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 .
Response to Arguments
Applicant's amendments and arguments filed 2/20/2026 with respect to the 35 USC 101 rejections have been fully considered but they are not persuasive. The setting of the data acquisition rate only amounts to the insignificant, extra-solution activity of data gathering. See the amended rejection.
Applicant’s amendment filed 2/20/2026, with respect to the 35 USC 102 and 103 rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Banet et al. (2011/0066006) in view of Brown et al. (2016/0038074).
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 1-11, 21 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process abstract idea without significantly more.
Step 1
Claim 1 recites a product.
Step 2A, Prong 1
Claim 1 recites the steps of “generating an alarm signal when a threshold value is reached based upon a temperature value measured by the at least one temperature sensor and a heart rate value measured by the at least one heart rate sensor”. These steps are broadly claimed that they amount to a clinician looking at a set of temperature and heart rate data and mentally determining an out of threshold (abnormal condition) and indicating such verbally or with pen and paper (noting that an alert condition has occurred)
Step 2A, Prong 2
Claim 1 does not include any additional elements that integrate the abstract idea into a practical application.
Claim 1 recites the additional elements of a wearable device; a temperature sensor; a heart rate sensor; a controller; setting data acquisition rates with the controller; and a transmitter. The wearable device is generically recited such that it only amounts to generically linking the abstract idea to another technological environment or field of use. The temperature sensor and heart rate sensor are generically claimed and only amount to the insignificant, extra-solution activity of data gathering. The controller and transmitter amount to generic computer implementation of the abstract idea with generic computer structure. Setting the data acquisition rate only amounts to the insignificant, extra-solution activity of data gathering. The transmitter also relates to the insignificant, post-solution activity of data reporting.
Step 2B
Claim 1 does not include any additional elements that, alone or in combination, amount to significantly more than the abstract idea itself.
Claim 1 recites the additional elements of a wearable device; a temperature sensor; a heart rate sensor; a controller; setting data acquisition rates with the controller and a transmitter. The wearable device is generically recited such that it only amounts to generically linking the abstract idea to another technological environment or field of use. The temperature sensor and heart rate sensor are generically claimed and only amount to the insignificant, extra-solution activity of data gathering. The controller and transmitter amount to generic computer implementation of the abstract idea with generic computer structure. Setting the data acquisition rate only amounts to the insignificant, extra-solution activity of data gathering. The transmitter also relates to the insignificant, post-solution activity of data reporting.
Generically linking the abstract idea to another technological environment or field of use; generic computer implementation of the abstract idea and insignificant, extra-solution activity do not, alone or in combination, amount to significantly more than the abstract idea itself. Additionally, adding well-understood, routine and conventional features in the art also does not amount to significantly more than the abstract idea itself.
Claims 2, 3, 5, 6, 8, 9 and 10 only further define the insignificant, extra-solution activity of data gathering.
Claims 4 and 11 only generically link the abstract idea to another technological environment or field of use.
Claims 7 and 21 deal with the insignificant extra-solution activity of generating an alert.
Claim 22 introduces an abstract idea of a method of organizing human activity (providing instructions to stop treatment). Alternatively, the “instructions…to stop treatment” amounts to data reporting and/or a form of an alarm. This is not an active step of actually disabling or stopping treatment, just an alert to indicate it needs to be stopped.
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 1-6 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) in view of Brown et al. (2016/0038074).
The Examiner notes the term “a venous needle monitoring device” in the preamble of Claim 1 is an intended use recitation. The body of the claim does not positively recite a venous needle and therefore “…the preamble is not considered a limitation and is of no significance to claim construction”, see MPEP §2111.02, II.
Regarding Claims 1 and 21, Banet discloses a device comprising a wearable device 51 (and its connected components 82, 74, 96, 72, etc., basically every worn component in Fig. 10A); at least one temperature sensor arranged on the wearable device to sense temperature of a user; at least one heart rate sensor arranged on the wearable device to sense heart rate of the user (Fig. 1; par. [0041]); a controller (e.g. a microprocessor) carried on the wearable device (par. [0041], “A microprocessor in the body-worn monitor 51 receives these waveforms and then processes them according to the Composite Method, described in detail below, to continuously determine the patient's blood pressure and other vital signs.”), the controller in communication with the at least one temperature and at least one heart rate sensor, wherein the controller is configured to generate an alarm signal when a threshold value is reached based upon temperature and heart rate values obtained by the temperature and heart rate sensor, respectively (par. [0055], “Once this is done, the medical professional initiates continuous monitoring of vital signs (e.g. blood pressure, ECG/heart rate, SpO2, temperature, respiratory rate) for the patient (step 63) using the body-worn monitor. The monitor on each patient then wirelessly transmits information to the central monitoring station (step 64) so that the patient is continuously monitored. When a patient's vital signs exceed a predetermined threshold (step 65), an alarm is generated and sent wirelessly to central monitoring station (step 66).”). When the alarm is generated, a remedial action can be performed such as changing parameters of treatment (par. [0055]). Lastly, Banet discloses a transmitter, carried on the wearable device, the transmitter configured to transmit the alarm signal to one or more medical devices treating the user (par. [0041], “A microprocessor in the body-worn monitor 51 receives these waveforms and then processes them according to the Composite Method, described in detail below, to continuously determine the patient's blood pressure and other vital signs. This information transfers through a cable 31 to a controller 22 within the hemodialysis machine 55 and sent wirelessly to a receiver in central monitoring station. Alternatively, the cable 31 can be replaced by a wireless interface, such as a Bluetooth (802.15.4) or WiFi (802.11) interface. In this case, the body-worn monitor 51 includes the controller, and all measurements are made on the patient's body and sent wirelessly to the hemodialysis machine 55.”). Banet is silent regarding a power management scheme in which a sensor data acquisition frequency is reduced when therapy is not being applied by the system.
However, Brown, concerned with the common problem of power optimization in wearable monitoring devices discloses determining whether or not a treatment is being performed (by monitoring bit 15, see Table 2; par. [0129]); and entering a low power mode when therapy is not applied, wherein the low power mode has a data rate that is below a data rate in a normal or high power mode (bit 11:10, see Table 2; par. [0128-0129]) for the purpose of reducing power consumption of the sensors when treatment is not active (par. [0128]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Banet reference to include entering a low power mode in which a data acquisition rate is less than in anormal operating mode, as taught and suggested by Brown, for the purpose of reducing power consumption of the sensors when treatment is not active.
Regarding claims 2 and 3, Banet discloses measuring heart rate variability from the heart rate sensor to detect abnormal conditions (par. [0073]).
In regard to Claim 4, Banet discloses electrodes on a face of the wearable device (the metallic portions of electrode 78a adapted to touch the skin) that are used to determine heart rate (par. [0041]). These electrodes also include a thermocouple for measuring temperature (par. [0045]).
With regard to Claim 5, Banet also discloses including a blood oxygen sensor coupled to the controller (par. [0017, 0045]).
In regard to Claim 6, Banet discloses the pulse oxygen sensor detects reflected light (par. [0051]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) in view of Brown et al. (2016/0038074), further in view of Tran et al. (U.S. Patent 10,998,101). Banet discloses providing alerts/alarms (par. [0021, 0055]) but does not indicate any particular form of delivery of the alert/alarm. However, in the same field of endeavor of vital sign monitoring, Tran discloses providing alerts/feedback in the form of audio, visual or haptic feedback (col. 7, lines 9-13), which predictably provides the result of meaningful alert information to the user in response to the measurement assessments of the gather vital sign data. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Banet and Brown combination to include haptic, audio or visual feedback, as taught and suggested by Tran, for the purpose of providing meaningful alert information to the user in response to the measurement assessments of the gather vital sign data.
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) in view of Brown et al. (2016/0038074), further in view of Rovatti et al. (PGPUB 2022/0249025). Banet discloses obtaining heart rate measurements but fails to disclose obtaining heart rate measurements from optical sensors and instead obtains them from ECG signals. However, in the same field of endeavor of monitoring during hemodialysis procedures, Rovatti discloses utilizing an optical sensor 100 (instead of a separate device such as an ECG sensor) having an LED emitter and a photodetector 57 disposed adjacent to the LED (par. [0122]; Fig. 3) for the purpose of reducing user discomfort (par. [0007] and increased reliability by reducing extra components in the system (par. [0008]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Banet and Brown combination to include using the optical sensors as a heart rate sensor instead of ECG sensors, as taught and suggested by Rovatti, for the purpose of reducing user discomfort (par. [0007] and increased reliability by reducing extra components in the system.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) in view of Brown et al. (2016/0038074), further in view of Steinberg (PGPUB 2023/0081378). Banet discloses utilizing rechargeable batteries inside the arm/wrist-worn monitoring device but fails to disclose the particular means in which the batteries are recharged. However, Steinberg discloses either mounting a docket station between the device and the arm while in use or mounting the device to a docking station when not in use for the purpose of inductively charging the battery of the device, thus increasing portability/mobility without having to directly connect to a power source with a cable and to allow the device to work without constantly having to change out batteries (par. [0010]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Banet and Brown combination to include a docking station with inductive coupling/charging capabilities, as taught and suggested by Steinberg, for the purpose of inductively charging the battery of the device, thus increasing portability/mobility without having to directly connect to a power source with a cable and to allow the device to work without constantly having to change out batteries.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) in view of Brown et al. (2016/0038074), further in view of Parisotto et al. (2016/0199562). Banet discloses monitoring various parameters, such as blood pressure, of a patient during hemodialysis and issuing an alarm if the measured parameters are not within the threshold range. Banet is silent regarding stopping the hemodialysis entirely when an alarm is issued. However, in the same field of endeavor of hemodialysis machines, Parisotto discloses stopping the operation of the hemodialysis device when a blood pressure threshold is exceeded and an alarm is issued for the purpose of minimizing potential blood loss to the patient due to a venous needle dislodgment (par. [0124]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Banet and Brown combination to include stopping the hemodialysis machine in response to an alarm, as taught and suggested by Parisotto, for the purpose of minimizing potential blood loss to the patient due to a venous needle dislodgment.
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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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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