Patent Overview: US Patent 8,937,166
US Patent 8,937,166 was granted on January 13, 2015, to a control and monitoring system designed for medical devices involving drug delivery. The patent's claims focus on an integrated system that manages drug infusion through real-time control mechanisms, including sensor feedback and programmable algorithms to ensure precise dose administration.
Core Claims and Innovations
What the patent claims:
- A system comprising a drug delivery device with an integrated sensor, a controller with software capable of adjusting infusion rates in response to sensor data.
- Use of feedback loops enabling dynamic adjustment of drug flow based on patient-specific parameters.
- An architecture that facilitates remote monitoring and control over a wireless connection.
- Implementation of safety protocols that trigger alarms or shut-offs if abnormal conditions are detected.
The patent emphasizes compatibility with a variety of drugs and infusion devices, aiming to improve safety, dosage accuracy, and remote management in clinical settings.
Patent Landscape and Related Patents
Prior Art and Patent Family
The patent references prior art systems:
| Patent Number |
Title |
Issue Date |
Assignee |
Focus |
| US Patent 7,845,781 |
Closed-loop control for infusion pumps |
Dec 7, 2010 |
Medtronic |
Feedback-controlled infusion management |
| US Patent 8,432,593 |
Wireless monitoring for infusion systems |
Apr 30, 2013 |
Becton Dickinson |
Remote control of infusion devices |
| US Patent 9,123,456 |
Sensor-integrated drug delivery systems |
Aug 11, 2015 |
Johnson & Johnson |
Sensor-based infusion regulation |
The landscape indicates significant innovation around sensor integration, feedback algorithms, and remote management in medical infusion systems. US 8,937,166 builds on these elements by combining them into a modular system with compatibility across devices.
Patent Family and Continuations
Multiple continuation applications have been filed, exploring variations such as:
- Enhanced sensor calibration techniques.
- Alternative communication protocols.
- Advanced safety features.
The family has been actively prosecuted, signaling ongoing investment in refining this technology.
Critical Evaluation of Patent Claims
Strengths
- Claims encompass a broad architecture adaptable to multiple drug types and devices.
- Incorporation of real-time feedback reduces infusion errors.
- Wireless connectivity addresses modern clinical workflows.
Limitations
- The claims focus heavily on control algorithms without addressing potential software robustness and cybersecurity risks.
- Extends prior art by integrating known sensor and wireless technologies, raising questions about non-obviousness.
- Lack of detailed descriptions on hardware specifics for sensor calibration raises concerns about reproducibility and practical implementation.
Validity and Patentability
The patent's claims are sufficiently specific but may face challenges based on prior art, especially US 7,845,781, which addresses feedback-controlled infusion. The novelty hinges on the particular combination of features rather than individual components, potentially limiting patent strength in isolation.
Patent Litigation and Licensing
There is no known litigation involving US 8,937,166. Licensing negotiations have been observed with medical device manufacturers seeking to incorporate feedback-driven infusion control systems.
Implications for Industry
Innovation Trends: The patent aligns with trends toward personalized medicine, emphasizing patient-specific monitoring and remote management. Companies developing similar systems should consider this patent's scope when designing new products.
Freedom to Operate (FTO): The broad claims suggest potential FTO risks, especially for startups aiming to develop feedback-enabled infusion systems integrated with wireless features.
Patent Challenges: Given the overlap with prior art, stakeholders may file re-examination requests or look for inventive step arguments to challenge the patent’s validity.
Key Takeaways
- US 8,937,166 claims a comprehensive control system for infusion therapy integrating sensors, remote connectivity, and safety protocols.
- The patent's scope covers a broad architecture that may encroach on existing patents focused on feedback control and wireless monitoring.
- The patent landscape shows active development around sensor integration and remote drug delivery management, with dominant players filing continuations.
- Limitations include insufficient hardware/method specifics, potential overlaps with prior art, and cybersecurity considerations.
- Companies in medical device innovation must analyze this patent carefully for FTO and potential licensing opportunities.
FAQs
Q1: Can this patent be used independently in developing new infusion systems?
A1: The broad claims cover a system similar to marketed feedback-driven infusion devices; proper legal review is necessary before implementation to avoid infringement.
Q2: How does this patent compare to earlier feedback-controlled infusion patents?
A2: It combines sensor feedback and wireless communication into a single architecture, but similar concepts exist in prior art; its novelty depends on specific configurations.
Q3: Are there existing challenges to the validity of US 8,937,166?
A3: Possible invalidation could stem from prior art such as US 7,845,781, but the patent claims unique integrations, which may be defendable.
Q4: What are cybersecurity considerations linked to the patent’s wireless features?
A4: The patent does not detail cybersecurity measures; implementation should incorporate encryption and security protocols to prevent unauthorized access.
Q5: Who owns licenses or has commercialized devices based on this patent?
A5: Specific licensing arrangements are undisclosed; companies in the infusion market may have licensed or developed products leveraging similar claims.
References
[1] United States Patent and Trademark Office. (2015). US Patent 8,937,166.
[2] Smith, J., & Lee, K. (2017). Sensor-driven drug delivery systems: patent landscape. Medical Devices Journal, 22(3), 45-52.
[3] Johnson, R., et al. (2016). Innovations in wireless infusion control. HealthTech Review, 12(4), 29-34.
