Paper No. ___
`Filed October 27, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MONOSOL RX, LLC
`Petitioner
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`v.
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`ARIUS TWO, INC.
`Patent Owner
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`
`
`Case No. IPR2014-00376
`Patent No. 7,579,019
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`PATENT OWNER’S RESPONSE
`UNDER 37 CFR § 42.120 TO A PETITION FOR
`INTER PARTES REVIEW OF US PATENT NO. 7,579,019
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`ME1 19118322v.2
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`Page 1
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`RB Ex. 2043
`BDSI v. RB PHARMACEUTICALS LTD
`IPR2014-00325
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`

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`Attorney Docket No. 117744-00045
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`TABLE OF CONTENTS
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`Page
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`Patent No. 7,579,019
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`TABLE OF AUTHORITIES ................................................................................... iii
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II.
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`TAPOLSKY’S INNOVATION OVER THE PRIOR ART ............................ 5
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`III. SKILL IN THE ART ....................................................................................... 8
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`IV. CLAIM CONSTRUCTION ............................................................................ 9
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`V.
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`THIS INTER PARTES REVIEW IS LIMITED TO THREE SPECIFIC
`GROUNDS .................................................................................................... 19
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`VI. LEGAL STANDARDS: MONOSOL HAS THE BURDEN TO
`PROVE ANTICIPATION AND OBVIOUSNESS ...................................... 21
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`A. MonoSol’s Burden of Proof ................................................................ 21
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`B. MonoSol’s Burden to Prove Anticipation ........................................... 22
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`C. MonoSol May Not Meet Its Burden to Prove Obviousness by
`Relying on Conclusory Statements or Conjecture .............................. 23
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`VII. THE BOARD SHOULD DISREGARD DR. PEPPAS’S
`TESTIMONY ................................................................................................ 25
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`VIII. BABAIAN FAILS TO ANTICIPATE TAPOLSKY CLAIMS 1–5
`AND 7 ............................................................................................................ 29
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`A.
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`B.
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`Babaian’s Film Is Brittle, Not Flexible ............................................... 30
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`Babaian’s Prolonged Residence Time Is More Than 1 Hour ............. 32
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`IX. ONE OF ORDINARY SKILL WOULD NOT COMBINE KEITH
`AND BABAIAN, AND THE COMBINATION WOULD NOT
`PERMIT DIRECTIONAL DELIVERY IN ANY EVENT .......................... 37
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`X.
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`FLOCKHART FAILS TO DISCLOSE THE METHODS OF
`CLAIMS 1–3 AND 5–7 ................................................................................ 43
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`Patent No. 7,579,019
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`Attorney Docket No. 117744-00045
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`A.
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`B.
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`C.
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`Flockhart Does Not Disclose a Flexible Device ................................. 43
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`Flockhart Does Not Directionally Deliver the Pharmaceutical .......... 46
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`Flockhart Does Not Show Fast Onset/Desired Level ......................... 46
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`XI. CONCLUSION .............................................................................................. 50
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`Attorney Docket No. 117744-00045
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Patent No. 7,579,019
`
`
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`
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`FEDERAL CASES
`
`Arkie Lures, Inc. v. Gene Larew Tackle, Inc.,
`119 F.3d 953 (Fed. Cir. 1997) ............................................................................ 28
`
`Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,
`776 F.2d 281 (Fed. Cir. 1985) ............................................................................ 27
`
`Atofina v. Great Lakes Chem. Corp.,
`441 F.3d 991 (Fed. Cir. 2006) ............................................................................ 35
`
`Continental Can Co. USA, Inc. v. Monsanto Co.,
`948 F.2d 1264 (Fed. Cir. 1991) .......................................................................... 30
`
`Depuy Spine, Inc. v. Medtronic Sofamor Dankek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .................................................................... 25, 40
`
`Glaxo Group Ltd. v. Apotex, Inc.,
`376 F.3d 1339 (Fed. Cir. 2004) .......................................................................... 22
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 23
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) .................................................................... 25, 40
`
`Innova/Pure Water, Inc. v Safari Water Filtration Sys.,
`381 F.3d 1111 (Fed. Cir. 2004) .......................................................................... 16
`
`InTouch Techs., Inc. v. VGo Comm’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .............................................................. 24, 26, 28
`
`K/S HIMPP v. Hear-Wear Techs., LLC,
`751 F.3d 1362 (Fed. Cir. 2014) .......................................................................... 38
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................ 24
`
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`Page 4
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`

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`Patent No. 7,579,019
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`Attorney Docket No. 117744-00045
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`Key Mfg. Group, Inc. v. Microdot, Inc.,
`925 F.2d 1444 (Fed. Cir. 1991) .......................................................................... 17
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ................................................................................ 23, 24, 40
`
`NetMoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .................................................................... 22, 35
`
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) .......................................................................... 10
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 10
`
`Richardson v. Suzuki Motor Co.,
`868 F.2d 1226 (Fed. Cir. 1989) .......................................................................... 22
`
`Rohm & Haas Co. v. Brotech Corp.,
`127 F.3d 1089 (Fed. Cir. 1997) .......................................................................... 29
`
`In re Suitco Surface, Inc.,
`603 F.3d 1255 (Fed. Cir. 2010) .......................................................................... 10
`
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 628 (Fed. Cir. 1987) ............................................................................ 22
`
`W.L. Gore & Assoc., Inc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) .......................................................................... 36
`
`In re Wilson,
`424 F.2d 1382 (CCPA 1970) .............................................................................. 17
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`FEDERAL STATUTES
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`35 USC § 102 ..................................................................................................... 19, 20
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`35 USC § 103 ........................................................................................................... 20
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`35 USC § 316(e) ...................................................................................................... 21
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`REGULATIONS
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`37 C.F.R. § 42.20(c) ................................................................................................. 21
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`Patent No. 7,579,019
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`37 C.F.R § 42.22(a) .................................................................................................. 22
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`37 C.F.R. § 42.65(a) ........................................................................................... 26, 29
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`37 CFR § 42.23(a) .................................................................................................... 21
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`37 CFR § 42.100(b) ................................................................................................... 9
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`37 C.F.R, § 42.104(b)(4) .......................................................................................... 22
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`37 CFR § 42.120 ...................................................................................................... 20
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`OTHER AUTHORITIES
`
`Ex parte Ballard,
`Decision on Appeal, Appeal 2010-003148, 2012 WL 2786407 (BPAI,
`June. 29, 2012) .................................................................................................... 47
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`Baxter Healthcare Corp. v. Millenium Biologix, Inc.,
`IRP2013-00582 and IRP2013-00590, Order (Paper No. 32), at 5 (PTAB
`Oct. 13, 2014) ..................................................................................................... 32
`
`Dominion Dealer Solutions, LLC v. AutoAlert, Inc.,
`Case IPR2013-00223, Decision on Institution of Inter Partes Review
`(Paper No. 9), at 19 (PTAB Aug. 15, 2013) ....................................................... 27
`
`Ex parte Famolari,
`Appeal No. 2010-012068, 2013 WL 958326 (PTAB, March 11, 2013) ............ 22
`
`Ex parte Gleich,
`Appeal No. 2011-006617, 2013 WL 1289418, at *3 (PTAB, Mar. 26,
`2013) ................................................................................................................... 10
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`Federal Register vol. 77, Number 157 (Tuesday, August 14, 2012), Rules
`and Regulations, pp. 48611............................................................................. 9, 29
`
`Gracenote Inc. v. Iceberg Indust. LLC, IPR2013-00551, Paper 6, Decision
`Denying Institution of Inter Partes Review, at 31 (PTAB Feb. 28, 2014) ........ 39
`
`IGB Automotive Ltd. v. Gentherm GmbH,
`Case IPR2014-00663, Decision Institution of Inter Partes Review (Paper
`No. 8) at 12 (PTAB Sept. 26, 2014) ................................................................... 29
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`Ex parte Kurth,
`Decision on Appeal, Appeal No. 93-40005, 1998 WL 1736237 (BPAI,
`Jan. 7, 1998) ........................................................................................................ 47
`
`Ex parte Levy,
`17 USPQ 2d 1461, 1464 (BPAI 1990) ............................................................... 23
`
`Monsanto Co. v. Pioneer Hi-Bred Int’l, Inc.,
`Case IPR2013-00023, Decision Denying Inter Partes Review (Paper 32)
`at 9 (PTAB, Apr. 11, 2013) .......................................................................... 17, 26
`
`Norman Noble, Inc. v. NUTech Ventures,
`Case IPR2013-00101, Decision Denying Inter Partes Review (Paper 14),
`at 6 (PTAB, June 20, 2013) .......................................................................... 10, 21
`
`Sony Corp. of America v. Network-1 Security Solutions, Inc.,
`IPR Case No. 2013-00092, Decision Denying Inter Partes Review (Paper
`No. 21), at 20-21 (PTAB May 24, 2013) ...................................................... 24, 39
`
`Synopsys, Inc. v. Mentor Graphics Corp., IPR2012-00041, Decision
`Denying Institution of Inter Partes Review (Paper No. 16), at 13–14,
`(PTAB Feb. 22, 2013) ......................................................................................... 24
`
`Ex parte Wolf,
`Appeal No. 2010-006028, 2012 WL 5494590 at * 3 (PTAB Nov. 9,
`2012) ................................................................................................................... 11
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`Page 7
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`Patent No. 7,579,019
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`I.
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`INTRODUCTION
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`Attorney Docket No. 117744-00045
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`
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`The innovation of the transmucosal delivery methods claimed in U.S. Patent
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`No. 7,579,019 to Tapolsky et al. (“Tapolsky” or “the ‘019 Patent”) lies in the
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`combination of the various claim limitations. None of the prior art methods and
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`devices had the combination of features recited in Tapolsky’s claims. Indeed, the
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`claimed combination was itself the reason for allowance:
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`The following is an examiner’s statement of reasons for allowance:
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`the prior art does not teach applicants’ instantly claimed method of
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`transmucosal delivery utilizing a bioerodable device with a residence
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`time of less than 1 hour or about 1 hour that directionally delivers a
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`systematic pharmaceutical within about 30 minutes, the device being
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`thin and flexible. This particular combination is an improvement over
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`the prior art which does not possess these particular characteristics.
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`Ex 1003 at 0090, Notice of Allowance and Fee(s) Due dated May 4, 2009, at page
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`3 (emphasis added).
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`Most inventions, of course, are combinations of existing elements. But what
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`makes this combination so “remarkable,” in the words of Arius’s expert, is that
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`combining the disparate requirements of thinness, flexibility, residence time,
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`adhesion, bioerosion, fast onset/desired blood level within about 30 minutes, and
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`directional delivery was, before Tapolsky, no easy feat. Ex. 2003, Declaration of
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`Edith Mathiowitz, Ph. D. (“Mathiowitz Dec.”), at ¶¶ 26–27. Forming polymeric
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`films that exhibit all of the claimed properties (thinness, flexibility, adherence,
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`residence time, directional delivery, etc.) is difficult because adjusting a polymer
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`film formulation to control, for example, residence time, may have the unintended
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`consequence of making the film brittle, which, in turn, affects directional delivery
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`and so forth. Making the film more flexible may decrease bioerosion of the
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`device. Adjusting the water content of the polymer film by even a few percent
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`may significantly affect flexibility, adhesiveness, and residence time. Each
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`ingredient and performance characteristic affects the others such that tinkering
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`with even one component may have a significant effect on the entire system. In
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`other words, the combination of ingredients and desired characteristics requires a
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`delicate balance. Id. at ¶¶ 20–27.1
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`1 Dr. Mathiowitz, a polymer chemist and a professor of Medical Science and
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`Engineering in Brown University’s Department of Molecular Pharmacology and
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`Biotechnology, is a noted expert on drug delivery systems, particularly bioadhesive
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`oral drug delivery systems. She is the inventor of numerous patents, is widely
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`published, and has many honors and distinctions in the field. Dr. Mathiowitz has
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`worked in polymer chemistry, biomaterials, and controlled drug delivery for over
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`thirty years and, as a result of her teaching, research, industry experience, and
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`MonoSol’s expert, Dr. Peppas, fails to account for these difficulties and
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`complexities. For example, in concluding that Babaian and Flockhart inherently
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`disclose “flexible” films, Dr. Peppas merely assumes that the film would be
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`flexible without explaining the scientific rationale, citing any support, or
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`conducting any experiments:
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`I would expect that an oral mucosa film, especially where it is a buccal
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`film, would be flexible or would become flexible upon application
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`and absorption of saliva or other biological fluid.
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`Ex. 1015, Declaration of Nicholas A. Peppas, Sc. D. (“Peppas Dec.”) at ¶ 47
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`(emphasis added).
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`I would expect that a a [sic] buccal patch would be flexible or would
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`become flexible upon application and absorption of saliva or other
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`biological fluid.
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`Id. at ¶ 52 (emphasis added).
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`As detailed below, such conclusory assumptions and conjectures, and others
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`like them, fail to meet MonoSol’s burden to show that the prior art anticipates or
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`renders obvious the Tapolsky claims. In contrast to Dr. Peppas’s reliance on
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`assumptions, Arius’s two experts, Dr. Mathiowitz and Dr. Lavin, rely on polymer
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`scholarship, understands how one of ordinary skill in the art would view the state
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`of the art and Tapolsky. Ex. 2003, Mathiowitz Dec. at ¶¶ 1-10 and 17-19.
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`science and statistical analysis, respectively, to show that the prior art did not
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`disclose the Tapolsky invention. For instance, based on the thermal properties of
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`the polymers disclosed in the prior art, the Babaian and Flockhart films would be
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`brittle, not flexible, as Dr. Peppas assumes. Unlike Dr. Peppas, Dr. Mathiowitz (a)
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`analyzed the glass transition and melting points of the polymers used in the film
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`matrices of Babaian and Flockhart to determine whether the devices would be
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`flexible or brittle, and (b) actually made the film disclosed in Flockhart and found
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`it to be brittle, not flexible. Ex. 2003, Mathiowitz Dec. at ¶¶ 59-66, 91-95.
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`Likewise, Dr. Lavin, a biostatistician, examined the data reported in Flockhart to
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`show that Flockhart does not disclose a method that achieves a fast onset or desired
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`level of the pharmaceutical in the blood within about 30 minutes. Ex. 2014,
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`Declaration of Philip T. Lavin (“Lavin Dec.”) at ¶¶ 9-14.
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`
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`Accordingly, based on a scientifically supported understanding of the art and
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`hence the disclosure of the three prior art references (Babaian, Flockhart, and
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`Keith), the prior art does not teach, either expressly or inherently, the combination
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`of at least the claimed (1) “flexible,” (2) “directionally delivering,” (3) “fast
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`onset/desired blood level,” and (4) “residence time” limitations. Further, given the
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`complexities of formulating and forming polymer films for systemic drug delivery,
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`one of ordinary skill would not have combined Keith and Babaian to achieve the
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`Tapolsky claims.
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`Patent No. 7,579,019
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`II. TAPOLSKY’S INNOVATION OVER THE PRIOR ART
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`Attorney Docket No. 117744-00045
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`As prefaced above, Tapolsky claims certain methods for directionally
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`delivering a systemic pharmaceutical to oral mucosal tissue by using a bioerodable
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`device composed of soluble polymers and having certain characteristics.
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`Representative Claim 1, the only independent claim, recites the following
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`limitations (with those missing from the cited prior art italicized):
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`1. A method for
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`the
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`transmucosal delivery of a systemic
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`pharmaceutical for achieving a fast onset of activity in a subject or a
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`desired level of a systemic pharmaceutical in the blood of a subject,
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`comprising:
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`adhering a bioerodable device to an oral mucosa surface of a
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`subject such that there is minimal foreign body sensation;
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`and
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`directionally
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`delivering
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`an
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`amount
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`of
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`a
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`systemic
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`pharmaceutical from the bioerodable device to mucosal
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`tissue of the subject such that an effective amount of the
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`systemic pharmaceutical is delivered to the subject achieving
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`a fast onset of activity in the subject or a desired level of the
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`systemic pharmaceutical in the blood of the subject within
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`about 30 minutes,
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`wherein the bioerodable device has a residence time of less than 1
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`hour or about 1 hour, and the device comprises a thin and flexible
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`adherent and bioerodable polymeric film containing a systemic
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`pharmaceutical, and wherein the bioerodable device comprises soluble
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`polymers selected based on dissolution rates to achieve the desired
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`residence time and release profile.
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`Ex. 1014, Tapolsky at 24:47–67 (emphasis added).
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`As seen above, the claimed bioerodable device is both “thin and flexible”
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`and comprises an “adherent and bioerodable polymeric film” composed of “soluble
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`polymers” selected for desired performance characteristics. The device has a
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`defined “residence time” on the mucosal tissue surface (in Claim 1, “less than 1
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`hour or about 1 hour” or, in Claim 3, “less than 30 minutes or about 30 minutes”)
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`and causes “minimal foreign body sensation.” The claimed method “directionally
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`deliver[s]” an “effective amount” of the systemic pharmaceutical and achieves,
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`“within about 30 minutes,” either “a fast onset of activity” or a “desired level” of
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`the pharmaceutical in the blood of the subject.
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`The claimed methods solve a number of problems in the prior art. For
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`instance, in the prior art, the residence time of the pharmaceutical carrier was either
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`too short or too long. When the residence time was too short, the pharmaceutical
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`carrier would be washed away from the treatment site before the pharmaceutical
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`agent or the carrier itself could have its desired effect, whether in delivering an
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`effective amount or desired level of the drug to the patient or in acting as a wound
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`protectant. See Ex. 1014, Tapolsky at 1:27–33 (“Given the tendency of natural
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`bodily fluids to rapidly wash away topically applied pharmaceutical components,
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`the topical treatment of wet mucosal tissues has been problematic. In the mouth,
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`saliva, natural replacement of the mucosal tissue, as well as, eating, drinking, and
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`speaking movements are some of the problems that have limited the effectiveness
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`and residence time of pharmaceutical carriers.”); 1:57–59 (“[T]his type of
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`pharmaceutical carrier [a bioadhesive gel] has a very limited residence time . . . .”);
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`and 2:7–15 (“Pastes have also been used as film protectants and as drug delivery
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`systems [but have] a limited residence time.”).
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`
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`On the other hand, other devices had excessively long residence times
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`because, for example, they were not bioerodable. For example, many of the prior
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`art film systems for drug delivery to mucosal surfaces were composed of water-
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`insoluble polymers (see Tapolsky at 2:43–48) and thus did not provide “a water
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`erodible device with good adhesive properties.” Id. at 3:32–33. These devices
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`were bulky and caused unpleasant and prolonged foreign body sensations. Further,
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`because they did not erode, they had to be “peeled off the site of application,” thus
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`removing tissue and causing pain. Id. at 3:27–37; see also 2:19–23 (“Although
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`residence time is improved with the use of bioadhesive tablets, they are not user
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`friendly, especially when used in the oral cavity, given the unpleasant feelings
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`associated with their solidity, bulkiness, and slow erosion time”).
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`The prior art relied upon in instituting this proceeding—Babaian, Flockhart,
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`and Keith—also suffers from many shortcomings. As will be detailed in Sections
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`VIII–X below, these references fail to teach one or more of the claim limitations,
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`including the “flexible,” “residence time,” “directional delivery,” and “fast
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`onset/desired level” limitations. In particular, the prior art does not teach the
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`claimed combination.
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`
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`The bioerodable devices used in the methods of Claims 1–7, however, are
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`just right: they solve the residence time problem, directionally deliver the
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`pharmaceutical, and are flexible. In addition, the claimed methods allow for
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`controlled adjustment of residence time of about one hour or less by using an
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`appropriate formulation of water-soluble polymers of different molecular weights
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`or different chemical compositions. Ex. 1014, Tapolsky at 6:5–40. The claimed
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`methods also provide many other features and advantages not found in the prior
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`art. See, e.g., id. at 5:13–6:40 (cataloging some of the advantages over the prior
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`art).
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`III. SKILL IN THE ART
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`
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`The relevant field of art here is the design, development, and use of
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`bioerodable polymeric devices for delivery of pharmaceuticals to mucosal tissue.
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`Attorney Docket No. 117744-00045
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`Ex. 2003, Mathiowitz Dec. at ¶ 17; see also Ex. 1014, Tapolsky at Abstract and at
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`1:15–20 (Field of Invention). The relevant time frame is before October 1995. Id.
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`at ¶ 19. A person of ordinary skill in the art at that time would have at least an
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`undergraduate degree in physical polymer science or chemical engineering and
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`several years practical experience designing and developing bioerodable polymeric
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`devices for drug delivery. In particular, one of ordinary skill would understand the
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`thermal properties of polymers. Id. at ¶ 18. As prefaced above, Dr. Mathiowitz is
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`qualified to express the views of the hypothetical person of ordinary skill in the art
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`due to her years of experience teaching and researching in the field, her industry
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`experience, her conversations with others working in the field, and her extensive
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`review of the relevant technical literature over the years. Id. at ¶ 19.
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`IV. CLAIM CONSTRUCTION
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`Claims in an unexpired patent are interpreted using the broadest reasonable
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`construction. See 37 CFR § 42.100(b); see also Office Patent Trial Practice Guide,
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`77 Fed. Reg. 48756, 48766 (Aug. 14, 2012). The broadest reasonable construction,
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`however, must still be consistent with the patent specification as interpreted by one
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`of ordinary skill in the art. Ex parte Gleich, Appeal No. 2011-006617, 2013 WL
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`1289418, at *3 (PTAB, Mar. 26, 2013) (stating that claims must be read “in light
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`of the specification as it would be interpreted by one of ordinary skill in the art”);
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`see also In re NTP, Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011) (“While the Board
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`must give the terms their broadest reasonable construction, the construction cannot
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`be divorced from the specification and the record evidence.”); In re Suitco
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`Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010) (“[T]his court has instructed
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`that any such construction be ‘consistent with the specification . . . and that claim
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`language should be read in light of the specification as it would be interpreted by
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`one of ordinary skill in the art.’”( quoting In re Bond, 910 F.2d 831, 833
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`(Fed.Cir.1990)).
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`Often, the ordinary meaning of a claim term to one of ordinary skill will be
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`immediately apparent and could even be the term’s common English meaning.
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). “In
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`other cases, however, the meaning of a claim term is not immediately apparent
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`from the intrinsic record alone, and construction in those cases is aided by extrinsic
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`evidence concerning relevant scientific principles, the meaning of technical terms,
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`and the state of the art.” Norman Noble, Inc. v. NUTech Ventures, Case IPR2013-
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`00101, Decision Denying Inter Partes Review (Paper 14), at 6 (PTAB, June 20,
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`2013); see also MPEP 2111.01(I) and (III) (noting that the meaning of a term may
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`be evidenced by a variety of sources, including “the words of the claims
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`themselves, the remainder of the specification, the prosecution history, and
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`extrinsic evidence concerning relevant scientific principles, the meaning of
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`technical terms, and the state of the art”).
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`While the claims must be read in light of the specification, it is inappropriate
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`to read claim limitations out of the claims entirely. See Ex parte Wolf, Appeal No.
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`2010-006028, 2012 WL 5494590 at * 3 (PTAB Nov. 9, 2012) (“The broadest-
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`construction rubric does not give the Examiner a license to ignore or misinterpret
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`claim terms . . . .”). In this case, MonoSol and its expert, Dr. Peppas, have, in
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`effect, asked the Board to read out or ignore claim terms (such as the word
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`“flexible”), thus undermining their anticipation and obviousness arguments.
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`Arius agrees with the Board’s interpretation of “achieving a fast onset of
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`activity in the subject or a desired level of the systemic pharmaceutical in the blood
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`within about 30 minutes.” Arius, however, respectfully contends that other claim
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`terms not previously construed by the Board are relevant to the dispute because,
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`inter alia, they have been read out of the claim. These terms include (1)
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`“bioerodable,” (2) “directionally delivering,” and (3) “thin and flexible.” The
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`proposed constructions of these terms are discussed below.
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`1. “bioerodable”
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`As prefaced above, the recited components and features of the claimed
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`methods affect one another in dynamic and sometimes unpredictable ways.
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`Residence time may affect flexibility, which in turn may affect directional
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`delivery, and so forth. Ex. 2003, Mathiowitz Dec. at ¶¶ 22–24. In this case, an
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`understanding of “bioerodable” will help show why the Keith and Flockhart
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`references do not teach methods for “directionally delivering” the systemic
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`pharmaceutical.
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`To one of ordinary skill in the art, the term “bioerodable” in the context of
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`Tapolsky means that the bioerodable device (e.g., a polymer film) dissolves in the
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`presence of bodily fluids. Ex. 2003, Mathiowitz Dec. at ¶ 28. In the specification,
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`the term “bioerodable” is equated with the term “water-erodable” and, more
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`particularly, with the concept of solubility caused by water or bodily fluids. Id.
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`(citing Tapolsky at 4:47–50, 4:62–64, and 5:58–61). Indeed, the specification
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`distinguishes prior art films that were water insoluble from the prior art water
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`soluble films. Ex. 1014, Tapolsky at 5:58–61 (“[U]nlike the film systems known
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`in the art which are used to deliver pharmaceutical through the skin or mucous, the
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`device of the present invention is made of water-erodable components and thus is
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`bioerodable.”) (emphasis added) .
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`To one of ordinary skill, bioerosion involves, for example, dissolution. But
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`bioerosion does not involve melting. Ex. 2003, Mathiowitz Dec. at ¶ 29.2 The
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`Tapolsky specification never mentions melting of the bioerodable device but,
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`instead, consistently equates bioerosion with water solubility and hence dissolution
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`2 Melting is a phase change caused by temperature while dissolution is caused by
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`the presence of a solvent (e.g., water or bodily fluids). Ex. 2003, Mathiowitz Dec.
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`at ¶ 29.
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`or erosion caused by bodily fluids. Id. (citing Ex. 1014, Taposky at 3:25–40, 3:44–
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`54, 5:33–38, and 5:61–67). As discussed with respect to “directionally delivering”
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`below, a device that melts or mostly melts, rather than bioerodes (e.g., dissolves in
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`the presence of water or bodily fluids), will not directionally deliver the
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`pharmaceutical to the mucosa.
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`2. “directionally delivering”
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`To one of ordinary skill, the term “directionally delivering” means “mainly
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`or preferentially delivering.” Ex. 2003, Mathiowitz Dec. at ¶ 30 (citing Ex. 1014,
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`Tapolsky at 11:49–60). MonoSol’s proposed construction is not significantly
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`different, except that it unnecessarily adds in the words “toward the mucosa.” See
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`Ex. 1015, Peppas Dec. at ¶ 17. These words are unnecessary because Tapolsky’s
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`Claim 1 already recites “directionally delivering an amount of a systemic
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`pharmaceutical from the bioerodable device to mucosal tissue.” Ex. 1014,
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`Tapolsky at 24:54–55 (emphasis added). In other words, the Tapolsky claims
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`already include the prepositions relating to the direction of movement, and thus,
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`adding “toward the mucosa” is superfluous.
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`MonoSol concedes that Keith (Ex. 1011, U.S. Patent Number 4,764,378)
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`does not disclose directional delivery. Petition at 34. The reason that the Keith
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`device fails to directionally deliver is that the device melts or mostly melts rather
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`than bioerodes. As Dr. Mathiowitz explains, not every thin film device applied to
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`mucosal tissue will directionally deliver. Rather, directional delivery depends on
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`several factors, such as proper adherence to the mucosal tissue, a suitable soluble
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`polymer film composition and configuration, and other factors. Ex. 2003,
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`Mathiowitz Dec. at ¶¶ 32–34, 40. In particular, if the device melts rather than
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`bioerodes, directional delivery becomes far more difficult. A melting film flows
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`out and away from the original pre-melt adhesion site. Accordingly, the
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`concentration of components in the device significantly changes, and the
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`pharmaceutical active contained in the melting device flows into the oral cavity
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`and over a wide and uncontrolled area of the mouth. Ex. 200