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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________________________________
`MODERNA THERAPEUTICS, INC., )
` ) Case No. IPR2018-00680
` Petitioner, ) Case No. IPR2018-00739
` ) Patent No. 9,404,127
`v. ) Patent No. 9,364,435
` )
`PROTIVA BIOTHERAPEUTICS, )
`INC., )
` )
` Patent Owner. )
` )
` ________________________________________________________
` TELEPHONIC VERBATIM REPORT OF PROCEEDINGS
` October 2, 2018
` Seattle, Washington
` ________________________________________________________
`
` Job Number: 148826
`
` Taken Before:
`
` Laura A. Gjuka, CCR #2057
` Certified Shorthand Reporter
`
`TSG Reporting - Worldwide 877-702-9580
`
`PROTIVA - EXHIBIT 2008
`Moderna Therapeutics, Inc. v. Protiva Biotherapeautics, Inc.
`IPR2018-00739
`
`
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`Page 2
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` A P P E A R A N C E S
` For the Petitioner:
` MICHAEL FLEMING, ESQ. (By Phone)
` MACLAIN WELLS, ESQ. (By Phone)
` Irell & Manella
` 1800 Avenue of the Stars
` Los Angeles, CA 90067
`
`
`
` For the Patent Owner:
` MICHAEL ROSATO, ESQ.
` SONJA GERRARD, ESQ.
` Wilson Sonsini Goodrich & Rosati
` 701 Fifth Avenue
` Seattle, WA 98104
`
`
`
` Also Present:
`
` RICHARD J. SMITH (By Phone)
`
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` PROCEEDINGS
` BE IT REMEMBERED that on the 2nd of October,
` 2018, 11:00 a.m., at 701 Fifth Avenue, Seattle,
` Washington, before LAURA A. GJUKA, CCR# 2057, Washington
` State Certified Court Reporter residing at University
` Place, authorized to administer oaths and affirmations
` pursuant to RCW 5.28.010.
` WHEREUPON the following proceedings were had,
` to wit:
` * * * * * *
`
` APJ SMITH: Is there a court reporter?
` MR. ROSATO: Hi, this is Mike Rosato that
` just joined on behalf of patent owner.
` APJ SMITH: Okay. My question was: Do we
` have a court reporter?
` MR. ROSATO: We do. Who is on the line
` right now?
` APJ SMITH: Well, let's start with the
` introductions. I just wanted to confirm that we have a
` court reporter first.
` So, Petitioner, please introduce yourself and all
` persons that are with you.
` MR. FLEMING: Yes, Your Honor. This is
` Mike Fleming. I represent the Petitioner. I don't
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` PROCEEDINGS
` believe there is anybody else on with me.
` MR. WELLS: Mike, it's Maclain Wells. I
` am on the line as well.
` MR. FLEMING: Okay, great.
` APJ SMITH: Okay. Patent owner
` introductions.
` MR. ROSATO: Good afternoon, Your Honor.
` This is Mike Rosato on behalf of patent owner, and I
` have with me Sonja Gerrard and, as I stated, a court
` reporter, and apologies if I wasn't recognizing voices
` there.
` APJ SMITH: Oh, that's fine.
` So just a few matters first, and then I'll open it
` up to the parties for any questions or issues that they
` would like to raise.
` I'm assuming that all parties are familiar with or
` are aware of the August trial practice guide update and
` also a recent update to the SOP 1 and 2?
` MR. FLEMING: Your Honor, this is
` Petitioner, and we are very well aware of those changes.
` APJ SMITH: Okay.
` MR. ROSATO: Yes, Your Honor. We are
` aware of those as well.
` APJ SMITH: Okay. Next question: Have
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` PROCEEDINGS
` there been any settlement discussions between the
` parties?
` MR. ROSATO: Not that I'm aware of,
` Your Honor. This is Mike Rosato.
` APJ SMITH: Okay. So I'll open it up to
` the parties. I'll ask the petitioner first whether you
` have any procedural questions, changes to the scheduling
` order, or any other matter that you would like to raise
` at this time?
` MR. FLEMING: Your Honor, we don't have
` any proposed changes to the schedule or have any
` questions, although we do reserve to do so in this -- in
` the future if it comes a time to arise. And of course
` we will follow the procedures that call for a conference
` call before doing so.
` APJ SMITH: Okay. Patent owner.
` MR. ROSATO: No specific motions. I have
` a couple of procedural issues of concern I would like to
` raise.
` APJ SMITH: Okay.
` MR. ROSATO: And I will start with the
` case, as we all know and are familiar with, the
` US Supreme Court recently issued its decision in the
` SAS Institute vs. Iancu case. And we're all coming up
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` PROCEEDINGS
` to speed on any changes in procedure in view of the SAS
` decision, so a couple questions in that regard.
` Your Honor mentioned the updated practice guide.
` That sort of goes to one of the questions, but our
` understanding is that that decision did not change the
` Board's rules regarding a proper scope of petitioner's
` reply materials, the patent owner response or, in other
` words, board rule 42.23, which addresses the proper
` scope of reply materials that is still in effect. Am I
` correct in that understanding?
` APJ SMITH: Yes, that's my understanding.
` Judge Snedden, do you have any thoughts on that?
` Judge Snedden?
` Okay. We'll see if we can get him to weigh in if he
` would like to.
` What was your other concern?
` MR. ROSATO: Okay. And we noted slightly
` different language in the revised trial practice guide,
` but they look about the same, and that is that it's
` still proper procedure before the Board that new
` evidence necessary to make out a prima facie case of
` unpatentability is material that would be considered
` outside the scope of a proper reply. And I'm comparing
` pages 48767 of the old practice guide, and then page 14
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` of the new practice guide. They look the same. But I
` think that's all still in effect unless I'm told
` otherwise.
` APJ SMITH: Yeah, if you're not seeing any
` change, there wouldn't be a change.
` MR. ROSATO: Okay. Well, thank you,
` Your Honor. I appreciate that.
` The next issue is more of a global issue, global in
` that it applies to both cases and a number of the
` grounds of challenge.
` But there are really just a number of instances
` we're -- I have to say, we're simply not clear as to the
` grounds of challenge that were presented in the petition
` materials or, alternatively, those instituted in the
` Board's decisions.
` And I know a number of these issues were raised in
` some detail in our preliminary response briefs. We do,
` however, still find ourselves searching for some
` clarity. And at this stage of the proceeding the main
` thing is we want -- you know, we certainly want to
` address the challenges, whatever they might be, and we
` do want to be responsive in the patent owner response
` materials, but to do so we do need to know precisely
` what we're responding to. And for many of the grounds,
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` this has proven difficult; in some cases impossible.
` I can give some examples, I don't need to go through
` every single one, although I'm happy to do so.
` APJ SMITH: Well, can I stop you, Counsel?
` That's really beyond the scope of today's call. I
` mean, we're here to talk about procedural matters and
` the institution decision's laid out the institution.
` And, you know, we've got the SAS case. And so I'm not
` in a position, nor will I give you any particular
` guidance there. That's really more of a substantive
` issue you're going to have to work out.
` MR. ROSATO: Understood, Your Honor. The
` questions I'm going to are procedural in nature. I
` understand your point on the substantive topics. The
` concerns I'm raising are procedural in nature. And
` primarily, you know, this is procedural to the extent
` that we want to be responsive. But it is important to
` note we are identifying issues of clarity that still
` persist, and this is going to persist.
` And we just want to make sure the Board is aware,
` everybody is aware, that there are a number of instances
` where we really do not know what the precise challenge
` is. That's important from a procedural standpoint
` coming into our patent owner response. It is, from our
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` perspective, important to note this does also raise a
` number of due process concerns. We're concerned about
` what looks to be sort of an open-book approach in --
` APJ SMITH: Counsel, let me interrupt you
` again. Again, you're going beyond the scope of this
` call.
` MR. ROSATO: Okay.
` APJ SMITH: I can't give you -- that's --
` you know, how you proceed is how you proceed.
` MR. ROSATO: Okay. So I guess the one
` remaining procedural concern then, I guess, is if there
` is a difference -- back to the SAS issue, if we're
` noticing a difference between the materials or the
` grounds that seem to be presented in the petition
` materials and what was stated in the institution
` decision or understanding of the SAS decision is that
` it -- that decision indicates the petitioner defines the
` scope of challenge. So that's what we should be
` responding to; is that a correct understanding of the
` procedure?
` APJ SMITH: Again, that's going beyond. I
` don't view that as a procedural issue. That's a
` substantive issue you have to address, if you care to
` address it, in your briefs.
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` MR. ROSATO: Okay. So am I understanding
` the suggestion that this is to be addressed in the
` patent owner response materials?
` APJ SMITH: I'm not telling you when and
` where to address it, if you want to address it.
` MR. ROSATO: Okay.
` APJ SMITH: Again, it just goes beyond the
` scope of this call.
` MR. ROSATO: Okay. I guess I read the
` scheduling order as flagging any procedural issues of
` concern and --
` APJ SMITH: I don't see that as a
` procedural issue, Counsel.
` MR. ROSATO: Okay.
` APJ SMITH: Any other questions?
` MR. FLEMING: No, Your Honor, not from
` Petitioner.
` MR. ROSATO: That's all we had.
` APJ SMITH: Okay. Petitioner, I believe
` you indicated you had a court reporter. I'm just
` reminding you that you need to file a copy of the
` transcript as soon as possible in these proceedings.
` MR. ROSATO: Will do.
` APJ SMITH: Okay, thank you.
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` MR. ROSATO: Thank you.
` APJ SMITH: We are adjourning.
` (Proceedings concluded at 11:10 a.m.)
`
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` C E R T I F I C A T E
` I, Laura Gjuka, a Certified Court Reporter in
` and for the State of Washington, residing at
` University Place, Washington, authorized to administer
` oaths and affirmations pursuant to RCW 5.28.010, do
` hereby certify;
` That the foregoing Verbatim Report of Proceedings
` was taken stenographically before me and transcribed
` under my direction; that the transcript is a full, true
` and complete transcript of the proceedings, including
` all questions, objections, motions and exceptions;
` That I am not a relative, employee, attorney or
` counsel of any party to this action or relative or
` employee of any such attorney or counsel, and that I am
` not financially interested in the said action or the
` outcome thereof;
` That upon completion of signature, if required, the
` original transcript will be securely sealed and the same
` served upon the appropriate party.
` IN WITNESS HEREOF, I have hereunto set my hand this
` 3rd day of October, 2018.
`
` ____________________________
` Laura Gjuka, CCR No. 2057
`
`TSG Reporting - Worldwide 877-702-9580
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`