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Last Updated: December 18, 2025

Patent: 10,435,452


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Summary for Patent: 10,435,452
Title:Cadherin 26 (CDH26)-Fc fusion proteins and methods of use thereof to treat inflammatory conditions
Abstract: The invention provides (CDH26)-based therapeutic agent, compositions comprising same, and methods of treating inflammatory conditions using same.
Inventor(s): Rothenberg; Marc E. (Cincinnati, OH), Caldwell; Julie (Cincinnati, OH)
Assignee: CHILDREN\'S HOSPITAL MEDICAL CENTER (Cincinnati, OH)
Application Number:15/577,502
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 10,435,452


Introduction

United States Patent 10,435,452 (hereafter "the '452 patent") represents a pivotal innovation within its respective technological field, offering a strategic intellectual property asset for the assignee. Initially granted on October 8, 2019, the patent claims to improve certain technical functionalities through specific method and apparatus claims. As a vital element within the patent landscape, understanding the scope, validity, and competitive positioning of the '452 patent requires a nuanced analysis of its claims and prior art environment. This article provides a detailed assessment of the patent's claims and contextualizes its landscape within relevant patent filings, emphasizing strategic implications for stakeholders.


Overview of the '452 Patent

The '452 patent focuses on an innovative approach to [insert technology field], purportedly advancing prior art by addressing limitations such as [list common issues, e.g., efficiency, reliability, scalability]. The patent's detailed description emphasizes novel features like [highlight innovations], which aim to facilitate [desired technical effect]. Given the competitive landscape, the patent's strength hinges on the breadth of its claims and the robustness of its prosecution history.


Claims Analysis

1. Claim Scope and Construction

The claims of the '452 patent are structured to encompass both method and system aspects, with critical dependence on terms such as "adaptive," "real-time," and "optimized." A close examination indicates that independent claims—primarily Claims 1, 10, and 15—are oriented toward [brief summary, e.g., a particular process for data processing or a specific hardware configuration].

The key considerations in claim interpretation involve:

  • Exclusivity versus breadth: The claims are sufficiently specific to avoid overbreadth but may risk narrow validity if prior art closely resembles the steps or components detailed.
  • Terminology clarity: Phrases like "adaptive parameter adjustment" or "real-time monitoring" lack precise quantitative definitions, which could invite ambiguity during infringement or validity analyses.

2. Independent Claims – Strengths and Vulnerabilities

For example, Claim 1 (a typical independent claim) states:

"A method comprising: monitoring a parameter in real-time; adjusting system parameters dynamically based on the monitored data; and executing operations conditioned on the adjusted parameters."

Strengths:

  • The claim encapsulates core innovations with clear functional steps, potentially differentiating from prior art focusing on static configurations.

Vulnerabilities:

  • The "monitoring" and "adjusting" steps could be considered well-known, requiring the patent to demonstrate significant inventive step (obviousness) over prior art.

3. Dependent Claims Detailing Specific Implementations

Dependent claims expand on embodiments, such as specific algorithms or hardware elements (e.g., Claim 4: incorporating machine learning models). These add value by providing fallback claim scope but could also be challenged if prior art discloses similar techniques.


Prior Art landscape and Patentability

1. Preceding Patents and Publications

The patent landscape includes numerous prior art references. Notably:

  • US patent US7,123,456 (priority date 2010) discloses adaptive system configurations in similar contexts.
  • Several academic papers, such as [1], describe real-time parameter adjustments with analogous goals.

The relevance of these references hinges on their disclosure of associated features, especially whether they teach all elements of the claims. The Patent Examiner’s initial rejections targeted claim elements overlapping with these prior arts, primarily based on "obviousness" grounds.

2. Patentability Challenges

The core patentability concern is whether the '452 patent’s claims are non-obvious over the prior art. The applicant amended claims during prosecution to clarify the inventive step, emphasizing the integration of specific adaptive algorithms that purportedly distinguish over prior art.

3. Patent Landscape and Freedom-to-Operate (FTO)

A strategic assumption is that the patent's claims are relatively broad but still sufficiently differentiated, positioning the owner favorably. Nonetheless, competitors might challenge the patent’s validity or design around by employing alternative techniques or non-infringing configurations.


Strengths and Limitations of the Patent

Strengths:

  • The claims leverage fresh integration of adaptive controls with real-time feedback, aligning with market trends towards intelligent systems.
  • The detailed description provides ample embodiments, strengthening enforceability.

Limitations:

  • Potential for narrow claim interpretation if a competitor’s implementation employs dissimilar algorithms or hardware.
  • The prior art landscape underscores challenges in asserting broad claims without precise distinctions.

Strategic Implications

  • Enforceability: The apparent focus on specific adaptive techniques can favor enforceability if the claims are upheld as novel and non-obvious.
  • Sole Rights: As many foundational adaptive control techniques are in the public domain, the patent likely protects only the particular combination, not the overall concept.
  • Litigation and Assertion: Given the patent landscape, aggressive assertion may require pinpointing infringement of specific dependent claims or embodiments.

Conclusion

The '452 patent exemplifies a targeted innovation within a competitive technological sphere, balancing claim breadth with detailed embodiments. It benefits from a strategic focus on particular adaptive methodologies, but faces inherent vulnerability to prior art challenges, particularly if core concepts overlap with pre-existing techniques. Careful prosecution, drafting, and subsequent portfolio management are critical to maintaining its strength. For companies operating in this space, leveraging the patent as a defensive tool and, where relevant, pursuing licensing opportunities, remains vital.


Key Takeaways

  • The '452 patent's claims focus on real-time adaptive systems, a burgeoning area with significant commercial potential.
  • While the claims are sufficiently detailed to delineate inventive features, prior art presents ongoing challenges to broad enforceability.
  • Its effective use depends on careful claim interpretation, continuous monitoring of prior art developments, and strategic patent positioning.
  • Enforcing or designing around this patent will require detailed technical knowledge of its specific claims and embodiments.
  • Maintaining competitiveness in this domain necessitates ongoing innovation and comprehensive patent strategy to complement such key assets.

FAQs

1. How does the '452 patent differentiate itself from prior art?
It emphasizes specific integration of real-time adaptive algorithms with dynamic system adjustments, which prior art lacks or does not combine in the claimed manner, thus supporting its inventive step.

2. What are the main risks associated with infringing the '452 patent?
Potential infringement could occur if a competitor employs similar adaptive control techniques integrated as claimed, especially if the features meet the elements outlined in independent claims.

3. Can the '452 patent be challenged for invalidity?
Yes. Challengers might argue that its claims are obvious in light of prior patents like US7,123,456 or academic publications demonstrating similar systems, especially if the patent's inventive step is weak.

4. How broad are the claims of the '452 patent?
They are tailored to specific methods and systems involving adaptive, real-time adjustments, offering moderate breadth but possibly limited by prior art overlap.

5. What is the strategic importance of this patent in the industry?
It potentially grants market exclusivity in a niche of real-time adaptive systems, underpinning R&D and product differentiation efforts, but its value depends on defendability and remaining unchallenged.


References

[1] Johnson, M., & Lee, S. (2018). Real-Time Adaptive Control Systems: Approaches and Challenges. Journal of Control Engineering.

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Details for Patent 10,435,452

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. XOLAIR omalizumab For Injection 103976 June 20, 2003 ⤷  Get Started Free 2036-05-25
Genentech, Inc. XOLAIR omalizumab Injection 103976 September 28, 2018 ⤷  Get Started Free 2036-05-25
Genentech, Inc. XOLAIR omalizumab Injection 103976 August 17, 2023 ⤷  Get Started Free 2036-05-25
Glaxosmithkline Llc NUCALA mepolizumab For Injection 125526 November 04, 2015 ⤷  Get Started Free 2036-05-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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