Case No. IPR2021-00406
`Patent Owner’s Motion for Observations
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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.,
`Petitioner,
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`v.
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`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
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`IPR2021-00406
`U.S. Patent No. 10,716,793
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`PATENT OWNER’S MOTION FOR OBSERVATIONS ON
`APRIL 13, 2022 DEPOSITION OF DR. HILL
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`Patent Owner’s Motion for Observations
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, Inc.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS ON
`APRIL 13, 2022 DEPOSITION OF DR. HILL
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`Case No. IPR2021-00406
`Patent Owner’s Motion for Observations
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`Patent Owner hereby submits the following observations pursuant to the
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`March 15, 2022 teleconference and the Board’s Order (Paper No. 53).
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`1.
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`In EX2108 at 14:20-15:18, Dr. Hill testified that he did not attend two
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`conferences. This is relevant to his opinions that a POSA would have attended
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`them and alleged public availability of EX1007-1008. EX1106, ¶¶22, 28; cf.
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`EX1002 (“I qualify as a POSA.”). It is also relevant to Patent Owner’s argument
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`that Petitioner cannot show availability by claiming the POSA would have
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`attended. Sur-reply at 2-5.
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`2.
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`In EX2108 at 18:7-16, 20:25-21:4, Dr. Hill testified that his
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`understanding of date stamps came from counsel, which is relevant to his opinions
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`on public availability of the abstracts. E.g., EX1107, ¶¶24, 31-32.
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`3.
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`In EX2108 at 17:13-17, Dr. Hill testified that a lack of supporting
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`evidence undermines an opinion. This is relevant to his opinions that lack
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`supporting evidence by diminishing any weight they could carry. E.g., EX1106,
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`¶44 (“standard” temperatures and humidity levels); ¶57 (“sheep model is well-
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`accepted for study of the pulmonary circulation); ¶60 (“this dose calculation
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`method was standard in the art in May 2006”) (citing EX1001, 9:5-23), but cf.
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`EX1001 9:5-23 (regarding Respimat® soft mist inhaler and “time following TRE
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`application,” not nebulization time); ¶60 (“POSAs in 2006 would not have
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`accounted for these variables” and POSAs “would have understood that the prior
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`art … already accounted for such variables”); ¶61 (“average” rate of 0.5 mL/min)
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`(see also EX2108, 23:8-11); ¶73 (calculating doses using concentration, time, and
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`Case No. IPR2021-00406
`Patent Owner’s Motion for Observations
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`“known volumes delivered” is “standard”) (emphasis added).
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`4.
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`In EX2108 at 22:3-24:5, 24:22-29:21, Dr. Hill testified that: he
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`“believe[s]” he reviewed EX1087, but not the German language manual therein
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`(see EX1087 at 27 (“Verneblerleistung … < 0.6 ml/min”), EX1107 at 6 (not listing
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`EX1086)); EX1086 identifies a rate of “less than 0.6 mL/min,” that 0.5, 0.3, and
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`0.1 are all less than 0.6, and that the manual does not identify rates the nebulizer
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`actually provides in operation. This is relevant to Dr. Hill’s calculations relying on
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`a 0.6 mL/min rate and claims it “accounts for” all variables because it shows the
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`calculations were based on an incorrect assumption. E.g., EX1107, ¶¶63, 92.
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`5.
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`In EX2108 at 36:2-37:1, 47:7-17, Dr. Hill testified that: EX1034
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`describes conventional nebulizers as having delivery efficiency of only 10-20%; he
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`did not review the Cipolla article cited in EX1034; nebulizers have “variable
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`efficiency” and “a wide range … in terms of efficiency.” This testimony is relevant
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`to Dr. Hill’s calculations that used either no efficiency or an assumed 50%
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`efficiency because they were based on incorrect assumptions.
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`6.
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`In EX2108 at 38:13-39:10, 41:6-23, Dr. Hill testified that: Tyvaso®
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`does not satisfy claim 1 of EX1001 because it is administered in “four single event
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`doses” per day and EX1008’s compassionate use patients also received four doses
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`per day. This testimony is relevant to claim 1’s “therapeutically effective single
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`event dose” and, under Dr. Hill’s interpretation of “single event dose,” is relevant
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`to any Liquidia position that the compassionate use patients in EX1008 disclose
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`therapeutic efficacy within claim 1. Cf. EX1106, ¶88; Sur-reply at 22-23.
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`Case No. IPR2021-00406
`Patent Owner’s Motion for Observations
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`Date: April 15, 2022
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`FOLEY & LARDNER LLP
`Washington Harbour
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`3000 K St., NW
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`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile: (202) 672-5399
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`Respectfully submitted,
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`By / Stephen B. Maebius /
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`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`Case No. IPR2021-00406
`Patent Owner’s Motion for Observations
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Motion for Observations was served on counsel of record for Petitioner
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`on April 15, 2022 by delivering a copy via email to the counsel of record for the
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`Petitioner at the following addresses:
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`zLiquidiaIPR@cooley.com
`ielrifi@cooley.com
`emilch@cooley.com
`dkannappan@cooley.com
`ssukduang@cooley.com
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`Date: April 15, 2022
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`FOLEY & LARDNER LLP
`Washington Harbour
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`3000 K St., NW
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`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile: (202) 672-5399
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`By / Stephen B. Maebius /
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`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`4
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