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 .
Status of Claims
This action is in reply to the present action filed on 06/16/2026.
Claims 1, 5-7, and 19 have been amended.
Claims 21-22 have been added.
Claims 1-14 and 19-22 are currently pending and have been examined.
This action is made FINAL.
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.
Claims 1-12 are rejected under 35 USC 103 as being unpatentable over Volpe et al. (US 20170258401 A1) in view of Kwak et al. (WO 2019177207 A1), Palmroos et al. (US 20090157432 A1), and Receveur et al. (US 20210065885 A1).
Regarding Claim 1, Volpe discloses the following:
An adaptive healthcare system comprising: (Volpe discloses aspects and examples are directed to apparatus and processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location [0033].)
…[device] including a user interface with a plurality of settings for controlling operation of at least one medical device, (Volpe discloses FIG. 4 shows a schematic of an example of the controller 120 of FIGS. 1, 2A, 2B and 3. The controller 120 includes at least one processor 418, … a user interface 408, …[0045]. The user interface 408 includes one or more physical interface devices such as input devices, output devices, and combination input/output devices and a software stack configured to drive operation of the devices. These user interface elements may render visual, audio, and/or tactile content, including content relating to location-specific processing [0048]. FIGS. 2A and 2B illustrate an example of the controller 120…The display 220 can be implemented as a touch screen interactive user interface. Accordingly, the patient and/or a caregiver can interact with the display 220 to control the medical device 100.)
the user interface having a power saving mode and a power unrestricted mode; (Volpe discloses the at least one processor may be further configured to operate the network interface in a power conservation mode when not to determining whether the ambulatory medical device is within the predefined range of the reference location [0017]. The Examiner interprets the device as being in power unrestricted mode when it is not in “power conservation mode”.)
a monitoring system including: a device location identifier; (Volpe discloses the processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate location-specific processing in response to determining that the ambulatory medical device is within the predefined range,…[0010]. FIG. 5 illustrates one of these processes, a proximity monitoring process 500. As shown, the proximity monitoring process 500 is executed by a proximity monitoring component …of a controller…of a medical device [0065].)
a processor and memory, the memory containing instructions that when carried out by the processor, cause the processor to: (Volpe discloses the ambulatory medical device includes at least one sensor configured to acquire data descriptive of a patient; a memory; a user interface; and at least one processor coupled with the memory, the at least one sensor, and the user interface [0010].)
detect that a proximity between the device location identifier and one of the plurality of caregiver location identifiers is within a predetermined range; (Volpe discloses processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location [0033]. In yet some examples, the reference location may be based on a mobile device such as a patient, caregiver or other predetermined person's smartphone or tablet [0051].)
switch the user interface from the power saving mode to the power unrestricted mode; (Volpe discloses processor may be further configured to operate the network interface in a power conservation mode when not to determining whether the ambulatory medical device is within the predefined range of the reference location [0017].)
The difference between the primary reference and the claimed subject matter is that Volpe does not disclose the interface being switched between power modes as a result of the detected proximity between the person and the device. It would have been obvious to one of ordinary skill in the art at the time of the invention to have incorporated switching the device into full power mode when the device is detected to be near to the caregiver into the system of Volpe. This modification would enable the preservation of a device’s battery when it is determined it is not in use service as there are a finite number of identified, predictable potential solutions to the need of battery conservation of a medical device. One of ordinary skill in the art could have pursued such power saving mode with a reasonable expectation of success.
Volpe does not disclose providing access to the device based on the caregiver classification which is met by Kwak:
and a plurality of caregiver location identifiers that include at least one of a first caregiver classification and a second caregiver classification; (Kwak teaches the authority controller 343 may check the access authority granted to the user based on the confirmed role (that is, the grade). When the access right is confirmed for the authenticated user, a medical service corresponding to a request (e.g., a request for access/control to the medical IoT device) received from the user terminal may be provided (p. 15, ¶ 0004). In operation 530, the authentication controller 342 may authenticate a user based on identifier information of the user terminal (p. 14, ¶ 0007). The Examiner interprets the caregiver's role as their classification.)
determine if the detected caregiver location identifier includes the first caregiver classification or the second caregiver classification; (Kwak teaches the authority controller may determine whether a role corresponding to the user is a patient, a nurse, a doctor, or a security manager, and check the access authority specified according to a predefined policy with respect to the identified role (p. 4, ¶ 0002).)
and enable at least one of the plurality of settings of the medical device based on a combination of the proximity and the determined caregiver classification of the detected caregiver location identifier. (Kwak teaches authority by level, can be defined as follows. For example, a nurse (grade 1) may issue only commands (GET, POST, etc.) to specific medical IoT devices such as temperature sensors (thermometers), blood pressure sensors, glucose sensors, insulin pumps, and the like. Only authorized devices can have access. And the doctor (grade 2) may have more access rights than the nurse (p. 10, ¶ 0004).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate providing access to the medical device based on the caregiver’s classification as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Volpe and Kwak do not teach the user interface switching power modes which is met by Palmroos:
the user interface having a power saving mode and a power unrestricted mode; (Palmroos teaches the power saving dimming feature may be turned on or off depending on such factors as…the CCA in which the medical device currently resides, the CCA for which the medical device is being prepared for use, or the personal preference of the clinician. For example, where it is critical to the caregiver or the patient that the clinician not be distracted by having to return a display screen to an appropriate brightness by touching the screen, the power saving default power saving mode when on A/C 620 may be turned off …where dimming of the backlight is not as critical or is not critical, the Default power saving mode when on A/C may be selected at 620, as illustrated in FIG. 6 so that all medical devices within that CCA will dim after a preselected time [0063]. The Examiner interprets the screen as a user interface (see Fig. 5).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the user interface switching power modes as taught by Palmroos. This modification would conserve power and to prevent undue wear and tear on the hardware of the device (see Palmroos, ¶ 0006).
Volpe, Kwak, and Palmroos do not teach the device being a patient table or detectable tags carried by caregivers which is met by Receveur:
a patient table… (Receveur teaches this disclosure is applicable to other types of patient support apparatuses, including other types of beds, surgical tables, examination tables,…[0125].)
wherein the plurality of caregiver location identifiers are detectable tags carried by the caregivers; (Receveur teaches the transceivers 104 or receivers 104…receive wireless transmissions from caregiver locating tags 102 that are worn by respective caregivers 114 and from equipment tags 102 that are attached to various pieces of equipment such as patient beds 110. Thus, when tag 102 is worn or carried by a caregiver, it is considered to be a caregiver locating tag 102 …[0128].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the device being a patient table or detectable tags carried by caregivers as taught by Receveur. This modification would create a system which provides a high accuracy in caregiver tracking and therefore can improve caregivers’ workflows (see Receveur, ¶ 0004).
Regarding Claim 2, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 1 above. Volpe does not disclose the following limitations met by Kwak:
the processor is further caused to enable a first plurality of settings for the first caregiver classification and a second plurality of settings that includes all the first plurality of settings and additional settings for the second caregiver classification. (Kwak teaches the user level may be divided according to the role…the nurses, doctors, and senior doctors may be classified into Level 1, Level 2, and Level 3, and the policy indicating access rights for Class 1, access rights for Class 2, and access rights for Class 3 (policy)… authority by level, can be defined as follows. For example, a nurse (grade 1) may issue only commands (GET, POST, etc.) to specific medical IoT devices such as temperature sensors (thermometers), blood pressure sensors, glucose sensors, insulin pumps,… Only authorized devices can have access. And the doctor (grade 2) may have more access rights than the nurse (p. 10, ¶ 0004). The Examiner interprets the nurse as being the first caregiver and the doctor as the second caregiver with greater access.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the second caregiver having greater access than the first as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Regarding Claim 3, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 2 above. Volpe does not disclose the following limitations met by Kwak:
the at least one of the first and second caregiver classifications includes a plurality of additional caregiver classifications with access to different pluralities of settings than the first and second plurality of settings. (Kwak teaches the user terminal is an electronic device possessed by a user such as a patient, a doctor, a senior doctor, a pharmacist, a nurse, and may include a tablet, a PC, a smartphone, and the like (p. 6, ¶ 0002). The Examiner interprets the senior doctor as an additional caregiver classification which would have greater access than a nurse or doctor.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate an additional caregiver classification providing differing levels of access than the first and second caregiver settings as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Regarding Claim 4, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 3 above. Volpe does not disclose the following limitations met by Kwak:
wherein the second caregiver classification is associated with an individual with greater responsibilities to a patient than the first caregiver classification, (Kwak teaches the nurses, doctors, and senior doctors may be classified into Level 1, Level 2, and Level 3, and the policy indicating access rights for Class 1, access rights for Class 2, and access rights for Class 3 (policy) ) May be set differently. Rule, that is, authority by level, can be defined as follows. For example, a nurse (grade 1) may issue only commands (GET, POST, etc.) to specific medical IoT devices such as temperature sensors… glucose sensors,…Only authorized devices can have access. And the doctor (grade 2) may have more access rights than the nurse (p. 10, ¶ 0004). The Examiner interprets the nurse as being the first caregiver and the doctor as the second caregiver with greater responsibility.)
and the plurality of additional caregiver classifications includes a third caregiver classification that is associated with an individual with greater responsibilities to the patient than the second caregiver classification. (Kwak teaches the user terminal is an electronic device possessed by a user such as a patient, a doctor, a senior doctor, a pharmacist, a nurse, and may include a tablet, a PC, a smartphone… (p. 6, ¶ 0002). The Examiner interprets the senior doctor as an additional caregiver classification which would have greater responsibility than a nurse or doctor.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the second caregiver having greater access than the first and the additional caregiver having more access than both as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Regarding Claim 5, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 1 above. Volpe further discloses:
the device location identifier is coupled to the at least one medical device and the at least one medical device is in operable communication with the [device] (Volpe discloses the processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate location-specific processing in response to determining that the ambulatory medical device is within the predefined range,…[0010]. The reference location may refer to at least one of a fixed geographic location, a location of a fixed device,…[0011]. FIG. 5 illustrates one of these processes, a proximity monitoring process 500. As shown, the proximity monitoring process 500 is executed by a proximity monitoring component …of a controller…of a medical device [0065].)
Volpe, Kwak, and Palmroos do not teach the device being a table which is met by Receveur:
…the patient table. (Receveur teaches this disclosure is applicable to other types of patient support apparatuses, including other types of beds, surgical tables, examination tables,…[0125].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the device being a patient table as taught by Receveur. This modification would create a system which provides a high accuracy in caregiver tracking and therefore can improve caregivers’ workflows (see Receveur, ¶ 0004).
Regarding Claim 6, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 1 above. Volpe, Kwak, and Receveur do not teach the following limitations met by Palmroos:
the user interface includes a display that is one of off or dimmed in the power saving mode and illuminated in the power unrestricted mode. (Palmroos teaches to conserve power and wear and tear on the display hardware, some prior art devices have an automatic dimming feature that dims the display to a preset brightness level after a period set in the medical device. To restore the brightness level, the clinician must touch the display [0063]. The Examiner interprets the screen dimming as being the power saving mode of the device.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the interface including a display which is dimmed in power saving mode as taught by Palmroos. This modification would create a system which prevents undue wear and tear on the display hardware (see Palmroos, ¶ 0006).
Regarding Claim 7, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 6 above. Volpe does not disclose the following limitation met by Kwak:
upon determining that the caregiver classification is a high enough classification (Kwak teaches the authority controller may determine whether a role corresponding to the user is a patient, a nurse, a doctor, or a security manager, and check the access authority specified according to a predefined policy with respect to the identified role (p. 4, ¶ 0002). For example, if the user of the user terminal 330 is a nurse, a predetermined policy corresponding to a nurse may be extracted, and if a user is a doctor, a predetermined policy corresponding to a doctor may be extracted. The authorization controller 343 extracts a permission corresponding to the user terminal 330 from a permission DB, and extracts a context corresponding to the user terminal 330 from a context constraint DB (p. 17, ¶ 0002).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate determining caregiver classification is high enough as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Volpe and Kwak do not teach the following limitations met by Palmroos:
wherein the plurality of settings are displayed on the user interface in the power unrestricted mode. (Palmroos teaches Fig. 6 and 7 which show the interface displayed to the user including buttons for modifying the settings of the medical device infusion parameters such as volumetric rate and VTBI. When a default brightness level has been selected for a particular medical device, the medical device will maintain that default brightness level unless or until it is adjusted by a user/clinician at the device or is automatically dimmed [0058]. The Examiner interprets the default brightness level of the screen as power unrestricted mode, the dimmed screen as power saving mode, and the ‘view delivery screen’ as displaying settings.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the interface including a display which is dimmed in power saving mode as taught by Palmroos. This modification would create a system which prevents undue wear and tear on the display hardware (see Palmroos, ¶ 0006).
Regarding Claim 8, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 1 above. Volpe and Kwak do not teach the following limitations met by Palmroos:
wherein the at least one medical device includes a medical device with a delivery rate critical to the support of the patient. (Palmroos teaches FIG. 5 illustrates a multi-channel infusion pump 14 with a split touch screen 122 having a first channel screen portion 140 associated with first channel 132 and a second channel screen portion 142 associated with the second channel 136. Each channel screen portion 140 and 142 presents a subset of the delivery information regarding the respective channels 132 or 136, including without limitation therapeutic agent name, concentration, dose rate, VTBI, and alarm information…[0046].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the medical device having a delivery rate critical to supporting the patient as taught by Palmroos. This modification would create a system which improves patient safety and therapy (see Palmroos, ¶ 0004).
Regarding Claim 9, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 8 above. Volpe and Kwak do not teach the following limitations met by Palmroos:
wherein the plurality of settings includes monitoring the delivery rate and adjusting the delivery rate. (Palmroos teaches each channel screen portion 140 and 142 presents a subset of the delivery information regarding the respective channels 132 or 136, including…therapeutic agent name, concentration, dose rate,… [0046]. By using the Channel Level Therapy Buttons 145 and the Program Level Buttons 147, the healthcare practitioner can program each individual channel of the pump with specific fluid therapies…other delivery specifications for the following modes: Basic Therapy --includes dose calculation, which allows does rate programming …, drug amount, infusion time and drug concentration and simple rate programming that allows programming of volumetric rate (mL/hr)…[0052]. See Fig. 5-6 which show options for editing the settings of delivery rate.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the medical device settings including monitoring and adjusting the delivery rate as taught by Palmroos. This modification would create a system which improves patient safety and therapy (see Palmroos, ¶ 0004).
Regarding Claim 10, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 8 above. Volpe does not disclose the following limitations met by Kwak:
wherein the first caregiver classification enables the monitoring …but restricts adjusting… (Kwak teaches Permission may represent a permission for a particular mode of work in connection with one or more medical services. Based on access rights, rights holders can perform some tasks on the system. For example, a nurse may be authorized to retrieve thermometer (i.e., medical IoT device) readings,… (p. 11, ¶ 0005). The Examiner interprets the nurse only being authorized to retrieve readings as an authorization for monitoring and no authorization for adjusting.)
and the second caregiver classification enables the monitoring…and adjustment… (Kwak teaches Bob (Class 2) may have all the rights of Alice (Class 1) and additionally issue commands and access to sensitive medical IoT devices such as EEG, ECG, vision sensors, hearing sensors, etc. (p. 10, ¶ 0004).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the second caregiver having greater access than the first and the first caregiver only having access to monitoring as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Volpe and Kwak do not teach the medical device having a delivery rate which is met by Palmroos:
…of the delivery rate… (Palmroos teaches FIG. 5 illustrates a multi-channel infusion pump 14 with a split touch screen…and a second channel screen portion 142 associated with the second channel 136. Each channel screen portion 140 and 142 presents a subset of the delivery information regarding the respective channels 132 or 136, including without limitation therapeutic agent name, concentration, dose rate,… [0046].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the medical device having a delivery rate for supporting the patient as taught by Palmroos. This modification would create a system which improves patient safety and therapy (see Palmroos, ¶ 0004).
Regarding Claim 11, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 1 above. Volpe does not disclose the following limitations met by Kwak:
…and upon determining if the detected caregiver location identifier includes the first caregiver classification or the second caregiver classification, (Kwak teaches the authority controller 343 may check the access authority granted to the user based on the confirmed role (that is, the grade). When the access right is confirmed for the authenticated user, a medical service corresponding to a request (e.g., a request for access / control to the medical IoT device) received from the user terminal may be provided (p. 15, ¶ 0004). The Examiner interprets the caregiver's role as their classification.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate providing access to the medical device based on the caregiver’s classification as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Volpe and Kwak do not teach the following limitations met by Palmroos:
wherein the memory includes a power management protocol that causes the processor to: reduce power to a non-critical feature of the at least one medical devices; (Palmroos teaches FIG. 6 further illustrates that at graphical user interface 600 a user may configure the backlight using a default power saving mode when on A/C power 620 setting. To conserve power and wear and tear on the display hardware, some prior art devices have an automatic dimming feature that dims the display to a preset brightness level…[0063]. The Examiner interprets the level of brightness of the screen as the non-critical feature which is being reduced in power.)
unrestricting the power to the non-critical feature associated with the at least one of the plurality of settings that are enabled. (Palmroos teaches to conserve power and wear and tear on the display hardware, some prior art devices have an automatic dimming feature that dims the display to a preset brightness level after a period set in the medical device. To restore the brightness level, the clinician must touch the display [0063]. The Examiner interprets the display brightness level increasing to normal levels as unrestricting the power level.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the interface including a display which is dimmed in power saving mode as taught by Palmroos. This modification would create a system which prevents undue wear and tear on the display hardware (see Palmroos, ¶ 0006).
Regarding Claim 12, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 11 above. Volpe and Kwak do not teach the following limitations met by Palmroos:
wherein the at least one medical device includes a drug delivery system and the non-critical feature includes a visualization of a delivery rate of a medication on the user interface. (Palmroos teaches each channel screen portion 140 and 142 presents a subset of the delivery information regarding the respective channels 132 or 136, including …concentration, dose rate,…[0046]. By using the Channel Level Therapy Buttons 145 and the Program Level Buttons 147, the healthcare practitioner can program each individual channel of the pump with specific fluid therapies…other delivery specifications for the following modes: Basic Therapy--includes dose calculation, which allows does rate programming …, drug amount, infusion time and drug concentration and simple rate programming that allows programming of volumetric rate (mL/hr)…[0052]. Fig. 5 and 6 show the display screen of the delivery rate of the drug which provides visualization for the user.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate the medical device being a drug delivery system as taught by Palmroos. This modification would create a system which prevents undue wear and tear on the display hardware (see Palmroos, ¶ 0006).
Claim 13 is rejected under 35 USC 103 as being unpatentable over Volpe, Kwak, Palmroos, and Receveur in view of Sevadjian et al. (US 20100205741 A1).
Regarding Claim 13, Volpe, Kwak, Palmroos, and Receveur teach the limitations as seen in the rejection of Claim 11. Volpe, Kwak, Palmroos, and Receveur do not teach the following limitations met by Sevadjian:
wherein the non-critical feature includes at least one of a weight sensor or an adjustment mechanism in a patient table. (Sevadjian teaches a therapeutic table with one or more position adjustment mechanisms and an activation means comprising one or more ribbon switches, whereby the activation of said particular position adjustment mechanism is achieved by applying pressure on said corresponding ribbon switches [0013].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate a non-critical feature being an adjustment mechanisms in a patient table as taught by Sevadjian. This modification would create a system which allows for adjustment of the table that is unobtrusive, accessible from any position around the table, and easy to use (see Sevadjian, ¶ 0010).
Claim 14 is rejected under 35 USC 103 as being unpatentable over Volpe, Kwak, Palmroos, and Receveur in view of Bera et al. (US 20230360780 A1).
Regarding Claim 14, Volpe, Kwak, Palmroos, and Receveur teach the limitation as seen in the rejection of Claim 1 above. Volpe does not disclose the following limitations met by Kwak:
…the caregiver classification of the detected caregiver,…and if the caregiver classification of the detected caregiver is authorized to the access the plurality of settings. (Kwak teaches the authority controller 343 may check the access authority granted to the user based on the confirmed role (that is, the grade). When the access right is confirmed for the authenticated user, a medical service corresponding to a request (e.g., a request for access / control to the medical IoT device) received from the user terminal may be provided (p. 15, ¶ 0004). The Examiner interprets the caregiver's role as their classification.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate providing access to the medical device based on the caregiver’s classification as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Volpe, Kwak, Palmroos, and Receveur do not teach the following limitations met by Bera:
wherein the processor is further caused to log any interactions between the detected caregiver location and the at least one medical device that includes attempted access to the plurality of settings,… (Bera teaches an interaction may refer to, for example, a record of which menu(s) were accessed by the caregiver, which settings were used, how long the caregiver interacted with a certain function of the medical equipment, which function(s) were used, how the equipment was used on client, where on the client a part of the equipment was positioned, how fast it was moved, for how long was it used, etc. [0083].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate logging interactions between the caregiver and the device as taught by Bera. This modification would create a system which improves availability and access to information which can be relevant to a caregiver (see Bera, ¶ 0033).
Claims 19 and 21 are rejected under 35 USC 103 as being unpatentable over Volpe et al. (US 20170258401 A1) in view of Kwak et al. (WO 2019177207 A1) and Mukherjee et al. (US 20190320899 A1).
Regarding Claim 19, Volpe discloses the following limitations:
An adaptive healthcare system comprising: a medical device including a plurality of settings; (Volpe discloses aspects and examples are directed to apparatus and processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location [0033].)
a monitoring system including: a device location identifier; (Volpe discloses the processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate location-specific processing in response to determining that the ambulatory medical device is within the predefined range,…[0010]. FIG. 5 illustrates one of these processes, a proximity monitoring process 500. As shown, the proximity monitoring process 500 is executed by a proximity monitoring component …of a controller…of a medical device [0065].)
a processor and memory, the memory containing instructions that when carried out by the processor, cause the processor to: (Volpe discloses the ambulatory medical device includes at least one sensor configured to acquire data descriptive of a patient; a memory; a user interface; and at least one processor coupled with the memory, the at least one sensor, and the user interface [0010].)
detect that a proximity between the device location identifier and the personnel location identifier associated with the caregiver classification is within a predetermined range; (Volpe discloses processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location [0033]. In yet some examples, the reference location may be based on a mobile device such as a …caregiver… [0051].)
enable a restricted plurality of settings…a combination of the proximity and… (Volpe discloses processes in accord with the proximity detection process 600 enable a medical device to determine whether the medical device is within a predefined range (e.g., 100 feet) to a reference location, thereby enabling the medical device to execute (or not execute) subsequent processes that are relevant to the reference location and predefined range [0077].)
detect if a proximity between the device location identifier and the personnel location identifier…is within a predetermined range; (Volpe discloses processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location [0033]. In yet some examples, the reference location may be based on a mobile device such as a patient, caregiver or other predetermined person's smartphone or tablet [0051].)
…and if the personnel location identifier associated with the oversight classification is not within the predetermined range,… (Volpe discloses in act 606, the proximity monitoring component determines whether the calculated distance is within a predefined range of distance values…If the proximity monitoring component determines that the calculated distance is not within the predefined range, the proximity monitoring component executes act 610…. In the act 610, the proximity monitoring component stores an indication that the controller is not within the predefined range of the current reference location [0075-76].)
Volpe does not disclose providing access to the device based on the caregiver classification which is met by Kwak:
and a pair of personnel…identifiers that include a caregiver classification and an oversight classification; (Kwak teaches the user terminal is an electronic device possessed by a user such as a patient, a doctor, a senior doctor, a pharmacist, a nurse, and may include a tablet, a PC, a smartphone, and the like (p. 6, ¶ 0002). The Examiner interprets the senior doctor as a caregiver with an oversight classification which would have greater access than a nurse or doctor which have caregiver classifications.)
enable a restricted plurality of settings of the medical device based on…the caregiver classification; (Kwak teaches a registration control unit for registering in association with the provided identifier information of the corresponding user, an authentication control unit for authenticating the user based on the identifier information of the user terminal, and confirming the role of the corresponding user for the authenticated user, and confirming the identified role And a rights control unit for checking an access right granted to the corresponding user based on the above, and the medical service corresponding to the request received from the user terminal based on the identified access right may be provided to the logged in user (p. 3, ¶ 0007).)
…personnel…associated with the oversight classification… (Kwak teaches the nurses, doctors, and senior doctors may be classified into Level 1, Level 2, and Level 3, and the policy indicating access rights for Class 1, access rights for Class 2, and access rights for Class 3 (policy) ) May be set differently (p. 10, ¶ 0004). The Examiner interprets the senior doctor as having the oversight classification.)
if the personnel…identifier associated with the oversight classification …enable additional plurality of settings of the medical device; (Kwak teaches Alice, Bob, and Charlie are registered in the health prescription assistant and security system 340 as roles of nurses, doctors, and senior physicians, respectively. … Accordingly, the nurses, doctors, and senior doctors may be classified into Level 1, Level 2, and Level 3, and the policy indicating access rights for Class 1, access rights for Class 2, and access rights for Class 3 (policy)) May be set differently. … For example, a nurse (grade 1) may issue only commands …to specific medical IoT devices such as temperature sensors …And the doctor (grade 2) may have more access rights than the nurse…You may have Charlie (Class 3) has all the rights that Bob (Class 2) has, but can have access to implanted IoT devices, such as an IoT-enabled pacemaker that is implanted in the body. In addition, Charlie (grade 3) may have the authority to prescribe medicines in emergency or fatal situations by issuing orders in smart medicine boxes, such as Pill Bottles (p. 10, ¶ 0004). The Examiner interprets the senior doctor as the personnel identifier which has an oversight classification and more settings enabled.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate providing access to the medical device based on the caregiver’s classification and oversight classification as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Volpe and Kwak do not teach preventing access to settings if the personnel is not within the range which is met by Mukherjee:
if the personnel …is not within the predetermined range, prevent access to the additional plurality of settings of the medical device. (Mukherjee teaches at block 440, access of the user device 115-d may be revoked. For example, access of the user device 115-d may be revoked in part on the proximity between the user device 115-d and the identification tag associated with the central monitoring station 135-b exceeding a threshold distance represented by proximity 420-a. Thus if a user of user device 115-d walks away from the central monitoring station 135-b (e.g., exceeds a threshold distance), access of the user device 115-d may be revoked, resulting in the physiological information failing to be displayed at the central monitoring station 135-b [0075].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate preventing access to settings if the personnel is not within the range as taught by Mukherjee. This modification would create a system which filters patient data based on credentials of the clinician (see Mukherjee, ¶ 0003).
Regarding Claim 21, this claim recites limitations that are substantially similar to those recited in Claim 19 above; thus, the same rejection applies. Volpe does not disclose the following limitations met by Kwak:
…a pair of personnel…identifiers that include a first personnel … identifier associated with a first classification of a first caregiver and a second personnel… identifier associated with a second classification of a second caregiver; (Kwak teaches the user terminal is an electronic device possessed by a user such as a patient, a doctor, a senior doctor, a pharmacist, a nurse, and may include a tablet, a PC, a smartphone, and the like (p. 6, ¶ 0002). The Examiner interprets the nurse as a first personnel with a first classification and a doctor or senior doctor as a second personnel with a second classification.)
Volpe and Kwak do not teach detecting a second member which is met by Kwak:
detect the location of a second caregiver using the second…location identifier, (Mukherjee teaches the identification tag may be user-specific and therefore may reflect a current user or occupant of central monitoring station 135-a. Thus multiple users (e.g., clinicians) may use or occupy central monitoring station 135-a, and the identification tag may be updated accordingly.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate detecting the proximity of a second member as taught by Mukherjee. This modification would create a system which allows a variety clinicians to monitor patients (see Mukherjee, ¶ 0003).
Claim 20 is rejected under 35 USC 103 as being unpatentable over Volpe, Kwak, and Mukherjee in view of Bera et al. (US 20230360780 A1).
Regarding Claim 20, Volpe, Kwak, and Mukherjee teach the limitation as seen in the rejection of Claim 19 above. Volpe, Kwak, and Mukherjee do not teach the following limitations met by Bera:
wherein the processor is further caused to log any interactions between the detected personal location and the medical device. (Bera teaches an interaction may refer to, for example, a record of which menu(s) were accessed by the caregiver, which settings were used, how long the caregiver interacted with a certain function of the medical equipment, which function(s) were used, how the equipment was used on client, where on the client a part of the equipment was positioned, how fast it was moved, for how long was it used, etc. [0083].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate logging interactions between the caregiver and the device as taught by Bera. This modification would create a system which improves availability and access to information which can be relevant to a caregiver (see Bera, ¶ 0033).
Claim 22 is rejected under 35 USC 103 as being unpatentable over Volpe, Kwak, and Mukherjee in view of Xu et al. (JP 2014516493 A).
Regarding Claim 22, Volpe, Kwak, and Mukherjee teach the limitations as seen in the rejection of Claim 21 above. Volpe further discloses:
the processor is further caused to:…based on the location of the…caregiver being within the predetermined range,… (Volpe discloses processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location [0033]. In yet some examples, the reference location may be based on a mobile device such as a patient, caregiver or other predetermined person's smartphone or tablet [0051].)
Volpe does not disclose enabling additional settings based which is met by Kwak:
after the additional settings of the medical device have been enabled (Kwak teaches the nurses, doctors, and senior doctors may be classified into Level 1, Level 2, and Level 3, and the policy indicating access rights for Class 1, access rights for Class 2, and access rights for Class 3 (policy)) May be set differently. … For example, a nurse (grade 1) may issue only commands …to specific medical IoT devices such as temperature sensors …And the doctor (grade 2) may have more access rights than the nurse…You may have Charlie (Class 3) has all the rights that Bob (Class 2) has, but can have access to implanted IoT devices, such as an IoT-enabled pacemaker that is implanted in the body. In addition, Charlie (grade 3) may have the authority to prescribe medicines in emergency or fatal situations by issuing orders in smart medicine boxes, such as Pill Bottles (p. 10, ¶ 0004). The Examiner interprets the senior doctor as the personnel identifier which has an oversight classification and more settings enabled.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate providing additional settings to certain caregivers as taught by Kwak. This modification would create a system which prevents a situation in which the user's life is at risk due to the invasion of the privacy of the patient's medical records and unauthorized access to medical devices (see Kwak, p. 4, ¶ 0009).
Volpe and Kwak do not teach detecting a second caregiver location which is met by Mukherjee:
…based on the location of the second caregiver… (Mukherjee teaches the identification tag may be user-specific and therefore may reflect a current user or occupant of central monitoring station 135-a. Thus multiple users (e.g., clinicians) may use or occupy central monitoring station 135-a, and the identification tag may be updated accordingly.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate detecting the proximity of a second member as taught by Mukherjee. This modification would create a system which allows a variety clinicians to monitor patients (see Mukherjee, ¶ 0003).
Volpe, Kwak, and Mukherjee do not teach expanding the range which is met by Xu:
…expand the predetermined range to a larger area (Xu teaches detecting detection data that is almost out of the normal range or slightly out of the normal range increases the detection frequency of that sensor and other possible related sensors (p. 26, ¶ 0004).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for detecting the proximity between a medical device and a caregiver and switching the device’s power mode as disclosed by Volpe to incorporate expanding the sensing range as taught by Xu. This modification would create a system which can increase a sensor’s sensitivity and specificity for objects (see Xu, p. 28, ¶ 0012).
Relevant Prior Art Made of Record Not Currently Being Applied
The following references are considered pertinent to the Applicant’s disclosure but are not currently being applied:
Azizan et al. (US 20210158955 A1) teaches a system in which a user device detects a beacon associated with a medical system, and if the devices does not detect the beacon, the user is provided with a second set of medical features.
Response to Arguments
Regarding rejections under 35 USC 103 to Claims 1-14 and 19-22, Applicant’s arguments have been considered and are persuasive. Therefore, the rejection has been withdrawn. However, a new rejection has been made, rejecting Claim 1 over Volpe in view of , Kwak, Palmroos, and Receveur.
Applicant argues Claim 1 currently recites switching a user interface to a power unrestricted mode upon the detection of a caregiver. The OA is relying on Volpe as teaching this. However, Volpe only relates to power conservation of a "network interface" that facilitates communication across a network and the power conservation is only when "proximity monitoring component is not actively executing a proximity monitoring process" per paragraph [0052] (see Applicant’s Remarks, p. 9)
Regarding (a), Examiner respectfully disagrees. In the office action mailed 03/16/2026, the user interface was a part of the medical device. Therefore, under broadest reasonable interpretation, if the medical device was in a low power mode, then the user interface would be in a low power mode as well. However, the amendments modify the claims such that the user interface is connected to a patient table and the user interface controls a medical device, so the user interface is no longer a part of the medical device. In light of this amendment, the rejection has been updated, rejecting claim 1 over Volpe in view of Kwak, Palmroos, and Receveur.
Applicant argues claim 1 has been amended and now recites, in part, "a patient table including a user interface with a plurality of settings for controlling operation of at least one medical device, the user interface having a power saving mode and a power unrestricted mode," and "a plurality of caregiver location identifiers that include at least one of a first caregiver classification and a second caregiver classification, wherein the plurality of caregiver location identifiers are detectable tags carried by the caregivers." The references as cited fail to teach, suggest, or otherwise disclose every element of amended claim 1 (p. 10).
Regarding (b), Examiner agrees the amended limitations are not entirely met by Volpe and Kwak, and therefore the rejection has been updated in light of such amendments, rejecting claim 1 over Volpe in view of Kwak, Palmroos, and Receveur.
Applicant argues as it further relates to claim 6, it recites that the user interface includes a display that is one of off or dimmed in the power saving mode and illuminated in the power unrestricted mode. Palmroos, on the other hand, generally discloses a device where undimming is based on direct interaction with a touch display, i.e., not proximity of a caregiver (p. 12).
Regarding (c), Examiner respectfully disagrees. Volpe teaches the switching of into a low power mode based on proximity and Palmroos is only used to teach the interface dimming as a result of low power mode.
Applicant argues as it relates to claim 7, it has been amended and now recites, in part, "the plurality of settings are displayed on the user interface in the power unrestricted mode upon determining that the caregiver classification of the detected caregiver location identifier is a high enough classification." For similar reasons provided in support of claim 6, the prior art of record does not teach, suggest, or otherwise disclose these features. As such, claim 7 is allowable for at least this additional reason. (p. 12).
Regarding (d), Examiner respectfully disagrees. There are no explanation as to how the references do not teach the limitations of claim 7. Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them.
Applicant argues as it relates to independent claim 19, it has been amended and now recites, in part, "if the personnel location identifier associated with the oversight classification is not within the predetermined range, prevent access to the additional plurality of settings of the medical device." The OA concedes that Volpe is silent as to teaching or suggesting any type of oversight classification and relies on Kwak and Bera. However, in Kwak, the identifier is generally associated with an authentication step at a terminal and not directly based on proximity. Bera on the other hand, is silent as to oversight classifications, much less based on predetermined ranges (p. 13).
Regarding (e), Examiner respectfully disagrees. In light of the amendments, Claim 19 has been updated to reject the claim over Volpe in view of Kwak and Mukherjee which teaches the prevention of access if a personnel member is not within the range.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA R GEDRA whose telephone number is (571)270-0944. The examiner can normally be reached Monday - Friday 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA R. GEDRA/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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