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
The amendments and remarks filed on 24JUL2025 have been entered and considered.
Claims 1-13 are currently pending.
Claims 1-2 & 12 have been amended.
Claims 14-20 are withdrawn.
No claims have been added or canceled by the applicant.
No new matter has been added.
Claims 1-13 are under examination.
Response to Arguments
Applicant's arguments filed 24JUL2025 regarding the rejections under 35 USC 24JUL2025 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 9 of the Remarks):
“Unlike the Baumhauer approach, it's simply not feasible to position an acoustic waveguide in front of the piezofilm in Kabakov, as doing so would obstruct the essential direct contact with the abdomen.”
The examiner disagrees as You can use both a piezofilm and an acoustic waveguide by coupling them together, allowing the piezofilm to act as the transducer that generates or senses acoustic signals that are then guided by the waveguide. Nowhere in Kabakov does it state that the piezofilm needs a direct contact to the patient to function, and waveguides can be designed so that is is near direct contact. The piezofilm cans till function with a waveguide integrated as this waveguide can be custom for the device and is not restricted to a certain type of waveguide. Therefore, it is maintained that the combination teaches the claim limitations and it would be obvious to combine the references to arrive at the claimed invention.
“Kabakov employs microphones for noise reduction, rather than for fetal heart rate sensing”.
The examiner maintains that Kabakov teaches the limitation since it is not required that the microphone is for fetal heart rate sensing, as this is not claimed. ¶0032 of Kabakov states “In a non-limiting embodiment, the sound obtained from the microphone 56 may be used for voice command input or adaptive noise cancellation (ANC).”. This shows the functionality of the microphone is both sensing and noise cancellation. Kabakov discloses the claimed invention except for a plurality of microphones. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the microphones, for the purpose of advanced acoustic acquisition, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
“Penders calculates hemodynamics using bio-impedance whereas our invention calculates hemodynamics using processed acoustic signals from the signal analysis system. The substantial difference between calculating fetal hemodynamics using bio-impedance compared to acoustic signals renders it non-obvious for a person of ordinary skill in the art to combine the acoustic component of the Kabakov/Baumhauer system for fetal hemodynamics detection in Penders.”
The examiner maintains that Penders teaches the claim limitation as amended in Column 10 Lines 14-24 “An acoustic sensor, for example an ultrasound sensor, as described herein uses acoustic waves propagated through a portion of the abdomen (may include a portion of the uterus and/or fetus) of the pregnant women to measure characteristics of the pregnant women, uterus, placenta, fetus, or any other characteristic of the fetus or structure supporting the growth of the fetus. As the acoustic waves propagate through the abdomen, one or more characteristics of the waves change, for example in velocity, amplitude, etc. These changes are monitored by the sensor and output as a sensor signal.”. Which shows that the acoustic signals are used to detect information about the patient, such as hemodynamic parameters.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kabakov et al. (US Publication No. 20140249436; Previously Cited) in view of Baumhauer et al. (US Patent No. 5226076; Previously Cited).
Regarding claim 1, Kabakov discloses a device for sensing perinatal maternal uterine activity and fetal heart activity (Kabakov Abstract “A controller is operably connected to the piezofilm sheet, first electrode, and second electrode and receives a biopotential and a piezofilm signal. The controller derives at least one of a maternal heart rate and a uterine activity for the biopotential and derives at least one of a fetal heart rate and fetal motion detection from the piezofilm signal. The controller derives an index of fetal health and operate an indicator to present the derived index of fetal health.”; ¶0004 “The controller derives at least one of fetal heart rate and fetal motion detection from the acoustic signal and at least one maternal heart rate and uterine activity from the biopotential. The controller calculates an index of fetal health from the at least one of fetal heart rate and fetal motion detection and at least one of maternal heart rate and uterine activity. A visual indicator is operable by the controller to present the calculated index of fetal health.”); a housing (Kabakov Figure 1 as described in ¶0020 “In the embodiment of the fetal monitoring device 10, the fetal monitoring device is incorporated into a glove to be worn by the patient…”; Where the examiner is interpreting the glove as the housing.; ¶0044)with an electromechanical system disposed therein (Kabakov ¶0022 “A piezofilm 20 is secured to the forehand side 12 of the fetal monitoring device 10.”); a passive acoustic system (Kabakov ¶0061 “Embodiments of the fetal monitoring device as disclosed herein use passive technologies and incorporate a sleep or low power mode when a maternal pulse is not detected and only operate the fetal monitoring device at times when a maternal pulse is present. These features minimize battery use and maximize battery life.”), the passive acoustic system including a microphone (Kabakov ¶0032 “Additionally, optional additional inputs including, an accelerometer 54 and a microphone 56 may be incorporated, as described herein.”; ¶0036; ¶0050; ¶0055); an attachment component configured to secure the device securely against a human body (Kabakov ¶0005 “An exemplary alternative embodiment of a fetal monitoring device includes at least one glove configured to be worn by a patient. The glove includes a forehand side, a backhand side, a thumb region, and at least one finger region. A piezofilm sheet is secured to an exterior of the forehand side of the at least one glove. A first electrode is secured to the forehand side of the thumb region. A second electrode is secured to the forehand side of at least one finger region.”; ¶0048); an accelerometer for sensing motion activity (Kabakov ¶0032 “Additionally, optional additional inputs including, an accelerometer 54 and a microphone 56 may be incorporated, as described herein.”; ¶0055 “In still further embodiments, other sensed signals such as an acceleration signal, or an ambient noise signal from a microphone, can be used to derive parameters or the index of fetal heath in manners as described above.”; ¶0033); a signal analysis system comprising a microcontroller unit configured to process acoustic and biopotential signals (Kabakov ¶0026 “The controller 26 receives the signals from the structures as described above and processes those signals in manners as described in further detail herein. The controller 26 can be implanted in software operated by a processor, analog, circuitry, or a combination of both to carry out the functions and operations as described herein. The controller applies one or more algorithms to the acquired signals in order to determine whether the acquired signals represent reassuring or non-reassuring patterns such as to derive an index of fetal health. After determining the index of fetal health, exemplarily whether the patterns represent reassuring or non-reassuring patterns, the controller operates an indicator 32 such as to present the derived index of fetal health. Such an indicator 32 may be implemented as any of a variety of indicators, including, but not limited to, one or more light emitting diodes (LEDs) or LCD display to provide visual indications. In embodiments, the indicator 32 can be part of the controller 26. Alternatively, or in addition to visual indications, an audible or tactile indication may be provided such as from a speaker to provide an audible output or an eccentric oscillator to provide a vibration or tactile output.”), wherein the microcontroller unit is configured to reduce motion artifacts from the acoustic and biopotential signals using the accelerometer and to calculate an acoustic fetal heart signal quality index (Kabakov ¶0032 “In an embodiment, two input signals, namely ECG 66 and PCG 68, once digitized, are used in order to determine the index of fetal health. In a non-limiting embodiment, the sound obtained from the microphone 56 may be used for voice command input or adaptive noise cancellation (ANC). The acceleration signal (ACM) 64 (e.g. signal from accelerometer 54) may also be used for ANC.”; ¶0036; ¶0040); and a wireless transceiver configured to share information between the signal analysis system (Kabakov ¶0029 “Although it will be recognized in alternative embodiments, the second controller 46 may alternatively be a more simplified circuitry such as described herein, and wherein in an exemplary embodiment, the circuitry in place of second controller 46 is merely directed towards the transmission (e.g. wireless transmission) of the acquired signals to the controller 26.”; ¶0047; ¶0051); and a base station with a user interface. (Kabakov ¶0047 “The wireless transmitter 138 transmits the obtained pre-PCGL signal to a wireless receiver 140 incorporated in the signal processing portion 48, in an exemplary embodiment, the wireless transmission between transmitter 138 and receiver 140 may be performed using wireless body area network (WBAN).”). Kabakov discloses the claimed invention except for a plurality of microphones. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the microphones, for the purpose of advanced acoustic acquisition, since it would have been obvious to one having ordinary skill in the art at the time the invention was made to have a plurality of Kabakov microphones in the device, since It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Kabakov does not disclose an acoustic waveguide. Baumhauer in a similar field of acoustics teaches an acoustic waveguide (Baumhauer Claim 1 “a first acoustic waveguide, having only one input port, for guiding sound waves that effectively emanate from a point source at its input port to one side of the diaphragm; and (ii) an identically shaped second acoustic waveguide, having only one input port, for guiding sound waves that effectively emanate from a point source at its input port to the other side of the diaphragm, said housing being formed from an acoustically opaque material; whereby the first and second acoustic waveguides function to increase the path distance between opposite sides of the microphone element and thus improve microphone sensitivity and directivity.; Claim 13 “input port of the first acoustic waveguide, and for exclusively communicating same to one side of the diaphragm, and a second acoustic waveguide molded therein, identical in shape to the first acoustic waveguide and having only one input port, for guiding sound pressure variations, effectively emitting from a point source at the input ports of the second acoustic waveguide, and for exclusively communicating same to the other side of the diaphragm.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify system in Kabakov with items in Baumhauer by integrating the acoustic waveguide into the acoustic system of Kabakov. The addition of Baumhauer allows for an improved device which can actively filter acoustics to aide in removing outside noise during diagnostics and improve overall monitoring results. The motivation to integrate this into the system of Kabakov would be to create a system that is comfortable for the user as it is a more compact and sensitive design, and allows for clear signal acquisitions. The acoustic waveguide specifically aids in increasing the devices therapeutic power and aids in steering the acoustics so that signals are not lost in polarization.
Regarding claim 2, Kabakov does not teach wherein the acoustic system is acoustically isolated from the housing. Baumhauer teaches wherein the acoustic system is acoustically isolated from the housing. (Baumhauer Abstract “The housing supports the microphone element and forms a continuous seal around its perimeter so that sound pressure in one channel does not leak into the other.”; Column 2 Lines 48-56 “In an illustrative embodiment of the invention, the housing is molded from Ethylene-Propylene-Diene-Monomer which is rubber-like material that is resilient. It forms an excellent seal around the perimeter of the microphone element so that sound pressure in one channel does not leak into the other. Moreover, the rubber-like material forms a seal with the surface of sound-input equipment where it is housed.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify system in Kabakov with items in Baumhauer by integrating the acoustic isolation from the housing as taught in Baumhauer into the acoustic system disclosed by Kabakov. The addition of Baumhauer allows for an improved device which can passively filter acoustics by reducing internal artifacts caused by signal polarization which will improve overall monitoring results. The motivation to integrate this into the system of Kabakov would be to create a system that is comfortable for the user as it is a more compact and sensitive design, and allows for clear signal acquisitions. The acoustic waveguide specifically aids in increasing the devices therapeutic power and aids in steering the acoustics so that signals are not lost in polarization.
Regarding claim 3, Kabakov further discloses wherein the microphones include at least a sensing microphone and a noise-canceling microphone. (Kabakov ¶0032 “In a non-limiting embodiment, the sound obtained from the microphone 56 may be used for voice command input or adaptive noise cancellation (ANC). The acceleration signal (ACM) 64 (e.g. signal from accelerometer 54) may also be used for ANC.”; ¶0036; ¶0050. The references showing that the microphone is sensing and also noise canceling as it aids the system to remove maternal noise inputs). Kabakov discloses the claimed invention except for a plurality of microphones. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the microphones, for the purpose of advanced acoustic acquisition, since it would have been obvious to one having ordinary skill in the art at the time the invention was made to have a plurality of Kabakov microphones in the device, since It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 4, Kabakov further discloses wherein the signal analysis system is further configured to remove external noise by subtracting the signal provided from the noise-canceling microphone from the signal provided from the sensing microphone. (Kabakov ¶0033 “At 72, adaptive noise cancellation is applied to remove maternal breathing artifacts (MBA ANC) from the ECG signal obtained after the MMA ANC. The MBA ANC 72 uses the accelerometer signal 64 which includes the maternal patient's respiration pattern on top of the maternal and fetal motion patterns.”; ¶0040 “In an alternative embodiment, an autocorrelation of the PCG may additional be used to remove or reduce these remaining artifacts.”).
Regarding claim 5, Kabakov does not disclose wherein the passive acoustic system further comprises: a resonance chamber; and a tunable frequency diaphragm configured to transduce vibrations from the body into pressure waves. Kabakov further does not teach this. However, Baumhauer further teaches wherein the passive acoustic system further comprises: a resonance chamber (Baumhauer Column 5 Lines 49-53 “However, housing 110 includes openings 111, 112 which admit sound pressure, via acoustically transparent channels 113-114, into the cavity where the microphone element 200 (see FIG. 8) resides.”; Figures 7 & 9); and a tunable frequency diaphragm configured to transduce vibrations from the body into pressure waves. (Baumhauer Claim 8 “A microphone assembly including an electroacoustic transducer having a diaphragm which moves in response to sound pressures being applied to opposite surfaces thereof, said electroacoustic transducer being housed in a rigid capsule having acoustic openings which admit sound pressure to each of diaphragm's surfaces,”; Column 2 Lines 35-47 “A directional microphone assembly is constructed from a microphone element enclosed within a housing made from an acoustically-opaque, resilient material. The microphone element includes a diaphragm which moves under the influence of sound pressure applied to its opposite surfaces to generate an electrical signal which is proportional to the differential sound pressure. The housing includes a first acoustically-transparent channel for communicating sound pressure from a first opening in the housing to one surface of the diaphragm, and a second acoustically-transparent channel for communicating sound pressure from a second opening in the housing to the other surface of the diaphragm.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify system in Kabakov with items in Baumhauer by integrating the resonance chamber and a tunable frequency diaphragm configured to transduce vibrations from the body into pressure waves into the acoustic system of Kabakov. The addition of the teachings of Baumhauer allows for an improved device which can actively filter and enhance acoustics to aide in removing outside noise during diagnostics and improve overall monitoring results. The motivation to integrate this into the system of Kabakov would be to create a system that is comfortable for the user as it is a more compact and sensitive design, and allows for clear signal acquisitions.
Regarding claim 6, Kabakov does not disclose wherein the passive acoustic system is configured to transduce a plurality of pressure waves, and the plurality of pressure waves are received by a sensing microphone. Kabakov further does not teach this. Baumhauer further teaches wherein the passive acoustic system is configured to transduce a plurality of pressure waves, and the plurality of pressure waves are received by a sensing microphone. (Baumhauer Claim 8; Column 2 Lines 35-47; Abstract “The housing includes a first acoustically-transparent channel for communicating sound pressure from a first opening in the housing to one surface of the diaphragm, and a second acoustically-transparent channel for communicating sound pressure from a second opening in the housing to the other surface of the diaphragm. The housing supports the microphone element and forms a continuous seal around its perimeter so that sound pressure in one channel does not leak into the other.”; where it is expected of the device to produce a multitude of data and not a singular discrete value.; Column 7 Lines 3-6 “Further, rather than using a single FOG microphone element, the use of two electrically-interconnected, pressure microphone elements is contemplated within the spirit of the invention.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify system in Kabakov with items in Baumhauer by integrating the method of transducing a plurality of pressure waves, and the plurality of pressure waves are received by a sensing microphone of Kabakov. The addition of Baumhauer allows for an improved device which can actively filter and enhance acoustics to aide in removing outside noise during a continuous diagnostic and improve overall monitoring results. The motivation to integrate this into the system of Kabakov would be to create a system that allows for clear signal acquisitions over an extended period of time.
Regarding claim 7, Kabakov does not disclose wherein the acoustic waveguide includes a sealing component, the sealing component configured to maintain a sealed pressure path from a frequency diaphragm to a sensing microphone. Kabakov further does not teach this. Baumhauer further teaches wherein the acoustic waveguide includes a sealing component, the sealing component configured to maintain a sealed pressure path from a frequency diaphragm to a sensing microphone. (Baumhauer Abstract “The housing supports the microphone element and forms a continuous seal around its perimeter so that sound pressure in one channel does not leak into the other. The distance between the openings is relatively large in order to improve the sensitivity and directivity of the microphone. Moreover, the directional microphone assembly is configured to be embedded within, or behind, an exterior surface of sound-input equipment with the openings of the housing located along the exterior surface. The resilient housing structure forms a seal with the sound-input equipment surface.”; Column 5 Lines 55-58 “Housing 110 is sized to form a seal with the microphone element 200 so that the sound pressure in one of the channels is not leaked to the other channel around the microphone element.”; Claim 1; Claim 13 “input port of the first acoustic waveguide, and for exclusively communicating same to one side of the diaphragm, and a second acoustic waveguide molded therein, identical in shape to the first acoustic waveguide and having only one input port, for guiding sound pressure variations, effectively emitting from a point source at the input ports of the second acoustic waveguide, and for exclusively communicating same to the other side of the diaphragm.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify system in Kabakov with items in Baumhauer by integrating the acoustic waveguide includes a sealing component, the sealing component configured to maintain a sealed pressure path from a frequency diaphragm to a sensing microphone into the acoustic system of Kabakov. The addition of Baumhauer allows for an improved device which can actively filter and enhance acoustics to aide in removing outside noise during a continuous diagnostic, and improve overall monitoring results by reducing the noise from outside components. The motivation to integrate this into the system of Kabakov would be to create a system that allows for clear signal acquisitions over an extended period of time.
Regarding claim 8, Kabakov does not disclose a pressure modification component is designed to improve signal quality by adjusting a pressure of a face of the acoustic waveguide against the body. Kabakov further does not teach this. Baumhauer further teaches a pressure modification component is designed to improve signal quality by adjusting a pressure of a face of the acoustic waveguide against the body. (Baumhauer Column 5 Lines 32-37 “This distance "d" is a parameter that directly affects the sensitivity of the associated microphone as well as its frequency, and sometimes affects the polar response characteristics. Unfortunately, this baffle must be oriented perpendicular to the sound-input equipment surface and its shape must be accommodate in the design of said equipment--thus limiting design flexibility.”; Column 6 Lines 64-68 & Column 7 Lines 1-7 “Although a particular embodiment of the present invention has been shown, it is clear that modifications are possible within the scope of the invention. Such modifications include, but are not limited to, the use of resilient materials other than EPDM for fabricating the housing, the use of housings that are not molded, and openings in the housing that are non-circular or that do not reside in the same plane. Further, rather than using a single FOG microphone element, the use of two electrically-interconnected, pressure microphone elements is contemplated within the spirit of the invention.”; Showing how one may modify the invention to improve the pressure values for improved data quality, by means of material replacement, or the distance between components.).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify system in Kabakov with items in Baumhauer by integrating a pressure modification component is designed to improve signal quality by adjusting a pressure of a face of the acoustic waveguide against the body into the acoustic system of Kabakov. The addition of Baumhauer allows for an improved device which can actively filter and enhance acoustics to aide in removing outside noise during a continuous diagnostic, and improve overall monitoring results by reducing the noise from outside components. The motivation to integrate this into the system of Kabakov would be to create a system that allows for clear signal acquisitions over an extended period of time.
Regarding claim 9, Kabakov further discloses a plurality of electrodes in electrical communication with the signal analysis system. (Kabakov ¶0028 “FIG. 2 depicts exemplary use and placement of the fetal monitoring device 10 over the abdomen of the maternal patient 34. Such placement exemplarily may position the patient's palm (and the piezofilm 20) over the fetus, while the first electrode 22 and the second electrode 24 are stretched apart at a maximum distance across the fetus and uterus. The operation of the embodiment depicted in FIGS. 1 and 2 will be described herein in further detail with respect to the schematic diagram provided at FIG. 5.”; ¶0025 “In the embodiment depicted in FIG. 1, the backhand side 14 of the fetal monitoring device 10 includes the communicative connections and other circuitry incorporated in the fetal monitoring device 10. It will be understood that this location of the circuitry described herein is merely exemplarily and such circuitry may be located in other configurations as appreciated by one of skill in the art. The backhand side 14 includes a controller 26 that is communicatively connected to the first electrode 22 and second electrode 24 as well as to a first piezofilm contact 28 and a second piezofilm contact 30.”; ¶0043).
Regarding claim 10, Kabakov further discloses wherein the attachment component is configured to integrate with the plurality of electrodes such that the attachment component provides an interface for external placement of the plurality of electrodes. (Kabakov ¶0028 “FIG. 2 depicts exemplary use and placement of the fetal monitoring device 10 over the abdomen of the maternal patient 34. Such placement exemplarily may position the patient's palm (and the piezofilm 20) over the fetus, while the first electrode 22 and the second electrode 24 are stretched apart at a maximum distance across the fetus and uterus. The operation of the embodiment depicted in FIGS. 1 and 2 will be described herein in further detail with respect to the schematic diagram provided at FIG. 5.”; ¶0044 “signal to place and/or remove the sensors (which may be incorporated into a glove or gloves as described above) from the abdomen of the maternal patient according to a particular time for signal acquisition”; ¶0048).
Regarding claim 11, Kabakov further discloses wherein the signal analysis system is configured to detect a fetal heart rate. (Kabakov ¶0039 “However, uterine activity spikes in the PCG signal can be effectively removed by removing frequencies below 150 Hz. The FHR detector 100 outputs the fetal heart rate 102.”; ¶0041; ¶0054; ¶0059).
Regarding claim 13, Kabakov further discloses the signal analysis system further comprising: a main control printed circuit having the microcontroller unit (Kabakov ¶0031 “…signal processing portion 48 in FIG. 5A…”; ¶0046), at least one microphone printed circuit board (Kabakov ¶0031 “… audio circuitry portion 52 in FIG. 5C…”; ¶0046)., a split power plane, and a ground plane, wherein the split power plane and the ground plane are positioned between the main control printed circuit board and the at least one microphone printed circuit board. (Kabakov ¶0031 “FIGS. 5A-C includes three portions, a signal processing portion 48 in FIG. 5A, a battery and data portion 50 in FIG. 5B, and an audio circuitry portion 52 in FIG. 5C.”; ¶0046 “FIG. 6 is a schematic diagram of an alternative exemplary embodiment of a fetal monitoring device such as depicted in FIGS. 3 and 4 as described above. It is to be noted that much of the signal processing portion 48 depicted in FIG. 6 is similar to that as described above with respect to FIG. 5A and therefore the description of FIG. 5 above is referred for those portions. It is further noted that while not depicted, embodiments of the battery and data portion 50 as shown in FIG. 5B and audio circuitry portion 52 as shown in FIG. 5C may also be used in connection with the signal processing portion 48 of FIG. 6.; Showing the circuitry of the device and how the sub circuits all go together, including controller 26, and how the items are interconnected.).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kabakov et al. (US Publication No. 20140249436; Previously Cited) in view of Baumhauer et al. (US Patent No. 5226076; Previously Cited) and Penders et al. (US Patent No. 11510607; Previously Cited).
Regarding claim 12, Kabakov nor Baumhauer disclose wherein the signal analysis system is configured to detect fetal cardiac output, stroke volume, contractility, and other hemodynamic parameters using the processed acoustic signals. Penders in the analogous field of endeavor of fetal monitoring systems teaches wherein the signal analysis system is configured to detect fetal cardiac output, stroke volume, contractility, and other hemodynamic parameters using the processed acoustic signals. (Penders Column 10 Lines 14-24 “An acoustic sensor, for example an ultrasound sensor, as described herein uses acoustic waves propagated through a portion of the abdomen (may include a portion of the uterus and/or fetus) of the pregnant women to measure characteristics of the pregnant women, uterus, placenta, fetus, or any other characteristic of the fetus or structure supporting the growth of the fetus. As the acoustic waves propagate through the abdomen, one or more characteristics of the waves change, for example in velocity, amplitude, etc. These changes are monitored by the sensor and output as a sensor signal.”). Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the system of Kabakov/Baumhauer with the method for cardiac monitoring, as taught by Penders, by integrating Penders’s ability to detect hemodynamics into the acoustic system of Kabakov and Baumhauer. The addition of Penders’s method for detecting fetal cardiac output, stroke volume, contractility, and other hemodynamic parameters using the processed acoustic signals provides an improved device using the ECG electrodes of Kabakov and Baumhauer to monitor a wider range of fetal biometrics, which can then be used to generate improved overall monitoring results by providing a stable and reliable fetal reference regardless of changing parameters such as fetal position or weight.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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