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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`LIQUIDIA TECHNOLOGIES, INC.,
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`Petitioner,
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`v.
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`UNITED THERAPEUTICS CORPORATION,
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`Patent Owner.
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`_______________
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`Case IPR2021-00406
`Patent 10,716,793
`_______________
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`PATENT OWNER’S IDENTIFICATION OF PORTIONS OF
`PETITIONER’S REPLY TO WHICH IDENTIFIED SUR-REPLY
`EVIDENCE AND ARGUMENTS ARE RESPONSIVE
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`4865-9072-1052
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`
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`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`Patent Owner’s Identification of Reply
`Arguments to which Identified Sur-
`Reply Evidence Is Responsive
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`Pursuant to the Board’s emails dated March 24 and 25, 2022, Patent Owner
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`hereby identifies portions of Petitioner’s Reply to which the exhibits and
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`arguments objected to by Petitioner in Paper No. 60 are responsive.
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`1) Ex. 2092 (as attached to Ex. 2094 at 63-65); Ex. 2094, 20:22-24:7
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`(discussing Ex. 2092); and Sur-Reply at 8-9 (relying on the portions of Ex. 2094
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`related to Ex. 2092), are responsive to at least:
`o Petitioner’s Reply, pages 5-6 (regarding Petitioner’s argument that the
`JESC Supplement was publicly accessible to a POSA);
`o Petitioner’s Reply, pages 8-9 (regarding Petitioner’s argument that the
`JAHA Supplement was publicly accessible to a POSA);
`o Petitioner’s Expert’s Reply Declaration (Hall-Ellis), EX1112 at ¶50
`(regarding JAHA Supplement), and ¶85 (regarding JESC Supplement).
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`See Sur-Reply (Paper No. 55) at 7-9.
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`2) Ex. 2093 (as attached to Ex. 2094 at 66-77); Ex. 2094, 32:11-36:18
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`(discussing Ex. 2093); and Sur-Reply at 10-11 (relying on the portions of Ex.
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`2094 related to Ex. 2093), are responsive to at least:
`o Petitioner’s Reply, page 7 (regarding Petitioner’s argument that the
`Sulica authors were able to access the JAHA Abstract/Supplement);
`o Petitioner’s Expert’s Reply Declaration (Hall-Ellis), EX1112 at ¶62
`(page 38) (regarding testimony that the Sulica article shows that the
`Voswinckel JAHA Abstract can be found by a POSA).
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`See Sur-Reply (Paper No. 55) at 10-11.
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`4865-9072-1052
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`IPR2021-00406
`U.S. Patent No. 10,716,793
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`Patent Owner’s Identification of Reply
`Arguments to which Identified Sur-
`Reply Evidence Is Responsive
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`3) Ex. 2100 (referred to as Tab 6 in Ex. 2099); Ex. 2101 (Tab 5 in Ex. 2099);
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`Ex. 2102 (Tab 9 in Ex. 2099); Ex. 2103 (Tab 4 in Ex. 2099); Ex. 2099, 163:23-
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`176:5, 180:20-185:10, 198:8-201:6, 201:18-203:9 (discussing Ex. 2100-2103); and
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`Sur-Reply at a) P.14: “EX2102, 27 (DeVilbiss manual: output rates of 3.0 and 2.5
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`mL/min)”; b) P.14: “EX2100, 28; EX2101, 28 (Multisonic manual: rates of 0.6 and
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`0.5 mL/min)”; c) P.16: “But if the” to “EX2100, 28”; and d) P.16: “Lieberman
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`2006” to “respectively” are responsive to at least the following portions of
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`Petitioner’s Reply and the exhibits cited therein:
`o Pages 11-12, including n.8 (e.g., regarding arguments relating to a
`50% efficiency loss, that jet nebulizer art is “inapposite,” that there is a
`“typical” nebulization rate, relying on EX1037 for a rate of 0.6 mL/min,
`and identifying asserted nebulizer rates);
`o Pages 12-13, including their reliance on EX1107, ¶¶22-27 (e.g.,
`regarding argument that “‘patient factors,’ gas and flow pressure, fill and
`dead volumes, gas density, humidity and temperature conditions,
`breathing pattern, and device interface” do not affect dosage delivery
`because “device[s] account[] for these factors and produce consistent
`delivery dosage”); see also EX1107, ¶¶22-23 (stating “the only ultrasonic
`nebulizer cited by Professor McConville had an efficiency of 86%” and
`relying on Gessler to imply ultrasonic nebulizers all have “higher
`efficiency”), ¶24 (alleging a “known nebulization rate of 0.6 mL/min,”
`“assuming that 50% of the output may be lost,” and “the output is the
`amount arriving at the mouthpiece”), ¶25 (arguing “POSA would have
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`IPR2021-00406
`U.S. Patent No. 10,716,793
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`Patent Owner’s Identification of Reply
`Arguments to which Identified Sur-
`Reply Evidence Is Responsive
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`reasonably assumed the OptiNeb device was employed in Voswinckel
`JESC,” relevant to at least EX2099 at 171:4-172:11 and 173:19-174:9,
`and relying on EX1037 and reported rates from EX1097-1099), ¶26
`(“assum[ing] that the values in the literature are applicable to estimate the
`range of doses delivered in [JESC]”); ¶27 (arguing nebulizer efficiency
`factors are “taken into account” and relying on EX1062).
`o Pages 13-14 (e.g., “Any ‘delivery efficienc[y] … ’ differences
`between continuous and pulsed nebulizers are irrelevant,” and asserting
`that there are “standard nebulizers”);
`o Page 14 (e.g., “multiple milliliters of solution would have been
`delivered to and inhaled by the patient”);
`o Page 15, including n.10 (e.g., “a POSA would reasonably have
`understood the authors to be referring to use of the particular device
`disclosed in the manual” and “A POSA would expect device design
`choices like baffle plates or operation frequency to not make a
`meaningful difference in delivery amount and to be accounted for in the
`manual’s reported 0.6[ ]mL/min delivery rate”);
`o Pages 10, 12, 14 (e.g., citing Petitioner’s Expert’s Reply Declaration
`(Gonda), EX1107, ¶¶18-21, 47-50 (regarding expert’s testimony on
`“typical values of output of ultrasonic nebulizers used prior to May 15,
`2006”)).
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`See Sur-Reply (Paper No. 55) at 13-16.
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`Date: April 14, 2022
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`Respectfully submitted,
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`/Stephen B. Maebius/
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`4865-9072-1052
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`IPR2021-00406
`U.S. Patent No. 10,716,793
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`Patent Owner’s Identification of Reply
`Arguments to which Identified Sur-
`Reply Evidence Is Responsive
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`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`4865-9072-1052
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`4
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`IPR2021-00406
`U.S. Patent No. 10,716,793
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`Patent Owner’s Identification of Reply
`Arguments to which Identified Sur-
`Reply Evidence Is Responsive
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Patent
`Owner’s Identification of Portions of Petitioner’s Reply To Which Identified Sur-
`Reply Evidence And Arguments Are Responsive was served on counsel of record
`on April 14, 2022, by filing this document through the PTAB E2E System as well
`as delivering a copy via email to the counsel of record for the Petitioner at the
`following address:
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`zLiquidiaIPR@cooley.com
`ielrifi@cooley.com
`emilch@cooley.com
`dkannappan@cooley.com
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`Date: April 14, 2022
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4865-9072-1052
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`5
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