`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` _____________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _____________________________
` MODERNA THERAPEUTICS, INC.,
` Petitioner,
` v.
` ARBUTUS BIOPHARMA CORPORATION,
` Patent Owner.
` _____________________________
` Case IPR2019-00554
` Patent No. 8,058,069
` ___________________________
`
` DEPOSITION OF ANDREW S. JANOFF, PH.D.
` Princeton, New Jersey
` October 25, 2019
`
`Reported by:
`MARY F. BOWMAN, RPR, CRR
`JOB NO. 170698
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`ARBUTUS - EXHIBIT 2033
`Moderna Therapeutics, Inc. v. Arbutus Biopharma Corporation - IPR2019-00554
`
`
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`Page 2
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` October 25, 2019
` 9:00 a.m.
`
` Deposition of ANDREW S. JANOFF,
` PH.D., held at the Nassau Inn, 10 Palmer
` Square, Princeton, New Jersey, before Mary
` F. Bowman, a Registered Professional
` Reporter, Certified Realtime Reporter, and
` Notary Public of the State of New Jersey.
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` APPEARANCES:
`
`IRELL & MANELLA
`Attorneys for Petitioner
` 1800 Avenue of the Stars
` Los Angeles, CA 90067
`BY: MACLAIN WELLS, ESQ.
`
`WILSON SONSINI GOODRICH & ROSATI
`Attorneys for Respondent
` 701 Fifth Avenue
` Seattle, WA 98104
`BY: MICHAEL ROSATO, ESQ.
` LORA GREEN, ESQ.
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` IT IS HEREBY STIPULATED AND
` AGREED, by and between the attorneys
` for the respective parties herein, that
` filing and sealing be and the same are
` hereby waived.
` IT IS FURTHER STIPULATED AND
` AGREED that all objections, except as
` to the form of the question, shall be
` reserved to the time of the trial.
` IT IS FURTHER STIPULATED AND
` AGREED that the within deposition may
` be sworn to and signed before any
` officer authorized to administer an
` oath, with the same force and effect as
` if signed and sworn to before the
` Court.
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` Janoff
`ANDREW J. JANOFF,
` called as a witness by the parties,
` having been duly sworn, testified as
` follows:
`EXAMINATION BY
`MR. ROSATO:
` Q. Good morning, Dr. Janoff. Would
` you mind stating your full name for the
` record.
` A. Andrew S. Janoff.
` Q. And we have been through this a
` couple of times now, so you know how things
` work, but just a couple reminders to make
` things smooth and efficient.
` You understand that you are
` providing testimony under oath and you are
` expected to tell the truth?
` A. Yes.
` Q. Is there any reason you cannot
` provide competent testimony today?
` A. No.
` Q. And you will recall, I will try
` to make my questions clear. If they are
` not clear, you can ask for a clarification.
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` Janoff
` And I ask that you direct your questions to
` me rather than the gentleman sitting with
` you. Is that OK?
` A. Sure.
` Q. Thank you.
` Always important, but please
` remember to provide verbal responses to the
` answers. We have a tendency to nod and
` shake our heads which the court reporter
` has trouble with and will give me a hard
` time about. So I would really appreciate
` that.
` Of course, if you need a break at
` any time, just let me know. If there is a
` question pending, I will ask that you
` answer the question before breaking. Is
` that OK?
` A. Yes.
` Q. Now, you filed declarations in
` two different IPR proceedings related to
` this one, is that correct?
` A. I believe that's correct.
` Q. One was the IPR 2018 00680
` challenging U.S. Patent 9,404,127.
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` Do you remember that?
` A. Yes.
` Q. And I may refer to that as the
` '12 patent IPR and if I do, you will know
` what I am talking about?
` A. '12 or '127?
` Q. '127 IPR, referring to the patent
` number '127?
` A. Yes, that's right.
` Q. Thank you. The other IPR was IPR
` 2018 00739 challenging U.S. patent
` 9,364,435. Do you remember that?
` A. Yes, I think so.
` Q. I may refer to the patent as the
` '435 patent and the IPR as the '435 patent
` IPR, is that OK?
` A. Yes.
` Q. In the previous depositions, we
` identified some medical issues with your
` eyesight, and we are trying to make
` accommodations here. But if at any point
` you are having trouble reading documents,
` let me know and we can take a pause and
` take as much time as you need to review
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` Janoff
` those.
` A. Thank you.
` Q. For this proceeding, are you
` being compensated for your work?
` A. Yes.
` Q. Are you being paid an hourly
` rate?
` A. Yes.
` Q. What is that rate?
` A. 750 an hour.
` Q. Is all your compensation in this
` matter being paid at that hourly rate?
` A. Yes.
` Q. Are you receiving any
` compensation in the form of stock or equity
` of any kind?
` A. No.
` Q. Do you have any financial
` interest in Moderna?
` A. No.
` Q. Other than the IPO, do you have
` any formal relationship with Moderna?
` A. No.
` Q. What did you do to prepare for
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` your deposition today?
` A. I reviewed the relevant patents
` and I spent some time with counsel going
` over those patents yesterday, yesterday
` afternoon.
` Q. So you met with counsel yesterday
` afternoon as well?
` A. Yes, that's right.
` Q. Did you have any other meetings
` besides the one with counsel yesterday
` afternoon?
` A. No.
` Q. Let's hand you a copy of your
` declaration in this case. This is
` previously filed as Exhibit 1008. I'm
` handing you a copy.
` Do you recognize this document?
` A. Just give me a minute to look
` through it. But I believe so.
` This looks like my declaration
` for the '069 patent. That's how we are
` defining it.
` Q. Right, the '069 patent is the
` patent at issue in this IPR. Right?
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` A. Yes.
` Q. And when you're ready, can you
` turn to paragraph 26 of your '069
` declaration.
` A. Just give me a moment to find it.
` Can I read it?
` Q. Of course.
` A. OK. You wanted me to read 26?
` Q. Yes.
` And in paragraph 26, you mention
` other documents and materials identified in
` this declaration.
` Do you see that?
` A. My opinion expressed in this
` declaration are based on the petition and
` the exhibits cited in this petition and
` other documents and materials identified in
` this declaration.
` I'm just reading to my itself.
` Q. On the last page of your
` declaration, you state that you executed
` the declaration on January 2, 2019.
` Do you see that?
` A. Yes, I see it.
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` Q. Besides seeing a copy of the
` petition and the cited references you
` discuss in paragraph 26, were you asked to
` review any other materials prior to
` executing your declaration?
` A. I don't recall. I don't think
` so.
` Q. Prior to January 2, did you
` conduct any experimental testing in the
` course of preparing your declaration in
` this case?
` MR. WELLS: Objection to form.
` A. There was some testing, but the
` testing didn't work out because we were
` trying to use mRNA and the lab we were
` using was having difficulty encapsulating
` mRNA and was having difficulty with the
` controls and the data was inconsistent.
` So instead of continuing, we
` just, to save money, just cut it off. So
` there was no data that was reliable or
` consistent in that testing.
` Q. Was this the same experimental
` work that you had discussed previously in
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` the context of the '435 patent?
` A. I don't recall whether it was --
` I'm sorry, I don't recall if it was the
` '435 or '069. I believe it was the '069.
` It has been some time.
` Q. You said '069. So just so we are
` on the same page, the previous IPRs were
` thee '127 --
` A. That's right.
` Q. -- and '435. Are you referring
` to the '127?
` A. No, I'm referring to the '069.
` Q. OK. Was it the same batch of
` experiments in timing that you are
` referring to?
` A. So I'm confused. What -- were
` there experiments done on the '127 or '435?
` I just can't remember honestly.
` There were so many -- we were
` looking at so many patents and they are
` similar. There was some testing done. My
` recollection is that it was on '069. But I
` could be wrong.
` Q. And that was -- that occurred
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` prior to January 2, 2019?
` A. And I can't really say. I can go
` back and look at the records. I'm sorry, I
` didn't review that for this declaration.
` Q. OK. But whatever that was, it's
` not -- it's not cited or reflected in your
` declaration?
` A. There was some testing done, but
` the testing was inconsistent. The data was
` not reliable. So there is nothing that's
` reflected.
` MR. WELLS: Just if it is helpful
` to clear up, I believe that the testing
` he's referring to is the same testing
` that he referred to in his prior
` deposition.
` To my knowledge, it is not
` separate testing, but that's my
` understanding just to help clear things
` up.
` Q. And that's what I was getting at.
` A. I think that's true. I remember
` we had that discussion and it's the same
` discussion, that there was some testing
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` done and it was not useful. The data was
` not reliable. The data was not consistent.
` The controls didn't work out. And we just
` stopped rather than continue to spend money
` to try to get to work.
` Q. OK. I remember that
` conversation.
` It sounds like you're answering
` what I was getting at, which is, has there
` been any additional testing beyond that
` conducted?
` A. No.
` Q. OK. Thank you.
` At paragraph 28 of your
` declaration -- why don't you take a moment
` to look at that and let me know when you're
` there.
` A. Yeah, I see it.
` Q. So paragraph 28, you mention
` reserving the right to supplement your
` opinions. Do you see that?
` A. Yes.
` Q. And I take it that's not intended
` to reflect a concern of any inaccuracies,
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` is that a fair statement?
` A. That's true.
` Q. So you didn't believe your
` declaration was inaccurate?
` A. No, no.
` Q. Do you believe your testimony in
` the previous IPRs was accurate?
` A. Yes.
` Q. Let's talk about the discussion
` of level of ordinary skill in the art in
` your declaration. I'll direct you to
` paragraph 29. That's the next paragraph
` there.
` A. I'm just having trouble finding
` it because it's -- just give me a moment
` here. It goes on the other page, right?
` Yeah.
` Q. Pages 8 and 9?
` A. Yeah, OK. It's on two sides,
` that's my problem. So paragraph 29.
` Q. I'm referring to generally the
` section level of ordinary skill in the art
` that spans pages 8 and 9 and begins at
` paragraph 29. Just to get you oriented.
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` A. So just give me a chance to read
` this if I can.
` Q. Sure.
` A. OK, so I've read up to I believe
` the principles.
` Q. Do you see in paragraph 29, you
` reference a person of ordinary skill in the
` art at the time of the effective filing
` date of the application stated in the first
` sentence.
` A. So just let me read this.
` "It is my understanding that the
` '069 patent should be interpreted and how
` it would be read by a person of ordinary
` skill in the art at the time of the
` effective filing of the application."
` Yes, I see that.
` Q. And in the next paragraph,
` paragraph 30, you state, "I am familiar
` with the technology at issue and the state
` of the art of the earliest priority date of
` the '069 patent"?
` A. Yes.
` Q. House-cleaning question, I didn't
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` see the earliest priority date of the '069
` patent identified in your declaration. Do
` you happen to recall what that date is?
` A. No. But if you give me the '069,
` we could look for the priority date.
` Q. No problem. Handing you a copy
` of what has previously been marked Exhibit
` 1001.
` (Exhibit 1001, '069 patent
` previously marked for identification.)
` A. I have some notes that I can
` share with you that -- I took just to save
` some time to identify ranges and so forth
` that I thought we were going to discuss.
` Do you mind if I refer to them?
` Because I think I've written priority
` dates.
` Q. You can refer to whatever you
` like.
` A. And we will give you a copy.
` Q. I'll let you know if I need a
` copy, but I appreciate the offer.
` A. So just give me a moment.
` So where is the '069? This pile
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` here?
` Q. So I handed you a copy of the
` Exhibit 1001. That's it.
` Before you review the substance,
` just for the record, do you recognize this
` document that I've handed you?
` A. It looks to be, to me, without
` flipping through the whole thing, the '069
` patent.
` Q. OK, thank you.
` A. Now you're asking me for the
` priority date. This is something that I
` would usually ask my attorney to tell me
` because it's confusing. I can see whether
` I can find something on here that looks
` like a priority date.
` Q. I might be able to help you out.
` Do you see on the front cover the
` section titled, "Related U.S. application
` data""? It's on the left column.
` A. Yes.
` Q. Do you see a --
` A. It's a provisional filing, is
` that what you are asking me?
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` Q. Yes, what is that provisional
` application.
` A. So this is a provisional that
` must be related to this patent and it was
` filed on April 15, 2008.
` Q. Right. So you're referring to
` provisional application number 61045228
` filed on April 15, 2008? Is that correct?
` A. Yes.
` Q. Is that what you understand to be
` the earliest priority date?
` A. As I -- in my entire career in
` biotech, I've always asked for the advice
` of counsel with respect to earliest
` priority date because it's my understanding
` that sometimes they're disclaimers and
` there are legal issues that I'm not
` familiar with.
` But just on the face of this,
` this says there is a provisional
` application filed on April 2008. And
` without going into more detail, I assume
` this is likely the priority date.
` Q. What I'm asking about is the
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` timing of your testimony with regard to the
` person of ordinary skill at the time of the
` effective filing date. Was your analysis
` based on the perspective as of the time of
` April 15, 2008?
` A. I believe so. I think -- I think
` so. I believe so.
` Q. I would ask if at any point you
` are referring to a time period different
` than that, you let me know. Otherwise, my
` questions are going to be directed, for the
` state of the art, at the time as of that
` relevant time period?
` A. OK, that's fine.
` Q. As we talk about the perspective
` of the person of ordinary skill in the art
` at the time, the time we are talking about
` is prior to April 15, 2008? Does that make
` sense?
` A. Because if that is the earliest
` priority date -- and I'm not saying that
` I'm sure that it is -- but it is the
` earliest priority date, we are talking
` about a person of ordinary skill around
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` this time, yes.
` Q. OK. If it's not clear why I am
` asking, you can also look at paragraph 32
` in your declaration there.
` A. All right, give me a chance.
` I see this.
` Q. And you state, "I have considered
` the issues discussed in the remainder of
` this declaration from the perspective of a
` person of ordinary skill in the art."
` Do you see that?
` A. Yes.
` Q. So the timing is important. So I
` just want to make sure we are on the same
` page, the perspective of a person at the
` relevant time?
` A. And I go on to say, "Although I
` use this perspective, I do not believe any
` of the opinions would change if slightly
` higher or lower level of skill were
` adopted."
` Q. Right, but you're not referring
` to a different time period there, correct?
` A. No, we are referring to the same
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` time period.
` Q. OK. Great, thank you.
` For the skill level in the
` previous sentence -- and maybe this is what
` you were getting at -- that's where you're
` identifying a skill level. Do you see that
` paragraph 31?
` A. Show me -- I'm sorry, just give
` me a chance to.
` MR. WELLS: I think it's on the
` back of the page you are looking at.
` It's double-sided? I think paragraph
` 31 is on the left hand side there.
` A. It's here.
` Just give me a moment.
` MR. WELLS: Counsel, if at any
` point you don't want me to help him get
` to the paragraph --
` MR. ROSATO: I appreciate it
` actually, thank you.
` MR. WELLS: -- I'm happy not to.
` A. I'm just looking for paragraph 31
` for some stupid reason.
` MR. WELLS: 31 is right there.
`
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` A. OK. OK, I see it.
` Q. In the last sentence of that
` paragraph, you state, "This skill level is
` representative of authors/inventors cited
` herein."
` Do you see that?
` A. Of prior art cited herein, yeah,
` I do.
` Q. And that sentence references
` Exhibits 1002 through 1006.
` A. Yes.
` Q. What is the significance of
` referencing Exhibits 1002 through 1006.
` MR. WELLS: Objection to form.
` A. It's been some time since I've
` reviewed this. So can I see those
` exhibits? And then I can tell you.
` Q. Let me give you a copy of the
` exhibit list. I'm handing you a copy of
` the exhibit list that was included with the
` petition.
` MR. ROSATO: Counsel, take a
` look. I didn't include the whole
` petition. It's just an exhibit list,
`
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` but you can check for accuracy.
` Q. Let me know when you're ready,
` Dr. Janoff.
` A. I'm just following this. OK.
` Q. Do you see in the exhibit list,
` an entry for Exhibit 1002?
` A. This is the '435 patent?
` Q. That was my next question, what
` is identified as Exhibit 1002?
` A. It's the '435 patent.
` Q. What's identified as Exhibit
` 1003?
` A. It's the 196 PCT.
` Q. What's identified as Exhibit
` 1004?
` A. It's the 189 publication.
` Q. And identified as Exhibit 1005 is
` the 554 publication, correct?
` A. That's correct.
` Q. Identified as Exhibit 1006 is the
` Lin reference, is that correct?
` A. It appears to be.
` Q. Let's start with Exhibit 1002.
` I'm handing you a copy of that document.
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` (Exhibit 1002, '435 Patent
` previously marked for identification.)
` Q. Do you recognize this document?
` A. This appears to be the '435
` patent, but it's been some time since I
` have had a chance to peruse it.
` So if you ask me specific
` questions, I would like to a chance to read
` to the relevant parts.
` Q. Of course.
` A. But I do recognize this as the
` '435.
` Q. Thank you.
` As we discussed earlier, you
` previously submitted testimony in an IPR
` challenge to the '435 patent, is that
` correct?
` A. That's my recollection.
` Q. Please turn to the front page of
` the '435 patent. Do you see the section
` titled, "Related U.S. application data"?
` A. Yes.
` Q. That section begins reading,
` "Continuation of"?
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` A. Yes.
` Q. And it lists a number of patent
` applications there. Do you see that?
` A. Yes.
` Q. Do you see that one of those
` listed patents is the '069 patent?
` A. I'm reading.
` So this is where it refers to
` continuation of application 12,424,367,
` filed on April 25, 2009 now patent number
` 058069. So is that what you are referring
` to?
` Q. It is with one correction, I
` think you said April 25. And it says April
` 15, 2009.
` A. Let me check that.
` Yes, that's true.
` Q. And you've been inventor on
` several patents, I believe, so you may
` understand what it means for the '435 to be
` related to the '069 as the continuation,
` correct?
` A. I don't understand all of the
` legal implications, but I've heard the term
`
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` "continuation" before.
` Q. Do you understand what it means
` for one patent to be the parent of another?
` A. Again, if you were to ask me
` that, I would want advice of counsel.
` Q. OK. Let me hand you a copy of
` your declaration that was submitted in the
` '435 patent case.
` MR. WELLS: Counsel, I have a
` question. Can we go off the record for
` a second.
` (Recess; 9:30 to 9:33 a.m.)
` Q. Dr. Janoff, I'm handing you a
` copy of what is being marked in this case
` as Exhibit 2028.
` (Exhibit 2028, declaration of
` Andrew S. Janoff, Ph.D. marked for
` identification, as of this date.)
` Q. Do you recognize this document?
` A. Not yet. Give me a chance to
` look at this.
` This looks like my declaration
` involving the '435 patent. That's what it
` appeared to be.
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` Q. Correct. This is a copy of your
` declaration that was filed on the '435
` patent IPR. In that case, it was filed as
` Exhibit 1007. In this case, it's being
` marked as Exhibit 2028, for the record.
` And in a break, we had an issue
` of clarification that we discussed with you
` and counsel and I believe you tell me if I
` am being accurate here, that the point of
` clarification was that in paragraph 31,
` while you reference Exhibits 1002 through
` 1006, the intention was to reference
` Exhibits 1003 to 1007.
` A. I think that's correct.
` Q. I was asking about the '435
` patent and its relationship to the '069
` patent before we took a break for that
` correction.
` Do you remember that
` conversation?
` A. No.
` Q. I'll help orient you.
` A. I'm hopelessly now a little bit
` confused with all of these patents.
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` Q. Sure. We were looking at the
` cover of the '435 patent and identified
` reference to the '069 patent as a
` continuation. Do you recall that?
` A. I recall you stating that, yes.
` Q. We were then talking about what
` it means for patents to be related as
` continuations. Do you recall that?
` A. You were talking about that. I
` believe that I -- I can't give you an
` accurate answer because this is a legal
` issue that I've always asked advice of
` counsel for.
` Q. Can you look at paragraph 76 of
` your '435 declaration.
` A. Is this what I have in my hand?
` OK.
` So "During the prosecution," is
` that how this starts?
` Q. Yes. Take a moment to read the
` paragraph. And I'll be asking about the
` first sentence.
` A. Do you want to continue on and
` look at this table? Are you going to ask
`
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` Janoff
` me to look at the table?
` Q. I'm going to ask you about the
` first sentence.
` A. All right so -- I'm sorry.
` Q. Paragraph 76 of your '435
` declaration. It's on the previous page.
` A. I see the sentence, but you can
` go ahead and ask me. I would like to
` review the table perhaps depending on the
` question you're asking.
` Q. First sentence references
` prosecution of the application leading to
` the parent of the '435 patent. Do you see
` that?
` A. Yes.
` Q. And the sentence cites to the
` '069 patent file history. Do you see that
` at the end of the sentence?
` A. Give me a chance to look at this.
` So where do you want me to read
` to? I'm sorry.
` Q. The first, in the first sentence
` you are referring to the '069 patent as the
` parent of the '435 patent, is that correct?
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` A. Which reads, "During the
` prosecution of the application leading to
` the parent of the '435 patent," yes, I see
` that.
` Q. And by parent, you're referring
` to the '069 patent, correct?
` A. I believe so. Without looking at
` this whole thing, I think so.
` Q. OK. And we looked at the front
` of the '435 patent and saw that it relates
` to the '069 patent as a continuation,
` right?
` A. I remember that.
` Q. Let's turn back to the front
` cover of the '435 patent for a moment.
` A. OK.
` Q. Do you see the that section we
` were looking at titled, "Related U.S.
` application data"?
` A. Yes, I'm there.
` Q. Do you see the last entry in that
` section referring to provisional
` application 61045228?
` A. Yes.
`
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` Q. And that application was filed on
` April 15, 2008?
` A. Yes.
` Q. And that's the same provisional
` application that's referenced in the '069
` patent that we discussed earlier?
` A. I believe so.
` Q. Do you have a copy of the '069
` patent? It's there if you want to take a
` look. But if that's your recollection,
` that's OK too?
` A. I believe so. Without checking,
` I believe so.
` Q. Let's turn to the section "level
` of ordinary skill in the art" in your '435
` declaration. That's the section that
` begins at page 7.
` A. Let me do some housekeeping here.
` It begins on page --
` Q. 7.
` A. Point me to the paragraph.
` Q. The section covers paragraphs 29
` through 32.
` A. So page 7. Maybe I have the
`
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` wrong document, I don't see paragraph 29.
` MR. WELLS: That's page 5.
` That's a different number. You need to
` go off the page number in the middle, I
` believe, of the document.
` A. So page 7, paragraph what? I'm
` sorry.
` Q. Beginning page 7.
` A. Paragraph what?
` Q. 29. The section that is titled,
` "level of ordinary skill in the art"?
` A. I see it.
` Q. My question is whether there is
` any difference between how the level of
` ordinary skill in the art at the time is
` defined in your '435 declaration compared
` to how the same level of ordinary skill at
` the time is defined in the '069 patent
` declaration.
` MR. WELLS: Objection to form.
` A. OK, so --
` Q. I'm orienting you.
` A. I have to go back and look at
` both of them.
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` Q. I would open both documents then.
` A. OK, so I've got in front of me
` the '435. And you want me to look at
` the -- compare this to the '069. Is that
` correct?
` Q. Correct. And '069, in the '069
` declaration, that is, I'm referring to the
` section that covers paragraphs 29 through
` 32 in that declaration.
` A. In the '069? OK. Give me.
` MR. WELLS: It starts on the --
` over there.
` A. I'm having trouble seeing this.
` Q. Just to be clear where we are at,
` we are comparing paragraphs 29 through 32
` in the '069 declaration to paragraphs 29
` through 32 in the '435 declaration?
` A. OK.
` OK, so I just looked at paragraph
` 30 -- is it paragraph 30? For the '069.
` MR. WELLS: I think you were
` looking at paragraph 29.
` A. I am looking at paragraph 29 of
` the -- and this is the '069, correct?
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` OK. And you want me to compare
` that to paragraph 29 of the '435?
` Q. I'll just tell you I think the
` sections are virtually identically written
` and my question to you is whether that's an
` inaccurate interpretation?
` A. No, I stand by -- I stand by the
` record. I stand by my declarations.
` Q. OK. And --
` A. In other words, are you asking me
` whether these declarations are inaccurate?
` Q. That's not the question. The
` question is, to set the foundation, we have
` identified that the '435 patent and '069
` patent are related as continuations.
` A. Um-hm.
` Q. And we talked about the '069
` patent being a parent o