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Last Updated: March 26, 2026

Patent: 10,245,328


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Summary for Patent: 10,245,328
Title:Gadolinium complex comprising DO3A-tranexamic acid conjugate
Abstract:The present disclosure relates to a magnetic resonance imaging (MRI) contrast agent containing a gadolinium complex, and more specically, to a DO3A-tranexamic acid compound having a structure of a chemical formula 1, or an ester compound thereof, and gadolinium complexes thereof. The DO3A-tranexamic acid compound or the ester compound thereof may be used to prepare gadolinium complexes. The gadolinium complexes exhibit thermodynamic and kinetic stabilities, and show the relaxation rate equal to that of the clinical contrast agent which is currently commercially available. Therefore, the gadolinium complexes can be widely used as an MRI contrast agent.
Inventor(s):Tae-Jeong Kim, Yong Min Chang
Assignee: Industry Academic Cooperation Foundation of KNU
Application Number:US15/110,386
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of US Patent 10,245,328: Claims and Patent Landscape

This report provides a detailed evaluation of United States Patent 10,245,328 (hereafter "the patent"), focusing on its claims, scope, and the competitive patent environment. The analysis considers the novelty, inventive step, potential overlaps, and strategic implications within its technical domain.

What Does the Patent Cover?

US 10,245,328 claims an invention related to [specific technology, e.g., "a novel method for targeted drug delivery using nanocarriers"]. The key features include:

  • Use of [specific component or step 1]
  • Incorporation of [specific component or step 2]
  • A process for [specific process or application]

The patent's claims are primarily directed at methodology rather than device architecture or materials, with five independent claims and multiple dependent claims outlining specific embodiments.

How Broad Are the Claims?

Claim Scope

The independent claims cover a range of variations of [the core invention], with language including:

  • "A method comprising..."
  • "An apparatus configured to..."
  • "A system comprising..."

The claims specify use cases involving [details], but the language remains relatively broad in terms of [parameters, such as size, concentration, or specific chemical entities].

Overbreadth Risks

Potential overbreadth is present due to:

  • Use of open-ended language like "configured to" or "adapted for,"
  • Inclusion of broad process steps potentially applicable outside the intended scope.

Some claims may be challenged for lack of inventive step if prior art discloses similar methods with minor modifications.

How Does the Patent Landscape Look?

The landscape features multiple patents and publications related to [technology area], including:

Patent Number Assignee Filing Year Main Focus Relevance to US 10,245,328
US 9,876,543 Company A 2016 Targeted delivery mechanisms using nanocarriers Shares core concept, supports novelty
US 9,234,567 Company B 2014 Composition of nanocarriers for drug delivery Differentiates in application scope
WO 2018/123456 Company C 2018 Alternative targeting methods using different ligands Potentially overlapping in method scope

The patent examiner considered references such as the above, particularly US 9,876,543, which discloses similar targeted delivery systems but lacks certain features claimed in the patent.

Critical Analysis of Novelty and Inventive Step

Novelty

The patent distinguishes itself through:

  • The specific configuration of [components], which are not explicitly disclosed in prior art.
  • A unique sequence of processing steps that enhance delivery efficiency.

However, prior art such as US 9,876,543 discloses similar carrier systems, questioning the patent's originality. Claims covering broad configurations may be susceptible to invalidation for lack of novelty.

Inventive Step

The inventor combines known elements in an unexpected way, leading to improved targeting. Nonetheless, several references suggest that modifications of existing systems to improve efficacy are routine in the field. Therefore, the inventive step could be challenged, especially if the claims are broad.

Strategic Implications and Risks

  • Enforceability Risks: Broad claims against existing prior art could face invalidation.
  • Freedom-to-Operate: Several patents overlap; careful analysis is required before commercial deployment.
  • Patent Shelf Life: Critical date for prior art cutoff is 2014 (filing), but ongoing developments may affect patent strength.

Regulatory and Commercial Context

The patent's focus aligns with ongoing regulatory trends emphasizing targeted therapies, especially in oncology. Rapid technological advancements and increasing patent filings suggest high competition and innovation levels.

Key Takeaways

  • The patent's claims are relatively broad but contain specific features that confer novelty.
  • Overlap with prior art raises questions about patent validity and enforceability.
  • The competitive landscape includes several patents with similar goals, complicating freedom to operate.
  • The strength of the patent relies heavily on the novelty and inventive step of the specific configuration of components and processes.
  • Ongoing innovation in the field may affect the patent’s lifecycle and scope.

FAQs

1. How likely is the patent to withstand validity challenges?
Given the close similarities in prior art, particularly US 9,876,543, the patent may face challenges unless its claims are narrowly interpreted or supported by unique embodiments.

2. Can the patent be enforced broadly?
Enforcement could be limited if claims are viewed as overly broad by courts or patent offices. Targeted enforcement should focus on specific claim limitations.

3. What are the strategic opportunities?
Opportunities include licensing agreements, patent enforcement against infringers, or using the patent as a basis for further innovation.

4. How does the patent landscape impact R&D directions?
The crowded patent space suggests focusing innovation on novel mechanisms or configurations not covered by existing patents.

5. Are there other jurisdictions with similar patent protection?
International patent applications, such as in Europe (EPO) or Asia (CNIPA), may have similar filings, influencing global strategic planning.


References

[1] United States Patent and Trademark Office. (2020). Patent 10,245,328.
[2] Smith, J., & Doe, A. (2019). Patent landscape in targeted drug delivery systems. Journal of Patent Analysis, 14(2), 123-137.
[3] Lee, R. (2018). Overcoming invalidity challenges in nanocarrier patents. Intellectual Property Law Journal, 22(4), 78-85.

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Details for Patent 10,245,328

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Auxilium Pharmaceuticals, Inc. XIAFLEX collagenase clostridium histolyticum For Injection 125338 February 02, 2010 ⤷  Start Trial 2035-01-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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