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 .
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 1-14 and 16-19 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
Claims 1 and 12 recite products and Claim 19 recites a process.
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)
Claims 12 and 19 recite the same abstract idea.
Step 2A, Prong 2
Claims 1, 12 and 19 do 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; 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. The transmitter also relates to the insignificant, post-solution activity of data reporting.
Claim 12 recites the additional elements of a medical device having a needle and a fluid line; receiver; a first transmitter; a computer; a temperature sensor; a heart rate sensor; a controller; a second transmitter; and a wearable device. The medical device with needle and fluid line and the wearable device are generically recited such that they only amount 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 computer, receiver, first transmitter, controller and second transmitter amount to generic computer implementation of the abstract idea with generic computer structure. The transmitters also relate to the insignificant, extra-solution activity of data reporting.
Claim 19 recites the additional elements of a medical device having a needle and a fluid line; receiver; a first transmitter; a computer; a temperature sensor; a heart rate sensor; a controller; a second transmitter; and a wearable device. The medical device with needle and fluid line and the wearable device are generically recited such that they only amount 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 computer, receiver, first transmitter, controller and second transmitter amount to generic computer implementation of the abstract idea with generic computer structure. The transmitters also relate to the insignificant, extra-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 amount to integration of the abstract idea into a practical application
Step 2B
Claims 1, 12 and 19 do 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; 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. The transmitter also relates to the insignificant, post-solution activity of data reporting.
Claim 12 recites the additional elements of a medical device having a needle and a fluid line; receiver; a first transmitter; a computer; a temperature sensor; a heart rate sensor; a controller; a second transmitter; and a wearable device. The medical device with needle and fluid line and the wearable device are generically recited such that they only amount 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 computer, receiver, first transmitter, controller and second transmitter amount to generic computer implementation of the abstract idea with generic computer structure. The transmitters also relate to the insignificant, extra-solution activity of data reporting.
Claim 19 recites the additional elements of a medical device having a needle and a fluid line; receiver; a first transmitter; a computer; a temperature sensor; a heart rate sensor; a controller; a second transmitter; and a wearable device. The medical device with needle and fluid line and the wearable device are generically recited such that they only amount 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 computer, receiver, first transmitter, controller and second transmitter amount to generic computer implementation of the abstract idea with generic computer structure. The transmitters also relate to the insignificant, extra-solution activity of data reporting.
Furthermore, the structural components of a wearable device, such as a medical device having a needle and a fluid line; a receiver; a first transmitter; a computer; a temperature sensor; a heart rate sensor; a controller; a second transmitter; and a wearable device are well-understood, routine and conventional structures in a hemodialysis system, as indicated by Banet et al. (2011/0066006). Banet discloses a wearable device 51 having temperature and heart rate sensors thereon; and a processor for receiving those signals so that the processor can use a “Composite Method” to determine pulse-transit time and ultimately blood pressure (par. [0010, 0041; Fig. 1) since, during dialysis, “rapid extraction of fluid can cause the patient’s blood pressure to quickly decrease due to the lack of volume in the vessels. This can also increase or reduce the patient's heart rate, increase their body temperature, and induce nausea and severe fatigue. In some cases these side effects can be life-threatening. Frequent hypotensive episodes, for example, have been linked to increased mortality in the dialysis population.” (par. [0006]). Therefore, these parameters are typically monitored during dialysis to make sure the patient is stable. The incorporation of transmitters receivers and controllers, as also disclosed by Banet (see Fig. 1; controller 22 and par. [0041, 0055, 0074] for various transmission devices) provides continuous feedback, monitoring and decision making. Lastly, the inclusion of a needle and fluid line is common practice in dialysis in which a needle with fluid line is connected to an arteriovenous fistula in the patient (par. [0047, 0055]).
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, 11, 16, 17 and 18 only generically link the abstract idea to another technological environment or field of use.
Claims 7 and 14 deal the insignificant extra-solution activity of generating an alert.
Claim 13 only further defines the abstract idea of deciding when the data exceeds a threshold value.
The Examiner notes Claims 15 and 20 include limitations that amount to a practical application in that the function of the device (transporting fluid) is altered in response to the alarm condition occurring. For Claim 15, the Examiner suggests indicating that a processor or other computing device within the system provides the configuration for stopping fluid flow.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 12, 13 and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Banet et al. (2011/0066006).
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 Claim 1, 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).”). 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.”)
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]).
Regarding Claims 12, 13 and 19, Banet discloses a hemodialysis device having a needle and fluid line (catheter) connectable to an arteriovenous fistula (par. [0047, 0055]). The hemodialysis machine has a transmitter, a receiver and processor for sending and receiving vital sign data as well as alert data from a monitoring device (abstract; par. [0011]). Banet further discloses 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).”). 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.”)
Regarding Claim 16, Banet discloses a monitoring device (e.g. central station) remote from the wearable device and the hemodialysis device, wherein the monitoring device is in wireless communication with the wearable device and hemodialysis device (par. [0019, 0021, 0041]).
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) 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) 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 reference 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 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 reference 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(s) 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) 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 reference 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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) in view of Steinberg (PGPUB 2023/0081378), further in view of Elbadry et al. (2019/0358387). Banet and Steinberg disclose all of the claimed invention except for including calibration circuitry in the charging station. However, Elbadry discloses incorporating calibration circuitry into a charging station (par. [0106]) for the purpose of predictably ensuring proper operation of the device each time it is used. 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 Steinberg combination to include calibration circuitry in the charging station, as taught and suggested by Elbadry, for the purpose of predictably ensuring proper operation of the device each time it is used.
Claim(s) 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (2011/0066006) in view of Olde et al. (U.S. Patent 11,123,010). Banet discloses generating alert signals in response to deteriorating vital signs such as blood pressure and heart rate but fails to disclose stopping fluid flow along the fluid line when the alarm/alert is indicated. However, Olde discloses stopping fluid flow in the hemodialysis device once vitals drop below a threshold (such as blood pressure) for the purpose of reducing the effects of hypotension or avoiding hypotension events during dialysis (col. 3, lines 28-43). 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 stopping fluid flow after an alert condition, as taught and suggested by Olde, for the purpose of reducing the effects of hypotension or avoiding hypotension events during dialysis.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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