Office Action 1: Non-Final Rejection (2023-06-07)
Rejection types: 101 - Patent-Eligible Subject Matter, 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
CLAIMS

What is claimed is:

1\. A wearable fetal health monitoring device for determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus, the device comprising:
a microelectromechanical system (MEMS) accelerometer that converts an acoustic wave sensed in an abdominal region into an abdominal acoustic signal;
a pulse oximeter that generates a maternal photoplethysmogram (mPPG) value from a pulse sensed in the abdominal region; and
a microcontroller configured to:
generate a maternal phonocardiogram (mPCG) value from the abdominal acoustic signal;
calculate a first maternal heart rate (mHR) value from the mPCG value;
calculate a second mHR value from the mPPG value:
compare the first mHR value with the second mHR value to identify a noise correction value:
apply the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG) value.

2\. The device of claim 1, further comprising at least one of: a power source operatively coupled to a wireless transceiver, a memory, and an electrode.

3\. The device of claim 1, wherein the microcontroller is further configured to calculate from the fPCG value at least one of: a fetal heart rate (fHR) value and a fetal heart rate variability (fHRV) value.

4\. The device of claim 1, wherein the microcontroller is further configured to calculate a fetal movement (fM) value from the abdominal acoustic signal.

5\. The device of claim 1, wherein the pulse oximeter is further configured to sense a maternal peripheral capillary oxygen saturation (mSpO2) value.

6\. The device of claim 1, wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor.

7\. The device of claim 1, wherein the microcontroller is further configured to calculate a maternal activity level from at least one of the mPPG value and the first mHR value and the second mHR value.

8\. The device of claim 1, further comprising one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope.

9\. The device of claim 1, further comprising a patch that removably attaches to a maternal torso.

10\. The device of claim 1, wherein the device comprises two units spaced apart from each other, wherein the two units are carried on a belt or band that surrounds a maternal torso.

11\. The device of claim 1, wherein the device further comprises an acoustic impedance matching housing.

12\. The device of claim 1, wherein the microcontroller is further configured to deconvolute the abdominal acoustic signal using at least one of the first mHR value and the second mHR value.

13\. The device of claim 1, further comprising an inclinometer sensor that detects a sub- audible abdominal acoustic wave.

14\. The device of claim 1, wherein a first portion of the device is disposable, and wherein a second portion of the device is re-usable.

15\. The device of claim 1, further comprising a ferroelectric nanogenerator sensor that detects abdominal pressure waves.

16\. The 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\. A method of determining a 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:
a microelectromechanical system (MEMS) accelerometer that converts an acoustic wave sensed in an abdominal region into an abdominal acoustic signal;
a pulse oximeter that generates a maternal photoplethysmogram (mPPG) value from a pulse sensed in the abdominal region; and
a microcontroller configured to:
generate a maternal phonocardiogram (mPCG) value from the abdominal acoustic signal;
calculate a first maternal heart rate (mHR) value from the mPCG value;
calculate a second mHR value from the mPPG value;
compare the first mHR value with the second mHR value to identify a noise correction value;
apply the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG) value. generating a maternal phonocardiogram (mPCG) value from the abdominal acoustic signal;
calculating a first maternal heart rate (mHR) value from the mPCG value;
calculating a second mHR value from the mPPG value;
comparing the first mHR value with the second mHR value to identify a noise correction value;
applying the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG) value.

18\. The method of claim 17, further comprising calculating from the fPCG value at least one of: a fetal heart rate (fHR) value and a fetal heart rate variability (fHRV) value.

19\. The method of claim 17, further comprising outputting at least one of a normal state, caution state, and emergency state based on the extracted fetal phonocardiogram (fPCG) value.

20\. The method of claim 17, further comprising calculating a fetal movement (fM) value from the abdominal acoustic signal. 23 24 25 26

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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/25/21 is being considered by the examiner.
Drawings
The drawings are objected to because Figs. 1A, 1B, 2, 3A, 3C, 3D, 5, and 6 appear blurry and are difficult to read. The replacement sheet for Figs. 3B and Fig. 4 are clear and visible. Appropriate correction is required for the blurry and unclear Figs. recited above. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 17 is objected to because of the following informalities: Applicant is encouraged to delete lines 18-25 after the period since it is repetitive.  Additionally, a claim can only have one period. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA  35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA  35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For the limitation of “deconvolute the abdominal acoustic signal” in claim 12, this is a computer implemented functional limitation “source separation algorithm decomposes the abdominal acoustic signal” according to ¶56 of the disclosure. ¶56 of the specification fails to disclose how the machine learning algorithm is used to deconvolute the abdominal acoustic signal using at least one of the first mHR value and the second mHR value. MPEP 2161.01(I) states the following:
Claims may lack written description when the claims define the invention in functional language
specifying a desired result but the specification does not sufficiently describe how the function is
performed or the result is achieved. For software, this can occur when the algorithm or
steps/procedure for performing the computer function are not explained at all or are not
explained in sufficient detail (simply restating the function recited in the claim is not necessarily
sufficient). In other words, the algorithm or steps/procedure taken to perform the function must
be described with sufficient detail so that one of ordinary skill in the art would understand how
the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection
IV.”
Therefore, the claims with the limitation of “deconvolute the abdominal acoustic signal” are rejected under 112(a) for failing to meet the written description requirement.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA  35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For the limitation of “identify a noise correction value” in claims 1 and 17, this is a computer implemented functional limitation “microcontroller is configured to…identify a noise correction value” according to ¶23 of the disclosure. ¶23 and ¶42 of the specification fail to disclose how the comparison creates a noise correction value. This limitation is a functional result without any steps indicating how the result is actually obtained. See MPEP 2161.01(I) above. Therefore, the claims with the limitation of “identify a noise correction value” are rejected under 112(a) for failing to meet the written description requirement. Dependent claims are rejected for the same deficiency set forth for independent claims 1 and 17.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 9 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism.  See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 9 includes the limitation of “a patch that removable attaches to a maternal torso.” As such, the limitation requires that a patch would encompass being in contact with a patient (human organism) under the broadest reasonable interpretation. Applicant should be recommended to change the claimed limitation to –a patch configured to removably attach to a maternal torso-- in order to overcome this 101 rejection.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea (mathematical concept of “calculate a first maternal heart rate (mHR) value from the mPCG value and calculate a second mHR value from the mPPG value”  and mental process of “compare the first mHR value with the second mHR value to identify a noise correction value”) without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a wearable fetal health monitoring device and a method 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 and 17, the recited steps are directed to mathematical concepts 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 (I) and (III)).
Regarding claims 1 and 17, the limitations of “calculate a first maternal heart rate (mHR) value from the mPCG value and calculate a second mHR value from the mPPG value” are mathematical calculations of calculating a maternal heart rates in order to apply a noise correct value to the fetal phonocardiogram.
Regarding claims 1 and 17, the limitation of “compare the first mHR value with the second mHR value to identify a noise correction value” 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, these limitations are nothing more than a medical professional evaluating a noise correction value based on judgement between a first mHR value and a second mHR value.
Step 2A, Prong Two
For claims 1 and 17, the judicial exception is not integrated into a practical application. In particular, claims 1 and 17 recite “a microelectromechanical system (MEMS) accelerometer, a pulse oximeter, and a microcontroller.” The microelectromechanical system (MEMS) accelerometer and pulse oximeter amount to nothing more than pre-solution activity of data gathering. The microcontroller is 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 a microelectromechanical system (MEMS) accelerometer and a pulse oximeter amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the MEMS accelerometer and pulse oximeter are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20180092564 (¶59-MEMS accelerometer) and US 20170281087 (¶21-pulse oximeter). 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 2-16 and 18-20, the limitations of claims 1 and 17 further define the limitations already indicated as being directed to the abstract idea.
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.
Claims 1-3, 7-9, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Holt (WO 2019133926 filed on 12/28/18) in view of Bureev (RU 2656518 filed on 3/6/14) and Meriheina (US 20180092564 filed on 10/2/17).
Regarding claims 1 and 17, Holt teaches a wearable fetal health monitoring device and method for determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus, the device comprising: a pulse oximeter that generates a maternal photoplethysmogram (mPPG) value from a pulse sensed in the abdominal region (¶6-maternal photoplethysmogram; ¶8-separated signal that corresponds to light incident upon the pregnant mammal (e.g., maternal photoplethysmogram); ¶73-pulse oximetry probe; ¶10-detected optical signal may correspond to an optical signal projected into the pregnant mammal’s abdomen by one or more light sources); calculate a second mHR value from the mPPG value (¶9-secondary signal (e.g. maternal heart rate); ¶8): and compare the first mHR value with the second mHR value to identify a noise correction value (¶75-the maternal heartrate signal may be used to determine which portions of the signals received in step 305 are contributed by the pregnant mammal. These portions may then be subtracted and/or divided from the signals received in step 305 to remove maternal contributions to the signals received in step 305). However, Holt does not teach a microelectromechanical system (MEMS) accelerometer that converts an acoustic wave sensed in an abdominal region into an abdominal acoustic signal and a microcontroller configured to: generate a maternal phonocardiogram (mPCG) value from the abdominal acoustic signal; calculate a first maternal heart rate (mHR) value from the mPCG; and apply the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG).
Bureev relates generally to medicine and obstetrics, in particular to medical diagnostics and can be used for mobile monitoring, and monitoring and evaluating the state of the fetus and method (page 4, top of page). Bureev more particularly relates to evaluating with maximum accuracy, the state of the fetus and mother, having a higher quality of registered signals, and increasing reliability and diagnostic value of produced data (page 9, middle of the page). Bureev further teaches the invention using the following steps:
generate a maternal phonocardiogram (mPCG) value from the abdominal acoustic signal (page 6, ¶2-placement on upper and lower part of abdomen of pregnant women, heart tones mother); calculate a first maternal heart rate (mHR) value from the mPCG value (bottom of page 8-heart rate mother); apply the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG) value (claim 1-attenuation of external noise and interference before subtracting of registered tones of fetus heart).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include generating a maternal phonocardiogram, a first maternal heart rate, and fetal phonocardiogram of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Meriheina relates generally to monitoring of heartbeats, particularly to monitoring of fetus and infant heartbeats with ballistocardiographic measurements. The present disclosure further relates to an analysis method and an apparatus which allow the weak ballistocardiographic signals caused by infant and fetus heartbeats to be distinguished from more dominant signal components, such as an adult's heartbeat (¶1). Meriheina further teaches a MEMS accelerometer (¶59). Meriheina further teaches the invention using the following steps:
a microelectromechanical system (MEMS) accelerometer that converts an acoustic wave sensed in an abdominal region into an abdominal acoustic signal (¶59-MEMS accelerometer); and a microcontroller (¶57-control unit 26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the MEMS accelerometer and microcontroller of Meriheina of the invention in Holt in order to allow the weak ballistocardiographic signals caused by infant and fetus heartbeats to be distinguished from more dominant signal components, such as an adult's heartbeat (Meriheina, ¶1).
Regarding claim 2, Holt teaches a power source operatively coupled to a wireless transceiver (¶25-wireless, power).
Regarding claims 3 and 18, Holt in view of Bureev and Meriheina teaches the device and the method of claims 1 and 17. However, Holt does not teach to calculate from the fPCG value at least one of: a fetal heart rate (fHR) value and a fetal heart rate variability (fHRV) value.
Bureev teaches calculating from the fPCG value at least one of: a fetal heart rate (fHR) value (bottom of page 8-heart rate of fetus) and a fetal heart rate variability (fHRV) value (top of page 9-cardiac rhythm variability of fetus).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include calculating from the fPCG value at least one of: a fetal heart rate (fHR) value and a fetal heart rate variability (fHRV) value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Regarding claim 7, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach calculating a maternal activity level from at least one of the mPPG value and the first mHR value and the second mHR value.
Bureev teaches wherein the microcontroller is further configured to calculate a maternal activity level from at least one of the mPPG value and the first mHR value and the second mHR value (page 5, middle of page-electrical activity of heart mother; bottom of page 8-heart rate mother).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include calculating a maternal activity level from at least one of the mPPG value and the first mHR value and the second mHR value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Regarding claim 8, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope.
Meriheina teaches one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope (¶35-gyroscope; ¶23).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope of Meriheina of the invention in Holt in order to allow the weak ballistocardiographic signals caused by infant and fetus heartbeats to be distinguished from more dominant signal components, such as an adult's heartbeat (Meriheina, ¶1).
Regarding claim 9, Holt teaches a patch that removably attaches to a maternal torso (¶46- an adhesive designed to be applied to the skin of the pregnant mammal’s abdomen (e.g., glue, tape, etc.) configured to apply housing 102/fetal hemoglobin probe 1 15 directly to the skin of the pregnant mammal’s abdomen and hold it in place there in a manner similar to a sticker).
Regarding claim 16, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach 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.
Bureev teaches 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 (claim 1-attentuation of external noise and interference; page 7, middle of page-combined in one housing with complex acoustic sensors 1 and 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date that the claimed invention include 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 of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Regarding claim 19, Holt in view of Bureev and Meriheina teaches the method of claim 17. However, Holt does not teach outputting at least one of a normal state, caution state, and emergency state based on the extracted fetal phonocardiogram (fPCG) value.
Bureev teaches outputting at least one of a normal state, caution state, and emergency state based on the extracted fetal phonocardiogram (fPCG) value (page 5, top of page- monitoring the fast changes of the state of the fetus; page 8, ¶2-emergency mode; page 6, ¶2-tones of the fetus heart; page 7, middle of page-digital or an analog output, is intended for recording tones of fetus heart).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date that the claimed invention include outputting at least one of a normal state, caution state, and emergency state based on the extracted fetal phonocardiogram (fPCG) value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Igney (US 20100305481 filed on 5/7/08).
Regarding claims 4 and 20, Holt in view of Bureev and Meriheina teaches the device and the method of claims 1 and 17. However, Holt does not teach calculating a fetal movement (fM) value from the abdominal acoustic signal.
Igney teaches calculating a fetal movement (fM) value from the abdominal acoustic signal (¶17-movements of the fetus)
Igney relates to a system and method for automatically monitoring the movement activity of a fetus (¶1). Igney additionally teaches an easy and completely unobtrusive way of monitoring the movement activity of an unborn child. With the present invention the evaluation and monitoring of child movements can be carried out completely automatically in a home environment (¶16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include calculating a fetal movement (fM) value from the abdominal acoustic signal of Igney of the invention in Holt in order to provide an easy and completely unobtrusive way of monitoring the movement activity of an unborn child. With the present invention the evaluation and monitoring of child movements can be carried out completely automatically in a home environment (Igney, ¶16).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Venugopalan (US 20170049414 filed on 5/22/15), hereinafter referred to as Ven.
Regarding claim 5, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach wherein the pulse oximeter is further configured to sense a maternal peripheral capillary oxygen saturation (mSpO2) value.
Venugopalan teaches wherein the pulse oximeter is further configured to sense a maternal peripheral capillary oxygen saturation (mSpO2) value (¶35-maternal pulse oximetry (SpO2); ¶43).
Ven relates generally to providing wireless sensor. More specifically the subject matter relates to a wireless sensor capable of communicating with a remote ultrasound processing system for managing fetal and maternal data (¶1). Ven also relates to the fetal and maternal data being examined by a medical practitioner to determine the health status of the fetus and the subject (¶6). Ven further teaches the maternal pulse oximetry (SpO2) (¶35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the mSpO2 value of Ven of the invention in Holt in order to provide a wireless fetal sensor and system for managing fetal data and maternal data of a subject, so that the fetal and maternal data can be examined by a medical practitioner to determine the health status of the fetus and the subject (Ven, ¶6).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Stahmann (US 7787946 filed on 9/1/04).
Regarding claim 6, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor.
Stahmann teaches wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor (col. 238 and lines 19-28-accelerometer based acoustic sensors, MEMS-based acoustic sensors).
Stahmann relates generally to systems and methods providing patient monitoring, diagnosis and/or therapy (Field of the Invention section). Stahmann further teaches one or more functions of two or more individual medical procedures may be used in combination to enhance patient monitoring, diagnosis and/or therapy (col. 2 and lines 52-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor of Stahmann of the invention in Holt in order for one or more functions of two or more individual medical procedures may be used in combination to enhance patient monitoring, diagnosis and/or therapy (Stahmann, col. 2 and lines 52-54).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Workman (US 20170281087 as cited in the IDS and filed on 3/31/17).
Regarding claim 10, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach wherein the device comprises two units spaced apart from each other, wherein the two units are carried on a belt or band that surrounds a maternal torso.
Workman teaches wherein the device comprises two units spaced apart from each other, wherein the two units are carried on a belt or band that surrounds a maternal torso (¶20-the belly-covering garment 140 may comprise a belt or a stray that is capable of holding the sensor modules sensor modules 120(a-d) adjacent to the belly 100; Fig. 1).
Workman relates generally to a system for monitoring fetal health data and/or mother health data. Workman further teaches a belly-covering garment that is configured to at least partially cover a belly and to hold one or more sensor modules directly adjacent to the belly (¶5). Workman additionally teaches determining whether the fetus is within the first region or the second region based upon readings received from the first sensor module and the second sensor module (¶7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include wherein the device comprises two units spaced apart from each other, wherein the two units are carried on a belt or band that surrounds a maternal torso of Workman of the invention in Holt in order to determine whether the fetus is within the first region or the second region based upon readings received from the first sensor module and the second sensor module (Workman, ¶7).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Zia (US 20140180153 filed on 12/23/13).
Regarding claim 11, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach an acoustic impedance matching housing.
Zia teaches wherein the device further comprises an acoustic impedance matching housing (¶32-acoustically impedance matched, housing).
Zia relates generally to medical diagnostic systems, and more particularly, to a system and method for acoustic detection of coronary artery disease and automated editing of heart sound data (¶3). Zia also teaches systems and methods for adaptively canceling noise in an acoustic heart signal and/or automatically editing heart sound data (¶10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include an acoustic impedance matching housing of Zia of the invention of Holt in order for adaptively canceling noise in an acoustic heart signal and/or automatically editing heart sound data (Zia, ¶10).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Chen (WO 2018148251 filed on 2/7/18).
Regarding claim 12, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach wherein the microcontroller is further configured to deconvolute the abdominal acoustic signal using at least one of the first mHR value and the second mHR value.
Bureev the abdominal acoustic signal (page 6, ¶2-placement on upper and lower part of abdomen of pregnant women, heart tones mother) using the first mHR value (bottom of page 8-heart rate mother).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the abdominal acoustic signal and using the first mHR value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Chen teaches wherein the microcontroller is further configured to deconvolute (¶98-deconvoluting mixed signals with respect to the identified sources, heart sound).
Chen relates generally to a methodology is disclosed that enables calculation of the systolic and diastolic blood pressures continuously in a non-invasive manner, based on the heart sounds measured from the chest of a human being (¶47). Chen also teaches deconvoluting mixed signals (¶98).  Chen also teaches analyzing acoustic signals, locating and separating noise sources via multi-channel microphones as an effective approach for both airborne and structural-born noise problems (¶99).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the deconvolution of Chen of the invention in Holt in order analyze acoustic signals, locate and separate noise sources via multi-channel microphones as an effective approach for both airborne and structural-born noise problems (Chen, ¶99).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Ransbury (US 20180317789 filed on 5/2/18).
Regarding claim 13, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach an inclinometer sensor that detects a sub- audible abdominal acoustic wave.
Ransbury teaches an inclinometer sensor that detects a sub-audible abdominal acoustic wave (¶37-inclinometer; ¶30-acoustic waveforms; ¶31-sub-audile frequencies).
Ransbury relates generally to methods and systems for remote monitoring of heart activity (¶2). Ransbury more particularly relates to a wearable heart monitoring device for monitoring heart activity comprising one or more acoustic sensors, including at least one microphone configured to operate in a frequency range related to human hearing, and at least one accelerometer configured to operate in the range of low or sub-audible frequencies (¶4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include an inclinometer sensor that detects a sub- audible abdominal acoustic wave of Ransbury of the invention in Holt in order to operate in the range of low or sub-audible frequencies and analyzing the data collected by the one or more sensors to determine a condition of a heart (Ransbury, ¶9).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Khine (US 20170086709 A1 as cited in the IDS and filed on 5/18/15).
Regarding claim 14, Holt in view of Bureev and Meriheina teaches the device of claim 1. However, Holt does not teach wherein a first portion of the device is disposable, and wherein a second portion of the device is re-usable.
Khine teaches wherein a first portion of the device is disposable, and wherein a second portion of the device is re-usable (¶70-a disposable patient interface; ¶95-reusable component).
Khine relates generally to a wearable sensor for monitoring fetal movement (e.g., fetal kicks) and/or health. The disclosure relates to technology for monitoring fetal health during later stages (e.g., weeks 24+) of pregnancy. More specifically, a sensor can be worn by a mother to extract biometric data about the fetus. This data can be used as an indirect indicator of fetal health (¶9). Khine further teaches that this wearable sensor is less cumbersome then existing technology to improve user compliance. With continuous monitoring a decline in fetal movement can be detected earlier then without this device (¶10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include wherein a first portion of the device is disposable, and wherein a second portion of the device is re-usable of Khine of the invention in Holt in order to improve user compliance and with continuous monitoring a decline in fetal movement can be detected earlier then without this device (Khine, ¶10).
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NPL “Validation of beat by beat fetal heart signals acquired from four-channel fetal phonocardiogram with fetal electrocardiogram in healthy late pregnancy” a copy has been furnished with this office action
NPL “Trends in fetal monitoring through phonocardiography: Challenges and future directions” a copy has been furnished with this office action
Allowable Subject Matter
Claim 15 overcomes the prior art but still has pending 101 and 112 rejection, so the claim is not currently allowable.
The following is a statement for the indication of the claim overcoming the prior art:
a ferroelectric nanogenerator sensor that detects abdominal pressure waves
The above limitation was not found in the prior art alone or in combination to be obvious over the prior art of record. The closest prior art of record is WO 2019133926; however it fails to recite the ferroelectric nanogenerator.
Conclusion

APPLICANT REBUTTAL: Amendments to the Drawings:
These replacement sheets replace the original sheets for FIGS. 1A, 1B, 2, 3A, 3C. 3D, 5, and 6.
Attachment: Replacement Sheets
REMARKS
Applicant has carefully reviewed the non-final Office Action mailed on June 7, 2023 and offers the following remarks to accompany the above amendments.
Summary of Remarks
With respect to the rejected claims (and as indicated in the Office Action), the cited art fails to disclose or suggest a wearable fetal health monitoring device for determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus as recited in claim 1 that includes a ferroelectric nanogenerator sensor that detects abdominal pressure waves.
Status of the Claims
Claims 1-20 were previous pending. Claims 1, 9, and 17 are amended herein. Claim 15 is canceled herein. Claim 21 is added herein. As such, claims 1-14 and 16-21 remain pending.
Drawings
The drawings are objected to because FIGS. 1A, 1B, 2, 3A, 3C, 3D, 5, and 6 are difficult to read. Applicant has provided replacement sheets for FIGS. 1A, 1B, 2, 3A, 3C. 3D, 5, and 6 herein.
Accordingly, it is respectfully submitted that the objection to the drawings be withdrawn.
Claim Objections
Claim 17 is objected to because informalities: Applicant has amended claim 17 to delete lines 18-25 after the period as indicated by the Office Action.
Accordingly, it is respectfully submitted that the objection to claim 17 be withdrawn.
Claim Rejections - 35 USC § 112
Claim 1, 12, and 17 stand rejected under 35 U.S.C. 112 as failing to comply with the written description requirement. The Office Action contends the subject matter was not described in the specification in such a way as to reasonably convey to a person of ordinary skill in the art had possession of the claimed invention.
Regarding claims 1 and 17, the Office Action further identifies the limitation reciting "identify a noise correction value" based on comparing "the first mHR value with the second mHR value." Applicant respectfully traverses the rejection. Applicant contends that a person of ordinary skill in the art would be in possession of knowledge of how to compare the first mHR value with the second mHR value to identify a noise correction value. Further in the rejection 35 USC § 103 of the above limitation, the Office Action contents that Holt (WO 2019133926 filed on 12/28/18) teaches the above limitation in paragraph [00075] as follows:
In some embodiments, execution of step 415 may include
processing one or more of the signals received in step 305 with a secondary signal received in step 410. For example, if the secondary signal is a maternal heartrate signal (as may be received from, for example, ECG device 170), then the maternal heartrate signal may be used to determine which portions of the signals received in step 305 are contributed by the pregnant mammal. These portions may then be subtracted and/or divided from the signals received in step 305 to remove maternal contributions to the signals received in step 305. Additionally, or alternatively, if the secondary signal is a fetal heartrate signal, then the fetal heartrate signal may be used to determine which portions of the
signals received in step 305 are contributed by the fetus because, for example, the oxygenation level of the fetus may fluctuate in a manner that corresponds to its pulse or heartrate. These portions of the signals received in step 305 may then be amplified by, for example, multiplying them by the fetal signal produced by subtracting portions of the maternal contributions from the signals received in step 305 and/or subtraction of portions of the signals received in step 305 that are not
contributed by the fetus.
Further in the rejection under 35 USC § 103 of the above limitation, the Office Action contents that Bureev (RU 2656518 filed on 3/6/14) teaches the above limitation in claim 1 as follows:
The method of daily monitoring of the condition of the fetus and
mother in the antenatal period of pregnancy, including recording heart sounds of the fetus and the expectant mother using sensors placed on the mother's abdomen, filtering, transmitting, processing, storing in a database and evaluating the data obtained with reference samples, characterized the fact that in addition to the continuous flow of signals of the heart sounds of the mother, the moment of absence of the heart tone of the mother is determined, and at this time the level of external noise is measured, the ratio of the amplitudes mentioned of weak signals and calculate the attenuation coefficient of external noise and interference, by which the signals of external noise are multiplied before summing with the signals of the heart sounds of the mother, and a similar procedure is performed for the signals of the heart sounds of the fetus
and external noise to proportionally attenuate the external noise and
interference before subtracting from the recorded tones fetal heart.
generate a maternal phonocardiogram (mPCG) value from the
abdominal acoustic signal (page 6, [2 -placement on upper and lower part of abdomen of pregnant women, heart tones mother); calculate a first maternal heart rate (mHR) value from the mPCG value (bottom of page 8- heart rate mother); apply the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG) value (claim 1- attenuation of external noise and interference before subtracting of
registered tones of fetus heart).
The Office Action further cites that it would have been obvious to a person of ordinary skill in the art to combine the references of Holt and Bureev to teach the limitations of claims 1 and 17 including the limitation of comparing the first mHR value with the second mHR value to identify a noise correction value. As such, the Applicant believes the above limitation was described in the specification in such a way as to reasonably convey to a person of ordinary skill in the art how to practice the claimed invention.
Regarding claim 12, the Office Action further identifies the limitation reciting "deconvolute the abdominal acoustic signal" based on "using at least one of the first mHR value and the second mHR value" Applicant respectfully traverses the rejection. Applicant contends that a person of ordinary skill in the art would be in possession of knowledge of how to deconvolute the abdominal acoustic signal using at least one of the first mHR value and the second mHR value. Further in the rejection 35 USC § 103 of the above limitation, the Office Action contents that Chen (WO 2018148251 filed on 2/7/18) teaches the above limitation in paragraphs [0047], [00098], and [0099] as follows:
[0047] A methodology is disclosed that enables calculation of the
systolic and diastolic blood pressures continuously in a non-invasive manner, based on the heart sounds measured from the chest of a human being. To this end, first and second heart sounds, known as Si and S2, are
separated from directly measured heart sound signals. Next, individual characteristics of Si and S2 are identified and correlated to systolic and diastolic blood pressures. As known, material properties of a human being are inhomogeneous, changing from one organ to another, and the speed at which the heart sound signals propagate inside a human body cannot always be determined precisely. Moreover, the exact locations from which the heart sounds are originated are estimated. As such, the disclosed method is semi-empirical. Yet, validation results have demonstrated that this semi-empirical computer model can produce robust and accurate calculations of the systolic and diastolic blood
pressures.
[0098] The following portion of the disclosure presents a
theoretical foundation for the disclosed methodology that enables the prediction of blood pressures based on the heart sounds measured directly on the chest of a patient. One aspect of this methodology is the separation of heart sounds into first heart sound and second heart sound, from which components attributable to four heart valves, i.e.: mitral; tricuspid; aortic; and pulmonary valve-closure sounds are separated. Because human physiology and anatomy can vary among people and are unknown a priori, such separation is called blind source separation. Moreover, the sources locations, their surroundings and boundary conditions are unspecified. Consequently, it is difficult to obtain an exact separation of signals. To circumvent this difficulty, the point source separation method is extended in this disclosure to an inhomogeneous fluid medium, and further combined with iteration schemes to search for approximate source locations and signal propagation speed. Once these are accomplished, the signals emitted
from individual sources are separated by deconvoluting mixed signals
with respect to the identified sources.
[0099] Blind Source Separation (BSS) aims at separating
individual signals from a set of mixed data collected by multiple sensors.
Applications of BSS have been found in almost all fields including analyzing bio-medical signals, speeches, machine health monitoring, radio communications, and others. In particular, in bio-acoustical fields, BSS have been used to improve speech recognition in bilateral cochlear implant patients, to analyze functional magnetic resonance imaging (fMRI) data, electroencephalography (EEG) signals, etc. In analyzing acoustic signals, locating and separating noise sources via multi-channel microphones is an effective approach for both airborne and structural- born noise problems. BSS also enables one to extract target vibration signals generated by a specific mechanical machine from directly measured data that have been contaminated by interfering signals emitted from other machines, which can be very helpful for machine
health monitoring and diagnosis.
The Office Action further cites that it would have been obvious to a person of ordinary skill in the art to combine Chen with the other cited references to teach the limitation of claims 1 and 12 including the limitation of "deconvoluting the abdominal acoustic signal using at least one of the first mHR value and the second mHR value." As such, the Applicant believes the above limitation was described in the specification in such a way as to reasonably convey to a person of ordinary skill in the art how to practice the claimed invention.
Accordingly, it is respectfully submitted that the rejection of claims 1, 12, and 17 under 35 USC § 112 be withdrawn.
Claim Rejections Under 35 U.S.C. 101
Claims 1-20 stand rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The Office Action further contends claims 1-20 are directed toward an abstract idea related to certain methods of organizing human activity such as commercial or legal interactions including advertising, marketing or sales activities or behaviors, or business relations and fail to pass Step 2A - Prong 1 of the Alice/Mayo analysis. Additionally, the Office Action contends claims 1-20 are not integrated into a practical application and fail to pass Step 2A - Prong 2 of the Alice/Mayo analysis. Finally, the Office Action contends claims 1-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception and fail to pass Step 2B of the Alice/Mayo analysis.
To further prosecution, claim 1 has been amended to include the allowable subject matter of claim 15 as follows:
A wearable fetal health monitoring device for determining a heath
condition of a fetus based on biosignals of an expecting mother and the
fetus, the device comprising:
a microelectromechanical system (MEMS) accelerometer that converts
an acoustic wave sensed in an abdominal region into an abdominal
acoustic signal;
a pulse oximeter that generates a maternal photoplethysmogram
(mPPG) value from a pulse sensed in the abdominal region;
a ferroelectric nanogenerator sensor that detects abdominal pressure
waves;
and
a microcontroller configured to:
generate a maternal phonocardiogram (mPCG) value from the
abdominal acoustic signal;
calculate a first maternal heart rate (mHR) value from the mPCG
value;
calculate a second mHR value from the mPPG value;
compare the first mHR value with the second mHR value to identify
a noise correction value;
and
apply the identified noise correction value to the mPCG value to
extract a fetal phonocardiogram (fPCG) value.
The following remarks will address claims 1-20 in regard to Step 2A - Prong 2 and Step 2B of the Alice/Mayo analysis.
Updates to the Federal Register / Vol 84. No. 4 on Monday, January 7, 2019 titled "2019 Revised Patent Subject Matter Eligibility Guidance" recites the following regarding Step 2A - Prong 2:
Prong Two represents a change from prior guidance. The analysis under Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural
phenomenon.
In the context of revised Step 2A, the following exemplary considerations are indicative that an   additional element (or combination   of elements) [24] may have integrated the exception into a practical
application:
e An    additional element reflects an  improvement in the
functioning of a computer, or an improvement to other technology
or technical field.
Additionally, slide 19 of the 2019 PEG -Advanced Module dated January 2019 identifies Step 2A as a two prong inquiry with updated guidance to Step 2A-Prong 2 as follows:
o Revised Step 2A: Prong Two
" New procedure not found in prior guidance:
e Identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and
e Evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. "  "Integration into a practical application"
e Requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting  effort designed  to  monopolize  the exception.
e  Uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application.
Further, page 11 of the USPTO Memorandum titled "October 2019 Update: Subject Matter Eligibility" recites the following regarding Step 2B -Prong 2:
"For example, if the additional limitations reflect an improvement in the functioning of a computer, or an improvement to another technology or
technical field, the claim integrates the judicial exception into a practical application and thus imposes a meaningful limit on the judicial exception.
No further analysis is required. The claim is eligible at Step 2A."
Amended claim 1 recites additional limitations that reflect an improvement of a technical field (e.g., determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus). More specifically, amended claim 1 recites a wearable fetal health monitoring device including additional limitations as follows:
a microcontroller configured to:
generate a maternal phonocardiogram (mPCG) value from the
abdominal acoustic signal;
calculate a first maternal heart rate (mHR) value from the mPCG
value;
calculate a second mHR value from the mPPG value;
compare the first mHR value with the second mHR value to identify
a noise correction value;
and
apply the identified noise correction value to the mPCG value to
extract a fetal phonocardiogram (fPCG) value.
In addition to the microcontroller of the wearable fetal health monitoring device, the claim is further limited by a microelectromechanical system (MEMS) accelerometer configured to convert an acoustic wave sensed in an abdominal region into an abdominal acoustic signal, a pulse oximeter configured to generate a maternal photoplethysmogram (mPPG) value from a pulse sensed in the abdominal region; and a ferroelectric nanogenerator sensor configured to detect abdominal pressure waves;
The microcontroller works in concert with the microelectromechanical system (MEMS) accelerometer; the pulse oximeter, and the ferroelectric nanogenerator sensor to extract a fetal phonocardiogram (fPCG) value. As such, determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus is improved.
A person of ordinary skill in the art would understand that such a method must be implemented on a computing device and to be practical to extract a fetal phonocardiogram (fPCG) value between heartbeats of the expecting mother and the fetus. Accordingly, amended claim 1 recites a practical application. As such for the reasons above, amended claim 1 passes Step 2A Prong Two of the Alice/Mayo analysis.
In the event the Patent Office believes amended claim 1 is still directed at a judicial exception that is not integrated into a practical application and fails to pass Step 2A of the Alice/Mayo analysis, a further analysis of amended claim 13 against Step 2B follows.
The following paragraph and reference are recited on page 51 in the updates to the Federal Register /Vol 84. No. 4 on Monday, January 7, 2019 titled "2019 Revised Patent Subject Matter Eligibility Guidance":
Finally, if further analysis at Step 2B is needed (for example to determine whether the claim merely recites well-understood, routine, conventional activity), this 2019 Revised Patent Subject Matter Eligibility Guidance explains that the examiner or administrative patent judge will proceed in
accordance with existing USPTO guidance as modified in April 2018.[6]
6. USPTO Memorandum of April 19, 2018, "Changes in Examination Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter
Eligibility Decision (Berkheimer v. HP, Inc.)" (Apr. 19, 2018),
The above USPTO Memorandum recites in Section III updated requirements for a Step 2B analysis of Alice/Mayo. As Applicant understands this guidance, the Examiner must support a 101 rejection using at least one of the following four points of the Memorandum to determine that the combination of elements are well-understood, routine or conventional in nature:
1. A citation to an express statement in the specification or to a statement
made by an applicant during prosecution that demonstrates the well-
understood, routine, conventional nature of the additional element(s).
A   specification  demonstrates  the  well-understood,  routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. @ 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with
respect to describing such element.
2. A citation to one or more of the court decisions discussed in MPEP @
(d)(II) as noting the well-understood, routine, conventional
nature of the additional element(s).
3. A citation to a publication that demonstrates the well-understood,
routine, conventional nature of the additional element(s). An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a "printed publication" as used in 35 U.S.C. @ 102.3. Whether something is disclosed in a document that is considered a "printed publication"
under 3 5 U.S. C @ 102 is a distinct inquiry from whether something is well-known, routine, conventional activity. A document may be a printed publication but still fail to establish that something it describes is well-understood, routine, conventional activity. See Exergen Corp., 2018 WL 1193529, at *4 (the single copy of a thesis written in German and located in a German university library considered to be a "printed
publication" in Hall "would not suffice to establish that something is 'well-understood, routine, and  conventional activity previously engaged in by scientists who work in the field"'). The nature of the publication and the description of the additional elements in the publication would need to demonstrate that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. @ 112(a). For example, while U.S. patents and published applications are publications, merely finding the additional element in a single patent or published application would not be sufficient to demonstrate that the additional element is well- understood, routine, conventional, unless the patent or published application demonstrates that the additional element are widely
prevalent or in common use in the relevant field.
4. A statement that the examiner is taking official notice of the well- understood, routine, conventional nature of the additional element(s).
This option should be used only when the examiner is certain, based upon his or her personal knowledge, that the additional element(s) represents well-understood, routine, conventional activity engaged in by those in the relevant art, in that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. @ 112(a). Procedures for taking official notice and addressing an applicant's challenge to official notice are discussed in MPEP @
.
Taking into account the above guidance, it is clear that the
additional elements
recited in the present claims amount to significantly more than the judicial exception and therefor are patent-eligible subject matter because the
additional elements
is not well- understood, routine, or conventional in nature as required by at least one of the above four points of the Memorandum.
Regarding point 1 of the Memorandum, nowhere has Applicant cited in the Specification, or during prosecution that the above
additional elements
would be well- understood, routine, or conventional in nature to a person of ordinary skill in the art at the priority date of the application.
Regarding point 2 of the Memorandum, Applicant is unaware of any court decisions discussed in MPEP § 2106.05(d)(II) as noting a well-understood, routine, or conventional in nature the above
additional elements.
Regarding point 3 of the Memorandum, the Office Action fails to cite any references that disclose the above
additional elements
as well-understood, routine, or conventional in nature. Specifically, the limitation of originally filed claim 15 now incorporated into amended claim 1.
Regarding point 4 of the Memorandum, the Examiner has not taken official notice in the Office Action that the above
additional elements
are well-understood, routine, or conventional in nature.
As such, amended claim 1 in addition to passing Step 2A also passes Step 2B of the Alice/Mayo analysis.
Claims 2-14 depend directly from amended claim 1 and are allowable at least by virtue of their dependence from amended claim 1.
Claim 15 has been cancelled rendering its rejection moot.
Claim 16 depends directly from amended claim 1 and is allowable at least by
virtue of its dependence from amended claim 1.
Claim 17 has been amended to include features that are similar to amended claim 1. As such claim 17 is also allowable.
Claims 18-20 depend directly for amended claim 17 and are allowable at least by virtue of its dependence from amended claim 17.
Accordingly, it is respectfully submitted that the rejection under 35 U.S.C. 101 of claims 1-14 and 16-20 be withdrawn.
Claim Rejections Under 35 U.S.C. @ 103
Claims 1-3, 7-9, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Holt (WO 2019133926 filed on 12/28/18) in view of Bureev (RU 2656518 filed on 3/6/14) and Meriheina (US 20180092564 filed on 10/2/17).
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Igney (US 20100305481 filed on 5/7/08).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Venugopalan (US 20170049414 filed on 5/22/15), hereinafter referred to as Ven.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Stahmann (US 7787946 filed on 9/1/04).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Workman (US 20170281087 as cited in the IDS and filed on 3/31/17).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Zia (US 20140180153 filed on 12/23/13)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Chen (WO 2018148251 filed on 2/7/18).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Ransbury (US 20180317789 filed on 5/2/18)
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev and Meriheina as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Khine (US 20170086709 Al as cited in the IDS and filed on 5/18/15)
Claim 1 has been amended to include the allowable subject matter of claim 15. As such amended claim 1 is now allowable.
Claims 2-14 depend directly from amended claim 1 and are allowable at least by virtue of their dependence from amended claim 1.
Claim 15 has been cancelled rendering its rejection moot.
Claim 16 depends directly from amended claim 1 and is allowable at least by virtue of its dependence from amended claim 1.
Claim 17 has been amended to include features that are similar to amended claim 1. As such claim 17 is also allowable.
Claims 18-20 depend directly for amended claim 17 and are allowable at least by virtue of its dependence from amended claim 17.
Accordingly, it is respectfully submitted that the rejection under 35 U.S.C. 103 of claims 1-14 and 16-20 be withdrawn.
New Claim
New claim 21 is added herein. New claim 21 contains features similar to amended claim 17. As such, new claim 21 is allowable. Additional support for new claim 21 may be found in at least paragraphs [0065] - [0068] of the Published Application for a non- transitory computer-readable storage medium that stores instructions to be implemented on a wearable fetal health monitoring device.
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 .
Status of Claims
Claims 1-14 and 16-21 are rejected. Claim 15 is canceled.
Response to Arguments
Drawing Objections
The drawing objections are withdrawn in view of Applicant submitting Replacement sheets of the indicated Figures that are clear and visible.
Claim Objection
The claim objection is withdrawn in view of Applicant’s amendment.
Claim Rejections - 35 USC § 112
Applicant's arguments filed 8/25/23 have been fully considered but they are not persuasive. Applicant argues that it would have been obvious to a person of ordinary skill in the art to combine the references of Holt and Bureev to teach the limitations of claims 1 and 17 including the limitation of comparing the first mHR value with the second mHR value to identify a noise correction value (Remarks, page 12). Applicant believes that above limitation was described in the specification in such a way as to reasonably convey to a person of ordinary skill in the art how to practice the claimed invention (Remarks, page 12). However, the Examiner disagrees. The limitation of a “noise correction value” is only recited in ¶5 and ¶23 of the specification. There are no further details provided about how the noise correction value is determined besides being based on a comparison of the first mHR value and the second mHR value. It remains unclear how this comparison determines the noise correction value. Is there a threshold involved? How is the noise correction value determined from the comparison?
Applicant's arguments filed 8/25/23 have been fully considered but they are not persuasive. Applicant argues that a person of ordinary skill in the art would be in possession of knowledge of how to deconvolute the abdominal acoustic signal using at least one of the first mHR value and the second mHR value (Remarks, page 12). Applicant believes that the deconvoluting step was described in the specification in such a way as to reasonably convey to a person of ordinary skill in the art how to practice the claimed invention (Remarks, page 14). However, the Examiner disagrees. The limitation of “deconvolute the abdominal acoustic signal” is only recited in ¶18 and ¶77 of the specification. No details are provided for how the microcontroller performs the deconvolution step. Further, MPEP 2161.01(I) states the following:
Claims may lack written description when the claims define the invention in functional language
specifying a desired result but the specification does not sufficiently describe how the function is
performed or the result is achieved. For software, this can occur when the algorithm or
steps/procedure for performing the computer function are not explained at all or are not
explained in sufficient detail (simply restating the function recited in the claim is not necessarily
sufficient). In other words, the algorithm or steps/procedure taken to perform the function must
be described with sufficient detail so that one of ordinary skill in the art would understand how
the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection
IV.”
Therefore, the claims with the limitation of “deconvolute the abdominal acoustic signal” are rejected under 112(a) for failing to meet the written description requirement.
Claim Rejections - 35 USC § 101
The human organism rejection of claim 9 is withdrawn in view of Applicant’s amendment.
The 101 rejection is maintained, as a new 103 rejection has been issued. See the updated 101 rejection below.
Claim Rejections - 35 USC § 103
A new 103 rejection has been issued below.
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: ferroelectric nanogenerator sensor in claims 1, 17, and 21.
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 the “ferroelectric nanogenerator sensor” in claim 1, 17, and 21, the specification recites “ferroelectric nanogenerator sensing units for detecting abdominal pressure waves” (¶76). The Examiner is interpreting the ferroelectric nanogenerator sensor to be sensors for detecting abdominal pressure waves.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA  35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA  35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For the limitation of “deconvolute the abdominal acoustic signal” in claim 12, this is a computer implemented functional limitation “source separation algorithm decomposes the abdominal acoustic signal” according to ¶56 of the disclosure. ¶56 of the specification fails to disclose how the machine learning algorithm is used to deconvolute the abdominal acoustic signal using at least one of the first mHR value and the second mHR value. MPEP 2161.01(I) states the following:
Claims may lack written description when the claims define the invention in functional language
specifying a desired result but the specification does not sufficiently describe how the function is
performed or the result is achieved. For software, this can occur when the algorithm or
steps/procedure for performing the computer function are not explained at all or are not
explained in sufficient detail (simply restating the function recited in the claim is not necessarily
sufficient). In other words, the algorithm or steps/procedure taken to perform the function must
be described with sufficient detail so that one of ordinary skill in the art would understand how
the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection
IV.”
Therefore, the claims with the limitation of “deconvolute the abdominal acoustic signal” are rejected under 112(a) for failing to meet the written description requirement.
Claims 1-14 and 16-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA  35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For the limitation of “identify a noise correction value” in claims 1 and 17, this is a computer implemented functional limitation “microcontroller is configured to…identify a noise correction value” according to ¶23 of the disclosure. ¶23 and ¶42 of the specification fail to disclose how the comparison creates a noise correction value. This limitation is a functional result without any steps indicating how the result is actually obtained. See MPEP 2161.01(I) above. Therefore, the claims with the limitation of “identify a noise correction value” are rejected under 112(a) for failing to meet the written description requirement. Dependent claims are rejected for the same deficiency set forth for independent claims 1 and 17.
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 and 16-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.
In claims 1, 17, and 21, the limitation of “a ferroelectric nanogenerator sensor that detects abdominal pressure waves” seems unclear. It remains unclear how the ferroelectric nanogenerator sensor contributes the fetal health monitoring, as the limitation only claims detecting abdominal pressure waves and is never incorporated further in the claim language.
In claims 1, 17, and 21, the limitation of “a ferroelectric nanogenerator sensor that detects abdominal pressure waves” and “a microelectromechanical system (MEMS) accelerometer that converts an acoustic wave sensed in an abdominal region into an abdominal acoustic signal” seem unclear. ¶78 of the specification recites:
In some embodiments, the method further comprises determining fetal ballistocardiography data from abdominal acoustic wave data obtained through inclinometer sensing units. In some embodiments, the method is for determining fetal phonocardiography data from abdominal acoustic wave data obtained through MEMS accelerometer sensing units. In some embodiments, the method is for determining fetal movement data from abdominal acoustic wave data obtained through MEMS accelerometer sensing units. In some embodiments, the method for determining fetal heartrate data from abdominal pressure wave data obtained through diaphragm or ferroelectric nanogenerator sensing units.
It remains unclear whether the MEMS accelerometer and the ferroelectric nanogenerator sensor sense the same waves or different waves. If it is the same wave, how do they work together to extract a fetal phonocardiogram value? It would appear that Applicant has alternative embodiments that use either a MEMS accelerometer OR a ferroelectric nanogenerator and not both.
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 1-14 and 16-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea (mathematical concept of “calculate a first maternal heart rate (mHR) value from the mPCG value and calculate a second mHR value from the mPPG value”  and mental process of “compare the first mHR value with the second mHR value to identify a noise correction value”) without significantly more.
Step 1
The claimed invention in claims 1-14 and 16-21 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 mathematical concepts 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 (I) and (III)).
Regarding claims 1, 17, and 21, the limitations of “calculate a first maternal heart rate (mHR) value from the mPCG value and calculate a second mHR value from the mPPG value” are mathematical calculations of calculating a maternal heart rates in order to apply a noise correct value to the fetal phonocardiogram.
Regarding claims 1, 17, and 21, the limitation of “compare the first mHR value with the second mHR value to identify a noise correction value” 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, these limitations are nothing more than a medical professional evaluating a noise correction value based on judgement between a first mHR value and a second mHR value.
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 “a microelectromechanical system (MEMS) accelerometer, a pulse oximeter, a microcontroller, and a ferroelectric nanogenerator sensor.” Claim 21 additionally recites “a processor.” The microelectromechanical system (MEMS) accelerometer, pulse oximeter, and ferroelectric nanogenerator sensor amount to nothing more than pre-solution activity of data gathering. The microcontroller and processor 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 a microelectromechanical system (MEMS) accelerometer, a pulse oximeter, and a ferroelectric nanogenerator sensor amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the MEMS accelerometer, pulse oximeter, and ferroelectric nanogenerator sensor are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20180092564 (¶59-MEMS accelerometer), US 20170281087 (¶21-pulse oximeter), NPL “Piezoelectricity in PVDF and PVDF Based Piezoelectric Nanogenerator: A Concept” (page 97, ¶2-nanogenerator; page 96, ¶1-ferroelectric), and US 20180336968 (¶28-ferroelectric sensor, ferroelectric film that converts mechanical pressure into electrical energy is attached onto the upper plate and the lower plate of the pressure detection unit 130) . 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 2-14, 16, and 18-20, the limitations of claims 1, 17, and 21 further define the limitations already indicated as being directed to the abstract idea.
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.
Claims 1-3, 7-9, 16-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Holt (WO 2019133926 filed on 12/28/18) in view of Bureev (RU 2656518 filed on 3/6/14), Meriheina (US 20180092564 filed on 10/2/17), and Bera (NPL “Piezoelectricity in PVDF and PVDF Based Piezoelectric Nanogenerator: A Concept” 2017).
Regarding claims 1, 17, and 21, Holt teaches a wearable fetal health monitoring device, a method, and a non-transitory computer-readable storage medium for determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus, the device comprising: a pulse oximeter that generates a maternal photoplethysmogram (mPPG) value from a pulse sensed in the abdominal region (¶6-maternal photoplethysmogram; ¶8-separated signal that corresponds to light incident upon the pregnant mammal (e.g., maternal photoplethysmogram); ¶73-pulse oximetry probe; ¶10-detected optical signal may correspond to an optical signal projected into the pregnant mammal’s abdomen by one or more light sources); at least one processor (¶10-processor; ¶56); calculate a second mHR value from the mPPG value (¶9-secondary signal (e.g. maternal heart rate); ¶8): and compare the first mHR value with the second mHR value to identify a noise correction value (¶75-the maternal heartrate signal may be used to determine which portions of the signals received in step 305 are contributed by the pregnant mammal. These portions may then be subtracted and/or divided from the signals received in step 305 to remove maternal contributions to the signals received in step 305). However, Holt does not teach a microelectromechanical system (MEMS) accelerometer that converts an acoustic wave sensed in an abdominal region into an abdominal acoustic signal; a ferroelectric nanogenerator sensor that detects abdominal pressure waves; and a microcontroller configured to: generate a maternal phonocardiogram (mPCG) value from the abdominal acoustic signal; calculate a first maternal heart rate (mHR) value from the mPCG; and apply the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG).
Bureev relates generally to medicine and obstetrics, in particular to medical diagnostics and can be used for mobile monitoring, and monitoring and evaluating the state of the fetus and method (page 4, top of page). Bureev more particularly relates to evaluating with maximum accuracy, the state of the fetus and mother, having a higher quality of registered signals, and increasing reliability and diagnostic value of produced data (page 9, middle of the page). Bureev further teaches the invention using the following steps:
generate a maternal phonocardiogram (mPCG) value from the abdominal acoustic signal (page 6, ¶2-placement on upper and lower part of abdomen of pregnant women, heart tones mother); calculate a first maternal heart rate (mHR) value from the mPCG value (bottom of page 8-heart rate mother); apply the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG) value (claim 1-attenuation of external noise and interference before subtracting of registered tones of fetus heart).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include generating a maternal phonocardiogram, a first maternal heart rate, and fetal phonocardiogram of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Meriheina relates generally to monitoring of heartbeats, particularly to monitoring of fetus and infant heartbeats with ballistocardiographic measurements. The present disclosure further relates to an analysis method and an apparatus which allow the weak ballistocardiographic signals caused by infant and fetus heartbeats to be distinguished from more dominant signal components, such as an adult's heartbeat (¶1). Meriheina further teaches a MEMS accelerometer (¶59). Meriheina further teaches the invention using the following steps:
a microelectromechanical system (MEMS) accelerometer that converts an acoustic wave sensed in an abdominal region into an abdominal acoustic signal (¶59-MEMS accelerometer); and a microcontroller (¶57-control unit 26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the MEMS accelerometer and microcontroller of Meriheina of the invention in Holt in order to allow the weak ballistocardiographic signals caused by infant and fetus heartbeats to be distinguished from more dominant signal components, such as an adult's heartbeat (Meriheina, ¶1).
Bera relates generally to PVDF which is a ferroelectric polymer, exhibiting efficient piezoelectric and pyroelectric properties. These characteristics make it useful in sensor and battery applications (page 96, ¶1). Bera additionally relates to a nanogenerator which is a type of technology that converts mechanical/thermal energy as produced by small-scale physical change into electricity (page 97, ¶2) Bera further teaches the invention using the following step:
a ferroelectric nanogenerator sensor that detects abdominal pressure waves (page 97, ¶2-3-nanogenerator; page 96, ¶1-ferroelectric; page 98, ¶3-pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date that the claimed invention include a ferroelectric nanogenerator sensor that detects abdominal pressure waves of Bera of the invention of Holt because the nanogenerator is expected to be applied for various applications where the periodic kinetic energy exists, such as the muscle movement by the beat of a heart (page 97, ¶2).
Regarding claim 2, Holt teaches a power source operatively coupled to a wireless transceiver (¶25-wireless, power).
Regarding claims 3 and 18, Holt in view of Bureev, Meriheina, and Bera teaches the device and the method of claims 1 and 17. However, Holt does not teach to calculate from the fPCG value at least one of: a fetal heart rate (fHR) value and a fetal heart rate variability (fHRV) value.
Bureev teaches calculating from the fPCG value at least one of: a fetal heart rate (fHR) value (bottom of page 8-heart rate of fetus) and a fetal heart rate variability (fHRV) value (top of page 9-cardiac rhythm variability of fetus).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include calculating from the fPCG value at least one of: a fetal heart rate (fHR) value and a fetal heart rate variability (fHRV) value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Regarding claim 7, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach calculating a maternal activity level from at least one of the mPPG value and the first mHR value and the second mHR value.
Bureev teaches wherein the microcontroller is further configured to calculate a maternal activity level from at least one of the mPPG value and the first mHR value and the second mHR value (page 5, middle of page-electrical activity of heart mother; bottom of page 8-heart rate mother).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include calculating a maternal activity level from at least one of the mPPG value and the first mHR value and the second mHR value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Regarding claim 8, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope.
Meriheina teaches one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope (¶35-gyroscope; ¶23).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope of Meriheina of the invention in Holt in order to allow the weak ballistocardiographic signals caused by infant and fetus heartbeats to be distinguished from more dominant signal components, such as an adult's heartbeat (Meriheina, ¶1).
Regarding claim 9, Holt teaches a patch that removably attaches to a maternal torso (¶46- an adhesive designed to be applied to the skin of the pregnant mammal’s abdomen (e.g., glue, tape, etc.) configured to apply housing 102/fetal hemoglobin probe 115 directly to the skin of the pregnant mammal’s abdomen and hold it in place there in a manner similar to a sticker).
Regarding claim 16, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach 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.
Bureev teaches 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 (claim 1-attentuation of external noise and interference; page 7, middle of page-combined in one housing with complex acoustic sensors 1 and 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date that the claimed invention include 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 of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Regarding claim 19, Holt in view of Bureev, Meriheina, and Bera teaches the method of claim 17. However, Holt does not teach outputting at least one of a normal state, caution state, and emergency state based on the extracted fetal phonocardiogram (fPCG) value.
Bureev teaches outputting at least one of a normal state, caution state, and emergency state based on the extracted fetal phonocardiogram (fPCG) value (page 5, top of page- monitoring the fast changes of the state of the fetus; page 8, ¶2-emergency mode; page 6, ¶2-tones of the fetus heart; page 7, middle of page-digital or an analog output, is intended for recording tones of fetus heart).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date that the claimed invention include outputting at least one of a normal state, caution state, and emergency state based on the extracted fetal phonocardiogram (fPCG) value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Igney (US 20100305481 filed on 5/7/08).
Regarding claims 4 and 20, Holt in view of Bureev, Meriheina, and Bera teaches the device and the method of claims 1 and 17. However, Holt does not teach calculating a fetal movement (fM) value from the abdominal acoustic signal.
Igney teaches calculating a fetal movement (fM) value from the abdominal acoustic signal (¶17-movements of the fetus)
Igney relates to a system and method for automatically monitoring the movement activity of a fetus (¶1). Igney additionally teaches an easy and completely unobtrusive way of monitoring the movement activity of an unborn child. With the present invention the evaluation and monitoring of child movements can be carried out completely automatically in a home environment (¶16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include calculating a fetal movement (fM) value from the abdominal acoustic signal of Igney of the invention in Holt in order to provide an easy and completely unobtrusive way of monitoring the movement activity of an unborn child. With the present invention the evaluation and monitoring of child movements can be carried out completely automatically in a home environment (Igney, ¶16).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Venugopalan (US 20170049414 filed on 5/22/15), hereinafter referred to as Ven.
Regarding claim 5, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach wherein the pulse oximeter is further configured to sense a maternal peripheral capillary oxygen saturation (mSpO2) value.
Venugopalan teaches wherein the pulse oximeter is further configured to sense a maternal peripheral capillary oxygen saturation (mSpO2) value (¶35-maternal pulse oximetry (SpO2); ¶43).
Ven relates generally to providing wireless sensor. More specifically the subject matter relates to a wireless sensor capable of communicating with a remote ultrasound processing system for managing fetal and maternal data (¶1). Ven also relates to the fetal and maternal data being examined by a medical practitioner to determine the health status of the fetus and the subject (¶6). Ven further teaches the maternal pulse oximetry (SpO2) (¶35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the mSpO2 value of Ven of the invention in Holt in order to provide a wireless fetal sensor and system for managing fetal data and maternal data of a subject, so that the fetal and maternal data can be examined by a medical practitioner to determine the health status of the fetus and the subject (Ven, ¶6).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Stahmann (US 7787946 filed on 9/1/04).
Regarding claim 6, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor.
Stahmann teaches wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor (col. 238 and lines 19-28-accelerometer based acoustic sensors, MEMS-based acoustic sensors).
Stahmann relates generally to systems and methods providing patient monitoring, diagnosis and/or therapy (Field of the Invention section). Stahmann further teaches one or more functions of two or more individual medical procedures may be used in combination to enhance patient monitoring, diagnosis and/or therapy (col. 2 and lines 52-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor of Stahmann of the invention in Holt in order for one or more functions of two or more individual medical procedures may be used in combination to enhance patient monitoring, diagnosis and/or therapy (Stahmann, col. 2 and lines 52-54).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Workman (US 20170281087 as cited in the IDS and filed on 3/31/17).
Regarding claim 10, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach wherein the device comprises two units spaced apart from each other, wherein the two units are carried on a belt or band that surrounds a maternal torso.
Workman teaches wherein the device comprises two units spaced apart from each other, wherein the two units are carried on a belt or band that surrounds a maternal torso (¶20-the belly-covering garment 140 may comprise a belt or a stray that is capable of holding the sensor modules sensor modules 120(a-d) adjacent to the belly 100; Fig. 1).
Workman relates generally to a system for monitoring fetal health data and/or mother health data. Workman further teaches a belly-covering garment that is configured to at least partially cover a belly and to hold one or more sensor modules directly adjacent to the belly (¶5). Workman additionally teaches determining whether the fetus is within the first region or the second region based upon readings received from the first sensor module and the second sensor module (¶7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include wherein the device comprises two units spaced apart from each other, wherein the two units are carried on a belt or band that surrounds a maternal torso of Workman of the invention in Holt in order to determine whether the fetus is within the first region or the second region based upon readings received from the first sensor module and the second sensor module (Workman, ¶7).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Zia (US 20140180153 filed on 12/23/13).
Regarding claim 11, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach an acoustic impedance matching housing.
Zia teaches wherein the device further comprises an acoustic impedance matching housing (¶32-acoustically impedance matched, housing).
Zia relates generally to medical diagnostic systems, and more particularly, to a system and method for acoustic detection of coronary artery disease and automated editing of heart sound data (¶3). Zia also teaches systems and methods for adaptively canceling noise in an acoustic heart signal and/or automatically editing heart sound data (¶10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include an acoustic impedance matching housing of Zia of the invention of Holt in order for adaptively canceling noise in an acoustic heart signal and/or automatically editing heart sound data (Zia, ¶10).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Chen (WO 2018148251 filed on 2/7/18).
Regarding claim 12, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach wherein the microcontroller is further configured to deconvolute the abdominal acoustic signal using at least one of the first mHR value and the second mHR value.
Bureev the abdominal acoustic signal (page 6, ¶2-placement on upper and lower part of abdomen of pregnant women, heart tones mother) using the first mHR value (bottom of page 8-heart rate mother).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the abdominal acoustic signal and using the first mHR value of Bureev of the invention in Holt in order to evaluate with maximum accuracy the state of the fetus and mother, have higher quality of registered signals, and increase reliability and diagnostic value of produced data (Bureev, page 9, middle of the page).
Chen teaches wherein the microcontroller is further configured to deconvolute (¶98-deconvoluting mixed signals with respect to the identified sources, heart sound).
Chen relates generally to a methodology is disclosed that enables calculation of the systolic and diastolic blood pressures continuously in a non-invasive manner, based on the heart sounds measured from the chest of a human being (¶47). Chen also teaches deconvoluting mixed signals (¶98).  Chen also teaches analyzing acoustic signals, locating and separating noise sources via multi-channel microphones as an effective approach for both airborne and structural-born noise problems (¶99).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include the deconvolution of Chen of the invention in Holt in order analyze acoustic signals, locate and separate noise sources via multi-channel microphones as an effective approach for both airborne and structural-born noise problems (Chen, ¶99).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Ransbury (US 20180317789 filed on 5/2/18).
Regarding claim 13, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach an inclinometer sensor that detects a sub- audible abdominal acoustic wave.
Ransbury teaches an inclinometer sensor that detects a sub-audible abdominal acoustic wave (¶37-inclinometer; ¶30-acoustic waveforms; ¶31-sub-audile frequencies).
Ransbury relates generally to methods and systems for remote monitoring of heart activity (¶2). Ransbury more particularly relates to a wearable heart monitoring device for monitoring heart activity comprising one or more acoustic sensors, including at least one microphone configured to operate in a frequency range related to human hearing, and at least one accelerometer configured to operate in the range of low or sub-audible frequencies (¶4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include an inclinometer sensor that detects a sub- audible abdominal acoustic wave of Ransbury of the invention in Holt in order to operate in the range of low or sub-audible frequencies and analyzing the data collected by the one or more sensors to determine a condition of a heart (Ransbury, ¶9).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Bureev, Meriheina, and Bera as applied to claims 1-3, 7-9, and 16-19 above, and further in view of Khine (US 20170086709 A1 as cited in the IDS and filed on 5/18/15).
Regarding claim 14, Holt in view of Bureev, Meriheina, and Bera teaches the device of claim 1. However, Holt does not teach wherein a first portion of the device is disposable, and wherein a second portion of the device is re-usable.
Khine teaches wherein a first portion of the device is disposable, and wherein a second portion of the device is re-usable (¶70-a disposable patient interface; ¶95-reusable component).
Khine relates generally to a wearable sensor for monitoring fetal movement (e.g., fetal kicks) and/or health. The disclosure relates to technology for monitoring fetal health during later stages (e.g., weeks 24+) of pregnancy. More specifically, a sensor can be worn by a mother to extract biometric data about the fetus. This data can be used as an indirect indicator of fetal health (¶9). Khine further teaches that this wearable sensor is less cumbersome then existing technology to improve user compliance. With continuous monitoring a decline in fetal movement can be detected earlier then without this device (¶10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date that the claimed invention include wherein a first portion of the device is disposable, and wherein a second portion of the device is re-usable of Khine of the invention in Holt in order to improve user compliance and with continuous monitoring a decline in fetal movement can be detected earlier then without this device (Khine, ¶10).
Conclusion

CITED REFERENCE SUMMARIES: Ref US20180092564A1: Claims:
A method for monitoring the heart rate of a test subject, comprising: placing an acceleration sensor in contact with a recoil surface which is in contact with the test subject, measuring a sensor output signal in multiple time intervals, calculating from the sensor output signal measured in a time interval an indicator of the average heart rate of the test subject in said time interval, and outputting the indicator for monitoring, wherein the calculation includes: identifying in the time domain characteristic frequencies of dominant periodic components in the sensor output signal during the time interval, transforming the output signal to the frequency domain across the time interval, screening the characteristic frequencies of dominant periodic components in the frequency domain, and calculating the indicator from the data which remains in the frequency domain after screening.
placing an acceleration sensor in contact with a recoil surface which is in contact with the test subject,
measuring a sensor output signal in multiple time intervals,
calculating from the sensor output signal measured in a time interval an indicator of the average heart rate of the test subject in said time interval, and
outputting the indicator for monitoring,
wherein the calculation includes:
identifying in the time domain characteristic frequencies of dominant periodic components in the sensor output signal during the time interval,
transforming the output signal to the frequency domain across the time interval,
screening the characteristic frequencies of dominant periodic components in the frequency domain, and
calculating the indicator from the data which remains in the frequency domain after screening.
A method according to claim 1 , wherein the recoil surface is flat, and that the test subject is lying on the recoil surface when the measurement is performed.
A method according to claim 1 , wherein the recoil surface is the outside of a belly, and that the test subject is inside the belly when the measurement is performed.
A method according to claim 1 , wherein the sensor is a 2-axis acceleration sensor.
A method according to claim 1 , wherein the indicator is calculated as a weighted average of one or more indicators calculated in earlier time intervals, and an average heart rate estimate calculated in a present time interval.
one or more indicators calculated in earlier time intervals, and
an average heart rate estimate calculated in a present time interval.
A monitoring system for monitoring the heartbeat of a test subject, the monitoring system comprising: an acceleration sensor configured to be held in contact with a recoil surface which is in contact with the test subject, a control unit connected to the acceleration sensor to receive a sensor output signal in a time interval, and configured to calculate an indicator of the average heart rate of the test subject in the time interval, an interface unit connected to the control unit and configured to output the indicator for monitoring, wherein the control unit is configured to calculate the indicator by: identifying in the time domain characteristic frequencies of dominant periodic components in the sensor output signal during the time interval, transforming the sensor output signal to the frequency domain across the time interval, screening the characteristic frequencies of dominant periodic components in the frequency domain, and calculating the indicator from the data which remains in the frequency domain after screening.
an acceleration sensor configured to be held in contact with a recoil surface which is in contact with the test subject,
a control unit connected to the acceleration sensor to receive a sensor output signal in a time interval, and configured to calculate an indicator of the average heart rate of the test subject in the time interval,
an interface unit connected to the control unit and configured to output the indicator for monitoring,
wherein the control unit is configured to calculate the indicator by:
transforming the sensor output signal to the frequency domain across the time interval,
A monitoring system according to claim 6 , wherein the recoil surface is a flat surface on which a test subject can lie.
A monitoring system according to claim 6 , wherein the surface is the outside of a belly, with the test subject inside.
A monitoring system according to claim 6 , wherein the sensor is a 2-axis acceleration sensor.
A monitoring system according to claim 6 , wherein the control unit is configured to calculate indicator as a weighted average of one or more indicators calculated in earlier time intervals, and an average heart rate estimate calculated in the present time interval.
an average heart rate estimate calculated in the present time interval.
Ref US20170049414A1: Claims:
A sensor of a maternal and fetal monitoring device, the sensor comprising: a signal processor configured to: transmit ultrasound beam on to a portion of a subject; receive reflected ultrasound signals from the subject; and process the reflected ultrasound signals to generate at least one of processed fetal maternal information and processed maternal information; and a wireless module configured to communicate with a remote ultrasound processing system, wherein the wireless module streams at least one of the processed fetal maternal information and the processed maternal information to be stored in the remote ultrasound processing system.
a signal processor configured to: transmit ultrasound beam on to a portion of a subject; receive reflected ultrasound signals from the subject; and process the reflected ultrasound signals to generate at least one of processed fetal maternal information and processed maternal information; and
transmit ultrasound beam on to a portion of a subject;
receive reflected ultrasound signals from the subject; and
process the reflected ultrasound signals to generate at least one of processed fetal maternal information and processed maternal information; and
a wireless module configured to communicate with a remote ultrasound processing system, wherein the wireless module streams at least one of the processed fetal maternal information and the processed maternal information to be stored in the remote ultrasound processing system.
The sensor of claim 1 , wherein the remote ultrasound processing system is configured to process at least one of the processed fetal information and the processed maternal information to generate at least one of fetal data and maternal data respectively of the subject.
The sensor of claim 1 further comprises a data processor configured to process at least one of the processed fetal information and the processed maternal information to generate at least one of fetal data and maternal data respectively of the subject.
The sensor of claim 3 , wherein the wireless module is further configured to stream at least one of the processed fetal information and the processed maternal information to the remote ultrasound processing system for storage.
The sensor of claim 1 , wherein the remote ultrasound processing system is a cloud based system.
The sensor of claim 1 further comprises a position identifying module configured to locate positional information associated with the sensor.
A system for managing at least one of fetal data and maternal data of a subject, wherein the system comprises: at least one sensor, wherein a sensor of the at least one sensor comprises: a signal processor configured to: transmit ultrasound beam on to a portion of a subject; receive reflected ultrasound signals from the subject; and process the reflected ultrasound signals to generate at least one of processed fetal information and processed maternal information; and a wireless module configured to stream at least one of the processed fetal information and processed maternal information; and a remote ultrasound processing system configured to wirelessly communicate with the at least one sensor, wherein the remote ultrasound processing system is configured to receive at least one of the processed fetal information the processed maternal information for storage.
at least one sensor, wherein a sensor of the at least one sensor comprises: a signal processor configured to: transmit ultrasound beam on to a portion of a subject; receive reflected ultrasound signals from the subject; and process the reflected ultrasound signals to generate at least one of processed fetal information and processed maternal information; and a wireless module configured to stream at least one of the processed fetal information and processed maternal information; and
a signal processor configured to: transmit ultrasound beam on to a portion of a subject; receive reflected ultrasound signals from the subject; and process the reflected ultrasound signals to generate at least one of processed fetal information and processed maternal information; and
process the reflected ultrasound signals to generate at least one of processed fetal information and processed maternal information; and
a wireless module configured to stream at least one of the processed fetal information and processed maternal information; and
a remote ultrasound processing system configured to wirelessly communicate with the at least one sensor, wherein the remote ultrasound processing system is configured to receive at least one of the processed fetal information the processed maternal information for storage.
The system of claim 7 , wherein the sensor further comprises a data processor configured to process at least one of the processed fetal information and the processed maternal information to generate at least one of fetal data and maternal data respectively of the subject.
The system of claim 8 , wherein the wireless module is further configured to stream at least one of the fetal data and the maternal data to the remote ultrasound processing system.
The system of claim 8 , wherein the wireless module is further configured to stream the processed fetal information and the processed maternal information to the remote ultrasound processing system.
The system of claim 7 , wherein the remote ultrasound processing system is configured to process at least one of the processed fetal information and the processed maternal information to generate at least one of fetal data and maternal data respectively of the subject.
The system of claim 7 , wherein the remote ultrasound processing system is configured to communicate with a plurality of user devices, wherein a user device of the plurality of user devices is capable of presenting at least one of the fetal data and the maternal data to a user.
The system of claim 7 , wherein the remote ultrasound processing system is a cloud based system.
The system of claim 7 further comprises a data processing subsystem configured to: receive at least one of the processed fetal information and processed maternal information from the signal processor; and process the processed fetal information and processed maternal information to generate at least one of the fetal data and the maternal data respectively.
receive at least one of the processed fetal information and processed maternal information from the signal processor; and
process the processed fetal information and processed maternal information to generate at least one of the fetal data and the maternal data respectively.
The system of claim 14 , wherein the data processing subsystem is configured to transmit at least one of the processed fetal information and processed maternal information to the remote ultrasound processing system for storage.
A method of managing at least one of fetal data and maternal data of a subject, the method comprising: transmitting ultrasound beam on to a portion of a subject using a sensor; receiving reflected ultrasound signals from the subject by the sensor; processing the reflected ultrasound signals to generate at least one of processed fetal information and processed maternal information; and streaming at least one of the processed fetal information and the processed maternal information to a remote ultrasound processing system wirelessly communicable to the sensor, wherein the remote ultrasound processing system stores the processed fetal information.
transmitting ultrasound beam on to a portion of a subject using a sensor;
receiving reflected ultrasound signals from the subject by the sensor;
processing the reflected ultrasound signals to generate at least one of processed fetal information and processed maternal information; and
streaming at least one of the processed fetal information and the processed maternal information to a remote ultrasound processing system wirelessly communicable to the sensor, wherein the remote ultrasound processing system stores the processed fetal information.
The method of claim 16 further comprises processing at least one of the processed fetal information and the processed maternal information to generate at least one of the fetal data and the maternal data respectively of the subject by the remote ultrasound processing system.
The method of claim 16 further comprises streaming at least one of the fetal data and the maternal data to the remote ultrasound processing system for storage.
The method of claim 16 further comprises locating positional information associated with the sensor.
The method of claim 16 further comprises facilitating communication between the remote ultrasound processing system and a plurality of computing devices, wherein a computing device of the plurality of computing devices is capable of presenting the at least one of the fetal data and the maternal data to a user.
Ref US20100305481A1: [content unavailable]
Ref US20180317789A1: Claims:
A wearable heart monitoring device comprising: one or more acoustic sensors, including at least one microphone configured to operate in a frequency range related to human hearing; and at least one accelerometer configured to operate in the range of low or sub-audible frequencies.
one or more acoustic sensors, including at least one microphone configured to operate in a frequency range related to human hearing; and at least one accelerometer configured to operate in the range of low or sub-audible frequencies.
at least one microphone configured to operate in a frequency range related to human hearing; and
at least one accelerometer configured to operate in the range of low or sub-audible frequencies.
The wearable heart monitoring device of claim 1 , further comprising a processor in communication with the one or more acoustic sensors, the processor being configured to analyze data collected by the one or more sensors to determine a condition of a heart.
The wearable heart monitoring device of claim 2 , wherein analyzing the collected data includes noise reduction and location of clinically standard heart sounds using peak detection and frequency analysis.
The wearable heart monitoring device of claim 2 , wherein the processor is positioned within the wearable heart monitoring device.
The wearable heart monitoring device of claim 2 , wherein the processor is remote form the heart monitoring device and is configured to communicate with the one or more acoustic sensors using a wireless connection.
The wearable heart monitoring device of claim 2 , wherein the processor is configured to sample data from the one or more acoustic sensors at a rate of 12 to 24-bits per sample.
The wearable heart monitoring device of claim 1 , further comprising one or more data acquisition components configured to supplement the acoustic data collected by the one or more acoustic sensors with additional data relating to the heart.
The wearable heart monitoring device of claim 6 , wherein one of the one or more data acquisition components is one or more EKG electrodes.
The wearable heart monitoring device of claim 7 , wherein the one or more EKG electrodes are configured to collect EKG vectors to produce at least one EKG signal that can be analyzed for heart rate, R-wave detection, heart-rate variability, or the presence of arrhythmia.
The wearable heart monitoring device of claim 6 , wherein one of the one or more data acquisition components is at least one gyroscope configured to determine an orientation of the heart monitoring device in space.
The wearable heart monitoring device of claim 8 , wherein the gyroscope is configured to account for changes in blood flow through the heart relating to gravity as a body moves through space.
The wearable heart monitoring device of claim 8 , wherein the gyroscope utilizes as least three axes to determine orientation of the heart monitoring device.
The wearable heart monitoring device of claim 1 , further comprising a sensor recharger configured to refresh the acoustic sensor using wired or wireless communication.
The wearable heart monitoring device of claim 1 , wherein the at least one microphone is configured to operate in the range between about 4 KHz and about 1 KHz.
The wearable heart monitoring device of claim 14 , wherein the at least on accelerometer is configured to operate in the range between about 1 KHz and about 0.5 Hz.
A wearable heart monitoring device comprising: one or more acoustic sensors, including at least one microphone configured to operate in a frequency range related to human hearing; and at least one accelerometer configured to operate in the range of low or sub-audible frequencies; and at least one gyroscope configured to determine an orientation of the heart monitoring device in space, wherein data collected by the one or more acoustic sensors and the at least one gyroscope is analyzed to determine a condition of a heart of a patient wearing the heart monitoring device.
one or more acoustic sensors, including at least one microphone configured to operate in a frequency range related to human hearing; and at least one accelerometer configured to operate in the range of low or sub-audible frequencies; and
at least one accelerometer configured to operate in the range of low or sub-audible frequencies; and
at least one gyroscope configured to determine an orientation of the heart monitoring device in space,
wherein data collected by the one or more acoustic sensors and the at least one gyroscope is analyzed to determine a condition of a heart of a patient wearing the heart monitoring device.
The wearable heart monitoring device of claim 16 , further comprising one or more data acquisition components configured to supplement the acoustic data collected by the one or more acoustic sensors with additional data relating to the heart.
The wearable heart monitoring device of claim 16 , wherein one of the one or more data acquisition components is one or more EKG electrodes.
A method for monitoring heart activity, comprising: collecting acoustic data using one or more acoustic sensors, the one or more acoustic sensors including at least one microphone configured to operate in a frequency range related to human hearing and at least one accelerometer configured to operate in the range of low or sub-audible frequencies; and analyzing data collected by the one or more sensors to determine a condition of a heart using a processor.
collecting acoustic data using one or more acoustic sensors, the one or more acoustic sensors including at least one microphone configured to operate in a frequency range related to human hearing and at least one accelerometer configured to operate in the range of low or sub-audible frequencies; and
analyzing data collected by the one or more sensors to determine a condition of a heart using a processor.
The method of claim 19 , wherein analyzing the collected data includes noise reduction and location of clinically standard heart sounds using peak detection and frequency analysis.
Ref US20140180153A1: [content unavailable]
Ref US7787946B2: [content unavailable]
Ref WO2019133926A1: Claims:
A method comprising:
receiving, by a processor, a
[Truncated to input limit]