DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted June 23, 2026. A Restriction Requirement was mailed September 10, 2025 with regard to claims 1 – 28, restricting the claims as follows: Group I (claims 1 – 16), Group II (claims 17 – 19), and Group III (claim 20). The Applicant elected Group I. Claims 1 – 2 are amended. Claims 21 – 42 were previously cancelled. Claim 43 is new. Claims 1 – 16 and 43 are pending examination.
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 .
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 – 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 1 – 16 are drawn to a device, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites displaying a measurement mode identifier list, a working mode definition area, and an area for defining workflow configuration information; wherein the measurement mode identifier list comprises multiple first measurement modes and multiple second measurement modes, the measurement mode identifier list is configured to receive an measurement mode selection instruction, the working mode definition area is configured to receive a working mode definition instruction, the area for defining the workflow configuration information is configured to receive an instruction for defining the workflow configuration information; and determining a working mode according to the working mode definition instruction, determining workflow configuration information in the working mode according to the instruction for defining the workflow configuration information; determine a first parameter according to first workflow configuration information: determine a second parameter according to second workflow configuration information; and select a target measurement mode, which corresponds to target workflow configuration information, from the measurement mode identifier list, according to the measurement mode selection instruction.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, relate to defining workflows based on vital signs measurements. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address a need for determining workflows that satisfy various measurement requirements (Step 2A Prong One: YES).
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “device”, “human-machine interaction apparatus”, “displaying the measurement mode identifier list comprises concurrently displaying multiple first measurement modes associated with a continuous measurement working mode and multiple second measurement modes associated with a discontinuous measurement working mode “,“processor”, “wherein the working mode comprises the continuous measurement working mode that includes the multiple first measurement modes and the discontinuous measurement working mode that includes the multiple second measurement modes”, “determine a monitoring page according to the workflow configuration information”, “receive and process a signal of the first parameter according to the first workflow configuration information to obtain a first parameter measurement result the workflow configuration includes first workflow configuration information in the continuous measurement working mode”, “receive and process a signal of the second parameter according to the second workflow configuration information to obtain a second parameter measurement result”, “the human-machine interaction apparatus is further configured to display a target monitoring page corresponding to the target measurement mode”
Claim 2: “device”, “processor”, “voice data. text data, image data, and device position”
Claim 3: “device”, “human-machine interaction apparatus”, “processor”
Claims 4 – 6, 9 – 10, 12, 14: “device”
Claim 7: “device”, “signal processing”
Claims 8, 13: “device”, “control element”
Claim 11: “device”, “locking control element”, “when switching between at least two monitoring pages, lock a parameter display area to a same position on each monitoring page for display, but not lock a parameter measurement result located inside the parameter display area”
Claim 15: “device”, “control element”, “when the close control element or the return control element is triggered, the area for defining the workflow configuration information is closed and the workflow configuration information is stored”
Claim 16: “device”, “the workflow configuration information further comprises a transmission manner for parameter measurement results”
Claim 43: “device”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0265] The monitor or module component can also include a main control circuit 1003, which needs to include at least one processor and at least one memory. Of course, the main control circuit 1003 can also include at least one of: a power source management module, power source IP module, and interface conversion circuit. The power management module is configured to control the power on/off of the entire machine, time sequence of power on/off for various power source domains on the board, and battery charging and discharging, etc. The power source IP module refers to associating the schematic diagram and PCB layout diagram of frequently revoked power circuit units into a separate power module, that is, converting an input voltage into an output voltage through a predetermined circuit, where the input voltage and output voltage are different, such as converting a voltage of 15V to 1.8\7, 3.3V, or 3.8V, etc. It can be understood that the power source IP module can be single-channel or multi-channel. When the power source IP module is single channel, the power source IP module can convert one input voltage into one output voltage. When the power source IP module is multi-channel, the power source IP module can convert one input voltage into multiple output voltages, and the voltage values of multiple output voltages can be the same or different, thus satisfying the different voltage requirements of multiple electronic components at the same time. Moreover, the module has fewer external interfaces and works as a black box in the system, and is decoupled from external hardware systems, improving the reliability of the entire power system. The interface conversion circuit is configured to convert the signals outputted by the smallest system module of the main control (i.e., at least one processor and at least one memory in the main control circuit 1003) into input standard signals required by actual external devices, such as converting RGB digital signals outputted by the main control CPU into VGA analog signals for supporting external VGA display function, or converting RMII signals into standard network differential signals for supporting external network function.
[0266] In addition, the monitor or module component can also include one or more of local display 1004, alarm circuit 1006, input interface circuit 1007, external communication and power source interface 1005. The main control circuit 1003 is configured to coordinate and control various boards, circuits, and devices in the monitor or module component. In this embodiment, the main control circuit 1003 is configured to control data exchange between the parameter measurement circuit 1002 and the communication interface circuit, as well as transmission of control signals, and to transmit physiological data to the display 1004 for display. It can also receive user control instructions from physical input interface circuits, such as touch screens or keyboards and buttons, and can also output control signals on how to acquire physiological parameters. The alarm circuit 1006 can be an audible and visual alarm circuit. The main control circuit 1003 completes the calculation of physiological parameters, and transmits the calculation results and waveforms of parameters to the host (such as the host, PC, central station, etc. with the display 1004) through the external communication and power source interface 1005. The external communication and power source interface 1005 can be one or a combination of local area network interfaces composed of Ethernet, Token Ring, Token Bus, and optical fiber distributed data interface (FDDI) as the backbone of these three networks, may also be one or a combination of wireless interfaces such as infrared, Bluetooth. WIFI, and WMTS communication, or may also be one or a combination of wired data connection interfaces such as RS232 and USB. The external communication and power source interface 1005 may also be one or a combination of a wireless data transmission interface and a wired data transmission interface. The host may be any computer device such as a host of a monitor, an electrocardiograph, an ultrasonic diagnosis instrument, a computer, etc., which is installed with compatible software to form a monitoring device. The host can also be a communication device, such as a mobile phone, monitor, or module component, which transmits data to a mobile phone that supports Bluetooth communication through a Bluetooth interface, achieving remote data transmission.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 16 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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.
Claim(s) 1 – 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Pierre (U.S. Publication Number 2016/0132957 A1) in view of Gibson et al., herein after Gibson (U.S. Patent Number 8,932,217 B2) further in view of Indorf et al., herein after Indorf (U.S. Publication Number 2018/0310822 A1).
Claim 1 (Currently Amended). St. Pierre teaches a vital sign monitoring device (paragraph 23 discloses vital signs measurement and/or monitoring devices), comprising:
a human-machine interaction apparatus, configured to display a measurement mode identifier list, a working mode definition area, and an area for defining workflow configuration information (paragraph 24 discloses the medical device includes a user interface, such as a touch screen (human-machine interaction device), and includes the ability to execute multiple workflows or profiles; paragraph 36 discloses the computing device may also have one or more input device(s) (e.g. a keyboard, a mouse, a pen, a sound or voice input device, a touch or swipe input device) and an output device(s) (e.g. a video display, speakers, a printer);
the working mode definition area is configured to receive a working mode definition instruction, the area for defining the workflow configuration information is configured to receive an instruction for defining the workflow configuration information (Figure 14; paragraph 45 discloses custom measurement units option for various monitored parameters such as blood pressure, temperature, and manual parameter units where the user may select the desired measurement units for the various parameters; claim 1); and
a processor (paragraph 34 discloses the computing device may include at least one processing unit and a system memory), configured to:
determine workflow configuration information in the working mode according to the instruction for defining the workflow configuration information (paragraph 45 discloses custom measurement units option for various monitored parameters such as blood pressure, temperature, and manual parameter units where the user may select the desired measurement units for the various parameters), and
determine a monitoring page according to the workflow configuration information (paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface), including:
when the working mode is the continuous measurement working mode (paragraph 25 discloses the medical device is configured to measure one or more physiological parameters of a health-care recipient, also referred to herein as a patient which can be configured to measure and/or monitor different parameters and such as temperature, SpO2, blood pressure (NIBP), respiratory rate:
determine a first parameter according to first workflow configuration information corresponding to the continuous measurement working mode (paragraph 25 discloses the medical device is configured to measure one or more physiological parameters of a health-care recipient, also referred to herein as a patient which can be configured to measure and/or monitor different parameters and such as temperature, SpO2, blood pressure (NIBP), respiratory rate and the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface; paragraph 45 discloses custom measurement units option for various monitored parameters such as blood pressure, temperature, and manual parameter units where the user may select the desired measurement units for the various parameters), and
receive and process a signal of the first parameter according to the first workflow configuration information to obtain a first parameter measurement result the workflow configuration includes first workflow configuration information in the continuous measurement working mode (paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface; paragraph 39 discloses the monitor device may be configured for use in a variety of applications in many varied locations and workflows, and since various clinical workflows are often different, providing a configurable device allows a single device to support many different workflows); and
select a target measurement mode, which corresponds to target workflow configuration information, from the measurement mode identifier list, according to the measurement mode selection instruction (paragraph 23 discloses a medical device that can be configured to measure and monitor a variety of patient parameters and can be connected to one or more sensors that enable monitoring of at least one physiological parameter associated with a patent where each sensor is physically attached to the patient to acquire measurements of a parameter associated with the sensor; paragraph 45 discloses custom measurement units option for various monitored parameters such as blood pressure, temperature, and manual parameter units where the user may select the desired measurement units for the various parameters);
wherein the human-machine interaction apparatus is further configured to display a target monitoring page corresponding to the target measurement mode (paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface).
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
determine a working mode according to the working mode definition instruction, wherein the working mode comprises the continuous measurement working mode that includes the multiple first measurement modes and the discontinuous measurement working mode that includes the multiple second measurement modes (column 16, lines 45 – 52 discloses the monitoring device is capable of continuously monitoring each of the physiologic parameters (NIBP, pulse rate, 3 and 5 lead ECG, respiration, SpO2) depending on the number and type of sensor assemblies that are connected; claim 1 discloses a plurality of physiological parameters are continuously monitored by said monitoring device), and the discontinuous measurement working mode comprises the multiple second measurement modes (column 30, lines 19 – 31 discloses the SpO2 control menu permits the setting of either continuous or a random (spot-check) SpO2 measurements, the setting of alarm limits and setting of the pulse tone, where the SpO2 can be periodically or randomly checked on the patient while simultaneously maintaining continuous monitoring of at least one other physiologic parameter).
when the working mode is the discontinuous measurement working mode:
determine a second parameter according to second workflow configuration information corresponding to the discontinuous measurement working mode (column 30, lines 19 – 31 discloses the SpO2 control menu permits the setting of either continuous or a random (spot-check) SpO2 measurements, the setting of alarm limits and setting of the pulse tone, where the SpO2 can be periodically or randomly checked on the patient while simultaneously maintaining continuous monitoring of at least one other physiologic parameter); and
receive and process a signal of the second parameter according to the second workflow configuration information to obtain a second parameter measurement result (column 39, lines 11 – 24 discloses the monitoring device, in addition to displaying current numerics and waveforms and the most recent measurements, it can also store a predetermined amount of patient data).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of St. Pierre to further include portable, battery powered, multi-parametric, vital signs monitoring device that can be used for both ambulatory and transport applications as well as bedside monitoring, which can also be worn by a patient as disclosed by Gibson.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of St. Pierre in this way to improve the level of alarm management with regard to existing physiologic monitoring devices and provide a multiple physiologic parameter monitoring device that can be more easily and effectively used by staff of varying skill levels (Gibson: column 2, lines 7 – 24 and column 3, lines 9 - 13).
St. Pierre and Gibson fail to explicitly teach the following limitations met by Indorf as cited:
wherein displaying the measurement mode identifier list comprises concurrently displaying multiple first measurement modes associated with a continuous measurement working mode and multiple second measurement modes associated with a discontinuous measurement working mode, the measurement mode identifier list is configured to receive an measurement mode selection instruction (Figure 10; paragraph 75 discloses the continuous version of the EWS (early warning system) calculation may be useful to give the clinician a moment by moment indication of changing health status of the patient. A spot check of the EWS may also be calculated periodically in an automatic fashion, where the EWS is calculated for instance every hour or every two hours or upon clinician request; paragraph 97 discloses the display is divided into two example sections: parameter selection (for selecting parameters to be contributors to EWS) and parameter ranges (for specifying ranges corresponding to contributor scores. Available parameters may also be defined by the hospital and may include parameters that are measured continuously using physiological sensors, parameters measured with spot checks using physiological sensors such as temperature or blood pressure, and/or parameters measured by observation of a clinician such as level of consciousness. The selected parameters in this example include SpO2, pulse rate, respiratory rate, temperature, and systolic blood pressure. With this selection made, a patient monitor can use each of these parameters to compute contributor scores and an EWS),
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of St. Pierre and Gibson to further include a portable spot-check system configured to assess the validity of a measured physiological parameter as disclosed by Indorf.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of St. Pierre and Gibson in this way by providing an early warning score which is a collection of vital signs and/or clinical observations representing the potential degree of patient deterioration, and facilitating a rapid response to the patient deterioration (Indorf: paragraph 50).
Claim 2 (Currently Amended). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 1. St. Pierre teaches a device wherein: the processor (paragraph 34 discloses the computing device may include at least one processing unit and a system memory) is further configured to determine environment information of the vital sign monitoring device, and to determine a monitoring situation according to the environment information, wherein the environment information comprises one or more of: voice data, text data, image data, and device position (paragraph 36 discloses a voice input device);
wherein in order to determine workflow configuration information in the working mode according to the instruction for defining the workflow configuration information, the processor (paragraph 34 discloses the computing device may include at least one processing unit and a system memory) is configured to: determine the workflow configuration information in the working mode and the monitoring situation, according to the instruction for defining the workflow configuration information (paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface).
Claim 3 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 1. St. Pierre discloses a device wherein: the human-machine interaction apparatus is further configured to display a monitoring situation definition area, wherein the monitoring situation definition area is configured to receive a monitoring situation definition instruction (paragraph 34 discloses the computing device may include at least one processing unit and a system memory; paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface); and
the processor is further configured to determine a monitoring situation according to the monitoring situation definition instruction (paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface; paragraph 34 discloses the computing device may include at least one processing unit and a system memory);
wherein in order to determine workflow configuration information in the working mode according to the instruction for defining the workflow configuration information, the processor is configured to: determine the workflow configuration information in the working mode and the monitoring situation, according to the instruction for defining the workflow configuration information (paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface; paragraph 34 discloses the computing device may include at least one processing unit and a system memory).
Claim 4 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 3. St. Pierre teaches wherein the monitoring situation definition area comprises a department type definition area configured to define a department type (Figure 4; paragraph 29 discloses the monitoring device is to be used in a hospital setting, office, or long term care location);
the monitoring situation comprises the department type (Figure 4; paragraph 29 discloses the monitoring device is to be used in a hospital setting, office, or long term care location);
the department type comprises at least one of General Ward, Emergency Department, Doctor Office, Long Term Care, Ambulatory Surgery Center, Community Health Service Center, and Neonatal Department (Figure 4; paragraph 29 discloses the monitoring device is to be used in a hospital setting, office, or long term care location).
Claim 5 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 4. St. Pierre discloses wherein the department type is classified according to a national region as follows:
when the national region is the United States, the department type comprises: General Ward, Emergency Department, Doctor Office, Long Term Care, and Ambulatory Surgery Center (Figure 4; paragraph 29 discloses the monitoring device is to be used in a hospital setting, office, or long term care location);
when the national region is Europe, the department type comprises: General Ward, Emergency Department, Doctor Office, and Ambulatory Surgery Center (Figure 4; paragraph 29 discloses the monitoring device is to be used in a hospital setting, office, or long term care location); and
when the national region is China, the department type comprises: General Ward, Emergency Department, Community Health Service Center, Ambulatory Surgery Center, and Neonatal Department (Figure 4; paragraph 29 discloses the monitoring device is to be used in a hospital setting, office, or long term care location).
St. Pierre and Gibson do not expressly show the regions cited (U.S., Europe, and China) claimed above. However these differences are only found in the nonfunctional descriptive material and are not functionally involved in the steps recited. The classification of the department type according to a national region can be performed the same regardless of the location. Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability, see In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 401 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to classification of the department type according to a national region because such data does not function relate to the steps in the method claimed and because subjection of interpretation of the data does not patentably distinguish the claimed invention.
Claim 6 (Previously Presented). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 2.
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
wherein the working mode definition area has at least one of following scenarios:
when the monitoring situation is the General Ward, the continuous measurement working mode comprises a continuous monitoring mode, wherein the discontinuous measurement working mode comprises a general round mode and an initial evaluation mode (column 4, lines 40 – 48 discloses a multiparametric monitoring device is provided that can be used in literally any patient setting, allowing the device to be used for monitoring a patient on hospital medical-surgical, telemetry and intermediate floors, hospital emergency departments, transport, emergency medical services and/or other healthcare applications where the monitoring device can be used for and/or between bedside, ambulatory, and transport);
when the monitoring situation is the Emergency Department, the continuous measurement working mode comprises a continuous monitoring mode, wherein the discontinuous measurement working mode comprises a triage mode and a spot check mode;
when the monitoring situation is the Doctor Office or the Community Health Service Center, the continuous measurement working mode comprises a continuous monitoring mode, wherein the discontinuous measurement working mode comprises a spot check mode;
when the monitoring situation is the Long Term Care, the continuous measurement working mode comprises a continuous monitoring mode, wherein the discontinuous measurement working mode comprises a general round mode and an initial evaluation mode;
when the monitoring situation is the Ambulatory Surgery Center, the continuous measurement working mode comprises a continuous monitoring mode, wherein the discontinuous measurement working mode comprises a recovery mode; and
when the monitoring situation is the Neonatal Department, the continuous measurement working mode comprises a continuous monitoring mode, wherein the discontinuous measurement working mode comprises a spot check mode.
The motivation to combine the teachings of St. Pierre, Gibson, and Indorf is discussed in the rejection of claim 1, and incorporated herein.
Claim 7 (Previously Presented). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 1. St. Pierre discloses wherein the area for defining the workflow configuration information comprises one or more of following setting areas: a workflow name setting area configured to receive a workflow name setting instruction;
a parameter layout setting area configured to set a parameter type or a parameter display layout rule, on the monitoring page (paragraph 23 discloses a medical device can be configured to measure and monitor a variety of patient parameters, where the medical device is functionally connected to one or more sensors that enable monitoring of at least one physiological parameter associated with a patent and each sensor is physically attached to the patient while the device is operating to acquire measurements of a parameter associated with the sensor; paragraph 25 discloses the user interface is configured to display representations of measurements of the physiological parameters of the patient and to receive commands, instructions, and/or inputs based on interaction of a clinician or user with the user interface); and
a parameter configuration setting area configured to set at least one of followings on the monitoring page: a parameter signal acquisition way, a parameter signal processing way and a parameter measurement result display way.
Claim 8 (Previously Presented). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 7.
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
wherein the monitoring page comprises at least two monitoring pages (Figure 19; column 23, lines 49 – 60 discloses the display modes can be toggled between large numeric display screens, waveform/numeric display screens, and trend data display screens);
the parameter layout setting area comprises at least two monitoring page layout setting areas configured to correspondingly define the at least two monitoring pages, wherein each monitoring page layout setting area is configured to set the parameter type or the parameter display layout rule on one corresponding monitoring page (Figure 64; column 34, lines 59 – 64 discloses upper and lower alarm limits for HR/PR can initially be set to alarm at an upper rate of 90 and a lower rate of 60. Using the latter feature, each time the SELECT button is actuated for the above feature in the control menu, the alarm limits can be incremented by a predetermined percentage (e.g., 5 percent, 10 percent, or other));
wherein each monitoring page layout setting area (column 23, lines 49 – 60 discloses numeric display screens, waveform/numeric display screens, and trend data display screens) comprises:
a parameter setting control element configured to set parameters on the corresponding monitoring page (column 34, lines 59 – 64 discloses upper and lower alarm limits for HR/PR can initially be set to alarm at an upper rate of 90 and a lower rate of 60. Using the latter feature, each time the SELECT button is actuated for the above feature in the control menu, the alarm limits can be incremented by a predetermined percentage (e.g., 5 percent, 10 percent, or other));
a control element for setting a parameter display order, configured to set a parameter display order for the parameters on the corresponding monitoring page (Figure 38 discloses a display screen of the monitoring device and in particular an Sp02 control menu); and
a control element for setting a parameter display area, configured to set a parameter display area for the parameters on the corresponding monitoring page, wherein the parameter display area displays a parameter measurement result (Figure 15; column 19, lines 55 – 61 discloses a current display screen displayed to the user during monitoring where the format includes a status panel, a large waveform panel and a parameter panel, respectively, as read from the top of the display screen).
The motivation to combine the teachings of St. Pierre, Gibson, and Indorf is discussed in the rejection of claim 1, and incorporated herein.
Claim 9 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 7.
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
wherein the parameters on the monitoring page comprise direct parameters directly measured by the vital sign monitoring device (column 34, lines 59 – 64 discloses upper and lower alarm limits for HR/PR can initially be set to alarm at an upper rate of 90 and a lower rate of 60. Using the latter feature, each time the SELECT button is actuated for the above feature in the control menu, the alarm limits can be incremented by a predetermined percentage (e.g., 5 percent, 10 percent, or other)), and manual parameters recorded through manual operation (column 3, lines 56 – 58 discloses the monitoring device is storing "snapshot" data and trended data to be manually or automatically transmitted).
The motivation to combine the teachings of St. Pierre, Gibson, and Indorf is discussed in the rejection of claim 1, and incorporated herein.
Claim 10 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 9. St. Pierre teaches a device wherein the manual parameters comprise customized parameters (Figure 14; paragraph 45 discloses custom measurement units option for various monitored parameters such as blood pressure, temperature, and manual parameter units where the user may select the desired measurement units for the various parameters; claim 1).
Claim 11 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 7.
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
wherein the parameter layout setting area comprises a locking control element configured to: when switching between at least two monitoring pages, lock a parameter display area to a same position on each monitoring page for display, but not lock a parameter measurement result located inside the parameter display area (Figure 59; column 35, lines 29 – 34 discloses the monitoring device provides a graphic display of a three or five lead ECG attachment with fixed locations being indicated).
The motivation to combine the teachings of St. Pierre, Gibson, and Indorf is discussed in the rejection of claim 1, and incorporated herein.
Claim 12 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 7.
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
wherein the parameter configuration setting area comprises one or more of following setting areas: an area for setting a parameter configuration item, configured to receive an instruction for setting a value of the parameter configuration item (column 30, lines 19 – 31 discloses the SpO2 control menu permits the setting of either continuous or a random (spot-check) SpO2 measurements, the setting of alarm limits and setting of the pulse tone, where the SpO2 can be periodically or randomly checked on the patient while simultaneously maintaining continuous monitoring of at least one other physiologic parameter);
an area for setting a monitoring mode, configured to receive an instruction for setting a parameter monitoring mode;
an area for setting alarm configuration, configured to receive an instruction for setting alarm configuration information; and
an area for setting a modular parameter monitoring tool, configured to receive an instruction for selecting the modular parameter monitoring tool.
The motivation to combine the teachings of St. Pierre, Gibson, and Indorf is discussed in the rejection of claim 1, and incorporated herein.
Claim 13 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 12.
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
wherein the area for setting the parameter configuration item comprises: a control element for setting a manual parameter configuration item, configured to set a customized parameter configuration item (column 30, lines 19 – 31 discloses the SpO2 control menu permits the setting of either continuous or a random (spot-check) SpO2 measurements, the setting of alarm limits and setting of the pulse tone, where the SpO2 can be periodically or randomly checked on the patient while simultaneously maintaining continuous monitoring of at least one other physiologic parameter).
The motivation to combine the teachings of St. Pierre, Gibson, and Indorf is discussed in the rejection of claim 1, and incorporated herein.
Claim 14 (Original). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 12. St. Pierre teaches wherein the area for setting the modular parameter monitoring tool comprises at least one of: an orthostatic hypotension evaluation tool, a multiple blood pressure measurement and recording tool, a blood pressure average measurement tool, and a cyanotic congenital heart disease monitoring tool (paragraph 25 discloses measuring and/or monitoring different parameters and such as temperature, SpO2, blood pressure (NIBP), and respiratory rate).
Claim 15 (Previously Presented). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 1.
St. Pierre fails to explicitly teach the following limitations met by Gibson as cited:
wherein the area for defining the workflow configuration information further comprises a close control element or a return control element (column 22, lines 25 – 40 discloses on the display of the monitoring device, the lower limit of the mean NIBP is currently disabled while the remaining alarm limits are each currently enabled, the alarm icons permit the user to access menus by which the alarms can be enabled or disabled, upper and lower limits can be set, and volume controls for audible tones can be adjusted);
when the close control element or the return control element is triggered, the area for defining the workflow configuration information is closed and the workflow configuration information is stored (column 4, lines 53 – 59 disclose the monitoring device can be custom configured to enable the device to be used in a specific facility, and can also be temporarily configured for a current patient, wherein settings can be selectively retained for the patient or deleted along with stored data upon power down of the device).
The motivation to combine the teachings of St. Pierre, Gibson, and Indorf is discussed in the rejection of claim 1, and incorporated herein.
Claim 16 (Previously Presented). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 1. St. Pierre discloses wherein the workflow configuration information further comprises a transmission manner for parameter measurement results (paragraph 36 discloses suitable communication connections include, but are not limited to, RF transmitter, receiver, and/or transceiver circuitry; universal serial bus (USB), parallel, and/or serial ports).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Pierre (U.S. Publication Number 2016/0132957 A1) in view of Gibson et al., herein after Gibson (U.S. Patent Number 8,932,217 B2) further in view of Indorf et al., herein after Indorf (U.S. Publication Number 2018/0310822 A1) and Zhu (U.S. Publication Number 2018/0113987 A1).
Claim 43 (New). St. Pierre, Gibson, and Indorf teach the vital sign monitoring device according to claim 1.
St. Pierre and Gibson fail to explicitly teach the following limitations met by Indorf as cited:
wherein the discontinuous measurement working mode comprises at least two of:
a general round mode for spot-checking vital sign parameters of multiple patients in sequence, and wherein the vital sign monitoring device is configured to transmit a vital sign parameter of a respective patient to a respective device (paragraph 62 discloses plurality of patient devices to receive information of a plurality of patients so that the nurse's station systems can provide clinicians with the ability to monitor physiological parameter data for a plurality of patients).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of St. Pierre and Gibson to further include a portable spot-check system configured to assess the validity of a measured physiological parameter as disclosed by Indorf.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of St. Pierre and Gibson in this way by providing an early warning score which is a collection of vital signs and/or clinical observations representing the potential degree of patient deterioration, and facilitating a rapid response to the patient deterioration (Indorf: paragraph 50).
St. Pierre, Gibson, and Indorf fail to explicitly teach the following limitations met by Zhu as cited:
an initial evaluation mode for a single measurement of a vital sign parameter for the respective patient, for obtaining an initial assessment of physical situation according to the measurement result, including an initial assessment for risk of falls (paragraph 90 discloses the wearable device is capable of monitoring both vital sign related information as well as health data, and the health data to be monitored by the wearable device include, but not limited to, diet, sleep, mood, activity level, environmental factors such as air/water quality, velocity of the body (to detect a fall), etc.); and
a triage mode for a single measurement of vital sign parameter for the respective patient to assess critical degree or level of the respective patient, so as to determine department to be visited by the respective patient.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of St. Pierre, Gibson, and Indorf to further include using wearable devices to quantitatively classify health conditions as disclosed by Zhu.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of St. Pierre, Gibson, and Indorf in this way by providing a wearable device is disclosed herein that is capable of continuously classifying a person's health condition into different classes based on trained models, by measuring/gathering various vital signs as well as health data of the person wearing the device. (Zhu: paragraph 73).
Response to Arguments
Applicant's arguments filed June 23, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections under 35 USC § 101
The Applicant argues the amended claims are patent-eligible under Step 2A Prong One because they are not directed to an abstract idea. The Examiner respectfully disagrees. The Examiner respectfully submits the present claims disclose displaying a measurement mode identifier list, a working mode definition area, and an area for defining workflow configuration information; wherein the measurement mode identifier list comprises multiple first measurement modes and multiple second measurement modes, the measurement mode identifier list is configured to receive an measurement mode selection instruction, the working mode definition area is configured to receive a working mode definition instruction, the area for defining the workflow configuration information is configured to receive an instruction for defining the workflow configuration information; and determining a working mode according to the working mode definition instruction, determining workflow configuration information in the working mode according to the instruction for defining the workflow configuration information; determine a first parameter according to first workflow configuration information: determine a second parameter according to second workflow configuration information; and select a target measurement mode, which corresponds to target workflow configuration information, from the measurement mode identifier list, according to the measurement mode selection instruction. The claim recites the additional limitations of a “device”, “human-machine interaction apparatus”, “displaying the measurement mode identifier list comprises concurrently displaying multiple first measurement modes associated with a continuous measurement working mode and multiple second measurement modes associated with a discontinuous measurement working mode”, “processor”, “wherein the working mode comprises the continuous measurement working mode that includes the multiple first measurement modes and the discontinuous measurement working mode that includes the multiple second measurement modes”, “determine a monitoring page according to the workflow configuration information”, “receive and process a signal of the first parameter according to the first workflow configuration information to obtain a first parameter measurement result the workflow configuration includes first workflow configuration information in the continuous measurement working mode”, “receive and process a signal of the second parameter according to the second workflow configuration information to obtain a second parameter measurement result”, “the human-machine interaction apparatus is further configured to display a target monitoring page corresponding to the target measurement mode”. Generic computer devices, as described by the applicant (see paragraph 266 of the published specification) recites the host can be a communication device, such as a mobile phone, monitor, or module component, which transmits data to a mobile phone that supports Bluetooth communication through a Bluetooth interface, achieving remote data transmission, which alone, do not amount to significantly more than the abstract idea. Viewing the limitations as an ordered combination does not add anything further than looking at the limitations individually. When viewed either individually, or as an ordered combination, the additional limitations do not amount to a claim as a whole that is significantly more than the abstract idea. Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea, thus, the claims are directed to an abstract idea. Therefore, Applicant’s argument is not persuasive and the rejection is maintained.
The Applicant argues the amended claims are patent-eligible under Step 2A Prong Two because they integrate any alleged abstract idea into a practical application. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
Claim Rejections under 35 USC § 103
Regarding claim 1, the Applicant argues features of the amended claim, specifically the “concurrent display of multiple first measurement modes associated with a continuous measurement working mode and multiple second measurement modes associated with a discontinuous measurement working mode”, which were not disclosed in the previous claims. New prior art has been cited with respect to the amendments submitted June 23, 2026, and is discussed in the rejection above.
Regarding claim 11, the Applicant argues Gibson fails to disclose the locking parameter. The Examiner respectfully submits Gibson discloses a lockout of the user interface and display, time limits on alarms and alerts, data trending, and the enablement of alarm and alert tones (column 13, lines 63 – 66), which indicates the lockout function. In addition, Gibson discloses the monitoring device provides a graphic display of a three or five lead ECG attachment with fixed locations being indicated (Figure 59; column 35, lines 29 – 34), indicating the display of multiple parameters. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
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.
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/K.K.R/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682
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