UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`NEURELIS, INC.,
`Patent Owner.
`____________________
`
`Case IPR2019-00451
`Patent 9,763,876
`____________________
`
`NEURELIS, INC. OBJECTIONS
`37 C.F.R. §42.64(b)(1)
`
`

`

`TABLE OF CONTENTS
`
`Pages
`
`I. Objections ............................................................................................................. 1
`
`EX1009: Cartt et al., WO 2009/121039 ........................................................... 1
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 1
`
`FRE 802 (hearsay without exception) ............................................................. 1
`
`FRE 105 (limited purpose) .............................................................................. 1
`
`EX1010: Cartt, US 2009/0258865 ................................................................... 1
`
`FRE 802 (hearsay without exception) ............................................................. 1
`
`FRE 105 (limited purpose) .............................................................................. 1
`
`EX1011: Meezan et al., US 2006/0046962 ...................................................... 2
`
`FRE 802 (hearsay without exception) ............................................................. 2
`
`FRE 105 (limited purpose) .............................................................................. 2
`
`EX1012:
`
`Jamieson et al., US 2008/0070904 ................................................... 2
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 2
`
`FRE 802 (hearsay without exception) ............................................................. 2
`
`FRE 105 (limited purpose) .............................................................................. 2
`
`EX1013: Sonne, US 6,193,985 ........................................................................ 2
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`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 2
`
`FRE 802 (hearsay without exception) ............................................................. 3
`
`FRE 105 (limited purpose) .............................................................................. 3
`
`EX1014: Gwozdz et al., WO 2009/120933...................................................... 3
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 3
`
`FRE 802 (hearsay without exception) ............................................................. 3
`
`FRE 105 (limited purpose) .............................................................................. 3
`
`EX1015: Cartt et al., US 2008/279784 ............................................................ 4
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 4
`
`FRE 802 (hearsay without exception) ............................................................. 4
`
`FRE 105 (limited purpose) .............................................................................. 4
`
`EX1016: Kee et al., US 5,369,095 ................................................................... 4
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 4
`
`FRE 802 (hearsay without exception) ............................................................. 4
`
`FRE 105 (limited purpose) .............................................................................. 5
`
`EX1017: Cartt et al., WO 2008/137960 ........................................................... 5
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 5
`
`FRE 802 (hearsay without exception) ............................................................. 5
`
`FRE 105 (limited purpose) .............................................................................. 5
`
`EX1018: Tenta, US 3,949,072 ......................................................................... 5
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`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 5
`
`FRE 802 (hearsay without exception) ............................................................. 6
`
`FRE 105 (limited purpose) .............................................................................. 6
`
`EX1019: Ueda et al., US 4,657,901 ................................................................. 6
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 6
`
`FRE 802 (hearsay without exception) ............................................................. 6
`
`FRE 105 (limited purpose) .............................................................................. 6
`
`EX1020: Meezan et al., US 5,661,130 ............................................................. 6
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 6
`
`FRE 802 (hearsay without exception) ............................................................. 7
`
`FRE 105 (limited purpose) .............................................................................. 7
`
`EX1021: Merkus, US 2005/0153956 ............................................................... 7
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 7
`
`FRE 802 (hearsay without exception) ............................................................. 7
`
`FRE 105 (limited purpose) .............................................................................. 7
`
`EX1022: Liversidge et al., US 2006/0198896 ................................................. 8
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 8
`
`FRE 802 (hearsay without exception) ............................................................. 8
`
`FRE 105 (limited purpose) .............................................................................. 8
`
`EX1023: EX1026 – Ritschel Handbook .......................................................... 8
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`FRE 802 (hearsay without exception) ............................................................. 8
`
`FRE 901 (authentication) ................................................................................. 8
`
`FRE 105 (limited purpose) .............................................................................. 8
`
`EX1024: Osborne et al. Article ........................................................................ 9
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 9
`
`FRE 802 (hearsay without exception) ............................................................. 9
`
`FRE 901 (authentication) ................................................................................. 9
`
`FRE 105 (limited purpose) .............................................................................. 9
`
`EX1025: Lindhardt et al. Article ...................................................................... 9
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 9
`
`FRE 802 (hearsay without exception) ........................................................... 10
`
`FRE 105 (limited purpose) ............................................................................ 10
`
`EX1026: Kibbe et al. Handbook .................................................................... 10
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 10
`
`FRE 802 (hearsay without exception) ........................................................... 10
`
`FRE 901 (authentication) ............................................................................... 10
`
`FRE 105 (limited purpose) ............................................................................ 10
`
`EX1027:
`
`Illum Article .................................................................................... 11
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`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 11
`
`FRE 802 (hearsay without exception) ........................................................... 11
`
`FRE 105 (limited purpose) ............................................................................ 11
`
`EX1028:
`
`Ivaturi et al. Article ......................................................................... 11
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 11
`
`FRE 802 (hearsay without exception) ........................................................... 11
`
`FRE 105 (limited purpose) ............................................................................ 12
`
`EX1029: O’Dell et al. Article......................................................................... 12
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 12
`
`FRE 802 (hearsay without exception) ........................................................... 12
`
`FRE 105 (limited purpose) ............................................................................ 12
`
`EX1030: Gizurarson et al. Article .................................................................. 12
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 12
`
`FRE 802 (hearsay without exception) ........................................................... 13
`
`FRE 105 (limited purpose) ............................................................................ 13
`
`EX1031: Rowe et al. Handbook ..................................................................... 13
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 13
`
`FRE 802 (hearsay without exception) ........................................................... 13
`
`FRE 901 (authentication) ............................................................................... 13
`
`FRE 105 (limited purpose) ............................................................................ 13
`
`EX1032: Edman [II] et al. Article .................................................................. 14
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`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 14
`
`FRE 802 (hearsay without exception) ........................................................... 14
`
`FRE 105 (limited purpose) ............................................................................ 14
`
`EX1033: French Article ................................................................................. 14
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 14
`
`FRE 802 (hearsay without exception) ........................................................... 14
`
`FRE 105 (limited purpose) ............................................................................ 15
`
`EX1034: Edman [I] et al. Article ................................................................... 15
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 15
`
`FRE 802 (hearsay without exception) ........................................................... 15
`
`FRE 105 (limited purpose) ............................................................................ 15
`
`EX1035: Davis Article ................................................................................... 15
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 15
`
`FRE 802 (hearsay without exception) ........................................................... 16
`
`FRE 105 (limited purpose) ............................................................................ 16
`
`EX1036: Deshmukh et al. Article .................................................................. 16
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 16
`
`FRE 802 (hearsay without exception) ........................................................... 16
`
`FRE 105 (limited purpose) ............................................................................ 16
`
`EX1037: Colombo Entry ................................................................................ 16
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`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 16
`
`FRE 802 (hearsay without exception) ........................................................... 17
`
`FRE 901 (authentication) ............................................................................... 17
`
`FRE 105 (limited purpose) ............................................................................ 17
`
`EX1038: Bara, US 2006/0178290 .................................................................. 17
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 17
`
`FRE 802 (hearsay without exception) ........................................................... 17
`
`FRE 105 (limited purpose) ............................................................................ 17
`
`EX1039: Behl et al. Article ............................................................................ 18
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 18
`
`FRE 802 (hearsay without exception) ........................................................... 18
`
`FRE 105 (limited purpose) ............................................................................ 18
`
`EX1040: EP File History ................................................................................ 18
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 18
`
`FRE 802 (hearsay without exception) ........................................................... 18
`
`FRE 901 (authentication) ............................................................................... 19
`
`FRE 105 (limited purpose) ............................................................................ 19
`
`EX1041: Peppas Declaration.......................................................................... 19
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`FRE 402 (relevance) ...................................................................................... 19
`
`FRE 403 (prejudice, confusion, waste) ......................................................... 19
`
`FRE 602 (personal knowledge) ..................................................................... 19
`
`FRE 701 (improper lay testimony); 702 (unqualifed expert testimony) ....... 19
`
`FRE 802 (hearsay without exception) ........................................................... 20
`
`FRE 805 (hearsay within hearsay)................................................................. 20
`
`FRE 1006 (summary to prove content) ......................................................... 20
`
`FRE 105 (limited purpose) ............................................................................ 20
`
`EX1042: PDR ................................................................................................. 21
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 21
`
`FRE 802 (hearsay without exception) ........................................................... 21
`
`FRE 901 (authentication) ............................................................................... 21
`
`FRE 105 (limited purpose) ............................................................................ 21
`
`EX1043: Knoester et al. Article ..................................................................... 21
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 21
`
`FRE 802 (hearsay without exception) ........................................................... 22
`
`FRE 105 (limited purpose) ............................................................................ 22
`
`EX1044: USP NF 2003 .................................................................................. 22
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`FRE 802 (hearsay without exception) ........................................................... 22
`
`FRE 901 (authentication) ............................................................................... 22
`
`FRE 105 (limited purpose) ............................................................................ 22
`
`EX1045: Maitani et al. Article ....................................................................... 22
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 22
`
`FRE 802 (hearsay without exception) ........................................................... 23
`
`FRE 105 (limited purpose) ............................................................................ 23
`
`EX1046: Gwozdz ’281 ................................................................................... 23
`
`FRE 802 (hearsay without exception) ........................................................... 23
`
`FRE 105 (limited purpose) ............................................................................ 23
`
`EX1048: Kagatani et al., US 4,690,952 ......................................................... 23
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 23
`
`FRE 802 (hearsay without exception) ........................................................... 23
`
`FRE 105 (limited purpose) ............................................................................ 24
`
`EX1050: DS11................................................................................................ 24
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 24
`
`FRE 802 (hearsay without exception) ........................................................... 24
`
`FRE 1006 (summary to prove content) ......................................................... 24
`
`FRE 105 (limited purpose) ............................................................................ 24
`
`II. Conclusion ..........................................................................................................24
`
`Certificate of Service ...............................................................................................26
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`The patent owner (“Neurelis”) submits the following objections to pre-
`
`institution evidence of the petitioner (“Aquestive”).
`
`I.
`
`OBJECTIONS
`EX1009: CARTT ET AL., WO 2009/121039
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1010: CARTT, US 2009/0258865
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
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`EX1011: MEEZAN ET AL., US 2006/0046962
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`JAMIESON ET AL., US 2008/0070904
`EX1012:
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`SONNE, US 6,193,985
`EX1013:
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
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`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1014: GWOZDZ ET AL., WO 2009/120933
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not prior art and is not relevant to any instituted ground. The
`
`exhibit’s probative value is substantially outweighed by its confusion of the issues
`
`to be decided, its waste of Board and Neurelis time, and the danger that it will lead
`
`to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
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`EX1015: CARTT ET AL., US 2008/279784
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not prior art and is not relevant to any instituted ground. The
`
`exhibit’s probative value is substantially outweighed by its confusion of the issues
`
`to be decided, its waste of Board and Neurelis time, and the danger that it will lead
`
`to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1016: KEE ET AL., US 5,369,095
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
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`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1017: CARTT ET AL., WO 2008/137960
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`TENTA, US 3,949,072
`EX1018:
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
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`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1019: UEDA ET AL., US 4,657,901
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1020: MEEZAN ET AL., US 5,661,130
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
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`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1021: MERKUS, US 2005/0153956
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
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`LIVERSIDGE ET AL., US 2006/0198896
`EX1022:
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1026 – RITSCHEL HANDBOOK
`EX1023:
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 901 (authentication)
`Aquestive failed to provide evidence sufficient to establish the exhibit is
`
`what it is purported to be.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
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`EX1024: OSBORNE ET AL. ARTICLE
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 901 (authentication)
`The exhibit includes pages 006-035 of unknown provenance, without
`
`explanation of their source. Aquestive failed to provide evidence sufficient to
`
`establish the exhibit is what it is purported to be.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`LINDHARDT ET AL. ARTICLE
`EX1025:
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
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`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1026: KIBBE ET AL. HANDBOOK
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 901 (authentication)
`Aquestive failed to provide evidence sufficient to establish the exhibit is
`
`what it is purported to be.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`-10-
`
`IPR2019-0045
`
`

`

`ILLUM ARTICLE
`EX1027:
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`IVATURI ET AL. ARTICLE
`EX1028:
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`-11-
`
`IPR2019-0045
`
`

`

`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX1029: O’DELL ET AL. ARTICLE
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petition and is not relevant to any instituted
`
`ground. The exhibit’s probative value is substantially outweighed by its confusion
`
`of the issues to be decided, its waste of Board and Neurelis time, and the danger
`
`that it will lead to unfair prejudice if used later in the proceeding or on appeal.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the petition.
`
`EX103