Office Action 5: Notice of Allowance (2025-03-12)

CLAIMS:
AMENDMENTS TO THE CLAIMS

The following listing of claims will replace all previous versions and listings of claims:

Listing of Claims

1\. (Currently Amended) A fetal monitoring patch for determining a health condition of a fetus based on biosignals of an expecting mother and the fetus, the fetal monitoring patch comprising:\[\[an\]\] a first acoustic sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from an anterior side location on a maternal torso;
an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from an anterior centralized location on the maternal torso relative to the anterior side locatio;
a breathable substrate configured to-provide skin contact of the first acoustic sensor via a first acoustic impedance coupler and skin contact of the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring; and
a microcontroller mechanically coupled with the breathable substrate, wherein the microcontroller is configured for:continuously monitoring fetal movement (fM) using the firstacoustic sensor while operating in a first mode, wherein the first mode is a low-power vigilant monitoring state; and
upon detecting reduced fM activity, transitioning to a second mode comprising:decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data to extract mechano-acoustically sensed fetal phonocardiogram (fPCG) data;

determining fetal heart rate variability (fHRV) data from the mechano- acoustically sensed fPCG data; and providing an alert to the expecting mother based on the fHRV data, wherein the alert is indicative of a medical emergency.
2\. (Canceled)
3\. (Canceled)
4\. (Currently Amended) The fetal monitoring patch of claim 1, wherein the microcontroller is further configured to calculate fetal movement (fM) data from the mechano-acoustically sensed aPCG data.

5\. (Currently Amended) The fetal monitoring patch of claim 1, wherein:the optical sensor is further configured to sense maternal peripheral capillary oxygen saturation (mSpO2) data; and
transitioning to the second mode is further based upon detecting reduced mSpO2 data.
6\. (Canceled)

7\. (Currently Amended) The fetal monitoring patch of claim 1, wherein the microcontroller is further configured to calculate a maternal activity level from the optical sensor.

8\. (Currently Amended) The fetal monitoring patch of claim 1, further comprising one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope.

9\. (Currently Amended) The fetal monitoring patch of claim 1, further comprising a patch configured to removably attach to the maternal torso.

10\. (Canceled)

11\. (Canceled)

12\. (Canceled)

13\. (Currently Amended) The fetal monitoring patch of claim 1, further comprising an inclinometer sensor that detects a sub-audible abdominal acoustic wave.

14\. (Currently Amended) The fetal monitoring patch of claim 1, wherein a first portion of the fetal monitoring patch is disposable, and a second portion of the fetal monitoring patch is re-usable.

15\. (Canceled)

16\. (Currently Amended) The fetal monitoring patch of claim 1 \[\[,\]\] further comprising;a second acoustic sensor configured to provide mechano-acoustically sensed aPCG data from an opposite anterior side location on the maternal torso; and
a noise attenuator configured to: at least partially constructively or destructively combine a first physiological signal component of a first signal output by \[\[a\]\] the first

acoustic sensor and a second physiological signal component of a second signal output by a second acoustic sensor.

17\. (Currently Amended) A method of determining a health condition of a fetus based on biosignals of an expecting mother and the fetus, the method comprising:providing a fetal monitoring patch , comprising:\[\[an\]\] a first acoustic sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from an anterior side location on a maternal torso;
an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from an anterior centralized location on the maternal torso relative to the anterior side location ;
a breathable substrate configured to provide skin contact of the firstacoustic sensor via a first acoustic impedance coupler and skin contact of the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring;
and a microcontroller mechanically coupled with the breathable substrate,
wherein the microcontroller is configured for:continuously monitoring fetal movement (fM) using the firstacoustic sensor while operating in a first mode, wherein the first mode is a low-power vigilant monitoring state; and
upon detecting reduced fM activity, transitioning to a second mode comprising:decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data to extract mechano-acoustically sensed fetal phonocardiogram (fPCG) data;

determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data; and
providing an alert to the expecting mother based on the fHRV data, wherein the alert is indicative of a medical emergency.

18\. (Canceled)

19\. (Previously Presented) The method of claim 17, further comprising outputting at least one of a normal state, caution state, and emergency state based on the mechano-acoustically sensed fPCG data.

20\. (Previously Presented) The method of claim 17, further comprising calculating fetal movement (fM) data from the mechano-acoustically sensed aPCG data.

21\. (Currently Amended) A non-transitory computer-readable storage medium, the non- transitory computer-readable storage medium storing instructions to be implemented on a fetal monitoring patch comprising:\[\[an\]\] a first acoustic sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from an anterior side location on a maternal torso;
an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from an anterior centralized location on the maternal torso relative to the anterior side locatio;a breathable substrate configured to provide skin contact of the first acoustic sensor via a first acoustic impedance coupler and skin contact of the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring; and
at least one processor mechanically coupled with the breathable substrate;
the instructions when executed by the at least one processor cause the fetal monitoring patch to perform a method of determining a health

\[\[heath\]\] condition of a fetus based on biosignals of an expecting mother and the fetus, the method comprising:
continuously monitoring fetal movement (fM) using the acoustic sensor while operating in a first mode, wherein the first mode is a low-power vigilant monitoring state; and
upon detecting reduced fM activity, transitioning to a second mode comprising:decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data to extract mechano-acoustically sensed fetal phonocardiogram (fPCG) data;
determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data; and providing an alert to the expecting mother based on the fHRV data, wherein the alert is indicative of a medical emergency.

22\. (Canceled)

23\. (Currently Amended) The fetal monitoring patch of claim 1, wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using empirical mode decomposition (EMD).

24\. (Canceled)

25\. (Canceled)

26\. (New) The fetal monitoring patch of claim 1, wherein the anterior centralized location is lower on the maternal torso than the anterior side location on the maternal torso.

27\. (New) The fetal monitoring patch of claim 16, wherein the anterior centralized location is lower on the maternal torso than both the anterior side location and the opposite anterior side location.

28\. (New) The fetal monitoring patch of claim 27, wherein the anterior centralized location is closer to the anterior side location than to the opposite anterior side location.

29\. (New) The fetal monitor patch of claim 1, wherein the fetal monitoring patch is configured as a singular unit in a form of a wearable pressure adhesive patch.

OFFICE ACTION:
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 .
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
The scope of a fetal health monitoring device configured to use the first acoustic sensor while operating in a first mode, and upon detecting reduced fetal movement activity, transitioning to a second mode was not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is Queyam (NPL “An IoT Based Multi-Parameter Data Acquisition System for Efficient Bio-Telemonitoring of Pregnant Women at Home” published in 2018); however it fails to recite these features.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

APPLICANT REBUTTAL: REMARKS
Applicant has carefully reviewed the non-final Office Action mailed on December 2, 2024, and offers the following remarks to accompany the above amendments. Further, the Applicant would like to request an Examiner interview to discuss any unresolved issues.
Examiner Interview
Applicant wishes to thank Examiner Hodge and Primary Examiner Jian for the telephonic interview conducted on December 23, 2024. Examiner Hodge indicated that specifying the placement of the sensors should advance the prosecution under the currently pending 35 U.S.C. 101 rejection.
Summary of Remarks
Applicant has amended independent claims 1, 17, and 21 to indicate approximate anterior positions of a first acoustic sensor and an optical sensor relative to a maternal torso.
Status of the Claims
Claims 1, 4-5, 7-9, 11, 13-14, 17, 19-21, 23, and 25 were previously pending. Claims 2-3, 6, 10, 12, 15, 18, 22, and 24 were previously canceled. Claims 1, 4-5, 7-9, 13-14, 16- 17, 19-21, and 23 are amended herein. Claims 11 and 25 are canceled herein. New claims 26-29 are added herein. As such, claims 1, 4-5, 7-9, 11, 13-14, 17, 19-21, 23, and 26-29 remain pending.
Objection to the Claims
Claim 21 is objected to due to a spelling error. The cited limitation of claim 21 has been amended as follows:
Docket No.: 908/17 UTIL
Application No.: 17/336,547
the instructions when executed by the at least one processor cause
the fetal monitorin
g
patch
w
earable fetal health monitoring device
to perform a method of determining a
health
[[heath]] condition of a fetus based on biosignals of an expecting mother and the fetus, the method
comprising:
Accordingly, it is respectfully submitted that the objection to claim 21 be withdrawn.
Claim Rejections Under 35 U.S.C. 101
Claims 1, 4-5, 7-9, 11, 13-14, 16-17, 19-21, 23, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Claim 1 has been amended to recite:
(Currently Amended) A
fetal monitorin
g
patch
wearable fetal health monitoring device
for determining a health condition of a fetus based on biosignals of an expecting mother and the fetus, the
fetal monitorin
g
patch
wearable fetal health monitoring device
comprising:
[[an]]
a
fi
rst
acoustic sensor configured to provide mechano- acoustically sensed phonocardiogram (aPCG) data from
afirst
an anterior
side
location on a maternal torso;
an optical sensor configured to provide optically sensed maternal
photoplethysmogram (mPPG) data from
a second
an anterior centralized
location on the maternal torso
relative to the anterior
side location
,
wherein
the first location and the second location are mutually exclusive
;
a
breathable substrate
securing device
configured toprovide skin
contact of the
frs
t
acoustic sensor
via a first acoustic impedance coupler
908/17 UTIL
and
skin contact o
f
the optical sensor to the maternal torso for continuous
non-invasive non-clinical monitoring; and
a microcontroller
mechanically coupled with the breathable substrate,
wherein the microcontroller is
configured for:
continuous
ly
monitoring fetal movement (fM) using the
frs
t
acoustic sensor
while operating in a first mode, wherein the first mode is a low-power
vigilant monitoring state; and
upon detecting reducedfM activity, transitioning to a second mode comprising: decomposing the mechano-acoustically sensed aPCG data using the optically
sensed mPPG    data to extract mechano-acoustically sensed fetal
phonocardiogram (fPCG) data;
determining fetal heart rate variability (fHRV) data from the mechano- acoustically sensed fPCG data; and
providing an alert to the expecting mother based on the fHR V data, wherein the
alert is indicative of a medical emergency.
Support for the above amendment may be found in at least the following paragraphs and figures of the Published Application:
FIGS. 1 through 6 illustrate various aspects of the presently
disclosed subject matter. FIG. IA is a block diagram of various physical hardware in a wearable fetal monitoring device, according to at least one embodiment of the presently disclosed subject matter. FIG. 1B is a perspective view illustrating the placement of the belt-based version of the device and the adhesive patch version of the device, according to at least one embodiment of the presently disclosed subject matter. FIG. 2 is a flowchart of the operational cycle of a fetal monitoring device, according to at least one embodiment of the presently disclosed subject matter. FIG.
Docket No.: 908/17 UTIL
Application No.: 17/336,547
3A is a top-down view of the non-contact side of a fetal monitoring patch, according to at least one embodiment of the presently disclosed subject matter. FIG. 3B is a profile view of the internal components of a fetal monitoring patch, according to at least one embodiment of the presently disclosed subject matter. FIG. 3C is a bottom view of the skin contacting side of a fetal monitoring patch, according to at least one embodiment of the presently disclosed subject matter. FIG. 3D is a top-down view of the two hardware modules of a fetal monitoring band, according to at least one embodiment of the presently disclosed subject matter. FIG. 5 is a flowchart of the flow of data in a fetal monitoring device, according to at least one embodiment of the presently disclosed subject matter. FIG. 6 is a flowchart of a vigilant monitor decision stream, according to at least one embodiment
of the presently disclosed subject matter.
FIG. 1B
908/17 UTIL
FIG. 3A
FIG. 3B
Docket No.: 908/17 UTIL
Application No.: 17/336,547
device forming part of system 100 is configured as a singular unit in the form of a wvearable pressure adhesive patch in the form of patch 110, as
shown on the right-side illustration of FIG. lB.
[0051] A simplified component layout of a wearable fetal
monitoring device in the form of a wearable pressure adhesive patch 110 (alternately referred to herein as "patch 110" or "patch') is shown in FIGS. 3A, SB and C. FIG. 3A illustrates a nondermal distal side ofpatch 110 with primaly components visible. In one embodiment, components of
908/17 UTIL
patch 110 are placed on a flexible board and connected with one or more flexible interconnects 309. The components of patch 110 can comprise a microcontroller 301. In one embodiment, microcontroller 301 can comprise one of one or multiple cores capable of ultralow power sleep states. The components of patch 110 can further comprise a wireless communication module 302. In one embodiment, wireless communication module 302 can comprise one or more of the following sub-components: chip antenna, rigid-island antenna, flexible antenna, and similar other sub-components.
The components of patch 110 cab furthermore comprise a memory data storage 303. In one embodiment, memory data storage 303 can comprise a non-volatile memory data storage such as, for example, a Quad-SPI non- volatile memory data storage. The components of patch 110 can additionally comprise power management circuit 304 and a power source 305. In one embodiment, patch 110 includes a breathable substrate 310.
In one embodiment, a biocompatible material engineered to match the acoustic impedance of soft tissue is shown in the dermal contact side of patch 110. In one embodiment, patch 110 further includes an acoustic impedance coupler 308. In one embodiment, acoustic impedance coupler 308 is the primary point ofskin contactfor acoustic sensors 306 to minimize reflected signal loss due to acoustic impedance mismatch between the fetal health monitoring device and soft tissue. Since fetal signal is generally low magnitude, maximizing signal transmission to transducer is key for accurate feature extraction. The material in acoustic impedance coupler 308 can be composed of polydimethylsiloxane adjusted with TiO2 nanoparticles. In another embodiment, material of acoustic impedance coupler 308 can be composed of modified polyurethane or other
nanocomposites.
Docket No.: 908/17 UTIL
Application No.: 17/336,547
Amended claim 1 is directed toward a specific structure (i.e. afetal monitoring patch) including a specific materal (i.e. a breathable substrate) and approximate anterior positions of afirst acoustic sensor and an optical sensor relative to a maternal torso. Clearly the fetal monitor patch of amended claim 1 is much more than an abstract idea. As such amended claim 1 is allowable.
Claims 4-5, 7-9, 13-14, 16, and 23 depend directly from amended claim 1 and are allowable at least by virtue of their dependence from amended claim 1.
Claims 17 and 21 have been amended to include features similar to now allowable claim 1. As such claims 17 and 21 are also allowable.
Claims 19-20 depend directly from amended claim 17 and are allowable at least by virtue of their dependence from amended claim 17.
Claims 11 and 25 have been canceled rendering their rejection moot.
Accordingly, it is respectfully submitted that the rejection under 35 U.S.C. 101 of claims 1, 4-5, 7-9, 13-14, 17, 19-21, and 23 be withdrawn.
New Claims
Support for new claims 26-28 may be found in at least the following paragraphs and figures of the Published Application:
[0044] FIGS. 1 through 6 illustrate various aspects of the presently
disclosed subject matter. FIG. IA is a block diagram of various physical hardware in a wearable fetal monitoring device, according to at least one embodiment of the presently disclosed subject matter. FIG. 1B is a perspective view illustrating the placement of the belt-based version of the device and the adhesive patch version of the device, according to at least
908/17 UTIL
one embodiment of the presently disclosed subject matter. FIG. 2 is a flowchart of the operational cycle of a fetal monitoring device, according to at least one embodiment of the presently disclosed subject matter. FIG.
3A is a top-down view of the non-contact side of a fetal monitoring patch, according to at least one embodiment of the presently disclosed subject matter. FIG. 3B is a profile view of the internal components of a fetal monitoring patch, according to at least one embodiment of the presently disclosed subject matter. FIG. 3C is a bottom view of the skin contacting side of a fetal monitoring patch, according to at least one embodiment of the presently disclosed subject matter. FIG. 3D is a top-down view of the two hardware modules of a fetal monitoring band, according to at least one embodiment of the presently disclosed subject matter. FIG. 5 is a flowchart of the flow of data in a fetal monitoring device, according to at least one embodiment of the presently disclosed subject matter. FIG. 6 is a flowchart of a vigilant monitor decision stream, according to at least one embodiment
of the presently disclosed subject matter.
UT
FIG. 3A
FIG. 3B
Docket No.: 908/17 UTIL
Application No.: 17/336,547
FIG. 3C
Support for new claim 29 may be found in at least the following paragraph of the Published Application:
[0045] ... In various embodiments, belt 108 may comprise a
breathable elastomeric or fabric material. In some embodiments, the device forming part of system 100 is configured as a singular unit in the form of a wearable pressure adhesive patch in the form of patch 110, as
shown on the right-side illustration of FIG. lB.
New claims 26-29 depend, either directly or indirectly, from now allowable independent claim 1. Accordingly, it is respectfully submitted that new claims 26-29 are allowable.
908/17 UTIL
CONCLUSION