Analyzing the Scope and Claims of United States Patent 10,441,194: Ingestible Event Marker Systems
Introduction
The United States Patent 10,441,194, titled "Ingestible Event Marker Systems," is a significant innovation in the field of medical technology. This patent, granted to Proteus Digital Health, Inc., introduces a novel system for tracking the ingestion of medications or other events within the body. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Overview of the Patent
Inventors and Assignees
The patent was invented by a team of researchers and engineers at Proteus Digital Health, Inc., and assigned to the same company. This assignment highlights the company's commitment to developing and commercializing innovative healthcare technologies[4].
Publication and Grant Details
The patent was published on October 8, 2019, and granted on October 8, 2019. The application number is US14/341,636, and it was filed on July 25, 2014[4].
Scope of the Patent
Ingestible Event Markers (IEMs)
The patent describes an ingestible event marker system that includes an ingestible event marker (IEM) and a personal signal receiver. The IEM is designed to be ingested and, upon contact with bodily fluids, generates a signal that is transmitted to the receiver. This signal indicates the time and event of ingestion, providing real-time monitoring of medication adherence or other ingestible events[4].
Components and Functionality
- IEM: The ingestible event marker is a small, ingestible device that contains a sensor and a communication module. Upon ingestion, it comes into contact with bodily fluids, triggering the generation of a signal.
- Personal Signal Receiver: This device receives the signal from the IEM and can be a wearable device, a smartphone, or any other compatible receiver.
- Data Transmission: The signal is transmitted wirelessly to the receiver, which can then forward the data to healthcare providers or other monitoring systems[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover various aspects of the system, including:
- The ingestible event marker itself, with its sensor and communication module.
- The personal signal receiver and its functionality.
- The method of generating and transmitting the signal upon ingestion[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the materials used in the IEM, the type of signals generated, and the methods of data transmission. These claims help to narrow down the scope and ensure that the invention is clearly defined and distinguishable from prior art[4].
Patent Landscape
Prior Art and Novelty
The patent landscape for ingestible event marker systems is relatively new and evolving. The novelty of this invention lies in its ability to provide real-time monitoring of medication adherence and other ingestible events. Prior art in this field includes various types of ingestible sensors, but none have achieved the same level of real-time monitoring and data transmission as described in this patent[4].
Competitors and Similar Patents
Other companies and researchers are also working on similar technologies. For example, patents related to ingestible sensors and monitoring systems have been granted to companies like Medtronic and Abbott. However, the specific combination of an IEM and a personal signal receiver as described in this patent sets it apart from existing technologies[4].
Economic and Market Impact
Valuation of Patents
The value of patents in the healthcare and medical technology sector can be substantial. For instance, the mean price per patent document in recent deals has been around $208,000, with some patents selling for millions of dollars. The value of this patent could be significant given its potential to revolutionize medication adherence and patient monitoring[5].
Market Potential
The market potential for ingestible event marker systems is vast, particularly in the context of chronic disease management and personalized medicine. With the increasing focus on digital health and telemedicine, this technology could see widespread adoption, leading to significant economic benefits for the patent holders and the healthcare industry as a whole.
Technical and Practical Applications
Clinical Use
The practical application of this patent is primarily in clinical settings where medication adherence is crucial. For example, in the management of chronic diseases such as diabetes, hypertension, or psychiatric disorders, ensuring that patients take their medications as prescribed is vital. This system can provide real-time feedback to healthcare providers, enabling better patient care and outcomes[4].
Research and Development
The technology described in this patent can also be used in research settings to study medication adherence and the effects of different treatments. It provides a precise and reliable method for tracking when medications are taken, which can be invaluable in clinical trials and observational studies.
Regulatory Considerations
FDA Approval
Any medical device, including ingestible event markers, must undergo rigorous testing and obtain FDA approval before it can be marketed and used in clinical settings. The regulatory process involves demonstrating safety, efficacy, and compliance with FDA guidelines, which can be a lengthy and costly process[4].
Intellectual Property Protection
The patent provides intellectual property protection for the inventors and assignees, preventing others from making, using, or selling the invention without permission. This protection is crucial for encouraging innovation and investment in research and development.
Future Directions
Advancements in Technology
Future advancements in this field could include improvements in the design and functionality of the IEM, such as reducing its size or enhancing its signal strength. Integration with other wearable devices or smartphones could also expand its utility and user base.
Broader Applications
Beyond medication adherence, ingestible event markers could have broader applications in fields such as nutrition, fitness, and environmental monitoring. For example, they could be used to track the ingestion of specific nutrients or contaminants, providing valuable data for health and wellness programs.
Key Takeaways
- Innovative Technology: The patent introduces a novel system for real-time monitoring of medication adherence using ingestible event markers.
- Economic Potential: The value of this patent could be significant due to its potential to revolutionize patient monitoring and medication adherence.
- Clinical Applications: The system has practical applications in clinical settings for managing chronic diseases and improving patient outcomes.
- Regulatory Considerations: FDA approval and intellectual property protection are crucial for the commercialization and use of this technology.
- Future Directions: Future advancements could include improvements in design, integration with other devices, and broader applications beyond medication adherence.
FAQs
Q: What is the primary function of the ingestible event marker system described in US Patent 10,441,194?
A: The primary function is to track the ingestion of medications or other events in real-time, providing a signal to a personal signal receiver upon contact with bodily fluids.
Q: Who are the inventors and assignees of this patent?
A: The inventors are a team of researchers and engineers at Proteus Digital Health, Inc., and the patent is assigned to Proteus Digital Health, Inc.
Q: What is the significance of the patent in the healthcare industry?
A: The patent is significant because it provides a novel method for real-time monitoring of medication adherence, which can improve patient outcomes and revolutionize the management of chronic diseases.
Q: What are the potential economic benefits of this patent?
A: The potential economic benefits include significant valuation of the patent, market potential in the digital health sector, and economic benefits from improved patient care and outcomes.
Q: What regulatory approvals are required for the commercialization of this technology?
A: The technology must undergo rigorous testing and obtain FDA approval before it can be marketed and used in clinical settings.
Sources
- USPTO Search for Patents - USPTO
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims Research Dataset - USPTO
- US10441194B2 - Ingestible event marker systems - Google Patents
- The value of a patent - Perpetual Motion Patents
