UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`NOVEN PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`___________________
`
`Inter Partes Review No.: IPR2014-00550
`
`U.S. Patent No. 6,335,031
`
`PETITIONER’S MOTION TO CORRECT PETITION AND EXHIBITS
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`NOVEN PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`___________________
`
`Inter Partes Review No.: IPR2014-00550
`
`U.S. Patent No. 6,335,031
`
`PETITIONER’S MOTION TO CORRECT PETITION AND EXHIBITS
`
`
`
`Petitioner Noven Pharmaceuticals, Inc. respectfully moves the Board to
`
`correct certain clerical and typographic errors in its petition for inter partes review
`
`(Paper 1), Exhibits 1007, 1010, 1011, 1019, and 1020 as set forth below.
`
`On October 28, 2014, Patent Owners Novartis AG and LTS Lohmann
`
`Therapie-Systeme AG (“Patent Owners”) served objections pursuant to 37 C.F.R.
`
`§ 42.64(b)(1) to all of Petitioner’s exhibits except the challenged patent and its file
`
`wrapper. Patent Owners’ objections included (i) general evidentiary objections
`
`and (ii) specific objections due to the clerical and typographical errors addressed
`
`herein. During the initial conference call with the Board, held on October 30,
`
`2014, Petitioner sought guidance from the Board regarding responding to the
`
`objections. The Board counseled that Petitioner may respond to Patent Owners’
`
`objections by serving supplemental evidence and if the parties agree that the
`
`supplemental evidence cures the alleged defect in the evidence, the parties were
`
`directed to seek authorization to file a motion to correct the relevant exhibit(s) or
`
`paper(s). Paper 14 at 4. On November 12, 2014, Pursuant to 37 C.F.R. §
`
`42.64(b)(2), Petitioner provided a list of corrections to address Patent Owners’
`
`specific objections and reserved the right to respond to Patent Owners’ general
`
`objections should they file a motion to exclude under C.F.R. § 42.64(c). Patent
`
`owners agreed that the proposed amendments corrected the clerical and
`
`typographical errors in a communication dated November 19, 2014, and stated that
`
`2
`
`
`
`they will not oppose a motion to correct the clerical and typographical errors in an
`
`email dated December 9, 2014. Petitioner sought permission to file this unopposed
`
`motion, which was granted in an email from the Board on December 10. Petitioner
`
`has provided this motion and the corrected petition and exhibits to Patent Owners,
`
`and Patent Owners have stated that they do not oppose this motion. Patent
`
`Owners, however, maintain all objections that are not specifically addressed below
`
`in this motion.
`
`By this motion, Petitioner seeks to correct the following clerical and
`
`typographical errors:
`
`Petition for Inter Partes Review of U.S. Patent 6,335,031 (Paper 1)
`
`To address, in part, Patent Owners’ objections, Petitioner requests
`
`permission to correct its Petition for Inter Partes Review of U.S. Patent 6, 335,031
`
`with the following corrections to the List of Exhibits (Paper 1 at iii-v):
`
`(1)
`
`The list of exhibits on page iii incorrectly refers to Ex. 1007 as “Carey
`
`& Sundberg, ADVANCED ORGANIC CHEMISTRY, 2nd ed. Part A: Structure
`
`and Mechanism, Plenum Press, New York, 1984, pp. 652.” The correct citation is
`
`“Carey & Sundberg, Advanced Organic Chemistry, Part A: Structure and
`
`Mechanism, 3rd Edition (Plenum Press, NY), pp. 651-727 (1990).”
`
`3
`
`
`
`(2)
`
`The list of exhibits on page v incorrectly refers to Ex. 1017 as “Ho-
`
`Leung Fung, Chapter 7 – Chemical Kinetics and Drug Stability in MODERN
`
`PHARMACEUTICS (G.S. Banker and C.T. Rhodes, eds.), Marcel Dekker, NY
`
`(1978), pp. 227-62.” The correct citation is “Ho-Leung Fung, Chapter 7 –
`
`Chemical Kinetics and Drug Stability in MODERN PHARMACEUTICS (G.S.
`
`Banker and C.T. Rhodes, eds.), Marcel Dekker, NY (1979), pp. 227-62.”
`
`(3)
`
`The list of exhibits on page v incorrectly refers to Ex. 1021 as
`
`“Linnell, R.H., The Oxidation of Nicotine. I. Kinetics of the Liquid Phase Reaction
`
`Near Room Temperature. Tobacco Science, Vol. 4, pp. 89–90 (1960).” The
`
`correct citation is “Linnell, R.H., The Oxidation of Nicotine. I. Kinetics of the
`
`Liquid Phase Reaction Near Room Temperature. Tobacco Science, Vol. 4, pp. 89–
`
`91 (1960).”
`
`Exhibit 1010
`
`To correct the following clerical error in paragraph 26 of Exhibit 1010
`
`(Declaration of Agis Kydonieus, Ph.D), Petitioner provides Corrected Exhibit
`
`1010, which now includes a Supplemental Declaration of Agis Kydonieus, Ph.D.
`
`dated November 11, 2014, appended to the original Exhibit 1010, identifying the
`
`following correction:
`
`4
`
`
`
`Page 15, paragraph 26: change “(Ex. 1012 at 1; Ex. 1014 at 3.)” to “(Ex.
`
`1012 at 1; Ex. 1013 at 3.)”
`
`See Corrected Exhibit 1010 at 48-49.
`
`Exhibit 1011
`
`To correct the following clerical errors in Exhibit 1011 paragraphs 9, 14, 31,
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`47, and 48 of Exhibit 1011 (Declaration of Christian Schöneich, Ph.D.), Petitioner
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`provides Corrected Exhibit 1011, which now includes a Supplemental Declaration
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`of Christian Schöneich, Ph.D. dated November 11, 2014, appended to the original
`
`Exhibit 1011, identifying the following corrections:
`
`(1) On pages 4 (paragraph 9) and 13-14 (paragraph 31), Ex. 1007 is
`
`incorrectly referred to as “Carey & Sundberg, ADVANCED ORGANIC
`
`CHEMISTRY, 2nd ed. Part A: Structure and Mechanism, Plenum Press, New
`
`York, 1984, pp. 652.” The correct language is “Carey & Sundberg, Advanced
`
`Organic Chemistry, Part A: Structure and Mechanism, 3rd Edition (Plenum Press,
`
`NY), pp. 651-727 (1990).”
`
`(2) On pages 5 (paragraph 9) and 19 (paragraph 48), Ex. 1021 is
`
`incorrectly referred to as “Linnell, R.H., The Oxidation of Nicotine. I. Kinetics of
`
`the Liquid Phase Reaction Near Room Temperature. Tobacco Science, Vol. 4, pp.
`
`89–90 (1960).” The correct citation is “Linnell, R.H., The Oxidation of Nicotine.
`
`5
`
`
`
`I. Kinetics of the Liquid Phase Reaction Near Room Temperature. Tobacco
`
`Science, Vol. 4, pp. 89–91 (1960).”
`
`(3) On pages 4 (paragraph 9) and 8 (paragraph 14), Ex. 1017 is
`
`incorrectly referred to as “Ho-Leung Fung, Chapter 7 – Chemical Kinetics and
`
`Drug Stability in MODERN PHARMACEUTICS (G.S. Banker and C.T. Rhodes,
`
`eds.), Marcel Dekker, NY (1978), pp. 227-62.” The correct citation is “Ho-Leung
`
`Fung, Chapter 7 – Chemical Kinetics and Drug Stability in MODERN
`
`PHARMACEUTICS (G.S. Banker and C.T. Rhodes, eds.), Marcel Dekker, NY
`
`(1979), pp. 227-62.”
`
`(4) On page 19, paragraph 47, the Boccardi reference is incorrectly cited
`
`as “Exhibit 1020” and should be “Exhibit 1019.”
`
`See Corrected Exhibit 1011 at 35-37.
`
`Exhibit 1007
`
`Patent Owners objected to Exhibit 1007, inter alia, because certain pages
`
`have underlined text. While the text is not obscured, Petitioner provides a clean
`
`replacement copy of Exhibit 1007 to address Patent Owners’ objection.
`
`6
`
`
`
`Exhibit 1019 and 1020
`
`To address, in part, Patent Owner’s objections to Exhibits 1019 and 1020,
`
`Petitioner is providing a replacement Exhibit 1019, which contains the correct
`
`cover page, and a replacement Exhibit 1020 that has the cover pages for that 1954
`
`journal article.
`
`The above-listed corrections address clerical and typographical errors, and
`
`do not affect the opinions and arguments set forth in the petition or expert
`
`declarations.
`
`Dated: December 31, 2014
`
`Respectfully submitted,
`
` /Steven J. Lee/
`Steven J. Lee (Reg. No. 31,272)
`Michael K. Levy (Reg. No. 40,699)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`Counsel for Petitioner Noven
`Pharmaceuticals, Inc.
`
`7
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that, on this 31st day of December, 2014, the foregoing Petitioner’s
`
`Motion to Correct Petition and Exhibits was served electronically on the Patent
`
`Owner using the following address:
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`ExelonPatchIPR@fchs.com
`
` /Michael K. Levy/
` Michael K. Levy
`
`8
`
`
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