IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`KVK-TECH, INC.,
`
`Petitioner,
`
`v.
`
`SHIRE LLC,
`
`Patent Owner.
`____________________
`Case IPR2018-00290
`US Patent No. 8,846,100
`____________________
`
`PATENT OWNER PRELIMINARY RESPONSE
`
`PUBLIC
`
`34842570v1
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`TABLE OF CONTENTS
`
`Page
`
`LIST OF EXHIBITS ................................................................................................iv
`TABLE OF AUTHORITIES ...................................................................................vi
`I.
`Introduction ..................................................................................................... 1
`II.
`The Petition Should Be Denied Under 35 U.S.C. § 325(d) because the
`Examiner Thoroughly Considered the Same Arguments about
`Burnside and ADDERALL XR ...................................................................... 4
`III. The Shojaei ‘100 Patent – A Three Component, Three Delivery Mode
`(IR-DPR-SR) Amphetamine Dosage System ................................................. 8
`A.
`The Invention and Its Technical Background ...................................... 9
`B.
`Person of Ordinary (Not Extraordinary) Skill in the Art ................... 13
`C.
`The Shojaei Specification ................................................................... 14
`D.
`The Prosecution History – Repeated Rejections over Burnside
`Were Correctly Overcome ................................................................. 15
`Claim Construction............................................................................. 19
`1.
`“About” .................................................................................... 19
`2.
`“No Food Effect” ..................................................................... 20
`IV. Petitioner’s Prior Art..................................................................................... 20
`A.
`Burnside (EX1002) Does Not Disclose a Three-Bead/Three-
`Mode Combination ............................................................................. 21
`B. ADDERALL XR (EX1003, EX1031) Does Not Disclose a
`Three-Bead/Three-Mode Combination .............................................. 23
`The “Motivational” References Fail .................................................. 25
`1.
`Kratochvil (EX1010) States a Problem but not the
`Claimed Solution...................................................................... 25
`2. Mehta (EX1015) – No Pulses and a Different Drug ................ 25
`3. Midha (EX1018) – Triple Pulse Methylphenidate .................. 27
`4.
`Couch (EX1023) – No Extrapolation ...................................... 29
`5.
`Rudnic (EX1016) and Burnside ‘776 (EX1017) -
`Different Drugs and Different Formulations ........................... 30
`-i-
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`C.
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`TABLE OF CONTENTS
`(continued)
`
`Page
`
`V.
`
`2.
`
`2.
`
`The Board Should Deny Institution of Ground 1 Because Burnside
`Does Not Disclose the Combination of Features In Any Claim .................. 30
`A.
`Burnside Lacks the Claimed Three-Bead IR-DPR-SR
`Combination ....................................................................................... 34
`B. Dependent Claims 2-4 Are Not Anticipated (Different
`Coatings) ............................................................................................ 36
`Claims 13-18 and 31 Are Not Anticipated (Cores, Layers) ............... 37
`C.
`Claims 19-20 Are Not Anticipated (Amphetamine salts) .................. 37
`D.
`Claims 5-12 Are Not Anticipated (PK Claims) ................................. 38
`E.
`Claim 21 Is Not Anticipated (No Food Effect) .................................. 41
`F.
`VI. Claims 1-31 Are Not Obvious over Burnside or ADDERALL XR
`With Burnside (Grounds 2 and 3) ................................................................ 42
`A.
`The Board Should Deny Institution of Ground 2 Because
`Burnside Does Not Make Any Claim Obvious .................................. 46
`1.
`Burnside Does Not Suggest the Pharmaceutical
`Composition of Claim 1 ........................................................... 47
`Burnside Does Not Suggest the Features of the
`Dependent Claims .................................................................... 51
`The Board Should Deny Institution of Ground 3 Because
`ADDERALL XR and Burnside Do Not Make any Claims
`Obvious............................................................................................... 52
`1.
`The Prior Art Did Not Suggest the Claimed Combination
`and Its Success ......................................................................... 52
`No Other References Motivated Combining
`ADDERALL XR And Burnside .............................................. 56
`Claims 2-4 are not Obvious (Coatings) .............................................. 58
`Claims 5-12 are not Obvious (Pharmacokinetics) ............................. 59
`Claims 13-20 and 31 are not Obvious (Cores, Layers, Salts) ............ 62
`Claim 21 is not Obvious (No Food Effect) ........................................ 63
`Claims 22-30 are not Obvious (Dosage Amounts) ............................ 63
`-ii-
`
`
`B.
`
`C.
`D.
`E.
`F.
`G.
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`TABLE OF CONTENTS
`(continued)
`
`Page
`
`VII. Objective Evidence that the Claims Are Not Obvious ................................. 64
`VIII. CONCLUSION ............................................................................................. 67
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`LIST OF EXHIBITS
`
`2001 DECLARATION OF BERNHARDT L. TROUT, Ph.D. (with CV)
`2002 DECLARATION OF SARA ROSENBAUM, Ph.D. (with CV)
`2003 FDA Orange Book Listing for MYDAYIS® (NDA N022063)
`2004 MYDAYIS® FDA Label (06-2017)
`2005 MYDAYIS® Website Pages
`2006 Amidon, U.S. Patent No. 5,229,131
`2007 Mehta, U.S. Patent No. 5,837,284
`2008 IPR2017-00011 Decision Denying Institution (RE41, 148 (300 Patent)
`2009 Excerpts from Merck, 11th Ed
`2010 Ansel, Popovich & Allen 6th, Ch. 3-5 (1995)
`2011 Sonsalia, Remington Ch. 74, - CNS Stimulants (1995)
`2012 Robinson, Remington, Ch. 94 - Sustained Release (1995)
`2013 Porter, Remington, Ch. 93 – Coating (1995)
`2014 Franz, Remington Vol. II, Ch. 57 - Sympathomimetic Drugs (1995)
`2015 Malinowsi, Remington, Ch. 53 – Bioequivalence (2000)
`2016 Stempel, 7th Ed. - Dispensing of Medication (1971)
`2017 USP 23 NF 18 - Uniformity Sec. 905 (1955)
`2018 USP 23 NF 18 1995 - Excerpts (1955)
`2019 Patrick, Human Psychopharmacology, 12:527-546 (1997)
`2020 Spencer, Arch Gen Psych, 58:775-78 (2001 Aug)
`2021 Lehninger, Principles of Biochemistry, Excerpt (1993)
`2022 Benet, Toxicologic Pathology, 23:115-123 (1995)
`2023 Shargel, Applied Bio & Pharmacokinetics, Ch. 2 (1999)
`2024 Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Ch.1 (1991)
`2025 Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Ch.5 (1991)
`2026 Chiao, Remington, Ch. 94 – Sustained Release (1995)
`2027 Hinsvark, J. Pharmacokin. Biopharm., 1:319-328 (1973)
`2028 Benet, Transplantation Proc., 31 (Suppl 3A), 7S-9S (1999)
`2029 Winters, Basic Clinical Pharmacokinetics (1994)
`
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`
`2030 Rowland, Clinical Pharmacokinetics 2d (1989)
`2031 Mircioiu, Basic & Clinical Pharmacology & Toxicology, 96:262–264 (2005)
`2032 Booijink, Future Microbiol. 2(3), 285-295 (2007)
`2033 Fischer, Pharm. Res., 4:480-485 (1987)
`2034 Gupta and Robinson, Controlled Release Delivery (1992)
`2035 Macheras, Oral Drug Absorption, Ch. 6 - Modeling Biopharm. (2006)
`2036 Schug, European J. Pharm. Sci., 15:279-285 (2002)
`2037 Hendeles, J. Allergy Clin. Immunol., 72:7:43-751 (1986)
`2038 FDA Use & Limitations of In Vitro Testing (Excerpts)
`2039 Guidance for Industry ER Formulations IVIVC (1997)
`2040 Amidon, Mol. Pharm., 7:1361 (2010)
`2041 Khan, International Journal of Pharmaceutics 140:131-143 (1996)
`2042 Koziolek, Advanced Drug Delivery Reviews 101:75–88 (2016)
`2043 Chasseaud, Ann. Rev. Pharmacol., 14:35-46 (1974)
`2044 Greenhill, J. Am. Acad. Child Adolesc. Psychiatry, 42:1234-1241 (2003)
`2045 Swanson, Clin. Pharmacol. Therap., 66:95-305 (1999)
`2046 Spencer, Current Diagn & Treatment Psych., Ch 35 – ADHD (2008)
`2047 Decision re Institution of IPR2015-02009
`2048 Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Ch. 7 – (1991)
`2049 Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Appendix II
`Superposition (1991)
`2050 Percel, US 2003-0157173A1
`2051 Couch, WO 2004-028509A1
`2052 Shire, Q3 2017 MYDAYIS Results (Excerpts)
`2053 Brauer, J. Clin. Pharm. 16-1, 72-76 (1996)
`2054 Shire, ER and IR Utilization in Adult ADHD [CONFIDENTIAL]
`2055 Shire, MYDAYIS Performance [CONFIDENTIAL]
`2056 Auiler, Curr. Med. Res. Opin., 18:311-316 (2002)
`2057 Protective Order
`
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Al-Site Corp. v. VSI Int’l, Inc.,
`174 F.3d 1308 (Fed. Cir. 1999) .......................................................................... 13
`Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc.,
`IPR2014-00360, Paper 103 (July 22, 2015) ....................................................... 62
`In re Arkley,
`455 F.2d at 588-89 ........................................................................................ 32, 35
`Astrazeneca AB v. Apotex Corp.,
`782 F.3d 1324 (Fed. Cir. 2015) .......................................................................... 34
`Becton Dickinson v. Braun,
`IPR2017-01586 Paper 8, 26 .................................................................................. 8
`Blue Calypso, LLC v. Groupon, Inc.,
`815 F.3d 1331 (Fed. Cir. 2016) .......................................................................... 33
`Cheese Sys., Inc. v. Tetra Pak Cheese & Powder Sys.,
`725 F.3d 1341 (Fed. Cir. 2013) .......................................................................... 46
`Crocs, Inc. v. ITC,
`598 F.3d 1294 (Fed. Cir. 2010) .................................................................... 29, 61
`Cultec, Inc. v. Stormtech LLC,
`IPR2017-00777 (PTAB Aug. 22, 2017) ........................................................... 4, 5
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015) .......................................................................... 19
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) .................................................................... 58, 65
`Demaco Corp. v. F. Von Langsdorff Licensing, Ltd.,
`851 F.2d 1387 (Fed. Cir. 1988) .......................................................................... 67
`
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`
`In re Dembiczak,
`175 F.3d 994 (Fed. Cir. 1999) ...................................................................... 43, 50
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .................................................................... 29, 44
`In re Dow Chem. Co.,
`837 F.2d 469 (Fed. Cir. 1988) ...................................................................... 44, 62
`Dystar Textilfarben GmbH v. C.H. Patrick Co.,
`464 F.2d 1356 (Fed. Cir. 2006) .......................................................................... 13
`Ecolochem, Inc. v. Southern California Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) .................................................................... 31, 50
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) ............................................................................ 29
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 43
`Helifix, Ltd. v. Blok-Lok, Ltd.,
`208 F.3d 1339 (Fed. Cir. 2000) .......................................................................... 34
`Honeywell Int’l v. Mexichem Amanco Holding,
`865 F.3d 1348 (Fed. Cir. 2017) .......................................................................... 59
`Hospira, Inc. v. Genentech, Inc.,
`IPR 2017-00739 ................................................................................................ 4, 5
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .............................................................. 41, 61, 63
`Impax Labs., Inc. v. Aventis Pharm., Inc.,
`545 F.3d 1312 (Fed. Cir. 2008) .......................................................................... 36
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 44
`Intendis GmbH v. Glenmark Pharms., Inc.,
`822 F.3d 1355 (Fed. Cir. 2016) .......................................................................... 44
`
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`Intri-Plex, Inc. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83, 45-47 ....................................................................... 66
`Kayak v IBM,
`CBM2016-00075 Paper 16, 8 ............................................................................... 8
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) .............................................................. 31, 32, 35
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .................................................................... 35, 46
`Koito Manufacturing Co. v. Turn-Key-Tech, LLC,
`381 F.3d 1142 (Fed. Cir. 2004) .................................................................... 54, 55
`KSR Int’l Co., v. Teleflex, Inc.,
`550 U.S. 398 (2007) .......................................................................... 13, 35, 44, 46
`
`L.A. Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly
`& Co.,
`849 F.3d 1049 (Fed. Cir. 2017) .......................................................................... 58
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00003, Paper 7, 2 .............................................................................. 43
`Lindemann Maschinenfabrik GmbH v. American Hoist & Derrick Co.,
`730 F.2d 1452 (Fed. Cir. 1984) .................................................................... 31, 34
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .................................................................... 43, 47
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009) .......................................................................... 19
`Merial Ltd. v, Virbac,
`IPR2014-01279, Paper 13, 28 (PTAB, January 22, 2015) ................................... 5
`Millennium Pharm., Inc. v. Sandoz Inc.,
`862 F.3d 1356 (Fed. Cir. 2017) .......................................................................... 61
`Mintz v. Dietz & Watson, Inc.,
`679 F. 3d 1372 (Fed. Cir. 2012) ......................................................................... 65
`
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH,
`139 F.3d 877 (Fed. Cir. 1998) ...................................................................... 29, 62
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012) .................................................................... 38, 39
`Mylan Laboratories Ltd. v. Aventis Pharma S.A.,
`IPR2016-00712, Paper 9 (Sept. 22, 2016) .......................................................... 62
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) ........................................................ 32, 34, 35, 36
`Newell Co., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 55
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`851 F.3d 1270 (Fed. Cir. 2017) .................................................................... 32, 35
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .................................................................... 64, 65
`PAR Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .................................................................... 59, 63
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 44
`Rolls-Royce, PLC v. United Techs. Corp.,
`603 F.3d 1325 (Fed. Cir. 2010) .......................................................................... 64
`SAS Inst., Inc. v. Complementsoft, LLC,
`IPR2013-00581, Paper 15 (PTAB. Dec. 30, 2013) ............................................ 47
`In re Spada,
`911 F.2d 705 (Fed. Cir. 1990) ............................................................................ 38
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) .......................................................................... 47
`Straight Path IP Group, Inc. v. Sipnet EU S.R.O.,
`806 F.3d 1356 (Fed. Cir. 2015) .......................................................................... 19
`
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`
`Therasense, Inc. v. Becton Dickinson & Co,
`593 F.3d 1325 (Fed. Cir. 2010) ...................................................................passim
`Unified Patents, Inc. v. Berman,
`IPR2016-01571 (PTAB Dec. 14, 2016) ............................................................... 8
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .......................................................................... 44
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) ............................................................................ 19
`W.L. Gore & Assocs. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) ........................................................ 40, 43, 50, 62
`Westinghouse Air Brake Tech. Corp. v. Siemens Indus., Inc.,
`IPR2017-00582, Paper 12 (July 19, 2017) ......................................................... 51
`Statutes
`35 U.S.C. § 103 ........................................................................................................ 43
`35 U.S.C. § 311(b) ..................................................................................................... 1
`35 U.S.C § 313 ........................................................................................................... 1
`35 U.S.C. § 314(a) ............................................................................................... 1, 67
`35 U.S.C. § 325(d) ......................................................................................... 2, 4, 5, 8
`Other Authorities
`37 C.F.R. § 42.24(d) .................................................................................................. 2
`37 C.F.R. § 42.100(b) .............................................................................................. 19
`37 C.F.R. § 42.107 ..................................................................................................... 1
`37 C.F.R. § 42.108(c) ............................................................................................... 67
`37 CFR §42.1, §42.108 ............................................................................................ 43
`PTO Reg. No. 31,194 ........................................................................................... 67, 1
`
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`PTO Reg. No. 33,448 ............................................................................................... 67
`PTO Reg. No. 67,466 ............................................................................................... 67
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`
`I.
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`Introduction
`Pursuant to 35 U.S.C § 313 and 37 C.F.R. § 42.107, Shire LLC (“Shire”)
`
`hereby submits this Preliminary Response to the Petition for inter partes review
`
`(the “Petition”) of U.S. Patent No. 8,846,100 to Shojaei (“Shojaei”) filed by KVK-
`
`Tech, Inc. (“KVK” or “Petitioner”). The present IPR is co-pending with IPR2018-
`
`00293, involving U.S. Patent No. 9,173,857, a continuation of the ‘100 patent.
`
`Shojaei provides a “once-daily, long-acting oral composition [that] provides
`
`effective treatment of ADHD for patients with longer day demands (e.g., 14-16
`
`awake hours)” (EX1001, 3:46-49), using a novel and non-obvious three-bead
`
`amphetamine combination: “an immediate release [IR] component, a delayed
`
`pulsed release [DPR] component and a delayed sustained release [SR]
`
`component.” Id., claim 1, 3:53-56, 5:11-20, 18:56-21:34.
`
`Shojaei has one independent dosage system claim from which all other
`
`claims depend. Shojaei also includes claims that specify pharmacokinetics (PK
`
`claims 5-12), no food effect (food effect claim 21), and doses (dose claims 22-30).
`
`The Petition should not be granted because KVK has failed to establish a
`
`“reasonable likelihood” that it would prevail with respect to at least one challenged
`
`claim under one of its alleged Grounds. 35 U.S.C. § 314(a); 35 U.S.C. § 311(b).
`
`Those Grounds are: (1) claims 1-21 and 31 are anticipated by Burnside (EX1002);
`1
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`IPR2018-00290
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`(2) claims 1-31 are obvious in view of Burnside; and (3) claims 1-31 are obvious
`
`over ADDERALL XR® (EX1003 or EX1031) in view of Burnside.
`
`As a preliminary matter, Burnside and ADDERALL XR were thoroughly
`
`considered by the Examiner during eight years of prosecution. Grounds 1 and 2
`
`regarding Burnside are identical to arguments the Applicants overcame. Regarding
`
`Ground 3, the Examiner also cited and considered Adderall XR in connection with
`
`the Tmax, AUC, and Cmax values in claims 5-12 and with the food effect in claim
`
`21. The prosecution establishes that the Examiner was not misled and correctly
`
`understood Burnside to disclose two-bead, two-pulse pharmaceutical compositions.
`
`The Petition is cumulative of art and arguments fully considered, adds nothing
`
`new, and should be denied. 35 U.S.C. § 325(d).
`
`Moreover, each of Petitioner’s Grounds is baseless.
`
`Regarding Ground 1, Burnside does not expressly or inherently disclose
`
`Shojaei’s three-bead, three-delivery mode combination dosage system. Claim 1
`
`requires a three-bead IR-DPR-SR amphetamine combination that is entirely
`
`missing from Burnside. Petitioner furthermore points to no disclosure that
`
`necessarily or inherently provides any PK parameters of claims 5-12. Conjecture
`
`is not evidence; PK parameters and food effect are drug and dosage form specific;
`
`and Shojaei’s IR-DPR-SR amphetamine composition not in the prior art.
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`IPR2018-00290
`Patent Owner’s Preliminary Response
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`Regarding Grounds 2 and 3, Petitioner has not identified any teaching in
`
`Burnside alone, or with ADDERALL XR, that discloses or suggests a three-bead
`
`composition combining IR, DPR, and SR amphetamine beads. The Petition fails to
`
`articulate a specific motivation to combine disclosures in the references, fails to
`
`support any reasonable expectation of success, and fails to address surprising and
`
`unexpected results. On the contrary, the Petition ignores that Burnside
`
`characterized “sustained-release delivery” as “problematic” for amphetamines and
`
`“unsuitable” for drugs that share certain characteristics (such as “biological
`
`tolerance”) with amphetamines. EX1002, 1:21-2:1. Furthermore, achieving all-day
`
`(16-hour) ADHD efficacy, specific PK parameters, and no food effect were
`
`unpredictable, unexpected, and surprising.
`
`Finally, Petitioner relies on inherency to establish anticipation or
`
`obviousness of the PK and food effect claims. Again, there is no evidence that
`
`combining beads from the references necessarily produces the claimed properties.
`
`KVK ignores that different combinations and ratios of IR, DPR, and SR beads in a
`
`three-bead combination will provide different PK parameters. KVK’s focus on the
`
`drug amphetamine to claim inherency, while ignoring the dosage form, is wrong
`
`and unsupported. There is no evidence that these properties are necessarily found
`
`in Petitioner’s after-the-fact combination using Burnside’s discarded SR beads. In
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`IPR2018-00290
`Patent Owner’s Preliminary Response
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`addition to its insufficient arguments regarding claim 1, Petitioner has failed to
`
`show a reasonable likelihood that claims 5-12 and 21 are invalid.
`
`The Petition rehashes old arguments, fails to establish any viable Grounds,
`
`and should be denied.
`
`II.
`
`The Petition Should Be Denied Under 35 U.S.C. § 325(d) because the
`Examiner Thoroughly Considered the Same Arguments about Burnside
`and ADDERALL XR
`Inter partes review may be declined when a petitioner reargues the “same or
`
`substantially the same prior art or arguments previously . . . presented to the
`
`Office.” 35 U.S.C. § 325(d).
`
`The PTAB’s recently designated “Informative” precedent strongly supports
`
`denial of KVK-Tech’s Petition. See Hospira, Inc. v. Genentech, Inc., IPR 2017-
`
`00739, Paper 16, 17-19 (PTAB July 27, 2017); Cultec, Inc. v. Stormtech LLC,
`
`IPR2017-00777 (PTAB Aug. 22, 2017) (Paper 7), 11.
`
`KVK’s arguments in Grounds 1 and 2, regarding anticipation or obviousness
`
`based on Burnside, are identical to those raised and considered by the Examiner
`
`and ultimately overcome by Applicants. Regarding obviousness over the
`
`ADDERALL XR references (EX1003 and EX1031), the Petition is “based, in
`
`substantial part” on prior art and arguments that “previously were presented to the
`
`Office.” Cultec, Inc. v. Stormtech LLC, IPR2017-00777 (PTAB Aug. 22, 2017)
`
`(Paper 7), 11. The Examiner made rejections over Burnside numerous times and
`4
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`IPR2018-00290
`Patent Owner’s Preliminary Response
`
`also cited ADDERALL XR for “food, Tmax, AUC and Cmax values ….” EX1005,
`
`483, 553, 584, 667, 700; EX1001, 3:20-25; EX1005, 352, 496 (Cite No. CA);
`
`Petition, 4, n.2; EX1003; EX1031; EX2001 ¶81. Furthermore, Burnside and
`
`ADDERALL XR are cited as Background in Shojaei. EX1001, 3:20-45.
`
`The references and arguments, then and now, are the same.
`
`As in Hospira and Cultec, the Examiner carefully and thoroughly considered
`
`the same prior art and arguments raised in KVK’s Petition. The Examiner
`
`considered Burnside’s disclosure of IR and DPR beads (Examples 1-3), delayed
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`SR beads (Example 4), and a two bead IR-DPR combination. He also considered
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`ADDERALL XR, which added nothing to Burnside’s two-bead composition. Only
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`after the Examiner was satisfied with the content and structure of Applicants’
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`claims did he allow the claims to issue. EX2001, ¶83. Shire submits that the Board
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`should reach the same result as in Hospira and Cultec and should deny institution.
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`35 U.S.C. § 325(d).
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`Petitioner argues that Section 325(d) should not apply because of an
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`allegedly “misleading” reference during prosecution to Burnside’s Example 4 bead
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`as a “typical” rather than “atypical” sustained release. Petition, 14-15, 63; EX1005,
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`646. However, the Example 4 structure in Burnside and Shojaei was correctly
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`described, on the same page of Applicants’ Response. Id. See, Merial Ltd. v,
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`Virbac, IPR2014-01279, Paper 13, 28 (PTAB, January 22, 2015) (declining
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`institution where certain arguments were “erroneous” rather than “misleading”).
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`Rejections over Burnside continued for two more years. Examiners read and
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`understand references. This Examiner considered Burnside and ADDERALL XR
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`extensively and without apparent mistake. EX1005, 666-67, 688, 699-700, 703,
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`773-74; EX2001, ¶83-84.
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`KVK’s cumulative references offer nothing new. Petition, 51-54, 64.
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`Petitioner cites Kratochvil (EX1010) for disclosing “the same problem and
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`solution” identified as prior art in Shojaei. Petition, 7-8; EX1001, 3:26-45. The
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`Examiner was well informed that clinicians resorted to multiple dosing of
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`ADDERALL XR plus IR hours later, because no single amphetamine
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`administration and 16-hour solution was available. Id.
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`Petitioner cites Couch (EX1023) for teaching amphetamine formulations
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`“containing immediate and sustained release beads,” including SR beads “in the
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`same configuration as Burnside Example 4.” Petition, 53. However, the Examiner
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`considered substantially the same argument in view of Percel, Odidi, and Burnside.
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`EX1005, 666-669. Furthermore, Couch, cited as WO 2004/028509 (EX2051), was
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`singled out in an IDS. See, EX1005, 710, 722-759. A month later, the Examiner
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`mailed a Notice of Allowance with an initialed copy of the IDS. Id., 780-88.
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`Adding Mehta (EX1015), Midha (EX1018), Rudnic (EX1016), and Burnside
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`‘776 (EX1017) for “triple-bead systems” is cumulative of the Examiner’s reliance
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`on Percel and Odidi. Compare, Petition, 6-7, 54-56, 59-60 and EX1005, 697-698.
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`KVK says the Examiner’s Amendment shows he “was unaware ... that
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`SURELEASE® is pH-independent” and is ethylcellulose. Petition, 63, 25 (citing
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`EX1004, EX1034, EX1035). However, the Amendment confronted pH-dependent
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`components in outer coatings of Percel, not Burnside. EX1005, 787, 702, 770, 772-
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`73. He referred to “SURELEASE®, an ethyl cellulose compound.” EX1005, 702.
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`Applicants identified ethylcellulose as “a water insoluble polymer.” Id., 772;
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`EX2050, ¶[0026]. The specification disclosed a “low water-permeable pH-
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`insensitive polymer” for over-coating the SR bead, and exemplified
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`SURELEASE® (ethylcellulose). EX1001, 9:11-17, 13:63-14:3, 16:5-21, 20:25-44,
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`Example 4. The prosecution does not support KVK’s argument that the Examiner
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`was unaware of the pH properties of a SURELEASE polymer coating.
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`Rejections based on Burnside and ADDERALL XR were overcome because
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`neither disclosed or suggested a three-bead combination or any combination
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`incorporating an SR bead of any type, including the claimed coating structure.
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`During prosecution, Applicants furnished “detailed arguments presenting evidence
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`and technical explanations that the structures were not compatible, and would not
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`have been combined by one of skill in the art because such a combination would
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`not have operated or functioned in a manner that would have assured a reasonable
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`expectation of success.” Becton Dickinson v. Braun, IPR2017-01586 Paper 8, 26.
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`“The Board does not need to revisit [eight] years of prosecution that
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`addressed the patentability of the challenged claims over the same previously-
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`considered references and arguments ....” Kayak v IBM, CBM2016-00075 Paper
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`16, 8. “[T]he record could not be clearer that [Petitioner’s] references were
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`presented to and extensively considered by the Office.” Id. Petitioner fails to show
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`why the Board “should readjudicate substantially the same prior art and arguments
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`as those presented during prosecution and considered by the Examiner.” Unified
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`Patents, Inc. v. Berman, IPR2016-01571 (PTAB Dec. 14, 2016) (Paper 10), 12.
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`Shire respectfully submits that the Petition should be denied under 35 U.S.C.
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`§ 325(d). See also, §III(D).
`
`III. The Shojaei ‘100 Patent – A Three Component, Three Delivery Mode
`(IR-DPR-SR) Amphetamine Dosage System
`The earliest priority document of Shojaei’s “Controlled Dose Drug Delivery
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`System” is U.S. Application No. 11/383,066, filed May 12, 2006. EX1001. Claim
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`1 provides a pharmaceutical composition comprising a combination of three
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`amphetamine beads: (a) an immediate release [IR] bead; (b) a first delayed release
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`bead that provides a pulsed release [DPR]; and (c) a second delayed release bead
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`that provides a sustained release [SR]. Both delayed release beads comprise an
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`enteric coating. The second delayed release bead has a pH-independent sustained
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`release coating on the delayed release coating. Claims 2-31 depend directly or
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`indirectly from claim 1 and recite additional limitations relating to, for example,
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`pharmacokinetics, food effect, and dose.
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`An embodiment of the invention is Shire’s product MYDAYIS®, approved
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`for patients 13 years and older as a once-daily treatment for ADHD that lasts for up
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`to 16 hours. EX2003, 1-3, 6; EX2005, 2.
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`The Invention and Its Technical Background
`A.
`The three