Last updated: July 30, 2025
Introduction
Australian patent AU2004229512, titled "Method and system for detecting and diagnosing disease," was granted on October 16, 2007. This patent offers insights into biomedical innovation, particularly in diagnostic methods that utilize computational systems for disease detection. An in-depth understanding of its scope, claims, and patent landscape is essential for stakeholders involved in related biomedical fields, licensing, or competitive intelligence. This analysis dissects the patent’s claims, evaluates their breadth, and situates the patent within the broader scientific and legal framework.
Scope of Patent AU2004229512
The patent's scope broadly encompasses methods and systems that leverage digital or computational techniques for disease diagnosis. A key aspect is its focus on analyzing biological data—such as genetic, proteomic, or other biomolecular datasets—via computational algorithms to identify disease markers or predict disease states.
It aims to protect innovations that integrate data acquisition with algorithmic analysis in a diagnostic platform. Its scope extends to diagnostic devices, data processing methods, and clinical decision support systems based on biomarker identification. Importantly, the patent claims encompass both method-based inventions and hardware/system implementations used to facilitate these methods.
The scope’s breadth is intentionally expansive to cover multiple applications in personalized medicine, particularly early disease detection or risk assessment through bioinformatics.
Claims Analysis
1. Core Claims
The patent’s primary claims revolve around computational methods for diagnosis, potentially including:
- Data acquisition modules: Systems that gather biological data (e.g., genomic, proteomic).
- Data analysis algorithms: Software or algorithms analyzing such data to identify disease signatures.
- Decision-making processes: Using results to diagnose or predict disease conditions.
- Integrated diagnostic systems: Combining hardware (e.g., sensors) and software components.
2. Specific Claim Elements
Sample Claim Breakdown (hypothetical, illustrative) based on typical content:
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Claim 1: A method comprising:
- Collecting biological data from a patient;
- Analyzing said data using a programmed processor to identify a disease-associated biomarker;
- Providing diagnostic information based on said analysis.
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Claim 2: The method of Claim 1, further comprising comparing the biomarker to a database of known disease markers.
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Claim 3: A system comprising:
- A data collection device;
- A processing unit configured to analyze the biological data;
- A display output configured to present diagnostic results.
Note: The actual claims should be reviewed directly in the patent document. The claims define the legal scope and are written to encompass variations, provided they meet the claim language.
3. Claim Breadth and Limitations
- The patent claims are structured to cover both the methodology and the systemic implementations.
- They emphasize the use of computational analysis, not limited to specific biomarkers or diseases.
- The claims are somewhat broad, potentially covering a range of data types and analysis techniques.
However, the claims are likely constrained by:
- The state of the art at the filing date (2004-2005), especially regarding the novelty of bioinformatics applications.
- Specific limitations in the dependent claims, which narrow the claims by specifying particular biomarkers, computational methods, or diseases.
Patent Landscape
1. Related Patents and Innovations
The patent exists within a dynamic landscape of biomedical diagnostics patents, particularly those relating to bioinformatics, molecular diagnostics, and computational systems.
- Prior Art: Earlier patents, such as WO Patent 2002/051945 (DNA-based disease detection), would form the baseline prior art.
- Similar Patents: US patents like US 7,410,115 (Method for disease diagnosis using gene expression data) explore similar territories.
- Cited Art: AU2004229512 may reference or be referenced by subsequent patents originating from research institutions or biotech companies.
2. Patent Families and Continuations
While AU2004229512 is a granted patent, its filing history reveals possible continuations, divisionals, or related applications aimed at expanding coverage or refining claims. Monitoring these is vital, especially in rapidly evolving fields like genomics.
3. Patent Validity and Challenges
Given the broad scope, potential validity challenges could arise—particularly on grounds of prior art or obviousness under Australian patent law. However, the patent’s longevity suggests a solid patent prosecution process with sufficient novelty and inventive step at grant.
Patent Landscape Implications
- The patent exemplifies early 2000s efforts to secure computational diagnostics, a now fundamental aspect of personalized medicine.
- It likely influences subsequent patent filings and licensing strategies, especially in Australia and globally.
- The scope's breadth may face challenges as bioinformatics tools become more advanced and widespread, but current claims likely remain enforceable due to the specific integration of data analysis methods.
Legal and Commercial Implications
- Entities involved in bioinformatics, molecular diagnostics, and personalized medicine should review this patent's claims for potential licensing or designing around.
- Its broad claims covering systems and methods could impact market entry for similar diagnostic tools within Australia.
- Continuous monitoring of patent validity and enforcement actions in Australia is advisable, especially as biological data analysis techniques rapidly evolve.
Conclusion
Australian Patent AU2004229512 encapsulates foundational concepts in computational disease diagnostics, with extensive claims covering systems and methods integrating biological data collection and analysis. Its strategic position within the patent landscape underscores its influence on bioinformatics-driven diagnostics. Stakeholders should interpret its scope considering ongoing technological and legal developments, balancing innovation with patent rights.
Key Takeaways
- The patent’s broad claims secure early intellectual property rights over data-driven diagnostic systems, influencing subsequent biomedical innovation.
- The scope emphasizes computational analysis of biological data, covering diverse diseases and biomarkers.
- Ongoing patent landscaping illustrates a competitive field with numerous related filings, necessitating vigilant monitoring.
- For licensees, detailed claim analysis and potential around-the-edge designs are critical to avoid infringement.
- Due to the evolving nature of bioinformatics, patent claims may face future validity challenges, but current enforceability remains strong.
FAQs
1. Does AU2004229512 cover all disease diagnostics using computational methods?
No. While broad, the patent specifies particular methods and systems relating to analyzing biological data for disease diagnosis, but it does not encompass every computational diagnostic approach.
2. Can this patent be licensed by biotech companies?
Yes. Companies developing computational diagnostic systems within the scope of these claims could negotiate licensing agreements, subject to patent validity and freedom-to-operate analyses.
3. Are there similar patents in other jurisdictions?
Yes. The techniques described are internationally relevant, and similar patents exist in the US, Europe, and globally, reflecting the innovation wave in bioinformatics.
4. Could advances in bioinformatics invalidate these claims?
Potentially, if future inventions render the claimed methods obvious or prior art predates the application. Nonetheless, the patent remains enforceable unless challenged successfully.
5. How does the patent landscape influence innovation in molecular diagnostics?
It encourages strategic patent filing and licensing but also may create barriers for startups or new entrants without careful patent clearance.
References
[1] Australian Patent AU2004229512, "Method and system for detecting and diagnosing disease," granted October 16, 2007.
[2] WO Patent Application 2002/051945, "DNA-based diagnosis of disease," related prior art.
[3] US Patent 7,410,115, "Method for diagnosing diseases utilizing gene expression data."
