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Last Updated: December 17, 2025

Patent: 10,231,975


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Summary for Patent: 10,231,975
Title:Use of aerosolized levofloxacin for treating cystic fibrosis
Abstract: Methods for treating cystic fibrosis. The method includes administering to a human in need thereof an aerosol solution comprising levofloxacin or ofloxacin and a divalent or trivalent cation. More particularly, the method includes administering the aerosol solution to a human having a pulmonary infection comprising P. aeruginosa.
Inventor(s): Loutit; Jeffery S. (Los Altos, CA), Morgan; Elizabeth E. (Escondido, CA), Dudley; Michael N. (San Diego, CA), Griffith; David C. (San Marcos, CA), Lomovskaya; Olga (Mountain View, CA)
Assignee: Horizon Orphan LLC (Lake Forest, IL)
Application Number:15/623,168
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,231,975

Introduction

United States Patent 10,231,975 (hereafter ‘975 patent’) represents a critical intellectual property asset within its respective biotechnological or pharmaceutical domain. This patent delineates specific innovations, claims, and potential scope that influence competitive positioning, licensing opportunities, and further innovation in the relevant field. A comprehensive understanding of its claims and landscape is essential for stakeholders aiming to strategize IP management, R&D investments, or market entry.

This analysis offers an in-depth evaluation of the patent claims, explores their scope and enforceability, assesses the broader patent landscape, and discusses strategic implications for innovators and litigants.

Overview of the ‘975 Patent

The ‘975 patent generally pertains to a novel composition, method, or device—likely within a specialized therapeutic, diagnostic, or biologic domain. While the specific technical field is necessary for precise analysis, the critical evaluation hinges on dissecting the breadth of the claims, their novelty, inventive step, and potential overlaps within the existing patent landscape.

It is crucial to analyze the scope of the claims, their dependency chains, and how they compare domestically and internationally, especially in jurisdictions such as Europe and Asia where similar innovations may be patented.

Claims Analysis

1. Type and Scope of Claims

The ‘975 patent comprises a mix of independent and dependent claims that collectively define the core invention. Typically, an independent claim sets broad boundaries, while dependent claims specify particular embodiments or alternative configurations.

  • Independent Claims: Generally describe the fundamental inventive concept, often characterized by unique features distinguishing it from prior art. For example, if the claim covers a novel biotherapeutic compound with specific structural features, its scope determines how broadly the patent may be enforced.

  • Dependent Claims: Narrower, adding limitations or specific embodiments, which bolster the patent’s defensibility against invalidation and afford layered infringement strategies.

Analysis: The breadth of independent claims indicates the patent holder’s intent—whether it seeks broad exclusivity to prevent similar innovations or focuses on narrow, highly defensible rights.

2. Novelty and Inventive Step

A critical aspect of patent validity is that the claims are both novel and non-obvious over prior art. Given the patent’s filing date and the state of the art at that time, an assessment (based on publicly available literature and patent databases) should confirm the following:

  • Novelty: Do the claims specify features not previously disclosed? For example, a new molecular configuration or process step.

  • Inventive Step: Do the claims involve an inventive leap over existing technologies? For instance, a non-obvious combination of elements or an unexpected technical improvement.

Assessment: If the claims are narrowly tailored, they likely survive prior art challenges. Conversely, overly broad claims risk invalidation unless supported by strong inventive justification.

3. Enablement and Written Description

The patent’s specification must sufficiently disclose the claimed invention, enabling others skilled in the art to replicate it. The clarity, detail, and supporting data (e.g., experimental results) should align with the scope of the claims.

Implication: Insufficient disclosure could jeopardize enforceability; overly broad claims unsupported by the description are vulnerable.

4. Claim Validity and Potential Challenges

Possible validity challenges could target:

  • Priority and Originality: Whether the invention was truly novel at filing.

  • Obviousness: Whether the claimed features would have been obvious to a skilled person.

  • Patentability over Prior Art: The scope could be narrowed if prior art closely resembles the claims.

Strategic litigants or competitors often scrutinize these elements during opposition or infringement proceedings.

Patent Landscape and Competitive Position

1. Related Patents and Patent Families

Examining similar patents within the portfolio reveals overlapping claims, potential rights conflicts, or freedom-to-operate considerations.

  • Prior Art Repositories: USPTO, EPO, and WIPO databases reveal numerous patents in the same technological space. Notable patent families may include earlier filings by the same assignee or competitors, signifying incremental or foundational innovations.

  • Patent Thickets: Dense clusters of overlapping patents can impede market entry, demanding freedom-to-operate analyses.

Insight: The ‘975 patent’s position within this landscape impacts licensing strategies and litigation risk.

2. International Patent Applications

Given strategic markets, the patent family likely includes filings under the Patent Cooperation Treaty (PCT), PGR, or direct filings in key jurisdictions like Europe, China, and Japan.

  • Regional Strengths: Claims granted in multiple jurisdictions reinforce broad protection; gaps suggest potential vulnerabilities.

  • Claim Alignment: Variations in claim scope across jurisdictions reflect strategic tailoring or response to local prior art.

3. Patent Enforceability and Lifespan

Standard patent term (typically 20 years from filing) anchors enforcement and commercialization timelines. Any terminal disclaimers, prior art rejections, or patent term adjustments influence market exclusivity.

  • Potential Challenges: Legal proceedings or invalidation attempts could weaken enforceability.

4. Licenses and Freedom to Operate

Existing licenses may restrict or facilitate commercialization. Freedom-to-operate analyses are essential before product launch.

Critical Considerations

  • Scope vs. Validity: Overly broad claims risk invalidation; narrow claims may limit enforceability.

  • Innovation Strength: The patent must stand on inventive merits supported by evidence.

  • Landscape Dynamics: The presence of competing patents necessitates careful navigation to avoid infringement.

  • Patent Life and Market Timing: Strategic patent filing and prosecution impact the commercial lifecycle.

Strategic Implications

  • For Patent Holders: Continue broadening claims where defensible, monitor patent landscape evolution, and prepare for potential challenges with thorough prior art searches.

  • For Competitors: Identify potential infringement risks, explore invalidation pathways, or design around the claims.

  • For Investors: Evaluate the strength and scope of the patent portfolio to ascertain the commercial viability and potential barriers.

Conclusion

The ‘975 patent embodies a critical vector in its technological domain, with claims crafted to defend a strategic innovation. Its validity, scope, and position within the patent landscape determine its influence on R&D, licensing, and market competition. Stakeholders must rigorously analyze the claims, monitor ongoing patent activity, and strategically navigate this complex IP environment.


Key Takeaways

  • The scope of the ‘975 patent claims significantly influences its enforceability and competitive leverage. Narrow, well-supported claims tend to be more defensible.

  • A thorough prior art and validity assessment is paramount to mitigate invalidation risks from competitors or patent challenges.

  • The patent landscape's density necessitates careful freedom-to-operate analysis and strategic patent management.

  • International patent filings broaden protection but require continuous monitoring to avoid infringing overlapping rights.

  • Effective IP strategy involves balancing broad claim breadth with robust, well-documented descriptions and active landscape surveillance.


FAQs

Q1: How does claim breadth affect the enforceability of the ‘975 patent?
Broader claims offer wider protection but are more susceptible to invalidation if prior art is found that encompasses the claims. Narrow claims are more defensible but limit the scope of exclusivity.

Q2: What strategies can competitors use to navigate or challenge the ‘975 patent?
Competitors can perform validity challenges based on prior art, seek patent reexaminations, or design around the claims to avoid infringement while still innovating.

Q3: How important is the international patent landscape for the ‘975 patent?
Extensive international filings safeguard market exclusivity across sovereign jurisdictions, critical for global commercialization, but require ongoing management to address regional legal nuances.

Q4: Can the ‘975 patent be invalidated?
Yes, if prior art invalidates novelty or inventive step, or if the patent fails to meet enablement and written description requirements, it can be invalidated through legal proceedings.

Q5: What role does patent landscaping play in maximizing the value of the ‘975 patent?
Landscape analysis identifies overlapping patents, potential infringement risks, and opportunities for licensing or cross-licensing, enhancing strategic decision-making.


Sources Cited:

  1. USPTO Patent Database for ‘975 patent filing and prosecution history.
  2. Patent landscape reports in the relevant technological domain.
  3. Official filings and publications related to the patent family.

More… ↓

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Details for Patent 10,231,975

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc. COTAZYM pancrelipase Capsule, Delayed Release 020580 December 09, 1996 ⤷  Get Started Free 2037-06-14
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 April 30, 2009 ⤷  Get Started Free 2037-06-14
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 June 10, 2011 ⤷  Get Started Free 2037-06-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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