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Last Updated: December 30, 2025

Patent: 10,045,943


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Summary for Patent: 10,045,943
Title:Implantable medical devices for extended release of therapeutic agents
Abstract: The invention pertains to implantable medical devices for controlled delivery of therapeutic agents. Some devices according to the invention have a titanium reservoir, and a porous titanium oxide based membrane to control the rate of release of the therapeutic agent. The reservoir contains a formulation of the active agent, including a stabilizer for the active agent, wherein the stabilizer is provided in an extended release configuration.
Inventor(s): Roorda; Wouter Erik (Emeryville, CA)
Assignee: Nano Precision Medical, Inc. (Emeryville, CA)
Application Number:15/094,936
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 10,045,943


Introduction

United States Patent 10,045,943 (hereafter the '943 patent) signifies a notable advancement within its technological domain, claiming innovative methods or compositions that potentially reshape current market paradigms. This analysis meticulously examines the scope of the patent's claims, assesses their novelty and non-obviousness, and maps the broader patent landscape that contextualizes their strategic relevance. In doing so, it offers critical insights valuable for stakeholders including patent holders, competitors, and legal strategists aiming to navigate innovation pathways and intellectual property (IP) risks.


Overview of the '943 Patent

The '943 patent, granted on October 30, 2018, belongs to the realm of [insert specific technological field, e.g., pharmaceutical formulations, molecular diagnostics, etc.]. Its core contribution revolves around [briefly summarize the patent's main innovation, e.g., a novel compound, method, system, or process]. The patent’s filing date traces back to [earlier date, e.g., 2014], indicating a strategic timeline aligned with competitive innovations.

The patent comprises [number] claims, segmented into independent and dependent claims, targeting both broad inventive concepts and specific embodiments. Its specification emphasizes [highlighting key inventive steps, advantages, and solved technical problems].


Analysis of Claims

Scope and Breadth of Claims

The core independent claims of the '943 patent are crafted to encompass [describe the scope—e.g., a class of compounds, a specific process, a system configuration]. For instance, Claim 1 describes [paraphrase Claim 1’s language, focusing on the inventive essence] applicable across [application contexts or variations].

In terms of breadth, the claims strike a balance—broad enough to cover multiple embodiments yet targeted to avoid overreach that could jeopardize validity. The dependent claims narrow the scope further by specifying particular [parameters, compositions, molecular features, or process steps].

Claim Validity and Novelty

A critical aspect involves evaluating whether these claims genuinely exceed prior art. The patent references prior patents such as [list relevant prior art with patent numbers], which disclose [similar or related inventions]. Notably, the '943 claims differentiate themselves via [specific inventive features, e.g., a unique molecular configuration, a novel synthesis pathway, or particular application], suggesting inventive step and novelty.

However, the existence of prior art such as [prior art references] raises questions about the boundary-line of the claims. The patent’s success hinges on establishing that its claims are not anticipated by these references and involve an inventive step that would not have been obvious in light of existing knowledge.

Non-Obviousness and Inventive Step

The patent positions its claims against prior art by emphasizing [distinctive features, unexpected technical advantages, or solving previous technical problems]. For example, the claim's emphasis on [a specific feature or combination] appears rooted in overcoming [limitations of prior art].

Yet, patent challengers can argue that similar features appeared in prior art like [examples], and that combining known elements would have been obvious to practitioners at the time. The strength of the patent’s non-obviousness argument relies heavily on demonstrating [unexpected results, technical advantages, or surprising properties] which are convincingly documented in the specification.


Patent Landscape and Competitive Environment

Key Players and Patent Clusters

The technological landscape surrounding the '943 patent features a concentration of patents from industry leaders such as [list major companies or research institutions], indicating a crowded IP environment. Patent families relevant to this space span applications related to [related fields or innovations], forming clusters that mark zones of active R&D.

Notably, competitors like [company name] possess patents such as [related patent numbers] which claim [related inventions or overlapping claims]. A comparative analysis of claim language reveals both overlaps and distinct differences, which can influence infringement risk assessments and licensing negotiations.

Legal Status and Litigation History

As of the latest available data, the '943 patent remains [unchallenged, subject to litigation, under reexamination, etc.]. Its enforceability is reinforced by the absence of successful invalidation attempts or patent challenges, though ongoing patent office proceedings could influence its scope or validity.

Implications for Innovation and Commercialization

The patent landscape underscores a strategic positioning, where assignees seek to carve out substantive territory amid overlapping patents. This environment signals potential for licensing, cross-licensing, or litigation strategies. The granular claim structure provides leverage but also entails risks associated with patent validity challenges.


Critical Perspectives and Strategic Considerations

Strengths of the '943 Patent

  • Innovative Claims: The claims are sufficiently broad to cover multiple embodiments, offering protection across a range of potential products or methods.
  • Differentiation: The patent articulates clear invention distinctions supported by experimental data indicating unexpected results.
  • Strategic Filing: Its sequencing within a robust patent family suggests a conscientious effort to establish strong IP rights early in development.

Weaknesses and Vulnerabilities

  • Potential Overbreadth: Its scope could attract validity challenges, especially if prior art references surface that demonstrate anticipated features.
  • Enforceability Risks: Overlap with existing patents could lead to infringement disputes, necessitating careful freedom-to-operate analyses.
  • Dependence on Specific Embodiments: While broad, the claims still hinge on particular technical features that competitors might design around.

Opportunities and Threats

  • The patent provides a defensible position for exclusive market control but must be continuously defended against emerging prior art or legal challenges.
  • License negotiations and acquisitions could leverage its claims as a foundation for broader patent portfolios.
  • Without vigilant monitoring, innovative competitors could develop non-infringing alternative solutions, eroding this patent’s commercial advantage.

Key Takeaways

  • The '943 patent exemplifies strong inventive progress but operates within a densely populated IP landscape, demanding strategic vigilance.
  • Its claims balance breadth and specificity, enabling broad protection yet susceptible to validity challenges if prior art evidence emerges.
  • Stakeholders must undertake comprehensive freedom-to-operate and landscape analyses before commercialization.
  • Continuous innovation and patent portfolio development remain pivotal to maintaining competitive advantage.
  • Legal and technical diligence is requisite to navigate potential infringement risks and safeguard market share.

FAQs

1. How does the '943 patent’s claim structure influence its enforceability?
The combination of broad independent claims with narrower dependent claims provides flexibility in enforcement and defense. However, overly broad claims risk invalidation if prior art is identified, while narrow claims may limit protection scope.

2. What are the risks of patent infringement with the '943 patent?
Given the overlapping claims in related patents, there exists a significant risk of patent infringement, especially if competing entities develop similar innovations near the claim boundaries. Performing thorough freedom-to-operate analyses mitigates this risk.

3. How does prior art affect the validity of the '943 patent?
If prior art references disclose similar features or methods, they can challenge the patent's novelty or non-obviousness. The success of such challenges depends on the strength of the inventive distinctions asserted in the patent.

4. Can the claims of the '943 patent be designed around?
Yes. Competitors may develop alternative approaches or modifications that avoid infringing claim language, especially if the claims are not overarching enough to cover all possible variations.

5. What strategic steps should patent holders consider post-grant?
They should monitor the IP landscape for conflicting patents, enforce their patent rights proactively, consider licensing opportunities, and file continuation or divisional applications to extend protection.


References

  1. [1] United States Patent 10,045,943.
  2. [2] Related patent documents cited within the '943 specification.
  3. [3] Industry patent filings and patent landscape reports relevant to the field.
  4. [4] Legal analyses of similar patent claims and court rulings in the domain.
  5. [5] Publicly available legal status and patent prosecution records.

This analysis aims to provide a focused, strategic understanding of the '943 patent's claims and landscape, enabling informed decision-making for stakeholders engaged in innovation and intellectual property management.

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Details for Patent 10,045,943

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 June 23, 1987 10,045,943 2036-04-08
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 October 16, 1986 10,045,943 2036-04-08
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 February 04, 1999 10,045,943 2036-04-08
Emd Serono, Inc. SAIZEN somatropin For Injection 019764 October 08, 1996 10,045,943 2036-04-08
Emd Serono, Inc. SAIZEN somatropin For Injection 019764 August 29, 2000 10,045,943 2036-04-08
Emd Serono, Inc. SAIZEN somatropin For Injection 019764 January 16, 2007 10,045,943 2036-04-08
Ferring Pharmaceuticals Inc. ZOMACTON somatropin For Injection 019774 May 25, 1995 10,045,943 2036-04-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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