US 11147782

I'll search for the patent number and related docket activity.

Let me search for the claim text and any 2026 Federal Circuit activity.

Let me find the full claim set, particularly the asserted independent claim 24.

US Patent 11,147,782 B1 — Verified Summary

Important framing note up front: I searched for this specific number (11,147,782) and limited results to that number. Everything below is grounded in the patent text itself plus litigation/prosecution record excerpts I retrieved. Where I could not verify something authoritatively, I flag it.

Bibliographic data

Assignment chain of record: inventors → Jazz Pharmaceuticals, Inc. (Apr. 8, 2021) → Jazz Pharmaceuticals Ireland Limited (Apr. 9, 2021); security agreement to U.S. Bank National Association (May 5, 2021).

Continuity (as stated in the patent, "CROSS REFERENCE TO RELATED APPLICATION")

This is a continuation of 17/118,041 (filed Dec. 10, 2020, now U.S. Pat. No. 11,307,079), which is a continuation of 16/448,598 (filed Jun. 21, 2019), which is a continuation of 15/047,586 (filed Feb. 18, 2016, now U.S. Pat. No. 10,398,662), which claims priority to provisional 62/117,889 (filed Feb. 18, 2015). Google Patents additionally lists a later priority link to 18/473,935 → publication US 2024/0016770 A1.

Abstract (verbatim)

"The present application relates to GHB formulations and methods for manufacturing the same."

Plain-language overview of the disclosure

GHB (sodium oxybate, marketed as Xyrem®) has a short half-life and must normally be dosed twice nightly. The patent describes controlled/extended-release GHB formulations aimed at maintaining therapeutic blood levels (roughly 10–20 mg/L, or up to ~40 mg/L, over 5–8 hours) and enabling once-nightly dosing. The disclosure covers several technical routes:

• Drug–ion-exchange-resin complexes ("resinates"), including strong base Type 1 anion exchange resins (cholestyramine, Purolite A430MR, Duolite AP143, Dowex, Amberlite IRN78, etc.).
• Direct in-situ synthesis: loading the prodrug gamma-butyrolactone (GBL) onto hydroxide-form resin so it reacts within the bead to form GHB resinate, achieving high loading efficiency with water as the by-product.
• Loading strategies using "intermediate" anions (e.g., bicarbonate, whose affinity for the resin is lower than chloride) to maximize oxybate incorporation (targets >75%, ideally near 100%).
• Rate control via lipophilic/hydrophobic agents (e.g., sodium lauryl sulfate, docusate, stearic acid), diffusion-controlling films (PVAcetate, Eudragit RS/L100/L55/FS100, ethylcellulose, cellulose acetate, CAP, shellac), bead size and crosslink density.
• Physical dosage forms: suspensions/sachets, tablets, capsules, powders, wafers, strips; viscosity enhancers/slippants, acids, lubricants, and "supplemental anions" (citrate, glycine, amino acids from digested protein, short-chain triglycerides) to drive exchange when gut anion supply is limiting.
• The patent also posits that because the molar GHB dose (~70–100 mEq) greatly exceeds the gut's resident anion capacity (~4.6 mEq gastric chloride), release from the resinate is physiologically rate-limited by chloride secretion, which can itself be the controlled-release mechanism.

Examples include: calcium oxybate loaded onto Dowex 1X2 (33% of theoretical capacity); GBL reacted with Amberlite IRN78 (Batches B1 and B2); a large-batch dog PK example; bicarbonate-exchange and CO₂-evolution regeneration/recycle processes; and an enteric-coated soy-protein-isolate tablet example providing supplemental amino-acid anions.

Independent claims (plain language)

Claim 1 — a GHB formulation (composition claim)
A formulation of gamma-hydroxybutyrate comprising:

• a plurality of immediate release particles comprising GHB;
• a plurality of modified release particles comprising GHB;
• a viscosity enhancing agent; and
• an acid;
• wherein the viscosity enhancing agent and the acid are separate from (i.e., not contained within) the immediate release particles and the modified release particles.

Claim 14 — a unit dose (article-of-manufacture/dosage-form claim)
A unit dose comprising a GHB formulation, having the same core elements as claim 1 (plurality of immediate release particles with GHB; plurality of modified release particles with GHB; a viscosity enhancing agent; an acid; viscosity enhancing agent and acid separate from the particles).
Uncertainty flag: I could not retrieve the fully verbatim, complete text of claim 14 from an authoritative reproduction. The wording above is reconstructed from the USPTO-prosecution amendment table and litigation quotations (the CAFC appendix excerpt I retrieved truncated after claim 14's preamble). Treat claim 14's exact wording as not fully verified.

Claim 24 — the commercially operative claim
"The unit dose of claim 14, wherein the unit dose is a sachet." This is the only claim the Delaware jury found infringed (March 4, 2024 verdict: infringement of U.S. Pat. No. 11,147,782; no infringement of U.S. Pat. No. 10,758,488; damages of $234), and the claim on which the permanent injunction issued.

Dependent claims (identified from the patent reproduction retrieved):

• 2: viscosity enhancing agent selected from xanthan gum, microcrystalline cellulose, hydroxyethyl cellulose, hydroxypropylmethyl cellulose, carboxymethylcellulose sodium, hydroxypropyl cellulose, and mixtures.
• 3: acid selected from malic, citric, tartaric, boric, maleic, phosphoric, and benzoic acid.
• 4: further comprising a lubricant (magnesium stearate, stearic acid, calcium stearate, hydrogenated castor oil, hydrogenated vegetable oil, light mineral oil, mineral oil, polyethylene glycol, sodium benzoate, sodium stearyl fumarate, zinc stearate).
• 5: lubricant is magnesium stearate.
• 6: amount of GHB equivalent to 4.0 g–12.0 g sodium gamma-hydroxybutyrate.
• 7: equivalent to about 4.0 g, 6 g, 7.5 g, or 9 g.
• 8: about 6 g. 9: about 7.5 g. 10: about 9 g.
• 11: blood concentration 10 mg/L to about 40 mg/mL (units as printed) at 8 h post-administration.
• 12: blood concentration 15 mg/L to about 30 mg/mL at 8 h.
• 13: formulation is a multiparticulate composition.
• 15–18: unit-dose analogues of claims 2–5 (viscosity agent, acid, lubricant, magnesium stearate).
• 19: 15–30 mg/mL at 8 h.
• 20: equivalent to 4.0–12.0 g sodium oxybate.
• 21/22/23: about 6 g / 7.5 g / 9 g.
• 24: unit dose is a sachet.

(Claims 14–23 recitation above is consistent across the patent copy and litigation excerpts, but note the OCR of claim 11/12 in the reproduction says "mg/mL" where "mg/L" is plainly intended — I am reporting the identifier literally rather than correcting it.)

Litigation and docket status — including the "CAFC 2026" question

I searched for Federal Circuit 2026 docket activity on this patent and found none. My explicit note of uncertainty: I could not confirm the existence of any 2026 CAFC docket involving U.S. Pat. No. 11,147,782. The CAFC activity I did verify is from the 2024 term:

• CAFC Nos. 24-2274 and 24-2278 (appeals from D. Del. No. 1:21-cv-01594-GBW and related). Decided May 6, 2025 (authored by Judge Lourie, with Reyna and Taranto): reversed-in-part, vacated-in-part, and remanded. The decision addressed the permanent injunction (Aug. 27, 2024, D. Del.), reversing the parts barring Avadel from offering open-label extensions and from initiating new clinical trials, and vacating the part barring Avadel from applying for FDA approval of LUMRYZ for indications beyond narcolepsy.
• District court (D. Del.) related dockets: 1:22-cv-00487 and 1:21-cv-01594; the '782 patent was asserted in Jazz's "Third Complaint" (Nov. 10, 2021) against Avadel's LUMRYZ/FT218.
• Injunction/royalty: Aug. 27, 2024 order enjoining Avadel from infringing claim 24; Sept. 15, 2025 order setting a 3.85% ongoing royalty on LUMRYZ narcolepsy sales through expiration of the '782 patent on February 18, 2036.
• Settlement: On October 21, 2025, Avadel CNS and Jazz entered a Settlement and License Agreement; all parties filed a joint stipulation of dismissal with prejudice on Oct. 24, 2025, entered Oct. 27, 2025. Royalty rates: 3.85% for narcolepsy LUMRYZ, 10% for non-cataplexy/non-EDS indications (including idiopathic hypersomnia). Avadel also would otherwise have had a pending JMOL challenge to '782 validity and further Federal Circuit appeal contemplated, but the settlement resolved the disputes.
• Related pending/other matters referenced in SEC filings include a cross-suit by Avadel/Flamel asserting U.S. Pat. Nos. 12,167,991, 12,186,298, 12,226,388, and 12,226,389 against XYWAV, and Jazz's APA suit against FDA (D.D.C.).

If a live 2026 CAFC docket for 11,147,782 does exist, it did not surface in my searches; the most recent authoritative event I could verify is the October 2025 global settlement and dismissal.

Key verification notes / uncertainties

1. Claim 14 full text — reconstructed, not verified verbatim (see flag above).
2. No 2026 CAFC docket located — cannot confirm or deny its existence beyond what my searches returned.
3. Priority dispute: Avadel contended in district court that the '782 patent is entitled to a priority date no earlier than March 23, 2021, arguing the claims were copied from Avadel's '866 patent and lack written-description support in the 2015 specification (e.g., D.I. 357 in D. Del. 1:21-cv-00691). The jury nevertheless found the asserted claim valid; that validity holding was on appeal when the case settled. This is an allegation in litigation, not an adjudicated final fact.
4. Dates: filed 2021-03-23 and issued 2021-10-19 are corroborated by both the Google Patents record and the patent PDF cover page; note the patent is a continuation, so the 2015-02-18 date is the family priority date, not this application's filing date.

I'll research litigation involving US patent 11147782. Let me search multiple sources.

Let me search for additional details on the appeals, PTAB proceedings, and any other cases.

Litigation involving U.S. Patent No. 11,147,782 ("the '782 patent")

Bottom line: Yes — the '782 patent has been extensively litigated. All known litigation is the Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals dispute over Avadel's once‑nightly sodium oxybate product LUMRYZ™ (FT218), in the U.S. District Court for the District of Delaware, plus appeals to the Federal Circuit. The district court cases were all settled and dismissed with prejudice on October 27, 2025. I found no PTAB (IPR/PGR) proceedings against the '782 patent.

A caveat on method: I could not pull the Unified Patents litigation portal pages directly (they are rendered client‑side), so I relied on court documents (Justia/CourtListener/recap), SEC filings (Jazz, Avadel, Alkermes), DrugPatentWatch, and the litigation links printed on the Google Patents page for US11147782B1. Where a detail is uncertain I flag it.

1. The case in which the '782 patent was asserted

Jazz alleged that Avadel's NDA product (once‑nightly sodium oxybate, LUMRYZ/FT218) would infringe at least one claim of the '782 patent. Avadel timely answered and counterclaimed on January 7, 2022 (the "Third Avadel Answer"), seeking declaratory judgments of non‑infringement and invalidity/unenforceability, and later correction of inventorship.

Sources: Jazz/Alkermes and Avadel SEC disclosures (avdl-20250930, alkermes.gcs-web.com/node/23301); DrugPatentWatch docket 1:21-cv-01594; Complaint analysis of 1:21-cv-01594 ("the action arises from Defendant's NDA filing … U.S. Patent No. 11,147,782 … 'GHB formulation and method for its manufacture,' issued October 19, 2021").

2. Related Delaware cases in the same consolidated dispute

The '782 patent was litigated together with two earlier Jazz complaints under one schedule (all before Judge Gregory B. Williams), and the '782 patent's validity went to the jury:

• February 2024 patent trial (Jazz v. Avadel, D. Del.): Avadel stipulated to infringement of claim 24 of the '782 patent. On March 4, 2024, the jury returned a verdict that the '782 patent was not invalid (not for lack of written description, not for lack of enablement, and not for improper inventorship). The jury also found Avadel did not infringe U.S. Pat. No. 10,758,488 (the '488 patent).
• Post‑trial: Jazz moved for a permanent injunction and ongoing royalty. On August 27, 2024, the court permanently enjoined Avadel from seeking FDA approval of / marketing LUMRYZ for idiopathic hypersomnia, denied an injunction as to new narcolepsy patients, and granted an ongoing royalty (Jazz Pharms., Inc. v. Avadel CNS Pharms. LLC, No. 21-cv-691, 2024 WL 4005200 (D. Del. Aug. 27, 2024)).
• I note a source inconsistency: the permanent‑injunction and trial papers are captioned both in 21-cv-00691 and in the related numbers (21‑1138, 21‑1594). The three cases were coordinated/scheduled together, and the Federal Circuit appeal was taken from all three docket numbers.

Source: D. Del. Memorandum Opinion (D.I. 675 in 1:21-cv-00691, filed 09/06/24); Avadel and Jazz/Alkermes SEC disclosures; DrugPatentWatch 1:21-cv-01594 docket (listing, inter alia, the '782 patent among the patents‑in‑suit).

3. Federal Circuit appeal (the '782 patent injunction)

The Federal Circuit reversed the parts of the injunction barring Avadel from offering open‑label extensions to trial participants and from initiating new clinical trials/studies, and vacated the part barring Avadel from seeking FDA approval of LUMRYZ for any indication beyond narcolepsy. The Google Patents page for US11147782B1 lists the Federal Circuit cases as 24‑2278 and 24‑2274 (matching the above).

• On remand (2025): Jazz filed a renewed motion for a permanent injunction on June 17, 2025; Avadel opposed; the district court denied the renewed motion on September 8, 2025.

Sources: CAFC opinion (justia.com CAFC 24-2274, filed 05/06/2025); CAFC Answering Brief (recap gov.uscourts.cafc.22134); Avadel 10‑K/10‑Q disclosures; CourtListener D. Del. docket 1:21-cv-01594 (D.I. 614 renewed motion; D.I. 640 order).

4. Avadel's affirmative trade‑secrets / inventorship case (involves the '782 patent)

Avadel alleged that Jazz used Avadel confidential information to develop its own once‑nightly GHB formulation and that the inventions (including the application that matured into the '782 patent) should name Avadel scientists (Drs. Guillard and Mégret) as inventors. Jazz's motion for judgment on the pleadings was denied (July 18, 2023); the case was stayed pending the patent appeal and then settled.

This is the case identified by the Google Patents litigation link for Delaware District Court case 1:22-cv-00487 on the US11147782B1 page.

Sources: D. Del. D.I. 26 (Motion for Judgment on the Pleadings, 1:22-cv-00487); D.I. 86 (Avadel brief re: Jazz's '782 patent inventorship allegations); CourtListener dockets 63237695 and 60985221; DrugPatentWatch.

5. Antitrust case where '782 validity was litigated/narrowed (related, not the asserted patent)

Source: D. Del. Memorandum Opinion (1:22-cv-00941, May 24, 2024), discussing Jazz's motion to stay "pending final resolution of the validity of U.S. Patent No. 11,147,782."

6. Global settlement / dismissal (current status)

• October 21, 2025: Jazz and Avadel reached a global settlement.
• October 24, 2025: the parties filed a joint stipulation of dismissal with prejudice; the court entered it on October 27, 2025, terminating the Delaware actions, including 1:21-cv-00691, 1:21-cv-01138, 1:21-cv-01594, 1:22-cv-00487, 1:22-cv-00941, and the later 2025 Avadel cases (1:25-cv-00009, 1:25-cv-00057, 1:25-cv-00221).

Sources: CourtListener D. Del. D.I. 650 (1:21-cv-01594, "SO ORDERED AND ~Util - Terminate Civil Case") and D.I. 175 in 1:22-cv-00487 (Oct. 27, 2025 "SO ORDERED" terminating the civil cases); Avadel and Jazz/Alkermes SEC disclosures.

Summary table

Limitations / uncertainties

• I found no PTAB IPR or PGR involving U.S. Patent No. 11,147,782. I am stating this as "not found," not as a definitive negative — my searches did not surface any, but I did not run a full PTAB docket query.
• The Google Patents page for US11147782B1 shows only four litigation links (D. Del. 1:22-cv-00487; D. Del. 1:21-cv-01594; and Fed. Cir. 24-2278 and 24-2274). That page does not list 1:21-cv-00691 or the settlement/dismissal, so the case list above is broader than the Google Patents metadata and is drawn from the court and SEC records cited.
• Exact damages figures / royalty rates were filed under seal (the parties jointly moved to redact financial terms), so I have not stated them.
• I could not independently verify the current status of any foreign/parallel proceedings; the Google Patents page references a "first worldwide family litigation" record (Darts‑ip family 67770221), which I did not retrieve.

If you want, I can pull the actual PACER/recap dockets for 1:21-cv-01594 and the Federal Circuit consolidated appeal to confirm the precise claim‑construction, JMOL, and post‑settlement orders.

I'll verify the structured data against live sources before drafting.

Proceedings overview

Zero AIA trial proceedings are on file against US 11,147,782. The structured PTAB block drawn from the USPTO Open Data Portal returns no IPR, PGR, or CBM for this patent as of the most recent ingest, and my independent web searches for a petition, institution decision, or final written decision naming the '782 patent returned nothing — only district-court and Federal Circuit materials from Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC. Breakdown: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0.

Bottom-line defensive posture: the '782 patent has never been tested at the PTAB at all. There is no claim you can point to as canceled, and there is no IPR estoppel to inherit. What you inherit instead is the opposite of a hardened patent and the opposite of a dead one: the patent's only adjudicated validity test was a jury verdict in Delaware (February 2024) that came out for Jazz on the claim Avadel put on trial. An IPR-based defense is therefore not "foreclosed" — it is simply untried, and the Art Unit and prior art remain open ground.

Because the requested per-proceeding format presupposes proceedings that exist, I've used the slots below to document the non-PTAB challenges and appeals that are frequently mistaken for AIA activity, plus the closest historical analogues. I have not fabricated proceeding numbers.

No AIA proceeding — the '782 patent's validity fight has been 100% judicial

• Type: N/A (no Inter Partes Review / Post-Grant Review / Covered Business Method on file)
• Filed: N/A
• Status: No PTAB activity on file. The USPTO ODP AIA-trial record for US 11,147,782 is empty.
• Judge panel: N/A — no APJ panel has ever been assigned.
• Petition grounds: N/A. Note for clarity: Avadel's obviousness and § 112 attacks on the '782 patent were made in district court, and its prior inconsistent statements regarding Liang 2006 were made in ex parte prosecution of its own applications (Avadel App. No. 16/281,235, 2020-03-18 response to Office Action). Neither is an AIA petition. See Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, D. Del. No. 1:21-cv-00691-GBW, D.I. 238 ¶¶ 35–41 and D.I. 448 (Jazz's 2023-12-19 SJ brief, "Avadel's Arguments To The PTO Before This Case Began Directly Contradict Its Obviousness Arguments In This Case").
• Institution decision: N/A
• Final Written Decision: N/A. There is no FWD and therefore no claim-level PTAB disposition for the '782 patent. Do not represent otherwise to a court or an adversary.
• Settlement / termination: N/A (no proceeding to terminate)
• Appeal: N/A as to the PTAB. Important trap: Google Patents lists Federal Circuit cases 24-2274 and 24-2278 (plus 24-2277) under this patent's litigation banner. Those are appeals from the Delaware district court's permanent injunction order and stay order — not appeals from a PTAB decision. They are Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, -2277, -2278 (Fed. Cir. 2025-05-06) (precedential), in which the panel (Judge Lourie writing) held the district court abused its discretion by enjoining Avadel's Lumryz clinical trials and IH-approval efforts, vacated in relevant part, and remanded for the § 271(e)(2) question. Source: https://cases.justia.com/federal/appellate-courts/cafc/24-2274/24-2274-2025-05-06.pdf and https://storage.courtlistener.com/recap/gov.uscourts.cafc.22134/gov.uscourts.cafc.22134.35.0.pdf
• Defensive value: There is no PTAB shortcut here. A defendant must litigate validity, and the jury's February 2024 verdict on the '782 claim that was tried (claim 24) is a real headwind — but a jury verdict binds only those parties, so it is far weaker as a shield for the patent owner than a PTAB FWD sustaining claims would have been.

Historical analogues (DIFFERENT patents — cite with care)

These are the Jazz oxybate IPRs that actually happened. None of them involves US 11,147,782, and none may be cited as a proceeding "on" the '782 patent:

• IPR2015-00545, -546, -547, -548, -551, -554 — [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC) and Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc. These challenged the Xyrem distribution-system / REMS patents (including US 8,589,182, US 7,668,730, US 8,457,988). The Board issued final written decisions on 2016-07-27 holding the challenged claims unpatentable. See https://www.docketalarm.com/cases/PTAB/IPR2015-01813/.../Final_Written_Decision_IPR2015_00545.pdf and Jazz's Form 8-K dated 2016-07-27.
• IPR challenges to US 8,772,306 (the valproate drug-interaction patent) — Amneal and Par. Two petitions were denied outright; a third was instituted on a subset of claims and was then terminated after settlement. See Jazz's briefing in Jazz Pharms., Inc. v. Avadel describing this history ("In 2016, three generic manufacturers challenged the '306 patent in inter partes review … Two of the petitions were denied outright … and the third led to the institution of IPR on a subset of the challenged claims … after which the parties settled and the proceeding was terminated"), quoting RJN Exs. 24, 26, 27, 28.

Analogue value: Jazz has fought IPRs before and lost some (the REMS patents) and won some (the '306 patent survived every challenge). That cuts both ways and tells you Jazz is not an easy mark, but also that Jazz's oxybate portfolio is demonstrably not IPR-proof.

Strategic summary

Claim status on US 11,147,782: CANCELED — none. SUSTAINED — none, at the PTAB. UNTESTED at the PTAB — all of it. No claim of the '782 patent has been canceled, narrowed, or confirmed by the Board, so there is no "surviving claims" list to give you. What exists is a judicial data point: Avadel stipulated to infringement and took validity of the '782 patent to a Delaware jury in the February 2024 trial, and the jury sided with Jazz at least as to claim 24, awarding a reasonable royalty of $233,562.83. Per MLex's report of the 2025-05-06 Federal Circuit decision, "jurors sided with Jazz, upholding the claim as patentable." Avadel's expert Charman identified the asserted '782 claims as claims 1–24 (https://storage.courtlistener.com/recap/gov.uscourts.ded.75471/.../569.1_2.pdf), while sell-side and press coverage of the trial describe the disputed claim as the sachet claim (claim 24, with some sources saying "claim 25"). Treat the exact tried-claim set as something to pull from the D. Del. docket (final pretrial order / verdict form) rather than from secondary sources — the public record is inconsistent on that point and I will not paper over it.

Estoppel landscape: there is nothing to inherit, and that is the good news for a defendant. Because no IPR/PGR was ever instituted against the '782 patent, 35 U.S.C. § 315(e)(2) estoppel does not attach to anyone. No petitioner is barred from raising any § 102 or § 103 ground, and no privy of a petitioner is barred either. A new defendant can assert all prior art — including art that Jazz's own prosecution history and the Avadel litigation never surfaced in a PTAB record. The flip side: Jazz gets no § 325(e) benefit either, and there is no earlier Board construction of "modified release particles," "viscosity enhancing agent," or "acid" that would constrain the Board (the Delaware claim construction at the 2022-11-18 Markman and the later "sustained release portion" ruling are district-court acts, not Board acts). Two secondary considerations cut against filing: (1) Avadel's own judicial-estoppel/unclean-hands fight with Jazz is a warning that inconsistent PTO positions can be weaponized — the court rejected the estoppel theory (D.I. 526 at 290), but the fight cost real time and money; and (2) the USPTO's 2025-10-16 institution memorandum (Director Squires) centralizes institution in the Director and the October 2025 proposed rules would bar an IPR against a patent that had already survived a validity challenge in district court or at the PTAB, with comments due 2025-11-17 (https://www.willkie.com/publications/2025/10/ptab-announces-new-institution-policy). Whether that proposal is now final is something I cannot confirm as of 2026-10-01 — verify current rule status before you budget a petition, because a jury verdict sustaining '782 claim 24 may itself be the disqualifier under the new regime.

Pattern signals. No petitioner has ever filed against this patent, so there is no serial-filer pattern and no defensive aggregator (Unified Patents, RPX, etc.) in the chain — the Google Patents "family litigation" banner shows only district-court and CAFC entries, and the Darts-IP/Unified links point at the Jazz v. Avadel suits (D. Del. 1:21-cv-01594; CAFC 24-2274, 24-2278). Jazz has not been a PTAB appellant on this patent because it has had no need to be. One lead I could not verify and am flagging rather than asserting: Google Patents also lists Delaware 1:22-cv-00487 under this family. I do not know the parties or the patents asserted there; it is not the Avadel case numbers and should be pulled directly.

Recommended next steps

1. Do not tell a court or client that any claim of the '782 patent is canceled. On the record available, none is. There is no FWD to link to. The correct framing is "unchallenged at the PTAB; sustained by a jury on the one claim Avadel actually tried."
2. Pull the Delaware verdict form and final pretrial order from Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 1:21-cv-00691-GBW / -1138-GBW / -1594-GBW, to fix exactly which '782 claims the jury decided were valid and infringed. Secondary sources are split between claim 24 and claim 25; the D.I. 418 expert report lists asserted claims 1–24. Get this right before drafting.
3. Treat validity as open ground, not settled ground. With no § 315(e)(2) estoppel, every § 102/§ 103 ground is available. The Avadel trial record (Charman opening reports attacking enablement and written description; Klibanov's obviousness report built on Liang 2006, Lebon 2013, and Allphin 2012) is a free roadmap — see https://storage.courtlistener.com/recap/gov.uscourts.ded.77089/gov.uscourts.ded.77089.238.0.pdf and the expert report exhibits in D.I. 581. Note that Avadel's § 112 enablement and written-description theories survived summary judgment as genuine fact disputes (D.I. 526) — those are jury questions, not PTAB questions, so a PTAB petition must be built on art, not on § 112.
4. Check the non-AIA channels the ODP block does not cover. The structured data is limited to AIA trials. Before filing anything, run the '782 patent's Patent Center / reexamination and reissue tabs and the assignment record (U.S. Bank NA holds a security interest per the 2021-05-05 assignment entry) to confirm there is no ex parte reexam, supplemental examination, or reissue that would change the claim set or the real party in interest.
5. Time the filing against the current institution regime. If the October 2025 proposed rules are final in the form described, a patent that has survived a district-court validity challenge is off-limits for IPR, and institution now runs through the Director rather than a merits panel. Confirm status at https://www.uspto.gov before spending on a petition; if the bar is in force, the practical posture for a new defendant is a district-court validity case, not a PTAB one.

Verification note: the "no PTAB activity" conclusion rests on (a) the structured ODP block and (b) my searches. I found no IPR/PGR/CBM naming US 11,147,782. I did not have API-level access to PTAB E2E in this session, so if absolute certainty is required for a filing, confirm directly at https://ptacts.uspto.gov/ptacts/ (patent-number search on 11147782) before you represent the absence of proceedings as a fact.

I'll research this patent's ownership chain using the sources available to me. Let me start with several parallel searches.

Let me try to pull the specific USPTO assignment reel/frame records for this patent.

Ownership & Assignment Analysis — US 11,147,782 B1

Data-access note (read first): I attempted to pull this patent's records from the USPTO Assignment Center, but my retrieval did not return the reel/frame numbers or the correspondent-of-record fields, and I will not fabricate reel/frame identifiers. The reconstruction below is grounded in (a) the Google Patents legal-events block for US 11,147,782 and (b) the court records/SEC filings cited inline. Where a field could not be verified, it is marked [not retrieved]. The patent does have post-issuance recorded activity — this is not a "no records" case.

Inventors

Both are named on the face of the printed patent (Applicant: Jazz Pharmaceuticals Ireland Limited, Dublin (IE)). The inventors executed an assignment directly to Jazz Pharmaceuticals, Inc., recorded 2021-04-08 (Google Patents legal events: "Assignors: BURA, SCOTT, ALLPHIN, CLARK"), confirming they were Jazz personnel at filing.

Pattern notes:

• The inventorship is contested, not merely unusual. In a parallel Delaware action (Avadel CNS v. Jazz, filed 2022-04-14), Avadel sought correction of inventorship of certain Jazz oxybate patents to add former Avadel scientists and alleged trade-secret misappropriation and derivation. Avadel argued the '782 claims were "slavishly copied" from Avadel's published application. A jury returned a verdict of no improper inventorship (Fed. Cir. 2024-2274/2277/2278 record). This is a derivation/inventorship dispute — not the classic "inventors depart the assignee within 12 months → portfolio fire-sale" pattern. No evidence of inventor departure was found; mark that specific sub-signal not present.

Original assignee

Jazz Pharmaceuticals Ireland Limited (Dublin, Ireland) — named applicant and, per the front page, the assignee ("(73) Assignee: Jazz Pharmaceuticals Ireland Limited").

• Corporate context: Jazz Pharmaceuticals Ireland Ltd. is an Irish IP-holding subsidiary of Jazz Pharmaceuticals plc (NASDAQ: JAZZ). Jazz Pharmaceuticals, Inc. is the U.S. operating company (Delaware corp., 3180 Porter Drive, Palo Alto, CA — confirmed in IPR2016-00738 RPI statement).
• Products: Jazz ships Xyrem® and Xywav® (sodium oxybate / mixed oxybate salts) — validated operating pharma revenue, not a paper portfolio. In 2023 oxybate products were ~48% of Jazz revenue (D. Del. 1:21-cv-00691, OPB at p.1).
• Key nuance: the '782 patent is not Orange-Book-listed for Xyrem or Xywav; it claims a resinate/sachet unit-dose formulation. Jazz nonetheless asserted it off-Orange-Book against Avadel's competing product Lumryz.
• Status: Operating, publicly traded, solvent. No bankruptcy, no dissolution.

Assignment timeline

All three entries below are per the Google Patents legal-events block for US 11,147,782. Reel/frame and correspondent fields could not be verified from my retrieval and are marked [not retrieved].

• 2021-04-08 (executed) / recorded 2021-04-08 — Reel [not retrieved]

  • Conveyance: Assignment (inventor → company)
  • Assignor: Scott Bura; Clark Allphin
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: [not retrieved]. (Cannot assess recurrence — no correspondent data available.)
  • Context: Standard employment/inventor assignment vesting title in the U.S. operating company.

• 2021-04-09 (executed) / recorded 2021-04-09 — Reel [not retrieved]

  • Conveyance: Assignment
  • Assignor: Jazz Pharmaceuticals, Inc.
  • Assignee: Jazz Pharmaceuticals Ireland Limited
  • Correspondent: [not retrieved].
  • Context: Internal reorganization — title moved from the U.S. operating entity to the Irish group IP holder (the name printed on the patent). Same Jazz corporate family on both sides.

• 2021-05-05 (executed) / recorded 2021-05-05 — Reel [not retrieved]

  • Conveyance: Security Agreement (security interest / collateral, not a title transfer)
  • Assignor (grantor): Cavion, Inc.; Celator Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee (secured party): U.S. Bank National Association
  • Correspondent: [not retrieved].
  • Context: Securitization — the '782 patent pledged as collateral under a Jazz group credit facility. Grantors Cavion and Celator are Jazz-acquired subsidiaries (Celator acquired 2016; Cavion acquired 2019), confirming a single-company collateral package rather than any third-party transfer.

(No further assignments recorded through my data as of today. The patent remains with Jazz Pharmaceuticals Ireland Limited.)

Timeline diagram

timeline
    title Ownership of US 11147782
    2015 : Provisional filed by Jazz inventors
    2016 : Nonprovisional filed by Jazz
    2021 : Inventors assign to Jazz Inc
         : Jazz Inc assigns to Jazz Ireland
         : Security agreement with US Bank
         : Patent issued to Jazz Ireland
         : Jazz sues Avadel in Delaware
    2024 : Jury finds Avadel infringes
         : Permanent injunction entered
    2025 : Federal Circuit vacates injunction
         : Settlement and dismissal

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only assignee-to-assignee transfer (2021-04-09) runs Jazz Pharmaceuticals, Inc. → Jazz Pharmaceuticals Ireland Limited, both members of the same publicly traded Jazz group. No "IP/Holdings/Ventures" single-purpose LLC appears. The second recorded event (2021-05-05) is a Security Agreement to U.S. Bank National Association, a treasury/credit-facility pledge — not a title transfer to an assertion vehicle.

2. Known asserter in the chain — not present. No assignee matches any published NPE list (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant, Vringo, Pendrell, Round Rock, etc.). The asserting party is Jazz Pharmaceuticals, Inc./Ireland, a commercial drug manufacturer, suing a direct competitor (Avadel/Lumryz).

3. Repeat correspondent across the chain — unclear. I could not retrieve the correspondent-of-record for any of the three entries, so recurrence cannot be tested. Flagged as inconclusive, not as a negative finding.

4. Cascading transfers — not present. The nearest thing to "cascading" is the two-day internal sequence (2021-04-08 inventor→Jazz Inc.; 2021-04-09 Jazz Inc.→Jazz Ireland), which is an ordinary intra-group reorg, not chained LLCs. No shared registered-agent shell addresses are evidenced.

5. Pre-litigation transfer — not present (borderline). The first suit naming the '782 patent was filed 2021-11-10 (D. Del. 1:21-cv-01594, "Third Complaint," per Avadel SEC filings). The last title-changing assignment was 2021-04-09 — approximately 7 months before suit, outside the 6-month window. No transfer was arranged within 6 months of filing suit. (Note: the application itself was filed 2021-03-23, ~3 months after Avadel's 2020-12-15 NDA — a fast-follow prosecution tactic, but that is a filing-timing fact, not an ownership signal.)

6. Bankruptcy fire-sale — not present. No Chapter 7/11 by any assignor or assignee is in evidence. Jazz is operating and solvent.

7. Privateering — not present. Jazz asserted the patent directly against its own competitor; there is no transfer to a third-party NPE asserting on Jazz's behalf.

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT, Unified, or OIN.

Verdict

Operating-company assertion.

Jazz Pharmaceuticals Ireland Limited — an operating pharmaceutical subsidiary of NASDAQ-listed Jazz Pharmaceuticals plc — remains the owner, having acquired title by inventor assignment on 2021-04-08 and an intra-group transfer on 2021-04-09, with the patent merely pledged as collateral to U.S. Bank on 2021-05-05 (Security Agreement). Jazz then asserted the '782 patent directly against a commercial competitor (Avadel/Lumryz) in D. Del. 1:21-cv-01594, prevailing on infringement at a March 4, 2024 jury trial and obtaining an injunction (later vacated-in-part by the Fed. Cir. on 2025-05-06). Every NPE-specific signal is absent or unverifiable; this is competitor-versus-competitor pharma enforcement, not an NPE chain.

Verify at: https://assignmentcenter.uspto.gov/ (search patent 11,147,782) and https://assignment.uspto.gov/patent/index.html — to recover the reel/frame numbers and correspondent-of-record I was unable to retrieve, which are the two fields needed to fully close signal #3.

I'll research this patent and its citations. Let me run several searches.

Let me get the complete front-page reference list and the claims of US11147782.

Let me retrieve the complete front-page reference list and the actual claims of US11147782.

Prior-Art Analysis — US 11,147,782 B1

Important caveat up front: I was able to retrieve the patent's specification and its claims, and I captured the face-of-patent "References Cited" list only in partial, OCR-derived form from litigation exhibits (the full front‑page list is split across pages I could not all load, and one OCR copy garbles several numbers/dates). Wherever I am not confident of a reference's identity or content, I say so explicitly rather than filling the gap. All identifiers are reproduced literally as found (e.g., the patent is US 11,147,782 B1, application 17/210,064; I have not "corrected" anything).

1. The patent at issue

• Number: US 11,147,782 B1 — "GHB formulation and method for its manufacture"
• Inventors: Clark Allphin (Seattle, WA); Scott Bura (Gilroy, CA)
• Assignee: Jazz Pharmaceuticals Ireland Limited (Dublin, IE)
• Appl. No. 17/210,064; Filed: Mar. 23, 2021; Granted/Published: Oct. 19, 2021
• Priority chain (from the specification): 17/210,064 ← 17/118,041 (Dec. 10, 2020) ← 16/448,598 (Jun. 21, 2019) ← 15/047,586 (Feb. 18, 2016, now US 10,398,662) ← provisional 62/117,889 (Feb. 18, 2015).
• Anticipated expiration (Google Patents): 2036-02-18.
• Litigation linkage: Delaware D. Ct. cases 1:22-cv-00487 and 1:21-cv-01594; Fed. Cir. 24-2274 and 24-2278. (The operative litigation identified in the record is Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, D. Del. 1:21-cv-00691-GBW / consolidated 1:21-cv-01101, D.I. 77089 & 75471.)

Claims that a §102 analysis must target (independent claims):

• Claim 1 — "A formulation of gamma-hydroxybutyrate comprising: a plurality of immediate release portion particles comprising gamma-hydroxybutyrate; a plurality of modified release portion particles comprising gamma-hydroxybutyrate; a viscosity enhancing agent; and an acid; wherein the viscosity enhancing agent and the acid are separate from the immediate release portion particles and the modified release portion particles."
• Claim 14 — the same combination recited as a unit dose.
• Claims 2–13 (dependents of claim 1) and the remaining dependents of claim 14 add the viscosity-enhancing-agent/acid selections (e.g., xanthan gum, microcrystalline cellulose, HPMC, HPC; malic/citric/phosphoric acid) and dose equivalency (about 4.0–12.0 g sodium oxybate).

(Claim 1 language above is taken from Jazz's Aug. 2, 2021 amendment of the '064 application as reproduced in the D. Del. pleadings; I could not independently load the printed claim set of the granted '782, so treat the exact wording as high-confidence but litigation-sourced.)

2. Legal framework

Because the '782 claims a post‑March 16, 2013 effective filing date, AIA 35 U.S.C. §102(a)–(d) governs. For a single reference to anticipate, it must disclose every element of the claim arranged as claimed. Claim 1 is a multi-component "comprising" formulation with a negative-placement limitation ("viscosity enhancing agent and the acid are separate from the . . . particles"), so true §102 anticipation by any single face-of-patent reference is unlikely; most of the cited art is §103 (obviousness) material. I flag below the small subset that could conceivably reach §102.

3. Face-of-patent "References Cited" (U.S. Patent Documents)

The following are the U.S. references I could positively extract from the '782 front page (partial). Dates are as printed; where the OCR copy conflicted, I use the version derived from the patent's own PDF text.

Flag: Between the truncated US 7,262,2xx entry and US 8,457,988, the middle of the front-page list (which should also contain e.g. US 7,668,730; 7,765,106; 7,765,107; 7,797,171; 7,851,506; 7,895,059; 8,193,211; 8,263,650; 8,324,275; 8,337,890) was not recoverable in my searches. It is present on the printed patent; I simply could not verify it here. Several OCR copies also misprint numbers/dates (e.g., "4,221,177"/"4,359,236"), which I have not auto-corrected.

4. The single most relevant reference actually applied during prosecution

US 2012/0076865 A1 (Allphin et al.), published March 29, 2012 — "Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances."

• Why it matters: The Examiner rejected claims 1–23 of the '064 application under 35 U.S.C. §103 as obvious over Allphin '865, noting it teaches controlled-release dosage forms of GHB and pharmaceutically acceptable salts/complexes, and that a single unit dosage form may incorporate both controlled-release and immediate-release components to provide quick onset plus sustained delivery. Jazz ultimately overcame the rejection by amending claim 1 to require that the viscosity enhancing agent and the acid be separate from the IR and MR particles; the Examiner's Reasons for Allowance (Sept. 9, 2021) state that Allphin does not teach or suggest that separation.
• Claim nexus: Potential §103 art against claims 1 and 14 (and dependents 2–13/15–21) as originally filed. Under §102, Allphin '865 alone does not anticipate, because it lacks the "separate viscosity enhancing agent and acid" placement limitation.

5. Prior art raised by the defendant (outside the face-of-patent citations)

Because the user asked for "the most relevant prior art," these must be flagged even though they are not the printed citations:

• Avadel's US 10,736,866 ('866 patent) — published Jun. 20, 2019; granted Aug. 11, 2020 — modified-release oxybate formulations with a suspending/viscosifying agent and an acidifying agent "separate and distinct from" the oxybate particles. Avadel contended the first four '782 claims were copied from the '866 patent and that '866 is §102(a)(2) art if the '782 is denied its 2015 priority.
• Avadel's US 10,952,986 ('986 patent) — application published Sept. 12, 2019; granted Mar. 23, 2021 — once-nightly modified-release oxybate; alleged §102(a)(2) art.
• Avadel's US 10,272,062 ('062 patent) — published Jan. 25, 2018 — modified-release oxybate formulations.

Avadel's theory: if Jazz cannot establish §112 written-description support for the '782 claims in provisional 62/117,889 / '586 application, then the '782's effective filing date is later (the '598 or '041 application), making the Avadel publications §102(a)(2) prior art ("effectively filed" before the '782's effective filing date). The district court record shows these as the central invalidity/derivation theories.

6. Bottom line on §102

• No single face-of-patent reference appears to §102-anticipate claims 1 or 14. The claims require a specific combination — (i) IR GHB particles, (ii) MR GHB particles, (iii) a viscosity enhancing agent, (iv) an acid, and (v) the agent and acid being separate from the particles — and the cited art generally supplies these elements only piecemeal (resinate/coating art: US 4,221,778, US 6,322,819, US 8,202,537; GHB solution/composition art: US 4,983,632, US 6,472,431, US 5,955,106; multiparticulate art: US 5,594,030, US 6,022,562). Those are §103 combinations, not §102 anticipations.
• The genuine §102 exposure lies in the Avadel '866/'986/'062 publications under AIA §102(a)(2), and it turns on the priority question (whether the '782 can claim the Feb. 18, 2015 provisional date), not on the printed "References Cited."
• The most probative printed citation actually applied is US 2012/0076865 A1 (Allphin), used as §103 art against the '782's parent claims.

Verification status (per operating rules)

• Confirmed from the authorized full text: title, inventors, assignee, application number, filing/grant dates, priority chain, claim-1 subject matter, and the body's incorporation-by-reference list.
• Confirmed from search results (litigation exhibits and Google Patents): the front-page reference list (partial), the Examiner's Allphin '865 rejection, and the Avadel §102 theory.
• Not confirmed / explicitly flagged: the complete unduplicated front-page citation list between US 7,262,2xx and US 8,457,988; exact titles for several older citations; and the printed claim set of the granted '782. I did not fabricate any of these.

Sources: https://patents.google.com/patent/[US11147782B1](/patent/US11147782B1)/en ; https://patentimages.storage.googleapis.com/e4/3a/bd/ef5023f3c9d78b/US11147782.pdf ; https://storage.courtlistener.com/recap/gov.uscourts.cafc.22134/gov.uscourts.cafc.22134.29.0.pdf ; https://storage.courtlistener.com/recap/gov.uscourts.ded.77089/gov.uscourts.ded.77089.238.0.pdf ; https://storage.courtlistener.com/recap/gov.uscourts.ded.75471/gov.uscourts.ded.75471.357.0.pdf ; https://litigationtracker.law.georgetown.edu/wp-content/uploads/2025/01/Jazz-Pharmaceuticals-Inc._2022.02.25_JAZZ-PHARMACEUTICALS-INC.S-FIRST-AMENDED-ANSWER-TO-AVADEL-CNS-PHARMACEU... (Jazz answer to Avadel counterclaims).

I'll start by gathering the actual claim language and the cited prior art for US11147782, since the provided text is truncated before the claims.

I now have the issued claims. Let me pin down the "Prior Art" / references-cited section for this patent and the key related family documents.

Obviousness Analysis — U.S. Patent No. 11,147,782 B1

"GHB formulation and method for its manufacture" (Jazz Pharmaceuticals Ireland Ltd.; inventors Clark Allphin, Scott Bura)
Application 17/210,064, filed 2021‑03‑23; granted 2021‑10‑19; family priority date listed as 2015‑02‑18 (per Google Patents: https://patents.google.com/patent/[US11147782B1](/patent/US11147782B1)/en)

1. Bottom line

Claims 1–22 of US 11,147,782 are, in my analysis, highly vulnerable under § 103, and the vulnerability runs mostly through (a) the breadth of claim 1, (b) the patent's own admissions about the prior art, and (c) the fact that the four claimed elements (IR particles + MR particles + viscosity enhancer + separate acid) were each independently known for oxybate or for analogous high‑dose, water‑soluble drugs, with well‑articulated reasons to combine.

Two threshold points drive everything:

1. The issued claims are not the claims of the 2016 application. Claim 1 as issued ("plurality of immediate release particles … plurality of modified release particles … a viscosity enhancing agent … and an acid …") was added in the 2020–2021 continuation chain. In the co‑pending Delaware litigation (C.A. 21‑cv‑00691; consolidated with 1:21‑cv‑01594), the court held that Jazz was not entitled to the 2015/2016 priority date for at least certain limitations (the blood‑concentration range), so the operative effective filing date for those claims is, at the earliest, 2020‑12‑10 (the 17/118,041 filing) or 2021‑03‑23 (see the Feb. 14, 2024 opinion and D.I. 357 in Jazz Pharms. v. Avadel, e.g. https://storage.courtlistener.com/recap/gov.uscourts.ded.75471/gov.uscourts.ded.75471.357.0.pdf).
2. The specification itself concedes the state of the art. It states that "extended release oxybate dosage forms are known," and that "[d]rug‑resin complexes including modified release drug‑resin complexes are known." Those are classic applicant admissions usable as prior art (MPEP § 2129).

I have to flag one methodological caveat up front: the fetched copy of the Google Patents page was truncated before the machine‑generated citation list, so I could not read that table row‑by‑row. The "Prior Art" material I used below is therefore (i) the references the patent's own specification identifies and incorporates (the "Prior Art" narrative on the page), and (ii) the prior‑art document list Google/Unified Patents surfaces for this family ("Patent Art (164)," e.g. https://portal.unifiedpatents.com/patents/patent/US-[10398662](/patent/10398662)-B1). I mark uncertainty where it exists.

2. The claims

Claim 1 (independent):

A formulation of gamma‑hydroxybutyrate comprising:
• a plurality of immediate release particles comprising gamma‑hydroxybutyrate;
• a plurality of modified release particles comprising gamma‑hydroxybutyrate;
• a viscosity enhancing agent; and
• an acid;
wherein the viscosity enhancing agent and the acid are separate from the immediate release particles and the modified release particles.

Structural logic: no limitation to a resinate; no limitation on the mechanism of modified release; no limitation on the identity of the acid; no limitation on dosing (beyond the dependent grams claims) and no limitation that the formulation be liquid — although the viscosity enhancer strongly implies an aqueous suspension dosage form.

Dependent claims relevant to § 103:

• 2 — viscosity enhancer selected from xanthan gum, microcrystalline cellulose, HEC, HPMC, CMC‑Na, HPC (a closed list of conventional suspending agents).
• 3 — acid selected from malic, citric, tartaric, boric, maleic, phosphoric, benzoic.
• 4–5 — lubricant; magnesium stearate.
• 6–10 — 4.0–12.0 g; about 6 g; about 7.5 g; about 9 g (GHB equivalents of sodium oxybate).
• 11–12 — 8 h post‑administration blood concentration 10 mg/L–about 40 (printed "mg/mL"); 15–30.
• 13 — multiparticulate composition.
• 14–22 — unit dose counterparts.

Claim 11's "mg/mL" is written literally in the printed claim (see the patent PDF at https://patentimages.storage.googleapis.com/e4/3a/bd/ef5023f3c9d78b/US11147782.pdf); I am not auto‑correcting it, but note the unit inconsistency with the "mg/L" elsewhere in the same claim set and the specification.

3. The prior art available

Finally, note the "Prior art keywords" the page itself surfaces — formulation, gamma, hydroxybutyrate, acid, sodium — which is Google's machine classification, not legal prior art; I mention it only because the "acid" keyword tracks the claim element that is hardest to find in pre‑2015 GHB art.

4. Element‑by‑element mapping of claim 1

(a) "plurality of immediate release particles comprising gamma‑hydroxybutyrate"
Fully met by Allphin 2012 (IR component of an oral oxybate formulation), and by the Xyrem® immediate‑release prior art (US 6,472,431; 8,591,922; etc.). Nothing more than "oxybate that dissolves."

(b) "plurality of modified release particles comprising gamma‑hydroxybutyrate"
Met by Allphin 2012's controlled‑release component, by US 2006/0210630 (Supernus), by WO 2007/103200 (Watson), and — on the resinate reading — by Fisons 4,221,778, Supernus 8,202,537 and Tris 2012/0148672. Critically, the '782 specification admits that "extended release oxybate dosage forms are known" and that modified‑release drug‑resin complexes are known, so this element is admitted art.

(c) "a viscosity enhancing agent … separate from" the particles
The specification's own excipient list (xanthan gum, microcrystalline cellulose, hydroxyethyl cellulose, HPMC, CMC‑Na, HPC) is the conventional suspending‑agent set; the same agents are taught for ER suspensions by Sun (2016/0228379; 2017/0340519). Executing the "liquid dosage form" already contemplated by the specification requires a suspending agent; selection is routine (MPEP 2144.04 — obvious choice among a finite list of known equivalents).

(d) "an acid … separate from" the particles
This is the only element with genuine question marks in the pre‑2015 art. Three § 103 paths:

• Avadel/Flamel‑family publications describing a once‑nightly oxybate formulation with IR and modified‑release particles and a separate acid component (in the litigation, Avadel's counsel described the "separate acid" to hold gastric pH low as central to its formulation; Flamel's published applications recite IR/MR particle combinations, e.g. US 2024/0173286 A1 ¶¶ 0753–0754 — https://patentimages.storage.googleapis.com/ac/2a/aa/30427183fa00da/US20240173286A1.pdf). I could not verify from the materials provided the exact priority dates/numbers of the Avadel‑originated publications, so treat that as a lead to confirm, not a settled citation.
• The patent's own problem statement (usable as an admission of the problem, though not itself prior art): "The buffering capacity of GHB may affect gastric pH and compromise performance of enteric‑coated dosage forms." Once a POSA appreciates that a 6–9 g oxybate dose neutralizes gastric acid (the spec says the IR portion drives gastric pH "to about 6"), adding a pharmaceutically acceptable acid to maintain an acidic gastric environment is the obvious, conventional fix — and the patent lists exactly such acids (malic, citric, hydrochloric, etc.).
• General pharmaceutical acidulant art — organic acids (citric, tartaric, malic) are standard acidulants/pH adjusters in oral solid and liquid dosage forms (Remington, incorporated by reference in the spec).

5. The § 103 combinations

Combination A (primary): Allphin 2012 + Sun ER‑suspension art + acidulant/enteric‑pH art

Allphin 2012 (US 2012/0076865 A1) discloses an oral oxybate formulation with an IR component and a CR component and single‑daily dosing. Sun (US 2016/0228379 A1; US 2017/0340519 A9) teaches converting multi‑particulate ER products into pourable aqueous suspensions using viscosity‑enhancing/suspending agents. The acidulant art teaches maintaining gastric pH with a separate acid.

Motivation to combine: (i) the known short half‑life of GHB, which is why the prior art teaches twice‑nightly dosing — a once‑nightly product is a recognized "long‑felt need" and a "design need" (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)); (ii) the required dose is very high (6–9 g), producing large tablets or multiple tablets, with known dysphagia/compliance problems — a recognized reason to move to a liquid/suspension (the '782 spec admits exactly this); (iii) a suspension of a high‑density particulate needs a suspending agent to be dose‑uniform — routine; (iv) the oxybate dose itself raises gastric pH and would dissolve enteric coatings on the MR particles, giving a specific, articulated reason to include a separate acid. Each element performs its own known function → predictable result.

Combination B (resinate flavor): Fisons 4,221,778 + Supernus 8,202,537 + Tris 2012/0148672 + Allphin 2012 + suspending agent + acid

Fisons and Supernus 8,202,537 teach drug‑loaded ion‑exchange resin beads (the MR particles); Tris 2012/0148672 teaches that a single drug‑resin product can be engineered to give both immediate and extended release phases; Allphin 2012 teaches IR + CR oxybate dosing; Sun teaches the suspension vehicle. Motivation: high loading/less resin, taste masking, and controlled release of a very high‑molar‑dose drug — all expressly recited as the goals in the '782 specification.

Combination C (the patent's own admissions as the primary reference)

The '782 specification admits: (1) extended‑release oxybate dosage forms are known; (2) drug‑resin complexes, including modified‑release ones, are known (citing US 8,202,537); (3) GHB's buffering capacity compromises enteric dosage forms; (4) a liquid dosage form is desired because tablets are too large; and (5) the excipient inventory (viscosity enhancers; acids/pH adjusters). Those admissions, taken with Allphin 2012's IR+CR oxybate disclosure, supply a prima facie case in which the only remaining "invention" is the co‑location of four known excipient/particle classes in one dosage form — classic obviousness (MPEP 2143(A); In re Kollman, 595 F.2d 48 (CCPA 1979)).

Combination D (if the 2019/2021 filing date governs)

If claim 1 is not entitled to the 2015/2016 priority date (as the district court held for at least the concentration limitation), then Jazz's own intervening "Sustained Release Patents" family — US 10,758,488; 10,813,885; 10,959,956; 10,966,931 (Allphin et al., "Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances," priority traced in the litigation to an application filed March 24, 2011) — plus the published Flamel/Avadel applications, become § 102(a)(2)/§ 103 art. I flag that § 102(b)(2)(C) common‑ownership disqualification would need to be worked through for the Jazz‑owned documents, and that this combination depends entirely on the priority ruling.

6. On the dependent claims

• Claims 2–5 (excipient species): routine selection from a finite, enumerated list of known agents — obvious per MPEP 2144.04.
• Claims 6–10 (dose amounts): 6 g, 7.5 g and 9 g are the marketed Xyrem® strengths (the '782 spec says Xyrem is "6 g to 9 g"); dosing a formulation to a known effective amount is not inventive (In re Boesch, 617 F.2d 272 (CCPA 1980)) and result‑effective-amount claims are obvious when the result was known to be desirable.
• Claims 11–12 (8‑h blood levels): these are the limitations the district court found unsupported by the 2015/2016 priority documents, which both weakens the priority claim and strengthens the "obvious to try" analysis; the specification's own target ("about 10 mg/L to about 20 mg/L … for up to 8 … hours") frames the objective, and the prior art (Allphin 2012; the 8,778,398/8,859,619 dosing patents) gives the direction.
• Claim 13 / 14–22 (multiparticulate; unit dose): the specification itself is a multi‑particulate/unit‑dose disclosure; Allphin 2012 discloses sachets and unit dose formats.

7. Counterarguments the patentee will raise (and how they fare)

1. Teaching away / "unsuitable for very high doses." The '782 spec argu[es] that resinates "would typically be considered unsuitable for very high dose … drugs such as oxybate." This is a teaching‑away argument, but it cuts the wrong way for claim 1, which is not limited to resinates and therefore reads on the very non‑resinate, coated/matrix MR oxybate particles the specification says are already known.
2. Unexpected results / long‑felt need. Jazz will point to the once‑nightly LUMRYZ® product, the ~40‑year dominance of twice‑nightly Xyrem®, and evidence (including, per the trial transcript, that outside consultants rated the pellets approach as <1% likely to succeed) to argue non‑obviousness. A nexus between the claimed elements (viscosity enhancer + separate acid) and the unexpected result would be required; given the broad genus, nexus will be contested.
3. Criticality of the separate acid. If the record shows the acid must be external to the particles to preserve an enteric coating, Jazz will argue criticality. But adding a known acidulant to a known enteric‑coated multi‑particulate to protect the coating is a predictable, purposive step (KSR, "design incentives and other market forces").
4. Breadth/enablement overlap. The same claim breadth that makes the claims easy to invalidate under § 103 is the basis of Avadel's § 112(a) enablement attack (the '782 patent "enables" resinate particles at most; the claims purport to cover "infinity" of formulations). Though § 112 is not § 103, the breadth simultaneously maximizes the prior‑art surface for the obviousness case.

8. Confidence and gaps

• High confidence: the claim text; the family lineage (17/210,064 ← 17/118,041 ← 16/448,598 ← 15/047,586/U.S. 10,398,662 ← provisional 62/117,889); the identity of the incorporated‑by‑reference prior art listed in the specification; the existence and general holdings of the Delaware opinions on priority and enablement.
• Moderate confidence: the specific disclosures of Allphin 2012 (US 2012/0076865 A1) at ¶ 0042 — I am relying on the litigation record's characterization of that paragraph, not a re‑read of the reference itself.
• Low / unverified: the exact patent numbers, publication dates and priority dates of the Avadel/Flamel "once‑nightly" publications that teach the separate acid. The materials I retrieved show Avadel's specification language (IR/MR particle combinations in US 2024/0173286 A1) and the litigation narrative attributing the separate‑acid concept to Avadel, but I could not confirm bibliographic dates. Anyone relying on this combination should pull the file wrappers and confirm the 102(a)(2)/102(a)(1) status of each Avadel/Flamel document.
• Not reviewed: the full machine‑generated "Patent Citations" table on the Google Patents page for US 11,147,782 (the fetched copy truncated before it). A complete § 103 opinion should be rebuilt off that table plus a full search of the 2014–2020 oxybate CR/suspension art.

Nothing above is a legal opinion or a freedom‑to‑operate/validity conclusion; it is a technical obviousness analysis intended to identify the combinations and motivations a challenger (or examiner) would most plausibly assert.