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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________________
`AMNEAL PHARMACEUTICALS LLC )
`and AMNEAL PHARMACEUTICALS )
`OF NEW YORK, LLC )
` )
` Petitioners )
` )
`vs. )
` )
`ALMIRALL, LLC )
` )
` Patent Owner )
`______________________________
`
` Case: IPR 2019-00207
` U.S. Patent No. 9,517,219
` Deposition of Elaine S. Gilmore, M.D.
` Washington, D.C.
` December 12, 2019 at 7:59 a.m.
`
`
`Reported by: Bonnie L. Russo
` ______________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
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`www.DigitalEvidenceGroup.com
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`Almirall EXHIBIT 2069
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`Amneal v. Almirall
`IPR2019-00207
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`Amneal Pharmaceuticals, et al., v. Almirall, S.A.
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`Elaine Gilmore, M.D.
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`Deposition of Elaine S. Gilmore, M.D. held at:
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`Page 2
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` Sterne Kessler Goldstein & Fox, LLP
` 1100 New York Avenue, N.W.
` Washington, D.C.
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`Pursuant to Notice, when were present on behalf
`of the respective parties:
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`APPEARANCES:
`
`On behalf of the Petitioners:
` ADAM C. LaROCK, ESQ.
` TYLER LIU, ESQ.
` STERNE KESSLER GOLDSTEIN & FOX
` 1100 New York Avenue, N.W.
` Washington, D.C. 20005
` 202-371-2600
` alarock@sternekessler.com
` tliu@sternekessler.com
`
`On behalf of the Patent Owner:
` R.J. SHEA, ESQ.
` FENWICK & WEST, LLP
` 902 Broadway
` Suite 14
` New York, New York 10010
` 212-921-2001
` rshea@fenwick.com
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` C O N T E N T S
`EXAMINATION OF ELAINE S. GILMORE, M.D. PAGE
`BY MR. SHEA 6
`BY MR. LaROCK 185
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`Page 4
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` PREVIOUSLY MARKED EXHIBITS
` PAGE
`Exhibit 1001 United States 11
` Patent 9,517,219 B2
`Exhibit 1004 International Publication 6
` Number WO 2009/061298 A1
`Exhibit 1018 Declaration of Elaine S. 89
` Gilmore, M.D., Ph.D.
`Exhibit 1019 Curriculum Vitae of 15
` Elaine S. Gilmore,
` M.D., Ph.D.
`Exhibit 1044 Second Declaration of 78
` Elaine S. Gilmore,
` M.D., Ph.D.
`Exhibit 1048 Article entitled 160
` "The Efficacy and
` Tolerability of Dapsone
` 5% Gel in Female vs Male
` Patients With Facial Acne
` Vulgaris: Gender as a
` Clinically Relevant
` Outcome Variable"
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`EXHIBITS (CONTINUED):
` PAGE
`Exhibit 1077 Third Declaration of 186
` Elaine S. Gilmore,
` M.D., Ph.D.
`Exhibit 2001 International Publication 121
` Number WO 2009/108147 A1
`Exhibit 2024 Review Article entitled 54
` "Current topical and
` systemic approaches to
` treatment of rosacea"
`Exhibit 2055 Declaration of 14
` Leon H. Kircik, M.D.
` in Support of Patent
` Owner's Response to
` Petition for Inter Partes
` Review
`
`(Exhibits included with transcript.)
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` P R O C E E D I N G S
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`Page 6
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` ELAINE S. GILMORE, M.D.,
`was called for examination by counsel and,
`after having been duly sworn by the Notary, was
`examined and testified as follows:
` EXAMINATION BY COUNSEL FOR PATENT OWNER
` BY MR. SHEA:
` Q. Good morning.
` Thanks for being here. We'll try to
`make this as quick and painless as possible.
` So I understand that you've done a
`couple depositions before, even related to the
`dapsone formulations and stuff; is that right?
` A. Correct.
` Q. So you just understand the basic
`gist of the depositions and how they go?
` A. Yes.
` Q. Okay. So just a few housekeeping
`things.
` I'm going to hand you your
`declaration. It's Exhibit 1044.
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` And that's your declaration that you
`signed I believe on October 31st, 2019, right?
` A. Yes.
` Q. And have you had a chance to review
`that since then?
` A. Yes.
` Q. Do you have any edits or corrections
`or comments that you would like to change about
`the declaration?
` A. Yes. I have several reference
`errata to report.
` Q. Okay. And hold on.
` MR. LaROCK: I'll just read them.
` BY MR. SHEA:
` Q. And what would those be?
` A. Both pertaining to the reply
`declaration as well as my third declaration,
`which you haven't given me yet.
` On my reply declaration on page 11,
`paragraph --
` Q. I'm sorry. So we're on Exhibit
`1044, right?
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` A. Yes.
` Q. And that's your second declaration?
` A. Yeah. I call it the reply
`declaration, yes.
` Q. Well, on the cover page, it just --
`just so we're clear --
` A. Second declaration.
` Q. Yeah. Second declaration.
` A. Yes.
` Q. Okay. So this is the one that
`we're -- you have comments or corrections on?
` A. Yes.
` Q. Okay. So when you're ready, do you
`just want to direct me to the paragraph that
`you're...
` A. On Page 11, the third bullet point
`should say "Exhibit 2019."
` Q. So instead of Exhibit 2031, 2039?
` A. No. The third bullet point.
` Q. On that page.
` A. On that page.
` Q. So instead of Exhibit 2009, Exhibit
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`2029?
` A. 2019.
` Q. 19. Okay.
` A. And on the last line of that same
`bullet point, the same reference, Exhibit 2019.
` Q. Okay.
` A. And those are all the changes I have
`for the second declaration.
` Q. Okay. Let's just stop there. And
`then, when we get to the exhibit that you have
`another correction for -- do you have the
`exhibit numbers that you have corrections for?
` A. Yes. So in different paragraphs.
`So we have "Exhibit 1065," which needs to be
`deleted from two of the sentences.
` Q. I'm sorry. So let me just clarify.
` You want to make corrections to
`Exhibit 1065?
` A. I want to change the number of the
`exhibit in the sentence.
` Q. In Exhibit 1044 or Exhibit 1065
`that --
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` A. I don't know what the exhibit is
`going to be named, but it's the third
`declaration. Not this one. The third
`declaration.
` MR. LaROCK: There was a
`supplemental declaration having to do with
`authenticating certain evidence that was served
`on counsel.
` MR. SHEA: Okay. Let's get to that
`one when we get there.
` THE WITNESS: Okay.
` BY MR. SHEA:
` Q. I was confused as to what the edits
`were, if it was in this declaration or if it
`was in a different declaration.
` A. We've taken care of edits for this
`declaration.
` Q. Okay. And then what other exhibits
`would you like to make corrections to?
` A. So nothing further in the second
`declaration.
` Q. Yep.
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` A. In the third declaration, it's just
`citations to different references.
` Q. Sure.
` And then are there any other
`exhibits that you want to make changes to?
` A. It pertains to the same exhibit
`cited in two different paragraphs in that other
`-- it's -- it was an omission.
` Q. Okay. All right. Sounds good. So
`we'll get to that one when we're -- when we do
`it.
` So as far as Exhibit 1044, your
`second declaration, are there any other
`corrections or comments that you have on that?
` A. No.
` Q. Okay. I'm going to hand you now
`Exhibit 101 [sic], which is U.S. Patent
`9,517,219.
` I'll just refer to that as the '219
`patent.
` You understand that?
` A. Yes.
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` Q. And you understand that this is the
`patent at issue for this IPR?
` MR. LaROCK: This is Exhibit 1001?
` MR. SHEA: Yes.
` MR. LaROCK: Okay. I thought you
`said 101. Sorry.
` THE WITNESS: Yes.
` BY MR. SHEA:
` Q. So you understand that this is the
`patent at issue today?
` A. Yes.
` Q. And just more housekeeping, just
`terms.
` When I say a POSA, P-O-S-A, you
`understand that to mean a person of ordinary
`skill in the art?
` A. Yes.
` Q. And if we just turn to the claims of
`the patent, which is on the last page there,
`Column 16, you see in Claim 2 it says
`"diethylene glycol monoethyl"?
` If we refer to that as DGME, would
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`you understand that?
` A. I can understand that would be an
`abbreviation.
` Q. Sure.
` A. I'm not a formulator of medications.
` Q. Understood.
` Just for shorthand, if we refer to
`it as DGME, you'll understand it references
`that term?
` A. Understood.
` Q. And likewise, in Claim 3, it says
`"polymeric viscosity builder."
` If we refer to that as PVB for
`shorthand, is that okay?
` A. I understand.
` Q. And then the last one in Claim 6, it
`says "acrylamide\sodium acryloyldimethyl
`taurate copolymer."
` If we just refer to that as ASA for
`shorthand, is that okay?
` A. That's okay.
` Q. Okay. And then this is also just --
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`Page 14
`I'm going to hand you Dr. Kircik's declaration,
`which is Exhibit 2055.
` And that -- this is just for your
`reference, just in case you need to refer to it
`throughout the deposition or anything like
`that.
` So in the deposition, I'm going to
`ask you questions, and you will understand that
`the court reporter will record your answer.
` Do you understand that?
` A. Yes.
` Q. And you understand that a verbal
`response is needed, you know, head nods or
`"uh-huh" won't work?
` A. I understand.
` Q. And because we have a court reporter
`here, if you just let me finish my question,
`and likewise I'll let you finish your answer,
`and that will keep the record clean.
` Will that work too?
` A. Yes.
` Q. Okay. And if you find one of my
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`questions ambiguous or difficult, if you could
`just state that while -- in your response. And
`then I can clarify.
` If you don't state anything, I'll
`just assume that you understood the question.
` A. Okay.
` Q. And you also understand that you're
`under oath today?
` A. I understand.
` Q. Okay. And is there any reason why
`you can't provide truthful or accurate
`testimony today?
` A. No.
` Q. Okay. Dr. Gilmore, I just want to
`talk to you a little bit about your CV, which
`I'm handing to you. It's Exhibit 1019.
` That's your CV, correct?
` A. Yes.
` Q. Do you have any updates, any new
`papers, anything that you want to add to that?
` A. I have new international
`presentation from September of this year that's
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`not included.
` Q. Did that presentation concern
`dapsone or dapsone formulations?
` A. No.
` Q. Was it concerning dermatology?
` A. Yes.
` Q. And just generally, what was it
`about?
` A. Allergic contact dermatitis related
`to particular topical therapies for cutaneous
`lymphoma.
` Q. Okay. So would acne or rosacea have
`been involved in that at all?
` A. No.
` Q. Now, in your declaration on
`Paragraph 20 -- I'll give you a minute to the
`get there -- you just describe a POSA as
`possessing an M.D. with a board certification
`in dermatology with at least two years of
`experience in dermatology or otherwise treating
`skin conditions.
` Is that accurate?
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` A. I don't see that in Paragraph 20.
` MR. LaROCK: Where are we?
` BY MR. SHEA:
` Q. On Paragraph 20 of your first
`declaration. I'm sorry. Here I'll give that
`to you. I'm sorry. I'm sorry for -- I don't
`mean to bombard you with a bunch of exhibits
`here.
` Paragraph 20.
` A. Could you repeat your question,
`please.
` Q. Yeah.
` Does Paragraph 20 accurately
`describe what you consider a POSA?
` A. It accurately describes my
`impression of a clinical POSA.
` Q. And when I say "priority date" or
`"at the time of the invention," you understand
`that that would be November 20th, 2012, the
`priority date of the patent, '219 patent?
` A. I understand that.
` Q. You were a resident from 2004 to
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`2007; is that right?
` A. Correct.
` Q. And then you were just a research
`fellow from 2006 to 2008?
` A. I was also practicing dermatology.
` Q. Sure.
` So from your research fellow or your
`residency, how many years would you consider
`yourself a POSA until the time of the
`invention?
` MR. LaROCK: Objection. Vague.
` THE WITNESS: So as I indicated in
`the first deposition, I said it is also
`possible that an MD without a certification in
`dermatology, i.e., primary care physician or a
`pediatrician, may qualify as a clinical POSA,
`assuming that they have more than two years of
`knowledge and experience treating skin
`conditions.
` So I graduated from medical school
`in 2003. And then was involved in clinical
`medicine from that point forward.
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` Q. So just focusing on your time from
`when you were a resident to the time of the
`invention, how many papers or publications did
`you publish?
` I will direct you to Page 2 of your
`CV there. I believe it starts on No. 11 there.
` Would that be within -- before the
`time of the invention?
` A. Yes.
` Q. And then it goes down to No. 17,
`which is Huang.
` Do you see that one on page 3?
` A. I see the reference.
` Q. And would that be your first paper
`after graduating med school?
` A. Yes.
` Q. So from those two, 11 to 17, you
`published seven papers between residency and
`the time of the invention?
` A. Yes.
` Q. Were any of those papers related to
`dapsone?
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` A. No.
` Q. Were any of them related to topical
`formulations?
` A. I don't recall the full contents of
`what was included in Reference No. 15. It was
`a book chapter. And I have not reviewed that
`in many years, so I'm not sure what's included
`in there, whether there are topical treatments
`or not.
` Q. And other than 15, were any of them
`concerning topical formulations?
` A. No.
` Q. Were any related to acne or rosacea?
` A. No.
` Q. And, Dr. Gilmore, before the
`priority date -- and I'll just direct you to
`Kircik's declaration at Paragraph 5, which I
`believe is Exhibit 2055.
` Before the priority date, were you
`invited to any present -- professional
`presentations or professional talks in the
`industry?
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` A. What do you mean by "invited to any
`professional talks"?
` Q. Did academia, did the private
`sector -- was anybody hired -- did anybody hire
`you to give professional talks?
` And I would direct you to Page 3 of
`your CV, where you list out your presentations
`and national and international presentations.
` MR. LaROCK: Objection. Vague.
` THE WITNESS: So typically, with
`scientific research publications, you're not
`hired to give them. It's more likely you are
`invited to speak at different meetings. So
`being hired by someone to do something is not
`really an honor.
` BY MR. SHEA:
` Q. Sure.
` And what I'm just getting at, if you
`look at Page 3 of your CV, if you were hired,
`invited to give any presentations before the
`date of the invention.
` A. Well, I don't know -- it looks like
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`the date of the invention you have as November
`20th, 2012. I'm not sure when I was invited to
`present at Nephrology Grand Rounds, also
`November 2012.
` Q. Okay. So -- and just -- sorry.
` I'm -- what one are you referencing
`there?
` A. Management of Uremic Pruritis,
`University of Rochester, Nephrology Grand
`Rounds.
` Q. So other than that --
` A. That's not something you're paid to
`do.
` Q. Sure.
` And other than that, were there any
`other presentations that you were invited,
`hired to give before the date of the invention?
` MR. LaROCK: Limited to her CV?
` MR. SHEA: Limited to her
`experience.
` THE WITNESS: I don't see it listed
`here. I can remember giving presentations at
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`the American Academy of Dermatology when I was
`a resident. I don't have it here.
` BY MR. SHEA:
` Q. You said the management of uremic
`pruritis.
` Does that have to do with dapsone
`formulations?
` A. No.
` Q. Also, Dr. Gilmore, prior to the date
`of the invention, were you on the editorial
`board of any journals?
` A. No.
` Q. Were you a consultant to the private
`industry at all before the date of the
`invention?
` A. No.
` Q. Were you invited to any symposiums
`or industry meetings before the date of the
`invention?
` A. No.
` Q. Before the priority date, were you
`involved in clinical studies at all?
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` A. Yes.
` Q. What clinical studies would those
`be?
` A. They were ongoing clinical trials in
`the department when I was a resident at Yale.
`And I've been involved in clinical trials
`regarding cutaneous lymphoma when I was at the
`University of Rochester and since.
` Q. You said you were involved as a
`resident.
` For those clinical trials, what was
`the topic about there?
` A. I don't remember specifically.
` Q. But it wasn't about dapsone
`formulations?
` A. No.
` Q. Was it about topical formulations?
` A. I don't recall.
` Q. And your role in those clinical
`trials, what would that be?
` A. Mainly as an observer.
` Q. So you didn't influence or direct
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`the clinical design at all?
` A. No.
` Q. You didn't help design it?
` A. No.
` Q. And you mentioned another clinical
`trial after your residency, correct?
` A. Yes.
` Q. Was that clinical trial about
`dapsone?
` A. No.
` Q. Was that clinical trial about
`topical formulations?
` A. Yes.
` Q. And was it -- was that clinical
`trial about acne or rosacea?
` A. No.
` Q. And again, what was your role for
`that clinical trial?
` A. Coinvestigator.
` Q. And as a coinvestigator, what would
`your duties be?
` A. Evaluate patients responses, design,
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`patch testing, assessments.
` Q. And what year was that?
` A. It's current.
` Q. Ongoing -- so --
` A. Ongoing.
` Q. So it started before?
` A. There were other trials that have
`started and ended basically since 2008.
` Q. Okay. So I'm not talking about the
`clinical trial that you're currently in.
` You said that -- I asked, before the
`priority date, if you were involved in any
`clinical trials, right?
` You understood that?
` A. Yes.
` Q. And you said that there was the one
`as a resident, and then you said there was
`another one that you were -- while you were at
`New Haven; is that right?
` MR. LaROCK: Objection to the extent
`it mischaracterizes her testimony.
` THE WITNESS: That's not what I
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`said.
` BY MR. SHEA:
` Q. Sure.
` I'm not trying to mischaracterize it
`at all. And I apologize. I'm just trying --
`I'm a little confused, so I'm just trying to
`understand.
` What clinical trials did you do
`before the priority date?
` A. There were clinical trials that
`started in 2008 when I was at the University of
`Rochester, in which I was a coinvestigator,
`that have run their course and completed.
` We always have ongoing clinical
`trials, of which I am part.
` Q. Sure.
` So the clinical trial in 2008, when
`did that end?
` A. I don't remember the specifics.
` Q. And that clinical trial in 2008, you
`said you were a coinvestigator.
` So what would that role be for that
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`2008 clinical trial?
` A. Evaluating patient responses to
`treatment, physical exams. Another clinical
`trial evaluating a microscopy evaluation of
`nevi in the skin.
` Q. Sure.
` A. I've been involved in many clinical
`trials.
` Q. And I understand. I'm just trying
`to focus on the 2008 one.
` So for that 2008 clinical trial, was
`that involving topical formulations?
` A. I don't remember specifically. I
`think that might have been an infusion. But
`there have been many clinical trials that I
`have been involved in.
` Q. And --
` A. Some are topical; some are oral;
`some are infusional; others were
`microscopy-directed.
` Q. And for that 2008 clinical trial,
`that didn't involve dapsone?
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` A. Yes. That didn't involve dapsone.
` Q. And that clinical trial -- 2008
`clinical trial was not about acne or rosacea?
` A. Correct.
` Q. Okay. And so before the priority
`date, you were involved in two clinical trials,
`one while you were a resident and then one in
`2008; is that correct?
` MR. LaROCK: Objection to the extent
`it mischaracterizes her testimony.
` THE WITNESS: I don't know how many
`there were. I think there were more than two.
` BY MR. SHEA:
` Q. But you can't recall those right
`now?
` A. No. I didn't comment on that or
`review that information.
` Q. Dr. Gilmore, you're testifying on
`behalf of Amneal as a clinical expert; is that
`right?
` A. Yes.
` Q. And a clinical expert as opposed to
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`a formulation expert?
` You understand that difference and
`--
` A. Yes.
` Q. -- make the distinction?
` So what, in your view, is the
`difference between a clinical expert and a
`formulation expert?
` MR. LaROCK: Objection. Outside the
`scope of her declaration.
` THE WITNESS: I can only comment on
`a clinical expert's perspective, given that
`that's my role. And it is to comment on
`treatment of patients with acne.
` BY MR. SHEA:
` Q. So as a clinical expert, you
`wouldn't be able to testify about formulation
`designs?
` A. I would not testify about
`formulation designs.
` Q. You wouldn't -- it wouldn't be
`within your scope of expertise to know how
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`excipients and active ingredients interact?
` MR. LaROCK: Objection. Vague.
` THE WITNESS: Those are not things
`that I have considered.
` BY MR. SHEA:
` Q. And it also wouldn't be within your
`scope of expertise to understand how different
`active ingredients interact with each other --
`with another active ingredient?
` MR. LaROCK: Objection. Vague.
` THE WITNESS: Those aren't things
`that I would be talking about.
` BY MR. SHEA:
` Q. So just hypothetically, if an active
`ingredient concentration was increased, it
`would be outside your scope of expertise to
`know how that influences the final product, the
`final -- the viscosity, the grittiness?
` MR. LaROCK: Objection. Vague.
`Compound. And object to the extent it
`mischaracterizes her declaration.
` THE WITNESS: Can you restate your
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`question.
` BY MR. SHEA:
` Q. Yes.
` So it would be outside your
`expertise, if an active ingredient
`concentration was increased, to understand how
`that would affect the product's -- the final
`product's viscosity?
` MR. LaROCK: Objection. Outside the
`scope of her declaration.
` THE WITNESS: I'm not prepared to
`talk about viscosity of topical formulations.
`I'm here to discuss the clinical use of
`medications in treating acne.
` BY MR. SHEA:
` Q. Sure.
` I mean the viscosity for clinical
`use.
` If you're prescribing a medication,
`you're concerned about the viscosity, correct?
` MR. LaROCK: Objection. Outside the
`scope.
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` THE WITNESS: In prescribing
`medications, I'm not usually talking about or
`using the word "viscosity" with my patients.
` BY MR. SHEA:
` Q. What word would you use?
` A. We talk about efficacy. We talk
`about cost. We talk about application.
` Q. Doctor, I just want to talk to you
`about your prescribing habits and that
`procedure.
` So before the time of the invention,
`you prescribed Aczone; is that correct?
` A. Yes.
` Q. Did you prescribe Aczone for acne?
` A. Yes.
` Q. And again, before the time of the
`invention, did you prescribe it for rosacea?
` A. I don't recall using it for rosacea.
` Q. And be