US 12337061

I'll verify this patent's bibliographic data and claims against live sources before summarizing.

Let me pull the actual claim language and confirm the litigation docket status.

Let me pin down the remaining independent claims and confirm the exact claim set.

Summary — US Patent 12,337,061 B2

Caution on identifiers: I interpreted "12337061" literally as US 12,337,061 B2. I did not auto-correct anything, and I did not consider numbers that merely resemble it. Note one discrepancy up front: your prompt says today is April 26, 2026, but the live sources I retrieved carry "last updated" stamps of August 2026 and reference court filings dated July 31, 2026. I report what those sources state and flag it rather than reconciling it.

1. Bibliographic data

Assignee verification note: multiple independent sources (drugpatentwatch.com, GreyB/Pharsight, MTEC, and the D. Del. complaints) all list Neurelis, Inc. as owner of "the '061 patent."

2. Abstract

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

Technical field (plain language): the specification as a whole is a genus-level disclosure of non-aqueous, nasally administered benzodiazepine solutions — a benzodiazepine drug (principally diazepam), a natural or synthetic tocopherol/tocotrienol (Vitamin E) at ~30–95% w/w, an alcohol and/or glycol at ~10–70% w/w, and an alkyl glycoside (dodecyl maltoside) as a penetration enhancer. The granted claims of '061, however, are much narrower (see below).

3. Independent claims — plain-language overview

The '061 patent has 52 claims (claims 1–52 were asserted in the Amneal complaint). Secondary sources describe it as containing six independent claims. The independent claims are all method-of-use claims ("use" and "formulation" claim types per drugpatentwatch.com), not composition claims.

Common preamble to every independent claim:
A method of treating bouts of intermittent and stereotypic episodes of increased seizure activity in an epilepsy patient that is distinguishable from other seizures suffered by the patient — i.e., what the field calls seizure clusters / acute repetitive seizures. (This language is deliberately lifted from the FDA-approved Diastat® rectal diazepam labeling, as the specification itself acknowledges.)

Claim 21 — single-spray, bounded-bioavailability claim (the claim specifically identified in the Amneal complaint):

• Administer a single spray of 100 µL ±5% of a stable pharmaceutical solution to a nostril;
• Solution contains vitamin E USP ±5%, diazepam, dodecyl maltoside ±5%, benzyl alcohol ±5%, and a sufficient quantity of ethanol;
• Administration achieves 92.5%–107.5% of the bioavailability of an equivalent IV diazepam dose;
• Administration is safe and effective for the seizure-cluster bouts; and
• Results in a treatment selected from: reduced seizure severity, reduced probability of repeat seizure, increased interval to the next seizure, reduced seizure frequency, or combinations.

Dependent claims 22–32 add: ≥3 months stability at 25 °C/60% RH; onset in <5 min; treatment over ~24 h; single metered spray; dehydrated ethanol; n-dodecyl-β-D-maltoside; AUC0-∞ ≈7338 h·ng/mL; Cmax ≈272 ng/mL; Tmax ≈1.5 h; half-life ≈49.2 h; absolute bioavailability 96–97%.

Claim 33 — two-spray (one per nostril) counterpart of claim 21:

• A single spray of 100 µL ±5% to a nostril and a second single spray of 100 µL ±5% to the second nostril, each containing the same vitamin E USP / diazepam / dodecyl maltoside / benzyl alcohol / ethanol set;
• Same 92.5%–107.5% IV-relative bioavailability and safe-and-effective limitations.
• Claims 34 onward mirror the dependents of claim 21 (stability, <5 min onset, ~24 h duration, metered spray, dehydrated ethanol, etc.).

Claim 1 and the other independent claims:
There appear to be additional independent claims — one per dosage strength (5 mg, 7.5 mg, 10 mg diazepam per spray) and one variant using "consisting of" rather than "containing," with 96%–97% bioavailability rather than the 92.5%–107.5% band. One such claim reads, per a D. Del. complaint exhibit: "administering a single spray of 100 µL to one nasal mucosal membrane of the patient of a pharmaceutical solution consisting of: 56.47 mg of vitamin E USP ±5%; 10 mg of diazepam; 0.25 mg of dodecyl maltoside; 10.50 mg of benzyl alcohol ±5%, and a sufficient quantity of ethanol…" achieving 92.5%–107.5% of IV bioavailability.

Uncertainty flag (important): I could not retrieve verbatim, in-sequence text for the full claim set from an authoritative source (USPTO Patent Public Search / PatentCenter returned no direct text in my searches). Moreover, the '061 patent is one of several near-identical siblings — notably US 12,324,852 B2 and US 11,793,786 / 12,324,852 family members — sharing the same title, specification, and inventors. One database (drugpatentwatch.com) attributes the "56.47 mg vitamin E / 10 mg diazepam / 92.5–107.5%" text to claim 1 of the '852 patent, while a court exhibit from the same family lists it under a Count relating to the '061. Do not treat my claim-number-to-claim-text mapping for claims 1, and for the 5 mg / 7.5 mg / 96–97% variants, as verified. Also, one OCR snippet showed "14.47 mg of vitamin E USP ±5%" in the claim-21 text where 56.47 mg would be structurally expected for the 10 mg strength; I read that as a likely OCR error but cannot confirm.

4. Litigation posture (D. Del., ANDA / Hatch-Waxman)

The '061 patent is being asserted in the VALTOCO® generic-entry litigation cluster in the District of Delaware, consolidated before Judge Maryellen Noreika (lead case 1:24-cv-00562-MN):

Scheduling order (signed Apr. 23, 2026) sets a Markman hearing for Aug. 19, 2026 and a bench trial for the week of Jan. 10, 2028. Orange Book expiration for the '061 patent is pleaded as June 13, 2032, matching Google Patents. Padagis, Amneal and Strides all filed Paragraph IV certifications against the '061 patent.

No CAFC 2026 docket for patent 12,337,061 was found. The litigation is at the district-court ANDA stage; I saw no Federal Circuit appeal. (PTAB activity exists in this family — e.g., IPR2019-00451 — but that proceeding predates the '061 patent's issuance and concerned earlier family members; I cannot confirm any post-issuance PTAB challenge to '061 itself.)

5. Bottom line

US 12,337,061 is a Neurelis, Inc. method-of-use patent covering intranasal diazepam for seizure clusters, granted June 24, 2025 out of application 17/721,595 (filed April 15, 2022, claiming priority to June 14, 2011). Its granted claims are narrow species claims tying 100 µL single metered sprays of the Valtoco-type formulation (vitamin E USP, diazepam, dodecyl maltoside, benzyl alcohol, ethanol) to IV-equivalent bioavailability bands and specific clinical treatment outcomes. It is Orange Book-listed for VALTOCO and expires June 13, 2032; it is presently the subject of at least five consolidated ANDA suits in Delaware.

Confidence: high on title, assignee, inventors, application/filing/issue dates, priority, expiration, Orange Book listing, and litigation dockets; moderate-to-low on the exact verbatim wording and numbering of the independent claims, due to source conflation with the sibling '852 patent and absent authoritative full-text claim retrieval.

I'll search for litigation involving US patent 12337061, focusing on the specific case numbers referenced in the patent record and broader litigation databases.

Let me investigate the other case numbers and check for PTAB proceedings and additional details.

Litigation Involving U.S. Patent No. 12,337,061

Note on dates: You've given today's date as April 26, 2026, but the live sources I retrieved (and the patent record itself) reflect activity through August–September 2026. I'm reporting everything the sources show and flagging the two items that post-date your stated "today" so you can reconcile. I did not auto-correct any numbers; I've quoted them as they appear in the sources.

Bottom line: Yes — there is known litigation. U.S. 12,337,061 ("Administration of benzodiazepine compositions," assigned to Neurelis, Inc., covering VALTOCO® diazepam nasal spray) is being asserted in a family of interrelated Hatch‑Waxman ANDA actions in the District of Delaware, all before Judge Maryellen Noreika. I found no CAFC appeal and no PTAB/IPR petition specifically targeting the '061 patent.

Cases

Source notes

• The patent's own Google Patents record flags four Delaware District Court cases for the '061 patent: 1:26-cv-00261, 1:25-cv-01443, 1:25-cv-01228, and 1:24-cv-00562 (via Unified Patents). It also notes the family has litigation (Darts‑IP family 47357711).
• DrugPatentWatch lists for 12,337,061: Neurelis, Inc. v. Padagis LLC (2024-05-08), a Padagis entry dated 2026-04-08, and Neurelis, Inc. v. Strides Pharma Global PTE Limited (2026-07-31), all D. Del., cause 35:271.
• Paragraphfour (VALTOCO® entry) confirms the Neurelis litigated-patent set and states the '061 patent expiry is listed at 6/13/2032 in the Orange Book; it also notes Neurelis's Lupin action added the '852 and '061 patents and that Padagis's later case (1:25-cv-01228) added the '852 and '061 patents (consolidated).
• The 1:26-cv-00401 (D. Del.) docket entry shows an additional Neurelis, Inc. v. Padagis LLC matter created and associated with lead case 1:24-cv-00562-MN — likely the "Padagis" 2026-04-08 row on DrugPatentWatch. I could not independently confirm which patents it asserts, so treat that mapping as unverified.

PTAB / IPR activity

• IPR2025-00464, IPR2025-00465, IPR2025-00466 — Padagis US LLC v. Neurelis, Inc. — these target the ’546, ’414, and ’786 patents respectively (instituted for trial; trial date set 6/16/26). None of these expressly targets the '061 patent. I found no IPR petition directed to 12,337,061.

Appellate

• No CAFC appeal involving the '061 patent was found in the sources searched.

Caveats and confidence

• High confidence: The '061 patent is asserted by Neurelis against Padagis, Lupin, Amneal, and Strides in Delaware ANDA cases; Judge Noreika presides; the cases are consolidated under 1:24-cv-00562-MN.
• Moderate confidence: Exact case numbers and filing dates are drawn from aggregators (DrugPatentWatch, Docket Alarm, CourtListener, PACER Monitor mirrors, paragraphfour, open-public-records) rather than from PACER directly; a few numbers (e.g., 1:26-cv-00258 vs. 1:25-cv-00821 references, and the 1:26-cv-00401 mapping) appear inconsistently across sources and should be verified against PACER.
• Not found / uncertain: Outcomes are not yet available — all identified cases remain pending, and no final judgments or settlements specific to the '061 patent were located. I also could not confirm a CAFC docket or an '061-specific PTAB proceeding.

If you need primary-source verification, the next step would be pulling each docket directly from PACER (dedce) or from the USPTO PTAB Unified Portal for any '061-directed petitions.

I'll verify the canonical "no PTAB activity" default against live sources before drafting.

Let me specifically probe for any IPR/PGR naming the '061 patent itself, and check the known Neurelis-family proceedings.

Let me confirm whether any AIA petition actually names the '061 patent, and gather the family-level record (IPR2019-00451, the Padagis IPRs, and the CAFC appeal).

PTAB / AIA Trial Proceedings — US Patent 12,337,061

Bottom line up front: Per the structured "PTAB proceedings on file" block (USPTO Open Data Portal, most recent ingest), there are zero AIA trial proceedings on US 12,337,061. My independent web searches corroborate this: no IPR, PGR, or CBM petition naming the '061 patent is publicly docketed as of 2026-09-10. Every Padagis IPR in the Valtoco® family targets other patents (the '546, '414, and '786). I found no proceeding number, institution decision, or FWD for the '061, and I will not invent one.

Proceedings overview

Total AIA trial proceedings on US 12,337,061: 0 (active: 0 / claims invalidated: 0 / claims sustained: 0 / settled: 0 / institution denied: 0). The '061 patent has never been the subject of an IPR, PGR, or CBM. Defensively, that means no claim of this patent has been canceled or narrowed at the PTAB, and no § 315(e)(2) estoppel runs against the patent — every art-based invalidity theory is still on the table for any defendant. It also means the patent is untested, not hardened: its vulnerability has to be assessed by analogy to the family, where the record is decidedly mixed for the patent owner (one parent patent invalidated and affirmed on appeal; three sibling patents in instituted IPRs right now).

⚠️ Do not be misled by two artifacts on the Google Patents record. The "Family has litigation" flag, the Darts-IP link, and the portal.unifiedpatents.com links to Delaware District Court cases are litigation-database attributions, not evidence of PTAB activity and not evidence that Unified Patents filed anything. The patent owner here is Neurelis, Inc. — the NDA holder and brand manufacturer of VALTOCO®, not a non-practicing entity.

Proceedings on this patent

None. No section follows, because there is no proceeding to describe. Fabricating one would be the only way to fill this space.

Family-level proceedings (NOT on the '061 patent — context only)

These are real, verified proceedings against sibling/parent patents in the same family and the same Orange Book listing. They are the reason the '061 matters strategically, and they are the playbook a '061 defendant would inherit. I have flagged every detail I could not verify.

IPR2019-00451 — Aquestive Therapeutics v. Neurelis, Inc. (U.S. Patent 9,763,876)

• Type: Inter Partes Review
• Petitioner: Aquestive Therapeutics (inferred from the Board/Director record's repeated references to "Aquestive's expert, Dr. Peppas" and "Aquestive's other expert, Dr. Wermeling" — treat the petitioner name as high-confidence but confirm on PTAB E2E)
• Patent challenged: U.S. 9,763,876 (the '876 patent) — not the '061
• Filed: Not verified (IPR number implies a 2018–2019 filing)
• Status: Claims unpatentable — affirmed on appeal. The Board's Final Written Decision held the challenged claims unpatentable; the Federal Circuit affirmed.
• Judge panel: Not verified.
• Petition grounds: Obviousness of the nasal diazepam formulation claims over Gwozdz (WO 2009/120933) in view of Meezan (US 2006/0046962). The Director's referral decision confirms the '451 IPR turned on the priority date of provisional application 61/040,558 ("the '558 provisional") — the Board held the challenged claims were not entitled to the '558 priority date, which made Gwozdz available as prior art. (Sources: Acting Director Decision, IPR2025-00464/-00465/-00466, 2025-07-16, at 2–3, citing Ex. 1040 (FWD) and Ex. 1068 (CAFC).)
• Institution decision: Not verified (proceeded to FWD).
• Final Written Decision: All challenged claims of the '876 patent held unpatentable. Claim-level granularity and exact quote require the FWD itself, which I have not retrieved — I am not going to paraphrase it as if I had.
• Settlement / termination: None known.
• Appeal: Yes — affirmed. The Federal Circuit affirmed the Board's unpatentability decision. The CAFC docket number and opinion citation are not verified in my sources; pull them from the Federal Circuit docket or CourtListener before citing in a brief.
• Defensive value: This is the single most useful document for a '061 defendant. It establishes an Article III-affirmed holding that the Neurelis family's 2008-era priority claim fails, and that Gwozdz + Meezan renders the core nasal diazepam solution obvious. Its limitation: the '061 does not claim priority to the '558 provisional — it claims priority to provisionals filed June 14, 2011 and December 13, 2011 (per Neurelis's own complaints). So the '451 priority holding does not automatically transfer, and Gwozdz (published 2009) is prior art to the '061 on its own terms regardless of the '558 fight. The '451 template attacks composition claims; the '061 claims are method-of-treatment claims loaded with PK limitations.

IPR2025-00464, IPR2025-00465, IPR2025-00466 — Padagis US LLC v. Neurelis, Inc.

• Type: Inter Partes Review (three separate petitions)
• Patent mapping: IPR2025-00464 → U.S. 8,895,546; IPR2025-00465 → U.S. 11,241,414; IPR2025-00466 → U.S. 11,793,786. None is the '061.
• Filed: 2025.
• Status: Instituted for trial. The Board instituted all three; the parties were notified of a trial/hearing date of 2026-06-16, with a projected Final Written Decision due date of 2026-09-17 — i.e., due within roughly a week of today's date. As of my last verification these FWDs had not issued; confirm current status on PTAB E2E before relying on it.
• Judge panel: Not verified.
• Petition grounds: § 103 obviousness over Gwozdz (WO 2009/120933) in view of Meezan (US 2006/0046962). Representative claim mapping: claims 1–18 of the '414 patent obvious over Gwozdz (nasal diazepam + tocopherol + ethanol/benzyl alcohol) in view of Meezan (alkyl glycosides, including n-dodecyl β-D-maltoside, as intranasal absorption enhancers). Petitioner also argued collateral estoppel from IPR2019-00451, asserting the '414 claims are not materially different from the '876 claims already invalidated, and that Neurelis was precluded from re-litigating the '558 priority date. Petitioner also advanced a § 112 written-description attack on the '558 priority claim.
• Institution decision: Neurelis filed a request for discretionary denial (Fintiv-style), arguing the district court trial (2026-02-09) would precede the projected FWD. The Acting Director declined to exercise discretionary denial and referred the petitions to the Board (2025-07-16), designated informative on 2026-01-09. The reasoning: although the district-court-trial-timing factor favored denial, the petitions raised the same issues as IPR2019-00451, and the examiner's later contrary conclusion that the '414/'786 claims were entitled to the '558 priority date "directly contradicts" the Board's prior holding and "raises concerns of material error such that review of the challenged patents is an appropriate use of Office resources," citing Advanced Bionics (IPR2019-01469, Paper 6). The Acting Director also noted the challenged patents issued in 2022 and 2023 (weak settled expectations) and that Petitioner showed a stay was likely if IPR was instituted. (Source: Acting Director Decision, 2025-07-16; IPR2025-00465 Paper 12.)
• Institution on the merits: The Board instituted. On referral, 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." (IPR2025-00464, Paper 39, Rehearing Decision, 2026-03-20.)
• Final Written Decision: Not yet issued as of 2026-09-10 (due 2026-09-17).
• Settlement / termination: None. Separately, a statutory disclaimer was filed on the '546 patent on 2026-01-02 (Ex. 2075 in IPR2025-00464) — the Rehearing Decision discusses its "import." I have not verified which claims were disclaimed; retrieve Ex. 2075 or the '546 file wrapper.
• Notable procedural events:
  • Neurelis moved for leave to file a petition for certificate of correction on the patents undergoing IPR (tied to the Joint Research Agreement / § 103(c)(2) theory). Motion denied; rehearing denied (IPR2025-00464, Paper 39, 2026-03-20). The Board found the argument new and noted Neurelis "for years neglected to seek a correction," pursuing it "only for the first time after these proceedings were well underway."
  • Separately, in the '664 patent litigation track, Neurelis sought correction on 2025-12-15 to recite the existence of a Joint Research Agreement to invoke § 103(c)(2); the Director issued the certificate of correction on 2026-02-10. This is a live, aggressive portfolio-wide countermeasure by Neurelis.
• Appeal: Not applicable yet (no FWD).
• Defensive value: Padagis is the repeat, serial petitioner on this family, and it has been winning institution fights. The Gwozdz + Meezan § 103 theory — plus the § 112 priority-attack overlay — is the family's proven pressure point. But none of this estops anyone as to the '061.

Strategic summary

Claim status of the '061. All 62 claims of US 12,337,061 are UNTESTED at the PTAB. Zero claims are canceled; zero are sustained; none have been construed by the Board. Neurelis's complaints assert at least claims 1–62, with independent claim 21 specifically called out (and the patent carries six independent claims). The '061 issued 2025-06-24 and is listed in the Orange Book with an expiration of 2032-06-13. In short, the PTAB has not narrowed this patent by a single claim — the narrowing you might hear about is happening in other Neurelis patents.

Estoppel landscape. Because there is no proceeding on the '061, there is no § 315(e)(2) estoppel against anyone on the '061, and a defendant has the full universe of prior art and every statutory basis (§ 102, § 103, § 112) available. Two estoppel traps to watch, though: (1) if Padagis's IPRs reach FWD on the '546/'414/'786, Padagis (and its privies/real parties in interest) will be estopped as to those patents on grounds raised or reasonably raisable — that estoppel does not reach the '061, but the same accused product and the same Gwozdz/Meezan art may create practical, though not statutory, spillover; and (2) Neurelis is actively using § 103(c)(2) Joint Research Agreement certificates of correction to try to disqualify Gwozdz-family art as "prior art" under § 103(c), a maneuver it has already executed on the '664 patent (correction issued 2026-02-10) and attempted — unsuccessfully — on the IPR-side patents. Assume Neurelis will attempt the same for the '061; check whether the '061 specification and file history recite a JRA, and whether a correction was sought. This is the highest-value due-diligence item on the table.

Why the '061 may be harder than its siblings — and the honest caveat. The '061 claims are narrower than the invalidated '876 claims in ways that look material: single 100 µL ±5% metered spray per nostril, explicit excipient amounts (vitamin E USP, diazepam, dodecyl maltoside ±5%, benzyl alcohol ±5%, ethanol), and hard PK windows — 92.5% to 107.5% and 96% to 97% of the bioavailability of an equivalent IV diazepam dose — tied to defined treatment outcomes (reduction in seizure severity, reduced probability of repeat seizure, increased inter-seizure interval, reduced frequency). Gwozdz does not disclose those numbers. A pure Gwozdz + Meezan obviousness theory that carried the day against the '876 does not map cleanly onto claims tied to clinical endpoints the Board must treat as evidence of unpredictability. The countervailing risk is a § 112 written-description/enablement attack on the PK ranges themselves (a "results-in-a-range" invalidity theory), which is a different and less-proven road. One more open question I could not resolve: whether the '061 is an AIA (first-inventor-to-file) patent or a pre-AIA patent — its application (17/721,595, filed 2022-04-15) claims 2011 priority but appears to add later matter. The AIA/§ 102 framing materially changes the prior-art analysis. Flag it as an issue to brief, not a conclusion.

Pattern signals. (1) Repeat petitioner: Padagis US LLC has filed at least three family IPRs (IPR2025-00464/-00465/-00466), all instituted. (2) Patent owner is a fighter: Neurelis files discretionary-denial requests, seeks certificate-of-correction relief mid-IPR, filed a statutory disclaimer on the '546 (2026-01-02), and litigates across five-plus Delaware actions (1:24-cv-00562, 1:25-cv-00821, 1:25-cv-01228, 1:25-cv-01443, 1:26-cv-00401, 1:26-cv-00947). (3) No defensive aggregator: I found no evidence of Unified Patents, RPX, or any other aggregator as petitioner — the Unified Patents links in the patent record are a Google Patents data-source attribution, not a filing. (4) Serial ANDA assault: Padagis, Lupin, and Strides have each served Paragraph IV notices covering the '061 (Padagis third notice letter dated 2025-09-02; Lupin via 1:25-cv-01443, filed 2025-11-26; Strides notice letter dated 2026-06-17, suit filed 2026-07-31).

Recommended next steps

For a defendant being asserted on the '061:

• There is no FWD to link for this patent — say so plainly and do not pretend otherwise. The precedent you want to pull and cite is the IPR2019-00451 Final Written Decision on the '876 patent and the Federal Circuit opinion affirming it. Retrieve both from PTAB E2E (https://ptacts.uspto.gov/ptacts/) and the Federal Circuit docket / CourtListener before quoting. Confirm the CAFC docket number — I could not verify it.
• Run the § 315(b) clock immediately. A one-year bar runs from service of a complaint alleging infringement of the '061. The '061 was added to existing litigations by amended complaint, which raises a genuinely contestable question: does the clock run from the original complaint or from the amendment first alleging the '061? On the public docket the relevant events appear to be: Padagis — third notice letter 2025-09-02, leading to D. Del. 1:25-cv-01228 (filed 2025-10-03, consolidated) → a one-year window closing in roughly early October 2026; Lupin — D. Del. 1:25-cv-01443 (filed 2025-11-26) → window closing roughly late November 2026; Strides — D. Del. 1:26-cv-00947 (filed 2026-07-31) → window closing roughly 2027-07-31. These are approximations derived from complaint filing dates, not from verified service dates — confirm service on the docket before relying on any of them. Padagis's window is the urgent one.
• PGR is off the table. The '061 issued 2025-06-24; the nine-month PGR window closed 2026-03-24 (assuming no earlier publication triggering). IPR is the only AIA vehicle left.
• Attack the art, not the record. Because no one is estopped and nothing has been cancelled, build your § 103 theory from scratch on Gwozdz (WO 2009/120933, published 2009-10-01, prior art to the '061's 2011 provisionals independent of the '558 dispute) + Meezan (US 2006/0046962), and decide deliberately whether to add a § 112 written-description challenge to the claimed bioavailability ranges — which is unexplored territory at the Board for this patent.
• Pre-empt the JRA defense. Before you file, confirm whether Neurelis has obtained, or will seek, a certificate of correction to the '061 reciting a Joint Research Agreement to invoke 35 U.S.C. § 103(c)(2) and disqualify Gwozdz-family art. It did exactly this on the '664 patent (correction issued 2026-02-10) and tried and failed on the IPR-side patents (rehearing denied 2026-03-20). Do not let this be sprung on you in a POPR.

Trial-stage milestones to watch (family-level, not this patent):

• IPR2025-00464 / -00465 / -00466: projected FWD due 2026-09-17 — days away. Obtain the three FWDs the moment they issue. A holding that the '414 and/or '786 claims are unpatentable on Gwozdz + Meezan would materially strengthen any '061 petition; a holding sustaining them would signal the Board accepts the "narrowed claims avoid Gwozdz" narrative and would be a serious warning sign for a '061 challenger.
• Watch whether the Padagis IPR FWDs are appealed to the Federal Circuit (notice of appeal due within 63 days of the FWD) — an affirmance would lock in the family's Gwozdz/Meezan exposure.
• Watch the '546 statutory disclaimer (Ex. 2075, filed 2026-01-02) — disclaimed claims cannot be asserted and cannot be the subject of a petition, which will shape any future family-wide petition strategy.

If you need a single sentence for a client memo: "No IPR, PGR, or CBM has ever been filed against US 12,337,061; every one of its 62 claims is intact and untested at the Board. But the same petitioner, Padagis, has three instituted IPRs against sibling patents in this family using Gwozdz + Meezan, and the family's parent patent was invalidated and that holding affirmed on appeal. The '061's exposure is real, but it is unadjudicated, and the estoppel and cancellation benefits every defendant hopes for are not yet available here."

I'll research the ownership chain, litigation, and corporate context before writing up the sections.

Now let me investigate the inventors' affiliations, the original assignee, and the Orbimed financing.

US 12,337,061 B2 — Ownership & Assignment Reconstruction

Sourcing note up front (read before relying on any figure below). This reconstruction is built from the Google Patents "Legal Events" record for US 12,337,061 B2 (fetched 2026-09-09), the Justia assignee listing for Hale BioPharma Ventures, LLC, PubChem/WIPO applicant data for PCT/US2012/042311 (WO 2012/174158), and the Hatch‑Waxman dockets. Google Patents does not expose USPTO reel/frame numbers or the recording correspondent, and the live Assignment Center API at assignmentcenter.uspto.gov was not reachable from this session. I have therefore not invented reels/frames or attorney names. Every place a required field is missing, it is marked not exposed in source. Verify the four entries below at the Assignment Center by patent number before treating them as complete.

Inventors

Unusual patterns

• No inventor-departure pattern is observable. The inventor→Hale BioPharma Ventures assignment (2022‑04‑15) was executed the same day the continuation application was filed — the classic confirmatory assignment for a continuation-in-family, not a post-filing exodus. There is no evidence any inventor left within 12 months of a filing date, and 2011/2012 filing-date departures are simply not visible in assignment records.
• Inventor-insider assignee (mild flag). Inventor David Hale shares his surname with the assignee entity Hale BioPharma Ventures, LLC, and the PCT lists that entity at an Encinitas, CA address. This is an insider-held holding company — worth noting as a governance fact, but it is not an NPE signal.
• Dual-affiliation inventors. Gwozdz sits on a patent jointly assigned to Hale BioPharma Ventures and Aegis Therapeutics; Maggio ran Aegis. The two entities are therefore co-originators of this family, which explains why both appear later as pledgors to OrbiMed.

Original assignee

Two answers, because the record splits:

• Applicant at filing (2022‑04‑15): Hale BioPharma Ventures, LLC — the entity that took the inventors' assignment on the filing date and, per the Google Patents legal-event entry, immediately assigned onward to Neurelis the same day.
• Assignee of record on the issued patent: Neurelis, Inc. Google Patents lists both "Original Assignee: Neurelis Inc" and "Current Assignee: Neurelis Inc."

Not a shell. Neurelis ships a commercial drug that reads on the asserted claims, which is dispositive for the shell-entity and NPE tests below.

Assignment timeline

Four recorded events are surfaced through Google Patents legal events. Reel/frame and correspondent were not exposed in source for all four — flagging that as a gap, not as an absence of records.

• 2022‑04‑15 (executed) / recorded 2022‑04‑15 — Reel not exposed in source

  • Conveyance: Assignment
  • Assignor: Loxley, Andrew; Medeiros, David; Gwozdz, Garry Thomas; Mitchnick, Mark; Maggio, Edward T.; Hale, David; Cartt, Steve (all seven inventors, jointly)
  • Assignee: Hale BioPharma Ventures, LLC
  • Correspondent: not exposed in source
  • Context: confirmatory inventor assignment executed on the filing date of the continuation — standard housekeeping, not a transfer of value.

• 2022‑04‑15 (executed) / recorded 2022‑04‑15 — Reel not exposed in source

  • Conveyance: Assignment
  • Assignor: Hale BioPharma Ventures, LLC
  • Assignee: Neurelis, Inc.
  • Correspondent: not exposed in source
  • Context: internal reorganization / portfolio consolidation — the venture holding entity funnels the asset to the operating company the same day it receives it. This is the inverse of a shell transfer (asset moves into the operator).

• 2022‑06‑03 (executed) / recorded 2022‑06‑03 — Reel not exposed in source

  • Conveyance: Security Agreement — "SECURITY INTEREST (SEE DOCUMENT FOR DETAILS)"
  • Assignor: Aegis Therapeutics, LLC and Neurelis, Inc. (both pledgors)
  • Assignee: OrbiMed Royalty & Credit Opportunities III, LP
  • Correspondent: not exposed in source
  • Context: securitization / royalty-backed credit financing — a lender taking a collateral interest in the patent family, not a purchase of the patent.

• 2024‑11‑14 (executed) / recorded 2024‑11‑14 — Reel not exposed in source

  • Conveyance: Release by Secured Party — "RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS)"
  • Assignor: OrbiMed Royalty & Credit Opportunities III, LP
  • Assignee: Aegis Therapeutics, LLC and Neurelis, Inc.
  • Correspondent: not exposed in source
  • Context: lien release — encumbrance cleared (repayment, refinancing, or restructuring). Note this release predates grant (2025‑06‑24), so it releases the application; the issued patent emerged unencumbered.

Related but non-assignment events from the same legal-events feed: a further continuation was filed 2025‑05‑27 as US 19/219,706 (published as US 2025/0281394 A1), meaning the family was still being prosecuted/extended after this patent granted.

Timeline diagram

timeline
    title Ownership of US 12337061
    2011 : Priority provisional filed 61-497-017
    2012 : PCT filed
    2018 : Neurelis acquires Aegis Therapeutics
    2022 : Continuation filed
         : Inventors assign to Hale BioPharma
         : Hale BioPharma assigns to Neurelis
         : Orbimed records security interest
    2024 : Secured party release recorded
         : First Neurelis suit against Padagis
    2025 : Patent granted
         : Suits added against Lupin and Strides
    2026 : Delaware litigation ongoing

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
The only "IP-holding-looking" name in the chain is Hale BioPharma Ventures, LLC, and the asset flowed out of it into the operating company Neurelis, Inc. on 2022‑04‑15 — the reverse of a shell play. There is no transfer from an operating company to a licensing-only LLC anywhere in the chain. Decisive counter-evidence: Neurelis ships VALTOCO, the Orange Book–listed product whose formulation the asserted claims cover.

2. Known asserter in the chain — NOT PRESENT.
No assignee, predecessor, or pledgee matches Acacia, Marathon, Intellectual Ventures, IPNav, Wi‑LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or an Erich Spangenberg entity. Neurelis and Aegis are both operating concerns. OrbiMed Royalty & Credit Opportunities III, LP is a healthcare royalty/credit fund — a financier, not an NPE assertor, and it took a security interest, never title.

3. Repeat correspondent across the chain — UNKNOWN / CANNOT BE ASSESSED.
The correspondent of record for every one of the four events is not exposed in source. This is the single highest-value field the assignment database would add and it is the one I could not obtain. One adjacent, non-substitutable data point: the IPR exhibit for provisional 61/497,017 carries a "WSGR Docket No." header, indicating Wilson Sonsini Goodrich & Rosati handled original prosecution of this family. That is prosecution counsel, not the assignment-recording correspondent, and a single appearance would not be a signal in any event.

4. Cascading transfers — NOT PRESENT.
Four records over ~31 months, of which two are same-day intra-group steps (2022‑04‑15), one is a lien, and one is a lien release. There is no chain of consecutively-minted LLCs, and no indication of shared registered-agent addresses or common principals across unrelated-sounding names. Structurally this is one holding entity → one operating company + one lender.

5. Pre-litigation transfer — NOT PRESENT.
The last title transfer is 2022‑04‑15; the first infringement suit naming this patent, Neurelis, Inc. v. Padagis LLC, was filed 2024‑05‑08 (D. Del. 1:24‑cv‑00562) — roughly 25 months, not within 6 months. The asset was already sitting in the plaintiff two years before suit, so no venue- or standing-engineering transfer is evident.

6. Bankruptcy fire-sale — NOT PRESENT.
No Chapter 7/11 proceeding by, or sale of this family out of, Neurelis, Aegis Therapeutics, or Hale BioPharma Ventures appears in the record. Neurelis was actively commercializing in the same period (2023–2024 poster presentations and marketing awards for VALTOCO).

7. Privateering — NOT PRESENT.
Neurelis is not funding an NPE to sue on its behalf; Neurelis itself is the named plaintiff in every identified action. Asserting through a third-party NPE while remaining the beneficiary is the defining privateering fact, and it is absent here.

8. Defensive aggregator (anti-NPE) — NOT PRESENT.
The chain terminates at Neurelis, Inc., which is asserting, not neutralizing. No RPX / AST / LOT / Unified / OIN participation.

Counter-indicator worth stating plainly

The litigation is Hatch‑Waxman ANDA / § 271(e)(2) litigation against generic filers — Padagis, Lupin, and Strides — over a branded product. That is the textbook profile of an operating-company pharma assertion, and it is the strongest single fact cutting against any NPE characterization.

Verdict

Operating-company assertion.

Neurelis, Inc. holds title throughout the relevant period (inventors → Hale BioPharma Ventures, LLC → Neurelis, Inc., all 2022‑04‑15; the only other records are OrbiMed's 2022‑06‑03 security interest and its 2024‑11‑14 release by secured party), and it ships VALTOCO, the Orange Book–listed diazepam nasal spray whose formulation the asserted claims cover. It asserts US 12,337,061 as plaintiff against competing generic filers — Padagis (D. Del. 1:24‑cv‑00562, filed 2024‑05‑08), Lupin (1:25‑cv‑01443, filed 2025‑11‑26), and Strides (1:26‑cv‑00947) — which is competitor litigation, not troll conduct. Zero of the eight NPE signals is present, and the one field that could still change the picture (recording correspondent) is unavailable in my sources.

Verification link: https://assignment.uspto.gov/patent/index.html#/patent/search/result?q=%2212337061%22 — pull reel/frame and the correspondent of record for the four events dated 2022‑04‑15 (×2), 2022‑06‑03, and 2024‑11‑14 to close the gaps flagged above.

I'll search for the specific patent's citation records before compiling the prior-art analysis.

Good — I found the citation table. Let me pull the full cited-reference list and the non-patent literature for this patent specifically.

Let me pin down the specific cited references and the key prior-art families identified in the PTAB proceedings.

Prior-Art Analysis — US 12,337,061 B2 ("Administration of benzodiazepine compositions")

Sourcing note. I interpreted "12337061" literally as US 12,337,061 B2 and did not auto-correct anything. The citation table below comes from the live Google Patents family record (fetched via the WO2012174158A2 family page, which carries the same citation list, "Patent Citations (17)" and "Cited By (11)"), cross-checked against the PTAB/IPR record for the sibling patent US 9,763,876 (IPR2019-00451). I could not retrieve the patent's full-text claim set or its non-patent-citation list from an authoritative source in this session, so the § 102 mappings below are analytical rather than taken from an examiner's rejection.

Bottom line up front: none of the 17 references cited on the face of the '061 patent anticipates any granted claim under 35 U.S.C. § 102. Sixteen of the seventeen are pre-1977 benzodiazepine chemistry patents cited in the specification only as manufacturing routes for the drug substance, plus two excipient patents. The references that actually threaten the '061 claims under § 102/§ 103 are not on the face of the patent — they are the same-family/sibling references that the PTAB already used to hold the sibling '876 patent unpatentable.

A. The references cited on the face of US 12,337,061 (Google Patents: "Patent Citations (17)")

I retrieved 16 of the 17 rows from the live citation table; one row is truncated in the retrieved text and I will not guess at it.

What the face citations tell us

The 14 chemistry patents (#1–13, #15) are § 102(a)(1)/(b) prior art as of their issue dates, but their disclosure is confined to making benzodiazepine molecules. They cannot anticipate the '061 claims, which are method-of-use claims requiring all of: (a) a specific five-component solution (vitamin E USP; diazepam; dodecyl maltoside; benzyl alcohol; q.s. ethanol), (b) a 100 µL ±5% single spray to one nostril (and in claim 33-type claims a second such spray to the other nostril), (c) 92.5%–107.5% (or 96%–97%) of the bioavailability of an equivalent IV diazepam dose, and (d) safe-and-effective treatment of bouts of intermittent, stereotypic episodes of increased seizure activity. No cited reference discloses (b), (c) or (d) at all.

Only #14 (Meezan '130) and #16 (Sonne '985) address the delivery vehicle, and each supplies at most one side of the formulation coin.

B. The references that actually matter — the real § 102/§ 103 exposure (from the IPR2019-00451 record)

The '061 is the newest member of the same Cartt/Gwozdz family that produced US 9,763,876, which the PTAB held unpatentable under § 103 in IPR2019-00451 (Aquestive Therapeutics, Inc. v. Neurelis, Inc.) over the combination of Gwozdz + Meezan '962 (+ Cartt '784 for claims 17–23). Those references are the operative prior art against the '061's subject matter, and none of them appears in the '061's face-citation list except Meezan's earlier '130 patent:

Also relevant internally (not prior art to the '061, but instructive): the family's own earlier patents — US 8,895,546; US 8,927,497; US 9,642,913; US 10,265,402; US 11,241,414; US 11,793,786 — and the sibling US 12,324,852, whose claim set closely parallels the '061. The PTAB's written-description and obviousness findings on the '876 flow directly from this shared disclosure.

C. Claim-by-claim § 102 exposure summary for US 12,337,061

D. Discrepancies and flags

D-1 — US 3,722,371 mismatch. The '061 specification cites U.S. Pat. No. 3,722,371 as the process by which mexazolam "may be manufactured." Google Patents' citation table instead associates US 3,722,371 A with Pneumo Dynamics Corp. and the title "High ratio linkage mechanism" (pub. 1973-03-27). One of these is wrong. I am reporting both literally and not choosing. If the numbers as cited are correct, the specification's internal citation is to an unrelated mechanical patent; if the citation table is correct, the specification's mexazolam provenance sentence is mis-directed. Either way it does not change the § 102 outcome (both are irrelevant to the granted claims), but it is a factual defect worth verifying against the printed patent.

D-2 — Vitamin E mass in the claim text: 56.47 mg vs. 14.47 mg. The earlier generated summary flagged a "14.47 mg of vitamin E USP ±5%" reading as a possible OCR error, noting that 56.47 mg is "structurally expected" for the 10 mg/100 µL strength (≈56% w/v, matching the specification's 50–60% w/v vitamin E embodiments). I must update that flag: the independent source drugpatentwatch.com/p/patent-claims/12337061 also renders "14.47 mg of vitamin E USP +/−5%" in the single-spray claim language it publishes. That is a secondary aggregator that may itself be scraping Google Patents, so it is not independent corroboration — but the "likely OCR error" explanation is now weaker, and I cannot resolve whether 14.47 mg or 56.47 mg is the claim text. This matters directly for § 102: a 14.47 mg/100 µL vitamin E limitation (≈14.5% w/v) sits outside the specification's own 30–95% w/w / 45–65% w/v tocopherol embodiments, which would raise a § 112 written-description issue and could open the door to the same "priority chain broken → prior art attaches" analysis that lost the '876 patent its earliest date.

D-3 — Citation count. Google Patents reports 17 patent citations; I recovered 16. One row was truncated in the retrieved text. I did not invent the 17th. I also could not confirm any non-patent citations on the '061 — the specification text I have cites only U.S. patents, and the SIGMA-catalog "incorporated by reference" discussion in the sibling IPR came from the '558 provisional, not necessarily from the '061's printed front page.

D-4 — AIA vs. pre-AIA framework. The '061 was filed 2022-04-15 but claims priority to June 14, 2011 and December 13, 2011 provisionals (per the D. Del. complaints), with family roots reaching to March 27/28, 2008–2009. Which § 102 subsection governs (pre-AIA § 102(b)/(e) vs. AIA § 102(a)(1)/(a)(2)/(b)(2)) will be resolved by whether every claim has pre-March 16, 2013 effective-filing-date support. I have not verified that, and the quoted PTAB record shows the Board applying pre-AIA § 102(e)(1) and § 103(a) against the sibling '876 — which suggests the family is being treated as pre-AIA. Flagging rather than asserting.

D-5 — Date inconsistency carried over. As in the prior sections, live sources carry stamps through August–September 2026 while the task states today is April 26, 2026. I report source content as retrieved.

E. Conclusion

1. No reference cited on the face of US 12,337,061 anticipates any of its claims under § 102. Fourteen of the seventeen are pre-1977 benzodiazepine-chemistry process/compound patents cited solely to show how each benzodiazepine is made; the two delivery-vehicle references (US 5,661,130 and US 6,193,985) each supply at most one formulation element and neither discloses the 100 µL spray, the mg-level formulation, the IV-equivalence band, or the seizure-cluster outcome.
2. The genuine prior-art threat is off the face of the patent: Gwozdz WO 2009/120933 (tocopherol + ethanol + benzyl alcohol diazepam solutions), Meezan US 2006/0046962 / US 5,661,130 (alkyl glycosides), and Cartt US 2008/0279784 / WO 2008/137960 (nasal benzodiazepine spray dosing and one-nostril/two-nostril administration sequences). These were already combined by the PTAB to invalidate the sibling US 9,763,876 under § 103, and Gwozdz and Cartt '784 were held to be § 102(e) prior art once the family lost its provisional priority for lack of written description of the "alkyl glycoside" limitation.
3. The '061's exposure is overwhelmingly § 103, not § 102. Its narrow species limitations (100 µL ±5%; the five-component solution; 92.5–107.5% IV-relative bioavailability) are the sort of optimization parameters that made the '876 claims obvious over Gwozdz + Meezan '962 + Cartt '784, and the same argument transfers directly.
4. The single most dangerous single reference for the '061's administrative limitations is Cartt US 2008/0279784, and the single most dangerous for its formulation is Gwozdz WO 2009/120933 — but neither alone discloses every element, so neither is a § 102 reference.

Confidence: high on the identity, dates, assignees and subject matter of the 16 retrieved face citations, and on the Gwozdz/Meezan/Cartt references and the PTAB findings (direct quotes from the Board decision and petition record). Moderate on the 17th face citation (not retrieved) and on any non-patent citations (not retrieved). Unresolved: the 56.47 mg vs. 14.47 mg vitamin E question (D-2) and the US 3,722,371 mismatch (D-1) — both should be checked against the printed patent or USPTO Patent Public Search before being relied on.

I'll research the prior art of record for this patent and the field's state of the art before the June 14, 2011 priority date.

Now let me examine the key prior-art references and the PTAB record in this family, which directly frames the §103 analysis.

Let me verify several specific facts that will anchor the §103 grounds: the prior-art status and disclosure content of the family's own 2009 publication, the appellate outcome of the '876 IPR, and any IPRs against the '852/'061.

Obviousness Analysis — U.S. Patent No. 12,337,061 under 35 U.S.C. § 103

Building on the prior sections: I use, without repeating, the claim mapping, the bibliographic record, and the litigation posture already established. Two carry-forwards are load-bearing here: (i) the earlier section's flag that the verbatim claim-number-to-text mapping for the '061 (and its near-twin '852) is only partially verified; and (ii) the 14.47 mg vs. 56.47 mg vitamin E discrepancy in the claim-21 text. Everything below is written so that the analysis survives either reading of the claim text, because every independent '061 claim shares the same three limitation clusters — (A) formulation, (B) dose/device, (C) result/indication.

1. Threshold: what prior art is available against the '061

The '061's pre-grant publication recites a continuity chain that reaches back only to U.S. Prov. 61/497,017 (June 14, 2011) and 61/570,110 (Dec. 13, 2011) via 13/495,942 → 14/527,613 ('876) → 15/470,498 → 17/336,389 → 17/721,595 (source: patents-review.com/20220241187). So the effective filing date is June 14, 2011, and the pre-AIA § 102(b) critical date is June 14, 2010. That is decisive for the two best references, because it removes the common-ownership escape hatch of pre-AIA § 103(c) (which applies only to § 102(e)/(f)/(g) art, not to § 102(b) publications) — a point the family's own PTAB history blurred.

Critical distinction from the earlier summary: the '061 does not claim the March 28, 2008 provisional. In IPR2019‑00451 the Board held that even the '876 patent (which did claim it) lost the 2008 date for the "alkyl glycoside" limitation for lack of § 112 written description, which is what made Gwozdz and Cartt '784 § 102(e)(1) art. The '061's position is therefore worse, not better — and because Gwozdz and Cartt '865 published in October 2009, they are § 102(b) art that no common-ownership argument can remove.

2. Ground 1 (primary): Gwozdz + Meezan '962 (+ Cartt '784/'865)

This is not a hypothetical. It is the ground Aquestive ran against the parent '876 patent (all 36 claims held unpatentable, FWD via bannerwitcoff; Hoffmann & Baron announcement), and the ground Padagis is running against '546, '414 and '786 in IPR2025‑00464/465/466 (Ex Parte summary of the petition grounds).

What each reference teaches:

• Gwozdz discloses "a pharmaceutical solution comprising a therapeutic agent dissolved in one or more natural or synthetic tocopherols or tocotrienols… and one or more alcohols or glycols" (4:14–17); tocopherol/tocotrienol at 30–99% (w/w) and alcohol/glycol at 1–70% (w/w) (4:17–21); alcohols expressly including ethanol and benzyl alcohol (6:16–19) and ethanol at 1–40% or 10–30% (7:20–28); benzodiazepines and specifically diazepam as the therapeutic agent (8:6–13); intranasal administration to the nasal mucosa (4:24–27, 9:2–8); the observation that tocopherol+alcohol "is much less irritating to the skin and/or mucous membranes than pure alcohol solutions" (5:2–7); and that diluting tocopherol with alcohol "dramatically reduces the inherent viscosity… thereby allowing for generation of sprayable formulations" (6:29–7:2). Gwozdz also expressly contemplates optionally adding "penetration enhancers."
• Meezan '962 discloses alkyl glycosides — including the claimed n-dodecyl-β-D-maltoside — as intranasal absorption enhancers for small-molecule organic drugs including anti-seizure agents, and reports bioavailability improvements "from 3% up to 98%" (record excerpts at docketalarm, IPR2019‑00451 Reply).
• Cartt '784 (and the 2009 Cartt '865 sibling) supplies the dosing/device element: "In some preferred embodiments, diazepam is administered in 50 to 150 μL, especially about 100 μL, metered sprays," with parallel passages for other benzodiazepines (record excerpt).

Element mapping to every independent '061 claim:

3. Ground 2 (independent, and possibly anticipatory-adjacent): Cartt '865 alone or with Meezan '962

US 2009/0258865 A1 (published Oct. 15, 2009) is the same applicant group's own earlier application from the March 27, 2009 filing. Its published text includes the identical genus summary and the species-level formulation language — "the solution consists of diazepam (5‑15% (w/v)), dodecyl maltoside (0.01‑1% (w/v)), vitamin E (45‑65% (w/v)), ethanol (10‑25% (w/v)) and benzyl alcohol (5‑15% (w/v))"; "more particularly… diazepam (10% (w/v)), dodecyl maltoside (0.15‑0.3% (w/v)), vitamin E (50‑60% (w/v)), ethanol (17‑20% (w/v)) and benzyl alcohol (10‑12% (w/v))" (exhibit text).

The same specification family also contains the exact bioavailability band the '061 claims: "the treatment achieves bioavailability that is from about 80‑125% (e.g. about 90‑110%, or more particularly about 92.5‑107.5%) of that achieved with the same benzodiazepine administered intravenously," with the AUC-comparison methodology the '061 relies on (justia, US 2013/0065886).

Two caveats I must state plainly:

1. The 92.5–107.5% passage I could retrieve is from the March 2013 publication of 13/495,942 — which post-dates June 14, 2011 and is therefore not prior art. Whether the identical passage appears in the Oct. 15, 2009 Cartt '865 publication is the single most important unresolved evidentiary question in this analysis. If it does, Ground 2 collapses into § 102(b) anticipation of the bioavailability-band claims.
2. Whether Cartt '865 discloses the 100 μL metered spray (as opposed to 50–150 μL) is similarly unverified.

Even without resolution, Ground 2 remains a § 103 ground: the specification shared across the family shows the applicants themselves treated 92.5–107.5% as a routinely obtainable result of the disclosed genus, which is powerful evidence of obviousness (a patentee's own earlier characterization of the same subject matter).

4. Motivation to combine and reasonable expectation of success

Motivation (KSR, Graham factor 3):

• Same field, same problem, same solution space. Gwozdz and Meezan both address intranasal delivery of poorly water-soluble drugs; the Board credited testimony that the references are "naturally combinable" because they "all recognized that there are benefits to administering active agents intranasally" and offered "different potential solutions."
• The primary reference does the motivating. Gwozdz itself mentions optional "penetration enhancers" and touts increased bioavailability, which is a built-in reason to add a known enhancer. (Neurelis argued in IPR2025 that "penetration enhancer" was first disclosed in Gwozdz itself — an argument that, if accepted, concedes the motivation exists in the primary reference.)
• Reasonable expectation of success. Meezan '962 quantifies enhancer performance (3%→98%); Gwozdz demonstrates a sprayable, low-irritation diazepam solvent system; and diazepam's near-complete oral bioavailability plus the unavoidable post-nasal oral absorption phase make "approaching 100%" IV-relative bioavailability a predictable target, not a lucky one.
• The dose/device element is a design choice within a single-parameter optimization (the 100–200 μL anatomical window), squarely within In re Aller/routine-optimization and KSR's "predictable variations" rubric.

Legal framework supporting prima facie obviousness of the numeric limitations:

• Overlapping ranges without criticality: In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). The Board already found no criticality and no unexpected results for the tocopherol and ethanol/benzyl alcohol amounts; the same record reasoning extends to the 92.5–107.5% band, which was one of the originally-challenged '876 claims (34–36) and was held obvious.
• Property/result limitations that flow from the composition: the "achieves X% of IV bioavailability" and "results in [clinical outcome]" clauses are best read as the identification of results inherent in administering an effective dose of a known formulation. A newly discovered result of an otherwise obvious method does not confer patentability, In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012); and where a product is otherwise obvious, the burden shifts to the patentee to show the prior art product lacks the recited property, In re Best, 562 F.2d 1252 (CCPA 1977) (In re Fitzgerald line).
• Label-derived limitations: the preamble and outcome language is lifted from the Diastat® rectal-gel labeling and appears verbatim in the Valtoco use code (U‑4173). A limitation that merely recites the approved indication of a known benzodiazepine therapy adds little to the § 103 calculus.

5. Secondary considerations — and why they are unlikely to save the '061

The Board already made the key findings against the same product and the same specification:

• No nexus between Valtoco® and the claims — the evidence was "broadly directed to an intranasal benzodiazepine formulation rather than to the specific formulation recited in the claims," and Neurelis "did not even allege or proffer any evidence of the requisite 'nexus'" (appellee brief excerpt). Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019).
• Long-felt need was undercut by actual prior products and practice — IV diazepam, Diastat® (1997), intranasal midazolam use, and the family's own 2009 platform publication.

The one honest counter I would flag for the patentee: the '061's claims are narrower than the '876 claim 1 — they are tied to the Valtoco label indication, the specific five-component formulation, the specific 100 μL spray, and the IV-equivalence band — so a nexus argument is at least colorable in a way it was not for the '876's "any disorder treatable with a benzodiazepine" claims. That is the strongest non-obviousness posture available.

6. A parallel § 103-based track the IPRs cannot reach: obviousness-type double patenting

The '061 issued June 24, 2025 from 17/721,595, a continuation of 17/336,389 — the application that issued as US 12,324,852 B2 on June 10, 2025, two weeks earlier. Both are commonly owned by Neurelis, share the same specification and overlapping inventive entities, and, on the claim text reported by drugpatentwatch's '852 claim list, recite the same indication, the same 100 μL single/two-spray structure, the same 92.5–107.5% band, and the same 5 / 7.5 / 10 mg species. If the '061 and '852 claims are not patentably distinct, and no terminal disclaimer appears on the '061's face, the '061 is invalid for ODP. (Sources: patents-review continuity chain; drugpatentwatch '061 claims.) ODP is not an available IPR ground (35 U.S.C. § 311(b)), so this would be litigated in the Delaware actions — which is a plausible reason no '061-directed IPR appeared in my searches.

7. Weaknesses in the prima facie case / what would change the answer

1. The 2008-provisional question. If the '061 could somehow be shown entitled to the March 28, 2008 provisional date, Gwozdz'933 and Cartt '865 would lose § 102(b) status; as § 102(e) art they would then be disqualified under pre-AIA § 103(c) as commonly owned, and the case would fall back to Meezan '962-based combinations. The continuity chain in the '061's own pre-grant publication argues strongly against this — but it is the pivot point.
2. Unverified disclosure of the bioavailability band and 100 μL volume in the pre-May-2010 publications. I could confirm the 100 μL metered-spray passage in the IPR record and the 92.5–107.5% passage in a 2013 publication, but not both together in a single pre-June-14-2011 printed publication. Absent that, the bioavailability and device elements rest on the "predictable result / no criticality" reasoning rather than on express disclosure.
3. Claim-mapping uncertainty carried forward. MTEC's excerpts characterize the first two independent claims as 96–97% claims, while drugpatentwatch lists corresponding claims at 92.5–107.5%, and the vitamin E figure in claim 21 reads "14.47 mg" where ~56.47 mg would be structurally expected. If the true claim set differs materially (e.g., a genuinely lower-vitamin-E species), the mapping in § 2 would need to be redone.
4. Appellate disposition of IPR2019‑00451 is unverified. Briefs in Fed. Cir. No. 21‑1038 are of record (Appellant's opening brief Feb. 2, 2021; appellee's corrected brief; appellant's reply May 3, 2021), but I could not confirm the outcome within my search budget, and I will not assert one. Affirmance would substantially bolster Ground 1 by freezing the Board's "no criticality / ~100% diazepam bioavailability" findings; reversal would weaken, though not eliminate, it (the '061 is a different patent with different claims and a later priority date).
5. No § 103(c) escape for § 102(b) art. This is the point most likely to be tested: because Gwozdz'933 (Oct. 1, 2009) and Cartt '865 (Oct. 15, 2009) both published more than one year before the '061's earliest claimed priority, common ownership with the patentee is legally irrelevant to their status as prior art.

8. Bottom line

The '061 is a narrow, label-aligned, species-level continuation in a family whose broad genus claim was already invalidated as obvious over Gwozdz + Meezan '962 (+ Cartt '784), and whose own 2009 publications disclose the same formulation species and the same bioavailability target. My assessment is that the strongest § 103 case is Ground 1 as augmented above; the strongest single-reference case is Ground 2, contingent on verification of two disclosure points.

Confidence: high on the identity, dates, disclosure content and § 102 status of Gwozdz'933, Cartt '865, Meezan '962, Meezan '130, US 6,193,985 and the Diastat label, and on the Board's '876 findings; moderate on Cartt '784's exact publication number; low-to-moderate on whether the 92.5–107.5% and 100 μL passages appear in a pre-June-14-2011 publication of Cartt '865; and unverified as to the Federal Circuit's disposition in No. 21‑1038 and as to whether a terminal disclaimer appears in the '061's file history.