Case No. 21-1038
`Eluiteb iptateg Court of ZippeaW
`for the jfeberat Circuit
`NEURELIS, INC.,
`Appellant,
`v.
`AQUESTIVE THERAPEUTICS, INC.,
`Appellee.
`Appeal from a decision of the United States Patent and Trademark Office,
`Patent Trial and Appeal Board in IPR2019-00451
`APPELLANT NEURELIS INC.'S OPENING BRIEF
`Wendy Devine
`WILSON SONSINI GOODRICH & ROSATI
`One Market Plaza, Spear Tower, Suite 3300
`San Francisco, CA 94105-1126
`(415) 947-2027
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, 5th Floor
`Washington, DC 20006-3817
`(202) 973-8811
`February 2, 2021
`Jeffrey Guise
`Lorelei Westin
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`San Diego, CA 92130-3002
`(858) 350-2300
`Counsel for Appellant
`Neurelis, Inc.
`Case No. 21-1038
`United States Court of Appeals
`for the Federal Circuit
`NEURELIS, INC.,
`Appellant,
`v.
`AQUESTIVE THERAPEUTICS, INC.,
`Appellee.
`Appeal from a decision of the United States Patent and Trademark Office,
`Patent Trial and Appeal Board in IPR2019-00451
`APPELLANT NEURELIS INC.’S OPENING BRIEF
`Wendy Devine
`WILSON SONSINI GOODRICH & ROSATI
`One Market Plaza, Spear Tower, Suite 3300
`San Francisco, CA 94105-1126
`(415) 947-2027
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, 5th Floor
`Washington, DC 20006-3817
`(202) 973-8811
`Jeffrey Guise
`Lorelei Westin
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`San Diego, CA 92130-3002
`(858) 350-2300
`February 2, 2021
`Counsel for Appellant
`Neurelis, Inc.
`Case: 21-1038 Document: 16 Page: 1 Filed: 02/02/2021
`Padagis US LLC, EX1081
`
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`
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`REPRESENTATIVE CLAIMS
`1. A method of treating a patient with a disorder which is treatable
`with a benzodiazepine drug, comprising: administering to one or more
`nasal mucosal membranes of a patient a pharmaceutical solution for
`nasal administration consisting of a benzodiazepine drug, one or more
`natural or synthetic tocopherols or tocotrienols, or any combinations
`thereof, in an amount from about 30% to about 95% (w/w); ethanol
`and benzyl alcohol in a combined amount from about 10% to about
`70% (w/w); and an alkyl glycoside.
`27. The method of claim 1, wherein the solution consists of
`diazepam, vitamin E, ethanol, benzyl alcohol and dodecyl maltoside.
`28. The method of claim 1, wherein the solution consists of about
`56.47% (w/v) vitamin E, about 10.5% (w/v) benzyl alcohol, about
`10% (w/v) diazepam, about 0.25%(w/v) dodecyl maltoside, q.s.
`dehydrated ethanol.
`30. The method of claim 1, wherein the solution consists of
`diazepam from 5 to 15% (w/v), dodecyl maltoside from about 0.01 to
`1% (w/v) , vitamin E from 45 to 65% (w/v), ethanol from 10 to 25%
`(w/v) and benzyl alcohol from 5 to 15% (w/v).
`31. The method of claim 1, wherein the solution consists of
`diazepam from 5 to 15% (w/v), dodecyl maltoside from 0.01 to 1%
`(w/v), vitamin E from 45 to 65% (w/v), ethanol from 10 to 25%
`(w/v)and benzyl alcohol from 5 to 15% (w/v).
`32. The method of claim 1, wherein the solution consists of
`diazepam from 9 to 11% (w/v), dodecyl maltoside from 0.1 to 0.5%
`(w/v), vitamin E from 50 to 60% (w/v), ethanol from 15 to 22.5%
`(w/v) and benzyl alcohol from 7.5 to 12.5% (w/v).
`33. The method of claim 1, wherein the solution consists of
`diazepam 10% (w/v), dodecyl maltoside from 0.15 to 0.3% (w/v),
`vitamin E from 50 to 60% (w/v), ethanol from 17 to 20% (w/v) and
`benzyl alcohol from 10 to 12% (w/v).
`(underlining added)
`[inside cover] [inside cover]
`REPRESENTATIVE CLAIMS
`1. A method of treating a patient with a disorder which is treatable
`with a benzodiazepine drug, comprising: administering to one or more
`nasal mucosal membranes of a patient a pharmaceutical solution for
`nasal administration consisting of a benzodiazepine drug, one or more
`natural or synthetic tocopherols or tocotrienols, or any combinations
`thereof, in an amount from about 30% to about 95% (w/w); ethanol
`and benzyl alcohol in a combined amount from about 10% to about
`70% (w/w); and an alkyl glycoside.
`27. The method of claim 1, wherein the solution consists of
`diazepam, vitamin E, ethanol, benzyl alcohol and dodecyl maltoside.
`28. The method of claim 1, wherein the solution consists of about
`56.47% (w/v) vitamin E, about 10.5% (w/v) benzyl alcohol, about
`10% (w/v) diazepam, about 0.25%(w/v) dodecyl maltoside, q.s.
`dehydrated ethanol.
`30. The method of claim 1, wherein the solution consists of
`diazepam from 5 to 15% (w/v), dodecyl maltoside from about 0.01 to
`1% (w/v) , vitamin E from 45 to 65% (w/v), ethanol from 10 to 25%
`(w/v) and benzyl alcohol from 5 to 15% (w/v).
`31. The method of claim 1, wherein the solution consists of
`diazepam from 5 to 15% (w/v), dodecyl maltoside from 0.01 to 1%
`(w/v), vitamin E from 45 to 65% (w/v), ethanol from 10 to 25%
`(w/v)and benzyl alcohol from 5 to 15% (w/v).
`32. The method of claim 1, wherein the solution consists of
`diazepam from 9 to 11% (w/v), dodecyl maltoside from 0.1 to 0.5%
`(w/v), vitamin E from 50 to 60% (w/v), ethanol from 15 to 22.5%
`(w/v) and benzyl alcohol from 7.5 to 12.5% (w/v).
`33. The method of claim 1, wherein the solution consists of
`diazepam 10% (w/v), dodecyl maltoside from 0.15 to 0.3% (w/v),
`vitamin E from 50 to 60% (w/v), ethanol from 17 to 20% (w/v) and
`benzyl alcohol from 10 to 12% (w/v).
`(underlining added)
`Case: 21-1038 Document: 16 Page: 2 Filed: 02/02/2021
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`CERTIFICATE OF INTEREST
`Pursuant to Federal Circuit Rule 47.4, counsel for Appellant Neurelis, Inc.
`certifies that:
`1. The full name of every entity represented by me is: Neurelis, Inc.
`2. The full names of all real parties in interest for the entity, if that entity
`is not the real party in interest, are: None.
`3. The full names of all parent corporations for the entity and all publicly
`held companies that own 10% or more stock in the entity is: None.
`4. The names of all law firms, partners, and associates that (a) appeared
`for the entity in the originating agency or (b) are expected to appear in this court
`for the entity are: Lee Johnson, Alina Litoshyk, and Nathaniel Leachman.
`5. The case titles and numbers of any case known to be pending in this
`court or any other court or agency that will directly affect or be directly affected by
`this court's decision in the pending appeals is: None.
`6. Information required under Fed. R. App. P. 26.1(b) (organizational
`victims in criminal cases) and 26.1(c) (bankruptcy case debtors and trustees) is:
`None.
`Dated: February 2, 2021 /s/Jeffrey Guise
`Jeffrey Guise
`WILSON SONSINI GOODRICH & ROSATI
`Counsel for Appellant Neurelis, Inc.
`i i
`CERTIFICATE OF INTEREST
` Pursuant to Federal Circuit Rule 47.4, counsel for Appellant Neurelis, Inc.
`certifies that:
`1. The full name of every entity represented by me is: Neurelis, Inc.
`2. The full names of all real parties in interest for the entity, if that entity
`is not the real party in interest, are: None.
`3. The full names of all parent corporations for the entity and all publicly
`held companies that own 10% or more stock in the entity is: None.
`4. The names of all law firms, partners, and associates that (a) appeared
`for the entity in the originating agency or (b) are expected to appear in this court
`for the entity are: Lee Johnson, Alina Litoshyk, and Nathaniel Leachman.
`5. The case titles and numbers of any case known to be pending in this
`court or any other court or agency that will directly affect or be directly affected by
`this court's decision in the pending appeals is: None.
`6. Information required under Fed. R. App. P. 26.1(b) (organizational
`victims in criminal cases) and 26.1(c) (bankruptcy case debtors and trustees) is:
`None.
`Dated: February 2, 2021 /s/Jeffrey Guise
`Jeffrey Guise
`WILSON SONSINI GOODRICH & ROSATI
`Counsel for Appellant Neurelis, Inc.
`Case: 21-1038 Document: 16 Page: 3 Filed: 02/02/2021
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`TABLE OF CONTENTS
`Page
`STATEMENT OF RELATED CASES vii
`JURISDICTIONAL STATEMENT viii
`STATEMENT OF THE ISSUES 1
`INTRODUCTION 1
`STATEMENT OF THE CASE 2
`A. Technical Background 2
`B. Neurelis' Priority Claim 5
`C. The Inter Partes Review 7
`SUMMARY OF THE ARGUMENT 13
`ARGUMENT 16
`A. Legal Standards 16
`B. The Board Erred in Denying Neurelis its Claimed Priority Date;
`Thus Erroneously Concluding Gwozdz Was Prior Art 19
`1. The '558 provisional application properly incorporated
`the SIGMA catalog by reference 21
`2. The Board erroneously required a preference for alkyl
`glycosides, rather than simple possession 23
`3. The '558 provisional application provided explicit blaze
`marks to the alkyl glycosides in the SIGMA catalog 26
`4. Aquestive's references are not prior art 31
`5. The delayed presentation of the issue was prejudicial 31
`ii ii
`TABLE OF CONTENTS
`Page
`STATEMENT OF RELATED CASES .................................................................. vii
`JURISDICTIONAL STATEMENT ...................................................................... viii
`STATEMENT OF THE ISSUES............................................................................... 1
`INTRODUCTION ..................................................................................................... 1
`STATEMENT OF THE CASE .................................................................................. 2
`A. Technical Background ................................................................................ 2
`B. Neurelis’ Priority Claim ............................................................................. 5
`C. The Inter Partes Review ............................................................................. 7
`SUMMARY OF THE ARGUMENT ...................................................................... 13
`ARGUMENT ........................................................................................................... 16
`A. Legal Standards ........................................................................................ 16
`B. The Board Erred in Denying Neurelis its Claimed Priority Date;
`Thus Erroneously Concluding Gwozdz Was Prior Art ............................ 19
`1. The ’558 provisional application properly incorporated
`the SIGMA catalog by reference ................................................... 21
`2. The Board erroneously required a preference for alkyl
`glycosides, rather than simple possession ...................................... 23
`3. The ’558 provisional application provided explicit blaze
`marks to the alkyl glycosides in the SIGMA catalog .................... 26
`4. Aquestive’s references are not prior art ......................................... 31
`5. The delayed presentation of the issue was prejudicial ................... 31
`Case: 21-1038 Document: 16 Page: 4 Filed: 02/02/2021
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`C. The Board Erroneously Construed Claims 26-28 and 30-33,
`Denying Priority Despite Explicit Disclosure, to Treat Gwozdz
`as Prior Art 34
`1. The Board's claim construction ignores the literal claim
`language and the disclosure of the '876 patent 37
`2. An accurate construction of dependent claims 26-28 and
`30-33 justifies priority to the provisional filing date 38
`3. Gwozdz is not prior art to dependent claims 26-28 and
`30-33 40
`D. The Board Erred by Holding the Claims Obvious 40
`1. Grounds for The Board's Unpatentability Decision and
`the Relied Upon Prior Art 41
`2. A POSA lacked a motivation to combine the references 42
`a. No motivation to modify Gwozdz; no expectation
`of success 43
`b. No motivation to combine Gwozdz with Meezan 45
`c. No motivation to combine with Cartt 47
`3. A POSA lacked a reasonable expectation of success 49
`4. Long -felt need and the failure of others confirms the
`nonobviousness of the '876 patent claims; and the
`Board's dismissal of that evidence was legal error 51
`REMEDY 55
`CONCLUSION 57
`ADDENDUM 59
`iii iii
`C. The Board Erroneously Construed Claims 26-28 and 30-33,
`Denying Priority Despite Explicit Disclosure, to Treat Gwozdz
`as Prior Art ................................................................................................ 34
`1. The Board’s claim construction ignores the literal claim
`language and the disclosure of the ’876 patent .............................. 37
`2. An accurate construction of dependent claims 26-28 and
`30-33 justifies priority to the provisional filing date ..................... 38
`3. Gwozdz is not prior art to dependent claims 26-28 and
`30-33 ............................................................................................... 40
`D. The Board Erred by Holding the Claims Obvious ................................... 40
`1. Grounds for The Board’s Unpatentability Decision and
`the Relied Upon Prior Art .............................................................. 41
`2. A POSA lacked a motivation to combine the references ............... 42
`a. No motivation to modify Gwozdz; no expectation
`of success .............................................................................. 43
`b. No motivation to combine Gwozdz with Meezan ................ 45
`c. No motivation to combine with Cartt .................................. 47
`3. A POSA lacked a reasonable expectation of success .................... 49
`4. Long-felt need and the failure of others confirms the
`nonobviousness of the ’876 patent claims; and the
`Board’s dismissal of that evidence was legal error ........................ 51
`REMEDY ................................................................................................................. 55
`CONCLUSION ........................................................................................................ 57
`ADDENDUM .......................................................................................................... 59
`Case: 21-1038 Document: 16 Page: 5 Filed: 02/02/2021
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`TABLE OF AUTHORITIES
`Pages
`Cases
`Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272
`(Fed. Cir. 2000) 18
`Allsteel Inc. v. DIRTT Envtl. Sol'ns Ltd., IPR2015-01690, Paper 13
`(PTAB 2016) 9
`Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.
`2010)
`Arthrex, Inc. v. Smith & Nephew, Inc., 935 F.3d 1319 (Fed. Cir.
`2019)
`passim
`33
`ATI Techs. ULC v. Iancu, 920 F.3d 1362 (Fed. Cir. 2019) 16
`Bayer AG v. Schein Pharms., Inc., 301 F.3d 1306 (Fed. Cir. 2002) 17
`Bayer Pharma AG v. Watson Labs., Inc., 874 F.3d 1316 (Fed. Cir.
`2017) 16
`Cuozzo Speed Technologies, LLC v. Lee, 579 U.S. _, 136 S. Ct.
`2131 (2016) 23, 55, 56
`Ex parte Maziere, 27 USPQ2d 1705 (BPAI 1993) 23
`Fred Beverages Inc. v. Fred's Capital Mgmt. Co., 605 F.3d 963
`(Fed. Cir. 2010) 19, 23
`Graham v. John Deere Co., 383 U.S. 1 (1966) 16
`Harari v. Hollmer, 602 F.3d 1348 (Fed. Cir. 2010) 18
`Harari v. Lee, 656 F.3d 1331, 1334 (Fed. Cir. 2011) 18
`Husky Injection Molding v. Athena Automation Ltd., 838 F.3d
`1236 (Fed. Cir. 2016) passim
`In re Alton, 76 F.3d 1168 (Fed. Cir. 1996) 17, 31, 32
`iv iv
`TABLE OF AUTHORITIES
`Pages
`Cases
`Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272
`(Fed. Cir. 2000) ...................................................................................................18
`Allsteel Inc. v. DIRTT Envtl. Sol’ns Ltd., IPR2015-01690, Paper 13
`(PTAB 2016) ......................................................................................................... 9
`Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.
`2010) ........................................................................................................... passim
`Arthrex, Inc. v. Smith & Nephew, Inc., 935 F.3d 1319 (Fed. Cir.
`2019) ...................................................................................................................33
`ATI Techs. ULC v. Iancu, 920 F.3d 1362 (Fed. Cir. 2019) .....................................16
`Bayer AG v. Schein Pharms., Inc., 301 F.3d 1306 (Fed. Cir. 2002) .......................17
`Bayer Pharma AG v. Watson Labs., Inc., 874 F.3d 1316 (Fed. Cir.
`2017) ...................................................................................................................16
`Cuozzo Speed Technologies, LLC v. Lee, 579 U.S. _, 136 S. Ct.
`2131 (2016) ............................................................................................ 23, 55, 56
`Ex parte Maziere, 27 USPQ2d 1705 (BPAI 1993) ..................................................23
`Fred Beverages Inc. v. Fred's Capital Mgmt. Co., 605 F.3d 963
`(Fed. Cir. 2010) ............................................................................................ 19, 23
`Graham v. John Deere Co., 383 U.S. 1 (1966) .......................................................16
`Harari v. Hollmer, 602 F.3d 1348 (Fed. Cir. 2010) ................................................18
`Harari v. Lee, 656 F.3d 1331, 1334 (Fed. Cir. 2011) ..............................................18
`Husky Injection Molding v. Athena Automation Ltd., 838 F.3d
`1236 (Fed. Cir. 2016). ................................................................................. passim
`In re Alton, 76 F.3d 1168 (Fed. Cir. 1996) ................................................. 17, 31, 32
`Case: 21-1038 Document: 16 Page: 6 Filed: 02/02/2021
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`In re Brower, 433 F.2d 813 (CCPA1970) 25
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012) 51, 52
`In re Edwards, 568 F.2d 1349 (CCPA 1978) 21, 26, 31
`In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) 16
`In re Global IP Holdings LLC, 927 F.3d 1373 (Fed. Cir. 2019) 17
`In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989) 17
`In re Lund, 376 F.2d 982 (CCPA 1967) 24
`In re NuVasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016) 18
`In re Stepan Co., 660 F.3d 1341 (Fed. Cir. 2011) 18
`M & K Holdings, Inc. v. Samsung Electronics Co., Ltd., No. 20-
`1160 (Fed. Cir. Feb. 1, 2021) 33
`Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356 (Fed. Cir.
`2017) 51
`Riverwood Intl Corp. v. R.A. Jones & Co., 324 F.3d 1346 (Fed.
`Cir. 2003) 16
`SAS Institute Inc. v. Iancu, 584 U.S. _, 138 S. Ct. 1348 (2018) 20
`Shea v. Willkie, 926 F.3d 1362 (Fed. Cir. 2019) 16
`Statutes
`5 U.S.C. §554 33
`28 U.S.C. §1295 viii
`35 U.S.C. §112 37
`35 U.S.C. §119 5, 22, 23
`v v
`In re Brower, 433 F.2d 813 (CCPA1970) ...............................................................25
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012) ............................................. 51, 52
`In re Edwards, 568 F.2d 1349 (CCPA 1978) ............................................. 21, 26, 31
`In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) .......................................................16
`In re Global IP Holdings LLC, 927 F.3d 1373 (Fed. Cir. 2019) .............................17
`In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989) .........................................................17
`In re Lund, 376 F.2d 982 (CCPA 1967) ..................................................................24
`In re NuVasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016) .............................................18
`In re Stepan Co., 660 F.3d 1341 (Fed. Cir. 2011) ...................................................18
`M & K Holdings, Inc. v. Samsung Electronics Co., Ltd., No. 20-
`1160 (Fed. Cir. Feb. 1, 2021) ..............................................................................33
`Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356 (Fed. Cir.
`2017) ...................................................................................................................51
`Riverwood Int'l Corp. v. R.A. Jones & Co., 324 F.3d 1346 (Fed.
`Cir. 2003) ............................................................................................................16
`SAS Institute Inc. v. Iancu, 584 U.S. _, 138 S. Ct. 1348 (2018) ..............................20
`Shea v. Willkie, 926 F.3d 1362 (Fed. Cir. 2019)......................................................16
`Statutes
`5 U.S.C. §554 ...........................................................................................................33
`28 U.S.C. §1295 ..................................................................................................... viii
`35 U.S.C. §112 .........................................................................................................37
`35 U.S.C. §119 .............................................................................................. 5, 22, 23
`Case: 21-1038 Document: 16 Page: 7 Filed: 02/02/2021
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`35 U.S.C. §120 23
`35 U.S.C. §141 viii
`35 U.S.C. §312 10
`35 U.S.C. §316(e) 32
`35 U.S.C. §318 viii
`Regulations
`37 C.F.R. §1.57 passim
`37 CFR §42.23(b) 33
`Guidance
`Consolidated Trial Practice Guide 73 (2019) 33
`Manual of Patent Examining Procedure §608.01 23
`vi vi
`35 U.S.C. §120 .........................................................................................................23
`35 U.S.C. §141 ....................................................................................................... viii
`35 U.S.C. §312 .........................................................................................................10
`35 U.S.C. §316(e) ....................................................................................................32
`35 U.S.C. §318 ....................................................................................................... viii
`Regulations
`37 C.F.R. §1.57 ................................................................................................ passim
`37 CFR §42.23(b) ....................................................................................................33
`Guidance
`Consolidated Trial Practice Guide 73 (2019) ..........................................................33
`Manual of Patent Examining Procedure §608.01 ....................................................23
`Case: 21-1038 Document: 16 Page: 8 Filed: 02/02/2021
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`STATEMENT OF RELATED CASES
`No other appeal in or from the same inter partes review was previously
`before this or any other appellate court. No other case is known to counsel to be
`pending in this or any other court or agency that will directly affect or be directly
`affected by this court's decision in the pending appeal.
`vii vii
`STATEMENT OF RELATED CASES
` No other appeal in or from the same inter partes review was previously
`before this or any other appellate court. No other case is known to counsel to be
`pending in this or any other court or agency that will directly affect or be directly
`affected by this court’s decision in the pending appeal.
`Case: 21-1038 Document: 16 Page: 9 Filed: 02/02/2021
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`JURISDICTIONAL STATEMENT
`The Patent Trial and Appeal Board ("Board") had jurisdiction to enter a final
`written decision under 35 U.S.C. §318(a). This Court has jurisdiction for direct
`review of the final written decision under 28 U.S.C. §1295(a)(4)(A) and 35 U.S.C.
`§141(c).
`viii viii
`JURISDICTIONAL STATEMENT
` The Patent Trial and Appeal Board (“Board”) had jurisdiction to enter a final
`written decision under 35 U.S.C. §318(a). This Court has jurisdiction for direct
`review of the final written decision under 28 U.S.C. §1295(a)(4)(A) and 35 U.S.C.
`§141(c).
`Case: 21-1038 Document: 16 Page: 10 Filed: 02/02/2021
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`STATEMENT OF THE ISSUES
`1. Did the Board prejudicially err in applying the wrong written-description
`standards to deny claims 1-36 of appellant Neurelis, Inc.'s U.S. Patent No.
`9,763,876 (the "876 patent") priority benefit to U.S. Provisional Patent
`Application Serial No. 61/040,558 (the "'558 provisional application")?
`2. Did the Board prejudicially err in misconstruing '876 patent claims 26-28
`and 30-33 as requiring generic "alkyl glycoside" rather than the claimed "dodecyl
`maltoside", and then denying these claims priority to the '558 provisional
`application, which discloses dodecyl maltoside as claimed?
`3. Did the Board prejudicially err in holding all '876 patent claims obvious?
`INTRODUCTION
`The Board prejudicially erred in holding claims 1-36 unpatentable for at
`least three reasons. First, the Board held the original priority document—the '558
`provisional application—lacked written description for the '876 patent claims'
`"alkyl glycoside" limitation. By repeatedly misapplying incorporation-by-reference
`law, the Board failed to recognize express possession of listed alkyl glycosides in
`the specification. Moreover, the Board improperly required a preference for "alkyl
`glycosides" rather than simple possession. Second, the Board overlooked the
`"dodecyl maltoside" limitations in dependent claims 26-28 and 30-33, which have
`1 1
`STATEMENT OF THE ISSUES
`1. Did the Board prejudicially err in applying the wrong written-description
`standards to deny claims 1-36 of appellant Neurelis, Inc.’s U.S. Patent No.
`9,763,876 (the “’876 patent”) priority benefit to U.S. Provisional Patent
`Application Serial No. 61/040,558 (the “’558 provisional application”)?
`2. Did the Board prejudicially err in misconstruing ’876 patent claims 26-28
`and 30-33 as requiring generic “alkyl glycoside” rather than the claimed “dodecyl
`maltoside”, and then denying these claims priority to the ’558 provisional
`application, which discloses dodecyl maltoside as claimed?
`3. Did the Board prejudicially err in holding all ’876 patent claims obvious?
`INTRODUCTION
`The Board prejudicially erred in holding claims 1-36 unpatentable for at
`least three reasons. First, the Board held the original priority document—the ’558
`provisional application—lacked written description for the ’876 patent claims’
`“alkyl glycoside” limitation. By repeatedly misapplying incorporation-by-reference
`law, the Board failed to recognize express possession of listed alkyl glycosides in
`the specification. Moreover, the Board improperly required a preference for “alkyl
`glycosides” rather than simple possession. Second, the Board overlooked the
`“dodecyl maltoside” limitations in dependent claims 26-28 and 30-33, which have
`Case: 21-1038 Document: 16 Page: 11 Filed: 02/02/2021
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`literal support in the '558 provisional application, as Neurelis pointed out. Third,
`all claims were held obvious over at least one reference that was not prior art (but
`for the Board's errors deciding priority) and that—even if prior art—do not support
`an obviousness conclusion. These prejudicial errors warrant reversing the Board's
`judgment against Neurelis. A remand would not cure these defects, because the
`record does not support the grounds on which Aquestive Therapeutics, Inc.
`("Aquestive") petitioned; hence, Neurelis respectfully requests reversal of the
`Board's decision.
`STATEMENT OF THE CASE
`A. Technical Background
`The '876 patent discloses nasally administering benzodiazepine drugs.
`Benzodiazepine drugs can be used to treat epilepsy, one of the most common
`serious neurological disorders, affecting nearly 1% of Americans. Appx10914-
`10915. Epilepsy can create challenges for education, employment, social
`interaction, driving, and independent living. Id. Immediate cessation of epileptic
`seizures, which fast-acting medication provides, is essential to treating this
`potentially life-threatening condition. Id. Without treatment, morbidity and
`mortality increase significantly. Id.
`Treating epilepsy with benzodiazepine formulations intravenously was
`known by 2008, but medical professionals had to inject these products, greatly
`2 2
`literal support in the ’558 provisional application, as Neurelis pointed out. Third,
`all claims were held obvious over at least one reference that was not prior art (but
`for the Board’s errors deciding priority) and that—even if prior art—do not support
`an obviousness conclusion. These prejudicial errors warrant reversing the Board’s
`judgment against Neurelis. A remand would not cure these defects, because the
`record does not support the grounds on which Aquestive Therapeutics, Inc.
`(“Aquestive”) petitioned; hence, Neurelis respectfully requests reversal of the
`Board’s decision.
`STATEMENT OF THE CASE
`A. Technical Background
`The ’876 patent discloses nasally administering benzodiazepine drugs.
`Benzodiazepine drugs can be used to treat epilepsy, one of the most common
`serious neurological disorders, affecting nearly 1% of Americans. Appx10914-
`10915. Epilepsy can create challenges for education, employment, social
`interaction, driving, and independent living. Id. Immediate cessation of epileptic
`seizures, which fast-acting medication provides, is essential to treating this
`potentially life-threatening condition. Id. Without treatment, morbidity and
`mortality increase significantly. Id.
`Treating epilepsy with benzodiazepine formulations intravenously was
`known by 2008, but medical professionals had to inject these products, greatly
`Case: 21-1038 Document: 16 Page: 12 Filed: 02/02/2021
`
`
`
`
`
`
`
`limiting their use for epileptic patients outside a hospital or clinic setting.
`Appx10915-10916. A rectal gel (Diastat®) was also available, but again its use
`was limited to specific situations, and not conducive to administration in public. Id.
`Diastat® was approved in 1997 and remained the only FDA -approved
`benzodiazepine product on the market in 2008 (the time of invention) that non-
`medical professionals could use to treat epileptic seizures. Appx10918-10919.
`Indeed, it was the only such product until the FDA approved NAYZILAM® in
`2019 and Neurelis's nasal product early in 2020. Appx656, Appx10931. Hence, an
`enormous unmet need existed when Neurelis filed the '558 provisional application
`describing intranasal benzodiazepine formulations, as Dr. Daniel Wermeling,
`Aquestive's replacement expert, reported before this litigation began. Appx00656-
`00659, Appx10639.
`The '876 patent claims all relate to methods of treating a patient by nasally
`administering a benzodiazepine solution. Claim 1 is the sole independent claim and
`recites (indenting added):
`A method of treating a patient with a disorder which is
`treatable with a benzodiazepine drug, comprising:
`administering to one or more nasal mucosal membranes
`of a patient a pharmaceutical solution for nasal administration
`consisting of
`a benzodiazepine drug,
`one or more natural or synthetic tocopherols or
`tocotrienols, or any combinations thereof, in an amount from
`about 30% to about 95% (w/w);
`3 3
`limiting their use for epileptic patients outside a hospital or clinic setting.
`Appx10915-10916. A rectal gel (Diastat®) was also available, but again its use
`was limited to specific situations, and not conducive to administration in public. Id.
`Diastat® was approved in 1997 and remained the only FDA-approved
`benzodiazepine product on the market in 2008 (the time of invention) that non-
`medical professionals could use to treat epileptic seizures. Appx10918-10919.
`Indeed, it was the only such product until the FDA approved NAYZILAM® in
`2019 and Neurelis’s nasal product early in 2020. Appx656, Appx10931. Hence, an
`enormous unmet need existed when Neurelis filed the ’558 provisional application
`describing intranasal benzodiazepine formulations, as Dr. Daniel Wermeling,
`Aquestive’s replacement expert, reported before this litigation began. Appx00656-
`00659, Appx10639.
`The ’876 patent claims all relate to methods of treating a patient by nasally
`administering a benzodiazepine solution. Claim 1 is the sole independent claim and
`recites (indenting added):
`A method of treating a patient with a disorder which is
`treatable with a benzodiazepine drug, comprising:
`administering to one or more nasal mucosal membranes
`of a patient a pharmaceutical solution for nasal administration
`consisting of
`a benzodiazepine drug,
`one or more natural or synthetic tocopherols or
`tocotrienols, or any combinations thereof, in an amount from
`about 30% to about 95% (w/w);
`Case: 21-1038 Document: 16 Page: 13 Filed: 02/02/2021
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`ethanol and benzyl alcohol in a combined amount from
`about 10% to about 70% (w/w); and
`an alkyl glycoside.
`The definition for the pharmaceutical solution uses the closed phrase "consisting
`of to limit the scope of both claim 1 and its dependent claims. Dependent
`claim 27 recites that "the solution consists of diazepam, vitamin E, ethanol, benzyl
`alcohol and dodecyl maltoside" (emphasis added). Dependent claims 26, 28, and
`30-33 also recite dodecyl maltoside. Dodecyl maltoside is an alkyl glycoside (see,
`e.g., '876 patent, col. 17, lines 5-8 and col. 35, lines 59-63).
`While benzodiazepine drugs are effective for immediate cessation of
`epileptic seizures, administering therapeutically efficacious