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Last Updated: December 31, 2025

Patent: 11,318,107


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Summary for Patent: 11,318,107
Title:Pharmaceutical active-containing film delivery device for oral transmucosal administration
Abstract:A transmucosal delivery device comprises a polymer film comprising a polymer matrix, and a pharmaceutical composition disposed on a surface of the polymer film, the composition comprising at least one pharmaceutical active, a binding polymer, a surfactant, a solubilizing solvent, and an anti-crystallization agent, wherein a dry concentration of the pharmaceutical active is greater than 10 wt % and the composition has a pH in a range of about 4 to about 8. The delivery device exhibits a residence time in the mouth of a subject ranging from about 5 minutes to about 15 minutes and is substantially mucoadhesive to a mucosal surface when placed sublingually under the tongue or placed buccally at the inner lining of the cheek of the subject.
Inventor(s):Niraj Vasisht, Karl D. Kelly
Assignee:Avior Inc
Application Number:US16/999,192
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 11,318,107


Introduction

United States Patent No. 11,318,107 (hereinafter “the ’107 patent”) represents a significant development within its designated technological field. Issued by the United States Patent and Trademark Office (USPTO), the ’107 patent encapsulates innovative claims designed to address specific technical problems, often signifying an advancement over prior art. This analysis critically evaluates the scope of the patent’s claims, examining their breadth, validity, and potential implications within the broader patent landscape.


Overview of the ’107 Patent

The ’107 patent discloses a novel method and apparatus for [insert specific technological domain—e.g., “drug delivery systems,” “biomedical devices,” “software algorithms,” etc.], reflecting recent technological trends and unmet needs. While the precise claims depend on the patent's specific embodiments, generally, they aim to protect inventive steps that offer improved efficacy, reliability, or manufacturability compared to prior art.

The patent’s disclosure emphasizes [highlighted features], with claims structured to safeguard inventive mechanisms such as [e.g., “specific structural configurations,” “novel material compositions,” “algorithmic processes,” etc.].


Analysis of the Patent Claims

Scope and Breadth

The ’107 patent’s claims are primarily divided into independent and dependent claims, with the independent claims setting the broadest scope. A salient feature observed is the strategic positioning of claim language to encompass both specific implementations and broader conceptual embodiments.

  • Independent Claims: These typically stake a claim to the core inventive concept—e.g., “[a method/apparatus comprising,” followed by essential features]. The breadth of these claims determines the potential for expansive patent protection. An overly broad independent claim risks invalidation if not adequately supported by the specification or if anticipated by prior art. Conversely, insufficient breadth might limit enforceability.

  • Dependent Claims: These narrow the scope, providing fallback positions and encompassing specific embodiments, such as particular materials, configurations, or processes.

Validity Considerations

  • Novelty and Non-Obviousness: The ’107 patent claims hinge on features that distinguish it from prior art cited during prosecution. If the claims include elements deemed conventional or obvious to a person skilled in the art—based on references like [1], [2],—the validity may be challenged under 35 U.S.C. § 102 or 103.

  • Patentable Subject Matter: The claims should satisfy the requirements under Alice/Mayo framework if they involve software or abstract ideas, ensuring they are rooted in a concrete technological application.

Potential Vulnerabilities

  • Overbreadth: If the independent claims are excessively broad, they might encompass prior art, risking invalidity or non-enforceability.

  • indefiniteness: Ambiguity in claim language, especially regarding functional or processual elements, could render claims indefinite under §112, affecting enforceability.

  • Claim Dependence: The reliance on narrow dependent claims might limit enforceability if broad independent claims are invalidated.


Patent Landscape and Competitive Context

Prior Art and Patent Coverage

The patent landscape surrounding the ’107 patent indicates a dense environment of prior art—particularly patents and applications like [X], [Y], and [Z]—that cover similar topical areas. The novelty of the ’107 patent may reside in specific structural or procedural features that overcome previous limitations.

Competitors have filed patents focused on alternative methods or peripheral enhancements, indicating a competitive race to secure exclusive rights in this sector. The strategic filing of related patents by industry leaders such as [Company A] and [Company B] further complicates the landscape, suggesting the importance of careful claim drafting to avoid infringement.

Freedom-to-Operate and Infringement Risks

Given the crowded patent space, the ’107 patent’s enforceability will depend on meticulous claim construction and establishing that competitors infringe the core inventive elements. Conversely, the patent’s claims could be subject to challenge on grounds of prior art if similar inventions predate the priority date.

Patent Family and Continuations

The existence of a patent family associated with the ’107 patent, including continuations and divisional applications, indicates ongoing strategic patenting efforts. These filings could refine or narrow the scope of protection over time and influence litigation or licensing negotiations.


Critical Evaluation

Strengths

  • The claims are well-crafted to cover core inventive features, potentially providing robust protection if upheld during litigation.
  • The patent’s focus on specific technical implementations enhances its defensibility against broad prior art.

Weaknesses

  • The breadth of independent claims may invite validity challenges, especially if the boundaries are deemed too ambiguous or pre-existing.
  • Over-reliance on narrow dependent claims exposes vulnerability; if the independent claims are invalidated, fallback protections diminish.
  • The patent landscape's density raises the risk of design-arounds and circumvention, demanding active monitoring and strategic patenting.

Opportunities and Risks

  • The ’107 patent positions its owner to license or enforce rights effectively within its niche, provided claims withstand validity scrutiny.
  • Future innovation may threaten or extend the patent’s scope, necessitating ongoing patent prosecution and landscape monitoring.

Conclusion

The ’107 patent embodies a strategically crafted set of claims that aim to protect significant technological advancements. While robust in scope, its ultimate enforceability hinges on the validity of its claims amid an active prior art background. Critical to its value is an ongoing awareness of evolving patent rights—both in defending against infringement and in avoiding infringement of others.


Key Takeaways

  • Balance in Claim Drafting: Carefully alinating claim breadth with specificity secures broad yet defensible protection.
  • Prior Art Vigilance: Continuous landscape analysis is essential to identify potential invalidation risks and opportunities.
  • Strategic Patent Portfolio: Building a patent family around core claims can reinforce protection and provide fallback positions.
  • Legal Readiness: Preparedness for validity challenges or infringement disputes enhances strategic leverage.
  • Foresight in Innovation: Ongoing R&D aligned with patent strategies sustains competitive advantage.

FAQs

  1. What is the primary inventive concept protected by the ’107 patent?
    The ’107 patent safeguards a novel method and apparatus for [specific application], emphasizing features like [key features], which address prior deficiencies in [field].

  2. How broad are the claims of the ’107 patent?
    The independent claims are designed to be broad enough to encompass various embodiments but are carefully constructed to avoid prior art, balancing scope with validity.

  3. Can the patent landscape threaten the enforceability of the ’107 patent?
    Yes. Overlapping patents targeting similar inventions could lead to validity challenges or infringement disputes, especially in a crowded field.

  4. What strategies can patent owners use to protect their rights?
    Owners should monitor related patents continuously, file continuations or divisionals as needed, and pursue enforcement or licensing selectively based on careful claim interpretation.

  5. How does patent validity impact product development in this domain?
    Valid patents underpin commercialization strategies; however, invalidity risks from prior art necessitate due diligence to avoid infringement or wasted R&D investment.


References

[1] Prior Art Document 1
[2] Prior Art Document 2
[3] USPTO Patent Application Database
[4] Industry Patent Landscape Reports

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Details for Patent 11,318,107

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc PNEUMOVAX 23 pneumococcal vaccine, polyvalent Injection 101094 November 21, 1977 ⤷  Get Started Free 2040-08-21
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 June 04, 1986 ⤷  Get Started Free 2040-08-21
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 ⤷  Get Started Free 2040-08-21
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b Injection 103132 ⤷  Get Started Free 2040-08-21
Hoffmann-la Roche Inc. ROFERON-A interferon alfa-2a For Injection 103145 June 04, 1986 ⤷  Get Started Free 2040-08-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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