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` L I Q U I D I A T E C H N O L O G I E S , I N C . ,
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`P e t i t i o n e r ,
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`v s .
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` U N I T E D T H E R A P E U T I C S C O R P O R A T I O N , )
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`P a t e n t O w n e r .
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`T E L E P H O N E C O N F E R E N C E
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`B O A R D :
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`M r . C h r i s t o p h e r K a i s e r
`M s . E r i c a F r a n k l i n
`M r . D a v i d C o t t a
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`P E T I T I O N E R :
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`www.veritext.com
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`Veritext Legal Solutions
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`IPR2021-00406
`United Therapeutics EX2104
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`Page 2
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`(Whereupon the conference call
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`commenced at 10:01 a.m. cst.)
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`JUDGE KAISER: This is a call in
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`IPR2021-00406. I'm Judge Kaiser. With me on the
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`line are Judges Franklin and Cotta as well.
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`Before we get started can we do a
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`rollcall to see who all is here. Let's start
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`with anyone here on behalf of Petitioner.
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`MS. KANNAPPAN: Good morning, your Honor.
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`This is Deepa Kannappan from Cooley, LLP, on
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`behalf of the Petitioner and with me is Jonathan
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`Davies also from Cooley, LLP. I just wanted to
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`alert your Honor that there is a court reporter
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`on the line that is transcribing and taking down
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`our appearances.
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`JUDGE KAISER: Okay. Thank you. Before I
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`go to Patent Owner, let me just state for the
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`record that whoever provided the court reporter
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`if you would please file the transcript of the
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`call as an exhibit whenever you get the
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`transcript back we would appreciate that.
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`MS. KANNAPPAN: Yes, your Honor. Petitioner
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`has the court reporter so we will do that.
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`JUDGE KAISER: Okay. Thank you. And then
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`Patent Owner.
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`MR. HOUSTON: Good morning, your Honor.
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`This is Michael Houston on behalf of Patent
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`Owner, United Therapeutics, and I believe my
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`colleague, Steve Maebius, should have dialed in
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`as well. Steve, are you there?
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`MR. MAEBIUS: Yes. Hi, this is Steve
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`Maebius.
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`JUDGE KAISER: Okay. Thank you. Is there
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`anyone else on the line who I didn't call on?
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`Okay. Thank you.
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`All right. So as I recall this call
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`was requested by Patent Owner to request
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`authorization to submit evidence, new evidence,
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`along with its sur-reply. Assuming I have that
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`right, I guess I will open the floor up to Patent
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`Owner first.
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`MR. HOUSTON: Yes, thank you, your Honor.
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`And that is correct. We did make this request.
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`The reason being, your Honor, that as part of
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`Petitioner's reply filed in this case a few weeks
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`ago, they submitted a significant amount of new
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`evidence, some 5 declarations and 44 exhibits.
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`And while our initial position is that
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`much of that new evidence is improper reply
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`evidence and was the subject of our message to
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`the Board in our subsequent filing identifying
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`what we believe to be the new and improper reply
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`evidence, we are under the impression that that
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`issue is not likely to be decided, the propriety
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`of that evidence is not likely to be decided or
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`ruled upon until the final written decision stage
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`of the case. And, therefore, to protect the
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`prejudice against us in case some or all of that
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`evidence is not struck, we feel the need to be
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`able to submit our own evidence in response to
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`Petitioner's submissions.
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`The evidence topic wise, your Honor,
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`mostly focuses on this issue of public
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`accessibility of two abstracts that are at issue
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`in the proceeding. And your Honor may recall
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`that we also -- the parties had a call to discuss
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`this in the context of Petitioner's request to
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`file supplemental information. So it has to do
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`with that same topic. We feel like a lot of
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`these arguments, new arguments and new evidence,
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`should have been part of the petition and so
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`that's why we objected to it, but nonetheless
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`this is the first time that we have seen a lot of
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`this -- these arguments and this evidence. And
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`so if it's not going to be struck, then we feel
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`like we should have a chance to respond to it
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`more fully than simply being able to depose their
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`witnesses and submit those deposition
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`transcripts.
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` JUDGE KAISER: Okay. I have a couple of
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`questions there. One is just a clarification.
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`So is it the volume of the reply evidence that is
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`sparking this request or is it something in the
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`nature of the evidence itself that makes it
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`different from sort of typical reply evidence?
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` MR. HOUSTON: So, your Honor, it's very much
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`the latter. So, you know, you have heard us
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`mention the volume just to kind of alert the
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`Board to that. So, no, the request was not based
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`on the volume. It's based on the content which
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`is, simply put, they have raised new theories of
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`public accessibility for these two abstracts, new
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`legal theories, beyond what was in their petition
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`and I have them summarized here. I'm happy to go
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`through those just to highlight for your Honor if
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`you want to hear what those are; but unless you
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`ask me I won't go into that level of detail, but
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`they have new theories and new evidence
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`supporting those theories which we have just
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`simply not had a chance to respond to up until
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`now.
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` JUDGE KAISER: Sure. I mean, I guess public
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`accessibility seems to me like without going off
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`and doing a lot of legal research because
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`sometimes these are more complicated than they
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`seem at first glance. It seems to me like an
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`issue of fact, right. I mean, I'm confused and
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`maybe you could just tell me at a very high level
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`what was the initial legal theory for public
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`accessibility and what's the new one that they've
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`changed to.
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` MR. HOUSTON: Sure, your Honor. And also
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`just to be clear, I don't think they have
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`abandoned sort of the what they initially put in
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`the petition. And so I just want to make clear
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`not that I think they have changed. You used the
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`word change there and I just want to clarify. So
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`they are keeping that theory, but adding a bunch
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`of new ones.
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` The new ones that they have added is
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`Page 7
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`now they have said that there should be a
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`presumption of public accessibility based on the
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`identity of the publishers. That was not in the
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`petition. They said that these abstracts should
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`be considered publicly available based on what
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`was presented and/or handed out physically at the
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`conference. That was not in the petition. They
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`said that now they have put in some evidence of
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`topic indexes and author indexes. None of that
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`evidence was in the petition. It wasn't -- in
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`other words, there was not an argument made in
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`the petition nor was the evidence in the
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`petition.
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` And then two more. Now they are
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`saying that there should be public accessibility
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`found based on the theory of there being two,
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`quote, research aids. So they have now cited two
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`new articles that cite the abstracts and have
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`argued that those should count as research aids
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`to establish public accessibility.
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` And then they have put in a bunch of
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`new date-stamp copies of the abstracts from
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`libraries that was the -- that was what we
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`pointed out in our Patent Owner response was not
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`Page 8
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`part of the petition and that's why we felt like
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`their argument failed in the petition and that
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`was the subject of the their motion to submit
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`supplemental information which the Board did not
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`allow, but now they have put that evidence in as
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`reply.
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` So there is roughly five -- I broke it
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`down into roughly five sort of categories of new
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`arguments and evidence that they have submitted,
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`your Honor.
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` JUDGE KAISER: Okay. All right. Thank you.
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`That helps front the issue a little bit. I have
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`to confess, you know, the reply isn't something
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`that I've dug into very much at this point and so
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`I appreciate you giving me your side of the
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`rundown there.
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` I guess my other question then is the
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`new evidence that you would like to submit with
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`the sur-reply, what's the nature of that evidence
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`and what is it that it shows in the way of sort
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`of rebutting these new arguments if I can use
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`that phrase.
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` MR. HOUSTON: Sure. Well, your Honor, I
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`guess I have a couple responses to that. First
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`is we are still scrambling. We're still trying
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`to reach out to people who can provide relevant
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`information whether that's about the details of
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`this conference, whether that's about these
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`research aids that they have now cited to,
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`whether it's about the author and topic indexes.
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`You know, we are still very much actively trying
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`to figure out how to respond to this and it's
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`very challenging because of the short timeframe
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`we have.
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` Number two, I'm not sure quite how to
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`-- obviously I want this to be with very much all
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`due to respect to the Board, but I also feel a
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`little hesitant to go into a lot of detail of
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`what we're thinking. I feel like that opens the
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`door to some of our work product which we, you
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`know, we're still formulating our ideas here.
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` But at a high level, at a high level,
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`your Honor, what I think I can say is we're -- we
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`think we should be able to respond to this in
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`full. We don't think there should be limits on
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`how we are able to respond, but I'll tell you at
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`a high level the types of things we are thinking
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`of.
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` There could be just new documentary
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`evidence whether that's new documents or just,
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`you know, could just be all types. There could
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`be some documents or testimony from the prior
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`proceeding that involve this issue. And
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`certainly we think that would be fair because
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`Liquidia is well aware of that information. They
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`cited some of the information from that prior
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`proceeding in their own papers. So we think we
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`should be able to put in some of the
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`counter-argument and evidence from that
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`proceeding as appropriate.
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` Also, your Honor, there was some
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`depositions taken of the witnesses that are
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`already involved in this case. They were taken
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`in the context of the litigation that the parties
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`are currently undergoing. So there's a parallel
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`litigation there with a trial coming up in late
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`March. So there were some depositions by
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`Liquidia of some of these witnesses where the
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`subject matter was not identical to what was
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`covered in the corresponding IPR depositions. So
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`we think there may be instances where we would
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`like to be able to cite that deposition testimony
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`or submit it and cite to it which again should
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`not be prejudicial to Liquidia since they were
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`the ones doing the deposing in the first place.
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` And then, your Honor, I think it
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`really should be up to and including fresh new
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`declarations from witnesses on our end. Whether
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`it's to talk about what happened at the
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`conference. Whether it's to talk about these
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`research aids. The, you know, what the affect or
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`import is of all these new date-stamped copies of
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`the articles that they submitted.
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` You know, so I think, your Honor, our
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`request is to have sort of unfortunately just as
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`if this were the Patent Owner response. I think
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`we should be able to submit whatever we might
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`have submitted in the Patent Owner response had
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`all this evidence been in the petition the way we
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`think it should have been. So I think that
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`that's our request, your Honor. Was that
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`responsive to your question?
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` JUDGE KAISER: Yes, I think I understand
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`what you're getting at. And I would like, you
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`know, an opportunity to kind of discuss those
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`things with the rest of the panel, but let me
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`hear from Petitioner first. I presume that, Miss
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`Kannappan, you oppose this request?
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` MS. KANNAPPAN: Correct, your Honor. And
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`this is the first time we're receiving the full
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`basis and what Patent Owner is actually looking
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`to include with their sur-reply. So some of this
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`I'm trying to respond to on the spot and I
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`apologize if it's not the most coherent.
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` But, for example, the points that they
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`point to from our reply are not new legal
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`theories of public accessibility, and in fact are
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`just factual support for the original positions
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`and are actually positions taken directly in
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`response to certain arguments raised in the
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`Patent Owner response. And as Patent Owner just
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`alluded to, there is a whole other set of papers
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`that the parties have filed for the Board to
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`consider on exactly what arguments in the Patent
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`Owner response the replies were responding to.
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` So, for example, the Patent Owner
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`response specifically argued that because these
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`abstracts showed up in supplements, they would
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`not be published within a year of the conference
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`taking place. And that was just not true based
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`Page 13
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`on the numerous date-stamped copies that
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`Petitioner submitted with its reply. And, in
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`fact, Patent Owner has known about those exhibits
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`since at least the motion for supplemental
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`information and has known about all of these
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`arguments from the parallel district court
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`proceedings for months now and they chose to just
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`ask about this last week.
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` So we think that the cries for
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`prejudice are not real quite frankly. And, in
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`fact, we tried to ask their witnesses, Miss
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`Weiman, Dr. Waxman and Dr. Merconval (phonetic)
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`about some of these issues in their IPR
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`depositions and Patent Owner actively would not
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`allow us to with the date-stamped copies.
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` And then for the other issue that we
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`did ask about, for example, we asked Dr. Waxman
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`about the conferences that these abstracts were
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`presented at and if they were well-attended and
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`he agreed that they were. So it's unclear to us
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`what new documentary evidence or testimony would
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`establish the opposite. And as your Honor asked
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`them to identify what that evidence would be,
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`Patent Owner has still not really identified what
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`Page 14
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`that evidence is going to show that they couldn't
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`just make an argument in a sur-reply as would
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`normally be allowed.
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` So in summary, your Honor, nothing in
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`the reply evidence makes this case different.
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`It's in addition to the petition and responsive
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`to the POR is something that the petition or the
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`Patent Owner has been on notice for months now.
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` But we do ask if the Board was
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`inclined to grant Patent Owner's request, that we
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`as Petitioners be authorized to depose any
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`declarants as to those transcripts and if
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`possible to file a supplemental reply or
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`cross-examination remarks addressing arguments
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`related to new exhibits that are not normally
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`authorized by sur-reply.
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` JUDGE KAISER: Okay. I think I get that. I
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`guess one question I have for you, Miss
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`Kannappan, is the precedential decision in Julio
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`seems to at least contemplate if not outright
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`authorize, you know, Petitioner to do something
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`along the lines of what you've done here, right,
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`which is to in response to some argument that's
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`raised in the Patent Owner response to submit
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`Page 15
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`additional evidence with the reply sort of
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`expanding on their original theories.
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` But I guess my question is how far
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`does that go? What's your understanding of kind
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`of what are the limits on that? There's, you
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`know, certainly a sort of -- I can picture a set
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`of facts that's clearly acceptable, right, where
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`Petitioner brings in new things that just sort of
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`help bolster its original theories that everyone
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`was aware of and that just for whatever reason
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`weren't in the record to begin with.
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` And I can picture I think a set of
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`facts that is beyond the pale where Petitioner
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`really changes horses in midstream. But what's
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`the lines between those two extremes and how do
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`we know that what you're doing -- what you've
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`done so far is on the side of the line that
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`shouldn't give rise to some opportunity for
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`Patent Owner to respond?
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` MS. KANNAPPAN: Sure, your Honor. I think
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`what's helpful is to look at what the Board has
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`even put in the manual itself which is changing,
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`for example, like combinations of ground. That
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`falls on the side of change to theory that was
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`Page 16
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`essential to the petition being granted and that
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`would be beyond the pale.
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` But, for example, what's happening
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`here is that we have always said that these
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`abstracts were publicly accessible and in the
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`petition we pointed to the fact that they were
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`both presented at conferences. Based on the face
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`of the abstract it says that. And then also the
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`dates on the -- or the actual physical documents
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`that we already submitted with the petition. And
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`then Patent Owner raised specific reasons why
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`they thought those weren't enough and we
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`submitted evidence in response to those
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`arguments.
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` And so I guess a second category I
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`would add, your Honor, is if it's responsive to
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`Patent Owner's arguments, then it would also fall
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`on the side of -- allow evidence so long as it's
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`not a completely new theory that would vitiate
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`the petitioned grounds. Does that make sense?
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` JUDGE KAISER: Yes, I think I understand
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`that argument. Let me -- because I think I
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`sprang that question on you without posing it to
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`Mr. Houston. Mr. Houston, let me give you an
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`Page 17
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`opportunity to respond at least to that question
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`which is what is the dividing line, the right
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`dividing line, in your opinion between, you know,
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`Petitioner doing something that is an acceptable
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`expansion which clearly does exist in our rules
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`and an impermissible change that ought to give
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`rise to the sort of response that you're
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`suggesting here?
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` MR. HOUSTON: Sure, your Honor. So, first
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`of all, just acknowledge that this is a somewhat
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`nebulous issue with the Board. We see it arise
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`in many, many cases and many, many more
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`decisions. And so, you know, a lot of times
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`there is not a black and white answer.
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` But here I do think it's more clear in
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`that our Patent Owner response essentially took
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`the position what the petition's evidence of
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`public accessibility for these two documents. I
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`mean, keep in mind there is many, many priorate
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`references at issue in this proceeding; but as to
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`these two documents, we took the position that
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`the petition simply failed to show public
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`accessibility. And in those circumstances that's
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`where the Board and the Federal Circuit quite
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`Page 18
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`frankly has been more reluctant to let a party
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`come in and reply and fix that deficiency.
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` In other words, we should be allowed
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`to just say your petition didn't meet the burden.
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`And that doesn't -- that doesn't then give rise
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`to the ability for a redo. And we certainly have
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`seen that sort of I would say decisionmaking
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`process especially in the context of citing the
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`contents of prior art where maybe the petition
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`focuses on a given embodiment in a reference when
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`it says the patent at issue is invalid over that
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`prior art. And when somebody points out a
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`problem with that embodiment, why it doesn't
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`invalidate the claims at issue. Then the
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`Petitioner points to a new embodiment in the same
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`reference and says, oh, look, this is part of our
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`same theory. It's the same art. We're still
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`saying the patents are invalid over it, but now
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`it's just another embodiment.
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` I think that is a pretty good analogy
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`for what's happening here, your Honor. And I
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`think where the Board can have some guidance in
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`terms of where to come out on this issue is we
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`have said that their initial sufficient evidence
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`Page 19
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`wasn't sufficient and now they have put in a lot
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`of new stuff, a lot of new arguments and new
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`evidence, and that's basically just fixing a hole
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`in the petition.
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` And, you know, while in some ways you
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`think, okay, it is responsive to our Patent Owner
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`response, but I think where we just say your
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`evidence is inadequate, that shouldn't be viewed
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`and typically hasn't been viewed as an invitation
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`to now go fix the problem as opposed to an
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`argument that would be more allowable which is to
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`argue why the original evidence was sufficient.
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`If they limited themselves to that, that would be
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`fair game for a reply. But the new argument, new
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`evidence, is where we think it's out of bounds.
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` The only other thing I would add, your
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`Honor, is that they did try to submit a lot of
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`this evidence as supplemental information and
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`they couldn't convince the Board that the
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`information couldn't have been presented as part
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`of the petition and so that request was denied.
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`And we think that that same language really
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`applies to the reply and we're taking that
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`position out of what the Trial Practice Guide
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`Page 20
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`indicates.
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` I think we mentioned it in one of our
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`e-mails, but I'll just mention it here for
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`completeness. On page 74 of the Trial Practice
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`Guide it talks about, you know, reply or
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`sur-reply that raise a new issue or belatedly
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`presents evidence, you know, is not -- is not to
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`be considered. Won't be considered. And so we
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`think that that's exactly what's happening here
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`just for the same reasons that the supplemental
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`information request was denied because it was
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`just belated evidence and I think that's exactly
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`what is happening here, your Honor.
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` So we do think the Trial Practice
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`Guide helps speak to this point to help the
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`Board's, you know, analysis of the issue.
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` JUDGE KAISER: Okay. I think I understand
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`the parties' positions here on both sides. So
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`what we're going to do is I'm going to ask the
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`parties and everyone on the call to hold the line
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`and the panel and I are going to go off and
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`discuss and we'll be back in a few minutes with
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`how we're going to go forward here.
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` (Whereupon a recess was taken.)
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` JUDGE KAISER: All right. Everybody we are
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`back from our deliberations. Let me just make
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`sure there are still people here representing
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`Petitioner.
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` MS. KANNAPPAN: Yes, your Honor. We're
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`still here.
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` JUDGE KAISER: Okay. And still someone here
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`from Patent Owner.
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` MR. HOUSTON: Yes, your Honor.
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` JUDGE KAISER: Okay. Thank you. So the way
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`that these proceedings are set up unfortunately
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`unlike in district court proceedings doesn't
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`allow us to keep the record open for as long as
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`it takes to get the job done. It requires us to
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`make a decision in a particular time which
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`requires us to have a hearing at a particular
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`time which requires us to close the record at
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`some point.
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` And the way that all the various
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`things that go into balancing the decision about
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`when to close the record have been resolved in
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`the main is what is set forward in the Trial
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`Practice Guide which is to -- in the mine-run of
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`cases place the end of things going into the
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`Page 22
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`record along with the Petitioner's reply and then
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`just permit Patent Owner an opportunity to
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`comment on Petitioner's reply evidence and to
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`make legal arguments regarding the state of the
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`record as it exists at that point without
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`submitting or generating new evidence to go along
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`with those arguments.
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` And given that it seems to us that the
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`way to resolve this is to look at the arguments
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`that the parties have already submitted about
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`whether the new evidence and arguments in the
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`reply -- or let me rephrase that. The allegedly
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`new arguments and evidence in the reply are
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`actually new or not and notwithstanding Patent
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`Owner's point that that won't happen until we sit
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`down to review the entire record at the time of
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`the hearing and thereafter, it seems like we've
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`got a way forward to resolve this which is to,
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`you know, if we agree with Patent Owner that this
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`stuff is new, then we're going to ignore it
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`because it's beyond the scope of things that
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`ought to be in the record and we'll say in the
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`final written decision that that's what we're
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`doing. And in this case there is no need for
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`Page 23
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`additional evidence to rebut what came in with
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`the reply.
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` And if we agree with Petitioner that
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`it's not new and it is an appropriate expansion
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`of the record on the original theories, then the
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`Trial Practice Guide would apply and there would
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`be no -- no right to submit additional rebuttal
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`evidence in that case. And those two scenarios
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`seem to cover the waterfront pretty well and so
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`we don't see a need to keep expanding the record
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`at this point beyond what's allowed in the Trial
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`Practice Guide which is to say, you know,
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`deposition testimony of any reply witnesses can
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`obviously be put in as well as any legal
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`arguments that are appropriate for the sur-reply.
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`But there is no -- no need for or no call for
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`additional evidence beyond what is called out
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`there.
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` So I think that makes things clear,
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`but -- and we will follow up with an order along
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`those lines. But to the extent that that sparks
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`any need for clarification, let me ask the
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`parties -- I'll start with Patent Owner. Is
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`there any need for me to clarify that any
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`Page 24
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`further?
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` MR. HOUSTON: I think I understand your
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`Honor's position. I guess there was one question
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`I would ask as a part of that. If we are
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`deposing their witnesses and we are covering
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`subject matter that's in the relevant declaration
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`that we are deposing them on and we feel like we
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`have some documents that are relevant to that
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`testimony and we want to put those documents in
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`front of the witness as we ask the witness
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`questions, I presume those documents by virtue of
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`being exhibits to the deposition, those would at
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`least get submitted as part of submitting the
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`deposition transcript? Is that your Honor's
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`understanding that that -- in other words --
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` JUDGE KAISER: In that situation -- I have
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`seen that situation come up before and I remember
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`having a fight over it and I honestly don't
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`remember how we ended up coming out.
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` Let me ask Petitioner, you know,
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`assuming we are talking about, you know,
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`documents that were actually, you know, presented
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`to a witness and the witness testified about, I
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`mean, it does seem like it would be hard to
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`Page 25
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`understand the testimony without any ability to
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`look at the document generally speaking. Would
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`you have any objection to those sorts of exhibits
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`going in?
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` MS. KANNAPPAN: Well, your Honor, just a
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`first question that that actually seems like a
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`bit of a runaround of what your Honor just
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`articulated. Because essentially the Patent
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`Owner could just put in whatever exhibits they
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`would have put with their sur-reply in front of
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`the witness and then be able to add it to their
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`record in that manner. And so if that's what's
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`happening, we would object both in the deposition
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`and to the general practice.
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` So I guess that is my initial
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`response. We don't want it to just be a
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`workaround of what your Honor's order just
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`specifically said they shouldn't do. If it's
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`exhibits that the -- oh, I'm sorry. Go ahead,
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`please.
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` JUDGE KAISER: That does -- you're right. I
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`mean, there is definitely some opportunity for
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`gamesmanship there. I think --
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` MR. HOUSTON: Your Honor, if I may, I'll
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`Page 26
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`just -- could I say -- make one comment on behalf
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`of Patent Owner is just that we understand what
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`Petitioner's concern is. There is not an
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`intention to use the depositions as a workaround.
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`Any evidence that we submit in that manner will
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`be relevant to the witness's testimony.
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` So, in other words, we're not just
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`going to put some random document in front of the
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`witness, ask them if they have seen it before and
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`regardless of what they say, we submit it as
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`evidence and start relying on it for all sorts of
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`reasons. That wasn't the nature of my question.
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`So if that helps, your Honor, that's not our
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`intention.
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` JUDGE KAISER: Sure. I mean, so I think
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`we'll reserve ruling on that. Why don't we wait
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`and see if it comes up. You know, if there are
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`things that, you know, that are -- that are
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`averted to in the deposition that are put before
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`the witness where we really need it in order to
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`understand what the witness's testimony is, I
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`think we will find a way to get those into the
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`record. But it's sort of difficult to say in the
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`abstract, you know, as a general principle we're
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