US 11793786

Summary: U.S. Patent No. 11,793,786 B2 (US11793786)

Important caveat on sources: I searched web sources (Google Patents, DrugPatentWatch, PTAB/Unified Patents portals, and litigation databases). The full claim text of US11793786 is not reproduced in the Google Patents page text supplied, and I was unable to retrieve a complete verbatim copy of every claim within my search step limit. The independent claims below are reconstructed from DrugPatentWatch and litigation/PTAB summaries that quote claim language; I flag the one area of genuine uncertainty (exact wording of independent claim 11).

Bibliographic data

• Title: Administration of benzodiazepine compositions
• Patent number / kind code: US 11,793,786 B2 (US11793786B2)
• Assignee: Neurelis, Inc. (listed as original and current assignee; sole owner per the company's press release; the patent is Orange Book–listed for VALTOCO®)
• Inventors: Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David F. Hale, Edward T. Maggio
• Application no.: US 17/228,514
• Filing date: April 12, 2021
• Priority date: March 28, 2008 (listed by Google Patents; some records show March 27, 2008)
• Issue date: October 24, 2023
• Status / expiration: Active; adjusted expiration listed by Google Patents as July 6, 2029; Orange Book/paragraph-IV sources list March 27, 2029
• Related proceedings: IPR2025-00466 (Padagis US LLC et al. v. Neurelis, Inc. — petition filed January 2025; trial instituted September 16, 2025); Delaware district court ANDA litigations (e.g., 1:24-cv-00562, 1:25-cv-00821, 1:26-cv-00261). I did not find a CAFC 2026 docket specifically naming the '786 patent in my searches (the Federal Circuit appeal 21-1038 found in the record concerns the related '876 patent IPR, not this patent).

Abstract

"The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions."

In plain terms, the patent covers a nasal (intranasal) diazepam drug product — the formulation science behind Neurelis's VALTOCO® diazepam nasal spray used to treat seizure clusters in epilepsy patients age 6+. The invention solves the problem that benzodiazepines like diazepam are poorly water-soluble and oral/IV/rectal routes are poorly suited to a seizing patient. The claimed solution uses a non-aqueous solvent system of vitamin E-type compounds (tocopherols/tocotrienols) plus alcohols (including benzyl alcohol) to keep diazepam dissolved at high concentration, together with the absorption enhancer n-dodecyl beta-D-maltoside (an Intravail® alkyl glycoside) to speed uptake across the nasal mucosa, achieving rapid onset while avoiding first-pass liver metabolism.

Independent claims — plain-language overview

The patent has two independent claims (claims 1 and 11) plus ~25 dependent claims; the complaint in the Delaware litigation asserts claims 1–3, 5–9, 11–13 and 15–27.

Independent claim 1 (verbatim text available from DrugPatentWatch): A pharmaceutical solution for nasal administration consisting of four recited components:

1. a therapeutically effective amount of diazepam (or a pharmaceutically acceptable salt);
2. one or more tocopherols or tocotrienols selected from α-, β-, γ-, δ-tocopherol, α-, β-, γ-, δ-tocotrienol, tocophersolan, their isomers/esters/combinations — totaling 30% to 95% (w/w) of the solution;
3. one or more alcohols totaling 10% to 70% (w/w), with the requirement that the alcohol component includes benzyl alcohol; and
4. n-dodecyl beta-D-maltoside (the alkyl-glycoside absorption enhancer).

Because the transition phrase is "consisting of," the formulation is closed: the nasal solution contains essentially only these ingredients (plus acceptable salt forms), no additional excipients, water, or other drugs.

Independent claim 11 (partial text available; exact wording not fully verified): A second independent claim to a pharmaceutical solution for nasal administration, again consisting of diazepam or a salt thereof, tocopherol(s)/tocotrienol(s) at 30%–95% (w/w), one or more alcohols at 10%–70% (w/w) including benzyl alcohol, and n-dodecyl beta-D-maltoside. Based on the dependent-claim structure and the parallel '414 patent in the same family, claim 11 appears to narrow the tocopherol/tocotrienol selection (e.g., toward α-tocopherol/"vitamin E"-type components) compared with the broader claim 1 list, but I could not confirm the precise narrowing language. Flagged uncertainty: treat the exact scope of claim 11's tocopherol limitation as unverified.

Representative dependent claims refine: diazepam concentration (e.g., 1–20% w/v; 10–250 mg/mL; 20–50 mg/mL); tocopherol amounts (45–85%, 60–75% w/w); alcohol amounts (15–55%, 25–40% w/w); the identity of the second alcohol (ethanol, propyl, butyl, pentanol, etc.); alkyl-glycoside amount (about 0.01–1% w/v; 0.125–0.5% w/v); and closed-form compositions such as "diazepam, vitamin E, benzyl alcohol, and n-dodecyl beta-D-maltoside" only.

Key sources

• Google Patents: https://patents.google.com/patent/US11793786/en
• DrugPatentWatch (claims text): https://www.drugpatentwatch.com/p/patent-claims/11793786
• Unified Patents litigation/IPR portal (IPR2025-00466; D. Del. cases): https://portal.unifiedpatents.com/ptab/case/IPR2025-00466
• PTAB Litigation Blog (institution/discretionary-denial coverage): https://www.ptablitigationblog.com/informative-no-discretionary-denial-where-prior-ipr-suggests-material-error-by-office/
• Neurelis press release (Nov. 27, 2023): https://www.biospace.com/neurelis-secures-new-orange-book-listed-u-s-patent-for-valtoco-diazepam-nasal-spray-civ

Bottom line

US11793786 is a formulation patent covering VALTOCO® (diazepam nasal spray) — specifically a closed, non-aqueous nasal solution of diazepam dissolved in tocopherol/tocotrienol (vitamin E-type) carrier with benzyl-alcohol-containing alcohols and the Intravail absorption enhancer n-dodecyl beta-D-maltoside. It is actively litigated (ANDA Paragraph IV cases and instituted IPR2025-00466 challenging validity on obviousness grounds over the Gwozdz PCT application and the Meezan alkyl-glycoside reference, including a priority-date dispute over the 2008 provisional application).

Based on my searches (which included Unified Patents-linked metadata on the Google Patents record for US 11,793,786, PACER-monitor/CourtListener/Justia dockets, DrugPatentWatch, and PTAB docket aggregators), here is what is publicly documented for US 11,793,786 B2 ("Administration of benzodiazepine compositions," assigned to Neurelis, Inc., covering VALTOCO® diazepam nasal spray). This is an Orange Book patent being enforced in Hatch-Waxman ANDA litigation and challenged in IPR.

District court (ANDA/Hatch-Waxman) cases

1. Neurelis, Inc. v. Padagis LLC et al. — D. Del. No. 1:25-cv-00821

• Plaintiff: Neurelis, Inc.
• Defendants: Padagis LLC; Padagis US LLC; Padagis Israel Pharmaceuticals Ltd.; Lupin Inc.; Lupin Ltd.; Lupin Pharmaceuticals, Inc.
• Jurisdiction: U.S. District Court for the District of Delaware
• Filed: July 2, 2025 (docket entry 1, per Justia/CourtListener)
• Patents in suit (per the case's patent report to the Commissioner): 11,241,414; 11,793,786; 12,268,664
• Subject: Generic versions of VALTOCO (diazepam nasal spray) under Padagis ANDA No. 219320 and Lupin ANDA No. 220394; '786 claims 1–3, 5–9, 11–13, and 15–27 asserted (per complaint analysis). Nature of suit: 35 U.S.C. § 271 (ANDA).
• Status: Open/pending; related VALTOCO ANDA cases have been consolidated (referenced as related to lead case C.A. No. 24-562 (MN) before Judge Maryellen Noreika).

2. Neurelis, Inc. v. Amneal Pharmaceuticals LLC et al. — D. Del. No. 1:26-cv-00261

• Plaintiff: Neurelis, Inc.
• Defendants: Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals, Inc.
• Jurisdiction: D. Delaware
• Filed: March 11, 2026 (complaint filed; summons issued same period)
• Subject: Amneal ANDA No. 219109 (generic VALTOCO, 7.5 mg and 10 mg diazepam nasal spray). This case is flagged on the Google Patents record for the '786 patent as litigation involving this patent; complaint analysis confirms assertion of related family patents (e.g., '414, '852, '061, '400).
• Status: Open; consolidated into lead case C.A. No. 24-562 (MN) per a Second Consolidation and Scheduling Order dated April 23, 2026 (bench trial set for January 2028 window before Judge Maryellen Noreika).

3. Neurelis, Inc. v. Strides Pharma Global PTE Limited et al. — D. Del. No. 1:26-cv-00947

• Plaintiff: Neurelis, Inc.
• Defendants: Strides Pharma Global PTE Limited; Strides Pharma, Inc.
• Jurisdiction: D. Delaware
• Filed: July 31, 2026 (assigned to Judge Maryellen Noreika)
• Patents in suit (per DrugPatentWatch and the case's patent report): 11,241,414; 11,793,786; 12,268,664; 12,324,852; 12,337,061; 12,521,400; 12,599,611
• Subject: Strides ANDA No. 221329 (diazepam nasal spray 5/7.5/10 mg per spray).
• Status: Open; related to/coordinated with the consolidated VALTOCO ANDA actions.

4–5. Related consolidated VALTOCO ANDA actions (referenced in the Strides complaint as related actions in the same D. Del. consolidation): Neurelis v. Lupin Inc. et al. (C.A. No. 1:26-cv-00258-MN) and Neurelis v. Padagis LLC (C.A. No. 1:26-cv-00401-MN). These are in the same family/consolidation; however, I could not independently confirm from the snippets that the '786 patent is asserted in each of these two specific dockets, so treat them as "related VALTOCO ANDA cases" rather than confirmed '786 cases.

PTAB / IPR proceeding

IPR2025-00466 — Padagis US LLC et al. v. Neurelis, Inc.

• Petitioners: Padagis US LLC (and affiliates), challenging the '786 patent (record exhibits include "786 Brown Declaration," redlines between the '786 and family patents, etc.)
• Status: Filed/petitioned early 2025; Patent Owner Preliminary Response filed June 17, 2025; institution decision issued ~July 16, 2025 (with a Director-discretion referral noted); PTAB docket aggregators (GreyB) list the proceeding as "Trial Instituted" as of the latest updates. The Google Patents record itself flags IPR2025-00466 as "Pending - Instituted." Case is active with a scheduling order (Sept. 17, 2025) and later filings through December 2025 (e.g., Patent Owner motion regarding certificate of correction).
• This is the IPR that the '786 patent record expressly flags.

Context (family litigation, not the '786 patent itself)

• An earlier family patent, US 9,763,876, was challenged by Aquestive (IPR2019-00451 et al.), found unpatentable by the PTAB on Aug. 6, 2020, with the Federal Circuit affirming on Oct. 7, 2021. That does not involve the '786 patent.
• A separate non-patent APA/regulatory suit (Neurelis v. Califf/FDA, D.D.C., filed May 2024) concerns VALTOCO orphan-drug exclusivity and Aquestive's Libervant approval; it does not assert the '786 patent.
• A California state tort suit (Neurelis v. Aquestive, San Diego Superior Court, filed Dec. 5, 2019) was settled out of court in December 2025; not a '786 patent-infringement case.

Important caveats

• Date discrepancy: You stated today's date as April 26, 2026, but several search results (CourtListener, PACER Monitor, DrugPatentWatch) contain docket entries dated through August 2026 (e.g., the Strides case filed July 31, 2026). Per your operating rules I have treated the live search results as ground truth and reported them, but you should confirm the actual current date and re-check PACER before relying on any "filed after today" entries.
• Outcomes: None of the '786 cases identified above shows a final judgment, settlement, or termination in the records I retrieved; all appear open/pending. For definitive current status (e.g., claim-construction rulings, trial dates, any settlements), PACER (D. Del. cases) and the PTAB's PRPS system (IPR2025-00466) would be the authoritative sources.

Proceedings overview

One active AIA trial proceeding is on file: IPR2025-00466 (Padagis US LLC v. Neurelis, Inc.), which the PTAB instituted on 2025-09-16/17 and which is still pending — no Final Written Decision has issued, no claim has been canceled or sustained on the merits, and there have been no settlements or institution denials.

A caution on the source data: the USPTO ODP snapshot provided in this prompt reports "no AIA trial proceedings," but that ingest is stale. Web search (and the Google Patents litigation metadata embedded in the patent text itself) confirms IPR2025-00466 against US 11,793,786 — filed 2025-01-17, trial instituted September 2025, projected FWD due date 2026-09-17 (eight days from today's date of 2026-09-09). Treat the ODP "zero" as a lag artifact, not as ground truth. No other IPR/PGR/CBM against the '786 patent surfaced in any source.

Bottom-line defensive posture: this patent has not been through a single completed IPR — it is mid-flight in its first one, with a decision due within days. A defendant cannot yet point to any canceled claim of the '786 patent, but the proceeding is unusually threatening to Neurelis because it re-runs the exact Gwozdz + Meezan obviousness combination that already killed the nearly identical claims of family member US 9,763,876 in IPR2019-00451 (affirmed, Fed. Cir. No. 21-1038).

IPR2025-00466 — Padagis US LLC v. Neurelis, Inc. (Patent 11,793,786 B2)

• Type: Inter Partes Review
• Filed: 2025-01-17 (petition docketed; notice of filing date accorded 2025-02-19)
• Status: Trial Instituted / Active — web-surfaced status ("Pending – Instituted" on Google Patents metadata; "Trial Instituted" in PTAB tracking databases). Plain English: the Board found Padagis's challenge sufficient to review; briefing and discovery are complete or nearly so, and a Final Written Decision is due on or before 2026-09-17. No FWD has issued as of 2026-09-09.
• Judge panel: APJ names are not stated in the public sources retrieved (the docket entries I located — the 2026-03-09 conduct order and 2026-03-20 rehearing decision in the lead case IPR2025-00464 — do not name the panel in the available text). Confirm on the USPTO PTAB E2E docket before citing panel composition.
• Petition grounds: Obviousness under 35 U.S.C. § 103 over Gwozdz PCT (EX1009) in view of Meezan (EX1010) — with additional secondary references (e.g., Cartt-'784 appears in the estoppel discussion) and three grounds (identified as "Grounds 1–3" in Patent Owner's response). Every ground is Gwozdz-dependent: the Board later observed that "none of Petitioner's grounds here across the three proceedings survives if Gwozdz is eliminated from consideration." The challenged claims are the VALTOCO® diazepam-nasal-solution composition claims (reciting n-dodecyl β-D-maltoside and "consisting of" language). I could not confirm the exact instituted claim-number list from public sources — pull the Institution Decision (Paper 13/14) from PTAB E2E before relying on a specific claim set.
• The dispositive threshold fight — priority date: Padagis's theory is that the '786 claims are not entitled to the 2008-03-28 priority date (Provisional 61/040,558), which would make Gwozdz PCT (published from the March 2009 family filings) available prior art. That mirrors IPR2019-00451, where the Board held nearly identical claims of related US 9,763,876 unentitled to the same provisional's date and invalid over Gwozdz + Meezan — affirmed by the Federal Circuit in the appeal docketed as No. 21-1038.
• Institution decision: Granted (trial instituted ~2025-09-16; Scheduling Order 2025-09-17). On referral from the Acting Director, the Board "determined that the allegedly narrowed claims of the '414 and '786 patents did not find adequate written description support in the relevant priority applications or avoid Gwozdz as prior art" (language quoted in the 2026-03-20 rehearing decision). In other words, the Board rejected Neurelis's priority/antedating defense at institution — a strong signal the Gwozdz-based grounds are viable on the merits.
• Discretionary-denial detour (informative decision): Neurelis asked Acting Director Coke Morgan Stewart to deny institution under Fintiv, pointing to a district court trial set for 2026-02-09 — months before the projected FWD of 2026-09-17. On 2025-07-16 the Acting Director denied discretionary denial and referred the petitions to the Board, reasoning that the examiner's later priority-date finding "directly contradicts" the Board's IPR2019-00451 determination and "raises concerns of material error" (Advanced Bionics), that the '414/'786 patents were recently issued (2022/2023), and that the three related petitions (IPR2025-00464/465/466) could be handled efficiently together. On 2026-01-09 Director John Squires designated that decision informative.
• Joint Research Agreement / § 103(c)(2) fight (procedural color): After institution, Neurelis moved for leave to file a petition for a certificate of correction to add a Joint Research Agreement disclosure — which would trigger the pre-AIA § 103(c)(2) safe harbor and knock Gwozdz out as prior art. The Board denied leave (order ~2026-02-06), citing Neurelis's seven-year delay (Gwozdz was first asserted in 2019 in the '451 IPR) and resulting unfair prejudice to Padagis, which is now time-barred from filing any non-Gwozdz challenge. The Board denied rehearing on 2026-03-20 and also denied (2026-03-20) reconsideration of a related certificate-of-correction ruling. The Board has additionally managed discovery disputes over Neurelis declarants Cartt, Mitchnick, and Hale (order 2026-03-09). These rulings keep Gwozdz live as the primary reference.
• Final Written Decision: Not yet issued (due 2026-09-17). All 27 claims of the '786 patent remain in force.
• Settlement / termination: None. The parties are actively litigating (expert depositions, conduct orders, reply briefing due 2026-03-24 per the rehearing decision).
• Appeal: None possible yet (no FWD). The Federal Circuit appeal in the related family proceeding — No. 21-1038, affirming the IPR2019-00451 unpatentability decision on US 9,763,876 — is highly relevant context and was cited by both sides here (Neurelis exhibits 2028–2029).
• Defensive value: Moderate-to-strong forward-looking value, zero current value. No claim of the '786 patent is dead today — an infringement theory built on any of claims 1–27 is fully intact. But Padagis has put the patent's core composition claims in genuine jeopardy: the identical Gwozdz + Meezan combination already invalidated near-identical claims of a family patent in a final, affirmed decision, and the Board has twice rejected Neurelis's procedural efforts to retire Gwozdz. If you are a defendant, the FWD landing on or before 2026-09-17 is the single most important near-term event in this patent's life.

Strategic summary

Claims status — CANCELED vs. SUSTAINED vs. UNTESTED. Nothing has been canceled and nothing has been sustained on the merits. All claims of US 11,793,786 are currently in force and untested by any completed AIA trial. The only proceeding, IPR2025-00466, was instituted in September 2025 and is awaiting its FWD (due 2026-09-17). The challenged claims are the VALTOCO diazepam nasal-solution composition claims that Padagis mapped to the IPR2019-00451 claim set; Neurelis's parallel Delaware complaint against the Padagis/Lupin ANDA products asserts claims 1–3, 5–9, 11–13, and 15–27 (claims 4, 10, and 14 — likely method claims — were not asserted in that complaint, per the complaint analysis), which is a good proxy for the commercial heart of the patent but not a verified statement of the IPR's instituted claim set.

Estoppel landscape. Because no FWD has issued, § 315(e)(2) estoppel has not yet attached to Padagis. Once the FWD issues, Padagis (and its privies) will be barred from asserting in district court or before the ITC any § 102/§ 103 ground it raised or reasonably could have raised during the IPR — which, given that all three of its grounds are Gwozdz-based, means Padagis is effectively riding a single-reference theory to its terminal outcome. Note the practical trap the Board itself flagged: Padagis is already time-barred (the 1-year § 315(b) clock ran from service of Neurelis's infringement complaint) from filing any new IPR that does not rely on Gwozdz — which is exactly why the Board found Neurelis's late JRA-correction gambit so prejudicial. For a different defendant (e.g., a Lupin or Strides-type ANDA filer not in privity with Padagis), no IPR estoppel applies at all: you remain free to run any § 102/§ 103 ground, including non-Gwozdz art, in district court, and you are not bound by the Board's priority-date or obviousness findings (though a final Padagis win would create powerful persuasive — and possibly collateral-estoppel-adjacent — pressure given the shared family and the affirmed '451 FWD).

Pattern signals. This is a coordinated, family-wide ANDA defense, not a one-off petition: Padagis filed three parallel IPRs on 2025-01-17 — IPR2025-00464 (US 8,895,546), IPR2025-00465 (US 11,241,414), and IPR2025-00466 (US 11,793,786) — all sharing the same Gwozdz + Meezan theory and the same priority-date linchpin, and all instituted. Neurelis is litigating hard on all fronts: it has parallel Hatch-Waxman cases in Delaware (e.g., 1:25-cv-00821 against Padagis, 1:26-cv-00261, 1:26-cv-00947 against Strides, plus the earlier 24-cv-00562), it sought Fintiv-based discretionary denial, and it has pursued post-institution certificate-of-correction relief to manufacture a § 103(c)(2) safe harbor — a strategy the Board characterized as years-late gamesmanship. Note also: the "Unified Patents" name on the Google Patents litigation metadata is only a data-licensing attribution, not a petitioner or defensive aggregator in the chain; the real petitioner is Padagis US LLC, a generic-drug competitor. The absence of any completed IPR on this patent, despite it being Orange Book-listed and heavily asserted since 2025, reflects the § 315(b) timing dynamics of Hatch-Waxman litigation more than any judgment on validity.

Recommended next steps

• If you are a defendant facing assertion of the '786 patent today: no claim has been invalidated, so an "IPR-killed-this-patent" defense is not available. Your best play is to monitor IPR2025-00466 for the FWD, which is statutorily due on or before 2026-09-17 — within days. Pull the decision from the USPTO PTAB E2E docket (case IPR2025-00466) the moment it drops; if the Board cancels the challenged composition claims, move immediately in the district court to dismiss or stay on the strength of the FWD, and cite the affirmed IPR2019-00451 result (Fed. Cir. No. 21-1038) as the family-wide backdrop. The Board's institution-stage rejection of Neurelis's priority defense, plus its refusal to let Neurelis add the JRA disclosure (orders of 2026-02-06 and 2026-03-20), makes a Padagis win on the merits a realistic outcome — but do not bank on it until the FWD actually issues.
• If you are Padagis or in privity: you are estopped from new, non-Gwozdz grounds once the FWD issues, and you are already time-barred from a second petition — your entire case is this proceeding. Verify the oral-hearing date and be prepared for a possible Neurelis appeal to the Federal Circuit if the FWD favors Padagis (expect the priority-date and § 103(c)(2) issues to be the appellate battleground).
• If you are a non-party ANDA filer (e.g., Lupin, Strides): you are not estopped. You may still develop independent § 102/§ 103 invalidity defenses using art other than the Gwozdz family publications, and you can separately attack the priority chain in district court — the PTAB's priority-date finding in IPR2025-00466 is not binding on you. If the FWD is adverse to Neurelis, consider whether collateral-estoppel or issue-preclusion arguments can be pressed given the near-identical claim scope and the common 61/040,558 provisional.
• Gap to close: confirm (a) the exact instituted claim numbers in the IPR2025-00466 Institution Decision, (b) the APJ panel composition, and (c) whether the scheduled 2026-02-09 Delaware trial actually proceeded and its outcome — none of which the retrieved public sources resolved. All dates and docket entries above are as surfaced on 2026-09-09; re-verify against PTAB E2E and the district court dockets before filing anything.

I'll research the assignment history for US Patent 11793786. Let me start with several searches.

This patent (US 11793786B2) is owned by Neurelis, Inc. and is an Orange Book-listed patent covering VALTOCO (diazepam nasal spray). Let me dig into the USPTO assignment records with specific reel/frame numbers and other details.

The PTAB record confirms Neurelis owns the family patent per reel 048271/0304. Let me dig deeper into specific assignment records and correspondent details.

I have reached the search limit, so I'll now synthesize the verified record. Note upfront what is and is not confirmed: I could not access the USPTO Assignment Center's correspondent field directly, and only one reel/frame number (048271/0304) is independently corroborated (via PTAB filings). All conveyance dates below come from Google Patents' legal-events table for US 11793786B2. I flag each unverified field rather than inventing it.

Ownership & NPE Analysis — US Patent 11793786B2

Inventors

All seven named inventors appear on the patent (application 17/228,514, filed 2021-04-12):

Pattern note: This is a 2008-origin invention family (priority 2008-03-28) developed by a tight San Diego group tied to Hale Biopharma Ventures, LLC and Aegis Therapeutics, LLC (Maggio/Hale/Loxley/Mitchnick are the Aegis/Hale principals; the Intravail® absorption-enhancer technology recited in the claims is Aegis' product). The inventors assigned to Hale Biopharma Ventures (recorded 2021-12-13), which then assigned to Neurelis — i.e., the inventors were never directly employed by the ultimate assignee, a common structure for a university/venture-development spin-out rather than a troll red flag.

Original assignee

• Original assignee / current owner of record: Neurelis, Inc. (San Diego, CA). The patent is solely owned by Neurelis per the Nov. 2023 Neurelis press release and is listed in the FDA Orange Book for VALTOCO® (diazepam nasal spray).
• Product: VALTOCO® — FDA-approved 2020 for acute treatment of seizure clusters in epilepsy patients ≥6 years. The '786 patent claims the VALTOCO formulation (diazepam + tocopherols + alcohols including benzyl alcohol + n-dodecyl β-D-maltoside). Yes — the owner ships a product embodying the claims.
• Line of business: Commercial-stage neuroscience/pharma company (private). It licenses the Intravail® transmucosal delivery technology from Aegis Therapeutics, which it incorporated into VALTOCO.
• Current status: Operating, commercially active, and litigating as a plaintiff in Hatch-Waxman ANDA cases (D. Del. 1:25-cv-00821 Neurelis v. Padagis LLC/Lupin; earlier "Padagis I" filed 2024-05-08).
• Prior owner in the recorded chain: Hale Biopharma Ventures, LLC — the venture-development entity that owned the family (see US 8,895,546 and US 9,763,876, both issued to Hale Biopharma Ventures) before transfer to Neurelis.

Assignment timeline

Recorded conveyances shown in the Google Patents legal-events table for US 11793786B2 (application 17/228,514). Caution: I could not independently verify reel/frame numbers or the correspondent-of-record for each entry from the USPTO Assignment Center within my search budget; the only reel/frame independently corroborated (via PTAB IPR2019-00449/-00450/-00451 mandatory notices) is the family transfer reel 048271 / frame 0304. No entries should be read as having verified correspondent data — I flag that as unknown rather than guessing.

• Executed / recorded ~2019-02 (reel 048271/0304, confirmed via PTAB mandatory notices in IPR2019-00449/-00450/-00451 for family patent US 9,763,876)
  • Conveyance: Assignment
  • Assignor: Hale Biopharma Ventures, LLC
  • Assignee: Neurelis, Inc.
  • Correspondent: not verified from my sources
  • Context: Transfer of the benzodiazepine-nasal-formulation family from the venture-development owner to the newly-formed commercial company (Neurelis) that would file the NDA and launch VALTOCO.
• 2021-08-06 (recorded) — the Google Patents event date
  • Conveyance: Security Agreement (security interest)
  • Assignor: Aegis Therapeutics, LLC and Neurelis, Inc.
  • Assignee: OrbiMed Royalty & Credit Opportunities III, LP
  • Correspondent: not verified from my sources
  • Context: Securitization / debt financing — OrbiMed (healthcare royalty-credit investor) took a collateral security interest in Neurelis' and Aegis' patent assets to back a credit facility; a financing event, not an ownership transfer. (Reel/frame not verified.)
• 2021-12-13 (recorded) — two same-day entries
  • Conveyance: Assignment of Assignor's Interest
  • Assignor: Cartt, Steve; Medeiros, David; Gwozdz, Garry Thomas; Loxley, Andrew; Mitchnick, Mark; Hale, David F.; Maggio, Edward T.
  • Assignee: Hale Biopharma Ventures, LLC
  • Correspondent: not verified from my sources
  • Context: Chain-of-title cleanup — inventors' assignment into Hale Biopharma Ventures recorded contemporaneously with the downstream transfer to Neurelis for the then-pending continuation application.
  • Conveyance: Assignment of Assignor's Interest
  • Assignor: Hale Biopharma Ventures, LLC
  • Assignee: Neurelis, Inc.
  • Correspondent: not verified from my sources
  • Context: Confirms Neurelis as owner of the '786 application; recorded the same day as the upstream inventors' assignment (internal reorg/title cleanup, not an arms-length sale).
• 2023-10-24 — Patent granted to Neurelis, Inc.
• 2024-11-14 (recorded) — the Google Patents event date
  • Conveyance: Release by Secured Party
  • Assignor: OrbiMed Royalty & Credit Opportunities III, LP
  • Assignee: Aegis Therapeutics, LLC; Neurelis, Inc.
  • Correspondent: not verified from my sources
  • Context: OrbiMed's security interest released — the loan was paid off / facility terminated (reel/frame not verified).

Bottom line on the record: No post-issuance sale to any third party. The chain is: inventors → Hale Biopharma Ventures LLC → Neurelis Inc. (2019 and 2021 recordings), plus a 2021 OrbiMed security interest released in 2024. Neurelis remains owner of record today.

Timeline diagram

timeline
    title Ownership of US 11793786
    2008 : Priority application filed
    2014 : Family patent issued to Hale Biopharma
    2017 : Family patent 9763876 issued
    2019 : Transferred Hale Biopharma to Neurelis
    2020 : FDA approves Valtoco nasal spray
    2021 : Continuation filed by Neurelis
         : OrbiMed security interest recorded
         : Inventor and Hale assignments recorded
    2023 : US 11793786 issued to Neurelis
    2024 : OrbiMed security interest released
    2025 : ANDA suits against Padagis and Lupin

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The intermediate owner, Hale Biopharma Ventures LLC, was a genuine venture-development vehicle whose patents (US 8,895,546; US 9,763,876) led directly to FDA-approved VALTOCO. The chain terminates at Neurelis, an operating company with a marketed product. The OrbiMed entry is a lender, not a shell.
2. Known asserter in the chain — Not present. No Acacia, Marathon, IV, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, or Unified/RPX-listed high-frequency plaintiff anywhere in the chain. The litigant, Neurelis, is a private commercial pharma company; its suits (1:25-cv-00821 and the 2024 Padagis I action) are Hatch-Waxman ANDA cases against generic filers.
3. Repeat correspondent across the chain — Unclear / not verifiable from my sources. The prosecution attorney of record on the family is DLA Piper LLP (US)/Pittsburgh (per the published applications). I could not retrieve the assignment-record correspondents, so I cannot confirm or exclude a recurring recording attorney. This is the one signal I could not fully test — do not treat as a finding.
4. Cascading transfers — Not present. Only three ownership links (inventors → Hale → Neurelis), with the 2021 entries recorded the same day as a title cleanup for a continuation. No chained LLCs with common registered agents, no rapid-fire portfolio shuffling.
5. Pre-litigation transfer — Not present. The ownership chain was completed by December 2021 (and the core family transfer in Feb 2019, reel 048271/0304); the first ANDA suit against Padagis came in May 2024, ~2.5 years later. The chain was not arranged to enable or venue the litigation.
6. Bankruptcy fire-sale — Not present. Neither Hale Biopharma Ventures nor Neurelis has been through a bankruptcy asset sale.
7. Privateering — Not present. Neurelis asserts its own Orange Book patent against generic ANDA entrants to defend VALTOCO's exclusivity — the textbook operating-company scenario. No evidence it is asserting on behalf of a hidden operating-company principal.
8. Defensive aggregator (anti-NPE) — Not present. Chain does not end at RPX/AST/LOT/Unified/OIN; it ends at the commercial owner.

Verdict

Operating-company assertion.

The patent is owned by Neurelis, Inc., a commercial-stage pharma company that markets the FDA-approved product VALTOCO® embodying the claimed diazepam nasal formulation; the ownership record is a straightforward inventors → Hale Biopharma Ventures → Neurelis chain (2019 family transfer at reel 048271/0304, confirmed in PTAB IPR2019-00449 notices; 2021-12-13 assignments) plus an OrbiMed security interest recorded 2021-08-06 and released 2024-11-14. Neurelis' only litigation (D. Del. 1:25-cv-00821, and the May 2024 Padagis I action) is routine Hatch-Waxman ANDA enforcement against generic challengers — exactly what an operating patent owner does — and the IPR2025-00466 petition by Padagis confirms the patent is being defended, not monetized, by Neurelis. None of the structural NPE signals (shell transfers, known asserter, cascades, pre-litigation transfers, privateering) are present; the lone untestable item is assignment-correspondent recurrence, which is not evidence of anything by itself.

Verification link: USPTO Patent Assignment Search — https://assignmentcenter.uspto.gov (search patent number 11793786); cross-checked against PTAB IPR2019-00449/-00450/-00451 mandatory notices (reel 048271/0304) and Google Patents legal events for US11793786B2.

Data caveats: I could not pull the USPTO Assignment Center correspondent-of-record fields or confirm reel/frame numbers for the 2021-08-06, 2021-12-13, and 2024-11-14 entries within my search budget. Those specific fields should be verified against the Assignment Center PDFs before this report is used for formal chain-of-title purposes.

Let me get the full list of cited references for the '786 patent from the Google Patents page.

I've gathered what's accessible, but I want to flag a data limitation up front before giving the analysis.

Data-availability caveat

I could not fully retrieve the as-granted USPTO front-page "References Cited" list for US 11,793,786 B2 during this session (search-step limit reached before the complete citation pane was returned). What I can verify with high confidence:

• Target patent: US 11,793,786 B2 — "Administration of benzodiazepine compositions"; application 17/228,514 filed 2021-04-12; published as US 2022/0062227 A1 (2022-03-03); granted 2023-10-24; assignee Neurelis, Inc.; inventors Cartt, Medeiros, Gwozdz, Loxley, Mitchnick, Hale, Maggio. Priority claimed to US 61/040,558 (2008-03-28) via US 12/413,439 (2009-03-27, abandoned) and US 15/955,397.
• The '786 is an Orange Book-listed patent covering VALTOCO® (diazepam nasal spray). Per the Neurelis announcement and the issue summary, its claims cover nasal pharmaceutical solutions of diazepam with (i) tocopherols/tocotrienols at ~30–95% w/w, (ii) an alcohol system at ~10–70% w/w including benzyl alcohol, and (iii) n-dodecyl β-D-maltoside.
• The patent is being challenged in IPR2025-00466 (instituted/pending) and is asserted in Delaware litigations (e.g., 1:25-cv-00821; 1:26-cv-00261).

Because the granted claim text and full examiner citation list were not available to me verbatim, my claim mapping below is based on the independent-claim elements as reported/publicly summarized, and should be treated as provisional.

The most relevant prior-art universe for the '786 patent

The '786 patent sits in a large Neurelis/Hale BioPharma/Aegis family. Its claims are directed to a dissolved diazepam solution in a tocopherol/tocotrienol + benzyl-alcohol-containing vehicle with dodecyl maltoside. The most relevant references therefore fall into three buckets: (A) same-family publications (relevant to priority, not true § 102 art if the 2008 priority date holds), (B) the alkyl-glycoside/Intravail art of Aegis/Maggio (the closest art on the "dodecyl maltoside" element), and (C) general intranasal-benzodiazepine and nanoparticulate art.

A. Same-family documents (primarily relevant to priority/§ 102 timing, not independently anticipatory if priority is valid)

B. The closest true third-party art — alkyl glycoside / Intravail (Aegis/Maggio)

These are the references that matter most for the n-dodecyl β-D-maltoside and intranasal benzodiazepine elements of the independent claims. Several have effective filing dates before the 2008-03-28 critical date and therefore can be § 102(a)(1)/(a)(2) prior art (pre-AIA).

C. General intranasal-benzodiazepine and particulate art (appears on the family's citation lists; relevant mainly to narrower/dependent claims)

From the IPR2025-00464 EX1001 exhibit reproducing the References Cited of parent US 8,895,546 B2, the examiner considered nanoparticulate and intranasal benzodiazepine art including (OCR names; numbers only partially legible in the search snippet): Liversidge et al. (US 2009/0304801 A1, nanoparticulate benzodiazepine compositions), Swanson et al. (US 2009/0297619 A1), Back et al. (US 2011/0172211 A1), Leane et al. (US 2010/0203119 A1), plus numerous WO publications (WO 94/05262, WO 95/00151, WO 97/14407, WO 98/30566, etc.). Because the '786's principal claims (as summarized) are directed to fully dissolved diazepam solutions, this particulate/suspension art is unlikely to anticipate the independent solution claims but could bear on dependent claims directed to microparticle/nanoparticle suspensions (which the specification still describes even though the granted claims appear focused on solutions).

Bottom-line assessment

• No single reference I can verify anticipates all elements of the summarized independent claims (diazepam + tocopherol/tocotrienol 30–95% w/w + alcohol(s) 10–70% w/w comprising benzyl alcohol + n-dodecyl β-D-maltoside, as a nasal solution) on the information available. The full anticipation question hinges on whether any pre-2008 document (most likely an Aegis/Intravail disclosure or an early family publication) discloses that exact four-component solution — and I could not confirm such a disclosure in this session.
• The most legally significant references are the Aegis/Maggio alkyl-glycoside disclosures (US 5,661,130; US 2006/0046962 A1; US 2009/0047347 A1 and its chain) for the dodecyl-maltoside element, and the same-family Cartt filings (US 2008/0279784 A1, US 2009/0130216 A1, US 2009/0258865 A1, US 8,895,546 B2) for the diazepam/tocopherol/alcohol vehicle element. No single one of those appears to read on all claim elements, which is why the live challenges (IPR2025-00466 on the '786; IPR2025-00464 on sibling US 8,895,546) are more likely to proceed on § 103 obviousness combinations than clean § 102 anticipation — though I could not retrieve the IPR grounds/petition references to confirm the specific asserted art.
• If you need the exact as-granted USPTO References Cited and verbatim claims of the '786, I recommend pulling the published patent PDF (PatFT/Patent Center) or the Google Patents "Citations" tab directly, since those were the two items I could not fully capture within the search limits.

Obviousness Analysis — U.S. Patent No. 11,793,786 B2 ("Administration of Benzodiazepine Compositions")

Preliminary notes on the record

A threshold caveat: the patent text you provided (Google Patents HTML for US11793786B2) contains the specification/definitions but not the granted claim set or the formal "Citations" (prior-art) listing, and my live searches could not pull the complete granted claims. The analysis below therefore reconstructs the claim scope from (a) the specification you supplied, (b) the parallel granted claims in the same family (notably the parent patent US 9,763,876, whose claim 1 is quoted in the public IPR record), and (c) the pending PTAB challenges. Where I am inferring claim language, I say so explicitly.

Public record confirms the following litigation context, which is directly relevant to any § 103 analysis of this patent:

• US11793786B2 (the "'786 patent"), assigned to Neurelis, Inc., covers Valtoco® (diazepam nasal spray). Priority is claimed back to a provisional filed March 28, 2008 (61/040,558) via the '439 application filed March 27, 2009 and later continuations (application 17/228,514 filed April 12, 2021). Orange Book expiration March 27, 2029.
• The related parent patent US 9,763,876 ('876) was challenged in IPR2019-00451; the PTAB found the challenged claims unpatentable under § 103 over Gwozdz + Meezan '962, and the Federal Circuit affirmed (21-1038).
• The '786 patent is now itself the subject of IPR2025-00466 (Padagis US LLC et al. v. Neurelis, Inc.), which was instituted (institution decision on/around September 16–17, 2025), along with sibling IPRs IPR2025-00464 (US 8,895,546) and IPR2025-00465 (US 11,241,414). The PTAB trial is scheduled for June 16, 2026, with final written decision projected by September 17, 2026. The petitioner's principal ground relies on "Gwozdz PCT" (EX1009) in view of secondary references such as Meezan, and the threshold fight is whether the challenged claims are entitled to the March 28, 2008 provisional priority date (which would remove Gwozdz PCT as § 102(e) prior art).

Sources: https://patents.google.com/patent/[US11793786](/patent/US11793786)/en; https://ipverse.greyb.com/ptab-web/cases/case-details/IPR2025-00466; https://paragraphfour.com/members/parryashford/activity/11704/; http://bannerwitcoff.com/wp-content/uploads/2020/08/PTAB-IPR2019-00451-44.pdf; https://www.drugpatentwatch.com/p/patent-claims/[9763876](/patent/9763876).

I. The claimed invention (as inferable from the record)

Based on the specification and the family claims, the '786 claims are directed to pharmaceutical compositions/solutions for nasal (intranasal) administration containing, in substance:

1. a benzodiazepine drug — in the granted claims, diazepam or a pharmaceutically acceptable salt thereof, in a therapeutically effective amount / defined concentration (e.g., about 1–20 mg per dose; about 20–50 mg/mL or up to about 250 mg/mL);
2. one or more natural or synthetic tocopherols or tocotrienols (α-, β-, γ-, δ-tocopherol; α-, β-, γ-, δ-tocotrienol; tocophersolan; isomers/esters/combinations) in an amount of about 30% to about 95% (w/w) (dependent claims narrow to 45–85%, 60–75%, about 70%);
3. one or more alcohols or glycols (ethanol, propyl/butyl/pentyl/benzyl alcohol; ethylene/propylene/butylene/pentylene glycols, excluding polymeric glycols) in an amount of about 5–70% (w/w), preferably 10–70% (dependent claims: 15–55%, 25–40%, about 30%); and per the granted-claim summaries in the public record, the alcohol system in the granted claims is constrained to include benzyl alcohol; and
4. n-dodecyl β-D-maltoside (DDM) — an alkyl glycoside absorption enhancer (Intravail®-type), in defined quantitative ranges (the specification discloses alkyl glycoside amounts of about 0.01–1% w/v, about 0.05–0.5% w/v).

The specification emphasizes fully dissolved (single-phase), substantially water-free solutions, and methods of treating seizures, with fast onset (<30 min, <15 min, <10 min, <5 min) and avoidance of first-pass metabolism. (US11793786B2; mtec-sc.org patent summary; IPR2019-00451 record.)

II. The § 103 legal framework

Obviousness under 35 U.S.C. § 103 is assessed from Graham v. John Deere (1966) and KSR Int'l v. Teleflex (2007): (1) scope and content of the prior art; (2) differences between the prior art and the claims; (3) the level of ordinary skill in the art; and (4) objective indicia. Under KSR, a patent claim is obvious when the prior art would have provided a person of ordinary skill in the art (POSITA) with a reason to combine known elements to achieve the claimed result with a reasonable expectation of success — the analysis is flexible and does not require an explicit teaching, suggestion, or motivation in the references. Overlapping ranges between a claim and a prior-art disclosure create a presumption of obviousness, rebuttable only by a showing of criticality/unexpected results or teaching away.

Level of skill: a formulation scientist (Ph.D./M.S.-level) with experience in intranasal and non-aqueous pharmaceutical formulation, solubility engineering, and mucosal drug delivery, and familiarity with benzodiazepine rescue therapy for seizures (per the expert declarations of Dr. Peppas, Dr. Wermeling, and Dr. Donovan in the IPR record).

III. The prior art of record

Because the Google Patents "citations" section was not included in your page text, the following are the references that the record (specification incorporations, the IPR2019-00451 final decision, and the IPR2025-00464/465/466 docket) identifies as the operative prior art:

1. "Gwozdz PCT" (EX1009 in IPR2025-00466) — the Gwozdz et al. PCT application (published counterpart US 2011/0038899 A1, "Pharmaceutical Solutions and Method for Solubilizing Therapeutic Agents"), filed March 27, 2009, claiming priority to the Gwozdz Provisional 61/040,281 filed March 28, 2008. This is the closest single reference. It discloses:

• nasal pharmaceutical solutions of benzodiazepines (including diazepam) in tocopherol/tocotrienol + alcohol/glycol carrier systems;
• tocopherol/tocotrienol in amounts of about 30–99% (w/w) (overlapping the claimed 30–95%) and alcohol/glycol in amounts of about 1–70% (w/w) (overlapping the claimed 5–70%/10–70%);
• alcohols expressly including ethanol, propyl alcohol, butyl alcohol, pentanol, and benzyl alcohol and combinations thereof;
• viscosity reduction of tocopherol by dilution with alcohol/glycol to produce sprayable formulations;
• express solubility data: "at 70% tocopherol:30% ethanol (200 proof), Diazepam is soluble to ≥ 8% and at 95% tocopherol:5% ethanol, Diazepam is soluble at ≥ 9%", with tocopherol:ethanol ratios of 95:5, 90:10, 85:15, 80:20, 75:25, 70:30, 65:35, and 60:40;
• administration to nasal mucosal membranes for treating seizures.

2. Meezan '962 (the alkyl glycoside / Intravail® reference relied on in IPR2019-00451; cited by petitioners as disclosing that alkyl glycosides, including dodecyl maltoside, "stabilize the biological activity and increase the bioavailability of the drug" for intranasal delivery). Meezan '962 discloses non-toxic, non-ionic alkyl glycosides as intranasal absorption enhancers.

3. US 5,661,130 — incorporated by reference in the '786 specification itself for the definition of alkyl glycosides (any sugar joined to a hydrophobic alkyl), i.e., DDM-type enhancers were already known before the priority date.

4. US 2009/0047347 A1 — published February 19, 2009 (before the earliest possible priority date of the challenged claims if priority to 2008 is not sustained for the full claim scope); cited in the '786 specification for Intravail® alkyl glycosides and their HLB characteristics.

5. US 6,193,985 (Sonne) — Vitamin E TPGS, incorporated by reference in the '786 specification (relevant to dependent/alternative embodiments involving synthetic tocopherols).

6. Commercial diazepam products — Diastat® (rectal gel) and injectable Valium® — which, per the credited expert testimony in IPR2019-00451, combined benzyl alcohol + ethanol + diazepam in co-solvent systems and provided a documented reason for a POSITA to include benzyl alcohol with ethanol in a diazepam co-solvent vehicle.

7. Cartt '784 / related Neurelis publications — disclosing intranasal benzodiazepine administration protocols (single nostril, both nostrils, sequential sprays) relied on for method-of-administration claim elements in the family.

IV. Combinations that would render the claims obvious

Combination A — Gwozdz PCT (EX1009) alone or with routine optimization (primary ground)

Claim elements met by Gwozdz PCT alone (for the base composition claims):

• Benzodiazepine drug dissolved in a non-aqueous tocopherol/alcohol vehicle — expressly disclosed (diazepam ≥8–9% w/w soluble in 70:30 and 95:5 tocopherol:ethanol).
• Tocopherol/tocotrienol 30–95% w/w — Gwozdz's 30–99% range overlaps the claimed range; under settled Federal Circuit law, an overlapping range creates a presumption of obviousness unless criticality is shown.
• Alcohol/glycol 5–70% (w/w), preferably 10–70% — Gwozdz discloses 1–70% with ethanol at 1–40% or 10–30%, and tocopherol:ethanol ratios from 60:40 to 95:5, all within or overlapping the claimed ranges.
• Benzyl alcohol — Gwozdz expressly lists benzyl alcohol as an alcohol usable in the carrier system; the combination of ethanol + benzyl alcohol in diazepam solutions was independently known from Diastat and Valium (credited Peppas/Wermeling testimony in IPR2019-00451).
• Sprayable nasal formulation — Gwozdz expressly motivates diluting tocopherol with alcohol/glycol to reduce viscosity for sprayability.

Gap: n-dodecyl β-D-maltoside (DDM). Gwozdz PCT, on the record as developed in IPR2025-00466, discloses absorption/penetration enhancers in general terms (in the PCT text added after the provisional) but the petitioners' specific DDM disclosure comes from Meezan '962 / US 2009/0047347 / US 5,661,130.

Combination B — Gwozdz PCT + Meezan '962 (DDM/alkyl glycoside) — the core obviousness combination

This is the combination that the PTAB credited in IPR2019-00451 against the materially identical family claims of the '876 patent (claims requiring tocopherol 30–95%, ethanol + benzyl alcohol 10–70%, and an alkyl glycoside), and it is the combination on which Padagis's instituted IPR2025-00466 ground is based.

Element-by-element mapping:

Motivation to combine (why a POSITA would do it):

1. Complementary problem-solving. Gwozdz solves the problem of poor drug solubility/precipitation in nasal diazepam delivery by engineering the solvent system; Meezan '962 solves the parallel problem of poor absorption/bioavailability by adding alkyl glycoside enhancers. The PTAB in IPR2019-00451 credited testimony that a POSITA "would seek to combine the teachings of the references in an effort to successfully increase the bioavailable amount of drug."
2. Same field, same goal. Both references address intranasal drug administration; a POSITA seeking a fast-onset, reliable rescue treatment for seizures would consult both solubility- and absorption-focused art.
3. Known, predictable enhancer class. Alkyl glycosides (DDM in particular) were a known, marketed enhancer technology (Intravail®) described as non-toxic and non-irritating at low concentrations (0.01–1% w/v), exactly the concentrations disclosed in the '786 specification.
4. Benefit of enhancers even at high intrinsic bioavailability. Credited testimony in IPR2019-00451 established that "a POSA would understand the benefits from using a penetration enhancer, even in situations of already-high bioavailability, as penetration enhancers would (among other things) be useful in adjusting the rate and amount of drug absorbed purely intranasally" — directly serving the '786 patent's stated goal of onset <5–15 minutes.
5. No teaching away. Gwozdz's specific 70:30 example is expressly a non-limiting example; a POSITA would recognize the ternary system option (tocopherol + ethanol + benzyl alcohol + enhancer) and would routinely adjust solvent ratios to preserve solubility, per the credited Wermeling/Peppas testimony.

Reasonable expectation of success: DDM is a small-molecule surfactant that partitions to the mucosal interface; its enhancer function does not depend on an aqueous bulk vehicle, and adding ≤1% w/v of a surfactant to a non-aqueous solution was a routine formulation exercise. The Board in IPR2019-00451 found petitioners had shown reasonable expectation of success in reaching even the bioavailability ranges recited in the '876 claims.

Combination C — Gwozdz PCT + US 2009/0047347 (Intravail®/HLB-selected alkyl glycosides) or + US 5,661,130

Even if Meezan '962 were set aside, the '786 specification itself identifies US 5,661,130 (incorporated by reference) and US 2009/0047347 as teaching alkyl glycoside enhancers — including DDM and tetradecyl maltoside — and the selection of DDM for nasal delivery was published before the relevant date (US 2009/0047347, February 19, 2009). A POSITA combining Gwozdz's diazepam/tocopherol/benzyl-alcohol solution with the DDM enhancer teachings of US 2009/0047347 or US 5,661,130 would arrive at the claimed composition with the same motivation and expectation of success as in Combination B. These references independently fill the DDM gap.

Combination D — add Cartt '784 / family publications for administration-limitation claims

To the extent any method claims require particular spray protocols (one nostril, both nostrils, sequential sprays, optionally with a time delay), Cartt '784 (2008) disclosed exactly these protocols, and the IPR2019-00451 Board found no deterrence to such dosing. Combining Gwozdz + Meezan with Cartt would render such method claims obvious.

V. The pivotal issue: priority date and availability of Gwozdz PCT as prior art

The single most important contested issue — and the reason the PTAB instituted IPR2025-00466 despite the family's 2008 provisional — is whether the '786 claims are entitled to the March 28, 2008 priority date (Provisional 61/040,558).

• In IPR2019-00451, the Board found the family's claims not entitled to the '558 provisional priority date because the later-added subject matter (notably the ethanol+benzyl alcohol combination and/or the alkyl glycoside/DDM limitation) was not supported by the provisional.
• During prosecution of the '414 and '786 patents, the examiner nevertheless accepted the 2008 priority date because the claims differed.
• The Acting Director (in declining discretionary denial and referring the petitions to the Board) found the examiner's position directly contradicted the Board's earlier determination and raised "concerns of material error," and the Board thereafter instituted trial.

The mechanics matter for § 103:

• Gwozdz PCT (EX1009) was filed March 27, 2009 and claims priority to the Gwozdz Provisional 61/040,281 filed March 28, 2008 — the same day as the '558 provisional.
• If the '786 claims are entitled to March 28, 2008, Gwozdz PCT (filed 2009) is not § 102(e) prior art (it has no earlier effective date).
• If the '786 claims are not entitled to the 2008 provisional (because, e.g., DDM/benzyl-alcohol subject matter was first added later), then their effective date is March 27, 2009 (the '439 application) or later — and Gwozdz PCT, with a 2008 effective date and 2010–2011 publication, is § 102(e) prior art for everything it discloses that is supported by its own 2008 provisional.
• Patent Owner's IPR papers argue that the specific "penetration enhancer" language in Gwozdz PCT on which Padagis relies for a motivation to add Meezan was not in the Gwozdz Provisional — i.e., that the motivation evidence is not itself prior art. The Board will have to resolve whether, absent that passage, the motivation to combine still exists on the remainder of Gwozdz PCT plus the general knowledge of a POSITA (e.g., the known value of DDM/Intravail enhancers from Meezan/US 2009/0047347, independent of Gwozdz's own text). Under KSR, the motivation inquiry is objective and may rest on the knowledge of a POSITA and the nature of the problem, not solely on a teaching in Gwozdz — so the absence of Gwozdz's "penetration enhancer" sentence is not necessarily fatal to the ground.

VI. Patent Owner's counterarguments and their likely strength

A complete § 103 analysis must weigh the rebuttal case, which in the IPR record includes:

1. No motivation to disturb a precipitation-sensitive, solubility-optimized formulation. Neurelis argues Gwozdz's formulations sit near diazepam saturation, so a POSITA would not reduce tocopherol/ethanol to add a surfactant. The Board in IPR2019-00451 rejected the same argument: disclosed examples/preferred embodiments are not teaching away, and a POSITA "would adjust the amounts of the three solvents to maximize solubility." This precedent likely carries over to the '786 claims.
2. Meezan '962 is aqueous/peptide-focused. Patent Owner argues alkyl glycosides were taught only as aqueous stabilizers and for water-soluble (peptide/protein) drugs. The IPR2019-00451 Board was "not persuaded," crediting testimony that enhancer function is not limited to aqueous vehicles or large molecules; however, Patent Owner's expert (Dr. Donovan) deposed December 2025 and new exhibits (e.g., Constantinides 2006, Rowe 2009, Rozman 2007, Kamal-Eldin) suggest a renewed attack on whether a POSITA would expect DDM to function in a non-aqueous tocopherol/benzyl-alcohol/ethanol vehicle.
3. Priority-date battle (see Section V). If Patent Owner wins on priority (claims entitled to March 28, 2008), Gwozdz PCT cannot be used at all, and the remaining art (e.g., Meezan alone; US 2009/0047347 of Feb. 19, 2009) would need to be combined with something disclosing the tocopherol/benzyl-alcohol diazepam solution — much harder without Gwozdz.
4. Objective indicia. Patent Owner has submitted FDA clinical-superiority findings for Valtoco (EX2001), secondary references on long-felt need/unmet need for out-of-hospital seizure rescue therapy (Cloyd 2021, Hogan 2020, Penovich 2017/2024, Rabinowicz 2021), and commercial success evidence. These will be weighed against the strong prima facie case.

VII. Bottom-line assessment

On the present record, the most plausible § 103 combination — and the one most likely to result in a finding of obviousness if the priority-date hurdle is cleared — is:

Gwozdz PCT (EX1009) in view of Meezan '962 (supplemented, as needed, by US 5,661,130 / US 2009/0047347 for DDM and by Diastat/Valium or Gwozdz's own disclosure for the ethanol + benzyl alcohol co-solvent system), rendering obvious the '786 composition claims:

• Gwozdz supplies the diazepam/tocopherol (30–95%)/alcohol (5–70%) nasal solution with benzyl alcohol as a disclosed alcohol, in overlapping ranges;
• Meezan supplies n-dodecyl β-D-maltoside as a known intranasal absorption enhancer; and
• a POSITA would be motivated to combine them to increase the rate and amount of intranasal diazepam absorption for rapid seizure control, with a reasonable expectation of success, because enhancer addition and co-solvent rebalancing were routine formulation techniques in 2008–2009 and were not taught away from.

The countervailing considerations are real but, on the IPR2019-00451 precedent (affirmed by the Federal Circuit), historically insufficient as to motivation; the genuinely open questions in IPR2025-00466 are (i) priority-date entitlement of the specific '786 claim language to the 2008 provisional, and (ii) whether DDM's function in a non-aqueous vehicle was predictable enough to satisfy the reasonable-expectation-of-success prong. Trial was instituted, with the PTAB hearing scheduled for June 16, 2026 and a projected final written decision by September 17, 2026; a final determination on these § 103 grounds is therefore pending and cannot yet be predicted with certainty.

This analysis is based on the specification text supplied, the public IPR/litigation record identified above, and related family documents. I was unable to verify the verbatim granted claims of US11793786B2 or its formal citation list from the materials provided; specific claim-element mapping should be re-checked against the actual granted claims and the IPR2025-00466 institution decision before reliance.