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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/27/26 has been entered.
Response to Amendment
In response to amendments, filed February 27, 2026, claims 1, 8-9, 16, and 21 have been amended. No claim(s) have been further added or cancelled. Claims 1-6 and 8-21 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed February 27, 2026, with respect to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Sidhu (US 20170098359 A1)/Chronis (US 20210007676 A1)/Rush (US 10600204 B1)/Halperin (US 20150164438 A1)/Hood (US 20150281659 A1)/Russek (US 5319355 A).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“locator system” in claims 5 and 9 -- [0069] “The locator system 146 may utilize one or both of the GPS 250 from the remote user device 142 and the transmitters 254 and receivers 252 without departing from the teachings herein.” [0070] “The locator system 146 includes the controller 256, which has a processor, a memory, and other control circuitry.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidhu (US 20170098359 A1) in view of Chronis (US 20210007676 A1) and Rush (US 10600204 B1).
Regarding claim 1, Sidhu teaches a monitoring system for a patient fall risk protocol (exit detection system 56), comprising:
a support apparatus (person support apparatus 20) including a sensor configured to sense a position of a patient (Fig. 4, force sensors 54, a vital sign sensor 60, siderail position sensors 64, siderail force sensors 66, position sensor 68) and a control unit in communication with the sensor, wherein the control unit is configured to:
monitor the position of the patient relative to a monitoring area on the support apparatus ([0063] “In the illustrative example shown in FIG. 5, controller 58 has determined the occupant's center of gravity to be at a location 84. Controller 58 compares this center of gravity 84 to the active one of zones 86 (i.e. the one selected by the user or caregiver) that are defined in reference frame 76 and determines whether the center of gravity 84 is inside or outside of this active zone 86.”); and determine a preliminary fall risk evaluation ([0079] “the default fall risk is set to a high risk of falling… Alternatively, or additionally, controller 58 is programmed in some embodiments to calculate a fall risk based upon one or more medical factors of the occupant, such as whether (and/or how recently) surgery was performed on the occupant, whether (and/or how recently) anesthesia was administered to the occupant, and other factors.”);
an imaging system having an imager defining a field of view that includes the support apparatus ([0082] “controller 58 communicates with an occupant temperature sensor that includes one or more thermal image sensors having fields of view that include the occupant while positioned on the person support apparatus”);
a user interface (user interface 62).
However, Sidhu fails to disclose an imaging system with a field of view that includes monitoring patient movement in the area adjacent to the support apparatus.
Chronis teaches systems and methods for identifying someone intending to leave a bed or chair generally before or shortly after the bed or chair is exited. Chronis discloses an imaging system having an imager defining a field of view that includes the support apparatus and an area adjacent to the support apparatus ([0034] “providing a depth camera for imaging the patient; determining movement specifics of how the patient moves immediately prior to exiting the bed from the bed sensor and the depth camera; based on the movement specifics, evaluating a patient's instantaneous risk of falling after exiting the bed; and if the instantaneous risk is sufficiently high, issuing an alert for the patient.”
[0070] “Prior gait information may have been obtained from sensors such as depth cameras (101) when the patient first entered the room.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sidhu to include an imaging system with a field of view that includes the area adjacent to the support apparatus as disclosed in Chronis to appropriately adjust a patient’s assigned fall risk based on gait improvement, which would allow patients that have improved gait (or returning to normal gait) to potentially be allowed to walk without assistance after sufficient improvement (Chronis [0070]).
The combination of Sidhu/Chronis discloses and a controller in communication with the support apparatus, the imaging system, and the user interface (Sidhu: controller 58; Fig. 4), wherein the controller is configured to:
receive the preliminary fall risk evaluation from the support apparatus (Sidhu: [0079] “Controller 58 is informed of the fall risk assessment of the occupant from either an auxiliary input 70 (e.g. using an auxiliary input 70 to communicate with and EMR server that includes a medical record for the occupant identifying his or her fall risk) or from a caregiver, or other user, entering the occupant's fall risk via user interface 62;”);
determine an overall fall risk evaluation using the preliminary fall risk evaluation; assign a monitoring level for the monitoring area based on the overall risk evaluation (Sidhu: [0079] “controller 58 is programmed in some embodiments to calculate a fall risk based upon one or more medical factors of the occupant, such as whether (and/or how recently) surgery was performed on the occupant, whether (and/or how recently) anesthesia was administered to the occupant, and other factors.” [0080] “Regardless of its source, controller 58 uses the fall risk information to adjust the size of one or more zones 86.”);
monitor movement of the patient in image data received from the imaging system, the movement including when the patient is out of the support apparatus and in the area adjacent to the support apparatus (Chronis: [0070] “Prior gait information may have been obtained from sensors such as depth cameras (101) when the patient first entered the room.” [0084] “the system may detect that they are exiting and detect that they have just hit their cane while getting up and it has moved out of their reach (as indicated by a camera image detecting the movement of the cane, for example).”).
However, the combination of Sidhu/Chronis fails to disclose receiving caregiver feedback related to accuracy or timing of alerts.
Rush teaches methods related to determining changes in orientation of an object with respect to a bed and/or seating platform and issuing electronic communication alerts. Rush discloses receive caregiver feedback from the user interface related to at least one of accuracy and timing of alerts (Col 28, lines 42-48 “the module 116 can cause processor 106 to issue an electronic communication alert that can be accepted or dismissed by the caregiver. For example, if the alert is not valid (e.g., the patient is not actually at risk, the patient has repositioned himself, the patient has been repositioned, etc.), the caregiver can dismiss the alert.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sidhu/Chronis to include receiving caregiver feedback related to accuracy or timing of alerts as disclosed in Rush to increase the accuracy of the risk score and corresponding alert sensitivity level for a patient (Rush Col 28, lines 52-55).
The combination of Sidhu/Chronis/Rush discloses adjust the overall risk evaluation in response to at least one of the caregiver feedback and the movement; and adjust a monitoring level of the monitoring area in response to at least one of changes in the overall fall risk evaluation, the caregiver feedback, and the movement of the patient (Rush: Col 28, lines 48-53 “The module 116 can then cause the processor 106 to incorporate the accepting or dismissal into the module to adjust the base risk score and corresponding alert sensitivity level (e.g., increase or decrease sensitivity) accordingly.” Sidhu: [0080] “Regardless of its source, controller 58 uses the fall risk information to adjust the size of one or more zones 86;” [0082] “controller 58 expands the size of one or more zones 86 in response to a decrease in the occupant's temperature, such as may occur while the occupant is asleep. In such embodiments, controller 58 reduces the size of the one or more zones 86 in response to an increase in the occupant's temperature… controller 58 communicates with an occupant temperature sensor that includes one or more thermal image sensors having fields of view that include the occupant while positioned on the person support apparatus;” [0109] “principles disclosed herein can be applied to a video image based exit detection system wherein an exit alert is issued if the position of the occupant meets one or more criteria (e.g. the occupant moves to within X distance of a side of person support apparatus 20).” Chronis: [0070] “This patient may have different fall risk assigned as the system assesses their gait upon arrival compared to a gait when they were last assisted in walking to determine how well they are improving and if their risk should be lowered the next time they get up.” [0084] “if a patient at a low calculated risk of fall is attempting a bed exit and the nature of the exit indicates that there is a heightened risk at this particular time, that may also trigger an alert. … The detected movement of the cane away from them may trigger an alert for this patient for this particular bed exit notifying that patient not to attempt to get their cane and that a nurse is on their way to help them.”).
Regarding claim 2, the combination of Sidhu/Chronis/Rush discloses the monitoring system of claim 1, wherein the control unit is configured to communicate the position of the patient to the controller when the position is at least partially outside a boundary of the monitoring area, and wherein the controller is configured to generate an alert notification in response to the position of the patient being at least partially outside of the boundary of the monitoring area (Sidhu: [0063] “In the illustrative example shown in FIG. 5, controller 58 has determined the occupant's center of gravity to be at a location 84. Controller 58 compares this center of gravity 84 to the active one of zones 86 (i.e. the one selected by the user or caregiver) that are defined in reference frame 76 and determines whether the center of gravity 84 is inside or outside of this active zone 86. If center of gravity 84 moves outside of the active zone 86 (discussed below), controller 58 issues an alert”).
Regarding claim 3, the combination of Sidhu/Chronis/Rush discloses the monitoring system claim 2, wherein the controller is configured to adjust the monitoring level to decrease a size of the monitoring area within the boundary and increase a sensitivity for a fall risk routine of the controller to adjust when the controller is configured to generate the alert notification (Sidhu: [0080] “In some embodiments, controller 58 shrinks the size of the zone(s) 86 in response to greater fall risks and expands the size of the zone(s) 86 in response to smaller fall risks. In these embodiments, an occupant who is at a high risk of falling will trigger an exit alert with less motion than an occupant who is at a low risk of falling.”).
Regarding claim 4, the combination of Sidhu/Chronis/Rush discloses the monitoring system of claim 2, wherein the controller is configured to adjust the monitoring level to increase a size of the monitoring area within the boundary and decrease a sensitivity for a fall risk routine of the controller to adjust when the controller is configured to generate the alert notification (Sidhu: [0080] “In some embodiments, controller 58 shrinks the size of the zone(s) 86 in response to greater fall risks and expands the size of the zone(s) 86 in response to smaller fall risks. In these embodiments, an occupant who is at a high risk of falling will trigger an exit alert with less motion than an occupant who is at a low risk of falling.”).
Regarding claim 5, the combination of Sidhu/Chronis/Rush discloses the monitoring system of claim 1, wherein the controller is configured to:
receive a caregiver location from a caregiver locator system; and adjust the overall fall risk evaluation in response to the caregiver location (Sidhu: [0098] “caregiver proximity information is communicated to controller 58, controller 58 uses this information to make an adjustment in the size and/or shape of at least one zone 86 in response to a caregiver being within a threshold distance to person support apparatus 20 (e.g. within the same room) and in response to the caregiver being outside of the threshold distance (e.g. outside of the same room).”).
Regarding claim 6, the combination of Sidhu/Chronis/Rush discloses the monitoring system of claim 1, wherein the controller is configured to:
retrieve patient information from an electronic medical record, wherein the patient information includes at least one of a fall risk assessment, vital signs information, and medication information; and adjust the overall fall risk evaluation in response to the patient information (Sidhu: [0059] “inputs 70 may communicate with an Electronic Medical Record (EMR) system;” [0079] “Controller 58 is informed of the fall risk assessment of the occupant from either an auxiliary input 70 (e.g. using an auxiliary input 70 to communicate with and EMR server that includes a medical record for the occupant identifying his or her fall risk);” [0079] “controller 58 is programmed in some embodiments to calculate a fall risk based upon one or more medical factors of the occupant, such as whether (and/or how recently) surgery was performed on the occupant, whether (and/or how recently) anesthesia was administered to the occupant, and other factors.” [0080] “Regardless of its source, controller 58 uses the fall risk information to adjust the size of one or more zones 86.” [0081] “controller 58 is programmed to automatically shrink one or more zones 86 in response to an increase in the occupant's breathing rate, pulse rate, and/or heart rate, and to expand one or more zones 86 in response to a decrease in the occupant's breathing rate, pulse rate, and/or heart rate.”).
Regarding claim 8, the combination of Sidhu/Chronis/Rush discloses the monitoring system of claim 1, wherein the support apparatus includes bed sensors configured to sense at least one of a position of segments of the support apparatus, a height of the support apparatus relative to an underlying floor surface, and a siderail position (Siderail position sensors 64; Siderail force sensors 66; Position sensor 68), and
wherein the controller is configured to determine patterns in sensed patient information and sensed information from the bed sensors and adjust the overall fall risk evaluation in response to the sensed information from the bed sensors (Sidhu: [0080] “Regardless of its source, controller 58 uses the fall risk information to adjust the size of one or more zones 86;” [0086] “changes in size and shape illustrated in FIGS. 6-8 are merely one example of the types of changes that may be implemented by controller 58 in response to the movement of the siderails 36;” [0092] “Controller 58 is informed of the position of one or more other components of person support apparatus 20 by way of one or more of the position sensors 68. Controller 58 adjusts the size and/or shape of one of the zones 86 in response to changes in the position of one or more components (or the occupant) that meet one or more criteria.” Chronis: [0085] “if a patient at low risk suddenly has a very different sitting up pattern or a different sit-to-stand pattern, this may trigger an alert as something may have happened to the patient in bed. For example if a patient is suddenly using their hands to swing a leg around having never done that before (as detected by a bed sensor or thermal imaging, for example) the system may trigger an alert to nursing personnel.”).
Claim(s) 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidhu (US 20170098359 A1) in view of Halperin (US 20150164438 A1) and Rush (US 10600204 B1).
Regarding claim 9, Sidhu discloses a fall risk monitoring system for a medical facility (Sidhu: exit detection system 56), comprising:
a support apparatus (Sidhu: person support apparatus 20) including:
a sensor configured to sense patient information related to a patient on the support apparatus (Sidhu: Fig. 4, force sensors 54, a vital sign sensor 60, siderail position sensors 64, siderail force sensors 66, position sensor 68); and
a control unit configured to monitor the sensed patient information from the sensor relative to a monitoring trigger (Sidhu: [0063] “In the illustrative example shown in FIG. 5, controller 58 has determined the occupant's center of gravity to be at a location 84. Controller 58 compares this center of gravity 84 to the active one of zones 86 (i.e. the one selected by the user or caregiver) that are defined in reference frame 76 and determines whether the center of gravity 84 is inside or outside of this active zone 86.”);
a locator system configured to determine a location of a caregiver in said medical facility (Sidhu: [0096] “Controller 58 is informed of the proximity of a caregiver via the addition of a sensor to person support apparatus 20 that detects badges worn by caregivers (when the caregivers are within a defined range of the person support apparatus 20), and/or via information received from another sensor (or set of sensors) that communicates with person support apparatus 20 via one or more of the auxiliary inputs 70”); and
a controller in communication with the support apparatus and the locator system (Sidhu: controller 58, Fig. 4), wherein the controller is configured to:
determine a monitoring level for the monitoring trigger based on a fall risk evaluation (Sidhu: [0080] “Regardless of its source, controller 58 uses the fall risk information to adjust the size of one or more zones 86”);
receive data from the support apparatus related to the patient and the support apparatus; receive the location of the caregiver (Sidhu: [0092] “Controller 58 is informed of the position of one or more other components of person support apparatus 20 by way of one or more of the position sensors 68;” [0098] “caregiver proximity information is communicated to controller 58,”).
However, Sidhu fails to disclose a predicted time for the caregiver to reach a room with the support apparatus.
Halperin teaches a patient-monitoring system, including a clinical sensor, configured to measure a clinical parameter of a patient, and to generate a clinical-sensor signal in response thereto. Halperin discloses: determine a predicted time for the caregiver to reach a room with the support apparatus from the location (Halperin: [0081] “in response to the respective locations of the clinicians, calculating respective estimated times for the clinicians to reach the patient;” [0219] “Typically, the estimated times are computed by taking into account the respective walking distances of the clinicians from the patient. In other words, the control unit takes into account the location of each clinician and the layout of the hospital corridors, such that the estimated time for a particular clinician reflects the distance that the clinician would need to travel to reach the patient. Furthermore, the control unit may also calculate the respective estimated times in response to times that were historically required to traverse portions of the hospital.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sidhu to include a predicted time for the caregiver to reach a room with the support apparatus as disclosed in Halperin to designate a subset of the plurality of clinicians based on the estimated arrival times for improved responsiveness and quality of patient treatment (Halperin [0082, 0186]).
The combination of Sidhu/Halperin discloses: and adjust the monitoring level of the monitoring trigger in response to at least one of the data from the support apparatus, the location of the caregiver, and the predicted time (Sidhu: [0092] “Controller 58 adjusts the size and/or shape of one of the zones 86 in response to changes in the position of one or more components (or the occupant) that meet one or more criteria.” [0098] “caregiver proximity information is communicated to controller 58, controller 58 uses this information to make an adjustment in the size and/or shape of at least one zone 86 in response to a caregiver being within a threshold distance to person support apparatus 20 (e.g. within the same room) and in response to the caregiver being outside of the threshold distance (e.g. outside of the same room) [or the threshold being based on estimated time for the clinician to reach the patient per Halperin].”); generate an alert in response to the sensed patient information relative to the monitoring trigger (Sidhu: [0015] “The exit detection system is adapted to issue an alert if the occupant of the person support apparatus moves in a manner that meets a set of criteria”).
However, the combination of Sidhu/Halperin fails to disclose receiving caregiver feedback related to accuracy or timing of alerts.
Rush discloses receive feedback from a caregiver related to at least one of accuracy and timing of the alert; and adjust the monitoring level of the monitoring area in response to feedback (Col 28, lines 39-52 “In one or more implementations, the system 100 may utilize suitable machine learning techniques to adjust the sensitivity level of the electronic communication alerts in response to caregiver feedback. For instance, the module 116 can cause processor 106 to issue an electronic communication alert that can be accepted or dismissed by the caregiver. For example, if the alert is not valid (e.g., the patient is not actually at risk, the patient has repositioned himself, the patient has been repositioned, etc.), the caregiver can dismiss the alert. The module 116 can then cause the processor 106 to incorporate the accepting or dismissal into the module to adjust the base risk score and corresponding alert sensitivity level (e.g., increase or decrease sensitivity) accordingly.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sidhu/Halperin to include receiving caregiver feedback related to accuracy or timing of alerts as disclosed in Rush to increase the accuracy of the risk score and corresponding alert sensitivity level for a patient (Rush Col 28, lines 52-55).
Regarding claim 10, the combination of Sidhu/Halperin/Rush discloses the fall risk monitoring system of claim 9, wherein the monitoring trigger is a boundary around a monitoring area on the support apparatus, wherein the sensor is configured to sense a center of gravity of the patient (Sidhu: [0063] “In the illustrative example shown in FIG. 5, controller 58 has determined the occupant's center of gravity to be at a location 84. Controller 58 compares this center of gravity 84 to the active one of zones 86 (i.e. the one selected by the user or caregiver) that are defined in reference frame 76 and determines whether the center of gravity 84 is inside or outside of this active zone 86.”).
Regarding claim 11, the combination of Sidhu/Halperin/Rush discloses the fall risk monitoring system of claim 10, wherein the control unit is configured to monitor the center of gravity relative to the boundary, and wherein the controller is configured to generate an alert notification when the center of gravity is at least partially outside the boundary of the monitoring area (Sidhu: [0063] “In the illustrative example shown in FIG. 5, controller 58 has determined the occupant's center of gravity to be at a location 84. Controller 58 compares this center of gravity 84 to the active one of zones 86 (i.e. the one selected by the user or caregiver) that are defined in reference frame 76 and determines whether the center of gravity 84 is inside or outside of this active zone 86.”).
Regarding claim 12, the combination of Sidhu/Halperin/Rush discloses the fall risk monitoring system of claim 9, wherein the monitoring trigger is a movement threshold and the sensor is configured to sense movement of the patient on the support apparatus, and wherein the controller is configured to generate an alert notification when the sensed movement of the patient exceeds the movement threshold (Sidhu: [0064] “Zones 86a, b, and c have different sizes, allowing the occupant to engage in different amounts of movement prior to triggering an exit alert. When exit detection system 56 is in use, a user selects which one of the zones 86a-c will be the active zone using user interface 62. Controller 58 then repetitively recalculates the occupant's center of gravity based upon the outputs from force sensors 54 and compares the calculated center of gravity 84 to the active zone. If the center of gravity 84 is within the active zone 86, no exit alert is issued. If the center of gravity 84 moves outside of the active zone 86, controller 58 issues an alert.”).
Regarding claim 13, the combination of Sidhu/Halperin/Rush discloses the fall risk monitoring system of claim 9, wherein the monitoring trigger is an area within a predefined distance from a side of the support apparatus, wherein the sensor is configured to sense a position of the patient and the control unit is configured to monitor the position of the patient relative to the area within the predefined distance from the side of the support apparatus, and wherein the controller is configured to generate an alert notification when the sensed position of the patient is sensed within the area (Sidhu: [0064] “Zones 86a, b, and c have different sizes, allowing the occupant to engage in different amounts of movement prior to triggering an exit alert. When exit detection system 56 is in use, a user selects which one of the zones 86a-c will be the active zone using user interface 62. Controller 58 then repetitively recalculates the occupant's center of gravity based upon the outputs from force sensors 54 and compares the calculated center of gravity 84 to the active zone. If the center of gravity 84 is within the active zone 86, no exit alert is issued. If the center of gravity 84 moves outside of the active zone 86, controller 58 issues an alert.” [0109] “principles disclosed herein can be applied to a video image based exit detection system wherein an exit alert is issued if the position of the occupant meets one or more criteria (e.g. the occupant moves to within X distance of a side of person support apparatus 20).”).
Regarding claim 14, the combination of Sidhu/Halperin/Rush discloses the fall risk monitoring system of claim 9, wherein the patient information includes at least one of movement of the patient, bed exit attempts, and a center of gravity of the patient (Sidhu: [0064] “Controller 58 then repetitively recalculates the occupant's center of gravity based upon the outputs from force sensors 54 and compares the calculated center of gravity 84 to the active zone.”).
Regarding claim 15, the combination of Sidhu/Halperin/Rush discloses the fall risk monitoring system of claim 9, wherein the support apparatus includes a bed sensor configured to sense bed information, wherein the bed information includes at least one head end position, bed height, and siderail positions (Siderail position sensors 64; Siderail force sensors 66; Position sensor 68), and wherein the controller is configured to adjust the monitoring level of the monitoring trigger in response to the bed information (Sidhu: [0086] “changes in size and shape illustrated in FIGS. 6-8 are merely one example of the types of changes that may be implemented by controller 58 in response to the movement of the siderails 36;” [0092] “Controller 58 is informed of the position of one or more other components of person support apparatus 20 by way of one or more of the position sensors 68. Controller 58 adjusts the size and/or shape of one of the zones 86 in response to changes in the position of one or more components (or the occupant) that meet one or more criteria.”).
Claim(s) 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidhu (US 20170098359 A1) in view of Chronis (US 20210007676 A1) and Hood (US 20150281659 A1).
Regarding claim 16, Sidhu teaches an adaptive patient monitoring system (exit detection system 56), comprising:
a support apparatus having sensors (person support apparatus 20; Siderail position sensors 64; Siderail force sensors 66; Position sensor 68);
a server storing an electronic medical record ([00079] “using an auxiliary input 70 to communicate with and EMR server that includes a medical record for the occupant”); and
a controller in communication with the support apparatus and the server (controller 58; Fig. 4), wherein the controller is configured to:
receive information from the support apparatus relating to at least one of the support apparatus and a person on the support apparatus; receive data from the electronic medical record related to the person ([0092] “Controller 58 is informed of the position of one or more other components of person support apparatus 20 by way of one or more of the position sensors 68;” [0079] “Controller 58 is informed of the fall risk assessment of the occupant from either an auxiliary input 70 (e.g. using an auxiliary input 70 to communicate with and EMR server that includes a medical record for the occupant identifying his or her fall risk);” [0081] “Controller 58 is informed of the vital sign readings from vital sign sensor 60 and/or one or more vital sign sensors that communicate with controller 58 via one or more auxiliary inputs 70”);
determine a monitoring level of a monitoring area on the support apparatus ([0080] “Regardless of its source, controller 58 uses the fall risk information to adjust the size of one or more zones 86”).
However, Sidhu fails to disclose capturing movement of the person when the person is out of the support apparatus.
Chronis discloses communicate with an imaging system configured to capture image data of movement of the person when the person is out of the support apparatus ([0034] “providing a depth camera for imaging the patient; … based on the movement specifics, evaluating a patient's instantaneous risk of falling after exiting the bed; and if the instantaneous risk is sufficiently high, issuing an alert for the patient.” [0070] “Prior gait information may have been obtained from sensors such as depth cameras (101) when the patient first entered the room.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sidhu to capturing movement of the person when the person is out of the support apparatus as disclosed in Chronis to include appropriately adjust a patient’s assigned fall risk based on gait improvement, which would allow patients that have improved gait (or returning to normal gait) to potentially be allowed to walk without assistance after sufficient improvement (Chronis [0070]).
The combination of Sidhu/Chronis discloses and adjust the monitoring level in response to at least one of the information from the support apparatus, the data from the electronic medical record, and the image data (Sidhu: [0092] “Controller 58 adjusts the size and/or shape of one of the zones 86 in response to changes in the position of one or more components (or the occupant) that meet one or more criteria.” Figs. 6-8; [0081] “controller 58 is programmed to automatically shrink one or more zones 86 in response to an increase in the occupant's breathing rate, pulse rate, and/or heart rate, and to expand one or more zones 86 in response to a decrease in the occupant's breathing rate, pulse rate, and/or heart rate.” Chronis: [0070] “a patient who is pregnant at admittance would likely have an increased fall risk (and different gait) than the same patient multiple days after giving birth (e.g. at discharge) but may have a decreased fall risk (and different gait) compared to the same patient in the immediate hours after giving birth when anesthesia may be wearing off. This patient may have different fall risk assigned as the system assesses their gait upon arrival compared to a gait when they were last assisted in walking to determine how well they are improving and if their risk should be lowered the next time they get up.” [0084] “if a patient at a low calculated risk of fall is attempting a bed exit and the nature of the exit indicates that there is a heightened risk at this particular time, that may also trigger an alert. For example, a patient in a sing home may regularly walk with a cane and is deemed to be at low risk if they use the cane. However, the system may detect that they are exiting and detect that they have just hit their cane while getting up and it has moved out of their reach (as indicated by a camera image detecting the movement of the cane, for example). The detected movement of the cane away from them may trigger an alert for this patient for this particular bed exit notifying that patient not to attempt to get their cane and that a nurse is on their way to help them.”).
However, the combination of Sidhu/Chronis fails to disclose the support apparatus having a pneumatic system. Hood teaches a patient bed and a camera system that provides a picture of video to a caregiver display in response to a triggering event.
Hood discloses the support apparatus having a pneumatic system (pneumatic system 72); wherein the controller is configured to: adjust the monitoring level in response to an activated therapy provided by the pneumatic system ([0039] “In some embodiments, operation of any one or more of actuators 70, 90, 92, 94, 96 constitutes a bed event that results in video images captured by camera 14 being recorded and/or transmitted to caregiver display 22. The same goes for operation of pneumatic system 72 to initiate a therapy, for example, such as rotation therapy, percussion therapy, alternating pressure therapy, and the like.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sidhu/Chronis to include adjusting the monitoring level in response to an active pneumatic system as disclosed in Hood to provide therapy while reducing patient falls and reducing false alarms by directly observing the patient via the video feed (Hood [0039, 0052]).
Regarding claim 17, the combination of Sidhu/Chronis/Hood discloses the adaptive patient monitoring system claim 16, wherein the monitoring level is adjusted from an initial boundary of the monitoring area to a subsequent boundary of the monitoring area, wherein the monitoring area in the subsequent boundary is smaller than the monitoring area in the initial boundary to increase a sensitivity of a fall risk protocol to adjust when the controller is configured to generate an alert notification in response to a patient being outside the monitoring area (Sidhu: [0080] “In some embodiments, controller 58 shrinks the size of the zone(s) 86 in response to greater fall risks and expands the size of the zone(s) 86 in response to smaller fall risks. In these embodiments, an occupant who is at a high risk of falling will trigger an exit alert with less motion than an occupant who is at a low risk of falling.”).
Regarding claim 18, the combination of Sidhu/Chronis/Hood discloses the adaptive patient monitoring system of claim 16, wherein the controller is configured to: monitor patient movement on the support apparatus based on the image data from the imaging system; and adjust the monitoring level in response to the patient movement on the support apparatus (Sidhu: [0082] “controller 58 expands the size of one or more zones 86 in response to a decrease in the occupant's temperature, such as may occur while the occupant is asleep. In such embodiments, controller 58 reduces the size of the one or more zones 86 in response to an increase in the occupant's temperature… controller 58 communicates with an occupant temperature sensor that includes one or more thermal image sensors having fields of view that include the occupant while positioned on the person support apparatus;” [0109] “principles disclosed herein can be applied to a video image based exit detection system wherein an exit alert is issued if the position of the occupant meets one or more criteria (e.g. the occupant moves to within X distance of a side of person support apparatus 20).”).
Regarding claim 20, the combination of Sidhu/Chronis/Hood discloses the adaptive patient monitoring system of claim 16, wherein the controller is configured to:
determine a fall risk evaluation (Sidhu: [0079] “the default fall risk is set to a high risk of falling.”);
adjust the fall risk evaluation in response to at least one of the information from the support apparatus and the data from the electronic medical record (Sidhu: [0079] “Alternatively, or additionally, controller 58 is programmed in some embodiments to calculate a fall risk based upon one or more medical factors of the occupant, such as whether (and/or how recently) surgery was performed on the occupant, whether (and/or how recently) anesthesia was administered to the occupant, and other factors.);
and dynamically adjust the monitoring level in response to the updated fall risk evaluation (Sidhu: [0092] “Controller 58 adjusts the size and/or shape of one of the zones 86 in response to changes in the position of one or more components (or the occupant) that meet one or more criteria. Figs. 6-8; [0081] controller 58 is programmed to automatically shrink one or more zones 86 in response to an increase in the occupant's breathing rate, pulse rate, and/or heart rate, and to expand one or more zones 86 in response to a decrease in the occupant's breathing rate, pulse rate, and/or heart rate.” [0080] “Regardless of its source, controller 58 uses the fall risk information to adjust the size of one or more zones 86).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidhu (US 20170098359 A1) in view of Chronis (US 20210007676 A1) and Hood (US 20150281659 A1), and in further view of Russek (US 5319355 A).
Regarding claim 19, the combination of Sidhu/Chronis/Hood discloses the adaptive patient monitoring system of claim 16. However, the combination of Sidhu/Chronis/Hood fails to disclose facility code information. Russek teaches an alarm system for notifying necessary medical and hospital personnel that a patient or the patient's life support equipment require immediate response. Russek discloses wherein the controller is configured to receive facility code information from an emergency coding system (Russek: Col 7, line 55 - Col 8, line 1, “The alarm signal pulse generator 12 takes the status output signal from the equipment monitor sensor 10 and converts that signal into a coded pulse that identifies the patient, the room, the ambulance or other relevant location information. The equipment type for which sensor 10 denotes a problem is also identified along with readings from the equipment… The output of the alarm signal pulse generator 12 may be communicated through a conventional electric wire or optical cable to the master alarm control 14 typically located at a nurse's station. Alternatively, communications from generator 12 can be RF-based through conventional RF emergency bands (such as those designated for ambulances) or for emergency medical personnel.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sidhu/Chronis/Hood to include facility code information as disclosed in Russek to arrange to provide programmable control for scheduling and prioritizing communications in accordance with the staffing realities of the hospital so that speed, privacy, and efficiency are maximized (Russek Col 9, 17-27).
The combination of Sidhu/Chronis/Hood/Russek and adjust the monitoring level of the monitoring area in response to a current code status at a location separate from a location where the support apparatus for the person is located (Russek: Col 9, lines 28-36 “The information provided includes the names of hospital staff assigned to each patient, to each room, and to each type of medical condition as well as the availability of those individuals to respond to emergency calls. Thus, if the doctor assigned to the patient is attending to another emergency, the system flexibly assigns an alternate doctor who is available and/or who specializes in the condition indicated by the equipment.” Sidhu: [0098] “caregiver proximity information is communicated to controller 58, controller 58 uses this information to make an adjustment in the size and/or shape of at least one zone 86 in response to a caregiver being within a threshold distance to person support apparatus 20 (e.g. within the same room) and in response to the caregiver being outside of the threshold distance (e.g. outside of the same room).”).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidhu (US 20170098359 A1) in view of Chronis (US 20210007676 A1) and Hood (US 20150281659 A1), and in further view of Halperin (US 20150164438 A1).
Regarding claim 21, the combination of Sidhu/Chronis/Hood discloses the adaptive patient monitoring system of claim 16, wherein the controller is configured to: communicate with a locator system (Sidhu: [0096] “Controller 58 is informed of the proximity of a caregiver via the addition of a sensor to person support apparatus 20 that detects badges worn by caregivers (when the caregivers are within a defined range of the person support apparatus 20), and/or via information received from another sensor (or set of sensors) that communicates with person support apparatus 20 via one or more of the auxiliary inputs 70”). However, the combination of Sidhu/Chronis/Hood fails to disclose a predicted time for the caregiver to reach a room with the support apparatus.
Halperin discloses determine a predicted time for the caregiver to reach a room with the support apparatus from a location determined by the locator system (Halperin: [0081] “in response to the respective locations of the clinicians, calculating respective estimated times for the clinicians to reach the patient;” [0219] “Typically, the estimated times are computed by taking into account the respective walking distances of the clinicians from the patient. In other words, the control unit takes into account the location of each clinician and the layout of the hospital corridors, such that the estimated time for a particular clinician reflects the distance that the clinician would need to travel to reach the patient. Furthermore, the control unit may also calculate the respective estimated times in response to times that were historically required to traverse portions of the hospital.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sidhu/Chronis/Hood to include a predicted time for the caregiver to reach a room with the support apparatus as disclosed in Halperin to designate a subset of the plurality of clinicians based on the estimated arrival times for improved responsiveness and quality of patient treatment (Halperin [0082, 0186]).
The combination of Sidhu/Chronis/Hood/Halperin disclose and adjust the monitoring level of the monitoring trigger in response to the predicted time (Sidhu: [0098] “caregiver proximity information is communicated to controller 58, controller 58 uses this information to make an adjustment in the size and/or shape of at least one zone 86 in response to a caregiver being within a threshold distance to person support apparatus 20 (e.g. within the same room) and in response to the caregiver being outside of the threshold distance (e.g. outside of the same room).” – the distance threshold corresponding to the respective estimated times for the clinicians to reach the patient per Halperin [0081]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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