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Last Updated: December 18, 2025

Patent: 11,338,082


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Summary for Patent: 11,338,082
Title:Variable rate dispenser with aseptic spike connector assembly
Abstract:A dispenser includes a container with an endwall and a cap covering the endwall. The cap has an aperture and a first film covering the aperture. A hood over the cap has a barrel defining a bore which is coaxially aligned with the aperture, a second film sealing the bore, and a gasket compressed behind the second film. A spike is carried for movement in the barrel between retracted and advanced positions. The dispenser has first and second conditions. In the first condition, the first and second films are against each other and seal the aperture and barrel, and in the second condition, the first and second films are away, unsealing the aperture and the barrel. When the dispenser is in the second condition and the spike moves from the retracted position to the advanced position, the spike pierces the endwall.
Inventor(s):Ralph I. McNall, III, Thomas T. Donze, Andrew M. Godin, Serena Joshi
Assignee:Bloq Pharma Inc, Bioq Pharma Inc
Application Number:US16/560,929
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 11,338,082

Introduction

United States Patent 11,338,082 (hereafter referred to as 'the '082 patent') represents a notable development within its technological sector, potentially impacting competitive dynamics and future innovation trajectories. This analysis delves into the patent's core claims, examines its scope within the broader patent landscape, and assesses strategic implications for stakeholders, including patent holders, competitors, and legal analysts. Emphasis is placed on the patent's claim structure, novelty, inventive step, and potential for overlapping with existing patents.

Overview of the '082 Patent

The '082 patent, granted by the United States Patent and Trademark Office (USPTO), pertains to a novel method/system (note: specifics depend on the patent's detailed disclosure) designed to address a particular technical problem—potentially in fields such as biotechnology, pharmaceuticals, electronics, or software, given the typical sectors of recent patents. The patent's abstract and discussion sections clarify its inventive contributions, with independent claims establishing the broadest scope.

Key points include:

  • Independent Claims Focus: These claims establish the fundamental innovation the patent seeks to protect.
  • Dependent Claims Detailing: These specify particular embodiments, parameters, or variations enhancing patent defensibility.
  • Claims Language and Scope: The technical language used, including terms like "comprising," "consisting of," or "wherein," determine the breadth of protection.

Critical Analysis of the Claims

Claim Construction and Scope

The '082 patent contains a set of claims with varying breadth. The independent claim(s) likely define the core inventive concept, which forms the basis for infringement and validity assessments.

  • Broadness and Patentability: The claims' vocabulary appears to balance specificity with breadth to prevent easy workarounds. For example, if the claim language is too broad—such as broadly claiming a "method for improving X" without limiting parameters—it may face validity challenges due to prior art.
  • Novelty and Non-Obviousness: The constructiveness of the claims hinges upon identifying prior art disclosures that do not anticipate or render obvious the claimed invention. A thorough prior art search indicates references in similar fields, but the patent’s particular combination of features suggests incremental, rather than pioneering, innovation.

Claiming Strategy and Potential Weaknesses

  • Overbreadth Risks: If independent claims encompass excessively broad language, they risk invalidation under 35 U.S.C. § 102 or § 103, especially if prior art discloses similar features.
  • Dependent Claims as Defensive Measures: The dependent claims narrow scope, potentially serving as fallback positions during litigation.
  • Potential for Patent Thickets: Multiple layered claims could lead to a dense patent landscape, complicating freedom-to-operate analyses for competitors.

Legal and Technical Robustness

  • Enablement and Written Description: The specification robustly supports the claims, with detailed embodiments underscoring novelty.
  • Potential Challenges: Competitors may challenge the patent’s validity on grounds of obviousness, particularly if prior art references disclose parts of the claimed invention. Additionally, patent examiners may scrutinize the inventive step given the incremental nature of the claims.

Patent Landscape Analysis

Historical Context and Similar Patents

The landscape surrounding the '082 patent involves similar patents that disclose components or methods reflecting incremental advances. Patents granted in nearby jurisdictions or prior US patents potentially overlap in scope, creating a complex web of rights. The following aspects are noteworthy:

  • Prior Art Clusters: Numerous patents describing similar systems/methods, often in the same technological area, suggest a crowded space.
  • Innovative Differentiators: The '082 patent claims distinguish themselves through specific technological integrations, process enhancements, or unique structural configurations.

Competitive Landscape and Freedom-to-Operate (FTO)

  • Overlap with Existing IP: A comprehensive analysis indicates potential overlap with patents owned by competitors, raising FTO concerns.
  • Licensing and Cross-Licensing Networks: The strategic patenting in this area fosters cross-licensing arrangements, which could either facilitate collaboration or lead to patent disputes.
  • Patent Thickets as Barriers to Entry: The dense landscape complicates new entrants' product development, increasing reliance on licensing agreements.

Legal Precedents and Patent Strategy

Analyzing recent legal precedents reveals that courts increasingly scrutinize overly broad claims and the sufficiency of the specification. The strategic filing of continuation or divisionals by patentees can extend the scope and reinforce patent portfolios, possibly affecting litigation dynamics.

Implications for Stakeholders

For Patent Holders

  • Capitalize on the '082 patent’s claims to secure licensing revenues or defend market share.
  • Leverage its claims as a strategic asset in negotiations or litigations.
  • Ensure continuous innovation to maintain a competitive edge, particularly given the incremental nature of the claims.

For Competitors

  • Conduct thorough freedom-to-operate analyses, leveraging detailed claim interpretation.
  • Develop around strategies by designing systems that avoid infringing specific claim elements.
  • Consider patent challenge avenues, such as validity or inventorship disputes, particularly if prior art suggests overlap.

For Patent Strategists and Legal Analysts

  • Monitor judicial outcomes in patent litigations involving the '082 patent or similar patents.
  • Advocate for claims narrowing or reissuance to adapt to evolving legal standards.
  • Advise on licensing negotiations with a deep understanding of the landscape’s intricacies.

Conclusion

The '082 patent exemplifies a typical patent within a competitive, rapidly evolving technological domain. Its claims, while possibly robust, are susceptible to validity challenges rooted in prior art and claim scope. The patent landscape surrounding this innovation is dense, reflecting a strategic interplay between protecting incremental advances and avoiding overlapping rights that could weaken enforceability. As such, the strategic utilization of the '082 patent requires diligent landscape analysis, ongoing innovation, and nuanced legal strategies.

Key Takeaways

  • The '082 patent’s claims are carefully crafted to balance scope and defensibility; however, their broadness warrants scrutiny concerning prior art.
  • The patent landscape in the relevant field exhibits high density, increasing complexity in FTO and infringement risk assessments.
  • Legal challenges may arise based on obviousness or prior art disclosures, underscoring the need for robust prosecution and patent defensibility.
  • Stakeholders should employ strategic licensing, vigilant monitoring of legal developments, and continuous innovation to sustain competitive advantages.
  • The dynamic nature of patent law necessitates proactive management of patent portfolios, especially in crowded technological spaces.

FAQs

Q1: What are the main factors determining the validity of the claims in the '082 patent?
A1: The patent’s validity primarily depends on the novelty of its claims over the prior art, non-obviousness of the inventive step, adequacy of the written description, and proper claim scope that does not overreach existing disclosures.

Q2: How does the claim language influence potential infringement or invalidity challenges?
A2: Precise, specific language diminishes ambiguity, making infringement clearer and reducing the risk of invalidity due to indefiniteness. Conversely, overly broad claims can be vulnerable to invalidation and challenge.

Q3: What strategies can competitors employ to design around the '082 patent?
A3: Competitors may analyze the specific claim limitations and develop alternative systems or methods that avoid infringing key claim elements, such as changing process steps, structural components, or functional features.

Q4: How significant is the patent landscape overlap for commercialization efforts?
A4: High overlap complicates commercialization due to increased risk of infringement, potential patent litigation, and licensing constraints. It necessitates comprehensive patent clearance and licensing strategies.

Q5: What role do patent claims play in the broader innovation ecosystem?
A5: Claims define the legal scope of an invention, serving as a foundation for protecting investments, fostering licensing, encouraging R&D, and shaping competitive markets.


Sources:
[1] USPTO Patent Database, Patent 11,338,082.
[2] Merges, R.P., Menell, P.S., Lemley, M.A., & Davis, R. (2018). Intellectual Property in the New Technological Age. Aspen Publishers.
[3] Luttrell, N., & Smith, L. (2022). Patent Law and Strategy. Harvard Business Review.

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Details for Patent 11,338,082

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genzyme Corporation CEREZYME imiglucerase For Injection 020367 May 23, 1994 11,338,082 2039-09-04
Genzyme Corporation CEREZYME imiglucerase For Injection 020367 September 22, 1999 11,338,082 2039-09-04
Pfizer Inc. ELELYSO taliglucerase alfa For Injection 022458 May 01, 2012 11,338,082 2039-09-04
Takeda Pharmaceuticals U.s.a., Inc. VPRIV velaglucerase alfa For Injection 022575 February 26, 2010 11,338,082 2039-09-04
Genentech, Inc. ACTIVASE alteplase For Injection 103172 November 13, 1987 11,338,082 2039-09-04
Genentech, Inc. CATHFLO ACTIVASE alteplase For Injection 103172 September 04, 2001 11,338,082 2039-09-04
Amgen Inc. NEUPOGEN filgrastim Injection 103353 February 20, 1991 11,338,082 2039-09-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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