US 10966931

I'll search for authoritative information on this patent and any related litigation.

Let me search for the specific claims and litigation status of this patent.

Let me get the actual independent claim language and confirm the litigation outcomes.

I've gathered authoritative and secondary-source information. Note: I hit my tool-call limit before I could pull the full verbatim claim text from the USPTO, so I flag below exactly where I am inferring rather than quoting.

US Patent 10,966,931 (US10966931B2)

Bibliographic data (verified)

Continuity chain (from the patent's own "Related Applications"): 17/012,831 is a continuation of 16/916,677 (Jun 30, 2020 → issued as US 10,813,885) → continuation of 16/712,260 (Dec 12, 2019) → continuation of 16/025,487 (Jul 2, 2018 → issued as US 10,758,488) → continuation of 13/071,369 (Mar 24, 2011, abandoned) → benefit of provisional 61/317,212 (Mar 24, 2010). It is one of the four so-called "Sustained Release Patents" ('488, '885, '956, '931), which share a common specification.

Abstract (verbatim)

"Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form."

Plain-language overview

The patent addresses a formulation problem: gamma-hydroxybutyrate (GHB, e.g., sodium oxybate) must be dosed in large amounts, is extremely water-soluble, low-molecular-weight, and highly hygroscopic, so it is hard to make into a controlled-release oral pill that is small enough to swallow and does not "dose dump." The disclosed solution is a coated tablet: a high-drug-load core (GHB/oxybate, 90–98% w/w) covered by a functional rate-limiting coating (e.g., ethylcellulose or methacrylic acid–methyl methacrylate co-polymers, plus a pore former such as HPC), optionally topped with an immediate-release (IR) overcoat and a moisture barrier. Release is engineered to be time-dependent rather than pH-dependent, which the patent argues reduces inter-patient variability versus the prior art (Liang et al., US 2006/0210630).

Independent claims — overview

⚠️ Confidence note: The Google Patents text I retrieved did not include the full claim set. The description below is reconstructed from the patent's common specification and from court filings (Avadel's invalidity contentions and the Jazz v. Avadel claim-construction record), which quote the '931 claim language. Treat the exact wording as paraphrase, not verbatim.

The '931 patent is a method-of-use patent in the same family as the formulation patents '488/'885 and the method patent '956. It has roughly 15 claims (Jazz asserted claims 1–6 and 8–15; claim 7 was not asserted).

Independent claim 1 — a method of treating/administering (per Jazz's own characterization, "a method of administering a GHB formulation... to provide rapid and extended therapeutic benefit"), comprising administering a formulation having immediate-release and sustained-release portions, each containing GHB or a pharmaceutically acceptable GHB salt, wherein:

• the sustained-release portion comprises a core with a functional coating deposited over it;
• the functional coating comprises one or more methacrylic acid–methyl methacrylate co-polymers at about 20%–50% by weight of the coating (confirmed as present in '931 at col. 28:1–4 by Avadel's contentions);
• the sustained-release portion contains about 500 mg to 12 g of GHB/salt; and
• the sustained-release portion releases greater than about 40% of its GHB by about 4 to about 6 hours, when tested in USP Dissolution Apparatus 2, deionized water, 37 °C, 50 rpm paddles (confirmed at '931 col. 28:5–9).

Independent claim 8 (likely) — appears to be a further independent method claim; claims 8–15 were asserted, and the '931 pattern in this family generally pairs an initial independent claim set (1–6) with a second independent claim (8) plus dependents.

Representative dependent limitations (from the shared family record):

• IR portion contains about 10%–50% by weight of the total drug;
• overall formulation releases at least about 30% by 1 hour and greater than about 90% by 8 hours (Apparatus 2, deionized water, 37 °C, 50 rpm);
• GHB salt selected from calcium, lithium, potassium, sodium, and magnesium salts;
• timing/route limitations (e.g., dosing at night) and Cmax/Cmin and plasma-concentration (≥10 µg/mL) profiles in some claims.

Litigation / docket status

District Court (D. Del.):

• Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 1:21-cv-00691 (filed May 12, 2021) — the '931 patent was asserted against Avadel's once-nightly sodium oxybate product (FT218 / LUMRYZ™), together with the '488, '885, '956, '963, '079, and '782 patents. Consolidated with 21-1138 and 21-1594 (and 22-487 on the same schedule).
• Claim construction (Judge Gregory B. Williams, opinion, 21-691): "sustained release portion" given its plain and ordinary meaning ("the portion of the formulation that is not immediate release and that releases over a period of time"); the parties agreed that "by about 4 to about 6 hours" means "at any point prior to approximately 4 hours or at any point prior to approximately 6 hours."
• Feb 29, 2024 summary-judgment opinion: the court noted Jazz had narrowed its trial case to the '488 and '782 patents; the '931 patent was therefore not tried.
• Avadel CNS Pharmaceuticals v. Jazz Pharmaceuticals, No. 1:22-cv-00487 (filed April 14, 2022) — Avadel sought correction of inventorship, alleging Jazz derived/copied the '931 and sibling claims from Avadel's confidential disclosures and '062/'866/'986 publications.

Federal Circuit:

• No. 23-1186 — a secondary source (PatSnap litigation blog) reports the Federal Circuit affirmed unpatentability of five patents, expressly listing US10966931B2, US8731963B1, US10758488B2, US10959956B2, and US10813885B1. ⚠️ This is a secondary, AI-generated-looking summary — I could not independently verify it against the opinion itself, and I have not confirmed which claims or which tribunal (IPR/PTAB) produced the unpatentability holding.
• No. 24-2274 (Avadel CNS v. Jazz Pharmaceuticals) — PACER reportedly records a judgment of "REVERSED-IN-PART, VACATED-IN-PART, AND REMANDED." Again, secondary source; treat as unverified.

Re: your specific request for "CAFC 2026 dockets." I did not find any Federal Circuit appeal docketed in calendar year 2026 that specifically names US 10,966,931. The Federal Circuit matters I identified for this patent family (23-1186 and 24-2274) were docketed in 2023 and 2024, though 24-2274 may have had appellate activity carrying into 2026. I flag this as an open item rather than assert a 2026 filing.

Explicit uncertainties

1. Verbatim claim text — not retrieved; the independent-claim overview above is reconstructed and paraphrased.
2. Number/identity of independent claims — I infer claim 1 (method) and a second independent claim (likely claim 8); this is not confirmed.
3. Federal Circuit outcomes — based on secondary litigation summaries, not the primary opinions; confirm via PACER/CAFC opinions before relying on them.
4. The '931 patent must not be conflated with its sibling US 10,959,956 ("956 patent") or the reissue-listed US 10,996,931 appearance in one court filing — these are distinct documents.

I'll research litigation involving US patent 10966931 using the sources you specified.

Let me get more detail on the specific case numbers and CAFC appeals.

Let me verify the specific cases asserting the '931 patent and their outcomes, including any ANDA litigation.

Based on my searches of Unified Patents, CourtListener/PACER records, drugpatentwatch, Federal Circuit opinions, and court filings, here is what I found regarding litigation involving US Patent 10,966,931.

A threshold note: the '931 patent is part of Jazz Pharmaceuticals' "sodium oxybate sustained-release" patent family (priority date March 24, 2010), and it has been litigated primarily alongside sibling patents (e.g., US 10,758,488; 10,813,885; 10,959,956; US 8,731,963; US 11,147,782). The litigation reports below distinguish cases where the '931 patent was directly asserted from appeals concerning sibling patents in the same consolidated litigation.

1. Jazz Pharmaceuticals, Inc. (and Jazz Pharmaceuticals Ireland Ltd.) v. Avadel CNS Pharmaceuticals LLC (and affiliated Avadel entities)

This is the case in which US 10,966,931 was directly asserted.

• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited
• Defendants: Avadel CNS Pharmaceuticals, LLC (originally along with Avadel Pharmaceuticals plc, Avadel US Holdings, Avadel Management Corp., Avadel Legacy Pharmaceuticals, LLC, and Avadel Specialty Pharmaceuticals, LLC; the non-CNS entities were dismissed Jan. 4, 2022)
• Jurisdiction: U.S. District Court for the District of Delaware
• Case numbers: C.A. No. 1:21-cv-00691 (GBW) — "First Complaint" — consolidated/related with 1:21-cv-01138 (GBW) and 1:21-cv-01594 (GBW)
• Filing date: May 12, 2021 (First Complaint)
• Patents asserted: U.S. Patent Nos. 8,731,963; 10,758,488; 10,813,885; 10,959,956; and/or 10,966,931. The four later patents ('488, '885, '956, '931) were collectively referred to as "the Sustained Release Patents" and were the subject of Jazz's Motion for Partial Summary Judgment No. 3 of Nonobviousness (filed Nov. 30, 2023).
• Status/outcome: The case proceeded through extensive claim construction, summary judgment, and trials (a February 2024 jury trial, among other proceedings). All claims and counterclaims between Jazz and Avadel were ultimately dismissed WITH PREJUDICE by stipulation dated Oct. 24, 2025, entered by Judge Gregory B. Williams on Oct. 27, 2025, pursuant to a settlement agreement.

Related Federal Circuit appeals arising from this consolidated litigation:

• Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 23-1186 (Fed. Cir.) — appeal from D. Del. 1:21-cv-00691. Decided Feb. 24, 2023: affirmed the district court's order requiring Jazz to delist the "REMS Patent" (US 8,731,963 — a sibling, not the '931) from the Orange Book. (Google Patents links this appeal to the '931 family.)
• Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 24-2274 (Fed. Cir.) — appeal from D. Del. Nos. 21-0691, 21-1138, 21-1594. Decided May 6, 2025: reversed-in-part, vacated-in-part, and remanded the district court's permanent injunction. The court held the injunction improperly barred Avadel from initiating new clinical trials (safe harbor under 35 U.S.C. § 271(e)(1)) and vacated the portion barring Avadel from seeking FDA approval for new indications (remanding on the § 271(e)(2) question). Note: the merits patent underlying this injunction was the '782 patent (sodium oxybate formulation), a sibling, not the '931.

2. Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.

This is the case Google Patents flags as "Family has litigation" for the '931 patent.

• Plaintiff: Avadel CNS Pharmaceuticals, LLC (and Avadel Pharmaceuticals PLC, Flamel Ireland Limited)
• Defendant: Jazz Pharmaceuticals, Inc. (and Jazz Pharmaceuticals Ireland Limited)
• Jurisdiction: U.S. District Court for the District of Delaware
• Case number: 1:22-cv-00487 (GBW)
• Filing date: April 14, 2022
• Patent identifiers appearing in the docket: The complaint/docket references include U.S. Patent Nos. 10,758,488; 10,813,885; 10,959,956; 10,966,931; 8,731,963; 11,077,079 (as well as Avadel's own patents 10,272,062; 10,736,866; 10,952,986; and others). This is a related action (mirror-image/declaratory-judgment and follow-on litigation) in the same Jazz–Avadel sodium oxybate dispute.
• Status/outcome: Terminated — dismissed by stipulation/order on Oct. 27, 2025 (Judge Gregory B. Williams), consistent with the global settlement dismissing the related consolidated cases (21-691, 21-1138, 21-1594, 22-941, etc.).

Important caveats

• Direct vs. familial assertion: The clearest direct assertion of US 10,966,931 is in Jazz's First Complaint (D. Del. 1:21-cv-00691, filed May 12, 2021), where it was one of the five patents-in-suit and one of the four "Sustained Release Patents." The two Federal Circuit appeals (23-1186 and 24-2274) that Google Patents lists for this family were decided on sibling patents ('963 and '782 respectively), so they should not be described as '931 merits appeals — they are associated with this patent via the consolidated litigation/family.
• ANDA litigation: I did not find any Abbreviated New Drug Application (ANDA) litigation — e.g., against generic filers such as Amneal, Par, Roxane, Wockhardt, or Lupin — specifically asserting 10,966,931. The older Jazz ANDA suits (Roxane, Amneal, etc.) involved the earlier distribution-system and solution patents ('431, '889, '219, '506, '059, '650, '275, '730, '106, '107, '963), not the '931. I cannot rule out an ANDA case I did not surface, but I found no evidence of one.
• I was unable to complete additional verification searches (I reached the tool-use limit), so the above reflects the records retrieved at this time; you should confirm current status via PACER/CourtListener dockets (D. Del. 1:21-cv-00691, 1:22-cv-00487) and the Federal Circuit dockets for 23-1186 and 24-2274 before relying on it.

Bottom line: The known litigation involving US 10,966,931 consists of the Jazz v. Avadel sodium-oxybate litigation in the District of Delaware (directly asserted in C.A. No. 1:21-cv-00691, and referenced in the related action 1:22-cv-00487), with associated Federal Circuit appeals (Nos. 23-1186 and 24-2274) arising out of the same litigation family. All of these matters were resolved and dismissed with prejudice on Oct. 27, 2025 following a settlement between Jazz and Avadel.

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

Let me search specifically for IPR petitions involving Avadel and the sustained-release patents.

Let me do two final targeted checks for any PTAB filing on the '931 patent specifically.

PTAB Proceedings — U.S. Patent No. 10,966,931

Verification note: Per the structured "PTAB proceedings on file" block (USPTO ODP), there are zero AIA trial proceedings against this patent. I ran independent web searches against PTAB dockets, litigation trackers, and press/financial filings to look for petitions the ODP may not have ingested. Nothing surfaced. I could not locate any IPR, PGR, or CBM petition, institution decision, FWD, or appeal involving US 10,966,931. I am flagging this as "no PTAB activity on file," verified as far as public search permits — not as a positive finding that a filing is impossible.

Proceedings overview

Total AIA trial proceedings on US 10,966,931: 0 (0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution-denied). The bottom line for a defendant: there is no PTAB record to exploit. No claim of the '931 patent has been canceled, and no claim has been confirmed in a Board FWD. All 15 claims remain statutorily intact and untested at the PTAB. The patent's validity fight has been waged entirely in district court and the Federal Circuit — not at the Board — which means the "IPR-based defense" playbook that usually anchors a paragraph-IV or 505(b)(2) clearance strategy is unavailable as precedent, though also unencumbered by prior-petitioner estoppel. The '931 patent is best characterized as untested, not hardened and not weakened.

Per-proceeding detail

None. There are no {PROCEEDING_NUMBER} entries to report for this patent. I will not invent docket numbers or FWDs.

Adjacent-but-distinguishable: the 2015 Xyrem distribution-patent IPRs (NOT this patent)

Because Jazz's sodium oxybate portfolio has a PTAB history, a defendant may hear "Jazz patents got IPR'd before." That history is irrelevant to the '931 patent and should not be conflated:

• Filed: January 2015, by [Amneal Pharmaceuticals LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%20LLC) and Par Pharmaceutical, Inc.
• Subject patents: the distribution-system patents (the '730 patent family), not the sustained-release formulation family that produced the '931 patent.
• Institution: 2015-07-28, the PTAB instituted IPR on five patents, instituting on some grounds and rejecting others. Source: Jazz Pharmaceuticals plc Form 8-K, 2015-07-28 — http://www.getfilings.com/sec-filings/[150729](/patent/150729)/Jazz-Pharmaceuticals-plc_8-K/
• Defensive value for the '931 patent: None. Different patents, different claims, different petitioners. No § 315(e) estoppel from the 2015 IPRs reaches the '931 claims.

Strategic summary

Claim status. The '931 patent issued with claims 1–15 (Jazz asserted "claims 1-6 and 8-15" in one Delaware filing and "claims 1-15" in another — see the Charman Second Supplemented Opening Expert Report, D. Del. 1:21-cv-00691, D.I. 581: https://storage.courtlistener.com/recap/gov.uscourts.ded.75471/gov.uscourts.ded.75471.581.0.pdf). All 15 claims are UNTESTED at the PTAB. None are canceled; none are Board-confirmed. District-court validity contentions (Avadel's theory was § 112 written description/enablement plus § 102 anticipation, per that report) do not carry Board preclusive effect for anyone.

Estoppel landscape. Because no IPR was ever instituted on this patent, § 315(e)(2) estoppel does not attach to the '931 patent. That cuts both ways for a defendant: (a) there is no petitioner estoppel that would preclude you from raising art the 2015 Amneal/Par petitioners or any other party raised against other Jazz patents; but (b) there is also no FWD available to borrow as "the Board already found this art invalidating." Note the § 315(b) one-year clock is the real constraint: it runs from service of a complaint alleging infringement of this patent. Avadel was served in 2021, so any IPR window for it closed long ago — but a newly served defendant has a fresh one-year window. Note also that PGR is very likely unavailable here: the '931 claims descend from a 2010-03-24 priority date (the patent's own stated priority), predating the March 16, 2013 AIA effective-filing-date threshold for PGR eligibility under § 321(c) — assuming, as the record indicates, the claims are entitled to that 2010 priority. CBM is definitionally inapplicable (drug formulation patent) and the CBM program sunset on 2020-09-16.

Pattern signals.

• No repeat-petitioner pattern on this patent — because there is no petitioner at all.
• The patent owner did not need to defend at the PTAB. Jazz's enforcement of the sustained-release family ran through D. Del. 1:21-cv-00691-GBW (consolidated with 1:21-cv-01138 and 1:21-cv-01594), filed 2021-05-12 naming the '963, '488, '885, '956, and '931 patents. Validity was litigated to a jury trial held 2024-02-26 to 2024-03-01.
• Federal Circuit activity is real but is not PTAB-appeal activity — it is district-court appeal activity. The '931 patent appears in the caption/dispute background of the Fed. Cir. appeal decided 2025-05-06 (Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, 2024-2277, 2024-2278, 136 F.4th 1075, REVERSED-IN-PART, VACATED-IN-PART, AND REMANDED — https://cases.justia.com/federal/appellate-courts/cafc/24-2274/24-2274-2025-05-06.pdf). That appeal concerned the permanent injunction (Safe Harbor under § 271(e)(1) for clinical trials), not an FWD. Separately, docket 23-1186 was Jazz's appeal of the REMS-patent delisting order, affirmed 2023-02-24.
• No defensive aggregator (e.g., Unified Patents, RPX) appears in the chain as a petitioner. The Unified Patents link in the structured data is a litigation data source citation, not evidence of a Unified-filed IPR.
• The patent has been litigated in Delaware, before Judge Gregory B. Williams, and the entire matter was resolved by a Settlement and License Agreement dated 2025-10-21 between Jazz and Avadel CNS, with dismissals with prejudice entered 2025-10-27 (per Avadel's Form 10-Q disclosure). That settlement is a district-court settlement and does not create a PTAB termination to cite.

Recommended next steps

1. State the negative plainly in any opinion or diligence memo: "A comprehensive search of USPTO PTAB records and public litigation trackers identified no AIA trial proceeding — IPR, PGR, or CBM — involving U.S. Patent No. 10,966,931." Do not let a reviewer assume an IPR exists because Jazz's other patents (the '730 distribution family) were IPR'd in 2015.

2. If you are a defendant facing assertion of the '931 patent: your § 315(b) one-year clock starts at service of the complaint. Because no prior IPR exists on this patent, you face no § 315(e)(2) estoppel, and the pre-AIA priority date likely blocks a PGR — so IPR is the only AIA vehicle available, and it must be built from scratch on §§ 102/103 art. You cannot cite a prior FWD; you would be the first petitioner.

3. Mine the Delaware record rather than the PTAB record. The operative validity theories on the sustained-release family were: (i) § 112 enablement/written description, and (ii) § 102 anticipation (Liang 2006, Lebon 2013, and Avadel's own publications), plus an inventorship/derivation theory (Drs. Guillard and Mégret). See the Charman report and the trial transcript excerpts (D.I. 581; D.I. 598) at the Georgetown Litigation Tracker: https://litigationtracker.law.georgetown.edu/. The Fed. Cir. 24-2274 opinion (2025-05-06) is the most current appellate statement on the portfolio's posture.

4. Confirm the '931's trial disposition before relying on the 2024-03-04 verdict. The jury verdict as reported returned no infringement of the '488 patent and infringement of the '782 patent; public summaries I located do not confirm that the '931 claims reached the jury. I could not verify whether the '931 was dismissed, dropped, or tried. Do not represent that a jury upheld or rejected the '931 claims without pulling the D. Del. docket in 1:21-cv-00691-GBW directly.

5. Verify on PTAB E2E yourself before finalizing. My conclusion rests on the ODP structured block plus web search. For a filing decision, directly query PTAB E2E (https://ptacts.uspto.gov/ptacts/) and the PTAB Decision pages for "10,966,931," and re-check after any new complaint is served — new petitions against a patent this central to the Lumryz/Xyrem dispute are plausible, and the ODP ingest lag you flagged is a real risk.

Confidence statement: I am highly confident there is no PTAB proceeding on US 10,966,931 in public records as of 2026-10-01. I am not confident about the claim-level trial disposition of the '931 patent, and I have said so rather than guess. No proceeding numbers, judge panels, FWD holdings, or appeal dispositions are fabricated above, because none exist for this patent.

I'll research this patent's assignment record and litigation history before reconstructing the ownership chain.

Let me dig into the specific assignment records and reel/frame numbers.

Let me try to pin down the specific reel/frame records and check the USPTO assignment database directly.

I've gathered the authoritative patent record, the Google Patents legal-events data, and the litigation context. Two caveats up front: (a) I was unable to pull the raw Assignment Center reel/frame and correspondent fields for this specific patent within my tool budget, and I will not fabricate them; and (b) I am reporting only what the fetched sources support.

Inventors

Notes on pattern: the family runs from the 2010 provisional (61/317,212) through the 2020 continuation, and consistently names only this small group. There is no evidence in the record of inventors departing Jazz within 12 months of filing, and no fire-sale precursor signal. Allphin's continuing role as Jazz's testifying expert (2024 trial) is inconsistent with abandonment.

Original assignee

Jazz Pharmaceuticals, Inc. (a Delaware corporation; principal place of business historically 3180/3170 Porter Drive, Palo Alto, CA; parent Jazz Pharmaceuticals plc, NASDAQ: JAZZ, now Dublin‑domiciled).

• Line of business: commercial specialty pharmaceutical company.
• Product embodying oxybate franchise: Jazz markets Xyrem® (sodium oxybate oral solution) and Xywav® (calcium/magnesium/potassium/sodium oxybate oral solution). Jazz is a multi‑billion‑dollar revenue operating company, not a licensing vehicle.
• Current status: operating and public. It is a serial patent plaintiff against ANDA filers and against Avadel, and it is the named defendant in Avadel's parallel antitrust/trade‑secret suit.
• Family ownership nuance: the issued US 10,966,931 B2 is recorded to Jazz Pharmaceuticals, Inc. (Google Patents lists it as both original and current assignee), whereas several sibling oxybate patents (e.g., US 11,147,782; US 11,426,373) name Jazz Pharmaceuticals Ireland Limited. That is an intra‑group allocation decision, not evidence of a third‑party transfer.

Assignment timeline

Note: the authoritative Google Patents legal-events feed for US 10,966,931 B2 shows two assignment/security events post‑filing (in addition to the ordinary inventor vesting). Raw reel/frame and correspondent fields were not retrievable from the sources I could reach; I flag these as "not captured" rather than guess. Verify at the Assignment Center (https://assignmentcenter.uspto.gov/ or https://assignment.uspto.gov/patent/index.html) by patent number.

• 2020‑12‑11 (recorded; execution date not shown) — Reel NNNNNN/NNNN — not captured

  • Conveyance: Assignment (inventor → assignee; shown as "reassignment")
  • Assignor: Allphin, Clark Patrick; Pfeiffer, James Frederick
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not captured in available feed (no recurrence can be asserted)
  • Context: Routine perfection of title — the two named inventors assigned their rights in application 17/012,831 to the original assignee. Not a transfer to a third‑party asserter.

• 2021‑05‑05 (recorded) — Reel NNNNNN/NNNN — not captured

  • Conveyance: Security Agreement (grant of a security interest / lien, not an ownership transfer)
  • Assignor (grantors): Cavion, Inc.; Celator Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee (secured party): U.S. Bank National Association
  • Correspondent: not captured in available feed
  • Context: Securitization / collateral grant — the U.S. Bank and Bank of America credit facility dated May 5, 2021 (the financing associated with the GW Pharmaceuticals acquisition). It encumbers the patent portfolio across multiple Jazz entities; ownership stays with Jazz.

• No other recorded assignments appear in the legal‑events feed. There is no chain of IP‑holding LLCs, no transfer to any named NPE, and no assignment to a defensive aggregator.

Timeline diagram

timeline
    title Ownership of US 10966931
    2010 : Earliest priority filing
    2011 : Parent application filed
    2020 : Continuation filed by Jazz
         : Inventors assign rights to Jazz
    2021 : Patent issued as US10966931B2
         : Security agreement to US Bank
         : Jazz sues Avadel for infringement
    2022 : Avadel files Delaware counter-suit
    2024 : Jury verdict partial

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The chain terminates at Jazz Pharmaceuticals, Inc.; no "IP / Holdings / Ventures / Licensing" LLC appears in any recorded conveyance (2020‑12‑11 and 2021‑05‑05 records). There is no single‑purpose Delaware/Texas assignee and no registered‑agent address.

2. Known asserter in the chain — not present. Neither Jazz Pharmaceuticals, Inc. nor Jazz Pharmaceuticals Ireland Limited appears on the Acacia / Marathon / IV / Wi‑LAN / Conversant / Vringo / Pendrell / Round Rock / Spangenberg NPE rosters. Jazz is a frequent plaintiff, but as an operating drug maker suing generic and competitor filers (e.g., Jazz v. Avadel, D. Del. 1:21‑cv‑00691) — that is operating‑company assertion, not NPE conduct.

3. Repeat correspondent across the chain — unclear / not captured. The correspondent of record for the 2020‑12‑11 and 2021‑05‑05 entries could not be extracted, so no recurrence finding is supportable. Because there is no LLC‑to‑LLC chain, this signal is low‑relevance here even if a repeat counsel exists.

4. Cascading transfers — not present. Two events over ~5 months, one of which is a lien rather than a sale; no shared‑correspondent, common‑principal LLC cascade.

5. Pre-litigation transfer — not present (timing noted). The inventor→Jazz assignment was recorded 2020‑12‑11, roughly five months before Jazz's first infringement complaint naming the sustained‑release patents (filed May 13, 2021, D. Del. 1:21‑cv‑00691). The timing technically falls inside the six‑month window, but this is the ordinary inventor vesting into the original assignee, not an arm's‑length transfer to an asserter to manufacture standing or venue. Not a troll signal.

6. Bankruptcy fire-sale — not present. No Chapter 7/11 proceeding and no judicial patent sale appears; Jazz is a going concern.

7. Privateering — not present. Jazz asserts the patent in its own name against a direct commercial rival (Avadel/Lumryz); there is no intermediary NPE asserting on Jazz's behalf, and no SEC‑disclosed privateering arrangement.

8. Defensive aggregator (anti‑NPE) — not present. The chain does not terminate at RPX, AST, LOT, Unified, or OIN; ownership remains with the operating company.

Verdict

Operating-company assertion.

Justification: The only recorded ownership events are the 2020‑12‑11 inventor→Jazz Pharmaceuticals, Inc. assignment and the 2021‑05‑05 security interest to U.S. Bank National Association (a collateral grant across Jazz entities, not a transfer). Jazz is a public operating pharmaceutical company that markets the oxybate products and asserted this patent family as plaintiff against a direct competitor (Avadel, D. Del. 1:21‑cv‑00691, first complaint May 13, 2021; Federal Circuit appeals 23‑1186 and 24‑2274), with Avadel's mirror‑image antitrust suit at 1:22‑cv‑00487. None of the eight NPE indicators is present on this record.

Verification link: Assignment Center search by patent number at https://assignmentcenter.uspto.gov/ (mirror: https://assignment.uspto.gov/patent/index.html); Google Patents legal events at https://patents.google.com/patent/US10966931/en.

Data gaps I will not paper over: the specific reel/frame numbers and the correspondent of record for the two entries above were not present in the sources I could retrieve; confirm them on the Assignment Center before relying on this chain for a due‑diligence or standing memo.

I'll research the prior-art citations for US 10,966,931 directly from patent databases.

Let me pull the actual citation lists from patent databases.

I found a key source — the litigation appendix shows the "References Cited" section. Let me drill into the actual citation list.

Prior Art of US 10,966,931 — Citation Analysis

0. Scope, sourcing, and an important limitation (read first)

Patent identified (literal): US 10,966,931 B2 (the ID "10966931" = 10,966,931 — no auto-correction), Controlled Release Dosage Forms for High Dose, Water Soluble and Hygroscopic Drug Substances, App. No. 17/012,831, filed Sep. 4, 2020, granted Apr. 6, 2021, inventors Clark Allphin & James Pfeiffer, assignee Jazz Pharmaceuticals, Inc. This matches the authoritative full text supplied in the prior sections, so I did not return results for similar numbers (e.g., not the sibling 10,959,956, and not the reissue-listed 10,996,931).

⚠️ Disclosure of a hard limitation: I reached my tool-call limit before I could pull the verbatim face-page "(56) References Cited" list printed on the '931 patent itself. Consequently:

• The list in Section 2 below is the face-page citation list of the sibling US 10,959,956 B2 (same family, same specification, same examiners/art unit, prosecuted in parallel), which I retrieved from the CourtListener record of Jazz v. Avadel (Exs. 1–15, Dkt. 266, Att. 1, D. Del. 1:21-cv-01138). I use it as a proxy for the '931 list because the two patents share an identical specification. I have not confirmed the lists are identical, and I flag every item accordingly.
• Section 3 lists prior art that the '931 specification itself names and discusses (this I verified directly from the authoritative patent text).
• Section 4 gives the § 102 analysis, which is necessarily provisional because (per the prior section) the verbatim claim text was never retrieved and the claim 1/claim 8 wording is a reconstruction.

Where I cannot verify a reference's subject matter within my tool budget, I say so rather than guess.

1. What the patent's own record says is the closest art

Google Patents' "Prior art keywords" for the '931 — "controlled release · hydroxybutyrate · gamma · drug · hours" — and the face of the document point to a small, tightly-focused prior-art field: GHB/oxybate formulations, controlled-release coating technology, and the Liang GHB pulse-release family. The prosecution history quoted in the Jazz v. Avadel joint claim-construction appendices confirms the Examiner's primary reference was Liang et al., US 2006/0210630 A1, against which Jazz repeatedly argued (and submitted an inventor declaration distinguishing Liang as pH-dependent/delayed rather than sustained release).

2. Face-page "(56) References Cited" — U.S. Patent Documents

(Proxy list from sibling US 10,959,956 B2; month/year as printed in the OCR'd record. Descriptions are mine and are flagged where unverified.)

2a. The single most relevant reference — the Liang GHB family

2b. GHB/oxybate formulation and salt art

2c. GHB distribution / prescription-management art (non-formulation)

2d. General controlled-release platform / coating art (state of the art)

§ 102 exposure: none anticipated — these are matrix/coating/PK platform disclosures, cited to show the ordinary skill level. They are § 103 combination art (e.g., ethylcellulose/methacrylate functional coats, pore formers, water-soluble-drug matrices).

⚠️ Post-priority-date problem: several of the 2014–2016 publications postdate the '931's effective filing date (Mar. 24, 2011 or provisional Mar. 24, 2010). They are § 102 art only if their earlier effective U.S. filing date reaches back before that date (pre-AIA § 102(e)); otherwise they are not § 102 references at all. This needs to be checked reference-by-reference against each item's priority chain.

2e. Same-family member (not prior art)

US 2014/0171506 A1 (Allphin et al.), ~Jun. 19, 2014 — this is an Allphin/Jazz family publication (the '931's own specification line), listed in the IDS. It is not § 102 art against the '931 (same inventors/disclosure); I list it only so it is not mistaken for third-party art. (Consistent with the family tree in the prior section: WO 2011/119839, US 2014/0171506, US 2018/0318222, US 2020/0113840 are all Jazz family members, not prior art.)

3. Prior art named in the '931 specification itself (verified from the authoritative text)

§ 102 exposure of these: none — they are background/mechanistic (epidemiology, PK, synthesis) and support the state of the art for the method-of-treatment and PK-profile limitations now recited in the '931, rather than the dosage-form architecture.

4. § 102 anticipation analysis (provisional, per reconstructed claims)

Applying the reconstructed claim 1 (independent method: IR + SR GHB portions; SR = core + functional coating; coating = methacrylic acid–methyl methacrylate copolymer at ~20–50 wt% of the coating; ~500 mg–12 g GHB; >~40% released by about 4–6 h in USP App. 2, DI water, 37 °C, 50 rpm) and dependent limitations (IR = 10–50 wt% of total drug; ≥30% at 1 h / >90% at 8 h; salt = Ca/Li/K/Na/Mg):

Bottom line on anticipation: On the reconstructed claim language, no cited reference fully anticipates claim 1 or claim 8 of the '931 in a single reference. The art is, however, fatal-in-aggregate on § 103 grounds — Liang supplies IR+CR GHB with a methacrylate-copolymer coating, and the CR-platform references supply the coating-composition (20–50 wt% copolymer, pore former, plasticizer) and dissolution-profile integers.

5. Open items I could not resolve (do not treat as settled)

1. The '931's actual face-page (56) list was not retrieved verbatim. Everything in § 2 is a proxy from sibling '956. Confirm the exact '931 list before relying on it.
2. Verbatim claim text of the '931 remains unretrieved (see the prior section's flag). Until it is pulled, the "which claim does it anticipate" mappings above are provisional.
3. The IPR / unpatentability thread. The prior section flagged (unverified, secondary-source) that the Federal Circuit No. 23-1186 affirmed unpatentability of five patents expressly listing US10966931B2. If accurate, the petition/grounds art in that proceeding — not the face-page citations — would be the legally operative "most relevant prior art." I could not obtain that record.
4. Priority dates of the 2014–2016 cited publications must be individually checked against the '931's Mar. 24, 2011 / Mar. 24, 2010 dates before treating any as § 102 art.
5. Two Klosa numbers (4,393,236 and 4,393,296) both cited for GHB-salt production — preserved literally, not corrected.

If you want, in a follow-up I can target (a) the verbatim '931 claim set, (b) the exact printed (56) list, or (c) the IPR grounds — each of which would convert the provisional analysis above into a verified § 102/§ 103 mapping.

I'll ground this obviousness analysis in real prior-art references. Let me search for the key references and the state of the art.

Let me pull the key GHB-specific prior art (Conte) and verify the actual claim language of the '931 patent.

I hit my tool-call limit, but I retrieved enough authoritative prior-art material to complete a grounded §103 analysis. Note: I could not retrieve the verbatim claim text of the asserted claims (consistent with the earlier sections), so the element-by-element mapping below rests on the claim scope reconstructed in the earlier "Independent claims — overview" section and on the Avadel litigation record. I flag every inference.

Obviousness Analysis — US 10,966,931 under 35 U.S.C. § 103

1. Governing framework

• Statute/standard: 35 U.S.C. § 103; KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (combinations of known elements according to known methods are obvious absent unexpected results; predictable use of prior-art elements; "obvious to try" where there is a finite number of identified, predictable solutions).
• Critical date: The '931 specification claims benefit of provisional 61/317,212 (Mar. 24, 2010) and app. 13/071,369 (Mar. 24, 2011). If the asserted claims are entitled to that date, prior art is limited to what was publicly available before Mar. 24, 2010/2011. ⚠️ This is contested: the D. Del. record shows a written-description attack (Avadel's expert argued the sustained-release patents do not describe how to determine GHB release from the sustained-release portion of an IR/CR formulation), which, if successful, would push the effective filing date to 2018–2020 and would admit Avadel/Flamel's own publications ('284, '062, '986) as prior art. I analyze both scenarios.
• POSA (typical, and I infer the parties did not materially dispute it): a formulation scientist with an advanced degree in pharmaceutics/chemical engineering and ~2–5 years' experience developing oral controlled-release solid dosage forms.

2. Claim scope being tested (per prior sections — paraphrased, not verbatim)

The earlier sections established that the '931 is a method-of-use patent whose asserted claims (1–6, 8–15) require, at minimum:

Internal contradiction to flag (obviousness-relevant): The specification repeatedly touts time-dependent, pH-independent release as the invention's advance over the "pH dependent" prior art (Liang). But the asserted claim recites a methacrylic acid–methyl methacrylate copolymer — an enteric, pH-triggered polymer. That tension matters below: to the extent a POSA reads the claim's functional coating as a pH-triggered enteric coat, Liang's own enteric-coated GHB formulations are squarely on point.

3. Prior art of record

3a. GHB-specific references

R1 — Liang et al., US 2006/0210630 A1 ("Liang 2006"), publ. Sept. 21, 2006.
https://patentimages.storage.googleapis.com/49/fb/f1/cdc02554704913/US20060210630A1.pdf ; https://www.freepatentsonline.com/y2006/0210630.html

• "Oral pulse-release pharmaceutical dosage form containing an immediate release component of gamma-hydroxybutyric acid, and one or more delayed/controlled release components."
• Explicitly aims at once-nightly dosing ("a twice-nightly dosage regimen can be reduced to a single dose").
• The CR component is a GHB IR core + barrier coat + pH-sensitive enteric release coat (Eudragit L100-55, FS30D).
• Teaches that GHB absorption is region-specific and greater in the upper GI, i.e., motivates releasing drug high in the GI — the same rationale the '931 spec uses to justify finishing release in ~4–10 h.
• Discloses ethylcellulose-coated GHB cores (Liang Fig. 6) and dosing ranges of 4.5–9 g.
• This is the disclosure Jazz's specification distinguishes ("Liang ... function in a pH dependent manner").

R2 — Conte et al., US 5,594,030 (issued Jan. 14, 1997) / EP 0635265 A1 (1995).
https://storage.courtlistener.com/recap/gov.uscourts.njd.[478299](/patent/478299)/gov.uscourts.njd.478299.244.2.pdf (quoting Conte 4:3–6) ; cited in US 5,594,030's own summary of GHB dosage forms

• "Controlled release pharmaceutical compositions of gamma hydroxybutyric acid salts consisting of a nucleus in the form of granulates or tablets which comprises GHB and a cellulosic matrix, wherein the drug substance is released within 7 to 8 hours."
• Teaches GHB salts "preferably selected from the group consisting of sodium, lithium, potassium, magnesium and calcium salts."
• Notably, Conte is itself a GHB controlled-release tablet patent, and the Liang specification cites it as known art.

R3 — WO 2006/053186 to Frucht (May 18, 2006) — sodium oxybate for hyperkinetic movement disorders; supports the method-of-treatment prong (and is cited in the '931 Background). https://patentimages.storage.googleapis.com/6f/73/a8/f581204e120e9c/US20200113840A1.pdf

R4 — US 4,393,236 (GHB salts) and US 4,393,296 (Klosa) ("Production of Nonhygroscopic Salts of 4-Hydroxybutyric Acid") — both cited in the '931 specification; bear on the salt-selection limitation and on the hygroscopicity problem.

3b. General controlled-release coating art (the "known elements")

R5 — Controlled-release film-coat art: release control substance + pore former. E.g., US 9,387,166 / US 2014/0377349 (oxycodone CR):
https://patents.justia.com/patent/[9387166](/patent/9387166)

• "A preferred excipient for use with the release control substance ... is a plasticizer and/or a pore builder [pore former]"; "In particular, hydroxypropyl cellulose (HPC) is used as pore former."
• Release-control layer ~ "40 to 80 wt. % release control substance, 1 to 25 wt. % pore builder, 1 to 25 wt. % plasticiser" — i.e., a polymer-plus-pore-former rate-limiting film.
• Also teaches resistance to alcohol dose-dumping as a known design objective.

R6 — Coating of water-soluble drug particles with cellulosic/methacrylate polymers. US 9,415,048:
https://patentimages.storage.googleapis.com/91/aa/be/3eb5cc3ebd909f/US9415048.pdf

• "The coating material is preferably selected from ... ethylcellulose (e.g., SURELEASE®) ... acrylic polymers such as polyacrylates, polymethacrylates and copolymers thereof ... and, optionally, a pore former."
• "The release-controlling coating for a given bead population may be controlled by at least one parameter of the ... coating" — confirming coat weight/thickness tuning is routine.

R7 — Polymethacrylate/enteric coating benchmarks. Eudragit L100-55 (methacrylic acid–ethyl acrylate 1:1) and Eudragit S100 (methacrylic acid–methyl methacrylate 1:2) were, by 2010, standard, commercially catalogued enteric polymers. Their interchangeability is confirmed by the fact that Avadel's own later patent, US 10,272,062 (claim 33–34), recites "methacrylic acid and methyl methacrylate copolymers" and "methacrylic acid and ethyl acrylate copolymers" side-by-side as alternative "polymer[s] carrying free carboxylic groups."
https://patentimages.storage.googleapis.com/64/ae/92/79fcdc29cbd25b/US10272062.pdf

R8 (conditional/alternative-date scenario only) — Avadel/Flamel publications US 2018/0021284 A1, US 10,272,062, US 10,952,986.
These disclose an IR fraction + modified-release fraction of sodium oxybate, where the MR particles are coated with methacrylic acid–methyl methacrylate copolymer (Eudragit S100) + methacrylic acid–ethyl acrylate copolymer (L100-55), dosed at 4.5–9 g, and — critically — the '284 publication (Table 2d) reports dissolution in DI water, USP App 2, 37 °C, 50 rpm of ~58% at 4 h and ~92% at 6 h, which is the very dissolution protocol and profile the '931 claims recite.
https://storage.courtlistener.com/recap/gov.uscourts.ded.75471/gov.uscourts.ded.75471.357.0.pdf (expert report discussing the '284 Publication at Example 1, Table 2d, Fig. 5)
⚠️ These post-date March 2011; they are prior art only if the '931 claims are denied the 2010/2011 priority date.

4. Obviousness combinations

Combination A (primary): Liang 2006 + Conte, further in view of R5/R6 coating art

Where every element is found:

• IR + SR portions of GHB → Liang 2006 (expressly an IR component plus delayed/controlled-release GHB particles).
• SR "core + functional coating deposited over it" → Liang's IR core + barrier + enteric release coat; Conte's matrix tablet; R6's coated particles.
• Functional coating with a rate-controlling polymer + pore former → R5 (ethylcellulose + HPC pore former), R6; and Liang's own EC-coated core.
• GHB dose 500 mg–12 g → Liang (4.5–9 g) and Conte.
• GHB salt selected from Ca/Li/K/Na/Mg → Conte 4:3–6 verbatim; R4.
• Release >40% by 4–6 h in USP App 2/DI water/50 rpm → Conte's "released within 7 to 8 hours" cellulosic-matrix profile, and Liang's dissolution figures; the 4–6 h window is within the ordinary range achieved by tuning coat weight/pore-former (R6; and the '931 specification itself concedes these are the routine "knobs": "the release rate ... may be adjusted by modifying the thickness or weight of the functional coating," "increasing the amount of a given pore former ... increased ...", etc., at the spec level).
• Method of treating narcolepsy / once-nightly dosing → Liang 2006 (express purpose); R3 for sodium oxybate's therapeutic use.

Why a POSA would have combined them:

1. Same field, same problem, same drug. Liang and Conte are both directed to oral GHB dosage forms and both target reduced dosing frequency. KSR rationale (A): combination of known elements according to known methods to yield predictable results.
2. Explicit motivation in Liang — its stated object is to convert twice-nightly GHB to a single dose, exactly the medical problem §103 motivation requires.
3. Known pharmacokinetic defect of GHB — ~45-min plasma half-life (Borgen et al., cited in the '931 spec) and rapid clearance below 10 µg/mL within ~4 h — supplies a strong reason to add a sustained-release component, and Conte teaches a CR GHB matrix that works.
4. Known problem with pH-dependent GHB release — the '931 spec itself explains that pH-dependent systems suffer from gastric-emptying variability. A POSA optimizing Liang would be motivated toward a diffusion-/time-controlled functional coating (the ethylcellulose/pore-former films of R5/R6) or toward routine selection among methacrylic copolymers.
5. Routine optimization — coat weight, pore-former level, and polymer grade are, as R5/R6 and the '931 spec confirm, conventional variables. Choosing values that yield >40% at 4–6 h is a predictable result of a finite, identified set of options (KSR "obvious to try").

Combination B: Liang 2006 (or Conte) + Eudragit/methacrylate coating art (R7), to meet the "methacrylic acid–methyl methacrylate copolymer 20–50 wt%" limitation

• Liang expressly uses methacrylic acid copolymers (Eudragit L100-55). Substituting the homologous methacrylic acid–methyl methacrylate copolymer (Eudragit S100) is a simple substitution of one known element for another (KSR rationale B) to adjust the pH trigger — the classic, documented reason a formulator selects among the L/S/FS grades. Avadel's own family (R8) confirms these two copolymers are treated as interchangeable in this exact context.
• The 20–50 wt% coating proportion is a result-effective-variable selection; R8 (Avadel) independently recites "coating is 10 to 50% of the weight of the particles," and R5 teaches release-control layers at 40–80 wt% polymer — so the claimed window is squarely conventional.
• ⚠️ Caution: If the asserted claim truly requires a pH-independent functional coating, then the Liang-derived pH-triggered methacrylate combination is more complicated, but the claim text contradicts the specification on this point (see §2). The most defensible reading — the one the litigation adopted (plain meaning of "sustained release portion") — is that the coating is a rate-limiting functional coat, and both pH-triggered (Liang) and diffusion-controlled (R5/R6) coatings qualify.

Combination C (alternative-date scenario): R8 (Avadel/Flamel '284 / '062 / '986) alone or with Liang

If the claims are not entitled to March 2010/2011 (because of the written-description defect the district court examined), then Avadel's own publications anticipate or render obvious the asserted claims: they disclose IR + MR sodium oxybate fractions, methacrylic acid–methyl methacrylate copolymer MR coatings, 4.5–9 g doses, and dissolution in DI water / USP App 2 / 50 rpm yielding 58% at 4 h and 92% at 6 h — matching the recited profile. This is the scenario that Avadel advanced in the litigation (its expert opined the '284 publication "discloses the recited GHB release from the sustained release portion").

5. Anticipated Jazz rebuttals and how they cut

6. Bottom line

Under the reconstructed claim scope, the asserted claims of US 10,966,931 would likely be prima facie obvious over Liang 2006 in view of Conte (both GHB-specific, both same field and same problem), further in view of the routine ethylcellulose/pore-former and polymethacrylate coating art (R5–R7) for the functional-coat and methacrylate limitations, with R3 supplying the method-of-treatment prong. The motivations are strong and textual (Liang's express once-nightly goal; GHB's short half-life; GHB's upper-GI absorption; the known gastric-emptying variability of pH-dependent systems), and the remaining claim parameters (coat weight, pore-former level, polymer grade, dose, salt, dissolution window) are result-effective variables within a finite, identified set. Secondary considerations (bioavailability, Cmax:Cmin, alcohol resistance) are the principal avenue for rebuttal but are weakened by (i) the dependent-claim placement of the PK limitations and (ii) the parties' own contradictory USPTO statements about the predictability of GHB formulations.

If the claims are denied the 2010/2011 priority date, the obviousness case becomes far stronger: Avadel/Flamel's own '284/'062/'986 publications disclose the IR+MR methacrylate-coated sodium oxybate formulation with a matching DI-water/USP-App-2/50-rpm dissolution profile, making the claims anticipated or at least plainly obvious.

7. Explicit uncertainties / caveats

1. Claim text is paraphrased. I could not retrieve the verbatim asserted claims; the element mapping above depends on the reconstruction in the earlier sections. Confirm against the issued claim set before relying on it.
2. Dependent-claim scope unverified — I have not confirmed which of Cmax/Cmin, ≥10 µg/mL, dosing-timing, and salt-selection limitations sit in which claims.
3. Priority-date determination is the pivot for whether R8 (Avadel/Flamel) qualifies as prior art; this turns on the written-description issue the district court examined, which I have not read in full.
4. "By about 4 to about 6 hours" — I rely on the earlier section's report of the parties' agreed construction (plain-and-ordinary meaning; "any point prior to ~4 h or ~6 h") rather than the court order itself.
5. I did not independently verify R2's (Conte's) full disclosure from the primary patent document — the quoted material comes from how the '931/Conte family and the N.J. brief characterize it. Confirm from US 5,594,030 directly.
6. The internal contradiction between the specification's "time-dependent/pH-independent" theme and the claim's methacrylic acid–methyl methacrylate (pH-triggered) limitation is my own observation and should be confirmed against the as-issued claim language.