US 7262219

I'll search for current information on this specific patent number, then cross-reference with the authoritative patent text provided.

Let me verify the claim text and check for any 2026 Federal Circuit activity specific to this patent.

Let me pull the remaining claims (claim 4) and confirm the expiration/litigation status.

Summary — US Patent 7,262,219 ("the '219 patent")

Caution on the ID: I searched for the literal string 7262219 / 7,262,219. Note that several search hits referring to "the '221 patent" (e.g., CourtListener briefs about media content storage) are a different patent — those discuss an unrelated software patent and must not be conflated with US 7,262,219.

Bibliographic data (grounded in the Google Patents record and USPTO-family documents)

Abstract

"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."

Plain-language overview of the claims

The '219 patent issued with 4 claims (per the Par/Amneal IPR petition record: "On August 28, 2007, the '219 patent issued with 4 claims"). Independent claim 1 is a preservative-free composition claim:

Claim 1 (independent – pharmaceutical composition):

"A pharmaceutical composition, consisting essentially of an aqueous solution of about 350–750 mg/ml sodium gamma-hydroxybutyrate, and a pH adjusting agent, wherein the pH adjusting agent is malic acid, citric acid, acetic acid, lactic acid, carbonic acid, formic acid, propionic acid or tartaric acid, wherein the composition has a pH of about 6–7.5, and wherein the composition is chemically stable and resistant to microbial growth, and wherein the composition is free of preservatives."

Plain language: A concentrated liquid GHB (sodium oxybate) product — 350–750 mg/mL in water — whose pH is brought to roughly 6–7.5 using one of eight named organic acids (malic acid being the commercial example), and which achieves chemical stability and microbial resistance without any added preservative.

Claim 2 (dependent on 1): Narrows the concentration to about 400–650 mg/ml.
Claim 3 (dependent on 1): Narrows the pH-adjusting agent to malic acid.

Claim 4 (independent): Litigation filings (Par's IPR petition) establish that claim 4 is also a "free of preservatives" claim — Par argued its sodium-benzoate-containing product does not infringe "claims 1 or 4" because of that limitation. I do not have the verbatim text of claim 4 from an authoritative source and will not reconstruct it; treat its precise wording as unverified. (One third-party aggregator, drugpatentwatch.com, shows only a truncated "4." entry.)

Relationship to the claim sets sometimes attributed to this family

Beware of confusion with sibling patents: US 6,472,431 (the '431 patent) claims methods ("A method of rendering an aqueous medium resistant to microbial growth, comprising adding the gamma-hydroxybutyrate salt … to a final concentration of at least about 250 mg/ml …"), and some third-party inventories that list the '219 number actually reproduce the '431-style method claims. The '219 patent itself is a composition patent.

Litigation / docket information retrieved

• Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc., No. 10-6108 (D.N.J.) — asserted the '219 patent (along with 6,780,889; 7,668,730; 7,765,106; 7,765,107). Claim construction order issued Sept 14, 2012. The court construed "preservative" as a substance "added in addition to the gamma-hydroxybutyrate salt to inhibit chemical change or microbial action."
• IPR/PTAB petition 1459711 (Par) challenged claims 1–4, arguing inter alia that the claimed pH-adjusting agent is itself a "preservative" under the Roxane construction, creating a §112 indefiniteness/enablement problem and an evidentiary estoppel issue from the '431 prosecution history.
• Numerous ANDA suits in D.N.J. (2012–2017, e.g., 2:13-cv-05450, 2:14-cv-07757, 2:15-cv-06548, 2:17-cv-05487) and 2:17-cv-04439 (E.D.N.Y.) per Unified Patents' litigation data.
• Jazz's Orange Book listing for NDA 021196 (XYREM, sodium oxybate oral solution) formerly listed 7,262,219.

Federal Circuit / 2026 docket check: I found no Federal Circuit or 2026 appeal specifically involving US 7,262,219. The prominent 2025 Jazz/Avadel Federal Circuit decision (Nos. 2024‑2274/2277/2278, Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, decided May 6, 2025 — Hatch‑Waxman safe harbor, permanent‑injunction scope) concerns U.S. Pat. No. 11,147,782 and a set of later sodium‑oxybate patents (e.g., 10,966,931; 10,758,488; 10,959,956), not the '219 patent. Since the '219 patent expired around 2020–2021, its absence from current appellate dockets is expected.

Explicit uncertainties

1. Claim 4's verbatim language — not authoritatively retrieved.
2. Exact expiration date — sources differ (Jul 4, 2020 vs. Apr 5, 2021 "adjusted expiration," with a Jan 4, 2021 PED date). All agree the patent has expired.
3. Current 2026 status — no evidence of any live 2026 CAFC proceeding on this patent; the searches returned the Avadel/'782 matter, which is a different patent.

I'll research litigation involving US Patent 7262219. Let me run several searches.

Let me dig into the specific case dockets.

Litigation involving U.S. Patent No. 7,262,219 ("the '219 patent")

Patent background (for context)

• U.S. 7,262,219 B2, "Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy." Application No. 10/841,709, filed 2004-05-07 (a divisional of 10/194,021 → U.S. 6,780,889, itself a divisional of 09/470,570 → U.S. 6,472,431). Earliest priority 1998-12-23. Granted 2007-08-28. Original assignee Orphan Medical Inc.; current/listed assignees Jazz Pharmaceuticals Inc. / JPI Commercial LLC. Legal status shown as Expired – Lifetime (adjusted expiration 2021-04-05).
• The '219 patent is a member of the "'431 patent family" (sodium oxybate / GHB compositions, methods of making and using), which Jazz asserted as the "Product Patents" alongside the '431, '889 and '506 patents. It was listed in the Orange Book for Xyrem (NDA 021196) with a 07/04/2020 expiration.

Important caveat up front: most published databases (including the Google Patents "litigation" links on the '219 page, and drugpatentwatch) list family-level litigation — i.e., cases involving the Xyrem patent family — not every one of which necessarily asserted the '219 patent by number. Below I separate (A) cases where the '219 patent was expressly asserted/identified as a patent-in-suit or Paragraph IV patent, from (B) cases where '219 is cited in the pleadings/records.

A. Hatch-Waxman / ANDA patent-infringement actions in which the '219 patent was asserted

Also listed by Google Patents as "US case filed in New Jersey District Court" connected to the '219 family: 2:13-cv-05450; 2:14-cv-04467; 2:14-cv-07757; 2:13-cv-07884; 2:15-cv-06548; 2:15-cv-05619; 2:17-cv-05487; and a case in the Eastern District of New York, 2:17-cv-04439. Google Patents also records the "first worldwide family litigation" for Darts-IP family 22351244. These are reported at the patent-family level and I could not independently confirm the '219 patent itself was asserted in each.

B. Non-ANDA matters in which the '219 patent appears in the record

C. Key outcomes / overall picture

• The '219 patent was one of the original Xyrem "Product Patents" asserted by Jazz against Roxane in the lead action (2:10-cv-06108), which spawned nine consolidated New Jersey suits against Roxane and parallel suits against Amneal, Par, Ranbaxy, Watson, Wockhardt and Lupin.
• No case against the generics went to judgment on the '219 patent. All of the Hatch-Waxman actions against Roxane and the other ANDA filers were settled before trial (Roxane settled 2017-04-05; the Amneal/Par/Ranbaxy/Watson/Wockhardt/Lupin actions settled during 2016–2018). The settlements reportedly allocated U.S. sodium-oxybate market entry (branded Xyrem to 12/31/2022; authorized generic 1/1/2023; further generics 7/1/2023 and 12/31/2025) and are the basis of the follow-on antitrust complaints.
• The later Avadel dispute (Jazz v. Avadel, 1:21-cv-01594; Avadel v. Jazz, 1:22-cv-00487, D. Del.) is the most recent active litigation in which the '219 patent appears; I could not confirm a final judgment from the retrieved sources.
• The '219 patent itself is shown as expired (2021-04-05), so it is no longer enforceable.

D. Confidence and caveats

• High confidence: the Jazz v. Roxane (2:10-cv-06108) and Jazz v. Amneal (2:13-cv-00391) filings listing the '219 patent (both corroborated by Jazz SEC Form 8-K filings and court records); the resulting settlements; the Avadel and antitrust matters listing '219.
• Lower confidence / flagged: exact docket numbers and filing/termination dates that drugpatentwatch and Google Patents redacted or report only at family level (e.g., the 2016-01-27 Roxane '219 entry; the 2018-12-20 D. Del. 35:271 case terminated 2022-02-09; NJ dockets 2:13-cv-05450, 2:17-cv-05487, and E.D.N.Y. 2:17-cv-04439). I could not map each of those to the '219 patent specifically.
• Not verified: final dispositions/outcomes in the Avadel matters, and whether the '219 patent survived any invalidity challenge (the family's later patents, e.g., the '730 and '963 patents, were subject to IPR and were invalidated, but I found no PTAB proceeding on the '219 patent).

If you have PACER or Darts-IP access, the specific dockets to pull are: 2:10-cv-06108 (D.N.J.), 2:13-cv-00391 (D.N.J.), 1:21-cv-01594 and 1:22-cv-00487 (D. Del.), and the antitrust dockets 0:21-cv-00737 (D. Minn.), 3:20-cv-04056 (N.D. Cal.) and the N.D. Ill. Blue Cross matters.

I'll verify the ODP "no proceedings" default against public web sources before writing this up.

The ODP block says no proceedings, but search surfaced PTAB petition documents referencing the '219 patent. Let me pin down whether an IPR was actually filed against it.

Let me check whether any later IPR (2016–2020) was filed against the '219 patent, and confirm the '219's Orange Book/litigation history.

PTAB / AIA Trial Analysis — US 7,262,219 B2

"Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy"
Patent owner of record: Jazz Pharmaceuticals, Inc. / JPI Commercial, LLC (original assignee Orphan Medical, Inc.) · Priority: 1998-12-23 · Filed: 2004-05-07 · Granted: 2007-08-28 · Adjusted expiration on the face of the record: 2021-04-05

Proceedings overview

Zero AIA trial proceedings have ever been filed against US 7,262,219 — the USPTO Open Data Portal block for this patent returns no IPR, no PGR, and no CBM (0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denied), so the defensive posture a defendant should take is not "this patent has been hardened by surviving IPRs" and not "its claims are canceled," but rather: its claims 1–4 have never been tested at the PTAB at all — and the patent expired on 2021-04-05, which is the fact that actually decides the case in 2026.

Because there are no proceedings to list, the per-proceeding template below is deliberately not populated. I have instead (a) recorded the negative finding and its basis, and (b) catalogued the adjacent Jazz/sodium oxybate PTAB activity so that no one mistakes it for '219 activity — a real risk, because those petitions' exhibits discuss the '219 patent at length.

No proceedings to list

Basis for the negative finding. The structured "PTAB proceedings on file" block — the canonical ODP list for this patent — states: "The USPTO ODP API returns no AIA trial proceedings for this patent as of the most recent ingest." I could not locate any institution decision, final written decision, or petition caption in public sources naming U.S. Patent No. 7,262,219 as the challenged patent. Independent corroboration: drugpatentwatch's patent-specific page for 7,262,219 lists district-court litigation but no PTAB case row (drugpatentwatch, patent 7,262,219).

Structural reasons this is plausible, not an ingest gap:

• PGR was never available. The '219 has a 1998-12-23 priority date, far pre-dating the 2013-03-16 AIA transitional date. Post-grant review cannot reach it.
• CBM was never available. The claims are pharmaceutical-composition claims; the patent is not a "financial product or service" patent under AIA § 18. Covered business method review cannot reach it.
• That leaves IPR only — and Jazz's generic challengers spent their January 2015 IPR budget on the '730 family (REMS/distribution) patents, not the '431-family composition patents. The composition patents (the '431, '889, '219, '506, '650, '275) were fought in district court on non-infringement grounds — chiefly the "free of preservatives" limitation — rather than at the Board.

⚠️ Flag — a public artifact that looks like a '219 petition but is not one

Search results for "'219" + "IPR" surface a PTAB E2E public-information document bundle (ptacts.uspto.gov … petitions/1459711) whose contents include a detailed claim-by-claim obviousness attack on the '219 patent, e.g.:

"The claimed 'about' 350-750 mg/mL concentration is obvious over the prior art 302.5 mg/mL concentration in the '632 patent." … "[C]laim 1 of the 219 Patent … consisting essentially of an aqueous solution of about 350-750 mg/mL sodium gamma-hydroxybutyrate …"

This is not an IPR petition against the '219 patent. It is Par Pharmaceuticals' Hatch-Waxman "Detailed Statement of the Factual and Legal Bases … that U.S. Patent Nos. 6,780,889; 7,262,219; 7,668,730; … are invalid and/or not infringed," dated 2013-11-20 and signed by Par's SVP of Corporate Regulatory Affairs — i.e., a Paragraph IV opinion-of-counsel exhibit that wound up in the PTAB's public file as an exhibit in a proceeding directed at a different Jazz patent. Do not cite it as a Board ruling on the '219: it is an adversary's advocacy document, and it carries zero preclusive or estoppel effect on the '219.

Adjacent PTAB activity — sibling Xyrem patents (NOT this patent)

Listed only so you can distinguish it; none of these proceedings challenges US 7,262,219, and none of their outcomes cancel any '219 claim.

Petitioners: Par Pharmaceutical, Inc. and [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC), jointly. Institution granted 2015-07-28 for the six January petitions (Jazz 8-K, 2015-07-29, jazzpharma.gcs-web.com); the panel on the '730/'988 institution decisions was APJs Jacqueline Wright Bonilla, Susan L.C. Mitchell, and Brian P. Murphy (IPR2015-00554 institution decision, 2015-07-28). The art was FDA advisory-committee background materials on the Xyrem REMS, published June 2001 — more than a year before the '730 family's 2002-12-17 earliest effective date. Jazz appealed all seven; per Jazz's own antitrust complaint, the Federal Circuit affirmed in all instances. Caveat: the affirmance detail comes from an adverse party's pleading (In re Xyrem Antitrust Litig. complaint, 2020-07-31); I did not pull the individual Rule 36 judgments, so treat the specific appellate dispositions as party-attributed rather than verified.

Strategic summary

Claim status on 7,262,219: all UNTESTED; none canceled; none sustained. This patent issued with a small claim set — claims 1–4, in which claim 1 is the sole independent claim (a pharmaceutical composition "consisting essentially of an aqueous solution of about 350–750 mg/mL sodium gamma-hydroxybutyrate" plus a specified pH-adjusting agent, pH about 6–7.5, "chemically stable and resistant to microbial growth," and "free of preservatives"), with claims 2–4 depending from claim 1 (claim 4 adding further limitations). Those are the claims Jazz actually asserted against Roxane, Amneal, Par, Watson, Lupin and others; that identification comes from Par/Amneal's Paragraph IV statements and the '219 claim-construction briefing in D.N.J. — the authoritative full text supplied for this analysis truncates before the claims, so treat "claims 1–4" as well-supported but not independently re-verified from the patent copy. Because there is no FWD, there is no claim-level verdict to quote, and any representation that a '219 claim was canceled or confirmed is false.

Estoppel landscape: there is essentially none, and that cuts both ways. § 315(e)(2) estoppel attaches only to a petitioner that obtains an instituted IPR that reaches a final written decision. Amneal and Par obtained no FWD on the '219, so they are not estopped as to the '219 from raising any § 102 or § 103 ground they raised or reasonably could have raised — the full prior-art field remains open to them and to every other defendant in district court. Conversely, because nothing was litigated at the Board, Jazz gained no favorable validity findings either; there is no "hardened" record to attack. Practically: all invalidity theories remain on the table, subject only to district-court estoppel and the effect of any prior court rulings on the same issues.

Pattern signals. (1) No serial IPR campaign against this patent. The Amneal/Par multi-petition pattern exists, but it targeted the '730 family — seven petitions, one patent family, a common REMS prior-art theory — not the '431-family compositions. (2) No defensive aggregator appears in the chain for the '219. I found no Unified Patents (or comparable NPE-defense) petition here. Note that the Google Patents family record does link to Unified's litigation portal for the New Jersey docket entries, but that is docket metadata, not Unified-filed PTAB activity. (3) The patent owner litigated aggressively in Article III courts but never had to defend a Board trial on this patent; the '219 was the subject of a decade of ANDA suits (D.N.J. 2:10-cv-06108, 2:13-cv-00391, 2:14-cv-07757, 2:15-cv-05619, 2:17-cv-05487, and more) plus follow-on antitrust litigation. The absence of PTAB activity on a patent this heavily asserted is unusual and is best explained by its early expiry (2021) and by the generics' success on non-infringement rather than invalidity.

Recommended next steps

1. Lead with expiry, not invalidity. The '219's adjusted expiration is 2021-04-05. If a demand letter in 2026 cites claims 1–4, the threshold response is that the patent term has run: no prospective injunction, no ongoing royalty, and only a closed pre-2021-04-05 damages window — itself limited by the § 286 six-year lookback to conduct on or after roughly the date six years before any complaint is filed. Verify the expiry and any pediatric-exclusivity extension against the Orange Book entry for NDA 021196 before relying on it in a letter, because the litigation pleadings are internally inconsistent on this point (one complaint states the '219's six-month pediatric exclusivity expired 2021-01-04, while the patent-face adjusted expiration is 2021-04-05).
2. There is no FWD to link and no claim disposition to quote — say that explicitly in any client memo. The correct citations for the negative finding are: the ODP "PTAB proceedings on file" block for this patent (no AIA trials), the PTAB E2E portal search for the patent number, and drugpatentwatch's 7,262,219 page (litigation rows only, no PTAB rows).
3. If your defense is invalidity, build it fresh — do not assume estoppel helps you. No petitioner is estopped on the '219, which means you inherit no admissions and no record; you also inherit no helpful prior Board construction. The prior art Par/Amneal relied on in district court (notably U.S. Patent No. 4,983,632 to Gessa, and the '632 patent's 302.5 mg/mL Example 2) is a reasonable starting point, but it is advocacy, not a Board holding.
4. If your defense is non-infringement, the operative limitation is "free of preservatives." The D.N.J. construction adopted in Jazz v. Roxane (C.A. No. 10-6108, 2012-09-14) reads "preservative" as "a substance or substances added in addition to the gamma-hydroxybutyrate salt to inhibit chemical change or microbial action." Products that contain any such added substance fall outside claim 1 — which is precisely why Par and Amneal won this fight in court rather than at the Board.
5. Watch for reissue, continuation, or a new Orange Book listing rather than for new PTAB proceedings. Given the '219's expiry, the realistic future risk is not an IPR but Jazz's continued prosecution of later '431-family continuations (the '619, '062, '302, and '426 patents) asserting claims crafted around a competitor's ANDA — the conduct the generics have characterized as "evergreening" in their antitrust pleadings. Any new assertion against you will likely ride on those later patents, not on the '219.

Confidence note. High confidence that no IPR/PGR/CBM was ever filed against US 7,262,219 — it is the ODP default, it is corroborated by patent-specific litigation trackers showing no PTAB rows, and it is consistent with the absence of PGR/CBM eligibility and with where the generics actually aimed their petitions. I could not run a direct PTAB E2E proceeding-number search due to tool-step limits, so if you need a belt-and-suspenders confirmation, query PTAB E2E by patent number 7,262,219 and by the '431 family for any 2022–2026 filings; the ODP ingest lag is the only residual uncertainty. Nothing above should be read as stating that any '219 claim was held patentable — the Board has never ruled on this patent.

I'll start by gathering information from the assignment record and cross-referencing sources.

Let me try to access the USPTO Assignment Center records directly and gather more context.

I've gathered the available evidence. One important limitation up front, which I'll repeat in the relevant sections: I was able to retrieve the Google Patents legal-events ("Reassignments") feed for US 7,262,219 — which is derived from USPTO assignment records and gives conveyance type, assignor, assignee and a date — but I was not able to pull the underlying USPTO Assignment Center records (reel/frame numbers and correspondent of record) from my available sources. I will not invent reel/frame or correspondent values. Where the prompt requires them, I say so explicitly.

Ownership analysis — US 7,262,219 B2

Data provenance: Google Patents legal events (reassignment feed) at https://patents.google.com/patent/US7262219/en — dates and conveyance types reproduced verbatim from that feed. Reel/frame and correspondent-of-record were not retrievable and are flagged as such. Verify at https://assignmentcenter.uspto.gov/ (search by patent number 7262219).

Inventors

Pattern assessment: I did not find evidence of the anomalous pattern you flagged (all inventors departing the original assignee within 12 months of filing, which often precedes a portfolio fire-sale). To the contrary, this family stayed inside one corporate family from filing (1998 priority) through the present. I could not independently confirm each inventor's employment from a primary source, so the employer column is an inference from the assignment record, not a documented fact.

Original assignee

Orphan Medical, Inc., Minnetonka, Minnesota (a Minnesota corporation; principal offices at 13911 Ridgedale Drive, Minnetonka, MN 55305 — per the 1996 Lonza supply agreement reproduced in Jazz's SEC filings).

• Primary line of business: Specialty/ethical pharmaceuticals targeting defined patient populations. Its flagship asset was sodium oxybate under the brand Xyrem.
• Did it ship a product embodying the claims? Yes. Xyrem (sodium oxybate) oral solution received FDA approval on July 17, 2002 — contemporaneous with this patent family. US 7,262,219 is Orange Book–listed for NDA 021196 (Xyrem) as a drug product patent.
• Current status: Acquired. Jazz Pharmaceuticals, Inc. acquired Orphan Medical under an Agreement and Plan of Merger dated April 18, 2005, via merger sub Twist Merger Sub, Inc.; the acquisition closed June 24, 2005 (Jazz SEC filings reference "the acquisition of Orphan Medical, Inc. on June 24, 2005"). Orphan Medical was later converted/merged into Orphan Medical, LLC, which is now a Jazz subsidiary.
• Legal blemish on the original assignee (context, not an NPE signal): On July 13, 2007, Orphan Medical, Inc. entered a criminal plea agreement with the U.S. Attorney for the Eastern District of New York (21 U.S.C. §§ 331(a), 333(a)(2)) with restitution of $12,262,078 and an estimated Guidelines fine range of $28.5M–$57M, plus a related civil settlement, arising from Xyrem marketing conduct. This is a compliance event, not a bankruptcy or fire-sale event.

Assignment timeline

Critical caveat: the USPTO Assignment Center record for this patent — including reel/frame numbers and the correspondent of record on each conveyance — was not retrievable from the sources available to me. I am therefore reproducing the conveyance chronology exactly as it appears in the Google Patents reassignment feed, which does not expose reel/frame or correspondent. Dates below are the dates carried on the record; I cannot distinguish execution date from recording date, so each is presented once, labeled as recorded, with the gap explicitly noted where material. No reel/frame numbers are asserted.

Also note: several entries below are not title transfers at all — they are security interests, releases, and intra-group merger steps. I flag the character of each.

• 2005-07-29 (recorded) — Reel/frame: not retrievable

  • Conveyance: Security Interest (see document for details)
  • Assignor: Twist Merger Sub, Inc.
  • Assignee: LB 1 Group Inc. (Lehman-affiliated lender)
  • Correspondent: not retrievable — cannot confirm or rebut recurrence.
  • Context: Securitization — a lender took a security interest, not an ownership transfer; Twist Merger Sub was Jazz's acquisition vehicle for Orphan Medical.

• 2008-04-04 (recorded) — Reel/frame: not retrievable

  • Conveyance: Security Agreement
  • Assignor: JPI Commercial, LLC
  • Assignee: LB I Group Inc.
  • Correspondent: not retrievable — cannot confirm or rebut recurrence.
  • Context: Securitization — JPI Commercial, LLC (a Jazz financing subsidiary; it issued senior secured notes in March 2008 per the 10-K) pledged assets to LB I Group.

• 2010-06-30 (recorded) — Reel/frame: not retrievable

  • Conveyance: Security Agreement
  • Assignor: JPI Commercial, LLC
  • Assignee: Silicon Valley Bank
  • Correspondent: not retrievable.
  • Context: Securitization — secured lending facility.

• 2010-06-30 (recorded) — Reel/frame: not retrievable

  • Conveyance: Release by Secured Party (see document for details)
  • Assignor: LB I Group, Inc.
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrievable.
  • Context: Securitization unwind — release of the earlier LB I Group security interest.

• 2010-11-12 (recorded) — Reel/frame: not retrievable

  • Conveyance: Merger
  • Assignor: Orphan Medical, Inc.
  • Assignee: Orphan Medical, LLC
  • Correspondent: not retrievable.
  • Context: Internal reorg — operating subsidiary converted into an LLC within the Jazz family.

• 2010-11-12 (recorded) — Reel/frame: not retrievable

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: Orphan Medical, LLC
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrievable.
  • Context: Internal reorg — title moved to Jazz's IP/financing holding subsidiary.

• 2010-11-17 (recorded) — Reel/frame: not retrievable

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: JPI Commercial, LLC
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrievable.
  • Context: Internal reorg — step back up to the Jazz operating parent.

• 2010-11-26 (recorded) — Reel/frame: not retrievable

  • Conveyance: Merger
  • Assignor: Orphan Medical, Inc.
  • Assignee: Orphan Medical, LLC
  • Correspondent: not retrievable.
  • Context: Internal reorg — appears to be a corrective/re-recorded duplicate of the 2010-11-12 merger step; the near-identical pairing on 11-12 and 11-26 (and again for the JPI Commercial assignment on 11-26/12-22) strongly suggests recordation corrections rather than genuinely distinct transfers.

• 2010-11-26 (recorded) — Reel/frame: not retrievable

  • Conveyance: Assignment
  • Assignor: Orphan Medical, LLC
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrievable.
  • Context: Internal reorg — duplicate of the 2010-11-12 assignment.

• 2010-12-22 (recorded) — Reel/frame: not retrievable

  • Conveyance: Assignment
  • Assignor: JPI Commercial, LLC
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrievable.
  • Context: Internal reorg — duplicate of the 2010-11-17 assignment.

• 2011-12-30 (recorded) — Reel/frame: not retrievable

  • Conveyance: Assignment
  • Assignor: Silicon Valley Bank
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrievable.
  • Context: Securitization unwind — return of the collateral interest previously held by Silicon Valley Bank.

• 2012-08-06 (recorded) — Reel/frame: not retrievable

  • Conveyance: Security Interest (see document for details)
  • Assignor: EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: Barclays Bank PLC, as collateral agent
  • Correspondent: not retrievable.
  • Context: Securitization — a multi-entity Jazz collateral grant in favour of a lender group, coincident with Jazz's 2012 refinancing.

• 2015-06-19 (recorded) — Reel/frame: not retrievable

  • 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 retrievable.
  • Context: Securitization — replacement collateral agent / refinancing.

• 2015-07-09 (recorded) — Reel/frame: not retrievable

  • Conveyance: Release by Secured Party
  • Assignor: Barclays Bank PLC, as collateral agent
  • Assignee: Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals, Inc.; EUSA Pharma (USA), Inc.
  • Correspondent: not retrievable.
  • Context: Securitization unwind — release of the Barclays security interest on refinancing.

• 2021-05-05 (recorded) — Reel/frame: not retrievable

  • Conveyance: Release by Secured Party
  • Assignor: Bank of America, N.A., as collateral agent
  • Assignee: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals International III Limited; Celator Pharmaceuticals, Inc.; Cavion, Inc.; Jazz Pharmaceuticals Ireland Limited
  • Correspondent: not retrievable.
  • Context: Securitization unwind — release of the Bank of America security interest.

One gap worth flagging: the feed does not show the original inventor→Orphan Medical assignment (which would have been recorded around 1999–2000 on the parent application 09/470,570). Its absence from this feed is a data-completeness artifact, not evidence that it doesn't exist.

Continuity chain (prosecution, not assignments), for context: this patent is a divisional of 10/194,021 (filed 2002-07-11, issued as US 6,780,889), itself a divisional of 09/470,570 (filed 1999-12-22, issued as US 6,472,431), which claims priority to provisional 60/113,745 (filed 1998-12-23).

Timeline diagram

timeline
    title Ownership of US 7262219
    1998 : Priority application filed
    1999 : Parent application filed
    2002 : Xyrem FDA approval
    2004 : Divisional application filed
    2005 : Orphan Medical acquired by Jazz
    2007 : Patent issued as 7262219
    2010 : Orphan Medical merged into LLC
         : Title moved to JPI Commercial LLC
         : Title moved to Jazz Pharmaceuticals Inc
    2012 : New Jersey generic suits filed
    2013 : Additional New Jersey suits
    2015 : Bank of America collateral interest
    2021 : Collateral interest released

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The entities that look like candidates — JPI Commercial, LLC (2010-11-12, 2010-11-26, 2011-12-30) — are not anonymous shells. JPI Commercial, LLC is described in Jazz's own SEC filings as "a wholly-owned subsidiary of Jazz Pharmaceuticals" that "issued senior secured notes" in March 2008 (10-K, exhibit 4.5A–4.5C). Its documented function is intra-group financing and collateral, and the same corporate family appears on both sides of every 2010 transfer. There is no outbound transfer to a licensing-only vehicle and no registered-agent addresses or single-member-LLC tells in the record I retrieved.

2. Known asserter in the chain — Not present. No assignee in this chain appears on any public NPE list. Jazz Pharmaceuticals, Inc. is an operating pharmaceutical company whose oxybate products (Xyrem, Xywav) are FDA-approved and commercially marketed; it is the plaintiff, not a licensee-asserting shell, in the Xyrem/Xywav litigation (e.g. Jazz Pharmaceuticals, Inc. v. [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC), D.N.J. 2:13-cv-00391; Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, D. Del. 1:21-cv-01594).

3. Repeat correspondent across the chain — Unclear / not verifiable. The correspondent of record is not exposed in the source I could retrieve. I will not name a correspondent without a reel/frame to cite. Because Jazz's chain is a single corporate family with one securities counsel of record (Cooley Godward Kronish LLP acted as Jazz's counsel in the 2008–2010 window per SEC filing consents), recurrence here would be expected and benign — but that is a hypothesis, not a finding. Verify each assignment's correspondent field directly in Assignment Center.

4. Cascading transfers — Present as a factual pattern, but not an NPE pattern. There are six assignment/merger recordings between 2010-11-12 and 2010-12-22 (a ~6-week window), which superficially fits the "chained transfers in <24 months" tell. However, every assignor and assignee in that window is an affiliate of the same Jazz corporate family (Orphan Medical, Inc. → Orphan Medical, LLC → JPI Commercial, LLC → Jazz Pharmaceuticals, Inc.), and the entries appear duplicated (the 11-12 and 11-26 merger steps and the 11-17 and 12-22 assignment steps are the same transfer recorded twice). This reads as a corporate housekeeping / recordation-correction sequence, not shell-to-shell laundering.

5. Pre-litigation transfer — Not present on these dates. The intra-group transfers culminating on 2010-12-22 (Jazz Pharmaceuticals, Inc. as assignee) precede the earliest litigation entries surfaced for this patent — the New Jersey District Court cases recorded 2012–2015 (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) and NY Eastern 2:17-cv-04439 — by roughly 18 months, well outside the 6-month window that would indicate a transfer arranged specifically to enable assertion. (Caveat: I could not establish the earliest actual filing date with certainty; the litigation links in the feed are case records, not filing dates.)

6. Bankruptcy fire-sale — Not present. Orphan Medical was acquired in a solvent merger (closed 2005-06-24), not a bankruptcy sale. The 2007 DOJ plea agreement and civil settlement against Orphan Medical involved restitution and a fine, and there is no Chapter 7/11 proceeding in the record. Jazz's later financings (Barclays 2012, Bank of America 2015) are secured-note collateral arrangements, not asset sales out of insolvency.

7. Privateering — Not present. Privateering requires an operating company to hand the patent to a third-party NPE that asserts on the operating company's behalf. Here the operating company kept the patent (Jazz Pharmaceuticals, Inc. is the assignee of record as of 2010-12-22) and asserts it in its own name against genuine generic and branded competitors. That is ordinary operating-company enforcement, the opposite of privateering.

8. Defensive aggregator — Not present. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. The last recorded title event leaves the patent with Jazz Pharmaceuticals, Inc. and affiliated Jazz entities; the 2015 and 2021 entries are collateral releases, not transfers to a defensive aggregator.

Verdict

Operating-company assertion.

The recorded chain never leaves the Jazz corporate family: every one of the six 2010 entries runs Orphan Medical, Inc. → Orphan Medical, LLC → JPI Commercial, LLC → Jazz Pharmaceuticals, Inc., and the later entries (2012-08-06, 2015-06-19, 2015-07-09, 2021-05-05) are security interests and releases by secured parties, not sales to an asserting shell. JPI Commercial, LLC — the entity whose LLC suffix might otherwise raise a flag — is documented in Jazz's own SEC filings as a wholly-owned financing subsidiary, and it appears on both sides of the 2010 transfers. There is therefore no shell-entity transfer, no known NPE in the chain, no bankruptcy sale, and no defensive-aggregator terminus; instead, the owner of record is an operating pharmaceutical company that markets the patented product (Xyrem, Orange Book–listed under this patent) and sues actual competitors (Amneal, Avadel, et al.) in its own name.

Confidence and caveats: I rate this operating-company assertion with reasonable confidence on the identity and character of the parties, because the conveyance types and entity names come straight from the USPTO-derived reassignment feed and are corroborated by Jazz's SEC filings. I rate the reel/frame and correspondent-dependent signals (3 and, in part, 4) as unverifiable on my data — please confirm those fields directly at https://assignmentcenter.uspto.gov/ by searching patent number 7,262,219, and treat any correspondent-recurrence claim as open until you do.

I'll research the prior-art citations for US 7,262,219 across USPTO and patent databases. Let me run several targeted searches.

Let me pull the actual front-page references cited list from patent databases.

Let me pin down the exact front-page references of the '219 patent itself.

Prior-Art Analysis — US 7,262,219 B2

Scope and sourcing note (read first)

You asked me to search USPTO for the specific number 7,262,219 and to work through each patent citation on that patent. Two important limits on what follows:

1. I could not pull the verbatim PTO-892 / "References Cited" block from the '219 face itself within this session. The '219 is a divisional (of 10/194,021 → US 6,780,889, itself a divisional of 09/470,570 → US 6,472,431), and divisional front pages typically carry forward the parent's cited art. I therefore reconstructed the citation list from the family's own front pages (notably US 8,263,650, which shares the identical title and inventor set and reproduces the inherited reference block), from the '219 specification's own self-citations, and from IPR/prosecution records for the parent '431 patent. I flag confidence per item.
2. The reference list that appears inside IPR petition documents 1459711 / 1459762 cannot be the '219's own face list — it includes post-issuance patents (US 7,851,506; US 8,263,650; publications 2007/0270491, 2011/0039929, 2012/0020833). Those items were published after the '219 issued (Aug. 28, 2007) and so cannot have been cited on its face. They belong to a later family member. I note this because it is a direct contradiction with any reading that treats that block as the '219's citations.

Sources used: Google Patents US7262219B2 (authoritative text provided); USPTO PTAB petition files 1459711 / 1459762 / 1461686 (ptacts.uspto.gov); CourtListener D.N.J. 2:10-cv-06108 Doc. 156 (front page of US 8,263,650, same family); Justia patent pages (forward-citation lists); and the '219 specification's explicit self-citations.

A. Patent citations (references cited) — U.S. Patent Documents

The following are the U.S. patents appearing on the face of the Cook/Orphan Medical GHB family (as reproduced on the sibling US 8,263,650 front page), restricted here to those that pre-date the '219's Aug. 28, 2007 issuance and could therefore appear on the '219.

B. Foreign patent citations (family front page)

C. §102 anticipation analysis (claim-by-claim)

Claim 1 (independent) requires, together: (a) an aqueous solution of ~350–750 mg/mL sodium GHB; (b) a pH-adjusting agent selected from 8 named organic acids (malic, citric, acetic, lactic, carbonic, formic, propionic, tartaric); (c) pH ~6–7.5; (d) chemically stable and resistant to microbial growth; and (e) free of preservatives. Claim 2 (400–650 mg/mL) and Claim 3 (malic acid) depend from it; Claim 4 is an independent "free of preservatives" claim (verbatim text unverified).

§102 requires a single reference disclosing every element. On the retrieved citations:

• US 4,393,236 (Klosa) and GB/EP 922,029 — disclose GHB salts only; no concentrated aqueous solution, no pH-adjuster-at-pH-6–7.5, no preservative-free microbial-resistance feature. Anticipate no claim.
• US 4,983,632 (Gessa) — the closest single reference: discloses aqueous GHB salt compositions whose concentrations can reach ~500 mg/mL, squarely inside claim 1's 350–750 mg/mL window, and (per the '431 IPR record) formulations intended for human administration. However, it does not expressly disclose the specific organic-acid pH adjuster, a pH of 6–7.5, or the "chemically stable and resistant to microbial growth… free of preservatives" combination. → Potentially anticipates at most a concentration-only subset of claim 1; not the full claim. Best characterized as the lead §103 reference (Gessa + CA 338; Gessa + Auler; Gessa + EP '804 per the '431 IPR grounds).
• US 5,380,937 / US 5,753,708 (Koehler) — GHB organic salts/amides, not aqueous concentrates at defined pH. Anticipate no claim.
• US 5,840,331 (Van Cauter), US 5,990,162 (Scharf) — method-of-treatment art. The '219 claims are composition claims, so these cannot anticipate claims 1–4. (They are potentially §102(e)/§103 art against method claims in the sibling '431 patent.)
• US 4,374,441 (Carter), US 4,738,985 (Kluger), US 5,594,030 (Conte) — general pharmaceutical-formulation art; no element disclosure matching the claim 1 combination. Anticipate no claim (subject to content verification).
• US 6,436,998 (Cacciaglia) — GHB-containing composition art; possibly closer on the active+vehicle, but no verified disclosure of pH 6–7.5 with the specified organic-acid adjuster and preservative-free microbial resistance. Likely §103 only.
• EP 0 616 804 ("EP '804") and CA 338 — relied on in combination with Gessa in the '431 IPR; individually non-anticipatory.

Bottom line on §102: On the citations retrieved, no single reference discloses every element of claim 1 — in particular the conjunction of (i) a specified organic-acid pH adjuster, (ii) pH 6–7.5, and (iii) being free of preservatives while still resistant to microbial growth. The cited art therefore functions predominantly as §103 obviousness material, not §102 anticipation. This is consistent with the litigation history: the '431 IPR was pleaded entirely under §103 (Grounds using Gessa, CA 338, EP '804, and the Vickers 1969 NPL reference), and the central dispute in the Roxane/Par matters was claim construction of "preservative" (construed as a substance added in addition to the GHB salt), not §102.

D. Most relevant prior art (ranked)

1. US 4,983,632 — Gessa et al. (Jan. 8, 1991) — closest to the claimed aqueous GHB composition/concentration; primary §103 anchor.
2. EP 0 616 804 ("EP '804," Sep. 28, 1994) — GHB formulation art used in the '431 IPR combination.
3. CA 338 and Vickers (1969) — secondary §103 references from the '431 IPR.
4. US 4,393,236 (Klosa) / GB 922,029 — the salts/analgesic backbone art that the '219 spec itself identifies as the field's starting point.
5. US 5,990,162 (Scharf) and US 5,840,331 (Van Cauter) — treatment-method context (§102(e) only given the Dec. 1998 priority).

E. Explicit uncertainties and contradictions

• Verbatim face-citation list for the '219 was not retrieved. Items 1, 3, 6, 8–9 and all foreign items marked "Low/Medium" are drawn from the family front page and/or the spec; their presence on the '219 specifically is inferred, not confirmed.
• Contradiction flagged: the reference block inside IPR petitions 1459711/1459762 (which the earlier analysis associated with the '219) lists post-2007 patents and thus cannot be the '219's face citations — treat that block as belonging to a later family member.
• Claim 4's verbatim text remains unverified (consistent with the prior section).
• None of the above should be read as a legal conclusion of invalidity; the §102/§103 characterizations are analytical and depend on the unverified reference contents noted above.

I'll ground this obviousness analysis in the actual prior-art record — the references cited on the face of the patent, the family's prior filings, and the IPR/litigation record — rather than reasoning from memory.

Strong lead: Par's 2013 invalidity statement (PTAB petition 1459711) contains an explicit §103 chart for the '219 claims. Let me pin down the actual references it relies on.

Obviousness Analysis — US 7,262,219 Under 35 U.S.C. § 103

Note on the source base. The prior-art record below is drawn from (i) the references cited on the face of the '219 patent and in its Background, (ii) the Nov. 30, 2006 Office Action and Feb. 21, 2007 Amendment in the '709 application's prosecution history, and (iii) Par Pharmaceuticals' Nov. 20, 2013 invalidity statement filed in PTAB petition 1459711, which contains an express section-by-section §103 chart against claims 1–4. Where I rely on a party's characterizations (Par's, or its expert Dr. Tarantino's) rather than the reference text itself, I say so.

I. Legal framework and the operative date

• Pre-AIA § 103 governs. The '709 application was filed May 7, 2004; the '219 patent issued Aug. 28, 2007. No AIA § 3 reform applies. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) supplies the controlling standard because KSR post-dates issuance.
• Effective date. The '219 takes a § 120 chain: provisional 60/113,745 (Dec. 23, 1998) → 09/470,570 (Dec. 22, 1999, issued as US 6,472,431) → 10/194,021 (Jul. 11, 2002, issued as US 6,780,889) → 10/841,709. Claim 1 as issued (a 350–750 mg/mL range, an eight-member acid Markush, pH 6–7.5, preservative-free) is materially broader than the 500 mg/mL/malic acid/pH 7.5 species discussed in the specification. This does not weaken the §103 case — the two load-bearing references (Gessa 1991; Van Cauter, issued Nov. 24, 1998) predate both the Dec. 1998 provisional and the Dec. 1999 '570 filing. Whether the claims are even entitled to Dec. 1998 is a § 112/priority question, not a § 103 escape hatch here.
• Claim construction inputs that matter:
  • "about" — the specification supplies its own definition: "the term 'about' generally means within about 10–20%" (col. 4). Par relies on this to bring 302.5 mg/mL within "about 350 mg/mL."
  • "preservative" — the D.N.J. court in Jazz v. Roxane (No. 10-6108) construed it as a substance "added in addition to the gamma-hydroxybutyrate salt to inhibit chemical change or microbial action" (per the IPR petition's recitation of the construction).
  • "resistant to microbial growth" — defined in the specification by reference to FDA/USP criteria (≥1.0 log reduction at 14 days; no increase at 28 days), i.e., a test-defined functional property, not a compositional difference.

II. The prior-art references and what each supplies

Also relevant on the record: Cacciaglia, US 6,436,998, and '889 claim 1, cited by the Examiner on the obviousness-type double patenting rejection that the applicants cleared only by filing a terminal disclaimer. Under In re Berg, In re Braithwaite and In re Longi, the filing of a terminal disclaimer is an implicit concession that the '219 claims are not patentably distinct from the '889 genus — a strong structural signal that the added limitations of claim 1 (numerical range, acid selection, pH window, preservative-free) were viewed as obvious variations.

III. Grounds of rejection

Ground 1 (the Examiner's actual ground): Gessa '632 + Van Cauter '331 + admitted prior art

This is the rejection of record: claims 65–71 (the '219 claim set) were rejected under § 103(a) over Gessa in view of Van Cauter and the admitted prior art.

Element mapping to claim 1:

• "aqueous solution of about 350–750 mg/ml sodium gamma-hydroxybutyrate" — Gessa's 125–500 mg/mL range overlaps the claimed 350–500 sub-range; its 302.5 mg/mL examples fall within "about 350" under the specification's own 10–20% definition. Overlapping ranges with no demonstration of criticality are prima facie obvious. In re Peterson, 315 F.2d 571 (CCPA 1963); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). Nothing in the intrinsic record identifies a criticality at 350 mg/mL — the patent's own threshold is 150 mg/mL, not 350.
• "pH adjusting agent is malic acid, citric acid, acetic acid, lactic acid, carbonic acid, formic acid, propionic acid or tartaric acid" — the 1995 USP lists these (or their close congeners) as known pharmaceutical acidulants. Selecting one of eight known, functionally interchangeable pH adjusters is the paradigm KSR "finite number of identified, predictable solutions." 550 U.S. at 421.
• "pH of about 6–7.5" — CA 338 expressly teaches adjusting ≥200 mg/mL GHB solutions to pH 7.2–7.7, squarely overlapping the claimed window and supplying the reason to move Gessa's high-pH solutions downward.
• "chemically stable and resistant to microbial growth" — a test-defined performance property. Par's argument (and it is legally sound as a framing) is Schering Corp. v. Geneva Pharms., 339 F.3d 1373 (Fed. Cir. 2003) and Atlas Powder Co. v. Ireco, 190 F.3d 1342 (Fed. Cir. 1999): a newly discovered property of an otherwise-known composition cannot confer patentability.
• "free of preservatives" — the admitted prior art used preservatives; removing a known and troublesome excipient was itself the stated problem in the '219 Background ("preservatives can adversely affect the pH and thus, GHB's stability"). That sentence is an admission of the motivation to go preservative-free.
• "consisting essentially of" — semi-closed form. Water and acidulant are the only constituents, which is exactly the Gessa/CA 338 formulation.

Motivation to combine: Gessa and Van Cauter are both GHB pharmaceutical formulation/use references; the '219's own background links the narcolepsy (Van Cauter-type) and alcohol/withdrawal (Gessa-type) uses in a single paragraph. A POSA seeking a stable, chronically administered oral GHB solution — motivated by the admitted need ("there is an immediate need for effective solutions of GHB that are stable to biological or chemical degradation") — would naturally look to both.

Ground 2: Gessa + CA 338 + USP acidulant list

This is the cleaner, more robust ground because it supplies the pH-adjustment teaching directly rather than by inference. CA 338 both identifies the problem (≥20% GHB solutions have "far too high a pH") and the solution (adjust to pH 7.2–7.7). Adding a pharmaceutically standard acidulant from the USP list is routine optimization. Reasonable expectation of success is satisfied by CA 338's express pH target. Par's expert additionally computed that Gessa's 125–500 mg/mL solutions would sit at pH ~9.36–9.66 (via pH = ½(log C + pKa + pKw), pKa 4.72), which frames the pH shift as a needed correction — I flag this as a modeled inference, not a measurement.

Ground 3: Ground 1 or 2 + Wickliffe

Wickliffe supplies the missing "free of preservatives / resistant to microbial growth" link by teaching that pH alone inhibits bacterial growth without added preservative. Combined with Ground 1 or 2, it renders the "preservative-free yet microbially resistant" combination obvious. Wickliffe's pH 2 / pH >9 examples do not teach away from pH 6–7.5 — they establish the general principle; they do not disparage the claimed window. Cf. In re Fulton, 391 F.3d 1195 (Fed. Cir. 2004) (teaching away requires critical disparagement).

Ground 4: The '889/'431 family + Cacciaglia '998 (ODP-derivative ground)

Given the terminal disclaimer over '889 claim 1 in view of Gessa or Cacciaglia '998, the '219 claim 1 differs from the disclaimed-against genus only by the numerical range, the acid Markush, and the pH window — all routine optimization of the prior art. This is a § 103 argument as much as an ODP one.

What is not available: anticipation

No single reference discloses all of claim 1. Gessa does not disclose pH 6–7.5, the specific acid Markush, the lower limit of 350 mg/mL, or preservative-freeness as a claim element. This is an obviousness case, not an anticipation case — which matters because Par's framing incorrectly imports inherency arguments into § 102; the inherency point belongs in the § 103 rebuttal analysis.

IV. The applicant's counterargument and its vulnerability

During prosecution (Feb. 21, 2007 Amendment) the applicants argued that even if prima facie obvious, the "self-sterilization" of GHB at the claimed concentrations/ pH was "unexpected," and noted that Examiner Fay had allowed the parent '431 claims on that basis.

This is the patent's principal non-obviousness theory, but it is weaker than it looks:

1. Inherency versus invention. Discovering that a known solution happens to be self-preserving is the Atlas Powder/Schering problem — "the discovery of a previously unappreciated property of a prior art composition … does not render the old composition patently new."
2. The specification undercuts "unexpectedness." The '219 state-of-the-invention text already reports the concentration threshold ("Compositions of GHB at or below 150 mg/ml are poorly resistant …; concentrations of GHB of greater than about 150 mg/ml … are believed to be suitably resistant") and the pH dependence (pH 6–7.5 "particularly resistant"). Plaintiffs' own specification thus frames self-preservation as a predictable function of concentration and pH, not a surprise.
3. Scope exceeds the demonstration. The strongest rebuttal to the unexpected-results argument: the data are essentially malic acid fixed at a handful of points, while claim 1 covers eight acids across a 350–750 mg/mL span and pH 6–7.5. Unexpected results must be commensurate in scope with the claims. In re Kao, 639 F.3d 1057 (Fed. Cir. 2011); In re Soni, 54 F.3d 746 (Fed. Cir. 1995). Claim 2 (400–650 mg/mL) and claim 3 (malic acid) are progressively narrower, so claim 3 is the most defensible and claim 2 the least on this theory.
4. The allowance gave no reasoning. Per Par's recitation, the Examiner allowed claim 1 without stated reasons, which strips the "Examiner recognized unexpectedness" argument of weight.

V. Secondary considerations — the realistic non-obviousness case

Any defense of the '219 must run through objective indicia:

• Commercial success — Xyrem's commercial formulation is 500 mg/mL sodium oxybate, pH 7.5 neutralized with malic acid, which reads on claims 1–3. That is a genuinely strong nexus to claim 1's composition, unlike most pharmaceutical-claim secondary-consideration showings.
• Unexpected results — as above; strongest for claim 3, weakest for claim 1.
• Long-felt need / failure of others — supported by the Background's recitation that prior solutions were unstable and contaminated.
• Licensing / industry acquiescence — the generic ANDA litigation wave (D.N.J. 2:13-cv-05450, 2:14-cv-07757, 2:15-cv-05619, 2:15-cv-06548, 2:17-cv-05487; E.D.N.Y. 2:17-cv-04439) cuts against the patentee: competitors designed around claims 1–4 rather than licensing, and Watson filed a declaratory judgment counterclaim of invalidity in 2:14-cv-07757.

The nexus weakness on the commercial-success prong is that Xyrem's market position is bound up with the distribution-system patents (e.g., US 7,668,730; 7,845,988) and the FDA-mandated single-pharmacy dispensing model — not solely with the preservative-free formulation. A court could apportion accordingly.

VI. Bottom line

• Claim 1: Vulnerable. Ground 1 (the Examiner's own ground) and Ground 2 (Gessa + CA 338 + USP acidulants) each supply every limitation, with the motivation to combine supplied both by the shared field and by the '219's own admissions of the problem (preservative instability; need for stable, concentrated, microbially resistant GHB solutions).
• Claim 2 (400–650 mg/mL): Vulnerable for the same reasons; the narrowing is a range optimization squarely within Gessa's 125–500 and CA 338's ≥200 mg/mL teachings.
• Claim 3 (malic acid): Least vulnerable. If any claim survives, it is the 500 mg/mL/malic acid/pH 7.5 species, where the unexpected-results record is at least coextensive with the claim — though the USP acidulant list and the applicants' own commercial selection of malic acid still support obviousness of "obvious to try."
• Claim 4: I cannot fully assess it. Par's own chart treats claim 4 as governed by the same "free of preservatives" limitation ("Par's Sodium Oxybate Solution Does Not Infringe Claims 1-4 Because It Is Not Free of Preservative"), and the chart's claim-4 row is truncated to "4." on the record I retrieved. Its verbatim text was not authoritatively obtained in this analysis, and I will not reconstruct it. If claim 4 in fact recites the 500 mg/mL / malic acid / pH 7.5 / preservative-free species (as original claims 62–63 of the '709 application did), then it too is reachable via Gessa + CA 338 + Wickliffe + the USP acidulant list.

VII. Explicit uncertainties and discrepancies to flag

1. "Ser. No. 09/497,570" vs. "09/470,570." Par's Nov. 20, 2013 submission refers to the parent as "Ser. No. 09/497,570 which issued as U.S. Patent No. 6,472,431." The '219 patent's own RELATED APPLICATIONS section states the '431 patent issued from 09/470,570. I record this as an apparent transcription discrepancy in the petition and do not silently correct it; the identifier as written in that source is 09/497,570.
2. Wickliffe is not fully identified. The Par chart's citation is truncated ("See, e.g., p. ___"). I have characterized only what the chart attributes to it; I have not verified the underlying document. A web search for "Wickliffe" returns an unrelated 2023 FDA Form 483 for Wickliffe Veterinary Pharmacy, which must not be conflated with the Wickliffe reference cited in the petition.
3. "CA 338" is cited only by the short form used in Dr. Tarantino's declaration (WCK1005); I did not retrieve its full Canadian application number or text. The pH 7.2–7.7 teaching is attributed to its abstract, per that declaration.
4. The Examiner's "admitted prior art (p. 12, lines 3–8)" — I could not map those page/line numbers to column/line cites in the granted specification (Google Patents' text lacks column numbering). The content most consistent with that citation is the described 150 mg/mL GHB liquid containing preservatives and flavoring agents. I flag this as an inference, not a verified quotation.
5. The pH 9.36–9.66 computation for Gessa is the petitioner's expert's modeled inference, not a measured value, and should be treated as contested.
6. Van Cauter's 5,849,331-type disclosures appear in the record in Par's chart addressing a different Jazz patent (the '275 patent). The substance is prior art regardless of which claim chart it appears in, but the claim-by-claim citations in Par's chart are organized by patent and I have not verified each pin cite against the '331 text myself.
7. An unverified item: a Google Patents citation row references IT1248588B (1991-06-28 / 1995-01-19, Gaetano Crepaldi) alongside the title "Microbial safe and stable solution of gamma-hydroxybutyrate for the treatment of sleep attacks," and the same page lists EP 1316309 A1 with the '219's title. I could not determine from the retrieved snippet whether IT1248588B is a family member of the '219 or an independent, potentially anticipatory prior-art reference. It warrants direct verification before being relied on in any § 103 (or § 102) ground, since a 1995 publication date would place it before every candidate priority date.

Sources consulted: https://patents.google.com/patent/US7262219/en ; https://ptacts.uspto.gov/ptacts/public-informations/petitions/1459711/download-documents?artifactId=SuU1kui1xQlxY2eMXqnGf4dxsmr3N82Oy7p6M5iMb45oec_J6YmOzvQ ; https://ptacts.uspto.gov/ptacts/public-informations/petitions/1459711/download-documents?artifactId=QKAvc3-OSfkt5IF9IxVwyfokRSLkt0i5wRvlIdmCid3Fj9ZP2aC3rT8 ; https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1461686](/patent/1461686)/download-documents?artifactId=1ym1yzOhXni9ychHoI8DsTXFfRVjSGJo0r4wE7p3HKNbPFuCpgUrWv8 ; https://patentimages.storage.googleapis.com/87/2b/6b/a4130a8b65402c/US5840331.pdf ; https://patents.justia.com/patent/[4983632](/patent/4983632) ; https://patentimages.storage.googleapis.com/bd/05/52/e81c890ef11f6a/EP0344704B1.pdf ; https://patentimages.storage.googleapis.com/d4/3d/6a/44bfbdd9342b49/US5594030.pdf ; https://paragraphfour.com/uploads/cases14/njdc14cv7757A.pdf ; https://jazzpharma.gcs-web.com/static-files/029a1c81-07fb-4272-aa0c-a77be555c4df ; https://www.courtlistener.com/docket/[4310210/156](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=4310210-0156)/jazz-pharmaceuticals-inc-v-roxane-laboratories-inc/