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`Page 1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES,
`
`INC.,
`
`Petitioner,
`
`vs.
`
`UNITED THERAPEUTICS CORP.,
`
`Patent Owner.
`
` )
`
`)
`
`)
`
`)
`
`)
`
`IPR NO. 2017-01621
`
`IPR NO. 2017-01622
`
`The videotaped deposition of MAUREEN
`
`DONOVAN, Ph.D., called for examination,
`
`taken
`
`pursuant to the Federal Rules of Civil Procedure
`
`of the United States District Courts pertaining to
`
`the taking of depositions,
`
`taken before Lynn A.
`
`McCauley, CSR No. 84-003268, RPR, a Certified
`
`Shorthand Reporter of
`
`the State of Illinois, at
`
`35 West Wacker Drive, 47th Floor, Chicago, Illinois,
`
`on May 24, 2018, at 9:41 a.m.
`
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 1 of 156
`
`
`
`25
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`Page 2
`
`PRESENT:
`
`WINSTON & STRAWN, LLP
`
`35 West Wacker Drive
`
`Chicago, Illinois 60601
`312-558-5600
`
`BY: KURT A. MATHAS, ESQ.
`
`kmathas@winston.com
`
`Appeared on behalf of Petitioner;
`
`WILSON SONSINI GOODRICH & ROSATI
`
`1700 K Street, NW, Fifth Floor
`
`Washington, D.C. 20006-3817
`202-973-8812
`
`BY: VERONICA S. ASCARRUNZ, ESQ.
`
`vascarrunz@wsgr.com
`
`Appeared on behalf of Patent Owner;
`
`and
`
`FOLEY & LARDNER, LLP
`
`3000 K. Street, N.W., Suite 600
`
`Washington, D.C. 20007
`202-295-4044
`
`BY: NATASHA IYER, ESQ.
`
`niyer@foley.com
`Appeared on behalf of Patent Owner.
`
`ALSO
`
`PRESENT:
`
`MR.
`
`JEREMY MANGAN, Videographer.
`
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 2 of 156
`
`No
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`INDEX
`
`WITNESS:
`
`MAUREEN DONOVAN, Ph.D.
`
`EXAMINATION BY:
`
`MS. ASCARRUNZ
`
`MR. MATHAS
`
`Page 3
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`EXHIBITS:
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`DESCRIPTION
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`800-642-1099
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`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 3 of 156
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`Page 4
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`MAUREEN DONOVAN, Ph.D.
`
`THE VIDEOGRAPHER: We are now on the record.
`
`Today's date is May 24, 2018, and
`
`the time is now 9:41 a.m.
`
`This deposition is taking place at
`
`35 West Wacker Drive, Chicago, Illinois.
`
`The caption of this case is Watson
`
`Laboratories, Inc. versus United Therapeutics.
`
`This case is being held in the U.S.
`
`Patent and Trademark Office before the Patent and
`
`Trial Appeal Board.
`
`Today's witness is Maureen Donovan.
`
`Will attorneys please identify
`
`themselves.
`
`MS. ASCARRUNZ: My name is Veronica Ascarrunz
`
`from the law firm of Wilson Sonsini Goodrich & Rosati
`
`in Washington, D.C.
`
`I'm here representing the patent
`
`owner. With me is my co-counsel from Foley &
`
`Lardner, Natasha Iyer, also in Washington, D.C.
`
`MR. MATHAS: Good morning. Kurt Mathas from
`
`Winston & Strawn on behalf of the petitioner, Watson
`
`Laboratories, Inc. and Dr. Donovan.
`
`And joining me this morning are two
`
`summer associates from our office, Jacob Wilbers and
`
`Joe Anderson.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 4 of 156
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`MAUREEN DONOVAN, Ph.D.
`
`THE VIDEOGRAPHER: Will the court reporter
`
`please swear in the witness.
`
`Page 5
`
`(WHEREUPON,
`
`the witness was
`
`duly sworn.)
`
`MAUREEN DONOVAN, Ph.D.
`
`called as a witness herein, having been first duly
`
`sworn, was examined and testified as follows:
`
`BY MS. ASCARRUNZ:
`
`EXAMINATION
`
`Q.
`
`A.
`
`Q.
`
`Good morning, Dr. Donovan.
`
`Good morning.
`
`You recall your first deposition in
`
`connection with the two IPRs at issue was taken last
`
`month; correct?
`
`A.
`
`Q.
`
`Correct.
`
`And at that deposition you answered my
`
`questions truthfully; correct?
`
`A.
`
`Q.
`
`Yes,
`
`I did.
`
`And have you had an opportunity to review
`
`the transcript from that deposition?
`
`A.
`
`Q
`
`A.
`
`Yes,
`
`I have.
`
`Recently?
`
`Relatively recently, yes.
`
`Are you aware of any incorrect testimony
`Q
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 5 of 156
`
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`Page 6
`
`MAUREEN DONOVAN, Ph.D.
`
`in that deposition?
`
`A.
`
`Q.
`
`No.
`
`And, as with your earlier deposition in
`
`this matter, you understand that you are to answer my
`
`questions truthfully; correct?
`
`A.
`
`Q.
`
`Correct. Yes.
`
`And, as before, please let me know if you
`
`don't understand any of my questions; and if you
`
`answer, I'll assume that you have understood; is that
`
`fair?
`
`A.
`
`Q.
`
`That's fair.
`
`You understand that there are two
`
`proceedings before the Patent -- the Patent and
`
`Trademark Office regarding two separate patents;
`
`correct?
`
`A.
`
`Correct.
`
`MS. ASCARRUNZ: Okay. And since those
`
`weren't read into the caption at the beginning,
`
`just
`
`for the record,
`
`those are case IPR No. 2017-01621 and
`
`case IPR 2017-01622.
`
`And, Kurt, as we did before, can we
`
`agree that this transcript will be used in connection
`
`with both of those proceedings.
`
`MR. MATHAS: We agree.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 6 of 156
`
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`Page 7
`
`MAUREEN DONOVAN, Ph.D.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Dr. Donovan, do you agree with me that
`
`your testimony in connection with both of those two
`
`cases is consistent?
`
`A.
`
`Q.
`
`Yes.
`
`And throughout the deposition today, as
`
`you heard, we'll be using this in connection with the
`
`two different patents.
`
`I will try to make clear when my
`
`questions relate only to one; is that fair?
`
`A.
`
`Q.
`
`That's fine.
`
`And I'll ask that if your answers depend
`
`on which patent we're talking about,
`
`to please also
`
`make that clear?
`
`A.
`
`Q.
`
`Okay. Thanks. Yep.
`
`Thank you.
`
`Have you spoken with anyone besides
`
`counsel in preparing for this deposition?
`
`A.
`
`Q.
`
`A.
`
`No.
`
`Do you know who Christopher Butler is?
`
`I'm aware of a witness in this case who
`
`has been referred to as Mr. Butler.
`
`Q.
`
`Okay. Have you ever spoken with him?
`
`No.
`A.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 7 of 156
`
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`Page 8
`
`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`And you recall that there is a district
`
`court litigation between the two parties concerning
`
`the same patents; correct?
`
`A.
`
`Q.
`
`as well?
`
`A.
`
`Q.
`
`Yes,
`
`I do.
`
`And you were deposed in that proceeding
`
`Yes,
`
`I was.
`
`Have you had the opportunity to review
`
`your deposition from that proceeding recently?
`
`A. Meaning relatively recently.
`
`Q.
`
`Okay. Have you reviewed the patent owner
`
`response filed in connection with these IPRs?
`
`A.
`
`I reviewed something I recall being
`
`titled a patent owner response. There are a number
`
`of patent owner documents that I've seen that I --
`
`you know, if there's a specific question or
`
`something, I don't remember which document is which,
`
`but I think I've seen something titled "The Patent
`
`Owner Response."
`
`Q.
`
`Okay. And have you reviewed a
`
`declaration from a Dr. Aaron Waxman in connection
`
`with the two IPRs?
`
`A.
`
`Not to my recollection.
`
`Have you reviewed a declaration from a
`Q.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 8 of 156
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`Page 9
`
`MAUREEN DONOVAN, Ph.D.
`
`Dr. Richard Delvi
`
`(phonetic)
`
`in connection with the
`
`two declarations?
`
`A.
`
`Q.
`
`Yes, I've reviewed that declaration.
`
`Do you -- so there were two declarations
`
`by Dr. Delvi.
`
`I'm trying to understand which -- do
`
`you know if you've seen one or two of those
`
`declarations?
`
`A.
`
`Q.
`
`I'm not sure.
`
`Okay. Fair enough.
`
`In the course of research in your
`
`professional capacity, do you regularly rely on
`
`research you perform in the European Union Community
`
`Register?
`
`A;
`
`I more typically rely on information
`
`that's available from the FDA being a U.S.-based
`
`organization.
`
`I'm certainly aware of the European
`
`Union and the EMA and their methodologies for drug
`
`approving, and so I would know to go look there if
`
`what I was looking for wasn't currently available as
`
`information at the FDA.
`
`Q.
`
`Okay.
`
`I know at the last deposition we
`
`covered a large volume of materials.
`
`I'm going to
`
`put some of those in front of you, not to sort of
`
`overwhelm you, but just so you have them in front of
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 9 of 156
`
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`Page 10
`
`MAUREEN DONOVAN, Ph.D.
`
`you if you need to reference them at any point, and
`
`you should be familiar with all of them so.
`
`A.
`
`Okay.
`
`MS. ASCARRUNZ: And, for the record,
`
`this
`
`will be Exhibit 1001 from Proceeding 2017-01621,
`
`which is U.S. Patent No. 9,358,240.
`
`And then Exhibit 1001 from IPR
`
`Proceeding 2017-01622. This one is U.S. Patent
`
`No. 9,339,507.
`
`And then Exhibit 1002 from IPR
`
`Proceeding 2017-01621, titled "Expert Declaration of
`
`Maureen D. Donovan Ph.D."
`
`Exhibit 1002 from IPR proceeding
`
`2017-01622, entitled "Expert Declaration of Maureen
`
`D. Donovan Ph.D."
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`So I just want to make sure at the
`
`outset -- and you can take your time to glance
`
`through them -- you're familiar with these four
`
`documents; right?
`
`A.
`
`Q.
`
`I am, yes.
`
`And in your declarations, which are both
`
`Exhibits 1002 there, you refer to combinations 1, 2,
`
`and 3 for the '240 patent; correct?
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 10 of 156
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`Page 11
`
`MAUREEN DONOVAN, Ph.D.
`
`Yes.
`
`And in connection with the '507 patent
`
`A.
`
`Q.
`
`declaration you also rely on Combinations 1, 2, and
`
`3°?
`
`A.
`
`Q.
`
`Yes,
`
`I do.
`
`And in Combination 3 for each of the
`
`proceedings you rely on what you called the EU
`
`Community Register; right?
`
`A.
`
`Q.
`
`Yes.
`
`And in Combination 2 for each of the
`
`proceedings you rely on what you called the
`
`OptiNeb-ir user manual; right?
`
`A.
`
`Q.
`
`That's correct.
`
`And you're also an expert for Watson in
`
`the district court proceeding between the parties
`
`related to these same patents; correct?
`
`A.
`
`Q.
`
`Yes, that's correct.
`
`And in that proceeding you also offered
`
`opinions that the patents at issue here, which are
`
`Exhibits 1001 in front of you, are obvious; right?
`
`A.
`
`Q.
`
`Yes.
`
`And in that proceeding you also offered
`
`opinions based on the OptiNeb device as prior art;
`
`right?
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 11 of 156
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`Page 12
`
`MAUREEN DONOVAN, Ph.D.
`
`A.
`
`I think -- and there's certainly
`
`discussion in that expert report about the OptiNeb
`
`device and some of the generations of OptiNeb.
`
`Q.
`
`Okay. And in that proceeding you also
`
`offered opinions based on the Venta-Neb device;
`
`correct?
`
`A.
`
`Q.
`
`Yes,
`
`I did.
`
`And in your professional experience
`
`before you were engaged by Watson to opine on these
`
`patents, you were not familiar with Ventavis;
`
`correct?
`
`A.
`
`Q.
`
`correct?
`
`Not distinctly, no.
`
`And you were not familiar with OptiNeb;
`
`A.
`
`Again, it was one of a number of devices.
`
`I probably was aware of it, but I didn't have any
`
`specific knowledge of it.
`
`Q.
`
`Okay. And before these proceedings you
`
`never came to be familiar with the features of the
`
`OptiNeb devices; correct?
`
`A.
`
`Q.
`
`Not in detail.
`
`And you've never seen an OptiNeb or a
`
`Venta-Neb device in person; correct?
`
`Not to my recollection.
`A.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 12 of 156
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`Page 13
`
`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`And you were not familiar froma
`
`professional standpoint with treprostinil before
`
`these proceedings; correct?
`
`A.
`
`Not in any specific research oriented
`
`sense.
`
`Q.
`
`And I think you mentioned earlier in
`
`response to one of my questions.
`
`You understand that there were
`
`multiple generations of OptiNeb device; correct?
`
`A.
`
`Q.
`
`Yes,
`
`I do.
`
`And you understand that there the
`
`multiple generations of the Venta-Neb device;
`
`correct?
`
`A.
`
`I guess I'm less familiar with the
`
`generations of Venta-Neb device.
`
`Q.
`
`Okay. And you don't have any specific
`
`knowledge of whether the OptiNeb-ir was a single
`
`device versus having multiple models that were termed
`
`OptiNeb-ir; correct?
`
`A.
`
`Again,
`
`I would -- would need some further
`
`information to try to discern what -- what a brand
`
`name covered at any given time.
`
`Q.
`
`And without seeing that further
`
`information, do you know in the course of your work
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
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`Page 14
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`MAUREEN DONOVAN, Ph.D.
`
`in this proceedings whether that is the case?
`
`A.
`
`Q.
`
`I'm sorry. Can you repeat the question?
`
`Sure. Let me rephrase it.
`
`Without further information do you
`
`have current knowledge of whether the OptiNeb-ir
`
`device encompasses a single device or multiple
`
`models?
`
`A. Well, I think it comes down to what
`
`you -- what -- what I might define as a model
`
`difference and what the designer of that device might
`
`determine to be a -- you know, a change in the
`
`current model or what I might discern to be a simple
`
`change in the current model that the -- a slight
`
`change in the current model that the -- the
`
`manufacturer decided to rename as a -- as a next
`
`generation.
`
`I think knowing what the changes
`
`were from the device from -- from known change to
`
`known change or discernable change to discernable
`
`change,
`
`I think is somewhat up to the person
`
`reviewing the change and the magnitude that that made
`
`a difference.
`
`So I'm -- I'm aware that the
`
`Nebu-Tec company named their devices slightly
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 14 of 156
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`Page 15
`
`MAUREEN DONOVAN, Ph.D.
`
`differently.
`
`Each of those devices has different
`
`capabilities.
`
`What's really a model change or
`
`whatever,
`
`I -- I would need more information and
`
`probably a -- I -- I may or may not reserve my own
`
`opinion on whether that was really deserving of a
`
`model change or not.
`
`Q.
`
`Are you aware of model numbers used by
`
`Nebu-Tec in connection with the OptiNeb-ir
`
`designation?
`
`A.
`
`Not specific model numbers without, you
`
`know,
`
`some sort of context for reference.
`
`Q.
`
`Okay. You reviewed and relied to some
`
`extent on the prosecution histories for these two
`
`patents in connection with your opinions; correct?
`
`A.
`
`Q.
`
`Yes,
`
`I did.
`
`And you are aware that during prosecution
`
`of the patents the examiner considered the Chaudry
`
`reference you rely on; correct?
`
`A.
`
`Q.
`
`Yes.
`
`And you are aware that during prosecution
`
`of the patents the examiner considered the Venta-Neb
`
`device and Ventavis; correct?
`
`MR. MATHAS: Object to the form.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 15 of 156
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`Page 16
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`MAUREEN DONOVAN, Ph.D.
`
`BY THE WITNESS:
`
`A.
`
`It's been quite awhile since I've
`
`reviewed the file history.
`
`I -- I just -- I don't
`
`remember.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay.
`
`So is it fair to say you also
`
`don't remember whether the examiner actually cited
`
`this art against the applications during prosecution?
`
`A.
`
`I guess I'd like to refer to the section
`
`where the examiner made comments about that art to
`
`refresh my memory.
`
`Q.
`
`Okay. Did you take into consideration in
`
`forming your opinions what the examiner stated in
`
`connection with certain prior art references?
`
`A.
`
`Oh, I certainly -- when I read the file
`
`histories, I certainly take into account what the
`
`examiner viewed, but the file histories represent a
`
`relatively reasonably long period of time with
`
`changes and so forth.
`
`I -- there were other things
`
`probably that the examiner had in front of them that
`
`aren't necessarily directly part of the file history
`
`so -- so, yeah, I certainly consider the comments of
`
`the examiner, but they're performing a job in a way
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 16 of 156
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`Page 17
`
`MAUREEN DONOVAN, Ph.D.
`
`that I'm unfamiliar with really what -- what the
`
`progress of that evaluation is, so I can't always say
`
`that at any given -- on any given page that what the
`
`examiner was determining at the time stays with me or
`
`really significantly informed my opinion.
`
`Q.
`
`Okay. Are ultrasonic nebulizers
`
`preferable to the air jet nebulizers?
`
`A.
`
`They're a different type of nebulizer.
`
`The ultrasonic nebulizer has its own
`
`attributes that a jet nebulizer doesn't.
`
`There are aspects of jet nebulizers
`
`that are distinct to what ultrasonic nebulizers are
`
`capable of.
`
`So each one has some attributes,
`
`each has drawbacks.
`
`There are -- there would be reasons
`
`why one would select an ultrasonic nebulizer. There
`
`would be reasons now post -- or now that there are
`
`availabilities of other types of nebulizers to select
`
`those.
`
`It's very much a -- a -- it's a
`
`Situational evaluation of whether one might be
`
`considered better than the other for a particular
`
`application.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 17 of 156
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`Page 18
`
`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`And in 2006 were ultrasonic nebulizers
`
`preferable to air jet nebulizers?
`
`A.
`
`Again,
`
`I don't think that anybody would
`
`ever in a generalizable fashion say that they were
`
`always preferable over jet nebulizers.
`
`They had
`
`specific attributes to them. Many -- the portability
`
`of ultrasonic nebulizers compared to the portability
`
`of many of the jet nebulizers was a significant
`
`attribute, and patients appreciated that.
`
`So there are times where if one
`
`could use an ultrasonic nebulizer, you'd select that
`
`just because you knew that your patient population
`
`would like the opportunity to have something that's
`
`slightly smaller and more portable to carry with
`
`them. But that wouldn't always -- it doesn't mean
`
`that it's always better.
`
`Q.
`
`So based on your responses, is it fair to
`
`say that there would be times when jet nebulizers
`
`would be preferable over ultrasonic nebulizers under
`
`certain circumstances?
`
`A.
`
`You know, it varied dependent on the
`
`circumstance which -- how you'd evaluate which
`
`nebulizer to select based on what performance
`
`criteria you desired.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 18 of 156
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`Page 19
`
`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`But you're unwilling to say that
`
`ultrasonic nebulizers in 2006 were universally
`
`preferable to jet nebulizers?
`
`A.
`
`I think there --
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I think there may be under certain
`
`criteria that nearly everybody would select a
`
`ultrasonic nebulizer.
`
`So if your criteria was based on
`
`portability, for example,
`
`I think in 2006 probably
`
`everybody would recognize that an ultrasonic
`
`nebulizer was -- was slightly smaller and more
`
`portable.
`
`It also was subject to more
`
`readily -- or it was more readily damaged by having
`
`it be portable, so there were some -- even some
`
`drawbacks with that.
`
`But, you know,
`
`I don't think that
`
`there was a lot of controversy on that portion of the
`
`functionality.
`
`But a number of the other aspects
`
`and, again, costs and ability to -- or the resistance
`
`to -- to mishap may have overweighed the portability
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 19 of 156
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`Page 20
`
`MAUREEN DONOVAN, Ph.D.
`
`for a particular use.
`
`Q.
`
`I'm sorry. What do you mean by
`
`resistance to mishap?
`
`A. Well, knocking it off of a table and not
`
`have -- and having to immediately replace it because
`
`it no longer worked.
`
`Q.
`
`In addition to portability, are there
`
`other considerations that would inform the selection
`
`of a jet versus ultrasonic nebulizer?
`
`A.
`
`I mean certainly there are other
`
`considerations, but we very quickly get into
`
`considering -- you need to know something about
`
`the -- why you're either considering comparing those
`
`two, what -- what is your intended purpose, what are
`
`your -- what are your goals for comparing them.
`
`So it's really hard just in the
`
`abstract to -- to say, well -- it's easy in the
`
`abstract to say, yes, you would compare them, but how
`
`you would compare them outside of a specific reason
`
`for comparing them is very difficult to do.
`
`Q.
`
`Okay. Nevertheless I'm going to ask you
`
`some questions --
`
`A.
`
`Okay.
`
`Q.
`-- trying to compare them.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 20 of 156
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`Page 21
`
`MAUREEN DONOVAN, Ph.D.
`
`Do ultrasonic nebulizers and air jet
`
`nebulizers differ in connection with considering
`
`output rate?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A. Well,
`
`they have different design
`
`specifications, and so in the world of jet nebulizers
`
`there's probably a range of outputs.
`
`It may be very
`
`different if you -- that range may be narrowed for
`
`pharmaceutical nebulizers compared to other reasons
`
`you'd use a jet compressed air what was -- what is
`
`essentially a nebulizer.
`
`Same thing for ultrasonic
`
`nebulizers.
`
`So if you -- actually reask the
`
`question, and let me see if I can get to a more -- a
`
`more defined answer.
`
`Q.
`
`Sure.
`
`So the question was:
`
`Do ultrasonic
`
`nebulizers and air jet nebulizers differ in
`
`connection with considering output rate?
`
`MR. MATHAS:
`
`Same objection.
`
`BY THE WITNESS:
`
`A.
`
`Yeah, again, I -- it's so dependent on
`
`their -- the design of the actual system and the
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 21 of 156
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`MAUREEN DONOVAN, Ph.D.
`
`intended purpose for designing the system that
`
`they're pretty broad ranges that cover both of them
`
`Page 22
`
`regarding output rates.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Are there differences in how ultrasonic
`
`nebulizers and air jet nebulizers affect particle
`
`size?
`
`A. Well,
`
`they accomplish forming particles
`
`or droplets in different ways, so they -- like --
`
`they -- as far as nebulizers and ultrasonic -- or as
`
`far as jet nebulizers and ultrasonic nebulizers used
`
`for pulmonary inhalation, there's a particular size
`
`range that is oftentimes a goal to achieve, and so
`
`the -- those pieces of -- or those devices are
`
`intentionally designed to maximize the droplet size
`
`in the range that's deemed to be beneficial for
`
`pulmonary delivery.
`
`Whether they -- what the -- what the
`
`dist -- particle size distribution looks like and so
`
`forth around those is somewhat dependant on the
`
`actual type of nebulizer and how it was designed, so
`
`they -- they -- they differ in how each of them forms
`
`the droplets, so,
`
`therefore,
`
`there are different
`
`characteristics of those droplet particle size
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 22 of 156
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`Page 23
`
`MAUREEN DONOVAN, Ph.D.
`
`distributions that's observed between them.
`
`Q.
`
`Are you aware of any difficulties
`
`ultrasonic nebulizers face in aerosolizing certain
`
`types of formulations?
`
`A.
`
`Yes,
`
`I am aware of situations where it
`
`would be less likely for the particle size -- the
`
`desired particle size or droplet size to be emitted
`
`from an ultrasonic nebulizer. Similar to there are
`
`different -- there are other situations where fluids
`
`used in jet nebulizers that I would anticipate they
`
`would have -- they would be more challenging
`
`potentially to be able to develop into the desired
`
`particle size range from -- for a pharmaceutical use.
`
`Q.
`
`Are you aware of any situations with
`
`those challenges that are specific to ultrasonic
`
`nebulizers versus jet nebulizers?
`
`A.
`
`I've been aware of them at times because
`
`I lecture on the differences.
`
`I just can't bring to
`
`mind what the specific differences are at this
`
`moment .
`
`Q.
`
`Okay.
`
`In your opinion is pulse
`
`nebulization preferable to continuous nebulization?
`
`A.
`
`Again, it depends on the use.
`
`It depends
`
`In -- I think in many situations the --
`on the user.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 23 of 156
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`Page 24
`
`MAUREEN DONOVAN, Ph.D.
`
`the ability not to have a -- a wasting of the aerosol
`
`being continuously produced to the environment or
`
`needing to add additional tubing or aspects to the
`
`device to capture that and redirect it back to the --
`
`the -- the filled volume for nebulization is -- is
`
`certainly of benefit.
`
`So you need -- you need to do more
`
`things to capture an aerosol.
`
`So if you -- than if
`
`you didn't have that aerosol being formed
`
`continuously.
`
`So there are certainly -- there are
`
`certainly advantages both from a -- a device and
`
`environmental standpoint for having a -- a device
`
`that emits the desired aerosol when -- when you want
`
`it to and doesn't emit it when you're not able to use
`
`it.
`
`Q.
`
`And in your opinion -- in -- it's your
`
`opinion that continuous nebulization is never
`
`preferable to pulsed nebulization; correct?
`
`MR. MATHAS: Object to form.
`
`BY THE WITNESS:
`
`A.
`
`Yeah,
`
`I don't think it was never
`
`preferable.
`
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 24 of 156
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`Page 25
`
`MAUREEN DONOVAN, Ph.D.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`In your opinion having a patient
`
`coordinate its breathing to the output and timing of
`
`a device is preferable to breath-actuated devices;
`
`right?
`
`A.
`
`I don't know that I've ever expressed
`
`that opinion either,
`
`that -- there are virtues of
`
`both.
`
`The design aspects of one are different than
`
`the design aspects of the other, so they certainly
`
`contribute to cost and so forth, but being able to
`
`assure that the patient -- for a nebulizer, for
`
`example, being able to assure that the patient
`
`inhales the medication when the device is delivering
`
`the medication is the essential portion.
`
`MS. ASCARRUNZ: Okay.
`
`I'm going to hand you
`
`another exhibit. And, for the record,
`
`this is
`
`Exhibit No. 1006 in both proceedings.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`And I see you're flipping through it, so
`
`I'll give you my question so you can keep it in mind
`
`when you flip.
`
`Do you recognize this exhibit?
`
`A.
`
`Yes,
`
`I do.
`
`What is it?
`Q.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 25 of 156
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`Page 26
`
`MAUREEN DONOVAN, Ph.D.
`
`A.
`
`This is a -- I believe this is a
`
`translation -- yes. This is a translation of the
`
`OptiNeb-ir operating instructions.
`
`Q.
`
`Is this the reference you rely on for
`
`your Combination 2 as the OptiNeb-ir user manual?
`
`A.
`
`Q.
`
`Yes, it is.
`
`Did you locate this reference, or was it
`
`provided to you by counsel?
`
`A.
`
`The -- the translation was provided to me
`
`by counsel.
`
`Q.
`
`And was the original German version
`
`located by you, or was it provided to you by counsel?
`
`A.
`
`Q.
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`That was also provided by counsel.
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`You offer opinions about what this manual
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`teaches a POSA; correct?
`
`A.
`
`Q.
`
`Yes,
`
`I do.
`
`So I understand that, but my question --
`
`and my question is going to be are -- but you're not
`
`offering an expert opinion that this exhibit
`
`qualifies as prior art under the law; correct?
`
`A.
`
`I don't know that I'm able to make that
`
`determination, but I am aware that -- that this
`
`device was available at the time that we're speaking,
`
`usually 2004, 2006 type dating; and so the device
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 26 of 156
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`Page 27
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`MAUREEN DONOVAN, Ph.D.
`
`was -- the device -- the OptiNeb device was being
`
`used.
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`I know that the Nebu-Tec company was selling
`
`that device, was interested in having pharmaceutical
`
`companies and individuals use their devices; and so
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`being able to obtain the user manual for a device
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`that was commercially for sale, whether it was --
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`whether I accessed it, whether somebody accessed it,
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`I didn't look for it in 2004, but it would have been
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`easily obtainable.
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`MS. ASCARRUNZ: Okay. That wasn't my
`
`question.
`
`And I move to strike it as not
`
`responsive.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Dr. Donovan,
`
`in your declarations do you
`
`offer an expert opinion that the OptiNeb user manual
`
`meetings the legal requirements of public
`
`accessibility?
`
`A. Well,
`
`in my opinion on Page -- or
`
`Paragraph 55 I believe --
`
`Q. Which document are you looking at?
`
`A.
`
`Oh, I'm sorry.
`
`I'm looking at my expert
`
`declaration in the '507 case.
`
`So in Paragraph 55 I describe how
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2108
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 27 of 156
`
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`Page 28
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`MAUREEN DONOVAN, Ph.D.
`
`the -- the OptiNeb device is described in an abstract
`
`available publicly in the fall of 2000 -- and was
`
`presented in the fall of 2004 by a group of
`
`investigators, and then later in Paragraph 61 I
`
`describe that the OptiNeb device was detailed on the
`
`Nebu-Tec website by at least 2003 referring to a --
`
`probably the same exhibit, different exhibit number,
`
`and I use the information provided to me by other
`
`witnesses who are able to assure that that
`
`information was available in that website in 2003.
`
`Q.
`
`So your answer to the question I asked
`
`is, yes,
`
`in your declarations you offer an expert
`
`opinion that the OptiNeb user manual meets the legal
`
`requirements of public accessibility?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I mean there are -- there are
`
`descriptions in my expert declaration t