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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`GRÜNENTHAL GMBH,
`Petitioner
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`v.
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`ANTECIP BIOVENTURES II LLC,
`Patent Owner
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`Case PGR2019-00028
`U.S. Patent No. 10,052,338
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`PATENT OWNER’S MOTION TO EXCLUDE
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`DATED: April 3, 2020
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`Respectfully submitted,
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`By /R. Parrish Freeman/
` R. Parrish Freeman, Reg. No. 42,556
`pfreeman@mabr.com
`Brent A. Johnson, Reg. No. 51,851
`bjohnson@mabr.com
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`MASCHOFF BRENNAN, PLLC
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`Attorneys for Patent Owner
`ANTECIP BIOVENTURES II LLC
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`U.S. Patent No. 10,052,338
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`PGR2019-00028
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`Patent Owner moves to exclude or partially exclude the following of
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`Petitioner’s exhibits: 1004, 1006, 1007, 1008, 1009, 1010, 1038, 1040, 1043, 1044,
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`1045, 1046. Exhibits numbered 1040 and higher were first present with the Reply.
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`I.
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`Patent Owner timely filed and served objections to the subject exhibits.
`Patent Owner objected to Exs. 1004, 1006–1010, and 1038 in Paper 8 (Sept.
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`3, 2019), and to Exs. 1040 and 1043–1046 in Paper 15 (Jan. 21, 2020).
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`II. Exhibit 1004 (Poree Declaration)
`Patent Owner requests exclusion of those parts of the Poree Declaration (Ex.
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`1004) that rely on Varenna 2011 (Ex 1006), Muratore (Ex. 1007), Gatti (Ex. 1008),
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`Harden (Ex. 1009), and/or Drummond (Ex. 1010) in opining that the claims of the
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`’338 patent would have been obvious and are therefore unpatentable. Petitioner
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`relies upon Dr. Poree’s obviousness opinions throughout its Petition and Reply to
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`support Grounds 1 and 3. Rule 703, Fed. R. Evid., allows that “[i]f experts in the
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`particular field would reasonably rely on those kinds of facts or data in forming an
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`opinion on the subject, they need not be admissible for the opinion to be admitted,”
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`while Rule 702(b) requires expert testimony be “based on sufficient facts or data.”
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`None of the multiple references cobbled together by Dr. Poree to reach his
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`obviousness conclusions is admissible under the Federal Rules of Evidence (as
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`discussed below), which govern these proceedings. 37 C.F.R. § 42.62(a). Dr. Poree
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`cites to and relies upon all these references but fails to testify that experts in the
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`field would reasonably rely on such sources, or on the facts or data they allegedly
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`contain, in forming an opinion on the subject. No other evidence in the record
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`proves that other experts would so rely. All of Dr. Poree’s obviousness conclusions
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`are based on these inadmissible references and all of his obviousness opinions
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`should be excluded accordingly under Rule 702(b) and 703.
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`III. Exhibit 1006 (Varenna 2011)
`Patent Owner requests exclusion of at least the date information appearing
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`on the face of Varenna 2011 (Ex. 1006). Petitioner relies on Varenna 2011 to prove
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`obviousness in connection with Grounds 1 and 3 throughout both the Petition and
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`the Reply, and specifically cites the date information at p. 28 of the Petition. Dr.
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`Poree cites the date information at ¶ 40 of his declaration (Ex. 1004). Petitioner
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`treats the date information as testimony to establish the fact of publication and the
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`legal conclusion that Varenna 2011 is a printed publication under 35 U.S.C.
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`§ 102(a). Specifically, Petitioner asks the Board to accept these statements
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`appearing on the face of Varenna 2011 as truthful testimony, despite being words
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`on a page and not the testimony of a declarant testifying under oath in connection
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`with the present trial: “OTTOBRE 2011”, “ARTICOLO ORGINALE”, “Ricevuto
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`il 15 luglio 2011”, and “Accettato il 30 agosto 2011.” These statements constitute
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`hearsay under Fed. R. Evid. 801 and are inadmissible under Fed. R. Evid. 802.
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`IV. Exhibit 1007 (Muratore)
`Patent Owner requests exclusion of at least the date information appearing
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`on the face of Muratore (Ex. 1007). Petitioner relies on Muratore to prove
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`obviousness in connection with Grounds 1 and 3 throughout both the Petition and
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`the Reply, and specifically cites the date information at p. 32 of the Petition. Dr.
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`Poree cites the date information at ¶ 50 of his declaration (Ex. 1004). Petitioner
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`treats the date information as testimony to establish the fact of publication and the
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`legal conclusion that Muratore is a printed publication under 35 U.S.C. § 102(a).
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`Specifically, Petitioner asks the Board to accept these statements appearing on the
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`face of Muratore as truthful testimony, despite being words on a page and not the
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`testimony of a declarant testifying under oath in connection with the present trial:
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`“S/2004”, “2004-07-19”, “Volume 5”, “Supplemento 1/2004”, “2004 ISSUE 1
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`SUPPLEMENT”, and “Maratea (PZ), 16-18 aprile 2004.” These statements
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`constitute hearsay under Fed. R. Evid. 801 and are inadmissible under Fed. R.
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`Evid. 802.
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`V. Exhibit 1008 (Gatti)
`Patent Owner requests exclusion of at least the date information appearing
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`on the face of Gatti (Ex. 1008). Petitioner relies on Gatti to prove obviousness in
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`connection with Grounds 1 and 3 throughout both the Petition and the Reply, and
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`specifically cites the date information at p. 31 of the Petition. Dr. Poree cites the
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`date information at ¶ 46 of his declaration (Ex. 1004). Petitioner treats the date
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`information as testimony to establish the fact of publication and the legal
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`conclusion that Gatti is a printed publication under 35 U.S.C. § 102(a).
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`Specifically, Petitioner asks the Board to accept these statements appearing on the
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`face of Gatti as truthful testimony, despite being words on a page and not the
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`testimony of a declarant testifying under oath in connection with the present trial:
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`“Published online: 17 Sep 2009” and “© 2009 Inform UK Ltd.” These statements
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`constitute hearsay under Fed. R. Evid. 801 and are inadmissible under Fed. R.
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`Evid. 802.
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`VI. Exhibit 1009 (Harden)
`Patent Owner requests exclusion of at least the date information appearing
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`on the face of Harden (Ex. 1009). Petitioner relies on Harden to prove obviousness
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`in connection with Grounds 1 and 3 throughout both the Petition and the Reply,
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`and specifically cites the date information at pp. 26–27 of the Petition. Dr. Poree
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`cites the date information at ¶ 61 of his declaration (Ex. 1004). Petitioner treats the
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`date information as testimony to establish the fact of publication and the legal
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`conclusion that Harden is a printed publication under 35 U.S.C. § 102(a).
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`Specifically, Petitioner asks the Board to accept these statements appearing on the
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`face of Harden as truthful testimony, despite being words on a page and not the
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`testimony of a declarant testifying under oath in connection with the present trial:
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`“PAIN 150 (2010) 268-274”, “Received 18 November 2009”, “Received in revised
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`form 19 March 2010”, “Accepted 20 April 2010”, and “© 2010 International
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`Association for the Study of Pain.” These statements constitute hearsay under Fed.
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`R. Evid. 801 and are inadmissible under Fed. R. Evid. 802.
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`VII. Exhibit 1010 (Drummond)
`Patent Owner requests exclusion of at least the date information appearing
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`on the face of Drummond (Ex. 1010). Petitioner relies on Drummond to prove
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`obviousness in connection with Ground 3 throughout both the Petition and the
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`Reply, and specifically cites the date information at p. 56 of the Petition. Dr. Poree
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`cites the date information at ¶ 72 of his declaration (Ex. 1004). Petitioner treats the
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`date information as testimony to establish the fact of publication and the legal
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`conclusion that Drummond is a printed publication under 35 U.S.C. § 102(a).
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`Specifically, Petitioner asks the Board to accept this statement appearing on the
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`face of Drummond as truthful testimony, despite being words on a page and not the
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`testimony of a declarant testifying under oath in connection with the present trial:
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`“Pain Medicine 2010.” This statement constitutes hearsay under Fed. R. Evid. 801
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`and is inadmissible under Fed. R. Evid. 802.
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`VIII. Exhibit 1038 (GIOT website printout)
`Exhibit 1038 should be excluded as irrelevant. Petitioner relies on Ex. 1038
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`as providing facts supportive of a legal conclusion that Varenna 2011 (Ex. 1006)
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`qualifies as a printed publication under 35 U.S.C. § 102(a). (Pet., 27.) Dr. Poree
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`cites Ex. 1038 for the same purpose. (Ex. 1004, ¶ 40.) The document shows it was
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`printed on January 2, 2019 and also shows an upload date (allegedly for Varenna
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`2011) of June 1, 2015. Petitioner cites May 14, 2012, as the date to beat for
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`proving printed publication status. (Reply, 4.) Exhibit 1038 thus constitutes
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`evidence having no tendency to make a fact of consequence more or less probable
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`than it would be without Exhibit 1038. Since Petitioner purports it to be nothing
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`more than a copy of a page from the GIOT website as it appeared on January 2,
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`2019, showing an article that was uploaded on June 1, 2015, it has no bearing upon
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`the determination of what a POSA would have known before the priority date of
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`May 14, 2012. This document is therefore irrelevant under Fed. R. Evid. 401 and
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`inadmissible under Fed. R. Evid. 402.
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`IX. Reply Exhibits 1040, 1043, 1044, 1045, 1046
`Petitioner first submitted Exhibits 1040 and 1043–1046 with its Reply. The
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`Board should exclude them as untimely evidence that Petitioner could have
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`included with the Petition, in that each purports to establish facts necessary for
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`Petitioner to make a prima facie showing that Exs. 1006 (Varenna 2011), 1007
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`(Muratore), and 1008 (Gatti) qualify as “printed publication” prior art under 35
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`U.S.C. § 102(a). Petitioner elected to present no evidence with the Petition to show
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`that Gatti and Muratore qualify as printed publications under the law, whether by
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`dissemination or by being otherwise made available such that a person of ordinary
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`skill in the art exercising reasonable diligence could have located them. Exhibits
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`1043 and 1044 are substantive declarations attempting to cure that deficiency, but
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`Petitioner simply filed them with its Reply without seeking leave to do so under 37
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`C.F.R. § 42.223. It is a violation of rules 42.223, 42.23(b), and the Consolidated
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`Trial Practice Guide for Petitioner to present such evidence for the first time in its
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`Reply. 37 C.F.R. § 42.23(b) (authorizing responsive argument, not evidence); 37
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`C.F.R. § 42.223 (requiring motion in order to augment record with supplemental
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`information); Consol. Trial Practice Guide, § II.I., pp. 73-75 (Nov. 2019)
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`(hereinafter, “Guide” (https://www.uspto.gov/about-us/news-updates/consolidated-
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`trial-practice-guide-november-2019)) (“Examples of indications that a new issue
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`has been raised in a reply include new evidence necessary to make out a prima
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`facie case for the patentability or unpatentability of an original or proposed
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`substitute claim.”). Exhibits 1043 and 1044 should be excluded or disregarded
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`accordingly.
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`Reply Exhibits 1040, 1045, and 1046 should be excluded for the same
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`reason, but with a slight difference. Each purports to support the printed
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`publication status of Varenna 2011 (Ex. 1006), but Petitioner also provided Ex.
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`1038 with the Petition itself. Petitioner provided no argument in the Petition as to
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`whether its theory was dissemination, or availability, or some combination, but
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`given the nature of Ex. 1038—a web page allegedly making Varenna 2011
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`available—it is evident that Petitioner’s theory was availability rather than
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`dissemination. Petitioner changed its theory to dissemination in its Reply (at 11 n.
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`3) and filed Exs. 1040, 1045, and 1046 for support, without seeking or obtaining
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`prior leave to do so under 37 C.F.R. § 42.223. The dissemination theory for
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`Varenna 2011 was brand new to the Reply and that entire argument should be
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`disregarded for that reason alone. E.g., Samsung Elecs. Co. Ltd. v. Ibex PT
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`Holdings Co., Ltd., No. IPR2018-00095, slip op. at 21-22 (PTAB Apr. 30, 2019)
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`(Paper 30). But there is no question that the new evidence in support of that new
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`theory should be excluded. 37 C.F.R. § 42.23(b); Guide, 74 (“‘Respond,’ in the
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`context of 37 C.F.R. § 42.23(b), does not mean proceed in a new direction with a
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`new approach as compared to the positions taken in a prior filing. While replies
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`and sur-replies can help crystalize issues for decision, a reply or sur-reply that
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`raises a new issue or belatedly presents evidence may not be considered.”) “It is of
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`the utmost importance that petitioners in the IPR proceedings adhere to the
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`requirement that the initial petition identify ‘with particularity’ the ‘evidence that
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`supports the grounds for the challenge to each claim.’” Intelligent Bio-Systems,
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`Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35
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`U.S.C. § 312(a)(3)).
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`Patent Owner is aware of no case in which a panel or a court has
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`intentionally endorsed presenting evidence and argument to support a printed
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`publication showing in the first instance in an IPR, PGR, or CBM reply. To the
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`contrary, cases like Samsung, cited above, and Telefonaktiebolaget LM Ericsson v.
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`TCL Corp., 941 F.3d 1341 (Fed Cir. 2019), illustrate the right way for a petitioner
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`to amplify the record to address a weak “printed publication” showing. Present the
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`argument and evidence in the petition then, if trial is instituted, timely ask to add
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`more evidence to support a printed publication showing by filing a motion
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`pursuant to rule 42.123 (IPR) or 42.223 (PGR). See Samsung at 9;1
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`Telefonaktiebolaget, 941 F.3d at 1345. That way, the patent owner has notice of
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`the argument to allow it to substantively respond, and also has a clear picture of the
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`supporting evidence in time for it to consider and address in the patent owner
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`response. What Petitioner did in this case was to say nothing in the Petition of what
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`theory supports printed publication status, so Patent Owner could not directly
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`respond in the Patent Owner Response. Petitioner instead withheld its substantive
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`argument and supporting evidence until its Reply, that is, after the Patent Owner
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`Response. So Patent Owner spent all of the pretrial period and the bulk of the trial
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`period focused on dealing with a record that was incomplete due solely to
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`Petitioner’s withholding of evidence and argument. As the Guide and the
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`authorities cited therein make clear, the reply is not the time for a petitioner to raise
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`its printed publication argument and evidence for the first time. Guide, 73-75. It is
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`1 See also these Board decisions related the cited Samsung decision: IPR2018-
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`00011 at 8-9; IPR2018-00012 at 3; IPR2018-00092 at 9; IPR2018-00093 at 9;
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`IPR2018-00094 at 9.
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`profoundly unfair to require Patent Owner to pivot and fully address a mass of new
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`evidence with depositions and other expenses required for a fulsome response—in
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`the Sur-Reply. The schedule entered in this and every other IPR and PGR
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`proceeding contemplates essentially no time for that kind of work. The schedule in
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`this case allows three months after trial starts to allow Patent Owner to fully
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`address and respond to Petition evidence and argument in preparing its Patent
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`Owner Response, but only one month to prepare the Sur-Reply responsive to the
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`Reply. That one month is in fact only two weeks of a “discovery period” after time
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`for objections and supplemental evidence are removed. 37 C.F.R. § 42.53(d)(2). To
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`expect any patent owner to make its case against arguments and evidence
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`necessary to prove printed publication status but withheld by the petitioner until
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`the reply brief, that is, at the end of trial and after principal briefing has concluded,
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`is unfair and incompatible with statutory and regulatory scheme. The Board should
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`therefore exclude the Reply Exhibits 1040 and 1043–1046.
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`X. Reply Exhibit 1040 (second GIOT website printout)
`The Board should exclude Reply Exhibit 1040 because it constitutes
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`evidence having no tendency to make a fact of consequence more or less probable
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`than it would be without the evidence. Petitioner concedes that it is not relying on
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`Internet publication of Varenna 2011 (Ex. 1006), as allegedly evidence by Ex.
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`1038, and is instead “relying on the actual printing and circulation of the journal
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`issue to establish Varenna 2011 as prior art.” (Reply, 11 n. 3.) Exhibit 1040 states
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`nothing about actual printing or circulation, nor does it suggest anything about
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`whether or how a person of ordinary skill in the art could have located Varenna
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`2011 (Ex. 1006) before the priority date. This document is therefore irrelevant
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`under Fed. R. Evid. 401 and inadmissible under Fed. R. Evid. 402.
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`XI. Reply Exhibit 1043 (Canady Declaration)
`The Board should exclude Reply Exhibit 1043 because it constitutes
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`evidence having no tendency to make a fact of consequence more or less probable
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`than it would be without the evidence. The declarant’s retrieval of the Muratore
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`reference (Ex. 1007) from a library in December 2017, many years after the
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`priority date for the patent at issue, has no bearing upon whether Muratore was
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`disseminated or otherwise available to the public such that persons of ordinary skill
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`in the art exercising reasonable diligence could have located it before the priority
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`date. In addition, the declarant represents himself to be a specialist in “document
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`retrieval and delivery of medical and biomedical articles obtained from the
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`National Institutes of Health National Library of Medicine” and does not purport to
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`convey any information about the ability of reasonably diligent persons of ordinary
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`skill in the art pertaining to the patent at issue, and lacking his level of research
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`expertise. The declarant does not purport to be a person having ordinary skill in the
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`art of the patent at issue, or to have an understanding of the knowledge of such a
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`person. Furthermore, the ability to locate or retrieve a reference by name is not
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`relevant to whether a person of ordinary skill in the art researching the subject
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`matter could have located the reference before the priority date. The declarant
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`provides no information to suggest that he or any other person could have located
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`the reference using a subject matter search. The declarant does not testify that the
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`NLM was a resource to which persons of ordinary skill in the art would have
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`turned before the priority date when researching the subject matter of the patent at
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`issue. The declarant does not provide any information about the library’s
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`cataloguing and indexing system other than to state that he “requested the specific
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`issue containing Muratore.” None of this information tends to make it any more
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`likely that Muratore was accessible before the priority date such that reasonably
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`diligent persons of ordinary skill in the art could have located it when researching
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`the subject matter. This document is therefore irrelevant under Fed. R. Evid. 401
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`and inadmissible under Fed. R. Evid. 402.
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`Reply Exhibit 1043 also includes matters beyond the witness’s personal
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`knowledge. The declarant speculates at ¶ 7, for example, as to the meaning of the
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`library’s markings applied to the reference. The declarant admits his testimony is
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`based on inference and not on first-hand information. The declarant does not state,
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`for example, that he has worked for the library, or read any of its policies vis-à-vis
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`date stamps and intake and shelving, or had any conversations with any person
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`having such knowledge. It is pure speculation to then declare that Muratore or
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`other date-stamped materials are “added to the NLM’s General Collection—and
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`therefore available and accessible to the public … within 7-10 days of receipt of
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`the publication.” Such testimony is made without personal knowledge and is
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`inadmissible under Red. R. Evid. 602.
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`XII. Reply Ex. 1044 (Militello Declaration)
`The Board should exclude Reply Exhibit 1044 because it constitutes
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`evidence having no tendency to make a fact of consequence more or less probable
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`than it would be without the evidence. Nothing in the declaration, including the
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`testimony that Gatti (Ex.1008) was posted to a website, tends to show that the
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`reference was meaningfully indexed such that an interested artisan exercising
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`reasonable diligence before the priority date would have found it. Nothing in the
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`declaration tends to show that the website was one to which persons of ordinary
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`skill in the art would have turned when researching the subject matter of the patent
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`at issue before the priority date. The declarant does not purport to be a person
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`having ordinary skill in the art of the patent at issue, or to have an understanding of
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`the knowledge of such a person, and thus cannot convey any information about the
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`ability of reasonably diligent persons of ordinary skill in the art to locate Gatti
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`before the priority date. Nothing in the testimony tends to make any more or less
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`probable that Gatti was accessible before the priority date such that persons of skill
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`in the art could have located it when researching the subject matter. This document
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`is therefore irrelevant under Fed. R. Evid. 401 and inadmissible under Fed. R.
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`Evid. 402.
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`XIII. Reply Exhibits 1045 (Tarquini Declaration) and 1046 (Translation)
`The Board should exclude Reply Exhibit 1045, the Italian language
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`document attached as Exhibit 1 thereto, and the English translation of that
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`document (Reply Ex. 1046). For purposes of this motion, the Italian language
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`document and its English translation are treated as the same document, referred to
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`hereinafter as the “Pacini document.” Reply Exhibit 1045 and the Pacini document,
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`which both purport to be declarations, constitute evidence having no tendency to
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`make a fact of consequence more or less probable than it would be without the
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`evidence. The declarants do not purport to be persons having ordinary skill in the
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`art of the patent at issue, or to have an understanding of the knowledge of such a
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`person, and thus cannot convey any information about the ability of reasonably
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`diligent persons of ordinary skill in the art to locate Varenna 2011 (Ex. 1006)
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`before the priority date. The testimony purports to present evidence of the
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`dissemination of Varenna 2011, but provides none of the information required to
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`support a showing of accessibility via dissemination, such as evidence that it was
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`publicized or placed in front of the interested public. Neither declarant provides
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`any testimony, for example, that the reference was announced, read, or handed out
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`at the conference, or that the publisher’s booth was positioned such that
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`conference-goers would visit it, or that the conference attendees would understand
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`the teachings of the reference. Nothing in the testimony tends to make any more or
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`less probable that Varenna 2011 was disseminated before the priority date. This
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`document is therefore irrelevant under Fed. R. Evid. 401 and inadmissible under
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`Fed. R. Evid. 402.
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`The Pacini document also constitutes inadmissible hearsay. Specifically, it
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`purports to be a declaration but is not made by an individual, but rather by a
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`company, and is not signed under oath and does not qualify as a sworn declaration
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`or affidavit under United States law (28 U.S.C. § 1746). It is a statement not made
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`by a declarant testifying under oath in connection with the present trial that
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`Petitioner offers in evidence to prove the truth of the matter asserted in the
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`statement. The statement in Pacini document was made by an unsworn and
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`unidentified out-of-court declarant and constitutes hearsay under Fed. R. Evid. 801
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`and is inadmissible under Fed. R. Evid. 802.
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6, I hereby certify that on this 3rd day of April,
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`2020, the foregoing PATENT OWNER’S MOTION TO EXCLUDE was served
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`via electronic mail on the following counsel of record for Petitioner.
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`Daniel J. Minion (Reg. No. 53,329)
`Bruce C. Haas (Reg. No. 32,734)
`Katherine E. Adams (Reg. No. 73,758)
`VENABLE LLP
`1290 Avenue of the Americas
`New York, NY 10104
`Telephone: (212) 218-2290
`Facsimile: (212) 218-2200
`dminion@venable.com
`bchaas@venable.com
`keadams@venable.com
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`By: /R. Parrish Freeman/
`R. Parrish Freeman, Reg. No. 42,556
`MASCHOFF BRENNAN, PLLC
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