DETAILED ACTION
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 .
Notice to Applicant
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/31/2025; 7/25/2025; and 9/11/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
3. 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.
Claims 1-20 are directed to improving medical device performance based on data of a patient environment, which is considered managing personal behavior. Managing personal behavior fall within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea).
Under step 1 of the Alice/Mayo framework, it must be considered whether the claims are directed to one of the four statutory classes of invention. In the instant case, claims 1-10 and 20 recite a system comprising at least one processing device and at least one computer readable data storage device. Claims 11-19 recite a method and at least one step. Therefore, the claims are each directed to one of the four statutory categories of invention (manufacture and process).
Under step 2A of the Alice/Mayo framework, it must be considered whether the claims are “directed to” an abstract idea. That is, whether the claims recite an abstract idea and fail to integrate the abstract idea into a practical application.
Regarding independent claim 1, the claim sets forth a process in which product or service recommendations are determined for a consumer, including through the facilitation of consumer-to-business interaction, in the following limitations:
receive video data of a patient environment where positioned;
analyze the video data to determine a status; and
adjust an operation based on the status.
The above-recited limitations manage personal behaviors, improving medical device performance of a patient environment. This arrangement amounts to both managing personal behavior and interactions between people. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)).
Claim 1 does recite additional elements:
at least one medical device.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“at least one medical device”) and insignificant pre-and-post solution activity (receiving, analyzing, and adjusting). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 0039, 0070, 0085, 0086, and 0092 indicate that while exemplary general purpose systems may be specific for descriptive purposes, any elements or combinations of elements capable of implementing the claimed invention are acceptable. That is, the technology used to implement the invention is not specific or integral to the claim.
Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea.
Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea
Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Communicating information (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent.
Independent Claims 11 and 20 are parallel in scope to claim 1 and ineligible for similar reasons.
Dependent claims
Each of these steps of the dependent claims 2-10 and 12-19 only serve to further limit or specify the features of independent claims 1 and 11 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements already analyzed in the expected manner
For example, regarding Claims 3 and 13
Claims 3 and 13 set forth:
generate a recommendation to reallocate among the plurality of patient environments within the healthcare facility based on the statuses.
Such a recitation merely embellishes the abstract idea of managing personal behaviors, improving medical device performance of a patient environment. While the claim does set forth the additional limitation of “the plurality of medical devices”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment.
Additionally, dependent claims 2, 4, 12, and 14 recite a plurality of medical devices, claims 5 and 15 recite at least one medical device, a graphical user interface, and a display, claims 6-8 and 16-18 recite at least one medical device.
These recitations are similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment.
As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication Number 2015/0109442, Derenne, et al., hereinafter Derenne.
Regarding claim 1, Derenne discloses a system for improving medical device performance, the system comprising:
at least one processing device, (Fig. 2); and
at least one computer readable data storage device storing software instructions that, when executed by the at least one processing device, (Figures 2-4) cause the at least one processing device to:
receive video data of a patient environment where at least one medical device is positioned, (para. 64, A video monitoring system 20 according to a first embodiment is shown in FIG. 1. Monitoring system 20 includes one or more conventional video cameras 22 and/or other types of vision sensing or motion sensing equipment. Video monitoring system 20 is adapted to sense one or more conditions in a room or other environment, and/or to sense one or more actions undertaken by one or more persons in the room or other environment);
analyze the video data to determine a status of the at least one medical device, (para. 217, computer device 24 is configured to determine any one or more of the following conditions based upon information received from patient support apparatus computer device 70: whether the bed is at its lowest height; whether the bed's brakes are on or not; whether and which ones of the bed's siderails are up; and/or whether the bed's exit detection system is armed or not and paragraphs 294-295, Equipment Monitoring [0295] In at least one embodiment of system 20, computer device 24 executes a patient support apparatus software module 34 that effectively converts "dumb" patient support apparatuses into "smart" patient support apparatuses. More specifically, such a patient support apparatus software module 34 detects a number of parameters regarding one or more patient support apparatuses 36 that could otherwise be detected by sensors on-board the patient support apparatus); and
adjust an operation of the at least one medical device based on the status, (para. 217, as least one software module 34 is also adapted to automatically activate the brake of the patient support apparatus 36 if the caregiver exits the room of a patient without activating the brake).
Regarding claim 2, Derenne discloses the system of claim 1 as described above. Derenne further discloses wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to:
receive video data of a plurality of patient environments within a healthcare facility, (Fig. 3, para. 81, a computer device 24 positioned in each room that is dedicated to processing the images and/or depth sensor readings generated by the cameras);
analyze the video data of the plurality of patient environments to determine statuses of a plurality of medical devices in the healthcare facility, (para. 82, After processing all or a portion of the data received from the cameras 22, the in-room computer devices 24 of FIG. 3 transmit messages regarding such processing onto the hospital network); and
adjust the operations of the plurality of medical devices based on the statuses of the plurality of medical devices, (para. 82, Video monitoring system 20 is configured to interact and communicate with all of these types of existing equipment, and/or any subsets of them. Indeed, in some embodiments, video monitoring system 20 operates without needing to interact with any of the existing IT equipment discussed below in subsection and para. 217, as least one software module 34 is also adapted to automatically activate the brake of the patient support apparatus 36 if the caregiver exits the room of a patient without activating the brake).
Regarding claim 3, Derenne discloses the system of claims 1 and 2 as described above. Derenne further discloses wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to:
generate a recommendation to reallocate the plurality of medical devices among the plurality of patient environments within the healthcare facility based on the statuses of the plurality of medical devices, (para. 159, Work flow computer device 62 is a conventional computer device or software application adapted to manage the assignment of caregivers to particular patients, to oversee the performance of specific caregiver functions, and to manage resources within the hospital environment, para. 294, Equipment Monitoring, para. 298, asset tracking, para. 318, a quality auditing software module 34 that analyzes the quality of care provided to a patient according to a number of different metrics. In some embodiments, authorized personnel at the healthcare institution can custom tailor these metrics to the particular needs of that healthcare institution).
Regarding claim 4, Derenne discloses the system of claims 1 and 2 as described above. Derenne further discloses wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to:
generate benchmark metrics for comparing the healthcare facility to other healthcare facilities based on the statuses of the plurality of medical devices, (para. 100, system 20 can be modified such that a first set of software modules 34 are executed by computer device 24 (or a first one of computer devices 24) for a first set of rooms 28, and a second and different set of software modules 34 are executed by computer device 24 (or a second one of computer devices 24) for a second and different set of rooms. Thus, as but one illustrative example, system 20 may be configured to control one or more devices based upon its recognition of specific gestures of authorized individuals in a specific set of rooms. In rooms outside of that specific set, system 20 may be configured such that, if one or more of the authorized individuals makes a similar gesture in any of the rooms outside of that specific set, system 20 does not control any of those devices, and para. 289, computer device 24 repetitively compares real time images of the patient with a baseline image may over defined time intervals).
Regarding claim 5, Derenne discloses the system of claim 1 as described above. Derenne further discloses wherein when analysis of the video data determines an error status of the at least one medical device, adjust the operation of the at least one medical device includes altering a graphical user interface on a display of the at least one medical device, (Fig. 4, para. 244, This recognition is done by any of the means previously described, including but not limited to, facial recognition, badge recognition, uniform recognition, combinations of these, or by other methods. Once a cleaning person is identified, system 20 determines the location of a mop 108 (FIG. 10) or other utensil (e.g. sponge 106) held by the cleaning person. The end of the mop, or other cleaning utensil, that is used for cleaning is recognized by comparing the detected data from cameras 22 with stored attribute data 44 corresponding to the cleaning instrument. As the individual performs his or her cleaning, those areas of the floor, or other surface being cleaning, are recorded by cameras 22. If the complete surface area of the floor, or other object, are not cleaned prior to the individual leaving the room, an alert is issued).
Regarding claim 6, Derenne discloses the system of claim 1 as described above. Derenne further discloses wherein when analysis of the video data determines an idle status of the at least one medical device, adjust the operation of the at least one medical device includes turning off the at least one medical device, (para 28, The database contains an exit detection algorithm for detecting, based on the image data, when an occupant of the person support apparatus may be about to exit the person support apparatus. The algorithm includes at least one occupant movement threshold used in determining whether to issue an exit detection alert. The computer device communicates with the camera and the database, and the computer device is adapted to analyze the image data to determine if the occupant is engaged in an activity. The computer device adjusts the threshold if the computer device determines that the occupant is engaged in the activity, para. 29, The activity includes eating and/or sleeping in some embodiments. When the activity is sleeping, the computer device analyzes the image data, in at least one embodiment, to determine if the occupant's eyes are open when determining if the occupant is sleeping. When the activity is eating, the computer device analyzes the image data, in at least one embodiment, to determine if one or both of the occupant's hands are repetitively moving toward the occupant's mouth when determining if the occupant is eating and para. 30 The computer device increases the threshold when the occupant is engaged in the activity, thereby requiring greater movement before the exit detection alert is issued).
Regarding claim 7, Derenne discloses the system of claim 1 as described above. Derenne further discloses wherein when analysis of the video data determines a shortage status of the at least one medical device, adjust the operation of the at least one medical device includes adjusting the operation of the at least one medical device to consume less consumables, (para 28, The database contains an exit detection algorithm for detecting, based on the image data, when an occupant of the person support apparatus may be about to exit the person support apparatus. The algorithm includes at least one occupant movement threshold used in determining whether to issue an exit detection alert. The computer device communicates with the camera and the database, and the computer device is adapted to analyze the image data to determine if the occupant is engaged in an activity. The computer device adjusts the threshold if the computer device determines that the occupant is engaged in the activity, para. 29, The activity includes eating and/or sleeping in some embodiments. When the activity is sleeping, the computer device analyzes the image data, in at least one embodiment, to determine if the occupant's eyes are open when determining if the occupant is sleeping. When the activity is eating, the computer device analyzes the image data, in at least one embodiment, to determine if one or both of the occupant's hands are repetitively moving toward the occupant's mouth when determining if the occupant is eating and para. 30 The computer device increases the threshold when the occupant is engaged in the activity, thereby requiring greater movement before the exit detection alert is issued).
Regarding claim 8, Derenne discloses the system of claim 1 as described above. Derenne further discloses wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to:
analyze the video data to determine a classification of a caregiver inside the patient environment, (para. 320, System 20 is also configurable in some embodiments to execute a caregiver presence software module 34 that monitors the presence of a healthcare worker within the patient's room and changes one or more conditions automatically based upon the worker's presence); and
adjust the operation of the at least one medical device based on the classification of the caregiver inside the patient environment, (para. 320, the software module 34 automatically changes what information is displayed on the patient support apparatus 36, or another display in the room, based upon the type of worker enters the room (e.g. technician, cleaning personnel, caregiver, administrator, volunteer, etc.)).
Regarding claim 9, Derenne discloses the system of claim 1 as described above. Derenne further discloses wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to:
monitor the video data over a period of time to determine classifications of a plurality of caregivers who enter and exit the patient environment over the period of time, (para. 173, system 20 is configurable to identify this specific caregiver by means of facial recognition software, a badge identification process based upon a specific badge that caregiver 82 is wearing, an RF ID tag that is worn by caregiver 82, the attire of caregiver 82, and/or a combination of one or more of these means and para. 318, a quality auditing software module 34 that analyzes the quality of care provided to a patient according to a number of different metrics. In some embodiments, authorized personnel at the healthcare institution can custom tailor these metrics to the particular needs of that healthcare institution. In general, such metrics include how well any or all of the healthcare protocols were followed (as detected by system 20), how fast caregivers responded to inquiries or requests, how much time caregivers spent at the patient's bedside, and how many staff were utilized in the care of the patient (including the amount of time for each); and
generate metrics based on the classifications of the plurality of caregivers, (para. 318, a quality auditing software module 34 that analyzes the quality of care provided to a patient according to a number of different metrics. In some embodiments, authorized personnel at the healthcare institution can custom tailor these metrics to the particular needs of that healthcare institution. In general, such metrics include how well any or all of the healthcare protocols were followed (as detected by system 20), how fast caregivers responded to inquiries or requests, how much time caregivers spent at the patient's bedside, and how many staff were utilized in the care of the patient (including the amount of time for each).
Regarding claim 10, Derenne discloses the system of claim 1 as described above. Derenne further discloses wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to:
generate a recommendation to adjust an allocation of caregivers assigned to the patient environment based on at least one of a visit frequency and a time spent by the caregivers in the patient environment determined from the video data of the patient environment, (para. 159, Work flow computer device 62 is a conventional computer device or software application adapted to manage the assignment of caregivers to particular patients, to oversee the performance of specific caregiver functions, and to manage resources within the hospital environment, para. 294, Equipment Monitoring, para. 298, asset tracking, para. 318, a quality auditing software module 34 that analyzes the quality of care provided to a patient according to a number of different metrics. In some embodiments, authorized personnel at the healthcare institution can custom tailor these metrics to the particular needs of that healthcare institution…such metrics include how well any or all of the healthcare protocols were followed (as detected by system 20), how fast caregivers responded to inquiries or requests, how much time caregivers spent at the patient's bedside, and how many staff were utilized in the care of the patient (including the amount of time for each).
Claims 11-19 are rejected for the same reasons as set forth above with regard to claims 1-9.
Regarding claim 20, Derenne discloses a system for improving medical device performance, the system comprising:
a camera for recording video data of a patient environment, (para. 270, system 20 monitors images and depth readings from cameras 22 to predict behavior that leads to someone getting out of bed.);
at least one processing device, (Fig. 2); and
at least one computer readable data storage device storing software instructions that, when executed by the at least one processing device, (Figures 2-4), cause the at least one processing device to:
identify a caregiver inside the patient environment based on the video data, (para. 173, system 20 is configurable to identify this specific caregiver by means of facial recognition software, a badge identification process based upon a specific badge that caregiver 82 is wearing, an RF ID tag that is worn by caregiver 82, the attire of caregiver 82, and/or a combination of one or more of these means and para. 318, a quality auditing software module 34 that analyzes the quality of care provided to a patient according to a number of different metrics. In some embodiments, authorized personnel at the healthcare institution can custom tailor these metrics to the particular needs of that healthcare institution. In general, such metrics include how well any or all of the healthcare protocols were followed (as detected by system 20), how fast caregivers responded to inquiries or requests, how much time caregivers spent at the patient's bedside, and how many staff were utilized in the care of the patient (including the amount of time for each);
analyze the video data to determine a classification of the caregiver inside the patient environment, (para. 320, System 20 is also configurable in some embodiments to execute a caregiver presence software module 34 that monitors the presence of a healthcare worker within the patient's room and changes one or more conditions automatically based upon the worker's presence); and
adjust operation of at least one medical device based on the classification of the caregiver inside the patient environment, (para. 320, the software module 34 automatically changes what information is displayed on the patient support apparatus 36, or another display in the room, based upon the type of worker enters the room (e.g. technician, cleaning personnel, caregiver, administrator, volunteer, etc.)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
SYSTEM AND METHOD FOR OPTIMIZING CLINICAL FLOW AND OPERATIONAL EFFICIENCIES IN A NETWORK ENVIRONMENT (US 20130304499 A1) teaches optimizing clinical flow and operational efficiencies in a network environment is provided and includes generating a patient care plan for each patient in a medical care facility, generating a patient pathway for each patient, executing the patient care plans and the patient pathways of the respective patients during encounters associated with the respective patients, capturing real time data during the execution of the patient care plans and the patient pathways, performing an analysis on the real time data, and displaying the real time data in a visual display.
VIDEO DATA EXTENSION SYSTEM AND METHOD (US 20140297328 A1) teaches extending mobile video data across multiple display hardware platforms is disclosed. The system incorporates a mobile user interface device (MUD) interacting with a video control unit (VCU) to present display video content (DVC) on a video display unit (VDU).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amber Misiaszek whose telephone number is 571-270-1362. The examiner can normally be reached M-F 8:00-5:30, First Friday Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER A MISIASZEK/Primary Examiner, Art Unit 3682
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