Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,233,118
Introduction
U.S. Patent 9,233,118, titled "Method and System for Personalized Disease Management," was granted on January 5, 2016. This patent, assigned to a major pharmaceutical and healthcare innovation entity, encompasses novel methodologies and systems for individualized disease intervention, leveraging computational and data-driven approaches. Its scope and claims hold significant implications for personalized medicine, pharmaceutical development, and digital health landscapes. Analyzing its intricacies reveals the boundaries of its patent protection and its positioning within the broader patent landscape.
Scope of U.S. Patent 9,233,118
The patent primarily covers a comprehensive framework combining data analytics, patient-specific diagnostics, and tailored therapeutic strategies. It extends to both method claims—outlining procedures for managing disease at an individual level—and system claims that detail architectural components facilitating such personalized health interventions.
The core scope encompasses:
- Data Collection & Processing: Employing patient health records, biomarker data, genomic sequences, and other personalized data streams.
- Analytical Algorithms: Utilizing computational models—such as machine learning—to predict disease progression, treatment responses, and optimize therapeutic regimens.
- Personalized Treatment Systems: Implementing hardware or software platforms that deliver individualized therapeutic suggestions or interventions.
- Feedback and Adjustment Mechanisms: Continuous monitoring and refinements based on evolving patient data to adapt therapy dynamically.
This broad scope underpins a system and method for integrating diverse data sources and advanced analytics to achieve personalized disease management.
Claims Analysis
A thorough review of the patent’s claims indicates a layered structure, balancing broad functional claims with more specific implementations.
Independent Claims
The key independent claims focus on:
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A method for managing a patient's disease state, comprising:
- Gathering patient-specific data (genomic, phenotypic, historical treatment data).
- Processing data through a predictive model to assess disease status or treatment response.
- Generating personalized recommendations or adjustments to therapy based on model outputs.
- Delivering these recommendations through a digital interface or system.
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A system comprising:
- Data acquisition modules for collating patient data.
- Computational modules executing predictive analytics.
- User interfaces providing tailored treatment guidance.
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A computer-readable medium storing instructions to execute the above method.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Use of specific machine learning algorithms (e.g., neural networks, decision trees).
- Incorporation of specific biomarker measurements.
- Application to particular diseases, notably cancer, metabolic disorders, or infectious diseases.
- Integration with electronic health records (EHR) systems or remote monitoring devices.
Claim Interpretation
The claims’ language suggests a focus on:
- Innovative integration of multi-modal patient data.
- Use of advanced analytics for real-time or near-real-time decision-making.
- Personalization as a function of both data input and machine learning outputs.
The claims are primarily directed towards a transformative approach within healthcare IT, emphasizing dynamic, data-driven treatment planning.
Patent Landscape Analysis
The patent landscape surrounding U.S. Patent 9,233,118 spans several key domains:
1. Competitor Portfolios and Related Patents
Major pharmaceutical and technology firms have filed numerous patents addressing personalized medicine, diagnostics, and health informatics. Notably:
- IBM Watson Health: Patents covering AI-driven clinical decision support systems.
- Guardant Health: Diagnostics-driven patents for tumor profiling and treatment stratification.
- Tempus Labs: Patents for integrating clinical and molecular data for precision oncology.
Compared to these, Patent 9,233,118 emphasizes the systemic and methodical integration of predictive analytics with individualized treatment recommendations, aligning with industry trends toward digital therapeutics.
2. Patent Classifications and Trends
Key classifications include:
- G16H (ICT in health care): Digital health record and decision support systems.
- A61B (Diagnosis, surgery, identification): Diagnostic and monitoring devices.
- G06N (Computer systems based on specific computational models): Machine learning applications.
The trend indicates increasing patent filings under G16H, reflecting growing investments in health informatics and AI for patient-specific management.
3. Patentability and Freedom-to-Operate
Given the widespread activity in digital health and personalized medicine, patentability necessitates demonstrating inventive step over prior art—such as earlier digital diagnostic methods, prior machine learning applications in healthcare, or personalized treatment patent applications.
- The claims' emphasis on specific integrations and particular algorithms can impose limitations, potentially avoiding prior art.
- However, the broad functional scope could be challenged, emphasizing the importance for patent owners to delineate innovative features clearly.
4. Litigation and Licensing Landscape
The patent landscape is increasingly litigious, with influential patent trolls and industry litigants asserting claims related to digital health systems and biometric data processing. Patent 9,233,118’s claims could attract enforcement or licensing considerations, especially if similar systems are commercialized.
Strategic Implications for Stakeholders
- Pharmaceutical companies should evaluate how this patent intersects with their research on personalized therapies, ensuring freedom to operate or seeking licensing opportunities.
- Technology developers can leverage the patent’s claims as a reference for designing compliant systems, especially for AI-driven decision tools.
- Patent filers aiming at competing or complementary innovations must consider designing around its scope or challenging its validity to avoid infringement.
Conclusion
U.S. Patent 9,233,118 defines a significant step forward in healthcare personalization, emphasizing advanced data analytics and modular systems for tailored disease management. Its broad claims, centered on integrating multi-modal data with predictive algorithms, position it within the core patent landscape of digital health and precision medicine. Navigating its scope requires awareness of existing patents and ongoing innovations within the rapidly evolving digital health ecosystem.
Key Takeaways
- The patent’s scope encapsulates integrated data collection, predictive analytics, and personalized system outputs, positioning it as foundational in digital personalized medicine.
- Its claims focus on methods, systems, and software embodied in a platform enabling dynamic, tailored treatment recommendations.
- The patent landscape features strong activity around AI, diagnostics, and health informatics, with legal and strategic importance for stakeholders to assess infringement risks.
- Innovation often centers on specific algorithms, data sources, and disease applications; broad claims necessitate careful mapping to avoid conflicts.
- Entities wishing to develop competing systems should evaluate licensing, design-around options, and the patent’s validity to mitigate infringement risks.
FAQs
1. What is the primary innovation claimed in U.S. Patent 9,233,118?
It claims a comprehensive system and method for integrating patient-specific data with predictive analytics to generate personalized disease management recommendations, emphasizing dynamic and individualized treatment adjustments via digital platforms.
2. Which diseases or medical conditions does the patent target?
While broadly applicable, the patent specifically emphasizes applications in chronic and complex diseases such as cancer, metabolic disorders, and infectious diseases, where personalized treatment strategies benefit from multi-modal data integration.
3. How does this patent impact competitors developing digital health solutions?
It potentially restricts the development of similar integrated predictive analytics platforms if they fall within the scope of its claims, particularly those that combine multi-source data processing with personalized treatment suggestions.
4. Can the patent’s broad claims be challenged or countered?
Yes. Challenges can be based on prior art demonstrating similar data processing systems or methods, or on arguments that the claims lack inventive step or are indefinite. Patent validity assessments are essential for potential infringers.
5. What strategic moves should companies consider regarding this patent?
Companies should perform freedom-to-operate analyses, consider licensing agreements, or develop design-around innovations that avoid the patent’s core claims, ensuring their products do not infringe while maintaining innovation.
References
- U.S. Patent No. 9,233,118, "Method and System for Personalized Disease Management," issued January 5, 2016.
- U.S. Patent Classification Data – for classifications G16H, G06N, and A61B.
- Industry reports on digital health patent activity, e.g., Watson Health Patents.
- Recent patent filings and litigations in personalized medicine and health informatics (sector-specific patent analytics reports).
