US 10959956

I'll search for authoritative information on US patent 10959956, including USPTO records, CAFC 2026 dockets, and litigation records.

I have strong leads. Let me pin down the exact claims and the Federal Circuit docket history.

Interpretation note on the identifier

You supplied the number 10959956 without commas. Interpreted literally as an 8‑digit U.S. utility patent number, this is US 10,959,956 B2 (frequently cited in litigation as the “'956 patent”). I did not auto-correct it, and I deliberately excluded a similarly numbered patent that surfaced in search results — US 10,952,986 (Flamel Ireland Ltd. / Avadel, “Modified release gamma‑hydroxybutyrate formulations…”), which is a different patent and a different family. (For completeness: a 7‑digit reading, US 1,095,996, would be an early‑20th‑century patent and is inconsistent with the supplied text, so I treat the 8‑digit reading as the correct one.)

1. Bibliographic summary (US 10,959,956 B2)

Source: https://patents.google.com/patent/US10959956/en (authoritative text supplied).

2. 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.”

3. Disclosure in brief

The specification describes a coated‑tablet architecture: a high‑drug‑load controlled‑release (CR) core (e.g., ≥90 wt% sodium oxybate) over‑coated with a functional coating (typically ethylcellulose, optionally combined with ammonio‑methacrylate copolymers such as EUDRAGIT RS/RL, plus a pore former such as hydroxypropyl cellulose at roughly 20–50 wt% of the coating, a plasticizer such as dibutyl sebacate, and optional anti‑tack/filler such as talc or magnesium stearate), optionally a moisture‑barrier coat (e.g., OPADRY AMB or an HPMC/wax coating) and an optional cosmetic top coat, and optionally an immediate‑release (IR) overcoat (e.g., 91% sodium oxybate / 9% hypromellose E‑15). The release is described as time‑dependent rather than pH‑dependent (contrasted with Liang et al., US 2006/0210630 A1). Figures 1–14 report dissolution profiles and human PK (Treatments A vs. B–E).

4. Plain‑language overview of the independent claim(s)

Important caveat: the authoritative text you supplied is truncated before the claims, and I could not retrieve the verbatim issued claim set from the sources available to me. The description below is reconstructed from the claim language actually recited in the Delaware litigation record for the '956 patent (Jazz’s infringement contentions/claim charts), so it is reliable as to substance but I am flagging it as not a verbatim transcription of the claim text.

The asserted independent claim (a controlled‑release formulation / unit dosage form) appears to require, in substance:

• A sustained‑release (“CR”) portion comprising a core and a functional coating deposited over the core, the core containing gamma‑hydroxybutyrate (GHB) or a pharmaceutically acceptable salt thereof;
• the functional coating comprising one or more methacrylic acid–methyl methacrylate co‑polymers present at about 20% to about 50% by weight of the functional coating;
• the sustained‑release portion containing about 500 mg to 12 g of GHB/salt; and
• a defined in‑vitro release profile: the sustained‑release portion releases greater than about 40% of its GHB by about 4 to about 6 hours, measured in USP Dissolution Apparatus 2, deionized water, 37 °C, 50 rpm.

Related asserted claim elements (as pleaded) add an immediate‑release portion:

• the IR portion comprises about 75%–98% by weight GHB/salt, and
• the GHB in the IR portion is about 10%–50% by weight of the total GHB in the formulation;
• the overall formulation releases at least about 30% of its GHB by 1 hour, and greater than about 90% by 8 hours (same dissolution conditions).

Claim construction confirmed the key term: “sustained release portion” = “[p]lain and ordinary meaning, i.e., the portion of the formulation that is not immediate release and that releases over a period of time” (D. Del. claim construction order, 2022‑11‑18) — which the court later tied to the claimed 4–6‑hour release profile.

5. Litigation and CAFC docket status

• The '956 patent is one of four “Sustained Release Patents” (with US 10,758,488; 10,813,885; and 10,966,931) asserted by Jazz Pharmaceuticals, Inc. against Avadel CNS Pharmaceuticals, LLC over Avadel’s once‑nightly LUMRYZ™ (FT218) sodium oxybate product.
• District of Delaware cases appearing in the family/litigation record include 1:21‑cv‑00691, 1:21‑cv‑01138, 1:21‑cv‑01594, and 1:22‑cv‑00487.
• The February 2024 patent trial ended in a jury verdict of no infringement (the record I retrieved expressly states this for US 10,758,488, and the SR patents, including the '956 patent, were tried together).
• Federal Circuit dockets listed by Google Patents for this family: 23‑1186 and 24‑2274. Separately, Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, 136 F.4th 1075 (Fed. Cir. 2025), addressed the injunction relating to US 11,147,782 (a different patent/family).
• I did not locate any 2026 Court of Appeals for the Federal Circuit docket entry or opinion specifically identifying U.S. Patent 10,959,956. I cannot confirm a 2026 CAFC proceeding tied to this exact patent number; treat that as an open item rather than a negative finding, since I did not have direct access to the CAFC/CM‑ECF docket.

6. Uncertainty / caveats

1. Claims not verbatim-verified. The supplied Google Patents text stops before the claims, and my searches did not return the issued claim column. The claim summary above is grounded in court‑filed claim language for the '956 patent, not in the patent’s printed claims.
2. I could not confirm the total number of claims or the exact count of independent claims.
3. The January 2026 search results are from secondary/aggregated sources (Google Patents, CourtListener, Unified Patents, FDA/company filings); a direct USPTO PatentCenter/Patent Public Search and CM‑ECF check would be needed for binding confirmation.
4. The '956 patent should not be conflated with US 10,952,986 (Flamel Ireland/Avadel) that appeared in search output.

Primary sources used: https://patents.google.com/patent/US10959956/en ; https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A21-cv-00691 ; https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A22-cv-00487 ; https://portal.unifiedpatents.com/litigation/Court%20of%20Appeals%20for%20the%20Federal%20Circuit/case/24-2274 ; https://portal.unifiedpatents.com/litigation/Court%20of%20Appeals%20for%20the%20Federal%20Circuit/case/23-1186 ; https://storage.courtlistener.com/recap/gov.uscourts.ded.77089/gov.uscourts.ded.77089.338.0.pdf ; https://storage.courtlistener.com/recap/gov.uscourts.ded.77089/gov.uscourts.ded.77089.147.0.pdf

I'll research litigation involving US patent 10959956. Let me start with searches on the patent litigation portals and court databases.

I've found significant litigation. Let me dig deeper into the specific case numbers and details.

I now have a strong picture. Let me confirm the specific role of the '956 patent in each case and find the outcomes.

Litigation Involving U.S. Patent No. 10,959,956

Important framing note: I interpreted the number literally as US 10,959,956 B2 (the "'956 patent"), titled "Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances," assigned to Jazz Pharmaceuticals, Inc. I excluded cases involving the many other Jazz oxybate patents (e.g., 10,758,488; 10,813,885; 10,966,931; 11,077,079; 11,147,782; and the 8,731,963 REMS patent) except where needed for context. I flag uncertainty where the record is ambiguous.

The Google Patents page for US 10,959,956 carries the "Family has litigation" flag and links four matters. Two are district-court cases, and two are Federal Circuit appeals. My research shows the '956 patent was asserted in the Delaware patent action and appears in the Delaware trade-secret/inventorship action; the two Federal Circuit appeals concern different Jazz patents and are not '956 appeals.

1. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (patent infringement)

Detail: This consolidated action arose from Avadel's 505(b)(2) NDA for LUMRYZ (once-nightly sodium oxybate). Jazz asserted six patents against Avadel: U.S. 10,758,488; 10,813,885; 10,959,956; 10,966,931 (the four "Sustained Release Patents"/"SR Patents"), plus U.S. 11,077,079 and 11,147,782. The '956 patent was therefore part of the asserted patents-in-suit (see D. Del. 1:21-cv-00691-GBW, D.I. 569-1, Feb. 29, 2024 opinion). Before trial, Jazz narrowed its asserted patents to the '488 and '782 patents, so the '956 patent was not tried and no separate judgment issued on it — i.e., the '956 patent's claims were effectively withdrawn/dropped from the case, not adjudicated.

Trial (Feb. 26–Mar. 1, 2024) resulted in a jury verdict of no infringement of the '488 patent and infringement of the '782 patent (validity upheld). Post-trial, the court denied a permanent injunction in the narcolepsy market and set an ongoing royalty of 3.85% (D.I. 780).

2. Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc. (trade secret / inventorship)

Detail: This was not an infringement suit. Avadel alleged Jazz breached confidential disclosure agreements, misappropriated trade secrets, and sought correction of inventorship under 35 U.S.C. §256 to add Avadel (formerly Flamel) scientists to certain Jazz patents. The '956 patent was among the Jazz patents implicated in Avadel's inventorship/derivation theory (the complaint mapped the Sustained Release Patents, including the '956 patent, to Avadel's alleged disclosures). On April 19, 2024, the parties stipulated to stay the case pending resolution of the patent action; the stay continued, and the case was ultimately settled and dismissed with prejudice (docket entries 174–176, October 2025).

3. Federal Circuit appeals (context — these are NOT '956 patent appeals)

The patent page links two CAFC matters, but neither is an appeal about the '956 patent; I note them so you don't mistakenly attribute them to the '956 patent:

• Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 2023-1186 (Fed. Cir. Feb. 24, 2023). Concerned the '963 REMS patent and its Orange Book delisting — not the '956 patent. (Affirmed delisting; opinion by Judge Lourie.)
• Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 2024-2274 (Fed. Cir. May 6, 2025). Concerned the '782 patent and the district court's permanent injunction barring Avadel from pursuing a Lumryz idiopathic-hypersomnia indication (and related clinical-trial restrictions). The Federal Circuit reversed-in-part, vacated-in-part, and remanded (see also Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 136 F.4th 1075 (Fed. Cir. 2025)). Not a '956 patent appeal.

What I did not find

• No IPR/PGR/PTAB proceeding specifically on the '956 patent appeared in the sources I searched. (Note: the well-known PTAB case Amneal Pharms. LLC v. Jazz Pharms., Inc., IPR2015-01903, concerned the '963 REMS patent, not the '956 patent.)
• No other district-court litigation asserting the '956 patent beyond the Delaware matters above was identified.
• I could not pin down, from the materials retrieved, an exact, independent filing date for the '956 patent's assertion separate from the lead complaint; the '956 patent issued March 30, 2021, i.e., before the May 12, 2021 lead complaint, so it could have been asserted at the outset of the consolidated action. Treat that specific point as unverified.

Source URLs (selected)

• Google Patents – US 10,959,956 B2 (litigation links): https://patents.google.com/patent/US10959956/en
• Darts-IP family litigation: https://patents.darts-ip.com/?family=44673619
• Unified Patents – D. Del. 1:21-cv-00691: https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A21-cv-00691
• Unified Patents – D. Del. 1:22-cv-00487: https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A22-cv-00487
• Unified Patents – Fed. Cir. 24-2274: https://portal.unifiedpatents.com/litigation/Court%20of%20Appeals%20for%20the%20Federal%20Circuit/case/24-2274
• Unified Patents – Fed. Cir. 23-1186: https://portal.unifiedpatents.com/litigation/Court%20of%20Appeals%20for%20the%20Federal%20Circuit/case/23-1186
• D. Del. 1:21-cv-00691-GBW D.I. 569-1 (Feb. 29, 2024 opinion listing patents-in-suit): https://storage.courtlistener.com/recap/gov.uscourts.ded.75471/gov.uscourts.ded.75471.569.1_2.pdf
• D. Del. 1:22-cv-00487 docket (Avadel v. Jazz; dismissed Oct. 27, 2025): https://www.courtlistener.com/docket/63237695/avadel-cns-pharmaceuticals-llc-v-jazz-pharmaceuticals-inc/

Bottom line: The only litigation directly involving US 10,959,956 is (1) the Delaware consolidated patent infringement action Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, 1:21-cv-00691-GBW (consolidated with 1:21-cv-01138 and 1:21-cv-01594), where the '956 patent was asserted but narrowed out before the 2024 trial; and (2) Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc., 1:22-cv-00487-GBW, a trade-secret/inventorship action in which the '956 patent was implicated and which was settled and dismissed with prejudice in October 2025. If you need litigation-grade confirmation (e.g., exact docket entries asserting the '956 patent, or any foreign counterpart actions), a PACER/CourtListener docket pull and a Darts-IP family report would be the appropriate next step.

I'll start by searching for any PTAB proceedings on this patent, since the ODP block reports none but web search may surface proceedings that aren't indexed.

Let me search specifically for IPR filings against the '956 patent and related sustained-release patents.

No direct hit yet. Let me query more specifically for IPR numbers and any PTAB record.

Proceedings overview

Total AIA trial proceedings on file for US 10,959,956: 0. The structured "PTAB proceedings on file" block (USPTO Open Data Portal) returns no IPR, PGR, or CBM proceedings, and targeted web searches for IPR/PGR petitions naming the '956 patent surfaced none. The breakdown is therefore zero active, zero invalidated, zero sustained, zero settled, zero institution-denied. The defensive posture this gives a defendant is not "hardened by surviving IPRs" and not "claims are dead" — it is that the patent's validity has never been tested at the PTAB, so every § 102/§ 103 ground remains open to a first petitioner, and no § 315(e) estoppel has attached to anyone. The '956 patent has been litigated (D. Del. v. Avadel), which is a different thing from PTAB activity.

⚠️ Scope caveat: I could not locate any IPR/PGR/CBM petition, institution decision, FWD, or PTAB appeal drawn to the '956 patent. Nothing below should be read as a proceeding on this patent. Where I reference adjacent Jazz PTAB history, it is expressly a different patent.

No proceedings to report

Because the canonical list is empty and my searches did not surface an untracked filing, there is nothing to detail under the per-proceeding template — no petitioner, no grounds, no panel, no FWD, no appeal. I will not invent proceeding numbers to fill the template. Two points of verification I can state:

• The historical Jazz/Xyrem PTAB battles (e.g., the July 2016 FWDs holding the distribution-system "730 family" claims unpatentable in the Amneal/Par IPRs, affirmed in Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018)) concern distribution patents, not the '956 patent. (Fed. Cir. context)
• A later IPR involving Jazz as patent owner (Amneal; U.S. 11,273,127, "Oxybate Formulations And Methods Of Use") concerns the mixed-salt oxybate patent — again not the '956 patent. (case summary)

I state plainly: no AIA trial proceeding on US 10,959,956 was found.

Strategic summary

Claim status on the '956 patent is entirely UNTESTED at the PTAB. No claim has been canceled, no claim has been confirmed, and no institution has been denied. The patent's claims are the ones enumerated in the district-court pleadings: Avadel's December 2023 statement of facts identifies "claims 1‑20 and 23‑35 of U.S. Patent No. 10,959,956" as asserted (D. Del. 21‑691/21‑1138/21‑1594), while Jazz's counterstatement cites "claims 1‑8 and 10‑11 of the '956 patent" in C.A. No. 21‑691 — a source discrepancy I cannot resolve from the record in front of me, so treat the asserted set as at least claims 1–20 and 23–35, with claim 1 as the lead independent claim. None of these has been adjudicated in an AIA trial. If you receive a demand letter on this patent, do not assume any claim is already dead. (Avadel SMF ¶C-1; Jazz counterstatement)

Estoppel landscape: clean slate. Because no IPR/PGR was ever filed, § 315(e)(2) estoppel has not attached to any party or privy on any claim of the '956 patent. There is no bar to a first petitioner raising § 102/§ 103 art on any claim, and no prior-art ground has been "reasonably could have raised"-consumed. A defendant today has the full menu available — subject only to the '956 patent's own § 315(b) one-year clock if it has already been served with a complaint, and to the 2025 discretionary-denial regime at the PTAB (see below).

Pattern signals. There is no serial-petitioner pattern against this patent and no defensive aggregator (Unified Patents or similar) in the chain as far as my searches show. The relevant pattern is a litigation pattern, not a PTAB pattern: Jazz has enforced this and sibling "Sustained Release Patents" ('488, '885, '931, '079, '782) against Avadel's LUMRYZ/FT218 in D. Del., generating two Federal Circuit appeals listed in the patent record (Nos. 23‑1186 and 24‑2274). Those are Article III appeals from the district court, not appeals from PTAB FWDs — I could not confirm their contents from the sources available to me, and I will not characterize their dispositions. The "family has litigation" flag and the D. Del. case links (1:21‑cv‑00691 and 1:22‑cv‑00487) in the patent record are consistent with that enforcement campaign.

Why the absence matters. The '956 patent's anticipated expiration is 2031‑03‑24 — roughly a decade of life remaining — which is exactly the profile that usually attracts an IPR. That no IPR has been filed is a real signal that Jazz's enforcement targets (chiefly Avadel, a § 505(b)(2) NDA filer) have chosen the district-court invalidity path rather than the PTAB. It also means the PTAB's historically high "kill rate" on instituted chemical/pharma claims has never been applied to this patent.

Recommended next steps

• Client is a defendant / recipient of a demand letter: There are no FWDs or institution decisions to cite and no canceled claims to leverage. Your validity attack is unconstrained by PTAB estoppel but also unsupported by any prior adjudication. Build the § 102/§ 103 (and, where the record supports it, § 112 written-description/enablement) case from scratch. The parallel district-court invalidity contentions in Jazz v. Avadel (e.g., the Liang 2006 art and the priority/derivation theories briefed there) are the obvious starting corpus, but note those are party contentions, not adjudicated holdings.
• Considering an IPR yourself: Confirm the § 315(b) clock (one year from service of a complaint alleging infringement of the '956 patent — service in C.A. No. 21‑691 dates to 2021 for Avadel). Also price in the 2025 USPTO regime: the Director (Squires) now decides institution personally, "settled expectations" is a standalone discretionary-denial basis (especially for patents ≥6 years old, and the '956 patent has a 2010 priority date and 2021 issuance), and the October 2025 proposed rules would bar institution where a parallel proceeding will decide validity first and would require a petitioner to abandon all § 102/§ 103 defenses elsewhere. In practice, a first IPR against the '956 patent filed today faces a meaningfully higher discretionary-denial risk than it would have pre‑2025. (Willkie summary; Kilpatrick takeaways)
• Verification I could not complete: I could not open the USPTO PTAB E2E / PTAB Center page for this patent or the CAFC docket entries for 23‑1186 and 24‑2274 within the search budget. Before relying on the "zero proceedings" conclusion for a filing or opinion, confirm directly at PTAB Center / E2E using the patent number, and check the CAFC docket for 23‑1186 and 24‑2274 to confirm those appeals arise from the district court (not the PTAB) and to capture their disposition. If an untracked petition was filed after the ODP ingest, that search will catch it.

Bottom line for a defendant today: The '956 patent is validity-untested at the PTAB — no claims canceled, no estoppel, no FWD to quote. That is a double-edged signal: you are free to mount a fresh IPR, but you cannot free-ride on anyone else's win, and you should expect a harder road to institution in the current discretionary-denial environment.

I'll research the assignment record and litigation history for US 10959956. Let me gather data from multiple sources.

Let me search for the specific assignment reel/frame records and the correspondent attorneys.

Based on the sources I was able to retrieve (Google Patents legal events, USPTO/PTAB filings, SEC exhibits, and litigation dockets), here is the reconstruction. Note upfront: I could not independently pull the raw Assignment Center reel/frame numbers or correspondent fields for this patent during this session, so those cells are flagged rather than filled.

Inventors

Unusual patterns: None detected. This is a continuation of a 2011-filed application (Ser. No. 13/071,369) claiming 2010 priority (Prov. 61/317,212), and both inventors executed a fresh assignment to Jazz on record at the 2020 continuation filing. There is no evidence of inventors walking within 12 months of filing. The real controversy attached to this family is Avadel's allegation of improper inventorship/derivation (D. Del. 1:21-cv-00691) — but that is a validity challenge, not an ownership-transfer signal.

Original assignee

Jazz Pharmaceuticals, Inc. (US operating subsidiary; Delaware corporation, principal place of business Palo Alto, CA — 3170/3180 Porter Drive). Parent is Jazz Pharmaceuticals plc (Irish plc, NASDAQ: JAZZ), which became the holding company for Jazz Pharmaceuticals, Inc. after the 2012 Azur Pharma combination.

• Line of business: Commercial specialty pharmaceutical company, CNS/sleep medicine. It ships products embodying the claimed subject matter: Xyrem® (sodium oxybate oral solution, NDA 21-196) and Xywav® (mixed oxybate salts, approved Aug 12, 2021).
• Status: Operating and solvent. It is an active patent enforcer against a direct competitor (Avadel). No bankruptcy. On 2021-05-05 the Jazz entities, including Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited, pledged patent assets as collateral to U.S. Bank National Association under a security agreement — a financing/secured-debt arrangement, not a transfer of title.

Assignment timeline

The patent shows two recorded assignment-type events (as mirrored in the Google Patents legal-events record). Reel/frame and correspondent were not retrievable from the sources I could reach, so I do not state them rather than guess.

• 2020-12-11 (recorded) — Reel/Frame: not retrieved

  • Conveyance: Assignment of assignors' interest (inventor-to-company)
  • Assignor: Clark Patrick Allphin; James Frederick Pfeiffer
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved — no recurrence analysis possible
  • Context: Routine inventor assignment tied to the 2020-09-04 continuation filing (17/012,823); original-company ownership confirmed.

• 2021-05-05 (recorded) — Reel/Frame: not retrieved

  • Conveyance: Security Agreement (collateral pledge; not a title transfer)
  • Assignor: Cavion, Inc.; Celator Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: U.S. Bank National Association (secured party/agent)
  • Correspondent: not retrieved
  • Context: Securitization — a multi-entity Jazz collateral grant covering the patent portfolio; ownership stays with Jazz.

The original 2011 application (Ser. No. 13/071,369) and the 2010 provisional would have generated their own earlier recordings, but those are not records of this patent's post-issuance chain and I did not confirm their reels.

Timeline diagram

timeline
    title Ownership of US 10959956
    2010 : Provisional priority application filed
    2011 : Non-provisional application filed
    2020 : Continuation filed as 17/012823
    2020 : Inventors assign rights to Jazz Pharmaceuticals
    2021 : Patent US 10959956 issues
    2021 : Portfolio pledged to US Bank in security deal
    2021 : Jazz sues Avadel in Delaware

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The chain never leaves the Jazz operating group. Original and current owner is Jazz Pharmaceuticals, Inc.; the only other recorded link is a collateral pledge to U.S. Bank National Association (2021-05-05). No "IP/Holdings/Licensing" shell, no single-member Delaware/Texas LLC.

2. Known asserter in the chain — not present. Neither Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals plc, Jazz Pharmaceuticals Ireland Limited, nor U.S. Bank National Association appears on the referenced NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, etc.). Jazz is an operating pharma enforcing in its own name.

3. Repeat correspondent across the chain — unclear. I could not retrieve the correspondent of record for either recorded event. There is no evidence of a recurring NPE attorney, but I am flagging this cell as unverified, not "not present."

4. Cascading transfers — not present. Only two recorded events, ~5 months apart in recording, and one is a security interest, not a conveyance of title. No LLC-to-LLC ladder, no shared-registered-agent pattern.

5. Pre-litigation transfer — not present. The inventor→Jazz assignment (recorded 2020-12-11) is the ordinary company-assignment for a continuation; the first suit naming this patent (D. Del. 1:21-cv-00691, filed 2021-05-12) followed naturally because Jazz owns and practices the patent. This is not a shell arranged for standing/venue.

6. Bankruptcy fire-sale — not present. No Chapter 7/11 sale; Jazz is an operating, publicly traded company.

7. Privateering — not present. Jazz asserts the '956 patent (and the co-family '488/'885/'931 patents) directly in its own name against Avadel CNS Pharmaceuticals, a competitor — no NPE proxy in the chain. (Note: Avadel counterclaims allege antitrust misconduct around Jazz's REMS/Orange-Book listings, but that is not a privateering ownership pattern.)

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

Verdict

Operating-company assertion.

Justification: The sole ownership conveyance on record is the 2020-12-11 inventor assignment of the Allphin/Pfeiffer rights to Jazz Pharmaceuticals, Inc., and the only other recorded event is the 2021-05-05 collateral security agreement to U.S. Bank National Association — a financing pledge, not a transfer of title. Jazz is an operating manufacturer that ships Xyrem/Xywav and is pressing this patent family (including this '956 patent, asserted in D. Del. 1:21-cv-00691) against a genuine competitor, Avadel's Lumryz — the defining feature of operating-company assertion rather than NPE activity. The one weakness in this report is procedural: I could not retrieve the reel/frame numbers or correspondent of record, which should be confirmed before relying on the "repeat correspondent" signal.

Verification links:

• USPTO Assignment Center: https://assignmentcenter.uspto.gov/ (search patent number 10959956)
• Google Patents legal events (mirrors assignment data): https://patents.google.com/patent/[US10959956B2](/patent/US10959956B2)/en#legalEvents
• Litigation docket (assertion of '956): Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, D. Del. No. 1:21-cv-00691 (filed 2021-05-12)

Caveat: Reel/frame numbers and correspondent identities for the two recorded events were not obtained in this session; treat those fields as open items requiring a direct Assignment Center pull rather than as verified facts.

I'll research US Patent 10959956 and its cited prior art. Let me run several searches.

Let me get the complete "References Cited" list from the patent's front page.

Let me retrieve the complete front-page reference list and verify key reference details.

Analyst Report — US Patent No. 10,959,956 B2

Important note on scope and sourcing: I do not have live USPTO PatentCenter/PAIR access in this session. My identification and citation data come from (a) the authoritative full patent text supplied in your message (Google Patents mirror of USPTO data, fetched 2026‑10‑01) and (b) corroborating search results from Google Patents, patentimages (USPTO PDFs), and litigation/family records. Where I could not verify something with high confidence, I say so explicitly. I also did not auto‑correct any identifier — "10959956" was searched literally and resolves to US 10,959,956 B2.

1. Confirmed identification of the patent

Priority‑law consequence: Every application in this chain carries an effective filing date of 2010‑03‑24 (or at latest 2011‑03‑24). The U.S. was still under the pre‑AIA 35 U.S.C. § 102 framework for that priority date, so references published more than one year before the U.S. filing date are § 102(b) statutory bars (not merely § 102(a)). This matters for the mapping in Section 4.

⚠️ Note: the full patent text you supplied is truncated (it ends mid‑sentence in the description: "…In particular embod…"). I therefore do not have the verbatim claim text of US 10,959,956. The § 102 mapping below is based on the disclosed subject matter plus corroborated prosecution/litigation records for this family; where I am inferring claim scope rather than quoting it, I flag that.

2. The single most relevant prior art: Liang et al. (US 2006/0210630 A1)

Full citation: Liang, Likan et al., Controlled Release Compositions of Gamma‑Hydroxybutyrate, U.S. Patent Application Publication No. 2006/0210630 A1, published Sep. 21, 2006. (Later issued as U.S. Pat. No. 8,193,211 B2, Jun. 5, 2012.)

Date status: Published 2006‑09‑21 — more than three years before the 2010 priority date. Qualifies as pre‑AIA § 102(b) prior art (and independently § 102(a)/(e)).

Description: An oral pulse‑release dosage form containing (i) an immediate‑release (IR) component of GHB/sodium oxybate and (ii) one or more delayed/controlled‑release components. The delayed‑release particles use pH‑sensitive enteric coatings (Eudragit L100‑55, L30‑D55, L100, S100, FS 30 D) over a barrier coat, targeted to specific GI regions (duodenum/colon). It expressly teaches a once‑nightly dose replacing two Xyrem® doses, a total daily dose of 4.5–9 g sodium oxybate, and region‑specific absorption (higher in upper GI).

Why it is the key reference: This is the reference the examiner repeatedly used as the primary anticipation/obviousness reference against the Jazz GHB controlled‑release family. Jazz's own specification admits it is prior art, stating: "Liang et al. (published U.S. patent application US 2006/0210630 A1) disclose administration of GHB using an immediate release component and a delayed release component" — and then distinguishes it only on the ground that "the delayed release component … function[s] in a pH dependent manner." In the related prosecution, the Office asserted Liang discloses the IR+delayed‑release structure, the 4.5–9 g dose, the mean GHB plasma concentrations (Table 3, FIG. 7) and the dissolution profiles (FIGS. 1–6, Example 7).

Claims it potentially anticipates under § 102(b): Any claim of the '956 patent whose scope is "a controlled‑release GHB dosage form comprising an immediate‑release component and a controlled‑/delayed‑release component, optionally dosed once‑nightly at 4.5–9 g." Because the '956 claims appear to add a non‑pH‑dependent, time‑dependent functional coating (ethylcellulose + pore former), Liang likely does not disclose every limitation of the coating‑specific claims — so for those it is more properly a § 103 reference. For any broad structural/generic claims to IR+CR GHB dosage forms, Liang is squarely § 102(b) anticipatory. (I could not verify the verbatim claim set, so this mapping is scope‑conditioned.)

3. Other references on the '956 front page ("References Cited")

The following U.S. patent documents were listed under (56) References Cited (reconstructed from the patent PDF as surfaced in CourtListener/patentimages; the list is complete as to the items shown but I could not re‑pull the entire page in one view, so treat the tail entries as provisional):

U.S. Patent Application Publications cited: 2006/0210630 A1 (Liang et al.) — the key reference — and 2006/0069040 A1 (Mamelak) (Mamelak appears in the family citation record).

Foreign patent documents expressly discussed in the '956 specification: WO 2006/053186 A2 (Frucht), published ~May 2006 — open‑label study of sodium oxybate in hyperkinetic movement disorders. (Additional WO/JP/CN documents — e.g., WO 1994/028880, WO 2000/038672, WO 2005/099671, WO 2006/029155, WO 2006/080029, WO 2007/053698, WO 2007/103200, WO 2008/086804, WO 2009/056550, WO 2010/055260, WO 2010/055691, WO 2011/119839 — appear in the broader family record; I could not confirm each one is individually listed on the '956 front page, so treat those as provisional.)

Non‑patent literature cited (verified excerpt):

• "HIB‑IMUNE," Physicians' Desk Reference (41st ed.), (1987), 1095–1096
• "HibVAX," Physicians' Desk Reference (41st ed.), (1987), 870
• "Malic Acid," The Handbook of Pharmaceutical Excipients, 2nd Ed., (1994), pp. 285–286, 633
• "Phospholine Iodide," Physicians' Desk Reference (50th ed.), (1996), 2784
• (Also referenced in the specification text: Moldofsky et al., J. Musculoskel. Pain 1:49 (1993) and Psychosom. Med. 37:341 (1975); Scharf et al., J. Rheumatol. 25:1986–1990 (1998); Mamelak et al., Biol. Psych. 12:273–288 (1977); Broughton et al., Can. J. Neurol. Sci. 6:1–6 (1979) and 7:23–30 (1980).)

4. § 102 anticipation mapping (most relevant references)

Bottom line: The only reference close enough to be a genuine § 102 anticipation candidate for the core dosage‑form claims is Liang et al., US 2006/0210630 A1 (and, for very generic controlled‑release GHB claims, Conte et al., US 5,594,030). The remaining cited documents are, in the main, § 103 obviousness references (e.g., Klosa for the salts, Scharf/Cacciaglia/Gessa for GHB pharmacology, Schrier/Teagarden/Flanner/Koehler for controlled‑release tablet technology) rather than single‑reference anticipations, because no one reference discloses the full combination of (i) high GHB drug load, (ii) a non‑pH‑dependent functional coating, and (iii) the specific in‑vitro release / Cmax:Cmin pharmacokinetic profile described in the '956 disclosure.

5. Confidence and limitations (stated per your instructions)

• High confidence: Patent identity, bibliographic data, continuity chain, the identity and date of Liang US 2006/0210630 A1, the Conte US 5,594,030 and Klosa US 4,393,236 citations, the WO 2006/053186 (Frucht) citation, and the fact that the specification admits Liang as prior art.
• Moderate/Provisional confidence: The precise ordering/completeness of the § (56) front‑page U.S. list (some tail entries and the unbracketed "Seibert et al." patent number were not fully verified), the exact publication date of WO 2006/053186, and whether every WO/foreign document in the family record is separately listed on the '956 front page.
• Cannot verify: The verbatim text of the 27 claims — the supplied patent text is truncated before the claims. Consequently, the "which claim(s)" mapping in Section 4 is conditioned on claim scope inferred from the specification, abstract, and this family's prosecution/litigation record, not on a line‑by‑line reading of the issued claims. To make the § 102 analysis claim‑exact, retrieve the claim set from USPTO PatentCenter (Application 17/012,823) or the granted‑patent PDF (US10959956.pdf) and I can re‑run the element‑by‑element comparison.

If you want, I can next produce a claim‑chart for the two strongest references (Liang '630 and Conte '030) as soon as the issued claim text is available.

I'll ground this analysis in the actual prior-art references cited in the patent and in the litigated invalidity record, so let me search for the key pieces.

Let me get the exact claim set of the '956 patent and the specific prior-art references cited on its face.

Let me pull the actual granted claim set of the '956 patent and confirm the priority-art references on its face.

Obviousness Analysis — U.S. Patent No. 10,959,956 under 35 U.S.C. § 103

Analyst/date: US patent analyst — April 26, 2026
Patent: US 10,959,956 B2, Controlled Release Dosage Forms for High Dose, Water Soluble and Hygroscopic Drug Substances, Allphin et al., Jazz Pharmaceuticals, Inc. Priority 2010‑03‑24; granted 2021‑03‑30; anticipated expiration 2031‑03‑24.
Cross‑reference: builds on the prior PTAB section (no AIA proceedings; no estoppel; validity untested at the PTAB).

0. Threshold caveats (read before using this in a filing)

1. I am testing the claims as I can reconstruct them from the record — not from a verbatim grant copy. The authoritative patent text supplied covers the specification only; it does not reproduce the granted claims. The operative claim language I use below is taken from the '956 family as it appears in the Jazz v. Avadel record (D. Del. 1:21‑cv‑01138 / 1:21‑cv‑00691) and the ex parte complaint analysis. Flagged contradiction (carried forward from the prior PTAB section): Avadel's SMF identified asserted claims "1‑20 and 23‑35," while Jazz's counterstatement cited "claims 1‑8 and 10‑11." I cannot resolve that discrepancy and do not rely on a specific asserted-claim set here.
2. Everything labeled "contention" from the litigation record is a party position, not an adjudicated holding. Avadel's invalidity contentions and Jazz's replies are adversarial papers.
3. Per the operating rules, I interpret identifiers literally. Where a search result conflicts with my training data, I follow the search result.

1. What the independent claims appear to require

From the record, the '956 patent is a method‑of‑treatment patent in the same family as the '488/'885 "Sustained Release Patents," directed to treating cataplexy or excessive daytime sleepiness (EDS) associated with narcolepsy by delivering a GHB formulation. Representative independent‑claim language (from the '956/'488 family as quoted in the D. Del. record):

• Treating cataplexy or EDS associated with narcolepsy in a patient in need thereof by delivering a formulation comprising immediate‑release (IR) and solid sustained‑release (SR) portions, each comprising GHB or a pharmaceutically acceptable salt;
• the SR portion comprises about 500 mg to 12 g of GHB/salt and comprises a functional coating deposited over a core that contains the GHB/salt;
• the functional coating comprises one or more methacrylic acid–methyl methacrylate (MAMM) co‑polymers that are about 20% to about 50% by weight of the functional coating (dependent claim narrowing to about 30%–45%);
• plus in‑vitro dissolution limitations: e.g., SR portion releases >40% of its GHB by about 4–6 h and ≤10% by about 1 h, and 60%–90% by about 6 h; and the formulation releases ≥30% by 1 h and >90% by 6, 7, or 8 h, when tested in USP Apparatus 2 in deionized water at 37 °C and 50 rpm.
  (Claim text via CourtListener / Jazz v. Avadel record; ex parte complaint analysis)

Two structural features drive the whole analysis: (i) the IR + SR "single‑unit" architecture, and (ii) the MAMM‑containing functional coating at 20–50 wt%, with the recited dissolution window. Note the internal oddity, which is legally useful to a challenger: the '956 specification criticizes pH‑dependent (enteric) delivery as inconsistent, yet the claims recite MAMM co‑polymers — the very Eudragit L/S chemistry that is a pH‑dependent enteric polymer. That mismatch is a foothold (see § 8).

2. Level of ordinary skill (PHOSITA)

A POSITA here would be a formulation scientist with an advanced degree (or bachelor's + several years) in pharmaceutics/pharmaceutical sciences, experienced in oral controlled‑release dosage‑form design, diffusion‑ and enteric‑film coating, USP dissolution testing, and GHB/oxybate pharmacokinetics. This is the PHOSITA I apply throughout.

3. The prior‑art universe actually of record

The patent's own reference apparatus and the litigation record supply a compact, high‑quality set:

4. Combination A (primary): Liang 2006 + Conte

This is the strongest § 103 case, and it is essentially the case the Office already made against the sibling claims.

What each reference lacks alone. Liang 2006 supplies the IR + delayed/controlled‑release architecture, the GHB drug, the narcolepsy/once‑nightly objective, and MAMM (Eudragit L/S) coatings — but its delayed component is framed as pH‑sensitive enteric particles rather than a film‑coated monolithic tablet with a defined dissolution window. Conte supplies a GHB tablet with a cellulosic (ethylcellulose) matrix + optional acrylic/methacrylic film coat and a measured, near‑constant 8‑h release profile that numerically overlaps the claimed window.

Element mapping (representative independent method claim):

Motivation to combine (KSR factors):

• Same field, same problem, same drug. Both are oral GHB dosage forms aimed at the identical clinical problem — GHB's ~45‑min half‑life and high dose forcing twice‑nightly dosing (Borgen). Liang states the goal explicitly: "a twice‑nightly dosage regimen can be reduced to a single dose with the compositions of the present invention."
• Complementary, non‑overlapping teachings. Liang teaches what (IR + delayed, MAMM enteric coat, once‑nightly) but leaves film‑coated‑tablet engineering open; Conte teaches the tablet core/coat platform and a conforming release profile. POSITA would be motivated to use Conte's robust tablet platform to implement Liang's IR+delayed concept.
• Predictable arts. Diffusion/enteric film‑coating weight gain as the rate‑control lever is textbook (and is the '956 specification's own teaching: release rate adjusted by coating weight, pore‑former amount and molecular weight, base‑polymer grade). Combine with a reasonable expectation that adjusting coat weight/polymer shifts the profile.
• "Obvious to try" / finite solutions. KSR permits obviousness where a finite number of identified, predictable solutions exist; Eudragit L/S grades and EC‑matrix coatings were a small, well‑characterized menu.

Anticipation overlay. Avadel's contentions go further and assert Liang 2006 anticipates the sibling‑claim functional‑coating and dissolution limitations ("Liang 2006 discloses the claimed functional coating"; the claim profile "was known in the art"). That is a party contention; but if credited, the independent claim is also § 102‑dead over Liang alone, and the method claims collapse to the § 103 case a fortiori. (Jazz v. Avadel record)

5. Combination B (secondary): Allphin US 2012/0076865 + Conte, and the Office's own prior rejection

This matters even though Allphin is same‑family (and thus normally not § 102/103 art against '956 if '956's claims enjoy the shared 2010‑03‑24 priority). The reason it matters is procedural, surfaced in the litigation record: the Office rejected claims of a sibling method case as obvious over Allphin, Liang and Conte — "Claims 1‑23 are rejected under 35 U.S.C. 103 as obvious over Allphin et al. ('Allphin', US 20120076865 A1…)" (Jazz v. Avadel claim‑construction appendix, D. Del. 1:21‑cv‑00691 Dkt. 315‑1). Independently, a third‑party prosecution history in the family lists the same triad: "U.S. Pat. No. 5,594,030 to Conte; U.S. Publication 2006/0210630 to Liang; and U.S. Publication 2012/0076865 to Allphin."

Takeaway: the examiner‑facing obviousness combination for this family is Conte + Liang (and Allphin). Caveat: because Allphin is the applicant's own earlier publication from the same priority chain, a challenger must not treat it as § 102/§ 103 art against '956 unless the priority date fails (see §7). Use Allphin only as a roadmap of how the Office framed the combination, and as support for the motivation narrative.

6. Why the numeric limitations do not save the claims (routine optimization)

• 20–50 wt% MAMM. Overlaps Liang's disclosed enteric‑coat weight gains (10–70%, ~30–50% preferred) and Conte's acrylic/methacrylic coating option. Selecting a sub‑range within a disclosed range, absent a showing of criticality, is prima facie obvious (e.g., In re Aller; In re Boesch). Notably, the '956 specification itself recites the 20–50 wt% pore‑former range for the coating — i.e., the patent's own disclosure brackets the claim — undercutting any "critical range" argument.
• 40% by 4–6 h / ≥30% by 1 h / >90% by 8 h. Largely met by Conte's own Table 3 data (≈35% @1 h; 77% @4 h; 88% @6 h; 92% @8 h). A claim that reads on the closest prior art's measured profile is obvious on the profile element.
• USP Apparatus 2, deionized water, 37 °C, 50 rpm. Standard, art‑recognized test conditions; no inventive weight. (The patentee's own original 2011 claims contained no MAMM, no USP‑2, and no deionized‑water recitations — a point Avadel stresses to argue these limits were back‑fitted rather than invented. (BlueMatrix/Jefferies case summary))

7. Threshold § 103 issue the challenger must litigate: the effective filing date

The claims' MAMM / USP‑2 / DI‑water limitations appear to have been introduced in July 2018 (the '488‑family prosecution), whereas the family priority is 2010‑03‑24. This creates a fork that changes the entire § 103 landscape:

• If the claims get the 2010‑03‑24 date (i.e., the 2011 application provides written‑description support), the art that qualifies is pre‑2010/pre‑2011 art (Liang 2006, Conte, Klosa, Frucht) — Combination A applies, and Allphin is not available as art.
• If the MAMM/USP‑2 limitations lack written‑description support in the 2011 disclosure, the effective filing date is 2018 and a far larger § 102/§ 103 arsenal opens, including post‑2010 oxybate‑CR publications.

The patent's own specification cuts both ways: it lists "methacrylic acid‑methyl methacrylate copolymers" among materials usable as a pore former and states pore formers are used "at about 20% to about 50% by weight of the coating" — i.e., the shared 2010 disclosure arguably supports a coating containing MAMM at 20–50 wt%. That same passage, however, is exactly why the limitation is obvious: the MAMM‑at‑20–50% feature is the patent's generic pore‑former teaching, not a discovery. Practically: run the § 103 case on the 2010 priority date (Combination A); plead the priority‑date challenge in the alternative to unlock later art.

8. Anticipated patentee rebuttals and how they fare

Jazz has already articulated its defenses in prosecution/litigation; a challenger should pre‑empt them:

1. "The art teaches away." Jazz argued the Office erred because "the cited art teaches neither the presently claimed structural limitations, nor the presently claimed release profile." Teaching‑away requires the art to criticize, discredit or discourage the solution — Liang and Conte do the opposite (they pursue once‑nightly CR GHB). Mere disclosure of alternatives (Jazz notes Liang's DR2→FS30D switch decreased AUC) is not teaching away. (Jazz claim‑construction appendix)
2. "Unexpected results / superior bioavailability, ileum‑jejunum targeting." The Allphin declaration in prosecution argued the claimed profile "provides superior bioavailability as compared to the formulations in the cited art" and targets jejunum/ileum. This is the patentee's best objective‑indicia card. To rebut it, a challenger must show commensurate scope — the claimed windows (Conte already reads on them) and a nexus between the alleged unexpected result and the claim limits. A generic "flatter PK" claim that is already met by Conte undermines unexpectedness.
3. "The '956 spec disparages pH‑dependent delivery, so the MAMM claims are non‑obvious." Self‑defeating: the claims recite MAMM (enteric) polymers, so the patent cannot simultaneously disclaim them and rely on the disclaimer for patentability.
4. Double‑patenting / derivation‑type defenses (Avadel alleges the family claims were back‑derived after seeing Avadel's disclosure). These are ODP/inequitable‑conduct‑flavored theories, not § 103, but they corroborate that the MAMM/USP‑2 limits were not the original inventive contribution.

9. What would strengthen (or is missing from) this case

• Verbatim granted‑claim text of '956. I reconstructed claim scope from the record; a filing must use the certified copy. The asserted‑claim discrepancy ("1‑20 and 23‑35" vs. "1‑8 and 10‑11") remains unresolved.
• The full "References Cited" face of '956. The supplied page shows only prior‑art keywords and inline citations; the complete front‑page art list should be pulled to add any secondary references (e.g., other GHB/CR or MAMM‑coating patents).
• Conte full text / EP 0 635 265 B1. I have Conte's claims and Table 3 numbers via the record; the complete specification (coating weight ranges, PK) should be obtained to lock the element mapping.
• Priority‑date determination. Obtain the 13/071,369 disclosure and the '956 file wrapper to fix the effective date and thereby which art qualifies.

10. Bottom line for a § 103 challenge

• Primary ground: Claims are obvious over Liang 2006 (US 2006/0210630 A1) in view of Conte (US 5,594,030 / EP 0 635 265 B1). Liang supplies the IR+delayed GHB architecture, the once‑nightly narcolepsy objective, and the MAMM (Eudragit L/S) functional coating at the claimed weight range; Conte supplies the ethylcellulose‑matrix GHB tablet core with an optional acrylic/methacrylic coating and a measured 8‑h profile that numerically reads on the claimed dissolution window. Motivation: same drug, same clinical problem (GHB ~45‑min half‑life), complementary teachings, predictable film‑coating art, finite predictable options.
• Alternative/additional ground: Liang 2006 alone (anticipation or obviousness of the coating/profile limits) per Avadel's contentions, and Conte + Liang + Allphin US 2012/0076865 mirroring the Office's own family rejection.
• Doctrinal hooks: routine optimization of a disclosed range (In re Aller/In re Boesch), KSR "obvious to try," and the specification's own 20–50 wt% pore‑former teaching.
• Biggest risks to the challenge: (a) the effective filing date — if 2010 holds, later art is excluded; (b) the patentee's unexpected‑bioavailability/objective‑indicia story, which requires a commensurate‑scope/nexus attack; (c) reliance on party contentions rather than adjudicated findings. None of these is fatal, and — as the prior PTAB section established — no claim of '956 has ever been canceled, so there is no estoppel and no adverse FWD to overcome.