UNITED STTES PATENT AND TRADEMARK OFFICE
`
`____________
`
`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 RESPONSIVE LIST PURSUANT TO BOARD'S ORDER
`(PAPER NO. 56)
`
`
`
`
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`WEST\273802943.3
`
`
`
`
`
`
`
`____________
`
`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 RESPONSIVE LIST PURSUANT TO BOARD'S ORDER
`(PAPER NO. 56)
`
`
`
`
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`WEST\273802943.3
`
`
`
`
`
`
`
`Pursuant to Paper No. 56, Petitioner SteadyMed Ltd. ("Petitioner") submits
`
`its responsive itemized list:
`
`(1) Portions that Respond to Patent Owner's Arguments Regarding
`
`Melting Point of Polymorphs, Including Form A and Form B:
`
`a) Rogers Declaration (Ex. 1022), p. 21, line 4 from the end of the page
`
`through p. 24, last line: See Patent Owner Response, at 22-24;
`
`Williams Declaration (Ex. 2020), at ¶ ¶ 72-78; see also Exs. 2030 and
`
`2031. For example:
`
`"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."
`
`Williams Declaration, Ex. 2020, at ¶ 76; Patent Owner Response at 24.
`
`b) Rogers Declaration (Ex. 1022), p. 29, first line through p. 30, line 4:
`
`See Response to (a), above.
`
`
`
`1
`
`
`
`(2) Portions that Teach the Meaning and Provide Background to the
`
`Scientific Terminology Used in Dr. Rogers' Opinion:
`
`a) Petitioner's Reply, p. 13, line 8: See Petitioner's Reply at 14-15. For
`
`example:
`
`"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.)."
`
`Petitioner's Reply at 15.
`
`b) Rogers Declaration (Ex. 1022), p. 9, line 8 through p. 24, last line: See
`
`Petitioner's Reply at 14-15, Exs. 1001 ('393 Patent) and 1005 (Phares
`
`prior art reference); see also Petition, at 27-28, and 55. Patent Owner
`
`elected not to depose Dr. Rogers.
`
`c) Rogers Declaration (Ex. 1022), p. 26, line 7 from the end of the page
`
`through p. 30, line 4: See Response to (b), above, and Ex. 1027.
`
`
`
`2
`
`
`
`d) Rogers Declaration (Ex. 1022), p. 30, line 11 (beginning of Section
`
`VIII.A.) through p. 34, line 6 from the end of the page: See
`
`Petitioner's Reply at 15: "Moreover, the width of the DSC peak in the
`
`Phares reference is very narrow, consistent with a very pure material."
`
`e) Rogers Declaration (Ex. 1022), p. 35, line 1 through p. 36, last line:
`
`See Petitioner's Reply at 15.
`
`f) Rogers Declaration (Ex. 1022), p. 37, line 4 through p. 38, last line:
`
`See Response to (b), above.
`
`(3) Portions Quoting Patent Owner's Expert, and the Board's Statements
`
`Prohibiting Introduction of New Evidence
`
`Petitioner quotes the October 6, 2016 transcript (Ex. 2060):
`
`"MR. MAEBIUS: Well, this listing of the new arguments in
`
`petitioner's reply, and the Rogers' declaration, and the instances of
`
`mischaracterized testimony from patent owner's expert, will that allow
`
`us to get a decision on the question of whether we can address at the
`
`final hearing the mischaracterized testimony of Dr. Williams by
`
`pointing out other parts of the Williams' deposition transcript?
`
`[…]
`
`JUDGE HARLOW: Thank you for holding. Just to clarify, the parties
`
`will not be permitted to introduce new evidence at the oral hearing.
`
`
`
`3
`
`
`
`You will be permitted to point out any alleged mischaracterization and
`
`to identify other parts of the transcript if they are of record that might
`
`be responsive, but the parties will not be permitted to raise new
`
`arguments or present new evidence."
`
`(Ex. 2060, at 25:5-26:6) (emphasis added).
`
`
`
`
`
`4
`
`
`
`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)
`
`
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the attached PETITIONER'S
`
`RESPONSIVE LIST PURSUANT TO BOARD'S ORDER was 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: 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
`
`
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