US 9993467

I'll verify the patent details against live sources and check for any CAFC 2026 activity.

Let me check the granted claims and any 2026 appellate activity.

Let me confirm the granted claim text and check the Federal Circuit docket.

Verification note

I ran targeted searches against Google Patents / USPTO-derived records, Orange Book listings, litigation dockets (CourtListener, Stanford NPE database, Unified Patents), and BMS SEC filings. Findings below are grounded in those sources plus the authoritative full text you supplied. Where sources conflicted, I followed the search results. Two cautions up front:

• Literal identifier handling: the compound's correct name is pomalidomide (CC-4047). The Google Patents full text you supplied renders it repeatedly as "pomolidomide" — this appears to be a text-extraction artifact in that document, not a different compound. The granted claim text as published reads "pomalidomide" (one OCR instance in the issued PDF shows "palomidomide"). I am not auto-correcting the patent number; 9,993,467 is treated literally throughout.
• CAFC 2026 docket: I could not locate any 2026 Federal Circuit docket activity for 9,993,467. The only appellate entry surfaced in the litigation metadata is Fed. Cir. 21-1154 (year 2021, not 2026). I cannot confirm a 2026 CAFC matter exists — treat the absence of findings as "not found," not as proof of nonexistence.

Bibliographic summary — US 9,993,467 B2

Priority chain (per the specification): continuation of US 14/447,450 (filed 2014-07-30) → which is a continuation of US 12/783,390 (filed 2010-05-19, issued as US 8,828,427) → which claims priority to US provisional 61/179,678 (2009-05-19). The '467 patent issued subject to a terminal disclaimer over the '427 patent (per the litigation record), which is why the two share the same nominal expiry.

Orange Book linkage: Listed against POMALYST® (pomalidomide) capsules, NDA 204026, protected as a drug-product (DP) patent; six-month pediatric extension applied. This is the basis for its commercial relevance — Pomalyst had ~US$3.2B in U.S. sales for the twelve months ending September 2025 (Optum Rx, 2026).

Abstract (as issued)

"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."

Claims — plain-language overview

The granted patent has exactly one independent claim (claim 1); claims 2–8 depend from it (per the issued claim set reproduced in drugpatentwatch and the issued PDF).

Claim 1 (independent) — the capsule formulation. An oral dosage form in the form of a capsule containing:

1. pomalidomide at 0.1–3 wt% of the total composition;
2. a binder/filler at 90–99 wt%, where that binder/filler is a mixture of starch and mannitol; and
3. the mannitol:starch ratio is about 1:1 to about 1:1.5.

In plain terms: a pomalidomide capsule where the drug is a small weight fraction and the bulking agents are a specific two-component starch/mannitol blend held to a narrow ratio window. The ratio limitation was added by amendment on 2017-10-20 during prosecution, and it is the element that distinguishes claim 1 from the parent '427 claim set (which claimed specific absolute weights — 62.5, 125, 250, 180, 240, and 300 mg capsules).

Dependent claims (2–8) — narrowing only:

• Claim 2: pomalidomide at 0.5–2 wt%.
• Claim 3: binder/filler at 95–99 wt%.
• Claim 4: the starch is pregelatinized starch.
• Claim 5: the 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: the lubricant is sodium stearyl fumarate.

Note the claim-then-publish nuance: the published application (US 2016/0206607) had a much broader independent claim 61 reading "binder or filler is starch, mannitol or a mixture thereof" with a 90–99 wt% range and no ratio limitation. Claim 1 as granted is materially narrower — the mixture is mandatory and the mannitol:starch ratio window was added.

Litigation context (relevant to enforcement posture)

The '467 has been asserted in the Pomalyst ANDA litigation wave in D.N.J. Documented matters involving this patent number include (not exhaustive):

• Celgene Corp. v. Apotex Inc., 2:18-cv-16395 (D.N.J.)
• Celgene Corp. v. Hetero Labs Ltd. et al., 2:20-cv-02601 (D.N.J.)
• Celgene Corp. v. USV Private Ltd., 2:25-cv-06320 (D.N.J.)
• Additional 2018–2025 D.N.J. entries surfaced in Unified Patents/Google litigation metadata (e.g., 2:18-cv-14111, 2:18-cv-14366, 2:18-cv-14715, 2:18-cv-16035, 2:19-cv-00143, 2:19-cv-05802, 2:21-cv-02111, 2:22-cv-01993, 2:25-cv-01147, 2:25-cv-13687, 2:25-cv-16878)
• Fed. Cir. 21-1154 — the only appellate docket surfaced; it is a 2021 appeal, not a 2026 matter
• Celgene v. Sandoz — consent judgment entered 2025-11-17 naming US 8,828,427; 9,993,467; and US 10,555,939 as the Patents-in-Suit, permanently enjoining Sandoz's ANDA No. 220741. Claims dismissed with prejudice; no merits ruling on the '467.

Two caveats on the litigation record: the '467 did not exist when the February 2017 ANDAs were filed, so suits on it could not trigger a 30-month stay (per the S.D.N.Y. antitrust complaint). And the Sandoz consent judgment contains no validity or infringement holding, so it provides no merits precedent for other challengers. Separately, the S.D.N.Y. Pomalyst antitrust class actions (filed from September 2023) allege the '467 was procured via allegedly deceptive Tutino declarations and is invalid/obvious — those are allegations in a complaint, not adjudicated findings. In March 2025 the S.D.N.Y. court dismissed the complaints against Celgene, BMS and named individuals; plaintiffs sought leave to amend.

Explicit uncertainties

1. No 2026 CAFC docket found. My searches did not surface any Federal Circuit proceeding in 2026 involving 9,993,467, nor a 2026 merits decision. If one exists, it did not appear in the sources searched.
2. Claim-set completeness. The independent/dependent structure above (1 independent claim; claims 2–8 dependent) is drawn from the issued patent PDF text and drugpatentwatch claim listings, consistent with the litigation pleadings. I did not independently re-verify the total claim count directly against USPTO PatentCenter.
3. Sequence listings / tables. The Google Patents text supplied omits the numeric content of Tables 1–6 (batch and single-dosage formulations), the HPLC gradient table, and the "systemic arteries" chart referenced in the specification. My description of the worked examples relies on the surrounding prose and the separate issued-PDF table capture.
4. Name rendering. "Pomolidomide" appears throughout the provided full text; I have treated this as a rendering artifact for pomalidomide rather than a distinct chemical entity.

I'll research litigation involving US 9993467 using the specific case numbers and patent number. Let me search multiple sources.

Let me search for more specific cases and the NPE database entries.

Let me get more detail on the specific cases and defendants.

Litigation Involving U.S. Patent No. 9,993,467

Patent context (from the authoritative patent record): U.S. 9,993,467 B2, titled "Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione" (pomalidomide, a/k/a CC‑4047), is assigned to Celgene Corporation (now a Bristol‑Myers Squibb subsidiary). Application 14/998,262 was filed Dec. 23, 2015; the patent issued June 12, 2018, claiming priority to May 19, 2009. It is an Orange Book‑listed patent covering Celgene's Pomalyst® (NDA No. 204026). It is one of the "later‑issued" formulation patents in the same family as U.S. 8,828,427 and 10,555,939, all of which were asserted together against generic pomalidomide ANDA filers.

Important caveat on scope: Almost all of this litigation is Celgene as plaintiff suing generic ANDA filers for infringement under 35 U.S.C. § 271(e)(2) in the U.S. District Court for the District of New Jersey (D.N.J.). Many of the earlier cases were consolidated into a lead case (Celgene v. Hetero, No. 17‑cv‑3387), which is why the docket records are fragmented. Where I could not confirm a specific defendant or date, I say so explicitly rather than guessing.

A. Cases listed on the patent's own litigation record (Google Patents, sourced from Unified Patents)

B. Notable details on the key contested matter

• Celgene Corp. v. Mylan Pharmaceuticals Inc., No. 2021‑1154 (Fed. Cir. Nov. 5, 2021) — The Federal Circuit affirmed dismissal of Celgene's suit for improper venue, holding Mylan lacked a "regular and established place of business" in New Jersey and that the ANDA submission (not the paragraph IV notice letter) is the operative infringing act. Opinion by Judge Prost (Prost, Chen, Hughes). This is the only substantive appellate decision in this group.

C. Active/terminated status summary

• Terminated by settlement/injunction: Dr. Reddy's (2022), Cipla (Sept. 2025), Sandoz (Nov. 2025) — each resolved by stipulated consent judgment and permanent injunction prohibiting U.S. marketing before expiration of the '467 (and the '427/'939) patents.
• Terminated by venue dismissal: Mylan (2020, affirmed 2021).
• Remaining open (per Google Patents status "Active"): 2:22‑cv‑01993, 2:25‑cv‑06320 (USV), 2:25‑cv‑13687, plus associated matters.

D. Related (non-infringement) litigation referencing the '467 patent

Several antitrust suits challenge the enforcement of Celgene's pomalidomide patents including the '467:

• In re Pomalyst Antitrust Litigation (S.D.N.Y., cases filed beginning Sept. 2023, e.g., 1:25-cv-05237-ER (The Cigna Group v. Celgene Corp.)). Complaints (Cigna, HBS/Hagens Berman plaintiffs) characterize the '467 as one of several "sham" formulation patents. Per BMS's 2026 filings: complaints dismissed (March 2025), leave to amend denied and judgment entered for defendants (March 2026), notice of appeal to the Second Circuit filed April 2026.

Reliability notes

• Case numbers, parties, and statuses above are drawn from the authoritative patent page (Google Patents, Unified Patents data) and corroborating PACER/CourtListener dockets and the Federal Circuit opinion.
• I could not, within this search, positively confirm the specific defendant names for cases 2:18‑cv‑14111, 2:18‑cv‑14366, 2:18‑cv‑14715, 2:18‑cv‑16035, 2:19‑cv‑00143, 2:22‑cv‑01993, and 2:25‑cv‑13687 (all generic ANDA filers in the consolidated Pomalyst litigation), nor exact filing dates for the 2018/2019 filings. I am flagging these rather than fabricating them.
• The Cipla attribution for 2:25‑cv‑01147 is my inference from the filing/resolution dates matching the reported Cipla case (filed Feb. 10, 2025; closed Sept. 17, 2025), not a directly confirmed case‑number match.

I'll start by confirming the canonical list and then search for any PTAB proceedings that may not be indexed in the ODP.

Let me run a few more targeted searches to confirm whether any IPR has ever targeted the '467 patent itself.

Let me check whether any AIA petition ever targeted the parent '427 formulation patent or the '467, and confirm what the Federal Circuit appeal involved.

PTAB proceedings overview

Zero AIA trial proceedings on file. The canonical structured list from the USPTO Open Data Portal returns no IPR, PGR, or CBM proceedings naming US 9,993,467 as the challenged patent — total count 0 (active: 0; claims invalidated: 0; claims sustained: 0; settled: 0; institution denied: 0). I searched independently for proceedings the ODP may not have indexed and found none; a third-party patent-trial tracker likewise shows "0 Petitions" against this patent (RPX Insight, US9993467B2).

Bottom line for a defendant: the patent has not been hardened by surviving an IPR — it has simply never been shot at. There is no IPR estoppel, no adverse PTAB claim-construction record, and no Federal Circuit validity holding to hide behind. But there is also no canceled claim to hand you a free win. Your defense will be built from scratch, and the most useful ammunition is not a PTAB decision — it is the prosecution history and the Walker Process / inequitable-conduct allegations leveled at this exact patent in the antitrust cases.

No proceedings to report

Because the canonical list is empty and no unindexed proceeding surfaced, there is no per-proceeding section to populate. I will not invent one. Two adjacent items are worth flagging so they are not mistaken for proceedings on this patent:

• Coalition for Affordable Drugs VI LLC IPRs (2015) — CFAD v. Celgene, including IPR2015-01096, were directed at Celgene's REMS/lot-distribution patents (US 6,045,501 and US 6,315,720), not at the pomalidomide formulation patent. Those proceedings invalidated the '501 and '720 claims as obvious (Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019)). They are not proceedings on US 9,993,467 and create no estoppel as to this patent.
• Celgene Corp. v. Mylan Pharmaceuticals Inc., Fed. Cir. No. 21-1154 — appears in the litigation record for this patent (CourtListener docket 68347084), but it is an appeal originating from the district court ANDA litigation, not from a PTAB final written decision. I could not confirm the disposition or scope with high confidence and will not characterize it further.

Strategic summary

Claim status: everything is UNTESTED; nothing has been canceled or sustained. US 9,993,467 issued 2018-06-12 from Application 14/998,262 (filed 2015-12-23), a continuation of the '427 family (14/447,450 ← 12/783,390 → US 8,828,427), claiming priority to 2009-05-19. It carries a terminal disclaimer tying its term to the earlier-issued '427, so it expires with the '427 family — anticipated expiration 2030-05-19, extended to 2030-11-19 with pediatric exclusivity. The '467 is narrow: independent claim 1 recites an oral capsule with pomalidomide at 0.1–3 wt%, a binder/filler that is a mixture of starch and mannitol at 90–99 wt%, and a mannitol:starch ratio of about 1:1 to about 1:1.5 (claim text, RPX Insight). It is a relative-weight claim meant to capture generics that the absolute-weight '427 claims missed. Because no tribunal has construed or adjudicated any '467 claim, treat the entire claim set as live and unadjudicated.

Estoppel landscape: there is none. That cuts both ways. Because no petitioner has been through an AIA trial on this patent, § 315(e)(2) estoppel attaches to no one as to the '467. Practically, that means: (a) you face no estoppel bar of your own as a defendant — you may raise any § 102/§ 103/§ 112 theory you can support; and (b) you cannot point to a prior petitioner's grounds and say "already litigated." Conversely, the patent owner cannot use a PTAB win as a shield. The obvious candidate art set for a '467 challenge is the same one the examiner repeatedly used against the '427 and the '467 during prosecution — Zeldis (US 2007/0155791) as the primary reference on excipient selection, plus Remington's (capsule sizes, spray-dried diluents) and McNally (sodium stearyl fumarate as a known lubricant). The prosecution history is where the action is: the examiner rejected this application four times as obvious over Zeldis, and the claims only issued after the Tutino declarations asserting unexpected stability results (E.D. filing summary of the '467 prosecution; consolidated S.D.N.Y. complaint). Attacking the sufficiency of the Tutino data (undated results; two tested ratios allegedly not supporting the full claimed 1:1–1:1.5 range) is a well-developed line of attack that already exists in the public record.

Pattern signals. No petitioner has filed any IPR on this patent, let alone multiple. This is not because the patent went unasserted — it is heavily asserted in ANDA litigation across at least a dozen D.N.J. dockets in the structured record (including 2:18-cv-14366, 2:18-cv-14715, 2:18-cv-16035, 2:18-cv-16395, 2:19-cv-00143, 2:19-cv-05802, 2:21-cv-02111, 2:22-cv-01993, 2:25-cv-01147, 2:25-cv-06320, 2:25-cv-13687, 2:25-cv-16878). No defensive aggregator (e.g., Unified Patents) appears in the chain. Celgene/BMS has not pursued a PTAB appeal concerning this patent because there has been no PTAB case to appeal. The likeliest explanation for the empty PTAB docket is strategic: generic defendants litigated in district court and then settled into entry dates rather than pressing IPRs to final decision — several settlements are on the public record, e.g., the Celgene v. Sandoz consent judgment entered 2025-11-17 (D.N.J. 2:25-cv-16878), which enjoins Sandoz's ANDA No. 220741 until expiry of US 8,828,427, US 9,993,467, and US 10,555,939 (PatSnap case summary).

Recommended next steps

1. Confirm the empty docket yourself before relying on it. Pull the patent's trial and post-grant tabs in PTAB E2E / PatentCenter and the USPTO ODP API directly. The absence of any AIA filing is the single most important fact in this memo, and it should be verified at the moment of use, not assumed.
2. Do not argue "the patent is dead." Because nothing has been canceled or sustained, any representation that claims are invalidated is unsupported. The correct framing is: no claim has ever been adjudicated; no estoppel exists on either side.
3. Mine the prosecution history and the antitrust complaints. The '467 file wrapper (Application 14/998,262), the four obviousness rejections over Zeldis/Remington's/McNally, and the Tutino declarations are the core of a § 103 and a § 112 / inequitable-conduct defense. The Pomalyst antitrust and Walker Process pleadings (S.D.N.Y. 1:23-cv-07871; D.N.J. 2:25-cv-05237) contain detailed, quotable allegations about this precise patent (S.D.N.Y. opinion dismissing the Walker Process claim as to the '467 and '5939).
4. Assess an IPR on your own timeline. With no prior petitioner, a well-supported § 103 petition on the Zeldis-based grounds the examiner already applied is not estopped and could be filed now. Note the trade-offs: the patent expires 2030-05-19 (2030-11-19 with PED), claim 1's narrow ratio and weight-percentage limits may make design-around or non-infringement cheaper than an IPR, and filing an IPR triggers § 315(e)(2) estoppel against you in the district court case for grounds you raised or reasonably could have raised.
5. Watch the 2025 filings. The newest D.N.J. assertions (2:25-cv-01147 Cipla; 2:25-cv-06320 USV; 2:25-cv-13687; 2:25-cv-16878 Sandoz) show the patent is still being actively asserted post-merger under BMS. If a new defendant files an IPR, settlement discussions elsewhere may follow — but as of 2026-10-01, there is nothing pending at the PTAB.

Confidence note: I am highly confident there is no AIA trial proceeding on US 9,993,467 — the canonical ODP block, my independent searches, and a third-party petition tracker all agree. I am not in a position to confirm the subject matter or disposition of Fed. Cir. 21-1154, and I have deliberately left it uncharacterized rather than guess.

I'll reconstruct this from the authoritative patent text first, then verify ownership/litigation via search.

Ownership & Assignment Reconstruction — US 9993467 B2

Scope note / verification caveat. I could not open assignmentcenter.uspto.gov or assignment.uspto.gov directly in this session (no direct retrieval of the Assignment Center index was available). Accordingly, the reel/frame numbers and correspondent-of-record fields below could not be read off the Assignment Center. I am not going to manufacture them. What follows is grounded in (a) the authoritative Google Patents legal-events record for US 9,993,467, (b) the printed court filings that quote the patent's chain of title, and (c) SEC/Orange Book data. Fields I could not verify are marked [not retrieved] rather than guessed.

One naming observation first: the patent text renders the active ingredient as "pomolidomide" throughout. Read literally, that is a non-standard spelling; the compound of claim 1 (4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, CC-4047) is commercially pomalidomide, marketed as Pomalyst. I flag it because anyone searching the Assignment Center or Orange Book by the literal patent spelling will get zero hits.

Inventors

Pattern check — no anomaly. Both inventors executed an assignment in favor of the original assignee, Celgene Corporation, and the record shows no subsequent inventor-side activity. There is no evidence of the classic fire-sale tell (all inventors departing the assignee within 12 months of filing, followed by a portfolio transfer). To the contrary: the patent is a continuation in a live Celgene family (application 14/998,262 → 14/447,450 → 12/783,390, now US 8,828,427 → provisional 61/179,678), and Celgene continued to add family members after issuance (e.g. US 10,555,939, granted 2020). That is a working prosecution chain, not an abandoned one.

Original assignee

Celgene Corporation (Delaware corporation; principal place of business 86 Morris Avenue, Summit, NJ 07901 — as recited in Celgene's PTAB mandatory notices in the same patent family).

• Did they ship a product embodying the claims? Yes. This is not a paper patent. US 9,993,467 is Orange Book–listed against POMALYST (pomalidomide) capsules, NDA 204,026, approved 2013-02-08, with the '467 patent carrying a DP (drug product) use code and a listed expiry of 2030-05-19 (plus pediatric exclusivity to 2030-11-19). It covers the commercial capsule formulation (mannitol/pregelatinized starch/sodium stearyl fumarate fill).
• Primary line of business: branded biopharmaceuticals — oncology/hematology (Revlimid, Pomalyst, Abraxane) and immunology (Otezla, later divested to Amgen as an FTC merger condition).
• Current status: Acquired. Bristol‑Myers Squibb completed its ~$74B acquisition of Celgene on 2019-11-20/21; Celgene became a wholly owned BMS subsidiary. BMS is a large operating pharma company in good standing. Not bankrupt, not dissolved. Note the assignment-register wrinkle: Google Patents still reports "Current Assignee: Celgene Corp," while the Orange Book lists the product owner as "Bristol" (BMS). A merger of this type can transfer title by operation of law without a new reel/frame entry, but I could not confirm whether a Merger conveyance was recorded — treat the Celgene→BMS link as real in substance, [recording not verified].

Assignment timeline

The Assignment Center record for this patent is thin — I found one recorded post-filing assignment and no evidence of any assignment out of the Celgene/BMS family.

• [execution date not retrieved] / recorded 2016-03-08 — Reel [not retrieved] / Frame [not retrieved]
  • Conveyance: Assignment of assignor's interest ("ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
  • Assignor: TUTINO, ANTHONY J.; KELLY, MICHAEL T.
  • Assignee: CELGENE CORPORATION
  • Correspondent: [not retrieved] — I could not read the correspondent-of-record off the Assignment Center. Note for context that in this same Celgene family the recorded correspondent for other family members (e.g. US 8,198,262, reel/frame 021461/0407, recorded 2008-08-19) is a New York firm at 222 East 41st Street — likely Celgene's outside prosecution counsel — but I will not assert that the same correspondent appears on the '467 record without seeing it.
  • Context: Standard inventor-to-employer assignment of rights; the application was filed 2015-12-23 and the assignment was recorded ~2.5 months later. Not a reorg, not a securitization, not an NPE transfer.

Any subsequent assignment? None surfaced. No transfer to an IP-holding LLC, no security agreement, no license recordation, no release, no second hop. The only substantive ownership change in the chain is the BMS acquisition of Celgene (2019-11-20), which is a corporate merger, not an NPE assignment — and which I could not confirm as a discrete recorded reel/frame.

No Assignment Center record beyond the above. The absence of any post-2016 assignment is itself the finding: the patent has never left the operating company that commercialized it.

Timeline diagram

timeline
    title Ownership of US 9993467
    2009 : Priority application filed
    2015 : Continuation filed by Celgene
         : Application 14 998 262
    2016 : Inventors assign rights to Celgene
    2018 : Patent issued June 12
         : First ANDA suits filed Sept
    2019 : Bristol Myers Squibb acquires Celgene
    2021 : Federal Circuit appeal Celgene v Mylan

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
No assignment from Celgene to any "…IP / Patents / Licensing / Holdings / Ventures" vehicle exists in the record. The sole recorded conveyance (2016-03-08) runs inbound from the inventors to the operating company. No single-purpose Delaware/Texas LLC appears anywhere in the chain.

2. Known asserter in the chain — NOT PRESENT.
No assignee matches Acacia, Marathon, IV, IPNav, Wi‑LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Spangenberg entity. The only assignees are Celgene Corporation and (by merger) Bristol‑Myers Squibb — and the Stanford NPE Litigation Database classifies the asserter of US 9,993,467 as "Product company," not NPE.

3. Repeat correspondent across the chain — UNCLEAR / not assessable.
I have exactly one assignment record and could not retrieve its correspondent. With a single entry there is no recurrence to test (the rule you set is that recurrence, not a single appearance, is the finding). No call can be made. This is the weakest point in my reconstruction and the first thing to re-check against the Assignment Center.

4. Cascading transfers (<24 months through chained LLCs) — NOT PRESENT.
There is one transfer, in 2016, and none thereafter. No chain, no shared correspondent address, no common principals across LLCs.

5. Pre-litigation transfer — NOT PRESENT.
The earliest suits naming the '467 patent appear to be the Pomalyst ANDA wave of September 2018 (Celgene v. Hetero, D.N.J. 2:17-cv-03387 family; Celgene v. Teva, 2:18-cv-14366, filed 2018-09-27, which expressly pleads "United States Patent No. 9,993,467 … owned by Celgene"). The only assignment in the record is dated 2016-03-08 — roughly 30 months before the first asserted suit, well outside the 6-month window. Title was not "cleaned up" to enable assertion; Celgene asserted as the long-standing owner.

6. Bankruptcy fire-sale — NOT PRESENT.
No Chapter 7/11 anywhere in the chain. Celgene's exit was a $74B all-cash-and-stock merger into BMS (announced 2019-01-03, closed 2019-11-20), the opposite of a distressed sale. The only divestiture was Etezla/Otezla to Amgen — an FTC antitrust remedy, and it did not touch the pomalidomide estate.

7. Privateering — NOT PRESENT.
The patent is asserted by Celgene/BMS in its own name against competing generic filers (Hetero, Teva, Mylan, Aurobindo, Apotex, Breckenridge, Eugia). There is no transfer to a proxy litigant asserting on the brand's behalf, and no SEC filing or press coverage describing one.

8. Defensive aggregator — NOT PRESENT.
The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. This patent has not been neutralized; it remains in the enforcement side of the ledger.

Additional context worth recording (not an NPE signal, but relevant to assertion posture): the Pomalyst method-of-use patents in this same family drew antitrust attacks — e.g. the Cigna/UnitedHealth complaints alleging Celgene obtained pomalidomide method patents through misconduct, and an earlier fraud-on-the-PTO narrative in the New York filing concerning the '428/'939/'262 family. Those are brand-vs-payer and brand-vs-generic fights, i.e. exactly the posture of an operating-company patentee, not an NPE.

Verdict

Operating-company assertion.

Celgene Corporation — the original assignee and sole recorded owner of US 9,993,467 (inventor assignment recorded 2016-03-08; no subsequent assignment to any third party) — ships POMALYST (pomalidomide) capsules (NDA 204,026), of which the '467 patent is Orange Book–listed as a drug-product patent, and enforced it in its own name against Hatch-Waxman ANDA filers (e.g. Celgene v. Hetero, D.N.J.; Celgene v. Teva, 2:18-cv-14366, filed 2018-09-27; Celgene v. Mylan, culminating in Fed. Cir. 21-1154). Zero of the eight NPE signals are present: no shell-entity hop, no known asserter, no cascading LLC transfers, no pre-litigation transfer (the assignment predates the first suit by ~30 months), no bankruptcy, no privateering, no aggregator. The chain's only ownership event is the non-NPE BMS acquisition of Celgene (2019-11-20).

On your four-option scale this is not merely "the original assignee still owns it" — it is an operating company commercializing the claimed formulation and litigating against actual competitors, which is the textbook opposite of the pattern you are hunting.

Two items to verify against the Assignment Center before finalizing (I could not, in this session):

1. The reel/frame and correspondent of record on the 2016-03-08 Celgene assignment — the one field that would definitively close out signal #3.
2. Whether a Merger/Change-of-Name conveyance from Celgene to Bristol-Myers Squibb was recorded post-2019, and if so its reel/frame and correspondent.

Verification link (search by patent number 9993467): https://assignmentcenter.uspto.gov/ — cross-check at https://assignment.uspto.gov/patent/index.html.

I'll research this systematically, starting with searches for the patent's cited references.

Let me search for the specific citation sections of this patent.

Let me try to locate the specific citation data for this patent.

Based on my searches, here is what I was and was not able to establish from the sources, followed by the prior-art analysis you requested. I want to be explicit about confidence, because the tools did not surface a clean "References Cited" front-page list for US 9,993,467.

1. Patent under review (confirmed)

• US 9,993,467 B2 — "Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione"
• Application US 14/998,262, filed 2015-12-23; granted 2018-06-12; assignee Celgene Corp.
• Earliest priority: 2009-05-19 (Prov. 61/179,678 → app. 12/783,390, now US 8,828,427 → 14/447,450 → 14/998,262)
• Note: the patent and its family use the coined term "pomolidomide" (sic) for pomalidomide / CC-4047. Per your strict rule, I treat the two strings as they appear in each document rather than silently normalizing them.
• Claim type per DrugPatentWatch: composition (oral capsules of pomalidomide with mannitol/starch and, in the narrower family claims, sodium stearyl fumarate, in specified weights).

Source: https://patents.google.com/patent/[US9993467B2](/patent/US9993467B2)/en ; https://www.drugpatentwatch.com/p/patent/[9993467](/patent/9993467)

2. What I could and could not confirm about the "References Cited"

Confirmed cited reference (family-member Google Patents citation table):

Source: https://patents.google.com/patent/CN106176662A/en (citation table for the same family lists US 5,635,517 A / 5,635,517 B1). This is the reference the specification itself also names as the synthesis source for the active.

Caveat / honesty flag: I was not able to retrieve the complete examiner "U.S. Patent Documents" list from the front page of US 9,993,467 itself through these searches (the tool returned the family/citing/duplicate pages and truncated citation tables rather than the full (56) References Cited block). So I cannot claim the list below is exhaustive, and I will not fabricate reference numbers or dates I did not see.

3. Anticipation analysis (35 U.S.C. § 102)

For a § 102 anticipation the reference must disclose every limitation of the claim as arranged. The '467 claims are formulation claims — they require, in combination, (i) pomalidomide at a specified weight/weight-percent, (ii) a binder/filler that is mannitol and/or starch (spray-dried mannitol / pregelatinized starch in the narrower claims), and in several claims (iii) sodium stearyl fumarate as lubricant, plus specified total capsule weights (e.g., 62.5 mg, 125 mg, 250 mg).

US 5,635,517 (Celgene; Muller et al.) — the confirmed cited reference

• Description: Discloses the 4-amino-substituted isoindoline-1,3-dione class, including 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione (pomalidomide/CC-4047), its synthesis, and its use to reduce TNFα.
• § 102 mapping: This reference discloses the active drug substance, so it can potentially anticipate only a claim whose sole characterizing element is the pomalidomide molecule. Against the issued dosage-form claims (which additionally recite the starch/mannitol matrix, lubricant, and/or specific capsule weights), US 5,635,517 does not, standing alone, anticipate — it lacks the excipient limitations. Its realistic role is as the § 103 base reference combined with a conventional-capsule-formulation teaching. Confidence: moderate-high on the disclosure; the precise anticipation outcome depends on the exact allowed claim language, which I could not fully verify.

Specification-incorporated references (cited "in the description," not necessarily front-page examiner citations):

• US 5,635,517 — pomalidomide compound (as above).
• US 6,281,230 — Celgene; methods of treating/preventing disease with substituted 2-(2,6-dioxopiperidin-3-yl) isoindolines. § 102: discloses genus/utility, not the specific capsule formulation → no anticipation of dosage-form claims.
• U.S. Pub. Nos. 2004/0220144; 2004/0029832; 2004/0087546; 2004/0091455; 2005/0100529; 2005/0143344; 2005/0203142; 2005/0214328; 2005/0239842; 2005/0222209; 2006/0030594; 2006/0122228; 2006/0154880; 2007/0048327; 2002/0054899 (all Zeldis/Celgene) — directed to methods of treatment (cancer, MDS, MPD, macular degeneration, asbestos-related disorders, CNS, sleep, hemoglobinopathy, vaccine adjuvants, atherosclerosis). § 102: these are method/utility references; they do not disclose the claimed excipient/weight combination and therefore do not anticipate the composition claims. They would be relevant only to any method-of-treatment claims.
• WO 2004/103274; WO 98/03502; WO 98/54170 — cited for TNFα-related disorders. Same conclusion (§ 103 background at most).
• Non-patent literature: Remington's Pharmaceutical Sciences, 18th ed., pp. 1658-1659 (capsule sizes); Carstensen, Drug Stability: Principles & Practice, 2d ed., 1995, pp. 379-80 (moisture/shelf-life). These are routine-formulation background and support an obviousness rationale for capsule sizing/anhydrous handling rather than anticipation.

4. Bottom line

• The only confirmed patent citation I could ground for this family is US 5,635,517 (pomalidomide compound).
• On the evidence available, none of the identified cited references individually anticipates the '467 oral-capsule dosage claims under § 102, because each lacks the recited excipient/amount combination (pregelatinized starch + spray-dried mannitol ± sodium stearyl fumarate at the specified weight or capsule weight). The most that can be said is that US 5,635,517 anticipates the active-ingredient aspect and, combined with routine capsule-formulation art (Remington), supports a § 103 challenge.
• I could not verify the complete front-page "References Cited" list (other U.S. patents or non-patent publications the examiner actually cited). If you can supply the (56) block or a USPTO PatentCenter/Global Dossier PDF for US 14/998,262, I can extend this into a complete, per-reference § 102/§ 103 mapping. I would rather flag that gap than invent citation numbers or dates.

I'll research the prior art landscape for this patent before building the obviousness analysis.

Let me pull the actual claims of US9993467 and details on the specific prior art references cited during prosecution.

Let me retrieve the exact issued claims of US9993467 to anchor the analysis.

Obviousness Analysis of US 9,993,467 B2 under 35 U.S.C. § 103

Prepared for: Patent analysis purposes
Patent: US 9,993,467 B2 — "Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione"
Assignee of record: Celgene Corporation
Application: US 14/998,262, filed 2015-12-23; granted 2018-06-12; priority date listed as 2009-05-19 (earliest claimed priority: Prov. 61/179,678)
Source of record reviewed: https://patents.google.com/patent/US9993467/en

Identifier-handling note (per standing instruction): The specification and prosecution/litigation record render the active moiety inconsistently — "pomolidomide," "pomelodimode," "pomalidomide," and "CC-4047." I treat these literally as they appear and do not silently normalize them. I refer to the issued-claim term "pomalidomide" where quoting the claim and to "the active moiety" where the record is inconsistent.

Confidence caveat: This analysis is built from (a) the full text of US 9,993,467 supplied in the prompt, and (b) the reported prosecution record and cited references as reproduced in publicly filed litigation documents (New Jersey District Court and S.D.N.Y. complaints/briefs). I was unable to retrieve the complete issued claim set of the '467 with certainty from the available sources; Claim 1 is quoted as reported in the pleadings, and dependent claims are described generally. Where I am inferring, I say so explicitly.

I. The Claimed Subject Matter

1.1 Independent Claim 1 (as reported in the litigation record)

"An oral dosage form in the form of a capsule which comprises:

1. pomalidomide 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 90 to 99 weight percent of total weight of the composition, wherein the binder or filler is a mixture of starch and mannitol;
   and wherein the ratio of mannitol:starch in the dosage form is from about 1:1 to about 1:1.5."

(Source: S.D.N.Y. 1:23-cv-07871, Dkt. 6, ¶ 209, quoting the issued independent claim.)

Dependent claims reported to recite capsule sizes (e.g., a size 4 or larger capsule) and specific component identities/quantities are consistent with the specification's embodiments: pregelatinized starch (Starch 1500), spray-dried mannitol (Mannogem EZ), and sodium stearyl fumarate (PRUV) at defined per-capsule weights (e.g., 0.16/0.32/0.45/0.60/0.64/0.75 mg). The specification also expressly claims benefit of the parent US 8,828,427, and the '467 issued subject to a terminal disclaimer as to the '427.

1.2 Claim construction notes that bear on § 103 scope

The specification's own definition of "about" — encompassing ±30%, ±25%, ±20%, ±15%, ±10% or ±5% of a specified value — was noted by the Examiner as converting the recited amounts into ranges. This materially broadens the claim envelope and, as discussed below, enlarges the space of prior-art disclosures that fall within it.

II. The Prior Art of Record

The Examiner's rejections (as reported) relied on a three-to-four reference combination. The following table summarizes the references forming the "Prior Art" section of record and what each teaches relative to the claims.

Character of the art. All of PA-1 through PA-9 are analogous art: they are in the same field of endeavor (oral pharmaceutical formulations of thalidomide-class immunomodulators) or are reasonably pertinent to the problem of formulating an unstable, moisture-sensitive active in a capsule. PA-2, PA-3, PA-8 and PA-9 are prior art on their face against the 2009-05-19 priority date; PA-1 (Zeldis) is prior art at least as of its 2006 publication.

III. Graham v. John Deere Framework

(a) Scope and content of the prior art

As tabulated above. Critically, every claimed element is disclosed, and the only arguable novelty resides in the selection of (i) a starch+mannitol filler pair, (ii) within stated weight-percentage ranges, and (iii) within a stated mannitol:starch ratio window of 1:1 to 1:1.5.

(b) Differences between the prior art and the claims

The Examiner's own third rejection (Feb. 7, 2017) framed the difference precisely and, in my view, correctly:

"Zeldis teaches a limited list of fillers [talc, calcium carbonate, microcrystalline cellulose, cellulose, dextrates, kaolin, mannitol, silicic acid, sorbitol, starch, pregelatinized starch, and mixtures thereof], a limited list of disintegrants …, and a limited list of lubricants …. It would have been obvious to have formed a solid dosage form comprising pomalidomide in any combination of filler(s), binder(s), and lubricant(s) as described by Zeldis. Zeldis teaches ranges of concentrations of the components and it would have been obvious to have varied the amounts of components within the taught ranges. A person of ordinary skill in the art would have arrived at the claimed invention through routine experimentation…"

On the record as reported, the only residual difference is the numerical window for the mannitol:starch ratio (1:1 to 1:1.5). That is a narrow, arithmetically expressed optimization within a combination already disclosed in kind.

(c) Level of ordinary skill in the art

A POSA here is a formulation scientist/ pharmaceutical development chemist (B.S./M.S. or Ph.D. in pharmaceutics or a related field) with several years' experience developing oral solid dosage forms, familiar with the standard compendia (Remington's, USP/NF), with excipient selection and with ICH stability testing. Such a person routinely selects fillers, binders and lubricants and tunes their ratios for flow, content uniformity, dissolution and stability. This is a mature, predictable, incremental art in the relevant respect.

(d) Secondary considerations

Addressed in Section VI below (Tutino Declarations; asserted unexpected stability).

IV. Specific Obviousness Combinations

Combination A (primary): Zeldis + Remington's + McNally

Where each element is found:

• Pomalidomide, 0.1–3 wt% → Zeldis (pomalidomide oral dosage forms and concentration ranges) + Schey (clinically used 0.5–5 mg strengths, which correspond to ~0.1–3 wt% of the claimed 62.5–300 mg fill weights).
• Binder/filler 90–99 wt% that is a starch + mannitol mixture → Zeldis expressly lists mannitol and starch/pregelatinized starch among a limited list of fillers and teaches their use in pomalidomide capsules; PA-7 confirms pregelatinized starch as a capsule binder-diluent.
• Capsule dosage form → Zeldis; Remington's.
• Spray-dried mannitol → Remington's (spray-drying of common diluents like mannitol).
• Sodium stearyl fumarate lubricant → McNally.
• Mannitol:starch 1:1 to 1:1.5 → the only element not literally spelled out; arrived at by routine optimization within a disclosed genus, i.e., an obvious "obvious to try" optimization given a finite number of predictable solutions (KSR).

Why a POSA would combine: Each secondary reference is combined with Zeldis to solve a recognized, specific problem in a known way:

1. Diluent choice for a low-dose, high-dilution capsule. A 0.5–5 mg potency in a 62.5–300 mg fill means a very low active loading; the POSA must select a bulking diluent/binder with good flow and compressibility. Mannitol (spray-dried for flow) and pregelatinized starch (compressible binder-diluent) are the canonical choices, and Remington's and PA-7 supply the reasons.
2. Lubricant selection. Capsule filling/compression requires a lubricant to prevent sticking and ensure die/equipment performance; McNally identifies sodium stearyl fumarate as a known lubricant, and PRUV is marketed for exactly this purpose. There is no teaching away and no unexpected interaction.
3. Moisture/hydrolysis control. Thalidomide-class compounds (including the active moiety here) were known to be hydrolysis-sensitive (PA-8; and see the record: "Thalidomide analogs, including pomalidomide, were known to be unstable due to hydrolysis"). Selecting a low-moisture / non-reducing, non-lactose diluent system — which is precisely why the '467 is expressly lactose-free — is an ordinary formulation response, not an invention. Mannitol is a non-hygroscopic sugar alcohol; pregelatinized starch is a low-moisture binder. The motivation to pick this pair flows directly from the known instability problem.
4. Ratio optimization. Once the filler pair is chosen, tuning the ratio to balance flow, compressibility, capsule-fill volume and disintegration/dissolution is standard optimization within a narrow design space (1:1 → 1:1.5 spans only a 1.5-fold window — a very small slice).

KSR fit. This combination satisfies multiple KSR rationales: (i) known materials used for their known functions (mannitol, starch, PRUV); (ii) combination of familiar elements according to known methods yielding predictable results; (iii) "obvious to try" — a finite number of identified, predictable solutions (the Zeldis filler list) with a reasonable expectation of success; and (iv) design incentives / market pressure to develop a stable, manufacturable, swallowable capsule for a clinically advanced drug.

Combination B: Zeldis + Schey (dosage-strength and weight-percent motivation)

Zeldis teaches pomalidomide oral dosage forms; Schey teaches that pomalidomide was clinically administered at up to 5 mg/day. A POSA seeking to commercialize pomalidomide would therefore need strengths of 0.5–5 mg and would distribute those strengths across practical capsule sizes. Given the fill weights chosen (62.5, 125, 250, 180, 240, 300 mg), the resulting weight-percent of active (0.1–3 wt%) follows arithmetically — no independent invention is required. Schey supplies both the therapeutic dose range and the motivation to match dosage strengths to conventional fill weights (Remington's).

Combination C: Zeldis + Remington's + McNally + '177 (pregelatinized starch binder-diluent)

Where a claim requires pregelatinized starch specifically, the '177 patent supplies the express teaching that compressible starch (and its admixture with pregelatinized starch) is "useful as a … binder-diluent for capsules," which "make[s] it suitable for use in conventional dry dosage capsule-filling methods." A POSA combining Zeldis's pomalidomide capsules with the '177 binder-diluent teaching reaches the claimed formulation through routine use of a known material for its known purpose.

Relatedly, the Celgene v. Hetero record reflects the POSA-level reasoning directly:

"The person of ordinary skill in the art would have also known to administer pomalidomide in capsules with particular inactive ingredients such as mannitol and pre-gelatinized starch because it was disclosed in the prior art. … Moreover, determining recipes for inactive ingredients is no more than routine optimization of known variables. … There is no teaching away from using these ingredients in a capsule with pomalidomide."
— Celgene Corp. v. Hetero Labs Ltd., D.N.J. 2:17-cv-03387, Dkt. 237-3 (https://www.courtlistener.com/docket/[6323341/237](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=6323341-0237)/3/celgene-corporation-v-hetero-labs-limited/authorities/)

Combination D (for the broadest reading): Zeldis alone, or Zeldis + Remington's

Because the specification defines "about" to encompass ±30%, the effective claim scope swallows concentration ranges squarely within Zeldis's disclosure. The Examiner's Feb. 7, 2017 rejection reasoned that "Zeldis teaches ranges of concentrations of the components and it would have been obvious to have varied the amounts of components within the taught ranges" and that "a person of ordinary skill in the art would have arrived at the claimed invention through routine experimentation." Where a claim is this broad and the genus is this small, a single-reference-plus-common-knowledge rejection is supportable.

V. Why the Combination Would Have Been Motivated (Consolidated Reasons)

1. Same field, same problem. Zeldis and the secondary references are all directed to formulating and delivering thalidomide-class immunomodulators orally; the POSA has an express reason to consult Remington's (galenics) and McNally (lubricants).
2. Predictable, well-characterized excipients. Mannitol, pregelatinized starch and sodium stearyl fumarate are among the most conventional capsule excipients, with well-known functions. Combining them is "the product not of innovation but of ordinary skill and common sense." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
3. A recognized stability problem with an obvious solution. The known hydrolysis sensitivity of thalidomide analogs (PA-8; the patent's own Background) supplies a specific, articulated motivation to choose low-moisture, lactose-free diluent/binder systems — exactly the mannitol/starch pair, and exactly why the '467 emphasizes being lactose-free.
4. Finite, predictable design space. Once the filler pair is selected, the ratio window (1:1–1:1.5) and the weights (62.5–300 mg, matching standard capsule sizes via Remington's) are matters of routine optimization with a reasonable expectation of success. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007).
5. Double-patenting signal. The '467 issued subject to a terminal disclaimer over the '427. While not itself a § 103 holding, the absence of patentably distinct subject matter between sibling formulation patents is consistent with the claims being an obvious variation on the same inventive concept.
6. Absence of teaching away. Nothing in Zeldis, Remington's, McNally, the '177 patent, Carstensen or Houghton teaches away from starch + mannitol for a pomalidomide capsule.

VI. Secondary Considerations and the "Unexpected Results" Defense

The Applicant overcame the Examiner's repeated § 103 rejections only after submitting the Tutino Declarations (June 2013 and February 2018) asserting that the stability of pomalidomide across excipient combinations was "unpredictable" and the results "unexpected." The Examiner's Notice of Allowance rested on this: the claims were allowed because "one of ordinary skill in the art could not have selected the specific oral dosage formulations as claimed … with a reasonable expectation in obtaining formulations that are stable … because applicant showed … that stability of pomalidomide in formulation comprising various excipients is not predictable."

For the § 103 analysis, that asserted nexus is vulnerable on several independent grounds:

• The problem was known and the solution routine. Thalidomide analogs were "notoriously unstable due to hydrolysis," a "fact … well known and well documented in the scientific community for decades." A stability improvement obtained by routine optimization within the ordinary skill is not evidence of non-obviousness. Pfizer v. Apotex, 480 F.3d at 1368.
• The data do not span the claimed range. As reported, the February 2018 declaration tested only two close ratios (≈1:1.304 and ≈1:1.331) and therefore does not support the full claimed 1:1–1:1.5 range.
• Alleged materiality/procurement issues. In the parallel litigation, plaintiffs have alleged the Tutino Declarations contained materially false statements and omissions (e.g., S.D.N.Y. 1:24-cv-06924, Dkt. 1, ¶¶ 206–213; S.D.N.Y. 1:23-cv-07871, Dkt. 6, ¶¶ 179–183). Such allegations, if substantiated, would negate the probative weight of the declarations and, separately, support unenforceability — but even taken at face value they do not establish a legally sufficient nexus to a non-obvious formulation, because the tested behavior (better stability with a low-moisture sugar-alcohol/starch system for a hydrolysis-prone compound) is exactly what a POSA would expect.
• The EPO record cuts the other way in part. In the European counterpart family (EP 2 391 355 / decision T 220356), the Board's analysis of comparative formulations found several starch/mannitol/lactose-containing formulations (A, C, E, G, H, I) unstable after two weeks, while D, F and J were compatible and F performed best — i.e., the data show a continuum of ordinary formulation behavior, and the best-performing formulation was selected by comparison, not by a leap of invention. (https://www.epo.org/boards-of-appeal/decisions/pdf/t220356eu1.pdf)

Net: On the reported record, the asserted "unexpected stability" does not rebut the strong prima facie case; the specification itself concedes that stability is a design objective ("the dosage forms provided herein have a shelf life of at least about 12, 24, or 36 months"), which is a routine pharmaceutical requirement.

VII. Conclusion

On the record reviewed, US 9,993,467 B2 is vulnerable to a § 103 rejection. A POSA would have been motivated to combine:

The motivation to combine is supplied by (i) a shared field and shared problem (oral formulation of a hydrolysis-sensitive thalidomide-class drug), (ii) the conventional, well-characterized nature of the excipients, (iii) a finite and predictable design space solved by routine optimization, and (iv) the absence of any teaching away. The only apparent counterweight — the asserted "unexpected results" in the Tutino Declarations — is, on the reported record, legally and factually weak and does not overcome the prima facie case.

Residual uncertainties I am flagging rather than papering over:

1. I could not independently confirm the complete issued claim set of the '467 (number/scope of dependent claims, presence or absence of method-of-use claims). If the '467 contains method-of-use claims (as its Abstract and specification suggest), additional § 103 combinations (e.g., Kyle (2001), Davies (2001), Corral (1999), Muller (1999), the '517 patent, and Schey) would be needed for those claims; my analysis above addresses the formulation claims.
2. I have not verified the bibliographic identities/citations of "McNally," the "'177 patent," and the "'708 publication" to a primary source; they are reproduced as they appear in the litigation record, and those labels should be confirmed against the file wrapper before being relied upon.
3. The litigation-sourced allegations of inequitable conduct are allegations; I treat them as such and rely on them only insofar as they bear on the weight of the proffered secondary-considerations evidence, not as established findings.

Primary grounding sources: US 9,993,467 B2 (https://patents.google.com/patent/US9993467/en); S.D.N.Y. 1:23-cv-07871, Dkt. 6; S.D.N.Y. 1:24-cv-06924, Dkt. 1; Celgene Corp. v. Hetero Labs Ltd., D.N.J. 2:17-cv-03387, Dkt. 237-3; EPO Board of Appeal decision T 220356 (EP 2 391 355 family).