Paper No. ____
`Date Filed: July 15, 2014
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`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. 2014-00549
`
`U.S. Patent 6,316,023
`
`PRELIMINARY RESPONSE BY
`PATENT OWNERS PURSUANT TO 37 C.F.R. § 42.107
`
`
`Date Filed: July 15, 2014
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`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. 2014-00549
`
`U.S. Patent 6,316,023
`
`PRELIMINARY RESPONSE BY
`PATENT OWNERS PURSUANT TO 37 C.F.R. § 42.107
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`VI.
`
`35 U.S.C. § 315(a) Bars Noven’s Petition.......................................................1
`
`The Board Should Deny Institution Of Noven’s Petition In
`View Of Pending Delaware District Court Litigation.....................................6
`
`The Board Should Reject Noven’s Proposed Construction Of
`The Claim Term “Comprising”.......................................................................8
`
`The Board Should Exclude Rosin, Elmalem And Ebert From
`Ground 1 Because They Are Redundant.......................................................12
`
`The Board Should Exclude Rosin And Ebert From Ground 2
`Because They Are Redundant .......................................................................15
`
`The Board Should Exclude Ebert From Ground 3 Because It Is
`Redundant......................................................................................................16
`
`VII. The Board Should Exclude Ebert From Ground 4 Because It Is
`Redundant......................................................................................................17
`
`VIII. The Board Should Deny Institution Of Ground 5 Because It Is
`Redundant Of Grounds 1-3............................................................................18
`
`IX.
`
`The Board Should Deny Institution Of Ground 6 Because It Is
`Redundant Of Ground 4 ................................................................................20
`
`X.
`
`Conclusion .....................................................................................................21
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Accord Healthcare, Inc. USA v. Eli Lilly & Co.,
`IPR2013-00356 (P.T.A.B. Oct. 1, 2013) (Paper 13).......................................5
`
`Anova Food, LLC. v. Leo Sandau,
`IPR2013-00114 (P.T.A.B. June 25, 2013) (Paper 11) ....................................6
`
`Eli Lilly and Co. v. Medtronic, Inc.,
`496 U.S. 661 (1990).........................................................................................2
`
`Fresenius USA, Inc. v. Baxter Int’l, Inc.,
`721 F.3d 1330 (Fed. Cir. 2013) .......................................................................8
`
`Illumina, Inc. v. Trustees of Columbia Univ. in the City of New York,
`IPR2012-00006 (P.T.A.B. May 10, 2013) (Paper 43) ........................... 12, 14
`
`In re Ciprofloxacin Hydrochloride Antitrust Litig.,
`544 F.3d 1323 (Fed. Cir. 2008) .......................................................................3
`
`In re Rosuvastatin Calcium Patent Litig.,
`703 F.3d 511 (Fed. Cir. 2012) .........................................................................3
`
`In re Rosuvastatin Calcium Patent Litig.,
`MDL No. 08-1949, 2008 WL 5046424 (D. Del. Nov. 24, 2008) ...................8
`
`Intelligent Bio-Sys, Inc. v. Illuminia Cambridge Ltd.,
`IPR2013-00324 (P.T.A.B. Nov. 21, 2013) (Paper 19)....................................7
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00003 (P.T.A.B. Oct. 25, 2012) (Paper 7) ............... 12, 13, 18, 20
`
`Motorola Mobility LLC v. Arnouse,
`IPR2013-00010 (P.T.A.B. Jan. 30, 2013) (Paper 20) .....................................5
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`267 F. Supp. 2d 533 (N.D. W. Va. 2003)......................................................10
`
`Power Mosfet Techs., L.L.C. v. Siemens AG,
`378 F.3d 1396 (Fed. Cir. 2004) .....................................................................11
`
`ii
`
`
`
`Spectrum Int'l, Inc. v. Sterlite Corp.,
`164 F.3d 1372 (Fed. Cir. 1998) .....................................................................11
`
`Teva Neuroscience, Inc. v. Watson Labs., Inc.,
`No. 2:10-cv-05078, 2013 WL 1595585 (D.N.J. April 12, 2013)..................10
`
`Texas Instruments Inc. v. U.S. Int'l Trade Comm'n,
`988 F.2d 1165 (Fed. Cir. 1993) .....................................................................11
`
`Statutes
`
`21 U.S.C. § 355(j) ......................................................................................................1
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV)..........................................................................2, 3
`
`21 U.S.C. § 355(j)(2)(B)(iv)(II).................................................................................2
`
`21 U.S.C. § 355(j)(5)(C)(i) ........................................................................................3
`
`35 U.S.C. § 271(e)(2).................................................................................................2
`
`35 U.S.C. § 314..........................................................................................................7
`
`35 U.S.C. § 314(d) .....................................................................................................7
`
`35 U.S.C. § 315......................................................................................................4, 6
`
`35 U.S.C. § 315(a) .......................................................................................... 1, 4, 21
`
`35 U.S.C. § 315(b) .................................................................................................4, 5
`
`Regulations
`
`37 C.F.R. § 42.107(c).................................................................................................6
`
`37 C.F.R. § 42.108(a)............................................................................ 12, 16, 17, 18
`
`iii
`
`
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG (“Patent
`
`Owners”) respectfully submit this Preliminary Response to the Petition of
`
`Noven Pharmaceuticals Inc. (“Noven”) seeking inter partes review (“IPR”)
`
`of U.S. Patent No. 6,316,023 (“‘023 patent”).
`
`I.
`
`35 U.S.C. § 315(a) Bars Noven’s Petition
`
`35 U.S.C. § 315(a) provides that “[a]n inter partes review may not be
`
`instituted if, before the date on which the petition for such a review is filed,
`
`the petitioner . . . filed a civil action challenging the validity of a claim of the
`
`patent.” Noven effectively filed a civil action challenging the validity of a
`
`claim of the ‘023 patent before the date of its petition. Its petition thus is
`
`barred by 35 U.S.C. § 315(a).
`
`Noven is seeking approval from the United States Food and Drug
`
`Administration (“FDA”) under 21 U.S.C. § 355(j) of the Hatch-Waxman Act
`
`to market a generic copy of Novartis’s Exelon® Patch rivastigmine
`
`transdermal device, which is indicated for the treatment of mild to moderate
`
`dementia associated with Alzheimer’s disease and Parkinson’s disease. On
`
`April 2, 2014, Noven filed the instant petition challenging the validity of
`
`claims 1, 2, 4, 5, 7 and 8 of the ‘023 patent. More than one year before, and
`
`prior to February 18, 2013, Noven filed with the FDA a certification
`
`1
`
`
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV certification”)
`
`challenging the validity of the ‘023 patent. On February 18, 2013, Noven
`
`sent a letter pursuant to 21 U.S.C. § 355(j)(2)(B)(iv)(II) (“Paragraph IV
`
`notice letter”) informing Patent Owners of Noven’s Paragraph IV
`
`certification and challenging the validity of claims 1, 2, 4, 5 and 7-9 of the
`
`‘023 patent, thereby forcing Patent Owners to bring a civil action to defend
`
`their ‘023 patent against Noven’s challenge.
`
`The filing of a Paragraph IV certification under the Hatch-Waxman
`
`Act constitutes a “highly artificial” act of patent infringement under 35
`
`U.S.C. § 271(e)(2). Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 678
`
`(1990). This “highly artificial” act of infringement was intended by
`
`Congress to create an artificial basis for subject matter jurisdiction and to
`
`provoke the patent owner to file a civil action—despite the absence of any
`
`infringing manufacture, sale or use—so that issues of patent validity and
`
`infringement could be adjudicated by a district court in advance of FDA
`
`approval of the Paragraph IV filer’s potentially infringing drug product. Id.
`
`Consistent with this policy, the Hatch-Waxman Act further provides that if a
`
`patent owner fails to bring suit against the Paragraph IV filer for this “highly
`
`artificial” act of infringement, the Paragraph IV filer may pursue the patent
`
`2
`
`
`
`owner for a declaratory judgment of patent invalidity—again, despite the
`
`absence of any infringing manufacture, sale or use. 21 U.S.C. §
`
`355(j)(5)(C)(i).
`
`By these provisions of the Hatch-Waxman Act, the traditional roles of
`
`patent infringement litigants are deliberately reversed: the Paragraph IV filer
`
`becomes a de facto declaratory judgment plaintiff, and the patent owner
`
`becomes a de facto declaratory judgment defendant. For this reason, the
`
`Federal Circuit on several occasions has characterized the Paragraph IV
`
`filer, rather than the patent owner, as the party who initiates the challenge to
`
`patent validity. E.g., In re Rosuvastatin Calcium Patent Litig., 703 F.3d
`
`511, 515 (Fed. Cir. 2012) (“Several generic producers initiated a challenge
`
`to the [patent-in-suit] by filing an Abbreviated New Drug Application
`
`(ANDA) accompanied by a Paragraph IV certification, 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV).” (emphasis added)); In re Ciprofloxacin
`
`Hydrochloride Antitrust Litig., 544 F.3d 1323, 1334 (Fed. Cir. 2008)
`
`(“[G]eneric manufacturers … filed Paragraph IV ANDAs and initiated
`
`challenges of the validity of the patent.” (emphasis added)) (reversed on
`
`other grounds).
`
`3
`
`
`
`Thus, although Patent Owners here undertook the formality of filing a
`
`complaint against Noven, Noven alone had the power and the discretion to
`
`initiate civil action by filing a Paragraph IV certification challenging the
`
`validity of the ‘023 patent. Noven’s April 2, 2014 petition accordingly
`
`should be barred by 35 U.S.C. § 315(a), because the filing of Noven’s
`
`Paragraph IV certification more than a year before April 2, 2014 effectively
`
`constituted the filing of a civil action.
`
`The legislative history behind 35 U.S.C. § 315 further confirms that
`
`Noven’s petition should be barred. Congress has stated that the IPR process
`
`was not intended to be used as a “tool[] for harassment” by “repeated
`
`litigation and administrative attacks,” which “would frustrate the purpose of
`
`the section as providing quick and cost effective alternatives to litigation.”
`
`Ex 2001 (H.R. Rep. No. 112-98), p. 48. Consistent with Congress’s intent,
`
`the Board has construed 35 U.S.C. § 315 broadly to prevent petitioners from
`
`harassing patent owners with repeated and dilatory attacks in both district
`
`courts and at the USPTO. St. Jude Med. v. Volcano Corp., IPR2013-00258,
`
`(P.T.A.B. Oct. 16, 2013) (Paper 29 at 3) (construing § 315(b) to bar an IPR
`
`petition filed more than one year after a counterclaim); Accord Healthcare,
`
`Inc. USA v. Eli Lilly & Co., IPR2013-00356 (P.T.A.B. Oct. 1, 2013) (Paper
`
`4
`
`
`
`13 at 3-4) (construing § 315(b) to bar a petition filed more than one year
`
`after a complaint was filed even though the patent owner had filed a
`
`complaint alleging patent infringement of the same patent less than one year
`
`earlier).1 Allowing a Paragraph IV filer such as Noven to provoke civil
`
`1
`
`The one-year grace period afforded by 35 U.S.C. § 315(b) was
`
`intended to give patent infringement defendants time to decide whether to
`
`initiate IPR against patents being asserted against them in litigation.
`
`Motorola Mobility LLC v. Arnouse, IPR2013-00010 (P.T.A.B. Jan. 30,
`
`2013) (Paper 20 at 4-5). By contrast, a Paragraph IV filer already will have
`
`analyzed the relevant patents before its Paragraph IV filing and notice letter,
`
`and thus will not need any additional time to decide whether to initiate IPR
`
`once litigation begins. This distinction further serves to illustrate the extent
`
`to which a Paragraph IV filer such as Noven constitutes a de facto plaintiff.
`
`Here, Noven could have initiated IPR against the ‘023 patent as of the date
`
`of its Paragraph IV filing. And Noven knew that its Paragraph IV filing
`
`would provoke Patent Owners to sue on the ‘023 patent, particularly in view
`
`of the fact that Patent Owners previously sued several other Paragraph IV
`
`filers on the same patent. (Petition at 1.)
`
`5
`
`
`
`action, and then to file an IPR petition well after civil action is underway,
`
`clearly would subvert the stated intent of 35 U.S.C. § 315.
`
`For these reasons, Patent Owners respectfully submit that Noven’s
`
`petition is barred by 35 U.S.C. § 315(a).
`
`II.
`
`The Board Should Deny Institution Of Noven’s Petition
`In View Of Pending Delaware District Court Litigation
`
`Currently before Judge Richard G. Andrews of the United States
`
`District Court for the District of Delaware is the matter of Novartis Pharm.
`
`Corp. v. Noven Pharm. Inc., 1:13-cv-00527-RGA (D. Del.) (“Noven suit”).
`
`The Noven suit has been pending since April 3, 2013, and involves the same
`
`parties, experts and patent validity issues as this petition. Judge Andrews is
`
`scheduled to try those issues on December 1-3, 2014, well before this Board
`
`will be able to decide them. Moreover, Judge Andrews already has upheld
`
`the validity of the ‘023 patent over many of the same references raised in
`
`Noven’s petition—namely Enz, the Handbook, Rosin and Elmalem—in the
`
`matter of Novartis Pharm. Corp. v. Watson Labs. Inc., 1:11-cv-01112-RGA
`
`(D. Del.) (“Watson suit”). Because district court decisions from pending
`
`litigation do not constitute “new testimony evidence” under 37 C.F.R. §
`
`42.107(c) (see, e.g., Anova Food, LLC. v. Leo Sandau, IPR2013-00114
`
`(P.T.A.B. June 25, 2013) (Paper 11 at 2-3)), Patent Owners submit herewith
`
`6
`
`
`
`as Ex 2002 a copy of Judge Andrews’s June 18, 2014 decision from the
`
`Watson suit upholding the validity of the ‘023 patent.
`
`In view of these facts, Patent Owners respectfully request that the
`
`Board exercise its discretion to deny institution of Noven’s petition.2
`
`Denying institution of the petition will serve three goals. First, it will
`
`prevent waste of this Board’s resources adjudicating issues and references
`
`2
`
`While 35 U.S.C. § 314 sets forth standards by which the Board must
`
`deny IPR, there is no corresponding statute that sets forth standards by
`
`which the Board must institute IPR. The absence of any such statute gives
`
`the Board the discretion not to institute IPR. See Intelligent Bio-Sys, Inc. v.
`
`Illuminia Cambridge Ltd., IPR2013-00324 (P.T.A.B. Nov. 21, 2013) (Paper
`
`19 at 4) (“Congress did not mandate that an inter partes review must be
`
`instituted under certain conditions. Rather, by stating that the Director—and
`
`by extension, the Board—may not institute review unless certain conditions
`
`are met, Congress made institution discretionary.” (emphasis in original)).
`
`The non-appealable nature of the Board’s institution decisions under 35
`
`U.S.C. § 314(d) further confirms the existence of this discretionary
`
`authority.
`
`7
`
`
`
`that are already before a district court judge who is familiar with them.
`
`Second, it will eliminate the risk of inconsistent decisions between the Board
`
`and the Delaware District Court concerning the validity of the challenged
`
`claims of the ‘023 patent, such as occurred in Fresenius USA, Inc. v. Baxter
`
`Int’l, Inc., 721 F.3d 1330, reh’g denied, 733 F.3d 1369 (Fed. Cir. 2013).
`
`Third, given that trial in the Noven suit is scheduled to occur on December
`
`1-3, 2014, Patent Owners believe that the Delaware District Court will be
`
`able to render its decision on both the validity and infringement of the ‘023
`
`patent ahead of the Board’s decision on validity, thereby promoting the
`
`expeditious disposition of all patent disputes between Patent Owners and
`
`Noven, as intended by the Hatch-Waxman Act. In re Rosuvastatin Calcium
`
`Patent Litig., MDL No. 08–1949, 2008 WL 5046424, at *5 (D. Del. Nov.
`
`24, 2008).
`
`III. The Board Should Reject Noven’s Proposed
`Construction Of The Claim Term “Comprising”
`
`Noven asserts that, because each of the challenged claims contains the
`
`transition “comprising” and “do not recite a degree of optical purity,” the
`
`challenged claims “do not exclude other components from the claimed
`
`composition, including ent-rivastigmine” and thus “embrace compositions
`
`containing both rivastigmine and its enantiomer, including compositions
`
`8
`
`
`
`concerning racemic RA7.” (Petition at 9.) For the following reasons,
`
`Plaintiffs respectfully submit that Noven construction of “comprising” is
`
`wrong and should be rejected.
`
`First, Noven’s characterization of the compounds known as
`
`“rivastigmine” and “RA7” is misleading and incorrect. To clarify matters:
`
`(i)
`
`“RA7” is the racemate: i.e., N-ethyl-3-{(1-dimethylamino)
`
`ethyl}-N-methyl-phenyl-carbamate HCl. (Ex. 1009 at 2.)
`
`(ii)
`
`“Rivastigmine” is the (S)-enantiomer: i.e., (S)-N-ethyl-3-{(1-
`
`dimethylamino)ethyl}-N-methyl-phenyl-carbamate.
`
`Rivastigmine, being an (S)-enantiomer, cannot be an (R)-enantiomer. And
`
`rivastigmine, being an (S)-enantiomer, cannot be a racemate. Thus, contrary
`
`to Noven’s assertions, there is no such thing as “racemic rivastigmine.”
`
`Second, it is a scientific fact that a racemate and its enantiomers are
`
`chemically distinct compounds, and that the way in which they rotate light is
`
`the signature feature that distinguishes them. An (S)-enantiomer rotates
`
`light counter-clockwise, an (R)-enantiomer rotates light clockwise, and a
`
`racemate does not rotate light at all. Each of the challenged claims of the
`
`‘023 patent is directed expressly to “(S)-N-ethyl-3-{(1-dimethylamino)
`
`ethyl}-N-methyl-phenyl-carbamate in free base or acid addition salt form”
`
`9
`
`
`
`(emphasis added). The “(S)-” prefix specifically refers to an (S)-enantiomer.
`
`Thus, while the challenged claims can encompass some amount of (R)-
`
`enantiomer, that amount cannot be equal to or greater than the amount of
`
`(S)-enantiomer; otherwise, the claimed (S)-enantiomer will be read out of
`
`the claim.
`
`Third, a claim that is directed expressly to a specific enantiomer, such
`
`as an (S)-enantiomer, cannot be construed to encompass a racemate,
`
`regardless of whether the claim recites a degree of optical purity. E.g.,
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 267 F. Supp. 2d 533, 542-
`
`43 (N.D. W. Va. 2003) (denying defendant’s summary judgment motion that
`
`patent claim reciting (S)-enantiomer was anticipated by prior art racemate
`
`despite lack of optical purity claim limitation); Teva Neuroscience, Inc. v.
`
`Watson Labs., Inc., No. 2:10-cv-05078, 2013 WL 1595585, at *5-6 (D.N.J.
`
`April 12, 2013) (rejecting proposed construction of claim expressly
`
`requiring “R(+)” enantiomer to cover compound resembling racemic
`
`mixture).
`
`Fourth, contrary to Noven’s assertions, the transition “comprising”
`
`cannot be used to add any and all unrecited elements to a claim, and also
`
`cannot be used to read out an express limitation of the claim, such as “(S)-.”
`
`10
`
`
`
`E.g., Spectrum Int’l, Inc. v. Sterlite Corp., 164 F.3d 1372, 1379-80 (Fed. Cir.
`
`1998) (rejecting argument that “comprising” permits the addition of
`
`elements from the prior art to the elements set forth in the claim to abrogate
`
`claim limitations); Power Mosfet Techs., L.L.C. v. Siemens AG, 378 F.3d
`
`1396, 1409 (Fed. Cir. 2004) (“‘Comprising,’ while permitting additional
`
`elements not required by a claim, does not remove the limitations that are
`
`present.”). See also Texas Instruments Inc. v. U.S. Int’l Trade Comm’n, 988
`
`F.2d 1165, 1171 (Fed. Cir. 1993) (rejecting construction that would “read an
`
`express limitation out of the claims”).
`
`Fifth, Rosin, which issued on August 14, 1990, discloses the racemate
`
`RA7. (Ex. 1008, col. 10, l. 23.) Rosin was cited to the USPTO during the
`
`prosecution of the application that issued as the ‘023 patent. Consistent with
`
`the above scientific and legal principles, at no time during the prosecution of
`
`that application did the USPTO examiner assert—as Noven does now—that
`
`any claim was invalid because it “encompassed” the prior art racemate RA7.
`
`For these reasons, Patent Owners respectfully request that the Board
`
`reject Noven’s proposed construction of “comprising” as including
`
`compositions containing an equal or greater amount of “ent-rivastigmine.”
`
`11
`
`
`
`IV. The Board Should Exclude Rosin, Elmalem And
`Ebert From Ground 1 Because They Are Redundant
`
`37 C.F.R. § 42.108(a) gives the Board the discretion to “authorize the
`
`review to proceed on all or some of the challenged claims and on all or some
`
`of the grounds of unpatentability asserted for each claim.” If a petitioner
`
`presents multiple grounds in a redundant manner without drawing any
`
`meaningful distinction between them, the Board properly may deny
`
`redundant grounds as contrary to “regulatory and statutory mandates” for the
`
`“just, speedy and inexpensive resolution” of USPTO proceedings. Liberty
`
`Mutual Ins. Co. v. Progressive Casualty Ins. Co., CBM2012-00003
`
`(P.T.A.B. Oct. 25, 2012) (Paper 7 at 2). Additionally, if a petitioner relies
`
`upon multiple references for the same facts, the Board properly may deny
`
`grounds in view of the redundancy of those references. Illumina, Inc. v.
`
`Trustees of Columbia Univ. in the City of New York, IPR2012-00006
`
`(P.T.A.B. May 10, 2013) (Paper 43 at 11). Rosin, Elmalem and Ebert
`
`should be excluded from Ground 1 under both rationales.
`
`First, Ground 1 alleges that claims 1 and 7 are obvious over Enz and
`
`the Handbook, “optionally in view of Rosin and/or Elmalem and/or Ebert.”
`
`(Petition at 21, emphasis added.) The fact that Ground 1 characterizes
`
`Rosin, Elmalem and Ebert as “optional” and “and/or” references by itself
`
`12
`
`
`
`warrants exclusion, as those characterizations transform what purports to be
`
`a single ground into a plurality of alternate redundant grounds (e.g., (i) Enz,
`
`the Handbook and Rosin; (ii) Enz, the Handbook and Elmalem; (iii) Enz, the
`
`Handbook and Ebert; (iv) Enz, the Handbook, Rosin and Elmalem, etc.).
`
`See Liberty Mutual Ins. Co., CBM2012-00003 (P.T.A.B. Oct. 25, 2012)
`
`(Paper 7 at 3) (denying grounds that “involve[] a plurality of prior art
`
`references applied not in combination to complement each other but as
`
`distinct and separate alternatives” ).
`
`Second, the arguments associated with Ground 1 (Petition at 21-32)
`
`fail to explain why each of the “optional” Rosin, Elmalem “and/or” Ebert
`
`references more closely satisfies the claim limitations than the combination
`
`of Enz and the Handbook.
`
`Indeed, Noven admits in Ground 1 that Rosin
`
`and Elmalem can be “[left] aside” (Petition at 24). For these additional
`
`reasons, the Board should exclude Rosin, Elmalem and Ebert from Ground
`
`1. See Liberty Mutual Ins. Co., CBM2012-00003 (P.T.A.B. Oct. 25, 2012)
`
`(Paper 7 at 3) (“the associated arguments do not explain why one reference
`
`more closely satisfies the claim limitation at issue in some respects than
`
`another reference”).
`
`13
`
`
`
`Third, Noven in Ground 1 alleges that Elmalem and Rosin identically
`
`teach that RA7 can be combined with an antioxidant and that RA7 was
`
`susceptible to oxidative degradation. (Petition at 23-24.) 3 Noven does not
`
`rely on any other alleged teaching from Elmalem or Rosin in Ground 1, and
`
`does not attempt to draw a meaningful distinction between the relied-upon
`
`alleged teachings of Elmalem and Rosin. In view of this redundancy, the
`
`Board should at least exclude either Elmalem or Rosin from Ground 1. See
`
`Illumina, Inc., IPR2012-00006 (P.T.A.B. May 10, 2013) (Paper 43 at 11)
`
`(“While it is true that the cited references are not identical, the cited
`
`references appear to have been cited for the same facts. Illumina
`
`speculates that in certain publications an element may be more clearly set
`
`forth in one publication rather than another, but has not provided a
`
`persuasive example of such a case.” (emphasis added)).
`
`3
`
`Patent Owner’s statements herein concerning Noven’s
`
`characterizations of the references shall not be construed as an admission
`
`that such characterizations are accurate, or that such characterizations
`
`constitute a proper basis for a finding of patent invalidity.
`
`14
`
`
`
`V.
`
`The Board Should Exclude Rosin And Ebert
`From Ground 2 Because They Are Redundant
`
`For the same reasons in Section IV above, the Board should exclude
`
`Rosin and Ebert from Ground 2, which alleges that claim 2 is obvious over
`
`Enz and the Handbook “and/or” Rosin “and/or” Ebert. (Petition at 32.)
`
`As with Ground 1, the “and/or” language of Ground 2 transforms
`
`what purports to be a single ground into a plurality of alternate redundant
`
`grounds. As with Ground 1, the arguments associated with Ground 2 do not
`
`explain why each of the optional Rosin “and/or” Ebert references more
`
`closely satisfies the claim limitations than the combination of Enz and the
`
`Handbook. And as with Ground 1, the alleged teachings of Rosin and Ebert
`
`relied on by Noven are redundant of the alleged teachings of the Handbook.
`
`In Ground 2, Noven alleges that “the additional matter in claim 2 is merely a
`
`list of common antioxidants,” and “[m]any of the antioxidants in claim 2 are
`
`listed in the Handbook.” (Petition at 32.) Noven then proceeds to describe
`
`Rosin and Ebert as teaching the same antioxidants that are listed in the
`
`Handbook. (Id. at 32-33, asserting that Rosin teaches ascorbic acid, while
`
`Ebert teaches BHT, BHA and tocopherol.)
`
`Because combinations involving Rosin and/or Ebert transform
`
`Ground 2 into multiple redundant grounds, and because Noven’s reliance on
`
`15
`
`
`
`Rosin and Ebert in Ground 2 is redundant of Noven’s reliance on the
`
`Handbook, Patent Owners respectfully request that the Board exclude both
`
`Rosin and Ebert from Ground 2 pursuant to 37 C.F.R. § 42.108(a).
`
`VI. The Board Should Exclude Ebert
`From Ground 3 Because It Is Redundant
`
`For the same reasons in Sections IV and V above, the Board should
`
`exclude Ebert from Ground 3, which alleges that claims 4 and 5 are obvious
`
`over Enz and the Handbook “and/or” Ebert. (Petition at 34.)
`
`As with Grounds 1 and 2, the “and/or” language of Ground 3
`
`transforms what purports to be a single ground into a plurality of alternate
`
`redundant grounds. As with Grounds 1 and 2, the arguments associated with
`
`Ground 3 do not explain why the optional “and/or” Ebert reference more
`
`closely satisfies the claim limitations than the combination of Enz and the
`
`Handbook. And as with Grounds 1 and 2, the alleged teachings of Ebert
`
`relied on by Noven are redundant of the alleged teachings of the Handbook.
`
`In Ground 3, Noven alleges that “[t]he antioxidant concentrations recited in
`
`claims 4 and 5 overlap with antioxidant concentrations taught in the prior
`
`art,” and that the Handbook teaches such allegedly overlapping
`
`concentrations. (Petition at 34.) Noven then proceeds to describe Ebert as
`
`16
`
`
`
`“[s]imilarly” teaching concentration of antioxidants that allegedly overlap
`
`the claimed antioxidant concentrations. (Id.)
`
`Because combinations involving Ebert transform Ground 3 into
`
`multiple redundant grounds, and because Noven’s reliance on Ebert in
`
`Ground 3 is redundant of Noven’s reliance on the Handbook, Patent Owners
`
`respectfully request that the Board exclude Ebert from Ground 3 pursuant to
`
`37 C.F.R. § 42.108(a).
`
`VII. The Board Should Exclude Ebert
`From Ground 4 Because It Is Redundant
`
`For the same reasons in Section IV, V and VI above, the Board should
`
`exclude Ebert from Ground 4, which alleges that claim 8 is obvious over
`
`Enz, the Handbook, and Ebert “or” Kissel. (Petition at 36.)
`
`First, the “or” language of Ground 4 transforms what purports to be a
`
`single ground into a plurality of alternate redundant grounds. Second, the
`
`arguments associated with Ground 4 do not explain why the combination of
`
`Enz, the Handbook and Ebert more closely satisfies the claim limitations
`
`than the combination of Enz, the Handbook and Kissel. Third, the alleged
`
`teachings of Ebert relied on by Noven are redundant of the alleged teachings
`
`of Kissel. In Ground 4, Noven alleges that both Ebert and Kissel teach that a
`
`release liner “was a common component of transdermal patches.” (Petition
`
`17
`
`
`
`at 37.) Noven does not rely on any other alleged teaching from Ebert or
`
`Kissel in Ground 4, and does not attempt to draw a meaningful distinction
`
`between the relied-upon alleged teachings of Ebert and Kissel.
`
`Because combinations involving Ebert transform Ground 4 into
`
`multiple redundant grounds, and because Noven’s reliance on Ebert in
`
`Ground 4 is redundant of Noven’s reliance on Kissel, Patent Owners
`
`respectfully request that the Board exclude Ebert from Ground 4 pursuant to
`
`37 C.F.R. § 42.108(a).
`
`VIII. The Board Should Deny Institution Of
`Ground 5 Because It Is Redundant Of Grounds 1-3
`
`Ground 5 alleges that claims 1, 2, 4, 5 and 7 are obvious over Enz and
`
`Sasaki. Grounds 1-3, however, already allege that claims 1, 2, 4, 5 and 7 are
`
`obvious over various combinations of Enz, the Handbook, Rosin, Elmalem
`
`and/or Ebert. Ground 5 thus constitutes a redundant “distinct and separate
`
`alternative” to Grounds 1-3. Moreover, Ground 5 fails to explain why
`
`Sasaki more closely satisfies any limitation of any challenged claim than the
`
`Handbook, Rosin, Elmalem, Ebert references from Grounds 1-3. For these
`
`reasons, Ground 5 should be denied. See Liberty Mutual Ins. Co.,
`
`CBM2012-00003 (P.T.A.B. Oct. 25, 2012) (Paper 7 at 3) (denying grounds
`
`18
`
`
`
`that “involve[] a plurality of prior art references applied not in combination
`
`to complement each other but as distinct and separate alternatives” ).
`
`Indeed, Noven’s characterizations of the alleged teachings of Sasaki
`
`are redundant of Noven’s characterizations of the alleged teachings of Ebert.
`
`(And, as explained in Sections IV-VI above, Noven’s reliance upon the
`
`alleged teachings of Ebert in Grounds 1-3 in turn is redundant of Noven’s
`
`reliance on other references.) According to Noven, both Ebert and Sasaki
`
`teach transdermal devices having active ingredients with some structural
`
`similarity to rivastigmine (Petition at 25-26 for Ebert; at 40 for Sasaki); that
`
`those active ingredients are susceptible to oxidative degradation (id. at 15
`
`and 25 for Ebert; at 16 and 40 for Sasaki); that an antioxidant should be
`
`included with the active ingredient to address the oxidative degradation of
`
`the active ingredient (id. at 15, 27 and 33 for Ebert; at 16 and 40-41 for
`
`Sasaki); and that an antioxidant should be included in a transdermal device
`
`in an amount that overlaps with the amounts of antioxidant set forth in the
`
`challenged claims (id. at 15 and 34-35 for Ebert; at 16 and 43 for Sasaki).
`
`“[M]ultiple grounds, which are presented in a redundant manner by a
`
`petitioner who makes no meaningful distinction between them, are contrary
`
`to the regulatory and statutory mandates, and therefore are not all entitled to
`
`19
`
`
`
`consideration.” Liberty Mutual Ins. Co., CBM2012-00003 (P.T.A.B. Oct.
`
`25, 2012) (Paper 7 at 2). Since Ground 5, and the Sasaki reference on which
`
`it relies, are redundant of Grounds 1-3, Patent Owners respectfully request
`
`that the Board deny institution of Ground 5.
`
`IX. The Board Should Deny Institution Of
`Ground 6 Because It Is Redundant Of Ground 4
`
`Ground 6 alleges that claim 8 is obvious over Enz, Sasaki, and Ebert
`
`or Kissel. (Petition at 44.) Ground 4, however, already alleges that claim 8
`
`is obvious over Enz, the Handbook, and Ebert or Kissel. Ground 6 thus
`
`constitutes a redundant “distinct and separate alternative” to Ground 4.
`
`Moreover, the only difference between Ground 6 and Ground 4 is that
`
`Ground 6 replaces the Handbook with Sasaki. Neither Ground 6 nor Ground
`
`4 explains why Sasaki more closely satisfies any limitation of any
`
`challenged claim than the Handbook. And, as explained in Section VIII
`
`above, Noven’s characterizations of the alleged teachings of Sasaki are
`
`redundant of Noven’s characterizations of the alleged teachings of Ebert,
`
`which in turn are redundant of Noven’s characterization of other references.
`
`For these reasons, Ground 6 should be denied. See Liberty Mutual Ins. Co.,
`
`CBM2012-00003 (P.T.A.B. Oct. 25, 2012) (Paper 7 at 3) (denying grounds
`
`20
`
`
`
`that “involve[] a plurality of prior art references applied not in combination
`
`to complement each other but as distinct and separate alternatives”).
`
`X.
`
`Conclusion
`
`Noven’s petition is barred under 35 U.S.C. § 315(a) because Noven
`
`filed a Paragraph IV certification challenging the validity of the ‘023 patent
`
`more than one year before the April 2, 2014 date of its petition. Noven’s
`
`petition also is duplicative of its challenges
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