Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the application filed on May 30, 2025.
2. Claim(s) 1-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Independent Claim(s) 1 and 11 are directed to an abstract idea consisting of a service platform configured to receive usage data relating to at least one parameter of the medical device and determine a diagnostic status of the medical device based on the received usage data, triggering a notification indicating whether the medical device should be reallocated to a different location in the healthcare facility based on the diagnostic status, and displaying the notification that the medical device should be reallocated to the different location in the healthcare facility.
Independent Claim 1 recites “receive usage data relating to at least one parameter of the medical device and determine a diagnostic status of the medical device based on the received usage data, wherein the service platform triggers a notification indicating whether the medical device should be reallocated to a different location in the healthcare facility based on the diagnostic status, and displaying the notification that the medical device should be reallocated to the different location in the healthcare facility.”
Independent Claim 11 recites “generating usage data relating to at least one parameter of the medical device, transmitting the usage data to determine a diagnostic status of the medical device based on the usage data, triggering a notification indicating whether the medical device should be reallocated to a different location in the healthcare facility based on the diagnostic status, and displaying the notification that the medical device should be reallocated to the different location in the healthcare facility.”
The limitations of Claims 1 and 11, as drafted, under its broadest reasonable interpretation, covers the performance of a Mental Process which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion) wherein the claims recite “determine a diagnostic status of the medical device based on the received usage data,” “determine a diagnostic status of the medical device based on the usage data,” “determine an average usage of the plurality of medical devices,” “compares the medical device usage data for each medical device to the average,” “determines whether the usage … has reached or exceeded a predetermined limit,” “determines whether the medical devices usage exceeds a threshold for service or replacement,” “determines if the usage … has exceed a factor of the average usage,” and “indicating” various statuses and reallocations, all of which are evaluations and judgments that can, at a high level of generality, be performed in the human mind or with pencil and paper. Additionally, Claims 1 and 11, as drafted, under its broadest reasonable interpretation, covers the performance of Certain Methods Of Organizing Human Activity which are concepts performed by managing personal behavior, relationships or interactions between people (including fundamental economic principles, commercial or legal interactions, social activities, teaching, and following rules or instructions) wherein the claims recite “reallocating a medical device in a healthcare facility,” “reallocated to a different location in the healthcare facility,” “reallocated to an area of the healthcare facility where the medical devices will experience lower usage,” “swapped with the first medical device,” and “indicating a location of the second medical device,” which describe organizing resources and workflows (where devices should be located and when they should be swapped, repaired, or replaced) within a healthcare facility, but for the recitation of generic computer components. That is, other than reciting, “service platform and display” nothing in the claim element precludes the step from practically being performed in the mind or following rules or instructions. For example, but for the “service platform” language, “receiving” in the context of this claim encompasses the user manually retrieving usage data relating to at least one parameter of the medical device and determine a diagnostic status. Similarly, the displaying the notification that the medical device should be reallocated to the different location in the healthcare facility, covers performance of the limitation in the mind or following rules or instructions, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes and Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “service platform and display” to perform all of the “obtaining, transforming, parsing, determining, transforming, selecting and storing” steps. The “service platform and display” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1 and 11 have the following additional elements (i.e., service platform and display). Looking to the specification, these components are described at a high level of generality. The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 2-10 and 12-20). Particularly, each of the dependent claims also fails to amount to “significantly more’ than the abstract idea since each dependent claim is directed to a further abstract idea, and/or a further conventional computer element/function utilized to facilitate the abstract idea. Accordingly, none of the current claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology). These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Processes and Certain Methods of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claims 1-20 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1–20 are rejected under 35 U.S.C. §103 as unpatentable over Pub. No.: US 2014/0018637 A1 to Bennett et al. in view of Pub. No.: US 2013/0160082 A1 to Miller.
Claim 1:
“A diagnostic monitoring system for a medical device in a healthcare facility, the diagnostic monitoring system comprising: a service platform configured to receive usage data relating to at least one parameter of the medical device and determine a diagnostic status of the medical device based on the received usage data, wherein the service platform triggers a notification indicating whether the medical device should be reallocated to a different location in the healthcare facility based on the diagnostic status, and a display for displaying the notification that the medical device should be reallocated to the different location in the healthcare facility.”
Bennett et al. teaches a system in which a communications device is integrated into a remotely deployed medical device to monitor the operative status and use of the device, and in which the medical device communicates informational data to a Cloud server or professional caregiver without requiring patient input. Bennett further teaches that a remotely deployed medical device such as a defibrillator provides periodic reports regarding operational status, including remaining battery life, and that the communications device can be accessed remotely and directly queried to provide requested informational data, thus providing real-time access to the status and utilization of the medical device. See paragraph 41-42 and claims 9–11, 17–24.
Bennett et al. also teaches that the service platform triggers notifications and provides displays for those notifications. Bennett states that the Cloud computing and storage site can provide an alert to the pertinent medical professional if transmitted data is not within predetermined limits, and that the professional caregiver may be passively notified by text message, phone call, pager message, push mail on a smart phone, or a pop-up notification on a computer screen or smart phone screen. Bennett further teaches that caregivers can access the data cloud through multiple modalities, including a smart phone application, a computer program, a website, or an online portal of a hospital intranet. See paragraphs 19, 26, 37 and claims 9–10, 23–24.
Bennett et al. fails to explicitly teach that the notification indicates whether the medical device should be reallocated to a different location in the healthcare facility based on the diagnostic status, or that the displayed notification specifically instructs reallocation between locations within the healthcare facility.
Miller teaches a system for connecting a plurality of medical devices in a health care facility to a hospital information system through a device server, identifying and authenticating medical devices, and providing an administrator or privileged user access to information received from the medical device at a remote location. Miller also teaches a terminal and display architecture and systems that remotely connect, monitor, and diagnose medical devices once the medical device has been located and analyzed by the hospital information systems. See paragraphs 7-8, 16, 65, 75 and claims 1–2, 8, 15–17.
Miller further teaches centralized administrator visibility over many devices in a facility. Miller states that the system may provide access to any number of medical devices in a health care facility, and that the DSM and DSCs enable the VDN administrator to discover medical devices located within the facility and to set up and manage individual Virtual IP addresses and routes to allow access to each of the individual medical devices located within a desired facility. Miller also teaches that error messages, device data, and other information may be sent remotely to the administrator for analysis and review. See paragraphs 34-35, 50, 59 and claim 15.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Bennett’s remote/cloud monitoring system to generate a notification indicating whether a medical device should be reallocated to a different location in the healthcare facility based on diagnostic status and usage information, in view of Miller’s teachings of centralized facility-wide device connectivity, device discovery within the facility, administrator review of device data and error messages, and remote management of multiple medical devices. Such a modification would have predictably improved utilization balancing, maintenance planning, and administrative management of medical devices across a healthcare facility.
Claim 2:
“Bennett et al. and Miller teach the system of claim 1, wherein the usage data includes a cycle count of the medical device.”
Bennett et al. teaches usage data corresponding to a cycle count. Bennett states that the informational data received from a medical device can include ON/OFF flags, the duration where the therapy was on, intentional interruption of therapy, erratic therapy behavior, and prolonged irregular inactivity. Bennett also teaches that the doctor can determine utilization rate with regard to the length of therapy and the frequency of therapy. These disclosures teach counting repeated uses or operating cycles of the device. See paragraphs 39, 64 claims 13–15, 17–24.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 3:
“Bennett et al. and Miller teach the system of claim 1, wherein the usage data includes a total run time of the medical device.”
Bennett et al. teaches total run time as usage data. Bennett discloses monitoring the length of time the device is operated and states that the doctor can determine utilization rate with regard to the length of therapy. Bennett also teaches reporting when and for how long the medical device was operated. See paragraph 52 and claims 13–15.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 4:
“Bennett et al. and Miller teach the system of claim 1, wherein the diagnostic status indicates that the medical device has reached half of an expected life based on at least one of a cycle count and a total run time of the medical device.”
Bennett et al. teaches determining operational status and remaining battery life, periodic reporting of such status, and making service decisions when maintenance is needed. Bennett also teaches storing operational and informational data on a Cloud server, applying predictive modeling software to analyze the data, and generating alerts when data is outside a predetermined range of values. See paragraphs 41-42, 57 and claims 3–6, 18–20.
Bennett et al. does not expressly teach the specific threshold of “half of an expected life.”
However, in view of Bennett’s explicit teachings of usage-based and status-based monitoring, remaining life reporting, predictive modeling, and threshold-based alerts, selecting an intermediate life threshold such as half of an expected life based on cycle count and/or total run time would have been an obvious matter of routine design choice for predictive maintenance and service scheduling. See paragraphs 39-42 and 57.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 5:
“Bennett et al. and Miller teach the system of claim 1, wherein the diagnostic status indicates that the device is approaching an end of an expected life based on at least one of a cycle count and a total run time of the medical device.”
Bennett et al. teaches diagnostic status indicating approach to end of expected life. Bennett discloses reporting operational status and remaining battery life of a defibrillator, and allowing responsible personnel to determine whether the defibrillator should be serviced to maintain it in operative condition for a predetermined period of time. Bennett also teaches alerts when parameters are outside acceptable or predetermined ranges. See paragraphs 40-42, 62 and claims 3–6, 18, 20.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 6:
“Bennett et al. and Miller teach the system of claim 1, wherein the diagnostic status indicates that the device is being used at a higher rate than an average rate of usage based on at least one of a cycle count and a total run time of the medical device.”
Bennett et al. teaches monitoring device usage, including length of use and frequency of therapy, and storing that information on a server for review by caregivers. See paragraphs 39, 64 and claims 14–15, 17–24.
Bennett et al. does not expressly teach comparing one device’s usage to an average usage rate.
Miller teaches centralized connectivity and administrator analysis across a plurality of medical devices in a healthcare facility. Miller teaches that the system connects multiple devices, provides administrator access to information received from devices at a remote location, allows remote monitoring and diagnostics, and sends error messages, device data, and other information to an administrator for analysis and review. Miller also teaches a facility-wide DSM/DSC architecture that discovers medical devices located within the facility and manages access to them. See paragraphs 34-35, 65-66 and claims 8, 15–17.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 7:
“Bennett et al. and Miller teach the system of claim 1, wherein the notification indicates that the medical device should be reallocated to a location in the healthcare facility where the medical device will experience a lower rate of usage based on at least one of a cycle count and a total run time of the medical device.”
Miller teaches facility-wide access to many devices, discovery of devices located within the facility, and administrator management of access routes to individual devices in desired facility locations. Miller also teaches remote monitoring, diagnostics, and administrator analysis of device data and malfunction information. See paragraphs 35, 53, 77 and claims 8, 14–17.
Accordingly, it would have been obvious to use Bennett’s usage and run-time data together with Miller’s facility-wide device visibility and administrator analysis to generate a notification recommending reallocation of an overused device to a lower-usage location in the facility, thereby balancing wear, improving availability, and extending useful life.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 8:
“The system of claim 1, wherein: the medical device is a first medical device, and the notification indicates a second medical device to swap with the first medical device.”
Neither Bennett et al. nor Miller expressly teaches a notification identifying a specific second medical device to swap with a first device.
However, given Miller’s as previously cited teaching of facility-wide discovery and administrator management of multiple medical devices located within the facility, and Bennett’s teaching of usage-based monitoring for individual devices, it would have been obvious to specify in a reallocation notice a second device as a swap partner selected from another location based on relative usage, so as to maintain service availability while balancing utilization. See Miller paragraphs 35, 53, 77 and claims 8, 14–17. See Bennett et al. paragraphs 39-42 and 57.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 9:
“Bennett et al. and Miller teach the system of claim 8, wherein the notification indicates a location of the second medical device.”
Miller teaches that the system enables an administrator to discover medical devices located within the facility and to manage routes allowing access to individual medical devices located within a desired facility. See Miller paragraphs 35, 53, 77 and claims 8, 14–17.
Given Miller’s explicit teaching of discovering devices located within the facility, it would have been obvious to include the location of the second medical device in the notification so staff can locate the swap device efficiently.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
Claim 10:
“Bennett et al. and Miller teach the system of claim 1, wherein the service platform is located remotely from the medical device.”
Bennett et al. expressly teaches a remote Cloud server and remote central station. Bennett states that the medical device communicates directly with a remote Cloud server, that data is stored on an off-site server, and that the principles are also effective in a hospital environment where communications devices on medical devices send collected data to a central station and stored server or Cloud server. See paragraphs 29-30, 61, 71 and claims 9–11, 16–24.
The obviousness of combining the teachings of Bennett et al. and Miller are discussed in the rejection of claim 1, and incorporated herein.
As per Claims 11-20, Claims 11-20 are directed to a method for reallocating a medical device in a healthcare facility. Claims 11-20 recite the same or substantially similar limitations as those addressed above for Claims 1-10 as taught by Bennett et al. and Miller. Claims 11-20 are therefore rejected for the same reasons as set forth above for Claims 1-10 respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pub. No.: US 20130132109 A1: A system for remote management of patients and medical devices is provided. The system comprises one or more medical devices configured to measure one or more patient's health parameters. Further, the system comprises a personal health gateway configured to receive the one or more measured patient's health parameters. The personal health gateway further comprises a management module. Furthermore, the system comprises a public network configured to connect the one or more personal health gateways to a managed patient services platform. The managed patient services platform is configured to facilitate remote management of the one or more medical devices and patients. The managed patient services platform further comprises a management module. The system comprises a hospital system configured to facilitate one or more functionality of a healthcare facility. The management module facilitates medical device management and remote health management by embedding a healthcare protocol with a device management protocol.
Pub. No.: US 20220415493 A1: The system has a service platform (18) communicated with a medical device (12). A manufacturer database (20) is communicated with the service platform, where the manufacturer database includes data related to the medical device. A remote service system (28) is communicated with the service platform. The medical device sends registration request to the manufacturer database by the service platform, where the registration request includes serial number of the medical device. The manufacturer database returns unique device credentials to the medical device based on recognizing the serial number of the medical device. The remote service system identifies the medical device based on the unique device credentials.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683
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