US 7230012

I'll research this patent. Let me run some targeted searches.

Let me check litigation/docket history and verify the claim set.

US Patent 7,230,012 — Summary

Note on sources/limits: I could not directly query USPTO PatentCenter or the Federal Circuit's live docket system. The findings below are grounded in the authoritative full text you supplied (Google Patents, fetched 2026‑10‑01) plus secondary sources (DrugPatentWatch, Justia Patents, CourtListener filings). I flag uncertainty explicitly where it exists.

Bibliographic data

Claim count: 10 claims total, of which claims 1, 5, and 7 are independent (claims 2–4 depend from 1; claim 6 from 5; claims 8–10 from 7).

Abstract (as published)

"Pharmaceutical compositions and single unit dosage forms of thalidomide and pharmaceutically acceptable prodrugs, salts, solvates, hydrates, or clathrates are disclosed. Also disclosed are methods of treating and preventing diseases and conditions such as, but not limited to, leprosy, chronic graft‑vs‑host disease, rheumatoid arthritis, sarcoidosis, an inflammatory condition, inflammatory bowel disease, and cancer using the novel dosage forms disclosed herein."

(The related '267 patent's abstract uses "stereoisomers, prodrugs, salts, solvates, hydrates, or clathrates" and "treating, managing, and preventing." The '012 abstract as originally published omits "stereoisomers" and "managing" — I note this literally rather than normalizing it.)

Plain‑language overview of the independent claims

Independent claims are all single‑unit oral dosage forms (capsules) defined by fixed drug load, excipient type/amount, capsule size, and fill weight. This is a formulation/dosage‑form patent (not a compound patent), even though at least one litigant complaint characterized '012 as Celgene's "Composition of Matter" Orange Book listing for THALOMID.

• Claim 1 — A single unit dosage form that is a size 4 capsule containing a uniform admixture of 50 mg thalidomide + 74 mg pregelatinized corn starch. In plain terms: the low‑strength 50 mg capsule, where the starch is the only named non‑active component and the two are intimately mixed.
• Claim 5 — A single unit dosage form that is a size 2 capsule, with contents weighing 250 mg, comprising 100 mg thalidomide and pregelatinized corn starch. Plain terms: the 100 mg strength capsule, defined by capsule size and total fill weight rather than by an exact starch quantity.
• Claim 7 — A single unit dosage form that is a size 0 capsule containing a uniform admixture of 200 mg thalidomide + 297.5 mg pregelatinized corn starch. Plain terms: the 200 mg strength capsule with a specific starch load.

The dependent claims add a lubricant: magnesium stearate generally (claims 2, 6, 8), and specific amounts — 1 mg for the 50 mg/size‑4 form (claim 3), 2.5 mg for the 200 mg/size‑0 form (claim 9) — plus total fill weights of 125 mg (claim 4) and 500 mg (claim 10).

So the three asserted/claimed commercial embodiments map to THALOMID's marketed 50 mg, 100 mg, and 200 mg capsules. Note that no claim recites a method of treatment or a "150 mg" strength, despite the specification/related filings discussing about 25, 50, 100, 150, or 200 mg dosage strengths.

Specification highlights (context for the claims)

• Examples give batch and unit formulations: Example 1, 200 mg thalidomide, 40 wt%, size #0 capsule, 500 mg fill; Example 2, 100 mg tablet (microcrystalline cellulose, croscarmellose sodium, Pluronic F‑68®, magnesium stearate); Example 3 is expressly labeled "Prior Art Thalidomide Dosage Unit" — a 50 mg unit (12.5 wt%) in a size #0 capsule using microcrystalline cellulose, KOLLIDON 90F, stearic acid, colloidal silicon dioxide, crospovidone, and anhydrous lactose.
• The disclosure emphasizes lactose‑free compositions/dosage forms, particularly where the active ingredient is a primary or secondary amine; preferred lactose‑free forms comprise active ingredient, microcrystalline cellulose, pre‑gelatinized starch, and magnesium stearate.
• Manufacturing detail stated: pregelatinized corn starch (SPRESS B‑820) and thalidomide passed through a 710 µm screen and blended; magnesium stearate passed through a 210 µm screen and added last; encapsulated in a size #0 capsule at 500 mg/capsule using a Dosator‑type filler.

Litigation / docket context (as found)

Google Patents' litigation panel cites four D.N.J. cases for this family:

• 2:18‑cv‑13477 (Celgene v. Hikma Pharmaceuticals International Ltd. — filed 2018‑08‑31, terminated 2019‑09‑18)
• 2:15‑cv‑00697 (Lannett)
• 2:07‑cv‑04050 (Barr)
• 2:07‑cv‑00286 (Barr)

Additional context from court/SEC filings: the '012 patent was among 17 Orange Book‑listed THALOMID patents that Lannett certified against in its 2014 Paragraph IV notice (Lannett sought 50/100/150/200 mg generics); the '012 patent also appears in the In re Revlimid & Thalomid Purchaser Antitrust Litigation (D.N.J. 2:19‑cv‑07532) and related antitrust suits (e.g., D. Minn. 0:20‑cv‑00686), and in connection with a 2017 Lannett license to sell generic thalidomide in the U.S. beginning 2019.

Regarding "CAFC 2026 dockets": I found no Federal Circuit docket, opinion, or 2026 proceeding specifically identifying US 7,230,012. Given the patent's adjusted expiration of 2023‑12‑09 (expired lifetime), an active 2026 Federal Circuit appeal specifically naming '012 would be unusual. I do not have authoritative confirmation either way, and my searches for a Federal Circuit appeal returned nothing. Treat "no 2026 CAFC docket located" as a negative search result, not as proof none exists.

Uncertainty / caveats

• Inventor names and the application number (10/608,077) are consistent across the Google Patents record and secondary sources; however, Google Patents and the '267 patent text both render the provisional number as "60426,016" / "No. 60/426,016" — I report it as it appears, not auto‑corrected.
• Secondary aggregators list the '012 patent owner as "Bristol‑Myers" / "Bristol‑Myers Squibb Co." for THALOMID. That reflects post‑Celgene‑acquisition ownership of the product (Celgene was acquired by Bristol Myers Squibb); the patent record itself lists Celgene Corporation as assignee. I flag this as a product‑ownership attribution, not a patent assignment.
• I did not independently verify the maintenance‑fee history; DrugPatentWatch cites a 12th‑year large‑entity fee payment on 2018‑12‑12, consistent with the patent surviving to its 2023 expiration.

I'll search for litigation involving US patent 7230012, starting with the case numbers already referenced in the patent record.

Let me get more specifics on the cases that specifically assert the '012 patent, plus the Lannett and 2018 cases.

Summary of findings

US Patent 7,230,012 ("Pharmaceutical compositions and dosage forms of thalidomide," Celgene Corp., filed 2003‑06‑30, issued 2007‑06‑12, priority 2002‑11‑14) does have known litigation. The Google Patents record for this patent itself flags four U.S. District Court (D.N.J.) cases, plus a Darts‑IP "first worldwide family litigation" entry. Below is what I could verify, with the important caveat that Google Patents' litigation block is family‑level and does not necessarily mean every listed case asserted the '012 patent specifically.

Litigation listed on the US 7,230,012 record

What is confirmed about the '012-specific case

• 2:07‑cv‑04050 (Celgene v. Barr Laboratories, Inc. et al.), filed 2007‑08‑23, D.N.J. is the case that squarely asserted U.S. 7,230,012. As reported at the time: "Infringement of U.S. Patent No. 7,230,012 ('Pharmaceutical Compositions and Dosage Forms of Thalidomide,' issued June 12, 2007) following an amendment of Barr's ANDA to manufacture a generic version of Celgene's Thalomid® … to include a paragraph IV certification of the '012 patent" (patentdocs.org Court Report; Docket Alarm).
• Outcome: The '012 case was resolved by the stipulated dismissal of May 21, 2010 entered in the lead consolidated action 2:07‑cv‑00286‑SDW‑MCA. Under that stipulation, "all claims and counterclaims asserted by Plaintiffs against Barr in this Civil Action No. 07‑286, as well as Civil Action Nos. 07‑4050, 07‑5458 and 08‑3357 consolidated therewith, are dismissed without prejudice"; Barr's federal antitrust and New Jersey‑law counterclaims (Counts XX, XXI, XXII) were dismissed with prejudice (Exhibit 1042, IPR2015‑01103; the same stipulation is Exhibit 1042 in IPR2015‑01096). Docket records show 2:07‑cv‑00286 terminated 2010‑05‑26.
• 2:07‑cv‑00286, also captioned Celgene v. Barr, was filed 2007‑01‑18 and pled the distribution/REMS patents (the '501, '720, '976, '977, '784, '399 and '018 patents on safe distribution of Thalomid), not the '012 composition patent. It is on the '012 page because the '012 action was consolidated into it.

Related but separate Celgene thalidomide/Revlimid litigation (not '012‑specific)

These appear repeatedly in the record and are relevant context, but the sources I retrieved do not show U.S. 7,230,012 among the patents asserted:

• Mylan Pharmaceuticals, Inc. v. Celgene Corp., No. 2:14‑cv‑02094 (D.N.J., filed 2014‑04‑03) — antitrust/sample‑refusal claims; Celgene's motion to dismiss denied 2014‑12‑22; Third Circuit interlocutory appeal denied 2015‑03‑05.
• In re Thalomid and Revlimid Antitrust Litigation, Civil No. 14‑6997 (MCA)(MAH) (D.N.J.) — purchaser class action.
• Celgene v. Natco Pharma Ltd., No. 2:10‑cv‑05197 (D.N.J.) — lenalidomide.
• Celgene v. Dr. Reddy's Laboratories, Nos. 2:16‑cv‑07704, 2:17‑cv‑05314, 2:18‑cv‑06378 (D.N.J.) — lenalidomide.
• The CFAD (Coalition for Affordable Drugs) IPRs (e.g., IPR2015‑01092, ‑01096, ‑01103) challenged REMS patents such as the '501 and '720 — not the '012.

Caveats and rate of confidence

• High confidence: the existence, court, case numbers, filing dates and the Barr dismissal terms for 2:07‑cv‑00286 and 2:07‑cv‑04050, and the listing of 2:15‑cv‑00697 and 2:18‑cv‑13477 on the '012 record.
• Not established: the plaintiff/defendant identities, asserted claims, and outcome for 2:18‑cv‑13477, and the outcome for 2:15‑cv‑00697. I did not locate a docket entry or termination order for either in the material retrieved, and I will not guess at the parties. Note also that the Google Patents litigation block links a Darts‑IP family (No. 32326306) for "first worldwide family litigation," which may include foreign proceedings that I could not enumerate.
• I found no Court of Appeals for the Federal Circuit decision specifically addressed to U.S. 7,230,012; the appeals referenced in this family concern other Celgene patents (e.g., the '501/'720 S.T.E.P.S. patents reaching the Supreme Court in Celgene Corp. v. Peter, No. 19‑1074).
• No reexamination, IPR, or PGR of U.S. 7,230,012 itself appears in the retrieved material; the patent is recorded as Expired – Lifetime, adjusted expiration 2023‑12‑09.

If you want, I can try to pull the PACER/CourtListener dockets for 2:15‑cv‑00697 and 2:18‑cv‑13477 to fill in the missing party and outcome fields.

I'll start by checking the structured data (no AIA trials indexed) against the public record via web search.

No IPR hits yet on the patent itself. Let me search PTAB-specific and litigation-specific sources.

Let me check patent-specific PTAB trackers and any Hikma/Unified filings.

Proceedings overview

Total AIA trial proceedings on US 7,230,012 ("the '012 patent") on file: zero — the USPTO Open Data Portal structured block reports no IPR, PGR, or CBM for this patent, and my independent web checks (Google Patents family/litigation data, PTAB-adjacent dockets, Celgene/BMS SEC disclosures, DrugPatentWatch patent-level litigation/PTAB pages) surfaced no petition, institution decision, or Final Written Decision naming the '012 patent. Bottom-line defensive posture: this is not a "hardened by IPR" patent, and it is not a "claims canceled" patent either — it is an untested patent that has already expired (adjusted expiration 2023-12-09, status "Expired – Lifetime" per the ODP/Google Patents record). That means no PTAB estoppel applies to anyone, but it also means any present-day demand letter can, at most, reach pre-expiration conduct inside the 35 U.S.C. § 286 six-year damages lookback — the patent itself no longer gives its owner a forward-looking exclusionary right.

Verification caveat: I was unable to complete an exhaustive PTAB E2E / Patent Center docket sweep of every petition number before my search budget was exhausted. The ODP structured block is the canonical source and shows none; confirm at PTAB E2E (and cross-check the family litigation tab at Google Patents US7230012) before relying on the "zero" count in a brief.

Proceedings on this patent

There are no AIA trial proceedings to report for US 7,230,012. No proceeding numbers are invented here, because none exist on the public record I could reach.

For completeness on why the number is zero by design, this patent is pre-AIA (filed 2003-06-30, granted 2007-06-12), so:

• Post-Grant Review was never available — PGR applies only to patents with an effective filing date on or after 2012-03-16.
• Covered Business Method review was never available — CBM was confined to financial-services/data-processing claims, and the '012 claims are pharmaceutical dosage forms.
• IPR was the only AIA vehicle ever available (35 U.S.C. § 311(c) window opened nine months after issuance, i.e., ~2008-03-12). No one used it.

The Celgene IPRs you may be confusing with this patent — not on the '012

Practitioners searching "Celgene + thalidomide + IPR" will land on the S.T.E.P.S./REMS distribution-method patents. Those decisions say nothing about the '012, and should not be cited as if they did:

• Coalition for Affordable Drugs VI LLC v. Celgene Corp., IPR2015-01092 — challenged all ten claims of U.S. 6,045,501 (not the '012). Instituted 2015-10-27 (Paper 20); FWD 2016-10-26 (Paper 73) held claims 1–10 unpatentable as obvious over Powell, Mitchell, and Dishman. (Sourced from the cert-petition appendix, Celgene Corp. v. Peter, S. Ct. No. 19-1074, supremecourt.gov docket PDF.)
• Three further CFAD IPRs on U.S. 6,315,720 (all 32 claims; all instituted; rehearing left only claim 10 patentable); and a later set of Celgene IPRs on other Celgene distribution patents (the "788, '536, '229" patents instituted 2017-10-10, per Celgene's 10-K disclosures).
• Appeal: Celgene appealed; Celgene Corp. v. Peter, Nos. 2018-1167 & 2018-1171 (Fed. Cir. July 30, 2019) affirmed the Board's obviousness holdings, rejected Celgene's Fifth Amendment takings challenge to retroactive IPR of pre-AIA patents, and denied cert (S. Ct. No. 19-1074).

Defensive value of the above for an '012 defendant: none. Different patent numbers, different claims (distribution methodology vs. capsule formulations), no estoppel effect. Cite them only as background on the patent owner's litigation posture.

District-court activity on the '012 (context, not PTAB)

The '012 was a litigated formulation patent, never a PTAB-tested one. Per the family-litigation links in the patent record and Celgene's own SEC filings:

• NJD 2:07-cv-00286 and NJD 2:07-cv-04050 (2007 Barr thalidomide ANDA actions; the '012 was asserted in the August 23, 2007 complaint after Barr's supplemental Paragraph IV certification).
• NJD 2:15-cv-00697 (per family litigation links).
• Celgene Corp. v. Hikma Pharmaceuticals International Ltd., NJD 2:18-cv-13477 — filed 2018-08-31, terminated 2019-09-18, asserting the '012 alongside '720, '977, '784, '399, '018, '566, '886 and '531 (see DrugPatentWatch docket summary and Unified Patents litigation portal). Resolution terms are not public in the sources I reviewed — do not assume a settlement on stated terms.
• Purchaser-side antitrust actions in D. Minn., D.D.C., and D.N.J. (e.g., the consolidated Revlimid/Thalomid purchaser antitrust litigation) alleged that the '012 and sibling patents were procured and asserted improperly. Those are allegations and pleadings, not invalidity holdings, and no court invalidated the '012 in any decision I could locate.

Strategic summary

Claim status. There is no PTAB cancellation record, so on the PTAB axis every claim of the '012 stands as issued. The ten claims are three independent single-unit dosage-form claims (claim 1: size 4 capsule, 50 mg thalidomide + 74 mg pregelatinized corn starch; claim 5: size 2 capsule, 250 mg fill, 100 mg thalidomide + pregelatinized corn starch; claim 7: size 0 capsule, 200 mg thalidomide + 297.5 mg pregelatinized corn starch), with dependents 2–4, 6, and 8–10 adding magnesium stearate and fill-weight limits. So the accurate one-line status is: claims 1–10 all UNTESTED at the PTAB; none canceled; none sustained (nothing was ever adjudicated). The decisive fact is not claim status but term: adjusted expiration 2023-12-09, marked "Expired – Lifetime" in the ODP record. On 2026-10-01 the '012 cannot be infringed prospectively.

Estoppel landscape. Because no IPR was ever filed, § 315(e)(2) estoppel is empty — no petitioner, no privy, no ground is barred. That cuts both ways but is now largely academic: with the patent expired, an IPR petition would have negligible practical value (no forward injunction to defeat), though the PTAB has in principle instituted on expired patents under Phillips claim construction. If a lawsuit asserting the '012 is filed today, the real battleground is § 286 damages: recovery is limited to infringement occurring within six years before the complaint. Suit filed 2026-10-01 reaches back only to 2020-10-01, and the actionable window closes at expiration (2023-12-09). Invalidity, inequitable conduct, and prosecution-laches-type defenses remain fully available to an accused past infringer, unconstrained by any IPR estoppel.

Pattern signals. (1) The '012 itself attracted no IPR filer over a ~16-year post-issuance window — unusual for a listed composition-of-matter Orange Book patent, and consistent with accused generics preferring the ANDA/§ 271(e)(2) route and settlements. (2) Celgene's aggressive PTAB history runs through a hedge-fund-funded petitioner, Coalition for Affordable Drugs VI LLC (Kyle Bass / Erich Spangenberg), against the REMS patents — not through any defensive aggregator, and not against the '012. (3) On the patent-owner side, Celgene appealed REMS IPR losses to the Federal Circuit and then to the Supreme Court (cert denied), showing it litigates adverse PTAB outcomes hard — but there is no '012 PTAB appeal because there is no '012 PTAB proceeding. (4) Celgene's thalidomide family was monetized mainly through serial ANDA suits and settlements rather than through PTAB adjudication.

Recommended next steps

1. Do not brief the '012 as IPR-hardened or IPR-invalidated. The correct representation to a court or adversary is: "There are no AIA trial proceedings involving US 7,230,012 (USPTO ODP, verified 2026-10-01)." Anchor that on the ODP/Google Patents record and confirm at PTAB E2E by searching the patent number directly.
2. Lead with expiration, not invalidity. The patent's adjusted expiration is 2023-12-09 with status "Expired – Lifetime." Any demand letter asserting ongoing infringement is facially defective. If you face a demand for past sales, compute the § 286 window against the complaint date (e.g., a complaint filed 2026-10-01 reaches only back to 2020-10-01) and demand the plaintiff's pre-suit notice and damages-accrual theory.
3. Preserve invalidity and enforceability defenses. With no IPR estoppel in play, prior-art and inequitable-conduct defenses are unconstrained. The district-court antitrust complaints (CourtListener, D.N.J.) contain extensive prior-art and disclosure allegations about Celgene's thalidomide family, including the '012 — useful as a research lead, but treat every assertion in them as an unproven allegation.
4. If you are within a live ANDA/§ 271(e)(2) posture involving a still-asserted sibling patent (e.g., the '886 or another listed patent), note that the '012 is expired and cannot support a 30-month-stay predicate going forward — check the current Orange Book listing and BMS's patent-by-patent position rather than relying on the 2007–2019 litigation record.
5. Re-verify before filing. My sweep was cut short by tooling limits; if this analysis will support an IPR, a motion, or an opinion letter, pull the complete PTAB E2E docket history for US 7,230,012 and confirm the "no proceedings" finding in a dated declaration or search log.

I'll research this patent's ownership chain. Let me start with the assignment records and related sources.

US 7,230,012 B2 — Ownership Chain Reconstruction

Data limitation up front: In this session I was able to retrieve Google Patents legal-event data (embedded in the authoritative record supplied) and litigation/SEC context via search, but I was not able to open the USPTO Assignment Center record directly, and no reel/frame numbers appear in any source I could retrieve for this patent. I therefore report the two recorded assignments that are documented in the Google Patents legal events, and I explicitly decline to invent reel/frame identifiers. Where the record is silent, I say so.

Inventors

• Both inventors are named on application 10/608,077, filed 2003-06-30, claiming priority to 2002-11-14, issued 2007-06-12.
• Both assigned their rights to Celgene Corporation; D'Angio's assignment was recorded first (2004-02-18), with McCarty's following (2004-03-24). This is the ordinary inventor-to-employer sequence — no gap, no withheld inventor.
• Unusual-pattern check: not present. There is no evidence of the inventors departing Celgene around filing, and neither name recurs as an assignor to a third party in any source I retrieved. Note the inventors are formulation/packaging personnel rather than the medicinal-chemistry group (e.g., Zeldis, Muller, Williams) that populates Celgene's other Thalomid/Revlimid patents — relevant only as a characterization of the patent family, not as an ownership signal.

Original assignee

Celgene Corporation (Summit, NJ; later 86 Morris Ave., Summit, NJ) — the entity named on the issued patent.

• Product embodying the claims: Yes. The '012 patent is Celgene's composition/dosage-form patent listed in the FDA Orange Book for THALOMID (thalidomide; NDA 020785). Multiple complaints quote Celgene's own "patent protection web" chart listing the '012 patent as the Composition of Matter patent for Thalomid, filed 30-Jun-03, issued 12-Jun-07, expiring 9-Dec-23. See, e.g., the Celgene antitrust complaints reproduced at courtlistener.com (N.D. Ill./D.N.J. filings) and the Hagens Berman amended complaint (hbsslaw.com).
• Primary line of business: Branded biopharmaceuticals (thalidomide, lenalidomide/Revlimid, pomalidomide/Pomalyst). Celgene commercialized Thalomid itself and enforced the '012 patent through Hatch-Waxman ANDA litigation.
• Current status: Acquired. Bristol-Myers Squibb Company acquired Celgene effective 2019-11-20 (Celgene became a BMS subsidiary; the deal closed November 2019). Celgene was not in bankruptcy and was not dissolved. A footnote in a later Orange Book table (hbsslaw.com filing) lists the Thalomid patent owner as "Bristol-myers," consistent with post-merger succession, but I found no recorded assignment document for the '012 patent in the sources I retrieved.

Assignment timeline

Only two recorded assignments are documented in the legal events available to me. Both are inventor→employer; neither is a transfer away from Celgene.

• 2004-02-18 (executed) / recorded 2004-02-18 — Reel N/A — not retrieved

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: Paul D'Angio
  • Assignee: Celgene Corporation
  • Correspondent: not available in retrieved text. Note that the prosecution attorney/agent of record for the patent is Jones Day (per the Justia patent-history record for 7,230,012). No recurrence can be assessed because only one other entry exists in this chain.
  • Context: Routine inventor assignment to employer — no consideration to a third party, no change in beneficial ownership.

• 2004-03-24 (executed) / recorded 2004-03-24 — Reel N/A — not retrieved

  • Conveyance: Assignment of Assignors' Interest
  • Assignors: Paul D'Angio; John McCarty
  • Assignee: Celgene Corporation
  • Correspondent: not available in retrieved text.
  • Context: Routine inventor assignment to employer (confirmatory/补充 filing completing the chain of title to Celgene).

No post-issuance assignment is recorded in the sources I could retrieve. No security agreement, no merger recording, no license recordal, no transfer to any LLC, and no release appears. If the 2019 BMS merger generated a recorded assignment for this patent, it did not surface in the legal-event data available to me — treat that as an open item to confirm at the Assignment Center, not as a finding.

Stopping condition check: the Assignment Center was not directly queried in this session, so I cannot state affirmatively that "no records exist." What I can state affirmatively is that the only recorded transactions surfaced are the two 2004 inventor assignments, both to Celgene.

Timeline diagram

timeline
    title Ownership of US 7230012
    2002 : Priority application filed by Celgene inventors
    2003 : Utility application 10 608 077 filed
    2004 : D'Angio assigns rights to Celgene
         : McCarty assigns rights to Celgene
    2007 : Patent issues to Celgene Corporation
         : Celgene sues Barr over generic Thalomid
    2015 : Celgene sues Lannett over generic Thalomid
    2019 : Bristol Myers Squibb acquires Celgene
    2023 : Patent expires

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only recorded assignee is Celgene Corporation, an operating brand manufacturer, per the 2004-02-18 and 2004-03-24 entries. No "IP / Holdings / Licensing / Ventures" successor appears anywhere in the retrieved record, and no single-purpose LLC is a party.

2. Known asserter in the chain — not present. Neither Celgene Corporation nor any successor appears on the RPX/Unified high-frequency-plaintiff directories or on the enumerated NPE list (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Erich Spangenberg entities). The litigation asserted by this patent is Celgene v. Barr (D.N.J. 2:07-cv-00286 and 2:07-cv-04050) and Celgene v. Lannett (D.N.J. 2:15-cv-00697) — brand-versus-ANDA-filer suits, the opposite of an NPE posture. The 2:18-cv-13477 New Jersey case in the Google Patents litigation panel is likewise consistent with Celgene's generic-defense campaign.

3. Repeat correspondent across the chain — not present / cannot be assessed. There is no chain to test for recurrence: the file contains at most two assignments and both have the same single assignee. Prosecution counsel of record is Jones Day, a general-practice firm that handles both operating-company and, occasionally, assertion-side work — a single-firm appearance in a two-entry chain carries no diagnostic weight under the recurrence rule. I have no correspondent-of-record names for the recorded assignments and will not fabricate them.

4. Cascading transfers — not present. No consecutive assignments through chained entities exist; the most recent transfer in the retrieved record is dated 2004, nearly two decades before expiry.

5. Pre-litigation transfer — not present. The first infringement suit naming this patent (Celgene v. Barr, filed January 2007) post-dates the only assignments (February/March 2004) by roughly three years, and those assignments ran to the plaintiff, not to a litigation vehicle. There is no within-6-months transfer.

6. Bankruptcy fire-sale — not present. Celgene never filed Chapter 7 or 11. Celgene was acquired by Bristol-Myers Squibb in a $74 billion all-stock merger that closed 2019-11-20 (see the Celgene Corp. SEC EX-4.2 Assignment, Assumption and Amendment Agreement dated 2019-11-20, filed 2020-05-05, per Law Insider's contract index). That is a solvent merger, not a fire-sale. No Kodak/Nortel/Polaroid-style asset auction is involved.

7. Privateering — not present. This is the inverse case: Celgene kept the patent in-house and asserted it directly against competitors (Barr, Lannett, and in the broader campaign Natco, Lotus, Zydus, Cipla, Sun, Apotex, Hetero, Mylan). No operating company transferred the patent to an NPE to assert on its behalf; Celgene is the plaintiff of record in every retrieved case.

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates at Celgene (now within Bristol-Myers Squibb), an active enforcer. The patent is therefore not neutralized; it expired on its own terms.

Additional note on the litigation posture: the '012 patent is the subject of substantial antitrust exposure for the patentee, not NPE-style assertion. Third-party complaints (retailer/insurer opt-out actions in D.N.J.; the Cigna action, 1:25-cv-05237) allege Celgene used its Thalomid/Revlimid "patent fortress," REMS abuse, citizen petitions, and reverse-payment settlements to maintain monopoly. That context reinforces a characterization of the owner as an aggressive brand enforcer — legally contentious, but categorically not an NPE.

Verdict

Operating-company assertion.

Justification: the only recorded assignments (executed and recorded 2004-02-18 for D'Angio; 2004-03-24 for D'Angio and McCarty) convey the inventors' rights to Celgene Corporation, an operating brand manufacturer that commercialized the claimed subject matter as THALOMID and listed the '012 patent in the Orange Book as a composition-of-matter patent; the patent was asserted directly by Celgene against ANDA filers (Barr, D.N.J. 2:07-cv-00286 / 2:07-cv-04050; Lannett, D.N.J. 2:15-cv-00697), which is the classic operating-company/profile posture. Every NPE signal in the checklist is not present; the only ownership change of consequence is Bristol-Myers Squibb's 2019-11-20 acquisition of Celgene, a solvent merger of two operating pharmaceutical companies. The patent expired 2023-12-09, so the chain is now closed.

Verification links:

• Google Patents legal events: https://patents.google.com/patent/US7230012/en
• USPTO Assignment Center (query by patent number — reel/frame for the 2004 records remains unverified): https://assignmentcenter.uspto.gov/
• Unified Patents litigation portal (D.N.J. cases): https://portal.unifiedpatents.com/litigation/New%20Jersey%20District%20Court/case/2%3A15-cv-00697

Open items I could not close: (a) reel/frame numbers for the two 2004 assignments; (b) the correspondent of record who filed those recordings; (c) whether the 2019 BMS/Celgene merger produced a recorded assignment against this patent number. None of these gaps, if filled, would change the verdict, since every candidate outcome still terminates at Celgene/BMS.

I'll research the prior-art citations for US 7,230,012. Let me run targeted searches.

Let me get the complete front-page reference list and details on the individual cited patents.

I hit my search-step limit before I could pull every individual reference's specification text, so the analysis below is a screening-level § 102 assessment built on the reference list I did retrieve plus the family's EP search report. I flag confidence levels explicitly.

Prior art for US 7,230,012 B2

0. Source and method caveats (read first)

• Per the strict rule, I interpret identifiers literally and do not auto-correct them. Anything that looks like a typo in the record is reported as it appears.
• USPTO PatentCenter could not be queried directly in this session. The reference list below was obtained from the Justia Patents "Referenced Cited" panel for patent number 7230012 (Justia mirrors USPTO front-page data), and cross-checked against the reference list printed on the front page of the family member US 9,006,267 B2 (continuation-in-part of 10/608,077).
• Important gap: the authoritative full text you supplied (Google Patents, fetched 2026-10-01) does not include a "(56) References Cited" section in the text I was given, and I could not open the issued patent PDF front page. The list below is therefore from a reliable mirror, not the face of the document itself. Treat it as provisional pending front-page confirmation.
• Justia's "Referenced Cited" merges examiner citations and applicant IDS citations; it does not distinguish them. I cannot tell you which were relied on in a rejection.

1. U.S. patent documents cited (per Justia, patent 7230012)

Assessment of the patent set as a whole: references 1–16 are predominantly method-of-treatment and compound/genus patents (D'Amato angiogenesis, Andrulis therapeutic uses, Kaplan). On their face they do not disclose a single unit dosage form defined by capsule shell size plus specific thalidomide and pregelatinized-corn-starch masses. References 17–18 post-date the priority date and can at most be § 102(e) art. I found no cited U.S. patent that anticipates claims 1–10.

2. Non-patent literature cited (per Justia)

Caveat: the Justia snippet I retrieved shows the NPL list extending past the "Thalomid" entries ("Thaildom…"), so the list may be truncated. Confirm the tail of the "(56)" NPL block on the issued front page.

3. References flagged against the family but not on the '012 face — possible omission (verify)

The EPO's search report for the '012-family counterpart EP 2 277 512 A3 (title and abstract match '012 verbatim: "…prodrugs, salts, solvates, hydrates, or clathrates… treating and preventing…") designated three "X" documents against claims 1–13:

1. WO 01/74362 A (Dannenberg, Muller; Celgene Corp.), published 11 October 2001 — flagged X for claims 1–13, citing p. 5 lines 1–6, p. 7–8 ex. 1, p. 9–10 ex. 4.
2. US 2001/0018445 A1 (Huang, Chun-Ying et al.), published 30 August 2001 — flagged X for claims 1–13, citing ¶¶ [0006]–[0008] and p. 2 ex. 1.
3. US 5,731,325 A (Andrulis Jr. et al.) — see ref. 9 above.

This is the single most important discrepancy to resolve. WO 01/74362 (a Celgene application) and US 2001/0018445 A1 do not appear in the Justia "Referenced Cited" panel for US 7,230,012, yet both are X-category (novelty) art dated before the 2002-11-14 priority date and are recited in the '267 patent's reference list. Two possibilities: (a) Justia's panel is incomplete; or (b) they were genuinely not cited on the U.S. face. Either way, WO 01/74362 and US 2001/0018445 A1 are the strongest § 102 candidates in this family and must be pulled and charted element-by-element.

4. Bottom line on anticipation

1. No cited U.S. patent anticipates claims 1–10. The claims are narrowly drawn to dosage forms defined by capsule shell size (size 4, size 2, size 0), specific active loads (50 mg, 100 mg, 200 mg thalidomide), specific pregelatinized corn starch loads (74 mg; 297.5 mg), fill weights (125 mg, 250 mg, 500 mg), and magnesium stearate amounts (1 mg, 2.5 mg). The D'Amato and Andrulis patents are method/compound disclosures; a generic statement that thalidomide "may be administered in capsule form" cannot anticipate a species so defined.
2. The three genuine § 102 threats are: US 5,731,325 (Andrulis), WO 01/74362 (Celgene), and US 2001/0018445 A1 (Huang) — all X-rated against the EP counterpart's claims 1–13 — plus the THALOMID PDR entries for 50 mg capsule disclosure. None has been shown here to recite the numerical capsule/excipient parameters, so on the present record they support at most a § 103 combination, not anticipation.
3. The specification undercuts its own novelty margin: Example 3 is expressly captioned "Prior Art Thalidomide Dosage Unit" — a 50 mg unit (12.5 wt%) in a size #0 capsule with microcrystalline cellulose, KOLLIDON 90F, stearic acid, colloidal silicon dioxide, crospovidone, and anhydrous lactose. That is an applicant admission that a 50 mg thalidomide capsule was prior art. Claim 1 escapes it only via the size 4 shell and the 74 mg pregelatinized corn starch limitation.
4. Unverified items I will not invent: exact filing dates for each cited patent; the full tail of the NPL list; and the true inventorship of US 6,228,879 (Justia "Green et al." vs. '267 "D'Amato" — unresolved contradiction, reported literally).

Recommended next steps (if you can run them): (i) pull the certified front page of US 7,230,012 from PatentCenter to confirm the (56) list verbatim; (ii) obtain WO 01/74362, US 2001/0018445 A1, and US 5,731,325 and chart them against the size-4/74 mg and size-0/297.5 mg limitations; (iii) confirm § 102(e) filing dates for US 6,914,067 and US 2003/0191098.

I'll research the prior art cited on this patent's face and in the examiner's record.

Let me pull the complete cited-references list and the key non-patent references.

Obviousness Analysis — US 7,230,012 B2 under 35 U.S.C. § 103

Note on sources: this analysis builds on the earlier sections (bibliographic data, claim set, specification highlights, litigation context) and does not repeat them. It is grounded in (i) the authoritative full text you supplied (Google Patents, fetched 2026‑10‑01), (ii) the "References Cited" list of record as reflected in the Justia full‑text page for 7,230,012 and the mirrored prosecution copy at storage.courtlistener.com/recap/gov.uscourts.njd.382839/gov.uscourts.njd.382839.1.0.pdf, and (iii) the parallel list in the continuation US 9,006,267. I could not retrieve an IPR, PGR, or reexamination record specifically naming '012; treat that as a negative search result, not proof none exists. Nor could I verify every page cite of the non‑patent literature (the "OTHER PUBLICATIONS" entries are largely bibliography-only in the sources I could reach). Where a POSA declaration would need the full text of a reference, I say so.

1. The governing framework

Graham v. John Deere Co., 383 U.S. 1 (1966), as refined by KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007): scope and content of the prior art; differences between the prior art and the claims; level of ordinary skill; and secondary considerations. Under KSR, a combination may be obvious where the prior art elements were known, the combination was "obvious to try," the variation was "design choice" or a "predictable use of prior art elements according to their established functions," or where the invention was no more than "a combination of familiar elements according to known methods… yielding no more than predictable results." Routine optimization of a "result‑effective variable" is obvious (In re Applied Materials, 692 F.3d 1289 (Fed. Cir. 2012); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003); In re Aller, 220 F.2d 454 (CCPA 1955)).

Level of ordinary skill (POSA): a pharmaceutical formulator with a B.S. in pharmacy, chemistry, or chemical engineering plus ~2–5 years of solid‑dosage‑form development experience (or an M.S./Pharm.D. with less). The art here — hard‑gelatin capsule fill formulation, diluent/binder selection, lubricant levels, and capsule‑size/fill‑weight matching — is an exceptionally well‑developed, empirical‑then‑routine field, as the patent's own specification concedes by citing general texts (Remington; Carstensen, Drug Stability).

2. The claims, reduced to their operative variables

Mapping claims 1–10 against the specification's Table/Examples yields a pattern that is central to the obviousness case:

Every independent claim is a 40 % w/w thalidomide fill in pregelatinized corn starch, with a conventional magnesium‑stearate lubricant, filled into the standard capsule size whose nominal capacity matches that fill weight. That is not a small point. It means the claims collapse to (a) a fixed drug‑load ratio, (b) a single named diluent/binder, (c) a routine lubricant, and (d) capsule‑size selection dictated by fill volume. Each of those was a matter of ordinary formulation practice, and the patent's own Example 1 (200 mg, 40 wt%, size #0, 500 mg fill) supplies the very ratio the claims recite.

3. The prior art of record and what each reference teaches

Patent references (all cited on the face of '012):

• D'Amato patents — US 5,593,990; 5,620,327; 5,712,291; 6,071,948; 6,114,355; 6,235,756; 6,469,045; and US 2003/0191098 A1. These disclose thalidomide and thalidomide analogues as active agents, their therapeutic uses (angiogenesis inhibition, oncology, inflammatory disease), and effective dose ranges — i.e., they supply the active ingredient, the medical need, and the dose levels (including the 100–200 mg/day range that maps to the 100 mg and 200 mg strengths).
• Andrulis patents — US 5,405,855; 5,434,170; 5,643,915; 5,654,312; 5,731,325; 6,001,828; 6,140,346; US 5,385,901 (Kaplan et al.); US 6,228,879 (Green et al.); US 6,914,067 (Govindarajan et al.). These are thalidomide composition/use and formulation/dispensing art, confirming thalidomide's status as a well‑characterised active with established oral dosing.
• WO 01/74362 and WO 03/080048 (listed in the sibling '267): pharmaceutical formulation/thalidomide‑analogue formulation art.

Non‑patent literature of record (the references that do the § 103 work):

1. "Thalomid," Physician's Desk Reference, 53rd–61st eds. — the commercial thalidomide capsule label(s). Discloses thalidomide capsules, oral administration, the 50 mg strength, dosing, and (in the later editions) the higher strengths.
2. Gennaro, Remington: The Science and Practice of Pharmacy, 19th ed., pp. 1618, 1642–1644 — the standard capsule‑formulation text: hard‑gelatin capsule size numbering and nominal fill capacities, diluents/fillers (including starches and pregelatinized starch), and lubricants such as magnesium stearate at conventional levels (typically ~0.25–2 % w/w).
3. Guo et al., "A prototype intelligent hybrid system for hard gelatin capsule formulation development," Pharmaceutical Technology, pp. 44–60 (Sep. 2002) — squarely on point: a systematic framework for selecting excipients and matching fill weights for hard gelatin capsules.
4. Alebiowu et al., "Effects of natural and pregelatinized sorghum, plantain, and corn starch binders on the compressional characteristics of a paracetamol tablet formulation" — teaches pregelatinized corn starch as a known pharmaceutical binder/diluent with characterised flow and compressional behaviour.
5. Clark et al., "Thalidomid (Thalidomide) Capsules," Drug Safety — a review of thalidomide capsule products.
6. Teo et al., 1999, J. Clin. Pharmacol. 39:1162–1168; Teo et al., 2000, Biopharm. Drug Dispos. 21:33–40; Scheffler et al., 1999, Clin. Pharmacol. Ther. 65:483–490 — thalidomide pharmacokinetics/bioavailability; establish that formulation variables materially affect thalidomide dissolution and plasma levels, supplying a concrete motivation to reformulate and to control fill composition.
7. Baker et al., Haematology Society of Australia and New Zealand, Abstracts (Jul. 2000), 54 — thalidomide 200 mg dosing in relapsed/refractory myeloma: motivation for a 200 mg strength.
8. Carstensen, Drug Stability: Principles & Practice; Remington — lactose/excipient incompatibility and the general principle that reducing reactive excipients improves stability of hydrolytically/reductively labile actives.
9. "Thalidomide," The Merck Index, 11th/12th/13th eds.; Rouhi, Chem. & Eng. News — background characterisation of the active.

Admitted prior art inside the specification itself: Example 3 is expressly headed "Prior Art Thalidomide Dosage Unit" — a 50 mg thalidomide unit (12.5 wt %) in a size #0 capsule with microcrystalline cellulose, KOLLIDON 90F (PVP), stearic acid, colloidal silicon dioxide, crospovidone, and anhydrous lactose. This is a Jepson‑style admission and, under Pente v. Graphic Controls, 776 F.2d 309, 315 (Fed. Cir. 1985), the patentee has admitted the pre‑existing 50 mg thalidomide capsule as prior art.

4. Combinations that render the claims obvious

Combination A (the core combination): Thalomid PDR label (53rd/54th eds.) + Remington (Gennaro) + Teo/Scheffler.

• The PDR label discloses a thalidomide capsule at 50 mg.
• Teo/Scheffler provide the motivation: thalidomide exhibits variable/fast clearance and formulation‑dependent bioavailability, so the skilled formulator is led to control and standardise the fill composition; and the D'Amato/Baker art establishes clinical need for 100 mg and 200 mg strengths.
• Remington supplies the how: choose a capsule size by fill weight; fill with a diluent/binder; add a small amount of magnesium stearate.
• Result: claims 1, 5, 7, and their dependents, at the level of generality needed for a prima facie case. The specific numbers (74 mg starch; 297.5 mg starch; 1 mg/2.5 mg stearate; 125 mg/500 mg fill) are not inventive contributions — they are the arithmetic consequence of a 40 % drug load plus a ≤1 % lubricant inside a size‑4/size‑2/size‑0 shell, which is exactly the result‑effective‑variable situation of In re Applied Materials and In re Aller.

Combination B: Thalomid PDR label + Alebiowu et al. + Remington (the lactose‑free angle).

• The specification's stated raison d'être is a lactose‑free dosage form (to avoid degradation of the API and to avoid the known lactose/reactive‑nitrogen incompatibility).
• The admitted Example 3 prior art uses anhydrous lactose.
• Alebiowu et al. teach pregelatinized corn starch as a substitute diluent/binder with known compactibility; Remington teaches that starches are standard capsule fillers.
• Motivation: eliminate a reactive diluent while retaining a free‑flowing, compressible, cheap filler — a classic substitution of one known excipient for another to achieve its known property (KSR: "predictable use of prior art elements according to their established functions").
• Result: the excipient limitations of claims 1, 5, 7.

Combination C: Admitted prior art (Example 3) + D'Amato patents + Remington + Carstensen.

• Example 3 gives a 50 mg thalidomide capsule (size #0, lactose‑containing) squarely within the claim‑1 genus except for capsule size, fill weight, and the starch/swapping.
• D'Amato patents give the higher doses (100 mg, 200 mg) and the conditions treated.
• Remington + Carstensen make the reformulation routine: reduce capsule size to the minimum that holds the fill, swap lactose for pregelatinized starch, add magnesium stearate.
• Motivation: smaller capsule = better patient compliance/swallowability; lactose‑free = better stability; strengths matched to the labelled dosing regimen.

Combination D: Guo et al. + Thalomid PDR label (+ Remington).

• Guo is the "design‑of‑the‑formulation" roadmap for hard gelatin capsules; combined with the label's disclosure of thalidomide capsules at multiple strengths, it makes the systematic development of exactly the claimed fill weights an "obvious to try" exercise with a reasonable expectation of success — the KSR "finite number of identified, predictable solutions" scenario.
• Result: all claims, including the specific fill weights of claims 4 and 10.

Combination E: WO 01/74362 / WO 03/080048 + Thalomid PDR label + Remington.

• Formulation‑oriented PCT disclosures directed to thalidomide/immunomodulatory compounds in unit dosage forms, combined with the label and standard capsule science, similarly yield the claimed subject matter.

5. Why a POSA would have been motivated to combine (articulated per limitation)

1. Multiple strengths (50/100/200 mg). Thalidomide is dosed across a wide range (ENL, oncology, GVHD); the D'Amato and Baker references and the label establish the therapeutic need for 50, 100 and 200 mg capsules. Providing additional strengths of a marketed drug is a routine, market‑driven step.
2. A defined, reproducible fill. Teo/Scheffler show formulation affects thalidomide pharmacokinetics; a formulator seeking consistent dissolution and content uniformity is led to a fixed, simple diluent matrix and a lubricant — precisely the simple binary/ternary fill claimed.
3. Pregelatinized corn starch. Known, commercially available (e.g., SPRESS B‑820, as the specification itself names), lactose‑free, free‑flowing, self‑lubricating to a degree, and well characterised (Alebiowu). Substituting it for lactose or microcrystalline cellulose achieves its known function.
4. Capsule size and fill weight. Remington and Guo teach the size↔fill‑weight relationship. Given a 40 % drug load and a 125/250/500 mg fill, the size‑4/size‑2/size‑0 selection is a design choice with a predictable outcome, not an inventive step.
5. Magnesium stearate. The most common capsule/tablet lubricant; 0.5–1 % w/w (here 1 mg/125 mg and 2.5 mg/500 mg) is within the conventional range taught by Remington.
6. Reasonable expectation of success. Every element was known to perform its established function; no new chemistry, no unexpected mechanism, no unpredictable biological result. Under KSR, that is sufficient.

6. Secondary considerations — and why they likely fail to rescue the claims

• Unexpected results: essentially absent from the specification. The '012 disclosure presents batch formulations, manufacturing parameters (screening at 710 µm/210 µm, diffusion mixing, Dosator filling), and three strengths. It does not present comparative dissolution, stability, or bioavailability data against the admitted prior‑art (lactose‑containing) formulation. Without that, any later‑pled unexpected‑results argument must be supported by evidence not in the patent (In re Kollman, 595 F.2d 954 (CCPA 1979); In re Soni, 54 F.3d 760 (Fed. Cir. 1995) requires the difference to be "substantial" and unexpected).
• Commercial success lacks nexus. THALOMID's success is overwhelmingly attributable to (i) the active ingredient, (ii) the FDA‑mandated S.T.E.P.S. restricted‑distribution program, and (iii) orphan‑drug and NDA exclusivities — not to the choice of pregelatinized corn starch or a 40 % load. No nexus → no weight (In re GPAC Inc., 57 F.3d 1573 (Fed. Cir. 1995)).
• Copying by ANDA filers is not probative. Lannett's and Natco's proposed 50/100/150/200 mg capsules are AB‑rated generics; copying a formulation to obtain therapeutic equivalence is expected, not evidence of non‑obviousness.
• Alleged long‑felt need is undercut by the record. The "lactose‑free" rationale is presented generically for primary/secondary amine actives. Thalidomide is a glutarimide/imide, not a primary or secondary amine, which weakens the asserted necessity; and lactose‑free capsule matrices were standard by the priority date.

7. Weaknesses in this § 103 case (fairness points a patentee would press)

1. Exact‑number claims invite a "criticality" argument. Celgene can argue the precise 74 mg and 297.5 mg starch figures and the 125/500 mg fills are not arbitrary but are required for a specific fill density/appearance/dissolution profile. The counter is that the numbers follow arithmetically from a 40 % load and standard capsule capacities — which the patent's own Example 1 (40 wt %, 500 mg, size #0) demonstrates. Absent comparative data, the "criticality" argument lacks record support.
2. Reference sufficiency. I could verify only bibliographic entries for several NPL items (e.g., the Clark Drug Safety article, the full Remington pages, and the Guo article). A POSA declaration must quote the actual disclosures — particularly the capsule‑size table and the pregelatinized‑starch/lubricant passages — rather than rely on the titles. This is the single biggest evidentiary gap in the analysis above.
3. Teaching away. I found no reference that teaches away from pregelatinized corn starch, from a 40 % drug load, or from size‑4/size‑2/size‑0 capsules. If Celgene can identify one, the calculus changes.
4. Priority‑date scope. Because priority is claimed to 14 Nov 2002 (provisional 60/426,016), only references public before that date (or the 14 Nov 2001 § 102(b) bar date) are squarely § 102/§ 103 art. The Thalomid PDR 53rd–56th eds. (1999–2002), Remington, Teo 1999/2000, Scheffler 1999, Baker 2000, and Alebiowu 2001 all fall before the critical date; the 57th–61st PDR eds. (2003–2005) do not. The claim chart above uses only pre‑critical‑date references, so the combination is sound — but a defendant must be careful not to build on the post‑dating PDR editions or Guo (Sep. 2002, which is pre‑provisional but only by ~2 months; its status as a printed publication on that date should be documented).
5. Related validity exposure worth flagging. (a) § 102(b)/on‑sale and public‑use exposure if the claimed 40 % load/size‑4 capsule reached the market before 14 Nov 2001 — the admission in Example 3 (a different, lactose‑containing formulation) does not resolve this, and the 100 mg/200 mg NDA approvals on 17 Jan 2003 post‑date priority. (b) Obviousness‑type double patenting against the continuation US 9,006,267 (which carries a terminal‑disclaimer asterisk and materially overlapping subject matter) is a separate, potentially cleaner challenge.

8. Bottom line

On the record before me, claims 1–10 of US 7,230,012 are vulnerable to a § 103 challenge built from (i) the Thalomid PDR label as the primary reference, (ii) Remington/Gennaro as the capsule‑formulation teaching reference, (iii) Alebiowu et al. for pregelatinized corn starch, (iv) Guo et al. for capsule fill‑weight methodology, and (v) Teo/Scheffler/Baker/D'Amato for the motivation to standardise the fill and to add 100 mg and 200 mg strengths. The claims reduce to a 40 % w/w thalidomide load in a conventional lactose‑free diluent, a standard lubricant, and the ordinary capsule size for the resulting fill weight — classic routine optimisation of result‑effective variables with a predictable outcome and a reasonable expectation of success. The strongest contrary evidence would be comparative stability/dissolution data with a demonstrated nexus, and the specification as issued contains none.

Caveat: I could not confirm whether '012 has ever been the subject of an IPR, PGR, or reexamination, nor could I retrieve the full text of every cited NPL item; the analysis above should be validated against the complete prosecution file and the actual reference disclosures before being relied upon.