`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDERCONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
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`CHRISTOPH HUBER 30(B)(1) - 01/29/2016CHRISTOPH HUBER 30(B)(1) - 01/29/2016
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`Page 144
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`·3· · · · ·THE UNITED STATES DISTRICT COURT
`· · · · · · ·FOR THE DISTRICT OF DELAWARE
`·4
`· · · --------------------- )
`·5· · · · · · · · · · · · · )
`· · · ENDOHEART AG,· · · · ·)
`·6· · · · · · · · · · · · · )
`· · · · · · · Plaintiff,· · ) Civil Action No.
`·7· · · · · · · · · · · · · )
`· · · · · · · · · · · · · · )1:14-cv-01473-LPS-CJB
`·8· · · · v.· · · · · · · · )
`· · · · · · · · · · · · · · )
`·9· · EDWARDS LIFESCIENCES· )
`· · · CORPORATION,· · · · · )
`10· · · · · · · · · · · · · )
`· · · · · · · Defendant.· · )
`11· · --------------------- )
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`13· · · · · · · · ·Videotape Deposition of:
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`14· · · · · · · · ·CHRISTOPH H. HUBER, M.D.
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`15· · · · · · · · ·30(b)(1) taken by BWH
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`16· · · · · · · · ·Volume II - Pages 144 to 276
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`17· · · · · · · · ·Date:· January 29, 2016
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`18· · · · · · · · ·Location:· Paul Weiss - New York
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`19· · · · · · · · ·Time:· 8:00 a.m.
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`21· · · · · · · · · · ·* * *
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`22
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`24· · Reporter:
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`25· · Greg DiDonato, CSR, RPR, CM, CP, CRR
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`DTI Court Reporting Solutions - New YorkDTI Court Reporting Solutions - New York
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`ENDOHEART AG, EX. 2016 Page 1
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
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`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDERCONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
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`CHRISTOPH HUBER 30(B)(1) - 01/29/2016CHRISTOPH HUBER 30(B)(1) - 01/29/2016 Pages 145..148
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`·2· · · · · · · P-R-O-C-E-E-D-I-N-G-S
`·3· · · · · · ·THE VIDEOGRAPHER:· Now recording on
`·4· · record.· Today's date is January 29, 2016, the
`·5· · time is 8:11 a.m.· This is the beginning of
`·6· · volume II, file number 4, in the deposition of
`·7· · Dr. Christoph Huber.
`·8· · · · · · ·All counsel present will be noted on
`·9· · the record by the court reporter.
`10· · · · · · ·I'll also remind the witness you're
`11· · still under oath.
`12· · · · · · ·(Exhibit Defendant's 112, Document in
`13· · native format, EHT 15188, marked for
`14· · identification.)
`15· · CONTINUED EXAMINATION BY COUNSEL FOR INTERVENOR
`16· · BY MR. ABRAMS:
`17· · · · ·Q.· Good morning, Dr. Huber.
`18· · · · ·A.· Good morning.
`19· · · · ·Q.· Yesterday we talked about some of the
`20· · procedures you had done while you were a
`21· · clinical surgeon at, your senior clinical
`22· · fellowship at Brigham & Women's Hospital.
`23· · · · · · ·Let me show you a document we'll mark
`24· · as Exhibit 112.· It does not bear a Bates
`25· · number because it is produced in the native
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`·2· · APPEARANCES:
`·3· · FOR THE PLAINTIFF AND THE WITNESS:
`·4· · MARK BLOOMBERG, ESQ.
`· · · Zuber Lawler & Del Duca LLP
`·5· · 420 Lexington Avenue
`· · · Suite 2640
`·6· · New York, NY· ·10170
`· · · mbloomberg@zuberlaw.com
`·7
`·8· · FOR THE DEFENDANT:
`·9· · CATHERINE NYARADY, ESQ.
`· · · WILLIAM O'HARE, ESQ.
`10· · Paul Weiss Rifkind Wharton & Garrison LLP
`· · · 1285 Avenue of the Americas
`11· · New York, NY· 10019
`· · · cnyarady@paulweiss.com
`12· · wohare@paulweiss.com
`13
`14· · FOR THE INTERVENOR:
`15· · HUGH ABRAMS, ESQ.
`· · · Sidley Austin LLP
`16· · One South Dearborn
`· · · Chicago, IL 60603
`17· · habrams@sidley.com
`18
`19· · ALSO PRESENT:
`20· · Keith Newburry, Vice President
`· · · Intellectual Property
`21· · Edwards Lifesciences
`22
`23· · Michael Drenkalo, Videographer
`24· · Petra S. Gehrung, Interpreter
`25
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`·2· · format, but this is found at EHT 15188, and
`·3· · it's a multipage document, and I'll ask if you
`·4· · recognize this document?
`·5· · · · ·A.· I think that's a continuation of the
`·6· · document we looked at yesterday with
`·7· · additional cases on it.
`·8· · · · · · ·(Exhibit Defendant's 111, PREVIOUSLY
`·9· · MARKED, used in the deposition.)
`10· · BY MR. ABRAMS:
`11· · · · ·Q.· So, you're referring to, and I'll
`12· · hand you Exhibit 111, which is the letter
`13· · dated October 29th, 2004 that had a series of
`14· · cases that had been done?
`15· · · · ·A.· I think that's, yeah, I agree on
`16· · that.
`17· · · · ·Q.· So, is what is shown in Exhibit 112,
`18· · is this an accurate summary of the cases that
`19· · you were involved in as a cardiac fellow at
`20· · Brigham & Women's Hospital, at least some of
`21· · the cases you were involved in?
`22· · · · ·A.· This is a list of some of the cases,
`23· · at least some of the cases I was involved with
`24· · at Brigham and Women's Hospital.
`25· · · · ·Q.· And I ask you to look at Exhibit 112.
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`·2· · · · · · · · ·Friday, January 29, 2016
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`·3· · · · · · · · ·8:00 A.M.
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`·4
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`·5· · · · · · Continued Videotape 30(b)(1)
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`·6· · deposition of Christoph Hans Huber, M.D.,
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`·7· · pursuant to Notice, taken by BWH, held at the
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`·8· · law offices of Paul Weiss Rifkind Wharton &
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`·9· · Garrison LLP, 1285 Avenue of the Americas, New
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`10· · York, New York· 10019, before Gregory T.
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`11· · DiDonato of DTI Court Reporting, Certified
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`12· · Realtime Reporter and Notary Public of the
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`13· · State of New York, there being present:
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`ENDOHEART AG, EX. 2016 Page 2
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
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`http://www.yeslaw.net/help
`
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`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDERCONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
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`CHRISTOPH HUBER 30(B)(1) - 01/29/2016CHRISTOPH HUBER 30(B)(1) - 01/29/2016 Pages 241..244
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`·2· · of the old valve.
`·2· · · · ·A.· Yes; you also have the risk of
`·3· · embolic stroke.
`·3· · · · ·Q.· So, as you say in the second
`·4· · paragraph, "As the old valve is left in place,
`·4· · · · ·Q.· But, as you're describing here in the
`·5· · and the new valve simply implanted, after the
`·5· · provisional, you're saying there's a specific
`·6· · diseased valve has been compressed by a
`·6· · potential problem with it when you do this
`·7· · balloon or other mechanical device, there is
`·7· · orthotopic replacement; correct?
`·8· · · · ·A.· Orthotopic is also what is performed
`·8· · first the risk of embolic stroke or embolic
`·9· · surgically.· Orthotopic just means the valve
`·9· · ischemia from valve or vascular wall debris
`10· · is being put there where the old valve was or
`10· · liberated into the blood flow and moved
`11· · still is; that means orthotopic, at the same
`11· · downstream to smaller vessels creating vessel
`12· · place.
`12· · obstruction."
`13· · · · · · ·And so, isn't that saying that
`13· · · · ·Q.· I see.· So, in the pig studies, did
`14· · there's a potential problem if you simply
`14· · you replace, did you put -- in the studies
`15· · replace the old valve with the new valve by
`15· · that are described in CHUV, done in CHUV
`16· · putting one, what did you say, orthotopically,
`16· · regarding the pigs, did you use the
`17· · with the other?
`17· · transapical approach to remove the old valve
`18· · · · ·A.· Yeah, there could be a potential
`18· · and replace it with a new valve in the same
`19· · problem.
`19· · place?
`20· · · · ·A.· In the pig studies that are
`20· · · · ·Q.· Right.· Now, when you did the pig
`21· · described; no.
`21· · studies in CHUV, did you ever remove the
`22· · original valve and replace it with a new
`22· · · · ·Q.· Now, with the, if you will look at
`23· · valve?
`23· · the patent itself, in the patent there's
`24· · · · ·A.· Did I ever remove pig valves?· Yes, I
`24· · described in the claims of the patent a means
`25· · did remove pig valves.
`25· · for preventing bleeding through the access
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`·2· · · · ·Q.· Right.· My question is with regard to
`·3· · the studies that you described when you talked
`·4· · about the transapical approach, and that type
`·5· · of thing, in those studies each of the valves
`·6· · is placed orthotopically; correct?
`·7· · · · ·A.· Yes.
`·8· · · · ·Q.· So, at the time you -- so, when did
`·9· · you come up with this understanding presented
`10· · in this provisional that there is a potential
`11· · problem with the orthotopic replacement and
`12· · that it should be removed, the original valve
`13· · should actually be removed?
`14· · · · ·A.· When I did cardiac surgery at CHUV.
`15· · · · ·Q.· And was that, what prompted you to
`16· · believe that?
`17· · · · ·A.· Well, we had strokes after the
`18· · surgical aortic valve replacement.
`19· · · · ·Q.· In those you were putting one valve
`20· · on top of the other valve orthotopically?
`21· · · · ·A.· No.· In the patients, we removed the
`22· · old valve.
`23· · · · ·Q.· So, in removing the valve, you don't
`24· · have this problem, do you, of high risk of
`25· · embolic stroke?
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`·2· · device.
`·3· · · · · · ·Are you familiar with that language
`·4· · in the patent claim?
`·5· · · · ·A.· Yes, I am.
`·6· · · · ·Q.· Now, as I understand it, that from
`·7· · documents that I've read in the case, that if
`·8· · you look at column 10 of the patent, lines 8
`·9· · through 16, that what is described in column
`10· · 10, lines 8 through 16, are the means for
`11· · preventing bleeding?
`12· · · · ·A.· That's not precise enough.
`13· · · · ·Q.· Okay.
`14· · · · ·A.· Do you want me to -- what line
`15· · exactly?
`16· · · · ·Q.· Why don't you read to yourself
`17· · column 10, lines 8 through 16, and then I'll
`18· · ask you some questions.
`19· · · · ·A.· 8 through 16?
`20· · · · ·Q.· Yes.
`21· · · · ·A.· Starting with "Access device 60"?
`22· · · · ·Q.· Correct.
`23· · · · · · ·(Pause.)
`24· · · · ·A.· Okay.· I read this.
`25· · · · ·Q.· It mentions in, the specification
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`ENDOHEART AG, EX. 2016 Page 3
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
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`http://www.yeslaw.net/help
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDERCONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
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`CHRISTOPH HUBER 30(B)(1) - 01/29/2016CHRISTOPH HUBER 30(B)(1) - 01/29/2016 Pages 245..248
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`·2· · of as many as possible ways of having a
`·2· · mentions at column 10, line 10, it says,
`·3· · hemostatic valve in place of the access
`·3· · "Valve 63 may be mechanically operable as an
`·4· · device.· If I would have known more, I would
`·4· · iris diaphragm, e.g., like the aperture of a
`·5· · have included more.· But that's what I was
`·5· · lens."
`·6· · aware of from a non-medical field related
`·6· · · · · · ·Do you see that?
`·7· · · · ·A.· Yes, I read there now.
`·7· · valve structures from engineering perspective,
`·8· · for example.· So that's what is there.
`·8· · · · ·Q.· Now, is that what's described there,
`·9· · · · · · ·(Exhibit Defendant's 4, PREVIOUSLY
`·9· · the iris diaphragm, was that something that
`10· · MARKED, used in the deposition.)
`10· · you used in the pig studies at CHUV?
`11· · · · ·A.· If I used a valve or a diaphragm as
`11· · BY MR. ABRAMS:
`12· · an isolated entity?
`12· · · · ·Q.· Earlier you were asked some questions
`13· · · · ·Q.· Well, when you did the pig studies,
`13· · about, let me see, your declaration Exhibit 4.
`14· · you had some sort of valve or some sort of way
`14· · · · · · ·Here is a copy.· Here is Exhibit 4.
`15· · · · ·A.· Thank you.
`15· · to prevent bleeding; correct?
`16· · · · ·A.· Bleeding through what?
`16· · · · ·Q.· I would ask you to turn to your
`17· · · · ·Q.· It's my understanding that this
`17· · declaration, if you would.
`18· · access device that goes into the heart,
`18· · · · · · ·Now, attached to the declaration
`19· · there's a means to prevent bleeding that's
`19· · Exhibit 4 is a declaration that you filed in
`20· · described here?
`20· · the patent office, correct, in 2009?
`21· · · · ·A.· That's correct.
`21· · · · ·A.· I'm not sure I filed that in the
`22· · patent office.
`22· · · · ·Q.· And it describes using some kind of
`23· · valve.· What I'm wondering is whether you used
`23· · · · ·Q.· All right.· Well, you signed it in
`24· · the specific valve described here as an, that
`24· · 2009, and it eventually made its way to the
`25· · includes an iris diaphragm, whether that
`25· · patent office; correct?
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`·2· · specific structure was used in the pig
`·3· · studies?
`·4· · · · ·A.· I don't know what the mechanism was
`·5· · in the pig study used device.· It had a
`·6· · hemostatic, as we call, it valve.
`·7· · · · ·Q.· You don't know what it was at that
`·8· · point?
`·9· · · · · · ·THE REPORTER:· I'm sorry.
`10· · · · · · ·"You don't know what it was at that
`11· · point?"
`12· · · · ·Q.· Well, let me ask a different
`13· · question.
`14· · · · · · ·What do you -- do you recall when you
`15· · conceived of this particular structure of the
`16· · valve, meaning, an iris diaphragm type
`17· · structure that's described here at column 10?
`18· · · · ·A.· That iris diaphragm structure is
`19· · something that you could find in this kind of
`20· · devices.
`21· · · · ·Q.· So, you don't recall anything in
`22· · particular about it, you know, that when you
`23· · came up with that particular use of that type
`24· · of structure for this purpose here?
`25· · · · ·A.· The purpose of that was a description
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`·2· · · · ·A.· I agree.
`·3· · · · ·Q.· And you understood that that
`·4· · declaration, which is two pages here, you
`·5· · understand in the paragraph at the end, it
`·6· · says that it was being made under oath, and
`·7· · subject to the penalties of perjury?
`·8· · · · ·A.· What page are you on right now?
`·9· · · · ·Q.· At the very end, where your signature
`10· · is before March 29th, 2009.
`11· · · · · · ·(Pause.)
`12· · · · ·A.· "Willful false statement"... Yes.
`13· · · · ·Q.· So, you understood the importance of
`14· · the declaration being accurate and true?
`15· · · · ·A.· Yes.
`16· · · · ·Q.· And in the declaration, you make some
`17· · statements with regard to in paragraph 5, you
`18· · say, "I conceived the present invention prior
`19· · to April 23rd."
`20· · · · ·A.· Where are you?
`21· · · · ·Q.· Last two pages, paragraph 5 in the
`22· · declaration of the PD --
`23· · · · ·A.· Okay.· Yes.
`24· · · · ·Q.· All right.· And in there, you say, "I
`25· · conceived the present invention prior to
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`ENDOHEART AG, EX. 2016 Page 4
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
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