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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 19 September 2025 has been entered.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1, lines 14-16 recite “upon detection of bioelectric signal in target site via the EP module upon detection of a bioelectric signal and/or electrophysiological parameter at the target site”, It appears from the arguments and the specification that the limitation has been repeated, for examination purposes the newly added amendment will be interpreted to be read as “upon detection of a bioelectric signal and/or electrophysiological parameter at the target site”
Appropriate correction is required.
Response to Amendment
This Office Action is responsive to the amendment filed 19 September 2025. As directed by the amendment: Claims 1, 3-4, 6-8, 11, and 14-15 have been amended and no claims have been added or cancelled. Thus, claims 1-17 and 19-20 are pending in this application.
Response to Arguments
Response to Arguments Regarding 35 USC § 112
Applicant’s amendments to claim 17 has overcome the 112(b) rejection previously set forth in the Non-Final Office Action mailed 09/27/2024.
Response to Arguments Regarding 35 USC § 102/103
Applicant’s arguments, see pg. 8-10 of Remarks, filed 19 September 2025, with respect to the rejection(s) of claim(s) 1 under Alford in view of Kang have been fully considered and are partially persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ramamurthy (US 2019/0183457 A1) and (alternative to Kang) in view of Walker et al. (US Patent 6,690,958 B1).
Applicant argues Alford is an entirely distinct system as Alford’s transducer use is for emitting energy into the body to achieve a physiological effect and does not receive any acoustic signal in return, nor does it generate any form of imaging.
In response to applicant's argument that Alford is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Alford teaches that “a first set of transducers may be configured to emit ultrasound energy and a second set of transducers may be configured to receive reflected ultrasound energy to image anatomical structures." ([0039]), that the “wearable ultrasound device 30 may additionally, or alternatively, be configured to detect reflected ultrasound waves for imaging physiological structures which may include generating information related to structure dimensions and distances between structures” ([0087], [0042]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. “cross-analysis with other signals” and “only if certain physiological conditions are met (e.g., specific activation levels or signal combination), the system triggers image acquisition…decision-based control architecture”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Specifically, the concept of activation levels and signal combination for triggering image is not positively recited rather the ultrasound image obtainment is triggered by detection of bioelectric signal and/or electrophysiological parameter at the target site not a signal combination or specific activation levels.
However, Examiner does agree that Alford teaches physiological signals, such as EMG, as a simple trigger to begin therapeutic ultrasound delivery and not as a trigger for image acquisition, and therefore has instead used Ramamurthy (US 2019/0183457 A1) which teaches an ultrasound imaging device to teach the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of a bioelectric signal and/or electrophysiological parameter at the target site ([0107] “Ultrasound machine 400 may further comprise a trigger processing circuit 460 to receive physiological signals…an electrocardiogram (ECG) machine is connected to trigger processing circuit 460 through port 461. Trigger processing circuit 460 may process received physiological signals such as ECG signals in many way…A triggering circuit or system may also be included within trigger processing circuit 460. The triggering circuit may generate triggers in response to triggering events indicated in the received physiological signal. These triggers may be routed to controller 410 within ultrasound machine 400. If a triggering event occurs, trigger processing circuit 460 will receive an input through port 461 and transmit a signal to controller 410. Controller 410 may be programmed to start imaging when such a signal is received from trigger processing circuit 460. Controller 410 may be further programmed to image only for a certain set amount of time that may itself be programmable.”, [0167]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Alford with the teachings of Ramamurthy to have the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of a bioelectric signal and/or electrophysiological parameter at the target site, as these prior art references are directed to ultrasound devices. One would be motivated to do this to obtain the most qualitative and relevant images.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It should be noted that Alford was used to teach the ultrasound imaging concepts to construct the anatomical images, Kang has been used to teach a NIRS module for monitoring oxygenation status and/or biochemical measurements of the target site that would be combined with Alford’s ultrasound imaging system which uses conventional ultrasound, based on the emission and reflection of mechanical waves to construct anatomical images ([0039], [0042], and [0087]).
Without, acquiescing to the arguments and merely to expedite prosecution of the application Examiner has also alternatively used Walker et al. (US Patent 6,690,958 B1) to teach the limitation of wherein a near-infrared spectroscopy (“NIRS”) module (near infrared spectrophotometer 400) positioned on the resilient substrate in electrical communication with the controller and configured for monitoring oxygenation status and/or biochemical measurements of the target site (Column 2, lines 22-24: “A diagnostic apparatus includes a near infrared spectrophotometer and an ultrasound transducer that operate in combination to improve diagnostic measurements”, Column 10 – Column 12: the spectrophotometer measurement, blood flow measurement, and tissue blood gas measurement, Column 13, lines 22-25: “Combined optical-acoustic diagnostic apparatus 600 is an example of a near infrared spectrophotometer (NIRS) that is useful for tissue oxygenation monitoring.” )
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Alford and Ramamurthy to incorporate the teachings of Walker to have a near-infrared spectroscopy (“NIRS”) module (near infrared spectrophotometer 400) positioned on the resilient substrate in electrical communication with the controller and configured for monitoring oxygenation status and/or biochemical measurements of the target site, as these prior art references and the instant application are directed to diagnostic apparatus that utilizing ultrasound. One would be motivated to include NIRS to improve diagnostic measurements, as recognized by Walker(Abstract).
Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “Active control architecture…a controller analyzes multiple inputs, compares thresholds, and activates the imaging module only when predefined conditions are met”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). There is no positive recitation of multiple inputs, thresholds, or predefined conditions in the claims.
Therefore, claims 1-2, 9, 13, 17, and 20 are rejected as described in detail below.
No additional specific arguments were presented with previous 35 U.S.C. 103 rejections of dependent claims 3-6, 8, 10, 11, 12, 14, 14-16, and 19-20, nor specifically with respect to the previously cited Xu, Sonnenshein, Xu’204, Hazra, Song, Kasahara, Jiang, Yamamoto, and Maharbiz references.
Therefore, claims 3-6, 8, 10, 11, 12, 14, 14-16, and 19-20 remain rejected as described in detail below.
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.
Claim(s) 1-2, 9, 13, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford et al. (US 2019/0269942 A1, previously cited), hereinafter Alford in view of Ramamurthy (US 2019/0183457 A1), hereinafter Ramamurthy further in view of Kang et al. (US 2024/0122530 A1, previously cited), hereinafter Kang, or alternatively further in view of Walker et al. (US Patent 6,690,958 B1), hereinafter Walker .
Regarding Claim 1, Alford discloses a wearable ultrasound apparatus positionable on a target site of a user's body, and the apparatus comprising (Fig. 2A wearable ultrasound device 50):
an ultrasound module configured for obtaining an ultrasound image of the target site, the ultrasound module comprising ([0039] “to receive reflected ultrasound energy to image anatomical structures”):
an ultrasound transducer (Fig 2A, ultrasound transducers 56) positioned on an at least one resilient substrate (Figure 2A, flexible interconnect element 54, [0060]), the at least one ultrasound transducer comprising an at least one sensor ([0067] “ultrasound transducers 56 may additionally…include piezoelectric micro machines ultrasonic transducers (PMUTs)”);
an conductive layer positioned in electrical communication with the at least one sensor ([0067] “In examples in which power sources 58 and ultrasound transducers 56 are attached, the ultrasound material may be glued or otherwise bonded to the surface of power source 58. In some examples, a metallic housing of power source 58 may be part of an electrical circuit of wearable ultrasound device 50”); and
an ultrasound transceiver in electrical communication with the sensor; ([0053] “interface device 34 is configured to communicate e.g., via a wireless connection with wearable ultrasound device…may also be configured to communicate, e.g., via a wired or wireless connection, with implanted or wearable sensors”)
an electrophysiological ("EP") module (sensors 76) positioned on the at least one resilient substrate and configured for detecting bioelectric signals of the target site ([0073] “in which wearable ultrasound device 60 is configured to sense physiological events wearable ultrasound device may include one or more sensors”, [0043] “the physiological event may include…electromyography (EMG) information, or a heart rate of patient”) ;
an controller in electrical communication (processing circuitry 70) with each of the ultrasound module and EP module via the conductive layers (Figure 3), the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site ([0071] “Processing circuitry 70 are configured to control ultrasound transducers 62 to deliver ultrasound energy, e.g., for a therapeutic or an imaging purpose”).
Although Alford does not explicitly teach a conductive layer positioned in electrical communication with the at least one sensor, Alford does teach a power supply possessing a metallic housing which is attached to the transducer (that could be a piezoelectric ultrasound transducer) and plays a part in the electric circuit. It is inherent that a metal can act as a conductor, therefore the Examiner interprets the metallic housing attached to the transducer as the conductive layer.
Alford fails to disclose the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of a bioelectric signal and/or electrophysiological parameter at the target site and a near-infrared spectroscopy ("NIRS") module positioned on the resilient substrate, in electrical communication with the controller, and configured for monitoring oxygenation status and/or biochemical measurements of the target site.
However, Ramamurthy teaches an ultrasound imaging device wherein the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of a bioelectric signal and/or electrophysiological parameter at the target site ([0107] “Ultrasound machine 400 may further comprise a trigger processing circuit 460 to receive physiological signals…an electrocardiogram (ECG) machine is connected to trigger processing circuit 460 through port 461. Trigger processing circuit 460 may process received physiological signals such as ECG signals in many way…A triggering circuit or system may also be included within trigger processing circuit 460. The triggering circuit may generate triggers in response to triggering events indicated in the received physiological signal. These triggers may be routed to controller 410 within ultrasound machine 400. If a triggering event occurs, trigger processing circuit 460 will receive an input through port 461 and transmit a signal to controller 410. Controller 410 may be programmed to start imaging when such a signal is received from trigger processing circuit 460. Controller 410 may be further programmed to image only for a certain set amount of time that may itself be programmable.”, [0167]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Alford with the teachings of Ramamurthy to have the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of a bioelectric signal and/or electrophysiological parameter at the target site, as these prior art references are directed to ultrasound devices. One would be motivated to do this to obtain the most qualitative and relevant images.
Alford in view of Ramamurthy, alone or in combination, fail to teach a near-infrared spectroscopy ("NIRS") module positioned on the resilient substrate, in electrical communication with the controller, and configured for monitoring oxygenation status and/or biochemical measurements of the target site.
However, Kang teaches a wearable ultrasound and photoacoustic device to monitor health of a patient, or particularly a fetus wherein the device includes a component “to continuously emit light or emit light pulses… (e.g., near infrared (NIR) light pulses…) toward the tissue” [0027], where this biophotonic technique is used “to noninvasively monitor a cerebral oxygenation level or changes in blood flow within a brain” [0016].
Although Kang does not explicitly teach the position of the NIRS module to be on a resilient subtract in electrical communication with a controller, Kang does teach the application of NIRS in combination with an ultrasound device; therefore it would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford’s invention to incorporate the teachings of Kang to use a near-infrared spectroscopy ("NIRS") module positioned on the at least one resilient substrate, in electrical communication with the at least one controller, and configured for monitoring oxygenation status and/or biochemical measurements of the target site. One would be motivated to do this to do this monitor the health of a tissue so as to provide better treatment or diagnosis.
Alternatively, Walker teaches a diagnostic apparatus that includes a NIRS and ultrasound transducer wherein a near-infrared spectroscopy (“NIRS”) module (near infrared spectrophotometer 400) positioned on the resilient substrate in electrical communication with the controller and configured for monitoring oxygenation status and/or biochemical measurements of the target site (Column 2, lines 22-24: “A diagnostic apparatus includes a near infrared spectrophotometer and an ultrasound transducer that operate in combination to improve diagnostic measurements”, Column 10 – Column 12: the spectrophotometer measurement, blood flow measurement, and tissue blood gas measurement, Column 13, lines 22-25: “Combined optical-acoustic diagnostic apparatus 600 is an example of a near infrared spectrophotometer (NIRS) that is useful for tissue oxygenation monitoring.” )
Although Walker does not explicitly teach the position of the NIRS module to be on a resilient substrate in electrical communication with a controller, Walker does teach the application of NIRS in combination with an ultrasound device; therefore it would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Alford and Ramamurthy to incorporate the teachings of Walker to have a near-infrared spectroscopy (“NIRS”) module positioned on the resilient substrate in electrical communication with the controller and configured for monitoring oxygenation status and/or biochemical measurements of the target site, as these prior art references and the instant application are directed to diagnostic apparatus that utilizing ultrasound. One would be motivated to include NIRS to improve diagnostic measurements, as recognized by Walker(Abstract).
Regarding claim 2, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 1 (as shown above). Alford further discloses wherein the sensor is at least one of a piezoelectric or a micromechanical (“MEM”) sensor ([0067] “ultrasound transducers 56 may include a piezoelectric material…or micromachined ultrasonic transducers (CMUTS)…. ultrasound transducers 56 may additionally…include piezoelectric micro machines ultrasonic transducers (PMUTs)”).
Regarding claim 7, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 1 (as shown above). Alford further discloses the apparatus further comprising a coupling layer (adhesive layer 52) positioned in contact with a bottom surface of the ultrasound transducer and configured for selectively adhering the apparatus to the target site ([0068] “Adhesive layer 52 attaches wearable ultrasound device 50 to patient 12…is also configured to provide an acoustic interface between ultrasound transducers 56 and tissue of patient 12 for ultrasound”).
Regarding claim 9, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 1 (as shown above). Alford further discloses wherein the ultrasound transducer comprises a plurality of adjacently arranged sensors configured as an array (Fig. 2A).
Regarding claim 13, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 9 (as shown above). Alford further discloses wherein a subset of contiguous sensors are configured for being simultaneously activated on demand ([0034] “wearable ultrasound device 30 may control ultrasound transducers to target ultrasound energy to multiple different nerve tissues simultaneously”, [0005] “system may select appropriate transducers…system may trigger the start of ultrasound therapy delivery in response to detecting an event”, [0041])
Regarding claim 17, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 1 (as shown above). Alford further discloses wherein the EP module comprises at least one electrode array (Fig 2A), in electrical communication with at least one signal conditioning circuit (sensing circuitry 68, [0073] “sensing circuitry 68 may selectively receive and condition electrical signal produced sensors 76”), and configured for detecting bioelectric signals of the target site.
Regarding Claim 20, Alford teaches a wearable ultrasound apparatus positionable on a target site of a user's body and comprising (Fig. 2A wearable ultrasound device 50):
an ultrasound module configured for obtaining an ultrasound image of the target site, the ultrasound module comprising ([0039] “to receive reflected ultrasound energy to image anatomical structures”):
an ultrasound transducer (Fig 2A, ultrasound transducers 56) positioned on resilient substrate (Figure 2A, flexible interconnect element 54, [0060]), the ultrasound transducer comprising an at least one sensor ([0067] “ultrasound transducers 56 may additionally…include piezoelectric micro machines ultrasonic transducers (PMUTs)”);
a one conductive layer positioned in electrical communication with the at least one sensor ([0067] “In examples in which power sources 58 and ultrasound transducers 56 are attached, the ultrasound material may be glued or otherwise bonded to the surface of power source 58. In some examples, a metallic housing of power source 58 may be part of an electrical circuit of wearable ultrasound device 50”); and
an ultrasound transceiver in electrical communication with the at least one sensor; ([0053] “interface device 34 is configured to communicate e.g., via a wireless connection with wearable ultrasound device…may also be configured to communicate, e.g., via a wired or wireless connection, with implanted or wearable sensors”)
an electrophysiological ("EP") module (sensors 76) positioned on the resilient substrate and configured for detecting bioelectric signals of the target site ([0073] “in which wearable ultrasound device 60 is configured to sense physiological events wearable ultrasound device may include one or more sensors”, [0043] “the physiological event may include…electromyography (EMG) information, or a heart rate of patient”); and
a controller in electrical communication (communication circuitry 72) with each of the ultrasound module and the EP module via the conductive layers, the controller configured for selectively causing the ultrasound module to obtain an ultrasound image of the target site ([0071] “Processing circuitry 70 are configured to control ultrasound transducers 62 to deliver ultrasound energy, e.g., for a therapeutic or an imaging purpose”).
Although Alford does not explicitly teach a conductive layer positioned in electrical communication with the at least one sensor, Alford does teach a power supply possessing a metallic housing which is attached to the transducer (that could be a piezoelectric ultrasound transducer) and plays a part in the electric circuit. It is inherent that a metal can act as a conductor, therefore the Examiner interprets the metallic housing attached to the transducer as the conductive layer.
Alford fails to disclose the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of at least one of a bioelectric signal, an oxygenation status and/or a biochemical measurement in the target site and a near-infrared spectroscopy ("NIRS") module positioned on the resilient substrate, in electrical communication with the controller, and configured for monitoring oxygenation status and/or biochemical measurements of the target site.
However, Ramamurthy teaches an ultrasound imaging device wherein the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of at least one of a bioelectric signal, an oxygenation status and/or a biochemical measurement in the target site ([0107] “Ultrasound machine 400 may further comprise a trigger processing circuit 460 to receive physiological signals…an electrocardiogram (ECG) machine is connected to trigger processing circuit 460 through port 461. Trigger processing circuit 460 may process received physiological signals such as ECG signals in many way…A triggering circuit or system may also be included within trigger processing circuit 460. The triggering circuit may generate triggers in response to triggering events indicated in the received physiological signal. These triggers may be routed to controller 410 within ultrasound machine 400. If a triggering event occurs, trigger processing circuit 460 will receive an input through port 461 and transmit a signal to controller 410. Controller 410 may be programmed to start imaging when such a signal is received from trigger processing circuit 460. Controller 410 may be further programmed to image only for a certain set amount of time that may itself be programmable.”, [0167]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Alford with the teachings of Ramamurthy to have the controller configured for selectively causing the ultrasound module to obtain at least one ultrasound image of the target site upon detection of a bioelectric signal and/or electrophysiological parameter at the target site, as these prior art references are directed to ultrasound devices. One would be motivated to do this to obtain the most qualitative and relevant images.
Alford in view of Ramamurthy, alone or in combination, fails to teach a near-infrared spectroscopy (“NIRS”) module positioned on the resilient substrate and configured for monitoring oxygenation status and/or biochemical measurements of the target site and the controller in electrical communication with each of the ultrasound module and NIRS module via the conductive layers. .
However, Kang teaches a wearable ultrasound and photoacoustic device to monitor health of a patient, or particularly a fetus wherein the electromagnetic-evoked device has an optical component “to continuously emit light or emit light pulses… (e.g., near infrared (NIR) light pulses…) toward the tissue” [0027], where this biophotonic technique is used “to noninvasively monitor a cerebral oxygenation level or changes in blood flow within a brain” [0016]. Further, “the control device 110 may cause the ultrasound sensing component of the monitoring device 120 to sense signals generated from absorbers in the tissues of the patient that absorbed the energy emitted by the EM component of the monitoring device 120…Accordingly the, control device 110 may cause the ultrasound sensing component of monitoring device 120 to generate imaging data…The imaging data may be used to generate an image of the tissue” ([0027]).
Although Kang does not explicitly teach the position of the NIRS module to be on a resilient substrate in electrical communication with a controller, Kang does teach the application of NIRS in combination with an ultrasound device; therefore it would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford’s invention to incorporate the teachings of Kang a near-infrared spectroscopy (“NIRS”) module positioned on the resilient substrate and configured for monitoring oxygenation status and/or biochemical measurements of the target site and the controller in electrical communication with each of the ultrasound module and NIRS module via the conductive layers. One would be motivated to do this monitor the health of a tissue so as to provide better treatment or diagnosis.
Alternatively, Walker teaches a diagnostic apparatus that includes a NIRS and ultrasound transducer wherein a near-infrared spectroscopy (“NIRS”) module (near infrared spectrophotometer 400) positioned on the resilient substrate configured for monitoring oxygenation status and/or biochemical measurements of the target site (Column 2, lines 22-24: “A diagnostic apparatus includes a near infrared spectrophotometer and an ultrasound transducer that operate in combination to improve diagnostic measurements”, Column 10 – Column 12: the spectrophotometer measurement, blood flow measurement, and tissue blood gas measurement, Column 13, lines 22-25: “Combined optical-acoustic diagnostic apparatus 600 is an example of a near infrared spectrophotometer (NIRS) that is useful for tissue oxygenation monitoring.” ) and a controller in electrical communication with the NIRS module via the conductive layers (Column 6, lines 44-62).
Although Walker does not explicitly teach the position of the NIRS module to be on a resilient substrate in electrical communication with a controller, Walker does teach the application of NIRS in combination with an ultrasound device; therefore it would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Alford and Ramamurthy to incorporate the teachings of Walker to have a near-infrared spectroscopy (“NIRS”) module positioned on the resilient substrate configured for monitoring oxygenation status and/or biochemical measurements of the target site and a controller in electrical communication with the NIRS module via the conductive layers, as these prior art references and the instant application are directed to diagnostic apparatus that utilizing ultrasound. One would be motivated to include NIRS to improve diagnostic measurements, as recognized by Walker(Abstract).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of in view of Ramamurthy in view of Kang (or alternatively in view of Walker) as applied to claim 1 above, further in view of Xu et al. (WO 2020/176830 A1, previously cited), hereinafter Xu.
Regarding Claim 3, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 2, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach where the at least one sensor is a piezoelectric sensor comprising a piezoelectric material sandwiched between two or more electrodes.
However, Xu teaches a fully integrated smart wearable ultrasonic system where the at least one sensor is a piezoelectric sensor (1-3 piezo composite ultrasound array component 124) comprising a piezoelectric material (“any rigid piezoelectric material”, pg. 9 line 26) sandwiched between two or more electrodes (Cu/Zn electrode 126 and Cu electrode 128, Figure 3).
It would have been prima facie obvious for one of ordinary skill in the art at the time of applicant’s claimed invention to have modified Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) to incorporate the teaching of Xu to have the sensor be sandwiched between two or more electrodes. One would be motivated to do this as the electrodes can generate a voltage across the piezoelectric material. Examiner also notes that it is common practice that the piezoelectric material of the piezoelectric sensor is sandwiched between the electrodes therefore it would not have been an inventive step for one of ordinary skill in the art.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Ramamurthy further in view of Kang, or alternatively further in view of Walker as applied to claim 1 above, further in view of Sonnenschein (US Patent 12059294 B2, previously cited), hereinafter Sonnenschein.
Regarding Claim 4, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 1, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach wherein the ultrasound module further comprises a matching layer positioned on a bottom surface of the sensor configured for providing acoustic impedance adaption.
However, Sonnenschein teaches a wearable device that includes an ultrasound system with an “transducer array 14 (which) may also be covered by acoustic matching layers…to provide…acoustic matching” (Column 4, line 19-22)
It would have been prima facia obvious for one skilled in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker) to incorporate the teachings of Sonnenschein of having a matching layer positioned on a bottom surface of the at least one sensor and configured for providing acoustic impedance adaption. One would be motivated to do this for protection in addition to acoustic matching and beam focusing, as recognized by Sonnenschein. Additionally, Sonnenschein states that acoustic matching layers are common features of ultrasound systems therefore it would have been obvious to one skilled in the art to position and utilize the layer accordingly.
Regarding claim 5, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 1, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach wherein the ultrasound module further comprises a backing layer positioned in contact with a top surface of the at least one sensor furthest from the target site, the at least one backing layer configured for absorbing any ultrasound waves radiated by the at least one sensor that are not directed toward the target site.
However, Sonnenschein teaches “a backing layer is added between the transducer array 14 and the substrate 12 to absorb back emitted ultrasound waves from the transducer array 14” (Column 4, lines 9-13)
It would have been prima facia obvious for one skilled in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teachings of Sonnenschein to have a backing layer positioned in contact with a top surface of the at least one sensor furthest from the target site, the at least one backing layer configured for absorbing any ultrasound waves radiated by the at least one sensor that are not directed toward the target region. One would be motivated to do this because the backing layer to eliminate waves that are not meant to be transmitted to the tissue. Additionally, Sonnenschein states that backing layers are common features of ultrasound systems therefore it would have been obvious to one skilled in the art to position the layer accordingly.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Ramamurthy in view of Kang (or alternatively in view of Walker) as applied to claim 1 above, further in view of Xu et al. (US 2023/0355204 A1, previously cited), hereinafter Xu ‘204.
Regarding claim 6, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 1, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach an encapsulation later positioned to isolate the at least one conductive layer from the surrounding environment.
However, Xu ‘204 teaches a wearable ultrasonic-system-on-patch wherein the ultrasound module further comprises an encapsulation layer (Figure 1A: elastomer packaging) positioned to isolate the conductive layer from the surrounding environment ([0197] “the encapsulated USoP…including a stretchable ultrasonic probe…The ultrasonic probe consists of…an anisotropic conductive film (ACF)”, Figure 1A – 1B).
It would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teachings of Xu’204 to have an encapsulation layer positioned to isolate the conductive layer from the surrounding environment. One would be motivated to do this to protect the apparatus from deformation and damage, as recognized by Xu’204.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Ramamurthy in view of Kang (alternatively in view of Walker) as applied to claim 7 above, further in view of Hazra et al. (US 2017/0123487 A1, previously cited), hereinafter Hazra.
Regarding Claim 8, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches a wearable ultrasound apparatus of claim 7, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach the wearable ultrasound apparatus further comprising a coupling layer wherein the coupling layer has an acoustic impedance that approximates an acoustic impedance of the target site to provide impedance matching.
However, Hazra teaches a wearable system that includes an ultrasound transducer and transceiver with “…one or more polymer acoustic layers 30 functioning as an interface and disposed between band element 5 and the user's skin” ([0130]) where the “polymer acoustic layer 30 material is conformal, compliant and tacky to adhere uniformly with skin” ([0180]) and is responsible for “matching tissue acoustic impedances” ([0180]).
It would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teachings of Hazra to have a coupling layer that will adhere the apparatus to the target site and has an acoustic impedance that approximates an acoustic impedance of the target site so as to provide impedance matching. One would be motivated to do this to ensure that the acoustic waves or signals can be transferred efficiently from the target site to the sensor without loss of energy/signal. Additionally, it is noted that coupling layers are common features of ultrasound systems therefore it would have been obvious to one skilled in the art to position the layer accordingly.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Ramamurthy in view of Kang (alternatively in view of Walker) as applied to claim 9 above, further in view of Song et al. (US 2012/0277590 A1, previously cited), hereinafter Song.
Regarding claim 10, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 9 as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach wherein the ultrasound transducer comprises a plurality of arrays positioned in a side-by-side arrangement.
However, Song teaches a beamforming apparatus used in diagnostic image wherein the arrangement of these transducer arrays where they are positioned side-by-side (Figure 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to have incorporated the teachings of Song to have at least one ultrasound transducer comprise of a plurality of arrays positioned in a side-by-side arrangement because both prior arts and the instant are directed toward apparatuses that generate diagnostic images and have transducers. One would be motivated to do this because this improves the expandability of a beams reaching the target, as recognized by Song.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Kang as applied to claim 9 above, further in view of Kasahara (JP 2006006686 A, previously cited), hereinafter Kasahara.
Regarding claim 11, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 9 as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach wherein the ultrasound transducer comprises a plurality of arrays arranged to acquire orthogonal cross-sections of the target site.
However, Kasahara teaches an ultrasonic diagnostic apparatus with a plurality of scanning planes formed by a first array transducer and a second array transducer where the “first tray transducer is formed in parallel to the probe axis direction and a second array transducer formed in a direction orthogonal to the probe axis…the target tissue is observed with two cross sections orthogonal to each other” (Figure 3 and 13, [0002])
It would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teaching of JP’ 619 to have a plurality of arrays arranged so as to acquire orthogonal cross sections of the target site. One would be motivated to do this so that a complete image can be taken of the target tissue which characterizes the size, structure, and depth, as recognized by Kasahara.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Ramamurthy in view of Kang (alternatively in view of Walker) as applied to claim 1 and 9 above, further in view of Jiang et al. (US Patent 11877517 B2, previously cited), hereinafter Jiang.
Regarding Claim 12, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches the wearable ultrasound apparatus of claim 9, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach wherein the at least one array is configured as a curve.
However, Jiang teaches wherein the array is configured as a curve (Fig 18, Column 10, lines 4-9: “an application of the flexible piezo-composite transducer 100 of Fig. 16 affixed to a curved structure 130 according to various embodiments…the flexible piezo-composite transducer 100 conforms to the surface of the curved structure 130”).
It would have been prima facia to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teachings of Jiang to have an array configured as a curve. One would be motivated to do this in order for the transducer array to be able to conform and attach to the curved portions of our body, as recognized by Jiang.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Ramamurthy in view of Kang (alternatively in view of Walker) as applied to claim 9 above, further in view of Yamamoto et al. (WO 2020/188866 A1, previously cited), hereinafter Yamamoto.
Regarding Claim 14, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches a wearable ultrasound apparatus of claim 9, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach wherein a plurality of sensors are sandwiched between a plurality of electrodes arranged in a row-column configuration to form a quasi-two-dimensional array.
However, Yamamoto teaches a piezoelectric device that outputs and receives ultrasonic waves “a plurality of first electrode lines extending in the column direction…a plurality of second electrode lines extending in the row direction” (Abstract) in between which the piezoelectric array is held between (Fig. 2 piezoelectric array 10)
It would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teachings of Yamamoto to have the plurality of sensors sandwiched between a plurality of electrodes arranged in row-column configuration to form a quasi-two-dimensional array because both prior arts and the instant application are directed towards piezoelectric sensors that can receive and emit ultrasound wavelengths. One would be motivated to do this because it allows for the increase in vibration of the material and transfer of signal therefore producing a high-resolution and high-focused image, as recognized by Yamamoto.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford in view of Ramamurthy in view of Kang (alternatively in view of Walker) as applied to claim 1 above, in view of Maharbiz et al (US Patent 11033746 B2, previously cited), hereinafter Maharbiz.
Regarding claim 15, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches a wearable ultrasound apparatus of claim 1, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach wherein the apparatus comprises a greater quantity of sensors than ultrasound transceivers, such that the ultrasound transceiver is in electrical communication with a plurality of sensors.
However, JP’835 teaches an implantable device with ultrasound transducers where “in some embodiments, the transducer arrays contains more transducer elements than processing channels in the interrogator transmit/receive circuitry…64 transmit/receive channels connected to 192 physical transducer elements via a 3:1 multiplexer” (Column 24, lines 40-46) Examiner interprets the transmit/receive channels to be the transceiver and the transducer elements to be the sensors.
It would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teachings of JP’835 to have the apparatus comprise of a relatively greater quantity of sensors than ultrasound transceivers, such that the at least one ultrasound transceiver is in electrical communication with a plurality of sensors; as alternating or changing the number of transceivers or number of sensors is not an inventive step.
Regarding claim 16, Alford in view of Ramamurthy further in view of Kang (or alternatively further in view of Walker) teaches a wearable ultrasound apparatus of claim 15, as shown above. Alford, Ramamurthy, and Kang (alternatively Walker), alone or in combination, fail to teach the apparatus further comprising an at least one bidirectional multiplexer in electrical communication with the ultrasound transceiver and the corresponding plurality of sensors.
However, JP’835 teaches “64 transmit/receive channels connected to 192 physical transducer elements via a 3:1 multiplexer” (Column 24, lines 44-45). Examiner interprets the transmit/receive channels to be the transceiver and the transducer elements to be the sensors.
It would have been prima facia obvious to one of ordinary skill in the art at the time of applicant’s claimed invention to modify Alford, Ramamurthy, and Kang (alternatively Walker)to incorporate the teachings of JP’835 to have a bidirectional multiplexer in electrical communication with at least one ultrasound transceiver and the corresponding plurality of sensors, as it is known to one of ordinary skill that a multiplexer can be used for transmitting multiple data inputs to a single output. Although, JP’835 does not explicitly teach a bidi