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`Attorney Docket No. 117744-00048
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`Paper No. _________
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
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`Petitioner,
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`v.
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`RB PHARMACEUTICALS LTD.,
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`Patent Owner.
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`_______________
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`IPR2014-00998
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`Patent 8,475,832 B2
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`PETITIONER’S MOTION FOR JOINDER
`UNDER 37 C.F.R. § 42.122(B)
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`I.
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`Table of Contents
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`Page
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`INTRODUCTION AND REQUESTED RELIEF .......................................... 1
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`II.
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`STATEMENT OF MATERIAL FACTS ........................................................ 1
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`A.
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`The First Petition ................................................................................... 1
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`B.
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`C.
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`The Second Petition............................................................................... 2
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`Interim Events Involving the Challenged Subject Matter ..................... 4
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`III. ARGUMENT ................................................................................................... 7
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`A.
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`Joinder is Appropriate ........................................................................... 7
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`B.
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`C.
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`At Minimum, Ground 3 Should Be Joined ........................................... 8
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`A Final Written Decision in the Joined Proceedings can
`be made within a Year from Institution .............................................. 11
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`D.
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`Joinder will Simplify Discovery and Briefing .................................... 13
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`IV. CONCLUSION .............................................................................................. 14
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`IPR2014-00998 | Patent 8,475,832
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`Docket No. 117744-00048
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`I.
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`INTRODUCTION AND REQUESTED RELIEF
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`Petitioner, BioDelivery Sciences International, Inc. (“BDSI”), requests
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`joinder of IPR2014-00998 with IPR2014-00325. Both proceedings involve the
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`same patent, the same claims, the same parties, and overlapping prior art. Joinder
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`will not unduly delay the resolution of either proceeding. Joinder of at least
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`Ground 3 will significantly simplify the instituted proceeding by eliminating at
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`least three lines of argument already advanced by Patent Owner in its Preliminary
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`Response. Joinder will also avoid unnecessary duplication by resolving numerous
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`issues in common between the two proceedings.
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`BDSI is willing to file a motion limiting its petition in IPR2014-00998 to
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`Ground 3 if the Board so advises to render joinder more feasible. See ABB Inc. v.
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`Roy-G-Biv Corp., IPR2013-00286, Paper 14, Aug. 9, 2013, at 2-3. As instructed
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`by the Board on August 26, BDSI will work with Patent Owner to develop an
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`agreed-upon proposed schedule for the joined proceeding, and will agree to all
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`reasonable requests.
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`II.
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`STATEMENT OF MATERIAL FACTS
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`A. The First Petition
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`On January 15, 2014, BDSI filed a first Petition for Inter Partes Review
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`requesting review of claims 15-19 of the ’832 patent (“First Petition”), designated
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`IPR2014-00325. The First Petition requested cancellation of claims 15-19 on the
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`following grounds among others:
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`Ground 5 Anticipated by Labtec
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`Ground 6 Obvious over Labtec
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`Ground 7 Obvious over Labtec and Birch
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`Ground 8 Obvious over Labtec, Birch, and Yang
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`Ground 9 Anticipated by Euro-Celtique
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`Ground 10 Obvious over Euro-Celtique
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`Ground 11 Obvious over Euro-Celtique and Birch
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`Ground 12 Obvious over Euro-Celtique, Birch, and Yang
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`On July 29, 2014, the Board issued a decision in IPR2014-00325 instituting
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`trial of claims 15-19 on Grounds 5 and 8 (i.e., anticipation by Labtec and
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`obviousness over Labtec, Birch, and Yang). See IPR2014-00325, Paper No. 17, at
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`17, 20. The Board found Grounds 6-7 and 9-12 to be redundant in light of its
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`decision to institute review on Grounds 5 and 8. See id. at 17, 20.
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`B.
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`The Second Petition
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`On June 20, 2014—more than one month before the Board issued its
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`institution decision in IPR2014-00325—BDSI filed the instant Petition for Inter
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`Partes Review (“Second Petition”), which initiated IPR2014-00998. In the Second
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`Petition, BDSI requests cancellation of claims 15-19 of the ‘832 patent on each of
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`the following grounds:
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`Ground 1 Obvious over Euro-Celtique
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`Ground 2 Obvious over Euro-Celtique and the EMEA Study Report
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`Ground 3 Obvious over Euro-Celtique, the EMEA Study Report, and WO
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`03/030883
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`Ground 4 Obvious over Euro-Celtique, the EMEA Study Report, and Yang
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`While the EMEA Study Report (Ex. 1015 in both petitions) was not applied
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`as a secondary reference in the First Petition, it was applied to evidence the known
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`pharmacokinetic parameters of naloxone resulting from administration of the prior
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`art SUBOXONE® tablets. IPR2014-00325, Paper No. 8, at 49.
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`Patent Owner, if not already well aware of the EMEA Study Report—which
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`is a study of Patent Owner’s own SUBOXONE® tablets prepared by the European
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`equivalent of the drug arm of the US FDA—was made aware of that reference in
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`the First Petition over eight months ago. Indeed, the Board refers to the EMEA
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`Study Report in its Institution Decision. See IPR2014-00325, Paper No. 17, at 14
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`(citing EMEA Study Report as “Suboxone Tablet Study Report”).
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`Both petitions cite the EMEA Study Report for the same reason—as
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`evidencing the known naloxone in vivo plasma profile produced by administration
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`of the Patent Owner’s SUBOXONE® tablets. Compare, e.g., IPR2014-00325,
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`Paper No. 8, at 49 (citing EMEA Study Report as “Suboxone Tablet Study Report”)
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`with IPR2014-00998, Paper No. 2, at 45-46.
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`In support of the Second Petition, BDSI filed the Declarations of Dr.
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`Maureen Reitman (Ex. 1004) and Dr. Phillip Lavin (Ex. 1005) that were submitted
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`in the First Petition. The Second Petition also added a new Declaration of Dr.
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`Metin Çelik (Ex. 1033).
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`C.
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`Interim Events Involving the Challenged Subject Matter
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`After the filing of the First Petition, the Office relied on incomplete
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`statements and omissions of the Patent Owner during the prosecution of almost
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`identical claims in the continuation of the ‘832 patent.
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`Published claim 1 of US Patent Application No. 13/964,975 is substantially
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`identical to the sole independent claim challenged in the First Petition, i.e., claim
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`15 of the ‘832 patent. See Ex. 1026, US 2014/0005218 (“the ‘975 application”). A
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`comparison of published claim 1 of the ‘975 application with issued claim 15 of
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`the ‘832 patent follows:
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`151. An orally dissolving film formulation comprising from about 2
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`to about 16 mg of buprenorphine and from about 0.5 to about 4 mg of
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`naloxone, wherein said formulation provides an in vivo plasma profile
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`having a mean Cmax of between about 0.6240.6 ng/ml and about
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`5.6385.7 ng/ml for buprenorphine and an in vivo plasma profile
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`having a mean Cmax of between about 41.0441 pg/ml to about
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`323.75324 pg/ml for naloxone.
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`The recitations of the amounts of buprenorphine and naloxone in published claim 1
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`are the same as those in challenged claims 18 and 19 of the ‘832 patent.
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`In response to a rejection of claim 1 of the ‘975 application as obvious over
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`Euro-Celtique alone, Patent Owner argued Euro-Celtique “fails to provide any
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`disclosure of how to make such films including both buprenorphine and naloxone.”
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`Ex. 1028, Amendment and Response to OA in ‘975 App., Jan. 2, 2014, at 9 (citing
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`Euro-Celtique as “Oksche”).
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`But Euro-Celtique does provide a disclosure of how to make such film
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`including both buprenorphine and naloxone. Euro-Celtique identifies WO
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`03/030883 as describing “standard technology” for preparing films. See Ex. 1018,
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`Euro-Celtique, at 13 (“[T]echnology … to provide the afore-described dosage
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`forms of buprenorphine and ... naloxone is described in WO 03/030883…. The
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`films are prepared according to standard technology and the active agents are
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`displaced thereon and therein as described in WO 03/030883.”).
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`Patent Owner did not disclose to the Office that WO 03/030883 includes the
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`same disclosure of film-making processes as US Patent No. 7,425,292 (the “‘292
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`patent”) and that the ‘832 patent incorporates the ‘292 patent by reference for
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`disclosure of film-making processes. Compare Ex. 1031, WO 03/030883, with Ex.
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`1023, the ‘292 patent (incorporated by reference into the ‘832 patent at 15:30-31).
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`Gary Myers is an inventor of the ‘832 patent, the ‘292 patent, and WO
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`03/030883. Gary Myers is also the former owner of Kosmos Pharma, which is the
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`assignee of WO 03/030883 and the entity that ultimately became MonoSol Rx.
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`MonoSol is the original assignee of the ‘832 patent and the current assignee of the
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`‘292 patent. Thus, Applicant for the ‘975 application should have been well aware
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`of these disclosures and relationships.
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`Due to Patent Owner’s omission, the Office was not aware that Euro-
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`Celtique cites MonoSol/Patent Owner’s film-making processes—the allegedly
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`missing technology—as “standard technology.” On March 7, 2014, in response to
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`the Patent Owner’s arguments, the Office revised its previous rejection to cite a
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`secondary reference to provide the film-making processes, even though such
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`processes were already cited as standard technology in Euro-Celtique. See OA in
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`‘975 App., March 7, 2014, at 4 (¶11) (citing Euro-Celtique as “Oksche et al.” and
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`another Myers/MonoSol/Patent Owner patent as “US Patent No. 7,357,891”).
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`Second, Patent Owner argued Euro-Celtique “is completely devoid of any
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`teaching of Cmax values for naloxone.” Ex. 1028, Amendment and Response to OA
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`in ‘975 App., Jan. 2, 2014, at 9 (citing Euro-Celtique as “Oksche”). Patent Owner
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`did not disclose that the naloxone Cmax values produced by administration of its
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`own prior art SUBOXONE® tablets were well known and readily ascertainable
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`prior to the first priority date of the ‘832 patent. The values were published, for
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`example, in the EMEA Study Report. See Ex. 1015.
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`Unaware that the naloxone Cmax values were known and readily available,
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`the Office cited a third reference to demonstrate that a skilled person would have
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`been motivated to modify the prior art by routine experimentation to produce a
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`film bioequivalent to SUBOXONE® tablets. See Ex. 1029, OA in ‘975 App.,
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`March 7, 2014, at ¶ 20.
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`III. ARGUMENT
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`The Board has the authority under 35 USC §315(c) to join IPR2014-00998
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`with IPR2014-00325. In determining whether and when to allow joinder, the
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`Office may consider factors including “the breadth or unusualness of the claim
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`scope” and claim construction issues. See 157 CONG. REC. S1376 (daily ed. Mar.
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`8, 2011) (statement of Sen. Kyl). The Board has advised:
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`A motion for joinder should: (1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted
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`in the petition; (3) explain what impact (if any) joinder would have on
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`the trial schedule for the existing review; and (4) address specifically
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`how briefing and discovery may be simplified.
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`See IPR2013-00495, Paper 13, at 3.
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`A.
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`Joinder is Appropriate
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`In Ariosa Diagnostics v. Isis Innovation Ltd., the Board joined proceedings
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`involving (i) the same parties, (ii) the same patent, (iii) related claims, (iv)
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`overlapping prior art, and (v) overlapping declarants. See, e.g., IPR2013-00250,
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`Paper 24 (Sept. 3, 2013).
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`Here, both proceedings involve (i) the same parties, and challenge (ii) the
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`same patent and (iii) the same claims of that patent. The proceedings involve
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`(iv) overlapping prior art; the only “new” reference, WO 03/030883, is a disclosure
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`by the original assignee and one of the inventors of the ‘832 patent, and is
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`substantially identical in all relevant respects to a reference cited in the First
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`Petition. Finally, the proceedings involve (v) overlapping declarations, namely,
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`the declarations of Drs. Reitman and Lavin. Each of these facts favors joinder.
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`B. At Minimum, Ground 3 Should Be Joined
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`Because it is not the Board’s job to pour over every reference to glean facts
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`that are well known to Patent Owner—such as the published pharmacokinetic
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`parameters of Patent Owner’s own prior art products, or the citation in the prior art
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`to a reference cited in the ‘832 patent as “standard technology” for film-making—
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`BDSI provides Ground 3. Ground 3 will moot Patent Owner’s arguments that
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`depend entirely on the Board’s lack of knowledge of key facts—arguments already
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`made by Patent Owner in its Preliminary Response. See, e.g., PO Prelim. Resp. in
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`IPR2013-00998, Paper 15, Apr. 30, 2014, at 25-26 (argument regarding lack of
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`enabling disclosure in both Euro-Celtique and Labtec).
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`The Board found the grounds in the First Petition applying Euro-Celtique as
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`a primary reference to be redundant to the grounds applying Labtec. But this does
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`not preclude the Board from joining IPR2014-00998 and IPR2014-00325. Indeed,
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`the fact that Euro-Celtique and the EMEA Study Report are exhibits to the First
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`Petition favors joinder. See ABB Inc. v. Roy-G-Biv Corp., IPR2013-00286, Paper
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`No. 14, Aug. 19, 2013, at 3-4 (“Substantive issues in this IPR would not be unduly
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`complicated by joining with [first proceeding] because the joinder introduces only
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`two pieces of new prior art (both of which are exhibits in [first proceeding]).”).
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`Also favoring joinder is that the only “new” prior art reference in the Second
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`Petition (i.e., WO 03/030883), is cited for the same relevant disclosure as a related
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`family member cited in the First Petition (i.e., Yang).
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`Joinder will moot Patent Owner’s new and unexpected line of argument that
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`the prior art is not enabling. Ground 3 of the Second Petition applies WO
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`03/030883 (Ex. 1031) as a secondary reference, a reference that Patent Owner
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`made relevant by arguing that the cited prior art is not enabling with respect to
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`making the disclosed film formulations.1 Euro-Celtique cites WO 03/030883 as
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`1
`Although WO 03/030883 was not asserted as invalidating prior art in the
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`First Petition, this reference is neither new nor unfamiliar to Patent Owner. WO
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`03/030883 is assigned on its face to Kosmos Pharma, which became MonoSol.
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`Gary Myers, the Senior Director of Product Development at MonoSol, and former
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`owner of Kosmos Pharma, is a named inventor of both WO 03/030883 and the
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`‘832 patent. He is also a named inventor of the two US patents incorporated by
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`reference in the ‘832 patent for disclosing methods of making films with
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`buprenorphine and naloxone.
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`disclosing “standard technology” for film-making. Ex. 1018, at 13. The disclosure
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`of film-making in WO 03/030883 is the same disclosure that the ‘832 patent
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`incorporates by reference via its related patent family members. Joining grounds
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`based on Euro-Celtique will likely eliminate this entire line of argument because it
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`is doubtful that Patent Owner will argue that its own film-making disclosure is not
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`enabling.
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`Similarly, joinder will preclude Patent Owner from pursuing its meritless
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`argument that the pharmacokinetic profile of naloxone resulting from
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`administration of SUBOXONE® was not disclosed. Grounds 2-4 of the Second
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`Petition apply the EMEA Study Report—a study of Patent Owner/RBP’s own
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`SUBOXONE® tablets—as a secondary reference.
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`BDSI cited the EMEA Study Report in the First Petition (as “Suboxone
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`Tablet Study Report”) for the same proposition for which it is cited in the Second
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`Petition, i.e., that the pharmacokinetic profile resulting from the administration of
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`SUBOXONE® tablets was known in the art before the claimed priority date of the
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`‘832 patent. Compare IPR2014-00325, Paper 1, at 28 with IPR2014-00998, Paper
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`1, at 45 (both citing the EMEA Study Report for its disclosure of naloxone Cmax and
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`AUC values resulting from administration of SUBOXONE tablets).
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`Patent Owner has taken the position that Euro-Celtique does not render the
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`claimed film formulations unpatentable because it is silent as to the Cmax of
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`naloxone—as if such commonly known features of a commercial pharmaceutical
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`product were not known. The Cmax of naloxone was well known and readily
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`ascertainable from publicly available documents, including the EMEA Study
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`Report. The new grounds applying the EMEA Study Report are non-redundant
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`because the EMEA Study Report explicitly discloses the naloxone Cmax resulting
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`from administration of SUBOXONE® tablets. Joinder of grounds based on the
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`EMEA Study Report is likely to eliminate many disputes in the First Proceeding
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`over what was known in the prior art, particularly what was known about
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`SUBOXONE® tablets, the product Patent Owner admits it was copying in the ‘832
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`patent.
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`Finally, the Patent Owner has raised the issues of whether the claims require
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`the film formulation to be mucoadhesive—even though mucoadhesive is not
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`recited in the claims—and whether Labtec teaches or suggests a mucoadhesive
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`film formulation. See IPR2014-00325, Paper No. 15, at 30-31. Euro-Celtique
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`explicitly discloses mucoadhesive film formulations. See, e.g., Exhibit 1018, at
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`18-19, claim 8. Joining grounds based on Euro-Celtique is likely to eliminate this
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`entire line of argument.
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`C. A Final Written Decision in the Joined Proceedings can be made
`within a Year from Institution
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`In Ariosa, the joined proceedings were initiated over six months apart. The
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`instant proceedings were initiated five months apart. In Ariosa, the Board found
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`“joinder … will not delay unduly the resolution of either proceeding, but will help
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`‘secure the just, speedy, and inexpensive resolution’ of these proceedings.”
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`Ariosa, IPR2013-00250, Paper 24, at 4. In Ariosa, the Board also found that
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`joinder of the proceedings will allow for a single deposition, rather than multiple
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`depositions, of the same witnesses. Id. The same is true here.
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`Joinder will not unduly delay the trial schedule in IPR2014-00325. As
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`instructed by the Board on August 26, BDSI will work with Patent Owner to
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`develop an agreed-upon proposed schedule for the joined proceeding. BDSI will
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`accommodate any reasonable logistical or scheduling request of Patent Owner in
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`order to accommodate joinder of the proceedings. Indeed, BDSI has already
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`agreed to a substantial extension requested by Patent Owner. Patent Owner has
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`already indicated that it will not move to amend the challenged claims, which
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`allows for additional flexibility in the schedule of IPR2013-00325. Further, the
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`current schedule in IPR2014-00325 could be extended to accommodate any
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`additional briefing required in light of any new ground asserted in the Second
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`Petition and remain well within the one-year deadline for final written decision in
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`IPR2014-00325.2
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`2
`Although BDSI does not believe such measures will be necessary in this
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`matter, BDSI notes that the Board is expressly authorized by statute to extend the
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`To the extent the Board finds that joinder of multiple grounds in the Second
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`Petition would unduly delay the instituted proceeding, Ground 3 is sufficient to
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`streamline the instituted IPR2014-00325.
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`Finally, joinder will not otherwise unduly prejudice the Patent Owner. As
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`noted above, the matters involve the same patent, same claims, same parties,
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`overlapping prior art, and many of the same arguments. Indeed, as Patent Owner
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`argued in its Mandatory Notice responsive to the Second Petition:
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`The [Second] Petition is substantially redundant of the petition filed
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`by the same petitioner in IPR2014-00325 . . . . The [Second] Petition
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`is directed to the same claims of the patent as the earlier petition,
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`involves the same parties, asserts the same or substantially the same
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`contentions, and is based on a subset of the references cited in the
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`earlier petition.
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`IPR2014-00998, Paper 5, July 11, 2014, at 2-3. Patent Owner’s admission of the
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`extensive overlap between the two petitions indicates that, to the extent the Second
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`Petition adds substantive issues to the instituted IPR2014-00325, joinder would not
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`be unduly burdensome to Patent Owner.
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`D.
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`Joinder will Simplify Discovery and Briefing
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`Joinder will significantly simplify briefing and discovery. Patent Owner has
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`schedule for trial beyond the one year deadline for a final decision in cases of
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`joinder. See 35 U.S.C. § 316(a)(11); 37 C.F.R. § 42.100(c).
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`already indicated in its Preliminary Response that it will raise the following issues:
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`(1) claim construction; (2) relevance of two declarations, those of Drs. Reitman
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`and Lavin, submitted in both proceedings; (3) the foundation of the Reitman
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`Declaration; (4) the level of skill in the art; (5) what was known in the art; (6) what
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`is required for enablement of prior art references; (7) whether Patent Owner and/or
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`MonoSol are pioneers; (8) the characteristics of Patent Owner’s prior art
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`SUBOXONE® tablet and their relevance; (9) the complexity of the technology;
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`and (10) secondary considerations, such as commercial success. Based on the
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`similarity of the two petitions, it is reasonable to assume the Patent Owner will also
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`raise the ten foregoing issues in IPR2014-00998.
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`In addition to Patent Owner’s ten foregoing issues, the Board must resolve
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`the issue of how to address the recited desired results of an unrecited method of
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`administration in the challenged claims. Compare IPR2014-00325, Paper 8, at 22-
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`26, with IPR2014-00998, Paper 2, at 30-32.
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`Absent joinder, the Board must consider each of these issues twice. Joinder
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`will thus enhance efficiency by consolidating issues, minimizing duplication of the
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`Board’s efforts, and preventing inconsistencies among the proceedings.
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`IV. CONCLUSION
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`As explained above, there is good cause for joining the instant proceeding
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`with IPR2014-00325 because joinder would ensure the just, speedy, and
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`inexpensive resolution of both proceedings. Accordingly, BDSI requests joinder
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`of IPR2014-00998 with IPR2014-00325.
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`Dated: August 29, 2014
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`Respectfully submitted,
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`By: /Danielle L. Herritt/
`Danielle Herritt (Reg. No. 43,670)
`Kia Freeman (Reg. No. 47,577)
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`ME1 18622541v.1
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`-15-
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`Page 17
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`IPR2014-00998 | Patent 8,475,832
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`Docket No. 117744-00048
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Motion for
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`Joinder was served on August 29, 2014, by transmitting a copy to lead counsel
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`James Bollinger at james.bollinger@troutmansanders.com and to backup counsel
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`Daniel Ladow at daniel.ladow@troutmansanders.com in accordance with the
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`consent set forth in Patent Owner Mandatory Notice Information.
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`By:
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`/Danielle L. Herritt/
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`Danielle L. Herritt
`Registration No. 43,670
`Attorney for Petitioner
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`ME1 18622541v.1
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`Page 18
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