`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner.
`
`
`Case IPR2021-00406
`Patent 10,716,793
`
`
`PETITIONER’S OBSERVATIONS ON THE
`CROSS-EXAMINATION OF DR. HILL
`
`
`
`
`
`
`
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`Petitioner’s Observations on the
`Cross-Examination of Dr. Hill
`
`Petitioner files these observations on the 4/13/2022 deposition of Dr. Hill
`
`pursuant to the Board’s Order authorizing both parties to file observations “no later
`
`than two business days after the conclusion of the deposition.” (Paper 53, 4.)
`
`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,
`
`Dr. Hill testified that in his experience attending conferences like the European
`
`Society of Cardiology Congress and American Heart Association’s Scientific
`
`Sessions, at which Voswinckel JESC and JAHA were respectively presented, the
`
`conferences “compile . . . abstract issues that are generally disseminated as a
`
`supplement to the journal to the subscribers and also are available at the meeting
`
`site.” Id. He explains that his declaration statements and testimony about the public
`
`availability of Voswinckel JESC and JAHA “is consistent with [his] experience in
`
`attending these meetings. This is how these abstracts are handled.” Id.
`
`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
`
`experience, the average nebulization rate for continuous nebulizers in the 2006 time
`
`frame was 0.5 to 0.6 mL/min. In anticipated Exhibit 2108 at 29:17-31:10, Dr. Hill
`
`explains that even if the OptiNeb device used in Voswinckel has a “range that could
`
`1
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`be delivered” (i.e., if it could have delivered < 0.6mL/min), in “[his] experience
`
`Petitioner’s Observations on the
`Cross-Examination of Dr. Hill
`
`using continuous nebulizers, . . it would be extremely unusual to go to a dose less
`
`than around 0.3[mL/min] because there has to be a certain volume to generate a mist
`
`that the patient can then inhale[.]” In anticipated Exhibit 2108 at 45:17-46:8 and
`
`47:7-20, Dr. Hill further testified that though “there is a wide range . . . in terms of
`
`efficiency between nebulizers,” a POSA would have understood the Voswinckel
`
`JESC authors to have been “concerned about accurately dosing patients for the
`
`purposes of a study” and seen that the authors selected from a “line of nebulizers
`
`[that] are generally much more accurate in terms of the rate of delivery of aerosol
`
`to a patient, and accordingly, they would be at the higher range of efficiency[.]”
`
`Additionally, Dr. Hill testified that “as a POSA with experience using nebulizers, …
`
`[he] know[s] it would be important for authors of a study like this to select a device
`
`that they could rely on to deliver a reliable dose at a reliable delivery rate.” Id.
`
`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
`
`that the Geller article (Ex. 1034) demonstrated the feasibility, tolerability, and
`
`association with improvement in pulmonary function of delivering drugs via bolus
`
`inhalation dosing by 2003.
`
`
`
`2
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`Dated: April 15, 2022
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`Petitioner’s Observations on the
`Cross-Examination of Dr. Hill
`
`
`
`By:
`
`
`
`
`
`/Erik B. Milch/
`Erik B. Milch
`Reg. No. 42,887
`Counsel for Petitioner
`
`3
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`Petitioner’s Identification of Improper
`Evidence and Arguments
`
`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:
`
`UT-793@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`FOLEY & LARDNER
`UTCvLiquidia-IPR@mwe.com
`
`
`
`Dated: April 15, 2022
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`
`By:
`
`
`
`
`
`/Erik B. Milch/
`Erik B. Milch
`Reg. No. 42,887
`Counsel for Petitioner
`
`
`
`
`
`
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