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UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`PHARMACOSMOS A/S,
`Petitioner,
`v.
`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`
`IPR2015-01490; Patent 7,754,702 B2
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`
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`
`
`PETITIONER’S SUR-REPLY RESPONDING TO PATENT OWNER’S
`REPLY TO OPPOSITION TO MOTION TO AMEND
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`IPR2015-01490
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` Patent 7,754,702 B2
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`
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`
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`Petitioner Pharmacosmos A/S (“Petitioner”) hereby submits its sur-reply to
`
`Patent Owner’s Reply to Opposition to Motion to Amend (Paper 40) (“Reply”)
`
`served on July 19, 2016. Petitioner submits this sur-reply to address an issue that
`
`was raised by Patent Owner for the first time in its Reply, rather than in its original
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`Motion to Amend as it should have been.
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`Patent Owner’s proposed substitute claims contain no limitation that restricts
`
`the species of subject being treated, encompassing “mouse to elephant,” so that the
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`Patent Owner is required to demonstrate the support (enablement) and patentability
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`of the proposed substitute claims over veterinary prior art. Opposition (Paper 34)
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`at 6-7. Patent Owner newly argues that the specification of the ‘702 patent “is
`
`clear that the ‘subject’ is ‘human’” and that a “POSITA would understand that
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`‘subject’ only refers to a human.’” Reply (Paper 40) at 3-5. Petitioner disagrees.
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`Patent Owner’s contention that the use of the term “subject” in the claims
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`necessarily refers to a human is incorrect as a matter of law because it improperly
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`attempts to import a limitation from the specification into the claims. See Novartis
`
`AG v. Mylan Pharms., Inc., No. 09-CV-3604 PGS, 2011 WL 3664401, at *7
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`(D.N.J. Aug. 17, 2011) (“[I]t is important not to import into a claim limitations that
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`are not a part of the claim.” (citation omitted)); see also Liebel-Flarsheim Co. v.
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`Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (“Even when the specification
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`describes only a single embodiment, the claims of the patent will not be read
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`
`
`1
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`

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`IPR2015-01490
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` Patent 7,754,702 B2
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`restrictively unless the patentee has demonstrated a clear intention to limit the
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`claim scope using ‘words or expressions of manifest exclusion or restriction.’”
`
`(quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir.
`
`2002))).
`
`Contrary to the Patent Owner’s contention, the specification of the ‘702
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`patent does not limit the term “subject” to humans, and discloses: “treating a state,
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`disease, disorder, or condition includes preventing or delaying the appearance of
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`clinical symptoms in a mammal that may be afflicted ….” Ex. 1001 at 6:5-10
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`(emphasis added).
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`Therefore, the claim term “subject” is not restricted to humans, should be
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`deemed unenabled, and Patent Owner has not met its burden of proving
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`patentability over the art, which includes veterinary art.
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`
`
`Respectfully submitted,
`
`BAKER BOTTS L.L.P.
`
`
`/s/ Lisa Koie
`
`
`
`ATTORNEYS FOR
`PHARMACOSMOS
`Lisa Kole (PTO Reg. No. 35,225)
`Steven Lendaris (PTO Reg. No. 53,202)
`Paul Ragusa (PTO Reg. No. 38,587)
`Jennifer Tempesta (PTO Reg. No. 59,021)
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`
`
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`
`
`July 29, 2016
`Date
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`2
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`

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`IPR2015-01490
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` Patent 7,754,702 B2
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`New York, NY 10112
`Telephone: (212) 408-2500
`Facsimile: (212) 408-2501
`Email: lisa.kole@bakerbotts.com
`steven.lendaris@bakerbotts.com
`paul.ragusa@bakerbotts.com
`jennifer.tempesta@bakerbotts.com
`
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`3
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`

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`IPR2015-01490
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` Patent 7,754,702 B2
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`CERTIFICATE OF SERVICE ON PATENT OWNER
`UNDER 37 C.F.R. § 42.105(a)
`
`The undersigned hereby certifies that the foregoing PETITIONER’S SUR-
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`REPLY RESPONDING TO PATENT OWNER’S REPLY TO OPPOSITION TO
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`MOTION TO AMEND is being served on July 29, 2016 by filing through the
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`Patent Review Processing System and delivering a copy via email to the counsel
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`for Patent Owner at the addresses of record:
`
`
`
`George E. Quillin
`Michael D. Kaminski
`Foley & Lardner L.L.P
`3000 K Street, N.W., Suite 600
`Washington, D.C. 20007
`Email: gquillin@foley.com
`mkaminski@foley.com
`
`
`
`
`
`Dated: July 29, 2016
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`
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`Respectfully submitted
`
`
`
`
`
`
`
`/s/ Lisa Kole
`
`Lisa Kole (PTO Reg. No. 35,225)
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`New York, NY 10112
`Telephone: (212) 408-2500
`Facsimile: (212) 408-2501
`Email: lisa.kole@bakerbotts.com
`
`4

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