US 11402393

I'll search for this specific patent number. Let me run several targeted queries.

Let me check for litigation and CAFC dockets, plus the related EP appeal.

Let me do a few more targeted searches on litigation and any CAFC activity.

US 11,402,393 B2 — Analyst Summary

Source note: I could retrieve the patent's own full text and bibliographic record (Google Patents mirror of USPTO data, plus the Justia mirror of the official claims). I could not identify any Federal Circuit 2026 docket, or any US district court case, naming this specific patent. I flag that as an absence of evidence, not proof of absence.

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Bibliographic data (as recorded)

Prosecution history note: This is a continuation that issued after the parent US 13/583,350 (US 2013/0096052 A1) went abandoned. Claims were repeatedly rejected/amended (non-final actions 2019, 2020, 2021; a final rejection 2021-04-26, reopened via RCE; allowance 2022-03-29). Family members include EP 2545379 B1 (recorded as revoked), JP 5798133 B2, CN 102822675 B, RU 2580278 C2, ES 2557891 T3, BR 112012022509 A2, ZA 201206681 B.

Abstract (verbatim)

"The present invention relates to the determination of the level of marker peptides in a sample derived from a bodily fluid of a subject presenting with non-specific complaints."

Independent claim — plain-language overview

There is one independent claim (claim 1); claims 2–6 all depend from it. It is drafted as a method of diagnosis and treatment (a "diagnose-and-treat" claim), comprising four practical steps plus two patient-eligibility limitations:

1. Assay step. Detect and quantify PCT (or a PCT fragment of ≥12 amino acids) in a bodily-fluid sample, using a PCT detection assay whose functional assay sensitivity is below 0.06 ng/mL, by contacting the PCT analyte with a capture molecule that specifically binds it to form a detectable complex, and detecting that complex.
2. Patient population — inclusion. The patient (a) does not have a primary disease other than an infection, and (b) is admitted to an emergency department and is judged by a physician to display one or more non-specific complaints drawn from a closed list: not feeling well, feeling weak, feeling exhausted, being tired or sleepy, feeling dizzy, being unable to cope with usual daily activities, or being unable to recall why they were sent to the ED.
3. Patient population — exclusion (proviso). The patient displays no symptom or condition specific to bacterial infection from a closed list, including headaches; pain in a specific body part; fever >38 °C; localized redness; swelling; nausea with vomiting; local pain; systolic BP <90 mm Hg; heart rate >120/min; body temperature <35.6 °C; respiratory rate >30/min; shaking and chills; respiratory symptoms (cough, excess sputum, dyspnea, tachypnea, pleuritic pain); abnormal auscultation finding; and symptoms of infection of a listed organ/organ system (respiratory tract, digestive tract, vaginal, meningitis, sepsis, erysipelas, peritonitis, cholangitis, cholecystitis, osteomyelitis).
4. Threshold step. A PCT level above a predetermined threshold of 0.02 ng/mL indicates a bacterial infection.
5. Treatment step. Administering an antibiotic to the patient upon that determination.

Dependent claims:

• Claim 2: threshold is 0.06 ng/mL.
• Claim 3: threshold is 0.05 ng/mL.
• Claim 4: threshold is 0.1 ng/mL.
• Claim 5: sample is blood, serum, plasma, cerebrospinal fluid, urine, saliva or pleural effusion.
• Claim 6: the infection to be diagnosed/treated is selected from a list: lower respiratory tract infection, infection, urinary tract infection, vaginal infection, sepsis, severe sepsis, septic shock, digestive tract infection, peritonitis, cystitis, colitis, bacterial meningitis, sinusitis, pharyngitis, cholangitis, cholecystitis, osteomyelitis, erysipelas — with "peritonitis, cholangitis, cholecystitis" repeated and "osteomylitis" misspelled in the granted text (reproduced literally; these appear to be drafting artifacts, not deliberate terms).

Supporting clinical data in the specification

A 415-patient ED cohort; 86 diagnosed with bacterial infection (pneumonia, cystitis, UTI, sepsis, urosepsis, septic shock, bronchitis, etc.). PCT on admission was significantly higher in infected vs. non-infected patients (p <0.0001); ROC AUC = 0.721. PCT measured with an ultrasensitive assay (functional assay sensitivity 0.007 ng/mL) as described in Morgenthaler et al. 2002. Independent claim 1's "below 0.06 ng/mL" assay-sensitivity limitation is broader than the 0.007 ng/mL example.

Litigation / docket findings

• Google Patents shows a "First worldwide family litigation filed" flag linked to a Darts-ip family record (family ID 42270075), which indicates litigation exists somewhere in this patent family — it does not tell us which member, court, or year.
• No Federal Circuit 2026 docket, and no US district court complaint, naming US 11,402,393 was found in my searches. Treat this as not found, not as confirmation that none exists — CAFC and PACER dockets are not fully indexed by general web search.
• On the European side, the counterpart EP 2545379 B1 is recorded as revoked, and an EPO Board of Appeal decision addressing this case's claims (NSC patient definitions, threshold range 0.02–0.25 ng/mL, "no working diagnosis with sufficient certainty," ESI 2–3) surfaced. The document URL reads .../t181297eu1.pdf; I am not confident how to parse that case number (e.g., T 1812/19 vs. T 1812/97), so I deliberately do not assert a specific appeal number.
• Note: some search hits about USPTO IPR petitions concerning "advanced detection of sepsis" (claims citing U.S. Pat. No. 8,669,113 and procalcitonin/lysophosphatidylcholine) are different patents and should not be attributed to US 11,402,393.

Caveats

• Bibliographic dates above are from the mirror of official records; the "adjusted expiration 2032-08-07" is reproduced literally (it implies term adjustment and does not simply equal 20 years from the 2010-03-08 priority or the 2011-03-08 PCT filing).
• The claim list in the pre-grant publication US 2017/0370949 A1 differs from the granted claims (the published version had an independent claim 14); the granted claim set is the six claims summarized above.

I'll search for litigation involving US patent 11402393 across patent litigation databases.

The initial results returned a different patent (US12213933 — massage guns). Let me search more specifically for the exact patent and check litigation databases.

Let me check litigation-specific databases and the Darts-ip family link referenced in the patent.

Summary of search results

Bottom line: I found no US litigation — no district court case, ITC action, or CAFC appeal — involving U.S. Patent No. 11,402,393.

A note on the specific identifier, per your instruction to interpret IDs literally: several searches superficially "matched" the digits but were for a different patent. In particular, initial results returned cases about U.S. Patent No. 12,213,933 (Hyperice IP Subco, LLC — massage-gun percussive therapy), consolidated in W.D. Wash. lead case Toloco Inc. v. Hyperice IP Subco, LLC, No. 2:25-cv-01560-KKE. That is US 12,213,933, not US 11,402,393, and it has nothing to do with the BRAHMS procalcitonin patent. I have excluded it.

What US 11,402,393 actually is

• Patent: US 11,402,393 B2, "Procalcitonin for the diagnosis of bacterial infections and guidance of antibiotic treatment in patients with non-specific complaints."
• App. No. 15/700,531; filed 2017-09-11; granted 2022-08-02; priority 2010-03-08 (EP10002363).
• Assignee: B.R.A.H.M.S GmbH (Thermo Fisher group). Inventors: Struck, Nickel, Bingisser, Giersdorf, Hartmann.
• Continuation of abandoned US 13/583,350 (pub. US20130096052A1); national-phase entry of PCT/EP2011/053476 (WO2011110565A1; EP counterpart EP2545379B1).
• Google Patents family page shows a generic "First worldwide family litigation filed" flag with a Darts-ip pointer to family 42270075 (link: https://patents.darts-ip.com/?family=42270075). This is a database indicator tied to the family, not a verified US case, and the underlying Darts-ip record is behind a paywall. I could not verify any US case from it. I flag it as an unverified lead rather than a confirmed case.

Proceedings that exist for this patent family (foreign — NOT US litigation)

The closest thing to litigation/enforcement activity I can confirm is at the EPO, not in US courts:

• T 1297/18 ("Patients with non-specific complaints / BRAHMS"), EPO Board of Appeal, decision 07.04.2021 — appeal in the opposition against the EP member of this same family (EP 2 545 379). This confirms at least one EPO opposition was filed against the European counterpart. It is an administrative opposition/appeal, not infringement litigation, and it does not involve US 11,402,393.
• T 0580/19 ("Procalcitonin for diagnosis of infections / B.R.A.H.M.S."), opponent Radiometer Medical ApS — relates to a different BRAHMS PCT patent (acute stroke/TIA), not this one.

Broader BRAHMS PCT litigation (different patents — do not attribute to 11,402,393)

For completeness and to show due diligence, the BRAHMS/Thermo Fisher PCT patent wars surface extensively, but none of the following involves US 11,402,393:

Conclusion / honest limitation

Based on the databases and sources reachable in this search, there is no known litigation — US or otherwise — specifically naming U.S. Patent No. 11,402,393. The only litigation-related signals I can point to are (a) the Google Patents/Darts-ip family-level "litigation filed" flag for family 42270075, which I could not verify, and (b) the EPO opposition/appeal T 1297/18 against the EP family member (an administrative proceeding, not litigation). The confirmed courtroom disputes involving BRAHMS PCT patents concern other patent numbers (EP 0 880 702, EP 2 028 493, EP 2 301 626, EP 2 084 545, EP 2 293 078, ZL93118343.X, and a Japanese PCT patent), and should not be recorded against US 11,402,393.

If you need certainty, the authoritative next steps would be: (1) a PACER/RECAP docket search on the patent number and on "B.R.A.H.M.S"; (2) the Unified Patents litigation portal (https://portal.unifiedpatents.com/litigation/caselist); and (3) pulling the Darts-ip family 42270075 record, which is the source of the "first worldwide family litigation" flag. I was unable to complete those specific lookups before reaching my search limit, so I cannot yet rule out an unindexed or recently filed action.

PTAB Proceedings Report — US 11,402,393 B2

Patent: Procalcitonin for the diagnosis of bacterial infections and guidance of antibiotic treatment in patients with non-specific complaints
Patent owner / current assignee of record: B.R.A.H.M.S. GmbH (Hennigsdorf, DE) — a Thermo Fisher / Siemens Healthineers-affiliated diagnostics portfolio
Priority: 2010-03-08 · Continuation filed: 2017-09-11 · Granted: 2022-08-02 · Adjusted expiration: 2032-08-07
Claims on file: 6 (1 independent; 2–6 dependent)

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Proceedings overview

There are zero AIA trial proceedings on US 11,402,393. Per the structured "PTAB proceedings on file" block from the USPTO Open Data Portal (no AIA trial proceedings as of the most recent ingest), and confirmed by my own web checks on 2026-09-29 against PTAB-related sources and docket aggregators, the breakdown is: 0 active, 0 claims invalidated, 0 claims sustained, 0 settled, 0 institution denied. The one caveat worth flagging is the standard one — ODP ingest lags real-time filings, and a recently filed petition (particularly one filed in the last few months) may not yet be indexed; but nothing in public search results contradicts the "no activity" default, so I treat it as reliable.

Bottom line for a defendant: there is no IPR-based shortcut and no invalidation estoppel scaffold to inherit. The patent is untested at the PTAB, not hardened — all six claims carry their original scope, and the full prior-art runway under §§ 102/103/112 is still open to you, subject only to whatever the district court record shows if the patent has been asserted. Do not read the absence of IPRs as a signal of strength; read it as a signal that either the asserted universe is small, or that challengers have chosen district court and ex-US fora instead (see below).

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Proceedings on US 11,402,393

None — no AIA trial proceeding has been filed against this patent

• Type: N/A
• Filed: N/A
• Status: No petition on file (USPTO ODP ingest: no AIA trial proceedings; web checks 2026-09-29 concordant)
• Judge panel: N/A
• Petition grounds: N/A
• Institution decision: N/A — no petition to decide
• Final Written Decision: N/A — no claim of US 11,402,393 has ever been construed or adjudicated by the Board
• Settlement / termination: N/A
• Appeal: N/A — no FWD exists to appeal; I found no Federal Circuit docket, CourtListener entry, or CAFC opinion referencing US 11,402,393
• Defensive value: You cannot lean on any PTAB cancellation, and you cannot inherit anyone's § 315(e)(2) estoppel. Any validity challenge you want to make on § 102/§ 103 grounds is yours to build from scratch, with no estoppel shadow and no Board claim construction to argue from.

Sanity check on my sources: I searched for the patent number paired with IPR/PGR terms, for B.R.A.H.M.S./BRAHMS procalcitonin PTAB challenges, and for Radiometer-filed petitions against BRAHMS patents. The only PTAB hits that emerged involve a different patent (US 9,091,698 — PGR2016-00018, B.R.A.H.M.S. GmbH v. Becton, Dickinson & Co.), which I address below as context only. I did not find any proceeding number I can honestly attribute to US 11,402,393, and per your instructions I am not inventing one.

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Related proceedings that are NOT on this patent (context only — do not cite these as PTAB activity on the '393 patent)

These matter strategically because they show you how this patent family has actually been attacked — and it has been attacked hard, just not here.

1. PGR2016-00018 — B.R.A.H.M.S. GmbH v. Becton, Dickinson & Co. (PGR on US 9,091,698, "Advanced Detection of Sepsis"). Instituted 2016 on §§ 112(a)/(b) written description, enablement and indefiniteness plus § 102/§ 103 art, after the Board found the claims were not entitled to pre-AIA priority and were therefore PGR-eligible. This is the same patent-owner family and the same procalcitonin diagnostic space, but a different patent with different claims. Institution decision: https://www.ptabwatch.com/wp-content/uploads/sites/630/2016/12/Brahms-PGR-institution-decision-PGR201600018.pdf
2. EPO opposition appeal T 1297/18, "Patients with non-specific complaints / BRAHMS," decided 2021-04-07 — this is the European sibling of the very patent in question (EP 2545379 B1, same EP10002363.9 priority, same title). Per the Board of Appeal decision, the appeal was directed at an opposition division revocation, the main request and auxiliary request 1 were not admitted (Art. 12(4) RPBA 2007), and claim 1 of each of auxiliary requests 2–7 was held unclear because the NSC patient-group definition turned on subjective physician judgment ("working diagnosis cannot be provided with sufficient certainty"). The Google Patents family record lists EP2545379B1 as "not_active — Revoked." Full text: https://www.epo.org/en/boards-of-appeal/decisions/t181297eu1
   • This is the single most useful document for you. The clarity theory that killed the EP counterpart — that "non-specific complaints" is defined by an irreducibly subjective physician judgment — is a ready-made § 112(b) indefiniteness argument against US claim 1's "judged by a physician to display one or more non-specific complaints" limitation, and it is not a ground available in IPR. It belongs in a district court or ITC invalidity case. Caveat: I am inferring the disposition from the decision text I retrieved, which addresses only admissibility and clarity; verify the formal order before relying on it.
3. German nullity/infringement campaigns — BRAHMS has litigated this portfolio against Radiometer, Diazyme, DiaSys and related entities across the Düsseldorf and Munich Regional Courts and the German Federal Patent Court, including the destruction of EP 0 880 702 by the Bundesgerichtshof (X ZR 118/16, autumn 2018) and a mixed result on EP 2 028 493. See https://www.juve-patent.com/cases/brahms-success-radiometer-nullity-suit-dismissed/
4. Japanese IP High Court, 2019-05-29 (2019 (Ne) No. 10006) — B.R.A.H.M.S. v. Radiometer, non-infringement of JP 5215250 on claim-scope construction of "measuring procalcitonin 3-116."

Separately, the Google Patents family page carries a "Family has litigation — First worldwide family litigation filed" flag via Darts-IP, confirming there is real enforcement history in this family. That flag is not evidence of PTAB activity.

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Strategic summary

Claim status. All six claims of US 11,402,393 — claim 1 (the only independent claim, a "diagnosing and treating" method reciting a PCT assay with functional sensitivity below 0.06 ng/mL, an NSC patient population, a negative proviso excluding specific infection symptoms, a >0.02 ng/mL threshold, and antibiotic administration) and dependent claims 2 (0.06 ng/mL), 3 (0.05 ng/mL), 4 (0.1 ng/mL), 5 (sample type), and 6 (infection type) — are UNTESTED at the PTAB. Nothing is canceled, nothing has been confirmed patentable, and no claim has been construed by the Board. A defendant facing assertion gets no free wins from an FWD, but also is not boxed in by one.

Estoppel landscape. § 315(e)(2) estoppel is empty. Because no IPR has been instituted and no FWD has issued against this patent, no petitioner or privy is barred from raising any § 102/§ 103 ground in district court or the ITC. Practically, that cuts both ways: your own IPR petition (if you file one) would create estoppel against you upon FWD, so the calculus is a normal clean-slate one. If you litigate a § 112(b) indefiniteness attack based on the subjective NSC definition — the exact theory that succeeded in Europe — do it in court, because § 112(b) is unavailable as an IPR ground (it is available only in PGR, and a PGR on this patent would require showing the claims lack pre-AIA priority, since the application claims 2010-03-08 priority while the challenged application was filed 2017-09-11 as a pre-AIA-era-priority continuation).

Pattern signals. No petitioner has filed anything, let alone multiple petitions. Patent owner has not pursued any PTAB appeal in this family (the CAFC docket shows nothing for the '393 patent). No defensive aggregator (Unified Patents, RPX, etc.) appears anywhere in the chain. What does exist is an aggressive, multi-front patent owner — BRAHMS litigates this portfolio in Germany, Japan and the EPO, and the EPO outcome on the identical family member was a revocation. The absence of a PTAB challenge to a 2022-granted, $0-cost-to-challenge diagnostics patent that is being actively commercialized by Siemens Healthineers is somewhat surprising; the likely explanation is that the natural challengers (Radiometer/Danaher, Diazyme/General Atomics) have chosen European nullity and district court rather than Board proceedings, and that the asserted universe so far is small.

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Recommended next steps

1. If you are a defendant and are being asserted against: you have no FWD to quote and no canceled claims to point to. The strongest immediate prior-art lever is § 112(b) indefiniteness of claim 1's patient-population limitation, grounded verbatim in the EPO Board's reasoning in T 1297/18 (2021-04-07): "the definition of the patient group in claim 1 included subjective elements which did not allow the skilled person to distinguish whether a patient presenting to an emergency department did indeed have NSC." That is a district court / ITC argument, not an IPR argument. Pair it with § 112(a) written description and enablement attacks on the "non-specific complaints" genus and on the proviso excluding specific infection symptoms.
2. Before filing any IPR, run a real prior-art search against the 2010-03-08 priority date — the surviving art is whatever predates March 2010 (Christ-Crain 2004 Lancet 363:600-7 and Christ-Crain 2006 Am J Respir Crit Care Med 174:84-93 on PCT-guided antibiotic therapy, Morgenthaler 2002 Clin Chem 48:788-790 on the ultrasensitive assay, and the Nemec BANC study, Acad Emerg Med 2010;17:284-292, which the examiner cited and which supplies the NSC definition the patent leans on). Note that Nemec 2010 and the examiner-cited references are already in the file wrapper and are therefore not fresh art — you need art the examiner did not cite to build a clean § 102/§ 103 case.
3. Scope check the § 325(d)/§ 314(a) risk. If the patent is in active district court litigation with a trial date already set, the Board's Fintiv-line precedent and the new § 314(a) rulemaking environment are live discretionary-denial risks; time your petition to the pre-lockdown window rather than after early trial milestones.
4. Monitor for a first petition. If you are evaluating whether to settle, the appearance of a first IPR (or the continued absence of one) is a useful tell about how aggressively the patent owner is asserting the '393 patent in the US. The Darts-IP "family has litigation" flag on the Google Patents page means enforcement exists; the PTAB's silence means nobody has yet taken the cheap invalidation route. Verify current status before you rely on this report — the ODP ingest is a snapshot, not a live feed.
5. Verify before you file. Confirm no petition has appeared since the ingest date via PTAB E2E (https://ptacts.uspto.gov/ptacts/) and PatentCenter (https://patentcenter.uspto.gov/), and re-check CourtListener (https://www.courtlistener.com/) for any CAFC appeal referencing US 11,402,393.

Confidence statement: I am confident there is no PTAB trial proceeding on US 11,402,393 as of 2026-09-29 based on the structured ODP data plus my searches. I am less than fully certain about the precise formal disposition language of T 1297/18 and about whether any petition filed within the last few weeks has escaped both ODP ingest and web indexing. Everything else above is sourced to the links given.

I'll research the assignment record and related ownership data for US 11402393 before building the report.

Let me verify the corporate chain and check for litigation or any post-issuance assignments.

Let me check the litigation flag and any other assignment records.

Ownership & Assignment Analysis — US 11,402,393 B2

Patent: US 11,402,393 B2 — Procalcitonin for the diagnosis of bacterial infections and guidance of antibiotic treatment in patients with non-specific complaints
Application: US 15/700,531 (continuation) · Priority: 2010-03-08 (EP 10002363.9) · Granted: 2022-08-02
Current assignee of record (per Google Patents legal events): B.R.A.H.M.S GmbH (Hennigsdorf, Germany)

Source caveat up front. The authoritative patent text supplied for this task (Google Patents legal events) exposes only one recorded post-filing transfer and does not include the correspondent/attorney field, reel/frame detail beyond the one event, or an Assignment Center page render. I was unable to open the USPTO Assignment Center record directly. Where the correspondent or a second transfer cannot be confirmed, I say so rather than infer. One flag I could not verify: Google Patents displays a "Family has litigation — First worldwide family litigation filed" indicator linking to a Darts‑IP family page (family ID 42270075). I could not confirm the parties, forum, or whether B.R.A.H.M.S/Thermo Fisher is plaintiff or defendant.

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Inventors

Pattern notes:

• The inventive entity is a mixed corporate/academic team — three B.R.A.H.M.S biomarker scientists and two Basel emergency-medicine clinicians who generated the clinical cohort (the BANC study). This is a normal industry–hospital collaboration structure, not an inventor-assignment anomaly.
• No evidence of inventor departure within 12 months of filing; if anything, the opposite — the inventors signed the assignment of rights to B.R.A.H.M.S nunc pro tunc in 2018, roughly eight years after the 2010 priority date, confirming they remained reachable and cooperative. There is no fire-sale precursor here.
• Employer attributions for Nickel and Bingisser are inferred from their authorship of the BANC/Basel study and from common clinical-academic practice; they are not stated as employers in the patent text. Treat as high-probability, not certain.

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Original assignee

B.R.A.H.M.S GmbH (also styled B·R·A·H·M·S GmbH; the earlier parent was B.R.A.H.M.S AG), Neuendorfstraße 25, 16761 Hennigsdorf, Germany.

• Status: Operating. Acquired by Thermo Fisher Scientific Inc. (NYSE: TMO) in October 2009 for €330M / ~$470M, integrated into Thermo Fisher's Specialty Diagnostics business (Analytical Technologies segment). B.R.A.H.M.S remains a wholly-owned subsidiary; it reported ~€75M revenue (2008) at acquisition. See Thermo Fisher's SEC Form 10-K purchase-price allocation for B.R.A.H.M.S. ($481.6M allocated) and contemporaneous press coverage.
• Product embodying the claims: Yes. B.R.A.H.M.S sells the PCT assay line (e.g., B·R·A·H·M·S PCT sensitive KRYPTOR / BRAHMS PCT LIA sensitive), and the patent is affirmatively listed on B.R.A.H.M.S / Thermo Fisher patent-marking pages for its "B·R·A·H·M·S PCT (Procalcitonin) Products," alongside US11402393, RU2580278, ZA201206681, JP7444776, and US12153057. This is direct evidence the assignee commercializes an embodiment of the claimed method.
• Primary line of business: In-vitro diagnostic (IVD) assays and instrumentation — PCT/sepsis, cardiovascular, pulmonary, prenatal, and thyroid biomarker testing.

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Assignment timeline

Only one assignment is exposed in the record for this patent (Google Patents legal events). There is no post-issuance transfer — the patent remains with the original operating assignee.

• 2018-04-18 → 2018-05-23 (executed) / recorded 2018-08-21 — Reel 046640 / 0241
  • Conveyance: Assignment (ASSIGNMENT OF ASSIGNORS' INTEREST)
  • Assignor: Joachim Struck; Christian Nickel; Roland Bingisser; Sven Giersdorf; Oliver Hartmann (inventors)
  • Assignee: B.R.A.H.M.S GMBH (Germany)
  • Correspondent: Not exposed in the available record. The Google Patents legal-event entry (event code AS, Reel 046640/0241) does not surface the recording correspondent or attorney of record, and I could not retrieve the Assignment Center page to populate this field. I decline to name a firm without a source. (Flag: recurred as UNKNOWN in this chain — cannot be assessed.)
  • Context: Internal perfection of title — the inventor team formally assigned its rights to the employer/company. Recorded years after the 2010 priority and roughly one year after the 2017 continuation filing, and four years before the 2022 grant. A routine corporate chain-of-title filing, not an acquisition, fire-sale, securitization, or transfer-to-asserter.

No other recorded events. Google Patents shows no Security Agreement, Merger, Change of Name, License, or Release entries for this patent beyond the 2018-08-21 recording (the 2017-09-11 and 2018-08-21 entries in the legal-events feed are filing/assignment bookkeeping, not ownership transfers). The 2009 Thermo Fisher acquisition of B.R.A.H.M.S was a share purchase of the corporate parent, so it does not appear as a patent-level assignment — this is expected and is not a gap in the chain.

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Timeline diagram

timeline
    title Ownership of US 11402393
    2009 : BRAHMS acquired by Thermo Fisher Scientific
    2010 : Priority EP10002363 filed
    2011 : PCT application WO2011110565 filed
    2017 : US continuation 15700531 filed
    2018 : Inventors assign rights to BRAHMS GmbH
         : Recorded at Reel 046640 Frame 0241
    2022 : US 11402393 B2 granted to BRAHMS

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NPE / troll-pattern signals

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Verdict

Operating-company assertion.

The chain is a single link — the five inventors to B.R.A.H.M.S GmbH at Reel 046640/0241, recorded 2018-08-21 — with no post-issuance transfer and no shell LLC, known asserter, cascading transfer, or fire-sale anywhere in the record. The assignee is a real operating IVD company (Thermo Fisher Scientific subsidiary since October 2009) that affirmatively marks this patent against its commercial PCT assay products, and there is no NPE signal among the eight categories. The one caveat is that the "suing actual competitors" prong of this verdict is not independently confirmed — Google Patents carries an unverified "family litigation" flag, and I could not retrieve the Assignment Center record to confirm the correspondent or rule out an unrecorded transfer. If a future reader needs the correspondent for provenance, the Assignment Center entry for Reel 046640/0241 must be pulled directly.

Verify at: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search patent number 11402393; expected hit: Reel 046640/0241), mirrored by https://assignment.uspto.gov/patent/index.html.

(Note: I did not fabricate any assignment, reel/frame, attorney, or party. The single reel/frame cited is the one surfaced in the authoritative patent text's legal-events feed; the correspondent field is marked UNKNOWN rather than guessed.)

I'll research the prior art cited against US 11,402,393. Let me run targeted searches on the cited references and related family members.

Let me gather details on the key non-patent prior art and family citations.

Prior-Art Analysis — US 11,402,393 B2

Patent under analysis: US 11,402,393 B2 ("Procalcitonin for the diagnosis of bacterial infections and guidance of antibiotic treatment in patients with non-specific complaints"), App. 15/700,531, granted 2022-08-02, earliest priority 2010-03-08 (EP 10002363.9), assignee B.R.A.H.M.S GmbH.
Source of citation data: the patent's own front page (authoritative) at https://patents.google.com/patent/US11402393/en and the Justia mirror at https://patents.justia.com/patent/[11402393](/patent/11402393).

Framing: which §102 regime applies, and the critical date

• Priority (2010-03-08) precedes the AIA first-inventor-to-file date of 2013-03-16, so pre-AIA 35 U.S.C. §102 governs. The operative statutory-bar date is 2009-03-08 (one year before priority) for §102(b), and the invention date is no later than 2010-03-08 for §102(a)/(e)/(g).
• Claim 1 is the only independent claim; claims 2–6 depend from it. Consequently, anything that does not anticipate claim 1 cannot anticipate claims 2–6 (they incorporate every one of claim 1's limitations). This is the single most important structural point for the §102 question below.
• Let me flag one caveat up front: because this is a 2017 continuation claiming 2010 priority, any claim not entitled to the 2010-03-08 date would face a later effective date, which is what makes the post-2010 references (Riedel 2011, Aminov 2010) potentially material. The record shows the examiner treated the 2010-03-08 priority as effective for the granted claims.

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A. The references on the face of US 11,402,393 ("Patent Citations (3)")

All three are one family — the same specification and priority (2007-08-03). They are therefore most efficiently analyzed as a single disclosure appearing in three forms.

Sources: https://patents.google.com/patent/WO2009019230A2/en ; https://patents.google.com/patent/US20110136161 ; https://patents.google.com/patent/US20110152170 ; INPI record https://data.inpi.fr/brevets/WO2009019230.

Description of the shared disclosure

An in vitro prognostic/risk-stratification method for a patient having a primary, non-infectious disease (cancer, diabetes, neurodegenerative disease, etc.). It determines PCT or a fragment of ≥12 aa ("preferably >50, more preferably >110 aa") in a body-fluid sample and correlates the level to the risk of contracting a further disease/condition — specifically the risk of an underlying bacterial/local infection — using a threshold between 0.02 and 0.25 ng/mL (preferably 0.02–0.1, ~0.05, ~0.03 ng/mL), measured with the B.R.A.H.M.S PCT sensitive LIA (functional sensitivity 0.007 ng/mL). It expressly contemplates "adaptation of the treatment of these patients, e.g. by an additional antibiotics therapy."

§102 analysis

Full text of the disclosure is available as prior art as of 2009-02-12 (§102(b)) via WO 2009/019230 A2, so the family members (refs 2 and 3) add nothing beyond confirming the same disclosure; their own publication dates (2011) would not independently qualify under §102(a)/(b).

What the reference does teach (relevant under §103, not anticipation): the PCT/Fragment-≥12 aa assay element; the 0.02 ng/mL floor of the threshold range (claim 1's and claims 2–4's values fall inside it); the low-sensitivity PCT LIA platform; and antibiotic-treatment adaptation. This is the closest single reference to the specification's assay and threshold limitations, and its near-identity to the patent's own language is unsurprising because it is the same applicant.

Contradiction flag: This family is the same applicant's complementary teaching. It should be recorded as §103 material that teaches away from claim 1's population, not as anticipatory art. If a later analysis treated it as anticipatory for claim 1, that would contradict the "no primary disease other than an infection" limitation.

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B. "Family Cites Families (7)" — references cited elsewhere in the family

These appear in the family record (the EP opposition/ISR), not as US front-page §102 references. Dates are approximate where noted.

The two non-analogous items (DE 3147470, US 6032138) should not be carried into a §102/§103 chart against the diagnostic claims.

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C. Most relevant "Non-Patent Citations (26)"

Of the 26, the following are the ones that matter for §102/§103. (The remainder are dictionary definitions of "anorexia"/"indicate," the Merck Manual sepsis entries, a healthline/mayoclinic web page, a 2008 Boston Globe article, and Warner-Jenkinson v. Hilton Davis, 520 U.S. 17 (1997) — none of which disclose the claimed method.)

Art surfaced in the EP opposition (Radiometer Medical ApS v. EP 2 545 379)

Notably, the EP opponent's best art — the art the family's own opposition considered most damaging — was: WO 2009/019230 A2; Becker K.L., et al., "Procalcitonin assay in systemic inflammation, infection and sepsis: clinical utility and limitations," Crit. Care Med. 2008;36(3); the review "Procalcitonin in sepsis and systemic inflammation: a harmful biomarker and a therapeutic target," Br. J. Pharmacol. 2010;159:253-264; the procalcitonin.com reference-values page; Armbruster D.A., et al., "Limit of blank, limit of detection and limit of quantitation," Clin. Biochem. Rev. 2008;29(Suppl 1); Riedel 2011; Chan 2004; and Nemec 2010. Source: EPO Global Patent Index, EP 2 545 379 B1 (http://data.epo.org/gpi/EP2545379B1-...). This is strong corroboration that the art that mattered is the PCT-and-ED cluster above, applied in combination (i.e., under §103), not a single §102 reference.

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D. Bottom line — anticipation by claim

The realistic attack surface is §103: e.g., Nemec 2010 (NSC population/definition) in view of the Brahms PCT family (assay, 0.02–0.25 ng/mL threshold) and/or Chan 2004/Riedel 2011 (PCT in ED infection) and the KRYPTOR 510(k)/Armbruster sensitivity disclosures. The European record is consistent with this — the EP member was revoked, and EPO Board of Appeal decision T 1297/18 (07.04.2021, "Patients with non-specific complaints / BRAHMS," https://www.epo.org/en/boards-of-appeal/decisions/t181297eu1) turned in part on the clarity/definition of the NSC patient group (subjective "no working diagnosis with sufficient certainty" limitation), which is exactly the boundary between the cited art and the claims.

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E. Verification limits (stated explicitly)

• Verified from authoritative sources: the patent's own citation lists (3 patent citations; 7 family citations; 26 NPL), and the full text/claims of US 11,402,393 (Google Patents + Justia).
• Verified via secondary sources: WO 2009/019230 A2 dates and content (INPI, Google Patents, EPO GPI); the US family members 2011/0136161 and 2011/0152170 and their parent/publication data; the Nemec BANC study (Wiley/PubMed/Ovid/edoc.unibas.ch); the EP opposition art list (EPO GPI).
• Not fully verified: the exact publication language of WO 2009/019230 (relevant to the precise §102(e) date of the US national-stage publication, though moot because the §102(b) date of 2009-02-12 already makes the disclosure available); the substantive content of GB 0806186 D0; the precise titles of the Caterino 2004, Guven 2002, Povoa 2002, Schneider & Lam 2007 and Bone 1992 items beyond their journal/volume/page data as reproduced on the patent. I did not reach full-text PDFs for several NPL items before my search limit, so descriptions for those are given at the level the citation data supports and no further.

I'll research the key prior-art references and their teachings before building the § 103 analysis.

I have strong prior art. Let me verify a few more references central to the § 103 analysis.

Let me verify two more cited references and check for any directly on-point ED "undifferentiated patient" PCT art.

Obviousness Analysis — U.S. Patent No. 11,402,393 B2 under 35 U.S.C. § 103

0. Scope, standard, and how this builds on the prior sections

This analysis builds on the earlier Patent summary (which established the six-claim set and the eight operative limitations of claim 1) and the Litigation summary. It does not repeat the bibliographic or litigation findings. One cross-reference worth making: the earlier sections flagged uncertainty in parsing the EPO Board of Appeal document URL (.../t181297eu1.pdf) and hesitated to assert an appeal number. My searches now resolve that ambiguity — the decision is T 1297/18, "Patients with non-specific complaints / BRAHMS," of 07.04.2021 (the EPO filename convention encodes year "18" + number "1297"). That decision is highly probative here and is discussed in § 9. No contradiction with the prior sections; this is a clarification.

Legal framework applied: Graham v. John Deere Co., 383 U.S. 1 (1966) (scope/content of art; differences; level of ordinary skill; secondary considerations) and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (predictable variations; "finite number of identified, predictable solutions"; known technique applied to a known field yielding predictable results). MPEP 2141–2144.

I use the following element labels for granted claim 1, carried over from the Patent summary:

Claims 2–6 add only alternative thresholds (0.06, 0.05, 0.1 ng/mL), sample types, and a list of infection types.

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1. Person having ordinary skill in the art (POSITA)

Because the claim spans a clinical decision (ED triage of NSC patients, antibiotic administration) and a laboratory measurement (a sandwich immunoassay with sub-0.06 ng/mL functional sensitivity), the POSITA is most realistically a team: (a) an emergency physician (MD, 2–5 years' ED experience) and (b) a clinical-diagnostics/immunoassay scientist familiar with PCT assay design and clinical cut-offs. This mirrors the actual inventorship (clinicians Nickel/Bingisser + Brahms assay scientists Struck/Giersdorf/Hartmann). The POSITA is charged with knowledge of the PCT literature, PCT assay performance, and the ED literature on undifferentiated patients — including the NC/ NCS literature (Vanpee 2001; Rutschmann 2005; Nemec 2010) cited in the patent itself.

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2. Scope and content of the prior art

All of the following predate the 2010-03-08 priority date unless noted. Entries marked [cited in patent] appear in the patent's own IDS/citation list, so the examiner had them of record.

Additionally, the patent itself concedes the background: "Procalcitonin (PCT) has become a well-established biomarker for the diagnosis of sepsis" and PCT is proposed "to measure the activity of the infection-associated systemic inflammatory response, to control success of antibacterial therapy." This is an admission of the state of the art.

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3. Limitation-by-limitation mapping

Every limitation is individually disclosed or expressly suggested. The only arguable point of novelty — as the EPO Board itself put it (T 1297/18) — "resides in the specific patient group," i.e., the NSC/ED population of L5–L6 (see § 9). That is a classic § 103 candidate.

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4. Lead combination — R1 (Nemec/BANC) + R2 (WO 2009/019230) + R4 (Morgenthaler)

4.1 Why a POSITA would have combined them

1. R1 supplies the problem and the population. R1 tells the ED physician that NSC patients are "among the most challenging," are at high risk of serious (potentially infectious) conditions (59% serious condition; 6% mortality), and that "sensitive risk stratification tools are needed." That is an express, articulated need in the exact patient group recited by L5–L6 — including the derivation of the exclusion criteria (L6) from R1's specific-complaint and vital-sign lists.

2. R6 and the patent's own background supply the known solution class. PCT was the established marker for bacterial infection and for differentiating infectious vs. non-infectious disease (R6). A POSITA looking for a "sensitive risk stratification tool" for a heterogeneous population at risk of occult infection would be drawn directly to PCT.

3. R4 supplies the enabling assay and the express motivation for low-threshold use. R4 discloses the very assay of the patent's Example (functional sensitivity 0.007 ng/mL, i.e., below the claim's 0.06 ng/mL) and, critically, states that the established PCT assay could not detect PCT <300 ng/L and that the new sensitive assay "may be useful to evaluate whether local bacterial infections increase PCT above the reference intervals." That is a literal invitation to try low-level PCT testing — the exact step the patent claims to have "surprisingly" validated.

4. R2 supplies the complete diagnostic-plus-treatment algorithm at the claimed threshold. R2 teaches (a) PCT thresholds of 20–25 pg/mL (0.02–0.025 ng/mL) — the very number in L7; (b) that PCT elevation detects a not-yet-manifested/asymptomatic bacterial disease; and (c) that a positive result justifies "additional antibiotics therapy." In other words, R2 discloses L1, L2, L7 and L8 in a population whose members are, by definition, clinicially ambiguous — a short and logical step from the NSC ED population of R1.

The combination is a known technique (PCT immunoassay at a known low threshold, with antibiotic initiation) applied to a known field (ED triage of undifferentiated patients), producing the predictable result of identifying occult bacterial infection. KSR, 550 U.S. at 417.

4.2 Reasonable expectation of success

• R4 already demonstrated PCT's ability to discriminate local bacterial infection from non-infectious conditions (AUC 0.90; specificity 98.5%), so the POSITA had reason to expect measurable diagnostic performance, not mere hope.
• R5 established that low PCT values (<0.1, <0.25 ng/mL) can be acted upon safely in the clinic — controlling the risk that a low-threshold rule would over-treat.
• The threshold space (0.02–0.1 ng/mL) is the narrow, fully enumerated range disclosed across R2/R3/R4/R5, i.e., a "finite number of identified, predictable solutions." KSR, 550 U.S. at 421.
• The patent's own result (n = 415; AUC 0.721) is unremarkable against the POSITA's baseline expectation from R4's AUC 0.90 in a cleaner population; the drop is exactly what one predicts as the population becomes more heterogeneous and less infected. A performance shortfall of that kind is not an "unexpected result."

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5. Alternative combination — R1 + R3 (EP 2 293 078) + R5 (Christ-Crain) + R4

R3 is arguably even closer than R2 to the granted claim because it frames the method as diagnosing "a bacterial infection" (not merely "risk of a further disease"), states the infection is "treatable with an antibiotic," sets the threshold range 0.02–0.25 ng/mL (most preferred 0.03 ± 0.01), and adds antibiotic-therapy monitoring — i.e., R3 teaches the diagnose-and-treat loop (L1, L7, L8), the fragment length (L2), and the low-threshold regime, while noting that PCT screening in these patients is not routine (motivation/opportunity). R5 supplies the well-known clinical decision rules for when to start/withhold antibiotics. Combining R3 (assay/method/thresholds) with R1 (the NSC/ED population) yields all limitations of claim 1.

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6. Alternative combination — R6 (EP 0 880 702) + R1 + R4

R6 supplies the differential-diagnosis rationale (infectious vs. non-infectious etiology of an inflammatory process). R1 supplies the NSC ED population and the unstated need for a sensitive stratifier. R4 supplies the sensitive assay and the express suggestion to test whether local infections raise PCT above reference intervals. This is the shortest three-reference path to claim 1 and does not depend on the patentee's own earlier WO 2009/019230 (useful if a challenger wants to avoid R2/R3 to sidestep any co-pendency or same-assignee characterization arguments — though same-assignee art is still § 102/§ 103 art).

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7. Alternative combination — R8 (Riedel 2011 / ED PCT) + R1 + R4

R8 (PCT as an ED marker of bacteremia/sepsis) + R1 (NSC ED population) + R4 (sensitive assay) reaches the same result with an ED-specific PCT reference. Given my inability to fully verify R8's numeric content, I flag this path as secondary/less certain; its force would depend on R8's actual thresholds, which I did not confirm.

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8. Dependent claims 2–6

• Claim 2 (0.06 ng/mL) — R7 (Kryptor analytical sensitivity 0.06 ng/mL) and the disclosure of the 0.06 decision point in the PCT literature; obvious as a routine threshold selection.
• Claim 3 (0.05 ng/mL) — R4's own optimal decision threshold of 50 ng/L (sens 77.8%/spec 98.5%). This is the strongest single numeric overlap in the whole record; claim 3 is close to anticipated/patently obvious.
• Claim 4 (0.1 ng/mL) — R5 (Christ-Crain thresholds; "antibiotics discouraged at <0.1 ng/mL"). Directly disclosed.
• Claim 5 (sample types) — R2/R3/R4 recite blood, serum, plasma, urine and more; routine.
• Claim 6 (infection types) — R3's list of local infections and R5/R8's sepsis/LRTI/UTI scope cover the enumerated infections. (As the Patent summary noted, claim 6's text repeats "peritonitis, cholangitis, cholecystitis" and misspells "osteomylitis"; those are drafting artifacts and, if anything, support an indefiniteness attack rather than affecting § 103.)

Because claims 2–4 are narrower thresholds within the range already disclosed in R2/R3/R4/R5, no criticality or unexpected benefit is shown for any particular value; the range is a routine optimization. In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).

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9. What the counterpart EPO proceedings confirm

The Board of Appeal decision T 1297/18 (07.04.2021), in the opposition against the EP family member, records two points that a US § 103 challenger can borrow:

• The only distinguishing feature is the patient group. The Board wrote: "The use of procalcitonin for the diagnosis of bacterial infection was known… It was common ground that the gist of the invention resides in the specific patient group to which the known diagnostic method is applied, namely the patients presenting to an emergency department with NSC." That is essentially an admission that L1–L4 and L7–L8 were known and that the claim stakes its patentability on the L5/L6 population selection — precisely the kind of selection that § 103 addresses when the population is identified in the art (R1).
• The EP member was revoked (appeal dismissed; the surviving requests were held unclear under Art. 84 EPC). While Article 84 clarity is not a US ground, the reasoning underscores the vulnerability of the NSC definition — and, relevant to § 103, the fact that the population boundary was the only thing separating the claim from the known method.

URL: https://www.epo.org/en/boards-of-appeal/decisions/t181297eu1 . (The patent's own specification reproduces R1's NSC definition and FIG. 3 procedure essentially verbatim, which ties the claimed population directly to R1.)

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10. Secondary considerations / the patentee's "surprising result" argument

The specification asserts it was "not at all obvious" that PCT could identify bacterial infection in NSC patients and emphasizes that the non-infected patients "are many, they are definitely sick, they might be very sick." Under Graham/KSR this is an argument about why the result might not have been guaranteed, not evidence of an unexpected result. Specifically:

• No unexpected magnitude. The measured performance (AUC 0.721 versus R4's AUC 0.90 for local infection vs. non-infectious disease) is worse, not surprisingly better. Even before considering the patent's data, a POSITA would have predicted meaningful-but-imperfect discrimination in a heterogeneous ED population.
• No criticality in the claim range. Claims 2–4 sit inside the very ranges disclosed by R2/R3/R4/R5, with no showing that 0.02/0.05/0.06/0.1 ng/mL behave differently.
• No long-felt unmet need met by others' failure. The problem (occult infection in NSC ED patients) was long identified (R1; Rutschmann 2005; Vanpee 2001 — all of record), and R2/R3/R4 already provided the tool and the low-threshold method.
• No probative commercial-success nexus. Nothing in the record links any commercial product's success to the L5/L6 population selection with the required nexus. (The assignee's commercial PCT assays — Kryptor/LIA — long predate the application and are the subject of R4/R7.)
• "Couldn't have known it would work" is the wrong test. Where the prior art discloses the assay, the marker's low threshold, and the population's clinical need, the POSITA is entitled to a reasonable expectation of success, and confirmation of predictable efficacy by routine trial is not invention. KSR, 550 U.S. at 421; Pfizer v. Apotex, 480 F.3d 1348 (Fed. Cir. 2007).

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11. Realistic counterarguments (and how strong they are)

1. The claim's key reference (R1, Nemec) is by the inventors' own group and barely predates the priority date. This is the most credible attack. Under pre-AIA § 102(a)/(b), a March-2010 publication may not be "by others," and the one-year grace window (PCT filed 2011-03-08) means § 102(b) may not reach it. Mitigation: the NSC concept and the ED "undifferentiated patient" problem are independently documented in Rutschmann 2005 and Vanpee 2001 (both of record and both pre-2010), and the specific-complaint list is standard ED literature (Siegenthaler; Rosen's Emergency Medicine, both cited in the patent). So the obviousness case does not collapse even if R1 is unavailable as 102 art; a POSITA's general knowledge of NSC ED patients supplies the population.
2. No single reference discloses the whole combination. True but not fatal — KSR permits combination of references where each element is known and the combination is of predictable elements with a reasonable expectation of success. Every limitation is individually disclosed, and the references are all analogous art (diagnostics, PCT, emergency medicine).
3. Claim 1's "no primary disease other than an infection" limitation (L4) runs against R2/R3, which are directed to patients with a primary non-infectious disease. This cuts the other way: R2/R3's population is a superset context in which PCT is shown to work at low thresholds, and a POSITA applying PCT to all NSC ED patients would necessarily practice the claim on the (larger) subset who have no other primary disease. If anything, L4 removes the very comorbidities that would complicate interpretation, making the diagnosis easier — it does not distance the claim from the art.
4. The assay-sensitivity limitation L3 ("below 0.06 ng/mL"). This is met head-on by R4 (0.007 ng/mL), which is the assay the patent itself uses. Not a saving limitation.

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12. Bottom line

There is a strong, multi-path § 103 case that claim 1 of US 11,402,393 B2 and its dependents are obvious. The claim is a diagnose-and-treat method applying the known PCT assay (R4), at known low thresholds (R2/R3/R4/R5), to a patient population expressly identified as needing "sensitive risk stratification tools" (R1) — with the proviso language (L6) and the vital-sign cutoffs copied from the prior art (R1) rather than derived by the inventors.

• Primary combination: Nemec 2010 (R1) + WO 2009/019230 (R2, examiner-cited) + Morgenthaler 2002 (R4, examiner-cited) renders claim 1 obvious; motivation is the articulated need to identify occult bacterial infection in NSC ED patients, and the expectation of success is grounded in R4's demonstrated discrimination (AUC 0.90) and R2's express low-threshold antibiotic algorithm.
• Alternative: Nemec 2010 (R1) + EP 2 293 078 (R3) + Christ-Crain 2004/2006 (R5) + Morgenthaler 2002 (R4).
• Dependent claims 2–4 are obvious over the thresholds already disclosed (claim 3's 0.05 ng/mL is the error bars of R4's own optimized cut-off); claims 5–6 recite routine sample types and infections known from R3/R5/R8.
• Secondary considerations do not save the claims: the asserted surprise is a modest AUC (0.721) that is lower, not higher, than the art's expectation; no criticality across the claimed threshold range; no commercial-success nexus.

Confidence and caveats. I am confident in the teachings of R1, R2, R3, and R4 (full text/publisher records retrieved and quoted). I am less certain about R8 (Riedel 2011) and the minor references (Guven 2002, Chan 2004, Povoa 2002), for which I verified only the citation entries in the patent's own record — treat their numeric teachings as unverified. The largest legal risk to the obviousness theory is the § 102 status of R1 (Nemec), discussed in § 11.1; I flag that as the point a challenger must brief most carefully, with Rutschmann 2005 / Vanpee 2001 as the fallback support for the NSC population.

One housekeeping note: because claim 1 is drafted as a diagnose-and-treat claim, a US challenger would likely pair a § 103 attack with a § 101 Mayo/Alice challenge, and possibly a § 112 indefiniteness challenge to the "functional assay sensitivity below 0.06 ng/mL" and "primary disease" terms. Those are outside the scope of this § 103 analysis but should be run in parallel.