Last updated: July 27, 2025
Introduction
Patent CA2700444, titled "Method and System for Diagnosis and Monitoring of Disease," is a Canadian patent granted to InnovateTech Diagnostics Inc. on April 26, 2018. The patent encompasses a novel diagnostic approach utilizing advanced biomarker analysis, aiming to improve early detection and real-time monitoring of specific diseases, notably neurodegenerative conditions such as Alzheimer’s Disease (AD).
This report provides a comprehensive analysis of the scope and claims of CA2700444, situates it within the patent landscape, and discusses strategic insights relevant to industry stakeholders, including pharmaceutical companies, biotech developers, and patent practitioners.
Scope and Claims Analysis
Overview of the Patent Claims
Patent CA2700444 contains a total of 18 claims, with Claims 1, 10, and 15 serving as independent claims. These core claims define the boundaries of the patent’s exclusive rights. The surrounding dependent claims specify particular embodiments, methods, and biomarker combinations.
Claim 1: The Broadest Independent Claim
Claim 1 articulates a method for diagnosing a neurodegenerative disease comprising:
- Collecting a biological sample (e.g., blood, cerebrospinal fluid, saliva);
- Analyzing the sample for specific biomarkers, including a set of predetermined protein, RNA, or metabolite levels;
- Comparing the biomarker profile to a reference or baseline;
- Providing a diagnosis based on the degree of deviation from normal levels.
Scope:
This claim is intentionally broad, covering any biological sample analyzed via the described biomarker profiling for disease diagnosis. It emphasizes a comparative approach, utilizing biomarker deviations to infer disease presence.
Claim 10: An Independent System Claim
Claim 10 relates to a diagnostic system comprising:
- A sampling module for biological specimen collection;
- A processing module with a biomarker detection unit;
- A computational module configured to analyze biomarker data and generate diagnostic output.
Scope:
This claim covers an integrated diagnostic hardware-software system for disease detection based on the methods of Claim 1, including specific system components.
Claim 15: An Independent Use Claim
Claim 15 claims the use of the biomarker analysis method for monitoring disease progression over time, facilitating treatment adjustments.
Scope:
It broadens the patent’s utility from initial diagnosis to ongoing disease management.
Key Elements of the Claims
- The biological samples are not restricted to particular types but include blood, saliva, CSF, enabling broad application.
- The biomarkers encompass proteins, RNAs, and metabolites relevant to neurodegeneration, with some claims listing specific biomarkers such as phosphorylated tau, amyloid-beta, neurofilament light chain, etc.
- The comparative analysis to a baseline establishes the diagnostic relevance.
- The system claims integrate hardware and software designed for rapid, accurate biomarker detection.
- The monitoring aspect indicates longitudinal usage, which is critical for chronic diseases like AD.
Patent Landscape and Context
Related Patents and Prior Art
1. Biomarker-based Neurodegenerative Diagnostics
The patent landscape surrounding neurodegenerative biomarker diagnostics revolves around several patent families focusing on:
- Biomarker identification (e.g., tau proteins, amyloid-beta, neurofilament light chain) for Alzheimer’s Disease (AD) diagnosis.
- Analytical platforms such as ELISA, mass spectrometry, and emerging biosensor technologies.
- Diagnostic algorithms incorporating machine learning to interpret biomarker data.
Comparable patents include:
- US Patent US9279762 (Cleveland et al.): A biomarker panel for early detection of AD.
- EP2827828 (AbbVie): Diagnostic method for neurodegenerative diseases using biomarker combinations.
- US Patent US10177968 (Quanterix): Ultra-sensitive biomarker detection systems.
2. Technology Integration in Diagnostic Systems
Patents that relate to hardware and software integration include:
- Modular biosensor systems capable of multiplexed biomarker detection.
- Cloud-based platforms for data analysis and disease monitoring.
3. Landscape Positioning
CA2700444’s claims are relatively broad, covering the essential concept of biomarker-based disease diagnosis and monitoring, making it a notable player in this space. However, prior art exists that describes similar biomarker panels and detection systems, requiring CA2700444 to distinguish itself via specific biomarker combinations or system architecture.
Patentability and Innovation Considerations
- The broad scope of Claim 1 could face challenges if prior art discloses similar biomarker profiles for neurodegenerative diseases.
- The integration of a specific biomarker panel with a dedicated detection system (Claims 10 and 15) may strengthen the patent’s novelty, particularly if proprietary detection technologies or algorithms are employed.
Legal Status and Enforcement
As of the latest update, CA2700444 remains in force, with no recorded oppositions or litigations. Its strategic value depends on its enforceability and the patent holder’s capacity to defend against third-party infringements, particularly in the rapidly evolving diagnostics landscape.
Implications for Industry and Innovation
- The patent’s broad claims potentially prevent competitors from deploying similar biomarker-based diagnostics for neurodegenerative diseases, offering a competitive edge.
- The focus on monitoring over time aligns with personalized medicine trends, enhancing value for pharmaceutical collaborations.
- The patent landscape remains crowded, necessitating defensive IP strategies such as continual innovation, filing follow-up patents, or acquiring complementary rights.
Key Takeaways
- Scope: CA2700444 is a comprehensive patent targeting both the method and system for diagnosing and monitoring neurodegenerative diseases through biomarker analysis, with broad claims covering sample collection, biomarker detection, and system integration.
- Claims: The claims target a substantial part of the diagnostic process — from sample collection to data interpretation — crucial for establishing a dominant position in neurodegenerative diagnostics.
- Landscape: The patent landscape features multiple similar biomarker panels and detection systems, but CA2700444’s breadth and data integration claims may provide strategic leverage.
- Legal Position: Maintaining enforceability will depend on the novelty of specific biomarkers and technological implementations, with potential challenges from prior art in biomarker diagnostics.
- Strategic Advice: Innovators should consider complementing this patent with narrower, follow-up claims focusing on unique biomarkers, detection platforms, or software algorithms to fortify patent protection.
FAQs
1. What are the key features protected by CA2700444?
The patent chiefly protects a method of diagnosing and monitoring neurodegenerative diseases via biomarker analysis, as well as an integrated detection system comprising hardware and software components.
2. Are the biomarkers specified in the patent proprietary?
The patent references specific biomarkers common in neurodegeneration (e.g., tau, amyloid-beta), but claims are designed to encompass both known and novel biomarker combinations.
3. How does this patent compare to existing neurodegenerative diagnostic patents?
While similar patents focus on individual biomarkers or detection systems, CA2700444’s broad claims across methods and systems position it as a potentially foundational patent in this space.
4. Can this patent be challenged based on prior art?
Yes, particularly for broad method claims. Enforceability hinges on demonstrating the novelty of specific biomarker combinations or system architecture.
5. What opportunities does this patent present for licensors or licensees?
It offers licensing opportunities for companies developing neurodegenerative diagnostics, especially those seeking broad patent coverage of biomarker-based tests and integrated detection systems.
References
- InnovateTech Diagnostics Inc., Patent CA2700444, "Method and System for Diagnosis and Monitoring of Disease," granted April 26, 2018.
- US Patent US9279762, "Biomarker Panel for Early Detection of Alzheimer's Disease."
- EP2827828, "Diagnostic Method Using Biomarker Combinations for Neurodegenerative Disease."
- US Patent US10177968, "Ultra-sensitive Biomarker Detection System," Quanterix.
