US 12601749

I'll search for authoritative information on this patent, including any CAFC 2026 docket activity.

Search coverage and confidence notes

I searched for the literal identifier 12601749 / US12601749B2 and for CAFC 2026 docket activity naming it. Results (Google Patents, Espacenet, PatentGuru, ipauthor prosecution analytics) consistently confirm the patent's identity and data. I found no CAFC or district-court docket entry in 2026 naming this patent; my search was web-based, not a PACER/CM-ECF-native query, so I cannot rule out pending litigation with certainty. Legal-status and priority fields on Google Patents are expressly labeled assumptions, not legal conclusions.

Bibliographic summary — US 12,601,749 B2

Continuation chain (as recited in the specification): US 18/637,770 ← continuation of 16/890,943 (filed 2020-06-02, issued as US 11,994,522 B2) ← continuation of 15/709,368 (filed 2017-09-19; US2018/0031577A1) ← continuation of 13/058,748 (filed 2011-02-11), which is the U.S. national phase of PCT/US2009/053376. Related foreign family members include EP3336551 (now lapsed/expired, 2023-08-11), JP5781436B2, and AU2009282117B2.

Abstract (as issued)

"A robust, quantitative, and reproducible process and assay for diagnosis of a neurological condition in a subject. The method includes 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."

Plain-language overview of the independent claims

Claim 1 — diagnostic/protocol method (neurological condition, mild-to-moderate TBI).
Applies to a subject known to have, or suspected of having, mild-to-moderate TBI, with the claim itself defining mild TBI as GCS 13–15 and moderate TBI as GCS 9–12. Steps: (i) at a first time within 12 hours of the TBI/suspected TBI, measure GFAP and UCH-L1 in a sample from the subject; (ii) compare the two measured quantities against normal levels or predetermined cutoff values; and (iii) perform a head CT if GFAP and/or UCH-L1 exceed the cutoffs, or decline a head CT if neither exceeds them. The claim thus frames the biomarkers as a triage gate for CT imaging.

Claim 5 — biomarker-combination assay after TBI.
Obtain a blood sample collected from a subject having TBI within 12 hours after the TBI occurred, and measure levels of UCH-L1 and GFAP by assaying that blood sample. This is the base assay independent claim; claims 6–8 add GCS 13–15, plasma, and serum limitations respectively, and claims 9–10 build on it.

Claim 9 — method of performing a head CT scan.
Measure UCH-L1 and GFAP using the method of claim 5, and then perform the head CT when the UCH-L1 and GFAP levels exceed predetermined cutoff values.

Claim 10 — method of refraining from performing a head CT.
Measure UCH-L1 and GFAP using the method of claim 5, and then refrain from performing the head CT when the levels do not exceed the predetermined cutoff values.

Claim 11 — CT decision-making for mild TBI / suspected mild TBI.
Measure GFAP and UCH-L1 by assaying a blood sample collected within 12 hours of the (suspected) mild TBI; determine whether to perform a head CT when GFAP and/or UCH-L1 exceed predetermined cutoffs, or decline the head CT when neither does. Functionally it mirrors claim 1 without the GCS-based severity definitions.

Dependent limitations (2–4, 6–8, 12–14): GCS 13–15 (claims 2, 6, 12); plasma (3, 7, 13); blood serum (4, 8, 14). Note a literal-text oddity: claim 4 as printed on the source page recites "bloom serum." Per your strict rule I have not auto-corrected this; the parallel claims 8 and 14 recite "blood serum," so "bloom serum" appears to be a typographical artifact in the printed text of claim 4.

Points of interest / uncertainty

• Claim scope is narrower than the specification. The description is broad (GFAP + any of UCH-L1, NSE, MAP2, SBDP; CSF, serum, plasma, saliva, urine; severe TBI, stroke, neurodegeneration), but the issued independent claims are confined to GFAP + UCH-L1 in blood/plasma/serum within a 12-hour window, used as a CT-triage decision. The specification's severe-TBI/GCS≤8 examples (FIGS. 9–15) do not appear as claim limitations.
• Cutoff values are claimed functionally. The claims recite "predetermined cutoff values" without numeric limits. The specification elsewhere mentions detection cutoffs of 0.39 ng/mL for UCH-L1 and 1.4 ng/mL for GFAP, and Example 11 reports mean GFAP serum levels of 0 for controls, 0.107 (0.012) for GCS 13–15, and 0.366 (0.126) for GCS 9–12 — but these figures are not in the claims.
• Assignee status is current as reported, not adjudicated. The Google Patents page labels the assignee/legal-status entries as assumptions; the recorded 2026-01-13 assignment indicates transfer to bioMérieux, Inc.
• No CAFC 2026 activity located for US 12,601,749. The CAFC items returned by my 2026 searches concerned unrelated patents (e.g., AudienceScience v. Google; Tesla v. Charge Fusion; MPH Technologies v. Apple). If you need a definitive litigation check, a native PACER/CM-ECF and USPTO Patent Trial and Appeal Board docket query on the patent number and its family members is required; I could not confirm absence of any proceeding from web sources alone.
• Prosecution analytics (ipauthor) indicate the application went from filing to grant in roughly 1 year 12 months, granted 2026-04-14 — consistent with the continuation status and 2008 priority.

I'll search litigation databases and patent sources for this specific patent number.

Let me search litigation-specific databases for this patent number.

Bottom line

As of April 26, 2026, I found no litigation — in district court, the Federal Circuit, the ITC, or the PTAB — that names U.S. Patent No. 12601749 as an asserted or challenged patent. I could not identify any plaintiff, defendant, jurisdiction, case number, filing date, or outcome for this specific patent, because no such case appears in the sources I searched.

I want to be explicit that this is a negative finding, not a confirmation that no suit exists. Given the patent's age (see below) and my inability to run a direct PACER/RECAP docket query in this session, the correct characterization is "none found," not "none exists."

Why a null result is the expected result here

• The patent is brand new. US 12601749 B2 issued April 14, 2026 — roughly twelve days before your stated current date. Google Patents lists it as "Active," filed April 17, 2024 (application 18/637,770), as a continuation of U.S. App. Ser. No. 16/890,943 (now U.S. 11,994,522), which traces back through Ser. Nos. 15/709,368 and 13/058,748 to PCT/US2009/053376, with a priority date of August 11, 2008. A patent that issued two weeks ago will almost never yet appear in a litigation database.
• No litigation hits for the exact number. Searches for the exact string "12601749" returned only unrelated matches: a U.K. company registration number (Reloshef Limited, company no. 12601749) and an old U.S. application series 12/601,749 for an unrelated rotigotine patent. Neither is this patent.
• No PTAB proceedings surfaced for this patent or its number.

Ownership context (relevant to who could assert it)

• Original assignee: Banyan Biomarkers, Inc.
• Current assignee: bioMérieux, Inc. (assignment of assignor's interest from Banyan recorded January 13, 2026; a change-of-address assignment was recorded November 12, 2024). Because bioMérieux took ownership of this patent in January 2026, any future enforcement would most likely be brought by bioMérieux (or an exclusive licensee).

Adjacent matters I found, which are NOT litigation over this patent

I want to flag these so you don't mistake them for hits on '749:

1. bioMérieux v. QIAGEN (UPC Düsseldorf / French interim proceedings, 2025) — concerns EP 2 726 883 B2 (QuantiFERON tuberculosis diagnostics), not US 12601749, and is unrelated technology. Reported in bioMérieux's own April 11, 2025 court order document.
2. bioMérieux entities v. Labrador Diagnostics LLC (UPC Central Division Milan, ACT_48305/2024 / CC_54050/2024, EP 3 756 767 B1) — a revocation action; again unrelated to this patent.
3. Abbott Laboratories' GFAP/UCH-L1 patents (e.g., US 11,016,105; US 11,022,617; US 10,877,038; US 10,877,048; US 10,849,548) appear in this patent's citation list. These are third-party patents in the same biomarker space and represent the most likely future litigation counter-party/context, but they are not litigation involving '749.

Caveats and recommendation

• I could not directly query PACER or RECAP in this session; my searches relied on public web sources (Google Patents, Justia, CourtListener, Docket Alarm, and the Unified Patents litigation portal). A very recent complaint might not yet be indexed by any of those.
• My searches did not surface any ITC Section 337 investigation or Federal Circuit appeal tied to this number.
• If you need a definitive answer, the reliable next step is a direct docket search on PACER/RECAP (CourtListener RECAP) and the Unified Patents litigation portal using the exact number, plus a check of bioMérieux's recent docket activity as a plaintiff. I have not verified those sources in real time and should not represent them as checked.

Per your strict instruction, I have interpreted every identifier literally and have not auto-corrected any number; none of the results I found for "12601749" matched this patent.

I'll start by verifying the structured data against any public PTAB/CAFC records.

Let me check the family and any related PTAB activity more broadly.

Let me check for any PTAB filings against Banyan generally and any current assertions/district-court disputes.

Proceedings overview

Total AIA trial proceedings on US 12,601,749: 0. Breakdown: 0 active, 0 claims invalidated, 0 claims sustained, 0 settled, 0 institution denied.

The USPTO ODP structured block in this prompt reports no AIA trial proceedings for this patent, and I could not surface any IPR, PGR, or CBM anywhere in the public record for this patent number or for its immediate family members (US 11,994,522; US 12,077,601; the WO 2010/019553 / EP 2,324,360 counterpart line) despite targeted searches of PTAB petition documents, PTAB decision text, and third-party PTAB docket aggregators. One aggregator's competitor-analysis page for Banyan Biomarkers expressly reports "PTAB Cases Faced: —" (zero) alongside two European oppositions — consistent with the ODP result.

Bottom line for a defendant: this is not a "hardened" patent and it is not a "dead" patent either — it is an untested patent. The claims (1–14) have never been construed by the Board, never been through an institution decision, and carry no estoppel against anyone. That cuts both ways: (a) you face no adverse PTAB precedent on these exact claims, and (b) there is no prior petitioner who has already burned the art set or created a favorable record you can copy. The only adjudicated loss on this subject matter anywhere is in Europe, not at the PTAB (see adjacent proceedings below).

AIA trial proceedings on US 12,601,749

None. There is no proceeding to report — I will not manufacture one, and no proceeding number may be invented here. The loop below is populated only with genuinely adjacent, clearly non-AIA items so you can see what the "0" does and does not mean.

(no AIA proceeding) — no petitioner, no patent owner-side PTAB record

• Type: n/a — no Inter Partes Review, Post-Grant Review, or Covered Business Method review petition has been filed or indexed.
• Filed: n/a
• Status: n/a. The Google Patents legal-status field for the '749 patent reads "Active" with "Anticipated expiration 2029-08-11," and records a post-grant assignment to BIOMERIEUX, INC. effective 2026-01-13 (assignor BANYAN BIOMARKERS, INC.).
• Judge panel: n/a
• Petition grounds: n/a
• Institution decision: n/a
• Final Written Decision: n/a
• Settlement / termination: n/a
• Appeal: n/a — no FWD, so nothing appealable, and no Federal Circuit docket to report. Do not cite a CAFC number for this patent.
• Defensive value: Zero estoppel exists against anyone under 35 U.S.C. § 315(e)(2), and no petitioner's art set has been foreclosed. Conversely, there is no Board finding you can point to as "claims already canceled."

Why the "0" is credible rather than an indexing gap: the '749 patent only issued 2026-04-14 (application US 18/637,770, filed 2024-04-17; continuations of a 2008-08-11 priority chain via PCT/US2009/053376 filed 2009-08-11). It was granted roughly 5½ months ago. A patent that young, from a family that has existed publicly since 2010, is a plausible zero-PTAB patent — but a patent this young also means the § 315(b) one-year clock generally has not yet been triggered against anyone.

Two structural facts about the '749 that flow directly from the absence of PTAB activity:

1. PGR is not available at all. The '749 claims a 2008-08-11 priority date through PCT/US2009/053376 (filed 2009-08-11) — it is a pre-AIA patent. The PGR provisions of 35 U.S.C. §§ 321–329 apply only to patents subject to the first-inventor-to-file regime (AIA § 6(c)(2)(A)). Covered Business Method review is likewise gone — the transitional program sunset for petitions filed on or after 2020-09-16. IPR under 35 U.S.C. § 311 is the only AIA trial available against the '749.
2. That single available vehicle is narrow. § 311(b) limits IPR grounds to pre-AIA §§ 102 and 103 on the basis of patents and printed publications only. Every § 112 theory (written description, enablement, indefiniteness) and every § 101 theory (this is a method claim with a "performing a head CT / declining a head CT" step — an obvious Mayo/Alice target) must be litigated in district court, not at the PTAB.

Adjacent (non-AIA) proceedings — context only, not PTAB precedent

T 1780/21 — Opponent (Taylor, David) v. Banyan Biomarkers, Inc. (EPO Board of Appeal 3.3.08)

• Type: European Patent Office opposition appeal (EPC), not an AIA proceeding and not binding in the U.S.
• Filed / decided: Decision dated 2023-12-13, ECLI:EP:BA:2023:T178021.20231213, on EP application 09807153.3 (the European sibling of the '749's PCT).
• Status: Patent revoked. The Board order reads: "1. The decision under appeal is set aside. 2. The patent is revoked." The key legal basis recorded is "text or agreement to text withdrawn by patent proprietor" — i.e., the proprietor did not defend any claim text on appeal.
• Petition grounds: EPC grounds (added matter / Art. 123(2), clarity, etc. as filtered through Art. 101/102/103 practice) — not § 102/§ 103.
• Institution decision: n/a (opposition division), FWD n/a.
• Settlement / termination: n/a.
• Appeal: this is the appeal — disposition: revoked.
• Defensive value: Low direct value (EP-only, and a withdrawal-based loss produces no reasoned U.S.-usable merits holding), but real strategic value: it is evidence the patent family has a defense-side track record of collapse under adversarial pressure. The FR/EP record for EP 2,324,360 also shows status "Revoqué" (revoked) while EP 3,336,551 B1 (granted 2023-05-31) survived in that line.
• Link: https://www.epo.org/fr/boards-of-appeal/decisions/t211780eu1 and https://www.epo.org/en/boards-of-appeal/decisions/t211780eu1

No U.S. district court assertion confirmed

I found no U.S. litigation naming US 12,601,749 as an asserted patent. Because I could not confirm one, I am not reporting a case number — treat any docket citation you are given for this patent as unverified until it is checked on CourtListener or PACER.

Strategic summary

Claim-level status of the '749. All 14 claims are UNTESTED. The patent has four independent claims — claim 1 (process for determining neurological condition), claim 5 (method of assaying a UCH-L1/GFAP biomarker combination), claim 9 (method of performing a head CT), claim 10 (method of refraining from a head CT), and claim 11 (method of assessing a subject having mild TBI to determine whether to perform a CT scan) — plus dependents 2–4, 6–8, and 12–14. Zero claims canceled; zero claims sustained; zero claims construed. Notably, the claim 1 preamble carries an express severity limitation tying "mild TBI" to GCS 13–15 and "moderate TBI" to GCS 9–12, and every independent claim is bounded by a "within 12 hours of the TBI" timing limitation. Those are the features most likely to have been added to secure allowance over the crowded pre-2008 GFAP/UCH-L1 art (the file lists 119+ citations), including the Abbott Laboratories family (e.g., US 10,877,048; US 10,877,038; US 11,016,105; US 11,022,617). I flag — as an unverified hypothesis worth checking against the prosecution history, not as a finding — that the presence of 2017–2019 Abbott references in the citation record of a patent claiming 2008 priority raises a priority/benefit question: if any claim loses the 2008-08-11 benefit, post-2008 art becomes available. Verify that against the 18/637,770 file wrapper and the 16/890,943 parent before you build a petition on it.

Estoppel landscape. There is no § 315(e)(2) estoppel against anyone — no petitioner has ever appeared. Practically, this is the best posture a defendant can have: the entire universe of patents and printed publications is still available to you under pre-AIA § 102/§ 103. Two clocks matter: (i) § 315(b) — if you (or a privy/real party in interest) are served with a complaint alleging infringement, you have one year from service to petition, and you are barred after that; (ii) § 315(a)(1) — do not file a declaratory-judgment action of invalidity before petitioning, or you lose the IPR. Also remember § 325(d) discretion and the Fintiv-style § 314(a) discretion practice if there is a parallel district court case — neither has been litigated for these claims, so you cannot predict the panel's lean the way you could with a prior FWD.

Pattern signals. (1) Single-petitioner risk is nil — there are no petitioners. (2) No defensive aggregator (Unified Patents or similar) appears anywhere in the chain; this patent has not been crowd-sourced for attack. (3) The patent owner has never had to defend at the PTAB, and the FR/EP record shows a willingness to drop claim text rather than fight (T 1780/21). (4) Ownership just moved to bioMérieux, Inc. (assignment recorded 2026-01-13), which likely explains the timing of any future assertion campaign and materially affects your real-party-in-interest and privity analysis under § 42.8. (5) There are several live sibling patents in the same family — US 11,994,522 (parent of the '749), US 12,077,601 (anti-UCH-L1/anti-GFAP antibodies), and related U.S. grants — so an attack on the '749 alone may leave parallel claims standing against you.

Term. Anticipated expiration 2029-08-11 (~2 years 10 months from today, 2026-09-27), before any PTA/PTE. That short runway materially changes the ROI of an IPR (fees, expert costs, and an FWD that may land within months of expiry).

Recommended next steps

1. State the absence plainly in any opinion you write. There is no PTAB activity on US 12,601,749. Nothing is canceled, nothing is sustained, and no estoppel exists. Do not cite an FWD, a proceeding number, or a Federal Circuit docket for this patent — none exists. Your invalidity/Freedom-to-Operate narrative must be built from the district court side and from the prior art itself.
2. If you are served with a complaint, calendar the § 315(b) bar-date immediately (service + 1 year) and confirm no affiliate has filed a DJ of invalidity (which would trigger § 315(a)(1)). IPR is your only PTAB vehicle; PGR is unavailable (pre-AIA patent) and CBM is sunset.
3. Build the § 112 and § 101 theories for district court, not the PTAB. The independent claims are diagnostic-method claims with an active "perform / decline a head CT" step and 12-hour timing limits — the § 112 written-description/enablement attack on the GCS- and 12-hour-bounded limitations, and the § 101 attack, are simply outside § 311(b).
4. Pressure-test the priority claim as your first technical task. Pull the file wrappers for US 18/637,770, US 16/890,943, US 15/709,368, and US 13/058,748 from USPTO PatentCenter (https://patentcenter.uspto.gov) and confirm every limitation of claims 1–14 finds § 112 support in the 2008-08-11 / 2008-09-17 / 2009-06-19 / 2009-07-18 provisional chain. If it does not, the 2008–2013 intervening art (including published applications by competitors) moves into play, and the effective filing date shifts — which is the single highest-leverage argument against this patent given how crowded the field was.
5. Check sibling exposure before committing to a proceeding. Identify the assertable siblings (US 11,994,522 and the antibody claims of US 12,077,601) and evaluate whether a single IPR on the '749 is worth the spend given the 2029-08-11 expiry. A coordinated validity opinion across the family is usually cheaper than serial PTAB petitions.
6. Re-run the ODP check before filing anything. The '749 is only ~5.5 months past grant (2026-04-14); a petition could be filed between today and your filing date. Monitor PTAB E2E (https://ptab.uspto.gov) and the ODP docket for this patent number, and likewise check the EPO Register for EP 3,336,551 and EP 4,235,181 (visible under "Biomarker detection process and assay of neurological condition," Banyan/biomérieux) since that line is where the adversarial history actually is.
7. Verify the claim text before relying on it. In the authoritative text I was given, claim 5 recites "the sample is bloom serum," which appears to be an OCR/transcription artifact of "blood serum" (compare claim 8, which recites "blood serum" correctly). Confirm the exact issued wording against the USPTO-issued patent before quoting claim 5 in any paper — do not rely on the character string "bloom serum."

Confidence and limitations: I am highly confident that zero AIA trial proceedings exist for US 12,601,749 as of 2026-09-27, based on the ODP structured block plus independent web verification. I was unable to complete the district-court assertion and Federal Circuit docket checks (search budget exhausted), and I did not locate any pending IPR, PGR, or CBM petition for this patent or its immediate family. Nothing in this report should be read as citing a proceeding number, FWD, judge panel, or CAFC docket — no such items exist for this patent.

I'll investigate the assignment record for US 12601749 before writing anything. Let me pull from the sources you named.

Let me check for the bioMérieux/Banyan transaction and any legacy USPTO assignment cover sheets for this family.

US 12601749 — Ownership & NPE Reconstruction

Important limitation up front: I can read the patent's own record and the Google Patents legal‑events mirror, but the interactive USPTO Assignment Center (https://assignmentcenter.uspto.gov/) and the legacy viewer (https://assignment.uspto.gov/patent/index.html) are JavaScript‑driven search tools that my web queries could not scrape. I therefore could not retrieve reel/frame numbers, execution dates, or the assignment correspondent of record. I am not going to invent them. Everything below that is stated is grounded in retrieved sources; everything not retrievable is explicitly flagged as NOT RETRIEVED. Verify the reels directly at the Assignment Center by patent number before relying on this for any filing.

Inventors

• All four appear as the named inventors on the granted patent (source: PatentGuru inventor/assignee record for US12601749B2, which lists applicant BANYAN BIOMARKERS, INC. and agent Oliff PLC).
• The specification states the work was supported by U.S. DoD grants N14‑06‑1‑1029, W81XWH‑8‑1‑0376, W81XWH‑07‑01‑0701. This matters for chain analysis: government‑funded inventions carry Bayh‑Dole march‑in rights and a Government Interest statement, so a prospective assignee (bioMérieux) is taking title subject to those rights.
• Unusual patterns: none demonstrated. I found no evidence of inventors departing the original assignee within 12 months of filing, nor of a pre‑sale inventor exodus. This is a 2008‑priority academic/startup‑origin family, not a post‑acquisition cleanup.

Original assignee

Banyan Biomarkers, Inc. (Alachua / San Diego, CA; founded ~2002; ~$32.6M raised; SIC 2836).

• Line of business: discovery/validation of blood‑based traumatic brain injury (TBI) biomarkers — specifically the UCH‑L1 + GFAP pair that is the subject matter of these claims.
• Did they ship a product embodying the claims? Partially. Banyan obtained FDA De Novo authorization for the Banyan BTI™ (Brain Trauma Indicator) test (review DEN170045, 2018) using UCH‑L1/GFAP chemiluminescent ELISA. However, independent reviews characterize Banyan BTI as "not commercially implemented; regulatory predicate only" — i.e., it served as the regulatory predicate for others rather than achieving broad commercial distribution.
• Related commercial embodiment: the claims are practiced commercially by bioMérieux's VIDAS® TBI (GFAP, UCH‑L1) assay (CE mark 2023; FDA 510(k) clearance 28 May 2024; launch H2 2024) and, adjacently, by Abbott's i‑STAT/Alinity TBI assays. Banyan's BTI is the predicate for Abbott's mTBI indication.
• Current status: acquired — bioMérieux took an equity stake (~$7M, Jan 2017 partnership) and ultimately consolidated ownership; company profiles now render the entity as "Banyan Biomarkers Inc (acquired by bioMerieux)." I found no bankruptcy or Chapter 7/11 proceeding. Status: acquired/integrated (not dissolved per available records, but no longer an independent operating concern).

Assignment timeline

Source: Google Patents legal‑events register for US12601749B2 (mirror of the USPTO assignment database). Two post‑filing reassignment events are recorded. Reel/frame, execution date and correspondent were NOT RETRIEVED from the Assignment Center and must be confirmed there.

• Executed: NOT RETRIEVED / recorded 2024‑11‑12 — Reel NOT RETRIEVED

  • Conveyance: Change of Address of Assignee (not an ownership transfer)
  • Assignor: BANYAN BIOMARKERS, INC.
  • Assignee: BANYAN BIOMARKERS, INC.
  • Correspondent: NOT RETRIEVED. (Prosecution agent of record on the patent is Oliff PLC, Alexandria VA — this is the prosecution correspondent, not confirmed as the assignment correspondent.)
  • Context: Administrative change‑of‑address filing; ownership unchanged — Banyan still held title.

• Executed: NOT RETRIEVED / recorded 2026‑01‑13 — Reel NOT RETRIEVED

  • Conveyance: Assignment of Assignor's Interest
  • Assignor: BANYAN BIOMARKERS, INC.
  • Assignee: bioMérieux, Inc.
  • Correspondent: NOT RETRIEVED.
  • Context: Corporate acquisition — Banyan's TBI biomarker patent family transferred to the operating IVD acquirer bioMérieux. Recorded ~3 months before the patent granted (2026‑04‑14).

Corporate/context anchors for these dates: bioMérieux's 2024 and 2025 shareholder materials and its FY2025 results (published 27 Feb 2026) document an active acquisition program; the Banyan relationship is a long‑standing partnership (2017 equity investment → title consolidation by 2026). No 10‑K/8‑K from a public US assignor is available because Banyan was private.

If a third (earlier) assignment exists — e.g., inventor→Banyan recorded at national‑phase entry in 2011 — it did not surface in the legal‑events register I could read and is marked NOT RETRIEVED.

Timeline diagram

timeline
    title Ownership of US 12601749
    2008 : Priority filing by Banyan Biomarkers
    2009 : PCT application filed by Banyan
    2011 : US national phase entered
    2024 : Continuation filed by Banyan
         : Change of address recorded 12 Nov 2024
    2026 : Assignment to bioMerieux 13 Jan 2026
         : Patent granted 14 Apr 2026

NPE / troll‑pattern signals

1. Shell‑entity transfer — not present. The only ownership transfer runs Banyan Biomarkers, Inc. → bioMérieux, Inc. (recorded 2026‑01‑13). bioMérieux is a publicly listed French in vitro diagnostics operating company (€4.07B FY2025 sales), not a licensing‑only LLC. No "IP/Holdings/Ventures" suffix, no registered‑agent address, no single‑purpose entity.

2. Known asserter in the chain — not present. Neither assignor nor assignee matches any of the listed NPE directories (Acacia, Marathon, IV, Wi‑LAN/Conversant, Vringo, Pendrell, Round Rock, etc.). No entity surfaced by RPX or Unified Patents appears in the retrieved chain.

3. Repeat correspondent across the chain — unclear / NOT RETRIEVED. I could not obtain the assignment correspondent on either recorded event, so recurrence cannot be tested. The only correspondent I can identify is the prosecution agent Oliff PLC (per PatentGuru) — a general‑practice IP firm, and a single appearance is not a finding in any event. Flag for follow‑up: pull the correspondent name on both reel entries at the Assignment Center.

4. Cascading transfers — not present. Only two events over ~14 months, and one is a change‑of‑address with no change in ownership. There is no chain of LLCs, no common‑principal pattern.

5. Pre‑litigation transfer — not present. I found no infringement suit naming this patent. The 2026‑01‑13 transfer predates grant (2026‑04‑14) as part of a corporate acquisition, not a pre‑suit venue/standing maneuver.

6. Bankruptcy fire‑sale — not present (with a caveat). No Chapter 7/11, no auction, no assignment‑in‑bankruptcy. Banyan was a venture‑/grant‑funded private company acquired in an ordinary‑course M&A transaction. Caveat: Banyan's private status means a distressed sale would not appear in SEC filings; absence of evidence is noted but not dispositive.

7. Privateering — not present. No operating company transferring to an NPE to assert against competitors. The transfer is to the operating company that commercializes the claims.

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

Verdict

Operating‑company assertion (closest fit; see caveat).

The chain terminates at bioMérieux, Inc., a large operating IVD manufacturer that ships a product embodying claims 1–14 (VIDAS® TBI GFAP/UCH‑L1, CE‑marked 2023, FDA 510(k) 28 May 2024). The single recorded ownership transfer (Banyan → bioMérieux, recorded 2026‑01‑13) is an ordinary corporate acquisition, preceded only by a change‑of‑address entry (recorded 2024‑11‑12) that did not move title. No NPE signal is present on any of the eight tests.

Caveat on the label: the category "Operating‑company assertion" nominally requires the owner to be suing competitors, and I found no litigation. Read literally, the evidence supports the narrower conclusion of operating‑company ownership with no NPE indicators, rather than demonstrated assertion. I selected this bucket because it is the only non‑NPE, non‑defensive option available and the product/commercialization prong is satisfied.

To close the remaining gaps, verify at the Assignment Center (https://assignmentcenter.uspto.gov/ and https://assignment.uspto.gov/patent/index.html): (a) the reel/frame of the 2026‑01‑13 assignment; (b) the assignment correspondent on both entries; (c) any inventor→Banyan assignment recorded around 2011 national‑phase entry; and (d) confirm there is no separate security‑interest or license record (bioMérieux's 2017 equity/rights agreement could have generated a recorded license).

I'll search for this specific patent and its prior art references.

Let me gather details on the key cited references and the prosecution history.

Identification of the Patent (literal)

This is a continuation of US 16/890,943 (issued as US 11,994,522 B2), itself a continuation of 15/709,368 (US 2018/0031577 A1) → 13/058,748 (US 2011/0143375 A1) → national phase of PCT/US2009/053376 (WO 2010/019553 A2). The European sibling EP 09807153.3 (EP 2324360 B1) was opposed, revoked (decision 2021‑07‑15; revocation effective Dec. 2023).

Note on the fetched text: claim 4 recites "bloom serum," and the KIPO search report transcript renders the assignee as "BAWYAN BIOMARKERS." Both appear to be OCR/transcription artifacts in the source; I flag rather than silently correct them.

Legal framework applied

Critical date: 2008‑08‑11. Because the granted claims depend on the 2008 priority chain, pre‑AIA §102 applies to art predating that date. For §102 anticipation, a single reference must disclose every element of the claim, arranged as claimed. The independent claims here are narrow and each contains four conjunctive limitations:

1. Both GFAP and UCH‑L1;
2. in blood/plasma/serum;
3. collected within 12 hours of the TBI/suspected TBI; and
4. a TBI/GCS (13‑15 or 9‑12) and a head‑CT performance-or-declination decision (claims 1, 9, 10, 11), or at minimum an assay after TBI (claim 5).

Important caveat: I do not have the file wrapper (office actions/PTA) for 18/637,770. The analysis below is built from the 119‑reference citation list on the published record and the family's examination history (the PCT/KIPO search reports for WO 2010/019553 and the related WO 2011/160096), not from a §102 rejection in this specific continuation.

Tier 1 — Examiner‑cited "X" (anticipation‑category) references in the family

These two were flagged "X" (i.e., anticipatory of the then‑pending broader claims) in the international search report for PCT/US2009/053376 (https://patentimages.storage.googleapis.com/8b/89/14/a341041efb2624/WO2010019553A3.pdf):

1. US 2005/0260697 A1 — Wang, Hayes, Liu, Oli

• Full citation: "Proteolytic markers as diagnostic biomarkers for cancer, organ injury and muscle rehabilitation/exercise overtraining," US 2005/0260697 A1; App. 11/106,932 filed 2005‑04‑15; published 2005‑11‑24; priority US 60/562,819 (2004‑04‑15); assignee Univ. of Florida Research Foundation; granted as US 7,456,027 B2 (2008‑11‑25).
• Description: Detects proteolytic‑enzyme biomarkers and their substrate proteins in biological fluids after neural/organ injury. Explicitly lists UCH‑L1 (Q00981) as a "somal protein" substrate and GFAP (P47819) as a "glial protein" substrate, and claims detection of "at least two," "at least three," etc. biomarkers (claims 19–23). The KIPO ISR cited it as X against PCT claims 17–30.
• Potentially anticipates: On the PCT claim set, claims 17–30 (multi‑biomarker neural‑injury diagnosis). Against the issued claims 1–14, it discloses elements (1) UCH‑L1 + GFAP and (2) biological‑fluid assay, but not the 12‑hour window, the GCS 13‑15/9‑12 limitation, or the CT decision — so it does not appear to anticipate any of the 14 issued claims on its face. Strongest relevance is now §103.

2. EP 1519194 A1 — Roche Diagnostics GmbH (Sitzer)

• Full citation: "Use of GFAP for identification of intracerebral hemorrhage," EP 1519194 A1; priority 2003‑09‑24; published 2005‑03‑30; US sibling US 2006/0240480 A1, granted as US 10,794,918 B2.
• Description: Measuring GFAP in whole blood/serum/plasma within 6 hours of stroke onset, by sandwich immunoassay or test strip (LOD 3 pg/mL), using a cut‑off to classify intracerebral hemorrhage vs. ischemic stroke. KIPO ISR cited it as X against PCT claims 31‑34.
• Potentially anticipates: PCT claims 31–34. Against issued claims: discloses (2) blood sample, (3) an even shorter time window, and (4) a cut‑off‑driven clinical decision — but only GFAP (no UCH‑L1) and stroke (not TBI/GCS/CT). Does not anticipate claims 1, 5, 9, 10, or 11; relevant for §103 (motivation to combine a GFAP cutoff assay with a second neural marker).

Tier 2 — Other §102‑eligible cited art (all predate 2008‑08‑11 unless noted)

Key non‑patent literature cited (all predate the critical date): Pelinka et al., J Trauma 57:1006‑1012 (2004) (GFAP/S100B after trauma); Meric et al., J Emerg Med 38(3):297‑301 (Epub 2008‑05‑22); Romner et al., J Neurotrauma 17:641‑647 (2000) and De Kruijk et al., Acta Neurol Scand 103:175‑179 (2001) (S‑100B/NSE in mild TBI); Huh et al., J Neurotrauma 20(10):975‑984 (2003); Zhang et al., J Forensic Med 22(2):88‑92 (Apr. 2006) (certified translation); Aurell et al., Stroke 22(10):1254‑1258 (1991) (GFAP/S‑100 in CSF post‑infarct); Baldwin et al., Glia 16(3):266‑275 (1996); Herrmann et al., Stroke 31:2670‑2677 (2000); van Geel et al., Clin Chim Acta 326:151‑154 (2002); Niebroj‑Dobosz et al., Folia Neuropathol 32:129‑137 (1994); Dambinova et al., Clin Chem 49(10):1752‑1762 (2003); Del Prete et al., Thromb Haemost 95(1):22‑28 (2006) (cited "A"). These are §102(b)/§103 art for individual biomarker‑elevation concepts but none discloses the GFAP+UCH‑L1/12‑h/GCS/CT combination.

Tier 3 — Cited art that is NOT §102 prior art here (post‑2008‑08‑11)

These appear in the "Cited By" list but cannot anticipate (or render obvious under pre‑AIA §102) any claim entitled to the 2008 priority date:

• Abbott Laboratories: US 10,849,548 B2, US 10,877,048 B2, US 10,877,038 B2, US 11,016,105 B2, US 11,022,617 B2, US 11,022,617 B2 — all priority 2017 (GFAP+UCH‑L1 for TBI evaluation). These are the closest disclosure of the issued claim concepts (UCH‑L1+GFAP, hyperacute windows, cutoff values) but post‑date the priority date by ~9 years.
• Banyan's own later filings: WO 2018/081649 A1, US 10,078,298 B1 family (anti‑UCH‑L1/anti‑GFAP antibodies).
• WO 2015/157300 A1 (Iron Horse Diagnostics); WO 2015/157390 A9 (Univ. of Florida); WO 2013/040502 A2 (Henry M. Jackson Foundation); US 10,041,959 B2 (Banyan).
• Berger et al., J Neurotrauma 29(1):162‑167 (2012).

Bottom line on anticipation (§102)

• No single reference in the cited record discloses every element of issued claims 1, 5, 9, 10, or 11 (GFAP and UCH‑L1, blood, within 12 hours, plus the TBI/GCS/head‑CT decision). Accordingly, on the face of the record, none of the 119 citations anticipates any of the 14 issued claims, and the two "X" references (Wang '697; Roche EP 1519194) were directed at broader claims in sibling family members, not at the present claim set.
• The references that come closest on the measuring limitation are US 2005/0260697 A1 (GFAP + UCH‑L1 in biological fluid; §103) and, for the blood/12‑h/cutoff limitations, EP 1519194 A1 / US 10,794,918 B2 (§103 for GFAP; no UCH‑L1).
• If the 2008 priority were ever lost or narrowed, the Abbott GFAP/UCH‑L1 patents (2017) would be the most dangerous art — but they cannot be §102 prior art for a claim entitled to 2008‑08‑11.
• Context worth weighing: the European counterpart EP 2324360 was opposed and revoked (opposition filed 2018‑10‑31 by "TAYLOR"; decision 2021‑07‑15; revocation Dec. 2023; appeal file noted at Justia for US 12,077,601 — https://patents.justia.com/patent/[12077601](/patent/12077601)#43; status page https://ipverse.greyb.com/patent/EP2324360). That outcome signals the family's broader claims were vulnerable to art including the Wang '697/‘654 and Roche GFAP references discussed above.

Confidence note: I am confident about the citations, dates, and descriptions above (grounded in the sources linked). I do not have the actual office actions or the notice of allowance for application 18/637,770, so I cannot state which specific reference (if any) the examiner relied on for this continuation; that should be verified in USPTO Patent Center.

Primary sources: https://patents.google.com/patent/US12601749/en · https://patents.justia.com/patent/[11994522](/patent/11994522) · https://patents.google.com/patent/US20110143375A1/en · https://patentimages.storage.googleapis.com/8b/89/14/a341041efb2624/WO2010019553A3.pdf · https://patentimages.storage.googleapis.com/79/12/ba/10ea19dd0a4204/WO2011160096A3.pdf · https://www.freepatentsonline.com/y2006/0240480.html · https://patents.justia.com/patent/[10794918](/patent/10794918) · https://www.patents-review.com/a/20050260697-proteolytic-markers-diagnostic-biomarkers-cancer-organ.html · https://patents.google.com/patent/JP4885122B2/en · https://ipverse.greyb.com/patent/EP2324360

I'll verify a few load-bearing facts about the prior-art references and check for art that bears on the head-CT decision step before building the § 103 analysis.

Obviousness of U.S. 12,601,749 under 35 U.S.C. § 103

*Built on the Prior Art section already produced for this patent. I do not repeat its reference-by-reference listings; where I add references or facts, they are marked as supplemental (verified in this session). I flag one conditional tension with the earlier sections at § 7.*

1. Framework and critical dates

Governing law — pre-AIA § 103(a), as construed by KSR. If the claims are entitled to the 2008‑08‑11 priority date (provisional 61/188,554) through PCT/US2009/053376, this is a pre-AIA patent and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), governs (decided April 2007, before the priority date). Graham v. John Deere factors apply; the Board/court asks whether the subject matter as a whole would have been obvious at the time the invention was made to a POSA, with the claims given their ordinary pre-AIA construction.

Prior-art categories and critical dates (pre-AIA).

POSA definition. A physician-scientist or clinical-chemist with an M.D. or Ph.D. in neuroscience/clinical chemistry and 3–5 years of experience in TBI/cerebrovascular biomarker research and emergency-medicine diagnostics. KSR cautions against over-credentialing the POSA; this is a skilled, not a visionary, artisan.

One structural point that drives everything below. The specification expressly incorporates US 7,291,710 and US 7,396,654 (both University of Florida Research Foundation neural-protein biomarker patents, owned in the same inventor lineage) by reference. The applicant's own disclosures are therefore an admission that the neural-protein biomarker concept — and, in US 7,396,654, the GFAP/UCH-L1-type protein panel in biological fluids for TBI — was known work.

2. The claim element matrix

Every independent claim collapses into four substantive limitations. This is the matrix I test the art against.

Dependents 2–4, 6–8, 12–14 add only GCS 13‑15 (2, 6, 12), plasma (3, 7, 13) or serum (4, 8, 14) — the claim 4 "bloom serum" string is the OCR artifact already flagged in the earlier sections and is read as "blood serum."

Two claim-construction observations that matter for § 103:

1. Claim 1's decision step is "GFAP and/or UCH‑L1." The UCH‑L1 result is therefore functionally optional for the outcome branch — a single marker exceeding the cutoff suffices to trigger the CT. (Claims 9 and 10, by contrast, recite "the levels of UCH‑L1 and GFAP … exceed," i.e., conjunction.) This matters: art teaching a GFAP-only cut‑off triage rule reaches the decision step of claim 1 directly.
2. "Predetermined cutoff values" is functionally claimed. The scope therefore reads on any threshold, including thresholds disclosed in the art.

3. The art set, and what each element it supplies

I take the Prior Art section's Tier 1/Tier 2 references as given and add the CT‑triage literature, which the earlier section's citation record did not fully mine.

3.1 Wang et al., US 2005/0260697 A1 (pub. 2005‑11‑24) — § 102(b)

Verified primary text (https://patentimages.storage.googleapis.com/8d/06/dd/cf090313ca53b7/US20050260697A1.pdf):

• Claim 4 names UCH‑L1 (Q00981) as a "somal protein" substrate; claim 8 names GFAP (P47819) as a "glial protein" substrate.
• Claims 19–23 recite detection of "a plurality," "at least two," "at least three," "at least four" of the biomarkers, and "any combination of at least two biomarkers … for diagnosing neural injury and/or neuronal disorders."
• The specification states brain-specific/enriched proteins "are released into the extracellular space and then released into the CSF and blood," that markers are preferably "detected during the early stages of injury," and — decisively for motivation — that "CT and MRI are expensive and cannot be rapidly employed in an emergency room environment," and that in combat "accurate diagnosis of TBI would be an essential prerequisite for appropriate triage of casualties."

Supplies: L2 (GFAP + UCH‑L1 as a two-marker neural-injury panel), L3 (blood; early), and the express motivation for a rapid blood-based triage surrogate for CT.

3.2 Sitzer / Roche Diagnostics, EP 1519194 A1 (pub. 2005‑03‑30; US sibling US 2006/0240480 A1, granted as US 10,794,918 B2) — § 102(b)

Verified text (https://www.freepatentsonline.com/y2006/0240480.html):

• GFAP measured in whole blood / serum / plasma and preferred "within the time-frame of 6 hours after on-set of disease."
• A hard cut‑off ("a GFAP level of above or equal to 3 pg/ml versus a GFAP level below that threshold") is used to classify patients.
• GFAP "appears to be released almost immediately … and has been found to be elevated for at least 24 hours."
• The reference frames the result instrumentally: "this invention will help to guide physicians … to select further appropriate diagnostics," and it expressly contemplates "a marker panel … comprising GFAP and one or more markers" on a test strip.

Supplies: L3's matrix and the hyperacute sampling concept (6 h is a species of "within 12 h" — performing at ≤6 h literally satisfies the claim), and the cut-off-driven clinical-decision architecture of L4.

3.3 Supplemental (verified this session) — the "blood marker → head CT" art, all pre‑2008‑08‑11

This is the piece the earlier Prior Art section under-weighted, and it is what converts the CT step from an open gap into a routine design choice:

Supplies: L1's GCS bands (CCHR uses GCS 13–15 as "minor head injury"; the S100B literature uses GCS 14–15 and, in the Scandinavian Neurotrauma Committee framework, GCS 9–15), and L4's binary "CT / no CT" decision, already taught to be driven by a blood astroglial marker.

3.4 The remaining Tier‑2 references from the prior-art section

• US 7,396,654 B2 and US 7,291,710 B2 — incorporated by reference into the '749; neural proteins and SBDPs in biofluids after TBI.
• Jackowski, US 2003/0040660 A1 (2003) — TBI diagnosis from blood markers with diagnostic devices/cutoffs.
• Biosite, WO 2003/016910 / WO 2004/059293 / US 2004/0121343 — multi-marker panels for cerebral injury.
• Pelinka et al., J Trauma 57:1006‑1012 (2004) — GFAP/S100B after trauma; Huh et al., J Neurotrauma 20(10):975‑984 (2003); Romner et al., J Neurotrauma 17:641‑647 (2000); De Kruijk et al., Acta Neurol Scand 103:175‑179 (2001).

4. The combinations

Combination 1 (primary) — Wang '697 in view of Roche '194 → reaches claims 1 (partial), 5, and 11 (partial)

What it teaches. Wang '697 gives the two-marker neural panel in blood (GFAP + UCH‑L1) and the express reason to build a rapid triage blood test because CT/MRI are "expensive and cannot be rapidly employed in an emergency room environment." Roche '194 gives the working prototype: a blood GFAP immunoassay, readable within 6 hours, with a validated threshold, explicitly deployed to "select further appropriate diagnostics," and explicitly extensible to a "marker panel."

Motivation to combine (KSR factors):

• Same field, same problem, same solution type. Both address early detection of acute brain injury from a biofluid to guide downstream care.
• Express motivation to combine. Wang '697's claims 19–23 direct the artisan to detect a combination of its listed substrates; Roche '194 expressly claims the right to add "one or more markers" to GFAP on a test strip. The combination is not merely suggested — it is recited in both references.
• Reasonable expectation of success. Both markers are known brain-derived proteins released to blood; both antibodies and sandwich ELISAs were commercially available; Roche had already reduced the GFAP blood assay to practice.
• KSR "finite number of identified, predictable solutions." Wang '697 enumerates the candidate substrates. Selecting the glial marker (GFAP) plus the neuronal cell-body marker (UCH‑L1) covers the two principal injury compartments — precisely the rationale Wang '697's own claim 23 endorses ("any combination of at least two biomarkers").
• No teaching away. Nothing in either reference disparages the combination.

Combination 2 — Combination 1 in view of Müller 2007 / Biberthaler 2006 / Stiell 2001 → reaches claims 1, 9, 10, 11, and dependents 2/6/12

This adds the L4 imaging decision.

• Motivation to substitute GFAP (or GFAP + UCH‑L1) for S100B. Müller and Biberthaler teach that a serum astroglial protein measured after minor head injury predicts CT findings and "might support selection of patients for CT scanning." Roche '194 independently teaches that GFAP is a blood-measurable astroglial protein with higher brain specificity than the existing markers (the reference stresses "no false positive GFAP values" in the ischemic cohort). Substituting the more specific known glial marker for the less specific one, in the identical CT-triage use, is textbook obvious substitution of one known element for another, with predictable results. The '749's own specification supplies the missing rationale — "GFAP is [a] highly brain specific protein that is not found outside the CNS" — which is exactly the property a POSA would want over S100B (whose extracranial-injury interference was the recognized weakness of the S100B approach).
• Express teaching of the "decline the CT" branch. The S100B literature's entire point is rule-out/NPV — normal marker → avoid CT. That is claim 10 verbatim, and the "declining" branch of claim 1 and claim 11.
• The GCS bands are the art's own. CCHR (Stiell 2001) defines its population as minor head injury with GCS 13–15; the SNC framework spans GCS 9–15. Claim 1's "mild = GCS 13–15, moderate = GCS 9‑12" is a claim-embedded adoption of the art's existing severity taxonomy, not an inventive contribution.

Combination 3 — Combination 1 or 2 in view of Jackowski '660 and Biosite WO 2003/016910 → supplies TBI specificity and the multi-marker panel form

Jackowski supplies the "diagnose/distinguish traumatic brain injury from a blood sample with cutoffs and a device" framing; US 7,396,654 (incorporated by reference into the '749) supplies the GFAP/UCH‑L1-type neural-protein panel for TBI; Biosite supplies the accepted practice of running cerebral-injury marker panels. Together they close any residual gap on L1 (TBI population) and on the assay-format question.

Combination 4 — the same art applied to the routine limitations (dependents 3/7/13 and 4/8/14)

Roche '194 expressly recites "whole blood, serum, plasma"; Wang '697 recites "biological fluids." Serum and plasma are ordinary fractions of whole blood, and the '749's own Example 1/Example 7 describe making the assay work in serum as a matter of routine. In re Rosselet/KSR predictable-variation analysis disposes of these dependents.

§ 103(c) does not rescue the applicant

Wang '697 and US 7,396,654 are University of Florida Research Foundation filings; EP 1519194 is Roche's. Even assuming (without conceding) some common ownership with Banyan at the time of invention, § 103(c) disqualifies art only under § 102(e)/(f)/(g). Wang '697 and Roche '194 are § 102(b) publications (2005), and § 103(c) cannot touch § 102(b) art. The primary combination is therefore immune to the common-ownership defense.

5. Claim-by-claim conclusion

Overall § 103 posture (assuming the 2008 priority holds): every claim is vulnerable, but the art is strongest on claims 5, 9, 10 and 1/11's decision step, and weakest on claim 1's conjunctive two-marker measuring step combined with a 12‑hour window in a mild-to-moderate population — which no single reference discloses. There is no clean § 102 anticipation (consistent with the prior-art section's finding); the case is a § 103 case, and it is a strong one on KSR grounds.

6. What the patent owner will argue, and how it fares

A. "Unexpected synergy of GFAP + UCH‑L1." The specification asserts a "synergistic result." Three problems: (i) the assertion is conclusory relative to the data (FIGS. 9–15 are dominated by severe TBI, which the issued claims exclude); (ii) each marker was independently known to rise after neural injury, so the combination's benefit is the ordinary sensitivity gain a POSA expects from paneling; (iii) the specification's Example 11 (mild/moderate cohort) reports the markers rising in parallel across control/mild/moderate, which is additive, not synergistic. In re Merck / Pfizer v. Apotex line: a synergy argument requires comparative data against the closest single-marker practice, which does not appear in the record I have.

B. "Criticality of the 12‑hour window." Not critical — the art already teaches 6 hours (Roche '194) and 3 hours (the Scandinavian S100B protocol referenced in the Müller/Biberthaler work). A narrower disclosed window satisfies the broader claimed window and cannot be an inventive step.

C. "Teaching away." Müller's caution ("determination of serum S100B cannot replace the clinical examination or use of CT") will be cited. It fails: that sentence counsels against omitting CT in an undifferentiated population; the same paper says adding the marker "might support selection of patients for CT scanning." That is teaching toward, not away.

D. "Secondary considerations." The FDA De Novo for the Banyan Brain Trauma Indicator (2018) and the bioMérieux VIDAS TBI clearance are real, and if the patent owner can establish nexus to the claimed GFAP + UCH‑L1 blood combination within 12 hours, this is the applicant's best evidence. Counterweights: (i) the regulatory milestone is a decade after the priority date; (ii) two independent labs (Banyan and Abbott — Abbott's US 10,877,038 / 10,877,048 / 10,849,548 / 11,016,105 / 11,022,617 family, all 2017 priority) arrived at the same GFAP + UCH‑L1 blood combination, and simultaneous independent invention is itself evidence of obviousness; (iii) any nexus must run to the claimed combination, not to the underlying 2008 discovery of UCH‑L1 in blood.

E. "The art does not teach UCH‑L1 in blood." This is the applicant's strongest technical point and it deserves respect. But Wang '697 states that its brain-specific substrates "are released into the extracellular space and then released into the CSF and blood," and claim 4 puts UCH‑L1 squarely within that class. That is a § 103-grade teaching, even if the pre‑2008 literature had not yet reported a clinical serum UCH‑L1 dataset. (Note that the earliest human serum UCH‑L1 demonstration — Papa et al., Crit Care Med 2010, and the follow-on 2012 mild/moderate study — post-dates the priority date and is not available as art unless priority is lost; see § 7.)

F. § 101 overlay (not § 103, but relevant to claim 1's step (iii)). The "perform / decline a head CT" step, at bottom, is a physician's mental or clinical decision implemented on a known correlation. A court is unlikely to credit that step as the inventive contribution for Graham factor analysis; its presence mainly creates a Mayo/Alice problem for the patent owner rather than a nonobviousness shield. It also cannot supply novelty over a CT-decision rule that the art already taught.

7. The conditional that changes everything — priority (flagged, not a contradiction)

The earlier sections correctly state that this is a pre-AIA patent to which PGR is unavailable and CBM has sunset, leaving IPR (patents and printed publications only, § 311(b)) as the sole AIA vehicle, and that the priority question is the highest-leverage technical issue. I agree, and the § 103 analysis makes the stakes concrete.

If any one of claims 1–14 loses the 2008‑08‑11 benefit for the "within 12 hours," "GCS 9‑12 / 13‑15," or cutoff limitations (the file wrappers for 18/637,770, 16/890,943, 15/709,368 and 13/058,748 must be checked in USPTO Patent Center), the art set expands catastrophically:

• Papa et al. (2010 Crit Care Med; 2012 J Trauma Acute Care Surg — "Serum levels of ubiquitin C-terminal hydrolase distinguish mild traumatic brain injury from trauma controls and are elevated in mild and moderate traumatic brain injury patients with intracranial lesions and neurosurgical intervention") reports serum UCH‑L1 in GCS 13–15 and 9–12 patients within 4 hours, with CT-positive/CT-negative and neurosurgical-intervention discrimination — i.e., a species of essentially the whole claim set.
• The Abbott family (2017 priority) discloses GFAP + UCH‑L1 in blood within hyperacute windows with cutoffs and CT-decision use — under AIA § 102(a)(2), and given that they were cited in this patent's own record, squarely on point.
• Banyan's own intervening publications (WO 2010/148391; WO 2011/011334; WO 2011/032155) become intervening art.
• And the AIA would then apply (effective filing date after 2013‑03‑16), which would re-open PGR — a conditional refinement of, not a contradiction to, the earlier sections' "PGR unavailable" conclusion, which is correct only so long as the 2008 benefit holds.

This is the difference between a § 103 case built on KSR-style motivation-to-combine reasoning (§ 4 above) and a § 103 case, or arguably a § 102 case, built on art that discloses the very limitations in terms.

8. Bottom line and recommended next steps

1. Verdict on the merits (priority assumed): Claims 1–14 would have been obvious under pre-AIA § 103(a). The load-bearing combination is US 2005/0260697 A1 (Wang — GFAP + UCH‑L1, blood, early, triage motivation) + EP 1519194 A1 (Roche/Sitzer — blood GFAP, 6‑h window, cutoff-driven clinical decision, marker-panel suggestion), with Müller 2007 / Biberthaler 2006 / Stiell 2001 supplying the marker→head‑CT decision in the GCS 13–15 minor-head-injury population. Both primary references are § 102(b) art and immune to the common-ownership exception.
2. The strongest claim to attack is claim 5 (simplest; the UCH‑L1 measuring step in blood is the only real issue) and claims 9/10/11 (the CT-decision claims, where the S100B literature is directly on point). Claim 1 is the hardest, because it conjoins the two-marker measuring step with the 12‑hour window and a mild/moderate population — attack it via the priority route first.
3. Do the priority check before drafting anything. Pull the file wrappers and map each of the 12‑hour, GCS 9‑12/13‑15, and cutoff limitations against the 2008‑08‑11 / 2008‑09‑17 / 2009‑06‑19 / 2009‑07‑18 provisionals. If support is missing, the Papa and Abbott art move in, and the case changes character.
4. Sequence the forum correctly. Because § 311(b) confines IPR to patents and printed publications, the Wang '697, Roche '194, Müller 2007, Biberthaler 2006 and Stiell 2001 references are all IPR‑eligible (each is a patent or printed publication). Anything premised on the 2007 Swedish clinical implementation of the S100B protocol or other foreign public use must be litigated in district court — pre-AIA § 102(a) "known or used" reaches only use in this country.
5. Then re-run the ODP/E2E and PACER checks as the earlier sections recommended; nothing in this analysis depends on, or supplies, any litigation or AIA‑proceeding number.

Confidence and limits. I am confident in the content of the references quoted (each is linked above) and in the KSR mapping. I do not have the file wrapper for 18/637,770 or any of its parents, so I cannot state which reference, if any, the examiner actually relied upon, nor whether the applicant made a priority‑preserving amendment; and my assessment of the priority question is an analytical hypothesis grounded in what the issued claims recite versus the 2008 provisional record I can see, not a verified finding. My searches for the Abbott filing/priority details and for the '522 patent's non‑patent citation list were cut off by search limits; treat those two items as unverified.