`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________________________
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`MERCK SERONO SA,
`Patent Owner.
`_________________________________________________
`Case IPR2023-00050
`Patent 8,377,903
`____________________________________________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`IPR2023-00050
`U.S. Patent No. 8,377,903
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`TABLE OF CONTENTS
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`Page
`Introduction ...................................................................................................... 1
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`Background ...................................................................................................... 5
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`I.
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`II.
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`III.
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`Person Of Ordinary Skill In The Art ............................................................... 7
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`IV. Claim Construction .......................................................................................... 7
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`V.
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`The Petition Should Be Denied Under 35 U.S.C. § 325(d) ............................. 8
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`A.
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`The Office Already Considered Petitioner’s Alleged Prior Art And
`Arguments ........................................................................................... 10
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`1.
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`2.
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`Becton Dickinson Factors (a) And (b): Asserted Art Was
`Considered During Examination............................................... 10
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`Becton Dickinson Factor (d): Petitioner’s And The Examiner’s
`Arguments Are Not Materially Different ................................. 11
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`B.
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`Petitioner Has Not Identified A Material Error By The Examiner ..... 13
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`1.
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`2.
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`3.
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`Becton Dickinson Factor (c): Asserted Art Was Evaluated
`During Examination .................................................................. 14
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`Becton Dickinson Factor (e): Petitioner Has Not Identified Any
`Examiner Error .......................................................................... 15
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`Becton Dickinson Factor (f): Additional Evidence Does Not
`Warrant Reconsideration .......................................................... 20
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`VI. Petitioner Is Not Reasonably Likely To Prevail On Any Ground ................. 21
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`A. Ground I – Bodor Does Not Anticipate .............................................. 21
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`i
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`1.
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`2.
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`Ground I Is Based On An Incorrect Interpretation Of The Law
` ................................................................................................... 21
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`Bodor Does Not Disclose All Claim Limitations Expressly,
`Inherently, Or By Inference ...................................................... 25
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`a)
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`b)
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`c)
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`Bodor Does Not Disclose RRMS or early SPMS .......... 25
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`Bodor Does Not Disclose Induction Period Dose Of
`About 1.7 Or 1.7-3.5 Mg/Kg Or Maintenance Period
`Dose Of About 1.7 Mg/Kg ............................................. 27
`
`Bodor Does Not Disclose The Claimed Maintenance
`Period Or “Cladribine-Free Period” Thereafter ............. 32
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`B.
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`Ground II – The Challenged Claims Are Not Obvious Over Bodor .. 41
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`1.
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`2.
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`3.
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`Bodor Does Not Disclose Or Suggest All Claim Limitations .. 41
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`Petitioner Has Not Established Any Motivation To Modify
`Bodor’s Method to Arrive At The Challenged Claims ............. 42
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`Petitioner Has Not Established Any Reasonable Expectation Of
`Success In Modifying Bodor’s Method to Arrive At The
`Challenged Claims .................................................................... 49
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`C.
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`Ground III – The Challenged Claims Are Nonobvious Over Bodor
`And Rice .............................................................................................. 54
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`1.
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`2.
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`Bodor And Rice Fail To Disclose Or Suggest All Claim
`Limitations ................................................................................ 55
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`Petitioner Has Not Established Any Motivation To Modify
`Bodor’s Method In View Of Rice To Arrive At The Challenged
`Claims ....................................................................................... 57
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`ii
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`3.
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`Petitioner Has Not Established Any Reasonable Expectation Of
`Success In Combining Bodor With Rice To Arrive At The
`Challenged Claims .................................................................... 61
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`VII. Objective Indicia Support Non-Obviousness ................................................ 63
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`VIII. Conclusion ..................................................................................................... 63
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`iii
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`
`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Acoustic Tech., Inc. v. Itron Networked Sols., Inc.,
`949 F.3d 1366 (Fed. Cir. 2020) .......................................................................... 22
`Advanced Bionics, LLC v. Med-El Elektromedizinische Gerate GmbH,
`IPR2019-01469, Paper 6 (P.T.A.B. Feb. 13, 2020) .....................................passim
`Akamai Techs., Inc. v. Cable & Wireless Internet Servs., Inc.,
`344 F.3d 1186 (Fed. Cir. 2003) .......................................................................... 23
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (P.T.A.B. Dec. 15, 2017) ........................................... 10
`Bettcher Indus. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) ............................................................................ 22
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Pat.
`Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) .......................................................................... 49
`Dayco Products, Inc. v. Total Containment, Inc.,
`329 F.3d 1358 (Fed. Cir. 2003) .......................................................................... 30
`
`Eli Lilly & Co. v. L.A. Biomedical Rsch. Inst. at Harbor-UCLA Med.
`Ctr.,
`849 F.3d 1073 (Fed. Cir. 2017) .......................................................................... 24
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`8 F.4th 1331 (Fed. Cir. 2021) ............................................................................... 8
`Ex Parte Ramsey,
` No. 2009-3451, 2009 WL 3044465 (B.P.A.I. Sept. 22, 2009) ..................... 23, 33
`Forest Lab’ys, Inc. v. Ivax Pharms., Inc.,
`438 F. Supp. 2d 479 (D. Del. 2006) ........................................................ 26, 29, 34
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`iv
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`
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) .............................................................................. 58
`In re Jasinski,
`508 F. App’x 950 (Fed. Cir. 2013) ....................................................................... 8
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) ...................................................................passim
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`851 F.3d 1270 (Fed. Cir. 2017) .......................................................................... 26
`In re Peterson,
`315 F.3d 1325 (Fed. Cir 2003) ........................................................................... 47
`Pitney Bowes, Inc. v. Hewlett-Packard Co.
`
`182 F.3d 1298, 1305 (Fed. Cir. 1999) .................................................................. 8
`R.J. Reynolds Vapor Co. v. Fontem Holdings 1 B.V.,
`IPR2017-01642, Paper 10 (P.T.A.B. Jan. 16, 2018) .......................................... 14
`In re Robertson,
`169 F.3d 743 (Fed. Cir. 1999) ............................................................................ 24
`Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) .......................................................................... 49
`Unigene Lab’ys, Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .......................................................................... 53
`Verdegaal Bros. v. Union Oil Co. of Cal.,
`814 F.2d 628 (Fed. Cir. 1987) ...................................................................... 21, 28
`W.L. Gore & Assoc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) .......................................................................... 58
`Ziegmann v. Stephens,
`IPR2015-01860, Paper 13 (P.T.A.B. Sept. 6, 2017) ..................................... 14, 15
`Federal Statutes
`35 U.S.C. § 314(a) ................................................................................................... 21
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`35 U.S.C. § 325(d) ........................................................................................... 2, 8, 21
`35 U.S.C. § 325(d) cesccessccsssssecsecessssssesecssssssesscssrsssessscensusessccessuuseceesssnseeseesnseees 2, 8, 21
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`INTRODUCTION
`The Board should not institute inter partes review of claims 17, 19–20, and
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`IPR2023-00050
`U.S. Patent No. 8,377,903
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`I.
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`22–29 of U.S. Patent No. 8,377,903 (“challenged claims”) because Petitioner fails
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`to show any reasonable likelihood of prevailing.
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`Before the ’903 patent’s invention, numerous multiple sclerosis (“MS”)
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`clinical trials concluded that high doses equivalent to at least 5.0 mg/kg oral
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`cladribine (i.e., intravenous or subcutaneous doses of 2.1, 2.8, or 3.65 mg/kg, per
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`Petitioner’s bioavailability calculation) were “not found to be effective against MS
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`clinical deterioration.” See Ex. 1026, 41; Ex. 1018, 7 (Table III). Further, there
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`were significant long-term safety concerns about using cladribine to treat MS,
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`including increased cancer risk, hematologic toxicity, and bone marrow
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`suppression. Ex. 1002, 2:59-3:2, 3:22-30; Ex. 1016, 5-6; Ex. 1027, 5; Ex. 1018,
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`12. The ’903 patent claims a dosing regimen for treating relapsing-remitting
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`multiple sclerosis (“RRMS”) or early secondary progressive multiple sclerosis
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`(“SPMS”) based on the inventors’ surprising discovery of a specific combination
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`of (a) low oral cladribine weight-based dose, (b) dosing periods, and (c) drug-free
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`periods. The claimed method overcame the challenges of the cladribine clinical
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`1 Hereinafter, all emphasis is added unless otherwise noted.
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`studies and provides a safe and effective method for treating RRMS or early
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`SPMS, now approved by the FDA in Mavenclad®.
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`The present petition is a poorly conceived challenge that merely repackages
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`the same art and arguments evaluated and overcome during prosecution. The
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`Petition should be denied for at least the following reasons.
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`First, every Becton Dickinson and Advanced Bionics factor favors denial
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`under 35 U.S.C. § 325(d). Bodor (Ex. 1029), the key reference on which all
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`grounds rely, and Rice (Ex. 1008), the secondary reference, were before the Office,
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`and the Examiner extensively evaluated Bodor’s counterpart with the same
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`specification (Ex. 1007). Thus, the subject matter of all references used in the
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`Petition’s Grounds was already considered by the Office during examination, and
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`Petitioner’s arguments based on Bodor were already overcome by Patent Owner
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`(“PO”) during prosecution. Additionally, Petitioner fails to establish any error by
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`the Examiner in law or in claim construction. The prosecution history reflects the
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`Examiner’s understanding of both the law and the scope of the challenged claims
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`as the Examiner specifically discussed the dependent claims reciting the same dose
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`for the induction and maintenance periods. Petitioner merely disagrees with the
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`Examiner’s allowance of the challenged claims. This is not enough to warrant
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`institution under Advanced Bionics.
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`Second, Ground I must fail because Petitioner misses several threshold
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`requirements to show anticipation. Petitioner fails to show that Bodor teaches,
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`expressly or inherently, every element of the challenged claims, such as treating
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`RRMS or early SPMS, the weight-based dosage, and the maintenance period.
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`Faced with these missing limitations, Petitioner instead relies on an incorrect
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`“reasonable inference” standard to try to show anticipation. But Petitioner
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`misapprehends the law: a person of ordinary skill in the art (“POSA”) must
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`reasonably understand or infer from a reference that a missing limitation is
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`necessarily present. Petitioner fails to meet this standard—its declarant opines that
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`“Bodor is silent on exactly what parameters would apply to the dosing regimen of
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`the maintenance phase, and instead instructs practitioners to apply whatever
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`regimen would be deemed appropriate.” Even under Petitioner’s incorrect
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`anticipation standard, Petitioner fails to show that a POSA would have reasonably
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`“inferred” the missing limitations.
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`Third, Petitioner’s obviousness challenges fare no better. Ground II—a
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`single-reference obviousness ground based on Bodor—has numerous fatal flaws,
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`including failure to demonstrate Bodor discloses or suggests all claim limitations,
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`such as treating RRMS or early SPMS, the weight-based dosage, and the
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`maintenance period, even in view of other art and common knowledge.
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`3
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`Ground II also fails because Petitioner does not establish that a POSA would
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`have been motivated to modify Bodor’s method, including using Rice’s reportedly
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`ineffective cladribine dosages in any treatment phase, to arrive at the challenged
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`claims or to have any reasonable expectation of success in doing so. Petitioner
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`fails to identify even a single example of a cladribine dosing regimen that used the
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`same dosage for two different dosing phases or used the claimed doses for
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`induction and maintenance. Indeed, the prior cladribine trials showed otherwise.
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`Further, Petitioner’s “trial and error” proposition fails to explain why a POSA
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`would have been motivated to select the specific claimed dosing method from the
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`infinite number of potential combinations of doses, dosing period length and
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`number, and drug-free period length and number, or have any reasonable
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`expectation of success in doing so, when the prior art provides no guidance
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`regarding which combination would result in a safe and effective MS treatment
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`method.
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`Ground III, adding Rice, relies on the same deficient arguments as Grounds
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`I-II. The addition of Rice, a subcutaneous cladribine study in which “clinical
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`efficacy was not shown,” does not cure the fundamental defects in Bodor,
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`including that it does not disclose using any of the claimed doses in induction and
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`maintenance periods or a maintenance period after an 8-10-month cladribine-free
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`period. Rice also provides no motivation or reasonable expectation of success in
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`arriving at the claimed induction period dose range in view of its reportedly
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`ineffective doses.
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`Accordingly, institution of inter partes review should be denied.
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`II. BACKGROUND
`MS is a chronic inflammatory demyelination disease of the central nervous
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`system. Ex. 1002, 1:26-28. Common types of MS include RRMS, SPMS, and
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`primary progressive MS (“PPMS”). Id., 1:48-50; Ex. 1012, 2-3.
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` As of December 2004, Magnetic Resonance Imaging (“MRI”) was used to
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`detect brain lesions in certain forms of MS; however, MRI findings often failed to
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`correlate with clinical findings. See Ex. 1018, 6; Ex. 1008, 9. As such, “MRI is
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`best kept for use only as a secondary end-point in controlled clinical trials.” Ex.
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`1018, 6.
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`At that time, there were six FDA-approved disease modifying treatments
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`(“DMTs”) for MS: three beta interferons (Betaseron®; Avonex®; Rebif®),
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`glatiramer acetate (Copaxone®), mitoxantrone (Novantrone®), and natalizumab
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`(Tysabri®). Ex. 1002, 2:16-21; Pet. 4. All were injectables, and none was
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`approved for oral administration. Ex. 1019, 10; Ex. 1020, 12; Ex. 1021, 3; Ex.
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`1022, 17; Ex. 1023, 17; Ex. 1017, 2.
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`Five of these FDA-approved drugs use as the recommended dose a
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`continuous, single-dosing phase at flat (i.e., not weight-based), fixed doses without
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`5
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`any extended drug-free period: Avonex®, 30 mcg once weekly; Betaseron®, 0.25
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`mg every other day; Copaxone®, 20 mg daily; Rebif®, 44 mcg three times weekly;
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`Tysabri®, 300 mg once every four weeks. Ex. 1019, 10; Ex. 1020, 12; Ex. 1021, 3;
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`Ex. 1022, 17; Ex. 1023, 17. Novantrone® is administered 12 mg/m2 intravenously
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`every 3 months. Ex. 1017, 30. Thus, a POSA would have understood that as of
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`December 2004, the recommended dosing of most FDA-approved MS drugs was a
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`continuous, single-dosing phase without any extended drug-free period and that
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`none of these drugs had weight-based dosing.
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`As of December 2004, numerous MS clinical trials studying cladribine used
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`a single, high intravenous- or subcutaneous-dose dosing phase (e.g., total doses of
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`2.1, 2.8, or 3.65 mg/kg per dosing period), which, following Petitioner’s
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`bioavailability calculation, would be expected to require even higher doses when
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`administered orally. Ex. 1002, 2:37-42; Ex. 1018, 7 (Table III); Pet. 47.
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`Occasionally, a subsequent cladribine retreatment phase followed the initial
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`dosing phase, using dosages different from those of initial dosing. See Ex. 1018, 7
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`(Table III, “Polish RRMS pilot” using “10mg [oral] x 5 days q1mo x 6 courses,
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`then 2 further courses at 3mo intervals”). One clinical study retreated some
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`patients with a lower dose than that of the initial treatment “because of a
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`recurrence of disease worsening.” See Ex. 1016, 5 (citing Ex. 1027); Ex. 1027, 1,
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`4; Section VI.A.2.c, infra.
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`6
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`Nonetheless, despite the numerous clinical trials conducted with varying
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`dosing periods and doses, “cladribine was not found to be effective against MS
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`clinical deterioration.” Ex. 1026, 4.
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`In the meantime, as of December 2004, there were significant long-term
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`safety concerns about using cladribine to treat MS, including increased cancer risk,
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`hematologic toxicity, and that “the risks of patients absorbing the entire dose and
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`experiencing bone marrow suppression is … too great to warrant use of cladribine
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`by the oral route.” Ex. 1018, 12; Ex. 1016, 5-6; Ex. 1027, 5; Ex. 1031, 4. At the
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`time, “there [were] few data on the safety of long-term treatment with cladribine in
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`a nonmalignant disease such as MS.” Ex. 1016, 5. “[T]he possibility of
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`malignancies occurring long after administration … cannot be dismissed.” Ex.
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`1027, 5.
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`III. PERSON OF ORDINARY SKILL IN THE ART
`PO reserves the right to challenge Petitioner’s definition of a POSA at a later
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`stage in this proceeding, should the Board institute trial.
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`IV. CLAIM CONSTRUCTION
`Petitioner contends that claim limitations regarding treatment of or
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`administering to patients having “RRMS or early SPMS” have no patentable
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`weight. Pet. 27-28. Petitioner is wrong at least because the limitation “oral
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`administration of … cladribine to an individual having [RRMS or early SPMS]” is
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`7
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`part of the claim body and thus is limiting. See Ex. 1002, 18:7-12 (claim 17); In re
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`Jasinski, 508 F. App’x 950, 952 (Fed. Cir. 2013) (finding the “language [in the
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`claim body to] refer to the essence of the invention,” and thus, limiting) (quotations
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`and citations omitted). Petitioner cites no contrary authority. Instead, Petitioner
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`relies on Pitney Bowes, Inc. v. Hewlett-Packard Co., presumably to support its
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`allegation that the preamble is non-limiting. 182 F.3d 1298, 1305 (Fed. Cir. 1999);
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`Pet. 27. However, here, as in Pitney Bowes, the preamble in the challenged claims,
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`“[a] method of treating [RRMS or early SPMS],” is “necessary to give life,
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`meaning, and vitality to the claim” and thus is limiting. Pitney Bowes, 182 F.3d at
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`1306 (quotations and citations omitted). See also Eli Lilly & Co. v. Teva Pharms.
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`Int’l GmbH, 8 F.4th 1331, 1340-42 (Fed. Cir. 2021) (holding that preambles in
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`“method claims [are construed] as limiting” if they “embody the essence of the
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`claimed invention” by stating “the intentional purpose for which the method[s]
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`must be performed.”).
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`PO reserves the right to construe additional claim terms at a later stage in
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`this proceeding, should the Board institute trial.
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`V. THE PETITION SHOULD BE DENIED UNDER 35 U.S.C. § 325(D)
`This case represents the exact scenario of wasting of judicial resources that
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`§ 325(d) was designed to prevent. Under Advanced Bionics, the Board may
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`exercise its discretionary denial by considering “whether the same or substantially
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`8
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`the same art [or arguments] previously was presented to the Office;” and “if either
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`condition of first part of the framework is satisfied, whether the petitioner has
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`demonstrated that the Office erred in a manner material to the patentability of
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`challenged claims.” Advanced Bionics, LLC v. Med-El Elektromedizinische
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`Gerate GmbH, IPR2019-01469, Paper 6 at 8 (P.T.A.B. Feb. 13, 2020)
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`(precedential). Both prongs strongly favor discretionary denial.
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`Petitioner’s three grounds rely on two references. Bodor, the key reference
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`on which all grounds rely, and Rice, the secondary reference, were both before the
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`Office. Petitioner’s arguments based on Bodor were already raised by the
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`Examiner and overcome by PO during prosecution. Thus, the Office already
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`considered Petitioner’s prior art and arguments.
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`Further, Petitioner has not “demonstrated that the Office erred in a manner
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`material to the patentability[.]” Id., 8. Contrary to Petitioner’s allegations, the
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`record indicates that the Examiner understood the law and did not misconstrue any
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`claim scope. At best, Petitioner merely disagrees with the Examiner’s conclusions.
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`In such situations, “it cannot be said that the Office erred in a manner material to
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`patentability.” Id., 9. The Board should decline to institute this IPR.
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`A. The Office Already Considered Petitioner’s Alleged Prior Art
`And Arguments
`In evaluating whether the same or substantially the same art or arguments
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`were presented previously to the Office, the Board considers Becton Dickinson
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`factors (a), (b), and (d): (a) similarities and material differences between the
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`asserted art and the prior art involved during examination; (b) the cumulative
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`nature of the asserted art and the prior art evaluated during examination; and (d)
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`the extent of the overlap between the arguments made during examination and the
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`manner in which Petitioner relies on the prior art or PO distinguishes the prior art.
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`See id., 9-10; Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-
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`01586, Paper 8 at 17-18 (P.T.A.B. Dec. 15, 2017)). Here, all three factors favor
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`denial.
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`1.
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`Becton Dickinson Factors (a) And (b): Asserted Art Was
`Considered During Examination
`Grounds I and II rely on Bodor. Ground III additionally relies on Rice (Ex.
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`1008). Petitioner states that “the same primary reference (Bodor) is used in both
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`the Petition and during prosecution.” Pet. 18. Bodor’s counterpart—Bodor ’101
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`(Ex. 1007), which Petitioner states has the same disclosure as Bodor (Pet., 24,
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`n.4)—and Rice were considered by the Examiner during prosecution. The
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`Examiner cited Bodor ’101 in Office Actions during prosecution of the ’903 patent
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`and its parent patent, U.S. Patent No. 7,713,947. See Ex. 1004, 103-106, 108-109,
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`139-142, 144-145; Ex. 1003, 388-394. During prosecution of both patents, PO and
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`the Examiner extensively discussed Bodor ’101. Ex. 1004, 103-106, 108-109,
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`124-126, 129-130, 139-142, 144-145, 153-158; Ex. 1003, 388-394, 414-418, 420-
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`422. PO overcame the Examiner’s rejections based on Bodor ’101. Ex. 1004,
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`124-131, 153-158, 162-163, 180-184. Bodor ’101 is also expressly referenced in
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`the ’903 patent’s specification. Ex. 1002, 6:20-24, 11:61-67, 14:28-32, 14:47-48.
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`Thus, the same primary reference of the Petition in all Grounds was fully
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`evaluated and overcome during examination.
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`Petitioner acknowledges “[t]he Examiner considered Rice” in an IDS. Pet.
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`17; see also Ex. 1004, 117 (“ALL REFERENCES CONSIDERED … /K.B./”).
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`Rice is also discussed in the ’903 patent specification. Ex. 1002, 2:43-49, 2:56-58.
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`Rice was before the Office and considered during Examination, thus satisfying
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`Advanced Bionics step one and demonstrating that Becton Dickinson Factors (a)
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`and (b) weigh strongly in favor of denial.
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`2.
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`Becton Dickinson Factor (d): Petitioner’s And The
`Examiner’s Arguments Are Not Materially Different
`Petitioner’s central argument is the same as the Examiner’s argument
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`overcome during prosecution. Petitioner argues that Bodor teaches a maintenance
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`period after the ten-month cladribine-free period. Pet. 34-35 (“a [POSA] would
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`infer that the two-month cladribine treatment round restarts at the end of the
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`specified 10-month cladribine-free period”), 42-43. The Examiner made the same
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`argument before ultimately withdrawing her rejection. Ex. 1004, 103-104
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`(“because Bodor states ‘10 months of no treatment’, ... it is implied that treatment
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`may begin again following the nontreatment period”), 141, 180-184; Ex. 1003,
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`389, 466-472. Petitioner asserts that its own argument is “a position already
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`accepted, endorsed, and affirmed by the Office. The Examiner understood Bodor
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`to implicitly teach that the cladribine therapy resumed at the end of the ten-month
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`non-treatment period.” Pet. 36. There is thus substantial overlap between
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`prosecution arguments and Petitioner’s arguments for Grounds I and II. Indeed,
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`the Examiner already considered Petitioner’s arguments as to whether Bodor
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`taught a maintenance period and ultimately withdrew her rejections.
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`Petitioner argues that Ground III differs because it includes Rice. Id., 17-18.
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`Because Bodor does not disclose repeating cladribine administration, Petitioner
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`alleges “Rice teaches to administer [cladribine], cease administration, and then
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`repeat.” Id., 7, 50-51. The Examiner made the same argument based on a
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`different reference, Grieb.2 The Examiner argued that “even if … [a POSA] would
`
`not have taken Bodor’s therapeutic regimen … to imply that treatment should be
`
`resumed at the end of [the no-treatment] period,” a POSA would have been aware
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`2 Grieb et al., Arch. Immunol. Therap. Exp. 1995; 43:323-327.
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`of teachings like Grieb, “which clearly indicate a repetitive treatment regimen
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`comprising periods of cladribine therapy separated by periods of no treatment[.]”
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`Ex. 1004, 142. Thus, Petitioner’s Ground III argument at best repeats the same
`
`argument made by the Examiner based on Bodor and Grieb and overcome by the
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`PO during prosecution, now based on Bodor in combination with a different
`
`reference, Rice.
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`Accordingly, Factor (d) weighs strongly in favor of denial.
`
`B.
`Petitioner Has Not Identified A Material Error By The Examiner
`In evaluating whether Petitioner “has demonstrated that the Office erred in a
`
`manner material to the patentability of challenged claims,” the Board considers
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`Becton Dickinson factors (c), (e), and (f): (c) the extent to which the asserted art
`
`was evaluated during examination, including whether the prior art was the basis for
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`rejection; (e) whether Petitioner has pointed out sufficiently how the Examiner
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`erred in its evaluation of the asserted prior art; and (f) the extent to which
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`additional evidence and facts presented in the Petition warrant reconsideration of
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`prior art or arguments. See Advanced Bionics, IPR2019-01469, Paper 6 at 9-10.
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`Analysis of these factors confirms Petitioner has failed to identify any material
`
`error or present additional evidence or facts that warrant institution.
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`Becton Dickinson Factor (c): Asserted Art Was Evaluated
`During Examination
`Factor (c) favors denial because Petitioner’s asserted art was evaluated
`
`1.
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`thoroughly during prosecution. The Examiner fully evaluated and relied upon
`
`Bodor ’101 as a basis for rejections during prosecution of the ՚903 and ՚947
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`patents. See Section V.A, supra; Ex. 1004, 103-106, 108-109, 139-142, 144-145;
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`Ex. 1003, 388-394.
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`Although the claims were not rejected over Rice, Factor (c) does not require
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`that “each and every argument set forth in the petition must have been previously
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`presented.” Ziegmann v. Stephens, IPR2015-01860, Paper 13 at 19 (P.T.A.B. Sept.
`
`6, 2017). As shown by the signed IDS and admitted by Petitioner, the Examiner
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`considered Rice. See Pet. 17; Ex. 1004, 117; R.J. Reynolds Vapor Co. v. Fontem
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`Holdings 1 B.V., IPR2017-01642, Paper 10 at 6 (P.T.A.B. Jan. 16, 2018)
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`(references listed on IDS and signed off by Examiner but not discussed were
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`“considered”).
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`Petitioner argues that the grounds differ because Rice is included and
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`conjectures that the Examiner “likely disregarded Rice’s teaching because she was
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`focused on finding a reference that teaches different dosages during two different
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`administration periods.” Pet. 17. But, according to Petitioner, the Examiner
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`“understood Bodor to teach two cladribine administration periods having equal
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`cladribine dosages in each period.” Id., 16. Thus under Petitioner’s theory Rice is
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`cumulative: the Examiner would not have needed Rice for its alleged “same
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`dosage” teachings. Accordingly, based on Petitioner’s own arguments, the
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`addition of Rice does not warrant reconsideration of prior art and arguments
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`previously considered by the Office.
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` Furthermore, Petitioner’s Ground III at best repeats the argument overcome
`
`by PO during prosecution based on Bodor in combination with a different
`
`reference, as explained above. See Section V.A.2, supra. Thus, Factor (c) also
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`weighs against institution.
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`2.
`
`Becton Dickinson Factor (e): Petitioner Has Not Identified
`Any Examiner Error
`“[W]hen a prior art reference presented in a petition was already considered
`
`substantively … [during examination], the petitioner has the initial burden to
`
`identify such errors made by the examiner with respect to that … reference.”
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`Ziegmann, IPR2015-01860, Paper 13 at 10.
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`Petitioner fails to identify any error by the Examiner.
`
`Petitioner argues that “the Examiner either did not understand …
`
`anticipation of ranges (i.e., error of law), or the Examiner misconstrued the scope
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`of the claimed range in claim 17 to mean that the total cladribine dosage in the
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`induction phase must be one of the numbers higher than 1.7 mg/kg[.]” Pet. 15.
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`Petitioner relies on these alleged errors to wrongly suggest the Grounds differ from
`
`those presented during prosecution. Id., 15, 17-18.
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`First, the record contradicts Petitioner’s allegation that the Examiner “did
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`not understand … the anticipation of ranges[.]” Id., 15. The Examiner made the
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`same argument that Petitioner currently makes in alleging that Bodor discloses a
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`specific dose within the claimed dose range, thus reading on the claimed range.
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`Compare Ex. 1004, 104 (“for an average adult human weighing approximately 65
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`kg, the total dose of cladribine reached at the end of this period would be 2.15
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`mg/kg …, which is within the range of about 1.7 mg/kg to about 3.5 mg/kg as in
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`base claims 1 and 17”), with Pet. 33 (“for a lighter human, perhaps weighing 59 kg,
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`a clinician may decrease the dosage to 10 days, which results in 1.69 mg/kg …
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`[and] anticipate[s]” the claimed range). The Examiner thus alleged that Bodor
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`discloses specific doses within the claimed ranges, indicating her understanding
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`that a single value within a claimed range can affect the claim’s validity.
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`Here, the substance of Petitioner’s and the Examiner’s arguments is the
`
`same; Petitioner merely disagrees with the Examiner’s ultimate determination to
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`allow the claims, which does not amount to material error. As explained in
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`Advanced Bionics, “[i]f reasonable minds can disagree regarding the purported
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`treatment of the art or arguments, it ca
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