US 6045501

I'll search for authoritative information on US 6045501, including any 2026 CAFC activity.

Let me check specifically for any 2026 appellate activity and the PTAB proceeding on this patent.

Let me check for any 2026 appellate activity and the litigation history.

US Patent 6,045,501 — Summary

Important scope note: I searched for the literal identifier 6045501 (i.e., US 6,045,501) only. I did not return results for neighboring family members with similar numbers — notably US 6,315,720 (the "Enhanced S.T.E.P.S." patent) or US 6,561,976 / 6,767,326 / 6,908,432 (continuations of the same family). Where those appear below it is only because they are formally related, and they are labeled as such.

Bibliographic data

Abstract (verbatim)

"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."

Plain-language overview of the independent claim

Claim 1 — A method of delivering a teratogenic drug to patients who need it, while preventing the drug from reaching a fetus. It has seven ordered steps:

• (a) Register, in a computer-readable storage medium, prescribers qualified to prescribe the drug.
• (b) Register, in that medium, pharmacies that will fill prescriptions for the drug.
• (c) Register the patients in the medium, including information about whether female patients can become pregnant and whether male patients can impregnate females.
• (d) Retrieve from the medium information identifying the subpopulation of female patients capable of becoming pregnant and male patients capable of impregnating females.
• (e) Provide that subpopulation with counseling information about the risks of fetal exposure to the drug.
• (f) Determine whether patients in that subpopulation are pregnant.
• (g) If a patient is determined not to be pregnant, authorize the registered pharmacies to fill prescriptions written by registered prescribers for those non-pregnant registered patients.

In substance: a gatekeeping/registry architecture in which only registered prescribers, registered pharmacies, and registered patients can participate, and in which the dispensing authorization is conditioned on counseling plus a negative pregnancy determination.

Dependent claims (2–10), all referencing claim 1 — claim 2 limits the drug to thalidomide; claim 3 brings male patients capable of impregnating females into the subpopulation; claim 4 specifies that the determination is by pregnancy testing; claim 5 requires prescriptions/fulfillment to be recorded in the medium; claim 6 makes refills authorizable only based on information in the medium; claim 7 limits fills to about 28 days; claim 8 requires distribution of literature warning of fetal effects; claim 9 adds contraception counseling; claim 10 adds providing a contraceptive device or formulation to patients capable of becoming pregnant.

Note on the specification vs. the claims: the specification also describes a second embodiment directed to "potentially hazardous" drugs generally, where the check is whether a patient has a condition for which the drug is contraindicated. That embodiment does not appear as an independent claim in the issued patent — claim 1 is the sole independent claim, and it is expressly limited to a teratogenic drug.

Procedural / litigation history (verified, and the most consequential fact about this patent)

• PTAB IPR2015-01092, Coalition for Affordable Drugs VI LLC v. Celgene Corp. — petition filed April 23, 2015; trial instituted October 27, 2015 on a single ground (obviousness over Powell, Mitchell, and Dishman). Final Written Decision entered October 26, 2016: claims 1–10 unpatentable as obvious under § 103. Celgene's request for rehearing was denied. (IPR2015-01092 case data; Paper 73, Oct. 26, 2016)
• Federal Circuit Appeal No. 2018-1171, consolidated with the '720 patent appeals — Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). The court affirmed the Board: all claims of the '501 patent invalid as obvious, and rejected Celgene's Fifth Amendment takings challenge to retroactive IPR of pre-AIA patents. (CourtListener)
• Rehearing en banc denied December 9, 2019 (mandate issued Dec. 16, 2019). Certiorari petition No. 19-1074 was filed (Celgene Corp. v. Peter), with the Supreme Court appendix reproducing the PTAB final written decision and Federal Circuit order. (SCOTUS docket PDF)
• District court actions involving the '501 patent include Celgene v. Lannett Holdings, D.N.J. 2:15-cv-00697; Celgene v. Natoo Pharma, D.N.J. 2:10-cv-05197; D.N.J. 2:07-cv-00286, 2:07-cv-04050, 2:07-cv-05485; and D.N.J. 2:19-cv-15343 (per the Google Patents litigation links). The '501 patent was also part of the broader antitrust/Mylan-era complaints in D.N.J. challenging Celgene's S.T.E.P.S./REMS "distribution method" patents.

On your specific request re: CAFC 2026 dockets

I could not find any 2026 Court of Appeals for the Federal Circuit docket involving US 6,045,501. The searches returned only an unrelated 2026 Federal Circuit case (Tramec Sloan LLC v. Surti, No. 2026-1117), which does not involve this patent. Stated plainly and with the appropriate uncertainty:

• I have no authoritative evidence of any 2026 CAFC activity on 6,045,501.
• Corroborating context: the patent expired August 28, 2018, and its claims were held unpatentable in 2016 and that holding was affirmed in 2019 with en banc and certiorari avenues exhausted by 2020. There is therefore no obvious live dispute that would generate a 2026 appeal concerning the '501 patent.
• Caveat on method: I do not have a live, direct query connection to the USPTO PatentCenter or the CAFC CM/ECF docket system. My checks were web-based (Google Patents, PTAB/PTAB-data aggregators, CourtListener, and the Supreme Court docket PDF). A definitive negative on 2026 CAFC activity would require a direct PACER/CM-ECF and USPTO PTAB docket query, which I could not perform here.

Uncertainty flags

• The expiration date (Aug 28, 2018) and Orange Book listing come from Google Patents/Orange Book-derived secondary sources; I did not directly pull the current Orange Book entry.
• The complete list of district court dockets is from Google Patents' auto-generated litigation links and may be incomplete or contain stale statuses.
• I found no search evidence that the '501 patent was ever asserted or appealed in 2026; treat any such claim as unverified.

I'll research litigation involving US patent 6045501. Let me run several searches.

Let me search for the specific district court cases listed and the PTAB proceeding.

Litigation Involving U.S. Patent No. 6,045,501

Patent at issue: U.S. 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"), inventors Marc Elsayed and Bruce Williams, assignee Celgene Corporation. Priority/filing date Aug. 28, 1998; issued April 4, 2000; expired Aug. 28, 2018. It is one of Celgene's so-called "REMS" / "Distribution Method Patents" listed in the Orange Book for THALOMID (thalidomide) and REVLIMID (lenalidomide).

The most authoritative single source I found is the appendix to the cert petition in Celgene Corp. v. Peter, No. 19-1074 (U.S.), which states that the petitioner "identifies six district court actions relating to the '501 patent." I then confirmed each docket independently. Below is the list.

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A. PTAB proceeding

1. Coalition For Affordable Drugs VI LLC v. Celgene Corporation — IPR2015-01092

• Forum: USPTO Patent Trial and Appeal Board
• Petitioner: Coalition For Affordable Drugs VI LLC; Patent Owner: Celgene Corporation
• Patent: U.S. 6,045,501 (application 09/143,569, Tech Center 3700)
• Filing date: April 23, 2015
• Institution decision: Oct. 27, 2015
• Status/outcome: Final Written Decision; proceeding terminated Oct. 26, 2016
• Counsel: Sarah Spires (petitioner); Francis Cerrito (respondent)
• Source: https://ipverse.greyb.com/ptab-web/cases/case-details/IPR2015-01092 ; Google Patents (which lists "PTAB case IPR2015-01092 filed (Final Written Decision)")

⚠️ Note: I could not confirm from the search results the substantive outcome (i.e., which, if any, claims were held unpatentable). The docket record shows institution and a Final Written Decision/termination, but the merits holding should be verified against the actual FWD document before you rely on it. Do not treat this entry as establishing that any claim was cancelled.

(Related Coalition for Affordable Drugs IPRs — IPR2015-01096, -01102, -01103, and -01169 — also name Celgene, but those target other patents (e.g., U.S. 6,315,720), not the '501 patent.)

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B. District court actions (all D. New Jersey) where '501 was asserted/at issue

These are the six cases the Celgene v. Peter cert appendix ties to the '501 patent:

Sources:

• Celgene Corp. v. Peter, No. 19-1074, Cert. Petition Appendix at 5 (listing the six '501-related cases): https://www.supremecourt.gov/DocketPDF/19/19-1074/[134252](/patent/134252)/20200226155847157_Celgene%20Corp.%20v.%20Peter%20-%20Cert%20Petition%20-%20Appendix.pdf
• Docket Alarm search "patent:(6045501)": https://www.docketalarm.com/search/?q=patent:(6045501)
• FJC IDB record for 2:10-cv-05197: https://www.courtlistener.com/docket/[4310166](/patent/4310166)/idb/celgene-corporation-v-natco-pharma-limited/

⚠️ Caveat on case numbers: Note that the six case numbers I cite come from the cert petition appendix (2:08-cv-03357, 2:07-cv-05485, 2:07-cv-04050, 2:07-cv-00286, 2:15-cv-00697, 2:10-cv-05197). The Google Patents litigation bar for this patent separately lists D.N.J. case numbers 2:19-cv-15343, 2:15-cv-00697, 2:10-cv-05197, 2:07-cv-05485, 2:07-cv-04050, and 2:07-cv-00286. The 2:19-cv-15343 entry (Celgene v. Dr. Reddy's, filed 7/12/2019) is a family-level "has litigation" flag on Google Patents — the docket shows the asserted patents there were U.S. 8,198,262 and 8,828,427, and the case ended in a consent judgment entered Feb. 23, 2022 with a "Final Judgment Regarding U.S. Patent Nos. 8,198,262 and 8,828,427." I could not confirm the '501 patent itself was asserted in 2:19-cv-15343, so treat that entry as family-associated rather than '501-specific unless verified.

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C. Follow-on antitrust / sham-litigation cases referencing the '501 patent

The '501 patent figures prominently as one of the allegedly fraudulently procured/mislisted "Distribution Method Patents" in the consolidated antitrust actions:

• In re Thalomid and Revlimid Purchaser Antitrust Litigation — D.N.J., lead cases 2:14-cv-06997 (Int'l Union of Bricklayers & Allied Craft Workers Local 1 Health Fund v. Celgene) and 2:19-cv-07532. Plaintiffs (direct purchasers, insurers, MSP Recovery, Humana, Cigna, et al.) allege Celgene improperly listed the distribution-method/REMS patents (including the '501) in the Orange Book and brought sham patent suits to block generics. Court opinions in this MDL address the REMS patents and Noerr-Pennington/sham issues. (Courtlistener 2:19-cv-07532, Doc. 446, June 6, 2024.)
• Cigna Corp. v. Celgene Corp. — E.D. Pa., 2:21-cv-00090 (filed Jan. 8, 2021), antitrust complaint referencing the Celgene sham litigation against Natco, Arrow, Watson, and Lannett.
• The Cigna Group v. Celgene Corp. — D.N.J. (filed June 24, 2025), 1:25-cv-05237, Sherman Act §2 antitrust complaint referencing the '501 REMS family and the REMS restrictions on Revlimid.
• Bristol Myers Squibb / Celgene antitrust complaint — D.N.J. (2026), addressing the "'501 REMS and '720 REMS families of patents claim methods of distributing a drug."

⚠️ These antitrust suits are not infringement actions on the '501 patent; the '501 is cited as background/one of the assertedly misused patents. Defendants in these antitrust matters include Celgene/Bristol Myers and various generic manufacturers (Natco, Alvogen, Dr. Reddy's, Cipla, Sun, Aurobindo, Teva, etc.).

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Summary

• Patent-specific litigation: The '501 patent was asserted by Celgene in six D.N.J. ANDA infringement suits (against Lannett, Natco/Arrow/Watson, and Barr in four actions), and was challenged in one PTAB IPR (IPR2015-01092, Coalition for Affordable Drugs VI LLC v. Celgene) that reached a Final Written Decision/termination on Oct. 26, 2016.
• Outcomes: The Natco/Revlimid action (2:10-cv-05197) terminated by consent/settlement Jan. 5, 2016; the earliest Barr action (2:07-cv-00286) was dismissed by stipulation May 21, 2010; the Lannett action was used as evidence in follow-on antitrust litigation. I was not able to retrieve a confirmed disposition for every Barr action (2:07-cv-04050, 2:07-cv-05485, 2:08-cv-03357) within the available search results.
• The '501 patent expired Aug. 28, 2018, and remains in multiple Orange Book listings and REMS-related product patents for THALOMID and REVLIMID.

Confidence note: The six-case list comes from a primary-source cert appendix and is reliable; the per-case outcomes for the Barr actions and the substantive holding of IPR2015-01092 are not fully confirmed by the sources I retrieved and should be verified against PACER/PTAB before being relied on.

I'll research the PTAB proceedings on this patent, reconciling the structured ODP block against the documented IPR identified in the patent record and prior sections.

Let me confirm the judge panel and check for any other proceedings on the '501 patent.

Reconciliation note (read first)

The structured "PTAB proceedings on file" block in this prompt states that the USPTO Open Data Portal returned no AIA trial proceedings for US 6,045,501. That block is wrong / stale, and I am flagging the contradiction explicitly. The patent's own Google Patents record states: "PTAB case IPR2015-01092 filed (Final Written Decision)", and the primary-source cert-petition appendix in Celgene Corp. v. Peter reproduces the Board's Final Written Decision. The likely cause is that the ODP's trial-proceeding dataset was not backfilled with 2015-era IPRs; the absence of a hit in that API is not evidence of "no PTAB activity." The proceeding list below is sourced from the PTAB record itself, not the ODP block.

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Proceedings overview

Total: 1 AIA trial proceeding on US 6,045,501 — IPR2015-01092 — in which all asserted claims (1–10) were invalidated as obvious; 0 proceedings active, 0 settled, 0 institution denials, and 0 claims sustained. Because the sole independent claim and all nine dependents stand canceled and the patent expired 2018-08-28, any demand letter, license demand, or infringement theory citing the '501 patent today has no case — the patent is dead at the claim level and dead at the term level.

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

• Type: Inter Partes Review (post-AIA, but challenging a pre-AIA patent; § 103 obviousness)
• Filed: 2015-04-23
• Status: Final Written Decision — claims 1–10 unpatentable (the record's verbatim status is "Final Written Decision"; the proceeding reached a merits verdict, not a settlement). Celgene's Request for Rehearing was denied, and the invalidation was affirmed on appeal.
• Judge panel: The public joint-sanctions order in the CFAD-VI/Celgene series (Paper 19, 2015-09-25) names Toni R. Scheiner, Michael P. Tierney, Michael W. Kim, Jacqueline Wright Bonilla, Grace Karaffa Oberman, and Tina E. Hulse. The specific three-APJ panel that authored the '501 FWD is not confirmed in the sources I retrieved (the parallel '720 FWDs were written by Tierney, Obermann, and Hulse). Do not assume the FWD panel equaled the sanctions panel.
• Petition grounds: Challenges to all ten claims (1–10) on a single ground — obviousness under 35 U.S.C. § 103 over Powell (thalidomide clinical use/dispensing), Mitchell (the Accutane/isotretinoin pregnancy-prevention program), and Dishman (the Clozaril/clozapine pharmacy-prescriber-patient registry and computerized "lockout"). No § 102 or § 112 grounds were instituted.
• Institution decision: Instituted 2015-10-27 (Paper 20), review of claims 1–10 on the sole Powell + Mitchell + Dishman ground. The Board found a reasonable likelihood Petitioner would prevail.
• Final Written Decision (Paper 73, 2016-10-26): The Board held that Petitioner CFAD showed by a preponderance of the evidence that claims 1–10 are unpatentable as obvious over Powell, Mitchell, and Dishman. Claim-level result: independent claim 1 canceled; dependent claims 2–10 canceled. No claim was held patentable. Key reasoning (quoted in the cert appendix and Federal Circuit opinion): a POSA "would have been led to combine, in the manner claimed, the disclosures … to address the problem of limiting thalidomide access to patients likely to suffer serious adverse side effects, including birth defects in a developing fetus." (Paper 73 at 23–24.) The Board also construed "a computer readable storage medium" under the broadest reasonable interpretation as not requiring a centralized database — so Dishman's decentralized "computerized lockout system" satisfied the limitation (Paper 73 at 10, 18–20). It rejected Celgene's objective-indicia evidence (long-felt need, industry praise, unexpected results) and gave the unexpected-results evidence "little weight" (Paper 73 at 28–29).
  • Contrast with the sibling '720 patent: there, on rehearing the Board modified the FWD to preserve claim 10. No such modification occurred on the '501 — Celgene's rehearing request as to claim 10 was denied (Paper 76, 2017-09-08), so claim 10 of the '501 is canceled along with the rest.
• Settlement / termination: None. Not settled — the case ran to a merits FWD; the parties did not terminate the trial.
• Appeal: Yes. Celgene appealed to the U.S. Court of Appeals for the Federal Circuit, Appeal No. 2018-1171, consolidated with the related '720 appeals into Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). Celgene raised three claim-1 issues (computer-readable-medium construction; obviousness of counseling male patients, argued against Powell's "no effects on male sperm" statement and the rabbit-based Mann study; and objective indicia) — all rejected. Disposition: "We therefore affirm the Board's determination that claims 1–10 of the '501 patent and claims 1–9 and 11–32 of the '720 patent are unpatentable as obvious." Celgene also lost its Fifth Amendment takings challenge to retroactive IPR of pre-AIA patents. Rehearing en banc denied 2019-12-09; mandate 2019-12-16. A certiorari petition (No. 19-1074, Celgene Corp. v. Peter) was filed; I did not confirm a cert disposition in the sources retrieved. (CourtListener, Celgene Corp. v. Peter; cert-petition appendix reproducing the FWD)
• Notable procedural event: Celgene moved for sanctions against CFAD VI (Kyle Bass-affiliated hedge-fund coalition) for abuse of process / pure profit motive. The Board denied the motion (2015-09-25), holding that an economic motive is not itself abuse of process, that the AIA does not require a competitive interest, and that Celgene had not alleged a non-meritorious challenge. This did not affect the merits.
• Defensive value: Every claim (1–10) is dead. Any infringement theory built on claim 1 — or on any dependent — is untenable, and pressing one would invite Rule 11 / § 285 exposure. Combined with expiration on 2018-08-28, there is no live theory of liability on this patent.

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Strategic summary

Claim status across US 6,045,501. As of the finality of Celgene Corp. v. Peter, claims 1–10 are CANCELED (held unpatentable as obvious). There are no sustained claims and no untested claims — the FWD reached all ten claims, the Board denied rehearing, and the Federal Circuit affirmed. This is materially different from the sibling '720 patent, where claim 10 survived via rehearing; on the '501 nothing survived. There is therefore no "surviving claim set" for a plaintiff to fall back to.

Estoppel landscape. Because the only petitioner (CFAD VI) won outright at the Board and on appeal, § 315(e)(2) estoppel is largely academic — the claims no longer exist to be asserted. For completeness: CFAD VI and its real parties in interest/privies are barred from re-raising in litigation any ground they raised or reasonably could have raised in IPR2015-01092 (the Powell + Mitchell + Dishman § 103 combination and any art a skilled searcher would have found). For a new defendant facing assertion, § 315(e)(2) does not bind you (you are not a privy of CFAD VI), but it does not matter — the patent expires/expired and the claims are canceled, so no prior-art ground needs to be developed at all. If a licensing entity nonetheless cites the '501, the correct response is a citation to Paper 73 and to Celgene v. Peter, not an invalidity case.

Pattern signals. This was a single-petition, single-proceeding challenge: of the five coordinated Coalition for Affordable Drugs VI IPRs against Celgene (IPR2015-01092/-01096/-01102/-01103/-01169), only '01092 targeted the '501; the others targeted the '720 and '517 patents. The petitioner was a hedge-fund-backed defensive/activist filer (Kyle Bass's CFAD entity) — not Unified Patents. The patent owner (Celgene) litigated hard: preliminary response, opposition to institution, a sanctions motion (lost), a rehearing request (denied), and a Federal Circuit appeal with an en banc petition and a cert petition to the Supreme Court (takings theory, rejected). This is an aggressive prosecution-of-appeal posture that failed at every level.

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Recommended next steps

• If you are a defendant or a recipient of a demand citing US 6,045,501: the patent is a nullity. Every asserted claim (1–10) was held unpatentable as obvious in IPR2015-01092, Paper 73 (2016-10-26), rehearing denied 2017-09-08 (Paper 76), and the invalidation was affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). Quote the disposition: "We therefore affirm the Board's determination that claims 1–10 of the '501 patent … are unpatentable as obvious." The patent also expired 2018-08-28. A demand on the '501 is meritless on its face.
• FWD access: the FWD is PTAB Paper 73 in IPR2015-01092; retrieve documents via USPTO PTAB E2E (the proceeding's public-information page is reachable at ptacts.uspto.gov/ptacts/public-informations/petitions/1462272) and corroborate via Docket Alarm IPR2015-01092. The Federal Circuit opinion is on CourtListener.
• No active proceedings to monitor. There are no pending PTAB trials on this patent and no live Federal Circuit appeals I could identify — the appeal chain ended with the 2019 affirmance, rehearing denial, and the 2019 cert petition. There are no institution deadlines, hearing dates, or statutory FWD dates to track.
• Caveats / not verified: (1) the exact three-APJ panel of the '501 FWD (only the joint-sanctions panel is confirmed); (2) the certiorari disposition for No. 19-1074; (3) whether the USPTO has formally issued a cancellation certificate for '501 claims 1–10 (expected after the Federal Circuit mandate, but not confirmed in the sources retrieved). None of these affect the practical conclusion that the claims are canceled, but confirm them against PTAB E2E / PatentCenter before filing anything that states them as fact.

I'll research the assignment/ownership record for US 6,045,501. Let me run several targeted searches.

Let me look for the specific assignment records and the correspondent/attorney of record.

Let me search for the specific assignment record details and any later ownership changes.

I have enough to construct the ownership reconstruction. One important methodological caveat up front: my research was web-based (Google Patents legal events, uspto.report, Justia, court filings reproducing USPTO recordation notices, and secondary aggregators). I was not able to open a live session against assignmentcenter.uspto.gov and pull the digitized reel/frame image for this patent, so I could not retrieve the reel/frame number or the correspondent of record for the single assignment I did confirm. I flag every place that limitation bites.

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Inventors

Unusual-pattern check — negative (inverse pattern): I found no evidence that either inventor departed Celgene within 12 months of filing, and the record cuts the other way. Williams is a recurring named inventor across the entire S.T.E.P.S./REMS distribution-method family — the '720 (US 6,315,720), '977, '784, '399, '018, '566, '886 and '531 patents — spanning 1998 through 2012. He also executed a 2001-01-05 inventor→Celgene assignment for the sibling '720 family application (recorded 2003-04-23, Reel 013982/0697). That is a career employee, not a departing founder. There is no "inventors bail out early → fire-sale" signature here.

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Original assignee

Celgene Corporation (Delaware corporation). Address at the time of the '501 filing: 7 Powder Horn Drive, Warren, NJ 07059; later filings use 86 Morris Avenue, Summit, NJ 07901.

• Primary line of business: pharmaceutical manufacturer. Celgene is the operating company that actually shipped products embodying the claims.
• Products embodying the asserted subject matter: THALOMID (thalidomide) under the FDA-mandated S.T.E.P.S. distribution program, and REVLIMID (lenalidomide) under the RevAssist REMS program. The '501 patent was listed in the Orange Book for both (and, in later editions, for POMALYST). The claims recite precisely the registry/counseling/pregnancy-test/dispensing-authorization architecture those programs implemented. (Orange Book-derived listing, patent code U-694/U-731/U-371)
• Current status: operating subsidiary — acquired by Bristol Myers Squibb (deal closed November 2019); Celgene continues to exist as a BMS wholly-owned subsidiary, so no vesting or name-change assignment of the '501 was required or recorded. The '501 patent itself expired 2018-08-28.

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Assignment timeline

I could retrieve exactly one recorded assignment touching the '501 itself. I state it plainly, then explain what I could not verify.

• 1998-08-[28 or earlier] (executed — exact execution date not retrievable) / recorded 1998-10-26 — Reel/Frame: not retrieved
  • Conveyance: Assignment (Assignment of Assignors' Interest — "SEE DOCUMENT FOR DETAILS")
  • Assignor: Elsayed, Marc; Williams, Bruce (the two named inventors)
  • Assignee: Celgene Corporation
  • Correspondent: not retrieved — see limitation note below. Because I have only one link in the chain and I could not obtain the correspondent field, I cannot run the "repeat correspondent across the chain" test, and I will not guess at a firm name.
  • Context: Routine inventor→employer assignment, recorded ~2 months after the 1998-08-28 filing. This is the ordinary employee-invention conveyance, not an acquisition, fire-sale, or transfer-to-asserter.

No later assignment was found. Every ownership-relevant event after 1998 that I can see is not a recorded assignment:

• The 2000-01-07 continuation (09/479,682) and the downstream continuations ('976, '326, '432, '984, '763, '188) were routinely assigned to Celgene; the family stayed inside Celgene.
• The 2019 BMS acquisition of Celgene was a stock/merger transaction; no separate assignment of the '501 to BMS was recorded (and none was needed).
• The 2016 PTAB cancellation (IPR2015-01092) and 2019 affirmance (see the previously generated sections) did not produce a transfer — an invalidated patent simply stops being an asset.

⚠️ Verification limitation (important). I could not directly open https://assignmentcenter.uspto.gov/ or https://assignment.uspto.gov/patent/index.html in this session, nor retrieve the assignment image/recordation notice for the '501's 1998 record. The existence of that single assignment and its recorded date of 1998-10-26 come from the Google Patents legal-events strip (which shows "1998-10-26 Assigned to CELGENE CORPORATION … ASSIGNMENT OF ASSIGNORS' INTEREST … Assignors: ELSAYED, MARC, WILLIAMS, BRUCE"). The reel/frame and correspondent fields are therefore unverified. Before relying on this ownership reconstruction, pull the record directly at the Assignment Center by patent number 6045501 (application 09/143,569) and confirm (a) whether there is exactly one record, (b) its reel/frame, and (c) the correspondent of record.

Because there is one record, I do not stop here.

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Timeline diagram

timeline
    title Ownership of US 6045501
    1998 : Inventors file application Aug 28
         : Inventors assign to Celgene Oct 26
    2000 : Patent issues Apr 4
    2018 : Patent expires Aug 28
    2019 : Bristol Myers Squibb acquires Celgene

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NPE / troll-pattern signals

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Verdict

Operating-company assertion.

The ownership record for US 6,045,501 is a single, unremarkable inventor→employer assignment to Celgene Corporation, recorded 1998-10-26 (Elsayed & Williams → Celgene), with no subsequent transfer of any kind — no LLC, no securitization, no fire-sale, and no defensive-aggregator endpoint. Celgene is a genuine pharmaceutical manufacturer that shipped products embodying the claims (THALOMID/S.T.E.P.S. and REVLIMID/RevAssist) and enforced the '501 directly against generic competitors (Barr, Natco/Arrow/Watson, Lannett); the chain therefore reads as operating-company assertion, not NPE activity. The one residual evidentiary gap is the reel/frame and correspondent of record for the 1998 assignment, which I could not verify this session.

Verify at: USPTO Assignment Center — search patent 6045501 (legacy mirror: https://assignment.uspto.gov/patent/index.html). Search application 09/143,569 as well, since pre-issuance assignments are indexed to the application number.

I'll research the prior art cited for US 6,045,501. Let me search for each cited reference.

Let me research the additional family-cited prior art and the IPR prior art.

Prior Art Analysis — U.S. Patent No. 6,045,501

Scope discipline: Every reference below is tied to the front page of US 6,045,501 itself (application 09/143,569) as shown on its Google Patents record. I did not import art from neighboring family numbers (e.g., US 6,315,720, US 6,561,976, US 6,767,326, US 6,908,432), except where a reference is expressly listed in the '501 family's citation tables — and in those cases I label them as family-cited rather than '501-specific.

Method caveat: My checks were web-based (Google Patents, uspto.report, everypatent, espacenet, freepatentsonline, patentimages PDFs). I did not run a native USPTO PatentCenter full-text query or a PACER/PTAB docket pull in this session, so a first-page citation count should be treated as corroborated but not docket-verified.

Critical framing up front: Under 35 U.S.C. § 102, a reference anticipates only if it discloses every limitation of the claim, arranged as the claim requires. None of the references cited on the face of the '501 discloses all seven steps of claim 1 (register prescribers + register pharmacies + register patients with fertility data + retrieve the fertile subpopulation + counsel that subpopulation + determine pregnancy + authorize registered pharmacies to fill registered prescribers' prescriptions for non-pregnant registered patients). Consequently, no cited reference anticipates claim 1 or, derivatively, any of dependent claims 2–10. The cited art is obviousness (§ 103) art, not anticipation art. That is consistent with the actual outcome of this patent's challenge: per the prior sections of this analysis, IPR2015-01092 invalidated claims 1–10 as obvious over Powell, Mitchell, and Dishman (FWD Oct. 26, 2016), affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). Notably, Powell, Mitchell, and Dishman do not appear on the face of the '501 — a substantive point worth flagging as a discrepancy between the examiner's art and the art that actually killed the claims.

Because the '501 was filed August 28, 1998, pre-AIA § 102 governs.

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Part A — The four "Patent Citations" on the face of the '501 (examiner-cited)

A1. US 5,299,121 — "Non-prescription drug medication screening system"

Description: A pharmacy-deployed expert system that prompts a customer for basic information (name, gender, date of birth), has the customer select a symptom category, runs a symptom knowledgebase and asks follow-up questions, then outputs a list of recommended non-prescription products and prints a session report with warnings/usage restrictions. The specification attaches ~2,300 lines of C source and 134 weighted expert-system rules (per Greg Aharonian, Internet Patent News Service, 1994).

§ 102 analysis — potential anticipation of claims:

• Claim 1: No. The reference is directed to over-the-counter (non-prescription) selection, not delivery of a teratogenic drug under prescription. It contains no registering of prescribers, no registering of pharmacies as dispensers of a controlled prescription, no authorizing of pharmacies to fill prescriptions, no pregnancy determination. Not anticipated.
• Claims 2–10: Derivatively no, because each depends from claim 1 and so includes all of claim 1's limitations.
• What it does teach (relevant to § 103): computer capture of customer age/gender (from which child-bearing potential can be inferred), screening questions that touch on pregnancy/nursing status (sheet 2e of the reference includes "FEMALE? … OR A NURSING MOTHER?" logic), and automated generation of warning text — i.e., isolated elements of claims 1(c), 1(e), and 8.

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A2. US 5,594,637 — "System and method for assessing medical risk"

Description: A computer system that transforms patient test-marker data with patient variables, compares the transformed data against mean/standard-deviation values from a database of previously assessed patients, and assesses the likelihood of a given outcome — with a heavy emphasis on prenatal-risk assessment (test markers AFP, hCG, uE3; variables age, race, weight, diabetic status). It also validates data against predefined criteria. Related family members include US 5,492,117 and US 5,796,759.

§ 102 analysis — potential anticipation of claims:

• Claim 1: No. This is a diagnostic risk-calculation system. It does not register prescribers or pharmacies, does not authorize dispensing, and does not involve delivery of a teratogenic drug. The only overlap is generic "assessing medical risk" and the prenatal context — not the claimed regulatory workflow. Not anticipated.
• Claims 2–10: Derivatively no.
• What it does teach (relevant to § 103): the notion of a database of patient data used to categorize/monitor a population and generate outputs (analogous in a very general way to claims 1(c)–(d)), and its prenatal marker analysis is thematically proximate to claim 4's "pregnancy testing" — but it computes a risk, it does not determine pregnancy as the claim requires.

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A3. US 5,619,991 — "Delivery of medical services using electronic data communications"

Description: A networked ("e-doc") system for diagnosing/treating patients via electronic data communications. Networked entities include a patient PC, physician PC, pharmacy PC, diagnostic center, hospital, ambulance service, a medical database service, the CDC, and a "LocalLab." The e-doc can send a prescription for medicine to the patient's pharmacy, order diagnostic tests, receive test results, and submit "epidemiological transaction records" to a database that correlates records to help confirm diagnoses.

§ 102 analysis — potential anticipation of claims:

• Claim 1: No, but this is the closest of the four to the network architecture. It ties together a prescriber, a pharmacy, a test facility, and a central database over a network — i.e., elements resembling claims 1(a)–(b) and 1(f). However it lacks any registration gate for prescribers/pharmacies/patients, any subpopulation retrieval by fertility, any structured counseling, and any conditional dispensing authorization keyed to a pregnancy determination. Not anticipated.
• Claims 2–10: Derivatively no.
• What it does teach (relevant to § 103): electronic transmission of a prescription from prescriber to pharmacy (claim 1(b) environment), test ordering/result return (relevant to claim 4's pregnancy testing), and a central epidemiological database keyed to patient records (relevant to claims 1(c) and 5).

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A4. US 5,660,176 — "Computerized medical diagnostic and treatment advice system"

Description: A computerized, knowledge-based medical diagnostic and treatment-advice system delivering advice to the public over a telephone network or the Internet (or stand-alone), using expert-system "scripts." Part of a very large First Opinion family (US 5,594,638; 6,206,829; 6,022,315; 6,113,540; etc.). It is a diagnosis/advice engine, not a drug-distribution control system.

§ 102 analysis — potential anticipation of claims:

• Claim 1: No. Diagnostic advice delivery is not a method of delivering a teratogenic drug with registration/counseling/pregnancy-test/authorization steps. Not anticipated.
• Claims 2–10: Derivatively no.
• What it does teach (relevant to § 103): purely generic medical-informatics background — computer storage of patient records and generation of advice. Its § 103 value in the '501 challenge would be minimal absent the core distribution-control teachings.

Part A summary table

All four issued more than one year before the '501 filing, so each is available under pre-AIA § 102(b) as a US patent (and under § 103). None alone, and no combination of just these four, supplies the teratogen-distribution gatekeeping of claim 1.

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Part B — Family-cited references (listed in the '501 family's citation tables)

These appear under "Family Cites Families (20)" on the Google Patents record — i.e., they are cited across the '501's continuation family, not necessarily against the '501 itself. I flag the ones that are not prior art to the '501 because they post-date the Aug. 28, 1998 filing.

B1. US 5,845,255 — "Prescription management system"

Description: Electronic prescription creation at the point of care, with remote drug/formulary and patient-history databases, drug-selection by patient condition, and advisories (potentially including contraindication warnings) presented before the prescription is completed. Continued in US 7,072,840 and US 7,574,370.

§ 102 analysis: No anticipation. Even reading it generously, it lacks the pharmacy-registration gate, the fertility-subpopulation retrieval, the counseling step, the pregnancy determination, and the conditional dispensing authorization. It is available as pre-AIA § 102(e) art (US application filed Oct. 2, 1997, before the '501's Aug. 28, 1998 filing) and is strong § 103 art for claims 1(a)/(b) and claim 8 (advisories/warnings) and claim 5 (recordation of prescriptions).

B2. US 6,014,631 — "Computer implemented patient medication review system and process…"

Description: Computerized review of patient medication (drug-utilization/claims context). Filed before the '501 filing but issued after → available as pre-AIA § 102(e) art.

§ 102 analysis: No anticipation of claim 1. Relevant to claim 5 (recording of prescriptions/fulfillment in a database).

B3. US 5,758,095 — "Interactive medication ordering system"

Description: Physician-interactive medication ordering. Filed 1995 → § 102(e) art (issued 1998-05-26, within one year of the '501 filing, so not § 102(b)). No anticipation; § 103 relevance only.

B4. US 5,832,449 — "Method and system for dispensing, tracking and managing pharmaceutical trial products"

Description: Dispensing/tracking of pharmaceutical (clinical-trial) supplies — a restricted-distribution and accountability model. Filed 1995 → § 102(e) art. No anticipation of claim 1, but conceptually relevant to the "pharmacy may not receive more drug unless it can account for all previously dispensed" concept described in the '501 specification, and to claims 5–6 (tracking/recording, refill control).

B5. US 6,021,392 — "System and method for drug management"

Description: Automated drug-management/dispensing accountability (Pyxis-style). Filed 1996 → § 102(e) art. No anticipation; § 103 relevance to distribution control.

B6. US 5,924,074 — "Electronic medical records system"

Description: Electronic medical record storage. Filed 1996 → § 102(e) art. No anticipation; generic record-keeping background.

B7. US 6,063,026 — "Medical diagnostic analysis system"

Filed 1995 → § 102(e) art. Diagnostic analysis; no anticipation.

B8. US 6,131,090 — "Method and system for providing controlled access to information stored on a portable recording medium"

Filed 1997 → § 102(e) art for controlled-access concepts; no anticipation.

B9. WO 1999/010829 A1 — "Health care system and method for physician order entry"

Timing note: publication post-dates the '501 filing, but a PCT designating the US and published in English can be pre-AIA § 102(e) art as of its international filing date (Aug. 22, 1997). No anticipation; § 103 relevance to physician order entry.

B10. US 2006/0129433 A1 — "Method and system for delivering high risk medical therapies"

Not prior art to the '501 — filed over six years after the '501's Aug. 28, 1998 filing. It appears in the family citation table because it cites the '501 family; it is a child/descendant citation, not § 102 art.

B11. References in the family table that are not § 102 art to the '501

These post-date the '501 filing (or are unrelated), and I flag them so they are not mistaken for prior art:

• US 6,202,923 B1 (Innovation Associates, "Automated pharmacy") — filed Aug. 23, 1999 → after the '501 filing.
• EP 1,135,052 A1 (Cygnus, Inc., analyte measurement) — filed Feb. 12, 1999 → after; also technically unrelated (biosensor).
• GB 9904585 D0 (Gemini Research Limited, clinical/diagnostic database) — filed Feb. 26, 1999 → after.
• AU 8472098 A (Promedicus Systems) — filed June 19, 1997; published Jan. 4, 1999 → publication after the '501 filing.
• US 6,128,620 (Lemed Inc., "Medical database for litigation") — filed Feb. 2, 1999 → after.
• MX 9702723 A — Mexican publication (1998-04-30) corresponding to the US 5,845,255 family; if verified as published Apr. 30, 1998 it could be § 102(a) art, but its content is the same prescription-management subject matter as B1 and adds no new disclosure.
• CA 2352619 C ("Mud tank cleaning system," Premier Oilfield Equipment) — clearly mis-mapped in the automated citation table; not relevant to the '501.

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Part C — The art that actually invalidated the patent (for completeness)

Per the earlier sections of this analysis, IPR2015-01092 (Coalition for Affordable Drugs VI LLC v. Celgene) invalidated claims 1–10 as obvious over Powell, Mitchell, and Dishman, and the Federal Circuit affirmed (Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019)).

Important caveat: Those three references do not appear among the front-page citations of the '501 above. I could not retrieve the full text of Powell, Mitchell, and Dishman in this session, so I cannot characterize their disclosures with specificity or assign them to individual claims. What is verifiable from the case record is that the Board's ground was § 103 obviousness, not § 102 anticipation — reinforcing the conclusion that no single reference anticipates any claim of the '501.

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Bottom line on § 102

Confidence / verification flags

• The four "Patent Citations" and their bibliographic data (US 5,299,121; 5,594,637; 5,619,991; 5,660,176) are confirmed from Google Patents, everypatent, and uspto.report.
• The filing/issue dates of the family-cited references are drawn from the Google Patents citation table and secondary aggregators; the § 102 subsection assignments (102(a)/(b)/(e)) are my legal analysis, not a source statement, and should be re-verified against the actual front pages before being relied on.
• I could not retrieve the disclosures of Powell, Mitchell, or Dishman in this session; treat any claim about their specific teachings as unverified.
• The MX 9702723 and CA 2352619 entries carry unresolved mapping questions and should not be relied on without secondary confirmation.

I'll ground the prior-art reference identities before mapping them to the claims.

Obviousness Analysis — U.S. Patent 6,045,501 under 35 U.S.C. § 103

Scope note. This section assumes the claim set, bibliographic data, POSA, and procedural history already established in the prior sections of this analysis. I do not re-describe claim 1 or repeat the PTAB/litigation narrative. I do add new material: (i) a reference-by-reference prior-art admissibility audit drawn from the Prior Art section of this page (the four examiner-cited patent references, the family-cited references, and the prior-art-keyword block); (ii) the adjudicated Powell + Mitchell + Dishman combination with an element-by-element mapping; (iii) three alternative § 103 combinations built from the patent-literature references on the page; and (iv) the motivation-to-combine rationales and the secondary-considerations record.

Two corrections to the earlier sections (flagged, per scope rules):

1. The Litigation summary section expressly cautioned that the substantive outcome of IPR2015-01092 was unconfirmed and stated "do not treat this entry as establishing that any claim was cancelled." That caveat is superseded. The Final Written Decision (Paper 73) and the cert-petition appendix confirm claims 1–10 unpatentable as obvious, affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). My analysis below proceeds on the confirmed record.
2. Minor date artifact: this task states "Current Date: April 26, 2026," while the source page and earlier sections are stamped 2026-10-01. Nothing in the § 103 analysis turns on it; noting it only because instructions require flagging contradictions.

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I. The governing framework and the person of ordinary skill

Priority / critical date. August 28, 1998 (no earlier priority; the '501 is the family root). Pre-AIA § 103(a) applies, with § 102(b) available for any reference published more than one year before that date (i.e., before August 28, 1997), and § 102(a)/(e) for references published/granted on earlier-filed applications.

POSA. As established in the IPR record, the Board worked from Petitioner's expert Dr. Fudin's definition: a Pharm.D. or B.S. in pharmacy with roughly 5–10 years' experience and a state license — i.e., a practicing pharmacist with drug-distribution and dispensing-control experience, not a database engineer. This definition is load-bearing: Celgene's rebuttal expert argued the Fudin POSA "would not have been capable of designing or implementing the claimed systems," which the Board rejected as inconsistent with the POSA's practical knowledge of restricted-distribution programs. For § 103 purposes the POSA is charged with knowledge of the design of the distribution programs themselves (registries, eligibility checks, testing cadences, limited fills), which is precisely what claims 1–10 recite.

Claim construction. Under the then-applicable broadest reasonable interpretation, "a computer readable storage medium" was construed not to require a centralized database (Paper 73 at 10–11, 18–20). This construction is outcome-determinative for the § 103 analysis: it lets a decentralized registry (Dishman) satisfy the limitation, and the Board additionally held, in the alternative, that even a centralized database would have been obvious (Paper 73 at 11, 20; affirmed in the en banc petition excerpt: "Even under Celgene's claim construction, the Board determined that its ultimate determination on obviousness would not change"). So the obviousness holding does not depend on winning the construction fight.

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II. Prior-art audit — references appearing in the Prior Art section of this page

The page's prior-art sections supply (a) four examiner-cited U.S. patents, (b) twenty family-cited items, and (c) a prior-art keyword block ("drug, patients, patient, registered, prescriber") that corroborates the field of search. Critically, the page's own citation tables are thin relative to the art that actually mattered — the three references that killed the claims (Powell, Mitchell, Dishman) are journal articles that appear only in the IPR/court record, not in the patent's IDS tables. That asymmetry is itself the central § 103 insight: the invention sat at the intersection of two art areas (teratogen risk management and pharmacy registry systems), and the USPTO's examiner searched only the second.

A. Examiner-cited references ("Patent Citations (4)")

Note on the last row's date: US 5,660,176 issued 1997-08-26, which is just more than one year before the 1998-08-28 filing date. It qualifies under § 102(b) by a two-day margin. If a priority date earlier than the filing date were ever established, this reference would drop to § 102(a)/(e). Flagging because the margin is unusually thin.

B. Family-cited references ("Family Cites Families (20)") — filtered for relevance and admissibility

Takeaway from the audit: at least eight pre-critical-date patent references in the '501's own citation lists disclose every systemic element the claims recite (registry of participants; eligibility checks; remote authorization to dispense; limited supply; refill control; DUR/risk flags). The '501's novelty, if any, had to reside in the coupling of that infrastructure to teratogen-specific clinical steps (counseling, pregnancy determination). That is exactly the coupling Mitchell supplies.

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III. The adjudicated combination: Powell + Mitchell + Dishman (all § 102(b))

This is the combination the Board sustained and the Federal Circuit affirmed. Citations: Coalition for Affordable Drugs VI LLC v. Celgene Corp., IPR2015-01092, Paper 73 at 13, 23–24 (P.T.A.B. Oct. 26, 2016), reproduced at the cert appendix (SCOTUS 19-1074 App. 1a–); FWD PDF (Finnegan); FWD PDF (Docket Alarm).

A. What each reference teaches

Powell (R.J. Powell & J.M.M. Gardner-Medwin, Guideline for the Clinical Use and Dispensing of Thalidomide, 70 Postgrad. Med. J. 901–904 (1994); Ex. 1005) — Guidelines for restricting thalidomide distribution:

• Thalidomide to be dispensed only through named-patient / hospital prescriber channels, with a defined set of "qualified" prescribers.
• Patients of childbearing potential must be excluded from pregnancy by a negative pregnancy test within 2 weeks prior to starting therapy; treatment must stop immediately on a missed period, with a further pregnancy test and counseling.
• Supplies restricted; prescribers instructed to counsel on teratogenic risk.

Mitchell (Allen A. Mitchell et al., A Pregnancy-Prevention Program in Women of Childbearing Age Receiving Isotretinoin, 333:2 New Eng. J. Med. 101–06 (July 13, 1995); Ex. 1006) — the Accutane/isotretinoin Pregnancy Prevention Program (PPP):

• Registration/enrollment of participating physicians and their patients in a program sponsored by the manufacturer.
• Distribution of educational materials warning of teratogenic risk; informed-consent/agreement paperwork.
• Mandatory pregnancy testing (including serum testing) before and during treatment; contraception counseling and referral; forms for a "contraception referral program" (Ex. 1002 ¶¶ 168–169).
• Compulsory patient surveys capturing behavioral/compliance data.
• Express statement that "experience gained with [Accutane] can serve as a basis for considering how [thalidomide] should be used and monitored, with a view to ensuring that pregnancies and malformations are reduced to an absolute minimum" (Ex. 1006 at 105) — quoted at Paper 73 and in the cert appendix.

Dishman (Benjamin R. Dishman et al., Pharmacists' Role in Clozapine Therapy at a Veterans Affairs Medical Center, 51 Am. J. Hosp. Pharm. 899–901 (Apr. 1, 1994); Ex. 1007) — the Clozaril National Registry / patient monitoring system:

• Manufacturer requires all prescribers and patients to be registered with a national registry; pharmacies and pharmacists participate in the restricted channel.
• Periodic diagnostic testing (weekly WBC counts) with results gating each successive short-interval supply (one week).
• A computerized "lockout" — the system refuses to release drug unless eligibility/testing criteria are met.
• Notes that pregnancy is a contraindication to clozapine therapy (Ex. 1007 at 900).

B. Element-by-element mapping of claim 1

C. The motivation to combine — four independent rationales

1. Express suggestion (the strongest hook). Mitchell itself directs the reader to thalidomide: the Accutane PPP's "experience … can serve as a basis for considering how [thalidomide] should be used and monitored." A reference that names the target drug and tells the artisan to transfer the method is the paradigm of an explicit motivation. No secondary "why combine" inference is even needed for Mitchell→thalidomide's indication.
2. Same field of endeavor / reasonably pertinent art. All three references are, as the Board found, "focus[ed] on controlling the distribution of a drug" — Powell on thalidomide specifically, Mitchell on a teratogen, Dishman on a drug with lethal idiosyncratic toxicity. They are the same problem space (restricted distribution of dangerous drugs), and Powell and Dishman are "specifically directed to clinical operations." This defeats Celgene's argument that the references were "directed to a different audience" — analogous-art status does not require identical patient populations (schizophrenia vs. acne vs. ENL); it requires the same problem, which is drug-induced harm prevention.
3. Combination of known elements with a predictable result (KSR). Each element — registry, eligibility check, counseling, test-gated release, short-interval supply — was a known tool with a known function. Combining Mitchell's clinical controls (counseling, testing) with Dishman's informatic controls (registry, lockout, interval limits) to build a thalidomide program is the "predictable use of prior art elements according to their established functions." The Board framed it as "a combination of known elements for their known use to achieve a predictable result."
4. Design incentive / market and regulatory pressure. Thalidomide's history (withdrawal in 1962 for birth defects) and the contemporaneous use of the PPP and the Clozaril registry created an obvious design incentive: use the most restrictive proven toolset available. The prior-programs' measured success (the PPP was shown to be associated with relatively low pregnancy rates) supplied the reasonable expectation of success the Board credited, notwithstanding Celgene's evidence that the PPP and the clozapine system were imperfect (538 fetal isotretinoin exposures; persisting clozapine deaths). Imperfect prior programs do not defeat obviousness where they teach the architecture; they merely define the baseline the artisan starts from.

Teaching-away argument, rejected. Celgene argued Powell's statement that "[n]o effects on male sperm are recognized" taught away from counseling males (claim 1(e) as applied to males). The Board found the statement, read in context, concerned thalidomide's contraceptive effect on sperm rather than its teratogenic effect, and that Dr. Fudin's testimony — supported by the Mann study (thalidomide caused negative effects on rabbit sperm and on resulting fetuses, Ex. 1002/Ex. 2061) — established that a POSA would have understood the need to counsel males capable of impregnating females. The Federal Circuit found substantial evidence for this. Practically: one arguably ambiguous sentence in Powell cannot rebut an affirmative expert showing of POSA understanding.

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IV. Alternative § 103 combinations from the prior art on this page

These matter for two reasons: (i) they show the claims fall to art the examiner did have in front of it, which forecloses any argument that the § 103 case depended on obscure references; and (ii) they substitute cleanly if any member of Powell/Mitchell/Dishman were disqualified (e.g., on publication-date or authentication grounds).

Combination A — Mitchell + Dishman + Base Ten (US 5,594,637) + Lucent (US 5,619,991)

• Coverage. Mitchell supplies steps (e) counseling/education, (f) pregnancy determination, and the PPP's registration/informed-consent framework for (c)–(d). Dishman supplies the registry architecture for (a)–(b) and the gating/authorization mechanism for (g). Base Ten supplies automated risk scoring and thresholding — the computational realization of "retrieving … information identifying a subpopulation" (steps (c)–(d)) — and Lucent supplies network-mediated delivery of medical services, i.e., the mechanism by which a registered pharmacy remotely queries/obtains authorization (step (g)).
• Motivation. Base Ten and Lucent are both general-purpose medical-informatics platforms whose known function is exactly the function the claim assigns them (risk stratification; remote service delivery). Under KSR, arranging a registry-based distribution program on a networked risk-assessment platform is the predictable application of known tools. A POSA building a national thalidomide control program in 1998 — the era of the Clozaril registry and managed-care DUR systems — would have looked to networked pharmacy systems as the implementation vehicle, not as a source of new pharmacology.
• Weakness. Base Ten and Lucent do not themselves address pregnancy or teratogens; they are infrastructure art. That is why this combination depends on Mitchell and Dishman carrying the clinical content. This is a § 103 combination, not an anticipation theory — each reference need only contribute its own teaching.

Combination B — Cunningham (US 5,832,449) + Advanced Health Med-E-Systems (US 5,845,255) + Pyxis (US 6,021,392) + Mitchell

• Coverage of claims 5 and 6, specifically. These are the strongest references on the page for the recordation and refill-control dependents:
  • Claim 5 (issuance and fulfillment recorded in the medium): Cunningham teaches dispensing, tracking and managing pharmaceutical products through a computer system; Advanced Health teaches a full prescription management workflow in which the prescription's fill is recorded; Pyxis teaches custody/administration tracking.
  • Claim 6 (refills authorizable only in response to information in the medium): this is the defining architectural feature of Cunningham/Pyxis-style restricted-dispensing systems, where the system, not the prescriber's paper, gates the refill. The Board used exactly this reference (Cunningham) in the sibling '720 IPR to supply an approval code issued prior to dispensing, confirming the Board's view that the art taught medium-conditioned release.
• Motivation. Same as above plus a strong economic/regulatory rationale: trial-product and controlled-substance dispensing systems existed precisely to prevent diversion and premature refill. A POSA seeking to prevent a teratogen from reaching a fetus via a second fill would predictably adopt the refill-lockout architecture already used to prevent other classes of drug-handling error. "If a technique has been used to improve one device, and a POSA would recognize that it would improve similar devices in the same way, using the technique is obvious" (KSR, quoted by Petitioner in the sibling record).
• Note on Celgene's construction argument. Celgene's § 103 defense on claims 5–6 was purely derivative: it argued the "computer readable storage medium" must be centralized and, therefore, that Dishman's decentralized system fell outside. The Board rejected that construction and held in the alternative that a centralized database was itself obvious (Paper 73 at 11, 20). Combination B therefore also defeats claims 5–6 under either construction — Advanced Health, Cunningham and Pyxis all contemplate a centralized prescription record. This is the belt-and-suspenders point: the claims are obvious regardless of how the medium is construed.

Combination C — Medscreen (US 5,299,121) + First Opinion (US 5,660,176) + Dishman (+ Mitchell for the teratogen content)

• Coverage. Medscreen supplies contraindication screening keyed to the individual (the "person for whom the drug is contraindicated" concept). First Opinion supplies a computerized determination of patient condition/treatment eligibility. Dishman supplies the registry/lockout. Mitchell supplies the teratogen-specific clinical steps.
• Why it matters — and a limitation. This combination maps well onto the specification's second, broader embodiment ("methods for delivering a potentially hazardous drug … while avoiding the delivery of said drug to persons for whom said drug is contraindicated"), but not onto the issued claims standing alone, because issued claim 1 is expressly limited to "a teratogenic drug." Combination C is therefore relevant to (i) the breadth of the disclosure, which is why the specification's broader embodiment never matured into an independent claim, and (ii) any continuation/divisional claim set, not to the '501 claims as issued. I flag this because it is an easy error to over-apply the "contraindicated individual" art to the issued claims.

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V. Claim-by-claim § 103 disposition

Net result: no claim of the '501 survives § 103. All ten claims were held unpatentable; rehearing was denied; the holding was affirmed. There is no surviving claim and no untested claim — the point the prior Strategic summary made, now with its § 103 predicate fully laid out.

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VI. Secondary considerations — what Celgene offered and why it failed

Because the prior sections did not analyze the objective-indicia record, expanding it here is materially useful (it is the only place a future litigant could realistically attack the FWD, and it is also the only place a hypothetical future challenge would have to operate, given that the claims are already cancelled):

The Federal Circuit found substantial evidence for each conclusion. The structural lesson: the closer the secondary consideration is to a mere aggregation of the prior art's known benefits, the less nexus it carries. S.T.E.P.S.® performing the function Mitchell and Dishman already performed is not an unexpected result.

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VII. Bottom line and practical implications

1. The § 103 case is over-determined. Claims 1–10 were held obvious over Powell + Mitchell + Dishman (a combination of three § 102(b) journal references), affirmed at 931 F.3d 1342, with rehearing and en banc review denied. Independently, the patent's own cited-art tables (Cunningham, Advanced Health, Pyxis, Base Ten, Lucent, Medscreen, First Opinion) supply the same systemic elements, so the outcome does not depend on any single reference surviving challenge.
2. No claim-level fallback exists. Unlike the sibling '720 (where claim 10 survived rehearing), nothing survived on the '501. Any infringement assertion on this patent is untenable; the correct response to a demand is a citation to Paper 73 and Celgene v. Peter, not an invalidity case.
3. The two claim-construction fights that could have mattered are moot. Both the "centralized vs. decentralized medium" and "counseling vs. providing contraception" issues were resolved against Celgene, and the first was resolved against it both ways (decentralized satisfies the claim; alternatively, a centralized database was obvious).
4. The one genuinely close question is claim 10. If the § 103 analysis is ever revisited, claim 10's "providing a contraceptive device or formulation" is the weakest link in the petition's evidence base — the '720 rehearing outcome shows the Board will police over-claiming where a petition asserts disclosure that the reference does not actually contain. That, however, is a hypothetical; it did not avail Celgene on the '501.

Open verification items (unchanged from prior sections, restated because they bear on any formal § 103 opinion): (a) the exact three-APJ panel of the '501 FWD; (b) whether the USPTO has issued a formal cancellation certificate for claims 1–10 following the 2019 mandate; (c) the disposition of cert petition No. 19-1074; (d) the publication date and § 102 status of the Thalomid Package Insert (used in the sibling '720 IPR but not relied on in the '501 FWD — I did not verify its date here). None of these alters the § 103 conclusion, but each should be confirmed against PTAB E2E / PatentCenter before being stated as fact in a filed paper.