US 8315886

I'll search for authoritative information on this specific patent number, including any 2026 Federal Circuit activity.

Let me look for the actual claim set and any 2026 Federal Circuit docket activity.

Let me pin down the actual claim set of the '886 patent and check for any 2026 CAFC docket entry.

US Patent 8,315,886 — Analyst Summary

Important flag first: I was able to verify the bibliographic data, abstract, prosecution family, and litigation/Orange Book history for this patent. However, I could not retrieve the verbatim text of the patent's actual claims in this session, and the authoritative full text supplied to me for this patent stops mid-sentence in the specification (in the isoniazid example) without a claims section. So the "independent claim" overview below is derived from the patent's own Abstract, its Summary-of-Invention passage, and the closely related parent patents — not from quoted claim language. Treat that portion as inferential, not verbatim.

1. Bibliographic data (verified)

Continuation chain (from the patent's own Cross-Reference section): 12/966,261 ← 11/437,551 (2006-05-19) ← 11/028,144 (2005-01-03, now US 7,141,018) ← 10/762,880 (2004-01-22, now US 6,869,399) ← 10/383,275 (2003-03-07, now US 6,755,784) ← 09/965,155 (2001-09-27, now US 6,561,977) ← 09/694,217 (2000-10-23, now US 6,315,720). Children: 13/591,622 (→ US 8,626,531) and 13/655,928 (→ US 2013/0046554 A1).

2. Abstract (verbatim)

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

3. Plain-language overview of the claims

Caveat on scope of this section. I do not have verified claim text for US 8,315,886. What follows is a plain-language reconstruction grounded in (a) the patent's own Abstract and Summary-of-Invention, and (b) the near-identical parent claim language reported in public PTAB litigation filings. If you need the operative claim language, pull the granted claims directly from USPTO PatentCenter/Global Dossier for 12/966,261.

Independent claim(s) — reconstructed subject matter. The patent is a method claim (a business/healthcare-workflow method, later classified under G16H). A representative independent claim in this family recites, in substance:

1. The setting / preamble: a method of delivering a drug to a patient in need of it while avoiding an adverse side effect known or suspected to be caused by the drug, of the type in which a prescription is filled only after a computer-readable storage medium has been consulted to confirm that (i) the prescriber is registered and qualified to prescribe, (ii) the pharmacy is registered and qualified to fill, and (iii) the patient is registered and approved to receive the drug.
2. Defining risk groups: defining a plurality of patient risk groups based on a predefined set of risk parameters for that drug.
3. Defining an information set: defining information to be obtained from the patient that is probative of the risk the side effect will occur if the drug is taken (e.g., age, sex, reproductive status, survey answers).
4. Assigning the patient: responsive to that information, assigning the patient to at least one risk group and entering the assignment into the medium.
5. Risk-acceptability determination: based on the information and the risk-group assignment, determining whether the risk of the adverse side effect is acceptable.
6. Approval code: upon a determination that the risk is acceptable, generating a prescription approval code to be retrieved by the pharmacy before the prescription is filled — the "pharmacy need only retrieve the approval code" concept the specification emphasizes.

Dependent claims in this family typically add limitations such as: the drug is thalidomide; the information set includes genetic testing results; periodic patient surveys (specification says monthly for female patients, every 3–6 months for male patients, preferably by IVR telephone system); diagnostic tests on bodily fluids/tissue; a risk group for strictly contraindicated patients who are not approved to receive the drug; and limited prescription quantities (no more than about 28 days, no refills).

Note on independent-claim count: the parent '720 patent had two independent claims (claim 1 and claim 28, 32 claims total). I cannot confirm from my sources how many independent claims the '886 patent has, or its total claim count. Do not cite a claim count for '886 without checking the granted claims.

4. Regulatory / Orange Book history

• Listed in the FDA Orange Book for Thalomid (thalidomide), NDA 020785, with patent use code U-1249, expiration 2020-10-23.
• Also appears in Orange Book listings tied to Pomalyst (pomalidomide, NDA 204026) with use code U-1361.
• It is one of ~14 "distribution method"/REMS patents Celgene listed around the S.T.E.P.S./RevAssist programs.

5. Litigation check — including CAFC 2026

No 2026 Federal Circuit docket activity for US 8,315,886 was found. My searches surfaced no CAFC 2026 appeal, opinion, or oral-argument entry involving this patent number. The 2026 Federal Circuit material returned was unrelated (e.g., Dolby v. Unified Patents cert petition; Enviro Tech v. Safe Foods, No. 2024-2160; TJTM v. Google, No. 2025-1218). A DrugPatentWatch litigation page for this patent, marked "Last Updated: April 7, 2026," lists district-court cases only (D.N.J., D. Minn., D.D.C.) through 2021 — again, no CAFC 2026 entry.

The closest actual appellate history in this family: Celgene did appeal PTAB decisions on the related '501 and '720 patents to the Federal Circuit in Nov. 2017 (see Celgene v. Peter, later the subject of Celgene's 2020 cert petition, No. 19-1074). That appeal concerned the '501/'720 patents, not the '886 patent. The '886 patent was instead attacked collaterally in antitrust/Walker-Process and sham-litigation complaints (D.N.J., D. Minn.).

Two hygiene notes on the litigation data:

• The DrugPatentWatch table includes an entry "8,315,886 | Duro Dyne National Corp. | 18-27963 (Bankr. D.N.J.)" — a sheet-metal/ductwork company's bankruptcy. This is almost certainly a data-matching artifact, not a case involving this patent.
• Google Patents lists several New Jersey District Court cases for the family (2:18-cv-11518, 2:17-cv-06842, 2:18-cv-13477, 2:18-cv-06378, 2:10-cv-05197, 2:15-cv-00697) via Unified Patents data, plus a Darts-IP "first worldwide family litigation" entry. These are family-level, not necessarily '886-specific.

6. Uncertainty summary

• High confidence: all bibliographic fields, title, assignee, inventors, dates, abstract, family chain, Orange Book/REMS context, absence of 2026 CAFC activity.
• Low/moderate confidence, verify before relying: the verbatim content and number of the '886 patent's independent claims; whether its independent claim includes the "generating a prescription approval code" limitation (the Abstract strongly implies it does); and the precise claim-count.
• The nominal expiry (2020-10-23) versus Google Patents' "adjusted expiration" (2021-03-27) differ; the discrepancy is likely term adjustment/pediatric exclusivity, but I have not verified which governs.

I'll research known litigation involving US patent 8315886. Let me run several targeted searches.

Good results. The Google Patents page for US8315886 itself lists several New Jersey District Court cases. Let me research those specific case numbers.

I've gathered substantial information, though I hit the tool-step limit before fully verifying every case number. Here's what I found, clearly separating confirmed facts from items I could not fully verify.

Patent context

US 8,315,886 ("the '886 patent") — "Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated" — inventors Bruce A. Williams and Joseph K. Kaminski, assignee Celgene Corporation. It is a "REMS"/drug-distribution-method patent in the same family as US 6,045,501; 6,315,720; 6,561,977; 6,755,784; 7,141,018, etc. (all sharing the Oct. 23, 2000 priority date). It covers the S.T.E.P.S./REMS restricted-distribution programs for Thalomid (thalidomide) and Revlimid (lenalidomide).

Known litigation

The Google Patents page for US8315886 itself lists (all District of New Jersey) the following case numbers: 2:10-cv-05197, 2:15-cv-00697, 2:17-cv-06842, 2:18-cv-06378, 2:18-cv-11518, 2:18-cv-13477.

Details worth noting

2:17-cv-06842 (Lotus/Alvogen) — the best-documented '886 case.

• Cause: 15:1126 Patent Infringement (ANDA). Assigned to Judge Susan D. Wigenton, Magistrate Leda Dunn Wettre.
• Patents-in-suit expressly included the '886 patent (along with 6,045,501; 6,315,720; 6,561,977; 6,755,784; 7,189,740; 7,465,800; 7,855,217; 7,968,569; 8,404,717; 8,530,498; 8,626,531; 8,648,095; 9,056,120; 9,101,621; 9,101,622).
• Lotus/Alvogen moved for judgment on the pleadings (Doc. 69, June 21, 2018) arguing the "REMS patents," including the '886 patent specifically, were invalid under 35 U.S.C. § 101 (Alice/abstract idea). Celgene opposed (Doc. 82, Sept. 7, 2018).
• On Feb. 22, 2019, the court entered a stipulation staying proceedings as to US 6,315,720; 6,561,977; 6,775,784; 8,315,886; and 8,626,531.
• On March 29, 2019, a consent judgment and injunction was entered; all claims, counterclaims, defenses dismissed with prejudice. The case was closed (terminated 2019-09-05 per DrugPatentWatch).

2:15-cv-00697 (Lannett). This is the Thalomid ANDA case. The complaint (rpxcorp/Celgene v. Lannett) states it arises from Lannett's ANDA seeking to market generic thalidomide capsules and lists the '886 patent as Exhibit M among patents-in-suit.

2:10-cv-05197 (Natco). The Revlimid ANDA case; '886 listed. A stipulation was filed March 26, 2015 under which Natco ceased its approval efforts (per the Providence complaint in 2:14-cv-06997).

Related (but distinct) matters in which the '886 patent appears

The '886 patent is also cited in Celgene antitrust litigation (the "REMS patents" theory), not as an infringement count:

• Humana Inc. v. Celgene Corp., 2:19-cv-07532 (D.N.J., Judge Esther Salas) — '886 listed among patents at issue.
• In re Revlimid and Thalomid Purchaser Antitrust Litigation (consolidated, 2:19-cv-07532) and related indirect-purchaser/end-payor actions (e.g., 2:14-cv-06997; 2:17-cv-04319) alleging Celgene fraudulently obtained the "REMS patents" and used them in sham litigation. These are antitrust, not patent-infringement, cases.

Important caveats

• Not fully verified: For 2:18-cv-06378, 2:18-cv-11518, and 2:18-cv-13477 I confirmed the case numbers exist in the D.N.J. and are tied to this patent per the Google Patents family-litigation listing, but I could not retrieve the specific plaintiff/defendant designations, filing dates, or outcomes for each before exhausting my search steps. I'd treat those three rows as provisional. (18-11518 appears connected to the Lotus/Alvogen judgment.)
• Lannett outcome unconfirmed. I did not confirm how 2:15-cv-00697 terminated.
• Source basis: The case list originates from the Google Patents litigation panel for US8315886 (portal.unifiedpatents.com entries) plus DrugPatentWatch, CourtListener/RECAP, and the NPE/Stanford litigation database. I could not independently open the Unified Patents case-list page itself.
• I did not auto-correct any patent or case identifiers; all numbers are reported as found.

If you want, I can (on a fresh request) drill into 2:18-cv-06378, 2:18-cv-11518, 2:18-cv-13477, and the Lannett outcome specifically to fill those gaps.

I'll verify the structured-data starting point ("no AIA proceedings on file") against public sources before writing anything up.

Let me specifically check whether any AIA petition ever targeted the '886 patent, and confirm the identity of the IPRs that hit the related '501/'720 patents (so I don't conflate them).

Confirming the absence with two more targeted checks — the '886 patent's own PTAB tab and any CBM activity against Celgene's REMS patents.

AIA Trial Proceedings — US 8,315,886 (Celgene, "REMS"/drug-distribution family)

Bottom line up front: there are no AIA trial proceedings on US 8,315,886. The structured "PTAB proceedings on file" block (USPTO Open Data Portal ingest) returns zero proceedings for this patent number, and my independent verification against Celgene's own SEC disclosures, DrugPatentWatch's Celgene-as-patent-owner PTAB table, and the Board's own "Related Proceedings" recitals in the sibling-patent Final Written Decisions is consistent with that. I found no IPR, PGR, or CBM naming US 8,315,886 as the challenged patent. The absence is, in this particular family, itself the most important analytical fact — and it needs to be read alongside the proceedings that hit the sibling patents, which are frequently conflated with the '886 in secondary sources.

Proceedings overview

Total AIA trial proceedings on US 8,315,886: 0 — no active proceedings, no claims invalidated, no claims sustained, no settlements, no institution denials, because no petition was ever instituted (and, on the public record I could retrieve, none was ever filed).

The bottom-line defensive posture is therefore not "the patent survived IPRs and is hardened." It is closer to the opposite: US 8,315,886 never had its claims tested at the PTAB at all, its two closest sibling patents in the same family ('501 and '720) were invalidated at the Board, and the patent has since expired. A defendant today holding a demand or complaint citing the '886 cannot lean on PTAB estoppel (none exists), but likewise faces a patent whose claimed subject matter, closely-analogous siblings, and equity story have all been badly damaged in other fora — at the Board, in district court § 101 motion practice, and in a wave of Walker Process / inequitable-conduct antitrust complaints.

Per-proceeding entries

None. There are no proceeding numbers to report on US 8,315,886, and I will not fabricate any.

Two things I verified in lieu of a proceeding list, because they are the checks that would have surfaced a missed '886 petition:

1. Celgene's own disclosures enumerate the REMS IPRs and omit the '886. Celgene's 10-K/10-Q USPTO-proceedings notes from 2015 through 2018 state that on 2015-04-23 the Coalition for Affordable Drugs VI LLC ("CFAD VI") filed IPR petitions challenging U.S. 6,045,501 (the '501) and U.S. 6,315,720 (the '720) — and only those two — "covering certain aspects of our REMS program," with institution on 2015-10-27. The filings then expressly say Celgene "retain[s] other patents covering certain aspects of our REMS program" — the '886 is in that residual bucket, not in the challenged bucket. A company discloses adverse PTAB proceedings against its Orange Book patents; it disclosed only two.
2. The Board's own related-proceedings recitals never list an '886 trial. In every '720 Final Written Decision (IPR2015-01096, -01102, -01103), the Board's section A lists the related judicial matters and states that "the claims of the '720 patent have been challenged in two related inter partes review proceedings, IPR2015-01102 and IPR2015-01103" (and, in the -01102/-01103 decisions, IPR2015-01096). No '886 proceeding appears.

Why this is unsurprising (not just a gap in indexing). The '886 patent issued 2012-11-20 from an application filed 2010-12-13, as a late continuation in the family — i.e., after the ANDA suits that the CFAD campaign was launched against. The CFAD challenge mapped to the '501 (the original S.T.E.P.S. patent) and the '720 (the "Enhanced S.T.E.P.S." improvement patent). It did not reach the later-filed continuations ('886 and its sibling '531). Had CFAD wanted the whole family dead, the '886 was the obvious next petition; it never came.

The adjacent proceedings that actually matter to a '886 defendant

These are proceedings on other patents, not on US 8,315,886. I include them because they are routinely (and wrongly) reported as "IPRs against the Celgene REMS patents" without distinguishing which patent, and because they are the source of the family-wide invalidity story a defendant would actually use.

IPR2015-01092 — Coalition for Affordable Drugs VI LLC v. Celgene Corp. (U.S. 6,045,501, the '501)

• Type: Inter Partes Review
• Filed: 2015-04-23
• Status: Claims canceled — Final Written Decision holding claims 1–10 unpatentable; rehearing denied (2017-09-08); Federal Circuit appeal filed by Celgene 2017-11-09.
• Judge panel: Michael P. Tierney, Grace Karaffa Obermann, Tina E. Hulse (per the '720 decisions; the '501 panel was the same substantive panel across the campaign).
• Petition grounds: § 103 obviousness across all ten claims, on a single instituted ground — Powell in view of Mitchell and Dishman.
• Institution decision: Instituted 2015-10-27 on claims 1–10 (Paper 20).
• Final Written Decision: Issued 2016-10-26 (Paper 73); Board held CFAD showed by a preponderance that claims 1–10 are unpatentable as obvious over Powell + Mitchell + Dishman.
• Settlement / termination: None — litigated to FWD.
• Appeal: Celgene appealed to the Federal Circuit (2017-11-09); the USPTO intervened (2018-02-26). The '501 appeal was consolidated with the '720 appeal and decided in Celgene Corp. v. Peter, reported at 931 F.3d 1342 (Fed. Cir. 2019), affirming the Board. Celgene's cert petition was No. 19-1074 (filed 2020-02-26).
• Defensive value for a '886 defendant: zero estoppel effect on '886, but high persuasive value — the '501 is the foundation patent from which the '886's specification descends almost verbatim, and the Powell/Mitchell/Dishman art that killed it is the natural starting art for an invalidity attack on the '886 claims.

IPR2015-01096 / IPR2015-01102 / IPR2015-01103 — Coalition for Affordable Drugs VI LLC v. Celgene Corp. (U.S. 6,315,720, the '720)

• Type: Inter Partes Review (three parallel petitions on the same patent)
• Filed: 2015-04-23 (all three)
• Status: Claims substantially canceled — claims 1–32 held unpatentable, then claim 10 resurrected on rehearing; appeal filed by Celgene 2017-11-06; affirmed on appeal.
• Judge panel: Michael P. Tierney (Vice Chief), Grace Karaffa Obermann, Tina E. Hulse.
• Petition grounds (§ 103, all claims 1–32):
• -01096: obviousness over the Thalomid Package Insert, Cunningham, Zeldis, and other art.
• -01102: obviousness over Powell and Dishman in view of Cunningham, further in view of Mann and other art.
• -01103: same as -01102 but using Mitchell instead of Powell as the base reference.
• Institution decision: Instituted on 2015-10-27 as to claims 1–32 in all three cases.
• Final Written Decisions: 2016-10-26 — -01096 Paper 73, -01102 Paper 75, -01103 Paper 76. Verdict: claims 1–32 unpatentable in each, on the instituted ground.
• Rehearing: Celgene moved on 2016-11-25. On 2017-09-08 the Board denied rehearing as to the '501 but granted it as to the '720, solely for claim 10 — holding claim 10 (which depends from claim 7, which depends from claim 1, and adds "said diagnostic testing comprises genetic testing") not shown unpatentable. The decision expressly states it "does not disturb our holding… that claims 1–9 and 11–32 are unpatentable."
• Settlement / termination: None — litigated to FWD.
• Appeal: Federal Circuit appeal filed by Celgene 2017-11-06, consolidated with the '501 appeal, decided in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) (affirmed); cert petition No. 19-1074. I did not independently confirm the cert disposition this session — treat that as unverified.
• Defensive value for a '886 defendant: the single most useful piece of ammunition in the family. The '720 is the same specification, same Jepson-style independent claims, same "risk group + approval code" architecture as the '886 (two independent claims, 1 and 28, per the Board's "Illustrative Claims" discussion). The Board's Powell/Mitchell/Dishman/Cunningham analysis is directly transferable prior art against the '886 claims, and it is not § 315(e)-estopped against any party as to '886.

Strategic summary

Canceled vs. sustained vs. untested, at patent granularity. No claim of US 8,315,886 is canceled, sustained, or otherwise adjudicated at the PTAB — the entire claim set is untested before the Board. What was canceled in the family: all ten claims of the '501 ('501 FWD, 2016-10-26, rehearing denied 2017-09-08) and claims 1–9 and 11–32 of the '720 (FWDs 2016-10-26, modified on rehearing 2017-09-08). One claim survives in the entire PTAB-tested REMS line: claim 10 of the '720, and only because the Board found the preponderance record did not reach its "genetic testing" limitation. The '886's own claims have drawn no PTAB treatment. The closest a court came to a merits validity ruling on the '886 was Celgene Corp. v. Lotus Pharmaceutical Co. / Alvogen Pine Brook, LLC, 2:17-cv-06842 (D.N.J.), where the defendants moved for judgment on the pleadings that the REMS patents — the '886 expressly included (Count IX) — were invalid under Alice / § 101; on 2018-12-14 Judge Wigenton denied the motion without prejudice as premature, because claim-construction disputes over "computer readable storage medium" and "generator configured to generate a prescription approval code" had to be resolved first. That is a non-ruling, and it is the high-water mark of '886-specific validity adjudication.

Estoppel landscape. Because there has been no IPR on '886, no § 315(e)(2) estoppel attaches to any ground as to '886, and there is no § 315(b) one-year bar keyed to this patent that a defendant would need to worry about having blown. Conversely, no petitioner estoppel helps Celgene either. The only estoppel in the family runs against CFAD VI and its real parties-in-interest/privies as to the '501 and '720 (§ 315(e)(1)) — which is why a later challenger would not be able to simply re-run the Powell/Mitchell/Dishman combination against those two patents, but can run it against the '886. Practically: for a '886 defendant, the prior-art grounds in IPR2015-01092/-01096/-01102/-01103 are all still available, and the Board's reasoning on materially identical claims is on the public record as an advocacy asset. The counterweight is a procedural one: the '886 is expired (Orange Book nominal expiry 2020-10-23; Google Patents shows an "adjusted expiration" of 2021-03-27 — see caveat below), so a prospective infringement theory has no runway and damages under § 286 are confined to the look-back window. An IPR of an expired claim set is legally available but usually costs more than it is worth.

Pattern signals. One petitioner, one campaign: Coalition for Affordable Drugs VI LLC — the hedge-fund-funded serial filer associated with Kyle Bass — filed against exactly two Celgene REMS patents on the same day (2015-04-23) and never extended to the '886 or its sibling '531. No defensive aggregator (Unified Patents, RPX) appears in the chain for this patent; the litigations involving '886 are ANDA/Paragraph IV suits brought by Celgene (Lannett 2:15-cv-00697, Lotus/Alvogen 2:17-cv-06842, Hikma 2:18-cv-13477, Natco 2:10-cv-05197) plus antitrust/Walker Process actions against Celgene (e.g., 2:19-cv-07532 Humana/Insurer plaintiffs; Walgreen 2:22-cv-06440; the 2025 Cigna and 2026 BMS complaints). In the antitrust complaints the '886 is pleaded as unenforceable — fraudulently procured and "not sufficiently distinct from the unenforceable '720," i.e., infectious unenforceability — and as invalid under § 101 post-Alice. Celgene's appellate posture in this family was defensive and vigorous (appeals of both FWDs, USPTO intervention, cert petition), so a future challenger should expect a well-funded patent owner.

Recommended next steps

• No PTAB activity exists on US 8,315,886 — say so plainly and stop looking for an FWD. The absence is a signal, but in this family it points at claim-scope and enforceability rather than at a cancellation judgment.
• Mine the sibling FWDs, not a hypothetical '886 FWD. Pull IPR2015-01096 Paper 73, IPR2015-01102 Paper 75 and IPR2015-01103 Paper 76 (all 2016-10-26) and the 2017-09-08 rehearing decision, plus IPR2015-01092 Paper 73 for the '501. These are the operative invalidating analyses for a specification the '886 shares, and the Board's Powell / Mitchell / Dishman / Cunningham / Thalomid Package Insert reasoning is the template for a § 103 attack on the '886 claims. Copies of the '601/'720 FWDs and the rehearing decision are reproduced in the Celgene Corp. v. Peter cert appendix (No. 19-1074).
• Check expiry and the live target before spending money. Confirm the operative expiry (Orange Book 2020-10-23 vs. Google Patents' adjusted 2021-03-27) in PatentCenter/Global Dossier. If the '886 is expired, the commercially live sibling is likely US 8,626,531 (the '531) — same title, same family, same nominal expiry, and also named alongside the '886 in the Lotus/Alvogen § 101 motion (Count XII). Verify the '531's status independently; do not assume symmetry with the '886.
• Preserve the § 101 and inequitable-conduct vectors, because the PTAB vector is closed. The Lotus/Alvogen Alice motion was denied without prejudice as premature (2018-12-14) precisely because claim construction had not happened — that door is not shut, and the antitrust complaints supply a ready-made inequitable-conduct/infectious-unenforceability theory (alleged non-disclosure of the PPP Package and the CDC Transcript during the '886's prosecution). If you are drafting a defense today, that is the heavier artillery; an IPR on an expired patent is the lighter one.

Verification log and uncertainty (read before relying)

• High confidence: zero AIA trial proceedings on US 8,315,886. Corroborated three ways — the structured ODP block in this prompt; Celgene's 10-K/10-Q USPTO-proceedings disclosures (2015–2018) naming only the '501 and '720; and the Board's own related-proceedings recitals. No CBM or PGR on '886 appeared in any source, and none is expected: the '886 has a 2000-10-23 effective filing date, so PGR was unavailable (post-3/16/2013 filings only); CBM would have been the only AIA vehicle, and none was filed (the CBM program sunset 2020-09-16).
• Moderate confidence, verify if it matters: the exact Federal Circuit citation and disposition in Celgene Corp. v. Peter (931 F.3d 1342 (Fed. Cir. 2019), affirmed; mandate reflected as 2019-12-09/16 in the cert appendix) and the disposition of cert petition No. 19-1074. I confirmed the affirmance and the 2019 mandate from the cert-petition appendix text but did not pull the opinion or the cert docket this session.
• Explicitly not verified this session: the '886 patent's verbatim granted claims and independent-claim count (consistent with the caveat already flagged in the earlier Patent-summary section of this analysis — the supplied full text stops mid-specification at the isoniazid example and contains no claims section). Any statement above about the '886's claim architecture is inferential from the Abstract, the Summary of Invention, and the sibling '720 claims as recited in the '720 FWD.
• Expiry discrepancy flagged, not resolved: nominal 2020-10-23 (Orange Book) vs. 2021-03-27 "adjusted expiration" (Google Patents). I did not determine which governs, and it matters to any damages or IPR cost/benefit analysis.
• Identifiers reported as found; nothing auto-corrected. Note the recurring transcription hazard in this family: the '886 is frequently written as '866/8,351,886 and the '976/'977 patents are routinely transposed in the secondary literature. All proceeding numbers above (IPR2015-01092, -01096, -01102, -01103) are reproduced exactly as they appear in the Board's decisions and Celgene's disclosures.

Sources

• Structured input: "PTAB proceedings on file" block (USPTO Open Data Portal ingest) — null result for US 8,315,886.
• Board Final Written Decisions and rehearing decision: IPR2015-01092 Paper 73; IPR2015-01096 Paper 73; IPR2015-01102 Paper 75; IPR2015-01103 Paper 76 (all 2016-10-26); rehearing decision 2017-09-08 — reproduced in the appendix to Celgene Corp. v. Peter, No. 19-1074 (U.S.), https://www.supremecourt.gov/DocketPDF/19/19-1074/[134252](/patent/134252)/20200226155847157_Celgene%20Corp.%20v.%20Peter%20-%20Cert%20Petition%20-%20Appendix.pdf
• USPTO PTAB End-to-End / PTAB Decisions portal: https://ptacts.uspto.gov/ptacts/
• Celgene Corp. v. Lotus Pharmaceutical Co., Ltd. / Alvogen Pine Brook, LLC, No. 2:17-cv-06842 (D.N.J. Dec. 14, 2018) (§ 101 motion including the '886, Count IX, denied without prejudice), https://cases.justia.com/federal/district-courts/new-jersey/njdce/2:2017cv06842/[354127](/patent/354127)/90/0.pdf
• D.N.J. filing collecting the four CFAD FWDs, https://storage.courtlistener.com/recap/gov.uscourts.njd.[503932](/patent/503932)/gov.uscourts.njd.503932.60.0.pdf
• Celgene Corp. Form 10-K/10-Q USPTO-proceedings disclosures (2015–2018), e.g., https://capedge.com/filing/[816284](/patent/816284)/0000816284-18-000005/CELG-10K-2017FY and https://capedge.com/filing/816284/0000816284-17-000014/CELG-10Q-2017Q3
• DrugPatentWatch PTAB tables — Patent Owner: Celgene Corporation, https://www.drugpatentwatch.com/p/litigation/ptab-patent-owner/index.php?query=Celgene+Corporation; THALIDOMIDE PTAB cases, https://www.drugpatentwatch.com/p/litigation/drugname/index.php?query=THALIDOMIDE (both list '501 and '720, and ABRAXANE patents — no '886 entry)
• Antitrust pleadings naming the '886 as fraudulently procured / unenforceable and pressing Alice: https://storage.courtlistener.com/recap/gov.uscourts.njd.[399896](/patent/399896)/gov.uscourts.njd.399896.1.0.pdf; https://storage.courtlistener.com/recap/gov.uscourts.mnd.[190088](/patent/190088)/gov.uscourts.mnd.190088.1.1.pdf; http://business.cch.com/ald/InreRevlimidandThalomidPurchaserAntitrustLitigation672024.pdf

One cross-reference note against the earlier-generated sections of this analysis (no contradiction, but a refinement): the Litigation-summary section correctly reported that 2:17-cv-06842 is "the best-documented '886 case," and that the '886 was among the patents stayed and then dismissed with prejudice there. The PTAB question is now closed in the opposite direction — the '886 was pleaded and briefed in that case but never petitioned at the Board. Any downstream summary that says the "Celgene REMS patents were invalidated by the PTAB, including the '886" is wrong and should be corrected to: the '501 and '720 were invalidated (with '720 claim 10 surviving), and the '886 was not.

I'll research the assignment record for US 8,315,886, focusing on USPTO Assignment Center data and any ownership changes.

The searches returned assignment data for unrelated patents. Let me target the '886 patent's own assignment record and the inventor-to-Celgene assignment.

I found the key inventor→Celgene assignment reference (Reel 11469, Frame 882 for the '720 parent). Let me verify whether the '886 patent has its own distinct recorded assignment and check Google Patents legal events.

I have enough to reconstruct the ownership record. Note a hard limitation up front: my search steps were exhausted before I could render the USPTO Assignment Center page for application 12/966,261 directly, so I could not enumerate reel/frame entries that exist solely at the granted-patent level. What follows distinguishes verified recordations from inferential coverage.

Inventors

Both inventors are named on the entire family (the '720/'977/'784/'399/'018/'566/'886 line). This is a two-inventor, single-employer family — there is no cross-company inventorship, no co-ownership, and no evidence of either inventor departing Celgene within 12 months of the Oct. 2000 filing. Williams remained a Celgene-affiliated author of record on later thalidomide/lenalidomide safety literature (e.g., Bwire et al., cited as IPR Exhibit 1083), consistent with continued employment rather than a founding-team walk-out. No fire-sale precursor pattern.

Original assignee

Celgene Corporation — a Delaware corporation; address on the assignment deed of record is 7 Powder Horn Drive, Warren, New Jersey 07059; later correspondence address 86 Morris Avenue, Summit, New Jersey 07901.

• Primary line of business: branded pharmaceutical discovery/development/commercialization (thalidomide, lenalidomide, pomalidomide, etc.).
• Shipped a product embodying the claims: Yes. US 8,315,886 is listed in the FDA Orange Book for Thalomid (thalidomide, NDA 020785, use code U-1249, expiry 2020-10-23) and for Pomalyst (pomalidomide, NDA 204026, use code U-1361). The claimed subject matter is the S.T.E.P.S./RevAssist restricted-distribution (REMS) workflow that Celgene actually operated to ship thalidomide and lenalidomide. This is a product-tied process patent, not a paper asset.
• Current status: Operating, but no longer independent. Celgene was acquired by Bristol-Myers Squibb in a cash-and-stock merger that closed November 20, 2019 (announced Jan. 2019). Celgene now operates as a wholly-owned BMS subsidiary. Google Patents still lists "Celgene Corp" as current assignee because no patent-level change-of-name/merger recordation may have been made — see the timeline caveat below.
• Patent status: Expired – Fee Related, adjusted expiration 2021-03-27 (Orange Book nominal expiry 2020-10-23). The asset is dead; there is no live assertion market for it.

Assignment timeline

Important limitation. USPTO Assignment Center / assignment.uspto.gov indexes the property by application number. I attempted to pull the abstract of title for application 12/966,261 and for patent 8,315,886 but could not complete a direct retrieval before exhausting my search budget. The one recordation I verified in primary documents is the ancestral inventor→Celgene deed, which by its own terms covers this continuation. I am therefore reporting:

1. 2000-10-23 / recorded 2001-01-05 — Reel 11469 / Frame 0882

   • Conveyance: Assignment of Assignors' Interest
   • Assignor: Bruce A. Williams and Joseph K. Kaminski (joint inventors)
   • Assignee: Celgene Corporation, 7 Powder Horn Drive, Warren, NJ 07059
   • Correspondent: not captured — the recordation notice did not surface the filing attorney/firm in the sources I could open. (Flag: this is the one field the task most wants and the one I could not verify. A single appearance would not be a finding anyway; there is no recurrence to test.)
   • Context: Initial inventor assignment — the founders' rights conveyed to their employer, Celgene. Verified via Celgene's mandatory notice in IPR2015-01103 ("Celgene owns by assignment the entire right, title, and interest in U.S. Patent No. 6,315,720 … recorded … January 5, 2001, at Reel 11469, Frame 882") and a CourtListener exhibit (D.N.J. 2:17-cv-03387, Doc. 250-30) reproducing the Williams/Kaminski→Celgene deed referencing Serial No. 09/694,217.
   • Coverage note: the deed assigns "the entire right, title and interest … in and to any and all inventions … and all applications therefor," in the standard form that expressly reaches continuations, divisions and reissues. US 8,315,886 (app. 12/966,261) is a continuation in the direct 09/694,217 chain, so this single recordation presumptively supplies Celgene's title to the '886 patent without a separate '886-specific reel/frame.

2. 2010-12-13 — (recordation of the continuation itself, if any)

   • I did not find a distinct Assignment Center entry tied to 12/966,261's own filing. A continuation of an already-assigned family generally needs no new assignment; the recorders normally rely on the parent's reel/frame. Treat a separate '886 entry as unconfirmed.

3. Post-issuance (2012 → 2021): no post-issuance assignment found. Google Patents' legal-events panel for US 8,315,886 shows prosecution/publication/grant events and the 2021 "adjusted expiration," but no assignment event after grant. There is likewise no recorded transfer to any LLC, no security agreement, and no release.

4. 2019-11-20 — Celgene / Bristol-Myers Squibb merger (ownership by operation; recordation unverified). BMS acquired Celgene. The '886 patent passed to BMS as successor by operation of the merger, but I found no patent-level assignment recordation reflecting this on the '886 patent. If none was filed, USPTO records will continue to name Celgene Corporation — which is exactly what Google Patents shows. Flag this as a records gap, not a transfer.

Family-wide check: I found no recorded assignment for the '886 patent to any entity other than Celgene, and none to the IPNav/Kyle-Bass "Coalition for Affordable Drugs," Acacia, Marathon, or any other asserter. (See red-herring note below.)

Timeline diagram

timeline
    title Ownership of US 8315886
    2000 : Filed by inventors Williams and Kaminski
    2001 : Inventors assign to Celgene
         : Recorded Reel 11469 Frame 0882
    2010 : Continuation filed App 12966261
    2012 : Patent issues to Celgene Corp
    2015 : Asserted v Lannett and Natco
    2017 : Asserted v Lotus Alvogen
    2019 : Celgene acquired by Bristol Myers Squibb
    2021 : Patent expires fee related

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only recorded assignee in the chain is Celgene Corporation, a large branded-pharma operating company, at Reel 11469/0882. There is no LLC with an "IP / Holdings / Ventures" suffix, no registered-agent address, and no single-purpose entity anywhere in the title.

2. Known asserter in the chain — not present. No assignee in the chain matches Acacia, Marathon, Intellectual Ventures, Wi-LAN, Conversant, Vringo, Pendrell, Round Rock, et al. Important red herring to defuse: the searchable artifact connecting this patent to IPNav/Erich Spangenberg (PTAB IPR2015-01103 Exhibit 2041, "January 2014 Spangenberg/IPNav patent family tree") is a document IPNav's side produced as evidence — the petitioner in that IPR was Kyle Bass's Coalition for Affordable Drugs VI LLC, an adversary attacking Celgene's patents. IPNav never held title to the '886 patent. Do not read that exhibit as an assignee link.

3. Repeat correspondent across the chain — unclear / not established. Only one recordation (11469/0882) is verified, and its correspondent field did not surface in the accessible sources. With a single data point there is no recurrence to measure, and a lone appearance is not a finding. (This is the signal I could not close; a fresh Assignment Center pull of 12/966,261 and the parent reels would settle it.)

4. Cascading transfers — not present. No consecutive transfers through chained entities; the chain is one assignment (inventors→Celgene), then a corporate merger by operation of law.

5. Pre-litigation transfer — not present. The first suit naming the patent (Celgene v. Natco, 2:10-cv-05197, filed 2010) predates the '886 patent's own 2010 filing/2012 grant, and the patent was asserted by its long-time owner, not by a recently-assigned plaintiff. No venue-engineering transfer.

6. Bankruptcy fire-sale — not present. Neither Celgene nor BMS filed bankruptcy. (Caution: a DrugPatentWatch row reading "8,315,886 | Duro Dyne National Corp. | 18-27963 (Bankr. D.N.J.)" surfaced in the prior section's research — that is a data-matching artifact attaching this patent number to an unrelated sheet-metal company's Chapter case. Do not treat it as an assignment.)

7. Privateering — not present. Celgene asserted the family itself against generic filers (Natco, Lannett, Lotus/Alvogen, Hetero, Sun). No third-party NPE was enlisted to assert on Celgene's behalf. (The antitrust plaintiffs in the Revlimid/Thalomid litigation allege the opposite theory — that Celgene over-enforced its own Orange Book patents — which is an operating-company conduct theory, not privateering.)

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN.

Counter-signal worth surfacing (inverse of an NPE tell): this patent sits in the crosshairs of an NPE-style attack, not in the hands of one. Bass's Coalition for Affordable Drugs filed IPRs against the family, and the '501 and '720 parents were held unenforceable by the PTAB in 2016. Being the target of NPE-funded IPRs is the opposite of being an NPE asset.

Verdict

Operating-company assertion.

The chain runs inventors Williams and Kaminski → Celgene Corporation, recorded 2001-01-05 at Reel 11469/0882, with the '886 patent covered as a continuation in that family and no subsequent assignment to any other entity. Celgene (now a Bristol-Myers Squibb subsidiary) is a product-shipping operating company that commercialized the patented REMS workflow in Thalomid and Pomalyst, and it asserted the patent against actual generic competitors (Natco 2:10-cv-05197; Lannett 2:15-cv-00697; Lotus/Alvogen 2:17-cv-06842). Every NPE tell — shell LLC, asserter assignee, cascading transfers, pre-suit transfer, fire-sale — is absent. The absence of any NPE link is itself notable given the patent was repeatedly targeted by an NPE-side petitioner.

Two record gaps to close before relying on this: (a) the correspondent of record on Reel 11469/0882, and (b) whether any '886-specific or BMS-merger recordation exists. Verify at the USPTO Assignment Center:
https://assignmentcenter.uspto.gov/ (search application 12/966,261) and https://assignment.uspto.gov/patent/index.html.

I have not auto-corrected any patent, application, reel/frame, or case identifier; all are reported as found, and the single reel/frame I assert (11469/0882) is corroborated by Celgene's own IPR2015-01103 mandatory notice.

I'll research the prior art citations for US 8,315,886, starting with targeted searches for the patent's front-page references.

Good leads. Let me dig into the actual front-page "References Cited" list for the '886 patent, including the U.S. patent documents and non-patent literature.

Excellent — I now have the actual claim set. Let me now retrieve the front-page "References Cited" list for the '886 patent, including the IDS filed in application 12/966,261.

I hit the tool-step ceiling before I could open USPTO PatentCenter directly, but I retrieved enough authoritative material to answer. Here's the prior-art analysis, with clear separation between verified facts and items needing confirmation.

Prior art analysis — US 8,315,886 (Celgene / Williams & Kaminski)

0. Two important corrections to earlier sections

Before the prior art, I have to flag a contradiction with the previously generated summary, because it materially changes the § 102 analysis:

1. The earlier section said the verbatim claim text could not be retrieved and reconstructed claim 1 as a "defining risk groups / assigning the patient to a risk group" method. I have now located the actual granted claims (via DigitalPatentWatch's patent-claims page for 8,315,886, corroborated on a second DrugPatentWatch page). The real claim 1 does not recite risk groups at all. It is a male-patient method. The earlier reconstruction was wrong and should be discarded. See § 1.

2. No 2026 Federal Circuit activity was confirmed, consistent with the earlier section — nothing in the new searches changes that.

1. USPTO-record lookup of 8315886 (verified; do not conflate with neighbors)

Per the Google Patents record (a USPTO mirror) and DrugPatentWatch:

The actual granted claims (this is the target of the § 102 analysis)

Claim 1 (independent): "A method of treating a male patient having a disease or condition responsive to a teratogenic drug, comprising permitting prescriptions for the drug to be filled by a pharmacy only after the pharmacy has retrieved an approval code for the prescription, wherein generation of the approval code comprises:

• (a) via a computer readable storage medium, registering a prescriber and the pharmacy with a distributor of the teratogenic drug;
• (b) determining whether the patient is able to understand and carry out instructions;
• (c) upon that determination, providing verbal and written warnings of the hazard of taking the drug and exposing a fetus;
• (d) further providing verbal and written warnings of the risk of possible contraception failure and of the need to use barrier contraception with women of child-bearing potential;
• (e) obtaining acknowledgement of said warnings from the patient;
• (f) via a computer readable storage medium, registering the patient with the distributor; and
• (g) upon obtaining the acknowledgement and registrations, generating the prescription approval code to be retrieved by the pharmacy; and
• (h) upon retrieving the approval code, **administering the drug to the patient."

Dependent claims: 2 (menu of acknowledgement items), 3 (non-teratogenic side-effect warnings), 4 (written prescriber authorization), 5 (approval code retrieved from a medium), 6 (acknowledgement = written informed consent), 7 (informed consent registered before code generation).

This is a genuine correction: the earlier "reconstructed" independent claim (risk-group definition → assignment → acceptability determination → approval code) is not claim 1 of the '886 patent. Anyone relying on the earlier section should switch to the claim text above.

2. The controlling § 102 framework (why the date matters so much here)

The '886 patent has a 2000-10-23 priority date, so pre-AIA § 102 governs. Its claims are only entitled to that date if the 2010-filed male-patient claims are supported by the 2000 disclosure. That creates a fork that dominates the prior-art analysis:

• If the claims get 2000-10-23 → a reference printed/published after 2000-10-23 is not § 102(a)/(b) art, and (same-inventor/same-owner excepted) not § 102(e) art either.
• If the claims only get the later continuation filing (2006 or 2010) → post-2000 references with earlier filing dates can come in as § 102(e) art.

This fork matters because, as shown below, the most-cited patent publications on the '886 record (the Reardan publications) were published in 2005 — after the 2000 priority date. On their face they look like citations, but they can only anticipate if the claims lose the 2000 priority. Flag this if the claims are ever tested.

3. References cited on / for the '886 patent

I was able to retrieve the '886 front-page "References Cited" content only in part (via CourtListener PDFs of the patent as filed in D.N.J. complaints, and a PTAB exhibit consisting of the IDS for Application 12/966,261). The table below lists what I could actually verify. I have not auto-corrected any number.

A. Patent references

B. Non-patent literature (the strongest § 102(b) art)

These appear in the '886 "Other Publications" list and are all pre-dating 1999-10-23, so they are § 102(b) art (the same class of art the PTAB relied on to invalidate the sibling '501 and '720 patents):

4. Bottom line — most relevant prior art

1. US 6,045,501 (Elsayed et al.) — the single most material reference. It is the closest thing to a § 102 anticipation of the registration/approval-code core of claim 1, and it is expressly acknowledged in the '886 specification, which frames the invention as an improvement on it. § 102(a)/(e). Likely missing: the male-patient framing and the barrier-contraception/contraception-failure warnings of claim 1(c)–(d), so anticipate of claim 1 is possible but not clean.
2. The Clozaril program documents (1989–1998) — the strongest § 102(b) art, and the exact art that took down the sibling '501/'720 patents at the PTAB. Best directed at the gated-distribution/registration architecture (claim 1(a),(f),(g); claims 4–7), not at the teratogen-specific counseling.
3. US 2005/0090425 A1, 2005/0216309 A1, 2005/0222874 A1 (Reardan et al.) — relevant only as § 102(e) art and only if the '886 claims are denied the 2000-10-23 priority date. Because they published in 2005, they cannot be § 102(a)/(b) art against 2000-priority claims. This is the key vulnerability question for this patent.
4. US 5,299,121 (Brill et al.) — § 102(b) dispensing-system art; peripheral.

No single reference I located squarely discloses every limitation of claim 1 (specifically the conjunction of a male patient, teratogenic drug, contraception-failure and barrier-contraception written warnings, acknowledgement, and an approval-code-gated dispense). That makes the most likely validity challenge an obviousness (§ 103) combination (e.g., Elsayed/'501 or Clozaril + Reardan), which is exactly how the PTAB treated the '501/'720 parents — rather than clean § 102 anticipation.

5. What I could not verify (do not treat as established)

• I did not open USPTO PatentCenter / the '886 prosecution file directly. The reference list above comes from Google Patents, DrugPatentWatch, and CourtListener PDFs of the patent itself, plus a PTAB exhibit identified as the IDS for Application 12/966,261. The full front-page "References Cited" list is therefore incomplete here.
• US 5,299,121 (Brill et al.) — I saw it adjacent to the Reardan publications in a document that carries the '886 abstract, but I did not open the document to confirm its title/subject. Verify before citing.
• US 5,704,153 (Kaminski et al., 1998-01) surfaced in one search next to a "(56) References Cited" heading, but that hit came from an unrelated Indiana case and the inventor surname ("Kaminski") may be a coincidental match. Treat as an unverified/possible artifact — not confirmed as a '886 citation. (No auto-correction applied.)
• Whether the '886 claims are entitled to the 2000-10-23 priority date is the pivotal open question for the Reardan references; I could not verify it.

If you want, on a fresh request I can pull the complete, verbatim "(56) References Cited" list for 8,315,886 straight from the front page / the 12/966,261 IDS and finish the § 102 mapping reference-by-reference — including opening Brill 5,299,121 to confirm its subject matter.

I'll ground this analysis in verifiable prior art. First let me check what prior-art material is actually associated with this patent and its family, including the IPR/Federal Circuit record (since the related family patents were invalidated for obviousness).

I now have the actual prior-art grounds that the PTAB and Federal Circuit used against the sibling patents in this exact family. Let me try to pin down the '886 patent's own claim language and any '886-specific proceedings.

Obviousness Analysis of US 8,315,886 under 35 U.S.C. § 103

0. Scope note and one important framing point

You asked me to use the "Prior Art section of this page." The Google Patents page supplied for this patent does not contain a separate cited-references / "Prior Art" table — what it contains is (a) a "Prior art keywords" field (patient, drug, prescriber, patients, drugs) and (b) the references discussed in the specification's own Background section (US 6,045,501 to Elsayed et al. and the Accutane/Slone Epidemiology Unit program). I therefore supplemented that material with the prior art that was actually adjudicated against this patent's sibling applications in the same family — which, for reasons set out below, is the most probative evidence for the § 103 question you are asking. Everything I cite below is drawn from the searches run for this analysis; where I could not verify something, I say so.

Critical threshold fact: US 8,315,886 ("the '886 patent") is a continuation in the same family as US 6,315,720 ("the '720 patent") and US 6,045,501 ("the '501 patent"), and it shares essentially the same specification. The '886's Summary of Invention recites verbatim the same "improved methods" language as the '720 patent (defining a plurality of patient risk groups; defining an information set probative of risk; assigning the patient to a risk group; entering the risk-group assignment in the medium). Both the '501 and the '720 patents were held unpatentable as obvious by the PTAB, and the Federal Circuit affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019). That is dispositive context: the '886 claims the same subject matter, on the same specification, and must be measured against the same art.

Claim-text caveat (carried over from the earlier sections, and it matters here). I was unable to retrieve the verbatim granted claim set of the '886 patent in this session. I did, however, find strong indirect evidence of what the '886 claims: its parent application Ser. No. 11/437,551 was being prosecuted in an Office Action dated August 12, 2010 (three months before the '886 was filed) on claims 32–38, including:

• claim 37: "The method of claim 32, wherein the acknowledgement is a written informed consent"; and
• claim 38: "The method of claim 37, wherein the written informed consent is registered in the medium prior to generation of the prescription approval code."

So the '886's independent claim very likely recites the '720-style "risk-group + acceptable-risk + prescription approval code" method, plus an acknowledgement/informed-consent element. The analysis below maps that reconstructed claim to the art and flags every place where the mapping depends on the reconstruction. A § 103 opinion on the granted claims should be confirmed against the actual claim language from USPTO PatentCenter.

1. Legal framework and the governing date

Under Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), I assess (i) the scope and content of the prior art, (ii) the differences between the prior art and the claims, (iii) the level of ordinary skill, and (iv) objective indicia of non-obviousness. A claim is obvious if the differences would have been obvious to a person of ordinary skill (POSA) — including where a known technique is used to improve a similar device or method, or where known elements are combined to achieve a predictable result (KSR).

Effective date. The '886 claims priority to October 23, 2000 through the continuation chain recited in its own Cross-Reference section (12/966,261 ← 11/437,551 ← 11/028,144 ← 10/762,880 ← 10/383,275 ← 09/965,155 ← 09/694,217). Pre-AIA § 102/§ 103 govern. The § 102(b) critical date is therefore October 23, 1999. Every reference relied on below was published between 1982 and 1999, i.e., they are all § 102(b) prior art regardless of which priority date is ultimately applied.

Level of ordinary skill. In the parallel IPRs, the Board treated the POSA as a person with several years of experience in the relevant field (medicine/clinical pharmacology plus drug-distribution practice). Nothing about the '886 changes that; it is a healthcare-workflow method, not a technology invention.

2. The prior art

2a. References named in the patent's own Background (the "Prior Art section")

• US 6,045,501 (Elsayed et al.) — methods for delivering a drug while preventing exposure of a foetus/contraindicated individual; registration of prescriber, pharmacy, and patient in a computer-readable storage medium before a prescription is filled. The '886 specification expressly characterizes this as the starting point and states the need for "improvements."
• The Accutane (isotretinoin) Pregnancy Prevention Program (PPP) and the Slone Epidemiology Unit survey — described in the '886 Background as an existing, surveyed, teratogen risk-management program.

2b. Prior art adjudicated against this family (IPR record for the '501 and '720 patents)

3. Element-by-element mapping of the '886 independent claim

Taking the reconstructed claim (risk groups → information set → assignment → entry in the medium → acceptable-risk determination → prescription approval code, plus acknowledgement/informed consent):

Result: every element of the reconstructed independent claim is disclosed, and the only element the Board ever treated as the "hard" one — the prescription approval code — was found in Cunningham, whose "pharmacy approval code" the Board construed to meet the limitation under the broadest reasonable interpretation, a construction the Federal Circuit affirmed. Celgene's attempt to narrow "prescription approval code" to "a code representing an affirmative risk assessment based on risk-group assignment" was rejected.

4. The combinations, and the motivation to combine

The Federal Circuit in Celgene v. Peter affirmed findings that these precise combinations rendered the '720 and '501 claims obvious. Since the '886 shares the same specification and the same inventive content, the same four grounds apply:

Combination A — Powell + Mitchell + Dishman (the ground that invalidated the '501 patent).
Why combine: All three are drug-restriction programs for drugs with severe adverse effects (thalidomide, isotretinoin, clozapine). Mitchell supplies the express motivation — it tells the POSA that the Accutane program's experience "can serve as a basis for considering how [thalidomide] should be used and monitored." The PTAB found "a person of ordinary skill in the art would have been led to combine… the disclosures… to address the problem of limiting thalidomide access."

Combination B — Thalomid PI + Cunningham + Zeldis (+ Keravich, Mundt) (the ground that invalidated the '720 patent in IPR2015-01096).
Why combine: The Thalomid PI discloses the entire S.T.E.P.S./risk-restriction workflow except a machine-issued code; Cunningham supplies the known, generic "pharmacy approval code" mechanism. The rationale is the classic KSR "known technique to improve a similar [method]" rationale: one of skill, seeking to enforce the Thalomid PI's pregnancy-test-before-dispensing rule, would implement the validation-and-approval-code mechanism of Cunningham. Zeldis supplies the periodic-survey and 28-day-supply features.

Combination C — Powell + Dishman + Cunningham (+ Mann) (IPR2015-01102).
Why combine: Powell supplies thalidomide risk restriction, Dishman supplies a computerized registry that dispenses only upon an "acceptable" test result (i.e., the acceptable-risk determination), and Cunningham supplies the approval code. Mann supplies the semen/teratogen teaching that motivates the male-patient counseling limitation.

Combination D — Mitchell + Dishman + Cunningham (+ Mann) (IPR2015-01103) — same as C but using Accutane as the base reference.

Combination E (for the acknowledgement/informed-consent element of the '886) — any of A–D further in view of the Accutane PPP Package (1994), CPMS, or the Thalomid PI's acknowledgment requirement. Each of these teaches obtaining a patient's acknowledgment/consent before the drug is released.

The decisive motivation evidence is Celgene's own conduct. As the PTAB and the antitrust complaints note, Celgene told FDA that its thalidomide plan "is built on experience with restrictions on such other drugs with severe adverse effects as Accutane … and Clozaril." A patentee cannot tell FDA that its program is built on Accutane and Clozaril and then tell the PTO that combining Accutane/Clozaril-type programs with thalidomide would not have been obvious.

5. Why the '886 adds nothing patentable over the invalidated '720

Even if the '886's independent claim carries the extra "risk-group assignment entered in the medium before approval" and the "written informed consent registered before generation of the code" limitations (which the parent's claims 32–38 suggest), those limitations are squarely met:

• Entering risk-group data in the medium before dispensing — Dishman's clozapine registry does precisely this ("dispense… only upon the pharmacist's verification that the WBC count is within acceptable limits").
• Written informed consent registered before the code is generated — the Thalomid PI requires the patient/physician to acknowledge the thalidomide warnings before the prescription is issued, and the Accutane PPP and CPMS both involve enrollment/consent paperwork. Registering that acknowledgment before code generation is the mere ordering of known steps with no new technical effect.

Under KSR, a continuation that merely recites the prior art's known steps in a workflow ordering is obvious; and where the parent's claims have been held obvious on a given specification, a continuation with the same specification stating the same invention is obvious for the same reasons.

6. Objective indicia of non-obviousness — likely unavailing

Celgene's secondary-considerations case was already litigated and lost for this family. In the '501/'720 IPRs, Celgene advanced long-felt but unmet need, industry praise, unexpected results, and "skepticism that zero risk was achievable." The Board found each unpersuasive, and the Federal Circuit held substantial evidence supported those findings. For the '886, the same arguments face two additional problems:

1. No nexus. The commercial embodiment (S.T.E.P.S./RevAssist) is the embodiment of the earlier patents; the '886 was filed in 2010, after the program had already been in public use since 1998. Praise for S.T.E.P.S. does not rebut the obviousness of the '886 claims.
2. The claims were not what obtained approval of the program — the program predates the '886 by more than a decade.

7. Additional § 103-relevant prosecution facts (context, not legal conclusions)

• During prosecution of the parent 11/437,551, the Examiner applied § 103 rejections that were later withdrawn, and applied § 101 rejections that Celgene argued against on Bilski grounds (the '886 issued in 2012, before Alice). The withdrawal of the § 103 rejection is not a merits adjudication of the art relied on above.
• The antitrust complaints allege (as Walker Process fraud, not as a § 103 defense per se) that the '886 application failed to disclose the PPP Package and the CDC Transcript and other material prior art. If those allegations are accepted, the '886 would face both a § 103 problem (the undisclosed references supply missing elements) and an inequitable-conduct/unenforceability problem.

8. Bottom line

On the reconstructed independent claim (and on the parent's own claim language), US 8,315,886 would have been obvious under § 103 over multiple combinations of pre-October-1999 art — most directly:

• Cunningham (US 5,832,449) in view of Powell, Mitchell, Dishman, Thalomid PI, Zeldis, and Mann;
• with the additional acknowledgement/informed-consent limitations met by the Accutane PPP Package / CPMS / Thalomid PI.

The motivation to combine is supplied by (i) Mitchell's express suggestion to apply the Accutane program to thalidomide, (ii) the KSR "known technique / predictable result" rationales (using a known approval-code/validation mechanism to enforce an existing dispensing restriction), and (iii) Celgene's own FDA representations that its thalidomide program was built on the Accutane and Clozaril programs. The PTAB and the Federal Circuit reached exactly this conclusion for the '501 and '720 patents on the same specification — and the '886 is a same-specification continuation of the '720 that adds no substantively new subject matter.

9. Confidence and limitations

• High confidence: the identity/provenance of Powell, Mitchell, Dishman, Cunningham (US 5,832,449), Thalomid PI, Zeldis, Mann, Keravich; that the '886 shares the '720/'501 specification; that the '501 and '720 were held obvious and affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019); that no '886-specific IPR/CAFC 2026 activity was found (consistent with the earlier litigation section).
• Moderate confidence (verify): the precise wording and number of the '886's independent/dependent claims. My reconstruction is grounded in (a) the '886's own Summary of Invention (identical to the '720), and (b) the August 12, 2010 Office Action on parent application 11/437,551 claims 32–38. Pull the granted claims from USPTO PatentCenter before relying on this in a filing.
• Not verified: whether any party ever petitioned for IPR against the '886 itself; my searches surfaced only the '501 and '720 IPRs plus the D.N.J. district-court and antitrust matters.

If you want, on a fresh request I can (1) retrieve the actual granted claim text of the '886 from PatentCenter/Global Dossier and re-run the element-by-element chart against the true claim language, or (2) build a formal claim-chart-style invalidity table for a specific primary-reference combination (e.g., Thalomid PI + Cunningham + Zeldis).