US 11402390

I'll search for this specific patent number and check for any litigation/docket activity.

Let me run a few more targeted searches on litigation and current ownership.

Let me check for any Federal Circuit or district court activity involving the patent owner.

Bottom line

I found authoritative bibliographic and full-text data for US 11,402,390 B2 (this is the patent whose text is reproduced in the source document above, matching exactly). I found no evidence of any 2026 CAFC appeal, IPR, or district-court case involving this patent number; my docket-oriented searches returned only unrelated matters (Cirba v. VMware, InterDigital v. Disney, Mitsubishi Tanabe v. Apotex, Site Sciences v. Alcon, etc.). Treat the "no litigation found" conclusion as a negative search result, not proof of absence — see the Uncertainty section.

Bibliographic summary

Source of record: https://patents.google.com/patent/US11402390/en

Abstract (as issued)

"The present invention relates to a reliable method of prediction of lower respiratory tract infection or inflammation in humans, wherein the level of pancreatic stone protein/regenerating protein (PSP/reg) is determined in serum, and a high level is indicative of the development and the severity of the disease, allowing the classification of patients according to risk."

Independent claims — plain-language overview

The patent has 12 claims, of which claims 1 and 12 are independent (claims 2–11 all depend from claim 1). Both independent claims are drafted as combined diagnostic-plus-treatment claims (detect biomarker → diagnose → administer antibiotic), a structure typical of post-Mayo/Alice drafting for biomarker inventions.

Claim 1 — "Detecting PSP/reg and treating VAP"

1. a) Sample collection: Obtain a body fluid sample from a patient. The timing is stated as optional — the claim recites "optionally on a day of VAP onset and/or on day 2, 3, 4, 5, 6 after the VAP onset and on day 7 after the VAP onset."
2. b) Detection: Determine whether PSP/reg is present in that sample — again "optionally" on the same set of days — in a quantity equal to or higher than 150 ng/ml.
3. c) Diagnosis: Diagnose the patient with VAP indicative of VAP-associated complications, and with "an odd ratio [sic] for the patient's mortality at day 7 to day 28 of 13.8 with a 95% confidence interval," when the day-7 PSP/reg quantity is ≥ 177 ng/ml.
4. d) Treatment: Administer an effective amount of an antibiotic to the diagnosed patient.

Note the internal threshold mismatch: step b) uses a 150 ng/ml threshold, whereas step c) is conditioned on 177 ng/ml at day 7. The two numbers come from different places in the specification (the 150 ng/ml value appears in the description's risk-stratification passages; 177 ng/ml comes from the ROC analysis at day 7, where the odds ratio for death by day 28 was 13.8, 95% CI 3.3–57.1). The word "odd ratio" (for "odds ratio") appears literally in the claim and should be read literally rather than auto-corrected.

Claim 12 — Variant without an explicit numeric detection threshold

Structurally parallel to claim 1, but:

• step b) merely requires determining whether PSP/reg is present in the sample (the "optionally"-timed days) with no ng/ml threshold recited;
• step c) diagnoses the patient with an odds ratio for VAP mortality at day 7 to day 28 of 13.8 (95% CI) when the day-7 PSP/reg quantity is ≥ 177 ng/ml;
• step d) again requires administering an effective amount of an antibiotic.

Dependent claims at a glance (all depend on claim 1)

• 2 — Sample is serum or plasma.
• 3 — Patient is human.
• 4 — PSP/reg is SEQ ID NO:1 (UniProt P05451, alpha) or SEQ ID NO:2 (UniProt P48304, beta).
• 5 — 180 ng/ml or more detected at VAP onset or on day 2, 3, 4, 5, 6, or 7.
• 6 — 150 ng/ml or more detected at VAP onset or on day 2.
• 7 — Patient is transferred to an intensive care unit.
• 8 — PSP/reg measured by ELISA, RIA, or EIA.
• 9 — Sandwich ELISA using a first and a second anti-PSP/reg antibody, one carrying a label, with microtiter plate coating/blocking/loading steps.
• 10 — Label is an enzyme for chromogenic detection.
• 11 — First and second antibodies are any combination of guinea pig, rat, mouse, rabbit, goat, chicken, donkey, or horse antibodies.

Prosecution, cited art, and family notes (relevant context)

• Continuation lineage: This patent issued from a continuation (15/911,347) of the abandoned US 13/701,433, itself a continuation of PCT/IB2011/052381. A further continuation, US 17/847,541 (US 2023/0019870 A1), was filed 2022-06-23 and is abandoned — so the claims in this patent appear to be narrower/differently scoped than what the family ultimately settled on elsewhere.
• Key prior art cited on the face of the patent (per the "Patent Citations" and "Non-Patent Citations" lists): WO 2009/030456 A1 and US 2010/0222223 A1 (Universität Zürich, "Method for assaying sepsis in humans"), US 2013/0165345 A1 (Universität Zürich, peritonitis), AU 2008295046 B2, US 5,789,261 A, US 6,309,888 B1, US 7,358,062 B2; and notably Boeck et al., "Pancreatic Stone Protein: a marker of organ failure and outcome in ventilator-associated pneumonia," Chest 2011;140(4):925-32 — which is the closest published work to the VAP subject matter claimed here.
• Assignment trail: Inventor assignments to Stepstone Diagnostics Sàrl (Lajaunias) and University Hospital of Basel (Stolz), effective June 2018; a merger of Sepstone Diagnostics Sàrl into Lascco SA (effective 2018-10-09) recorded 2022-06-23; address changes recorded 2022-06-23 and 2023-02-16.
• Commercial context (informational only, not legal status): Lascco SA (Lausanne, Switzerland) licenses the PSP biomarker to Abionic SA, whose abioSCOPE-based IVD CAPSULE PSP received FDA 510(k) clearance in late 2024; a China-market license to Fapon Biotech was announced in October 2023. See https://www.biopole.ch/wp-content/uploads/2023/10/[231026](/patent/231026)-PR-LASCCO-FINAL-Fapon-Abionic-Lascco-PSP.pdf and https://www.vischer.com/en/knowledge/deals-cases/4/?tx_llcatalog_pi%5Bdeals-and-cases%5D=32453

Litigation / CAFC 2026 docket search — result

No hits. My targeted searches for "11402390" / "11,402,390" combined with Federal Circuit and docket terms returned zero results for this patent. The only patent-litigation material returned was unrelated (e.g., Cirba Inc. v. VMware, InterDigital v. Disney, Mitsubishi Tanabe v. Apotex, Site Sciences v. Alcon, Vervain v. Phison). I found no IPR, PGR, reexamination, ITC, or district-court record naming US 11,402,390, and no owner-vs-owner dispute between Lascco/Stepstone and Abionic — the public record instead shows them as licensing partners, not adversaries.

Explicit uncertainty / caveats

1. No authoritative USPTO Patent Center or PACER/Docket confirmation. I could not directly query Patent Center (application 15/911,347) or a PACER docket for this number within this session. The bibliographic data above comes from the Google Patents record supplied to me and cross-corroborated by Justia (https://patents.justia.com/patent/[11402390](/patent/11402390)) and FreePatentsOnline for the sibling publication (https://www.freepatentsonline.com/y2023/0019870.html).
2. "Current assignee" is flagged as unreliable by the source itself. The Google Patents listing explicitly warns that assignee listings "may be inaccurate." The contemporaneous assignment records show transferred interests flowing to Lascco SA, which is the entity named in the 2022 merger and 2023 address-change records.
3. Absence of litigation is not verified absence. Docket searches via general web search are not a substitute for a comprehensive LexisNexis/Docket Navigator/PACER inquiry; a quietly filed or recently filed 2026 case could exist without indexed web coverage.
4. Claim-language oddities are reproduced verbatim, not corrected: the "optionally" qualifiers in steps (a) and (b) of claims 1 and 12, the 150 vs. 177 ng/ml threshold divergence, and the "odd ratio" spelling all appear as written in the issued claims.
5. The abstract, specification, and Figure 3 discussion contain their own internal numerical discrepancies (e.g., Figure 3's description states 177 ng/ml at day 7 gave 54% sensitivity/90% specificity, while the corresponding Example text states 58% sensitivity/91% specificity, with "Positive and negative predictive values" given as 54% and 90%). I have not attempted to reconcile these; I note them because they affect how the claim-1 "odds ratio of 13.8" limitation reads against the disclosure.

I'll search for litigation involving US patent 11402390 across multiple sources.

Initial searches returned irrelevant results. Let me try more targeted sources.

Let me search more targeted litigation databases.

Litigation Search Results: US Patent 11,402,390

Bottom line: Based on my searches, I found no known litigation involving US Patent 11,402,390. I want to be explicit that this is a "no results found" answer, not a confirmation of a clean litigation history, for the reasons below.

What I searched

I ran targeted queries against patent-litigation-oriented sources (including Unified Patents' litigation portal, CourtListener, PACER/case-number lookups, and general web indexing), and specifically for the exact identifier variants:

• 11402390
• US 11,402,390 / 11,402,390
• Patent owner/assignee names: Lascco SA, University Hospital of Basel, StepStone Diagnostics Sarl
• The asserted-technology context: PSP/reg (pancreatic stone protein / regenerating protein) diagnostics and licensee/partner Abionic SA

Findings

1. No infringement suits, declaratory judgment actions, ITC investigations, or PTAB proceedings referencing US 11,402,390 appeared in any of the results I retrieved.
2. A potentially confusing false positive surfaced: Perceptix Technologies LLC v. Meta Platforms, Inc., Case No. 8:25-cv-02390 (C.D. Cal.). The "02390" there is a case number suffix, not the patent number — it is unrelated to US 11,402,390 and I did not count it.
3. The only enforcement/commercial activity located around this patent family is licensing, not litigation — e.g., the October 26, 2023 LASCCO/Abionic licensing agreement with Fapon Biotech for the PSP sepsis biomarker in China (Biopôle press release). Licensing activity can co-exist with, but is not evidence of, litigation.

Context that may be relevant (not litigation)

• US 11,402,390 is part of a family claiming priority to 2010-05-31 (provisional US 34990910P; PCT/IB2011/052381 → WO2011151783A1; EP2577316B1; US 13/701,433 abandoned; the application that matured into the '390 patent, US 15/911,347). Family members include EP2577316B1, DK2577316T3, ES2619569T3, and HU E032211T2, and a later continuation US 17/847,541 (US20230019870A1).
• The patent's cited prior art and the related Universität Zürich sepsis assays (WO2009030456A1 / AU2008295046B2, US20100222223A1; and the peritonitis case US20130165345A1) are the closest technical neighbors, but nothing I retrieved shows any of these being asserted against the '390 patent.

Important caveats

• My search coverage is not exhaustive. Free sources (Unified Patents portal, CourtListener, generic web search) may lag behind paid litigation databases (Lex Machina, Docket Navigator, Westlaw Litigation Analytics), and newly filed complaints — especially in state courts, foreign courts, or sealed actions — may not be indexed. A "no results" from these tools is not the same as a verified absence of litigation.
• I could not complete the full set of follow-up searches I intended (I hit a tool-step limit), so I cannot claim the search was comprehensive across PACER and every litigation aggregator.
• The assignee history is notable for potential standing/enforcement questions: the '390 patent was assigned from Lascco SA / University Hospital of Basel to StepStone Diagnostics Sarl (2018) and then to Lascco SA following a merger (recorded 2022). If you need a definitive litigation check, that chain, plus the Abionic/Fapon license, is the right place to focus diligence.

Recommendation: Treat this as "no litigation identified, unverified." If a definitive answer is required for a freedom-to-operate, due-diligence, or enforcement analysis, I'd recommend a direct PACER/CourtListener docket search on "11,402,390" and a check of Docket Navigator / Lex Machina for the assignee entities, plus a review of the EPO opposition file for EP2577316B1 (oppositions at the EPO are a common source of validity disputes for this family that would not appear as US "litigation").

I'll verify the structured "no proceedings" data point with targeted searches before writing this up.

Let me run two more targeted checks before concluding.

Proceedings overview

Total AIA trial proceedings on US 11,402,390: 0. The structured USPTO Open Data Portal block states plainly that the ODP API returns no AIA trial proceedings for this patent as of the most recent ingest, and my independent web searches (see "Verification performed" below) surfaced no IPR, PGR, or CBM naming this patent — so there is no breakdown to give (0 active / 0 invalidated / 0 sustained / 0 settled / 0 institution-denied), no judge panel, no FWD, no settlement, and no Federal Circuit appeal to report.

Bottom line for a defendant: the patent is neither hardened nor softened by PTAB action — it is completely untested. That is a materially different posture from "the patent survived two IPRs" and from "claims 1–5 were canceled." No claim has been canceled, so no patent-owner demand letter can be dismissed on the basis of a PTAB outcome; but equally, no petitioner has ever put the claims at risk, and every prior-art ground is still on the table with no statutory estoppel attached. If you are served today, you have a free first move that the patent owner has never had to defend against.

Proceedings on file

None. Per the constraints of this task, I will not fabricate proceeding numbers, panels, or dispositions. For completeness, the two near-miss search artifacts I hit are not this patent and are excluded from the count:

The trailing "402" digits are what pulled these up; none involves US 11,402,390.

Why this patent has likely never attracted a petition (analytical inference, not record evidence)

I want to be explicit that the following is my reasoning about incentives, not a documented finding:

1. Short remaining life. The patent's adjusted expiration is 2032-06-14 (per the structured data), with a 2010-05-31 priority. A petitioner weighing a ~USD 500k–1M IPR campaign against roughly six years of remaining term has a weaker business case than against a patent with 15 years left.
2. Licensing, not asserting, posture. The enforcement history visible in the public record is licensing — the LASCCO/Abionic partnership since 2015 and the 2023-10-26 Fapon license for China (https://www.biopole.ch/wp-content/uploads/2023/10/[231026](/patent/231026)-PR-LASCCO-FINAL-Fapon-Abionic-Lascco-PSP.pdf). IPRs overwhelmingly follow infringement suits. No public infringement suit = no IPR, almost mechanically.
3. The owners are a small Swiss biotech and a university hospital, not a litigation-funding-backed NPE with a dividend to defend.
4. The claims are drafted to be hard to attack in an IPR specifically. Claim 1 as issued is a detect → diagnose → administer antibiotic treatment claim. Its patentability weight rests heavily on the diagnosis-and-treatment steps and on clinical thresholds drawn from the inventors' own prospective study — subject matter that IPR cannot reach at all, because IPR is limited to § 102/§ 103 over patents and printed publications (35 U.S.C. § 311(b)). PGR, which could reach § 112 and § 101, expired 2023-05-02, nine months after the 2022-08-02 grant.

Strategic summary

Claim status: 100% UNTESTED. All twelve claims — independent claims 1 and 12, and dependent claims 2–11 — remain as issued on 2022-08-02. No claim of US 11,402,390 has been CANCELED, none has been SUSTAINED by a panel, and none has been construed by the PTAB under Phillips. For a defendant, the practical consequence is that there is no preclusive claim construction, no adverse-inference record, and no patent-owner-favorable FWD to work around. It also means you cannot determine from the PTAB record which of the 150 ng/ml versus 177 ng/ml limitations the owner treats as the inventive core — the owner has never had to commit to a position under oath.

Estoppel landscape: clean, in your favor. Because there has never been a petitioner, § 315(e)(2) estoppel attaches to no one. All prior art cited on the face of the patent remains available to you for a fresh § 102/§ 103 challenge: WO 2009/030456 A1 and US 2010/0222223 A1 (Universität Zürich, sepsis assays), AU 2008295046 B2, US 2013/0165345 A1 (Zürich, peritonitis), US 5,789,261, US 6,309,888, US 7,358,062, and the non-patent literature including Boeck et al., Chest 2011;140(4):925-32. To this I would add the following hypotheses for your counsel to verify, flagged as unverified:

• The Boeck et al. reference is co-authored by named inventor Daiana Stolz and reports the same VAP cohort, cut-offs, and mortality analysis as the specification. If Boeck et al. qualifies as prior art — which turns entirely on whether the challenged claims are entitled to the 2010-05-31 priority date — it is the single most dangerous reference in the file. The date math is uncomfortable: Boeck et al. published 2011-10-01 (Epub 2011-08-11), more than one year before the 2018-03-05 filing of the application that matured into this patent. Its status as prior art therefore hinges on the effective filing date of the specific claim limitation at issue, not on the patent's nominal priority claim. Whether the day-7/177 ng/ml or 150 ng/ml thresholds were supported in provisional US 61/349,910 is a question I cannot answer from the record in front of me, and it is the core priority/practice dispute I would diligence first.
• § 112 exposure on the issued claim language itself — the 150 ng/ml threshold in step b) versus the 177 ng/ml threshold in step c) of claim 1, the pervasively "optional" timing limitations in steps (a) and (b), and the literal "odd ratio … of 13.8" limitation are all candidates for written-description / indefiniteness attack. Note the asymmetry: these are district-court arguments, not IPR arguments. If the priority-date question goes badly for the patent owner, the same facts also feed a § 102(b) or § 102(a) attack on Boeck et al. in an IPR.
• § 315(b) and § 315(a)(1) clocks. If you (or a privy) were served with a complaint alleging infringement of this patent more than one year ago, you are time-barred from filing an IPR. If you have not yet been served, or were served recently, the one-year window from service is your principal deadline. Filing a declaratory judgment action of invalidity first triggers the § 315(a)(1) bar — sequence your filings accordingly.

Pattern signals: none exist. There is no repeat petitioner, no defensive aggregator (no Unified Patents, RPX, or IP Edge involvement that I could find), and no PTAB appeal history because there is no PTAB history. The patent owner has not pursued PTAB appeals aggressively because it has had nothing to appeal. This is the profile of a dormant, licensed, university-originated diagnostics patent, not an asserted one.

Verification performed

To avoid a false negative, I searched beyond the structured block for: the patent number in both 11402390 and 11,402,390 forms combined with PTAB/IPR/PGR/CBM terms; the patent owner and family names (Lascco SA, Stepstone Diagnostics Sarl, Sepstone Diagnostics Sarl, University Hospital of Basel) with PTAB terms; and PSP/reg-specific PTAB queries. All returned either nothing or unrelated patents. I also probed for a parallel EPO opposition to EP 2577316 B1 — the family's closest validity-forum analogue, and a common place for attacks that never surface as US "litigation" — and found no indexed opposition either. That negative is worth noting alongside the PTAB result, but carries the same caveat as the litigation section: an absence of indexed results is not verified absence.

Recommended next steps

1. If you are a defendant and time remains under § 315(b), the IPR door is wide open and there is no estoppel to inherit. Every ground you raise is fresh. Start with the § 102/§ 103 case built on Boeck et al. (2011) and the two Universität Zürich sepsis references, and brief the priority-date question as the threshold issue — if the 177 ng/ml and 150 ng/ml limitations are not supported by the 2010-05-31 provisional, Boeck et al. becomes § 102(b) art and claim 1 is seriously exposed.
2. Run the priority/§ 112 analysis in parallel and consider whether the district court, not the PTAB, is your best forum. Because IPR cannot reach § 101 or § 112, and because the treatment-step drafting of claim 1 signals that the applicant already fought an eligibility rejection during prosecution (the file history shows non-final actions on 2020-01-28, 2020-06-16, and 2021-09-27, followed by allowance on 2022-03-21, with two rounds of notice of allowance), the indefiniteness and eligibility theories are district-court-only levers that an IPR would forfeit. Request the full file wrapper via USPTO Patent Center for application 15/911,347 (https://patentcenter.uspto.gov) to see exactly what the examiner objected to and what arguments the applicant made.
3. If you are already time-barred under § 315(b), your validity case lives in the district court, and the Boeck et al. priority argument plus § 112 on the 150/177 mismatch becomes your centerpiece.
4. Verify the negative independently before relying on it. Confirm the absence of AIA trials directly at USPTO PTAB E2E / Patent Trial and Appeal Board End-to-End (https://ptacts.uspto.gov/ptacts/) by searching patent number 11,402,390, and confirm the Federal Circuit docket via CourtListener (https://www.courtlistener.com) and PACER. My conclusion of "no PTAB activity" is a negative search result, not a certified absence, and it should be independently verified before it is relied on in a due-diligence memo.

Explicit uncertainty statement: Consistent with the operating constraints, I have not invented a proceeding number, panel composition, institution decision, FWD disposition, settlement, or appeal. There is no such material to report. If a proceeding were filed after the ODP ingest date, it would not appear here.

I'll pull the recorded assignment data and cross-check ownership/entity details.

Assignment & Ownership Chain — US 11,402,390 B2

Source basis: the reel/frame citations below are reproduced from the Legal Events section of the fetched Google Patents record for US 11,402,390 B2, which mirrors the USPTO Assignment Center entries (reel/frame, conveyance, assignor, assignee, execution and recording dates). Gap I could not close: the correspondent-of-record (recording attorney/agent) field is not exposed in that rendering, and I was cut off before I could query Assignment Center directly. See signal #3 — this is the one field that would materially change the confidence of the NPE call.

Inventors

Pattern notes (and what is not a pattern):

• No inventor-departure signal. The two 2018 assignments were executed ~3.5 months after the 2018-03-05 filing and are classic confirmatory/clean-up assignments accompanying a continuation filing — not evidence of inventors leaving the original assignee. One of the two inventors (Lajaunias) is the assignee-side principal, so the assignment is not arm's-length.
• No evidence of any inventor transferring rights away from the family. I found no record of either inventor assigning to an unrelated third party.
• Spelling variance to read literally, not auto-correct: the official records themselves carry both "STEPSTONE DIAGNOSTICS SARL" (assignee on the 2018 assignment and applicant on US 2018/0259532 A1) and "SEPSTONE DIAGNOSTICS SARL" (assignor in the 2022 merger record and applicant on US 2013/0079296 A1). Both names appear as separate assignee entries on Justia (https://patents.justia.com/assignee/sepstone-diagnostics-sarl). Third-party reporting uses "Sepstone." I treat these as the same Geneva entity as recorded, but I am flagging the variance rather than silently normalizing it.
• Low-confidence, unverified: public reporting associates Daiana Stolz with a later move to the University Medical Center Freiburg (Germany). I could not verify that in this session and it is not relevant to the assignment chain — University Hospital of Basel remains the recorded assignee. Do not rely on it.

Original assignee

Lascco SA (Swiss commercial register CHE-113.456.410), originally Geneva, now Epalinges / Biopôle, Lausanne, Switzerland, co-listed with Universitaetsspital Basel USB (University Hospital of Basel).

• Primary line of business: an academic-technology development and licensing house, not a manufacturer. Founded 2007 by Samareh Azeredo da Silveira Lajaunias and Frédéric Lajaunias; takes licences on academic patents, funds development to clinical stage, and out-licenses to industry. Per its own description: "develop promising discovery-stage therapeutics and diagnostics stemming from research institute labs up to advanced clinical stage… critical care and emergency medicine" — https://www.biopole.ch/lascco-and-abionic-announce-a-licensing-agreement-with-fapon-for-psp-sepsis-diagnosis-in-china/
• Did it ship a product embodying the claims? Not directly. The commercial embodiment is third-party: Abionic SA's IVD CAPSULE PSP on the abioSCOPE platform (CE mark 2017; EU IVDR July 2022; TGA January 2023; FDA 510(k) clearance October 2024), and a Fapon Biotech CLIA reagent under an exclusive China licence (October 2023). Abionic has been "LASCCO's partner since 2015 for the development and commercialization of PSP." See https://www.biopole.ch/wp-content/uploads/2023/10/[231026](/patent/231026)-PR-LASCCO-FINAL-Fapon-Abionic-Lascco-PSP.pdf and https://www.360dx.com/point-care-testing/fda-clears-abionic-point-of-care-sepsis-test
• Current status: operating. Not acquired, dissolved, or in bankruptcy. PitchBook lists LASCCO with 15 total patent documents (https://pitchbook.com/profiles/company/[432697](/patent/432697)-51). The 4th-year maintenance fee on this patent was paid 2026-01-28 as a SMALL entity — consistent with Lascco still holding the patent and still qualifying as a small entity (no transfer to a large aggregator).
• Co-assignee: University Hospital of Basel — a public academic hospital, operating, non-commercializing. Its presence as a co-owner matters analytically (an academic co-owner is a practical brake on unilateral assertion).

Assignment timeline

Five recorded events exist for this family; only one changes ownership of the patent-in-suit (the 2018 merger). No post-issuance transfer of US 11,402,390 itself appears in the record.

1) 2018-06-19 (executed) / recorded 2018-06-26 — Reel 046197/0653

• Conveyance: Assignment
• Assignor: STOLZ, DAIANA
• Assignee: UNIVERSITY HOSPITAL OF BASEL (Switzerland)
• Correspondent: not exposed in the retrieved record — must be pulled from Assignment Center (this is the same gap flagged in signal #3).
• Context: confirmatory inventor-to-employer assignment executed ~15 weeks after the 2018-03-05 continuation filing.

2) 2018-06-20 (executed) / recorded 2018-06-26 — Reel 046197/0656

• Conveyance: Assignment
• Assignor: LAJAUNIAS, FREDERIC
• Assignee: STEPSTONE DIAGNOSTICS SARL (Geneva, Switzerland)
• Correspondent: not exposed in the retrieved record.
• Context: confirmatory inventor assignment to the Lascco-affiliated entity; assignee and assignor are the same economic interest (internal, not a sale).

3) 2018-10-09 (effective) / recorded 2022-06-23 — Reel 060284/0943

• Conveyance: Merger (absorption)
• Assignor: SEPSTONE DIAGNOSTICS SARL
• Assignee: LASCCO SA (Switzerland)
• Correspondent: not exposed in the retrieved record.
• Context: internal corporate reorganisation — Swiss merger of an affiliate into its parent. Corroborated by the Swiss Official Gazette (FOSC/SHAB, 12.10.2018): merger contract 08.10.2018, balance sheet 30.09.2018, assets CHF 176,398.93, third-party liabilities CHF 164,480.94, net assets CHF 11,917.99; Lascco held all quotas, so no capital increase and no share issuance — https://www.northdata.de/?id=6036661852
• Note the recording lag: executed 2018-10-09, recorded 2022-06-23 — i.e. the merger was papered only after the patent issued (2022-08-02 is the issue date; recording precedes it by ~6 weeks). This is late but unremarkable for a private Swiss group.

4) 2022-06-23 (executed) / recorded 2022-06-23 — Reel 060435/0317

• Conveyance: Change of Address (no ownership change) — Google Patents codes this under "AS / Assignment" but the free-format text reads "CHANGE OF ADDRESS;ASSIGNOR:LASCCO SA"
• Assignor: LASCCO SA — Assignee: LASCCO SA
• Correspondent: not exposed in the retrieved record.
• Context: purely administrative register update.

5) 2023-02-16 (executed) / recorded 2023-02-16 — Reel 062766/0705

• Conveyance: Change of Address
• Assignor: LASCCO SA — Assignee: LASCCO SA
• Correspondent: not exposed in the retrieved record.
• Context: purely administrative register update.

Not an assignment (do not count): the 2022-06-23 "priority to US 17/847,541" event is the filing of a further continuation (US 2023/0019870 A1), later abandoned — a prosecution event, not a conveyance.

Do not blindly trust the header. Google Patents' own banner warns assignee listings "may be inaccurate," and there is a genuine inconsistency worth stating: the pre-grant publication for this very application (US 2018/0259532 A1) lists applicants UNIVERSITY HOSPITAL OF BASEL and STEPSTONE DIAGNOSTICS SARL, whereas the issued patent lists Lascco SA and Universitaetsspital Basel USB. That shift is consistent with the merger (effective 2018-10-09) plus a subsequent assignee update — but note the merger post-dates the 2018-03-05 filing, so the applicant name on the publication was correct as of filing.

Timeline diagram

timeline
    title Ownership of US 11402390
    2010 : Priority date 31 May 2010
         : PCT filed by Lascco and UH Basel
    2018 : US continuation filed 5 March 2018
         : Stolz assigns rights to UH Basel
         : Lajaunias assigns rights to Stepstone
         : Sepstone Diagnostics merged into Lascco
    2022 : Patent US 11402390 issues 2 Aug 2022
         : Lascco SA records change of address
    2023 : Lascco SA records change of address
    2026 : Lascco SA pays 4th year maintenance fee

NPE / troll-pattern signals

Verdict

Defensive / non-asserting.

Justification. Ownership never leaves the original interest group: the sole ownership-changing record is reel 060284/0943 (merger, effective 2018-10-09), which moved rights from Sepstone Diagnostics Sàrl to Lascco SA, with the University Hospital of Basel remaining a co-owner per the confirmatory assignments at reel 046197/0653 and 046197/0656 (both recorded 2018-06-26). Every later record — reels 060435/0317 (2022-06-23) and 062766/0705 (2023-02-16) — is a change of address with assignor and assignee identical, and the 2026-01-28 maintenance fee was paid as a small entity, which is what one expects of a retained, non-aggregated portfolio. There is no known asserter, no chained shell LLC, no fire-sale, and no litigation; the patent is monetized through licences to a genuine product manufacturer (Abionic, FDA-cleared October 2024) rather than through suits.

Definitional caveat I want on the record: I am stretching the "Defensive / non-asserting" label slightly, because the strict definition contemplates a defensive aggregator at the end of the chain, which is not the case here. If your framework instead defines NPE purely as "non-manufacturing patent holder," then Lascco SA formally qualifies — it develops and licenses but does not itself ship an assay — and the verdict would shift to NPE — moderate confidence on the formal definition alone, with all eight troll-pattern signals nevertheless absent. On the evidence, no assertion-oriented signal is present.

Verify at: https://assignmentcenter.uspto.gov/ (search patent number 11402390) or the mirrored https://assignment.uspto.gov/patent/index.html. To fill the correspondent gap, query the assignment API for the five reels above — 046197/0653, 046197/0656, 060284/0943, 060435/0317, 062766/0705 — and pull the "correspondent" field from each record.

I'll research this systematically. I already have the authoritative full text of US 11,402,390 from the source document, so let me verify and gather details on each cited reference via USPTO and related databases.

Let me gather details on the remaining cited references, especially the Boeck et al. Chest 2011 paper (the closest art).

⚠️ Process note before the analysis: I hit the session's tool-call limit partway through verification. I completed searches on the '390 record itself plus US5789261A, US6309888B1, US7358062B2, WO2009030456A1/US20100222223A1, and the Boeck et al. Chest 2011 paper. My searches for US20070224638A1, WO2008021290A2, WO2008085601A2, US20130165345A1, and the remaining non-patent literature were cut off. For those I rely on the citation data printed on the face of US 11,402,390 itself (authoritative per the source document) and flag them as not independently re-verified in this session. I did not auto-correct any identifier.

Prior-art analysis — US 11,402,390 B2

0. Framing: what "anticipation" would require here

Both independent claims (1 and 12) are combined detect → diagnose → treat claims. For a single reference to anticipate under 35 U.S.C. § 102, it must disclose every element, arranged as claimed:

Because nearly all cited art predates the actual VAP + PSP/reg + threshold + antibiotic-treatment combination, and because most citations are directed at the generic immunoassay methodology or at PSP/reg in unrelated diseases (sepsis, pancreatitis, CAD, gastritis), no cited reference appears to anticipate claims 1 or 12 in their entirety. The real § 102 exposure is theoretical/priority-dependent (see § 4). Details and per-reference reasoning below.

1. The nine patent citations on the face of US 11,402,390

(Reproduced literally from the "Patent Citations (9)" list in the source document.)

2. Per-reference analysis

1) US5789261A — "Solid phase immunoassay" (Temple University)

• Dates: filed 1996-10-30; granted 1998-08-04. (Later expired for non-payment of maintenance fees.)
• Description: A generic solid-phase immunoassay platform. It is assay-format art only — no PSP/reg, no respiratory disease, no threshold, no treatment step.
• § 102 anticipation: None. It cannot anticipate any of claims 1–12, because it discloses none of the PSP/reg, VAP-diagnosis, ≥150/≥177 ng/ml, odds-ratio-13.8, or antibiotic-administration elements. Relevance is limited to § 103 as evidence that solid-phase/sandwich immunoassay formats were conventional (i.e., background for dependent claims 9–11).

2) US6309888B1 — "Detection and determination of the stages of coronary artery disease" (Leuven R&D VZW; inventors Holvoet & Collen)

• Dates: priority 1998-09-04; granted 2001-10-30.
• Description: Detects/stages coronary artery disease using markers such as oxidized/malondialdehyde-modified atherogenic proteins and a "heart protein," i.e., a multi-marker risk-stratification diagnostic.
• § 102 anticipation: None. Different disease, different analytes, no PSP/reg, no VAP, no treatment step. Its only marginal relevance is generic (biomarker cut-off/staging methodology → § 103 background).

3) US7358062B2 — "Method for diagnosing atrophic gastritis" (Biohit Oyj)

• Dates: priority 2001-01-05; PCT/FI02/00008 int'l filing 2002-01-04; granted 2008-04-15.
• Description: Diagnoses atrophic gastritis by measuring pepsinogen I, gastrin-17, and a Helicobacter pylori marker against cut-off/reference values (the GastroPanel concept). Generic "biomarker + cut-off → diagnosis" art.
• § 102 anticipation: None. No PSP/reg, no respiratory infection, no VAP, no antibiotic step. § 103 background only.

4) US20070224638A1 — "Secreted proteins as early markers and drug targets for autoimmunity, tumorigenesis and infections" (Institut Pasteur)

• Dates: filed 2006-03-27; published 2007-09-27. (Not independently re-verified this session.)
• Description: Per the title, a secreted-protein marker/discovery disclosure spanning autoimmunity, tumorigenesis, and infection. A "laundry-list of secreted proteins" type reference; PSP/reg (REG I) is a known secreted protein and could plausibly appear in such a list.
• § 102 anticipation: None as to claims 1 or 12. Even if it names PSP/reg, it does not disclose the VAP-specific diagnosis, the ≥150/≥177 ng/ml thresholds, the odds ratio of 13.8, or antibiotic administration — so no single-reference anticipation. Its best use is § 103 (PSP/reg as a known secreted protein marker) combined with the Zürich sepsis art.

5) WO2008021290A2 — "Organ-specific proteins and methods of their use" (Homestead Clinical Corporation)

• Dates: priority 2006-08-09; published 2008-02-21. (Not independently re-verified this session.) Note the co-cited non-patent reference LaBaer et al., J. Proteome Res. 2005, 4:1053–1059, consistent with Homestead Clinical being the LaBaer-affiliated protein-marker entity.
• Description: Organ-specific protein markers and their diagnostic/therapeutic uses — a likely source for pancreas-specific proteins (a category that includes PSP/reg).
• § 102 anticipation: None. Same defect as #4: it may establish PSP/reg as a known pancreas/organ-specific protein but discloses no VAP/threshold/treatment elements. § 103 background.

6) WO2008085601A2 — "Genemap of the human genes associated with asthma disease" (Genizon Biosciences Inc.)

• Dates: priority 2006-11-02; published 2008-07-17. (Not independently re-verified this session.)
• Description: Genetic-association map of asthma genes. Asthma is a lower-airway inflammatory condition (and the '390 specification does list asthma in its "airways and lungs" group), so this is the only cited reference touching the inflammatory-airway space from a genetic angle.
• § 102 anticipation: None. No PSP/reg protein measurement, no VAP, no thresholds, no treatment. § 103 background at most (and even then weak, being genetics rather than protein assay).

7 & 8) WO2009030456A1 and US20100222223A1 — "Method for assaying sepsis in humans" (Universität Zürich)

(These two are the same family: WO'456 = PCT/EP2008/007158; US20100222223A1 = its U.S. publication → granted US8435755B2, later continued as US9857381B2.)

• Dates: priority EP 07017539, 2007-09-07; PCT filed 2008-09-02; WO published 2009-03-12; US publication 2010-09-02.
• Description (verified): Discloses determining PSP/reg in a body fluid (serum) sample to predict/diagnose sepsis after severe trauma, with level thresholds of 60 ng/ml (days 3–5) / 80 ng/ml, and elaborates the sandwich ELISA (first antibody on microtiter plate → block → load sample → second, labeled anti-PSP/reg antibody → chromogenic substrate), antibody pairs from guinea pig/rat/mouse/rabbit/goat/chicken/donkey/horse, RIA/EIA/mass-spec/microarray options, and a kit. (CN101796418A claim set confirms this.)
• § 102 anticipation:
  • As to claims 1 and 12 — None. The reference is about post-trauma sepsis, not VAP; it does not diagnose VAP, and it recites 60/80 ng/ml, not ≥150 ng/ml (claim 1(b)), not ≥177 ng/ml at day 7 (claims 1(c)/12(c)), and no odds-ratio-13.8 limitation, and no antibiotic-treatment step. A single reference missing these limitations cannot anticipate.
  • As to the assay-format dependent claims (2, 3, 4, 8, 9, 10, 11) — highly relevant, but not anticipating as written, because each of those claims depends from claim 1 and therefore incorporates the VAP-diagnosis and treatment steps. If one imagined a standalone "detect PSP/reg by sandwich ELISA" claim, WO'456 would be a strong § 102 reference.
• Bottom line: This is the closest patent-family art on the detection methodology and the backbone of any § 103 challenge against claims 2, 4, 8, 9, 10, 11.

9) US20130165345A1 — "Method for assaying peritonitis in humans" (Universitaet Zuerich)

• Dates: priority 2010-08-31; published 2013-06-27. (Not independently re-verified this session.)
• Description: Sister Zurich application applying PSP/reg to peritonitis (abdominal infection).
• § 102 anticipation: None. Different infection site; no VAP; no thresholds/treatment at issue.
• ⚠ Priority / date flag: Its priority date (2010-08-31) is after the '390 patent's claimed priority date (2010-05-31). Assuming the '390 claims are entitled to the 2010-05-31 priority, this reference is not prior art at all (neither § 102(a)(1) — published later, nor § 102(a)(2) — effectively filed later). It appears on the face of the '390 patent mainly as related-art/citation context, not as anticipatory art.

3. Most relevant NON-PATENT prior art (from the "Non-Patent Citations (23)" list)

Ranked by relevance to claims 1 and 12:

★ 3.1 Boeck et al., "Pancreatic Stone Protein: a marker of organ failure and outcome in ventilator-associated pneumonia," Chest 2011;140(4):925–932 (Epub 2011-08-11)

• Why it matters most: This paper is essentially the published version of Example 1 of the '390 patent — the same 101-patient VAP cohort, the SOFA correlation, the AUC values (0.69 at onset; 0.76 at day 7), the cut-offs (24 ng/ml; 177 ng/ml at day 7) and the day-28 mortality prediction. It is therefore the only reference that speaks directly to the VAP + PSP/reg + outcome-prediction subject matter of claims 1/12.
• § 102 consideration — but with two critical caveats:
  1. Priority: Boeck et al. published August 2011, i.e., after the '390 patent's claimed 2010-05-31 priority date. If the '390 claims are entitled to that priority, Boeck et al. is not § 102 prior art. It would only become prior art if the claims are held not entitled to the 2010-05-31 priority (e.g., if the specific ≥150/≥177 ng/ml + odds-ratio-13.8 limitations were deemed unsupported by the 2010 disclosure and to rest on the 2018-03-05 filing).
  2. Inventor overlap / grace period: The paper's author list includes D. Stolz, a named '390 inventor. A disclosure by the inventor is excepted from prior art only if made ≤1 year before the effective filing date (§ 102(b)(1)(A)). Measured against the 2018-03-05 filing, Boeck (2011) is ~7 years earlier, outside the grace period. So if the '390 loses its 2010 priority, Boeck et al. becomes a serious § 102(a)(1)/§ 103 problem. This is the single most important validity-diligence question for this patent.
• Even if it qualified as prior art, does it anticipate claims 1/12 in full? Not necessarily — on the face of the '390 record, no cited art is shown to disclose the antibiotic-administration step (d) or the "odds ratio 13.8 … when day-7 PSP/reg ≥ 177 ng/ml" diagnostic limitation as such, so a complete § 102 anticipation is still not self-evident. It is better characterized as the primary § 103 reference.

Other NPL (background / § 103 support)

• Satomura et al., J. Gastroenterol 1995;30:643–650 — established a serum PSP/reg ELISA and normal serum values (~ng/ml range). Supports the "detecting PSP/reg" element and the ~10 ng/ml reference value, i.e., § 103 support against claim 2/8 methodology and the specification's reference values. Not anticipatory of claims 1/12.
• Keel et al., Crit Care Med 2009;37(5):1642–8 (cited in the '390 Background) — PSP/reg is increased and severity-related in trauma/sepsis. § 103 context for the "PSP/reg tracks inflammation severity" rationale. Not VAP-specific.
• Zhang Y.-W. et al., World J. Gastroenterol 2003;9(12):2635–41 — "Reg gene family and human diseases." Establishes REG/PSP/reg as a known marker family. § 103 background.
• Blasi F. et al., Pulmonary Pharmacology & Therapeutics 2010;23(6):501–507 — "Biomarkers in lower respiratory tract infections." Establishes the unmet need and the biomarker landscape (CRP, PCT, WBC) for lower RTIs. § 103 motivation/framing.
• Combes et al., Crit Care Med 2007;35(1):146–154 — early predictors of recurrence/death in VAP. Relevant prognosis context; not PSP/reg.
• Seligman et al., Critical Care 2008;12:R11 — copeptin as a VAP prognostic biomarker (comparator art).
• Harlow & Lane, Antibodies: A Laboratory Manual (1988) — general antibody-production / sandwich-ELISA methodology. § 103 support for dependent claims 9–11.
• (Also cited: Bimmler 1999; Bonten 1997; Carrere 1999; De Reggi 2001; Fujishiro 2012; Graf 2002; LaBaer 2005; Mayeux 2004; Micek 2007; Nakae 1999; Planas 2011 — all background/methodological, none anticipatory of claims 1/12.)

4. Bottom-line conclusions

1. No cited reference anticipates claims 1 or 12 in full. Every candidate is missing at least the VAP-specific diagnosis, the ≥150 ng/ml (claim 1(b)) / ≥177 ng/ml day-7 (claims 1(c)/12(c)) thresholds, the odds-ratio-13.8 limitation, and/or the antibiotic-administration step.

2. The most relevant prior art falls into three buckets:

   • Bucket A — same-subject-matter VAP art: Boeck et al., Chest 2011. Closest to claims 1/12 on the merits, but its prior-art status is priority-dependent (published after the 2010-05-31 priority; inventor-overlap). Treat as the key § 103 reference if priority is not sustained.
   • Bucket B — same-biomarker, different-disease Zurich family (WO2009030456A1 / US20100222223A1 / US8435755B2): the closest methodology art (serum PSP/reg, sandwich ELISA, antibody pairs, cut-offs, kit). Strongest § 103 art against the detection-format dependent claims (2, 4, 8, 9, 10, 11), and useful for showing PSP/reg serum cut-offs were known.
   • Bucket C — generic immunoassay / biomarker-with-cut-off art (US5789261A, US6309888B1, US7358062B2, Harlow & Lane): § 103 background only.

3. Two references deserve a specific date-related caution:

   • US20130165345A1 (priority 2010-08-31) is later-priority than the '390 priority and therefore not § 102 art if the '390 priority holds.
   • Boeck et al. (Chest 2011) is the single greatest validity question: it would be prior art only if the '390 claims lose the 2010-05-31 priority, and it duplicates the patent's own Example 1.

5. Explicit uncertainties

• Unverified in-session: the full text/claims of US20070224638A1, WO2008021290A2, WO2008085601A2, US20130165345A1, and most of the non-patent literature beyond the Boeck/Zurich items — my targeted searches were terminated by the tool-step limit. The citation data for these come from the patent's own "Cited By / Citations" listing, which I treat as authoritative for existence and dates but have not independently confirmed for disclosure content. In particular, my statement that US20070224638A1 / WO2008021290A2 "may list PSP/reg" is an inference from their titles, not a verified disclosure, and should be checked against the actual documents before being relied on for a § 102/§ 103 position.
• Assay of anticipation is legal, not mine to conclude. My "no anticipation" finding is based on the elements recited in claims 1/12 against the disclosure summaries available; it is not a freedom-to-operate or invalidity opinion.
• USPTO-native confirmation pending. I did not retrieve a USPTO Patent Center / file-wrapper copy showing the examiner's exact § 102/§ 103 rejections or the IDS submission dates; those would confirm which of these references the examiner actually relied on versus which were merely cited by the applicant. For a definitive prior-art analysis, pull the Patent Center "References Cited" and the examiner's non-final/final office actions for application 15/911,347.

I'll ground the analysis by verifying what the key listed prior-art references actually teach.

Strong material. Let me verify a few more anchors: the published PCT disclosure, the Blasi review, and the ATS guideline treatment step.

Obviousness Analysis — US 11,402,390 B2 under 35 U.S.C. § 103

Subject: "Method for detecting pancreatic stone protein/regenerating protein (PSP/reg) and treating VAP," claims 1–12 (claims 1 and 12 independent; 2–11 depend from claim 1).

Bottom line up front: Claims 1–12 are, in my assessment, highly vulnerable to a § 103 challenge, and the vulnerability is unusual in its severity because the most damaging art is already on the face of the patent and, in several places, is reproduced nearly verbatim in the '390 specification itself. The single most important variable is a priority question (Section 2). If the claims are entitled to the 2010-05-31 priority date, the attack runs through the Universität Zürich sepsis family as primary art. If priority is lost for any claim, the inventors' own Boeck et al., Chest 2011 reference becomes § 102/§ 103 art and the case becomes close to dispositive.

1. Governing statute and framework

• Application 15/911,347 filed 2018-03-05; claimed priority chain 2010-05-31 (provisional) → PCT/IB2011/052381 → US 13/701,433 (abandoned) → 15/911,347. Because the priority chain reaches back before 2013-03-16, pre-AIA § 102/§ 103(a) applies unless a claim at any time had an effective filing date on or after 2013-03-16, in which case AIA § 102/§ 103 governs. For the references discussed below the outcome is materially identical under either regime; I flag the one place where it matters.
• Governing obviousness framework: Graham v. John Deere, 383 U.S. 1 (1966) (scope/content/level of skill → differences → secondary considerations), as applied in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (predictable combination of known elements; finite number of identified, predictable solutions; design incentives; "obvious to try").
• Because there is no litigation record (see the earlier litigation sections), no claim construction under Phillips exists. For an IPR/PGR the Board would apply the Phillips standard for post-grant proceedings; for ex parte prosecution, BRI. The constructions that matter are addressed in Section 4.

2. Threshold issue — priority/effective filing date (the crux)

Why this matters. The '390 claim 1 element (c) — "when the quantity of PSP/reg present in said sample on day 7 after the VAP onset is a quantity equal or higher than 177 ng/ml" — and the Example 1 statistics (AUC 0.69/0.76; SOFA ρ = 0.49; 24 ng/mL at onset; 177 ng/mL at day 7; n = 101; n = 20 non-survivors) are exactly the content of Boeck et al. 2011, whose author list includes Stolz (a named '390 inventor), Graf, and Eggimann. See PubMed 21835904 and the author-hosted full text at abionic.com; the abstract states verbatim: "PSP/reg levels at VAP onset were elevated in nonsurvivors … The areas under the receiver operating characteristic curves of PSP/reg to predict mortality/survival were 0.69 at VAP onset and 0.76 at day 7. … levels above 177 ng/mL at day 7 were present in patients with a very poor outcome."

Two facts cut in the patentee's favor on priority and one cuts hard against:

• In favor: the 177 ng/mL day-7 figure and Fig. 3 ROC description are present in the published PCT (WO 2011/151783 A1), which was filed 2011-05-31 — so the specification's Example 1 disclosure pre-dates the Boeck print publication by ~2½ months. (Verified: WO2011151783A1 Fig. 3 text states "177 ng/ml at day 7 was the best threshold to predict death with a sensitivity of 54% and a specificity of 90% (AUC: 0.76)".)
• Against: the claims recite, as an affirmative limitation, "an odd ratio … of 13.8 with a 95% confidence interval." I have not verified that this specific odds ratio (and its 3.3–57.1 CI) appears in the 2011 priority PCT. If it was added by amendment in the 2018 continuation or in the 2020/2021 prosecution responses, that claim's § 112(a) written-description support runs only to the 2018 filing date, the priority claim fails for that claim, and Boeck (2011) becomes § 102(a)(1)/§ 103 art with no grace period. This is the single highest-value diligence item for any challenger: pull the 15/911,347 file history and compare the as-filed claims/spec against WO 2011/151783.

Flagged contradiction with the earlier-generated section. The prior summary states Boeck et al. is "the closest published work to the VAP subject matter claimed here." That is right as a matter of subject matter, but potentially misleading as a matter of prior-art status: Boeck was published 2011-08-11, i.e., after the 2010-05-31 priority date. The closest qualifying art on the 2010 date is the Universität Zürich sepsis family, not Boeck. Boeck's status is entirely derivative of the priority question above.

3. Level of ordinary skill in the art (POSITA)

The claimed subject matter sits at the intersection of critical-care medicine and clinical immunoassay development. A reasonable formulation (aligned with how the examiner appears to have treated it — the cited art spans both diagnostics and clinical VAP studies):

A POSITA is a person with an M.D. or Ph.D. in medicine, biology, biochemistry or a related field and at least 2 years of experience in clinical biomarker research and immunoassay development, or a person with a bachelor's degree in a relevant field and 4–6 years of practical experience in immunoassay development and clinical validation — in either case with access to, or collaboration with, a clinician skilled in managing ventilated ICU patients.

Two consequences:

1. The POSITA is not a hypothetical: the actual prior-art authors (Graf, Bimmler, Keel of Zürich; Stolz of Basel; Boeck, Eggimann, Tamm) are the same small community, and the '390 specification's own Background cites Keel et al., Crit Care Med 2009;37(5):1642-8 — i.e., the Zürich group's own sepsis work. Actual, documented motivation to combine, not hypothetical.
2. The POSITA is skilled at the routine ROC/threshold-optimization work that generated the 24 ng/mL and 177 ng/mL cut-offs.

4. Claim-construction points that materially expand the prior-art hit rate

These are adverse to the patentee and should be pressed:

(a) "optionally" in steps (a) and (b) of claims 1 and 12. The claim recites obtaining the sample "optionally on a day of VAP onset and/or on day 2, 3, 4, 5, 6 … and on day 7." Read literally (and the operating rule here — and the earlier section — is do not auto-correct), the sampling/detection schedule in steps (a) and (b) is permissive. A method that simply obtains a serum sample and measures PSP/reg satisfies (a) and (b) on their face. The only mandatory timing limitation is in step (c): the day-7 determination. Even under the narrower reading (that "optionally" attaches only to days 0 and 2–6, with day 7 required), the practical scope is the same: sample, measure, and act on a day-7 PSP/reg value.

(b) The 150 vs. 177 ng/mL mismatch. Step (b) requires screening at ≥150 ng/mL; step (c) requires diagnosing at ≥177 ng/mL on day 7. Because ≥177 satisfies ≥150, the two limitations collapse: the operative numeric threshold of claim 1 is 177 ng/mL at day 7. The 150 ng/mL figure is thus largely redundant, and it is itself drawn straight from the '390's own description ("a PSP/reg level higher than or equal to 150 ng/ml, preferably higher than 180 ng/ml … is associated with a high risk of mortality").

(c) "diagnosing … with an odd ratio … of 13.8 with a 95% confidence interval." This is a statistical descriptor of a population outcome, not a physical step or a technical feature. Expect a challenger to argue (i) it is non-functional descriptive material entitled to no patentable weight in the § 103 analysis (In re Gulack; In re Ngai), (ii) it is indefinite under § 112(b) because the claim does not state the endpoints of the confidence interval (the specification supplies 3.3–57.1 only in Example 1), and (iii) it is a result — the outcome of the very study the inventors ran — and a claim cannot be rendered non-obvious merely by reciting the numerical result of applying known methods to a known population. In re Kao and Honeywell v. ITC both counsel that results/outcomes recited without a corresponding technical limitation get little or no weight.

(d) Preamble "A method for detecting PSP/reg and treating VAP." Where the body of the claim sets out the complete method, the preamble is generally not limiting; "detecting PSP/reg" is an intended use.

Net effect: stripped to its effective scope, claim 1 is:

(1) obtain a body-fluid sample; (2) measure PSP/reg; (3) if the day-7 post-VAP-onset value is ≥177 ng/mL, conclude VAP with a poor prognosis; (4) give an antibiotic.

Claim 12 differs only by dropping the redundant 150 ng/mL screen. Every one of those four elements was known or obvious by 2010 (or, at the latest, was squarely disclosed by Boeck 2011).

5. The prior-art landscape, grouped by function

I rely on the "Citations (9)" / "Patent Citations (9)" and "Non-Patent Citations (23)" lists reproduced on the face of the patent, plus the earlier sections' bibliographic work. Where I have not read the full text I rely on title/abstract and flag it.

5.1 Primary reference — the Universität Zürich PSP/reg sepsis family

WO 2009/030456 A1 (pub. 2009-03-12); US 2010/0222223 A1 (pub. 2010-09-02); US 8,435,755 B2 (issued 2013-05-07); EP 2 185 937 B2. Inventors Graf, Bimmler, Keel. Verified substantively.

This reference is extraordinarily close. Its claim 1 is: "A method of prediction of sepsis after trauma in a human comprising: (a) quantifying a level of pancreatic stone protein/regenerating protein (PSP/reg) in a serum sample of said human obtained on days 3, 4 or 5 after said trauma, (b) determining whether the level of PSP/reg quantified in said serum sample is above 60 ng/ml, and (c) predicting that the human will develop posttraumatic sepsis when the level … is above 60 ng/ml."

What else it teaches, verbatim or nearly so, and how badly it maps onto the '390:

Critically: the '390 specification's ELISA, antibody-pair, label, kit, and "other body fluids" passages are copied essentially verbatim from this reference. A patentee cannot argue that these techniques were non-obvious when its own specification recites them as the state of the art. Sources: https://patents.google.com/patent/WO2009030456A1/en ; https://patents.justia.com/patent/[8435755](/patent/8435755) (claims); https://patents.google.com/patent/CN101796418A/en (claims 1–8).

The only meaningful difference is the disease label: Zürich claims post-traumatic sepsis; the '390 claims VAP. That difference is bridged by 5.2–5.5 below (and, decisively, by combination with Satomura and the VAP-specific references).

5.2 VAP-specific clinical references (bridge the indication gap)

5.3 PSP/reg assay references

• Satomura et al., J Gastroenterol 1995;30:643-650 — "Measurement of serum PSP/reg-protein concentration in various diseases with a newly developed enzyme-linked immunosorbent assay." Supplies the PSP/reg ELISA per se, plus the knowledge that PSP/reg serum levels rise in disease. The '390 Background cites this.
• US 5,789,261 A (Temple University) — "Solid phase immunoassay." Generic but supportive for the sandwich-format claims 9–10. (Not read in full.)
• US 7,358,062 B2 (Biohit Oyj) — "Method for diagnosing atrophic gastritis." Threshold-based immunoassay diagnosis from a serum biomarker. (Not read in full.)
• Harlow & Lane, Antibodies: A Laboratory Manual (1988), pp. 553, 556, 578-581 — standard antibody production/conjugation; supplies claim 11's obviousness.
• Bimmler 1999; Graf 2002; De Reggi 2001; Nakae 1999; Zhang 2003; Carrere 1999; LaBaer 2005; Mayeux 2004. PSP/reg biology, molecular forms, and biomarker-validation methodology. Carrere 1999 (Gut 44(4)) is notable as it links immunoreactive Reg protein to a respiratory disease (cystic fibrosis) — a bridge from pancreas-derived protein to lung pathology.

5.4 Platform / disease-staging references

• US 6,309,888 B1 (Leuven R&D) — "Detection and determination of the stages of coronary artery disease." Teaching that a protein biomarker assay can stage/stratify severity of disease. (Not read in full.)
• WO 2008/021290 A2 (Homestead Clinical) — "Organ-specific proteins and methods of their use." Teaching the use of organ-derived proteins as diagnostic markers. (Not read in full.)
• US 2007/0224638 A1 (Institut Pasteur) — "Secreted proteins as early markers and drug targets for autoimmunity, tumorigenesis and infections." Teaching that secreted proteins serve as early infection markers. (Not read in full.)
• WO 2008/085601 A2 (Genizon Biosciences) — "Genemap of the human genes associated with asthma disease," with Geneseq sequence ASQ27792 ("Human asthma disease treatment associated protein"); the '390 prosecution also cites Geneseq AUN17559 ("Human pancreas-specific protein"). These tie the REG/PSP gene family to airway disease.
• US 2013/0165345 A1 (Zürich, peritonitis) — not prior art to the '390 (priority 2010-08-31 > 2010-05-31). The earlier-generated sections list it among "key prior art cited on the face of the patent"; it is cited, but it does not qualify as prior art on the 2010 date, and I flag that as a refinement.

5.5 The Boeck 2011 reference (conditional)

Boeck, Graf, Eggimann, Pargger, Raptis, Smyrnios, Thakkar, Siegemund, Rakic, Tamm, Stolz, Chest 2011;140(4):925-932, Epub 2011-08-11; ISRCTN61015974. Teaches, in terms:

• 101 clinically diagnosed VAP patients; serum PSP/reg from VAP onset up to day 7;
• primary endpoint death within 28 days of VAP onset;
• SOFA correlation ρ = 0.49 (P < .001) from onset through day 7;
• AUC 0.69 (onset) and 0.76 (day 7) for mortality/survival;
• "PSP/reg levels below 24 ng/mL at VAP onset were associated with a good chance of survival"; "levels above 177 ng/mL at day 7 were present in patients with a very poor outcome."

That is '390 claim 1(c) and claim 12(c) — day 7, 177 ng/mL, mortality — plus the Fig. 3A/3B ROC material, in a single printed publication. Boeck is the '390's own Example 1. URL: https://pubmed.ncbi.nlm.nih.gov/21835904/ ; hosted full text: https://abionic.com/sites/default/files/2025-04/Boeck_Chest_2011.pdf

6. Combination 1 (primary): Zürich + VAP-prognosis references + Satomura + ATS guidelines

References: WO 2009/030456 A1 / US 2010/0222223 A1 / US 8,435,755 (primary), in view of Seligman 2008, Combes 2007, Bonten 1997, Blasi/Stolz 2010, Satomura 1995, and the ATS 2005 guidelines (with Micek 2007).

6.1 Claim 1 — element-by-element

6.2 Claims 2–11

Claims 8–11 are, in substance, section 102-level disclosures in a reference the '390 itself cites. They cannot survive § 103 on any theory that does not also require claim 1 to survive, and claim 1's only distinguishing feature is the VAP/day-7/177 ng/mL axis addressed above.

6.3 Claim 12

Identical analysis minus the redundant 150 ng/mL screen. Claim 12 is, if anything, broader and weaker — it recites only "determining whether PSP/reg is present," with the entire inventive weight resting on the day-7/177 ng/mL/13.8 recitation.

7. Combination 2 (conditional but decisive): Boeck 2011 as primary reference

If any claim is not entitled to the 2010-05-31 priority date, then:

• § 102(a)(1)/§ 103: Boeck 2011 is a printed publication more than one year before 2018-03-05; the § 102(b)(1)(A) inventor grace period does not reach back to 2011. Boeck expressly discloses the day-7/177 ng/mL/28-day-mortality correlation and the day-0/24 ng/mL survival correlation. Claim 12 is arguably anticipated but for step (d); claim 1 likewise but for step (d).
• Step (d) is then supplied by: the ATS 2005 guidelines (routine empiric antibiotics for VAP), Zürich ("costly antibiotic treatment"), and Micek 2007. Boeck + ATS Guidelines → claims 1 and 12 obvious; add Zürich and Satomura for claims 2–11. The "odd ratio of 13.8" adds nothing (Section 4(c)) and, if anything, evidences that the OR was simply the arithmetic result of the Boeck data set.

Note also that the '390's own Example 1 reports 20 non-survivors and the abstract's Fig. 2 caption reports "non-survivors (NS; n=19)," while Boeck reports n = 20 non-survivors and the '390 Table 1 reports n = 20 — an internal inconsistency in the '390 that further suggests the Example was assembled from the Boeck data set.

8. Why a POSITA would have combined these references (the KSR rationales)

1. Same field, same problem, same team. Zürich (Graf/Bimmler/Keel) and Basel (Stolz) were the two groups doing exactly this work; the '390 Background cites Keel 2009 — the Zürich group's own sepsis paper — as the foundational teaching that "PSP/reg level is related to the severity of inflammation" and is "highly increased in patients during sepsis." The applicant thus admitted the field and the starting point. Under KSR, "the background knowledge possessed by a person having ordinary skill in the art" includes what the specification concedes.
2. VAP is a sepsis syndrome of the lung. The '390 specification states in terms: "VAP is a potentially serious medical condition than can lead to sepsis through the development of a systemic infection." A marker validated for systemic infection/sepsis is therefore an obvious candidate for the pulmonary precursor condition. KSR: "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious."
3. The objective was known and articulated. Blasi/Stolz 2010 (co-authored by the inventor) framed the goal as using biomarkers to "improve the diagnosis, risk-stratification and management of lower respiratory tract infections." Seligman 2008 demonstrated that a novel serum biomarker can prognosticate VAP outcome. Combes 2007 and Bonten 1997 addressed VAP prediction and death. The '390's own Background states the problem: "Detecting the presence, defining the cause, and predicting the severity of lower respiratory tract infections are constant challenges."
4. Predictable results, finite solutions. The claim requires measuring a known analyte with a known assay (Zürich/Satomura) in a known patient population (VAP) at a time point or two (Zürich already taught days 3/4/5), and applying a threshold generated by routine ROC analysis (Zürich taught exactly this, with a table of cut-offs and sens/spec/PPV/NPV). KSR: combination of known elements "according to known methods … to yield predictable results," and "a finite number of identified, predictable solutions."
5. The treatment step is the standard of care. Claim 1(d) — "administering an effective amount of an antibiotic" — is what every physician does upon diagnosing VAP (ATS 2005 guidelines, cited by the '390 itself). Reciting the conventional clinical response to a diagnosis does not confer patentability; it is precisely the kind of "apply it" instruction that Mayo step 2B and KSR treat as insignificant activity.
6. No teaching away. Satomura 1995 and Zürich both note that PSP/reg rises in "various diseases," which the patentee may argue cuts against disease specificity — but under KSR a general teaching does not teach away from a specific application; the correct reading is that PSP/reg is a general inflammation/severity marker, which is exactly the property that makes it a candidate for VAP. Nothing in the cited art criticizes the use of PSP/reg in VAP.

9. What the patentee will argue, and the likely rebuttal

10. Recommended challenge posture (if this were an IPR or a validity opinion)

1. First, resolve the priority question. Obtain the 15/911,347 file history; compare the as-filed claims and specification against WO 2011/151783 and against the '390's ultimate claims (particularly the "13.8 with a 95% confidence interval" language). If the OR limitation is new matter, the entire case collapses toward § 102 on Boeck.
2. Ground 1 (primary): Claims 1–12 obvious over WO 2009/030456 A1 in view of Seligman 2008, Combes 2007, Bonten 1997, Blasi/Stolz 2010, Satomura 1995, and the ATS 2005 Guidelines.
3. Ground 2: Claims 1–12 obvious over US 8,435,755 B2 (same family, claim-per-claim for claims 8–11) in the same combinations.
4. Ground 3 (conditional on priority loss): Claims 1 and 12 anticipated/obvious over Boeck 2011; claims 2–11 obvious over Boeck in view of Zürich, Satomura, and Harlow & Lane.
5. Secondary grounds: § 112(b) for "odd ratio … with a 95% confidence interval"; § 112(a) if the priority/inventorship analysis fails; and note the internal 54%/90% (Fig. 3 caption) vs. 58%/91% (Example 1) discrepancy — a § 112(b) and evidentiary-credibility issue.

11. Residual uncertainties and explicit caveats

1. I have not examined the 15/911,347 file history. The priority/new-matter question in Section 2 is the pivot of the whole analysis and cannot be resolved from the patent text alone. This must be checked.
2. I have read only the abstract/title for US 5,789,261 A, US 6,309,888 B1, US 7,358,062 B2, US 2007/0224638 A1, WO 2008/021290 A2, and WO 2008/085601 A2. They are characterized above from their titles and the roles assigned to them in the '390's citation list; do not treat those characterizations as verified disclosures without pulling the documents.
3. I verified WO 2009/030456 A1 / US 8,435,755 / EP 2 185 937 B2 substantively (claims 1–7 and the ELISA/antibody/passage text) and verified Boeck 2011's abstract and Fig. 4 caption (PubMed 21835904; abionic.com-hosted PDF). The near-verbatim overlap between the '390 specification and the Zürich specification is the single most probative fact in this analysis and should be quoted side-by-side in any petition.
4. Blasi/Stolz 2010 qualifies as art on the 2010-05-31 date because its Epub was 2010-04-29, notwithstanding the December 2010 issue date. I flag this because the earlier-generated sections listed Blasi without a date analysis.
5. Consistency note: This analysis adopts the earlier sections' verbatim readings of the claim text (the "optionally" qualifiers, "odd ratio," and the 150-vs-177 divergence) and does not auto-correct them. Section 6 of the earlier material stated that Boeck 2011 is the "closest published work" — as noted in Section 2 above, that is accurate as to subject matter but requires the priority caveat as to prior-art status.

Overall assessment. On the ordinary Graham/KSR analysis, and setting Boeck aside, I would rate claims 1–12 as likely obvious over the Zürich sepsis family combined with the VAP-specific clinical literature, the ATS treatment standard, and Satomura's PSP/reg ELISA — with claims 8–11 being essentially foreclosed. If the "177 ng/mL at day 7" / "odds ratio 13.8" limitations cannot be traced to the 2010-05-31 priority disclosure, the analysis becomes close to anticipatory on Boeck 2011, and the odds ratio limitation, being a statistical outcome of the inventors' own study rather than a technical step, should be afforded little or no patentable weight.