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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.
`
`
`Case IPR2021-00406
`Patent 10,716,793
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`PETITIONER’S OBSERVATIONS ON THE
`CROSS-EXAMINATION OF DR. HILL
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`IPR2021-00406
`Patent 10,716,793 B2
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`Petitioner’s Observations on the
`Cross-Examination of Dr. Hill
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`Petitioner files these observations on the 4/13/2022 deposition of Dr. Hill
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`pursuant to the Board’s Order authorizing both parties to file observations “no later
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`than two business days after the conclusion of the deposition.” (Paper 53, 4.)
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`1. Observation #1: Voswinckel JESC and JAHA abstracts would have
`been accessible by conference attendees. (Relevant to public accessibility)
`In anticipated Exhibit 2108 (4/13/22 Hill Deposition Transcript) at 20:3-15,
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`Dr. Hill testified that in his experience attending conferences like the European
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`Society of Cardiology Congress and American Heart Association’s Scientific
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`Sessions, at which Voswinckel JESC and JAHA were respectively presented, the
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`conferences “compile . . . abstract issues that are generally disseminated as a
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`supplement to the journal to the subscribers and also are available at the meeting
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`site.” Id. He explains that his declaration statements and testimony about the public
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`availability of Voswinckel JESC and JAHA “is consistent with [his] experience in
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`attending these meetings. This is how these abstracts are handled.” Id.
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`2. Observation #2: A POSA would have expected the Voswinckel JESC
`authors to be using an efficient nebulizer with the typical or above
`average rate of delivery, not less than 0.3mL/min. (Relevant to Ground 1
`and 2: Voswinckel JESC’s disclosure of a 15-90µg dose)
`In anticipated Exhibit 2108 at 22:3-23:7, Dr. Hill testified that in his clinical
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`experience, the average nebulization rate for continuous nebulizers in the 2006 time
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`frame was 0.5 to 0.6 mL/min. In anticipated Exhibit 2108 at 29:17-31:10, Dr. Hill
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`explains that even if the OptiNeb device used in Voswinckel has a “range that could
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`IPR2021-00406
`Patent 10,716,793 B2
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`be delivered” (i.e., if it could have delivered < 0.6mL/min), in “[his] experience
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`Petitioner’s Observations on the
`Cross-Examination of Dr. Hill
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`using continuous nebulizers, . . it would be extremely unusual to go to a dose less
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`than around 0.3[mL/min] because there has to be a certain volume to generate a mist
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`that the patient can then inhale[.]” In anticipated Exhibit 2108 at 45:17-46:8 and
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`47:7-20, Dr. Hill further testified that though “there is a wide range . . . in terms of
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`efficiency between nebulizers,” a POSA would have understood the Voswinckel
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`JESC authors to have been “concerned about accurately dosing patients for the
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`purposes of a study” and seen that the authors selected from a “line of nebulizers
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`[that] are generally much more accurate in terms of the rate of delivery of aerosol
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`to a patient, and accordingly, they would be at the higher range of efficiency[.]”
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`Additionally, Dr. Hill testified that “as a POSA with experience using nebulizers, …
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`[he] know[s] it would be important for authors of a study like this to select a device
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`that they could rely on to deliver a reliable dose at a reliable delivery rate.” Id.
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`3. Observation #3: Geller (Ex. 1034) demonstrated feasibility, tolerability,
`and association with improvement in pulmonary function of delivering
`drugs via bolus inhalation dosing by 2003. (Relevant to Motivation to
`Combine in Grounds 1 and 2, and Secondary Considerations)
`In anticipated Exhibit 2108 at 33:24-35:9 and 44:18-45:5, Dr. Hill testified
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`that the Geller article (Ex. 1034) demonstrated the feasibility, tolerability, and
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`association with improvement in pulmonary function of delivering drugs via bolus
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`inhalation dosing by 2003.
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`IPR2021-00406
`Patent 10,716,793 B2
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`Dated: April 15, 2022
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`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
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`Petitioner’s Observations on the
`Cross-Examination of Dr. Hill
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`
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`By:
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`
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`/Erik B. Milch/
`Erik B. Milch
`Reg. No. 42,887
`Counsel for Petitioner
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`3
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`IPR2021-00406
`Patent 10,716,793 B2
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`Petitioner’s Identification of Improper
`Evidence and Arguments
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`CERTIFICATE OF SERVICE
`foregoing
`the
`The undersigned hereby certifies
`that a copy of
`PETITIONER’S OBSERVATIONS ON THE CROSS-EXAMINATION OF
`DR. HILL was served on counsel of record on April 15, 2022, by delivering a copy
`via email to the counsel of record for the Patent Owner at the following address:
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`UT-793@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`FOLEY & LARDNER
`UTCvLiquidia-IPR@mwe.com
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`
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`Dated: April 15, 2022
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`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
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`By:
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`
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`
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`/Erik B. Milch/
`Erik B. Milch
`Reg. No. 42,887
`Counsel for Petitioner
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