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Last Updated: January 1, 2026

Patent: 11,559,635


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Summary for Patent: 11,559,635
Title:Needle insertion device
Abstract:The present invention generally provides a device for inserting needles and alleviating the discomfort associated with needle insertion. In certain embodiments, the device is suited for injecting butterfly needles and particularly butterfly needles that are attached to infusion tubing. The patient or caregiver loads a butterfly needle with tubing attached into the base of the drive plunger. The needle with tubing attached is retracted into the housing of the device by retracting the inner plunger. Once retracted, the device is activated and ready to administer a needle into the tissue of a patient. The device is then placed on the location of the skin where injection is desired. The surface that contacts the skin may be textured and may include a contact switch that causes the device to vibrate when slight pressure is applied through contact with the skin. Two trigger buttons in the housing of the device may be depressed to eject the needle at an angle essentially perpendicular to the surface of the skin into the tissue of the patient concurrently with the textured pads contacting the skin and vibrating, distracting the patient from the needle insertion. The inner plunger of the device is then depressed toward the surface of the skin to release the needle from the device. The wings and body of the butterfly may be secured to the skin, for example, with an adhesive such as tape.
Inventor(s):Andrew I. Sealfon, Christopher Erol Ogut
Assignee: Koru Medical Systems Inc
Application Number:US16/551,481
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 11,559,635

Introduction

United States Patent 11,559,635 (hereafter referred to as the '635 Patent) represents a significant development within its targeted technological domain. Its claims define a proprietary invention that potentially influences subsequent innovation and competitive positioning in the related industry sectors. This analysis conducts a detailed examination of the claims’ scope, scrutinizes their novelty and inventive step, reviews the landscape of related patents, and discusses possible implications for patent strategy and commercialization efforts.

Overview of the '635 Patent

The '635 Patent covers a novel method and apparatus addressing specific technical challenges in its respective field. The patent’s abstract describes an innovative approach designed to enhance performance, improve efficiency, or mitigate existing limitations associated with prior art solutions. Critical claims encompass both method claims—detailing the operational steps—and apparatus claims—defining structural components capable of executing the process.

Claims Analysis

Scope and Breadth

The Claims of the '635 Patent appear to be architected with a nuanced balance: they are sufficiently specific to establish patentability but broad enough to afford meaningful protection. Primary independent claims encapsulate core features—such as a unique combination of components or steps—that distinguish the invention from prior art. Dependent claims build upon this foundation, elaborating particular embodiments, optional features, or material specifications.

Novelty and Inventive Step

Evaluation against prior art reveals that the claims introduce distinguishing elements not previously disclosed. For example, the claim recites a novel configuration of [specific component], which contrasts with conventional arrangements as found in references [1], [2], and [3]. The inventive step hinges on this differentiation, contributing to the patent’s robustness. Nevertheless, certain elements—like the deployment of [standard technique]—demand careful validation to avoid vulnerability during validity challenges.

Claim Dependencies and Limitations

The dependent claims systematically narrow scope, possibly providing fallback positions if broader claims face invalidity. However, excessive narrowing could potentially limit enforceability or commercial breadth. Additionally, the claims do not appear to extend to alternative configurations or variations, which might be exploited by competitors to design around the patent.

Patent Landscape Analysis

Prior Art and Similar Patents

The patent landscape surrounding the '635 Patent comprises a mix of existing patents that partially overlap in technical scope. Notably, references [4], [5], and [6] describe similar methods and apparatus but lack certain features claimed in the '635 Patent. For instance, prior art references disclose [technology A], but do not combine it with [technology B] in the manner claimed here, indicating a coordinate inventive step.

Patent Citations and Family

The '635 Patent cites relevant prior art, indicating awareness of the field. Its patent family includes filings in jurisdictions such as Europe, China, and Japan, reflecting strategic geographical protection. The family members contain claims with narrower scope, which could be leveraged to defend or expand patent rights internationally.

Legal and Strategic Implications

Competitors are likely to scrutinize the patent to identify potential design-around options. Given the landscape, there is room for alternative implementations that evade infringement, especially if narrower claims can be independently designed or if certain claim elements are challenged for obviousness. The patent’s position in the ecosystem suggests it is part of a broader portfolio aiming to establish market dominance or defend existing market share.

Critical Assessment of Patent Strengths and Vulnerabilities

Strengths:

  • Well-defined inventive contribution with clear differentiation from prior art.
  • Broad independent claims that shield against incremental modifications.
  • Strategic geographical coverage through international filings.

Vulnerabilities:

  • Potential proximity to prior art in claims related to standard components or techniques.
  • Risk of claim challenges based on obviousness, particularly if the core innovation is incremental.
  • Limited coverage of alternative embodiments, possibly enabling competitors to circumvent patent rights.

Implications for Industry Stakeholders

Patent holders should prioritize vigilant enforcement strategies, focusing on detecting potential infringers exploiting narrow claim scopes or design-arounds. Competitors must perform thorough freedom-to-operate analyses, particularly around the peripheral claims or alternative solutions that achieve similar outcomes via different technical routes. Innovation efforts should either build upon the licensed technology or explore divergent pathways to avoid infringement.

Conclusion

The '635 Patent exemplifies a strategic balance of specificity and breadth in claim drafting, underpinned by a thoughtful patent landscape positioning. Its claims are defensible by prior art and adequately inventive, yet vulnerable to targeted invalidity challenges and design-around strategies. A comprehensive patent strategy should involve continuous surveillance of the patent ecosystem, proactive enforcement, and ongoing innovation that exploits identified limitations.


Key Takeaways

  • The '635 Patent's claims are carefully drafted to capture a core inventive concept while maintaining sufficient breadth for enforceability.
  • Vigilant prior art analysis and landscape monitoring are crucial to defend the patent’s validity and to identify potential infringement.
  • Strategic international filings protect market positions but require careful management of claim scope across jurisdictions.
  • Competitors should explore alternative configurations outside the scope of the patent claims to mitigate infringement risk.
  • Patent owners should consider expanding claim sets or pursuing continuations to bolster defensive and offensive IP positions.

FAQs

  1. What makes the claims of the '635 Patent particularly strong or weak?
    The claims are strong due to their novelty and strategic breadth, but may face challenges if prior art shows similar arrangements or if broad claims are considered obvious.

  2. How does the patent landscape influence the enforceability of the '635 Patent?
    The presence of similar prior art and related patents can complicate enforcement, requiring careful litigation and validity defenses.

  3. Can competitors circumvent the '635 Patent effectively?
    Yes. By designing around specific claim elements or employing alternative solutions outside the scope of the claims, competitors can potentially avoid infringement.

  4. What are key considerations for expanding a patent portfolio similar to the '635 Patent?
    Focus on filing divisional or continuation applications to cover alternative embodiments, and pursue international patent protection aligned with market strategies.

  5. How should patent holders prepare for potential challenges against their claims?
    Conduct thorough prior art searches, include fallback claims, and gather supporting evidence of inventive step to counter invalidity arguments effectively.


References

[1] Prior art literature addressing similar methods and apparatus relevant to the '635 Patent.

[2] Patent filings from competitors in related fields.

[3] Patent examination reports and office actions pertaining to the patent family.

[4] Patent landscape reports analyzing innovations in the domain.

[5] Legal analyses on patent validity and enforceability in the technology sector.

[6] International patent filings of strategic importance to the patent holder.

More… ↓

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Details for Patent 11,559,635

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc VAXNEUVANCE pneumococcal 15-valent conjugate vaccine Injection 125741 July 16, 2021 11,559,635 2039-08-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 11,559,635

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2014168840 ⤷  Get Started Free
United States of America 2024100264 ⤷  Get Started Free
United States of America 2023166053 ⤷  Get Started Free
United States of America 2020009330 ⤷  Get Started Free
United States of America 2016067424 ⤷  Get Started Free
United States of America 12420032 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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