UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`FLATWING PHARMACEUTICALS, LLC and
`MYLAN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ANACOR PHAMACEUTICALS, INC.,
`Patent Owner.
`__________________
`
`Case No. IPR2018-001681
`U.S. Patent No. 9,549,938
`__________________
`
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`1 Case No. IPR2018-01358 has been joined with this proceeding
`
`
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`FLATWING PHARMACEUTICALS, LLC and
`MYLAN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ANACOR PHAMACEUTICALS, INC.,
`Patent Owner.
`__________________
`
`Case No. IPR2018-001681
`U.S. Patent No. 9,549,938
`__________________
`
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`1 Case No. IPR2018-01358 has been joined with this proceeding
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64, Patent Owner Anacor Pharmaceuticals, Inc.
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`
`(“Anacor”) moves to exclude Exhibit 1048 filed by Petitioner FlatWing
`
`Pharmaceuticals, LLC (“FlatWing”). Exhibit 1048 is the Declaration of
`
`Narasimha Murthy, Ph.D. in Support of Petitioner’s Reply to Patent Owner’s
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`Reponse (“Murthy Reply Decl.”). This motion preserves Anacor’s objections to
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`Dr. Murthy’s reply declaration in Paper No. 20.
`
`Dr. Murthy’s reply declaration should be excluded as exceeding the proper
`
`scope of reply evidence. “A reply may only respond to arguments raised in the . . .
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`patent owner’s response,” 37 C.F.R. § 42.23(b), and “[r]eply evidence . . . must be
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`responsive and not merely new evidence that could have been presented earlier,”
`
`The Scotts Co. v. Encap, LLC, IPR2013-00110, Paper No. 37 at 2 (P.T.A.B. Dec.
`
`11, 2013). These limits safeguard “the requirement that the initial petition identify
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`‘with particularity’ the ‘evidence that supports the grounds for the challenge to
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`each claim” in an inter partes review. Intelligent Bio-Systems, Inc. v. Illumina
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`Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Reply evidence that
`
`exceeds these limits is properly excluded in its entirety because “neither [the
`
`Federal Circuit] nor the Board must parse the reply [evidence] to determine which,
`
`if any parts . . . are responsive and which are improper.” Id; see also Office Patent
`
`Trial Practice Guide, 77 Fed. Reg. 48,756, (Aug. 14, 2012) (“[I]ndications that a
`
`new issue has been raised in a reply include new evidence necessary to make out a
`
`2
`
`
`
`
`prima facie case [of] patentability or unpatentability . . . and new evidence that
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`could have been presented in a prior filing.”).
`
`FlatWing’s petition cited Samour (Ex. 1010) in combination with Austin
`
`(Ex. 1007) and Brehove (Ex. 1008) or Freeman (Ex. 1009) to establish the
`
`obviousness of claims 3, 5, and 6 of U.S. Patent No. 9,549,938 (“the ’938 patent”).
`
`Claims 3, 5, and 6 recite “a solution comprising 5% w/w of [tavaborole].” In
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`response to Anacor’s evidence that the cited art teaches away from 5% w/w,
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`FlatWing and Dr. Murthy have pivoted away from relying on Samour in favor of
`
`emphasizing overlapping ranges disclosed in the remaining references and arguing
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`that a person of ordinary skill in the art (“POSA”) would have arrived at 5% w/w
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`through “routine” dose-ranging studies.
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`In pivoting away from Samour, Dr. Murthy newly opines, based on the
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`overlapping ranges in the cited art, that “it would have been obvious to a POSA . . .
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`to try the 5% solution in routine dose ranging studies” or that the ranges “provid[e]
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`a reasonable expectation of success in including the 5% solution in a routine dose
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`ranging study.” See Murthy Reply Decl. (Ex. 1048) ¶¶ 2–5, 10, and 12. Despite
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`acknowledging the overlapping ranges in his opening declaration, Dr. Murthy did
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`not offer any of these opinions at that time, nor do these opinions respond to the
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`opinions or analyses of Anacor’s experts, specifically Dr. Lane’s teaching-away
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`analysis or Dr. Reider’s analysis of whether it would have been routine to perform
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`3
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`
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`dose-ranging studies with boron-containing compounds such as tavaborole. These
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`opinions are also a departure from Dr. Murthy’s original rationale that “a POSA
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`would be motivated to substitute [tavaborole] . . . for the higher molecular weight
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`compound disclosed in the Samour formulation to arrive at” the claimed invention.
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`Murthy Decl. (Ex. 1005) ¶ 136; see also id. ¶ 138. Dr. Murthy’s new “obvious . . .
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`to try” opinion is also completely out of left field as FlatWing’s petition does not
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`rely on an obvious-to-try rationale with respect to the 5% w/w limitation. Dr.
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`Murthy’s new opinions exceed the scope of proper reply evidence.
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`Additionally Dr. Murthy’s new opinions concerning Anacor’s dose-ranging
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`studies in Exhibit 1040 are untimely as Exhibit 1040 was known to FlatWing at the
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`time it filed its petition. See Murthy Reply Decl. (Ex. 1048) ¶¶ 17–19. Exhibit
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`1040 was filed as an exhibit in IPR2018-00170 on November 21, 2017, and was in
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`fact considered by Dr. Murthy to address limitations concerning tavaborole’s
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`mechanism of action in U.S. Patent No. 9,566,290. FlatWing and Dr. Murthy’s
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`belated analysis of Exhibit 1040 in support of their conclusory assertion that dose-
`
`ranging studies are “routine” is improper supplementation of FlatWing’s petition
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`for inter partes review, and is yet another reason why Dr. Murthy’s reply
`
`declaration should be excluded.
`
`4
`
`
`
`
`
`CONCLUSION
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`For the foregoing reasons, Anacor respectfully requests that the Board
`
`exclude Dr. Murthy’s reply declaration, Exhibit 1048.
`
`
`Date: January 25, 2019
`
`
`
`
`
`
`
` Respectfully submitted,
`
`/s/ Aaron P. Maurer
`Aaron P. Maurer (Reg. No. 44,911)
`David I. Berl (Reg. No. 72,751)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`amaurer@wc.com
`dberl@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`
`5
`
`
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that a true and correct copy of the
`
`
`
`
`
`foregoing was served on January 25, 2019, by delivering a copy via electronic mail
`
`on the following attorneys of record for Petitioners:
`
`Philip D. Segrest, Jr.
`Eric J. Rakestraw
`Edward D. Manzo
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, Illinois 60606
`Philip.Segrest@HuschBlackwell.com
`Eric.Rakestraw@HuschBlackwell.com
`PTAB-ERakestraw@HuschBlackwell.com
`Edward.Manzo@HuschBlackwell.com
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`
`
`
`
`
`
`
`
`/Anthony H. Sheh/
`Anthony H. Sheh
`Reg. No. 70,576
`
`
`
`
`6
`
`
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