US 11994522

I'll verify the details against live sources before summarizing.

Let me try to pin down the claim text and any litigation involving this patent.

Let me retrieve the full claim set from an authoritative source.

Verification note

I pulled from the fetched Google Patents full text (authoritative for the specification), plus Justia/FPO/publication records for claim text and bibliographic data. One caveat up front: the Google Patents fetch you supplied contains no claims section (it ends mid-Example 2). So the claim analysis below is based on the pre-grant publication US 2021/0011028 A1 (the publication of application 16/890,943, which granted as US 11,994,522), which is the same application. I could not independently verify that the granted claim set is verbatim identical to the published one. The granted text controls.

I also could not find any CAFC 2026 docket or district-court complaint specifically asserting U.S. 11,994,522. See "Litigation" below — treat that as an explicit negative finding, not a confirmed absence.

Bibliographic summary — US 11,994,522 B2

Abstract (as issued)

"The subject invention provides a robust, quantitative, and reproducible process and assay for diagnosis of a neurological condition in a subject. The invention provides measurement of two or more biomarkers in a biological fluid such as CSF or serum resulting in a synergistic mechanism for determining the extent of neurological damage in a subject with an abnormal neurological condition and for discerning subtypes thereof or tissue types subjected to damage."

Independent claim(s), in plain language

Based on the published 15-claim set, there appears to be one independent claim (claim 1), with claims 2–15 dependent. (The specification's Summary also describes a substrate/instructions "assay," but no independent assay or kit claim appears in the published set.)

Claim 1 — a two-marker "measure and compare" process. A process for determining the neurological condition of a subject (or cells from the subject), having two steps:

1. Measure a sample from the subject/cells at a first time for (a) a quantity of a first biomarker selected from the group of GFAP, UCH-L1, NSE, MAP2, S100b, or a SBDP, and (b) a quantity of at least one additional neuroactive biomarker (necessarily a different marker); and
2. Compare both measured quantities to normal levels of those same markers to determine the subject's neurological condition.

Notably absent from claim 1: any treatment step, any specific concentration threshold, any required sample type, and any required detection technology. It is a diagnostic-information claim whose novelty hook is the concurrent use of two neuroactive markers, one drawn from the enumerated sub-group.

Representative dependents worth flagging:

• Cl. 2 — sample is CSF or blood serum.
• Cl. 3 — sample is a cell culture exposed to a drug candidate or environmental contaminant (i.e., a screening-type use).
• Cl. 6 — second measurement at a second time → kinetic profile.
• Cl. 7 / Cl. 9 — comparison against other individuals of the same gender; wherein first marker is UCH-L1 and the subject/subject cells have been exposed to TBI ranging from mild to severe.
• Cl. 10 — predicting mortality from the UCH-L1 and GFAP quantities.
• Cl. 11 — the numeric cutoffs recited in the granted Summary: MMTBI detection cutoffs in serum of 0.39 ng/mL (UCH-L1) and 1.4 ng/mL (GFAP).
• Cl. 4, 5, 12–15 — identity of the "additional" biomarker: the broad list (cl. 4), the preferred sub-list (cl. 5: GFAP, UCH-L1, NSE, SBDP150, SBDP150i, SBDP145, SBDP120, or MAP2), or specifically S100b / an SBDP / NSE / a MAP.

Litigation / post-grant posture

• Darts-ip flag only: Google Patents states the family has litigation ("First worldwide family litigation filed") and links a Darts-ip family record (family 41669607). I could not resolve to a specific U.S. case name, court, or docket number for the '522 patent, and I found no CAFC 2026 docket or appellate decision naming U.S. 11,994,522. My honest position: no authoritative confirmation of a 2026 CAFC matter on this specific number.
• EP opposition is real and documented: Justia's reference list for the '522 patent includes "Statement of grounds of appeal, for Opposition for EP 09807153.3, dated Nov. 24, 2021." Third-party data (IP Verse) records two oppositions faced by Banyan Biomarkers, one of which is titled "Biomarker Detection Process And Assay Of Neurological Condition." So the European counterpart of this family has been contested, even though I found no matching U.S. litigation.
• Ongoing prosecution: the family is not static — US 12,601,749 B2 issued in April 2026 from continuation 18/637,770, which means new claims from this disclosure are still coming online. If you are doing FTO or validity work, the '522 patent is not the last word in the family.

Conflicting / low-reliability sources (flagged)

• A site ("patentleaderboard.com") attributes this patent, and inventor Uwe Mueller generally, to Robert Bosch GmbH. That is inconsistent with the patent's own face (Uwe R. Mueller, Alachua, FL; assignee Banyan Biomarkers). Treat that attribution as an automated name-match error, not fact.
• Justia lists assignee as Banyan Biomarkers (Durham, NC) while Google Patents' recorded assignment shows bioMérieux, Inc. as of Jan. 13, 2026. The recorded assignment is the better evidence; Justia is likely stale.
• Justia lists inventor Zhiqun Zhang at "Auburndale, MA"; the Google Patents record lists no address. Minor, but note the discrepancy.

I'll research litigation involving US Patent 11994522 across patent litigation databases and court records.

Let me search more targeted litigation databases and the patent family litigation records.

Let me check federal court records and CourtListener for this specific patent.

Findings: Litigation Involving U.S. Patent No. 11,994,522

Bottom line: I could not identify any U.S. district court litigation, ITC action, PTAB proceeding, or Federal Circuit appeal that specifically names U.S. Patent No. 11,994,522 ("Biomarker detection process and assay of neurological condition") as an asserted or challenged patent. Below I explain what I searched, what I found, and the important caveats.

1. Searches performed

I queried a range of open sources, including patent-litigation aggregators, PTAB petition/decision repositories (ptacts.uspto.gov, docketalarm), court document mirrors, and general web/patent databases:

• Searches on the exact string "11994522" combined with litigation terms;
• Searches on the assignee/patentee ("Banyan Biomarkers," now Biomerieux, Inc.) and the patent title;
• Searches for the patent family and its known enforcement/opposition activity.

No source returned a case caption, docket number, court, or filing date identifying U.S. 11,994,522 as a patent-in-suit.

2. What the record does show (family-level, not this patent)

The one litigation-adjacent item I could confirm concerns the European family member, not the U.S. patent:

• EP 2,324,360 B1 — same title and family (application EP09807153.3, filed Aug. 11, 2009), granted to Banyan Biomarkers on Jan. 31, 2018.
  • Opposition filed by Taylor, David (admissible, docketed Oct. 31, 2018) before the EPO Opposition Division.
  • On appeal, T 1780/21 ("Biomarker detection/BANYAN BIOMARKERS"), decided 13 December 2023, the Board of Appeal (3.3.08) set aside the appealed decision and revoked the patent (proprietor withdrew agreement to the text). URL: https://www.epo.org/en/boards-of-appeal/decisions/t211780eu1

This is an EPO opposition/appeal proceeding, and it targets a different patent (the EP member), not U.S. 11,994,522.

3. Other notes

• The Google Patents page for U.S. 11,994,522 carries a boilerplate "Family has litigation" / "First worldwide family litigation filed" flag with a Darts-IP family link (family 41669607). That flag is auto-generated at the family level and its content is paywalled; it does not, by itself, identify a U.S. case against this patent. It is most plausibly driven by the EP opposition activity described above, but I cannot confirm this from open sources.
• The patent is currently assigned to Biomerieux, Inc. (reassignment recorded Jan. 13, 2026, per the Google Patents assignment record), having originated with Banyan Biomarkers, Inc.
• A continuation, U.S. 12,601,749 B2 (from application 18/637,770), issued April 14, 2026, indicating the family is still being prosecuted/enforced.

4. Important caveats

• My search tools have known gaps. U.S. district court complaints are not universally indexed in free databases immediately, and PTAB petitions may be listed only by petition number and challenged patent. A very recent (2025–2026) suit asserting this patent might not yet appear in the sources I reached.
• The Darts-IP "family litigation" flag is behind a paywall and could reference non-U.S. proceedings or older family members (e.g., U.S. 8,999,573 / 7,291,710 / 7,396,654 lineage) rather than this specific patent.
• I could not retrieve PACER directly, and my attempt to pull CourtListener results for the exact number returned no output before the search budget was exhausted.

5. Recommended verification steps (definitive sources)

To confirm definitively, the following should be checked directly:

1. PACER / CourtListener RECAP — search the patent case type for the exact string "11,994,522."
2. USPTO Patent Center / PTAB for this patent's "Litigation" and "Post-Grant" tabs (these link any district court or PTAB proceedings).
3. Lex Machina / Docket Navigator / Darts-IP family 41669607 — the family flagged on the Google Patents page.
4. Track Biomerieux, Inc. (current assignee) as plaintiff, since any new enforcement action post-January 2026 would be brought in its name.

Summary: No litigation specifically involving U.S. 11,994,522 was found in the sources searched. The only confirmed contentious proceeding in this patent family is the EPO opposition/appeal against EP 2,324,360 B1 (opponent: David Taylor; revoked in T 1780/21, Dec. 13, 2023). I cannot rule out a very recent U.S. filing that has not yet surfaced in the open databases I could reach.

I'll start by checking for any PTAB proceedings or related litigation activity on this patent and its family.

Let me dig deeper on PTAB activity against this patent family and related litigation.

PTAB proceedings overview

Total AIA trial proceedings on file: 0. The USPTO Open Data Portal structured block supplied for this patent returns no AIA trial proceedings — zero IPRs, zero PGRs, zero CBM reviews — and my web searches surfaced no PTAB docket entries for U.S. Patent No. 11,994,522 either (independent PTAB-tracking data for the assignee, Banyan Biomarkers, shows 0 PTAB cases filed and 0 faced). Breakdown by status: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0.

Bottom line for a defendant: there is no IPR-based shortcut here, and equally no IPR-based estoppel. All claims of US 11,994,522 are UNTESTED before the PTAB. Nobody has ever tried to invalidate this patent at the Board, so there is no FWD to cite, no canceled claim to point at, and no § 315(e)(2) estoppel constraining you. The patent is un-narrowed and presumptively valid under § 282, but it is also un-hardened — an IPR petitioner today would be the first, with the full universe of prior art available and no adverse Board precedent to overcome.

One adjacent data point matters a great deal, and it is foreign: the European member of this same family was revoked on appeal (T 1780/21, 2023-12-13). That is not a PTAB proceeding and has no direct U.S. effect, but it is the single most useful signal about how this disclosure fares when actually challenged. Details below.

No AIA proceeding to report

There is no proceeding number, petitioner, panel, institution decision, FWD, settlement, or appeal to itemize. Per the operating rule, the default is "no PTAB activity on file," and every source I checked is consistent with that default:

• USPTO ODP API (as supplied): no AIA trials.
• Independent PTAB case-tracking data for the patent owner (Banyan Biomarkers, now bioMérieux, Inc. per the 2026-01-13 assignment): no PTAB cases filed or faced.
• Newer proceedings that did surface in searches (e.g., IPR2025-00280/00281, IPR2025-00934, IPR2024-0078x series) involve unrelated patents and unrelated parties and are not proceedings against US 11,994,522. I am not importing them.

Two caveats I will not paper over:

1. Family litigation flag. The Google Patents record for this family carries a "Family has litigation" indicator pointing to Darts-IP family 41669607. I could not identify the specific case(s) or venue, and I could find no U.S. district court action asserting US 11,994,522. Treat the flag as unverified and worth a PACER/Darts-IP pull if you are evaluating exposure.
2. The ODP block is limited to AIA trials. It would not reflect an ex parte reexamination or a district-court validity holding. I did not find either for this patent, but I am not representing that I performed an exhaustive reexam-file search.

Adjacent challenge on the same family (NOT a PTAB proceeding)

I include this because it is the only adversarial validity record in the family, and a defendant should know about it — clearly labeled so it is not mistaken for an AIA trial.

EP Opposition / Appeal — Opponent: Taylor, David v. Patent Proprietor: Banyan Biomarkers, Inc.

• Forum: European Patent Office, Opposition Division → Board of Appeal 3.3.08 (not the PTAB; no U.S. estoppel effect)
• Patent at issue: EP application No. 09807153.3 — the European member of the same PCT/US2009/053376 family, title "Biomarker detection process and assay of neurological condition"
• Opposition published: 2018-01-31
• Appeal: T 1780/21, decision dated 2023-12-13, ECLI:EP:BA:2023:T178021.20231213
• Disposition: "The decision under appeal is set aside. The patent is revoked." Board keywords: "Basis of decision – text or agreement to text withdrawn by patent proprietor; Basis of decision – patent revoked." In plain English, the proprietor withdrew its approval of the text on file, which compels revocation rather than maintenance in amended form — a decision made by the patent owner, not a merits win for the opponent on novelty or inventive step.
• US relevance: A foreign revocation is not binding on U.S. courts or the PTAB and does not cancel any U.S. claim. But the opposition file is public and its prior art and arguments are citable as evidence — and in an IPR petition, EPO opposition/BoA reasoning drawing on the same disclosure can be persuasive to a panel. Note the same opponent family ("Taylor") is tracked as facing/filing multiple oppositions in the Banyan portfolio, including a second opposed Banyan patent ("Micro-RNA, Autoantibody and Protein Markers for Diagnosis of Neuronal Injury") — i.e., a repeat third-party challenger on the European side, not a coordinated PTAB campaign.

Strategic summary

Claim status. No claim of US 11,994,522 is CANCELED. No claim is SUSTAINED. Every claim is UNTESTED. There is no claim-narrowing to describe because no U.S. post-grant proceeding has ever reached a final written decision. The only validity narrowing anywhere in the family happened in Europe, where the EP member was revoked on 2023-12-13 — and even that turned on the proprietor's own withdrawal of consent to the claim text, not on a substantive unpatentability holding. If someone sends you a demand letter citing US 11,994,522, do not assume any weakness: the U.S. patent stands exactly as granted on 2024-05-28, with a presumptive § 282 validity shield and no adverse PTAB precedent.

Estoppel landscape. Because no IPR/PGR was ever instituted, § 315(e)(2) estoppel does not attach to anyone. There is no pool of "grounds raised or reasonably could have been raised" that has been burned. Every § 102/§ 103 combination available against this patent is still available — to you, and to any other defendant, and to any defensive aggregator. This is the mirror image of the usual situation: you are not barred, but you also cannot free-ride on someone else's win. The clock that does matter is § 315(b): if you are served with a complaint asserting this patent, you have one year from service to file an IPR. Secondary considerations cut the other way: the patent's anticipated expiration is 2029-08-11 per the USPTO record, so the remaining exclusivity window is roughly three years — weigh that against the cost of a petition.

Pattern signals. (i) No petitioner has ever filed at this patent — not a single one. For a patent family with a commercially launched product (Banyan BTI, the first FDA-authorized TBI blood test using UCH-L1/GFAP) and a now-large corporate owner (bioMérieux, assignment recorded 2026-01-13), the complete absence of PTAB challenges is notable; either the family has been quietly licensed, or competitors have preferred design-arounds, EPO oppositions, or simply waiting out a 2029 term. (ii) The patent owner shows no pattern of aggressive PTAB appeal practice — there is nothing to appeal. (iii) No defensive aggregator (Unified Patents, RPX, etc.) appears anywhere in the chain. (iv) The family is still being prosecuted: a further continuation, US 12,601,749 B2, claims priority back to application 16/890,943 (priority filing 2024-04-17). Any IPR strategy aimed only at US 11,994,522 may be met with assertion of the newer continuation instead — scope your freedom-to-operate analysis across the family, not the single patent.

Recommended next steps

1. If you are a defendant and you were hoping for a canceled claim to cite: there isn't one. The absence of any FWD means there is no public USPTO disposition of any claim of US 11,994,522 to link to. Do not represent to a court or an adversary that any claim has been invalidated — the only revocation is the EP member (T 1780/21, ECLI:EP:BA:2023:T178021.20231213, decision 2023-12-13), which has no U.S. effect.
2. If you intend to file an IPR, you would be the first petitioner. Docket milestones you would own: petition filing (within 12 months of service under § 315(b)), the Board's § 314(b) institution deadline at 6 months from the petition's filing date, an optional oral hearing requested under 37 C.F.R. § 42.70 approximately 2–4 months before decision, and the statutory FWD due date of 12 months from institution (§ 316(a)(11)). There is no Fintiv-type parallel-litigation record here to weigh against institution, since I could find no U.S. case asserting this patent.
3. Mine the EPO opposition file. The T 1780/21 file and the underlying opposition against EP 09807153.3 are public and contain the opponent's art and argument on this exact disclosure. Even though European outcomes are non-binding, that art can be repackaged as IPR grounds, and the BoA's reasoning can support a § 103 motivation-to-combine narrative.
4. Verify the litigation flag before relying on this clean PTAB picture. Pull Darts-IP family 41669607 and run PACER for the patent number and for Banyan Biomarkers, Inc. / bioMérieux, Inc. as parties. A live U.S. case asserting this patent would start your § 315(b) clock and could change the institution calculus under § 314(a).
5. Treat the absence of PTAB activity as a signal in itself, but a modest one. Well-asserted, high-revenue patents usually attract IPRs. Here the more likely explanations are the short remaining term (expiry 2029-08-11) and the pre-emption of the space by the 2018 FDA clearance — not that the claims are impregnable. If you want a validity read, commission a prior-art search against the 2008-08-11 priority date; the field of GFAP/UCH-L1 serum TBI diagnostics was crowded, and the WO 2010/019553 search report already flags US 2005/0260697 (Wang) and EP 1519194 (Roche Diagnostics) as X-category art against related claims in this family.

I'll verify the assignment chain, current ownership, and litigation history before reconstructing the record.

Let me pin down the litigation history, Banyan's corporate status, and any assignment-record detail.

US 11994522 B2 — Assignment / Ownership Reconstruction

Patent: US 11994522 B2 — "Biomarker detection process and assay of neurological condition"
App. No.: 16/890,943 · filed 2020-06-02 · granted 2024-05-28 · priority 2008-08-11 · anticipated expiration 2029-08-11
Family: continuation of 15/709,368 (2017-09-19) ← 13/058,748 (2011-02-11, national stage of PCT/US2009/053376, filed 2009-08-11) ← provisionals 61/188,554; 61/097,622; 61/218,727; 61/271,135.

Data-source caveat (read first). Google Patents' legal-events timeline for this patent exposes the conveyance type, assignor, assignee and recording date of each recorded assignment, but it does not expose reel/frame numbers or the correspondent of record. Those fields live only in the USPTO Patent Assignment Center record, which I could not open for this patent within this session. Accordingly, every reel/frame and correspondent field below is marked NOT CAPTURED rather than guessed. No reel/frame number has been inferred or fabricated. Verification link: https://assignmentcenter.uspto.gov/ (search patent number 11994522) — see also https://patents.google.com/patent/US11994522/en.

Inventors

Pattern note. All four inventors are Banyan-affiliated (two are named company founders), so there is no observable "mass inventor departure within 12 months of filing" pattern for this application. One weak cross-reference: on the related Banyan patent US 10,041,959 (filed 2016), Zhang is listed with a Auburndale, MA address while Hayes remained at Alachua, FL — i.e., at least one Banyan-linked inventor relocated out of the core Florida/San Diego orbit. That is an observation about a sibling record, not a finding about US 11994522's filing-time workforce, and departure dates cannot be established from the material reviewed. Unclear.

Original assignee

Banyan Biomarkers, Inc. — named assignee on the face of US 11994522 (and "Original Assignee" per Google Patents). Headquarters: 13400 Progress Blvd., Alachua, FL (early), later 16470 West Bernardo Drive, Suite 100, San Diego, CA 92127 (address of record on the Feb. 2018 FDA De Novo letter, DEN170045).

• Primary line of business: in vitro diagnostics — discovery, validation and commercialization of brain-injury protein biomarkers (UCH-L1, GFAP, SBDPs, MAP2), plus fee-for-service biomarker testing for pharma preclinical/clinical programs. Founded 2002 by Ron Hayes, Kevin Wang and Nancy Denslow out of University of Florida / McKnight Brain Institute research; supported by >$20M in DoD and NIH grants (some collateral references cite >$70M).
• Did it ship a product embodying the claims? Partially / qualifiably yes. Banyan obtained FDA De Novo authorization for the "Banyan BTI" on 2018-02-13/14 (DEN170045) — the first FDA-authorized blood test for concussion — a chemiluminescent sandwich ELISA that quantifies UCH-L1 and GFAP in serum, exactly the two-marker readout claimed here. However, the BTI ran on a 96-well plate reader, took 4–5 h, and per a 2024 review "[never] directly entered the clinical marketplace" at scale. Commercialization instead flowed through licenses: Abbott (i-STAT Alinity TBI cartridge, FDA-cleared Jan. 2021) and bioMérieux (VIDAS TBI UCH-L1/GFAP, CE-marked Oct. 2023). So Banyan held clearances and sold/marketed an assay kit and services, but its IP monetization was predominantly licensing to larger IVD manufacturers.
• Current status: Banyan took a ~$7M equity investment from bioMérieux in Jan. 2017 and gave bioMérieux worldwide commercialization rights. The recorded transfer of this patent to bioMérieux, Inc. on 2026-01-13 is consistent with bioMérieux having absorbed Banyan's IP. Whether Banyan Biomarkers, Inc. is today operating, wound down, or dissolved could not be confirmed from the sources reached in this session — unclear.

Assignment timeline

The USPTO record (as surfaced via Google Patents legal events) contains four recorded post-filing entries for this patent. Two are change-of-address only; one is the founder-to-company assignment; one is the sale to bioMérieux.

• Executed date not captured / recorded 2021-04-02 — Reel NOT CAPTURED

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: ZHANG, ZHIQUN; HAYES, RONALD L.; MUELLER, UWE R.; WANG, KEVIN KA-WANG (the four named inventors)
  • Assignee: BANYAN BIOMARKERS, INC.
  • Correspondent: NOT CAPTURED — cannot confirm or deny recurrence
  • Context: Standard employee/founder in-house assignment perfecting company ownership of the continuation application.

• Executed date not captured / recorded 2024-03-15 — Reel NOT CAPTURED

  • Conveyance: Change of Address of Assignee (Change of Name/Address family — administrative, no change in ownership)
  • Assignor: BANYAN BIOMARKERS, INC.
  • Assignee: BANYAN BIOMARKERS, INC. (address updated)
  • Correspondent: NOT CAPTURED
  • Context: Internal record-keeping only — no transfer of rights; consistent with the Alachua, FL → San Diego, CA relocation.

• Executed date not captured / recorded 2024-11-12 — Reel NOT CAPTURED

  • Conveyance: Change of Address of Assignee (administrative)
  • Assignor: BANYAN BIOMARKERS, INC.
  • Assignee: BANYAN BIOMARKERS, INC.
  • Correspondent: NOT CAPTURED
  • Context: Internal record-keeping only — second address update in the same year, coinciding with the patent's 2024-05-28 grant.

• Executed date not captured / recorded 2026-01-13 — Reel NOT CAPTURED

  • Conveyance: Assignment of Assignor's Interest
  • Assignor: BANYAN BIOMARKERS, INC.
  • Assignee: BIOMERIEUX, INC.
  • Correspondent: NOT CAPTURED
  • Context: Asset/corporate acquisition by a large operating IVD manufacturer — the culmination of the 2017 bioMérieux–Banyan partnership and equity investment, not a transfer to a licensing vehicle.

Missing-record disclosure. The four entries above are the complete set of post-filing legal events shown for this patent; I found no intermediate assignments, no security interests, no LLC intermediaries, and no recorded licenses. I could not obtain reel/frame numbers or correspondent names — if those matter to your analysis, they must be pulled directly from Assignment Center. There is no basis to assert a fifth or alternative link.

Timeline diagram

timeline
    title Ownership of US 11994522
    2008 : Priority provisional filed
    2009 : PCT application filed
    2011 : US national stage entered
    2017 : Parent continuation filed
    2020 : Continuation filed as 16 890 943
    2021 : Inventors assign rights to Banyan Biomarkers
    2024 : Patent granted as US 11994522
         : Banyan records change of address
         : Second change of address recorded
    2026 : Assigned to bioMerieux Inc

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. Both substantive links run operating company → operating company: inventors → Banyan Biomarkers, Inc. (2021-04-02) and Banyan → bioMérieux, Inc. (2026-01-13). No "IP / Holdings / Licensing / Ventures" vehicle appears anywhere in the chain, and no single-purpose Delaware/Texas LLC is named as assignee.

2. Known asserter in the chain — NOT PRESENT. Neither Banyan Biomarkers, Inc. nor bioMérieux, Inc. appears on the standard NPE rosters (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Round Rock, Spielberg/Spangenberg entities, etc.). bioMérieux is a € multi-billion in-vitro diagnostics manufacturer (Marcy-l'Étoile, France) with 42 subsidiaries in 150+ countries — the antithesis of an anonymous asserter.

3. Repeat correspondent across the chain — UNCLEAR / NOT CAPTURED. Correspondent of record is not exposed by the sources reached. With only four entries, two of which are the same party's change-of-address filings, there is no observable recurrence to flag either way. Do not treat the absence of a correspondent finding as evidence of clean ownership — it is simply unverified.

4. Cascading transfers — NOT PRESENT. One substantive change of ownership in the entire 18-year record (2026-01-13), preceded by two administrative change-of-address filings. No chained LLC hops, no sub-24-month sequencing.

5. Pre-litigation transfer — NOT PRESENT. The only post-issuance transfer (recorded 2026-01-13) postdates grant by ~20 months and postdates the priority date by ~17 years; it runs to an operating IVD manufacturer, not to an assertion vehicle, and I could not confirm any infringement suit naming US 11994522 to which it could have been timed.

6. Bankruptcy fire-sale — NOT PRESENT (unverified negative). No Chapter 7/11 record, court sale order, or docket for Banyan Biomarkers, Inc. was located. Banyan's exit appears to be a strategic/equity-driven acquisition by its 2017 investor, not an insolvency sale. Absence of a docket in my search is not proof none exists.

7. Privateering — NOT PRESENT. A transfer from an operating company (Banyan) to another operating company (bioMérieux) that itself commercializes the claimed subject matter (VIDAS TBI, CE-marked 2023) is ordinary vertical integration, not sponsorship of a proxy litigant.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents or OIN.

Adversarial-proceeding note (context, not an NPE signal). Google Patents flags "Family has litigation" for this family, and the EP counterpart EP2324360 B1 ("Biomarker detection process and assay of neurological condition," same title) was opposed (opponent "Taylor, David," opposition filed 2018-10-31) and ultimately revoked — T 1780/21, decision 2023-12-13, the proprietor having withdrawn approval of the text. Sibling EP2478360 was also opposed. These are EPO oppositions against the European counterpart, not US district-court assertions of US 11994522, and the US patent remains Active. I could not confirm a US infringement action naming US 11994522 specifically.

Verdict

Operating-company assertion.

The ownership chain for US 11994522 is a clean two-step operating-company lineage — inventors to Banyan Biomarkers, Inc. (recorded 2021-04-02) and Banyan to bioMérieux, Inc. (recorded 2026-01-13), with only administrative change-of-address filings in between (2024-03-15, 2024-11-12) — and it terminates at a multinational IVD manufacturer that actually commercializes the claimed UCH-L1/GFAP readout on its VIDAS platform; not a single shell-entity, asserter, or aggregator signal is present. The one genuine caveat is evidentiary, not substantive: reel/frame numbers and correspondents of record were not obtainable, so I cannot affirmatively rule out a correspondent-recurrence pattern — but the parties themselves (a diagnostics developer and a global IVD OEM) are inconsistent with an NPE posture, and the family's only confirmed adversarial proceedings are EPO oppositions that left the EP counterpart revoked while this US patent remains active.

Verify at: https://assignmentcenter.uspto.gov/ (search patent number 11994522) · https://patents.google.com/patent/US11994522/en

I'll research the specific patent US 11,994,522 and its cited prior art references.

Let me get the actual front-page citations from the patent document itself.

I found the citation list. Let me verify the complete set of references cited in the granted patent, including any additional U.S. patents and non-patent literature.

Prior-Art Analysis — U.S. Patent No. 11,994,522

1. Patent identification (verified against the authoritative text)

Source: https://patents.google.com/patent/US11994522/en

Important procedural point on which § 102 applies. Because this is a straight continuation whose claims have an effective filing date on or before 2013‑03‑16 (the national-stage parent was filed 2011‑02‑11, the PCT 2009‑08‑11), the pre‑AIA version of 35 U.S.C. § 102 governs, assuming no claim is entitled to a later effective date. This materially changes the analysis of the IDS references below.

2. References cited on the face of the patent

The Google Patents record for the pre‑grant publication US 2021/0011028 A1 — the same application that issued as US 11,994,522 B2 — lists a "Patent Citations (6)" block:

Source: https://patents.google.com/patent/US20210011028A1/en ("Patent Citations (6)")

Reference 1 — WO 2005/113798 A2

• Full citation: WO 2005/113798 A2, "Proteolytic markers as diagnostic biomarkers for cancer, organ injury and muscle rehabilitation/exercise overtraining," University of Florida Research Foundation, Inc.; published 2005‑12‑01.
• Description: Discloses detection of αII‑spectrin proteolytic cleavage products (SBDPs, e.g., SBDP150/SBDP145/SBDP120) and other proteolytic markers, including ubiquitin C‑terminal hydrolase L1 (UCH‑L1), in biological fluids as diagnostic biomarkers of organ injury. This is applicant‑side art — the same research lineage as the 11,994,522 inventors.
• § 102 exposure: This is the only one of the six cited references that is actually prior art to this patent. Published 2005‑12‑01, it predates the 2008‑08‑11 priority date by more than one year and is therefore available under pre‑AIA § 102(b).
  • Potentially anticipates claim 1 to the extent claim 1 recites a first biomarker selected from the group of … UCH‑L1 … or an SBDP measured together with at least one additional neuroactive biomarker and compared to normal levels. If WO 2005/113798 discloses assaying two or more of the markers it enumerates in a single fluid sample and comparing the result to baseline, claim 1's "measuring…comparing" steps are met.
  • Potentially anticipates claims 2 and 4 (sample is CSF/blood serum; additional biomarker is GFAP/UCH‑L1/NSE/SBDP) insofar as the reference describes serum/CSF sampling and multiplexing of these analytes.
  • Potentially bears on claim 3 (sample is a culture of cells exposed to a drug candidate or environmental contaminant) if the reference contemplates in vitro cell‑culture screening.
  • Caveat: because the reference is common‑owned applicant art, the examiner may have treated it as § 102(b) art for the spectrin/SBDP genus but the record does not show it being applied to reject the GFAP‑centered claims. A § 103(c)-type common‑ownership disqualification does not remove a reference from § 102 anticipation; it only matters for obviousness.

References 2–6 — the five Abbott Laboratories patents

• Full citations / dates:
  • US 10,877,048 B2 — "Methods for aiding in the hyperacute diagnosis and determination of traumatic brain injury in a human subject using early biomarkers" (granted 2020‑12‑29).
  • US 10,877,038 B2 — "…using early biomarkers on at least two samples from the same human subject" (granted 2020‑12‑29).
  • US 10,849,548 B2 — "…diagnosing and evaluating a mild traumatic brain injury in a human subject using cardiac troponin I and early biomarkers" (granted 2020‑12‑01).
  • US 11,016,105 B2 — "…diagnosing and evaluating a traumatic brain injury in a human subject using a combination of GFAP and UCH‑L1" (granted 2021‑05‑25).
  • US 11,022,617 B2 — "…diagnosis and evaluation of a subject who has sustained an orthopedic injury … using GFAP and/or UCH‑L1" (granted 2021‑06‑01).
• Description: This is the Abbott GFAP/UCH‑L1 mild‑TBI assay family (the i‑STAT TBI plasma cartridge lineage). US 11,016,105 and US 11,022,617 are the closest in substance to the present claims, because they claim two‑marker GFAP + UCH‑L1 determinations in a human subject.
• § 102 exposure — critically limited: All five grant in 2020–2021, i.e., twelve years after the 2008‑08‑11 priority date. Their underlying applications claim priority to ~2017 provisional filings. Under the pre‑AIA § 102(a)/(b)/(e) framework, a reference must predate the applicant's invention date or the U.S. filing date; these do not. As cited on the face of the patent they are therefore not § 102 prior art and cannot anticipate any claim of 11,994,522.
• The one path by which they could matter: if the § 102 priority chain to 2008‑08‑11 were broken for a given claim (e.g., a claim lacking written‑description support in the 2008/2009 disclosures, so that its effective filing date became 2020‑06‑02), then AIA § 102(a)(2) would apply and these Abbott patents — as U.S. patents with earlier effective filing dates — could become prior art against the later‑effective claim. In that scenario US 11,016,105 B2 and US 11,022,617 B2, which expressly recite GFAP + UCH‑L1 determinations, would be the candidate § 102(a)(2) references. This is a contingent, priority‑dependent theory, not an on‑face anticipation.
• Interpretive note: the appearance of these five references in the citation block is best read as applicant/examiner IDS activity during 2020–2021 prosecution (i.e., a duty‑of‑disclosure submission of then‑recent competitor art), not as a substantive § 102 rejection. Nothing I retrieved shows them being applied as anticipatory art.

3. Other references embedded in the specification (context, not "cited art")

The written description also incorporates or cites, in the body rather than the front page:

• U.S. Pat. Nos. 7,291,710 and 7,396,654 (spectrin/spectrin‑breakdown‑product detection) — expressly incorporated by reference as underlying the SBDP, MAP2 and UCH‑L1 data.
• Non‑patent literature: Kobeissy, F.H., et al., Molecular & Cellular Proteomics, 2006; 5:1887‑1898; Lee et al., Pharmacological Research 23:312‑328 (2006); Cox, C.D., et al., J Neurotrauma 2008; 25(11):1355‑65; Pike et al. (1998).
• Aptamer‑making patents: U.S. 5,475,096; 5,670,637; 5,696,249; 5,270,163; 5,707,796; 5,595,877; 5,660,985; 5,567,588; 5,683,867; 5,637,459; 6,011,020.

These are cited for enablement/incorporation purposes, not as § 102 art, and none is directed to a two‑biomarker GFAP‑plus‑partner determination.

4. Bottom line

• Exactly one cited reference predates the 2008‑08‑11 priority date and is therefore capable of anticipating anything: WO 2005/113798 A2 (pre‑AIA § 102(b)). Its realistic § 102 exposure is to claims 1, 2, 3 and 4 only insofar as those claims read on SBDP/UCH‑L1 + second‑biomarker measurements in serum/CSF — not to the GFAP‑specific subject matter that the specification characterizes as the point of novelty.
• The five Abbott patents (US 10,877,048; 10,877,038; 10,849,548; 11,016,105; 11,022,617) are post‑priority references and do not anticipate any claim as the record stands. They become relevant only if the 2008 priority claim is lost for a particular claim, in which case US 11,016,105 B2 and US 11,022,617 B2 would be the principal § 102(a)(2) candidates because they expressly recite GFAP + UCH‑L1.
• Net: no cited reference is a clean anticipatory reference against the granted claims as currently supported by the 2008 priority chain.

5. Caveats and limitations (stated explicitly)

1. I could not retrieve the granted B2 front page's full "(56) References Cited" list. What I obtained is the "Patent Citations (6)" block from the Google Patents record of the pre‑grant publication US 2021/0011028 A1. The B2 may list additional U.S. patent documents, foreign patent documents and non‑patent literature that were cited during 2021–2024 prosecution and that I did not see. A definitive answer requires the printed front page of US 11,994,522 B2 or USPTO Patent Center's "References Cited."
2. I did not independently verify the filing/priority dates of the five Abbott patents; the titles and grant dates are as listed in the Google Patents citation table, and the ~2017 priority is my recollection, not something I confirmed in this session.
3. The claim text underpinning the anticipation mapping is the published‑application claim set of US 2021/0011028 A1 (claim 1 reciting a first biomarker "selected from the group of GFAP, UCH‑L1, NSE, MAP2, S100b, or a SBDP" plus at least one additional neuroactive biomarker, and comparing to normal levels; see https://patents.justia.com/patent/20210011028). The granted B2 claims may differ, and any claim‑by‑claim § 102 conclusion must be re‑run against the granted claim set.
4. One suspected data artifact: search results surfaced several citation tables containing references to unrelated technologies (Uster Technologies/LUWA textile patents; Sensormatic; Propper Mfg.; Py Mah) attached to other documents. These are not citations of US 11,994,522 and I have excluded them; do not treat them as part of this patent's prior‑art record.
5. No contradiction with the earlier litigation section. My searches confirm (a) current assignment to Biomerieux, Inc., (b) the continuation US 12,601,749 B2 (priority 2008‑08‑11, dated 2026‑04‑14), and (c) the EPO proceeding T 1780/21, decision of 13 December 2023, in which the Board of Appeal (3.3.08) set aside the appealed decision and revoked the EP member, proprietor having withdrawn its agreement to the text (opponent: David Taylor; EP application 09807153.3). Consistent with the earlier section — the revocation of the EP sibling does not, by itself, invalidate the U.S. patent, whose prior‑art posture is governed by the pre‑AIA U.S. record analyzed above.

I'll ground this in actual prior-art records before analyzing. Let me pull the "references cited" and related-art lists for US 11,994,522, plus key pre-2008 biomarker art.

Good grounding. Let me nail down a few specific references for the key limitations (outcome/mortality prediction, glial+neuronal serum panels, and the pre-2008 state of the multipanel art).

Scope note before the analysis — important

The "Prior Art section" you asked me to use was not included in the materials passed to me. The full patent text I was given (fetched from Google Patents) contains the specification, classifications, and definitions, but no "References Cited" / PTO-892 table and no dedicated prior-art section. So I cannot analyze "the references in the Prior Art section of this page" literally.

What I have done instead is reconstruct the prior art from (a) the references cited on the face of, and inside the specification of, US 11,994,522, and (b) live searches for the pre-August-2008 literature on the biomarkers the claims recite. If the page you are looking at lists a specific examiner-cited art set (e.g., a PTO-892 or a Google Patents "Cited By" list), paste it and I will re-run this against those exact references — the conclusions below could shift.

Two cross-reference flags against the earlier sections:

1. The earlier "Patent summary" reproduced claim 1 as reciting a first-biomarker group of "GFAP, UCH-L1, NSE, MAP2, S100b, or a SBDP." The granted Summary of the Invention in the authoritative full text recites only "GFAP, UCH-L1, NSE, MAP2, or SBDP" — no S100b. That gap is material (see §6 below), and the earlier section already flagged that the granted claim text could not be verified. Treat the group membership as unconfirmed.
2. The earlier section noted the '522 full-text fetch ends mid-Example 2 with no claims. That is still true. My claim-construction is therefore provisional.

1. Framework

• Governing law: The '522 patent claims priority through PCT/US2009/053376 (filed Aug. 11, 2009) to U.S. Prov. 61/188,554 (Aug. 11, 2008). If that chain holds, the operative standard is pre-AIA 35 U.S.C. § 103(a), and art must predate Aug. 11, 2008. Note that Prov. 61/097,622 was filed Sept. 17, 2008 — after the earliest priority date — so anything supported only by that provisional takes a later date.
• KSR Int'l v. Teleflex (2007) controls motivation-to-combine: predictable results, a finite number of identified/predictable solutions, and combination of known elements according to known methods are the paradigm cases of obviousness.
• Claim 1 has essentially no technical content. It recites (i) measuring a first biomarker from a six-member Markush group, (ii) measuring "at least one additional neuroactive biomarker," and (iii) comparing both to "normal levels." No threshold, no sample type, no assay format, no sensitivity/specificity, no unexpected result. That structure invites both § 103 obviousness and § 112 written-description problems — a broad genus does not confer non-obviousness (MPEP 2144.04; Atofina v. Great Lakes Chem.).
• Level of ordinary skill: a Ph.D.-level neuroscientist or protein biochemist with 2–5 years of experience, working in a team with an emergency-medicine/critical-care clinician, familiar with sandwich ELISA and Western blot quantitation of protein biomarkers — the exact techniques the specification itself calls "well known."

2. The prior art (as reconstructed)

3. Claim 1 — the combination that renders it obvious

Primary combination: US 7,396,654 + Vos 2004 (optionally + Missler 1999).

Element-by-element:

• "Measuring a sample … for a quantity of a first biomarker selected from GFAP, UCH-L1, NSE, MAP2, [S100b], or a SBDP" → '654 Table 1 names every one of these in a single TBI-biomarker panel.
• "and a quantity of at least one additional neuroactive biomarker" → '654 explicitly teaches "at least two or more proteins" and "at least one biomarker from each neural cell type." Vos 2004 supplies the concrete working example: GFAP + S100b + NSE measured in the same serum sample.
• "comparing the quantity … to normal levels … to determine the neurological condition" → Vos 2004's abstract states the markers were compared "to normal reference values" and used to predict outcome/death; '654 teaches correlating to a "control amount."

Motivation, articulated as a POSITA would: The art had already partitioned TBI biomarkers by cell of origin — GFAP/S100B = astroglial, UCH-L1/MAP2/NSE/SBDP = neuronal or axonal. '654 states the panel is chosen "to detect which cell type has been injured" and that a multi-marker panel gives "better selectivity and specificity." Vos 2004 states outright that "determination of serum levels of glial and neuronal proteins may add to the clinical assessment" — i.e., the combination is expressly motivated by the reference itself. Missler 1999 shows GFAP and S-100 measured side by side in blood, making the pairing routine. Under KSR, picking two known markers from a finite, enumerated list and running two standard sandwich ELISAs in parallel is "obvious to try."

Secondary/redundant combination: '654 + US 7,291,710. '710 supplies the SBDP species; combined with '654's GFAP/UCH-L1 entries, every limitation is met.

A single-reference theory also exists: '654 (and especially its EP sibling's claim 1 + claim 2) may anticipate claim 1 outright — claim 1 of EP 2,207,033 B1 is "an in vitro method of detecting a neural injury … wherein said protein biomarker is UCH-L1," and claim 2 adds "at least one additional protein biomarker." Whether that is anticipation or merely strong obviousness turns on whether the granted '522 claim-1 wording differs, which I cannot verify.

4. Dependent claims

• Cl. 2 (CSF or serum) — '654 teaches CSF, blood, plasma, serum, saliva, urine. Obvious.
• Cl. 3 (cell culture; drug candidate / environmental contaminant) — the closest pre-2008 art is the family's own neurotoxicity work and general in-vitro neurotoxicity screening. I could not verify a specific pre-Aug-2008 reference teaching this; flagging as the weakest link in my reconstruction.
• Cl. 6 (second time point → kinetic profile) — Vos 2004/Vissers and the earlier literature describe release and peak time courses (Missler's GFAP peak at 24 h; "time profile of NSE"); '710 discloses SBDP kinetics. Serial sampling is routine. Obvious.
• Cl. 10 (predicting mortality from UCH-L1 + GFAP) — Vos 2004 is squarely on point for GFAP + a second marker predicting death with explicit cutoffs (GFAP >1.5 µg/L, AOR 5.82). Substituting UCH-L1 for S100B as the neuronal partner would have been obvious given '654's teaching. Obvious.
• Cl. 11 (0.39 ng/mL UCH-L1; 1.4 ng/mL GFAP) — a numerical range is a classic routine-optimization case (In re Aller; In re Boesch), and GFAP/UCH-L1 are "result-effective" variables per the art. Note Vos's GFAP death cut-off (>1.5 µg/L) is ~1000× the claimed 1.4 ng/mL, so Vos does not anticipate the number — but the claimed value is the kind of threshold obtained by the patentee's own later clinical study. This limitation also has a priority problem: FIGS. 16–19 (the mild/moderate cohort and the ng/mL cutoffs) appear in the 2009–2010 filings, not the Aug. 2008 provisional. If claim 11 cannot ride the 2008 priority date, intervening art (Siman 2009; Papa 2010; Banyan's own WO 2010/019553, published Feb. 18, 2010) becomes available and the claim is at substantial risk.
• Cl. 4, 5, 12–15 (identity of the "additional" biomarker) — '654 Table 1 supplies GFAP, UCH-L1, NSE, SBDP150/145/120, MAP2, S100b and more. Obvious — indeed, selecting a species from the art's own list is the archetypal obvious selection.

5. Where the patentee retains a genuine non-obviousness argument

The strongest defense — and it is a real one — is claim 7: "comparison against other individuals of the same gender." Vos 2004 states that GFAP/S100b/NSE levels correlated with injury severity and CT findings "but not with age, sex, or GCS." That is a teaching away from gender-stratified reference values (the reason the '522 specification calls the gender difference "unexpected"). A POSITA reading Vos would not have been motivated to build same-gender comparison groups. Whether this survives depends on whether the specification's gender data were in the 2008 priority documents; if not, the intervening art (Vos 2010, Neurology 75:1786) may close the gap. This is the claim to examine most closely if you are attacking validity.

The patentee will also argue unexpected synergy ("a synergistic result is achieved," "[s]urprisingly"). That argument is weak because (i) the references themselves predict additive benefit from glial + neuronal panels, and (ii) the claim recites no numerical measure of synergy — under KSR, conclusory assertions of synergy without a claimed result-effective distinction carry little weight.

6. Contradiction to flag

The specification's own FIG. 18 discussion calls S100b "a biomarker not selected for diagnosis of neurological condition." If the granted claim 1 nevertheless includes S100b in the first-biomarker Markush group (as the earlier section reports), then the patent claims as a diagnostic marker a species the specification characterizes as not diagnostic. That is simultaneously (a) evidence that the group was drawn to cover the prior art broadly — which strengthens the § 103 case — and (b) a § 112(a) written-description problem for S100b. I could not verify the granted claim text; this is the single most important item to confirm.

7. Verification limits

• I did not have the actual "Prior Art section" or the granted claims; both are essential and should be supplied.
• The '654/EP-2,207,033 claim text I quoted came from the EP counterpart (granted 2014) — the U.S. '654 claims may differ.
• I could not confirm the publication date or content of US 2008/0204043 A1; if it published after Aug. 11, 2008 it is at most § 102(e) art and I have not relied on it.
• I could not confirm any pre-2008 reference teaching the cell-culture/drug-candidate limitation (claim 3).
• The EP counterpart EP 2,324,360 B1 was revoked in T 1780/21 (Dec. 13, 2023) — but the publicly available decision does not establish that revocation rested on obviousness, so it should not be cited as a European obviousness holding without reading the reasons.

Bottom line: on the reconstructed record, claim 1 and most dependents are prima facie obvious over US 7,396,654 in view of Vos 2004 (and Missler 1999), with US 7,291,710 supplying the SBDP/kinetic limitations. The claims with the best chance of surviving are claim 7 (same-gender comparison) — because Vos 2004 arguably teaches away — and, with caveats, claim 11's specific numeric cutoffs, which turn on a priority-date fight rather than on the merits.