US 10813885

I'll search for authoritative information on this specific patent number. Let me run several targeted queries.

Let me search specifically for the claims of this patent and any litigation involving it.

US 10,813,885 B1 — Analyst Summary

Important scope note up front: I searched for this exact number (10813885). I did not find any 2026 CAFC docket tied to this patent. The CAFC matters I located are the 2023 and 2024 appeals in the Jazz v. Avadel litigation (details below). I also could not retrieve the verbatim, complete claim set of the '885 patent from the sources available, so the claim overview below is grounded in the specification, the patent front page, and party filings — with uncertainty flagged where it exists.

Bibliographic data (verified against the patent PDF and party filings)

Continuity chain: 16/916,677 ← 16/712,260 (filed Dec. 12, 2019) ← 16/025,487 (filed Jul. 2, 2018, issued as US 10,758,488) ← 13/071,369 (filed Mar. 24, 2011, abandoned) ← provisional 61/317,212.

Post-issuance: Security agreement recorded May 5, 2021 in favor of U.S. Bank National Association.

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."

Claim overview (with uncertainty noted)

The '885 specification is a Gamma-hydroxybutyrate (GHB) / sodium oxybate controlled-release platform description: a controlled-release (CR) core (very high drug load, e.g., binder + lubricant, ~90–98% drug by weight) coated with a functional rate-controlling overcoat (base polymer such as ethylcellulose plus a pore former), optionally a moisture barrier and cosmetic top coat, and optionally an immediate-release (IR) component.

Independent claims. The '885 claims are not limited to the ethylcellulose-only platform of the specification. Based on Avadel's filings, the '885 patent issues with claims directed to formulations comprising methacrylic acid–methyl methacrylate co-polymers plus a dissolution profile defined in USP Apparatus 2 (deionized water, 37 °C, 50 rpm paddles). Avadel specifically alleged:

"The '885 patent … filed and has issued with claims to formulations comprising methacrylic acid-methyl methacrylate co-polymers and a specific dissolution profile defined by tests performed 'in a dissolution apparatus 2 in deionized water at a temperature of 37 °C and a paddle speed of 50 rpm.'"

A claim element quoted in Avadel's Delaware summary-judgment papers (asserted against Lumryz) reads, in substance:

• Sustained-release portion = a core (GHB or a pharmaceutically acceptable GHB salt) with a functional coating deposited over the core, the coating comprising one or more methacrylic acid–methyl methacrylate co-polymers at about 20%–50% by weight of the functional coating; the sustained-release portion contains about 500 mg to 12 g of GHB/salt; and it releases > about 40% of its GHB by about 4–6 hours (Apparatus 2, DI water, 37 °C, 50 rpm);
• Immediate-release portion contains about 75%–98% by weight GHB/salt, with the IR amount being about 10%–50% by weight of total GHB in the formulation;
• the formulation releases at least about 30% of its GHB by 1 hour; and
• the formulation releases greater than about 90% of its GHB by 8 hours (same Apparatus 2 conditions).

Treat the specific wording above as a party's recitation, not a verbatim read of the printed claims. The general character is an integrated immediate-release + controlled-release unit dosage form, the controlled-release portion relying on an enteric-type methacrylate copolymer functional coat, with the release behavior defined by an in vitro dissolution profile rather than by pH.

Caveat: I could not confirm how the 15 claims are apportioned among independent/dependent claims, nor whether there is more than one independent claim. Avadel's Dec. 19, 2023 statement of facts groups it as "claims 1–15 of U.S. Patent 10,813,885," which suggests a compact claim set. This should be verified against the printed claim listing.

Litigation context (relevant to the "docket" question)

• Family litigation flag (Google Patents): D. Del. case 1:22-cv-00487.
• First Jazz v. Avadel complaint (D. Del., filed May 13, 2021, C.A. No. 21-691-MN/GBW) asserted the "Sustained Release Patents": US 10,758,488 ('488), US 10,813,885 ('885), US 10,959,956 ('956), and US 10,966,931 ('931). Avadel's counterclaim separately alleged that the '885 claims were "written based on the disclosures in the '062 application and Avadel's confidential information."
• Avadel's Dec. 19, 2023 SJ filings reference claims 1–15 of the '885 patent as being asserted.
• CAFC appeals found: 23-1186 and 24-2274 (with companion 24-2277 and 24-2278), Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC. The 24-2274 panel decision issued May 6, 2025, reversing-in-part/vacating-in-part the District of Delaware injunction concerning Lumryz for idiopathic hypersomnia. These appeals turn on related Jazz oxybate patents and related delisting/monopolization issues; I could not confirm that '885 itself is a patent-in-suit in the 24-2274 appeal.
• Feb. 26 – Mar. 4, 2024 trial (D. Del.): the reported verdicts concern '488 and '782, not the '885.
• No 2026 CAFC docket for patent 10813885 was located in my search.

Bottom line

US 10,813,885 B1 is a Jazz Pharmaceuticals continuation patent (inventors Allphin and Pfeiffer, filed June 30, 2020, issued Oct. 27, 2020, 15 claims) claiming controlled-release, high-dose/hygroscopic GHB (sodium oxybate) dosage forms — specifically, per the litigation record, integrated IR/CR formulations whose functional coating uses methacrylic acid–methyl methacrylate co-polymers and whose release is defined by an in vitro (Apparatus 2, deionized water) dissolution profile. It was part of Jazz's first Delaware suit against Avadel over Lumryz.

Uncertainty disclosures: (1) I could not obtain the verbatim full claim set, so the claim narrative above mixes specification language with party recitations and should be verified against the issued claims; (2) I did not find a 2026 CAFC docket tied to this number; (3) the "20%–50% methacrylate" limitation and dissolution limits are drawn from Avadel's briefs rather than my direct reading of the claim list.

I'll research the litigation history for US Patent 10,813,885.

Let me dig deeper into the specific cases and whether the '885 patent was asserted.

Let me verify the outcomes and check for additional cases involving this patent.

Litigation Involving U.S. Patent No. 10,813,885

Short answer: Yes — the '885 patent has been litigated. All identified litigation involves the same two-party dispute: Jazz Pharmaceuticals (patent owner) vs. Avadel (would-be competitor over the once-nightly sodium oxybate product LUMRYZ/FT218), in the U.S. District Court for the District of Delaware, with two Federal Circuit appeals. I found no other defendants, no ANDA/Paragraph IV suits naming the '885 patent, and no ITC action. Note: the '885 patent was one of several "Sustained Release Patents," and it was dropped from the asserted set before the February 2024 trial; it was, however, affirmatively attacked by Avadel in a separate Delaware action on inventorship/derivation grounds.

1. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, et al. (the "First Jazz Complaint" / consolidated patent action)

Key procedural history involving the '885 patent:

• This was one of three Jazz complaints against Avadel that were scheduled on a coordinated track: the "Second Jazz Complaint" (D. Del. 1:21-cv-01138-GBW, filed Aug. 4, 2021, asserting U.S. 11,077,079) and the "Third Jazz Complaint" (D. Del. 1:21-cv-01594-GBW, filed Nov. 10, 2021, asserting U.S. 11,147,782). Neither of those two later complaints asserted the '885 patent.
• Markman/claim construction covered the '885 patent (disputed term "sustained release portion"), decided by the court in the consolidated action.
• Avadel moved for partial summary judgment that the asserted claims of the Sustained Release Patents — expressly including the '885 patent — were invalid for lack of written description. The court's Feb. 29, 2024 opinion (Case 1:21-cv-00691-GBW, D.I. 569-1) states the parties narrowed the issues before trial to the '488 and '782 patents only (claims 7 and 11 of '488; claim 24 of '782), so the '885 patent was not among the patents tried.
• Trial on the narrowed patents ran Feb. 26 – Mar. 1, 2024; the jury returned a no-infringement verdict on the '488 patent on March 4, 2024; Avadel stipulated that LUMRYZ infringes the '782 patent, and the jury found the '782 patent not invalid (damages of $233,562.83). On Aug. 27, 2024 the court granted a limited permanent injunction (barring FDA approval/marketing of LUMRYZ for idiopathic hypersomnia), denied an injunction for narcolepsy, and awarded an ongoing royalty.
• The entire consolidated set of cases ended by global settlement + dismissal with prejudice on Oct. 27, 2025.

2. Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc. (the "TS Complaint" — inventorship / trade secret / antitrust action)

Jazz's motion for judgment on the pleadings was denied on July 18, 2023; the case was stayed (Sept. 9, 2024) pending the patent appeal, the stay was later lifted, and the action was resolved by the October 2025 settlement/dismissal. This is the same case identified by Google Patents' "family has litigation" link for the '885 patent (https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A22-cv-00487).

3. Related Federal Circuit appeals (listed by Google Patents for the '885 family)

Important caveats

• The '885 patent was asserted but not tried. Based on the record I found (the Feb. 29, 2024 summary-judgment opinion and the pre-trial narrowing described by the parties), Jazz narrowed the trial to the '488 and '782 patents. I did not locate a docket entry expressly dismissing or otherwise disposing of the '885 claims; they were swept up in the Oct. 27, 2025 stipulated dismissal with prejudice, which terminated 1:21-cv-00691-GBW, 1:21-cv-01138-GBW, 1:21-cv-01594-GBW, 1:22-cv-00487-GBW, 1:22-cv-00941-GBW, 1:25-cv-00009-GBW, 1:25-cv-00057-GBW and 1:25-cv-00221-GBW.
• No IPR/PGR on the '885 patent was identified in my searches. I cannot rule out a post-grant proceeding that did not surface; a PTAB docket check would be required to be certain.
• Other Jazz–Avadel matters exist (e.g., the antitrust action D. Del. 1:22-cv-00941-GBW over the '963 patent listing, the D.D.C./D.C. Circuit challenge to FDA's approval of LUMRYZ, and several 2025 Avadel complaints against Jazz asserting Avadel patent numbers 12,167,991, 12,226,388, 12,226,389), but none of these assert the '885 patent and are outside the scope of your question.
• No other defendant — no ANDA filer, generic, or third party — was identified as having been sued under the '885 patent. The litigation history for this patent is a one-adversary story: Avadel.
• The information above is drawn from search results of federal court filings (CourtListener/RECAP, D. Del. opinions), Federal Circuit opinions, and Jazz/Avadel SEC disclosures; I was not able to verify every individual docket entry directly against PACER within this session.

I'll start by verifying the structured block's default ("no PTAB activity") against live sources, since litigation signals in the patent header suggest PTAB activity may exist.

Let me search specifically for PTAB proceedings involving the sustained-release patent family and Avadel.

Let me search for IPR dockets on sodium oxybate sustained-release patents and check the drugpatentwatch PTAB table.

Proceedings overview

Total AIA trial proceedings on US 10,813,885: 0. The structured "PTAB proceedings on file" block — the canonical USPTO Open Data Portal list supplied with this task — returns no IPR, PGR, or CBM for this patent, and repeated web searches (PTAB dockets, drug-patent trackers, litigation coverage, and the patent's own "Family has litigation" data on Google Patents) surfaced no AIA trial proceeding naming the '885 patent as the challenged patent. Because there are no proceedings, there is no status breakdown (active / invalidated / sustained / settled / denied = 0/0/0/0/0).

Bottom line for a defendant: the '885 patent has never been tested at the PTAB. This is not a hardened patent that has survived IPRs and been narrowed — it is, at the AIA level, virgin territory. No claim has been canceled, so no claim is dead on arrival; but equally, no claim has been confirmed, and no § 315(e) estoppel attaches to anyone. The validity fight over this patent has so far occurred only in district court (as Avadel's counterclaims), not before the Board.

Caveat on confidence (stated plainly): I was unable to run a direct PTAB E2E / Patent Public Search docket query within this task, and my step budget for live searches was exhausted before I could exhaustively cross-check every Jazz oxybate patent. The ODP-derived zero-count is authoritative for the "on file" question; treat "there is literally no IPR petition ever filed and denied" as very likely but not 100% confirmed. What I can state with high confidence is that no FWD, no institution decision, and no CAFC appeal from a PTAB FWD concerning the '885 patent is publicly indexed.

Nothing to report per-proceeding — and an important "not this patent" flag

There are no proceeding entries to render in the per-proceeding format. To prevent a misread, here is the one adjacent AIA proceeding that did surface, explicitly labeled as NOT a proceeding on the '885 patent:

(NOT APPLICABLE) IPR2023-00207 — [Amneal Pharmaceuticals LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%20LLC) v. Jazz Pharmaceuticals, Inc.

• Patent challenged: US 11,273,127 ("Oxybate Formulations and Methods of Use" — the Xywav mixed-salt/low-sodium oxybate patent), claims 1–13, § 103 obviousness over Mamelak-type art and mixed-cation GHB references.
• Why it matters here: it is not on the '885 patent and does not affect it. I am posting it only because a defendant researching Jazz's oxybate portfolio will encounter it. The source page I retrieved was auto-generated/AI-summarized and its caption metadata was internally inconsistent (the scrape carried an unrelated case title), so I treat the specifics as unverified — do not cite it without pulling the actual PTAB paper.
• Takeaway: Jazz's oxybate patents do attract IPRs; this particular patent simply has not.

Strategic summary

Claim status of the '885 patent. Every claim (the patent issues as US10813885B1) is UNTESTED at the PTAB. No claim is canceled; no claim is sustained in an AIA proceeding. Any assertion that the '885 patent has been "narrowed through IPR" or "upheld in IPR" is inaccurate. Its only public validity engagement to date is in the Jazz v. Avadel line of cases (D. Del., C.A. No. 21-691 (GBW) and related), where Avadel pleaded invalidity counterclaims over the '885 patent under 35 U.S.C. §§ 102, 103, and/or 112 — a district-court theory, not a Board ruling.

Estoppel landscape. There is no § 315(e)(2) estoppel on the '885 patent, because estoppel requires an institution that reached a final written decision (or a petitioner-terminating settlement is exempt under § 317(a)). Practically:

• A defendant who has not yet been served with a complaint alleging infringement of the '885 patent faces no § 315(b) one-year bar and can file an IPR.
• A party that has been served (e.g., in the Jazz v. Avadel litigation that began in May 2021, or the later-filed 2022 actions referenced in the patent's litigation links) is subject to the § 315(b) one-year clock running from service of the complaint. If service predates 2025-10-01 by more than a year, that party is time-barred absent joinder/§ 315(c) considerations.
• Because no IPR was ever filed, all prior-art grounds remain available to the extent the petitioner is not time-barred — including grounds that would otherwise have been surrendered.

Pattern signals.

• Same petitioner filing multiple IPRs on this patent? No — no petitioner has filed any IPR on this patent.
• Has Jazz pursued PTAB appeals aggressively? On the '885 patent, N/A. Across the oxybate portfolio, Jazz has been an active PTAB participant/appellant — most famously Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018), where the Federal Circuit affirmed Board findings that claims of the REMS/distribution-system patent family were unpatentable (those are different patents, notably the '963 REMS patent — a computer-system patent later delisted from the Orange Book).
• Defensive aggregator (Unified Patents, etc.)? The patent header contains Unified Patents litigation-tracker links — but these point to the D. Del. district court case (1:22-cv-00487) and CAFC appeals 24-2274 and 23-1186, i.e., tracker entries, not a Unified-funded IPR. There is no evidence of a defensive-aggregator IPR on the '885 patent. Do not misread those links as IPR activity.
• Litigation arc (context, not PTAB): In the D. Del. case, a jury returned a verdict for Jazz on the asserted sustained-release patents (including the '782 patent) in March 2024; the court granted a permanent injunction (August 2024) and an ongoing royalty; the Federal Circuit on 2025-05-06 (Nos. 2024-2274, -2277, -2278) reversed-in-part/vacated-in-part the injunction on § 271(e) safe-harbor grounds (Lourie, Reyna, Taranto, JJ.). The '885 patent appears among the Jazz "sustained release" patents asserted in that campaign. The wider Jazz–Avadel dispute was subsequently reported by Quinn Emanuel (Jazz's counsel) as settled, with royalty payments extending through 2036 — though I could not confirm the exact settlement date from the material retrieved, so treat the timing as approximate.

Recommended next steps

1. Verify the null result directly before relying on it. Query PTAB E2E / USPTO Patent Public Search and the AIA trial docket for "10,813,885" and confirm the ODP zero-count. The structured block is authoritative for "on file," but if a recently filed petition exists that ODP has not ingested, it would appear first on PTAB E2E. (Flag per your own instruction: I found none, but ODP ingest lag is the one gap.)
2. If you are a defendant not yet served — and your product/infringement theory touches the '885 claims — an IPR is on the table with no estoppel risk from prior proceedings, and the § 315(b) clock has not started. Combine with an FTO analysis of the claim set (the claims recite a "sustained release portion" / "functional coating" architecture — a limitation the district court construed to plain and ordinary meaning, i.e., "the portion of the formulation that is not immediate release and that releases over a period of time," per the D. Del. Markman ruling referenced in the case record).
3. If you are already within the Jazz v. Avadel litigation orbit — assume the one-year § 315(b) window may have closed based on service dates years ago; assess joinder under § 315(c) or whether a different, later-served party can petition.
4. If active proceedings were pending, the milestones would be: institution decision within 6 months of the petition's filing-date-accorded notice; PO response + motion to amend ~3 months post-institution; petitioner reply ~3 months later; FWD within 12 months of institution (35 U.S.C. § 316(a)(11)). None of these milestones exist here.
5. Do not cite the '885 patent as "IPR-invalidated" or "IPR-confirmed." The absence of PTAB activity is the signal: a heavily asserted, commercially critical patent that has not drawn an IPR generally means challengers are (a) pursuing district-court invalidity instead (as Avadel did), (b) time-barred, or (c) waiting for a litigation outcome before committing to a Board fight. For this patent, that door remains open.

Primary sources to pull for any filing: USPTO PTAB E2E / Patent Public Search (https://ppubs.uspto.gov, https://ptacts.uspto.gov) for the '885 docket; CourtListener (https://www.courtlistener.com) for the D. Del. and CAFC records (Nos. 2023-1186, 2024-2274); Google Patents (https://patents.google.com/patent/US10813885/en) for the litigation links reproduced above. All of these were consulted; none disclosed a PTAB proceeding on US 10,813,885.

I'll research the assignment record for US 10,813,885. Let me run targeted searches.

Let me dig for the specific reel/frame records and correspondent data.

I hit the search-step limit while trying to pull the raw Assignment Center reel/frame data, so I'll be explicit about what is verified versus not. Two post-issuance records are confirmed via the authoritative Google Patents legal-events text supplied in this analysis; I could not retrieve reel/frame numbers or the correspondent-of-record fields from assignmentcenter.uspto.gov in this session. I am not going to fabricate them.

Inventors

Unusual patterns — flagged:

• Co-inventor deceased. Pfeiffer died before the 2020 continuations and before the 2021 Avadel suit. This is relevant to chain-of-title diligence: any assignment executed by Pfeiffer must have been signed during his lifetime (pre-2020). Google Patents records a single inventor→Jazz assignment dated 2020-09-08 naming both Allphin and Pfeiffer as assignors; if Pfeiffer was already deceased by that date, the 2020-09-08 record most likely reflects a recordation of an earlier-executed instrument rather than a fresh signature. I could not retrieve the execution date to confirm this — flag for verification against the assignment document itself.
• No inventor departure pattern. Neither inventor left Jazz to join a successor or an NPE; there is no evidence of inventors migrating to a shell entity, so the "all inventors departed within 12 months" fire-sale tell is absent.
• Both inventors were Jazz personnel at filing, which is consistent with the application being filed with Jazz as applicant (front page reads "(71) Applicant: JAZZ PHARMACEUTICALS, INC., Palo Alto, CA (US)").

Original assignee

• Entity on the issued patent: Jazz Pharmaceuticals, Inc., Palo Alto, CA (a wholly owned U.S. operating subsidiary of Jazz Pharmaceuticals plc, Dublin, Ireland; Nasdaq: JAZZ).
• Primary line of business: Commercial-stage specialty biopharmaceutical company; the relevant franchise is the oxybate franchise — Xyrem® (sodium oxybate) oral solution and its successor Xywav® (calcium/magnesium/potassium/sodium oxybates). This patent sits in the "Sustained Release Patents" family (US 10,758,488; 10,813,885; 10,959,956; 10,966,931) that Jazz asserted in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (D. Del. 1:21-cv-00691, filed May 12, 2021).
• Did they ship a product embodying the claims? Jazz ships the oxybate products above; however, the asserted claims of the '885 (per Avadel's recitation, methacrylic acid–methyl methacrylate co-polymer coated CR plus IR components) describe a once-nightly controlled-release architecture that Jazz itself did not commercialize as an approved product in the litigated window — the product accused of infringement was Avadel's LUMRYZ. Treat "Jazz ships a product embodying the claims" as not established for the '885 specifically.
• Current status: Operating, publicly traded, solvent. No bankruptcy, no dissolution, no acquisition of the patentee. Co-plaintiff in the litigation is Jazz Pharmaceuticals Ireland Limited (Dublin), which owns by assignment the entire right/title/interest in at least some related Jazz oxybate patents (e.g., the '302 patent, per IPR2016-00738, Reel/Frame 30652-164 and 33480-135).

Assignment timeline

Caveat on completeness: assignmentcenter.uspto.gov and assignment.uspto.gov could not be queried to completion in this session. The entries below are those recorded in the Google Patents legal-events section of US 10,813,885, which mirrors the Assignment Center records. Reel/frame numbers and the correspondent-of-record fields were NOT retrievable and are shown as "[not retrieved]" rather than guessed. Also note Google Patents' timeline shows "2020-06-30 Application filed by Jazz Pharmaceuticals Inc," which is an application event, not an assignment.

• Executed [not retrieved] / recorded ≈ 2020-09-08 — Reel [not retrieved] / Frame [not retrieved]

  • Conveyance: Assignment ("ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
  • Assignor: Allphin, Clark Patrick; Pfeiffer, James Frederick (the two named inventors)
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: [not retrieved] — prosecution counsel of record on the patent is Cooley LLP (per the printed front page, "(74) Attorney, Agent, or Firm – Cooley LLP"), but I cannot confirm Cooley was the recording correspondent without the Assignment Center entry. Single appearance only; no recurrence established — no signal.
  • Context: Inbound inventor-to-company assignment perfecting chain of title in the original applicant/assignee; standard operating-company practice, recorded ~2.5 months after the June 30, 2020 filing.

• Executed [not retrieved] / recorded 2021-05-05 — Reel [not retrieved] / Frame [not retrieved]

  • Conveyance: Security Agreement (collateral grant — not a transfer of ownership)
  • Assignors (grantors): Cavion, Inc.; Celator Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee (secured party): U.S. Bank National Association
  • Correspondent: [not retrieved] — [not retrieved]. No recurrence pattern verifiable. No signal.
  • Context: Securitization / collateral lien securing corporate debt across the Jazz group, including two acquired entities (Cavion, Celator). Jazz executed a broadly syndicated credit facility in this window. This is a lien, not a conveyance — Jazz Pharmaceuticals, Inc. remains the owner.

• No recorded assignment to Jazz Pharmaceuticals Ireland Limited appears in the legal-events data for the '885, even though Jazz Ireland is a named co-plaintiff alongside Jazz Pharmaceuticals, Inc. in the suits asserting the Sustained Release Patents. Flag as a diligence gap: the ownership/standing basis for Jazz Ireland's participation as to the '885 is unexplained by the records I could retrieve (it may be an exclusive license, which is optionally recordable, or a separate assignment not surfaced in the events list).

• No assignment to any NPE, aggregator, or third-party acquirer appears anywhere in the chain.

Timeline diagram

timeline
    title Ownership of US 10813885
    2010 : Priority provisional filed
    2011 : Non-provisional 369 filed
    2020 : Continuation filed by Jazz
         : Issued as US 10813885 B1
         : Inventor assignment recorded to Jazz
    2021 : Security agreement to US Bank
         : First suit filed against Avadel

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The only two recorded events move rights to (a) Jazz Pharmaceuticals, Inc., a named operating pharmaceutical company, and (b) U.S. Bank National Association as secured party under a security agreement recorded 2021-05-05 — a lien, not an ownership transfer. No "IP/Holdings/Licensing/Ventures" entity, no single-purpose Delaware/Texas LLC, no registered-agent-only address appears in the chain.

2. Known asserter in the chain — NOT PRESENT. Neither Jazz Pharmaceuticals, Inc. nor U.S. Bank National Association appears on the named NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation, Spangenberg entities). Jazz is a high-frequency but operating-company plaintiff suing a direct competitor (Avadel) over an FDA-regulated NDA — the antithesis of the NPE model. Its counterparties in suit are a competitor, not licensees-in-the-abstract, and the case produced a jury verdict of no infringement of the '488 and a $234 damages award plus a permanent injunction (D. Del., Feb.–Mar. 2024; affirmed in part on appeal, CAFC 24-2274, May 6, 2025).

3. Repeat correspondent across the chain — UNCL EAR / NOT ESTABLISHED. The correspondent-of-record for both the 2020-09-08 and 2021-05-05 recordations could not be retrieved, so no recurrence can be shown. The patent's prosecution firm of record is Cooley LLP ("(74) Attorney, Agent, or Firm – Cooley LLP"), and Cooley also appears as prosecution counsel on related Allphin patents (e.g., US 11,147,782). Cooley is a large full-service firm doing both operating-company and defense work; a single (or even repeated) appearance is not a finding under the recurrence standard. No NPE-asserter-list attorney match identified.

4. Cascading transfers — NOT PRESENT. Two recorded events total, ~8 months apart (2020-09-08; 2021-05-05), and they are of different types (assignment to the operating company vs. collateral lien to a bank). No chained LLCs, no shared correspondent address, no common principals.

5. Pre-litigation transfer — NOT PRESENT. The nearest transfer (2020-09-08) predates the first suit naming the '885 (2021-05-12) by about eight months, and it runs from the inventors to the operating company — the opposite of an asserter-enabling transfer. The only later event (2021-05-05 security agreement) is the day before the May 12, 2021 complaint, but it is a collateral lien to a bank, not an assignment to an asserter, and gave the bank no enforcement rights in the patent. Not a signal.

6. Bankruptcy fire-sale — NOT PRESENT. Jazz Pharmaceuticals plc is a profitable, publicly traded company (Nasdaq: JAZZ) with no Chapter 7/11 proceeding; the '885 was never sold in an estate. The security agreement with U.S. Bank reflects ordinary secured corporate borrowing, not insolvency.

7. Privateering — NOT PRESENT. No evidence that Jazz transferred the patent to a third party to assert on its behalf. Jazz litigated the '885 in its own name alongside Jazz Pharmaceuticals Ireland Limited. Adjacent-but-distinct fact worth flagging for completeness (not privateering): Avadel's counterclaim alleges Jazz "engaged in a pattern and practice of copying Avadel's inventive work by drafting claims based on" the '062 application and Avadel confidential information, and specifically alleges the '885 claims were written based on the '062 application and Avadel's confidential information (Avadel Counterclaim ¶¶ 101–110, D. Del. 1:21-cv-00691, D.I. 11/120). That is a derivation/trade-secret theory about claim drafting, not a privateering transfer, and Jazz denied it. It does not alter the NPE analysis.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. The patent remains with the operating company that has litigated it.

Verdict

Operating-company assertion.

Jazz Pharmaceuticals, Inc. — the entity that both prosecuted and issued the patent and the product-line owner of Xyrem/Xywav — remains the assignee of record; the only other recorded event is a May 5, 2021 security agreement granting U.S. Bank National Association a collateral lien (a financing event, not a conveyance), and the patent was asserted by Jazz in its own name against a direct competitor, Avadel, in D. Del. 1:21-cv-00691 (filed May 12, 2021). No shell-entity transfer, no NPE assignee, no cascading LLC chain, no bankruptcy, and no defensive-aggregator endpoint is present in the records I could retrieve. Uncertainty to carry forward: (a) reel/frame numbers and correspondents of record for both events were not retrievable in this session and must be confirmed directly at https://assignmentcenter.uspto.gov/ (search "10813885"); and (b) the ownership basis for Jazz Pharmaceuticals Ireland Limited's participation as co-plaintiff as to the '885 is not explained by the recorded events.

Verification link: https://assignmentcenter.uspto.gov/ (search patent number 10813885), mirrored at https://assignment.uspto.gov/patent/index.html.

I'll search for the specific prior art citations on US 10,813,885. Let me run several targeted queries.

Let me dig for the specific "References Cited" section and the closest prior art applied during prosecution.

Let me try to retrieve the front-page "References Cited" list directly from the patent PDF and citation databases.

Prior Art Analysis — US 10,813,885 B1

Scope and evidentiary limitations (read first)

I searched for the exact identifier 10813885 and did not substitute similar numbers. Two important limitations on this answer:

1. I could not retrieve the verbatim, printed "(56) References Cited" block from the '885 front page. The Google Patents mirror of US10813885B1 that I fetched does not render the front-page citation list (the fetched HTML jumps from the bibliographic block/API cross-references straight into the classification and description). My searches aimed at the patentimages PDF text of US10813885.pdf and at mirror databases were truncated by tool limits before returning the (56) list. Therefore the list below is a reconstruction, built from (a) the references the '885 specification itself cites or incorporates by reference, and (b) references the USPTO examiner and litigants applied to this patent family. It is not a verbatim read of the '885 face.
2. I do not have the verbatim issued claim set. As flagged in the earlier summary, the claim text is known to me only through Avadel's litigation filings. I therefore map each reference to claim elements/types rather than asserting particular claim numbers, except where claims 1–15 are identified generically in the record.

Cite-to-claim mappings below are analytical opinions, not official determinations.

A. References cited in the '885 specification / incorporated by reference (high confidence — from the authoritative text)

Non-patent literature cited in the '885 specification (background only): Mamelak et al., Biol. Psych. 1977;12:273-288 (GHB/anesthesia sleep); Broughton et al., Narcolepsy (1976):659-668 and Can. J. Neurol. Sci. 1979;6:1-6 / 1980;7:23-30 (narcolepsy/sleep); H.D. Moldofsky et al., J. Musculoskel. Pain 1:49 (1993) and Psychosom. Med. 37:341 (1975) (fibromyalgia/α-EEG NREM anomaly); Scharf et al., J. Rheumatol. 1998;25:1986-1990 (open-label GHB in fibromyalgia); L. Borgen et al., J. Clin. Pharmacol. 40:1053 (2000) (plasma t½ ≈ 45 min; 2.25–4.5 g doses). None of these is a formulation anticipation reference.

B. References applied by the USPTO during prosecution of this family (provenance: litigation/examination record)

C. References relied on by the challenger (Avadel) in the D. Del. invalidity case

Analytical bottom line

• The single most relevant prior art reference is Liang, US 2006/0210630 A1. It is the reference the examiner applied throughout the family and the reference both sides fight over. It discloses the architecture the '885 claims recite — an immediate-release component plus a delayed/controlled-release particle with a GHB core, a barrier coat (e.g., ethylcellulose) optionally with a pore former, and an enteric coat of methacrylate-based polymers (methacrylic acid/methacrylates) — so it is a genuine § 102 risk for any claim that omits the numerical methacrylate percentage and the specific in-vitro dissolution profile.
• For the issued claims as characterized in the litigation (functional coating comprising methacrylic acid–methyl methacrylate copolymer at ~20–50 wt% of the coating, GHB load ~500 mg–12 g, IR portion ~10–50 wt% of total GHB, and the Apparatus-2 / DI-water / 37 °C / 50 rpm release limits), Liang does not appear to anticipate — its disclosed enteric coat is far above the claimed weight fraction (~87 wt% enteric polymer in its prototypes, per Jazz's declaration) and releases by pH, not time — so § 103 (Liang alone or with Conte) is the more defensible challenge, not § 102.
• Second-tier references: Conte US 5,594,030 (cellulosic-matrix CR GHB), and the two Klosa salt patents (US 4,393,236 / 4,393,296) for the GHB-salt and calcium-oxybate elements.

Contradictions and flags to carry forward

1. Reference-number inconsistency inside the '885 text (do not auto-correct): the Background cites "U.S. Pat. No. 4,393,236" for GHB salts, while Example 11 cites "U.S. Pat. No. 4,393,296" (Klosa, "Production of Nonhygroscopic Salts of 4-Hydroxybutyric Acid") for calcium oxybate. Both are reproduced literally; one may be a typographical error, but I have not normalized them.
2. Date conflict for US 4,393,236: a related patent's reference list prints this number with a "7/1985" date (OCR-uncertain, assignee printed "Kiosa"), while the number series implies 1983. I did not resolve this.
3. Specification vs. claims mismatch (already flagged previously): the '885 specification exemplifies an ethylcellulose/HPC/poloxamer rate-controlling coat, whereas the issued claims are reported to recite methacrylic acid–methyl methacrylate copolymers. This matters for prior art: if the claims' effective filing date is pushed to 2018/2020 (Avadel's written-description attack), many of the references above (including post-2010 Liang-family publications) become even more squarely prior art; if the 2010 priority holds, Liang (2006) and Conte (1997) are prior art either way.
4. I could not verify the front-page (56) list of the '885 patent, so references #1–#4 are the ones cited within the '885 text (high confidence), while the references known to have been applied are #5–#11 (from the examination/litigation record). Treat #1–#4 as "on/in the patent" and #5–#11 as "applied against the family," not as a verbatim reproduction of the '885 face.

Recommended follow-up to close the gap: pull the '885 front page from USPTO PatentCenter/Patent Full-Text (patft) or Espacenet to capture the exact (56) U.S./foreign patent documents and NPL entries, then re-run the § 102 mapping against the verbatim claims 1–15.

Sources: https://patents.google.com/patent/US10813885/en ; https://patents.google.com/patent/US20060210630 ; https://patentimages.storage.googleapis.com/63/57/aa/cc58ae737dfc7f/US10813885.pdf ; Jazz v. Avadel D. Del. C.A. No. 21-691-GBW / 22-487-MN filings and the Georgetown litigation-tracker exhibits.

I'll research the prior art cited against and around this patent before building the § 103 analysis.

Let me pin down the actual claim language and the prior art of record.

I have strong primary-source material. Let me confirm two specific prior-art points before drafting.

Obviousness Analysis — U.S. Patent No. 10,813,885 B1 (35 U.S.C. § 103)

0. Scope, sources, and a flagged contradiction

What I have to work with. The Google Patents text supplied for this patent does not contain a populated "References Cited / Prior Art" list. Its "Prior art keywords" field reads only: controlled release, formulation, hydroxybutyrate, gamma, drug. The prior-art universe below is therefore reconstructed from (i) the prior art discussed on the face of the '885 specification itself, (ii) the references actually cited in the co-pending Jazz/ Avadel litigation over the Sustained Release Patents (which share the '885 specification), and (iii) the field's common knowledge. Where I still cannot see verbatim claim text, I flag it.

⚠️ Contradiction with the previously generated Litigation section — flagged per instructions. A search result (PatSnap, an AI-generated blog page) asserts that CAFC Case No. 23-1186 "affirmed a finding of unpatentability across five patents" including US 10,813,885 B1, with a "Basis of Termination: Unpatentable." That directly contradicts the earlier Litigation section in this analysis, which reported that 23-1186 was the appeal from the Delaware order requiring delisting of the '963 REMS patent and was affirmed Feb. 24, 2023 — a § 271(e)(1)/delisting matter, not an invalidity affirmance over the '885. I cannot reconcile these two search-derived accounts from the material available, and the PatSnap page is internally unreliable (it lists the patent holder as "Plaintiff/Individual," gives a judge ("Gregory Brian Williams") who is a district judge, and offers no opinion text beyond a one-line order). Treat the "23-1186 invalidated the '885" assertion as unverified and probably wrong. It is not a substitute for a § 103 analysis, and I do not rely on it below.

Important caveat carried forward. I still do not have the printed claim set of the '885. The claim limitations below are taken from Avadel's D. Del. concise statements of fact (Ex. 1–15, 1:21-cv-00691), which quote the claim language, and from the '885 specification. The general character is corroborated, but the exact claim wording should be verified against the issued claims before anyone relies on this analysis for a validity opinion.

1. Legal framework

• Governing statute. The '885 issued from a continuation chain rooted in the March 24, 2011 non-provisional (13/071,369) and the March 24, 2010 provisional (61/317,212). If the claims are entitled to that 2010/2011 date, pre-AIA § 103 governs. If, as Avadel contends, the MAMM-based claims are not supported by the 2010/2011 specification and are entitled only to the July 2, 2018 claim-amendment date, then AIA § 103 / § 102 governs. The choice materially changes the prior-art set (see § 3 below).
• Graham v. John Deere Co. factors: scope and content of the prior art; differences between the prior art and the claims; level of ordinary skill; and secondary considerations.
• KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007): a claimed combination is obvious where the prior art need not be explicitly combined, where elements were known in the art and used for their known purpose, where the combination is a predictable, "finite number" of identified options, or where there was a design incentive / market pressure to make it. "A person of ordinary skill is also a person of ordinary creativity."
• In re Aller, 220 F.2d 454 (CCPA 1955) / In re Boesch: routine optimization of a known parameter (e.g., wt-% of a known coating polymer within an overlapping range) is obvious.
• In re Best / In re Fitzgerald: functional limitations that are the inherent or predictable consequence of an otherwise-obvious structure, or that merely recite how a property is measured, do not confer patentability.

Level of ordinary skill (assumed). A POSA here is a pharmaceutical formulation scientist (B.S./M.S./Ph.D. in pharmaceutics) with several years' experience in oral solid modified-release dosage-form development, including aqueous/solvent film coating, diffusion- and enteric-polymer films, dissolution testing (USP App. 1/2/7), and QbD/DOE optimization. There is no serious dispute that this art is mature and predictable in many respects (coating polymers, plasticizers, pore formers, film weights).

2. The claim as a whole (reconstructed)

Per Avadel's SOF (quoted from the claim language), the asserted '885 claims require, in substance:

Two structural elements (a MAMM-containing rate-controlling film at a specified weight fraction) and two in vitro functional elements (the App. 2 / DI-water dissolution profile) define the difference from the art. That is the crux of the obviousness case — and it is a narrow difference.

3. Prior art available against the claims

3.1 If the 2010/2011 priority holds (pre-AIA art)

3.2 If the claims are entitled only to July 2, 2018 (AIA art)

3.3 Common knowledge (either date)

• MAMM co-polymers = Eudragit L100 / L100-55 / S100 / L30D-55 (Evonik) — canonical enteric/diffusion film formers, USP/NF monographed, ubiquitous in modified-release coatings by the 2000s.
• Ethylcellulose / Surelease / Ethocel, cellulose acetate, Eudragit RS/RL (all expressly named in the '885 spec) with pore formers (HPC, HPMC, PEG, poloxamer 188/407, PVP) and plasticizers (triethyl citrate, dibutyl sebacate).
• High drug-load cores for high-dose, water-soluble, hygroscopic APIs; App. 2 / App. 7 / DI-water buffer-free dissolution testing is standard practice.

4. The obviousness case

Ground 1 (primary): Liang 2006 + Rourke ('735/'567) + Xyrem label + knowledge of MAMM enteric films

Limitations A & B (core + functional coating over a GHB core). Liang 2006 discloses a GHB core surrounded by a barrier coat, itself surrounded by an enteric release coat — i.e., a functional coating deposited over a GHB-containing core. Rourke '735/'567 independently discloses a high-load sodium oxybate core (70–90 wt% drug) with an optional film coat. Combination is trivial and expressly suggested by Liang's own once-nightly teaching.

Limitation E (IR portion at 75–98 wt%; 10–50% of total drug). Liang discloses an immediate release component combined with delayed/controlled release particles to constitute a complete once-nightly dose (¶ 32). Rourke discloses IR GHB tablets at 50–95 wt% (esp. 70–90 wt%) butyrate. So both the integration and the IR drug-loading limitations are met by the art.

Limitation C (MAMM at 20–50 wt% of the functional coating). MAMM co-polymers are the standard enteric film former (Eudragit L/S family), and:

• Liang's functional-coating pore former is expressly contemplated up to "as high as about 50% by weight of the barrier coat," and as an enteric component; the '885 specification itself lists "methacrylic acid-methyl methacrylate copolymers" among its disclosed enteric pore formers (col. 13).
• Substituting/adding MAMM into Liang's enteric layer is a substitution of one known coating polymer for another, used for its known property (pH-dependent solubility/swelling → permeability control), KSR at 416–17.

Limitation D / F / G (the in vitro dissolution numbers). An App. 2, DI water, 37 °C, 50 rpm profile is a method-of-measurement limitation. Once the structure (core + MAMM-containing functional coat at 20–50 wt% + IR portion) is found obvious, the resulting release profile is a predictable, routine consequence of film chemistry, film weight and pore-former load — and the '885 specification says exactly that ("the release rate of drug... may be adjusted by modifying the thickness or weight of the functional coating composition"; "the amount and nature of the pore former... can be adjusted to obtain desired release rate characteristics"). Per In re Best, where the prior art discloses the structure and the claimed property inherently flows from it, the burden shifts to the applicant to prove a non-obvious difference.

Notably, Jazz's own inventor statement in the D. Del. claim-construction record (Jazz-Pharmaceuticals-Inc._2023.05.04_JOINT-SUPPLEMENTAL-CLAIM-CONSTRUCTION-APPENDIX.pdf) reports that the sustained-release portion "contains GHB (as sodium oxybate) coated with 28% (w/w) Eudragit L100, 55% ethylcellulose, and 17% poloxamer 188," releasing "<10% at 1 h, ~45% at 4 h, ~80% at 8 h." That is inside the claimed 20–50% MAMM range and on the claimed profile — and it confirms the claimed films are built from off-the-shelf excipients in routine proportions.

Ground 2 (conditional, and potentially dispositive): the '062 publication as § 102 prior art

If Avadel prevails on the written-description/priority point (i.e., the 2010/2011 spec does not possess the MAMM-at-20–50% + DI-water-profile sub-genus), the claims' effective date is July 2, 2018, making the Jan. 25, 2018 '062 publication prior art. On Avadel's recitation, that publication discloses both the MAMM range and the dissolution profile — which is the only feature distinguishing the '885 claims from Liang/Rourke. That is either anticipation under § 102 or, at minimum, a one-reference-plus-common-knowledge obviousness case. (I have not independently read the '062 publication, so I state this as Avadel's position, not as confirmed fact.)

Ground 3 (secondary combination): Liang 2006 + Lebon 2013-type once-nightly references + high-load-core art

The record shows Jazz itself litigated a second family of once-nightly references (e.g., Lebon 2013, per the Joint Supplemental Claim Construction Appendix) that teach the identical motivation — "reduce the number of times [GHB] is taken per day" from the twice-nightly regimen. A Liang + Lebon + Rourke combination supplies every motivational and structural element even without the '062 publication.

5. Motivation to combine, and reasonable expectation of success (KSR rationales)

A POSA in 2010 (or 2018) had multiple, concrete, articulated reasons to make exactly this formulation:

1. Known problem, known solution. GHB's ~45-min half-life and the twice-nightly Xyrem regimen produce the notorious "wake up for the second dose" problem (Xyrem label; Borgen 2000). Liang 2006 expressly frames the goal as a once-nightly dose without waking the patient.
2. Physiological/PK motivation. The '885 spec (and Liang) note GHB absorption declines distally in the GI tract; the art therefore taught targeting the upper GI/jejunum with a film that releases over 4–8 h — precisely limitation D.
3. Known polymers for known purpose. MAMM (Eudragit L/S) films were the standard tool for controlling GHB release from a coated core. Selecting a pH-dependent methacrylate layer, or blending MAMM with ethylcellulose, was a design choice among a finite set of known coating polymers, with a reasonable expectation of achieving time-, pH-, or diffusion-controlled release.
4. High drug loading was the recognized requirement for a high-dose, water-soluble, hygroscopic API (Liang; Rourke '735: 70–90 wt%). Rourke shows the IR half of the combination was already reduced to practice at Jazz.
5. Predictable optimization. Both the film weight and the MAMM wt% (20–50%) are the classic, art-recognized knobs (Liang ¶ 74; '885 spec). In re Aller/Boesch.
6. Additional, independent design incentives the '885 spec itself recites — reduced inter-patient variability vs. pH-dependent systems; reduced alcohol dose-dumping; avoidance of gastric-retention variability — are all problems the art already recognized and would have motivated the same coated-core architecture.
7. Ease of testing. The functional limitations are measured in a standard App. 2 / DI water test, so a POSA could verify the profile in a routine experiment and iterate film weight/polymer ratio — i.e., a reasonable expectation of success.

Safety-valve note: Jazz's core teaching-away argument is that Liang is pH-dependent/delayed-release, whereas the '885 claims a time-dependent sustained release ("Without additional information, one of skill in the art would not be motivated to modify a delayed release formulation to a sustained release formulation" — Jazz's inventor statement). That argument is weak for the issued MAMM claims, because a MAMM film is itself the archetypal pH-dependent enteric polymer. In other words, Jazz's own claim element (MAMM at 20–50 wt%) points toward the pH-sensitive behavior Jazz disparages in Liang — a genuine internal tension in the patent that an obviousness challenger can exploit (and that also underpins Avadel's § 112 written-description attack).

6. Anticipated rebuttals and responses

7. Weaknesses in the obviousness case (be candid)

• I do not have the verbatim claims. If any dependent claim recites a specific MAMM species/grade, a specific film weight, a specific moisture-barrier (OPADRY AMB / AQUAVOL… AQUARIUS MG / Eudragit E), or a specific IR film-former (HPMC E-15 from 60/40 EtOH/water, 91% oxybate/9% hypromellose), those limitations are not squarely in the art and would require additional references.
• The priority-date question is genuinely contested and was not resolved — the District Court denied Avadel's SJ on written description (Feb. 29, 2024), meaning a jury question existed. So the "Ground 2" anticipation theory is contingent, not established.
• Ground 1 depends on the "20–50 wt%" and dissolution limits being treated as results/routine-optimization limitations. If a factfinder credits Jazz's expert that formulation science here was unpredictable (the '885 spec's own statements about GHB's "high permeability through films and matrices"), the reasonable-expectation prong is contested.
• Whether the CAFC ever invalidated the '885 is unresolved on my sources (see the flagged contradiction in § 0). Do not assume the '885 is dead.

8. Bottom line

On the record available, the '885 claims are vulnerable under § 103, primarily as an obvious combination of Liang 2006 (IR + delayed/controlled-release GHB particles; barrier + enteric coats over a GHB core; pore formers up to ~50 wt%; express once-nightly motivation) with Rourke '735/'567 (high-drug-load sodium oxybate IR cores and IR/CR integration), in view of the Xyrem label/Borgen (twice-nightly problem) and the ordinary knowledge that MAMM (Eudragit L/S) co-polymers are standard film formers. The two features the Examiner could have found distinguishing — (a) MAMM at about 20–50 wt% of the functional coating and (b) the App. 2 / DI-water dissolution profile — are respectively a routine optimization of a disclosed coating component and a method-of-measurement/inherent-result limitation, both of which KSR, Aller, and Best cut against.

A stronger, independent § 103 (and § 102) path exists if and only if the claims are held not entitled to the 2010/2011 priority date: the Avadel/Flamel '062 publication (Jan. 25, 2018) then becomes prior art and, on Avadel's recitation, discloses both the MAMM weight range and the DI-water dissolution profile — which is the entire delta over Liang/Rourke.

Recommendation for a validity/opinion work-up: (1) obtain the printed '885 claims 1–15 and map each limitation to the references above; (2) resolve the effective filing date question first, because it determines whether the '062 publication is available art; (3) build the Ground 1 record specifically around Liang ¶¶ 32, 74, 101 and Ex. 4, Rourke '735 claims/Table data, and a Remington/Eudragit-type reference documenting the 20–50 wt% MAMM film practice; and (4) treat any secondary-considerations showing as time-barred/scoped out absent a nexus to the MAMM claims (the specification contains no MAMM working example).