`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, MD
`Case IPR2014-00395
`
`
`
`Alexander J. Hill
`12/5/2014
`
`Page 5
`PAGE 3
`
`EXHIBITS 3
`
`DESCRIPTION:
`
`Exhibit 2224 Article "Anatomy of the aortic
`root: Implications for valve—sparing
`surgery" by Charitos and Sievers
`Exhibit 2225 Excerpt from book Heart Valves
`From Design to Clinical Implantation
`Exhibit 2226 Excerpts from book The Aortic
`Valve by Mano Thubrikar
`Exhibit 2227 Medtronic Press Release
`
`"Medtronic CoreValve® System Obtains Early
`FDA Approval on Exceptional Clinical
`Performance"
`
`Exhibit 2228 CoreValve US Important Safety
`Information
`
`Exhibit 2229 U.S. Patent No. 8,323,336 of
`Hill, Prosthetic Heart Valve Devices and
`Methods of Valve Replacement
`
`Exhibit 2230 Colored photocopy of photo
`labeled "Aortic Valve"
`
`Exhibit 2231 Colored photocopy of photo
`labeled "Aortic Valve" with cusps and
`annulus also labeled
`
`Exhibit 2232 Printout from University of
`Minnesota website of mitral and aortic
`va lves
`
`EXHIBITS (CONTINUED):
`
`Exhibit 2233 Printout from University of
`Minnesota website of Chordae Tendineae
`Exhibit 2234
`2014 ESC Guidelines on the
`
`diagnosis and treatment of aortic diseases 166
`Exhibit 2235 U.S. Patent No. 7,914,569, of
`
`Nguyen, Heart Valve Prosthesis and Methods
`of Manufacture and Use
`
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`PREVIOUSLY MARKED EXHIBITS REFERRED TO HEREIN:
`
`Exhibit 1001 U.S. Patent No. 6,482,228 Norred
`
`Exhibit 1009 U.S. Patent No. 6,454,799,
`Schreck
`Exhibit 1018 Declaration of Thomas
`
`Vassiliades, Jr., M.D.
`Exhibit 1026 Declaration of Alexander J.
`
`Hill, Ph.D.
`Exhibit 2003 Hand drawn diagram of ascending
`and descending aorta
`Exhibit 2129 Diagram of Schreck device
`Exhibit 2130 Diagram of Schreck device
`Exhibit 2131 Diagram of Schreck device
`Exhibit 2133 Diagram
`Exhibit 2139 Diagram
`2 5 Exhibit 21 4 0 Diagram
`
`148-157, 171
`
`11, 43, 82
`
`95
`177
`178
`180
`188
`195
`1 9 6
`
`EXHIBITS (CONTINUED):
`Exhibit 2141 Diagram
`
`Exhibit 2198 U.S. Patent No. 6,440,164,
`Di!/Iatteo
`Exhibit 2199 U.S. Patent No. 5,957,949,
`Leonhardt
`Exhibit 2213 u.s. Patent No. 4,030,142,
`Wolfe
`
`*'k******'I:'k
`
`131-139
`
`(REPORTER'S NOTE: original exhibits are attached
`to the original transcript.)
`
`ALEXANDER JOHN HILL,
`
`Page 8
`
`duly sworn, was examined and testified as follows:
`EXAMINATION
`
`BY MR. MARCUS:
`
`What's your name?
`Alexander John Hill.
`
`What's your address?
`Work address or home address?
`Let's do home address first.
`4430 - 118th Avenue Northeast in Blaine.
`
`And your work address?
`8200 Coral Sea Street Northeast in Mounds View,
`
`A
`
`Minnesota.
`
`Q
`A
`Minnesota.
`
`IO
`
`#rOIIrOBzOIIzO.'fl
`
`IO
`
`And you're presently employed?
`Yes.
`
`By whom are you employed?
`Medtronic.
`Is that Medtronic, Inc.?
`Medtronic.
`Incorporated. yes.
`What's your position at Medtronic currently?
`I'm a senior research manager.
`And is that in any particular department?
`Yes.
`It's in coronary and Structural Heart.
`And does that —— in Coronary and Structural
`
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`
`Paradigm Reporting & Captioning
`www.paradigmrep0rting.c0m
`
`#82 776
`
`NORRED EXHIBIT 2353 - Page 1
`
`NORRED EXHIBIT 2353 - Page 1
`
`
`
`Alexander J. Hill
`12/5/2014
`
`Page 9
`Heart, is that within any department, or is that a
`stand—alone?
`
`It's within the Cardiac and Vascular Group.
`business unit within that group.
`Okay.
`To whom do you report?
`Cindy clague. C-1-a-g-u-e.
`What is her title?
`Director Research.
`
`And she is within your group?
`She's in the same business unit.
`
`A
`
`0FDUDFDW
`
`F
`
`Do you report to anyone else?
`Okay.
`That's my direct line.
`I have other
`dotted—line relationships with other people. but she's my
`direct supervisor.
`Q
`Okay. And who do you have dotted—line
`relationships with?
`A
`Senior director of Research and Innovation.
`Matt Birdsall. and VP of Research and Innovation.
`Mike Colson.
`
`Q
`A
`
`And do you have people who report to you?
`I do.
`
`And who are they?
`Q
`Jason Quill, Ph.D., Brian Mcflenry, M.S., and
`A
`Mike Bateman. Ph.D.
`
`Q
`
`Can you outline for us just in general terms
`
`your current duties and responsibilities?
`A Without going into too much confidential
`information.
`I am the core team leader of a transcatheter
`
`Page 10
`
`valve project, and I'm also the functional manager for a
`small subset of research and technology which focuses on
`anatomy and device characterization.
`Q
`What sorts of things just generally do you do
`in that position?
`MR. BARUFKA: Objection, ambiguous.
`Go ahead.
`Q
`so in the first role.
`A
`lead the team.
`
`the core team leader.
`
`I
`
`so I provide direction for the overall
`team across all functions in the development of that
`product.
`In the other role.
`I provide work direction and
`career coaching and help develop employees essentially.
`Q
`Do you currently have any role -— hands—on role
`in research and development of the device?
`A
`Yes.
`
`Q
`A
`
`And what's your role in connection with that?
`So I'm -- in terms of the research and
`
`I participate in brainstorming
`development specifically.
`sessions. participate in experiments to study the device
`both on the bench and in other models.
`
`Does your current work involve in any respect
`Q
`the Corevalve product?
`
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`
`Page: 3
`Page 11
`M. BARUFKA: Objection, outside the scope of
`direct, and it's privileged -— potentially
`privileged information, so confidential, privileged
`information.
`
`Q
`A
`Corevalve.
`
`You can answer.
`My current work does not directly involve
`
`Have you ever done any work in connection with
`Q
`that product?
`A
`I have.
`
`Can you give me the years that you did work in
`Q
`connection with that product?
`A
`Let's see.
`2009 to 2013.
`around there.
`
`'12 and-a-half,
`
`'13,
`
`And we'll go over your employment history in a
`Q
`minute, and we can address that in more detail. Before
`we do that, let me hand you a document marked
`Exhibit 1026. You've seen this document prior to today?
`A
`Yes.
`
`This is a declaration that you prepared for
`Q
`this matter?
`A
`Yes.
`
`Q
`page 22,
`bottom?
`
`And if you look at the back page of this,
`there is your signature there on the line at the
`
`A
`
`Yes.
`
`Page 12
`
`You were asked to prepare this by your
`Q
`employer, Medtronic, Inc.?
`A
`Yes.
`
`Describe the manner in which you went about
`Q
`preparing this document.
`M. BARUFKA: Objection, privileged.
`the witness not to answer.
`
`Instruct
`
`Q
`
`Okay. Did you draft this Exhibit 1026?
`M. BARUFKA: Objection, privileged.
`Instruct
`the witness not to answer.
`
`Did you —— are you going to follow your
`Q
`attorney's instruction?
`A
`Yes.
`
`You say here on the last page —— look at the
`Q
`"Conclusion" heading.
`It says, paragraph 72, "I hereby
`declare that all statements made herein of my own
`knowledge are true."
`Do you see that?
`A
`Uh-huh.
`
`Q
`A
`
`That's a yes?
`I see it.
`
`So I want to get a sense of what parts of this
`Q
`are your knowledge. Let's look at the first —— well,
`let's look at paragraph 3.
`Do you see paragraph 3?
`A
`Yes. I do.
`
`800-545-9668
`612-339-0545
`
`Paradigm Reporting & Captioning
`wwwpmmmgmnqwfihgrom
`
`#82 776
`
`NORRED EXHIBIT 2353 - Page 2
`
`NORRED EXHIBIT 2353 - Page 2
`
`
`
`Alexander J. Hill
`12/5/2014
`
`M. BARUFKA: That's fine.
`
`Page: 4
`Page 15
`
`Page 13
`I understand
`It says, "In forming my opinions,
`Q
`that the claims should be interpreted as they would be
`understood by a person of ordinary skill in the art of
`the subject matter of the patents." Did I read that
`sentence correctly?
`A
`Yes. you did.
`Q
`Was that a sentence that you came up with?
`MR. BARUFKA: Objection, privileged.
`Instruct
`the witness not to answer.
`
`Q
`A
`
`And you won't answer that question?
`No.
`
`The second sentence says, "I also understand
`Q
`that claims are ordinarily construed based on the plain
`meaning of the terms used in the claims, and also with
`respect to the specification,
`the patent drawings, and
`the prosecution history." Did I read that correctly?
`A
`Yes.
`
`Q
`
`Is that language that you came up with?
`MR. BARUFKA: Objection, privilege.
`Instruct
`the witness not to answer.
`
`And you're going to follow your attorney's
`Q
`instruction?
`A
`Yes.
`
`Is that information you knew prior to preparing
`Q
`this Exhibit 1026?
`
`Page 14
`MR. BARUFKA: Objection -- I'm just going to
`have a standing objection if that's okay.
`Q
`The second —— well, and you're not going to
`answer that question either?
`A
`No.
`I'm not.
`
`I
`The next sentence says, "In addition,
`Q
`understand that although the specification should be
`consulted to aid in the process of interpreting the
`claims,
`the specific examples disclosed in the
`specification generally do not limit the scope of the
`claims." Did I read that correctly?
`A
`Yes.
`
`Q
`
`Is that language that you came up with?
`MR. BARUFKA: David, are we going to --
`agree that we just have a standing objection
`What do you want me to do? That's fine.
`MR. MARCUS: No. That's fair.
`I
`think you
`need to object just because I think you need to
`make —— we'll need to make a record on this.
`MR.
`That's fine.
`
`BARUFKA: Okay.
`MR. MARCUS:
`I don't want to ask him something
`you would have let him answer --
`MR. BARUFKA: That's fine.
`MR. MARCUS:
`-- and then assume he wouldn't
`
`answer it, so.
`
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`
`M. MARCUS: With respect to that question,
`understand you're instructing him not to answer?
`M. BARUFKA: That's correct.
`
`I
`
`Q
`A
`
`And you won't answer that?
`Correct.
`
`Can you tell me what that sentence means where
`Q
`you say, "In addition,
`I understand that although the
`specification should be consulted to aid the process of
`interpreting the claims,
`the specific examples disclosed
`in the specification generally do not limit the scope of
`the claims." What does that mean?
`
`Just objection, privileged.
`M. BARUFKA:
`Instruct the witness not to answer.
`
`Q
`A
`
`You won't answer what that means?
`No.
`
`Q
`
`Are these your words or your attorney's words?
`MR. BARUFKA: Objection, privileged.
`Instruct
`the witness not to answer.
`
`I also understand that
`You say here, "Finally,
`Q
`claim interpretation may be aided by reference to other
`sources of information, such as dictionaries,
`textbooks,
`and literature or other patents in related fields,
`in
`order to determine the ordinary meanings of terms used in
`the claims." Did I read that correctly?
`
`Page 16
`
`Yes. you did.
`A
`Was that language that you came up with or that
`Q
`your attorney came up with?
`M. BARUFKA: Objection, privileged.
`the witness not to answer.
`
`Instruct
`
`Q
`sentence.
`
`Tell me what you meant by that particular
`
`M. BARUFKA: Objection, privileged.
`the witness not to answer.
`
`Instruct
`
`And you won't answer that?
`Q
`I'm not going to answer.
`A
`With respect to any of the content contained in
`Q
`Exhibit 1026, are you willing to tell me whether this
`content came from you or from your lawyer?
`M. BARUFKA: Objection, privileged.
`the witness not to answer.
`
`Instruct
`
`You say here, focusing still on paragraph 3, "I
`Q
`further understand that for purposes of this inter partes
`review,
`the claims should be given their broadest
`reasonable interpretation when viewed in light of the
`specification."
`Do you see that language?
`A
`Uh-huh.
`
`Q
`A
`
`Q
`
`That's a yes?
`Yes.
`
`Okay. What does that mean?
`
`800-545-9668
`612-339-0545
`
`Paradigm Reporting & Captioning
`wwwpmmmgmnqwflhgxom
`
`#82 776
`
`NORRED EXHIBIT 2353 - Page 3
`
`NORRED EXHIBIT 2353 - Page 3
`
`
`
`Alexander J. Hill
`
`12/5/2014
`Page 17
`Instruct
`
`Page: 5
`Page 19
`guided by the principles set forth in paragraph 3?
`A Well.
`I was to look at the claims and interpret
`them as broadly as possible by one of ordinary skill in
`the art.
`
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`25
`
`You also say in here in paragraph 3 that you
`Q
`may be aided by "dictionaries,
`textbooks, and literature
`or other patents in related fields." That's correct?
`A
`Uh-huh.
`Q
`That language appears here?
`A
`Yeah. it's there. Uh-huh.
`Q
`Can you tell us what, if any, dictionaries,
`textbooks, or literature or other patents you considered
`as you interpreted the claims set forth in the '228
`patent?
`So there's some prior art that's
`Yeah.
`A
`disclosed elsewhere in my declaration that I reviewed. as
`well as other anatomy textbooks and publications as of
`the time of the publication of this patent, so Circa 2000
`and before.
`Q
`We talked about the Corevalve product a bit
`You recall that testimony?
`Yeah.
`
`ago.
`
`A
`
`Q
`there not?
`
`There are patents covering that product, are
`
`MR. BARUFKA: Objection. This is privileged
`
`Page 20
`Instruct the witness not to answer.
`information.
`M. MARCUS: Well, how is it —- patents are
`public, so you can acknowledge --
`M. BARUFKA:
`He has no --
`M. MARCUS:
`—— whether or not --
`MR. BARUFKA:
`He has no basis or foundation
`for --
`M. KERNELL: That's not a proper objection.
`There's no proper objections --
`Q
`Let me try —- do you know whether there are
`patents covering the Corevalve product?
`A
`I don't know for sure if there are patents
`covering the CoreValve product.
`Q
`So then let me —— I'll ask this question, but I
`think I know the answer to it. Did you consider any of
`the patents covering the CoreValve product as you went
`about interpreting the '228 patent?
`A
`No.
`I did not.
`
`You yourself have been issued a couple
`Okay.
`Q
`of patents, have you not?
`A
`I have.
`Q
`Did you consider those patents as you went
`about interpreting the '228 patent?
`A
`I did not.
`Q
`Did you look at —— actually look at any
`
`MR. BARUFKA: Objection, privileged.
`the witness not to answer.
`Q
`And you won't answer that question?
`A
`No.
`
`I understand that
`You say here, "In addition,
`Q
`claims expressed as a ‘means’ for performing a recited
`function should be interpreted as covering the
`corresponding structure material or acts disclosed in the
`specification or equivalents thereof." Did I read that
`correctly?
`A
`Q
`
`Yes.
`What does that mean to you?
`MR. BARUFKA: Objection, privileged.
`the witness not to answer.
`Q
`And you won't answer that question?
`A
`Correct.
`Q
`With respect to the interpretation standards
`set forth in paragraph 3, did you apply those standards
`as you interpreted the claims set forth in the '228
`patent?
`
`Instruct
`
`MR. BARUFKA:
`Yes.
`
`A
`
`You can answer that.
`
`Okay. Describe then where it says, for
`Q
`example, "the specific" -- I'm focusing on paragraph 3
`again.
`It says, "the specific examples disclosed in the
`
`Page 18
`specification generally do not limit the scope of the
`claims." Describe how you applied that particular
`concept in interpreting the claims set forth in the '228
`patent.
`
`It's
`
`MR. BARUFKA: Objection as to form.
`ambiguous.
`If you want to ask a specific
`question ——
`I
`Q
`Yeah. Let me be straightforward with you.
`to understand what you understand by this language
`so I can get a feel for how you interpret these claims.
`Now, you say in this declaration paragraph number 3 that
`"the specific examples disclosed in the specification do
`not limit the scope of the claims."
`Do you see that
`there?
`
`A Q
`
`A
`
`Uh-huh.
`That's a yes?
`I do see that.
`And again, you won't —— can you —— you won't
`Q
`tell me if this is your language or your lawyer's
`language?
`
`MR. BARUFKA: That's -- objection.
`Okay. What I want to know is what you
`Q
`understood that to mean.
`In other words, when you went
`about interpreting the claims in the '228 patent, what
`25 did you have in your head you were supposed to do as
`
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`
`800-545-9668
`612-339-0545
`
`Paradigm Reporting & Captioning
`www.paradigmrep0rting.c0m
`
`#82 776
`
`NORRED EXHIBIT 2353 - Page 4
`
`NORRED EXHIBIT 2353 - Page 4
`
`
`
`Alexander J. Hill
`12/5/2014
`
`Page: 6
`Page 23
`
`Page 21
`dictionaries in interpreting the language in the '228
`patent?
`A
`
`I did not.
`
`No.
`
`Let's go down to the section of your
`Q
`declaration that talks about work experience. Again,
`you're currently employed by Medtronic?
`A
`Yes.
`
`Q
`A
`
`Receive a salary by Medtronic?
`I do.
`
`And you're being -— you're receiving a salary
`Q
`as you sit here today?
`A
`Yes.
`
`Paragraph 11, it says, "In my current role at
`Q
`Medtronic, Inc., as a Senior Research Manager in the
`Cardiac and Vascular Group, Coronary and Structural
`Heart,
`I manage a group that conducts research focused on
`percutaneous, minimally invasive, and surgical heart
`valve replacement and repair including anatomical
`characterization, device research and design,
`image
`guided therapy development, and animal model development
`for testing of novel products."
`I read that correctly?
`A
`Yes, you did.
`Q
`Okay.
`"I also lead technical projects in
`Structural Heart product development."
`I read that
`correctly as well?
`
`A
`
`Yes.
`
`Page 22
`
`Can you tell us what products you're currently
`Q
`involved with?
`A
`It's a transcatheter heart valve.
`
`Does that have a particular name?
`Q
`It does not.
`It's in the research stage.
`A
`It says, "Over the past eight years,
`I have
`Q
`personally designed and tested numerous percutaneous
`heart valves, and have implanted heart valves into both
`live and isolated hearts."
`I read that correctly?
`A
`Yes.
`
`Q
`right?
`A
`
`Now, you do not have a medical degree.
`
`Is that
`
`I do not.
`
`And you have not —— and maybe you have. Let me
`Q
`ask it this way. Have you ever implanted an artificial
`valve in a live human patient?
`A
`I have not.
`
`Q
`patient?
`A
`
`Have you ever implanted a stent in a live human
`
`I have not.
`
`Have you ever rendered care to a live human
`Q
`patient suffering from any cardiac disease?
`A
`I have not.
`
`Q
`
`Have you ever provided care to a live human
`
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`25
`
`patient suffering from aortic stenosis?
`A
`I have not.
`
`Have you ever been involved in the treatment of
`Q
`a patient suffering from aortic stenosis?
`A
`I have not.
`
`Have you ever been involved in the treatment of
`Q
`any patient suffering any disease of the heart?
`A
`No.
`
`Q
`
`I think I asked this, but let me make sure.
`
`Have you ever worked with any doctors who have treated
`or —— strike that.
`
`Let me ask it this way. Have you ever assisted
`any doctors in treating patients suffering from diseases
`of the heart?
`A
`I have not.
`
`think we covered this, and I
`You agree —— I
`Q
`apologize if this is duplicative. But when we were
`talking about the standard for interpreting these claims,
`the claims of the '228 patent, you would agree that it is
`appropriate to look at other patents in this field and
`related fields?
`
`Agree.
`A
`It is appropriate to look at literature,
`Q
`textbooks, and dictionaries that may bear upon the
`interpretation of those claims?
`
`Page 24
`
`I agree.
`A
`You said -— a moment ago you made reference to
`Q
`the broadest reasonable interpretation standard.
`Do you
`recall that?
`A
`I do.
`
`Okay. And what does that mean to you exactly
`Q
`to apply the broadest reasonable interpretation to the
`claims in the patent?
`A
`It means to look at the claims unless the means
`
`for language is used irrespective of the specifications
`and other language within the patent.
`Q
`Okay. When you say unless the means for
`language is used, what do you mean?
`then. as I
`A
`If the means for a language is used.
`understand it, by law you're supposed to be directed to
`the specifications in the patent and drawings.
`Q
`And then when you go to the specifications in
`the patent, you look at the corresponding structural
`material or acts disclosed in the specification?
`A
`Yes, as I understand it.
`
`Yeah. As well as equivalents of those,
`Q
`correct? You look at equivalents,
`too?
`A
`As equivalents, what do you mean by
`equivalents?
`Q Well, you look at both the corresponding
`
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`
`800-545-9668
`612-339-0545
`
`Paradigm Reporting & Captioning
`www.paradigmrep0rting.c0m
`
`#82 776
`
`NORRED EXHIBIT 2353 - Page 5
`
`NORRED EXHIBIT 2353 - Page 5
`
`
`
`Alexander J. Hill
`12/5/2014
`
`Page 25
`structure material or acts disclosed in the specification
`and equivalents of those materials or acts, correct?
`A
`Equivalents not disclosed in the patent?
`Equivalents disclosed in another patent?
`Q
`Yeah.
`I'm sorry.
`I'm reading from your
`If you could look at paragraph 3 again --
`declaration.
`A
`Yeah.
`
`—— the last sentence, it says, "In addition,
`Q
`understand that claims expressed as a 'means' for
`performing a recited function should be interpreted as
`covering the corresponding structure material or acts
`disclosed in the specification." We talked about that
`earlier, correct?
`A
`Uh-huh.
`
`I
`
`And then you say "and equivalents thereof."
`Uh-huh.
`
`That's a yes?
`That's what the declaration says.
`Okay. Well, tell me what you meant by that,
`Q
`what you meant by looking at equivalents thereof.
`A
`Well. as you're interpreting the claims.
`looking at -- let's see. What's the best way to phrase
`this? A particular structure or material is disclosed.
`and there's an equivalent structure that could perform
`the same function. That's what I would interpret an
`
`Page 26
`
`equivalent as.
`Q
`I would like to turn to your background, if I
`could.
`It's set forth in your declaration but in a
`reverse chronological order, and I would like to walk
`through it chronologically if we could.
`You received a
`bachelor's in biology in 1997?
`A
`That is correct. yes.
`Q
`And that was from Gustavus Adolphus College in
`St. Peter, Minnesota?
`A
`That is correct.
`
`And after you got your bachelor's degree, did
`Q
`you immediately enter the master's program, or what did
`you do?
`I took a year off while applying to
`No.
`A
`graduate school.
`Q
`Okay. Did you work in the medical industry
`during that year?
`I volunteered in a hospital.
`A
`I did not.
`Q
`Okay.
`Then you entered a master's program?
`A
`I entered a Ph.D. program at that point.
`Q
`Okay.
`The Ph.D. program you entered, was that
`the University of Minnesota?
`A
`Yes.
`
`Q
`A
`
`And you entered it in 1999?
`1998.
`
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`
`Page: 7
`Page 27
`So for what period of time were
`1998. Okay.
`Q
`you in the Ph.D. program at the University of Minnesota?
`A
`1998 to 2004.
`
`During the course of that program, it says you
`Q
`received a —- is it a master's in biomedical engineering?
`A
`Yes.
`
`Q
`A
`
`And that was in 2000?
`Yes.
`
`And that was —— was that part of the program?
`Q
`In other words,
`in the Ph.D. program, an intermediate
`step is you received a master's degree?
`A
`Yes.
`
`Okay. And you received a minor in mechanical
`Q
`engineering also in 2000?
`A
`As part of that master's degree. yes.
`Q
`Okay. And then you got your Ph.D.
`You alluded
`to this earlier. But your Ph.D. was awarded to you in
`2004 from the University of Minnesota, correct?
`A
`Yes.
`
`And you received also a minor in cellular and
`Q
`integrative physiology?
`A
`Yes.
`
`Now, during that time period, that would be
`Q
`'99 -- excuse me -- '98 through 2004, you also were
`employed someplace?
`
`A
`
`Yes.
`
`Page 28
`
`Where were you employed?
`Q
`So I was employed through the University as a
`A
`graduate assistant and a tech teaching assistant.
`Q
`And what time period were you employed as a
`teaching assistant through the University?
`A
`That would have been 1999 through two
`thousand -- September of 2003.
`Q
`Okay. And you were a graduate teaching
`assistant you said?
`A
`Yes. and a graduate research assistant.
`part of the program.
`Q
`And what areas did you teach in or assist in
`during that time period?
`A
`so the research assistant was in the Visible
`
`It's
`
`Heart Laboratory. which is the primary laboratory that I
`worked in. And the teaching was in human physiology. an
`undergraduate class. and then later into advanced cardiac
`anatomy and physiology.
`Q
`At some point during that time period, did you
`begin work with Medtronic, or was that after you got your
`Ph.D.?
`
`I did begin to work with Medtronic during that
`A
`time period.
`Q
`Do you remember what year you began to work
`
`800-545-9668
`612-339-0545
`
`Paradigm Reporting & Captioning
`wwwpmmmgmnqwfihgxom
`
`#82 776
`
`NORRED EXHIBIT 2353 - Page 6
`
`NORRED EXHIBIT 2353 - Page 6
`
`
`
`Alexander J. Hill
`12/5/2014
`
`Page 29
`
`Page: 8
`Page 31
`I began
`
`When I joined the vascular group,
`A
`working on product development.
`Q
`Okay.
`A
`Early stage research product development.
`Q
`Was that your first introduction to stents and
`stent technology?
`No.
`
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`25
`
`with Medtronic? And you can reference your --
`A
`Yeah.
`I --
`
`just —— I'm
`I
`—— declaration if you want.
`Q
`trying to walk through it chronologically, so it's
`difficult for me to follow along.
`A
`Sorry. Let's see.
`So it was April of 2000 is
`when I started as an intern.
`
`Q
`
`April of 2000 you said?
`Yeah.
`
`And you were an intern?
`Yes.
`
`Was that a paid internship?
`Yes, it was.
`
`And in what particular area were you an intern
`Q
`for Medtronic?
`
`I was in Cardiac Rhythm Hanagement at the time.
`A
`Cardiac Rhythm Management, does that involve
`Q
`pacemakers?
`A
`Yes.
`
`What did you do as an intern for Medtronic in
`Q
`that time period? And just generally.
`A
`I analyzed the mechanics of pacing leads.
`Q
`Those would be leads placed into the heart to
`help regulate heart rhythm?
`A
`Yes.
`
`Page 30
`Through what period of time did you do that?
`That was from 2000 until 2003.
`
`Q
`A
`
`So you were in that same department as
`I see.
`Q
`an intern for Medtronic through that time period?
`A
`Yes.
`
`In 2003, what did you do?
`I began full-time employment.
`So that would be just before you received your
`
`Yes.
`
`Q A
`
`Q
`
`A
`
`And when you began full—term employment for
`Q
`Medtronic, where did you go to work? What department?
`A
`It's called the Physiological Research
`Laboratories.
`
`Q
`A
`
`What did you do there?
`I was a consultant -- an internal consultant on
`
`various animal studies. anatomy and imaging.
`guidance.
`Q
`A
`
`Through what period of time did you do that?
`From 2003 to 2006, January of 2006,
`I believe.
`
`image
`
`In January 2006, what did you do?
`Q
`Then I joined the vascular group at Medtronic.
`A
`Okay. And how did your work change, if at all,
`Q
`when you joined the vascular group at Medtronic?
`
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`25
`
`When was your first introduction to stents and
`Q
`stent technology?
`A
`It would have been while I was at the
`
`University as a research assistant.
`Q
`Do you remember the year?
`A
`I don't.
`
`How were you introduced to stents and stent
`Q
`technology as a research assistant?
`A
`The Visible Heart is an isolated heart
`
`preparation that we use cameras to visualize the internal
`structures while the heart is beating. and we deployed
`stents within the coronary arteries.
`Q
`When you say we deployed stents, did you
`personally deploy the stents?
`Yes, I did.
`It was in a heart model?
`No.
`It was in an actual heart. so --
`
`Okay. Was the actual heart in an actual live
`
`Page 32
`
`human patient?
`A
`It was not in the patient.
`isolated or ex vivo apparatus.
`Q
`So that would be a heart that was excised from
`a patient?
`A
`
`It's called an
`
`Uh-huh.
`
`Q
`A
`
`That's a yes?
`Yes.
`
`And hooked up to some machinery that keeps it
`Q
`functional?
`A
`Yes.
`
`And then in that excised heart, you employed a
`Q
`stent to keep open -— well, why did you employ stents?
`A
`We deployed stents for educational purposes to
`for the first time visualize what a stent looked like
`
`inside of a beating heart with a direct visualization.
`Q
`During that time period, did you work with any
`artificial valve devices?
`A
`Yes.
`
`Which valve devices did you work with?
`Q
`They were mechanical valves primarily.
`A
`Do you remember what year that occurred?
`Q
`I don't recall the exact year, but it would
`A
`have been while I was a —— so from 1999 to 2003.
`in that
`
`time period.
`
`800-545-9668
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`
`Paradigm Reporting & Captioning
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`
`NORRED EXHIBIT 2353 - Page 7
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`NORRED EXHIBIT 2353 - Page 7
`
`
`
`Alexander J. Hill
`
`12/5/2014
`Page 33
`Sometime in that time period. And did you
`Q
`install those devices —— I think I asked you this, but
`let me make sure. Did you install those devices in this
`excised heart?
`A
`I did not install the heart valves.
`Q
`How did you come to work with them then?
`what capacity?
`So the hearts that we received
`A
`Two capacities.
`in the laboratory sometimes from human patients were
`non-viable for transplant and already had a mechanical
`valve or a tissue valve placed. and then we just took
`pictures of it and video of it. And the second,
`I
`assisted a cardiac surgeon as he was implanting one into
`a pig heart to put on the same apparatus to do the same
`visualization.
`Q
`So you assisted the physician implanting an
`artificial valve in a pig heart that was going to be then
`hooked up to this apparatus?
`A
`Yes.
`Q
`Did you engage in that time period in the
`development of the artificial valve?
`A
`I did not.
`
`Page: 9
`Page 35
`So from 2003 —— I believe 2003 is when you
`That's right.
`started full-time there?
`A
`Right.
`Q
`From 2003 through 2006, you were with —— was it
`Rhythm Management?
`A
`I was with the Physiological Research Labs at
`that point.
`Q
`Okay. Physiological Research Labs. And what
`did you do there?
`I'm sorry.
`I don't think I asked that
`question.
`I worked with all
`So I served as a consultant.
`A
`of the business units to conduct their research on their
`devices within -- to satisfy FDA requirements.
`I
`Q
`Did you work on any —— well,
`the answer,
`think, is no to this. But during that period of time,
`did you work with any artificial heart valves?
`A
`I did not during that time period.
`Q
`Did you work with any stent technology at
`Medtronic during that time period?
`A
`No.
`I did not.
`
`Then in 2006, what, if any, valves were you
`Q
`involved with?
`
`I was involved with products designed
`So 2006,
`A
`to treat the mitral valve and the pulmonic valve and the
`aortic valve.
`
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`25
`
`In
`
`When did you begin work on the actual
`Q
`development of an artificial valve?
`A
`That would be in 2006 when I joined Vascular.
`
`Page 34
`Okay. And I'm just trying to catch up on your
`Q
`information here. All right.
`So if I understand your
`testimony then, you were —— as a student at the
`University of Minnesota, you were involved in this
`Visible Heart project ——
`A
`Uh-huh.
`Q
`—— during which you implanted stents in these
`excised hearts?
`A
`Uh-huh.
`Q
`That's a yes?
`A
`Yes.
`
`And also had the work —— as you described, had
`Q
`some work with these mechanical valves implanted in these
`hearts?
`Yes.
`A
`Your first experience with developing a heart
`Q
`valve was in 2006 when you joined Medtronic?
`A
`Yes.
`Q
`And in the 2006 time period —— so now we're at
`Medtron