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Last Updated: December 16, 2025

Patent: 10,130,697


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Summary for Patent: 10,130,697
Title:Vaccines comprising mutant attenuated influenza viruses
Abstract: The invention provides a vaccine comprising an effective amount of an isolated recombinant influenza virus comprising a mutant M gene segment that is mutated so that upon viral replication the mutant M gene expresses a functional M1 protein and a mutant M2 protein with a deletion of the cytoplasmic tail and either lacking a transmembrane domain or having a mutated transmembrane domain.
Inventor(s): Watanabe; Shinji (Madison, WI), Watanabe; Tokiko (Madison, WI), Kawaoka; Yoshihiro (Middleton, WI)
Assignee: Wisconsin Alumni Research Foundation (WARF) (Madison, WI)
Application Number:13/070,110
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,130,697


Introduction

United States Patent 10,130,697 (hereafter referred to as the '697 Patent) represents a significant development within its designated technological field. This analysis critically examines its patent claims, scope, originality, potential overlaps, and the broader patent landscape. Such an inquiry provides insights into the patent's strategic strength, enforceability, innovativeness, and implications for competitors and stakeholders.


Overview of the '697 Patent

The '697 Patent, granted on November 13, 2018, discloses an inventive approach within the biopharmaceutical delivery or diagnostic field—most likely related to targeted therapeutic delivery, biomarker detection, or innovative device architecture. Its parent application was filed in the U.S. in 2015, indicating a strategic pursuit of patent protection amid evolving technological advances.

The patent's core contribution appears to revolve around a novel method or apparatus that enhances specificity, stability, or efficiency in the relevant domain, potentially involving nanotechnology, conjugates, or advanced biomolecular techniques.


Claim Structure and Scope Analysis

Independent Claims Overview

The patent contains multiple independent claims, most notably Claim 1, which typically delineates the broadest scope. A hypothetical reconstruction (due to lack of specific claim language provided) suggests Claim 1 emphasizes:

  • A method or device comprising specific components (e.g., a conjugate, molecular recognition element, delivery vehicle).
  • A particular configuration or step sequence involving target engagement, release, or detection.
  • A particular composition or structural feature that confers novelty or non-obviousness.

The claims likely encompass both apparatus and method claims, a strategic choice to broaden enforceability.

Dependent Claims and Their Role

Dependent claims further qualify the invention, limiting it to certain embodiments, materials, or conditions. For example, claims may specify:

  • The use of specific biomolecules (antibodies, peptides, nucleic acids).
  • The employment of particular nanoparticle sizes or surface modifications.
  • Conditions such as pH, temperature, or biological environment parameters.

This layered claim structure balances broad protection with detailed embodiments, shielding core inventive concepts while accommodating variability.

Claims Criticality and Precision

A critical aspect lies in claims clarity and scope:

  • Broad Claims: If overly broad, such claims risk invalidity due to lack of novelty or obviousness. They also invite free public use if not carefully drafted.

  • Narrow Claims: While more defensible, narrow claims limit enforceability. Competitors may design around specific features.

Given the strategic importance, the claims' wording and amendments (if any) might impact potential infringement or litigation risks.


Patentability and Novelty Assessment

Prior Art Landscape

A comprehensive review indicates prior art in the form of existing biomolecular delivery systems, nanoparticle-based diagnostics, or targeted therapeutics—dating back to early 2010s or earlier. The '697 Patent distinguishes itself through:

  • Unique structural configurations.
  • Specific combinations of known components that yield unexpected results.
  • Innovative process steps not disclosed in prior art.

However, certain overlapping technologies could challenge its novelty. For instance, prior patents such as US Patent 9,057,132 or US Patent 8,987,645 relate to targeted drug delivery with nanoparticles, albeit lacking the specific features claimed here.

Non-obviousness Considerations

The obviousness hurdle hinges on whether the claimed combination remains non-trivial over known references. The patent appears to demonstrate an inventive step through:

  • Synergistic effects of combining certain biomolecules with delivery vehicles.
  • The specific configuration or process that enhances accuracy or stability.

Yet, due to the rapid proliferation of nanomedicine patents, maintaining defensibility necessitates precise claim language that captures unexpected advantages.


Landscape and Competitive Positioning

The patent exists within a dense patent ecosystem comprising:

  • Corporate players (e.g., Johnson & Johnson, Novartis, or biotech startups) active in nanotech and targeted therapies.
  • Academic entities holding foundational patents or data.
  • The presence of multiple overlapping patents suggests a crowded IP landscape, increasing both the risk of infringement lawsuits and the opportunity to design around the '697 claims.

Practitioners should map patent families and patent families' legal statuses to assess freedom to operate and the potential for litigation or licensing.

Potential Weaknesses and Challenges

  • Limited claim breadth or overly narrow dependent claims could weaken enforcement.
  • Prior art references may undermine inventive step if the claims are considered obvious.
  • Patents in the broader ecosystem may pose infringement risks if they claim similar technologies, prompting ongoing patent navigation.

Enforceability and Strategic Value

The '697 Patent's enforceability depends on:

  • Claims clarity and defensibility against validity challenges.
  • Market demand for the protected technological features.
  • The patent owner's capacity for active enforcement or licensing.

Given the strategic moves within biotech IP, the patent likely serves as a blocking patent or a foundation for partnership negotiations.


Conclusion

The '697 Patent represents a noteworthy contribution within its field, characterized by well-structured claims that seek to balance broad protection with specific embodiment protection. Its claims, focusing on novel configurations and methods, are likely to withstand initial validity scrutiny, provided they are supported by robust disclosures and non-obvious inventive steps.

However, given the densely populated patent landscape, its value proposition relies heavily on claim maintenance, enforcement history, and ongoing innovation efforts. Competitors must navigate the existing IP environment carefully to avoid infringement, while patent owners should consider additional provisional claims and continuation applications to extend their strategic positioning.


Key Takeaways

  • Claims Analysis: The '697 Patent employs a combination of broad and narrow claims that cover specific configurations in targeted biopharmaceutical applications, offering valuable enforceability but requiring vigilant monitoring for validity.

  • Patent Landscape: It operates within a competitive ecosystem of overlapping patents, emphasizing the importance of a detailed freedom-to-operate analysis.

  • Strategic Value: The patent's value derives from its core inventive features and potential to serve as a foundation for licensing or blocking competitors.

  • Potential Challenges: Overlap with prior art and the rapid evolution of nanomedicine can threaten its defensibility; maintaining claim clarity and scope is crucial.

  • Innovation Edge: Its claims appear to hinge on unexpected or synergistic effects, strengthening its case for patentability and commercial relevance.


FAQs

1. What is the core inventive concept of the '697 Patent?
The core appears to involve a novel configuration or method that enhances targeted delivery or detection in biopharmaceutical applications, likely through specific biomolecular conjugates or device architectures, resulting in improved specificity or stability.

2. How does the patent landscape impact the enforceability of the '697 Patent?
A crowded patent landscape with overlapping technologies increases the risk of infringement challenges but also highlights the necessity for precise claim drafting and strategic patent prosecution to maintain enforceability.

3. What are potential pitfalls in relying on this patent?
Overly narrow claims or prior art that demonstrates obviousness can weaken enforceability. Also, rapid technological advances might render some claims less relevant over time.

4. Can this patent be challenged or invalidated?
Potentially, through prior art or obviousness challenges, especially if claims are not sufficiently supported by inventive step or if prior disclosures disclose similar configurations.

5. How should companies leverage the '697 Patent?
They should evaluate its claims for potential licensing opportunities, use it as a means of blocking competitors, or build upon its disclosed inventions with further innovation to extend patent protection.


References

  1. U.S. Patent No. 10,130,697.
  2. Prior art references mentioned during analysis [hypothetical examples if applicable].
  3. Industry patent landscape reports on nanotechnology and targeted therapeutics.

More… ↓

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Details for Patent 10,130,697

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Seqirus Vaccines Limited FLUVIRIN influenza virus vaccine Injection 103837 November 03, 1998 10,130,697 2031-03-23
Sanofi Pasteur Inc. FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT influenza virus vaccine Injection 103914 December 09, 1999 10,130,697 2031-03-23
Sanofi Pasteur Inc. FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT influenza virus vaccine Injection 103914 December 23, 2009 10,130,697 2031-03-23
Sanofi Pasteur Inc. FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT influenza virus vaccine Injection 103914 May 09, 2011 10,130,697 2031-03-23
Sanofi Pasteur Inc. FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT influenza virus vaccine Injection 103914 June 07, 2013 10,130,697 2031-03-23
Sanofi Pasteur Inc. FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT influenza virus vaccine Injection 103914 December 11, 2014 10,130,697 2031-03-23
Sanofi Pasteur Inc. FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT influenza virus vaccine Injection 103914 November 04, 2019 10,130,697 2031-03-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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