A.· · ·Yes.· At least that person has some
`
`·3· ·sense of where the instrument that they are
`
`·4· ·designing will be used and what setting.· And a
`
`·5· ·person of ordinary skill in the art in this case
`
`·6· ·would have to have some experience of designing
`
`·7· ·surgical instruments.
`
`·8· · · · · · · ·And that experience of designing
`
`·9· ·surgical instruments inherently then brings an
`
`10· ·awareness for the engineer as to what the use
`
`11· ·setting is.· So they're generally aware -- not
`
`12· ·entirely -- not entirely, but they're -- they are
`
`13· ·generally aware of certain key things that are
`
`14· ·important in a clinical setting, such as safety
`
`15· ·and reliability, things that are just very
`
`16· ·fundamental to a surgical setting.
`
`17· · · · Q.· · ·Okay.· And so a person of ordinary
`
`18· ·skill in the art considering the usage of a
`
`19· ·linear surgical stapler -- wouldn't you agree --
`
`20· ·as an expert opining on what a person of ordinary
`
`21· ·skill in the art would believe, wouldn't you
`
`22· ·agree that such a person would think it's highly
`
`23· ·desirable to have a manual retraction mechanism
`
`24· ·in a surgical stapler so you don't have a
`
`25· ·condition where an automatic mechanism fails and
`
`21
`
`
`
`·1· ·you can't open the jaws?
`
`·2· · · · · · · ·MR. PEPE:· Object to form.
`
`·3· · · · · · · ·THE WITNESS:· I understand -- I
`
`·4· · · · understand the question.· I would, again,
`
`·5· · · · hesitate from saying it's highly
`
`·6· · · · desirable.
`
`·7· · · · · · · ·The way I would view the situation
`
`·8· · · · from the perspective of a person of
`
`·9· · · · ordinary skill in the art is that if there
`
`10· · · · is a surgical stapler, a linear stapler,
`
`11· · · · endocutter, that has an automatic
`
`12· · · · retraction mechanism, the first thing that
`
`13· · · · a POSITA would -- would -- would be very
`
`14· · · · aware of is that the automatic retraction
`
`15· · · · mechanism has to be highly reliable -- has
`
`16· · · · to be highly reliable, and the chance of
`
`17· · · · failure should be extremely low.
`
`18· · · · · · · ·If there is any chances of failure,
`
`19· · · · then there should be a backup; there
`
`20· · · · should be a Plan B.· And -- and that way,
`
`21· · · · if -- in the -- in the remote circumstance
`
`22· · · · that the automatic retraction mechanism
`
`23· · · · fails, then the surgeon can go to Plan B.
`
`24· · · · · · · ·Now, what can Plan B be?· What are
`
`25· · · · the options for Plan B?· I would say one
`
`22
`
`
`
`·1· · · · option for Plan B would be giving -- or
`
`·2· · · · designing a feature on the instrument that
`
`·3· · · · is based on manual retraction, that when
`
`·4· · · · the surgeon faces the situation, that they
`
`·5· · · · can then start to rely on that manual
`
`·6· · · · retraction.
`
`·7· · · · · · · ·I would say this is one of the
`
`·8· · · · various options that one may consider.
`
`·9· · · · There could be other options that they
`
`10· · · · consider.
`
`11· · · · · · · ·I think a POSITA working with the
`
`12· · · · rest of the team would -- would evaluate
`
`13· · · · the various options in terms of
`
`14· · · · reliability, complexity, cost, ease of use
`
`15· · · · for the surgeon, and so on.
`
`16· · · · · · · ·And I would agree that a manual
`
`17· · · · retraction system would be a valid option
`
`18· · · · for the POSITA to consider as a backup in
`
`19· · · · case the primary retraction mechanism
`
`20· · · · fails.
`
`21· ·BY MR. KATZ:
`
`22· · · · Q.· · ·And if a POSITA was designing a
`
`23· ·linear surgical stapler and wanted only a single
`
`24· ·retraction mechanism -- they didn't want to have
`
`25· ·a backup -- and they were choosing between
`
`23
`
`
`
`·1· ·automatic or manual, given the concerns of having
`
`·2· ·effective retraction, at least in the case of an
`
`·3· ·E-beam linear stapler, would you agree that --
`
`·4· ·that's too long of a question.· I'm going to
`
`·5· ·start over again.· You see where I'm going, but
`
`·6· ·let me rephrase.
`
`·7· · · · · · · ·If -- if a POSITA were designing an
`
`·8· ·E-beam linear surgical stapler and they were
`
`·9· ·designing in a single retraction mechanism and
`
`10· ·they were choosing between automatic and manual,
`
`11· ·wouldn't you agree that, given your concerns that
`
`12· ·you've outlined, a POSITA would choose a manual
`
`13· ·retraction mechanism?
`
`14· · · · · · · ·MR. PEPE:· Object to form.
`
`15· · · · · · · ·THE WITNESS:· I think -- I
`
`16· · · · understand the question.· I understand
`
`17· · · · your question.· And you're saying that
`
`18· · · · they -- that the POSITA was forced to
`
`19· · · · choose between one of the two.
`
`20· · · · · · · ·My sense is that a POSITA would
`
`21· · · · likely consider, you know, a primary means
`
`22· · · · and potentially a backup means to achieve
`
`23· · · · that retraction.· But if they had to
`
`24· · · · choose only one, the POSITA would find a
`
`25· · · · manual to be more reliable than an
`
`24
`
`
`
`·1· · · · automatic one, potentially -- potentially,
`
`·2· · · · yes.
`
`·3· ·BY MR. KATZ:
`
`·4· · · · Q.· · ·Okay.· You know, let's back up for a
`
`·5· ·minute and talk about your experience.
`
`·6· · · · · · · ·You understand that the POSITA,
`
`·7· ·person of ordinary skill in the art, in this case
`
`·8· ·is the person of ordinary skill in the art around
`
`·9· ·2007 or earlier, depending on what date's being
`
`10· ·chosen?
`
`11· · · · A.· · ·Yes.
`
`12· · · · Q.· · ·Okay.· And in 2007 -- in March 2007,
`
`13· ·where were you?· Were you teaching?· Were you
`
`14· ·getting your Ph.D.?· What were you doing in 2007?
`
`15· · · · A.· · ·In 2007, I had joined the University
`
`16· ·of Michigan, and I was an assistant professor at
`
`17· ·the University of Michigan teaching in connection
`
`18· ·with various projects.
`
`19· · · · Q.· · ·Okay.· And you were teaching what?
`
`20· ·What -- what department were you in?
`
`21· · · · A.· · ·I was in mechanical engineering, and
`
`22· ·I was teaching mechanical design, mechatronic
`
`23· ·design, robotic design.
`
`24· · · · Q.· · ·Okay.· And when you -- in 2007, do
`
`25· ·you remember what month you joined the
`
`25
`
`
`
`·1· ·university?· Was it -- would this be in
`
`·2· ·September 2007 for the fall year?
`
`·3· · · · A.· · ·No.· I actually -- so in --
`
`·4· ·informally, I joined in December of 2006.· And
`
`·5· ·formally, as an assistant professor, my
`
`·6· ·appointment started in the beginning of
`
`·7· ·January 2007.
`
`·8· · · · Q.· · ·Okay.· And when did you get your
`
`·9· ·Ph.D.?
`
`10· · · · A.· · ·I defended my Ph.D. in December of
`
`11· ·2003, and I was awarded my degree in May of 2004.
`
`12· · · · Q.· · ·Okay.· And I'm sure this is on your
`
`13· ·CV, but what were you doing between 2004 and when
`
`14· ·you started as an assistant professor in 2006?
`
`15· · · · A.· · ·I was a mechanical engineer at the
`
`16· ·General Electric Company, GE, at their
`
`17· ·Global Research Center, GRC, Global Research
`
`18· ·Center.
`
`19· · · · Q.· · ·Okay.· And am I correct that prior to
`
`20· ·2007, you had not designed a surgical stapler?
`
`21· · · · A.· · ·That is correct.· That is correct.
`
`22· · · · Q.· · ·Okay.· And, in fact, even as of
`
`23· ·today, is it true that you have not designed a
`
`24· ·surgical stapler?
`
`25· · · · A.· · ·That is correct.
`
`26
`
`
`
`·1· · · · Q.· · ·When -- and, certainly, you've done
`
`·2· ·some research into surgical staplers for your
`
`·3· ·work in this and its -- and -- well, companion --
`
`·4· ·I won't use the word "companion case."· Let me
`
`·5· ·ask again.
`
`·6· · · · · · · ·Certainly, you've done research into
`
`·7· ·surgical linear staplers in the course of your
`
`·8· ·work for Ethicon relating to these various IPRs?
`
`·9· · · · A.· · ·That is correct.
`
`10· · · · Q.· · ·Okay.· And I believe that you first
`
`11· ·started working with Ethicon in conjunction with
`
`12· ·IPR proceedings just a few years ago?
`
`13· · · · A.· · ·That is correct.· I first -- again,
`
`14· ·these group of cases related to endocutters and
`
`15· ·staplers.· I first started working with
`
`16· ·Ethicon -- with -- via their external counsel
`
`17· ·sometime in 2017.
`
`18· · · · Q.· · ·Okay.· And before -- have you ever --
`
`19· ·strike that.
`
`20· · · · · · · ·Have you ever done technical
`
`21· ·consulting for Ethicon directly, as opposed to
`
`22· ·being hired as an expert witness by Ethicon's
`
`23· ·outside counsel?
`
`24· · · · A.· · ·No, I haven't done any technical
`
`25· ·consulting work for Ethicon, no.
`
`27
`
`
`
`·1· · · · Q.· · ·Okay.· And before your work with
`
`·2· ·Ethicon's outside counsel in these various IPR
`
`·3· ·proceedings, had you ever done extensive research
`
`·4· ·into surgical linear staplers?
`
`·5· · · · A.· · ·"Extensive" is a tricky word here.
`
`·6· · · · · · · ·Had I looked into surgical staplers?
`
`·7· ·Was I aware of surgical staplers?· Had I seen and
`
`·8· ·handled surgical staplers?· The answer to all of
`
`·9· ·those questions is yes, that I had -- that I'd
`
`10· ·handled surgical staplers; I had -- I've tried --
`
`11· ·not tried but actually used a surgical stapler
`
`12· ·just in a nonclinical setting, in a design and
`
`13· ·manufacturing setting; I was aware of the
`
`14· ·functionality.
`
`15· · · · · · · ·But did I engage in the design of a
`
`16· ·surgical stapler?· The answer is no.
`
`17· · · · Q.· · ·All right.· And when did you first
`
`18· ·use a surgical stapler, to your knowledge?· Do
`
`19· ·you recall when that was?
`
`20· · · · A.· · ·When did I first handle a surgical
`
`21· ·stapler?
`
`22· · · · · · · ·The first I handled a surgical
`
`23· ·stapler would have been in the 2007 time frame,
`
`24· ·where -- even prior to 2007 -- prior to 2007 --
`
`25· ·between 2004 and 2007, I familiarized myself with
`
`28
`
`
`
`·1· ·various surgical instruments that are used in
`
`·2· ·minimally invasive surgery.
`
`·3· · · · · · · ·So I was aware in that period of 2004
`
`·4· ·to 2007.· I was aware of what is a needle holder,
`
`·5· ·what is a shear, what is a grasper, what is a
`
`·6· ·dissector and what is a surgical stapler.
`
`·7· · · · · · · ·During that period, at no point did I
`
`·8· ·start working on the design of any of these; but
`
`·9· ·during that period, I started conceptualizing
`
`10· ·design of, more generically, a surgical
`
`11· ·instrument that would provide articulation
`
`12· ·capability, and that articulation capability
`
`13· ·would apply to any of these instrument types.
`
`14· · · · · · · ·Upon starting at the University of
`
`15· ·Michigan in 2007, via my collaborations in the
`
`16· ·medical school here, I was able to gain access to
`
`17· ·a variety of surgical instruments, including a
`
`18· ·surgical stapler.· That is the first time, in
`
`19· ·2007, that I would have physically seen and
`
`20· ·handled a surgical stapler.
`
`21· · · · · · · ·Over the years -- the first time I
`
`22· ·operated a surgical stapler to actually see
`
`23· ·the -- the -- the staples being fired and the
`
`24· ·staples being formed -- that would have been in
`
`25· ·the 2014 or 2015 time frame.
`
`29
`
`
`
`·1· · · · · · · ·Again, that's sort of the history of
`
`·2· ·when I was aware of these type of instruments,
`
`·3· ·when I first handled them and when I first -- not
`
`·4· ·in a clinical setting; it's more in an industrial
`
`·5· ·setting -- just to -- to operate the device and
`
`·6· ·see the formation of staples.
`
`·7· · · · Q.· · ·Okay.· So the first time that you
`
`·8· ·actually operated a surgical stapler -- again,
`
`·9· ·not in a clinical setting but just in some form
`
`10· ·of a test setting -- was in 2014?
`
`11· · · · A.· · ·The first time I operated it -- and
`
`12·
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