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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`---------------------------------------X
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA)
`LTD., SHANDONG LUYE PHARMACEUTICAL CO., LTD
`and NANJING LUYE PHARMACEUTICAL CO., LTD,
`
` Petitioners,
`
` v.
`
`ALKERMES PHARMA IRELAND LTD. and ALKERMES
`CONTROLLED THERAPEUTICS, INC.,
`
` Patent owners.
`
` Patent No. 6,667,061 to Ramstack et al.
` Issue Date: December 23, 2003
` Title: PREPARATION OF INJECTABLE
` SUSPENSIONS HAVING IMPROVED
` INJECTABILITY
`Inter Partes Review No. IPR2016-01096
`---------------------------------------X
`Job No. 123496 ** REVISED **
` VIDEOTAPED DEPOSITION OF ROBSON STOREY,
`PhD, taken by Petitioners, held at the
`offices of Fitzpatrick, Cella, Harper &
`Scinto, 1290 Avenue of the Americas, New
`York, New York 10104, on May 3rd, 2016,
`commencing at 10:05 a.m., before Gilbert J.
`Bowles, Notary Public within and for the
`State of New York.
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`TSG Reporting - Worldwide 877-702-9580
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`LUYE1044
`Luye Pharma Group Ltd., et al. v. Alkermes Pharma Ireland Ltd.
`IPR2016-01096
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`---------------------------------------X
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA)
`LTD., SHANDONG LUYE PHARMACEUTICAL CO., LTD
`and NANJING LUYE PHARMACEUTICAL CO., LTD,
`
` Petitioners,
`
` v.
`
`ALKERMES PHARMA IRELAND LTD. and ALKERMES
`CONTROLLED THERAPEUTICS, INC.,
`
` Patent owners.
`
` Patent No. 6,667,061 to Ramstack et al.
` Issue Date: December 23, 2003
` Title: PREPARATION OF INJECTABLE
` SUSPENSIONS HAVING IMPROVED
` INJECTABILITY
`Inter Partes Review No. IPR2016-01096
`---------------------------------------X
`Job No. 123496 ** REVISED **
` VIDEOTAPED DEPOSITION OF ROBSON STOREY,
`PhD, taken by Petitioners, held at the
`offices of Fitzpatrick, Cella, Harper &
`Scinto, 1290 Avenue of the Americas, New
`York, New York 10104, on May 3rd, 2016,
`commencing at 10:05 a.m., before Gilbert J.
`Bowles, Notary Public within and for the
`State of New York.
`
`TSG Reporting - Worldwide 877-702-9580
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`Luye Pharma Group Ltd., et al. v. Alkermes Pharma Ireland Ltd.
`IPR2016-01096
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`A P P E A R A N C E S:
`
` LERNER, DAVID, LITTENBERG, KRUMHOLZ & MENTLIK
` Attorneys for the Petitioners
` 600 South Avenue West
` Westfield, New Jersey 07090
` By: TEDD VAN BUSKIRK, ESQ.
` PAUL KOCHANSKI, ESQ.
`
` FITZPATRICK, CELLA, HARPER & SCINTO
`
` Attorneys for the Patent Owners
` 1290 Avenue of the Americas
` New York, New York 10104
` By: MELINDA ROBERTS, ESQ.
` UNA FAN, ESQ.
`
` PATTERSON BELKNAP WEBB & TYLER
` Attorneys for Licensee to the
` Patent
` 1133 Avenue of the Americas
` New York, New York 10036
` By: DOROTHY LeRAY, ESQ.
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` THE VIDEOGRAPHER: This is DVD
`Number 1 of the video-recorded
`deposition of Robson F. Storey, PhD, in
`the matter of Luye Pharma Group Limited,
`et al, Petitioners versus Alkermes
`Pharma Ireland Limited and Alkermes
`Controlled Therapeutics, Inc., patent
`owners in the United States Patent and
`Trademark Office, before the patent
`trial and Appeal Board. This deposition
`is being held at the Law Offices of
`Fitzpatrick Cella located at 1290 Avenue
`of the Americas, New York, New York on
`May 3rd, 2017 at approximately
`10:05 a.m.
` My name is Rodolfo Duran. I'm the
`Legal Video Specialist. The court
`reporter today is Gilbert Bowles, and
`we're both in association with TSG
`Reporting Inc.
` Will counsel please introduce
`themselves?
` MR. VAN BUSKIRK: Good morning.
`On behalf of the petitioners, Luye
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` R. F. STOREY, Ph.D.
` Pharma Group, I'm Tedd Van Buskirk. To
` my left is Paul Kochanski from the
` Lerner David firm. We also have with us
` Mr. Renjiu Li from Luye Pharma Group.
` MS. ROBERTS: Melinda Roberts from
` Fitzpatrick Cella on behalf of patent
` owner. With me is Ms. Fan also of
` Fitzpatrick Cella on behalf of the
` patent owner.
` Claire Vasios of Alkermes, and
` Dorothy LeRay on behalf of Janssen, a
` licensee to the patent at issue.
` THE VIDEOGRAPHER: Will the court
` reporter please swear in the witness.
`R O B S O N F. S T O R E Y, called as a
`witness, having been first duly sworn by a
`Notary Public of the State of New York, was
`examined and testified as follows:
`EXAMINATION BY
`MR. VAN BUSKIRK:
` Q. Good morning, Dr. Storey.
` A. Good morning.
` Q. How are you?
` A. Fine, thank you.
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`TSG Reporting - Worldwide 877-702-9580
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` R. F. STOREY, Ph.D.
` Q. Good to hear.
` Would you please state your name
`and address for the record.
` A. Robson F. Storey, 111 Holly Drive,
`Hattiesburg, Mississippi 39402.
` Q. Have you given a deposition
`before?
` A. Yes.
` Q. Okay. I'll assume some general
`familiarity with the rules, but just so that
`we have an understanding why don't we go over
`some ground rules.
` You need to speak up and answer my
`questions orally, rather than nods and
`um-hums, okay?
` A. Yes.
` Q. If for any reason you don't
`understand my question, I imagine your
`counsel will say so. But if you don't
`understand, please ask me. It doesn't serve
`us to have you not understand my question or
`answer something that I'm not asking, okay?
` A. Okay.
` Q. You may take a break when you need
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` R. F. STOREY, Ph.D.
`and if you need. But all I would ask is that
`if there is a question pending, you would
`answer my question first before taking any
`break.
` A. I understand.
` Q. Okay. Are you taking any
`medications or drugs or anything that might
`interfere with you giving truthful testimony
`this morning?
` A. No.
` Q. Okay. Is there any reason other
`than that why you wouldn't be able to answer
`my questions truthfully and fully?
` A. No.
` Q. Let's talk about your previous
`deposition experience, if we could.
` MS. ROBERTS: If I could --
` MR. VAN BUSKIRK: Please.
` MS. ROBERTS: -- just
` preliminarily note for the record, we
` haven't actually consented to this
` deposition being videotaped, and the
` notice didn't specify that it would be,
` so we reserve our rights to object to
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` R. F. STOREY, Ph.D.
` any use of this videotape in the hearing
` or otherwise.
` MR. VAN BUSKIRK: Understood. We
` had the same situation with Dr. DeLuca's
` deposition, and I think we'll work it
` out between counsel.
` MS. ROBERTS: I'm sure we will.
` MR. VAN BUSKIRK: But your
` objection is noted. Thank you.
` MS. ROBERTS: Okay.
` Q. How many time haves you been
`deposed before, Dr. Storey, generally?
` A. It's an estimate. Probably 12 to
`15, maybe. Times.
` Q. Is there a -- were you deposed in
`your capacity as an expert witness or as a
`fact witness, if you know?
` A. Always as an expert witness.
` Q. Do those cases fit into any kind
`of a general subject matter; for instance,
`are they patent cases as opposed to something
`else?
` A. Almost all are patent cases. One
`or two product liability cases.
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` Q. Of the patent cases, is there a
`general subject matter to those cases?
` A. I would characterize it as most of
`them have been biomedical related.
` Q. So does biomedical include
`pharmaceuticals?
` A. Yes, it does.
` Q. Okay. Besides pharmaceuticals,
`what kind of subject matter in those
`biomedical cases?
` A. Implants, which would be in the
`area of orthopedics, so I wouldn't consider
`that to be pharmaceutical per se.
` Q. Medical device?
` A. Medical device, correct.
` Yeah, I think that's -- most of
`them have been in that area.
` Q. Most of the cases have been in the
`area?
` A. Most of the cases that I've worked
`as an expert witness have been in the
`biomedical area, which would include
`pharmaceutical and medical devices.
` Q. As between medical devices and
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` R. F. STOREY, Ph.D.
`pharmaceuticals, of the 12 to 15 times as an
`expert, one to two which are product
`liability, so we're somewhere around a dozen,
`would you say, cases that are patent cases?
` A. I think so.
` Q. Okay. What would the rough
`breakdown be of those patent cases between
`pharmaceuticals versus medical devices?
` A. You're testing my memory.
`Probably two-thirds to three-quarter would
`have been pharmaceutical. No, that's not
`true. I wasn't prepare for that question.
` I would say maybe -- let's just
`say half and half.
` Q. Let's focus on the pharmaceutical
`cases now.
` What was the general subject
`matter of those biomedical pharmaceutical
`cases?
` A. Well, two that I recall fairly
`vividly was one involved microspheres of
`the -- you might know it as Lupron Depot,
`that product, and another involved
`drug-eluting coronary stents.
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` R. F. STOREY, Ph.D.
` So that -- that's actually, I
`would say, both. It's both pharmaceutical
`and device.
` Q. Sure, because you've got an
`implanted device delivering an active, right?
` A. Correct.
` Q. All right.
` A. So it fits both.
` Q. Okay.
` A. That was a little bit part of my
`confusion when I was trying to put all that
`together in my head from your previous
`question.
` Q. Okay. Who is the party that you
`were providing expert testimony for in the
`drug-eluting stent case?
` A. That would be the Cordis Division
`of Johnson & Johnson.
` Q. And Lupron Depot were you
`testifying there on behalf of TAP or Takeda?
` A. TAP.
` Q. That's the patent holder there,
`correct?
` A. That is correct.
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` R. F. STOREY, Ph.D.
` Q. Okay. So those are the two
`biomedical pharmaceutical cases that you
`recall vividly?
` A. Correct.
` Q. Do you recall others less than
`vividly?
` A. Yes, because my mind is drawing a
`blank right now on what some of the others
`were.
` Q. I do have your CV here, if that
`would help you, although I don't recall
`whether I --
` A. I don't think that's --
` Q. Okay.
` A. I'm sorry to speak -- I don't
`think that's in my CV.
` Q. Okay. Have you always testified
`or provided expert testimony on behalf of the
`patent owner in those cases?
` A. I can't say that it was always,
`but I'm certain that it's the majority of the
`cases.
` Q. By background you're a polymer
`chemist, correct?
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` R. F. STOREY, Ph.D.
` A. Polymer scientist, polymer
`engineer. All of the above: Polymer
`chemist, polymer scientist, polymer engineer.
` Q. You're not a pharmaceutical
`formulator; is that right?
` A. That is correct. I am not.
` Q. You have degrees in math and
`polymer science -- I'm sorry.
` You have Bachelors degrees in
`Mathematics and Polymer Science from Southern
`Miss, correct?
` A. Correct.
` Q. And those were granted in 1978?
` A. Correct.
` Q. Okay. And you also have a PhD
`also in Polymer Science from the University
`of Akron, 1983, correct?
` A. Correct.
` Q. Is there a Masters degree in
`between there, or did you go directly to your
`PhD?
` A. Direct.
` Q. What was the subject of your PhD
`thesis?
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` A. It dealt with polyisobutylene
`polymers.
` Q. Are those polyisobutylene polymers
`related in any way to or used in injectable
`suspensions?
` A. No. To my knowledge, no.
` Q. Or in injection vehicles of any
`kind?
` A. To my knowledge, no.
` Q. Does it relate to it being the
`subject of your thesis -- are you familiar
`with CMC, Carboxymethyl -- Carboxymethyl
`Cellulose?
` A. I know what it is, yes.
` Q. Does your thesis relate in any way
`CMC?
` A. No.
` Q. How about to other
`viscosity-enhancing agents?
` MS. ROBERTS: Objection to form.
` Q. You can answer, if you understand
`the question.
` A. No, it did not.
` Q. Did your thesis relate to PLGA or
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`Poly Latic-co-Glycolic Acid?
` A. No, it did not.
` Q. Did your thesis relate to
`microparticles or microspheres?
` A. No, it did not.
` Q. And finally, your thesis didn't
`relate to Risperidone?
` A. No.
` Q. So after receiving your PhD from
`the University of Akron, you returned to
`Southern Miss as a professor; is that right?
` A. No.
` Q. It's not.
` When did you join Southern Miss
`as a professor?
` A. In 1983. Fall. In the fall of
`1983.
` Q. And when did you receive the PhD?
` A. 1983, formally. I see your
`confusion.
` Q. Okay. Sure. Let's -- so there's
`a story here.
` A. Well, let me just tell you. I
`completed the requirements for the PhD degree
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`in 1982. I went to work for American
`Cyanamid Company immediately there, but I
`didn't formally receive my PhD degree until
`1983 in the August graduation.
` Q. Okay. So there's this period from
`sometime in 1982 to 1983 that you were at
`American Cyanamid, correct?
` A. Correct.
` Q. Do you recall the -- not the exact
`dates, but the month when you started, the
`month when you finished at American Cyanamid?
` A. I think I was there for
`approximately a year. So I believe I started
`there in September, approximately September
`of '82. And then, of course, I started my
`professorship at Southern Miss in September
`of '83, so it was approximately a year.
` Q. Your title at American Cyanamid
`was research chemist; is that right?
` A. Correct.
` Q. So what were -- general terms,
`what were your responsibilities during that
`year at American Cyanamid?
` A. Well, I had -- I worked in the
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` R. F. STOREY, Ph.D.
`corporate research labs, what they called at
`the time discovery research.
` And when I first arrived there, I
`was assigned a project that the corporate
`labs were doing to support the Ag or
`Agricultural Division of the American
`Cyanamid, and that project dealt with
`controlled release of bovine growth hormone,
`which was used to simulate milk production in
`dairy cows.
` Very near the end of my tenure at
`Cyanamid, I also -- I was switched to a
`different project completely unrelated to
`that one that dealt with coatings, surface
`coatings.
` Q. Surface coating for what?
` A. Could be industrial coatings,
`could be architectural coatings not bio or
`agriculturally related subjects.
` Q. Okay. So you mentioned two
`projects, I believe, the one for the
`Agricultural Division involving bovine growth
`hormone, and then a second unrelated project
`on surface coatings.
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` Are there any other projects that
`were your responsibilities during that year
`at American Cyanamid?
` A. No. Those were the only two.
` Q. What was your role in the
`controlled release bovine growth hormone
`project?
` A. My role was to develop matrix-type
`microspheres that could be used to deliver
`that -- that active.
` Q. Did that matrix-type microparticle
`utilize a polymer?
` A. Yes.
` Q. What polymer were you
`investigating?
` A. PLGA.
` Q. Now, did your work on this PLGA
`microparticle for bovine growth hormone
`involve the vehicle -- withdrawn.
` Did the project involve an
`injection vehicle or an injection suspension
`for delivering the microparticles that you
`were working on?
` A. The project did, but I was not
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`involved in that aspect of the project.
` Q. And thank you, because that was
`the question I meant to ask. Necessarily,
`the project would involve a vehicle.
` Your work did not, though,
`correct?
` A. That is correct.
` Q. So is it safe to say since your
`part of the project did not involve an
`injection vehicle, it also didn't involve CMC
`or a viscosity enhancing agent?
` MS. ROBERTS: Objection to form.
` A. You are correct. I didn't work
`with CMC or injection vehicles at all.
` Q. And the active agent being
`delivered was bovine growth hormone, not some
`other active pharmaceutical ingredient,
`correct?
` A. That is correct.
` Q. So in the fall of 1983, you began
`your professorship, correct?
` A. Correct.
` Q. And you've been with the
`University of Southern Mississippi ever
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`since?
` A. Correct.
` Q. Outside of academia and the work
`that we've talked about at American Cyanamid,
`have you had any additional work experience?
` A. None outside of academia or
`outside of American Cyanamid, no.
` Q. As Ms. Roberts probably told you,
`this isn't meant to be a memory test, so I do
`have your report and your CV if you'd like
`it. But I will ask some questions in a
`general way and see if you can answer them
`that way, first.
` You have a fairly lengthy list of
`publications and lectures. I think a 162
`publications, by my count.
` Does that sound correct?
` A. That sounds about right.
` Q. Which of those 162 publications,
`if any, report on microspheres or
`microparticles?
` A. I don't think any do.
` Q. Would you want to consult your CV
`to confirm, or are you comfortable with that
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`answer?
` A. I'm comfortable with it.
` Q. Which, if any, of those 162
`publications report on injectable
`suspensions?
` A. Zero.
` Q. Same answer with respect to the
`injection of vehicles?
` A. Same answer.
` Q. How about CMC?
` A. Same answer.
` Q. Let's turn to your lectures
`contained in your CV.
` Any of those lectures focus on
`microparticles or microspheres?
` A. None pertain to that.
` Q. I didn't ask this question with
`respect to your publications, but just for
`clarity of the record, if none of your
`publications are microspheres, is it also
`true that none of your publications are PLGA
`microspheres?
` A. Yes, that's also true.
` Q. And is that also the case with
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`respect to your lectures you've presented?
` A. Yes.
` Q. Staying focused on the lectures,
`how about are any on injectable suspensions?
` A. No.
` Q. How about injection vehicles?
` A. No.
` Q. CMC?
` A. No.
` Q. Since the time you joined
`University Southern Mississippi, have you had
`any experience in preparing microparticles to
`be suspended in injection vehicles used for
`parenteral injections?
` A. No.
` Q. Have you ever developed any
`injection vehicles for use in connection with
`injecting microparticles?
` A. No.
` Q. You're also named as inventor of a
`number of patents.
` At least as of the time of your
`report you have 31 issued patents; does that
`sound correct?
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` A. That sounds correct.
` Q. Okay. You probably see where this
`is going, because I'm going to ask you the
`same series of questions about which of those
`patents deal with injectable suspensions.
` A. None.
` Q. Injection vehicles?
` A. None.
` Q. CMC?
` A. None.
` Q. Viscosity enhancing agents?
` A. None.
` Q. Microspheres?
` A. None.
` Q. PLGA microspheres?
` A. None.
` Q. Do you have any experience in
`preparing other pharmaceutical dosage forms?
` MS. ROBERTS: Objection. Form.
` Relevance.
` A. Could you be more specific?
` Q. Aside from the PLGA microparticles
`for delivering bovine growth hormone, have
`you prepared any other pharmaceutical dosage
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`forms in your career?
` A. I think the answer is yes. So let
`me -- I'll try to direct you. We -- in the
`late '90s, we did some work for Depue -- as a
`professor now. This was a sponsored research
`project -- and we were making polymers for
`them. And I believe that they used our
`polymers to make bone putties that might have
`had some sort of active in them or
`potentially have an active in them.
` That is the only thing that I
`could think of. And I think you will find
`them in Patents 9 and 10, if you wish to go
`there.
` Q. I'll take your word for it.
` A. Okay.
` Q. Do you believe that at the time of
`the invention -- let me back up.
` You're familiar with the concept
`that we, the patent attorneys, talk about as
`a POSA, a person of ordinary skill in the
`art?
` A. I'm familiar with the concept.
` Q. Okay. And you know that there is
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`a definition for POSA proposed by both
`parties in this proceeding, correct?
` A. Yes.
` Q. Do you believe that at the time of
`the invention that you were a POSA in the art
`of injectable suspensions for parenteral
`formulations?
` A. At least. I think I was actually
`more skilled than a POSA, I think.
` Q. And do you believe that at the
`time that you mentioned you were a POSA with
`respect to pharmaceutical formulation of
`injectable dosage forms?
` MS. ROBERTS: Objection to form.
` Asked and answered.
` MR. VAN BUSKIRK: I don't think
` it's the same question at all, counsel.
` A. I am not an expert in injection
`vehicles, if that's what you're asking. I
`know generally about them, but I don't
`practice that.
` Q. Going back to the first question I
`asked regarding the POSA, you do believe that
`that you were a POSA at the time of the
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`invention in the art of injectable
`suspensions for parenteral formulations?
` MS. ROBERTS: Objection. Asked
` and answered.
` A. I will stand by that answer. But
`my skill set lies in the issues relating to
`the particles and to the polymers involved,
`not with regard to the formulation of the
`injectable product.
` MR. VAN BUSKIRK: Thank you.
` Q. So with respect to the opinions
`that you are providing for this case, those
`are limited to the petitioner's second
`ground, correct, which is a combination of
`Gustafsson and Ramstack, and the handbook of
`pharmaceutical recipients; is that right?
` A. That is correct.
` Q. Okay. And you're not expressing
`and don't expect to express any opinions
`regarding ground one, which is a different
`set of references, correct?
` A. That is correct.
` Q. And now with respect to ground
`two, the focus of your opinions are on Claims
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`20 and 21, correct?
` MS. ROBERTS: Objection to form.
` Q. Do you understand my question?
` A. I do. The opinions that -- that
`I'm going to give bear most directly on 20
`and 21.
` Q. So that we're not talking about
`this in the abstract, I have a copy of your
`report. It has been previously marked as
`Alkermes Exhibit 2054.
` Do recognize that, Dr. Storey?
` A. Yes.
` Q. You prepared that declaration,
`Dr. Storey?
` A. I didn't hear that.
` Q. Who prepared that declaration?
` A. I did.
` Q. Approximately, how long did it
`take you to prepare that declaration?
` A. Many hours. I don't know exactly
`how many.
` Q. Who did you work with in preparing
`that declaration?
` A. I worked primarily with
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` R. F. STOREY, Ph.D.
`Irena Royzman and Dorothy LeRay.
` Q. Irena Royzman from Patterson
`Belknap?
` A. That is correct.
` Q. Did you work with any counsel from
`Fitzpatrick Cella in preparing your
`declaration?
` A. I don't think I directly worked
`with them. They may have provided input at
`the very end. I'm not sure. But the primary
`task of drafting this was done by myself in
`conversations with Irena Royzman and Dorothy
`LeRay.
` Q. Is Ms. Royzman counsel for
`Alkermes or some other party?
` A. I think -- not Alkermes. I think
`Johnson & Johnson.
` Q. What did you do to prepare for
`your deposition here today?
` MS. ROBERTS: I just want to
` caution the witness to not reveal any
` privileged conversations that we might
` have had.
` Tell him what we did, but not what
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` we specifically discussed.
` A. Let's see. We, with the
`Fitzpatrick law team and with Irena and
`Dorothy present, we had a telephone -- I
`guess you might call it prep or pre-prep
`session on a date I can't recall that lasted
`maybe for an hour or so, maybe a couple of
`hours at the most.
` And then yesterday I discussed, or
`did a prep in the parlance, yesterday at the
`law office here for maybe three-and-a-half,
`four hours.
` Q. When was your telephone prep
`session?
` A. I don't remember the exact date.
`It would have been in mid April, I think.
` Q. So you're generally familiar with
`the -- if I use the term '061 Patent, do you
`understand that to be an Alkermes' patent
`that is the subject of this interparties'
`review?
` A. I do.
` Q. And you've reviewed the patent and
`its claims?
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` A. Yes.
` Q. Okay. Isn't it a fact that
`Claim 1 of the '061 Patent is broad enough to
`cover any microparticle that uses polymeric
`binder?
` MS. ROBERTS: Objection. Form.
` A. If -- could I -- could you read it
`back to me?
` Q. Sure. The question was: Isn't it
`a fact that Claim 1 of the '061 patent is
`broad enough to cover any microparticle that
`uses polymeric binder?
` MS. ROBERTS: Same objection.
` A. Only if the polymeric binder meets
`the definition of the microparticle as
`defined in the '061 Patent.
` Q. The '061 Patent does not relate to
`any specific active ingredient of the
`claim -- of Claim 1, excuse me -- is broad
`enough to cover any active agent, correct?
` A. Could I have the patent?
` Q. Sure could. Good idea.
` So I will hand you what has been
`previously marked as Luye Exhibit 1001. This
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`is U.S. Patent 6,667,061.
` If you want to take a moment to
`pre-orient yourself, please do.
` MS. ROBERTS: In the meantime,
` I'll make an objection to form. You're
` calling for a legal conclusion, and it's
` outside of the scope of this expert's
` declaration. So that was three
` objections.
` A. Okay. I'm ready to hear the
`question again.
` Q. Let me simplify the question, and
`ask this: To your understanding, Claim 1 of
`the '061 Patent does not specify any
`particular active ingredient?
` MS. ROBERTS: Objection. Outside
` of the scope. Form. Relevance.
` Q. Do you understand my question,
`Doctor?
` A. I understand it.
` The patent simply says
`microparticles comprising a polymeric binder.
`The claim doesn't mention a specific agent.
` Q. And PLGA is an example of a
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`polymeric binder according to the '061
`Patent, correct?
` A. Correct.
` Q. Now, previously you testified that
`the focus of your declaration was actually
`Claims 20 and 21, correct?
` A. The p
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