`Robert Stone, Ph.D.
`October 10, 2018 1
`
`
`Page
`
`285
`
`Page 1
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, D.C.
`
`a ee x
`
`Inv. No.
`337-TA-1110
`
`) ) )
`
`)
`
`) )
`
`) )
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS,
`AND COMPONENTS THEREOF,
`INCLUDING GENERATORS
`
`wime ae aa x
`
`CONTINUED
`
`VIDEOTAPED DEPOSITION
`
`OF ROBERT THOMAS STONE, PH.D.
`
`
`CONFIDENTIAL BUSINESS INFORMATION
`
`SUBJECT TO PROTECTIVE ORDER
`
`Washington, D.C.
`
`Wednesday, October 10, 2018
`
`
`
`Pages:
`
`285 - 508
`
`Reported by: Cindy L. Sebo, RMR, CRR, RPR, CSR,
`
`CRR, CLR, RSA, LiveDeposition Authorized Reporter
`
`247457
`
`Job Number:
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`Bracco Ex. 2005
`Jubilant v. Bracco
`
`IPR2018-01449
`
`10
`
`Ld
`
`12
`
`13
`
`14
`
`15
`
`16
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`17
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`18
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`19
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`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Bracco Ex. 2005
`Jubilant v. Bracco
`IPR2018-01449
`
`
`
`
`
`
`APPEARANCES (Continued):
`
`FOR THE OFFICE OF UNFAIR IMPORT INVESTIGATIONS:
`
`BRIAN KOO, ESQUIRE
`
`OFFICE OF UNFAIR IMPORT INVESTIGATIONS
`
`U.S.
`
`INTERNATIONAL TRADE COMMISSION
`
`500 E Street, Southwest
`
`Suite 401
`
`Washington, D.C. 20436
`
`202.205.2580
`
`brian. kooSusitc.gov
`
`ALSO PRESENT:
`MARTIN SHERRILL, Videographer
`ELIZABETH CONNERS,
`law clerk, Office of
`Unfair Import Investigations, U.s.
`International Trade Commission
`
`
`
`Page
`
`Page 5
`285
`
`INDEX
`
`WITNESS
`ROBERT THOMAS STONE, PH.D.
`By Ms. Bookbinder
`By Mr, Walker
`
`PAGE NO
`
`297, 453, 501
`493
`
`EXHIBITS
`
`STONE
`DEPOSITION
`EXHIBIT NUMBER
`Number 32
`
`DESCRIPTION
`
`PAGE NO.
`
`1¢
`
`11
`
`12
`ia
`14
`15
`
`16
`i7
`18
`13
`20
`21
`22
`23
`24
`25
`
`10
`
`| a2
`12
`13
`
`lg
`is
`
`aE
`
`inSe18
`Number 33
`
`) 19
`
`20
`
`Number 34 Ls
`
`Pursuant to notice, before Cindy L.
`
`Sebo, Registered Merit Reporter, Certified Real-Time
`Reporter, Registered Professional Reporter,
`Certified Shorthand Reporter, Certified Courr
`Reporter, Certified LiveNote Reporter, Real-Time
`Systems Administrator and a Notary Public in and for
`the District of Columbia.
`
`Page
`
`Page 3
`287
`
`APPEARANCES:
`FOR THE COMPLAINANT BRACCO DIAGNOSTICS INC.:
`
`JULIE P. BOOKBINDER, ESQUIRE
`
`OLENA IEREGA, ESQUIRE
`GREENBERG TRAURIG, LLP
`
`MetLife Building
`200 Park Avenue
`New York, New York 10166
`212.801.3129
`
`bookbinderj@gtlaw.com
`leregao@gtlaw.com
`
`FOR THE RESPONDENTS JUBILANT DRAXIMAGE INC.,
`
`JUBILANT PHARMA LIMITED, and JUBILANT LIFE
`SCIENCES:
`
`T, C¥ WALKER, ESQUIRE
`BAKER & HOSTETLER LLP
`
`Washington Square, Suite 1100
`1050 Connecticut Avenue, Northwest
`
`Page
`
`Page 2
`286
`
`Page
`
`Page 4
`288
`
`October 10, 2018
`5:05 a.m.
`
`Confidential Videotaped Deposition
`o£ ROBERT THOMAS STONE, PH.D. held at
`the law
`offices of:
`
`Greenberg Traurig, LLP
`2101 L Street Northwest
`Suite 1000
`
`Washington, D.C. 20037
`
`10
`a1
`12
`13
`14
`15
`16
`lv
`1a
`19
`20
`21
`22
`
`23
`24
`25
`
`16
`11
`12
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`15
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`1?
`18
`
`20
`21
`
`Washington, D.C. 20036 |RSEeS 259
`est
`202.861.1688
`22
`220
`23
`cwalker@bakerlaw.com
`24
`SRSAesEL 366
`25
`
`
`
`
`
`
`
`Page
`
`Page 8
`292
`
`- --
`EXHIBITS (Continued)
`
`1 23
`
`4
`
`Page
`
`Page 6
`290
`
`EXHIBITS (Continued)
`
`5 6
`
`DESCRIPTION
`
`PAGE NO,
`
`STONE
`DEPOSITION
`EXHIBIT NUMBER
`
`12 3
`
`4-
`
`}
`
`6
`
`STONE
`DEPOSITION
`a Number 35SSSSSeSa)
`
`-
`EXHIBIT NUMBER
`DESCRIPTION
`PAGE NO,
`SaSaar]
`|
`©
`sumber 43 ES
`Eaeneeeae
`[SSSaaSSSsiSeeSe
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`13
`2Seeeray
`as)
`Number 44Diaes
`SSaaeSaneesUIBT]nee
`14
`Seeecael
`15
`Number 37
`Patent Application Publication
`16
`Number US 2015/0226368 Al,
`a
`17
`Bates stamped
`ERTeT|SLeTTCE
`18
`BRACCOITCO0633522 through
`a
`366
`13
`BRACCOLTCO0633547
`SneeeeSenel
`20
`
`aaa
`
`BS
`
`Office Action Response for
`Number 38
`aaSaeee
`21
`18
`
`
`
`
`
`
`Application Number 14/426,208,
`
`19 Number 45 TATST
`22
`aSSSSSeeaeenae
`April 5, 2018, Bates
`23
`abeSai2Reee
`aesReaea
`stamped BRACCOLTCO0633511
`24
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`24
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`383
`
`25
`
`
`
`Page
`
`Page 7
`291
`
`Page
`
`Page 9
`293
`
`EXHIBITS (Continued)
`=
`
`STONE
`DEPOSITION
`EXHIBIT NUMBER
`
`DESCRIPTION
`
`PAGE NO.
`
`2
`3
`4
`5
`
`=
`-
`-
`EXHIBITS (Continued)
`Sai
`te
`
`25
`
`12 3
`
`4
`5
`
`6
`
`STONE
`DEPOSITION
`6
`EXHIBIT NUMBER
`DESCRIPTION
`PAGE NO.
`7 Number 39 eMan
`
`7
`Number 46 ara
`ESeeeS
`SeeeeeSe
`iSaaee
`7SaSaae)448
`LSSSareeaSsree
`10
`CaRTSSee407
`12
`11
`Number 47
`Patent Application
`lication
`12
`Number US 2014/0343418, Bates
`Number 40(SOEReetime
`i3
`stamped JDI-ITC-000188162
`fl
`
`aaee 14 Ehrough JDI-ITC-000188203 443
`
`15
`RUTETHINVS)
`Number 48 EY
`
`
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`
`
`
`
`
`Page
`
`Page 10
`294
`
`=
`EXHIBITS (Continued)
`
`STONE
`DEPOSITION
`EXHIBIT NUMBER
`
`DESCRIPTION
`
`PAGE NO.
`
`i3
`
`3
`
`45
`
`6
`
`
`
`Page 12
`Page
`296
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`(2
`PROCEEDINGS
`3
`-
`-
`7
`4
`|
`5
`Washington, D.C.
`7 Number 50Eiesa
`6
`Wednesday, October 10, 2018; 9:05 a.m.
`SSSSET462
`10
`THE VIDEOGRAPHER: This is the
`videotaped deposition of Robert T. Stone
`in the matter of Certain
`
`7 8
`
`|
`
`9
`10
`
`Number 52 ESE
`
`Strontium-Rubidium Radioisotope Infusion
`i
`Systems, et al.,
`| 12
`in the United States
`
`14
`13
`International Trade Commissions [sic]
`in
`
`TERSSITE]464
`
`lE
`
`15
`
`Nunbex 52 EEE
`
`Washington, D.C.
`14
`This deposition is being held at
`15
`Greenberg, LLP, on October 10th, 2018, at
`| 16
`SHSeaET466
`20
`17
`approximately 9:05 a.m.
`18
`My name is Martin Sherrill, and I
`Number 53SSaeey
`a
`19
`am from U.S. Legal Support.
`The court
`| 20
`reporter today is Cindy Sebo, also from
`21
`U.S. Legal Support.
`22
`(Sotto voce discussion with court
`
`reporter and videographer. }
`23
`THE VIDEOGRAPHER: Okay.
`| 24
`25
`Counsel will now state their
`
`[sichsa2]aeSoSa72
`
`a
`
`i & f
`
`Page
`
`Page 11
`295
`
`Page 13
`Page
`297
`
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`EXHIBITS (Continued)
`= 2
`
`STONE
`DEPOSITION
`EXHIBIT NUMBER
`
`DESCRIPTION
`
`PAGE NO.
`
`Number 54 Saw
`
`2
`3
`
`4
`
`5
`6
`7
`
`appearance for the record.
`MS. BOOKBINDER:
`Julie Bookbinder
`
`from Greenberg Traurig for the
`
`Complainant. With me is Olena Ierega.
`MR. WALKER: Cy Walker,
`BakerHostetler, on behalf of the
`
`1 2 3
`
`4
`5
`
`6
`
`7
`
`id
`ll
`
`12
`13
`
`14
`15
`
`16
`
`of Unfair Import Investigations at the
`U.S. International Trade Commission. And
`
`with me today is Elizabeth Conners, a law
`clerk from our office.
`
`THE VIDEOGRAPHER: You may begin.
`== 5
`
`ROBERT THOMAS STONE, FH.D.,
`
`Number §5
`
`Lemer Pax Web page, Bates
`
`Stamped JDI-ITC-000123196
`
`477
`
`Number 56 EY
`
`il
`
`i 1
`
`3
`
`8
`Respondents.
`9
`MR. KOO: Brian Koo with the Office
`SSTT 475
`10
`
`
`
`
`
`AAEETRE]499
`
`
`17
`after having been previously duly sworn, was
`iy
`18
`examined and testified further as follows:
`18
`19
`mn OF
`20
`== -
`
`{**Exhibits Attached to Original Transcript.)
`
`21
`22
`23
`
`EXAMINATION (RESUMED) BY COUNSEL FOR COMPLAINANTS
`-
`=
`-
`
`BY MS. BOOKBINDER:
`
`13
`20
`21
`22
`23
`24
`All right. Good morning, Dr. Stone.
`0.
`24
`25
`Good mormind.
`A.
`25
`
`
`
`
`Robert Stone,
`
`Ph.D.
`
`- Confidential Business Information Subject to Protective Or
`14 to 17
`October 10, 2018
`
`Page 16
`Page 14
`Page
`300
`Page
`298
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`|
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`2
`3
`4
`
`5
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`8
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`
`15
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`a
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`20
`
`21
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`23
`24
`
`25
`
`
`
`the second day of
`It's October 10th,
`0.
`your deposition in this matter, right?
`A,
`Yes.
`
`Okay. And you remember that your
`Q.
`affirmation from yesterday still applies?
`A.
`Yes.
`
`Okay. Did you discuss your testimony
`Q.
`with anyone since we broke for the day yesterday?
`A.
`No.
`
`During the course of the day
`Q.
`yesterday, did you discuss the substance of your
`
`testimony with counsel?
`
`No.
`
`A.
`
`Or with anyone else?
`Q.
`No.
`A.
`Okay. Yesterday, we discussed your
`Q.
`inspection of the Version 1 and Version 2 systems
`at Jubilant in Canada, right?
`A.
`Yes.
`
`if I'm
`And you had an understanding,
`0.
`that the Version 2 had been used at
`correct,
`least in Canada?
`A,
`Yes.
`
`Q.
`
`All right. Was Version 1 used
`
`|
`
`|
`
`|
`
`|
`|
`
`2
`3
`
`4
`5
`6
`7
`
`8
`9
`10
`ll
`12
`13
`i4
`15
`
`16
`li
`18
`
`19
`20
`21
`22
`23
`
`24
`25,
`
`it was used with human patients?
`A.
`Yes;
`
`Do you know whether images were taken
`Q.
`as a result of those uses?
`A.
`I have not reviewed the details of
`how it was used.
`
`And you have not reviewed any
`Q.
`documentation or testimony or any evidence
`regarding the use of Version 1?
`A,
`I don't recall any such evidence.
`Q.
`Okay. Let's go back to Klein -- I
`think you said that Version 1 was somewhat based
`on the Klein Thesis?
`A.
`Yes.
`
`Q.
`A.
`occurred.
`
`When did the uses of Version 1 occur?
`I do not know the details of when it
`
`Q.
`about 2005;
`A.
`0.
`A,
`
`The Klein Thesis was prepared in
`is that right?
`That's my understanding, yes.
`So it was sometime after 20057
`That's correct.
`
`And then if you recall, yesterday, we
`Q.
`looked at some e-mails indicating that the
`
`Page 15
`Page
`299
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER |
`
`2
`
`3
`4
`
`anywhere?
`
`I am told that it -- that Version 1
`A.
`was used at a few universities --
`
`5
`
`6
`
`7
`8
`
`Q.
`
`A.
`
`Q.
`A.
`
`Who told --
`
`-- and --
`
`-- oh, sorry. Go ahead.
`-- I don't recall if I asked that
`
`
`
`
`
`|
`
`|
`
`Page 17
`Page
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`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`2
`3
`
`4
`5
`6
`7
`
`8
`9
`10
`
`Version 3 development was going on, at least in
`2010?
`
`A,
`Q.
`A.
`dates and --
`
`I'd --
`
`I'll accept that.
`Okay --
`-- have to go back and look at my
`
`-- so the Version 1 and Version 2
`0.
`work and use of those systems occurred likely
`between 2005 and 2010?
`
`9
`10
`ll
`2
`
`13
`
`14
`15
`
`16
`17
`
`counsel -- that question of counsel at Jubilant
`or if it was told to me by the attorneys here.
`Q.
`And that was with reference to
`Version 1 being used at a few universities?
`
`Yes, I -- universities, and I believe
`
`A,
`
`it was used in trials in order to get approvals
`for Version 2.
`
`Were any of those universities or
`Q.
`trials in the United States?
`
`|
`
`
`
`That's a likely statement.
`A.
`ll
`And just to be clear, Version 1
`Q.
`12
`predated Version 2, right?
`13
`A,
`Definitely.
`14
`Q.
`Okay.
`15
`So to retum to your analysis of the
`16
`Klein Thesis with respect to the asserted
`17
`18
`Not to my knowledge.
`A.
`patents, The Klein Thesis does not disclose that
`| 18
`the infusion system is configured for the saline
`| 19
`19
`Has the Version 1 device ever been
`Q.
`tubing line and the eluate tubing line to be
`20
`20
`publicly available in the United States?
`routed through two tubing passageways formed in a
`21
`21
`A.
`Not to my knowledge.
`perimeter surface of the first opening, which we
`22
`22
`Q.
`Do you know how Version 1 was used in
`23
`the universities?
`discussed yesterday was the generator
`23
`24
`A.
`I do not know the details.
`24
`compartment, wherein each of the two tubing
`25
`passageways has a depth configured to prevent
`Q. Okay.25 Is it your understanding that
`
`
`
`
`
`
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`
`
`- Confidential Business Information Subject to Protective Or:-
`
`October 10, 2018
`18 to 21
`Page 18
`Page 20
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`302
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`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER |
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`2
`pinching or crushing of a corresponding tubing
`2
`figure.
`3
`line routed therethrough when a first door is
`3
`4
`closed over the opening.
`4
`5
`Is that correct?
`5
`
`Robert Stone, Ph.D.
`
`[
`
`So I'd like to correct that
`testimony. That's -- the Klein Thesis was the
`source of that information, that there's a
`
`6
`7
`8
`9
`10
`il
`12
`13
`14
`15
`16
`
`17
`18
`19
`
`20
`21
`22
`23
`24
`25
`
`I believe that is correct.
`A,
`And we also talked yesterday about
`Q.
`the cart depicted in the Klein Thesis, and you
`stated that an external shell could have an open
`side, right?
`I did.
`A,
`Okay. But the Klein Thesis does not
`0.
`disclose an exterior shell that extends upwardly
`above the platform and has a front side, a rear
`side,
`two sidewalls connecting the front side to
`the rear side.
`
`Right?
`I -- I'm sorry. Repeat that. That
`A,
`doesn't sound correct.
`
`Q.
`
`Sure.
`So I believe that the Klein Thesis
`does not disclose an exterior shell that extends
`upwardly above the platform and has a front side,
`a rear side,
`two sidewalls that connect the front
`side to the rear side.
`
`
`6
`7
`8
`9
`10
`| i1
`12
`3
`14
`15
`16
`
`17
`| 18
`| 19
`
`20
`21
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`| 23
`24
`25
`
`generator access lid on the top of the Klein
`cart --
`Okay --
`Q.
`-- so if we can go to --
`A.
`-- so I want to -- yeah, let's go
`Q.
`through this one step at a time.
`So you're on Page 148 of your opening
`
`report --
`AL
`Q.
`A.
`
`That's correct.
`-- Paragraph 327 --
`Yes.
`
`-- An annotated version,
`Q.
`Klein Thesis, Figure 2-4?
`A.
`Yes.
`
`Q.
`
`So we've got this figure.
`Okay.
`And could you make your correction
`
`again of --
`I couldn't remember where I
`Right.
`A.
`had gotten the information that there was a
`generator access lid on the top.
`It is from the
`
`Page 19
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`303
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER |
`2
`A.
`I don't think that's correct --
`
`Page 21
`Page
`305
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`2
`Klein Thesis, not from the Gen 1. And it's from
`
`3
`4
`5
`
`6
`
`7
`8
`3
`10
`il
`12
`
`Okay.
`Q.
`-- the fact that it's an opening does
`AL
`not mean it's not a side. And that opening is
`
`connected via the sidewalls to the back side.
`
`How do sidewalls connect an open side
`
`Q.
`to anything?
`Let's take a look at the Klein Thesis
`A,
`and the pictures.
`I believe I had it on --
`Q.
`‘Yep.
`A,
`on ORT,
`
`|
`
`3
`4
`5
`
`6
`
`7
`8
`9
`10
`| 11
`12
`
`
`
`
`
`his cart, and it shows the generator access lid
`annotated in his thesis.
`0.
`Who placed these annotations here?
`
`I believe that's in his thesis.
`
`A.
`
`So I think it's
`Let's -- okay.
`0.
`Page 24 of the thesis, which.
`.
`.
`Keep going after that one.
`Which exhibit number?
`MR. WALKER: Exhibit 30.
`THE WITNESS: Exhibit 30, all
`
`A.
`
`right.
`
`Sorry. These were
`BY MS, BOOKBINDER:
`Q.
`Yeah,
`
`--
`
`they had to unbind them to scan
`
`them.
`
`A.
`
`There you go.
`
`Okay.
`
`So you've got Exhibit 30,
`Q.
`Klein Thesis, at Page 24,
`And this is where Figure 2-4 comes
`
`the
`
`from?
`
`i
`Q.
`
`Yes.
`Okay.
`
`So in your report, it looks
`
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`I think this particular element
`Q.
`appears at Page 397 to 398, Element i.1.a of the
`"869 patent.
`A,
`
`Understood.
`I'm -- so I'm looking at 327, and I
`noted yesterday
`--
`
`Q.
`
`Sorry to interrupt.
`
`A
`
`The page, 327, or paragraph?
`Sorry. Paragraph 327.
`-- I noted yesterday that I didn't
`have the confirmation from the Klein Thesis that
`
`there was a generator access lid on the top, but
`it's clearly marked from the Klein Thesis in the
`
`
`
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`
`
`2 3 4 5 6 7 8 9
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`highlighting was added to the generator and
`generator access lid --
`A.
`I believe that's correct, yes.
`Q.
`All right. And what is the generator
`access lid label pointing to?
`A.
`It's pointing to a piece of metal
`that -- its edge begins there in front of a --
`the valve in the motor and extends toward the
`front of the cart.
`
`Can you identify the boundaries of
`Q.
`that piece of metal in this picture?
`A.
`Not completely, because the edges are
`darkened out, so it's impossible to see. But, at
`least, Klein felt that there was a generator
`access lid and labeled that in his thesis.
`
`When you inspected the Version 1
`Q.
`system, did you see the generator access lid?
`A.
`I did. And I wanted to make sure
`
`that was there.
`
`I recall asking the question,
`
`sO -- my memory was foggy yesterday, but now I'm
`remembering I'd seen this and I wanted to make
`sure it was there.
`
`Q.
`
`Did you review any materials since
`
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`the deposition ended yesterday, before today,
`refresh your memory about this?
`A,
`I looked at the reports that I had,
`yes --
`0.
`
`You looked at
`
`--
`
`to
`
`A.
`Q.
`that --
`A.
`
`.
`.
`-- and I found in the report.
`So you looked at your opening report
`
`Yes.
`
`Q.
`
`-- we've been discussing?
`Okay. But I believe you testified
`yesterday that when you inspected the Version 1
`system,
`the generator access lid was -- no one
`moved it --
`A,
`
`That's correct.
`
`Q.
`
`-- correct?
`
`
`
`Page 22
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`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER |
`like some of the labels were removed, and red
`
`18
`19
`20
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`23
`
`in this photo, you
`So to confirm,
`believe this label is pointing to a section --
`not the whole top of the cart but a section of
`the cart that is movable?
`A.
`I believe that's correct.
`
`It might be fabricated from the same
`material as the sidewall, but that doesn't mean
`that it is "the sidewall."
`It has a lip, and
`it's now, you know, on the front side.
`Q.
`So it's your opinion that if there's
`Okay. Was there anything else that
`Q.
`a piece of material forming the sidewall that --
`24
`that exists, so not an opening but material,
`like
`you discovered from your review of your reports
`25
`sheet metal or something -- and it folds at all
`last night that needs to be corrected from
`
`
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`Ph.D.
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`October 10, 2018
`22 to 25
`
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`Page 24
`Page
`308
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`yesterday?
`A.
`
`I don't recall.
`
`So returning to the question
`Okay.
`Q.
`of the sidewalls and the front side -- if we
`
`could get back to that, which was Paragraph 973.
`A,
`I'm sorry.
`Paragraph?
`Q.
`Paragraph 973 on Page 397.
`A.
`Okay.
`Q.
`This is Element 1.1.a of the
`
`'B69 patent relating to a specific configuration
`of an exterior shell that has a front side, a
`
`rear side, and two sidewalls connecting the front
`side to the rear side.
`
`I understand your opinion is that the
`Hlein Thesis discloses that element?
`A.
`Yes.
`
`So then my question is, How do
`Okay.
`Q.
`sidewalls connect an open space to anything?
`A.
`There's not just open space -- space
`on that front side;
`there are lips that fold in
`from either side as well as from the top dow
`onto that front side.
`
`So the open space and the those
`
`sidewalls make up the front side, those lips, if
`
`2w
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`owowsHmwmSew&
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`eeeeeSeene.ODFPSOeaInoewwEPSG
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`
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`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
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`wedfFWe&Bh
`BORES
`
`you would.
`sidewalls.
`
`So those are connected by the
`
`So the side -- are the lips that
`Q.
`you're referring to part of the sidewalls?
`A.
`They're folded over just as a
`continuous sheet metal -- piece of sheet metal
`that would fold around could be a front side and
`
`a back side -- could be a part of it. They're
`extensions of the metal, but they're not on the
`side anymore.
`Q.
`How far does the metal need to extend
`from the side to be considered a front side?
`A,
`The front side -- if it folds around
`
`115
`
`It's
`and extends, it's part of the front side.
`not along -- you're -- it might be part of --
`sorry.
`
`
`
`- Confidential Business Information Subject to Protective Or.
`10, 2018
`26 to 29
`October
`
`Page 28
`Page 26
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`312
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`310
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`2
`attention to the construction of the sidewalls.
`3
`I observed it, but
`--
`
`|
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`Q.
`A.
`
`All right.
`-- did not take notes.
`
`And you can tell from this photo that
`Q.
`the sidewalls do bend around;
`they're not simply
`a thick piece of material?
`A.
`Oh,
`they're definitely thin pieces of
`material.
`I was -- I looked inside, saw where
`
`the lip went backwards. And there was a thin
`piece of metal in the sidewall.
`Q.
`So did you pay attention to the
`construction on the sidewalls when you reviewed
`the Version 1 device?
`
`You just asked if I was looking at
`A.
`the inside and whether it -- looking --
`reflecting back,
`I know I looked inside, saw that
`there was an empty space between that spot and,
`there,
`that there was a lip that folded around.
`And whether it was affixed to it with rivets or
`whether it folded around,
`the smooth comer
`
`appears to be folded around.
`Q.
`When you refer to "the smooth
`comer," where in this picture can you see that?
`
` | 13
`
`Robert Stone, Ph.D.
`
`2
`3
`
`by 90 degrees, even 1-millimeter fold, you've now
`created a front side?
`
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`I think that's an exaggerated way of
`A.
`state -- stating it. Those are obviously on the
`front side and connected to the top side, and
`they fold around to the front side, each of those
`lips that I referred to.
`It's
`It's not a miniscule thing.
`there, and it's on the front of the device. And
`call it -- saying it's a front side simply
`because it is -- has -- is a hole is a limitation
`
`that I don't see required.
`Q.
`Okay.
`If the sidewalls did not have
`a lip and the top and the bottom did not have a
`lip,
`then would there be a front side?
`A.
`They would terminate at the front
`
`side.
`
`So the -- in your view, a front side
`Q.
`could be entirely open?
`A,
`Yes.
`
`And the -- so you mentioned that the
`Q.
`sidewalls bend to make a lip and, also,
`that the
`top and bottom bend to make a lip?
`A,
`There's a -- a bottom piece of metal
`
`Page 27
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`25
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`that folds down from the -- the base there
`
`further on the front side, if you look at it
`carefully.
`The -- the bottom folds down or up?
`0.
`That's hard to say.
`I'm not sure if
`A,
`that's a sliding-out shelf or if it's a -- a
`piece that folds down from the frame.
`I would
`have to disassemble it to determine.
`
`But there is a fronting piece of
`metal on the front side at the bottom.
`
`Q.
`
`And that is around the area of where
`
`the printer appears?
`A.
`Yes,
`just forward of the area of the
`printer and the computer.
`Q.
`I want to make sure we're looking at
`the same picture.
`You're on Page 399 or 398, or
`another -- what page are you on?
`A.
`I'm on 399,
`
`0.
`
`399.
`
`Okay. When you reviewed the
`Version 1 device, did you observe the -- the
`construction of the sidewalls?
`
`A.
`
`I did not pay a great deal of
`
`
`
`
`
`Page 29
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`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`2
`A,
`The smooth corner's at -- on the
`
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`|
`
`
`
`It appears to be a smooth comer
`left-hand side.
`that's folded around, and it's a -- a normal
`means of construction.
`
`And you're -- are you referring to
`Q.
`the -- the -- what appears in this photo on
`Page 399 to be the top left corner, so above and
`to the left of what appears to be a keyboard on
`the shelf?
`Is that the smooth corner?
`
`I would say left and extending up to
`A.
`there are folded-over lips on each of
`the top,
`those sides,
`in my opinion.
`Q.
`On all four corners of the -- the
`
`perspective of the cart that we got in this
`photo?
`That's what it appears.
`A,
`Okay.
`Q.
`and regardless, there is material on
`A,
`the front that is connected via sidewalls to the
`back.
`
`
`
`And to be clear, it's your opinion
`Q.
`that that material on the front is a disclosure
`
`of the front side in the patent claims?
`A.
`That material in the front is on the
`
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`| 25
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`
`the edges, where is the boundary of the interior
`space for that mouse?
`A,
`It's sitting in the interior space on
`a shelf that's enclosed within the cart.
`
`And where does the space end if you
`Q.
`were moving in the -- in the front direction --
`if you're moving towards what you say is the
`front side, doesn't an interior space need to
`have a boundary?
`A.
`Why?
`Q.
`What defines an interior space from
`the rest of the atmosphere?
`A.
`It's enclosed by the edges of the --
`of the cart.
`
`So it's your view that the space is
`Q.
`enclosed even though a side is open?
`A.
`I didn't say that.
`I said the space
`is enclosed by the edges of the cart, not that
`the cart is necessarily closed.
`Q.
`Sure, you're right.
`
`I misspoke about
`
`that.
`
`the edges?
`A.
`
`So the interior space is enclosed by
`
`I would call it interior so long as
`
`
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`2
`front side of the cart.
`
`3
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`I believe you testified yesterday,
`0.
`that in your opinion, a cabinet structure
`
`also,
`
`can havé an open side, right?
`A.
`I did
`
`Okay. How do you define the boundary
`Q.
`of the inner space of the cabinet structure that
`you say is disclosed in the Klein Thesis from the
`surrounding area?
`A.
`I would assume that it stops -- no.
`I'm back to making an assumption.
`I would define it as stopping when it
`reaches the boundary of the front side.
`Q.
`How do you define the boundary of the
`front side?
`
`You stop having more material out
`A.
`front -- front.
`
`What if you are in a space where
`Q.
`there is no material, for example, again,
`in this
`Figure 2-3 from the Klein Thesis, the area where
`the -- it locks like a computer mouse is sitting
`on the middle shelf?
`Is that --
`Yes.
`
`A.
`
`Page 31
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`10
`ll
`
`So there is no material in the
`Okay.
`Q.
`front direction in front of the computer mouse on
`the middle shelf, right?
`A,
`That shelf, if you look at it, isa
`pullout shelf.
`It's a shelf; it's not part of
`the exterior portion of the cabinet.
`So I'm not sure that your -- what
`your question is pointing at.
`Q.
`Sure.
`So I'd like to understand -- so this
`
`12
`13
`4
`
`15
`16
`17
`18
`19
`20
`21
`
`same claim element, 1.1.a, that is reproduced on
`Page 397, we were focusing on the first part
`about the sidewalls and such. The element
`
`continues to state, Wherein the platform and the
`exterior shell collectively defined an interior
`space of the cabinet structure.
`So I'd like to understand your
`opinion that this device has an interior space
`and what the boundaries of that interior space
`are in the Klein Thesis.
`
`I would not call it
`it's enclosed by the edges.
`interior at that point if it goes -- extends
`beyond the edges.
`Q.
`And that is your opinion even though
`the edges are exactly what they -- what you said,
`edges.
`
`They do not extend across the
`entirety of the front side;
`they are only edges?
`A.
`That's correct.
`
`Okay. We began to talk yesterday
`Q.
`about the Bracco Manual, which is Exhibit 31.
`
`the
`The -- in your opinion,
`Bracco Manual does not anticipate any of the
`asserted claims, right?
`It does not contain
`every element of any of the asserted claims?
`A.
`I believe that's correct.
`
`Okay. And the CardioGen-82 system
`Q.
`that you expected and photographed also does not
`anticipate any of the asserted claims, right?
`A.
`I -- I believe that is correct.
`
`The boundaries of the interior space
`A,
`22
`Okay. And yesterday, you testified
`Q.
`that it was a case-by-case basis in your report
`are the edges of the front of the -- the cabinet.
`23
`to understand whether you're relying on the
`0.
`And then in the example of the
`24
`location of the mouse, which is not near any of
`25
`CardioGen-82 system that you inspected or the
`
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`Robert Stone,
`34 to 37
` October 10, 2018
`
`Page 36
`Page
`320
`1 CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`Q.
`All right.
`So separate and apart
`from how the FDA may consider all of these things
`in a bundle together with respect to the patent
`analysis, where we need to identify specifically
`each prior art reference that you're relying on,
`you are relying on a combination of the device as
`a physical thing and the manual for your opinion
`that the claims are obvious?
`
`
`
`Page 34
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`
`2 3 4 5 6 7 8 3
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`i 1
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`13
`14
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`Bracco Manual for your obviousness opinion,
`right?
`I believe that we cite the
`A.
`Bracco Manual in all of those instances.
`
`I think, yesterday, we went through
`Q.
`the exercise of tracking back where you cited an
`internal paragraph for CardioGen-82, and it was
`actually a photograph of the system rather than a
`page of the manual.
`I think that is when you said it's
`case by case that we need to check each citation.
`Does that sound right?
`That sounds right
`--
`Okay.
`-- I'd like to do a readback, but
`
`A.
`Q.
`A.
`
`15
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`Again,
`look at my -- if you'd cite
`
`
`that sounds like we used it to verify that what
`was in the manual was accurate.
`
`What do you mean by that?
`Q.
`Well, we looked at the manual to see
`A.
`what was there,
`to see if it was an accurate
`
`description, as well as our photographs, and used
`that as the basis,
`I believe,
`is how I've done
`that.
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`I rely on the CardioGen-82 system as
`A.
`prior art, and I substantiate the things that
`I've done by looking at the manual and
`referencing it to demonstrate that that device
`was prior art.
`that takes us back
`then,
`Q.
`So I think,
`that it just depends
`to the discussion yesterday,
`on what you cite for each element?
`A.
`Let's go element by element and see
`what's there.
`
`So if we go to
`All right.
`Q.
`Paragraph -- on the same page -- 1668.
`And you discuss the CardioGen-82
`Infusion System in that paragraph, right?
`A.
`Yes.
`
`Q.
`
`Okay. But then the next page,
`
`the
`
`figure that's described in Paragraph 1668 is
`actually from the Bracco Manual, right?
`A.
`That's correct.
`
`So can we be sure that your citations
`Q.
`to infusion system are the device and citations
`to the manual are the manual, or are -- do you
`use them interchangeably?
`I -- I just want to be
`sure we understand --
`MR. WALKER:
`
`I think this had been
`
`I think
`I really do.
`asked and answered.
`he said that -- go through, see what he
`cites; that's what he relies on --
`MS. BOOKBINDER: Sure.
`
`Well, I'd like to ask him about
`
`this specific citation at Paragraph 1668.
`MR. WALKER: And he told you.
`I mean, it says it right there,
`right --
`I --
`MS, BOOKBINDER: Well,
`MR, WALKER:
`-- I don't understand
`
`where you're going.
`-- I'd like to
`MS. BOOKBINDER:
`hear it from -- from Dr. Stone to
`understand --
`
`
`
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`womaHmie&bh
`
`some particular instance, I'd be glad to go over
`it with you.
`Q.
`
`So let's turn to Page 605 of
`
`Sure.
`
`your report.
`
`And this is the first page of your
`opinions regarding the asserted claims being
`obvious in view of a CardioGen reference.
`
`In the title of this section, All
`
`Asserted Claims are Rendered Obvious by the
`CardioGen-82 Infusion System, which reference or
`combination of references are you referring to?
`The Bracco Manual,
`the CardioGen device or both?
`
`Infusion system, as defined by the
`A.
`FDA as a product,
`is the device itself, all of
`its accessories and labeling.
`
`So trying to separate to say it's
`just what we looked at is the cart versus the
`label -- those are one and the same, as far as
`
`the FDA is concerned. And they describe the
`entire system.
`
`So it's completely acceptable to use
`either one of those and be, at least with regard
`to one Government agency, discussing the same
`thing.
`
`| 19
`20
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`
`Robert Stone, Ph.D.
`- Confidential Business Information Subject to Protective Or
`October 10, 2018
`38 to 41
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`MR. WALKER: He told you.
`MS. BOOKBINDER:
`-- what his -- his
`
`“
`
`It's asked and
`
`MR. WALKER:
`answered.
`-- evidence is.
`MS. BOOKBINDER:
`THE WITNESS:
`I said I rely on the
`Bracco system, 82, and that I use the
`mamial as illustrations to what's in the
`thing. Because it would be quite
`difficult to take a picture and show all
`of those components at once, whereas the
`mammal and the literature that backed it
`up have been available for quite some
`time.
`
`There's no reason to suspect that
`the manual is inaccurate in portraying
`what was in the device.
`It makes it
`clear.
`BY MS, BOOKBINDER:
`
`What literature are you referring to?
`Q.
`The manual.
`A,
`I think -- you said the -- the manual
`Q.
`and the literature that backs it up.
`I want to
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`you what it is.
`Q.
`All right.
`And then in the last paragraph of
`this element, Therefore, it is my opinion that
`the CardioGen-82 Infusion System teaches the
`subject matter, you do not have an additional
`paragraph like we saw yesterday in your
`discussion of the Klein Thesis of other
`references redundantly teaching something.
`And I don't believe I saw a paragraph
`like that in any of your CardioGen discussion.
`Do you know if that