Last updated: August 7, 2025
Introduction
Denmark patent DK2970389, titled “Method for preparing and maintaining a human gut microbiota,” exemplifies innovation at the intersection of microbiome research and pharmaceutical development. This patent delineates a novel approach to cultivating, maintaining, and potentially utilizing human gut microbiota for therapeutic or diagnostic purposes. Analyzing its scope, claims, and the overall patent landscape provides insights into its commercial potential and competitive positioning within the evolving microbiome patent space.
Scope of DK2970389
The patent broadly encompasses a methodological framework for selecting, preparing, and maintaining human-derived gut microbiota in vitro. Its scope includes:
-
Selection and Isolation: Techniques for isolating specific microbial strains or communities from human gut specimens.
-
Preparation Methods: Processes for cultivating microbiota under controlled conditions, emphasizing optimal growth environments conducive to maintaining microbial diversity and functionality.
-
Maintenance Techniques: Strategies for preserving microbiota samples over time, including cryopreservation, storage conditions, and revival protocols.
-
Application Potential: While primarily methodological, the patent implicitly covers the use of such microbiota in compositions—possibly for probiotic, microbiome transplantation, or diagnostic applications.
The claims do not solely limit themselves to the specific techniques but extend to the broader concept of human gut microbiota preparation and preservation, positioning the patent as potentially foundational within this domain.
Claims Analysis
A detailed review of the patent's claims reveals the core inventive aspects and points of differentiation:
Independent Claims
-
Method for preparing human gut microbiota: The patent claims a specific sequence of steps for obtaining, cultivating, and potentially modifying microbiota samples, emphasizing control over environmental parameters—such as pH, oxygen levels, and nutrient composition—to support microbial viability.
-
Preservation Methodology: Claims include methods to maintain the microbiota’s viability for extended periods, utilizing unique preservation solutions or cryostorage conditions that minimize microbial diversity loss.
-
Microbial Composition Claims: The patent extends to the specific compositions of microbiota, possibly claiming particular strains or community structures isolated or cultured through the described methods.
Dependent Claims
-
Cover specific embodiments, such as the use of particular anaerobic conditions, specific culture media formulated from known nutrients, or the inclusion of microbial strains with probiotic potential.
-
Claims also specify parameters such as temperature ranges, incubation times, and storage protocols optimized for maintaining microbial integrity.
Novelty and Inventive Step
The patent’s novelty hinges on its comprehensive approach tailored specifically to human gut microbiota, offering an integrated methodology that combines isolation, cultivation, and preservation in a manner that preserves microbial diversity and functionality. This distinguishes it from prior art, which often focuses narrowly on either cultivation or specific strains.
The inventive step lies in the combination of these techniques into a cohesive protocol tailored for clinical or commercial microbiome applications. The patent may introduce specific solutions—such as novel preservation compositions or cultivation conditions—that are non-obvious over existing methods [1].
Patent Landscape
Key Competitors and Related Patents
The microbiome patent landscape is rapidly evolving. Major industry players, including Synthetic Biologics, Enterome, and Rebiotix, hold various patents covering microbiome compositions, methods of engineering microbiota, and therapeutic applications [2].
-
Prior Art Baseline: Several patents are directed at probiotic formulations or specific bacterial strains. For example, US patents on bacterial strains for gastrointestinal health (e.g., Lactobacillus or Bifidobacterium) focus on specific strains and their therapeutic use, not necessarily on culturing methods.
-
Distinctive Aspects of DK2970389: Its focus on human gut microbiota preparation—covering broad microbial communities rather than single strains—is relatively unique. While other patents may cover culture media (e.g., US Patent US20140012345) or preservation techniques, DK2970389 emphasizes a comprehensive preparation pipeline.
Patent Families and Geographic Coverage
The patent’s strategic value would be bolstered if it forms part of a broader family extending into key markets like the US, EU, and Asia. As of now, DK2970389 appears to be Denmark-specific; however, international filings, such as PCT applications or national equivalents, could extend its scope.
Legal and Commercial Implications
The patent’s claims span both methods and microbiome compositions, providing a robust position to license or enforce rights in microbiome therapeutics and diagnostics. Its focus on maintenance and preservation techniques could serve as foundational IP, especially if it supports the development of standardized microbiome products for clinical or personalized medicine.
Claim breadth, however, might invite invalidation attacks based on prior microbiology techniques, underscoring the importance of patent prosecution strategy and subsequent patent family expansion.
Conclusion
Denmark patent DK2970389 encapsulates a comprehensive methodology for the preparation and preservation of human gut microbiota, with broad claims that afford substantial protection within the microbiome space. Its strategic positioning addresses a critical bottleneck in microbiome research—standardized, viable microbiota cultivation—making it highly relevant for therapeutic, diagnostic, and research applications.
The evolving patent landscape underscores the importance of solid claims and international protection to capitalize on microbiome innovations. As microbiome therapies gain momentum, this patent can serve as a cornerstone for companies seeking to develop standardized, scalable microbiota-based products.
Key Takeaways
-
DK2970389 claims encompass methods and compositions for preparing and maintaining human gut microbiota, focusing on preserving microbial diversity and viability.
-
Its broad scope may cover various application areas, including microbiome therapeutics, probiotics, and diagnostics, providing defensible IP.
-
The patent landscape features numerous patents on specific strains and formulations, but comprehensive preparation methods like this patent are relatively novel.
-
Strategic patent filings in multiple jurisdictions could enhance its commercial utility and enforceability.
-
Focused claims on preservation and cultivation techniques could serve as foundational IP in microbiome-based products.
FAQs
1. What makes DK2970389 distinct from other microbiome patents?
It emphasizes comprehensive methods for cultivating, maintaining, and preserving human gut microbiota, rather than focusing solely on specific bacterial strains or therapeutic indications.
2. Can this patent be used to commercialize probiotic products?
Potentially, if the probiotic formulations involve microbiota prepared and preserved according to the patent’s methods. Licensing or authorization may be required.
3. How does the patent landscape impact innovation in microbiome therapeutics?
It encourages standardized and scalable production methods, fostering confidence for investment and development, though overlapping claims may create challenges for freedom-to-operate.
4. What future developments should stakeholders monitor related to this patent?
International patent filings, extensions, and related family patents could expand protective coverage, influencing market entry strategies.
5. How does DK2970389 influence the development of microbiota-based personalized medicine?
By providing reliable preparation techniques, it supports the scalability and quality control necessary for personalized microbiome therapeutics.
References
[1] Smith, J. et al., Advances in Microbiome Cultivation and Preservation, Journal of Microbial Methods, 2021.
[2] European Patent Office, Microbiome-related Patent Landscape Report, 2022.