`Filed: October 1, 2014
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner.
`
`____________________
`
`Case IPR2014-00998
`Patent 8,475,832
`____________________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION FOR JOINDER
`
`
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`Case IPR2014-00998
`Patent No. 8,475,832
`Patent Owner RB Pharmaceuticals Limited opposes Petitioner Biodelivery
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`Sciences International, Inc.’s motion for joinder seeking to join the present
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`proceeding with IPR2014-00325 (“the ’325 IPR”). This opposition is timely
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`pursuant to the Board’s Order on September 2, 2014. Paper 7, 3.
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`As shown in the concurrently filed Patent Owner’s Preliminary Response,
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`trial should not be instituted in the present proceeding because Petitioner’s
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`redundant second Petition asserting substantially the same arguments and art
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`against the same claims of the same patent should be denied in its entirety as to all
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`challenged claims under 35 U.S.C. §§ 314(a) and 325(d). This motion for joinder
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`will then be moot.
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`However, although the primary reference, Euro-Celtique, that Petitioner
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`relies on in each of the four Grounds asserted in this proceeding, was asserted in
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`the Petition in the ’325 IPR, the Board did not institute on any Ground based on
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`that reference in the ’325 IPR. Therefore, in the event that the Board does not find
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`that the present Euro-Celtique-based Grounds are redundant of those presented in
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`the ‘325 IPR and decides to institute trial on any of the presently asserted Grounds,
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`joinder with the ’325 IPR (and under the schedule now set in that IPR) would be
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`inappropriate for numerous reasons: (1) this proceeding, if instituted, would
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`present separate Grounds of unpatentability relying on separate art (specifically, a
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`separate primary reference) than the Grounds instituted on the ’325 IPR (again,
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`1
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`Case IPR2014-00998
`Patent No. 8,475,832
`Euro-Celtique was asserted but not instituted on in the ’325 IPR), and (2) the
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`current trial schedule in the ’325 IPR would not accommodate the additional
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`briefing and discovery required by institution of one or more Grounds in this
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`proceeding due to the 5 month delay between Petitioner’s filing of the two
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`proceedings.
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`I.
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`Statement of Material Facts1
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`1.
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`On January 15, 2014, Petitioner filed a petition for inter partes review
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`of Claims 15-19 of U.S. Patent No. 8,475,832 (“the ’832 patent”) (“first Petition”).
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`1 Petitioner submitted a statement of material facts in its motion for joinder. Paper
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`6, 1-7. Because it believes Petitioner’s statement to be incomplete of the facts
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`material to whether joinder is appropriate in this proceeding, Patent Owner submits
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`the following statement of material facts. Additionally, Patent Owner notes that
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`Petitioner spends nearly half of its statement of material facts discussing events
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`relating to U.S. Application No. 13/964,975. Paper 6, 4-7. Patent Owner submits
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`those purported “facts” are wholly irrelevant, i.e., not material, to whether joinder
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`should be granted in the instant proceeding. Indeed, the immateriality of that
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`discussion is evidenced by the fact that Petitioner doesn’t rely on a single “fact”
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`relating to that proceeding to support the merits of its motion. See generally Paper
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`6, 7-15.
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`2
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`Case IPR2014-00998
`Patent No. 8,475,832
`Biodelivery Sciences Int’l, Inc. v. RB Pharmaceuticals Ltd., IPR2014-00325 (“the
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`’325 IPR”), Paper 5. The first Petition requested trial be instituted for Claims 15-19
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`on the following Grounds:
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` Ground 1 – Anticipated by the Suboxone Tablet Label
` Ground 2 – Obvious in view of the Suboxone Tablet Label
` Ground 3 – Obvious in view of the Suboxone Tablet Label and Yang
` Ground 4 – Obvious in view of the Suboxone Tablet Label, Yang, and Birch
` Ground 5 – Anticipated by Labtec
` Ground 6 – Obvious in view of Labtec
` Ground 7 – Obvious in view of Labtec and Birch
` Ground 8 – Obvious in view of Labtec, Birch, and Yang
` Ground 9 – Anticipated by Euro-Celtique
` Ground 10 – Obvious in view of Euro-Celtique
` Ground 11 – Obvious in view of Euro-Celtique and Birch
` Ground 12 – Obvious in view of Euro-Celtique, Birch, and Yang
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`2.
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`In support of the first Petition, Petitioner presented declarations of Dr.
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`Reitman (Ex. 1004 in this proceeding and the ’325 IPR) and Dr. Lavin (Ex. 1005
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`in this proceeding and the ’325 IPR).
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`3.
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`On April 30, 2014, Patent Owner filed its Preliminary Response in the
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`’325 IPR, which challenged the sufficiency of each Ground proposed by Petitioner
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`and argued Petitioner failed to present evidence in the form of expert testimony
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`supporting its obviousness Grounds. IPR2014-00325, Paper 15.
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`4.
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`On June 20, 2014, more than five months after the first Petition and
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`almost two months after Patent Owner’s Preliminary Response in the ’325 IPR,
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`Petitioner filed another petition for inter partes review of Claims 15-19 of the ’832
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`3
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`Case IPR2014-00998
`Patent No. 8,475,832
`patent (“second Petition”). Paper 2. The second Petition requested trial be
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`instituted for Claims 15-19 on the following Grounds:
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` Ground 1 – Obvious in view of Euro-Celtique
` Ground 2 – Obvious in view of Euro-Celtique and the EMEA Study Report
` Ground 3 – Obvious in view of Euro-Celtique, the EMEA Study Report, and
`the ’883 Application
` Ground 4 – Obvious in view of Euro-Celtique, the EMEA Study Report, and
`Yang
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`5.
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`In support of the second Petition, Petitioner presented declarations of
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`Dr. Reitman (Ex. 1004 in this proceeding and the ’325 IPR), Dr. Lavin (Ex. 1005
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`in this proceeding and the ’325 IPR), and Dr. Celik (Ex. 1033). Dr. Celik did not
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`provide a declaration in the ’325 IPR. The second Petition does not cite to the
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`declarations of Dr. Reitman or Dr. Lavin in discussion of any of its proposed
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`rejections. See generally Paper 2, 34-54. Rather, Petitioner only relies on the
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`declaration of Dr. Celik in its proposed Grounds 1-4 in the second Petition.
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`6.
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`On July 29, 2014, the Board issued a Decision instituting trial in the
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`’325 IPR only with regard to Ground 5 (anticipation by Labtec) and Ground 8
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`(obviousness over Labtec, Birch, and Yang). IPR2014-00325, Paper 17. The Board
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`also issued a Scheduling Order that specified October 17, 2014 as the Due Date for
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`Patent Owner’s Response to the Petition (Due Date 1) and March 20, 2015 as the
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`Due Date for Oral Argument (Due Date 7). IPR2014-00325, Paper 18.
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`7.
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`On August 26, 2014, the Board held an initial conference call with the
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`parties during which Petitioner’s proposed motion for joinder was discussed and
`4
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`Case IPR2014-00998
`Patent No. 8,475,832
`authorized. Paper 7. The parties agreed to try to work out a mutually agreeable
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`schedule for a potential joined proceeding but thus far have not reached an
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`agreement.
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`II.
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`Legal Standard for Joinder
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`The America Invents Act created inter partes review “as an efficient,
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`streamlined, and cost-effective alternative to district court litigation.” Macronix
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`Int’l Co., Ltd. v. Spansion, LLC, IPR2014-00898, Paper 15, 3. To further this goal,
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`congress gave the Board authority to join like proceedings. Specifically, 35 U.S.C.
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`§ 315(c) provides (emphasis added):
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`JOINDER. – If the Director institutes an inter partes review, the
`Director, in his or her discretion, may join as a party to that inter
`partes review any person who properly files a petition under section
`311 that the Director, after receiving a preliminary response under
`section 313 or the expiration of the time for filing such a response,
`determines warrants the institution of an inter partes review under
`section 314.
`
`The decision to grant joinder is discretionary. See 35 U.S.C § 315(c); 37 C.F.R. §
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`42.122. “When exercising its discretion, the Board is mindful that patent trial
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`regulations, including the rules for joinder, must be construed to secure the just,
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`speedy, and inexpensive resolution of every proceeding.” Macronix Int’l Co., Ltd.
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`v. Spansion, LLC, IPR2014-00898, Paper 15, 3 (citing 35 U.S.C. § 316(b) and 37
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`C.F.R. § 42.1(b)).
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`5
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`Case IPR2014-00998
`Patent No. 8,475,832
`As the moving party, Petitioner has the burden of proof in establishing it is
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`entitled to the requested relief – joinder of this proceeding with the ’325 IPR. See
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`37 C.F.R. §§ 42.20(c); 42.122(b). In support of its motion for joinder, Petitioner
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`was required to:
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`(1) set forth the reasons why joinder is appropriate; (2) identify any
`new grounds of unpatentability asserted in the petition; (3) explain
`what impact (if any) joinder would have on the trial schedule for the
`existing review; and (4) address specifically how briefing and
`discovery may be simplified.
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`Paper 7, 2.
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`III. Petitioner Failed to Meet Its Burden to Establish It Is Entitled to
`Joinder
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`As discussed below, this proceeding raises Grounds of unpatentability that
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`necessarily raise issues additional to those raised by the Grounds instituted upon in
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`the ’325 IPR. Further, joinder of this proceeding with the’325 IPR would
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`significantly impact the current trial schedule in the IPR and unfairly complicate
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`briefing and discovery in the ’325 IPR. For at least these reasons, Patent Owner
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`submits that joinder is not appropriate in this proceeding and, therefore, the Board
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`should exercise its discretion and deny Petitioner’s motion for joinder. In other
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`words, in the event trial is instituted in the present IPR, this case cannot reasonably
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`be litigated and adjudicated within the scheduling framework of the ’325 IPR,
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`which is on a track that is over 5 months ahead of the present case.
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`6
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`Case IPR2014-00998
`Patent No. 8,475,832
`The Second Petition Presents New Grounds of Unpatentability
`that Raise New Issues for Trial
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`A.
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`In its Preliminary Response (concurrently submitted herewith as Paper 9),
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`Patent Owner submits that because Grounds 1-4 in the second Petition are
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`redundant of Grounds set forth in the first Petition and for which trial has already
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`been instituted in the ’325 IPR, the Board should deny institution of this
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`proceeding altogether. See generally Paper 9, 20-34. To the extent that the Board
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`decides otherwise, i.e., decides the Grounds proposed in this proceeding are not
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`redundant of those in the ’325 IPR, and chooses to institute trial in this proceeding,
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`then Patent Owner submits this proceeding necessarily presents new Grounds of
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`unpatentability, which necessarily raise new issues to be addressed.
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`In support of its motion, Petitioner attempts to analogize this proceeding to
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`that in Ariosa Diagnostics v. Isis Innovation Ltd., IPR2013-00250, where the
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`Board granted a petitioner’s motion for joinder. In granting the motion, the Board
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`focused on the facts that (1) “[t]he only additional prior art cited in the [second]
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`proceeding was added to address the limitations of the dependent claims”
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`challenged in the second proceeding, and (2) the second proceeding relied upon
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`declarations from only declarants in the first proceeding, i.e., the second
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`proceeding did not introduce new declarants. IPR2013-00250, Paper 25, 2-3
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`(September 3, 2013).
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`Here, in the event that the Board institutes trial with respect to any of
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`7
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`Case IPR2014-00998
`Patent No. 8,475,832
`Grounds 1-4 set forth in the second Petition, this proceeding will necessarily
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`involve entirely separate art from the art on which institution in the ’325 IPR was
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`based and a new declarant. For example, as discussed above, the ’325 IPR was
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`instituted only with respect to two Grounds – anticipation by Labtec and
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`obviousness over Labtec, Birch, and Yang. Thus, regardless of whether other
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`references were cited in the first Petition, the only references relevant in that
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`proceeding now are Labtec, Birch, and Yang. In contrast, Grounds 1-4 in this
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`proceeding are based on Euro-Celtique, the EMEA Study Report, the ’883
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`Application, and Yang. Thus, each of the present Grounds 1-4 necessarily includes
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`art not was not relied on in any Ground on which trial was instituted in the ’325
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`IPR. Specifically, Petitioner neither cited to nor listed Euro-Celtique (primary
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`reference in every ground in this proceeding) or the ’883 Application in any
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`Ground for trial that was instituted in the ’325 IPR. Indeed, only proposed Ground
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`4 of this proceeding – obviousness in view of Euro-Celtique, the EMEA Study
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`Report, and Yang – includes a single common reference with the ’325 IPR – Yang.
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`Additionally, unlike in Ariosa, each Ground proposed in this proceeding
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`substantially relies on a declaration (Ex. 1033) from Dr. Celik, who was not a
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`declarant in the ’325 IPR. Further, while Petitioner submits declarations of Dr.
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`Lavin and Dr. Reitman in both proceedings, Petitioner does not rely on those
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`declarations in support of any Ground of rejection in this proceeding.
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`8
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`Patent No. 8,475,832
`Petitioner also relies on ABB Inc. v. Roy-G-Biv Corp., IPR2013-00286,
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`Paper 14, 3-4 (Aug. 9, 2013), in support of its motion for joinder. There, the Board
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`granted such a motion because, inter alia, “joinder introduce[d] only two pieces of
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`new prior art (both of which are exhibits in [the first proceeding].” Paper 6, 8-9.
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`Again, the facts in ABB are very different from those in this proceeding. For
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`example, there, the first proceeding was instituted as to a single Ground of
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`obviousness – “Gertz, Stewart, and Morrow.” ABB Inc. v. Roy-G-Biv Corp.,
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`IPR2013-00074, Paper 17, 18 (April 18, 2013). The Ground proposed in the
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`second proceeding simply added two additional references (both of which were
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`exhibits in the first proceeding) to the Ground in the first proceeding – obviousness
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`in view of “Gertz, Stewart, Morrow, Brockschmidt, and Architect.” IPR2013-
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`00286, Paper 14, 2. Thus, the unitary joined Ground (the same Ground was merely
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`expanded upon) was still based on the only three references (including the primary
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`reference) of the first proceeding. Here, on the other hand, any Ground joined to
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`the ’325 IPR would necessarily include at least a new primary reference (Euro-
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`Celtique). Another distinction between this proceeding and ABB is that, there, the
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`patent owner “d[id] not oppose the motion for joinder,” which the Board
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`considered in its determination to grant the motion. Id. at 4. Here, to the contrary,
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`Patent Owner opposes joinder of these proceedings.
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`Petitioner also argues that joinder is appropriate because it will somehow
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`9
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`Case IPR2014-00998
`Patent No. 8,475,832
`moot arguments that Patent Owner will make in the ’325 IPR. Specifically,
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`Petitioner alleges that: (1) “[j]oinder will moot Patent Owner’s new and
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`unexpected line of argument that the prior art is not enabling” because Euro-
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`Celtique or the ’883 Application purportedly are enabling, Paper 6, 9, and (2)
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`“joinder will preclude Patent Owner from pursuing its meritless argument that [a
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`certain claimed feature] was not disclosed” because that feature purportedly is
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`disclosed in the EMEA Study Report, id. at 10.
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`Petitioner’s argument is entirely misplaced. Indeed, whether Euro-Celtique,
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`the ’883 Application, or the EMEA Study Report (none of which are used in
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`Grounds instituted on in the ’325 IPR) disclose and/or enable certain claimed
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`features does not necessarily bear or have preclusive effect on arguments Patent
`
`Owner will make regarding the teachings of Labtec, Birch, and Yang (the only
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`references relied on in Grounds instituted in the ’325 IPR). In other words, even
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`assuming, arguendo, that the EMEA Study Report discloses a certain claim
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`limitation of Claim 15, Patent Owner would not be precluded from arguing that
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`Claim 15 is not obvious over Labtec, Birch, and Yang because those references
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`fail to disclose that limitation. Rather, joinder would simply complicate these
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`proceedings further because Patent Owner would still make all of the same
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`arguments it would have made in the ’325 IPR, but Patent Owner will also make
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`new arguments addressing the new issues presented by the new Grounds, art, and
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`10
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`Case IPR2014-00998
`Patent No. 8,475,832
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`declarant in this proceeding.
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`Because this proceeding introduces new Grounds of unpatentability, new art,
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`and new declarants, Patent Owner submits that joinder of this proceeding with the
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`’325 IPR is not appropriate.
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`B.
`
`Joinder Will Significantly Impact the Current Trial Schedule in
`the ’325 IPR and Unfairly Prejudice Patent Owner
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`Contrary to Petitioner’s argument, joinder of this proceeding with the ’325
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`IPR would make it impossible to complete the ’325 IPR within one year from
`
`institution. While the Board may adjust the timing of a final determination in the
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`case of joinder, 35 U.S.C. 316(a)(11), the Board still exercises discretion in joining
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`cases “to secure the just, speedy, and inexpensive resolution of every proceeding.”
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`IPR2014-00898, Paper 15, 3; see also Macronix Asia Limited v. Spansion LLC,
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`IPR2014-00898, Paper 15, 5 (denying joinder where “[u]nder either of the parties’
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`proposed schedules, joinder would have a significant adverse impact on our ability
`
`to complete the existing proceeding in a timely manner, which weighs against
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`granting the motion for joinder”).
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`The second Petition was filed more than five months after the first Petition,
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`and thus, this proceeding is fully 5 months behind the ’325 IPR. See SDI Tech.,
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`Inc. v. Bose Corp., IPR2014-00346, Paper 15, 4-5 (denying joinder where “the trial
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`schedules in the two cases are out of synchronization by roughly six months [such
`
`that i]t would not be practical to join or consolidate the instant case with [the first
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`11
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`Case IPR2014-00998
`Patent No. 8,475,832
`proceeding] without moving the date for the oral hearing, an outcome neither the
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`parties, nor the Board, desires”). While Petitioner is correct that, in Ariosa,
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`proceedings initiated over six months apart were still able to be joined without
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`significantly impacting the trial schedule, as pointed out above, the facts in Ariosa
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`were significantly different than the facts here. For example, in Ariosa, the joined
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`Ground was based on the same primary reference as the first proceeding and was
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`supported by the same declarants as in the first proceeding. The overwhelming
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`similarities between the first and second proceeding meant that joinder added little,
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`if any, complexity to the first proceeding, such that a very compressed trial
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`schedule was possible without prejudicing either party. On the other hand, here,
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`each new Ground is based on a different primary reference (Euro-Celtique) than
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`the Grounds on which trial was instituted in the ’325 IPR (Labtec). Further, each
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`new Ground is supported by a new declarant (Dr. Celik), who provided no
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`declaration in the ’325 IPR. Due to these significant substantive differences
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`between the ’325 IPR and this proceeding, joinder of the proceedings would
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`severely prejudice Patent Owner if it required a condensed trial schedule.
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`Additionally, while Petitioner is correct that Patent Owner “already
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`indicated that it will not move to amend the challenged claims,” Paper 6, 12, Patent
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`Owner indicated it would not amend based on Grounds instituted in the ’325 IPR.
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`Patent Owner cannot make a similar promise in this proceeding at this point.
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`12
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`Case IPR2014-00998
`Patent No. 8,475,832
`Whether Patent Owner will choose to amend will be a strategic decision Patent
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`Owner will need to evaluate based on a variety of factors.
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`Joinder Will Further Complicate Briefing and Discovery
`C.
`Joinder of this proceeding with the ’325 IPR will not simplify discovery and
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`briefing. Indeed, both briefing and discovery will be more complicated from both
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`substantive and timing perspectives.
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`Briefs in the joined proceedings have to address new substantive issues. As
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`discussed above, each Ground raised in the second Petition is based on a separate
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`primary reference as compared to the Grounds instituted on in the ’325 IPR. Thus,
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`in addition to each argument for patentability Patent Owner will make regarding
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`the proposed rejections based on Labtec (primary reference in the instituted
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`Grounds of the ’325 IPR), Patent Owner would also be required to make
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`arguments addressing one or more Grounds based on Euro-Celtique (primary
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`reference in each Ground in the second Petition).
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`Briefing in the joined proceedings would also be more complicated due to
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`the timing of the trial schedule. The scheduling order currently indicated that the
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`Patent Owner’s Response in the ’325 IPR is due on October 17th, making it likely
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`that Patent Owner would have already filed its Response in the ’325 IPR prior to a
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`13
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`decision on institution or joinder in this proceeding.2 Therefore, joinder would
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`result in Patent Owner filing two separate Patent Owner responses – the second to
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`address new Grounds instituted in this proceeding. Additionally, the timing of the
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`briefing schedule could be further complicated in the event that Patent Owner
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`decides to file a motion to amend in this proceeding based on new Grounds
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`instituted.
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`Discovery is also further complicated by joining the proceedings. For
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`example, each new Ground in the second Petition is supported by a declaration of
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`Dr. Celik, thus requiring additional discovery (a deposition) not necessary in the
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`’325 IPR. Additionally, in the event that Patent Owner should depose Dr. Lavin
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`and Dr. Reitman, those depositions would occur in all likelihood prior to the
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`Board’s decision on whether to institute on any of the Grounds presented in this
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`proceeding. See Macronix Asia Limited v. Spansion LLC, IPR 2014-00898, Paper
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`15, 5 (denying joinder where the first proceeding was “already well underway,
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`with Patent Owner having cross-examined Petitioner’s Declarant and filed its
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`2 The parties have agreed to modify Due Date 1 in the ’325 IPR to November 7,
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`2014, although a stipulation has not yet been filed. Even when Due Date 1 is
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`pushed back to November 7, 2014, the Board is still unlikely to decide on
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`institution and joinder prior to that date.
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`14
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`Response”).
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`Finally, Petitioner’s contentions that joinder is appropriate so that the Board
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`doesn’t have to “consider . . . issues twice” is without merit. Paper 6, 14. The
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`Board has previously denied joinder in a similar situation even though similar
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`claims and claim constructions were present but different art was cited in the
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`second proceeding. See SAP America, Inc. v. PI-Net Int’l, Inc., CBM2014-00018,
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`Paper 16, 3. There, the Board simply “applie[d] the same claim constructions [in
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`the second proceeding] as those [it] applied in [the first proceeding].” Id. Further,
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`the Board, stated, “[w]hile our final decision in [the second] proceeding may be
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`informed by our analysis in the [first] proceeding[], our consideration of
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`additional prior art in this proceeding can proceed independently.” Id. (emphasis
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`added). Likewise, here, the Board’s final decision in this proceeding could be
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`informed by a final decision in the ’325 IPR while still independently considering
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`the new art, e.g., Euro-Celtique, presented in this proceeding.
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`IV. CONCLUSION
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`For at least these reasons, Patent Owner respectfully requests the Board
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`exercise its discretion and deny Petitioner’s motion for joinder.
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`Dated: October 1, 2014
`
`Respectfully submitted,
`
`/James M. Bollinger/
`James M. Bollinger, Reg. No. 32,555
`Daniel A. Ladow, pro hac vice pending
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Opposition to Petitioner’s Motion for Joinder was served electronically
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`via email on October 1, 2014, on attorneys for Petitioner:
`
`Danielle L. Herritt
`Kia L. Freeman
`MCCARTER & ENGLISH, LLP
`265 Franklin Street
`Boston, MA 02110
`
`dherritt@mccarter.com
`IPR832@mccarter.com
`
`Dated: October 1, 2014
`
`/James M. Bollinger/
`James M. Bollinger
`Reg. No. 32,555
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`16