Understanding the Scope and Claims of United States Patent 11,241,392
Introduction
United States Patent 11,241,392, titled "Compositions for treatment of attention deficit hyperactivity disorder (ADHD)," is a patent that delves into the development of pharmaceutical compositions aimed at treating ADHD. Here, we will analyze the scope, claims, and the broader patent landscape surrounding this invention.
Background on ADHD Treatments
ADHD is a neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity. Current treatments primarily target the dopamine and norepinephrine neural pathways, which are crucial for attention and impulse control[4].
Patent Overview
Publication Details
- Publication Number: US11241392B2
- Authority: United States
- Prior Art Date: This patent builds upon existing knowledge in the field of ADHD treatments, particularly focusing on sustained-release compositions.
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition, its components, and the method of administration.
- Claim 1: This claim often sets the broadest scope, describing the composition as including a specific active pharmaceutical agent, such as those affecting dopamine or norepinephrine pathways, and a sustained-release formulation.
- Dependent Claims: These claims narrow down the scope by specifying particular aspects of the composition, such as the type of sustained-release mechanism, the dosage form, and the specific active ingredients.
Claim Construction
The claims are constructed to ensure that the invention is distinguishable from prior art and to enable a person skilled in the art to make and use the invention. This aligns with the enablement requirement under ยง112 of the Patent Act, which mandates that the patent description be "in such full, clear, concise, and exact terms as to enable any person skilled in the art... to make and use the [invention]"[5].
Key Components of the Invention
Active Pharmaceutical Agents
The patent focuses on compositions that include active agents known to affect dopamine or norepinephrine pathways, which are key in treating ADHD. These agents are designed to provide a sustained release, ensuring a prolonged therapeutic effect.
Sustained-Release Formulation
The sustained-release formulation is a critical aspect of the invention. This formulation ensures that the active agents are released over an extended period, maintaining therapeutic levels in the bloodstream and enhancing patient compliance.
Patent Landscape
Prior Art and Related Patents
The patent landscape for ADHD treatments is extensive, with numerous patents covering various aspects of pharmaceutical compositions and delivery systems. The prior art keywords listed in the patent, such as "composition," "sustained release," and "core," indicate the areas where this patent innovates and differentiates itself from existing technologies[4].
Competitive Landscape
The competitive landscape in ADHD treatments is highly active, with multiple pharmaceutical companies developing new formulations and delivery systems. This patent positions itself within this landscape by offering a unique sustained-release composition that could potentially improve treatment outcomes and patient compliance.
Legal and Regulatory Considerations
Enablement Requirement
As seen in recent Supreme Court decisions, such as Amgen Inc. v. Sanofi, the enablement requirement is a critical aspect of patent validity. The patent must describe the invention in sufficient detail to enable a person skilled in the art to make and use it. This patent must adhere to this requirement to maintain its validity[5].
Inventorship and Ownership
Correctly determining inventorship is crucial for the enforceability of a patent. US patent law requires that only the true and only inventors be listed on the patent application. Ensuring accurate inventorship helps in avoiding legal challenges that could render the patent unenforceable[2].
Economic and Technological Impact
Market Demand
The demand for effective ADHD treatments is significant, given the prevalence of the disorder. A patent that offers a novel and improved treatment option can have a substantial economic impact by capturing a share of this market.
Technological Advancements
This patent contributes to the technological advancements in pharmaceutical formulations, particularly in the area of sustained-release systems. Such innovations can lead to better treatment outcomes and improved patient compliance, driving further research and development in the field.
Data and Statistics
Patent Allowance Rates
The probability of receiving a US patent, such as the one in question, can be influenced by various factors including the technology field, the size of the entity filing the patent, and the use of continuation procedures. For example, data from the USPTO shows that the allowance rates vary significantly across different technology fields and entity sizes[1].
Patent Claims and Scope Measurements
The USPTO's Patent Claims Research Dataset provides insights into the scope and claims of patents, including those related to pharmaceutical compositions. This dataset can help in understanding the trends and measurements of patent scope, which is crucial for assessing the novelty and non-obviousness of the invention[3].
Key Takeaways
- Novel Composition: The patent introduces a novel sustained-release composition for ADHD treatment, targeting dopamine and norepinephrine pathways.
- Enablement Requirement: The patent must meet the enablement requirement to ensure its validity.
- Competitive Landscape: The patent operates within a highly competitive landscape of ADHD treatments.
- Economic Impact: The patent has the potential for significant economic impact due to market demand for effective ADHD treatments.
- Technological Advancements: The patent contributes to advancements in pharmaceutical formulations, particularly in sustained-release systems.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of United States Patent 11,241,392?
A: The primary focus is on compositions for the treatment of attention deficit hyperactivity disorder (ADHD), specifically using sustained-release formulations.
Q: What are the key components of the invention described in the patent?
A: The key components include active pharmaceutical agents affecting dopamine or norepinephrine pathways and a sustained-release formulation.
Q: How does the patent landscape influence the validity and impact of this patent?
A: The patent landscape, including prior art and related patents, affects the novelty and non-obviousness of the invention. The competitive landscape also influences its market potential.
Q: What is the significance of the enablement requirement in this patent?
A: The enablement requirement ensures that the patent description is sufficient for a person skilled in the art to make and use the invention, which is crucial for the patent's validity.
Q: How can data from the USPTO's Patent Claims Research Dataset help in understanding this patent?
A: The dataset provides insights into patent scope and claims, helping to assess the novelty and non-obviousness of the invention and understand trends in patent measurements.
Cited Sources:
- Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. The Yale Journal of Law & Technology.
- Gattari, et al. (n.d.). Determining Inventorship for US Patent Applications. Oregon State University.
- USPTO. (2017). Patent Claims Research Dataset. USPTO Economic Research.
- US11241392B2. (n.d.). Compositions for treatment of attention deficit hyperactivity disorder. Google Patents.
- Supreme Court of the United States. (2023). Amgen Inc. v. Sanofi. Supreme Court Opinions.
