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 .
Election/Restrictions
Applicant's election with traverse of claims 1-36 in the reply filed on August 28, 2024 is acknowledged. The traversal is on the ground(s) that all currently pending claims would not pose an undue burden on the Examiner. This is not found persuasive because the claims are different inventions. It is undue for the examiner to search more than one invention that are divergent inventions since the system of Group I requires Bluetooth low energy SOC, and the method of pregnancy monitoring of Group II could be performed by a materially different system.
The requirement is still deemed proper and is therefore made FINAL.
Claims 37-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/28/2024.
Claims 1-36 are pending and under examination.
Claim Objections
Claims 8, 18 and 36 are objected to because of the following informalities:
Claim 8 recites “simultaneously detection” in lines 3-4 but should read “simultaneous detection”.
Claim 18 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
Claim 36 recites “fetal hear rate” in the last line but should read “fetal heart rate”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 15-28 and 33-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 33 contain(s) the trademark/trade name BLUETOOTH®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, it is unclear if Applicant is claiming a generic Bluetooth, short-range wireless enabled chip or relying on a specific Bluetooth branded chip structure, accordingly, the identification/description is indefinite.
2-34 and 35-36 are rejected due to their dependence on an indefinite claim.
Claim 15 recites “configured to detect photoplethysmogram (PPG) and/or a peripheral temperature” making it only a requirement for PPG. Subsequently, claim 16 recites “the third sensor system comprises a pulse oximetry and a thermometer for detecting the peripheral temperature” which requires both. It is unclear if the temperature detection and hence the thermometer is optional or required, therefore claims are indefinite.
Claims 17-28 are rejected due to their dependence on indefinite claims 15 and 16.
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 1-28 and 33-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) a sensor network to process physiological parameters.
Regarding claim 1, the limitations of “receiving, from the plurality of sensor systems, to process, the physiological parameters” is a process, as drafted, the covers performance of the limitation that can be performed by a human under the broadest reasonable interpretation. For example, receiving sensor data regarding physiological sensors encompasses nothing more than a user viewing physiological readouts from a sensor. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in a human mind, then it falls within the “Mental Process” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
This judicial exception is not integrated into a practical application because. In particular, the claim recites the additional elements of “a sensor member configured to detect data associated with at least one of physiological parameters of the subject,” “a Bluetooth low energy system-on-a-chip (BLE SoC) configured to process and transmit the detected data” and “a controller adapted in wireless communication with the plurality of sensor systems to display the physiological parameters”. Sensors are recited at a high-level of generality (i.e., any sensor able to detect physiological activity) and amount to no more than mere pre-solution activity of data gathering. Displaying amounts to nothing more than post-solution activity of displaying the sensed physiological parameters. The processor (i.e. “processor” or “computer processor”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining set parameters and calculate steps) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to the integration of the abstract idea into a practical application, the additional element of using sensors to detect physiological parameters amounts to no more than pre-solution activity of data gathering and displaying received physiological parameters from sensors amounts to nothing more than post-solution activity of displaying, which are no more than mere instructions to apply the exception which cannot provide an inventive concept. The claim is not patent eligible.
Regarding claims 2-28 and 33-36, these limitations further limit the details of the sensors or sensor systems of claim 1. These limitations amount to no more than mere pre-solution activity of data gathering as set forth above for claim 1.
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) 1-5, 8, 10-13, 15-20, 29 and 31-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1, , cited by Applicant) in view of Hayes-Gill et al. (US 2016/0058363 A1, hereinafter “Hayes-Gill”, cited by Applicant).
Regarding claim 1, Embert discloses a sensor network for pregnancy monitoring of a subject, comprising:
a plurality of sensor systems time-synchronized to each other (par. [0009], [00035]: System 100 includes a number of optional independent sensors/probes designed to monitor various aspects of maternal and/or fetal health, [00079]-[00080]: … synchronous pulse signal using, for example, fetal heartbeat data and/or a fetal blood pressure data), wherein each sensor system is placed on a respective region of the subject and comprises a sensor member configured to detect data associated with at least one of physiological parameters of the subject (par. [00035]: …probes/sensors are a NIRS adult hemoglobin probe 125, a pulse oximetry probe 130, a Doppler and/or ultrasound probe 135, a uterine contraction measurement device 140, and an electrocardiography (ECG) device 170).
While Embert discloses a Bluetooth configured to process and transmit (Fig. 1 and pars. [00025]: …wireless communication of one or more components of system 100 may be enabled using short-range wireless communication protocols designed to communicate over relatively short distances (e.g., BLUETOOTH®…)…with…a computer or personal electronic device (e.g., tablet computer or smart phone, par. [0038]: Communication of receiver 145 with other components of system may be made using wired or wireless communication) ; and
a controller to receive, from the plurality of sensor systems, to process, and to display the physiological parameters (par. [00038] Measurements and/or signals from NIRS adult hemoglobin probe 125, pulse oximetry probe 130, Doppler and/or ultrasound probe 135, and/or uterine contraction measurement device 140 may be communicated to receiver 145 for communication to computer 150 and display on display device 155…).
Embert does not expressly disclose Bluetooth low energy system-on-a-chip (BLE SoC) configured to process and transmit the detected data.
However, Hayes-Gill in the same field of endeavor: fetal movement monitor, discloses a Bluetooth low energy system-on-a-chip (BLE SoC) (Fig. par. [0093]: … local receiving device is provided in the form of a portable communications device 34, which may comprise a mobile phone, smartphone, PDA, tablet, laptop or similar communication device having receiver/transmitter circuitry, a user interface and one or more processors, [0094]: …monitoring device on the mother's abdomen transmits the processed data via a radio signal (e.g. Wi-Fi, Bluetooth?, Bluetooth Low Energy or suitable standard, such as a mobile telephony standard) to the device 34) configured to process and transmit the detected data (pars. [0040]: …the processor device of the apparatus being arranged to transmit…[0092]: The transmitter 28 can then transmit the output data via a…wireless data connection with a receiving device using conventional data transmission means and/or standards) for the purpose of providing equipment offering more reliable and/or convenient monitoring of fetal activity in a home environment (par. [0011]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with multiple sensors of Embert, a controller that uses BLE SoC wireless communication to transmit and display sensor data, as taught by Hayes-Gill in order to identifying a user's activity (par. [0005]).
Regarding claim 2, the Embert and Hayes-Gill combination discloses the sensor network of claim 1, wherein the plurality of sensor systems comprises a first sensor system (Embert, Fig. 1 (135)), a second sensor system (Embert, Fig. 1 (170)) and a third sensor system (Embert, Fig. 1 (130)) respectively placed on an abdominal region, a chest region and a limb region of the subject (Embert, par. [00035]: ECG device 170 may be used to determine the pregnant mammal’s…heart rate…The Doppler and/or ultrasound probe 135 may be configured to be placed on the abdomen of the pregnant mammal … Pulse oximetry probe 130 may be a conventional pulse oximetry probe placed on pregnant mammal's hand and/or finger to measure the pregnant mammal’s hemoglobin oxygen saturation).
Regarding claim 3, the Embert and Hayes-Gill combination discloses the sensor network of claim 2, wherein the second sensor system is configured to be a central node, while the first and third sensor systems are configured to be peripheral nodes (Embert, Fig. 1 (130) (135) (170) and par. [00038]: …signals from…pulse oximetry probe 130, Doppler and/or ultrasound probe 135, …may be communicated to receiver 145 for communication to computer 150 and display on display device 155 and, in some instances, may be considered secondary signals; according to Fig. 1 the second sensor ECG sensor 170 can be arranged as the central node while Doppler sensor 135 and pulse oximetry sensor 130 are secondary peripheral sensors).
Regarding claim 4, the Embert and Hayes-Gill combination discloses the sensor network of claim 3, wherein the first sensor system is configured to detect a fetal heart rate (FHR), uterine contraction, and/or a maternal heart rate (Embert, par. [00035]: Doppler and/or ultrasound probe 135 may be configured to be placed on the abdomen of the pregnant mammal…and may provide information regarding fetal…heart rate).
Regarding claim 5, the Embert and Hayes-Gill combination discloses the sensor network of claim 4, wherein the sensor member of the first sensor system comprises an onboard wireless Doppler ultrasound (US) device for continuously acoustic detection of the FHR (Embert, par. [00035]: The Doppler and/or ultrasound probe 135 may be configured to be placed on the abdomen of the pregnant mammal and may be of a size and shape that approximates a silver U.S. dollar coin and may provide information regarding fetal… heart rate).
Regarding claim 8, the Embert and Hayes-Gill combination sensor network of claim 5, wherein the sensor member of the first sensor system further comprises an electromyograph (EMG) sensor for detection of the uterine contraction frequency and intensity, electrocardiograph (ECG) sensor for simultaneously detection of the fetal ECG and the maternal ECG (Embert, par. [00035]: ECG device 170 may be used to determine the pregnant mammal’s and/or fetus’ heart rate), and/or an accelerometer for measuring body position and/or physical activity.
Regarding claim 10, the Embert and Hayes-Gill combination discloses the second sensor system is configured to detect a maternal heart rate and/or a respiratory rate (RR) (Embert, par. [00058]: …fourth detector 160D may be used to determine…signal/information for the pregnant mammal (e.g., motion artifact, maternal respiratory signal, or pregnant mammal heartbeat information)).
Regarding claim 11, the Embert and Hayes-Gill combination discloses the sensor network of claim 10, wherein the sensor member of the second sensor system comprises one or more of: a motion-sensing unit for detecting seismocardiogram (SCG) and chest wall movements for respiratory rate (RR) (Embert, par. [00066]: …the detected electronic signals may include portions, or signals, that are contributed by different sources including, but not limited to, maternal respiration…uterine tone changes); and an ECG sensor for detecting the maternal heart rate (par. [00035]: ECG device 170 may be used to determine the pregnant mammal’s and/or fetus’ heart rate).
Regarding claim 12, the Embert and Hayes-Gill combination discloses the sensor network of claim 11, except wherein the motion-sensing unit comprises a 3-axial accelerometer, and/or an inertial measurement unit (IMU).
However, Hayes-Gill in the same field of endeavor: fetal movement monitor, discloses the motion-sensing unit comprises a 3-axial accelerometer (par. [0074]: … the movement sensor is a 3D accelerometer having three independent sensors each capable of detecting motion or movement in one of the three Cartesian coordinate axes), and/or an inertial measurement unit (IMU) (par. [0073]: …the maternal movement sensor comprises an accelerometer. However...Various activity instruments, sensors, or transducers are possible, such as…an inertial motion sensor…) for the purpose of detecting coarser or gross movement by the mother (par. [00073]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with multiple sensors of Embert and Hayes-Gill, maternal movement sensors that comprise an accelerometer or inertial motion sensor, as taught by Hayes-Gill in order to detect coarse or gross movement by the mother.
Regarding claim 13, the Embert and Hayes-Gill combination discloses the sensor network of claim 12. While Embert discloses that measurements provided by sensing units may be used in conjunction (par. [0058]) and that detected signals may include portions of signals that are contributed by different sources including motion artifact (par. [0088]) and that filtering of the signals may include removing motion artifacts (par. [0078]), Embert does not disclose the sensors are accelerometer or the IMU.
Hayes-Gill discloses the sensors are accelerometer or the IMU (pars. [0073-0074]) for the purpose of detecting coarser or gross movement by the mother ([0073]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to employ 3-D accelerometer or IMU maternal movement sensors of Hayes-Gill to detect and remove motion artifact as taught by Embert and Hayes-Gill in order to detect coarse or gross movement by the mother.
Regarding claim 15, the Embert and Hayes-Gill combination discloses the sensor network of claim 10, wherein the third sensor system is configured to detect photoplethysmogram (PPG) (Embert, Fig. 2B and par. [00058]: …first and/or fourth …detector(s) 160A and 160D…may be used to, for example, determine motion artifacts of the pregnant mammal, maternal photoplethysmogram information (e.g., photoplethysmogram variation)).
Regarding claim 16, the Embert and Hayes-Gill combination discloses the sensor network of claim 15, wherein the sensor member of the third sensor system comprises a pulse oximetry (Embert, par. [00026]: …fetal hemoglobin probe 115 may be a…pulse oximeter) for detecting blood oxygenation (SpO2) (Embert, par. [0032]: …fetal hemoglobin oxygen saturation level may be determined).
Regarding claim 17, the Embert and Hayes-Gill combination discloses the sensor network of claim 16, wherein the pulse oximetry comprises a light emitted diode (LED) (Embert, Fig. 1 (105) and par. [00028]: Light source(s) 105 may be, for example, a LED…) and a photodetector (Embert, Fig. 1 (105) (160) and pars. [0005]: …Each of the plurality of detected electronic signals may be received from…a photodetector)).
Regarding claim 18, the Embert and Hayes-Gill combination discloses the sensor network of any one of claims 1-17, wherein each of the plurality of sensor systems further comprises a power module coupled to the BLE SoC for providing power to said sensor system (Embert, par. [00025]: Electrical power may be supplied to system 100 and/or any component thereof via, for example, an on-board power supply …)).
Regarding claim 19, the Embert and Hayes-Gill combination discloses the sensor network of claim 18, wherein the power module comprises a power management integrated circuit (PMIC) coupled to the BLE SoC, and a battery coupled to the PMIC for providing power to said sensor system (Embert, par. [00025]: The components of system 100 may be coupled together via…wireless…communication links…wireless communication…may be enabled using short-range wireless communication protocols designed to communicate over relatively short distances (e.g., BLUETOOTH®…, for example, a computer or personal electronic device (e.g., tablet computer or smart phone)…Electrical power may be supplied to system 100 and/or any component thereof …).
Regarding claim 20, the Embert and Hayes-Gill combination discloses the sensor network of claim 19, wherein the battery is a rechargeable battery (Embert, par. [00025]: In some instances, a battery may be rechargeable).
Regarding claim 29, Embert discloses the sensor network of claim 1, wherein the controller is configured to perform at least one function of:
receiving and processing the detected data of the physiological parameters from the plurality of sensor systems (Embert, Fig. 5 (505) and par. [00038] Receiver 145 may be configured to receive signals and/or data from one or more components of system 100 including, but not limited to, fetal hemoglobin probe 1 15, [00041]: Receiver 145 may communicate received…processed signals to computer 150);
displaying the processed data of the physiological parameters in real time (Embert, par. [00041]: Computer 150 may act to process the received signals…and facilitate provision of the results to a display device 155…Exemplary display devices 155 are computer monitors, tablet computer devices, and displays provided by one or more of the components of system 100); and
transmitting the processed data of the physiological parameters to at least one of a patient database, a cloud server, and a mobile device (Embert, par. [00041]: Receiver 145 may communicate received…processed signals to computer 150…Exemplary computers 150 include desktop and laptop computers, servers, tablet computers, personal electronic devices, mobile devices (e.g., smart phones), and the like).
While Embert discloses continuously monitoring one or more critical parameters associating at least one vital sign (Embert, Fig. 1 and par. [00035]: ECG device 170 may be used to determine the pregnant mammal’s and/or fetus’ heart rate…system 100 may further include an intrauterine pulse oximetry probe (not shown) that may be used to determine the fetus’ heart rate. The Doppler and/or ultrasound probe 135…may provide information regarding fetal position, orientation, and/or heart rate. Pulse oximetry probe…to measure the pregnant mammal’s hemoglobin oxygen saturation) Embert fails to disclose notifying a practitioner or caregiver when a sensor aberrant signal output condition occurs; and
generating an alarm when an alarming vital sign reading condition in which the one or more of the critical parameters are out of pre-defined ranges occurs, and notifying a practitioner or caregiver of the alarm.
Hayes-Gill discloses notifying a practitioner or caregiver when a sensor aberrant signal output condition occurs; and
generating an alarm when an alarming vital sign reading condition in which the one or more of the critical parameters are out of pre-defined ranges occurs, and notifying a practitioner or caregiver of the alarm (par. [0034]: The processor may compare the log of fetal movements to one or more predetermined threshold values, such as a predetermined count or rate of fetal movement and may output an alarm or a signal indicative of abnormal or reduced fetal movement if the log of fetal movement is below or outside of said predetermined threshold values; an alarm is output when the critical parameter of fetal movement is out of pre-defined threshold values) to provide the benefit of a useful medical record for the clinician or midwife to use in determining the wellbeing of the fetus and/or mother (par. [0109]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the continuous monitoring of a parameter of Embert an alarm output when the monitored parameter is out of as taught by Hayes-Gill in order to provide the benefit of a useful medical record for the clinician or midwife to use in determining the wellbeing of the fetus and/or mother.
Regarding claim 31, the Embert and Hayes-Gill combination discloses the sensor network of claim 29, wherein the one or more critical parameters are one or more of the heart parameters , temperature, body movements, respiratory parameters, oxygenation, and blood pressure (Embert, par. [0035]: System 100 includes a number of optional independent sensors… probes/sensors are a NIRS adult hemoglobin probe 125, a pulse oximetry probe 130, a Doppler and/or ultrasound probe 135, a uterine contraction measurement device 140, and an electrocardiography (ECG) device 170).
Regarding claim 32, the Embert and Hayes-Gill combination discloses the sensor network of claim 29, wherein the controller is configured to further perform at least one function of: assessing the physiological signs of the fetus and the mother during labor, based on the detected physiological parameters (Embert, par. [000101]: …use of the systems, devices, and methods described herein may be particularly useful during the labor and delivery of the fetus (e.g., during the first and/or second stage of labor)).
Regarding claim 33, Embert discloses the sensor network of claim 29, except wherein the controller comprises a mobile device operable serving as a base station for Bluetooth communication.
Hayes-Gill discloses the controller comprises a mobile device (par. [0093]: …local receiving device is provided in the form of a portable communications device 34, which may comprise a mobile phone, smartphone, PDA, tablet…) operable serving as a base station for Bluetooth communication (Fig. 3 and par. [0094]: The monitoring device on the mother's abdomen transmits the processed data via a radio signal (e.g. Wi-Fi, Bluetooth®, Bluetooth Low Energy or suitable standard, such as a mobile telephony standard) to the device 34) for the purpose of providing a medical record for use by a mother in a home environment (par. [0123]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include as the controller of the continuous monitoring device of Embert a mobile device, such as smartphone, PDA or tablet, operable with Bluetooth as taught by Hayes-Gill in order provide a medical record for use by a mother, for example in a home environment.
Regarding claims 34 and 35, Embert discloses the sensor network of claim 33, except wherein the mobile device in bi-directionally wireless communication with the plurality of sensor systems; and
wherein the mobile device is a hand-held device or a portable device having a graphical user interface to display the physiological parameters.
Hayes-Gill discloses the mobile device in bi-directionally wireless communication with the plurality of sensor systems (par. [0094]: The monitoring device on the mother's abdomen transmits the processed data via a radio signal (e.g. Wi-Fi, Bluetooth®, Bluetooth Low Energy …) to the device 34… a Bluetooth® link is used such that the monitor device and the device 34 can be paired and can subsequently transmit/receive as required) ; and
wherein the mobile device is a hand-held device or a portable device having a graphical user interface to display the physiological parameters ((par. [0129]: … general purpose devices, such as mobile phones, PDA's, laptops, tablet computers, programmable media players or the like may provide useful, readily-available hardware for implementing the user interface aspect of the invention) to provide the benefit of ongoing monitoring of a mother's perceived sensations of fetal movement in the event that the time of recordal of a perceived fetal movement may be required (par. [0129]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include as the controller of the continuous monitoring device of Embert bidirectional communication using a mobile device, such as smartphone, PDA or tablet, operable with Bluetooth as taught by Hayes-Gill in order provide the benefit of ongoing monitoring of a mother's perceived sensations of fetal movement in the event that the time of recordal of a perceived fetal movement may be required.
Regarding claim 36, the Embert and Hayes-Gill combination discloses the sensor network of claim 1, wherein the physiological parameters comprise one or more of a maternal heart rate, a respiratory rate, a core body temperature, a peripheral temperature, a blood oxygenation, a blood pressure, uterine contraction frequency and intensity, and a fetal hear rate (Embert, pars. [0008]: a separated signal that corresponds to light incident upon the pregnant mammal (e.g., maternal photoplethysmogram, a maternal respiratory signal, a uterine tone signal, etc.) may be analyzed…, [00058]: …a first type of signal/information for the pregnant mammal (e.g., photoplethysmogram information) and fourth detector 160D may be used to determine a second type of signal/information for the pregnant mammal (e.g., …maternal respiratory signal, or pregnant mammal heartbeat information)).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1) in view of Hayes-Gill et al. (US 2016/0058363 A1), as applied to claims 1-5, 8, 10-13, 15-20, 29 and 31-36 above, and further in view of Roham et al. (US 2012/0232398 A1, hereinafter "Roham").
Regarding claims 6-7, the Embert and Hayes-Gill combination discloses the sensor network of claim 5, except wherein the first sensor system further comprises a piezoelectric transducer incorporated as a transmitter and receiver for a Doppler effect; and
wherein the piezoelectric transducer is tuned to resonate at about 3 MHz.
Roham, in the same field of endeavor: wireless fetal monitoring system, discloses a piezoelectric transducer incorporated as a transmitter and receiver for a Doppler effect (Fig. 3 (30) and par. [0059]: …wireless fetal monitoring system …uses a fetal heartbeat detector, such as an ultrasound Doppler detector… the fetal heartbeat detector (ultrasound piezoelectric transducer in one implementation of an ultrasound Doppler detector)…).
wherein the piezoelectric transducer is tuned to resonate at about 3 MHz (par. [0059]: …the fetal heartbeat detector (ultrasound piezoelectric transducer in one implementation of an ultrasound Doppler detector), operating at the frequency in the range of 1-10 MHz) for the purpose of detecting fetal heartbeat, and to provide an audio feedback to help positioning of the ultrasound device during monitoring (par. [0068]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the Doppler ultrasound sensor of Embert and Hayes-Gill, an ultrasound piezoelectric transducer with frequency range of 1-10 MHz, as taught by Roham, in order to detect fetal heartbeat, and to provide an audio feedback to help positioning of the ultrasound device during monitoring.
Claim(s) 9, 24 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1) in view of Hayes-Gill et al. (US 2016/0058363 A1), as applied to claims 1-5, 8, 10-13, 15-20, 29 and 31-36 above, and further in view of Baxi (US 2019/0209028 A1).
Regarding claim 9, the Embert and Hayes-Gill combination discloses the sensor network of claim 8, except wherein the ECG sensor has at least two electrodes for ECG generation, wherein the at least two electrodes are adjustable in spacing.
However, Baxi in the same field of endeavor: methods and devices for sensing biological function using a flexible, stretchable patch, discloses the ECG sensor has at least two electrodes for ECG generation (Fig. 3 (310)), wherein the at least two electrodes are adjustable in spacing (pars. [0028]: …The system 300 as illustrated includes a flexible, stretchable patch 302…, [0029]: Stretchable connotes an ability to lengthen, [0030] …patch 302 a… includes…stretchable, flexible fabric 306, a flexible, stretchable substrate material 308 on the fabric 306, [0035]: The ECG electrodes 310 can be low-profile, thin, stretchable…; because electrodes are stretchable with stretchable material in between them, the space in between the ECG electrodes 310 can be lengthened or adjusted) to provide the benefit of adjustable ECG electrodes in a patch setting that can withstand more force in being stretched, bent, rotated, poked, or otherwise having force exerted thereon (par. [0030]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with ECG sensors of Embert and Hayes-Gill, stretchable and hence adjustable ECG electrodes as taught by Baxi in order to provide the benefit of adjustable ECG electrodes in a patch setting that can withstand more force in being stretched, bent, rotated, poked, or otherwise having force exerted thereon.
Regarding claim 24, the Embert and Hayes-Gill combination discloses the sensor network of claim 18, except wherein each of the plurality of sensor systems further comprises:
a plurality of flexible and stretchable interconnects electrically connecting to a plurality of electronic components including the sensor member, the BLE SoC and the power module; and
an elastomeric encapsulation layer at least partially surrounding the electronic components and the flexible and stretchable interconnects to form a tissue-facing surface attached to the subject and an environment-facing surface, wherein the tissue-facing surface is configured to conform to a skin surface of the pregnant woman
Baxi discloses each of the plurality of sensor systems (Fig. 3 (310)) further comprises:
a plurality of flexible and stretchable interconnects electrically connecting to a plurality of electronic components (par. [0035]: …the interconnect between the fabric 306 and the substrate 308) including the sensor member, the BLE SoC and the power module (par. [0025]: The sensor may be a plastic adhesive strip applied…); and
an elastomeric encapsulation layer at least partially surrounding the electronic components and the flexible and stretchable interconnects (Fig. 9 (308) and par. [0091]: …the substrate includes an elastomer material) to form a tissue-facing surface (par. [0025]: …the ECG sensors and the PPG sensors together onto a flexible, stretchable substrate…single patch which sticks to a surface, such as human or other animal skin (see FIG. 9) attached to the subject and an environment-facing surface (Fig. 9 (308) and par. [0091]: …the substrate includes an elastomer material), wherein the tissue-facing surface is configured to conform to a skin surface of the pregnant woman (par. [0028]: The body-side view includes a view of the patch 302 as it would look from a viewer looking out from a surface of skin of an entity wearing the patch 302) to provide the benefit of increasing the stretchability and/or flexibility of the patch (par. [0034]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with multiple sensors of Embert and Hayes-Gill, flexible, stretchable elastomeric materials and interconnects, as taught by Baxi, in order to increase the stretchability and/or flexibility of the patch.
Regarding claim 26, the Embert and Hayes-Gill combination discloses the sensor network of claim 24, except wherein the encapsulation layer is formed of a flame retardant material.
Baxi discloses the encapsulation layer is formed of a flame retardant material (par. [0031]: The substrate material 308 can include a material, such as thermo-plastic polyurethane (TPU), silicone and/or polydimethylsiloxane (PDMS), poly (lactic acid) based polymers or co-polymers, other bio-compatible tri-block copolymers, thermosets (e.g., polyuria), polydimethylsiloxane (PDMS), among others; ; PDMS is a flame retardant material) for the purpose of providing a medium that can be attached to fabric by heat pressing (par. [0031]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with multiple sensors of Embert and Hayes-Gill, flexible, stretchable elastomeric materials that are flame retardant such as PDMS as taught by Baxi in order to provide a medium that can be attached to fabric by heat pressing.
Regarding claim 27, the Embert and Hayes-Gill combination discloses the sensor network of claim 26, wherein the elastomeric encapsulation layer is a waterproof and biocompatible silicone enclosure.
Baxi discloses the elastomeric encapsulation layer is a waterproof and biocompatible silicone enclosure (par. [0052]: The cover 702 can include a material that resists static and/or is water or sweat proof/resistant…cover 702, in one or more embodiments includes a polymer, plastic, or other water-impermeable material) for the purpose of protecting the components under the cover (par. [0052]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with multiple sensors of Embert and Hayes-Gill, flexible, stretchable elastomeric materials that are waterproof as taught by Baxi in order to protect the components under the cover.
Regarding claim 28, the Embert and Hayes-Gill combination discloses the sensor network of claim 24, except wherein each of the first and second sensor systems further comprises a biocompatible hydrogel adhesive for attaching said sensor system on the respective region of the subject, wherein the biocompatible hydrogel adhesive is adapted such that signals from the subject are operably conductible to said sensor system.
Baxi discloses each of the first and second sensor systems further comprises a biocompatible hydrogel adhesive for attaching said sensor system on the respective region of the subject (par. [0073]: The fabric 306 of the patch system 300, 500, 800, or 1000 can be attached to the skin using a bio-compatible adhesive film (e.g., a silicon adhesive sheet, spray, or other attachment mechanism), wherein the biocompatible hydrogel adhesive is adapted such that signals from the subject are operably conductible to said sensor system (par. [0073]: The attachment mechanism can be situated on the body side of the patch (i.e. the side shown in FIG. 3)) to provide the benefit of a stronger bio-signal detection (par. [0073]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with multiple sensors of Embert and Hayes-Gill, sensors with bio-compatible adhesive as taught by Baxi in order to provide the benefit of a stronger bio-signal detection.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1) in view of Hayes-Gill et al. (US 2016/0058363 A1), as applied to claims 1-5, 8, 10-13, 15-20, 29 and 31-36 above, and further in view of Bajtala et al. (US 2021/0076980 A1, hereinafter, "Bajtala").
Regarding claim 14, the Embert and Hayes-Gill combination discloses the sensor network of claim 11, except wherein the BLE SoC is configured to operably control the motion-sensing unit through one of a serial peripheral interface (SPI) communication protocol and an inter-integrated circuit (I2C) communication protocol, and to operably control the thermometer through the other of the SPI and the I2C communication protocols.
However, Bajtala in the same field of endeavor: medical device with SOC controlling, discloses a microcontroller in the form of an SoC comprising a BLE radio module (par. [0128]) where the acceleration sensor (15) is a 3-axis sensor (15.1) may communicate with the microcontroller (14) via a common inter-integrated circuit bus (I2C bus), or I2C interface (par. [0115]). While the communication of the thermal fluid flow sensor (13, 13.1, 13.2) with the microcontroller (14) is achieved via a SPI bus (serial peripheral interface) (par. [0108]) for the purpose of allowing real time display of the measured data (par. [0130]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with BLE Soc and multiple sensors of Embert and Hayes-Gill, an acceleration motion sensor and thermal sensor with BLE SoC that communicates with SPI and I2C communication protocols as taught by Bajtala in order to allow real time display of the measured data.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1) in view of Hayes-Gill et al. (US 2016/0058363 A1), as applied to claims 1-5, 8, 10-13, 15-20, 29 and 31-36 above, and further in view of Bhushan et al. (US 2017/0347894 A1, hereinafter, "Bhushan").
Regarding claim 21, the Embert and Hayes-Gill combination discloses the sensor network of claim 20, except wherein the power module further comprises a wireless charging module coupled to the PMIC for wirelessly charging the rechargeable battery.
However, Bhushan in the same field of endeavor: continuous monitoring of a physiological parameter, discloses the power module further comprises a wireless charging module coupled to the PMIC for wirelessly charging the rechargeable battery (par. [0037]: The system includes a wearable device and corresponding computing device. The wearable device (hereon referred to as the “Biostrip” device) includes an electronic module or a component that is reusable and rechargeable (via micro-USB or wirelessly or both), [0038]: The system includes one or more small wearable, rechargeable Biostrips, along with…a wireless recharging coil…) to provide the benefit of continuous monitoring of a user's health with no interruption to recharge (par. [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy sensing network with battery module of Embert and Hayes-Gill, a wireless recharging battery as taught by Bhushan in order to provide the benefit of continuous monitoring of a user's health with no interruption to recharge.
Regarding claim 22, the Embert and Hayes-Gill combination discloses the sensor network of claim 21, except wherein the wireless charging module comprises a near- field communication (NFC) antenna.
the wireless charging module comprises a near- field communication (NFC) antenna (Fig. 1 (107) and par. [0009]: …gateway device trough wireless communication such as Bluetooth (a trademark of Bluetooth SIG, Inc.), ZigBee (a trademark of the Zigbee Alliance) or other Near-Field Communication (“NFC”) protocol) to provide the benefit of continuous monitoring of a user's health with no interruption to recharge (par. [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy sensing network with battery module of Embert and Hayes-Gill, a wireless recharging battery comprising NFC as taught by Bhushan in order to provide the benefit of continuous monitoring of a user's health with no interruption to recharge.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1) in view of Hayes-Gill et al. (US 2016/0058363 A1),as applied to claims 1-5, 8, 10-13, 15-20, 29 and 31-36 above, and further in view of Kobayashi et al. (US 2019/0133463, hereinafter "Kobayashi").
Regarding claim 23, the Embert and Hayes-Gill combination discloses the sensor network of claim 19, except wherein the power module further comprises a failure prevention element including a short-circuit protection component or a circuit to avoid battery malfunction.
However, Kobayashi, in the same field of endeavor: continuous measure of physiological parameters using piezoelectric elements, discloses the power module further comprises a failure prevention element including a short-circuit protection component (par. [0078]: …a conductive resin 78 is provided in a manner covering the insulating resin 76. As a result, the conductive resin 78 abates the humming noise from the top face of the piezoelectric element 30, while the circuit around the piezoelectric element 30 is insulated, and this reduces the humming noise without causing the circuit to fail (short)) for the purpose of releasing electrical noise to the ground and obtaining pulse wave signals of higher definition (par. [0079]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy sensing network power module of Embert and Hayes-Gill, a circuit fail element as taught by Kobayashi in order to release electrical noise to the ground and obtaining pulse wave signals of higher definition.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1) in view of Hayes-Gill et al. (US 2016/0058363 A1) and Baxi (US 2019/0209028 A1), as applied to claims 9, 24 and 26-28 above, and further in view of Bhushan et al. (US 2017/0347894 A1, hereinafter, "Bhushan").
Regarding claim 25, the Embert, Hayes-Gill and Baxi combination discloses sensor network of claim 24, except wherein each of the plurality of sensor systems further comprises one or more foldable electronic boards, wherein the plurality of electronic components and the plurality of flexible and stretchable interconnects are disposed on the one or more foldable electronic boards.
Bhushan discloses each of the plurality of sensor systems further comprises one or more foldable electronic boards, wherein the plurality of electronic components and the plurality of flexible and stretchable interconnects are disposed on the one or more foldable electronic boards (Fig. 3 and par. [0038]: …Biostrip is constructed on three hard printed circuit boards (“PCBs”) connected by two flexible connecting PCBs that contain a number of physiological monitors…) to allow the device to be placed on and adhere to irregular surfaces (par. [0031]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the pregnancy monitoring device with multiple sensors of Embert, Hayes-Gill and Baxi sensors with flexible, stretchable interconnects and PCBs as taught by Bhushan in order to provide the benefit of a stronger bio-signal detection.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embert (WO 2019/133926 A1) in view of Hayes-Gill et al. (US 2016/0058363 A1), as applied to claims 1-5, 8, 10-13, 15-20, 29 and 31-36 above, and further in view of Greenberg et al. (Publication No. WO 00/54650 A2, hereinafter "Greenberg", cited by Applicant).
Regarding claim 30, the Embert and Hayes-Gill combination discloses the sensor network of claim 29, except wherein said processing the detected data of the physiological parameters comprises: processing the output signals of the second and third sensor systems to determine a pulse arrival time (PAT) and a pulse transit time (PTT) so as to obtain the blood pressure;
eliminating the maternal ECG from the outputs of the first sensor system allowing for fetal ECG isolation ;
and/or processing the output signals of the first and second sensor systems to subtract motion artifact in physiological signal calculations for respiratory rate and/or heart rate.
However, Greenberg, in the same field of endeavor: non-invasive fetal heart monitoring, discloses processing the detected data of the physiological parameters comprises:
processing the output signals of the second and third sensor systems to determine a pulse arrival time (PAT) and a pulse transit time (PTT) so as to obtain the blood pressure; eliminating the maternal ECG from the outputs of the first sensor system allowing for fetal ECG isolation (pg. 5, lns. 15-20: The method includes the steps of measuring at least one biopotential waveform indicative of the mother's heart beat to form a maternal waveform, measuring at least one biopotential waveform indicative of the combined maternal and fetal heart beats to form a combined biopotential waveform, and using signal processing to cancel the maternal waveform from the combined waveform to derive a fetal waveform indicative of the fetus' biopotential electrocardiographic waveform (EKGf));
and/or processing the output signals of the first and second sensor systems to subtract motion artifact in physiological signal calculations for respiratory rate and/or heart rate (pg. 6, lns. 11-13: The invention provides patient information (e.g., fetal heart rate/variability, taking into account noise artifacts attributable to uterine contractions) that at least duplicates current clinical standards…invention uses...suitable skin contact electrodes connected to amplifiers to acquire biopotential waveforms and form signals, preferably differential signals, indicative of the mother's heart beat from sensors, e.g., electrodes…as well as electromyographic signatures indicative of noise artifacts attributable to changes in uterine tone) to provide the benefit of non-invasively and passively measuring fetal and maternal electrocardiographic and maternal electromyographic waveforms using traditional surface electrode electrocardiographic and electromyographic techniques (pg. 6, lns. 7-10).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the controller of the pregnancy monitoring sensor network of Embert and Hayes-Gill, processing maternal waveform signal and the combined maternal and fetal signal to derive the fetal signal in order to non-invasively and passively measuring fetal and maternal electrocardiographic and maternal electromyographic waveforms using traditional surface electrode electrocardiographic and electromyographic techniques.
Conclusion
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/AAA/ Examiner, Art Unit 3796
/BRIAN T GEDEON/ Primary Examiner, Art Unit 3796 8 November 2024
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