`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`STEADYMED LTD.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner.
`
`
`
`Case IPR2016-00006
`
`Patent No. 8,497,393
`
`____________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`
`
`EXHIBIT DESCRIPTION
`
`TABLE OF EXHIBITS
`
`ABBREVIATION
`
`1001
`
`U.S. Patent No. 8,497,393 to Batra, et al.
`
`'393 Patent
`
`1002 - 1
`
`1002 - 2
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`Prosecution History of U.S. Patent No.
`8,242,305 (excerpts)
`
`Prosecution History of U.S. Patent No.
`8,497,393
`
`U.S. Patent No. 6,765,117 to Moriarty, et al.
`
`J. Org. Chem. 2004, 1890-1902 by Moriarty,
`et al.
`
`International Publication No. WO
`2005/007081 to Phares, et al.
`
`Japanese Patent App. No. 56-122328A to
`Kawakami, et al. (Japanese)
`
`Certified English translation of Japanese
`Patent App. No. 56-122328A to Kawakami, et
`al.
`
`Ege, S. (1989). Organic Chemistry Second
`Edition (pp. 543-547)
`
`Declaration of Jeffrey D. Winkler, Ph.D.
`
`--
`
`--
`
`'117 Patent
`
`Moriarty
`
`Phares
`
`Kawakami
`
`Kawakami
`
`Ege
`
`Winkler Decl.
`
`Curriculum Vitae of Jeffrey D. Winkler, Ph.D.
`
`Affidavit of Boris Levine certifying
`Translation of Japanese Patent App. No. 56-
`122328A to Kawakami, et al.
`
`
`--
`
`--
`
`
`
`
`
`EXHIBIT DESCRIPTION
`
`ABBREVIATION
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`Wiberg, Kenneth (1960), Laboratory
`Technique in Organic Chemistry (p. 112)
`
`U.S. Patent No. 6,441,245 to Moriarty, et al.
`
`Schoffstall, "Microscale and Miniscale
`Organic Chemistry Laboratory Experiments,"
`200-202 (2d ed.) (2004)
`
`U.S. Patent No. 3,703,544 to Morozowich, et
`al.
`U.S. Patent No. 3,888,916 to Sinkula, et al.
`
`“Getting Started in HPLC,” Section 4D:
`Precision and Accuracy, available at
`http://www.lcresources.com/resources/getstart/
`4d01.htm (accessed Sept. 29, 2015)
`
`Gilbert, “Experimental Organic Chemistry: A
`Miniscule and Microscale Approach,” 113-
`117 (5th. ed.) (2011)
`Declaration of James Dowdle Under 37 C.F.R.
`§ 42.63(B)
`Declaration of Boris Levine 37 C.F.R. §
`42.63(B)
`Spreadsheet of 46 batches from Exs. 2053 and
`2036
`
`Dr. Robin D. Rogers Declaration
`
`Dr. Robin D. Rogers CV
`
`Stephen R. Byrn et al., Solid-State Chemistry
`of Drugs, Chapter 10, "Polymorphs," 143-231
`(2d ed. 1999)
`Terence L. Threlfall, "Analysis of Organic
`Polymorphs: A Review," Analyst 120(10):
`
`
`
`Wiberg
`
`'245 Patent
`
`Schoffstall
`
`'544 Patent
`
`'916 Patent
`
`--
`
`Gilbert
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`EXHIBIT DESCRIPTION
`
`ABBREVIATION
`
`1026
`
`1027
`
`1028
`
`2435 (1995
`ANDAs: Pharmaceutical Solid Polymorphism-
`-Chemistry, Manufacturing, and Controls
`Information
`Solid-State Chemistry of Drugs, Chapter 5,
`"Thermal Methods of Analysis," 81-901 (2d
`ed. 1999)
`Drawings made of the compound in the
`Kawakami reference
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Date: September 27, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D. Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`Respectfully submitted,
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
` Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the attached Updated Exhibit List
`
`were served via electronic mail to the following:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`UT393-IPR@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`
`
`Date: September 27, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`WEST\271968305.1
`
`Respectfully submitted,
`
`
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
` Reg. No. 38,347
`DLA Piper LLP (US)
`
`1
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