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Trials@uspto.gov
`571-272-7822
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`
`
`
`
`
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` Paper No. 25
`
`
` Entered: May 11, 2016
`
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`STEADYMED LTD.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00006
`Patent 8,497,393 B2
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`DECISION
`Petitioner’s Motion for Supplemental Information
`37 C.F.R. § 42.123(a)
`
`
`
`
`
`
`

`

`IPR2016-00006
`Patent 8,497,393 B2
`
`
`
`On May 10, 2016 a conference call was conducted among counsel for
`Petitioner, SteadyMed LTD (“SteadyMed”), counsel for Patent Owner,
`United Therapeutics Corporation (“UTC”), and Judges Green, Chang, and
`Harlow. During that call, SteadyMed requested authorization to file a
`motion to submit supplemental information, in the form of two declarations,
`attesting to the accuracy of the English translation of Japanese Patent
`Application No. JP 56-122328A, published September 25, 1981
`(“Kawakami”) (Ex. 1006). UTC indicated in response that it opposed
`neither SteadyMed’s request for authorization to file the motion to submit
`supplemental information, nor the motion itself. We authorized SteadyMed
`to file a motion to submit supplemental information pursuant to 37 C.F.R.
`§ 42.123 during the conference call, and memorialized that authorization in a
`written order (Paper 24). SteadyMed filed the instant motion to submit
`supplemental information on May 11, 2016 (Paper 23).
`As the moving party, SteadyMed bears the burden of proving that it is
`entitled to the requested relief. 37 C.F.R. § 42.20(c). Under 37 C.F.R.
`§ 42.123(a), a party may file a motion to submit supplemental information if
`the following requirements are met: (1) a request for authorization to file
`such motion is made within one month of the date the trial was instituted;
`and (2) the supplemental information must be relevant to a claim for which
`trial has been instituted.
`SteadyMed sought authorization to file its motion via correspondence
`dated May 6, 2016, which is within one month of the institution date in this
`proceeding of April 8, 2016 (Paper 12). In addition, the supplemental
`
`2
`
`

`

`IPR2016-00006
`Patent 8,497,393 B2
`
`
`information SteadyMed seeks to submit is relevant to the patentability of
`claims 6, 10, 15, 21, and 22, on which trial has been instituted under
`§ 103(a) in view of Moriarty, Phares, Kawakami, and Eğe (Paper 12).
`Specifically, the declarations of Mr. Boris Levine (Ex. 1019), and Mr. James
`Dowdle (Ex. 1020) that SteadyMed wishes to submit allegedly confirm that
`Ex. 1007 is an accurate translation of Kawakami, and are, therefore, relevant
`to the patentability of claims 6, 10, 15, 21, and 22 in view of Moriarty,
`Phares, Kawakami, and Eğe. See Taiwan Semiconductor v. DSS Technology
`Management, Inc., Case IPR No. 2014-01030, slip op. at 3 (PTAB Feb. 3,
`2015) (Paper 11) (granting motion to submit supplemental information
`regarding accuracy of translation of Japanese prior art reference).
`We also are persuaded that SteadyMed has met its burden because the
`supplemental information SteadyMed seeks to submit does not change the
`grounds of unpatentability authorized in this proceeding, nor does it change
`the evidence initially presented in the Petition to support those grounds of
`unpatentability. Rather, the proffered declarations constitute additional
`evidence that allegedly confirms the accuracy of the English translation of
`Kawakami, as presented in Exhibit 1007. See id.
`
`Accordingly, it is
`ORDERED that SteadyMed’s motion to submit Exhibits 1019 and
`1020 as supplemental information under 37 C.F.R. § 42.123(a) is granted.
`
`
`
`3
`
`

`

`IPR2016-00006
`Patent 8,497,393 B2
`
`
`PETITIONER:
`Stuart E. Pollack
`Lisa A. Haile
`DLA Piper LLP
`Steadymed-IPR@dlapiper.com
`
`
`
`PATENT OWNER:
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`ut393-ipr@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ut393-ipr@foley.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`ut393-ipr@foley.com
`
`
`4
`
`

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