US 12599611

I'll search for the specific patent number and any CAFC docket information.

Let me run additional targeted searches on USPTO records and CAFC dockets.

Let me search specifically for CAFC appeal activity and the USPTO Patent Center record.

Based on my searches, here is the requested summary. I could not locate any CAFC 2026 docket activity tied to this patent number, and I'll flag that explicitly.

US Patent 12,599,611 B2 — Summary

Verified bibliographic data (consistent across USPTO/Google Patents records, PatentGuru, Espacenet, and drug-patent databases):

• Title: Methods and compositions for treating seizure disorders in pediatric patients
• Patent number: US12599611B2 (application no. US17/837,198)
• Assignee (current): Neurelis, Inc. (San Diego, CA)
• Inventors: Adrian L. Rabinowicz; Enrique J. Carrazana
• Filing date: June 10, 2022 (US non-provisional)
• Priority date: June 10, 2021 (Provisional App. No. 63/209,092)
• Issue date (grant): April 14, 2026 (publication of B2)
• Status: Active; expected expiration June 10, 2042
• Prosecution counsel: reported as DLA Piper LLP
• Key classifications: A61K31/5513 (1,4-benzodiazepines, e.g., diazepam); A61K9/0043 (nasal); A61P25/08 (antiepileptics/anticonvulsants); related A61K31/355 (tocopherols), A61K31/7016 (disaccharides), A61K47/10, etc.

Abstract (verbatim):

"Compositions for intranasal delivery of benzodiazepines, such as diazepam, midazolam, and lorazepam and methods for their use to treat and prevent seizures in pediatric subjects aged 2-5, inclusive. Compositions for rapid therapeutic onset with a decreased incidence and/or severity of adverse effects after administration and methods of improving patient compliance with a prescribed treatment regimen."

CAFC 2026 docket search: No Federal Circuit appeal, petition, or litigation referencing patent 12,599,611 (or Neurelis, Inc. in a 2026 CAFC matter) was found in my searches. Note: I could not access the live CAFC docket directly; this is based on web searches of CAFC docket aggregators (FedCircuitBlog coverage through Sept 2026 and general web results), which surfaced no matching case. Treat the absence of appeal activity as probable but not definitively confirmed.

Plain-language overview of the independent claims

Caveat: The granted claims text was not fully present in the fetched record (Google Patents capture truncated before the formal Claims section). The specification's "Further Embodiments" recite two independent claim sets, which almost certainly correspond to the granted independent claims, but I cannot confirm exact claim numbering/wording without the USPTO's granted-claims text.

Independent claim set 1 (likely claim 1) — Method of treating a pediatric subject having a seizure disorder:
Administers, to a subject aged 2–5 years (inclusive), an intranasal composition containing (i) an effective amount of diazepam, (ii) an alkyl maltoside, and (iii) a carrier system of one or more natural/synthetic tocopherols or tocotrienols plus one or more alcohols. The composition is applied to the nasal mucosal membrane to treat the seizure disorder. In plain terms: a treatment method for 2–5-year-olds with epilepsy/seizure disorders using a specific diazepam nasal-spray formulation (the Valtoco®-type platform), defined by the drug, a permeation-enhancing sugar-lipid (alkyl maltoside, e.g., DDM), and a vitamin-E/alcohol solvent vehicle.

Independent claim set 2 (likely a later independent claim) — Method of treating recurrent seizures:
Administers the same type of diazepam/alkyl-maltoside/tocopherol-alcohol carrier composition to a 2–5-year-old subject's nasal mucosa during or before a seizure to treat recurrent seizures (e.g., seizure clusters / acute repetitive seizures). In plain terms: covers rescue-style dosing timed to an individual seizure event rather than general treatment of the underlying disorder.

Dependent scope covered by the specification's embodiments (dependent claims): diazepam doses of ~2–20 mg in ~10–200 μL (e.g., 5–15 mg/100–200 μL); single-use pre-primed device containing ~100 μL; delivery to one nostril (5–10 mg/100 μL) or split dosing to both nostrils (e.g., 7.5 mg/100 μL per nostril); DDM and/or TDM at ~0.1–1% w/v; ethanol + benzyl alcohol mixture (e.g., ~17–20% w/v ethanol and ~10–12% w/v benzyl alcohol); clinical seizure-activity reduction or second-seizure prevention for ≥8, ≥24, or ≥48 hours; no second dose needed within 24 hours; epilepsy/ epileptic disorder; caregiver administration; timing in prodromal/pre-ictal or ictal phases; and ~90–110% bioavailability relative to IV diazepam.

Uncertainty notes: (1) Exact granted claim numbering/wording is unconfirmed because the fetched record lacked the formal claims section — the above is drawn from the specification's embodiment lists, which mirror the claims but are not verbatim granted claims. (2) The first web hit returned ("Office Action Analysis: 18000962 — RNA PURIFICATION METHOD") mentions "Patent 12599611" only as a cross-reference on a page about a different application (18/000,962) and is not authoritative for this patent's substantive record. (3) No Orange Book/legal-status representations beyond the "Active" status and 2042 expiration date were independently verified against USPTO Patent Center.

Based on targeted searches of CourtListener/PACER-derived dockets, DrugPatentWatch, Ex Parte, and related litigation trackers, here is what I found regarding litigation specifically involving US Patent No. 12,599,611 (the "'611 patent," titled "Methods and Compositions for Treating Seizure Disorders in Pediatric Patients," owned by Neurelis, Inc.).

Known litigation involving US Patent 12,599,611

1. Neurelis, Inc. v. Strides Pharma Global PTE Limited et al.

• Plaintiff: Neurelis, Inc.
• Defendants: Strides Pharma Global PTE Limited (Singapore) and Strides Pharma, Inc. (New Jersey)
• Jurisdiction: U.S. District Court for the District of Delaware
• Case number: 1:26-cv-00947-MN
• Filing date: July 31, 2026 (per docket entries; complaint filed July 31, 2026)
• Cause of action: 35 U.S.C. § 271 patent infringement (Hatch-Waxman / ANDA; Nature of Suit 835); no jury demand
• Judge: Maryellen Noreika (case assigned August 5, 2026)
• Patents-in-suit: The complaint and docket reports list the '611 patent alongside U.S. Patent Nos. 11,241,414; 11,793,786; 12,268,664; 12,324,852; 12,337,061; and 12,521,400.
• Core allegations: Strides submitted ANDA No. 221329 seeking FDA approval for a generic diazepam nasal spray (5 mg, 7.5 mg, and 10 mg/spray, i.e., a generic version of VALTOCO®). Neurelis alleges that by submitting the ANDA Strides infringed claims 1–33 of the '611 patent under 35 U.S.C. § 271(e)(2)(A), and that the proposed label instructs/encourages treating pediatric patients under age 6, supporting claims of induced/contributory infringement. The '611 patent claims methods of treating seizure disorders in pediatric subjects aged 2–5 via intranasal diazepam.
• Status/Outcome: Open/pending as of the most recent docket updates (late August 2026). The complaint was filed 7/31/2026; summonses issued and served on defendants (served 8/5/2026); answer deadlines were extended by stipulation (SO ORDERED 8/25/2026). Per the ANDA supplemental filing, Neurelis received the Paragraph IV notice on 06/18/2026, and the 30-month stay deadline is noted as 12/18/2028. DrugPatentWatch (last updated September 1, 2026) lists this as the only district court case for patent 12,599,611, with no termination date.

Important notes / caveats

• Other Neurelis VALTOCO® ANDA litigations do NOT involve the '611 patent. The related consolidated D. Del. actions against Padagis LLC (e.g., 1:24-cv-00562, 1:25-cv-00821, 1:25-cv-01228, 1:26-cv-00401), Lupin (e.g., 1:26-cv-00258 / related), Amneal (1:26-cv-00261), and others assert the '546, '414, '786, '664, '852, '061, and '400 patents — not the '611 patent. Similarly, the PTAB inter partes reviews filed by Padagis (IPR2025-00464, -00465, -00466) challenge the '546, '414, and '786 patents, not the '611 patent.
• Date discrepancy: You noted today's date as April 26, 2026, but the search results describe filings dated July 31, 2026 and later. Per your instruction that live search results are the current ground truth over my training data, I am reporting the case as reflected in those search results. If your internal clock is correct (April 2026), the Strides case would be prospective/not yet on the docket; however, the retrieved CourtListener, Ex Parte, and DrugPatentWatch pages all consistently show the case as filed 7/31/2026 and open.
• No other litigation, PTAB challenges, or prior cases naming the '611 patent were identified in these searches. If it exists, litigation naming this patent may be very recent (the patent only granted April 14, 2026).

The initial structured data says there are no AIA proceedings on file for this patent, but given the patent issued in April 2026 and sits in the hotly-litigated Neurelis/VALTOCO® family, let me run targeted verification searches before concluding.

Proceedings overview

Zero AIA trial proceedings exist on US Patent 12,599,611. The USPTO Open Data Portal ingest underlying the "PTAB proceedings on file" block returns no IPR/PGR/CBM for this patent, and targeted web searches (DocketAlarm, PTAB E2E mirrors, drugpatentwatch, CourtListener) surfaced no petition directed at the '611. The breakdown is trivially: 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution-denied. The bottom line for a defendant: the '611 is untested at the PTAB — every claim stands un-narrowed — but the absence of proceedings is structurally expected, not a sign of strength. The patent issued only on 2026-04-14, and under 35 U.S.C. § 311(c) no IPR (and under § 321(c) no PGR) may even be filed before 2027-01-14 (nine months post-grant). As of today (2026-09-09), no petitioner is statutorily eligible to challenge it yet.

There is therefore no proceeding-by-proceeding section to write — no FWDs, settlements, or CAFC appeals exist to report for this patent. What follows is the verification trail, the closely-related family-patent context you must not confuse with proceedings on the '611, and the strategic read for a defendant.

Verified absence (and the false leads to ignore)

• DrugPatentWatch litigation page for patent 12,599,611 (last updated 2026-09-01) lists exactly one district-court matter — Neurelis, Inc. v. Strides Pharma Global PTE Limited, D. Del. 1:26-cv-00947, filed 2026-07-31 (35:271; no jury demand) — and no PTAB cases for this patent. (https://www.drugpatentwatch.com/p/litigation/patent/12599611)
• One search hit referenced "IPR2022-01259 … Samsung v. AlmondNet" — that is an unrelated advertising-patent case; it surfaced only as a keyword artifact and has nothing to do with the '611.
• The prior search hit "Office Action Analysis: 18000962 — RNA PURIFICATION METHOD," which mentions "Patent 12599611," is a cross-reference on a different application's page and is not authoritative for this patent's PTAB record.
• No Federal Circuit appeal involving the '611 exists (consistent with the earlier CAFC search in the prior section of this analysis).

Closely-related proceedings not on the '611 (do not conflate)

The '611 is the newest Orange Book-listed member of the Neurelis/VALTOCO® diazepam-nasal-spray patent cluster, and other members of that cluster are under heavy PTAB fire:

• IPR2019-00449/-00450/-00451 — Aquestive Therapeutics, Inc. v. Neurelis, Inc. (challenging U.S. 9,763,876, the Valtoco® formulation patent). The '451 IPR was instituted on 2019-08-13 and resulted in a Final Written Decision on 2020-08-06 finding all 36 claims of the '876 patent unpatentable as obvious over Gwozdz (WO 2009/120933) in view of Meezan; the Federal Circuit affirmed. ('449 and '450 were denied institution.) (https://hbiplaw.com/library-posts/announcements/hoffmann-baron-on-behalf-of-aquestive-inc-successfully-invalidates-all-claims-of-orange-book-patent-for-valtoco-nasal-spray-in-aquestive-therapeutics-inc-v-neurelis-inc/)
• IPR2025-00464/-00465/-00466 — Padagis US LLC v. Neurelis, Inc. (filed 2025-01-17; challenging U.S. 8,895,546; 11,241,414; and 11,793,786, respectively). The Board instituted all three for trial (trial date 2026-06-16; projected FWD due 2026-09-17), after the Acting Director declined discretionary denial in an order designated informative on 2026-01-09 — reasoning that the claims overlapped subject matter already held unpatentable in IPR2019-00451 and that the examiner's contrary priority-date conclusion (entitlement to the '558 provisional) raised a concern of material error under Advanced Bionics. (https://www.docketalarm.com/cases/PTAB/IPR2025-00464/Padagis_US_LLC_v._Neurelis_Inc/; https://www.ptablitigationblog.com/informative-no-discretionary-denial-where-prior-ipr-suggests-material-error-by-office/)

None of these petitions names the '611. They target the formulation patents claiming priority back to March 2008, whereas the '611 claims priority to the June 10, 2021 provisional (63/209,092) and claims methods of treating 2–5-year-old pediatric patients — a different priority anchor and different claim scope.

Strategic summary

Claims CANCELED vs. SUSTAINED vs. UNTESTED on the '611 itself: All claims of US 12,599,611 are UNTESTED — none have been challenged in any AIA proceeding, none canceled, none sustained. The exact granted claim set is unconfirmed from the fetched record (the Google Patents capture truncated before the formal Claims section), but based on the specification's embodiment lists the independent claims are the two method sets (treating a 2–5-year-old with the diazepam/alkyl-maltoside/tocopherol-alcohol intranasal composition, and treating recurrent seizures by administration during or before a seizure). All of those claims currently stand in full force.

Estoppel landscape (§ 315(e)(2)): Because no proceeding has been instituted on the '611, no estoppel attaches to anyone with respect to grounds against the '611. All prior-art grounds remain available to any future petitioner. One practical caveat: the Padagis IPRs and the Aquestive IPR concerned family members with a March 2008 priority anchor, and the Gwozdz/Meezan combination was found to invalidate the overlapping formulation claims — those findings are persuasive (and in some configurations preclusive vis-à-vis privies on issues actually litigated) but are not directly binding on the '611's pediatric method claims with a 2021 priority date.

Pattern signals: The pattern is unambiguous — Neurelis's VALTOCO® Orange Book portfolio is a magnet for serial IPR attack by generic ANDA filers. Aquestive took down the '876 entirely (affirmed); Padagis has three instituted IPRs on sibling patents with FWDs due 2026-09-17; and the '611 is now asserted against Strides in D. Del. (1:26-cv-00947, filed 2026-07-31, Judge Noreika, no jury demand). The '611 is also listed in the Strides complaint among the seven VALTOCO patents, confirming it is part of the Paragraph IV battlefield (https://www.courtlistener.com/docket/73702976/1/neurelis-inc-v-strides-pharma-global-pte-limited/). Neurelis litigates ANDA cases aggressively (multiple consolidated D. Del. actions; bench trials scheduled 2027), and the Padagis IPR history shows Neurelis will contest institution hard on discretionary grounds. There is no defensive-aggregator (e.g., Unified Patents) involvement visible on any of these matters.

Recommended next steps

• If you are a defendant being asserted against under the '611 today (e.g., Strides or a future ANDA filer): recognize the window. The § 315(b) one-year clock runs from service of the ANDA complaint (served ~August 2026 for Strides), but the § 311(c) nine-month post-grant bar means no IPR petition on the '611 may be filed before 2027-01-14. A petition filed between 2027-01-14 and roughly 2027-07-31 would satisfy both statutes — do not file early (rejected as premature), and do not sleep past the § 315(b) date.
• Mine the Padagis FWDs when they land (projected 2026-09-17) in IPR2025-00464/-00465/-00466. To the extent the Board again finds the Gwozdz/Meezan combination and priority-date analysis fatal to the overlapping formulation limitations, that gives you a ready-made § 103 template for the formulation elements embedded in the '611's method claims — though you will still need separate art or argument addressing the pediatric 2–5 population and method-of-treatment limitations, since the '611's priority date (2021-06-10) post-dates Gwozdz's publication regardless.
• Monitor the CAFC docket for appeals from the Padagis IPRs and any post-remand activity in the '876 matter; a Federal Circuit affirmance of the Padagis FWDs would strengthen collateral-estoppel and obviousness positions against the whole Valtoco family, including the '611's dependent formulation features.
• In district court: the Strides case (and consolidated Neurelis ANDA actions) is a bench trial before Judge Noreika scheduled into 2027; coordinate any PTAB timing with the court's schedule and consider a stay motion keyed to a 2027-01-14 IPR filing.

Bottom line, stated plainly: there is no PTAB history on US 12,599,611 to exploit or to fear — yet. The patent is virgin ground, freshly granted, already in ANDA litigation, and sitting in a family whose sibling patents have a demonstrated record of falling at the PTAB. The absence of proceedings today is a statutory artifact of the nine-month bar, not a durability signal — expect Paragraph IV petitioners to come for the '611 at the earliest lawful moment, 2027-01-14.

I'll research the assignment record for US 12,599,611. Let me run several targeted searches.

Let me run more targeted searches on the specific assignment events and related Neurelis corporate history.

The searches confirm the OrbiMed/Aegis/Neurelis transaction context. Now let me try to pin down reel/frame numbers and any correspondent details.

I have reached the search step limit, so I'll now synthesize the available evidence. Important caveat up front: I could not access the USPTO Assignment Center's live record detail pages during this session, so reel/frame numbers and correspondent-of-record names could not be independently verified. The events and dates below come from the Google Patents legal-event feed embedded in the authoritative patent text, corroborated by a Neurelis corporate press release dated November 14, 2024. I have not fabricated any reel/frame or correspondent data.

Inventors

• Adrian L. Rabinowicz — Neurelis-affiliated; a repeat inventor on the Neurelis/Aegis Therapeutics Valtoco patent families (public roles include Neurelis clinical/medical executive). At filing (2021–2022) he was with Neurelis, the named applicant. His recorded assignment (recorded 2022-10-13) runs to Neurelis, Inc.
• Enrique J. Carrazana — Neurelis-affiliated (public roles include Neurelis chief medical officer); also a repeat inventor on the Neurelis/Aegis families. His recorded assignment (recorded 2022-10-13) runs to Neurelis, Inc.

Unusual pattern check: none present. Both inventors assigned to the operating applicant company rather than to any third party, and there is no evidence of post-filing departures or a portfolio fire-sale in the inventor layer.

Original assignee

• Neurelis, Inc. (San Diego, CA) — named applicant and assignee on the issued patent.
• Product: Yes — Neurelis markets Valtoco® (diazepam) nasal spray, FDA-approved January 10, 2020, for seizure clusters in epilepsy patients ≥6 years. This patent's method claims cover the same Valtoco-type formulation used in pediatric subjects aged 2–5 (inclusive), an extension of the marketed product's use. The patent is tracked as a Neurelis drug patent (expiry June 10, 2042) by third-party patent databases.
• Primary line of business: commercial-stage specialty pharmaceutical company developing and selling nasal rescue therapies (epilepsy seizure clusters, and via subsidiary Aegis Therapeutics, the Intravail® alkyl-maltoside drug-delivery platform licensed to other pharma partners, e.g., neffy® nasal epinephrine).
• Current status: operating. Privately held; no bankruptcy, dissolution, or acquisition evidence. November 14, 2024 press release shows it monetized Intravail royalty receivables to OrbiMed for $208 million — a cash-generating financing event, not distress.

Assignment timeline

Recorded-assignment events for US application 17/837,198 (later US 12,599,611), per the Google Patents legal-event feed in the authoritative record. Reel/frame numbers and correspondent names are unverified — I did not have live Assignment Center access, and web-indexed copies of these specific cover sheets did not surface. Verify at the USPTO Assignment Center (https://assignmentcenter.uspto.gov) by searching patent number 12599611 or application 17/837,198.

• executed date not verified / recorded 2022-10-13 — Reel/frame not verified

  • Conveyance: Assignment of Assignor's Interest (inventor → company)
  • Assignor: Enrique J. Carrazana
  • Assignee: Neurelis, Inc.
  • Correspondent: not verified
  • Context: Standard inventor-to-employer assignment, recorded four months after the June 10, 2022 non-provisional filing and before the December 22, 2022 publication. Routine; no NPE signal.

• executed date not verified / recorded 2022-10-13 — Reel/frame not verified

  • Conveyance: Assignment of Assignor's Interest (inventor → company)
  • Assignor: Adrian L. Rabinowicz
  • Assignee: Neurelis, Inc.
  • Correspondent: not verified
  • Context: Same routine inventor-to-employer assignment as above, recorded as a separate per-inventor record on the same date. Routine.

• executed date not verified / recorded 2023-06-04 — Reel/frame not verified

  • Conveyance: Security Interest (grant of lien, not an ownership transfer)
  • Assignor: Aegis Therapeutics, LLC and Neurelis, Inc.
  • Assignee: OrbiMed Royalty & Credit Opportunities III, LP
  • Correspondent: not verified
  • Context: Portfolio-level secured financing — Neurelis and its subsidiary Aegis pledged IP (including this application) to OrbiMed, a healthcare royalty/credit investment firm, as collateral. Consistent with OrbiMed's later $208 million royalty monetization announced November 14, 2024.

• executed date not verified / recorded 2024-11-14 — Reel/frame not verified

  • Conveyance: Release of Security Interest
  • Assignor: OrbiMed Royalty & Credit Opportunities III, LP
  • Assignee: Neurelis, Inc. and Aegis Therapeutics, LLC
  • Correspondent: not verified
  • Context: Release of the OrbiMed lien back to Neurelis/Aegis, recorded on the same date as Neurelis's November 14, 2024 announcement of the OrbiMed Intravail royalty transaction. Ownership returns to and stays with the operating company.

Note: If the Assignment Center shows additional records beyond these four (e.g., an earlier Aegis → Neurelis chain for the broader family), they would not be recorded against this specific application number and are outside this patent's record. The chain of title for US 12,599,611 itself is: inventors → Neurelis (2022), lien to OrbiMed (2023), release back to Neurelis/Aegis (2024).

Timeline diagram

timeline
    title Ownership of US 12599611
    2021 : Provisional application filed
    2022 : Nonprovisional filed by Neurelis
         : Inventors assign rights to Neurelis
    2023 : Security interest granted to OrbiMed
    2024 : Security interest released to Neurelis
    2026 : Patent granted to Neurelis

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only non-Neurelis entity ever in the chain is OrbiMed Royalty & Credit Opportunities III, LP, a large healthcare royalty/credit investment manager, and its interest was a security interest (collateral lien) recorded 2023-06-04 and released back to Neurelis, Inc. and Aegis Therapeutics, LLC on 2024-11-14. Aegis is Neurelis's own subsidiary (the Intravail platform licensor), not an unrelated licensing-only shell. No transfer to any "IP Holdings / Licensing / Ventures" LLC occurred.

2. Known asserter in the chain — not present. Neurelis is a commercial-stage pharmaceutical company, not on public NPE lists (Acacia, Marathon, IV, Conversant, etc.). OrbiMed is a healthcare investment firm that takes royalty/security positions, not a patent-assertion NPE. Neither matches any Unified Patents / RPX high-frequency-plaintiff directory.

3. Repeat correspondent across the chain — unclear (data unavailable). I could not retrieve correspondent-of-record names for any of the four recorded conveyances, so recurrence cannot be assessed. No inference is drawn.

4. Cascading transfers — not present. Only three substantive transactions over ~2.5 years (inventor assignments, a secured lien, and its release), all involving the same two operating/affiliated entities. No chained LLC-to-LLC sequence exists.

5. Pre-litigation transfer — not present / no evidence. No infringement suit naming US 12,599,611 within six months of any recorded conveyance was found. (Related-family Hatch-Waxman/IPR activity involving Neurelis and Padagis concerns the older '546 composition patent, not this one, and is defense of an Orange Book patent by an operating company.)

6. Bankruptcy fire-sale — not present. Neurelis remains operating and, per its November 14, 2024 release, monetized royalties for $208 million — the opposite of a distress sale. OrbiMed's involvement is secured lending/royalty financing.

7. Privateering — not present. No transfer of the patent to any third-party NPE for assertion on Neurelis's behalf. The patent has never left the Neurelis/Aegis orbit.

8. Defensive aggregator (anti-NPE) — not present. The chain terminates at Neurelis, Inc., the operating owner. No RPX/AST/LOT/Unified/OIN involvement.

Verdict

Operating-company assertion

The chain of title runs entirely within an operating pharmaceutical company: inventors → Neurelis, Inc. (2022-10-13), a collateral security interest to healthcare financier OrbiMed (2023-06-04), and its release back to Neurelis/Aegis (2024-11-14). Neurelis ships Valtoco® (diazepam nasal spray), the product whose pediatric 2–5-year-old use the claims protect, and is not on any public NPE list; no shell-entity transfer, cascading LLC chain, bankruptcy, or privateering signal is present. I did not locate evidence of Neurelis affirmatively suing competitors on this specific patent, so the "assertion" limb rests on the product-shipping ownership context rather than a docketed suit; the dispositive point for troll analysis is that no NPE pattern exists in any form. Reel/frame numbers and correspondents could not be verified from live Assignment Center access and should be confirmed at https://assignmentcenter.uspto.gov (search: patent 12599611) before relying on this chain for litigation-standings purposes.

Prior-Art Analysis — US Patent 12,599,611 B2 ("'611 patent")

1. USPTO search result for the specific number 12599611

I searched specifically for 12599611 (US12599611B2) and did not include or confuse it with similar family numbers (11,241,414; 11,793,786; 12,268,664; 12,324,852; 12,337,061; 12,521,400). Verified from USPTO-mirroring records (Google Patents, PatentGuru, Espacenet, DrugPatentWatch/Pharsight):

Date-conflict flag: The patent issued April 14, 2026 — very recently. Consequently, the formal USPTO "References Cited" (PTO/SB-08 list printed on the patent's front page) has not yet been indexed by the free aggregators I can search (Google Patents' "Citations" tab for the B2 is empty/not captured in the fetched record, and Espacenet's "Cited documents" tab is not fully indexed for this B2). I was also unable to open USPTO Patent Center directly in this environment. I therefore cannot truthfully provide a verified, face-of-the-patent list of examiner citations for the '611 patent. What follows is (a) the most relevant prior art I could identify from the Neurelis family prosecution pattern and citation graphs, and (b) a rigorous, clearly-labeled §102 potential-anticipation analysis against the claims. Treat the claim-mapping as preliminary until the PTO-892 list is pulled from Patent Center or the issued PDF's front page.

2. The claims to analyze

The fetched record lacks the formal claims section (consistent with the prior summary). Granted claims number 1–33 (per the Strides complaint in Neurelis v. Strides Pharma, D. Del. 1:26-cv-00947, which alleges infringement of claims 1–33 of the '611 patent). The two independent claim sets, mirroring specification "Further Embodiments" A and W, are:

• Claim-type 1 (method of treating a seizure disorder): Administering, to a pediatric subject 2–5 years old (inclusive), a composition of an effective amount of diazepam, an alkyl maltoside, and a carrier of one or more tocopherols/tocotrienols plus one or more alcohols, to a nasal mucosal membrane, to treat the seizure disorder.
• Claim-type 2 (method of treating recurrent seizures): Same composition/subject/route, administered during or before a seizure.
• Dependent features (embodiments B–V, X–TT): ~2–20 mg diazepam in 10–200 μL; 5–15 mg/100–200 μL; pre-primed single-use 100 μL device; single-nostril (5–10 mg/100 μL) or split bilateral dosing (e.g., 7.5 mg/100 μL per nostril); DDM and/or TDM at ~0.1–1% w/v (specifically 0.25% DDM in the commercial formulation); ethanol+benzyl alcohol (e.g., 17–20% w/v ethanol; 10–12% w/v benzyl alcohol); ≥8/≥24/≥48 h seizure-activity reduction or second-seizure prevention; no redose within 24 h; epilepsy; caregiver administration; prodromal/pre-ictal/ictal timing; ~90–110% IV-relative bioavailability.

3. Most relevant prior art (identified, not confirmed-as-cited)

Under 35 U.S.C. § 102, a single reference must disclose every limitation of the claimed invention, arranged as in the claim, to anticipate. The dispositive limitation for this patent is the 2–5-year-old pediatric subject combined with the specific intranasal diazepam + alkyl maltoside + tocopherol/alcohol formulation. No single reference I located discloses that entire combination; the strongest references below are therefore prima facie § 103 obviousness candidates more than clean § 102 anticipations — except where noted.

A. Neurelis's own earlier "Administration of benzodiazepine compositions" family (composition + seizure use, no 2–5-year limitation)

B. Diazepam nasal-spray art outside the Neurelis family

4. Bottom-line § 102 assessment

• No identified reference is a strong single-reference § 102 anticipator of either independent claim type. The combination that makes the '611 claims novel — intranasal diazepam in the DDM/tocopherol/alcohol vehicle administered to a 2–5-year-old — is split across the art: Neurelis/VALTOCO disclosures teach the formulation and rescue use but at ≥6 years; the DIASTAT label teaches ≥2 years but only rectally; CN111529489A (unreviewable in full here) might teach an intranasal diazepam spray for a broader population but its complete disclosure could not be confirmed.
• The realistic invalidity theories against claims 1–33 are therefore § 103 obviousness combinations (e.g., VALTOCO formulation/label + DIASTAT pediatric-2-years label/0.5 mg/kg dosing + routine age-ranging of a known rescue medicine), not § 102 anticipation — consistent with the Paragraph IV posture in Neurelis v. Strides (1:26-cv-00947), where the ANDA challenger's notice letter alleged the Neurelis patents are invalid (grounds not yet particularized in the public docket excerpts I retrieved).
• Dependent-claim nuances: References that do not anticipate claim 1 cannot anticipate claims adding the 2–5-year, nostril-split, device, bioavailability (90–110% of IV), or ≥8/24/48-hour-seizure-prevention limitations; those would require the same missing disclosures.

5. Confidence and next steps

• High confidence: bibliographic data; claim count 1–33; VALTOCO ≥6-year indication; DIASTAT ≥2-year rectal indication; family/common-ownership relationships.
• Explicitly unknown: the actual examiner-cited references printed on the '611 patent (PTO/SB-08 list), because the June/September 2026 indexable records for this April 14, 2026 grant do not yet include the citations tab. I did not fabricate a face-of-patent citation list.
• To complete this task definitively: pull the front page of the issued B2 PDF from USPTO Patent Center (application 17/837,198) or the USPTO full-text image database, and transcribe the "References Cited" block; then re-run the § 102 mapping against that verified list. I also recommend obtaining the § 1.56 Information Disclosure Statements from the file wrapper, which will show the applicant-submitted references (likely including the VALTOCO and DIASTAT labels and the PK/PD papers quoted in the specification).

Preliminary caveats (read first)

1. No "Prior Art" section was included in the provided materials. The task instructs me to "[u]se the results from the Prior Art section of this page," but no such section appears in the previously generated patent/litigation summaries. I therefore reconstructed the applicable prior-art landscape via live searches (which, per the operating rules, supersede my training data where they conflict) plus the intrinsic record of the VALTOCO®/Neurelis patent family discussed in the litigation summary. Flag this gap explicitly.
2. Granted-claims text is not in hand. The fetched Google Patents record truncated before the formal Claims section, and the earlier summary correctly noted this. This analysis is built on the specification's "Further Embodiments" (which mirror the two independent claim sets) and on the Strides complaint allegation that claims 1–33 of the '611 patent are asserted. Any claim-by-claim mapping below is therefore to the claim content as disclosed, not to verified granted claim wording.
3. Governing law. The '611 patent (non-provisional filed June 10, 2022; priority June 10, 2021) is examined under post-AIA 35 U.S.C. § 103 (art publicly available or effectively filed before June 10, 2021 qualifies). The Graham framework and KSR "obvious to try"/"design need" reasoning apply.

1. Claim scope and the real inventive hook

The two independent claim sets (mirroring the specification's "Further Embodiments A" and "W") require:

• A method of treating a seizure disorder / recurrent seizures in a pediatric subject 2–5 years old (inclusive);
• by administering to a nasal mucosal membrane a composition containing an effective amount of diazepam, an alkyl maltoside (DDM/TDM), and a carrier system of one or more tocopherols/tocotrienols + one or more alcohols.

Dependent content adds: 2–20 mg diazepam in 10–200 μL (5–15 mg/100–200 μL); a pre-primed single-use ~100 μL device; 5–10 mg/100 μL to one nostril or 7.5 mg/100 μL per nostril; 0.1–1% w/v alkyl maltoside; ethanol + benzyl alcohol (e.g., 17–20% + 10–12% w/v); ≥8/24/48-hr reduction of clinical seizure activity or prevention of a second seizure; no second dose needed within 24 hrs; epilepsy; caregiver administration; prodromal/pre-ictal or ictal timing; and ~90–110% IV bioavailability.

Critically, the formulation itself was old and, more importantly, was already the subject of adjudicated obviousness findings in this exact patent family (see §2). The only genuinely new limitation is the patient age window (2–5 years) and treatment parameters tied to that window. That framing drives the entire §103 analysis: the composition and route are known; the question is whether extending an approved/known intranasal diazepam rescue therapy to 2–5-year-olds was obvious.

2. The composition and route were already found obvious in the family's own IPR history

This is the single most important prior-art fact:

• U.S. Patent 9,763,876 B2 ("the '876 patent," "Administration of benzodiazepine compositions," issue date Sept. 19, 2017) — the VALTOCO® Orange Book patent of the same Neurelis family — claimed: "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 … consisting of a benzodiazepine drug, one or more natural or synthetic tocopherols or tocotrienols … 30–95% (w/w); ethanol and benzyl alcohol … 10–70% (w/w); and an alkyl glycoside." (DrugPatentWatch claims listing; Federal Circuit brief in the IPR appeal.)
• In IPR2019-00451 (Aquestive Therapeutics v. Hale Biopharma/Neurelis), the PTAB's Final Written Decision (Aug. 6, 2020) held all 36 claims unpatentable as obvious over Gwozdz (WO 2009/120933) + Meezan (US 2006/0046962) (claims 17–23 over Gwozdz + Meezan + Cartt US 2008/0279784), and the Federal Circuit affirmed without opinion (Hoffmann & Baron announcement; PTACTS/Padagis IPR2025-00464 papers; Banner Witcoff copy of the FWD, Paper 44).

What Gwozdz + Meezan supplied:

• Gwozdz (PCT/US2009/038518, published Oct. 1, 2009): intranasal pharmaceutical solutions of diazepam in 30–99% (w/w) tocopherols/tocotrienols (e.g., α-tocopherol, "vitamin E") plus ethanol and benzyl alcohol (1–70% w/w), for treating patients via the nasal mucosa — including, per the FWD, methods of treatment with these solutions and use of "penetration enhancers."
• Meezan (US 2006/0046962): n-dodecyl β-D-maltoside and other alkyl glycosides as intranasal absorption enhancers, teaching bioavailabilities "from 3% up to 98%," applicable to small molecules and anti-seizure agents, in aqueous or non-aqueous carriers.
• The Board expressly credited expert testimony that a POSA would expect to achieve bioavailability approaching 100% (claims 34–36 of the '876 patent), based on diazepam's ~100% oral bioavailability plus the oral-absorption phase inherent in nasal dosing — the same ~90–110% IV-bioavailability figure now found in the '611 dependent claims.

Implication for the '611: A method claim of "administering diazepam + tocopherol + ethanol/benzyl alcohol + alkyl maltoside to the nasal mucosa to treat a benzodiazepine-treatable disorder (e.g., seizures)" was already held obvious in 2020 — before the '611 priority date (June 10, 2021). The '611 adds only the 2–5-year-old population and pediatric-specific parameters.

3. The 2–5-year-old population and dosing were squarely addressed by prior art

DIASTAT® (diazepam rectal gel) — approved since 1997 for patients ≥2 years:

• Indication: management of selected, refractory epilepsy patients on stable AED regimens "who require intermittent use of diazepam to control bouts of increased seizure activity … for patients 2 years and older."
• Dosing table for ages 2–5: 0.5 mg/kg, with weight bins: 6–10 kg → 5 mg; 11–15 kg → 7.5 mg; 16–20 kg → 10 mg; etc. (Diastat AcuDial dosing card; Drugs.com Diastat dosage pages.) This is the exact dose-strength ladder (5/7.5/10 mg) used in the '611's Example 2 PK study (6–11 kg → 5 mg; per the truncated text, weight-tiered dosing at ~0.5 mg/kg).
• Known limitations motivating an alternative route: "social and legal restrictions related to the route of administration," highly variable absorption, and risk of bowel-movement expulsion requiring re-dosing — all recited in the '611 specification itself as background.

VALTOCO® (diazepam nasal spray) — FDA-approved Jan. 2020 for patients ≥6 years:

• The approved product is the claimed formulation class: diazepam 5/7.5/10 mg per 100 μL single-use, pre-primed spray; excipients vitamin E, 0.25% (0.025 mg/100 μL) dodecyl maltoside, benzyl alcohol, ethanol (Neurelis press releases; the '611 spec's own Example 2 states "[t]he VALTOCO® formulation contains 0.25% dodecyl maltoside (0.025 mg/100 μL)").
• Pre-2021 publications (recited in the '611 spec as background): diazepam nasal spray had bioavailability similar to, but less interpatient variability than, diazepam rectal gel in healthy adults; PK profiles were similar in interictal vs ictal/peri-ictal periods; long-term safety in patients 6–65 consistent with rectal gel (e.g., Boddu & Kumari, "A short review on the intranasal delivery of diazepam for treating acute repetitive seizures," Pharmaceutics 12(12):1167 (2020) — 33 Scopus citations).
• The '611 spec itself concedes the state of the art: "Younger children also may require out-of-hospital treatment for seizure clusters … Diazepam nasal spray represents another diazepam formulation that may be easier to use and could potentially provide more predictable blood levels than rectal gel in this population." That sentence is essentially a roadmap to the obviousness conclusion.

Pediatric intranasal benzodiazepine literature: By 2021 it was well established that intranasal benzodiazepines (midazolam, lorazepam; diazepam IV-solution off-label intranasal use) are effective, safe rescue agents in young children, frequently compared head-to-head with rectal diazepam in children including the 2–5-year range; rectal diazepam at 0.5 mg/kg was the AAP-endorsed first-line out-of-hospital therapy for children without IV access. A POSA therefore had both (i) an approved diazepam rescue therapy covering ages 2–5 (rectal), and (ii) published support for intranasal benzodiazepine rescue in that same pediatric population.

4. Obviousness grounds and motivation-to-combine analysis

Ground 1 — Primary ground: Known/approved diazepam nasal-spray formulation (VALTOCO platform, as disclosed in the Neurelis family patents and/or the 2020 product label) + DIASTAT® pediatric labeling (ages 2–5, 0.5 mg/kg weight-tiered dosing)

Reference combination:

• Primary: The '876/'546 family disclosures of the diazepam–vitamin E–ethanol–benzyl alcohol–dodecyl maltoside intranasal solution and its use to treat seizures (e.g., US 8,895,546 and US 9,763,876, both issued pre-2021; the VALTOCO FDA label, Jan. 2020), which taught the composition, the nasal-spray route, the 100 μL single-use device, the 5/7.5/10 mg strengths, and the ~96–110% IV bioavailability.
• Secondary: DIASTAT® package insert/dosing materials teaching diazepam rescue therapy in epilepsy patients aged 2 years and older, with the age-2–5, 0.5 mg/kg, 5/7.5/10 mg weight-tiered dosing table, and the recognized deficiencies of the rectal route (social stigma, erratic absorption, expulsion risk).

Motivation to combine: A POSA (a clinical neurologist/epileptologist and/or pharmaceutical scientist developing rescue therapies) seeking an improved out-of-hospital rescue treatment for seizure clusters in 2–5-year-olds — a population already treatable with diazepam rectally — would be motivated to substitute the recently approved, socially acceptable, more predictably absorbed intranasal diazepam spray for the rectal gel in that same age band. The references share the identical active ingredient, identical indication (intermittent rescue of bouts of increased seizure activity in epilepsy), and overlapping dose strengths. Because the nasal spray had already demonstrated PK comparable to (and less variable than) the rectal gel in adults, the only variable was the pediatric age window — and diazepam's safety and weight-based dosing in exactly that window (2–5 years) were already established by DIASTAT. Extending an approved product's label/use from ≥6 years down to 2–5 years, where the same drug by a different route was already approved, is a routine, predictable extrapolation — squarely "obvious to try" with a finite set of expected, predictable solutions under KSR. The FDA's Orphan Drug "clinically superior" designation for the intranasal route over rectal (Neurelis press release) is evidence of route superiority, not of non-obviousness of the age extension.

Ground 2 — Fallback composition ground: Gwozdz (WO 2009/120933) + Meezan (US 2006/0046962) [+ Cartt (US 2008/0279784)] + DIASTAT®/pediatric intranasal literature

Reference combination: If the VALTOCO product disclosures were for any reason not treated as prior art against the '611's specific formulation ranges, the identical formulation was independently obvious over Gwozdz + Meezan (with Cartt supplying one-nostril/both-nostril/alternating administration patterns) — precisely the combination the PTAB credited in IPR2019-00451 (FWD Aug. 6, 2020; affirmed) for method claims of administering the diazepam/tocopherol/alcohol/alkyl-glycoside nasal solution to treat benzodiazepine-treatable disorders. Adding DIASTAT (or the pediatric intranasal midazolam/diazepam literature) supplies the 2–5-year-old subject population, the seizure-cluster/ARS indication, the 0.5 mg/kg weight-tiered dosing, and the motivation (rectal-route drawbacks; need for a caregiver-friendly out-of-hospital rescue in younger children).

Expectation of success: High. Gwozdz demonstrated a stable solvent system for diazepam; Meezan demonstrated alkyl-glycoside absorption enhancement in non-aqueous as well as aqueous systems; the Board found a POSA would expect near-100% bioavailability; DIASTAT proved the safety and efficacy of intermittent diazepam rescue in 2–5-year-olds; and pediatric intranasal benzodiazepine studies (midazolam/diazepam) demonstrated nasal mucosal delivery works in young children. No claim element required anything beyond routine clinical extrapolation and routine formulation scale/device work.

Ground 3 — Dependent limitations (map to prior art)

None of these dependent limitations rises above routine optimization, label-derived dosing, or well-known device features.

5. Secondary considerations (rebuttal analysis)

The patent's own specification supplies no comparative data showing an unexpected result in 2–5-year-olds; Example 2 is a proposed PK study (no results recited in the text provided), and the background concedes the scarcity of pediatric PK data — i.e., the applicant identified a data gap, not a technical hurdle. Arguments that VALTOCO's ≥6-year indication "taught away" from younger use would be weak: age restrictions in an approved label reflect the absence of pediatric trial data and regulatory scope, not a technical teaching that nasal diazepam would be unsafe or ineffective at ages 2–5 — particularly where the same drug, same indication, and same dose strengths were already approved for 2–5-year-olds via the rectal route, and intranasal benzodiazepines were already studied in young children. Any long-felt-need argument (no socially acceptable rescue for 2–5-year-olds) points toward obviousness: the VALTOCO platform was the obvious candidate to fill it, and the family's own IPR history (all '876 claims invalidated; Federal Circuit affirmance) forecloses treating the formulation/method-of-treatment core as inventive.

6. Bottom line

The claims of US 12,599,611, read in light of the specification's embodiment lists, are vulnerable under § 103 on at least two grounds:

1. VALTOCO/Neurelis family disclosures (diazepam–vitamin E–ethanol/benzyl alcohol–DDM intranasal solution; approved 2020 for ≥6 years) in view of DIASTAT® (diazepam rectal gel approved for ≥2 years, 0.5 mg/kg weight-tiered dosing for ages 2–5) and/or pediatric intranasal-benzodiazepine literature — the primary and strongest ground, requiring only the routine extension of an approved rescue product to an adjacent pediatric age band already covered by the same drug via another route.
2. Gwozdz (WO 2009/120933) + Meezan (US 2006/0046962), optionally + Cartt (US 2008/0279784), in view of DIASTAT® and/or the pediatric intranasal literature — the formulation- and route-based ground already adjudicated in IPR2019-00451 (FWD Aug. 6, 2020, affirmed), with the pediatric population/dosing supplied by DIASTAT.

Dependent limitations (dose strengths, 100 μL single-use device, DDM concentration, alcohol concentrations, one-nostril/both-nostril administration, bioavailability, duration of effect, caregiver/timing features) all map to known product labels, family specifications, and the IPR record. A PHOSITA would have been motivated to combine these references and would have had a high expectation of success.

Persistent uncertainties: (a) exact granted claim wording/numbering remains unverified (no formal Claims section in the fetched record; the Strides complaint alleges claims 1–33); (b) I could not inspect the USPTO file wrapper to see which references the Examiner applied/allowed over — a file-wrapper review would refine the §103 analysis, especially the Examiner's reasons for allowance regarding the 2–5-year age limitation; (c) the "Prior Art section" referenced in the task was not provided, so this analysis rests on independently retrieved art.