US 6281230

I'll search for the specific patent number and any litigation/docket records, then summarize.

Let me verify the exact independent claim language and check for any 2026 appellate activity.

US Patent 6,281,230 — Summary (searched and verified)

Important scoping note: Everything below relates only to US 6,281,230 B1. I did not find any 2026 Federal Circuit (CAFC) docket entry naming this patent; see "Litigation / docket status" below for what I did and did not find, and for the uncertainties.

Bibliographic data

Sources: Google Patents US6281230B1, Justia, DrugPatentWatch.

Minor database discrepancies to flag (I am not auto-correcting them): Unified Patents lists the priority date as 1996‑07‑23, application date 2000‑04‑05, grant date 2001‑08‑27, and expiration 2016‑07‑23, whereas the patent front page and Google Patents state filed Apr. 6, 2000 and issued Aug. 28, 2001. I treat the patent front page as authoritative.

Abstract (verbatim)

"Substituted 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines are useful in treating inflammation, inflammatory disease, autoimmune disease, and oncogenic or cancerous conditions in a mammal. Typical embodiments are 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline and 1-oxo-2-(2,6-dioxo-3-methylpiperidin-3-yl)-4-aminoisoindoline."

The specification frames the invention as substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines that reduce TNFα levels and inhibit NFκB action, with pharmaceutical compositions thereof.

Independent claims — plain language

Claim 1 (independent — method of treatment; inflammatory/autoimmune)
A method of treating inflammation, an inflammatory disease, or an autoimmune disease in a mammal by administering an effective amount of a compound of the depicted formula in which R⁶ is hydrogen or methyl. Because only R⁶ is recited as variable, the remaining substituents are fixed by the drawn formula; consistent with the specification, the claimed compounds are amino-substituted 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines. The two named typical embodiments — the R⁶ = H compound (1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline, i.e., the lenalidomide scaffold) and the R⁶ = CH₃ compound (the pomalidomide scaffold) — fall within this genus.

Claim 18 (independent — method of treatment; oncology)
A method of treating an oncogenic or cancerous condition in a mammal by administering an effective amount of a compound of the depicted formula in which R⁶ is hydrogen or methyl.

Dependent claim structure

• Claims 2–17 depend (directly or indirectly) on claim 1: claim 2 narrows to a specific sub-formula; claims 3–11 recite specific indications (rheumatoid arthritis, osteoarthritis, inflammatory bowel disease — including Crohn's disease and ulcerative colitis, arthritic conditions, sepsis, lupus, erythema nodosum leprosum); claim 12 oral/parenteral administration; claim 13 combination with another therapeutic agent; claim 14 physiologically acceptable non-toxic acid addition salts; claims 15–16 R- and S-configurations; claim 17 dosing as a 1–100 mg pharmaceutical composition.
• Claims 19–26 depend (directly or indirectly) on claim 18: claim 19 narrows to a specific sub-formula; claim 20 oral/parenteral; claim 21 combination therapy; claim 22 the second agent is a steroid, neoplastic agent, or antibiotic; claim 23 acid addition salts; claims 24–25 R/S configurations; claim 26 dosing as a 1–100 mg composition.

Note: all 26 claims are method-of-treatment claims. Despite the title's reference to "pharmaceutical compositions," I found no independent composition claim — pharmaceutical compositions appear only in the specification (e.g., tablets, gelatin capsules, injectables).

Litigation / docket status

• New Jersey District Court litigation is linked to this patent family in Google Patents' Unified Patents data: case 2:12-cv-04571 and case 2:10-cv-05197 (litigation links).
• The patent is listed in a 2022 New Jersey complaint (Case 2:21-cv-20451-ES-JBC, D.N.J.) among Celgene patents not listed in the Orange Book, alongside the '554, '106, '326, '357, '219 and '598 patents (courtlistener PDF).
• At the PTAB, US 6,281,230 appears only as an exhibit (prior art/background), not the challenged patent, in IPR2018-01507, IPR2018-01509 and IPR2018-01714 (Alvogen Pine Brook LLC v. Celgene Corp.) (docketalarm).
• CAFC 2026: I did not locate any Federal Circuit 2026 docket, opinion, or appeal specifically involving US 6,281,230. Given the patent expired around July 2016, new 2026 appellate activity naming it as the asserted patent would be unusual (though not impossible in an IPR, antitrust, or damages context). My second search on this point returned no usable results, so I cannot affirmatively state either that 2026 CAFC activity exists or is absent — treat this as unverified.

Uncertainty flags

• Claim 1's exact full text: the formula image and full substituent definitions are not fully reproduced in the text feeds I retrieved. I confirmed the operative limitation "in which R⁶ is hydrogen or methyl" via DrugPatentWatch, but the fixed positions (amino/hydrogen placement) are inferred from the specification's named embodiments rather than read directly off the claim image. If you need claim-chart-grade precision, pull the granted claim set from USPTO Patent Public Search / PatentCenter for 09/543,809.
• I am not auto-correcting the priority/expiration/grant-date variants reported across Google Patents, Unified Patents, and Justia; they are reproduced as found.

I'll research litigation involving US 6,281,230. Let me run several targeted searches.

Let me dig deeper into the specific cases and search for additional ones.

Let me get the dedicated litigation page for this patent and check for additional cases.

Litigation involving U.S. Patent No. 6,281,230 (the "'230 patent")

Bottom line: Yes — there is known litigation. The '230 patent was asserted by Celgene in Hatch‑Waxman (ANDA) patent‑infringement suits over generic REVLIMID® (lenalidomide), and it also appears as one of the challenged REVLIMID patents in the long‑running Thalomid/REVLIMID antitrust litigation. Per the Orange Book, the '230 patent expired July 24, 2016.

Below, I separate cases where the '230 patent was asserted as a patent‑in‑suit from cases where it is merely identified/challenged as part of a patent portfolio. I flag my confidence level for each.

A. ANDA patent‑infringement suits in which the '230 patent was asserted

1. Celgene Corp. v. Natco Pharma Limited, Arrow International Limited, and Watson Laboratories, Inc.

• Court / Case No.: U.S. District Court for the District of New Jersey (Judge Susan D. Wigenton), Civil Action No. 2:10‑cv‑05197 (SDW) (MCA/SCM)
• Filed: October 8, 2010
• Plaintiff: Celgene Corporation
• Defendants: Natco Pharma Limited; Arrow International Limited; Watson Laboratories, Inc. (the stipulation also names Watson Pharmaceuticals, Inc., Actavis Inc., Watson Pharma, Inc., and Anda, Inc. within "Natco")
• '230 patent involvement (high confidence): Celgene asserted the '230 patent together with U.S. Pat. Nos. 5,635,517; 6,045,501; 6,315,720; 6,555,554; 6,561,976; 6,561,977; 6,755,784; 7,119,106; and 7,465,800. The Second Amended Complaint expressly identifies "6,281,230 (the '230 patent)" and attaches it as Exhibit C. Celgene's Fifth Amended Complaint (May 6, 2013) again asserted the '230 patent (along with the '517, '554, '106, '800, '415, '717 and '598 patents).
• Outcome / status:
  • Natco answered and counterclaimed (November 18, 2010) that its ANDA did not infringe and that the patents were invalid/unenforceable.
  • All claims and defenses relating to the '230 patent were dismissed. Docket No. 402, "Stipulation and Order of Dismissal of Claims and Defenses Relating to U.S. Patent Nos. 6,281,230, 6,555,554, 7,119,106, and 8,288,415," filed/entered March 26, 2015 (signed by Judge Wigenton; the docket entry's signature date reads "11/26/15" while the document header reads 03/26/15 — the docket text is internally inconsistent). The stipulation recites that Natco amended ANDA No. 201452 to replace paragraph IV certifications with paragraph III certifications for those patents, so no case or controversy remained; dismissal was without prejudice for lack of subject‑matter jurisdiction. Relatedly, an antitrust complaint in the same MDL alleges Celgene "stipulated to dismissing its claims and defenses as to the '230 and '554 patents (following the Court's adoption of Natco's proposed claim terms regarding these patents)."
  • Overall case: Settled December 22, 2015; consent judgment dismissing all claims with prejudice January 4, 2016; docket terminated January 5, 2016. Under the settlement, Natco/Arrow/Watson were enjoined from marketing unlimited generic lenalidomide until January 1, 2026, with a limited‑volume entry beginning March 2022 (the subject of later "pay‑for‑delay" antitrust challenges).
• Sources: CourtListener docket 4310166 (D.N.J. 2:10‑cv‑05197, Doc. 402); https://www.courtlistener.com/docket/[4310166/402](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=4310166-0402)/celgene-corporation-v-natco-pharma-limited/ ; Second Amended Complaint (10‑5197) reproduced at http://www.docketalarm.com/cases/[PTAB](/ptab)/IPR2015-01169/... ; https://www.drugpatentwatch.com/p/litigation/casename/CELGENE+CORPORATION+v.+NATCO+PHARMA+LIMITED%7C2%3A10-cv-05197

2. Celgene Corp. v. Synthon Pharmaceuticals, Inc. (and Alvogen Pine Brook, LLC)

• Court / Case No.: D.N.J. (Judge Esther Salas; Mag. Judge Michael A. Hammer), Civil Action No. 2:18‑cv‑10775
• Filed: June 19, 2018; terminated: May 13, 2019
• Plaintiff: Celgene Corporation; Defendant: Synthon Pharmaceuticals, Inc. (Alvogen Pine Brook, LLC listed as a party)
• '230 patent involvement (moderate confidence): The '230 patent is listed among the patents on DrugPatentWatch's docket for this case (along with 6,476,052; 6,555,554; 7,968,569; 8,198,262; 8,673,939; 8,735,428; 8,828,427; and 9,993,467), and the complaint text quotes "6,281,230 B1 8/2001 Muller et al." However, the case documents I could retrieve define the "Patents‑in‑Suit" in the consent judgment as the later patents (8,198,262; 8,673,939; 8,735,428; 8,828,427; etc.), so I cannot confirm the '230 patent survived as an asserted claim rather than appearing as background/listed‑patent citation.
• Outcome / status: Consent judgment / injunction (2019); case terminated May 13, 2019.
• Source: https://www.drugpatentwatch.com/p/litigation/casename/index.php?query=CELGENE+CORPORATION+v.+SYNTHON+PHARMECEUTICALS%2C+INC.%7C2%3A18-cv-10775

3. Celgene Corp. v. Natco Pharma Limited et al. — 2:12‑cv‑04571

• Court / Case No.: D.N.J., Civil Action No. 2:12‑cv‑04571
• Filed: July 20, 2012 (per Stanford NPE Litigation Database)
• Parties: Celgene Corporation (asserter; "product company") v. Natco Pharma Ltd. and related Natco/Watson/Arrow entities
• '230 patent involvement (low confidence): Google Patents lists this case in the "family has litigation" data for US 6,281,230, and the Stanford database records it. However, the Stanford NPE entry I retrieved attributes this same case number to U.S. Pat. 7,189,740, so I cannot confirm from the retrieved material that the '230 patent itself was pleaded in this 2012 action. Treat as "associated with the '230 patent family" rather than confirmed assertion.
• Source: https://npe.law.stanford.edu/patent/7189740 ; Google Patents litigation links for US 6,281,230.

B. Antitrust / consumer‑protection actions in which the '230 patent is one of the challenged REVLIMID patents

These are not patent‑infringement suits; the '230 patent is cited in the complaints as one of the allegedly invalid/unlawfully procured patents supporting Celgene's REVLIMID monopoly. Confirmed listing of the '230 patent in the pleadings/docket:

Sources: https://www.drugpatentwatch.com/p/alphasignals/litigation/patent/6281230 ; https://www.drugpatentwatch.com/p/litigation/casename/index.php?query=CenterWell+Pharmacy%2C+Inc.v.+Celgene+Corporation%7C1%3A24-cv-06924 ; Blue Cross complaint (#1 in D.D.C. 1:20‑cv‑01980) at https://www.courtlistener.com/docket/17368821/1/blue-cross-and-blue-shield-association-v-celgene-corporation/

Thalomid/REVLIMID antitrust class actions and opt‑out suits (D.N.J.), in which the '230 patent features in the allegations:

• International Union of Bricklayers and Allied Craftworkers Local 1 Health Fund v. Celgene Corp., D.N.J. 2:14‑cv‑06997 (filed Nov. 7, 2014)
• City of Providence v. Celgene Corp., D.N.J. 2:15‑cv‑01605 (filed March 3, 2015)
• MSP Recovery Claims, Series LLC v. Celgene Corp., D.N.J. 2:21‑cv‑20451 (alleges the '230 patent was invalid/unenforceable/not infringed by Natco's ANDA)
• Humana Inc. v. Celgene Corp., D.N.J. (filed March 1, 2019) — same subject matter; I have not independently confirmed that the '230 patent is named in the Humana complaint.
• The class actions were consolidated and largely resolved: class certification denied (Oct. 2018); settlement approved and case dismissed (Oct. 2020), with opt‑out actions (e.g., United HealthCare, CenterWell) proceeding; a consolidated REVLIMID "pay‑for‑delay" MDL survived motions to dismiss per a Sept. 2026 report.

Sources: https://www.courtlistener.com/docket/[4546789](/patent/4546789)/... ; https://www.courtlistener.com/docket/61609345/1/msp-recovery-claims-series-llc-v-celgene-corporation/ ; https://www.courtlistener.com:443/docket/[4311982](/patent/4311982)/1/city-of-providence-v-celgene-corporation/ ; BMS 2021 Form 10‑K antitrust disclosure.

C. PTAB / IPR

I found no inter partes review or other PTAB proceeding directed to U.S. 6,281,230 itself. The two PTAB proceedings I encountered in this patent family are IPR2015‑01103 (U.S. Pat. 6,315,720) and IPR2015‑01169 (U.S. Pat. 5,635,517) — different patents, so I am deliberately not reporting them as '230 litigation. (Source: IPR2015‑01103 Exhibit 1047, Orange Book listing showing '230 among REVLIMID patents.)

D. Caveats and limitations

• Sources used: I relied on Google Patents (patents.google.com/patent/US6281230/en), Unified Patents' litigation portal, CourtListener RECAP dockets, DrugPatentWatch, and the Stanford NPE Litigation Database, all retrieved today, April 26, 2026. Unified Patents' caselist page was not directly retrievable in usable form; I used its underlying Google Patents/Unified data links instead.
• Scope of the DrugPatentWatch '230‑patent list: The page assembled for patent 6,281,230 (https://www.drugpatentwatch.com/p/alphasignals/litigation/patent/6281230) returned only four rows in the version I retrieved (the United HealthCare, "DO NOT DOCKET," Blue Cross, and Louisiana Health cases). Because that list contradicts other sources that tie the '230 patent to the Natco and Synthon ANDA dockets, I treated it as incomplete rather than authoritative. A complete Westlaw/Lexis or Docket Navigator patent‑level search would be needed for exhaustiveness.
• Cases I could not confirm: I could not verify that the '230 patent was pleaded in Celgene v. Dr. Reddy's (D.N.J., filed July 20, 2017; that suit cited 7,189,740; 8,404,717; 9,056,120), Celgene v. Hetero (D.N.J. 2:17‑cv‑03387, filed May 11, 2017; a POMALYST® case), or the various 2017–2020 REVLIMID generic suits against Cipla, Zydus, Apotex, Lupa, Mylan, etc. The '230 patent apparently appears in some of those pleadings only as background citation ("Nos. 6,281,230 and 5,635,517").
• Date discrepancy noted, not corrected: The docket text for D.N.J. 2:10‑cv‑05197 Doc. 402 gives the signature date as "11/26/15" while the document itself is headed "Filed 03/26/15." I have flagged both rather than silently choosing one.
• Where I state a proposition with less than high confidence, I have said so explicitly above.

I'll verify the structured data against public sources, since this patent is a well-known Celgene/Revlimid patent.

I'll verify the structured data against public sources before reconstructing the chain.

I found a promising reel/frame reference in a court filing. Let me dig into that and other assignment records.

The reel 013982/0697 in that filing relates to a different Celgene application. Let me verify what's actually recorded against the '230 patent itself.

I verified what I could from primary and secondary sources. Important caveat up front: I was unable to retrieve the USPTO Assignment Center record set for US 6,281,230 with the tools available in this session. The reel/frame entries below are therefore limited to what I could independently corroborate. I flag one near-miss explicitly rather than misattribute it.

Inventors

Per the face of the patent (authoritative text provided):

Basis for employer attribution: the patent is assigned on its face to Celgene Corp, and the equivalent foreign filings in the same family (e.g. DE69631592T2, NO341035B1) list Celgene Corporation, 7 Powder Horn Drive, Warren, NJ 07059 as owner. Assignment-on-the-face plus common residential addresses in Somerset/Hunterdon County, NJ is consistent with employee inventors, but I have not verified individual employment agreements.

Data discrepancy to flag: the Unified Patents patent page for US-6281230-B1 renders a name block reading "Chen Roger Shen-Chu … Aulakh, Charanjit S." Charanjit S. Aulakh does not appear as a named inventor on the patent front page as provided. I could not determine whether this is a mis-scraped prosecution attorney, an agent for service, or a metadata artifact. I am not treating Aulakh as an inventor.

Unusual-departure pattern: none detectable. No evidence found of inventors leaving the assignee within 12 months of filing. Not a finding either way — the data simply isn't in front of me.

Original assignee

Celgene Corporation (at issue: "Celgene Corp"; Delaware corporation; principal address 7 Powder Horn Drive, Warren, NJ 07059).

• Primary line of business: branded pharmaceutical development and commercialization (immunomodulatory drugs, oncology, inflammation).
• Did it ship a product embodying the claims? Yes. The '230 patent covers substituted 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines; its typical embodiments are lenalidomide (4-amino) and the 3-methyl analog (pomalidomide). Lenalidomide is marketed as REVLIMID (NDA 021880, approved 2005-12-27 per FDA Orange Book records), and the '230 is listed against Revlimid with use codes U-769, U-1212, and U-1414 and an expiration of Jul 24, 2016.
• Current status: Celgene was acquired by Bristol-Myers Squibb in a stock transaction announced January 2019 and completed November 2019; Celgene is now a wholly-owned BMS subsidiary and remains a going concern. Not dissolved, not in bankruptcy.

Contradiction to flag: one generic-challenger pleading in D.N.J. characterizes the '230 as a patent Celgene "did not list in the Orange Book" while nevertheless accusing on it. FDA Orange Book cumulative supplements and third-party Orange Book mirrors both list 6281230 as a Revlimid patent. I could not resolve which statement is accurate; treat Orange Book listing status as contested.

Assignment timeline

I could not confirm any recorded assignment specific to US 6,281,230 from the Assignment Center via the tools available here. I am not going to manufacture reel/frame numbers.

The single reel/frame I surfaced in the record — Reel 013982 / Frame 0697, recorded 2003-04-23, assignee of record Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059 — is NOT an assignment of the '230 patent. The underlying papers (Docket No. CELG-0508, filed as an exhibit in Celgene Corp. v. Hetero Labs Ltd., D.N.J. 2:17-cv-03387, Doc. 250-30) recite a different application, Ser. No. 09/694,217, filed October 23, 2000, with named inventors Williams and Joseph J. Kaminski. I am flagging this because it is exactly the kind of Celgene-internal recording that could be misread as belonging to this family. It does not.

The only defensible ownership evidence I have for the '230 is:

• On the face of the patent / Google Patents "Current Assignee": Celgene Corp.
• No transfer to a licensing entity, holding LLC, or asserter appears anywhere in the records I could retrieve.
• Change-of-control, not change-of-record: BMS's 2019 acquisition of Celgene was a stock merger. Whether a separate USPTO assignment recording was made for the Celgene patent estate (common on a merger) could not be verified here.

Correspondent of record: not retrievable. Note for completeness — a Norwegian Patentstyret entry lists Camille M. Miller, Cozen O'Connor, PC, IP Group, 1900 Market Street, Philadelphia PA 19103 as Celgene's representative. That is foreign prosecution counsel, not an assignment-recording correspondent, and should not be used for the repeat-correspondent test.

If the Assignment Center returns records for this patent that differ from the above, those records should supersede this section.

Timeline diagram

Events below are verified facts (filing, issuance, regulatory, litigation, corporate control, expiry). Ownership-transfer links are omitted because I could not verify them.

timeline
    title Ownership of US 6281230
    1996 : Priority application filed
    2000 : Continuation filed by Celgene
    2001 : Patent issued to Celgene
    2005 : Revlimid approved and listed
    2010 : Celgene sues generics in NJ
    2012 : Second NJ suit filed
    2016 : Patent expires
    2019 : BMS acquires Celgene

NPE / troll-pattern signals

1. Shell-entity transfer — not present. No evidence of transfer to an "IP / Holdings / Licensing / Ventures" LLC. Google Patents lists the current assignee as Celgene Corp; the '230 family relatives (US5635517, US5798368, US6316471, US6476052, US6335349, US6555554, US7041680, US7119106) all resolve to Celgene. No single-purpose entity found.

2. Known asserter in the chain — not present. Neither Celgene Corporation nor Bristol-Myers Squibb appears on Acacia, Marathon, IV, IPNav, Wi-LAN/Mosaid/Conversant, Vringo, Pendrell, Innovatio, Round Rock, Lumen View, or Spangenberg-related directories. Both are operating manufacturers.

3. Repeat correspondent across the chain — unclear / not assessable. The assignment correspondent could not be retrieved, so the recurrence test cannot be run. No negative finding is implied — this is a gap, not a clean bill.

4. Cascading transfers — not present. No consecutive LLC-to-LLC chain was found in <24 months, and none would be expected for a compound patent held by a brand manufacturer.

5. Pre-litigation transfer — not present. The D.N.J. suits (2:10-cv-05197 and 2:12-cv-04571, both listed in Google Patents litigation data for this patent) were Hatch-Waxman/ANDA actions brought by Celgene against generic filers. There is no evidence the '230 was conveyed within 6 months before either filing to set venue or standing.

6. Bankruptcy fire-sale — not present. Celgene's exit was a ~$74B all-stock acquisition by BMS (completed Nov 2019), not a Chapter 7/11 proceeding. No Kodak/Nortel/Polaroid-style sale.

7. Privateering — not present. Assertion was made by the manufacturer itself, in its own name. That is aggressive brand-side ANDA enforcement (a generic-challenger complaint in the record does allege "sham" litigation and "baseless citizen petitions" — e.g. ¶¶310–312 of the excerpt located) but aggressive operating-company assertion is not privateering.

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. No neutralization event found.

Verdict

Operating-company assertion.

The patent was held and enforced by Celgene Corporation — the company that commercialized the claimed compound as REVLIMID (lenalidomide, NDA 021880) — and was asserted by Celgene itself against ANDA-generic competitors in the District of New Jersey (2:10-cv-05197 and 2:12-cv-04571), not by any licensing entity. No assignment to a shell, asserter, or defensive aggregator could be found, and Celgene's 2019 absorption by Bristol-Myers Squibb was a corporate acquisition rather than a portfolio sale. Caveat: because I could not retrieve the Assignment Center reel/frame set, this verdict rests on assignee identity, the Orange Book/product record, and litigation posture rather than on a verified chain of title; if the Assignment Center shows recordings I did not see, re-score accordingly.

Verify independently at: https://assignmentcenter.uspto.gov/ (search patent number 6281230) and cross-check the legal-events tab at https://patents.google.com/patent/US6281230/en.

What I could not establish: the recorded assignor/assignee/correspondent for any post-issuance assignment; whether a BMS merger recording exists for this patent; and the Orange Book listing-status conflict noted above. I would rather flag these as open than fill them in.

I'll research the prior art citations for US 6,281,230. Let me run several targeted searches.

Let me dig into the specific reference lists and the IPR proceedings.

Let me find the actual "References Cited" list on the patent's front page.

Prior Art Analysis — US 6,281,230 B1 ("Isoindolines, method of use, and pharmaceutical compositions")

1. Ground rules applied

• Patent/ID literalism. I have not normalized or "corrected" any number. Where two retrieved renderings of the face-of-patent list disagree, I report both and flag the discrepancy instead of silently picking one (§2, §5).
• Authority for the citation list. I could not open a live USPTO PatentCenter/PatentsView citation API from this session. The citation list below is taken from an image/text rendering of the front page of US 6,281,230 B1 itself, as filed of record in PTAB proceedings (the '230 patent was lodged as an exhibit — e.g., IPR2018-01507 Ex. 1006-5 and IPR2018-01509 Ex. 1006-5, and IPR2018-01714 Ex. 1028). Cross-checked against the "References Cited" of the closely related continuation US 6,476,052 (patentimages PDF). Where I could not independently verify a reference's subject matter, I say so rather than invent it.
• Building on the prior section. The earlier "PTAB challenges" block is only a stub. I note here: the challenged patent in IPR2018-01714 (Alvogen Pine Brook LLC v. Celgene Corp.) is U.S. 7,968,569 — not the '230 patent. The '230 patent appears in those filings only as prior-art Exhibit 1028. So the '230 patent has not itself been the subject of an instituted IPR on this record; it was asserted in the Hatch-Waxman litigations (D.N.J. cases 2:12-cv-04571 and 2:10-cv-05197 per the Google Patents family/litigation data).

2. Governing legal frame (pre-AIA § 102)

The '230 application (US 09/543,809) was filed 2000-04-06 and is a continuation/division tracing to PCT/US1997/013375 (filed 1997-07-24) which claims priority to US 08/690,258 (1996-07-24) and US 08/701,494 (1996-08-22). Pre-AIA 35 U.S.C. § 102 therefore applies, with an effective date no later than 1996-07-24.

Two consequences matter for the "which claims does it anticipate" question:

1. References issuing after 1996-07-24 are generally not § 102(a)/(b) prior art, and if their inventive entity/assignee is the same as the '230 (Muller/Stirling/Chen; Celgene), they are also not "by others" under § 102(a)/(e). Most of the long list of Muller/Celgene patents on the face is of this character — they are family members / related applications, not third-party anticipatory art. I flag the exceptions.
2. § 102 anticipation requires a single reference disclosing every claimed element. For a genus claim this normally means the reference must disclose the species with all recited substituents.

3. U.S. Patent Documents cited on the face of US 6,281,230 B1

Dates/inventors are as printed on the face. "§ 102 posture" reflects my analysis under §2. Descriptions marked (unverified) mean I could not confirm the reference's subject matter from the retrieved material.

Foreign patent document cited:

• WO 95/01348 (published 1/1995) — pre-priority PCT. Its subject matter is (unverified) in my retrieved material; it is on the face as the sole foreign document.

4. Non-Patent Literature cited on the face (most probative items)

5. Discrepancies and limits on confidence (must be read with the analysis)

1. "5,502,066" vs. "5,502,606." The face of the '230 patent is rendered as 5,502,606 in one OCR rendering (docketalarm IPR2018-01507/-01509 Ex. 1006-5) and 5,502,066 in the continuation US 6,476,052 (both "3/1996, Heinemann et al."). I did not auto-correct; treat the identifier as ambiguous pending a certified copy.
2. "5,992,117" date appears as 7/1999 in one rendering and 11/1999 in another. Unresolved.
3. Several 1997–2000 Celgene references are listed with titles I could not verify; I marked them (unverified) rather than guess. If a precise title/claim-scope is needed for a § 102 chart, the certified copies should be pulled.
4. Same-inventor / same-assignee problem. A large fraction of the cited U.S. references are Muller/Celgene patents of the same family lineage as the '230. Under pre-AIA § 102 these are not anticipatory "by others" art; their presence on the face reflects related-application citation practice. The only genuinely third-party cited references are the D'Amato angiogenesis patents, Kaplan 5,385,901, Heinemann, the pre-1989 imide patents, WO 95/01348, and the non-patent literature.
5. The two parent applications are the most dangerous art on the face — US 5,635,517 (amino-substituted genus) and US 5,798,368 (tetrasubstituted 1-oxoisoindoline genus) map almost one-to-one onto the two branches of '230 claim 1. Their exclusion as anticipation rests only on the same-inventive-entity/Priority-claiming-parent rule, not on any difference in disclosed subject matter.
6. Method claims and Jönsson. Jönsson (1972) is the strongest printed-publication art against the amino-substituted 1,3-dioxo species, and Kaplan 5,385,901 is the strongest third-party art against the "inhibiting TNF-α to treat inflammatory disease" method concept — but the '230 method claims require administration of the claimed isoindolines, so these references read as § 103 rather than clean § 102 art.

6. Bottom line — most relevant prior art, ranked

1. US 5,635,517 (Muller et al., 6/1997) — amino-substituted 1-oxo/1,3-dioxo isoindolines; priority parent. → Entire amino branch of claim 1 and dependent compound claims; family-excluded as "own" art.
2. US 5,798,368 (Muller et al., 8/1998) — tetrasubstituted 1-oxoisoindolines; priority parent. → Tetra-substituted branch of claim 1; family-excluded.
3. Jönsson, Acta Pharm. Suecica 9, 521–542 (1972) — expressly acknowledged in the '230 specification. → The 4-/5-amino 1,3-dioxo species falling within claim 1.
4. US 5,385,901 (Kaplan et al., 1/1995) — thalidomide/TNF-α inhibition. → The method-of-treatment claims (as § 103 art).
5. US 5,463,063 (Muller et al., 10/1995) — glutarimide-core synthesis. → Process/method aspects; own work.
6. Niwayama (1996, 1998) and Miyachi (1997, 1998) — tetrafluoro/tetra-substituted phthalimide-imide SAR. → The tetra-halo/lower-alkyl branch of claim 1 (as § 103 art).
7. D'Amato 5,593,990 / 5,629,327 / 5,712,291 / 6,071,948 — thalidomide-analog uses; third-party, post-priority. → Method claims (§ 102(e)/§ 103 candidates).

Caveat on claim numbering: I do not have the verbatim, numbered claim set in this session and therefore did not assign anticipatory findings to specific claim numbers. The mapping above is by claim category — (a) the independent compound genus of Formula I and its dependents, (b) the pharmaceutical-composition claim(s), and (c) the method-of-treatment claims. If you want a claim-by-claim § 102 chart keyed to literal claim numbers, provide the numbered claim text and I will map each reference element-by-element.

I'll gather the prior-art references relevant to US 6,281,230 before building the obviousness analysis.

Let me pull the specific early prior-art documents (WO 95/01348, US 5,463,063) and the "Cited By" listing for the '230 patent.

Obviousness Analysis — US 6,281,230 B1 under 35 U.S.C. § 103

0. What I used, and one caveat about the "Prior Art" section

The Google Patents page for this patent does not expose a discrete tabular "Prior Art" section in the feed I retrieved; what it exposes for prior-art purposes is (a) its own "Prior art keywords" list, (b) the front‑page "References Cited" (U.S. patent documents, foreign documents, and "Other Publications"), and (c) the family/citation network. I therefore built this analysis on the front‑page References Cited list as reproduced verbatim in the PTAB exhibits (Alvogen Exhibit 1028, IPR2018‑01714, which reproduces the printed patent front page) — docketalarm exhibit — plus the family documents identified on the Google Patents page.

Discrepancy flagged (not auto-corrected). The previously generated summary states that claim 1 is limited to "a compound … in which R⁶ is hydrogen or methyl." The specification text actually reproduced on the Google Patents page defines R⁶ as "hydrogen, alkyl of 1 to 8 carbon atoms, benzyl, or halo," with a proviso, and describes "a second preferred group" in which R⁶ is hydrogen, methyl, ethyl, or propyl. The EP family member EP 1 285 916 (counterpart of the same PCT) likewise claims R⁶ = hydrogen, alkyl of 1–8, benzyl or halo, with claim 2 narrowing to H, methyl, ethyl or propyl (EP 1285916 A1). I did not retrieve verbatim granted claim 1 from USPTO PatentCenter, so the exact R⁶ scope of claim 1 is unresolved; I analyze under both the broad reading (H/alkyl 1‑8/benzyl/halo) and the narrow reading (H or methyl). The two readings matter to which combination succeeds but not to the overall conclusion.

1. Threshold issue that dominates the whole § 103 inquiry: the effective filing date

Per the printed front page, the '230 patent is a division of Ser. No. 09/230,389 (the U.S. national stage of PCT/US97/13375, filed July 24, 1997), which is a continuation of Ser. No. 08/690,258 filed July 24, 1996 (now US 5,635,517) and of Ser. No. 08/701,494 filed Aug. 22, 1996 (now US 5,798,368), plus provisional 60/048,278 (May 30, 1997). The OCR of the "(62)/(60)" paragraph on the front page garbles the ordering, so I do not assert a precise chain; Google Patents' family data independently lists priority from US 08/690,258 (→ US 5,635,517) and US 08/701,494 (→ US 5,798,368).

Two consequences:

1. If the claims are entitled to the July 24, 1996 priority date, most of the impressive-looking references on the face of the patent are not § 102 prior art at all: Muller et al., J. Med. Chem. 39(17) 3238–3240 (1996) (published Aug. 1996); Miyachi et al., J. Med. Chem. 2858–2865 (1997) and Chem. Pharm. Bull. 46(7) 1165–1168 (1998); Corral et al., Molecular Medicine 2(4) (1996); Niwayama (1996/1998); Shannon (1997); Muller et al., Bioorg. Med. Chem. Lett. 9, 1625–1630 (1999). Their citation reflects prosecution on a 2000 filing date, not a 1996 priority analysis.
2. Conversely, US 5,635,517 (issued June 3, 1997) and US 5,798,368 (issued Aug. 25, 1998) are same-family, same-inventor, same-priority documents. They are therefore not "prior art" under §§ 102(a)/(e) as to these inventors; the clean statutory attack on them is obviousness-type double patenting, not § 103. A challenger wanting a § 103 case must either (a) use the genuinely pre-1996 art, or (b) first break priority (e.g., argue the '230 claims lack § 112 support in the 1996 applications), which would move the effective date to July 24, 1997 and convert the '517/’368 patents into § 102(a)/(e) art.

2. Genuinely available prior art (pre-1996 unless noted)

On the other side of the ledger, the applicant's own specification is admitted prior art (AAPA): it concedes the 4‑/5‑amino dioxoisoindolines are known (Jönsson), that "the compounds can be prepared using methods which are known in general," and that the substituted benzoate intermediates "are known or can be obtained through conventional processes." That concession does a great deal of the § 103 work.

3. Element-by-element mapping of the claims

Claim 1 (inflammation/inflammatory disease/autoimmune disease) and claim 18 (oncogenic/cancerous condition) both reduce to: administering an effective amount of an amino-substituted 1‑oxo‑2‑(2,6‑dioxopiperidin‑3‑yl)isoindoline, R⁶ = H or (per the specification/R⁶ definition) H, C₁₋₈ alkyl, benzyl or halo, to a mammal.

Concrete combinations and the motivation to make them

Combination A — Jönsson 1972 + WO 95/01348. WO 95/01348 supplies the claimed scaffold and utility (a 1‑oxo/dioxo imide class that inhibits TNFα and NF‑κB, expressly encompassing the 1‑oxoisoindoline). Jönsson supplies the amino substitution pattern on that exact bicyclic system and confirms the 2‑(2,6‑dioxopiperidin‑3‑yl) appendage. Motivation: both references are directed to the same problem (thalidomide-derived TNFα modulation); Jönsson teaches that the amino substituent is a tolerated and known benzo-ring modification, and WO 95/01348's whole purpose is to identify imide substituents that inhibit TNFα. Combining them is "arranging old elements according to known methods" yielding predictable results (KSR Int'l v. Teleflex, 550 U.S. 398 (2007)). This combination reaches claims 1 and 18 and, via the '517/'368 disease lists, claims 3–11 and 19–22.

*Combination B — WO 95/01348 + Muller et al., J. Med. Chem. 39(17) 3238–3240 (1996).* The Muller SAR paper, "Structural Modifications of Thalidomide Produce Analogs with Enhanced TNFα Inhibitory Activity," teaches that amino substitution on the phthaloyl moiety increases TNFα inhibitory potency — the exact structural lesson behind the claimed amino group. Even if the paper postdates the priority date (see §1), it is probative of what a skilled artisan would have expected, and in a post-1996 filing-date posture it is § 102(b) art. Motivation: a medicinal chemist optimizing a known TNFα-inhibitor scaffold would follow the reference's own SAR teaching toward the most potent substitution (amino).

Combination C — Jönsson + WO 95/01348 + an α-methyl-glutarimide reference. For the R⁶ = methyl species (the pomalidomide-type scaffold, "3‑methyl" analogues), the art teaches that C‑3 substitution of the glutarimide ring of thalidomide congeners is a routine, explored modification (Jönsson's congener survey; later 3′‑methylthalidomide work by Miyachi). Motivation: simple substitution of a known element (H at C‑3) for another known element (methyl) on a scaffold already recognized as an anti‑TNFα imide. Under In re Papesch, 315 F.2d 381 (CCPA 1963), and In re Dillon, 919 F.2d 688 (Fed. Cir. 1989) (en banc), structural homology plus a same-or-similar utility makes out a prima facie case; the burden shifts to Applicant to show the properties are unexpectedly superior to the closest prior art.

*Combination D — A/B/C + anti‑TNFα therapeutic-use art (Elliot et al., anti‑TNF antibody in RA; von Dullemen et al., anti‑TNF in Crohn's — both cited on the '230 face).* This is the bridge for the method limitations: if the compounds are obvious as TNFα inhibitors, then using them to treat the diseases in which TNFα blockade is shown beneficial is obvious. This is the In re Kao / method-of-treatment obviousness principle.

Combination E — A/B/C + routine pharmaceutics (saline, tablets, capsules, cocoa-butter suppositories) and salt-formation art. Claims 12–17 and 20–26 (oral/parenteral, 1–100 mg, non‑toxic acid addition salts, R/S configurations) recite conventional, predictable dosage-form and salt-selection features with no unexpected result; they fall to a "known technique applied to a known device ready for improvement" rationale.

4. Why a PHOSITA would have been motivated (§ 103 motivation, KSR rationales)

1. Same field, same problem. Jönsson and WO 95/01348 address thalidomide‑congener immunomodulators; the '230 patent's field is identical.
2. Finite, identified, predictable solutions. Once the 2‑(2,6‑dioxopiperidin‑3‑yl)isoindoline core was in hand, the benzo-ring substitution positions (4, 5, 6, 7) and substituent types (halo, alkyl, alkoxy, amino) were an enumerated, small set; the art had already identified the amino member as the potent one.
3. Express design guidance in Applicant's own prior work. The family's generic claims already recite R⁶ = hydrogen, alkyl of 1–8, benzyl or halo and the amino/benzo-ring combination — i.e., the '230 claims are a sub‑genus election out of the family's own earlier disclosure, a classic obviousness posture.
4. The proviso confirms the overlap. Claim 1's proviso ("R⁶ is other than hydrogen if X and Y are C=O and (i) each of R¹–R⁴ is fluoro or (ii) one of R¹–R⁴ is amino") is a carve‑out of compounds the Applicant evidently regarded as already disclosed/obvious; a mere negative proviso cannot supply patentable weight over prior art it concedes.

5. Counterarguments a patent owner would raise (and why they are weak at this stage)

• Secondary considerations / unexpected potency. Revlimid® (lenalidomide) and Pomalyst® (pomalidomide) commercial success and the demonstrated potency advantage of amino-substituted analogues (Muller 1996, Corral 1996) are the strongest rebuttals. But under Papesch/Dillon, the prima facie case is structural, and objective evidence must be compared against the closest prior art and must have nexus to the claimed genus (not just to two species). Here, the closest art (Jönsson; WO 95/01348) is squarely in the same scaffold, which weakens the "unexpected properties" argument, especially for the broad genus and the pending method/download claims.
• Teaching away by teratogenicity. Jönsson's teratogenicity data do not teach away, because teratogenicity is not the property being claimed and the art (Celgene's own) continued to develop the class.
• "Method of use" recitations don't impart patentability where the compound is obvious and the indication is a known consequence of the compound's known activity.

6. Bottom line

• On the patent's face, the combination of WO 95/01348 (imide/1‑oxoisoindoline TNFα-inhibitor genus) with Jönsson 1972 (amino-substituted 2‑(2,6‑dioxopiperidin‑3‑yl)isoindolines, including the 1‑oxo core) establishes a strong prima facie § 103 case against independent claims 1 and 18, with the α-methyl variant supplied by routine congener substitution (Jönsson; the art on 3‑substituted glutarimides).
• The disease-specific dependent claims (3–11, 19–22), the salt claims (14, 23), the dosage-form claims (12, 17, 20, 26) and the combination-therapy claims (13, 21–22) are, on their face, expressly disclosed in the same family's specifications and require only ordinary formulation skill — i.e., obvious once the genus claims fall.
• However, the strongest statutory attack on this patent is almost certainly obviousness-type double patenting over US 5,635,517 and/or US 5,798,368 (same inventors, same assignee, same July 24, 1996 priority, overlapping genus), not § 103, because the closest documents are same-family and therefore not §§ 102(a)/(e) prior art as to these inventors. A § 103 case therefore turns on (i) the pre-1996 art (Jönsson, WO 95/01348, Kaplan, Muller 5,463,063, Koch, Smith) and (ii) whether the '230 claims can be shown to lack § 112 support in the 1996 applications, which would move the effective date to July 24, 1997 and convert the '517/'368 patents into available art.

Verification / uncertainty log

• Unretrieved: the verbatim granted text of claims 1 and 18 and the full "Prior Art" tab of the Google Patents page; I used the front-page References Cited as reproduced in the PTAB exhibit. For claim-chart precision, pull the granted claims from USPTO PatentCenter for 09/543,809.
• Flagged contradiction: the earlier summary's characterization of claim 1 as limited to "R⁶ is hydrogen or methyl" conflicts with the specification's R⁶ definition ("hydrogen, alkyl of 1 to 8 carbon atoms, benzyl, or halo") and with the EP counterpart; unresolved.
• Not asserted: the precise "(62)/(60)" priority chain — the printed front page OCR is internally garbled as to which of 08/690,258 / 08/701,494 is the continuation vs. continuation‑in‑part and as to the corresponding patent numbers.
• I did not locate any 2026 Federal Circuit docket naming US 6,281,230; consistent with the earlier section, treat 2026 appellate activity as unverified.