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 .
Response to Amendment
This action is in response to the remarks filed on 5/26/2026.
The amendments filed on 5/26/2026 have been entered. Accordingly claims 1-20 remain pending. Claims 12-20 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b).
The objections to the claims have been withdrawn in light of the applicant’s remarks.
The objections to the drawings have been withdrawn in light of the applicant’s remarks.
The claim rejections under35 USC 112 have been withdrawn in light of the amendments and the applicant’s remarks.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roham et al (US 20120232398).
Regarding claim 1 (as the claim best understood in light of the 35 USC 112 rejections above), Roham teaches a wearable ultrasound probe (“fetal and maternal monitoring system includes a fetal sensor unit adapted to receive signals indicative of a fetal heartbeat, the sensor optionally utilizing a Doppler ultrasound sensor” abst) comprising:
a patient-worn probe transducer assembly (see re-produced Fig. 1 below) comprising transducer elements disposed in a first housing (“[0065] FIG. 1 illustrates the form factor implementation for the different components of the sensing front-end. The central unit integrates the ultrasound transducers, processing and control circuitry,” [0065]), the transducer elements configured to transmit ultrasound beams and convert received echoes to electrical signals in response to control signals (“The fetal heartbeat detector, such as a piezoelectric ultrasound transducer 30, is an input to the sensing hardware 32. The sensing hardware 32 may be characterized as wireless, though certain embodiments contemplate wired connections. The sensing hardware 32 may optionally include an amplifier, such as a low noise amplifier (LNA). The output of the sensor 30 is provided to signal processor 34, such as Doppler signal processing detector, for processing and heartbeat detection. In turn, the signal digitization unit 36 digitizes the signal, such as through an analog to digital converter (ADC)” [0068]); and
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a patient-worn probe controller assembly comprising at least one control processor disposed in a second housing (“The device consists of a central unit 10 which houses the fetal heartbeat detector” [0059]), the at least one control processor communicatively coupled to a connected device, the at least one control processor communicatively coupled to the patient- worn probe transducer assembly via a wired connection (See above re-produced fig for central unit 10 being connected to various devices), the at least one control processor configured to provide the control signals to the patient-worn probe transducer assembly for controlling ultrasound data acquisition (“[0069] FIG. 4 shows a schematic functional block diagram of one implementation of the system. The fetal heart beat 70 is received by the sensor 72, shown in FIG. 4 with the ultrasound embodiment being a transducer and optional amplifier, most preferably a low noise amplifier. The output of the sensor 72 is communicated to the processor 74, preferably for signal processing and heartbeat detection” [0069]).
Regarding claim 3, Roham teaches wherein: the at least one control processor is communicatively coupled to the connected device via a wireless connection (“The output of the sensor 30 is provided to signal processor 34, such as Doppler signal processing detector, for processing and heartbeat detection. In turn, the signal digitization unit 36 digitizes the signal, such as through an analog to digital converter (ADC)… communication network 56, such as the internet or telephone network, couples the device to a server 62, preferably a secure data server. A user interface 64 optionally permits remote patient monitoring” [0068]; “The wireless communication paths are low power communications” [0069]); and
one or both of the patient-worn probe controller assembly and the patient-worn probe transducer assembly comprises a battery configured to provide power for the wearable ultrasound probe (“The device is powered by two standard AAA batteries” [0073]).
Regarding claim 6, Roham teaches wherein each of the patient- worn probe transducer assembly and the patient-worn probe controller assembly is configured to be attached to a patient via a patient attachment mechanism comprising: fixation adhesive, a strap, and/or a harness (see reproduced fig. 1 below).
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Regarding claim 7, Roham teaches comprising one or more non- ultrasound sensors, wherein each of the one or more non-ultrasound sensors is communicatively coupled to the at least one control processor and is provided (see re-produced Figs. 5-6 below):
in the first housing of the patient-worn probe transducer assembly (see fig. 5);
in the second housing of the patient-worn probe controller assembly; and/or in a third housing of a patient-worn sensor electronics assembly (see re-produced Figs. 5-6 below).
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Regarding claim 8, Roham teaches the one or more non-ultrasound sensors comprises an electrocardiogram (ECG) sensor operable to acquire ECG signals (“[0026] The sensing component of the device includes sensors and short-range wireless interface and is worn by pregnant mother. The fetal heartbeat is detected using either ultrasound Doppler (detecting movement of fetus heart), sound microphones (detecting sound of fetus heart) or ECG sensors (detecting ECG of fetus heart).” [0026]); and
the at least one control processor is configured to provide the control signals communicated to the patient-worn probe transducer assembly for triggering a timing of ultrasound data acquisition based on the ECG signals (“The resulting signals are processed and transmitted out to the gateway, using short range wireless interface or a wired connection.” [0026]).
Regarding claim 9, Roham teaches wherein:
the one or more non-ultrasound sensors comprises a respiration sensor operable to acquire respiration sensor signals (“measure heart rates from ECG signals, gait parameters such as step rates from motion sensors, and respiration rate from photoplethysmograph (PPG) sensors” [0127]); and
the at least one control processor is configured to provide the control signals communicated to the patient-worn probe transducer assembly for triggering a timing of ultrasound data acquisition and/or a targeted location of the ultrasound data acquisition based on the respiration sensor signals, wherein the targeted location of the ultrasound data acquisition is one of a plurality of targeted locations, each of the plurality of targeted locations corresponding with a respiratory phase identified by the respiration sensor signals (“signal processing techniques for the ultrasound signals with a high computational demand, a signal processing model transforms sensor readings …fetal heart rate monitoring and an application where the algorithms are used for Cardiotocography” [0029]; “comparing the subject unit and a standard cardiotocograph. The upper portion shows the fetal heart rate in beats per minute comparing the results of a standard cardiotocograph with the output of the instant inventions. The bottom portion shows the contraction percentage from a toco transducer. Both graphs are as a function of time in the same scale” [0132]).
Regarding claim 10, Roham teaches wherein:
the one or more non-ultrasound sensors comprises a pulse oximeter sensor operable to acquire local pulse oximeter sensor signals (“monitoring kit can also include a pulse oxymeter” [0033]); and
the at least one control processor is configured to provide the control signals communicated to the patient-worn probe transducer assembly for gating ultrasound data acquisitions based on the local pulse oximeter sensor signals (“this technique can be used to measure heart rates from ECG signals, gait parameters such as step rates from motion sensors, and respiration rate from photoplethysmograph (PPG) sensors” [0127]).
Regarding claim 11, Roham teaches wherein the one or more non- ultrasound sensors comprises: a motion sensor operable to acquire patient posture sensor signals for flagging unreliable ultrasound data and/or determining motion information (“measure heart rates from ECG signals, gait parameters such as step rates from motion sensors” [0127]);
a temperature sensor operable to acquire temperature sensor signals for determining temperature information; and/or a blood pressure sensor operable to acquire blood pressure sensor signals for determining blood pressure information (“Temperature sensors and accelerometers are among other possibilities, e.g., in a wearable, adhesive patch, one or more accelerometers can additionally capture the activity level of the person to help in additional assessment of health and wellbeing” [0080]; “the output of the fetal monitor (toco) 122, blood pressure and blood glucose monitors 124, and urine protein output 126. ” [0131]).
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Majida et al (Interobserver repeatability of three- and four-dimensional transperineal ultrasound assessment of pelvic floor muscle anatomy and function, Ultrasound Obstet Gynecol 2009; 33: 567–573).
Regarding claim 2, Roham teaches all the claimed limitations except for ultrasound probe being 4D probe.
However, in the same field of endeavor, Majida teaches using three- and four-dimensional (3D and 4D) transperineal ultrasound (abst). The technical improvement of three- andfour-dimensional (3D and 4D) transperineal ultrasonography, a new diagnostic tool has become available (intro).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with ultrasound probe being 4D probe as taught by Majida because 4D transperineal ultrasound could be a reliable method for obtaining additional information on the functional anatomy of the pubovisceral muscle during rest and contraction in women (conclusion of Majida)
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Tai et al (US 20060241459 A1).
Regarding claim 4, Roham teaches all the claimed limitations except for wherein the housing is a strain relief.
However, in the same field of endeavor, Tai teaches transducer array is interconnected to the main 200 cable through a strain relief located at the back of the housing 2. This strain relief would be glued to the jacket of the main cable and would have enough flexibility to the material to provide relief of pressures incurred from the bending of the main cable. The function of the strain relief is to protect the cable interface along the housing [0116].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Tai because relief of pressures incurred from the bending of the main cable to protect the cable interface along the housing ([0116] of Tai).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Lewis (US20120283605).
Regarding claim 5, Roham teaches all the claimed limitations except for probe processor comprises an Application-Specific Integrated Circuit (ASIC).
However, in the same field of endeavor, Lewis teaches portable ultrasound system that can be used for a wide range of ultrasound applications. The portable ultrasound system includes an energy generating module operative to generate a driving signal that can be transformed into ultrasonic energy (abst). The portable ultrasound system and the low-profile ultrasound transducer of the present invention, Application Specific Integrated Circuit (ASIC) technology can be employed [0105].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with ASIC as taught by Lewis because it would help overcoming these and other deficiencies in the art ([0005] of Lewis).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
The applicant argues the following;
Regarding independent claim 1, the Applicant respectfully submits that Roham at least fails to disclose, suggest, or teach, for example, "A wearable ultrasound probe comprising: a patient-worn probe transducer assembly comprising transducer elements disposed in a first housing, the transducer elements configured to transmit ultrasound beams and convert received echoes to electrical signals in response to control signals; and a patient-worn probe controller assembly comprising at least one control processor disposed in a second housing, the at least one control processor communicatively coupled to a connected device, the at least one control processor communicatively coupled to the patient-worn probe transducer assembly via a wired connection, the at least one control processor configured to provide the control signals to the patient-worn probe transducer assembly for controlling ultrasound data acquisition."
However, in addition to the above rejections, it is also noted that Roham discloses “in FIG. 7, which can be assembled [i.e., housed, maybe in patch like pad as noted in [0081]] in a variety of ways. The components are (a) a passive strain gage (“toco” sensor) used for contraction monitoring; and (b) a Fetal Heart Rate (FHR) monitor based on continuous-wave (CW) Doppler ultrasound. The FHR monitor includes analog signal processing for both sensor modalities, a Bluetooth transceiver, and a low-cost microcontroller, which provides digital signal processing (DSP) and system control, 8 bit analog-to-digital conversion, and communication with the Bluetooth transceiver” [0082]. Roham further discloses “A second, identical FHR monitor can be included as illustrated in FIG. 8 to monitor the FHR of a twin” [0082]. This is shown in below re-produced fig. 8
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The wiring connections are shown in above fig. 8 above between the two identical FHR monitors and the overall system. This is further explained in “circuit design, the FHR monitor is controlled using a low-cost, 8-bit microcontroller that includes all the analog-to-digital conversion, timing, and indicator drive required by the monitor, as illustrated in FIG. 9” [0089]. Further, for more connections and controller providing control signal see figs. 9-10 and 13 as well as the associated pars.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272 7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
