Understanding the Scope and Claims of United States Patent 10,896,751
Introduction
United States Patent 10,896,751, titled "Storage and Dispensing Devices for Administration of Oral Transmucosal Dosage Forms," is a significant patent in the field of pharmaceutical delivery systems. This patent, issued to innovators in the healthcare industry, outlines novel designs and methods for administering small volume drug dosage forms via the oral mucosa.
Background and Context
The patent is part of a series of continuations and divisions of earlier patent applications, dating back to 2009. This indicates a long-term development and refinement process, reflecting the complexity and innovation involved in the invention[4].
Field of the Invention
The patent pertains to handheld and portable drug dispensing devices, systems, and methods specifically designed for oral transmucosal administration. This field is crucial for delivering medications directly to the oral mucosa, bypassing traditional gastrointestinal absorption routes and potentially enhancing bioavailability and efficacy[4].
Key Features of the Invention
The patent describes several key features of the dispensing devices and systems:
Lock-Out Feature
The device includes a lock-out feature that prevents the removal of a Single Dose Assembly (SDA) during a specified lock-out time, ensuring controlled and safe administration[4].
Dose Counting Feature
A dose counting mechanism is integrated to track the number of doses dispensed, which is vital for patient compliance and safety[4].
Patient Identification Feature
The device may include a patient identification feature, such as RFID, to ensure that the medication is administered to the correct patient[4].
Child Resistant Feature
The design incorporates child-resistant features to prevent accidental ingestion by children[4].
Detailed Description of the Invention
Single Dose Assembly (SDA)
Each SDA consists of two case halves housing the drug dosage form, a label designed for child resistance, a pusher, and a bridge feature that breaks away as the pusher is advanced to deliver the drug dosage form to the oral mucosal membrane[4].
Drug Dispensing Devices and Systems
The patent details various configurations of drug dispensing devices and systems, including handheld devices and methods for their use. These devices are designed to dispense small volume dosage forms efficiently and safely[4].
Patent Claims
The patent includes multiple claims that define the scope of the invention. These claims are critical as they determine the legal boundaries of what is protected under the patent.
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. For example, Claim 1 might describe the overall device and its primary components, while subsequent independent claims might detail specific features or methods of use[4].
Dependent Claims
Dependent claims build upon independent claims, adding additional limitations or features. These claims help to narrow the scope and provide further specificity to the invention[4].
Patent Scope Analysis
The scope of a patent is a critical aspect that determines its breadth and validity. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Claim Length and Count
Studies suggest that the length and count of independent claims can be metrics for measuring patent scope. Patents with narrower claims tend to have a more streamlined examination process and are less likely to face challenges regarding their validity[3].
Patent Landscape
The patent landscape for drug dispensing devices, particularly those focused on oral transmucosal administration, is highly competitive and innovative. Several companies and researchers are actively developing new technologies to improve drug delivery.
Competing Patents
Other patents in this field may cover similar or complementary technologies, such as different mechanisms for drug delivery or additional safety features. Understanding these competing patents is essential for navigating the intellectual property landscape and avoiding potential infringement issues[1].
Importance of Correct Inventorship
The determination of inventorship is a crucial aspect of patent law. The USPTO requires that only the true and only inventors be listed on the patent application. Incorrect or incomplete identification of inventors can lead to the patent being deemed invalid or unenforceable[5].
Practical Implications
For businesses and researchers working in this field, understanding the scope and claims of this patent is vital. It helps in:
Avoiding Infringement
Knowing the specific claims and features protected under this patent can help in designing new products that do not infringe on existing intellectual property rights.
Licensing and Collaboration
The patent's scope can influence licensing agreements and collaborative research efforts. Companies may need to negotiate licenses or partnerships to use the protected technology.
Innovation and Improvement
Understanding the existing technology can inspire further innovation and improvement. Researchers can build upon the existing designs and methods to create even more effective drug delivery systems.
Key Takeaways
- Innovative Design: The patent introduces novel features such as lock-out, dose counting, and patient identification, enhancing the safety and efficacy of oral transmucosal drug delivery.
- Patent Scope: The scope of the patent is defined by its claims, with narrower claims generally associated with a higher probability of grant and shorter examination process.
- Competitive Landscape: The patent landscape for drug dispensing devices is highly competitive, with multiple patents covering various aspects of drug delivery.
- Inventorship: Correct determination of inventorship is crucial to ensure the patent's validity and enforceability.
- Practical Implications: Understanding the patent's scope and claims is essential for avoiding infringement, licensing, and further innovation.
FAQs
Q1: What is the primary focus of United States Patent 10,896,751?
The primary focus is on handheld and portable drug dispensing devices and systems for oral transmucosal administration of small volume drug dosage forms.
Q2: What are some key features of the dispensing devices described in the patent?
Key features include a lock-out feature, dose counting mechanism, patient identification feature, and child-resistant design.
Q3: How important is correct inventorship in patent applications?
Correct inventorship is crucial as incorrect or incomplete identification can lead to the patent being deemed invalid or unenforceable.
Q4: What metrics can be used to measure the scope of a patent?
Metrics such as independent claim length and independent claim count can be used to measure patent scope and predict the likelihood of grant and examination duration[3].
Q5: Why is understanding the patent landscape important for businesses and researchers?
Understanding the patent landscape helps in avoiding infringement, negotiating licenses, and driving further innovation by building upon existing technologies.
Sources
- USPTO Search: Search for patents - USPTO.
- USA.gov: U.S. Patent and Trademark Office (USPTO) | USAGov.
- SSRN: Patent Claims and Patent Scope.
- Justia Patents: US Patent for Storage and dispensing devices for administration of ...
- Oregon State University: Determining Inventorship for US Patent Applications.
