US 9101622

I'll research US patent 9101622 across the sources you specified.

Let me dig for the claim text and any 2026 Federal Circuit activity.

US Patent 9,101,622 — Analyst Summary

Source hierarchy note: The authoritative full text you supplied (Google Patents render of US9101622B2, fetched 2026‑10‑01) takes precedence over everything below. Where I relied on secondary sources, I say so. Where I could not verify something, I say so explicitly rather than filling the gap.

Also, a literal‑identifier caution: the string "9101622" also appears as Brazilian utility model MU 9101622‑3 U2 (Industria e Comercio de Climatizadores União Ltda., filed 13/07/2011, published in INPI Revista PATENTES 2141) — an air‑conditioning filing, entirely unrelated. I excluded it. "0901622"‑style variants and the sibling US 9,101,621 are likewise not this patent.

1. Bibliographic data

Priority chain (well‑grounded): US 8,198,262 (from the same Zeldis family) recites: division of application 10/438,213 filed 2003‑05‑15 (now US 7,968,569), which claims provisional 60/380,842 filed 2002‑05‑17 and provisional 60/424,600 filed 2002‑11‑06. The 2002‑05‑17 priority date shown on US 9,101,622 for the title

• Notable: because the filing date is 2014 but priority traces to 2002, the 20‑year term runs from the 2003 non‑provisional, yielding the May 15, 2023 expiry (consistent with the statutorily‑disclaimed/terminal‑disclaimer family pattern noted below).

2. Abstract

I could not extract the verbatim abstract string for 9,101,622 from the retrieved render — the page I have is dominated by bibliographic and term‑frequency data. However, the term‑frequency table in the authoritative text lists, under the abstract heading, exactly: angiogenesis, adverse, radiotherapy, chemotherapy, diseases and disorders, biotherapy, immunotherapy, hormone therapy, immunomodulatory effect, neoplasm, dosage form, active ingredient, cancer, pharmaceutical composition, effects. That fingerprint matches the standard Celgene/Zeldis family abstract appearing verbatim on the companion cases, e.g. US 8,198,262, US 9,283,215, and US 10,206,914:

"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."

Confidence: high but not verified for this specific document. Treat the exact wording as probable, not confirmed. (Source for the boilerplate: https://storage.courtlistener.com/recap/gov.uscourts.njd.[411954](/patent/411954)/gov.uscourts.njd.411954.1.0.pdf ; https://patentimages.storage.googleapis.com/6d/13/25/bdb0c5ef58b3eb/US9283215.pdf)

3. Independent claims — plain language (with an explicit caveat)

Caveat first: I was unable to retrieve the literal, numbered claim set of US 9,101,622 from the sources returned in this session. The following is reconstructed from three independent lines of evidence on the page you supplied plus a corroborating third‑party record. It is a reconstruction, not a transcription. Do not rely on it for claim‑charting, validity analysis, or infringement opinions without pulling the granted claims from USPTO PatentCenter/Public PAIR or the printed patent.

Principal independent claim (claim 1) — reconstructed

Plain language: A method of treating multiple myeloma in a human patient who has not previously received treatment for multiple myeloma ("newly diagnosed"), comprising administering to that patient:

• a therapeutically effective amount of 3‑(4‑amino‑1‑oxo‑1,3‑dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione (the compound now known as lenalidomide; structure GOTYRUGSSMKFNF‑UHFFFAOYSA‑N per the page), or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate or prodrug thereof; and
• a therapeutically effective amount of dexamethasone (structure UREBDLICKHMUKA‑CXSFZGCWSA‑N per the page).

The two agents are administered as a combination regimen, with the patient population limited to the first‑line/newly‑diagnosed setting rather than relapsed or refractory disease.

Evidence for this reading:

1. The granted title itself confines the method to "newly diagnosed multiple myeloma … in combination with dexamethasone."
2. An independent third‑party record (Taiwan IPO filing‑history annex on the Revlimid patent family) renders the coverage of 9,101,622 as: "Method of treating multiple myeloma in combination with dexamethasone for patient who has not received previous treatment for multiple myeloma" — i.e., the same first‑line/dexamethasone limitation. (Source: https://www1.tipo.gov.tw/tw/dl-[287732](/patent/287732)-d05ed916c6074a6b947bd0154233b51e.html)
3. The page's own concept table lists dexamethasone under "title claims description" and lenalidomide under "title description" — confirming dexamethasone is a claim element while lenalidomide is the named compound.

Possible additional independent claims

I cannot confirm or exclude additional independents (e.g., a composition/single‑unit‑dosage‑form or kit claim, which the family abstract advertises). The page's claim‑level concept list does show formulation terminology present in the claims — capsule, microcrystalline cellulose, magnesium stearate, croscarmellose sodium, lactose — which is consistent with at least one dependent claim (or a separate independent claim) directed to an oral capsule dosage form of the lenalidomide component with those excipients.

Dependent‑claim subject matter indicated by the claim‑level term data

Terms the page maps to the claims section include: melphalan, cyclophosphamide, doxorubicin, vincristine, prednisone, stem cell transplantation, proteasome inhibitor, dose‑limiting toxicity, maximum tolerated dose. This suggests dependent claims reciting, variously: a third active agent (e.g., an alkylator such as melphalan or cyclophosphamide, an anthracycline such as doxorubicin, a vinca such as vincristine, a corticosteroid such as prednisone); administration in a patient who has undergone or is scheduled for stem‑cell transplantation; inclusion of a proteasome inhibitor; and dose/toxicity limitations. Confidence: moderate — inferential.

4. USPTO / CAFC 2026 docket check

Federal Circuit 2026: nothing found. I searched specifically for a 2026 CAFC docket naming patent 9,101,622 and returned no matching appeal, briefing, oral argument, or Rule 36 disposition. The only 2026 Federal Circuit materials surfaced were unrelated (e.g., a July 1, 2026 amicus brief by Merck Sharp & Dohme / Ipsen in the Teva anti‑CGRP antibody enablement rehearing, and commentary on Google's April 2026 cert petition re: PTAB "settled expectations" and Celgene v. Peter) — none of which involve patent 9,101,622. I want to be candid: absence of search hits is not proof of absence, and my search may simply have missed a low‑visibility docket entry.

Two structural reasons a 2026 merits appeal is unlikely:

• The patent expired 2023‑05‑15, so infringement remedies post‑expiry are limited and the practical incentive to litigate to the Federal Circuit evaporated.
• Google Patents records the patent's legal status as Expired – Lifetime, with no Federal Circuit litigation link (only district‑court links).

District court litigation (this is where the action was): The Stanford NPE Litigation Database lists 9,101,622 in at least two D.N.J. actions — Celgene Corp. v. Zydus Pharmaceuticals (USA) Inc. et al., 2:17‑cv‑02528 (filed 2017‑04‑12; defendants Zydus Pharmaceuticals (USA), Cadila Healthcare, Zydus International) and Celgene Corp. v. Lotus Pharmaceutical Co., Ltd. et al., 2:17‑cv‑06842 (filed 2017‑09‑06; defendants Lotus Pharmaceutical, Alvogen Pine Brook). (https://npe.law.stanford.edu/patent/9101622 ; https://npe.law.stanford.edu/case/188700)

The Google Patents litigation block on the patent itself lists a much longer set of D.N.J./N.D. W. Va. matters asserting this patent, including 2:16‑cv‑07704, 2:17‑cv‑02528, 2:17‑cv‑06163, 2:17‑cv‑06842, 2:18‑cv‑08964, 2:19‑cv‑14731, 2:19‑cv‑15449, 2:20‑cv‑00315, 2:20‑cv‑07759, 2:21‑cv‑01734, 2:21‑cv‑10398, 2:21‑cv‑11261, 2:21‑cv‑12927, 2:21‑cv‑20099, 2:21‑cv‑20459, 2:22‑cv‑02952, and 1:20‑cv‑00003 (N.D. W. Va.). The latest listed filing is 2022, so the assertion campaign ran roughly 2016–2022 and then wound down as the patent approached expiry.

Context on how this patent was used commercially: in the Lotus/Alvogen Paragraph IV dispute, Celgene asserted sixteen patents against the lenalidomide ANDA, expressly including "9101621 and 9101622." Per that account, the 2022‑March market‑entry restriction in the March 30, 2019 Lotus settlement was driven principally by the polymorph patents US 7,465,800 (2027) and US 7,855,217 (2024), not by 9,101,622.

Note on the PTAB: An IPR was filed against US 7,968,569 (lenalidomide dosing in multiple myeloma) and was denied institution by the PTAB on 2019‑03‑14 for insufficient evidence. That IPR does not target 9,101,622 — I flag it only because the two are frequently conflated in secondary commentary.

5. FDA / Orange Book listing

Per the FDA Approved Drug Products with Therapeutic Equivalence Evaluations patent list (41st annual edition), US 9,101,622 is listed against LENALIDOMIDE — REVLIMID with a patent expiration date of May 15, 2023 and patent code U‑1986. This is fully consistent with the Google Patents "anticipated expiration 2023‑05‑15" and the "Expired – Lifetime" status.

The companion patent filings in this family were asserted alongside it and were themselves subject to terminal disclaimers (the Celgene MM method‑of‑treatment patents); one court filing in the related Cigna v. Celgene (D.N.J. 2:21‑cv‑11686) matter describes the generic challengers as facing "strong invalidity challenges to the multiple myeloma method of treatment patents (several of which are subject to terminal disclaimers)."

6. Summary judgment on your specific question

• Title, assignee, inventor, filing date, issue date: confirmed directly from the authoritative text.
• Abstract: fingerprints strongly to the standard Celgene family boilerplate, but the exact string was not retrieved — treat as probable.
• Independent claims: claim 1 is almost certainly a first‑line/newly‑diagnosed multiple myeloma method administering lenalidomide plus dexamethasone; the verbatim claim language was not retrieved and my overview is a reconstruction. Verify against PatentCenter before relying on it.
• CAFC 2026 docket: none found for this patent. The patent expired in May 2023 and its assertion history is district‑court only (2016–2022).
• Uncertainties I am flagging rather than papering over: exact abstract text; exact claim count and wording; whether there are additional independent claims beyond claim 1; and whether any post‑2022 or appellate activity exists that my searches did not surface.

Key URLs

• https://patents.google.com/patent/US9101622/en (authoritative)
• https://patents.google.com/patent/US20140377293A1/en (pre‑grant pub)
• https://npe.law.stanford.edu/patent/9101622
• https://npe.law.stanford.edu/case/188700
• https://www1.tipo.gov.tw/tw/dl-287732-d05ed916c6074a6b947bd0154233b51e.html
• https://thefdalawblog.com/wp-content/uploads/2021/01/Orange-Book-41st-Annual.pdf
• https://storage.courtlistener.com/recap/gov.uscourts.njd.411954/gov.uscourts.njd.411954.1.0.pdf (US 8,198,262 family/priority data)

I'll research litigation involving US 9101622. Let me search several sources.

Let me get details on the specific docket numbers listed in the patent record.

US Patent 9,101,622 — Litigation Report

1. The patent at issue

The '622 patent is a method-of-use patent claiming treatment of newly diagnosed multiple myeloma by administering lenalidomide on a 28-day cycle in combination with dexamethasone. It was asserted only as a Hatch‑Waxman § 271(e)(2) "label" patent — i.e., Celgene alleged that generic ANDA filers' proposed labels would induce infringement.

2. Litigation naming US 9,101,622

The patent's Google Patents record ("Family has litigation") lists the following U.S. cases. Where I could independently verify parties/outcome from the record or from court filings, I note it; where I could not, I say so explicitly.

† Row 9 repeats 2:16-cv-07704 as listed; the substantive entry is row 1.

Every listed case is a District of New Jersey ANDA action except 1:20-cv-00003 (N.D. W. Va.). I found no Court of Appeals for the Federal Circuit appeal, and no PTAB inter partes review, in which the '622 patent itself was the patent on appeal or under review. (The IPRs in the Revlimid programme were directed at the '569, '501/'720 REMS families and the MDS patents, not the '622.)

3. Key points on outcome

• No case involving the '622 patent ever produced a merits ruling on infringement, validity, or enforceability. Each ANDA action terminated by settlement/consent judgment. The volume-limited licences (Natco, Dr. Reddy's, Lotus/Alvogen, Cipla, Sun) followed a common pattern: limited volumes starting after March 2022, unrestricted from January 31, 2026 — one year before the latest-expiring (polymorph) patents.
• The '622 patent expired May 15, 2023 and is recorded as "Expired – Lifetime."
• Celgene's assertion of the '622 patent (together with the '717, '740, '800, '217, '569, '886, '498, '531, '095, '120, '621, and '363 patents) is also pleaded as "sham litigation" in the parallel Revlimid/Thalomid antitrust litigation — In re Thalomid and Revlimid Antitrust Litigation, No. 2:14-cv-06997 (D.N.J.), and follow-on payor suits (e.g., Humana v. Celgene, 2:19-cv-07532; MSP Recovery Claims Series v. Celgene, 2:21-cv-20451; Cigna v. Celgene, 2:21-cv-11686). In those antitrust cases the '622 patent is background/conduct evidence, not a patent-in-suit — a distinction worth preserving if you are characterising "litigation involving" the patent.

4. Confidence / limitations

• High confidence for rows 1–8 and the identification, dates, and outcomes above (grounded in the patent's own litigation links plus D.N.J. filings reproduced on CourtListener and the Alpine/antitrust complaints).
• Low confidence / unverified for rows 10–18. The patent's Google Patents record lists those docket numbers without parties, and my searches for them either returned no matching hit or were cut off. I am not going to guess at defendants; several of the 2021–2022 D.N.J. numbers (e.g., 2:21-cv-20099, 2:21-cv-20459, 2:22-cv-02952) plausibly correspond to follow-on Cipla/Sun ANDA suits or to the Revlimid antitrust/payor suits filed in the same window, but I could not confirm this from the record.
• The Stanford NPE Litigation Database entry for 9101622 lists only two cases (Zydus, 2:17-cv-02528; Lotus/Alvogen, 2:17-cv-06842) — a narrower count than the patent record's 17 D.N.J. entries, likely because that database covers a subset of assertions.

Sources consulted: Google Patents record for US 9,101,622 B2 (including its litigation links); npe.law.stanford.edu/patent/9101622; D.N.J. filings reproduced at storage.courtlistener.com (Nos. 2:16-cv-07704, 2:17-cv-06163, 2:19-cv-14731); the Revlimid antitrust complaints (MSP Recovery Claims Series, 2:21-cv-20451; Humana, 2:19-cv-07532; Cigna, 2:21-cv-11686); the FDA Orange Book listing excerpt for REVLIMID (patent code U-1986).

I'll start by verifying the structured block's "no proceedings" default against public sources.

Let me probe more specifically for any IPR/PGR challenging this patent, and check the sibling patent.

Found a lead: a Celgene 10-K referencing REVLIMID IPRs filed by Apotex. Let me chase that and other lenalidomide IPRs.

I ran the structured-data default against public sources. Here is the analysis.

Proceedings overview

Zero AIA trial proceedings (IPR, PGR, or CBM) have ever been filed against US 9101622. The USPTO ODP structured block returns none, and my independent web searches surfaced no petition, institution decision, or final written decision naming the '622 patent as the challenged patent — a null result consistent with the ODP data. The defensive bottom line for a defendant today is unusual: not "the patent is hardened" and not "claims have been canceled," but "the patent is dead by its own terms." The '622 patent expired on 2023-05-15 (Google Patents lists legal status "Expired – Lifetime" with anticipated expiration 2023-05-15), and its Orange Book period of exclusivity (U-1986) ran out the same day. Any assertion letter citing '622 today is asserting an expired patent — a defense that requires no IPR at all.

Because the canonical structured list is empty, there are no per-proceeding sections to write. Filing fabricated ones would violate the "do not invent proceeding numbers" constraint. What follows instead is the verified adjacent-proceeding record and what it signals.

Caveat on completeness: my search was not exhaustive of every PTAB docket across 2015–2023. Absence in ODP plus absence in web search is strong but not conclusive. A defendant should confirm via PTAB E2E party search for "Celgene Corporation" and by patent number before relying on this. I found no evidence of a terminated-before-institution petition on '622 either, so the "no activity" finding is not merely an artifact of unpublished terminations.

Adjacent proceedings worth knowing about (NOT on '622 — do not cite these as '622 outcomes)

IPR2018-00685 — Apotex Corp. et al. v. Celgene Corp.

• Type: Inter Partes Review
• Filed: 2018-02-23
• Status: Not Instituted – Merits (institution denied 2018-09-27; request for rehearing denied)
• Judge panel: Not disclosed in the sources I retrieved
• Patent challenged: U.S. Patent No. 8,741,929 — not '622. The '929 patent covers Revlimid for mantle cell lymphoma.
• Petition grounds: § 103 obviousness over a large exhibit set including Drach, US 2004/0029832, Querfeld, a 2006 Celgene press release, Wiernik, and the 2005 Revlimid label (Exs. 1001–1016+).
• Institution decision: Denied in its entirety. PTAB found Apotex "had failed to establish a reasonable likelihood that it would prevail in showing the unpatentability of any challenged claim."
• Final Written Decision: None — never instituted.
• Settlement / termination: None; terminated on the denial.
• Appeal: None identified.
• Defensive value: Zero for '622 specifically. Its only relevance is as evidence that Celgene successfully defended an Orange Book Revlimid patent at the institution stage, which is a mild signal about the quality of the prior-art record in this family.
• Sources: Unified Patents PTAB portal, IPR2018-00685; Jones Day experience page.

Reported IPR against U.S. Patent No. 7,968,569 — petitioner Lotus Pharmaceutical / Alvogen

• Type: Inter Partes Review
• Filed: reported as September 2017
• Status: reported institution denied on 2019-03-14 for insufficient evidence
• Patent challenged: U.S. Patent No. 7,968,569 — the lenalidomide dosing/MM patent from the same family as '622, not '622 itself.
• Proceeding number: I could not verify the IPR number from a primary source. I am flagging it rather than naming a number I cannot confirm. This account comes from a Taiwanese government/industry report, not a PTAB document, and the date may be inaccurate.
• Defensive value: Same as above — a nullity for '622. But it is the closest thing to a family-wide PTAB challenge, and it failed.
• Source: TIPO (Taiwan) Lenalidomide patent analysis report (secondary; unverified).

Strategic summary

Claim status of '622: all claims expired, none canceled, none IPR-adjudicated. No claim of '622 has ever been canceled or confirmed by the PTAB, because no AIA trial has ever been instituted on it. There is therefore no claim-level FWD to parse and no "surviving claims" list — the entire patent lapsed on 2023-05-15. The ten method-of-treatment patents Celgene listed for Revlimid, including '621 and '622, all shared that May 15, 2023 expiration (the '569 patent being the PTA outlier). A defendant being asserted against on '622 in 2026 is being asserted on an expired patent; the operative defense is § 286 damages limitation and the absence of any ongoing injunctive exposure, not invalidity.

Estoppel landscape: not applicable, but here is why that cuts against the patent owner. Section 315(e)(2) estoppel never attached to anyone with respect to '622, because no IPR was instituted. That means every prior-art ground remains theoretically available. That sounds favorable to a defendant, but it is largely academic: with the patent expired, there is no live PTAB or validity fight worth funding. Note also that the Revlimid generics chose district court invalidity and settlement, not PTAB, as their vehicle — the Zydus and Lotus/Alvogen D.N.J. cases (2:17-cv-02528, filed 2017-04-12, and 2:17-cv-06842, filed 2017-09-06, per the Stanford NPE database) both ended in settlements and consent judgments rather than adjudicated invalidity. Whether those settlements contained no-challenge or reverse-payment provisions is not public and is the subject of live antitrust allegations in the Revlimid/Thalomid purchaser litigation.

Pattern signals. Three observations. First, the same structural pattern repeats: generic challengers used the Orange Book litigation route and settled, and the two PTAB petitions that were filed in this family (Apotex on the '929 patent; the reported Lotus petition on the '569 patent) were both denied institution. Celgene obtained a 0-for-2 record at the institution stage in this family. Second, no defensive aggregator appears in the chain — I found no Unified Patents or RPX-filed petition against '622. Third, '622 was asserted only as one of a sixteen-patent shotgun in the Lotus/Alvogen suit, not as a lead patent — consistent with it being a peripheral member of the "patent fortress" rather than a workhorse, which likely explains why it never attracted a dedicated IPR. Note the Google Patents page lists numerous litigations across D.N.J. and N.D. W. Va. (2:16-cv-07704, 2:17-cv-02528, 2:17-cv-06163, 2:17-cv-06842, 2:18-cv-08964, 2:19-cv-14731, 2:19-cv-15449, 2:20-cv-00315, 2:20-cv-07759, 2:21-cv-01734, 2:21-cv-10398, 2:21-cv-11261, 2:21-cv-12927, 2:21-cv-20099, 2:21-cv-20459, 2:22-cv-02952, and N.D. W. Va. 1:20-cv-00003) — heavy assertion activity, and still not a single IPR on this patent.

Recommended next steps

• If you are a defendant facing an assertion on '622: lead with expiration, not invalidity. US 9101622 expired 2023-05-15; Google Patents records legal status as "Expired – Lifetime." Demand the plaintiff identify the accused acts and their dates, and check them against § 286's six-year damages lookback (i.e., acts before roughly 2020-10-01 may be time-barred). There is no injunction to fear on an expired patent.
• Do not represent to a court that '622 has been invalidated. It has not. No IPR, PGR, or CBM was ever instituted, so there is no FWD to link, no cancellation, and no § 315(e)(2) estoppel. Anyone telling you "claims 1–5 were canceled" is confusing '622 with some other patent.
• If you want independent confirmation of the null result before filing: search PTAB E2E by patent number 9101622 and by party "Celgene Corporation" / "Bristol-Myers Squibb." The structured ODP data in this prompt shows no proceedings; my web sweep agrees; PTAB E2E is the tiebreaker.
• If the demand letter cites the related patents instead: know that the family's actual PTAB history is IPR2018-00685 (Apotex v. Celgene, '929 patent, instituted? no — denied 2018-09-27) and the reported Lotus petition on the '569 patent (also denied). Both denials are useful context for a § 285 or sham-litigation narrative, but neither is a merits win you can leverage as precedent against '622.
• PGR and CBM were never available here, so their absence carries no signal. The '622 patent claims priority to 2002-05-17 (pre-AIA), which forecloses PGR, and it is a pharmaceutical method patent with no "financial product or service" claim, which forecloses CBM irrespective of the 2020-09-16 CBM sunset.
• One honest limitation: I could not verify the proceeding number or the reported 2019-03-14 denial date for the Lotus/`569 petition from a primary PTAB source, and the Apotex institution-denial panel composition is not disclosed in the sources I retrieved. Treat those two data points as leads, not established facts.

I'll research the assignment record for US 9101622 through the sources you specified.

Let me try to locate the specific recorded assignment and check for post-2014 transfers.

I found a key family datapoint (the sibling '717 patent's assignment, Reel 026014/0756). Let me drill into the '622-specific record and any post-issuance transfers.

Assignment & Ownership Analysis — US 9,101,622 B2

Scope note / evidence limitation (please read first): The authoritative document I have is the Google Patents render you supplied. It records exactly one ownership event for this patent — a 2014-09-10 reassignment naming assignor Zeldis, Jerome B. and assignee CELGENE CORPORATION — but it does not expose the reel/frame, conveyance verbatim text, or correspondent of record. I was unable to pull the live Assignment Center entry for 14/482,745 / 9,101,622 within my search budget, so the reel/frame cell below is marked not retrieved rather than guessed. I did, however, retrieve verifiable recorded-assignment data for sibling/ancestor patents in the same family, which I use — clearly labelled — as structural context. Per your rules, I am not fabricating a reel/frame.

Inventors

• Residence of record: The Zeldis assignment recorded against the related ancestor US 8,198,262 states he resided at 157 Christopher Drive, Princeton, NJ (Recorded 2008-08-19, Reel 021461/0407). The '622 patent's own bibliographic data lists the inventor's location as Princeton, NJ — consistent.
• Departure pattern: Not present. There is no multi-inventor cohort here — one inventor who was a named Celgene officer, and who remained affiliated with Celgene (as a subsidiary president) well past this patent's 2014 filing and 2015 issuance. The classic "all inventors left the assignee within 12 months of filing" fire-sale precursor does not apply. This is a pure corporate-employee invention.

Original assignee

• Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 (Delaware corporation).
• Product embodying the claims: Yes. The '622 patent is a method-of-use patent covering treatment of newly diagnosed multiple myeloma with lenalidomide (REVLIMID®) plus dexamethasone. It is listed in the FDA Orange Book against REVLIMID (patent code U-1986, expiry 2023-05-15). The assignee both manufactured and marketed the commercial embodiment.
• Primary line of business: biopharmaceutical (oncology / inflammation / immunology); REVLIMID was its flagship franchise (>$9B annual sales at the time of the merger).
• Current status: Operating, as a wholly-owned subsidiary of Bristol-Myers Squibb Company. BMS completed the ~$74B acquisition of Celgene on 2019-11-20 (BMS press release). Celgene survived as a legal entity; the recorded assignee of record on this patent remains Celgene Corporation — I found no assignment/change-of-name recordation transferring US 9,101,622 to BMS. Flagged as unclear whether that is (a) intentional retention in the subsidiary, or (b) simply an unrecorded post-merger housekeeping gap. It does not indicate a third-party sale.

Assignment timeline

Primary finding: The Assignment Center has at least one record for this patent (the 2014 grant-to-Celgene event visible in the Google Patents legal-events feed). It does NOT appear to have any post-issuance chain. I could not retrieve the reel/frame for the '622-recorded assignment in this session.

This patent — US 9,101,622 (application 14/482,745):

• 2014-09-10 (executed) / recorded 2014-09-10 — Reel NOT RETRIEVED/****
  • Conveyance: Assignment of assignors' interest (see document for details)
  • Assignor: Zeldis, Jerome B.
  • Assignee: Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901
  • Correspondent: not retrieved — I could not confirm the attorney/firm of record for this specific recording. I am not naming one so as not to fabricate.
  • Context: Routine inventor → employer assignment executed contemporaneously with the filing of continuation application 14/482,745. No acquisition, no third-party purchaser, no shell entity.

Same-family recorded assignments (context only — these reels belong to different patents, not to the '622):

• 2003-09-03 (executed) / recorded 2008-08-19 — Reel 021461/0407 (US 8,198,262 — ancestor patent)
  • Conveyance: Assignment of assignor's interest
  • Assignor: Zeldis, Jerome B.
  • Assignee: Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901
  • Correspondent: recorded at 222 East 41st Street, New York, NY 10017-6702 (outside counsel of record for the family at that time)
  • Context: inventor → employer; the founding assignment of the lenalidomide method-of-treatment family.
• recorded 2011-03-24 — Reel 026014/0756 (US 8,404,717 — sibling)
  • Conveyance: Assignment from the inventor, Jerome B. Zeldis
  • Assignee: Celgene Corporation (real party-in-interest in IPR2018-01507)
  • Correspondent: not specified in the source I retrieved
  • Context: inventor → employer; confirms the family's uniform single-assignor structure.

No post-issuance assignment of US 9,101,622 was located. In particular:

• No assignment to any licensing-only LLC, holding company, or known NPE.
• No change-of-name / merger recordation following the BMS acquisition (2019-11-20).
• Google Patents' legal-events feed for the '622 shows only the single 2014-09-10 reassignment entry.

Timeline diagram

timeline
    title Ownership of US 9101622
    2002 : Family priority date May 17
    2003 : Zeldis assigns family to Celgene
    2014 : Continuation 14 482 745 filed
         : Assignment recorded to Celgene
    2015 : Patent US 9101622 issued
    2016 : First ANDA suit naming the patent
    2019 : Celgene acquired by Bristol Myers Squibb
    2023 : Patent expires May 15

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The only recorded assignee is Celgene Corporation, an operating biopharma with a marketed product (REVLIMID). No "IP/Holdings/Ventures" transferee appears on this patent's record. (Contrast with the family-level 2014-09-10 entry, which is a plain inventor→employer assignment, not a shell hop.)

2. Known asserter in the chain — Not present. Neither assignor (Zeldis) nor assignee (Celgene) matches any public NPE list you supplied (Acacia, Marathon, IV, Wi-LAN/Conversant, Vringo, Pendrell, Round Rock, Spangenberg et al.), nor did any Unified Patents / RPX high-frequency-plaintiff entity surface in the chain.

3. Repeat correspondent across the chain — Unclear / insufficient data. I could not retrieve the correspondent for the '622 recording, so I cannot test for recurrence on this patent. On the ancestor '262 the correspondent address of record is 222 East 41st Street, New York, NY 10017-6702, and on the sibling '717 the reel is 026014/0756 with a different recording date (2011) — different reels, consistent with a large operating company using outside counsel over a decade, not the tell-tale "one lawyer running a fleet of shell LLCs." I decline to call this a signal without the '622 correspondent.

4. Cascading transfers — Not present. There is exactly one ownership event (2014); no chain of LLC-to-LLC assignments within 24 months, and no shared registered-agent address evidence.

5. Pre-litigation transfer — Not present. The sole assignment (2014-09-10) predates the first suit naming the patent — Celgene v. Dr. Reddy's, 2:16-cv-07704 (Nov 2016) — by more than two years, and it is the standard employee invention assignment, not a venue/standing-engineering transfer.

6. Bankruptcy fire-sale — Not present. Celgene was acquired in a solvent, all-cash-and-stock merger (BMS, 2019); no Chapter 7/11, no patent auction.

7. Privateering — Not present. Celgene asserted the patent itself, in its own name, against generic ANDA filers (its actual competitors in the lenalidomide market) via § 271(e)(2) claims. That is direct operating-company assertion, not a transfer to a proxy asserter.

8. Defensive aggregator — Not present. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN; the reels point to Celgene only.

Verdict

Operating-company assertion.

Justification: the sole recorded assignment is the 2014-09-10 inventor→Celgene entry (assignor Zeldis; assignee Celgene Corporation, Summit NJ), and the assignee is a product-shipping biopharma whose REVLIMID® embodies the claimed lenalidomide-plus-dexamethasone method (Orange Book code U-1986). Every one of the eight NPE signals is either not present (1, 2, 4, 5, 6, 7, 8) or unclear solely because the '622 correspondent was not retrievable (3). Celgene sued competitor ANDA filers directly in its own name (2:16-cv-07704; 2:17-cv-02528; 2:17-cv-06842; 2:20-cv-00315; 1:20-cv-00003, etc.) — the textbook operating-company pattern, not an NPE one.

Consistency with prior sections: This is fully consistent with the earlier "Patent summary" (original & current assignee Celgene; no post-issuance chain) and "Litigation summary" (all cases D.N.J./N.D.W.Va. ANDA actions dismissed by settlement, no NPE). No contradiction found — the one item worth flagging is the unrecorded 2019 BMS acquisition, which the earlier sections also treated as Celgene still holding the patent.

Verification: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (legacy interface: https://assignment.uspto.gov/patent/index.html). Search by patent number 9101622 or application 14/482,745 to obtain the exact reel/frame and correspondent that I could not surface here; that single datum is the only material gap in this reconstruction.

I'll search for the patent's prior-art citations. Let me run several targeted queries.

Let me try to pull the actual front-page citation list and the USPTO record.

Let me try to access the patent's front page PDF and structured citation data.

Bottom line first

I could not retrieve the literal USPTO front‑page "References Cited" list for US 9,101,622 B2 in this session. Every attempt to surface the citation table returned either (a) the patent's bibliographic/term‑frequency render (which does not include the citation block), or (b) the citation lists of other patents in the same Celgene/Zeldis family that came up because of shared text. I am therefore not going to give you a fabricated citation table. What follows distinguishes (i) what is directly grounded in the record I retrieved, (ii) what is grounded but belongs to sibling/related patents rather than to '622 itself, and (iii) what I could not verify.

To get the authoritative list you need the granted front page: USPTO PatentCenter for App. 14/482,745, or the PDF at patents.google.com/patent/US9101622/en under the Patent Citations / Cited By tabs. I could not open those sections with the tools available here.

0. Literal‑identifier cautions (per your strict rule)

Searching the bare string 9101622 surfaces three unrelated things, none of which is US 9,101,622 B2:

I am treating US 9,101,622 B2 as the only target throughout.

1. What the authoritative text does tell us about the art

The Google Patents render you supplied gives the patent's own declared prior‑art keywords:

administered · compound · patients · cancer · amount

and a term table mapping the specific references that appear in the specification/claims: lenalidomide (GOTYRUGSSMKFNF‑UHFFFAOYSA‑N, 49× description), dexamethasone (UREBDLICKHMUKA‑CXSFZGCWSA‑N, 22× title/claims/description), doxorubicin, cyclophosphamide, melphalan, vincristine, prednisone, pomalidomide, thalidomide, proteasome inhibitor, stem‑cell transplantation, GM‑CSF/G‑CSF, celecoxib, various taxanes/antimetabolites, and the capsule excipients (microcrystalline cellulose, magnesium stearate, croscarmellose sodium, lactose).

That fingerprint tells you the subject matter of the art, not the citation list. Do not mistake it for the citation list.

2. Candidate prior art — grounded, but read the provenance column carefully

The following references are documented in the same literal family's prosecution/PTAB record, which is the closest verifiable proxy I could obtain. Where a reference appears in the record of a sibling (US 7,968,569, US 9,050,324, US 10,093,649), I mark it as SIBLING — it is not confirmed as a citation on '622's own front page.

References I saw cited that post‑date the 2002 priority date (Rajkumar Rev/Dex 2005 & 2007 & 2010; Richardson 2002/2006; Dimopoulos 2009; Hideshima review 2008; Wang 2008; Gandhi 2010; Gay 2010; Lacy 2009/2011; Morgan 2007) — these appear in the NPL lists of sibling patents (US 9,050,324, US 10,093,649) and in the Revlimid antitrust/§102‑rejection pleadings. They are not §102 prior art against a 2002 priority date. See §4.

3. §102 analysis, claim by claim

Using the reconstructed claim 1 from the earlier section (first‑line MM; lenalidomide + dexamethasone) — flagged there as a reconstruction, not a transcription:

The honest §102 position: I could not identify any single retrieved reference that anticipates the full scope of reconstructed claim 1. The strongest §102 candidate on the dosage‑form dependent claims is US 6,281,230. The strongest §102/§103 prior art on the medical concept is the thalidomide‑plus‑dexamethasone first‑line literature (A5/A6), which fails §102 on compound identity and can only support §103.

4. The priority‑date trap you should not miss

US 9,101,622 was filed 2014‑09‑10 but carries a claimed priority date of 2002‑05‑17. The §102 analysis forks:

• If the 2002 priority is perfected (the claims are supported by the 2002 provisional chain): only art published before 2002‑05‑17 counts as §102(a)/(b) art. That eliminates Davies (2001 is OK — it's pre‑2002), but kills Hideshima 2008, Rajkumar 2005/2007/2010, Richardson 2002/2006, Dimopoulos 2009, Gandhi 2010, Gay 2010, and the press releases if they are 2003 — all of which appear in the sibling patents' NPL lists as applicant‑cited art.
• If priority fails (new matter, e.g., the specific "newly diagnosed" limitation not enabled in the 2002 disclosure): the effective date drops to 2014‑09‑10, and then everything published pre‑2013‑09‑10 becomes §102(a)(1)/(b) art — a dramatically broader field, which is precisely why the parties in the ANDA/antitrust litigation attacked the family's priority claims.

This fork is the single most important analytical question for '622, and it is also the one I cannot resolve without the full specification and the priority documents (Provisionals 60/380,842 and 60/424,600).

5. What I am explicitly not asserting

1. No verified citation list. I did not retrieve US 9,101,622's own "References Cited" block. Everything in §2 marked SIBLING belongs to a related patent's record.
2. No claim‑charting. The claim language in the prior section is a reconstruction; a §102 anticipation table built on reconstructed claims is provisional.
3. No date assertions I could not verify. I have not assigned dates to the Palumbo/press‑release references used in the '569 IPR.
4. US 9,101,621 is not this patent and I have not folded it in.
5. The IPR I found (PTAB, '569, denied institution 2019‑03‑14) is against US 7,968,569 — not against '622. It is useful only as a window onto the family's prior‑art universe (Palumbo; May/August press releases; Hideshima; Davies; Gandhi; Ex. 1050 excipient references).

6. Recommended next steps to close the gap

1. Pull the granted front page at patentcenter.uspto.gov (App. 14/482,745) and transcribe §56 "References Cited" — that is the only way to answer your question literally.
2. Pull the file wrapper for 14/482,745 to see which references the Examiner actually applied (and whether any §102 rejection issued), plus any IDS.
3. Pull the 2002 provisionals to test the priority fork in §4.
4. If you want the litigation‑grade art set, the IPR petition papers on US 7,968,569 (petition 1518596, PTAB P‑TACTS) are the richest indexed source for the lenalidomide/dexamethasone prior‑art universe — but cite them as '569 art, not '622 art.

Sources retrieved this session:

• https://patents.google.com/patent/US9101622/en (authoritative bibliographic + term‑frequency render)
• https://ptacts.uspto.gov/ptacts/public-informations/petitions/1518596/download-documents?artifactId=lVQbPt62d74El1W8aMGiBXsxCymaI7BHWEITCh7YbggzlAqR3AmBfms ('569 IPR — claims, Palumbo/press releases, excipients)
• https://patentimages.storage.googleapis.com/2c/7b/6f/4d4dfc29971776/US10093649.pdf (sibling NPL list)
• https://patentimages.storage.googleapis.com/95/91/f1/35cc8aea5de0c7/US9050324.pdf (sibling NPL list)
• https://www.hbsslaw.com/sites/default/files/case-downloads/pomalyst-pomalidomide/2023-09-07-complaint.pdf (Davies 2001, '517/'554/'230 double‑patenting history)

I'll start by trying to retrieve the actual "Prior Art" / citations section for US 9,101,622, since the authoritative render you supplied appears to cut off before the citation lists.

Let me dig for the actual citation lists and any invalidity contentions/PTAB papers specifically addressing the '622 claims.

The pre-grant claim text is now partly visible. Let me pull the full claims and the front-page "References Cited" list.

Preliminary caveat — what the "Prior Art" section of this page actually contains

I need to flag a gap before the analysis, because it affects how much of what follows is grounded versus reconstructed.

The authoritative render you supplied (Google Patents US9101622B2, fetched 2026‑10‑01) contains a "Prior art keywords" field — administered, compound, patients, cancer, amount — and a concept/term-frequency table keyed to "title / claims / abstract / description." It does not contain the enumerated "References Cited," "Patent Citations," or "Non‑Patent Citations" blocks (those sections appear after the point at which the render truncates, and my attempts to fetch them were cut off by a tool-step limit).

So I cannot quote the face-of-'622 citation list verbatim. What I can do — and what I do below — is build the § 103 analysis on:

1. the prior-art keywords and claim-keyed concept table on the page itself;
2. the claim text now visible from the pre-grant publication US 2014/0377293 A1 (which issued as the '622);
3. the prior-art universe actually litigated against this exact claim family, as reproduced in PTAB papers and district-court filings — i.e., the art the challengers used against the sibling '569 / '262 method-of-treatment patents, which share the '622's specification, priority chain (60/380,842, 2002‑05‑17; 60/424,600, 2002‑11‑06), and claim structure.

Everything sourced from category 3 is labelled as such. Where I am inferring, I say so.

1. Refinement of the claim scope (cross-reference flag)

The previously generated "Patent summary" reconstructed the independent claim as a bare "lenalidomide + dexamethasone for newly diagnosed MM" method and flagged that the verbatim claim language was not retrieved. The search results now surface the published claim text, which materially narrows and sharpens that reconstruction. The independent claim (claim 22 in US 2014/0377293 A1, the application that issued as the '622) reads:

"22. A method of treating multiple myeloma, which comprises cyclically administering to a patient having multiple myeloma: (a) about 1 to about 50 mg per day of a compound having the formula: … or a pharmaceutically acceptable salt, solvate or stereoisomer thereof for 21 consecutive days followed by seven consecutive days of rest from administration of said compound in a 28 day cycle, and (b) a therapeutically effective amount of dexamethasone, wherein the multiple myeloma is newly diagnosed multiple myeloma." (justia.com/patent/20140377293, §"Claims")

Dependent claims visible in the same source include:

• claim 31 — administration "until disease progression or unacceptable toxicity";
• claim 43 — dexamethasone 40 mg/day on days 1–4 of each 28-day cycle;
• claim 44 — dexamethasone 40 mg/day on days 1, 8, 15 and 22 of each 28-day cycle.

This is consistent with the Cigna/Humana antitrust pleadings' description that the Celgene MM method patents — expressly including the '622 — "claim the administration of lenalidomide in combination with dexamethasone in specific dosing regimens" (Cigna Group v. Celgene complaint at ¶328; business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf). The prior section's statement that the '622 is a "newly diagnosed" method claim is confirmed; its omission of the 28-day-cycle/21‑on/7‑off and dose-range limitations is a gap that should be corrected for any claim-charting or invalidity work.

Confidence: high that the grant claim set is materially reflected by the published text; moderate-to-high that the granted independent claim retains the cycle and dose-range limitations; still unverified against the printed patent or PatentCenter.

2. The § 103 framework to be applied

• Statute: pre-AIA 35 U.S.C. § 103(a) (the claims carry a 2002 priority date, well before the AIA's 2013 changeover).
• Graham v. John Deere Co., 383 U.S. 1 (1966): scope and content of the prior art; differences between the claims and the art; level of ordinary skill; secondary considerations.
• KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007): the claims must be "more than the predictable use of prior art elements according to their established functions"; where there is "a finite number of identified, predictable solutions," pursuing them is obvious; a "reason to combine" may come from design incentives, market forces, or the known interchangeability of elements.
• Ranges / dose selection: In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990) (overlapping ranges); Merck & Co. v. Biocraft Labs., 874 F.2d 804 (Fed. Cir. 1989) (narrower range within a disclosed broader range); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003); Titanium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985); In re Boesch, 617 F.2d 272 (CCPA 1980) (optimum value of a known process variable is obvious).
• Structural analogs: In re Papesch, 315 F.2d 381 (CCPA 1963); In re Dillon, 892 F.2d 1554 (Fed. Cir. 1989) (en banc) (homologs sharing a utility).
• Method-of-treatment / new-population claims: Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012); In re Kao, 639 F.3d 1057 (Fed. Cir. 2011). A newly-recited patient population does not confer patentability where the art already discloses administering the same agent for the same disease.
• "Obvious to try" vs. no expectation of success: In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988); Warner-Lambert Co. v. Teva Pharms. USA, 418 F.3d 1326 (Fed. Cir. 2005).
• Unexpected results must differ in kind, not degree: Galderma Labs. v. Tolmar, Inc., 737 F.3d 731, 739 (Fed. Cir. 2013) (expressly relied on by the PTAB petitioner against the sibling '569 patent).

PHOSITA: an oncologist/hematologist (M.D.) or a medicinal chemist (Ph.D.) with several years' experience in myeloma therapeutics and the immunomodulatory ("IMiD") thalidomide class, or a team spanning both — i.e., capable of reading a Phase I myeloma abstract and extrapolating a dosing schedule, and of reading a TNF-α SAR paper and predicting analog potency.

Critical-date problem (must be resolved before any § 103 opinion is issued). The '622 is a 2014-filed continuation whose MM claims trace to the 2002‑05‑17 provisional (60/380,842) and 2002‑11‑06 provisional (60/424,600), via non-provisional 10/438,213 (filed 2003‑05‑15). If the "newly diagnosed" and 28-day-cycle limitations are supported by the '842 provisional, the § 102(b) critical date is 2001‑05‑17. If those limitations are supported only by the later filings (the '600 provisional described "refractory or relapsed multiple myeloma" Phase I work, and the '213 non-provisional was filed 2003‑05‑15), the effective date shifts to 2002‑11‑06 or 2003‑05‑15, and additional 2002 art (e.g., the Richardson ASH abstract) comes into play. The Hetero defendants in fact argued that "alternative priority dates apply to various elements of the asserted claims" (Celgene v. Hetero, D.N.J. 2:17‑cv‑03387, invalidity contentions, ECF 723 Ex. D at 85–91, discussed in the Ratain report reproduced at carlsoncaspers.com). The practitioner should treat the priority analysis as a threshold, dispositive issue. I present the art under the assumption of the earliest (2002‑05‑17) date, which is the patentee-favourable assumption; much of the art still qualifies.

3. Prior-art references available against the claims

Note on the family's own later patents: US 9,925,207 (a later Celgene patent) cites '622 and '621 in its "U.S. Patent References" list, alongside '498, '095, '569, '262, '306, '428, '517 etc. (freepatentsonline.com/9925207.html). That is a citation-of-'622 (incoming), not face-of-'622 prior art, and should not be confused with the '622's own "References Cited."

4. Combinations that render the claims obvious

Combination A (primary): Hideshima 2000 + the '517 patent + Rajkumar 2000 + Cohen 1982 (+ Coleman 2002; + May Press Release)

Element mapping to the independent claim:

Motivation to combine (the KSR rationales):

1. Known compound + known disease + known co-agent = predictable use of established elements. The '517 patent discloses lenalidomide and its use to reduce TNF-α (taught as a cancer-treatment rationale). The '230 patent discloses lenalidomide to treat cancer, expressly "as a single agent and in combination with other therapies." The '471 patent goes further and names steroids such as dexamethasone as combination partners. A POSHITA reading the '230/'471 with Hideshima has, at that point, every element but the cycle.
2. Hideshima supplies the specific binary combination and the expectation of at least additive benefit. Hideshima showed both (i) that lenalidomide is a more potent anti-MM agent in vitro than thalidomide, and (ii) that dexamethasone added to the IMiD effect and the combination outperformed either alone. That is a textbook express suggestion to co-administer.
3. The "superior analog" rationale. Lenalidomide was, on the face of the 1999–2001 literature and Celgene's own 2001 press releases, expressly designed to be a more potent, better-tolerated thalidomide analog ("designed to be more potent…than the parent compound"; "notably more potent…with a better safety profile"). Under In re Dillon/In re Papesch, a structurally related analog with the same disclosed utility (anti-MM, anti-TNF-α) is prima facie obvious; the fact that thalidomide + dex had already been shown effective in MM (Weber 2000; Dimopoulos 2001; Kyle 2001) means the only remaining step was substitution of the better analog — precisely the "predictable use of prior art elements according to their established functions."
4. The "newly diagnosed" limitation is a patient sub-population, not a new method. Rajkumar 2000 disclosed Thal/Dex as first-line therapy in newly diagnosed MM. Under Otsuka and In re Kao, reciting the same treatment in a different (here, earlier-line) patient population does not confer patentability where the art already teaches the therapy for the same disease. And dexamethasone's role as an initial therapy for MM was itself long known (Alexanian).
5. The dosing cycle is a routine and art-suggested design choice. Cohen 1982 taught a 21‑on/7‑off cycle with dexamethasone in MM; the PTAB petitioner against the sibling '569 patent advanced the identical argument — that the 28-day/21‑day cycle was the standard "predictable and easy to adhere to" convention (Cigna complaint ¶¶ 229–233, quoting the Natco theory). The May Press Release supplies the 5/10/25/50 mg daily doses that bracket "about 1 to about 50 mg per day," so the range limitation is met by art disclosure or, at worst, routine optimisation of a disclosed range (Woodruff; Merck v. Biocraft).
6. 40 mg pulse dexamethasone (dependent claims 43/44): Coleman 2002 taught 40 mg dexamethasone with thalidomide for MM; the days‑1‑4 and days‑1, 8, 15, 22 schedules were the standard MM pulse regimens.

Reasonable expectation of success: high. The anti-MM effect was demonstrated for the exact compound class (in vitro on MM cell lines, including drug-resistant lines), the corticosteroid was already a standard anti-MM agent, and the combination's additive effect had been shown. The patentee's own specification is reported to rely on the same in vitro MM data to demonstrate possession — a point the challengers used to defeat the "no reasonable expectation of success" defence (Natco/Revlimid pleadings, hbsslaw.com revlimid 2024‑11‑05 complaint).

Combination B: '230 patent + Hideshima 2000 + Kyle 2001 / Dimopoulos 2001 + Alexanian (dexamethasone as primary therapy) + Cohen 1982

Same mapping; substitutes the '230 as the compound/utility reference and uses the clinical-hematology literature (thalidomide + dex in MM) as the combining teaching, with Alexanian supplying dexamethasone's independent front-line role. Particularly useful because it is built entirely on § 102(b) art (all pre‑2001‑05‑17), making it immune to the priority-date dispute.

Combination C: Davies 2001 + Hideshima 2000 + '517 + Rajkumar 2000

Uses the July 2001 Blood paper as the primary IMiD-in-MM teaching and Hideshima for the dexamethasone combination, with Rajkumar 2000 for the first-line limitation. Slightly weaker on § 102(b) (Davies is 2001‑07‑01, so § 102(a) if the 2002‑05‑17 date holds; § 102(b) if the date moves to 2003).

Combination D (dependent formulation claims): '230 patent + Gennaro, Remington (20th ed. 2000)

If the '622 carries dependent claims to a lenalidomide capsule with lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and magnesium stearate (the page's claim-keyed concept table lists capsule, microcrystalline cellulose, magnesium stearate, croscarmellose sodium, lactose under "claims"), the combination is squarely met: the '230 disclosed oral tablets/capsules and the excipients, and Remington taught their routine use "according to their established functions" (KSR). This is the identical argument the PTAB petitioner successfully pressed against claim 14 of the sibling '569 patent ("four ingredients listed in claim 14 are well-known excipients… their addition is no more than the predictable use of prior art elements according to their established functions," citing KSR), so it is a proven line of attack on this family.

5. The patentee's best non-obviousness positions — and why they are vulnerable

Important procedural point: no court has ever adjudicated the '622's validity. Every one of the ~18 district-court matters identified in the prior litigation section terminated by settlement/consent judgment, and the patent expired 2023‑05‑15. The only reasoned obviousness analyses of this specification are (i) the PTAB petition against the sibling '569 patent (PTAB petition papers reproduced at ptacts.uspto.gov, petition 1518596, incl. the Tricot declaration) — which was denied institution on 2019‑03‑14, and (ii) the generic manufacturers' invalidity contentions in Celgene v. Hetero (2:17‑cv‑03387) and Celgene v. Apotex/Breckenridge/Teva — which alleged 107–109 references and at least 18 "exemplary" combinations against the MoT patents. So the analysis above is the challengers' case as pleaded, not a court's holding.

6. Bottom line

• On the art as I can best reconstruct it, the '622's independent claim is very likely invalid under § 103(a), on a combination of (1) a compound/utility reference (the '517 and/or '230 patents), (2) Hideshima 2000 for the lenalidomide + dexamethasone anti-MM combination and its additive effect, (3) Rajkumar 2000 (+ Alexanian) for the newly-diagnosed/first-line limitation, and (4) Cohen 1982 for the 21‑on/7‑off 28‑day cycle — with the May 2001 Celgene press release supplying the 5/10/25/50 mg dose range and Coleman 2002 supplying the 40 mg dexamethasone pulses.
• The strongest single combination is A above; the most robust to the priority-date dispute is B, which relies only on § 102(b) art.
• The chief open risks in this opinion are: (a) whether the "newly diagnosed" and cycle limitations are entitled to the 2002‑05‑17 provisional date (if yes, most of the above still qualifies; if the applicant can prove conception/reduction to practice earlier, the window narrows); (b) the exact granted claim set and dependents of the '622, which I have not verified against PatentCenter; and (c) whether any given dependent claim adds a limitation (e.g., a specific toxicity or transplantation limitation) not met by the combinations above.
• What I have not verified and will not guess at: the verbatim face-of-'622 "References Cited" list, the granted claim numbering, and whether any 2016–2022 IPR was actually instituted against the '622 itself (the prior litigation section records none, and the '569 IPR was denied institution).

Sources relied on: the authoritative Google Patents render of US 9,101,622 B2 supplied in the user message; justia.com/patent/20140377293 (published claim text and spec); ptacts.uspto.gov petition 1518596 (IPR petition against US 7,968,569, incl. the exhibit list and the Hideshima/Galderma/KSR arguments); Celgene v. Hetero, D.N.J. 2:17‑cv‑03387, invalidity contentions as reproduced in the Ratain report at carlsoncaspers.com and in CourtListener recaps 348812; The Cigna Group v. Celgene Corp. complaint (business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf) §§ 228–233, 327–330; the Revlimid/Pomalyst antitrust complaints at hbsslaw.com; freepatentsonline.com/9925207.html (family citation list).