Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
`1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
` APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
`HOLDINGS, INC., AND APOTEX HOLDINGS, INC.,
`Petitioners
`v.
`OSI PHARMACEUTICALS, INC.,
`Patent Owner
`______________________
`CBM2016-01284
`U.S. Patent No. 6,900,221
`______________________
` DEPOSITION OF GIUSEPPE GIACCONE, M.D., Ph.D.
`
`Washington, D.C.
`Monday, August 14, 2017
`11:59 a.m.
`
`Reported by: Donna A. Peterson
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`OSI 2048
`APOTEX V. OSI
`IPR2016-01284
`
`
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
`1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
` APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
`HOLDINGS, INC., AND APOTEX HOLDINGS, INC.,
`Petitioners
`v.
`OSI PHARMACEUTICALS, INC.,
`Patent Owner
`______________________
`CBM2016-01284
`U.S. Patent No. 6,900,221
`______________________
` DEPOSITION OF GIUSEPPE GIACCONE, M.D., Ph.D.
`
`Washington, D.C.
`Monday, August 14, 2017
`11:59 a.m.
`
`Reported by: Donna A. Peterson
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`OSI 2048
`APOTEX V. OSI
`IPR2016-01284
`
`
`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
` Expert Deposition of GIUSEPPE
`GIACCONE, M.D., Ph.D., taken at the law offices of:
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` WILMER CUTLER PICKERING
` HALE and DORR, LLP
` Room 2001E, Second Floor
` 1875 Pennsylvania Avenue, N.W.
` Washington, D.C. 20006
`
` Pursuant to Notice, before Donna Ann
`Peterson, Notary Public in and for the District of
`Columbia.
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
` A P P E A R A N C E S
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`3
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` ON BEHALF OF THE APOTEX PETITIONERS:
` W. BLAKE COBLENTZ, ATTORNEY at LAW
` ERIC CHOI, ATTORNEY at LAW
` COZEN O'CONNOR
` 1200 NINETEENTH Street, N.W.
` Washington, D.C. 20036
` Telephone: (202) 912-4800
` wcoblentz@cozen.com
`
` ON BEHALF OF THE RESPONDENTS:
` AMY K. WIGMORE, ATTORNEY at LAW
` KEVIN M. YURKERWICH, ATTORNEY at LAW
` WILMER CUTLER PICKERING
` HALE and DORR, LLP
` Second Floor
` 1875 Pennsylvania Avenue, N.W.
` Washington, D.C. 20006
` Telephone: (202) 663-6000
` amy.wigmore@wilmerhale.com
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`www.hendersonlegalservices.com
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
` 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: Andrea Tiglio, Ph.D.
` Astellas US, LLC, on behalf of
` Respondents
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`www.hendersonlegalservices.com
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
`5
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` C O N T E N T S
`EXAMINATION OF GIUSEPPE GIACCONE, M.D., Ph.D.
` PAGE
` By Ms. Wigmore 7
` E X H I B I T S
` (Exhibits attached to the transcript.)
`EXHIBITS DESCRIPTION PAGE
`Exhibit 2034 Patent Owner's Notice of 11
` Deposition of Giuseppe
` Giaccone, M.D., Ph.D., under
` 37 C.F.R., Section 42.53
`Exhibit 2044 Declaration of Giuseppe 16
` Giaccone, M.D., Ph.D.
`Exhibit 2045 Article from European Journal of 64
` Cancer
`Exhibit 2046 Article from Journal of Clinical 74
` Oncology
`Exhibit 2047 Article from British Journal of 78
` Hospital Medicine
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`www.hendersonlegalservices.com
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`
`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
`6
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` PREVIOUSLY MARKED
`EXHIBITS DESCRIPTION PAGE
` 1001 U.S. Patent Number 6,900,221 22
` 1009 Prior art document 22
` 1053 Giuseppe Giaccone, M.D., Ph.D.'s 11
` Reply Declaration in IPR Number
` 2016-01284
` 2021 Declaration of Dr. Paul Bunn 36
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`11:59:58
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` P R O C E E D I N G S
`Thereupon,
` GIUSEPPE GIACCONE, M.D., Ph.D.,
`was called as a witness by counsel for Respondent,
`OSI Pharmaceuticals, Inc., and having been duly sworn
`by the Notary Public, was examined and testified as
`follows:
` MS. WIGMORE: Good afternoon,
`Dr. Giaccone. I'm Amy Wigmore with the law firm of
`Wilmer Hale, here on behalf of the Patent Owner, and
`with me are Kevin Yurkerwich and Andrea Tiglio. I'll
`give counsel the Petitioner an opportunity to
`introduce yourself.
` MR. COBLENTZ: I'm Blake Coblentz, from
`Cozen O'Connor, on behalf of Apotex. And with me is
`Eric Choi, on behalf of Apotex.
` EXAMINATION BY COUNSEL FOR OSI PHARMACEUTICALS, INC.
`BY MS. WIGMORE:
` Q. Doctor, could you please state your name,
`for the record?
` A. Giuseppe Giaccone.
` Q. Could you please state the city where you
`
`202-220-4158
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`Henderson Legal Services, Inc.
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`reside?
` A. Bethesda, Maryland.
` Q. Now, we were together for a deposition
`back in the month of April, and I believe at that
`time, that was your first deposition; is that
`correct?
` A. That's correct.
` Q. Have you been deposed any other times
`since then?
` A. No.
` Q. And do you understand that your answers
`here today are under oath?
` A. Yeah.
` Q. Now, is there any reason that you cannot
`provide complete and accurate and truthful testimony
`here today?
` A. No.
` Q. Now, the last time we met, we walked
`through some ground rules for depositions.
` A. Uh-huh.
` Q. I'd be happy to walk through those again,
`if necessary, but let me ask you, do you have any
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`questions before we proceed?
` A. I don't have questions, but maybe a brief
`introduction --
` Q. Sure.
` A. -- would be useful.
` Q. Sure. I think you know the way the
`process works is I will ask questions, and you will
`answer to the best of your ability. If your counsel
`objects, you should go ahead and answer, unless they
`instruct you specifically not to answer; is that
`clear?
` A. Yep, that's clear.
` Q. And I think perhaps the most important
`rule is for to us do our best not to talk over one
`another, so that our court reporter can record what's
`said. So I will do my best to wait for you to finish
`your answers before asking another question, and if
`you also could wait until my question is complete
`before giving an answer, that would be appreciated.
`Is that clear?
` A. Yep, that's clear.
` Q. And we need to use audible words, since
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`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`this is going to be a written transcript, so gestures
`and things of that nature won't come through on the
`transcript; is that clear?
` A. (Nods.) Unless they're very obvious.
` Q. And I think, finally, we should both try
`to keep our voices up, particularly since we have a
`little bit of construction noise in the background.
`So if you could just do your best to keep your
`answers --
` A. Yeah.
` Q. -- at a reasonable volume, that would be
`great. At any point, if you need a break, please let
`me know. We'll try to break at least every hour.
`And if you need a break in between then, the only
`thing I'd ask is that you just complete the answer,
`if there's a question pending; is that clear?
` A. Yeah, that's clear.
` Q. Okay. Any other questions before we
`proceed?
` A. No. Good to go.
` Q. So I'm going to put before you a new
`exhibit that will be marked as Exhibit 2043.
`
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` (Exhibit 2034 was marked for
`identification and attached to the transcript.)
`BY MS. WIGMORE:
` Q. What I've put before you, Exhibit 2043, is
`titled Patent Owner's Notice of Deposition of
`Giuseppe Giaccone, M.D., Ph.D., under 37 C.F.R.,
`Section 42.53.
` Do you recognize that exhibit?
` A. Yes.
` Q. Do you understand that you are appearing
`today pursuant to this deposition notice?
` A. Yes.
` Q. You can put that document aside, and keep
`the exhibits in front of you. We won't return to
`that one, but there may be others that we refer to
`repeatedly.
` I'd now like to put before you a document
`that's already been marked as Exhibit 1053.
` (Exhibit 1053 was referenced.)
`BY MS. WIGMORE:
` Q. Do you recognize Exhibit 1053 as your
`reply declaration in IPR Number 2016-01284?
`
`202-220-4158
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`Henderson Legal Services, Inc.
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` A. Yes.
` Q. If you could turn to the signature page at
`the end of the document. I will note, there are two
`page numbers on most documents we will be using
`today, but I'm going to be using the numbers on the
`right-hand side, where it says Apotex Exhibit
`1053-009.
` Do you have that page?
` A. Yes.
` Q. And is that your signature appearing on
`that page?
` A. Yes, it is.
` Q. How much time did you spend preparing this
`reply declaration?
` A. A few days.
` Q. Then did you work all day on those few
`days?
` A. No.
` Q. So approximately how many hours, in total?
` A. Well, I spent a couple weekends. So maybe
`24 hours, something like that.
` Q. In total?
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`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` A. Yeah.
` Q. If you could turn, please, to paragraph 4
`of your declaration. You indicate in the second
`sentence of paragraph 4, "I have reviewed Patent
`Owner OSI Pharmaceuticals, LLC's response, April 20,
`and the materials cited in Appendix A attached
`thereto."
` Do you see that?
` A. Sorry, can you point it to me?
` Q. Sure. It's the second sentence of
`paragraph 4, on page Apotex 1053-003.
` Do you have paragraph 4?
` A. Yeah.
` Q. And I'm focusing your attention on the
`second sentence of that paragraph, which appears
`under the heading Materials Reviewed.
` Do you see that?
` A. Yes.
` Q. And you say in the second sentence, "I
`have reviewed Patent Owner OSI Pharmaceuticals, LLC's
`response paper 20, and the materials cited in
`Appendix A attached thereto."
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`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` Do you see that?
` A. Yes.
` Q. And you go on to say you have "further
`reviewed the documents referenced herein," meaning in
`your reply declaration. Do you see that?
` A. Yes.
` Q. Are there any other documents or materials
`you considered in preparing this reply declaration,
`beyond those referenced in this paragraph?
` A. I have gone back to some of the literature
`that was published around that date regarding EGFR
`mutations and their frequency.
` Q. Regarding -- I'm sorry, what did you say?
` A. EGFR mutations and their frequency.
` Q. And you looked at those, but did not
`include them --
` A. That's correct.
` Q. -- in your declaration? Why not?
` A. Because I have included a paper of mine
`published in JCO, 2005, I think, that actually
`summarizes nicely what I looked again.
` Q. Okay. Let's -- I just want to make sure I
`
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`have that --
` A. Yeah.
` Q. -- publication in mind.
` Can you tell me where in your declaration
`you're referring to your own publication?
` A. It's one of the -- one of the papers that
`is in the -- in the packets.
` Q. Was this in the Patent Owner's responses
`that you referred to in paragraph 4 of your
`declaration?
` A. I don't remember what exhibit it is, but
`it is a paper that you have received as well for
`review.
` Q. Okay.
` A. That I wrote in JCO, 2005.
` Q. Okay. So just looking at your
`declaration, I'm not seeing, but correct me if I'm
`wrong --
` A. Okay.
` Q. -- you citing to any one of your own
`publications in your reply declaration; is that
`right?
`
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` A. Yes.
` Q. Let's look at the Patent Owner's response,
`which you cite in paragraph 4.
` A. Uh-huh.
` Q. I put that before you. So this is Exhibit
`2044 that has been newly marked.
` (Exhibit 2044 was marked for
`identification and attached to the transcript.)
` THE WITNESS: Okay.
`BY MS. WIGMORE:
` Q. The first question I have about this is
`you refer in paragraph 4 of your declaration to
`Appendix A.
` A. Yeah, I --
` Q. What were you referring to?
` A. I referred to the list of documents that
`were attached to the declaration. It's not called
`Appendix A.
` Q. Okay.
` A. So that -- that is a typo.
` Q. Okay. And then if you refer to that list
`of exhibits, could you identify, if it's there, the
`
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`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`publication of your own that you were referring to?
` A. No.
` Q. It's not there.
` A. No.
` Q. So where would I find the exhibit that
`you're referring to that was a publication authored
`by you?
` A. It would be in the documents that have
`been attached to this declaration.
` Q. To your declaration?
` A. Uh-huh.
` Q. I guess I'm wondering where those are. I
`don't see any attachments. Is it your understanding
`that you had attachments to your declaration, beyond
`the CV that you provided with your original
`declaration?
` A. Okay, well, I mean, the publication is in
`my CV, of course.
` Q. Okay. But is it your understanding you
`actually attached the publications to your
`declaration?
` A. There were documents that were attached to
`
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`this declaration, right?
` Q. Not to my knowledge.
` MR. COBLENTZ: I think he is referring to
`exhibits that may have been referred to. I don't
`know.
` THE WITNESS: Yes, uh-huh.
` MR. COBLENTZ: Okay. I'm just trying to
`clarify, so --
`BY MS. WIGMORE:
` Q. Well, as I understand it, the only list of
`materials that you've provided is in this paragraph 4
`of your reply declaration.
` A. Okay.
` Q. Are you aware of anything else?
` A. No.
` Q. And did you rely on anything else in
`forming these opinions?
` A. As I said, I looked at the literature at
`that time concerning frequency of EGFR mutations in
`the United States, and so that's what I reviewed in
`addition.
` Q. How did you determine what references to
`
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`review in preparing this reply declaration?
` A. It was mainly based on what I thought were
`important things to clarify in the second
`declaration.
` Q. Were any materials or publications
`provided to you by counsel?
` A. Yes.
` Q. What did they provide you?
` A. Well, it was information -- actually, my
`publication from 2005 in JCO that I looked again, and
`I thought it was very complete already. So we
`decided to use that as an exhibit.
` Q. But you're not seeing a reference to that
`exhibit in this reply declaration, correct?
` A. Well, if you give me a minute, I will find
`it.
` Q. Sure.
` A. On page 5, I say -- I discuss the
`frequency of EGFR mutations, and I say this accounts
`for about 10 percent of patients with non-small cell
`lung cancer in the United States. So I would suspect
`that either 1051 or 1048 is this exhibit I was
`
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`mentioning to you.
` Q. Okay. Did you do any literature searches
`in preparing this reply declaration?
` A. Yes, as I was telling you, especially
`concerning the frequency of EGFR mutations.
` Q. So you did literature searches and
`reviewed publications, but determined that they were
`duplicative of your own publication, is that correct?
` A. My publication was a review of that time,
`and it included the information that I wanted to put
`in here.
` Q. Now, in terms of communications with
`others, aside from counsel, did you have any
`communications with other people in preparing your
`reply declaration?
` A. No.
` Q. And who drafted your reply declaration?
` A. The lawyers.
` Q. Did you draft any portions of it yourself?
` A. The part concerning the EGFR mutations,
`making sure that the statements were correct, the
`frequency was double-checked.
`
`202-220-4158
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` Q. And that's paragraph 8?
` A. Yes, mainly. Of course, I went through
`the whole declaration multiple times.
` Q. Okay. If you could turn, please, to
`paragraph 5 of your declaration, Exhibit 1053. In
`the second sentence of paragraph 5, you say, "logic
`would dictate that a comparator is necessary to
`evaluate whether a result is unexpected."
` Do you see that?
` A. Yes.
` Q. What is the basis for your statement that
`a comparator is necessary to evaluate whether a
`result is unexpected?
` A. When you are evaluating something new, you
`would like to know if this is really new and
`unexpected, so you need a comparator.
` Q. And what do you mean by a "comparator"?
` A. Well, in the sense -- in the law sense, a
`comparator is something that is closest to -- to the
`present statement to -- so it is the closest prior
`art related to the statement. In this case, it would
`be Schnur.
`
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`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` Q. Now, can there only be one comparator when
`you're evaluating whether results were unexpected?
` A. I guess there could be more than one, but
`this is the closest.
` Q. Now, we're talking here, in the '221
`patent that's at issue in this IPR, about a method of
`treatment for non-small cell lung cancer, correct?
` A. Yes and no. The patent actually talks
`about method of treatment for non-small cell lung
`cancer in mammals.
` Q. Just in mammals, is that your
`interpretation?
` A. That what is written in the patent, '221.
` Q. Okay. Well, why don't we have a look at
`the '221 patent, which has been previously marked as
`Exhibit 1009.
` (Exhibit 1009 was referenced.)
` THE WITNESS: It's another one.
` MR. CHOI: Yeah, this is --
` THE WITNESS: This is the prior art.
` (Exhibit 1001 was referenced.)
`BY MS. WIGMORE:
`
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`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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` Q. So strike that. I'm handing you what's
`been marked as Exhibit 1001. Do you recognize this
`as U.S. Patent Number 6,900,221?
` A. Yes.
` Q. And turning to -- well, let me ask you,
`you indicated in a prior answer that this patent is
`limited to a method of treatment of non-small cell
`lung cancer in mammals. Did I characterize that
`accurately?
` A. Yes.
` Q. Okay. And how do you reach that
`conclusion?
` A. Well, I will have to go through this
`document again and find it.
` Q. Perhaps we could start with the claim.
` A. Yeah.
` Q. And the claim, as you know, that are at
`issue in this IPR are 44, which appears on column 35,
`45, 46, and 53. So all in column 35 of the patent.
`Let me know when you have gotten there.
` A. Yeah. So in 44, it's -- it reads, "a
`method of treatment of non-small cell lung cancer
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`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`periodically, and many other tumor types in mammal
`comprising -- administering to said mammal a
`therapeutically effective amount of erlotinib.
` Q. Okay. And is it your understanding that
`mammal excludes human patients or --
` A. It includes human patients.
` Q. Okay. So your understanding is that these
`claims cover the treatment -- a method of treatment
`for non-small cell lung cancer, and some other
`diseases, in mammals, which would include humans, is
`that correct?
` A. Yes.
` Q. Thank you for clarifying that. So turning
`back to the issue of the comparator, is it your
`understanding that there can be more than one
`comparator in determining whether there's an
`unexpected result?
` A. Yes.
` Q. And when a person of ordinary skill, in
`this case a medical oncologist, is analyzing whether
`there are unexpected results, would you want to know
`the standard of care for that particular disease at
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`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
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`the time of the invention?
` A. Yes.
` Q. And the time of the invention that we've
`been talking about in this case is March 30th of
`2000, is that right?
` A. Yes.
` Q. So at that time, what was the standard of
`care for advanced non-small cell lung cancer?
` A. It was chemotherapy.
` Q. You mentioned the term "closest prior art"
`in your declaration and in a prior answer.
` Do you recall that?
` A. Yes.
` Q. When was the first time you heard that
`phrase?
` A. Can you repeat, please?
` Q. When is the first time you heard the
`phrase, "closest prior art"?
` A. "Closest prior art," when we were
`preparing for this second declaration.
` Q. So that's not a phrase you used in your
`first declaration in this case, is that correct?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
`12:20:10
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` A. That is correct.
` Q. What do you understand "closest prior art"
`to mean?
` A. The document that is closest, in terms of
`time before the date of the patent.
` Q. And you state in paragraph 5 of your
`declaration that, in your opinion, the closest prior
`art is the Schnur reference, Exhibit 1009, correct?
` A. Yes.
` Q. Now, that's not an opinion you gave in
`your first declaration, you did not opine that Schnur
`was the closest prior art in your first declaration,
`correct?
` A. I think it is.
` Q. But in terms of what you offered in your
`first declaration in this case, that we had a
`deposition about in April --
` A. Uh-huh.
` Q. -- you had not offered the opinion that
`Schnur was the closest prior art, correct?
` A. I thought we were going to discuss this
`declaration today.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
`12:21:12
`
`12:21:13
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`12:21:15
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` Q. That's correct. I'm just trying to
`distinguish this declaration from your prior
`declaration. So we'll come to this one in a moment.
` But in terms of what you offered
`previously in your first declaration, in that
`declaration, you had not offered the opinion that
`Schnur was the closest prior art, correct?
` A. But it was.
` Q. And you've now stated that in your second
`declaration, correct?
` A. That's correct.
` Q. Now, were you asked to assume that Schnur
`was the closest prior art?
` A. Sorry?
` Q. Were you asked to assume, in preparing
`this reply declaration, that Schnur was the closest
`prior art to the challenged claims from the '221
`patent?
` A. No, I was not asked about that. Schnur
`essentially discloses -- as I wrote here, discloses
`the compound erlotinib, and has been effective to
`treat a range of conditions that involve inhibition
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Case No. CBM2016-01284
`Giaccone, M.D., Ph.D., Giuseppe
`
`August 14, 2017
`
`12:22:11
`
`12:22:15
`
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`of the EGF receptor, including lung cancer.
` Q. So that's what was the basis for your
`statement that Schnur was closest prior art in this
`reply declaration, is that correct?
` A. Yes.
` Q. Is there anything else that supported that
`opinion?
` A. No.
` Q. Did you, in analyzing what was the closest
`prior art, review any other literature or
`publications?
` A. The documents that we had discussed
`before, and that are discussed also here, the Gibbs
`publication and the K10 publication.
`
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