`
`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
`
`U.S. Patent No. 9,763,876
`
`______________________
`
`
`
`PETITIONER’S OBJECTIONS
`
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`TABLE OF CONTENTS
`
`OBJECTIONS ............................................................................................................ 1
`Exhibit 2001: Epilepsy Fast Facts, CDC, 2019 ................................................... 1
`
`FRE 802 (hearsay without exception) ............................................................... 1
`
`FRE 901 (authentication) ................................................................................... 1
`
`FRE 105 (limited purpose) ................................................................................. 1
`
`Exhibit 2002: Grant Fast Track (diazepam intranasal solution), 2016. .............. 2
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) .......................... 2
`
`FRE 802 (hearsay without exception) ............................................................... 2
`
`FRE 105 (limited purpose) ................................................................................. 2
`
`Exhibit 2003: LeWine, “. . .Injection Helps Stop Epileptic Seizures,” 2012 ..... 2
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) .......................... 2
`
`FRE 802 (hearsay without exception) ............................................................... 3
`
`FRE 105 (limited purpose) ................................................................................. 3
`
`Exhibit 2004: “Managing Epilepsy . . .” CDC , 2016 .......................................... 3
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) .......................... 3
`
`FRE 802 (hearsay without exception) ............................................................... 3
`
`i
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 901 (authentication) ................................................................................... 4
`
`FRE 105 (limited purpose) ................................................................................. 4
`
`Exhibit 2005: Fiest, “Prevalence and Incidence of Epilepsy. . .”, 2017 ............. 4
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) .......................... 4
`
`FRE 802 (hearsay without exception) ............................................................... 4
`
`FRE 105 (limited purpose) ................................................................................. 4
`
`Exhibit 2006: SIGMA Chemical Company Catalog, 1988 ................................. 5
`
`FRE 802 (hearsay without exception) ............................................................... 5
`
`FRE 901 (authentication) ................................................................................... 5
`
`FRE 105 (limited purpose) ................................................................................. 5
`
`Exhibit 2007: Bechgaard, “Solubilization of . . . Benzodiazepines . . .”, 1997 . 5
`
`FRE 802 (hearsay without exception) ............................................................... 5
`
`FRE 105 (limited purpose) ................................................................................. 5
`
`Exhibit 2008: Hussain, “Nasal Absorption of Propranolol . . .”, 1980 .............. 6
`
`FRE 802 (hearsay without exception) ............................................................... 6
`
`FRE 105 (limited purpose) ................................................................................. 6
`
`Exhibit 2009: Lau, “Absorption of Diazepam and Lorazepam . . .”, 1989 ....... 6
`
`ii
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 802 (hearsay without exception) ............................................................... 6
`
`FRE 105 (limited purpose) ................................................................................. 6
`
`Exhibit 2010: Schols-Hendriks, “Absorption of Clonazepam …”, 1995 ........... 6
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) .......................... 6
`
`FRE 802 (hearsay without exception) ............................................................... 7
`
`FRE 105 (limited purpose) ................................................................................. 7
`
`Exhibit 2012: Declaration of Dr. Sveinbjorn Gizurarson, Ph.D. ........................ 7
`
`FRE 602 (personal knowledge) ......................................................................... 7
`
`FRE 701 (improper lay testimony); 702 (unqualifed expert testimony) ........... 8
`
`FRE 802 (hearsay without exception) ............................................................... 8
`
`FRE 1006 (summary to prove content) .............................................................. 8
`
`FRE 105 (limited purpose) ................................................................................. 8
`
`Exhibit 2013: Riss, “Benzodiazepines in Epilepsy . . .”, 2008 ........................... 9
`
`FRE 802 (hearsay without exception) ............................................................... 9
`
`FRE 105 (limited purpose) ................................................................................. 9
`
`Exhibit 2014: Wermeling, U.S. Patent No. 6,610,271, 2003 ............................. 9
`
`FRE 802 (hearsay without exception) ............................................................... 9
`
`iii
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 105 (limited purpose) ................................................................................. 9
`
`Exhibit 2015: Cole, “. . . Individual Epilepsy Guidelines . . .”, 2009 ................ 9
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) .......................... 9
`
`FRE 802 (hearsay without exception) .............................................................10
`
`FRE 105 (limited purpose) ...............................................................................10
`
`Exhibit 2016: Terry, “... Rectal Gel in School and Day Care Settings,” 2007 .10
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................10
`
`FRE 802 (hearsay without exception) .............................................................10
`
`FRE 105 (limited purpose) ...............................................................................11
`
`Exhibit 2017: Diastat® Label, 2005 ..................................................................11
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................11
`
`FRE 802 (hearsay without exception) .............................................................11
`
`FRE 901 (authentication) .................................................................................11
`
`Exhibit 2018: “NAYZILAM® (midazolam) . . . approved by FDA. . .”, 2019 .12
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................12
`
`FRE 802 (hearsay without exception) .............................................................12
`
`FRE 901 (authentication) .................................................................................12
`
`iv
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`Exhibit 2019: French, “Initial Management of Epilepsy,” 2008 ......................12
`
`FRE 802 (hearsay without exception) .............................................................12
`
`Exhibit 2020: Corbo, “Measurement of Nasal Mucociliary Clearance,” 1989 13
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................13
`
`FRE 802 (hearsay without exception) .............................................................13
`
`Exhibit 2021: “How does the nose work? The nasal mucosa,” 2019 ................14
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................14
`
`FRE 802 (hearsay without exception) .............................................................14
`
`FRE 901 (authentication) .................................................................................14
`
`Exhibit 2022: Mygind, “Nasal Allergy,” 1979 .................................................15
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................15
`
`FRE 802 (hearsay without exception) .............................................................15
`
`Exhibit 2023: “Neurelis Files New Drug Application . . .” 2019 .....................15
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................15
`
`FRE 802 (hearsay without exception) .............................................................16
`
`FRE 901 (authentication) .................................................................................16
`
`Exhibit 2024: “Neurelis Receives FDA Orphan Drug Designation…”, 2019 .16
`
`v
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice) ........................16
`
`FRE 802 (hearsay without exception) .............................................................16
`
`FRE 901 (authentication) .................................................................................17
`
`
`
`
`
`
`
`vi
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`OBJECTIONS
`
`
`
`Petitioner, Aquestive Therapeutics, Inc. submits the following objections to
`
`evidence of the Patent Owner, Neurelis, Inc.
`
`Exhibit 2001: Epilepsy Fast Facts, CDC, 2019
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit 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
`
`the Board’s and the Petitioner’s 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)
`
`Patent Owner 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 Patent Owner’s Preliminary Response and Patent Owner’s
`
`Response.
`
`1
`
`
`
`
`
`
`IPR2019-00451
`
`
`Exhibit 2002: Grant Fast Track (diazepam intranasal solution), 2016.
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit 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
`
`the Board’s and the Petitioner’s 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 Patent Owner’s Preliminary Response and Patent Owner’s
`
`Response.
`
`Exhibit 2003: LeWine, “. . .Injection Helps Stop Epileptic Seizures,” 2012
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response 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 the Board’s and the Petitioner’s
`
`2
`
`
`
`
`
`
`IPR2019-00451
`
`
`time, and the danger that it will lead to unfair prejudice if used later in the
`
`
`
`U.S. Patent No. 9,763,876
`
`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 Patent Owner’s Preliminary Response and Patent Owner’s
`
`Response.
`
`Exhibit 2004: “Managing Epilepsy . . .” CDC , 2016
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit 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
`
`the Board’s and the Petitioner’s 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.
`
`
`
`3
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`FRE 901 (authentication)
`
`
`
`U.S. Patent No. 9,763,876
`
`Patent Owner 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 Patent Owner’s Preliminary Response and Patent Owner’s
`
`Response.
`
`Exhibit 2005: Fiest, “Prevalence and Incidence of Epilepsy. . .”, 2017
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit 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
`
`the Board’s and the Petitioner’s 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
`
`4
`
`
`
`
`
`
`IPR2019-00451
`
`
`it was offered in Patent Owner’s Preliminary Response and Patent Owner’s
`
`
`
`U.S. Patent No. 9,763,876
`
`Response.
`
`Exhibit 2006: SIGMA Chemical Company Catalog, 1988
`
`
`
`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)
`
`Patent Owner 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 Patent Owner’s Preliminary Response and Patent Owner’s
`
`Response.
`
`Exhibit 2007: Bechgaard, “Solubilization of . . . Benzodiazepines . . .”, 1997
`
`
`
`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
`
`5
`
`
`
`
`
`
`IPR2019-00451
`
`
`it was offered in Patent Owner’s Response.
`
`
`
`U.S. Patent No. 9,763,876
`
`Exhibit 2008: Hussain, “Nasal Absorption of Propranolol . . .”, 1980
`
`
`
`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 Patent Owner’s Response.
`
`Exhibit 2009: Lau, “Absorption of Diazepam and Lorazepam . . .”, 1989
`
`
`
`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 Patent Owner’s Response.
`
`Exhibit 2010: Schols-Hendriks, “Absorption of Clonazepam …”, 1995
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response and is not relevant to any
`
`instituted ground. The exhibit’s probative value is substantially outweighed by its
`
`6
`
`
`
`
`
`
`IPR2019-00451
`
`
`confusion of the issues to be decided, its waste of the Board’s and the Petitioner’s
`
`U.S. Patent No. 9,763,876
`
`
`
`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 Patent Owner’s Response.
`
`Exhibit 2012: Declaration of Dr. Sveinbjorn Gizurarson, Ph.D.
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`Paragraphs 2, 5, 7, 67 are not relevant to any instituted ground and their probative
`
`value is substantially outweighed by its confusion of the issues to be decided, its
`
`waste of the Board’s and the Petitioner’s time, and the danger that it will lead to
`
`unfair prejudice if used later in the proceeding or on appeal.
`
`
`
`FRE 602 (personal knowledge)
`
`Paragraphs 2, 3, 5, 28-33, 36, 44, 48, 50-51 include assertions for which evidence
`
`has not been introduced sufficient to show that the witness has personal knowledge
`
`of the matters asserted.
`
`7
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 701 (improper lay testimony); 702 (unqualifed expert testimony)
`
`For paragraphs 16-25, 26, 28, 31-36, 38-39, 41-43, 48, 50-52, 54-56, 58, 60-61,
`
`67-70, 75, 77-80, 82-87, 89-95, 97, 99-109, 111-116, the declarant is not qualified
`
`to opine on what a person of ordinary skill in the art would understand, to opine on
`
`patent claim limitations, to perform claim construction, and/or to perform legal
`
`analysis of patent invalidity. The opinion testimony offered in this exhibit is not
`
`based on scientific, technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes unsubstantiated leaps and
`
`advances inaccurate, unqualified generalizations.
`
`
`
`FRE 802 (hearsay without exception)
`
`For paragraphs 28-33, 44-46, 48, 50-52, 54, 56-61, 63-67, 71-72, 74, 77-78, 83-
`
`84, 89, 92, 111-113, the exhibit is offered to prove the truth of the matter asserted
`
`without meeting any hearsay exception.
`
`
`
`FRE 1006 (summary to prove content)
`
`Paragraphs 28-29, 36, 48, 50-51, 56, 58, 59-60, 79, 85, 87, 89, 95, 100-102, 104-
`
`105, 109, 114-116 constitute improper summary with underlying documents not
`
`made available.
`
`
`
`FRE 105 (limited purpose)
`
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`8
`
`
`
`
`
`
`IPR2019-00451
`
`
`it was offered in Patent Owner’s Response.
`
`
`
`U.S. Patent No. 9,763,876
`
`Exhibit 2013: Riss, “Benzodiazepines in Epilepsy . . .”, 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 Patent Owner’s Response.
`
`Exhibit 2014: Wermeling, U.S. Patent No. 6,610,271, 2003
`
`
`
`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 Patent Owner’s Response.
`
`Exhibit 2015: Cole, “. . . Individual Epilepsy Guidelines . . .”, 2009
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response and is not relevant to any
`
`instituted ground. The exhibit’s probative value is substantially outweighed by its
`
`9
`
`
`
`
`
`
`IPR2019-00451
`
`
`confusion of the issues to be decided, its waste of the Board’s and the Petitioner’s
`
`U.S. Patent No. 9,763,876
`
`
`
`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 Patent Owner’s Response.
`
`Exhibit 2016: Terry, “... Rectal Gel in School and Day Care Settings,” 2007
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response 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 the Board’s and the Petitioner’s
`
`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.
`
`10
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`FRE 105 (limited purpose)
`
`
`
`U.S. Patent No. 9,763,876
`
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in Patent Owner’s Response.
`
`Exhibit 2017: Diastat® Label, 2005
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response 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 the Board’s and the Petitioner’s
`
`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)
`
`Patent Owner 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 Patent Owner’s Response.
`
`11
`
`
`
`
`
`
`IPR2019-00451
`
`
`Exhibit 2018: “NAYZILAM® (midazolam) . . . approved by FDA. . .”, 2019
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit 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
`
`the Board’s and the Petitioner’s 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)
`
`Patent Owner 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 Patent Owner’s Response.
`
`Exhibit 2019: French, “Initial Management of Epilepsy,” 2008
`
`
`
`FRE 802 (hearsay without exception)
`
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`12
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`FRE 105 (limited purpose)
`
`
`
`U.S. Patent No. 9,763,876
`
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in Patent Owner’s Response.
`
`Exhibit 2020: Corbo, “Measurement of Nasal Mucociliary Clearance,” 1989
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response 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 the Board’s and the Petitioner’s
`
`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 Patent Owner’s Response.
`
`
`
`
`
`
`
`13
`
`
`
`
`
`
`IPR2019-00451
`
`
`Exhibit 2021: “How does the nose work? The nasal mucosa,” 2019
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response 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 the Board’s and the Petitioner’s
`
`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)
`
`Patent Owner 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 Patent Owner’s Response.
`
`
`
`
`
`
`
`14
`
`
`
`
`
`
`IPR2019-00451
`
`
`Exhibit 2022: Mygind, “Nasal Allergy,” 1979
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit is not cited in Patent Owner’s Response 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 the Board’s and the Petitioner’s
`
`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 Patent Owner’s Response.
`
`Exhibit 2023: “Neurelis Files New Drug Application . . .” 2019
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit 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
`
`the Board’s and the Petitioner’s time, and the danger that it will lead to unfair
`
`prejudice if used later in the proceeding or on appeal.
`
`15
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`FRE 802 (hearsay without exception)
`
`
`
`U.S. Patent No. 9,763,876
`
`The exhibit is offered to prove the truth of the matter asserted without
`
`meeting any hearsay exception.
`
`
`
`FRE 901 (authentication)
`
`Patent Owner 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 Patent Owner’s Response.
`
`Exhibit 2024: “Neurelis Receives FDA Orphan Drug Designation…”, 2019
`
`
`
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`The exhibit 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
`
`the Board’s and the Petitioner’s 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.
`
`
`
`16
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`FRE 901 (authentication)
`
`
`
`U.S. Patent No. 9,763,876
`
`Patent Owner 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 Patent Owner’s Response.
`
`
`Dated: November 13, 2019.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
`
`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
`
`
`
`First Backup Counsel for
`Petitioner Aquestive Therapeutics, Inc.
`
`17
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on this the 13th day of November 2019, the foregoing
`
`PETITIONER’S OBJECTIONS PURSUANT TO 37 C.F.R. § 42.64(b)(1) was
`
`served in its entirety on the following counsel of record by electronic service by
`
`email at the email addresses as set forth below.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 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
`
`
`
`
`By:
`/Michael I. Chakansky/
`
`
`Michael I. Chakansky (Reg. No. 31,600)
`
`
`Hoffmann & Baron, LLP
`
`
`4 Century Drive
`
`
`
`Parsippany, N.J. 07054
`
`
`mchakansky@hbiplaw.com
`
`
`Tel: 973.331.1700
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`18
`
`
`
`
`
`
`IPR2019-00451
`
`
`
`
`
`U.S. Patent No. 9,763,876
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on this the 19th day of November 2019, the foregoing
`
`PETITIONER’S OBJECTIONS PURSUANT TO 37 C.F.R. § 42.64(b)(1) was
`
`served in its entirety on the following counsel of record by electronic service by
`
`email at the email addresses as set forth below.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 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
`
`
`
`
`By:
`/Michael I. Chakansky/
`
`
`Michael I. Chakansky (Reg. No. 31,600)
`
`
`Hoffmann & Baron, LLP
`
`
`4 Century Drive
`
`
`
`Parsippany, N.J. 07054
`
`
`mchakansky@hbiplaw.com
`
`
`Tel: 973.331.1700
`
`
`
`
`
`
`
`
`
`
`
`
`19
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
