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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
` __________________________________
`
` MYLAN PHARMACEUTICALS INC., )
`
` MSN LABORATORIES PRIVATE LTD., )
`
` and MSN PHARMACEUTICALS INC., )
`
` Petitioners )
`
` vs. )
`
` BAUSCH HEALTH IRELAND LIMITED, )
`
` Patent Owner )
`
` ___________________________________
`
` CASE IPR2022-00722
`
` Patent 7,041,786
`
` - C O N F I D E N T I A L -
`
` Deposition of Stephen G. Davies, Ph.D.
`
` February 16, 2023
`
` 9:10 a.m.
`
` Reported by: Bonnie L. Russo
`
` Job No. 5696711
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`MYLAN EXHIBIT - 1060
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd.
`IPR2022-00722
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`Page 2
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` Deposition of Stephen G. Davies, Ph.D.
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` held at:
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` Finnegan Henderson Farabow
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` Garrett & Dunner, LLP
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` 901 New York Avenue, N.W.
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` Washington, D.C.
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` Pursuant to Notice, when were present on behalf
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` of the respective parties:
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` A P P E A R A N C E S :
`
` O n b e h a l f o f t h e P e t i t i o n e r :
` J A D M I L L S , E S Q U I R E
` R I C H A R D T O R C Z O N , E S Q U I R E
` T A S H A T H O M A S , E S Q U I R E
` W I L S O N S O N S I N I G O O D R I C H & R O S A T I
` 1 7 0 0 K S t r e e t , N . W . , 5 t h F l o o r
` W a s h i n g t o n , D . C . 2 0 0 0 6
` j m i l l s @ w s g r . c o m
` r t o r c z o n @ w s g r . c o m
` t t h o m a s @ w s g r . c o m
`
` O n b e h a l f o f t h e P a t e n t O w n e r :
` K A S S A N D R A O F F I C E R , E S Q U I R E
` J U S T I N J . H A S F O R D , E S Q U I R E
` L A U R E N R O B I N S O N , E S Q U I R E
` F I N N E G A N , H E N D E R S O N , F A R A B O W ,
` G A R R E T T & D U N N E R , L L P
` 9 0 1 N e w Y o r k A v e n u e , N . W .
` W a s h i n g t o n , D . C . 2 0 0 0 1
` k a s s a n d r a . o f f i c e r @ f i n n e g a n . c o m
` j u s t i n . h a s f o r d @ f i n n e g a n . c o m
` l a u r e n . r o b i n s o n @ f i n n e g a n . c o m
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` C O N T E N T S
` EXAMINATION OF STEPHEN G. DAVIES, Ph.D. PAGE
` BY MR. MILLS 6
`
` EXHIBITS
`
` PREVIOUSLY MARKED EXHIBITS:
` Exhibit 1001 United States Patent
` 7,041,786 B2
`
` Exhibit 1006 Article entitled
` "Purification, cDNA
` sequence, and tissue
` distribution of rat
` uroguanylin"
` Exhibit 2012 Article entitled
` "Uroguanylin: Structure
` and activity of a second
` endogenous peptide that
` stimulates intestinal
` guanylate cyclase"
`
` Exhibit 2021 International Publication
` Number WO 01/25266 A1
` Exhibit_2024 Declaration of
` Stephen G. Davies, D.Phil.
` (Redacted)
` Exhibit 2024 Declaration of
` Stephen G. Davies, D.Phil
` (Unredacted)
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` P R E V I O U S L Y M A R K E D E X H I B I T S ( C O N T I N U E D ) :
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` E x h i b i t 2 0 2 7 S t u d y e n t i t l e d
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` " S P - 3 0 4 : S t i m u l a t i o n
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` o f I n t r a c e l l u l a r c G M P
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` S y n t h e s i s i n T 8 4 C e l l s "
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` ( E x h i b i t s b o u n d s e p a r a t e l y . )
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` P R O C E E D I N G S
`
` (9:10 a.m.)
`
` STEPHEN G. DAVIES, Ph.D.,
`
` being first duly sworn, to tell the truth, the
`
` whole truth and nothing but the truth,
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` testified as follows:
`
` EXAMINATION BY COUNSEL FOR PETITIONER
`
` BY MR. MILLS:
`
` Q. Good morning.
`
` A. Good morning.
`
` Q. Please state your name for the
`
` record.
`
` A. Stephen Graham Davies.
`
` Q. And please provide your address for
`
` the record.
`
` A. 7 Apsley Road, Oxford, OX2 7QX,
`
` United Kingdom.
`
` Q. Dr. Davies, do you understand that
`
` you are under oath today the same as if you
`
` were in court in front of a judge, correct?
`
` A. I understand that, yes.
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` Q. I'm going to discuss the rules of
`
` deposition just to make sure that we all are
`
` clear.
`
` So the first rule is that it's
`
` important that you and I don't speak over one
`
` another.
`
` Do you understand that?
`
` A. I understand that.
`
` Q. I will do my best not to interrupt
`
` you, and I will ask you to do the same for me.
`
` Does that make sense?
`
` A. Okay.
`
` Q. If your counsel interposes any
`
` objections, you still need to answer my
`
` question unless counsel instructs you not to
`
` answer the question.
`
` Do you understand that?
`
` A. I understand that.
`
` Q. If at any point you don't understand
`
` a question that I ask you, will you tell us?
`
` A. I will.
`
` Q. Okay. Is there any reason that you
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` can't give your best, full, accurate testimony
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` today?
`
` A. No.
`
` Q. Dr. Davies, what did you do to
`
` prepare for your deposition today?
`
` A. I read through my declaration and
`
` some of the references therein in the patent.
`
` Q. Which references did you review in
`
` preparation for your deposition?
`
` A. I don't know. I don't recall. It
`
` was a random set.
`
` Q. Okay. Other than reviewing your
`
` declaration and a random set of references
`
` cited in your declaration, did you do anything
`
` else to prepare for your deposition today?
`
` A. I met with the attorneys yesterday.
`
` Q. For how long did you meet with the
`
` attorneys yesterday?
`
` A. I don't recall precisely. The -- it
`
` was morning and afternoon.
`
` Q. Other than meeting with the
`
` attorneys yesterday in preparation for your
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` deposition and the review of documents we've
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` already discussed, did you do anything else to
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` prepare for your deposition?
`
` A. I don't believe so.
`
` Q. Approximately how much time have you
`
` spent that will be billable to your client to
`
` prepare for your deposition today?
`
` MS. OFFICER: Object to form.
`
` THE WITNESS: I don't know. I keep
`
` an -- I send my accountant hours, and he
`
` prepares the bill. And so I don't keep track
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` of the total.
`
` BY MR. MILLS:
`
` Q. Is it more than ten hours?
`
` A. It will be more than ten hours, yes.
`
` Q. Will it be more than 20 hours?
`
` A. Total since I started looking at
`
` this?
`
` Q. Right now we are just asking about
`
` preparation for the deposition.
`
` A. Oh, it was on the plane coming over
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` and -- and whatever yesterday.
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` Q. Right. So what's your best
`
` estimate?
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` A. 15 hours, 14 hours, something like
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` that.
`
` Q. And you charge 450 British pounds
`
` per hour for the work; is that correct?
`
` A. That's correct.
`
` Q. Now I'm going to ask about a total
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` for your work on this case. What's your
`
` estimate for the amount of time that you have
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` billed or will be billable to your client for
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` your work on this case?
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` A. I --
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` MS. OFFICER: Object to form.
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` THE WITNESS: I can't -- I don't
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` know the answer. I don't keep track.
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` BY MR. MILLS:
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` Q. Is it more than 20 hours?
`
` A. I'm sure it's -- it must be more.
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` In total it must be more than 20 hours.
`
` Q. In total is it more than 40 hours?
`
` A. I really don't know.
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` Q. Could it be as many as a hundred
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` hours?
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` A. I doubt it.
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` Q. So your best estimate is that it's
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` somewhere more than 20 and less than a hundred;
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` is that correct?
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` MS. OFFICER: Object to form.
`
` THE WITNESS: I don't know how much
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` it was.
`
` BY MR. MILLS:
`
` Q. So you referred to your declaration
`
` and that you reviewed your declaration in
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` preparation for your deposition today.
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` Do you recall that testimony?
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` MS. OFFICER: Objection to the
`
` extent it mischaracterizes.
`
` THE WITNESS: I read my declaration
`
` in preparation for this, yes.
`
` BY MR. MILLS:
`
` Q. In reviewing your declaration in
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` preparation for your deposition, did you find
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` anything in your declaration, any errors that
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` you need to fix?
`
` MS. OFFICER: Object to form.
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` THE WITNESS: I don't think I found
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` any errors. I think there was a typo.
`
` BY MR. MILLS:
`
` Q. So other than the typo, there is
`
` nothing about your declaration that needs to be
`
` changed; is that correct?
`
` A. You would need to show me my
`
` declaration. I can see -- I can look for what
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` I'm -- I'm referring to and show you that.
`
` Q. Okay. So my question is: You
`
` mentioned a typo, so other than the typo that
`
` you found, is there any other error in your
`
` declaration that you found in your review when
`
` you were preparing for your deposition today?
`
` A. Only this -- only the one thing.
`
` Q. So is it fair to say that, sitting
`
` here today, you stand by everything that's
`
` written in your declaration other than the typo
`
` that you found?
`
` A. Yes. Yes.
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` Q. Okay. Coming here today do you have
`
` any new opinions that you are prepared to give
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` during your deposition that are not contained
`
` in your declaration?
`
` MS. OFFICER: Object to form.
`
` THE WITNESS: Not that I recall.
`
` BY MR. MILLS:
`
` Q. Dr. Davies, are you familiar with
`
` the '786 patent to Shailubhai?
`
` A. Yes.
`
` Q. And that's the patent that's at
`
` issue in this proceeding, correct?
`
` A. Correct.
`
` Q. Before signing your declaration, you
`
` reviewed the '786 patent; is that correct?
`
` A. That's correct.
`
` Q. Did you review the patent in its
`
` entirety?
`
` A. I read the patent, yes.
`
` Q. What portion of the patent did you
`
` turn to to understand what invention is at
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` issue in this proceeding?
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` MS. OFFICER: Object to form.
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` THE WITNESS: Well, I read the whole
`
` patent. I read the abstract, the claims, and
`
` then the whole patent, so I considered the
`
` whole patent.
`
` BY MR. MILLS:
`
` Q. Okay. You mentioned the claims in
`
` the patent.
`
` Do you have an understanding that
`
` the claims of the patent define the invention
`
` of the patent?
`
` MS. OFFICER: Object to form.
`
` THE WITNESS: Well, I understand
`
` that when we did a patent, you look at the
`
` claims in the context of the whole patent.
`
` MR. MILLS: Let's go ahead and hand
`
` out Exhibit 1001. This has been previously
`
` marked.
`
` MS. OFFICER: Thank you.
`
` BY MR. MILLS:
`
` Q. Dr. Davies, I have handed you what
`
` was previously marketed as Exhibit 1001. This
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` is the '786 patent that's at issue in this
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` proceeding; is that correct?
`
` A. That's correct.
`
` Q. And on the very last page of Exhibit
`
` 1001, there is a listing of six claims; is that
`
` correct?
`
` MS. OFFICER: Object to the
`
` extent -- or, actually, mischaracterizes.
`
` THE WITNESS: It's on the
`
` penultimate page of the document you gave me,
`
` the last page of the patent. There are six
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` claims, yes.
`
` BY MR. MILLS:
`
` Q. And you agree that the claims that
`
` are listed in columns 37 and 38 of the '786
`
` patent define the subject matter of the
`
` invention of the '786 patent?
`
` MS. OFFICER: Object to form.
`
` THE WITNESS: The claims -- a person
`
` of ordinary skill would read the claims in the
`
` context of the patent. We'd look at the whole
`
` of the patent.
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` BY MR. MILLS:
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` Q. Is there a difference between what
`
` the claims define as the invention of the '786
`
` patent and what the invention of the '786
`
` patent is according to the specification?
`
` MS. OFFICER: Objection. Calls for
`
` legal conclusion.
`
` THE WITNESS: I am a chemist, not a
`
` lawyer. So that's a legal question, not a
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` science question.
`
` BY MR. MILLS:
`
` Q. So the reason for my question is to
`
` understand your analysis, what it was that you
`
` were evaluating for obviousness purposes.
`
` So is it fair to say that when you
`
` were evaluating the obviousness of the
`
` invention of the '786 patent that you were
`
` evaluating what is listed in the claims 1
`
` through 6?
`
` A. I evaluated what is in the claims 1
`
` to 6 in the context of the whole patent,
`
` including the specification.
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` Q. Is there a difference between what
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` is listed in the claims and the -- what you
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` refer to as the context of the specification?
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` MS. OFFICER: Objection. Calls for
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` a legal conclusion.
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` THE WITNESS: That's -- that's a
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` legal question, not a science question.
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` BY MR. MILLS:
`
` Q. What I am trying to understand is
`
` what it was that you were evaluating the
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` obviousness of. So is there -- perhaps you can
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` tell us.
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` Please identify any context from the
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` '786 patent that you relied on to interpret the
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` meaning of the claims of the '786 patent?
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` MS. OFFICER: Objection. Vague.
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` THE WITNESS: I read -- as I've said
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` previously, I read the whole patent. I read
`
` the claims, and then I considered the claims in
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` the context of the whole specification.
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` BY MR. MILLS:
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` Q. Dr. Davies, you said earlier that
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` you reviewed the abstract of the '786 patent.
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` Do you recall that?
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` A. That's correct. I read the whole
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` patent. That includes the abstract.
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` Q. The first line of the abstract says:
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` "A method of treatment of inflamed precancerous
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` or cancerous tissue or polyps in a mammalian
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` subject is disclosed."
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` Do you see that?
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` A. That's what it says.
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` Q. And please take a look at Claim 1 of
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` the '786 patent.
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` A. Okay.
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` Q. Does Claim 1 require a method of
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` treatment of inflamed precancerous or cancerous
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` tissue or polyps in a mammalian subject?
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` MS. OFFICER: Objection. Legal
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` conclusion.
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` THE WITNESS: That's a legal
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` question that I don't know how to answer since
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` I'm not a lawyer. The claim is what it says.
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` BY MR. MILLS:
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` Q. So, Dr. Davies, you evaluated the
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` obviousness of claims 1 through 6 of the '786
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` patent, correct?
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` A. As it says in my report.
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` Q. When you were evaluating the
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` obviousness of Claim 1 of the '786 patent, was
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` it your understanding that Claim 1 of the '786
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` patent requires a method of treatment of
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` inflamed precancerous or cancerous tissue or
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` polyps in a mammalian subject?
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` A. That's -- as I said previously,
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` that's a legal question.
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` Q. Well, I haven't asked --
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` A. I don't need --
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` Q. I'm sorry.
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` A. -- I don't need that information to
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` understand what Claim 1 says.
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` Q. So that's my question. My question
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` isn't what a legal conclusion is.
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` My question is: What understanding
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` to the -- that you were bringing to Claim 1 as
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` you were evaluating it for its obviousness?
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` A. Whether I understand what Claim 1
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` says.
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` Q. Does Claim 1, as you understand it,
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` require a method of treatment of inflamed
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` precancerous or cancerous tissue or polyps in a
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` mammalian subject?
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` A. I think Claim 1 is for a peptide of
`
` the given sequence, and that's all.
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` Q. When you say "Claim 1 is for a
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` peptide of a given sequence and that's all,"
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` what sequence are you referring to?
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` A. The one that's named in Claim 1.
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` Q. And which sequence that?
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` A. ID No. 20.
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` Q. And can you point us to where the
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` '786 patent discloses the Sequence ID No. 20
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` that's the peptide claimed in Claim 1 of the
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` '786 patent?
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` MS. OFFICER: Object to form.
`
` THE WITNESS: So I look to Column
`
` 15, Line 57 where it identifies that sequence
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` as the peptide SP304, which is a purified
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` peptide creating 95 percent purity with the
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` sequence that is on Column 35. There are going
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` to be 20 lines on this one, but about all the
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` way down the page, it says -- oh, that's Line
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` 400. Oh, darn it. It says 400 sequence 20 and
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` then gives a sequence.
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` BY MR. MILLS:
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` Q. Okay. So, Dr. Davies, when you were
`
` providing your opinions in your declaration for
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` this case, was it your understanding that Claim
`
` 1 requires a peptide purified to 95 percent
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` purity of an amino acid sequence of Sequence ID
`
` No. 20?
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` MS. OFFICER: Object to form.
`
` THE WITNESS: I'm -- I'm reading the
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` claim in the context of the patent, and the
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` patent describes a peptide of this sequence
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` that has been purified to greater than 95
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` percent purity.
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` BY MR. MILLS:
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` Q. So that's the reason for my
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` question.
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` So you pointed to the 95 percent
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` purity, and my question is: Is it -- when you
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` were providing your opinions for your
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` declaration, were you interpreting Claim 1 to
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` require that the peptide be purified 95 percent
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` purity?
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` A. In the context of the patent, it has
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` been purified to 95 percent purity. Whether it
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` requires that for that claim, that's a legal
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` question.
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` Q. So, again, I'm not asking you for a
`
` legal conclusion, but I am entitled to know
`
` what it was that you were evaluating the
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` obviousness of.
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` And so I understand that you've
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` testified already that there is disclosure of
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` purifying a peptide to 95 percent purity. But
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` what I need to know is for your opinions that
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` you offered, do those opinions turn on a
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` construction that the claimed peptide must be
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` purified to 95 percent purity.
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` MS. OFFICER: Objection.
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` Argumentative. Legal conclusion.
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` THE WITNESS: I am saying that when
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` I evaluated this patent, I looked at Claim 1 in
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` context of the patent as a whole. And the
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` patent talks about the sequence which is on
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` Column 35, and also that sequence is referred
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` to in Column 15 as being a purified peptide.
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` BY MR. MILLS:
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` Q. So I still don't have an answer to
`
` my question. You've told us that the claim
`
` recites the Sequence ID No. 20, and you've told
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` us that Sequence ID No. 20 appears in Column 35
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` of the patent. And you've told us that the
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` patent also discloses purifying Sequence ID
`
` No. 20 to 95 percent purity.
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` What I need to know is whether for
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` the purposes of your opinions in your
`
` declaration whether it was your understanding
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` that the claim requires 95 percent purification
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` of the peptide.
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` MS. OFFICER: Objection. Asked and
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` answered. Mischaracterizes. Legal conclusion.
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` Argumentative.
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` THE WITNESS: As I have explained, I
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` looked at Claim 1. It gives a sequence number.
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` I find the sequence number in Column 35, and I
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` find the sequence number also in -- at least in
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` Column 15 where 15 describes purifying that
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` peptide of that sequence to greater than 95
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` percent purity.
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` BY MR. MILLS:
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` Q. So, Dr. Davies, what invention did
`
` you evaluate for your opinions regarding Claim
`
` 1? Was it an invention of a peptide that's
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` purified to 95 percent?
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` MS. OFFICER: Object to form.
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` THE WITNESS: As I have said, it's
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` -- I evaluated the Claim 1 which names the
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` sequence in the light of the patent as a whole
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` which gives a sequence and it gives a
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` purification of a -- of a peptide that is
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` greater than 95 percent.
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` BY MR. MILLS:
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` Q. So, Dr. Davies, you're telling us
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` that the specification gives a peptide that's
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` purified to greater than 95 percent, correct?
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` MS. OFFICER: Object to form.
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` THE WITNESS: It describes that
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` peptide greater than 95 percent pure.
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` BY MR. MILLS:
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` Q. You agree that the words in Claim 1
`
` don't say purified anywhere, correct?
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` A. Claim 1 does not say that, but I --
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` as I said, I evaluate -- I evaluated the claims
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` in the light of the whole specification.
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` Q. So the way that you were evaluating
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` Claim 1 is based on the specification you were
`
` reading in the word "purified to 95 percent";
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` is that correct?
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` MS. OFFICER: Objection.
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` Mischaracterizes.
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` THE WITNESS: I am reading Claim 1
`
` in the context of the patent, which gives me
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` the sequence and then gives me, in Column 15,
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` that it's a peptide that is purified to greater
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` than 95 percent.
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` BY MR. MILLS:
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` Q. But, Dr. Davies, when you evaluated
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` Claim 1 for obviousness, your evaluation
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` required that the peptide of Claim 1 be
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` purified to a purity greater than 95 percent;
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` is that correct?
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` MS. OFFICER: Objection. Asked and
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` answered. Mischaracterizes.
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` THE WITNESS: I evaluated Claim 1 in
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` the context of the whole specification which
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` includes the sequence on Column 35 and on
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` Column 15 where it says it's a purified peptide
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` at greater than 95 percent.
`
` BY MR. MILLS:
`
` Q. So, Dr. Davies, you've answered
`
` several times about -- that there is a
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` disclosure in the specification of a peptide
`
` that is purified to 95 percent. What I don't
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` have from you still is a clear answer as to
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` whether when you were evaluating the
`
` obviousness of Claim 1 you were interpreting
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` Claim 1 to require purification of 95 percent.
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` And that's what -- I am entitled to that
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` answer.
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` So can you please tell me whether
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` for your obviousness determination you
`
` interpreted Claim 1 to require purification to
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` 95 percent?
`
` MS. OFFICER: Objection. Asked and
`
` answered.
`
` THE WITNESS: I have explained as
`
` best I can how I evaluated Claim 1 which is in
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` the context of what it says in Claim 1 and in
`
` the specification as I've described.
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` MR. MILLS: I'm going to ask the
`
` witness to leave the room for just a moment. I
`
` need to speak with opposing counsel on the
`
` record.
`
` BY MR. MILLS:
`
` Q. Can you just step out for just a
`
` moment.
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` MR. HASFORD: No. No. What do you
`
` need to speak with us on the record about?
`
` MR. MILLS: So, first of all, I need
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` to know which counsel is defending the
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` deposition because there are two counsel
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` speaking --
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` MR. HASFORD: No. It's not --
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` MR. MILLS: -- and it's
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` distracting -- well, there is. Every time I
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` ask a question, you speak and then she speaks.
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` MR. HASFORD: I don't speak. I
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` whispered some things to her, which I'm
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` entitled to do so...
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` MR. MILLS: But it's distracting to
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` the witness because you have a very visible
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` reaction every time there is a question asked.
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` MR. HASFORD: He can't see me. I am
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` sitting on this side of the table, and he is
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` not looking over here, and you know he is
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` not --- -
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` MR. MILLS: You're making --
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` MR. HASFORD: -- so quit
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` mischaracterizing things --
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` MR. MILLS: You're making --
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` MR. HASFORD: -- you are
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` mischaracterizing things. You know it, and you
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` are not entitled to sit here and harass the
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` witness like you are doing --
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` MR. MILLS: So --
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` MR. HASFORD: -- if you want to the
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` ask him stuff about his declaration, show him
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` his declaration and ask him stuff about his
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` declaration.
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` MR. MILLS: I am not harassing the
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` witness --
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` MR. HASFORD: Yes, you are.
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` MR. MILLS: -- I am not
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` mischaracterizing things --
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` MR. HASFORD: You sure are.
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` MR. MILLS: -- and there needs to be
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` one counsel from your side who is -- who is
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` defending the deposition.
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` MR. HASFORD: Which -- which is.
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` It's Kassie. It's not me.
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` MR. MILLS: Okay.
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` MR. HASFORD: And I am entitled to
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` whisper stuff to her.
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