`
`Paper 9, April 27, 2023
`
`In the United States Patent and Trademark Office
`
`Before the Patent Trial and Appeal Board
`
`TWI PHARMACEUTICALS INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`U.S. Patent No. 8,377,903
`Ser. No. 12/766,173
`Issue Date: Feb. 19, 2013
`Title: Cladribine Regimen for Treating Multiple Sclerosis
`
`Case No. IPR2023-00050
`
`Patent No. 8,377,903 B2
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S REQUEST FOR REHEARING OF DENIAL OF
`INSTITUTION
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`
`
`
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`
`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS ........................................................................................ ii
`
`TABLE OF AUTHORITIES ................................................................................. iii
`
`I.
`
`Statement Of Precise Relief Requested ...................................................... 1
`
`II. Legal Standard ............................................................................................ 2
`
`III. Background, Including Statement of Facts Materials to Rehearing. ......... 3
`
`IV. Argument, With Full Statement of the Reasons for Relief Requested ....... 9
`
`A. The Decision Misapprehended or Overlooked the Treatment of
`Weight-Based Dosing in Both the’903 Patent and in Bodor. ............. 9
`
`B. The Decision Erred as a Matter of Law in Applying Inherency. ...... 11
`
`C. The Decision Overlooks or Misapprehends the Sufficiency of
`Bodor’s Disclosure During the Maintenance Period. ...................... 13
`
`D. The Decision Overlooks or Misapprehends the Basis for
`Obviousness over Bodor in Light of the Level of Ordinary Skill. .... 14
`
`E. The Decision Overlooks or Misapprehends the Combination of
`Bodor and Rice 2000. ....................................................................... 15
`
`V. Conclusion ................................................................................................ 15
`
`
`
`
`
`– ii –
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`
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`AdjustaCam, LLC v. NewEgg, Inc.,
`861 F.3d 1353 (Fed. Cir. 2017) .............................................................................. 2
`Arnold P’ship v. Dudas,
`362 F.3d 1338 (Fed. Cir. 2004) .............................................................................. 3
`CommScope Techs. LLC v. Dali Wireless Inc.,
`10 F.4th 1289 (Fed. Cir. 2021) ............................................................................. 14
`Ecolab, Inc. v. FMC Corp.,
`569 F.3d 1335 (Fed. Cir. 2009) ............................................................................ 14
`Hewlett-Packard Co. v. Mustek Sys., Inc.,
`340 F.3d 1314 (Fed. Cir. 2003) ............................................................................ 12
`Ineos USA LLC v. Berry Plastics Corp.,
`783 F.3d 865 (Fed. Cir. 2015) .............................................................................. 12
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................. 15
`Lewmar Marine, Inc. v. Barient, Inc.,
`827 F.2d 744 (Fed. Cir. 1987) .............................................................................. 14
`Peters v. Active Mfg. Co.,
`129 U.S. 530 (1889) ............................................................................................. 14
`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005) .............................................................................. 3
`Titanium Metals Corp. v. Banner,
`778 F.2d 775 (Fed. Cir. 1985) .............................................................................. 12
`UCB, Inc. v. Actavis Lab'ys UT, Inc.,
`No. 2021-1924, 2021-2336,
`2023 WL 2904757,
`[65 F.4th 679] (Fed. Cir. 2023) ............................................................................ 12
`
`– iii –
`
`
`
`
`
`Ultratec, Inc. v. CaptionCall, LLC,
`872 F.3d 1267 (Fed. Cir. 2017) .............................................................................. 2
`REGULATIONS
`37 C.F.R. § 42.71 ....................................................................................................... 2
`
`– iv –
`
`
`
`
`
`I.
`
`Statement Of Precise Relief Requested
`
`Petitioner TWi Pharmaceuticals Inc. respectfully requests rehearing of the
`
`Decision Denying Institution of Inter Partes Review, Paper 8 (“Decision”) because
`
`the Decision overlooked or misapprehended that it allows Patent Owner to remove
`
`from the public domain use of the very treatment disclosed in Bodor (Ex. 1029) on
`
`a patient of average weight and claim an exclusive property right in that previously
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`disclosed treatment. The Decision overlooked or misapprehended the scope of the
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`prior art references (including materials incorporated by reference therein) and
`
`mistakenly applied an inherency standard (where instead the claim reads directly on
`
`the prior art disclosure) to conclude, incorrectly, that the Petitioner has not
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`demonstrated a reasonably likelihood of showing invalidity over the prior art.
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`Petitioner respectfully requests that the Board grant rehearing and institute inter
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`partes review of claims 17, 19–20, and 22–29 (“Challenged Claims”) of U.S. Patent
`
`No. 8,377,903 (“the ’903 patent”) (Ex. 1002). This Request is timely filed within 30
`
`days of the entry of the Decision.
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`It is undisputed that the Challenged Claims do not include a limitation
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`requiring that the total dose of Cladribine during the “maintenance period” be lower
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`than the total dose of Cladribine during the “induction period,” which the patent
`
`repeatedly characterizes as the invention. The patent never describes “weight-based”
`
`dosing as the invention but instead admits that expressing cladribine dosage in terms
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`– 1 –
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`
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`
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`of weight was old and known in the art. The Decision treats the Challenged Claims
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`as though they recited a “weight-based method” different from what it calls the “flat
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`dosing method” of Bodor. But the dosages in Bodor when administered to any
`
`patient (including a patient of average weight) necessarily correspond to a total dose
`
`in mg/kg of that patient’s body mass, which is just a different expression. The dosage
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`regimen of the Challenged Claims does not vary day-to-day based on weight but
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`instead reads on a flat dosage over the induction period and the maintenance for a
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`given total dose. And Bodor discloses expressing dosage in mg/kg both in the text
`
`of the document itself and in other art it expressly incorporates by reference.
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`II. Legal Standard
`
`A rehearing request must identify matters the decision “misapprehended or
`
`overlooked” and “where each matter was previously addressed.” 37 C.F.R. §
`
`42.71(d). The Board reviews its decision for abuse of discretion. Id. § 42.71(c). An
`
`abuse of discretion occurs when a decision makes a legal error, clear factual error,
`
`or clearly erroneous assessment of the evidence. AdjustaCam, LLC v. NewEgg, Inc.,
`
`861 F.3d 1353, 1358 (Fed. Cir. 2017); Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d
`
`1267, 1272 (Fed. Cir. 2017) (“(1) is clearly unreasonable, arbitrary, or fanciful; (2)
`
`is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact
`
`findings; or (4) involves a record that contains no evidence on which the Board could
`
`rationally base its decision.”). Abuse of discretion may be indicated if the decision
`
`– 2 –
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`
`
`
`
`is based on an erroneous interpretation of law, if a factual finding is not supported
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`by substantial evidence, or if the decision represents an unreasonable judgment in
`
`weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281
`
`(Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004).
`
`III. Background, Including Statement of Facts Materials to Rehearing.
`
`Petitioner stated three grounds of invalidity in its Petition for Inter Partes
`
`Review of U.S. Patent No. 8,377,903 under 45 U.S.C. §§ 311–319 and 37 C.F.R.
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`§§ 42.100 et seq. at 24, Paper 1 (“Petition”). The primary reference in each ground
`
`is Bodor (Ex. 1029), which (as the prosecution history shows) disclosed the claimed
`
`treatment method if the total dose in the maintenance period is not lower than that
`
`in the initial period. (See Ex. 1004 at 103–106 (“The difference, therefore, is that
`
`neither of the above references teach that the total dose of cladribine reached at the
`
`end of the maintenance phase is lower than the total dose reached at the end of the
`
`induction phase.”).) Ground I is that the Challenged Claims are anticipated by Bodor
`
`(Ex. 1029). Petition at 24. Ground II is that the Challenged Claims are obvious over
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`Bodor in view of the common knowledge of one of ordinary skill in the art. Id.
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`Ground III is that the Challenged Claims are obvious over Bodor in view of Rice
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`2000 (Ex. 1008). Id.
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`The ’903 patent does not purport to have invented “weight-based” oral dosing.
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`On the contrary, the ’903 patent specification admits that expressing dosage in mg/kg
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`– 3 –
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`
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`of the patient’s body mass was already well-known in the art, including for cladribine
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`to treat MS. (Ex. 1002, col. 2, ℓℓ. 31–49.) It cites Selby 1998 (Ex. 1031) as disclosing
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`a cladribine weight-based dose of 0.1 mg/kg/day. (Ex. 1002, col. 2, ℓℓ. 37–39.) It
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`cites Romine 1999 (Ex. 1016) as disclosing a weight-based dose of 0.07 mg/kg/day.
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`(Ex. 1002, col. 2, ℓℓ. 40–42.) It also cites Rice 2000 (Ex. 1008) as disclosing a
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`weight-based dose of 0.07 mg/kg/day. (Ex. 1002, col. 2, ℓℓ. 43–49.)
`
`The ’903 patent specification describes its alleged invention as “an improved
`
`dosing regimen” (Ex. 1002, col. 3, ℓℓ. 42–43) which it repeatedly characterizes as
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`“the total dose of Cladribine reached at the end of the maintenance period is lower
`
`than the total dose of Cladribine reached at the end of the induction period” (Ex.
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`1002, col. 3, ℓℓ. 60–63; col. 4, ℓℓ. 8–11; col. 8, ℓℓ. 32–34; col. 9, ℓℓ. 40–43; col. 9,
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`ℓ. 67–col. 10, ℓ. 4; col. 10, ℓℓ. 19–23, 46–49; col. 12, ℓℓ. 19–21, 37–41, 56–59.).
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`The specification says that with this regimen “adverse effects are reduced, allowing
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`further use of Cladribine.” (Ex. 1002, col. 3, ℓℓ. 47–48; see col. 5, ℓℓ. 19–24.)
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`The prosecution history confirms this understanding. The Examiner rejected
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`all claims over Bodor and other references, stating that the only difference from the
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`claims was that Bodor did not “teach that the total dose of cladribine reached at the
`
`end of the maintenance phase is lower than the total dose reached at the end of the
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`induction phase.” (Ex. 1004 at 106.) The response acquiesced in the Examiner’s
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`analysis that Bodor disclosed the same initial dosage but traversed that Bodor
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`– 4 –
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`
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`disclosed a maintenance period with a lower dose. (Ex. 1004 at 125 (“a ‘maintenance
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`period’ during which a cladribine formulation is administered such that the total dose
`
`administered in the ‘maintenance period’ is lower than the total dose first
`
`administered to the patient… at a lower dosage in a manner that could be construed
`
`as a ‘maintenance period’.”), 156 (“Specifically, one skilled in the art would not have
`
`had any reason to reduce the dosage of cladribine administered during the
`
`‘maintenance period’ as recited in the claims such that the total dosage of cladribine
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`administered to the patient is less than the total dose of cladribine the patient received
`
`during the induction period.”).) It was only by arguing that the maintenance period
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`required a lower dose that applicant was deemed to have overcome the rejection.
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`The examiner, however, did not notice that the Challenged Claims omitted
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`this critical limitation that the total dose in the “maintenance period” be less than the
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`total dose in the “induction period.” Because of that omission, Bodor (Ex. 1029)
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`anticipates and/or Bodor in combination with the level of ordinary skill and/or with
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`Rice 2000 (Ex. 1008) renders obvious the Challenged Claims.
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`Bodor discloses “weight-based” dosing (i.e., total dose expressed as mg/kg)
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`both in the four corners of the document and in other materials it incorporates by
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`reference. First, Bodor itself expressly discloses such “weight–based” dosing in
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`mg/kg. (Ex. 1029, col. 12, ℓℓ. 53–58 (“Therapeutically effective dosages described
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`in the literature include…for multiple sclerosis (from about 0.04 to about 1.0
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`– 5 –
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`
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`
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`mg/kg/day …).” (emphasis added).) Bodor also incorporates by reference numerous
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`articles which also disclose this “weight-based” expression of dosage. (Ex. 1029,
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`col. 4, ℓℓ. 36–40 (“The patents, published applications, and scientific literature
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`referred to herein establish the knowledge of those with skill in the art and are hereby
`
`incorporated by reference in their entirety to the same extent as if each was
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`specifically and individually indicated to be incorporated by reference.”).)
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`Among others, Bodor lists the same three references of Selby 1998 (Ex. 1031),
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`Romine 1999 (Ex. 1016), and Rice 2000 (Ex. 1008) that the ’903 patent specification
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`(Ex. 1002, col. 2, ℓℓ. 31–49) had admitted to being prior art disclosing weight-based
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`dosing. Selby 1998 (Ex. 1031, cited at Ex. 1029, col. 13, ℓℓ. 2–3) teaches weight-
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`based dosing of cladribine by reporting a clinical study where “Cladribine
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`(Leustatin7®, Ortho-Biotech) was administered at a dose of 0.07 mg/kg/day by
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`subcutaneous injection for 5 days per cycle, or 0.35 mg/kg/cycle, repeated every 4
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`weeks for 6 cycles in total.” (Ex. 1031 at 2 (emphasis added).) Romine 1999 (Ex.
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`1016, cited at Ex. 1029, col. 12, ℓ. 67–col. 13, ℓ. 2) discloses a clinical study where
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`“[e]ach patient received a course of five consecutive daily subcutaneous injections
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`of cladribine, 0.07 mg/kg/day … given monthly for 6 months for a total cumulative
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`dose of 2.1 mg/kg of cladribine.” (Ex. 1016 at 2 (emphasis added).) Rice 2000 (Ex.
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`1008, cited at Ex. 1029, col. 13, ℓ. 5) also teaches weight-based dosing where the
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`total dose administered during the first year is 0.7 mg/kg and 2.1 mg/kg. (Ex. 1008
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`– 6 –
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`
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`at 2 (“Patients received six courses of cladribine 0.07 mg/kg/day SC for 5
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`consecutive days (total dose, 2.1 mg/kg), followed by two courses of placebo or two
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`courses of cladribine 0.07 mg/kg/day SC for 5 consecutive days (total dose, 0.7
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`mg/kg), followed by six courses of placebo or eight courses of placebo SC for 5
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`consecutive days.”) (emphasis added).). In addition to the general incorporation by
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`reference above, Bodor explicitly states of these references “all of which are
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`incorporated by reference herein in their entireties and relied upon.” (Ex. 1029, col.
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`13, ℓℓ. 7–8.)
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`Other references also included within Bodor’s incorporation by reference
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`similarly disclose weight-based dosing and were included as exhibits with the
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`Petition. Liliemark (Ex. 1009, cited at Ex. 1029, col. 1, ℓ. 55) teaches that cladribine
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`“when administered orally at about twice the intravenous dose, the areas under the
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`concentration-time curve (AUC) are similar” and taught weight-based dosing where
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`intravenous infusions of 0.12 mg/kg and 0.24 mg/kg were administered. (Ex. 1009
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`at 3.) Tortorella (Ex. 1026, cited at Ex. 1029, col. 13, ℓℓ. 3–5) is a review article with
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`numerous examples of such “weight-based” dosing expressions. (Ex.1026 at 2
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`(“cladribine was administered sc at 0.07 mg/kg for 5 consecutive days for 2 to 6
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`monthly courses, ie, at a total dose of 0.7 to 2.1 mg/kg” and “monthly courses of
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`0.07 to 0.1 mg/kg cladribine/ day for 7 days” and “recommended cladribine doses
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`for MS treatment (0.7 and 2.1 mg/kg)” (emphasis added)); at 3 (“each subject
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`– 7 –
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`
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`received seven daily infusions of 0.1 mg/kg of cladribine each month (total dosage:
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`2.8 mg/kg)” and “Cladribine 2.8 mg/kg was effective in…” and “[t]he Scripps C
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`study was designed to evaluate the efficacy and safety of cladribine 2.1 mg/kg in 52
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`patients with RRMS” and “159 MS patients… randomly received 2.1 mg/kg or 0.7
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`mg/kg of cladribine or placebo.”) (emphasis added)); and at 5 (Table titled
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`“Clinical”).)
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`Bodor also teaches treating patients using an oral administration method of a
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`cladribine formulation (Ex. 1029, col. 13, ℓℓ. 9–30, col. 12, ℓℓ. 43–52; Ex. 1005, ¶¶
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`97–98) and the ’903 patent specifically recites the Bodor formulation as one of its
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`embodiments (Ex. 1002, col. 6, ℓ. 23; col. 11, ℓℓ. 61–67; col. 14, ℓ. 32).
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`In addition to disclosing “weight-based” oral dosing, Bodor also describes and
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`discloses a repeated dosing regimen as follows:
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`At the present time, it is envisioned that, for the treatment of
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`multiple sclerosis, 10 mg of cladribine in the instant complex
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`cladribine-cyclodextrin complex in the instant solid dosage form would
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`be administered once per day for a period of five to seven days in the
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`first month, repeated for another period of five to seven days in the
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`second month, followed by ten months of no treatment.
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`(Ex. 1029, col. 13, ℓℓ. 19–25.) Ten months of “no treatment” necessarily means that
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`the treatment is then repeated, otherwise the “no treatment” period would never end
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`– 8 –
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`
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`and would not last for only ten months. (See Ex. 1004 at 104, 141.)
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`Moreover, the 5 to 7 days dosing regimen in Bodor accommodates adapting
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`or fine tuning the dosing regimen to factors including the patient’s weight, as was
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`already well-known in the art. As a matter of simple mathematics, dosing for 5 days
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`for each of two months results in a 1.67 mg/kg dose for a 60 kg (~132 pound) patient.
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`Dosing the intermediate 6 days for each of two months results in 1.71 mg/kg in a 70
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`kg (~154 pound) patient, which a person of ordinary skill would consider average.
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`(Ex. 1005 ¶ 105.) Dosing 7 days for each of two months results in 1.75 mg/kg for an
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`80 kg (176 pound) patient. Combining 5 and 6 or 6 and 7 days allows for finer
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`adjustments, and all lead to the claimed about 1.7 mg/kg for patients in a normal
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`range of body mass. (Ex. 1005 ¶¶ 101–107; Ex. 1004 at 107.)
`
`IV. Argument, With Full Statement of the Reasons for Relief Requested
`
`A.
`
`The Decision Misapprehended or Overlooked the Treatment of
`Weight-Based Dosing in Both the’903 Patent and in Bodor.
`
`Contrary to Patent Owner’s argument and the Decision, the ’903 patent does
`
`not purport to have invented “weight-based” dosing. The term “weight-based” does
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`not appear anywhere in the disclosure. The claims, (including not only the
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`Challenged Claims but also other claims), recite the “total dose” administered in the
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`induction period and in the maintenance period in mg/kg, but the patent’s discussion
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`under the heading “Background of the Invention” makes clear that this expression
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`of the total dose was well-known in the art and not the invention of the ’903 patent.
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`– 9 –
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`Moreover, Bodor not only expressly discloses expressing dosage in mg/kg, it also
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`incorporates by reference the art cited in the ’903 patent disclosing that expression.
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`Petitioner previously addressed this point in Petition at 9, 29–33, 45–48, & 52–55.
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`The Decision states, “Petitioner has not shown, nor do we see, any description
`
`in Bodor implementing that weight-based dosage approach for Bodor’s treatment
`
`method.” (Decision at 13.) But that is not the standard for disclosure or anticipation.
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`Bodor is anticipatory for all that it discloses, not just for what it claims or
`
`exemplifies. Regardless of whether it recited that well-known prior art expression of
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`dosage in its treatment method, it is undisputed that it disclosed that form of dosing,
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`and the ’903 patent admits that form of dosing was not novel, citing the same art that
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`Bodor incorporates by reference.
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`The Decision also states, “Whether administered for 10 days or up to 14 days
`
`during the treatment period, the daily dosage remains a fixed amount.” (Decision at
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`13.) But that is not a distinction. The Challenged Claims of the ’903 patent recite no
`
`limitation about whether the “daily dosage” varies or remains fixed. Instead, it’s
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`limitations are directed to the “total dose” administered during the induction period
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`and maintenance period (which can be in equal daily doses), and the ranges it recites
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`encompass data points disclosed in Bodor for a person of average mass. And
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`Mavenclad®, alleged to be a commercial embodiment of the ’903 patent, instructs
`
`taking 10 mg tablets for two treatment weeks one month apart, just as Bodor taught.
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`– 10 –
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`(Ex. 1011 at 30.)
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`Because “weight-based” amounts are not a valid distinction for the ’903
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`patent, and because Bodor discloses the same recitations of “weight-based” dosing
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`expressions as recited in the ’903 patent, Petitioner has demonstrated a reasonable
`
`likelihood of establishing that Bodor discloses a method of treating MS with an oral
`
`dosage of cladribine, wherein the total dose of cladribine reached at the end of the
`
`induction period and at the end of the maintenance period is about 1.7 mg/kg. (See
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`Decision at 12–13)
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`B.
`
`The Decision Erred as a Matter of Law in Applying Inherency.
`
`The Decision denying institution also errs as a matter of law in its anticipation
`
`analysis. It states, “Petitioner’s examples involve a strategic selection of patient
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`weight and treatment duration that support a calculation that yields a 1.7 mg/kg total
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`dosage for the treatment period” and that “such a strategy is insufficient to establish
`
`inherency as it demonstrates only the total dose that is possible for some patients.”
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`(Decision at 14.) But inherency is a red herring. The Petition did not make an
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`inherency argument. The word “inherently” appears only once (Petition at 25) in a
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`quotation of the general standard for anticipation, not in analyzing any prior art.
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`Instead, the Petition points out that specific recited data points in Bodor (such as
`
`administering 120 mg in 10mg/day for 6 days each for the first and second months)
`
`would fall within the ranges recited in the claims for what a person of ordinary skill
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`– 11 –
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`
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`
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`would understand to be an average human weight of 70 kg. (Ex. 1005 at 54–55,
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`¶ 105.) As the Federal Circuit has recently explained, disclosure of a point that falls
`
`within the claimed range is sufficient for anticipation:
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`“Our precedent sets forth an established framework for analyzing
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`whether a prior art reference anticipates a claimed range. … If the prior
`
`art discloses a point within the claimed range, the prior art anticipates
`
`the claim.”
`
`UCB, Inc. v. Actavis Lab'ys UT, Inc., No. 2021-1924, 2021-2336, 2023 WL 2904757,
`
`*4 [65 F.4th 679] (Fed. Cir. 2023) (emphasis added) (citing Ineos USA LLC v. Berry
`
`Plastics Corp., 783 F.3d 865, 869 (Fed. Cir. 2015); Titanium Metals Corp. v. Banner,
`
`778 F.2d 775, 782 (Fed. Cir. 1985)). Moreover, “strategic selection” does not avoid
`
`anticipation because “a prior art product that sometimes, but not always, embodies
`
`a claimed method nonetheless teaches that aspect of the invention.” Hewlett-Packard
`
`Co. v. Mustek Sys., Inc., 340 F.3d 1314, 1326 (Fed. Cir. 2003). This is not a case of
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`overlapping ranges, and certainly not a case of “inherency” of unstated values.
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`Instead, one or more of Bodor’s specific dosing regimes fall within the claim. Even
`
`if this “point within the claimed range” were an outlier of the points disclosed that
`
`would not matter and the reference would still anticipate—but here it is not even an
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`outlier. It is in the middle of the points disclosed. Petitioner previously addressed the
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`correct standard for anticipation in Petition at 13–14, 25–26, 30, 36–37.
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`– 12 –
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`C.
`
`The Decision Overlooks or Misapprehends the Sufficiency of
`Bodor’s Disclosure During the Maintenance Period.
`
`The Decision overlooks or misapprehends the scope of the Challenged Claims
`
`when it states, “Petitioner has not identified disclosures in Bodor that adequately
`
`support Petitioner’s assertion that a subsequent round of Bodor’s therapy, during
`
`what Petitioner refers to as the maintenance period, would necessarily be at the same
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`dosage administered in the first round.” (Decision at 14.) But the Challenged Claims
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`do not require the maintenance period to be at the same dosage—the issue is that
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`they allow the maintenance period to be at the same dosage, which Bodor also
`
`discloses. Despite repeatedly describing its alleged invention as requiring a lower
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`total dose in the maintenance period, as stated in both the specification and the
`
`prosecution history remarks, the ’903 patent omitted that key limitation from the
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`Challenged Claims. Because the Challenged Claims do not require a lower total dose
`
`during the maintenance period, Bodor discloses the entire method. The speculation
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`that the dosage could be adjusted during the maintenance period does not take the
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`disclosure outside the scope of the claims, and additional motivation to repeat the
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`cycles is seen in prior art such as Beutler (Ex. 1027) which had shown an improved
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`therapeutic response for multi-year treatments. One practicing Bodor, using exactly
`
`the specific dosage points disclosed, could be held to infringe the Challenged
`
`Claims. “As the Supreme Court has stated, ‘[t]hat which infringes, if later, would
`
`anticipate, if earlier.’” CommScope Techs. LLC v. Dali Wireless Inc., 10 F.4th 1289,
`
`– 13 –
`
`
`
`
`
`1294 (Fed. Cir. 2021) (citing Peters v. Active Mfg. Co., 129 U.S. 530, 537 (1889));
`
`see also Lewmar Marine, Inc. v. Barient, Inc., 827 F.2d 744, 747 (Fed. Cir. 1987);
`
`Ecolab, Inc. v. FMC Corp., 569 F.3d 1335, 1348 (Fed. Cir. 2009). Petitioner
`
`previously addressed this scope of the Challenged Claims in Petition at 1–2, 10, 12–
`
`19.
`
`D.
`
`The Decision Overlooks or Misapprehends the Basis for
`Obviousness over Bodor in Light of the Level of Ordinary Skill.
`
`In addition to the issues discussed above concerning the scope of the
`
`Challenged Claims and the disclosure of Bodor, the Decision also overlooks or
`
`misapprehends the evidence when it states, “What is missing from Petitioner’s
`
`argument is why, apart from hindsight, a skilled artisan would have exchanged
`
`Bodor’s flat dosing method for oral administration of a cladribine complex with the
`
`weight-based method disclosed in Rice for use with subcutaneous administration of
`
`cladribine.” (Decision at 20.) Nothing in the Challenged Claims excludes “flat
`
`dosing” with the same dose given every day during the induction period cycles and
`
`or during the maintenance period cycles. All that is required is that the total dose
`
`reach a stated level in each period, and Bodor discloses a total dose within that range
`
`for what a person of ordinary skill in the art would understand to be an average
`
`patient. Although in different units, the disclosure is in effect the same as that in the
`
`Challenged Claims and would have been obvious to one of ordinary skill in the art.
`
`Petitioner previously addressed this in Petition at 42–50.
`
`– 14 –
`
`
`
`
`
`E.
`
`The Decision Overlooks or Misapprehends the Combination of
`Bodor and Rice 2000.
`
`The Decision also misapprehends or overlooks the scope of the art in stating
`
`that “Petitioner’s proposed combination of Bodor and Rice involves modifying
`
`Bodor’s method of treating MS with a 10 mg daily oral dosage of its cladribine-
`
`cyclodextrin complex to instead depend upon a patient’s weight to determine an oral
`
`dosage amount, in view of the weight-based dosage disclosed in Rice for a
`
`subcutaneous cladribine treatment” and “Petitioner has not persuasively identified
`
`any teaching or suggestion in Rice or Bodor to convert Rice’s subcutaneous weight-
`
`based dosage to an orally administered weight-based dosage.” (Decision at 25–26.)
`
`But the Petition at 47 explained the calculation from Bodor for converting to oral
`
`strength based on bioavailability. Bodor also expressly incorporates by reference
`
`Rice 2000. (Ex. 1029, col. 13, ℓℓ. 5, 7–8.) As explained above that is anticipatory,
`
`but is also an express teaching, suggestion, and motivation to combine, even though
`
`that high standard is not required for obviousness. KSR Int’l Co. v. Teleflex Inc., 550
`
`U.S. 398, 415 (2007) (“[O]ur cases have set forth an expansive and flexible approach
`
`inconsistent with the way the Court of Appeals applied its TSM test here.”).
`
`Petitioner previously addressed this issue in Petition at 50–58.
`
`V.
`
`Conclusion
`
`For the reasons stated, Petitioner respectfully requests reconsideration and
`
`that trial be instituted on all three Grounds stated in its Petition.
`
`– 15 –
`
`
`
`
`
`Respectfully submitted,
`
`
`April 27, 2023
`
`
`
`
`
`
`/Philip D. Segrest, Jr./
`Philip D. Segrest Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`
`Nathan P. Sportel
`Steven R. Howe
`Backup Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`
`
`– 16 –
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.105, Petitioner certifies that the foregoing
`
`document was served via electronic mail to the attorneys of record in this proceeding
`
`at the following:
`
`Emily R. Whelan (Reg. No. 50,391)
`Emily.Whelan@wilmerhale.com
`Deric X. Geng, Ph.D. (Reg. No. 73,434)
`Deric.Geng@wilmerhale.com
`Cindy Kan (Reg. No. 76,385)
`Cindy.Kan@wilmerhale.com
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Counsel for Patent Owner
`
`April 27, 2023
`
`/Philip D. Segrest, Jr./
`Philip D. Segrest Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`
`Nathan P. Sportel
`
`Steven R. Howe
`Backup Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`
`
`– 17 –
`
`
`
`
`
`
`
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