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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.
`
`
`_______________
`
`Case IPR2021-00406
`Patent 10,716,793
`_______________
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION
`TO EXCLUDE
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`
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`4894-6420-3806
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`Case IPR2021-00406
`Patent 10,716,793
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`
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`I.
`
`INTRODUCTION
`
`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
`
`United Therapeutics Corporation (“Patent Owner” or “UTC) opposes
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`Petitioner’s Motion to Exclude (Paper No. 65) (“Pet. MTE”) Exhibits 2100, 2101,
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`2102, 2103, and deposition exhibit 2092 of Exhibit 2094. Petitioner moved to
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`exclude the Exhibits for the following alleged grounds:
`
`Exhibit
`
`Description
`
`Deposition Exhibit
`2092 (attached to
`EX2094 at 63-65)
`EX2100
`
`EX2101
`
`EX2102
`
`EX2103
`
`British Library Communication
`from Rupert Lee
`
`Schill: Multisonic, Inhaling
`with ultrasonic infraControl,
`Instructions for Use (2004)
`(Exhibit from March 14, 2022
`Deposition of Dr. Gonda,
`referenced as “Tab 6”)
`Schill: Multisonic, Inhaling with
`ultrasonic infraControl,
`Instructions for Use (Exhibit
`from March 14, 2022
`Deposition of Dr. Gonda,
`referenced as “Tab 5”)
`DeVilbiss, UltraNeb, Ultrasonic
`Nebulizer User Manual (Exhibit
`from March 14, 2022
`Deposition of Dr. Gonda,
`referenced as “Tab 9”)
`Lieberman, et al., In Vitro
`Performance of the MyNeb™
`Nebulizer: A New Portable
`Aerosol Delivery System
`(Exhibit from March 14, 2022
`
`Alleged Reason to
`Exclude
`Allegedly incomplete
`document; not
`authenticated
`Allegedly not
`authenticated (no date
`or origin information)
`
`Allegedly not
`authenticated (no date
`or origin information)
`
`Allegedly not
`authenticated (no date
`or origin information)
`
`Allegedly not
`authenticated (no date
`or origin information)
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`4894-6420-3806
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`1
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`Case IPR2021-00406
`Patent 10,716,793
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`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
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`Deposition of Dr. Gonda,
`referenced as “Tab 4”)
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`II. ARGUMENT
`A. Deposition Exhibit 2092 of EX2094: British Library
`Communication
`
`There is no basis to exclude deposition exhibit 2092, which is authentic and
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`not incomplete. In fact, it is an exact copy of EX2092 from IPR2017-01261
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`showing an email communication from the British Library, and was used at the
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`deposition of Dr. Hall-Ellis to impeach the basis for her opinions. See, e.g.,
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`EX2094 at 20:22-4 (introducing Exhibit 2092). Unable to identify a legitimate
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`reason to exclude this exhibit, it appears that Petitioner challenges this exhibit as a
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`way to further argue on the merits.1
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`First, Petitioner’s half-hearted attempt to exclude deposition exhibit 2092 on
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`
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`1 Petitioner’s attempts to argue the merits of the underlying issues in its MTE brief
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`(e.g. Pet. MTE, 3) is improper. P.T.A.B. Consol. Trial Practice Guide (Nov. 2019)
`
`at 79 (“A motion to exclude must explain why the evidence is not admissible (e.g.,
`
`relevance or hearsay) but may not be used to challenge the sufficiency of the
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`evidence to prove a particular fact.”). Thus, while Patent Owner disagrees on the
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`merits, it does not address the merits in this Opposition.
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`Patent Owner’s Opposition To
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`authenticity grounds under FRE 901 (Pet. MTE, 4) fails as a matter of law and fact.
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`Under FRE 901, an email may be authenticated by reference to its “appearance,
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`contents, substance, internal patterns, or other distinctive characteristics of the
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`item, take together with all the circumstances.” See United States v. Siddiqui, 235
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`F.3d 1318, 1322 (11th Cir. 2000), cert. denied, 533 U.S. 940 (2001). On its face,
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`deposition exhibit 2092 of EX2094 shows that the document is indeed an April
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`2018 email from Mr. DiNatale to Mr. Maebius, forwarding an email from Mr.
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`Rupert Lee of the British Library.
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`Further, testimony from a witness with knowledge of an email exchange is
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`prima facie evidence of authenticity. United States v. Gagliardi, 506 F.3d 140, 151
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`(2d Cir. 2007) (“[T]he standard for authentication is one of ‘reasonable
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`likelihood’...and is ‘minimal’...both the informant and Agent Berglas testified that
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`the exhibits were in fact accurate records of [defendant’s] conversations with Lorie
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`and Julie. Based on their testimony, a reasonable juror could have found that the
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`exhibits did represent those conversations, notwithstanding that the e-mails and
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`online chats were editable.”). As explained by the email’s author, Mr. Jim
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`DiNatale, the document in this exhibit is a true and correct copy of an email he
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`forwarded to attorney Steve Maebius at Foley & Lardner LLP, sharing the
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`response Mr. DiNatale had received from Mr. Rupert Lee of the BIPC Research
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`Patent Owner’s Opposition To
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`Services team at the British Library after a series of telephone calls and email
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`exchanges. See EX2105, ¶¶2-3.
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`Accordingly, deposition exhibit 2092 has been properly authenticated, and
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`Liquidia’s objection under FRE 901 should be denied.
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`Second, Petitioner contends that deposition exhibit 2092 should be excluded
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`under FRE 106 because it is allegedly an incomplete document, based upon
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`Petitioner’s pure speculation that there was an original list of questions or other
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`correspondence that were intentionally deleted from this document. Pet. MTE, 3-4.
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`This argument likewise fails.
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`First and foremost, FRE 106 is not even a rule by which evidence is
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`excluded. See FED. R. EVID. 106; see also U.S. v. Jamar, C.A.4 (Va.) 1977, 561
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`F.2d 1103 (noting that the purpose of this rule is “to permit the contemporaneous
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`introduction of recorded statements that place in context other writings admitted
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`into evidence which, viewed alone, may be misleading.”); U.S. v. Branch, C.A.5
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`(Tex.) 1996, 91 F.3d 699 (noting that FRE 106 codifies the common-law “rule of
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`completeness,” and its purpose is to permit contemporaneous introduction of
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`recorded statements that place in context other writings admitted into evidence
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`which, viewed alone, may be misleading). Petitioner’s motion under FRE 106 fails
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`for this reason alone.
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`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
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`Moreover, as is clear from the face of the document, deposition exhibit 2092
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`is an exact copy of EX2092 from another proceeding, IPR2017-01621, which
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`involved the same JAHA Abstract at issue in this proceeding, and in which Dr.
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`Hall-Ellis likewise participated (see, e.g., EX2043, 149:21-23). EX2092 from that
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`other IPR is publicly available, and a simple comparison confirms deposition
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`exhibit 2092 is identical to EX2092 from IPR2017-01621. Having testified that
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`she participated in IPR2017-01621, Dr. Hall-Ellis was cross-examined using
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`EX2092 in this proceeding because she failed to acknowledge this exhibit in
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`rendering contradictory opinions in this case directly involving the availability of
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`the JAHA Abstract. See EX1112, ¶85; EX2094, 20:22–24:7.2 In short, deposition
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`
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`2 The fact that Dr. Hall-Ellis participated in IPR2017-01621 and cited other
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`exhibits from that proceeding in her declarations here (see, e.g., EX1036, 31 n.21
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`& 37 n.22; EX1112, ¶37, 81), belies Petitioner’s argument that “Dr. Hall-Ellis had
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`no reason to have seen the exhibit before or have knowledge of its origins or
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`contents” (Pet. MTE, 3). Indeed, given Dr. Hall-Ellis’ reliance on other statements
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`from the British Library to try to show public availability of the JAHA Abstract in
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`this case (see EX1112, ¶85)), EX2092 from IPR2017-01621 should have been
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`Patent Owner’s Opposition To
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`exhibit 2092 as filed in this case is a complete copy properly used to cross-examine
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`Dr. Hall-Ellis.
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`Moreover, Petitioner’s claims that parts of the communications between Mr.
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`DiNatale and the British Library “appear to be deleted” (Pet. MTE, 4) are pure
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`speculation. Speculation regarding some unproven alteration or deletion to a
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`document is not a basis for exclusion under FRE 106. To the extent Liquidia
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`genuinely believed there was anything missing from this document, it could have
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`sought to introduce additional evidence to correct any allegedly misleading
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`impression. See United States v. Adams, 722 F.3d 788, 826, 2013 U.S. App.
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`LEXIS 14418, *83-84, 2013 FED App. 0179P (6th Cir.), 45-46, 2013 WL
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`3717429 (6th Cir. Ky. 2013) (“The ‘rule of completeness’ allows a party to correct
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`a misleading impression created by the introduction of part of a writing or
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`conversation by introducing additional parts of it necessary to put the admitted
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`
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`served on Patent Owner in this proceeding pursuant to 37 C.F.R. § 42.51(b)(1)(iii).
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`At a minimum, it was not unreasonable for Patent Owner to have impeached Dr.
`
`Hall-Ellis during her deposition regarding her testimony in paragraph 85 using this
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`pre-existing document from a proceeding that involved both Dr. Hall-Ellis and the
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`same public-availability question regarding the JAHA Abstract.
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`Patent Owner’s Opposition To
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`portions in proper context.”). Petitioner did not do so.
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`Petitioner also complains that Mr. DiNatale’s declaration “provides no
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`details as to exactly what questions led to the response in [deposition exhibit
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`2092]” (id. at 3) and that it is allegedly unclear “in what context this email
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`originated” or “in what capacity the British Library contact” was responding (id. at
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`4), but these are substantive arguments, not proper evidentiary objections under
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`FRE106. P.T.A.B. Consol. Trial Practice Guide (Nov. 2019) at 79 (“A motion to
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`exclude must explain why the evidence is not admissible (e.g., relevance or
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`hearsay) but may not be used to challenge the sufficiency of the evidence to prove
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`a particular fact.”). Petitioner could have put this document into the proceeding
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`earlier and sought discovery related to it, had Petitioner so desired. Petitioner’s
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`failure to timely seek discovery related to deposition exhibit 2092 does not justify
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`exclusion under FRE 106.
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`Rather, the Board has established that FRE 106 requires that the context of a
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`witness’s testimony (i.e., Dr. Hall-Ellis’s cross-examination) should be considered
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`contemporaneously when the Board evaluates such witness’s testimony. See
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`Zhongshan Broad Ocean Motor Co. et al. v. NIDEC Motor Corp., IPR2014-
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`01121,-01122 (Sept. 10, 2015) (Paper 34) (allowing a Patent Owner to file a chart
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`identifying portions of deposition transcript as an exhibit); see also Ascend
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`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
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`Performance Materials Operations LLC v. Samsung SDI Co., Ltd., IPR2020-
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`00349, Paper 53, at 12 (July 15, 2021).
`
`In Ascend, the Board held that “if exhibits are introduced during a
`
`deposition for the purposes of testing witness’ testimony, a party should be able
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`to submit those exhibits with the transcript, so the board has full context
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`available in order to evaluate the testimony.” Id. In Ascend, three exhibits
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`submitted for the first time in a sur-reply along with deposition transcript were
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`proper evidence to submit for the purpose of evaluating the testimony of the
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`deponent. Id. at 12-13. Importantly, each of the exhibits were introduced during
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`the deposition and were objected at the time of the deposition. Id.
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`In Patent Owner’s Sur-Reply, deposition exhibit 2092 was submitted in
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`order to impeach the testimony of Dr. Hall-Ellis in relying on an unsworn,
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`conclusory statement from a librarian at the British Library that the JAHA
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`Supplement was “available for public use.” (Paper 44, at 7-9). More
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`specifically, it was submitted to dispute Dr. Hall-Ellis’ testimony that the JAHA
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`Supplement was “available for public use” at the British Library (see EX1112,
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`¶85). Failing to admit the document would result in an omission of evidence
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`necessary to provide the Board with the full context of the deposition testimony.
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`In particular, deposition exhibit 2092 is relevant to the context and veracity of Dr.
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`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
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`Hall-Ellis’ testimony that the JAHA Supplement was “available for public use”
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`because the exhibit contradicts the testimony of Dr. Hall-Ellis.
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`Accordingly, deposition exhibit 2092 should not be excluded under FRE 106
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`and/or 901.
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`B.
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`EX2100 and EX2101: Schill Instructions for Use
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`Petitioner’s motion to exclude EX2100 and EX2101 under FRE 901 should
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`be denied. As an initial matter, Petitioner’s motion is conditional—Petitioner only
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`moves for exclusion “to the extent the Board finds that the proffered Internet
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`Archive declarations by Petitioner (EX1087 and EX1115) is insufficient evidence
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`of the origins and/or dates of public availability of the documents[.]” Patent Owner
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`notes that (1) this condition is unclear at least as to “the documents,” which are not
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`identified, and (2) there are issues with EX1037 beyond dates and availability. See
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`Paper No. 66 at 5-10 (citing reasons to exclude). Further, the Board stated with
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`respect to EX1037 that Petitioner’s expert Dr. Hill relied on it “not as prior art but
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`merely as evidence of the general knowledge in the art at around the time of the
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`invention.” Inst. Dec. (Paper No. 18) at 24. If EX1037 is not excluded, EX2100-
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`2101 should likewise not be excluded for similar reasons.
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`Regardless, there is no basis to exclude either EX2100 or EX2101 (even if
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`EX1037 is excluded). Petitioner contends that EX2100-2101 are undated and lack
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`Patent Owner’s Opposition To
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`information about origin or dates of public availability. But unlike EX1037,
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`EX2100-2101 are not translations with missing information required for
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`authentication or compliance with PTAB rules. They are product manuals, in
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`English, readily available online. Petitioner contends that “Mr. Frank-White’s
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`declaration allegedly provides no pathway as to how a POSA would be able to find
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`EX2100 or EX2101 as of 2006.” Pet. MTE at 5. Public availability is a separate
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`issue from authenticity under FRE 901, however, and Liquidia has not cited
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`anything about the exhibits’ appearance, contents, substance, or archived location
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`at www.schillmedical.co.uk that allegedly shows inauthenticity. EX2106 at ¶5,
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`pp.4, 34. Moreover, “[s]tatus as a prior art printed publication is a substantive
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`issue, not an evidentiary issue.” Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-
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`02187, Paper 42 at 17. Regardless, Patent Owner submitted a signed declaration by
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`Mr. Frank-White showing that the URLs associated with the contents provided in
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`EX2100 and 2101 were recorded on January 26, 1997, prior to the 2006 effective
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`date.3
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`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
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`Petitioner’s motion should also be denied because EX2100-2101 were used
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`during Dr. Gonda’s deposition to cross-examine him on the alleged bases for his
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`opinions regarding device output rates and efficiency. See, e.g., EX2099 at 164:5-
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`14 et seq. EX2101 and EX2100 provide context to the deposition of Dr. Gonda,
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`and illustrate that Petitioner’s reliance on “typical” nebulization rates “misapplies
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`and misrepresents the evidence.” Patent Owner’s Sur-Reply, at 13-14, 16. The
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`requested exclusion of EX1037 does not change the fact that EX2100-2101 were
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`used to test and undermine Dr. Gonda’s opinions. Ascend Performance, IPR2020-
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`00349, Paper 53, at 12 (“[I]f exhibits are introduced during a deposition for the
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`purposes of testing witness’ testimony, a party should be able to submit those
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`exhibits with the transcript, so the board has full context available in order to
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`evaluate the testimony.”); see also Patent Owner’s Sur-Reply, at 13-14.
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`Excluding EX2092 would result in an incomplete record that omitted evidence
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`
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`3 Petitioner complains that Mr. Frank-White did not state whether EX2100-2101
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`are the same documents as he attached to his declaration. Petitioner has both
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`documents, which can easily be compared, and failed to identify any differences
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`between them.
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`Patent Owner’s Opposition To
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`necessary to provide the Board with the full context of the deposition testimony.
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`For all of the foregoing reasons, the board should deny Petitioner’s motion
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`to exclude EX2100 and EX2101.
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`C. EX2102: DeVilbiss UltraNeb Ultrasonic Nebulizer User Manual
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`Liquidia’s motion to exclude EX2102 under FRE 901 should also be denied.
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`Petitioner contends that EX2102 lacks information on origin or date of public
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`availability, but conspicuously fails to assert that EX2102 is not authentic. In fact,
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`Petitioner’s expert testified that he had no reason to believe the information in
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`EX2102 was inaccurate. EX2099, 184:11-17. There is no basis to contend, and
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`Petitioner has not contended, that EX2102 is not what it purports to be. Cf. FRE
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`901(a). The motion should fail for that reason alone.
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`Petitioner’s point that “[l]arge chunks” of the document are in languages
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`other than English is inapposite. The portions used at Dr. Gonda’s deposition and
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`cited in Patent Owner’s sur-reply are in English. E.g., Sur-reply (Paper No. 55) at
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`14 (citing EX2102 at 27).4
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`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
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`Petitioner’s second point, that the document was introduced at Dr. Gonda’s
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`deposition “without establishing that [he] had ever seen the document before”
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`actually proves why EX2102 is relevant and admissible. Dr. Gonda’s Reply
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`Declaration asserts various “average” and “conventional” values (e.g., EX1107,
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`¶¶17-25, 45, 48) and relies on Gessler (EX1062), which is why Patent Owner
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`tested the basis for his assumptions about average values by inquiring whether he
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`had ever reviewed EX2102. See, e.g., EX2099, 180:22-183:25.
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`In addition, like EX2100-2101 above, EX2101 should not be excluded
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`(1) if EX1037 is allowed, “as evidence of the general knowledge in the art at
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`around the time of the invention” (Inst. Dec. (Paper No. 18) at 24), and (2) as
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`context for the cross-examination of Dr. Gonda on the basis for his reply
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`declaration opinions. EX2102 illustrates that the testimony “misapplies and
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`misrepresents the evidence.” Patent Owner’s Sur-Reply, at 13-14. The Board has
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`4 It is also clear that, like many product manuals, EX2102 provides the same
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`information in different languages for the user’s convenience. As grey sidebars in
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`the manual indicate, pages 3-17 are German (“Deutsch”), pages 18-31 are English,
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`pages 32-45 are French (“Francais”), and 46-49 are Italian (“Italiano”).
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`Patent Owner’s Opposition To
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`held that just because exhibits were introduced during a deposition for the first
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`time does not preclude the Patent Owner from relying on the exhibits in a sur-
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`reply. See IPR2020-00349, Paper 53, at 12 (July 15, 2021) (PTAB admitting
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`exhibits for use in sur-reply for evaluating deposition testimony). EX2102
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`provides necessary context to evaluate Dr. Gonda’s testimony regarding an
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`“average” nebulizer output and efficiency, and because the exhibit undermines
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`the bases for Dr. Gonda’s opinions, EX2102 is admissible for at least those
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`purposes. Accordingly, the Board should deny Petitioner’s motion to exclude
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`EX2102.
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`D. EX2103: Lieberman article
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`Petitioner’s motion to exclude EX2103 should also be denied. First,
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`Petitioner asserts it “was not able to readily retrieve any article with that title
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`dated in 2006.” This strains credibility. Searching Google for “Respiratory Drug
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`Delivery 2006” readily brings any internet searcher to https://www.rddonline
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`.com/, which can be searched overall and, specifically, within the 2006
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`proceedings. It’s easy to find EX2103.
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`Petitioner also alleged that since EX2103 does not indicate that it was
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`published before the May 15, 2006 date. EX2103 is not being cited as prior art,
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`however, and the relevance of EX2103 is not limited to whether the exhibit
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`Patent Owner’s Opposition To
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`predates May 15, 2006. Moreover, “[s]tatus as a prior art printed publication is a
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`substantive issue, not an evidentiary issue.” Caterpillar, IPR2017-02187, Paper 42
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`at 17. Rather, Patent Owner relies on EX2103 for what it shows about the
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`general knowledge of the POSA around the priority date (cf. Inst. Dec. (Paper
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`No. 18) at 24) and to provide the full context of deposition testimony (as
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`discussed above regarding the other objected-to exhibits). Patent Owner’s Sur-
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`reply relies on EX2103 to impeach Dr. Gonda’s testimony (EX2099) regarding
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`his assumed efficiencies of nebulizers in general and the alleged differences
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`between jet and ultrasonic nebulizers. Patent Owner’s Sur-Reply (Paper No. 55)
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`at 15-16. EX2103 provides context necessary to evaluate the references Dr.
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`Gonda relied upon during his testimony. Id. at 16. For all of these reasons, the
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`Board should deny Petitioner’s motion to exclude EX2103.
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`III. CONCLUSION
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`For at least the response provided above, Patent Owner asks the Board to
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`deny Petitioner’s motion to exclude EX2092 (attached to EX2094 at pages 63-65),
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`EX2100, EX2101, EX2102, and EX2103. Patent Owner also requests that, if the
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`Board excludes any one of these exhibits, the Board not exclude any of the
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`arguments that cite these exhibits since each of the arguments are supported by
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`facts independent of the content of these exhibits.
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`Date: April 27, 2022
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`Patent Owner’s Opposition To
`Petitioner’s Motion to Exclude
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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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`Patent Owner’s Opposition To
` Petitioner’s Motion to Exclude
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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 Opposition To Petitioner’s Motion to Exclude, Patent Owner’s Updated
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`Exhibit List, and exhibits were served on counsel of record on April 27, 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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`
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`Date: April 27, 2022
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`
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`
`
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`
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
`
`4894-6420-3806
`
`
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