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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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`
`_______________
`
`Case IPR2021-00406
`Patent 10,716,793
`_______________
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`PATENT OWNER’S MOTION TO EXCLUDE
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`4870-4914-3835
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`Case IPR2021-00406
`Patent 10,716,793
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`I.
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`INTRODUCTION
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`Patent Owner’s Motion to Exclude
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`
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`Under 37 CFR § 42.64(c), United Therapeutics Corporation (“UT”) moves
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`to exclude all or parts of the following exhibits:
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`Exhibit Description
`EX1037 English translation of
`OptiNeb® User Manual 2005
`EX1087 Butler Affidavit
`EX1112
`Reply Declaration of Sylvia
`(partial)
`Hall-Ellis, Ph.D.
`EX1114 American Heart Association
`2004 Online Archive
`EX1117 Voswinckel JAHA Supplement
`PubMed Search Results
`EX1120 Voswinckel JESC Web of
`Science Search Results
`EX1029 Ventavis® Label 2004
`EX1050 Pulmozyme® Label
`EX1066 AccuNeb® Label
`EX1074 Orenitram® Label
`EX1078 Azmacort® Label 2003
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`Reason to Exclude
`Hearsay; Lack of authentication; Lack of
`relevance; Lacks original writing
`Lack of personal knowledge & relevance
`Testimony not based on sufficient facts
`or analysis
`Hearsay
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`Hearsay
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`Hearsay
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`Lack of authentication
`Lack of authentication
`Lack of authentication
`Lack of authentication
`Lack of authentication
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`Petitioner relied on these exhibits in its Petition and/or Reply. The Petition
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`cites EX1037 (Paper 2 at 23) and the Reply cites EX1037 (Paper 44 at 12, 15) and
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`EX1087 (id., 14). EX1029 was cited throughout the Petition and Reply. E.g., Paper
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`2 at 17; Paper 44 at 22, 24. The Reply also cites EX1050 (Paper 44 at 12) and
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`heavily relies on EX1112, which in turn cites to EX1114, EX1117, and EX1120
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`(id. at 1-9, 8n.5, 14). UT moves to exclude these portions of the Petition and Reply.
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`Petitioner’s experts, Drs. Nicholas Hill and Igor Gonda, also rely on EX1037
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`(EX1002 at ¶¶34, 67, FN3, 161, 172), EX1029 (EX1002 at ¶¶36, 41, 42; EX1004
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`at ¶¶33, 56, 59, 51, 92, 104, 108, 131), EX1050 (EX1004 at ¶56), EX 1066
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`(EX1004 at ¶56), EX1074 (EX1004 at ¶136), and EX1078 (EX1002 at ¶119). UT
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`moves to exclude these portions of EX1002 and EX1004.
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`II.
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`PATENT OWNER TIMELY OBJECTED
`A. EX1037: English translation of OptiNeb® User Manual 2005
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`UT timely objected to EX1037 under Federal Rule of Evidence (“FRE”)
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`802, 402, 403, 901, and 902. Paper 20 at 6-7.
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`B.
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`EX1087: Butler Affidavit
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`EX1087 was served as supplemental evidence in an attempt to address UT’s
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`objections to EX1037, but it fails to remedy them. UT timely objected to EX1087
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`under FRE 602, 401, 402, and 403. Paper 46 at 2-3. Petitioner did not serve any
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`supplemental evidence in response.
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`C. EX1112: Reply Declaration of Sylvia Hall-Ellis, Ph.D. and
`Supporting Exhibits 1114, 1117, 1120
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`UT timely objected to EX1112 under FRE 702 and to supporting Exhibits
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`EX1114, EX1117, and EX1120 under FRE 802. Paper 46 at 6-11. Petitioner did
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`not serve any supplemental evidence in response.
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`D. EX1029: Ventavis® Label 2004
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`UT timely objected to EX1029 under FRE 901 and 902. Paper 20 at 8.
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`Petitioner served supplemental evidence in an attempt to address the objections,
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`but it fails to address the deficiencies.
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`E.
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`EX1050, 1066, 1074, 1078: Various Labels
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`UT timely objected to EX1050, EX1066, EX1074, and EX1078 under FRE
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`402, 403, 901 and 902. Paper 20 at 7-8. Petitioner did not serve any supplemental
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`evidence in response.
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`III. ARGUMENT
`A. EX1037 Should Be Excluded
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`EX1037, which purports to be an English translation of an undated1
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`German-language user manual for an OptiNeb® device, should be excluded as
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`falling woefully short of evidentiary standards. Petitioner has offered a translation
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`without the underlying German language document or competent testimony to
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`authenticate it. FRE 901-902. Even if Petitioner had properly authenticated
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`EX1037, it is being offered for the truth of the matter asserted—how specific
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`devices operated in a specific time period and what would have been known to a
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`1 Petitioner identifies it as a “2005” document in its exhibit list, but no such date is
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`present on the document, nor does the accompanying translator declaration indicate
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`any date or source for the document.
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`person of ordinary skill in the art—and Patent Owner has not proven that it falls
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`into any hearsay exception. FRE 802-807. Additionally, even if EX1037 was
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`authenticated and not hearsay (or excepted from the rule), EX1037 is irrelevant and
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`unfairly prejudicial because it is being used to show the state of the prior art while
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`lacking any verifiable publication date. FRE 402-403. Finally, EX1037 is not an
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`original writing and genuine questions regarding its authenticity and the
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`circumstances of its production make it unfair to admit. FRE 1001-1003.
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`In response to UT’s objection, Petitioner submitted EX1087 as supplemental
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`evidence, but as discussed below, EX1087 does not cure the deficiencies or
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`address the objections to EX1037.
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`1.
`EX1037 Constitutes Hearsay under FRE 802
`The Petition relies on EX1037 for the truth of the matter asserted directly
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`(Paper 2 at 23) and indirectly through the Hill declaration as alleged evidence that
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`a nebulizing rate of 0.6 mL/min and “pulsed ultrasonic nebulizer[s]” were known
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`in the prior art (Paper 2 at 23-24, 59). The Reply similarly relies on EX1037 (Paper
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`44 at 12, 14-15, n.10). Each of these assertions is hearsay.
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`Petitioner could have provided a translator declaration to identify which
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`German document was translated, but it failed to do so. Rather, the declaration
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`appended to EX1037 states it is a translation of “a user manual for OPTINEB®‐ir,”
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`and the Petition describes the Exhibit as allegedly from 2005 (Paper 2, vii).
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`EX1037, however, does not identify a publication date or include a copy of
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`the translated German document, and therefore the asserted publication date and
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`public availability of both are unknown. Petitioner asserts that EX1037 is from
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`2005 but offers no supporting evidence for that date or how a POSA could have
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`obtained the missing 2005 German original.
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`Petitioner attempted to use EX1087 (which is only present as supplemental
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`evidence in response to UT’s initial objection to EX1037) to address this
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`shortcoming, but EX1087 does not fix EX1037’s flaws. EX1087 includes, as
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`Exhibit E, a 2004 German-language OptiNeb® manual, but does not include an
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`English translation of that 2004 manual. Further, there are persistent
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`inconsistencies throughout EX1087 that undermine its credibility. The declarant—
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`Mr. Butler—asserts that “Exhibit E” dates back to 2004 (EX1087 at ¶7), but
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`“Exhibit D” of his declaration shows screen captures from 2005 (see id. at 4, 6, 8,
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`10; EX2095, 28:3-14). Petitioner has not reconciled these inconsistencies, and
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`there is no assertion or evidence that the German translator of EX1037 relied on
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`the 2004 document found in EX1087.
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`Thus, any use of EX1037 as evidence of alleged knowledge of a POSA at a
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`particular time is hearsay. Chambers v. Mississippi, 410 U.S. 284, 298 (1973)
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`(“The hearsay rule … is based on experience and grounded in the notion that
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`untrustworthy evidence should not be presented to the triers of fact.”); ServiceNow,
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`Inc. v. Hewlett-Packard Co., IPR2015-00716, Paper No. 13 at 8, 15-17 (PTAB
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`Aug. 26, 2015).
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`2.
`Petitioner Has Not Authenticated EX1037
`Petitioner should not be allowed to use EX1037 for any purpose (whether
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`EX1087 is entered) because Petitioner failed to authenticate it. EX1037 is not self-
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`authenticating (FRE 902), and Petitioner has not provided a German-language
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`manual for the alleged OptiNeb® device dated 2005 or a declaration authenticating
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`EX1037. Thus, EX1037 should be excluded. FRE 901 and 902.
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`The generic declaration appended to EX1037 does not state, let alone prove,
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`that EX1037 is a true and accurate translation of any specific document. It is not
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`sufficient for the translator to attest that he translated an unidentified foreign
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`language document that is not of record. EX1037 at 33. Petitioner failed to cure
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`these defects. United States v. Perlmuter, 693 F.2d 1290, 1293 (9th Cir. 1982)
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`(“[C]ertainly it is not enough that the documents present an ‘aura of
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`authenticity’… . [T]he trial court abused its discretion by admitting the
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`unauthenticated documents into evidence.”).
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`Further, Petitioner’s failure to provide either an original of the German-
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`language manual or a duplicate contravenes FRE 1001-1003. There is a genuine
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`question as to the authenticity, accessibility, and existence of a 2005 German-
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`language OptiNeb® manual. FRE 1003.
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`3.
`EX1037 Is Not Relevant and May Cause Confusion
`EX1037 is not relevant to the device used in Voswinckel JESC or
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`Voswinckel JAHA (EX1007-EX1008). Petitioner states that EX1037 relates to a
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`“2005” nebulizer, while JESC/JAHA state they are from 2004. EX1007 at 1,
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`EX1008, at 1.
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`4.
`EX1037 Does Not Comply with PTAB Trial Practice
`EX1037 does not include a copy of the purported German-language
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`document for which it is allegedly a translation. This contravenes 37 C.F.R.
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`§ 42.63(b) (“When a party relies on a document or is required to produce a
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`document in a language other than English, a translation of the document into
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`English and an affidavit attesting to the accuracy of the translation must be filed
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`with the document.”) (emphasis added), which is a procedural requirement for any
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`party choosing to rely on a foreign language document. Despite UT’s objections,
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`Petitioner has not provided a document that clearly corresponds to the allegedly
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`translated German-language manual from 2005, or a supplemental exhibit
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`including the original document, an English-language translation, and an affidavit
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`attesting to the accuracy of the translation, as required by § 42.63(b).
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`For all of the foregoing reasons, EX1037 cannot and should not be relied on
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`as evidence, and UT respectfully requests that it be excluded from the record.
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`B.
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`EX1087 Should Be Excluded
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`EX1087 purports to be an affidavit by Christopher Butler, the Office
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`Manager of the Internet Archive. EX1087 at 1. However, this exhibit—and the
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`record, generally—does not show that Mr. Butler possessed any personal
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`knowledge regarding what German-language document was allegedly translated as
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`EX1037. Thus, Mr. Butler’s testimony is both irrelevant and confusing.
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`Petitioner submitted EX1087 in an attempt to cure the deficiencies of
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`EX1037. The Butler declaration from 2021, however, fails to prove that he has
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`personal knowledge regarding whether the purported OptiNeb® user manual from
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`2004 that he provides as “Exhibit E” of EX1087 is the German-language document
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`that was translated as EX1037 in 2017, several years earlier, or relates to any other
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`exhibit. Accordingly, EX1087 does not comply with FRE 602 and cannot fix the
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`flaws in EX1037.
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`Petitioner should have provided a further declaration of William L.
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`Chisholm, the translator of EX1037 (see EX1037 at 33), stating that the German-
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`language document unearthed by Mr. Butler was the document that was translated.
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`Petitioner provided no such declaration to bridge this gap.
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`It does not matter that Mr. Butler was able to locate a user manual—one
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`with a different apparent publication date from the one translated as EX1037.
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`Petitioner’s evidentiary burden is not met by showing that some OptiNeb® user
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`manual was online at some time. It must provide the specific OptiNeb® manual on
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`which it relies. Anything else is irrelevant.
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`Lastly, EX1087 fails the test for relevance under FRE 401. Although
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`EX1087 purports to provide a manual from 2004, EX1037 purports to provide a
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`manual from 2005. And there are inconsistencies within EX1087 itself, as
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`described above. Thus, EX1087 does not make the authenticity or identity of
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`EX1037 any more clear or probable than it would be in the absence of EX1087,
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`and it is more likely to cause confusion than provide clarity. FRE 403.
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`For all of the foregoing reasons, EX1087 cannot and should not be relied on
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`as evidence, and UT respectfully requests that it be excluded from the record.
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`C. EX1114, EX1117, EX1120, and the Portions of EX1112 Relying on
`these Exhibits Should Be Excluded
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`EX1112 is the reply declaration of Sylvia Hall-Ellis, Ph.D., which opines,
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`inter alia, about the alleged public accessibility of Voswinckel JAHA (EX1008)
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`and Voswinckel JESC (EX1007) and the Supplements containing them. EX1112
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`cites to EX1114, EX1117, and EX1120, which purport to be an American Heart
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`Association Online Archive, PubMed Search Results showing EX1008, and Web
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`of Science Search Results showing EX1007, respectively. UT objected to each of
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`EX1114, EX1117, and EX1120 on hearsay grounds (Paper 46 at 7-11) to the extent
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`Petitioner or Dr. Hall-Ellies relied one them to prove that EX1007 or EX1008 (or
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`the Supplements containing them) were publicly accessible before the priority date.
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`Apple Inc. v. DSS Tech. Management, Inc., IPR2015-00373, Paper No. 8 at 10-11
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`(PTAB June 25, 2015) (denying institution because a “stamped date…appears to
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`be a hearsay statement to the extent that it would be offered for its truth”);
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`ServiceNow, Inc. v. Hewlett-Packard Co., IPR2015-00716, Paper No. 13 at 8, 15-
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`17 (PTAB Aug. 26, 2015) (finding that the date on the face of an exhibit, the
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`copyright date, and other indications of availability online to prove public
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`availability as of a specific date are hearsay).
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`The Hall-Ellis testimony that relies on these exhibits (EX1112, ¶¶39, 60, 87)
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`should also be excluded. Although experts can rely on hearsay in some
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`circumstances (FRE 703), the testimony must be “based on sufficient facts or data”
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`and “the product of reliable principles and methods” (FRE 702(b), (c)). As
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`discussed below, the Hall-Ellis testimony meets none of these requirements.
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`First, EX1114 does not address or prove that the JAHA Supplement—as
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`distinct from standard journal volumes—was available in 2004. Petitioner asserts
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`that EX1114 shows that Circulation journal Volume 110, Issue 17 (October 26,
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`2004) was available online by the date of capture by the Wayback machine
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`(purported to be Nov. 2004 (EX1112, ¶39)). However, EX1008 was not published
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`in Volume 110, Issue 17. It was included only in the Supplement that is not listed
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`in EX1114. Compare EX1093 at 1 (showing the cover page for Vol. 110, Issue 17)
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`with EX1094 at 1-2 (showing the Supplement to Vol. 110, Issue 17); see also
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`EX1114 at 5 (showing Volume 110, Issue 17 as spanning 220 pages) and EX1112,
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`¶36 (noting that the Supplement containing EX1008 is 1,102 pages). Moreover,
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`pages 6-11 of EX1114 purport to show the contents of Circulation Volume 110,
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`Issue 17 from October 26, 2004, but it does not list the Supplement or its contents.
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`Indeed, Dr. Hall-Ellis admitted that the link to the October 26, Volume 110, Issue
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`17 in EX1114 cannot be referring to the 1,102 page Supplement, and that she never
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`showed that EX1008 could be reached from the website(s) shown in EX1114. See
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`EX2094, 50:11-56:22. Thus, EX1114 does not show (let alone reliably show) that
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`the JAHA Supplement was publicly accessible as of the Wayback machine’s
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`capture date, and it should be excluded to the extent that Petitioner relies on
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`EX1114 to show a public accessibility date of EX1008 or the Supplement.
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`Because EX1114 does not show anything about the availability of the
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`Supplement or EX1008, the Hall-Ellis testimony (EX1112, ¶39) suggesting that
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`EX1008 or the JAHA Supplement were available before the priority date should
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`also be excluded under FRE 702(b)-(c) and 703, since such testimony is not based
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`on sufficient facts or the product of reliable principles. Likewise, Petitioner should
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`not be able to rely on this testimony in its Reply either. See Reply at 8 n.5.
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`Second, EX1117 is likewise deficient. Buried down on page 17, these
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`purported PubMed search results include entry 152—titled “Abstracts from the
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`2004 Scientific Sessions of the American Heart Association,”—but that entry also
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`states “[n]o authors listed” and “[n]o abstract available.” EX1117 at 17. Dr. Hall-
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`Ellis admitted that she provided no evidence that the link provided in search result
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`152 would lead to the actual abstracts provided in EX1007-EX1008. EX2094 at
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`27:11–28:9. Moreover, the search results of EX1117 were not conducted via the
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`Wayback machine to reflect what a POSA could have seen in 2006; rather this was
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`a search Dr. Hall-Ellis conducted in 2022. Id. at 24:10–26:6. Thus, EX1117 is not a
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`reliable indication that the JAHA Supplement could be “found … on well known
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`databases” in 2006 such that it “qualifies as a publicly accessible printed
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`publication,” as Dr. Hall-Ellis alleges (EX1112, ¶60). EX1117 should be excluded
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`as hearsay since Petitioner seeks to rely on it as evidence of public availability of
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`EX1008 before the priority date. The Hall-Ellis testimony based on this evidence
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`(EX1112, ¶60) should likewise be excluded under FRE 702(b)-(c) and 703.
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`Third, EX1120 and Dr. Hall-Ellis’ reliance thereon (EX1112, ¶87) is also
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`deficient. EX1120 purports to show a citation to EX1007 but lacks the actual text
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`of the abstract. Dr. Hall-Ellis admitted that (i) she did not search for or show the
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`actual abstract, (ii) her search was conducted in 2022, and (iii) she did not use the
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`Wayback machine to show what might have been available in 2004-2005. EX2094
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`at 41:18-42:20. Thus, EX1120 should be excluded as hearsay since Petitioner seeks
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`to rely on it as evidence of public availability of EX1007 before the priority date.
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`The Hall-Ellis testimony based on it (EX1112, ¶87) should likewise be excluded
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`under FRE 702(b)-(c) and 703.
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`In sum, none of Exhibits 1114, 1117, or 1120 show that Dr. Hall-Ellis was
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`able to access EX1007 or EX1008 in 2022, much less that they were accessible to
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`a POSA in 2004-2005. As such, Exhibits 1114, 1117, and 1120 are not “sufficient
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`facts or data” for Dr. Hall-Ellis’s opinions, nor are they “the product of reliable
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`principles and methods” for showing accessibility in 2004-2005 (or 2006). The
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`Hall-Ellis testimony stemming from these exhibits fails to meet the requirements of
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`FRE 702(b) and (c) (as well as FRE 703) and should therefore be excluded.
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`D. EX1029 Should Be Excluded
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`EX1029 purports to be the Ventavis® Label from 2004. EX1029 is not self-
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`authenticating under FRE 902 and no authenticating evidence was provided with
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`EX1029. The exhibit does not identify a date, where it was kept, or how it was
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`obtained. For at least these reasons, EX1029 lacks sufficient indicia to support a
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`finding that it is what it purports to be, and it should be excluded from the record,
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`along with the sections of the Petition (Paper 2 at 17), the Reply (Paper 44 at 22),
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`and EX1002 (¶¶36, 41, 42) that rely on EX1029. Celltrion, Inc. v. Biogen, Inc.,
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`IPR2016-01614, Paper No. 65 at 17-20 (PTAB Feb. 21, 2018).
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`E.
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`EX1050, EX1066, EX1074, and EX1078 Should Be Excluded
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`EX1050, EX1066, EX1074, and EX1078 purport to be a Pulmozyme®
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`Label, an AccuNeb® Label, an Orenitram® Label, and an Azmacort® Label,
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`respectively. None of these exhibits are self-authenticating under FRE 902, and
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`Petitioner failed to provide authenticating evidence with its Petition or Reply, or in
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`response to UT’s timely objections for lack of authentication (Paper 20 at 7-8). The
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`exhibits do not identify a date, where they were kept, or how they were obtained.
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`Thus, they lack sufficient indicia to support a finding that they are what they
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`purport to be, so these exhibits should be excluded. Celltrion, IPR2016-01614,
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`Paper No. 65 at 17-20.
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`Date: April 20, 2022
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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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 to Exclude was served on counsel of record on April 20, 2022, by
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`filing this document through the PTAB E2E System as well as delivering a copy
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`via email to the counsel of record for the Petitioner at the following address:
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`zLiquidiaIPR@cooley.com
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`ielrifi@cooley.com
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`emilch@cooley.com
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`dkannappan@cooley.com
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`ssukduang@cooley.com
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`Date: April 20, 2022
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
`
`4870-4914-3835
`
`
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