DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/25/2025 has been entered.
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-15, 17-20 are pending.
This action is Non-Final.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7-9, 11-15, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Graf et al. (Graf, US 2015/0119749) in view of Park et al. (Park, US 2016/0259905) and Johnson et al. (Johnson, US 2011/0201911).
Regarding claim 1, Graf teaches a method comprising:
acquiring physiological data associated with the user, including temperature of a user that is pregnant, from a temperature device (see at least Figure 4, [0038]);
receiving, via a transceiver of a user device and from the temperature device, the physiological data associated with the user, the physiological data comprising at least temperature data (see at least Figure 4, [0013], [0036], [0038]);
determining, via one or more processors of the user device, a time series of a plurality of temperature values taken over a plurality of days based at least in part on the received temperature data (see at least Figure 6, [0040]);
identifying, via the one or more processors of the user device, temperature elevations in the time series of the plurality of temperature values relative to a temperature baseline for the user based at least in part on determining the time series, the time series comprising temperature values corresponding to a plurality of menstrual cycles of the user (see at least Figure 6, [0043], [0048], [0050]);
detecting, via the one or more processors of the user device, an indication of a pregnancy of the user based at least in part on the temperature elevations, wherein the indication of the pregnancy of the user is prior to an absence of a subsequent menstrual cycle of the user (see at least [0009] interpreted as fertility status and temperature chart, which increase in temperature occurs prior to missed periods); and
causing, via the one or more processors of the user device, a graphical user interface of the user device to display the indication of the pregnancy (see at least Figure 6, [0013]).
However, the limitations the temperature device is one or more temperature sensors of a wearable ring configured to be worn on a finger of a user, and adjusting, via the one or more processors of the user device, an operational mode in response to detection of the indication of the pregnancy, wherein subsequent physiological data is analyzed in accordance with the adjusted operational mode are not directly taught
Park teaches a related system for monitoring physiological data and includes monitoring temperature and menstrual cycles for determination of pregnancy by comparing current trends to reference database data (see at least abstract, Figure 35, [0303], [0327]-[0328]), and teaches alternative wearable devices including ring type and wrist worn devices, which reasonably teaches the features the temperature device is one or more temperature sensors of a wearable ring device configured to be worn on a finger of a user (see at least [0082], [0198]). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine prior art elements according to known methods to compare data to database reference data for better indication of health data, and as an obvious substitution of one temperature device for another to obtain predictable results of gathering physiological data by sensors on the device in order to monitor physiological health of a user.
Johnson teaches a related system for receiving and analyzing physiological data of a user (see at least title and abstract), and teaches that a user can adjust operation mode of the device such that after a first mode like custom or diagnostic mode with an indication of pregnancy then a pregnancy mode can be selected and operated following the protocol of such mode which reasonably teaches the limitations adjusting, via the one or more processors of the user device, an operational mode in response to detection of the indication of the pregnancy, wherein subsequent physiological data is analyzed in accordance with the adjusted operational mode (see at least Figure 9, [0083]-[0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of operating a monitoring device in changeable modes in order to allocate resources to current conditions when such conditions are indicated in order to perform the necessary monitoring of such conditions.
Regarding claim 2, the limitations are met by Graf in view of Park and Johnson, where Graf teaches identifying one or more local maximum of a first portion of the time series of the plurality of temperature values based at least in part on determining the time series (see at least Figure 6); and identifying one or more local maximum of a second portion following the first portion of the time series of the plurality of temperature values based at least in part on determining the time series, wherein identifying the temperature elevations in the time series is based at least in part on identifying the one or more local maximum of the first portion and the second portion (see at least Figure 6).
Regarding claim 3, the limitations are met by Graf in view of Park and Johnson, where the combination teaches comparing the one or more local maximum of the first portion and the one or more local maximum of the second portion, wherein the first portion corresponds to the plurality of menstrual cycles for the user and the second portion corresponds to a time period corresponding to the pregnancy (see Figure 6 of Graf, and Park Figure 35, [0327]-[0328]); and determining that the one or more local maximum of the second portion are greater than the one or more local maximum of the first portion based at least in part on the comparison comparing the one or more local maximum of the first portion and the one or more local maximum of the second portion, wherein detecting the pregnancy is based at least in part on the determination (see Figure 6 of Graf, and Park Figure 35, [0327]-[0328]). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine prior art elements according to known methods to compare data to database reference data for better indication of health data.
Regarding claim 7, the limitations are met by Graf in view of Park and Johnson, where the combination teaches identifying a cessation of cyclicity of the plurality of menstrual cycles of the user based at least in part on determining the time series, wherein detecting the pregnancy is based at least in part on identifying the cessation of cyclicity (see Graf Figure 6, and Park Figure 35, where the cycle of pregnant verse non-pregnant is identified). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine prior art elements according to known methods to compare data to database reference data for better indication of health data.
Regarding claim 8, the limitations are met by Graf in view of Park and Johnson, where the combination teaches identifying the absence of the subsequent menstrual cycle based at least in part on determining the time series (see Graf Figure 6, and Park Figure 35, where the cycle of pregnant verse non-pregnant is identified). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine prior art elements according to known methods to compare data to database reference data for better indication of health data.
Regarding claim 9, the limitations are met by Graf in view of Park and Johnson, where Graf teaches receiving, via the user device and in response to detecting the indication of the pregnancy, a confirmation of the pregnancy, wherein detecting the indication of the pregnancy occurs prior to a confirmation of the pregnancy (see at least [0012], [0039] claim 17 secondary info including pregnancy test).
Regarding claim 11, the limitations are met by Graf in view of Park and Johnson, where Graf teaches validating the indication of the pregnancy based at least in part on a physiological measurement or a combination of physiological measurements (see at least [0012], [0039] claim 17 secondary info including pregnancy test).
Regarding claim 12, the limitations are met by Graf in view of Park and Johnson, where Graf teaches causing the graphical user interface of the user device associated with the user to display pregnancy symptom tags based at least in part on detecting the indication of the pregnancy (see at least [0012], [0039] claim 17 secondary info including breast tenderness/fullness).
Regarding claim 13, the limitations are met by Graf in view of Park and Johnson, where Graf teaches causing the graphical user interface of the user device associated with the user to display a message associated with the indication of the pregnancy (see at least [0012], [0039] claim 17 secondary info including breast tenderness/fullness).
Regarding claim 14, the limitations are met by Graf in view of Park and Johnson, where Graf teaches wherein the message further comprises a time interval during which detecting the indication of pregnancy occurred, a request to input symptoms associated with the pregnancy, educational content associated with the pregnancy, an adjusted set of activity targets, or a combination thereof (see at least [0012], [0039] claim 17 secondary info including breast tenderness/fullness).
Regarding claim 15, the limitations are met by Graf in view of Park and Johnson, where Graf teaches identifying a false positive for detecting the indication of the pregnancy based at least in part on a physiological measurement or a combination of physiological measurements. (see at least [0012], [0039] claim 17 secondary info including pregnancy test, i.e. negative result).
Regarding claim 17, the limitations are met by Graf in view of Park and Johnson, where Park teaches wherein the wearable ring device collects additional physiological data from the user based on arterial blood flow (see at least [0122], [0164] heart rate monitor, blood pressure).
Regarding claim 18, Graf teaches a system, comprising:
a device configured to measure photoplethysmogram (PPG) data, temperature data, or both from the user (see at least Figure 4, [0038]);
a user device communicatively coupled with the device (see at least Figure 1); and
one or more processors communicatively coupled with the device and the user device (see at least Figures 1, 6, [0009]), the one or more processors configured to;
acquire, via one or more temperature sensors of the device, physiological data associated with the user (see at least Figure 4, [0038]);
receive, via a transceiver of the user device and from the device, the physiological data associated with the user, the physiological data comprising at least the temperature data (see at least Figure 4, [0013], [0036], [0038]);
determine, via the one or more processors, a time series of a plurality of temperature values taken over a plurality of days based at least in part on the received temperature data (see at least Figure 6, [0040]);
identify, via the one or more processors, temperature elevations in the time series of the plurality of temperature values relative to a temperature baseline for the user based at least in part on determining the time series, the time series comprising temperature values corresponding to a plurality of menstrual cycles of the user (see at least Figure 6, [0043], [0048], [0050]);
detect, via the one or more processors, an indication of a pregnancy of the user based at least in part on the temperature elevations, wherein the indication of the pregnancy of the user is prior to an absence of a subsequent menstrual cycle of the user (see at least [0009] interpreted as fertility status and temperature chart, which increase in temperature occurs prior to missed periods); and
cause, via the one or more processors, a graphical user interface of the user device to display the detected indication of the pregnancy (see at least Figure 6, [0013]).
However, the limitations that the device is a wearable ring device configured to be worn by a user and measure photoplethysmogram (PPG) data, temperature data, or both from the user, adjust, via the one or more processors, an operational mode in response to detection of the indication of the pregnancy, wherein subsequent physiological data is analyzed in accordance with the adjusted operational mode are not directly taught.
Park teaches a related system for monitoring physiological data and includes monitoring temperature and menstrual cycles for determination of pregnancy by comparing current trends to reference database data (see at least abstract, Figure 35, [0303], [0327]-[0328]), and teaches alternative wearable devices including ring type and wrist worn devices, which reasonably teaches the features the device is a wearable ring device configured to be worn by a user and measure photoplethysmogram (PPG) data, temperature data, or both from the user (see at least [0082], [0198]). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine prior art elements according to known methods to compare data to database reference data for better indication of health data, and as an obvious substitution of one temperature device for another to obtain predictable results of gathering physiological data by sensors on the device in order to monitor physiological health of a user.
Johnson teaches a related system for receiving and analyzing physiological data of a user (see at least title and abstract), and teaches that a user can adjust operation mode of the device such that after a first mode like custom or diagnostic mode with an indication of pregnancy then a pregnancy mode can be selected and operated following the protocol of such mode which reasonably teaches the limitations adjust, via the one or more processors, an operational mode in response to detection of the indication of the pregnancy, wherein subsequent physiological data is analyzed in accordance with the adjusted operational mode (see at least Figure 9, [0083]-[0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of operating a monitoring device in changeable modes in order to allocate resources to current conditions when such conditions are indicated in order to perform the necessary monitoring of such conditions.
Regarding claim 19, the limitations are met by Graf in view of Park and Johnson, where Graf teaches wherein the one or more processors are further configured to: identify one or more local maximum of a first portion of the time series of the plurality of temperature values based at least in part on determining the time series (see at least Figure 6); and
identify one or more local maximum of a second portion following the first portion of the time series of the plurality of temperature values based at least in part on determining the time series, wherein identifying the temperature elevations in the time series is based at least in part on identifying the one or more local maximum of the first portion and the second portion (see at least Figure 6).
Regarding claim 20, Graf teaches a non-transitory computer-readable medium storing code (see at least [0009]), the code comprising instructions executable by a processor to:
acquire, via one or more temperature sensors of a device, by a user that is pregnant, physiological data associated with the user (see at least Figure 4, [0038]);
receive, via a transceiver of a user device and from the device, the physiological data associated with the user, the physiological data comprising at least temperature data (see at least Figure 4, [0013], [0036], [0038]);
determine, via one or more processors of the user device, a time series of a plurality of temperature values taken over a plurality of days based at least in part on the received temperature data (see at least Figure 6, [0040]);
identify, via the one or more processors of the user device, temperature elevations in the time series of the plurality of temperature values relative to a temperature baseline for the user based at least in part on determining the time series, the time series comprising temperature values corresponding to a plurality of menstrual cycles of the user (see at least Figure 6, [0043], [0048], [0050]);
detect, via the one or more processors of the user device, an indication of a pregnancy of the user based at least in part on the temperature elevations, wherein the indication of the pregnancy of the user is prior to an absence of a subsequent menstrual cycle of the user (see at least [0009] interpreted as fertility status and temperature chart, which increase in temperature occurs prior to missed periods); and
cause, via the one or more processors of the user device, a graphical user interface of the user device to display the indication of the pregnancy (see at least Figure 6, [0013]).
However, the limitations that the device is a wearable ring device configured to be worn on a finger of a user, and adjust, via the one or more processors of the user device, an operational mode in response to detection of the indication of the pregnancy, wherein subsequent physiological data is analyzed in accordance with the adjusted operational mode are not directly taught.
Park teaches a related system for monitoring physiological data and includes monitoring temperature and menstrual cycles for determination of pregnancy by comparing current trends to reference database data (see at least abstract, Figure 35, [0303], [0327]-[0328]), and teaches alternative wearable devices including ring type and wrist worn devices, which reasonably teaches the features the device is a wearable ring device configured to be worn on a finger of a user (see at least [0082], [0198]). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to combine prior art elements according to known methods to compare data to database reference data for better indication of health data, and as an obvious substitution of one temperature device for another to obtain predictable results of gathering physiological data by sensors on the device in order to monitor physiological health of a user.
Johnson teaches a related system for receiving and analyzing physiological data of a user (see at least title and abstract), and teaches that a user can adjust operation mode of the device such that after a first mode like custom or diagnostic mode with an indication of pregnancy then a pregnancy mode can be selected and operated following the protocol of such mode which reasonably teaches the limitations adjust, via the one or more processors of the user device, an operational mode in response to detection of the indication of the pregnancy, wherein subsequent physiological data is analyzed in accordance with the adjusted operational mode (see at least Figure 9, [0083]-[0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of operating a monitoring device in changeable modes in order to allocate resources to current conditions when such conditions are indicated in order to perform the necessary monitoring of such conditions.
Claims 4-5, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Graf et al. (Graf, US 2015/0119749) in view of Park et al. (Park, US 2016/0259905) and Johnson et al. (Johnson, US 2011/0201911) as applied to claim 1 above, and further in view of Tholen et al. (Tholen, US 2018/0035982).
Regarding claim 4, the limitations are met by Graf in view of Park and Johnson, as taught above, where Park additionally teaches wherein the physiological data further comprises heart rate data (see at least [0010], [0313]), the method further comprising:
acquiring the heart rate data via one or more light-emitting components and one or more light-receiving components of the wearable ring device (see at least [0238] it is well known that PPG can be acquired via these sensors and heart rate derived from such and incorporated into a ring such as Fig. 6B 650, where HRM appears to amount to a PPG as table 3 heart rate, oxygen saturation, respiration rate, blood pressure are known to be measured through use of such sensor);
however, the limitations of determining that the heart rate data exceeds a non-pregnancy baseline heart rate for the user for at least a portion of the plurality of days, wherein detecting the indication of the pregnancy is based at least in part on determining that the received heart rate data exceeds the non-pregnancy baseline heart rate for the user are not directly taught.
Tholen teaches a related system for monitoring the fertility phases of a user (see title, and includes monitoring temperatures and other parameters including heart rate (see at least Figures 3-6 ), including determining that the heart rate data exceeds a non-pregnancy baseline heart rate for the user for at least a portion of the plurality of days, wherein detecting the indication of the pregnancy is based at least in part on determining that the received heart rate data exceeds the non-pregnancy baseline heart rate for the user (see at least Figures 2-5, [0016], [0017], [0054], [0060], [0061], [0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of determining multiple physiological signal type changes from threshold values in order to monitor the cyclicity and the end of cyclicity of data related to a user’s menstrual cycle in order to identify phases and changes.
Regarding claim 5, the limitations are met by Graf in view of Park and Johnson, as taught above, where Park additionally teaches wherein the physiological data further comprises heart rate variability data (see at least [0010], [0313]), the method further comprising:
acquiring the heart rate variability data via one or more light-emitting components and one or more light-receiving components of the wearable ring device (see at least [0238] it is well known that PPG can be acquired via these sensors and heart rate variability derived from such and incorporated into a ring such as Fig. 6B 650, where HRM appears to amount to a PPG as table 3 heart rate, oxygen saturation, respiration rate, blood pressure are known to be measured through use of such sensor);
however, the limitations of determining that the heart rate variability data is less than a non-pregnancy baseline heart rate variability for the user for at least a portion of the plurality of days, wherein detecting the indication of the pregnancy is based at least in part on determining that the heart rate variability data is less than the non-pregnancy baseline heart rate variability for the user is not directly taught.
Tholen teaches a related system for monitoring the fertility phases of a user (see title, and includes monitoring temperatures and other parameters including heart rate (see at least Figures 3-6 ), including determining that the heart rate variability data is less than a non-pregnancy baseline heart rate variability for the user for at least a portion of the plurality of days, wherein detecting the indication of the pregnancy is based at least in part on determining that the heart rate variability data is less than the non-pregnancy baseline heart rate variability for the user (see at least Figures 2-5, [0016], [0017], [0054], [0060], [0061], [0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of determining multiple physiological signal type changes from threshold values in order to monitor the cyclicity and the end of cyclicity of data related to a user’s menstrual cycle in order to identify phases and changes.
Regarding claim 10, the limitations are met by Graf in view of Park and Johnson, except the limitations of determining each temperature value of the plurality of temperature values based at least in part on receiving the physiological data, wherein the temperature data comprises continuous nighttime temperature data is not directly taught.
Tholen teaches a related system for monitoring the fertility phases of a user (see title, and includes monitoring temperatures and other parameters including heart rate (see at least Figures 3-6 ), including determining each temperature value of the plurality of temperature values based at least in part on receiving the physiological data, wherein the temperature data comprises continuous nighttime temperature data (see at least [0052], [0069] “Preferably, the measurements of the heart rate, heart rate variability, perfusion, acceleration, temperature, and galvanic skin response of the female user are performed concurrently. The measurements are performed periodically, e.g. once or more every second.” Once or more a second is interpreted as continuous, which is supported in light of the instant disclosure “In some implementations, the ring 104 may continuously acquire distal temperature (e.g., at a sampling rate).” “In some implementations, the processing module 230-a may sample the user's temperature continuously throughout the day and night. Sampling at a sufficient rate (e.g., one sample per second, one sample per minute, and the like) throughout the day may provide sufficient temperature data for analysis described herein.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using continuous data during nighttime to get an accurate account for temperature changes due to fertility causation as opposed to physiological changes present from daytime activities in order to more accurately determine fertility and pregnancy indicators.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Graf et al. (Graf, US 2015/0119749) in view of Park et al. (Park, US 2016/0259905) and Johnson et al. (Johnson, US 2011/0201911) as applied to claim 1 above, and further in view of Auphan et al. (Auphan, US 2016/0015315).
Regarding claim 6, the limitations are met by Graf in view of Park and Johnson, where Park teaches wherein the physiological data further comprises respiratory rate data, the method further comprising: acquiring the respiratory rate data via one or more light-emitting components and one or more light-receiving components of the wearable ring device (see at least [0346], Fig. 6B 650, where HRM appears to amount to a PPG as table 3 heart rate, oxygen saturation, respiration rate, blood pressure are known to be measured through use of such sensor);
except the limitations of determining that the respiratory rate data exceeds a non-pregnancy baseline respiratory rate for the user for at least a portion of the plurality of days, wherein detecting the indication of the pregnancy is based at least in part on determining that the respiratory rate data exceeds the non-pregnancy baseline respiratory rate for the user are not directly taught
Auphan teaches a related system which analyses user sleep cycle information in concert with menstrual cycle (see at least [0021]), and teaches monitoring different parameters including respiration rate in assessment of sleep during menstrual phases, which in combination with the teachings of Graf in view of Park and Johnson, as discussed prior, reasonably teaches the claimed features wherein the physiological data further comprises respiratory rate data, determining that the respiratory rate data exceeds a non-pregnancy baseline respiratory rate for the user for at least a portion of the plurality of days, wherein detecting the indication of the pregnancy is based at least in part on determining that the respiratory rate data exceeds the non-pregnancy baseline respiratory rate for the user (see at least [0021], respiration rate greater than 0 is above threshold for breathing rate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of analyzing respiration rates in concert with other parameters in order to determine if a user is in particular sleep cycles in order to allow for menstrual cycle monitoring during desired phases.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims and drawings filed 8/25/2025; and IDS filed 10/9/2025, 11/21/2025, 1/23/2026, 3/25/2026, 5/7/2026, 7/30/2026, 9/16/2026.
Applicant’s arguments regarding the drawing/specification objections have been fully considered and are persuasive due to the amendments to the drawings; the objections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(b) have been fully considered and are persuasive due to the amendments to the claims; the rejections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered and are persuasive due to the amendments to the claims and corresponding arguments; the rejections are withdrawn.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive in view of the new grounds of rejections necessitated by the amendments to the claims. The rejections are updated to account for the amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
