Office Action 4: Final Rejection (2024-12-02)
Rejection types: 101 - Patent-Eligible Subject Matter

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 wearable fetal health monitoring device for determining a health condition of a fetus based on biosignals of an expecting mother and the fetus, the wearable fetal health monitoring device comprising: an acoustic sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from a first location on a maternal torso;
an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso, wherein the first location and the second location are mutually exclusive;
a securing device configured to provide skin contact of the acoustic sensor and the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring; and
a microcontroller configured for:
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.

2\. (Canceled)

3\. (Canceled)

4\. (Previously Presented) The wearable fetal health monitoring device of claim 1, wherein the microcontroller is further configured to calculate fetal movement (fM) data from the mechano-acoustically sensed aPCG data.

5\. (Previously Presented) The wearable fetal health monitoring device 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\. (Previously Presented) The wearable fetal health monitoring device of claim 1, wherein the microcontroller is further configured to calculate a maternal activity level from the optical sensor.

8\. (Previously Presented) The wearable fetal health monitoring device of claim 1, further comprising one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope.

9\. (Previously Presented) The wearable fetal health monitoring device of claim 1, further comprising a patch configured to removably attach to the maternal torso.

10\. (Canceled)

11\. (Currently Amended) The wearable fetal health monitoring device of claim 1, wherein the wearable fetal health monitoring device further comprises an acoustic impedance matching housing.

12\. (Canceled)

13\. (Previously Presented) The wearable fetal health monitoring device of claim 1, further comprising an inclinometer sensor that detects a sub-audible abdominal acoustic wave.

14\. (Previously Presented) The wearable fetal health monitoring device of claim 1, wherein a first portion of the wearable fetal health monitoring device is disposable, and a second portion of the wearable fetal health monitoring device is re-usable.

15\. (Canceled)

16\. (Previously Presented) The wearable fetal health monitoring device of claim 1, further comprising a noise attenuator configured to: at least partially constructively or destructively combine a first physiological signal component of a first signal output by a 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 \[\[heath\]\] condition of a fetus based on biosignals of an expecting mother and the fetus, the method comprising:providing a wearable fetal health monitoring device, comprising:
 an acoustic sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from a first location on a maternal torso;

an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso,
wherein the first location and the second location are mutually exclusive;a securing device configured to provide skin contact of the acoustic sensor and the optical sensor to the maternal torso for continuous non-invasive non- clinical monitoring;
and a microcontroller configured for:
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.

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 wearable fetal health monitoring device comprising: an acoustic sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from a first location on a maternal torso;
an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso, wherein the first location and the second location are mutually exclusive;a securing device configured to provide skin contact of the acoustic sensor and the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring; and
at least one processor;
the instructions when executed by the at least one processor cause wearable fetal health monitoring device to perform a method of determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus, the method comprising: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

Dated: June 25, 2024 providing an alert to the expecting mother based on the fHRV data, wherein the alert is indicative of a medical emergency.

22\. (Canceled)

23\. (Previously Presented) The wearable fetal health monitoring device of claim 1, wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using empirical mode decomposition (EMD).

24\. (Canceled)

25\. (Previously Presented) The wearable fetal health monitoring device of claim 1, wherein the securing device is selected from the group consisting of a belt, a band, and an 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 .
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 8/13/24 has been entered.
Status of Claims
Claims 1, 4-5, 7-9, 11, 13-14, 16-17, 19-21, 23, and 25 are rejected. Claims 2-3, 6, 10, 12, 15, 18, 22 and 24 are canceled.
Response to Arguments
Specification Objections
The previous specification objections have been withdrawn.
Claim Objection
The previous claim objection has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
The previous 112 rejection has been withdrawn in view of the claim being canceled.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 6/25/24 have been fully considered but they are not persuasive.
Applicant argues that claim 1 recites additional limitations that reflect an improvement of a technical field (e.g., determining a health condition of a fetus based on biosignals of an expecting mother and the fetus). However, the Examiner disagrees. Providing an alert to the expecting mother of a medical emergency would not be sufficient to overcome the rejection. Providing an alert would still fall under an abstract idea. An improvement to the abstract idea is still an abstract idea.
Applicant argues that an expectant mother would not be capable of continuously monitoring for reduced fetal movement and then determine fHRV from a printout of fPCG data during home monitoring with a fetal electrocardiography (fECG) device. However, the Examiner disagrees. The breadth of the claims is broad. The claims don't specify how often this occurs and how much data is being used. Additionally, applying the abstract idea to a computer does not make the abstract idea eligible under 101.
Applicant argues that the additional elements are not well-understood, routine, or conventional in nature. However, the Examiner disagrees. Under Step 2B of the 101 rejection, the Examiner recited the additional elements of a passive sensor, an optical sensor, a securing device, decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data, and extracting mechano-acoustically sensed fetal phonocardiogram (fPCG) data amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the passive sensor, optical sensor, securing device, decomposing step, and extracting step are recited at a high level of generality and are well-understood, routine, and conventional activities as evidenced by WO 2019133926 (¶6; ¶73), NPL “Validation of beat by beat fetal heart signals acquired from four-channel fetal phonocardiogram with fetal electrocardiogram in healthy late pregnancy” (page 3, Phonogram Signal recording section; Figs. 1-2; page 5, last ¶; Fig. 5), NPL “An IoT Based Multi-Parameter Data Acquisition System for Efficient Bio-Telemonitoring of Pregnant Women at Home” (page 619, section 4), US 20180000405 (¶101), and US 20180108440 (¶54-55; ¶59; ¶80).
The 101 rejection is maintained and has been updated to reflect the amendments.
Claim Rejections - 35 USC § 103
The 103 rejection has been withdrawn. See the Examiner’s Note section below.
Claim Objections
Claim 21 is objected to because of the following informalities: “heath” should read –health--.  Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA  35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.  The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph:
(A)	the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B)	the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C)	the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.  Such claim limitation(s) is/are:
a securing device in claims 1, 17, 21, and 25; and
noise attenuator in claim 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For “securing device” in claims 1, 7, 21, and 25 the specification recites a belt or adhesive patch (¶28). Therefore, the Examiner is interpreting the securing device to be a belt or adhesive patch.
For “noise attenuator” in claim 16, the specification recites “the noise attenuator comprises at least one of: circuitry including an amplifier, a signal processor, or a general - purpose processor” (¶76). The Examiner is interpreting the noise attenuator to be an amplifier, a signal processor, or a general purpose processor.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, applicant may:  (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 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.
Step 1
The claimed invention in claims 1, 4-5, 7-9, 11, 13-14, 16-17, 19-21, 23, and 25 are directed to statutory subject matter as the claims recite a wearable fetal health monitoring device, a method, and a non-transitory computer-readable storage medium for determining a health condition of a fetus based on biosignals of an expecting mother and the fetus.
Step 2A, Prong One
Regarding claims 1, 17, and 21, the recited steps are directed to certain methods of organizing human activity and a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (II) and (III)).
Regarding claims 1, 17, and 21, the limitation of “providing an alert to the expecting mother based on the fHRV data, wherein the alert is indicative of a medical emergency” is a process, as drafted, covers performance of the limitation that is directed to organizing human activity (managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions). For example, this limitation is nothing more than a medical professional verbally communicating the medical emergency to the mother.
Regarding claims 1, 17, and 21, the limitation of “determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional receiving a print out of fPCG data and making an evaluating of the fHRV based off of the data.
Step 2A, Prong Two
For claims 1, 17, and 21, the judicial exception is not integrated into a practical application. In particular, claims 1, 17, and 21 recite “an acoustic sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from a first location on a maternal torso; an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso, wherein the first location and the second location are mutually exclusive; a securing device configured to provide skin contact of the acoustic sensor and the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring, a microcontroller/processor configured for 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; 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.” The acoustic sensor, optical sensor, securing device, and decomposing step amount to nothing more than pre-solution activity of data gathering. The microcontroller/processor and mode transitioning step are recited at a high-level of generality and amount to nothing more than a part of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional elements of an acoustic sensor, an optical sensor, a securing device, decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data, and extracting mechano-acoustically sensed fetal phonocardiogram (fPCG) data amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the acoustic sensor, optical sensor, securing device, decomposing step, and extracting step are recited at a high level of generality and are well-understood, routine, and conventional activities as evidenced by WO 2019133926 (¶6; ¶73), NPL “Validation of beat by beat fetal heart signals acquired from four-channel fetal phonocardiogram with fetal electrocardiogram in healthy late pregnancy” (page 3, Phonogram Signal recording section; Figs. 1-2; page 5, last ¶; Fig. 5), NPL “An IoT Based Multi-Parameter Data Acquisition System for Efficient Bio-Telemonitoring of Pregnant Women at Home” (page 619, section 4), US 20180000405 (¶101), and US 20180108440 (¶54-55; ¶59; ¶80). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). In this case, elements of general computer are being used to implement the abstract idea.
Regarding dependent claims 4-5, 7-9, 11, 13-14, 16, 19-20, 23, and 25, the limitations of claims 1, 17, and 21 further define the limitations already indicated as being directed to the abstract idea.
Examiner’s Note
Claims 1, 4-5, 7-9, 11, 13-14, 16-17, 19-21, 23, and 25 distinguish over the prior art but are still rejected under 35 USC § 101.
The following is a statement of reasons for the indication of allowable subject matter:
The scope of a fetal health monitoring device configured to use the 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.
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

NEXT 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

CITED REFERENCE SUMMARIES: Ref US20180000405: Claims:
1. A modular system for monitoring health parameters of a user, the modular system comprising:
a housing comprising: a plurality of sensors disposed on an outer surface of the housing or within the housing for measuring a plurality of parameters of interest; a processor disposed in the housing and communicatively coupled to the plurality of sensors; a coupling element positioned on the outer surface the housing for coupling the housing to an accessory; and an accessory identifier positioned on the housing or within the housing, the accessory identifier communicatively coupled to the processor,
wherein the housing is reversibly transitionable between an uncoupled state and a coupled state with the accessory, and
wherein, in the coupled state, the accessory identifier senses a type of accessory and the processor activates a subset of the plurality of sensors to measure a subset of the plurality of parameters of interest.
2. The modular system of claim 1, wherein the subset of the plurality of parameters of interest measured changes based on the type of accessory coupled to the housing.
3. The modular system of claim 1, wherein the accessory identifier comprises a plurality of electrical terminals.
4. The modular system of claim 3, wherein, in the coupled state, the plurality of electrical terminals is connected to a plurality of electrical receptacles on the accessory, and wherein an impedance between the plurality of electrical receptacles is detectable by the accessory identifier.
5. The modular system of claim 1, wherein the accessory is one or more of: wearable by a user and positionable proximate a user.
6. The modular system of claim 1, further comprising an antenna and transceiver communicatively coupled to the processor, wherein the antenna and transceiver wirelessly transmit the subset of the plurality of parameters of interest to a computing device.
7. The modular system of claim 6, wherein the subset of the plurality of parameters of interest are displayable to a user on a display of the computing device.
8. The modular system of claim 7, wherein a graphical user interface displayed on the display of the computing device adapts based on the type of accessory identified.
9. The modular system of claim 1, wherein the plurality of sensors includes one or more of: a physiological sensor, a bio-potential sensor, an activity sensor, an optical sensor, a bio-impedance sensor, an acoustic sensor, an ultrasound sensor, an electrochemical sensor, a near-infrared spectroscopy sensor, and a temperature sensor.
10. The modular system of claim 1, wherein the type of accessory is one of a wristband, a bra clip, a first trimester belly patch, a second trimester belly patch, a third trimester belly patch, a pregnancy support belt, a patch coupled to baby clothing, and an accessory integrated into clothing.
11. The modular system of claim 1, wherein during pre-conception, the plurality of sensors measure one of: a paternal subset of the plurality of parameters of interest and a maternal subset of the plurality of parameters of interest.
12. The modular system of claim 9, wherein the paternal subset of the plurality of parameters of interest include one or more of: an activity level, a sleep quality, a stress level, an oxygen saturation level, a cardiorespiratory fitness level, a heart rate, and a heart rate variability.
13. The modular system of claim 9, wherein the maternal subset of the plurality of parameters of interest include one or more of: an activity level, a sleep quality, a stress level, an oxygen saturation level, a cardiorespiratory fitness level, a heart rate, and a heart rate variability.
14. The modular system of claim 1, wherein during pregnancy, the plurality of sensors measures a maternal subset of the plurality of parameters of interest and a fetal subset of the plurality of parameters of interest.
15. The modular system of claim 14, wherein the maternal subset of the plurality of parameters of interest include one or more of: an electrohysterography signal, maternal uterine activity, maternal uterine contractions, maternal heart electrical activity, maternal heart rate, maternal heart rate variability, a maternal activity level, a maternal sleep quality, a maternal oxygen saturation level, a maternal cardiorespiratory fitness level, and a maternal stress level.
16. The modular system of claim 14, wherein the fetal subset of the plurality of parameters of interest include one or more of: fetal movement, fetal heart electrical activity, fetal heart sound, fetal heart rate, fetal heart rate variability, an amount of amniotic fluid, placental oxygenation, placental temperature, placental pH, fetal breathing, fetal position, fetal orientation, and fetal distress.
17. The modular system of claim 1, wherein during post-partum, the plurality of sensors measure one of: a maternal subset of the plurality of parameters of interest, a newborn subset of the plurality of parameters of interest, and a paternal subset of the plurality of parameters of interest.
18. The modular system of claim 17, wherein the maternal subset of the plurality of parameters of interest include one or more of: an activity level, a sleep quality, stress level, an oxygen saturation level, a cardiorespiratory fitness level, heart rate, and heart rate variability.
19. The modular system of claim 17, wherein the newborn subset of the plurality of parameters of interest include one or more of: a heart rate, heart rate variability, blood oxygenation level, breathing rate, movement, temperature, and vocal sounds.
20. The modular system of claim 17, wherein the paternal subset of the plurality of parameters of interest include one or more of: an activity level, a sleep quality, a stress level, an oxygen saturation level, a cardiorespiratory fitness level, a heart rate, and a heart rate variability.
21. The modular system of claim 1, wherein the modular system is configured for use with a plurality of users and to identify each of the plurality of users based on an identification of the accessory coupled to the housing.
22. A system for measuring health parameters of a user, the system comprising:
a plurality of sensors for measuring a plurality of parameters of interest of a user; a coupling element for coupling the system to an accessory worn by or positionable proximate the user; and a processor communicatively coupled to the plurality of sensors,
wherein the processor analyzes a plurality of sensor outputs from the plurality of sensors and automatically determines a type of the accessory coupled to the system based on the analyzed plurality of sensor outputs.
23. The system of claim 22, wherein the plurality of parameters of interest of the user includes one or more of: a maternal activity level, maternal sleep quality, maternal stress level, maternal oxygen saturation level, maternal cardiorespiratory fitness level, maternal heart rate, maternal heart rate variability, maternal electrohysterography signal, maternal uterine activity, maternal uterine contractions, maternal heart electrical activity, paternal activity level, paternal sleep quality, paternal stress level, paternal oxygen saturation level, paternal cardiorespiratory fitness level, paternal heart rate, paternal heart rate variability, paternal heart electrical activity, fetal movement, fetal heart electrical activity, fetal heart sound, fetal heart beat, fetal heart rate, fetal heart rate variability, an amount of amniotic fluid, placental oxygenation, placental temperature, placental pH, fetal breathing, fetal position, fetal orientation, fetal distress, fetal breathing movement, newborn heart rate, newborn blood oxygenation level, newborn breathing rate, newborn movement, newborn temperature, and newborn vocal sounds.
Ref US20180108440: Claims:
1. A system for receiving and transducing biological events into electrical signals and diagnosing a medical condition based thereon, the system comprising:
a sensor array comprising a vibro-acoustic sensor for measuring body sounds of a target living organism and a bio-electric sensor for measuring a bio-electric signal of the target living organism; a processor; and a machine learning module, executable by the processor and trained on signals characteristic of the sensor array, the machine learning module receiving signals from the sensors and, based on the training, outputting a probability indicative of a physiological condition.
2. The system of claim 1, wherein the physiological condition is a biomarker.
3. The system of claim 1, wherein the sensor array further comprises one or more sensors for measuring at least one environmental stimulus or condition.
4. The system of claim 3, wherein the at least one environmental stimulus or condition is at least one of skin temperature, ambient temperature, barometric pressure, 9-axis motion geolocation, location-dependent real-time weather conditions, galvanic skin response, or pollution.
5. The system of claim 1, wherein the sensor array comprises at least one sensor for measuring at least one of wavelength transmittance/absorbance, oxygen saturation, ambient skin temperature, core temperature, ACG, BCG, VCG, EKG, EMG, EOG, EEG, VOC excretion or vocal tonal inflection.
6. The system of claim 1, wherein the sensor array further comprises an optical sensor.
7. The system of claim 1, further comprising a database of longitudinal health records, the health record of a target living organism being monitored by the sensors providing an input to the machine learning module.
8. The system of claim 1, wherein the machine learning module is a neural network.
9. The system of claim 8, wherein the neural network is a recurrent neural network.
10. The system of claim 8, wherein the neural network is a feedforward neural network.
11. The system of claim 8, wherein the neural network is an ensemble of neural networks.
12. The system of claim 1, wherein the vibro-acoustic sensor and the bio-electric sensor each produce time-varying signals, the signals received by the machine learning module from the vibro-acoustic sensor and the bio-electric sensor being time-synchronized.
13. The system of claim 12, wherein the signals are received by the machine learning module as catenated raw amplitude sequences.
14. The system of claim 12, wherein the signals are received by the machine learning module as combined short-time Fourier transform spectra.
15. The system of claim 1, wherein the sensor array is connected by wires.
16. The system of claim 1, wherein the sensor array communicates wirelessly.
17. The system of claim 1, wherein the machine learning module is remote from the sensors and in communication therewith via a network.
18. The system of claim 1, further comprising at least one acoustic stimulus generators.
Ref WO2019133926: Claims:
Claims We claim: 1. A method comprising: receiving, by a processor, a plurality of detected electronic signals, each of the plurality of detected electronic signals being received from a separate detector communicatively coupled to the processor and corresponding to a detected optical signal emanating from a pregnant mammal’s abdomen and a fetus contained therein, wherein each detected optical signal has been converted, by the respective detector, into one of the plurality of the detected electronic signals; performing, by the processor, independent component analysis on the plurality of detected electronic signals to separate signals within the detected electronic signals that are contributed by different sources, each of the separated signals corresponding to a different source; determining, by the processor, a separated signal that corresponds to light incident upon the fetus; analyzing, by the processor, a separated signal that corresponds to light incident upon the fetus to determine a fetal hemoglobin oxygen saturation level of the fetus; and facilitating, by the processor, provision of an indication of the fetal hemoglobin oxygen saturation level to a user. 2. The method of claim 1 , wherein the separated signal that corresponds to light incident upon the fetus is a fetal photoplethysmogram signal. 3. The method of claim 1 or 2, wherein the source of a separated signal is at least one of a maternal photoplethysmogram, a fetal photoplethysmogram, a maternal respiratory signal, a uterine tone signal, and a noise signal. 4. The method of any of claims 1-3, further comprising: analyzing, by the processor, a separated signal that corresponds to light incident upon the pregnant mammal; and facilitating, by the processor, provision of an indication of the analysis results to the user. 5. The method of claim 4, wherein the separated signal that corresponds to light incident upon the pregnant mammal is at least one of a maternal photoplethysmogram signal, a maternal respiratory signal, and a uterine tone signal. 6. The method of any of claims 1-5, further comprising: filtering, by the processor, the received plurality of detected electronic signals prior to performance of the independent component analysis. 7. The method of any of claims 1-5, further comprising: receiving, by the processor, a secondary signal; and filtering, by the processor, the received plurality of detected electronic signals using the received secondary signal prior to performance of the independent component analysis. 8. The method of claim 7, further comprising: synchronizing, by the processor, the secondary signal and the received plurality of detected electronic signals prior to filtering the received plurality of detected electronic signals. 9. The method of any of claims 1-8, wherein the optical signal includes at least two different wavelengths of light. 10. A method comprising: receiving, by a processor, a plurality of detected electronic signals, each of the plurality of detected electronic signals being received from a separate detector communicatively coupled to the processor and corresponding to a detected optical signal emanating from a pregnant mammal’s abdomen and a fetus contained therein, wherein each detected optical signal has been converted, by the respective detector, into one of the plurality of the detected electronic signals; receiving, by the processor, a secondary signal; filtering, by the processor, the received plurality of detected electronic signals using the received secondary signal; performing, by the processor, independent component analysis on the plurality of filtered detected electronic signals to separate signals within the detected electronic signals that are contributed by different sources, each of the separated signals corresponding to a different source; determining, by the processor, a separated signal that corresponds to light incident upon the fetus; analyzing, by the processor, a separated signal that corresponds to light incident upon the fetus to determine a fetal hemoglobin oxygen saturation level of the fetus; and facilitating, by the processor, provision of an indication of the fetal hemoglobin oxygen saturation level to a user. 1 1. The method of claim 10, wherein the separated signal that corresponds to light incident upon the fetus is a fetal photoplethysmogram signal. 12. The method of any of claims 10 or 1 1 , wherein the source of a separated signal is at least one of a maternal photoplethysmogram, a fetal photoplethysmogram, a maternal respiratory signal, a uterine tone signal, and a noise signal. 13. The method of any of claims 10-12, further comprising: analyzing, by the processor, a separated signal that corresponds to light incident upon the pregnant mammal; and facilitating, by the processor, provision of an indication of the analysis results to the user. 14. The method of claim 13, wherein the separated signal that corresponds to light incident upon the pregnant mammal is at least one of a maternal photoplethysmogram signal, a maternal respiratory signal, and a uterine tone signal. 15. The method of any of claims 10-14, further comprising: amplifying, by the processor, the received plurality of detected electronic signals prior to performance of the independent component analysis. 16. The method of claim 15, further comprising: synchronizing, by the processor, the secondary signal and the received plurality of detected electronic signals prior to filtering the received plurality of detected electronic signals. 17. A method comprising: receiving, by a processor, a first detected electronic signal from a first detector, a second detected electronic signal from a second detector, and a third detected electronic signal from a third detector, each of the first, second, and third detectors being communicatively coupled to the processor and each of the first, second, and third detected electronic signals corresponding to a detected optical signal emanating from a pregnant mammal’s abdomen and a fetus contained that is detected by the respective first, second, and third detectors and converted into the respective first, second, and third detected electronic signals; performing, by the processor, independent component analysis on the first, second, and third detected electronic signals to generate a first separated signal, a second separated signal, and a third separated signal, the first separated signal, second separated signal, and third separated signal being contributed to the first, second, and third detected electronic signals by a first source, a second source, and a third source, respectively, wherein the third separated signal corresponds to a fetal photoplethysmogram signal; analyzing, by the processor, the third separated signal to determine a hemoglobin oxygen saturation level of the fetus; and facilitating, by the processor, provision of an indication of the hemoglobin oxygen saturation level of the fetus to a user. 18. The method of claim 17, wherein the first source of the first separated signal is at least one of motion artifacts of the pregnant mammal, respiration of the pregnant mammal, photoplethysmogram variations of the pregnant mammal, uterine tone of the pregnant mammal, and noise. 19. The method of claim 17, wherein the second source of the second separated signal is at least one of motion artifacts of the pregnant mammal, respiration of the pregnant mammal, photoplethysmogram variations of the pregnant mammal, uterine tone of the pregnant mammal, and noise. 20. The method of claim 17, further comprising: receiving, by the processor, a fourth detected electronic signal from a fourth detector communicatively coupled to the processor prior to performance of the independent component analysis, the fourth detected electronic signal corresponding to a detected optical signal emanating from the pregnant mammal’s abdomen and fetus contained that is detected by the fourth detector and converted into the fourth detected electronic signal, wherein the independent component analysis is performed on the first, second, third, and fourth detected electronic signals to generate the first separated signal, the second separated signal, the third separated signal, and a fourth separated signal, the fourth separated signal being contributed by a fourth source. 21. The method of claim 20, wherein the fourth source of the fourth separated signal is at least one of motion artifacts of the pregnant mammal, respiration of the pregnant mammal, photoplethysmogram variations of the pregnant mammal, uterine tone of the pregnant mammal, and noise.
A method comprising: receiving, by a processor, a plurality of detected electronic signals, each of the plurality of detected electronic signals being received from a separate detector communicatively coupled to the processor and corresponding to a detected optical signal emanating from a pregnant mammal’s abdomen and a fetus contained therein, wherein each detected optical signal has been converted, by the respective detector, into one of the plurality of the detected electronic signal
[Truncated to input limit]