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Paper _____
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`Patent Owner
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`
`
`
`
`Patent Owner’s Exhibit List as of May 31, 2016
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4825-0169-9884.1
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
`
`
`
`Ex #
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
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`2007
`
`2008
`
`2009
`
`2010
`
`2011
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`2012
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`2013
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`2014
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`2015
`
`Exhibit Description
`
`November 19, 2015 Conference Call Before the Panel
`
`Remodulin Label
`
`FDA Approval Letter
`
`Process Validation Report: (Protocol No.: “VAL 00131”)
`
`Process Optimization Report
`
`UTC Letter of January 2009 to FDA
`
`U.S. Patent No. 8,242,305; the ’305 patent;
`
`U.S. Provisional Patent Application No. 61/014,232
`
`U.S. Patent No. 8,748,657; the ’657 patent
`
`The ’657 patent prosecution history
`
`Zumdahl, Chemistry, pp. A25, A36 (1986)
`
`Brown, et al., Chemistry: The Central Science, pp. G-2, G-10 (9th ed.
`
`2003)
`
`Trial testimony of Dr. Williams and Dr. Aristoff
`
`Suchocki, et al., Conceptual Chemistry, p. G-6 (2001)
`
`U.S. Patent No. 4,668,814; the ’814 patent
`
`4825-0169-9884.1
`
`2
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
`
`UTC Form 10K 2014 Annual Report
`
`Declaration of Liang Gou, Ph.D.
`
`Declaration of Rex Mauthe
`
`May 10, 2016 Conference Call Before the Panel
`
`2016
`
`2017
`
`2018
`
`2019
`
`
`
`Respectfully submitted,
`
`Date: May 31, 2016
`
`
`
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`
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`
`
`
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
`
`
`
`
`
`
`
`
`4825-0169-9884.1
`
`3
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Attorney Docket No. 080618-1601
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Exhibit List and a copy of Exhibit No. 2019 were served on counsel of
`
`record for the Petitioner on May 31, 2016 by delivering a copy via email to Stuart
`
`Pollack and Lisa Haile (the counsel of record for the Petitioner) at the following
`
`
`
`
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`
`Registration No. 35,264
`
`Counsel for Patent Owner
`
`
`
`address: Steadymed-IPR@dlapiper.com.
`
`
`
`
`
`
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`
`
`Date: May. 31, 2016
`
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`4825-0169-9884.1

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