US 10555939

I'll run targeted searches for this patent number and any related CAFC docket activity.

Let me look for the actual claim text and any CAFC activity specifically naming this patent.

Let me confirm the full claim set and check the Federal Circuit appeal docket that names this patent.

US 10,555,939 B2 — Analyst Summary

Verbatim identifiers preserved. Note as a threshold matter: the patent document itself consistently spells the active ingredient "pomolidomide" (a spelling that does not match the INN "pomalidomide"). Per your strict no-auto-correction rule, I reproduce it as written in the document, and flag the discrepancy rather than silently fixing it. Patent No. 10,555,939 is not to be confused with US 8,673,939 or US 6,045,501, and I have excluded results for those.

Bibliographic data

Sources: Google Patents (https://patents.google.com/patent/[US10555939B2](/patent/US10555939B2)/en), Justia (https://patents.justia.com/patent/10555939), uspto.report (https://uspto.report/patent/grant/10,555,939), Orange Book data via fda.report.

Abstract (verbatim)

"Pharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease."

Plain-language overview of the claims

Per the claim listing retrieved from a secondary aggregator (drugpatentwatch.com, updated 2026-06-16), the patent has one independent claim (claim 1) with seven dependents (claims 2–8). Uncertainty flag: I could not retrieve a full official claim set directly from USPTO PatentCenter in this session, so I cannot independently confirm that the claim set ends at claim 8; the source listing appears complete but I have not verified it against the face of the granted patent.

Claim 1 (independent) — the core monopoly:
An oral dosage form in the form of a capsule comprising:

1. "pomolidomide" at 0.1–3 wt% of the total composition;
2. a binder or filler at 70–99 wt%, where the binder/filler is a mixture of mannitol and starch, and the mannitol:starch ratio is about 1:1 to about 1:1.5.

In plain terms: a pomalidomide capsule in which the drug is a small weight fraction and the bulk is a specific mannitol + starch blend (roughly equal parts, starch slightly in excess). The claim is a formulation/composition claim, not a method-of-treatment claim.

Dependent claims (narrowing only):

• Claim 2 — drug at 0.5–2 wt%.
• Claim 3 — binder/filler at 85–99 wt%.
• Claim 4 — starch is pregelatinized starch.
• Claim 5 — mannitol is spray-dried mannitol.
• Claim 6 — adds a lubricant at 0.01–1 wt%.
• Claim 7 — lubricant at 0.1–0.5 wt%.
• Claim 8 — lubricant is sodium stearyl fumarate.

The specification discloses corresponding worked examples (Tables 1–6) keyed to 0.5 mg/#4 capsule, 1 mg/#4, 2 mg/#2, 3 mg, 4 mg and 5 mg strengths, with 62.5/125/180/240/250/300 mg total fill weights and lubricant loads of 0.16–0.75 mg. Those specific strengths are not recited in the claim listing above — the granted claim scope is defined by weight percentages and the mannitol:starch ratio.

Commercial relevance: the '939 is Orange Book–listed against POMALYST (pomalidomide, NDA 204026) for all four approved strengths (1, 2, 3, 4 mg capsules), listed as a drug-product patent with a submission date of 2020-02-21. It shares the 2030-05-19 expiry of US 9,993,467; per plaintiff antitrust complaints, the '939 issued after a terminal disclaimer aligning its expiry with the earlier formulation patents.

Litigation posture — and the CAFC question

Federal Circuit: The only Court of Appeals for the Federal Circuit docket I can tie to this patent family is Appeal No. 2021-2335. It arose from a notice of appeal filed September 17, 2021 by Celgene in D.N.J. Case 2:17-cv-03387 (Celgene v. Hetero Labs) — a case in which 10,555,939 is listed among the patents — and the appeal was voluntarily dismissed under FRAP 42(b) with mandate issued November 22, 2021. (CourtListener docket 6323341, entries 951–953; Google Patents family-litigation link to CAFC case 21-2335.)

Explicit uncertainty: I found no 2026 Federal Circuit docket naming 10,555,939. I cannot confirm any pending or decided 2026 CAFC appeal involving this specific patent. If a 2026 CAFC matter exists, it did not surface in my searches and I am not asserting one.

2026-era activity I did find (all district court / non-CAFC):

• S.D.N.Y. antitrust / Walker Process actions naming the '939: Louisiana Health Service & Indemnity Co. v. Celgene, 1:23-cv-07871 (filed 2023-09-05); New York Hotel Trades Council v. Celgene, 1:24-cv-02230; CenterWell Pharmacy, Inc. v. Celgene, 1:24-cv-06924; The Cigna Group v. Celgene, 1:25-cv-05237-ER (filed 2025-06-24). A 2025/2026 opinion in 1:23-cv-07871 dismissed the Walker Process theory as to the '467 and '5939 patents, holding the Tutino-Declaration allegations insufficient and rejecting the sham-litigation theory.
• D.N.J. ANDA/infringement matters, including Celgene v. Sandoz (2:25-cv-16878), resolved by a consent judgment and permanent injunction entered November 17, 2025, naming the '939 among the patents-in-suit alongside 8,828,427 and 9,993,467.
• PTAB: no IPR naming the '939 appeared in my searches; the listed pomalidomide IPRs (e.g., IPR2015-01092) concern other Celgene patents.

Bottom line

US 10,555,939 is a Celgene/BMS formulation patent on pomalidomide capsules, issued 2020-02-11 on a 2018 continuation, claiming priority to May 19, 2009, listing Tutino and Kelly as inventors, and expiring (with pediatric extension) in November 2030. Its sole independent claim covers a pomalidomide capsule with 0.1–3 wt% drug and 70–99 wt% of a mannitol/starch blend at roughly 1:1–1:1.5. It has been asserted in ANDA litigation and cited in antitrust suits; its single identified Federal Circuit appearance (No. 2021-2335) was dismissed in 2021, and I found no 2026 CAFC docket for it.

I'll research litigation involving US Patent 10555939 systematically. Let me start with searches on the litigation portals and court records.

Let me dig deeper into specific case numbers and the litigants.

Litigation Involving U.S. Patent No. 10,555,939

Important caveat up front: I could not independently verify every docket listed below against live PACER/Unified Patents dockets within this session. Where I am relying on the patent's own "family has litigation" metadata (Google Patents) or secondary aggregators (drugpatentwatch, PatSnap, CourtListener, the Stanford NPE database), I say so. I have not auto-corrected any numbers; all case numbers and patent numbers are reproduced literally as found. Parentheticals note where a source disagrees with the patent text.

1. What the '939 patent is

U.S. 10,555,939 ("Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione"), assigned to Celgene Corporation (now a BMS subsidiary), issued Feb. 11, 2020, and is a formulation patent covering Celgene's POMALYST® (pomalidomide) product (NDA 204026). It is a continuation of the '427 and '467 formulation patents. Anticipated expiration May 19, 2030 (with pediatric exclusivity to Nov. 19, 2030). Because it issued in 2020 — after most generics filed their ANDAs — it was asserted in a separate, later wave of suits, mostly filed around March 2020 and again in 2025.

2. Hatch-Waxman (ANDA) patent-infringement cases asserting the '939 patent

Context on the 2020 wave: Per an antitrust complaint (CenterWell/Cigna line of cases), Celgene filed "substantially identical complaints alleging infringement of the '5939" against multiple generic manufacturers on March 10, 2020 — this corresponds to the 2:20-cv-02593/02597/02601/02606/02607/02608/02614 cluster in D.N.J. The aggregator drugpatentwatch lists the '939 patent against the (earlier) Hetero and Dr. Reddy's dockets, presumably by amendment.

3. Federal Circuit appeal

4. Antitrust "sham litigation / reverse payment" cases naming the '939 patent (S.D.N.Y.)

These are not patent-infringement suits on the '939 patent, but they name the '939 patent as part of the alleged monopolization scheme and were returned in drugpatentwatch's 10,555,939 results:

In these complaints the '939 formulation patent is referenced as "the '5939" (to distinguish it from the method-of-use patent 8,673,939, referred to as "the '3939"), and is alleged to expire May 19, 2030.

5. Summary and honesty caveats

• Yes, extensive litigation exists involving U.S. 10,555,939 — it is a well-asserted Orange Book formulation patent for POMALYST®.
• Confirmed outcomes: The Cipla (2:25-cv-01147) and Sandoz (2:25-cv-16878) suits both ended in stipulated consent judgments and permanent injunctions (2025), barring generic entry until patent expiration.
• Confirmed generics sued (by name in sources): Cipla, Sandoz, Dr. Reddy's, and Hetero. The March 2020 wave (2:20-cv-025xx/026xx) targeted numerous other generics (industry reporting names Natco/Breckenridge, Aurobindo, Teva, Eugia, Mylan among Pomalyst ANDA filers), but I did not confirm the specific defendant matched to each 2:20-cv-026xx docket within this session — treat those pairings as unverified.
• What I could NOT confirm: the parties in Google Patents' listed dockets 2:22-cv-01993, 2:25-cv-06320, and 2:25-cv-13687; the parties/issues/outcome of CAFC 21-2335; and the exact defendant for each 2:20-cv-025xx/026xx docket. I did not fabricate these.
• No PTAB (IPR/PGR) proceedings specifically on the '939 patent appeared in the sources retrieved (the PTAB hits were on earlier patents like 5,635,517 and 6,045,501). I flag this as "none found," not as a definitive negative.

Methodological note: The authoritative source I was given is the Google Patents page, and its litigation metadata lists the D.N.J. case numbers above. Where a secondary source (drugpatentwatch) added a 2017 Hetero docket and the "28:1338" characterizations, I have reproduced those literally rather than reconciling them. If you need docket-level certainty on the unidentified 2:20-, 2:22-, and 2:25- cases, the next step would be pulling each RECAP docket directly from PACER.

I'll start by verifying the structured ODP block against what web sources show for this patent's PTAB history.

Let me drill into patent-specific PTAB dockets and the litigation page for the '939.

Now let me specifically check for any IPR on the '939 and its sibling formulation patents.

Proceedings overview

Zero AIA trial proceedings are on file against US 10,555,939. The canonical ODP block in this prompt reports no AIA trial proceedings, and my independent web checks corroborate that — the pomalidomide/POMALYST PTAB datasets I could reach list IPRs only against other Celgene patents (notably US 5,635,517, US 6,045,501, and US 6,315,720), all filed in 2015 by the Coalition for Affordable Drugs VI LLC. Status breakdown therefore reads: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0.

Bottom line for a defendant: this is not a "hardened by surviving IPRs" story, and it is not a "claims already canceled" story either. It is an untested-at-the-PTAB formulation patent. Nothing about it has been adjudicated by the Board. The patent is alive, unamended, and carries no § 315(e)(2) estoppel against anyone. That cuts both ways: you have a clean slate to file, but you also get zero free wins from a prior petitioner's work product.

(Caveat on sourcing: I could not open PTAB E2E / PTAB Decisions directly in this session. My statement that no IPR exists rests on the ODP block plus third-party PTAB dockets that show no case for 10,555,939. If a very recent, not-yet-indexed petition exists, I could not have seen it.)

Related proceedings that do NOT involve US 10,555,939 — do not conflate these

These come up in every pomalidomide search and are frequently mis-cited against the '939. They are different patents and generate no estoppel as to the '939.

Coalition for Affordable Drugs VI LLC v. Celgene Corporation (US 6,045,501 and US 6,315,720) — not this patent

• Type: Inter Partes Review
• Filed: 2015-04-23 ('501); the '720 petition followed in the same window
• Status: Institution granted 2015-10-27. Oral hearing 2016-07-21. Final Written Decisions 2016-10-26 held the '501 and '720 patents invalid, primarily obviousness over certain publications (per Celgene's own Form 10-Q disclosures).
• Rehearing: Celgene requested rehearing 2016-11-25. On 2017-09-08 the Board denied rehearing as to the '501 and granted it as to a certain claim of the '720.
• Defensive value for the '939: essentially none. These are REMS/REMS-adjacent patents in a different family. Useful only as a narrative signal that Celgene's pomalidomide/REMS patents have been vulnerable at the Board — not as a legal ground.

Coalition for Affordable Drugs VI LLC v. Celgene Corporation (US 5,635,517) — not this patent

• Type: Inter Partes Review
• Filed: 2015-05-07
• Status: Decision date listed as 2015-11-16 in the DrugPatentWatch PTAB table.
• Defensive value for the '939: none. The '517 is the compound patent (Revlimid-era Muller patent); it is not in the '939's formulation chain.

Strategic summary

Claim status on the '939. Because no AIA trial has ever been instituted, no claim of 10,555,939 is canceled, and no claim has been adjudicated sustained by the Board. Every claim is untested at the PTAB. (I do not have the issued claim set in front of me in this session, so I will not guess at claim numbers or independent/dependent structure — treat "untested" as applying to the full claim set.) What has happened to this patent is litigation-driven: Celgene sued a large generic cohort on the '939 within roughly a month of issuance (complaints filed 2020-03-10 against Apotex, Natco/Breckenridge, Hetero, Aurobindo, Mylan, and others per the antitrust complaints), and those district-court cases were resolved by settlement, not by PTAB or trial verdict. The settlements reportedly set a generic entry date in Q1 2026 (per the reverse-payment allegations in the S.D.N.Y. antitrust complaints). Note also that the '939 expires 2030-05-19 per the patent front page — and the Orange Book lists a 2030-11-19 date reflecting six months of pediatric exclusivity.

Estoppel landscape. There is no § 315(e)(2) estoppel attaching to US 10,555,939 — estoppel only arises from a petitioner's own instituted IPR or PGR, and no such proceeding exists. Practically: if you are a target today, the entire prior-art universe is available to you, including art that was already before the examiner and art a hypothetical prior petitioner would have raised. Two honest counterweights: (1) if you are a privy of a party that already settled the '939 district-court litigation without an IPR, there is no statutory estoppel, but watch contractual/consent-judgment issues; and (2) if a future petitioner files, that petitioner — not you — will be estopped, so a well-coordinated multi-defendant IPR strategy has real value here precisely because the ground floor is empty.

Pattern signals. Celgene/BMS is a repeat IPR target (Coalition for Affordable Drugs VI, Actavis IPRs against US 8,138,229, etc.), but the pomalidomide generics chose district court and settlement over the PTAB for the formulation patents. I found no evidence of a defensive aggregator (Unified Patents, RPX, etc.) petitioning this patent. The generics' validity attack ran through ANDA litigation counterclaims + Markman + the reverse-payment antitrust suits, not through the Board. That is a real, defensible observation: this patent was asserted against ~nine generic ANDA filers and none of them filed an IPR on it. The most plausible explanations are the short runway to the agreed 2026 entry date and the desire not to jeopardize settlement posture — not that the patent is bulletproof. The antitrust complaints in fact allege the '939 is invalid as obvious over Zeldis, Remington's, and McNally and was obtained using a Tutino declaration the examiner "expressly stated it was not persuaded by," with issuance coming only after a terminal disclaimer over the '427 and '467. That is a roadmap, not a verdict.

One more litigation item you asked about. The family block shows a Federal Circuit case, 21-2335, tied to this patent's family. I could not confirm from the sources I reached whether that is an appeal from the '939 district-court litigation, from a related-patent case, or an IPR appeal — and I will not guess. Flag it and pull the docket before relying on it.

Recommended next steps

If you are a defendant today.

• There is no FWD to cite and no canceled claim to point at. Any demand letter or complaint asserting the '939 cannot be answered with a Board disposition, because none exists. Your defense is built from scratch: § 102/§ 103 over the Zeldis/Remington's/McNally art family, plus the § 112 (indefiniteness, written description, enablement) theories the generic defendants advanced in district court.
• Check your § 315(b) clock. If you or a privy have been served with a complaint asserting the '939, you have one year from service to file. With the patent not expiring until 2030-05-19 (2030-11-19 with PED), an IPR filed now still has years of post-FWD life to run — the runway calculus that discouraged the 2020-era generics is materially different for a fresh target.
• Post-grant routes are closed. PGR is unavailable (the '939 issued from an application filed 2018-05-10 claiming 2009 priority; the 9-month window is long past), and CBM is unavailable both because this is a pharmaceutical formulation patent and because the CBM transitional program itself has sunset.
• Consider the district-court record as estoppel-free ammunition. The generic co-defendants' invalidity contentions (e.g., in Celgene v. Hetero, No. 17-cv-3387 (D.N.J.)) and the Markman rulings are public and not PTAB estoppel-laden; they can be reworked into petition grounds. Cite the S.D.N.Y. antitrust complaint and the Celgene v. Hetero / Celgene v. Aurobindo / Celgene v. Dr. Reddy's dockets for the invalidity theories that were briefed but never adjudicated to judgment.
• If you want the primary documents: patent text and prosecution history at https://patents.google.com/patent/[US10555939B2](/patent/US10555939B2)/en; family litigation/PTAB dockets at https://www.drugpatentwatch.com/p/alphasignals/litigation/drugname/index.php?query=POMALYST; and the antitrust pleadings at https://storage.courtlistener.com/recap/gov.uscourts.nysd.[628251](/patent/628251)/gov.uscourts.nysd.628251.1.0.pdf.

If you are monitoring rather than defending. The absence of any IPR on a patent that was asserted against roughly nine ANDA filers is itself the signal — it strongly suggests no IPR has been filed, not merely that one is unindexed. Re-check PTAB E2E periodically; the natural filing window for a fresh target is open and unencumbered.

I'll research the assignment record for US 10,555,939 through the USPTO Assignment Center and cross-reference sources.

Let me search for the specific assignment record details and the Celgene→BMS change of name.

Let me look for the specific assignment reel/frame and check for any BMS-related title records.

Assignment & Ownership Analysis — US 10,555,939 B2

Verification status up front: I was unable to open USPTO Assignment Center (assignmentcenter.uspto.gov / assignment.uspto.gov) or PACER in this session — my searches returned the Google Patents legal-events block (already supplied to me as authoritative), SEC merger documents, and litigation filings, but no direct reel/frame record page. Accordingly, I report the existence and dates of recorded assignment activity from the authoritative Google Patents legal-events block, and I flag plainly where a field (reel/frame, correspondent) could not be verified rather than guessing. I have not fabricated any reel number or attorney name.

Inventors

Both are Celgene formulation scientists; the assignment to Celgene was executed/recorded in the same window as the 2018-05-10 filing (see timeline). Consistent with the earlier-generated section, both inventors are still at Celgene/BMS as far as any source shows — there is no evidence of the "inventors depart within 12 months of filing" pattern that often precedes a portfolio fire-sale. Residence towns (New Providence and Lake Hopatcong, NJ) are both commuter-range to Celgene's Summit, NJ headquarters, corroborating employee inventors rather than outside contractors.

Unusual-pattern note: none present. The inventors never broke the chain — they assigned directly and only to their employer.

Original assignee

Celgene Corporation (Summit, NJ; principal IP address of record in the litigation filings was 7 Powder Horn Drive, Warren, NJ 07059 — see the Celgene assignment exemplar surfaced in Celgene v. Hetero, D.N.J. 2:17-cv-03387, Doc. 250-30).

• Line of business: operating biopharmaceutical company (now a wholly owned Bristol-Myers Squibb subsidiary). Not an IP-holding entity.
• Product embodying the claims: Yes. The '939 is Orange Book–listed as a drug-product patent against POMALYST® (pomalidomide, NDA 204026), all four approved strengths (1, 2, 3, 4 mg capsules). This is a genuine commercial product, not a paper patent.
• Current status: Operating as a BMS subsidiary. Bristol-Myers Squibb completed its acquisition of Celgene on 2019-11-20; Celgene "became a wholly owned subsidiary of Bristol-Myers Squibb Company" (BMS press release, 2019-11-20). Critically, this was a stock acquisition, not a merger into the parent — Celgene Corporation survived as a separate legal entity, so no assignment or change-of-name recordation was legally required to keep title with Celgene Corporation. That is why the chain shows no 2019–2020 BMS recording.

Assignment timeline

Only one recorded assignment event touches this patent, and it is the original inventor→employer assignment. The Google Patents legal-events block supplies one reassignment entry; it does not display reel/frame or correspondent, and I could not reach Assignment Center to fill those fields.

• 2018-05-10 (filing) / recorded 2018-11-06 — Reel/Frame not verifiable in this session (Assignment Center inaccessible)
  • Conveyance: Assignment — "ASSIGNMENT OF ASSIGNORS' INTEREST (SEE DOCUMENT FOR DETAILS)"
  • Assignor: TUTINO, ANTHONY J.; KELLY, MICHAEL T.
  • Assignee: CELGENE CORPORATION
  • Correspondent: Not retrieved — Google Patents legal events do not expose the recording correspondent, and Assignment Center was unreachable. I will not name an attorney I cannot source.
  • Context: Standard employee invention assignment (inventors to their employer), not a fire-sale, securitization, or transfer-to-asserter.

Post-issuance assignments: NONE recorded or surfaced. There is no assignment of the '939 away from Celgene Corporation — no LLC, no trust, no security interest, no license recordation appearing in any source I retrieved. The absence of any post-issuance assignment is itself the key finding: title has remained with the original operating-company assignee.

(Direct USPTO verification link: https://assignment.uspto.gov/patent/index.html — search "10555939". I was unable to run that query live; a reader should do so to confirm the reel/frame of the 2018-11-06 record and confirm the absence of later records.)

Timeline diagram

timeline
    title Ownership of US 10555939
    2009 : Provisional priority filed
    2010 : Parent app 12 783 390 filed
    2015 : Continuation 14 998 262 filed
    2018 : Continuation 15 976 808 filed
         : Inventors assign rights to Celgene
    2019 : Celgene acquired by Bristol Myers Squibb
    2020 : Patent granted to Celgene

NPE / troll-pattern signals

Verdict

Operating-company assertion.

Justification. The full chain is a single inventor-to-employer assignment recorded 2018-11-06 to Celgene Corporation, with zero subsequent transfers — no shell LLC, no known asserter, no cascading or pre-litigation transfer, and no bankruptcy sale. Celgene ships the patented product (POMALYST®, NDA 204026) and asserted the '939 itself against actual generic competitors, which is the defining feature of operating-company assertion rather than NPE conduct; the Stanford NPE Database correspondingly tags the asserter as a "Product company." The one ownership change around this patent — BMS's 2019-11-20 acquisition of Celgene — was a stock purchase that left Celgene Corporation intact as a subsidiary, so it generated no recordable assignment and does not alter the analysis. Confidence is high on the absence of NPE signals; the residual gap is purely administrative (unverified reel/frame and correspondent due to Assignment Center being unreachable), which does not change the verdict.

Verification link: https://assignment.uspto.gov/patent/index.html (query "10555939") — recommend pulling the 2018-11-06 record's reel/frame and confirming no later conveyance, which I could not do live.

I'll research the prior art cited on the face of US 10,555,939 and any later citations. Let me pull the patent's citation data from multiple sources.

Let me pull the specific cited references list for the '939 patent and the key prior-art references identified during prosecution.

I have a substantial citation list. Let me retrieve the complete patent-citation table and the non-patent-literature citations for this family.

Prior Art for US 10,555,939 — Cited References and § 102 Analysis

Sourcing / method note

I searched for the citation records attached to US 10,555,939 (and its sibling family members, which share an identical citation set). Two honest limitations up front:

• I was able to retrieve the front-page patent-citation table only in part. The complete list is rendered on the family's EP sibling EP 3 199 149 A1, which the patent's own Google Patents page shows carries "Patent Citations (34)" — but my retrieval returned roughly the first third of that table before I ran out of search budget. I reproduce below what I actually saw, and I flag the remainder as not retrieved rather than reconstructing it.
• The non-patent-literature citations are not fully enumerated on the face of the US patent in what I retrieved. However, the prosecution history is unusually well documented (because it is quoted at length in the Pomalyst antitrust complaints), so I can state with confidence which references the Examiner actually relied on.

Critical framing before the tables. The '939 is a formulation/composition claim. Claim 1 (and every dependent claim 2–8) requires all of the following to be present in a single reference before that reference can anticipate under § 102:

1. an oral dosage form in the form of a capsule;
2. pomolidomide at 0.1–3 wt% of the composition;
3. a binder/filler at 70–99 wt% that is a mixture of mannitol and starch; and
4. a mannitol:starch ratio of about 1:1 to about 1:1.5.

None of the references cited on the face of the '939 discloses all four elements together. No cited reference anticipates claim 1 — and therefore none anticipates claims 2–8 either. The cited art is § 103 (obviousness) art, not § 102 (anticipation) art. That is the central and honest finding, and it matches how the Examiner actually used the art (obviousness rejections over Zeldis + Remington's + McNally).

The effective prior-art cutoff: earliest priority is the 2009-05-19 provisional (61/179,678); the parent was filed 2010-05-19. Everything below published well before 2009 and is therefore § 102(b) prior art — available for both anticipation and obviousness.

A. Patent-document citations (verified portion of the 34 listed)

All of the following are Celgene's own patents/publications (the inventor is Jerome B. Zeldis for nearly all). They are "cited" largely as background/incorporation-by-reference under 37 CFR 1.57. None is a formulation reference.

Not yet retrieved (balance of the 34-item table). From the '939 specification's own "incorporated by reference" list, the remaining cited Celgene documents almost certainly include US 2005/0239842, US 2006/0154880, US 2006/0122228, US 2005/0143420, US 2006/0030594, US 2007/0048327, US 2004/0190609, and US 6,281,230. I could not verify their presence in the front-page table itself and I am not asserting their citations as fact — but each is referenced in the patent body as background, and none discloses the claimed capsule formulation. My § 102 conclusion (no anticipation) holds regardless of whether these are added.

B. Non-patent literature relied upon (from the prosecution record)

The Examiner's rejections are quoted verbatim in the Pomalyst antitrust complaints. These are the most relevant references for any validity attack, and they are the same § 103 combination the Examiner actually made:

How the Examiner applied them: the stated rejection was obviousness of an oral dosage form comprising pomalidomide with mannitol and pregelatinized starch, in view of Remington's (capsule sizes, spray-dried mannitol) and McNally (sodium stearyl fumarate). The rejection was overcome only by a declaration (the Tutino Declaration, June 2013/June 2014) asserting unexpected stability results. That declaration is the crux of the inequitable-conduct/Walker-Process allegations — i.e., the art was defeated by evidence, not by absence of art.

C. What is not prior art (do not miscite)

• US 8,828,427 and US 9,993,467 — these are the parent/sibling members of the same family (the '939 is a continuation). They are not prior art to the '939 (same family, common priority) and are relevant only as obviousness-type double-patenting references; the '939's own record reflects a terminal disclaimer aligning expiry with them.
• Forward citations — e.g. CN 104042590 (pomalidomide + anhydrous lactose/dextrin/croscarmellose/PEG 4000), CN 104224723 (pomalidomide nanoparticles), CN 104523692 (pomalidomide/cyclodextrin complexes), US 11,517,536 (pomalidomide + maltodextrin) — these are later documents that cite the '939 family. They are prior art to those later filings, not to the '939, and cannot be § 102 art against it.

D. Bottom line on § 102

• Most relevant prior art for US 10,555,939: the Celgene/Zeldis pomalidomide oral-dosage-form publications, combined with Remington's (capsule sizes, spray-dried mannitol) and McNally (sodium stearyl fumarate). This is the combination the Examiner found prima facie obvious.
• Anticipation: no cited reference anticipates any of claims 1–8. To anticipate, a reference would have to disclose a pomalidomide capsule at 0.1–3 wt% drug with a 70–99 wt% mannitol+starch binder at a ~1:1–1:1.5 ratio; none does. The cited art is § 103 art.
• Claim-by-claim § 102 note: since every one of claims 1–8 incorporates claim 1's capsule-and-ratio limitations, the "no anticipation" conclusion applies to all of claims 1–8. The dependent claims add only narrowing features (drug wt% 0.5–2%; filler 85–99 wt%; pregelatinized starch; spray-dried mannitol; lubricant 0.01–1 wt%, 0.1–0.5 wt%, or sodium stearyl fumarate) — none of which is disclosed in combination in the cited references.

E. Explicit uncertainties

1. I retrieved only ~12 of the 34 front-page patent citations; the remainder are inferred from the specification's incorporation-by-reference list, not confirmed against the face of the patent. This does not change the § 102 result.
2. I could not open USPTO PatentCenter / USPTO's own citation export in this session; the citation data above comes from the family's EP sibling (EP 3 199 149 A1) and the patent's Google Patents page. If you need a certified § 102(c)/(e) statement, pull the official "References Cited" from the '939's PDF front page and the "PTOL-892" from the file wrapper.
3. Characterizing a reference as "anticipating" is ultimately a legal conclusion; the above is a disclosure-sufficiency assessment only.
4. Date discrepancy noted: the task header says "current date April 26, 2026," while the session timestamp shows 2026-10-01; I treated the analysis as current without altering any identifier or date in the references themselves.

I'll gather the prior-art references actually cited against this patent and the record of the key prosecution fight before building the § 103 analysis.

Let me pull the issued claim set of the '939 and the specific prior-art references named in the record (Zeldis, Remington's, McNally) plus the prosecution rejections.

I have what I need: the issued claim 1, the specific references the examiner and the litigation used (Zeldis publications, Remington's, McNally, Schey, Kibbe), and the prosecution narrative. Before building the § 103 case, one framing note and one flagged contradiction.

Flagged contradiction (per my standing instruction to surface conflicts). My earlier patent-summary section listed claim 3 as "binder/filler at 85–99 wt%". A Cigna-complaint excerpt retrieved this session shows a dependent claim 3 reciting "the binder or filler is present at an amount of 95 to 99 weight percent." I cannot reconcile these from the sources available; I flag it and do not silently adopt either. It does not affect claim 1, which every source agrees reads 70–99 wt% for the binder/filler. (Sources: https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf ; my prior summary's drugpatentwatch basis.)

§ 103 Obviousness Analysis — US 10,555,939

1. Governing standard and the critical date

Under 35 U.S.C. § 103, the question is whether the subject matter of claim 1 as a whole would have been obvious to a person having ordinary skill in the art (PHOSITA) at the time the invention was made. The analysis proceeds through the Graham v. John Deere factors (scope and content of the prior art; differences between the prior art and the claims; level of ordinary skill; secondary considerations), applied with the flexibility KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) requires.

Critical date. The '939 issues from application 15/976,808 (filed 2018-05-10) but is a continuation carrying the benefit chain back to U.S. Provisional 61/179,678, filed 2009-05-19. Because no claim has an effective filing date on or after 2013-03-16, the pre-AIA §§ 102/103 regime applies, with a critical date of 2009-05-19 and a § 102(b) one-year bar date of 2008-05-19. That matters: the references discussed below all predate the 2008-05-19 bar and qualify as § 102(b) printed publications, which is the cleanest, most defensible art status. (Source for priority chain: https://patents.google.com/patent/[US10555939B2](/patent/US10555939B2)/en.)

An important art-status nuance the record occasionally blurs. The Zeldis patents themselves (US 8,198,262; 8,735,428; 8,673,939) issued 2012–2014, i.e., after the 2009 critical date, so they are not § 102(b) art against the '939. What is § 102(b) art is the Zeldis family's earlier published applications (referred to in the pleadings as the '832 and '708 publications, which "have the same disclosure as the Zeldis Patents"). That is exactly why the defendants' expert (Dr. Park) charted the publications, not the patents — and why Celgene objected to using the patents for § 103 (the patents had previously been used only for obviousness-type double patenting). (Sources: https://www.carlsoncaspers.com/wp-content/uploads/2021/07/Celgene-Corp.-v.-Hetero-Labs-Ltd..pdf ; https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf.)

2. Claim 1 (verbatim, as reproduced in the litigation)

"1. An oral dosage form in the form of a capsule which comprises: 1) pomolidomide at an amount of 0.1 to 3 weight percent of the total weight of the composition; 2) a binder or filler at an amount of 70 to 99 weight percent of total weight of the composition, wherein the binder or filler is a mixture of mannitol and starch; and wherein the ratio of mannitol:starch in the dosage form is from about 1:1 to about 1:1.5."

(Quoted as reproduced in the § 2:20-cv-02597 complaint analysis and the Cigna complaint; the '467 patent's parallel claim 1 differs only in reciting 90–99 wt% for the binder/filler. Sources: https://ai-lab-cl-prod.azurewebsites.net/case/dct/njd/2:20-cv-02597/doc/analysis/1 ; https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf.)

Note the claim is composition-only — no lubricant, no specific starch type, no specific mannitol type, no capsule weight, and no method step. It is materially broader than the '427's weight-specific claims (62.5/125/180/240/250/300 mg) and broader than the '467 in the binder/filler lower bound (70 vs. 90 wt%).

3. Scope and content of the prior art

(Sources: examiner's citations and pleading recitations at https://www.hbsslaw.com/sites/default/files/case-downloads/pomalyst-pomalidomide/2023-09-07-complaint.pdf ; https://uspto.report/patent/grant/[10,555,939](/patent/10555939) ; https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf ; https://storage.courtlistener.com/recap/gov.uscourts.nysd.[628251](/patent/628251)/gov.uscourts.nysd.628251.1.0.pdf.)

4. Level of ordinary skill

A PHOSITA here is a formulator with a B.S./M.S./Ph.D. in pharmacy, pharmaceutical sciences, or chemical engineering and roughly 2–5 years' experience developing oral solid dosage forms — i.e., someone wholly familiar with Remington's, the Handbook of Pharmaceutical Excipients, capsule sizing/fill, direct-blend vs. roller-compaction processing, and the Maillard/reducing-sugar incompatibility of amine drugs. The patent's own field (§ 1) and the litigation's invalidity contentions assume this level. (Sources: https://patents.google.com/patent/US10555939B2/en ; https://www.carlsoncaspers.com/wp-content/uploads/2021/07/Celgene-Corp.-v.-Hetero-Labs-Ltd..pdf.)

5. Differences between the prior art and claim 1

The upshot: every element except the specific ratio is expressly taught, and the ratio is a proportional-adjustment variable with no demonstrated criticality. That is the classic posture for an "obvious to try / routine optimization" holding under KSR and In re Aller.

6. The primary § 103 combination

Combination A — Zeldis + Remington's + McNally (the PTO's own combination)

The examiner did assemble essentially this combination and rejected the claims as obvious four times. The Notice of Allowance for the parent '427 confirms the rejection rested on "Zeldis" for the excipient selection, with Remington's supplying capsule sizes/spray-dried-mannitol benefits and McNally supplying sodium stearyl fumarate as a known lubricant. The claims issued only after the Tutino Declarations and a terminal disclaimer. (Sources: https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf ; https://storage.courtlistener.com/recap/gov.uscourts.nysd.628251/gov.uscourts.nysd.628251.1.0.pdf ; https://www.hbsslaw.com/sites/default/files/case-downloads/pomalyst-pomalidomide/2025-05-16-redacted-pls'-brief-iso-mot-to-file-second-am-complaint.pdf.)

Why the PHOSITA would combine them (articulated KSR rationales):

1. Same field, same problem, same art. All references are in oral solid-dosage formulation; Zeldis is Celgene's own disclosure of pomalidomide oral dosage forms, and Remington's/Kibbe are the standard formulation references a PHOSITA consults by default. KSR — familiar elements, known methods.

2. The specification's own admission supplies the motivation to pick mannitol over lactose. The '939 specification teaches that the compositions are preferably lactose-free, because lactose's presence "substantially increase[s] the degradation rate of an active ingredient that is a primary or secondary amine," and pomolidomide is an aromatic amine (4-amino). A PHOSITA seeking a non-reducing, amine-compatible diluent would be led directly to mannitol and away from lactose — the very selection the claim recites. This is intrinsic-record evidence of predictability, not unexpectedness. (Source: https://patents.google.com/patent/US10555939B2/en , § 4.)

3. Simple substitution of known excipients with predictable results. Mannitol (a non-hygroscopic, water-soluble, directly-compressible diluent that is spray-dryable and gives good flow) and pregelatinized starch (a well-known binder/filler) were two of the most common capsule diluent/binder pairs. KSR — substitution of one known element for another, predictable result.

4. A finite number of identified, predictable solutions. The formulation space (a handful of standard diluents × standard binders × standard lubricants × routine ratios) is small, and the art is predictable, so "obvious to try" applies with a reasonable expectation of success.

5. Design incentives / market forces. Pomalidomide was in clinical development (Schey, Lacy, Jagannath) with defined strengths; a commercial capsule satisfying content uniformity, manufacturability, and stability was a routine development objective.

6. Remington's/Kibbe make the filler level and ratio a routine optimization. Once the drug is fixed at 0.1–3 wt% and the diluent system is mannitol + starch, the balance of the fill (70–99 wt%) and the split between the two diluents are the ordinary dials a formulator turns. Setting mannitol:starch at ~1:1.0–1:1.5 — i.e., roughly equal parts — requires no more than routine experimentation. KSR; In re Aller (a change in a process parameter obvious where the result is expected).

Combination B — Zeldis + Remington's + Kibbe + Schey

Same core, with Kibbe's excipient monographs supplying the property/compatibility data (mannitol vs. starch vs. lactose) and Schey supplying the dose/strength rationale that fixes the 0.1–3 wt% drug load. This variant is more robust to the argument that Remington's alone is a "general" reference.

Combination C — Compound art (Muller/Corral) + Zeldis + Remington's

Establishes pomalidomide as a known compound with known oral utility (Muller (1999), Corral (1999)), removing any "new compound" predicate for nonobviousness; then the same formulation reasoning applies.

7. Dependent claims (2–8)

These rise or fall with claim 1 and add only well-known refinements:

• Drug 0.5–2 wt% — the commercial 1/2/3/4 mg strengths in Remington-sized fills; and Schey's 1–10 mg/day range.
• Binder/filler 85–99 wt% (or 95–99 wt% — see flagged discrepancy) — squarely within the working examples (which run ~98–99 wt%) and within Remington's/Kibbe typical ranges.
• Pregelatinized starch — expressly disclosed in Zeldis.
• Spray-dried mannitol — expressly taught in Remington's ("advantages of spray drying common diluents like mannitol").
• Lubricant 0.01–1 wt% and 0.1–0.5 wt% — standard lubricant levels in Remington's/Kibbe.
• Sodium stearyl fumarate — expressly taught by McNally as a known lubricant.

Because the dependents merely add excipient identities and amounts that the references expressly name, the obviousness case is actually stronger claim-for-claim at the dependent level than at claim 1. (Sources: https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf ; https://uspto.report/patent/grant/10,555,939.)

8. Secondary considerations — and the real battleground

The only thing standing between the claim set and a clean § 103 rejection is the "unexpected results" evidence of the Tutino Declarations, which the examiner credited for the '427 ("the prior art of record is silent with respect to stability of pomolidomide when combined with various excipients"; the claim "was not obvious… because applicant showed… stability… is not predictable"). Two facts materially weaken that evidence for the '939:

1. The examiner who handled the '939 itself was not persuaded by the same declaration. Per the pleadings, "the examiner expressly stated it was not persuaded by the Tutino Declaration's assertion of 'unexpected results,'" and the '939 issued only after a terminal disclaimer over the '427 and '467. If the allowance posture for the '939 was not unexpected-results-driven, the prima facie § 103 case was never actually rebutted on the merits. (Source: https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf , ¶¶ 364–365.)

2. The "unpredictability" premise is contestable. The record allegations are that (a) thalidomide analogs were known to be hydrolysis-unstable, so addressing stability was routine optimization (see Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007) — "routine optimization to reach adequate physicochemical characteristics, including stability, is not evidence of unexpected results," a case the plaintiffs cite); and (b) the tested formulations used only two ratios (≈1:1.304 and ≈1:1.331) yet the claim recites 1:1.0–1:1.5, so the data do not support the full claimed range. (Source: https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf , ¶ 289.)

Net: If the unexpected-results evidence is credited, it can rebut prima facie obviousness (In re Soni; Rambus v. Hynix). If it is discounted or the "no reasonable expectation of success" predicate falls, the combination in § 6 supports a § 103 conclusion on the '939 essentially as it did at the rejection stage. The other classic secondary factors are weak: no verified long-felt need; commercial success of POMALYST lacks nexus to the specific ratio (the drug's efficacy and the earlier '427 family drive the sales, which is why generics say the patent was "easy to design around"); and generic copying did not occur — generics designed around.

9. Bottom-line assessment

Caveats (stated honestly):

• I have not seen the actual Remington's, McNally, Kibbe, or Zeldis-publication text firsthand in this session. I have attributed their content as the examiner and the pleadings characterize it; treat that characterization as an allegation/record citation, not as my independent verification of the references' text.
• I could not confirm the exact issued claim set (claim numbering/wording for claims 2–8) from an official source this session; the claim 3 discrepancy flagged at the top is unresolved.
• This is a technical § 103 analysis, not a legal opinion; obviousness is a legal conclusion that turns on the full evidentiary record, including any rebuttal evidence the patentee would adduce.

Key URLs: https://patents.google.com/patent/US10555939B2/en • https://uspto.report/patent/grant/10,555,939 • https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf • https://www.hbsslaw.com/sites/default/files/case-downloads/pomalyst-pomalidomide/2023-09-07-complaint.pdf • https://storage.courtlistener.com/recap/gov.uscourts.nysd.628251/gov.uscourts.nysd.628251.1.0.pdf • https://www.carlsoncaspers.com/wp-content/uploads/2021/07/Celgene-Corp.-v.-Hetero-Labs-Ltd..pdf • https://ai-lab-cl-prod.azurewebsites.net/case/dct/njd/2:20-cv-02597/doc/analysis/1