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`·1· · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`· · ·AQUESTIVE THERAPEUTICS· · · )
`·4· ·INC.,· · · · · · · · · · · ·)
`· · · · · · · · · · · · · · · · ·)
`·5· · · · · · · Petitioner,· · · )· Case No.
`· · · · · · · · · · · · · · · · ·)· IPR2019-00451
`·6· · · · vs.· · · · · · · · · · )
`· · · · · · · · · · · · · · · · ·)· Patent No.
`·7· ·NEURELIS, INC.,· · · · · · ·)· 9,763,876
`· · · · · · · · · · · · · · · · ·)
`·8· · · · · · · Patent Owner.· · )
`· · ·--------------------------· )
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`13· · · · · · · · ·PTAB CONFERENCE CALL
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`14· · · · · · · Tuesday, February 11, 2020
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`23· ·Reported by:
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`24· ·Stacey L. Daywalt
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`25· ·JOB NO. 176956
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`·1· · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3
`· · ·AQUESTIVE THERAPEUTICS· · · )
`·4· ·INC.,· · · · · · · · · · · ·)
`· · · · · · · · · · · · · · · · ·)
`·5· · · · · · · Petitioner,· · · )· Case No.
`· · · · · · · · · · · · · · · · ·)· IPR2019-00451
`·6· · · · vs.· · · · · · · · · · )
`· · · · · · · · · · · · · · · · ·)· Patent No.
`·7· ·NEURELIS, INC.,· · · · · · ·)· 9,763,876
`· · · · · · · · · · · · · · · · ·)
`·8· · · · · · · Patent Owner.· · )
`· · ·--------------------------· )
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`13· · · · · · · · ·PTAB CONFERENCE CALL
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`14· · · · · · · Tuesday, February 11, 2020
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`23· ·Reported by:
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`24· ·Stacey L. Daywalt
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`25· ·JOB NO. 176956
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`·3· · · · · · · · · · · · ·Tuesday, February 11, 2020
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`·4· · · · · · · · · · · · ·4:03 p.m.
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`·6
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`·7· · · · · · · PTAB Conference Call, held before
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`·8· ·Administrative Patent Judges Jamie T. Wisz,
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`·9· ·Jon B. Tornquist and Zhenyu Yang, before Stacey
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`10· ·L. Daywalt, a Court Reporter and Notary Public
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`11· ·of the District of Columbia.
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`·1· ·A P P E A R A N C E S:
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`·2· ·(All appearances are telephonic)
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`·3
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`·4· · · · HOFFMANN & BARON
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`·5· · · · Attorneys for Petitioner
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`·6· · · · · · · 6 Campus Drive
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`·7· · · · · · · Parsippany, New Jersey 07054
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`·8· · · · BY:· ·MICHAEL CHAKANSKY, ESQ.
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`·9· · · · · · · DANIEL SCOLA, JR., ESQ.
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`10· · · · · · · MATTHEW SOLOW, ESQ.
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`12· · · · WILSON SONSINI GOODRICH & ROSATI
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`13· · · · Attorneys for Patent Owner
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`14· · · · · · · 1700 K Street NW
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`15· · · · · · · Washington, DC 20006
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`16· · · · BY:· ·RICHARD TORCZON, ESQ.
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`17· · · · · · · JEFFREY GUISE, ESQ.
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`18· · · · · · · LORELEI WESTIN, ESQ.
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`19· · · · · · · NATHANIEL LEACHMAN, ESQ.
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Hi,
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`·3· ·everyone.· Good afternoon.· This is Judge Wisz.
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`·4· · · · · · · With me on the line are
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`·5· ·Judge Tornquist and Judge Yang.
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`·6· · · · · · · This is a conference call for
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`·7· ·IPR2019-00451.
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`·8· · · · · · · And do we have Petitioner on the
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`·9· ·line?
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`10· · · · · · · MR. CHAKANSKY:· Yes, you do, Your
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`11· ·Honor.· Michael Chakansky, Daniel A. Scola and
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`12· ·Matthew Solow.
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`13· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
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`14· ·Thank you.
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`15· · · · · · · And is Patent Owner on the line?
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`16· · · · · · · MR. GUISE:· Yes.· This is Jeff Guise
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`17· ·with Wilson Sonsini.
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`18· · · · · · · With me is Rick Torczon, Nate
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`19· ·Leachman and Lori Westin, I believe.
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`20· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Thank
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`21· ·you.
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`22· · · · · · · And is there a court reporter on the
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`23· ·line?
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`24· · · · · · · MR. TORCZON:· There is, Your Honor.
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`25· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Great.
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· · · · · · · And who ordered the court reporter?
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`·3· · · · · · · MR. TORCZON:· The Patent Owner
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`·4· ·ordered the court reporter, and we intend to
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`·5· ·submit a transcript promptly after this call.
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`·6· · · · · · · ADMINISTRATIVE PATENT JUDGE:
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`·7· ·Perfect.· That's what I was going to ask, so
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`·8· ·thank you very much.
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`·9· · · · · · · So we understand that this call was
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`10· ·requested by Patent Owner to request
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`11· ·authorization to file a motion to strike.
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`12· · · · · · · And so Patent Owner, please go ahead
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`13· ·and tell us what material you're looking to
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`14· ·strike and why you believe such a motion is
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`15· ·justified.
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`16· · · · · · · MR. TORCZON:· Thank you very much,
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`17· ·Your Honor.
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`18· · · · · · · This is Richard Torczon.· I'll be
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`19· ·speaking for Neurelis in the call.
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`20· · · · · · · The basic point here is that
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`21· ·substituting in a new expert without warning
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`22· ·this late is prejudicial.
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`23· · · · · · · This is not an example where the --
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`24· ·Aquestive has demonstrated that their original
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`25· ·expert is unavailable or unwilling to testify
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`·2· ·again, nor is this an example where, as they've
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`·3· ·indicated, they are just supplying a new expert
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`·4· ·to address a specific issue.· They suggest it's
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`·5· ·long-felt need.· But in fact, this is a
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`·6· ·complete substitution of experts for all
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`·7· ·positions.
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`·8· · · · · · · The new expert does not even commit
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`·9· ·to or elaborate on the original expert
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`10· ·Dr. Peppas's testimony.· We shouldn't have to
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`11· ·guess at what the correlation between the
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`12· ·positions of the original declarant and the
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`13· ·current declarant are.· Neither should the
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`14· ·Board.
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`15· · · · · · · Dr. Wermeling, the substitute
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`16· ·declarant, assiduously avoids discussing
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`17· ·Dr. Peppas's testimony except to embrace his
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`18· ·ultimate conclusions, which wouldn't be a
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`19· ·proper focus for expert testimony anyway.
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`20· · · · · · · And the lack of notice in this case
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`21· ·is particularly prejudicial.· Aquestive had
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`22· ·months to prepare for our expert.· We will only
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`23· ·have a few weeks to prepare to cross-examine
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`24· ·their expert.
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`25· · · · · · · On the facts of this specific case,
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`·2· ·it's troubling because Dr. Wermeling has had
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`·3· ·past dealings with both Neurelis officials and
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`·4· ·with our expert, each of whom have
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`·5· ·independently indicated that Wermeling has
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`·6· ·given them the opposite positions in past
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`·7· ·dealings.
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`·8· · · · · · · Because the critical date here is 12
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`·9· ·years ago, we are scrambling to look for
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`10· ·supporting impeaching documents and potentially
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`11· ·disqualifying documents.· But once again, the
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`12· ·surprise nature of this, the fact that they
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`13· ·gave no warning that this was going to happen,
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`14· ·really puts us in a tight spot, plus the sheer
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`15· ·volume of testimony and exhibits.· Given the
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`16· ·short time to respond, the limited number of
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`17· ·pages and the inability to provide countering
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`18· ·testimony to their new positions at this point
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`19· ·or to amend the claims is significantly
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`20· ·prejudicial.
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`21· · · · · · · As an example of a new argument,
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`22· ·Dr. Peppas admitted that he was not aware of
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`23· ·any ethanol benzyl alcohol mixtures in this
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`24· ·field.· All of a sudden, we are getting this
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`25· ·for the first time in a reply declaration that
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`·2· ·should have been in the original petition.· But
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`·3· ·that's one of many examples.
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`·4· · · · · · · Plus, as the Board knows, we
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`·5· ·continue to maintain that there was never an
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`·6· ·incorporation challenge in the original
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`·7· ·petition.· So any testimony trying to plug that
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`·8· ·gap at this point is going to be new testimony
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`·9· ·or is going to be testimony on a new issue
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`10· ·which they didn't raise.
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`11· · · · · · · To the extent that it's just being
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`12· ·offered to knock down positions that Neurelis
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`13· ·has had to take, it is an improper burden
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`14· ·shift.
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`15· · · · · · · And so this is a classic example of
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`16· ·new theory, as is their new basis for ethanol
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`17· ·benzyl alcohol mixtures.
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`18· · · · · · · So because of all this, we actually
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`19· ·think the entire declaration and any testimony
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`20· ·or any reference to it in the reply brief
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`21· ·should be struck.
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`22· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
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`23· ·Thank you.
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`24· · · · · · · Petitioner, would you like to
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`25· ·respond?
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· · · · · · · MR. CHAKANSKY:· Yes, Your Honor.
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`·3· ·It's Michael Chakansky.· I'll be speaking on
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`·4· ·behalf of Petitioner.
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`·5· · · · · · · To begin with, we are not
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`·6· ·substituting an expert.· Dr. Peppas is still in
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`·7· ·this case.· We have Dr. Wermeling, who is being
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`·8· ·responsive to arguments made in Patent Owner's
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`·9· ·response and the latest papers, as well as the
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`10· ·decision.· And he need not address every one of
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`11· ·the paragraphs in Dr. Peppas's because he's
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`12· ·here to simply rebut arguments brought by
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`13· ·Patent Owner.
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`14· · · · · · · Additionally, it's kind of strange
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`15· ·to hear counsel argue that the number of
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`16· ·exhibits or the page number is relevant, when
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`17· ·in a very similar IPR where they represented
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`18· ·the Petitioner, I quote:· "The page count and
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`19· ·number of exhibits in their expert declaration
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`20· ·are irrelevant, and the Federal Circuit has
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`21· ·allowed declarations by new experts."· This is
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`22· ·in IPR2017-1528 in response to a motion to
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`23· ·strike by Patent Owner.
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`24· · · · · · · In that case Petitioner went ahead
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`25· ·and submitted four new declarants with its
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`·2· ·reply, including one by a Dr. Langer, who was
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`·3· ·world-renowned like Dr. Peppas, and for the
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`·4· ·first time, without notice apparently, and a
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`·5· ·petition to support the motion to strike.
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`·6· · · · · · · The Board went ahead and den- -- and
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`·7· ·finding the claims unpatentable, denied the
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`·8· ·motion to strike, allowing in the reply as well
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`·9· ·as the declaration of their expert.· And this
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`10· ·was upheld by the Court of Appeals for the
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`11· ·Federal Circuit recently, in November of last
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`12· ·year, in a case called Sanofi versus Mylan.
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`13· · · · · · · And so we find that the case law
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`14· ·supports our position that we have the right to
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`15· ·present evidence in order to respond and rebut
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`16· ·arguments, that the fact that it's a different
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`17· ·expert is of no consequence and is irrelevant.
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`18· · · · · · · In the case that I've just referred
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`19· ·to, the IPR, that expert, Dr. Langer, there was
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`20· ·an objection that he submitted something like
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`21· ·60 exhibits along with his testimony.
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`22· · · · · · · We needed the exhibits because -- to
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`23· ·cover in part an argument that the other side
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`24· ·made to long-felt need covering an expanse of
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`25· ·30 years.· We've filled in the gaps with our
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`·2· ·testimony from Dr. Wermeling.
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`·3· · · · · · · Also, there were many, many
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`·4· ·arguments that we needed to address, and we
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`·5· ·did.
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`·6· · · · · · · Additionally, the argument about
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`·7· ·benzyl alcohol and ethyl alcohol, Dr. Peppas
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`·8· ·may have testified -- I'm not sure he did or
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`·9· ·didn't -- that he was unaware of the use of
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`10· ·benzyl alcohol with ethanol in an intranasal
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`11· ·solution that was emanative to humans. I
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`12· ·believe Dr. -- the expert for Patent Owner,
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`13· ·Dr. Gizurarson, also testified.
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`14· · · · · · · Well, Dr. Wermeling, who's
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`15· ·experienced in that area, experienced with
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`16· ·benzodiazepine, has dealt with developing these
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`17· ·things, was able to point us in the direction
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`18· ·to the fact that it was used by EMS workers
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`19· ·throughout the country in connection with the
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`20· ·use intranasally of diazepam IV and other
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`21· ·benzodiazepine IV solutions which contains
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`22· ·benzyl alcohol and ethanol, and that addressed
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`23· ·the long-felt need.· And that's one of the
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`24· ·secondary considerations they brought up, and
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`25· ·we're allowed to submit evidence for it.
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`·2· · · · · · · Additionally, we proffered, in both
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`·3· ·the petition as well as in Dr. Peppas's
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`·4· ·declaration, to the fact that our reference
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`·5· ·was -- had an early effective filing date
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`·6· ·before the effective filing date of Patent
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`·7· ·Owner's patent because the provisional
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`·8· ·application, the '558 application, did not
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`·9· ·reference alka glycoside.· And that's in this
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`10· ·case.
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`11· · · · · · · At that point the burden went over
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`12· ·to Patent Owner to show why it did support the
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`13· ·effective filing date.· And in that respect,
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`14· ·Patent Owner was able to ask Dr. Peppas whether
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`15· ·or not alka glycoside appears in this
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`16· ·reference, the Sigma reference, that was
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`17· ·incorporated by reference.
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`18· · · · · · · And Dr. Peppas said, yes, alka
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`19· ·glycosides are there.· What's not mentioned is
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`20· ·it's among about 150 other things.
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`21· · · · · · · Okay.· And in his petition -- in his
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`22· ·declaration, Dr. Peppas also testified the
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`23· ·combination of ethanol and benzyl alcohol, on
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`24· ·the other hand, as a solvent for
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`25· ·pharmaceuticals is very well-known, going back
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`·2· ·to the 1970s.· And that happens to be a true
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`·3· ·statement.
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`·4· · · · · · · And in any event, if Your Honors --
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`·5· ·and then finally -- excuse me -- we already
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`·6· ·have a sur-reply schedule.· We already have a
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`·7· ·date where, if necessary, Dr. Wermeling can be
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`·8· ·deposed.· He's available on that date.· Patent
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`·9· ·Owner will also be able to go ahead and make
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`10· ·arguments at oral argument.
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`11· · · · · · · And basically, Patent Owner's only
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`12· ·entitled to notice and the opportunity to
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`13· ·respond.
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`14· · · · · · · And in this trial, Petitioner is
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`15· ·allowed to rebut and respond to arguments made
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`16· ·by the Patent Owner, and that's what we've
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`17· ·done.· Thank you.
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`18· · · · · · · MR. TORCZON:· Your Honor, this is
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`19· ·Rick Torczon.· If I may?
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`20· · · · · · · Your Honor?
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`21· · · · · · · ADMINISTRATIVE PATENT JUDGE
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`22· ·TORNQUIST:· Sure.
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`23· · · · · · · This is Judge Tornquist stepping in.
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`24· ·Judge Wisz dropped off the call just briefly,
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`25· ·but she'll be right back on.
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`·2· · · · · · · So why don't you -- we're going to
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`·3· ·have a transcript.
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`·4· · · · · · · Why don't you go ahead and briefly
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`·5· ·respond.
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`·6· · · · · · · MR. TORCZON:· Okay.· First of all,
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`·7· ·I'd like to address the Sanofi/Mylan precedent.
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`·8· ·Completely different case.
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`·9· · · · · · · For one thing, Aquestive's counsel
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`10· ·neglected to note that the primary technical
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`11· ·expert, Dr. Yalkowsky, not only submitted a
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`12· ·declaration with the petition but also
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`13· ·submitted a declaration with the reply.· So we
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`14· ·had continuity of the same expert on the same
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`15· ·issue.
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`16· · · · · · · The fact that an additional
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`17· ·technical expert was brought in to address
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`18· ·additional issues is not that surprising.
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`19· · · · · · · He also mentioned several other
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`20· ·experts but neglected to note that all of those
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`21· ·were addressing testimony from Sanofi's
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`22· ·secondary considerations experts.
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`23· · · · · · · And so once again, the testimony of
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`24· ·the additional experts was limited to
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`25· ·additional points.· That's not the case here.
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`·2· · · · · · · What we didn't hear from Aquestive
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`·3· ·is that they're willing to limit
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`·4· ·Dr. Wermeling's testimony to the specific issue
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`·5· ·that they say is the only reason they put in an
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`·6· ·additional expert, and that is to address
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`·7· ·long-felt need.· Had they done that, this would
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`·8· ·be a very different case, but they haven't
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`·9· ·offered to do that.
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`10· · · · · · · As far as -- well, I think that
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`11· ·probably pretty much covers it.
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`12· · · · · · · There are a lot of other issues.· We
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`13· ·disagree with Mr. Chakansky's characterization
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`14· ·of the record to date.
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`15· · · · · · · And certainly, again, it is highly
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`16· ·prejudicial.· They haven't identified a single
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`17· ·case where somebody has been able to wholesale
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`18· ·substitute an expert at this late in the
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`19· ·proceeding without something like a death
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`20· ·occurring.
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`21· · · · · · · So that would be the basic position.
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`22· · · · · · · Certainly if Your Honors deny the
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`23· ·motion, we will proceed, you know, under
`
`24· ·protest and go ahead and cross-examine.· But
`
`25· ·that's neither here nor there.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
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`Page 16
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· · · · · · · The fact that we are left with
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`·3· ·proceeding under prejudice doesn't make the
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`·4· ·prejudice somehow acceptable.
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`·5· · · · · · · MR. CHAKANSKY:· Your Honors, may I
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`·6· ·just speak for a minute?
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`·7· · · · · · · It's Michael Chakansky.
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`·8· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Yes,
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`·9· ·go ahead.
`
`10· · · · · · · MR. CHAKANSKY:· Okay.· Two things.
`
`11· · · · · · · One, the -- incorporation by
`
`12· ·reference is not the only thing that
`
`13· ·Dr. Wermeling is talking to.· There were many
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`14· ·other issues, as can be seen just by looking at
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`15· ·his declaration or at the reply, including
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`16· ·criticality, bioavailability, benzyl alcohol
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`17· ·combinations, motivation to combine,
`
`18· ·precipitation concerns.· I could go on.
`
`19· · · · · · · That being said, Patent Owner's
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`20· ·counsel has said that we haven't shown any case
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`21· ·that says that you can make a substitution
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`22· ·without an expert dying or being unavailable.
`
`23· ·I point out neither has Patent Owner provided a
`
`24· ·case saying that is a requirement for new
`
`25· ·evidence in the form of declaration testimony.
`
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`Page 17
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· · · · · · · Thank you.
`
`·3· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Yeah,
`
`·4· ·actually, I was going to ask the Patent Owner.
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`·5· · · · · · · Do you have a case to support your
`
`·6· ·position that a new expert is not proper in a
`
`·7· ·reply?
`
`·8· · · · · · · MR. TORCZON:· The only cases I've
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`·9· ·seen this allowed are cases where the expert's
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`10· ·died or moved overseas or somehow is otherwise
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`11· ·significantly unavailable.
`
`12· · · · · · · Again, given the way that the Board
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`13· ·has structured these proceedings, this last
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`14· ·round is very, very limited both in terms of
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`15· ·time and in terms of what we can do in
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`16· ·response.
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`17· · · · · · · If you substitute somebody in at the
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`18· ·last minute, it's just an invitation for game
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`19· ·playing.· So I submit that the precedent that
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`20· ·will be set here is the one Mr. Chakansky is
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`21· ·asking for, which is to let people drop in
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`22· ·total surprise witnesses at the end.
`
`23· · · · · · · I think it's also significant that
`
`24· ·he points out that in fact Dr. Wermeling does
`
`25· ·go well beyond the issue that the e-mail to the
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
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`Page 18
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· ·Board suggested was the point of his testimony,
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`·3· ·which was to address long-felt need, because he
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`·4· ·had the expertise that Dr. Peppas did not.
`
`·5· ·Instead, as Mr. Chakansky just has accurately
`
`·6· ·noted, Dr. Wermeling addresses all sorts of
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`·7· ·issues, including issues that Dr. Peppas either
`
`·8· ·did or should have addressed in his initial
`
`·9· ·petition.
`
`10· · · · · · · So yes, this is very much a
`
`11· ·substitution where there may just be incidental
`
`12· ·additional addressing of long-felt need.
`
`13· · · · · · · MR. CHAKANSKY:· Okay.
`
`14· · · · · · · Your Honors, we are not
`
`15· ·substituting -- this is Michael Chakansky.
`
`16· · · · · · · We are not substituting.· Dr. Peppas
`
`17· ·is still in here.· There's a case, Belvin, in
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`18· ·which the Petitioner had no declarant along
`
`19· ·with his petition, I believe, and if I remember
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`20· ·correctly, then went ahead and in reply first
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`21· ·put in a declarant.
`
`22· · · · · · · There is no surprise here.· When
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`23· ·there is a complaint made about the experience
`
`24· ·of the expert and where there's a complaint
`
`25· ·made about the experience actually in
`
`Neurelis - EX.2027
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`Page 19
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· ·benzodiazepine, as well as many arguments going
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`·3· ·to why there's no motivation to combine and we
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`·4· ·have a fact -- we have an expert who can
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`·5· ·address that directly, we're entitled to bring
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`·6· ·it in in connection with the reply.
`
`·7· · · · · · · We have the same grounds.· We are
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`·8· ·not changing the grounds.· We are not changing
`
`·9· ·the prior art.· We're relying on the grounds.
`
`10· ·We are merely going ahead and being responsive
`
`11· ·to the arguments that Patent Owner made.
`
`12· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`13· ·Thank you.
`
`14· · · · · · · And for Patent Owner, you did
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`15· ·request in your e-mail, in the alternative,
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`16· ·some additional pages in the sur-reply.
`
`17· · · · · · · How many additional pages do you
`
`18· ·think you would need in this case?
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`19· · · · · · · MR. TORCZON:· Well, given the
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`20· ·surprise, I don't know that additional pages
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`21· ·would be an adequate remedy here.
`
`22· · · · · · · I mean, in part, as I've said, we
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`23· ·don't have time to go and, you know, do the
`
`24· ·sort of research that we need to do to show
`
`25· ·that Dr. Wermeling isn't an inappropriate
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
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`Page 20
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· ·witness.
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`·3· · · · · · · As we pointed out, they've nearly
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`·4· ·doubled the volume of testimony in this case
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`·5· ·compared to what Dr. Gizurarson offered, so
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`·6· ·it's hard to imagine any number of pages that
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`·7· ·would undo that damage.
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`·8· · · · · · · I believe we're actually under word
`
`·9· ·count.· So doubling the word count -- not
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`10· ·doubling, but at least a 50 percent increase in
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`11· ·the word count would help, because we believe
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`12· ·that even with the short amount of time, we're
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`13· ·going to be able to get a lot out of
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`14· ·Dr. Wermeling at his cross-examination that we
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`15· ·will need to bring to the Board's attention, as
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`16· ·well as address sort of the spread that they've
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`17· ·done with this new witness in their reply.
`
`18· · · · · · · MR. CHAKANSKY:· And Your Honor --
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`19· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Sorry.
`
`20· ·Go ahead.
`
`21· · · · · · · MR. CHAKANSKY:· And Your Honors,
`
`22· ·essentially Neurelis brought this upon
`
`23· ·themselves by having so many issues, including
`
`24· ·secondary considerations along with the --
`
`25· ·including the long-felt need.
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`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
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`Page 21
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· · · · · · · We shouldn't be prejudiced.· We had
`
`·3· ·the word count in our reply.· And if they have
`
`·4· ·the same amount in their sur-reply, I think
`
`·5· ·that that's a balancing of the parties' rights
`
`·6· ·in this matter.
`
`·7· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Well,
`
`·8· ·may I ask you, would you object to that amount
`
`·9· ·of additional words that Patent Owner has
`
`10· ·requested?
`
`11· · · · · · · MR. CHAKANSKY:· Yes.· Yeah.
`
`12· ·50 percent is quite a lot, especially -- it's
`
`13· ·an extra 12 pages or so.
`
`14· · · · · · · I know it's a word count.
`
`15· · · · · · · You know, we'd be amenable to an --
`
`16· ·the equivalent of five extra pages.
`
`17· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`18· · · · · · · Unless anyone has anything else at
`
`19· ·this point, we're going to put you on a brief
`
`20· ·hold so we can confer.
`
`21· · · · · · · MR. CHAKANSKY:· Thank you, Your
`
`22· ·Honor.
`
`23· · · · · · · ADMINISTRATIVE PATENT JUDGE:· All
`
`24· ·right.· Thank you.
`
`25· · · · · · · (Recess was taken from 4:24 p.m. to
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
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`Page 22
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· ·4:34 p.m.)
`
`·3· · · · · · · ADMINISTRATIVE PATENT JUDGE:· This
`
`·4· ·is Judge Wisz.· Thank you for holding.
`
`·5· · · · · · · Are Patent Owner and Petitioner
`
`·6· ·still on the line?
`
`·7· · · · · · · MR. CHAKANSKY:· Yes, Your Honor.
`
`·8· · · · · · · MR. TORCZON:· Yes, Your Honor.
`
`·9· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`10· ·Thank you.
`
`11· · · · · · · So we're not going to authorize the
`
`12· ·motion to strike.· As you know, striking a
`
`13· ·portion or the entirety of a brief or an expert
`
`14· ·declaration is an exceptional remedy that the
`
`15· ·Board expects to be granted rarely.
`
`16· · · · · · · However, we would like a specific
`
`17· ·identification of what Patent Owner believes
`
`18· ·are the new arguments.
`
`19· · · · · · · And so what we would request is a
`
`20· ·joint filing by both parties.· We're
`
`21· ·envisioning two columns.· You know, the
`
`22· ·left-hand column could be Patent Owner where
`
`23· ·you identify by page and line number and
`
`24· ·paragraph number what you believe to be the new
`
`25· ·material.· And then the right-hand column could
`
`Neurelis - EX.2027
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`Page 23
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· ·be Petitioner's response to Patent Owner's
`
`·3· ·identification, Patent Owner's argument.
`
`·4· · · · · · · I think about five pages should be
`
`·5· ·sufficient for that.· But if for some reason it
`
`·6· ·seems like you need another page or two, let us
`
`·7· ·know.· That should be fine.
`
`·8· · · · · · · I think, just so you know, we will
`
`·9· ·not consider any new arguments in our final
`
`10· ·written decision.· So if we do agree that some
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`11· ·of these are new arguments, they will not be
`
`12· ·considered in the final written decision.
`
`13· · · · · · · We think perhaps two weeks for that
`
`14· ·filing.
`
`15· · · · · · · Does that -- would that work with
`
`16· ·Patent Owner and Petitioner?
`
`17· · · · · · · MR. CHAKANSKY:· Your Honor, you
`
`18· ·perceive like one week for Patent Owner to put
`
`19· ·together its list and then one week for us to
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`20· ·respond to them and then we submit one jointly?
`
`21· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Yes.
`
`22· · · · · · · MR. TORCZON:· Patent Owner can make
`
`23· ·that work.
`
`24· · · · · · · ADMINISTRATIVE PATENT JUDGE:
`
`25· ·Petitioner, does that work?
`
`Neurelis - EX.2027
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`Page 24
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`·1· · · · · · · · ·PTAB Conference Call
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`·2· · · · · · · MR. CHAKANSKY:· Oh, yes.
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`·3· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`·4· · · · · · · And then also we will granting an
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`·5· ·extra thousand words in the Patent Owner's
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`·6· ·sur-reply.
`
`·7· · · · · · · And so when -- both in filing that
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`·8· ·paper and in including the additional words,
`
`·9· ·you can just reference this call as the
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`10· ·authorization to do so.
`
`11· · · · · · · MR. TORCZON:· Will do, Your Honor.
`
`12· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`13· · · · · · · Are there any other issues that need
`
`14· ·to be addressed on this call?
`
`15· · · · · · · MR. CHAKANSKY:· Nothing from
`
`16· ·Petitioner right now.
`
`17· · · · · · · MR. TORCZON:· Nothing from Patent
`
`18· ·Owners, Your Honor.
`
`19· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`20· · · · · · · Well, thank you all very much.
`
`21· · · · · · · With that, this call is adjourned.
`
`22· · · · · · · (Time Noted: 4:37 p.m.)
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`23
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`24
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`25
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`·1· ·District of Columbia, to wit:
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`·2· · · · · · · I, Stacey L. Daywalt, a Notary
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`·3· ·Public of the District of Columbia, do hereby
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`·4· ·certify that the proceedings were recorded
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`·5· ·stenographically by me and this transcript is a
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`·6· ·true record of the proceedings.
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`·7· · · · · · · I further certify that I am not of
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`·8· ·counsel to any of the parties, nor an employee
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`·9· ·of counsel, nor related to any of the parties,
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`10· ·nor in any way interested in the outcome of
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`11· ·this action.
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`12· · · · · · · As witness my hand and Notarial Seal
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`13· ·this 11th day of February, 2020.
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`14
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`15
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`16· · · · · · ·____________________________________
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`17· · · · · · · Stacey L. Daywalt, Notary Public
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`18· · · · · · · My Commission Expires:· ·4/14/2021
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
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