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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`STEADYMED LTD.,
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`Petitioner,
`
`v.
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`UNITED THERAPEUTICS CORPORATION
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`Patent Owner.
`
`
`
`Case IPR2016-00006
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`Patent No. 8,497,393
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`____________
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`PETITIONER'S RESPONSIVE LIST PURSUANT TO BOARD'S ORDER
`(PAPER NO. 56)
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`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`WEST\273802943.3
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`
`
`
`
`
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`Pursuant to Paper No. 56, Petitioner SteadyMed Ltd. ("Petitioner") submits
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`its responsive itemized list:
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`(1) Portions that Respond to Patent Owner's Arguments Regarding
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`Melting Point of Polymorphs, Including Form A and Form B:
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`a) Rogers Declaration (Ex. 1022), p. 21, line 4 from the end of the page
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`through p. 24, last line: See Patent Owner Response, at 22-24;
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`Williams Declaration (Ex. 2020), at ¶ ¶ 72-78; see also Exs. 2030 and
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`2031. For example:
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`"It is known in the art that sample size, rate of heating,
`the recrystallization solvent(s) used, and the conditions
`under which the crystalline sample was obtained can
`significantly affect
`the DSC data. Dr. Winkler's
`conclusion based on this single vague and incompletely
`described DSC data is not scientifically sound."
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`Williams Declaration, Ex. 2020, at ¶ 76; Patent Owner Response at 24.
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`b) Rogers Declaration (Ex. 1022), p. 29, first line through p. 30, line 4:
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`See Response to (a), above.
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`
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`1
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`
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`(2) Portions that Teach the Meaning and Provide Background to the
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`Scientific Terminology Used in Dr. Rogers' Opinion:
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`a) Petitioner's Reply, p. 13, line 8: See Petitioner's Reply at 14-15. For
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`example:
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`"By contrast, Dr. Rogers' Declaration cites several
`literature sources explaining that melting point uniquely
`identifies a polymorph. (Ex. 1022, ¶¶ 49-52). Thus, for
`the same polymorph, if the melting point differs, it is due
`to impurities contained in the sample having a lower
`melting point. (Id., ¶ 64.) Dr. Rogers concludes that
`Phares' higher melting point is necessarily due to higher
`or at least identical purity. (Id., ¶ 74.). Moreover, the
`width of the DSC peak in the Phares reference is very
`narrow, consistent with a very pure material. (Id., ¶ 84.)."
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`Petitioner's Reply at 15.
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`b) Rogers Declaration (Ex. 1022), p. 9, line 8 through p. 24, last line: See
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`Petitioner's Reply at 14-15, Exs. 1001 ('393 Patent) and 1005 (Phares
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`prior art reference); see also Petition, at 27-28, and 55. Patent Owner
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`elected not to depose Dr. Rogers.
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`c) Rogers Declaration (Ex. 1022), p. 26, line 7 from the end of the page
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`through p. 30, line 4: See Response to (b), above, and Ex. 1027.
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`
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`2
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`
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`d) Rogers Declaration (Ex. 1022), p. 30, line 11 (beginning of Section
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`VIII.A.) through p. 34, line 6 from the end of the page: See
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`Petitioner's Reply at 15: "Moreover, the width of the DSC peak in the
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`Phares reference is very narrow, consistent with a very pure material."
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`e) Rogers Declaration (Ex. 1022), p. 35, line 1 through p. 36, last line:
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`See Petitioner's Reply at 15.
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`f) Rogers Declaration (Ex. 1022), p. 37, line 4 through p. 38, last line:
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`See Response to (b), above.
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`(3) Portions Quoting Patent Owner's Expert, and the Board's Statements
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`Prohibiting Introduction of New Evidence
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`Petitioner quotes the October 6, 2016 transcript (Ex. 2060):
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`"MR. MAEBIUS: Well, this listing of the new arguments in
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`petitioner's reply, and the Rogers' declaration, and the instances of
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`mischaracterized testimony from patent owner's expert, will that allow
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`us to get a decision on the question of whether we can address at the
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`final hearing the mischaracterized testimony of Dr. Williams by
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`pointing out other parts of the Williams' deposition transcript?
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`[…]
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`JUDGE HARLOW: Thank you for holding. Just to clarify, the parties
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`will not be permitted to introduce new evidence at the oral hearing.
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`3
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`
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`You will be permitted to point out any alleged mischaracterization and
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`to identify other parts of the transcript if they are of record that might
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`be responsive, but the parties will not be permitted to raise new
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`arguments or present new evidence."
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`(Ex. 2060, at 25:5-26:6) (emphasis added).
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`4
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`
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`Date: October 17, 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)
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`
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`5
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`
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the attached PETITIONER'S
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`RESPONSIVE LIST PURSUANT TO BOARD'S ORDER was served via
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`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: October 17, 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)
`
`
`
`WEST\273802943.3