US 8263650

I'll search for information on this specific patent and any associated litigation.

Let me do one more targeted check for any 2026 appellate activity.

US Patent 8,263,650 — Analyst Summary

Sourcing note: The following draws on the full patent text you supplied (from Google Patents, https://patents.google.com/patent/[US8263650](/patent/US8263650)/en), plus search results from Google Patents/Justia, drugpatentwatch.com, CourtListener, and Jazz Pharmaceuticals' own announcement. I searched for a CAFC 2026 docket specifically naming US 8,263,650 and found none — see the litigation/caution section below.

Bibliographic Data

Prosecution chain (from the specification): This is a continuation of 13/182,324 (filed Jul. 13, 2011) → continuation of 12/913,644 (Oct. 27, 2010) → continuation of 11/777,877 (issued as US 7,851,506) → divisional of 10/841,709 (issued as US 7,262,219) → divisional of 10/194,021 (issued as US 6,780,889) → divisional of 09/470,570 (issued as US 6,472,431) → priority to 60/113,745 (Dec. 23, 1998).

Abstract (verbatim)

"Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient."

Independent Claims — Plain-Language Overview

The patent has 18 claims total, with three independent claims (1, 11, 15). (Claim text below is as reproduced by drugpatentwatch.com for patent 8,263,650, consistent with the patent's disclosure.)

Claim 1 — Composition
A pharmaceutical composition that is an aqueous solution of about 500 mg/ml sodium gamma-hydroxybutyrate (sodium oxybate), with a pH of about 7.3 to about 8.5. The composition must be chemically stable and resistant to microbial growth, and critically must be free of preservatives. (The "free of preservatives" limitation is the key point distinguishing it from the parent '431-family composition claims.)

• Dependent claims 2–4 recite specific pH values (about 7.5, 8.0, 8.5).
• Dependent claims 5–10 recite inclusion of a pH-adjusting/buffering agent (acid; inorganic or organic; a listed group including malic, citric, acetic, boric, lactic, hydrochloric, phosphoric, sulfuric, nitric; with malic acid specifically claimed in claim 10).

Claim 11 — Method of treatment
A method of treating cataplexy or daytime sleepiness in a patient having narcolepsy, comprising diluting the composition of claim 1 and administering the diluted composition to the patient. (The "dilute-then-administer" step was added in this continuation, reportedly after Jazz learned of a competitor's non-infringement argument that relied on a dilution step — see litigation note below.)

• Claims 12–14 add: oral administration; administration as two consecutive single doses daily; first dose prior to bedtime and second dose about 2.5 to 4.0 hours after the first.

Claim 15 — Set / kit
A set (kit) comprising the composition of claim 1 in one or more container means.

• Claims 16–18 add: container means selected from drinking cup, dosing cup, syringe, pipette, vial, ampule, test tube, flask, bottle, pouch syringe; and (17–18) a third container means retaining a first container (the composition) and a second container (a diluent) plus one or more delivery vehicles.

Litigation & Post-Grant Activity (with caution)

• District court: The '650 patent was asserted in numerous Hatch-Waxman / Paragraph IV actions consolidated in the District of New Jersey (e.g., Jazz Pharms. v. Roxane, 2:12-cv-06761; Jazz v. Amneal, 2:13-cv-00391; and others), and listed in Orange Book Paragraph IV notices (e.g., Par Pharmaceutical, Nov. 2013). It also appeared in the In re Xyrem (Sodium Oxybate) Antitrust Litigation, N.D. Cal., 3:20-md-02966, and in related antitrust suits by health plans/insurers.
• Reported expiration: December 22, 2019; pediatric exclusivity extended the listed date to June 22, 2020.
• CAFC 2026 docket: I could not identify any Federal Circuit case docketed in 2026 that names US 8,263,650 as an asserted patent. The 2025–2026 Federal Circuit sodium-oxybate activity I found (e.g., Avadel CNS Pharms. v. Jazz Pharms., Nos. 24-2274/24-2277, decided May 6, 2025) concerns other patents (e.g., US 11,147,782; US 10,966,931; REMS-related and Flamel modified-release patents) — not the '650 patent.

Uncertainty / caveats:

1. I did not retrieve an authoritative grant/claim page directly from USPTO Patent Center or the official Federal Circuit docket for this ID; claim wording is taken from a third-party patent database and is consistent with the specification you provided. Verify against the official USPTO text before relying on exact claim language.
2. Because the '650 patent expired in 2019, it is unlikely to be the subject of a live 2026 appeal; the absence of a 2026 CAFC docket naming it is consistent with that, but I cannot affirmatively confirm a negative from the searches performed.
3. I did not locate a PTAB inter partes review instituted specifically against the '650 patent; PTAB activity I found centered on sibling patents in the same '431 family (e.g., the '107 patent, IPR2015-00547). Do not assume no IPR exists.

If you need the official claim set or a certified docket, the primary sources to pull are the USPTO Patent Center record for application 13/446,940 and the Federal Circuit/PACER docket search filtered to "8,263,650."

I'll research litigation involving US Patent 8,263,650. Let me start with searches on litigation databases.

Let me search litigation databases specifically for cases citing this patent.

Let me pin down specific ANDA case details and outcomes.

I've reached my research step limit, so here's what I found from the sources I was able to reach. Important caveat up front: the litigation databases I could access (Google Patents' litigation links, DrugPatentWatch, paragraphfour.com, CourtListener, and Jazz's own SEC filings) do not always display party names or outcomes for every docket, and I was cut off before I could confirm every docket's parties/termination. I flag unconfirmed entries explicitly rather than guessing.

Litigation Involving U.S. Patent No. 8,263,650

Context: The '650 patent ("Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy," Cook et al., issued Sept. 11, 2012) is part of the Xyrem® (sodium oxybate) patent family and was asserted as part of Jazz Pharmaceuticals' Orange Book patent campaign against generic ANDA filers. Assignee of record: Jazz Pharmaceuticals, Inc.

A. Hatch-Waxman / ANDA patent-infringement suits (the '650 patent asserted)

The '650 patent was asserted in Jazz's second wave of Xyrem infringement suits. Jazz's own investor disclosures confirm two of these on the record:

Note on outcomes for the "second filer" suits (§A nos. 2–8): According to a subsequent antitrust class-action complaint, Jazz entered settlement agreements with the second-filer generic applicants that limited early generic volumes and pushed full generic competition to at least Dec. 31, 2025. I could not, within my step budget, retrieve the individual settlement dates/terms for Amneal, Par, Ranbaxy, Watson, Wockhardt, Lupin, or Ascent.

B. Antitrust / class-action litigation in which the '650 patent is part of the at-issue patent portfolio

These are not patent-infringement suits, but the '650 patent is expressly identified in the complaints as one of the Xyrem patents central to the alleged "evergreening"/sham-litigation scheme.

Outcome: The MDL resolved via class settlements; the court granted final approval on October 27, 2025 (N.D. Cal., 3:20-md-02966, Doc. 1066).

C. PTAB / IPR

I did not find a confirmed inter partes review petition specifically challenging U.S. Patent No. 8,263,650. (There was an IPR on a related Xyrem patent, IPR2016-00002, directed at U.S. Pat. No. 8,772,306 — a different number.) I could not complete a full PTAB search, so treat this as "not confirmed" rather than "none exists."

D. Related proceeding worth noting

• Jazz Pharmaceuticals Ireland Ltd. v. Tris Pharma, Inc. (D.N.J.) — reported coverage (Law360) indicates a New Jersey federal judge refused to let Tris escape a suit alleging its proposed Xyrem competitor infringes "a series of patents." I could not confirm within my budget whether the '650 patent is among the patents asserted in that case; it is part of the broader Xyrem patent campaign and may be relevant.

Summary of current status

• The '650 patent expired/anticipated expiration Dec. 22, 2019 (per Google Patents legal status; the patent is now "Expired – Fee Related"). This explains why the infringement suits concluded via settlement and the later activity is antitrust-based.
• All identified patent-infringement cases involving the '650 patent were resolved by settlement (not judgment): the Roxane/Hikma suit settled April 5, 2017; the other ANDA suits settled in connection with the broader Xyrem generic-entry schedule.
• The antitrust MDL (3:20-md-02966) reached final settlement approval Oct. 27, 2025.

Limitations

1. I was unable to confirm party names for D.N.J. 2:17-cv-05487 or D. Del. 1:18-cv-02032 and 1:21-cv-00691.
2. Outcomes for individual second-filer suits are given by inference from settlement documents and the MDL complaint; exact settlement dates/terms are confidential or not displayed in the free sources available to me.
3. Google Patents, DrugPatentWatch, and paragraphfour.com are secondary aggregators; the authoritative dockets (PACER) and the Federal Circuit were not fully retrievable within the step limit. If you need certified docket-level detail, PACER pulls for the specific case numbers above (especially 2:12-cv-06761, 2:17-cv-04439, and 1:18-cv-02032) would be the next step.

Would you like me to prioritize confirming any specific docket (e.g., the 2:17-cv-05487 party or the D. Del. cases) if you can extend the research budget?

I'll start by verifying the structured PTAB data against live sources before drafting.

Let me confirm whether any IPR specifically targeted the '650 patent, and check the CBM activity.

Let me do one final confirmation search on whether the '650 or its formulation-family siblings were ever subject to a CBM or IPR.

Proceedings overview

There are zero AIA trial proceedings on US 8,263,650. The USPTO Open Data Portal structured block returns no IPR, PGR, or CBM against this patent, and my independent web checks corroborate that: the Amneal/Par IPR wave (IPR2015-00545 through -00554 and IPR2015-01903) and the CBM wave (CBM2014-00149/-00150/-00151/-00153/-00175) all targeted the '730-family distribution-system patents (7,668,730, 7,765,106, 7,765,107, 7,895,059, 8,457,988, 8,589,182, 8,731,963) — not the '650 formulation patent. Note the important distinction because it changes the defensive story completely: this is not a "hardened patent that survived IPRs" case, and it is not a "claims canceled" case either. The '650's 18 claims were never tested at the Board; they issued, were asserted in district court Hatch-Waxman litigation, and then expired on 2019-12-22 (pediatric exclusivity to 2020-06-22) — which is why no IPR was ever filed and why none can be now. Bottom line for a defendant today: the '650 is expired, so any effort to assert it is a non-starter on temporal grounds alone.

Proceedings on US 8,263,650

None. No proceeding to enumerate.

I will not manufacture a proceeding list. Per the operating rule to interpret identifiers literally: nothing in the structured data, and nothing in public searching, ties any AIA trial number to patent 8,263,650 as the challenged patent.

Closely related patents — proceedings you may be confusing with this one (same Xyrem portfolio, same owner, different patents — do not attribute these dispositions to the '650):

• IPR2015-00545 — Amneal & Par v. Jazz — U.S. 8,589,182 ('182) — instituted 2015-07-28; FWD 2016-12-22 (unpatentable); Fed. Cir. affirmed.
• IPR2015-00546 — Amneal & Par v. Jazz — U.S. 7,765,106 ('106) — instituted 2015-07-28; FWD 2016-12-22 (unpatentable); Fed. Cir. affirmed.
• IPR2015-00547 — Amneal & Par v. Jazz — U.S. 7,765,107 ('107) — instituted 2015-07-28; FWD 2016-12-22 (unpatentable); Fed. Cir. affirmed.
• IPR2015-00548 — Amneal & Par v. Jazz — U.S. 7,895,059 ('059) — instituted 2015-07-28; FWD 2016-12-22 (unpatentable); Fed. Cir. affirmed.
• IPR2015-00551 — Amneal & Par v. Jazz — U.S. 8,457,988 ('988) — instituted 2015-07-28; FWD 2016-12-22 (unpatentable); Fed. Cir. affirmed.
• IPR2015-00554 — Amneal & Par v. Jazz — U.S. 7,668,730 ('730) — instituted 2015-07-28; FWD 2016-12-22 (unpatentable); Fed. Cir. affirmed.
• IPR2015-01903 — Amneal & Par v. Jazz — U.S. 8,731,963 ('963) — instituted 2016-03-25; FWD 2017-03-22 (unpatentable); Fed. Cir. affirmed.
• CBM2014-00149/-00150/-00151/-00153 — Par, Roxane & Amneal v. Jazz — '059, '988, '730, '182 — institution denied 2015-01-13 (not CBM-eligible).
• CBM2014-00175 — v. Jazz — U.S. 7,765,107 ('107) — related CBM, subject to the same 2015-01-13 denial reasoning.

Consolidated FWD (representative, IPR2015-00551 / -00554, panel Bonilla, Mitchell, Murphy): https://ipwatchdog.com/wp-content/uploads/2018/01/730-final-written-decision.pdf
Institution decision (IPR2015-00551/-00554): https://paragraphfour.com/uploads/cases15/ipr15-0551IRD.pdf
CBM denial (CBM2014-00149/-150/-151/-153): https://ptabtrialblog.com/wp-content/uploads/2015/01/CBM2014-00149-150-151-153-Denying-Institution-of-Cover-Business-Method-Review-20150113.pdf
Appeal disposition: Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 895 F.3d 1347 (Fed. Cir. 2018) (Newman, Lourie, Reyna) — affirmed on public-accessibility of the Advisory Committee Art, claim construction, and obviousness.

The critical legal point from that line of cases — and the reason the '730 family died while the '650 was untouched — is that the Amneal/Par prior art (the "Advisory Committee Art" from the June 2001 FDA advisory committee meeting) was directed to drug distribution / REMS, which maps onto the '730-family claims and not onto a formulation claim reciting "about 500 mg/ml ... pH about 7.3 to about 8.5 ... free of preservatives." There was no IPR-ready printed-publication attack on the '650's formulation claims of the same quality, so generic challengers fought the '650 in district court instead.

Strategic summary

Cancelled vs. sustained vs. untested. No claim of US 8,263,650 was ever canceled at the PTAB — all 18 claims (independents 1, 11, 15 and their dependents) remained as issued and are "untested" before the Board. That is not a sign of strength; it reflects that (a) the '650's formulation claims were not the soft target that the '730-family distribution claims were, and (b) the patent's term ended before a challenger had both incentive and a viable ground. Because the patent expired 2019-12-22, the claim-status question is largely academic — the claims cannot be asserted for prospective infringement, and the § 315(b) one-year window is moot.

Estoppel landscape. There is no § 315(e)(2) estoppel running against anyone on this patent, because no IPR was ever instituted on it. A defendant would face no statutory estoppel traceable to the '650. (Any estoppel from the '730-family IPRs is patent-specific and does not attach to the '650's claims.) In practice, of course, a defendant does not need estoppel protection against an expired patent.

Pattern signals. Amneal and Par were serial, coordinated IPR petitioners against the Xyrem portfolio and won across the board — but they never petitioned against the '650 (or the other '431-family formulation patents such as the '889, '219, '506, '275, '203). Wockhardt Bio AG also filed separate IPRs in the family (per the Duane Morris/Lexology account) and settled before the Federal Circuit. The '650 was instead litigated in district court (D.N.J. consolidated Hatch-Waxman actions — e.g., Jazz v. Roxane, 2:10-cv-06108; Jazz v. Amneal, 2:13-cv-00391) and later became a pricing/antitrust target in In re Xyrem (Sodium Oxybate) Antitrust Litigation and related health-plan suits. The most serious non-PTAB validity/enforceability attack on the '650 was Roxane's inequitable-conduct counterclaim alleging Jazz withheld Canadian Application CA 338 during prosecution — that theory lived in district court, not at the Board. I did not verify how that inequitable-conduct claim was finally resolved, so treat it as unresolved on the record I have.

One open item I could not pin down. A docket-alarm exhibit path references a case captioned "IPR2015-01117 — Inter Partes Review of U.S. Pat. 8,642,012," with Jazz as patent owner. I could not confirm the target patent number or disposition from a primary source, and 8,642,012 is not 8,263,650, so I am not listing it as a proceeding on this patent. Flagging it only so you don't assume the family IPR set was limited to the ten numbers above.

Recommended next steps

1. Say it plainly to the client: no PTAB proceeding exists on US 8,263,650. The absence is meaningful here, but not in the usual "well-asserted patents eventually attract IPRs" way — it is because the patent expired 2019-12-22 (with pediatric exclusivity to 2020-06-22) before a viable formulation-specific IPR ground matured. Verify expiration at the USPTO Patent Center record for application 13/446,940 and the Orange Book listing.
2. If a demand letter or complaint cites the '650 today, the dispositive response is temporal, not invalidity: the patent's term has run, so there can be no prospective-infringement liability. You do not need an IPR, and you cannot file one (a petition against an expired patent is pointless and, for prospective relief, moot).
3. Do not import the '730-family FWDs into a '650 analysis. The Board's § 103 holdings in IPR2015-00545/-546/-547/-548/-551/-554 and IPR2015-01903 turned on the Advisory Committee Art and distribution-system claim limitations; those findings were affirmed in Jazz v. Amneal, 895 F.3d 1347, but they say nothing about the § 102/§ 103 status of the '650's formulation claims. Cite them only for the printed-publication/public-accessibility law they establish.
4. If your real dispute involves a live Jazz Xyrem patent (e.g., the REMS/Flamel patents addressed in Avadel CNS Pharms. v. Jazz Pharms., Nos. 24-2274/24-2277 (Fed. Cir. 2025)), pull that patent's own PTAB record and docket — it is a different patent family with its own estoppel and IPR history.
5. For a verified negative, the authoritative check is the USPTO PTAB E2E / ODP search filtered to patent number 8,263,650 and application 13/446,940; I could not retrieve a certified absence-of-record from the primary source in this session, so confirm there before relying on the negative in a filing.

Caveats on sourcing: the proceeding list above is drawn from third-party aggregations (the antitrust complaint's recitation of the IPR numbers, PTAB exhibit PDFs, Law360/Lexology/IPWatchdog reports, and docket-alarm/CourtListener exhibits), not from a certified docket pull for each case. Claim-level FWD dispositions for the '730-family are stated at the independent-claim level ("all claims unpatentable") as reported; I have not independently re-read each of the six FWDs claim-by-claim. Verify against PTAB E2E before quoting in any brief.

I'll research the assignment record for US 8,263,650 through USPTO Assignment Center data and cross-reference public sources.

Let me search for the specific recorded assignment reel/frame data and the corporate history.

Let me search for the specific reel/frame numbers and correspondent attorney of record.

I hit the tool-call limit before retrieving reel/frame-level detail from the Assignment Center. Below I reconstruct the record from the authoritative patent text you supplied (which embeds the USPTO assignment events surfaced by Google Patents) plus cross-referenced public sources, and I flag plainly where data is missing rather than guess.

Data-availability caveat (read first). The USPTO Assignment Center / Assignment Search record for US 8,263,650 was not retrievable in my searches — I could not pull reel/frame numbers or the correspondent (recording attorney/agent) of record for any link. The Google Patents legal-events block embedded in your authoritative patent text is drawn from the same USPTO assignment database, so assignor/assignee/conveyance/date below are reliably sourced, but reel/frame and correspondent fields are blank/unverified. Treat any reel/frame reference as "not obtained," not as "does not exist." Verify at USPTO Assignment Center and assignment.uspto.gov by application 13/446,940 or patent 8,263,650.

Inventors

All five executed an assignment in favor of Orphan Medical, Inc. (the assignor list on the recorded inventor→company assignment reads: "DANIELSON, DOUGLAS, GODERSTAD, COLETTE, REARDAN, DAYTON, COOK, HARRY, HAMILTON, MARTHA"). Individual titles/roles and exact execution dates are not determinable from the sources retrieved.

Unusual-pattern check: No "mass departure within 12 months" signal found. I found no evidence that the inventors left Orphan Medical shortly after the 1998–99 filing, and I will not infer one. Note the historical fact that Jazz acquired the whole company in 2005 (below), so any eventual inventor separation is a function of a corporate acquisition, not a stand-alone portfolio fire-sale.

Original assignee

Two distinct "originals" apply, and they differ by document:

• Invention / patent family: originated with Orphan Medical, Inc. — a Minnesota-based specialty pharmaceutical company whose lead product was Xyrem® (sodium oxybate). Orphan did ship a commercial product embodying the claims (FDA approved Xyrem for cataplexy-associated narcolepsy in 2002; for excessive daytime sleepiness in 2005). Orphan Medical was an operating company, not a holding vehicle.
• Applicant/assignee of this continuation (App. 13/446,940, filed 2012): Jazz Pharmaceuticals, Inc. (Google Patents lists the "Original Assignee" as Jazz Pharmaceuticals Inc, and the current assignee likewise as Jazz Pharmaceuticals Inc).

Status:

• Orphan Medical was acquired by Jazz Pharmaceuticals in 2005 via Twist Merger Sub, Inc. (Agreement and Plan of Merger dated April 18, 2005; ~$122.6M / $10.75 per share; closed in 2005). It became a wholly owned Jazz subsidiary and no longer operates independently. Orphan was also subject to a 2007 DOJ criminal fine ($5M) + $12.26M restitution and a Corporate Integrity Agreement — a compliance event, not a bankruptcy.
• Jazz Pharmaceuticals, Inc. remains an operating commercial-stage pharma company (now under Jazz Pharmaceuticals plc, Ireland); Xyrem became Jazz's flagship, generating ~$1.6B in 2019 revenue. Jazz has never filed for bankruptcy (it "flirted with bankruptcy" around 2009 per plaintiffs' pleadings, but did not file).

Contradiction to flag: your previously-generated bibliography lists "Original assignee: Orphan Medical, Inc. (later Jazz Pharmaceuticals)," whereas Google Patents lists "Original Assignee: Jazz Pharmaceuticals Inc." Both are defensible — Orphan is the original assignee of the invention/family; Jazz is the original assignee/applicant of this continuation patent. Neither is an error; they describe different documents.

Assignment timeline

All entries below are the recorded reassignment events for US 8,263,650 as surfaced in the patent's legal-events record. Reel/frame: NOT OBTAINED. Correspondent: NOT OBTAINED. Execution dates are likewise not exposed in this channel (only the recording date is), so the dates shown are recording dates unless a public corporate document supplies an execution date.

• Recorded 2012-07-17 — Reel not obtained

  • Conveyance: Assignment (inventor → company)
  • Assignor: Danielson, Douglas; Goderstad, Colette; Reardan, Dayton; Cook, Harry; Hamilton, Martha
  • Assignee: Orphan Medical, Inc.
  • Correspondent: not obtained
  • Context: Original inventor assignment, re-recorded in bulk in 2012 while cleaning the chain of title for the then-newly issued continuation (title-perfection housekeeping).

• Recorded 2012-07-17 — Reel not obtained

  • Conveyance: Assignment (corporate conversion/reincorporation)
  • Assignor: Orphan Medical, Inc., a Minnesota corporation
  • Assignee: Orphan Medical, Inc., a Delaware corporation
  • Correspondent: not obtained
  • Context: Internal reincorporation (MN → DE), not an arm's-length transfer.

• Recorded 2012-07-17 — Reel not obtained

  • Conveyance: Assignment (entity conversion)
  • Assignor: Orphan Medical, Inc. (Delaware)
  • Assignee: Orphan Medical, LLC
  • Correspondent: not obtained
  • Context: Internal reorganization / conversion of the operating subsidiary into an LLC within the Jazz group.

• Recorded 2012-07-17 — Reel not obtained

  • Conveyance: Assignment
  • Assignor: Orphan Medical, LLC
  • Assignee: JPI Commercial, LLC
  • Correspondent: not obtained
  • Context: Internal transfer to Jazz's commercial/patent-holding entity (JPI Commercial, LLC was signing Xyrem license amendments with Solvay as early as 2008).

• Recorded 2012-07-17 — Reel not obtained

  • Conveyance: Assignment
  • Assignor: JPI Commercial, LLC
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not obtained
  • Context: Final internal step consolidating title in the public parent's U.S. operating company (title clean-up three months before the first '650 suit; see signal 5 below).

• Recorded 2012-08-06 — Reel not obtained

  • Conveyance: Security Agreement (grant of security interest)
  • Assignor: EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: Barclays Bank PLC, as Collateral Agent
  • Correspondent: not obtained
  • Context: Securitization — collateral grant under Jazz's June 12, 2012 credit facility (Barclays as agent). Typical operating-company secured financing.

• Recorded 2015-06-19 — Reel not obtained

  • Conveyance: Security Agreement
  • Assignor: Jazz Pharmaceuticals International III Limited; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: Bank of America, N.A., as Collateral Agent
  • Correspondent: not obtained
  • Context: Securitization — collateral grant under the June 18, 2015 credit agreement (BofA as agent), replacing/securing the newer facility.

• Recorded 2015-07-09 — Reel not obtained

  • Conveyance: Release by Secured Party
  • Assignor: Barclays Bank PLC, as Collateral Agent
  • Assignee: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals International Limited; EUSA Pharma (USA), Inc.
  • Correspondent: not obtained
  • Context: Lien release — Barclays discharging its security interest upon refinancing.

• Recorded 2021-05-05 — Reel not obtained

  • Conveyance: Release by Secured Party
  • Assignor: Bank of America, N.A.
  • Assignee: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals International III Limited; Celator Pharmaceuticals, Inc.; Cavion, Inc.; Jazz Pharmaceuticals Ireland Limited
  • Correspondent: not obtained
  • Context: Lien release — BofA discharging its security interest.

• Recorded 2021-05-05 — Reel not obtained

  • Conveyance: Security Agreement
  • Assignor: Cavion, Inc.; Celator Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: U.S. Bank National Association (later succeeded by U.S. Bank Trust Company, National Association)
  • Correspondent: not obtained
  • Context: Securitization — collateral grant under the May 5, 2021 credit agreement; and the last ownership taker.

Bottom line on this section: There are recorded assignments (not a "no records" case), but they are entirely intra-group Jazz-family transfers plus lender security interests. There is no assignment to any third-party or non-Jazz entity anywhere in the chain.

Timeline diagram

timeline
    title Ownership of US 8263650
    1998 : Provisional filed by Orphan Medical
    1999 : Non-provisional filed
    2002 : Xyrem approved
    2005 : Jazz acquires Orphan Medical
    2012 : Continuation filed by Jazz
    2012 : Patent issues
    2012 : Inventor and corporate chain re-recorded to Jazz
    2012 : Security interest to Barclays
    2012 : First suit on 650 patent filed
    2015 : Security agreement with Bank of America
    2019 : Anticipated expiration
    2021 : Security agreement with US Bank

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The 2012-07-17 chained transfers move the patent within the Jazz corporate family (Orphan Medical MN → Orphan Medical DE → Orphan Medical LLC → JPI Commercial LLC → Jazz Pharmaceuticals, Inc.). No assignee carries an "IP / Patents / Licensing / Ventures" suffix; assignees share the Jazz corporate identity, and the terminal holder (Jazz Pharmaceuticals, Inc.) is the operating company that ships Xyrem and that is the entity of record suing ANDA filers. A chain of similarly-named LLCs can look shell-like, but here the evidence (named operating parent, product in commerce, same corporate group) rebuts the inference.

2. Known asserter in the chain — NOT PRESENT. No assignee or prior holder matches the public NPE lists you enumerated (Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, DGC, Spangenberg entities). The chain terminates at Jazz Pharmaceuticals and its secured lenders.

3. Repeat correspondent across the chain — UNCLEAR / NOT OBTAINED. This is the one signal I deliberately cannot resolve: the correspondent of record was not retrievable for any of the eleven events above. Because five separate conveyances were recorded on the identical date (2012-07-17), it is likely a single firm handled the bulk recordation — but that is an inference about a recorder, not a finding, and I have no name to cite. Do not treat the 2012-07-17 batch as evidence of a repeat NPE lawyer; it is equally consistent with routine inside/outside counsel title clean-up by a major pharma.

4. Cascading transfers — PRESENT (mechanically) but BENIGN. Five consecutive recorded transfers on 2012-07-17 (<24 months) do satisfy the pattern's timing test, and they arguably share a common controller (all Jazz-group entities). However, the signal is designed to flag chained LLCs used to obscure an NPE's identity; here every link resolves to the same public, product-shipping corporate group, and the last transferee is the publicly traded parent's U.S. operating sub. Classify as an internal reorg, not an NPE cascade.

5. Pre-litigation transfer — PRESENT (technically). The chain consolidating title in Jazz Pharmaceuticals, Inc. was recorded 2012-07-17; the first infringement suit naming the '650 patent (Jazz v. Roxane, D.N.J. 2:12-cv-06761) was filed October 26, 2012 — roughly three months later, inside the 6-month window. The signal therefore triggers numerically. Its meaning here differs from the NPE use case: the transferor and transferee are the same corporate family, so this reflects standing/title clean-up to create a clean record for the ANDA litigation, not the importation of a patent by an outside asserter.

6. Bankruptcy fire-sale — NOT PRESENT. Jazz flirted with insolvency around 2009 (per plaintiffs' antitrust pleadings) but never filed, and no bankrupt-estate sale of this patent occurred. The 2021 "release/security agreement" events are refinancing, not a fire-sale.

7. Privateering — NOT PRESENT. Marketing authorizations, the suits (Jazz v. Roxane/Hikma, Amneal, Par, Lupin), and the relevant ANDA/Orange Book listings run in Jazz's own name — Jazz asserts its own patents against actual competitors. No operating-company-to-NPE assignment underlies the assertions.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN; the patent was never neutralized by transfer to a defensive aggregator.

Verdict

Operating-company assertion.

Justification: Every recorded transfer (2012-07-17 intra-group chain; 2012-08-06 Barclays security interest; 2015/2021 BofA and U.S. Bank security agreements and releases) stays inside the Jazz Pharmaceuticals corporate and lender group — there is no assignment to any third-party or licensing-only entity. The terminal holder, Jazz Pharmaceuticals, Inc., is the operating company that manufactures and sells Xyrem (a product embodying the claims) and that sued actual generic competitors on the '650 patent (Jazz v. Roxane, D.N.J. 2:12-cv-06761, filed Oct. 26, 2012 — three months after the 2012-07-17 consolidation of title to Jazz). No shell-entity, known-asserter, bankruptcy, privateering, or defensive-aggregator signal is present; the only open item is the unretrieved correspondent field, which is a data gap, not evidence of an NPE.

Verification links: USPTO Assignment Center · assignment.uspto.gov (search "8263650") · Google Patents legal events for US8263650 · Unified Patents litigation record.

What I could not confirm (stated explicitly, not fabricated): (a) reel/frame numbers for all eleven recorded events; (b) the correspondent/recording attorney and firm for any event; (c) execution dates (distinct from the 2012-07-17 and later recording dates) for the corporate chain — which, if earlier (e.g., ~2005–2008, consistent with JPI Commercial, LLC's 2008 Solvay license), would materially weaken signal 5, since only the recordation would fall three months before the suit. Pull the recorded instruments from the Assignment Center to close these gaps.

I'll search for the cited prior art references on US 8,263,650, focusing on the patent citations (front-page references) rather than similar-numbered patents.

Let me pull the specific front-page patent citations (the "Patent Citations" and "Cited By" tables) for US 8,263,650.

I have the litigation and family context. Now let me pull the actual face-of-patent citations (the PTO-1449 reference list) for US 8,263,650 from the Justia and FreePatentsOnline records.

I was cut off at the research step limit while trying to pull the certified face-of-patent (PTO-1449) citation list. Here is my analysis based on what I did retrieve, with every gap flagged explicitly rather than filled by inference.

Prior Art Analysis — US 8,263,650 B2 (Cook et al.)

Sourcing note (read first)

I could not retrieve the authoritative, face-of-patent "References Cited" / PTO-1449 list for US 8,263,650 from a primary source (USPTO PatentCenter) within the research budget. What follows is reconstructed from three channels, labeled by reliability:

1. The patent's own specification (authoritative text you supplied) — which cites several patent and non-patent documents by name.
2. Aggregator "References Cited" data (Justia, FreePatentsOnline) for the '650 and its family members — secondary, reliable at the number level but not claim-mapped.
3. Litigation documents (paragraphfour.com complaints, PTAB petitions) that identify references challengers raised, which is not the same as examiner-cited art.

A critical, often-missed gate: US 8,263,650's effective priority date is December 23, 1998 (provisional 60/113,745). The '650 is a continuation, so its own 2012 filing did not generate a fresh, narrow prior-art window — the art that matters is art predating Dec. 23, 1998. Several documents that appear on jazz's later family IDSs (e.g., WO 2006/053186, WO 2010/053691, WO 2011/119839, and the Cook family publications) postdate 1998 and therefore cannot be § 102 prior art against the '650's claims, notwithstanding that they appear in sibling-patent reference lists.

A. Confirmed cited patent documents (predating the 1998 priority date)

B. Cited non-patent literature (spec-level, predating 1998)

The '650 spec cites an extensive clinical/pharmacological GHB corpus, all pre-1998 and all § 102/§ 103 background, e.g.: Snead & Morley (1981) (Brain Res. — GHB as neurotransmitter), Mamelak (1977), Broughton & Mamelak (1979), Scharf (1985), Scrima (1990), Gallimberti (1989, 1992, 1993, 1994), Gessa (1992), Ferrara (1992), Palatini (1993), Gerra (1994), Oyama (1970), Strong (1984), plus Remington's.

None of these alone anticipates claims 1, 11, or 15. They establish that GHB was known to treat narcolepsy/cataplexy and other conditions (relevant to the § 102 method claim 11's therapeutic purpose), but not the composition limitations — the ~500 mg/mL concentration, the pH ~7.3–8.5 window, or the "free of preservatives" requirement.

C. References raised by challengers (NOT examiner citations) — the material art

D. Claim-by-claim § 102 bottom line

E. How the '650 was actually attacked (and what that tells you)

• No IPR/PGR/CBM ever targeted the '650 — so no claim was ever tested at the Board (builds on your PTAB section).
• In district court the challengers' validity case was § 103 obviousness plus § 112, layered on the CA 338 inequitable-conduct theory (Roxane), not a clean § 102 anticipation by a single cited patent. Roxane's prayer for relief pleaded invalidity under "§ 101, 102, 103 and/or 112" generically (Jazz v. Roxane, prayer ¶(C)).
• The Examiner cited the '650's own family (the '431/'889/'219/'506 chain) for obviousness-type double patenting, and those references resolve through a terminal disclaimer, not § 102.

Bottom line for the client

1. No cited reference squarely anticipates a '650 claim. The composition claims require a combination — ~500 mg/mL + pH 7.3–8.5 + microbially resistant + chemically stable + preservative-free — that no confirmed examiner-cited reference discloses.
2. The one reference that could threaten § 102 is CA 338, and it was never before the examiner (the inequitable-conduct theory). Verify CA 338's publication date against Dec. 23, 1998 — that single fact determines whether an anticipation theory is viable.
3. Most of the "cited" documents on the family's reference lists are § 103 background or post-1998 non-art. Do not treat the sibling-patent IDS lists (e.g., the 2006–2011 WO publications, the Cook family publications) as prior art against the '650.
4. Practical reality: the '650 expired Dec. 22, 2019 (pediatric exclusivity to June 22, 2020), so any § 102 analysis is now historical/academic for prospective enforcement.

What I could not confirm (stated, not guessed): (a) the complete, certified PTO-1449 list for the '650; (b) the subject matter/date of US 4,983,632, GB 922,029, and DD 237309 A1; (c) CA 338's bibliographic data and publication date — the decisive fact. To close these, pull the PatentCenter file wrapper for application 13/446,940 (the actual PTO-1449s and the examiner's cited art) and, for the litigation theory, the Roxane complaint exhibit reproducing CA 338.

I'll analyze obviousness for US 8,263,650 under § 103. Since I need to ground this in actual prior art, let me search for the references cited against this patent and its family, plus the art in the GHB formulation space.

I have substantial prior-art material from the Amneal/Par/Roxane invalidity contentions and the related IPR petitions. Let me pin down the identity and content of the key formulation references (Gessa, CA 338, the '632 patent, and the German/British patents).

Obviousness Analysis — U.S. Patent No. 8,263,650 under 35 U.S.C. § 103

A. Sourcing note and a flagged discrepancy (read first)

You asked me to "use the results from the Prior Art section of this page." The material supplied to me in this session does not contain a standalone "Prior Art" section — it contains the full patent text, the previously generated sections (summary, litigation, PTAB, assignments), and nothing labeled "Prior Art." Rather than fabricate a reference list, I have substituted the prior art of record for the '650/’431 family, drawn from:

• the references cited on the face of and during prosecution of the '431 family (the '650's ancestors),
• the Amneal/Par/Roxane invalidity contentions and the IPR petitions against the sibling '431-family patent (U.S. 6,472,431) — e.g., https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1459711](/patent/1459711)/ and https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1461686](/patent/1461686)/ (Tarantino Declaration, Ex. 1002), and
• the Roxane inequitable-conduct counterclaim re Canadian Application CA 338, https://paragraphfour.com/uploads/cases12/njdc12cv6761A.pdf.

Flag: this is not the same thing as a validated "Prior Art section," and I could not confirm the exact publication dates of two key references (Gessa and CA 338). I mark date-dependent conclusions as conditional below.

Second flag (a trap in the record): Much of the § 103 argumentation in the public filings (e.g., the Jazz v. Avadel expert report, https://storage.courtlistener.com/recap/gov.uscourts.njd.[478299](/patent/478299)/gov.uscourts.njd.478299.244.2.pdf) reasons "obvious over Cook." In those briefs, "Cook" is the '431 family itself (US 6,472,431 and its continuations/EP 1316309), used as prior art against Jazz's later patent filings (the '102, '922, '373 mixed-salt patents claiming priority to 2013). Cook is NOT prior art to the '650, because the '650 and Cook share the same inventors, specification, and 1998 priority. Anyone importing the "obvious over Cook" analysis into a '650 analysis is making a category error. The correct prior art for the '650 is the pre-December 23, 1998 art listed below.

B. Effective filing date and the level of ordinary skill

Effective filing date: December 23, 1998 (provisional 60/113,745), via the chain 09/470,570 → 6,472,431 → continuations/divisionals → 13/446,940. Prior art must therefore predate Dec. 23, 1998 (§ 102(a)) or Dec. 23, 1997 (§ 102(b)).

Critical § 103 threshold issue. Claim 11's "diluting…and administering" step and the "about 7.3 to about 8.5" pH range of claim 1 were added in the 2012 continuation. If those limitations are not supported by the 1998 provisional/'431 disclosure, the claims get only a 2012 effective date, and the entire published Xyrem® label / commercial product (508A, approved 2002) — which expressly discloses "500 mg of sodium oxybate per milliliter… neutralized to pH 7.5 with malic acid" — becomes § 102/§ 103 prior art that anticipates or renders obvious claim 1 essentially outright. Roxane's antitrust complaint alleges precisely that Jazz "invented" these claims in 2012 after learning Roxane's non-infringement positions (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1459711/ — Roxane counterclaim ¶¶ 16–21). This support question should be resolved before any detailed § 103 merits analysis; it can change the universe of prior art.

PHOSITA: a formulation scientist (B.S./M.S./Ph.D. in pharmaceutics or chemistry) with ~2–5 years' experience developing liquid oral and injectable pharmaceutical solutions, familiar with USP〈51〉antimicrobial-effectiveness testing, ICH stability guidance, and standard excipients (pH adjusters, buffers, preservatives).

C. The prior art of record (for the '650's Dec. 23, 1998 date)

The hyperosmolarity teaching is important and is captured in the record by Jazz's own admissions and the Tarantino declaration (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1461686/): a 250–500 mg/mL sodium-GHB solution is ~5,575–11,166 mOsm/L (vs. 308 for 0.9% saline), and "[a] concentration of salt much above 1% is harmful to many bacteria" (WCK1034). The '431/'650 specification itself admits that GHB solutions >150 mg/mL are "suitably resistant to microbial contamination" across pH 3–9.

D. Claim 1 (composition) — element mapping

Claim 1 (as reproduced in the previously generated section): an aqueous solution of about 500 mg/mL sodium GHB, pH about 7.3–8.5, chemically stable, resistant to microbial growth, and free of preservatives.

Every limitation of claim 1 is disclosed or rendered obvious by the combination of Vickers/'632 (preservative-free aqueous sodium GHB solution) + Gessa (concentration up to 500 mg/mL) + CA 338 (preservative-free pH 7.2–7.7 stable, microbially resistant solution).

E. The candidate § 103 combinations and the motivation to combine

Ground 1 (primary) — Vickers 1969 (or the '632 patent) in view of Gessa, further in view of CA 338

Rationale (KSR-permissible):

1. Same field, same problem, finite predictable set of variables. Vickers and the '632 patent both teach aqueous, preservative-free sodium-GHB solutions for human use at physiological pH. The only differences from claim 1 are degree — a higher concentration (~500 vs. 242–302.5 mg/mL) and a pH landing in 7.3–8.5. Eaton/KSR: optimizing concentration and pH of a known solution is routine.
2. Articulated design incentive. The '650's own background concedes the motivation: "a chronically used product which requires high levels of drug, the volume of a non-concentrated product creates cost and handling issues." A POSA had a stated reason to concentrate (reduce volume/shipping/storage, patient convenience) — exactly the problem the patent purports to solve.
3. Predictable self-preservation. Because a 250–500 mg/mL GHB solution is hyperosmotic (~18–36× saline) and "a concentration of salt much above 1% is harmful to many bacteria," a POSA would reasonably expect a 500 mg/mL solution to be self-preserving without a preservative — supplying the "free of preservatives" and "resistant to microbial growth" limitations with a reasonable expectation of success.
4. pH selection is a recognized result-effective variable. Avoid GBL formation (needs pH > 6; pKa 4.72 from the 1990 CRC Handbook), maintain physiological tolerability (Vickers' pH 8.2–8.9; '619's "slightly in excess of 7"; CA 338's 7.2–7.7). The claimed 7.3–8.5 window is literally the overlap of the prior-art windows → In re Peterson/In re Woodruff (overlapping ranges obvious absent unexpected results).

Ground 2 (dependent claims 2–4) — Ground 1 + pre-selected pH points

Claims 2 (pH ≈7.5), 3 (≈8.0), 4 (≈8.5) are individual points inside a range the primary art already discloses (Vickers 8.2–8.9; CA 338 7.2–7.7). Selecting pH 7.5–8.5 is routine optimization with no asserted criticality.

Ground 3 (dependent claims 5–10) — Ground 1 + 1995 USP / Nema et al.

Claims 5–10 add a pH-adjusting/buffering agent (acid; organic/inorganic; malic, citric, acetic, boric, lactic, HCl, phosphoric, sulfuric, nitric; malic acid in claim 10). The 1995 USP lists malic, citric, acetic, propionic, and tartaric acids as accepted pharmaceutical acidifying agents; Nema provides a 32-entry buffer/pH-adjuster table. A POSA titrating a sodium-GHB solution (native pH ≈9–10) down to 7.3–8.5 would obviously reach for a GRAS, taste-compatible acid; malic acid is specifically disclosed as the preferred acid in the '431 family and is the acid in the commercial Xyrem® product. Predictable result, known components for known purposes.

Ground 4 (method claims 11–14) — GHB narcolepsy art + dilution/dosing art

Claim 11 = dilute the claim-1 composition, then administer to treat cataplexy or daytime sleepiness in narcolepsy. Claims 12–14 add oral dosing; two consecutive doses daily; first before bedtime, second ≈2.5–4.0 h later.

• Treating narcolepsy/cataplexy with GHB was old: Mamelak 1977, Broughton & Mamelak 1979, the '236 patent, Gessa. Motivation is inherent (the disease indication).
• Dilution before administration was old: Mamelak 1977 administered the GHB syrup diluted in water; multi-dose liquid GHB solutions were known (Gessa, EP '804). The '650 specification itself markets the liquid as "diluted with water immediately prior to oral administration."
• Twice-nightly dosing was the established regimen: Broughton & Mamelak's nocturnal protocol, and the '650's own Example 4 describes the "generally ingested the first dose … prior to bedtime and the second dose from 2.5 to 4.0 h later" regimen as conventional.
• KSR "obvious to try" supplies the rest: a POSA seeking a titratable oral GHB dose would predictably dilute a concentrated solution and administer it on the known two-dose nightly schedule.

Ground 5 (kit claims 15–18) — Ground 1 + conventional pharmaceutical packaging

Claims 15–18 claim a set comprising the composition in one or more container means (drinking cup, dosing cup, syringe, pipette, vial, ampule, test tube, flask, bottle, pouch) with diluent handling. The '431-family specification itself describes such sets, and packaging a liquid pharmaceutical in a vial/bottle/pouch is the definition of routine. The twin-pouch (drug + excipient) packaging is disclosed in the '650's own Example 4. No patentable weight attaches to an old composition in an old container.

F. Why a POSITA would combine (the "motivation" element, consolidated)

G. Rebuttals Jazz would raise, and how they fare

1. "Unexpected result: self-preservation without preservatives." This is the strongest Jazz argument (and the basis of the '431 prosecution statements, quoted in https://ptacts.uspto.gov/ptacts/public-informations/petitions/1459711/). It is materially weakened by (a) the '650's own admission that >150 mg/mL is "suitably resistant to microbial contamination," (b) the prior-art preservative-free GHB injectables, and (c) the express the-art hyperosmolarity teaching. A Graham secondary-considerations showing would need to tie the antimicrobial self-preservation to the claimed 500 mg/mL / pH 7.3–8.5 window specifically, not to concentration generally.
2. "Teaching away from preservative-free at high ionic strength / from the claimed pH." No reference teaches away; the art brackets the claimed window.
3. "Commercial success / long-felt need (Xyrem®)." Weak in the § 103 setting for a regulated drug (Merck v. Teva), and any success is attributable to GHB's known efficacy (the "blocking" prior art), not to the pH/concentration parameters.
4. CA 338 inequitable conduct (materiality = § 103). Independent of the § 103 merits, Roxane pleaded that CA 338 — a preservative-free, pH 7.2–7.7, stable, microbially resistant sodium-GHB solution — is squarely on point for claim 1 and was withheld (https://paragraphfour.com/uploads/cases12/njdc12cv6761A.pdf, ¶¶ 24–41). If CA 338 qualifies as prior art by date, it is arguably the single most damaging reference to claim 1 (it aligns pH, preservative-free status, and microbial resistance).

H. Bottom line

• Claim 1's formulation is prima facie obvious over Vickers 1969 / U.S. 4,983,632 in view of Gessa and CA 338 (and the '619, EP '804, '236, '937, British 922,029 and DD 237,309 references), because every element — aqueous sodium GHB, ~500 mg/mL, pH 7.3–8.5, chemically stable, microbially resistant, preservative-free — is disclosed or is a predictable optimization of a small, enumerated set of formulation variables, with a documented design incentive (concentration) and a documented mechanistic expectation (hyperosmotic self-preservation, GBL pH floor).
• Claims 2–10 are obvious over Ground 1 plus the 1995 USP/Nema acidulant teachings (malic acid the predictable selection).
• Claims 11–14 are obvious over Ground 1 in view of the narcolepsy GHB art (Mamelak 1977; Broughton & Mamelak 1979) plus the admitted dilute-then-administer, twice-nightly regimen.
• Claims 15–18 are obvious as conventional packaging of an obvious composition.
• Strongest single-reference risk: CA 338 (date-dependent) — preservative-free, pH 7.2–7.7, stable, microbially resistant sodium-GHB solution.
• Overarching validity caveat: if claim 11's dilution step (and/or claim 1's pH range) lacks § 112 support in the 1998 priority document, the claims take a 2012 date, and the Xyrem® label (500 mg/mL, pH 7.5 w/ malic acid) alone anticipates/makes obvious claim 1.

Caveats (stated, not fabricated): (1) No "Prior Art" section was supplied; the above is reconstructed from the family's cited art and the Amneal/Par/Roxane § 103 record. (2) I did not confirm the publication dates of Gessa and CA 338, so grounds relying on them are conditional on those dates falling before Dec. 23, 1998 — verify at the USPTO/DOC before relying. (3) Exact claim language is from the third-party reproduction in the previously generated summary; confirm against the USPTO text of 13/446,940. (4) The '650 is expired (Dec. 22, 2019) and was never subjected to an IPR/CBM, so this § 103 record was developed in district court, not at the PTAB (see the previously generated PTAB section) — there is no § 315(e)(2) estoppel to leverage.