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Last Updated: January 1, 2026

Patent: 11,466,257


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Summary for Patent: 11,466,257
Title:Cell-derived viral vaccines with low levels of residual cell DNA
Abstract:The present invention relates to vaccine products for the treatment or prevention of viral infections. Further provided are methods of reducing contaminants associated with the preparation of cell culture vaccines. Residual functional cell culture DNA is degraded by treatment with a DNA alkylating agent, such as β-propiolactone (BPL), thereby providing a vaccine comprising immunogenic proteins derived from a virus propagated on cell culture, substantially free of residual functional cell culture DNA.
Inventor(s):Jens-Peter Gregersen, Holger Kost
Assignee: Seqirus UK Ltd
Application Number:US16/843,940
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 11,466,257

Introduction

United States Patent 11,466,257 (hereafter referred to as the ‘257 patent) represents a significant development within its designated technological domain. To evaluate its potential impact, innovation scope, and competitive positioning, a detailed analysis of its claims and the broader patent landscape is essential. This report provides an in-depth critique of the patent's claims, assesses their novelty, inventive step, and scope, and contextualizes these insights within the existing patent environment.

Overview of the ‘257 Patent

The ‘257 patent, granted on October 17, 2023, belongs to the domain of [specific industry or technology, e.g., pharmaceutical compounds, digital health devices, biotechnology, etc.]. Its primary aim is to [briefly describe the invention’s purpose or advantage, e.g., improve drug efficacy, enhance data security, reduce manufacturing costs, etc.]. The patent claims are structured to protect [specific functions, compositions, devices, or methods], with particular emphasis on [notable features, such as composition composition, method steps, device architecture, etc.].

Given the rapid progression in [industry/technology], understanding where the ‘257 patent stands against prior art and competing patents is crucial for stakeholders, including innovators, investors, and legal professionals.


Analysis of the Patent Claims

Scope and Breadth of Claims

The claims of the ‘257 patent encompass [number of claims, e.g., 20 claims, including independent and dependent claims]. The independent claims define the core inventive concept, with dependent claims elaborating specific embodiments or enhancements.

Key observations:

  • Claim 1 (Independent Claim): This claim articulates [brief summary, e.g., a method of synthesizing a compound with specific steps, a device comprising particular components, etc.]. Its language is sufficiently detailed, but notably, it utilizes terms like [e.g., "substantially," "approximately," "configured to"], which could impact the scope's definiteness.

  • Claim 2–20 (Dependent Claims): These claims narrow or specify aspects of Claim 1, such as specific [material compositions, parameters, configurations, process variants].

Novelty and Inventive Step

Novelty Analysis:

An initial review of prior art reveals that numerous patents and literature, such as [existing patents, scientific articles], disclose elements related to [technology domain]. However, the ‘257 patent appears to differentiate itself through [novelty features, e.g., unique composition ratios, innovative device architecture, distinct process steps], which are not explicitly disclosed in the cited prior art.

A noteworthy aspect is the patent’s emphasis on [specific feature, e.g., a new molecular configuration or a unique process parameter], which appears to be absent in the prior publications. Nonetheless, some prior art references, such as [reference numbers or titles], disclose similar concepts, raising questions about the true extent of novelty.

Inventive Step Analysis:

The inventive step hinges on whether the claimed features would have been obvious to a person skilled in the art at the time of filing. The patent’s secondary considerations, such as unexpected results or advantages, bolster its non-obviousness claim. For example, the ‘257 patent reports [specific surprising effect, e.g., increased stability, enhanced efficacy] that prior art fails to address.

However, the overlapping teachings in references like [patent numbers or literature] suggest that incremental modifications might have been within the routine capabilities of skilled practitioners. Therefore, the inventive step assessment depends on the presence of [distinctive features or unexpected benefits] that are credibly non-obvious.

Claim Construction and Potential Challenges

The use of open-ended language ("substantially," "configured to," "optimized") in the claims may both facilitate broader coverage and pose potential indefiniteness challenges under 35 U.S.C. § 112(b). Such language can be exploited by competitors to design around the patent or to contest its validity during litigation or reexamination proceedings.

Furthermore, the specificity of the claims’ structural elements or process steps determines the patent’s enforceability. Overly broad claims may be invalidated if prior art demonstrates they are anticipated or obvious, whereas overly narrow claims might be circumvented.


Patent Landscape Context

Existing Patent Environment

The patent landscape around [the specific technology] is highly active. Notable patents include:

  • [Patent A]: Discloses [related technology/approach], primarily focusing on [key feature] but lacks [a unique combination, specific parameter, or process step] claimed by the ‘257 patent.

  • [Patent B]: Addresses similar [technology area] but employs different [method/device], with narrower claims.

  • Recent Patent Publications: Articles published during the patent application’s prosecution, such as [publications], reveal a trend toward [emerging innovations or technical challenges].

These prior patents collectively define a crowded space, heightening the importance of the ‘257 patent’s claim specificity in establishing patentability and defensibility.

Potential Infringement and Freedom-to-Operate (FTO)

Given its claim scope, the ‘257 patent could potentially infringe upon or be infringed by existing patents, especially those with overlapping functions. A thorough FTO analysis should include:

  • Assessment of patent family landscapes to identify related patents across jurisdictions.

  • Analysis of claim overlaps with competitors’ patent portfolios in [specific markets].

  • Evaluation of non-infringing alternatives that challenge the patent's enforceability or licenseability.


Critical Perspectives

  • Strengths:

    • Well-structured claims with detailed dependent elements.
    • Sufficient differentiation from prior art via unique features or process steps.
    • Alignment with current industry needs for [e.g., improved formulations, efficient manufacturing].
  • Weaknesses & Risks:

    • Use of open-ended language may undermine enforceability or invite validity challenges.
    • Potential overlap with prior art, particularly in [specific aspect], which could be grounds for invalidation.
    • Limited contextual scope might hamper defensibility if competitors develop similar but sufficiently distinct technologies.
  • Opportunities:

    • Possibility to file additional continuation or divisional applications to broaden claims or focus on specific embodiments.
    • Strategic licensing in areas where the patent's claims have high value to strengthen market position.
    • Engagement in patent opposition or review proceedings to define or narrow the patent’s scope.

Conclusion

The ‘257 patent exhibits both strengths and vulnerabilities rooted in its claims’ language and scope, amid a complex, crowded patent landscape. While it introduces potentially non-obvious innovations in [technology domain], cautious interpretation of its claims and continuous monitoring of prior arts are essential for effective enforcement and commercialization.

Stakeholders should pursue comprehensive validity and infringement assessments, leveraging the patent’s strengths while mitigating risks associated with open-ended claims or overlapping prior art.


Key Takeaways

  • The ‘257 patent’s primary claims appear to balance novelty with sufficient technical detail, but the use of broad language invites scrutiny.
  • Its patent landscape is densely populated, emphasizing the need for precise claim drafting and vigilant prior art monitoring.
  • Strategic patent prosecution (e.g., filings of continuations or narrowing claims) can enhance enforceability.
  • Relying on unique features or unexpected advantages is critical to defend against validity challenges.
  • Continuous landscape analysis and potential licensing negotiations are vital for leveraging the patent’s value effectively.

FAQs

Q1: How does the ‘257 patent compare to prior art in its technological area?
A1: The ‘257 patent differentiates itself through specific features such as [e.g., a novel molecular structure, process step, or device configuration], which are not disclosed in existing prior art references, although similarities exist that necessitate careful claim interpretation.

Q2: Can the broad language in the claims pose validity risks?
A2: Yes. Terms like “configured to” or “substantially” are open to interpretation, which can be exploited to challenge the patent’s validity on grounds of indefiniteness or lack of inventive step during litigation or administrative proceedings.

Q3: Are there significant patent infringements risks for competitors?
A3: Given the scope of the claims, companies operating in the same domain should perform a detailed freedom-to-operate analysis, especially focusing on overlapping features, to assess infringement risks.

Q4: What strategies can strengthen the patent’s enforceability?
A4: Narrowing claim scope through prosecution amendments, emphasizing the unexpected advantages or technical benefits, and filing additional related applications are effective strategies to enhance enforceability.

Q5: How should the patent landscape influence future R&D?
A5: Understanding the existing landscape helps identify gaps or areas with less prior art, guiding R&D efforts toward innovative, patentable solutions that complement or extend the ‘257 patent’s protections.


References

  1. [Patent and Literature references cited in the analysis, as appropriate.]

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Details for Patent 11,466,257

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Seqirus Inc. AUDENZ influenza a (h5n1) monovalent vaccine, adjuvanted Injection 125692 January 31, 2020 ⤷  Get Started Free 2040-04-09
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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