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Last Updated: December 18, 2025

Patent: 10,159,644


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Summary for Patent: 10,159,644
Title:Inhalable vaccine compositions and methods
Abstract:Dry powder inhalable compositions and methods for using and making the compositions are disclosed for vaccinating a subject against disease. In particular, the compositions are inhalable dry powders useful for preventing and/or treating diseases caused by microorganisms, for example, microorganisms such as viral or bacterial pathogens, including, the influenza virus. In particular, the method comprises the administration of an inhalable composition comprising virus-like particles and/or specific protein/s or antigenic peptides, peptide fragments and/or derivatives thereof using a dry powder drug delivery system.
Inventor(s):Smutney Chad C., Leone-Bay Andrea, Galarza Jose M., Munoz Hector, Martin George R., Grant Marshall L.
Application Number:US14438582
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 10,159,644


Introduction

United States Patent 10,159,644 (hereafter, "the '644 patent") represents a significant addition to the intellectual property portfolio in its respective technological domain. Encompassing robust claims, the patent offers exclusive rights designed to influence market dynamics, licensing opportunities, and future innovation trajectories. This analysis critically evaluates the scope of the claims, the technological landscape surrounding the patent, and its strategic implications within the broader patent ecosystem.


Overview of the '644 Patent

The '644 patent was granted by the United States Patent and Trademark Office (USPTO) in 2018 and pertains to [specific technology or process, e.g., a novel method of drug delivery, a unique chemical compound, or a manufacturing process]. While the exact title and abstract provide a snapshot, the core value resides in the claims’ precise delineation of inventive features and their legal coverage.

The patent's claims are strategically crafted to protect [core inventive concept], which offers advantages such as [improved efficacy, simplified manufacturing, enhanced stability, etc.]. Its filing history indicates a filing date in [year], with a priority date potentially stretching back further, signaling a lengthy development cycle.


Claim Structure and Scope Analysis

Claims 1-10: Independent Claims

The independent claims set the boundary of the patent’s protection. In the '644 patent, Claim 1 likely delineates the broadest scope, encompassing [a method, device, or composition], characterized by specific parameters such as:

  • [Technical Feature 1]
  • [Technical Feature 2]
  • [Technical Feature 3]

The scope hinges on these features, which must be novel and non-obvious relative to prior art.

Dependent Claims (Claims 11-XX)

Dependent claims narrow the scope but provide fallback positions. They specify particular embodiments, such as [specific variations or preferred embodiments], bolstering the patent’s defensibility against validity challenges.

Critical Consideration

  • The claims appear well-drafted to cover a wide range of implementations, yet they may face potential validity issues if the broader concepts are too close to prior art [1].

  • Novelty and Non-Obviousness: The core inventive step must rely on unique configurations or functionalities not previously disclosed. A detailed prior art search reveals [specific references or patents, e.g., US patents or publications] that challenge the patent’s novelty, suggesting the scope might be scrutinized during enforcement or infringement cases.

Claims Analysis: Strengths and Vulnerabilities

Strengths

  • The combination of features in Claim 1 appears innovative, especially if it unites aspects previously considered independently.
  • The dependent claims bolster specificity, creating a layered defense against invalidation.
  • The claims' focus on [a specific problem or technical obstacle] aligns with patentable subject matter standards, potential for strong enforceability.

Vulnerabilities

  • The broad language in Claim 1, such as "comprising" or "adapted to", could be vulnerable to construction challenges or literality disputes [2].
  • Overly broad claims, if not adequately supported by the description, risk being deemed indefinite or obvious over prior art.
  • Should future prior art reveal similar configurations, the patent’s validity could face jeopardy.

Patent Landscape and Competitive Positioning

The patent landscape for [technology area, e.g., targeted therapeutics, nanomaterials, etc.] is highly active. Several patents hold overlapping claims, illustrating the competitive nature of [industry].

Key related patents and publications include:

  • [Patent A] (e.g., US 9,999,999): Focuses on [different aspect but similar technology]
  • [Patent B] (e.g., WO 2018/123456): Covers [alternative approach or technical feature]
  • Academic references (e.g., [Reference 1]): Demonstrate [prior art or foundational science]

This dense patent environment raises concerns over freedom-to-operate (FTO). Companies and patent holders must navigate overlapping claims carefully, potentially leading to litigation or licensing negotiations.

Strategic Positioning

  • The '644 patent positions its assignee as a pioneer in [specific niche], providing leverage in licensing or cross-licensing negotiations.
  • Its claims' scope will directly influence its ability to block competitors or expand its portfolio through future filings.

Legal and Commercial Implications

The enforceability of the '644 patent hinges on claim validity and independent claim broadness. Should competitors challenge validity citing prior art or obviousness, the patent’s resilience will depend on the robustness of its disclosure and the novelty of its inventive concepts.

Commercially, the patent provides market exclusivity, enabling the patent holder to monetize via licensing or market monopoly. However, the patent landscape’s crowded nature necessitates diligent patent clearance and FTO analyses.


Critical Appraisal

The '644 patent exemplifies careful claim drafting and strategic positioning. Its scope balances breadth with the need for validity, aiming to carve out a defensible market niche. Nonetheless, the risk of invalidation due to prior art remains, especially if the claims hinge on elements with established antecedents.

Furthermore, as the artificial boundaries between patent claims and prior art evolve, ongoing patent prosecution and litigation will determine its ultimate strength.


Key Takeaways

  • The '644 patent’s claims are strategically constructed to secure broad yet defensible protection over [specific technology/innovative feature].
  • Its scope must be continuously monitored against evolving prior art and competitive filings, particularly in [the same or adjacent fields].
  • The dense patent landscape in [relevant technology] necessitates proactive FTO strategies and potential licensing negotiations.
  • The patent’s enforceability depends on maintaining novelty and overcoming validity challenges, especially given the rapid innovation in [industry sector].
  • The '644 patent provides a valuable asset, but its long-term commercial value hinges on maintaining its validity and strategic positioning within a dynamic patent ecosystem.

FAQs

  1. What is the core innovative feature of the '644 patent?
    The key inventive element centers on [brief description, e.g., a novel delivery mechanism, specific chemical structure, or manufacturing process], designed to [achieve specific advantages].

  2. How does the patent landscape affect the enforceability of the '644 patent?
    A crowded patent landscape increases risks of validity challenges. The '644 patent’s enforceability depends on its ability to distinguish itself over prior art and withstand invalidity assertions.

  3. Can the claims of the '644 patent be challenged in court?
    Yes. Challenges typically involve arguing prior art anticipation, obviousness, or indefiniteness. Its strength depends on the drafting quality and supporting disclosures.

  4. What strategies can a patent owner employ to maximize the value of the '644 patent?
    Strategies include vigilant monitoring of competitors’ patents, robust licensing programs, and defending against invalidity claims by strengthening patent prosecution and documentation.

  5. What are the implications for competitors aiming to design around the '644 patent?
    Competitors must analyze the claims carefully, identify non-infringing alternative approaches, or develop improvements that do not fall within the patent’s scope, all while avoiding infringement.


References

[1] MPEP §2107: Patentability— novelty and non-obviousness considerations

[2] Chisum on Patents, 2018: Claim construction principles and indefiniteness standards


Note: Specific details of the '644 patent, such as technical field, claims, and prior art references, should be incorporated as available or provided for more precise analysis.

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Details for Patent 10,159,644

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Glaxosmithkline Biologicals FLUARIX, FLUARIX QUADRIVALENT influenza vaccine Injection 125127 August 31, 2005 10,159,644 2033-10-25
Glaxosmithkline Biologicals FLUARIX, FLUARIX QUADRIVALENT influenza vaccine Injection 125127 December 14, 2012 10,159,644 2033-10-25
Id Biomedical Corporation Of Quebec FLULAVAL, FLULAVAL QUADRIVALENT influenza vaccine Injection 125163 October 05, 2006 10,159,644 2033-10-25
Id Biomedical Corporation Of Quebec FLULAVAL, FLULAVAL QUADRIVALENT influenza vaccine Injection 125163 November 10, 2009 10,159,644 2033-10-25
Id Biomedical Corporation Of Quebec FLULAVAL, FLULAVAL QUADRIVALENT influenza vaccine Injection 125163 August 15, 2013 10,159,644 2033-10-25
Id Biomedical Corporation Of Quebec FLULAVAL, FLULAVAL QUADRIVALENT influenza vaccine Injection 125163 September 27, 2013 10,159,644 2033-10-25
Seqirus Pty Ltd. AFLURIA, AFLURIA QUADRIVALENT influenza vaccine Injection 125254 September 28, 2007 10,159,644 2033-10-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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