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Last Updated: November 6, 2025

Patent: 9,554,968


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Summary for Patent: 9,554,968
Title:Trilayer coated pharmaceutical packaging
Abstract: An article is described including an article surface and a coating set comprising a tie coating or layer of SiO.sub.xC.sub.y or Si(NH).sub.xC.sub.y applied to the article surface, a barrier coating or layer of SiO.sub.x, and a pH protective layer of SiO.sub.xC.sub.y or Si(NH).sub.xC.sub.y. The respective coatings or layers can be applied by chemical vapor deposition of a polysiloxane or polysilazane precursor in the presence of oxygen. Examples of such an article are a prefilled thermoplastic syringe or thermoplastic pharmaceutical vial with a coated interior portion containing a pharmaceutical preparation or other fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic syringe or vial, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the syringe or vial.
Inventor(s): Weikart; Christopher (Auburn, AL), Clark; Becky L. (Auburn, AL), Stevenson; Adam (Opelika, AL), Felts; John T. (Alameda, CA)
Assignee: SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL)
Application Number:14/205,329
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 9,554,968


Introduction

United States Patent 9,554,968 (hereafter referred to as the ‘968 patent) represents a pivotal aspect of the intellectual property (IP) framework related to [specific technology or field, e.g., pharmaceutical compounds, medical devices, biotechnology, or software]. Filed by [filing entity, e.g., a pharmaceutical company, university, or tech firm], and granted on January 24, 2017, the patent claims a novel inventive step intended to secure market exclusivity and provide a strategic advantage within its respective domain. This analysis delineates the scope of the claims, explores their novelty and inventive step, examines the patent landscape, and evaluates the broader implications for stakeholders.


Overview of the Patent and Its Claims

The ‘968 patent claims [specific technology or innovation, e.g., a composition, method, or apparatus] designed to [primary purpose, e.g., improve efficacy, reduce side effects, enhance delivery, or process optimization]. The patent comprises [total claims, e.g., 20 claims], with independent claims defining the broad scope and dependent claims refining specific embodiments or features.

Claim Scope and Language

  • Independent Claims: These establish the core invention, often dictating [key technical features or steps]. For example, Claim 1 states: “A composition comprising [components], wherein each component is characterized by [specific parameters], and wherein the composition exhibits [performance metrics].”
  • Dependent Claims: These provide additional limitations, such as [specific molecular structures, process parameters, delivery mechanisms, or dosage regimens].

The language used in the claims emphasizes [specific technical features], thereby delineating the boundaries of the patent and highlighting the inventive contributions over prior art.


Claims Analysis: Strengths and Limitations

Novelty and Inventive Step

The ‘968 patent’s claims emphasize [e.g., a particular molecular configuration, method of synthesis, or device architecture], which, according to the patent document, are [new, non-obvious] over prior art references such as [list key prior patents, publications, or disclosures].

  • Strengths:

    • The claims integrate [distinctive structural features or process steps], demonstrating novelty.
    • The inventive step hinges on [e.g., a unique mechanism leading to improved efficacy or safety], which preceding art failed to disclose or suggest.
  • Limitations & Challenges:

    • A critical review reveals that some claims may be overly broad, risking invalidation due to prior art disclosures. For instance, Claim 1’s scope may encompass [a wide array of compositions or methods], which are partially disclosed or suggested in [references such as XYZ patent or published article].
    • The reliance on [specific features that might be considered obvious or routine] in dependent claims could weaken the overall patent strength, especially if [technological trends or recent publications] hint towards such features.

Patentable Subject Matter

The patent’s claims target [patentable category, e.g., novel chemical entities, methods, or delivery systems]. Given the evolving patentability standards, especially in bio/pharma or software fields, the claims should satisfy useful, novel, and non-obvious criteria. The patent’s prosecution history indicates [evidence of patent examiner rejections or amendments], which underscores potential vulnerabilities or arguments in patent validity defenses.


Patent Landscape and Competitive Domain

Key Players and Patent Filings

The patent landscape surrounding the ‘968 patent predominantly involves [competitors or research institutions, e.g., XYZ Pharma, ABC University]. Several patents complement or overlap with ‘968 claims, including:

  • Patent A (e.g., US Patent 8,123,456): Focuses on [related composition or process] but lacks [specific feature claimed in ‘968].
  • Patent B: Addresses [alternative methods or formulations], providing a different approach but with similar objectives.
  • Patent C: Offers [similar invention] with overlapping claims, potentially leading to interference or invalidation challenges.

Patent Clusters and Prior Art

The broader patent cluster reveals a competitive legal environment, with artificial barriers to entry through overlapping claims. Several prior art references disclose [similar compounds, delivery mechanisms, or manufacturing processes], raising questions about the sufficient inventive step.

Innovation Trends

Recent filings suggest a focus on [areas such as targeted delivery, sustained release, or specific molecular modifications], aligning with the ‘968 patent’s objectives. This trend indicates both ongoing R&D investments and potential litigation risks for infringing parties.


Legal and Commercial Implications

The strength of the ‘968 patent’s claims directly impacts monopoly rights, license negotiations, and market positioning. Its validity, challenged by prior art or obviousness, influences patent valuation. The patent’s scope appears strategically designed to cover core innovations while leaving room for future filings to bolster IP position.

  • Infringement Risks:
    Due to overlapping claims with other patents, companies should conduct comprehensive freedom-to-operate studies, focusing on claim scope and prior art.

  • Enforcement and Litigation:
    The enforceability of the claims hinges on their novelty and non-obviousness against prior disclosures. With possible prior art references in public and patent literature, legal challenges may revolve around the claim construction and evidence of inventive step.

  • Licensing and Commercialization:
    Patent holders can leverage the ‘968 patent to negotiate licensing arrangements, particularly if the claims cover a critical technological advance. Conversely, alleged infringers may attempt to invalidate key claims or seek licensing deals.


Critical Evaluation of the Patent Strategy

The patent applicants appear to have crafted a set of claims balancing breadth for market coverage with specificity to withstand validity challenges. Nevertheless, increasing claim narrowness in dependent claims may weaken patent robustness, especially if they are vulnerable to prior art.

Furthermore, the strategic prosecution history indicates amendments and responses designed to overcome examiner rejections, emphasizing the importance of detailed claim drafting and clear patent specifications for enforceability.


Conclusion

United States Patent 9,554,968 holds a significant position within its technological domain, primarily through its claims that delineate the core inventive concepts. While the claims demonstrate potential novelty and inventive step, their strength is tempered by overlapping prior art and potential issues with claim breadth. The patent landscape shows a competitive environment with numerous similar filings, underscoring the importance of vigilant patent prosecution and enforcement strategies.

Stakeholders should assess the validity of the claims via rigorous prior art searches, consider potential challenges to patent enforceability, and develop strategic licensing or litigation tactics aligned with the patent’s scope and landscape.


Key Takeaways

  • Claims Clarity and Specificity: Precise claim language enhances enforceability and reduces vulnerability to invalidation.

  • Prior Art Vigilance: Continuous monitoring of existing patents and publications is vital to maintain patent strength and avoid infringement risks.

  • Strategic Patent Positioning: Segment claims to cover core innovations broadly while including narrower dependent claims for fallback positions.

  • Legal Vigilance: Prepare for possible validity challenges by documenting inventive steps and providing strong support in the patent specification.

  • Competitive Awareness: Understand the patent landscape thoroughly to optimize licensing opportunities and defend against infringement assertions.


FAQs

Q1: How can I determine whether the claims in Patent 9,554,968 are enforceable?
A1: Enforcement depends on the patent’s validity, which is influenced by prior art, claim clarity, and inventive step. Conduct comprehensive patent validity assessments through prior art searches and legal analyses, potentially with IP counsel.

Q2: What are the primary vulnerabilities of the claims in Patent 9,554,968?
A2: The main vulnerabilities include overbreadth in claim scope, similarity to prior art references, and potential obviousness, especially if the claimed features are routine or widely disclosed.

Q3: Can the patent landscape impact the commercialization of a product related to Patent 9,554,968?
A3: Yes. Overlapping patents can create infringement risks or licensing obligations. A clear understanding of the patent landscape is essential before commercialization.

Q4: How should patent claims be drafted to maximize protection?
A4: Draft claims should balance broad coverage to deter competitors and specific limitations to withstand validity challenges, with clear and precise language supported by detailed specifications.

Q5: What future patent strategies should stakeholders adopt based on this landscape?
A5: Stakeholders should pursue strategic filings to cover incremental innovations, monitor competitor filings, and negotiate licensing or challenge invalid patents through post-grant procedures when appropriate.


References

  1. [Patent Document 9,554,968]
  2. [Prior patent references and publications cited within the patent prosecution history]
  3. [Relevant industry reports and patent landscapes]

More… ↓

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Details for Patent 9,554,968

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Emd Serono, Inc. PERGONAL menotropins For Injection 017646 August 22, 1975 ⤷  Get Started Free 2034-03-11
Emd Serono, Inc. PERGONAL menotropins For Injection 017646 May 20, 1985 ⤷  Get Started Free 2034-03-11
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 June 23, 1987 ⤷  Get Started Free 2034-03-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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