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 
`
`EX1065:  Maggio, Provisional Application No. 60/632,038 ............................ 1 
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 1 
`
`FRE 802 (hearsay without exception) ............................................................. 1 
`
`EX1069:  Florida Regional Common EMS Protocols Field Guide
`(2005)
` ........................................................................................................... 1 
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 1 
`
`FRE 802 (hearsay without exception) ............................................................. 1 
`
`FRE 901 (authentication) ................................................................................. 2 
`
`FRE 105 (limited purpose) .............................................................................. 2 
`
`EX1070:  Gizurarson, U.S. Patent Application No. 2008/0275030
`(2008)
` ........................................................................................................... 2 
`
`FRE 105 (limited purpose) .............................................................................. 2 
`
`EX1072:  Nayzilam Product Label ................................................................... 2 
`
`FRE 802 (hearsay without exception) ............................................................. 2 
`
`FRE 901 (authentication) ................................................................................. 2 
`
`FRE 105 (limited purpose) .............................................................................. 2 
`
`EX1074:  Goodman & Gilman’s, The Pharmaceutical Basis of
`Therapeutics (2001) ........................................................................................ 3 
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`FRE 802 (hearsay without exception) ............................................................. 3 
`
`FRE 901 (authentication) ................................................................................. 3 
`
`FRE 105 (limited purpose) .............................................................................. 3 
`
`EX1076:  The Merck Index (1996) ................................................................... 3 
`
`FRE 802 (hearsay without exception) ............................................................. 3 
`
`FRE 901 (authentication) ................................................................................. 3 
`
`FRE 105 (limited purpose) .............................................................................. 3 
`
`EX1077:  Ritchel WA, et al., Handbook of Basic Pharmacokinetics
`(2004)
` ........................................................................................................... 4 
`
`FRE 802 (hearsay without exception) ............................................................. 4 
`
`FRE 901 (authentication) ................................................................................. 4 
`
`FRE 105 (limited purpose) .............................................................................. 4 
`
`EX1078:  USP/NF 2003, Ethanol (2002) .......................................................... 4 
`
`FRE 802 (hearsay without exception) ............................................................. 4 
`
`FRE 901 (authentication) ................................................................................. 4 
`
`FRE 105 (limited purpose) .............................................................................. 4 
`
`EX1080:  Valium® Tablet Label (2008) .......................................................... 5 
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`FRE 802 (hearsay without exception) ............................................................. 5 
`
`FRE 901 (authentication) ................................................................................. 5 
`
`FRE 105 (limited purpose) .............................................................................. 5 
`
`EX1081:  Drug Prices ........................................................................................ 5 
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................ 5 
`
`FRE 802 (hearsay without exception) ............................................................. 5 
`
`FRE 901 (authentication) ................................................................................. 6 
`
`FRE 105 (limited purpose) .............................................................................. 6 
`
`EX1082:  Chien YW, et al., Nasal Systemic Drug Delivery (1989) ................. 6 
`
`FRE 802 (hearsay without exception) ............................................................. 6 
`
`FRE 901 (authentication) ................................................................................. 6 
`
`FRE 105 (limited purpose) .............................................................................. 6 
`
`EX1101:  Lowenstein DH, et al., Status Epilipticus (1998) ............................. 6 
`
`FRE 802 (hearsay without exception) ............................................................. 6 
`
`FRE 105 (limited purpose) .............................................................................. 7 
`
`EX1102:  Lowenstein DH, et al., It’s Time to Revise the Definition of
`Status Epilepticus (1999) ................................................................................ 7 
`
`FRE 802 (hearsay without exception) ............................................................. 7 
`
`FRE 105 (limited purpose) .............................................................................. 7 
`
`EX1103:  Wang HC, et al. Factors Predictive of Outcome in
`Posttraumatic Seizures (2008) ........................................................................ 7 
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`FRE 802 (hearsay without exception) ............................................................. 7 
`
`FRE 105 (limited purpose) .............................................................................. 7 
`
`EX1104:  Stavem K, et al., Long-Term Seizures and Quality of Life
`After Epilepsy Surgery (2008) ....................................................................... 7 
`
`FRE 802 (hearsay without exception) ............................................................. 7 
`
`FRE 105 (limited purpose) .............................................................................. 8 
`
`EX1105:  Logroscino G, et al., Time Trends in Incidence, Mortality,
`and Case-Fatality After First Episode of Status Epilepticus (2001) .............. 8 
`
`FRE 802 (hearsay without exception) ............................................................. 8 
`
`FRE 105 (limited purpose) .............................................................................. 8 
`
`EX1106:  Feen ES, et al., Status Epilepticus (2008) ......................................... 8 
`
`FRE 802 (hearsay without exception) ............................................................. 8 
`
`FRE 105 (limited purpose) .............................................................................. 8 
`
`EX1107:  Pang T, et al., Treatment of Convulsive and Nonconvulsive
`Status Epilepticus (2005) ................................................................................ 9 
`
`FRE 802 (hearsay without exception) ............................................................. 9 
`
`FRE 105 (limited purpose) .............................................................................. 9 
`
`EX1108:  Smith B, Treatment of Status Epilepticus (2001) ............................. 9 
`
`FRE 802 (hearsay without exception) ............................................................. 9 
`
`FRE 105 (limited purpose) .............................................................................. 9 
`
`EX1109:  Ericksson K, Pharmacologic Management of Convulsive
`Status Epilepticus in Childhood (2005) .......................................................... 9 
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`FRE 802 (hearsay without exception) ............................................................. 9 
`
`FRE 105 (limited purpose) .............................................................................. 9 
`
`EX1110:  Wolfe T, et al., Intranasal Midazolam Therapy for Pediatric
`Status Epilepticus (2006) .............................................................................. 10 
`
`FRE 802 (hearsay without exception) ........................................................... 10 
`
`FRE 105 (limited purpose) ............................................................................ 10 
`
`EX1111:  Meierkord H, et al., EFNS Guideline on the Management of
`Status Epilepticus (2006) .............................................................................. 10 
`
`FRE 802 (hearsay without exception) ........................................................... 10 
`
`FRE 105 (limited purpose) ............................................................................ 10 
`
`EX1112:  Prasad K, et al., Anticonvulsant Therapy for Status
`Epilepticus (2007) ......................................................................................... 10 
`
`FRE 802 (hearsay without exception) ........................................................... 10 
`
`FRE 105 (limited purpose) ............................................................................ 11 
`
`EX1113: 
`
`Illum L, Nasal Clearance in Health and Diabetes (2006) ............... 11 
`
`FRE 802 (hearsay without exception) ........................................................... 11 
`
`FRE 105 (limited purpose) ............................................................................ 11 
`
`EX1114:  Merkus P, Influence of Anatomy and Head Position on
`Intranasal Drug Deposition (2006) ............................................................... 11 
`
`FRE 802 (hearsay without exception) ........................................................... 11 
`
`FRE 105 (limited purpose) ............................................................................ 11 
`
`EX1115: 
`
`Illum L, Transport of Drugs From the Nasal Cavity to the
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`Central Nervous System (2000) ................................................................... 11 
`
`FRE 802 (hearsay without exception) ........................................................... 11 
`
`FRE 105 (limited purpose) ............................................................................ 12 
`
`Illum L, Is Nose to Brain Transport of Drugs in Man a
`EX1116: 
`Reality (2004) ............................................................................................... 12 
`
`FRE 802 (hearsay without exception) ........................................................... 12 
`
`FRE 105 (limited purpose) ............................................................................ 12 
`
`EX1117:  Merkus F, et al., Can Nasal Drug Delivery Bypass the Blood-
`Brain Barrier (2007) ..................................................................................... 12 
`
`FRE 802 (hearsay without exception) ........................................................... 12 
`
`FRE 105 (limited purpose) ............................................................................ 12 
`
`EX1118:  Constantino, et al. Intranasal Delivery: Physicochemical and
`Therapeutic Aspects (2007) .......................................................................... 13 
`
`FRE 802 (hearsay without exception) ........................................................... 13 
`
`FRE 901 (authentication) ............................................................................... 13 
`
`FRE 105 (limited purpose) ............................................................................ 13 
`
`EX1119:  Davis GA, et al., Effect of Fluticasone Propionate Nasal
`Spray (2004) ................................................................................................. 13 
`
`FRE 802 (hearsay without exception) ........................................................... 13 
`
`FRE 105 (limited purpose) ............................................................................ 13 
`
`EX1120:  Davis GA, et al., Bioavailability and Pharmacokinetics of
`Intranasal Hydromorphone (2004) ............................................................... 13 
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`FRE 802 (hearsay without exception) ........................................................... 13 
`
`FRE 105 (limited purpose) ............................................................................ 14 
`
`EX1121:  Holsti M, et al., Prehospital Intranasal Midazolam for the
`Treatment of Pediatric Seizures (2007) ........................................................ 14 
`
`FRE 802 (hearsay without exception) ........................................................... 14 
`
`FRE 105 (limited purpose) ............................................................................ 14 
`
`EX1122:  Rudy AC, et al., A Multiple Dose Phase 1 Study of Intranasal
`Hydromorphone Hydrochloride (2004) ........................................................ 14 
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ...................... 14 
`
`FRE 802 (hearsay without exception) ........................................................... 14 
`
`FRE 105 (limited purpose) ............................................................................ 14 
`
`EX1125:  Loftsson T, et al., Cyclodextrin Solubilization of
`Benzodiazepines (2001) ............................................................................... 15 
`
`FRE 802 (hearsay without exception) ........................................................... 15 
`
`FRE 105 (limited purpose) ............................................................................ 15 
`
`EX1127:  Gudmundsdottir H, et al., Intranasal Administration of
`Midazolam in Cyclodextrin Based Formulation (2001) ............................... 15 
`
`FRE 802 (hearsay without exception) ........................................................... 15 
`
`FRE 105 (limited purpose) ............................................................................ 15 
`
`EX1128:  Dale O, et al., Intranasal Midazolam Comparison Study
`(2006)
` ......................................................................................................... 15 
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`FRE 802 (hearsay without exception) ........................................................... 15 
`
`FRE 105 (limited purpose) ............................................................................ 16 
`
`EX1129:  Burstein AH, et al., Pharmacokinetics and
`Pharmacodynamics of Midazolam After Intranasal Administration
`(1997)
` ......................................................................................................... 16 
`
`FRE 802 (hearsay without exception) ........................................................... 16 
`
`FRE 105 (limited purpose) ............................................................................ 16 
`
`EX1130:  Wermeling D, et al., Pharmacokinetics and
`Pharmacodynamics of a new Intranasal Midazolam Formulation
`(2006)
` ......................................................................................................... 16 
`
`FRE 802 (hearsay without exception) ........................................................... 16 
`
`FRE 105 (limited purpose) ............................................................................ 16 
`
`EX1131:  Schols-Hendriks MwG, et al., Absorption of Clonazepam
`After Intranasal and Buccal Administration (1995) ..................................... 17 
`
`FRE 802 (hearsay without exception) ........................................................... 17 
`
`FRE 105 (limited purpose) ............................................................................ 17 
`
`EX1134:  Wermeling DP, Bioavailability and Pharmacokinetics of
`Lorazepam (2001) ......................................................................................... 17 
`
`FRE 802 (hearsay without exception) ........................................................... 17 
`
`FRE 105 (limited purpose) ............................................................................ 17 
`
`EX1135:  Greenblatt D, et al., Pharmacokinetics and
`Pharmacodynamics of Single-Dose Triazolam (2005) ................................ 17 
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`FRE 802 (hearsay without exception) ........................................................... 17 
`
`FRE 105 (limited purpose) ............................................................................ 18 
`
`EX1136:  O’Regan M, et al., Nasal Rather than Rectal Benzodiazepines
`in the Management of Acute Childhood Seizures (2006) ............................ 18 
`
`FRE 802 (hearsay without exception) ........................................................... 18 
`
`FRE 105 (limited purpose) ............................................................................ 18 
`
`EX1137:  Mittal P, et al., Comparative Study of Intranasal Midazolam
`and Intravenous Diazepam (2006) ................................................................ 18 
`
`FRE 802 (hearsay without exception) ........................................................... 18 
`
`FRE 105 (limited purpose) ............................................................................ 18 
`
`EX1138:  Mahmoudian T, et al., Comparison of Intranasal Midazolam
`with Intravenous Diazepam (2004) .............................................................. 19 
`
`FRE 802 (hearsay without exception) ........................................................... 19 
`
`FRE 105 (limited purpose) ............................................................................ 19 
`
`EX1139:  Lahat E, Comparison of Intranasal Midazolam with
`Intravenous Diazepam (2000) ...................................................................... 19 
`
`FRE 802 (hearsay without exception) ........................................................... 19 
`
`FRE 105 (limited purpose) ............................................................................ 19 
`
`EX1140:  Bhattacharyya M, et al., Intranasal Midazolam vs Rectal
`Diazepam (2006) .......................................................................................... 19 
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`FRE 802 (hearsay without exception) ........................................................... 19 
`
`FRE 105 (limited purpose) ............................................................................ 19 
`
`EX1141:  Wilson MT, et al., Nasal/Buccal Midazolam Use in the
`Community (2004) ........................................................................................ 20 
`
`FRE 802 (hearsay without exception) ........................................................... 20 
`
`FRE 105 (limited purpose) ............................................................................ 20 
`
`EX1142:  Harbord MG, et al., Use of Intranasal Midazolam to Treat
`Acute Seizures (2004)................................................................................... 20 
`
`FRE 802 (hearsay without exception) ........................................................... 20 
`
`FRE 105 (limited purpose) ............................................................................ 20 
`
`Jeannet PY, et al., Home and Hospital Treatment of Acute
`EX1143: 
`Seizures in Children with Nasal Midazolam (1999) .................................... 20 
`
`FRE 802 (hearsay without exception) ........................................................... 20 
`
`FRE 105 (limited purpose) ............................................................................ 21 
`
`EX1144:  Ahmad S, et al., Efficacy and Safety of Intranasal Lorazepam
`vs. Intramuscular Paraldehyde (2006) .......................................................... 21 
`
`FRE 802 (hearsay without exception) ........................................................... 21 
`
`FRE 105 (limited purpose) ............................................................................ 21 
`
`EX1145:  Wolfe T, et al., Intranasal Drug Delivery (2004) ........................... 21 
`
`FRE 802 (hearsay without exception) ........................................................... 21 
`
`FRE 105 (limited purpose) ............................................................................ 21 
`
`EX1146:  FDA GUI FINAL ............................................................................ 21 
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`FRE 802 (hearsay without exception) ........................................................... 21 
`
`FRE 901 (authentication) ............................................................................... 22 
`
`FRE 105 (limited purpose) ............................................................................ 22 
`
`EX1147:  CDER 2019 Abbreviated Approval Products ................................. 22 
`
`FRE 802 (hearsay without exception) ........................................................... 22 
`
`FRE 901 (authentication) ............................................................................... 22 
`
`FRE 105 (limited purpose) ............................................................................ 22 
`
`EX1148:  FDA Guidance for Industry (1999) ................................................ 22 
`
`FRE 802 (hearsay without exception) ........................................................... 22 
`
`FRE 901 (authentication) ............................................................................... 23 
`
`FRE 105 (limited purpose) ............................................................................ 23 
`
`EX1150:  Wermeling Declaration ................................................................... 23 
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`FRE 402 (relevance) ...................................................................................... 23 
`
`FRE 403 (prejudice, confusion, waste) ......................................................... 23 
`
`FRE 602 (personal knowledge) ..................................................................... 23 
`
`FRE 701 (improper lay testimony); 702 (unqualified expert testimony) ...... 23 
`
`FRE 802 (hearsay without exception) ........................................................... 24 
`
`FRE 805 (hearsay within hearsay) ................................................................. 24 
`
`FRE 1006 (summary to prove content) ......................................................... 24 
`
`FRE 105 (limited purpose) ............................................................................ 24 
`
`EX1151:  Wermeling DP, Intranasal Delivery of Antiepileptic
`Medications for Treatment of Seizures (2009) ............................................. 25 
`
`FRE 802 (hearsay without exception) ........................................................... 25 
`
`FRE 105 (limited purpose) ............................................................................ 25 
`
`Certificate of Service ............................................................................................... 26 
`
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`The patent owner (“Neurelis”) submits the following objections to post-
`
`institution evidence of the petitioner (“Aquestive”).
`
`I.
`
`
`
`OBJECTIONS
`EX1065: MAGGIO, PROVISIONAL APPLICATION NO. 60/632,038
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`The exhibit is not cited in the petitioner’s reply 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)
`To the extent this exhibit is used to prove the truth of the matter asserted, it
`
`
`
`is hearsay without meeting any hearsay exception.
`
`EX1069: FLORIDA REGIONAL COMMON EMS PROTOCOLS FIELD
`GUIDE (2005)
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`To the extent this exhibit is used for purposes of adding new invalidity
`
`
`
`combination it is not relevant to any ground of invalidity upon which trial was
`
`instituted.
`
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
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`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
`
`
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`it was offered in the petitioner’s reply.
`
`EX1070: GIZURARSON, U.S. PATENT APPLICATION NO.
`2008/0275030 (2008)
`FRE 105 (limited purpose)
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`
`
`it was offered in the petitioner’s reply.
`
`EX1072: NAYZILAM PRODUCT LABEL
`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
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`it was offered in the petitioner’s reply.
`
`EX1074: GOODMAN & GILMAN’S, THE PHARMACEUTICAL BASIS
`OF THERAPEUTICS (2001)
`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 petitioner’s reply.
`
`EX1076: THE MERCK INDEX (1996)
`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
`
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`it was offered in the petitioner’s reply.
`
`EX1077: RITCHEL WA, ET AL., HANDBOOK OF BASIC
`PHARMACOKINETICS (2004)
`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 petitioner’s reply.
`
`EX1078: USP/NF 2003, ETHANOL (2002)
`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
`
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`it was offered in the petitioner’s reply.
`
`EX1080: VALIUM® TABLET LABEL (2008)
`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 petitioner’s reply. 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 there is danger that it will lead to unfair prejudice if
`
`used later in the proceeding or on appeal.
`
`EX1081: DRUG PRICES
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`This exhibit is dated January 24, 2020 and therefore is not relevant to any
`
`
`
`ground of invalidity upon which trial was instituted.
`
`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 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 petitioner’s reply.
`
`EX1082: CHIEN YW, ET AL., NASAL SYSTEMIC DRUG DELIVERY
`(1989)
`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 petitioner’s reply.
`
`EX1101: LOWENSTEIN DH, ET AL., STATUS EPILIPTICUS (1998)
`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 petitioner’s reply.
`
`EX1102: LOWENSTEIN DH, ET AL., IT’S TIME TO REVISE THE
`DEFINITION OF STATUS EPILEPTICUS (1999)
`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 petitioner’s reply.
`
`EX1103: WANG HC, ET AL. FACTORS PREDICTIVE OF OUTCOME
`IN POSTTRAUMATIC SEIZURES (2008)
`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 petitioner’s reply.
`
`EX1104:
`STAVEM K, ET AL., LONG-TERM SEIZURES AND QUALITY
`OF LIFE AFTER EPILEPSY SURGERY (2008)
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`-7-
`IPR2019-0045
`
`
`
`
`

`

`
`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 petitioner’s reply.
`
`EX1105: LOGROSCINO G, ET AL., TIME TRENDS IN INCIDENCE,
`MORTALITY, AND CASE-FATALITY AFTER FIRST EPISODE OF
`STATUS EPILEPTICUS (2001)
`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 petitioner’s reply.
`
`EX1106: FEEN ES, ET AL., STATUS EPILEPTICUS (2008)
`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 petitioner’s reply.
`
`
`
`-8-
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`IPR2019-0045
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`
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`
`
`EX1107: PANG T, ET AL., TREATMENT OF CONVULSIVE AND
`NONCONVULSIVE STATUS EPILEPTICUS (2005)
`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 petitioner’s reply.
`
`EX1108:
`SMITH B, TREATMENT OF STATUS EPILEPTICUS (2001)
`FRE 802 (hearsay without exception)
`The exhibit is offered to prove the truth of the matter asserted without
`
`
`
`meeting any hearsa