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 Amendment
In response to amendments filed November 3, 2025, claims 1 and 19-20 are amended. No claims are cancelled or added. Claims 1 and 3-20 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed November 3, 2025, with respect to the objection to the drawings have been fully considered and are persuasive in view of the amended drawings. The drawing objections have been withdrawn.
Applicant’s arguments with respect to the prior art rejection(s) have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Stein/Kinnunen/Kang/Kodama in further view of Pardey, Euliano, Payne, Rang, Moors, or Silva.
Claim Rejections - 35 USC § 103
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, 9-10, 13-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1).
Regarding claim 1, Stein teaches a method (Stein: [0001] “method for detecting events related to a pregnancy of a female human”). However, Stein fails to disclose a ring. Kinnunen teaches a method including collecting temperature information from a wearable ring. The combination of Stein/Kinnunen discloses comprising:
acquiring, via one or more temperature sensors of a wearable ring device configured to be worn by a user that is pregnant, physiological data associated with the user; receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user that is pregnant, the physiological data comprising at least temperature data (Stein: Fig. 1, wearable device 1, sensor system 100, optical sensors 101, sensor system 102 with one or more accelerometers, bioimpedance sensor system 103, temperature sensor system 104; [0041] “In FIG. 1, reference numeral 4 refers to a mobile communication device, e.g. a cellular telephone or a tablet or laptop computer;” Kinnunen: ring 102; [0119] “the wearable electronic device of the system is a ring configured to be suitably worn on a finger, such as an index finger, of the user” [0120] “the wearable electronic device may comprise … a temperature sensor for measuring the temperature of the user. The wearable electronic device may include any number and types of sensors suitable for collecting data about the user. The measured sensor data from any of the sensors, such as the data of the motion sensor, the optical electronics, the light sensor and the temperature sensor, associated with the user and measured by the wearable electronic device may be considered as raw sensor data.”);
determining a time series of a plurality of temperature values taken over a plurality of days based at least in part on the temperature data (Stein: [0072] “skin temperature, time windows W1 and W2”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Stein to include a wearable ring device as disclosed in Kinnunen to easily and reliably acquire continuous user data (Kinnunen [0007, 0119]).
However, the combination of Stein/Kinnunen fails to disclose a decrease and then increase of temperature values relative to a baseline. Kang teaches monitoring pregnancy status by collecting continuous user temperature. The combination of Stein/Kinnunen/Kang discloses:
calculating, using historical temperature data representative of average physiological values, a pregnancy baseline of temperature values for the user for at least a portion of the plurality of days (Kang: Pg 4 [1] “baseline model,” [7] “in a normal menstrual cycle 28 days, normal temperature 36.6 ℃”);
computing a deviation in the time series of the plurality of temperature values relative to the pregnancy baseline of temperature values based at least in part on determining the time series and calculating the pregnancy baseline of temperature values, wherein the deviation comprises a decrease in the plurality of temperature values from the pregnancy baseline of temperature values for a first portion of time and an increase in the plurality of temperature values from the pregnancy baseline of temperature values for a second portion of time following the first portion; identifying that one or more positive slopes of the plurality of temperature values deviates from the pregnancy baseline of temperature values for the user based at least in part on computing the deviation (Stein: [0072] “decreases by defined threshold;” Kang: Fig. 5 shows values lower than the normal temperature 36.6 ℃ up until day 15, after which, per Pg 4 [15] “in FIG. 5, high temperature from the first 15 days for the first 34 days [higher than normal temperature 36.6 ℃] and 20 days after cooling, which generally is considered evidence of early abortion”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen to include a decrease and then increase of temperature values relative to a baseline as disclosed in Kang to identify potential pregnancy complications such as early abortion (Kang Pg 4 [15]).
However, the combination of Stein/Kinnunen/Kang fails to disclose a positive slope of the pregnancy baseline.
Kodama teaches a method and apparatus for determining the possibility of pregnancy according to temperature and bioelectrical impedance. Kodama discloses a positive slope of the pregnancy baseline of temperature values (Kodama: Fig. 2, slope increase in line (a); [0004] “As shown in FIG. 2, the basal body temperature shows a noticeable change when the woman is pregnant. Specifically the basal body temperature rises on the ovulation day, and it remains at a high-temperature level until the beginning day of the menstruation period to lower gradually if the woman is not pregnant (see broken line on curve (a) ) whereas the basal body temperature is remaining high for the menstruation period if the woman is pregnant (see solid line on curve (a)).”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang to include a positive slope of the pregnancy temperature baseline as disclosed in Kodama to accurately reflect the time-sequence transition of a woman’s basal body temperature in pregnancy (Kodama [0004]).
The combination of Stein/Kinnunen/Kang/Kodama discloses:
detecting an indication of one or more pregnancy complications of the user based at least in part on identifying that the plurality of temperature values deviate from the pregnancy baseline of temperature values for the user (Stein: [0072] “detect the occurrence of miscarriage of the female user, by checking whether the heart rate of the female user and/or the skin temperature of the female user decreases by a defined threshold value ... The difference is detected between a first average value of the respective physiological parameter in a preceding, earlier time window (before the miscarriage), as indicated by time window W1 in FIG. 13, and a second average value of the respective physiological parameter in a subsequent, later time window (after the miscarriage), as indicated by time window W2 in FIG. 13. For example, the duration of the earlier time window W1 is seven days [before the miscarriage], and the duration of the later time window W2 is five days. The two consecutive time windows W1, W2;” Kang: Fig. 5; Pg 4 [15] “in FIG. 5, high temperature from the first 15 days for the first 34 days [higher than normal temperature 36.6 ℃] and 20 days after cooling, which generally is considered evidence of early abortion”);
and generating a message for display on a graphical user interface on the user device that indicates the indication of the one or more pregnancy complications (Stein: [0063] “a detected pregnancy related event … is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16”).
Regarding claim 9, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), further comprising:
receiving a confirmation of the one or more pregnancy complications, one or more pregnancy symptoms, or both, wherein detecting the indication of the one or more pregnancy complications is based at least in part on receiving the confirmation (Stein: Fig. 2, ui1, ui2, ui3; [0053] “Step S1 is executed on an ongoing basis and comprises the capturing of physiological parameters and user input [aka confirmation] used for detecting pregnancy related events for a female user”).
Regarding claim 10, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), further comprising:
determining each temperature value of the plurality of temperature values based at least in part on receiving the temperature data (Stein: temperature sensor system 104), wherein the temperature data comprises continuous nighttime temperature data (Stein: [0044] “sleep phase analysis;” [0004] “monitoring of events on the journey to pregnancy can be continuously assessed;” [0072] “difference is detected between a first average value of the respective physiological parameter in a preceding, earlier time window …, and a second average value of the respective physiological parameter in a subsequent, later time window ... For example, the duration of the earlier time window W1 is seven days (before the miscarriage), and the duration of the later time window W2 is five days – [continuous assessment of temperature data over the course of multiple days inherently includes continuous nighttime temperature data”).
Regarding claim 13, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), further comprising:
transmitting the message that indicates the indication of the one or more pregnancy complications to the user device, wherein the user device is associated with a clinician, the user, or both (Stein: [0063] “a detected pregnancy related event … is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16. Depending on the embodiment, the detected pregnancy related event or the expected time of the next menses, if applicable, is transmitted by the processor(s) 30 of the computer system 3 via network 2 to the wearable device 1 and/or the mobile communication device 4”).
Regarding claim 14, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), further comprising:
causing the graphical user interface of the user device associated with the user to display pregnancy complication symptom tags (Stein: [0010] “breathing rate of the female human, a heart rate of the female human, a skin temperature of the female human, a heart rate variability (HRV) parameter of the female human, and/or a perfusion of the female human”) based at least in part on detecting the indication of the one or more pregnancy complications (Stein: [0063] “a detected pregnancy related event … is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16; Fig. 2”).
Regarding claim 15, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), further comprising:
causing the graphical user interface of the user device associated with the user to display the message associated with the indication of the one or more pregnancy complications (Stein: [0063] “a detected pregnancy related event … is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16.”).
Regarding claim 16, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 15 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”),
wherein the message further comprises a time interval during which the one or more pregnancy complications occurred (Stein: [0036] “FIG. 13: shows a graph illustrating a set of consecutive sliding time windows for detecting a miscarriage in a conceptive cycle”),
a time interval during which the one or more pregnancy complications are predicted to occur (Stein: [0063] “In step S23, a detected pregnancy related event or the expected next menses, if applicable, is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16”),
educational content associated with the one or more pregnancy complications or a combination thereof (Stein: [0036] “FIG. 13: shows a graph illustrating a set of consecutive sliding time windows for detecting a miscarriage in a conceptive cycle; [0063] In step S23, a detected pregnancy related event or the expected next menses, if applicable, is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16”).
Regarding claim 17, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: Stein: [0001] “method for detecting events related to a pregnancy of a female human”), further comprising:
inputting the physiological data into a machine learning classifier, wherein detecting the indication of the one or more pregnancy complications is based at least in part on inputting the physiological data into the machine learning classifier (Stein: [0064] “continuously improve the detection of pregnancy related events, by adapting the detection criteria in response to the received user input ui1, ui2, ui3 [physiological data] which is related to the actual occurrence of pregnancy related events, employing machine learning algorithms including but not limited to Recurrent Neural Networks, Random Forest Classifiers and Hidden Markov Models and Support Vector Machines”).
Regarding claim 19, Stein teaches a system ([0039] FIG. 1 shows an electronic system 5 for detecting events related to a pregnancy of a female human). However, Stein fails to disclose a ring. The combination of Stein/Kinnunen discloses comprising:
a plurality of sensors of a wearable ring device configured to be worn on a finger of a user; and one or more processors communicatively coupled with the plurality of sensors (Stein: Fig. 1, wearable device 1, sensor system 100, optical sensors 101, sensor system 102 with one or more accelerometers, bioimpedance sensor system 103, temperature sensor system 104, processor 13, 30, 40; [0040] “The computer system 3 or its processors 30, respectively, are connected to the data storage system 31 and configured to execute various functions;” Kinnunen: ring 102; [0119] “the wearable electronic device of the system is a ring configured to be suitably worn on a finger, such as an index finger, of the user;” [0120] “the wearable electronic device may comprise … a temperature sensor for measuring the temperature of the user.”), wherein the one or more processors are configured to:
acquire, via one or more temperature sensors of a wearable ring device configured to be worn by a user that is pregnant, physiological data associated with the user; receive, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user that is pregnant, the physiological data comprising at least temperature data (Stein: Fig. 1, wearable device 1, sensor system 100, optical sensors 101, sensor system 102 with one or more accelerometers, bioimpedance sensor system 103, temperature sensor system 104; [0041] “In FIG. 1, reference numeral 4 refers to a mobile communication device, e.g. a cellular telephone or a tablet or laptop computer;” Kinnunen: ring 102; [0120] “the wearable electronic device may comprise … a temperature sensor for measuring the temperature of the user.”);
determine a time series of a plurality of temperature values taken over a plurality of days based at least in part on the temperature data ([0072] “skin temperature, time windows W1 and W2”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Stein to include a wearable ring device as disclosed in Kinnunen to easily and reliably acquire continuous user data (Kinnunen [0007, 0119]).
However, the combination of Stein/Kinnunen fails to disclose a decrease and then increase of temperature values relative to a baseline. Kang teaches monitoring pregnancy status by collecting continuous user temperature. The combination of Stein/Kinnunen/Kang discloses:
calculate, using historical temperature data representative of average physiological values, a pregnancy baseline of temperature values for the user for at least a portion of the plurality of days (Kang: Pg 4 [1] “baseline model,” [7] “in a normal menstrual cycle 28 days, normal temperature 36.6 ℃”);
compute a deviation in the time series of the plurality of temperature values relative to the pregnancy baseline of temperature values based at least in part on determining the time series and calculating the pregnancy baseline of temperature values, wherein the deviation comprises a decrease in the plurality of temperature values from the pregnancy baseline of temperature values for a first portion of time and an increase in the plurality of temperature values from the pregnancy baseline of temperature values for a second portion of time following the first portion; identify that one or more positive slopes of the plurality of temperature values deviates from the pregnancy baseline of temperature values for the user based at least in part on computing the deviation (Stein: [0072] “decreases by defined threshold;” Kang: Fig. 5 shows values lower than the normal temperature 36.6 ℃ up until day 15, after which, described on Pg 4 [15] “in FIG. 5, high temperature from the first 15 days for the first 34 days [higher than normal temperature 36.6 ℃] and 20 days after cooling, which generally is considered evidence of early abortion”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen to include a decrease and then increase of temperature values relative to a baseline as disclosed in Kang to identify potential pregnancy complications such as early abortion (Kang Pg 4 [15]).
However, the combination of Stein/Kinnunen/Kang fails to disclose a positive slope of the pregnancy baseline.
Kodama discloses a positive slope of the pregnancy baseline of temperature values (Kodama: Fig. 2, slope increase in line (a); [0004] “As shown in FIG. 2, the basal body temperature shows a noticeable change when the woman is pregnant. Specifically the basal body temperature rises on the ovulation day, and it remains at a high-temperature level until the beginning day of the menstruation period to lower gradually if the woman is not pregnant (see broken line on curve (a) ) whereas the basal body temperature is remaining high for the menstruation period if the woman is pregnant (see solid line on curve (a)).”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang to include a positive slope of the pregnancy temperature baseline as disclosed in Kodama to accurately reflect the time-sequence transition of a woman’s basal body temperature in pregnancy (Kodama [0004]).
The combination of Stein/Kinnunen/Kang/Kodama discloses:
detect an indication of one or more pregnancy complications of the user based at least in part on identifying that the plurality of temperature values deviate from the pregnancy baseline of temperature values for the user (Stein: [0072] “detect the occurrence of miscarriage of the female user, by checking whether the heart rate of the female user and/or the skin temperature of the female user decreases by a defined threshold value ... The difference is detected between a first average value of the respective physiological parameter in a preceding, earlier time window (before the miscarriage), as indicated by time window W1 in FIG. 13, and a second average value of the respective physiological parameter in a subsequent, later time window (after the miscarriage), as indicated by time window W2 in FIG. 13. For example, the duration of the earlier time window W1 is seven days [before the miscarriage], and the duration of the later time window W2 is five days. The two consecutive time windows W1, W2;” Kang: Fig. 5; Pg 4 [15] “in FIG. 5, high temperature from the first 15 days for the first 34 days [higher than normal temperature 36.6 ℃] and 20 days after cooling, which generally is considered evidence of early abortion”);
and generate a message for display on a graphical user interface on the user device that indicates the indication of the one or more pregnancy complications (Stein: [0063] “a detected pregnancy related event … is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16”).
Regarding claim 20, Stein teach a non-transitory computer-readable medium storing code, the code comprising instructions executable by one or more processors to (Stein: Fig. 1, data storage system 31; [0040] The computer system 3 or its processors 30, respectively, are connected to the data storage system 31 and configured to execute various functions)
However, Stein fails to disclose a ring. The combination of Stein/Kinnunen discloses to:
acquire, via one or more temperature sensors of a wearable ring device configured to be worn by a user that is pregnant, physiological data associated with the user; receive, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user that is pregnant, the physiological data comprising at least temperature data (Stein: Fig. 1, wearable device 1, sensor system 100, optical sensors 101, sensor system 102 with one or more accelerometers, bioimpedance sensor system 103, temperature sensor system 104; [0041] “In FIG. 1, reference numeral 4 refers to a mobile communication device, e.g. a cellular telephone or a tablet or laptop computer;” Kinnunen: ring 102; [0120] “the wearable electronic device may comprise … a temperature sensor for measuring the temperature of the user.”);
determine a time series of a plurality of temperature values taken over a plurality of days based at least in part on the temperature data ([0072] “skin temperature, time windows W1 and W2”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Stein to include a wearable ring device as disclosed in Kinnunen to easily and reliably acquire continuous user data (Kinnunen [0007, 0119]).
However, the combination of Stein/Kinnunen fails to disclose a decrease and then increase of temperature values relative to a baseline. Kang teaches monitoring pregnancy status by collecting continuous user temperature. The combination of Stein/Kinnunen/Kang discloses:
calculate, using historical temperature data representative of average physiological values, a pregnancy baseline of temperature values for the user for at least a portion of the plurality of days (Kang: Pg 4 [1] “baseline model,” [7] “in a normal menstrual cycle 28 days, normal temperature 36.6 ℃”);
compute a deviation in the time series of the plurality of temperature values relative to the pregnancy baseline of temperature values based at least in part on determining the time series and calculating the pregnancy baseline of temperature values, wherein the deviation comprises a decrease in the plurality of temperature values from the pregnancy baseline of temperature values for a first portion of time and an increase in the plurality of temperature values from the pregnancy baseline of temperature values for a second portion of time following the first portion; identify that one or more positive slopes of the plurality of temperature values deviates from the pregnancy baseline of temperature values for the user based at least in part on computing the deviation (Stein: [0072] “decreases by defined threshold;” Kang: Fig. 5 shows values lower than the normal temperature 36.6 ℃ up until day 15, after which, per Pg 4 [15] “in FIG. 5, high temperature from the first 15 days for the first 34 days [higher than normal temperature 36.6 ℃] and 20 days after cooling, which generally is considered evidence of early abortion”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen to include a decrease and then increase of temperature values relative to a baseline as disclosed in Kang to identify potential pregnancy complications such as early abortion (Kang Pg 4 [15]).
However, the combination of Stein/Kinnunen/Kang fails to disclose a positive slope of the pregnancy baseline.
Kodama teaches a method and apparatus for determining the possibility of pregnancy according to temperature and bioelectrical impedance. Kodama discloses a positive slope of the pregnancy baseline of temperature values (Kodama: Fig. 2, slope increase in line (a); [0004] “As shown in FIG. 2, the basal body temperature shows a noticeable change when the woman is pregnant. Specifically the basal body temperature rises on the ovulation day, and it remains at a high-temperature level until the beginning day of the menstruation period to lower gradually if the woman is not pregnant (see broken line on curve (a) ) whereas the basal body temperature is remaining high for the menstruation period if the woman is pregnant (see solid line on curve (a)).”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang to include a positive slope of the pregnancy temperature baseline as disclosed in Kodama to accurately reflect the time-sequence transition of a woman’s basal body temperature in pregnancy (Kodama [0004]).
The combination of Stein/Kinnunen/Kang/Kodama discloses:
detect an indication of one or more pregnancy complications of the user based at least in part on identifying that the plurality of temperature values deviate from the pregnancy baseline of temperature values for the user (Stein: [0072] “detect the occurrence of miscarriage of the female user, by checking whether the heart rate of the female user and/or the skin temperature of the female user decreases by a defined threshold value ... The difference is detected between a first average value of the respective physiological parameter in a preceding, earlier time window (before the miscarriage), as indicated by time window W1 in FIG. 13, and a second average value of the respective physiological parameter in a subsequent, later time window (after the miscarriage), as indicated by time window W2 in FIG. 13. For example, the duration of the earlier time window W1 is seven days [before the miscarriage], and the duration of the later time window W2 is five days. The two consecutive time windows W1, W2;” Kang: Fig. 5; Pg 4 [15] “in FIG. 5, high temperature from the first 15 days for the first 34 days [higher than normal temperature 36.6 ℃] and 20 days after cooling, which generally is considered evidence of early abortion”);
and generate a message for display on a graphical user interface on the user device that indicates the indication of the one or more pregnancy complications (Stein: [0063] “a detected pregnancy related event … is indicated to the user on a user interface of the wearable device 1 or the mobile communication device 4 by the processor 13 or 40, respectively, e.g. as an acoustical signal and/or a graphical representation on the display 16”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1), and in further view of Sun (DIO: 10.3892/etm.2019.8405).
Regarding claim 3, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), further comprising:
computing a photoplethysmography amplitude change of systolic and diastolic inflection points of a photoplethysmography waveform based at least in part on receiving the physiological data (Stein: [0043] “sensor system 101 comprises a PPG-based sensor system for measuring heart rate and heart rate variability”).
However, the combination of Stein/Kinnunen/Kang/Komada fails to disclose computing a photoplethysmography reflection index.
Sun (DIO: 10.3892/etm.2019.8405) teaches using photoplethysmographic assessment for identifying pregnancy‑induced hypertension (PIH) or pre‑eclampsia (PE). Sun discloses:
and identifying that a value of a photoplethysmography reflection index is greater than a value of a pregnancy baseline photoplethysmography reflection index based at least in part on computing the photoplethysmography amplitude change (Sun: pg 1955, col 1, [1] “Photoplethysmographic reflection index [PPG RI];” pg 1956, col 2, [6] “PIH [pregnancy‑induced hypertension] and PE [pre‑eclampsia] groups exhibited significantly higher … PPG RI [photoplethysmographic reflection index] values compared with the NP [normal pregnancy] group [all P<0.05;” Table II]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang/Komada to calculate and compare the photoplethysmography reflection index of the test groups with the PPG RI of the normal pregnancy group (baseline) as disclosed in Sun so that PPG could be used for identifying high-risk pregnancy (Sun: pg 1955, col 2, [1]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1), and in further view of Rang (DOI: 10.1016/j.ajog.2007.11.014).
Regarding claim 4, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), wherein the physiological data further comprises heart rate data (Stein: [0043] “optical sensors 101 configured to generate photoplethysmography [PPG] signals for measuring heart rate”). However, the combination of Stein/Kinnunen/Kang/Komada fails to disclose heart rate exceeding a pregnancy baseline.
Rang (DOI: 10.1016/j.ajog.2007.11.014) teaches serial hemodynamic measurement in normal pregnancy, preeclampsia, and intrauterine growth restriction. Rang discloses, the method further comprising:
determining that the heart rate data exceeds a pregnancy baseline heart rate for the user for at least the portion of the plurality of days, wherein detecting the indication of the one or more pregnancy complications is based at least in part on determining that the heart rate data exceeds the pregnancy baseline heart rate for the user (Rang Table 5, “Outcome of different studies of … heart rate (HR) … during the preclinical phase of preeclampsia or gestational hypertension, compared with women with uncomplicated pregnancies [pregnant women with preeclampsia or gestational hypertension have the same or higher heart rate vs pregnant women with uncomplicated pregnancies]”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang/Komada to include the connection between pregnancy complications and heart rate data exceeding a baseline as disclosed in Rang to enable selection of women at risk for the development of preeclampsia or fetal growth restriction (Rang Page 1, col 3, [2]).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1), and in further view of Moors (DOI: 10.1016/j.preghy.2020.03.003).
Regarding claim 5, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), wherein the physiological data further comprises heart rate variability data (Stein: [0043] “optical sensors 101 configured to generate photoplethysmography [PPG] signals for measuring heart rate, heart rate variability”). However, the combination of Stein/Kinnunen/Kang/Komada fails to disclose specifically how a decrease in heart rate variability data indicates pregnancy complications.
Moors teaches heart rate variability in hypertensive pregnancy disorders. Moors discloses the method further comprising:
determining that the heart rate variability data is less than a pregnancy baseline heart rate variability for the user for at least the portion of the plurality of days, wherein detecting the indication of the one or more pregnancy complications is based at least in part on determining that the heart rate variability data is less than the pregnancy baseline heart rate variability for the user (Moors pg 63, Section 4.1.1., [1-2] “A lower TP [total power heart rate variation] was found at 12, 24 and 31 weeks of gestation in women who would develop GH [gestational hypertension] later in pregnancy compared to normotensive pregnant controls… Comparing women with PE [preeclampsia] to normotensive pregnant women, TP [total power heart rate variation] showed no difference or a decrease.” Moors pg 64, Section 4.3.1, [2-3] “One study found a decreased HF [high frequency heart rate variation] at 28 weeks of gestation in women who would later develop GH [gestational hypertension] compared to normotensive controls… All three studies comparing HF(n.u.) between PE [preeclampsia] and normotensive controls found a decreased HF [n.u. high frequency normalized] in PE [preeclampsia]”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang/Komada to include how a decrease in heart rate variability data indicates pregnancy complications as disclosed in Moors because HPD (hypertensive pregnancy disorders) are a major cause of maternal and fetal mortality and morbidity worldwide (Moors, pg 56, col 2, [2]).
Regarding claim 6, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), wherein the physiological data further comprises low frequency heart rate variability data (Stein: [0043] “optical sensors 101 configured to generate photoplethysmography [PPG] signals for measuring heart rate, heart rate variability;” [0013] “a low frequency component of a heart rate variability of the female human”). However, the combination of Stein/Kinnunen/Kang/Komada fails to disclose specifically how an increase in low frequency heart rate variability data indicates pregnancy complications.
Moors teaches low frequency heart rate variability in hypertensive pregnancy disorders. Moors discloses the method further comprising:
determining that the low frequency heart rate variability data exceeds a pregnancy baseline low frequency heart rate variability for the user for at least the portion of the plurality of days, wherein detecting the indication of the one or more pregnancy complications is based at least in part on determining that the low frequency heart rate variability data exceeds the pregnancy baseline low frequency heart rate variability for the user (Moors pg 63-4, Section 4.2.1., [1-3] In CH [chronic hypertension], LF [low frequency heart rate variability] was increased or comparable to normotensive controls… LF(n.u.) was increased in women who would develop GH [gestational hypertension] at 12, 24 and 31 weeks of gestation compared to normotensive controls… and an increased LF in PE [preeclampsia]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang/Komada to include how an increase in low frequency heart rate variability data indicates pregnancy complications as disclosed in Moors because HPD (hypertensive pregnancy disorders) are a major cause of maternal and fetal mortality and morbidity worldwide (Moors, pg 56, col 2, [2]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1), and in further view of Silva (DOI: 10.3109/10641950902779271).
Regarding claim 7, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), wherein the physiological data further comprises respiratory rate data, the method further comprising: determining that the respiratory rate data (Stein: Fig. 3; [0043] “optical sensors 101 configured to generate photoplethysmography (PPG) signals for measuring … breathing rate”). However, the combination of Stein/Kinnunen/Kang/Komada fails to disclose respiratory rate data exceeding a baseline indicating pregnancy complications.
Silva (DOI: 10.3109/10641950902779271) teaches evaluating maximal respiratory pressures, pulmonary volumes and capacities and exercise functional capacity in pregnant women with preeclampsia. Silva discloses the respiratory rate data exceeds a pregnancy baseline respiratory rate for the user for at least the portion of the plurality of days, wherein detecting the indication of the one or more pregnancy complications is based at least in part on determining that the respiratory rate data exceeds the pregnancy baseline respiratory rate for the user (Silva, Abstract, [1] “The group with preeclampsia showed higher minute ventilation and lower forced vital capacity and exercise tolerance”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang/Komada to include how an increase in respiratory rate data indicates pregnancy complications as disclosed in Silva because preeclampsia showed significant alterations in the respiratory system (Silva, Abstract).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1), and in further view of Payne (DOI: 10.1016/S1701-2163(15)30358-3).
Regarding claim 8, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”), wherein the physiological data further comprises blood oxygen saturation data ([0043] optical sensors 101 configured to generate photoplethysmography [PPG] signals). However, Stein fails to specifically disclose oxygen saturation data exceeding a baseline correlating with pregnancy complications.
Payne (DOI: 10.1016/S1701-2163(15)30358-3) teaches assessing blood oxygen saturation (SpO2) in a risk prediction model for adverse outcomes among pregnant women with a hypertensive disorder of pregnancy (HDP). Payne discloses the method further comprising:
determining that the blood oxygen saturation data is less than a pregnancy baseline blood oxygen saturation for the user for at least a portion of the plurality of days, wherein detecting the indication of the one or more pregnancy complications is based at least in part on determining that the blood oxygen saturation data is less than the pregnancy baseline blood oxygen saturation for the user (Payne, pg 2, Results section, [1] “SpO2 of<93% was associated with a 30-fold increase in risk of adverse maternal outcome compared to women with SpO2 >97%”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang/Komada to include oxygen saturation data exceeding a baseline correlating with pregnancy complications as disclosed in Payne because SpO2 is a significant independent predictor of risk in pregnant women with a hypertensive disorder of pregnancy (Payne, pg 2, Conclusion [1]).
Claim(s) 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1), and in further view of Pardey (US 20190110692 A1).
Regarding claim 11, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”). However, the combination of Stein/Kinnunen/Kang/Komada fails to disclose estimating a likelihood of future pregnancy complication.
Pardey (US 20190110692 A1) teaches methods and apparatus for analyzing and further processing the data to provide health information in relation to a user's fertility. Pardey discloses, further comprising:
estimating a likelihood of a future pregnancy complication based at least in part on identifying that the plurality of temperature values deviates from than the pregnancy baseline of temperature values (Pardey [0579] “characteristics of the change in basal body temperature may be used to determine levels of hormones such as progesterone. Such characteristics may include an absolute change in the temperature over the plurality of days, [etc.];” [0580] “an increase in progesterone levels in a female human user who is in the very early stages of pregnancy is indicative in some woman of an increased likelihood of miscarriage”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang/Komada to include the likelihood of miscarriage as disclosed in Pardey to monitor the progression of a pregnancy (Pardey [580]).
Regarding claim 18, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”). However, the combination of Stein/Kinnunen/Kang/Komada fails to particularly disclose hypertension, preeclampsia, eclampsia, cardiometabolic disorders, or infection.
Pardey discloses wherein the one or more pregnancy complications comprise preeclampsia, cardiometabolic disorders, or a combination thereof (Pardey: [0082] “Risk of Miscarriage, Risk of Pre-Eclampsia/Diagnosis of Pre-Eclampsia, … Disease Onset/Pyrexia/Early Disease Detection, Heart Attack Risk/Onset of Heart Attack”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang to include detecting pregnancy complications such as miscarriage, pre-eclampsia, disease onset/pyrexia/early disease, heart attack risk/onset of heart attack as disclosed in Pardey to provide information relevant to the fertility of the user and for other fitness and health-related purposes (Pardey [0145]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1) in view of Kinnunen (US 20210007658 A1), Kang (CN 105249937 A), and Kodama (US 20020040194 A1), and in further view of Euliano (US 20210161402 A1).
Regarding claim 12, the combination of Stein/Kinnunen/Kang/Kodama discloses the method of claim 1 (Stein: [0001] “method for detecting events related to a pregnancy of a female human”). However the combination of Stein/Kinnunen/Kang fails to disclose identifying a false positive. Euliano teaches a system and method for diagnosing and classifying preeclampsia-related conditions in a patient. Euliano discloses further comprising: identifying a false positive for detecting the indication of the one or more pregnancy complications based on a physiological measurement or a combination of physiological measurements ([0116] “the preeclampsia diagnosis and classification system 30 can be used to determine whether a patient with high or rising blood pressure has or likely has preeclampsia or simply hypertension… the preeclampsia diagnosis and classification system 30 would be programmed to create a ‘rule-out preeclampsia’ test that has a very low number of false negatives.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Stein/Kinnunen/Kang to include identifying a false positive as disclosed in Euliano to improve prediction accuracy of when a patient will not get preeclampsia (Euliano [0116]).
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791