`Fotin-Mleczek, Ph.D., Mariola CONFIDENTIAL
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`October 3, 2018
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` __________________
` BEFORE THE PATENT TRIAL APPEAL BOARD
` __________________
` MODERNATX, INC.,
` Petitioner,
` vs.
` CUREVAC AG,
` Petitioner.
` ___________________
` Case IPR2017-02194
` Patent No. 8,383,340
` ____________________
` CONFIDENTIAL TRANSCRIPT
` DEPOSITION OF
` MARIOLA FOTIN-MLECZEK, Ph.D.
` Washington, D.C.
` Wednesday, October 3, 2018
` 9:06 a.m.
`Job No. 44199
`Reported By: Donna A. Peterson
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`MTX1076
`ModernaTX, Inc. v. CureVac AG
`IPR2017-02194
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`Case IPR2017-02194
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` The Deposition of MARIOLA FOTIN-MLECZEK, Ph.D.,
`taken at the law offices of:
`
` CROWELL & MORING, LLP
` Boardroom, 11th Floor
` 1001 Pennsylvania Avenue, N.W.
` Washington, D.C. 20004-2595
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` Pursuant to Notice, before Donna A.
`Peterson, Notary Public in and for the District of
`Columbia.
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` A P P E A R A N C E S
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` ON BEHALF OF PETITIONERS, MODERNATX, INC.:
` ELDORA LYNN ELLISON, Ph.D., ATTORNEY at LAW
` DAVID W. ROADCAP, Ph.D., ATTORNEY at LAW
` STERNE, KESSLER, GOLDSTEIN & FOX, PLLC
` 1100 New York Avenue, N.W.
` Washington, D.C. 20005
` Telephone: (202) 772-8508
` eellison@skgf.com
` droadcap@sternekessler.com
`
` ON BEHALF OF PATENT OWNER, CUREVAC AG:
` SHANNON LENTZ, ATTORNEY at LAW
` DEBORAH H. YELLIN, ATTORNEY at LAW
` CROWELL & MORING, LLP
` 11th Floor
` 1001 Pennsylvania Avenue, N.W.
` Washington, D.C. 20004-2595
` Telephone: (202) 624-2500
` slentz@crowell.com
` dyellin@crowell.com
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` A P P E A R A N C E S C O N T I N U E D
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` ALSO PRESENT: Dr. Anita Buck, CureVac
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` C O N T E N T S
`EXAMINATION OF MARIOLA FOTIN-MLECZEK, Ph.D. PAGE
` By Ms. Ellison 6
`
` E X H I B I T S
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit MTX 1001 U.S. Patent No. 8,383,340 48
`Exhibit MTX 1004 U.S. Patent No. 6,567,133 50
`Exhibit MTX 1005 Journal article, Rigid polymerics: 50
` the future of oligonucleotide
` analysis and purification,
` Lloyd, et al., Journal of
` Chromatography A, 1009(2003)223-230
`Exhibit CureVac 2012 Declaration Of Mariola 10
` Fotin-Mleczek, Ph.D.
`Exhibit CureVac 2017 Curriculum Vitae, Mariola 76
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` Fotin-Mleczek, Ph.D.
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` P R O C E E D I N G S
`Thereupon,
` MARIOLA FOTIN-MLECZEK, Ph.D.,
`was called as a witness by counsel for Petitioner,
`Moderna Therapeutics, and having been duly sworn by
`the Notary Public, was examined and testified as
`follows:
` MS. ELLISON: Good morning.
` THE WITNESS: Good morning.
` MS. ELLISON: We'll start with a roll call
`today. I'm Eldora Ellison, from Sterne, Kessler,
`Goldstein and Fox, and I representing Moderna
`Therapeutics. And here together with me today is my
`colleague, David Roadcap, who also is from Sterne,
`Kessler.
` MS. LENTZ: I'm Shannon Lentz, from
`Crowell and Moring, on behalf of CureVac. And with
`me today is Debbie Yellin, of from Crowell and
`Morning, and Anita Buck, of CureVac.
` EXAMINATION BY COUNSEL FOR PETITIONER, MODERNA
`BY MS. ELLISON:
` Q. Could you please state your name, for the
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`record.
` A. Mariola Fotin-Mleczek.
` Q. I will try very hard to pronounce your
`last name correctly, but please forgive me if I
`don't, okay?
` A. No problem.
` Q. Thank you.
` Have you ever been deposed before?
` A. (No response.)
` Q. Have you ever had to be a witness in a
`deposition like this before?
` A. No.
` Q. Okay.
` A. I haven't.
` Q. We'll go over some of the ground rules,
`which I imagine your counsel has also explained to
`you.
` A. Uh-huh.
` Q. We'll go over them.
` A. Yes.
` Q. So first, you see there is a court
`reporter who is transcribing what we are both saying,
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`so it is important that you give your answers out
`loud today and it is important that we try not to
`speak over each other today. Okay?
` A. Yes.
` Q. And you understand that you are under oath
`and obligated to tell the truth to the best of your
`ability today?
` A. Yes, I do.
` Q. Okay. Now that this deposition has begun,
`the rules of the Patent Office prevent you from
`speaking to lawyers for CureVac about the case and
`the substance of your deposition during this
`cross-examination.
` Do you agree to abide by that?
` A. Yes.
` Q. And do you understand that my basic job
`today is to ask you questions and your job today is
`to answer my questions?
` A. Yes.
` Q. Your lawyer may object to some of the
`questions that I ask, but unless she instructs you
`not to answer, you have to answer the questions. Do
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`you understand that?
` A. Yes, I understand.
` Q. Okay. And do you agree to abide by that?
` A. Yes.
` Q. Thank you.
` If, at any point today, you would like a
`break, just ask for one. If there's a question
`pending, I may ask that you answer the question
`before we take a break, but, otherwise, I will
`generally try to accommodate any requests for a
`break, okay?
` A. Yes, okay.
` Q. And we'll break approximately every hour.
`I'm sure Ms. Lentz will testify to that, if
`necessary.
` A. That's good.
` Q. Okay.
` If you have any questions about my
`questions, if anything is unclear, please ask me for
`clarification. You cannot ask counsel for CureVac
`for clarification --
` A. Uh-huh.
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` Q. -- but, instead, you have to ask me.
` Do you agree to abide by that?
` A. Yes, I do.
` Q. Is it fair that if you don't ask me for
`clarification, is it fair for me to assume that you
`have understood the questions that I've asked?
` A. Yes.
` Q. Thank you.
` I'm going to hand you a copy of what has
`been marked CureVac Exhibit 2012. I should say my
`associate, David, is going to throw a copy that's
`been marked as Exhibit 2012 to you.
` Do you recognize Exhibit 2012?
` A. Uh-huh -- sorry?
` Q. Do you recognize Exhibit 2012?
` A. 20 --
` Q. The exhibit number is on the lower
`right-hand corner of the first page.
` A. Ah, yeah.
` Yes.
` Q. And what is Exhibit 2012?
` A. I don't know.
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` Q. Is this exhibit a declaration from you?
` A. Yeah. This declaration, yes.
` Q. I'm going to ask you to turn to page 20 of
`Exhibit 2012. Is that your --
` A. Page 20?
` Q. Page 20.
` A. Page or paragraph?
` Q. I'm going to ask you to turn to page 20 of
`Exhibit 2012.
` A. Okay.
` Q. Is that your signature on page 20?
` A. Yes, it's my signature.
` Q. And when did you sign Exhibit 2012?
` A. On the 18th July, 20 -- as of 18.
` Q. In preparing this declaration, did you
`rely upon any documents or information that is not
`disclosed in the declaration?
` A. No.
` Q. In preparing your declaration, did you
`carry out any searches of the scientific literature?
` A. Only what is cited here in the
`declaration.
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` Q. My question is did you carry out any
`literature searches of the scientific literature?
` A. Yes, I did.
` Q. What did you search for in the scientific
`literature?
` A. For the -- I search for the publication,
`yeah, which are relevant, yeah, for preparation of my
`declaration, and this publication are cited here in
`my declaration.
` Q. Can you point me to what you're referring
`to in your declaration.
` A. So I refer to different publications,
`yeah, from Kariko, three from Kariko group, from
`others.
` Q. What database did you search when you
`carried out searches of the scientific literature?
` A. It was PubMed library.
` Q. Any other database?
` A. No.
` Q. And what search terms did you use when you
`searched PubMed?
` A. I rather search by names, yeah, because I
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`knew there are publication regarding this content,
`yeah, and it was rather to find them again as a pdf
`and to read them.
` Q. Which names did you search for when you
`searched PubMed?
` A. Katalin Kariko, Anderson, or RNA messenger
`purification, or PKR activation. Yeah.
` Q. Did you search for all those terms
`together or did you carry out separate searches using
`those search terms you just mentioned?
` A. Separate searches. Altogether, yeah,
`it's --
` Q. I'm sorry, what was your answer?
` A. Sometimes yeah, I used the name and the
`term. And sometimes, yeah, just a term, yeah, for
`example, PKR activation or already on IL-6 yeah.
`Then the term was IL-6, and review after them.
` Q. When you used the search term "mRNA
`purification," did you use that search term alone or
`together with other terms?
` A. Rather alone.
` Q. How many hits did you get when you
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`searched for mRNA purification in PubMed?
` A. I don't remember.
` Q. Can you tell me approximately how many
`hits you obtained?
` A. There were several pages on the hits.
` Q. Would it be fair to say that you obtained
`more than 50 hits when searching PubMed with the term
`"mRNA purification"?
` A. I cannot precise this. I don't remember
`what was --
` Q. Did you review all the hits that you
`obtained when you searched --
` A. No, because I -- as I explained --
` Q. Be sure to let me finish my questions.
` A. Uh-huh.
` Q. Did you review all the hits that you
`obtained when you searched PubMed with the term "mRNA
`purification"?
` A. No, because -- no, I didn't check all of
`them because I looked for the specific papers from
`Katalin Kariko.
` Q. Why did you focus on the papers from
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`Kariko?
` A. Because I knew it was the first paper
`describing the -- it was the paper describing effect
`on HP -- HPLC purification for messenger RNA
`translatability.
` Q. Translatability?
` A. Translatability.
` Q. When you carried out your searches in
`PubMed, were the searches restricted by date?
` A. No.
` Q. Can you identify any other search terms
`that you used when you carried out your searches of
`PubMed?
` A. No. Now I have to -- yeah, as I said, it
`was not the regular big search, but just to get the
`paper I knew from the past, yeah, because I read over
`this paper in the past, yeah, as to just get again
`the pdf's, yeah, to print to look again, yeah.
` Q. Okay.
` A. So the papers I used, yeah, and put in my
`declaration, yeah, were known for me, yeah.
` Q. So is it fair to say that you carried out
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`the PubMed searching to find particular papers that
`you are already aware of?
` A. That are relevant for the declaration and
`for the topic I have to discuss in declaration, yes.
` Q. But you were searching for particular
`papers that you already knew of, correct?
` A. I used the search to find pdf's on this
`paper.
` Q. When did you carry out the searches for --
`of PubMed -- let me try again.
` When did you carry out the searches of
`PubMed?
` A. By preparing this declaration.
` Q. Okay. Did you carry out any searches of
`patents or patent applications in --
` A. No, I --
` Q. -- preparing your declaration?
` A. No, I didn't.
` Q. Let's look briefly at paragraph 11 of your
`declaration. The first sentence of paragraph 11 of
`your declaration refers to reports and papers that
`you read, correct?
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` A. The question is whether it's correct?
` Q. Is it correct that paragraph 11 of your
`declaration refers to reports and papers that you
`read in preparing this declaration?
` A. As I have to say, yeah, that this is not
`exactly correct because I sat together with the
`scientists and inventors but not in the cause to
`prepare this declaration, but in the past. I was
`aware about the data many years before and we discuss
`and sat together, but it's not correct that it's the
`purpose and the cause, yeah, to prepare this
`declaration.
` Q. When did you discover this error in your
`declaration?
` A. When I did this --
` Q. Is it fair to say that there is an error
`in the first sentence of paragraph 11 of your
`declaration?
` A. Yes.
` Q. When did you discover this error?
` A. Yesterday.
` Q. Can you explain to me how this error arose
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`in your declaration?
` A. As I think it was -- I oversaw, yeah, that
`it means direct preparation of this declaration.
`Yeah, to discuss, to prepare, to go, because yeah, I
`discuss, I sat together, I have interaction in the
`past, and the inventors, we discuss this data several
`times, many times at CureVac, yeah. And the mistake
`was, yeah, that here is stated it means, yeah, in the
`purpose and shortly before preparing this
`declaration, I -- yeah. Yeah, this to discuss and
`prepare this declaration, yeah. This -- and prepare
`this prepare this declaration, yeah, this term was
`overseen.
` Q. Overlooked?
` A. Overlooked by me.
` Q. So in paragraph 11, when you say you sat
`together with the scientists and inventors of the
`patent, what time period are you referring to when
`you sat together with the scientists and inventors of
`the patent?
` A. I refer to 2006-7. At the beginning of my
`work with CureVac.
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` Q. When did you join CureVac?
` A. I joined CureVac first May 2006.
` Q. First of May 2006?
` A. First of May.
` Q. And in the first sentence of paragraph 11,
`when you refer to the scientists and inventors of the
`patent, to whom specifically are you referring?
` A. To -- to scientists Jochen Probst.
` Q. Can you spell that, please.
` A. Jochen Probst.
` Q. Can you spell his name?
` A. P-R-O-B-S-T. Was a scientist.
` Q. Okay. And does this first sentence of
`paragraph 11 refer to any other scientist?
` A. No, it was, I think -- Jochen Probst and
`inventors.
` Q. And which inventors?
` A. Thomas Ketterer.
` Q. Any others?
` A. Thorsten Mutzke. Yeah.
` Q. Any others?
` A. Florian Von Der Mulbe.
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` Q. Anyone else?
` A. And Ladislaus Reidel. "Rie-del,"
`"Ree-del." "Rie-del."
` Q. Anyone else?
` A. I don't remember other.
` Q. So is it fair to say that in the first
`sentence of paragraph 11 of your declaration, when
`you say, "I sat together with the scientists and
`inventors of the patent," you're referring to Jochen
`Probst, Dr. Ketterer, Dr. Mutzke, Dr. --
` A. Mutzke is not "Doctor."
` Q. Oh, I'm sorry. I'll ask my question
`again.
` Is it fair to say that in this first
`sentence of paragraph 11 of your declaration, when
`you say, "I sat together with the scientists and
`inventors of the patent," you're referring to Jochen
`Probst, Thomas Ketterer, Florian Von Der Mulbe,
`Ladislaus Reidel --
` A. Uh-huh.
` Q. -- and Thorsten Mutzke?
` A. Yes.
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` Q. Does this first sentence of paragraph 11
`refer to anyone else that I haven't named?
` A. No. I think it's complete.
` Q. Okay. Can you tell me who Jochen Probst
`is?
` A. At this time, Jochen Probst was chief
`scientific officer at CureVac.
` Q. What years was Jochen Probst chief
`scientific officer at CureVac?
` A. Several? Could you repeat the question?
` Q. For what years was Jochen Probst the chief
`scientific officer at CureVac?
` A. For how long?
` Q. What years?
` A. I don't remember correctly, but I think,
`yeah, he was appointed in 2005, so he hired me. And
`then he left the company -- I cannot remember the
`year.
` Q. Do you -- can you recall the year when
`Jochen Probst ceased being chief scientific officer
`at CureVac?
` A. As I said, he was appointed, yeah, before
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`I joined the company. I don't know exactly and a
`date.
` Q. You're currently the chief scientific
`officer at CureVac, correct?
` A. Yes.
` Q. And you've held this position since 2013,
`correct?
` A. Yes.
` Q. Who was chief scientific officer at
`CureVac immediately before you became chief
`scientific officer?
` A. Karl Josef Kallen.
` Q. Can you spell that, please?
` A. Karl, K-A-R-L, Josef Kallen, K-A-L-L-E-N.
` Q. Can you tell me whether -- strike that.
` Do you know whether anyone was chief
`scientific officer after Jochen Probst but before
`Karl Josef Kallen?
` A. Karl Josef Kallen took the position from
`Jochen Probst. It was no further scientific officers
`between me and Jochen.
` Q. Okay. In paragraph -- in the first
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`sentence of paragraph 11 of your declaration, it
`refers to reports and papers.
` Which reports and papers are you referring
`to in paragraph 11 of your declaration?
` A. The paper I cited in this declaration,
`original article describing HPLC purification, impact
`of chemical modification on reduction of immune
`stimulation, but also review article on IL-6 and PKR
`activation.
` Q. Which reports are you referring to in
`paragraph 11 of your declaration?
` A. I refer to the publication of Katalin
`Kariko, two publication. The third one of Anderson,
`also in the contribution of Katalin Kariko. Then
`Nallagatta. I have to be sure that the name are
`correct. The publication of Guillot. All of them
`are cited in my declaration.
` Q. In paragraph 11 --
` A. Tanaka, uh-huh.
` Q. I'm sorry, please finish your answer.
` A. The review from Tanaka, will be sixth
`publication. Shimabukuro-Vornhagen, review.
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` Q. What was that name again from Harvard
`review?
` A. The name of this one --
`Shimabukuro-Vornhagen, yeah.
` Q. Oh, I see.
` A. Yeah.
` Q. S-H-I-M-A-B-U-K-U-R-O dash
`V-O-R-N-H-A-G-E-N, is that correct?
` A. Yes.
` Q. Did you say that was from Harvard review
`or did I misunderstand you? I think I misunderstood
`you.
` A. Sorry?
` Q. You're referring to a publication from the
`Journal of Immunotherapy of Cancer.
` A. Immunotherapy of Cancer. Yeah.
` Q. Not from Harvard review, correct?
` A. Yeah.
` Q. In paragraph 11, what's the difference
`between a report and a paper?
` A. Hmm. As I think there is no considering
`to get -- yeah, to define the difference what I meant
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`is original article showing data and paper reviewing,
`yeah, the field.
` Q. Does -- in paragraph 11, when you refer to
`reports and papers, are you referring to any
`documents other than the scientific publications that
`are identified in your declaration, elsewhere in your
`declaration?
` A. We report --
` Q. I'm sorry, I'll ask the question again in
`a more clear way.
` In paragraph 11, when you refer to
`"reports and papers," are you referring to anything
`other than the published scientific papers that are
`mentioned throughout your declaration?
` A. What this does is included here is the
`Declaration of Moritz Thran because I also read his
`declaration and commented on data, yeah, he provided
`in his declaration.
` Q. Okay. When did you read the declaration
`of Moritz Thran?
` A. Prepare -- before I prepare, as I am
`preparing my declaration.
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` Q. So in paragraph 11, when you say, "I sat
`together with the scientists and inventors of the
`patent" --
` A. Uh-huh.
` Q. When did you sit together with the
`scientists and inventors of the patent, as you
`referred to it in paragraph 11?
` A. It is what I disclose earlier that it is
`some mistake. This discussion of this data and with
`the scientists, yeah, took place, yeah, years before,
`I discuss the data with the inventors, with Jochen
`Probst, yeah, the discussion. Not to prepare this
`declaration. To prepare this declaration, I just
`read the declaration of -- of Moritz Thran, but I
`didn't discuss this with him.
` Q. Okay. Let's look at the next sentence.
`Let's look at the next sentence in paragraph 11. You
`say, "Our internal network of scientists and patent
`managers work closely together to support this
`declaration."
` Do you see that sentence?
` A. Yes.
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` Q. Is that sentence correct?
` A. Yes, this is correct.
` Q. Who were the scientists to whom you're
`referring in paragraph 11 in the sentence that reads,
`"Our internal network of scientists and patent
`managers work closely together to support this
`declaration"?
` A. I knew that for the preparation of this
`declaration and the deposition, our patent attorney
`Anita Buck, Markus Conzelmann work together with
`scientists. As for my department, Moritz Thran.
`Also from other department, from production, to
`prepare this declaration.
` Q. You referred to someone by the name of
`Markus, is that correct?
` A. Yeah, Markus Conzelmann.
` Q. Can you spell his last name, please?
` A. C-O -- C-O-N-Z-E-L-L -- no? One "L"
`-- M-A-N -- N-N.
` You know, at CureVac, here we are just per
`two, yeah. I know to the first name, but not the
`last name.
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` Q. Okay. To the extent that you may have
`gotten help with that answer, I'd appreciate it if
`your colleague sitting here would not help you with
`answers.
` THE WITNESS: N-N. At the end, double
`"N."
`BY MS. ELLISON:
` Q. And who is Markus Conzelmann?
` A. He's also patent -- patent attorney at
`CureVac.
` Q. Can you identify for me the scientists to
`whom you refer in paragraph -- paragraph 11 in the
`second sentence, where you say, "Our internal network
`of scientists and patent managers work closely
`together to support this declaration"?
` A. I knew about, yeah, involvement of Moritz
`Thran. He's the scientist in the research
`department, of my department at CureVac. And
`Alexander Schwenger. As I said, last name, yeah,
`from the colleagues and other department, production,
`I'm not sure. Schwenger?
` Q. Does this second sentence of paragraph 11
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`refer to any other scientists?
` A. I am not aware, yeah, about, but I cannot
`exclude, yeah, that also our patent attorney discuss
`with other. I knew that this two scientists were
`involved.
` Q. Did you work with Alex Schwenger to
`support your declaration?
` A. No, I didn't.
` Q. Do you have an understanding of what Alex
`Schwenger's contribution to your declaration was?
` A. (No response.)
` Q. I'll phrase the question differently.
` Can you explain to me in what way Alex
`Schwenger supported your declaration?
` A. As he didn't directly support my
`declaration.
` Q. Well, you have a sentence here that --
` A. Yeah.
` Q. -- says, "Our internal network of
`scientists and patent managers worked closely
`together to support this declaration." When I asked
`you what scientists you're referring to, you
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`mentioned Thran and Schwenger, correct?
` A. Yeah.
` Q. So I'm trying to understand in what way
`did Alex Schwenger support your declaration.
` A. Yeah, maybe I was not precise, yeah,
`because, yeah, sure it's not for my declaration, as I
`know he has a separate declaration and work together.
`For my declaration, it was just Anita Buck and Moritz
`Thran.
` Q. So is this second sentence in paragraph 11
`of your declaration incorrect?
` A. If we now will restrict, yeah, scientist
`to Moritz Thran, to Anita Buck, then it's correct.
`If it's exactly for this, for my declaration.
` Q. And so in the second sentence of
`paragraph 11, when you refer to "patent managers," to
`whom are you referring?
` A. My declaration, it was Anita Buck.
` Q. Have you ever carried out HPLC?
` A. No, I haven't.
` Q. Have you ever carried out nucleic acid
`purification?
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` A. I haven't purified messenger RNA. Only
`what I did is to isolate messenger RNA with the
`standard RNeasy Kit during my study time or Ph.D.
`work.
` Q. And when was that?
` A. It was 1999, 2000, 2001. Sometimes I used
`this method. It was isolation and not purification
`of messenger RNA.
` Q. And during your Ph.D. research, for what
`purpose did you isolate mRNA?
` A. It was -- it was to -- I'm trying to
`recall this, what was the purpose. Was that 18 years
`ago.
` It was exactly, it was in the course of my
`work at the Fraunhofer Institute after my diploma
`thesis, I was first, I think, nine months at this
`institute and we tried to establish -- or I
`established two hybrid system for the protein,
`protein direction, and I isolated messenger RNA to
`generate DNA library.
` No, it was not -- I cannot really remember
`exactly what was the purpose. But it was in this
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