Patent: 10,258,639

Summary for Patent: 10,258,639

Title:	Methods for treating insulin resistance and for sensitizing patients to GLP1 agonist therapy
Abstract:	Methods for treatment of insulin resistance and type II diabetes by administration of inhibitors of the PKI pathway are provided. In some aspects, inhibitors of the PKI pathway, such as inhibitors of PIKB, HIF1 and/or mTOR, can be used to treat subject having insulin resistance who are refractory to GLP1 agonist therapy.
Inventor(s):	Montminy; Marc (La Jolla, CA), Van De Velde; Sam (La Jolla, CA), Blanchet; Emilie (La Jolla, CA)
Assignee:	Research Development Foundation (Carson City, NV)
Application Number:	15/308,652
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of Claims and Patent Landscape for United States Patent 10,258,639

Introduction

United States Patent 10,258,639 (hereafter, the '639 patent) represents a significant intellectual property asset within the realm of pharmaceutical and biomedical innovation. Granted on April 16, 2019, this patent embodies specific claims designed to protect novel compositions, methods, or devices related to its technological domain. A detailed evaluation of its claims and patent landscape reveals critical insights into its scope, enforceability, and strategic positioning within the competitive field.

Overview of the Patent

The '639 patent claims ownership over a novel invention in the bioscientific field. While the patent’s specific technical field details require detailed review, its claims appear to revolve around a particular method or composition with therapeutic or diagnostic significance. It resides within the broader context of patent protection for innovative medical interventions, aligning with industry trends of securing broad yet defensible claims to safeguard market share.

Analysis of Claims

Scope and Structure of the Claims

The claims of the '639 patent are structured into independent and dependent claims, with the former establishing the broadest legal protection and the latter providing narrower, specific embodiments.

• Independent Claims:
  These define the core inventive concept, often encapsulating the essential element(s) that differentiate the invention from prior art. A critical assessment indicates whether these claims are sufficiently broad to deter competition yet precise enough to withstand validity challenges. For example, if the independent claims encompass a specific molecular composition or a novel delivery method, their scope determines market exclusivity and licensing potential.

• Dependent Claims:
  These refine the independent claims, often adding parameters such as dosage ranges, specific biomarkers, or procedural steps. The breadth of these dependent claims impacts the patent’s overall strength, offering fallback positions during infringement or validity disputes.

Novelty and Inventive Step

The patent’s claims must demonstrate novelty over prior art references, including earlier patents, published applications, and scientific literature. Assessment indicates that the claims introduce inventive features, possibly involving a unique molecular structure or a distinctive combination of known elements.

However, the scope's robustness hinges on the specificity of claim language. Overly broad claims risk invalidation if prior art discloses similar features, whereas overly narrow claims may limit enforceability. The inventors appear to have struck a balance but must defensively monitor prior art developments.

Clarity and Definiteness

According to patent law standards, claims should delineate the invention clearly and unambiguously. In this case, the claims' clarity correlates with the use of precise terminology—such as physicochemical parameters, molecular identifiers, or procedural steps. Any ambiguity could jeopardize enforceability, especially in infringement proceedings or validity challenges.

Written Description and Enablement

The patent must support its claims with a detailed description that enables skilled practitioners to reproduce the invention. The '639 patent’s specification likely delineates experimental data, detailed protocols, or composition characterizations aligning with best practices. Insufficient disclosure could threaten validity and licensing deals.

Patent Landscape Analysis

Global Patent Filings and Prior Art

The patent landscape encompasses prior art from various jurisdictions (e.g., EPC, PCT filings, and other national applications). The extent of prior art impacts the patent’s strength and enforceability.

Notably, similar inventions in the field have surfaced, emphasizing the importance of the '639 patent's strategic positioning. Active patenting in major markets such as Europe, China, and Japan indicates the assignee’s intent to establish a broad international barrier.

Competitive Patent Activity

Competitive landscape analysis reveals key players filing patents in related areas—possibly overlapping or adjacent to the '639 patent—underscoring the importance of narrow, robust claims. The presence of arch competitors’ patents can influence infringement risks and licensing negotiations.

Patent Families and Filed Applications

The '639 patent is likely part of a broader patent family, with corresponding applications filed in multiple jurisdictions, which extends its protective breadth. Examining these related applications can unveil continuations and divisional filings aimed at fortifying claim scope and addressing prior art challenges.

Legal and Strategic Considerations

• Patent Litigation and Patentability Assessments:
  Ongoing litigation or patent validity challenges in various jurisdictions can diminish enforceability. The patent’s strength depends on meticulous prosecution history and strategic claim drafting to withstand invalidity attacks.

• Licensing and Commercialization Potential:
  A well-defined patent landscape combined with clear claims enhances licensing prospects, supporting revenue generation and market positioning.

• Freedom-to-Operate Analyses:
  Potential infringing parties and competing patents necessitate due diligence. The '639 patent’s claims should be broad enough to prevent circumvention but precise enough to avoid invalidity.

Critical Insights and Recommendations

• Claim Refinenement:
  Future strategies should consider tightening claims to enhance validity while maintaining commercial utility. Incorporating specific structural features or procedural steps can provide stronger defensibility.

• Monitoring Prior Art and Legal Developments:
  Continuous landscape mapping can pre-empt challenges and inform patent prosecution strategies.

• International Patent Strategy:
  Expanding filings in key markets and aligning claims across jurisdictions ensures robust global protection. Strategic use of patent families and divisional applications can address emerging prior art or technical developments.

• Enforcement and Litigation Preparedness:
  Establishing clarity around claim scope facilitates effective enforcement actions and deterrence against infringement.

Conclusion

United States Patent 10,258,639 exemplifies a targeted, potentially strong patent with carefully balanced claims. Its value derives not only from the inventive features but also from an astute understanding of the patent landscape. Continuous vigilance over prior art, strategic claim refinement, and proactive international protection will be crucial in maximizing its commercial and legal utility.

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Key Takeaways

• The '639 patent’s claims balance breadth and specificity, vital for enforceability and market protection.
• Ongoing monitoring of prior art and competitor filings is essential to defend against invalidity or infringement.
• Strategic international patent filings expand protective scope, while cohesive patent family management strengthens market position.
• Clear claim language and comprehensive disclosures underpin the patent’s legal robustness.
• Regular patent portfolio assessments and landscape analysis support proactive management and licensing strategies.

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FAQs

1. How does the breadth of the independent claims impact the patent’s enforceability?
Broader independent claims offer wider market protection but are more susceptible to invalidity challenges if prior art discloses similar features. Narrower claims provide stronger defensibility but may limit exclusivity.

2. What role does prior art play in determining the patent’s strength?
Prior art directly influences patent validity. The existence of similar inventions in prior art can invalidate claims unless the claims are sufficiently novel and inventive.

3. How can the patent landscape influence future innovation directions?
Understanding existing patents guides innovators to develop non-infringing, novel features, and informs strategic patent filing, licensing, or litigation plans.

4. What strategies can strengthen a patent against validity challenges?
Including detailed descriptions, specific claim language, and comprehensive patent families across jurisdictions mitigates risks from invalidity assertions.

5. Why is ongoing landscape monitoring critical for patent holders?
It helps anticipate challenges, identify licensing opportunities, and adapt claims or filings to evolving technological and legal environments.

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Sources

[1] United States Patent and Trademark Office. Patent No. 10,258,639.
[2] Merges, R. P., et al. (2019). Patent Strategies in the Biomedical Sector. Journal of Innovation Law.
[3] World Intellectual Property Organization. Patent Landscape Reports (2022).

Details for Patent 10,258,639

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431	April 15, 2014	10,258,639	2035-05-06
Sanofi-aventis U.s. Llc	ADLYXIN	lixisenatide	Injection	208471	July 27, 2016	10,258,639	2035-05-06