US 8198262

I'll search for authoritative information on US 8,198,262, including any 2026 CAFC activity, then summarize.

Let me check specifically for any 2026 Federal Circuit docket activity involving this patent.

Let me confirm the exact claim set and check for any 2026 Federal Circuit activity tied to this patent number.

US 8,198,262 B2 — Analyst Summary

Method note / caveat up front: My searches were run through a web-search tool, not a direct authenticated query against USPTO Patent Center or the CAFC CM/ECF docket. The bibliographic data below is corroborated across Google Patents, the FDA patent-term-extension record, and litigation filings. I did not find any 2026 Federal Circuit docket entry specific to US 8,198,262. The Federal Circuit activity I did locate for this patent is the 2021 appeal Celgene Corp. v. Mylan Pharmaceuticals Inc., No. 21-1154 (venue/pleading issue; affirmed), which is a 2021–2022 matter, not 2026. I flag the 2026 question as unresolved rather than assert a null result as fact.

1. Bibliographic Data

Date discrepancy worth flagging. The sources do not agree on the expiry date:

• Google Patents shows "expires 2025-04-23."
• The USPTO notice of final determination and the Orange Book both show original expiry October 19, 2024, extended by 241 days to June 17, 2025 (with pediatric exclusivity listed to December 17, 2025).

I am reporting both rather than reconciling them. There is likewise a priority-date tension: Google Patents states 2002-05-17, while the Pomalyst antitrust/inequitable-conduct complaints trace the '262 family to a November 6, 2002 provisional (60/424,600). I do not have authoritative confirmation of the operative priority chain.

2. Abstract (as issued)

"Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed."

Analyst observation: The abstract and specification are markedly broader than the title and the claims. The title and claims are directed to one compound (pomalidomide) for multiple myeloma; the abstract and disclosure recite a genus of "immunomodulatory compounds" and a laundry list of cancers and angiogenesis-mediated disorders. This breadth mismatch is typical of the Celgene IMiD family and is a recurring theme in the litigation.

3. The Compound

4-(Amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione = pomalidomide (Celgene "ACTIMID™"; marketed as POMALYST®), CAS 19171-19-8, InChI key UVSMNLNDYGZFPF-UHFFFAOYSA-N. The specification expressly states that the immunomodulatory compounds of the invention "do not include thalidomide," and distinguishes the compound from REVIMID™ (lenalidomide).

4. Independent Claims — Plain Language

The '262 has two independent claims (1 and 20), each a method-of-treatment claim; claims 2–19 depend from claim 1 and claims 21–27 depend from claim 20.

Claim 1 — A method of treating multiple myeloma by administering, to a patient who has it:

• (a) pomalidomide (or a pharmaceutically acceptable salt, solvate or stereoisomer) at about 1 mg to about 5 mg per day, given for 21 consecutive days followed by 7 consecutive days of rest, in a 28-day cycle; and
• (b) 40 mg of dexamethasone.

Claim 20 — A method of treating multiple myeloma by administering, to a patient who has it:

• (a) pomalidomide for 21 consecutive days followed by 7 consecutive days of rest in a 28-day cycle; and
• (b) 40 mg of dexamethasone on at least one of days 1–21 of that cycle.

Notable dependent claims:

So in substance: the '262 is a narrow, specific dosing-regimen patent — pomalidomide 1–5 mg/day on a 21-on/7-off 28-day cycle plus 40 mg dexamethasone — notwithstanding the far broader specification.

5. Litigation and Enforcement Context (as reflected in the public record)

• The '262 was asserted in the Pomalyst ANDA wave in the District of New Jersey, including Celgene v. Hetero Labs (2:17-cv-03387), Celgene v. Mylan (2:17-cv-03159), Celgene v. Synthon (2:18-cv-10775), and a North Carolina Middle District action (1:18-cv-00540). Google Patents also lists 2:19-cv-05802, 2:21-cv-02111 and 2:22-cv-01993.
• CAFC No. 21-1154, Celgene Corp. v. Mylan Pharmaceuticals Inc. — venue and failure-to-state-a-claim; the Federal Circuit affirmed the dismissals.
• Claim construction: in Celgene Corp. v. Hetero Labs Ltd., the court addressed whether the preamble "a method of treating multiple myeloma" imposes an efficacy limitation, noting the parties agreed the '262, '428 and '3,939 patents share a common specification, and that the specification defines "treating" as administration after onset of symptoms.
• The '262 is one of the three "Zeldis Patents" (with 8,735,428 and 8,673,939) litigated as method-of-treatment patents; the '428 and '3,939 were filed March 1, 2013, as continuations in the '262 family, and terminal disclaimers were filed against the '262.
• Allegations, not findings: In putative class actions and antitrust complaints (e.g., The Cigna Group v. Celgene Corp.; the Pomalyst complaints filed in D.N.J. in 2023), plaintiffs allege the '262 was procured by inequitable conduct/fraud on the PTO — specifically misrepresentations about "unexpected results" and non-disclosure of prior art (Davies 2001, D'Amato 2001, Kyle 2001, Corral 1999, Muller 1999, Hideshima 2000, Lentzsch 2001/2002, Schey 2002, Coleman 2002, Cohen 1982), and reliance on the Thakurta and Tutino declarations. These are pleaded allegations; I have not located an adjudicated judgment invalidating or holding the '262 unenforceable.

6. Explicit Uncertainties

1. No 2026 CAFC docket activity for US 8,198,262 was found. Treat this as "not found in my searches," not as confirmed absence. Given the patent expired on or about June 17, 2025 (plus pediatric exclusivity), 2026 appellate activity concerning it is improbable but not impossible (e.g., collateral estoppel or damages tail issues).
2. Expiry date conflict (2025-04-23 vs. 2025-06-17 vs. 2025-12-17 with PED) — unresolved above.
3. Priority chain (2002-05-17 vs. 2002-11-06) — unresolved.
4. Assignment execution date of 2003-09-03 is reported in the FDA record although the assignment was recorded 2008-08-19 against the 12/229,074 filing; I have not verified the underlying document.
5. I did not fetch the USPTO file wrapper or Patent Center directly; all statements rest on the Google Patents text supplied plus search-retrieved FDA, Orange Book, PACER/CourtListener and litigation documents.

I'll research litigation involving US patent 8198262 using the search tools.

Let me search for the specific cases listed on the patent's litigation record.

Litigation Involving U.S. Patent No. 8,198,262

Patent identified: U.S. Patent No. 8,198,262 B2, "Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione," inventor Jerome B. Zeldis, assignee Celgene Corporation. Issued June 12, 2012; application No. 12/229,074; filed August 19, 2008. Claims a method of treating multiple myeloma with pomalidomide (POMALYST®) in a 28‑day cycle with dexamethasone. This is a method-of-use (ANDA/Hatch-Waxman) patent, not a compound patent.

⚠️ Important scope caveat: Google Patents' litigation panel for this patent links several cases, but I was not able to verify every listed docket number individually within my search budget. I distinguish below between (A) cases where I confirmed the '262 patent was actually asserted, and (B) cases listed on the patent's record that I could not fully verify — several of which may involve other Celgene patents or a different patent altogether (e.g., an unrelated "826" patent appears in PTAB shoe-sole proceedings and must not be conflated with 8,198,262).

A. Confirmed cases asserting the '262 patent

1. Celgene Corporation v. Synthon Pharmaceuticals, Inc.; Synthon B.V.; Synthon S.R.O.; and Alvogen Pine Brook, LLC

• Jurisdiction: U.S. District Court for the District of New Jersey (Newark)
• Case No.: 2:18-cv-10775 (ES)(MAH)
• Filed: June 19, 2018
• Cause: 35 U.S.C. § 271(e)(2) patent infringement (ANDA No. 210232, generic pomalidomide capsules 1/2/3/4 mg)
• Patents-in-suit (per the amended complaint/consent judgment): U.S. 8,198,262; 8,673,939; 8,735,428; 8,828,427; 9,993,467; 10,093,647; 10,093,648; 10,093,649
• Assigned judge: Hon. Esther Salas; Magistrate Judge Michael A. Hammer
• Outcome/status: Resolved amicably. A Consent Judgment was entered May 13, 2019, dismissing all claims and counterclaims with prejudice and permanently enjoining Synthon/Alvogen from infringing the patents-in-suit (including the '262 patent) until their expiration. Source: CourtListener docket 7221413; D.N.J. 2:18-cv-10775 (D.E. 50, 52). Case terminated 2019-05-13.

2. Celgene Corporation v. Synthon Pharmaceuticals, Inc.

• Jurisdiction: U.S. District Court for the Middle District of North Carolina
• Case No.: 1:18-cv-00540
• Filed: June 21, 2018
• Cause: 35 U.S.C. § 271 patent infringement
• Patents-in-suit: U.S. 8,198,262 ('262); 8,673,939 ('939); 8,735,428 ('428); 8,828,427 ('427) — per the complaint's Exhibits A–D
• Outcome/status: Case terminated July 25, 2018 on a Stipulation of Dismissal (D.E. 8) — a parallel/companion filing to the New Jersey action. Source: CourtListener docket 7248061.
• Note: The same docket number string (1:18-cv-00540-LMB-IDD) also appears in E.D. Virginia filings referencing jury instructions in March 2019 (gov.uscourts.vaed.387864). I could not confirm whether this reflects a transfer or a separate declaratory-judgment action; treat this point as unverified.

3. Celgene Corporation v. Hetero Labs Limited, et al. (docket also reported as Celgene Corp. v. [Dr. Reddy's Laboratories, Ltd.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Ltd.))

• Jurisdiction: U.S. District Court for the District of New Jersey
• Case No.: 2:17-cv-03387
• Filed: May 11, 2017
• Cause: 35 U.S.C. § 271 patent infringement
• Outcome/status: Terminated August 19, 2021. The '262 patent is listed among the patents in this action. Source: DrugPatentWatch patent-8,198,262 and patent-6,476,052 litigation indices; Stanford NPE litigation database (parties include Hetero, Aurobindo, Mylan entities).
• ⚠️ Discrepancy noted: sources conflict on the lead defendant/caption (Hetero vs. Dr. Reddy's) for this docket number. I am reporting both as found rather than auto-correcting.

B. Cases listed on the patent's litigation record that I could NOT fully verify

The Google Patents litigation panel for US 8,198,262 lists these additional matters (all involving the Celgene pomalidomide/Revlimid patent family). I was unable to pull confirmable details on each before exhausting my search steps:

C. Items I explicitly excluded (to avoid false matches)

• PTAB IPR involving a "'826 patent" (AOI v. Accelight, shoe-sole design) — this is a different patent, not 8,198,262, and the "826" shorthand refers to a dissimilar number.
• In re Revlimid and Thalomid Purchaser Antitrust Litigation, 2:19-cv-07532 (D.N.J.) and related Celgene antitrust/pay-for-delay, Walker Process, and sham-litigation matters — these concern Celgene's lenalidomide (Revlimid) and thalidomide (Thalomid) patents, not the pomalidomide '262 patent. I found no allegation that the '262 patent was part of that antitrust scheme.
• Mylan v. Celgene, Actelion v. Apotex, Lannett v. Celgene (sample-refusal litigation) — unrelated patents.

D. Related non-litigation proceedings (for completeness, not "litigation")

• Patent Term Extension (35 U.S.C. § 156): The '262 patent received a 241-day PTE based on NDA 204026 (POMALYST®), extending it to June 17, 2025 (original expiration Oct. 19, 2024). Celgene had to elect between the '262 patent and U.S. 6,316,471 for the same regulatory review period. Source: USPTO Notice of Final Determination.
• Orange Book: '262 was listed for NDA 204026 (POMALYST) with use codes U-1360 and U-2254; listed expiration June 17, 2025 (plus pediatric exclusivity noted to Dec. 17, 2025). The patent is now expired (Google Patents shows "Expired – Lifetime," adjusted expiration 2025-04-23).

Bottom line

The '262 patent was litigated as part of Celgene's Hatch-Waxman enforcement of POMALYST® against generic pomalidomide filers. The best-documented assertions are the Synthon/Alvogen actions (2:18-cv-10775 in D.N.J., ending in a May 13, 2019 consent judgment/injunction; and 1:18-cv-00540 in M.D.N.C., dismissed July 25, 2018) and 2:17-cv-03387 (D.N.J., terminated 2021). I could not independently verify the specifics of docket numbers 2:17-cv-03159, 2:19-cv-05802, 2:21-cv-02111, 2:22-cv-01993, or CAFC 21-1154 within the available searches — those remain listed on the patent record but unconfirmed. I did not find any plaintiff asserting the '262 patent against Celgene (i.e., no declaratory-judgment action confirmed on the '262 patent itself), and no damages verdict or invalidity holding concerning the '262 patent.

I'll start by verifying the absence of PTAB proceedings via web search, since the ODP block reports none.

Let me run additional targeted searches to confirm no AIA trial was ever filed on the '262 patent specifically.

Let me run a final verification pass focused on the PTAB docket and any Unified Patents or other third-party challenge.

PTAB / AIA Trial Proceedings — US 8,198,262 B2

Patent: US 8,198,262 B2 — Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione (pomalidomide; Celgene "ACTIMID"/POMALYST)
Inventor: Jerome B. Zeldis | Original assignee: Celgene Corp. | Filed: 2008-08-19 | Granted: 2012-06-12 | Priority: 2002-05-17
Canonical source: USPTO ODP "PTAB proceedings on file" block (none returned); Google Patents record — https://patents.google.com/patent/US8198262/en

Proceedings overview

Zero AIA trial proceedings are on file for US 8,198,262. The breakdown is 0 active, 0 claims invalidated, 0 claims sustained, 0 settled, and 0 institution denials. I ran independent web searches (Google Patents, CourtListener/PTAB E2E references, Celgene/BMS SEC disclosures, D.N.J. ANDA dockets) to look for unindexed or older proceedings, and none surfaced — the only Celgene PTAB matters documented in the record involve other patents (see "Non-PTAB context" below), not the '262. My search tooling was capped before I could exhaustively run a PTAB E2E docket query by patent number, so I flag that as the one residual verification gap; but the ODP default ("no PTAB activity") is corroborated, not contradicted, by everything I found.

Bottom-line defensive posture: There is no IPR-based invalidation to lean on. All 27 claims stand exactly as issued — nothing was canceled, nothing was confirmed through an AIA trial. The "hardened by IPR" framing does not apply here; equally, the "claims 1-5 are already dead" framing does not apply. Any obviousness/unenforceability attack must be made in district court (or the ITC), and the practical significance of an IPR is now largely academic because the patent expired in 2025 (see dates below).

Proceedings

No AIA trial proceedings exist to report. I am deliberately not creating entries — per your instruction not to invent proceeding numbers.

For completeness, here is the non-PTAB context that a defendant actually needs, clearly labeled:

District court / Federal Circuit overlay (NOT PTAB proceedings)

• Assertion history: The '262 was one of the core Pomalyst method-of-treatment patents asserted in the D.N.J. ANDA wave against Teva, Apotex, Hetero, Mylan, Aurobindo, Breckenridge, Natco, and Dr. Reddy's — e.g., Celgene Corp. v. Hetero Labs Ltd., No. 17-3387 (D.N.J.) (see the litigation links on the Google Patents page: 2:17-cv-03387, 2:17-cv-03159, 2:18-cv-10775, 2:19-cv-05802, 2:21-cv-02111, 2:22-cv-01993; N.C. M.D. 1:18-cv-00540) and Celgene Corp. v. Dr. Reddy's Labs., No. 19-cv-15343 (D.N.J.) (final judgment regarding the '262 and '427 entered 2022-02-23).
• Claim construction: The D.N.J. court construed "treating multiple myeloma" not to import an efficacy limitation, rejecting Celgene's narrowing construction — a ruling the generics characterized as eliminating the basis on which Celgene had argued patentability (Joint Claim Construction Statement, ECF 211; Markman/related filings, ECF 457). This is public at https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/.
• Federal Circuit: Celgene Corp. v. Mylan Pharmaceuticals Inc., No. 21-1154 (Fed. Cir.) — venue/§ 271(e)(2) appeal involving, among others, the '262 patent; affirmed the district court's dismissal for improper venue as to the New Jersey corporate defendants (opinion at D.N.J. ECF 168, 2021-11-05; docket terminated 2021-11-05 per the drug-patent-watch index — https://www.drugpatentwatch.com/p/litigation/casename/index.php?query=Celgene+Corporation+v.+Mylan+Pharmaceuticals+Inc.%7C21-1154).
• Term: A § 156 patent term extension of 241 days was granted based on the POMALYST NDA 204026 review period (USPTO Notice of Final Determination, In re PTE for U.S. 8,198,262; original expiration 2024-10-19). The Orange Book reflects expiration 2025-06-17 with pediatric exclusivity to 2025-12-17; the Google Patents legal-status line shows "Expired – Lifetime, expires 2025-04-23." Treat these as an unresolved date discrepancy (2025-04-23 vs. 2025-06-17) rather than a settled fact, but all sources agree the patent expired in 2025.

Why this matters more than an IPR: Because no AIA trial was ever filed on the '262, there is no FWD to quote, no canceled claims, and no claim-level PTAB verdict. Any statement that claims 1–27 (or any subset) were invalidated by the PTAB would be unsupported.

Strategic summary

Claim status. All 27 claims of the '262 are as-issued and PTAB-untested. The independent claims are claim 1 (pomalidomide ~1–5 mg/day on a 21-days-on/7-days-off 28-day cycle plus 40 mg dexamethasone) and claim 20 (a parallel dexamethasone-timing variant), with dependent claims 2–19 and 21–27 directed to relapse/refractory status, prior therapy, specific daily doses (1/2/3/4 mg), dexamethasone scheduling, and capsule/tablet forms. None are canceled; none are confirmed by the PTAB. The only claim-scope narrowing on the public record is judicial (the "treating multiple myeloma" construction), not administrative.

Estoppel landscape. Because no petitioner ever filed an IPR/PGR/CBM, § 315(e)(2) estoppel is inapplicable — no party is estopped from raising any prior-art ground in district court or the ITC. The converse also holds: there is no petitioner-side benefit from a prior PTAB record. For a defendant being asserted today, the full universe of § 102/§ 103 art is available — including the D'Amato/Children's Hospital "3-aminothalidomide" art, Davies (2001), the '517 patent, and the prior-art combinations that generic ANDA filers developed in their invalidity contentions (see, e.g., the invalidity-contentions reference to the '262/'939/'428/'427 at ECF 922, Ex. D in Celgene v. Hetero). Note that § 315(b) would time-bar an IPR for any party served with a complaint more than one year ago — the 2017–2019 ANDA defendants are well past that window, and the patent's 2025 expiration removes the equitable upside of an IPR (no injunction to dissolve; only past damages at stake).

Pattern signals. (1) No repeat-petitioner pattern exists — no petitioner ever filed on this patent. (2) No defensive aggregator (Unified Patents) challenge surfaced in any source I reviewed; the Google Patents "family has litigation" links are all district-court/CAFC, not PTAB. (3) The only Celgene PTAB activity in the record concerns different patents: Coalition for Affordable Drugs VI LLC's IPRs against the REMS patents U.S. 6,045,501 and 6,315,720, instituted 2015-10-27, invalidated on 2016-10-26 (Celgene 10-Q disclosure). Celgene did appeal PTAB outcomes in the REMS matter, so the patent owner is not appeal-shy — but that says nothing about the '262. (4) The current offensive activity around the '262 is antitrust/§ 1 sham-litigation, not PTAB: the Cigna/CenterWell and related complaints allege the '262, '939, and '428 were fraudulently procured (undisclosed '517/D'Amato materiality), which is a district-court inequitable-conduct theory the PTAB cannot reach.

Recommended next steps

1. State it plainly: there is no PTAB proceeding on US 8,198,262. Do not represent to a court, client, or adversary that any claim has been canceled or confirmed by the Board. The absence is genuine, not a data gap — though confirm via a direct patent-number query in PTAB E2E (https://ptab.uspto.gov) and the PTAB Decisions search before filing anything that relies on it.

2. Reframe the defense around the forum that actually decided things. The usable public record is (a) the D.N.J. Markman rejecting the efficacy-importing construction (https://storage.courtlistener.com/recap/gov.uscourts.njd.348812/) and (b) the pending inequitable-conduct/fraud-on-the-PTO allegations in the pomalidomide antitrust actions (Cigna/CenterWell, S.D.N.Y. 1:24-cv-06924; Hagens Berman filings). Those are your leverage points — not an IPR.

3. Check the § 315(b) clock and the expiration math before even considering a petition. If your client (or a privy) was served with a complaint asserting the '262 more than one year ago, an IPR is barred. With the patent expired (2025-06-17 / 2025-12-17 per Orange Book; 2025-04-23 per Google Patents), a new IPR has little practical value beyond a past-damages validity finding — and the patent owner can no longer amend. Note the date discrepancy explicitly rather than asserting a single expiration date.

4. If you need a claim-level validity opinion, build it from the district-court invalidity contentions and the '517/D'Amato materiality record, and coordinate with any existing inequitable-conduct litigation — because with no FWD and no estoppel, that is the only claim-level work product that exists.

Verification gaps (stated honestly): (i) I could not run an exhaustive PTAB E2E docket query by patent number because my search step budget was exhausted; (ii) I could not confirm the exact 2025 expiration date (2025-04-23 vs. 2025-06-17 vs. pediatric 2025-12-17); (iii) no AIA-trial proceeding number exists in any source I reviewed, so I have not supplied one.

I'll research the assignment chain for US 8,198,262 across USPTO assignment records and related sources.

Found the key assignment record. Let me verify the correspondent, the corporate succession (Celgene → Bristol-Myers Squibb), and check for any post-2013 recordings.

Let me pin down the correspondent firm at 222 East 41st Street and check for any Celgene→BMS merger recording.

I hit the tool-step limit, so the below rests on the assignment record I did retrieve. Sourcing note: I could not open assignmentcenter.uspto.gov directly. The operative record below is a USPTO Assignment Search printout (web interface v.2.3.2) reproduced as an exhibit to an FDA citizen petition (regulations.gov, FDA-2014-E-1239-0002, attachment 1), which prints "Total Assignments: 1" for patent 8,198,262 together with the full reel/frame, assignor, assignee and correspondent fields, plus the PTO Notice of Recordation of Assignment Document itself. This is corroborated by Google Patents' legal-events entry (single "Assigned to CELGENE CORPORATION" event, 2008-08-19). The printout is dated roughly 2013–2014, so a later recording would not necessarily appear in it — but Google Patents' legal events, fetched 2026-10-01, likewise show no second assignment. Verify at https://assignmentcenter.uspto.gov/ (search 8198262).

Inventors

Jerome B. Zeldis — sole named inventor. Residence given in the assignment instrument as 157 Christopher Drive, Princeton, NJ (zip printed as "03540" in the OCR; almost certainly 08540).

• Employer at time of filing: Celgene Corporation. Zeldis was a Celgene officer (widely reported as Celgene's Chief Medical Officer, later President of Celgene Global Health) from 2001 onward. He is the assignor on the only recorded assignment, and he assigned to Celgene — i.e., inventor-to-employer, not a third party.
• Timing note: the instrument he executed was directed to parent application 10/438,213, filed May 15, 2003; the '262 itself was filed 2008-08-19. Zeldis was a Celgene insider at both dates. No "inventors departing within 12 months of filing" pattern is present.
• Unusual pattern that is present (neutral, not an NPE tell): the sole inventor of a $bn-product method-of-use patent is the assignee's own Chief Medical Officer. This is the signature of the three "Zeldis patents" (the '262 together with US 8,735,428 and US 8,673,939 — cross-referenced in the prior section), which were later attacked on inventorship/"unexpected results" grounds in the Pomalyst antitrust pleadings. I note the fact; I make no finding on those allegations.

Original assignee

Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 (per the recorded assignment page). The underlying instrument itself recites Celgene at 7 Powder Horn Drive, Warren, NJ 07059 — Celgene's legacy HQ and the address the '262 specification uses ("available from Celgene Corporation, Warren, N.J."). The two addresses are both genuine Celgene addresses; not a red flag.

• Product embodying the claims: yes. The '262 claims a method of using pomalidomide (ACTIMID™ → POMALYST®), and the patent received a 241-day §156 term extension expressly based on NDA 204026 for POMALYST (pomalidomide). The PTE notice names the applicant as Jerome Zeldis and "Owner of Record: Celgene Corporation."
• Primary line of business: branded biopharmaceuticals (hematology/oncology, inflammation). Operating company, not a licensing vehicle.
• Current status: acquired, but operating — not dissolved, not in bankruptcy. Bristol-Myers Squibb Company closed its $74bn acquisition of Celgene on 2019-11-20; Celgene became a wholly owned BMS subsidiary and CELG ceased trading. The Orange Book applicant field now reads "Bristol." No merger/change-of-name assignment was recorded against the '262, so the recorded chain of title still terminates at Celgene Corporation (see flags below).

Assignment timeline

Total recorded assignments against US 8,198,262: 1. (USPTO Assignment Search: "Total Assignments: 1".)

• 2003-09-03 (executed) / recorded 2008-08-19 — Reel 021461/0407, 3 pages
  • Conveyance: Assignment of assignor's interest ("ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)"). PTO Notices of Recordation dated 2008-08-19 and 2008-09-02.
  • Assignor: ZELDIS, JEROME B. (157 Christopher Drive, Princeton, NJ)
  • Assignee: CELGENE CORPORATION, 86 Morris Avenue, Summit, NJ 07901
  • Correspondent: address of record 222 East 41st Street, New York, NY 10017-6702. The name line of the correspondent field was not captured in the retrieved text — I am therefore not asserting the correspondent firm's name as a fact. Two evidentiary anchors point the same way: (i) the assignment instrument itself names "Pennie & Edmonds LLP" as attorney (docket 009516-0074-999); (ii) Celgene's later prosecution/PTE filings on this very patent were signed by Anthony M. Insogna, Esq., Jones Day, 250 Vesey Street, New York (PTE final determination). Pennie & Edmonds dissolved in 2004 and much of its IP practice moved to Jones Day — so the 2008 recording was plausibly filed by the successor firm. Flag: this is an inference from the address and the Unchanged-solicitor pattern, not a name read off the reel. With n=1 assignment in the chain, no repeat-correspondent recurrence can be established (see signal 3).
  • Context: internal — inventor-to-employer assignment under obligation; not a sale. Recorded in 2008 against the continuation-in-family app 12/229,074 even though the instrument was executed in 2003 to assign the parent 10/438,213 (filed 2003-05-15).

Flags on this timeline

1. Distinct execution vs. recording dates (2003-09-03 vs. 2008-08-19). The instrument was signed while the file was at Pennie & Edmonds but sat unrecorded for ~5 years, until the 2008 continuation was filed and docketed. This explains — and now resolves — uncertainty #4 carried over from the prior section, which noted the 2003-09-03 date appearing in the FDA record. It is an administrative lag, not a transfer to a new owner.
2. Instrument/target mismatch. The assignment page bears application number 12229074 (the '262) but the document text describes the invention as "METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES" and Application No. 10/438,213. Because the '262 is a descendant of that parent under a common specification (as noted in the prior section's claim-construction discussion), one assignment to Celgene covers the family. Worth naming because a bank or purchaser running a strict record chain will spot the face-value mismatch.
3. Missing merger record. The single largest ownership event in this patent's life — the 2019-11-20 Celgene/Bristol-Myers Squibb merger — produced no assignment, merger, or change-of-name record on the '262 in the sources I retrieved, despite the Orange Book applicant having changed to Bristol. Absence of a recorded merger instrument does not by itself change title (successorship by operation of law), but on the recorded record Celgene Corporation remains the assignee.

Timeline diagram

timeline
    title Ownership of US 8198262
    2003 : Zeldis executes assignment to Celgene
    2008 : Recorded at USPTO reel 021461 frame 0407
    2012 : Patent issues on June 12
    2017 : Celgene asserts patent against ANDA filers
    2019 : Celgene acquired by Bristol-Myers Squibb
    2025 : Patent term ends after 241 day extension

NPE / troll-pattern signals

Verdict

Operating-company assertion.

Justification: the entire recorded chain consists of one instrument, reel 021461/0407, executed 2003-09-03 and recorded 2008-08-19, conveying sole inventor Jerome B. Zeldis's rights to Celgene Corporation — a branded manufacturer that shipped POMALYST® (pomalidomide) embodying the claims, obtained a 241-day §156 extension on this patent based on NDA 204026, Orange-Book-listed it, and then sued actual ANDA competitors (D.N.J. 2:17-cv-03159, 2:17-cv-03387, and successors) in its own name. Not one of the eight NPE signals is present; the absence of any shell entity, any known asserter, and any pre-suit transfer is decisive. The only ownership anomalies are administrative: a five-year lag between execution and recording, a face-value mismatch between the instrument's named parent (10/438,213) and the recorded application (12/229,074), and the absence of any recorded record of the 2019 Celgene→Bristol-Myers Squibb merger.

Verification links: https://assignmentcenter.uspto.gov/ (search "8198262") and https://assignment.uspto.gov/patent/index.html#/patent/search?q=8198262 — the record to look for is Reel 021461 / Frame 0407, correspondent address 222 East 41st Street, New York, NY 10017-6702.

Standing caveats: (a) I could not query Assignment Center live; the "Total Assignments: 1" figure comes from a USPTO printout of roughly 2013–2014 reproduced in an FDA citizen-petition exhibit, corroborated by Google Patents legal events fetched 2026-10-01. (b) The correspondent firm name was not present in the retrieved text — only the street address — so the Pennie & Edmonds / Jones Day attribution is flagged as inference. (c) I did not locate a recorded Celgene→BMS merger instrument; I cannot exclude that one was recorded under a different application or reel that my searches did not surface.

I'll research the prior-art citations for US 8,198,262. Let me run several searches in parallel.

Let me try to retrieve the actual "References Cited" front page and the Justia/Google citations lists.

Prior-Art Analysis for US 8,198,262 B2

0. Scope, method, and a necessary caveat

What I was able to do: I ran searches against Google Patents (which mirrors USPTO bibliographic and citation data), Justia Patents, the EPO/publication-server family lists, the FDA/Orange Book Pomalyst listing, and litigation filings on CourtListener and the Hagens Berman Pomalyst complaint docket.

What I could not do: I could not query USPTO Patent Center / PAIR directly, and the Google Patents text supplied for this matter is sanitized — it contains the "Prior art keywords" block (administered, compound, patients, multiple myeloma, cancer) but not the literal "(56) References Cited" front-page list. I therefore cannot hand you a verbatim transcription of the '262 face citations. I hit my tool-call ceiling before I could pull the patentimages PDF front page or the Justia "References Cited" tab for 8,198,262 specifically.

So the list below is a reconstruction, built from three independently sourced buckets, each labeled with its provenance. Where I am inferring rather than quoting, I say so. I will not assert a front-page citation I could not substantiate.

Sourcing key:

• [SPEC] — reference appears in the '262 specification text itself (authoritative; the text you supplied names these patents).
• [FAMILY] — reference appears in the "patent documents cited in the description" list of European family members (EP 3,182,996 B1 / EP 3,925,609) that share the Celgene IMiD specification. URL: https://patentimages.storage.googleapis.com/48/d2/cb/5aaab2ac0a724d/EP3182996B1.pdf and https://data.epo.org/publication-server/rest/v1.2/publication-dates/2025-07-30/patents/EP3925609NWB1/document.pdf — this is a proxy for the '262 front page, not a substitute for it.
• [PROS] — reference relied on by the examiner/applicant during prosecution of the '262 or its terminal-disclaimer siblings, as recited in the applicant's own prosecution response: https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/gov.uscourts.njd.348812.250.4.pdf and in the Pomalyst complaints: https://www.hbsslaw.com/sites/default/files/case-downloads/pomalyst-pomalidomide/2023-09-07-complaint.pdf
• [LIT] — reference pleaded as invalidating art in the Pomalyst antitrust/inequitable-conduct actions: https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf and https://storage.courtlistener.com/recap/gov.uscourts.nysd.[628251](/patent/628251)/gov.uscourts.nysd.628251.1.0.pdf

Date caveat up front: issue/publication dates below are from my knowledge of the public record and should be verified against the patent face or Patent Center before being quoted in a filing. I have flagged the ones I am least sure of.

1. Two thresholds flagged before the analysis

(a) A contradiction with the earlier section. The prior summary states the '262 has two independent claims (1 and 20) and 27 total claims. The FDA-attachment copy of the patent in the regulations.gov record (https://downloads.regulations.gov/FDA-2014-E-1239-0002/attachment_1.pdf, page 39) shows the same claims 1–27 and then continues "28. The method of…". That copy is labeled "US 8,198,262 B2." The '262 therefore appears to have more than 27 claims. I flag this rather than assert a claim count I did not verify against the printed patent. This matters for prior-art mapping: any claim beyond 27 is unaccounted for in the earlier section.

(b) The §102 vs. §103 distinction is doing real work here. Your instruction asks which claims each reference "potentially anticipates under 35 U.S.C. § 102." I have to give you the honest answer: on the claims as I understand them, essentially none of the cited references alone anticipates any claim, and the applicant successfully argued exactly that. Every independent claim (1 and 20) carries three conjunctive limitations — (i) pomalidomide 1–5 mg/day, (ii) 21 consecutive days on / 7 consecutive days off in a 28-day cycle, and (iii) 40 mg dexamethasone. Pre-AIA §102 anticipation requires all elements in a single reference, arranged as claimed. I could not find a single cited reference that supplies all three. The bulk of the art below was deployed under §103 in prosecution and is pleaded under §103 in litigation. I say so per reference rather than dressing §103 art up as §102 art.

(c) Effective filing date. Application 12/229,074 was filed 2008-08-19 but is a continuation; the family chain per the Cigna complaint is 60/380,842 (2002-05-17) → 60/424,600 (2002-11-06) → 10/438,213 (2003-05-15) → 12/229,074 (2008-08-19). This is a pre-AIA patent, so §102(a)/(b)/(e)/(g) control. Critically, the art that actually threatens the claims is art published before the 2002–2003 priority window — i.e., the Kyle/Davies/Corral/Muller/Lentzsch/Schey cluster, not the 2008 filing date.

2. Group A — Patent documents cited in the specification / family [SPEC][FAMILY]

3. Group B — Examiner-cited prosecution art [PROS]

The applicant's own response (CourtListener njd.348812.250.4.pdf) recites a rejection of claims 24–28, 36 and 53 under pre-AIA §103(a) "over Kyle, in view of Davies, Corral, Muller and U.S. Pat. No. 6,555,554," and a parallel rejection over the same combination. The applicant argued the combination taught at most that "thalidomide may be used for treating multiple myeloma or that certain unidentified immunomodulatory compounds can be explored further," and submitted MacNeil (2010) to show that "small differences in structure of pomalidomide from thalidomide mean very important differences in terms of side effect profiles, efficacy, and potency."

Prosecution takeaway: the examiner never asserted §102 anticipation; the fight was entirely §103, and the claims survived because Kyle/Davies/Corral/Muller lacked the 1–4 mg/day + dexamethasone + specific dosing regimen combination.

4. Group C — Non-patent literature [SPEC][LIT]

The '262 specification also cites, as background, Burger's Medicinal Chemistry and Drug Discovery (172–178, 949–982, 5th ed. 1995); Design of Prodrugs (Bundgaard ed., 1985); Stockdale, Medicine vol. 3, ch. 12, §10 (1998); Physicians' Desk Reference 1755–1760 (56th ed. 2002); Remington's Pharmaceutical Sciences (16th/18th eds.); Carstensen, Drug Stability: Principles & Practice (2d ed. 1995, 379–80); Jacques, Enantiomers, Racemates and Resolutions; Penichet & Morrison, J. Immunol. Methods 248:91–101 (2001); and Emens et al., Curr. Opinion Mol. Ther. 3(1):77–84 (2001). None of these bears on the MM dosing limitations.

The substantive NPL asserted in the Pomalyst complaints as MM-specific art is:

5. Group D — Litigation-alleged invalidating art: the D'Amato pomalidomide filings [LIT]

The Cigna and NYSD complaints allege Celgene acquired and then buried D'Amato's earlier pomalidomide filings, which used "3-aminothalidomide" to name pomalidomide:

Important framing: these are pleaded allegations, not adjudications. I have not located a judgment invalidating or holding the '262 unenforceable.

6. §102 anticipation scorecard

Bottom line: on the claim set as I understand it, no cited reference anticipates any claim under §102. The patent's validity turned, and turns, on §103 — and specifically on whether the 21-on/7-off pomalidomide cycle plus 40 mg dexamethasone was obvious over Schey + Kyle + Coleman + Cohen + the Celgene compound patents.

7. The most relevant prior art, ranked

1. Schey (April/June 2002) and Schey (October 2002) — pomalidomide in relapsed/refractory MM at 1–5 mg/day (MTD 5 mg). The single most on-point reference; alleged to have been withheld from prosecution.
2. Lentzsch (2001) and Lentzsch (2002) — pomalidomide anti-MM activity; the second prong of the diligence/inequitable-conduct theory.
3. D'Amato 10/166,539 — the only pre-2003 filing that names both pomalidomide and multiple myeloma.
4. US 5,635,517 (compound disclosure) with US 6,316,471 / US 6,555,554 / US 6,281,230 (generic methods, dose ranges, optional dexamethasone).
5. Kyle (2001) + Coleman (2002) + Cohen (1982) — the examiner's §103 combination: thalidomide in MM + 40 mg dexamethasone + the 21/7 schedule.
6. Davies (2001), Corral (1999), Muller (1999), Hideshima (2000) — secondary §103 support.

8. Explicit uncertainties

1. I could not retrieve the literal (56) front-page citation list for US 8,198,262. Groups A–D are reconstructions from the specification text, the EPO family lists, the prosecution response, and litigation pleadings. Treat the [FAMILY]-tagged items (A12 and the foreign/companion documents) as proxy-sourced and unverified against the '262 face.
2. Claim-count discrepancy — the FDA copy shows claim 28 existing, contradicting the earlier section's "27 claims / independents 1 and 20." Unresolved.
3. I did not verify issue dates for A4, A5, A6, A11, A12 or the cytokines in A10 against the printed patents.
4. Exact citations for Davies (2001), Corral (1999), Muller (1999), Hideshima (2000), Coleman (2002), Cohen (1982) and MacNeil (2010) are given as the litigation/prosecution record characterises them; I have full bibliographic detail only for Kyle (2001). The complaints supply footnote numbers for Schey and Kyle but the snippet I retrieved truncated several of them.
5. Cohen (1982) — I could not confirm the author, venue or full citation beyond the litigation's paraphrase ("the 21 day administration of an anticancer drug, followed by 7 days of rest").
6. D'Amato application publication status (whether 09/899,344, 09/966,895, 10/166,539 and 10/020,391 published, and when) is the open question that determines whether they are §102(e) art at all. I did not resolve it.
7. Nothing here reflects an adjudicated holding; the inequitable-conduct and invalidity theories are pleaded, not proven.

If you can give me access to the Patent Center file wrapper or the front-page PDF, I can complete the literal (56) enumeration and convert this reconstruction into a verbatim citation table with per-claim §102/§103 mapping.

I'll research the prior art references cited on this patent's record and the state of the art as of the priority date, then build the § 103 analysis.

Now let me research the specific prior-art references used in prosecution and the declarations relied upon.

Let me pull details on the Kyle and Coleman references plus the Celgene compound patents.

Obviousness Analysis — U.S. Patent No. 8,198,262 (35 U.S.C. § 103)

Scope note: This is a technical-analyst assessment, not a legal opinion. It builds directly on the two prior sections (patent summary and litigation summary) and does not repeat their bibliographic content. Two flags carried forward: (i) the claim-text discrepancy noted below; and (ii) the inequitable-conduct/prior-art-suppression narrative appearing in the Pomalyst complaints is pleaded, not adjudicated — I use those filings only as a finding aid for locating the underlying references, and I cite the references themselves.

1. The claims under analysis

Per the prior section (which I take as authoritative for claim language), the '262 has two independent method claims:

• Claim 1: treating MM with (a) pomalidomide, 1–5 mg/day, 21 consecutive days on / 7 days off in a 28‑day cycle; and (b) 40 mg dexamethasone.
• Claim 20: same 21‑on/7‑off 28‑day cycle; 40 mg dexamethasone on at least one of days 1–21. No numeric pomalidomide dose is recited.

The dependent claims add only: disease sub-type (relapsed, refractory, newly diagnosed), prior-therapy history, pomalidomide dose selected from {1, 2, 3, 4} mg/day, dexamethasone scheduling, and capsule/tablet with mannitol + pre-gelatinized starch.

⚠️ Flagged contradiction. The prior summary states claim 1 recites "about 1 mg to about 5 mg per day." The prosecution record retrieved in this analysis repeatedly describes the claims as "1 to 4 mg/day" (Applicant's Remarks, D.N.J. 2:17‑cv‑03387, D.E. 250‑4; CenterWell/Cigna complaints). These are likely different claim versions (pre- vs. post-amendment) or a mix-up between the '262 and its '428/'939 continuations. I analyze the 1–5 mg/day range as authoritative per the issued-claim summary, and note that the analysis is essentially unchanged either way because both ranges sit inside the prior-art ranges.

2. Scope and content of the prior art

The Google Patents "prior art keywords" for this page are administered / compound / patients / multiple myeloma / cancer — i.e., the art is squarely a drug-dosing art, and the field was mature and crowded by the 2002 priority window. The references the record actually engages are:

The single most important observation: by mid‑2002, the art already disclosed (a) the compound pomalidomide, (b) its use for MM specifically, (c) its use in patients who had failed prior therapy, (d) oral dosing at 1–5 mg/day, (e) combination with 40 mg dexamethasone, and (f) 21‑on/7‑off 28‑day cycling of an anticancer drug with dexamethasone.

3. The differences between the prior art and the claims

Reduced to elements, claim 1 requires: [A] pomalidomide → [B] treat MM → [C] 1–5 mg/day → [D] 21 on/7 off, 28‑day cycle → [E] + 40 mg dexamethasone.

So there is no missing element. The only arguable "gap" is the specific permutation of known elements — which is precisely the situation KSR addresses.

4. Motivation to combine

Under KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), and its Federal Circuit progeny, the motivation need not be explicit in any one reference; it may come from "the nature of the problem to be solved," from market forces, from the "finite number of identified, predictable solutions," or from design incentives in the field. See also In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998) ("the problem itself may provide a reason"). Here, the motivation is unusually strong because these references cross-reference each other:

1. Same inventors/assignee, same research program. '517, '230, '471 and '554 are Celgene/Muller patents disclosing the same genus; the specification of the '262 itself cites '517, '230, '471, '929,117, '874,448. A POSA screening that genus for oncology indications would necessarily arrive at pomalidomide. KSR ("a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions").

2. Express "lead compound" signal. D'Amato 2001 and Davies 2001 rank pomalidomide as the most potent analog (15,000× / 50,000×). Once a POSA is told thalidomide works in MM (Kyle; Rajkumar) and that a more potent analog exists (D'Amato; Davies; Lentzsch), "select the more potent congener" is not invention — it is the routine substitution of a known, better-performing member of a small, identified class with demonstrated activity against the same target.

3. Explicit "combine with dexamethasone" teaching. '471 itself teaches administering pomalidomide in combination with steroids "such as dexamethasone" for cancer. Kyle, Rajkumar/Kyle and Coleman teach the 40 mg Thal/Dex regimen. Layering a known combination partner onto a known anti-MM agent is a textbook obviousness combination. In re Kao is the leading cautionary case, but there the art lacked the specific combination/endpoint teaching that exists here.

4. Rational basis to optimize the dose. The examiner's stated motivation — that Kyle teaches adjusting the regimen for efficacy/tolerability (stop for rash, resume lower) — is the classic In re Aller / In re Boesch "result-effective variable" rationale: dose is a recognized, result-effective variable that a POSA will optimize as a matter of routine. Schey had already done the optimization, reporting an MTD of 5 mg/day.

5. Rational basis to cycle 21/7. Cohen 1982 teaches precisely the 21‑day-on/7‑day-off 28‑day cycle with dexamethasone in cancer. The NCI's explanation of cycle rationale ("a period of treatment followed by a period of rest") is common general knowledge. And Celgene's own '569 claim 1 — which the examiner expressly directed the '262 applicant to incorporate — embodies lenalidomide 21/7 + dexamethasone, i.e., the very cycle in the very drug class.

6. A POSA had a reasonable expectation of success. D'Amato, Lentzsch and Schey report actual anti-MM activity (and Lentzsch reports complete remissions) for pomalidomide; Hideshima reports that the class overcomes resistance. Efficacy of the combination with dexamethasone was already established for thalidomide (Kyle; Rajkumar/Kyle; Dimopoulos 2001). That is a strong, not speculative, expectation of success.

5. Specific § 103 combinations that would render the claims obvious

Combination A (2 references — the strongest).
'471 (pomalidomide, cancers, oral, 1–100 mg unit dose, combination with dexamethasone) + Schey 2002 (pomalidomide/CC‑4047 oral 1, 2, 5, 10 mg/day for 4 weeks in relapsed/refractory MM; MTD 5 mg/day).
→ Yields [A], [B], [C] (1–5 mg/d = the 1, 2 and 5 mg cohorts), [D] (4‑week daily dosing, i.e., a 28‑day cycle; the "7 days of rest" adds only Cohen's routine rest period), [E] via '471's dexamethasone teaching. Claim 1, 2, 5, 10–13, 14–18 read on this combination.

Combination B (the "lead-compound" combination).
'517 or '471 (genus incl. pomalidomide, TNF‑α → cancer) + D'Amato 2001 (pomalidomide directly inhibits myeloma proliferation) + Coleman 2002 (40 mg dexamethasone with thalidomide) + Cohen 1982 (21/7 28‑day cycle with dexamethasone).
→ Yields every element, with the motivation supplied by D'Amato/Davies ranking pomalidomide as the superior congener.

Combination C (resistance-argument combination).
Hideshima 2000 (thalidomide analogs overcome MM drug resistance) + Davies 2001 (IMiDs for relapsed/refractory MM) + Kyle 2001 (40 mg dexamethasone regimen) + Cohen 1982 (21/7 cycle).
→ Directly targets dependent claims 2, 4, 6–9 (relapsed/refractory, prior therapy).

Combination D (the PTO's actual rejection, in the alternative).
Kyle + Davies + Corral + Muller + '554 — the examiner's five-reference formulation, and the '517 + Davies + '230 formulation applied to other claims. These were withdrawn after Celgene's arguments and the Thakurta declaration; I flag below why the withdrawal should not be read as an adjudicated finding of non-obviousness.

For dependent claims 16–19 and 26–27 (capsule = pomalidomide + mannitol + pre-gelatinized starch): the '262/'471 specifications themselves list mannitol, pre-gelatinized starch and microcrystalline cellulose among suitable excipients, and in the related '467 prosecution the examiner reasoned that "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." Combining the '471 dosage-form teaching with routine pharmacy optimization (KSR: "combination of familiar elements according to known methods") makes these claims obvious as well.

6. Rebuttal side — what would have to be shown, and the criticality problem

Criticality is the central battleground. Where the prior art discloses a broad numerical range and the claim recites a narrower sub-range, the burden shifts to the applicant to show that the sub-range is critical (i.e., unexpectedly superior). In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003); In re Boesch, 617 F.2d 272 (CCPA 1980). Here:

• 1–5 mg/day sits entirely inside '471's 1–100 mg range and coincides with Schey's tested 1, 2 and 5 mg cohorts — and 5 mg is Schey's reported MTD. That is the paradigm of an overlapping/optimized range without demonstrated criticality.
• 40 mg dexamethasone coincides exactly with the Kyle/Rajkumar/Coleman Thal/Dex dosing.
• 21/7 in a 28‑day cycle coincides with Cohen 1982 and with the NCI's generic cycle rationale.

The applicant's rebuttal evidence was (a) arguments and (b) a Rule 132 declaration. The December 2011 Remarks argued "impermissible hindsight" and that "[t]he mere need to use five references... is an indication of its lack of obviousness," and the October 2013 Thakurta Declaration asserted "unexpected results" — specifically that non-reciprocal cross-resistance between pomalidomide and lenalidomide was "surprising." Two doctrinal points:

1. "Number of references" is not a valid non-obviousness argument. KSR expressly rejects the rigid "teaching, suggestion, or motivation" test, and the Federal Circuit has long held that the number of references is irrelevant; what matters is the reason to combine. A 2012 allowance procured on that argument is legally fragile.
2. "Unexpected results" must be commensurate with the scope of the claims and must be non-obvious at the time of filing. If, as the complaints allege, cross-resistance/relative potency data for pomalidomide was already public (Stirling declaration in the '517 reexamination; D'Amato's potency statements; Hideshima), a later-filed declaration asserting the opposite would not be probative. However — and I stress this — the "false declaration / fraud on the PTO" characterizations are pleaded allegations in antitrust and class complaints; no judgment of invalidity or unenforceability of the '262 has been located.

Genuine counter-arguments that survive:

• In re Kao, 639 F.3d 1057 (Fed. Cir. 2011) — a dosing-regimen patent survived where the art taught away from the claimed range and the applicant showed unexpected results commensurate with the claims. If the '262's 1–5 mg range reflected a genuine, demonstrated dose-response inflection (efficacy retained with materially reduced toxicity), that is a colorable rebuttal.
• MacNeil (2010) — cited by the applicant for the proposition that "small differences in structure of pomalidomide from thalidomide mean very important differences in terms of side effect profiles, efficacy, and potency." But MacNeil is 2010, i.e., after-the-fact evidence; it cannot establish that the difference was unexpected as of 2002.
• Teaching away — not established. Nothing in '471/Schey/Kyle dissuades use of pomalidomide 1–5 mg/day with 40 mg dexamethasone on a 21/7 cycle.

7. Priority-date vulnerability (a compounding risk)

The claims as allowed were amended (per the examiner's March 1, 2012 interview summary) to incorporate "the limitations of claim 1 of U.S. Pat 7,968,569 — particularly the cyclical administration... for 21 consecutive days followed by 7 consecutive days of rest... in a 28 day cycle in combination with 40 mg of dexamethasone." That limitation derives from application 10/438,213, filed May 15, 2003. If the 21/7 + 40 mg dexamethasone limitation is not supported by the '262's earliest priority document (Google Patents lists 2002‑05‑17; the complaints trace the family to provisional 60/424,600 filed 2002‑11‑06), then the effective filing date slides forward and the 2002 references — Schey (Apr./June/Oct. 2002), Lentzsch (2002), D'Amato (Dec. 2001), Coleman (2002), Hunt (2002) — become clean § 102(b) art rather than § 102(a)/(e)-contested art. This is an argument a challenger would press; I have not verified the written-description support in the priority documents, and I flag it as unresolved.

8. Confidence, and what I could not verify

• High confidence that each individual element of claims 1 and 20 is disclosed in the prior art, and that multiple independent rational motivations to combine exist (KSR-type and In re Rouhett/In re Aller type). This is the strongest part of the analysis.
• High confidence that claim 20 (no dose range; dexamethasone on "at least one of days 1–21") is the more vulnerable independent claim, because it omits even the numerical scaffold that Celgene relied on for criticality.
• Cannot verify: the § 102 qualification dates of Schey (Apr./June/Oct. 2002), Lentzsch (2002), Coleman (2002) and Hunt (2002) against the operative priority date; and whether the issued claim 1 says 1–5 or 1–4 mg/day. Both should be resolved against the file wrapper (USPTO Patent Center, App. 12/229,074) and the priority documents before any firm conclusion.
• Explicitly flagged as non-authoritative: all "inequitable conduct," "fraud," "false declaration" and "material omission" characterizations above are drawn from complaints (Cigna v. Celgene; CenterWell v. Celgene; the Pomalyst class complaints). They are allegations. I found no adjudicated holding of invalidity or unenforceability of the '262, and the patent is now expired (2025), which moots most infringement-facing relief but not collateral validity/antitrust questions.
• I did not retrieve the '262's own file wrapper directly; the prosecution quotations above come from party filings reproducing Office Actions and Remarks (D.N.J. 2:17‑cv‑03387, D.E. 250‑3/250‑4) and should be confirmed against the official record.

Bottom line: Under KSR and the Federal Circuit's range-optimization and dosage-regimen lines of authority, claims 1 and 20 — and all dependent claims — appear prima facie obvious over combinations of the Celgene compound patents ('517/'471/'230/'554), the pomalidomide/MM efficacy literature (D'Amato 2001, Lentzsch 2001/2002, Schey 2002, Davies 2001, Hideshima 2000), and the thalidomide/dexamethasone dosing literature (Kyle 2001, Rajkumar & Kyle 2001, Coleman 2002, Cohen 1982). The only durable rebuttal path is a properly commensurated showing that the 1–5 mg/day × 21/7 × 40 mg dexamethasone regimen produced unexpected results as of the 2002 priority date — and the allowance record suggests the contrary assertion rested largely on a post-hoc Rule 132 declaration and on the legally disfavored "too many references" argument.