{"schema_version":1,"experiment_id":"eoa_inverse_innovation_exp12_substrate_denial72_20260805","research_id":"eoa_inverse_innovation_exp12_light_screen_20260805","cell_id":"substrate_lineage_risk_audit__chemistry_materials","search_lanes":{"direct_problem_and_intervention":{"queries":["reclaimed recovered solvent trace impurities water metals distillation reuse pharmaceutical synthesis","reclaimed solvent adsorbent polishing column reuse impurities","\"Self-Recording Chemical Guard Train\" solvent"],"source_ids":["SRC1","SRC2"],"no_result_note":"The exact-title search produced no relevant match; that phrase miss was not treated as novelty evidence."},"synonyms_and_historical_terms":{"queries":["recycled solvent quality specification pharmaceutical residual impurities ICH recovered solvents reuse","\"spent solvent\" purification guard bed impurities reuse","\"redistilled solvent\" trace impurities moisture sensitive synthesis","\"organic volatile impurities\" recovered solvent reuse"],"source_ids":["SRC1","SRC2"],"no_result_note":null},"products_practices_and_standards":{"queries":["solvent purification system guard column molecular sieve activated alumina ion exchange metal scavenger organic solvent","metal scavenger cartridge organic solvent flow through silica thiol product","indicator molecular sieve color change water loading solvent cartridge product"],"source_ids":["SRC1","SRC4"],"no_result_note":null},"component_combination":{"queries":["patent multi-stage cartridge purification organic solvent molecular sieve ion exchange metal scavenger","organic solvent purifier cartridge multiple adsorbent beds acid water metal removal product","segmented cartridge solvent purification color indicator desiccant acid scavenger metal scavenger"],"source_ids":["SRC3","SRC4"],"no_result_note":null}},"sources":[{"source_id":"SRC1","title":"Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","source_type":"OFFICIAL_GUIDANCE","claims_supported":["Recovered solvents may be reused only when recovery is controlled and monitored and the solvents meet standards appropriate to their intended use.","Fresh and recovered solvents may be combined only after adequate suitability testing.","Recovered-solvent use should be documented, establishing qualification and traceability as existing practice."]},{"source_id":"SRC2","title":"Mylan Laboratories Limited – Unit 7, Warning Letter 607508","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mylan-laboratories-limited-unit-7-607508-08202020","source_type":"OTHER","claims_supported":["FDA observed unknown peaks in recovered-solvent chromatograms and found that the solvent-recovery process had not been adequately evaluated as their source.","FDA requested monitoring of unanticipated impurities and impurity-profile risk assessment for all solvent-recovery operations.","The letter reports that poor recovered-solvent controls at another facility led to drug contamination through impurity carryover."]},{"source_id":"SRC3","title":"US12043592B2 — Systems and methods for purifying solvents","publisher":"Google Patents / United States patent publication","url":"https://patents.google.com/patent/US12043592B2/en","source_type":"OTHER","claims_supported":["Prior art combines molecular-sieve dehydration, filtration, distillation, and downstream ion-exchange filtration for organic-solvent purification.","The disclosed serial ion-exchange filters target different metal classes after distillation.","The system explicitly addresses moisture, organic impurities, metallic impurities, and the risk of introducing unwanted substances."]},{"source_id":"SRC4","title":"SiliCycle Chemistry Reference Poster — E-PAK Flow Purification Cartridges","publisher":"SiliCycle Inc.","url":"https://www.silicycle.com/media/pdf/silicycle-chemistry-reference-poster.pdf","source_type":"FIRST_PARTY_PRODUCT","claims_supported":["Commercial radial flow-through adsorption cartridges are offered for pharmaceutical processing from laboratory through commercial scale.","Available cartridge media include metal and organic scavengers, silica, Florisil, and activated carbon.","Flow-through scavenger cartridges therefore establish practical component-level precedent for solvent-compatible contaminant capture."]}],"problem_evidence":{"status":"PARTLY_SUPPORTED","finding":"The core problem is visible: official guidance requires recovered-solvent control, testing, and documentation, and an FDA enforcement record documents unknown recovered-solvent impurities and actual contamination associated with poor controls. The retained evidence does not independently establish the proposal's entire enumerated bundle of water, acid, base, metal, heat, gas, selectivity, and decomposition outcomes in moisture-sensitive syntheses.","source_ids":["SRC1","SRC2","SRC3"]},"closest_prior_art":[{"name":"US12043592B2 multi-stage organic-solvent purification system","source_ids":["SRC3"],"overlap":"Uses ordered solvent-contacting operations including molecular-sieve dehydration and distinct serial ion-exchange filters to remove moisture, organic impurities, and different metal classes around a distillation step.","remaining_difference":"It targets semiconductor-grade solvent rather than inherited risk in reclaimed synthesis solvent, and the retained disclosure does not describe a transparent, separable acid/base/water/metal/polar guard train whose axial loading pattern serves as a class-resolved material record."},{"name":"SiliCycle E-PAK flow purification cartridges","source_ids":["SRC4"],"overlap":"Provides first-party flow-through cartridges containing metal or organic scavengers and other adsorbents for pharmaceutical processing.","remaining_difference":"The source presents cartridge-media options but not the proposed ordered multi-class train, interstage breakthrough measurements, or spatial loading record tied to reclaimed-solvent lineage."},{"name":"ICH Q7 recovered-solvent qualification practice","source_ids":["SRC1","SRC2"],"overlap":"Requires controlled recovery, standards appropriate to intended use, testing, impurity assessment, and documentation before reuse.","remaining_difference":"This is qualification and governance prior art rather than continuous upstream molecular interception; it does not itself capture contaminants or preserve a physical class-specific loading trace."}],"prior_art_disposition":"ADJACENT_PRIOR_ART","contrastive_claim_remaining":"Relative to established recovered-solvent qualification and existing multi-stage purifiers, the remaining testable claim is that a solvent-compatible, physically separated guard train placed after recovery and immediately before a sensitive synthesis can simultaneously reduce predefined water, acid/base, metal, and polar-residue challenges while producing reproducible stage-specific loading or front patterns that identify contaminant class coarsely, without harmful leaching, solvent alteration, or breakthrough. The claim does not extend to unique provenance reconstruction or contaminants outside the selected media envelope.","contrastive_claim_falsifier":"The claim is falsified if an existing public source shows the same reclaimed-solvent, multi-class, spatially self-recording guard arrangement, or if controlled testing finds that stage patterns do not track challenge class or loading, targeted contaminants are not reduced versus untreated solvent, an unsegmented purifier performs equivalently, or the train introduces consequential leachables, heat, pressure, solvent-composition changes, or reaction interference.","gates":{"adequate_source_search":{"status":"PASS","rationale":"The bounded search covered the proposal directly, recovered/spent/redistilled-solvent terminology, older organic-volatile-impurity terminology, official reuse controls, commercial scavenger cartridges, and combinations of molecular sieves, adsorbents, ion exchange, metal scavenging, distillation, and segmented purification. Exactly four opened sources from three publisher groupings were retained.","source_ids":["SRC1","SRC2","SRC3","SRC4"]},"supported_problem":{"status":"PASS","rationale":"Official guidance recognizes recovered solvent as requiring use-specific control and testing, while FDA enforcement evidence documents unknown impurities and contamination associated with inadequate recovered-solvent controls.","source_ids":["SRC1","SRC2"]},"distinct_testable_claim":{"status":"PASS","rationale":"Although selective flow-through purification substantially overlaps prior art, the proposed combination retains a falsifiable distinction: class-resolved spatial loading records from separated media applied to reclaimed solvent immediately before a sensitive synthesis, coupled to measured capture and leaching.","source_ids":["SRC1","SRC3","SRC4"]},"bounded_next_test":{"status":"PASS","rationale":"A pressure-limited aliquot study comparing qualified, reclaimed, and guard-treated solvent with individual benign challenges can measure inlet, interstage, and outlet concentrations, loading response, temperature, pressure drop, leachables, and one approved compatibility assay without production use or scale-up.","source_ids":["SRC3","SRC4"]},"no_obvious_safety_or_authority_stop":{"status":"PASS","rationale":"No blanket stop was found for an approved bench evaluation. Existing purification media and flow-through cartridges support feasibility, while recovered-solvent use remains subject to responsible-chemist, EHS, quality, compatibility, waste, and intended-use controls. Production connection, hazardous challenges, unverified media combinations, and regeneration remain outside the authorized test.","source_ids":["SRC1","SRC3","SRC4"]}},"screen_survival":true,"world_novelty_boundary":"This bounded four-source public-web screen found adjacent prior art but no retained source containing the full proposed combination. It cannot establish world novelty, patentability, market size, expert acceptance, realized value, freedom to operate, or the absence of additional publications, products, patents, or confidential practices."}