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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`INDIVIOR INC.
`Petitioner
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`v.
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`RHODES PHARMACEUTICALS L.P.
`Patent Owner
`
`_____________________
`
`Case IPR2018-00795
`Patent 9,370,512
`_____________________
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`PATENT OWNER'S SURREPLY TO PETITIONER'S REPLY
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`
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`
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`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
` IPR2018-00795
`Patent No. 9,370,512
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`As authorized in Paper 19, Patent Owner Rhodes Pharmaceuticals L.P.
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`submits this Surreply to Petitioner's Reply filed August 7, 2018.
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`Petitioner's Reply does not change the Board's analysis under 35 U.S.C. §
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`325(d). A full-length English language version of the Cremer reference cited by
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`Petitioner (EX1004) was cited during prosecution of the subject U.S. Patent No.
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`9,370,512 ("the '512 patent") and was discussed in detail during the prosecution of
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`the parent patent before the same Examiner (CA 2,274,910 "Cremer CA;"
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`EX2002; see POPR at 8). The Examiner, fully aware of the teachings of Cremer,
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`found the claims of the '512 patent to be patentable. The Board should exercise its
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`discretion under § 325(d) and deny institution of inter partes review.
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`I. The Examiner Was Aware of the Teachings of Cremer CA
`It is undisputed that Cremer CA was of record in the prosecution history of
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`the '512 patent and its parent, U.S. Patent No. 9,101,625 ("the '625 patent"). See
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`POPR at 8 and 19-20; Reply at 2, fn. 2. The Examiner noted in each Information
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`Disclosure Statement where Cremer CA was cited that the reference was
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`considered. POPR at 8 and 19-20; EX2009 at 3; EX1002 at 58. Moreover, the
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`prosecution history of a parent application is considered part of the file history of
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`the child application. See Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1333
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`IPR2018-00795
`Patent No. 9,370,512
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`(Fed. Cir. 2003); POPR at 6. The disclosures of Cremer CA were discussed on the
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`record during prosecution of the '625 patent. POPR at 6-19. Further, the Office
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`Actions from prosecution of the '625 patent were considered by the Examiner
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`during prosecution of the '512 patent. EX1002 at 204-205. Thus, these disclosures
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`in Cremer CA are part of the prosecution history of the '512 patent.
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`As such, the record shows that the Examiner of the '512 patent was well
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`aware of the teachings of Cremer CA when he allowed the claims of the '512
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`patent. Nothing in Petitioner's Reply casts doubt on this conclusion.
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`II.
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` § 325(d) Only Requires that Substantially the Same Art from the
`Petition Was Applied During Prosecution
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`The German language Cremer PCT (WO1998/26780) was formally cited as
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`an anticipating reference during prosecution. EX1003, 142-144. While Petitioner
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`applies Cremer in an obviousness context, Section 325(d) gives the Board
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`discretion when "the same or substantially the same prior art or arguments
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`previously were presented to the Office." 35 U.S.C. § 325(d), emphasis added. The
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`Board has confirmed that it may exercise its discretion when substantially the same
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`art was presented during prosecution even if substantially the same arguments were
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`not. See, e.g., R.J. Reynolds Vapor Company v. Fontem Holdings 1 B.V., IPR2017-
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`IPR2018-00795
`Patent No. 9,370,512
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`01118, Paper 8 (October 4, 2017) at 4-5. Thus, the fact that Cremer was applied as
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`an anticipating reference during prosecution does not preclude the Board from
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`denying institution under § 325(d). Instead, as discussed in the POPR and further
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`below, the way Cremer was considered during prosecution warrants denial.
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`III. The Examiner Fully Considered the Teachings of Cremer CA/PCT
`As discussed in the POPR, to address the rejection over Cremer PCT during
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`prosecution of the '625 patent, Applicant contrasted the teachings of Cremer CA
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`with the claims pending at the time in a response filed October 22, 2012. Applicant
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`argued that Cremer CA did not disclose that the buprenorphine was "dissolved or
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`homogeneously dispersed" in the dosage form, as was recited in then-pending
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`claim 1. POPR at 10-13; EX1003 at 98-100. And Applicant not only addressed the
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`pending anticipation rejection, but also provided arguments as to how the pending
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`claims were nonobvious over Cremer. POPR at 11-13; EX1003 at 100-103. The
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`Examiner was certainly aware of Applicant's arguments regarding Cremer, as he
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`issued an Advisory Action in response. EX1003 at 86-88.
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`Subsequent to the Advisory Action, Applicant filed an Amendment on
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`March 21, 2013, ("March 21 claims") that included new independent claim 21 and
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`claim 30 that depended from claim 21 and recited that the buprenorphine was
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`IPR2018-00795
`Patent No. 9,370,512
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`"dissolved or homogeneously dispersed" in the film. POPR at 13-19; EX1003 at
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`75-84. As shown in the POPR, the elements of claim 30 are substantially similar to
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`those of claim 1 of the subject '512 patent. POPR at 13-17. Applicant argued that
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`previously-pending claim 1 should have been allowable over Cremer for reasons of
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`record, but also provided additional reasons why new claim 21 was distinguishable
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`from Cremer. POPR at 17; EX1003 at 83.
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`In the next Office Action, the Examiner noted that the arguments filed on
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`March 21, 2013 had been considered and that rejections not reiterated were
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`withdrawn. POPR at 17; EX1003 at 68. This Office Action did not include any
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`rejection based on Cremer, indicating that the Examiner did not find Cremer to be
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`applicable to the pending claims. EX1003 at 66-74. Because one of the previously-
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`pending rejections was based on Cremer and was withdrawn, the Examiner must
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`have considered the claims filed on March 21, 2013 in view of Cremer.
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`Petitioner states that only the "mucoadhesive properties" distinguished the
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`March 21 claims from Cremer and that the Examiner did not find that the
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`"dissolved or homogenously dispersed" element of the claims was not taught by
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`Cremer. Reply at 4. But there is no evidence in the record supporting Petitioner’s
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`assertion. Claim 21 of the March 21 claims recited that the "dosage form is in the
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`IPR2018-00795
`Patent No. 9,370,512
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`form of a film or has mucoadhesive properties." EX1003 at 76, emphasis added.
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`Thus, if the Examiner believed that Cremer taught a film dosage form, the
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`Examiner would have applied Cremer in a subsequent rejection regardless of
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`whether Cremer taught mucoadhesive properties. But the Examiner did not apply
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`Cremer to the March 21 claims. This mucoadhesive element was also later
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`removed from the claims during prosecution of the '625 patent and the Examiner
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`did not reapply Cremer. EX1003 at 59. The claims of the '512 patent recite film
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`formulations and the Examiner found them patentable over Cremer as well.
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`The prosecution history of the '625 parent patent discussed and considered
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`Cremer in full, and is part of the prosecution history of the subject '512 patent.
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`Moreover, both patents were examined by the same Examiner. The Examiner was
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`well aware of the disclosures of the Cremer reference and found the claims of the
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`'512 patent allowable over Cremer. Petitioner has not established that the Examiner
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`erred in any way. And Petitioner has not addressed any of the other Becton factors
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`relevant to §325(d) that weigh heavily in favor of non-institution. See POPR at 25-
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`33. For the reasons in the POPR and in this Surreply, the Board should exercise its
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`discretion and deny institution of inter partes review, because the Office has
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`already considered substantially the same art cited in the Petition.
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`IPR2018-00795
`Patent No. 9,370,512
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`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`/Eldora L. Ellison/
`Eldora L. Ellison
`Registration No. 39,967
`Lead Attorney for Patent Owner
`
`
`
`
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`Date: August 14, 2018
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`9789963_1.docx
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the above-captioned "Patent Owner's
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`Surreply to Petitioner's Reply" was served in its entirety on August 14, 2018, upon
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`the following parties via electronic mail:
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`Carol Pitzel Cruz
`Christie R.W. Matthaei
`William R. Zimmerman
`Knobbe, Martens, Olson & Bear, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 926142
`2CMP@knobbe.com
`2CRW@knobbe.com
`BoxIndivior@knobbe.com
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`
` /Eldora L. Ellison/
`Eldora L. Ellison
`Registration No. 39,967
`Lead Attorney for Patent Owner
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`Date: August 14, 2018
`1100 New York Avenue, N.W.
`Washington, D.C. 20005
`(202) 371-2600
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