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`110094388.1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________________
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`PADAGIS US LLC,
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`Petitioner,
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`v.
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`NEURELIS, INC.,
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`Patent Owner.
`______________________________
`
`Case No. IPR2025-00464
`U.S. Patent No. 8,895,546
`______________________________
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`REPLY DECLARATION OF MAUREEN DONOVAN, PH.D. IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,895,546
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`Padagis US LLC, EX1078
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`110094388.1
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`TABLE OF CONTENTS
`I. Introduction ......................................................................................................................... 4
`II. Legal Standards ................................................................................................................... 5
`III. Level of Skill in the Art ...................................................................................................... 5
`IV. Summary of Opinions ......................................................................................................... 6
`V. The ‘558 Provisional Application Does Not Disclose Dodecyl Maltoside ........................ 7
`VI. The Claims of the ’546 Patent Would Have Been Obvious to a POSA ............................. 7
`VII. Conclusion and Reservation of Rights .............................................................................. 15
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`110094388.1
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`TABLE OF ABBREVIATIONS
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`Full Name of Cited Reference Abbreviation Exhibit No.
`U.S. Patent No. 8,895,546 ’546 patent 1001
`Provisional Patent Application No. 61/040,558 ’558 Provisional 1008
`PCT Patent App. Pub. No. WO 2009/120933 Gwozdz 1009
`U.S. Patent App. Pub. No. 2006/0046962 Meeza n 1010
`Final Written Decision issued in IPR 2019-00451 finding all
`claims of U.S. Patent No. 9,763,876 Unpatentable
`’876 Patent
`FWD 1040
`Declaration of Maureen Donovan, Ph.D. in Support of
`Petition for Inter Partes Review of U.S. Patent No.
`8,895,546
`Donovan Op.
`Decl. 1062
`U.S. Provisional Pat. App. No. 61/040,281 Gwozdz
`Provisional 1064
`U.S. Patent No. 9,763,876 ’876 patent 1071
`Expert Declaration of Professor Sveinbjorn Gizurarson in
`Support of Patent Owner’s Response to Petition for Inter
`Partes Review of U.S. Patent No. 9,763,876
`Gizurarson
`Decl. 1072
`Certified Transcript of Deposition of Marc Brown, Ph.D. in
`Padagis US LLC vs. Neurelis, Inc., IPR2025-00464,
`IPR2025-00465, IPR2025-00466 (March 17, 2026)
`Brown Dep. Tr. 1077
`Declaration of Mareen Donovan, Ph.D. in Support of
`Defendants’ Responsive Claim Construction Brief, Neurelis,
`Inc. v. Padagis LLC et al., 1:24-cv-562, D.I. 88-28 (D. Del.
`August 22, 2025)
`Donvoan Claim
`Construction
`Decl.
`2069
`Expert Declaration of Dr. Marc Brown Brown Decl. 2072
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`I. Introduction
`1. I, Maureen Donovan, have been retained by Padagis US LLC (“Padagis” or
`“Petitioner”) to provide my expert opinions regarding the petition for inter partes review (“IPR”)
`of U.S. Patent No. 8,895,546 (“the ’546 patent”) se t forth in the caption above. I previously
`submitted an expert declaration in this IPR on January 17, 2025 (“Donovan Op. Decl.”). See
`generally Ex. 1062.
`2. In my opening declaration, I opined that a ll claims of the ’546 patent would have
`been obvious to a person of ordinary skill in the art (“POSA”). Specifically, I opined that all claims
`of the ’546 patent are unpatentable as obvi ous over Gwozdz (Ex. 1009) in view of Meezan
`(Ex. 1010); See generally, e.g. , Ex. 1062 at ¶¶ 95-246. It is stil l my opinion that the challenged
`claims of the ’546 patent are unpatentable as obvious over Gwozdz in view of Meezan, and for the
`reasons discussed in my opening de claration. I incorporate by refe rence my opinions set forth in
`my declaration signed on January 17, 2025, submitted in this proceeding as Ex. 1062.
`3. In this reply declaration, I have been asked to reply to certain opinions set forth in
`the Expert Declaration of Dr. Marc Brown (Ex. 2072) submitted in support of Neurelis’s response
`to Padagis’s petition, as well as Neurelis’s Res ponse to Padagis’s IPR. To the extent I do not
`expressly address any opinions or points raised by Dr. Brown or Neurelis , that does not mean I
`agree with or otherwise concede those points. Rather, I focus my opinions in this reply declaration
`on specific topics but otherwise maintain my opinion that all claims of the ’546 patent are
`unpatentable as obvious for the reasons discussed in my opening declaration.
`4. My qualifications, list of testimony, and compensation were provided in my
`opening declaration and my curriculum vitae . See, e.g. , Ex. 1062 at ¶¶ 5, 7-16, Appendix A.
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`Further, the scope of my work and compensation remains the same since my opening declaration
`was submitted. My compensation does not depend on the outcome of this or any other proceeding.
`II. Legal Standards
`5. In my opening declaration, I discussed my understanding of various legal standards
`and principles relevant to my opinions, which I incorporate by reference in this reply declaration.
`See, e.g., Ex. 1062 at ¶¶ 23-36.
`III. Level of Skill in the Art
`6. In my opening declaration, I discussed my understanding and definition of a POSA
`with respect to the ’546 patent, which I incorporate by reference in this reply declaration. See, e.g.,
`Ex. 1062 at ¶¶ 17-22. Specifically, I opined that a POSA with respect to the ’546 patent should be
`defined as follows:
`[A] POSA would have been a pharmaceuti cal scientist, chemist, or biologist
`involved in the research a nd development of pharmaceuti cal formulations and/or
`delivery, and would have at least a Bachelor’s degree wi th at least 5 years of
`experience, or a Master’s, Ph.D. or Ph arm.D. degree with several years of
`experience. In addition, it is my opinion th at a POSA would have had knowledge
`of benzodiazepine structure and function, and would fu rther have knowledge and
`practical experience working with intran asal and transmembrane formulations,
`including knowledge of the physiology and anatomy of the nasal cavity, with
`relevant experience in developing intranasal formulations.
`Id. at ¶ 20.
`7. I also understand from Dr. Brown’s declara tion that Neurelis contends that the
`POSA should be defined as follows:
`[T]he skilled artisan holds a Master’s degree with many years of experience, or a
`Ph.D. or Pharm.D degree with several y ears of experience or its equivalent
`experience in the field of pharmaceutical research and development. The skilled
`artisan would have knowledge of benzodiazepine structure and function, including
`physiochemical characteristics of benz odiazepines generally. The skilled artisan
`would further have knowledge and pract ical experience developing and working
`with intranasal formulations, including knowledge of the physiology and anatomy
`of the nasal cavity and methods of adminis tering drugs intranasally. The skilled
`artisan also would have know ledge concerning clinical as pects of bioavailability,
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`tolerability, and patient acceptability of intr anasal formulations and the difficulty
`of administering drugs by other routes during an event like a seizure.
`See, e.g., Ex. 2072 (Brown Decl.) at ¶ 61.1
`8. While I disagree with Neurelis’s POSA definition, and maintain that a POSA
`should meet the definition described in my opening declaration, I qualified as a POSA as of 2008
`and am still a POSA today. The opinions in my opening declaration and this reply declaration are
`the same regardless of which POSA definition is ultimately adopted.
`IV. Summary of Opinions
`9. In forming the opinions set fo rth in this reply declarati on, I considered and relied
`upon the materials cited in my opening declaration, the materials cited in Dr. Brown’s declaration,
`and the materials cited in this reply declaration, including the materials identified in Appendix A
`to this declaration. My opinions and conclusions are also based on my education, experience, and
`knowledge of the relevant art.
`10. Further, in my opening declaration, I opined that all claims of the ’546 patent are
`unpatentable as obvious. Id. However, I was informed by counsel that after my opening declaration
`was submitted, Neurelis statutorily disclaimed all claims of the ’546 patent except claims 17 and
`22. I understand Dr. Brown has the same understanding. See, e.g., Ex. 2072 at ¶ 29. Thus, in this
`reply declaration, I address claims 17 and 22 of the ’546 patent (“the challenged claims”), which
`I understand are the only remaining claims of the ’ 546 patent. Further, as di scussed herein, it is
`my opinion that the ’558 provisional does not disclose or support “dodecyl maltoside;” the
`challenged claims would have been obvious to a POSA, as Dr. Brown’s arguments simply restate
`
`1 I note that while Dr. Brown discusses both proposed POSA definitions, he apparently takes no
`position about which POSA definition is correct or should be adopted in this proceeding.
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`previously unsuccessful positions, and M eezan clearly motivated a POSA to use
`n-dodecyl-β-D-maltoside with a reas onable expectation of succes s; and the antimicrobial
`properties of ethanol and benzyl alcohol would not be materially impacted by nonionic surfactants
`in a nasal spray formulation.
`V. The ‘558 Provisional Application Does Not Disclose Dodecyl Maltoside
`11. As explained in my opening declaration, it is my opinion that the claims of the ’546
`patent should be limited to a priority date of no earlier than March 27, 2009 (the filing date of the
`’439 application). See, e.g., Ex. 1062 at ¶¶ 42-54. In addition, and as I explained in my opening
`declaration, it is my opinion that the ’558 provisional application to which the ’546 patent claims
`priority does not mention or disclose alkyl glycosides generally or dodecyl maltoside specifically.
`Id.
`12. I have reviewed Dr. Brown’s declaration and understand he did not opine that the
`claimed “dodecyl maltoside” is supported by the ’558 provisional application, and thus he appears
`to agree that the priority date of the ’546 patent is March 28, 2009. See generally Ex. 2072. Indeed,
`at his deposition, Dr. Brown conf irmed that he has not offered any opinions about whether the
`claims of the ’546 patent should be entitled to an earlier priority date, including the filing date of
`the ’558 provisional application (i.e., March 28, 2008). See, e.g., Ex. 1077 at 46:14-50:16.
`13. Accordingly, for the reasons discussed in my opening declaration and by the PTAB
`in the ’876 patent final written decision, which Dr. Brown does not dispute, it is my opinion that
`the ’558 provisional application does not support or disclose the claimed formulations containing
`“dodecyl maltoside.” See, e.g., Ex. 1062 at ¶¶ 42-54.
`VI. The Claims of the ’546 Patent Would Have Been Obvious to a POSA
`14. I have reviewed Dr. Brown’s declaration and understand he opines that the claims
`of the ’546 patent would not have been obvio us to a POSA. While my original declaration
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`submitted in this IPR (Ex. 1062) addresses these arguments, there are a few specific issues below
`where I have provided additional discussion.
`15. Dr. Brown opines about whether the claims of the ’546 patent may contain water,
`including residual water associated with excipients like ethanol. See, e.g., Ex. 2072 at ¶¶ 124-126,
`133-139. Specifically, Dr. Brown points to a declaration I submitted in the district court proceeding
`involving the ’546 patent and opines that my “opini ons in the district cour t litigation . . . would
`seek to exclude even trace amounts of water from the scope of the claims.” Id. at ¶ 124-126.
`16. While I disagree with Dr. Brown’s characterization of my opinions from the district
`court claim construction declaration, I understand from c ounsel that Padagis has agreed to adopt
`Neurelis’s proposed construction in the district court proceedi ng, and has withdrawn all claim
`construction briefing and my supporting declaration. In other words, I understand that the parties
`have now agreed in both the district court and this IPR proceeding that the phrase “consisting of”
`does not require an express construction.
`17. As made clear in my orig inal declaration, the obvious ness analysis I provided
`applies the understanding that “consisting of” requires the claimed solution to “contain[] only” the
`claimed diazepam, vitamin E, ethanol, benzyl alcohol and dodecyl maltoside. See, e.g., Ex. 1062
`(Donovan Op. Decl.) at ¶ 138. Nowhere in the anal ysis of my original declaration or this
`supplemental declaration have I opined that “consisting of” requires the exclusion of trace amounts
`of water.
`18. Dr. Brown opines that neither Gwozdz nor Meezan disclosed or would have
`motivated a POSA to use dodecyl maltoside. See, e.g., Ex. 2072 at ¶¶ 178-199. For the reasons
`discussed in my opening declaration and below, I disagree with Dr. Brown.
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`19. As a threshold issue, I note that Dr. Brown points out that the Gwozdz provisional
`application does not include the phrase “penetration enhancers,” and he argues that this cuts against
`the motivation to combine Gwozdz and Meezan. See, e.g. , Ex. 2072 at ¶ 156. However, as
`established in my original de claration, there are numerous othe r rationales supporting a POSA’s
`motivation to combine that are unrelated to Gwo zdz’s disclosure of “penetration enhancer.” See
`Ex. 1062 (Donovan Op. Decl.) at ¶¶ 95-100, 104-110.
`20. Additionally, the passage from Gwozdz that I relied on states that other
`“pharmaceutically acceptable additives” maybe a dded to the Gwozdz formulations, including
`“acidifying, alkalizing, buffering, chelating, complexing and solubilizing agents, antioxidants and
`antimicrobial preservatives, pe netration enhancers, humectants , suspending and/or viscosity
`modifying agents, tonicity and wetting or other biocompatible materials’ to improve the efficacy.”
`Ex. 1062 (Donovan Op. Decl.) at ¶ 98 (emphasis added) (quoting Ex. 1009 (Gwozdz) at 10:12-16).
`While Dr. Brown and Neurelis assert that the “penetration enhancer” term is not supported by the
`Gwozdz Provisional, the “wetting…material” term is explicitly recited in the text of the Gwozd-
`Provisional. Ex. 1009 (Gwozdz) at 10:12-16. Add itionally, Meezan states that the absorption
`enhancers described therein are surfactants, and that “[t]he term “surfactant” is any surface active
`agent that modifies interfacial tension of water…Broadly, the group includes soaps, detergents,
`emulsifiers, dispersing and wetting agents, and several groups of antiseptics.” Ex. 1010 (Meezan)
`at ¶ [0053] (emphasis added). In my opinion a POSA would have viewed Gwozdz’s disclosure of
`the inclusion of a “pharmaceu tically acceptable additive,” incl uding a “wetting material” as
`supporting the motivation to combine the teachings of Gwozdz and Meezan, as laid out in my
`original declaration. Ex. 1062 (Donovan Op. Decl.) at ¶ 98.
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`21. Further, Dr. Brown’s own prior art public ations demonstrate that a POSA would
`have understood that the use of pe netration enhancers was beneficial in intranasal formulations.
`For example, Dr. Brown was listed as an aut hor on a textbook chapter published in 2007 titled
`“Physiological Factors Affecting Nasal Drug De livery.” Ex. 1073. In his 2007 textbook chapter,
`Dr. Brown contradicted many of the opinions he has expressed in his declaration in this IPR. For
`example, Dr. Brown’s 2007 text book repeatedly emphasizes w hy a POSA would have been
`motivated to develop an intranasal formulatio n of lipophilic small molecule drug compounds
`(which would include diazepam) with a reasonable expectation of success. See, e.g., Ex. 1073 at
`18 (“More recently, drugs with systemic action s have been marketed for nasal delivery in
`preference to oral delivery or injection. This takes advantage of the potentially rapid and high
`systemic availability of nasally administer ed compounds”); 23 (“Lipoph ilic drug molecules are
`absorbed across the nasal epithelium by passive transcellular diffusion. For small, unionized
`molecules, this provides a rapid efficient tr ansport mechanism, often resulting in plasma
`concentration profiles resembling that of intravenous injection and bioavailabilities of up to
`100%”); 32 (“The nasal route is generating increasing interest as a route for the administration of
`local treatments and a cost-effect ive and patient-friendly alternat ive to injection for systemic
`delivery. The special advantages of nasal delivery make it attractive for (i) crisis treatment where
`rapid onset of action is desirable”).
`22. And, Dr. Brown’s 2007 textbook dedicated a subsection of these formulation
`approaches to discussing the use of absorption enhancers . Id. at 27. Thus, in my opinion,
`Dr. Brown’s own prior art textbook, which specifically discusses nasal formulations and delivery
`of drugs, further supports my opinion that a POSA would have been motivated to use penetration
`enhancers in nasal formulations.
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`23. Further, Dr. Brown opines that even if a skilled artisan would have considered
`Meezan, there would have been no reason to modify Gwozdz to add alkyl glycosides, including
`dodecyl maltoside. Ex. 2071 (Brown Decl.) at ¶ 160. I disagree wi th Dr. Brown for a number of
`reasons, as explained below. Indeed, as I explained in my opening declaration, Meezan expressly
`discloses dodecyl maltoside as a preferred penetration enhancer. See, e.g., Ex. 1062 (Donovan Op.
`Decl.) at ¶ 91.
`24. Dr. Brown opines that “Meezan recommends using ‘highly branched’ alkyl
`glycosides” rather than linear alkyl glycosides. See, e.g., Ex. 2072 at ¶ 180; see also, e.g. , id. at
`¶¶ 191, 196, 198; see also Brown Dep. Tr. at 174:8-17. As explai ned in my parallel declarations
`addressing the ’414 and ’786 patents, Dr. Brown’s opinions on this issue seemed to be focused on
`those patents’ recita tion of “n-dodecyl- β-D-maltoside,” as opposed to “dodecyl maltoside” as
`claimed in the ’546 patent. Thus , it’s unclear to me how or why Dr. Brown even believes the
`chemistry and nomenclature issues he addresses in his ’414 and ’786 patent declarations are even
`relevant to the “dodecyl maltoside” limitation recited in the ’546 patent claims, particularly where
`he opines that “dodecyl maltoside” encompasses a genus of compounds, and because there is no
`question that Meezan discloses “dodecyl maltoside.”
`2 Indeed, I understand the PTAB previously
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`2 Because the chemistry and nomenclature issues ra ised by Dr. Brown are irrelevant to the ’546
`patent, I do not include a techni cal discussion or analysis of t hose issues in this declaration.
`However, I refer and incorporate by reference those discussions, set forth in my reply declarations
`in the ’414 and ’786 patent IPRs here, to the extent they are somehow relevant or germane to the
`issues in the ’546 patent IPR.
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`found the “dodecyl maltoside” limitation in the claims of the ’876 patent unpatentable as obvious
`over Gwozdz in view Meezan. Ex. 1040 at 33-36.
`25. In any case, Dr. Brown specifically cites to paragraph 149 of Meezan, which reads:
`Stability of the alkyl glycoside depends, in part, on the number of carbon atoms, or
`branching of the alkyl chain, with tetradec ylmaltoside (TDM) having the greatest
`effect; but other highly branched alkyl chains including DDM also have stabilizing
`effects. In contrast to Hovgaard-1, which described the preference for a high alkyl
`glycoside to drug ratio, the instant inventi on shows that this ratio is much lower.
`For example, alkyl glycosides in the range of about 0.01% to about 6% by weight
`result in good stabilization of the drug; whereas Hovgaard-1 shows stabilization is
`only achieved at much higher ratios of al kyl glycosides to drug (10:1 and 16: 1).
`Even more interesting, alkyl glycosides of the invention in the range of about 0.01%
`to about 6% have increased bioavailability (see FIG. 1). This is in sharp contrast to
`Hovgaard-2, which showed relatively low bioavailability (0.5-1%) at the high alkyl
`glycoside ratios (10:1 and 16:1).
`Ex. 1010 (Meezan) at ¶ [0149] (emphasis added).
`26. However, I understand Dr. Brown was relying on an uncorrected version of the
`Meezan specification. In fact, during prosecu tion, I understand Meezan’s specification was
`amended to delete the terms “branched” and “highly branched” and to replace those terms with
`“length” and “long,” respectively:
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`Ex. 1075 (Meezan Specification Amendment) at 6. Thus, in my opinion, Dr. Brown’s repeated
`reliance on the incorrect “highly branched” language from Meezan underscores that his opinions
`on this issue are incorrect. Rather, the correct Meezan specification emphasizes and supports my
`opinions: a POSA would understand that Meezan discloses alkyl glycosides having straight-chain
`(i.e., “long”) alkyl groups, not branched structures. Indeed, the corrected language above
`specifically emphasizes that “DDM” has a “long alkyl chain[].” Id.
`27. Finally, I understand Dr. Brown opines that Meezan disclosed that TDM, not DDM,
`was the “most preferred” and best performing alkyl maltoside, and therefore a POSA would have
`been motivated to use TDM rather than DDM. See, e.g., Ex. 2072 at ¶¶ 181-186. I understand from
`counsel that just because TDM purportedly outperformed DDM in Meezan’s disclosure, that does
`not mean DDM would not have been obvious. Rather, I understand that where a prior art reference
`discloses several options in the form of preferred or non-preferred embodiments, they may all be
`considered obvious. Thus, I disagree with Dr. Br own’s attempt to heighten the requirement for
`obviousness by arguing that a POSA woul d only ever consider or pursue the best performing
`ingredient.
`28. In any case, as explained in my openi ng declaration, Meezan expressly disclosed
`dodecyl maltoside as a “preferred” alkyl glycoside and reported that it was effective at increasing
`the permeability of drugs. See, e.g., Ex. 1010 at ¶¶ [0150]-[0151], [0157]-[0159], Table I. Thus,
`Meezan expressly disclosed that DDM was a preferred and effective absorption enhancer. The fact
`that TDM may have been more effective than DDM does not mean that DDM would not have been
`an obvious penetration enhancer to choose. Ind eed, Meezan shows that it would have been an
`excellent choice. In particular, Exam ple 3 of Meezan reported that dodecyl- β-D-maltoside
`concentrations of 0.25%, 0.375%, and 0.5% all ach ieved a dramatic impr ovement in absorption
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`and efficacy (as evidenced by the decreased blood glucose concentrations reported in Table I).
`EX1010 (Meezan) ¶[0158]. Although Dr. Brown relies heavily on his argument that Meezan did
`not demonstrate that a concentration of 0.125% dodecyl-β-D-maltoside was effective, this would
`not have discouraged a POSA from using dodecyl-β-D-maltoside in the greater concentrations that
`did show a significant improvement in absorption and efficacy. And, the challenged claims of the
`’546 patent would include concentrations of dodecyl- β-D-maltoside found to be effective in
`Meezan.
`29. Thus, I reiterate my opinion, that a PO SA would have been motivated by Meezan
`to use dodecyl maltoside as a penetration enhan cer for small molecules, like diazepam. And it
`remains my opinion that a POSA would have been motivated to combine Gwozdz and Meezan,
`and that they would have had a reasonable expectation of success.
`30. I understand that Neurelis and Dr. Brown have asserted that there would have been
`no motivation to combine Gwozdz and Meezan becau se the antimicrobial activity of the benzyl
`alcohol and ethanol components of Gwozdz might be reduced in the presence of a nonionic
`surfactant like dodecyl maltoside. POR 49-51; EX2074, ¶¶253-254. I disagree for several reasons.
`31. First, an intranasal formul ation (i.e., a nasal spray) as contemplated by Gwozdz
`would require a formulation in a final package that has virtually no bacteria present in the
`formulation. While the possibility of microbial contamination is alwa ys a consideration in
`pharmaceutical formulation development, for an emergency, one-time use product like a diazepam
`nasal spray, whether or not the antimicrobial properties of ethanol and benzyl alcohol are decreased
`or inactivated would not be seen as a limitation since single-use nasal spray devices able to deliver
`preservative-free nasal sprays were known in the art. These single-use devices would be also be
`suitable for the administration of diazepam in the emergency treatment of seizure.
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`32. However, even if a diazepam nasal spray formulation were inte nded to be used
`more than once, this would not impact the motivation to combine. A POSA would not expect that
`the very low concentrations of dodecyl-β-D-maltoside disclosed by Meezan (e.g., 0.25%, 0.375%,
`and 0.5%) would be sufficient to completely inactivate the antimicrobial properties of the
`relatively high concentrations of the combination of ethanol and be nzyl alcohol u tilized in the
`Gwozdz formulation.
`33. Thus, in my opinion, any potential imp act of the nonionic su rfactant (including
`dodecyl-β-D-maltoside) on the antimicr obial properties of ethanol and benzyl alcohol does not
`change my opinion that a motivation existed to combine Gwozdz and Meezan.
`VII. Conclusion and Reservation of Rights
`34. For the reasons set forth above and in my opening declaration, it is my opinion that
`the challenged claims (i.e., claims 17 and 22) of the ’546 patent are unpatentable as obvious.
`35. I reserve the right to supplement and/or expand on the opinions in this declaration
`based on any new positions Neurelis advances, a ny additional information that is produced or
`offered in this IPR, based on any relevant clai m construction, in response to any declarations
`submitted on behalf of Neurelis, or any other circumstances that impacts my opinions.
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`I declare that all statements made herein of my own knowledge are true and that all
`statements made on information and belief are believed to be true; and further that these statements
`were made with the knowledge that willful false statements and the like so made are punishable
`by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
`
`Dated: March 31, 2026 By:
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` Dr. Maureen Donovan
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`APPENDIX A: MATERIALS CONSIDERED
`
`Exhibit No. Description
`1001 U.S. Patent No. 8,895,546, Administration Of Benzodiazepine
`Compositions, filed June 13, 2012 (“’546 Patent”)
`1002
`File History for ’546 Patent, Ser. No. 13/495,942 (“’546 FH”) Part 1:
`Pages 1-350 Part 2: Pages 351-700 Part 3: Pages 701-1050 Part 4:
`Pages 1051-1400 Part 5: Pages 1401-1750 Part 6: Pages 1751-2100
`Part 7: Pages 2101-2450 Part 8: Pages 2451-2681
`1003 U.S. Patent No. 9,763,876, Administration Of Benzodiazepine
`Compositions, filed October 29, 2014 (“’876 Patent”)
`1004 File History for 9,763,876 Patent, Ser. No. 14/527,613 (“’876 FH”)
`Part 1: Pages 1-270 Part 2: Pages 271-530
`1005 Provisional Patent Application No. 61/497,017, filed June 14, 2011
`(“’017 Provisional”)
`1006 Provisional Patent Application No. 61/570,110, filed December 13,
`2011 (“’110 Provisional”)
`1007
`File History for Non-Provisional Patent Application Serial No.
`12/413,439, filed March 27, 2009 (“’439 FH”) Part 1: Pages 1-400
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