Office Action 2: Non-Final Rejection (2023-09-15)
Rejection types: 101 - Patent-Eligible Subject Matter, 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
AMENDMENTS TO THE CLAIMS

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

Listing of Claims

1\. (Currently Amended) A wearable fetal health monitoring device for determining a 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.

2\. (Original) 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\. (Original) 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\. (Original) The device of claim 1, wherein the microcontroller is further configured to calculate a fetal movement (fM) value from the abdominal acoustic signal.
5\. (Original) The device of claim 1, wherein the pulse oximeter is further configured to sense a maternal peripheral capillary oxygen saturation (mSpO2) value.

6\. (Original) The device of claim 1, wherein the MEMS accelerometer comprises at least one of an acoustic wave sensor and a pressure wave sensor.
7\. (Original) 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\. (Original) The device of claim 1, further comprising one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope.
9\. (Currently Amended) The device of claim 1, further comprising a patch configured to removably attach to a maternal torso.

10\. (Original) 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\. (Original) The device of claim 1, wherein the device further comprises an acoustic impedance matching housing.

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

14\. (Original) 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\. (Canceled)

16\. (Original) 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\. (Currently Amended) 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;
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.

18\. (Original) 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\. (Original) 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\. (Original) The method of claim 17, further comprising calculating a fetal movement (fM) value from the abdominal acoustic signal.

21\. (New) A non-transitory computer-readable storage medium, the non-transitory computer-readable storage medium storing instructions to be implemented on a wearable fetal health monitoring device comprising: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
at least one processor;
the instructions when executed by the at least one processor cause wearable fetal health monitoring device to perform a method of determining a heath condition of a fetus based on biosignals of an expecting mother and the fetus, the method comprising: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; and
applying the identified noise correction value to the mPCG value to extract a fetal phonocardiogram (fPCG) value.

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

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, 4-9, 11, 13-14, 16-17, and 19-25 are rejected. Claims 2-3, 10, 12, 15, and 18 are canceled.
Response to Arguments
Claim Rejections - 35 USC § 112
The previous 112 rejections have been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 1/12/24 have been fully considered but they are not persuasive. Applicant argues that amended claim 1 recites additional limitations the reflect an improvement of a technical field (e.g., determining a health condition of a fetus based on biosignals of an expecting mother and the fetus) (Remarks, page 25). However, the Examiner disagrees. The claim amounts to nothing more than the abstract idea itself as recited in the rejection below. Applicant is encouraged to amend further details for the limitation “determining fetal heart rate variability” to show that it is too complex to be performed in the human mind. For instance, how many data points are used?
Applicant argues that the additional elements recited in the present claims amount to significantly more than the judicial exception (Remarks, page 29). However, the Examiner disagrees. The Examiner has provided references to show that the additional elements are well-understood, routine, and conventional structures in the rejection below.
The 101 rejection is maintained and has been updated to reflect the amendments.
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to claims 1, 4-9, 11, 13-14, 16-17, and 19-25 have been considered but are moot in view of the new ground of rejections.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter.  See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).  Correction of the following is required:
“reduced power mode” in claims 1, 17, and 21; and
“a passive sensor” in claims 1, 17, and 21.
Claim Objections
Claim 17 is objected to because of the following informalities: “heath” should read –health--.  Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA  35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.  The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph:
(A)	the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B)	the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C)	the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.  Such claim limitation(s) is/are:
a securing device in claims 1, 17, and 21
noise attenuator in claim 16
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For “securing device” in claims 1, 7, and 21, the specification recites a belt or adhesive patch (¶28). Therefore, the Examiner is interpreting the securing device to be a belt or adhesive patch.
For “noise attenuator” in claim 16, the specification recites “the noise attenuator comprises at least one of: circuitry including an amplifier, a signal processor, or a general - purpose processor” (¶76). The Examiner is interpreting the noise attenuator to be an amplifier, a signal processor, or a general purpose processor.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, applicant may:  (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 22 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 “Hidden Semi-Markov Model (HSMM)” in claim 22, this is a computer implemented functional limitation “after smoothing and spike removal, peaks are segmented using a duration-dependent hidden Semi-Markov Model (DD-HSMM) into relevant cardiac states, first heart sound (S1), second heart sound (S2), systolic silence, and diastolic silence” according to ¶57 of the disclosure. ¶57 of the specification fails to disclose how the machine learning algorithm is used to determine fHRV. 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.”
Applicant has claimed a black-box algorithm without any clear description of what is inside the box to determine fHRV. This is a functional result and the description is lacking information, for instance, how is the model trained, what are the inputs to the model, what is the order of the inputs into the model, and how are the weights determined for the model? Therefore, the claims with the limitation of “Hidden Semi-Markov Model (HSMM)” are rejected under 112(a) for failing to meet the written description requirement.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-9, 11, 13-14, 16-17, and 19-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea (mental process of “determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data” and certain methods of organizing human activity of “providing an alert to the expecting mother based on the fHRV data”) without significantly more.
Step 1
The claimed invention in claims 1, 4-9, 11, 13-14, 16-17, 19-25 are directed to statutory subject matter as the claims recite a wearable fetal health monitoring device, a method, and a non-transitory computer-readable storage medium for determining a health condition of a fetus based on biosignals of an expecting mother and the fetus.
Step 2A, Prong One
Regarding claims 1, 17, and 21, the recited steps are directed to certain methods of organizing human activity and a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (II) and (III)).
Regarding claims 1, 17, and 21, the limitation of “providing an alert to the expecting mother based on the fHRV data” is a process, as drafted, covers performance of the limitation that is directed to organizing human activity (managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions). For example, this limitation is nothing more than a medical professional verbally communicating the result to the mother.
Regarding claims 1, 17, and 21, the limitation of “determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional receiving a print out of fPCG data and making an evaluating of the fHRV based off of the data.
Step 2A, Prong Two
For claims 1, 17, and 21, the judicial exception is not integrated into a practical application. In particular, claims 1, 17, and 21 recite “a passive sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from a first location on a maternal torso, an optical sensor  configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso, a securing device configured to provide skin contact of the passive sensor and the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring, a microcontroller/processor for monitoring fetal movement (fM) using the passive sensor while operating in a first mode, upon detecting reduced fM activity, transitioning to a second mode comprising: decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data, and extract mechano-acoustically sensed fetal phonocardiogram (fPCG) data.” The passive sensor, optical sensor, securing device, decomposing step, and extracting step amount to nothing more than pre-solution activity of data gathering. The microcontroller/processor and mode transitioning step are recited at a high-level of generality and amount to nothing more than a part of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional elements of a passive sensor, an optical sensor, a securing device, decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data, and extracting mechano-acoustically sensed fetal phonocardiogram (fPCG) data amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the passive sensor, optical sensor, securing device, decomposing step, and extracting step are recited at a high level of generality and are well-understood, routine, and conventional activities as evidenced by WO 2019133926 (¶6; ¶73), NPL “Validation of beat by beat fetal heart signals acquired from four-channel fetal phonocardiogram with fetal electrocardiogram in healthy late pregnancy” (page 3, Phonogram Signal recording section; Figs. 1-2; page 5, last ¶; Fig. 5), NPL “An IoT Based Multi-Parameter Data Acquisition System for Efficient Bio-Telemonitoring of Pregnant Women at Home” (page 619, section 4), US 20180000405 (¶101), and US 20180108440 (¶54-55; ¶59; ¶80). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). In this case, elements of general computer are being used to implement the abstract idea.
Regarding dependent claims 4-9, 11, 13-14, 16, 19-20, and 22-25, 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, 4, 7-9, 17, 20-21, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Queyam (NPL “An IoT Based Multi-Parameter Data Acquisition System for Efficient Bio-Telemonitoring of Pregnant Women at Home” published in 2018) in view of Holt (WO 2019133926 filed on 12/28/18), Khandoker (NPL “Validation of beat by beat fetal heart signals acquired from four-channel fetal phonocardiogram with fetal electrocardiogram in healthy late pregnancy published in 2018), and Hayes (WO 2014162135 filed on 4/2/14).
Regarding claims 1, 17, and 21, Queyam 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 passive sensor configured to provide mechano-acoustically sensed phonocardiogram (aPCG) data from a first location on a maternal torso (page 619, section 4-doppler ultrasound transducer as shown in Fig. 2(D) was placed on the mother's chest for maternal heart sound acquisition. When this transducer was placed on mother's abdomen at a location just above the fetal heart, then it captures maternal heart activity along with fetal heart activity); a securing device configured to provide skin contact of the passive sensor and the optical sensor to the maternal torso for continuous non-invasive non-clinical monitoring (page 619, Data Acquisition section-several non-invasive medical grade transducers attached to the mother's body for acquiring various maternal and fetal bio-physiological parameter like respiration rate, body temperature, photoplethysmogram (PPG), phonocardiogram (PCG), abdominal electrocardiogram (AECG) and fetal movements); and a microcontroller configured for: monitoring fetal movement (fM) using the passive sensor while operating in a first mode (page 620, Fetal Movement section-detection of the fetal movements), wherein the first mode is a reduced power mode (page 620, Fetal Movement section-detection of the fetal movements).
However, Queyam does not teach an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso; and upon detecting reduced fM activity, transitioning to a second mode comprising: decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data to extract mechano-acoustically sensed fetal phonocardiogram (fPCG) data; determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data; and providing an alert to the expecting mother based on the fHRV data.
Holt relates generally to the field of medical devices and, more particularly, in the field of trans-abdominal fetal oximetry and trans-abdominal fetal pulse oximetry (¶2). Holt further teaches the invention using the following step:
an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso (¶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).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Queyam to include an optical sensor configured to provide optically sensed maternal photoplethysmogram (mPPG) data from a second location on the maternal torso of Holt in order to assess the health of a fetus (e.g., a level of hypoxia or fetal acidosis) (Holt, ¶23).
Khandoker relates generally to a proposed beat to beat fetal heart rate measurement system (page 1, ¶1). Khandoker further teaches the invention using the following steps:
decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data to extract mechano-acoustically sensed fetal phonocardiogram (fPCG) data (page 5, last ¶-fetal phonocardiogram signal processing, the raw phonocardiogram signal to be decomposed; Fig. 5); determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data (page 9, Table 2-comparison of fetal heart rate (FHR) and heart rate variability (from 1 minute heart rate time series) extracted from fetal ECG and fetal Phonocardiogram (FPCG) recordings).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Queyam to include decomposing the mechano-acoustically sensed aPCG data using the optically sensed mPPG data to extract mechano-acoustically sensed fetal phonocardiogram (fPCG) data; determining fetal heart rate variability (fHRV) data from the mechano-acoustically sensed fPCG data of Khandoker in order to have a low cost and non-invasive fetal phonocardiography based signal system to measure the fetal heart sounds and fetal heart rate (Khandoker, page 1, ¶1).
Hayes relates generally to the monitoring of fetal movements, commonly referred to as fetal activity, in the womb (page 1, ¶1). Hayes further teaches the invention using the following steps:
and upon detecting reduced fM activity, transitioning to a second mode comprising (page 28, ¶1-determination of reduced or abnormal fetal movement; page 21, ¶3-a further mode; page 7, ¶3-a second mode): and providing an alert to the expecting mother based on the fHRV data (page 24, last ¶-processor may control output of an alarm or other visual, audible or tactile alert to the mother warning her; page 27, last ¶-record fetal heart rate alongside fetal movements to provide HRV (Heart Rate Variability) analysis).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Queyam to include and upon detecting reduced fM activity, transitioning to a second mode comprising and providing an alert to the expecting mother based on the fHRV data of Hayes in order to provide equipment offering more reliable and/or convenient monitoring of fetal activity in a home environment (Hayes, page 3, ¶2).
Regarding claims 4 and 20, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device and the method of claims 1 and 17, wherein the microcontroller is further configured to calculate fetal movement (fM) data from the mechano-acoustically sensed aPCG data (Khandoker, Fig. 4-four-channel unprocessed fetal phonocardiogram signals with 4 FPCG sensors. Ch 1–4 show maternal breathing movement (as low frequency baseline oscillation), and maternal and fetal heart movements (as high frequency oscillations)).
Regarding claim 7, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1, calculating a maternal activity level (Hayes, page 15-activity level; page 16, ¶3) from the optical sensor (Holt, ¶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).
Regarding claim 8, the combination Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1, further comprising one or more of: a MEMS inclinometer, an inertia sensor, and a gyroscope (Hayes, page 14, ¶2-a gyro, an inertial motion sensor).
Regarding claim 9, Holt teaches a patch that removably attaches to the 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 24, the combination of Queyam, Holt, Khandoker, and Hayes The wearable fetal health monitoring device of claim 1, wherein the passive sensor is selected from the group consisting of a microelectromechanical system (MEMS), an accelerometer, and a ferroelectric nanogenerator sensor (Queyam, page 620, ¶2-3-axis accelerometer).
Regarding claim 25, the combination of Queyam, Holt, Khandoker, and Hayes teaches the wearable fetal health monitoring device of claim 1, wherein the securing device is selected from the group consisting of a belt, a band, and an adhesive patch (Khandoker, page 3, elastic belts proved a simple, efficient and comfortable way to place the sensors in a consistent pattern without the need for previous knowledge of the fetal lie or position).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Venugopalan (US 20170049414 filed on 5/22/15), hereinafter referred to as Ven.
Regarding claim 5, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes does not teach wherein the optical sensor is further configured to sense maternal peripheral capillary oxygen saturation (mSpO2) data; and transitioning to the second mode is further based upon detecting reduced mSpO2 data.
Venugopalan teaches wherein the optical sensor is further configured to sense maternal peripheral capillary oxygen saturation (mSpO2) data (¶35-maternal pulse oximetry (SpO2); ¶43); and transitioning to the second mode is further based upon detecting reduced mSpO2 data (¶29).
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 of the claimed invention to modify the invention of Queyam to include wherein the optical sensor is further configured to sense maternal peripheral capillary oxygen saturation (mSpO2) data; and transitioning to the second mode is further based upon detecting reduced mSpO2 data of Ven 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 Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Stahmann (US 7787946 filed on 9/1/04).
Regarding claim 6, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes does not teach wherein the passive sensor comprises at least one of an acoustic wave sensor and a pressure wave sensor.
Stahmann teaches wherein the passive sensor 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 of the claimed invention to modify the invention of Queyam to include wherein the passive sensor comprises at least one of an acoustic wave sensor and a pressure wave sensor of Stahmann 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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Zia (US 20140180153 filed on 12/23/13).
Regarding claim 11, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes 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 of the claimed invention to modify the invention of Queyam to include an acoustic impedance matching housing of Zia in order for adaptively canceling noise in an acoustic heart signal and/or automatically editing heart sound data (Zia, ¶10).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Ransbury (US 20180317789 filed on 5/2/18).
Regarding claim 13, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes 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 of the claimed invention to modify the invention of Queyam to include an inclinometer sensor that detects a sub- audible abdominal acoustic wave of Ransbury 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 Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Khine (US 20170086709 A1 as cited in the IDS and filed on 5/18/15).
Regarding claim 14, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes does not teach wherein a first portion of the wearable fetal health monitoring device is disposable, and a second portion of the fetal health monitoring device  is re-usable.
Khine teaches wherein a first portion of the device is disposable, and 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 of the claimed invention to modify the invention of Queyam to include wherein a first portion of the wearable fetal health monitoring device is disposable, and a second portion of the wearable fetal health monitoring device is re-usable of Khine 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).
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Bureev (RU 2656518 filed on 3/6/14).
Regarding claim 16, the combination of Queyam, Holt, Khandoker, and Hayes teaches the device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes 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).
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).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Queyam to 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 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, the combination of Queyam, Holt, Khandoker, and Hayes teaches the method of claim 17. However, the combination of Queyam, Holt, Khandoker, and Hayes does not teach outputting at least one of a normal state, caution state, and emergency state based on the mechano-acoustically sensed fPCG data.
Bureev teaches outputting at least one of a normal state, caution state, and emergency state based on the mechano-acoustically sensed fPCG data (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 of the claimed invention to modify the invention of Queyam to include outputting at least one of a normal state, caution state, and emergency state based on the mechano-acoustically sensed fPCG data of Bureev 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).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Oliveira (NPL “Adaptive Sojourn Time HSMM for Heart Sound Segmentation” published in 2019).
Regarding claim 22, the combination of Queyam, Holt, Khandoker, and Hayes teaches the wearable fetal health monitoring device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes does not teach wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using a Hidden Semi-Markov Model (HSMM).
Oliveira teaches wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using a Hidden Semi-Markov Model (HSMM) (page 649, left col., ¶2-HSMMs to segment a PCG signal into its main sound components; page 645, left col., ¶1-estimate the heart rate).
Oliveira relates to a new algorithm for heart sound segmentation using a hidden semi-Markov model (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Queyam to include wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using a Hidden Semi-Markov Model (HSMM) of Oliveira in order to segment a PCG signal into its main sound components (Oliveira, page 649, left col., ¶2).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Queyam in view of Holt, Khandoker, and Hayes as applied to claims 1, 4, 7-9, 17, 20-21, and 24-25 above, and further in view of Vadali (NPL “Fetal Phonocardiogram Decomposition Framework” published in 2018).
Regarding claim 23, the combination of Queyam, Holt, Khandoker, and Hayes teaches the wearable fetal health monitoring device of claim 1. However, the combination of Queyam, Holt, Khandoker, and Hayes does not teach wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using empirical mode decomposition (EMD).
Vadali teaches wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using empirical mode decomposition (EMD) (page 2, left col., last ¶-EMD is used to decompose the FPCG signal; page 4, left col., ¶1-study can also be refined to detect the short term variability in the Fetal Heart Rate).
Vadali relates to an efficient procedure to identify vital bio-signals from the Fetal Phonocardiogram (FPCG) signal (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Queyam to include wherein determining fHRV data from the mechano-acoustically sensed fPCG data comprises using empirical mode decomposition (EMD) of Vadali in order to extract the vital bio-signals in a single step (Vadali, Abstract).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.  Accordingly, THIS ACTION IS MADE FINAL.  See MPEP § 706.07(a).  Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action.  In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action.  In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.

CITED REFERENCE SUMMARIES: Ref US20180336968A1: [content unavailable]
Ref US20180092564: Claims:
1. 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.
2. 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.
3. 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.
4. A method according to claim 1, wherein the sensor is a 2-axis acceleration sensor.
5. 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.
6. 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.
7. A monitoring system according to claim 6, wherein the recoil surface is a flat surface on which a test subject can lie.
8. A monitoring system according to claim 6, wherein the surface is the outside of a belly, with the test subject inside.
9. A monitoring system according to claim 6, wherein the sensor is a 2-axis acceleration sensor.
10. 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.
Ref US20170281087: Claims:
1. A system for monitoring fetal health data and/or mother health data, comprising:
a belly-covering garment, wherein the belly-covering garment is configured to at least partially cover a belly and to hold one or more sensor modules directly adjacent to the belly; and the one or more sensor modules disposed at particular locations within the belly-covering garment, wherein the one or more sensor modules comprise:
a pulse-oximeter sensor, wherein the pulse-oximeter sensor gathers pulse oximetry data from a mother through contact with the belly;
an accelerometer sensor, wherein the accelerometer sensor gathers movement data from the mother; and
a fetal sensor, wherein the fetal sensor gathers fetal health data from a fetus within the belly.
2. The system as recited in claim 1, wherein the one or more sensor modules are disposed within an array of sensors spread across at least one axis of the belly and the array of sensors is configured to detect a relative location of the fetus within the belly.
3. The system as recited in claim 2, wherein the array of sensors detects a location of the fetus within the belly by detecting an individual detection sensor that is receiving the strongest signal from the fetus.
4. The system as recited in claim 2, wherein the one or more sensor modules comprise individual Doppler sensors.
5. The system as recited in claim 2, wherein the one or more sensor modules comprise individual microphone sensors.
6. The system as recited in claim 1, wherein the pulse-oximeter sensor is configured to measure the heart rate of the mother and the fetal sensor is configured to measure the heart rate of the fetus, and data from the pulse-oximeter sensor is used to remove noise in data from the fetal sensor.
7. The system as recited in claim 1, wherein the accelerometer sensor is configured to detect movements and kicks from the fetus.
8. The system as recited in claim 1, wherein:
the fetal sensor comprises multiple individual sensor units that are each configured to gather a heart rate from the fetus; the fetal sensor is configured to identify a particular individual sensor unit from the multiple individual sensor units that is receiving the strongest heart rate signal; and the fetal sensor is configured to decrease the power supplied to the multiple individual sensor units except the particular individual sensor unit.
9. A method for monitoring fetal health data and/or mother health data, comprising:
receiving, from a pulse-oximeter sensor, pulse oximetry data from a mother; receiving, from an accelerometer sensor, movement data from the mother; receiving, from a fetal sensor, fetal health data from a fetus within the mother's belly; identifying a relative location of the fetus within the mother's belly using one of more of the pulse oximetry, the movement data, and the fetal health data; and wherein the pulse-oximeter sensor, the accelerometer sensor, and the fetal sensor are disposed within a belly-covering garment that is configured to at least partially cover the mother's belly and to hold one or more sensor modules directly adjacent to the belly.
10. The method as recited in claim 9, wherein one or more of the pulse-oximeter sensor, the accelerometer sensor, and the fetal sensor are disposed within an array of sensors spread across at least one axis of the belly.
11. The method as recited in claim 10, wherein identifying the relative location of the fetus within the mother's belly comprises:
detecting an individual sensor within the array of sensors that is receiving the strongest signal from the fetus.
12. The method as recited in claim 10, wherein the fetal sensor comprises a Doppler sensor.
13. The method as recited in claim 10, wherein the fetal sensor comprises a microphone sensor.
14. The method as recited in claim 9, further comprising:
measuring, with the pulse-oximeter sensor, a heart rate of the mother; measuring, with the fetal sensor, a heart rate of the fetus; and calculating a filtered heart rate of the fetus by subtracting the measured heart data of the mother from the measured heart rate of the fetus.
15. The method as recited in claim 9, further comprising:
detecting activity from an electrocardiogram sensor, wherein the electrocardiogram sensor is in contact with the mother's belly; detecting a lack of movement from the accelerometer sensor; and identifying a fetal movement based upon the presence of the activity from the electrocardiogram sensor and the lack of movement detected by the accelerometer sensor.
16. The method as recited in claim 9, further comprising:
identifying a particular individual sensor unit from the multiple individual sensor units that is receiving the strongest heart rate signal; and the fetal sensor is configured to decrease the power supplied to the multiple individual sensor units except the particular individual sensor unit.
17. A system for monitoring fetal health data and/or mother health data, comprising:
a garment that is configured to at least partially cover a belly and to hold a plurality of sensor modules directly adjacent to the belly; the plurality of sensor modules disposed individually as an array of sensor modules spread across the belly; a first sensor module comprises a first electrocardiogram electrode that is configured to gather first fetal heartbeat data, wherein the first sensor module is associated with a first region of the belly; a second sensor module comprises a second electrocardiogram electrode that is configured to gather second fetal heartbeat data, wherein the second sensor module is associated with a second region of the belly that is different than the first region; and wherein a computing system is configured 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.
18. The system as recited in claim 17, further comprising:
at least one sensor module comprising an accelerometer sensor that is configured to gather movement data from the mother; and wherein the computing system is configured to identify fetal movement based upon a presence of fetal activity detected the first electrocardiogram electrode and a lack of movement detected by the accelerometer sensor.
19. The system as recited in claim 17, wherein:
the first electrocardiogram electrode comprises a fabric electrode that is configured to contact the belly; and the first electrocardiogram electrode is backed by an elastomeric material that exerts a force on the first electrocardiogram electrode towards the belly.
20. The system as recited in claim 17, wherein the garment further comprises a ground electrode configured to be positioned over a hip of a wearer.
Ref US20180336968: Claims:
1. A system for estimating a degree of distraction based on unconstrained bio-information, the system comprising:
a degree-of-distraction measurement chair comprising a seating unit, a message transmission unit, a pressure detection unit, and a support unit, which are formed in this order from the top to the bottom thereof, wherein the pressure detection unit formed on the support unit comprises a smart sensor including three load cells arranged at three vertices of a triangular shape on a plane; and a mobile smart terminal configured to receive information regarding the degree of distraction from the message transmission unit of the degree-of-distraction measurement chair through the Bluetooth communication, wherein the smart sensor is formed as a multi-channel sensor for simultaneously monitoring multiple items of information comprising posture information, ballistocardiogram, and body weight using the three load cells that are multi-sensor-based posture measuring sensors and simultaneously measuring the magnitude and directional value of the posture information, wherein the message transmission unit comprises an interface module comprising a microprocessor configured to be connectable to an external sensor through an extension connector to allow for bio-measurement and configured to perform A/D conversion of an acquired bio-measurement signal and wireless transmission of data, and wherein the microprocessor extracts, from the smart sensor, a sitter's body weight information measured one time when the sitter is first seated on the degree-of-distraction measurement chair upon the monitoring of posture information, and detects a change in posture distribution from the distribution of the body weight information received by the smart sensor through creation of correction information of preset correct posture information.
2. The system according to 1, wherein the microprocessor monitors a posture change or type of motion in the form of frequency and intensity, estimates the posture information by separating frequency information of the posture change and intensity information of the posture change, and reflects the posture information on the evaluation of degree of distraction.
3. The system according to of claim 2, wherein the frequency information of the posture change is the number of generations per unit time of an inducing factor of the posture change according to motion, and the intensity information of the posture change is directionality as a magnitude of motion.
4. The system according to claim 3, wherein the microprocessor provides a posture change rate indicator and parameter using parameters, comprising the frequency of the posture change and the intensity of the posture change, extracted upon the monitoring of the posture change, at which time, the microprocessor calculates an average frequency through a measurement experiment and a statistical analysis, which are targeted to a plurality of subjects, and then provides the frequency by scoring the frequency based on a standard deviation using an intermediate value as an average value.
5. The system of claim 4, wherein the microprocessor receives a brain wave signal from an external brain wave measuring device connected to the interface module in order to generate a degree-of-distraction index through the analysis and comparison of brain waves, conducts comparison and evaluation based on preset reference brain wave information, so that brain wave information measured in the left brain in a state where concentration is low, brain wave information measured in the left brain in a state where concentration is high, brain wave information measured in the right brain in a state where concentration is low, and brain wave information measured in the right brain in a state where concentration is high, and an alpha (a) wave and an SMR wave of a brain wave extracted by the brain wave measuring device, analyzes the posture information in a seated state and the brain wave measured simultaneously with the posture information upon the monitoring of the brain wave signal at a concentrated state and an unconcentrated state, and analyzes the correlation between the extracted brain wave and the degree of distraction to thereby generate a degree-of-distraction parameter.
Ref US20100305481: Claims:
1. A method of automatically monitoring the movement activity of a fetus, the method comprising the steps of:
detecting (200) overall movements of a pregnant female, said overall movements comprising movements of the pregnant female and movements of the fetus; detecting at least one second physiological signal (26) of the pregnant female; and determining (300) the movement activity of the fetus by analyzing the detected overall movements of the pregnant female, analyzing the at least one second physiological signal (26) of the pregnant female, and discriminating movements of the pregnant female from movements of the fetus depending on the analyzing results.
2. The method as claimed in claim 1, wherein the energy of a movement signal (22) of the pregnant female is analyzed.
3. The method as claimed in claim 1, wherein the pregnant female's heart rate and/or heart rate variability is used as second physiological signal (26).
4. The method as claimed in claim 3, wherein a movement is classified as child movement, if the movement does not correlate with a changing of the pregnant female's heart rate.
5. The method as claimed in claim 1, wherein the movements of the pregnant female are detected during the pregnant female's sleep.
6. A system (1) for automatically monitoring movement activity of a fetus, the system comprising:
at least one sensor (2) for detecting overall movements of a pregnant female, said overall movements comprising movements of the pregnant female and movements of the fetus; at least one sensor (3) for detecting at least one second physiological signal (26) of the pregnant female; and an analyzing device (7) for determining the movement activity of the fetus by analyzing the detected overall movements of the pregnant female and analyzing the at least one second physiological signal (26) of the pregnant female; said analyzing device (7) comprising a discriminator (13) for discriminating movements of the pregnant female from movements of the fetus depending on the analyzing results.
7. The system (1) as claimed in claim 6, wherein the at least one sensor (2) for detecting movements and/or the at least one sensor (3) for detecting at least one second physiological signal (26) of the pregnant female is connected to or integrated into a bed (5).
8. A computer program to be executed in a computer (13), for automatically monitoring movement activity of a fetus, said computer program comprising computer instructions to determine the movement activity of a fetus by
analyzing previously detected overall movements of a pregnant female, said overall movements comprising movements of the pregnant female and movements of the fetus; analyzing at least one previously detected second physiological signal of the pregnant female; and discriminating movements of the pregnant female from movements of the fetus depending on the analyzing results.
Ref US20170049414: Claims:
1. 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.
2. 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.
3. 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.
4. 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.
5. The sensor of claim 1, wherein the remote ultrasound processing system is a cloud based system.
6. The sensor of claim 1 further comprises a position identifying module configured to locate positional information associated with the sensor.
7. 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.
8. 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 ma
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