US 6561976

I'll verify the patent details against live sources, including any litigation/docket activity.

Let me check specifically for any 2026 CAFC activity and PTAB challenges involving this patent.

US Patent 6,561,976 — Verified Summary

Verification status: Details below are grounded in the Google Patents full text (fetched 2026‑10‑01), an FDA Orange Book listing, the USPTO Official Gazette entry for the related '326 patent, and litigation records. Where sources conflict, I flag it.

Abstract (as issued): "Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug."

Independent claims in plain language

The patent has 16 claims; claims 1, 8, and 15 are the independent ones. All three are method claims directed to a controlled drug-distribution/risk-management workflow (in practice the thalidomide S.T.E.P.S.-type program).

Claim 1 — "Database-verified access" method (teratogenic drug, either sex):

1. Register, in a computer-readable storage medium, physicians permitted to prescribe the drug.
2. Give the patient counseling information about the teratogenic risks to a fetus.
3. Obtain the patient's informed consent to take the drug despite those risks.
4. Register the patient in the medium, including whether the patient can become pregnant or can impregnate a female.
5. If the patient can become pregnant, determine she is not currently pregnant and register that fact.
6. Allow access to the drug only after consulting the medium to verify the patient is either incapable of becoming pregnant or not currently pregnant.

• Dependent claims add: the drug is thalidomide (2); access via prescription (3); ≤~28-day supply (4); re-screening/pregnancy test before refill (5); contraception counseling (6); providing a contraceptive device/formulation (7).

Claim 8 — the same method without the database-consultation step:
Identical to claim 1 in steps (a)–(e), but step (f) requires permitting access "only after verifying that said patient is either incapable of becoming pregnant or is not currently pregnant" — i.e., verification generally, without the express "consulting said medium" limitation. Its dependents (9–14) mirror claim 1's dependents.

Claim 15 — pharmacy-eligibility method (female patient):
Authorize pharmacies to fill prescriptions for the drug only after confirming the patient's eligibility, register authorized prescribing physicians in a computer-readable storage medium, and register the patient in that medium. The patient is "deemed eligible" only if all four criteria are met:

1. counseled on the danger of fetal exposure and gave informed consent;
2. counseled to use at least two forms of birth control for at least ~4 weeks before starting treatment and throughout treatment;
3. tested negative for pregnancy for the month before and for each month during treatment; and
4. the prescription is for no more than ~28 days' supply and was written no more than ~7 days before being presented for fulfillment.

• Dependent claim 16: the teratogenic drug comprises thalidomide.

The specification adds non-claimed context: pharmacy registration, ≤28-day prescriptions with no refills, patient surveys (monthly for women, quarterly for men), prescriber reminders at ~14–21 days, and a stated "avoidance rate" of fetal exposure above ~50% (up to ~100% in preferred embodiments).

Litigation / USPTO activity (with uncertainty flagged)

• District court (D.N.J.): The NPE Litigation Database and Google Patents family/litigation links show cases involving the '976 patent, including Celgene v. Natco Pharma (2:12‑cv‑04571; 2:14‑cv‑03126), Celgene v. Barr Laboratories (2:07‑cv‑00286, and related 2:07‑cv‑04050, 2:07‑cv‑05485), plus 2:10‑cv‑05197 and 2:15‑cv‑00697.
• PTAB/IPR: I found IPR challenges (Coalition for Affordable Drugs VI, IPR2015‑01103 et al.) directed at US 6,045,501 and 6,315,720 — not directly at the '976 patent. I did not find an IPR naming the '976 patent as the challenged patent.
• Antitrust follow-on: In In re Revlimid and Thalomid Purchaser Antitrust Litigation (D.N.J.), plaintiffs alleged Walker Process fraud / inequitable conduct as to the "REMS patents," expressly listing the '976 patent; the court's opinion noted the Thalomid-related patents ('399, '018, '566) were not pursued by the insurer plaintiffs.
• CAFC 2026: ⚠️ I could not find any Court of Appeals for the Federal Circuit 2026 docket or appeal involving US 6,561,976. Searches returned no 2026 CAFC activity. Given the patent expired Aug. 28, 2018, a 2026 appeal directly on this patent would be unusual. I cannot confirm CAFC 2026 activity exists, and I do not have authoritative docket data beyond what is above.
• The Celgene appeals to the Federal Circuit that I did find (filed Nov. 2017) concerned the PTAB's invalidation of the '501 and '720 patents, not the '976 patent.

Uncertainty summary: the filing-date discrepancy (Sept. 26 vs. Sept. 6, 2001); and the absence of any confirmed 2026 CAFC docket for this number. Everything else above is directly grounded in the sources cited.

I'll research litigation involving US Patent 6,561,976. Let me run several targeted searches.

Let me dig into the specific case numbers and the Stanford NPE database entries.

Litigation Involving U.S. Patent 6,561,976

Bottom line: Yes — litigation is known. US 6,561,976 ("Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug," Celgene Corp., expired Aug. 28, 2018) was asserted by Celgene in a series of ANDA/Hatch‑Waxman patent infringement suits in the District of New Jersey, all arising from generic challenges to THALOMID® (thalidomide) and REVLIMID® (lenalidomide). All identified suits were resolved by settlement, not by judgment. Below I separate what is directly confirmed from what is listed but for which I could not fully verify party details.

Confirmed assertions

Listed on the patent record but details not independently verified

• Celgene Corporation v. [party], 2:07-cv-05485 (D.N.J., 2007) — flagged on the Google Patents litigation panel for this patent; I could not confirm the named defendant(s) or disposition within my search budget. This is almost certainly another THALOMID®/thalidomide ANDA suit from Celgene's 2007 wave of distribution‑method‑patent litigation.
• Celgene Corporation v. [party], 2:07-cv-04050 (D.N.J., 2007) — same caveat.

Related IPR proceedings (Patent Trial & Appeal Board)

• Coalition for Affordable Drugs VI LLC v. Celgene Corporation, IPR2015‑01092, ‑01096, ‑01102, ‑01103, and ‑01169 (filed April–May 2015). These IPRs challenged Celgene's REMS/distribution‑method patents. Exhibits in these proceedings include the THALOMID Orange Book listing that contains the ’976 patent, but I could not confirm that any of these IPRs specifically instituted review of the ’976 patent (IPR2015‑01103, for example, is captioned to U.S. Pat. 6,315,720). Treat the ’976‑specific IPR connection as unconfirmed.

Notes and caveats

• Jurisdiction: Every identified case was filed in the U.S. District Court for the District of New Jersey (D.N.J.). I found no ITC, Federal Circuit merits appeal, or foreign litigation specifically on the ’976 patent.
• Antitrust follow‑on suits are not ’976 infringement actions. Cases such as In re Thalomid and Revlimid Antitrust Litigation (D.N.J. 2:14-cv-06997), Cigna v. Celgene (E.D. Pa. 2:21-cv-00090; S.D.N.Y. 1:25-cv-05237), and the Pomalyst pay‑for‑delay class actions reference Celgene's "distribution method patents," the Orange Book listing of the ’976 patent, and alleged sham litigation — but the ’976 patent is not the asserted claim in those antitrust matters. I mention them so they aren't confused with the infringement suits above.
• Do not conflate with sibling patents. Celgene's related REMS/distribution patents include US 6,045,501; 6,315,720; 6,561,977; 6,755,784; 6,867, 399; 6,908,432; 7,141,018; 7,959,566; 8,204,763; 8,315,886; 8,626,531; and 8,589,188. Several very similar cases (e.g., Celgene v. Hikma Pharmaceuticals Int'l, D.N.J. 2:18-cv-13477) assert those patents but, based on the dockets reviewed, did not assert US 6,561,976 — so they are excluded here.
• Date basis: The ’976 patent expired Aug. 28, 2018, so no active infringement litigation on it is expected as of April 2026.
• I was unable to complete additional confirmation searches (tool-step limit reached); the two 2007 docket numbers above and the exact ’976 IPR question should be verified directly on PACER/CourtListener and the PTAB docket before being relied upon.

Primary sources consulted:

• Stanford NPE Litigation Database – patent 6561976: https://npe.law.stanford.edu/patent/6561976
• Google Patents litigation panel for US 6,561,976: https://patents.google.com/patent/US6561976/en
• CourtListener, Celgene v. Natco Pharma Ltd., 2:10-cv-05197 (stipulation naming the ’976 patent): https://www.courtlistener.com/docket/[4310166](/patent/4310166)/
• Patexia / DrugPatentWatch docket summaries for 2:10-cv-05197, 2:12-cv-04571, 2:15-cv-00697
• CFAD VI v. Celgene IPR exhibits (IPR2015-01103 / -01096): https://www.bigmoleculewatch.com/wp-content/uploads/sites/2/2015/09/IPR2015-01103.pdf

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

The structured block says no AIA proceedings, but I saw a PTAB reference to CFAD v. Celgene. Let me pin down whether any petition actually targeted 6561976.

The CFAD IPRs targeted the '501 and '720 patents — not the '976. Let me confirm whether any petition ever named 6,561,976.

PTAB Proceedings — US 6,561,976 ("Methods for delivering a drug to a patient while preventing the exposure of a foetus...")

Canonical source note: The structured "PTAB proceedings on file" block supplied in this prompt states that the USPTO Open Data Portal returns no AIA trial proceedings for this patent. My independent web checks (PTAB docket aggregators, Celgene's SEC disclosures, Orange Book litigation trackers, and the In re Revlimid and Thalomid Purchaser Antitrust Litigation record) are consistent with that and surfaced no IPR, PGR, or CBM petition ever naming 6,561,976. I found no proceeding number to report, and I will not invent one.

Proceedings overview

Total AIA trial proceedings on US 6,561,976: zero (0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 institution denials). The patent has never been tested at the PTAB. Critically, that is not the same as "the patent is hardened" — it is untested and un-adjudicated, and the closest sibling patents in the same Elsayed family ('501 and '720) were invalidated as obvious in 2016 and affirmed on appeal in 2019. The defensive posture is therefore: no PTAB estoppel binds anyone as to the '976, but the same prior art that killed its siblings is fully available against it. Separately, the '976's term ended on 2018-08-28 (listed as "Anticipated expiration"; Google Patents/ODP status "Expired - Lifetime"), so any current assertion is a past-damages-only claim subject to the 35 U.S.C. § 286 six-year lookback.

For each proceeding

There are no proceedings to itemize. Listing nothing is the accurate result. Below, I summarize the adjacent proceedings that matter to this patent, clearly flagged as not being proceedings against the '976.

ADJACENT (NOT ON THE '976') — Coalition for Affordable Drugs VI LLC v. Celgene Corporation

• Proceeding numbers: IPR2015-01092, IPR2015-01096, IPR2015-01102, IPR2015-01103 (four petitions)
• Patents actually challenged: U.S. 6,045,501 (the '501) and U.S. 6,315,720 (the '720). Neither is 6,561,976. The '976 appears in this record only as an exhibit (Orange Book listing, Ex. 1046/1048; patent family tree, Ex. 2049) and as background in the expert deposition of Dr. Jeffrey Fudin — never as a challenged patent. Docket Alarm confirms IPR2015-01103 is captioned "Inter Partes Review of U.S. Pat. 6,315,720."
• Type: Inter Partes Review.
• Filed: 2015-04-23 (per Docket Alarm docket header).
• Status: Terminated. FWD issued 2016-10-26.
• Judge panel (IPR2015-01103, per Docket Alarm): Grace Karaffa Obermann, Jaqueline Wright Bonilla, Michael Kim, Michael Tierney, Tina Hulse, Toni Scheiner.
• Petition grounds: § 103 obviousness, principally over the Powell, Mitchell, and Dishman references (as characterized in the later D.Ν.J. antitrust opinion), with Cunningham also relied upon.
• Institution decision: Instituted 2015-10-27 (per Celgene's 10-K disclosures).
• Final Written Decision: 2016-10-26 — the Board held the '501 and '720 claims unpatentable as obvious. Per the D.N.J. antitrust opinion, "the PTAB found the '501 Patent invalid as obvious over the Powell Reference, the Mitchell Reference, and the Dishman Reference," and the '720 "was obvious over the same three references, as well as one additional prior art" reference.
• Settlement / termination: No settlement — these went to FWD.
• Appeal: Celgene requested rehearing on 2016-11-25; the Board denied rehearing as to the '501 on 2017-09-08 but granted rehearing as to a certain claim of the '720. Celgene appealed (notices 2017-11-06 for the '720, 2017-11-09 for the '501). The Federal Circuit affirmed: Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) — "We therefore affirm the Board's determination that claims 1–9 and 11–32 of the '720 patent are unpatentable as obvious over the asserted prior art." (Exact 2019 decision date not independently verified here.)
• Why it matters to the '976: Same specification family. The '976 is a continuation in the Elsayed chain (09/143,569 → '501; 09/479,682 → 09/964,068 → '976), so the Powell/Mitchell/Dishman/Cunningham obviousness rationale is directly transferable. It is not, however, binding on the '976 — different claims, different record, no estoppel, no res judicata.
• Links: FWD — https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2015-01103/Inter_Partes_Review_of_U.S._Pat._6315720/10-26-2016-Board/Final_Decision-76-Final_Written_Decision/ ; CAFC — https://app.midpage.ai/document/celgene-corporation-v-peter-[4421131](/patent/4421131) ; antitrust context — http://business.cch.com/ald/InreRevlimidandThalomidPurchaserAntitrustLitigation672024.pdf

Strategic summary

Claim status. Every one of the '976's 16 claims (1–16) is UNTESTED at the PTAB — none canceled, none sustained, none disclaimed by the Board. Do not let anyone tell you the '976 has "survived IPRs"; it has never faced one. What has happened is that its two closest siblings were wiped out as obvious: the '501 and '720 were invalidated on 2016-10-26 and that holding was affirmed in Celgene v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). Because the '976 shares the Elsayed specification and closely tracks the '501's and '720's subject matter (registration of prescribers/pharmacies/patients, counseling, informed consent, pregnancy screening, controlled dispensing), the same prior art is the natural § 103 attack. Note the patent expired 2018-08-28, so the '976 is now a past-damages-only asset.

Estoppel landscape. 35 U.S.C. § 315(e)(2) estoppel attaches only to petitioners, real parties in interest, and privies who were parties to an IPR on that patent. Because no IPR was ever filed on the '976, no § 315(e)(2) estoppel exists as to the '976 — not against CFAD, not against anyone. A defendant today may raise any § 102/§ 103 ground, including the Powell/Mitchell/Dishman/Cunningham combination, in district court. The only timing constraint is the ordinary one: if you are served with an infringement complaint, § 315(b) gives you one year to petition. Also keep in mind the Celgene v. Peter affirmance is persuasive authority a court can consider even though the '976 claims were not adjudicated.

Pattern signals. Celgene/CFAD litigation was a hedge-fund-funded, multi-patent campaign (CFAD VI filed four petitions covering two patents in one day), and Celgene litigated the resulting appeals aggressively through the Federal Circuit. Notably, no defensive aggregator (Unified Patents, RPX, etc.) ever petitioned on the '976 — the file's only litigation entries for '976 are district court matters: Celgene v. Natco (D.N.J. 2:12-cv-04571, 2:14-cv-03126), the Lannett ANDA case (D.N.J., filed 2015-01-30, settled 2017-10-24 with a license beginning 2019-08-01), and the Revlimid/Thalomid antitrust MDL (D.N.J.), where plaintiffs alleged the '976 was procured by Walker Process fraud/inequitable conduct because it is "nearly identical" to the fraudulently obtained '501 and '720.

Recommended next steps

• No claims of the '976 have been invalidated, so there is no FWD to quote as a knockout. The usable ammunition is the '501/'720 FWD (2016-10-26, IPR2015-01103 and siblings) and its Federal Circuit affirmance, Celgene v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). Quote the CAFC's disposition verbatim in any invalidity contention: "We therefore affirm the Board's determination that claims 1–9 and 11–32 of the '720 patent are unpatentable as obvious over the asserted prior art." Frame it as compelling persuasive authority applying the identical prior art to the same specification family — not as binding on the '976.
• Watch the clock, not the docket. There are no active proceedings, so no institution deadline, no oral hearing, and no FWD due date to track. The live date that matters is 2018-08-28 (expiration) and the § 286 six-year damages lookback.
• An IPR on the '976 now is likely a poor investment — the patent is expired, so there is no injunction to defeat and the Board may be disinclined to institute absent a concrete past-damages controversy. If you are defending a damages demand, the better path is (i) § 282 invalidity based on the Powell/Mitchell/Dishman/Cunningham art, and (ii) an unenforceability/inequitable conduct theory built on the same Accutane/Clozaril prior art that plaintiffs in the D.N.J. antitrust MDL allege Celgene withheld — an allegation the FWD record partially corroborates ("the PTAB noted that ... Celgene freely admitted that its plan for the safe distribution of its drugs was based on experience with restrictions on other drugs with severe adverse effects such as Accutane and Clozaril").
• Say it plainly in any opinion you write: there is no PTAB activity on US 6,561,976. The absence is real and verified, but it is not a sign of strength here — it reflects that the '976's near-identical siblings absorbed the invalidity fire, and that the '976 expired before the REMS-patent challenge wave crested.

Confidence / caveats: I am highly confident that no AIA trial named 6,561,976, based on the ODP default plus multiple independent docket and disclosure checks. I did not independently verify the exact 2019 issuance date of Celgene v. Peter, 931 F.3d 1342, nor the precise claim-level mapping of the four CFAD IPRs to their two target patents; treat those specifics as to be confirmed against the PTAB E2E docket (https://ptacts.uspto.gov/) and the CAFC opinion before filing.

I'll research the recorded assignment history for US 6,561,976, starting with the USPTO Assignment Center and cross-references.

Let me pull the uspto.report record and attempt to surface assignment/reel-frame data directly.

Good — I have the Google Patents legal event (reel 9548/0670). Let me verify whether any post-issuance assignment exists (e.g., Celgene → BMS, or a security interest).

I attempted live lookups, but the USPTO Assignment Center is a JavaScript application that my search tooling cannot query directly, so I could only retrieve assignment data as mirrored in Google Patents legal events and third-party indexes. I flag that limitation below rather than filling the gaps with inference. (My search budget for this session is now exhausted.)

Inventors

Both men are listed as assignors on the recorded assignment (reel 009548 / frame 0670, below), assigning to Celgene Corporation. That is strong circumstantial evidence they were Celgene employees or under an obligation to assign at filing, but I do not have a payroll/employment record confirming it.

Unusual-pattern check: No evidence of inventors departing the assignee within 12 months of filing. I found no employment-history data establishing departures at all, so this is not assessable rather than "clean." No inventor is separately named as a competitor or later assignee.

Note: a 2018 Celgene complaint (D.N.J. 2:18‑cv‑13477) prints "Bruce A. Williams, Flemington, NJ" as an inventor on a different patent in the family (with Joseph K. Kaminski), which corroborates Williams' continuing role at Celgene but does not add assignment information for the '976 patent.

Original assignee

Celgene Corporation — named on the face of the issued patent (Warren, NJ at issue; the corporate address later moved to Summit, NJ). Confirmed by USPTO Official Gazette text for the related '326 continuation ("Assigned to Celgene Corporation, Warren, N.J. (US)").

• Line of business: research-based pharmaceutical company (immunomodulatory drugs).
• Product embodying the claims: Yes. The claims are a drug-distribution risk-management workflow. Celgene shipped THALOMID (thalidomide), approved 1998 for ENL and dispensed through the S.T.E.P.S. program, and later REVLIMID (lenalidomide) / RevAssist and POMALYST / Pomalyst REMS. The '976 patent is listed in the FDA Orange Book against NDA 020785 (Thalomid), NDA 021880 (Revlimid) and NDA 204026 (Pomalyst), all expiring 2018‑08‑28.
• Current status: Celgene was acquired by Bristol‑Myers Squibb (deal completed late 2019) and operates as a BMS subsidiary. ⚠️ This is from general knowledge, not from a source retrieved in this session, and — importantly — I found no recorded assignment on this patent reflecting that merger, nor any change-of-name or merger recording at all. Treat the corporate acquisition as context, not as a documented assignment link.

Assignment timeline

⚠️ Sourcing caveat: I could not query assignmentcenter.uspto.gov directly. The entries below come from Google Patents legal events (which mirror the underlying USPTO assignment records) plus the patent full text. The correspondent of record was not retrievable for any link, so I cannot name it without fabricating — I have left it marked unavailable.

• Executed: not stated / recorded 1998‑10‑26 — Reel 009548 / 0670
  • Conveyance: Assignment
  • Assignor: Marc Elsayed; Bruce Williams
  • Assignee: Celgene Corporation
  • Correspondent: ⚠️ Unavailable — could not be retrieved. (Recording‑date note in the record itself: "CROSS-REFERENCE OF ASSIGNMENT FILED IN UNITED STATES APPLICATION NO. 143,569 RECORDED ON OCTOBER 26, 1998 AT REEL NO. 9548 AND FRAME NO. 0670.") Because only one link exists in this chain, the "repeat correspondent" test cannot be run at all.
  • Context: original employment/prosecution assignment. It was originally filed against the priority application 09/143,569 (issued as US 6,045,501) and Google Patents surfaces it on the '976 record as a cross‑reference legal event dated 2003‑04‑14. The 2003‑04‑14 date is when the cross‑reference appears in the legal‑events feed, not the recording date.

No other recorded assignments. Google Patents shows no post‑issuance reassignment, security agreement, license, change‑of‑name, or merger entry for this patent through its 2018‑08‑28 expiration. I also could not locate a separate recorded assignment keyed to application 09/964,068 itself; the only assignment associated with the file is the 1998 parent‑application recording above. If the Assignment Center shows additional entries, they were not surfaced by the sources I could reach.

Cross-reference resolution: the previously flagged filing-date discrepancy for 09/964,068 (Sep. 26 vs. Sep. 6, 2001) is resolved in favor of 2001‑09‑26 — the Celgene family-tree exhibit filed in IPR2015‑01103 (Celgene Exhibit 2049) states "U.S. Patent No. 6,561,976 / Application No. 09/964,068 … 09/26/2001," matching Google Patents. The "Sep. 06, 2001" in the '326 Official Gazette entry appears to be a typographical error.

Timeline diagram

timeline
    title Ownership of US 6561976
    1998 : Priority application filed by Celgene
         : Assignment recorded reel 009548 frame 0670
    2001 : Continuation filed as 09/964068
    2003 : Patent issued 13 May
    2007 : First Celgene infringement suits filed
    2012 : Celgene v Natco filed D N J
    2018 : Patent expired 28 August
    2019 : Celgene acquired by BMS not recorded here

NPE / troll-pattern signals

Litigation context (builds on the prior section): the '976 patent is one of the fourteen "REMS patents" pleaded in the Thalomid/Revlimid antitrust complaints (see the Walker Process / inequitable conduct allegations at D.N.J. 2:21‑cv‑20451 and 3:23‑cv‑05144). That is an operating company asserting a distribution-method patent against generic ANDA filers, with antitrust counterclaims — the opposite of an NPE posture.

Verdict

Operating-company assertion.

Justification: the chain consists of a single recorded assignment (reel 009548 / frame 0670, recorded 1998‑10‑26) from inventors Elsayed and Williams to Celgene Corporation, with no subsequent shell transfer, no known NPE, no cascading LLC chain, and no correspondent recurrence to test. Celgene is a product company that shipped Thalomid/Revlimid/Pomalyst embodying the claims and asserted the patent in its own name against actual generic competitors (Celgene v. Natco, D.N.J. 2:12‑cv‑04571 and 2:14‑cv‑03126; Stanford NPE database classifies the asserter as "Product company"). Caveat: the patent expired 2018‑08‑28, so there is no live assertion today, and I was unable to retrieve the assignment correspondent or to confirm any recording of the later Celgene→BMS acquisition.

Verify: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search patent number 6561976; also indexed at https://assignment.uspto.gov/patent/index.html). Cross-check the litigation record at https://npe.law.stanford.edu/patent/6561976 and the Orange Book listing for NDA 020785.

I'll verify the patent against live sources and research each cited reference. Let me run several searches in parallel.

Let me verify the remaining cited references and confirm the USPTO record for the patent.

Prior-Art Analysis — US 6,561,976 B2

Note on sources / verification. I searched for the specific number 6561976 and relied on the authoritative full text supplied (Google Patents, fetched 2026‑10‑01) for the citation list. The bibliographic record matches the previously generated summary: US 6,561,976 B2, application 09/964,068, filed 2001‑09‑26 (⚠️ the USPTO Official Gazette entry for the '326 continuation states "Sep. 06, 2001" — the previously flagged discrepancy stands and is not resolved here), priority 1998‑08‑28, granted 2003‑05‑13, Celgene Corporation, inventors Elsayed & Williams. I did not auto‑correct any identifier.

I could not retrieve every cited reference's full text within the tool‑call budget; where a description is drawn from the reference's own title/abstract rather than verified full text, I say so.

Two structural cautions that govern everything below:

1. Not every item on the face of the '976 is statutory prior art. The '976's effective critical date is 1998‑08‑28 (priority) / 2001‑09‑26 (actual filing). Several "Patent Citations" post‑date 1998‑08‑28 and therefore are not available as §102(a)/(b) art. They are on the page as related‑/informational citations.
2. The '976 is a pre‑AIA patent (effective filing 1998/2001), so §§102(a), (b) and (e) as they read pre‑2013 apply. Because all three independent claims (1, 8, 15) require a teratogenic‑drug‑specific, fetal‑exposure‑prevention, pregnancy‑status‑verification workflow, no cited reference that is merely a generic medical‑informatics or prescription‑management system can anticipate them.

A. The 17 "Patent Citations" of record on US 6,561,976

Listed in the order printed on the patent. "Potentially anticipates" gives my §102 assessment.

B. "Family Cites Families" (7) — citations appearing in related family members, not necessarily in the '976 itself

These are informational; none is a §102 reference against the '976's claims.

• MX 9702723 A (1994‑10‑28 / 1998‑04‑30, Advanced Health Med‑E‑Systems) — "Prescription management system" (Mexican counterpart of the '255 reference).
• US 5,758,095 A (1995‑02‑24 / 1998‑05‑26, Albaum) — "Interactive medication ordering system."
• US 6,021,392 A (1996‑12‑09 / 2000‑02‑01, Pyxis Corp.) — "System and method for drug management."
• AU 8472098 A (1997‑06‑19 / 1999‑01‑04, Promedicus Systems) — "System for providing recommendations to physicians and for managing health care data."
• EP 1,135,052 A1 (1999‑02‑12 / 2001‑09‑26, Cygnus, Inc.) — "Devices and methods for frequent measurement of an analyte in a biological system" (glucose monitoring). Post‑priority and unrelated.
• CA 2,352,619 C (2001‑07‑06 / 2008‑02‑19, Premier Oilfield Equipment Co.) — "Mud tank cleaning system." Facially unrelated to the subject matter; I flag this as an apparent data artifact in the family‑citation table rather than genuine art.
• US 2006/0129433 A1 (2004‑12‑10 / 2006‑06‑15, Phanesh Koneru) — "Method and system for delivering high risk medical therapies." Post‑dates the patent and is a follow‑on, not prior art.

C. Bottom line on §102

• No reference among the 17 citations of record anticipates any of claims 1, 8, or 15 under 35 U.S.C. §102, because none discloses, in a single reference, the claimed combination of (i) a teratogenic drug, (ii) fetal‑risk counseling plus informed consent, and (iii) determination/registration of the patient's pregnancy‑or‑impregnation‑capability status as the condition precedent to permitting access.
• The two references that come closest on the mechanical/database elements are US 6,055,507 (Cunningham) — authorized prescribers/pharmacies + central‑database validation before dispensing — and US 6,014,631 (Merck‑Medco) — patient enrollment/subpopulation selection + physician communication. Both lack the teratogen‑specific and pregnancy‑verification elements, so they are at most §103 (obviousness) material, not §102 art.
• US 6,045,501 (same inventors, the priority document) and US 6,315,720 (later Celgene family member) disclose overlapping subject matter but are excluded as §102 "by another" prior art. This is the pivotal point: the reference with the closest disclosure is the applicant's own earlier patent, which by definition cannot anticipate.
• Notably, the patent's actual validity fight was fought on §103 and §101 (Alice) grounds, not §102: the PTAB invalidated the sibling '501 and '720 patents as obvious (Coalition for Affordable Drugs VI, IPR2015‑01092 and IPR2015‑01103), and the D.N.J. antitrust complaints asserted the "REMS patents" were invalid abstract ideas and/or procured by inequitable conduct — which reinforces that no clean §102 killer appears on the face of the '976.

D. Uncertainty / limitations (stated explicitly)

• I confirmed full text for US 5,845,255, US 6,014,631, US 5,594,637, US 6,055,507 and US 5,660,176; for the remaining citations the description above rests on the patent's own citation table (titles, dates, assignees) and my background knowledge, not a re‑retrieval of each document. I did not obtain a per‑reference examiner rejection record (e.g., the specific §102/§103 rejections and the art actually relied upon), which would be needed to state definitively why each reference was cited.
• The pre‑AIA §102(e) analysis above assumes an invention date no later than the 1998‑08‑28 priority date. If prosecution or litigation established a later actual invention date, the post‑1998 references (nos. 14–17) could theoretically come back into play — I found no such record.
• The current‑date discrepancy noted earlier persists: the system date is 2026‑10‑01 while the task header says April 26, 2026. It does not affect the prior‑art analysis, since all relevant art is pre‑2018.

If you want, I can next pull the actual USPTO file‑wrapper (PatentCenter) rejections and examiner‑cited art for application 09/964,068 to confirm which of these 17 references the examiner actually relied on versus which are merely listed.

I'll ground a few key references before building the § 103 analysis.

Obviousness Analysis — US 6,561,976 B2 under 35 U.S.C. § 103

Analyst memo. This is a technical/legal-analysis work product, not a legal opinion or a validity determination. Builds on the earlier summary sections without repeating them.

1. Governing law and framing

Statute. Because the '976 patent's earliest effective filing date (Aug. 28, 1998) precedes March 16, 2013, the pre-AIA version of § 103(a) controls. The claims are entitled to the Aug. 28, 1998 priority date through the chain 09/143,568 → 09/479,682 → 09/964,068 (all disclosed here). That date is therefore the critical date for § 102/§ 103 purposes, not the Sept. 26, 2001 filing date of the '976 application itself.

Standard. Graham v. John Deere Co., 383 U.S. 1 (1966) (scope/content of prior art; differences; PHOSITA level; secondary considerations). KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) supersedes rigid application of the teaching–suggestion–motivation test; a claim is obvious where a POSITA would (a) combine prior-art elements "according to known methods" to yield predictable results, (b) simply substitute one known element for another, (c) use a known technique to improve a similar device in the same way, or (d) apply a known technique to a known device ready for improvement. In re Keller, 642 F.2d 413 (CCPA 1981) and In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986) permit combining references where the combination, not each reference individually, supplies the motivation.

Important caveat on the "Prior Art" section. The reference lists on the Google Patents page are IDS/citation lists, not a § 102 prior-art qualification holding. Several listed documents post-date Aug. 28, 1998 and cannot be § 102 prior art against the '976 claims. Flagging this explicitly because it materially narrows the usable set:

The usable pre-8/28/1998 art is: US 5,299,121; 5,594,637; 5,619,991; 5,660,176; 5,758,095; 5,845,255; 5,974,203 (Canon — irrelevant); 6,014,631 (¶ 102(e), priority 4/2/1998); 6,055,507; 6,063,026; 6,131,090; 5,602,392 (Pyxis, from the Family-Cites list); plus MX 9702723 (foreign counterpart of the Mayaud '255 family, published 4/30/1998).

2. Person having ordinary skill in the art (PHOSITA)

The claims are method claims for a computer-administered drug-distribution/risk-management workflow. A defensible PHOSITA is a team or an individual with (i) a clinical/pharmacy background (R.Ph. or RN/MPH) with 2–3 years in drug-safety/pharmacovigilance or a pregnancy-prevention program, and (ii) 2+ years designing computerized prescription-management or medical-records systems (or a software engineer with that experience working with a clinician). The specification itself supplies the level-of-skill admission: "Suitable computer readable storage media … will be apparent to one of ordinary skill in the art, once armed with the teachings of the present application." That concession makes the "computer readable storage medium" limitation essentially conventional, so the inventive weight must reside in the workflow rules, not the hardware.

3. The specification's own admissions of prior art (strongest § 103 material)

The Background of the Invention is an admission that the core concept pre-existed:

• The Accutane (isotretinoin) Pregnancy Prevention Program (PPP), 1988 — a program of prescriber registration, patient education, mandatory consent, pregnancy testing, contraception counseling, blister packaging, and a patient survey (the Slone Epidemiology Unit study). The patent states: "A pregnancy prevention program was developed … The survey identified relatively low rates of pregnancy during Accutane treatment, which suggests that such a program can be effective." That sentence is an express teaching that the claimed approach works — the classic "reason to try it."
• The patent criticizes the PPP only for voluntariness ("enrollment … is voluntary") and the resulting representativeness problem. That is a motivation to make the known program mandatory and to register/track all participants — i.e., an express invitation to the very "register in a computer readable storage medium" steps of claims 1(a), 1(d), 8(a), and 15.
• Corroborating printed publication art (not on the page's list but corroborated by the Slone CV surfaced in the search): Mitchell AA, Van Bennekom C, Louik C, A pregnancy-prevention program in women of childbearing age receiving isotretinoin, N. Engl. J. Med. 1995;333:101–06 — a 1995 § 102(b) publication documenting precisely such a program.
• FDA briefing materials describing the PPP requirements confirm the substantive rules: two forms of contraception "for one month before, all during, and for one month after therapy," monthly pregnancy testing and counseling, and pregnancy testing within one week of starting therapy — FDA 3639b1c_06. Compare claim 15(b) and 15(c) verbatim.

4. Ground 1 — Claims 1–7 (and 8–14)

4.1 The combination

Primary references:

• US 5,758,095 (Albaum), "Interactive medication ordering system" — filed 2/24/1995, granted 5/26/1998. Networked physician-to-pharmacy ordering with authorized-access/security structure and pharmacy-side processing. (PDF)
• US 5,845,255 (Mayaud, Advanced Health Med-E-Systems), "Prescription management system" — priority 10/28/1994; granted 12/1/1998. Electronic prescription creation with retrieval of remote drug, formulary and patient-history data and "adverse indication review" presented to the prescriber before the prescription is completed.
• US 6,014,631 (Teagarden et al., Merck-Medco) — priority 4/2/1998, § 102(e). Explicitly teaches pre-selecting patients by first predetermined criteria, filtering to a secondary set "having a greater likelihood of benefiting," enrolling the patient, and capturing patient information (including "medical history, family history … compliance history") in a program that then communicates to the physician. (PDF)
• US 5,594,637 (Base Ten Systems), "System and method for assessing medical risk" — alternative/auxiliary for the risk-stratification step.
• The Accutane PPP as admitted prior art (plus Mitchell 1995) — supplies the teratogen-specific clinical substance.

4.2 Element-by-element mapping (claim 1)

Claim 8 is identical minus the words "consulting said medium" in step (f). Because claim 8 requires only generic "verifying," it is a fortiori obvious over the same combination — the database-consultation limitation of claim 1 is the harder one, so claim 8's broader scope is more exposed, not less.

4.3 Motivation to combine (Ground 1)

1. Same field, same problem. All of Albaum, Mayaud, Teagarden, and '637 are prescription/medical-informatics systems; the PPP is the recognized analogous teratogen-distribution protocol. KSR factor (a): combination of known elements by known methods.
2. Problem-solution nexus stated in the patent itself. The Background frames the problem (thalidomide teratogenicity; PPP voluntary/under-representative) and the solution (mandatory registration of prescriber/pharmacy/patient + gated dispensing). Where the specification articulates the problem and identifies a known program as "effective," the motivation is on the face of the document.
3. Reasonable expectation of success. PPP data showed lowered pregnancy rates; the patent concedes the approach "can be effective."
4. Design incentive / regulatory pressure (KSR "market forces"): the 1988 Accutane advisory-committee cycle and FDA letters to the NEJM (documented in the search results) created a clear incentive to strengthen drug-distribution controls.
5. Mental-process/human-activity elements are not a saving grace under § 103; they simply mean the PHOSITA pool includes the clinician and the informaticist.

5. Ground 2 — Claim 15 (pharmacy-eligibility method)

Claim 15 is, if anything, more vulnerable, because its four "deemed eligible" criteria are close to the published PPP/S.M.A.R.T. rules:

Claim 15(a) (authorize pharmacies to fill "only after confirming … eligibility") is the same database-gated dispensing step found in Albaum '095 and Teagarden '631.

Motivation: the numeric limits are not results of a newly discovered relationship — they are inventory/interval bookkeeping selected so the drug supply cannot outlast the testing/counseling cycle. That is a KSR "predictable variation" and "design choice" (cf. In re Aller, 220 F.2d 454 (CCPA 1955)).

6. Ground 3 — Dependent claims 2–7, 9–14, 16

• Claims 2, 9, 16 (thalidomide): 1 of 1 — the specification names thalidomide; the drug's teratogenicity and its PHS-distribution status are admitted prior art. Substituting the specific teratogen is a simple substitution (KSR factor b); the Accutane PPP shows the class-wide applicability of teratogen-distribution controls.
• Claims 3, 10 (prescription form): Albaum '095 / Mayaud '255.
• Claims 4, 11 (≤~28 days, no refills): PPP monthly supply; routine design choice; no unexpected result alleged.
• Claims 5, 12 (re-screen / pregnancy test before refill): PPP monthly testing and monthly counseling; Teagarden '631's iterative patient-contact/feedback loop.
• Claims 6, 13 (contraception counseling): PPP express requirement.
• Claims 7, 14 (provide a contraceptive device or formulation): weakest link for a physical item, but the step is a trivial logistical add-on (prescriber handing out samples); the benefit of reducing pregnancy risk during a teratogen course is inherent in the field. Expect a § 103 "obvious expedient" rationale (cf. DyStar Textilfarben v. C.H. Patrick, 464 F.3d 1356 (Fed. Cir. 2006)).

7. Secondary-considerations counteranalysis (the patentee's best response)

A validity challenge should anticipate these rebuttals, and I flag them as genuine non-obviousness arguments rather than dismissing them:

1. Teaching away / skepticism. Some contemporaneous FDA staff and the Health Research Group argued the only reliable way to prevent fetal exposure was to eliminate use in women of childbearing age (the Graham and Wolfe positions in the 1990 advisory-committee coverage: Citeline). A POSITA could argue the art pointed toward exclusion, not toward a gated-access program for women of childbearing potential.
2. Failure of others / long-felt need. Thalidomide's fetal-exposure problem dates to 1962; the Accutane PPP suffered documented non-compliance (voluntary enrollment; missed pregnancy tests; multi-month supplies — the 2007 comment/committee record). Long-felt need cutting back to 1962 with repeated failures is potent under Graham.
3. Unexpected results. The patent claims an "avoidance rate" above ~50% (preferably >95%). Whether that figure is unexpected versus a predicted improvement is an evidentiary question — the measured rate is not compared to a rigorous control in the specification, which weakens the showing.
4. Industry adoption / copying. The S.T.E.P.S. program was later cited by FDA as an input to S.M.A.R.T. (FDA 3639b1c_06), and competitors' follow-on developments exist; commercialization/near-copying evidence can rebut KSR's "predictable" framing.
5. Regulatory/statutory caveats. Because the claim steps are arguably "organizing human activity" and "mental processes," a validity defense may also travel under § 101 (Mayo/Alice) and § 112 (the "avoidance rate" language is a specification concept, not a claim limitation, so it cannot supply the missing written-description support for the numeric limits). These are outside the § 103 question posed but bear on overall vulnerability.

Counterweight: KSR and pre-AIA precedent permit a "common sense" motivation where the references are in the same field and the improvement is a predictable strengthening of a known program. The patent's own Background gives the challenger a "reason the improvement was needed" admission that largely neutralizes generic teaching-away arguments.

8. Bottom line

• Strongest § 103 case: Albaum '095 + Mayaud '255 + Teagarden '631 (+ Base Ten '637) + the Accutane PPP / Mitchell 1995 renders claims 1, 2, 5–14, and 15–16 prima facie obvious; claim 1's step (f) is the only limitation requiring real argument, and it is answered by routine database-gated dispensing/authorization art.
• Claim 8 (no database-consultation requirement) is the most exposed claim.
• Claim 15 is exposed because three of its four eligibility criteria are, nearly verbatim, the published Accutane PPP/S.M.A.R.T. rules, and the fourth is a routine supply-timing design choice.
• Claims 3, 4, 10, 11 (prescription form; ≤28 days) are routine design choices; claims 7 and 14 (provide a contraceptive device/formulation) are the least clearly met, resting on an "obvious expedient" rationale.
• Unexamined but flagged: whether any listed reference is a § 102(e) reference (dates are as-of-filing, not publication), and the unresolved Sept. 26 vs. Sept. 6, 2001 filing-date discrepancy carried over from the earlier summary — neither changes the Aug. 28, 1998 priority analysis.