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`·1· · · · · ·UNITED STATES PATENT AND TRADEMARK OFFICE
`·2· · · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
`·3
`·4· ·LIQUIDIA TECHNOLOGIES,· ·)
`· · ·INC.,· · · · · · · · · · )
`·5· · · · · · · · · · · · · · ) IPR 2021-00406
`· · · · · · · · ·Petitioner,· ) U.S. Patent No. 10,716,793
`·6· · · · · · · · · · · · · · )
`· · · · · · vs.· · · · · · · ·) VOLUME II
`·7· · · · · · · · · · · · · · )
`· · ·UNITED THERAPEUTICS· · · )
`·8· ·CORPORATION,· · · · · · ·)
`· · · · · · · · · · · · · · · )
`·9· · · · · · · ·Patent Owner.)
`· · ·_________________________)
`10
`11
`12
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`14
`15· · · · · · · · · · ·REMOTE DEPOSITION OF
`16· · · · · · · · · · · ·IGOR GONDA, Ph.D.
`17· · · · · · · · · · · · MARCH 14, 2022
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`· · ·Reported by:
`24· ·Susan Myong
`· · ·CSR 13365
`25· ·Job No. 10097372
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`·1· · · · · ·UNITED STATES PATENT AND TRADEMARK OFFICE
`·2· · · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
`·3
`·4· ·LIQUIDIA TECHNOLOGIES,· ·)
`· · ·INC.,· · · · · · · · · · )
`·5· · · · · · · · · · · · · · ) IPR 2021-00406
`· · · · · · · · ·Petitioner,· ) U.S. Patent No. 10,716,793
`·6· · · · · · · · · · · · · · )
`· · · · · · vs.· · · · · · · ·) VOLUME II
`·7· · · · · · · · · · · · · · )
`· · ·UNITED THERAPEUTICS· · · )
`·8· ·CORPORATION,· · · · · · ·)
`· · · · · · · · · · · · · · · )
`·9· · · · · · · ·Patent Owner.)
`· · ·_________________________)
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`11
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`14· · · · · · REMOTE DEPOSITION OF IGOR GONDA, Ph.D., a
`15· · · · · · witness herein, taken on behalf of Patent
`16· · · · · · Owner, at 1:09 p.m., on Monday, March 14,
`17· · · · · · 2022, before Susan Myong, CSR 13365.
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`·1· ·APPEARANCES OF COUNSEL:
`·2
`· · ·For Petitioner:
`·3
`·4· · · · · · · ·COOLEY LLP
`· · · · · · · · ·BY:· JONATHAN DAVIES, ESQ.
`·5· · · · · · · · · · DOUGLAS CHEEK, ESQ.
`· · · · · · · · ·3175 Hanover Street
`·6· · · · · · · ·Palo Alto, California 94304-1130
`· · · · · · · · ·(650)843-5673
`·7· · · · · · · ·jdavies@cooley.com
`· · · · · · · · ·dcheek@cooley.com
`·8
`·9· ·For Patent Owner:
`10
`· · · · · · · · ·MCDERMOTT WILL & EMERY LLP
`11· · · · · · · ·BY:· ART DYKHUIS, ESQ.
`· · · · · · · · · · · JOSHUA REVILLA, ESQ.
`12· · · · · · · ·18565 Jamboree Road
`· · · · · · · · ·Suite 250
`13· · · · · · · ·Irvine, California 92612-2565
`· · · · · · · · ·(949)620-6111
`14· · · · · · · ·adykhuis@mwe.com
`15
`· · ·Also Present:· Gianni Ortiz, Exhibit Tech
`16
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`·1· · · · · · · · · · · · · ·I N D E X
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`·2· ·WITNESS:· IGOR GONDA, Ph.D.
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`Page 143
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`·3· ·EXAMINATION BY:· · · · · · · · · · · · · · · · PAGE
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`·4· ·MR. DYKHUIS· · · · · · · · · · · · · · · · · · 145
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`10· · · · · · · · · · · · E X H I B I T S
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`11· ·NUMBER· · · · · DESCRIPTION· · · · · · · · · · · · ·PAGE
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`12· ·EXHIBIT 1007· · Vos JESC· · · · · · · · · · · · · · 192
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`13· ·EXHIBIT 1062· · Ultrasonic vs Jet Nebulization· · · 163
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`14· ·EXHIBIT 1099· · Leigh 1991· · · · · · · · · · · · · 180
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`15· ·EXHIBIT 1107· · Reply declaration· · · · · · · · · ·150
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`16· ·EXHIBIT 2100· · Tab 6· · · · · · · · · · · · · · · ·164
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`17· ·EXHIBIT 2101· · Tab 5· · · · · · · · · · · · · · · ·174
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`18· ·EXHIBIT 2102· · Tab 9· · · · · · · · · · · · · · · ·180
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`19· ·EXHIBIT 2103· · Tab 4· · · · · · · · · · · · · · · ·198
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`·1· · · · · · · · · · Monday, March 14, 2022
`·2· · · · · · · · · · · · · ·1:09 p.m.
`·3
`·4· · · · · · THE REPORTER:· Pursuant to the Federal Rules of
`·5· ·Civil Procedure, I am required to state the following:
`·6· ·My name is Susan Myong.· My business address is 21143
`·7· ·Hawthorne Boulevard, Number 323, Torrance, California
`·8· ·90503.· This is the deposition of Igor Gonda, Ph.D., in
`·9· ·the matter of Liquidia Technologies v. United
`10· ·Therapeutics Corp, beginning at 1:09 Pacific Standard,
`11· ·on Monday, March 14, 2022.· This deposition is being
`12· ·taken remotely with the witness located in Melbourne,
`13· ·Australia.
`14· · · · · · Do all counsel agree that I may swear in the
`15· ·witness remotely?
`16· · · · · · MR. DYKHUIS:· Yes.
`17· · · · · · MR. DAVIES:· Yes.
`18· · · · · · THE REPORTER:· Please state your appearances
`19· ·and anyone with you, starting with the taking attorney,
`20· ·and then you may begin.
`21· · · · · · MR. DYKHUIS:· Yeah.· Art Dykhuis with
`22· ·McDermott, Will & Emery on behalf of the patent owner,
`23· ·United Therapeutics Corporation, and with me is
`24· ·Josh Revilla also from McDermott.
`25· · · · · · MR. DAVIES:· Jonathan Davies from Cooley LLP
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`·1· ·for petitioner Liquidia Technologies.· And with me
`·2· ·today, also from Cooley, is my colleague, Douglas Cheek.
`·3
`·4· · · · · · · · · · · IGOR GONDA, Ph.D.,
`·5· ·a witness herein, having been sworn remotely, testifies
`·6· ·as follows:
`·7
`·8· · · · · · · · · · · · ·EXAMINATION
`·9· ·BY MR. DYKHUIS:
`10· · · ·Q· · Well, good morning, Dr. Gonda.
`11· · · ·A· · Hello.
`12· · · ·Q· · Thank you for finding some time for us for this
`13· ·deposition today.· Some of this will be -- sound similar
`14· ·because we've done this a couple times before, but can
`15· ·you just state your full name for the record, please.
`16· · · ·A· · Igor Gonda.
`17· · · ·Q· · What is your address, sir?
`18· · · ·A· · My address in the United States is 683 Main
`19· ·Street, Dennis, Massachusetts ZIP Code 02638.· And unit
`20· ·number is B24.· But currently I'm at Unit 2, 58-62 Marne
`21· ·Street, South Yarra, Victoria, 3141 Australia.
`22· · · ·Q· · And are you at home for the deposition?
`23· · · ·A· · I'm at home.
`24· · · ·Q· · Is there anyone there at home with you in the
`25· ·room?
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`·1· · · ·A· · I think that they're all still asleep.
`·2· · · ·Q· · Do you have any communication devices open or
`·3· ·chat windows or anything of the like for communication
`·4· ·during the deposition?
`·5· · · ·A· · No.· All that I have at present is the Zoom
`·6· ·screen.
`·7· · · ·Q· · Do you have any documents with you, Dr. Gonda?
`·8· · · ·A· · I got my reply declaration for this case, for
`·9· ·IPR.
`10· · · ·Q· · And is that -- just to confirm, you're talking
`11· ·about Exhibit 1107?
`12· · · ·A· · Yes, that's correct.
`13· · · ·Q· · Does that copy have any notes or annotations or
`14· ·markings on it?
`15· · · ·A· · No, it does not.
`16· · · ·Q· · Other than the reply declaration, do you have
`17· ·any other documents with you?
`18· · · ·A· · No, I don't.
`19· · · ·Q· · As a reminder, Dr. Gonda, you understand that
`20· ·even though this is a deposition being conducted
`21· ·remotely, you're under the same oath as you would be in
`22· ·court; correct?
`23· · · ·A· · Yes.
`24· · · ·Q· · And just a reminder to -- let's try to not
`25· ·speak over each other and not too quickly for our court
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`·1· ·reporter.· And if you don't understand a question,
`·2· ·please let me know.· If you do answer, I'll assume you
`·3· ·understood the question; is that fair?
`·4· · · ·A· · Yes.
`·5· · · ·Q· · Thank you.
`·6· · · ·A· · Yes.
`·7· · · ·Q· · I know that you have a stop later this morning,
`·8· ·so I'll try to move quickly today.· Usually I do take a
`·9· ·break every hour or so.· If you need a break at some
`10· ·point, we can do that as long as you answer any pending
`11· ·questions; is that fair?
`12· · · ·A· · Yes.
`13· · · ·Q· · Is there any reason you cannot give full, true,
`14· ·and accurate testimony today?
`15· · · ·A· · I'm unaware of any reasons.
`16· · · ·Q· · How did you prepare for today's deposition,
`17· ·Dr. Gonda?
`18· · · ·A· · I had a conversation with the counsel about the
`19· ·deposition yesterday.
`20· · · ·Q· · For how long was that conversation?
`21· · · ·A· · About three hours.
`22· · · ·Q· · Who participated in that conversation?
`23· · · ·A· · It was the same counsel as we have today,
`24· ·Jonathan Davies and Douglas Cheek, and there was also
`25· ·another Cooley lawyer present.
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`·1· · · ·Q· · Who was the other lawyer?
`·2· · · ·A· · Deepa, if I can pronounce it, Kannappan.· Yeah.
`·3· · · ·Q· · Okay.· Did you speak with anyone else other
`·4· ·than that conversation with three lawyers yesterday in
`·5· ·preparation for today's deposition?
`·6· · · ·A· · No, I did not.
`·7· · · ·Q· · So you mentioned you have a copy of your reply
`·8· ·declaration in front of you, Exhibit 1107, in this IPR.
`·9· · · ·A· · Yes, I do.
`10· · · ·Q· · Did you work with counsel to prepare that
`11· ·declaration?
`12· · · · · · MR. DAVIES:· Objection.· Form.
`13· · · · · · THE WITNESS:· Sorry.· Could you please repeat
`14· ·the question.
`15· ·BY MR. DYKHUIS:
`16· · · ·Q· · Did you work with counsel to prepare the
`17· ·declaration?
`18· · · ·A· · Yes, I did.
`19· · · · · · MR. DAVIES:· Objection to form.
`20· · · · · · You can answer.
`21· · · · · · THE WITNESS:· Yes, I did.
`22· ·BY MR. DYKHUIS:
`23· · · ·Q· · Which counsel did you work with to prepare the
`24· ·reply declaration?
`25· · · ·A· · You know, I don't recall who are the people,
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`·1· ·but I think that it was the same three people that I
`·2· ·talked to yesterday.
`·3· · · ·Q· · Okay.· Who did you work with the most of
`·4· ·Mr. Davies, Mr. Cheek, and Ms. Kannappan?
`·5· · · · · · MR. DAVIES:· Objection.· Form.
`·6· · · · · · THE WITNESS:· Mr. Douglas Cheek.
`·7· ·BY MR. DYKHUIS:
`·8· · · ·Q· · There's also a litigation between United
`·9· ·Therapeutics and Liquidia; correct?· Are you aware?
`10· · · ·A· · You mean the district court litigation.
`11· · · ·Q· · Right.
`12· · · ·A· · Yes.· I'm aware of that, yes.
`13· · · ·Q· · Did you work with the same counsel to prepare
`14· ·expert reports in that litigation?
`15· · · · · · MR. DAVIES:· Objection.· Scope.· Form.
`16· · · · · · THE WITNESS:· Can I answer?
`17· · · · · · MR. DAVIES:· You can answer that, but -- you
`18· ·can go ahead and answer that.· That's okay.
`19· · · · · · THE WITNESS:· Yeah.· There was one other
`20· ·counsel involved from Cooley.
`21· ·BY MR. DYKHUIS:
`22· · · ·Q· · And who was that?
`23· · · ·A· · Can you help me?· Sanya -- yeah, I -- yeah, I
`24· ·really don't -- honestly don't remember the full name.
`25· ·Yup.
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`·1· · · ·Q· · Right.· Thank you.
`·2· · · · · · MR. DYKHUIS:· So, Mr. Ortiz, if you could share
`·3· ·an electronic copy of that Exhibit 1107, please.
`·4· · · ·Q· · Dr. Gonda, just let me know when that comes
`·5· ·through and then I have a couple questions on that.
`·6· · · ·A· · I don't see that.· Would it be in the chat?
`·7· · · ·Q· · I believe it will come through in the chat.
`·8· ·There you go.· You have the link right now.
`·9· · · ·A· · Okay.
`10· · · · · · MR. DYKHUIS:· Oh, so this is the wrong one.
`11· ·This is 1007.· Can we have 1107, please.
`12· · · · · · (Exhibit 1107 was marked for
`13· · · · · · identification and attached hereto.)
`14· ·BY MR. DYKHUIS:
`15· · · ·Q· · And then while we're waiting for that one to
`16· ·come through, Dr. Gonda, in preparing your reply IPR
`17· ·declaration, did you have any communication with
`18· ·Dr. Nicholas Hill?
`19· · · ·A· · No, I did not.
`20· · · ·Q· · So now you should have a copy of 1107.
`21· · · ·A· · Yes, I do.
`22· · · ·Q· · And is that 1107 the same document as what you
`23· ·have printed?
`24· · · ·A· · I believe it is.
`25· · · ·Q· · So feel free to look at either one.· I just
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`·1· ·wanted to confirm that we're looking at the same thing.
`·2· · · ·A· · Okay.
`·3· · · ·Q· · On the last page of the declaration --
`·4· · · ·A· · Yes.
`·5· · · ·Q· · -- is that your signature on page 50?
`·6· · · ·A· · It is.
`·7· · · ·Q· · Is everything in this reply declaration true as
`·8· ·far as you know?
`·9· · · ·A· · As far as I know, it is.
`10· · · ·Q· · Could you turn to paragraph 34, please.· Just
`11· ·let me know when you get there.
`12· · · ·A· · Yes, I'm working on it.
`13· · · ·Q· · Again, feel free to use the electronic or paper
`14· ·copy, whatever is easiest for you.
`15· · · ·A· · I'm using the electronic copy.· Thirty-four,
`16· ·yes.
`17· · · ·Q· · On paragraph 34, on page -- so it starts on
`18· ·page 25 and continues on to page 26.· On page 26, the
`19· ·third line, you make a reference to water as the -- "By
`20· ·far the most common and likely only solvent used in
`21· ·FDA-approved nebulizer solutions in May 2006."
`22· · · · · · And then at the end of paragraph 35 [sic], you
`23· ·state, "A POSA reading Voswinckel, J-E-S-C, JESC, would
`24· ·have reasonably assumed that the inhaled solution of
`25· ·treprostinil was aqueous."
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`·1· · · · · · Do you see that text?
`·2· · · ·A· · Yes, I do.
`·3· · · ·Q· · Is there -- in the context of a continuous
`·4· ·nebulizer -- let me back up actually.
`·5· · · · · · You recall the Voswinckel JESC reference as
`·6· ·describing a continuous nebulizer; correct?
`·7· · · ·A· · Yes.
`·8· · · ·Q· · In the context of a continuous nebulizer, such
`·9· ·as that in Voswinckel JESC and a solution prepared using
`10· ·water as the solvent, is there a maximum of how much
`11· ·water the air can hold as an aerosol upon nebulization?
`12· · · · · · MR. DAVIES:· Objection.· Form.
`13· · · · · · THE WITNESS:· Yes, there is a limit to how
`14· ·much -- sorry.· Can you please just explain the question
`15· ·to me.
`16· ·BY MR. DYKHUIS:
`17· · · ·Q· · So --
`18· · · ·A· · Can you just rephrase it.· Yes.
`19· · · ·Q· · Sure.
`20· · · · · · Is there a limit as to how much water or
`21· ·nebulized drug solution that the air can hold as an
`22· ·aerosol after nebulization?
`23· · · · · · MR. DAVIES:· Objection.· Form.
`24· · · · · · You can answer.
`25· · · · · · THE WITNESS:· I don't understand the question
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`·1· ·"hold."· There is no limit, provided that you've got
`·2· ·enough air.· And then, of course, it will depend on the
`·3· ·temperature and humidity of the air.· How much of that
`·4· ·material is in the liquid phase and how much has
`·5· ·evaporated.· So it's a complicated question that you're
`·6· ·asking.· But in principal, no, there is no limit.
`·7· ·BY MR. DYKHUIS:
`·8· · · ·Q· · So if you have a finite quantity of air, then
`·9· ·you would have a limit as to how much aerosol could be
`10· ·held in the air, depending on temperature and humidity
`11· ·as well; correct?
`12· · · ·A· · Yes.
`13· · · · · · MR. DAVIES:· Objection.· Form.
`14· ·BY MR. DYKHUIS:
`15· · · ·Q· · If you -- the Voswinckel JESC article, or
`16· ·abstract, identifies an OptiNeb nebulizer.
`17· · · · · · Do you remember that?
`18· · · ·A· · Yes.
`19· · · ·Q· · If you took the OptiNeb or a different
`20· ·ultrasonic nebulizer and you capped or plugged the
`21· ·mouthpiece -- are you with me so far?· Just cover the
`22· ·mouthpiece up.· Does that make sense so far?
`23· · · · · · MR. DAVIES:· Objection.· Form.
`24· · · · · · THE WITNESS:· The only -- sorry.· You would
`25· ·stop -- can you just repeat it.· You would -- what would
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`·1· ·you do?
`·2· ·BY MR. DYKHUIS:
`·3· · · ·Q· · If you covered or plugged the mouthpiece on the
`·4· ·nebulizer and then you run the nebulizer in a continuous
`·5· ·mode -- are you with me so far?
`·6· · · ·A· · Yes.
`·7· · · ·Q· · -- eventually the air inside the nebulizer will
`·8· ·become saturated with the aerosol; correct?
`·9· · · · · · MR. DAVIES:· Objection.· Form.
`10· · · · · · THE WITNESS:· Yes.· It would be accumulating.
`11· ·I'm not sure that it's going to be saturated, but it
`12· ·will be accumulating.· Now, I think, what I said before,
`13· ·the balance between the amount evaporated and the amount
`14· ·in the water droplet might be changing, yes.
`15· · · · · · Yeah.· I don't know what you're getting at, so
`16· ·can you just --
`17· ·BY MR. DYKHUIS:
`18· · · ·Q· · Well, what I'm --
`19· · · ·A· · -- just explain what is the context of this,
`20· ·please.
`21· · · ·Q· · Sure.· I'll get there.
`22· · · · · · I'm thinking of the word "condensation." I
`23· ·don't know if that's the right terminology.· But in the
`24· ·question I posed to you, with an OptiNeb nebulizer and
`25· ·the mouthpiece is capped and it's running in a
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`·1· ·continuous mode --
`·2· · · ·A· · Yes.· I mean, it's a hypothetical question.
`·3· ·I don't know why anybody would be using a continuous
`·4· ·nebulizer with the mouthpiece plugged.· I mean, I just
`·5· ·don't understand why we are discussing it.
`·6· · · ·Q· · Sure.· Yeah, no.· That's fine.· We'll get
`·7· ·there.
`·8· · · · · · So my question is:· You have talked about the
`·9· ·rate for continuous nebulizers before and their rate of
`10· ·output.· And my question for you is:· If the mouthpiece
`11· ·on a nebulizer was capped, wouldn't the rate of the
`12· ·nebulization slow down as the air inside the nebulizer
`13· ·becomes saturated with aerosol?
`14· · · · · · MR. DAVIES:· Objection.· Form.
`15· · · · · · THE WITNESS:· There is -- it's not called
`16· ·condensation.· It's called sedimentation.· So some of
`17· ·the droplets would sediment, but that still would not
`18· ·have a big impact on output.· No.
`19· ·BY MR. DYKHUIS:
`20· · · ·Q· · So you said -- so if a nebulizer was running in
`21· ·continuous mode and the mouthpiece is capped, it's your
`22· ·opinion that the output would maintain essentially the
`23· ·same, no matter how long the nebulizer continued
`24· ·running?
`25· · · · · · MR. DAVIES:· Objection.· Form.
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`·1· · · · · · You can answer.
`·2· · · · · · THE WITNESS:· No.· But I just said it's a
`·3· ·hypothetical question because in reality, the nebulizer
`·4· ·would be -- the mouthpiece would be open because the
`·5· ·patient -- the subject is inhaling on it.· So I just
`·6· ·don't understand why we are discussing it.· I mean, if
`·7· ·it is in the -- yeah, if it is in continuous mode, then
`·8· ·the aerosol would be either going out into the patient
`·9· ·or it would be coming out of the mouthpiece when the
`10· ·patient is exhaling.· So I just don't understand what is
`11· ·the situation in reality that this would represent.
`12· ·BY MR. DYKHUIS:
`13· · · ·Q· · So when a patient breathes, they inspire, and
`14· ·then they might either immediately breathe out or they
`15· ·might hold their breath momentarily; is that correct?
`16· · · ·A· · Yes.· But with continuous nebulization there is
`17· ·not -- usually it is not recommended that the patient
`18· ·will hold their breath.· They continuously -- they
`19· ·breathe normal.
`20· · · ·Q· · And when the patient breathes out, they keep
`21· ·their mouth on the mouthpiece; correct?
`22· · · ·A· · There is usual -- yes.· Yeah.· They will keep
`23· ·typically their mouths on the mouthpiece if it's usually
`24· ·an exhaust valve.
`25· · · ·Q· · Can the humidity -- excuse me.· You mentioned
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`·1· ·earlier temperature and humidity.
`·2· · · · · · Both of those things affect how much aerosol
`·3· ·can be held in the air; correct?
`·4· · · ·A· · Yes.
`·5· · · ·Q· · Could temperature and humidity have an effect
`·6· ·on the rate of nebulization from a continuous ultrasonic
`·7· ·nebulizer?
`·8· · · ·A· · They have relatively smaller effect than the
`·9· ·jet nebulizers.· There is some effect, but it's
`10· ·relatively small.
`11· · · ·Q· · Let's look at paragraph 22 in your reply
`12· ·declaration, please.· And just let me know when you're
`13· ·there, Dr. Gonda.
`14· · · ·A· · Yes, I'm there.
`15· · · ·Q· · So on the first sentence, you reference
`16· ·Professor McConville and his position regarding
`17· ·nebulizer devices can have a wide variety of
`18· ·efficiencies.
`19· · · · · · You see the first sentence in your -- in
`20· ·paragraph 22?
`21· · · ·A· · Yes, I do.
`22· · · ·Q· · And then about halfway down the page, still in
`23· ·paragraph 22, you say, "In fact, the only ultrasonic
`24· ·nebulizer cited by Professor McConville had an
`25· ·efficiency of 86 percent."
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`·1· · · · · · Do you see that?
`·2· · · ·A· · Correct.
`·3· · · ·Q· · Do all ultrasonic nebulizers have an efficiency
`·4· ·of 86 percent?
`·5· · · ·A· · No.
`·6· · · ·Q· · Did all ultrasonic nebulizers in 2006, have an
`·7· ·efficiency of 86 percent?
`·8· · · ·A· · No.
`·9· · · ·Q· · But some ultrasonic nebulizers in 2006, would
`10· ·have an efficiency of lower than 86 percent; correct?
`11· · · · · · MR. DAVIES:· Objection.· Form.
`12· · · · · · THE WITNESS:· That is possible.
`13· · · · · · But in the context of JESC, that group of
`14· ·people, addition, were in a number of the publications
`15· ·emphasizing that they are striving towards high
`16· ·efficiency, rapid nebulization to increase the
`17· ·convenience for patients.· So I would have expect that
`18· ·whatever that group was using in that abstract, which
`19· ·was quite late in the process -- the product development
`20· ·for pulmonary artery hypertension treatment with
`21· ·prostacyclin, that they would have used one of the
`22· ·higher efficiency nebulizers.
`23· ·BY MR. DYKHUIS:
`24· · · ·Q· · But as far as my question, some ultrasonic
`25· ·nebulizers in 2006, would have had an efficiency of
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`·1· ·lower than 86 percent; correct?
`·2· · · · · · MR. DAVIES:· Objection.· Form.
`·3· · · · · · THE WITNESS:· Yes.
`·4· · · · · · MR. DAVIES:· You can answer.
`·5· · · · · · THE WITNESS:· That -- yes.
`·6· ·BY MR. DYKHUIS:
`·7· · · ·Q· · Do you have an opinion on how many ultrasonic
`·8· ·nebulizers were available and known to the POSA in 2006?
`·9· · · ·A· · I really wouldn't know how many ultrasonic
`10· ·nebulizers were familiar to the POSA, no.
`11· · · ·Q· · Do you think it would be ten or more?
`12· · · ·A· · Yes.· That would be a reasonable number, yeah.
`13· · · ·Q· · Could it be 20?
`14· · · ·A· · I don't think that a POSA would have considered
`15· ·as many as 20, no.
`16· · · ·Q· · Let me make sure I understand.· You said -- you
`17· ·used the word "considered."
`18· · · · · · Do you think that there were publicly available
`19· ·or in existence in 2006, at least 20 ultrasonic
`20· ·nebulizers?
`21· · · · · · MR. DAVIES:· Objection.· Form.
`22· · · · · · THE WITNESS:· I would say I probably would have
`23· ·been aware of 5 to 10 ultrasonic nebulizers, but not 20.
`24· ·No.
`25· ·///
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`·1· ·BY MR. DYKHUIS:
`·2· · · ·Q· · I'll start over.· It sounds like there could be
`·3· ·more than ten that were available in 2006.· You were
`·4· ·just aware of maybe five or ten; is that correct,
`·5· ·Dr. Gonda?
`·6· · · · · · MR. DAVIES:· Objection.· Form.
`·7· · · · · · THE WITNESS:· Hypothetically, yes, there could
`·8· ·have been more.· I -- yeah, I would have thought people
`·9· ·would be looking at five to ten.· POSAs would be looking
`10· ·at five to ten.
`11· ·BY MR. DYKHUIS:
`12· · · ·Q· · In preparing your reply declaration, you didn't
`13· ·research how many ultrasonic nebulizers were available
`14· ·to the POSA in 2006?
`15· · · · · · MR. DAVIES:· Objection.· Form.
`16· · · · · · THE WITNESS:· I did not do an exhaustive search
`17· ·of all the ultrasonic nebulizers.
`18· ·BY MR. DYKHUIS:
`19· · · ·Q· · So you did not research the efficiency for all
`20· ·of the ultrasonic nebulizers that were available to the
`21· ·POSA in 2006?
`22· · · · · · MR. DAVIES:· Objection.· Form.
`23· · · · · · THE WITNESS:· I did not do an exhaustive
`24· ·research of efficiency of all the ultrasonic nebulizers
`25· ·available in 2006, no.
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`·1· · · · · · (Reporter asks for clarification.)
`·2· · · · · · THE WITNESS:· I did not do an exhaustive
`·3· ·research of all the ultrasonic nebulizers available in
`·4· ·2006.
`·5· ·BY MR. DYKHUIS:
`·6· · · ·Q· · Give me just one moment, Dr. Gonda.· Thank you.
`·7· · · · · · As far as -- let me just clarify.
`·8· · · · · · In terms of the efficiency in paragraph 22 of
`·9· ·your reply declaration and the efficiency of the
`10· ·86 percent that you identified, is that referring to the
`11· ·percentage of drug that exits the mouthpiece compared to
`12· ·what was put into the nebulizer?
`13· · · ·A· · If you look at the Gessler publication, it
`14· ·actually defines the efficiency in a different way.· So
`15· ·the 86 percent is defined as the percent of the
`16· ·material, which is coming out at the mouthpiece divided
`17· ·by the overall output from the nebulizer.· So it's a
`18· ·very specific definition of efficiency.· And they
`19· ·describe the experimental procedure, how they define the
`20· ·efficiency.
`21· · · ·Q· · So it's the quantity coming out of the
`22· ·mouthpiece divided by the overall output of the
`23· ·nebulizer; correct?
`24· · · ·A· · That is correct.· Yes.
`25· · · ·Q· · Using that same definition, what is the lowest
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`·1· ·percentage efficiency that you would have expected among
`·2· ·nebulizers in 2006?
`·3· · · ·A· · Well, let me be very specific in my answer
`·4· ·because in the context of JESC and in the context of the
`·5· ·fact that this was the result of a very long-term
`·6· ·process, at least in where they were, as I mentioned
`·7· ·before, very specifically keen on developing rapid,
`·8· ·highly efficient nebulization of prostacyclin, I would
`·9· ·have expected that the efficiency of the nebulizer would
`10· ·be at least 50 percent.
`11· · · ·Q· · I think you gave me some background there
`12· ·first, but let me make sure I understand.
`13· · · · · · Using the same definition as in Gessler 2001,
`14· ·what is the lowest percentage of efficiency you would
`15· ·have expected among nebulizers in 2006?
`16· · · ·A· · I don't have an answer for that.· I'm just
`17· ·saying that in the context of the JESC and all of the
`18· ·work that was coming out of Gessler, I would have
`19· ·expected that the continuous ultrasonic nebulizer would
`20· ·be in the higher end of the efficiencies, and I would
`21· ·have said it would be higher than 50 percent or it would
`22· ·be at least 50 percent.
`23· · · · · · MR. DYKHUIS:· Mr. Ortiz, if you could please
`24· ·share EX 1062.
`25· ·///
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`·1· · · · · · (Exhibit 1062 was marked for
`·2· · · · · · identification and attached hereto.)
`·3· ·BY MR. DYKHUIS:
`·4· · · ·Q· · Dr. Gonda, let me know when you have that
`·5· ·exhibit pulled up.· Okay?
`·6· · · ·A· · I do have it.
`·7· · · ·Q· · Exhibit 1062 is called Ultrasonic Versus Jet
`·8· ·Nebulization of Iloprost in Severe Pulmonary
`·9· ·Hypertension and the first thing is author is T.
`10· ·Gessler.
`11· · · · · · Is this exhibit the Gessler article we were
`12· ·just discussing, Dr. Gonda?
`13· · · ·A· · Yes, it is.
`14· · · ·Q· · In the abstract, you see there's a second
`15· ·paragraph.· It says, "The physical features of the jet
`16· ·nebulizer system and the ultrasonic nebulizer,
`17· ·Multisonic Compact, were characterized."
`18· · · · · · Did I read that right?
`19· · · ·A· · Yes.
`20· · · ·Q· · So the ultrasonic nebulizer considered in this
`21· ·paper was the Multisonic Compact; correct?
`22· · · ·A· · Yes.· I can -- yes.· Correct.
`23· · · · · · MR. DYKHUIS:· Okay.· Mr. Ortiz, if you could
`24· ·share the document that is tab six, please.
`25· ·///
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`·1· · · · · · (Exhibit 2100 was marked for
`·2· · · · · · identification and attached hereto.)
`·3· · · · · · THE WITNESS:· I can see that.
`·4· ·BY MR. DYKHUIS:
`·5· · · ·Q· · Tab 6 states, "Multisonic Inhaling with
`·6· ·ultrasonic Infracontrol Instructions for Use."· It's a
`·7· ·29-page document.
`·8· · · · · · Dr. Gonda, in preparing your reply declaration,
`·9· ·did you review or consider this document identified as
`10· ·Multisonic Inhaling with Infracontrol Instructions for
`11· ·Use?
`12· · · · · · MR. DAVIES:· Objection.· Scope.
`13· · · · · · THE WITNESS:· I don't recall seeing this
`14· ·document before.
`15· · · · · · MR. DAVIES:· And, Counsel, I'm also going to
`16· ·object to the exhibit as being new evidence, which runs
`17· ·against the board's recent order.
`18· · · · · · MR. DYKHUIS:· I'm sorry?
`19· · · · · · MR. DAVIES:· I'm also objecting to the exhibit
`20· ·as new evidence that the board instructed should not be
`21· ·presented.
`22· · · · · · MR. DYKHUIS:· Okay.· I understand you have your
`23· ·objection, Counsel.· Thank you.
`24· · · ·Q· · My question for you, Dr. Gonda:· Your reply
`25· ·declaration doesn't cite this Multisonic manual;
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`·1· ·correct?
`·2· · · ·A· · Not as far as I remember.
`·3· · · ·Q· · Do you see that there's an image on the first
`·4· ·page of "Multisonic Instructions for Use," showing the
`·5· ·nebulizer on the left-hand side?
`·6· · · · · · MR. DAVIES:· Counsel, I'm going to object as to
`·7· ·scope and I'm going to object to the exhibit as new
`·8· ·evidence in contravention of the court's order.
`·9· · · · · · He said he's not relied on this in any way.
`10· ·It's not cited in his declaration.
`11· ·BY MR. DYKHUIS:
`12· · · ·Q· · Dr. Gonda, do you see that image on the
`13· ·left-hand side of the page?
`14· · · ·A· · This is the page --
`15· · · · · · MR. DAVIES:· Same objection, Counsel.
`16· · · · · · MR. DYKHUIS:· If you want, Counsel, do you want
`17· ·to just make a standing objection to deal with the
`18· ·questions I have on this exhibit?
`19· · · · · · MR. DAVIES:· No.· We can go off the record and
`20· ·discuss this.· But as you know, you blocked your witness
`21· ·from testifying on evidence that you believe was new on
`22· ·a prior invention of Dr. Wyman.· I'm not -- do you have
`23· ·a position on why this would not be in contravention of
`24· ·the PTAB's order on the introduction of new evidence?
`25· · · · · · MR. DYKHUIS:· Well, it's actually -- it's
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`·1· ·getting to the bases for and the evidence for
`·2· ·Dr. Gonda's opinions as were cited in his declaration.
`·3· · · · · · MR. DAVIES:· And the Gessler publication was
`·4· ·cited by your witness, Dr. McConville, I believe;
`·5· ·correct?
`·6· · · · · · MR. DYKHUIS:· I don't remember to be quite
`·7· ·honest.
`·8· · · · · · MR. DAVIES:· Well, in this sentence, it says it
`·9· ·is.· And we can go off the record and have this
`10· ·discussion.· But in my opinion, this is in contravention
`11· ·of the court's orders presenting new evidence.
`12· · · · · · MR. DYKHUIS:· Okay.· I disagree.· And we
`13· ·haven't filed it in any papers with the court, with the
`14· ·PTAB yet.· It hasn't been filed.· Okay?· It might get
`15· ·filed.· It might not.
`16· · · · · · I suppose my question for you is -- and if we
`17· ·have to go off the record, we can.· I'm not going to be
`18· ·here for a half an hour.· If we can just get through the
`19· ·questions, you can make your objections if you want.
`20· ·You can always try to exclude whatever evidence you
`21· ·think is improper.· I've got a limited set of questions
`22· ·I'd like to get through before Dr. Gonda's time runs out
`23· ·today.
`24· · · · · · MR. DAVIES:· All right.· If you press on this
`25· ·issue, I'm going to instruct him not to answer on this.
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`·1· ·I don't see any way that this is not new evidence.
`·2· · · · · · MR. DYKHUIS:· You're going to instruct him not
`·3· ·to answer on the basis of scope?· Are you going to go to
`·4· ·the board and seek a protective order or are you going
`·5· ·to instruct to answer on a basis other than privilege?
`·6· · · · · · MR. DAVIES:· I stated in my opinion, the court
`·7· ·ordered that there was not to be new evidence presented
`·8· ·in your reply.
`·9· · · · · · MR. DYKHUIS:· Okay.
`10· · · · · · MR. DAVIES:· We made this specific issue of you
`11· ·guys trying to introduce new evidence as exhibits in
`12· ·these depositions.· That was raised a concern with the
`13· ·court.· In my opinion, this is new evidence.
`14· · · · · · MR. DYKHUIS:· Okay.· We haven't said it in the
`15· ·reply yet.· We may or may not.· I hear --
`16· · · · · · MR. DAVIES:· But you're eliciting his testimony
`17· ·on this, Art.
`18· · · · · · MR. DYKHUIS:· Okay.· So --
`19· · · · · · MR. DAVIES:· That's evidence; right?
`20· · · · · · You've asked him if he's seen it.· He has not.
`21· ·He has not considered it in offering his opinion.· If
`22· ·you have an opinion as to why this is not new evidence,
`23· ·then you can present that.
`24· · ·