Paper 38
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`AQUESTIVE THERAPEUTICS, INC.
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`
`Petitioner
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`v.
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`NEURELIS, INC.
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`Patent Owner
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`_______________________
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`Case: IPR2019-00451
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`U.S. Patent No. 9,763,876
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`______________________
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`
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`PETITIONER’S OPPOSITION TO
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`AQUESTIVE THERAPEUTICS, INC.
`
`
`Petitioner
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`v.
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`NEURELIS, INC.
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`Patent Owner
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`_______________________
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`Case: IPR2019-00451
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`U.S. Patent No. 9,763,876
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`______________________
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`
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`PETITIONER’S OPPOSITION TO
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`TABLE OF CONTENTS
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`I.
`INTRODUCTION ............................................................................................. 1
`II. ARGUMENT ..................................................................................................... 1
`A. EX1009, EX1017, EX1021, EX1022, EX1033, EX1036, EX1038,
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`EX1048, and EX1065. ........................................................................................... 1
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`B. EX1013. ......................................................................................................... 1
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`C. EX1041, paragraphs 29-63, 167-168, 171-191, 264-362, and Appendix A
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`(pp. 197-224). ......................................................................................................... 2
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`D. EX1050. ......................................................................................................... 3
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`E. EX1069. ......................................................................................................... 3
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`F. EX1080. ......................................................................................................... 6
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`G. EX1081. ......................................................................................................... 6
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`H. EX1122 .......................................................................................................... 7
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`I.
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`EX1150. ......................................................................................................... 8
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`1. EX1150 should not be excluded in its entirety. ......................................... 8
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`2. EX1150, paragraphs 23-30, 59-89, 90-126, 146, 171-177, 191-194, and
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`208 should not be excluded. ............................................................................... 9
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`J.
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`EX1149 portions. .........................................................................................12
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`K. Limiting Request Under FRE 105 ...............................................................14
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`III. CONCLUSION ..............................................................................................14
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`I.
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`INTRODUCTION
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`U.S. Patent No. 9,763,876
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`Pursuant to the Board’s Scheduling Order (Paper 9), Petitioner Aquestive
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`Therapeutics, Inc. submits this opposition to Patent Owner’s (“PO’s”) Motion to
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`Exclude Evidence (Paper 35).
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`II. ARGUMENT
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`A. EX1009, EX1017, EX1021, EX1022, EX1033, EX1036, EX1038,
`EX1048, and EX1065.
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`EX1009, EX1017, EX1021, EX1022, EX1033, EX1036, EX1038, EX1048,
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`and EX1065 were proffered as evidence relevant to the broad state of the prior art.
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`If PO filed a Motion to Amend, PO would have had to consider that art. However,
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`PO did not file a Motion to Amend. The challenged exhibits are relevant to the
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`state of the art and not confusing, wasteful, or prejudicial and should not be
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`excluded.
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`B. EX1013.
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`EX1013 (Sonne) provides relevant disclosures regarding the state of the
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`prior art, as testified by Petitioner’s expert Dr. Peppas, and it was part of the file
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`history of the ‘876 patent. See, e.g., PeppasDec. EX1041, ¶¶ 169-191 (“Summary
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`of the Prior Art References”). “Art can legitimately serve to document the
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`knowledge that skilled artisans would bring to bear in reading the prior art
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`identified as producing obviousness. . . . . Ariosa's Petitions and opening
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`declarations invoked Exhibit 1010 in that way. . . . Given those references in the
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`Petitions and supporting declarations, Exhibit 1010 had to be considered by the
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`U.S. Patent No. 9,763,876
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`Board even though it was not one of the three pieces of prior art presented as the
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`basis for obviousness.” Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d
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`1359, 1365 (Fed. Cir. 2015).”
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`C. EX1041, paragraphs 29-63, 167-168, 171-191, 264-362, and
`Appendix A (pp. 197-224).
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`Paragraphs 29-63, 167-168, 171-191, 264-362, and Appendix A
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`(pp. 197-224) of Peppas Declaration, EX1041 should not be excluded.
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`EX1041, ¶¶29-63 discuss the ‘876 patent and its prosecution history,
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`including, priority claims, the prior art cited during prosecution, and statements
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`regarding criticality therein and elsewhere.
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`EX1041, ¶¶167-168 discuss the understanding that a POSA would have
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`regarding dodecyl maltoside, supported by public information (see previous
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`paragraphs) involving one of the co-inventors of the ‘876 patent.
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`EX1041, ¶¶171-191 discuss Sonne (Exhibit 1013) and “document the
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`knowledge that skilled artisans would bring to bear in reading the prior art
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`identified as producing obviousness.” Genzyme Therapeutic Prod. Ltd. v. Biomarin
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`Pharm. Inc., 825 F.3d 1360, 1369 (Fed. Cir. 2016) (quoting Ariosa Diagnostics v.
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`Verinata Health, Inc., 805 F.3d 1359, 1365 (Fed. Cir. 2015)).
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`EX1041, ¶¶264-362 discuss the application of the prior art to the claims of
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`the ‘876 patent, which is not used as a ground in this proceeding, but which
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`provides context regarding how a POSA would have considered and applied
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`Meezan (EX1011), a primary references, in view of a POSA’s knowledge of Sonne
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`(EX1013), which is not a reference used in any ground in this proceeding.
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`D. EX1050.
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`EX1050 (diazepam solutions described in or based on Example 11, Sonne,
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`EX1013) should not be excluded. Dr. Peppas testified how he arrived at EX1050
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`based on Sonne (EX1013), the motivation a POSA would have had to do so, and
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`reported the results. See PeppasDec. EX1041, ¶¶ 183, 185, 189, 264, 269, 341; see
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`also response II.C. above.
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`E. EX1069.
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`EX1069 (“Florida Regional Common EMS Protocols Field Guide”) is
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`relevant and not confusing, wasteful, or prejudicial, it is not hearsay and not
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`hearsay without exception (where it is used for the truth), and is self-authenticating
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`(to the extent it needs to be). EX1069 “document[s] the knowledge that skilled
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`artisans would bring to bear in reading the prior art identified as producing
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`obviousness.” Genzyme Therapeutic, 825 F.3d at 1369 (quoting Ariosa
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`Diagnostics, 805 F.3dat 1365 (which also stated “Exhibit 1010 had to be
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`considered by the Board even though it was not one of the three pieces of prior art
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`presented as the basis for obviousness.”)).
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`EX1069 is used to rebut Dr. Gizurarson’s assertion that the ‘876 patent was
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`not obvious because others had purportedly failed to formulate diazepam
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`intravenous solutions for intranasal administration to address seizures (see, e.g.,
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`GizurarsonDec. EX2012, ¶36). Responding to a question whether he was “aware
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`of any intranasal formulations containing diazepam that have been used?”, Dr.
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`Gizurarson testified, “I am not aware of that.” GizurarsonDep. EX1149, 23:22-24.
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`Exhibit 1069 is directly relevant and rebuts PO’s argument that “[o]bjective
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`evidence of the failure of others to formulate a diazepam intranasal spray and a
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`long-felt but unmet need to do so further supports a finding of non-obviousness.
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`EX2012, ¶¶36, 116.” POR, p. 40.
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`EX1069 is also relevant, inter alia, as it rebuts the following arguments by
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`PO:
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`• PO’s long felt need arguments. POR 1, 2, 40-44, Gizurarson Dec. Ex. 2012,
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`¶¶ 51, 78, 110-116. “If prior art products [EX1069] were effective for the
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`purpose of the claimed invention, there is no long-felt need.” AstraZeneca
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`LP v. Breath Ltd., 88 F. Supp. 3d 326, 387 (D.N.J. 2015).
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`• PO’s arguments regarding motivation to combine and mixing alcohols. POR
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`23-44; Gizurarson Dec. Ex. 2012, ¶¶ 76-117. It also elaborates on
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`arguments made in Petition and advanced by Dr. Peppas. See, e.g., Petition
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`33-35; Peppas Dec. Ex. 1041, ¶¶ 257-262.
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`• PO’s solubility arguments (POR 29; Gizurarson Dec. Ex. 2012, ¶¶ 82-83)
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`with solubility effect of three solvents (Reply 14; Wermeling Dec. Ex.1150,
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`¶¶ 129-145).
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`EX1069 is a true and correct copy of the original. In response to Patent
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`Owner’s Objections dated February 4, 2020 (Paper 23) regarding, inter alia,
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`EX1069, Petitioner served on February 19, 2020 the Declaration of Michael I.
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`Chakansky, pursuant to 37 C.F.R. § 42.64(b)(2) (“ChakanskyDec. Ex1152”), now
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`being filed in support of Petitioner’s Opposition to PO’s Motion to Exclude,
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`which expressly states at paragraph 3: “Exhibit 1069 is a true and correct copy of
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`the Florida Regional Common EMS Protocols Field Guide, Jones and Barlett
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`Publishers, MA (2005). If Patent Owner desires, Aquestive will make the
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`original pamphlet available for inspection and copying at our offices.”
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`(emphasis in original). During the deposition of Dr. Wermeling on February 26,
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`2020, PO’s counsel was offered the opportunity to inspect the original but did not
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`avail herself of that opportunity. Having had the opportunity to inspect the
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`original, PO should not be heard now to complain.
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`Florida EMS Protocol, EX1069, p. 0003, states that the copyright for the
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`Field Guide is co-owned by the publisher and the Fire Chiefs Association of
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`Broward County, Inc. (“Fire Chiefs”). The Fire Chiefs “proudly represent 31
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`individual municipalities with a combined population of 1.91 million people”. See
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`https://fcabc.com/about-us/. The Fire Chiefs represent many individual
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`government municipalities and this exhibit is an official publication available to
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`U.S. Patent No. 9,763,876
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`the public. See FRE 803(8) (hearsay exception) and 902 (self-authentication).
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`Statements relied on in EX1069 are supported by sufficient guarantees of
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`trustworthiness and are probative regarding the administration of formulations of
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`benzodiazepines intranasally and thus are admissible under FRE 807, the residual
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`exception to hearsay.
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`F. EX1080.
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`EX1080 (Valium® label) is a true and correct copy of the Valium® Tablet
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`Label, Roche, January 2008, obtained from the FDA website on the Internet at the
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`following url: https://www.accessdata. fda.gov/drugsatfda_docs/
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`label/2008/013263s083lbl.pdf. See ChakanskyDec. EX1152, ¶9. The FDA label is
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`a self-authenticating public record available on the FDA’s website , which
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`sufficiently guarantees the trustworthiness of its disclosure and is probative
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`regarding the composition and characteristics of Valium® (diazepam). See FRE
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`803(8) (hearsay exception), 902 (self-authentication) and FRE 807 (residual
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`exception to hearsay).
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`G. EX1081.
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`EX1081 (webpage showing “Diazepam Prices and Coupons”) is a true and
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`correct copy of the pages showing Drug Prices from Internet for: Diazepam (form
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`- syringe, dosage - 2ml of 5mg/ml) found at https://www.webmd.com/rx/drug-
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`prices/diazepam; Diastat Acudial (form- gel, dosage 10mg) found at
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`https://www.webmd.com/rx/drug-prices/diazepam; and “How much should I
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`expect to pay for Nayzilam® (midazolam) nasal spray, CIV?” found at https://ucb-
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`usa.com/Responsibility/Affordability/Nayzilam-Pricing-Info. See ChakanskyDec.
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`EX1152, ¶10. It is used to demonstrate the type of information the public has
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`available over the Internet regarding the relative cost of drugs. It is not used to
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`prove the actual cost of the drugs.
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`H. EX1122
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`EX1122, “A Multiple-Dose Phase I Study of Intranasal Hydromorphone
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`Hydrochloride in Healthy Volunteers” is used by Dr. Wermeling (EX1150, ¶68) to
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`demonstrate the knowledge a POSA would have considered in the product design
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`of an intranasal delivery product and as such it “document[s] the knowledge that
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`skilled artisans would bring to bear in reading the prior art identified as producing
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`obviousness.” Genzyme Therapeutic, 825 F.3dat 1369 (quoting Ariosa Diagnostic,
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`805 F.3dat 1365 (which also stated “Exhibit 1010 had to be considered by the
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`Board even though it was not one of the three pieces of prior art presented as the
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`basis for obviousness.”)). Exhibit 1122 is relevant to the state of the art and not
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`confusing, wasteful, or prejudicial and should not be excluded.
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`I. EX1150.
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`1. EX1150 should not be excluded in its entirety.
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`EX1150, the declaration of Dr. Wermeling, is relevant and is not confusing,
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`wasteful, or prejudicial and should not be excluded Under FRE 402 and/or 403.
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`Dr. Wermeling’s Declaration responds to and rebut arguments PO made in
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`its responses, including the PPOR, POR and statements by PO’s expert, and
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`addresses issues raised in the Institution Decision. See Belden Inc. v. Berk-Tek
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`LLC, 805 F.3d 1064, 1077–78, 1081 (Fed. Cir. 2015), and Patent Trial and Appeal
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`Board Consolidated Trial Practice Guide (November 2019), p. 73. Its reliance on
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`prior art is proper as such “document[s] the knowledge that skilled artisans would
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`bring to bear in reading the prior art identified as producing obviousness.”
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`Genzyme Therapeutic, 825 F.3dat 1369 (quoting Ariosa Diagnostics, 805 F.3d at
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`1365 (which also stated “Exhibit 1010 had to be considered by the Board even
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`though it was not one of the three pieces of prior art presented as the basis for
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`obviousness.”)).
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`“As we have regularly held, ‘the petitioner in an inter partes review
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`proceeding may introduce new evidence after the petition stage if the evidence is a
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`legitimate reply to evidence introduced by the patent owner.’ Anacor Pharms., Inc.
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`v. Iancu, 889 F.3d 1372, 1380-81 (Fed. Cir. 2018).” Apple Inc. v. Andrea Elecs.
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`Corp., 949 F.3d 697, 706-07 (Fed. Cir. 2020); see also Chamberlain Grp., Inc. v.
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`One World Techs., Inc., 944 F.3d 919, 925 (Fed. Cir. 2019) (“Parties are not barred
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`from elaborating on their arguments on issues previously raised.”).
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`PO had ample opportunity to address Petitioner’s arguments responding to
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`PO’s Response and the Institution Decision. In addition to the deposition of Dr.
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`Wermeling, PO requested and was granted an additional 1000 words for its sur-
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`reply (see EX2027, p. 24). Nevertheless, PO used only 5358 words, far less than
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`the 6600 it was permitted to address any of its alleged concerns regarding
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`Petitioner’s arguments. See Surreply, Paper 28.
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`See also argument below at II.I.2.
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`2. EX1150, paragraphs 23-30, 59-89, 90-126, 146, 171-177,
`191-194, and 208 should not be excluded.
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`Paragraphs 23-30, 59-89, 90-126, 146, 171-177, 191-194, and 208 of
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`EX1150 the declaration of Dr. Wermeling should not be excluded under FRE 402-
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`403, 602, 701-702, 805 or 1006. In general, see discussion above at II.I.1 and
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`additional argument below.
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`As to FRE 402 and 403 the objected to paragraphs are relevant and not
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`confusing, wasteful, or prejudicial and should not be excluded for the reasons
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`given above at II.I.1 and additional arguments below.
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`Regarding PO’s FRE 602, 701 and 702 objections, Dr. Wermeling has
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`academic experience and practical expertise in intravenous and intranasal drug
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`delivery and in the economics of drug deliver development and marketing. See
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`WermelingDec. EX1150, ¶¶31-40 and Appendix A (his CV). He also testified at
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`his deposition to that expertise (WermelingDep. EX2031), for example: 8:3-11:3
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`(he is an expert in IV and IN formulations for drug delivery, he has written on the
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`economics of anesthesia-related medications and in the operating theater,
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`significant experience, is an expert in FDA practice and procedure, with significant
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`experience in regulatory affairs); 76:22-83:16 (familiar with how pharmaceutical
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`and generic companies price their products); 85:9-87:2 (he is very familiar with
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`505(b)(2) pathway, sometimes his sole job was to handle regulatory affairs, when
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`he wasn't in a company and would do it as a professor, not as a company).
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`EX1150, ¶¶ 23-30 rebuts PO’s new “ordinary meaning” claim construction.
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`POR, 12-13. Petitioner maintained claim limitations should be given their ordinary
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`and customary meaning. Petition, Paper 3, p. 9. One of those limitations for
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`which a specific claim construction was not given was “ethanol.” Using its
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`proposed construction, PO argued the challenged claims exclude water and a
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`POSA would not be motivated to use Meezan’s alkyl glycosides. POR, 38, see
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`also 25. Because of PO’s strained proposed construction, Petitioner needed to
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`respond and further explain in its Reply, as supported by Dr. Wermeling, that the
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`ordinary meaning of ethanol included water. WermelingDec. EX1150 ¶¶ 23-30.
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`The ‘876 patent claims recite “ethanol” and “dehydrated ethanol” and the plain and
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`ordinary meaning of “ethanol” is “ethanol USP” which requires the presence of
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`water. The USP definition and the ‘876 patent specification are the underlying
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`facts to this conclusion. Wermeling Dec. Ex. 1150, ¶¶ 23-30. Therefore, in
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`addition to the above, these paragraphs should not be excluded under FRE 701,
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`702.
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`EX1150, ¶¶59-89, 90-126 rebuts PO’s “secondary considerations”
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`arguments, including alleged problems obtaining solutions for administering
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`benzodiazepines intranasally. See, e.g., POR 1,2, 6-8, 40-44; Gizurarson Ex.
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`2012, ¶¶ 47-60, 110-113, 116. In particular, EX1150, ¶¶110-126 rebuts PO’s long
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`felt need arguments and assertions that problems in formulating an intranasal
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`formulation was the reason for the delay in obtaining an FDA approved product to
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`market. POR 1, 2, 40, 44; Gizurarson Dec. Ex. 2012, ¶ 78, 110-113. These are
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`topics are well within Dr. Wermeling’s area of expertise and experience. See, e.g.,
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`WermelingDec. EX1150, ¶¶31-40 and Appendix A (his CV), WermelingDep.
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`EX2031, 8:3-11:3, 76:22-83:16, 85:9-87:2 and above.
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`EX1150 ¶¶ 171-177 rebuts PO’s position (POR 10-12, 22-23) and supports
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`Petition and Dr. Peppas statements that alkyl glycosides are not disclosed,
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`described, or enabled by ‘558 Provisional. Petition 19-20; Peppas Dec. Ex. 1041,
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`¶68; Wermeling Dec. Ex. 1150, ¶¶ 171-177.
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`EX1150, ¶¶ 191-194 is not hearsay within hearsay under FRE 805. First Dr.
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`Wermeling is not suggesting that EX1025 provides the correct bioavailability.
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`Instead, he is merely opining that a POSA when closely considering EX1025,
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`based on information provided in EX1025, would not consider the bioavailability
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`information disclosed in EX1025 as being supported by EX1025. It is not hearsay
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`within hearsay.
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`EX1150, ¶¶ 102-102 are predicated on Dr. Wermeling’s real world
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`experience and academic training, , that a POSA would design a matrix of
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`excipients as possible formulation candidates.
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`J. EX1149 portions.
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`The line of questioning during Dr. Gizurarson’s cross-examination
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`(GizurarsonDep. EX1149) on (i) pages 0024-0027 discussing EX1069 and on (ii)
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`pages 0086-0088 discussing EX1065 should not be excluded.
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`(i)
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`First, pages 0024-0027 should not be excluded. The cross-examination was
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`proper and within the permitted scope. EX1069 was put aside at the end of page
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`0026, not 0027. See EX1149, 26:24-25. EX1069 was used to confront Dr.
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`Gizurarson’s assertion that the ‘876 patent was non-obviousness because others
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`had purportedly failed to formulate diazepam intravenous solutions for intranasal
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`administration to address seizures (see, e.g., GizurarsonDec. EX2012, ¶36) and
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`was introduced after the following question and answer: Q Are you aware of any
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`intranasal formulations containing diazepam that have been used? A I am not
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`aware of that. GizurarsonDep. EX1149, 23:22-24. This is relevant as PO relied
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`on these statements as support of its non-obviousness argument: “Objective
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`evidence of the failure of others to formulate a diazepam intranasal spray and a
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`long-felt but unmet need to do so further supports a finding of non-obviousness.
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`EX2012, ¶¶36, 116.” POR, p. 40. Certainly, Petitioner’s questions were within
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`the scope of the cross-examination of Dr. Gizurarson. There was no confusion as
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`to Dr. Gizurarson’s lack of knowledge regarding the practice of using in the field a
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`diazepam intravenous formulation for intranasal administration to treat seizures as
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`demonstrated by EX1069.
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`(ii) Second, pages 0086-0088 should not be excluded. The cross-examination
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`was proper and within the permitted scope. EX1065, is a provisional application,
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`incorporated by reference into Meezan (EX1011), one of Petitioner’s primary
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`references, and Petitioner’s counsel was attempting to address the scope of
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`Meezan’s disclosure of alkyl glycosides in non-aqueous solutions. GizararsonDep.
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`EX1149, 82:17-21 (“Q Okay. So does Meezan disclose the use of surfactants,
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`including alkyl glycoside, in a non-aqueous setting as well as an aqueous setting?
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`MS. MORGAN: Objection. Form. THE WITNESS: I would not say so . . .”). PO
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`has argued that Meezan’s disclosure would have motivated a POSA to limit the use
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`of alkyl glycosides to aqueous solutions. See, e.g., POR, p. 23. Petitioner’s cross
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`examination was proper.
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`K. Limiting Request Under FRE 105
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`None of Petitioner’s exhibits should be limited.
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`III. CONCLUSION
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`For the foregoing reasons, Patent Owner’s Motion to Exclude (Paper 35)
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`should be denied.
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`Dated: April 28, 2019.
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`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
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`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
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`First Backup Counsel for
`Petitioner Aquestive Therapeutics, Inc.
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`14
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this the 28th day of April 2020, the foregoing
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
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`EXCLUDE EVIDENCE was served in its entirety on the following counsel of
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`record by electronic service by email at the email addresses as set forth below.
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` Jeffrey Guise
`Richard Torczon
`Lorelei Westin
`Lee Johnson
`Nathaniel Leachman
`Alina L. Litoshyk
`Wendy Devine
`WILSON SONSINI GOODRICH & ROSATI
`jguise@wsgr.com
`rtorczon@wsgr.com
`lwestin@wsgr.com
`ljohnson@wsgr.com
`nleachman@wsgr.com
`alitoshyk@wsgr.com
`wdevine@wsgr.com
`35401.652.palib1@matters.wsgr.com
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`By:
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`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
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`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
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`15
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