Obviousness

Obviousness Analysis under 35 U.S.C. § 103 for US Patent 8630699

This analysis identifies combinations of prior art references, as described within US Patent 8630699 itself, that would render its claims obvious to a person having ordinary skill in the art (PHOSITA).

General Motivation for Combining Prior Art

A PHOSITA is generally motivated to improve existing devices, address known problems or shortcomings, miniaturize components, reduce manufacturing costs, enhance user convenience, and improve device efficiency, particularly for battery-operated portable devices. The background section of US8630699 explicitly details several problems with existing physiological monitors, which would provide strong motivation for a PHOSITA to combine and modify known technologies in the ways described in the claims. These problems include:

• The need for wires from sensors to portable units, leading to tangling, discomfort, accidental unplugging, and increased ECG noise (triboelectric effect).
• The bulky physical volume of conventional power resistors used for defibrillation protection, which are unsuitable for compact monitors.
• The lack of intelligence in small sensor devices to vary transmitted data, and the inability of existing small portable monitors to perform computationally intensive arrhythmia analysis.
• The time-consuming and costly nature of portable monitor battery maintenance.

Obviousness of Independent Claim 1

Claim 1: A body worn patient monitoring device comprising at least one disposable module including a plurality of electrical connections to the body... a disposable module connector... at least one internal or external power source... at least one communication-computation module, having a communication-computation module connector to receive physiological signals... at least one microprocessor to actively monitor the patient and to perform a real-time physiological analysis... and a radio circuit to communicate a raw physiological signal or a result of the physiological analysis at a predetermined time or on the occurrence of a predetermined event, via a radio transmission to a remote radio receiver, wherein the at least one disposable module is mechanically and electrically coupled directly to the at least one communication-computation module, and wherein the body worn patient monitoring device... is directly non-permanently affixed to the skin surface of the patient.

Prior Art Combination:

1. "Micropaq wireless patient monitor" (Welch Allyn, Inc.): This device is described as a "small, rugged, lightweight, patient-wearable device" that "permits multi-parameter monitoring and patient alarm capabilities" and "transmits the sensed heart beat... by wireless techniques, the sensor transmits the sensed heart beat to a nearby microcomputer based monitor and display." This reference teaches a body-wearable device with wireless communication and a microcomputer.
2. General "Portable patient monitors" and "Heart rate monitor typically used by individuals engaged in an athletic activity": These references teach that "sensors, such as ECG electrodes, are affixed to the patient's body, such as with tape, and connected to the battery operated monitor by wires." They also confirm the use of battery power for portability.
3. Explicit Problem Statement in US8630699 Background: The patent highlights the "recurrent problem with the portable monitors typically used in healthcare applications is the need for wires from sensors situated on the patient's body to the portable unit."
4. Common medical practice: The use of disposable electrodes is well-established in the medical field for hygiene and convenience.
5. U.S. patent application Ser. No. 11/031,736: This is incorporated by reference for "details of such monitoring networks" and describes an "integrated wireless monitoring network."

Motivation for Combination:
A PHOSITA would be strongly motivated to eliminate the "recurrent problem" of wires in portable patient monitors, as articulated in the patent's background. Given that the "Micropaq wireless patient monitor" already demonstrated a "patient-wearable" device with "wireless techniques" and a "microcomputer", the next logical step to eliminate wires would be to integrate the sensors directly into the device rather than connecting them via external leads. The common practice of disposable electrodes would motivate placing them in a disposable module. Attaching this disposable module directly to the computation/communication module, and then affixing the entire integrated unit directly to the patient's skin, directly addresses the wire problem, improves patient comfort, and reduces noise. The motivation to incorporate "real-time physiological analysis" and intelligent wireless communication "at a predetermined time or on the occurrence of a predetermined event" is clearly stated in the patent as a solution to the shortcomings of existing small devices that "lack the intelligence to vary the amount and type of data transmitted" or cannot perform "arrhythmia analysis." The "U.S. patent application Ser. No. 11/031,736" further reinforces the motivation for integrated wireless monitoring networks.

Obviousness of Independent Claim 12

Claim 12: A method of providing high voltage circuit protection for a body worn monitor comprising the steps of: providing a substrate that supports one or more electrical connections to a patient's body; determining a print pattern and thickness of a first material having a first resistivity to be printed on the substrate; determining a print pattern and thickness of a second material having a second resistivity to be printed on the substrate; printing the first material onto the substrate; and printing the second material onto the substrate wherein at least part of the second material overlays the first material.

Prior Art Combination:

1. Conventional defibrillation protection: The patent states that the requirement for medical-grade monitors to "survive multiple defibrillation cycles of at least 360 joules" has "Conventionally... been met by one or more power resistors situated in series with the wire leads of a fixed or portable physiological monitor."
2. Problem statement in US8630699 Background: "The problem is that the physical volume of conventional power resistors is too large for use in a compact monitor application."
3. Known manufacturing techniques: Screen printing, the use of various inks (e.g., carbon, silver) with different resistivities, and the concept of layering materials on a substrate were well-known in the art of printed electronics and circuit board manufacturing. The patent itself describes using "silk screen printing method" to deposit "carbon paste conductor" and "silver ink" on a "Mylar substrate." The patent also discusses overlaying materials (e.g., "a carbon annulus pattern can be deposited before the conductive surface 404 is deposited. Conductive surface 404 can then be deposited as an overlay over the earlier formed carbon annulus shape").

Motivation for Combination:
A PHOSITA, faced with the explicit problem of the "physical volume of conventional power resistors" being "too large for use in a compact monitor application", would be motivated to find a miniaturized solution for defibrillation protection. Given the widespread knowledge of printing techniques for creating conductive and resistive traces on flexible substrates, it would be obvious to replace bulky discrete resistors with printed resistive elements directly on the electrode substrate. The use of different materials with varying resistivities (e.g., carbon for high resistance, silver for conductivity) and the technique of overlaying these materials to form integrated traces are standard practices in printed circuit design to achieve specific electrical properties and robust connections. The patent's own detailed description of solving "arcing at the interface between the carbon and conductive traces" by overlaying or using fillet shapes suggests that a PHOSITA would be aware of these challenges and corresponding solutions in combining such materials. Thus, applying these known printing and layering methods to create compact, defibrillation-resistant traces for a body-worn monitor would be an obvious design choice to solve the stated problem of size.

Obviousness of Independent Claim 17

Claim 17: A body worn patient monitoring device comprising: means for performing real-time physiological analysis of signals from a patient; a radio for communicating results of the real-time physiological analysis at a predetermined time or on the occurrence of a predetermined event; and a power management circuit configured to reduce power consumption by causing the device to enter a sleep mode during periods when useful physiological data is not being acquired and to exit the sleep mode to actively monitor the patient and perform the real-time physiological analysis.

Prior Art Combination:

1. "Micropaq wireless patient monitor": This device is a "patient-wearable device" with "multi-parameter monitoring and patient alarm capabilities" and a "microcomputer" that transmits sensed heartbeats wirelessly. This provides the body-worn aspect, a processing unit, and wireless communication.
2. Problem statements in US8630699 Background: The patent identifies that "portable monitor battery maintenance (e.g. battery recharging or replacement) can be time consuming and costly" and that existing small devices "lack the intelligence to vary the amount and type of data transmitted."
3. General knowledge of power management in battery-operated electronics: It was well-known in the art of portable, battery-powered electronic devices (e.g., cell phones, athletic monitors, other medical devices) to implement power-saving features such as "sleep modes" or "power-down modes" for microprocessors and circuits during periods of inactivity to extend battery life.
4. Patent's own description of power saving: "When viewed over time, most of the ECG waveform does not contain useful information since there is significant 'dead time' between heart beats. For this reason, circuits can be powered down (in a device 'sleep mode') to save on the order of 60% of the energy stored in the power source that would have otherwise been used during this dead time." The patent also describes putting the "microcontroller and/or other circuits...into a sleep mode during an ADC conversion cycle" and "buffering" data to batch-process it.

Motivation for Combination:
A PHOSITA concerned with the "time consuming and costly" battery maintenance for portable patient monitors would be highly motivated to implement power-saving strategies. Given that the "Micropaq wireless patient monitor" already included a "microcomputer" and wireless communication in a "patient-wearable device", integrating "real-time physiological analysis" into such a device would address the identified "shortcoming" of small devices lacking intelligence. It would be an obvious step for a PHOSITA to apply known power management techniques, such as sleep modes, to these computationally capable, battery-powered, body-worn devices. The patent explicitly states that "most of the ECG waveform does not contain useful information since there is significant 'dead time' between heart beats," thereby providing a clear justification for entering a sleep mode during such periods. The intelligent communication of results "at a predetermined time or on the occurrence of a predetermined event" further supports the efficiency of the power management, as the radio would not need to be constantly active.

Obviousness of Independent Claim 18

Claim 18: A body worn patient monitoring device comprising: a first portion being disposable, the first portion including at least one electrode for attachment to a patient's body and a power source; a second portion being reusable and detachably coupled to the first portion, the second portion including a microprocessor for actively monitoring the patient and a radio circuit for wireless communication of physiological signals or results of physiological analysis; and wherein the body worn patient monitoring device is configured to be directly, non-permanently affixed to the patient's body.

Prior Art Combination:

1. General "Portable patient monitors": These monitors use "sensors, such as ECG electrodes, are affixed to the patient's body, such as with tape" and are "battery operated."
2. "Micropaq wireless patient monitor": A "patient-wearable device" with "multi-parameter monitoring and patient alarm capabilities" and a "microcomputer" that transmits heartbeats "by wireless techniques."
3. Problem statement in US8630699 Background: The patent identifies a need for "a body worn combined physiological sensor and monitor having a disposable sensor, but used and worn by a patient as a single unit directly and non-permanently affixed to a patient's body."
4. Common medical device design principles: It is well-known to separate medical devices into disposable (consumable, single-use, or short-term use) and reusable (expensive electronics, long-term use) components for hygiene, cost-effectiveness, and ease of replacement.
5. Patent's own disclosure of components: The patent clearly describes "a removable and reusable communications and computation module 102 and a disposable electrode module 110," where the disposable module includes "electrode gels 103... and batteries 204 to power communications and computation module 102." It also details a "retention clip 104, to mechanically attach communications and computation module 102 to the top surface of the disposable electrode module 110."

Motivation for Combination:
A PHOSITA, seeking to fulfill the stated need for a "body worn combined physiological sensor and monitor having a disposable sensor" and addressing the high cost and maintenance of traditional medical monitors, would be motivated to design a modular system. The widely adopted practice of using disposable electrodes for medical monitoring, combined with the desirability of a reusable electronics core (like the "microcomputer" and wireless capabilities of the Micropaq), would naturally lead to a two-part design. Placing the power source (batteries) in the disposable portion alongside the electrodes is an obvious design choice to simplify maintenance for the user – replacing the entire disposable module, which includes components that degrade with use (electrodes) and components that deplete (batteries), in one step. The mechanical and electrical "detachable coupling" would be implemented using standard connectors and clips, as taught by the patent's own figures and description (e.g., retention clip 104). The configuration of the entire device to be "directly, non-permanently affixed to the patient's body" is driven by the patent's explicit goal of eliminating external wires and their associated problems.