`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., )
`)
`Petitioner, ) CASE IPR2017-00203
`)
` vs. ) PATENT 6,649,180
`)
`QUALICAPS CO., LTD. )
`)
`Patent Owner. )
`______________________________)
`
`DEPOSITION OF ARTHUR H. KIBBE, PH.D.
`Atlanta, Georgia
`Friday, June 16, 2017
`
`Reported by:
`Judith Leitz Moran, CCR, RPR, RSA
`JOB NO.: 125630
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` ARTHUR H. KIBBE, PH.D.
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` Friday, June 16, 2017
` 10:00 a.m.
`
` Deposition of ARTHUR H. KIBBE, PH.D., held at
`Kilpatrick Townsend & Stockton, LLP, 1100 Peachtree
`Street, N.E., Suite 2800, Atlanta, Georgia 30309,
`before Judith L. Leitz Moran, Registered
`Professional Reporter, and Certified Court Reporter
`for the State of Georgia.
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` ARTHUR H. KIBBE, PH.D.
`A P P E A R A N C E S:
`
` KILPATRICK TOWNSEND & STOCKTON
` Attorneys for Petitoner
` 1100 Peachtree Street N.E.
` Atlanta, Georgia 30309
` BY: DAVID CLAY HOLLOWAY, ESQUIRE
`
` COVINGTON & BURLING
` Attorneys for Patent Owner
` One City Center
` 850 Tenth Street, N.W.
` Washington, DC 20001
` BY: MEGAN KEANE, ESQUIRE
` SCOTT KAMHOLZ, ESQUIRE
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` ARTHUR H. KIBBE, PH.D.
` ARTHUR H. KIBBE, PH.D.,
`being first duly sworn, was examined as follows:
` THE WITNESS: I do.
` EXAMINATION
`BY MS. KEANE:
` Q Good morning, Dr. Kibbe. Could you
`please state and spell your name for the record.
` A Yes, Arthur H. Kibbe. A-R-T-H-U-R, H
`middle initial, K-I-B-B-E.
` Q Okay. And what's your current address?
` A 116 Fox Run Circle, Clarks Summit,
`Pennsylvania, 18411.
` Q How many times have you been deposed
`before?
` A Over 20.
` Q Okay. And how many times have you
`testified at trial?
` A Somewhat less than that, but at least
`more than 12 or 15 times.
` Q Okay. So somewhere between 15 and 20
`times?
` A I don't know, you'd have to look at my
`CV. I list all the cases with whether I'm just
`deposed or whether I spoke at trial.
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` ARTHUR H. KIBBE, PH.D.
` Q Okay. And in all of those times that
`you've been both deposed and testified at trial,
`have there been any -- where you have been -- you
`have testified in a capacity other than serving as
`an expert in a pharmaceutical case?
` A No.
` Q And I take it all of those cases were
`also patent cases?
` A Yes.
` Q Is there any reason that you cannot
`testify truthfully today?
` A No.
` Q Okay. Any illnesses or medications that
`would prevent you from testifying truthfully today?
` A No.
` Q So I know that you're fairly familiar
`with the ground rules for a deposition, but I'll
`just go over a few reminders.
` I'll be asking you questions today and
`you'll endeavor to answer to the best of your
`ability. We should make sure not to talk over each
`other so that the court reporter can get down both
`the full questions and the answers. Does that make
`sense to you?
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` ARTHUR H. KIBBE, PH.D.
` A Yes, it's hard to do, but it makes sense
`to me.
` Q Great.
` And your attorney may object to some of
`the questions, but unless he instructs you not to
`answer, you'll still need to answer the question.
`Understood?
` A Yes.
` Q Okay. If at any point in time you feel
`that you need a break, let me know. I would just
`ask that we not take any breaks while a question is
`pending.
` A Okay.
` Q I'm going to hand you a document that's
`previously been marked in this proceeding as
`Exhibit 111 -- sorry, 1011. Do you recognize the
`document?
` A Yes, I believe so.
` Q Okay. And what is Exhibit 1011?
` A It's my declaration in support of the
`petition.
` Q Okay. And just for our understanding
`today, do you understand that if I refer to the
`'180 patent that that's referring to U.S. Patent
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` ARTHUR H. KIBBE, PH.D.
`No. 6,649,180?
` A That's right, it's the patent at issue.
` Q If you could turn to Page 56 of
`Exhibit 1011. Okay. And is that your signature
`that's there's on Page 56?
` A Yes, it is.
` Q Okay. And you see that it's dated there
`November 4th, 2016?
` A That's right.
` Q Is November 4th, 2016, the date that you
`signed this declaration?
` A Yes.
` Q When were you first contacted about
`working as a declarant on this case?
` A I don't remember the exact date, but it
`was well before that signature date.
` Q Well before November 2016?
` A Yes.
` Q Okay. Was it in the summer of 2016?
` A It's possible. I really don't remember.
` Q Okay. Would it have been more than six
`months before November 2016?
` A It could have been, but again, I don't
`remember exactly when I was contacted.
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` ARTHUR H. KIBBE, PH.D.
` Q Who contacted you about working on that
`case?
` A A lawyer that's, I think, no longer with
`the firm. She's --
` MR. HOLLOWAY: Maternity leave.
` THE WITNESS: Yeah. Okay.
` THE COURT REPORTER: I'm sorry.
` MR. HOLLOWAY: She's on maternity leave.
` THE WITNESS: I thought she transferred
`to Denver then. No?
`BY MS. KEANE:
` Q If we can keep it to your. Recollection.
`So, is it an attorney --
` A Fine. It was another lawyer at this
`firm.
` Q An attorney at Kilpatrick Stockton?
` A Right.
` MR. HOLLOWAY: Kilpatrick Townsend,
`sorry.
` MS. KEANE: I'm sorry, Kilpatrick
`Townsend.
` A Yeah, Stockton is a different...
`BY MS. KEANE:
` Q Yep, understand.
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` ARTHUR H. KIBBE, PH.D.
` MR. HOLLOWAY: That's why people get mad
`if I don't say that.
`BY MS. KEANE:
` Q Do you have a recollection of when she
`first went on leave?
` A No.
` Q And how were you contacted?
` A I really don't remember exactly, but in
`most cases people phone me.
` Q Okay. And do you know how the attorneys
`identified you as an expert to work on this matter?
` A I don't know how they individually
`identified me.
` Q Have you worked with Kilpatrick in the
`past?
` A I don't remember. I might have. Often
`it's word of mouth, you know. I work with a lawyer
`on a different firm and then there's a lawyer at
`this firm, so...
` Q Okay. Have you worked with any of the
`attorneys on this case in a prior case?
` A Not that I remember.
` Q Have you ever served as an expert on
`behalf of Mylan in other cases?
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` ARTHUR H. KIBBE, PH.D.
` A Yes.
` Q Approximately how many cases?
` A I'd have to look at my CV.
` Q And is your engagement for this matter --
`well, let me back up.
` So you understand that the declaration,
`Exhibit 1011, is the declaration that was submitted
`in support of a petition before -- in an IPR
`proceeding?
` A Before the patent office, yes.
` Q Yes, okay.
` And you understand that in addition to
`the IPR proceeding, there is also litigation in
`district court between the parties?
` A I've been told that that is going on,
`yes.
` Q Okay. Have you been engaged solely to
`work on the IPR matter also on the litigation?
` A No, on only this one.
` Q And by "this one," you mean --
` A The IPR, the one we're talking about
`today.
` Q How many hours of your time did you spend
`working on preparing your declaration, Exhibit
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` ARTHUR H. KIBBE, PH.D.
`1011?
` A I don't remember really. I would have to
`go back and look at my billings.
` Q Okay. Is it more than 10 hours?
` A Oh, yeah.
` Q More than 20 hours?
` A Possibly.
` Q Okay. When is the last time that you
`would have reviewed your billings to see how much
`time you spent working on this matter?
` A I haven't. I send a bill and then I get
`a check and then I just ignore it.
` Q When you are deposed in cases having to
`do with declarations and expert reports that you
`submit in litigation in IPR proceedings, are you
`typically asked how much time you spent working on
`the declarations?
` A A lot of people ask me that.
` Q Yeah. And so is it something you think
`about and consider before the depositions take
`place?
` A No.
` Q And how did you go about preparing your
`declaration?
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` ARTHUR H. KIBBE, PH.D.
` A Okay. So the first step is to review the
`patent to see if what I would think of the patent
`as I've read the patent, okay?
` Q Uh-huh.
` A And then we look for prior art that might
`apply to the essence of the patent. And then we
`see how that prior art supports my initial opinion
`of the patent.
` Okay, if you -- this particular patent is
`extremely obvious that they used standard
`excipients to make a product using --
` THE COURT REPORTER: I'm sorry, the
`standard --
` A The standard excipients to make CIP,
`okay? And so we looked for relevant literature
`that applied to that process. And since the patent
`quotes from The Japanese Pharmacopeia we looked at
`The Japanese Pharmacopeia to -- and then we looked
`at publications that detailed how to make capsules
`out of cellulose derivatives.
`BY MS. KEANE:
` Q Okay. When you say "we," who do you mean
`by we?
` A Well, a lot of times the law firm does
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` ARTHUR H. KIBBE, PH.D.
`better searches than I do, so they'll search
`literature for key words and come up with articles
`that they share with me.
` Q Okay. So the law firms will do the
`searching and look for articles and then pass them
`on to you?
` MR. HOLLOWAY: Objection, form.
` A They will do some of that. And then
`there are documents that I have, for instance, the
`Handbook of Pharmaceutical Excipients which I've
`been associated with since the Second Edition. I
`have all the editions so I can go to that. And
`then there are some basic texts on manufacturing
`and formulation that I have already.
`BY MS. KEANE:
` Q And when you say the first step is to
`look at the patent, is that generally the approach
`that you take with all of your matters?
` A Yeah. In order to understand whether or
`not I can give reasonable opinions about the
`matter, I have to read the patent and then I tell
`the lawyer what my opinion of the patent before
`they tell me where they are on -- on the case. And
`if my opinion of the patent and the direction of
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` ARTHUR H. KIBBE, PH.D.
`their client wants to go is incompatible, then I
`don't do it.
` Q And did you do that in this case?
` A Yes. Of course, I review the patent
`first.
` Q Okay. And in how many instances do you
`recall where attorneys have asked you to look at a
`patent and your views have been incompatible with
`the attorney?
` MR. HOLLOWAY: Objection, form.
` A There have been several over the years.
`And after a while, the -- I don't know, the
`individuals who contact me are usually up front,
`there are different approaches that they take.
` One asks questions about the science
`before they even give me the patent to see where I
`would come down on a particular question and if it
`doesn't work out.
` I've had, I'd say, five cases for sure
`that I told them, you know, I can't take that
`position because it's wrong and...
`BY MS. KEANE:
` Q And that would be five cases over the
`course of time since you started working as an
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` ARTHUR H. KIBBE, PH.D.
`expert consultant?
` A Sure.
` Q And how long has it been since you last
`refused to work as an expert on a patent matter?
` A Well, there's the second reason, is that
`if I think there's a conflict of interest, then I
`don't. And so I've turned down cases in the last
`year.
` Q Okay. With -- sorry, go ahead.
` A No, I don't have anything else.
` Q Okay. With respect to the issue of the
`five cases that you referred to -- sorry, let me
`back up.
` Of the five cases where you did not think
`that you could help with the substance of the
`cases, when was the most recent one of those cases
`that you turned down?
` A About two years ago.
` Q And for the -- for example, the last
`matter about two years ago that you turned down, is
`that because you disagreed with the substance or
`you didn't feel qualified to offer an opinion on
`the subject?
` A No, I disagreed with the substance.
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`ARTHUR H. KIBBE, PH.D.
` Q Did you, yourself, perform any literature
`searches with respect to preparing Exhibit 1011?
` A When I first looked at the patent, I
`looked at some of the references I have in my
`office, but I did not do like a Google search or
`something like that.
` Q Okay.
`MR. HOLLOWAY: You might have to talk a
`little louder if you can.
`THE WITNESS: Okay, I'm sorry.
`MS. KEANE: Let's take a minute and let
`the sirens pass.
`BY MS. KEANE:
` Q So with respect to the references that
`you found in your office, you referred previously
`to the Handbook of Pharmaceutical Excipients, was
`that one of the references you found in your office
`with respect to --
` A Yes, it's right on my shelf.
` Q Okay. And what were the other
`references?
` A I don't remember off the top of my head.
`But I have books on -- like, Lachman's How to Make
`a Tablet, and Banker and Rhodes Pharmaceutical
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`ARTHUR H. KIBBE, PH.D.
`Manufacturing, those kinds of things where you go
`to and see if they've got anything.
`And there is a five-volume text on
`pharmaceutical technology that you can go and look
`at background information for different things. So
`I generally look at those to see if there's
`anything that's useful.
` Q And were any of those references ones
`that you considered in forming your opinions that
`are in Exhibit 1011?
` A Well, of course, the handbook, I always
`consider it when I'm talking about the use of
`excipients. Some of the others might have had just
`background information that was useful to keep in
`mind when we reviewed references that were directly
`related to the issue.
`Would it be easier if he asked the
`
`questions?
` Q And with respect to the Handbook of
`Pharmaceutical Excipients, I take it, you have
`multiple editions?
` A Yes.
` Q And with respect to the other -- besides
`the books that were on your shelves with respect to
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` ARTHUR H. KIBBE, PH.D.
`other references that you considered in preparing
`your declaration, were those all provided to you by
`counsel?
` A I think the majority of them were.
` Q Okay. You say the majority. Are you
`aware of any that were?
` A I don't know for sure one way or the
`other. I know that one is the principle reference
`that shows obviousness. Clearly was given to me by
`counsel the Japanese Yamamoto references.
` Q Okay. So sitting here today, you're not
`aware of any references that are cited in your
`declaration other than the Handbook of
`Pharmaceutical Excipients that you identified
`yourself?
` A No, I can't think of anything off the top
`of my head.
` Q And how did you -- actually, let me back
`up.
` Did you actually write your declaration?
` A Yes, I wrote it. I didn't type every
`paragraph because often in a discussion with the
`lawyers I tell them what issues I want to do and
`they begin to compile it in a format that fits the
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` ARTHUR H. KIBBE, PH.D.
`legal requirements for the case. And then I get to
`review it and edit it and change it and rewrite it.
`So it's an iterative process.
` Q Did you actually type the initial draft
`of your declaration?
` A No, I don't think so.
` Q And did you review a draft that was
`provided to you by counsel?
` A Well, yeah, I reviewed several drafts.
` Q And do you know how many drafts you
`reviewed?
` A No, I don't.
` Q Okay. Was it more than one?
` A Well, I think I've already said I
`reviewed several, so at least more than one.
` Q And do you know who prepared the initial
`draft? Which attorney?
` MR. HOLLOWAY: I'm going to object to the
`form. Instruct you not to answer that one.
` A I don't remember which specific attorney.
`It's been a while.
`BY MS. KEANE:
` Q And how many times did you communicate
`with counsel before the declaration was prepared?
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` ARTHUR H. KIBBE, PH.D.
` A I don't know. I can't remember.
`Several.
` Q How did you typically -- how did those
`communications typically take place?
` A Telephone and email.
` Q Okay. Did you ever meet with counsel in
`person?
` A Yes.
` Q Okay. How many times?
` A At least twice down here.
` Q Okay. And do you know when -- when those
`meetings took place?
` A Well before the signing of the
`declaration.
` Q What is -- in your mind, what does well
`before mean? Is that a few weeks?
` A No, in months or more.
` Q And do you recall how long those meetings
`were?
` A Normally one or two days.
` Q One or two full days?
` A One full day, one and a half days, two
`days, depending on how much we wanted to get
`accomplished. One of the most enjoyable ways for
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` ARTHUR H. KIBBE, PH.D.
`me putting this together is to have someone sitting
`there with a projector and we go through paragraph
`by paragraph. And I say, change this, change that,
`and they generate it as I go and then I get a copy
`afterwards to see if I've got all of my changes in
`there.
` Q And did you exchange drafts of the
`declaration with counsel via email?
` A I might have, yeah. That's the easiest
`way to communicate nowadays.
` Q And what is your process to make sure
`that everything that is in your declaration is
`complete and accurate?
` A I read it all before I sign it. And even
`then I miss typos.
` Q And I take it that the opinions that you
`are offering in Exhibit 1011, those are technical
`opinions --
` A Yes.
` Q -- based on the science?
` You're not offering legal opinions?
` A No, I'm not a lawyer. Although, the
`lawyers tend to offer technical opinions when they
`shouldn't.
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` ARTHUR H. KIBBE, PH.D.
` Q Okay. Are there any errors in Exhibit
`1011 that you would -- that you have noticed since
`you signed the declaration that you're aware of?
` A There's a transcription typo error.
` Q Okay. Do you know where that is?
` A It's in here somewhere, but we spelled
`"group" incorrectly in the copy of the patent.
` Q Okay.
` A It's really not a big thing and I didn't
`want to make a big deal out of it.
` Q Okay. So it's a spelling error in the
`word "group"?
` A Yeah, it's a typo.
` Q Okay. And other than that typo, are you
`aware of anything else?
` A Not really, no.
` Q Okay. And are all of your opinion -- all
`of opinions that you have formed with respect to
`this matter contained in Exhibit 1011?
` MR. HOLLOWAY: Objection, form.
` A I have lots of opinions about the patent,
`but the ones that apply to whether the patent was
`obvious are all in here.
`BY MS. KEANE:
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` ARTHUR H. KIBBE, PH.D.
` Q So all of your -- I take it, all of your
`opinions with respect to obviousness of the '180
`patent are contained in Exhibit 1011?
` A Yes.
` MR. HOLLOWAY: Objection, form.
`BY MS. KEANE:
` Q If you'd take a look at Paragraph 5 of
`your declaration. Other than the documents that
`are referenced in Paragraph 5, is there anything
`else that you relied on in drafting your
`declaration?
` A Well, just my own personal experience and
`knowledge in the area.
` Q But no other documents or materials other
`than what's identified in Paragraph 5?
` A No.
` Q Did you review the petition that was
`filed in this proceeding?
` A Whose petition?
` Q The Petitioner's petition, Mylan's
`petition.
` A Oh, yes, I reviewed it.
` Q Okay. When did you review it?
` A I don't remember exactly. Clearly before
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` ARTHUR H. KIBBE, PH.D.
`it was submitted.
` Q Did you review it before November 4th,
`2016, which is the date that you signed your
`declaration?
` A I don't remember.
` Q How many times did you review the
`petition?
` A Two or three just to make sure that they
`were -- their positions were the same as the ones I
`wanted to take in my declaration.
` Q Did you provide comments on the petition?
` A I think I might have.
` Q Do you know if those comments were
`implemented?
` A I don't -- well, I don't remember. I
`expect that they should have been because that's
`why they hired me, right?
` Q And so I take it then that if you
`reviewed the petition two or three times you
`reviewed drafts of the petition?
` A Well, since I reviewed it two or three
`times, then the first couple must have been drafts
`because you don't review the same thing three times
`in a row, right? So that's pretty obvious.
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` ARTHUR H. KIBBE, PH.D.
` Q Right. Okay. So then I take it that you
`also reviewed that prior to November 4th, 2016,
`which is the date you signed your declaration if
`there were multiple drafts that you reviewed?
` A That's an assumption you're making and
`I'm not sure when I reviewed it. And all I know is
`that I reviewed it before they submitted it.
` Q Okay. Did you review two to three drafts
`of the petition in the same day?
` A That's an interesting question. So often
`I get it and then I'm -- I'm a early riser. So
`I'll work from, say, 5:30 to 6 in the morning till
`9 and send off an email. And if the lawyers make
`the changes and send it back to me and say just to
`verify we made these changes that you suggested, I
`might have seen it twice and just agreed to it.
` Q Okay. In this case, did you see it
`multiple times in the same day?
` A I don't know. I don't remember.
` Q Okay. Did you have a copy of the
`petition while you were working on making changes
`and edits to your declaration?
` A I don't think so.
` Q And what is your understanding with
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` ARTHUR H. KIBBE, PH.D.
`respect to the legal standard of obviousness?
` A I'm not a lawyer. I don't have a legal
`understanding. If there is a legal understanding
`in my declaration, it was explained to me by the
`lawyers and I accept that.
` Q So in your declaration, I take it, you
`offered technical opinions but you didn't undertake
`to apply the legal standard of obviousness to your
`technical opinions?
` MR. HOLLOWAY: Objection to form.
` A Well, I do -- I do conclude that the
`patent is obvious, so I guess I am applying some
`kind of legal form. But it's based on my
`understanding of the science and my understanding
`of what was explained to me by the lawyers
`constitutes obvious.
`BY MS. KEANE:
` Q What did you do to prepare for your
`deposition today?
` A Had a good night's sleep.
` Q Did you do anything else?
` A Yes, we got together yesterday and
`reviewed some of the documents that are involved in
`the litigation. And I reread my declaration. And
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` ARTHUR H. KIBBE, PH.D.
`so I met with -- with counsel tomorrow --
`yesterday.
` Q And how long did you meet with counsel?
` A About five or six hours.
` Q And who was at the meeting?
` A Just the two of us (indicating).
` Q In the course of preparing for your
`deposition, did you review any documents other than
`the documents that are cited in Paragraph 5 of your
`declaration?
` MR. HOLLOWAY: Objection, form.
` A That's a good question because -- okay,
`so I reviewed the patent office's analysis, the
`petition.
`BY MS. KEANE:
` Q The institution decision?
` A Whatever it's called. And your side's
`answer to the petition, I guess that's what it's
`called.
` Q Okay. The --
` A Because, clearly, I didn't have them
`before I formed it.
` Q Okay. So you reviewed the patent owner's
`preliminary response, I take it?
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` ARTHUR H. KIBBE, PH.D.
` A I think so, that's what it was called.
` Q And did you review all of the documents
`associated with that paper?
` A Not in-depth. I looked at some of them.
` Q Okay. Did you review anything else
`during your preparation yesterday?
` A No.
` Q Sorry?
` A No, not that I remember.
` Q Okay. Other than your meeting yesterday
`and your review of documents yesterday, did you do
`anything else to prepare for your deposition today?
` A I just read the documents and here I am.
` Q Okay. Did you discuss your deposition
`today with anybody else other than the attorneys
`that you're working with?
` A No.
` Q If you could turn to Paragraph 50 of your
`declaration. And do you see in Paragraph 50
`there's listed there a construction for the term
`"gelling agent"?
` A Yes.
` Q Is that a construction that was provided
`to you by counsel?
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` ARTHUR H. KIBBE, PH.D.
` A Yes.
` Q And so you weren't asked to form an
`opinion with respect to the construction of that
`term?
` A No.
` Q And if you take a look at Paragraph 51,
`there is, again, a construction and this time it's
`for the term "gelling aid." Do you see that?
` A Yes.
` Q Okay. Was that construction provided to
`you by counsel?
` A It comes directly from the patent.
` Q Okay. And did you identify that
`construction in the patent or was that provided to
`you by counsel?
` A I don't remember who did which when,
`but...
` Q If you take a look at Paragraph 5 of your
`declaration. Do you see at the end of that
`paragraph it refers to, it states: And within the
`time frame of the earliest priority date of the
`claimed subject matter in the '180 patent -
`April 13th, 2000.
` A Right.
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` ARTHUR H. KIBBE, PH.D.
` Q Do you see that?
` A I see it.
` Q Okay. And then if you take a look at
`Paragraph 37. In the last sentence of
`Paragraph 37, it says: For purposes of this
`Petition only.
` I'm sorry, are you with me? It's on Page
`14 at the top of the page.
` A Oh, I'm sorry, I was looking at The
`patent was filed April 13th, 2000, which comports
`with what we said in 5, right?
` Q Right.
` And then if you turn to the top of Page
`14, it's the continuation of Paragraph 38. Or,
`sorry, the continuation of Paragraph 37. And it
`states there: For purposes of this Petition only,
`I assume the earliest priority date for the '180
`patent is April 14th, 1999. Do you see that?
` A Yes, that is clearly information that's
`based on legal opinions about the patent dates and
`when priority is established.
` Q Okay. So those dates were provided to
`you by counsel?
` A Well, they showed me where they were on
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` ARTHUR H. KIBBE, PH.D.
`the patent itself and why those dates were
`applicable.
` Q Okay. And which is the -- well, le