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` PROCEEDINGS
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ------------------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ------------------------------------
` MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` v.
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
` --------------------------------
` IPR2018-01679 Patent No 8,882,486
` IPR2018-01680 Patent No. 9,526,844
` IPR2018-01682 Patent No. 9,526,844
` TELEPHONIC CONFERENCE
` June 19, 2019
`
`Reported by:
`Randi J. Garcia, RPR
`Job No. 162983
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` PROCEEDINGS
`
`June 19, 2019
`1:00 p.m.
`
`Telephonic Conference held before
`the Honorable PTAB Administrative Judges BART
`A. GERSTENBLITH, HYUN J. JUNG and JAMES A.
`TARTAL on June 19, 2019, held before Randi J.
`Garcia, RPR and Notary Public.
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` PROCEEDINGS
`A P P E A R A N C E S:
`WILSON SONSINI GOODRICH & ROSATI
`Attorneys for Petitioner
`1700 K Street NW
`Washington, DC 20006
`BY: RICHARD TORCZON, ESQ.
`NICOLE STAFFORD, ESQ., WES DERRYBERRY, ESQ.
`ELLIE STEINER, ESQ.,
`TASHA THOMAS, ESQ.
`
`WEIL GOTSHAL & MANGES
`Attorneys for Patent Owner
`767 Fifth Avenue
`New York, New York 10153
`BY: ELIZABETH WEISWASSER, ESQ.
`BRIAN CHANG, ESQ.
`
`FISH & RICHARDSON
`601 Lexington Avenue
`
`New York, NY 10022
`CARL RENNER, JOHN GOETZ, JOSHUA
`GRISWOLD, ESQ. and KENNETH DARBY, ESQ.
`
`Also Present: Jovial Wong, Esq., Pfizer
`
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` ADMINISTRATIVE JUDGE JUNG: This is
`IPR 2018-01670, 1676, 1678, 1679, 1682.
` THE REPORTER: Judge, can I have your
`name, please.
` ADMINISTRATIVE JUDGE JUNG: This is
`judge Jung. J-U-N-G.
` And the last thing we will talk about
`is 1680 between Mylan Pharmaceuticals and
`Sanofi-Aventis Deutschland.
` With me is Judge Gerstenblith and
`Judge Tartal.
` Counsel for petitioner, please
`introduce yourselves.
` MR. TORCZON: Good afternoon, your
`Honor, this is Richard Torczon for
`petitioner Mylan.
` As you can tell, we have a court
`reporter on the line and we plan to file a
`transcript promptly.
` Also, from Mylan is Nicole Stafford,
`Wes Derryberry, Tasha Thomas and Ellie
`Steiner. And counsel for Pfizer has also
`called in Jovial Wong.
` ADMINISTRATIVE JUDGE JUNG: Thank
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`you, Mr. Torczon. Make sure you file this
`transcript only in the cases I enumerated
`at the beginning. Is that understood?
` MR. TORCZON: Yes, your Honor.
` ADMINISTRATIVE JUDGE JUNG: Counsel
`for Patent Owner, please introduce
`yourselves.
` MS. WEISWASSER: Good afternoon,
`your Honor, this is Elizabeth Weiswasser.
`I'm at Weil. I'm lead counsel for the
`Patent Owner.
` And with me on the line also from
`Weil is backup counsel Brian Chang. I'm
`also joined on the call by a number of
`attorneys from the Fish & Richardson firm,
`who are also counsel for Patent Owner,
`will be handling the contingent motion to
`amend. And those attorneys are Carl
`Renner, John Goetz, Josh Griswold and Ken
`Darby.
` ADMINISTRATIVE JUDGE JUNG: Thank
`you, Ms. Weiswasser.
` The Panel appreciates the parties
`were able to propose additional dates and
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`times for this conference. However, we
`were not able to meet last week. And the
`purpose of this conference will be, one,
`to satisfy Patent Owner's conference
`requirements before filing a motion to
`amend in, I believe it's cases
`IPR201801679, 1680 and 1682.
` And number two, to discuss Patent
`Owner's request to file a limited number
`of physical exhibits and cases,
`IPR201801670, 1676, 1678 and 1682.
` The Panel did receive a message from
`Petitioner also requested to discuss a
`pending motion for joinder. However, as
`of this Monday, the Panel has not been
`assigned to those cases, so the board is
`not ready to discuss those motions on this
`conference.
` And when the Panel is assigned the
`board will reach out to the parties for
`that conference.
` All right. So any questions about
`what we are going to discuss on this
`conference call, Mr. Torczon?
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` MR. TORCZON: No, your Honor.
` ADMINISTRATIVE JUDGE JUNG: All
`right.. Ms. Weiswasser?
` MS. WEISWASSER: No questions, your
`Honor. Thank you.
` ADMINISTRATIVE JUDGE JUNG: We will
`turn to the motion to amend first.
` All these cases are instituted either
`on April 2nd or April 3rd, the new pilot
`program for motions to amend applied to
`these cases. As you may already know, the
`pilot program affects cases instituted on
`or after March 15 --
` THE REPORTER: Judge, you're breaking
`up.
` ADMINISTRATIVE JUDGE JUNG: -- which
`is the date that notice of the pilot
`program was published in the federal
`register.
` All right. Mr. Renner, since you
`will be writing or drafting the motion to
`amend, do you have experience in drafting
`and arguing in support of a motion to
`amend in a previous IPR?
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` MR. RENNER: Your Honor, I have not
`submitted. We instead defended against
`motions to amend, but through that process
`I have some experience and, yet, the new
`rules, as we all know, are new rules. So
`I appreciate the question.
` ADMINISTRATIVE JUDGE JUNG: Okay.
`I'll just briefly discuss motions to amend
`and then I will turn to the pilot program.
` So what goes into a motion to amend
`has not been changed by the pilot program,
`but the Patent Owner will propose a
`reasonable number of substitute claims,
`and proposed substitute claims may not
`enlarge the scope of the claims or
`introduce new matter.
` The Patent Owner must indicate where
`in the original disclosure or at earlier
`filed disclosure support can be found for
`a claim added or amended. And the
`proposed amendments must respond to
`grounds of patentability.
` There is a new precedential decision
`regarding motions to amend that can be
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`found on our website. The caption of that
`case is Lectrosonics versus Zaxcom.
` S-O-N-I-C-S versus Z-A-X-C-O-M. That
`is paper 15, 15, in IPR201801129.
` And I think everyone already knows
`the governing statute is Section 316 and
`Rule 121 applies to motions to amend. And
`further guidance can be found in our trial
`practice guide and the trial practice
`guide updates.
` With that said, Mr. Renner, did you
`have any questions about specific to the
`contents in a motion to amend at this
`point?
` MR. RENNER: Thank you, your Honor.
`Just two points of clarification, maybe.
`They do relate to the motion to amend
`themselves and pieces that would be, I
`think, governed by the aspects that
`preceded the new pilot program.
` Additionally, I did want to offer our
`intention to, under the pilot program,
`solicit preliminary guidance along with
`our motion to amend submission. I
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`understand that needs to go in with the
`submission, but would welcome any further
`guidance on that as well.
` ADMINISTRATIVE JUDGE JUNG: Okay.
`Your question's specific to the contents.
`Then I will turn to the pilot program and
`your request for preliminary guidance.
` MR. RENNER: Sounds great.
` On the two questions relating to the
`amendments. The first relates to
`identification of written description
`support. Again, something that we are
`familiar with and need to identify written
`description support, we're mindful of the
`page limit of 25 pages in the motion to
`amend. And in this case, you may have
`noticed there's a quite an extensive
`priority chain.
` So our question or intention, just to
`offer, and then to ask for any guidance
`that would be helpful, is instead of
`citing to specifically the lines in
`particular reproduced text for every one
`of the cases in the chain, we thought
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`efficiency be served by citing to the
`original oldest priority and then simply
`making the affirmative representation of
`that same material that is present in each
`of the claims in the chain.
` Again, we are trying to be efficient
`here with everybody's time and energy, and
`of course, observe the 25-page limit. If
`it were necessary to make a more
`extensive, if you will, citation to
`specific instances of the same language in
`each of the different priority cases,
`then, of course, that might affect our
`ability to get under the page limit.
` We just wanted to offer that and then
`ask for any guidance you may have as it
`relates to this.
` ADMINISTRATIVE JUDGE JUNG: Okay. I
`believe a lot of these challenged patents
`are continuation with one another. So if
`you want to maintain that claims priority
`to that earliest file disclosure, you will
`have to identify in the earliest
`disclosure where support is for your
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`amended claims.
` If you run into a problem with the
`page -- number of pages identified on the
`relevant places, I would like you to
`confer with the counsel on the other side
`and try to come to an agreement on how
`many additional pages would be required to
`cover all the additional requirements and
`then contact the board.
` If the parties are able to make an
`agreement as to how many additional pages
`they will be need, then the Panel will
`probably approve that request in an order.
` Any other questions about the motion
`to amend in particular?
` MR. RENNER: Sure. Just one follow
`up on that and then a different question
`on the amendment itself.
` Our concern there isn't the
`identification of the subject matter in
`the original priority case. We think that
`is a doable proposition to the page count.
`It is all the intervening cases. It
`really is the question of is it sufficient
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`to, given that these are continuations,
`not continuations in part, make the
`representation that the same subject
`matter appears throughout the priority
`chain, rather than going through the
`laborious task of line by line identifying
`the same subject matter that does indeed
`appear.
` We just want to make sure we are
`within -- we don't want to want run afoul
`of any expectation by the Board that we
`would make that more laborious showing on
`the intervening cases, and instead we
`would be consistent with rules in
`identifying the material in the earliest
`priority cases.
` ADMINISTRATIVE JUDGE JUNG: I believe
`I would be satisfied if you were able to
`identify the supporting written
`description in the file document and then
`in the application at issue. For example,
`in this first case, identify and then make
`the representation that that same subject
`matter appears in all the intervening
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`applications. That would be sufficient
`for me.
` And that will put the other side on
`notice that you believe that the same
`written description support appears in
`every intervening application. Then they
`may -- that is enough, I believe, for the
`Petitioner to challenge you on that
`assertion.
` MR. RENNER: Thanks for the
`clarification. Yeah. That will be
`helpful for efficiency sake in mentioning.
`Thank you.
` ADMINISTRATIVE JUDGE JUNG: With the
`answer to that last question, Mr. Torczon,
`do you have a question about that?
` MR. TORCZON: I only would observe
`that there is a benefit challenge at least
`in the 80 case and the 82 case, which
`would be effected by this proposal. So,
`certainly, as long as there is no
`prejudice, because that is on the table
`already. So that is something we think
`that they probably should address. But
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`since it basically says -- the argument is
`basically that there is no support, I'm
`not sure that it really makes a difference
`because the intervening cases wouldn't
`have the support either.
` But I just throw that out there, that
`the problem has been identified as an
`issue in at least those two IPRs.
` ADMINISTRATIVE JUDGE JUNG: Thank
`you, Mr. Torczon.
` And now back to Mr. Renner. I cut
`you off before you had a chance to ask
`your other question.
` MR. RENNER: Thank you.
` The other question runs to the
`amendments themselves. In these cases,
`there's obviously a requirement for a
`motion to amend to propose a reasonable
`number of substitute claims. And with
`respect to the '844 patent, the 1680 and
`1682 proceedings they both challenges 10
`claims each. We intend to offer
`conditional amendments to eight of the 10
`claims in them.
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` And our question relates to just one
`of those claims. And that is that we wish
`to offer two conditional amendments that
`are nearly identical to the single claim.
`And they're not believed to impose a new
`burden on the Board or Petitioner, but
`it's a little unusual and it doesn't
`comport perfectly with the presumption of
`one-to-one. So we wanted -- again, I'm --
`I have not seen that before. And I didn't
`want to, you know, assume things or run
`afoul of any guidance or any expectation
`the Board may have on how we could bring
`that into the proceeding or in the motions
`to amend.
` So we really are welcoming any
`feedback guidance on that as well. I can
`go into greater detail, if it is helpful.
` ADMINISTRATIVE JUDGE JUNG: I would
`be open to allowing more than one proposed
`substitute claim for an original claim, if
`you explain why those two substitute
`claims -- I'm open to having two proposed
`substitute claims for one originally filed
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`claim. But Mr. Renner, you must explain
`in your motion to amend why you need two
`proposed substitute claims.
` MR. RENNER: Certainly. That is our
`expectation as well. Thank you.
` ADMINISTRATIVE JUDGE JUNG: All
`right.
` MR. TORCZON: Your Honor, this is
`Richard Torczon. We are in kind of an
`awkward position here. We asked Sanofi to
`identify which claims they are proposing
`to amend, and they hadn't. I think at
`least on this two-for-one proposal it
`would be good to have them specifically
`identify which claim they are talking
`about and then this authorization, this
`limited authorization is specific to that
`claim because it -- I think the transcript
`will make it clear that that is what is
`being proposed and authorized.
` ADMINISTRATIVE JUDGE JUNG: I just
`want to make clear that Mr. Renner's
`motion to amend must make it very clear
`which proposed substitute claim is a
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`substitute for one of the original claims
`and under what conditions. So that you,
`Mr. Torczon, will be able to respond to
`his argument as to why one proposed
`substitute claim is patentable over the
`asserted challenges. And why the other
`patent proposed substitute claim that is
`patentable or unpatentable over the
`asserted references.
` MR. TORCZON: Yes, Your Honor. I
`understand that part. I guess my concern
`is, what I'm looking for is guidance on
`whether this is a blanket authorization of
`two claims, potentially two claims for
`every substitute claim or just on the
`specific one that they've identified in
`this call. And preferably, if they would
`actually identify which claim that is, so
`that it's absolutely clear what everyone
`is talking about.
` ADMINISTRATIVE JUDGE JUNG: It sounds
`like Mr. Renner is not clear himself. So
`I would have Mr. Renner and Mr. Torczon to
`confer after this phone call to discuss
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`which claims, you want to propose more
`than one substitute claim for, so it is
`fair to both sides, then come to an
`agreement and let us know. Then we can
`memorialize that in a solid order. Make
`it clear, Mr. Renner.
` MR. RENNER: Thank you. It could be.
`I guess I'm a little confused as to why
`this is -- this additional detail would be
`necessary.
` I heard your Honors to pretty clearly
`articulate that to the extent that we want
`to offer a second substitute claim for any
`original claim, it would have to be very
`clear in articulating what the condition
`is, as well as the change made.
` So soon enough, we will file a motion
`to amend, and we will demonstrate the
`amendments. I guess I don't see a lack of
`clarity that would be needing to be
`resolved here through the request being
`made. I think your direction -- I take it
`as pretty clear what your direction is and
`would ask we leave it as that.
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` ADMINISTRATIVE JUDGE JUNG: Mr.
`Renner, just to be clear. Do you know if
`you're going to propose more than one
`substitute claim for more than one
`original claim or how many claims?
` MR. RENNER: Thanks for asking. No,
`we have no intention to. Our intention
`right now is to ask for one -- in one
`instance doing a single or -- in one
`instance that is as to one of the original
`claims asking for two different
`substitutes that are, like I mentioned,
`very similar.
` ADMINISTRATIVE JUDGE JUNG: Okay.
`Mr. Torczon, as a reminder, I know the
`motion to amend is due next week on the
`25th for all of these cases. So if you
`need more time, stipulate to an extension
`of the first two days, that you have more
`time to file your motion to amend.
` MR. RENNER: Thank you.
` ADMINISTRATIVE JUDGE JUNG: With all
`that said, to the pilot program. Most of
`this discussion will come out of the
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`federal register.
` So under the pilot program there are
`two new options. The Patent Owner can
`request preliminary guidance from the
`Board. Second one is Patent Owner can
`file a revised motion to amend after
`receiving petitioner's opposition and/or
`receiving the preliminary guidance.
` So turning first to the preliminary
`guidance. As Mr. Renner noted, Patent
`Owner must indicate its request for
`preliminary guidance in the motion to
`amend. I will be on the lookout to make
`sure you have or have not made that
`request because the Panel is sort of on
`the clock as well.
` I would ask you, Mr. Renner, just to
`make it clear that you are requesting or
`not requesting preliminary guidance in
`your motion to amend.
` The preliminary guidance will be
`issued four weeks after the due date for
`the opposition to the motion to amend.
`Let me see, September 17.
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` The preliminary guidance will focus
`on limitations added in the motion to
`amend that will not address patentability
`of the original claims. It will provide
`an initial discussion about whether there
`is a reasonable likelihood of a motion to
`amend each statutory and regulatory
`requirements.
` It will also provide an initial
`discussion about whether Petitioner or the
`record establishes a reasonable likelihood
`that the substitute claims are
`unpatentable. And it will not be binding
`on the Board when drafting a final written
`decision.
` It will also not be considered a
`decision under our rule 71 (d) that is
`rule governing rehearing request. So
`there will be no rehearing request that
`can be filed for a preliminary guidance.
`And obviously it's not a final agency
`action, so it's is not judicially
`reviewable.
` If Patent Owner files a reply in
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`support of its original motion to amend,
`then the case will just proceed like any
`other IPR, according to the scheduling
`order. No changes will be made to the
`scheduling order. However, if Petitioner
`-- sorry, Petitioner may file a reply to
`the preliminary guidance and Patent Owner
`may then file a sur-reply, but neither of
`those can be accompanied with new
`evidence.
` Do you have any questions about the
`preliminary guidance before I turn to the
`filing of a revised motion to amend?
` MR. RENNER: No questions, sir.
`Thank you, your Honor. No questions here.
` ADMINISTRATIVE JUDGE JUNG: Mr.
`Torczon?
` MR. TORCZON: None from Mylan, your
`Honor.
` ADMINISTRATIVE JUDGE JUNG: Turning
`to the revised motion to amend.
` Instead of filing a reply, in support
`of its original motion to amend, Patent
`Owner may file a revised motion to amend
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`by due date three, which is now
`October 29, 2019. And that revised motion
`to amend has to include one or more of the
`proposed substitute claims in place of
`previously presented substitute claims.
` You can make it contingent on the
`unpatentability of original claims, but
`not one of the proposed substitute claims
`to your original motion amend.
` You can include previous proposed
`substitute claims, arguments of evidence
`from the original motion to amend, but as
`a warning, you cannot incorporate any
`material by reference.
` So if you can have a good argument on
`page 3 of the original motion to amend,
`you cannot just say, see page 3 of the
`original motion to amend, revised motion
`to amend. You have to re-present that
`argument and evidence.
` The new argument into evidence that
`you filed with your revised motion to
`amend must be responsive to Petitioner's
`opposition and/or preliminary guidance.
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` You can't put in amendments,
`arguments and evidence that is unrelated
`to any of the issues in the preliminary
`guidance or the Petitioner's opposition.
`Petitioner may file an opposition to the
`revised motion to amend, then Patent Owner
`will have a chance to file a reply and
`thereafter Petitioner may file a
`sur-reply. All this will require a new
`reply scheduling order.
` So once we see that a revised motion
`to amend has been filed by Patent Owner,
`the Panel will work on issuing a revised
`scheduling order to accommodate all these
`new briefs.
` Then finally, the final written
`decision will address only the claims from
`the revised motion to amend. Whatever you
`proposed in the original motion to amend
`will not be addressed in the final written
`decision.
` Since the reply, sur-reply will be
`scheduled close to the oral hearing date,
`and if there is some evidence that finds
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`that to be improper, then seek
`authorization to file a motion to exclude
`reply or sur-reply evidence after the oral
`hearing or make an oral motion exclude at
`the oral hearing.
` All that said, any questions about a
`reply motion to amend? Mr. Renner?
` MR. RENNER: No questions, your
`Honor. Thank you.
` ADMINISTRATIVE JUDGE JUNG: Mr.
`Torczon?
` MR. TORCZON: None from Mylan, your
`Honor.
` ADMINISTRATIVE JUDGE JUNG: Thank
`you.
` All right. Now we will turn to the
`second request of topics. That was
`physical exhibits.
` Patent Owner requested to file
`certain -- a limited number of physical
`exhibits in cases 1670, 76, 78. So
`starting with the Patent Owner, can you
`please describe briefly what the physical
`exhibits that you wish to file are.
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`Either Mr. Renner or Ms. Weiswasser.
` MS. WEISWASSER: Good afternoon,
`your Honor.
` And for the record and the court
`reporter, this is Elizabeth Weiswasser.
` So you are correct as to the four
`noted IPRs in which we are making our
`request for authorization to submit
`certain physical models accompanying our
`Patent Owner responses that are due on the
`25th.
` We are referring to certain physical
`items that cannot be electronically filed.
`For example, like a document or another
`file that could be electronically filed on
`these physical exhibits would need to be
`manually submitted.
` In terms of what specifically we are
`proposing to file, it will be a small
`number of physical models that relate to
`certain devices. As your Honors are
`aware, this case, the patents at issue
`here claim certain injection devices. The
`asserted prior art relates also to various
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`injection devices. And because the design
`and functionality of the claimed devices
`and the prior art devices is so important
`to understanding our view as to the
`non-obviousness and, you know, and novelty
`of the devices that are claimed, we are
`proposing to make available to the Board
`physical models that we believe will be
`very helpful to the Board in understanding
`the differences between what it is that
`the patents claim and what is alleged to
`be part of the prior art. So that is the
`nature of our request, your Honor.
` ADMINISTRATIVE JUDGE JUNG: Okay. So
`it's fair to say you have models of the
`devices claimed by the various patents
`that are being challenged in these
`proceedings?
` MS. WEISWASSER: Well, they are
`devices that are described as part of the
`prior art and relate to the patentability
`arguments or the claimed devices.
` I would say also, potentially that
`relate to, you know, the devices that are
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`claimed. So it is really just a
`relatively small number of devices that
`will embody the prior art or what is --
`and/or what is claimed, if that makes
`sense.
` ADMINISTRATIVE JUDGE JUNG: Okay.
`Let me just describe the Board's concern
`with physical exhibits.
` Number one, we cannot store physical
`exhibits. Number two, the public will not
`be able to access them when they are
`accessing the files of these various
`cases. So I have a series of questions
`based on those concerns.
` Is it possible to substitute
`photographs or videos in place of other
`physical exhibits themselves?
` MS. WEISWASSER: Well, we probably
`will be making some videos available that
`will explain them. We certainly could
`provide photographs. But here, your
`Honor, the functionality of the various
`devices will be important. For example,
`to demonstrate injection force and other
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`aspects of functionality that we believe
`will be important in distinguishing the
`claimed devices from the prior art. We
`believe the Panel will be benefited from
`having an opportunity to examine and
`operate those devices.
` And I should mention, your Honor,
`that, of course, we would provide a set of
`these physical models to opposing counsel,
`right, so that they can certainly have an
`opportunity to inspect and work with them
`as well, of course. Opposing counsel will
`certainly have an opportunity to depose
`our expert on these. And the Board would,
`of course, have full discretion in making
`a decision as to, you know, whether to
`provide any weight to these exhibits or if
`so, how much weight.
` ADMINISTRATIVE JUDGE JUNG: Okay.
`Are these devices also covered by --
`actually, let me back up.
` So in all of those cases certain
`references are either US patents or US
`patent applications. So are these devices
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`covered by those asserted patent
`applications?
` MS. WEISWASSER: Well, when you say
`covered by, I would understand that, your
`Honor, to be an argument claimed by, I
`think when it comes to the -- when it
`comes --
` ADMINISTRATIVE JUDGE JUNG: Are they
`described by.
` MS. WEISWASSER: Yeah. Right. When
`it comes to the asserted prior art, for
`example, one piece of prior art that
`Petitioner had asserted is the
`Steenfeldt-Jensen patent. That patent
`describes a number of different
`embodiments and Petitioners are making a
`number of arguments as to the impact of
`those claimed embodiments, patentability
`of the challenged claims.
` So, for example, we will -- you know,
`we would propose to submit the physical
`models of certain embodiments that will
`allow the Board to have that
`three-dimensional physical functioning
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`device that will help the Board understand
`our argument, our expert's position as to
`why, you know, for example, that one or
`more of those embodiments are not
`operative. And that is understood when
`you can have that tactile experience with
`functioning three-dimensional model