From:
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`Hitchens, A. Lauren
`Precedential_Opinion_Panel_Request
`Emily.Whelan@wilmerhale.com; Deric.Geng@wilmerhale.com; Cindy.Kan@wilmerhale.com; Segrest, Philip; Sportel, Nathan; Howe, Steve
`IPR2023-00049; IPR2023-00050; Request for Precedential Opinion Panel Review
`Thursday, April 27, 2023 7:35:48 PM
`IPR2023-00050, Paper 09 2023.04.27 Petitioner"s Request for Rehearing ("903 Pat).pdf
`IPR2023-00049, Paper 11 2023.04.27 Petitioner"s Request for Rehearing ("947 Pat).pdf
`
`CAUTION: This email has originated from a source outside of USPTO. PLEASE CONSIDER THE SOURCE before responding, clicking on links, or opening
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`
`IPR2023-0049, U.S. Patent No. 7,713,947 B2
`IPR2023-0050, U.S. Patent No. 8,377,903 B2
`
`April 27, 2023
`
`Sent on Behalf of Philip D. Segrest, Jr.
`
`Based on my professional judgment, I believe the panel decisions (TWi Pharmaceuticals, Inc. v. Merck Serono S.A., No.
`IPR2023-00049 (P.T.A.B Mar. 28, 2023), Paper 10; TWi Pharmaceuticals, Inc. v. Merck Serono S.A., No. IPR2023-00049
`(P.T.A.B Mar. 28, 2023), Paper 8) are contrary to the following decision(s) of the Supreme Court of the United States, the
`United States Court of Appeals for the Federal Circuit, or the precedent(s) of the Board concerning the standard of
`anticipation:
`
`Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314 (Fed. Cir. 2003),
`UCB, Inc. v. Actavis Lab'ys UT, Inc., No. 2021-1924, 2021-2336, 2023 WL 2904757, *4 [65 F.4th 679] (Fed. Cir.
`2023).
`
`Petitioner for the above-referenced petitions for Inter Partes Review (“IPR”) respectfully submits this request for
`Precedential Opinion Panel review of the panel Decisions in these two IPRs denying institution. The two patents are in the
`same family, and Petitioner relied on the same grounds in each petition for the respective challenged claims.
`
`In particular, the Board’s decision is contrary to controlling precedent that “a prior art product that sometimes, but not
`always, embodies a claimed method nonetheless teaches that aspect of the invention,” Hewlett-Packard, 340 F.3d at 1326,
`and that “If the prior art discloses a point within the claimed range, the prior art anticipates the claim,” UCB, 2023 WL
`2904757, *4. Here, the panel erred by applying an inapplicable inherency standard to conclude that a prior art disclosure of
`a dosage that would meet or embody the claimed method for a person of average weight did not anticipate because it did not
`always embody the method for every disclosed dosage for all possible weights.
`
`The pertinent limitation here in the Challenged Claims (claims 17, 19–20, and 22–29 of U.S. Patent No. 8,377,903 B2 and
`claims 36, 38, 39, and 41–48 of U.S. Patent No. 7,713,947 B2) recited “total dose of cladribine reached” during a certain
`period “is about 1.7 mg/kg.” Petitioner’s primary reference (Bodor, US 7,888,328 B2) disclosed, for an equivalent period,
`administering two courses of 5, 6, or 7 tablets of 10 mg each, resulting in a total dose of 100, 110, 120, 130, or 140 mg,
`depending on the exact combination administered, which could be selected based on various factors. A person of ordinary
`skill would recognize 70 kg (about 155 lbs) as an average weight of a patient, which for the 120 mg dosage would be about
`1.71 mg/kg. Other prior art doses are also around 1.71 mg/kg for a person above or below that average (whether due to
`differences in gender, body type, or other), but of course not all doses for weights would result in a dose 1.71 mg/kg. In fact,
`the Examiner performed the exact same exercise during prosecution, using a hypothetical patient weight to demonstrate that
`Bodor taught these limitations. The patent was then allowed to issue because of a misunderstanding that all the claims
`required a lower total dose for a “maintenance period” than for an “induction period,” but the challenged claims here at
`issue did not include that limitation.
`
`Thus, just as in Hewlett-Packard, the method disclosed in Bodor sometimes, but not always, embodies the claimed method.
`Because these instances exist, Bodor anticipates the claims for the same reasoning as Hewlett-Packard. And because the
`prior art discloses a data point in the claimed range (in fact, multiple data points in the claimed range), it is anticipatory as
`explained in UCB.
`
`The Board departed from this controlling precedent, reasoning as follows:
`
`IPR2023-00049
`IPR2023-00050
`Ex. 3001
`
`

`

`
`
`To the extent that Petitioner provides examples to show that under certain very specific circumstances,
`Bodor’s total dose of cladribine could reach an amount that equals about 1.7 mg/kg at the end of a treatment
`period for a particular patient, we do not find that showing persuasive in terms of establishing a reasonable
`likelihood of prevailing on an anticipation challenge. It is apparent to us that Petitioner’s examples involve a
`strategic selection of patient weight and treatment duration that support a calculation that yields a 1.7 mg/kg
`total dosage for the treatment period. We agree with Patent Owner that such a strategy is insufficient to
`establish inherency as it demonstrates only the total dose that is possible for some patients. It is a long-
`standing principle that inherent anticipation requires the missing descriptive element to be “necessarily
`present,” and not merely possibly present. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999).
`
`No. IPR2023-00049, Paper 10, at 13; No. IPR2023-00050, Paper 8, at 13.
`
`The Board’s approach was legal error, contrary to controlling precedent. This case represented no issue of inherency.
`Instead, the prior art here expressly disclosed a dosage point that met the claim limitation for a person of average weight.
`That fact that other dosage points Bodor disclosed, and other weights of individuals, might or might not also meet that claim
`limitation does not matter, because “a prior art product that sometimes, but not always, embodies a claimed method
`nonetheless teaches that aspect of the invention,” Hewlett-Packard, 340 F.3d at 1326.
`
`Because the Board erred as described above, Petitioner respectfully requests the Precedential Opinion Panel review the
`panel decision, grant rehearing, and render a decision instituting inter partes review of the two Challenged Patents.
`
`Respectfully submitted,
`
`/Philip D. Segrest, Jr./
`Reg. No. 39,021
`Lead Counsel for Petitioner
`
`
`
`
`
`A. Lauren Hitchens​​​​
`(she/her/hers)
`Senior Paralegal
`
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