DETAILED ACTION
This action is in reference to the communication filed on 27 JAN 2025.
Claims 1-15 are present and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 15 (as well as claim 2) recite the term “degree of loads” and/or “degree of allowable loads.” Examiner finds the term “degree” to be indefinite. Examiner understands the “loads” to generally represent patients in a care setting. However, it is unclear if the term degree is representative of the severity of the load, or the numerical total of the load(s) – i.e. the relationship between the relative severity of a patient(s) condition, or the total number of patients allowed in a given setting.
Much of the specification refers to these two terms without defining them including [067], as well as figure 5 and related text. [093] indicates that the degree is determined using “past records” and multiplying the obtained value by the number of caregivers on duty, without identifying the past records. [095] indicates a relationship between a ward load and allowable load changing the time that a caregiver has to respond, but also may be used to determine a caregiver has room for “additional care,” lending to the interpretation of “total number of patients.” [0112] discusses a “degree of priority” as a degree of urgency, which could be applied to either a severity or a numerical case load. [0114] indicates that a patient load is determined on a per-patient basis, and [0119] discusses a “degree of the risk of falling” – i.e. perhaps indicating a severity consideration, however, neither of those are the degree of load/allowable load. [fig 8 and related text] discloses using individual severity/risks to create a load index, however it is again unclear how this relates or factors into a degree therein. Defining this term in the claim is particularly important given the limitations about a target time in responding – if the degree represent the severity of an individual(s) condition, the target response time might be different than if the degree represented a higher or lower total caseload for a caregiver. Moreover, those two relationships are not immediately interchangeable or linear. As such the scope of the claims is indefinite.
Claim 11-13 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 11-13 recites the limitation “the condition recommended.” Claims 12-13 depend on claim 11, which depends from claim 1. Claim 1 recites “a condition,” but does not recite “a condition recommended.” Therefore, there is insufficient antecedent basis for this limitation in the claim.
Claim Objections
Claims 9, 10 appear to have a grammatical error – the claim recites “ configured to determines,” Examiner believes the intention is for these claims to read “configured to determine”
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 1-15 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-15 the independent claim(s) (1, 15) recite(s) a system and a method, each of which is a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-15 the independent claim(s) (1, 15), the pr is/are directed, in part, to (excluding the additional elements in strikethrough):
An information processing system comprising:
obtain a first information indicating a degree of loads needed for the caregiver to deal with the notification processing on per-hospital ward basis, if the notification processing is executed, and
obtain a second information indicating a degree of allowable loads, based on a third information indicating a target time in dealing with the notification processing and the number of the caregivers to deal with the notification processing, and
These claim elements are considered to be abstract ideas because they are directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Processing notifications, obtaining first and second information including a third information of a target time, and processing based on a allowable loads, are all similar concepts. If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category.
The claims are further directed to a method of organizing human activity which include managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Processing information between a caregiver and the allowable loads is an example of relationships between people, i.e. the caregiver and the loads/patients. If a claim limitation, under its broadest reasonable interpretation, covers commercial and legal interactions, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements: Claim 1 recites a “controller,” and both claims 1, 15 recite, respectively, “display configured to display a setting screen” and “processing of displaying, on a display, a setting screen.” In the interest of compact prosecution, Examiner notes that if assuming the controller of claim 1 and the “processing” of claim 15 to recite a computing element, it is at best recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). Examiner finds no improvement to the functioning of the computer or any other technology or technical field in the above identified elements as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). As per the displays common to both claims, Examiner finds that the display of information on a screen/display (and any associated sending/receiving of data) is generally considered to be analogous adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g).
Accordingly, this/these additional element(s) do(es) 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.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as: Claim 1 recites a “controller,” and both claims 1, 15 recite, respectively, “display configured to display a setting screen” and “processing of displaying, on a display, a setting screen.” When considered individually, the identified claim elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0250] …controller (control box) provided with a processor that controls the same and a memory. This controller may also function as the terminal device 300 of this embodiment.
[0052] The terminal device 300 is a device to be used by a caregiver, for example. Specifically, the terminal device 300 is a device supplied to each of multiple caregivers, and is configured to perform processing of presenting the caregiver with various kinds of information on a patient acquired from the information processor 200. Note that, the terminal device 300 and the bed 100 do not necessarily have to be provided separately. As will be described later, the terminal device 300 may be incorporated in the bed 100.
[0054] FIG. 2 is a diagram illustrating the functional configuration of the information processing system 10. The information processing system 10 includes: the sensing device 500; the information processor 200; and the terminal device 300. The information processor 200 includes: a notification setting unit 210; a display processor 220; a notification determination unit 230; a notification unit 240; a memory 250; and a display 260. The terminal device 300 includes a display 310 and a notification section 320. However, the configuration of each of the devices of the information processing system 10 is not limited to the example of FIG. 2, and can be modified such as omitting a part of the configuration or adding a different configuration.
[0058] The display processor 220 is configured to perform processing of displaying, on the display, a setting screen which is a screen for setting the notification conditions. The setting screen will be described in detail later using FIG. 17. Note that, the display mentioned here may be the display 260 of the information processor 200 or may be the display 310 of the terminal device 300.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. Even assuming arguendo, the computing applicability of the controller and associated computing elements, as well as the display, they are both recited at a high level of generality – i.e. any device capable of executing is suitable. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-14:
Dependent claims 2-14 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as means of collecting the data used to determine first and second information, as well as updating the first and second information and different types of interactions executed on the display to set or modify the conditions. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dyell et al (US 20230363678 A1, hereinafter Dyell) in view of Neubauer (US 20230005357 A1).
In reference to claim 1, 15:
Dyell teaches: An information processing system comprising:
An information processing method comprising:
a controller configured to set a condition for executing a notification processing related to a patient to a caregiver, the controller being configured to execute the notification processing if the condition is satisfied (at least [1, 2 and related text including 053-055] “Assume that medical device 16 substantially continuously measures the patient's blood pressure. A blood pressure reading at 8:16 AM indicates 130/90 mm Hg; at 8:20 AM indicates 120/80 mm Hg; and at 8:24 AM indicates 115/65 mmHg. Medical device model 28 corresponding to medical device 16 may specify that any blood pressure measurement over 120/80 mm Hg should generate an alarm. Patient condition 32 may specify that blood pressure for patients with a “serious” designation typically can vary beyond the normal range, but the rate of change is to be monitored more closely…. Alarm condition calculator 42 generates alarm condition 44 based on information from medical device database 20, patient conditions database 22 and user fatigue calculated by alarm fatigue calculator 40, and communicates alarm condition 44 to an adapter 46 located at medical device 16. Adapter 46 monitors and filters alarms from medical device 16. In the example, alarms may not be generated at medical device 16 for blood pressure readings at 8:16 AM and 8:20 AM; however, alarms may be generated at 8:24 AM in view of the rate of change of blood pressure.” See also [089-091] for further discussion of conditional notifications based on overall condition and specific vital sign);
a display configured to display a setting screen used for setting of the notification processing by controlling the controller (at least [fig 1 and related text] user device 14 is a computer logged into by the nursing staff of the hospital used to interact with notification(s)), wherein the controller is configured to:
obtain a first information indicating a degree of loads needed for the caregiver to deal with the notification processing on per-hospital ward basis, if the notification processing is executed (at least [fig 1 and related text, including 051-053] “Nurse Bob logs into an electronic chart at the patient's bedside and enters information about medications being provided to the patient into the electronic chart. Information entered by nurse Bob along with nurse Bob's credentials are sent to alarm management engine 12. Assume that Nurse Bob is set to end his shift at 9:00 AM after 8 hours of continuous work at the ICU. Alarm fatigue calculator 40 calculates nurse Bob's user fatigue at level V (e.g., highest level) at the time of last receipt of status data 27 based on user fatigue model 24 and user fatigue model attribute 26 determined from status data 27… Assume that medical device 16 substantially continuously measures the patient's blood pressure. A blood pressure reading at 8:16 AM indicates 130/90 mm Hg; at 8:20 AM indicates 120/80 mm Hg; and at 8:24 AM indicates 115/65 mmHg. Medical device model 28 corresponding to medical device 16 may specify that any blood pressure measurement over 120/80 mm Hg should generate an alarm. Patient condition 32 may specify that blood pressure for patients with a “serious” designation typically can vary beyond the normal range, but the rate of change is to be monitored more closely.” – i.e. the threshold for the alarm changes based on the “condition” of the patient as described in [029]), and
obtain a second information indicating a degree of allowable loads (at least [fig 1 and related text including [051-054] “…consider a hypothetical intensive care unit (ICU) of a hospital, which is manned by two nurses, Alice and Bob. At 8:00 AM, nurse Alice logs into user device 14 (e.g., computer) at a central hub in the ICU to begin her day's shift. Status data 27 logs the time of entry and communicates it with Nurse Alice's credentials to alarm management engine 12. Alarm fatigue calculator 40 calculates nurse Alice's user fatigue at level I (e.g., lowest level) based on user fatigue model 24 and user fatigue model attribute 26 determined from status data 27..Assume that Nurse Bob is set to end his shift at 9:00 AM after 8 hours of continuous work at the ICU. Alarm fatigue calculator 40 calculates nurse Bob's user fatigue at level V (e.g., highest level)… Patient condition 32 may specify that blood pressure for patients with a “serious” designation typically can vary beyond the normal range, but the rate of change is to be monitored more closely. Further in view of Bob's inferred high user fatigue level, generation of alarms may be tempered to only the more significant ones. …. In some embodiments, alarms may be generated at 8:16 AM and communicated to nurse Alice's work station, as nurse Alice has a lower inferred fatigue level than nurse Bob, but not displayed visibly or audibly at nurse Bob's work station, whereas alarms generated at 8:24 AM may be communicated to both nurse Alice and nurse Bob.” – i.e. based on Bob’s fatigue, the allowable load is different from Alice’s) , and
the display is configured to display information indicating relationship between the first information and the second information in the setting screen (at least [054] based on the examples above, a notification is sent to either Alice, Bob, via user device 14/workstation, or both of them while on duty based on the threshold and fatigue).
Dyell as cited teaches all the limitations above, and further teaches at least applicability of a response time and staffing to determine a condition/threshold for a notification. However, Dyell does not specifically disclose an allowable load based on target time and number of caregivers. Neubauer however does teach: [determining] a degree of allowable loads, based on a third information indicating a target time in dealing with the notification processing and the number of the caregivers to deal with the notification processing (at least [fig 9 and related text], as well as [0171- 0173 including Table 10 and related text] at [fig 9] an alarm is received; and assigned a “sub priority” at 910 based on [figs 3a/3b and related text], and begins the process of assigning the alarm based on the “dynamic attributes” of staff members, which at table 10, includes: 2b: distance from staff member to medical device, 2d: closest by feet, second closest by feet, 3 a-g all pertaining to “workload attribute of a staff member,” and 5e: an alarm response time > goal (per time period); and based on this determination, an alert recipient sent the notification at 938; a backup may also be sent based on the priority). Dyell and Neubauer are analogous references as both deal with prioritizing alarms sent to caregivers based on the current environment of the medication situation and the caregiver’s capacity. One of ordinary skill in the art would have found these considerations as taught by Neubauer to be obvious to incorporate into the alarm prioritization of Dyell, as the reference teaches this solves the problem of: “Clinicians often find they are responding to conditions that do not require their skill level and could have been handled by a junior clinician. This results in a higher-than-necessary number of alarms being sent to the primary designated clinician. The sheer number of alarms received by such clinicians, particularly when the condition is not as serious as it appeared upon receipt of the alarm, exacerbates alarm fatigue.” (see 003). Neubauer teaches that these considerations allow for the alarm to be routed to the lowest level member who may handle the alarm itself, and to monitor the conditions surrounding the alarm and the type of issue, in order to provide more information to the recipient and therefore to improve the patient’s care. As such, considering staffing levels and response times as taught by Neubauer would have been obvious to include in the tiered alerts/warnings of Dyell.
In reference to claim 2:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein the controller is configured to: obtain, for each of the plurality of patients, a fourth information indicating a degree of loads needed for the caregiver to deal with the notification processing on per-hospital ward basis, if the notification processing is executed, and obtain the first information, indicating the degree of loads on the hospital ward, based on the fourth information corresponding to the plurality of patients (at least [fig 1 and related text, including 051-054] “Nurse Bob logs into an electronic chart at the patient's bedside and enters information about medications being provided to the patient into the electronic chart. Information entered by nurse Bob along with nurse Bob's credentials are sent to alarm management engine 12. Assume that Nurse Bob is set to end his shift at 9:00 AM after 8 hours of continuous work at the ICU. Alarm fatigue calculator 40 calculates nurse Bob's user fatigue at level V (e.g., highest level) at the time of last receipt of status data 27 based on user fatigue model 24 and user fatigue model attribute 26 determined from status data 27… Assume that medical device 16 substantially continuously measures the patient's blood pressure. A blood pressure reading at 8:16 AM indicates 130/90 mm Hg; at 8:20 AM indicates 120/80 mm Hg; and at 8:24 AM indicates 115/65 mmHg. Medical device model 28 corresponding to medical device 16 may specify that any blood pressure measurement over 120/80 mm Hg should generate an alarm. Patient condition 32 may specify that blood pressure for patients with a “serious” designation typically can vary beyond the normal range, but the rate of change is to be monitored more closely.” See also [031-032] for discussion of the intervals, i.e. continuous updating. The patient condition via vitals is updated on a continuous basis and used to change the alarm thresholds. ).
In reference to claim 3:
Dyell/Neubauer teaches all of the limitations above, with Dyell teaching obtaining information from a patient medical record (at least [062, 029] medical records indicate a patient has diagnosed hypertension). However, Dyell does not specifically disclose wherein the medical information is a fall risk. Neubauer further teaches wherein the controller is configured to obtain [patient information] based on at least one of a risk of falling of the patient, a disease state of the patient, and information on a room of the patient (at least [039] “The likelihood of an adverse event, such as the patient falling, may be evaluated using the Morse Falls Scale (MFS). Other examples of patient health assessments include a patient pain algorithm, a patient disease severity algorithm, a patient awareness algorithm, a patient agitation algorithm, a patient deterioration algorithm, and a mortality score such as the APACHE 2.” At [0185-187] “For example, physical capability, a psychometric aptitude to handing certain patients (e.g., delirious, dementia, etc.) are required to handling combative patients who are at an increased risk of falls and various bed exit alarms are alarming. “ See also table 10: numerous variables for a caregiver dealing with a person at a higher fall risk). Dyell and Neubauer are analogous references as both disclose a means of customizing communications based on patient information/conditions. One of ordinary skill in the art of caregiving would have found the inclusion of fall risk information obvious to include in any sort of medical information about a patient under their care, as falls can be extremely detrimental to the patient’s overall health. Neubauer also teaches through the reference, that a patient with a fall history would likely require more attention from caregiver(s) both for the physical conditions associated with a fall, and any other co-existing conditions (such as Alzheimer’s, dementia, etc. as identified above) that might make the a fall even more likely to occur. As such one of ordinary skill in the art would know fall risk information is particularly important in a caregiving situation.
In reference to claim 4:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: Wherein the controller is configured to: obtain the fourth information based on an electronic medical record of the patient (at least [062, 0029] medical records indicate history of hypertension),
update the fourth information if the electronic medical record of the patient is updated, and update the first information based on the updated fourth information (at least [028, 029] hypertension diagnosis may lead to expected high readings, i.e. a higher condition, at [053-054] patient’s blood pressure readings are stored, and may not generate an alert when they are slightly elevated, but a quick change in pressure would trigger the condition).
In reference to claim 5:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein in a case where a period is divided into a plurality of sub-periods, the controller is configured to update the first information at a timing when the time has passed from a first sub-period to a second sub-period (at least [031] “] During operation, alarm management engine 12 may receive status data 27 from user device 14. Status data 27 can be collected substantially continuously in some embodiments, and periodically (e.g., every 1, 5, 10, 15, 20, 30, 45 second and/or every 1, 5, 10, 15, 30, 45 minutes) in other embodiments. In some embodiments, status data 27 may be collected in predetermined time intervals or ranges (e.g., every 0-5 seconds, 5-10 seconds, 10-15 seconds, 15-20 seconds, 20-30 seconds, 30-45 seconds, 45-60 seconds and/or every 0-5, 5-10, 10-15, 15-30, or 30-45 minutes). Additionally, status data 27 may be collected on a “push” basis (e.g., in response to certain triggers such as alerts and responses to alerts) with user device 14 pushing status data 27 to alarm management engine 12. Alarm fatigue calculator 40 may calculate alarm fatigue levels associated with respective users of user device 14 based on one or more user fatigue model 24 in user fatigue model database 18.”)
In reference to claim 6:
Claim 6 is believed to be free of the prior art.
In reference to claim 7:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein in a case where the caregiver includes a plurality of caregivers, the controller is configured to update the second information at a timing when at least one of caregivers is coming to work or leaving work (at least [051-054] “At 8:00 AM, nurse Alice logs into user device 14 (e.g., computer) at a central hub in the ICU to begin her day's shift…Nurse Bob is set to end his shift at 9:00 AM after 8 hours of continuous work at the ICU.” – the second information is updated based on Bob’s fatigue levels as discussed in claim 1).
In reference to claim 8:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein in a case where the caregiver includes a plurality of caregivers, the controller is configured to update the second information at a timing when at least one of caregivers is coming to work or leaving work (at least [051-054] “At 8:00 AM, nurse Alice logs into user device 14 (e.g., computer) at a central hub in the ICU to begin her day's shift…Nurse Bob is set to end his shift at 9:00 AM after 8 hours of continuous work at the ICU.” – the second information is updated based on Bob’s fatigue levels as discussed in claim 1).
In reference to claim 9:
Dyell/Neubauer teaches all the limitations above. Dyell as cited teaches a controller, and determining a second information, but does not specifically disclose the second information including the time for a caregiver to deal with the notification processing. Neubauer however, does teach determin[ing] the second information based on a history of the first information and a history of time information indicating time needed for the caregiver to deal with the notification processing (at least [046-050, including table 3] “In certain embodiments of the present disclosure, an H1 sub-priority is assigned for an alarm associated with an infusion pump where all four of the following dynamic attributes are met: 1) the alarm stops the infusion, 2) the medication that is infusing is associated with a critical indication for use, 3) the medication affects a patient health measurement that is outside its normal range, and 4) the estimated time to perform a corrective action is greater than several minutes. A system error, e.g., a pump failure on an infusion pump that is infusing norepinephrine, meets these four criteria since the system error stops the infusion and Norepinephrine has a critical indication for use (it raises blood pressure for a patient with low pressure). Resolution of this example failure requires a lengthy corrective action that involves retrieving a new pump, connecting the pump to the patient, and reprogramming the infusion into the pump… An air-in-line alarm does not require a lengthy corrective action, however, and a nurse can resolve an air-in-line alarm by purging the line much quicker than getting a new pump, connecting the administration line, waiting for the replacement pump to start up, and reprogramming the pump. Addressing the air-in-line alarm in this way is routine and results in the patient being without a critical medication for less time, compared to the above example and warrants a lower sub-priority, e.g., H2.”). Dyell and Neubauer are analogous references as both disclose a means of interacting with a caregiver regarding a patient’s condition. One of ordinary skill in the art would have found the inclusion of “time to deal with” a given condition obvious to include in a conditional alert system, as Neubauer teaches that if lower priority alarms that may be resolved quickly are actually prioritized, this results in fewer higher priority alarms as many of these situations will naturally escalate (see 005). Further. “In certain embodiments, L1 alarms will escalate if clinicians do not respond to them. For example, a battery alarm with 30 minutes of life remaining that is initially assigned an L1 sub-priority will need to escalate if the device is not plugged into wall power within 15 minutes to allow time for escalation to a medium sub-priority and resolution by the escalation staff member. In another example, an L2 sub-priority escalates to a L1 sub-priority alarm after 30 minutes or does not escalate at all.” As plugging a device into a wall often takes almost no time, it would have been obvious to one of ordinary skill in the art to resolve these small tasks quickly rather than allowing them to turn into more serious issues, thereby improving patient care and provider productivity.
In reference to claim 10:
Dyell/Neubauer teaches all the limitations above. Dyell as cited teaches a controller, and determining a second information, but does not specifically disclose the second information including the time for a caregiver to deal with the notification processing. Neubauer however, does teach determin[ing] the second information based on a history of the first information and a history of time information indicating time needed for the caregiver to deal with the notification processing (at least [046-0450, including table 3] “In certain embodiments of the present disclosure, an H1 sub-priority is assigned for an alarm associated with an infusion pump where all four of the following dynamic attributes are met: 1) the alarm stops the infusion, 2) the medication that is infusing is associated with a critical indication for use, 3) the medication affects a patient health measurement that is outside its normal range, and 4) the estimated time to perform a corrective action is greater than several minutes. A system error, e.g., a pump failure on an infusion pump that is infusing norepinephrine, meets these four criteria since the system error stops the infusion and Norepinephrine has a critical indication for use (it raises blood pressure for a patient with low pressure). Resolution of this example failure requires a lengthy corrective action that involves retrieving a new pump, connecting the pump to the patient, and reprogramming the infusion into the pump…… An air-in-line alarm does not require a lengthy corrective action, however, and a nurse can resolve an air-in-line alarm by purging the line much quicker than getting a new pump, connecting the administration line, waiting for the replacement pump to start up, and reprogramming the pump. Addressing the air-in-line alarm in this way is routine and results in the patient being without a critical medication for less time, compared to the above example and warrants a lower sub-priority, e.g., H2.”).”) Dyell and Neubauer are analogous references as both disclose a means of interacting with a caregiver regarding a patient’s condition. One of ordinary skill in the art would have found the inclusion of “time to deal with” a given condition obvious to include in a conditional alert system, as Neubauer teaches that if lower priority alarms that may be resolved quickly are actually prioritized, this results in fewer higher priority alarms as many of these situations will naturally escalate (see 005). Further. “In certain embodiments, L1 alarms will escalate if clinicians do not respond to them. For example, a battery alarm with 30 minutes of life remaining that is initially assigned an L1 sub-priority will need to escalate if the device is not plugged into wall power within 15 minutes to allow time for escalation to a medium sub-priority and resolution by the escalation staff member. In another example, an L2 sub-priority escalates to a L1 sub-priority alarm after 30 minutes or does not escalate at all.” As plugging a device into a wall often takes almost no time, it would have been obvious to one of ordinary skill in the art to resolve these small tasks quickly rather than allowing them to turn into more serious issues, thereby improving patient care and provider productivity.
In reference to claim 11:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein the controller is configured to obtain the condition recommended for the patient based on at least one of the disease state of the patient, a moving range for the patient, moving means of the patient, and a movable range of a bed recommended for the patient (at least [029] “In another example, patient condition 32 can refer to a medical status of the patient (e.g., “undetermined” may correspond to a status of a patient awaiting physician and assessment; “good” may indicate that vital signs (e.g., pulse rate, oxygen levels, blood pressure, etc.) are stable and within normal limits, with the patient being conscious and comfortable; “fair” may indicate that vital signs are stable and within normal limits with the patient being conscious, but uncomfortable; “serious” may indicate that vital signs are unstable and not within normal limits, with the patient being acutely ill; “critical” may indicate that vital signs are unstable and not within normal limits with the patient being unconscious; “deceased” may indicate that the patient is dead). In another example, patient condition 32 of “hypertension” may indicate that the patient suffers from hypertension, with expected high blood pressure readings; patient condition 32 of “diabetes” may indicate that the patient suffers from diabetes with higher than normal blood sugar readings without medication, etc. In some embodiments, patient condition 32 may correspond to a mathematical model (e.g., polynomial function, alphanumeric value, matrix, etc.) of a corresponding physical or mental health condition.” At [053] “Medical device model 28 corresponding to medical device 16 may specify that any blood pressure measurement over 120/80 mm Hg should generate an alarm. Patient condition 32 may specify that blood pressure for patients with a “serious” designation typically can vary beyond the normal range, but the rate of change is to be monitored more closely.” – i.e. the state of the patient changes the conditions for notification).
In reference to claim 12:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein the display is configured to display the condition recommended for the patient in the setting screen (at least [fig 1 and related text including 052] manual data entry of the patient’s condition is manually entered into device 14).
In reference to claim 13:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein the display is configured to display an object indicating warning in the setting screen if the condition recommended for the patient and the condition set for the patient are different (at least [072] “Alarm management engine 12 may modify alarm condition O to alarm condition 1 for medical device C based on information from subscriptions database 58; and modify alarm condition O to alarm condition 2 for medical device E. Thus, alarm condition 1 may indicate that alarms are to be generated for users P and Q only when the patient's blood pressure crosses 130/90 mm Hg and the users are to be notified via vibratory mode to specific user devices; alarm condition 2 may indicate that alarms are to be generated for users P and Q only when the patient's blood pressure crosses 130/90 mm Hg and the alarms are to be audibly and visually activated at medical device E “ i.e. alarm conditions change based on the specific user’s being indicated into a different range of alert specifically that deviates from the original condition specified).
In reference to claim 14:
Dyell/Neubauer teaches all the limitations above. Dyell further teaches: wherein the controller is configured to determine a notification mode of the notification processing based on the fourth information (at least [032, 072, 077] “ , In various embodiments, adapter 46 modifies alarms 76 to modified alarm 78 according to alarm condition 44. Note that alarm condition 44 may be configured to increase a likelihood of the user (of medical device 16) responding to modified alarm 78 (e.g., relative to a likelihood of the user responding to alarms 76). Modification may comprise filtering alarms 76 to delete some of alarms 76 based on alarm condition 44 (e.g., alarm condition 44 may specific alarms once every 10 minutes so that any alarms generated in the intervening 9 minutes are discarded); modification may comprise altering a format of alarms 76 (e.g., changing a vibratory format to a visually blinking format; changing a text message alarm to a beeping sound alarm; changing alarm 76 comprising an alarm instruction to a vibration on the user's wearable device; etc.).”).
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20190295696, to Yang discloses individualizing patient ranges for various vital signs based on their condition(s) to minimize excess alarm(s).
Conclusion
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
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