US 6561977

I'll verify the identifiers and look for docket/litigation info before summarizing.

Let me pull the actual claim text for the '977 patent itself and check for any 2026 appellate activity.

US Patent 6,561,977 — Analyst Summary

Identifier interpreted literally: US 6,561,977 B2 (no normalization; the "B2" kind code is as listed). One adjacent but different patent, US 6,755,784, is a later continuation of the same application chain and appears frequently in the same sources — I flag below where a result I found actually belongs to '784 rather than '977.

Bibliographic data

Terminal disclaimer note: prosecution records in the family show terminal disclaimers tying later filings to the full statutory term of 6,315,720 and 6,561,977 (see the Celgene v. Hetero D.N.J. 2:17-cv-03387 record, ECF 250-30), which is consistent with the Oct. 23, 2020 expiration rather than a 2021/2023 date.

Abstract (verbatim from the patent)

"Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved."

Independent claim — plain language

The full claim set was not included in the authoritative text I was given (the specification text supplied cuts off in the "DETAILED DESCRIPTION" before the claims), so I retrieved the issued claim text separately. Claim 1 reads (as displayed by DrugPatentWatch, last updated June 23, 2026):

"1. A method for delivering a drug to patients in need of the drug while restricting access to the drug by patients for whom the drug may be contraindicated, said method comprising permitting prescriptions for the drug to be filled by a pharmacy only after the pharmacy has retrieved an approval code for the prescription from a computer readable storage medium, wherein generation of the prescription approval code comprises the following steps: a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for the drug; b. defining a set of information to be obtained from a patient, which information is probative of the risk that an adverse side effect is likely to occur if the drug is taken by the patient; c. in response to the information set, assigning the patient to at least one of the risk groups and entering the patient, the information and the patient's risk group assignment in the medium; d. based upon the information and the risk group assignment, determining whether the risk that the adverse side effect is likely to occur is acceptable; and e. upon a determination that the risk is acceptable, generating the prescription approval code to be retrieved by the pharmacy before the prescription is filled."

Plain-language overview of claim 1: A method of controlled drug distribution in which a pharmacy may fill a prescription only if it first pulls a "prescription approval code" from a database. That code is only generated if the system has (a) pre-defined patient risk tiers for the drug, (b) collected patient information bearing on the likelihood of an adverse side effect, (c) assigned the patient to a risk tier and stored the patient, the information, and the tier, (d) affirmatively judged the residual risk "acceptable," and then (e) issued the code. In substance it is a risk-stratified, database-gated dispensing workflow — the "Enhanced S.T.E.P.S."-style architecture Celgene built around thalidomide.

Dependent claims I could verify exist but whose full text I did not retrieve: claims 2 (register the prescribing physician in the medium), 3 (register the pharmacy), 4 (counsel the patient per risk group), 9 (information includes diagnostic testing results), 13–15 (side effect arises in the patient / in a fetus carried by the patient / in a recipient or that recipient's fetus), and 17 (define a second periodic information set, obtain it, and enter it in the medium). Claim 17 depends from claim 1, so at least one further independent claim may exist in the set — I could not authoritatively confirm the total claim count or whether claim 28 is a second independent claim in '977. (In the sibling '784 patent the claim set is 34 claims, and the related '720 patent has independent claims 1 and 28 — do not assume '977 shares either structure.)

Literal-difference flag: the parallel claim 1 of the later '784 patent substitutes "received an approval code for the prescription from a computer readable storage medium," whereas '977 recites "retrieved … from." Under your no-auto-correction rule these are distinct strings in distinct patents and should not be interchanged.

Notes on your specific search requests

Litigation found (all district court; no 2026 appellate docket located):

• The '977 patent was asserted in a long series of D.N.J. Hatch-Waxman suits: 2:07-cv-00286, 2:07-cv-04050, 2:07-cv-05485, 2:10-cv-05197, 2:15-cv-00697, 2:17-cv-06842 (Lotus/Alvogen, ANDA 210480), 2:18-cv-00461 (Apotex), 2:18-cv-06378 (Dr. Reddy's), 2:18-cv-11518, 2:18-cv-13477 (Hikma/West-Ward), and Texas E.D. 2:18-cv-00461.
• These were resolved by consent judgments/settlements rather than judgment on the '977 merits — e.g., the Lotus/Alvogen consent judgment of March 29, 2019 (ECF 109) lists 6,561,977 among the Patents-in-Suit; Dr. Reddy's entered a consent judgment Sept. 17, 2020.
• Important distinction: the celebrated Celgene Corp. v. Peter appeal (Fed. Cir., aff'g IPR2015-01092 / Coalition for Affordable Drugs VI v. Celgene) held unpatentable claims of the '501 patent (6,045,501) and the '720 patent (6,315,720) — i.e., the parent and the Elsayed reference — not 6,561,977. The Supreme Court cert. appendix in Celgene Corp. v. Peter (No. 19-1074) confirms the claim 1 text attributed to those patents. Do not attribute that affirmance to '977.
• The '977 patent is Orange Book–listed with an expiration of Oct. 23, 2020 (use codes vary by edition/product: U-371, U-694, U-731, U-1210 appear across different Orange Book editions and different NDAs, including THALOMID and REVLIMID listings). It also appears in the Oct. 2020 "REMS patents" expiration cluster referenced in later antitrust pleadings (The Cigna Group v. Celgene, D.N.J. 1:25-cv-05237-ER, filed June 24, 2025, ¶379).

Uncertainty / what I could not verify (stated explicitly rather than filled in):

1. I found no CAFC 2026 docket involving US 6,561,977. My searches for Celgene 2026 Federal Circuit activity returned only unrelated items (a 2026 weekly Federal Circuit case-summary page, a BMS filing referencing 2026 tariffs, and past CAFC decisions from 2019/2021). This is not proof that none exists — treat it as "not found," not "confirmed absent." Given that the patent expired Oct. 23, 2020 and the known district court cases terminated in settlement by 2020–2021, a 2026 appeal squarely on '977 would be unusual, but I could not complete a direct CAFC/PACER docket query, and my later search calls were cut off before returning results.
2. Authoritative claim set. I could not confirm the total number of claims in '977 or the full text of every independent claim. The claim 1 text above comes from a secondary aggregator (DrugPatentWatch), not from the USPTO PatentCenter full-text or the printed patent. For anything claim-determinative, pull the patent PDF or PatentCenter record directly.
3. The full text you supplied is the specification only (it ends mid-sentence in the detailed description); it does not include the claims, so I did not rely on it for claim scope.

I'll research the litigation history for US Patent 6561977. Let me search multiple sources.

Let me dig deeper into the specific cases and parties.

Let me look up the specific case numbers listed on the patent record.

Litigation Involving U.S. Patent No. 6,561,977

Bottom line: Yes — litigation is known, and it is substantial. U.S. 6,561,977 ("the '977 patent") is one of Celgene's "REMS" patents (risk‑evaluation/monitoring‑system method claims) that was Orange‑Book listed for both THALOMID (thalidomide) and REVLIMID (lenalidomide) and was asserted in Hatch‑Waxman ANDA litigation in the District of New Jersey. It expired October 23, 2020 and is now "Expired – Lifetime."

Important methodological caveat, stated up front: Google Patents' "Family has litigation" panel aggregates suits involving the entire '720 patent family ('720, '977, '784, '399, '018, '531, '886, etc.). Appearing on that list does not by itself prove the '977 patent was asserted in each case. Below I separate cases where I could confirm '977 was actually pleaded from family-level cases I could not confirm. Where I could not verify, I say so rather than guess.

A. Cases where the '977 patent was expressly asserted

1. Celgene Corp. v. Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook, LLC

• Court / jurisdiction: U.S. District Court for the District of New Jersey
• Case number: 2:17‑cv‑06842 (a second, related suit is 2:18‑cv‑11518)
• Filed: September 6, 2017 (following Alvogen's Paragraph IV certification on ANDA No. 210480 for generic REVLIMID/lenalidomide)
• Plaintiff: Celgene Corp. Defendants: Lotus Pharmaceutical Co., Ltd. (Taiwan) and Alvogen Pine Brook, LLC
• '977 expressly asserted? Yes. The complaint alleged infringement of 16 patents including the '977 patent ('517, '720, '977, '784, '740, '800, '217, '569, '886, '717, '498, '531, '095, '120, '621, '622).
• Outcome / status: Settled. Consent judgment and injunction entered March 29, 2019, barring Lotus/Alvogen from marketing generic lenalidomide until expiration of the patents‑in‑suit; under the confidential settlement, volume‑limited generic entry after March 2022, uncapped from January 31, 2026. (BMS issued a public statement on the settlement.) Proceedings on the REMS patents were earlier bifurcated and stayed pending Celgene's appeal of the PTAB's invalidation of the related '720 patent.

2. Celgene Corp. v. [Dr. Reddy's Laboratories, Ltd.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Ltd.) and Dr. Reddy's Laboratories, Inc.

• Court / jurisdiction: U.S. District Court for the District of New Jersey
• Case number: 2:18‑cv‑06378
• Filed: April 12, 2018 (per IP‑NAVI dispute record); complaint/amended complaint docketed in May 2018
• Plaintiff: Celgene Corp. Defendants: Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (India)
• '977 expressly asserted? Yes. This suit was the REMS‑patent action and asserted US 6,315,720; US 6,561,977; US 6,755,784; and US 8,626,531 (generic lenalidomide capsules).
• Outcome / status: Settled. Celgene/Bristol‑Myers Squibb announced settlement September 17, 2020 — volume‑limited generic lenalidomide sales after March 2022, uncapped from January 31, 2026.
• Related but distinct: The earlier Celgene v. Dr. Reddy's suits, Nos. 2:16‑cv‑07704 and 2:17‑cv‑05314, asserted the crystal‑form ('800/'217), method‑of‑use, and other patents — not the '977 REMS patent (per the FDA ANDA 209348 approval letter).

B. Family litigation listed on the patent's Google Patents record (no confirmed '977 assertion)

Google Patents lists the following cases under "Family has litigation" for the '977 family. I could not independently confirm in the time available that the '977 patent itself was pleaded in each, so treat these as family/related suits to verify against PACER:

The source for this list is the patent's Google Patents page (https://patents.google.com/patent/US6561977/en, "Family has litigation"), which also links a Darts‑IP "first worldwide family litigation" record (family 24787895). Note also that the REVLIMID‑related patents Celgene asserted against Lotus/Alvogen included '886 and '531, which were not Orange‑Book listed — a point the generic manufacturers raised.

C. Related antitrust follow‑on litigation referencing the '977/REMS patent family

These are not patent‑infringement suits on the '977 patent's claims, but the '977 patent appears as part of the Orange‑Book/REMS portfolio at the center of the alleged "pay‑for‑delay"/sham‑litigation scheme:

• In re REVLIMID and THALOMID Purchaser Antitrust Litigation (D.N.J.) — direct/indirect purchaser and insurer classes; alleges Celgene/BMS used the REMS patents and serial settlements (Natco, Dr. Reddy's, Lotus/Alvogen, Cipla, Sun, Hetero, etc.) to delay generic lenalidomide/thalidomide. (See D.N.J. pleadings, e.g., Nos. 2:19‑cv‑…, 2:20‑cv‑…; complaints at hbsslaw.com and business.cch.com.)
• Mylan Pharmaceuticals Inc. v. Celgene Corp. / related Revlimid antitrust actions.
• The Cigna Group v. Celgene Corp. and Humana-related complaints — both recite the '977 family (REMS) patents among the alleged exclusionary portfolio.

D. PTAB / post‑grant proceedings

• The PTAB invalidated the lead REMS patents — notably U.S. 6,315,720 — as obvious; the Federal Circuit affirmed on July 30, 2019. (IPR2015‑01103 and related proceedings, e.g., CFAD VI v. Celgene, involve the '720 patent.)
• I could not confirm any IPR that directly challenged claims of the '977 patent itself. Given the '977 patent's October 23, 2020 expiry and the invalidation of the sibling '720 patent, such challenges may have been mooted.

Summary of confirmed matters

If your purpose is FTO, validity, or damages analysis, I recommend pulling the actual dockets in the two confirmed cases above (and, if relevant, the Natco and Sun cases) via PACER/CourtListener to confirm which claims of the '977 patent were asserted, and to obtain the settlement license terms, which are largely confidential. I can also retrieve the specific complaint PDFs if you want claim‑by‑claim assertion details.

Proceedings overview

US 6,561,977 — 0 AIA trial proceedings on file. The structured ODP feed in my prompt returns no IPR, PGR, or CBM proceeding naming this patent, and my web checks surfaced none either (no petition, no institution decision, no FWD, no termination, no appeal tied to the '977). So the breakdown is: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0 — for this patent specifically.

That is not the same as "the patent is hardened." The '977 is a direct continuation of the application that issued as US 6,315,720 (the '720 patent), and the '720 was wiped out claim-by-claim in IPR and affirmed on appeal. So the honest defensive posture is: the '977 was never itself tested at the PTAB, but the parent patent claiming the same disclosure was invalidated as obvious using art that maps onto the '977's claims — and the '977 expired on 2020-10-23. Also, the '977 has been litigated to death in Hatch‑Waxman suits and is now expired, so nobody had a live incentive to spend $500K on an IPR against it. Treat "no IPRs" here as "the patent retired before it got hit," not "the patent survived attack."

Proceedings on US 6,561,977

None. There is no proceeding to itemize for this patent number. I will not manufacture case numbers, panels, or outcomes — the constraint against fabrication controls, and inventing an IPR caption for the '977 would be the single worst thing I could do for a defendant relying on this memo.

Adjacent family proceedings (NOT on the '977 — read the labels carefully)

These are the PTAB matters a defendant will actually care about, because the '977 shares a specification and priority chain with the patents that were killed. Do not cite any of these as "an IPR on 6,561,977" in a brief — a footnote that does that is sanction-bait.

IPR2015-01102 & IPR2015-01103 — Coalition for Affordable Drugs VI LLC v. Celgene Corp.

• Type: Inter Partes Review
• Patent challenged: US 6,315,720 (the '720 patent) — the parent of the '977 (the '977 is a continuation of App. Ser. No. 09/694,217, which issued as the '720, per the '977's own cross-reference).
• Filed: 2015-04-23
• Status: FWD issued; claims held unpatentable; affirmed on appeal.
• Judge panel: the public docket listing for IPR2015-01103 names APJs Grace Karaffa Obermann, Jacqueline Wright Bonilla, Michael Kim, Michael Tierney, Tina Hulse and Toni Scheiner on the case; treat that as the case roster (interlocutory orders included) rather than a confirmed FWD panel. I could not verify the precise three-judge FWD panel from the sources retrieved — flagging the gap rather than guessing.
• Petition grounds: obviousness (pre-AIA § 103), claims 1–32, over the combination of Powell, Dishman, Cunningham, Mundt, Mann, Vanchieri, Shinn, Linnarsson, Grönroos, Soyka, Hamera, Kosten, and Menill.
• Institution decision: instituted 2015-10-27 (Paper 20/21) on the sole ground raised.
• Final Written Decision: 2016-10-26 (IPR2015-01103, Paper 76; parallel FWD in IPR2015-01102). The Board held claims 1–32 unpatentable as obvious. Representative reasoning: the claims are directed to "an improvement of an existing drug distribution method that provides an approval code after a prescriber has prescribed the [drug]," i.e., the preprescription-assessment/approval-code concept was the obvious next step over the clozapine-registry and Accutane-pregnancy-prevention art.
• Rehearing: Celgene moved for rehearing; the Board granted the request as to one claim of the '720 (2017-09-08) and denied it as to the '501 (same date, per Celgene's SEC disclosure).
• Appeal: Celgene appealed; Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) (decided 2019-07-30; appeal nos. 18-1167 and 18-1171). The Federal Circuit affirmed the Board's determination that claims 1–9 and 11–32 of the '720 patent are unpatentable as obvious over the asserted prior art, and rejected Celgene's retroactivity/Takings Clause challenge to IPRs on pre-AIA patents. Claim 10 of the '720 is expressly outside that affirmed list — consistent with the granted rehearing having removed it from the invalidity judgment. I would verify claim 10's precise final status in Paper 79 before relying on it; the sources I retrieved do not state the rehearing outcome claim-by-claim.
• Defensive value: For the '977, the value is structural, not precedential. Same specification, same inventors, same October 2000 priority — so a § 103 theory built on Powell/Dishman/Cunningham is the obvious starting point for a district-court § 282 attack on the surviving '977 claims. But there is no estoppel, no issue preclusion, and no PTAB finding on the '977's own claims. Its claim language differs (the '977 claims a risk-group/approval-code architecture), so you must do the element-by-element mapping yourself.

IPR2015-01092 — Coalition for Affordable Drugs VI LLC v. Celgene Corp.

• Type: Inter Partes Review
• Patent challenged: US 6,045,501 (the '501 patent) — earliest family patent, not the '977's parent, but the same S.T.E.P.S. disclosure lineage.
• Filed: 2015-04-23
• Status: FWD issued 2016-10-26 (Paper 73); all 10 claims held unpatentable as obvious over Powell + Mitchell + Dishman. Rehearing denied 2017-09-08; affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019).
• Defensive value: Again structural only. It establishes that the Federal Circuit has already blessed the Powell/Mitchell/Dishman obviousness theory for this specification family, which is the strongest thing a '977 challenger has going for it — and it is still not a judgment about the '977's claims.

IPR2015-01096 — Coalition for Affordable Drugs VI LLC v. Celgene Corp.

• Type: Inter Partes Review (a further CFAD petition filed 2015-04-23 in the same campaign; directed at a Revlimid compound/method patent, not the '977).
• Status: I could not confirm from the retrieved sources whether this one was instituted or denied, or its exact patent number. Do not cite it without pulling the docket. I am listing it only so you know it exists and can complete the check.

Sanctions side-show (relevant to the "pattern signals" question)

Celgene moved for sanctions against CFAD in the thalidomide/Revlimid IPRs, arguing an improper profit/short-selling motive. The Board denied the motions, reasoning that "[p]rofit is at the heart of nearly every patent and nearly every inter partes review," that the IPR statute does not limit petitioners to competitors, and that the AIA was designed to "encourage the filing of meritorious patentability challenges, by any person who is not the patent owner." This did not produce anything about the '977, but it explains why nobody was deterred from filing.

Strategic summary

Canceled vs. sustained vs. untested — as to the '977 itself: entirely UNTESTED. No claim of US 6,561,977 has been canceled, confirmed, or construed by the PTAB. Everything the Board did was to the '501 and the '720. If a demand letter or complaint asserts the '977, no PTAB disposition exists that you can hand a judge and say "this claim is already dead." You would be arguing fresh. The good news is that the patent's whole family architecture collapsed in the IPR campaign: the parent '720 and the foundational '501 both fell on § 103, and the Federal Circuit affirmed. The '977 sits on the same specification as the '720 — a continuation of the very application that produced it — so the same Powell/Dishman/Cunningham art is available, and there is no PTAB rebuttal of that art that binds you.

Estoppel landscape. § 315(e)(2) estoppel attaches only to CFAD VI, its real parties in interest and privies, and only in proceedings challenging the '501 and '720. It does not estop anyone with respect to the '977, and it does not estop you. Two practical points: (1) if you have been served with a complaint alleging infringement of the '977, your § 315(b) one-year window to petition runs from service — but note the patent's expiry; (2) because the '977 has an effective filing date in 2000, PGR is unavailable (pre-AIA patent) and CBM review is gone (sunset 2020-09-16), so IPR is the only AIA vehicle left. Also note the Board applies Phillips construction to expired claims, not BRI — a move that generally narrows, not broadens, patent-owner leverage.

Pattern signals. One petitioner (Kyle Bass's Coalition for Affordable Drugs VI LLC) ran an entire IPR campaign against the Celgene S.T.E.P.S./REMS portfolio — the '501 and multiple petitions against the '720. It did not file on the '977. The generics (Natco, Lannett, Lotus/Alvogen, Dr. Reddy's, Breckenridge, Aurobindo) copied Paragraph IV certifications against the '977 but, as far as the retrieved record shows, litigated it in district court rather than at the PTAB — and in Celgene v. Lotus (D.N.J. 2:17-cv-06842) the parties stipulated on 2019-02-22 to bifurcate and stay the REMS patents (6,315,720, 6,561,977, 6,775,784, 8,315,886, 8,626,531) while the '720 IPR ran, then resolved everything by consent judgment on 2019-03-29. In other words, the '977 was parked behind the '720 IPR and then settled — the classic reason a patent never develops PTAB history. Separately, this patent family is now the subject of antitrust/Walker-Process-style allegations in the MSP Recovery Claims / direct-purchaser suits (D.N.J. 2:21-cv-20451 and related) alleging the distribution patents were fraudulently procured and listed; that is a different attack vector (unenforceability, § 282) and, given expiry, likely a more productive one than an IPR. No defensive aggregator appears in the chain — the litigations on the Google Patents "family has litigation" list are all Celgene-as-plaintiff D.N.J./E.D. Tex. matters and Unified Patents data pulls, not Unified-financed IPRs.

One expiry caveat that dominates everything. US 6,561,977 expired 2020-10-23 (listed "Expired - Lifetime"). Any infringement recovery is limited to pre-expiration conduct within the § 286 six-year lookback from the complaint date. That changes the cost/benefit of an IPR dramatically: you would be paying to challenge claims that can only support back damages, on a patent whose parent was already invalidated and whose owner is now dealing with antitrust exposure over the same portfolio.

Recommended next steps

1. Do not assert "PTAB invalidated the '977." It did not. If you are drafting an invalidity contention, cite IPR2015-01092 (Paper 73, 2016-10-26), IPR2015-01102/01103 (Paper 76, 2016-10-26) and Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) for the proposition that this specification family was held obvious over Powell/Mitchell/Dishman — and then do your own claim-chart mapping to the '977's risk-group and approval-code limitations. The '977's claim set is not identical to the '720's, so the Board's analysis is persuasive, not preclusive.
2. Pull the primary documents before filing anything. Retrieve IPR2015-01092, IPR2015-01102 and IPR2015-01103 in the USPTO PTAB End-to-End system (https://ptacts.uspto.gov/ptacts/) and confirm: (a) the FWD panel composition; (b) the exact claim-level disposition of claim 10 of the '720 after the 2017-09-08 rehearing grant (Paper 79) — the Fed. Cir. affirmance covers claims 1–9 and 11–32 only, and I am not willing to state claim 10's final status without the paper; (c) whether IPR2015-01096 was instituted, denied, or terminated, and against which patent.
3. If you have been sued on the '977 and want to petition: the § 315(b) clock is one year from service, IPR is the only available AIA vehicle (no PGR — pre-AIA; no CBM — sunset), and you must account for the 2020-10-23 expiry and the Phillips standard. The statutory trial deadline is one year from institution (35 U.S.C. § 316(a)(11)), extendable only for good cause.
4. If you were not sued — i.e., this is a licensing demand: the expiration date is your first line. There is no injunctive exposure, the damages tail is limited by § 286, and the parent claims on the same disclosure are canceled. Price the demand accordingly.
5. Close the file with a plain statement. Confirm in your memo that, as of 2026-10-01, the ODP feed and public sources show zero AIA trial proceedings on US 6,561,977. The absence is a signal about litigation economics and expiry, not about validity — and the patent's family posture is anything but strong.

Caveat on sourcing: the PTAB docket details above (case numbers, filing dates, FWD dates, asserted art, affirmance) are drawn from web search of public dockets and secondary sources. The Google Patents page for US6561977 — the authoritative text in my prompt — lists only district-court litigation and no PTAB proceedings, consistent with the ODP result. I have flagged the two items I could not verify (the exact FWD panel, and claim 10's post-rehearing status) rather than filling them in.

I'll reconstruct the assignment record from primary sources. Let me start with the USPTO Assignment Center and cross-references.

Let me dig deeper into the assignment records and any post-issuance transfers.

I found a key primary document showing the recorded assignment data. Let me pull the exact reel/frame entries and check for any post-Celgene transfers.

I have enough primary-record material now (USPTO Notices of Recordation reproduced in the D.N.J. 2:17-cv-03387 exhibit and in Celgene's own IPR papers) to reconstruct this chain. Two caveats up front, stated rather than papered over:

1. I could not load the Assignment Center UI directly (my search budget was exhausted before a direct docket query), so reel/frame values below come from USPTO Notice-of-Recordation documents reproduced in court/PTAB filings. One recurring discrepancy is flagged in the timeline.
2. This patent's chain is effectively a single link (inventors → Celgene). Everything downstream of that is context, not assignment data.

Inventors

Both are named as "joint inventors" in the recorded assignment instrument (USPTO Notice of Recordation, Reel 013982/0697, reproduced at D.N.J. 2:17-cv-03387, ECF 250-30, p. 53 of 209). The assignment text does not state an employer for either inventor. Both were New Jersey residents a short drive from Celgene's Warren, NJ headquarters, and the application was assigned to Celgene as original assignee — consistent with employment — but that is inference, not record evidence, and I am not asserting it as a finding.

Unusual patterns: none detected. There is no evidence in the record of either inventor departing Celgene within 12 months of filing, nor of any subsequent inventor-side assignment. To the contrary, Williams and Kaminski appear as the co-inventor pair across the entire Celgene S.T.E.P.S./RevAssist family ('720, '977, '784, '399, '018, '566, '886, '531), which is the signature of a long-tenured in-house pair, not a portfolio being spun out from under departing staff. (This is a negative finding from the family inventor lists I retrieved; I did not run employment records.)

Original assignee

Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059 — "a corporation of Delaware" (so recited verbatim in the assignment instrument).

• Product embodying the claims: yes, squarely. The '977 patent is Orange Book–listed against THALOMID (thalidomide; NDA 020785) and REVLIMID (lenalidomide; NDA 021880), with a listed expiration of Oct 23, 2020 and use codes that vary by Orange Book edition/product — U-371 (Thalomid), U-694, U-731, U-1210, and U-1361 (Pomalyst) all appear across editions. The claimed method is the S.T.E.P.S. / RevAssist restricted-distribution workflow Celgene was required by FDA to run. This is not a paper patent.
• Primary line of business: branded biopharmaceuticals — discovery, development and marketing of drugs for cancer and inflammatory/immunologic disease (thalidomide/lenalidomide/pomalidomide franchise).
• Current status: operating, but no longer independent. Bristol-Myers Squibb completed its ~$74 billion cash-and-stock acquisition of Celgene on November 20, 2019; Celgene became a wholly owned BMS subsidiary. This was a merger, not a bankruptcy or a fire-sale. The patent expired ~11 months later.

Assignment timeline

Records found are the inventor→assignee chain only. No post-issuance assignment, security agreement, license recordation, or transfer to any third party was found.

• 2001-01-05 (executed) / recorded 2001-01-05 — Reel 11469/0882

  • Conveyance: Assignment (assignment of assignors' entire right, title and interest)
  • Assignor: Bruce A. Williams and Joseph K. Kaminski
  • Assignee: Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059
  • Correspondent: not stated in the sources I retrieved. (The Notice of Recordation is signed by "LaZena Martin, Examiner, Assignment Division, Office of Public Records" — that is the USPTO recording official, not the filing correspondent, and should not be recorded as such.)
  • Context: Original acquisition — inventors assign to the company that filed the application. Source: Celgene's own statement in Coalition for Affordable Drugs VI v. Celgene, IPR2015-01103, Paper 6 (Notice of Related Matters): "recorded with the United States Patent and Trademark Office on January 5, 2001, at Reel 11469, Frame 882." ⚠️ This reel/frame is recited for the parent '720 patent (Ser. No. 09/694,217); it is included here because it is the first link of the same inventor→Celgene chain, not because it is tied to 09/965,155.

• 2001-12-03 (recorded) — Reel/Frame not captured

  • Conveyance: Assignment (Google Patents legal events: "ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
  • Assignor: Kaminski, Joseph K.; Williams, Bruce A.
  • Assignee: Celgene Corporation
  • Correspondent: unknown (reel/frame not retrieved, so no correspondent field available)
  • Context: Original acquisition — this recordation date (Dec. 3, 2001) post-dates the Sept. 27, 2001 filing of 09/965,155 by ~9 weeks and is the record most likely covering the '977 application specifically. I could not retrieve its reel/frame, so treat the application-level attribution as probable, not confirmed.

• 2001-01-05 (instrument date) / recorded 2003-04-23 — Reel 013982/0697

  • Conveyance: Assignment ("ASSIGNMENT OF ASSIGNOR'S INTEREST")
  • Assignor: Williams, Bruce A.; Kaminski, Joseph K.
  • Assignee: Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059
  • Correspondent: not stated. No correspondent/attorney name appears on the Notice of Recordation as reproduced.
  • Context: Confirmatory re-recording for the continuation family. The USPTO Notice of Recordation in the exhibit carries the serial number 10/383,275 (filing date 03/07/2003) while the instrument body recites Ser. No. 09/694,217 — i.e., one instrument swept across the continuation chain. Later filings in the family point back to this record: the 2006 continuation (Ser. No. 11/437,551, later US 7,959,566) states "This continuation application is assigned of record to Celgene Corporation as evidenced by the assignment recorded on April 23, 2003 at Reel No. 013982 and Frame No. 0697." ⚠️ Flagged discrepancy: the instrument date on this record is 2001-01-05 — the same date as the Reel 11469/0882 link — while its recordation date is 2003-04-23. Either the same instrument was re-recorded, or two instruments share a date. I could not resolve this without the Assignment Center's own per-record view. Do not treat 11469/0882 and 013982/0697 as interchangeable; they are two distinct records.

Not found: any assignment from Celgene Corporation to Bristol-Myers Squibb recorded against this patent after the Nov. 20, 2019 merger. Merger transfers are frequently not individually recorded, so absence here is unremarkable and is not evidence of retained-separate ownership. Also not found: any assignment to an NPE, any security agreement, any license recordation.

Foreign-record aside (not a US assignment): the Serbian IP gazette (Glasnik 08/2024) shows the holder of Serbian registration 57253 changed to "CELGENE INTERNATIONAL II SÀRL, Rue des Pré-Jorat 14, 2108 Couvet, CH." That is a Serbian family-member record evidencing an intra-group reallocation to a Swiss Celgene entity. I found no corresponding US record for the '977 patent, and I am not treating the Serbian entry as evidence of a US assignment. Noted only so it isn't mistaken for one later.

Timeline diagram

timeline
    title Ownership of US 6561977
    2000 : Parent application 09694217 filed
    2001 : Inventors assign rights to Celgene Corp
         : Application 09965155 filed
         : Celgene assignment recorded Reel 11469 Frame 0882
    2003 : Patent US 6561977 issues
         : Celgene assignment recorded Reel 013982 Frame 0697
    2007 : First infringement suits filed by Celgene
    2019 : Celgene acquired by Bristol-Myers Squibb
    2020 : Patent expires

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. No transfer out of an operating assignee. The chain begins and ends at Celgene Corporation (Reel 11469/0882, Reel 013982/0697) and the patent expired still in the Celgene name. No "IP / Holdings / Ventures" successor, no registered-agent address, no single-member LLC appears anywhere in the record.

2. Known asserter in the chain — NOT PRESENT. Neither assignee — Celgene Corporation nor (via the Nov. 20, 2019 merger) Bristol-Myers Squibb — appears on any of the referenced NPE directories (Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation, Spangenberg entities). Both are NYSE/NASDAQ-listed operating pharmaceutical manufacturers. No Unified Patents / RPX high-frequency-plaintiff designation was found for either.

3. Repeat correspondent across the chain — UNCLEAR. This is an unresolvable signal on the present record, not a negative one: the chain has effectively one link (inventors → Celgene), so there is no "recurrence" to measure. The only name on the reproduced recordation notices is LaZena Martin, Examiner, Assignment Division, USPTO (Reel 013982/0697 facsimile), which is the recording official and must not be characterized as a correspondent of record. No attorney/agent correspondent is named on any record I retrieved, so I cannot run the recurrence test at all. If you need this signal resolved, pull the reel/frame images in Assignment Center — the correspondent lives on the cover sheet, which the court exhibit cropped.

4. Cascading transfers — NOT PRESENT. One conveyance type, one assignee, no chained LLCs, no sub-24-month sequence. The gap between the earliest and latest Celgene-related records is 2001 → 2003, and both run to the same operating company.

5. Pre-litigation transfer — NOT PRESENT. The relevant assignments (Reel 11469/0882 recorded 2001-01-05; Reel 013982/0697 recorded 2003-04-23) precede the first suit naming this patent by four to six years (the earliest D.N.J. actions are 2:07-cv-00286 and 2:07-cv-04050). There is no 6-month-before-suit assignment anywhere in the chain. The patent was held by its operating owner long before it was asserted.

6. Bankruptcy fire-sale — NOT PRESENT. Celgene's exit was the $74B BMS merger completed Nov. 20, 2019 — a premium acquisition, not a Chapter 7/11. No bankruptcy docket, no 363 sale, no debtor-in-possession transfer appears in the chain.

7. Privateering — NOT PRESENT. Celgene asserted the '977 patent in its own name against generic competitors in the Hatch-Waxman suits (e.g., 2:17-cv-06842 Lotus/Alvogen; 2:18-cv-00461 Apotex; 2:18-cv-06378 Dr. Reddy's; 2:18-cv-13477 Hikma/West-Ward, and Texas E.D. 2:18-cv-00461). Celgene is the plaintiff of record and the patent owner of record — the classic operating-company assertion posture, the opposite of privateering through a proxy.

8. Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at expiration on Oct. 23, 2020, still associated with Celgene/BMS.

Verdict

Operating-company assertion.

Celgene Corporation shipped THALOMID and REVLIMID embodying the claimed restricted-distribution method, held the '977 patent continuously from the inventors' assignment (Reel 11469/0882, and Reel 013982/0697 recorded 2003-04-23) with no recorded transfer to any third party, and asserted the patent in its own name against ANDA filers starting in 2007. The only equity event in the chain is the Nov. 20, 2019 Bristol-Myers Squibb merger — an operating-to-operating combination, not an NPE acquisition — after which the patent simply ran out its term on Oct. 23, 2020. There is not a single shell-entity, cascading-transfer, bankruptcy, privateering, or defensive-aggregator signal; the one signal I could not score (repeat correspondent) is unresolvable because the chain has only one link and the correspondent field was cropped from the record I retrieved, not because it was checked and came back clean.

Verification: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search "6561977" or application "09/965,155"); mirror index at https://assignment.uspto.gov/patent/index.html.

Two things to pull from the Assignment Center directly before relying on this for anything claim- or standing-determinative: (a) the reel/frame and full correspondent block for the record with recordation date 2001-12-03 (the likely application-specific assignment for 09/965,155); and (b) whether any 2019–2020 record exists transferring Celgene's US patent rights in the S.T.E.P.S. family to Bristol-Myers Squibb or Celgene International II Sàrl — my search did not surface one, but the merger-recording practice is inconsistent enough that "not found" here is a limitation, not a clearance.

I'll search for the cited prior-art references on the face of US 6,561,977, since the authoritative text I was given did not include the "References Cited" section.

Let me try to retrieve the front-page "References Cited" list directly from patent databases.

Important limitation up front

I was not able to retrieve the authoritative (56) "References Cited" list from the face of US 6,561,977 within this session's searches. The full text you supplied is the specification only — it ends mid‑sentence in the DETAILED DESCRIPTION and contains no "References Cited" block and no claims. My searches for the front‑page citation list (Google Patents, FreePatentsOnline, uspto.report, Justia) returned family, Orange Book, and "Cited By" data rather than the (56) list itself, and my search budget ran out before I could pull the patent PDF directly.

Because the operating rules require me to interpret identifiers literally and not fabricate citations, I will not invent a (56) list. Below I give (A) the prior‑art references I can verify are tied to '977 or its immediate family, with §102 analysis, and (B) an explicit statement of what remains unverified.

One identifier caution that matters for this task: US 6,561,976 (Elsayed et al.) and US 6,561,977 (Williams & Kaminski) are different patents one digit apart, in the same Celgene family. Do not conflate them.

A. References I can verify and analyze

1. US 6,045,501 — Elsayed et al. (the closest, applicant‑admitted prior art)

• Full citation: U.S. Patent No. 6,045,501, "Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug," Elsayed et al., assigned to Celgene Corp.
• Filing date: August 28, 1998 (Appl. No. 09/143,569). Issued: April 4, 2000.
• Why it is prior art to '977: '977 has a priority/filing basis of October 23, 2000 (continuation of 09/694,217, now US 6,315,720). '501 issued April 4, 2000, before that date → candidate reference under pre‑AIA §102(a) (patented before applicant's invention) and §102(e) (granted on an application filed Aug. 28, 1998, before applicant's invention). Note it is not a §102(b) statutory bar: April 4, 2000 is not more than one year before either the Oct. 23, 2000 priority date or the Sept. 27, 2001 filing date.
• Description / disclosure: Registering prescribers, pharmacies and patients in a computer‑readable medium; counseling; informed consent; and permitting access to the drug only after consulting the medium to verify the patient is either incapable of becoming pregnant or not currently pregnant (see the parallel claim 1 of the sibling '326 patent quoted in the O.G. record: "permitting said patient access to said drug only after consulting said medium to verify…").
• §102 relevance: '501 is cited by name in '977's own specification ("U.S. Pat. No. 6,045,501, to Elsayed et al., provides methods…"), so it is applicant‑admitted background art. However, it does not anticipate claim 1 of '977, because it does not disclose the claim‑1 limitations of (i) defining a plurality of patient risk groups, (ii) assigning the patient to a risk group and entering the assignment, and (iii) generating a retrievable "prescription approval code." '501 is therefore best characterized as a §103 obviousness reference against '977's claims, not a §102 anticipation reference. Where '977 has dependent claims reciting only prescriber/pharmacy/patient registration and informed consent, '501 is closer to anticipating those, but I have not verified the full dependent‑claim text and so will not assert this.

2. US 6,315,720 — Williams et al. (parent — family, not prior art)

• Citation: U.S. Patent No. 6,315,720, same title family; Appl. No. 09/694,217, filed Oct. 23, 2000; issued Nov. 13, 2001; inventors Williams & Kaminski.
• Status: This is the immediate parent of '977 (per '977's CROSS‑REFERENCE TO RELATED APPLICATION and per the '326 O.G. record). Under §102 it is not prior art to '977 — it is the same inventive chain by the same inventive entity. Important because the previous section of this analysis correctly noted that the Fed. Cir. affirmance in Celgene Corp. v. Peter (IPR2015‑01092 / CFAD VI) held unpatentable the claims of '501 and '720, not '977. Do not attribute that judgment to '977.

3. Family members that are NOT prior art (listed to prevent mislabeling)

US 6,561,976 (Elsayed), US 6,755,784 (Williams), US 6,869,399 (Williams), US 7,141,018 (Williams), US 7,959,566, US 8,315,886, US 8,626,531. Several of these appear in "Cited By" tables on other patents (e.g., Justia's US 11,584,748 and US 11,571,397 pages list '976/'977/'784/'399/'432 as Referenced Cited), but appearing in a later patent's citation list does not make them prior art to '977 — they are later/co‑owned family members. The later '784 claim 1 ("…has received an approval code… from a computer readable storage medium") differs literally from '977 claim 1 ("…has retrieved an approval code… from…"), consistent with the literal‑difference flag already raised.

4. Pre‑grant publication and non‑patent literature admitted in the specification

• US 2002/0052543 A1 — pre‑grant publication of '977 itself (published May 2, 2002). Self, not prior art.
• Applicant‑admitted NPL in the '977 Background: the Accutane (isotretinoin) pregnancy‑prevention program and the Slone Epidemiology Unit / Boston University survey. The specification states these were "developed in connection with Accutane" and reports ">325,000 women enrolled." This is admitted prior art and, if the underlying documents are dated more than one year before the relevant filing date, would be candidate §102(b) printed‑publication art. I have not verified the dates or bibliographic details of those documents and will not assert a §102 mapping without them. (Related family patents, e.g., US 8,589,188, cite a large Clozaril/clozapine‑program and Accutane NPL body — those are the kinds of printed publications that would be the real §102(b) candidates, but they belong to the '976/'188 chain and I have not verified they are on '977's face.)

B. What I could not verify (stated rather than guessed)

1. The exact (56) "U.S. Patent Documents" and "Other Publications" list on '977's face. I will not reconstruct it from memory. References I considered and did not confirm as being cited on '977 include US 5,183,597 (Lu) and US 5,726,219 (Baba), which I saw only in an international search report I could not positively tie to the '977/'720 family; and US 5,845,255 (Mayaud, "Prescription management system," issued Dec. 1, 1998), which appeared in a Google Patents link of ambiguous direction (cited‑by vs. cited). Treat all three as unconfirmed.
2. The full text of '977's dependent claims, which is necessary to map any reference to specific claims under §102. The previous section flagged that '977's claim 1 text came from a secondary aggregator (DrugPatentWatch) and that the total claim count is unconfirmed. §102 anticipation is claim‑element‑by‑claim‑element, so a precise anticipation mapping requires the printed claims.
3. Whether an IPR was separately instituted on '977. The known adverse family decisions are IPR2015‑01092 (US 6,045,501) and IPR2015‑01103 (US 6,315,720). I could not confirm an instituted IPR directed specifically at 6,561,977 or which references it used.

C. Recommended next step (to do this properly)

To produce the rigorous, citation‑by‑citation §102 mapping the task asks for, pull the authoritative (56) list from one of:

• USPTO PatentCenter full‑text for US 6,561,977 (front‑page "References Cited"),
• the patent PDF at patentimages.storage.googleapis.com (front page, item 56), or
• Google Patents → US6561977B2 → "Citations" / "Patent Citations" tab.

Once I have that list, each entry can be evaluated under pre‑AIA §102(a)/(b)/(e) against the (now‑confirmed) claim set. Based on everything I can verify, the single most relevant reference remains US 6,045,501 (Elsayed et al.), which is the prior art the '977 specification itself admits — and which, as the previous section correctly noted, is the very patent (together with '720) that Celgene Corp. v. Peter held unpatentable.

I'll gather the prior-art references associated with this patent before analyzing.

Let me check the specific references cited on the '977 patent's face and related third-party prior art.

Let me pin down the specific prior-art references and the IPR record on the sibling patents.

Obviousness Analysis — US 6,561,977 B2 under 35 U.S.C. § 103

Scope and sourcing caveat (read first)

What I could and could not verify. The authoritative full text supplied for this page is the specification only — it terminates mid-sentence in the "Detailed Description" and contains no claims and no "References Cited" / "Prior Art" listing. The Google Patents "Prior Art" tab content therefore was not in the provided text. I reconstructed the prior-art set from three sources, and I flag the provenance of each:

1. References named in the patent's own background (authoritative, from the supplied text): U.S. Pat. No. 6,045,501 to Elsayed et al. (the "Elsayed '501"), and the Accutane Pregnancy Prevention Program / Slone Epidemiology Unit survey (discussed in the background of the ⁄720 parent, which the ⁄977 shares).
2. The ⁄977 front-page "References Cited" list — I could not retrieve this directly. My searches returned the front pages of related family members, not the ⁄977 face. Do not treat the reference set below as a verbatim reproduction of the ⁄977 face.
3. The ⁄977/⁄720 litigation and IPR record, which identifies the prior art actually asserted against this family (United Healthcare Services v. Celgene, D. Minn. 0:20-cv-00686; the D.N.J. antitrust complaints; and the CFAD IPRs). These are pleadings/petitions, not adjudications binding on ⁄977, but they are the most complete catalogue of the art available and are highly probative.

Legal framework applied: ⁄977 has an effective priority date of October 23, 2000 (continuation of 09/694,217) and was filed September 27, 2001. It is therefore governed by pre-AIA § 103(a), and the Graham v. John Deere framework (scope/content of the prior art; differences; PHOSITA level; secondary considerations) governs.

Critical cross-reference flag (carried forward from the prior section): The Federal Circuit's affirmance in Celgene Corp. v. Peter held all claims of the '501 patent and claims 1–9 and 11–32 of the '720 patent unpatentable. That decision is not a ruling on ⁄977. I use it below only as strongly probative evidence of what a fact-finder found the disclosed art to teach, because ⁄977 is a continuation of the same 09/694,217 application and shares the ⁄720 specification nearly verbatim.

1. The claim to be tested

Reciting ⁄977 claim 1 (text carried forward from the prior section; sourced from a secondary aggregator, not yet confirmed against the printed patent):

"1. A method for delivering a drug to patients in need of the drug while restricting access to the drug by patients for whom the drug may be contraindicated, said method comprising permitting prescriptions for the drug to be filled by a pharmacy only after the pharmacy has retrieved an approval code for the prescription from a computer readable storage medium, wherein generation of the prescription approval code comprises the following steps: a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for the drug; b. defining a set of information to be obtained from a patient, which information is probative of the risk that an adverse side effect is likely to occur if the drug is taken by the patient; c. in response to the information set, assigning the patient to at least one of the risk groups and entering the patient, the information and the patient's risk group assignment in the medium; d. based upon the information and the risk group assignment, determining whether the risk that the adverse side effect is likely to occur is acceptable; and e. upon a determination that the risk is acceptable, generating the prescription approval code to be retrieved by the pharmacy before the prescription is filled."

Structural note that matters for § 103: Unlike the ⁄720 claim 1, which is drafted in Jepson format ("In a method … the improvement comprising"), the ⁄977 claim 1 as reported is not Jepson. This is a double-edged sword. It removes the "admitted prior art" preamble that eased the ⁄720's invalidity, but it also means the preamble ("prescriptions … filled only after the pharmacy has retrieved an approval code … from a computer readable storage medium") is a positive limitation that must be affirmatively taught. That limitation is the analytic crux, and it is the one the Examiner found absent from Elsayed during the ⁄720 prosecution ("Elsayed … does not teach a step of generating of a prescription number or code, which can be retrieved by a pharmacy before said prescription is filled"). Everything therefore turns on the secondary references.

2. Prior-art reference set

A note on § 103(c) (pre-AIA). Several of these references (Elsayed '501, the Thalomid PI, Zeldis) are Celgene-owned/common to the inventors. Under pre-AIA § 103(c)(1), art that qualifies only under § 102(e), (f), or (g) and is commonly owned is disqualified for § 103. Elsayed '501 and the Thalomid PI, however, also qualify under § 102(a)/(b) (publicly patented/published more than one year or at all before the invention), so § 103(c) does not exclude them. I flag this because the point is contested and I have not independently confirmed each reference's § 102(f)/(g) status.

3. Element-by-element mapping (claim 1)

Net: no single reference teaches all of (a)–(e) plus the retrieving preamble. But every element is taught, and the combination is the classic § 103 case.

4. Grounds of obviousness

Ground A — Elsayed '501 (or July 1998 Thalomid PI / S.T.E.P.S.) + Dishman (CPMS) + Boyer or Cunningham

Rationale / motivation to combine. This is the strongest ground, and its motivation is express in the prior art itself:

• At the September 4–5, 1997 CDER meeting, Celgene's own Bruce A. Williams — a named ⁄977 inventor — explained that the Clozaril and Accutane procedures were a "starting point" in developing thalidomide distribution procedures (pleaded and quoted in the D.N.J. antitrust complaints).
• At the March 26, 1997 CDC meeting, Celgene personnel discussed exactly the ⁄977 elements: patient/pharmacy/prescriber registration; counseling on teratogenicity and contraception; required pre-therapy pregnancy testing; monthly testing thereafter.
• FDA approved Thalomid under 21 CFR § 314.520 (Subpart H) relying on the isotretinoin/clozapine precedent — the Office of the reviewer (FDA) itself treated the combination as predictable, a KSR "design incentive" fact.

Why a PHOSITA would combine. All three references are in the same field (controlled distribution of drugs with life-threatening/teratogenic adverse effects), address the same problem (preventing a contraindicated individual from receiving the drug), and disclose complementary, non-overlapping mechanisms: Elsayed supplies the registration/counseling/pregnancy-test architecture; Dishman supplies the risk-threshold lock-out; Boyer/Cunningham supply the machine-generated approval code at the pharmacy interface. There is a finite number of identified, predictable solutions, and the combination yields no more than the expected result — the "predictable variation" branch of KSR.

Ground B — Mitchell (Accutane PPP) + Honigfeld I/II & The Guide (CPMS) + Boyer/Cunningham

This is the ground the Board actually instituted and sustained against the ⁄720 (IPR2015-01102/-01103: Powell/Mitchell + Dishman, in view of Cunningham). Because ⁄977 shares the ⁄720 specification, the Board's findings translate almost mechanically to ⁄977 claim 1: Mitchell teaches the risk-qualification/survey elements (a)–(b); CPMS/Dishman teach registry gating and the acceptability determination (c)–(d); Cunningham/Boyer teach code generation/retrieval (e). The Board held claims 1–9 and 11–32 of the ⁄720 unpatentable on essentially this record; claim 1 of ⁄977 recites the same affirmative risk-acceptability + code-generation sequence.

Ground C — Zeldis (S.T.E.P.S., Feb. 1999) alone or + Boyer/Cunningham

The Zeldis article is expressly pleaded as § 102(b) art against ⁄977 (and against '720, '784, '886) — i.e., the plaintiffs assert it predates ⁄977's priority by more than a year. Zeldis discloses the full S.T.E.P.S. program: registration of prescribers/pharmacies/patients, counseling, pregnancy testing, monthly surveys. Combined with Boyer/Cunningham for the code-generation/retrieval step, this yields all of claim 1. (Note: the plaintiffs concede Zeldis is not art against '501/'976 because of their earlier dates — a precisely-drawn distinction that reinforces its availability against ⁄977.)

Ground D — Secondary/dependent-claim references

• Mann & Lutwak-Mann supports the male-counseling / condom limitations (⁆977 dependent claims on male patient behavior).
• Mundt supports the IVR survey dependent claim (parallel to ⁄720 claim 17, which CFAD argued via Mundt).
• Repeated prosecution reliance on Boyer by the Examiner against the ⁄720 claims shows the Office treated code-generation as within the art.

5. Motivation-to-combine synthesis (the § 103 "why")

Four independent motivations, each articulated in the record:

1. Express prior-art teaching to combine — Williams/Celgene stating Clozaril + Accutane were the "starting point." This is the strongest possible motivation evidence: it comes from the inventors themselves.
2. Same field / same problem — registry-gated distribution of drugs whose adverse effects are catastrophic; the art is unitary.
3. Regulatory pressure / design incentive — FDA Subpart H conditioning; the well-documented demand (public and congressional) that thalidomide not be distributed without restriction. KSR market/regulatory pressure.
4. Predictability + finite solutions — the FDA approved Thalomid because the isotretinoin/clozapine model was believed to work (petitioner's oral-hearing argument in IPR2015-01103). Predictable result from known elements.

Reasonable expectation of success is supported because the combination does no more than arrange known process steps (register → test → gate → code → dispense) in a known order for their known purposes.

6. Where ⁄977 may nevertheless be non-obvious (honest counterweight)

I should not overstate. Three real counterarguments:

(i) The Boyer rejection was overcome in the ⁄720 prosecution — but only on a distinction that ⁄977 may not share, or may share. Celgene's inventors argued Boyer's code was "merely associated with every prescription," whereas the claimed code required "an affirmative decision" and was generated only if risk was acceptable — and the Examiner allowed. That argument is strong against a bare Boyer-based rejection. But it is weak against a Dishman + Boyer combination (Dishman supplies the conditional lock-out) and it failed at the PTAB on the ⁄720's covered claims. Verdict: the "affirmative decision" argument does not save ⁄977 claim 1 on a properly constructed combination, but it is the argument to expect from the patentee.

(ii) The Board upheld ⁄720 claim 10 (genetic testing) as not obvious. The Board, on rehearing, found the ⁄720 claim reciting genetic testing was not proven obvious because the record lacked support that genetic testing was a known diagnostic in this context. If ⁄977 contains a dependent claim to genetic testing (its specification discusses it, and my prior section noted claim 9 recites diagnostic-testing results), that dependent claim may be non-obvious for the same reason, on the same evidentiary gap. By contrast, pregnancy-testing and WBC-testing dependent claims are squarely met by the art.

(iii) Objective indicia / secondary considerations. Celgene has advanced: near-total success preventing thalidomide birth defects; FDA reliance; industry copying; and "unexpected" program success. The PTAB and the Federal Circuit rejected these (finding the results predictable and the evidence self-interested / contradicted by reported fetal exposures). But the ⁆977 record is not the ⁄720 record, and an analysis must be done afresh for ⁄977 — the nexus between the ⁄977 claims specifically and the asserted success, and the fact that the claimed method is arguably a business/administrative method, are proper subjects for argument.

"Teaching away" caution: Celgene argued that the clozapine system taught away from this approach because it was "unsuccessful" (382 agranulocytosis cases, 12 deaths). The Board did not accept this as a teaching-away sufficient to overcome. I do not think teaching-away carries the day here.

7. Bottom line

• ⁆977 claim 1 is very likely obvious over the combination of Elsayed '501 (or the July 1998 Thalomid PI/S.T.E.P.S.) + CPMS/Dishman + Boyer (or Cunningham), with Mitchell and Zeldis supplying the risk-group/survey elements. Motivation is evidenced in the prior art itself by the inventor's own "starting point" statement and by FDA's reliance on the Accutane/Clozaril precedent.
• The strongest single ground is the one the Board sustained against the ⁄720 (Mitchell/Powell + Dishman + Cunningham), because the ⁆977 and ⁄720 specifications are shared and claim 1's affirmative risk-acceptability + code-generation sequence is materially identical.
• Claims most likely to survive are those reciting genetic testing (and possibly narrow diagnostic modalities) for the reasons in § 6(ii).
• My confidence is moderate-to-high on claim 1, low on the full claim set, because (a) I could not retrieve the ⁆977 claim text from the primary source, and (b) I could not confirm whether ⁆977 has further independent claims beyond claim 1 (the ⁆720 has two independent claims, 1 and 28) — the "second independent claim" question flagged in the prior section remains open and could change the analysis.

Explicit uncertainty flags

1. The ⁆977 "References Cited" face list was not retrieved; the reference set above is reconstructed from the ⁄720/⁄977 family's litigation and IPR record. Verify against the printed patent or PatentCenter before relying on any single citation.
2. The ⁆977 claim text (claim 1 and all other claims) is sourced from a secondary aggregator; the primary text is unconfirmed.
3. The total claim count and existence of a second independent claim in ⁆977 are unconfirmed.
4. The Federal Circuit/PTAB holdings cited apply to the '501 and '720 patents, not ⁆977; I use them as evidence of what the shared disclosure/art teaches, not as a legal determination about ⁆977.
5. § 103(c) common-ownership treatment for the Celgene-owned references is flagged but not independently resolved.