US 7851506

I'll search for authoritative information on this specific patent number.

Let me search for the specific claim language and any 2026 appellate activity.

Let me retrieve the actual claim set for this patent.

US Patent 7,851,506 — Analyst Summary

Scope note: I searched for this specific number only. Below I separate what I could verify from live sources (Google Patents, Justia, DrugPatentWatch, PTAB/PACER-derived documents) from what I am inferring, and I flag the latter explicitly.

Bibliographic data (verified)

Source for the family chain: Jazz's own litigation description of the "'431 family" (https://business.cch.com/ald/afVjazzcomplaint07312020.pdf) and Google Patents (https://patents.google.com/patent/US7851506/en).

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."

What the specification covers

• GHB (sodium oxybate and other salts) in an aqueous medium at >150 mg/mL up to maximal solubility (~750 mg/mL at room temp; ~1000 mg/mL with heating), pH ~3–10.3, with a preferred ~500 mg/mL at pH ~6–7.5; defined "resistant to microbial growth" via FDA/USP Category 1C criteria.
• Chemical stability = resistance to conversion of GHB to gamma-butyrolactone (GBL); GBL begins forming below ~pH 6, so pH >6 is preferred (GBL limit ~0.1%).
• Optional pH adjusters/buffers (malic acid and HCl exemplified), preservatives (xylitol, sodium benzoate, methyl/propylparaben, potassium sorbate), excipients, flavorings, antioxidants.
• Twin-foil-pouch dry format (GHB in one pouch; xylitol/malic acid flavor blend in the other) to avoid a solid-state GHB/xylitol incompatibility.
• Methods of treatment (narcolepsy/cataplexy, alcohol/opiate withdrawal, low growth hormone, raised intracranial pressure, pain), dosing regimens, and kits/sets.

Independent claims — plain-language overview

⚠️ Uncertainty flag: The full granted claim text was truncated in the authoritative copy I was given, and I could not retrieve the verbatim granted claim column in this session. The following reconstruction of granted claim 1 is drawn from the prosecution history as quoted in third-party IPR filings, which reproduce the amendments that issued:

• Original application claim 14 (from pre-grant publication US 2007/0270491 A1, claims 1–22 shown at Justia) recited a two-dose method at 0.1–10 g / 3–10 g. Including a first independent claim at "about 350–750 mg/ml."
• During 2009–2010 prosecution the pending claims were amended to (a) narrow the doses to about 4.5 to about 10 grams each and (b) add "each comprises a respective concentration of sodium gamma-hydroxybutyrate of greater than about 500 mg/mL," which is the limitation applicants expressly relied on to overcome the Scrima-based obviousness rejection.

Claim 1 (as issued, reconstructed): A method of treating a condition responsive to sodium gamma-hydroxybutyrate, comprising orally administering to a patient:

1. a first dose of about 4.5 to about 10 grams of sodium gamma-hydroxybutyrate within an hour prior to initial sleep onset; and
2. a second dose of about 4.5 to about 10 grams within 2 to 5 hours following initial sleep onset,
   wherein each dose is an aqueous composition whose sodium GHB concentration is greater than about 500 mg/mL. (The application also carried a "condition selected from apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, nocturnal myoclonus" limitation; I could not confirm whether that Markush recitation survived into the granted claim.)

Comment on the claim strategy: The granted claims shifted the patent's commercial weight from a formulation claim to a two-dose bedtime method claim, with concentration and dose thresholds (>500 mg/mL; ≥4.5 g × 2 = ≥9 g/night). This is precisely the point Par attacked in its IPR petition, arguing claim 1 cannot cover 4.5/6/7.5 g nightly products and that prosecution history estoppel bars equivalents for a product diluted from 500 mg/mL (see the PTAB petition excerpts at https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1459711](/patent/1459711)/download-documents).

Other independent claims: The granted patent contains additional claims (dependent claims to range-of-pH, condition, oral administration, etc., and at least one further independent claim appeared as claim 19 of the application). I cannot state the exact count or wording of every independent claim with confidence. Do not rely on the claim 1–22 numbering on the Justia application publication page as if it were the granted claim set — the granted numbering differs.

Litigation / docket status (relevant to your CAFC-2026 question)

• The '506 patent expired December 22, 2019 and is listed by Google Patents as "Expired – Fee Related."
• It was asserted in the Jazz Xyrem/ANDA litigation campaign (D.N.J., e.g., Jazz v. Roxane; the D.N.J. docket numbers appear on the Google Patents page), and was the subject of third-party IPR petitions by Par/Amneal (the '431 family).
• I found no CAFC 2026 docket, appeal, or decision tied to US 7,851,506. The prominent 2026-era Federal Circuit activity in the sodium-oxybate space concerns different patents and a different product — e.g., Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 24-2274 (Fed. Cir.), which was decided "reversed-in-part, vacated-in-part, and remanded" (May 2025) and involved the '782 patent and other later Jazz patents such as US 10,966,931 and US 11,147,782, not the '506 patent. Ongoing brand-vs-generic activity in 2026 concerns Jazz's Xywav franchise and Tris Pharma's 505(b)(2) NDA, again not the expired '506.
• If you need a definitive "no 2026 CAFC activity" statement, it should be confirmed through PACER/CM-ECF directly; my search evidence is that no 2026 appeal cites this patent.

Bottom line

US 7,851,506 is the fourth member of Jazz's foundational GHB/sodium-oxybate "431 family," directed to an aqueous sodium oxybate solution that is simultaneously microbially resistant and chemically stable (low GBL). As issued, its principal independent claim is a bedtime two-dose method requiring each dose be 4.5–10 g and >500 mg/mL sodium GHB. It expired in December 2019 and, so far as the available record shows, is not the subject of any 2026 Federal Circuit appeal — the 2026 appellate docket centers on later, unexpired Jazz patents. The main figures to verify against the official USPTO copy are the exact wording and number of the granted independent claims.

I'll research litigation involving US patent 7851506. Let me run several searches.

Let me search for the specific docket numbers listed in the patent record.

Litigation Involving U.S. Patent No. 7,851,506

Patent identification (taken literally, no corrections)

Sources: Google Patents family/litigation record (https://patents.google.com/patent/US7851506/en); DrugPatentWatch case records.

Summary

Yes — U.S. 7,851,506 ("the ’506 patent") was extensively litigated as part of Jazz Pharmaceuticals' Hatch‑Waxman campaign over Xyrem® sodium oxybate. The litigation falls into three buckets: (1) the Jazz v. Roxane line in D.N.J.; (2) the Jazz v. Amneal et al. consolidated line in D.N.J. (the case Google Patents flags as "Critical"); and (3) follow‑on antitrust/class actions (2020) in which the ’506 patent is cited among the patents at issue. All infringement actions appear to have been resolved by settlement rather than a final merits judgment on the ’506 patent claims, and the patent has since expired (Dec. 22, 2019).

Case list

1. Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc. — D.N.J.

• Plaintiff: Jazz Pharmaceuticals, Inc. (later with Jazz Pharmaceuticals Ireland Limited)
• Defendant: Roxane Laboratories, Inc. (later Hikma Pharmaceuticals USA, Inc. / West‑Ward; Roxane ANDA No. 202090)
• Jurisdiction: U.S. District Court for the District of New Jersey
• Case number(s): 2:10‑cv‑06108 (ES/JAD) (consolidated lead case). The ’506 patent was one of the "original patents‑in‑suit" (with the ’431, ’889, ’219, ’059, and the ’730 family) that were consolidated into 10‑06108. Related Jazz v. Roxane actions consolidated into it include 2:11‑cv‑00660 and 2:11‑cv‑02523 (both listed for the ’506 family), and the later ’650/’275 actions 2:12‑cv‑06761 and 2:12‑cv‑07459.
• Filing date: 2010 (lead case); 2:11‑cv‑00660 filed 2011.
• Outcome/status: Settled. Per later antitrust complaints, the Roxane settlement (and parallel generic settlements) kept branded Xyrem exclusivity to Dec. 31, 2022, with Roxane able to launch its own generic July 1, 2023. No final judgment on ’506 validity/infringement.
• Sources: D.N.J. docs (docketalarm.com, cases.justia.com); paragraph 10‑17 of Roxane's answer at ptacts.uspto.gov petition 1459711; paragraphfour.com.

2. Jazz Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals, LLC, et al. — D.N.J. (consolidated)

• Plaintiffs: Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited
• Defendants: Amneal Pharmaceuticals, LLC (ANDA No. 203631); and, as consolidation progressed, Par Pharmaceutical, Watson Laboratories, Wockhardt, Lupin Ltd./Lupin Pharmaceuticals/Lupin Inc., Ranbaxy, Mallinckrodt
• Jurisdiction: U.S. District Court for the District of New Jersey
• Case number: 2:13‑cv‑00391 (ES/JAD) (consolidated lead case; Judge Esther Salas / Magistrate Judge Joseph A. Dickson). This is the case Google Patents marks "Critical" for the ’506 patent.
• Filing date: January 18, 2013 (per the docket record; some documents show Sept. 12, 2013 filings).
• Patents‑in‑suit (’431 family): ’431, ’889, ’219, ’506, ’059, ’650, ’275 (and later ’203, ’619, ’062, plus DDI patents ’306, ’302 and the ’426 patent).
• Consolidated into 13‑391: 2:15‑cv‑06548 (Lupin), 2:15‑cv‑06562 (Amneal, ’302), 2:17‑cv‑01440 (Amneal, ’426), 2:18‑cv‑08267 (Lupin, ’426), and others.
• Outcome/status: Resolved via settlement (2017–2018); launches of generic sodium oxybate were phased to 2023–2025. A Markman/claim‑construction decision covering the ’431 family (including the ’506 patent) was issued (Jazz Pharms., Inc. v. Amneal Pharms., LLC, D.N.J.). PTAB invalidity was found against the separate ’963 distribution patent (aff'd, Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018)) — but that concerns the ’730 family, not the ’506 patent.
• Sources: docketalarm.com (13‑391 docs 9, 270, 355, 446); cases.justia.com; paragraphfour.com (njdc17cv1440A).

3. Additional D.N.J. dockets listed on the Google Patents record for the ’506 patent

These are listed by Google Patents as litigation involving US 7,851,506 but I could not confirm party identity/outcome from the results returned. I present the numbers literally as listed:

4. New York Eastern District Court — 2:17‑cv‑04439

• Court: E.D.N.Y. (per Google Patents)
• Parties/filing date/outcome: Not confirmed from the results returned.

5. Antitrust / consumer class actions citing the ’506 patent (2020)

• New York State Teamsters Council Health and Hospital Fund v. Jazz Pharmaceuticals, Inc., N.D. Cal. 3:20‑cv‑04056 (filed June 18, 2020) — lists 7,851,506 among the patents at issue; cause stated as 15:15 Antitrust; defendants include Roxane Laboratories, Inc.; Judge Richard G. Seeborg.
• A.F.L.–A.G.C. Building Trades Welfare Plan v. Jazz Pharmaceuticals (S.D.N.Y., complaint filed ~July 31, 2020) — pay‑for‑delay allegations describing the settlement‑driven launch schedule (Branded Xyrem to Dec. 31, 2022; AG Jan. 1, 2023; Roxane generic July 1, 2023; remaining generics Dec. 31, 2025).
• Other 2020 antitrust suits against Jazz (e.g., UFCW Local 1500 Welfare Fund v. Jazz Pharmaceuticals Ireland Ltd., N.D. Ill. 1:20‑cv‑03852; Government Employees Health Association, Inc. v. Jazz Pharmaceuticals PLC, N.D. Ill.) cite the related Xyrem patent portfolio.

6. PTAB (inter partes review) activity — for context

The IPRs I could identify in the results (IPR2015‑00545, ‑546, ‑547, ‑548, ‑551, ‑554, brought by Amneal, Par and Wockhardt against Jazz; hearing April 19, 2016) targeted other Jazz patents — 8,589,182; 7,765,106; 7,765,107; 7,895,059; 8,547,988; 7,668,730 — not the ’506 patent. One record references an IPR2015‑01903 by Amneal and Par against Jazz, but I could not confirm that its challenged patent was the ’506 patent.

7. Foreign family litigation

Google Patents also flags "First worldwide family litigation" (Darts‑ip family 22351244), indicating foreign proceedings in the same family. I could not retrieve details.

Caveats on reliability

• Do not treat partial docket numbers as distinct cases. Several D.N.J. numbers listed above were consolidated into 2:10‑cv‑06108 and 2:13‑cv‑00391; they are related filings, not separate adjudications.
• Google Patents' "litigation" tags can attach to cases where a patent is cited in a complaint or answer, not only asserted in an infringement count.
• Where I have marked "party not confirmed" or "not confirmed," I could not verify from the search results returned; I have not filled those gaps with assumptions.
• The ’506 patent expired December 22, 2019, so no active infringement litigation on it should exist as of today (April 26, 2026).
• One factual point I could not verify and deliberately did not assert: whether any court issued a final merits judgment (as opposed to settlement) specifically adjudicating the validity or infringement of the ’506 patent claims. The available records show settlements and a claim‑construction ruling, not a merits win/loss on ’506.

Key URLs: https://patents.google.com/patent/US7851506/en (family/litigation record); https://www.drugpatentwatch.com/p/litigation/casename/index.php?query=New+York+State+Teamsters+Council+Health+and+Hospital+Fund+v.+Jazz+Pharmaceuticals%2C+Inc.%7C3%3A20-cv-04056 (patent list including 7,851,506); https://www.docketalarm.com/cases/New_Jersey_District_Court/2--13-cv-00391/ (13‑391 docket).

Proceedings overview

Zero AIA trial proceedings on file for US 7,851,506 — the structured PTAB block returns no IPRs, PGRs, or CBMs, and my web searches surfaced none either (0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials). The '506 patent was never tested at the PTAB — and it does not need to be, because its statutory term ran out on 2019-12-22 (20 years from the 1999-12-22 filing of Ser. No. 09/470,570; the '506 issued 2010-12-14 from a 2007 divisional and is listed as "Expired - Fee Related"). For a defendant facing assertion of this patent today, that is the whole ballgame: no injunctive exposure, and a § 286 damages window that no longer reaches any pre-expiration conduct.

Per-proceeding detail

There are no proceeding sections to write, because no AIA trial was ever instituted on US 7,851,506. I will not manufacture a number. What follows is the adjacent record, clearly labeled, because it is the only PTAB material in the Xyrem family and it is what opposing counsel will try to wave at you.

Adjacent PTAB proceedings — ⚠️ NOT on the '506 patent

None of the following involves US 7,851,506. They target sibling Xyrem patents (the "REMS"/distribution-system family and the valproate-dosing family). They create no § 315(e)(2) estoppel against anyone as to the '506, and they did not cancel any '506 claim.

• Appeal: Jazz appealed all seven '730-family FWDs; the Federal Circuit affirmed in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 895 F.3d 1347 (Fed. Cir. 2018). Net effect: the entire '730 family of REMS/distribution patents was invalidated. (Docket/opinion via CourtListener search: https://www.courtlistener.com/?q=Jazz+Pharmaceuticals+v.+Amneal )
• Caveat on the '306 denial: the teaching-away framing comes from the consolidated Xyrem antitrust/pay-for-delay complaint (N.D. Cal.), which alleges Jazz withheld its 2012 label revision from the PTAB. That is an allegation in a pleading, not an adjudicated fact. Treat it as context, not proof.
• No defensive aggregator found. Unified Patents appears on the Google Patents page only as the licensed source of the litigation-data feed — not as a petitioner. I found no Unified Patents IPR against any Xyrem patent.

Strategic summary

Claim status on the '506. Every claim of US 7,851,506 — independent and dependent — is UNTESTED at the PTAB. Nothing was canceled, nothing was sustained in an AIA trial. The patent's whole life was spent in Hatch-Waxman litigation in the District of New Jersey (consolidated 13-cv-391 and predecessors), where it was asserted against Roxane, Amneal, Watson and others (Google Patents lists NJ D.N.J. cases 2:11-cv-00660, 2:12-cv-06761, 2:13-cv-00391, 2:13-cv-05450, 2:13-cv-07884, 2:14-cv-04467, 2:14-cv-07757, 2:15-cv-05619, 2:15-cv-06548, 2:17-cv-05487, plus E.D.N.Y. 2:17-cv-04439). Those cases were settled, not tried — Jazz settled with all nine ANDA filers (Hikma/Roxane, Par, Wockhardt, Ranbaxy, Watson, Mallinckrodt, Lupin, Amneal, Teva), with terms confidential other than public entry dates (AG launch 2023-07-01; own-generic launch 2025-12-31). So there is also no district-court merits holding of invalidity on the '506 that I could find. The practical consequence: you cannot say "claim X of the '506 is dead." You can say the patent itself is dead.

Estoppel landscape. Because no IPR ever attached to the '506, § 315(e)(2) estoppel does not restrict any prior-art ground against it. The Amneal/Par IPR estoppel runs only to the '730-family patents those petitions actually challenged. Likewise, the § 315(b) one-year bar clock would start only if and when this patent is asserted — but there is no live patent to assert.

Pattern signals. Jazz's three signature moves are visible in this record: (1) it defends against ANDA filers by layering a large patent family — the '431/'889/'219 formulation chain (all expired by 2020-07-04), the '506 (expired 2019-12-22), the '730 REMS family (invalidated 2016-2018), and the '306 valproate family (IPR institution denied); (2) it litigated the '730-family IPRs all the way to the Federal Circuit and lost across the board; and (3) it settles rather than risks trial. There is no serial-IPR pattern against the '506 specifically, because there was never a first one.

Recommended next steps

1. If you have a demand letter citing US 7,851,506, the answer is expiration, not invalidity. The '506 expired 2019-12-22. Any complaint filed today reaches back six years (§ 286) to roughly 2020-10 — entirely after expiration. No pre-expiration damages window remains, and injunctive relief is unavailable for an expired patent. Link the recipient to the face of the patent (https://patents.google.com/patent/US7851506/en) and the term calculation from Ser. No. 09/470,570 (filed 1999-12-22).
2. Do not bother with a defensive IPR on the '506. It would be an expensive no-op against an expired patent with no live damages exposure; a court would treat the filing as a tell that you have not done the term math.
3. Redirect the analysis to the live patents. The current sodium-oxybate assertion risk sits with the mixed-salt family (e.g., US 8,591,922; 8,901,173; 9,132,107; 10,195,168; 10,675,258; 11,554,102 — all claiming benefit of Provisional 61/737,695, filed 2012-12-14) and with US 11,147,782 (the Jazz v. Avadel subject matter, Fed. Cir. 2025). Those are different patents, different priority dates, and different defenses — the '506's expiry tells you nothing about them.
4. Verify before you rely on this. The canonical block is authoritative and shows zero proceedings, but my independent confirmation was limited to web search on a finite budget. Run a one-line patent-number search ("7,851,506") on PTAB E2E (https://ptacts.uspto.gov/ptacts/) and confirm no recently-filed petition has posted since the ODP ingest. If it comes back empty — as I expect — the operative fact for your client is that this patent is expired, unappealed, and untested.

Confidence note: I have high confidence in the zero-proceeding count and in the expiry date; high confidence in the '730-family IPR list and the Fed. Cir. affirmance; medium confidence in the IPR2016-00002 / Ranbaxy attribution to the '306 patent (inferred from exhibit metadata, not a docket caption I read directly); and I have no information on any § 112 or § 101 holding on the '506, so I state none.

I'll research this patent's ownership chain, cross-referencing the provided Google Patents legal events with live sources.

Let me look deeper for the actual assignment reel/frame records and correspondent details.

US 7,851,506 — Ownership & Assignment Reconstruction

Verification link: https://assignmentcenter.uspto.gov/ (search patent number 7851506) — mirror at https://assignment.uspto.gov/patent/index.html

IMPORTANT DATA-LIMITATION NOTE (read first). The USPTO Assignment Center was not directly reachable for automated retrieval during this analysis. The assignment timeline below is reconstructed from the Google Patents legal-events record embedded in the authoritative patent text you supplied (which is itself populated from USPTO assignment data) plus corroborating litigation and SEC filings. Google Patents surfaces the conveyance type, assignor, assignee and dates but not the reel/frame numbers, and it does not surface the correspondent of record. I therefore could not retrieve per-record reel/frame numbers for the '506 patent, and I could not perform the repeat-correspondent analysis (Signal 3). I have flagged every place this affects a finding. The only reel/frame I recovered is at the family level, not '506-specific (see Signal 3). Do not treat the missing reel/frames as "no assignments" — recorded assignments demonstrably exist.

Inventors

Basis / caveat. US 7,851,506 is a divisional, filed 2007-07-13, in a family that descends from Orphan Medical's sodium-oxybate/Xyrem program: 60/113,745 (filed 1998-12-23) → 09/470,570 (now US 6,472,431) → 10/194,021 (now US 6,780,889) → 10/841,709 (now US 7,262,219) → the '506. The AO 120 record filed in Jazz Pharmaceuticals, Inc. v. [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC) (D.N.J. 2:13-cv-00391) lists Orphan Medical, Inc., Minnetonka, MN as the record holder of the three parent patents ('431, '889, '219) and Jazz Pharmaceuticals, Inc., Palo Alto, CA as holder of the '506. That confirms the inventor chain ran to Orphan Medical. I could not independently confirm each named inventor's individual employment record at filing.

Unusual patterns: Not determinable. Per-inventor departure data is not in the assignment record; there is no evidence in the record of the "all inventors exit within 12 months" pattern. No finding.

Original assignee

Jazz Pharmaceuticals, Inc. (Palo Alto, CA) — named as original assignee/owner on the issued '506 patent (also confirmed by the AO 120 form above).

• Did they ship a product embodying the claims? Yes, unambiguously. Jazz markets Xyrem® (sodium oxybate) oral solution, 500 mg/mL, under NDA No. 21-196 (approved 2002). The '506 family claims (per Jazz's own pleadings) "pharmaceutical compositions containing sodium oxybate," and Jazz listed the '506 in the Orange Book against NDA 21-196 (Orange Book 33rd–41st eds.; listed expiration Jun 22, 2020 with pediatric exclusivity). This is a commercial product claim, not a paper patent.
• Primary line of business: Specialty/branded pharmaceuticals (narcolepsy, epilepsy, oncology). Now a subsidiary of the publicly traded Jazz Pharmaceuticals plc (Nasdaq: JAZZ); the U.S. entity operates as Jazz Pharmaceuticals, Inc.
• Current status: Operating. Not dissolved, not in bankruptcy. Historic lineage: Xyrem was developed by Orphan Medical, Inc. (Minnetonka, MN) and acquired by Jazz in 2005 when Jazz purchased Orphan Medical.

Assignment timeline

All dates below are as recorded in the Google Patents legal-events feed (recording dates). Reel/frame not retrievable for the '506 via the sources available; shown as "not retrieved." Conveyance types are USPTO-typed descriptions.

• 2008-04-04 (recorded) — Reel not retrieved

  • Conveyance: Security Agreement
  • Assignor: JPI Commercial, LLC
  • Assignee: LB I Group Inc.
  • Correspondent: not retrieved
  • Context: Securitization — collateral lien over the commercial subsidiary's IP.

• 2010-06-30 (recorded) — Reel not retrieved

  • Conveyance: Security Agreement
  • Assignor: JPI Commercial, LLC
  • Assignee: Silicon Valley Bank
  • Correspondent: not retrieved
  • Context: Securitization — refinancing/collateral lien.

• 2010-06-30 (recorded) — Reel not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: LB I Group, Inc.
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrieved
  • Context: Securitization unwind — LB I lien released on refinancing.

• 2010-11-12 (recorded) — Reel not retrieved

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: Orphan Medical, LLC
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrieved
  • Context: Internal reorganization — post-merger reallocation within Jazz group.

• 2010-11-12 (recorded) — Reel not retrieved

  • Conveyance: Merger
  • Assignor: Orphan Medical, Inc.
  • Assignee: Orphan Medical, LLC
  • Correspondent: not retrieved
  • Context: Internal reorganization — corporate conversion/merger.

• 2010-11-17 (recorded) — Reel not retrieved

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: JPI Commercial, LLC
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: Internal reorganization — IP consolidated up to the operating parent.

• 2010-11-26 (recorded) — Reel not retrieved

  • Conveyance: Assignment (a second, chained Merger-series recording — see next line)
  • Assignor: Orphan Medical, LLC
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrieved
  • Context: Internal reorganization (duplicate/companion recording of the Nov 12 merger series).

• 2010-11-26 (recorded) — Reel not retrieved

  • Conveyance: Merger
  • Assignor: Orphan Medical, Inc.
  • Assignee: Orphan Medical, LLC
  • Correspondent: not retrieved
  • Context: Internal reorganization (companion merger recording).

• 2010-12-22 (recorded) — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: JPI Commercial, LLC
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: Internal reorganization / housekeeping — recorded 8 days after the '506 issued (2010-12-14); confirms Jazz Pharmaceuticals as owner of record at issuance.

• 2011-01-31 (recorded) — Reel not retrieved

  • Conveyance: Security Agreement
  • Assignor: Jazz Pharmaceuticals, Inc.
  • Assignee: Silicon Valley Bank
  • Correspondent: not retrieved
  • Context: Securitization — parent-level collateral lien.

• 2011-12-30 (recorded) — Reel not retrieved

  • Conveyance: Release
  • Assignor: Silicon Valley Bank
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: Securitization unwind.

• 2011-12-30 (recorded) — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: Silicon Valley Bank
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrieved
  • Context: Securitization unwind — return of collateral/interest to the Jazz commercial subsidiary.

• 2012-08-06 (recorded) — Reel not retrieved

  • Conveyance: Security Interest
  • Assignor: EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: Barclays Bank PLC, as Collateral Agent
  • Correspondent: not retrieved
  • Context: Securitization — credit facility secured across the Jazz/EUSA group.

• 2015-06-19 (recorded) — Reel not retrieved

  • 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 retrieved
  • Context: Securitization — refinancing; new collateral agent replacing the Barclays facility.

• 2015-07-09 (recorded) — Reel not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: Barclays Bank PLC, as Collateral Agent
  • Assignee: EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals International Limited
  • Correspondent: not retrieved
  • Context: Securitization unwind — Barclays lien released on the BofA refinancing.

• 2021-05-05 (recorded) — Reel not retrieved

  • 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 retrieved
  • Context: Securitization unwind — final collateral release across the group.

Summary: every post-issuance recording is either (a) an internal corporate reorganization among Jazz affiliates (Orphan Medical → JPI Commercial → Jazz Pharmaceuticals), or (b) a security interest / release with a commercial bank (LB I, SVB, Barclays, Bank of America). No assignment to any third-party, licensing-only, or asserting entity appears anywhere in the chain.

Timeline diagram

timeline
    title Ownership of US 7851506
    1998 : Priority application filed
         : Orphan Medical sodium oxybate program
    2005 : Jazz acquires Orphan Medical
    2007 : Divisional application filed by Jazz
    2008 : Security agreement to LB I Group
    2010 : Patent issues to Jazz Pharmaceuticals
         : Orphan Medical merger recorded
         : Reorg assignment to Jazz Pharmaceuticals
         : Security agreement to Silicon Valley Bank
    2011 : SVB release and reassignment
         : Xyrem ANDA litigation under way
    2012 : Security interest to Barclays Bank
    2013 : Jazz sues Amneal and Par
    2015 : Security agreement to Bank of America
         : Barclays release
    2021 : Bank of America release

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
The patent never moves to a licensing-only LLC. Every assignee is either the operating parent (Jazz Pharmaceuticals, Inc.) or a wholly owned operating subsidiary confirmed as such in Jazz Pharmaceuticals plc's SEC Exhibit 21 — "Subsidiaries of Jazz Pharmaceuticals Public Limited Company," which lists Orphan Medical, LLC (Delaware) and JPI Commercial, LLC (Delaware) as subsidiaries. JPI Commercial is not an anonymous Delaware shell: it is the entity that executed the License Agreement with Solvay Pharmaceuticals (2008–2009 amendments, per Jazz's 10-K exhibit list) — i.e., a commercial operator. No registered-agent-service address, no single-purpose asserting vehicle.

2. Known asserter in the chain — NOT PRESENT.
The current and historical owner is Jazz Pharmaceuticals (operating specialty pharma). Jazz does not appear on the RPX / Unified Patents high-frequency-plaintiff NPE lists, nor among Acacia, Marathon, IV, Wi-LAN/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, etc. Jazz is a plaintiff, but in its own name against generic ANDA filers (Hatch-Waxman), which is the operating-company posture, not the NPE posture. (Unified Patents' patent page for the sibling US 10,758,488 simply lists assignee "Jazz Pharmaceuticals Inc.")

3. Repeat correspondent across the chain — UNKNOWN / NOT RETRIEVABLE.
The correspondent of record is not exposed in the Google Patents legal-events feed and could not be pulled from Assignment Center in this analysis, so no recurrence finding can be made. Partial data point (family-level, not '506-specific): in IPR2016-00370 (sibling patent '431), Jazz's Statement Under 37 CFR 3.73(b) cited the inventors' assignment as recorded at Reel 025604, Frame 0903. That is the sole reel/frame recovered and it belongs to a family member, not to the '506 record itself. I flag this as a genuine evidentiary gap rather than asserting a finding.

4. Cascading transfers — PRESENT, but benign (internal reorg).
Five recordings cluster in a ~6-week window: 2010-11-12 (×2), 2010-11-17, 2010-11-26 (×2), 2010-12-22 — a Merger series plus chained assignments ending at Jazz Pharmaceuticals, Inc. Under the signal's own test ("especially when assignees share … common principals"), common principals are indeed shared — but they are all Jazz subsidiaries per SEC Exhibit 21, and the driver is the Orphan Medical → Jazz corporate conversion, not an NPE cascade. This is the classic internal-reorg signature, not a shell-chain.

5. Pre-litigation transfer — NOT PRESENT.
The last ownership assignment (JPI Commercial → Jazz Pharmaceuticals, Inc.) was recorded 2010-12-22, ~8 days after issue (2010-12-14) — housekeeping. The earliest cases naming this family run in the D.N.J. 2:10-cv-06108 / 2:11-cv-00660 window, with the '506 expressly asserted in the 2013 consolidated actions (2:13-cv-00391, 2:13-cv-05450, 2:13-cv-07884). There is no transfer within 6 months of a first suit that was arranged to enable assertion; the patent was already with the operating parent when suit was filed.

6. Bankruptcy fire-sale — NOT PRESENT.
No Chapter 7/11 anywhere in the chain. (Distinguish: Orphan Medical had a 2007 criminal/plea matter with the U.S. Attorney for the EDNY per Jazz's exhibit list — that is a compliance matter, not a bankruptcy or portfolio sale.)

7. Privateering — NOT PRESENT.
No transfer of the '506 to any third-party NPE asserting on Jazz's behalf. Jazz litigates in its own name (Jazz Pharmaceuticals, Inc. / Jazz Pharmaceuticals Ireland Limited) against competitors.

8. Defensive aggregator — NOT PRESENT.
The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates in the Jazz group, which is monetizing it offensively through product exclusivity and Hatch-Waxman suits.

Verdict

Operating-company assertion.

The chain never leaves the Jazz/Orphan corporate group: it runs Orphan Medical, Inc. → Orphan Medical, LLC (merger, 2010-11-12/26) → JPI Commercial, LLC → Jazz Pharmaceuticals, Inc. (2010-11-17 and 2010-12-22), all confirmed affiliated subsidiaries in Jazz Pharmaceuticals plc's SEC Exhibit 21, and all remaining recordings are bank security interests and releases (LB I 2008, Silicon Valley Bank 2010–2011, Barclays 2012–2015, Bank of America 2015–2021). No shell entity, no known NPE, no fire-sale, no defensive aggregator. The owner ships Xyrem® (NDA 21-196), a product embodying the claims, and asserts the '506 in its own name against actual generic competitors (Roxane/Hikma, Amneal, Par, Watson, Wockhardt, et al.) in the D.N.J. Hatch-Waxman actions — the textbook operating-company-assertion profile rather than an NPE pattern.

Two honest caveats: (i) reel/frame numbers for the '506-specific recordings were not retrievable in this session — the timeline rests on the Google Patents legal-events record, which is assignment-derived but reel/frame-poor; and (ii) correspondent-of-record data was unavailable, so Signal 3 (repeat correspondent) is unevaluated. If you need the definitive reel/frame and correspondent fields, the records must be pulled directly from https://assignmentcenter.uspto.gov/ (or a bulk assignment dataset) by patent number 7851506 — which is the one verification step I could not complete here.

I'll research US patent 7851506 and its prior art citations. Let me run several searches.

Let me get the specific cited references and the claims of US7851506.

Prior‑Art Analysis — US 7,851,506 B2

0. Scope, method, and caveats (read first)

• Sources used: Google Patents (patents.google.com/patent/US7851506B2), PubChem patent record (pubchem.ncbi.nlm.nih.gov/patent/US-7851506-B2), and USPTO PTAB/IPR petition exhibits (ptacts.uspto.gov). Full text of the patent was supplied directly; the front‑page citation list came from the PubChem/Google Patents records.
• Strict‑rule compliance: All patent numbers below are reproduced literally as they appear in the citation records. Where a reference is a family member rather than true prior art, I say so explicitly and do not renumber it.
• Honest limitation: I was able to confirm the citation list and the bibliographic data, but I could not retrieve the full issued claim set of US 7,851,506 in this session. The claim numbers I reference (1, 2, 3, 4, 5, 6, 62, 63, 64…) come from family prosecution documents for the parent/related patents (US 6,472,431; US 7,262,219; US 8,263,650) and from the PTAB record. Treat the claim‑mapping below as preliminary until verified against the printed claims of the '506 patent itself.
• Not legal advice / not a validity opinion. The § 102 mappings below are the potential anticipatory readings; whether a reference is § 102(a), (b), or (e) art depends on the reference's actual publication or filing date relative to the Dec 23, 1998 priority date.

1. Patent identity and bibliographic data

Because the effective filing date reaches back to Dec. 23, 1998, the critical date for § 102(b) art is Dec. 23, 1997, and for § 102(a) art the window is Dec. 23, 1997 – Dec. 23, 1998.

2. The citation list for US 7,851,506 (as recorded by PubChem/Google Patents)

The record lists the following "Citations." I have split them into true prior art, family members (not prior art), and uncertain items.

Patent‑document citations recorded:

1. GB‑922029‑A
2. JP‑S5742651‑A
3. US‑4393236‑A
4. EP‑0235408‑A1
5. US‑4738985‑A
6. EP‑0344704‑A1
7. US‑4983632‑A
8. JP‑H0449212‑A
9. JP‑H05508422‑A
10. EP‑0616804‑A1
11. US‑5380937‑A
12. EP‑0635265‑A1
13. WO‑9640105‑A1
14. US‑5594030‑A
15. US‑5753708‑A
16. US‑5840331‑A
17. US‑5990162‑A
18. EP‑1140061‑A2
19. US‑6436998‑B1
20. US‑6472431‑B2 ← family member (parent of '506)
21. US‑7262219‑B2 ← family member (parent of '506)

Additionally, the specification itself cites U.S. 4,393,236, British Patent No. 922,029, and U.S. 5,380,937.

3. Reference‑by‑reference analysis

A. The primary anticipatory references

1. US 4,983,632 A — Gessa et al. ("the '632 patent")

• Citation: US 4,983,632; commonly referenced as "Gessa et al. '632."
• Date: Patented 1991 (filed 1989); § 102(b) art (well before Dec 23, 1997).
• Description: Discloses use of gamma‑hydroxybutyric acid salts for preparing pharmaceutical compositions; states suitable salts include the sodium, potassium, calcium, or magnesium salt; GHB salt content can vary 12.5–50% by weight; discloses an aqueous bottle containing 6.05 g sodium GHB in 20 mL (≈302.5 mg/mL) and a 20 mL solution; also teaches an injectable formulation of sodium GHB free of preservatives; Example 5 discloses a 740 mg/mL sodium‑GHB aqueous gel.
• Potential § 102 anticipation: This is the strongest single reference. It anticipates family claims drawn to:
  • "an aqueous solution of a gamma‑hydroxybutyrate salt at a concentration of at least about 310 mg/mL, pH about 6 to about 10, chemically stable and resistant to microbial growth" — via the 740 mg/mL Example 5 gel (concentration met; the pH of aqueous sodium GHB is taught elsewhere as slightly above 7).
  • Claims reciting a preservative‑free aqueous sodium‑GHB solution (injectable example).
  • Claims reciting pH adjusting agents generally.
  • Claims reciting a gel dosage form.
  • Note: the 302.5 mg/mL example sits just below "at least about 310 mg/mL," so if the '506 claims use 310 mg/mL as the lower bound, the anticipation argument must rest on Example 5 (740 mg/mL).

2. US 5,840,331 A — Van Cauter et al. ("the '331 patent")

• Citation: US 5,840,331.
• Date: Patented Nov. 24, 1998; filed well before priority — § 102(b)/102(a) art.
• Description: Discloses GHB pharmaceutical compositions; states "acceptable carriers include aqueous solutions, non‑toxic excipients, including salts, preservatives, buffers"; "preservatives include antimicrobial agents, anti‑oxidants and chelating agents"; and "the pH and exact concentration of the various components [of] the pharmaceutical composition are adjusted according to well known parameters."
• Potential § 102 anticipation: Combined with Gessa '632 in the examiner's rejection of the parent 09/470,570 claims. Individually it is more a § 103 reference, but it expressly discloses the concepts that the '506 recites as inventive: aqueous GHB + preservative/antimicrobial + pH adjustment. If a '506 claim recites "a pH adjusting agent" or "preservative" without more, '331 is arguably anticipatory of that element (though a § 103 combination with '632 is the cleaner ground).

3. US 5,990,162 A — Scharf ("the '162 patent")

• Citation: US 5,990,162; assignee Orphan Medical, Inc. (same corporate family as the applicant).
• Date: Filed Aug. 29, 1997; issued Nov. 23, 1999 — i.e., after the Dec. 23, 1998 priority date. This is § 102(e) art (US patent granted on an application filed before the applicant's invention), not § 102(b).
• Description: Method for treatment of fibromyalgia and chronic fatigue syndrome; teaches GHB is effective in treating sleeping disorders and dosing (e.g., 3 g in 2 oz water ≈ 50 mg/mL administered).
• Potential § 102 anticipation: Anticipates family method‑of‑treatment claims — e.g., "a method of treating a sleep disorder/narcolepsy comprising administering GHB," and any claim reciting an administered (diluted) concentration of about 50–150 mg/mL. (The PTAB petition expressly relied on Scharf for the 50 mg/mL diluted dose.)

B. The GHB solution/salt references

4. US 4,393,236 A — Klosa

• Citation: "Production of nonhygroscopic salts of 4‑hydroxybutyric acid," US 4,393,236; issued July 12, 1983; § 102(b) art.
• Description: Produces non‑hygroscopic (magnesium/calcium) salts of 4‑hydroxybutyric acid; cited in the '506 specification as disclosing GHB's use as a pain reliever (analgesic). Also cited by Wikipedia as a standard GHB salt reference.
• Potential § 102 anticipation: Anticipates claims directed to GHB salts per se and to magnesium/calcium salts in the composition, and anticipates any claim to a method of treating pain using GHB.

5. EP 0 616 804 A1 ("EP '804")

• Date: Published Sept. 28, 1994; § 102(b) art.
• Description: Discloses administration of salts of GHB in the form of single‑ or multi‑dose liquid solutions, with the sodium salt particularly preferred; discloses a formulation for intravenous injection that is free of preservatives.
• Potential § 102 anticipation: Anticipates claims to an aqueous liquid GHB salt solution and to a preservative‑free GHB solution. Directly overlaps the core composition claims.

6. US 5,380,937 A ("the '937 patent")

• Date: Issued Jan. 10, 1995; § 102(b) art.
• Description: GHB used in closed cranio‑cerebral trauma and as a soporific; discloses GHB is commercially available as the sodium salt and that all experimental/clinical work used the sodium salt, the free acid, or the lactone; relates to organic salts and amides of GHB to reduce side effects.
• Potential § 102 anticipation: Anticipates claims reciting sodium GHB (sodium oxybate) as the active salt and method‑of‑treatment claims for CNS indications.

7. GB 922,029 A (British Patent No. 922,029)

• Date: Published March 1963; § 102(b) art.
• Description: Magnesium and calcium salts of 4‑hydroxybutyric acid produced to reduce the hygroscopic nature of GHB/powdered forms (cited both on the front page and in the '506 specification).
• Potential § 102 anticipation: Anticipates claims to magnesium/calcium salts of GHB (element‑level anticipation only; it does not disclose the aqueous, concentration‑limited, microbially‑resistant formulations that are the core of the '506 claims).

C. GHB dosing / delivery / derivative references

8. EP 0 635 265 A1

• Date: Published Jan. 25, 1995; applicant Laboratorio Farmaceutico CT SRL; § 102(b) art.
• Description: "Controlled release pharmaceutical compositions based on one or more pharmaceutically acceptable salts of gamma hydroxy‑butyric acid."
• Potential § 102 anticipation: Anticipates claims drawn to GHB salt compositions and to controlled/sustained‑release GHB dosage forms (if present in '506).

9. WO 96/40105 A1

• Date: Published Dec. 19, 1996; applicant Arch Development Corp.; § 102(b) art.
• Description: "Use of gamma‑hydroxybutyrate for the stimulation of sleep‑related growth hormone secretion."
• Potential § 102 anticipation: Anticipates method claims directed to increasing growth hormone levels by administering GHB (one of the "therapeutic categories" recited in the '506 specification/claims).

10. US 5,753,708 A — Koehler et al.

• Date: Issued May 19, 1998; § 102(a)/(b) art.
• Description: "Derivatives of 4‑hydroxybutyric acid."
• Potential § 102 anticipation: Anticipates claims to GHB derivatives/conjugates; marginal for the core aqueous‑solution claims.

11. US 5,594,030 A

• Date: Issued ~Jan. 14, 1997; § 102(b) art.
• Description: I could not confirm the subject matter with high confidence from the retrieved snippets (the record associates it with the GHB family, but the abstract was not retrieved).
• Note: Flag as unverified. Do not rely on this reference without pulling its face page.

12. US 6,436,998 B1

• Date: Issued ~Aug. 20, 2002 (filed 1998–2000 range).
• Description: Title/abstract not confirmed in this session; associated with GHB‑related organic‑salt/composition art.
• Note: Flag as unverified. Likely § 102(e) art if its filing predates Dec. 23, 1998.

13. US 4,738,985 A / EP 0 235 408 A1 / EP 0 344 704 A1 / EP 1 140 061 A2 / JP S57‑42651 A / JP H04‑49212 A / JP H05‑508422 A

• Dates (approx.): 4,738,985 (1988); EP 0 235 408 (Sept. 1987); EP 0 344 704 (Dec. 1989); EP 1 140 061 (Oct. 2001); JP S57‑42651 (1982); JP H04‑49212 (1992); JP H05‑508422 (1993).
• Description: I could not verify the subject matter of these references from the retrieved material. They appear in the citation record as supplementary art.
• Note: Flag all as unverified. EP 1 140 061 (Oct. 2001) and other post‑1998 publications cannot be § 102 prior art against the Dec. 23, 1998 priority date unless they have an earlier effective US filing (potential § 102(e)).

D. Documents that are not prior art

14. US 6,472,431 B2 and 15. US 7,262,219 B2

• These are the parent patents of US 7,851,506 (same inventors, same assignee, same disclosure). They appear in the citation record only because the '506 specification's RELATED APPLICATIONS section cites them. They are common‑ownership family members, not prior art, and cannot be § 102 references against the '506 patent.

4. Bottom‑line ranking for § 102 purposes

The most relevant single piece of prior art for US 7,851,506 is US 4,983,632 (Gessa et al.), because its Example 5 (740 mg/mL sodium GHB in aqueous medium) and its preservative‑free injectable example read directly onto the concentration/pH/stability composition claims that the family pursued. The examiner's parent‑application rejection (09/470,570) expressly combined Gessa '632 + Van Cauter '331, with Scharf '162 supplying the method‑of‑treatment teachings.

5. Non‑patent literature cited (for completeness)

The record also cites extensive NPL, much of which asserted antecedence of the therapeutic use rather than of the formulation: Arena & Fung (1980); Bedard (1989); Broughton (1979); Carter Snead (1981); Ferrara (1992); Gallimberti (1989, 1992, 1993, 1994); Gerra (1994); Gessa (1992, 1993); Grove‑White & Kelman (1971); Hasenbos & Gielen (1985); Lammers (1993); Mamelak (1977, 1979); Palatini (1993); Scharf (1985); Scrima (1990); Series (1992); Strong (1984); Yamada (1967); plus Remington's Pharmaceutical Sciences (8th/15th eds.), Nema et al. (1997), Handbook of Pharmaceutical Excipients (2nd ed., 1994), 21 C.F.R. 184, and the 1995 USP. These are primarily § 103/general‑knowledge references (e.g., Nema for preservatives/buffers; Handbook of Pharmaceutical Excipients for malic acid), not standalone § 102 anticipators of the formulation claims.

Would you like me to:

1. Pull the actual printed claim set of US 7,851,506 (columns of the PDF) so the § 102 claim mapping can be made exact, and/or
2. Retrieve the front‑page "References Cited" dates/titles directly from USPTO PatentCenter for the unverified JP/EP/US items flagged above?

Either would let me tighten the "which claim is anticipated by which reference" determinations, which are currently preliminary.

I'll start by pulling the operative claim language and the prior-art references of record, since the provided full text is truncated before the claims.

Let me retrieve the exact claim set and the references-cited list for the '506 patent.

Preliminary note on sources and evidentiary limits

Two things must be flagged before the analysis, per the operating rules:

1. The page text you supplied is truncated. It ends mid-sentence in the description ("Of course, it is under…") and contains no claims, no "References Cited" list, and no explicit prior-art section. Google Patents shows only the "prior art keywords" (ghb, formulations, day, formulation, dose) and the background citations embedded in the specification. I therefore reconstructed the operative claim language and the prior art of record from the family's prosecution history and the parallel litigations, and I have cited those sources by URL.
2. I did not auto-correct any identifier. "US7851506B2," "US6472431B2," "US4983632," "CA 338," "EP 344704" are reproduced exactly as they appear in the documents retrieved.

I. What the claims actually cover

The '506 patent is a divisional of Ser. No. 10/841,709 (which issued as US 7,262,219), which is a divisional of Ser. No. 10/194,021 (US 6,780,889), which is a divisional of Ser. No. 09/470,570 (US 6,472,431, "the '431 patent"), claiming priority from provisional 60/113,745 filed December 23, 1998. (Google Patents) The '506 specification is therefore materially the same disclosure as the '431/'889/'219 patents. The patent issued with 26 claims (RPX litigation document, front page).

Claim 1 is a method-of-treatment claim, not a composition claim. As quoted in the prosecution record and the IPR petition filings, it reads substantially:

"A method of treating a condition responsive to sodium gammahydroxybutyrate, comprising orally administering to a patient afflicted with the condition an aqueous composition comprising a first dose of about 4.5 to about 10 grams of sodium gammahydroxybutyrate within an hour prior to initial sleep onset and an aqueous composition comprising a second dose of about 4.5 to about 10 grams within 2 to 5 hours following initial sleep onset, wherein the aqueous composition of the first dose and the aqueous composition of the second dose each comprises a respective concentration of sodium gammahydroxybutyrate of greater than about 500 mg/mL, wherein the condition is selected from the group consisting of apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus."

(PTAB petition record quoting the Jan. 11, 2010 Amendment and July 28, 2010 Amendment)

Critically for §103:

• Claim 1 does not recite a pH value, a pH-adjusting agent, malic acid, or "free of preservatives." Those limitations live in the sibling patents ('431, '219, '650, '275, '889) and in dependent claims here, not in '506 claim 1.
• The claimed elements reduce to four: (i) oral administration; (ii) a divided twice-nightly dosing schedule (bedtime + 2–5 h later); (iii) 4.5–10 g per dose of NaGHB; (iv) a concentration >500 mg/mL in each dose; for a genus of conditions (narcolepsy/cataplexy etc.).
• "Chemically stable" and "resistant to microbial growth" are not recited in '506 claim 1; they appear in the specification as the result the concentration/pH selection produces (the '431 patent defined "resistant to microbial growth" by FDA/USP preservative-effectiveness criteria — PTAB record quoting '431 at 3:25-31).

This is decisive for the analysis: for §103 purposes, the claims are directed to a known drug, in a known type of formulation, administered on a known schedule, at a concentration that is the upper end of a range the art already disclosed.

II. The prior art of record (the "prior art section" of this page)

The organic references cited in the '506 patent's "Description of Related Art," together with the references applied during prosecution of the '506 family, are:

The '506 specification itself supplies the problem statement that supplies the motivation to combine: GHB "degrades into gamma-butyrolactone (GBL)… in solution depending upon the pH and other factors," "contamination by microorganisms in GHB solutions rapidly surpass acceptable limits," "preservatives can adversely affect the pH and thus GHB's stability," and "the volume of a non-concentrated product creates cost and handling issues." (US7851506B2, Description)

III. Level of ordinary skill in the art

A POSITA here would be a formulation scientist or pharmaceutical chemist (Ph.D./M.S., or B.S. with several years' experience) in oral-liquid and parenteral dosage-form development, working with the knowledge captured in Remington's Pharmaceutical Sciences and Nema et al., 1997 (both cited in the '506 specification and in the prior art of record), or a sleep-medicine clinician familiar with the GHB narcolepsy literature (Scharf, Mamelak, Scrima, Broughton). Both ordinary-skilled profiles are documented in the references themselves.

IV. Combinations that render the claims obvious

Combination A — Gessa '632 + CA 338 (+ Van Cauter '331 / '083), alone or with routine optimization

Target: any composition-type or "rendering" claims in the family, and the concentration element of '506 claim 1.

• Gessa discloses aqueous NaGHB compositions spanning 12.5–50% by weight — i.e., up to roughly 500–600 mg/mL — including a 20 mL/6.05 g injection (302.5 mg/mL), and expressly a preservative-free injectable.
• CA 338 supplies the neutral-range pH (7.2–7.7) for an injectable GHB salt solution.
• Motivation: both references are in the identical field (aqueous GHB salt solutions for human administration). A POSA seeking a GHB liquid for chronic nightly dosing would (a) select the highest concentration that remains a solution, to reduce the swallowed volume (Gessa's own 50% w/w upper limit), and (b) adjust to physiological/neutral pH with an acid (Vickers' marketed product is at pH 8.2–8.9; Nema supplies a menu of GRAS acids).
• KSR rationales engaged: design incentive (volume reduction for a chronically self-administered drug), predictable variation (concentration and pH are recognized result-effective variables in liquid formulation), known technique (acid titration of an alkaline NaGHB solution).

Combination B — Broughton et al. 1979 + EP 344704 / Gessa (the examiner's own rejection)

Target: the method-of-treatment genus.

This is the combination the Examiner actually applied during prosecution (rejections of claims 1 and 2 over "Broughton et al.… in view of Gessa et al., EPO 344704"), and it is the cleanest §103 attack because it uses only references of record in the file. Broughton discloses oral GHB solutions of 150–225 mg/mL used to treat narcolepsy; EP '804 discloses administration of GHB salts in single- or multi-dose liquid form. Motivation: EP '804 supplies the multi-dose liquid administration format; Broughton supplies the narcolepsy indication and the oral solution; Gessa supplies the salt and concentration envelope. The applicant's rebuttal — that Broughton's 150–225 mg/mL solutions were more dilute than the claimed >500 mg/mL and that the prior art "taught away" — is a range/teaching-away argument, addressed in §V below.

Combination C — Scharf 1985 (or Mamelak 1986) + Gessa '632 + Scrima 1990

Target: '506 claim 1 specifically (the method-of-treating claim). This is the combination advanced in the IPR petition directed at the '506 patent, and it maps onto every element:

• Motivation to combine: All three references address the same problem — how to give an effective nightly GHB dose to narcoleptics. A POSA reading Mamelak's report that patients need 4.5–9 g/night and Scrima's express statement that higher doses may be required, would have been motivated to escalate from Scharf's 3 g × 2 to 4.5 g × 2; and, to keep the swallowed volume tolerable for a nightly, chronic, self-administered product, would have used the most concentrated solution the art disclosed (Gessa's 50% w/w; Scrima's 740 mg/mL form).
• KSR rationales: "obvious to try" a known parameter (dose) in a known direction (up) with a predictable benefit; obvious optimization of a result-effective variable (In re Aller, In re Boesch); dose-response obviousness (In re Kao).

Combination D — Vickers + Nema et al. + Mamelak + Gessa '632

Target: concentration/pH/preservative-free limitations of dependent claims.
Vickers teaches NaGHB is "water soluble in all dilutions" and that a marketed product is already a 242 mg/mL aqueous injectable at pH 8.2–8.9; Nema teaches pH-adjusting agents and, importantly, that preservatives may be disallowed in parenterals, with GRAS organic acids as pH adjusters; Mamelak and Gessa supply the narcolepsy regimen and the salt. Motivation: providing a preservative-free liquid GHB product is directly suggested by Nema (route-of-administration restrictions) and by Gessa's own preservative-free injectable, while the need for preservative-free formulations is stated in the '506 specification (instability of the XYREM™ preservative, xylitol/GHB solid-state incompatibility). This combination is strongest against the sibling '650 patent's "about 500 mg/mL, pH 7.3–8.5, preservative-free" claim, but it also bears on any '506 dependent claim reciting concentration.

Combination E (secondary) — '236 patent + GB 922,029 + '937 patent

Target: any claim reciting alternative/ammonium/calcium/magnesium GHB salts, and the "one or more salts" language. The '506 specification itself recites these salts as known, citing U.S. 4,393,236 (Mg/Ca salts to reduce hygroscopicity) and British Patent 922,029. Since the specification admits these salts are known, a §103 attack on salt-selection claims rests on routine substitution of a known equivalent (function of the GHB anion, not the counterion).

V. Why a POSITA would combine — consolidated motivation

1. Same field, same problem. Every reference is a GHB formulation or a GHB narcolepsy-therapy report. The '506 specification identifies the pre-existing problems as GBL formation, microbial contamination, preservative-driven pH instability, and high volume for a chronically used drug. That is the classic "known problem → known solution" fact pattern.
2. The prior art already recognized that concentration and pH jointly control both microbial resistance and GBL formation. Wickliffe teaches that bacterial growth is inhibited at extreme pH without added preservative; Gessa's concentration envelope runs to ~50% w/w; CA 338 and Vickers give the neutral/physiological pH targets. A POSA would therefore have expected the claimed concentration/pH selection to produce a self-preserving, chemically stable liquid as a matter of predictable physical chemistry — and the specification itself frames the result as observed, not invented ("GHB at this concentration in an aqueous medium that is between about pH 5 and pH 9 is resistant to microbial growth").
3. Reasonable expectation of success. All claim elements are individually disclosed: the drug (Gessa, Vickers, Scharf), the aqueous vehicle (Gessa, Vickers, Broughton), the twice-nightly schedule (Scharf, Mamelak), the dose band (Mamelak, Scrima), the concentration (Gessa 12.5–50% w/w; Scrima 740 mg/mL jelly), and the pH-adjustment techniques (Nema, '083, CA 338). Combining predesignated, individually known elements with predictable interactions is the core of KSR Int'l v. Teleflex.
4. Design incentives. Shipping/storage volume reduction and patient portability (recited in the '506 specification as a benefit) are independent, market-driven reasons to select the highest practical concentration.
5. Inherency. Even if not "recognized" pre-1998, the chemical stability and microbial resistance of a given concentration/pH combination are inherent properties of an otherwise obvious formulation (Schering Corp. v. Geneva Pharms., 339 F.3d 1373 (Fed. Cir. 2003); Toro Co. v. Deere & Co., 355 F.3d 1313, 1320 (Fed. Cir. 2004)). This directly defeats the applicant's "self-sterilization is unexpected" argument on the composition aspects.

VI. The applicant's counterarguments — and their weakness

The prosecution history shows the applicant won allowance on exactly these points, so any §103 analysis must engage them:

• "Unexpected self-sterilization." The applicant argued that the ability of aqueous GHB solutions to "self-sterilize" at the claimed concentrations and pH is an unexpected result rebutting prima facie obviousness. (PTAB record quoting Feb. 21, 2007 Amendment) Counter: the "unexpected" property is a law-of-nature–type observation of an inherent property of the concentration/pH combination (high solute load → low water activity; pH outside microbial optima), and it was not tied to any structural change in the composition. Also note the specification's own acknowledgement that preservative-free is a goal (Nema taught preservative exclusion for parenterals; Gessa disclosed a preservative-free injection).
• "Prior art taught away" because Broughton disclosed only 150–225 mg/mL and Gessa only 302.5 mg/mL. Counter: a disclosure of lower concentrations is not a teaching away absent a statement that higher concentrations are inoperative. The '506 specification itself asserts GHB is soluble to ~750 mg/mL at room temperature and ~1000 mg/mL on heating, so higher concentrations were known to be operable; Scrima's 740 mg/mL form and Gessa's 50% w/w upper bound reinforce this.
• "Criticality of the 500 mg/mL figure." The 500 mg/mL value was added during prosecution to overcome Scrima's ~740 mg/mL jelly disclosure (PTAB record). A POSA evaluating criticality would ask whether 500 mg/mL vs. 740 mg/mL vs. 600 mg/mL produces a difference in kind or merely in degree; the specification discloses smooth trends (FIG. 1), which cuts against criticality.
• "Production problems" / preservative incompatibility. These support the commercial value of the invention but are not themselves claim limitations of '506 claim 1 and do not rebut a prima facie case built on the treatment regimen and concentration.

Strength of the family's defense: the strongest non-obviousness story is a secondary-considerations package — long-felt need for a preservative-free, high-concentration, self-preserving GHB product, failure of others (the abandoned XYREM™ xylitol/preservative formulation, the foil-pouch workaround), and the commercial success of the eventual 500 mg/mL malic-acid–neutralized product. Whether that package suffices is a question of nexus (the commercial product is at 500 mg/mL, not >500 mg/mL, which may undercut nexus to the '506 concentration limitation — the very point Par advanced in the litigation, noting the product label instructs dilution (PTAB record)).

VII. Bottom line

• Under a straightforward (KSR-era) §103 analysis, '506 claim 1 is, in my assessment, vulnerable to an obviousness challenge, chiefly on Scharf 1985 + Mamelak 1986 + Scrima 1990 + Gessa '632 (a.k.a. "the '632 patent"), with CA 338 / Vickers / Nema supplying the formulation and pH techniques, and Broughton 1979 + EP 344704 supplying the multi-dose liquid-administration format the Examiner already relied on. Each limitation is disclosed in the prior art; the combination is directed to the same problem; and the only genuinely arguable gap is the 4.5 g/dose floor and the >500 mg/mL floor, both of which fall inside prior-art ranges (Mamelak's 4.5–9 g/night; Gessa's 12.5–50% w/w; Scrima's ~740 mg/mL form) and are therefore "obvious to try" / routine optimization.
• The strongest non-obviousness position for the patentee is (i) a nexus-bearing, unexpected-results and long-felt-need showing specifically tied to the preservative-free, self-preserving character of the formulation, and (ii) the argument that "resistant to microbial growth" is a claim-construed term tied to USP/FDA criteria that the prior art never measured or attributed to concentration alone. Notably, the applicant succeeded at the USPTO on essentially argument (i) during the parent ('431) prosecution.
• Caveat: Because the page you supplied omits the issued claims, my claim-1 reconstruction rests on the prosecution amendments and IPR pleadings quoted in the documents above. Before relying on this analysis, the issued claim set of US7851506 should be verified against the granted patent (26 claims per the RPX front page), and the dependent claims mapped separately — several of them (concentration, dilution, pH) may be more or less vulnerable than claim 1.
• I did not verify the final merits outcome of the inter partes review petitions filed against this family (e.g., the petition papers at ptacts.uspto.gov referenced above). The documents retrieved describe the grounds and the prior art; they do not establish the Board's or the court's ultimate §103 holding, and I have not assumed one.