`
`
`By: Jeffrey D. Blake, Esq.
` MERCHANT & GOULD P.C.
`
`191 Peachtree Street N.E., Suite 4300
` Atlanta, GA 30303
`
`jblake@merchantgould.com
` Main Telephone: (404) 954-5100
` Main Facsimile: (404) 954-5099
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`___________________
`
`Case IPR2015-01776 (Patent 7,582,621 B2)
`____________________
`PETITIONER’S RESPONSE TO PATENT OWNER’S MOTION FOR
`OBSERVATIONS REGARDING THE CROSS-EXAMINATION
`TESTIMONY OF STEPHEN B. KAHL, PH.D.
`
`
`
`
`
`
`
`IPR2015-01776
`Patent 7,582,621
`
`I.
`
`INTRODUCTION
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`Pursuant to the Scheduling Order (Paper No. 25), Petitioner hereby submits
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`its Response to Patent Owner’s Motion for Observations Regarding the Cross-
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`Examination Testimony of Stephen B. Kahl, Ph.D. (Paper No. 55.) In accordance
`
`with the Scheduling Order, Petitioner’s response to each of Patent Owner’s
`
`observations is equally concise and specific.
`
`II.
`
`RESPONSE TO OBSERVATIONS
`
`1.
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`Petitioner agrees with Dr. Kahl’s testimony in Ex. 2206 at 66:1-6 that
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`Austin alone furnishes a reasonable expectation of success in view of the
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`knowledge of a person of ordinary skill in the art as well as the limited disclosure
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`of the provisional application (Ex. 1064) to which U.S. Patent No. 7,582,621
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`claims priority. However, Petitioner does not and has not argued that claims 1-12
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`of U.S. Patent No. 7,582,621 are unpatentable under 35 U.S.C. § 102 over Austin
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`alone. (See Paper No. 1 at 8; see Paper No. 24 at 4, 15-16.) It is clear from the
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`Petition and reply brief that Petitioner’s grounds for unpatentability are based on a
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`35 U.S.C. § 103 combination of references. (Paper No. 1 at 8; Paper No. 47 at 1.)
`
`2.
`
`In Ex. 2206 at 67:1-25 and 70:19-71:12, Dr. Kahl testified that he
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`reviewed and relied on Ex. 1028, titled “Drug delivery to the nail following topical
`
`application,” while preparing his declaration in support of Petitioner’s reply and
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`that earlier in his deposition he did not recall that he looked at Ex. 1028 because it
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`1
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`IPR2015-01776
`Patents 7,582,621
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`was among the “large number of materials” he had to review. In Ex. 2206 at 61:14-
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`17 and 62:14-17, Dr. Kahl testified that Ex. 1028, which discloses drug delivery to
`
`the nail, “is rather outside my area of expertise.” In rebuttal to Patent Owner’s
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`expert Dr. Reider, Dr. Kahl’s declaration addresses the well-accepted more general
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`principle that “topical formulations for delivery of a compound significantly
`
`reduce concerns related to systemic toxicity.” (Ex. 1043 at ¶ 23; Ex. 2033 (Dr.
`
`Kahl’s First Deposition Testimony) at 406:7-408:20 (“the plasma concentrations of
`
`topically administered agents are typically orders of magnitude less than what they
`
`would be if that drug were administered orally”); see also Paper No. 32 at 62 (“[a]s
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`one professor stated, ‘[t]opical therapy avoids the problems associated with the
`
`adverse events and drug interactions of systemic drugs and may have greater
`
`patient compliance.’”); Ex. 2041 at 24.)
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`IPR2015-01776
`Patents 7,582,621
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`Date: October 11, 2016
`
`
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`
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`Respectfully submitted,
`
`MERCHANT & GOULD, P.C.
`
`Respectfully submitted,
`
`
`
`
`
`By:
`Jeffrey D. Blake, Esq. Reg. No. 58,884
`Kathleen E. Ott, Esq. Reg. No. 64,038
`Peter A. Gergely, Esq. (Pro Hac Vice)
`Ryan J. Fletcher, Esq., Ph.D. (Pro Hac Vice)
`Brent E. Routman, Esq. (Pro Hac Vice)
`Merchant & Gould P.C.
`191 Peachtree Street N.E., Suite 4300
`Atlanta, GA 30303
`Main Telephone: (404) 954-5100
`Main Facsimile: (404) 954-5099
`
`Counsel for Petitioner
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`3
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`IPR2015-01776
`Patents 7,582,621
`
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`CERTIFICATE OF SERVICE ON PATENT OWNER
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on October 11,
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`2016, a complete and entire copy of PETITIONER’S RESPONSE TO PATENT
`
`OWNER’S MOTION FOR OBSERVATIONS REGARDING THE CROSS-
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`EXAMINATION TESTIMONY OF STEPHEN B. KAHL, PH.D. was served by
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`Respectfully submitted,
`
`
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`MERCHANT & GOULD P.C.
`
`
`
`
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`By:
` Counsel for Petitioner
`
`
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`4
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`email, by agreement of the parties to:
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`areister@cov.com; and
`elongton@cov.com.
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