throbber
Paper _____
`
` Date filed: February 24, 2017
`
`
`
`Filed on behalf of: Acrux DDS Pty Ltd. and Acrux Limited
`
`
`By: E. Anthony Figg, Lead Counsel
` Aydin H. Harston, Backup Counsel
` ROTHWELL, FIGG, ERNST & MANBECK, P.C.
` 607 14th St., N.W., Suite 800
`
` Washington, DC 20005
` Phone: 202-783-6040
` Fax: 202-783-6031
` Emails: efigg@rfem.com
`
`
`aharston@rfem.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD. AND ACRUX LIMITED,
`Petitioner,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`_______________
`
`
`PETITIONERS SUBMISSION OF TRANSCRIPT OF
`FEBRUARY 21, 2017 CONFERENCE CALL
`
`
`
`
`

`

`
`

`

`Case IPR2017-00190
`Patent 7,214,506 B2 
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
`Submitted Electronically via the PTAB E2E System
`
`Your Honors:
`
`As discussed during Tuesday’s telephone conference, Petitioners Acrux
`
`DDS Pty LTD. & Acrux Limited hereby submit the attached transcript of the
`
`February 21, 2017 telephone conference.
`
`
`
`
`
`
`
`Date: February 24, 2017
`
`
`
`
`
`
`
`
`
`

`
`Respectfully submitted,
`
`By:
`
`
`
`
`
`/ E. Anthony Figg /
`E. Anthony Figg, Reg. No. 27,195
`Aydin H. Harston, Reg. No. 65,249
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040; Fax: 202-783-6031
`
`Counsel for Petitioners
`
`
`
`2
`
`

`

`CERTIFICATE OF SERVICE
`
`Case IPR2017-00190
`Patent 7,214,506 B2 
`
`I, hereby certify that a true copy of the foregoing PETITIONERS
`
`SUBMISSION OF TRANSCRIPT OF FEBRUARY 21, 2017 CONFERENCE
`
`CALL, was served via electronic mail this 24th day of February, 2017, on the
`
`following counsel of record for Patent Owner Kaken Pharmaceutical Co., Ltd.:
`
`John D. Livingstone, Esq.
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`271 17th Street, NW, Suite 1400
`Atlanta, GA 30363-6209
`Phone: 404-653-6400
`Fax: 404-653-6444
`Emails: john.livingstone@finnegan.com
`KakenIPR@finnegan.com
`
`Naoki Yoshida
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`901 New York Ave., NW
`Washington, DC 20001-4413
`Phone: 202-408-4000
`Fax: 202-408-4400
`Email: naoki.yoshida@finnegan.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`By:
`
`
`
`
`/ Erik van Leeuwen /
`Erik van Leeuwen
`Litigation Operations Coordinator
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`
`
`
`
`
`
`
`3
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`

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`

`

`Page 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE PATENT TRIAL AND APPEAL BOARD
`
` ACRUX DDS PTY LTD. & ACRUX LIMITED,
` Petitioners,
` v.
` KAKEN PHARMACEUTICAL CO., LTD.,
` Patent Owner.
`
` Case IPR2017-00190
` U.S. Patent 7,214,506
`__________________________________________
`
` Teleconference
` New York, New York
` February 21, 2017
` 2:02 p.m.
`
` Transcript of Proceedings
` * * *
`
`212-267-6868
`
`Veritext Legal Solutions
`www.veritext.com
`
`516-608-2400
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`Page 2
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`A P P E A R A N C E S:
`Presiding:
` The Honorable SUSAN MITCHELL,
` Administrative Patent Judge
`
`Attorneys for Petitioner:
` E. ANTHONY FIGG, ESQ.
` AYDIN H. HARSTON, ESQ.
` ERIN FOLEY, ESQ.
` CAITLIN WILMOT, ESQ.
` Rothwell, Figg, Ernst & Manbeck, P.C.
` 607 14th Street, N.W., Suite 800
` Washington, DC 20005
`
`Attorneys for Patent Owner:
` JOHN D. LIVINGSTONE, ESQ.
` Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
` 271 17th Street, NW, Suite 1400
` Atlanta, Georgia 30363-6209
`
`ALSO PRESENT:
` JUDGE SCOTT BOALICK
` JUDGE BEVERLY FRANKLIN
` * * *
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`Page 3
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` -Proceedings-
` HON. MITCHELL: I am Judge
` Mitchell, and I am accompanied on the
` phone by Judges Boalick and Franklin.
` And we are here for a conference call
` in IPR2017-00190. And let me first
` ask, and I think I heard this, is
` there a court reporter on the line?
` THE COURT REPORTER: Yes, good
` afternoon. Lisa Sansone from
` Veritext.
` HON. MITCHELL: Great. And can
` I ask who is going to be responsible
` for filing the transcript with the
` Board?
` MR. FIGG: Your Honor, this is
` Tony Figg for Petitioner. We will
` take care of that.
` HON. MITCHELL: Great. Thank
` you. All right. I know that
` Petitioner asked for this call and
` gave us a list of three issues, and I
` think a fourth issue in the
` correspondence that I saw, but before
` we get started, let me get a roll call
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`Page 4
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` -Proceedings-
` and know who is on the line and let me
` begin with petitioner.
` MR. FIGG: Yes, Your Honor, this
` is Tony Figg. I think on the record
` I'm listed as E. Anthony Figg for
` Petitioner. I will be speaking for
` Petitioner today, but also on the call
` for Petitioner are Lisa Philips, Aydin
` Harston, Erin Foley and Caitlin
` Wilmot.
` HON. MITCHELL: Great. Thank
` you so much.
` And for Patent Owner?
` MR. LIVINGSTONE: Good
` afternoon. This is John Livingstone
` for Patent Owner from Finnegan.
` HON. MITCHELL: Great. And do
` you have anybody else on the line with
` you for Patent Owner?
` MR. LIVINSTONE: No, ma'am. I
` am out numbered.
` HON. MITCHELL: Okay, great.
` Let me just say I think Petitioner
` provided a list, and I'm just going to
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` quickly go over what I think the call
` is about. And it looks like
` Petitioner is asking for permission to
` file a reply brief in response to the
` Patent Owner's response on several
` issues. One, Patent Owner's
` antedating discussions and then Patent
` Owner's discussion about claim
` construction and Patent Owner's naming
` of real parties in interest and then a
` possible stay to be sought by
` Petitioner of Patent Owner's reissue
` application.
` Do I have any other issues or do
` I have those correct or are there any
` other issues that we need to discuss
` today?
` MR. FIGG: Those are the issues.
` This is Tony Figg, Your Honor. Those
` are the issues, but we did receive a
` communication from Patent Owner this
` morning that they will be amending
` their mandatory notices to identify
` Valeant as the real party in interest.
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`Page 6
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` -Proceedings-
` So I think that issue drops out in
` view of that representation by Patent
` Owners.
` MR. LIVINGSTONE: And just to be
` clear, this is John Livingstone, we
` are identifying Valeant as a real
` party in interest not the real party
` in interest. Kaken is the rightful
` owner of the patent at issue.
` HON. MITCHELL: Okay. Thank you
` for that. So then, Petitioner, you
` don't have any issue with respect to
` Patent Owner's naming of real parties
` in interest at this point?
` MR. FIGG: That is right. That
` was our concern was that the Valeant
` entity or entities be -- and Mr.
` Livingstone is more familiar with
` those entities than I am, but we
` understand they are the owner of the
` NBA and the licensee of this patent,
` so we thought they should be named as
` real parties in interest.
` HON. MITCHELL: Okay. All
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`Page 7
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` -Proceedings-
` right. Well, with that said, I guess
` number three is not an issue anymore.
` So let me hear from Petitioner first
` since you asked for the call and not
` getting into the merits of the
` remaining issues that you have which
` is why you think it's appropriate to
` file a reply addressing these issues
` at this time.
` MR. FIGG: Okay. Well, I will
` start with the first issue -- if that
` is the appropriate.
` HON. MITCHELL: Sure.
` MR. FIGG: -- which is on the
` antedating issue. We think that this
` is an issue for which a reply would be
` appropriate under Rule 42.108c. The
` Patent Owner has alleged in its
` response and its preliminary response
` that one of the references on which
` the Petitioner relies was published
` after their date of invention and,
` therefore, it's not prior art. They
` have made -- or at least they have
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`Page 8
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` -Proceedings-
` framed this as a threshold issue
` because they are asking that the
` review not be instituted on this
` basis.
` Now we of course, the document
` on its face is prior art. I don't
` think anyone disputes that. And we of
` course are seeing all of this for the
` first time because we had no way of
` knowing what evidence they had in
` their files. And I'm mindful of your
` request that we not get into the
` merits, Your Honor, it's just I would
` say we think that the evidence of
` prior invention is insufficient
` because it is being submitted for
` purposes of showing a prior reduction
` to practice and it is based entirely
` on a declaration by the inventor and a
` single document authored by the
` inventor with no independent
` corroboration.
` And so we think the law is
` pretty clear that a reduction to
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`Page 9
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` -Proceedings-
` practice has to be corroborated by
` someone other than the inventor. And
` so obviously the Board may decide that
` this would be an issue you would
` decide after institution and would
` perhaps entertain a motion to exclude
` after institution. And if that is the
` way the Board prefers to handle it,
` then of course that is fine with us as
` well. But if it is an issue that
` would be considered as part of the
` decision on whether or not to
` institute then we feel that we should
` be entitled to respond and point out
` the deficiencies in the Patent Owner's
` evidence. So I can go onto the other
` issues or if you would like to deal
` with them one at a time, however you
` would like to provide.
` HON. MITCHELL: Let's deal with
` them one at a time. And thank you for
` that explanation. Let me hear from
` Mr. Livingstone about that issue.
` MR. LIVINGSTONE: Yes. So
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`Page 10
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` -Proceedings-
` there's a couple of things that I have
` to take issue with. I think Mr. Figg
` said that our reduction of practice
` evidence was based entirely on
` inventor testimony document. Actually
` the document speaks for itself. It is
` a contemporaneous document from almost
` 15 or 16 years ago now. It was not
` created for the purposes of this
` proceeding or for any other
` litigation. And it demonstrates on
` its face that there was a reduction of
` practice of invention.
` The federal circuit has said
` numerous times that corroboration is
` not necessary to establish what a
` physical exhibit before the Board
` includes, only inventor testimony
` requires corroboration. Here we
` provided inventor testimony merely to
` eliminate or provide context to the
` reduction of practice document that is
` an internal document. And even if it
` was the source of corroboration, the
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`Page 11
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` -Proceedings-
` document wouldn't in itself
` corroborate the testimony.
` More importantly for the
` requests that you are receiving today,
` we've seen no reason for additional
` briefing on this issue because the
` Board is perfectly capable to
` determine what the document shows and
` what it doesn't. And in fact that
` debate is in a number of federal
` circuit cases as well. And any reply
` that might be offered isn't required
` and wouldn't be helpful for the Board
` to perform its role of factfinder.
` HON. MITCHELL: And thank you
` for that.
` MR. FIGG: May I respond?
` HON. MITCHELL: Sure, go ahead,
` Mr. Figg.
` MR. FIGG: Thank you. So we
` think that the Patent Owner has cited
` law in its preliminary response that
` has to do with conception evidence,
` particularly the Mahurkar case is a
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`Page 12
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` conception case. I think even as a
` conception document there would be a
` problem here because you can't simply
` rely on a document that the inventor
` created to prove even a date of
` conception without at least having
` some evidence that that document
` existed before the critical date. All
` we have is their statement that it
` existed, and I think the rules with
` respect to reduction of practice are
` even stricter.
` The inventor has to provide
` independent corroborating evidence
` beyond his own statements and his own
` documents. And normally that is in
` the form of evidence of someone who
` witnessed the reduction of practice or
` someone who did testing, or I'm sure
` the Board is very familiar with
` evidence that is sufficient to show
` corroboration of reduction of
` practice, but simply saying I reduced
` it to practice in a declaration and
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`Page 13
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` then provide a document that the
` inventor says existed before the
` critical date, but there's no evidence
` to support that is not sufficient.
` And, you know, we can refer to
` cases like Hahn versus Wong and Reese
` versus Hurst and numerous other cases
` Singh versus Brake that had
` consistently held this. And this is
` what we -- you know if the Board wants
` to deal with this issue at this time,
` this is the kind of information we
` would like to address in a reply.
` HON. MITCHELL: Let me ask you
` this, Mr. Figg, do you believe that as
` the Petitioner you would need
` deposition testimony to fully vet
` these issues?
` MR. FIGG: I am sorry, Your
` Honor.
` HON. MITCHELL: No, go ahead.
` MR. FIGG: At this stage, no, I
` don't think we would because the issue
` is simply whether the evidence that
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`Page 14
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` -Proceedings-
` the Patent Owner has presented to
` establish an earlier date of invention
` is sufficient, and we think as a
` matter of law it is not sufficient.
` So at this stage, we would not be
` asking for additional discovery on
` that issue.
` HON. MITCHELL: Okay.
` MR. LIVINGSTONE: And I might
` add if it's truly a matter of law as
` Mr. Figg suggests, then there's no
` need for additional briefing. The
` Board is certainly able to function as
` a factfinder and then apply relevant
` law. We personally think that the law
` is different. That doesn't require
` additional briefing to determine
` whether this declaration -- not the
` declaration, I apologize, whether this
` internal report satisfies reduction of
` practice for purposes of antedating a
` piece of prior art.
` MR. FIGG: Well, Your Honor, the
` Patent Owner has put in its view of
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`Page 15
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` -Proceedings-
` what the law is in its preliminary
` response. Obviously we have a
` disagreement about what the law is and
` how that law should apply to the facts
` that they have purported to establish
` through their declaration and their
` documentary exhibits. So, again, if
` the Board wants to deal with this
` issue at this time, we think the Board
` could benefit from a reply from the
` Petitioner on this point.
` HON. MITCHELL: Okay. Thank you
` both for that. I think we understand
` your respective positions on the first
` issue. Let's move on to the second
` issue where Petitioner would like to
` address Patent Owner's argument that
` Petitioner failed to provide claim
` constructions that they should have
` provided. So let me hear from
` Petitioner, Mr. Figg.
` MR. FIGG: Yes, thank you, Your
` Honor. So, again, the only reason we
` raised this issue at this time is that
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`Page 16
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` the Patent Owner owner again has
` stated in its preliminary response
` that it regards this issue as a
` threshold issue that would justify
` denial of institution. And we think
` the Patent Owner has misstated and
` overstated the law and the applicable
` rules here. The Complaint seems to
` think that there is not a section in
` the petition with the section heading
` called claim construction but both
` parties have identified three claim
` terms that are at issue.
` As Your Honor may know by this
` point, the patent involved in this
` request is a patent directed to the
` treatment of fungal infections of the
` nails, a condition called
` onychomycosis. And two claimed terms
` that we think do have to be understood
` to understand the applicability of the
` prior art that we've cited are the
` term nail and the term onychomycosis,
` but as we pointed out in our petition,
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`Page 17
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` -Proceedings-
` both of these terms are expressly
` defined in the patent at issue. And
` we discussed those expressed
` definitions in our petition and then
` used those definitions in our
` arguments for unpatentability.
` The third term that the Patent
` Owner has identified is
` therapeutically effective amount which
` also is defined in the specification.
` Our view on that was that that is a
` very common term used in method of
` treatment claims and it simply should
` be given its ordinary and customary
` meaning. So we saw no reason to
` discuss that one specifically in our
` petition. We simply applied it
` according to what we think its
` ordinary meaning is. If Patent Owner
` thought it had a different meaning,
` they could have said so.
` We think the Board here has made
` it clear in a number of other
` decisions that claim construction is
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` not even required for institution
` because of the heavy presumption that
` a claimed term carries its ordinary
` and customary meaning. And I would
` refer to the Cox versus AT&T decision
` which is IPR2015-01187, and there's
` another case with the same name Cox
` versus AT&T, IPR2015-01227 which the
` Board has explained that as long as
` the challenged claim does contain a
` means plus function limitation it
` could be assessed in the prior --
` against the prior art whether there is
` a specific discussion of claimed
` construction in the Petitioner or not.
` So the Board has already
` concluded in other cases that having a
` separate section titled claim
` construction is not necessary for
` institution and indeed even claim
` construction itself is not necessary
` for institution. Again, since Patent
` Owner has identified this as a
` threshold issue, we asked for an
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` opportunity to provide a brief
` response but again, only the Board may
` decide it doesn't need that and that
` of course is fine with us as well, but
` we just want to have an opportunity to
` address it.
` HON. MITCHELL: Okay. Thank you
` very much for that statement, Mr.
` Figg. And let me go to Mr.
` Livingstone for a response.
` MR. LIVINSTONE: Thank you, Your
` Honor. In the e-mail that we received
` keying this issue up, there's a clause
` that says from Petitioner "despite
` these terms being discussed in the
` petition and expressly defined in the
` specification." At base if that
` statement is true then we see no
` reason for additional briefing. I
` think the reason Petitioner has
` requested this additional briefing is
` because they recognize a deficiency in
` their petition and they would like to
` try and correct it. We believe that
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` that is not appropriate in a reply
` brief. They started this proceeding.
` They should have taken care of this in
` the beginning.
` And kind of at base what you see
` is Petitioner just noted, for
` instance, the term nail has an
` expressed definition, but when they
` construe nail in their paper they
` construe it to broadly include things
` like skin structures. This is their
` petition page 27, footnote 6. The
` term skin structures does not exist in
` patent and it does not exist in the
` file history. And there's nothing in
` the petition to explain how one of
` ordinary skill in the art would
` include or why they would include skin
` structures in the definition of nails
` and how they would interpret skin
` structures in the context of
` onychomycosis and how that would apply
` to the prior art teachings.
` And so I think we are sitting
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` -Proceedings-
` here in a position where they have
` done some piecemeal claim
` construction, but it is at odds with
` what the specification describes. And
` without understanding exactly what
` those claim construction positions
` are, we believe that we can't
` understand how the challenge claims
` are to be construed and that is
` critical to understanding the scope of
` the claims and their positions.
` Again, I think at base you have
` a position where if what they say is
` in their petition is right there's
` absolutely no reason to have
` additional briefing and if what they
` say in their petition doesn't exist,
` they shouldn't be able to file a reply
` and clean it up because that would
` necessarily and substantively
` transform the proposed challenges.
` And if the Board believes that they do
` need additional briefing from the
` Petitioner to cure any claim
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`Page 22
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` -Proceedings-
` construction issues, we would also
` request the opportunity to respond to
` any newly proposed claim construction
` and any effects it has on any existing
` argument in the petition.
` HON. MITCHELL: Okay. I think
` we understand both of your respective
` positions on issue number two. Let's
` move on to --
` MR. FIGG: Could I clarify just
` one thing, Your Honor?
` HON. MITCHELL: Okay.
` MR. FIGG: We are not asking for
` a reply for purposes of putting in
` some different or new claim
` construction. What we are asking for
` is to respond to the argument that
` Patent Owner made in its preliminary
` response that there is no claim
` construction in our petition and,
` therefore, institution should be
` denied as a matter of law. We think
` that is just wrong on two counts.
` It's wrong that there's no claim
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`Page 23
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` -Proceedings-
` construction, and I think we heard a
` concession just a couple of minutes
` ago from Patent Owner that there is in
` fact claimed construction in the
` petition. And secondly, it is wrong
` because the Board has held that that
` is not a basis for denying
` institution.
` So that is what we would want to
` address in the reply. We do not have
` any intention of introducing new claim
` constructions. We think even the part
` that Mr. Livingstone just referred to
` about skin structures comes directly
` from the expressed definition that is
` in their patent.
` HON. MITCHELL: Thank you for
` that. Let's move on to the fourth
` issue about a request for a stay of
` the reissue on the Patent Owner. Mr.
` Figg.
` MR. FIGG: Yes. Well, we have a
` situation here now where different --
` I will use the term loosely tribunals
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` within the patent office are going to
` be looking at the same issues because
` the Patent Owner has filed a reissue
` application and has explicitly asked
` that prosecution on that reissue
` application be continued or pursued in
` parallel with the IPR proceedings.
` And at a minimum, the reissue examiner
` will have to be IPR petition and will
` be considering some of the same issues
` if not all of the same issues as the
` Board.
` We have not made a final
` decision on this, but it may very well
` be that Petitioner will file a protest
` if that prosecution proceeds. So you
` have a situation where a reissue
` examiner and the patent trial and
` appeal Board are going to be
` considering the same issues at the
` same time which is not only wasteful
` but has potential of leading to
` inconsistent results. There are --
` there is authority for the Board to
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`Page 25
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` -Proceedings-
` stay the examination of a reissue
` application.
` I would refer the Board to
` Hewlett Packard versus MCM Portfolio
` which is IPR2013-00217, also Unified
` Patents versus Harry Heslop
` IPR2016-01464 and Rule 42.122 all say
` that the Board has this authority.
` And in fact I would specifically refer
` to the Board to Rule 42.3 which says
` that the Board has the authority to
` exercise exclusive jurisdiction within
` the office over an involved
` application and patent during the
` proceeding. So we think this is
` really just a matter of judicial and
` party resource economy.
` Obviously once the IPR is
` finally decided either it's the
` institution phase or the review stage,
` the reissue examiner will have the
` benefit of that and will be bound by
` the outcome of it and that then can
` guide how those proceedings go forward
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`Page 26
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` -Proceedings-
` from that point.
` HON. MITCHELL: Okay, thank you
` so much. Let me get Mr. Livingstone's
` response for Patent Owner.
` MR. LIVINSTONE: Thank you, Your
` Honor. As an initial matter, we don't
` believe that there are the same issues
` pending in the reissue and this IPR
` petition but regardless I think to say
` it's inefficient for that proceeding
` to move forward without an institution
` decision is putting the cart before
` the horse. I don't think there's any
` duplication of efforts right now
` unless and until there is an
` institution decision.
` One of the cases that Mr. Figg
` has identified, the Hewlett Packard
` case did in fact stay a reissue
` application before an institution
` decision, but it was under the very
` different fact where Patent Owner did
` not oppose the request and actually
` joined it. That case also is very
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`Page 27
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` -Proceedings-
` different because there were the exact
` same issues and rejections pending on
` appeal for all claims. This will not
` be the case in the reissue that is
` pending here. I submit that if the
` Board institutes at that time moving
` first a stay and having us fight and
` brief that issue up makes a lot more
` sense then doing so now before the
` Board has made any decision on
` institution.
` HON. MITCHELL: Okay. Thank you
` very much. I think we understand the
` issues. Give me a brief moment to
` confer with the panel and we will be
` right back.
` MR. FIGG: Okay, thank you.
` (There was a pause in the
` proceeding.)
` HON. MITCHELL: This is Judge
` Mitchell. I have conferred with my
` colleagues on the panel Judge Boalick
` and Judge Franklin, and we appreciate
` the opportunity to hear both sides of
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`Page 28
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` the issues raised, but at this time,
` we do not believe it would be
` necessary for Petitioner to file a
` reply to address what amounts to
` issues of law in relation to the first
` issues addressed in dealing with the
` allegedly uncorroborated and
` declaration document the claim
` construction issues.
` As to the fourth issue that is
` still on the table the possible stay
` of the reissue filed by the Patent
` Owner, we believe that at this point
` it's premature until we institute, if
` we institute a trial on this case.
` And certainly Petitioner can raise it
` again if we do institute and go
` forward with this all and raise that
` issue again and certainly speak at
` that point to ask for briefing for a
` stay.
` And I think as we discussed, the
` third issue was taken care of which
` Patent Owner is filing an amended real
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`Page 29
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` -Proceedings-
` party in interest statement.
` So I believe that addresses all
` of the issues. Have I addressed
`

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