`
` S. Narasimha Murthy, Ph.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` CASE NO. IPR2018-00168
` U.S. PATENT NO. 9,549,938
`
`FLATWING PHARMACEUTICALS, LLC, PETITIONER
`
`VERSUS
`
`ANACOR PHARMACEUTICALS, INC., PATENT OWNER
`**************************************************
` DEPOSITION OF
` S. NARASIMHA MURTHY, PH.D.
`**************************************************
` APPEARANCES NOTED HEREIN
`
` DATE: AUGUST 20, 2018
` PLACE: MAYO MALLETTE PLLC
` 2094 OLD TAYLOR ROAD
` OXFORD, MISSISSIPPI
` TIME: 9:08 A.M.
`
`REPORTED BY: TODD J. DAVIS
` BCR, CSR #1406, RPR
`JOB NUMBER: 146558
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`Anacor Exhibit 2018
`Flatwing Pharmaceuticals, Inc. v. Anacor Pharmaceuticals, Inc
`IPR2018-00168
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` S. Narasimha Murthy, Ph.D.
`APPEARANCES:
`
` PHILIP SEGREST, JR., ESQ.
` Husch Blackwell
` 120 South Riverside Plaza
` Chicago, Illinois 60606
` COUNSEL FOR PETITIONER
`
` AARON MAURER, ESQ.
` ANTHONY SHEH, ESQ.
` Williams & Connolly
` 725 Twelfth Street, NW
` Washington, DC 20005
` COUNSEL FOR PATENT OWNER
`
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`Anacor Exhibit 2018
`Flatwing Pharmaceuticals, Inc. v. Anacor Pharmaceuticals, Inc
`IPR2018-00168
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` S. Narasimha Murthy, Ph.D.
` INDEX
`Style and Appearances ..................... 1
`Index ..................................... 3
`Examination by Mr. Maurer ................. 4
`Certificate of Court Reporter ............. 102
`Certificate of Deponent ................... 103
`
`EXHIBITS:
`Exhibit 1005-A Declaration of Dr. Murthy... 5
`Exhibit 1005-B Declaration of Dr. Murthy... 5
`Exhibit 1005-C Declaration of Dr. Murthy... 5
`Exhibit 1001-C U.S. Patent................. 7
`Exhibit 2008 Journal.................... 79
`Exhibit 2007 Drug Delivery.............. 63
`Exhibit 2009 Article.................... 69
`Exhibit 2004 Article.................... 36
`Exhibit 2002 Transcript................. 13
`Exhibit 2003 Transcript................. 13
`Exhibit 2005 Research Paper............. 47
`Exhibit 2006 Article.................... 49
`Exhibit 1001-A U.S. Patent................. 6
`Exhibit 1001-B U.S. Patent................. 7
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`Anacor Exhibit 2018
`Flatwing Pharmaceuticals, Inc. v. Anacor Pharmaceuticals, Inc
`IPR2018-00168
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` S. Narasimha Murthy, Ph.D.
` S. NARASIMHA MURTHY, PH.D.,
`having been first duly sworn, was examined and
`testified under oath as follows:
`EXAMINATION BY MR. MAURER:
` Q. Okay. Good morning.
` A. Good morning.
` Q. Can you please state your name and
`address?
` A. My name is S. Narasimha Murthy. My
`address is 501 Bowie Drive, Oxford, Mississippi
`38655.
` Q. And you're appearing here today as an
`expert witness on behalf of Flatwing
`Pharmaceuticals; is that correct?
` A. That's correct.
` Q. And you have submitted as an expert four
`declarations and four separate IPRs on Flatwing's
`behalf, correct?
` A. Correct.
` Q. And do you understand that the
`deposition that is being taken here today is a
`combined deposition for each of those four
`proceedings?
` A. Correct. I understand.
`
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`Anacor Exhibit 2018
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`IPR2018-00168
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` S. Narasimha Murthy, Ph.D.
` Q. Okay. I have handed you or put in front
`of you some papers that have been premarked.
`These are the four declarations that you submitted
`in each of those four IPRs --
` MR. MAURER: And, Philip, you have these
` as well.
` (Exhibit 1005-A marked for
` identification.)
` (Exhibit 1005-B marked for
` identification.)
` (Exhibit 1005-C marked for
` identification.)
`BY MR. MAURER:
` Q. And the four patents that are at issue.
`Let me explain that because they have been
`previously marked all with the same -- with
`overlapping numbers, we have taken the liberty of
`assigning them differentiators here.
` So if you look in front of you, you
`will see that your declaration in the
`IPR2018-00168, which is about the 938 patent, is
`marked Exhibit 1005.
` A. Okay. Yeah.
` Q. Okay. The -- your declaration in IPR
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` S. Narasimha Murthy, Ph.D.
`169, which is about the 289 patent, we've marked
`as Exhibit 1005-A.
` A. Uh-huh (affirmative response).
` Q. We marked your declaration in the 0170
`IPR against the 290 patent as Exhibit 1005-B. And
`we've marked your final declaration in IPR 0171,
`which is against the 823 patent, as Exhibit
`1005-C.
` Do you see that?
` A. Yes.
` Q. All right. You've got all those there
`in front of you; and if you ever need to refer to
`them during the course of the day, that's fine.
`You're free to do so.
` A. Yeah.
` Q. Likewise, the patents were marked with
`overlapping numbers in these four different
`proceedings, so we have given them different
`identifiers.
` A. Uh-huh (affirmative response).
` Q. And I placed those in front of you.
` A. Okay.
` (Exhibit 1001-A marked for
` identification.
`
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` S. Narasimha Murthy, Ph.D.
` (Exhibit 1001-B marked for
` identification.)
` (Exhibit 1001-C marked for
` identification.)
`BY MR. MAURER:
` Q. The 938 patent is Exhibit 1001.
` A. Uh-huh (affirmative response).
` Q. And the 289 patent is Exhibit 1001-A.
`The 290 patent is Exhibit 1001-B, and the 823 is
`1001-C.
` A. Okay.
` Q. And if, again, you need to refer to
`those at any point today, you should feel free to
`do so.
` Are you aware that there have
`been --
` MR. SEGREST: Before we get into the
` questioning, I actually thought we were going
` to do appearances on the record, so --
` MR. MAURER: I was going to do that,
` too.
` MR. SEGREST: But that's fine.
` We did have an objection to the notice
` only to the extent that it exceeds the scope
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` S. Narasimha Murthy, Ph.D.
` of cross-examination permitted, and only
` to -- except to note that the parties have
` agreed to allow the use of previous
` depositions in the cases IPR2015-1776, -1780,
` and -1785. But Petitioner notes that the
` parties agreed to allow the use of that
` previous deposition testimony to the extent
` it's relevant on the issues, including
` background of the witness and prior art
` references that are common to those
` proceedings and this one.
` We reserve the right to object to
` testimony that may have been taken in that
` proceeding. It's not relevant to this one.
` It's relating only to the patent in that
` proceeding.
` Petitioner also reserves the right to --
` additionally, Petitioner reserves the right
` to object in this deposition to any
` particular questions, regardless of whether
` similar objections were or could have been
` interposed in that previous deposition.
` MR. MAURER: Anything else?
` MR. SEGREST: No.
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` S. Narasimha Murthy, Ph.D.
` MR. MAURER: Did you want us to put our
` appearances on the record, sir?
` COURT REPORTER: No. I've got them all
` right here.
` MR. MAURER: Okay.
`BY MR. MAURER:
` Q. Are you aware that other IPRs have been
`filed regarding the patents that are marked as
`Exhibit 1001 and A through C by Mylan?
` A. By whom?
` Q. Mylan Pharmaceutical?
` A. No. I'm not aware of it.
` Q. So you've never had any communications
`with representatives of Mylan or counsel for
`Mylan?
` A. No.
` Q. Okay. Let's look, if we could, at --
`and it doesn't really matter which of the
`declarations because they are substantial --
`there's substantial overlap.
` But let's look at, why don't we
`say, 1005, the declaration for the 938 patent.
` A. Okay.
` Q. And I'm going to ask you to turn to
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` S. Narasimha Murthy, Ph.D.
`paragraph 10.
` A. Uh-huh (affirmative response).
` Q. On -- paragraph 10 on Page 3.
` A. Paragraph 10. Sorry.
` Q. It's paragraph 10, not Page 10. Sorry.
` Are you with me?
` A. Uh-huh (affirmative response).
` Q. Because this deposition is being
`recorded stenographically, if you are giving a --
`I'm going to ask you to give a verbal answer, and
`if you're answering affirmative to say "yes"
`instead of uh-huh --
` A. Okay.
` Q. -- or in the negative, "no" instead of
`uh-uh because otherwise it's not clear on the
`transcript. Okay?
` A. Sure.
` Q. Thank you. And in paragraph 10, there's
`a list of materials considered by you in forming
`your opinions; is that right?
` A. Uh-huh (affirmative response). Right.
` Q. Is that yes?
` A. Yes.
` Q. And for the materials -- strike that
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` S. Narasimha Murthy, Ph.D.
`question.
` Did you review any other materials
`in preparing your opinions with respect to these
`patents?
` A. No.
` Q. And if we turn to the last page of
`Exhibit 1005, is that your signature there?
` A. Right.
` Q. And did you read your declarations
`carefully before signing them?
` A. Yes, I did.
` Q. And that's true for all of the
`declarations?
` A. True for all of them.
` Q. And did you see anything that you wanted
`to change in any of your declarations?
` MR. SEGREST: Object to the form.
` A. Well, there are a couple of places where
`we have cited the wrong page number.
`BY MR. SEGREST:
` Q. Okay.
` A. That's the only thing that we -- that I
`noticed.
` Q. Okay.
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` S. Narasimha Murthy, Ph.D.
` A. Otherwise, it's okay.
` Q. Other than the citation errors, those
`page numbers, it's fine?
` A. Yeah.
` Q. If we -- in your report, Exhibit 1005,
`turn to paragraph 23. You have a statement in
`there about the earliest priority date.
` Do you see that?
` A. That's right.
` Q. And is it your understanding that the
`earliest claimed priority date for the 938 patent
`is February 16th, 2005?
` A. That's correct.
` Q. And it's the same priority date for each
`of these patents at issue --
` A. Right.
` Q. -- here, correct?
` A. Correct.
` Q. And that's your understanding as to
`that?
` A. That's right.
` Q. And if I say "priority date" today, you
`will understand that I'm talking about this date,
`correct?
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` S. Narasimha Murthy, Ph.D.
` A. That's right.
` Q. Now, you've testified as an expert
`previously on patents that are related to the ones
`at issue in these IPRs, correct?
` A. Correct.
` Q. And you did that on behalf of the
`Coalition for Affordable Drugs?
` A. Correct.
` Q. In that case you provided declarations
`and deposition testimony. Yes?
` A. Correct.
` MR. MAURER: Let's get Exhibit 2002.
` And 2003. It should be marked already.
` (Exhibit 2002 marked for
` identification.)
` (Exhibit 2003 marked for
` identification.)
`BY MR. MAURER:
` Q. I'm going to mark as Exhibit 2002 a copy
`of the transcript of the proceedings in May of
`2016 that you gave in connection with your work
`for the Coalition for Affordable Drugs.
` A. Okay.
` Q. Do you recall giving that as -- that
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` S. Narasimha Murthy, Ph.D.
`deposition in May --
` MR. SEGREST: Objection under Rule 106.
` I think there's an errata sheet for this, as
` well.
` MR. MAURER: Okay. I'm not sure if we
` have that or not, but we will take note of
` that.
`BY MR. SEGREST:
` Q. So the -- do you recall giving that
`deposition in 2016?
` A. Right.
` Q. And did you review that transcript after
`you gave the deposition?
` A. Yeah, I did.
` Q. And did you find any errors?
` A. There were some errors, and that was
`brought up with the counsel. That was told to the
`counsel.
` Q. And you submitted, then, an errata sheet
`to correct the errors; is that right?
` A. Yeah.
` Q. When did you most recently review this
`transcript, Exhibit 2002?
` MR. SEGREST: Object to form.
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` A. It was about a week ago. I just went
`over -- not really review line by line, but I just
`went over the major things.
`BY MR. MAURER:
` Q. And did you see anything when you
`reviewed it that you wanted to correct?
` A. No.
` Q. I'm going to hand you what's been marked
`as Exhibit 2003. This is a transcript of a
`deposition that you gave in those prior IPRs in
`September of 2016.
` Do you see that?
` A. Correct. Yes.
` Q. Did you testify truthfully during that
`deposition?
` A. Yes.
` MR. SEGREST: Objection under 106 again.
` There is an errata sheet that's on file in
` the previous IPR.
`BY MR. MAURER:
` Q. And you reviewed this transcript after
`you testified; is that correct?
` A. After my deposition, you mean?
` Q. Yes.
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` S. Narasimha Murthy, Ph.D.
` A. No.
` Q. You never, to your --
` A. I never reviewed this after.
` Q. Do you remember filling out an errata
`sheet with respect to this deposition?
` A. Yes.
` Q. And how did you come to complete the
`errata sheet if you didn't review the transcript?
` A. No. I reviewed the transcript.
` Q. Okay.
` A. I told you I reviewed the transcript.
`And I told them there were some errors. But I
`didn't review my declaration, and this is a
`declaration, isn't it?
` Q. No, sir. It should be the transcript.
` A. This is transcript again? Okay.
` Q. Yes. You see that's the transcript from
`the deposition that you gave in September of 2016
`in connection with your work for the Coalition for
`Affordable Drugs?
` A. What is this, then?
` Q. You gave two depositions in that case.
` A. Right. Okay.
` Q. Do you agree?
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` S. Narasimha Murthy, Ph.D.
` A. Yeah. Sure. Sure.
` Q. This is the second one.
` A. Okay. This is the second one. Okay.
` Q. And after you gave that deposition, did
`you review this transcript?
` A. Yeah. I think I did.
` Q. And if you found any errors, did you
`correct them on the errata sheet?
` A. Don't recall.
` Q. When did you most recently review that
`transcript?
` A. Again, same time. A week or ten days
`ago.
` Q. Did you see anything in your review that
`you needed to correct?
` A. I didn't look so closely. I just -- you
`know, it was a high leveled reading. I didn't see
`any -- any mistakes.
` Q. Okay. I'm going to hand you what's
`previously been marked in this -- these
`proceedings as Exhibit 1006. It's a copy of your
`CV.
` Is this a copy of your current
`curriculum vitae?
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` S. Narasimha Murthy, Ph.D.
` MR. SEGREST: Object to the form.
` A. This is my curriculum vitae. That's
`correct.
`BY MR. MAURER:
` Q. When was that last updated?
` A. Well, this is a very old version. This
`is the version that I gave to the counsel quite
`some time ago. I did not update. I mean, I have
`the updated version, but I did not provide them
`that.
` Q. So since Exhibit 1006 has been provided
`in this case, you've updated your CV; is that
`correct?
` A. I have not given them the updated
`version.
` Q. Right. But you have yourself --
` A. I have the updated version.
` Q. And in the -- what is the approximate
`date of Exhibit 1006?
` A. Contrical -- it should be somewhere in
`2016.
` Q. Did you provide an updated curriculum
`vitae to the counsel for Flatwing Pharmaceutical?
` A. No, I did not.
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`IPR2018-00168
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` S. Narasimha Murthy, Ph.D.
` Q. Is this the same -- Exhibit 1006, is
`this the same curriculum vitae that was submitted
`by -- in connection with the Coalition for
`Affordable Drugs papers?
` A. I think so, yeah.
` Q. How would you describe the focus of your
`research?
` MR. SEGREST: Object to the form.
` A. My research is mainly focused on the
`development of topical products for delivery of
`drugs into skin, into nail. Another research
`areas I work on includes intranasal delivery of
`drugs. Mainly -- mainly in the topical products.
`BY MR. MAURER:
` Q. Do you consider yourself an expert in
`the area of development of topical products for
`the delivery of drugs?
` A. That's correct.
` MR. SEGREST: Object to the form.
`BY MR. MAURER:
` Q. Are you familiar with the term the
`"transungual" drug delivery?
` A. Right. I am.
` Q. What does that mean?
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` S. Narasimha Murthy, Ph.D.
` A. It's delivery of drugs into and across
`the nail plate.
` Q. Are you an -- do you consider yourself
`an expert in transungual drug delivery?
` MR. SEGREST: Object to form.
` A. Yes, I am.
`BY MR. MAURER:
` Q. Okay. Have you ever been involved in
`the development of a drug that has made it onto
`the market?
` MR. SEGREST: Object to form.
` A. No.
`BY MR. MAURER:
` Q. You're not a chemist; is that correct?
` A. I am not a chemist.
` Q. No degrees in chemistry?
` A. I have taken quite a few courses in
`chemistry during my [indecipherable] but I do not
`have a degree in chemistry.
` Q. And your work in connection with the
`Coalition for Affordable Drug IPRs provided your
`first exposure to boron chemistry, correct?
` MR. SEGREST: Object to form.
` A. I didn't get the word. What do you mean
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` S. Narasimha Murthy, Ph.D.
`by "boron chemistry"?
`BY MR. MAURER:
` Q. Chemistry involving compounds that have
`boron as a component -- pharmaceutical compounds
`that have boron as a component.
` A. Well, boron compounds are like quite a
`few we use in the pharmaceutical product
`development. But the chemistry part was not
`really -- no. I did not have much exposure to the
`chemistry -- boron chemistry before, yeah.
` Q. You're not a clinician, correct?
` A. I'm not a clinician.
` Q. Which means you've never treated anyone
`with onychomycosis, right?
` A. No.
` Q. What is onychomycosis?
` A. Onychomycosis is fungal infection of the
`nails.
` Q. I want to clarify. I asked you that
`you've never treated anyone with onychomycosis,
`right? And you said no.
` A. No.
` Q. By that, you mean you had not?
` A. I did not treat.
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` S. Narasimha Murthy, Ph.D.
` Q. Have you ever consulted on a particular
`treatment for a patient suffering from
`onychomycosis?
` MR. SEGREST: Object to form.
` A. No.
`BY MR. MAURER:
` Q. Are you a mycologist?
` A. I'm not.
` Q. What's a mycologist?
` A. Mycologist is the one who knows -- who
`has expertise in -- in mycology regarding the
`fungus.
` Q. What is mycology?
` MR. SEGREST: Objection. Foundation.
` A. Science of fungus.
`BY MR. MAURER:
` Q. Have you ever formulated any
`pharmaceutical compounds containing boron?
` A. We formulated quite a few products
`containing boron as a part of our lab exercise.
` Q. Which lab exercise was that?
` A. Well, in pharmaceutics we have the
`laboratory experiments to formulate suppositories
`and certain other dosage forms, the semisolids and
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`such things. So there we have developed the
`boron-containing topical products.
` Q. Have you ever formulated any
`pharmaceutical compound containing boron for
`topical treatment of nail disease?
` A. No.
` Q. What was the compound that you used in
`your lab experiments?
` A. We used sodium borate, borax, boric
`acid.
` Q. Can you describe the structure of the
`nail as it relates to the topical treatment of
`onychomycosis?
` A. Could you repeat the question, please?
` Q. Sure.
` Can you describe the structure of
`the nail as it relates to the topical treatment of
`onychomycosis?
` MR. SEGREST: Objection. Scope and
` foundation.
` A. Question is vague. I want specific
`questions. Can you break it down to simpler,
`please? You know, structure of nail, I don't know
`whether you're asking about the nail plate or
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` S. Narasimha Murthy, Ph.D.
`exactly...
`BY MR. MAURER:
` Q. Why don't we start there.
` What is the nail plate?
` A. The nail plate has three layers: The
`dorsal, middle, and the ventral layer.
` Q. Okay. What is the nail plate?
` A. The nail plate is just a matrix of
`keratin. It's made up of keratinocytes.
` Q. So the nail plate is the -- what we
`would call -- nonscientists would call the nail
`itself?
` A. Nail. That's right.
` Q. Are you familiar with the term "nail
`bed"?
` A. Yes.
` Q. What is the nail bed?
` A. The nail bed is the soft tissue
`underneath the nail plate.
` Q. And in onychomycosis, where is the
`infection located?
` A. Infection is located on the nail plate,
`in the nail bed, and in the nail matrix.
` Q. And when you say nail matrix, what is
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`that?
` A. Nail matrix is more to the proximal side
`of the nail bed.
` Q. And when you say "proximal side of the
`nail bed," you're talking about the underneath of
`the nail?
` A. Underneath of the nail.
` Q. So the side that is closest to -- the
`side between the nail plate and the nail bed?
` MR. SEGREST: Object to form.
` A. No.
`BY MR. MAURER:
` Q. Okay.
` A. Nail matrix is a continuation of the
`nail bed.
` Q. Is it underneath the nail bed, or is it
`on top of the nail bed?
` MR. SEGREST: Objection. Form.
` A. It's actually -- see, the nail grows
`from the nail matrix. It's underneath the nail
`fold, rather.
`BY MR. MAURER:
` Q. And where is the nail fold?
` A. There are lateral nail folds and the
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`proximal nail fold.
` Q. Is the nail fold the portion of the --
`at the base of the nail?
` A. There are lateral nail folds and the
`proximal nail fold.
` Q. So there's a proximal nail fold, which
`is at the bottom, and lateral folds at the sides,
`correct?
` A. Correct. That's right.
` Q. Are you familiar with how onychomycosis
`is diagnosed?
` A. Yes.
` Q. And how is it diagnosed?
` A. Basically, by the appearance of the
`nail, and then also do some culture tests to
`identify the fungus.
` Q. In the case of -- in diagnosis of
`onychomycosis by visual inspection, is the
`clinician able to determine the causative
`pathogen?
` MR. SEGREST: Object to the form and the
` scope.
` A. Not really.
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`BY MR. MAURER:
` Q. Could a clinician -- strike that.
` Are there different types of
`onychomycosis?
` A. There are different ways of classifying
`it. So there's dorsal ungual and lateral ungual,
`and then there is onychomycosis that affects the
`nail bed. So there are different ways of
`classifying. Clinical classifications are
`different.
` Q. Are you familiar with distal and lateral
`subungual --
` A. Right. Yeah.
` Q. -- onychomycosis?
` A. Right. Yeah.
` Q. What is that?
` A. Distal and subungual is more towards the
`front side of the nail plate, and subungual would
`be underneath the nail plate.
` Q. Is there any particular pathogen that's
`associated with this distal and lateral subungual
`onychomycosis?
` MR. SEGREST: Objection to form.
` A. So, generally, onychomycosis is caused
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`by dermatophytes.
`BY MR. MAURER:
` Q. Are there any particular dermatophytes
`that are associated with distal and lateral
`subungual onychomycosis?
` A. T. rubrum is the one, and then
`T. mentagophyte is the other one. There is
`sometimes coexistence of Candida albicans with
`that.
` Q. Are you familiar with superficial white
`onychomycosis?
` MR. SEGREST: Objection to form.
` A. Yeah. You know, there are different
`ways of classifying it, depending on the
`clinical -- depending on the official diagnosis.
`So superficial white onychomycosis is -- it's the
`nail plate, but here with -- it's parts of fungal
`infection.
`BY MR. MAURER:
` Q. Any other types that you're aware of?
` A. No, I'm not.
` Q. Have you heard of proximal subungual
`onychomycosis?
` A. Yeah. Something similar to the distal
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`subungual. A proximal subungual would be more
`localized towards the nail fold.
` Q. What about total dystrophic mycosis?
` A. That's like the whole nail apparatus
`being affected.
` Q. What about minor subungual
`onychomycosis?
` A. Just depending on the severity, they
`call it minor.
` Q. If it's not severe, it's called minor?
` A. It is -- if it's not severe, yes.
` Q. And when you -- what's the difference
`between severe and not severe?
` A. That's a clinical term, you know.
` Q. Based on the depth of the infection in
`the nail plate?
` MR. SEGREST: Objection to scope.
` A. Not clear.
`BY MR. MAURER:
` Q. Do you know?
` A. No, not clear. I'm not clear about
`that.
` Q. Have you formulated a compound for
`topical treatment of onychomycosis?
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` A. Yes, I did.
` Q. And what have you formulated?
` A. Well, we formulated -- "we," I mean my
`group, do a lot of research on transungual
`delivery and development of formulations. So we
`worked on a formulation for the delivery of
`terbinafine. We also worked on the delivery of
`trans -- terconazole by a technical assigned
`process. I worked on a drug called ciclopirox.
`And also we developed some -- we screened
`enhancers for a compound called ER12, the project.
`Project was sponsored by Arnold Therapeutics.
` Q. That was a development candidate for
`clinical compound?
` A. I have no clue. They just asked me to
`screen the enhancers.
` Q. Okay. Are you familiar with the use of
`petroleum jelly in the formulation of topical
`treatments for