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 09/17/2025, concerning Application No. 18/527,200. The amendments to the specification and the claims filed on 09/17/2025 are acknowledged. Presently, claims 1-8 and 10-21 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 09/17/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21, lines 1-3, the limitation “wherein the array of ultrasonic transducers is held in place on a human body comprising the target using an adhesive patch for coupling skin of the human body to the array of ultrasonic transducers” should be changed to “wherein the array of ultrasonic transducers is configured to be held in place on a human body comprising the target using an adhesive patch configured for coupling skin of the human body to the array of ultrasonic transducers”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 and 10-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: The claims are directed to a process and an apparatus, and therefore satisfy step 1 of the subject matter eligibility test.
Step 2A, Prong 1: The claims recite the following limitations that are directed to judicial exceptions (abstract ideas): “determining at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation” in claim 1 and similarly claims 2-3; “selecting an ultrasonic transducer of the array of ultrasonic transducers as exhibiting alignment with the target based at least in part on the at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation” in claim 1 and similarly in claims 12-16 and 18-20; and “determining a time of flight differential between subsequent reflected ultrasonic signals” in claim 18; etc., which recite either mathematical concepts and/or mental processes that can be performed in the human mind or with the aid of pen and paper.
Step 2A, Prong 2: This judicial exception is not integrated into a practical application because the generically recited computer elements do not add a meaningful limitation to the abstract idea (i.e., the mental processes and/or mathematical concepts) as the generically recited computer elements only amount to simply implementing the abstract idea on the machine. Additional elements recited at a high-level of generality include the array of ultrasonic transducers (claims 1, 4-8, and 10-21), etc., capable of performing the insignificant pre-extra solution activity of mere data gathering as claimed (i.e., “performing a plurality of instances of an ultrasonic scanning operation directed towards a target […] wherein each instance of the ultrasonic scanning operation transmits an ultrasonic signal and receives at least one reflected ultrasonic signal” in claim 1 and similarly claims 4-11 and 17), which are components recited at a high-level of generality that merely links the judicial exceptions to a particular technological environment and/or a computer as a tool to perform the abstract idea.
Step 2B: For similar reasons set forth above, the additional limitations also do not provide an inventive concept that would be substantially more than the judicial exception.
Conclusion: Claims 1-8 and 10-21 are not patent-eligible.
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 1-7, 14, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shurtliff et al. (US 2021/0169443 A1, of record, hereinafter Shurtliff).
Regarding claim 1, Shurtliff discloses a method of automatic alignment of a transversal ultrasound array, the method comprising:
performing a plurality of instances of an ultrasonic scanning operation directed towards a target using an array of ultrasonic transducers (see, e.g., Abstract, “Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy. When a user wears the device, the transducers are positioned near the brachial artery”, and Para. [0024], “The wearable monitoring device 100 utilizes two separate ultrasound transducer arrays (one proximal and one distal), each respectively housed in housings 108 and 110. The arrays operate to perform continuous wave Doppler ultrasound on the brachial artery. Although continuous wave Doppler is preferred, some implementations may utilize other modalities such as pulsed wave Doppler”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm”), wherein each instance of the plurality of instances of the ultrasonic scanning operation comprises a different sub-array of ultrasonic transducers of the array of ultrasonic transducers, a sub-array comprising a portion of ultrasonic transducers of the array of ultrasonic transducers (see, e.g., Para. [0059], “The microprocessor 450 is controllably linked to the transmission multiplexer 470 and operates to determine which particular subset of transmitter element(s) within the transmitter array 470 will be used to transmit the ultrasound wave into the user's tissue. The microprocessor 450 is also controllably linked to the receiving multiplexer 476 and operates to determine which particular subset of receiving element(s) within the receiver array 474 will be used to obtain the reflected Doppler signal”), and wherein each instance of the ultrasonic scanning operation transmits an ultrasonic signal and receives at least one reflected ultrasonic signal (see, e.g., Abstract, “Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm. Some of the ultrasound energy is reflected back to the receiver array 474. The reflected signal's frequency is shifted proportionally to the relative speed of objects in the transducer array's field of view (FOV), which includes blood flowing through the brachial artery past the transducer array. The receiver array 474 (or the selected subset of receiver elements within the array 474) receives the reflected ultrasound waves and operates to convert the ultrasound energy into an electronic voltage signal”);
determining at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation (see, e.g., Abstract, “Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy. When a user wears the device, the transducers are positioned near the brachial artery. The device operates to measure the transit time of a cardiac pulse through the brachial artery and across the fixed distance between transducer arrays. The measured pulse transit time may then be used for determining pulse wave velocity and/or blood pressure”, and Para. [0004], “The present disclosure describes monitoring systems, wearable monitoring devices, and related methods for determining a pulse transit time (PTT) that can optionally be used to estimate blood pressure. Pulse transit time (PTT) is the time it takes for a blood pressure pulse from a heartbeat to arrive at two different sites in the arterial tree. The obtained PTT measurements may also be utilized to determine pulse wave velocity (PWV) and/or blood pressure”, and Para. [0024-0026], and Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances”); and
selecting an ultrasonic transducer of the array of ultrasonic transducers as exhibiting alignment with the target based at least in part on the at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation (see, e.g., Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances”).
Regarding claim 2, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the at least one property includes at least one of a signal amplitude (see, e.g., Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances”), a phase, and a time of flight.
Regarding claim 3, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the at least one property comprises at least one of a Doppler signal amplitude (see, e.g., Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances”) and a Doppler velocity amplitude (see, e.g., Para. [0024], “The arrays operate to perform continuous wave Doppler ultrasound on the brachial artery. Although continuous wave Doppler is preferred, some implementations may utilize other modalities such as pulsed wave Doppler. The ultrasound arrays measure the velocity (e.g., to within a scale factor) of the blood flowing through the brachial artery”).
Regarding claim 4, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the array of ultrasonic transducers is placed transversely relative to the target (see, e.g., Para. [0009], “When the device is worn, the transducer arrays are oriented transverse (e.g., substantially orthogonal) to the brachial artery, increasing the likelihood that at least one ultrasound beam emanating from an array element will intersect a portion of the artery”, and Para. [0033], “FIG. 1B schematically illustrates placement of the device 100 on a user's arm 10. The housings 108 and 110 are positioned on the inner side of the arm 10 to be adjacent the brachial artery 11. Because the brachial artery 11 typically isn't straight and may vary from user to user, the housings 108 and 110 may be transversely adjusted to a position that improves the signal. Although individual users may vary in anatomy and/or in the particular way they wear the device, the adjustability of the housings 108 and 110 increases the odds that a suitable signal will be obtainable in a wide variety of applications”).
Regarding claim 5, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the sub-array of ultrasonic transducers comprises one ultrasonic transducer, such that each instance of the ultrasonic scanning operation transmits the ultrasonic signal at the one ultrasonic transducer and receives the at least one reflected ultrasonic signal at the one ultrasonic transducer (see, e.g., Para. [0059], “The microprocessor 450 is controllably linked to the transmission multiplexer 470 and operates to determine which particular subset of transmitter element(s) within the transmitter array 470 will be used to transmit the ultrasound wave into the user's tissue. The microprocessor 450 is also controllably linked to the receiving multiplexer 476 and operates to determine which particular subset of receiving element(s) within the receiver array 474 will be used to obtain the reflected Doppler signal”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm”).
Regarding claim 6, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the sub-array of ultrasonic transducers of each instance comprises a plurality of ultrasonic transducers (see, e.g., Para. [0059], “The microprocessor 450 is controllably linked to the transmission multiplexer 470 and operates to determine which particular subset of transmitter element(s) within the transmitter array 470 will be used to transmit the ultrasound wave into the user's tissue. The microprocessor 450 is also controllably linked to the receiving multiplexer 476 and operates to determine which particular subset of receiving element(s) within the receiver array 474 will be used to obtain the reflected Doppler signal”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm”).
Regarding claim 7, Shurtliff discloses the method of claim 6, as set forth above. Shurtliff further discloses wherein each instance of the ultrasonic scanning operation transmits the ultrasonic signal by beamforming using the plurality of ultrasonic transducers of the sub-array and receives the at least one reflected ultrasonic signal at one ultrasonic transducer of the plurality of ultrasonic transducers (see, e.g., Para. [0008], “Other more conventional arrays may alternatively be utilized, such as those that use beamforming”, and Para. [0009], “A transducer array may have a length of about 0.5 to 4 inches, or about 1 to 2.5 inches. When the device is worn, the transducer arrays are oriented transverse (e.g., substantially orthogonal) to the brachial artery, increasing the likelihood that at least one ultrasound beam emanating from an array element will intersect a portion of the artery. Alternatively, other arrays used in conventional ultrasound imaging could be used using phased array beamforming and associated ultrasound signal processing”, and Para. [0059], “The microprocessor 450 is controllably linked to the transmission multiplexer 470 and operates to determine which particular subset of transmitter element(s) within the transmitter array 470 will be used to transmit the ultrasound wave into the user's tissue. The microprocessor 450 is also controllably linked to the receiving multiplexer 476 and operates to determine which particular subset of receiving element(s) within the receiver array 474 will be used to obtain the reflected Doppler signal”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm. Some of the ultrasound energy is reflected back to the receiver array 474”).
Regarding claim 14, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target comprises: selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target that exhibits a largest signal amplitude of signal amplitudes of each instance of the ultrasonic scanning operation (see, e.g., Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances”).
Regarding claim 17, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the performing the plurality of instances of the ultrasonic scanning operation directed towards the target using the array of ultrasonic transducers comprises: transmitting sequential pulses for each instance of the plurality of instances of the ultrasonic scanning operation using each sub-array of ultrasonic transducers of the array of ultrasonic transducers, such that a reflected ultrasonic signal is received from the target for each transmitted pulse (see, e.g., Abstract, “Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy. When a user wears the device, the transducers are positioned near the brachial artery”, and Para. [0024], “The wearable monitoring device 100 utilizes two separate ultrasound transducer arrays (one proximal and one distal), each respectively housed in housings 108 and 110. The arrays operate to perform continuous wave Doppler ultrasound on the brachial artery. Although continuous wave Doppler is preferred, some implementations may utilize other modalities such as pulsed wave Doppler”, and Para. [0059], “The microprocessor 450 is controllably linked to the transmission multiplexer 470 and operates to determine which particular subset of transmitter element(s) within the transmitter array 470 will be used to transmit the ultrasound wave into the user's tissue. The microprocessor 450 is also controllably linked to the receiving multiplexer 476 and operates to determine which particular subset of receiving element(s) within the receiver array 474 will be used to obtain the reflected Doppler signal”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm. Some of the ultrasound energy is reflected back to the receiver array 474. The reflected signal's frequency is shifted proportionally to the relative speed of objects in the transducer array's field of view (FOV), which includes blood flowing through the brachial artery past the transducer array. The receiver array 474 (or the selected subset of receiver elements within the array 474) receives the reflected ultrasound waves and operates to convert the ultrasound energy into an electronic voltage signal”).
Regarding claim 19, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff further discloses wherein the selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target comprises: selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target that exhibits a largest signal amplitude of a Doppler signal (see, e.g., Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances”).
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.
Claims 8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff (US 2021/0169443 A1), as applied to claims 1 and 6-7 above, in view of Siedenburg (US Patent No. 11,642,106 B2, with effectively filed date 08/14/2017, hereinafter Siedenburg).
Regarding claim 8, Shurtliff discloses the method of claim 7, as set forth above. Shurtliff does not specifically disclose wherein the beamforming is defined according to time delays and apodization parameters of the array of ultrasonic transducers.
However, in the same field of endeavor of wearable and non-invasive ultrasound monitoring devices, Siedenburg discloses wherein the beamforming is defined according to time delays and apodization parameters of the array of ultrasonic transducers (see, e.g., Col. 5, lines 26-39, “The beamforming 154 generates a voxel, which is a three-dimensional volumetric pixel, using the reflected energy signal/data. The voxel generated by the beamforming 154 represents a volume of patient tissues interrogated by ultrasound energy, the reflection from which was received by the sensor 116. In this manner, a set of voxels is generated from the sensors 116, or a group of sensors 116, from the reflected energy signal/data. The beamforming 154 uses the time varying reflected energy signal/data from the sensor(s) 116, applies weights and delays to the reflected energy signal/data to generate the voxel. Multiple voxels are generated by beamforming 154 for the volume of interest, which is the volume being interrogated by the ultrasound module 112 of the sensing module 110”).
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 method of Shurtliff by including wherein the beamforming is defined according to time delays and apodization parameters of the array of ultrasonic transducers, as disclosed by Siedenburg. One of ordinary skill in the art would have been motivated to make this modification in order to desirably generate a voxel using the reflected ultrasound signal, as recognized by Siedenburg (see, e.g., Col. 5, lines 26-39).
Regarding claim 10, Shurtliff discloses the method of claim 6, as set forth above. Shurtliff does not specifically disclose wherein each instance of the ultrasonic scanning operation transmits the ultrasonic signal by generating an plane-wave using the plurality of ultrasonic transducers of the sub-array and receives the at least one reflected ultrasonic signal at one ultrasonic transducer of the plurality of ultrasonic transducers.
However, in the same field of endeavor of wearable and non-invasive ultrasound monitoring devices, Siedenburg discloses wherein each instance of the ultrasonic scanning operation transmits the ultrasonic signal by generating an plane-wave using the plurality of ultrasonic transducers of the sub-array and receives the at least one reflected ultrasonic signal at one ultrasonic transducer of the plurality of ultrasonic transducers (see, e.g., Col. 3, lines 55-67 and Col. 4, lines 1-10, “The pulser(s) 120 are electrically coupled to and can supply energy to the emitters 114 to cause the emitters 114 to generate and emit ultrasound energy. The pulser 120 can supply the energy at a power level to cause the ultrasound energy emitted by the emitters 114 to have a desired, or required, power level. Additionally, the pulser 120 can repeatedly activate the emitters 114 at varying power levels to vary the depth of tissue to which the ultrasound energy is transmitted and reflected. For example, the pulser 120 can be set to a tissue penetration depth of which all shallower depths of interest are in view and processed. The tissue penetration depth can be set by the power level. Further, the energy supplied by the pulser 120 can be a signal having various signal characteristics, such as a waveform, amplitude, frequency and/or wavelength, which can cause the ultrasound energy emitted by the emitters 114 to have desired, or required, signal characteristics. For example, the pulser 120 can cause the emitters 114 to emit ultrasound energy in a concerted manner, such as in the form of a plane wave. As discussed above, the pulser 120 can be connected to each emitter 114, or transducer, individually which can allow for the selective activation of one or more emitters 114 to emit ultrasound energy into the patient tissues”).
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 method of Shurtliff by including wherein each instance of the ultrasonic scanning operation transmits the ultrasonic signal by generating an plane-wave using the plurality of ultrasonic transducers of the sub-array and receives the at least one reflected ultrasonic signal at one ultrasonic transducer of the plurality of ultrasonic transducers, as disclosed by Siedenburg. One of ordinary skill in the art would have been motivated to make this modification in order to desirably generate a voxel using the reflected ultrasound signal, as recognized by Siedenburg (see, e.g., Col. 5, lines 26-39).
Regarding claim 11, Shurtliff modified by Siedenburg discloses the method of claim 10, as set forth above. Shurtliff does not specifically disclose wherein the generating the plane-wave is defined according to apodization parameters of the array of ultrasonic transducers.
However, in the same field of endeavor of wearable and non-invasive ultrasound monitoring devices, Siedenburg discloses wherein the generating the plane-wave is defined according to apodization parameters of the array of ultrasonic transducers (see, e.g., Col. 3, lines 55-67 and Col. 4, lines 1-10, “The pulser(s) 120 are electrically coupled to and can supply energy to the emitters 114 to cause the emitters 114 to generate and emit ultrasound energy. […] For example, the pulser 120 can cause the emitters 114 to emit ultrasound energy in a concerted manner, such as in the form of a plane wave…”, and Col. 5, lines 26-39, “The beamforming 154 generates a voxel, which is a three-dimensional volumetric pixel, using the reflected energy signal/data. The voxel generated by the beamforming 154 represents a volume of patient tissues interrogated by ultrasound energy, the reflection from which was received by the sensor 116. In this manner, a set of voxels is generated from the sensors 116, or a group of sensors 116, from the reflected energy signal/data. The beamforming 154 uses the time varying reflected energy signal/data from the sensor(s) 116, applies weights and delays to the reflected energy signal/data to generate the voxel. Multiple voxels are generated by beamforming 154 for the volume of interest, which is the volume being interrogated by the ultrasound module 112 of the sensing module 110”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Shurtliff modified by Siedenburg by including wherein the generating the plane-wave is defined according to apodization parameters of the array of ultrasonic transducers, as disclosed by Siedenburg. One of ordinary skill in the art would have been motivated to make this modification in order to desirably generate a voxel using the reflected ultrasound signal, as recognized by Siedenburg (see, e.g., Col. 5, lines 26-39).
Claims 12-13, 15-16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff (US 2021/0169443 A1), as applied to claim 1 above.
Regarding claims 12-13, 15-16, 18, and 20, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff discloses selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target based at least in part on the at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation, where the at least one property is specifically a signal amplitude and where the selecting the ultrasonic transducer is based on a largest signal amplitude of signal amplitudes of each instance of the ultrasonic scanning operation (see, e.g., Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances” (emphasis added)).
Shurtliff does not specifically disclose wherein the selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target comprises: selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target that exhibits: [1] a smallest time of flight of times of flight of each instance of the plurality of instances of the ultrasonic scanning operation (claim 12); [2] a largest time of flight of times of flight of each instance of the plurality of instances of the ultrasonic scanning operation (claim 13); [3] a smallest signal amplitude of the signal amplitudes of each instance of the ultrasonic scanning operation (claim 15); [4] a largest time of flight differential between a first reflected ultrasonic signal of the at least one reflected ultrasonic signal and a second reflected ultrasonic signal of the at least one reflected ultrasonic signal (claim 16); [5] the largest time of flight differential for each sub-array (claim 18); or [6] a largest width of a velocity profile identified from a Doppler signal (claim 20).
However, 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 method of Shurtliff by including selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting the alignment with the target that exhibits: [1] a smallest time of flight of times of flight of each instance of the plurality of instances of the ultrasonic scanning operation (claim 12); [2] a largest time of flight of times of flight of each instance of the plurality of instances of the ultrasonic scanning operation (claim 13); [3] a smallest signal amplitude of the signal amplitudes of each instance of the ultrasonic scanning operation (claim 15); [4] a largest time of flight differential between a first reflected ultrasonic signal of the at least one reflected ultrasonic signal and a second reflected ultrasonic signal of the at least one reflected ultrasonic signal (claim 16); [5] the largest time of flight differential for each sub-array (claim 18); or [6] a largest width of a velocity profile identified from a Doppler signal (claim 20), because as seen in MPEP § 2144.05, subsection II, under the header “Routine Optimization”, this would be seen as selecting the ultrasonic transducer of the array of ultrasonic transducers as exhibiting alignment with the target based on an optimized property of the reflected ultrasonic signal. This is evidenced by Shurtliff, where the selecting the ultrasonic transducer as exhibiting alignment with the target is based on a largest signal amplitude of signal amplitudes of each instance of the ultrasonic scanning operation (see, e.g., Para. [0044], “for a given reading, the transducer with the strongest signal may be selected…”). It is considered routine optimization because, as evidenced above in Shurtliff (where that invention’s selection is based on a largest signal amplitude), a person having ordinary skill in the art would do routine experimentation with the end result of an optimized property of the reflected ultrasonic signal (i.e., a smallest/largest time of flight, a smallest/largest signal amplitude, a largest time of flight differential, or a largest width of a velocity profile) that is determined in order to select the most optimal ultrasonic transducer of the array of ultrasonic transducers that would exhibit the most optimal alignment with the target based on that optimized property. See MPEP § 2144.05, subsection II(A).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff (US 2021/0169443 A1), as applied to claim 1 above, in view of Lewis, Jr. et al. (US 2022/0176163 A1, of record, cited in the Applicant’s IDS filed on 12/01/2023, hereinafter Lewis).
Regarding claim 21, Shurtliff discloses the method of claim 1, as set forth above. Shurtliff does not specifically disclose wherein the array of ultrasonic transducers is held in place on a human body comprising the target using an adhesive patch for coupling skin of the human body to the array of ultrasonic transducers.
However, in the same field of endeavor of wearable ultrasound devices, Lewis discloses wherein the array of ultrasonic transducers is held in place on a human body comprising the target using an adhesive patch for coupling skin of the human body to the array of ultrasonic transducers (see, e.g., Para. [0084-0085], “the ultrasound system further includes a securing component for keeping the ultrasound transducer array in place on a treatment surface of a subject […] the securing component can include, without limitation, a bandage, a wrap, an adhesive patch, a hydrogel coupling patch, or any other system for fixing the ultrasound transducer array in a desired location (e.g., a treatment area of the subject)”, and Para. [0095], “the ultrasound transducer array is fixed to the treatment area of a subject with an adhesive bandage”, and Para. [0108], “the ultrasound transducer array of the present disclosure is powered by an external power device and secured to a subject/patient (e.g., human or animal) via an adhesive bandage”).
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 method of Shurtliff by including wherein the array of ultrasonic transducers is held in place on a human body comprising the target using an adhesive patch for coupling skin of the human body to the array of ultrasonic transducers, as disclosed by Lewis. One of ordinary skill in the art would have been motivated to make this modification in order to provide a desirable securing component for keeping the ultrasound transducer array in place on a treatment surface of a subject, as recognized by Lewis (see, e.g., Para. [0084-0085], [0095], and [0108]).
Response to Arguments
Applicant's arguments, see Remarks filed 09/17/2025, have been fully considered but they are not persuasive.
Regarding Shurtliff (US 2021/0169443 A1), Applicant argues that Shurtliff does not disclose the claimed embodiments in the manner set forth in independent claim 1. Specifically, Applicant argues that Shurtliff does not disclose, and thus does not anticipate, “performing a plurality of instances of an ultrasonic scanning operation directed towards a target using an array of ultrasonic transducers, wherein each instance of the plurality of instances of the ultrasonic scanning operation comprises a different sub-array of ultrasonic transducers of the array of ultrasonic transducers, a sub-array comprising a portion of ultrasonic transducers of the array of ultrasonic transducers, and wherein each instance of the ultrasonic scanning operation transmits an ultrasonic signal and receives at least one reflected ultrasonic signal” and “selecting an ultrasonic transducer of the array of ultrasonic transducers as exhibiting alignment with the target based at least in part on the at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation” (emphasis added) as recited in independent claim 1.
Examiner respectfully disagrees and emphasizes that Shurtliff does disclose each and every limitation of independent claim 1, as set forth above. Specifically, Examiner emphasizes that Shurtliff discloses:
performing a plurality of instances of an ultrasonic scanning operation directed towards a target using an array of ultrasonic transducers (see, e.g., Abstract, “Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy. When a user wears the device, the transducers are positioned near the brachial artery” (emphasis added), and Para. [0024], “The wearable monitoring device 100 utilizes two separate ultrasound transducer arrays (one proximal and one distal), each respectively housed in housings 108 and 110. The arrays operate to perform continuous wave Doppler ultrasound on the brachial artery. Although continuous wave Doppler is preferred, some implementations may utilize other modalities such as pulsed wave Doppler”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm” (emphasis added)), wherein each instance of the plurality of instances of the ultrasonic scanning operation comprises a different sub-array of ultrasonic transducers of the array of ultrasonic transducers, a sub-array comprising a portion of ultrasonic transducers of the array of ultrasonic transducers (see, e.g., Para. [0059], “The microprocessor 450 is controllably linked to the transmission multiplexer 470 and operates to determine which particular subset of transmitter element(s) within the transmitter array 470 will be used to transmit the ultrasound wave into the user's tissue. The microprocessor 450 is also controllably linked to the receiving multiplexer 476 and operates to determine which particular subset of receiving element(s) within the receiver array 474 will be used to obtain the reflected Doppler signal” (emphasis added)), and wherein each instance of the ultrasonic scanning operation transmits an ultrasonic signal and receives at least one reflected ultrasonic signal (see, e.g., Abstract, “Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy”, and Para. [0060], “The transmitter array 472 (or the selected subset of transmitter elements within the array 472) are preferably operated in continuous wave (CW) mode, meaning the transmitter(s) are continuously transmitting the signal at the operating frequency. Although CW mode is preferred, other embodiments may be configured to operate in other modes, such as pulsed wave mode. The transmitted ultrasound signal radiates from the transmitter array 472 and propagates through tissues in the user's arm. Some of the ultrasound energy is reflected back to the receiver array 474. The reflected signal's frequency is shifted proportionally to the relative speed of objects in the transducer array's field of view (FOV), which includes blood flowing through the brachial artery past the transducer array. The receiver array 474 (or the selected subset of receiver elements within the array 474) receives the reflected ultrasound waves and operates to convert the ultrasound energy into an electronic voltage signal” (emphasis added));
determining at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation (see, e.g., Abstract, and Para. [0004], [0024-0026], and [0044]); and
selecting an ultrasonic transducer of the array of ultrasonic transducers as exhibiting alignment with the target based at least in part on the at least one property for each of the at least one reflected ultrasonic signal of each instance of the ultrasonic scanning operation (see, e.g., Para. [0044], “The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected. This may change from measurement to measurement, from one period of use to the next (e.g., if the user removes the device and later reattaches it in a slightly different position), and/or from user to user (e.g., due to anatomical differences or wearing preferences). The capability of selecting from among multiple transducer elements allows for effective operation of the device in a variety of circumstances” (emphasis added)).
Therefore, Shurtliff does disclose each and every limitation of independent claim 1, as set forth above.
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