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 office action is in response to the communications filed on 03/18/2026, concerning Application No. 18/910,226. The amendments to the claims filed on 03/18/2026 are acknowledged. Presently, claims 1-20 remain pending.
Claim Objections
Claims 1, 5, and 12-14 are objected to because of the following informalities:
Claim 1, line 12, the limitation “the array of ultrasound sensors” should be changed to “the array of ultrasound transducers”;
Claim 5, line 2, the limitation “a second backing payer” should be changed to “a second backing layer”;
Claim 12, line 2, the limitation “configured to detect muscle movements” should be changed to “configured to detect the muscle movement signals”
Claim 13, line 13, the limitation “the array of ultrasound sensors” should be changed to “the array of ultrasound transducers”; and
Claim 14, line 2, the limitation “a piezo layer comprising PZT-5A” should be changed to “the piezo layer comprising PZT-5A”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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, 5-14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xue et al. (NPL: Xue et al., “Development of a wearable ultrasound transducer for sensing muscle activities in assistive robotics applications: In vivo study”, 2022 IEEE International Ultrasonics Symposium (IUS), Venice, Italy, 10-13 Oct. 2022, pp. 1-4, doi: 10.1109/IUS54386.2022.9958535; of record, a copy of which was provided by the Examiner on 12/18/2025 and herein used for citation, with publication date of 01/12/2023 and earliest publicly available date of 10/10-10/13/2022, hereinafter Xue).
Examiner note: The applied reference Xue has common applicants with the instant application. However, based upon the earliest public availability date of the applied reference Xue (IEEE Symposium 10/10-10/13/2022), it constitutes prior art under 35 U.S.C. 102(a)(1) because the public availability date of the applied reference Xue is outside of the one-year grace period from which the instant application was filed, which is 10/09/2024. Examiner emphasizes that the instant application’s provisional application does not support each and every limitation in the independent claims (i.e., the provisional application does not seem to provide support for the limitations “whereby the wearable ultrasound sensor is configured to detect muscle movement signals” (emphasis added) of independent claim 1, “A system comprising: a wearable ultrasound sensor […] and a controller in electrical communication with the array of ultrasound transducers of the wearable ultrasound sensor, the controller configured to collect and interpret signals from the array of ultrasound transducers in response to a muscle activity” (emphasis added) of independent claim 13, “providing a matching layer and an active layer comprising a piezo layer” (emphasis added) of independent claim 16, etc.), and therefore, the effective filing date of the instant application is not the filing date of the provisional application (10/09/2023), but rather the filing date of the non-provisional (10/09/2024), in which case the applied reference Xue does qualify as prior art under 35 U.S.C. 102(a)(1).
Regarding claim 1, Xue discloses a wearable ultrasound sensor configured to detect muscle activities (see, e.g., Page 1, Abstract, lines 7-14, “Ultrasound (US) imaging is an effective method for measuring muscle activity. […] this work aims to develop a novel wearable US device for detecting muscle activities”, and Figs. 1(a) and 1(b)), the wearable ultrasound sensor comprising:
an array of ultrasound transducers (see, e.g., Page 2, col. 1, lines 15-18, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate”, and Figs. 1(a) and 1(b)), wherein each ultrasound transducer comprises:
a matching layer on a top side (see, e.g., Page 2, col. 1, lines 28-31, “The lapped active layer was attached to an acoustic matching layer with a thickness of 0.25 mm made of aluminum oxide/epoxy with a particle size of 50 nm using epoxy”, and Figs. 1(a) and 1(b), where the matching layer is shown to be positioned on the top side of the ultrasound transducer array);
an active layer adjacent the matching layer (see, e.g., Page 2, col. 1, lines 26-29, “As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm. The lapped active layer was attached to an acoustic matching layer”, and Figs. 1(a) and 1(b), where the active layer is shown to be positioned below and adjacent to the matching layer), wherein the active layer is a piezo layer (see, e.g., Page 2, col. 1, lines 26-28, “As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm”); and
an epoxy bonding material interspaced between each of the matching layer and the active layer (see, e.g., Page. 2, col. 1, lines 38-41, “Wearable US transducer fabrication consisted of four steps, as shown in Fig. 3(b). In the first step, the matching layer, active layer, and two backing layers were stacked and bonded using EpoTek 301 epoxy”, and Fig. 1(b), where step 1 of the fabrication process is shown to include stacking and bonding each layer to one another using an epoxy material),
wherein the array of ultrasound transducers is surrounded by a filling (see, e.g., Page 2, col. 1, lines 15-18, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate”, and Page 2, col. 1, lines 51-55 to col. 2, lines 1-2, “As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Figs. 1(a) and 1(b)) that forms a flexible substrate within which the array of ultrasound sensors is arranged (see, e.g., Page 2, col. 1, lines 49-55 to col. 2, lines 1-2, “Upon completion of the wire connection, the elements were coated with parylene-C (SCS Labcoter, PDS 2010, SCS, Indianapolis, IN) for protection. As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Fig. 1(b)),
whereby the wearable ultrasound sensor is configured to detect muscle movement signals (see, e.g., Page 2, col. 1, lines 24-28, “In order to detect muscle movements, each element had a center frequency of 10 MHz due to the depth of penetration required. As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm”, and Page 3, col. 1, lines 10-13, “The wearable transducers were attached to the subject’s forearm FCR to detect muscle activity as the subject went from relaxed to clenched fist in 2.5 seconds.”).
Regarding claim 3, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses wherein the matching layer comprises aluminum oxide and epoxy (see, e.g., Page 2, col. 1, lines 28-31, “The lapped active layer was attached to an acoustic matching layer with a thickness of 0.25 mm made of aluminum oxide/epoxy with a particle size of 50 nm using epoxy”), the piezo layer comprises PZT-5A (see, e.g., Page 2, col. 1, lines 26-28, “As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm”), and the filling forming the flexible substrate comprises a PDMS filling (see, e.g., Page 2, col. 1, lines 15-18, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate”, and Page 2, col. 1, lines 51-55 to col. 2, lines 1-2, “As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Figs. 1(a) and 1(b)).
Regarding claim 5, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses the wearable ultrasound sensor further comprising a first backing layer adjacent the active layer (see, e.g., Page 2, col. 1, lines 32-35, “On the back side of the active layer, the electrically conductive epoxy (E-Solder 3022, Von-Roll Inc., Cleveland, OH, USA) was applied as the first backing layer with a thickness of 0.28 mm”, and Figs. 1(a) and 1(b), where the first backing layer is shown to be positioned below and adjacent to the active layer) and a second backing layer adjacent the first backing layer (see, e.g., Page 2, col. 1, lines 35-37, “As an additional backing layer, epoxy mixed with tungsten particles was cast on top of the first backing layer”, and Figs. 1(a) and 1(b), where the second backing layer is shown to be positioned below and adjacent to the first backing layer); wherein the first backing layer comprises E-solder 3022 (see, e.g., Page 2, col. 1, lines 32-35, “On the back side of the active layer, the electrically conductive epoxy (E-Solder 3022, Von-Roll Inc., Cleveland, OH, USA) was applied as the first backing layer with a thickness of 0.28 mm”) and the second backing layer comprises tungsten and epoxy (see, e.g., Page 2, col. 1, lines 35-37, “As an additional backing layer, epoxy mixed with tungsten particles was cast on top of the first backing layer”).
Regarding claim 6, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses the wearable ultrasound sensor further comprising a wire connection to each of a top side of the active layer and a bottom side of the active layer (see, e.g., Page 2, col. 1, lines 45-49, “E-Solder 3022 epoxy was used to implement the ground connection on the electrode placed on the backside of the active layer. With conductive epoxy, the positive cable was carefully bonded to the electrode on the front side of the active layer”).
Regarding claim 7, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses wherein the array of ultrasound transducers comprises 16 ultrasound transducers (see, e.g., Page 1, Abstract, lines 13-15, “this work aims to develop a novel wearable US device for detecting muscle activities. In specific, a 16-element 10 MHz flexible sparse array was designed, fabricated, and characterized”, and Page 2, col. 1, lines 15-18, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate”, and Figs. 1(a) and 1(b)).
Regarding claim 8, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses the wearable ultrasound sensor further comprising a data acquisition system in electrical communication with each of the ultrasound transducers of the array of ultrasound transducers, the data acquisition system configured to collect data from the array of ultrasound transducers during a muscle activation or muscle detection operation (see, e.g., Page 2, col. 1, lines 42-45, “The third step is that each element was individually wired to a coaxial cable to reduce the possibility of wire damage during bending or extended motion”, and Page 3, col. 1, lines 18-25, “The wearable transducer was driven by a customized A-mode US system with a frame rate of 500 Hz and a sampling rate of 25 MHz while the forearm was moved. […] We used the RF signal at the initial relaxation location as the reference signal, and the muscle displacement was determined at 0.5 second intervals”, and Figs. 3(a) and 3(b), where the claimed data acquisition system corresponds to the disclosed “A mode ultrasound system”, which is shown to be in electrical communication with each of the transducers of the array).
Regarding claim 9, Xue discloses the wearable ultrasound sensor of claim 8, as set forth above. Xue further discloses the wearable ultrasound sensor further comprising a controller in electrical communication with the data acquisition system, the controller configured for processing signals from the array of ultrasound transducers (see, e.g., Page 3, col. 1, lines 18-22, “The wearable transducer was driven by a customized A-mode US system with a frame rate of 500 Hz and a sampling rate of 25 MHz while the forearm was moved. All the signal and image processing were performed using MATLAB (R2020b, The MathWorks, Natick, Massachusetts, USA)”, and Fig. 3(a), where the claimed controller corresponds to the disclosed “PC” in which “RF signals [are] processed using MATLAB”).
Regarding claim 10, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses wherein the array of ultrasound transducers is configured to be coupled to at least a portion of a muscle grouping of a user (see, e.g., Page 1, Abstract, lines 13-17, “this work aims to develop a novel wearable US device for detecting muscle activities. In specific, a 16-element 10 MHz flexible sparse array was designed, fabricated, and characterized. The feasibility of monitoring muscle activity in different regions was demonstrated by an in vivo human experiment”, and Page 2, col. 1, lines 15-20, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate. Real-time analysis of forearm flexor carpi radialis (FCR) muscle activity was carried out using this array in vivo”).
Regarding claim 11, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses wherein a thickness of each ultrasound transducer is less than 1.5 mm (see, e.g., Page 2, col. 1, lines 38-42, “Wearable US transducer fabrication consisted of four steps, as shown in Fig. 3(b). In the first step, the matching layer, active layer, and two backing layers were stacked and bonded using EpoTek 301 epoxy. The bonded stacks were diced into elements of 1.4 mm lateral size as a second step”, and Page 4, col. 1, lines 13-15 to col. 2, lines 1-3, “In this study, the fabrication procedure for incorporating PZT-5A elements into PDMS substrates was demonstrated, resulting in a flexible and wearable US transducer array. The 4×4 array consists of 16 elements and the size of each element was 1.4 mm x 1.4 mm with a thickness of about 1.2 mm”).
Regarding claim 12, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue further discloses wherein the array of ultrasound transducers has a center frequency of 10 MHz configured to detect muscle movements (see, e.g., Page 2, col. 1, lines 24-26, “In order to detect muscle movements, each element had a center frequency of 10 MHz due to the depth of penetration required”).
Regarding claim 13, Xue discloses a system comprising: a wearable ultrasound sensor configured to detect muscle activities (see, e.g., Page 1, Abstract, lines 7-14, “Ultrasound (US) imaging is an effective method for measuring muscle activity. […] this work aims to develop a novel wearable US device for detecting muscle activities”, and Figs. 1(a) and 1(b)), the wearable ultrasound sensor comprising:
an array of ultrasound transducers (see, e.g., Page 2, col. 1, lines 15-18, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate”, and Figs. 1(a) and 1(b)), wherein each ultrasound transducer comprises:
a matching layer on a top side (see, e.g., Page 2, col. 1, lines 28-31, “The lapped active layer was attached to an acoustic matching layer with a thickness of 0.25 mm made of aluminum oxide/epoxy with a particle size of 50 nm using epoxy”, and Figs. 1(a) and 1(b), where the matching layer is shown to be positioned on the top side of the ultrasound transducer array);
an active layer adjacent the matching layer (see, e.g., Page 2, col. 1, lines 26-29, “As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm. The lapped active layer was attached to an acoustic matching layer”, and Figs. 1(a) and 1(b), where the active layer is shown to be positioned below and adjacent to the matching layer), wherein the active layer is a piezo layer (see, e.g., Page 2, col. 1, lines 26-28, “As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm”); and
an epoxy bonding material interspaced between each of the matching layer and the active layer (see, e.g., Page. 2, col. 1, lines 38-41, “Wearable US transducer fabrication consisted of four steps, as shown in Fig. 3(b). In the first step, the matching layer, active layer, and two backing layers were stacked and bonded using EpoTek 301 epoxy”, and Fig. 1(b), where step 1 of the fabrication process is shown to include stacking and bonding each layer to one another using an epoxy material),
wherein the array of ultrasound transducers is surrounded by a filling (see, e.g., Page 2, col. 1, lines 15-18, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate”, and Page 2, col. 1, lines 51-55 to col. 2, lines 1-2, “As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Figs. 1(a) and 1(b)) that forms a flexible substrate within which the array of ultrasound sensors is arranged (see, e.g., Page 2, col. 1, lines 49-55 to col. 2, lines 1-2, “Upon completion of the wire connection, the elements were coated with parylene-C (SCS Labcoter, PDS 2010, SCS, Indianapolis, IN) for protection. As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Fig. 1(b)); and
a controller in electrical communication with the array of ultrasound transducers of the wearable ultrasound sensor, the controller configured to collect and interpret signals from the array of ultrasound transducers in response to a muscle activity (see, e.g., Page 2, col. 1, lines 42-45, “The third step is that each element was individually wired to a coaxial cable to reduce the possibility of wire damage during bending or extended motion”, and Page 3, col. 1, lines 18-25, “The wearable transducer was driven by a customized A-mode US system with a frame rate of 500 Hz and a sampling rate of 25 MHz while the forearm was moved. All the signal and image processing were performed using MATLAB (R2020b, The MathWorks, Natick, Massachusetts, USA). We used the RF signal at the initial relaxation location as the reference signal, and the muscle displacement was determined at 0.5 second intervals”, and Figs. 3(a) and 3(b), where the claimed controller corresponds to the disclosed “PC” in which “RF signals [are] processed using MATLAB”).
Regarding claim 14, Xue discloses the system of claim 13, as set forth above. Xue further discloses wherein the active layer of the wearable ultrasound sensor is a piezo layer comprising PZT-5A (see, e.g., Page 2, col. 1, lines 26-28, “As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm”), and wherein the filling forming the flexible substrate comprises a PDMS filling (see, e.g., Page 2, col. 1, lines 15-18, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate”, and Page 2, col. 1, lines 51-55 to col. 2, lines 1-2, “As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Figs. 1(a) and 1(b)).
Regarding claim 16, Xue discloses a method of fabricating a wearable ultrasound sensor (see, e.g., Page 1, Abstract, lines 13-17, “this work aims to develop a novel wearable US device for detecting muscle activities. In specific, a 16-element 10 MHz flexible sparse array was designed, fabricated, and characterized. The feasibility of monitoring muscle activity in different regions was demonstrated by an in vivo human experiment”), the method comprising:
providing a matching layer and an active layer (see, e.g., Page 2, col. 1, lines 38-41, “Wearable US transducer fabrication consisted of four steps, as shown in Fig. 3(b). In the first step, the matching layer, active layer, and two backing layers were stacked and bonded using EpoTek 301 epoxy”, and Fig. 1(b)) comprising a piezo layer (see, e.g., Page 2, col. 1, lines 26-28, “As the active layer, a piezo ceramic plate PZT-5A was mechanically diced and lapped down to achieve a thickness of 0.2 mm”);
stacking the matching layer and the active layer using an epoxy to form a bonded stack (see, e.g., Page 2, col. 1, lines 38-41, “Wearable US transducer fabrication consisted of four steps, as shown in Fig. 3(b). In the first step, the matching layer, active layer, and two backing layers were stacked and bonded using EpoTek 301 epoxy”, and Fig. 1(b));
dicing the bonded stack into a plurality of ultrasound sensors including a first ultrasound sensor (see, e.g., Page 2, col. 1, lines 41-42, “The bonded stacks were diced into elements of 1.4 mm lateral size as a second step”, and Fig. 1(b));
coupling a wire to the first ultrasound sensor, the wire configured to relay data from the first ultrasound sensor to a data acquisition system or a controller (see, e.g., Page 2, col. 1, lines 42-49, “The third step is that each element was individually wired to a coaxial cable to reduce the possibility of wire damage during bending or extended motion. E-Solder 3022 epoxy was used to implement the ground connection on the electrode placed on the backside of the active layer. With conductive epoxy, the positive cable was carefully bonded to the electrode on the front side of the active layer”, and Fig. 1(b)); and
coating the plurality of ultrasound sensors with a protective material which, when cured, forms a flexible substrate within which the plurality of ultrasound sensors is arranged in an array (see, e.g., Page 2, col. 1, lines 49-55 to col. 2, lines 1-2, “Upon completion of the wire connection, the elements were coated with parylene-C (SCS Labcoter, PDS 2010, SCS, Indianapolis, IN) for protection. As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Fig. 1(b)).
Regarding claim 17, Xue discloses the method of claim 16, as set forth above. Xue further discloses wherein the wearable ultrasound sensor is configured for conforming and attaching to a skin surface of a mammal (see, e.g., Page 1, Abstract, lines 13-17, “this work aims to develop a novel wearable US device for detecting muscle activities. In specific, a 16-element 10 MHz flexible sparse array was designed, fabricated, and characterized. The feasibility of monitoring muscle activity in different regions was demonstrated by an in vivo human experiment”, and Page 2, col. 1, lines 15-20, “this study aims to develop a novel wearable US device, consisting of a 4×4 PZT-5A array transducer and biomedical-grade polydimethylsiloxane (PDMS) for the substrate. Real-time analysis of forearm flexor carpi radialis (FCR) muscle activity was carried out using this array in vivo”).
Regarding claim 18, Xue discloses the method of claim 16, as set forth above. Xue further discloses wherein the protective material is liquid PDMS that cures to form the flexible substrate (see, e.g., Page 2, col. 1, lines 49-55 to col. 2, lines 1-2, “Upon completion of the wire connection, the elements were coated with parylene-C (SCS Labcoter, PDS 2010, SCS, Indianapolis, IN) for protection. As a final step, the fabricated elements were attached to the round 3D printed mold and arranged into a 4 by 4 array. The PDMS was then poured into the 3D-printed mold to create the flexible substrate. The PDMS-filled mold was then transferred to the oven and maintained at 50 °C for six hours to complete the curing process”, and Fig. 1(b)).
Regarding claim 19, Xue discloses the method of claim 16, as set forth above. Xue further discloses wherein the first ultrasound sensor of the plurality of ultrasound sensors has a width less than 1.5 mm and a thickness less than 1.5 mm (see, e.g., Page 2, col. 1, lines 38-42, “Wearable US transducer fabrication consisted of four steps, as shown in Fig. 3(b). In the first step, the matching layer, active layer, and two backing layers were stacked and bonded using EpoTek 301 epoxy. The bonded stacks were diced into elements of 1.4 mm lateral size as a second step”, and Page 4, col. 1, lines 13-15 to col. 2, lines 1-3, “In this study, the fabrication procedure for incorporating PZT-5A elements into PDMS substrates was demonstrated, resulting in a flexible and wearable US transducer array. The 4×4 array consists of 16 elements and the size of each element was 1.4 mm x 1.4 mm with a thickness of about 1.2 mm”).
Regarding claim 20, Xue discloses the method of claim 16, as set forth above. Xue further discloses the method further comprising: providing the controller coupled to and in electrical communication with the plurality of ultrasound sensors, the controller configured to collect muscle movement signals from the plurality of ultrasound sensors (see, e.g., Page 2, col. 1, lines 42-45, “The third step is that each element was individually wired to a coaxial cable to reduce the possibility of wire damage during bending or extended motion”, and Page 3, col. 1, lines 18-25, “The wearable transducer was driven by a customized A-mode US system with a frame rate of 500 Hz and a sampling rate of 25 MHz while the forearm was moved. All the signal and image processing were performed using MATLAB (R2020b, The MathWorks, Natick, Massachusetts, USA). We used the RF signal at the initial relaxation location as the reference signal, and the muscle displacement was determined at 0.5 second intervals”, and Figs. 3(a) and 3(b), where the claimed controller corresponds to the disclosed “PC” in which “RF signals [are] processed using MATLAB”).
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.
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Xue (NPL), as applied to claims 1 and 13 above, in view of Chitnis et al. (US 2024/0324995 A1, of record, with effectively filed date 03/30/2023, hereinafter Chitnis).
Regarding claim 2, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue does not specifically disclose wherein the wearable ultrasound sensor is also configured as a wearable functional electrical stimulation (FES) electrode.
However, in the same field of endeavor of wearable ultrasound devices, Chitnis discloses wherein the wearable ultrasound sensor is also configured as a wearable functional electrical stimulation (FES) electrode (see, e.g., Para. [0063], “The disclosed device may be used for any suitable ultrasound application, including applications benefitting from a wearable ultrasound device. One example is the dynamic assessment of musculoskeletal tissues using a compact, portable, and wearable ultrasound device, for example using the device in M-mode and/or 2D brightness-mode (B-mode). Another example is robust myography during physical activity and movement. For example, the wearable application of the device enables real-time examination of muscle quality, tissue composition fascial gliding, cross-sectional area, fascicle pennation angle, and contraction velocity, for example during aerobic exercise or weight training. Such an application in some aspects can guide training or recovery from musculoskeletal injury”, and Para. [0064], “Kinematics and kinetics can also be observed as a means for characterizing muscle tissue properties. For instance, the ultrasound device can be used to correlate joint angle and joint torque during functional electric stimulation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensor of Xue by including wherein the wearable ultrasound sensor is also configured as a wearable functional electrical stimulation (FES) electrode, as disclosed by Chitnis. One of ordinary skill in the art would have been motivated to make this modification in order to observe kinematics and kinetics as a means for characterizing muscle tissue properties and correlating joint angle and joint torque during functional electric stimulation, as recognized by Chitnis (see, e.g., Para. [0063-0064]).
Regarding claim 15, Xue discloses the system of claim 13, as set forth above. Xue does not specifically disclose wherein the wearable ultrasound sensor is also configured as a wearable functional electrical stimulation (FES) electrode, and the controller is configured to send electrical stimulation signals to the array of ultrasound transducers of the wearable ultrasound sensor.
However, in the same field of endeavor of wearable ultrasound devices, Chitnis discloses wherein the wearable ultrasound sensor is also configured as a wearable functional electrical stimulation (FES) electrode, and the controller is configured to send electrical stimulation signals to the array of ultrasound transducers of the wearable ultrasound sensor (see, e.g., Para. [0063], “The disclosed device may be used for any suitable ultrasound application, including applications benefitting from a wearable ultrasound device. One example is the dynamic assessment of musculoskeletal tissues using a compact, portable, and wearable ultrasound device, for example using the device in M-mode and/or 2D brightness-mode (B-mode). Another example is robust myography during physical activity and movement. For example, the wearable application of the device enables real-time examination of muscle quality, tissue composition fascial gliding, cross-sectional area, fascicle pennation angle, and contraction velocity, for example during aerobic exercise or weight training. Such an application in some aspects can guide training or recovery from musculoskeletal injury”, and Para. [0064], “Kinematics and kinetics can also be observed as a means for characterizing muscle tissue properties. For instance, the ultrasound device can be used to correlate joint angle and joint torque during functional electric stimulation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Xue by including wherein the wearable ultrasound sensor is also configured as a wearable functional electrical stimulation (FES) electrode, and the controller is configured to send electrical stimulation signals to the array of ultrasound transducers of the wearable ultrasound sensor, as disclosed by Chitnis. One of ordinary skill in the art would have been motivated to make this modification in order to observe kinematics and kinetics as a means for characterizing muscle tissue properties and correlating joint angle and joint torque during functional electric stimulation, as recognized by Chitnis (see, e.g., Para. [0063-0064]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xue (NPL), as applied to claim 1 above, in view of Xu et al. (US 2024/0206848 A1, with effectively filed date 05/11/2021, hereinafter Xu).
Regarding claim 4, Xue discloses the wearable ultrasound sensor of claim 1, as set forth above. Xue does not specifically disclose wherein the flexible substrate has a stretchability of greater than 170% in tensile strain.
However, in the same field of endeavor of wearable ultrasound devices, Xu discloses wherein the flexible substrate has a stretchability of greater than 170% in tensile strain (see, e.g., Para. [0049], “To individually address each element in such a compact array, we made high-density multilayered stretchable electrodes based on a composite of eutectic gallium-indium liquid metal and SEBS. The composite is highly conductive and easy to pattern (see FIG. 1B, which shows the resistance of the liquid metal composite electrode as a function of uniaxial tensile strain. The stretchability of the electrode is around 750%”, and Para. [0152], “This liquid metal electrode exhibited high conductivity, exceptional stretchability, and negligible resistance change under tensile strain (FIGS. 1B and 1C; fig. S5). The initial resistance at 0% strain was 1.74Ω (corresponding to a conductivity of ˜11800 S/m), comparable to reported studies. The electrode could maintain a relatively constant resistance until stretched beyond ˜266%. The resistance then gradually increased with strain until the electrode reached the ˜750% failure strain (FIG. 1C, fig. S5)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensor of Xue by including wherein the flexible substrate has a stretchability of greater than 170% in tensile strain, as disclosed by Xu. One of ordinary skill in the art would have been motivated to make this modification in order to provide exceptional stretchability and negligible resistance change under tensile strain, as recognized by Xu (see, e.g., Para. [0049] and [0152]).
Response to Arguments
Applicant's argument, see Remarks filed 03/18/2026, have been fully considered but they are not persuasive.
Regarding Xue et al. (NPL, of record), Applicant argues that Xue et al. is disqualified as prior art under §102(a)(1) by the corresponding §102(b)(1)(A) exception.
Examiner respectfully disagrees and emphasizes that the instant application’s provisional application does not support each and every limitation in the independent claims (i.e., the provisional application does not seem to provide support for the limitations “whereby the wearable ultrasound sensor is configured to detect muscle movement signals” (emphasis added) of independent claim 1, “A system comprising: a wearable ultrasound sensor […] and a controller in electrical communication with the array of ultrasound transducers of the wearable ultrasound sensor, the controller configured to collect and interpret signals from the array of ultrasound transducers in response to a muscle activity” (emphasis added) of independent claim 13, “providing a matching layer and an active layer comprising a piezo layer” (emphasis added) of independent claim 16, etc.), and therefore, the effective filing date of the instant application is not the filing date of the provisional application (10/09/2023), but rather the filing date of the non-provisional (10/09/2024), in which case the applied reference Xue does qualify as prior art under 35 U.S.C. 102(a)(1).
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 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.
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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