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
`
`
`PETITIONER’S MOTION TO EXCLUDE
`EXHIBITS 2092, 2100, 2101, 2102, AND 2103
`
`
`
`
`
`
`
`
`
`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 MOTION TO EXCLUDE
`EXHIBITS 2092, 2100, 2101, 2102, AND 2103
`
`
`
`
`
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`I.
`
`INTRODUCTION
`
`Petitioner’s Motion to Exclude
`
`Petitioner moves to exclude Patent Owner’s Exhibits 2092, 2100, 2101, 2102,
`
`and 2103 under 37 C.F.R. § 42.64(c) and the Scheduling Order (Paper 19) on the
`
`following grounds:
`
`Exhibit
`
`Description
`
`Reason to Exclude
`
`EX2092 (attached
`to EX2094 at 63-
`65)
`EX2100
`
`EX2101
`
`EX2102
`
`EX2103
`
`British Library Communication
`from Rupert Lee
`
`Incomplete document;
`not authenticated
`
`Schill: Multisonic, Inhaling
`with ultrasonic infraControl,
`Instructions for Use (2004)
`Schill: Multisonic, Inhaling
`with ultrasonic infraControl,
`Instructions for Use
`DeVilbiss, UltraNeb,
`Ultrasonic Nebulizer User
`Manual
`Lieberman, et al., In Vitro
`Performance of the MyNeb™
`Nebulizer: A New Portable
`Aerosol Delivery System
`
`Not authenticated (no
`date or origin
`information)
`Not authenticated (no
`date or origin
`information)
`Not authenticated (no
`date or origin
`information)
`Not authenticated (no
`date or origin
`information)
`
`Patent Owner relied on these exhibits in its Sur-Reply (Paper 55), and thus,
`
`Petitioner also moves to exclude the portions of Patent Owner’s Sur-Reply that rely
`
`on these exhibits.
`
`1
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`II. PETITIONER TIMELY OBJECTED
`
`Petitioner’s Motion to Exclude
`
`a. EX2092: British Library Communication
`
`Petitioner timely objected to EX2092, attached to EX2094 at pages 63-65,
`
`under Federal Rule of Evidence (“FRE”) 106 and 901. Paper 56 at 2. As explained
`
`below, the supplemental evidence filed did not adequately address these objections.
`
`Thus, this exhibit should be excluded under each of these rules.
`
`b. EX2100-2103: Schill, DeVilbiss, and Liebermann
`
`Petitioner timely objected to EX2100-2103 under FRE 901, as there is no
`
`indication about the origins or dates of public availability for these documents.
`
`Paper 56 at 4. As explained below, the supplemental evidence filed did not
`
`adequately address these objections. Thus, these exhibits should be excluded under
`
`this rule.
`
`III. ARGUMENT
`
`a. EX2092: British Library Communication
`
`EX2092, attached to EX2094 at pages 63-65, is an incomplete email chain
`
`containing two emails. One email is from a Rupert Lee to a Jim DiNatale that was
`
`“[i]n answer to . . . questions” that seem to have been deliberately excluded from the
`
`exhibit, since the subject line of Mr. Lee’s email is “RE: Questions about journal,”
`
`where “RE” generally indicates a reply to a prior e-mail in the same chain. The
`
`second email in the chain is from Mr. DiNatale forwarding the email to Mr. Maebius.
`
`2
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`Both emails are dated in 2018 and do not appear to have been procured in relation
`
`Petitioner’s Motion to Exclude
`
`to this matter, which was initiated in 2021.
`
`Because the underlying email with the questions Mr. DiNatale posed to Mr.
`
`Lee are not included, it is not clear if Mr. DiNatale was answering questions about
`
`the British Library’s practices as of 2018, or as of the priority date of the ’793 patent
`
`in 2006. Further, Mr. Lee does volunteer that the “main reading rooms in London”
`
`have “searching and browsing facilities available” (EX2094 at 64-65 (EX2092 at 1-
`
`2)) but Patent Owner chose to ignore that in its Sur-Reply, and Petitioner had no
`
`papers left to address the issue.
`
`Patent Owner raised this exhibit for the first time in the second deposition of
`
`Dr. Hall-Ellis (EX2094, conducted on 3/11/2022), even though Dr. Hall-Ellis had
`
`no reason to have seen the exhibit before or have knowledge of its origins or
`
`contents.
`
`The only supplemental evidence Patent Owner provided to attempt to cure
`
`these deficiencies is a declaration from Mr. DiNatale, who is a “Research Librarian”
`
`at Patent Owner’s counsel’s law firm, Foley & Lardner LLP. The declaration
`
`provides no details as to exactly what questions led to the response in EX2092. In
`
`fact, the declaration states that Mr. DiNatale spoke to British Library employee
`
`Seema Rampersad, who provided signed letters in this proceeding (EX1116 and
`
`3
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`EX1119) and whom Petitioner made available for deposition, but whose deposition
`
`Petitioner’s Motion to Exclude
`
`Patent Owner cancelled the night before.
`
`EX2092 appears to be Patent Owner attempting to get specific, undated,
`
`incomplete, out-of-context information into the proceeding, to somehow undermine
`
`the signed letters of British Librarian Ms. Rampersad (EX1116 and EX1119) and
`
`the signed declarations of library expert Dr. Hall-Ellis (EX1036 and EX1112), both
`
`prepared for this proceeding.
`
`Accordingly, EX2092 should be excluded under FRE 106, because it is an
`
`incomplete document, where all of the prior email correspondence between the
`
`British Library contact and Patent Owner’s counsel appear to be deleted.
`
`Additionally, EX2092 should be excluded under FRE 901 because there is
`
`insufficient evidence to support a finding that the exhibit is what Patent Owner
`
`claims it is: it is unclear in what context this email originated (in part because the
`
`email chain is incomplete), in what capacity the British Library contact is
`
`responding, and is an unsigned email thread that was modified by Patent Owner’s
`
`counsel (as evidenced by the deletion of the correspondence containing the questions
`
`to which Mr. Lee was responding).
`
`4
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`b. EX2100 and 2101: Schill Instructions for Use
`
`Petitioner’s Motion to Exclude
`
`EX2100 appears to be a “Schill: Multisonic, Inhaling with ultrasonic
`
`infraControl, Instructions for Use,” but is undated and there is no indication about
`
`the origins or dates of public availability of the document.
`
`EX2101 appears to be another “Schill: Multisonic, Inhaling with ultrasonic
`
`infraControl, Instructions for Use,” but is similarly undated and there is no indication
`
`about the origins or dates of public availability of the document.
`
`The supplemental evidence that Patent Owner provided to attempt to cure
`
`these deficiencies is a declaration from an Internet Archive employee, Nathaniel E.
`
`Frank-White, dated April 5, 2022. But Patent Owner has challenged the sufficiency
`
`of similar Internet Archive declarations in establishing the origins or dates of public
`
`availabilities of a document. See Paper 55 at 11-12 n.5; see generally EX2095
`
`(Patent Owner deposing Internet Archive representative offered by Petitioner to
`
`testify on EX1087 and EX1115). Accordingly, to the extent the Board finds that the
`
`proffered Internet Archive declarations by Petitioner (EX1087 and EX1115) is
`
`insufficient evidence of the origins and/or dates of public availability of the
`
`documents, Petitioner asks that EX2100 and EX2101 be excluded under FRE 901.
`
`Additionally, Mr. Frank-White’s declaration provides no pathway as to how
`
`a POSA would be able to find EX2100 or EX2101 as of 2006. Petitioner did not
`
`have an opportunity to depose Mr. Frank-White (because EX2100 and EX2101 were
`
`5
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`filed with the Sur-Reply and the related supplemental evidence was served
`
`Petitioner’s Motion to Exclude
`
`afterwards) to determine where and how he sourced the documents attached to his
`
`declaration and if they are the same as EX2100 and EX2101. For this additional
`
`reason, Petitioner asks that EX2100 and EX2101 be excluded under FRE 901.
`
`c. EX2102: DeVilbiss, UltraNeb, Ultrasonic Nebulizer User Manual
`
`EX2102 appears to be a “DeVilbiss, UltraNeb, Ultrasonic Nebulizer User
`
`Manual,” but is undated and there is no indication about the origins or dates of public
`
`availability of the document. Large chunks of the document are in language(s) that
`
`are not English. The document was raised for the first time at the 3/14/22 deposition
`
`of Dr. Gonda (EX2099), without establishing that Dr. Gonda had ever seen the
`
`document before or could understand the full contents. The exhibit was then filed
`
`with the Sur-Reply, without any opportunity for Petitioner to investigate its origins
`
`or public availability as of 2006.
`
`The supplemental evidence that Patent Owner provided to attempt to cure
`
`these deficiencies is a declaration from Patent Owner’s counsel, who simply
`
`provided
`
`the URL
`
`from which he accessed
`
`the document
`
`in 2022
`
`(https://www.manualslib.com/manual/1100004/Devilbiss-Ultraneb.html), which
`
`does not provide any evidence that the document was available before May 2006.
`
`Further, the declaration provides no details as to what this “manualslib” website is,
`
`why it would be a reliable source of information, or how Patent Owner’s counsel is
`
`6
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`qualified to attest to that fact—it certainly does not appear to be the manufacturer’s
`
`Petitioner’s Motion to Exclude
`
`website.
`
`There is no evidence as to the authenticity or date of EX2102, and thus, it
`
`should be excluded under FRE 901. Xactware Sols., Inc. v. Pictometry Int’l Corp.,
`
`IPR2016-00594, 2017 WL 3671031, Paper 46 (Final Written Decision) at *4-5
`
`(P.T.A.B. Aug. 24, 2017) (excluding purported slide presentation despite declaration
`
`that presentation was downloaded from particular website because “[p]rintouts from
`
`websites are not self-authenticating” and no explanation as to how or why document
`
`was stored on website), aff’d, 742 Fed. App’x 509 (Fed. Cir. 2018); Nevro Corp. v.
`
`Boston Sci. Neuromodulation Corp., IPR2017-01812, Paper 79 (Final Written
`
`Decision) at 84 (P.T.A.B. Feb. 1, 2019) (“undated” exhibit and “cited testimony
`
`concerning” the exhibit “does not speak to a POSITA’s understanding of the
`
`components of such a device, at the critical date”).
`
`a. EX2103: Lieberman article
`
`EX2103 appears to be an article by “Lieberman, et al.” titled “In Vitro
`
`Performance of the MyNeb™ Nebulizer: A New Portable Aerosol Delivery
`
`System.” The document contains a line “Respiratory Drug Delivery 2006,” but does
`
`not indicate if it was published before the priority date of May 15, 2006. See Nevro
`
`Corp., Paper 79 at 84. Further, Petitioner was not able to readily retrieve any article
`
`with that title dated in 2006.
`
`7
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`Petitioner’s Motion to Exclude
`
`Despite Petitioner’s objections, Patent Owner took no action and failed to
`
`serve any supplemental evidence relating to EX2103. Accordingly, EX2103 should
`
`be excluded.
`
`IV. CONCLUSION
`
`For at least the reasons provided above, Petitioner asks the Board to grant this
`
`motion and exclude EX2092 (attached to EX2094 at pages 63-65), EX2100,
`
`EX2101, EX2102, and EX2103.
`
`If the Board excludes these exhibits, Petitioner also requests that the Board
`
`exclude Patent Owner’s arguments in its Sur-Reply that rely on these exhibits and
`
`rely on Dr. Gonda or Dr. Hall-Ellis’s testimony related to these exhibits.
`
`Specifically, the portions of the Sur-Reply (Paper 55) are:
`
` P.8: “another librarian at the British Library” to “the Abstracts themselves
`
`were not available unless patrons somehow had the specific citations.”
`
` P. 8-9: “Those printed indices” to “available (EX2094, 64).”
`
` P. 14: “Discrepancies” to “dose rate).”
`
` P. 15: “Indeed, Dr. Gonda agreed” to “EX2197, 173:19-174:9”
`
` P. 16: “But if the” to “EX2100, 28;”
`
` P.16: “Lieberman 2006” to “respectively.”
`
`
`
`8
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`
`Dated: April 20, 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 Motion to Exclude
`
`
`
`By:
`
`
`
`
`
`/Erik B. Milch/
`Erik B. Milch
`Reg. No. 42,887
`Counsel for Petitioner
`
`9
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`Petitioner’s Motion to Exclude
`
`CERTIFICATE OF SERVICE
`foregoing
`the
`The undersigned hereby certifies
`that a copy of
`PETITIONER’S MOTION TO EXCLUDE EXHIBITS 2092, 2100, 2101, 2102,
`AND 2103 was served on counsel of record on April 20, 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 20, 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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