Patent No. US11640859 (titled "Data based cancer research and treatment systems and methods") on Oct 17, 2019. The application was issued on May 2, 2023.
’859 is related to the field of genomic sequencing and clinical data management, specifically within the context of cancer research and personalized treatment planning. The invention addresses the technical challenge of integrating disparate, often unstructured data sources—such as raw medical records, next-generation sequencing (NGS) results, and experimental organoid responses—into a unified system that can drive diverse clinical and analytical software applications.
The underlying idea behind ’859 is a multi-tiered data architecture that progressively transforms raw, messy medical information into highly specialized, application-ready formats. Instead of forcing all users to query a single, rigid database, the system utilizes a cascading data-shaping pipeline. This pipeline moves data from a flexible 'lake' for raw storage to a 'vault' optimized for global searching, and finally into 'marts' where the data is restructured specifically to meet the unique interface requirements of different end-user tools, such as physician dashboards or researcher analytics.
The claims of ’859 focus on a method for managing genomic and clinical data through a three-database hierarchy. The process involves capturing original clinical records and NGS data from both cancerous and normal cells, storing them in a semi-structured first database, and then 'shaping' this information into a second database optimized for search. Crucially, the independent claims cover the further step of selecting application-specific subsets of this data and storing them in a third database with a structure specifically optimized for application program interfacing.
In practice, the invention functions as a high-speed translation layer between the lab and the clinic. When a patient’s tumor is sequenced or grown into tissue organoids for drug testing, the resulting efficacy data is ingested alongside historical clinical records. Automated micro-services, such as OCR and natural language processing, work in tandem with human abstractors to normalize this data. This ensures that when a physician opens a treatment planning tool, the system doesn't just provide a list of mutations, but rather a curated, application-specific view that correlates those mutations with proven treatment efficacies and available clinical trials.
This approach differs from prior solutions by decoupling the data storage format from the user interface requirements, allowing for a loosely coupled micro-service architecture. Traditional systems often suffer from performance bottlenecks or rigid schemas that cannot easily adapt to new types of genomic insights. By maintaining three distinct database layers—the data lake, the data vault, and the data marts—the invention allows for rapid system evolution and ensures that complex queries for large-scale research do not interfere with the real-time performance of clinical decision-support tools.
In the late 2010s when ’859 was filed, clinical oncology systems commonly relied on fragmented data silos where genomic sequencing, pathology reports, and longitudinal clinical records were managed as disparate datasets rather than integrated assets. At a time when next-generation sequencing (NGS) was typically implemented using specialized, standalone bioinformatics pipelines, the lack of standardized data normalization made the correlation between specific genetic alterations and long-term treatment efficacy non-trivial. Furthermore, software constraints in medical informatics often forced a trade-off between system speed and data depth, as monolithic architectures made it difficult to rapidly update clinical decision support tools with emerging research insights without extensive manual reprogramming.
The disclosed invention represents a meaningful technical advancement through the implementation of a modular micro-service architecture that enables the rapid integration and normalization of multi-modal healthcare data, including NGS results, clinical records, and organoid treatment efficacy. By compartmentalizing system processes into loosely coupled micro-services that consume and generate defined data products, the architecture overcomes the technical constraint of system rigidity, allowing for the simultaneous development and updating of analytical tools without disrupting the core database. This structural shift is further enhanced by a multi-tier database strategy—comprising a data lake for auditing, a data vault for optimized searching, and data marts for application-specific interfacing—which enables the high-speed delivery of complex genomic-clinical correlations to diverse user types, such as physicians and researchers, through purpose-built interfaces.
This patent contains a total of 83 claims, with claims 1 and 81 serving as the independent claims. The independent claims focus on methods for conducting genomic sequencing and managing cancer patient data through a multi-stage database architecture that integrates clinical records, genomic sequencing data, and organoid treatment efficacy information to optimize data for searching and application-specific interfacing. The dependent claims serve to further specify technical implementations such as the use of micro-service programs and alert lists, identify specific genetic markers and sequencing panels, define various cancer treatment types and immunotherapies, and detail the specific biological sources and formats of the clinical and genomic data processed within the system.
Definitions of key terms used in the patent claims.
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