UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`
`LANNETT HOLDINGS, INC.,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`____________________________________________
`
`Case: IPR2015-01629
`U.S. Patent No. 6,750,237
`
`____________________________________________
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`

`
`Case No. IPR2015-01629
`Patent 6,750,237
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`
`
`
`
`I.
`
`II.
`
`35 U.S.C. § 315(b) Bars the Petition ............................................................... 1
`
`A.
`
`The Petition Was Filed More Than One Year After Petitioner
`Was Served With an Infringement Complaint ...................................... 1
`
`B. No Exception Applies to the Applicability of § 315(b) ........................ 3
`
`1.
`
`2.
`
`3.
`
`Service of Process Complied With the Local and Federal
`Rules ............................................................................................ 3
`
`Patent Owner Had Standing to Bring the First Action ............... 4
`
`The First Infringement Action Was Not Dismissed ................... 5
`
`III. Claim Construction .......................................................................................... 7
`
`A.
`
`B.
`
`Petitioner Inappropriately Incorporates Dr. Gizurarson’s
`Declaration in an Attempt to Circumvent the Page Limit .................... 7
`
`The Terms “Zolmitriptan,” “Buffer,” “Buffered,” and “in a
`Buffer” Should Be Given Their Plain and Ordinary Meanings ............ 8
`
`1.
`
`2.
`
`“Zolmitriptan” ............................................................................. 8
`
`“Buffer,” “Buffered,” and “in a Buffer” ................................... 13
`
`C.
`
`The Preamble Is Limiting .................................................................... 16
`
`IV. Grounds Based on Anticipation ..................................................................... 18
`
`A. Chauveau Does Not Anticipate Claims 1-8, 13, 15, or 16 .................. 19
`
`1.
`
`2.
`
`3.
`
`Chauveau’s Disclosure of Excipients Does Not Disclose
`Buffers ....................................................................................... 19
`
`Chauveau Does Not Disclose Sterile Pharmaceutical
`Formulations ............................................................................. 22
`
`The Claimed pH Range Is Critical ............................................ 23
`
`ii
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`

`
`
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`Case No. IPR2015-01629
`Patent 6,750,237
`
`4.
`
`Chauveau Does Not Disclose All Claim Elements as
`Arranged in the Claims ............................................................. 26
`
`B.
`
`Rudolf Does Not Anticipate Claims 9, 10, or 13 ................................ 28
`
`1.
`
`2.
`
`Rudolf Is Not Prior Art Under § 102(b) ................................... 28
`
`Rudolf Does Not Disclose All Claim Elements as
`Arranged in the Claims ............................................................. 28
`
`C. Marquess Does Not Anticipate Claims 1 or 3-15 ............................... 31
`
`1. Marquess Is Not Prior Art ......................................................... 31
`
`2. Marquess Does Not Disclose All Claim Elements ................... 32
`
`a. Marquess Does Not Disclose Zolmitriptan .................... 32
`
`b. Marquess Does Not Disclose Any Buffered
`Formulation or One Having a pH of 4.5 to 5.5 .............. 34
`
`c. Marquess Does Not Disclose a Sterile Formulation ...... 36
`
`d. Marquess Does Not Disclose a pH of 5 .......................... 36
`
`e. Marquess Does Not Disclose an Intranasal
`Administration Device .................................................... 37
`
`V. Grounds Based on Obviousness .................................................................... 37
`
`VI. Conclusion ..................................................................................................... 38
`
`
`
`
`
`
`
`iii
`
`
`
`
`
`

`
`
`
`Case No. IPR2015-01629
`Patent 6,750,237
`
`TABLE OF AUTHORITIES
`
`
` Page(s)
`
`Cases
`Advanced Display Sys., Inc. v. Kent State Univ.,
`212 F.3d 1272 (Fed. Cir. 2000) .......................................................................... 34
`
`Akamai Techs., Inc. v. Cable & Wireless Internet Servs., Inc.,
`344 F.3d 1186 (Fed. Cir. 2003) .......................................................................... 32
`
`Apple Inc. v. Rensselaer Polytechnic Institute,
`IPR2014-00319, Paper 12 (PTAB June 12, 2014) ........................................... 6, 7
`
`In re Arkley,
`455 F.2d 586 (C.C.P.A. 1972) ................................................................ 18, 27, 30
`
`Atofina v. Great Lakes Chem. Corp.,
`441 F.3d 991 (Fed. Cir. 2006) ................................................................ 23, 25, 26
`
`Baxter Int’l, Inc. v. McGaw, Inc.,
`149 F.3d 1321 (Fed. Cir. 1998) ............................................................................ 3
`
`Bowles v. Russell,
`551 U.S. 205 (2007) .............................................................................................. 2
`
`Cisco Sys., Inc. v. C-Cation Techs., LLC,
`IPR2014-00454, Paper 12 (PTAB Aug. 29, 2014) ............................................... 7
`
`Cisco Sys., Inc. v. Constellation Techs. LLC,
`IPR2014-00914, Paper 11 (PTAB Jan. 2, 2015) ................................................ 31
`
`Cisco Sys., Inc. v. Custom Media Tech. LLC,
`IPR2014-01272, Paper 9 (PTAB Jan. 30, 2015) ................................................ 28
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015) ............................................................................ 8
`
`Daicel Corp. v. Celanese Int’l Corp.,
`IPR2014-01514, Paper 11 (PTAB Apr. 1, 2015) ............................................... 22
`
`iv
`
`

`
`
`Fidelity Nat’l Info. Servs., Inc. v. DataTreasury Corp.,
`IPR2014-00489, Paper 9 (PTAB Aug. 13, 2014) ................................................. 8
`
`Case No. IPR2015-01629
`Patent 6,750,237
`
`Flir Sys., Inc. v. Canvs Corp.,
`IPR2014-00773, Paper 7 (PTAB Sept. 4, 2014) ................................................... 2
`
`GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.,
`No. 11-cv-00046, 2013 U.S. Dist. LEXIS 112440 (D. Del. Aug. 9,
`2013) ................................................................................................................... 10
`
`Graves v. Principi,
`294 F.3d 1350 (Fed. Cir. 2002) ............................................................................ 5
`
`Jack Guttman, Inc. v. Kopykake Enterprises, Inc.,
`302 F.3d 1352 (Fed. Cir. 2002) ............................................................................ 9
`
`KSR Int. Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 38
`
`Lemus v. DOJ,
`571 F. App’x 952 (Fed. Cir. 2014) ....................................................................... 3
`
`Liberty Mutual Ins. Co. v. Progressive Casual Ins. Co.,
`CBM2012-00003, Paper 8 (PTAB Oct. 25, 2012) ............................................. 38
`
`Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co.,
`730 F.2d 1452 (Fed. Cir. 1984) .......................................................................... 27
`
`Macauto U.S.A. v. BOS GmbH & KG,
`IPR2012-00004, Paper 18 (PTAB Jan. 24, 2013) ................................................ 5
`
`In re Meyer,
`599 F.2d 1026 (C.C.P.A. 1979) .................................................................... 20, 21
`
`Microsoft Corp. v. Proxyconn, Inc.,
`789 F.3d 1292 (Fed. Cir. 2015) ............................................................................ 8
`
`Mylan Pharm. Inc. v. Nissan Chem. Indus., Ltd.,
`IPR2015-01069, Paper 24 (PTAB Oct. 20, 2015) .............................................. 21
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .............................................................. 18, 27, 29
`
`v
`
`

`
`
`OSRAM Sylvania, Inc. v. Am. Induction Technologies, Inc.,
`701 F.3d 698 (Fed. Cir. 2012) ................................................................ 24, 25, 26
`
`Case No. IPR2015-01629
`Patent 6,750,237
`
`In re Petering,
`301 F.2d 676 (C.C.P.A. 1962) ............................................................................ 20
`
`Pfizer Inc. v. Teva Pharm. USA, Inc.,
`803 F. Supp. 2d 409 (E.D. Va. 2011) ................................................................... 5
`
`Proveris Scientific Corp. v. Innovasystems, Inc.,
`739 F.3d 1367 (Fed. Cir. 2014) .......................................................................... 16
`
`Rates Tech. Inc. v. Nortel Networks Corp.,
`399 F.3d 1302 (Fed. Cir. 2005) ............................................................................ 4
`
`Rowe v. Dror,
`112 F.3d 473 (Fed. Cir. 1997) ............................................................................ 33
`
`RPX Corp. v. VirnetX Inc.,
`IPR2014-00171, Paper 49 (PTAB June 5, 2014) ................................................. 2
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) .............................................................. 19, 20, 21
`
`Schenck v. Nortron Corp.,
`713 F.2d 782 (Fed. Cir. 1983) ............................................................................ 38
`
`Shaw Indus. Group, Inc. v. Automated Creel Sys., Inc.,
`IPR2013-00132, Paper 44 (PTAB July 24, 2014) ........................................ 36, 37
`
`SkinMedica, Inc. v. Histogen Inc.,
`727 F.3d 1187 (Fed. Cir. 2013) .......................................................................... 34
`
`Symantec Corp. v. RPost Communications Ltd.,
`IPR2014-00357, Paper 14 (PTAB July 15, 2014) .............................................. 33
`
`Tuftco Corp. v. Card-Monroe Corp.,
`IPR2015-00505, Paper 6 (PTAB July 22, 2015) .................................................. 8
`
`Unified Patents, Inc. v. Clouding IP, LLC,
`IPR2013-00586, Paper 12 (PTAB Apr. 22, 2014) ............................................... 2
`
`vi
`
`

`
`
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ............................................................................ 32
`
`Case No. IPR2015-01629
`Patent 6,750,237
`
`Wowza Media Sys., LLC v. Adobe Sys. Inc.,
`IPR2013-00054, Paper 16 (PTAB July 13, 2013) .............................................. 21
`
`Yamaha Corp. of America v. Black Hills Media, LLC,
`IPR2014-00766, Paper 7 (PTAB Nov. 24, 2014) ................................................. 4
`
`Federal Statutes
`
`35 U.S.C. § 102(a) ................................................................................................... 32
`
`35 U.S.C. § 102(b) ............................................................................................. 28, 31
`
`35 U.S.C. § 102(e) ................................................................................................... 31
`
`35 U.S.C. § 102(g) ................................................................................................... 31
`
`35 U.S.C. § 103(a) ................................................................................................... 38
`
`35 U.S.C. § 119(e) ................................................................................................... 31
`
`35 U.S.C. § 122(b) ................................................................................................... 28
`
`35 U.S.C. § 315(b) ............................................................................................passim
`
`State Statutes
`
`Del. Code Ann. tit. 8, § 132 ....................................................................................... 3
`
`Rules
`
`D. Del. LR 4.1 ............................................................................................................ 3
`
`Fed. R. Civ. P. 12 ................................................................................................... 4, 5
`
`Regulations
`
`37 C.F.R. § 1.7 ........................................................................................................... 2
`
`37 C.F.R. § 42.6 ................................................................................................... 7, 28
`
`37 C.F.R. § 42.65 ......................................................................................... 21, 22, 36
`
`vii
`
`

`
`I.
`
`Introduction
`
`
`
`This Petition is time-barred. Patent Owner sued Petitioner for infringement
`
`of U.S. Patent No. 6,750,237 in the Delaware district court in July 2014. A
`
`complaint and summons were served on Petitioner on July 25, 2014. More than a
`
`year later, on July 28, 2015, Petitioner filed the present IPR petition. Because the
`
`Petition was filed more than one year after Petitioner was served with the
`
`complaint and summons, the Petition is barred under 35 U.S.C. § 315(b), and none
`
`of the potential exceptions to § 315(b) apply.
`
`Even if the Board reaches the merits, the outcome should be the same: the
`
`Petition fails to establish a reasonable likelihood that any claim is unpatentable.
`
`Among other things, the Petition attempts to circumvent the 60-page limit by
`
`improperly incorporating by reference claim-construction positions set forth only
`
`in Dr. Gizurarson’s declaration. Even so, Dr. Gizurarson’s claim-construction
`
`positions conflict with both the intrinsic and extrinsic evidence. Moreover,
`
`Petitioner’s proposed grounds of unpatentability are based on improper hindsight
`
`and lack factual and legal support. Therefore, for the reasons detailed below, the
`
`Board should deny institution.
`
`35 U.S.C. § 315(b) Bars the Petition
`A. The Petition Was Filed More Than One Year After Petitioner
`Was Served With an Infringement Complaint
`
`AstraZeneca AB (Patent Owner) and Impax Laboratories, Inc. (its exclusive
`
`
`
`II.
`
`
`
`

`
`
`licensee) filed a complaint against Lannett Holdings, Inc. (Petitioner) and Lannett
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`Case No. IPR2015-01629
`Patent 6,750,237
`
`Company, Inc. for infringement of the ’237 patent on July 25, 2014. (Ex. 2001.) A
`
`complaint and summons were served on Petitioner on July 25, 2014. (Ex. 2002.)
`
`Petitioner filed the present Petition on July 28, 2015. (Paper 4.)
`
`Accordingly, because the Petition was filed more than one year after Petitioner was
`
`served with an infringement complaint, it is barred under 35 U.S.C. § 315(b). See
`
`RPX Corp. v. VirnetX Inc., IPR2014-00171, Paper 49 at 10 (PTAB June 5, 2014)
`
`(denying institution because a real party-in-interest was time-barred under
`
`§ 315(b)).
`
`The one-year date fell on a Saturday (July 25, 2015). This fact, however,
`
`does not save the Petition: it was not filed on the following Monday (July 27,
`
`2015), as required if a due date falls on a weekend or federal holiday, but was
`
`untimely filed on Tuesday, July 28, 2015. See Flir Sys., Inc. v. Canvs Corp.,
`
`IPR2014-00773, Paper 7 at 2 (PTAB Sept. 4, 2014) (under 37 C.F.R. § 1.7, a paper
`
`due on a weekend or federal holiday within the District of Columbia may be filed
`
`on the next business day).
`
`The § 315(b) statutory bar is jurisdictional. Unified Patents, Inc. v. Clouding
`
`IP, LLC, IPR2013-00586, Paper 12 at 3 (PTAB Apr. 22, 2014) (“[T]he Section
`
`315(b) bar is a jurisdictional issue that can be raised at any time.”). Accordingly,
`
`failure to comply cannot be excused. Bowles v. Russell, 551 U.S. 205, 212-15
`
`2
`
`

`
`
`(2007) (discussing “[j]urisdictional treatment of statutory time limits”); see also
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`Case No. IPR2015-01629
`Patent 6,750,237
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`Lemus v. DOJ, 571 F. App’x 952, 952-53 (Fed. Cir. 2014) (dismissing appeal filed
`
`three days late because statutory deadline was jurisdictional and not subject to
`
`equitable tolling). The language of § 315(b) does not permit any exceptions, and
`
`the Board thus lacks discretion to waive its requirements. See Baxter Int’l, Inc. v.
`
`McGaw, Inc., 149 F.3d 1321, 1334 (Fed. Cir. 1998) (“statutory requirements may
`
`not be waived”). Therefore, because Petitioner missed the § 315(b) statutory
`
`deadline for filing the Petition—even if by only one day—the Board must deny
`
`institution. See id.
`
`B. No Exception Applies to the Applicability of § 315(b)
`The Board has identified a few limited exceptions to the applicability of
`
`§ 315(b), none of which apply here.
`
`1.
`
`Service of Process Complied With the Local and Federal
`Rules
`
`Patent Owner met all the requirements of proper service of the complaint
`
`and summons. The summons for Petitioner was signed and sealed by Deputy Clerk
`
`Elizabeth Ghione in compliance with Local Rule 4.1 of the Local Rules of Civil
`
`Practice and Procedure of the U.S. District Court for the District of Delaware. (Ex.
`
`2002); D. Del. LR 4.1(a) (Ex. 2003). The complaint and summons were also
`
`properly served on CSC Entity Services, LLC, a registered agent authorized by
`
`Del. Code Ann. tit. 8, § 132 (Ex. 2004) to accept service of process on behalf of
`
`3
`
`

`
`
`Petitioner. (See Ex. 2002; Ex. 2001 at ¶ 11 and Ex. 2005 at ¶ 12 (alleging that CSC
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`Case No. IPR2015-01629
`Patent 6,750,237
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`Entity Services is Petitioner’s registered agent); 2006 at ¶ 12 (admitting that CSC
`
`Entity Services is Petitioner’s registered agent).) An affidavit from the server
`
`(Parcels Inc.) was attached to the summons as page two. (Ex. 2002.)
`
`Since there was nothing defective about the service of the complaint and
`
`summons, Petitioner understandably did not raise any objection in the case. (See
`
`Exs. 2007; 2008 (moving to dismiss only for lack of subject matter jurisdiction).)
`
`In any event, any objection that Petitioner could have raised is now waived as the
`
`time for such objection has long passed. See Fed. R. Civ. P. 12(h); Rates Tech. Inc.
`
`v. Nortel Networks Corp., 399 F.3d 1302, 1307 (Fed. Cir. 2005) (Rule 12(b)(2)-(5)
`
`defenses must be raised when the first significant defensive move is made by way
`
`of a Rule 12 motion or responsive pleading).
`
`Patent Owner Had Standing to Bring the First Action
`
`2.
`The effects of service of a complaint may be nullified if the action is
`
`jurisdictionally defective for lack of standing. Yamaha Corp. of America v. Black
`
`Hills Media, LLC, IPR2014-00766, Paper 7 at 9 (PTAB Nov. 24, 2014). In
`
`Yamaha, for example, the patent owner lacked standing because it did not own the
`
`patents when it filed the infringement complaint. Id. at 3. The Board therefore held
`
`that the complaint was not a viable federal pleading that could bar the petition
`
`under § 315(b). Id. at 9.
`
`4
`
`

`
`Here, Patent Owner AstraZeneca AB had standing to bring the infringement
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`Case No. IPR2015-01629
`Patent 6,750,237
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`
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`action because it holds legal title to the ’237 patent. (See Ex. 2009; see also Ex.
`
`2010; Pet. at 1 (acknowledging that the ’237 patent is owned by AstraZeneca
`
`AB)); see Pfizer Inc. v. Teva Pharm. USA, Inc., 803 F. Supp. 2d 409, 424 (E.D.
`
`Va. 2011) (entity holding legal title to a patent has standing to sue in its own
`
`name). The complaint was therefore a viable federal pleading.
`
`The First Infringement Action Was Not Dismissed
`
`3.
`Patent Owner filed a second action for infringement of the ’237 patent
`
`against Petitioner and Lannett Company, Inc. on July 30, 2014. (Ex. 2005.) The
`
`second complaint included one additional co-plaintiff. (Id.) Petitioner then moved
`
`to dismiss the first action under Fed. R. Civ. P. 12(b)(1) for lack of subject matter
`
`jurisdiction. (Exs. 2007; 2008.) The district court denied this motion and
`
`consolidated the two infringement actions for all purposes. (Ex. 2011 at 1, 3.)
`
`Dismissal of an action without prejudice could potentially nullify the effect
`
`of service of a complaint for purposes of § 315(b). Graves v. Principi, 294 F.3d
`
`1350, 1356 (Fed. Cir. 2002); Macauto U.S.A. v. BOS GmbH & KG, IPR2012-
`
`00004, Paper 18 at 15-16 (PTAB Jan. 24, 2013). But this potential exception does
`
`not apply here because the district court denied Petitioner’s motion to dismiss the
`
`first infringement action. (Ex. 2011 at 3.) At this time, neither the first nor the
`
`second action has been dismissed—both are consolidated for all purposes and are
`
`5
`
`

`
`
`being litigated together.1 Consequently, Petitioner cannot rely on Macauto to argue
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`Case No. IPR2015-01629
`Patent 6,750,237
`
`that it was not served with an infringement complaint in the first action.
`
`Further, consolidation of the two infringement actions did not nullify the
`
`effects of service of the first complaint. In Apple Inc. v. Rensselaer Polytechnic
`
`Inst., IPR2014-00319, Paper 12 at 7 (PTAB June 12, 2014), for example, the Board
`
`denied institution, holding that the petition was untimely under § 315(b). The
`
`patent owner had filed two complaints against the petitioner for infringement, and
`
`the petition was untimely under § 315(b) if the date of service of the first complaint
`
`controlled. Id. at 4. The district court consolidated the two actions and dismissed
`
`the first action without prejudice. Id. at 3. The petitioner argued that its petition
`
`was timely because the district court’s order dismissing the first action without
`
`prejudice nullified the effects of service of the first complaint. Id. at 4. The Board
`
`disagreed, finding that the first action, although dismissed without prejudice, was
`
`continued immediately in the second action by virtue of consolidation. Id. at 6-7.
`
`Accordingly, the date of service of the first complaint controlled for determining
`
`whether the petition was barred under § 315(b). Id. at 7.
`
`
`1 The Court even noted that Petitioner declined to agree that the first action should
`
`be dismissed without prejudice to the second. (Ex. 2011 at 2-3 & n.1.)
`
`6
`
`

`
`Here, because the district court denied Petitioner’s motion to dismiss and
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`Case No. IPR2015-01629
`Patent 6,750,237
`
`
`
`consolidated the two infringement actions, the issue is even more straightforward
`
`than in Apple. (Ex. 2011 at 1, 3.) Accordingly, the date of service of the first
`
`complaint on Petitioner—July 25, 2014—controls, and the Petition filed more than
`
`a year later is barred under § 315(b). Apple Inc., IPR2014-00319, Paper 12 at 7.
`
`For these reasons, the Petition is time-barred under § 315(b). The Board
`
`should therefore deny institution.
`
`Because the Petition is time-barred, the Board should not address any other
`
`issue. If the Board considers the merits, the outcome should remain the same: the
`
`proposed grounds of unpatentability fail to establish a reasonable likelihood that
`
`any claim is unpatentable.
`
`III. Claim Construction
`A.
`Incorporates Dr. Gizurarson’s
`Petitioner
`Inappropriately
`Declaration in an Attempt to Circumvent the Page Limit
`
`Petitioner argues that certain claim terms should be given their ordinary
`
`meanings, but then fails to explain those meanings in the Petition itself. (Pet. at 8-
`
`9.) Instead, Petitioner attempts to incorporate the meanings proposed in Dr.
`
`Gizurarson’s declaration. (Id.) This violates 37 C.F.R. § 42.6(a)(3). Indeed, the
`
`Petition would exceed the 60-page limit if it included the cited paragraphs of his
`
`declaration. The Board should therefore give no weight to the meanings proposed
`
`in Dr. Gizurarson’s declaration. See Cisco Sys., Inc. v. C-Cation Techs., LLC,
`
`7
`
`

`
`
`IPR2014-00454, Paper 12 at 10 (PTAB Aug. 29, 2014) (holding that a petition’s
`
`Case No. IPR2015-01629
`Patent 6,750,237
`
`incorporation of arguments from an expert declaration served “to circumvent the
`
`page limits imposed on petitions for inter partes review, while imposing on [the
`
`Board’s] time”); Tuftco Corp. v. Card-Monroe Corp., IPR2015-00505, Paper 6 at 7
`
`n.6 (PTAB July 22, 2015) (noting that petitioner inappropriately relied on
`
`declaration testimony containing claim-construction arguments); see also Fidelity
`
`Nat’l Info. Servs., Inc. v. DataTreasury Corp., IPR2014-00489, Paper 9 at 9-10
`
`(PTAB Aug. 13, 2014) (declining to consider information presented in supporting
`
`declaration because it was not sufficiently discussed in petition).
`
`Further, as explained below, Dr. Gizurarson’s proposed meanings do not
`
`comport with the claim terms’ plain meanings, are inconsistent with the
`
`specification, and are unreasonably broad.
`
`B.
`
`The Terms “Zolmitriptan,” “Buffer,” “Buffered,” and “in a
`Buffer” Should Be Given Their Plain and Ordinary Meanings
`
`Although claim terms are given their broadest reasonable interpretation in
`
`IPR proceedings, In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278-79 (Fed.
`
`Cir. 2015), the interpretation must nonetheless be consistent with the claim
`
`language, specification, and prosecution history, Microsoft Corp. v. Proxyconn,
`
`Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015).
`
`“Zolmitriptan”
`
`1.
`The term “zolmitriptan” should be given its plain and ordinary meaning—a
`
`8
`
`

`
`
`compound having the chemical name (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-
`
`Case No. IPR2015-01629
`Patent 6,750,237
`
`indol-5-yl]methyl]-2-oxazolidinone and chemical structure
`
`.
`
`Both intrinsic and extrinsic evidence support this meaning.
`
`The ’237 patent claims are directed to pharmaceutical formulations of
`
`zolmitriptan suitable for intranasal administration and to an aqueous solution of
`
`zolmitriptan. (See, e.g., Ex. 1001 at claims 1, 9, 11, 15.) No claim refers to any
`
`other molecule.
`
`The specification defines zolmitriptan as having the chemical name “(S)-4-
`
`{{3-[2-(dimethylaminoethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone.”
`
`(Id.
`
`at
`
`1:18-20.) This definition controls, not only because it is the plain and ordinary
`
`meaning but it is also the patentee’s express definition. Jack Guttman, Inc. v.
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`Kopykake Enters., Inc., 302 F.3d 1352, 1360 (Fed. Cir. 2002) (stating that the
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`“specification acts as a dictionary when it expressly defines terms used in the
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`claims” and holding that the district court erred in overlooking this definition).
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`Moreover, zolmitriptan is known in the art as a compound having the
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`equivalent
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`chemical
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`name
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`(S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-
`
`yl]methyl]-2-oxazolidinone and same chemical structure. (E.g., Ex. 2012 at 665;
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`Ex. 2013 at 4; Ex. 2014 at 797; Ex. 2015 at 393-94.) The chemical formula for
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`Case No. IPR2015-01629
`Patent 6,750,237
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`zolmitriptan is C16H21N3O2, which represents a molecular weight of 287.36. (EX.
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`2012 at 665; Ex. 2013 at 3, 6; Ex. 2016.) This extrinsic evidence is entirely
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`consistent with the intrinsic evidence and Patent Owner’s proposed construction.
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`Dr. Gizurarson proposes that “zolmitriptan” should be construed to include
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`covalently bonded “variations” of the molecule. (Ex. 1003 at ¶ 28.) But this
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`construction conflicts with the term’s plain meaning, disregards the specification’s
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`definition, and broadens the term’s scope to encompass different, unclaimed
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`molecules.
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`A covalent bond is “a chemical bond formed between two atoms in a
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`molecule by the sharing of electrons, usually in pairs, by the bonded atoms.” (Ex.
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`2017 at 141.) Thus, covalent bonds are intramolecular bonds, and the formation of
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`a covalent bond creates a different molecule. See GlaxoSmithKline LLC v. Banner
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`Pharmacaps, Inc., No. 11-cv-00046, 2013 U.S. Dist. LEXIS 112440, at *8-9 (D.
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`Del. Aug. 9, 2013) (Ex. 2018) (explaining that a chemical reaction involves the
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`transformation of chemical identity through covalent bonds). Covalently bonded
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`“variations” of zolmitriptan are therefore not zolmitriptan, but represent different
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`molecules with different chemical names, structures, and molecular weights.
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`The ’237 patent does not suggest that the term “zolmitriptan” can encompass
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`different molecules. The specification’s mention of a citrate salt of zolmitriptan
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`describes a potential ionic interaction between zolmitriptan and citric acid in
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`Case No. IPR2015-01629
`Patent 6,750,237
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`aqueous solution, not the formation of any new covalently bonded molecule (which
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`by definition would no longer be zolmitriptan). (Ex. 1001 at 3:9-13.)
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`Dr. Gizurarson attempts to override the overwhelming intrinsic and extrinsic
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`evidence by advancing a misreading of a piece of extrinsic evidence—an
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`ambiguous depiction in the Marquess reference. Dr. Gizurarson cites Marquess to
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`show that zolmitriptan has the following structure, which includes two methyl
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`(CH3) groups:
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`(Ex. 1003 at ¶ 28; Ex. 1005 at 50.)
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`
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`He then asserts that the molecule depicted in Figure 21 of Marquess is
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`zolmitriptan. (See Ex. 1003 at ¶ 88.) Figure 21, however, does not contain two
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`methyl (CH3) groups as required by Marquess’s definition of zolmitriptan. Instead,
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`it contains one methyl (CH3) group and one CH2 group:
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`
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`(Ex. 1005 at 73.)
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`A hydrogen atom has been removed from zolmitriptan and a large structure
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`Case No. IPR2015-01629
`Patent 6,750,237
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`
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`added in its place. Thus, this new molecule is not zolmitriptan, nor does it include
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`zolmitriptan. Rather, as summarized below, it has a different name, formula,
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`structure, and molecular weight.
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`
`
`Zolmitriptan
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`Marquess Figure 21
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`(S)-N-methyl-1-(3-(2-(methyl(2-
`(2-(methyl(2-(5-((2-
`oxooxazolidin-4-yl)methyl)-1H-
`indol-3-
`yl)ethyl)amino)ethoxy)ethyl)amin
`o)ethyl)-1H-indol-5-
`yl)methanesulfonamide
`C32H44N6O5S
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`Name
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`(S)-4-[[3-[2-
`(dimethylamino)ethyl]-1H-indol-
`5-yl]methyl]-2-oxazolidinone
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`Formula
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`C16H21N3O2
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`Structure
`
`
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`Molecular
`Weight
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`(This information was obtained by recreating the molecule depicted in
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`624.80
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`287.36
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`Figure 21 of Marquess using ChemBioDraw Ultra (version 14.0.0.117) to generate
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`a corresponding name, formula, and molecular weight.)
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`Dr. Gizurarson does not address these differences in name, formula,
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`structure, or molecular weight. Moreover, Marquess’s use of
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`the
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`term
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`“zolmitriptan” under Figure 21 does not indicate that this compound is
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`zolmitriptan, but only identifies the source of one of the components (ligands) of
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`Case No. IPR2015-01629
`Patent 6,750,237
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`the new molecule described.
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`The Board should therefore reject Dr. Gizurarson’s overly broad and
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`unsupported proposed construction of “zolmitriptan” and adopt the plain and
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`ordinary meaning set forth in the specification.
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`“Buffer,” “Buffered,” and “in a Buffer”
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`2.
`The terms “buffer,” “buffered,” and “in a buffer” should be given their plain
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`and ordinary meaning—systems of (1) weak acids and their conjugate bases
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`(System 1), (2) weak bases and their conjugate acids (System 2), and (3) certain
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`acid-base pairs that can function in the manner of System 1 or 2 (System 3). (Ex.
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`1006 at 227.) Both intrinsic and extrinsic evidence support this meaning.
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`Independent claim 15 and dependent claims 3 and 4 of the ’237 patent are
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`directed to the use of a “buffer” or provide that the formulation is “buffered.” (Ex.
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`1001 at claims 3, 4, 15.) Independent claims 9 and 11 provide examples of System
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`3 buffers—pharmaceutical formulations suitable for intranasal administration,
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`which are buffered by a mixture of citric acid (weak acid) and disodium phosphate
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`(weak base). (Id. at claims 9, 11.)
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`The specification states that the disclosed intranasal formulations of
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`zolmitriptan are generally prepared as aqueous formulations that are typically
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`buffered. (Id. at 2:28-30.) It then identifies a number of suitable buffering agents
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`that are consistent with Patent Owner’s proposed construction. (Id. at 2:30-35.) In
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`Case No. IPR2015-01629
`Patent 6,750,237
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`addition, Examples 1-8 specifically describe aqueous intranasal zolmitriptan
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`formulations in a System 3 buffer of citric acid (weak acid) and disodium
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`phosphate (weak base). (See id. at Exs. 1-8.)
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`The extrinsic evidence supports Patent Owner’s complete proposed
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`construction. (Ex. 1006 at 227 (listing the same three categories of buffers as
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`proposed by Patent Owner); see Ex. 2019 at 4 (identifying mixtures of weak acids
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`and conjugate bases or weak bases and conjugate acids as buffers, as in Systems 1
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`and 2); see also Ex. 2020 at 175-76 (defining buffer as including a “solution
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`containing both a weak acid and its conjugate weak base,” as in System 1); Ex.
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`2021 at 52-53 (stating that buffer solutions “commonly consist of a mixture of a
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`weak acid and its conjugate base . . . or a weak base and its conjugate acid,” as in
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`Systems 1 and 2).) Both the intrinsic and extrinsic evidence teach that the critical
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`attribute of a buffer is the pairing of an acid and a base.
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`Dr. Gizurarson’s proposed construction of buffer seeks to ignore this critical
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`acid-base pairing attribute, and thus impermissibly broadens the term’s scope
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`beyond the plain and ordinary meaning to include single-component pH adjusting
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`agents