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`Page 101
`
`MAUREEN DONOVAN , Ph . D .
`
`of pulmonary delivery in particular,
`
`reproducibility was certainly important, and
`
`there's always a question about even what‘s --
`
`what amount of drug emitted from any device
`
`what amount of that gets to the lungs. There's
`
`loss between the device,
`
`the mouth, and then
`
`subsequently the lungs, and many accept that
`
`the ability to accurately know the exact amount
`
`that got
`
`to the lungs is not something that we
`
`use to evaluate or derive dosing strategies or
`
`evaluate the particular system.
`
`It's the that
`
`it was presented in a fashion that it could
`
`have delivered the same amount each time the
`
`device was used.
`
`Q.
`
`Is there a teaching in Patton
`
`on how long a patient needs to inhale after
`
`they know that the bolus of medicine is ready
`
`for inhalation?
`
`A.
`
`My recollection is Patton
`
`doesn‘t describe the time, but the device is
`
`designed to contain -- the aerosol is emitted
`
`into a volume that is a volume that a typical
`
`user would be able to inhale under their use
`
`
`
`It's
`conditions with a single inhalation.
`
`
`800-642-1099
`
`A Veritext Company
`
`ww.veritext.com
`
`David Feldman Worldwide
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-0162‘I
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`Page101of201
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`Page 102
`
`MAUREEN DONOVAN, Ph.D.
`
`based on lung volume,
`
`in essence, but if for
`
`some patient it -- they weren't able to inhale
`
`that volume,
`
`that the opportunity to follow up
`
`with another breath is certainly part of the
`
`device design based on the valve system.
`
`The speed with which the
`
`person inhales, yOu know, how fast they inhale,
`
`whatever isn‘t described, and this device is
`
`intended to potentially even limit some the
`
`needs to specify those additional requirements
`
`that were known as part of other devices at the
`
`time.
`
`Q.
`
`Does Patton disclose an
`
`ultrasonic nebulizer?
`
`A.
`
`It's not my recollection that
`
`Patton included ultrasonic nebulizers.
`
`It's
`
`certainly in his initial summary of the
`
`invention he describes using a predetermined
`
`volume of gas usually air as the material that
`
`aerosolizes the drug-containing formulation,
`
`but later in the patent I know that there is
`
`other discussion of other ways to accomplish
`
`some of the workings of the invention he is
`
`
`
`describing, and I just don't remember among all
`
`
`800-642-1099
`
`A Veritext Company
`
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`PageIOZof201
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`Page 103
`
`MAUREEN DONOVAN , Ph . D .
`
`of the possible alternatives and directional
`
`changes and so forth whether he opens or openly
`
`describes that this might be further modified
`
`for use with an ultrasonic system.
`
`Q.
`
`Okay. My question might have
`
`been too broad to be fair.
`
`So why don't we do
`
`it this way.
`
`If you could —— if I could
`
`direct your attention to paragraph 90 of your
`
`declaration.
`
`You state there that:
`
`"Patton
`
`teaches a system that generates aerosol using
`
`gas; i.e., a jet nebulizer."
`
`So do you understand Patton to
`
`be discussing the use of a jet nebulizer?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Well,
`
`in the same way a jet
`
`nebulizer uses a gas to form the aerosol that‘s
`
`intended to be inhaled, Patton also primarily
`
`describes the formation of an aerosol brought
`
`forth by a volume of gas, usually a compressed
`
`gas.
`
`So there -- that's where they are
`
`similar.
`
`
`
`The methodologies that
`
`
`800-642-1099
`
`A Veritext Company
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`ww.veritext.com
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`PageIOSof201
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`Page 104
`
`MAUREEN DONOVAN , Ph . D .
`
`traditional jet nebulizers use to form aerosols
`
`are not
`
`the same methodologies that Patton's
`
`description uses to form the aerosol.
`
`Q.
`
`I
`
`am not sure I understand.
`
`So are you saying that Patton
`
`does not teach the use of a jet nebulizer?
`
`A.
`
`No,
`
`I
`
`am saying that both jet
`
`nebulizers and Patton's invention description
`
`describe using a gas,
`
`typically a compressed
`
`gas to form the aerosol. That's their
`
`similarity.
`
`The mechanism by which a jet
`
`nebulizer -— the traditional jet nebulizers
`
`form that aerosol is different than the
`
`mechanism by which the aerosol is formed by the
`
`gas described in the invention described in
`
`Patton.
`
`Q.
`
`Got it. Okay. And neither a
`
`traditional jet nebulizer or the device that's
`
`taught in Patton is an ultrasonic nebulizer,
`
`correct?
`
`A.
`
`As described in this paragraph
`
`what I mean by jet nebulizer, no,
`
`there's not
`
`an ultrasonic source, a sound source that‘s
`
`
`
`forming the aerosol, nor in most of the
`
`
`800-642-1099
`
`A Veritext Company
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`UNITED THERAPEUTICS, EX. 2034
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`Page 105
`
`MAUREEN DONOVAN, Ph.D.
`
`description in Patton does he describe using an
`
`ultrasonic power or an ultrasonic energy source
`
`to form the aerosol.
`
`Q.
`
`You said most of the
`
`description in Patton does not describe using
`
`an ultrasonic power energy source.
`
`Is there any discussion in
`
`Patton that does talk about ultrasonic power?
`
`A.
`
`Again,
`
`I don't recall all of
`
`the details regarding other aspects of the
`
`invention.
`
`So I just don't know whether the
`
`word ultrasonic or ultrasound appears anywhere
`
`in the patent document, but it's certainly not
`
`the original design of the invention that‘s
`
`being described primarily in the document.
`
`Q.
`
`So we have been going 21
`
`minutes since we last talked about breaking.
`
`Is this a good time to break?
`
`A.
`
`It's a good time for me.
`
`THE VIDEOGRAPHER: Going off the
`
`record.
`
`The time is 12:17 p.m.
`
`(WHEREUPON, a recess was had at
`
`12:17 p.m. until 1:23 p.m.)
`
`
`
`THE VIDEOGRAPHER: Going on the
`
`
`800-642-1099
`
`A Veritext Company
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`Page1050f201
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`Page 106
`
`MAUREEN DONOVAN, Ph.D.
`
`record. This marks the beginning of media
`
`number 3.
`
`The time is now 1:23 p.m.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Dr. Donovan, when we were
`
`discussing Patton,
`
`I
`
`think we talked about
`
`the
`
`use of a compressor, correct?
`
`A.
`
`We were talking about
`
`compressed air and jets, yes.
`
`Q.
`
`Okay. And it's your opinion
`
`that Patton teaches the use of a light and
`
`sound that is -— that meets the claim
`
`limitation for an opto-acoustical trigger,
`
`correct?
`
`A.
`
`Well, it has a light device, a
`
`sound device that signals the user.
`
`So, yes,
`
`it's an opto—acoustic device.
`
`Q.
`
`Okay. And do you consider it
`
`to be an opto-acoustical trigger?
`
`A.
`
`Well, it's a device that has a
`
`light and a sound.
`
`They have a meaning to the
`
`user based on the instructions, and so if you
`
`want to call that an opto-acoustic trigger, it
`
`can be viewed as an opto-acoustic trigger under
`
`
`
`that set of conditions.
`
`
`800-642-1099
`
`A Veritext Company
`
`www.veritext.com
`
`David Feldman Worldwide
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`UNITED THERAPEUTICS, EX. 2034
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`
`Page1060f201
`
`
`
`
`
`Page 107
`
`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`Okay.
`
`I will come back to
`
`that.
`
`The light and the sound comes
`
`on immediately after the operation of the
`
`compressor ceases, correct?
`
`yes.
`
`A.
`
`Q.
`
`That's how it's described,
`
`You agree with me that all of
`
`the claims of both patents require an
`
`opto-acoustical trigger, right?
`
`A.
`
`Well, based in the description
`
`in claim 1 that describes a pulsed ultrasonic
`
`nebulizer that aerosolizes -- oh, next one
`
`second
`
`sorry.
`
`THE COURT REPORTER: Wait,
`
`I'm
`
`BY THE WITNESS:
`
`A.
`
`I'm sorry.
`
`Said pulsed
`
`ultrasonic nebulizer comprising an
`
`opto-acoustic trigger as stated in claim 1 of
`
`both patents, and the fact that all of the rest
`
`of the claims are dependent
`
`to claim 1,
`
`there‘s
`
`a requirement for an opto-acoustic trigger.
`
`Ibbdl'OH
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`800-642-1099
`
`A Veritext Company
`
`www.veritext.com
`
`David F eldman Worldwide
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-0162‘I
`
`PageIOYOf201
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`Page 108
`
`MAUREEN DONOVAN, Ph.D.
`
`BY MS.
`
`ASCARRUNZ:
`
`Q.
`
`Okay. And that applies to
`
`both patents, correct?
`
`A.
`
`It's my interpretation because
`
`of the dependency of the rest of the claims,
`
`yes.
`
`Q.
`
`Do you agree with me that the
`
`word trigger must itself mean something in the
`
`claims?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I don't think so.
`
`I don't
`
`recall in the specification where trigger is
`
`specifically defined in the terminology of the
`
`patent writer.
`
`BY MS.
`
`ASCARRUNZ:
`
`Q.
`
`Okay.
`
`So let me ask it this
`
`way.
`
`Let's look at the '50? patent,
`
`and you see that claim 1 claims a kit for
`
`treating pulmonary hypertension comprising, and
`
`then has several paragraphs following?
`
`A.
`
`Okay.
`
`
`
`The section labeled Romanette
`Q.
`
`
`800-642-1099
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`
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`Page 109
`
`MAUREEN DONOVAN , Ph . D .
`
`ii reads:
`
`"A pulsed ultrasonic nebulizer
`
`comprising an opto-acoustical trigger."
`
`Do you agree with me that
`
`claim 1 and,
`
`therefore, all claims of this
`
`patent by dependency require a pulsed
`
`ultrasonic nebulizer comprising an
`
`opto-acoustical trigger?
`
`A.
`
`I agree that that's what‘s
`
`stated in claim 1, Roman Numeral II.
`
`Q.
`
`The word trigger in that claim
`
`language, what does that mean to a person of
`
`ordinary skill in the art?
`
`A.
`
`I
`
`think the best synonym for
`
`that for a POSA would be the word indicator.
`
`Q.
`
`And it's your opinion that
`
`Patton expressly teaches the need and function
`
`of an opto-acoustical trigger, right?
`
`A.
`
`Well, Patton describes the
`
`usage of an opto-acoustic indicator in the
`
`device that he has designed as a way of
`
`demonstrating that the aerosol containing the
`
`medicament has been placed into the chamber.
`
`Q.
`
`The word trigger doesn't carry
`
`
`
`a specific -- it's not a term of art that‘s
`
`
`800-642-1099
`
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`
`
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`Page 110
`
`MAUREEN DONOVAN, Ph.D.
`
`used in the art of inhalation therapies,
`
`correc
`
`t?
`
`A.
`
`Not in the art that I am most
`
`familiar, no.
`
`Q.
`
`Okay. And it's yOur opinion
`
`that,
`
`as used in the claims,
`
`the word trigger
`
`is synonymous with indicator?
`
`A.
`
`That's the way —— that's the
`
`synonym I use for that word, and I anticipate a
`
`number
`
`of other POSAs would use that term also
`
`or use
`
`that synonym also.
`
`Q.
`
`So in your opinion is any
`
`signal
`
`that would demonstrate to the patient
`
`that a
`
`inhale
`
`claims?
`
`device is ready for the patient to
`
`is a trigger within the meaning of the
`
`MR. MATHAS: Object to the form.
`
`BY THE
`
`WITNESS:
`
`A.
`
`That can either -- restate
`
`that.
`
`I am going to have to ask you to break
`
`that down.
`
`BY MS.
`
`ASCARRUNZ:
`
`Q.
`
`Okay.
`
`In your opinion is a --
`
`
`
`is an indicator that demonstrates to the
`
`
`800-642-1099
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`Page 111
`
`MAUREEN DONOVAN , Ph . D .
`
`patient that a device is ready for the patient
`
`to inhale is a trigger within the meaning of
`
`the claims?
`
`MR. MATHAS:
`
`Same objection.
`
`BY THE WITNESS:
`
`A.
`
`Well,
`
`I
`
`think, as I stated,
`
`when I read the descriptor for Roman Numeral
`
`II, my interpretation of the meaning of that is
`
`I could substitute the word indicator for
`
`trigger. That that was the intended meaning
`
`and no further meaning implied to some term the
`
`word used trigger.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay.
`
`Since we were focusing
`
`on the ‘507 patent, can I ask is it also your
`
`opinion with respect to the word trigger in the
`
`'240 patent that you cOuld substitute the word
`
`trigger for indicator and that would cover the
`
`intended meaning of the word?
`
`A.
`
`The phrase in the '240 patent
`
`is different than the phrase in the '507.
`
`So
`
`in this case said pulsed ultrasonic nebulizer
`
`comprising an opto-acoustic trigger which
`
`
`
`allows said human to Synchronize each breath to
`
`
`800-642-1099
`
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`PageI11 0f201
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`Page 112
`
`MAUREEN DONOVAN , Ph . D .
`
`each pulse, and in the case of this phrase
`
`within this claim, yes, as a POSA, my equal
`
`interpretation to the word trigger is
`
`indicator.
`
`Q.
`
`Okay.
`
`In paragraph 125 of
`
`your
`
`'240 declaration, you state that:
`
`"A POSA
`
`would be motivated to combine Voswinckel's
`
`teaching of a therapeutically efficacious
`
`treatment using a pulse nebulizer with Patton's
`
`teachings on reliability, precision, and
`
`efficiency."
`
`A.
`
`Q.
`
`Do you see that?
`
`Yes.
`
`Why would a POSA be motivated
`
`to combine those two references in that way?
`
`A.
`
`Well, because at the time it
`
`was well known in the art that there were human
`
`factors involved in the therapeutic efficacy of
`
`inhaled dosage forms, and there was a
`
`motivation to try to make the devices that were
`
`being used as -- as obvious and easy for
`
`patients to use them correctly as possible.
`
`And so including additional indicators that
`
`
`
`allowed the patient to use the device as
`
`
`800-642-1099
`
`A Veritext Company
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`ww.veritext.com
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`David Feldman Worldwide
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`Page 113
`
`MAUREEN DONOVAN , Ph . D .
`
`designed was a motivation for everybody
`
`involved in pulmonary device development at the
`
`time.
`
`Q.
`
`Okay.
`
`Is there any statement
`
`in Voswinckel itself that provides a specific
`
`motivation to modify the nebulizer disclosed?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Well,
`
`there's nothing specific
`
`in the Circulation abstract, but even comparing
`
`the European Heart Journal abstract to the
`
`Circulation abstract, it's obvious that the ——
`
`that Voswinckel changed nebulizers.
`
`So he was
`
`certainly aware that one could select a
`
`different nebulizer for whatever purpose one
`
`needed to during a -- you know, during a series
`
`of investigations.
`
`So it doesn't expressly state
`
`that, but I
`
`think there's a clear indication
`
`that by just comparing those two abstracts,
`
`that Voswinckel and certainly others in the art
`
`were open to selecting a device where they were
`
`confident that that device was accomplishing
`
`
`
`they desired for patient treatment.
`what
`
`
`800-642-1099
`
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`Page 114
`
`MAUREEN DONOVAN , Ph . D .
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay.
`
`So you referred to the
`
`European Heart JOurnal abstract, and what I am
`
`trying to do is focus just on your statement in
`
`paragraph 125 about a motivation to combine
`
`Voswinckel's teachings with Patton's teachings.
`
`So -- and I understand your
`
`testimony that you believe there are human
`
`factor considerations that a POSA would
`
`consider that would guide the motivation to
`
`combine those teachings in particular ways.
`
`Did I understand your testimony correctly?
`
`A.
`
`Q.
`
`Yes.
`
`What
`
`I
`
`am trying to understand
`
`is is there a statement in either of those two
`
`references explicitly in Voswinckel or in
`
`Patton that motivates a person of ordinary
`
`skill in the art to modify one or the other to
`
`arrive at the invention that is claimed in the
`
`patents at issue?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Well, again, a POSA is -- is
`
`
`
`aware of the activities Surrounding device
`
`
`800-642-1099
`
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`Page114of201
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`MAUREEN DONOVAN,
`
`Ph.D.
`
`Page 115
`
`development for inhalation delivery, and
`
`certainly understood the teachings of Patton
`
`and some of the
`
`-- both the technology to form
`
`the aerosol and other portions of the device
`
`that Patton describes and their attributes and
`
`understands the attributes of other devices,
`
`some of which were more readily available
`
`potentially in particular regions.
`
`And as a result,
`
`there's a
`
`motivation from the POSA to always try to ——
`
`try to identify some of the best qualities of
`
`the art at the time and include them in a next
`
`stage in this case we are talking about
`
`devices.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay.
`
`So I understand you
`
`said there‘s a motivation from the POSA to
`
`always try to identify the best qualities of
`
`the art at the time,
`
`but my question is you
`
`don't identify an explicit statement in either
`
`of Voswinckel or Patton that directly invites a
`
`POSA to modify the teachings to combine them;
`
`is that right?
`
`
`
`MR. MATHAS:
`Object to the form.
`
`
`800-642-1099
`
`David Feldman Worldwide
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`Page1150f201
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`Page 116
`
`MAUREEN DONOVAN, Ph.D.
`
`BY THE WITNESS:
`
`A.
`
`Well,
`
`the POSA would realize
`
`that the OptiNeb nebulizer family already had
`
`the physical capabilities to have an
`
`opto-acoustic trigger, and the device described
`
`in Patton describes that as a component of the
`
`device. And the POSA essentially is learning
`
`from Patton that -- and knew this likely even
`
`before Patton described it in the specific ——
`
`in the specific patent based on the fact that
`
`there were other devices available that used ——
`
`used lights, used sounds, used other things to
`
`indicate to patients how to use the device
`
`appropriately.
`
`So the motivation is that
`
`Patton describes using light and sound to
`
`indicate something about the dose being ready
`
`for the patient, and that‘s easily transferable
`
`to a different device that is easily capable of
`
`using those same sensory readouts to improve
`
`the ability of a patient to use that device
`
`correctly.
`
`BY MS. ASCARRUNZ:
`
`
`
`Q.
`I understand your testimony.
`
`
`800-642-1099
`
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`Page1160f201
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`Page 117
`
`MAUREEN DONOVAN , Ph . D .
`
`I do. But that wasn't the question that I
`
`asked.
`
`So let me go about it this way.
`
`in the Voswinckel reference that invites a POSA
`
`Can you point to a statement
`
`to modify the device used in that reference in
`
`any way?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Again,
`
`the Voswinckel
`
`Circulation abstract is merely an abstract.
`
`It's a very abbreviated form of information
`
`that‘s being presented, but even in its very
`
`abbreviated form when I compare it to a similar
`
`abstract by a similar group of investigators,
`
`I
`
`already see that they have changed the
`
`nebulizer from a continuous nebulizer to a
`
`pulse nebulizer.
`
`It tells me that they are open
`
`to the opportunity of improvements or changes
`
`in a nebulizer to advantage some
`
`characteristics of those nebulizers for
`
`improved patient therapy, and knowing that
`
`there are other improvements from a human
`
`
`
`factors standpoint that could yet again improve
`
`
`800-642-1099
`
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`Page 118
`
`MAUREEN DONOVAN, Ph.D.
`
`the usefulness,
`
`the ability of patients to use
`
`the nebulizers correctly in an outpatient
`
`setting, not in the acute care setting that was
`
`described in the Voswinckel Circulation
`
`abstract, certainly there's a motivation to
`
`provide the -- the invention or the -- provide
`
`the best possible characteristics in any
`
`nebulizer to provide to a set of patients who
`
`are in need of a reproducible, accurate,
`
`at—home nebulizer system for an important
`
`therapy.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Is that motivation made
`
`explicit in the text of Voswinckel?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Again, a POSA doesn't need a
`
`specific text to direct them to --
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`And that wasn't my question.
`
`My question was --
`
`MR. MATHAS: Veronica, you have to
`
`let her answer.
`
`Then you can ask your question
`
`
`
`again if you don't like her answer.
`
`
`800-642-1099
`
`A Veritext Company
`
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`PageI180f201
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`IbLAJl'OH
`($403111
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`Page 119
`
`MAUREEN DONOVAN, Ph.D.
`
`BY THE WITNESS:
`
`A.
`
`So, again, a POSA doesn't need
`
`specific direction to take known information in
`
`the art and utilize it and combine it, and
`
`whether there‘s something actually specifically
`
`in an abstract an abbreviated description of a
`
`body of work that suggests that or not,
`
`that --
`
`a POSA doesn't need that.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`I understand that.
`
`I'm asking
`
`the question whether -- so I understand that
`
`it's your testimony that a POSA did have a
`
`motivation to combine those two references as
`
`you have indicated, and you've testified at
`
`length as to where you believe that motivation
`
`would reside in the considerations of a POSA.
`
`Is that a fair
`
`characterization of your testimony?
`
`A.
`
`Q.
`
`Yes.
`
`Okay. All
`
`I am trying to
`
`establish is that that motivation was in the
`
`mind-set and considerations of a POSA and not
`
`in a sentence in one of these references.
`
`So I
`
`
`
`am asking you to identify is there a sentence
`
`
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`PageI190f201
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`Page 120
`
`MAUREEN DONOVAN , Ph . D .
`
`in Voswinckel that provides a motivation to
`
`modify the device used in Voswinckel?
`
`MR. MATHAS: Asked and answered.
`
`BY THE WITNESS:
`
`A.
`
`There's not a specific
`
`sentence that -- in the Voswinckel Circulation
`
`abstract that describes anything about needing
`
`or desiring to change the device in their
`
`future studies.
`
`It doesn't necessarily mean
`
`that they —— they hadn't or another POSA
`
`wouldn‘t contemplate doing that.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay.
`
`Is there a specific
`
`statement or sentence in the Patton reference
`
`that invites a POSA to use the features
`
`described for the treatment of pulmonary
`
`hypertension?
`
`A.
`
`Well, again, Patton is open to
`
`the use of the device described in the '951
`
`patent application or however we want to refer
`
`to that. That his device provides a method to
`
`deliver a medicament by inhalation to reach the
`
`lungs of the patient which means that to a POSA
`
`
`
`that any treatment that a POSA would need to
`
`
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`Page 121
`
`MAUREEN DONOVAN, Ph.D.
`
`reach the lungs to achieve the treatment goal
`
`that the Patton device is capable of being
`
`utilized to do that.
`
`BY MS.
`
`ASCARRUNZ:
`
`(Reporter Clarification.)
`
`Q.
`
`Earlier in your discussion of
`
`a POSA being motivated to modify the device
`
`used in Voswinckel, you referred to the
`
`Voswinckel Exhibit 1047 reference.
`
`Do you recall that discussion?
`
`A.
`
`I
`
`think I need to be reminded
`
`what the Voswinckel 1047 reference is.
`
`Q.
`
`Sometimes we refer to it as
`
`Voswinckel II, but it's the European Heart
`
`Journal.
`
`A.
`
`Okay.
`
`Can I
`
`take a look at
`
`that reference?
`
`MR. MATHAS:
`
`1046?
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`A.
`
`abstract.
`
`Did I -- sorry, 1046.
`
`So it's European Heart Journal
`
`Q.
`
`Yes.
`
`
`
`A.
`Okay. Yes. All right.
`
`
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`Page 122
`
`MAUREEN DONOVAN , Ph . D .
`
`Q.
`
`So when I asked you about
`
`the
`
`motivation in Voswinckel
`
`to modify the device,
`
`you told -- you referred me
`
`to this other
`
`Voswinckel reference and said that it tells you
`
`that they are open to the opportunity of
`
`improvements or changes in a nebulizer to
`
`advantage some characteristics of those
`
`nebulizers for improved patient therapy.
`
`A.
`
`Q.
`
`Do you recall that testimony?
`
`Yes.
`
`What does this reference which
`
`I will start referring to as Voswinckel II just
`
`for clarity of the record, tell you about the
`
`willingness of the investigators to improve ——
`
`to make improvements or changes to the
`
`nebulizer?
`
`A.
`
`Well,
`
`the Voswinckel II
`
`abstract describes the use of an OptiNeb
`
`ultrasound nebulizer and a six-minute
`
`inhalation exposure, and the Voswinckel
`
`American Heart Association abstract describes
`
`using three single breaths from a pulsed
`
`OptiNeb ultrasonic nebulizer, and it was
`
`
`
`certainly very well known in the field for
`
`
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`Page1220f201
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`Page 123
`
`MAUREEN DONOVAN , Ph . D .
`
`nebulizer therapy that reducing the amount of
`
`time to achieve the dose needed for a patient
`
`was an important aspect of nebulizer therapy
`
`and patient adherence to nebulizer therapy.
`
`So moving from a six-minute
`
`nebulization to a three inhalation therapy
`
`whether that was accomplished exactly by a
`
`change in nebulizer or accomplished by other
`
`activities in addition was certainly something
`
`that Voswinckel demonstrates that groups were
`
`aware of and were in relatively similar
`
`timeframes evaluating the opportunity to use a
`
`device that provided a better user experience.
`
`Q.
`
`Okay. Now, you are aware that
`
`the single ground that the Board instituted for
`
`decision in this trial was the question ——
`
`speaking just to the '240 patent, was limited
`
`to the question of obviousness over Voswinckel
`
`in view of Patton and Ghofrani, correct?
`
`A.
`
`Q.
`
`In the '240 patent, yes.
`
`But it's your opinion that in
`
`part a motivation to combine those references
`
`is evidenced by Voswinckel II, correct?
`
`
`
`I don't need Voswinckel
`No,
`A.
`
`
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`Page 124
`
`MAUREEN DONOVAN, Ph.D.
`
`II, but you were asking directly about specific
`
`statements in Voswinckel I, and because it's an
`
`abstract, it‘s a very short description of work
`
`conducted and has often times very little
`
`description about what other information the
`
`authors are thinking, and so I
`
`look to other
`
`evidence even from the same group to
`
`demonstrate that, yes,
`
`those other —-
`
`those
`
`investigators were thinking about other things
`
`to improve this therapy beyond just the mere
`
`words that are included in the written
`
`description in the abstract.
`
`Voswinckel II to come to the —— to come to the
`
`And so I don't need to rely on
`
`opinions that I did in the matter of the ‘50?
`
`or
`
`'240 patents. Merely use that as an obvious
`
`example of even whether it's -- whether
`
`something is actually stated clearly in an
`
`abstract.
`
`It was clear that even that same
`
`research group understood that that was a
`
`consideration and a motivation.
`
`Q.
`
`Okay.
`
`So because Voswinckel I
`
`is an abstract and it's a very short
`
`
`
`description of work conducted and has often
`
`
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`Page 125
`
`MAUREEN DONOVAN , Ph . D .
`
`times very little description about what other
`
`information the authors are thinking, you
`
`looked to Voswinckel II to supplement that
`
`understanding, correct?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`No, that's not correct.
`
`I
`
`didn't need to look to Voswinckel II. We
`
`started discussing Voswinckel II because I was
`
`answering questions you were asking about
`
`specific statements included in the Voswinckel
`
`I abstract that would have described the
`
`author‘s thoughts, desires,
`
`I don't remember
`
`the wording about the nebulizer, and I provided
`
`you with actual evidence of what would be clear
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`to a POSA that there -- that those
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`investigators must have been thinking about
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`issues regarding modifying the nebulizers being
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`used because they demonstrated that they even
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`did that in order to modify the dosing regimen
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`that they used that was different between those
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`two, but I don't need to rely on Voswinckel II
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`for that.
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`I was using that as an example to
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`
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`answer your questions.
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`800-642-1099
`
`A Veritext Company
`
`www.veritext.com
`
`David Feldman Worldwide
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-0162‘I
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`Pa991250f201
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`IbLAJl'OH
`oo-qoxu-I
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`Page 126
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`MAUREEN DONOVAN, Ph.D.
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`BY MS. ASCARRUNZ:
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`Q.
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`Do you need to refer to
`
`Voswinckel II to understand the motivation of
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`the Voswinckel I authors to modify the device
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`disclosed therein?
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`MR. MATHAS: Object to the form.
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`BY THE WITNESS:
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`A.
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`No. Again, a POSA understood
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`that certainly at the time of the priority date
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`of the '240 and the '50? patents it was well
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`known that in evaluating human factors and
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`improving the human interface with devices was
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`an important
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`thing to do in order to improve
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`user -- improve the use of the device,
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`improve
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`the adherence to the design dosing strategies
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`and so forth.
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`It was -- POSA's were well
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`aware of those issues and were motivated to try
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`to find ways to improve devices to address
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`human factors issues and improve patient
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`interactions with devices.
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`BY MS. ASCARRUNZ:
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`Q.
`
`Okay. Where in Voswinckel I
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`
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`is it said that three breaths are delivered in
`
`
`800-642-1099
`
`A Veritext Company
`
`ww.veritext.com
`
`David Feldman Worldwide
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-0162‘I
`
`Pa991260f201
`
`
`
`IbLAJl'OH
`(ID-403111
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`Page 127
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`MAUREEN DONOVAN , Ph . D .
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`less than six minutes?
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`A.
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`It doesn't -- let's see.
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`Voswinckel
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`I doesn't specifically indicate the
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`timeframe over which the three breaths were
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`taken, but a POSA reading this and, again, if
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`it was -- if the ocCurrence or the
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`description -- start over.
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`If the methodology used by the
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`investigators was going to differ significantly
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`from what a reader of this abstract would be
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`expected to understand,
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`the authors typically
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`make additional -- put in additional
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`information into the abstract.
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`So those
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`methods are clear.
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`So not having additional
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`information indicates that a POSA is free to
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`believe that this medication was dosed in the
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`same way You would dose other medications with
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`the OptiNeb ultrasound nebulizer which means
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`three single breaths receiving the dose over a
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`relatively short interval of time, certainly
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`far less than six minutes.
`
`Q.
`
`Okay. We were talking about
`
`
`
`paragraph 125, and the last senten